Ferdinand Vogt1, Marco Moscarelli2, Anna Nicoletti3, Renato Gregorini3, Francesco Pollari4, Jurji M Kalisnik5, Steffen Pfeiffer6, Theodor Fischlein6, Giuseppe Santarpino7. 1. Department of Cardiac Surgery, Paracelsus Medical University, Nuremberg, Germany. Electronic address: ferdinand.vogt@klinikum-nuernberg.de. 2. Department of Cardiac Surgery, Anthea Hospital, GVM Care & Research, Bari, Italy. 3. Department of Cardiac Surgery, Città di Lecce Hospital, GVM Care & Research, Lecce, Italy. 4. Department of Cardiac Surgery, Paracelsus Medical University, Nuremberg, Germany; PhD Program in Angio-Cardio-Thoracic Pathophysiology and Imaging, Sapienza University of Rome, Rome, Italy. 5. Department of Cardiac Surgery, Paracelsus Medical University, Nuremberg, Germany; Department of Cardiovascular Surgery, University Medical Centre, Ljubljana, Slovenia. 6. Department of Cardiac Surgery, Paracelsus Medical University, Nuremberg, Germany. 7. Department of Cardiac Surgery, Città di Lecce Hospital, GVM Care & Research, Lecce, Italy; Paracelsus Medical University, Nuremberg, Germany.
Abstract
BACKGROUND: Several studies reported high rates of postoperative permanent pacemaker (PPM) implantation, which has been described as the "Achilles' heel" of sutureless aortic valve replacement (AVR). METHODS: From July 2010 to December 2017, 3,158 patients with symptomatic, severe aortic valve stenosis were referred to the Department of Cardiac Surgery (Klinikum Nürnberg - Paraclesus Medical University, Nuremberg, Germany), and 512 received a Perceval sutureless bioprosthesis (LivaNova PLC, London, United Kingdom). Thirty-nine patients who had been discharged with concomitant PPM implantation were reevaluated. RESULTS: After a cumulative follow-up of 1,534 months (100% complete, median 50 months, interquartile range 30 months, maximum 76 months, minimum 3 months), a total of 22 patients were still pacemaker dependent. Kaplan-Meier analysis showed pacemaker-dependent rhythm in 92.0%, 80.0%, 49.4%, and 32.3% of patients at 1, 2, 4, and 5 years, respectively. At Cox regression analysis, pressure during valve deployment (hazard ratio, 79.41; p = 0.0003) and "late-onset" atrioventricular block were found to be independent predictors of sinus rhythm restoration (hazard ratio, 0.16; p = 0.0061). Log-rank test showed significantly lower pacemaker dependency rates in patients with "low-pressure" prosthesis implantation (p < 0.0001). CONCLUSIONS: This study shows that several technical measures, including appropriate annulus decalcification, precise positioning of guiding sutures, release of traction sutures applied to the valve commissures, and ballooning with reduced pressure, all reduce the rate of PPM implantation after sutureless AVR. Furthermore, a high proportion of patients were found to be no longer pacemaker dependent at follow-up.
BACKGROUND: Several studies reported high rates of postoperative permanent pacemaker (PPM) implantation, which has been described as the "Achilles' heel" of sutureless aortic valve replacement (AVR). METHODS: From July 2010 to December 2017, 3,158 patients with symptomatic, severe aortic valve stenosis were referred to the Department of Cardiac Surgery (Klinikum Nürnberg - Paraclesus Medical University, Nuremberg, Germany), and 512 received a Perceval sutureless bioprosthesis (LivaNova PLC, London, United Kingdom). Thirty-nine patients who had been discharged with concomitant PPM implantation were reevaluated. RESULTS: After a cumulative follow-up of 1,534 months (100% complete, median 50 months, interquartile range 30 months, maximum 76 months, minimum 3 months), a total of 22 patients were still pacemaker dependent. Kaplan-Meier analysis showed pacemaker-dependent rhythm in 92.0%, 80.0%, 49.4%, and 32.3% of patients at 1, 2, 4, and 5 years, respectively. At Cox regression analysis, pressure during valve deployment (hazard ratio, 79.41; p = 0.0003) and "late-onset" atrioventricular block were found to be independent predictors of sinus rhythm restoration (hazard ratio, 0.16; p = 0.0061). Log-rank test showed significantly lower pacemaker dependency rates in patients with "low-pressure" prosthesis implantation (p < 0.0001). CONCLUSIONS: This study shows that several technical measures, including appropriate annulus decalcification, precise positioning of guiding sutures, release of traction sutures applied to the valve commissures, and ballooning with reduced pressure, all reduce the rate of PPM implantation after sutureless AVR. Furthermore, a high proportion of patients were found to be no longer pacemaker dependent at follow-up.
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