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08.05.2017 | Original Paper | Ausgabe 10/2017

Clinical Research in Cardiology 10/2017

Insights on mid-term TAVR performance: 3-year clinical and echocardiographic results from the CoreValve ADVANCE study

Zeitschrift:
Clinical Research in Cardiology > Ausgabe 10/2017
Autoren:
Sabine Bleiziffer, Johan Bosmans, Stephen Brecker, Ulrich Gerckens, Peter Wenaweser, Corrado Tamburino, Axel Linke, For the ADVANCE Study Investigators
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1007/​s00392-017-1120-3) contains supplementary material, which is available to authorized users.
The original version of this article was revised: The sentence in the Discussion describing the new pacemaker rate was incorrect. The correct version of the sentence is: The new pacemaker rate at 3 years of 31.4% is slightly higher than the 28% reported in the CoreValve US Pivotal High Risk Trial [8], and considerably higher than that reported with balloon-expanding devices [9,10].
In the Limitations, the sentence describing echocardiographic follow-up was incorrect. The correct sentence is: Echocardiographic compliance was 67%, as reported in the Results section.
An erratum to this article is available at https://​doi.​org/​10.​1007/​s00392-017-1124-z.

Abstract

Background

Extensive evidence relating to transcatheter aortic valve replacement (TAVR) has accumulated in recent years, but mid-term outcomes are less reported. We investigated 996 patients after implantation of the CoreValve prosthesis for severe aortic stenosis in a real-world setting.

Objective

To report clinical and echocardiographic 3-year results from the ADVANCE study.

Methods

ADVANCE is a prospective, multicenter, fully monitored, nonrandomized clinical study. This analysis assessed valve-related events, predictors of early and mid-term mortality after TAVR, and systolic and diastolic prosthesis performance over 3 years.

Results

Three years after TAVR, the rate of major adverse cardiac/cerebrovascular events was 38.5%. All-cause mortality was 33.7%; cardiovascular mortality, 22.3%; VARC-1 stroke, 6.5%; and New York Heart Association class III/IV, 19.5%. Mean effective orifice area was consistently 1.7 cm2 from discharge to 3 years, and average mean aortic valve gradient remained ≤10 mmHg. At 3 years, 12.6% of patients had moderate and none had severe paravalvular regurgitation. Multivariable analysis identified Society of Thoracic Surgeons (STS) score, device migration, prior atrial fibrillation, and major vascular complication as predictors of early mortality. Predictors of mid-term mortality included male gender, STS score, history of chronic obstructive pulmonary disease, history of cancer, stroke, life-threatening/disabling or major bleeding, and valve deterioration.

Conclusions

Our 3-year data demonstrate significant hemodynamic benefits and durable symptom relief after CoreValve prosthesis implantation. Postprocedural patient management should be carefully considered, since postprocedural valve-related events were identified as independent predictors of mid-term mortality.

Trial registration

ClinicalTrials.gov, NCT01074658.

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Zusatzmaterial
Supplementary material 1 (DOCX 174 kb)
392_2017_1120_MOESM1_ESM.docx
Literatur
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