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.