ABSTRACT
Aims: When compared with the former Sapien XT (XT-THV), the Sapien 3 trans-catheter heart valve (S3-THV) embeds an outer annular sealing cuff to prevent para-valvular regurgitation (PVR). The consequences of this new feature on valve haemodynamics have never been evaluated. We aimed to compare both types of prostheses regarding patient-prosthesis mismatch (PPM). Methods and results: Patients who underwent a TAVR for aortic stenosis were retrospectively included. Regression adjustment for the propensity score was used to compare 50 XT-THV patients with 71 S3-THV. At the 1-month follow-up, the mean indexed effective orifice area (iEOA) was 1.12 ± 0.34 cm2/m2 with XT-THV and 0.96 ± 0.27 cm2/m2 with S3-THV. The mean gradient was 11 ± 5 mmHg and 13 ± 5 mmHg, respectively. Nine patients had moderate PPM, and two exhibited severe PPM with XT-THV. Nineteen patients had moderate PPM, and seven demonstrated severe PPM with S3-THV. There was a five-fold increased risk of PPM with S3-THV (OR = 4.98; [1.38-20.94], P = 0.019). S3-THV decreased the iEOA by 0.21 cm2/m2 [-0.21; (-0.38 to - 0.05); P = 0.012] and increased the mean gradient by 4.95 mmHg [4.95; (2.27-7.64); P < 0.001]. The risk of PPM was increased 15.24-fold with 23 mm S3-THV [15.24; (2.92-101.52); P = 0.002] in comparison with the 23 mm XT-THV. PVR were reduced by 98% with S3-THV. Conclusion: There is an increased risk of PPM with 23mm S3-THV in comparison with 23 mm XT-THV. This may be attributable to the additional sub-annular cuff that avoids the risk of PVR. Regarding the increased vulnerability of younger patients to PPM, we provide essential information on the extension of TAVR indication to the younger population.
Subject(s)
Aortic Valve Stenosis/surgery , Heart Valve Prosthesis , Hemodynamics/physiology , Prosthesis Failure , Transcatheter Aortic Valve Replacement/adverse effects , Aged , Aged, 80 and over , Cardiac Catheterization/methods , Cohort Studies , Echocardiography, Doppler/methods , Female , France , Hospitals, University , Humans , Logistic Models , Male , Postoperative Complications/diagnostic imaging , Postoperative Complications/physiopathology , Prognosis , Propensity Score , Prosthesis Design , Retrospective Studies , Risk Assessment , Statistics, Nonparametric , Transcatheter Aortic Valve Replacement/methods , Treatment OutcomeABSTRACT
OBJECTIVES: This study aimed to evaluate the safety and effectiveness of rapid-deployment aortic valve replacement (RDAVR) for severe aortic stenosis (AS). METHODS: All consecutive patients with severe AS who underwent RDAVR with the EDWARDS INTUITY bioprosthesis were prospectively included in a single-centre, cohort study between July 2012 and April 2015. Clinical examination and transthoracic echocardiography were performed preoperatively and at 1-month and 1-year follow-up. RESULTS: We included 150 patients: mean age 76.8 ± 6.2 years, 68.7% male and mean EuroSCORE II 3.4 ± 3.7%. Implantation was successful in all: 103 (68.7%) had isolated aortic valve replacement (AVR) and 47 (31.3%) had concomitant procedures. For isolated AVR, mean cross-clamp and cardiopulmonary bypass times were 37.6 ± 13.3 and 59.9 ± 20.4 min, respectively. Overall, the 1-year Kaplan-Meier survival rate was 97.1% (95% confidence interval 92.4-98.9%). At 1 year, stroke occurred in 5 patients (3.34%), myocardial infarction in 1 (0.69%), endocarditis in 1 (0.69%), early explantation in 1 (0.67%), pacemaker implantation in 8 (5.6%) and Grade 2 periprosthetic regurgitation in 4 (3.2%; no grade 3 of 4). There were significant decreases from baseline ( P < 0.001) in the proportion at New York Heart Association Class III/V (35.3-4.1%), mean gradient (54.9 ± 17.3 mmHg to 11.3 ± 4.8 mmHg) and mean left ventricular mass index (160.3 ± 44.8 g/m 2 to 118.5 ± 39.4 g/m 2 ). Mean indexed effective orifice area at 1 year was 1.02 ± 0.37 cm 2 /m 2 . Ten patients (6.6%) had severe patient-prosthesis mismatch. CONCLUSIONS: RDAVR for severe AS provided favourable outcomes over 1 year.
