Congenital Heart Interventions

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