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October 15, 2014European Journal of Heart Failure36 citations

Clinical Outcome of Critically Ill, not Fully Recompensated, Patients Undergoing MitraClip Therapy

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VRVolker RudolphMHMichael HuntgeburthRBRalph Stephan von Bardeleben

Key Result

MitraClip therapy in critically ill NYHA class IV patients was associated with higher 30-day mortality compared to NYHA class III and I/II patients (8.0% vs. 3.2% vs. 4.8%; P<0.05).

Study Design

Type

Observational (n=803)

Multicenter

Yes

Structured PICO

Does MitraClip implantation improve 30-day outcomes and symptoms in critically ill, not fully recompensated patients (NYHA IV) compared to less symptomatic patients?

P
Population
803 patients undergoing MitraClip implantation from the German Mitral Valve Registry, stratified by NYHA functional class, followed for 30 days.
E
Exposure
MitraClip implantation
C
Comparator
Patients in lower NYHA functional classes (NYHA III and NYHA I/II) undergoing the same procedure
O
Outcome
Procedural and 30-day outcomes (including mortality, rehospitalization, and NYHA functional class)hard clinical

MitraClip therapy in critically ill, NYHA IV patients is feasible and provides significant symptomatic improvement, but is associated with a higher 30-day mortality compared to less symptomatic patients.

Main Result

p-value: p=<0.05

Abstract

AIMS: As periprocedural risk is low, MitraClip implantation is often performed in critically ill, not fully recompensated patients, who are in NYHA functional class IV at the time of the procedure, to accelerate convalescence. We herein sought to evaluate the procedural and 30-day outcome of this patient group. METHODS AND RESULTS: A total of 803 patients undergoing MitraClip implantation were included in the German Mitral Valve Registry, and 30-day outcomes were prospectively assessed. Patients were separated based on NYHA functional class (NYHA IV (n = 143), III (n = 572), and I/II (n = 88). No difference was noted in co-morbities and echocardiographic parameters of LV function between groups. However, parameters of severity of mitral regurgitation (MR) were higher in NYHA IV patients. High procedural success rates and low residual MR grades at discharge were observed throughout all groups. In-hospital major adverse cardiac events were similar between groups. Importantly, 30-day mortality (8.0% vs. 3.2% vs. 4.8%; P < 0.05) was significantly higher in NYHA IV patients, whereas rehospitalization did not differ between groups. At 30 days, 47.6% of NYHA IV patients were still in NYHA class III or IV compared with 32.5% and 14.8% in the other groups (P < 0.05), although NYHA functional class decreased in 69% of patients. Quality of life, which was very poor at baseline, showed an overall improvement in NYHA IV patients after 30 days, with, for example, a reduction of bed-ridden patients from 19.6% to 3.3%. CONCLUSION: MitraClip therapy is feasible and safe even in critically ill, not fully recompensated patients and leads to symptomatic improvement in over two-thirds of these patients; however, it is associated with an elevated 30-day mortality.

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Cite This Study

Rudolph et al. (2014) conducted an observational in Mitral regurgitation (n=803). MitraClip therapy in NYHA class IV patients vs. MitraClip therapy in NYHA class I-III patients was evaluated on 30-day mortality (p=<0.05). MitraClip therapy in critically ill NYHA class IV patients was associated with higher 30-day mortality compared to NYHA class III and I/II patients (8.0% vs. 3.2% vs. 4.8%; P<0.05).

synapsesocial.com/papers/6a503a67a1cf396479ce9ed9https://doi.org/10.1002/ejhf.169
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