Carlo Bassano1, Valentina Gislao2, Emanuele Bovio2, Sonia Melino3, Ilaria Tropea2, Guglielmo Saitto2, Marta Pugliese2, Dionisio F Colella4, Antonio Scafuri2, Giovanni Ruvolo2. 1. Cardiac Surgery, Department of Surgery, Tor Vergata University, Rome, Italy. Electronic address: carlo.bassano@uniroma2.it. 2. Cardiac Surgery, Department of Surgery, Tor Vergata University, Rome, Italy. 3. Biochemistry, Department of Chemical Sciences and Technologies, Tor Vergata University, Rome, Italy. 4. Cardioanesthesia, Department of Emergency Care and Anesthesia, Tor Vergata University, Rome, Italy.
Abstract
BACKGROUND: An alarming rate of early failure has been recently reported for the LivaNova (previously Sorin) Mitroflow (LivaNova, London, UK) bioprosthesis. Here, we aimed at verifying if this possible underperformance is confirmed in a large, single-center experience and identifying the risk factors associated with early deterioration. METHODS: In all, 459 Mitroflow valves have been implanted from July 2009 to December 2013 (patients' mean age 73 years; 204 women). Surviving patients have undergone yearly clinic and echocardiographic follow-up. Dysfunction was defined as moderate if the mean gradient was more than 30 mm Hg or severe if it exceeded 40 mm Hg. The population was divided on the basis of a dimensional mismatch, the model of the prosthesis (LX or DL: follow-up to 4 years), and patient's age at the time of implantation. RESULTS: Cumulative freedom from moderate valve dysfunction was 81% ± 3% at 60 months. It was lower with patient-prosthesis mismatch (71% ± 5% versus 92% ± 3%; p = 0.0065) and with the more recent DL model (at 42 months: 78% ± 6% versus 96% ± 2%; p < 0.0001). Cumulative freedom from severe dysfunction was 93% ± 2% at 5 years. Again, it was inferior among patients with a mismatch (86% ± 4% versus 100%; p = 0.0013) and for the DL model (42 months: 92.5% ± 3% versus 98.5% ± 1%; p = 0.0309). Smaller prostheses showed higher rates of early degeneration. CONCLUSIONS: The LivaNova Mitroflow valve appears to be prone to early deterioration. Smaller size prostheses should be used cautiously and avoided with patient-prosthesis mismatch. The DL model anticalcification treatment seems unable to prevent early degeneration, and possibly contributes to even earlier failure.
BACKGROUND: An alarming rate of early failure has been recently reported for the LivaNova (previously Sorin) Mitroflow (LivaNova, London, UK) bioprosthesis. Here, we aimed at verifying if this possible underperformance is confirmed in a large, single-center experience and identifying the risk factors associated with early deterioration. METHODS: In all, 459 Mitroflow valves have been implanted from July 2009 to December 2013 (patients' mean age 73 years; 204 women). Surviving patients have undergone yearly clinic and echocardiographic follow-up. Dysfunction was defined as moderate if the mean gradient was more than 30 mm Hg or severe if it exceeded 40 mm Hg. The population was divided on the basis of a dimensional mismatch, the model of the prosthesis (LX or DL: follow-up to 4 years), and patient's age at the time of implantation. RESULTS: Cumulative freedom from moderate valve dysfunction was 81% ± 3% at 60 months. It was lower with patient-prosthesis mismatch (71% ± 5% versus 92% ± 3%; p = 0.0065) and with the more recent DL model (at 42 months: 78% ± 6% versus 96% ± 2%; p < 0.0001). Cumulative freedom from severe dysfunction was 93% ± 2% at 5 years. Again, it was inferior among patients with a mismatch (86% ± 4% versus 100%; p = 0.0013) and for the DL model (42 months: 92.5% ± 3% versus 98.5% ± 1%; p = 0.0309). Smaller prostheses showed higher rates of early degeneration. CONCLUSIONS: The LivaNova Mitroflow valve appears to be prone to early deterioration. Smaller size prostheses should be used cautiously and avoided with patient-prosthesis mismatch. The DL model anticalcification treatment seems unable to prevent early degeneration, and possibly contributes to even earlier failure.
Authors: Giovanni Alfonso Chiariello; Emmanuel Villa; Antonio Messina; Stefano Marwan Mangini; Massimiliano Rozzi; Margherita Dalla Tomba; Ornella Leonzi; Giovanni Troise Journal: Cardiol Res Date: 2018-04-25