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

EuroIntervention : Journal of EuroPCR in Collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
Nicolas DumonteilKeith D Dawkins

Abstract

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. 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). Careful attention to valve sizing and impla...Continue Reading

References

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Citations

Oct 16, 2018·Expert Review of Medical Devices·Amir SolomonicaRodrigo Bagur
Sep 21, 2017·EuroIntervention : Journal of EuroPCR in Collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology·Jan-Malte Sinning, Eberhard Grube
Nov 27, 2019·Current Cardiology Reports·Matthew E SeigermanSaif Anwaruddin
Oct 24, 2019·Journal of the American Heart Association·Christopher U MeduriMichael J Reardon
Jan 23, 2021·JACC. Cardiovascular Interventions·Stefan Toggweiler
Nov 17, 2020·Circulation Journal : Official Journal of the Japanese Circulation Society·Shigeru SaitoYoshiki Sawa
Mar 30, 2021·Journal of the American Heart Association·Justine M RavauxRoberto Lorusso
Aug 12, 2021·Europace : European Pacing, Arrhythmias, and Cardiac Electrophysiology : Journal of the Working Groups on Cardiac Pacing, Arrhythmias, and Cardiac Cellular Electrophysiology of the European Society of Cardiology·Justine M RavauxRoberto Lorusso

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