2020

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. 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

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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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...

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Skeletal muscle index determined by bioelectrical impedance analysis is a determinant of exercise capacity and a prognostic predictor in patients with congenital heart disease

Skeletal muscle index determined by bioelectrical impedance analysis is a determinant of exercise capacity and a prognostic predictor in patients with congenital heart disease.   Sato M, Inai K, Asagai S, Harada G, Shimada E, Sugiyama H.J Cardiol. 2020 May...

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