OBJECTIVE: Transapical-aortic valve implantation (TA-AVI) has evolved as routine for selected high-risk patients. However, paravalvular leaks >1+ remain an unsolved issue using current generations of transcatheter valve devices. The purpose of this study was to investigate the impact of native aortic valve calcification on paravalvular leaks and outcomes using the Edwards SAPIEN™ prosthesis. METHODS: One hundred and twenty consecutive patients (out of 307 TA-AVIs) with preoperative computed tomography aged 82.6 ± 6.2 years, 75.0% female were included. Implanted prosthetic valve sizes were 23 mm (n = 31) and 26 mm (n = 89), respectively. Mean logistic European System for Cardiac Operative Risk Evaluation-Score was 30.1 ± 15.5% and mean Society of Thoracic Surgeons-Score was 12.8 ± 7.9%. Electrocardiographic (ECG)-gated cardiac computed tomography allowed to quantify the amount of calcification of aortic valve leaflets using a scoring analogous to the Agatston calcium scoring of coronary arteries [Aortic Valve Calcium Scoring (AVCS)]. Paravalvular leaks were assessed intraoperatively by echocardiography and root angiography. RESULTS: All valves were implanted successfully. The mean AVCS in patients without paravalvular leaks (n = 66) was 2704 ± 1510; with mild paravalvular leaks (n = 31) was 3804 ± 2739 (P = 0.05); and with moderate paravalvular leaks (n = 4) was 7387 ± 1044 (P = 0.002). There was a significant association between the AVCS and paravalvular leaks [odds ratio (OR; per AVCS of 1000), 11.38; 95% confidence interval (CI) 2.33-55.53; P = 0.001)] and a trend towards a higher incidence of new pacemaker implantation (OR 1.27; 95% CI 0.85-1.89; P = 0.26). No association was found to 30-day mortality, major cardiac events and stroke rate (OR 1.05; 95% CI 0.84-1.32; P = 0.68; OR 0.92; 95% CI 0.68-1.25; P = 0.57 and OR 0.90; 95% CI 0.41-1.96; P = 0.79, respectively). Overall 30-day mortality was 14.2%. CONCLUSION: Severe native valve calcifications are predictive for postoperative relevant paravalvular leak. AVCS prior to TA-AVI might serve as an additional tool to reconsider the TAVI indication to reduce the risk of paravalvular leaks especially in so-called operable patients.
OBJECTIVE: Transapical-aortic valve implantation (TA-AVI) has evolved as routine for selected high-risk patients. However, paravalvular leaks >1+ remain an unsolved issue using current generations of transcatheter valve devices. The purpose of this study was to investigate the impact of native aortic valve calcification on paravalvular leaks and outcomes using the Edwards SAPIEN™ prosthesis. METHODS: One hundred and twenty consecutive patients (out of 307 TA-AVIs) with preoperative computed tomography aged 82.6 ± 6.2 years, 75.0% female were included. Implanted prosthetic valve sizes were 23 mm (n = 31) and 26 mm (n = 89), respectively. Mean logistic European System for Cardiac Operative Risk Evaluation-Score was 30.1 ± 15.5% and mean Society of Thoracic Surgeons-Score was 12.8 ± 7.9%. Electrocardiographic (ECG)-gated cardiac computed tomography allowed to quantify the amount of calcification of aortic valve leaflets using a scoring analogous to the Agatston calcium scoring of coronary arteries [Aortic Valve Calcium Scoring (AVCS)]. Paravalvular leaks were assessed intraoperatively by echocardiography and root angiography. RESULTS: All valves were implanted successfully. The mean AVCS in patients without paravalvular leaks (n = 66) was 2704 ± 1510; with mild paravalvular leaks (n = 31) was 3804 ± 2739 (P = 0.05); and with moderate paravalvular leaks (n = 4) was 7387 ± 1044 (P = 0.002). There was a significant association between the AVCS and paravalvular leaks [odds ratio (OR; per AVCS of 1000), 11.38; 95% confidence interval (CI) 2.33-55.53; P = 0.001)] and a trend towards a higher incidence of new pacemaker implantation (OR 1.27; 95% CI 0.85-1.89; P = 0.26). No association was found to 30-day mortality, major cardiac events and stroke rate (OR 1.05; 95% CI 0.84-1.32; P = 0.68; OR 0.92; 95% CI 0.68-1.25; P = 0.57 and OR 0.90; 95% CI 0.41-1.96; P = 0.79, respectively). Overall 30-day mortality was 14.2%. CONCLUSION: Severe native valve calcifications are predictive for postoperative relevant paravalvular leak. AVCS prior to TA-AVI might serve as an additional tool to reconsider the TAVI indication to reduce the risk of paravalvular leaks especially in so-called operable patients.
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