One-year Outcomes and Predictors of Mortality After MitraClip Therapy in Contemporary Clinical Practice: Results From the German Transcatheter Mitral Valve Interventions Registry

Miriam Puls; Edith Lubos; Peter Boekstegers; Ralph Stephan von Bardeleben; Taoufik Ouarrak; Christian Butter; Christine S. Zuern; Raffi Bekeredjian; Horst Sievert; Georg Nickenig; Holger Eggebrecht; Jochen Senges; Wolfgang Schillinger

Disclosures

Eur Heart J. 2016;37(8):703-712. 

In This Article

Limitations

First of all, the current data are reassuring that the results of percutaneous mitral valve repair with MitraClip seen in other registries are reproducible. Naturally, registries cannot replace randomized evidence and have the inherent limitation to be not completely controlled with the risk of under-reporting of events or complications. Although randomized trials are the foundation to establish evidence-based guidance in patient management, 'all-comer' registries like TRAMI serve an important complementary role by evaluating penetration and contemporary use of novel therapies in real life.

However, this study has several limitations. Because TRAMI was not industry-sponsored (which is also a strength of this registry), patient enrolment was on a voluntary basis, and no remuneration was paid. Therefore, the large range of patients included across centres probably reflects non-consecutive enrolment in several centres. All baseline and in-hospital data were site-reported. Moreover, echocardiographic data were not core-lab adjudicated and therefore of minor quality. Follow-up at 30 days and at 1 year was performed by telephone call and did therefore not include an echocardiography. Furthermore, regarding the entire cohort of 828 patients prospectively included in TRAMI, the 1-year follow-up was incomplete (90.5%) which could create a selection bias. To address this potential problem, Supplementary material online, Tables S2 and S3 http://eurheartj.oxfordjournals.org/content/suppl/2015/11/27/ehv627.DC1 comparing TRAMI patients with and without 1-year follow-up are presented.

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