2020

Transcatheter Pulmonary Valve Replacement With the Sapien Prosthesis

Transcatheter Pulmonary Valve Replacement With the Sapien Prosthesis Shahanavaz S, Zahn EM, Levi DS, Aboulhousn JA, Hascoet S, Qureshi AM, Porras D, Morgan GJ, Bauser Heaton H, Martin MH, Keeshan B, Asnes JD, Kenny D, Ringewald JM, Zablah JE, Ivy M, Morray BH, Torres AJ, Berman DP, Gillespie MJ, Chaszczewski K, Zampi JD, Walsh KP, Julien P, Goldstein BH, Sathanandam SK, Karsenty C, Balzer DT, McElhinney DB. J Am Coll Cardiol. 2020 Dec 15;76(24):2847-2858. doi: 10.1016/j.jacc.2020.10.041. PMID: 33303074   Take Home Points: Acute and limited short-term outcomes after TPVR with the Sapien valve were generally excellent in all types of RVOTs. There was a 10% rate of serious procedural adverse events and 1.7% per patient year rate of endocarditis occurring up to 16 months post valve implant. The question of native RVOT pre-stenting remains unresolved but use of a Gore DrySeal should be encouraged to minimize tricuspid valve injury.   Commentary from Dr. Konstantin Averin (Edmonton), chief catheterization section editor of Pediatric Cardiology Journal Watch: Two valve systems are currently FDA approved for transcatheter pulmonary valve replacement (TPVR) in the US – the Melody valve (Medtronic, Minneapolis, MN) and the Edwards Sapien Valve (Edwards Lifesciences, Irvine, California). There is robust data on outcomes with the Melody valve (up to 10 years follow up) but large series describing even procedural outcomes of 2nd (XT) and 3rd (S3) generation Sapien valve implantation are lacking. In this paper, Dr. Shahanaz and her co-authors report on procedural and short-term outcomes of the XT and S3 valves from a large retrospective unaudited registry – COMPASSION S3 (Evaluation of the Sapien S3 Transcatheter Heart Valve in Patients with Pulmonary Valve Dysfunction).   From January 1, 2008 to August 28, 2019 774 patients from 23 centers underwent attempted TPVR (defined as valve introduced into the body). Technical success (no death or explant within 24 hours) was achieved in 97.4% and clinical success (technical success with less than moderate PR and peak Doppler gradient <40 mmHg) in 89%. Most patients were between 12-50 years of age (78%) with an equal number <12 and >50. Almost exactly half of patients had native/patched RVOTs with the remainder having a conduit or stented bioprosthetic valve. The most common diagnosis was tetralogy of Fallot with a variety of other RVOT pathologies. An S3 valve was used in 78% of cases with an XT used in the remainder. Valve delivery was via the femoral route in 93% of cases and a long Gore DrySeal sheath used in at least 152 (20%) – potentially more as this was not a specific data field. The Gore DrySeal sheath is increasingly utilized to facilitate valve delivery to the RVOT and minimize the risk of tricuspid valve injury. Slightly more patients in the entire cohort had a pre-stent implanted than not (54% v 46%) and in a similar ratio was found in the native RVOT group (59% v 41%).   Of the 20 technically unsuccessful procedures – 4 had a valve introduced but not implanted, 14 had the valve removed within 24 hours, and 2 died from pulmonary artery rupture. Not surprisingly, patients less than 30kg were less likely to have a technically successful procedure (90.4% v 97.9%, p = 0.008). Serious procedural adverse events occurred in 67 patients (10% of those with available data) – 11 (1.7%) with tricuspid valve injury (1/20 using DrySeal sheath); 30 (4.5%) with valve or stent embolization (12 requiring surgery); only 2 patients with coronary artery or aortic root compression requiring urgent surgery and a small number of other complications. Importantly, 9 patients were diagnosed with endocarditis 0.2 months to 16 months post-valve implant (1.7% per patient-year) which is slightly but not significantly better than the rate reported with Melody valve (~2-3% per year).   Acute and limited short-term outcomes after TPVR with the Sapien valve were generally excellent in all types of RVOTs. There are important complications that operators need to consider and take steps to mitigate when possible. The question of whether to pre-stent (especially in native RVOTs) remains unanswered as does the question of endocarditis risk (relative to the Melody valve). It does seem that use of a Gore DrySeal sheath minimizes the risk of tricuspid valve injury and its use should be considered until alternative delivery systems are available.   

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Use of institutional criteria for transcatheter device closure of Fontan fenestration – Midterm outcomes

Use of institutional criteria for transcatheter device closure of Fontan fenestration - Midterm outcomes Nikhil Thatte 1, Vivian Dimas 2, Alan Nugent 3, Thomas Zellers 2, Joseph Forbess 4, Luis Zabala 5, Song Zhang 6, Surendranath R Veeram Reddy 2 Ann Pediatr Cardiol. Oct-Dec 2020;13(4):327-333. doi: 10.4103/apc.APC_154_19. Epub 2020 Sep 21. PMID: 33311921; PMCID: PMC7727914; DOI: 10.4103/apc.APC_154_19 Free PMC article   Take Home Points: Fontan fenestration closure may be considered in patients with favourable hemodynamics. This retrospective review demonstrates that in the first few years after Fontan operation, using strict inclusion criteria there is an improvement in systemic saturations with no increase in the adverse events.   Commentary from Dr. Varun Aggarwal (Minneapolis, MN, USA), section editor of Congenital   Heart Disease Interventions Journal Watch: First reported in 1971 in the journal Thorax by Dr. Francis Fontan and Dr. Eugene Baudet on a patient with tricuspid valve atresia as a procedure to “transmit the whole vena cava blood to the lungs while only oxygenated blood returns to the left heart”. This operation has since been commonly referred to as ‘Fontan operation’ and has been performed in many children born with a variety of different congenital heart lesions. A significant physiological change in the postoperative period is sometimes complicated by low cardiac output syndrome and pleural effusions. Creation of a small connection between the Fontan conduit and the atrium can allow some right to left shunting across the fenestration and improve cardiac output decreased incidence of pleural effusions.   One of the commonly debated topics is the decision is ‘if and when’ to close these Fontan fenestrations. In this retrospective review by Thatte et al, patients who underwent fenestrated Fontan procedures from 2005 to 2015 were classified into three groups [Group A (n=42): those who underwent fenestration closure, Group B (n=10): fenestration closure deferred due to failure to meet the criteria for fenestration closure and Group C (n=150): patients not referred for cardiac catheterization as controls]. Criteria used for fenestration closure by authors included 1) anatomically unobstructed Fontan pathway with no significant decompressing systemic to pulmonary veno-venous collaterals; (2) baseline Fontan pressure ≤15 mmHg; (3) baseline cardiac index ≥2 L/min/m2; and (4) decrease in cardiac index ≤20% from baseline with test occlusion of the Fontan fenestration.   The cardiac catheterization procedure was performed at a median 28 months after Fontan operation for Group A and 59 months for group B. Acutely, the mean Fontan pressure increased from 13.1 ± 2.1 to 14.5 ± 2.1mmHg in Group A and 14.6 ± 1.5 to 15.7 ± 2.2 mmHg in Group B (P = not significant). With test occlusion, cardiac index fell by 18.12% ± 15.68% in Group A and 33.75% ± 14.98% in Group B (P = 0.019). Interestingly the main difference in the two groups was the more pronounced fall in the cardiac index in Group B. At a median of 46-month follow-up, oxygen saturation increased significantly from 85.15% ± 6.29% at baseline to 94.6% ± 4.43% (P < 0.001) in Group A but with no statistically significant difference in the rates of plastic bronchitis, protein-losing enteropathy, or heart transplantation between the three groups. There was no reduction in the incidence of stroke observed in this cohort after closure of the Fontan fenestration.   Closure of Fontan fenestration using the above-mentioned criteria (within the first few years after Fontan operation) may result in an increase in systemic oxygen saturations without any increased incidence of long-term adverse outcomes like death, transplantation, protein losing enteropathy or plastic bronchitis. Whether this is true for patients further out from the Fontan operation remains a matter of discussion.   FIGURE 1 A digital subtraction angiogram of a patient with an extracardiac Fontan conduit demonstrating the persistent open Fontan fenestration (arrow) with right to left shunting. This patient had narrowing of the Fontan conduit as well as the left pulmonary artery which were stented, but the fenestration was left open at this cardiac catheterization.     

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Pediatric/Congenital Cardiac Catheterization Quality: An Analysis of Existing Metrics

Pediatric/Congenital Cardiac Catheterization Quality: An Analysis of Existing Metrics O'Byrne ML, Huang J, Asztalos I, Smith CL, Dori Y, Gillespie MJ, Rome JJ, Glatz AC. JACC Cardiovasc Interv. 2020 Dec 28;13(24):2853-2864. doi: 10.1016/j.jcin.2020.09.002. PMID: 33357522   Take Home Points: Existing quality metrics in the pediatric cardiac catheterization lab nearly all currently focus on safety, either as an outcome (adverse events, radiation, etc.) or as a safety structure (procedural volume, operator experience). There is not currently a good metric for procedural efficacy, despite this measure being a perceived priority by practicing interventionalists. Risk adjustment is particularly important when comparing outcomes between and within centers, in the heterogenous world of congenital heart disease, however there is little confidence among interventionalists about current risk-adjustment methodologies.   Commentary from Dr. Wendy Whiteside (Ann Arbor, MI, USA), section editor of Congenital Heart Disease Interventions Journal Watch: In this article, O’Byrne et al provide a systematic evaluation of the current state of quality metrics in the pediatric cardiac catheterization lab (PCCL). Their review involved evaluation of quality metrics via 3 mechanisms: 1. Review of peer-reviewed research, 2. Review of metrics from organizations/professional societies interested in quality, and 3. Survey of pediatric interventional cardiologists in the US. This manuscript provides insight into many of the deficiencies of the current quality landscape in the PCCL.   All of the metrics identified in the 9 papers reviewed, were related to patient safety. The majority of these were related to outcome metrics including adverse events, failure to rescue, and radiation, with the remainder (33%) of the references referring to safety structures including procedural and operator volume and experience. While there is no question that safety is of paramount importance in a procedural space such as the PCCL, there are multiple other areas of quality in the Institute of Medicine Quality Domains (including effectiveness, efficiency, timeliness, equity, and patient-centeredness) which are currently voids in the PCCL quality literature and need to be areas of future study within this field. Additionally, consensus on the structures and processes associated with good quality care in the PCCL needs to be reached.   Among quality-measuring organizations/societies, a minority (only 4, 22%) propose or measure quality metrics from PCCL programs. The majority of the US News & World Report score for pediatric cardiology and cardiovascular surgery programs involving the cath lab are related to procedural volume and not at all to procedural safety or efficacy. This is a problem as this tells only part of the story related to the quality of a particular program’s cath lab. Part of why this problem likely exists is because good metrics for procedural safety, and even more so, for procedural efficacy don’t currently exist for many procedures. Three existing registries, including the IMPACT registry, the Congenital Cardiac Catheterization Project on Outcomes (C3PO) collaborative, and the Congenital Cardiovascular Interventional Study Consortium (CCISC) Risk Registry, provide member institutions their own quality metrics for review, but none are flawless. The IMPACT registry, while large, is not risk -adjusted and includes a simplified dichotomy for procedural success which is not clinically useful for many of the procedures evaluated. C3PO reports provide risk adjusted adverse events and radiation data and allows for comparison to other member institutions, but is limited in its scope with only a small subset of programs participating. While safety has been the focus, is reported by the 3 physician organized registries (IMPACT, C3PO, and CCISC), and is a stated priority of the surveyed interventionalists, there is still not consensus on how to properly measure this, with the majority of survey respondents not confident with the effectiveness of current risk adjustment methodologies.   When we look at areas within pediatric cardiology who have done well with collecting, using, and acting on quality data, cardiac intensive care (PC4—the Pediatric Cardiac Critical Care Consortium) and cardiac surgery (STS—the Society of Thoracic Surgeons—Congenital Database) are two areas to learn from. While the PCCL still has room to improve on risk adjustment methodologies, much work also needs to be focused on procedural efficacy and providing a metric that can account for the subtleties of procedural outcomes in this field (Less residual aortic stenosis after aortic balloon valvuloplasty may not be better if it creates more aortic insufficiency). Additionally, trust and transparency in the data is necessary and will need to be built into existing registries moving forward. While our intentions in assessing PCCL quality have always been true, the focus now needs to be on tackling the more challenging metrics to define and measure. We need to move as a field towards better defining those metrics we know are important to us, and how best to measure and compare these to allow for learning and improvement in the field as a whole.   

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Trans-catheter atrial septal defect closure with the new GORE® Cardioform ASD occluder: First European experience

Trans-catheter atrial septal defect closure with the new GORE® Cardioform ASD occluder: First European experience. Santoro G, Castaldi B, Cuman M, Di Candia A, Pizzuto A, Sirico D, Cantinotti M, Garibaldi S, Pak V, Di Salvo G.Int J Cardiol. 2020 Nov 18:S0167-5273(20)34152-8. doi: 10.1016/j.ijcard.2020.11.029. Online ahead of print.PMID: 33220363   Take Home Points: The GORE® Cardioform ASD Occluder device (WL Gore & Associates, Flagstaff, AZ) was recently approved by the USA Food and Drug Administration in June 2019 for closure of ostium secundum atrial septal defects (up to 35 mm in diameter). This is a Prospective observational study at two Italian Pediatric Cardiology centers (43 patients) using the Gore Cardioform ASD occluder from January to June 2020. Device deployment was successful in 97.7% patients with complete closure rate of 92.9% at 1 month follow up (all residual shunt was reported trivial).   Commentary from Dr. Varun Aggarwal MBBS MD (University of Minnesota Masonic Children’s Hospital, Minneapolis, MN), catheterization section editor of Pediatric Cardiology Journal Watch: Transcatheter closure of ostium secundum atrial septal defect is preferred if the defect rims are deemed appropriate for device closure. Till recently, Amplatzer® atrial septal occluder (Abbott Laboratories, IL) is the most commonly used device for secundum atrial septal defect closure in United States. One of the interventionalist nightmare is the (albeit low) risk of erosion of the Amplatzer atrial septal defect occluder leading to pericardial effusion which can be life threatening in some cases. Therefore, some operators prefer to use the (non-self-centering) Gore® Cardioform Septal occluder (WL Gore & Associates, Flagstaff, AZ) approved initially for closure of ASD’s smaller than 17mm in 2015.   The GORE® Cardioform ASD Occluder device (WL Gore & Associates, Flagstaff, AZ) was recently approved by the USA Food and Drug Administration in June 2019 for closure of ostium secundum atrial septal defects, Figure 1. It has as a significant technical innovation in trans-catheter ASD treatment since it combines high softness and anatomic compliance with the potential to close defects as large as 35 mm.   In this prospective observational report by Santoro G et al, 43 patients with hemodynamically significant ASD were evaluated for closure using the Gore Cardioform ASD occluder from January to June 2020. Median age of the cohort was 9.9 years with a median ASD diameter of 10mm (range 10-28mm). Successful device deployment was achieved in 42/43 patients (97.7%). Major adverse events were recorded in 3 patients (7.0%) (one case of early embolization which required emergent cardiac surgery; one case of variable atrio-ventricular block which spontaneously subsided in a few minutes; one case of sustained supra-ventricular tachycardia responsive to antiarrhythmic therapy). Complete ASD closure was found in 78.6% of cases (33/42 pts) at the time of hospital discharge, rising to 92.9% (39/42 pts) at the 1-month follow-up evaluation. Residual shunt was always trivial and intra-prosthetic, even in the patients with multi-fenestrated septum submitted to ASD closure with a single device.   Authors report that the “deployment of this device was somehow technically more challenging than other devices just because of its softness and respectfulness of local anatomy that prevents its self-accommodation inside atrial septum”. In patients with large defects and deficient rims, some variation in delivery technique using a long Mullins sheath (personal experience) has been useful to help align the device parallel to the atrial septum during deployment. Use of both echocardiographic and fluoroscopic guidance is essential during the device deployment. In the study, the rate of complete closure was significantly lower than other reports but significantly improved at the 1-month evaluation, probably due to device endothelial coverage or its slow adaptation to ASD anatomy. No cardiac or extracardiac adverse events were recorded over a short-term follow-up. On-going long-term surveillance with echocardiogram and chest x-ray (for wire frame fracture) is important in the follow up of these patients.   FIGURE 1   Deployment steps of the Gore Cardioform ASD occluder across the atrial septal defect. The device has a conformable waist and is self-centering in nature. Images were provided courtesy of W. L. Gore & Associates.   

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Single center experience of pediatric percutaneous balloon pericardiotomy

Single center experience of pediatric percutaneous balloon pericardiotomy. Herron C, Forbes TJ, Kobayashi D.Cardiol Young. 2020 Nov 3:1-4. doi: 10.1017/S1047951120003686. Online ahead of print.PMID: 33140718   Take Home Points: Percutaneous balloon pericardiotomy is a feasible alternative to surgical pericardial window creation in the pediatric population. Although technical success was excellent in this manuscript, re-interventions were common and some patients did require subsequent surgical pericardial window creation.   Commentary from Dr. Arash Salavitabar (Ann Arbor MI, USA), catheterization section editor of Pediatric Cardiology Journal Watch: The authors report on a retrospective single-center experience with percutaneous balloon pericardiotomy (PBP) in children with the goal of creating a non-surgical pericardial window, a relatively unique procedure in the pediatric population. Technical success was defined as achievement of a pericardial window by this technique, judged by identification of the balloon waist at the parietal pericardium and following disappearance of this balloon waist. Procedural success was defined as resolution of the pericardial effusion without need of subsequent surgical pericardial window.   The technique described by the authors was performed in 11 patients with a median age of 12 years (range 1.8-19) and median weight of 50kg (12-.3-122). The approach involves a standard pericardiocentesis with subsequent placement of a 0.035” Rosen wire (Cook Medical, Bloomington, IN) into the pericardial space. The skin tract is dilated with an 8-10Fr dilator, and then serial dilation is performed with balloons situated across the pericardium. A mid-balloon waist is observed via gentle inflation and by fluoroscopy to confirm position and the ultimate balloon diameter is chosen based on the goal diameter. Some patients required two simultaneous balloon catheter inflations to achieve that goal diameter. Contrast injections were used to visualize the pericardial space and margin of the parietal pericardium. A pericardial drain was left in most patients.       Four of the 11 patients were post-pericardiotomy syndrome patients at a median 58 days (39-88) post-cardiac surgery and 4 required percutaneous re-interventions (4 pericardiocentesis in 3 patients and 2 PBPs in 2 patients) due to re-accumulation of the pericardial effusion. Three of those patients who required percutaneous re-interventions also required subsequent surgical pericardial window creation. The majority of PBPs were performed with compliant balloons (e.g., Tyshak II, Z-Med), however two received PBP using relatively non-compliant balloons (e.g., Atlas, Powerflex). The largest balloon diameter used ranged from 8 to 20mm; 20mm was the final dilation diameter in most older children. Echocardiography was used to confirm improvement in pericardial effusion.   Based on these results, the authors reported a technical success of 100% with no acute complications, an overall procedural success of 73%, and 45% re-intervention rate. Of note, 4/11 patients showed development of a left pleural effusion post-PBP, but did not require chest tube placement. The authors describe that this procedural success rate and re-intervention rate may be explained by the fact that a “torn” pericardium by PBP is not a permanent anatomic solution. The other possible contributing factors described were final balloon size, inability to completely expand the balloon based on position against chest wall, residual waist, or the etiology of the underlying effusion.   The approach of percutaneous balloon pericardiotomy is certainly an enticing alternative to surgical pericardial window creation and the authors describe a technique that is certainly plausible in many patients with pericardial effusions. Based on these results, the care team and proceduralist must understand that re-interventions are relatively common with this procedure, but may preclude the need for more invasive surgical interventions in some patients. Given the heterogeneity in their reported patient population and the potential for variable results, larger studies will be of benefit to better understand its utility, as well as risk factors for procedural failure and complications.    

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Utility of the long DrySeal sheath in facilitating transcatheter pulmonary valve implantation with the Edwards Sapien 3 valve

Utility of the long DrySeal sheath in facilitating transcatheter pulmonary valve implantation with the Edwards Sapien 3 valve Fukuda T, Tan W, Sadeghi S, Lin J, Salem M, Levi D, Aboulhosn J. Catheter Cardiovasc Interv. 2020 Feb 19. doi: 10.1002/ccd.28776. [Epub ahead of print] PMID: 32073725 Similar articles Select item 32073720   Take Home Points: The traditional delivery approach for implantation of the Edwards Sapien 3 valve in the pulmonary position comes with risks of tricuspid valve injury and need for additional steps for advancement of the valve into proper position. The modified technique of using a Gore DrySeal long sheath for valve delivery, instead of the recommended Edwards expandable sheath (e-sheath), can decrease delivery time, increase procedural safety, and improve ease of retrieval of ruptured balloons.   Commentary from Dr. Arash Salavitabar (Ann Arbor MI), catheterization section editor of Pediatric Cardiology Journal Watch: Percutaneous transcatheter pulmonary valve implantation (TPVI) with the Edwards Sapien 3 (S3) valve is a well-described procedure that clearly fills a void in TPVI choices for patients with congenital heart disease. Tricuspid valve (TV) injury is a known complication TPVI with the Edwards S3 valve when using the recommended Edwards expandable sheath (e-sheath). This risk is thought to be increased due to the need to advance an uncovered, balloon-mounted stented valve across the tricuspid valve and into the right ventricular outflow tract (RVOT) with this system. The authors report on single-center outcomes of an off-label modified delivery technique, which involves the use of a Gore DrySeal long sheath, in place of the standard e-sheath, for delivery of the S3 valve.   Of the 94 patients who underwent percutaneous implantation of the S3 valve in the pulmonic position during an approximately 4-year period, the DrySeal sheath was utilized in 29 patients (30.8%). The most common (38.3%) landing zone was a patched, or “native”, RVOT. Pre-stents were utilized in 1/3 of patients, most often in the setting of a RV-to-PA conduit.   The authors found that valve delivery time (time from insertion of S3 valve into sheath to valve deployment) was shorter in the DrySeal group when compared to the e-sheath group (median 4 min 33 sec vs. 9 min 6 sec, p=0.002). The delivery time was reported to be longest with the first 2 patients of center’s experience with utilizing the DrySeal sheath for this indication, and this was thought to be secondary to not obtaining sheath position distal enough into the MPA or proximal branch pulmonary artery prior to valve insertion. Those cases were complicated by the sheath dropping into the RV cavity, resulting in ventricular arrhythmias and valve delivery similar to the steps taken when using the e-sheath. Delivery times were improved once the technical adjustment was made to obtain more distal sheath position. Median fluoroscopy time was shorter for the DrySeal group as well (median 33 min 24 sec vs. 44 min 1 sec, p=0.04).   There was a significantly higher rate of complications in the e-sheath group (13.9% vs. 0%, p=0.04). Notably, the 2 types of complications that are thought to be protected against by utilizing the DrySeal sheath comprised 5 of 9 acute procedural complications in the e-sheath group: tricuspid valve injury (4) and femoral venous dissection (1). Importantly 3 of the 4 TV injuries ultimately required surgical intervention. Additionally, 2 cases were reported in which retrieval of a ruptured delivery balloon was difficult with the e-sheath and resulted in embolization of the tip of the e-sheath in one and TV injury in the other.   Although this is an initial single-center experience with this modified delivery technique for TPVI with the Edwards Sapien 3 valve, the authors present promising results of decreased procedural time and safety with this approach.        

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Implantable pulmonary artery pressure monitoring device in patients with palliated congenital heart disease: Technical considerations and procedural outcomes

Implantable pulmonary artery pressure monitoring device in patients with palliated congenital heart disease: Technical considerations and procedural outcomes Salavitabar A, Bradley EA, Chisolm JL, Hickey J, Boe BA, Armstrong AK, Daniels CJ, Berman DP. Catheter Cardiovasc Interv. 2020 Feb;95(2):270-279. doi: 10.1002/ccd.28528. Epub 2019 Oct 14. PMID: 31609082   Take Home Points: Patient with complex congenital heart disease increasingly survive into adulthood and experience significant morbidity related to heart failure. Use of implantable hemodynamic monitor (CardioMEMS™) in this patient population is feasible and safe and allows for continuous tracking of pulmonary artery pressures. More work needs to be done to assess the long-term safety and clinical utility of such devices.     Commentary from Dr. Konstantin Averin (Edmonton), catheterization section editor of Pediatric Cardiology Journal Watch: Heart failure (HF) causes significant morbidity in adults with congenital heart disease (CHD). In non-CHD populations the use of implantable hemodynamic monitors (IHM) has been shown to decrease HF-related hospitalizations. To date, the use of these devices in CHD patients has been very limited. The authors sought to describe a single center experience utilizing IHM’s in adult patients with complex CHD – focusing on technical aspects and procedural outcomes.   The authors utilized the CardioMEMS™ device (Abbott Medical, Chicago, IL; picture below), a radiopaque sensor which is delivered via a 12 French sheath over a 0.018”wire and is anchored in a branch pulmonary artery (target diameter 7-15 mm) by a nitinol loop at each end. Fourteen patients (35.5 ± 9.2 years; 72 ± 12 kg) met inclusion criteria (adult with complex CHD; NYHA FC III HF; and at least one decompensated HF admission referred for hemodynamic catheterization) and underwent successful implant of the CardioMEMS™ device. All patients had either Fontan (n = 8) or d-TGA s/p atrial switch (6) anatomy. The devices were implanted via a femoral vein in most (13/14) and a long sheath was utilized in slightly more than half (8/14). A long sheath was particularly useful when advancing the device in patients who had undergone a Mustard operation (5/8). The device was implanted in the LPA in most patients (12/14) due to easier calibration and subsequent data transmission in this location.   Calibration and subsequent data transmissions were accomplished in all patients. One patient required recalibration (with hemodynamic catheterization) due to significant changes in IHM transmissions. There was one major complication – device migration from the LPA to the RPA – with no clinical sequelae.   The use of IHM’s in patients with CHD is almost non-existent, even though invasive hemodynamics in this patient population are often felt to not be truly representative of patients in their daily lives. The authors have nicely demonstrated that despite the complex anatomies of adults with CHD, IHM implantation is feasible and safe in this patient population. Further studies are clearly needed to demonstrate long-term safety of these devices as they will likely remain in place forever and whether they will improve clinical outcomes.      

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Procedural, pregnancy, and short-term outcomes after fetal aortic valvuloplasty

Procedural, pregnancy, and short-term outcomes after fetal aortic valvuloplasty Patel ND, Nageotte S, Ing FF, Armstrong AK, Chmait R, Detterich JA, Galindo A, Gardiner H, Grinenco S, Herberg U, Jaeggi E, Morris SA, Oepkes D, Simpson JM, Moon-Grady A, Pruetz JD. Catheter Cardiovasc Interv. 2020 Mar 26. doi: 10.1002/ccd.28846. PMID: 32216096 Similar articles Select item 32215649   Take Home Points: Fetal aortic valvuloplasty offers promise in patients with congenital aortic stenosis to prevent progression to hypoplastic left heart syndrome It is a high risk intervention and center experience is crucial to maximizing success Further investigation of outcomes in patients who undergo fetal aortic valvuloplasty but still require single ventricle palliation is warranted     Commentary from Dr. Ryan Romans (Kansas City, MO), section editor of Congenital Heart Disease Interventions Journal Watch: Fetal aortic valvuloplasty (FAV) was first reported in 1991 as an option to treat congenital aortic stenosis in mid-gestation fetuses with the goal to prevent progression to hypoplastic left heart syndrome (HLHS). The process involves using ultrasound guidance to puncture through the maternal abdomen and uterus, then into the fetal thigh to deliver analgesia and a muscle relaxant. A different needle is then passed through the fetal chest and into the left ventricle. A wire is advanced through the needle across the aortic valve. A balloon is advanced over the wire and inflated across the aortic valve. Most centers performing fetal aortic valvuloplasty perform a small number of cases. Boston Children’s Hospital has performed the largest number of these cases and have previously reported their procedural outcomes (Freud LR, McElhinney DB, Marshall AC, et al. Fetal aortic valvuloplasty for evolving hypoplastic left heart syndrome: postnatal outcomes of the first 100 patients. Circulation. 2014;130(8):638-645 and Friedman KG, Sleeper LA, Freud LR, et al. Improved technical success, postnatal outcome, and refined predictors of outcome for fetal aortic valvuloplasty. Ultrasound Obstet Gynecol. 2018;52(2):212-220), as have several other smaller single center studies. Procedure related fetal mortality rates are variable across centers (6.5-32.1%). The International Fetal Cardiac Interventions Registry (IFCIR) was created in 2010 to collect data on fetal interventions from multiple centers (19 centers actively entering data) and improve outcomes. The goal of this study was to look at several technical and procedural aspects of FAV (cannula size, balloon size, number of cardiac punctures) to determine if they were related to procedural and pregnancy outcomes.   Patel et al. report on their analysis of patients from 15 centers in the IFCIR who were candidates for fetal cardiac intervention from 2002-2018. The median center volume was 5 (range 1-21). Patients from Boston Children’s Hospital were excluded as data on those patients had already been presented in the previously mentioned studies. A total of 128 fetuses with a mean gestational age (GA) of 26.1 ± 3.4 weeks were deemed candidates. 108 of these fetuses underwent cardiac puncture and had adequate data in the database to be included for analysis. The indication for FAV was evolving HLHS in 103 fetuses (95.4%). The needle used to puncture the LV was 17 gauge in 15.7%, 18 gauge in 63.9%, and 19 gauge in 29.6%. A single puncture was needed in 77.1%, two punctures in 19.4%, and three punctures in 5.6%. 100 fetuses had an aortic balloon valvuloplasty performed, 90 (83.3%) of which were technically successful (defined as increased forward flow across aortic valve or new aortic regurgitation). The mean aortic valve Z-score was -2.5 ± 1.1 for all fetuses and the median balloon: aortic valve ratio was 1.1. 52 fetuses (48.1%) had at least one intraprocedural complication including bradycardia requiring treatment (37, 34.3%), pericardial effusion requiring treatment (24, 22.2%), pleural effusion (3, 2.8%), balloon rupture (6, 5.6%), and intraprocedural death (9, 8.3%). The overall procedural related mortality was 16.7% (9 intraprocedure deaths, 9 additional deaths within 48 hours). More than one puncture was associated with higher rates of procedural complications (specifically bradycardia, pleural effusion, and intraprocedural death). On multivariate analysis, later GA at intervention and technical success of the procedure were independently associated with live birth.   The outcomes of the pregnancies and infants born is shown below. The 81 fetuses born alive had a median GA of 38.1 weeks, with 26 of them being born prematurely (<37 weeks GA).     This study shows that fetal intervention is often technically successful and offers promise for a biventricular circulation. However, it has significant associated risk with a complication rate of nearly 50% and procedure related mortality of 16.7% (Boston Children’s Hospital’s most recent report had a mortality rate of 6.5%). The higher mortality in this series is multifactorial and likely involves the known learning curve that has been seen in performing this procedure. The authors highlight the importance of center experience and appropriate fetal positioning to minimize the number of punctures. Also, the authors discuss that later GA at the time of the procedure decreased risk likely due to larger fetus size. However, fetuses that were candidates later in gestation may also have less severe disease and waiting for many fetuses could lead to missing the window for prevention of HLHS. Interestingly, of the 81 patients born alive, 22 (27.1%) died prior to hospital discharge. Data from the Single Ventricle Reconstruction trial showed hospital mortality or need for transplantation at 18% (Pasquali SK, Ohye RG, Lu M, Kaltman J, Caldarone CA, Pizarro C, Dunbar-Masterson C, Gaynor JW, Jacobs JP, Kaza AK, Newburger J, Rhodes JF, Scheurer M, Silver E, Sleeper LA, Tabbutt S, Tweddell J, Uzark K, Wells W, Mahle WT, Pearson GD; Pediatric Heart Network Investigators. Variation in perioperative care across centers for infants undergoing the Norwood procedure. J Thorac Cardiovasc Surg. 2012; 144:915–921. doi: 10.1016/j.jtcvs.2012.05.021). While it is unknown if this difference is statistically significant and how many of those patients who died underwent attempted single ventricle palliation, the outcomes of patients that have had a fetal intervention and still require single ventricle palliation versus those that have not warrants further future investigation.    

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Transcatheter Correction of Superior Sinus Venosus Atrial Septal Defects as an Alternative to Surgical Treatment

Transcatheter Correction of Superior Sinus Venosus Atrial Septal Defects as an Alternative to Surgical Treatment Hansen JH, Duong P, Jivanji SGM, Jones M, Kabir S, Butera G, Qureshi SA, Rosenthal E. J Am Coll Cardiol. 2020 Mar 24;75(11):1266-1278. doi: 10.1016/j.jacc.2019.12.070. PMID: 32192652 Similar articles Select item 32214047   Take Home Points: Transcatheter closure of sinus venosus defects is feasible and effective alternative to surgery in adult-sized patients. 3D modeling can help determine candidacy for this transcatheter approach.     Commentary by Dr. Arash Salavitabar (Ann Arbor MI) - section editor of Congenital Heart Disease Interventions Journal Watch: Sinus venosus defects (SVASD) have traditionally been approached surgically. However, transcatheter correction has been a recently evolving and enticing approach which has been reported by several centers over the last few years. The authors of this study report a single-center, early experience with transcatheter SVASD closure using covered stent implantation.   Following the first procedure at this center in March 2016, all patients 16 years of age who were being considered for surgical repair of a SVASD were also considered for transcatheter correction. Suitability of transcatheter closure was assessed in a systematic fashion using both 2D and 3D cross-sectional imaging (either cardiac MRI or CT) and ex vivo simulation of stent implantation on either virtual or printed 3D models. If an anomalous pulmonary vein was noted to be entering the SVC remotely, above the SVC/right atrial junction, and was thought to be too far for surgical redirection of those veins and the anticipated shunt volume was hemodynamically insignificant, this was not deemed a contraindication to this transcatheter approach.     All procedures were performed with TEE guidance. An angiographic catheter was placed in the RUPV for serial venography and pressure monitoring. The approach for RUPV access evolved from a retrograde approach to use of a transseptal puncture with an 8-French SRO Sheath (St. Jude Medical) being placed in the LA to allow simultaneous LA and RUPV monitoring. After a veno-venous “rale” was established between the RIJ and femoral veins, balloon testing of the region of the SVASD was performed, allowing for sizing and “testing” of stent implantation within the intended landing zone with confirmation of shunt elimination by TEE and SVC angiography, while also assessing RUPV patency by TEE, angiography, and pressure gradient.   The stent length was based mainly on pre-procedural imaging data and was selected based on having 2cm of the unexpanded stent in the SVC and 2cm protruding into the RA, below the level of the pulmonary veins. Balloon diameter was selected as 2-3mm larger than the diameter reached on balloon-sizing of the SVC. All patients received a 10-zig covered Cheatham Platinum (CP) stent in 5-8cm lengths, mounted balloon diameters of 18-30mm. Following deployment, flaring of the RA end of the stent was performed with the outer balloon of the balloon-in-balloon catheter and then, if needed, with a Coda balloon (Cook Medical, Bloomington, Indiana). If the RUPV was deemed at risk of compression, an Atlas PTA balloon (Bard Peripheral Vascular, Tempe, Arizona) was inflated within the RUPV to prevent obstruction during stent expansion. All patients were started on clopidogrel 75 mg and aspirin 75 mg for 2 months, followed by aspirin alone for a further 4 months, and those on anticoagulation continued them as monotherapy for at least 6 months.     Following initial stent deployment, additional stents were placed in 13 (52%) of the procedures, 9 of which received a bare CP stent to anchor the covered stent in the SVC. This was performed due to stent migration toward the RA in 5 of those 9 patients. Stent migration was associated with a shorter stent segment apposed to the SVC with a distance from the cranial end to the start of the flared segment of the stent measuring 17 mm (IQR: 12 to 20 mm) versus 21 mm (IQR: 18 to 24 mm) (p = 0.030).   A 2nd covered CP stent was implanted in 4 patients due to residual shunt. There remained a residual shunt in 11 (44%) patients by angiography and 15 (60%) by echocardiography, with only 6 (24%) patients showing a detectable shunt by TTE the following day. RUPV obstruction was suggested by balloon testing in 4 patients and the technique of balloon inflation within the RUPV was utilized to avoid compression during stent deployment and flaring. All patients had unobstructed pulmonary venous return at the end of the procedures.   Major complications included a hemopericardium in 1 patient 3 days after the procedure requiring surgical drainage and found to be related to transseptal puncture, rather than perforation secondary to the stent. Another patient had SVC stent embolization within hours following implantation, requiring surgical removal and repair of the SVASD.   On follow-up of a median 1.4 years (IQR 0.8-1.7 years), cardiac CT in the majority of patients and transcatheter angiography in 1 patient showed a well-positioned SVC stent with unobstructed pulmonary venous return. TTE showed improved RV size in all cases, which was confirmed by MRI in those who had it available at a 1 year follow-up visit. Only 1 patient had a discernible residual shunt by MRI. There were no late complications.   The authors report important information regarding this unique transcatheter approach to treating a lesion that has classically been approached surgically. They showed that with preprocedural planning using virtual and printed 3D models, as well as a collaborative vetting process with a surgical team, this procedure can be performed as a viable alternative to surgery and can be done safely and effectively in this early experience in adult-sized patients. Further studies are surely needed to further investigate its routine use for this indication.    

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Longitudinal Improvements in Radiation Exposure in Cardiac Catheterization for Congenital Heart Disease: A Prospective Multicenter C3PO-QI Study

Longitudinal Improvements in Radiation Exposure in Cardiac Catheterization for Congenital Heart Disease: A Prospective Multicenter C3PO-QI Study.   Quinn BP, Cevallos P, Armstrong A, Balzer D, El-Said H, Foerster S, Glatz AC, Goodman A, Goldstein B, Hainstock M, Janssen D, Kreutzer J, Latson L, Leahy R, Petit C, Shahanavaz S, Trucco S, Whiteside W, Zampi JD, Bergersen L.   Circ Cardiovasc Interv. 2020 May;13(5):e008172. doi: 10.1161/CIRCINTERVENTIONS.119.008172. Epub 2020 May 15.   PMID: 32408819   Take Home Points:   Individual centers can likely achieve radiation reduction via many of the techniques described in this work. Multi-center collaboratives (i.e. PAC3, PC4, etc) are increasingly being recognized as a powerful tool in leading quality improvement efforts by facilitating shared learning between sites and maintaining center engagement.     Commentary from Dr. Konstantin Averin (Edmonton), catheterization section editor of Pediatric Cardiology Journal Watch: Infants and children are at particular risk of developing long-term complications (i.e. cancer) from exposure to ionizing radiation. The ALARA (“As Low As Reasonably Achievable”) principle was first introduced in the 1970s in the nuclear energy sector and was subsequently adopted in the medical field to caution providers to minimize radiation exposure. In the decades since some progress at reducing radiation exposure within congenital interventional cardiology procedures has been made but systematic, multi-center efforts are limited. The authors of this work report on a multi-center effort using rigorous quality improvement (QI) methodology to reduce radiation exposure among participating sites.   Details of the QI methodology, including the key driver diagram can be found in the manuscript. The main key driver domains (see below) were Processes for Improvement; Education for Staff and Physicians; Optimizing Operator Techniques; Optimizing Use of Equipment; and Equipment Manufacturer Discussion.   The primary outcome measure was Dose Area Product indexed to body weight (DAP/kg) with a goal to reduce radiation exposure by 10%. Procedures were broadly categorized into 3 groups based on expected radiation exposure – Radiation Exposure Categories (REC): 1 – low; 2 – medium; 3 – high. A total of 15,257 cases unique cases were entered by 8 sites between January 1, 2015 and December 31, 2017. Overall, there was a 19% decrease in DAP/kg with no change in fluoroscopy time. Most cases were REC 1 (70%) with the greatest decrease in DAP/in this category of cases. There was significant variability in baseline radiation exposures between sites but there were statistically significant reductions in radiation doses in all REC categories at all sites.   The most important drivers of radiation reduction seem to be the sharing of practices and operator techniques through regular webinars, online reporting tools allowing for tracking of progress, identifying center-specific areas for improvement and creation of institution radiation safety committees. Multi-center collaboratives (i.e. PAC3, PC4, etc) are increasingly being recognized as a powerful tool in leading quality improvement efforts by facilitating shared learning between sites and maintaining center engagement.      

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Accessing Femoral Arteries Less than 3 mm in Diameter is Associated with Increased Incidence of Loss of Pulse Following Cardiac Catheterization in Infants

Accessing Femoral Arteries Less than 3 mm in Diameter is Associated with Increased Incidence of Loss of Pulse Following Cardiac Catheterization in Infants Sachin Tadphale 1, Thomas Yohannan 2, Travis Kauffmann 2, Vinod Maller 3, Vijaykumar Agrawal 3, Hannah Lloyd 4, B Rush Waller 2, Shyam Sathanandam 2 Pediatr Cardiol. 2020 Jun;41(5):1058-1066. doi: 10.1007/s00246-020-02357-4. Epub 2020 May 4.   Take Home Points:   Avoiding femoral arterial access in vessels measuring <3mm decreased the incidence of loss of pedal pulse in infants undergoing cardiac catheterization at a single institution Femoral artery diameter <3mm and OD/AD ratio >40% were independent predictors of loss-of-pulse in infants following cardiac catheterization     Commentary from Dr. Arash Salavitabar (Ann Arbor MI), catheterization section editor of Pediatric Cardiology Journal Watch: The authors of this paper had previously reported on a prospective single-center study in which femoral artery (FA) diameter <3mm was an independent predictor for loss of pedal pulse (LOP). As a continuation of that initiative, this study focused on actively avoiding FA access whenever possible if the vessel diameter was <3mm and readdressing the incidence and risk factors associated with LOP in infants undergoing cardiac catheterization.   This paper reported on a 4-year period of elective cardiac catheterizations in patients ≤1 year of age and compared certain factors to the preceding periods that had been reported upon in their previous study. LOP was defined as absence of palpable or Doppler pedal pulses, as confirmed prior to the patient leaving the catheterization lab. Ultrasound evaluations were performed by a trained technician and attending cardiologist, and measurements compared to those performed by an attending radiologist. Ultrasound-guided vascular access was used universally as an institutional policy.   There were 289 patients who underwent catheterization and met criteria during this study period, as compared to 166 patients in the comparison group in the preceding period. Of note, the subject pool in this study included a greater number of patients weighing ≤3kg, with prematurity, and, thus, with smaller FA diameters when compared to prior periods previously reported on by the authors. A significantly lower number of patients had FA access during this period due to the active avoidance of accessing smaller FAs, and in return, the median diameter of FA accessed was significantly larger than in the preceding period [3.2mm (2.7-3.6) vs. 2.9mm (1.6-3.6), p=0.01]. As a result, the incidence of LOP dropped significantly both for the total cohort and for those who had a FA accessed. The ratio of the outer diameter of the catheter sheath to luminal diameter of the artery (OD/AD ratio) decreased as well, from 46.6% (range 32.4-61.3%) to 37.5% (range 30.7-66.0), p<0.01. All other procedural factors did not differ between the two periods.   When combining the subject pools from the two periods, those with LOP had a significant smaller FA diameter at baseline (median 2.4mm, range 1.6-3mm) when compared to those who did not have LOP (median 3.3mm, range 2.4-3.9). Patients with LOP were also of a younger age and smaller size. On multivariate logistic regression analysis of risk factors associated with LOP, FA diameter <3mm (OR 6.48, 95% CI 2.31-11.42, p<0.001) and OD/AD ratio >40% (OR 4.16, 95% CI 1.79-8.65, p<0.001) were independent predictors of LOP.   This policy change implemented at the authors’ institution clearly improved the rate of LOP and identified risk factors for LOP in infants undergoing a cardiac catheterization. It is difficult to determine whether information was potentially missed in the patients who had intentional avoidance of FA access, which was acknowledged as a limitation of the study. Nonetheless, knowing these associations allows for more accurate counseling prior to cardiac catheterization and procedural planning with risks in mind, as it can prevent unnecessary arterial access in patients with small FA diameters, can promote smaller sheath size to meet optimal OD/AD ratio, and can potentially guide anticoagulation thresholds.      

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Routine Surveillance Catheterization is Useful in Guiding Management of Stable Fontan Patients

Routine Surveillance Catheterization is Useful in Guiding Management of Stable Fontan Patients Patel ND, Sullivan PM, Sabati A, Hill A, Maedler-Kron C, Zhou S, Shillingford N, Williams R, Takao C, Badran S. Pediatr Cardiol. 2020 Jan 24. doi: 10.1007/s00246-020-02293-3. [Epub ahead of print] PMID: 31980851   Take Home Points: Routine cardiac catheterization is a common part of Fontan surveillance algorithms. Despite appearing to be clinically stable, a large proportion of Fontan patients in this cohort required transcatheter interventions; required initiation of pulmonary vasodilator therapy; and were identified to have hepatic fibrosis.   Commentary from Dr. Konstantin Averin (Edmonton), catheterization section editor of Pediatric Cardiology Journal Watch: As survival of patients with single ventricle physiology palliated with a Fontan circulation improves it is becoming increasingly recognized that they are prone to developing significant end organ pathology. Various monitoring strategies have been proposed but all usually involve a surveillance catheterization 5-10 years after the Fontan surgery. The value of this assessment has not been fully explored. The authors sought to explore the utility of surveillance cardiac catheterization in stable Fontan patients at a single center.   Sixty-three Fontan patients (mean age 14.6 ± 3.0 and mean time from Fontan surgery 11.3 ± 3.1 years) underwent cardiac catheterization over a 5-year period. The pre-catheterization echocardiograms (within a year) were unremarkable – 80% had normal ventricular function and less than mild AVV insufficiency. Baseline hemodynamics were mostly reassuring with 4 patients having a Fontan pressure > 15 mmHg and 19 having a PVRi > 2.0 iWu. Vasoreactivity testing with iNO was performed in 53 and half had a reduction in the PVRi of at least 20%.   Fifty-seven patients underwent a trans-jugular liver biopsy at the time of procedure with more than half (32/57) demonstrating higher grades of congestive hepatic fibrosis. Forty percent of patients had an intervention at the time of the procedure: pulmonary artery stent (16), existing stent dilation (5), SVC angioplasty (4), Fontan stent (3), and others (7). There were no major complications.   Despite the limitations of this work, the authors demonstrate that routine invasive assessment of Fontan patients can provide valuable information and allow for optimization of the Fontan circulation. Given the high morbidity experienced by this patient population it is important for providers to be pro-active in longitudinal Fontan assessment management as a stable Fontan is not necessarily a good Fontan.    

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Alterra Adaptive Prestent and SAPIEN 3 THV for Congenital Pulmonic Valve Dysfunction: An Early Feasibility Study

Alterra Adaptive Prestent and SAPIEN 3 THV for Congenital Pulmonic Valve Dysfunction: An Early Feasibility Study. Shahanavaz S, Balzer D, Babaliaros V, Kim D, Dimas V, Veeram Reddy SR, Leipsic J, Blanke P, Shirali G, Parthiban A, Gorelick J, Zahn EM.JACC Cardiovasc Interv. 2020 Nov 9;13(21):2510-2524. doi: 10.1016/j.jcin.2020.06.039. Epub 2020 Oct 14.PMID: 33069657   Take Home Points: The Alterra Adaptive Prestent is a self- expanding Nitinol device, partially covered with expanded polytetrafluoroethylene, that serves as a landing zone for implantation of the SAPIEN 3 THV The screening process is comprehensive, including MRI and contrast-enhanced CTA, as well as virtual and physical simulation in patient-specific models. There was 100% successful device and valve implantation at the index catheterization, and no THV dysfunction nor RVOT reinterventions at 6-month follow-up. Commentary from Dr. Arash Salavitabar (Ann Arbor MI, USA), catheterization section editor of Pediatric Cardiology Journal Watch: The authors reports on this early feasibility study designed to determine the safety and functionality of the Alterra Adaptive Prestent in patients with dysfunctional right ventricular outflow tracts (RVOT) or pulmonary valves (PV). The Alterra Adaptive Prestent is a self- expanding Nitinol device, partially covered with expanded polytetrafluoroethylene, in a self-sheathed delivery system. This serves as a landing zone for implantation of the SAPIEN 3 THV. The primary outcome was a 5-item, nonhierarchical composite measure of post-procedural device success and the secondary outcome was a 3-item composite measure of freedom from valve dysfunction at 30 days and 6 months. Patients considered suitable candidates for implantation had proximal and distal landing zone diameters of 27-38 mm and a minimum of 35 mm from contractile tissue to lowest pulmonary artery (PA) takeoff immediately before Alterra Adaptive Prestent insertion. Patients were first evaluated by cMRI and 2D phase contrast MRA, and if met initial criteria for valve implantation, were followed with contrast-enhanced CTA. Perimeter plots of each patient’s RVOT (Figure B), in both systole and diastole, were created and analyzed in relation to the diameter and perimeter of the unconstrained device. Virtual implants were then performed, followed by 3D printed models at peak systole and diastole for each patient (Figures C and D) Over nearly 10 months, 4 investigational sites performed this study on 15 patients, out of 29 patients initially screened, with a median age of 29 years and most common underlying cardiac anatomy of tetralogy of Fallot. Anatomic unsuitability was the primary reason for exclusion. All patients met the composite endpoints of device success. There were no major adverse events through 180 day follow-up, including no deaths, RVOT reintervention, device embolism, endocarditis, or coronary compression. No THV dysfunction nor RVOT reinterventions were reported at 6 months. All patients had trivial-to-mild PR and median RVOT Doppler gradient of 9mmHg. There were several adverse events, including likely TV chordal rupture, self-limited transient ventricular tachycardia, and small pericardial effusion. One patient had an incidental thrombus noted by TTE attached to the inflow of the Alterra Adaptive Prestent and without valve-related thrombus, however the RVOT gradient continued to increase (mildly so) over the following 6 months. Echocardiography showed prominent native valve leaflet tissue that was not entirely captured by the Alterra Prestent, resulting in in-folding of the native leaflet proximal to the Alterra Prestent, causing subvalvular obstruction. Adjustments were made to the pre-procedural imaging to prevent similar episodes from occurring. Another patient had progressive RVOT obstruction secondary to an acute angulation of the RVOT causing the inferomedial aspect of the Alterra Adaptive Prestent to project into the RVOT. This early feasibility study demonstrates the importance of patient-specific pre-procedural imaging and simulation, as well as the thoughtful determination of the interactions between the present and the dynamic, heterogeneous RVOTs in this patient population. The relatively high screening acceptance rate, procedural success rate, and freedom of valve dysfunction at 6-month follow-up make the Alterra Adaptive Prestent a promising and attractive option for patients with dysfunctional RVOTs based on this preliminary experience.

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Long-term outcome of perimembranous VSD closure using the Nit-Occlud® Lê VSD coil system

Long-term outcome of perimembranous VSD closure using the Nit-Occlud® Lê VSD coil system. Kozlik-Feldmann R, Lorber A, Sievert H, Ewert P, Jux C, Müller GC, Dalla Pozza R, Yigitbasi M, Schranz D, Lindinger A, Galal O, Meinertz T. Clin Res Cardiol. 2020 Oct 31. doi: 10.1007/s00392-020-01750-6. Online ahead of print. PMID: 33128576   Take Home Points: In carefully selected patients the Nit-Occlud Le VSD coil may offer an effective option for closure of aneurysmal perimembranous VSDs. There appears to be a low risk of damage to the conduction system but a relatively high risk of other complications (hemolysis, device embolization, and tricuspid valve injury). Commentary from Dr. Konstantin Averin (Edmonton), catheterization section editor of Pediatric Cardiology Journal Watch: Percutaneous closure of ventricular septal defects (VSD) – especially of the perimembranous type (pmVSD) - fell out of favor in the early 2000s due to a relatively high (6%) incidence of complete atrioventricular block. However, with new devices and techniques this approach is slowly regaining favor. The Nit-Occlud Le VSD coil has a reinforced coil configuration with Dacron fibers (Figure 1) and is designed for closure of aneurysmal pmVSDs up to 8mm in diameter. The authors present data from a prospective, multicenter, non-randomized clinical trial of the VSD coil. From October 2006 to June 2011 94 patients with VSDs were screened in 6 tertiary centers in Germany and Israel; 6 were excluded as they had muscular VSDs. The median age was 8 (2-65) years, weight 26.7 (10-109) kg. Device implant was technically successful in 85 (96.6%). The immediate closure rate was 67.2% but increased to 96.4% at 12 month and 98.7% at 5 year follow up. During the procedure there were 5 adverse events (2 device embolizations, 1 episode of severe hemolysis requiring implant of a second device, and arterial access site complications). There were 3 serious adverse events during the follow up period - 2 patients developed hemodynamically significant tricuspid valve regurgitation requiring surgical repair and 1 developed a large vegetation requiring device explant. Minor hemolysis was seen in 8 patients (9.4%) but resolved in all without further intervention. There were no episodes of 2nd or 3rd degree heart block or post-procedure coil embolization. In carefully selected patients the Nit-Occlud Le VSD coil may offer an effective option for closure of aneurysmal perimembranous VSDs. There appears to be a low risk of damage to the conduction system but a relatively high risk of other complications (hemolysis, device embolization, and tricuspid valve injury) which may improve as operator experience with the device grows. The authors acknowledge that they did not meet their enrollment goals due to a change in the legal environment in the course of the study. FIGURE 1 Close-up image of the Nit Occlud® Lê VSD coil. The device configures as larger left-sided cone with reinforced and Dacron fibered distal coil loops and a smaller right-side cone that configures over the left cone.  

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Effect of Clopidogrel and Aspirin vs Aspirin Alone on Migraine Headaches After Transcatheter Atrial Septal Defect Closure: One-Year Results of the CANOA Randomized Clinical Trial

Effect of Clopidogrel and Aspirin vs Aspirin Alone on Migraine Headaches After Transcatheter Atrial Septal Defect Closure: One-Year Results of the CANOA Randomized Clinical Trial View Article Wintzer-Wehekind J, Horlick E, Ibrahim R, Cheema AN, Labinaz M, Nadeem N, Osten M, Côté M, Marsal JR, Rivest D, Marrero A, Houde C, Rodés-Cabau J. JAMA Cardiol. 2020 Sep 23:e204297. doi: 10.1001/jamacardio.2020.4297. Online ahead of print. PMID: 32965476 Take Home Points: New-onset migraines after ASD closure improve or resolve spontaneously within 6 to 12 months in most patients. No significant rebound effect is observed after clopidogrel cessation at 3 months suggesting that early discontinuation should be strongly considered. Commentary from Dr. Konstantin Averin (Edmonton), catheterization section editor of Pediatric Cardiology Journal Watch:  Approximately 15% of patients develop new-onset migraine headaches after transcatheter closure of secundum atrial septal defects (ASD) with nitinol-based devices.  The Clopidogrel for the Prevention of New Onset Migraine Headache Following Transcatheter Closure of Atrial Septal Defects (CANOA) trial demonstrated that these migraines can be successfully treated with clopidogrel within the 3-month period after device implant.  There are limited data on the longer-term outcomes of migraines related to ASD closure.  The authors sought to use the same patient cohort to assess late-incidence and severity of migraine attacks after ASD closure and clopidogrel cessation up to 12 months post-procedure. A total of 171 patients were included for analysis (84 – clopidogrel and 87 – placebo), of which 27 (15.8%) developed migraines in the first 3 months and 2 (1.2%) after the first 3 months (see Figure below).  At 3 months, there were significantly more patients with migraine in the placebo group (21.8% v 9.5%, p = 0.03).  Only 2 patients presented with new migraine headaches after 3 months (none after 6 months) and 6 had residual migraine at 6 months.  Beyond 3 months, there were no significant differences (placebo v clopidogrel) in number of patients with persistent migraine headaches and new migraine headaches after 3 months. The authors conclude that new-onset migraine headaches after ASD closure occurred early (within 3 months) and resolved or improved spontaneously within 6 to 12 months in most patients.  Given the bleeding risks associated with dual antiplatelet therapy (DAPT), especially in older populations, it is important to limit the duration of DAPT.  These data suggest that DAPT can be used successfully for 3 months post-ASD closure in patients who develop migraines.  Future research should focus on identification of patients at risk for developing migraines post-ASD closure and longer term outcomes of persistent migraines.

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Prelimisnary findings on the use of intravascular ultrasound in the assessment of pediatric pulmonary vein stenosis

Prelimisnary findings on the use of intravascular ultrasound in the assessment of pediatric pulmonary vein stenosis View Article Callahan R, Jenkins KJ, Gauthier Z, Gauvreau K, Porras D. Catheter Cardiovasc Interv. 2020 Sep 16. doi: 10.1002/ccd.29264. Online ahead of print. PMID: 32936535 Take Home Points: Intravascular ultrasound (IVUS) was able to be safely performed in patients undergoing catheterization for assessment of pulmonary vein stenosis. IVUS allowed for better characterization of pulmonary vein pathology with moderate inter-observer reproducibility. Commentary from Dr. Konstantin Averin (Edmonton), catheterization section editor of Pediatric Cardiology Journal Watch:  The etiology of pulmonary vein stenosis (PVS) in the pediatric population is heterogeneous and can be challenging to delineate via traditional angiography.  Intravascular ultrasound (IVUS) is additive in the assessment of adult venous pathology.  The use of IVUS in pediatric patients with PVS has not been previously reported.  The authors sought to describe their retrospective single center experience using IVUS in the assessment of pediatric patients with PVS. From August 1, 2016 to December 31, 2019 IVUS was performed in 81 pulmonary veins during 54 catheterizations in 50 patients (median age 1.7 yrs. [0.9-3.1], median weight 8.6 kgs [7.3, 11.8]).  Angiography and IVUS images were reviewed by 2 independent observers and IVUS images were categorized according to the schema below (Figure 1) – initially as adequately or inadequately imaged and then according to the presence of presumed intimal thickening (PIT).  Most pulmonary veins (88%) were adequately imaged, and the inadequately imaged veins were early in the centers experience.  About 50% had PIT, with the obstruction in the remaining veins being related to ostial stenosis or compression/distortion.  The authors provide several nice examples of IVUS imaging of the different pulmonary vein categories (Figure 2).  There was no obvious increase in adverse events during procedures where IVUS was used.  IVUS classifications were moderately reproducible - in patients with existing stents there was 100 inter-rater agreement with regard to presence or absence of in-stent stenosis, while in patients without stents there was somewhat less inter-rater reliability with a combined precent agreement of 75% and a k of 0.67. The authors nicely demonstrate that IVUS can be safely performed in this novel pediatric population.  However, as the authors acknowledge, this paper raises many more questions than it answers.  Further work should focus on whether this imaging modality will allow precise definition of pulmonary vein pathology, assist in tailoring treatment, and improve patient outcomes.  Given the complexity and high morbidity of pediatric PVS stenosis IVUS may play an important role in improving outcomes of this disease. FIGURE 1 Figure 2. Intravascular ultrasound of pulmonary veins contrasted with pulmonary vein pathology specimens (all four examples obtained from different patients); (a) IVUS image of normal pulmonary vein with a thin wall and circular lumen, (b) circumferential specimen of a normal pulmonary vein, (c) IVUS image of vein with presumed intimal thickening and luminal narrowing, (d) circumferential specimen of pulmonary vein with intraluminal pulmonary vein stenosis (neo-intimal proliferation).

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Acute and medium term results of balloon expandable stent placement in the transverse arch-a multicenter pediatric interventional cardiology early career society study

Acute and medium term results of balloon expandable stent placement in the transverse arch-a multicenter pediatric interventional cardiology early career society study View Article Shabana Shahanavaz 1, Osamah Aldoss 2, Kaitlin Carr 2, Brent Gordon 3, Michael D Seckeler 4, Gurumurthy Hiremath 5, Cameron Seaman 6, Jenny Zablah 7, Gareth Morgan 7 Catheter Cardiovasc Interv 2020 Sep 9. doi: 10.1002/ccd.29248. Online ahead of print. Affiliations expand PMID: 32902911; DOI: 10.1002/ccd.29248 Take Home Points: Transcatheter stenting of the transverse aortic arch (TAO) is feasible and with low incidence of major procedural complications. TAO stenting results in significant improvement in aortic arch gradient and narrowest arch diameter. TAO stenting in patients <10kg has an inherently high incidence of reinterventions and should only be used as a temporizing intervention to help achieve growth, recover ventricular function in a single ventricle, or resolution of other comorbidities. TAO stenting may benefit from 3D imaging of aortic arch obstruction to guide interventions. Commentary from Dr. Arash Salavitabar (Ann Arbor, USA), section editor of Congenital Heart Disease Interventions Journal Watch:   The authors addressed an important subgroup of patients, those with transverse aortic arch (TAO) obstruction, that often pose a difficult dilemma regarding whether transcatheter strategies can be utilized. This was a retrospective study from 7 centers from 7/2009 to 12/2017, designed to evaluate immediate and midterm results of TAO stent implantation. TAO stenting was defined as stent placement proximal to the third head and neck vessel with the primary intention of treating narrowing in the transverse aorta. This did not include patients in whom the stent simply traversed the left subclavian artery in the absence of distal arch narrowing. Fifty-seven subjects were included at a median age of 14 years (4 days-42 years). Recoarctation following surgical repair was seen in 79% of patients and previous catheter-based therapy in 11%. The site of maximal narrowing was the isthmus in 35%, proximal transverse arch in 33%, distal transverse arch in 28%, and ascending aorta in 4% of patients. Gothic arches were seen in 25% of patients. 3D rotational angiography was utilized in 35% of cases. Femoral arterial access was used in 90% of cases, femoral venous in 5%, and carotid cutdown in 5% (all <5kg). Stents used were predominantly EV3 LD (Medtronic Inc, Minneapolis) (72%), followed by Palmaz Genesis XD (Cordis Inc Santa Clara Ca) (16%) and premounted [Herculink (Abbott Vascular, Abbott Park, IL) or Valeo (Bard Inc, Tempe, AZ)] (12%). One or more arch branches were jailed by the stent in 55 (96%) patients: left SCA covered in 53 (93%), left common carotid artery in 15 (26%), an aberrant right SCA in 2 (4%) and in 2 (4%) patients with previous subclavian artery flap coarctation repairs there was partial coverage of the left common carotid artery. There were 11 patients (21%) who required balloon angioplasty of the side cells of the stents to maximize patency of vessel origins (7 left common carotid, 3 left subclavian artery). The decisions to perform these interventions were up to the discretion of the interventional cardiologist. There was significant improvement in transcatheter aortic arch gradient (p>0.001), narrowest arch diameter (p<0.001), and systolic BP pressure prior to discharge (p<0.001). There were 7 infants (all <6 months of age) at the time of intervention, 4 of which had recoarctation following a Norwood-type arch reconstruction. All of these patients had premounted stents placed. Surgical re-intervention was performed in 3 (43%) with surgical removal of stents and arch reconstruction. There were 3 (43%) mortalities: 2 with single ventricle physiology, one of which was after next staged surgical palliation and one due to worsening ventricular function, and one with native coarctation and genetic abnormalities. Patients with native coarctation were more likely to have smaller diameters of the ascending aorta, proximal transverse, and distal transverse arch. Patients with native coarctation were more likely to have a higher residual gradient post-intervention (p = .022). Complications included stent migration resulting in unintended jailing of the innominate artery in 2 patients (4%), hypotension warranting inotropic support in 2 patients (4%), pulse loss in 1 patient, and left arm brachial plexus injury in 1 patient. Over the median follow-up of 38 months (0.4-7.3 years), 5 subjects died (all unrelated to the procedure) and there was 1 unplanned and 7 planned reinterventions (6 catheterizations, 2 surgeries). The surgeries were performed in patients in whom initial stenting took place at <1 months of age with the purpose to delay surgery. Antihypertensive medications were used in 27 (47%) patients prior to arch intervention and were continued in 23 (40%) patients at final follow-up. There were no cerebrovascular events or reports of subclavian steal syndrome during follow-up. Of note, there was no routine use of advanced brain imaging before and/or after TAO stenting. The authors concluded that TAO stenting can be useful in select patients within minimal complications. However, systemic hypertension often continues to be an issue and requires medications despite resolution of TAO stenosis. As with all complex congenital lesions, a surgical approach must still be considered and the decision between surgical and transcatheter approaches should be made on an individualized basis.

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Management and Outcomes of Transvenous Pacing Leads in Patients Undergoing Transcatheter Tricuspid Valve Replacement

Management and Outcomes of Transvenous Pacing Leads in Patients Undergoing Transcatheter Tricuspid Valve Replacement View Article Anderson JH, McElhinney DB, Aboulhosn J, Zhang Y, Ribichini F, Eicken A, Whisenant B, Jones T, Kornowski R, Dvir D, Cabalka AK; VIVID Registry JACC Cardiovasc Interv. 2020 Sep 14;13(17):2012-2020. doi: 10.1016/j.jcin.2020.04.054. Epub 2020 Aug 12.PMID: 32800497 Take Home Points: Transcatheter tricuspid valve replacement (TTVR) in the setting of transvenous right ventricular pacemaker leads is feasible and safe. Intra-procedural and long-term attention should be given to transvenous lead dysfunction following intentional lead entrapment by TTVR. There was no significant difference in cumulative incidence of death, TV reintervention, or TV dysfunction on medium-term follow-up of patients with and without pacing leads or entrapped RV leads. Commentary from Dr. Arash Salavitabar (Ann Arbor, USA), section editor of Congenital Heart Disease Interventions Journal Watch:  The authors aimed to answer an important question that often can help decide whether a patient requires transcatheter versus surgical replacement of a tricuspid valve, which is the prevalence of transvenous pacemaker lead complications following transcatheter tricuspid valve replacement (TTVR). This study was performed through the Valve-in-Valve International Database (VIVID) registry and retrospectively analyzed 329 patients who underwent TTVR following surgical TV repair or replacement. Three groups were compared: no lead (n=201), epicardial lead (n=70), and transvenous lead (n=58), with particular focus on those requiring entrapment of transvenous RV leads (see Central Illustration below). Patients who underwent catheterization with intention but without attempt at valve implantation were excluded. The most common type of previous surgical implant was a bioprosthetic valve and most common indication for TTVR was predominantly TR in all 3 groups. Patients with epicardial pacing systems were younger at TTVR (p=0.009), had more prior cardiac surgical procedures (p<0.001), were more likely to have prior bioprosthetic surgical implants (p=0.008), and surgical valve size <29mm (p=0.006). In the 58 patients with a transvenous pacing system who underwent TTVR, the RV lead was entrapped between the TTV and surgical valve/ring in 28. Of the remaining patients, 17 had no RV lead, 10 had a RV lead between the true TV annulus and surgical valve (external to surgical valve), and 3 had the RV lead extracted prior to TTVR. Sapien valves (Edwards Lifesciences) were the predominant transcatheter valve implanted in those with transvenous pacemaker leads. There was a median follow-up period of 15.2 months post-TTVR in these patients. Only 1 patient had a technical modification made related to lead entrapment in order to implant a TTV, which was placement of a covered pre-stent prior to TTVR. Three of 28 patients (10.7%) with intentional RV lead entrapment had complications: lead dislodgment (n=1, TTVR into annuloplasty ring), marked increase in RV lead impedance/stimulation threshold 2 weeks post-TTVR (n=1, TTVR within prior surgical valve), and RV lead fracture 7 months post-TTVR (n=1, TTVR within prior surgical valve). The last of those patients was noted to have early valve failure of the TTV with evidence of thrombus and required surgical valve and RV lead replacement. Procedural outcomes did not differ between patients who did and did not have intentional RV lead entrapment. This study showed that no significant valvular complications were encountered during the peri-procedural or limited follow-up period in this cohort. There was a 7% incidence of RV lead failure in this study at 15.2 months follow-up, which exceeds the rate epicardial lead failure in adults and argues that increased surveillance of these leads is likely warranted after TTVR. The authors admit that longer follow-up will be necessary to determine whether patients who undergo TTVR in the setting of transvenous pacing leads are at risk for accelerated valve dysfunction. However, this study nicely shows that while interventional cardiologists must be aware of the potential complications of transvenous lead dysfunction during and after TTVR, the overall risks of lead and valvular dysfunction are low. While this decision is likely to be individualized until long-term outcomes are better understood, this is a promising option that may be preferable to surgery in many select patients.    

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Munich Comparative Study: Prospective Long-Term Outcome of the Transcatheter Melody Valve Versus Surgical Pulmonary Bioprosthesis With Up to 12 Years of Follow-Up

Munich Comparative Study: Prospective Long-Term Outcome of the Transcatheter Melody Valve Versus Surgical Pulmonary Bioprosthesis With Up to 12 Years of Follow-Up View Article Georgiev S, Ewert P, Eicken A, Hager A, Hörer J, Cleuziou J, Meierhofer C, Tanase D.  Circ Cardiovasc Interv. 2020 Jul;13(7):e008963. doi: 10.1161/CIRCINTERVENTIONS.119.008963.PMID: 32600110 Take Home Points: Percutaneous pulmonary valve implantation (PPVI) with the Melody valve is associated with comparable outcomes to those after surgical pulmonary valve replacement (SPVR). Freedom from infective endocarditis (IE) with or without the need for PV reintervention did not differ between the patients treated with PPVI or SPVR. Of those with Melody valve IE, nearly half could be treated with antibiotics only and had preserved valve function following therapy. Commentary from Dr. Arash Salavitabar, (Ann Arbor MI), catheterization section editor of Pediatric Cardiology Journal Watch:  The authors of this manuscript sought to explore the long-term mortality and morbidity after percutaneous pulmonary valve implantation (PPVI) and surgical pulmonary valve replacement (SPVR) by prospectively comparing the long-term outcomes in patients treated with PPVI with the Melody valve (Medtronic, Dublin, Ireland) and SPVR in a single institution. This prospective, single-center study enrolled patients over 12 years (1/2006-12/2018). This study excluded PPVI performed with other types of transcatheter valves and SPVR performed with pulmonary valves £18mm. A percutaneous approach was used if it was deemed technically feasible by evaluation in the catheterization laboratory, and the remaining patients underwent a surgical approach. This center’s referral pattern to a percutaneous approach initially included the classic dysfunctional RV-PA conduits and bioprosthetic valves, but later included patched right ventricular outflow tracts (RVOTs) as well. Echocardiography was the primary imaging modality for following these patients at regular intervals. Primary end points were death and valve requiring re-implantation of a new pulmonary valve. Patients who reached the end point of valve failure were re-entered in the study as a new case with the new valve. Secondary end points were the presence of endocarditis with or without the need for implantation of a new pulmonary valve. This study included 452 patients, 241 in the Melody group and 211 in the SPVR group. Of the SPVR patients, 136 (65%) had homografts, 57 (27%) Hancocks, 11 (5%) Contegra conduits, and 7 (3%) were comprised of other valve types. Patient age and weight were similar between the PPVI and SPVR groups. The PPVI group had smaller labeled pre-implant valve size (22mm (18-22) vs. 23 (18-32), p >0.001), although this could be considered a clinically insignificant difference in many cases. The PPVI group had a significant higher pre-implant mean RVOT gradient, a smaller number of patients with significant pre-implant pulmonary regurgitation, and a shorter overall follow-up period (4.8 years (0.2-11.6) vs. 6.4 years (0.2-12.6), p <0.001). A total of 18 patents died, with no significant difference between the two groups (7 PPVI [2.9% mortality rate], 11 SPVR [5.2% mortality rate]). Two of the PPVI and 3 of the SPVR patient deaths were early in the post-procedural periods. A combined 42 patients reached valve failure, with 18 PPVI patients and 24 SPVR patients requiring replacement of their valves. There was no statistical difference in freedom from valve replacement between the 2 groups at 10 years (Melody group, 80%; SPVR group, 73%; P=0.46). A total of 24 infective endocarditis (IE) cases were diagnosed (18 PPVI, 6 SPVR). Surgical treatment was required in 10 PPVI and 4 SPVR patients, with the remaining receiving antibiotics with preserved valve function. There were no deaths secondary to IE. The annualized incidence of IE was 1.6% in the Melody group and 0.5% in the SPVR group. The annualized incidence of valve replacement due to IE was 0.9% in the Melody group and 0.3% in the SPVR group. There was no statistical difference in survival free of IE at 10 years (PPVI, 82%; SPVR, 86%; p=0.082), survival free of PVR because of IE (PPVI, 88%; SPVR, 88%; p=0.35). The survival rate free of PVR, no associated with IE, was also not different between the two groups (Melody group, 91%; SPVR group, 75%; p=0.082). The authors admit that their data was limited by the nonrandomized nature of this study. In addition, the Edwards Sapien XT and Sapien 3 valves were not included in this analysis, which are valuable, contemporary additions to the PPVI options in the cardiac catheterization laboratory. However, the prospective design of this study is a valuable addition to the existing data comparing Melody valve PPVI to surgical PVR.

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Outcomes After Transcatheter Reintervention for Dysfunction of a Previously Implanted Transcatheter Pulmonary Valve

Outcomes After Transcatheter Reintervention for Dysfunction of a Previously Implanted Transcatheter Pulmonary Valve View Article Shahanavaz S, Berger F, Jones TK, Kreutzer J, Vincent JA, Eicken A, Bergersen L, Rome JL, Zahn E, Søndergaard L, Cheatham JP, Weng S, Balzer D, McElhinney D. JACC Cardiovasc Interv. 2020 Jul 13;13(13):1529-1540. doi: 10.1016/j.jcin.2020.03.035. PMID: 32646693 Take Home Points: Reintervention (balloon dilation alone or implant of an additional Melody valve) on previously implanted Melody valves is feasible. Implant of a second Melody valve was more durable compared to balloon dilation alone. Commentary from Dr. Konstantin Averin (Edmonton), catheterization section editor of Pediatric Cardiology Journal Watch:  Transcatheter pulmonary valve replacement (TPVR) is an important component in the lifelong management of patients with right ventricular outflow tract (RVOT) obstruction.   The first Melody valve was implanted 20 years ago and has demonstrated a 10-year freedom from reintervention rate of 61%.  Despite this excellent durability many patients will require repeat interventions for recurrent obstruction or regurgitation.  Limited data exist on the outcomes associated with repeat percutaneous intervention in patients with existing Melody valve.  The authors sought to assess technical and procedural factors and outcomes following post-TPVR transcatheter RVOT interventions using pooled data from 3 prospective multicenter Melody valve trials. A total of 309 patients underwent TPVR with the Melody valve from 2007-2013 as part of the 3 early trials included.  Over a median follow up of 5.1 years 46 patients underwent reinterventions, primarily for RVOT obstruction and endocarditis (median age 16 yrs. [7-49], median weight at initial TPVR 61 kgs [27-147]) – 28 had a second Melody implanted (valve in valve [VIV]) and 17 had the original valve dilated.  There were expected reductions in peak RVOT gradient, RV systolic pressure, and RV/aortic pressure ratio in both the VIV and dilation alone groups, but those in the dilation group were not statistically significant.  There were no significant procedural complications. After a median follow up of 3.4 years (Q1-Q3: 1.9 – 5.2) 20 patients underwent a second reintervention and 3 patients had the conduit explanted within 3 months of the initial reintervention which was intended as a temporizing measure in the setting of endocarditis.  Notably, 60% of patients who underwent balloon angioplasty as the initial reintervention required second reintervention.  At 4 years the overall freedom from reintervention was 60% and freedom from explant 83% (see Kaplan Meier curve below). Reassuringly (and not unexpectedly) the authors conclude that VIV Melody implant is an effective and durable treatment for Melody valve dysfunction.  The durability of balloon angioplasty alone may be limited, and strong consideration should be given to bare metal stent with VIV implant.  Combined with recent data suggesting that surgical conduits can be safely dilated to at least 125% of their initial diameter (or larger) even patients with smaller conduits may be able to avoid surgical reoperation via repeat interventions with implantation of larger TPVRs (Melody or others).

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Incidence and fate of device-related left pulmonary artery stenosis and aortic coarctation in small infants undergoing transcatheter patent ductus arteriosus closure.

Incidence and fate of device-related left pulmonary artery stenosis and aortic coarctation in small infants undergoing transcatheter patent ductus arteriosus closure. Tomasulo CE, Gillespie MJ, Munson D, Demkin T, O'Byrne ML, Dori Y, Smith CL, Rome JJ, Glatz AC. Catheter Cardiovasc Interv. 2020 Apr 27. doi: 10.1002/ccd.28942. [Epub ahead of print] PMID: 32339400 Similar articles Select item 32338402     Take Home Points: Transcatheter PDA closure is the preferred treatment option for nearly all patients with PDAs, even those near 1 kg, at most centers LPA stenosis and aortic coarctation are known risk factors in infants undergoing PDA closure This study supports that the majority of LPA and aortic obstruction tend to improve over time Commentary from Dr. Ryan Romans (Kansas City, MO), section editor of Congenital Heart Disease Interventions Journal Watch:   Transcatheter PDA closure (TC-PDA) is at least as safe and as efficacious as surgical ligation and offers a lower morbidity option. It has long been the standard for larger infants, children, and adults. The number of available devices that are able to be delivered through small sheaths has led to improved outcomes in TC-PDA and allowed for closure in smaller infants who were previously routinely referred for surgical PDA ligation. Left pulmonary artery (LPA) stenosis and aortic coarctation are known concerns in this patient population and are well described. However, longer term outcomes of these complications are not known. Tomasulo et al. report on a retrospective analysis of all infants ≤ 4 kg who underwent TC-PDA from 2007-2018. A total of 44 infants met inclusion criteria and had successful TC-PDA. The median weight was 2.8 kg (range 1.2-4 kg), with a trend towards lower weights later in the study time frame (6/10 from 2018 weighed <2 kg). The majority of patients (30/44) underwent PDA closure with an Amplatzer Vascular Plug II (AVP-II), 10 with an Amplatzer Duct Occluder II-Additional sizes (ADOII-AS, now known as the Piccolo device), 3 with an Amplatzer Duct Occluder I (ADO1), and 1 with an Amplatzer Vascular Plug I filled with 3 Cook embolization coils. The devices were placed via an antegrade approach from the femoral vein in all patients. Arterial access was obtained in 59% of patients, though in only 3/17 patients since 2017 (and none who had an ADOII-AS device placed). Type F (61%) and Type C (23%) PDAs made up the large majority of cases. Of the 44 patients, 39 had post procedure echocardiograms performed, all of which showed complete closure of the PDA. Angiography showed mild or less residual shunt in the other 5. Median follow up was 0.7 years (range 2 days-7 years) with 38 patients having assessment for LPA stenosis and aortic coarctation. Of these 38 patients, 21 patients (55%) had obstruction in at least 1 vessel. A total of 17 patients had mild flow acceleration (defined as an echocardiographic flow velocity of 1.5-2 m/sec) or stenosis (flow velocity >2 m/sec) in the LPA (though 3 of these already had flow acceleration/stenosis on their pre procedure echocardiogram). The majority of these improved as shown below. Those who developed LPA obstruction were younger, had larger PDAs, and were less likely to have an AVP II device placed. A total of 4 patients developed flow acceleration in the aorta (flow velocity 1.5-2 m/sec) and 3 developed mild aortic coarctation (flow velocity >2 m/sec). Of these, 4/7 had improved at the time of last follow up as detailed below. Lower birth weight was the only statistically significant factor associated with aortic obstruction, though there was a trend towards later gestational age and shorter PDAs. This study confirms that LPA and aortic obstruction are frequently seen in TC-PDA in small infants. However, the amount of obstruction seen is typically quite mild and likely clinically irrelevant. Additionally, most of the obstruction improves over time and none of the patients in this cohort required additional intervention (though other studies on TC-PDA closure in small infants have shown a small number requiring intervention). While this study adds reassuring information to the literature, the types of devices being used in this population is changing. The Piccolo device now has FDA approval for TC-PDA in this patient population and is now most interventionalists go to device. Additionally, the MVP microvascular plug (Medtronic) has frequently been used for TC-PDA closure in small infants and is not reported on in this study. Future studies are warranted to evaluate these known problems with the devices that are more frequently used today.    

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Here today, gone tomorrow: Outcomes of residual leak following secundum atrial septal defect closure with the GORE CARDIOFORM Septal Occluder.

Here today, gone tomorrow: Outcomes of residual leak following secundum atrial septal defect closure with the GORE CARDIOFORM Septal Occluder. Gordon BM, Abudayyeh I, Goble J, Collado NA, Paolillo J.Catheter Cardiovasc Interv. 2020 Apr 1;95(5):932-936. doi: 10.1002/ccd.28666. Epub 2019 Dec 26.PMID: 31876383 Take Home Points: Residual leaks following device closure of secundum atrial septal defects, particularly when using the GORE CARDIOFORM Septal Occluder, are poorly understood. Patients with larger defects, smaller aortic rims, and with the presence of multiple fenestrations are more likely to have residual leaks following ASD device closure with the GSO. Residual leaks following ASD device closure with the GSO frequently disappear within the first year following implantation. Commentary from Dr. Arash  Salavitabar (Ann Arbor, MI), section editor of Congenital Heart Disease Interventions Journal Watch:  In this retrospective, multicenter study, the authors aimed to review experiences with outcomes of residual leaks following device closure of secundum atrial septal defects (ASD) with the GORE CARDIOFORM Septal Occluder (GSO) during the pivotal and continued access study. This is a well-known potential issue post-device closure of ASDs and the expectant course is not well-described, particularly with this device. One important characteristic of the GSO device is that it is not “self-centering”, and so it has the ability to shift as it conforms to the septal anatomy. This can lead to potential small leaks around the edge of the device. The authors sought to characterize the medium-term outcomes of residual leaks noted with the GSO and to report on potential risk factors associated with eventual closure rates.   This study included 69 patients who had a residual leak following device implantation, out of 374 total patients who underwent ASD closure with the GSO for the pivotal and continued access U.S. trials. Sixty-five (17.5%) patients met inclusion criteria following retrospective review of their echocardiograms. When comparing those with and without residual leak, those with residual leaks had larger defects (10.33 ± 3.05 mm vs. 9.13 ± 2.89 mm, p = .006), larger stop flow balloon sizes (12.91 ± 3.02 mm vs. 11.43 ± 2.89 mm, p < .001), smaller aortic rims (4.87 ± 3.33 mm vs. 6.17 ± 3.78 mm, p = .019), the presence of multiple fenestrations (43.08% vs. 18.69%, p < .001), and increased fluoroscopic time (16.02 ± 9.65 min vs. 13.17 ± 9.03 min, p = .004). Larger devices tended to be implanted and more devices per case were utilized in the residual leak cohort as compared to those without leak. There was no significant differences between procedural time, device- to-defect ratio, or type of anesthesia among groups. Importantly, there was a significant decrease in the leak size over 1 year in those patients with residual leak, from 1.55 ± 0.75mm to 0.25 ± 0.74mm (p < 0.001), with the majority disappearing by that 1 year follow-up (Figure 1). The authors postulate that residual shunts adjacent to ASD closure devices disappear over time due to remodeling of the right atrium with subsequent normalization of right atrial size following removal of the volume load caused by the ASD. This is thought to augment the endothelialization that occurs from adjacent tissue. While this study is limited by its retrospective nature, it provides important information regarding risk factors for residual leak following ASD device closure, particularly with the GSO. It is also valuable to understand that these residual leaks frequently completely disappear over the first year following implantation, which can affect patient counseling, frequency of follow-up, and potential need for future interventions.    

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Here today, gone tomorrow: Outcomes of residual leak following secundum atrial septal defect closure with the GORE CARDIOFORM Septal Occluder

Gordon BM, Abudayyeh I, Goble J, Collado NA, Paolillo J.Catheter Cardiovasc Interv. 2020 Apr 1;95(5):932-936. doi: 10.1002/ccd.28666. Epub 2019 Dec 26.PMID: 31876383 Take Home Points:   Residual leaks following device closure of secundum atrial septal defects, particularly when using the GORE CARDIOFORM Septal Occluder, are poorly understood. Patients with larger defects, smaller aortic rims, and with the presence of multiple fenestrations are more likely to have residual leaks following ASD device closure with the GSO. Residual leaks following ASD device closure with the GSO frequently disappear within the first year following implantation.     Commentary from Dr. Arash  Salavitabar (Ann Arbor, MI), section editor of Congenital Heart Disease Interventions Journal Watch:  In this retrospective, multicenter study, the authors aimed to review experiences with outcomes of residual leaks following device closure of secundum atrial septal defects (ASD) with the GORE CARDIOFORM Septal Occluder (GSO) during the pivotal and continued access study. This is a well-known potential issue post-device closure of ASDs and the expectant course is not well-described, particularly with this device. One important characteristic of the GSO device is that it is not “self-centering”, and so it has the ability to shift as it conforms to the septal anatomy. This can lead to potential small leaks around the edge of the device. The authors sought to characterize the medium-term outcomes of residual leaks noted with the GSO and to report on potential risk factors associated with eventual closure rates.   This study included 69 patients who had a residual leak following device implantation, out of 374 total patients who underwent ASD closure with the GSO for the pivotal and continued access U.S. trials. Sixty-five (17.5%) patients met inclusion criteria following retrospective review of their echocardiograms. When comparing those with and without residual leak, those with residual leaks had larger defects (10.33 ± 3.05 mm vs. 9.13 ± 2.89 mm, p = .006), larger stop flow balloon sizes (12.91 ± 3.02 mm vs. 11.43 ± 2.89 mm, p < .001), smaller aortic rims (4.87 ± 3.33 mm vs. 6.17 ± 3.78 mm, p = .019), the presence of multiple fenestrations (43.08% vs. 18.69%, p < .001), and increased fluoroscopic time (16.02 ± 9.65 min vs. 13.17 ± 9.03 min, p = .004). Larger devices tended to be implanted and more devices per case were utilized in the residual leak cohort as compared to those without leak. There was no significant differences between procedural time, device- to-defect ratio, or type of anesthesia among groups.   Importantly, there was a significant decrease in the leak size over 1 year in those patients with residual leak, from 1.55 ± 0.75mm to 0.25 ± 0.74mm (p < 0.001), with the majority disappearing by that 1 year follow-up (Figure 1).   The authors postulate that residual shunts adjacent to ASD closure devices disappear over time due to remodeling of the right atrium with subsequent normalization of right atrial size following removal of the volume load caused by the ASD. This is thought to augment the endothelialization that occurs from adjacent tissue.   While this study is limited by its retrospective nature, it provides important information regarding risk factors for residual leak following ASD device closure, particularly with the GSO. It is also valuable to understand that these residual leaks frequently completely disappear over the first year following implantation, which can affect patient counseling, frequency of follow-up, and potential need for future interventions.

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Pregnancy Outcomes in Women After Arterial Switch Operation for Transposition of the Great Arteries: Results From ROPAC (Registry of Pregnancy and Cardiac Disease) of the European Society of Cardiology EURObservational Research Programme

Pregnancy Outcomes in Women After Arterial Switch Operation for Transposition of the Great Arteries: Results From ROPAC (Registry of Pregnancy and Cardiac Disease) of the European Society of Cardiology EURObservational Research Programme Tutarel O, Ramlakhan KP, Baris...

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Method comparison of HPLC-ninhydrin-photometry and UHPLC-PITC-tandem mass spectrometry for serum amino acid analyses in patients with complex congenital heart disease and controls

Method comparison of HPLC-ninhydrin-photometry and UHPLC-PITC-tandem mass spectrometry for serum amino acid analyses in patients with complex congenital heart disease and controls Michel M, Salvador C, Wiedemair V, Adam MG, Laser KT, Dubowy KO, Entenmann A, Karall D,...

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