Elsevier

International Journal of Cardiology

Volume 277, 15 February 2019, Pages 35-41
International Journal of Cardiology

Long-term outcome, survival and predictors of mortality after MitraClip therapy: Results from the German Transcatheter Mitral Valve Interventions (TRAMI) registry

https://doi.org/10.1016/j.ijcard.2018.08.023Get rights and content

Highlights

  • Long-term outcome was analyzed in the German Transcatheter Mitral Valve Interventions (TRAMI) registry comprising 799 patients treated at 20 centers in Germany.

  • This study demonstrated relevant clinical improvements and low reintervention rates, yet mortality rates exceeding 50% at 4-year follow-up.

  • To further understand the prognostic potential of MitraClip therapy, reliable evidence of the ongoing RCTs in FMR patients is urgently needed.

Abstract

Background

MitraClip therapy is increasingly used in patients deemed inoperable to treat severe mitral regurgitation (MR), but long-tern data is scarce.

Aims

The multicentre, industry-independent German Transcatheter Mitral Valve Interventions (TRAMI) registry comprises the largest prospectively enrolled cohort of patients treated by MitraClip therapy. The current analysis is focusing on long-term mortality rates, cardiac rehospitalization and reintervention.

Methods and results

Long-term follow-up (median time 1037 days) in the TRAMI registry was available for 722 patients treated at 20 German centres. Improvements in New York Heart Association (NYHA) functional class (I/II long-term: 65% vs. 1-year follow-up: 63.3%) and self-rated health-status (EuroQuol visual analogue scale [EQ VAS] long-term: 60 [50–70] vs. 1-year follow-up: 60 [50; 70]) were pertained over time.

Estimated mortality rates by Kaplan-Meier method were 19.7% for 1-year, 31.9% for 2-year and 53.1% for 4-year follow-up without differences found for MR aetiology. Multivariable Cox-regression analysis identified previous aortic valve implantation (hazard ratio [HR] = 2.21; p < 0.0001), NYHA class IV (HR = 1.78; p < 0.001), prior cardiac decompensation (HR = 1.63; p < 0.001), creatinine > 1.5 mg/dl (HR = 1.63; p < 0.0001) and left ventricular ejection fraction < 30% (HR = 1.60; p < 0.001) as most predictive for long-term mortality.

Conclusions

Long-term outcome in the TRAMI registry confirmed lasting clinical improvements and low intervention rates. Long-term mortality was strongly influenced by cardiac and non-cardiac co-morbidities and was found comparable for both MR aetiologies.

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.

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All authors take responsibility for all aspects of the reliability and freedom from bias of the data presented and their discussed interpretation.

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