Congenital Heart Interventions

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.

Zhang K, Yang P, Yin D, Li M, Liang X, Lv T, Zheng M, Xiang P. Cardiology. 2023;148(1):62-71. doi: 10.1159/000528115. Epub 2022 Nov 22. PMID: 36413978; PMCID: PMC10015750. Take home points: Transcatheter closure of a ventricular septal defect (VSD) may lead to significant aortic regurgitation (AR) requiring unplanned surgery. Risk factors for unplanned surgery following transcatheter VSD closure include preprocedural mild AR, larger VSD size, infra-cristal VSD, and smaller sub-aortic rim (<2 mm) Percutaneous device closure of VSDs in the absence of a clear indication may do more harm than good. Commentary from Dr. Milan Prsa (Switzerland, Europe), section editor of Congenital Heart Disease Interventions Journal Watch: Ventricular septal defects (VSD) are one of the most common forms of congenital heart disease requiring intervention. Although surgical closure is more commonly performed, successful and safe transcatheter closure is increasingly reported in large series of selected patients. However, new-onset or worsening aortic regurgitation (AR) is an increasingly recognized complication. The authors of this retrospective study sought to determine the incidence and risk factors for significant AR requiring unplanned surgery following percutaneous device closure of VSD. Between July 2009 and September 2018, 876 children (441 male, age 49.8 ± 29.8 months, weight 16.2 ± 6.4 kg) with isolated perimembranous VSD and no more than mild aortic valve prolapse or AR, underwent transcatheter VSD closure at Children's Hospital of Chongqing Medical University. New-onset or increasing AR that was more than mild was diagnosed by both transthoracic color Doppler echocardiography and ascending aorta angiography. A total of 29 children (3.3%) required unplanned surgery, 6 due to new-onset and 23 due to increasing AR during the procedure. During a median follow-up of 7.3 years, no significant new-onset or increasing AR was seen in children who did not undergo unplanned surgery. Compared to those with ≤mild AR during the procedure, patients needing surgery had a higher proportion of aortic valve prolapse (69 vs. 12.3%), mild AR at baseline (79.3 vs. 2.4%), infracristal VSD (31 vs. 1.8%), asymmetric occluder use (51.7 vs. 9.6%), a larger VSD diameter by angiography (3.59 ± 1.80 vs. 4.45 ± 2.02 mm), a smaller sub-aortic rim (0.9 ± 1.0 vs. 3.5 ± 1.0 mm), higher PASP (34.5 ± 11.7 vs. 30.1 ± 8.7 mmHg), and a larger occluder size (7.4 ± 1.9 vs. 6.3 ± 1.5 mm). On univariate and multivariate logistic regression analyses, risk factors for new-onset or increasing AR requiring unplanned surgery were aortic valve prolapse, preprocedural mild AR, intracristal VSD, larger VSD diameter and smaller sub-aortic rim. This retrospective single-center study including a large cohort of patients showed that significant AR developed in 3.3% of children undergoing percutaneous device closure of VSD. Unsurprisingly, preprocedural aortic valve prolapse or AR, intracristal VSD, and a larger VSD with a smaller sub-aortic rim were identified as risk factors. Unfortunately, the indications for VSD closure are not discussed and the patient data suggest that most patients had pressure restrictive perimembranous VSDs, where intervention may not be warranted. In addition, the term intracristal VSD is used to define a defect located at the 12:00-1:30 o'clock position in the transthoracic echocardiographic parasternal short-axis view, which is likely to correspond to an outlet VSD (whether perimembranous or doubly committed juxta-arterial) according to a more accepted nomenclature.1 These VSDs are more often associated with AVP or AR, and have a higher risk of complications during transcatheter closure, making the surgical option likely more appropriate. Finally, this study highlights the pitfalls of unchecked zeal to close pressure restrictive, mostly perimembranous VSDs, which is unsupported by clinical evidence. References

Supraventricular Arrhythmia Following Patent Foramen Ovale Percutaneous Closure. Guedeney P, Laredo M, Zeitouni M, Hauguel-Moreau M, Wallet T, Elegamandji B, Alamowitch S, Crozier S, Sabben C, Deltour S, Obadia M, Benyounes N, Collet JP, Rouanet S, Hammoudi N, Silvain J, Montalescot G. JACC Cardiovasc Interv. 2022 Nov 28;15(22):2315-2322. doi: 10.1016/j.jcin.2022.07.044. Epub 2022 Aug 22.PMID: 36008269 Commentary from Dr. Wendy Whiteside (Ann Arbor, MI, USA), section editor of Congenital HeartDisease Interventions Journal Watch: Atrial arrythmias are cited among the most common complications post PFO closure. Published randomized controlled studies have reported an overall low rate (1.7-7.4%) of new atrial fibrillation (AF) after PFO closure, however this rate is based on patient reported symptomatic episodes, so the true incidence is unclear.  Guedeney et al present a single-center prospective cohort study to determine the incidence, timing, and determinants of supraventricular arrhythmias following PFO closure in adults using a standardized rhythm monitoring protocol in all their PFO patients between June 2018 to October 2021 at their center in Paris, France. Most patients received Amplatzer or Occlutech occlude devices. A total of 225 patients were included. Patients were excluded if they had a prior supraventricular arrhythmia. Patients were separated into two groups—the high-risk group for AF (age >55 yr, associated cardiovascular risk factors, prior palpitations, or documented supraventricular ectopic activity) received an implantable loop recorder (ILR), and all other patients received a 4-week external loop recorder (ELR). The primary endpoint was incidence of AF, atrial flutter, or supraventricular tachycardia (SVT) lasting >30 seconds within 28 days of PFO closure procedure.  The primary endpoint occurred in 47/225 patients (20.9%) including 13 (9.9%) with ELR and 24 (28.9%) of high-risk patients with ILR at a median of 14 days (IQR 6.5-19 days) after the procedure.  Only 4 more cases of supraventricular arrhythmia were diagnosed beyond 28 days (53-455 days). Just over half of patients reported symptoms. Antiarrhythmic agents were started in 60.8% of patients, primarily those with symptoms. Cardioversion (electrical or chemical) or ablation were 13 patients total with about 25% of patients requiring unplanned medical visits of hospital admissions.  By stepwise multivariate logistics regression, independent risk factors for the primary endpoint included older age (adjusted OR 1.67 per 10-year increase), diameter of left atrial disk >25 mm (adjusted OR 2.67) and male sex (adjusted OR 4.78). Patients with arrhythmias did not have a higher risk for cerebrovascular events in follow-up. This study therefore uncovered many patients, many of whom may be asymptomatic, with atrial arrhythmias post-PFO closure, particularly in high-risk populations suggesting our prior numbers were grossly underestimated. These events occur soon after device placement and with few recurrences beyond 1-month post-procedure.  One hypothesis for these atrial arrhythmias is device-related atrial irritation.  The finding of larger diameter left atrial disk and temporal association with the procedure/device placement are indirect evidence of these arrythmias being procedure related.  This then begs the question of whether ASD closure may also have higher rates of occult atrial arrhythmia that is undetected.  ASD closure is often performed in younger patients who do not have the same risk factors for AF as the population in these PFO trials/studies however devices used are often larger relative to atrial size in these smaller patients. The question remains; however, does it matter, particularly if many events are asymptomatic and self-limited?  This study was not powered to evaluate the clinical consequences and management of these events and so this question cannot be answered at this time. There are ongoing trials to assess benefit of medical therapy to prevent atrial arrhythmias after PFO closure, which may help to evaluate the clinical benefit of such practices. 

Follow-up of hypertension after aortic coarctation stent implantation based on safe and effective re intervention: a retrospective cohort study. Zhang W, Schneider M, Zartner P.J Thorac Dis. 2022 Oct;14(10):3924-3933. doi: 10.21037/jtd-22-1134.PMID: 36389339 Take home points: Hypertension is common with coarctation of the aorta and needs to be evaluated longitudinally. Hypertension decreased after coarctation stent implantation but in-stent restenosis (> 10 mmHg gradient) was accompanied by recurrent hypertension. The younger the age at stent implantation, the less the incidence of hypertension at follow up. However, the younger the age at stent implantation, the more likely (80%) the patient is to require more than one intervention. Hypertension was present in 88% pre-stent (native and recurrent coarctation) and in 28% at last follow-up post stent implantation, suggesting that long term follow-up is required even with a good result. Commentary from Dr. Thomas Zellers (Dallas, USA), section editor of Congenital Heart Disease Interventions and ACHD Journal Watch: Summary: This is a retrospective evaluation of hypertension in 88 consecutive patients with coarctation following stent implantation from the German Pediatric Heart Centre between 2004 and 2012. Long term follow-up (up to 12 years) was available in 82 patients. Stent implantation was indicated for catheter measured gradients > 20 mmHg or angiographic narrowing > 50%. Patients were not eligible for study if they had long segment coarctation or required a palliative stent. Patients were followed at 1, 3, 6 and 12 months and then yearly. BP measurements were performed after 5 minutes of rest and 3 measurements were averaged. Hypertension was defined as systolic BP > 140 mmHg and /or diastolic BP > 90 mmHg or a BP > 95th%’ile for age, height and weight. Anti-Hypertensive medications like betablockers, ACE inhibitors, ARBs, calcium channel blockers and diuretics, or a combination of more than one, were used when hypertension was found. The average follow up was 77 months (6-151 months) with one patient death. Restenosis was common (80%) with 40%, 22% and 17% requiring 1, 2 and 3 reinterventions, respectively. A total of 198 interventions were performed (including the initial 82 stent implants). Complications occurred in 3%, half of which were related to aneurysm formation. Hypertension was present in 88% of patients prior to initial stent implantation and in 28% at last follow-up, all of whom required antihypertensive medications. There was no difference in incidence of hypertension at the time of implant for native vs recurrent coarctation. At follow-up, it was found that the younger the patient at initial implant, the lower in the incidence of hypertension but the more likely the need for at least one additional reintervention. Figure 1. Hypertension recurred with in stent restenosis. Figure 2 (example) Limitations: This is a retrospective study from a single center which involved stent implantation in younger age groups than found in many studies. The number of patients is modest but the follow up is fairly complete. The follow-up information in younger patients in this study could be used to inform how these patients should be followed in the future. What we learned and could use from this study: Stent implantation is safe even in younger patients with a low incidence of complications. Hypertension is common in follow up and may herald re-stenosis and the need for a re-intervention. Even in patients with a good result, hypertension can be found, similar to other studies, and patients require antihypertensive medications. In this study, the incidence of hypertension at last follow up was 28%. The younger the age at implant, the more likely they are to require at least one more reintervention. However, the younger patients had less incidence of hypertension at follow up suggesting that earlier intervention may play a role in reducing the incidence of hypertension at follow-up. Long term follow up is needed in these patients even when they have had a good hemodynamic result. Tables:

Balloon angioplasty and stent implantation within 30 days postcongenital heart surgery (CHS) in children. Quandt D, Callegari A, Niesse O, Meinhold A, Dave H, Knirsch W, Kretschmar O. J Card Surg. 2022 Oct 23. doi: 10.1111/jocs.17057. Online ahead of print. PMID: 36273426 Take Home Points: Balloon angioplasty and stent implantation can be performed safely in immediate post-operative period. Stent implantation more reliably achieves relief of vessel stenosis. Commentary from Dr. Konstantin Averin (Cohen Children’s Heart Center), catheterization section editor of Pediatric Cardiology Journal Watch: Interventional cardiac catheterization in the immediate post-operative period is generally considered high risk.  The traditional teaching has been to delay intervention for 4-6 weeks after the operation to allow for healing and scar formation.  However, there is increasing data to suggest that intervention early after congenital heart surgery has a favorable risk profile if performed selectively.  Quandt et al sought to report on the safety and efficacy of balloon angioplasty (BAP) and stent implantation (SI) within 30 days post-congenital heart surgery (CHS) in children from a single center. Over a 20-year period (01/2001-01/2021) a total of 127 procedures were performed in 104 patients - 31 BAP and 96 SI with no significant differences in baseline demographics.  The median time from CHS to the intervention was 6.5 days but patients who underwent SI were only 4 days removed from CHS compared to 14 for BAP.  SI resulted in greater increase in vessel diameter both in absolute size and relative to adjacent structures.  SI also achieved an increase diameter of >50% more often than BAP (94% v 70%).  The rate of major complications was modest (4.8%) with no intra-procedural mortality.  There was one case in which the authors suspect rupture of a suture line requiring VA-ECMO use with full recovery.  There was no relationship between adverse events and severity of the stenosis. The authors conclude that BAP and SI is feasible and effective following CHS.  SI appears to provide more reliable relief of stenosis compared to BAP and should be favored when treating these critically ill infants.  These insights have the potential to guide clinicians in providing optimal care for children with congenital heart disease during the critical early postoperative period.

Adverse Events Associated with Cardiac Catheterization in Children Supported with Ventricular Assist Devices. Power A, Navaratnam M, Murray JM, Peng LF, Rosenthal DN, Dykes JC, Yarlagadda VV, Maeda K, Almond CS, Chen S.ASAIO J. 2022 Sep 1;68(9):1174-1181. doi: 10.1097/MAT.0000000000001627. Epub 2021 Dec 28.PMID: 34967779 Take Home Points: Ventricular assist devices are increasingly being used as a bridge to heart transplant. Cardiac catheterization can be useful to help evaluate and optimize the support and intervene as needed. Need for ICU support, BiVAD support, and clinical deterioration prior to the catheterization are risk factors for adverse events related to the catheterization. Commentary from Dr. Ryan Romans (Kansas City, MO), section editor of Congenital Heart Disease Interventions Journal Watch: Ventricular assist device (VAD) use has increased as a viable means of mechanical circulatory support for children over the last 2 decades (now more than 50% of pediatric dilated cardiomyopathy patients on VADs at time of transplant), with improving technology and experience with management leading to improved outcomes. Cardiac catheterization can provide essential diagnostic information in patients supported with VADs (filling pressures, fluid status, pulmonary vascular resistance, etiology of hypoxia) and is also at times necessary for interventional procedures. Additionally, ramp studies (serial hemodynamic measurements while adjusting VAD settings) can be performed during a catheterization to help optimize VAD settings. This study is the first to evaluate the safety of cardiac catheterization in pediatric patients on VAD support. A retrospective review was performed of all patients on VAD support who underwent cardiac catheterization at Lucile Packard Children’s hospital from 1/2014-9/2019. The indication for catheterization was categorized as hemodynamic assessment in stable clinical condition, hemodynamic assessment due to worsening clinical status, and planned intervention. Major adverse events (AE) were defined as arrhythmia leading to hemodynamic compromise/requiring treatment, respiratory failure >24 hours after cath, acute kidney injury, major bleeding, stroke within 7 days, pericardial effusion within 7 days, device malfunction/pump thrombus, bacteremia within 7 days, death within 7 days, need for CPR/ECMO, or other. AEs were reviewed by two blinded authors who determined if they were related to the catheterization or not based on clinical notes (i.e., if dialysis was already planned at the time of the catheterization AKI was not a complication of the catheterization). A total of 71 patients were supported with VADs; of these 39 patients underwent a total of 60 cardiac catheterizations. Many of these patients (54%) had dilated cardiomyopathy with single ventricle congenital heart disease (1V-CHD) the next most common (31%). 60% of the patients were in the ICU at the time of the procedure. 63% of the catheterizations were performed for hemodynamic assessment in patients in stable clinical condition (most to assess candidacy for heart transplant) with the remaining done in patients with deterioration clinical condition. Ramp assessments were included in 37% of catheterizations. Interventions were performed in 25% of catheterizations (planned in 11, unplanned in 4). During the catheterization, 19 (32%) cases required a fluid bolus (n=9) and/or vasoactive boluses (n=8)/escalation in vasoactive infusions (n=5). 12/60 (20%) cases had at least one adverse event noted (total AEs 16) with 9 of these in 8 different patients determine to be possibly related to the catheterization. The adverse events were respiratory failure (n=6), major bleeding (n=2) and arrhythmia (n=1). All patients who had an AE were in the ICU prior to their catheterization. Additionally, AEs were more likely in patients on BiVAD support and in those undergoing catheterization for worsening clinical condition. This single center study shows that cardiac catheterizations in pediatric patients supported with VADs are reasonably safe (cases had a 13% AE rate). Not surprisingly, AEs were more common in those hospitalized in the ICU, on BiVAD support, and who have had clinical deterioration prior to the catheterization. The most common complication was need for increased respiratory support in patients who were already  on high flow or positive pressure respiratory support. Importantly, there were no cardiac arrests/need for ECMO support.

Balloon Interrogation of Intervening Tissue: A Novel Method to Decide Strategy for Closing Multiple Atrial Septal Defects. Dalvi B, Bhalgat P. Circ Cardiovasc Interv. 2022 Sep;15(9):e012048. doi:10.1161/CIRCINTERVENTIONS.122.012048. Epub 2022 Sep 20.PMID: 36126135 Free article. Take Home Points:  Balloon interrogation of patients with two secundum atrial septal defects beyond the typical “stop-flow” and “balloon stretch” techniques allow for determination of candidacy for a single-device approach to percutaneous device closure. If balloon interrogation of one of two ASDs does not result in intervening tissue impingement and cessation of flow through the 2nd defect, it is important to separately interrogate the 2nd defect to determine if that is a single-device candidate. Commentary from Dr. Arash Salavitabar (Columbus, OH, USA), section editor of Congenital Heart Disease Interventions Journal Watch:  The authors report on an approach to a challenging dilemma of performing device closure of two separate ostium secundum atrial septal defects (ASDs). The clinical decision of whether to use a single device to cover both defects and/or use multiple devices can be a difficult judgement call.  This was a prospective study of 20 patients (age range 3-67 years, weight range 11-71 kg) with 2 secundum ASDs who underwent device closure. In these patients, an Amplatzer sizing balloon was inflated across one of the defects until flow through that defect stopped completely. This was then further inflated to determine whether the intervening tissue between the ASDs demonstrated enough mobility to also stop flow through the 2nd defect. A “successful balloon interrogation” was if this technique stopped flow through both defects and the diameter at which flow stopped through both defects was referred to as the “balloon interrogated diameter” (Figure 4). If flow did not cease in the 2nd defect, that additional defect was crossed separately from the contralateral femoral vein and balloon interrogation was performed using the same technique to determine if a single device could be utilized within that defect (Figure 5). An “unsuccessful” balloon interrogation resulted in a 2-device strategy. When a single device was used, 1-2mm were added to the balloon-interrogated diameter, whereas in the 2-device approach, 1-2mm were added to each balloon-stretched diameter. When deploying 2 devices, the smaller device was delivered first, followed by the larger device. A single device was implanted successfully and without residual shunt in 15/20 patients. Four of the 15 patients had an initially unsuccessful balloon interrogation but was subsequently successful when performed in the 2nd defect. The remaining 5 patients received 2 devices. Although statistical analysis was not reported, the authors found that successful single-device approach was more likely if the smaller defect was <10 mm in diameter, that the width of tissue separating defects was shorter in patients who received a single device, as compared with 2 devices (5.2±2.4 mm for 1 versus 8±1.1 mm for 2). Successful single-device strategy also tended to be in younger patients. Importantly, the single-device strategy required use of a significantly larger (35±14%) device and the Amplatzer Septal Occluder was used in all of these single-device cases. This study provides a logical, stepwise approach to interrogation and decision-making in percutaneous treatment of two secundum atrial septal defects. The authors provide a small cohort with success using this strategy of triaging patients who are candidates for a single-device approach. Given that a larger device is needed to perform this single-device strategy, it will be important to have subsequent follow-up data regarding device-related complications, such as erosion.

Renal Function After Transcatheter Piccolo Patent Ductus Arteriosus Closure With Contrast Angiography in Extremely Premature Infants   Herron C, Forbes TJ, Kobayashi D.Am J Cardiol. 2022 Oct 15;181:113-117. doi: 10.1016/j.amjcard.2022.07.013. Epub 2022 Aug 13.PMID: 35970628   Take home points: In extremely premature infants, renal function improved significantly after transcatheter PDA closure with contrast angiography, even in infants with pre-existing renal insufficiency. The benefit of transcatheter PDA closure on renal function may outweigh the risk of contrast-induced nephropathy in extremely premature infants, even in those with significant pre-existing renal insufficiency.     Commentary from Dr. Milan Prsa (Switzerland, Europe), section editor of Congenital Heart Disease Interventions Journal Watch:   As transcatheter closure of the patent ductus arteriosus (TC-PDA) becomes increasingly adopted as an alternative to surgical ligation in preterm infants, procedural safety becomes paramount. Contrast-induced nephropathy (CIN) is a known procedural complication in premature infants, especially in those with pre-existing renal insufficiency caused by a large shunt. Although no infants developed CIN in the premarket trial of the Amplatzer Piccolo™ Occluder with an average of 2.5 mL ± 1.7 mL/kg of contrast used, the consensus guidelines call for minimal (2 to 4 mL) or no contrast use in premature infants with pre-existing renal dysfunction [1,2]. The authors sought to test the hypothesis that the benefit of TC-PDA on renal function outweighs the potential risk of CIN in extremely premature infants.   The short-term effect of contrast use on renal function was studied in 59 infants weighing ≤2 kg who underwent successful TC-PDA over a period of 6 years (2016-2021). Serum creatinine and BUN were measured at baseline, at 24 hours, and 5 to 7 days after PDA closure. Significant renal insufficiency was defined as serum creatinine ≥1.0 mg/dL and was present in 31 patients (19%). Median contrast amount used for proximal descending aortography before device closure +/- pulmonary arteriography after device positioning within the PDA was 1.9 mL/kg (0.6 to 6.1). The cohort was compared to a surgical ligation group of 101 infants who had a lower weight at the time of procedure, higher incidence of mechanical ventilation, and higher baseline serum creatinine and BUN. Renal function improved progressively in both groups, faster and more significantly in the transcatheter group, but there was no significant difference in improvement between the two groups (Figure 1).     Figure 1. Tables showing the change in renal function after PDA closure in all patients with available data (left) and the subgroup with pre-existing renal insufficiency and available data (right).   This retrospective single-center study showed a significant decrease in renal biomarkers within a week after TC-PDA in extremely premature infants, despite use of contrast angiography, even in infants with pre-existing renal insufficiency. Although contrast use should be minimized and the procedure can be performed safely at bedside in the NICU with TTE guidance only, centers beginning in their experience with TC-PDA should not be discouraged from using contrast angiography, as the benefit of PDA closure may outweigh the risk of CIN in extremely premature infants.   References 1. Sathanandam SK, Gutfinger D, O'Brien L et al. Amplatzer Piccolo Occluder clinical trial for percutaneous closure of the patent ductus arteriosus in patients ≥700 grams. Catheter Cardiovasc Interv. 2020;96(6):1266-1276. doi: 10.1002/ccd.28973. 2. Sathanandam S, Gutfinger D, Morray B et al. Consensus Guidelines for the Prevention and Management of Periprocedural Complications of Transcatheter Patent Ductus Arteriosus Closure with the Amplatzer Piccolo Occluder in Extremely Low Birth Weight Infants. Pediatr Cardiol. 202;42(6):1258-1274. doi: 10.1007/s00246-021-02665-3.

The epidemiology and outcomes of pericardial effusion in hospitalized children: a national database analysis Sasaki J, Sendi P, Hey MT, Evans CJ, Sasaki N, Totapally BR. Journal of Pediatrics 2022;249:29-34. doi: 10.1016/j.jpeds.2022.07.005. Epub 2022 Jul 11. PMID: 35835227   Take home points: 1)  KIDS inpatient database, authors found a prevalence for pericardial effusion of 0.1% in inpatients; pericardial drainage occurred in 12.3% of these patients 2) Top diagnoses in hospitalized patients with pericardial effusion were structural heart disease (40%), post cardiac surgery (28%), rheumatological diagnosis (15%), hematologic malignancy (11%), solid organ tumor (9%) and organ transplant (2.6%). 3) Mortality among patients with pericardial effusion was 6.8%; mortality was higher in younger patients with solid organ tumors and lower in older patients with cardiac or rheumatologic diagnoses.   Commentary from Dr. Thomas Zellers (Dallas, USA), section editor of Congenital Heart Disease Interventions and ACHD Journal Watch: Summary:  The authors used the Healthcare Cost and Utilization Projects (HCUP) Kids inpatient database from the Agency for Healthcare Research and Quality (AHRQ). This is the largest and most comprehensive database for all payor pediatric inpatients. The authors performed a retrospective analysis of all hospital admissions for children with pericardial effusions using specific ICD-10  codes that would allow for diagnoses, pericardial drainage procedures and mortality. Clinical classification software (CCS) was also used to identify a broad range of etiological factors associated with pericardial effusion. They created 7 etiologic categories which included cardiac surgery, cardiac structural disease, organ transplant, hematologic malignancy, solid organ tumors, rheumatologic diagnoses and OTHER. Infectious etiologies could not be identified separately. The authors further separated the cohorts by age at the time of diagnosis: neonate (< 28 days), infant (> 28 days but < 1 year), preschool (1-5 years), child (6-12 years) and teen (13-20 years). There were 6.26 million patients evaluated and 6417 (0.1%) were diagnosed as having a pericardial effusion. The prevalence was highest in infants (0.28%) and lowest in neonates (0.04%). The prevalence was twice as high in black children (0.15%) compared to white children (0.08%). In children with pericardial effusion, the most common diagnoses were (in order) structural heart disease, post op cardiac surgery, rheumatologic diagnosis, hematologic malignancy, solid organ tumor and post organ transplant. Cardiac structural diagnoses were more prevalent in neonates and infants, whereas the other diagnoses were seen more frequently in older age groups. Pericardial drainage occurred in 12.3% of the patients. Drainage occurred most frequently in teenagers and occurred least frequently in the 6-12 year old age range. Pericardial effusion drainage was required most commonly in post op cardiac surgery patients and those with hematologic malignancy. It was least frequent in patients with rheumatologic diagnoses. Mortality occurred in 6.8% of children with pericardial effusion. Of those who required pericardial drainage, 10.8% died. Using an adjusted risk for mortality model, the adjusted risk for mortality was lowest in older age groups and highest in neonates. Cardiac structural disease and rheumatologic disease was associated with the lowest adjusted mortality risk; it was highest in patients with solid organ tumor. Other associated risks that increased risk adjusted mortality included acute respiratory failure, acute kidney injury, need for dialysis and need for pericardial drainage. This paper represents one of the largest studies- using a single database- offering current insights into the etiologies of pericardial effusion in hospitalized patients. It is a retrospective study, however, and the study was not geared to explore the reasons for drainage or the nuances surrounding mortality. The idiopathic etiologies (often viral illness) were not evaluated except as an OTHER category and little information is given about this group of patients. There is also no information as to why a patient had an echocardiogram or a point of care ultrasound to diagnose the pericardial effusion nor any information about the qualifications of the person doing the ultrasound or the severity of the effusion. So, it is possible that the denominator may be over or underestimated.

Short- and medium-term outcomes for patent ductus arteriosus stenting in neonates ≤2.5 kg with duct-dependent pulmonary circulation. Nasef MA, Shahbah DA, Batlivala SP, Darwich R, Qureshi AM, Breatnach CR, Linnane N, Walsh KP, Oslizlok P, McCrossan B, Momenah T, Alshahri A, Abdulhamed J, Arafat A, Tamimi OA, Diraneyya OM, Goldstein BH, Kenny D. Catheter Cardiovasc Interv. 2022 Oct;100(4):596-605. doi: 10.1002/ccd.30351. Epub 2022 Jul 29.PMID: 35904221   Take Home Points: 1) Stenting the patent ductus arteriosus in infants ≤ 2.5 kg with DDPBF is technically feasible and achieves short-term outcomes comparable to or better than surgical systemic-to-pulmonary shunting. 2) There is relatively high incidence of morbidity with this procedure, especially related to arterial access.       Commentary from Dr. Konstantin Averin (Cohen Children’s Heart Center), catheterization section editor of Pediatric Cardiology Journal Watch: Stenting of the patent ductus arteriosus (PDA) has become an accepted alternative to a surgical systemic-to-pulmonary shunting (SPS) in patients with ductal dependent pulmonary blood flow DDPBF).  Infants who are ≤ 2.5 kg are at highest risk for SPS, so PDA stenting is an attractive option in this patient population.  The authors sought to assess procedural and short-term outcomes in infants ≤ 2.5 kg undergoing PDA stenting for DDPBF using data from 4 large cardiac centers. From March 2007 to February 2020, 38 patients – median age at procedure 10 days (IQR 6-15), median procedural weight 2.2 kg (IQR 2-2.4 kg) (11 under 2.0kg) - underwent PDA stenting.  There were a variety of diagnoses, but a majority had pulmonary atresia or pulmonary stenosis (71%).  A majority (79%) of the PDA’s had complex anatomy with a tortuosity index of II or III.  In 47% of patients the procedure was performed via the femoral artery, while the carotid artery was used in 8 (21%), umbilical artery in 6, axillary artery in 4, and femoral vein in 2 (Figure 1). Patient outcomes are summarized in Figure 3.  Successful stent implant was achieved in 92% of initial procedures (35/38) with no procedural deaths.  There was a high incidence (18%, 7/38) of serious adverse events related to the primary procedure (Figure 2) – most commonly related to carotid and femoral artery access.  The thirty-day survival for the entire cohort was 97%.  Twenty patients required reintervention. The authors conclude that PDA stenting in infants ≤ 2.5 kg is feasible and effective.  The authors should be commended for providing important data on a challenging procedure in a very challenging patient population.  Despite the relatively high risk of access related complications, it is interesting that none of the patients who underwent axillary artery access had any complications related to this.  Recognizing that this was one of the access sites used least frequently further investigation as to whether the axillary artery may be a safer approach for this procedure is warranted.  This study highlights the need for additional data to inform decision making around PDA stenting.  

Transcatheter Recanalization of Atretic Pulmonary Veins in Infants and Children. Patel JD, Mandhani M, Gray R, Pettus J, McCracken CE, Thomas A, Bauser-Heaton H, Kim DW, Petit CJ.Circ Cardiovasc Interv. 2022 Jun;15(6):e011351. doi: 10.1161/CIRCINTERVENTIONS.121.011351. Epub 2022 Jun 21.PMID: 35727880 Review.   Take Home Points: Pulmonary vein stenosis is a complex disease process that includes anatomic vascular stenosis and myofibroblastic proliferation. Recanalization of atretic pulmonary veins is successful in the modern era with a low complication rate. Recanalized veins frequently become atretic again and long term outcomes in this patient population remain poor. Commentary from Dr. Ryan Romans (Kansas City, MO), section editor of Congenital Heart Disease Interventions Journal Watch:   Pulmonary vein stenosis (PVS) is a unique disease within the world of congenital heart disease in that it is not a purely vascular lesion (such as aortic coarctation or pulmonary artery stenosis). There has been limited success achieving durable outcomes following both surgical and transcatheter interventions. Aggressive myofibroblastic proliferation contributes to disease progression over time and, if untreated, can lead to the development of pulmonary vein atresia (PVA). Thus far there are no report on treatment of PVA in a large cohort.   A retrospective review of all pediatric patients with a diagnosis of PVS from 2008-2020 at Children’s Healthcare of Atlanta was performed. All CT angiograms and angiography was reviewed to confirm accuracy of specific vein involvement and progression of disease by two of the study’s authors. The degree of stenosis/atresia was defined by the previously described criteria as depicted in this diagram. Attempts at recanalization of PVA was made by the interventional cardiologist. Any vein that was not successfully recanalized was deemed a failure for the purposes of the study regardless of whether recanalization was attempted. A total of 131 patients underwent treatment for PVS during the study period, 61 (46.6%) of whom developed PVA of at least one pulmonary vein. These patients were compared with the 70 patients who did not develop PVA (control group). The only demographic differences between the groups were a lower birth weight (1.35 versus 2.35 kg), more likely single vessel versus multiple vessel disease (30% versus 60.7 percent), and shorter follow up (1.5 versus 2.9 years) in the PVS group. There was significant early mortality in both groups (78.6% survival at 1 year in PVA group, 74% in PVS) with persistent but lower rate of later mortality (70%, 67.5%, and 60.9% survival at 2, 5, and 10 years in PVA, 74%, 66.2%, and 66.2% in PVS). There was not a significant difference in survival between the two cohorts.     There were 97 total atretic pulmonary veins in 61 patients. The left upper pulmonary vein was most commonly affected, followed by the left lower pulmonary vein and then right upper pulmonary vein. There was an era affect in identification of pulmonary vein atresia with 11 diagnoses from 2008-2012, 30 from 2013-2016, and 56 from 2017-2020. 47/97 atretic veins were successfully recanalized. Again, there was a difference between eras with 0/11 from 2008-2012 recanalized, 8/30 (27%) from 2013-2016, and 39/56 (70%) from 2017-2020. Following recanalization, 20 patients underwent drug eluting stent implantation, 16 balloon angioplasty, 7 stent dilation, and 4 bare metal stent implantation. The adverse event rate was low-2 cases of transient heart block and 1 case of stent embolization. In follow up, 53.1% of recanalized veins remained patent at 6 months and 42.6% at 2 years.   This study shows that transcatheter recanalization of atretic pulmonary veins can achieve acute success with a very low complication rate. Interestingly, there was not a significant difference in mortality in patients with PVA versus those with PVS. The authors hypothesize that this may be due to the development of collateral drainage in slowly developing PVA. Additionally, recanalization has improved in recent years, and this may contribute to improved survival in the PVA atresia group. Lastly, this patient population at CHOA is routinely treated with systemic sirolimus in the modern era which may improve overall outcomes. The authors comment on the importance of the development of a PVS Program in the ongoing success in treating this patient population. Given the high rate of recurrence (only 20.6% of atretic veins were successfully recanalized and remained patent at follow up), these patients require close surveillance with CT angiography and repeated cardiac catheterizations.   

Transcatheter closure of ventricular septal defects: preliminary results in children weighing 10 kg or less Kamran Mirza M, Shaad Abqari, Azam Haseen and Mayank Yadav   Take Home Points Patients ≤10kg with least a 3mm tissue rim separating the VSD from the AV or TV, and no/minimal baseline aortic regurgitation were considered for device closure with a 90% success rate ADO I devices were used for defects with a septal aneurysm, ADO II for smaller defects, and muscular VSD device for larger defects via retrograde and antegrade approaches Commentary from Dr. Arash Salavitabar (Ann Arbor, MI, USA), section editor of Congenital Heart Disease Interventions Journal Watch:   The authors report on the results of a retrospective single-center study on the feasibility and short-term outcomes of percutaneous ventricular septal defect (VSD) closure in patients weighing ≤10kg. Patients were included is they had a hemodynamically significant VSD by both clinical and echocardiographic and catheterization criteria. Patients ≤10kg were considered amenable for device closure if there was at least a 3mm tissue rim separating the defect from the AV or TV, and there was no or minimal baseline aortic regurgitation.   This procedure was performed in 50 patients, 47 of which were performed under conscious sedation and all of which were approached via the right internal jugular vein and right femoral vein and artery. Mean patient weight was 7.46 ± 1.89 kg (2.3–10 kg) and mean age was 19.4 ± 11.88 months (4–48 months). VSD types consisted of 35 (70%) perimembranous, 7 (14%) upper muscular, 3 (6%) mid-muscular, 2 (4%) lower muscular, 3 (6%) outlet muscular. Pulmonary hypertension was present in 29 (58%) patients, which was defined based on mPAP >25mmHg (as opposed to being defined by pulmonary vascular resistance). Retrograde device closure was performed in 27 (54%) and antegrade device closure was performed in 15 (38%) via RFV and 3 (6.6%) with mid-muscular and lower muscular defects via RIJ access. Device choice was based on VSD characteristics, with a size 1-2mm larger than the largest defect diameter on the RV side. ADO I devices (15 cases, 30%) were used for defects with a septal aneurysm, ADO II (27 cases, 52%) for smaller defects, and muscular VSD device for larger defects.   Device closure was successful in 45 patients (90%), 5 (12%) of which had minimal intra-device residual flow at discharge which had resolved by 1-month follow-up. There were no incidences of aortic or tricuspid regurgitation. There was 1 (2%) immediate device embolization. Unsuccessful attempts included device embolization of undersized ADOII, severe bradycardia during delivery sheath advancement via an AV loop, aortic regurgitation caused by ADOII disc, and poor device position, each of which resulted in conversion to surgical closure.   Of the devices used in this study, the authors concluded that the most suitable device for closure of VSDs which are not very large (>5mm) and perimembranous in location is ADOII because of its feasibility to deliver it via a retrograde approach without forming an AV loop, as well as its softer profile to limit the chance of injury to adjacent structures.   

Real-Time Ultrasound Guidance for Umbilical Venous Cannulation in Neonates With Congenital Heart Disease Benjamin W Kozyak, María V Fraga, Courtney E Juliano, Shazia Bhombal, David A Munson, Erik Brandsma, Jason Z Stoller, Ankit Jain, Russell Kesman, Malorie Meshkati, Caroline Y Noh, Aaron G Dewitt, Andrew T Costarino, David A Hehir, Alan M Groves. Pediatr Crit Care Med. 2022;23(5):e257-e266. doi: 10.1097/PCC.0000000000002919. Epub 2022 Mar 7. PMID: 35250003   Take Home Points: Ultrasound guidance, coupled with liver pressure, can markedly improve successful placement of umbilical venous catheters in neonates with congenital heart disease (CHD). Routine use and training of this point-of-care ultrasound technique may reduce x-ray imaging and spare central veins, which are essential in patients with complex CHD. Commentary from Dr. Milan Prsa (Switzerland, Europe), section editor of Congenital Heart Disease Interventions Journal Watch:   Umbilical venous access is routinely obtained in neonatal ICUs and is indispensable for optimal care of patients with complex congenital heart disease (CHD). However, successful placement of an umbilical venous catheter (UVC) at the inferior cavoatrial junction has been reported at only 50-75%. The authors describe and report on the success of their technique to rescue malpositioned UVCs.   Over a period of 26 months, 32 neonates with CHD underwent ultrasound-assisted UVC placement by experienced neonatologists across three centers, all after previous failed attempts at traditional, blind insertion. The technique used starts with imaging the trajectory the UVC will follow from the umbilical vein (UV) to the portal sinus, and then through a patent ductus venosus (DV) to the inferior cavoatrial junction. Patency of the DV is evaluated with color Doppler or injection of agitated saline. The catheter is then advanced under direct visualization to the portal sinus, where probe pressure on the liver distorts the portal sinus to enhance its alignment with the DV, allowing a straighter trajectory from the UV and preventing malposition of the catheter in the portal veins (Figure 1). With this technique, malpositioned UVCs were rescued in 23 of 32 patients (72%), including 18 of 24 patients (75%) on prostaglandin. None of the patients required other central venous access, and there were no catheter-associated complications or cases of portal vein thrombosis.     Figure 1. Effect of liver pressure on producing a straighter trajectory from the UV to the DV (*), avoiding malposition in the portal veins (# and arrows).   This multicenter case series demonstrates that use of point-of care ultrasound (POCUS) to rescue malpositioned UVCs has a high success rate in neonates with complex CHD. However, this was possible in large academic centers with providers who had significant prior experience with POCUS. Nevertheless, the potential benefits of preserving precious central veins and reducing radiation exposure in patients with complex CHD should serve to encourage providers in centers with POCUS capabilities to undergo formal training and implement this technique.   

Use of the Medtronic Microvascular Plug 7Q for transcatheter closure of large patent ductus arteriosus in infants weighing less than 2.5 kg. Nasef MA, Sullivan DO, Ng LY, Walsh KP, Oslizlok P, McCrossan B, Kenny D, Sathanandam S. Catheter Cardiovasc Interv. 2022 Apr;99(5):1545-1550. doi: 10.1002/ccd.30105. Epub 2022 Jan 30. PMID: 35094486   Take Home Points: The Medtronic Microvascular Plug (MVP-7Q) is device to consider for use in larger PDAs (4-7 mm) in small premature infants <2.5 kg with good acute success (91% procedural success) and excellent short term follow-up (no LPA, aortic obstruction and no residual shunt) in this limited population of patients. Favorable device characteristics include low profile, flexible delivery cable (and delivery through the diagnostic angled glide catheter. The MVP-7Q device is long (16 mm) which may limit its use in shorter tubular ducts, however the tapered ends and uncovered distal end of the device may allow for some device protrusion into the aorta and LPA without development of significant obstruction. Commentary from Dr. Wendy Whiteside (Ann Arbor, MI, USA), section editor of Congenital Heart Disease Interventions Journal Watch   In this multicenter retrospective review, Nasef et al describe their experience with the use of the Medtronic Microvascular Plug (MVP) 7Q for PDA closure in small premature infants <2.5 kg. While the Amplatzer Piccolo device is the only FDA approved device for PDA closure in preterm infants (>700 grams), there are still a subset of patients with large PDAs with minimum diameter >4 mm for whom Piccolo is too small. Additionally, there are some device/delivery system properties which may make the MVP-7Q an appealing choice for PDA closure in premature infants.   This study included 22 patients from two centers, Children’s Health Ireland at Crumlin and La Bonheur Children’s Hospital in Memphis, TN, with hemodynamically significant PDAs who were less than 2.5kg and had PDA closure attempted with the Medtronic MVP-7Q. The median age at time of procedure was 32 days (IQR 26-57 days) and median weight 1100 grams (IQR 960-1700 grams). MVP-7Q was chosen for PDAs measuring above 4 mm but less than 7 mm (median aortic dimension 5.1 mm, PA dimension 4.8 mm, and length 12 mm). Procedure duration, fluoroscopy time, and radiation dose were all low and on par with Piccolo procedures. Procedural details were also similar to that described with Piccolo, with vascular access exclusively in the femoral vein and retrograde access across the PDA using a 4 French angled glide catheter and Wholey guidewire. As the MVP-7Q can be delivered through the same 4 French catheter, no catheter exchange is necessary.   PDA occlusion was successful in 20/22 patients (91% procedural success). Unsuccessful procedures were 1) failed attempt to implant MVP-7Q via the IJ approach, and 2) significant LPA compression noted during intra-procedural TEE and angiography following device release and necessitating snare/retrieval of the device. There were no other procedural complications noted including vascular access complications, tricuspid valve injury, LPA or aortic stenosis. Post-procedural TTE demonstrated complete occlusion of the PDA in all except one patient, who had small residual shunt through the device which resolved by repeat echo at 7 day follow-up. Median follow-up time was 2.5 years (IQR 12 months-4.3 years) at which time all patients were alive and there was no LPA stenosis, aortic arch obstruction, or residual shunt observed.   Small infants with large PDAs are a difficult population of patients to treat with percutaneous devices. While the Amplatzer Piccolo device is an excellent device for PDA closure in premature infants, it does have some limitations including a stiff delivery system and recommended use in PDAs <4 mm in diameter. The Amplatzer Vascular Plug II (AVPII) can be used for some long tubular PDAs which size out of Piccolo, however it only comes in 2 mm (even number) increments and has a relatively stiff delivery cable which may distort the device. For patients with PDAs in the 4 mm-7 mm range, therefore, there are limited device options. The MVP-7Q is appealing due to its low profile and soft/flexible delivery cable. While the device is long (16 mm unconstrained length, it has an ovoid shape, with contact to the PDA wall over only 8 mm, and an uncovered distal end of the device measuring 4 mm. While this may mean the uncovered tapered distal device or tapered proximal end may extend into the aorta or LPA, respectively, there was minimal concern for LPA or aortic obstruction as a result of the device in immediate and short term follow-up. One additional disadvantage of the MVP-7Q is that it is radio-opaque with the exception of the two device ends, making it a difficult device to visualize during device positioning. Compression of the device can only be appreciated by increased length of the device.   While this study describes only a limited, small sample of patients, it does show feasibility and safety of the use of MVP-7Q for PDA closure in small premature infants. While additional study is necessary in a larger population of patients over a longer follow-up duration, MVP-7Q does provide an alternative device for large PDAs (between ~4-7 mm) in patients <2.5 kg with some nice device characteristics including a low profile, flexible delivery system.  

Prospective multicenter study of the breakable babystent for treatment of aortic coarctation in newborns and infants. Stiller B, Zartner P, Dähnert I, Haas NA, Schubert S, Kanaan M, Berger F, Ewert P, Schmoor C, Grohmann J. Catheter Cardiovasc Interv. 2022 Apr;99(5):1529-1537. doi: 10.1002/ccd.30133. Epub 2022 Feb 16. PMID: 35170186 Clinical Trial.   Take Home Points: The Osypka BabyStent is a 15mm long cobalt chromium stent, premounted on a 6mm balloon and inserted through a 4 French sheath. The stent can be expanded to 10-12mm and with further dilation the locking mechanism of the hook and eye connections opens allowing for further dilation without the need to fracture the stent. The stent was successfully implanted in all patients without access site complications. Commentary from Dr. Konstantin Averin (New York), catheterization section editor of Pediatric Cardiology Journal Watch: Balloon expandable stents (BES) are the mainstay of therapy for many forms of congenital heart disease. In smaller patients, BES use can be limited by the expansion potential of appropriate profile stents. The “holy grail” for congenital interventional cardiologist is a balloon expandable stent that has a low delivery profile, can be implanted at small diameters, and can easily be expanded to adult sizes. In this report, the authors describe the results of a prospective, interventional, open, single-arm, multicenter study from six sites in Germany from 9/2015 to 10/2018 using the breakable Osypka BabyStent (OBS) for treatment of coarctation of the aorta (CoA). OBS is a low profile, 15mm long cobalt-chromium stent, premounted on 6mm balloon and inserted via a 4Fr sheath over a 0.018” wire. The stent easily expands to 10-12mm and after this the locking mechanism of the hook and eye connections opens allowing for further dilation without the need to fracture the stent – see Figure below.   Inclusion criteria were BW > 1.8kg, age < 24 month at time of procedure and isolated aortic or aortic arch obstruction (meeting criteria for stent implant at time of catheterization) deemed high-risk for surgical intervention. Thirty-one patients were screened and subsequently underwent cardiac catheterization; 12 of these did not meet inclusion criteria (10 due to successful balloon dilation and 2 due to lack of consent) – this left 19 patients (median weight 5.6 kg [2.4-8.4] and age 112 days [7-539]). All stents were successfully implanted with the primary endpoint (inner lumen expansion by >50% of baseline diameter) achieved in 15/19 (79%). Most patients required reintervention at 12 months post-stent implant (2 surgical revision and 13 balloon dilation, with 4 requiring a second re-dilation). All patients were alive at 12 month follow up. The two patients requiring surgical revision were due to a post-stent aneurysm at a surgical suture line (implanted 13 days post-surgery) and 1 after stent implant allowed for myocardial recovery with residual gradient. There were no access complications.   The authors describe the successful use of a new stent design that facilitates stent therapy in infants in small children. While not adult capable, these stents convert the relatively chaotic and uncontrolled process of stent fracture into one that is controlled and likely carries less morbidity. Whether this stent proves to be the “holy grail” of stent therapy is not yet clear, but it is certainly an important step-forward in stent design for treatment of congenital heart disease.    

Distensibility of the ductus arteriosus in neonates and young infants undergoing transcatheter closure. Nagasawa K, Muneuchi J, Sugitani Y, Ezaki H, Doi H, Furuta T, Kobayashi M, Watanabe M.Heart Vessels. 2022 Mar;37(3):513-516. doi: 10.1007/s00380-021-01925-9. Epub 2021 Aug 18.PMID: 34406441 Take home points Forty one, term babies with PDA with Qp:Qs 1.53-3.13:1 were evaluated. Thirty-seven (93%) had successful closure. Three had device instability and one had device migration; these four were excluded from analysis. The authors did not further discuss these patients. The following devices were utilized/attempted: ADO (32), ADO-2 (1) and AVP-2 (8), all nitinol devices. Distensibility index, defined as ratio of device center diameter after device deployment to the diameter at the center of the ductus before PDA closure, was evaluated in these babies. Distensibility index measured in each baby with successful closure; the mean distensibility index was 1.28 Distensibility index was negatively correlated with age (r= -0.49) and weight (r= -0.53), p<0.01 for both The authors conclude that younger and smaller babies have a more distensible patent ductus, potentially putting those babies at higher risk for embolization         Commentary from Dr. Thomas Zellers (Dallas, USA), section editor of Congenital Heart Disease Interventions and ACHD Journal Watch:   Summary: Forty one babies, 68% female, with a mean gestational age of 38 weeks (37-39 weeks) were evaluated. Mean birth weight was 2.71 kg (2.4-3.03 kg). The mean weight at implant was 5.32 kg (range 4.33-6.93 kg); mean age at implant was 168 days (range 117-260 days). All patients underwent cardiac catheterization with the plan to implant a closure device. Thirty-seven (93%) were successfully implanted; 3 had unstable devices and one had device embolization but no further information was given about these four patients and they were excluded, likely because the distensibility index could not be calculated. The mean pulmonary arterial pressure was 28 (range 16-60 mmHg) and Qp:Qs was 2.19:1 (range 1.53-3.13). PDAs were categorized according to the Krischenko criteria: Type A = 29, Type B = 1, Type C = 8, Type D = 1 and Type E = 3. The mean diameters of the PDA at the PA size, center and aortic end were 3.2 (2.2=4.3) mm, 4.7 (3.6-5.7) mm and 7.7 (6.3-9.4) mm, respectively. Devices attempted or deployed were ADO-1 = 32, ADO-2 = 1, and AVP-2 = 8. After deployment, the CENTER of the device was measured and compared to the pre-implant CENTER diameter of the PDA and a distensibility index was calculated as a ratio of the measurement of the center of the device after implantation to the center of the PDA pre-implantation. The mean distensibility index for the population was calculated at 1.28. The distensibility index negatively correlated with age (r= -0.49) and weight (r= -0.53) with a p value < 0.01 for both. A few of the older (> 200 days) and larger (> 5 kg) patients actually had a distensibility index < 1. The authors concluded that the younger and lower weighted patients had a more distensible ductus. However, there are several limitations. It is a retrospective evaluation. The measurements of the CENTER of the device and ductus may not have always been correlated exactly as the devices may distort the PDA. The majority of the PDAs were closed with an ADO1, and the retention disc may be pulled fairly far into the ductus, making the center of the ductus more difficult to discern and measure accurately.    

Late Outcomes of Transcatheter Coarctation Intervention in Infants with Biventricular Anatomy. Kurtz JD, Rubio AE, Johnston TA, Morray BH, Jones TK. Pediatr Cardiol. 2022 Mar 10. doi: 10.1007/s00246-022-02865-5. Online ahead of print. PMID: 35274168   Take Home Points: Transcatheter balloon angioplasty and stent implantation are a safe and effective way to treat native and recurrent coarctation of the aorta in infants. There is a high rate of transcatheter and surgical re-intervention in this patient population, especially when stenting was performed. The development and approval of bioresorbable stents could drastically shift the management of coarctation of the aorta away from surgery if they are deliverable through small sheaths. Commentary from Dr. Ryan Romans (Kansas City, MO), section editor of Congenital Heart Disease Interventions Journal Watch: Coarctation of the aorta (CoA) is a discrete narrowing of the thoracic aorta typically just distal to the left subclavian artery. CoA is common, accounting for 5-8% of congenital heart disease (CHD). Surgical repair is the preferred approach in infants less than 12 months of age at most centers, though there is a recurrent CoA rate of 4-14% (Mery CM, Guzmán-Pruneda FA, Trost JG Jr, et al. Contemporary Results of Aortic Coarctation Repair Through Left Thoracotomy. Ann Thorac Surg 2015; 100:1039., Karamlou T, Bernasconi A, Jaeggi E, et al. Factors associated with arch reintervention and growth of the aortic arch after coarctation repair in neonates weighing less than 2.5 kg. J Thorac Cardiovasc Surg 2009; 137:1163.), with smaller size at time of repair a known risk factor. Alternatively, transcatheter balloon angioplasty and/or stent implantation have also been shown to achieve good short-term outcomes. In many centers, transcatheter treatments have been used in infants to delay surgery until patients are larger and in critically ill children with high surgical risk (such as impaired left ventricular function with relief of obstruction allowing for recovery of function). Aortic angioplasty has limited long term effectiveness and stent implantation mandates repeat procedures to enlarge the stent or surgery to remove the stent. Additionally, currently available stents that are implanted into infants cannot be made to adult size and need to be surgically excised or fractured with additional stent placement. No data exist on long term outcomes in infants treated with stenting.   A retrospective review was performed on all patients with biventricular circulation who underwent transcatheter intervention for CoA (native and recurrent) at Seattle Children’s Hospital from 2004-2020. There were 34 infants who were included in the analysis; 16 underwent stent implantation (angioplasty was attempted in 8 of these 16 with inadequate results). 31/34 procedures were performed via a femoral arterial approach. There were no baseline differences between the angioplasty and stent groups in patient demographics, procedure indication (LV dysfunction or gradient), whether the CoA was native or recurrent, or baseline peak-to-peak systolic gradient. Stent implantation led to a greater reduction in the gradient than angioplasty (27.6 ± 16.8 mmHg vs. 19.1 ± 10.4 mmHg) and lower residual gradient (5.6 ± 6.6 mmHg versus 11.9 ± 9.5 mmHg). The minimal luminal diameter was smaller in the stent group (2.0 ± 0.9 mm) than the angioplasty group (2.7 ±1.1 mm). The post-intervention to pre-intervention minimum aortic diameter ratio was larger in the stent group (2.8 ± 1.1 mm) than the angioplasty group (1.7 ± 0.6 mm). There were four (12%) vascular complications; 3 were loss of lower extremity pulse that were medically treated, and the other was an aortic wall injury requiring covered stent placement. The mean follow-up time was 8.1 ± 5.2 years for the stent group and 3.0 ± 3.6 years for the angioplasty group. Need for reintervention was earlier in the stent group (1.7 ± 3.1 years) than for the angioplasty group (2.7 ± 3.9 years), though this did not quite meet statistical significance. 12 patients ultimately required surgical reintervention (3/18 angioplasty, 9/16 stent).   This study shows that transcatheter intervention for CoA is safe and achieves accept relief of the obstruction in infants. This date is valuable as a previous study looking at outcomes of surgical repair of recurrent CoA in biventricular hearts had a serious adverse event rate of 28%. While angioplasty can achieve acceptable results in many patients, previous studies have shown a re-intervention rate of 17.9%. Stent implantation achieves superior immediate results but as previously discussed poses problems in getting the stented aorta to adult sized dimensions. In this cohort, more than 50% of patients who underwent stent implantation ultimately required surgical revision. While this is not ideal, it does allow for the surgical intervention to be delayed until the patient is older and larger or more medically stable (i.e., improved LV function). Advances in stent technology (bioresorbable stents, stents that can be implanted in infant sized aortas and expanded to adult size) could allow for a further shift in treatment of CoA away from surgery and towards less invasive transcatheter intervention.   Recurrent CoA in 3-month-old Stent imnplantation after failed angioplasty.   

Balloon-Expandable Cheatham-Platinum Stents Versus Self-Expandable Nitinol Stents in Coarctation of Aorta: A Randomized Controlled Trial. Sadeghipour P, Mohebbi B, Firouzi A, Khajali Z, Saedi S, Shafe O, Pouraliakbar HR, Alemzadeh-Ansari MJ, Shahdi S, Samiei N, Sadeghpour A, Babaei M, Ghadrdoost B, Afrooghe A, Rokni M, Dabbagh Ohadi MA, Hosseini Z, Abdi S, Maleki M, Bassiri HA, Haulon S, Moosavi J. JACC Cardiovasc Interv. 2022 Feb 14;15(3):308-317. doi: 10.1016/j.jcin.2021.11.025.PMID: 35144787   Take Home Points: In this small, single center, randomized controlled study, both balloon-expandable and self-expandable stents can be used for the treatment of native coarctation of the aorta in adults with good procedural success and low periprocedural complications. No significant differences were found between the two stent types in the acute periprocedural complications, stent performance, or short term (1-year) follow up. Additional study of these stent types, over a longer period of follow-up, will be required in order to fully understand whether the performance of these stents is in fact comparable over a longer period of time. Commentary from Dr. Wendy Whiteside (Ann Arbor, MI, USA), section editor of Congenital Heart Disease Interventions Journal Watch: In this article, Sadeghipour et al describe results of their single center randomized controlled study comparing the safety and efficacy of balloon-expandable versus self-expanding stents in native coarctation of the aorta. While BES are commonplace for treatment of coarctation, some unique benefits of SES (including ease and accuracy of deployment) may make their use more appealing.   The study evaluated 92 eligible adult patients with a median age of 30 years and with native coarctation of the aorta between 1/2017-12/2019. Primary outcome of the study was a composite of procedural and vascular complications. Secondary outcome included the incidence of aortic recoarctation, aortic aneurysm/pseudoaneurysm formation, and residual hypertension at 12-month follow-up. Only uncovered stents were used in this study, with patients randomized to receive a Cheatham-platinum balloon-expandable stent (BES) or an uncovered nitinol self-expanding stent (SES-- Optimed Sinus-XL stent). All cases were performed under mild sedation/local anesthesia. Femoral arterial and right radial access was obtained in all patients. Access was obtained using only fluoroscopic landmarks in all patients, and for consistency, all patients had femoral arterial access site upsized to a 12 French arterial sheath for the stent implantation. The CP stent was hand mounted on a BIB balloon, and temporary rapid ventricular pacing was utilized in the BES group. The authors state that if residual gradient exceeded 10 mmHg, balloon post-dilation was performed, however there was no breakdown of how frequently and which patients required this. Procedural and post-procedural anticoagulation was the same across all patients- heparin during the procedure, ASA/Plavix for 1 month, and ASA alone indefinitely.   The two groups were similar in baseline imaging and clinical characteristics. Procedural success was 100%, with reduction in gradient from mean of 62.2±16.4 mmHg in BES and 65.6±19 mmHg in the SES group to 1.5±3.2 mmHg in the BES and 1.4±4.2 mmHg in SES groups (p=0.52). The primary outcome, composite of periprocedural complications and vascular access complications, occurred in 6.5% of patients in the overall cohort (4.3% procedural and 2.2% vascular access) without a significant difference between groups. Primary outcome was observed in 5 patients (10.9%) in the BES group and 1 patient (2.2%) in the SES group (OR 0.18, p=0.20). Procedural complications included periprocedural stent migration, acute cerebrovascular accident, massive pericardial effusion, and aortic dissection. Vascular complications, including non-flow limiting femoral artery dissection, femoral artery pseudoaneurysm, and retroperitoneal hemorrhage occurred in 1.1% of the overall cohort (2 patients, 4.3% in the BES group and no patients in the SES group, p=0.49).   In regards to secondary outcomes, 5 patients (5.4%) had confirmed aortic recoarctation during the 1 year follow-up with no difference in incidence between groups (3 patients, 6.5% in the BES group and 2 patients, 4.3%, in the SES group; OR 0.65, CI 0.10-4.09, p=0.64). One of these patients required placement of an additional stent and all others received balloon angioplasty of existing stent alone. One re-dilation in the BES group was complicated by aortic pseudoaneurysm formation, subsequent treated with aortic stent graft implantation. Blood pressure control was achieved in 50% of patients, with no difference between groups.   While this single center study was small and underpowered, it does show that both approaches to treatment of native coarctation of the aorta in adults, with balloon expandable or self-expanding stents, is acutely successful, with low rates of periprocedural complications, and low rates of recoarctation at 1 year follow-up. Some limitations, however, include no data provided on stent post-dilation—one would suspect that the radial force of a SES alone may not be enough to expand the coarctation segment in some patients and therefore the SES group may have a higher rate of stent post-dilation in order to achieve successful (low stent gradient) stent implantation, however this is not discussed at all other than to say that stent dilation was performed when necessary. Some procedural techniques, including lack of ultrasound use for vascular access, use of rapid pacing for BES implantation, and no use of vascular closure device at the conclusion of the case, are techniques that may differ between centers and may have direct impact on some of the complications seen. Additionally, and of high importance, is that follow-up only occurred over 12 months, so the long term stent performance and complications are not known from this study. It would be very interesting to observe these patients for longer follow-up to determine future rates of stent fracture, recoarctation, aneurysm formation, and need for future transcatheter or surgical intervention in the cohort as a whole, and between groups. Additionally, the two stents used here represent only one example of the many options of stents within these two stent types (BES and SES), so limit the generalizability of these results across centers where different stents are available and are used.   

Transcatheter Closure of Peri-membranous Ventricular Septal Defect Using the Lifetech Konar-Multi Functional Occluder: Early to Midterm Results of the Indonesian Multicenter Study. Kuswiyanto RB, Gunawijaya E, Djer MM, Noormanto, Rahman MA, Murni IK, Sukardi R, Utamayasa A, Ardiansyah R, Nova R, Liliyanti S, Rahayuningsih SE, Anggriawan SL, Rahayuningsih TY, Koentartiwi D, Soewarniaty R, Yantie VK, Nugroho S, Hidayat T, Ontoseno T, Tobing TC, Ali M, Bashari MH, Yosy DS, Arafuri N, Hilmanto D, Yanuarso PB, Advani N, Sastroasmoro S, Putra ST.Glob Heart. 2022 Feb 24;17(1):15. doi: 10.5334/gh.1106. eCollection 2022.PMID: 35342698   Take Home Points: Transcatheter closure of perimembranous ventricular septal defects is routinely performed in resource limited countries. The Lifetech Konar Multi-Functional Occluder (Konar MF VSD Occluder) is safe and effective for the closure of pmVSDs. The device has characteristics that make it suitable for closing various types of pmVSDs. Commentary from Dr. Konstantin Averin (New York), catheterization section editor of Pediatric Cardiology Journal Watch: In this study Kuswiyanto et al describe a prospective multi-center study to assess the feasibility and efficacy of perimembranous ventricular septal defect (pmVSD) closure using the Lifetech Multifunctional Occluder (MFO, now rebranded as Lifetech MF VSD Occluder) (Figure below). While the initial experience with a purpose made pmVSD device in the early 2000s was disappointing due to an unacceptably high incidence of complete heart block, pmVSD closure has become relatively routine in resource limited countries using a variety of new devices, including the Lifetech MFO.   From January 2016 to December 2017 195 patients underwent pmVSD closure with the Lifetech MFO at 11 centers in Indonesia; 55 patients did not have complete data so were excluded as were 8 adult patients. Thus, the study cohort was comprised of 132 patients – median age 4.5 years (range 0.3-17.4) and median weight 14.8 kg (range 3.5-57.0). The inclusion criteria were reasonable. There was a high successful implantation rate during the first or second attempt (~98%) with 31% of implants performed retrograde while the rest were antegrade. Acute occlusion occurred in 68.2% of patients. There were 3 device embolization within 24 hours of device implant and no other significant pre-discharge complications (no 2/3rd degree heart block). Of 126 patients who were discharged with a device, 12-month follow up was available in all. There was complete occlusion in 99.2% with no evidence of 2nd or 3rd degree heart block. No patients had greater than mild aortic regurgitation and 4 patients had moderate tricuspid regurgitation (3 infants with large devices).   The authors should be congratulated on this contribution to the literature, again demonstrating that the Lifetech Konar MFO is effective in closing pmVSDs in a heterogenous group of patients (ranging in size from 3.5 to 57 kg). The Lifetech Konar MF has several characteristics which make it well suited for closing pmVSDs – it can be deployed both antegrade and prograde, has a relatively low profile, is soft and can articulate giving it the ability to conform to a given anatomy and minimize pressure on the myocardium/conduction tissue. As the experience in Asia (and other countries) increasingly demonstrates the effectiveness of this device, it may eventually become possible to offer this procedure to patients in North America.   

Reintervention and Survival After Transcatheter Pulmonary Valve Replacement. McElhinney DB, Zhang Y, Levi DS, Georgiev S, Biernacka EK, Goldstein BH, Shahanavaz S, Qureshi AM, Cabalka AK, Bauser-Heaton H, Torres AJ, Morray BH, Armstrong AK, Millan-Iturbe O, Peng LF, Aboulhosn JA, Rużyłło W, Berger F, Sondergaard L, Schranz D, Cheatham JP, Jones TK, Ewert P, Schubert S.   J Am Coll Cardiol. 2022 Jan 4;79(1):18-32. doi: 10.1016/j.jacc.2021.10.031. PMID: 34991785   Take Home Points: Survival and freedom from reintervention or surgery after transcatheter pulmonary valve replacement seem to be comparable to outcomes of surgical conduit/valve replacement. Longer duration of follow-up in large cohorts of patients is necessary to assess long-term outcomes more definitively. Commentary from Dr. Konstantin Averin (Edmonton), catheterization section editor of Pediatric Cardiology Journal Watch: It has been greater than 10 years since the Melody valve first received FDA approval under the Humanitarian Device Exemption. Since that time, trans-catheter pulmonary valve replacement (TPVR) has advanced greatly, and percutaneous treatment of post-operative pulmonary outflow tract obstruction is now considered standard of care for many patients with a conduit or bio-prosthetic valve. Questions still exist regarding longer term outcomes of TVPR. The authors assembled a large, international multicenter registry to describe time-related outcomes in patients undergoing TPVR.   In this report, McElhinney et al report on 2,476 patients who underwent TPVR from July 2005 to March 2020 at 15 centers. The cumulative follow-up was 8,475 patient years (median duration of follow up = 2.8 years; and 3.3 years in those with at least 30 days of post-implant follow up). A total of 95 patients (3.8%) were known to have died after TPVR (24 – heart failure, 12 – endocarditis, 36 – other, 16 – unreported, 7 – related to procedural complications). Of the 7 patients who had procedural mortality (0.3% of entire cohort) 3 were from coronary artery compression and 2 from conduit rupture. The estimated cumulative death at 8-years post TPVR was 8.9%. The Figure below summarizes outcomes for the cohort as a whole and stratified by age group. On multivariable analysis, age at TPVR, existence of a prosthetic valve in another position and an existing transvenous pacemaker or implantable cardioverter-defibrillator at the time of TVPR were associated with death.   The authors should be congratulated on assembling and reporting on the largest cohort of patients to have undergone TPVR. The main limitation of this study is the relatively short median duration of follow-up (2.8 years). The authors offer a rationale for why their findings should be considered robust but additional longer term follow up to assess and compare outcomes remains necessary. Nonetheless, this report reassures us that survival and freedom from reintervention after TPVR are generally comparable to those after surgical replacement.     

Long Term Outcomes After Melody Transcatheter Pulmonary Valve Replacement in the US Investigational Device Exemption Trial. Jones TK, McElhinney DB, Vincent JA, Hellenbrand WE, Cheatham JP, Berman DP, Zahn EM, Khan DM, Rhodes JF Jr, Weng S, Bergersen LJ. Circ Cardiovasc Interv. 2022 Jan;15(1):e010852. doi: 10.1161/CIRCINTERVENTIONS.121.010852. Epub 2021 Dec 21.PMID: 34930015    Commentary from Dr. Milan Prsa (Switzerland, Europe), section editor of Congenital Heart Disease Interventions Journal Watch   Take Home Points: In patients with dysfunctional right ventricular outflow tract conduits and bioprosthetic pulmonary valves, transcatheter pulmonary valve replacement with the Melody valve showed an estimated 10-year survival of 90% and an estimated 10-year freedom from reintervention of 60%, which is not inferior to surgical management. Implantation at a younger age in a smaller right ventricular outflow tract conduit or bioprosthetic pulmonary valve was a risk factor for reintervention. Endocarditis was the leading cause of death with the annualized rate of Melody valve-related endocarditis of 2.0% per patient-year. The Melody transcatheter pulmonary valve (TPV) has revolutionized the care of patients with dysfunctional right ventricular outflow tract (RVOT) conduits and bioprosthetic pulmonary valves (BPV), decreasing their lifetime burden of repeat surgery. However, data on long-term outcomes beyond 5 years after implant has been seriously lacking. The results of this 10-year follow-up in the US Investigational Device Exemption (IDE) study of the Melody valve are therefore a much-needed addition to the literature.   The trial included patients ≥5 years of age and ≥30 kg who had a dysfunctional RVOT conduit ≥16 mm in diameter or a stented BPV with internal diameter 18-22 mm at time of implant. Conduit or valve dysfunction was defined as moderate (3+) or severe (4+) pulmonary regurgitation (PR), or mean RVOT gradient >35 mmHg for NYHA class II, III, or IV, and severe (4+) PR with RV dilatation or dysfunction, or mean RVOT gradient >40 mmHg for NYHA class I.   149 patients were followed for a median of 8.4 years (5.4–10.1), with 102 patients having completed the 5-year follow-up assessment, and 58 patients having completed the 10-year follow-up assessment.   Estimated 10-year survival was 90% (79%–96%), with 5 of 11 deaths related to endocarditis. Estimated 10-year freedom from TPV dysfunction (RVOT reoperation, catheter reintervention on TPV, or ≥moderate PR and/or mean RVOT gradient >40 mm Hg) was 53% (40%–65%) and was significantly shorter in patients ≤21 years of age at implant (Figure 1).     Figure 1. Kaplan-Meier curves showing estimated freedom from mortality by age (A), overall freedom from TPV dysfunction (B), and freedom from TPV dysfunction by age (C).   Estimated 10-year reintervention-free survival was 55% (45%–63%), freedom from any TPV reintervention was 60% (47%–71%) and freedom from RVOT reoperation was 79% (67%–87%). On multivariable regression analysis, risk factors for reintervention were age ≤21 years, non-stented BPV/RVOT conduit, stenosis as primary indication for TPV replacement (TPVR), more prior open-heart surgeries and higher post-implant RV-pulmonary artery peak-to-peak gradient.   Concerningly, 28 patients (19%) had endocarditis during follow-up. At 10 years, estimated freedom from TPV-related endocarditis was 81% (69%–89%), with an annualized rate of 2.0% per patient-year, and estimated freedom from any endocarditis was 76% (63%–85%), with an annualized rate of 3.0% per patient-year.   Freedom from major stent fracture at 10 years was 84% (70%–92%), unchanged from the 85% (78%–91%) rate at 5 years. Other significant outcomes included mean RVOT gradient <20 mmHg, ≤3% of patients with >mild PR, and ≥75% of patients in NYHA class I (vs. 14% pre-TPVR) over the entire study period.   This extended trial fills an important knowledge gap as it reports on the longest median follow-up of TPVR with the Melody valve. It shows survival and freedom from reintervention rates similar to surgical pulmonary valve replacement with a RVOT conduit in a recent study with comparable median follow-up.1 Not surprisingly, it identifies TPVR in younger patients with a smaller RVOT conduit or BPV as a risk factor for reintervention. Finally, it establishes endocarditis as a serious concern and a main cause of mortality, being unfortunately underpowered to ascertain its risk factors.   Lewis, M.J., Malm, T., Hallbergson, A. et al. Long-Term Follow-Up of Right Ventricle to Pulmonary Artery Biologic Valved Conduits Used in Pediatric Congenital Heart Surgery. Pediatr Cardiol (2022). https://doi.org/10.1007/s00246-022-02956-3