2-Year Clinical and Echocardiography Follow-Up of Transcatheter Mitral Valve Replacement With the Transapical Intrepid System.
JACC Cardiovasc Interv
; 17(12): 1440-1451, 2024 Jun 24.
Article
in En
| MEDLINE
| ID: mdl-38639690
ABSTRACT
BACKGROUND:
Thirty-day outcomes with the investigational Intrepid transapical (TA) transcatheter mitral valve replacement (TMVR) system have previously demonstrated good technical success, but longer-term outcomes in larger cohorts need to be evaluated.OBJECTIVES:
The authors sought to evaluate the 2-year safety and performance of the Intrepid TA-TMVR system in patients with symptomatic, ≥moderate-severe mitral regurgitation (MR) and high surgical risk.METHODS:
Patient eligibility was determined by local heart teams and approved by a central screening committee. Clinical events were adjudicated by an independent clinical events committee. Echocardiography was evaluated by an independent core laboratory.RESULTS:
The cohort included 252 patients that were enrolled at 58 international sites before February 2021 as part of the global Pilot Study (n = 95) or APOLLO trial (primary cohort noneligible + TA roll-ins, n = 157). Mean age was 74.2 years, mean STS-PROM was 6.3%, 60.3% were male, and 80.6% were in NYHA functional class III/IV. Most presented with secondary MR (70.1%), and nearly all had ≥moderate-severe MR (98.4%). All-cause mortality was 13.1% (30-day), 27.3% (1-year), and 36.2% (2-year). The 30-day ≥major bleeding event rate was 22.3%. Heart failure rehospitalization was 9.6% (30-day) and 36.2% (2-year). At 2 years, >50% of patients were alive with improvement in NYHA functional class (82.1%, class I/II), and all patients with available echocardiograms had ≤mild MR.CONCLUSIONS:
This analysis represents the largest reported TA-TMVR experience with the longest follow-up in high-risk ≥moderate-severe MR patients. Early mortality and heart failure rehospitalizations were significant, exacerbated by early TA-related bleeding events; however, meaningful improvements in clinical outcomes and marked reductions in MR severity were observed through 2 years.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Severity of Illness Index
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Heart Valve Prosthesis
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Cardiac Catheterization
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Heart Valve Prosthesis Implantation
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Recovery of Function
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Mitral Valve
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Mitral Valve Insufficiency
Limits:
Aged
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Aged80
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Female
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Humans
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Male
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Middle aged
Language:
En
Journal:
JACC Cardiovasc Interv
Year:
2024
Document type:
Article