EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2017
Insights into the need for permanent pacemaker following implantation of the repositionable LOTUS valve for transcatheter aortic valve replacement in 250 patients: results from the REPRISE II trial with extended cohort.
Клиническое исследованиеСтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Dumonteil Nicolas, Meredith Ian T, Blackman Daniel J, Tchétché Didier, Hildick-Smith David, Spence Mark S, Walters Darren L, Harnek Jan, Worthley Stephen G, Rioufol Gilles, Lefèvre Thierry, Modine Thomas, Van Mieghem Nicolas, Houle Vicki M, Allocco Dominic J, Dawkins Keith D
Аннотация
AIMS: This analysis aimed to evaluate the incidence and predictors of the need for permanent pacemaker (PPM) implantation following implantation of the repositionable and fully retrievable LOTUS Aortic Valve Replacement System.
METHODS AND RESULTS: The prospective, single-arm, multicentre REPRISE II study with extended cohort enrolled 250 symptomatic, high surgical risk patients with severe aortic stenosis for transfemoral transcatheter aortic valve implantation (TAVI) with a 23 mm or 27 mm LOTUS valve. Echocardiography, computed tomography, and electrocardiography data were evaluated by independent core labs. Post TAVI, 32.0% (72/225) of pacemaker-naïve patients underwent new PPM implantation at 30 days. Most (59/72, 82%) patients were implanted for third-degree atrioventricular block, and >10% overstretch of the LVOT by area was observed in 59.7% (43/72) of PPM patients. Significant independent predictors of PPM at 30 days included baseline RBBB (odds ratio [OR] 12.7, 95% CI: 4.5, 36.2; p<0.001) and LVOT overstretch >10% (OR 3.4, 95% CI: 1.7, 6.7; p<0.001). There was a trend towards a lower 30-day PPM rate in patients with a shallower (≤5 mm) implant depth (23.9% ≤5 mm vs. 36.9% >5 mm depth from LCS; p=0.06).
CONCLUSIONS: Careful attention to valve sizing and implant depth may help to reduce the rate of PPM with the LOTUS valve.
METHODS AND RESULTS: The prospective, single-arm, multicentre REPRISE II study with extended cohort enrolled 250 symptomatic, high surgical risk patients with severe aortic stenosis for transfemoral transcatheter aortic valve implantation (TAVI) with a 23 mm or 27 mm LOTUS valve. Echocardiography, computed tomography, and electrocardiography data were evaluated by independent core labs. Post TAVI, 32.0% (72/225) of pacemaker-naïve patients underwent new PPM implantation at 30 days. Most (59/72, 82%) patients were implanted for third-degree atrioventricular block, and >10% overstretch of the LVOT by area was observed in 59.7% (43/72) of PPM patients. Significant independent predictors of PPM at 30 days included baseline RBBB (odds ratio [OR] 12.7, 95% CI: 4.5, 36.2; p<0.001) and LVOT overstretch >10% (OR 3.4, 95% CI: 1.7, 6.7; p<0.001). There was a trend towards a lower 30-day PPM rate in patients with a shallower (≤5 mm) implant depth (23.9% ≤5 mm vs. 36.9% >5 mm depth from LCS; p=0.06).
CONCLUSIONS: Careful attention to valve sizing and implant depth may help to reduce the rate of PPM with the LOTUS valve.