"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; Glökler, 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), pp. 1487-1495. Elsevier 10.1016/j.jcin.2016.04.038

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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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