Congenital Heart Interventions

Risk factors associated with device embolisation or malposition during transcatheter closure of patent ductus arteriosus. Mumtaz ZA, Sagar P, Sivakumar K, Mohakud AR, Rajendran M, Pavithran S.Cardiol Young. 2023 Oct;33(10):2041-2048. doi: 10.1017/S1047951122003973. Epub 2022 Dec 14.PMID: 36515000 Take home points: Device embolization occurs in 4% of transcatheter patent ductus arteriosus closures and may lead to significant morbidity. Significant risk factors for device embolization are age ≤ 6 months, large tubular duct, and closure with vascular plugs or undersized devices. rptnb Commentary from Dr. Milan Prsa (Switzerland, Europe), section editor of Congenital Heart Disease Interventions Journal Watch: Transcatheter patent ductus arteriosus (PDA) closure is currently routinely performed across the globe. Device embolization, however, remains a major and occasional complication. The authors of this retrospective study sought to identify risk factors for device embolization and report its intermediate term outcomes. They analyzed data from 376 procedures performed at a tertiary center over an 8-year period. Notably, they used almost exclusively a venous approach and chose the device solely based on an echocardiographic evaluation of the PDA. An undersized device was clearly defined as a conical occluder <2 mm larger than narrowest duct diameter or a vascular plug <150% of the duct diameter. Outcomes were detailed according to the various types of ductal occluders. The results mirror what has been previously reported in the literature. The incidence of embolization was relatively low at 4% but had significant implications for those affected, including the necessity of surgical intervention in 20% of embolization cases. Most embolizations occurred in infants ≤ 6 months (73%), weighing < 6 kg (87%), with tubular ducts (80%) and higher pulmonary artery pressures (93%). The use of vascular plugs and the intentional undersizing of devices to avoid vascular obstruction were also identified as significant risk factors (Table 1). Most devices embolized to the branch pulmonary arteries, including two into distal lobar branches that could not be retrieved and were left in place. The PDA was ultimately successfully closed in 60% of embolization cases. Despite its retrospective design and being limited to a single center's experience, the study provides a meaningful contribution to the existing literature by clarifying risk factors associated with device embolization during transcatheter PDA closure. It offers actionable insights for clinicians to refine their procedural strategies, particularly in high-risk groups, thereby potentially reducing the incidence of these serious complications. The detailed discussion of device types and their specific risks provides a useful guide for device selection in clinical practice. Table 1. Risk factors predisposing to embolization. ParameterP valueOdds ratio95% Confidence Interval for Odds ratioLower  Upper  Morphology of duct Conical Tubular Others    0.003 0.264  Reference 13.9 4.5    2.4 0.3    81.0 64.1Pulmonary arterial hypertension0.069.30.996.5Undersizing of the device0.00124.63.8160Device type Duct occluder Vascular plugs others    0.05 0.6  Reference 4.0 0.4    0.96 0.02    16.8 11.5Body surface area0.20.20.022.6Age group(months) >12 6-12 0-6    0.2 0.002  Reference 4.67 27.7    0.42 3.55    52.3 216.6

Risk Factors and Outcome of Pulmonary Artery Stenting After Bidirectional Cavopulmonary Connection (BDCPC) in Single Ventricle Circulation. Callegari A, Logoteta J, Knirsch W, Cesnjevar R, Dave H, Kretschmar O, Quandt D.Pediatr Cardiol. 2023 Oct;44(7):1495-1505. doi: 10.1007/s00246-023-03229-3. Epub 2023 Jul 15.PMID: 37453932  Take Home Points PA stent implantation early after BDCPC is safe and feasible Single RV, larger neo-ascending aorta, and small LPA at the pre-BDCPC cath are independent risk factors for PA-stent implantation post-BDCPC PA diameters after PA-stent implantation and stent dilation show symmetric growth compared to the contralateral side Commentary from Dr. Jonathon Hagel (C.S. Mott Children’s Hospital, University of Michigan) Branch pulmonary artery (PA) stenosis in the single ventricle population remains a common post operative problem that is often addressed in the cath lab. The authors sought to identify patients at risk of PA-stent implantation after bidirectional cavopulmonary connection (BDCPC) surgery. They secondarily sought to determine if PA growth would be similar in a PA-stented group compared to a group that did not require PA-stent implantation at the time of the pre-TCPC (total cavopulmonary connection) surgery. A single center, retrospective, longitudinal analysis of all patients who underwent single ventricle palliation with pre-BDCPC and pre-TCPC catheterizations were included in this study. From 2006 to 2021, 136 patients met the inclusion criteria of which 56 (41%) were female and single right ventricle (RV) physiology was present in 69 (51%). PA-stent implantation was performed in 40 (29%) patients and of these 37 (92.5%) required LPA stent implantation. LPA compression from the neo-ascending aorta was present in 16/40 (40%) of cases and was the most common etiology necessitating stent implantation. On logistic regression analysis, single RV patients were more likely (OR 0.41, p=0.05) to need PA-stent implantation compared to single LV patients. Smaller LPA diameter (OR 0.89, p=0.03) and larger diameter of the neo-ascending aorta pre-BDCPC (OR 1.05, p=0.001) were associated with an increased likelihood of PA-stent implantation post-BDCPC. Overall, PA diameters were smaller in the PA-stent group but when comparing the pre-BDCPC and pre-TCPC absolute PA diameters among both groups, there was no difference in PA growth. The authors conclude that PA-stent implantation early after the BDCPC surgery is safe and ensures symmetrical pulmonary flow and growth of the hilar intrapulmonary vessels. They further extrapolate that based on their findings, patients at higher risk of needing PA-stent implantation i.e. single RV, smaller LPA at pre-BDCPC cath, and dilated neo-ascending aorta, may be good candidates for exit angiography after the BDCPC surgery. The authors acknowledge that flow differential was not quantitatively assessed by cardiac MRI or lung perfusion scan and such flows may have a greater impact on the growth of PAs. Lastly, as this is a single institution study, frequency and timing of intervention may represent an institutional approach to care making generalizability limited to other surgical or interventional approaches.

Percutaneous Mitral Valve Repair in Pediatric Patients. Haregu F, Wong N, McCulloch M, Lim DS.Pediatr Cardiol. 2023 Dec 27. doi: 10.1007/s00246-023-03387-4. Online ahead of print.PMID: 38150041 Take Home Points:  TEER is feasible in pediatric patients of adequate size with severe MR and high surgical risk. Further studies are needed to understand long-term implications of TEER in the pediatric population. Commentary from Dr. Arash Salavitabar (Ann Arbor, MI, USA), section editor of Congenital Heart Disease Interventions Journal Watch: The authors report on a case series of 4 pediatric patients who underwent transcatheter edge-to-edge repair (TEER) to treat severe mitral regurgitation (MR). The patients were 6-17 years of age and as small as 19 kg, with cardiac diagnoses ranging from heart transplantation following single ventricle palliation, dilated cardiomyopathy and congenital mitral valve dysplasia with degenerative MR. The MitraClip device (Abbott Vascular, Santa Clara, CA) was utilized in all cases. All patients were deemed to be high risk or non-surgical candidates and all cases resulted in a significant improvement in MR. The authors described the MitraClip, which has delivery system that consists of a steerable guide catheter that is 24-French at the skin and 22-French as it crosses the interatrial septum. The large profile was thought to be a likely limitation in its utility in patients under 15-20 kg. The MitraClip device grasps between the anterior and posterior MV leaflets, which brings them together to reduce the regurgitant orifice area. Though there remains a paucity of long-term data on the durability of TEER’s efficacy, particularly when considering younger patients who are surgical candidates, TEER has the potential to reduce heart failure symptoms and degree of MR. Pre-procedural planning is important, with due consideration to patient size and vascular access.

Over-expansion of right ventricle to pulmonary artery conduits during transcatheter pulmonary valve placement. Boucek DM, Qureshi AM, Aggarwal V, Spigel ZA, Johnson J, Gray RG, Martin MH. Cardiol Young. 2023 Nov;33(11):2282-2290. doi: 10.1017/S104795112200405X. Epub 2023 Jan 27.PMID: 36705001 Take Home Points: Right ventricle to pulmonary artery conduits can be dilated beyond 110% of their implant diameter. Procedural complications were more common in the over-dilation group but these were mostly managed in the catheterization lab without significant morbidity and mortality. The ability to over-dilate small diameter conduits can allow patients with right ventricular outflow tract dysfunction to defer or avoid surgical pulmonary valve replacement. Commentary from Dr. Konstantin Averin (Cohen Children’s Heart Center), catheterization section editor of Pediatric Cardiology Journal Watch: Trans-catheter pulmonary valve replacement (TPVR) with the Medtronic Melody valve is now routinely utilized in treatment of right ventricular outflow tract pathology, especially in dysfunctional right ventricular to pulmonary artery conduits.  The original indication for the Melody valve was for conduits with implant diameters of 16mm or greater, excluding many patients with smaller conduits from this therapy.  There has been increasing experience with overdilation of conduits beyond a theoretical guideline of 110% of their implant diameter.  The authors sought to compare outcomes of conduit dilation to >110% of nominal diameter with a control group of ≤ 100%. From November 2010 to March 2017, 172 patients were included in the study – 51 in the overdilation group and 121 in the control group with the overdilation group being younger (11.2 vs 16.7 years, p < 0.001) and smaller (32.8 vs 57.8 kg, p < 0.001) than the controls.  There were more homograft conduits in the overdilation group (73 vs 44%).  The success rate for TPVR was 98% in both groups with the relationship of original conduit size to average final valve diameter in the overdilation group demonstrated in Figure 1.  Amazingly, even conduits <12mm at implant were usually able to be dilated to an average of approximately 20mm.  Procedural complications were more common in the overdilation group (18% vs 7%, p = 0.046).  In the overdilation group complications included 1 uncontained conduit tear requiring ECMO and emergent surgical pulmonary valve replacement; 7 patients had contained tears and 1 had an MPA pseudoaneurysm treated with a vascular plug.  There were no differences in TVPR durability at a mean follow-up of 3.6 years (overdilation) vs 4.1 years (control) – including a combined freedom from reintervention of 89%.  Endocarditis was more common in the overdilation group (16%) compared to the control group (5%) suggesting that a smaller implant conduit diameter (independent of final TPVR diameter or pressure gradient) could be a risk factor for endocarditis. The authors conclude that right ventricle to pulmonary artery conduits can be dilated beyond 110% of their implant diameter.  While complications were more common in the overdilation group these could safely be managed in the catheterization lab without serious morbidity or mortality.  This study continues to add to the literature supporting the overdilation of small conduits to adult diameters, in fact the authors report dilating 9mm conduits to 20+ mm (>200% of implant diameter).  Diseases of the right ventricular outflow tract requiring conduit implant are life-long conditions that will necessitate multiple surgical and catheter-based interventions.  If small conduits can be dilated to large diameters (as suggested by the authors) with relative safety this will allow providers to minimize the number of lifetime surgical interventions.  Figure 1.

Safety and Short-Term Outcomes for Infants < 2.5 kg Undergoing PDA Device Closure: A C3PO Registry Study. Barry OM, Gudausky TM, Balzer DT, Bocks ML, Boe BA, Callahan R, El-Said H, Farias MJ, Foerster S, Goldstein BH, Holzer RJ, Janssen D, Levy P, O'Byrne ML, Rahman G, Sathanandam S, Shahanavaz S, Whiteside W, Turner ME.Pediatr Cardiol. 2023 Aug;44(6):1406-1413. doi: 10.1007/s00246-023-03147-4. Epub 2023 Mar 30.PMID: 36995404 Commentary from Dr. Milan Prsa (Switzerland, Europe), section editor of Congenital Heart Disease Interventions Journal Watch: Take home points: Transcatheter PDA closure can be effectively and safely performed in infants <2.5 kg, even in low-volume centers. Adverse events are associated with the presence of non-cardiac problems and the use of multiple devices during the procedure. Despite ongoing controversy as to the indications and timing of the procedure, transcatheter closure of a hemodynamically significant patent ductus arteriosus (PDA) in premature infants is being increasingly performed across centers. The authors present findings from the largest multi-center retrospective review of PDA device closure in infants weighing less than 2.5 kg using data from the Congenital Cardiac Catheterization Project on Outcomes (C3PO) registry. Data were collected from April 2019 to December 2020 across 13 participating centers. A total of 300 cases were analyzed with an emphasis on procedural success, defined as effective device placement at the conclusion of the catheterization, and the occurrence of adverse events (AEs). Characteristics associated with outcomes were additionally explored. The results show a remarkable procedural success rate of 98.7% (on the first attempt in 92% of cases), predominantly with the Amplatzer Piccolo Occluder, used in 78% of cases. The incidence of moderate severity (level 3) AEs was 5.6%, including 4 device embolizations, and there were five cases (1.7%) with major/catastrophic (level 4/5) AEs, including one patient who died 12 h after the procedure due to post ligation syndrome and urosepsis (Table 1). There was no significant association between procedural success or AEs and factors such as patient age, weight, or institutional volume. However, a higher risk of AEs was associated with patients who had non-cardiac problems and procedures where multiple devices were attempted. This study showcases the high success rate of PDA device closure in very small infants across various institutions, paving the way for more widespread adoption of this procedure. It highlights the importance of careful patient and device selection to minimize the risk of serious adverse events in this vulnerable population. Long-term follow-up is necessary to fully understand the implications of early PDA device closure. Table 1. Adverse events by severity level Adverse eventsn (% of total cases)Level 3 (moderate) adverse events17 (5.6) Device embolization4 (1.3) Depressed cardiac output2 (0.7) Systemic arterial thrombosis2 (0.7) Atrial arrhythmia1 (0.3) Hypotension1 (0.3) Hypoxia1 (0.3) Medication error1 (0.3) Post-extubation stridor1 (0.3) Respiratory distress1 (0.3) Sinus tachycardia1 (0.3) Tricuspid regurgitation1 (0.3) Vessel trauma1 (0.3)Level 4/5 (major/catastrophic) adverse events5 (1.7) Device malposition2 (0.7) Respiratory arrest2 (0.7) Death1 (0.3) *Two cases had two level 3/4/5 events each

3-year follow-up of a prospective, multicenter study of the Amplatzer Piccolo™ Occluder for transcatheter patent ductus arteriosus closure in children ≥ 700 grams. Morray BH, Sathanandam SK, Forbes T, Gillespie M, Berman D, Armstrong AK, Shahanavaz S, Jones T, Rockefeller T, Justino H, Nykanen D, Weiler C, Gutfinger D, Zahn EM.J Perinatol. 2023 Oct;43(10):1238-1244. doi: 10.1038/s41372-023-01741-1. Epub 2023 Aug 16.PMID: 37587183  Take Home Points Overall survival at 3-year follow-up for the entire cohort was 95.3% and for patients ≤2 Kg at the time of implant was 92.9%. 9 patients died following device placement but causes of death were reviewed independently by the clinical events committee and no deaths were adjudicated as device or procedure related. Beyond 6 months there were no additional device or procedure replated complications. An increase in tricuspid regurgitation (TR) was reported in 5 patients but none required intervention to repair or replace the tricuspid valve at 3-year follow-up. Echocardiography follow-up demonstrated effective patent ductus arteriosus (PDA) closure achieved in 97.4% of patients at 30 days post implant, 99.4% at 6 months and 100% through 3-years. Commentary from Dr. Jonathon Hagel (C.S. Mott Children’s Hospital, University of Michigan)             Transcatheter patent ductus arteriosus (PDA) closure is the mainstay of therapy in older children and adults though controversy has persisted about the optimal approach to PDA closure in preterm infants. The Amplatzer Piccolo Occluder (Abbott Structural Heart, Plymouth, MN) was approved for commercial use in the United States by the Food and Drug Administration in 2019 for PDA closure in patients ≥700. Patients began enrollment in June 2017 for the prospective single arm multicenter pre-marked study to characterize the safety and effectiveness of the Amplatzer Piccolo Occluder in children ≥700g and ≥3 days of age at the time of implant. The procedural outcomes and 6-month clinical data were previously published. This study reports the 3-year clinical outcomes in this cohort of patients.             A total of 200 patients were enrolled in the study and the entire cohort was split evenly by weight ≤2 Kg (n=100) and ≥2 Kg (n=100). The mean weight of infants referred from the NICU was 0.85 +/- 0.29 Kg and had a mean gestational age of 26 +/- 3 weeks. There were 9 unsuccessful implants, 5 patient deaths prior to 6-month follow up and an additional 4 patient deaths after six months leaving 182 patients available for analysis at 3-year follow up.             Overall patient survival at 3 years was 95.3% and for children ≤2 Kg was 92.9%. Beyond 6-months there were no additional device or procedure related adverse events. All patient deaths were independently reviewed by the clinical events committee and found to be unrelated to the procedure or device. Only 33 echocardiograms were available at 3-year follow-up but all (33/33) demonstrated complete PDA closure with no residual defect. There was no late cases of aortic obstruction and no cases of LPA obstruction requiring intervention at 3-year follow up. An increase in TR was reported in 5 patients with four available for analysis at 3-year follow up and none required intervention or repair of the tricuspid valve.              The authors conclude that transcatheter PDA closure with the Amplatzer Piccolo Occluder is safe and effective and with 3-year follow up there is 100% successful closure and >95% survival.  They concede, however, that although a high rate of technical success and low rates of complications are achieved, the impact on the clinical course of patients treated with this device requires ongoing investigation.  

Safety and utility of CardioMEMS device for remote pulmonary artery monitoring in pediatric Fontan patients: a case series. Bhat DP, Graziano JN, Garn BJ, Franklin WJ.Eur Heart J Case Rep. 2023 Aug 30;7(9):ytad422. doi: 10.1093/ehjcr/ytad422. eCollection 2023 Sep. PMID: 37705945 Commentary from Dr. Thomas Zellers (Dallas, USA), section editor of Congenital Heart Disease Interventions and ACHD Journal Watch: Take home points: Fontan pressures may change with activity, elevation, and cardiac function CardioMEMS is a tool that can be used for pulmonary artery pressure monitoring at home CardioMEMS can be easily and safely implanted in Fontan patients using transcatheter methods Summary: This a single center, retrospective case report of the use of the CardioMEMS device, between 09/2021 and 04/2023, in eight selective patients post Fontan procedure with Fontan associated liver disease (FALD) or protein losing enteropathy (PLE) and whose pulmonary artery pressures were in question and underwent cardiac catheterization under anesthesia. All had device placement at the time of cardia catheterization to monitor changes in PA pressures. All these patients had PA pressures that measured lower than expected given their associated organ dysfunction. The authors present all 8 patients highlighting 2 patients who had significant increases (up to 18-20 mmHg) in their PA pressures noted by the CardioMEMS device which allowed the primary cardiologists to alter their medical therapy. The authors felt that their two cases specifically illustrate that pulmonary artery pressures can be underestimated in these patients with FALD and PLE who have catheterization under anesthesia. They emphasize that the CardioMEMS can be implanted safely and provides important follow-up hemodynamic information in this subset of Fontan patient, and potentially improves the medical management in selective situations. Tables: Table 1

Outcomes and Risk Factors of Interventions for Pediatric Post-operative Pulmonary Vein Stenosis. Fujita KT, DiLorenzo MP, Krishnan US, Turner ME, Barry OM, Torres AJ, Bacha EA, Kalfa D, Crystal MA. Pediatr Cardiol. 2023 Dec;44(8):1778-1787. doi: 10.1007/s00246-023-03214-w. Epub 2023 Jul 9. PMID: 37422845 Take Home Points: Outcomes for pediatric patients with pulmonary vein stenosis remain guarded with a possible survival advantage if an aggressive treatment strategy is undertaken. In patients with recurrent post-operative PVS mortality is associated with complex congenital heart disease, single ventricle heart disease and genetic disorders. Commentary from Dr. Konstantin Averin (Cohen Children’s Heart Center), catheterization section editor of Pediatric Cardiology Journal Watch: Pulmonary vein stenosis (PVS) in pediatric patients with congenital heart disease is a complex disease that carries a high degree of morbidity and mortality.  Surgery for PVS is often preferred as the baseline intervention for PVS as it may be associated with greater freedom from reintervention and death compared to a baseline trans-catheter approach.  Outcomes for treatment of recurrent PVS after baseline surgical repair have not been assessed.  The authors sought to evaluate outcomes and identify risk factors associated with patient mortality and vein atresia in post-operative PVS patients in a single center. From January 2005 to July 2020, 305 patients underwent baseline surgical repair with 46 (15%) requiring reintervention for PVS and comprising the primary study cohort (Figure 1). The median age at baseline surgery of the study cohort was 18.9 days (0-42.8 months) and the time from baseline surgery to the first (index) procedure for recurrence was 4.4 months (0.7-79.5 mon).   The total number of procedures varied, but 3 patients required 6 and transcatheter approaches were more commonly chosen for patients who require more interventions.  Overall, 11 (23.9%) patients died at a median 1.6 months (1 day-9.7 years) after the index procedure (first procedure for recurrent PVS) with presence of a genetic disorder, single ventricle physiology and complex congenital heart disease being associated with mortality.  Half of the cohort developed pulmonary vein atresia of at least one vein and interestingly all patients who had necrotizing enterocolitis developed atresia. This small, descriptive study continues to add to the literature surrounding treatment and outcomes of pediatric patients with PVS.  Many providers hypothesize that aggressive treatment of recurrent PVS with frequent, repeat interventions may confer a survival advantage and while this study found that repeat interventions were associated with improved survival this may represent survival bias as death occurred relatively soon after the index procedure.  Some interesting associations were also reported (i.e. necrotizing enterocolitis and male gender with pulmonary vein atresia) but this will need to be explored in future studies with larger patient volumes.  Figure 1. Figure 2.

Transcatheter closure of ventricular septal defects: preliminary results in children weighing 10 kg or less. Mirza M K, Abqari S, Haseen A, Yadav M.Cardiol Young. 2023 Apr;33(4):539-545. doi: 10.1017/S1047951122001147. Epub 2022 May 2.PMID: 35491695 Take Home Points:  Device closure of perimembranous ventricular septal defects is feasible in patients ≤ 10 kg in weight. Careful attention must be given to aortic and tricuspid valve interactions using intraprocedural TEE guidance. Although a retrograde approach was preferred amongst the authors, flexibility regarding approach is needed to limit complications. Commentary from Dr. Arash Salavitabar (Ann Arbor, MI, USA), section editor of Congenital Heart Disease Interventions Journal Watch: The authors of this retrospective single-center study aimed to evaluate the efficacy and safety of transfemoral device closure of perimembranous ventricular septal defects (VSDs) in patients ≤ 10 kg in weight. The authors approached this procedure with initial left ventricular angiography and chose the device based on the presence of a ventricular septal aneurysm, length of subaortic rim, and VSD diameter. The VSD device was chosen to be 1-2mm greater than the largest measurement of VSD color flow by TEE. Over a 7-year period, 16 patients underwent this procedure at a median age of 11 months (IQR 9-15.5) and median weight 8.3 kg (7.2-9.5). The median defect size by TEE was 6.8mm (6-8.5) and median VSD device diameters were 6.2 mm (5.7-8.3). The following devices were use: Amplatzer Duct Occluder II (n=6); Lifetech Symmetric Membranous VSD Occluder (n=4), KONAR-MF VSD Occluder (n=4), Lifetech Eccentric Membranous VSD Occluder (n=1), and Occlutech PmVSD Occluder (n=1). A retrograde deployment was preferred (14/18 total device implantation attempts). The only comment regarding choice of device was regarding the tendency to use symmetric double-disc occluders in all but one patient. The procedural success rate was 88% (n=14). Of the two unsuccessful device placements, one involved development of moderate aortic regurgitation via retrograde approach and moderate TR via antegrade approach. The other unsuccessful case was a patient who developed progressive, moderate AR over 2 days post-procedure. Each of these patients required surgery. There were no device embolizations. On median follow-up of 40.5 months (25-64), none developed complete heart block. This paper nicely showed that this procedure can be performed safely in small patients with perimembranous VSDs, with careful consideration to VSD anatomy, aortic valve rim, and interactions with aortic valve and tricuspid valve apparatus. Importantly, the majority of the devices used by the authors are not available in the United States, which emphasizes the importance of formal investigation and future FDA approval of additional device options for this indication. Similar studies are needed to understand the details of ventricular septal anatomy, optimal device choice, and patient selection.

Pre-Fontan Assessment Utilizing Combined Cardiac Catheterization and Cardiac MRI: Comparison to the Pre-Fontan Catheterization. Eilers LF, Britt JJ, Weigand J, Penny DJ, Gowda ST, Qureshi AM, Stapleton GE, Khan A, Webb MK, Bansal M.Pediatr Cardiol. 2023 May 21. doi: 10.1007/s00246-023-03178-x. Online ahead of print. PMID: 37210685 Take Home Points: Cardiac magnetic resonance imaging (CMR) allows for a comprehensive assessment of ventricular function, aortopulmonary collateral burden, and lymphatic abnormalities. Combined CMR and cardiac catheterization led to a decrease in catheterization duration, amount of contrast received, and fluoroscopy time. CMR performed prior to the catheterization allowed for more targeted aortopulmonary collateral occlusion without a change in short term post-operative outcomes. Commentary from Dr. Ryan Romans (Kansas City, MO), section editor of Congenital Heart Disease Interventions Journal Watch: Patients with single ventricle congenital heart disease undergo staged palliation to separate the systemic and pulmonary circulations. The final stage is an inferior cavopulmonary anastosis, or Fontan procedure. Survival through stage palliation has improved in the modern era, though there is still significant morbidity (including systemic ventricular dysfunction, protein losing enteropathy, plastic bronchitis, liver and kidney dysfunction, lymphatic dysfunction). This morbidity highlights the need to ensure appropriate patient selection for Fontan completion versus consideration for hear transplant evaluation. Typical evaluation prior to Fontan has included echocardiography and cardiac catheterization.  However, cardiac magnetic resonance (CMR) offers the ability to define anatomy, provide a more thorough assessment of ventricular function, better quantify AV valve regurgitation, quantitatively assess aortopulmonary (AP) collateral burden, and define lymphatic abnormalities prior to Fontan. The authors hypothesized that combined CMR and cardiac catheterization could offer a thorough hemodynamic and anatomic assessment and allow for targeted intervention. A single center, retrospective cohort study was performed on all patients who underwent combined pre-Fontan CMR and cardiac catheterization from 10/2018-4/2022.  These were then matched randomly by month of procedure to patients who underwent pre-Fontan catheterization only. A total of 37 combined patients and 40 cardiac catheterization only patients were included in the analysis. In the combined group, all patients were placed under general anesthesia and underwent the CMR prior to cardiac catheterization. The CMR protocol included cine SSFP function, cine SSFP anatomy, 3D MRA with gadolinium, and phase-contrast encoded velocity mapping of flows. In the combined group, an angiogram was routinely performed in the SVC with an aortagram performed at the discretion of the interventional cardiologist. Those who underwent a catheterization only also had angiograms performed in the IVC, descending aorta, and pulmonary vein(s). Patients in the combined group had a longer duration of intubation (293 minutes, SD 51 minutes versus 193 minutes, SD 73 minutes) and anesthesia time (320 minutes, IQR 290-352 minutes versus 200 minutes, IQR 165-255 minutes). Time in the catheterization lab, procedure time (start of access to sheath removal), contrast dose per kilogram, and fluoroscopy time were all lower in the combined group. Radiation dose was also lower in the combined group, though this was not statistically significant. Patients who underwent a cardiac catheterization only were more likely to have an intervention performed (48% versus 19%) with the majority of these being aortopulmonary collateral occlusion. Fontan completion, cardiopulmonary bypass time, ICU length of stay, and post operative chest tube duration was not significantly different between groups. CMR offers significant benefits as part of the pre-Fontan cardiac evaluation. In addition to evaluating systemic ventricular function more thoroughly than echocardiography, CMR also provides an objective assessment of AV valve regurgitation (via regurgitant fraction), can evaluate the lymphatic system, and allows quantification of aortopulmonary collateral burden. This study showed that CMR performed as part of the pre-Fontan cardiac catheterization can reduce case duration, iodinated contrast volume, and radiation exposure. Additionally, pre catheterization CMR allowed for more targeted interventions (especially aortopulmonary collateral occlusion) with objective data (elevated end diastolic pressure or 30% or greater collateral flow) determining intervention instead of the discretion of the interventional cardiologist. Using these guidelines, the authors showed that post-operative outcomes were similar between the groups.

Authors: Luxford JC, Adams PE, Roberts PA, Mervis J. Journal: Heart Lung and Circulation 2023 32, 638-644. Doi.org 10.1016 Take home points: Retrospective review of 20 patient (all < 3 months of age) from Sydney, Australia with primary RVOT stenting Average improvement with mean saturation increased from 80% to 91%. 18 survived (2 non cardiac deaths) with 12 requiring re intervention on the RVOT stent prior to open heart repair. All 18 achieved definitive repair at ~ 6 months of age. The need for more than one RVOT stent was associated with longer bypass and cross clamp. Commentary from Dr. Thomas Zellers (Dallas, USA), section editor of Congenital Heart Disease Interventions and ACHD Journal Watch: This is a retrospective study evaluating all patients undergoing RVOT stenting between January 2010 and December 2020. Only patients with native RVOT stenosis were included; no rescue, secondary implants or conduit implants were included in the analysis. The study was approved by the hospital Ethics Committee and statistics were summarized using standard statistical analysis on SPSS and GraphPad Prism software with a significant P value of < 0.05. Catheterization technique involve the use of a 4Fr or 5Fr right coronary catheter, a coronary wire and delivery without a long sheath in the RVOT. The group switched from bare metal to covered stents during the study evaluation because it reduced intimal proliferation. Aspirin 5 mg/kg/day dosing was recommended if there was no contraindication. Follow up was continued to their surgery and until their last follow up unless they died prior to surgery. The population included 12 with hypercyanotic spells and 8 who were PDA dependent and on prostaglandin. The majority were neonates and 8 were less than 2.5 kg, 18 were urgent procedures and 12 had a major co-morbidity or genetic syndrome. There was one major complication with need for isoprenaline for heart block, which resolved with time.The stents were enlarged to an average of 5-6 mm and 18 of 20 survived (No cardiac deaths). Thirteen required reintervention prior to definitive repair. Only one required reintervention within a week of the original procedure. Pulmonary artery growth increased with time to nearly z scores < -1 or greater in the majority. Tables: Conclusions: RVOT stenting became the standard of care at this hospital with excellent results (better than standard BT shunts in their population) and could be performed in small neonates safely. The majority transitioned to covered stents which reduced intimal hyperplasia but did not change the time to definitive repair or reintervention. The pulmonary artery growth was normal but more than one RVOT stent increased the cross clamp and bypass time.

Pre-Glenn aorto-pulmonary collaterals in single-ventricle patients. Sharma VJ, Carlson L, Esch J, Gopal M, Gauvreau K, Wamala I, Muter A, Porras D, Nathan M.Cardiol Young. 2023 Dec;33(12):2589-2596. doi: 10.1017/S1047951123000665. Epub 2023 Apr 17.PMID: 37066762 Take Home Points Male sex, age at pre-bidirectional Glenn catheterization and increased Qp:Qs are associated with a moderate to severe AP collateral burden. AP collateral burden is not associated with death, transplantation, or the incidence of pulmonary artery interventions. Of the patients who need an intervention for AP collaterals, more than half need only a single intervention. Commentary from Dr. Jonathon Hagel (C.S. Mott Children’s Hospital, University of Michigan), section editor of Congenital Heart Disease Interventions Journal Watch: Aorto-pulmonary (AP) collaterals are commonly found in single ventricle patients due to presumed hypoxia-induced vascular endothelial growth factor activity. The authors sought to describe the risk factors for developing AP collaterals following the Norwood procedure. They secondarily sought to determine in AP collateral burden has an impact on death, transplantation, or pulmonary artery interventions. From January 2011 until March 2016, 104 patients underwent the Norwood procedure for various forms of single ventricle heart disease, the most common of which was hypoplastic left heart syndrome (77.9%) with Sano shunt modifications in most cases (78.8%). 84 patients underwent both a pre-bidirectional Glenn catheterization and subsequent bidirectional Glenn procedure and thus were included in the analysis. AP collateral interventions were performed during the pre-bidirectional Glenn catheterization in 54.8% of cases. AP collateral interventions were performed after the bidirectional Glenn procedure in 82% of cases and of the cases that underwent intervention for AP collaterals, 45.2% underwent a single procedure to target the collaterals. On multivariable analysis, male sex (OR 3.36; 95% CI 1.17-11.4), age at pre-bidirectional Glenn assessment (OR 2.12; 95% CI 1.33-3.39 per month increase) and Qp:Qs ratio (OR 1.23; 95% CI 1.08-1.41 per 0.1 unit increase) were significantly associated with moderate to severe AP collateral burden. AP collateral burden diagnosed at the time of pre-bidirectional Glenn catheterization was not associated with death or transplantation (HR 1.19; 95% CI 0.37-2.61). The incidence of pulmonary artery intervention did not vary significantly based on severity of AP collateral burden. The authors conclude that AP collateral burden after the Norwood procedure is common and that Qp:Qs, male sex, and age of the pre-bidirectional Glenn catheterization are strong markers of AP collateral burden but the presence of AP collaterals does not confer an increased risk of death, transplantation, or pulmonary artery intervention. Due to the lack of well-established guidelines for the diagnosis or management of AP collaterals, the frequency and timing of intervention more represent an institutional approach rather than a clinical indication for intervention which makes inference on association with long term outcomes difficult though at least in this single center study, severity of AP collateral burden was not associated with adverse long-term outcomes.

Predictors of Serious Adverse Events and High-Level Cardiorespiratory Support in Patients Undergoing Transcatheter Pulmonary Vein Interventions. Barreto JA, Gauvreau K, Porras D, Esch JJ, Maschietto N, Quinn B, Bergersen L, Stein M, Callahan R.Pediatr Cardiol. 2023 Apr;44(4):806-815. doi: 10.1007/s00246-023-03129-6. Epub 2023 Mar 3.PMID: 36869157 Take Home Points Adverse events related to transcatheter pulmonary vein (PV) interventions are common with an incidence of ~25% though major/catastrophic adverse events (i.e. death, ecmo, stroke) are rare (1.8%). There is no association between higher number of PVs or the number of balloon/stent angioplasties and serious adverse events or high-level cardio-respiratory support following catheterization. Younger patients and those with abnormal hemodynamics secondary to PVS are more likely to have a serious adverse event or require high-level cardiorespiratory support following catheterization. Commentary from Dr. Jonathon Hagel (C.S. Mott Children’s Hospital, University of Michigan), section editor of Congenital Heart Disease Interventions Journal Watch: Transcatheter pulmonary vein (PV) interventions are the mainstay in therapy for patients with recurrent pulmonary vein stenosis (PVS). The authors sought to describe the frequency and predictors of serious adverse events (AEs) in patients undergoing transcatheter PV interventions through a retrospective review of a large cohort of patients at a quaternary care facility with a well-established PVS program. They also aimed to determine risk factors associated with high-level cardio-respiratory support following transcatheter PV intervention. From March 1, 2014 to December 31, 2021, 240 patients with a total of 841 catheterizations involving PV interventions were included in this study. The median age at intervention was 12 months (IQR 9-26). A majority (84%) had PVS related to congenital heart disease, of which anomalous pulmonary venous return was the most common diagnosis (41%). More than half (57%) of cases involved five or more balloon dilations or stents. At least one AE was reported in 208 (25%) of cases with one serious AE in 100 cases (12%) major AE in 14 cases (1.7%) and catastrophic AE in 1 case. Age less than 6 months, weight less than 5 Kg, low systemic arterial saturation, severely elevated mean PA pressure and pre-catheterization hospital admission were associate with a higher odds of serious AEs. There was no association between number of PVs undergoing intervention or number of balloon/stent angioplasties and serious AEs or high-level cardiorespiratory support following catheterization. Hospitalization prior to catheterization, patients younger than one year at time of catheterization and moderate-severe RV dysfunction were more likely to require high-level cardiorespiratory support following catheterization. The authors conclude that given the lack of association between multiple interventions on a high number of PVs and adverse outcomes or high-level cardiorespiratory support, it is safe to plan such cases. Adverse events and high-level cardiorespiratory support are more likely in younger patients and those with abnormal hemodynamics secondary to PVS and therefore appropriate case planning for recovery and post-catheterization disposition should be made.  

Percutaneous approach to residual pulmonary bifurcation stenosis in conotruncal diseases.Castaldi B, Di Candia A, Cuppini E, Sirico D, Reffo E, Padalino M, Vida V, Di Salvo G.Cardiol Young. 2024 Jan;34(1):24-31. doi: 10.1017/S1047951123000999. Epub 2023 May 4.PMID: 37138545 Take home points: Percutaneous treatment of pulmonary bifurcation stenoses with kissing balloon inflation using high-pressure balloons is effective in most cases. Stenting of the pulmonary bifurcation is required when there is a concomitant indication for pulmonary valve implantation. Commentary from Dr. Milan Prsa (Switzerland, Europe), section editor of Congenital Heart Disease Interventions Journal Watch: Pulmonary bifurcation stenoses (PBS) are a relatively common problem after repair of conotruncal defects (CTDs). As surgical angioplasty is often inadequate due to residual stenosis, percutaneous treatment is usually preferred. However, successful ballooning and/or stenting of PBS can be very challenging and long-term results are scantly reported. In this retrospective study, the authors analyse the mid-term outcomes of different interventional strategies to treat obstructions involving the distal main pulmonary artery and/or the origin of pulmonary artery branches. Between January 2014 and December 2021, 39 patients (age 8.7 ± 7.8 years, weight 31.0 ± 26.3 kg) with repaired CTDs (22 with tetralogy of Fallot, 8 with truncus arteriosus, and 9 with d-transposition of the great arteries) underwent percutaneous treatment of hemodynamically significant PBS at the Padua University Hospital. Types of interventions included single high-pressure balloon inflation (SB), kissing balloon inflation (KB), standard stent implantation techniques without jailing of a branch pulmonary artery (SS) and more complex stent implantation techniques involving provisional jailing of a branch pulmonary artery (JS). Procedure success, defined as a residual invasive pressure gradient across the pulmonary bifurcation of <20 mmHg, was 15% (5/33) for SB, 60% (6/10) for SS, 82% (14/17) for KB and 100% (10/10) for JS. The treatment and outcome flowchart is presented in Figure 1. Eight patients undergoing JS also had transcatheter pulmonary valve replacement (TPVR). Complications included inadvertent jailing of a pulmonary artery in 2 patients undergoing SS and hemothorax from guidewire injury, requiring percutaneous drainage and blood transfusion, in 1 patient undergoing JS. At a mean follow-up of 20 ± 15 months, the maximum instantaneous gradient across the right ventricular outflow tract by echocardiography after successful SB, SS, KB and JS was 33.2 ± 14.7 mmHg, 30.0 ± 7.8 mmHg, 25.0 ± 11.2 mmHg and  25.4 ± 13.1 mmHg, respectively. When comparing KB to JS, patients treated with KB were younger (6.0 ± 5.2 years vs. 13.6 ± 5.4 years) and more heterogenous (6 with d-transposition of the great arteries, 8 with tetralogy of Fallot, and 3 with truncus arteriosus vs. 9/10 with TOF for JS). This retrospective single-center study involving a small and heterogeneous patient sample suggests that kissing balloon inflation with high-pressure balloons to treat PBS after repair of CTDs is successful and sufficient in most cases and might be preferred in small children and those not needing TPVR. When insufficient or when there is an indication for concomitant TAPVR, complex bifurcation stenting requiring considerable operator experience is necessary. Figure 1. Flowchart of treatment strategies and outcome of 39 patients with pulmonary bifurcation stenosis.

Management of Complex Pulmonary Vein Stenosis at Altitude Combining Comprehensive Percutaneous Interventional Treatment with Sirolimus, Pulmonary Hypertension Medications and Intraluminal Imaging with Optical Coherence Tomography. Shorofsky MJ, Morgan GJ, Mejia E, Rodriguez SA, Greene M, Sheaks P, Ivy D, Zablah JE.Pediatr Cardiol. 2023 Jun;44(5):1125-1134. doi: 10.1007/s00246-023-03102-3. Epub 2023 Feb 1.PMID: 36723625 Take Home Points: Treatment of pulmonary vein stenosis in pediatric patients with congenital heart disease is rapidly evolving with improving outcomes. Sirolimus therapy may be a useful adjuvant therapy in this complex group of patients as it seems to decrease disease progression and need for reintervention. Commentary from Dr. Konstantin Averin (Cohen Children’s Heart Center), catheterization section editor of Pediatric Cardiology Journal Watch: Pulmonary vein stenosis (PVS) in pediatric patients with congenital heart disease is a complex disease that carries a high degree of morbidity and mortality.  There have been significant improvements outcomes over the last few years utilizing a multi-modality treatment approach – including surgery, percutaneous intervention, and medical therapy.  There remains significant variability between centers and treatment algorithms.  The authors report a single center retrospective experience of using systemic sirolimus therapy (SST) in conjunction with pulmonary hypertension mediations and imaging with optical coherence tomography. From October 2020 to December 2021, 10 patients were started and followed on SST – median age at SST initiation 25 months, median weight 10.6 kg (IQR 5.4-21.5 kg).  The authors describe both their PVS medical management protocol and their SST protocol (see below) including how to adjust sirolimus dosing while on bosentan therapy for pulmonary hypertension.  There protocols should be of particular interest to any practitioner considering treatment of this complex group of patients.  Overall, when comparing pre- and post- SST, patients required less frequent catheterizations (3 months   which were also shorter in duration and the severity of disease recurrence was diminished as defined by the degree of vein re-stenosis.  There were no significant serious adverse effects from SST.This study clearly has limitations, including its retrospective nature, the small cohort size, and the inherent heterogeneity in this patient population. The authors conclude that addition of SST helps decrease disease progression with decreased frequency of interventions.  Despite the studies limitations, the conclusions are broadly consistent with the existing literature, suggesting that SST can be a critical adjunct to percutaneous intervention in improving outcomes in patients with moderate to severe PVS.  This study also highlights the need for a multidisciplinary, protocol driven approach to managing pediatric PVS and underscores the necessity of careful consideration of medication interactions, particularly in patients concurrently treated for pulmonary hypertension.  Figure 1. Figure 2.

Effects of time of bed rest on vascular complications after cardiac catheterization in pediatric patients with congenital heart disease: A randomized controlled trial. Cho E, Jang MR, Moon JR, Kim MJ, Kim YM, An YJ, Kang IS, Song J.Heart Lung. 2023 Jul-Aug;60:52-58. doi: 10.1016/j.hrtlng.2023.02.023. Epub 2023 Mar 11. Take Home Points: Minimizing supine bedrest time for pediatric patients following cardiac catheterization can have a significant impact on the stress for the patient and their family. The standard 4 to 6 hours of supine bedrest that many centers practice may be more than is needed. Further studies with a larger cohort of patients that include analysis of sheath size in comparison with patient size could help answer this question more thoroughly Commentary from Dr. Ryan Romans (Kansas City, MO), section editor of Congenital Heart Disease Interventions Journal Watch: Patients who undergo cardiac catheterization via the femoral vessels require supine bedrest following the procedure.  While there is significant central variation, this is frequently done for 2 to 6 hours.  This can be challenging in the pediatric population, especially in younger patients.  They may require sedative medications to assist in ensuring adequate immobility of the leg to prevent complications such as bleeding or hematoma development.  Recent adult studies have shown that 1.5 to 2 hours of supine bedrest is adequate.  However, there is a much wider variability in case duration and sheath size used in pediatric patients.  Given this, the authors thought to determine if there were differences in bleeding incidents, vascular complications, need for sedatives, and pain in patients who are required to complete 2 (experimental group) versus 4 (control group) hours of supine bedrest. A prospective, randomized open label trial was performed from 10/21 to 5/20/2022.  The study included patients who were between 30 days and 16 years old.  Patients with congenital bleeding disorders, in whom femoral vessel access was difficult, those requiring emergency cardiac catheterizations, those requiring ICU level care following the catheterization, and those with an ACT >250 seconds following the catheterization were excluded.  Bleeding and vessel complications were identified via inspection and palpation and scored as a 0 if there was no bleeding, 1 if there was a small amount of bleeding, 2 if there was a palpable hematoma and/or severe bleeding and 3 if there was arterial occlusion/aneurysm/AV fistula/abdominal hematoma).  Pain was assessed using verified rating scales (face–legs–activity–cry–consolability in <3 years, face pain rating scale 4-6 years, and numeric rating system 7 years and older).  At the occlusion conclusion of the case, an ACT was checked, and sheaths were removed. Clo-Sur plus hemostatic pads were applied to all patients and manual compression was performed until hemostasis was achieved.  A sandbag was placed on the site prior to leaving the cardiac catheterization lab.  Bleeding, vessel complications, pain at the access site, and administration of analgesics were evaluated every hour for 4 hours and again in 18 hours in both groups. A total of 84 patients were randomized (42 in each group).  Patients in the experimental group were slightly younger, smaller, and more likely to be taking aspirin or warfarin prior to their procedure than those in the control group.  There were no statistically significant differences in bleeding incidents, vessel complication, pain scores or sedative administration between the groups (no bleeding or vascular complications were seen in either group). This study sought to determine the amount of supine bedrest time needed in pediatric patients following a cardiac catheterization.  There is certainly value in determining this as it can be challenging, especially for younger patients, to remain supine following procedures.  The authors showed that 2 hours appears to be an adequate amount of supine bedrest time following a cardiac catheterization at their center and a small number of patients.  However, more data on this is likely needed before more widespread adoption of this practice.  The center where the catheterizations were performed used sandbags on all access sites.  This is not necessarily a standard practice at many pediatric centers as it can be quite uncomfortable. They did not seek to evaluate whether sheath size used for the procedure has an impact on bleeding/vascular complication risk, pain, and potential need for longer supine bedrest.  Before universally adopting 2-hour bedrest, it would be useful to determine if a sheath size to patient weight ratio placed patients at higher risk for bleeding and/or vascular complications.

Utility of Follow-Up Echocardiograms in Uncomplicated PDA Device Closures Performed During Infancy. Van Pelt E, Reo R, Lovelace C, Eshelman A, Beckman B, Chisolm J, Boe B, Backes C, Cua CL.Cardiol Ther. 2022 Dec;11(4):523-530. doi: 10.1007/s40119-022-00278-2. Epub 2022 Sep 8.PMID: 36074260 Free PMC article. Take Home Points: Device closure of PDAs has replaced surgical ligation as the preferred method including in extremely low birthweight infants Complications/echocardiographic concerns were not seen in long term follow up if they were not seen on the first follow up echo at least 3 months after device closure This should be further evaluated as it has the potential to decrease the number of what appears to be unnecessary echocardiograms Commentary from Dr. Ryan Romans (Kansas City, MO), section editor of Congenital Heart Disease Interventions Journal Watch: Transcatheter device closure has replaced surgical ligation as the preferred method of closing hemodynamically significant patent ductus arteriosus (PDA). This now includes extremely low birthweight infants with the Amplatzer Piccolo Occluder receiving FDA approval for device closure in patients 700 grams and larger. Complications from this procedure include vascular injury, tricuspid valve injury, device embolization, left pulmonary artery (LPA) stenosis, and descending aorta (DAO) stenosis. There complications are typically discovered shortly after device placement. It is unknown if infants who undergo device closure are at risk of development of LPA or aortic stenosis in the longer term. The consensus guidelines on appropriate use criteria of imaging in the follow up of congenital heart disease recommend screening echocardiograms every 5 years after the first 2 years in patients who undergo device closure of PDAs (ACC/AHA/ASE/HRS/ISACHD/SCAI/SCCT/SCMR/SOPE 2020 Appropriate Use Criteria for Multimodality Imaging During the Follow-Up Care of Patients With Congenital Heart Disease). This study sought to determine the utility of this follow up imaging. A retrospective review was performed of all infants (1 year of age or younger) who underwent PDA device closure from 1/2002-6/2020 and did not have any concerns on follow up echocardiogram at least 3 months from device closure. Patients were excluded from analysis if they had other significant congenital heart disease, had at least moderate tricuspid regurgitation on the initial post device echocardiogram, had evidence of LPA and/or DAO stenosis (defined as echo velocity of 2 m/s or greater) on the echo 3 months post device, or did not have a follow up echo at least 3 months post device. 245 patients were reviewed with 147 meeting inclusion criteria. The average gestational age was 29.3 +/- 5.3 weeks, age at time of procedure 141 +/- 217 days, and weight at time of procedure 4.2 +/- 2.8 kg. There were no procedure related mortalities. 80 patients had an echocardiogram performed at least 3 months following the procedure and another at least 12 months after the procedure. There was a statistically significant decrease in LPA velocity, trend towards improvement in LV systolic function, and decrease in LV internal diastolic dimension with a mean follow up of >5 years. There was no change in the DAO velocity. No interventions for LPA stenosis or DAO stenosis were required. This single center study shows that infants who undergo device closure of their PDA do not have any evidence of the development of LPA or DAO stenosis. This, along with results from a similar analysis in an older cohort (Narayan SA, Elmahdi E, Rosenthal E, Qureshi SA, Krasemann T. Long-term follow-up is not indicated after routine interventional closure of persistent arterial ducts. Catheter Cardiovasc Interv. 2015 Jul;86(1):100-4. doi: 10.1002/ccd.25912. Epub 2015 Apr 2. PMID: 25753890), suggest that the current recommendations for follow up echocardiograms in patients who undergo device closure of their PDA and have no/minimal sequela and are asymptomatic may not be necessary. This could decrease the use of resources and decrease overall costs in this patient population.  However, additional longitudinal studies with longer follow up may be necessary to definitively prove this.

Ultra-high pressure balloon angioplasty for pulmonary artery stenosis in children with congenital heart defects: Short- to mid-term follow-up results from a retrospective cohort in a single tertiary center Authors: Shuliang Xia1,2 , Jianbin Li1,2 , Li Ma1,2 , Yanqin Cui1,2 , Techang Liu2,3 , Zhouping Wang2,4 , Fengxiang Li1,2 , Xumei Liu2,3 , Shan Li2,3 , Lu Sun1,2 , Lin Hu1,2, Yubin Liu5, Xun Ma1,2, Xinxin Chen1,2* and Xu Zhang2,4* Journal: Frontiers of Cardiovascular Medicine, 23 January 2023, DOI: 10.3389/fcvm.2022.1078172 Take home points: Ultrahigh pressure balloons, used for pulmonary balloon angioplasty, improves the initial success rates to 78% for branch pulmonary artery stenosis Higher balloon to waist ratios (> 2.57) was associated with a higher initial success rate but also with a higher restenosis rate Commentary from Dr. Thomas Zellers (Dallas, USA), section editor of Congenital Heart Disease Interventions and ACHD Journal Watch: Summary:  This is a single center retrospective evaluation of 37 patients with branch pulmonary stenosis who underwent pulmonary balloon angioplasty with ultrahigh pressure, non-compliant balloons (Conquest and Atlas balloons, up to 30 ATMs) in hopes of improving the initial and mid-term success compared to low and medium pressure balloons.  The authors started with a balloon to waist ratio up to 3 with a maximum ration of 5. They evaluated immediately after the procedure with the longest follow up of only 10 months. The authors used the following to designate success: A ≥ 50% increase in the vessel diameter at the stenotic site A ≥ 50% decrease in the pressure gradient across the stenosis A ≥ 20% decrease in the ratio of right to left ventricular systolic pressure or the ratio decreased to below 0.5. With these parameters, the success rate was 78.4%. The use of Ultrahigh angioplasty balloons significantly increased the pulmonary artery diameter (97%) and reduced the gradients across the stenosis (54%; see Table 4). The RV:LV pressure ratio was only reduced, on average, by 12%. The balloon: waist ratio differentiated between success and failure at > 2.57 with a sensitivity of 0.724 and a specificity of 0.875. The presence of therapeutic tears occurred in 27% of the success group but was not present in the failure group. There were no deaths reported. Sixteen patients suffered adverse events with 11 cases of pulmonary artery injury, 3 patients with pulmonary hemorrhage (resolved with 53 hours), and 2 patients with pulmonary artery aneurysm which did not progress in the short term. Restenosis occurred in 9 patients; 8 of 9 had initial success with balloon:waist ratios > 2.57. Hence, high balloon:waist ratios did not prevent restenosis. Limitations: There are a few limitations to the study. It is retrospective, not controlled for balloon:waist size despite it being a single center study and the follow up was very short so longer term results are not yet known. While it is encouraging that the authors saw a better immediate angioplasty result, the long term results are lacking. Tables: Table 4 Figure 1

Safety of Continuing Anticoagulation Prior to Cardiac Catheterization in Pediatric Patients: A Los Angeles Center Experience. Rao MY, Sullivan PM, Takao C, Badran S, Patel ND. Pediatr Cardiol. 2023 Jun;44(5):1009-1013. doi: 10.1007/s00246-023-03097-x. Epub 2023 Feb 2. PMID: 36725724 Take Home Points:  Anticoagulation was safely continued in pediatric patients undergoing cardiac catheterizations, often including interventions. Individualized peri-procedural decision-making is important and allows for alteration of intra-procedural anticoagulation. Commentary from Dr. Arash Salavitabar (Columbus, OH, USA), section editor of Congenital Heart Disease Interventions Journal Watch: Commentary:  Anticoagulation is a common need amongst patients with congenital heart disease. The authors tackle an important topic that is relevant throughout pediatric and adult cardiac catheterization, reporting on the safety of uninterrupted anticoagulation in pediatric patients undergoing cardiac catheterization in a single center. The 104 patients reported in this manuscript took a variety of anticoagulants, including warfarin, enoxaparin, heparin, fondaparinux, arivaroxaban, and antiplatelet agents. Pre-catheterization INR was available in 58 patients on warfarin and was a median of 2.35 (1.4-6.6). Pre-catheterization anti-Xa levels were available in 43 patients on heparin and 21 patients on enoxaparin and the median levels were 0.41U/ml [0.05–1.96] and 0.63 [0.23–1], respectively. Both arterial and venous access were obtained in 95 cases (66%) and venous access only in 95 cases (29%). Importantly, the largest arterial access obtained was a 7-French sheath in 1 patient and there were 32 (22%) patients who had a venous sheath size greater than 7-French. Despite being on baseline anticoagulation, additional anticoagulation was administered during the procedure in 92 cases at a median bolus dose of heparin or bivalirudin of 72 units/kg [17.5–101.9 units/kg] and 0.5 mg/kg [0.45–0.50 mg/kg)], respectively. Interventions were common, including angioplasty in 67 (42%), stent implantation in 31 (20%), and liver biopsy in 10 (6%). Adverse events were reported in 11 cases (7.6%), including only 2 (1.4%) minor bleeding complications. These 2 bleeding complications were in patients on warfarin with INRs of 2.8 and 3.1. While this study was limited by its retrospective nature, which depends on reported safety and complication variables in the medical records, the authors point out that these rates of adverse events are comparable to those previously reported with cardiac catheterizations. The authors stressed that the peri-procedural anticoagulation management must be individualized and that the intraprocedural anticoagulation dose should be adjusted accordingly. This work shows that there are important alternative management strategies for patients on baseline anticoagulation who often require pauses in their regimen or hospitalizations to bridge therapy prior to their procedures.

The Need for Surgery After Vascular or Cardiac Trauma, or Technical Adverse Events in the Congenital Cardiac Catheterization Laboratory. Holzer R, Batlivala SP, Boe B, Goldstein B, Gudausky T, Hasan B, O'Byrne M, Quinn B, Sathanadam S, Shahanavaz S, Trucco SM, Zampi JD, Bergersen L. Pediatr Cardiol. 2023 Apr;44(4):795-805. doi: 10.1007/s00246-023-03126-9. Epub 2023 Feb 20. Take home points: Life-threatening adverse events occur very rarely during cardiac catheterization in CHD, but not infrequently result in serious adverse outcomes. Adverse events following radiofrequency perforation of the pulmonary valve, atrial septal interventions, and procedures in non-elective cases, in neonates and early after surgery are associated with the highest risk of serious adverse outcomes. Case-specific rather than routine surgical backup may be more appropriate for interventional cardiac catheterization in CHD. rptnb Commentary from Dr. Milan Prsa (Switzerland, Europe), section editor of Congenital Heart Disease Interventions Journal Watch: Surgical interventions are rarely required for life-threatening adverse events (AEs) occurring during cardiac catheterization. Nevertheless, expert consensus  recommends  that surgical backup be available for therapeutic procedures in adult and pediatric CHD.1 As there are no published reports on the odds or outcomes of such interventions, the authors sought to examine the relationship between significant traumatic (tear with flow obstruction, unconfined tear, aneurysm, and/or heart perforation) or technical (coil/device/stent embolization or migration) AEs and adverse outcome (surgery, ECMO, or death). Data from the Congenital Cardiac Catheterization Project on Outcomes (C3PO), collected from 14 centers between January 2014 and December 2017, was analyzed (Table 1). Traumatic AEs were seen in 92 cases or 0.4% of C3PO registered cases and resulted in an adverse outcome in 26% (24/92) or 0.1% of all cases. Surgery was required in 20%, ECMO in 9%, and death occurred in 10% (9/92) of cases with traumatic AEs. Radiofrequency perforation of the pulmonary valve was most likely to result in traumatic AEs (7/69 or 10%), with 57% (4/7) of cases having an adverse outcome. Atrial septal interventions were responsible for 29% of adverse outcomes due to traumatic AEs. Technical AEs were seen in 176 cases or 1.3% of C3PO registered interventional cases and resulted in an adverse outcome in 14% (25/176) or 0.2% of all interventional cases. Surgery was required in 13%, ECMO in 2%, and death occurred in 2% (3/176) of cases with technical AEs. Predictably, adverse outcomes were more likely to occur after traumatic AEs, especially in non-elective/emergent cases (OR 7.1), in neonates (OR 4.8), and in those who had surgery in the previous 30 days (OR 4.2). This multicenter cohort study shows that significant AEs are very rare during cardiac catheterization in CHD, suggesting that immediate surgical or ECMO backup may only be needed for specific cases associated with a high rate of serious adverse outcomes if these AEs occur. Updated expert consensus  recommendations should address appropriate backup provisions more specifically. Table 1. Demographic and clinical data. Bashore TM, Balter S, Barac A et al. 2012 American College of Cardiology Foundation/Society for Cardiovascular Angiography and Interventions expert consensus document on cardiac catheterization laboratory standards update: A report of the American College of Cardiology Foundation Task Force on Expert Consensus documents developed in collaboration with the Society of Thoracic Surgeons and Society for Vascular Medicine. J Am Coll Cardiol. 2012 Jun 12;59(24):2221-305. doi: 10.1016/j.jacc.2012.02.010. Epub 2012 May 8. PMID: 22575325.

Outcomes of manually modified microvascular plugs to pulmonary flow restrictors in various congenital heart lesions. Haddad RN, Bentham J, Adel Hassan A, Al Soufi M, Jaber O, El Rassi I, Kasem M.Front Cardiovasc Med. 2023 Jul 10;10:1150579. doi: 10.3389/fcvm.2023.1150579. eCollection 2023. PMID: 37492157 Take Home Points: Use of modified MVP to decrease pulmonary blood flow is feasible, with the ability to surgically remove the devices up to 6 months post-implant. Increasing experience with this technology is allowing for decrease in procedural complications – device migration and over-circulation. Devices that are specifically designed as intra-luminal pulmonary flow restrictors are needed to facilitate wider adoption and implementation. Commentary from Dr. Konstantin Averin (Cohen Children’s Heart Center), catheterization section editor of Pediatric Cardiology Journal Watch: Surgical pulmonary artery banding is the standard of care for reducing pulmonary blood flow and controlling distal pulmonary artery pressure in patients who are at high risk for definitive biventricular repair or are planned to undergo single ventricle palliation.  Recent case reports have suggested that percutaneous “pulmonary artery banding” can be performed using modified microvascular plugs (MVP) (Medtronic Inc, USA) (Figure 1) implanted in each pulmonary artery.  The authors sought to expand the published experience by gathering multi-institutional data on all patients who underwent transcatheter implantation of modified MVPs as pulmonary flow regulators (PFRs).  This was a descriptive study. Variable techniques for modification of the MVP have been described.  These authors used a carbon steel surgical scalpel blade No. 11 (Swann-Morton®, England).  The blade was used to excise ~50% of the diamond (2 diamonds in the MVP-5Q and 1 diamond in 7Q and 9Q) (Figure 2).  An MVP-5Q was used for vessels up to 4mm, MVP-7Q for up to 6mm, and MVP-9Q for vessels up to 8mm.  From September 2021-September2022 28 pulmonary flow restrictors (PFR) were implanted in 14 patients: median age of 1.6 months (IQR, 0.3-2.3) and weight of 3.1kg (IQR, 2.7-3.6). Most patients were anticipated to have biventricular circulation (9 with large left to right shunt, 2 borderline left ventricles, 2 Taussig Bing anomaly and 1 with hypoplastic left heart syndrome).  There was reduction in pulmonary blood flow in all cases. Fourteen PFRs (7 patients) were surgically explanted at a median of 4.3 months (IQR, 1.2-6) post-implant; 4 are awaiting surgical explant and the remainder (3) were dead or not planned for further repair (palliative).  Explants were performed with forceps or via a snare and sometimes required piecemeal removal.  The authors conclude that use of modified MVPs to decrease pulmonary blood flow is feasible.  The technique described by the authors seeks to address some challenges of this procedure: distal device migration can be mitigated by oversizing the MVP and their approach to creating stable size fenestration seems to decrease the chance of excessive pulmonary blood flow.  Importantly, the MVPs were able to be removed in 50% of patients up to 6 months post-device implant suggesting this approach can be used to bridge patients to a more definitive repair later in life.  To facilitate wider adoption and implementation of this technique devices specifically designed as intra-luminal pulmonary flow restrictors are needed. Figure 1. Figure 2.