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.