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“One-Stop Shop”: safety of combining transcatheter aortic valve replacement and left atrial appendage occlusion


Attinger-Toller, Adrian; Maisano, Francesco; Senn, Oliver; Taramasso, Maurizio; Shakir, Samera; Possner, Mathias; Gloekler, Steffen; Windecker, Stephan; Stortecky, Stefan; Lüscher, Thomas F; Meier, Bernhard; Nietlispach, Fabian (2016). “One-Stop Shop”: safety of combining transcatheter aortic valve replacement and left atrial appendage occlusion. JACC. Cardiovascular interventions, 9(14):1487-1495.

Abstract

OBJECTIVES: The aim of this study was to investigate the safety and efficacy of combining transcatheter valve replacement (TAVR) and left atrial appendage occlusion (LAAO) versus TAVR alone. BACKGROUND: Patients with severe aortic stenosis and atrial fibrillation undergoing TAVR are at increased risk for stroke and bleeding complications. METHODS: A cohort of 52 patients undergoing concomitant TAVR and LAAO were compared with 52 patients undergoing isolated TAVR. A primary safety endpoint at 30 days, a clinical efficacy endpoint from day 30 to last follow-up, and an LAAO efficacy endpoint from the first post-interventional day to the last follow-up were chosen. RESULTS: The mean age of the study population was 85 ± 5 years. The mean CHA2DS2-VASc score and HAS-BLED score were 3.9 ± 1.1 and 2.6 ± 0.9, respectively. The mean Society of Thoracic Surgeons score was 7.8 ± 5.5. The median follow-up duration of the study population was 9.4 months (range 0 to 48 months). The primary safety endpoint occurred in 10 patients in the concomitant group and in 7 patients in the isolated TAVR group (19% vs. 14%; 95% confidence interval: 0.59 to 4.06). The clinical and LAAO efficacy endpoints were achieved in 81 (79%) (75% vs. 82%; 95% confidence interval: 0.49 to 2.92) and 75 (73%) patients (69% vs. 76%; 95% confidence interval: 0.54 to 2.51), respectively. CONCLUSIONS: This pilot study shows that concomitant TAVR and LAAO is feasible and seems to be safe among patients with severe aortic stenosis and atrial fibrillation. Larger trials and longer follow-up are needed to confirm the safety and efficacy of such an approach.

Abstract

OBJECTIVES: The aim of this study was to investigate the safety and efficacy of combining transcatheter valve replacement (TAVR) and left atrial appendage occlusion (LAAO) versus TAVR alone. BACKGROUND: Patients with severe aortic stenosis and atrial fibrillation undergoing TAVR are at increased risk for stroke and bleeding complications. METHODS: A cohort of 52 patients undergoing concomitant TAVR and LAAO were compared with 52 patients undergoing isolated TAVR. A primary safety endpoint at 30 days, a clinical efficacy endpoint from day 30 to last follow-up, and an LAAO efficacy endpoint from the first post-interventional day to the last follow-up were chosen. RESULTS: The mean age of the study population was 85 ± 5 years. The mean CHA2DS2-VASc score and HAS-BLED score were 3.9 ± 1.1 and 2.6 ± 0.9, respectively. The mean Society of Thoracic Surgeons score was 7.8 ± 5.5. The median follow-up duration of the study population was 9.4 months (range 0 to 48 months). The primary safety endpoint occurred in 10 patients in the concomitant group and in 7 patients in the isolated TAVR group (19% vs. 14%; 95% confidence interval: 0.59 to 4.06). The clinical and LAAO efficacy endpoints were achieved in 81 (79%) (75% vs. 82%; 95% confidence interval: 0.49 to 2.92) and 75 (73%) patients (69% vs. 76%; 95% confidence interval: 0.54 to 2.51), respectively. CONCLUSIONS: This pilot study shows that concomitant TAVR and LAAO is feasible and seems to be safe among patients with severe aortic stenosis and atrial fibrillation. Larger trials and longer follow-up are needed to confirm the safety and efficacy of such an approach.

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Item Type:Journal Article, refereed, original work
Communities & Collections:04 Faculty of Medicine > University Hospital Zurich > Clinic for Cardiology
04 Faculty of Medicine > University Hospital Zurich > Institute of General Practice
Dewey Decimal Classification:610 Medicine & health
Language:English
Date:2016
Deposited On:04 Aug 2016 12:54
Last Modified:12 Oct 2017 16:09
Publisher:Elsevier
ISSN:1876-7605
Publisher DOI:https://doi.org/10.1016/j.jcin.2016.04.038
PubMed ID:27478117

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