One-year clinical outcomes following Edwards INSPIRIS RESILIA aortic valve implantation in 487 young patients with severe aortic stenosis: a single-center experience.

Introduction: The use of an aortic bioprosthesis is on the rise in younger patients with severe aortic stenosis despite the risk of accelerated structural valve degeneration (SVD). In the search for an optimal valve substitute that would not be prone to SVD, the INSPIRIS bioprosthesis represents a promising solution to lowering the risk of SVD. Here, we report the 1-year outcomes of the INSPIRIS RESILIA aortic bioprosthesis in a population of young patients who underwent aortic valve replacement. Methods: In this prospective single-center study, we included all consecutive patients receiving INSPIRIS RESILIA bioprosthesis between June 2017 and July 2021. Patients with isolated severe aortic regurgitation were excluded. Clinical assessment and transthoracic echocardiography were performed preoperatively and at 1 year post-operatively. The primary outcome was overall mortality at one year. Results: A total of 487 patients were included. The mean age was 58.2 ± 11.5 years, 75.2% were men. Most of the interventions were elective, with a mean EuroSCORE II of 4.8 ± 7.9. The valve annulus size in most cases was either 23 mm or 25 mm. Overall mortality at 1-year was 4.1%. At 1-year, 7 patients (1.4%) had a stroke, 4 patients (0.8%) had a myocardial infarction, and 20 patients (4.1%) were hospitalized for congestive heart failure. The Kaplan-Meier estimated survival rates and survival without major adverse cardiac events at 1-year were 96.4% and 96.7%, respectively. At 1-year follow-up, 10 patients (2.1%) had endocarditis and 1 patient (0.2%) had partial prosthetic thrombosis. Pacemaker implantation at 1-year post-operative was necessary in 27 patients (5.5%). Severe patient prosthesis mismatch and severe intra valvular regurgitation were 1.2% and 0.6%, respectively. The Kaplan-Meier estimated survival rates at 1-year of no infective endocarditis preoperative and infective endocarditis preoperative were 97.9 ± 0.7% and 89.5 ± 3.3%, respectively (P < 0.001). Excluding endocarditis-related complication, no structural valve deterioration and no valve failure requiring redo surgery were reported. Conclusion: This is the largest single-center descriptive study of the 1-year outcomes after INSPIRIS RESILIA bioprosthesis implantation. The EDWARDS INSPIRIS RESILIA bioprosthesis provides encouraging clinical outcomes with an excellent 1- year survival rates and good hemodynamic performance. Long-term studies are mandatory to assess valve durability.

Rapid deployment versus trans-catheter aortic valve replacement in intermediate-risk patients: A propensity score analysis.

BACKGROUND: There are insufficient studies comparing rapid deployment aortic valve replacement (RDAVR) and trans-aortic valve replacement (TAVR) in intermediate-risk patients with severe aortic stenosis (AS). AIMS: We compared 2-year outcomes between RDAVR with INTUITY and TAVR with SAPIEN 3 in intermediate-risk patients with AS. METHODS: Inclusion criteria were patients with severe AS at a EuroSCORE II ≥ 4%, who received RDAVR or TAVR implantation and clinical evaluation by the Heart Team. Regression adjustment for the propensity score was used to compare RDAVR and TAVR. Primary outcome was the composite criterion of death, disabling stroke, or rehospitalization. SECONDARY OUTCOMES: major bleeding complications postoperation, paravalvular regurgitation ≥ 2, patient-prosthesis mismatch, and pacemaker implantation. RESULTS: A total of 152 patients were included from 2012 to 2018: 48 in the RDAVR group and 104 in the TAVR group. The mean age was 82.7 ± 6.0,51.3% patients were female, the mean EuroSCORE II was 6.03 ± 1.6%, mean baseline LVEF was 56 ± 13%, mean indexed effective orifice area was 0.41 ± 0.1 cm/m2 , and the mean gradient was 51.7 ± 14.7 mmHg. RDAVR patients were younger (79.5 ± 6 years vs. 82.6 ± 6 years; p = .01), and at higher risk (EuroSCORE II, 6.61 ± 1.8% vs. 5.63 ± 1.5%; p = .005), Twenty-two patients (45.99%) in the RDAVR group and 32 (66.67%) in the TAVR group met the composite criterion. Through the 1:1 propensity score matching analysis, there was a significant difference between the groups, favoring RDAVR (HR = 0.58 [95% CI: 0.34-1.00]; p = .04). No differences were observed in terms of patient-prosthesis mismatch (0.83 [0.35-1.94]; p = .67), major bleeding events (1.33 [0.47-3.93]; p = .59), paravalvular regurgitation ≥ 2 (0.33[0-6.28]; p = .46), or pacemaker implantation (0.84 [0.25-2.84]; p = .77) CONCLUSION: RDAVR was associated with better 2-year outcomes than TAVR in intermediate-risk patients with severe symptomatic AS.

Patient-prosthesis mismatch in new generation trans-catheter heart valves: a propensity score analysis.

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.

Rapid-deployment aortic valve replacement for severe aortic stenosis: 1-year outcomes in 150 patients.

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.

Rapid Deployment of Aortic Bioprosthesis in Elderly Patients With Small Aortic Annulus.

BACKGROUND: Aortic valve replacement in elderly patients with a small aortic annulus remains challenging. Patient-prosthesis mismatch (PPM) should be prevented without impacting operative mortality. Hemodynamic benefits resulting from rapid-deployment aortic valve replacement with the Edwards Intuity bioprosthesis for this indication were evaluated. METHODS: Elective patients with severe aortic stenosis who required an Edwards Intuity bioprosthesis, size 19 mm and 21 mm, were prospectively included between July 2012 and July 2014. Transthoracic echocardiography was performed preoperatively and at 1-month follow-up. RESULTS: Sixty-six consecutive patients (mean age, 78 ± 6.4 years; 54.5% women) were included. The Intuity 19 mm was inserted in 29 patients, and the Intuity 21 mm was inserted in 37 patients. No deaths or aortic annulus ruptures occurred. Mean aortic cross-clamp time was 42.7 ± 18.2 minutes. At the 1-month follow-up, mean New York Heart Association classification was 1.6 ± 0.5 versus 2.2 ± 0.8 (p < 0.001). The mean gradient decreased from 59 ± 17.6 mm Hg to 13.7 ± 4.4 mm Hg (p < 0.001). Mean indexed effective orifice area was 0.77 ± 0.17 cm(2)/m(2) for the Intuity 19 mm and 1.01 ± 0.32 cm(2)/m(2) for the Intuity 21 mm. Twenty-one patients (32%) had a moderate PPM (indexed effective orifice area < 0.85 cm(2)/m(2)), and 10 patients (15%) had a severe PPM (indexed effective orifice area < 0.65 cm(2)/m(2)). The mean gradient was 15.1 ± 3.5 mm Hg and 16.9 ± 4.9 mm Hg in the moderate PPM group and severe PPM group, respectively (p = 0.3). The left ventricular mass index dramatically decreased from 153.2 ± 32.7 g/m(2) to 118.4 ± 20.2 g/m(2) (p < 0.001), and only 1 patient (1.5%) had a periprosthetic regurgitation greater than 1. CONCLUSIONS: Regarding the low rate of severe PPM and the early regression of left ventricular mass, these preliminary studies indicate the potential benefit of the Intuity bioprosthesis in patients with a small aortic annulus. Midterm results should be evaluated.