Abstract
Background: Valve-in-valve (VIV) treatment with transcatheter aortic valve replacement (TAVR) is a viable option for patients with failing aortic bioprosthetic valves. Optimal management of those with concomitant mitral regurgitation (MR) remains undetermined. Therefore, we sought to assess the implications of concomitant MR in patients undergoing VIV-TAVR. Methods and Results: The PARTNER 2 VIV registry enrolled patients with degenerated surgical aortic bioprosthesis at high risk for reoperation. Patients with core-laboratory echocardiographic assessment of MR were analyzed; severe MR was excluded. We compared patients with ≤mild MR versus moderate MR and assessed changes in MR severity and clinical outcomes. A total of 339 patients (89 initial registry, 250 continued access) underwent VIV procedures; mean age 79.0 ± 10.2 years, mean Society of Thoracic Surgeon score 8.9 ± 4.5%. At baseline, 228/339 (67.3%) had ≤mild MR and 111/339 (32.7%) had moderate MR. In paired analysis, there was significant improvement in ≥moderate MR from baseline to 30 days (32.6% vs. 14.5%, p <.0001 [n = 304]), and no significant change between 30 days and 1 year (13.4% vs. 12.1%, p =.56 [n = 224]) or 1 year and 2 years (11.0% vs. 10.4%, p =.81 [n = 182]). There was no difference in death or stroke between ≤mild MR and moderate MR at 30 days (4.0% vs. 7.2%, p =.20), 1 year (15.5% vs. 15.3%, p =.98) or 2 years (26.5% vs. 23.5%, p =.67). Conclusion: Moderate concomitant MR tends to improve with VIV-TAVR, and was not a predictor of long-term adverse outcomes in this cohort. In selected patients undergoing VIV-TAVR, it may be appropriate to conservatively manage concomitant MR. Clinical Trial Registration: ClinicalTrials.gov NCT# 03225001.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 981-986 |
| Number of pages | 6 |
| Journal | Catheterization and Cardiovascular Interventions |
| Volume | 96 |
| Issue number | 4 |
| DOIs | |
| State | Published - Oct 1 2020 |
Funding
Dr Murdoch is a consultant and proctor for Edwards Lifesciences. Dr Sathananthan is a consultant to Edwards Lifesciences and Medtronic. Ms. Alu has received consulting fees from Claret Medical and Cardiac Dimensions. Dr. Wood has received research funding and consulting fees from Edwards Lifesciences. Dr. Cheung has received consulting fees from Abbot Vascular, Medtronic, and Neovasc. Dr. Ye has received consulting fees from Edwards Lifesciences and JC Medical. Dr. Feldman has received research funding and consulting fees from Abbott, Boston Scientific, Edwards Lifesciences, and WL Gore, and became an employee of Edwards Lifesciences after this study was completed. Dr. Hahn has received consulting fees or speaking honoraria from 3Mensio, Abbott Vascular, Bayliss, Boston Scientific, Edwards Lifesciences, GE Healthcare, Medtronic, Navigate, Philips, and Siemens Healthineers. Dr. Jaber has echocardiography core lab contracts with Edwards Lifesciences, but receives no direct compensation. Dr. Mack serves on the PARTNER Executive Committee (Edwards, no direct compensation) and as Trial Co-PI of the COAPT Trial (Abbott, no direct compensation), and has received consulting fees from Gore. Dr. Malaisrie has received consulting fees from Edwards Lifesciences, Medtronic, and Abbott. Dr. Leon serves on the PARTNER Executive Committee (Edwards, no direct compensation) and has participated on medical advisory boards for Medtronic, Boston Scientific, Gore Medical, Meril Lifesciences, and Abbott. Dr. Webb has received research funding from, and is a consultant and proctor for, Edwards Lifesciences. The other authors have no relevant relationships with industry. The PARTNER 2 Valve-in-Valve Registry was funded by Edwards Lifesciences. Moderate concomitant MR tends to improve with VIV TAVR and was not a predictor of long-term adverse outcomes in this cohort. In selected patients undergoing VIV TAVR, it may be appropriate to conservatively manage concomitant MR. The PARTNER 2 Valve-in-Valve Registry was funded by Edwards Lifesciences. The PARTNER (Placement of Aortic Transcatheter Valves) 2 Valve-in-Valve registry was a multicenter study that prospectively enrolled patients with symptomatic degenerated aortic bioprosthetic surgical valves. An initial nested registry included 97 patients, and an additional 270 patients were subsequently enrolled in a continued access registry. Patients were assessed by a heart team and considered high risk if the risk of surgical mortality or major morbidity for reoperation exceeded 50%. Surgical bioprosthetic valve degeneration was defined as severe aortic stenosis with an effective orifice area (EOA) of <0.8 cm2 or an indexed EOA of <0.5 cm2/m2 and a mean gradient of >40 mmHg or peak velocity of >4 m/s, or severe aortic regurgitation. Mixed bioprosthetic failure was defined as at least moderate stenosis and regurgitation. Patients with concomitant mitral and tricuspid regurgitation were included, noting that severe MR was an exclusion. Other key exclusion criteria included greater than mild paravalvular regurgitation, bioprosthetic valve labeled size <21 mm, left ventricular ejection fraction <20%, or an expected life expectancy <2 years. Complete inclusion and exclusion criteria are outlined in Table S1. Patients underwent VIV TAVR with either a 23- or 26-mm SAPIEN XT transcatheter heart valve (THV) (Edwards Lifesciences Inc., Irvine, CA). This THV incorporated a balloon expandable cobalt chromium frame with bovine pericardial leaflets and a polyethylene terephthalate sealing cuff that covered the lower inner portion of the frame. Post procedure, 6 months of treatment with aspirin and clopidogrel was recommended. The PARTNER (Placement of Aortic Transcatheter Valves) 2 Valve-in-Valve registry was a multicenter study that prospectively enrolled patients with symptomatic degenerated aortic bioprosthetic surgical valves. An initial nested registry included 97 patients, and an additional 270 patients were subsequently enrolled in a continued access registry. Patients were assessed by a heart team and considered high risk if the risk of surgical mortality or major morbidity for reoperation exceeded 50%. Surgical bioprosthetic valve degeneration was defined as severe aortic stenosis with an effective orifice area (EOA) of <0.8 cm2 or an indexed EOA of <0.5 cm2/m2 and a mean gradient of >40 mmHg or peak velocity of >4 m/s, or severe aortic regurgitation. Mixed bioprosthetic failure was defined as at least moderate stenosis and regurgitation. Patients with concomitant mitral and tricuspid regurgitation were included, noting that severe MR was an exclusion. Other key exclusion criteria included greater than mild paravalvular regurgitation, bioprosthetic valve labeled size <21 mm, left ventricular ejection fraction <20%, or an expected life expectancy <2 years. Complete inclusion and exclusion criteria are outlined in Table S1. Patients underwent VIV TAVR with either a 23- or 26-mm SAPIEN XT transcatheter heart valve (THV) (Edwards Lifesciences Inc., Irvine, CA). This THV incorporated a balloon expandable cobalt chromium frame with bovine pericardial leaflets and a polyethylene terephthalate sealing cuff that covered the lower inner portion of the frame. Post procedure, 6 months of treatment with aspirin and clopidogrel was recommended. Patients had serial echocardiograms at baseline, within 24 hr of discharge, at 30-day, 1-year, and 2-year follow-up. All echocardiograms were independently assessed by a core laboratory. Mitral regurgitation severity was determined as recommended by the American Society of Echocardiography. MR severity was reported for each echocardiogram using a 5-tier reporting model (none, trivial, mild, moderate, or severe mitral regurgitation). The primary endpoint was a composite of all-cause mortality and stroke at 30-day, 1-year, and 2-year follow-up. Secondary endpoints were cardiovascular death, and improvement in MR severity at 30 days, 1 year and 2 years. Additional endpoints were the predictive value of baseline left ventricular dysfunction (LVEF ?40%), right ventricular dysfunction, tricuspid regurgitation, and the mechanism of bioprosthetic aortic valve failure on MR improvement at 30 days. Endpoints are defined as per the Valve Academic Research Consortium-2 criteria. Clinical events were adjudicated by a clinical event committee and all adverse events were reviewed by a data and safety monitoring board. The study protocol was approved by the institutional review board at each participating site, and all patients provided written informed consent. Categorical variables were reported as percentages and compared using the chi-square or Fisher's exact test, where appropriate. Continuous variables were reported as mean ? SD and compared using Student's t test or Wilcoxon rank-sum test where appropriate. Kaplan?Meier failure estimates reflect time-to-event outcomes and were compared by the log-rank test. The improvements within the same patient through follow-up period were examined by McNemar's test. Due to the crossing-over of 2-year KM curves, instead of hazard ratios from cox proportional models, odds ratios estimated from logistic regression models with log(event time) as offset variable were reported with/without the interactions between moderate/severe MR and TR or LV dysfunction. Adjusted comparisons on 2-year clinical outcomes were performed using multivariate logistic regression with log (event time) as offset variable. The covariates used for adjustments were: sex, Society of Thoracic Surgeon (STS) score, pulmonary hypertension, atrial fibrillation, and permanent pacemaker. The effects of mechanism of bioprosthetic valve failure and baseline right ventricular dysfunction on 30-day improvement were assessed by logistic regressions. All tests were two-sided, and p-values <0.05 were considered statistically significant. Statistical analyses were performed using SAS version 9.4 software (SAS Institute Inc., Cary, North Carolina). The PARTNER 2 Valve‐in‐Valve Registry was funded by Edwards Lifesciences.
ASJC Scopus subject areas
- Cardiology and Cardiovascular Medicine
- Radiology Nuclear Medicine and imaging