Long-term outcome, survival and predictors of mortality after MitraClip therapy: Results from the German Transcatheter Mitral Valve Interventions (TRAMI) registry☆
Introduction
Recently, the 5-year results of Endovascular Valve Edge-to-Edge Repair II Study (EVEREST II) have been published, demonstrating lasting durability and comparable overall mortality rates in patients treated by MitraClip (Abbott Vascular, Menlo Park, California) in contrast to open-heart surgery [1]. Translating these results into daily routine remains challenging since characteristics of patients characteristics enrolled into EVEREST II differ tremendously compared to real-life cohorts, especially in terms of patient age, co-morbidities, left ventricular (LV) function and mitral regurgitation (MR) aetiology [[2], [3], [4]].
The industry-independent, post-market Transcatheter Mitral Valve Interventions (TRAMI) registry, exclusively enrolled patients suffering from relevant MR considered inoperable and represents the largest real-life cohort. The 1-year follow-up has indicated significant clinical improvements and identified procedural failure as the strongest predictor of 1-year mortality [5].
Yet, except for EVEREST II, reliable data from randomized controlled trials (RCT) is lacking and long-term outcomes of patients undergoing MitraClip implantation are scarce. So far, larger European multicentre cohorts like the ACCESS-EU or the Pilot European Sentinel registries have only published 1-year results [4,6].
This study analyses long-term outcome after MitraClip implantation in the TRAMI registry, focusing on mortality rates and predictors of mortality and combined endpoints including cardiac rehospitalization and reintervention rates.
Section snippets
Transcatheter Mitral Valve Interventions registry
Established in 2010, the aim of the industry-independent TRAMI registry was to assess safety and patient outcomes after catheter-based mitral valve (MV) interventions. Further details about the registry and initial results have been published earlier [7].
The present analysis includes only prospectively enrolled patients treated by MitraClip implantation between 08/2010 until 07/2013. Out of 21 treatment centres and n = 828 patients, the following analysis included 799 patients prospectively
Baseline characteristics, procedural and in-hospital outcomes
Out of 799 patients enrolled (75.3 ± 8.6 years, male gender: 60.7%, EuroSCORE 23.7% ± 16.0, STS score 8.5% ± 7.5), FMR was the dominating aetiology (n = 495/714, 69.3%, Table 1).
Overall, there was a high burden of co-morbidities including relevant cardiac (coronary artery disease [78.5%], history of myocardial infarction [27.8%] or previous cardiac surgery [44.6%]) and non-cardiac (chronic kidney disease [CKD, 42.7%], diabetes mellitus [31.4%], chronic obstructive pulmonary disease [COPD,
Discussion
The TRAMI registry represents the largest cohort of real-world patients treated by MitraClip implantation. This study reports the long-term results of the prospective section with the following findings:
- (1)
relevant functional improvements and low MV reintervention rates were pertained over the entire follow-up period while estimated mortality rates exceed >50% at 4-year follow-up.
- (2)
the strongest predictor for long-term mortality proofed to be previous aortic valve implantation (followed by NYHA
Funding
The TRAMI registry has been supported by proprietary means of IHF. Additional funding is provided by “Deutsche Herzstiftung” and a grant from Abbott Vascular.
Conflict of interest
Authors US and WS are members of the advisory board of Abbott, whereas PB and HI have received proctor fees from Abbott. Furthermore, research grants (RSvB, EL), consulting fees (HS), speakers honoria (US, RSvB, HS, BP, CB, WS, EL) and travel expenses (DK, US, HS, EL) were disbursed by Abbott. All other authors report no conflicts of interest.
References (13)
- et al.
Randomized comparison of percutaneous repair and surgery for mitral regurgitation: 5-year results of EVEREST II
J. Am. Coll. Cardiol.
(2015) - et al.
Percutaneous mitral valve interventions in the real world
J. Am. Coll. Cardiol.
(2013) - et al.
Percutaneous mitral valve edge-to-edge repair
J. Am. Coll. Cardiol.
(2014) - et al.
Percutaneous mitral valve interventions in the real world: early and 1-year results from the ACCESS-EU, a prospective, multicenter, nonrandomized post-approval study of the MitraClip therapy in Europe
J. Am. Coll. Cardiol.
(2013) - et al.
Outcomes with transcatheter mitral valve repair in the United States: an STS/ACC TVT registry report
J. Am. Coll. Cardiol.
(2017) - et al.
Progression of aortic stenosis in 394 patients: relation to changes in myocardial and mitral valve dysfunction
J. Am. Coll. Cardiol.
(1995)
Cited by (70)
Percutaneous Mitral Valve Repair for Secondary Mitral Regurgitation: A Systematic Review and Meta-Analysis
2023, American Journal of Cardiology1-Year Outcomes With a Fourth-Generation Mitral TEER Device: Maturity Comes With Experience
2023, JACC: Cardiovascular InterventionsHeart Failure and Secondary Mitral Regurgitation: A Contemporary Review
2023, Journal of the Society for Cardiovascular Angiography and InterventionsRestoration of Life Expectancy After Transcatheter Edge-to-Edge Mitral Valve Repair
2023, JACC: Cardiovascular InterventionsCerebrovascular Events After Transcatheter Edge-to-Edge Repair and Guideline-Directed Medical Therapy in the COAPT Trial
2023, JACC: Cardiovascular InterventionsIntraprocedural Residual Mitral Regurgitation and Survival After Transcatheter Edge-to-Edge Repair: Prospective German Multicenter Registry (MITRA-PRO)
2023, JACC: Cardiovascular Interventions
- ☆
All authors take responsibility for all aspects of the reliability and freedom from bias of the data presented and their discussed interpretation.