Sutureless and Rapid Deployment Prosthesis in Redo-Bentall Endocarditis.

With improving technologies and an increasingly elderly populations, there have been an increasing number of therapeutic options available for patients requiring aortic valve replacement. Recent evidence suggests that transcatheter aortic valve implantation (TAVI) is one suitable option for high risk inoperable patients, as well as high risk operable patients. Sutureless valve technology has also been developed concurrently, with facilitates surgical aortic valve replacement (SUAVR) by allow resection and replacement of the native aortic valve with minimal sutures and prosthesis anchoring required. For patients amenable for both TAVI and SUAVR, the evidence is unclear with regards to the benefits and risks of either approach. The objectives are to compare the perioperative outcomes and intermediate-term survival rates of TAVI and SUAVR in matched or propensity score matched studies. A systematic literature search was performed to include all matched or propensity score matched studies comparing SUAVR versus TAVI for severe aortic stenosis. A meta-analysis with odds ratios (OR) and mean differences were performed to compare key outcomes including paravalvular regurgitation and short and intermediate term mortality. Six studies met our inclusion criteria giving a total of 741 patients in both the SUAVR and TAVI arm of the study. Compared to TAVI, SUAVR had a lower incidence of paravalvular leak (OR =0.06; 95% CI: 0.03-0.12, P<0.01). There was no difference in perioperative mortality, however SUAVR patients had significantly better survival rates at 1 (OR =2.40; 95% CI: 1.40-4.11, P<0.01) and 2 years (OR =4.62; 95% CI: 2.62-8.12, P<0.01). The present study supports the use of minimally invasive SUAVR as an alternative to TAVI in high risk patients requiring aortic replacement. The presented results require further validation in prospective, randomized controlled studies.

Invited Commentary

Robotic aortic valve replacement

Background: Although sutureless aortic valve replacement is rising in popularity, there are few reports on its use in patients on dialysis. This study aimed to investigate the early and mid-term surgical outcomes of the procedure in these patients. Methods: Twenty-one dialysis (mean age, 77.4 ± 5.2 years) patients with aortic stenosis who underwent aortic valve replacement with sutureless and rapid deployment prostheses between May 2019 and March 2021 were enrolled. We retrospectively reviewed and analyzed the clinical courses of all dialysis patients. Data on patient characteristics, surgical procedures, and postoperative outcomes (survival times and major adverse cardiac and cerebrovascular events) were collected. The mean follow-up duration was 371 days (interquartile range (IQR) 364–399). Results: Two (9.5%) operative deaths occurred within 30 days of surgery. The 1-year survival was 85.7%, and the rates of freedom from cardiac death, myocardial infarction, and stroke were 95.0%, 89.7%, and 95.0%, respectively. 1 year freedom from major adverse cardiac and cerebrovascular events was 67.8%. There was one (5.5%) permanent pacemaker implantation 9 months after surgery. No reoperations were performed for any cause. Three patients had moderate prosthesis-patient mismatch 4–7 days after surgery. Effective orifice area index improved from 0.74 cm2/m2 to 0.87 cm2/m2 in one patient 1 year after surgery. No cases of structural valve deterioration or a paravalvular leak were observed. Conclusions: Sutureless aortic valve replacement in dialysis patients may be a novel treatment strategy with lower early mortality rates comparable to those of conventional treatments, increased freedom from pacemaker implantation, and good valve function.

ObjectiveSutureless aortic valves are an effective option for aortic valve replacement (AVR) showing non-inferiority to standard stented aortic valves for major cardiovascular and cerebral events at 1-year. We report the 1-year hemodynamic performance of the sutureless prostheses compared with standard aortic valves, assessed by a dedicated echocardiographic core lab.MethodsPerceval Sutureless Implant vs. Standard Aortic Valve Replacement (PERSIST-AVR) is a prospective, randomized, adaptive, open-label trial. Patients undergoing AVR, as an isolated or combined procedure, were randomized to receive a sutureless [sutureless aortic valve replacement (Su-AVR)] (n = 407) or a stented sutured [surgical AVR (SAVR)] (n = 412) bioprostheses. Site-reported echocardiographic examinations were collected at 1 year. In addition, a subgroup of the trial population (Su-AVR n = 71, SAVR = 82) had a complete echocardiographic examination independently assessed by a Core Lab (MedStar Health Research Institute, Washington D.C., USA) for the evaluation of the hemodynamic performance.ResultsThe site-reported hemodynamic data of stented valves and sutureless valves are stable and comparable during follow-up, showing stable reduction of mean and peak pressure gradients through one-year follow-up (mean: 12.1 ± 6.2 vs. 11.5 ± 4.6 mmHg; peak: 21.3 ± 11.4 vs. 22.0 ± 8.9 mmHg). These results at 1-year are confirmed in the subgroup by the core-lab assessed echocardiogram with an average mean and peak gradient of 12.8 ± 5.7 and 21.5 ± 9.1 mmHg for Su-AVR, and 13.4 ± 7.7 and 23.0 ± 13.0 mmHg for SAVR. The valve effective orifice area was 1.3 ± 0.4 and 1.4 ± 0.4 cm2 at 1-year for Su-AVR and SAVR. These improvements are observed across all valve sizes. At 1-year evaluation, 91.3% (n = 42) of patients in Su-AVR and 82.3% in SAVR (n = 51) groups were free from paravalvular leak (PVL). The rate of mild PVL was 4.3% (n = 2) in Su-AVR and 12.9% (n = 8) in the SAVR group. A similar trend is observed for central leak occurrence in both core-lab assessed echo groups.ConclusionAt 1-year of follow-up of a PERSIST-AVR patient sub-group, the study showed comparable hemodynamic performance in the sutureless and the stented-valve groups, confirmed by independent echo core lab. Perceval sutureless prosthesis provides optimal sealing at the annulus with equivalent PVL and central regurgitation extent rates compared to sutured valves. Sutureless valves are therefore a reliable and essential technology within the modern therapeutic possibilities to treat aortic valve disease.

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Invited Commentary

Sutureless aortic valves demonstrated non-inferiority to standard stented valves for major cardiovascular and cerebral events at 1 year after aortic valve replacement. We aim to assess the factors correlating with permanent pacemaker implantation (PPI) in both cohorts. PERSIST-AVR is a prospective, randomized, open-label trial. Patients undergoing aortic valve replacement were randomized to receive a sutureless aortic valve replacement (Su-AVR) or stented sutured bioprosthesis (SAVR). Multivariable analysis was performed to identify possible independent risk factors associated with PPI. A logistic regression analysis was performed to estimate the risk of PPI associated to different valve size. The 2 groups (Su-AVR; n = 450, SAVR n = 446) were well balanced in terms of preoperative risk factors. Early PPI rates were 10.4% in the Su-AVR group and 3.1% in the SAVR. PPI prevalence correlated with valve size XL (P = 0.0119) and preoperative conduction disturbances (P = 0.0079) in the Su-AVR group. No predictors were found in the SAVR cohort. Logistic regression analysis showed a significantly higher risk for PPI with size XL compared to each individual sutureless valve sizes [odds ratio (OR) 0.272 vs size S (95%confidence interval 0.07-0.95), 0.334 vs size M (95% CI 0,16-0; 68), 0.408 vs size L (95% CI 0,21-0.81)] but equivalent risk of PPI rates for all other combination of valve sizes. Su-AVR is associated with higher PPI rate as compared to SAVR. However, the increased PPI rate appears to be size-dependent with significant higher rate only for size XL. The combination of preoperative conduction disorder and a size XL can lead to a higher probability of early PPI in Su-AVR. NCT02673697.

Concomitant aortic and mitral valve replacement or concomitant aortic valve replacement and mitral repair can be a challenge for the cardiac surgeon: in particular, because of their structure and design, two bioprosthetic heart valves or an aortic valve prosthesis and a rigid mitral ring can interfere at the level of the mitroaortic junction. Therefore, when a mitral bioprosthesis or a rigid mitral ring is already in place and a surgical aortic valve replacement becomes necessary, or when older high-risk patients require concomitant mitral and aortic procedures, the new 'fast-implantable' aortic valve system (Intuity valve, Edwards Lifesciences, Irvine, CA, USA) can represent a smart alternative to standard aortic bioprosthesis. Unfortunately, this is still controversial (risk of interference). However, transcatheter aortic valve replacements have been performed in patients with previously implanted mitral valves or mitral rings. Interestingly, we learned that there is no interference (or not significant interference) among the standard valve and the stent valve. Consequently, we can assume that a fast-implantable valve can also be safely placed next to a biological mitral valve or next to a rigid mitral ring without risks of distortion, malpositioning, high gradient or paravalvular leak. This paper describes two cases: a concomitant Intuity aortic valve and bioprosthetic mitral valve implantation and a concomitant Intuity aortic valve and mitral ring implantation.

Commentary: Greater risk of infective endocarditis after biologic valve replacement: A word of caution before expanding the indications to younger patients

Transcatheter Aortic Valve-in-Valve-in-Valve Implantation for a Failed Xenograft

Sutureless aortic valve replacement (SU-AVR) and transcatheter aortic valve implantation (TAVI) have expanded treatment options for severe aortic stenosis, but comparative real-world data remain limited. We aimed to compare early and up to 6-month clinical and hemodynamic outcomes of SU-AVR versus transfemoral TAVI. All consecutive patients undergoing SU-AVR (n = 53) or TAVI (n = 245) between 2014 and 2023 were retrospectively analyzed. Propensity score matching (1:1 nearest neighbor, no replacement) generated 53 balanced pairs. Paravalvular leak was more frequent after TAVI and was driven by mild leaks (40.0% vs. 13.3%; P = 0.019), while moderate-to-severe paravalvular leak was low and comparable (6.7% vs. 3.3%; P = 0.646). TAVI demonstrated lower transvalvular gradients compared to SU-AVR (P = 0.004); other 6-month echocardiographic parameters, including left ventricular ejection fraction and pulmonary artery pressure, were comparable. Permanent pacemaker implantation rates were comparable. Early mortality did not differ between the SU-AVR and TAVI groups (13.5% vs. 5.7%; P = 0.173). TAVI was associated with shorter hospitalization (median 5.2, interquartile range 3.7-7.3 vs. 8.7, interquartile range 6.3-11.9 days; P <0.001). In selected high-risk patients, SU-AVR and TAVI showed complementary early profiles. Individualized Heart Team-based decision-making remains essential.

Failed bioprosthetic valve approaches: Transcatheter aortic valve replacement approach

Cost-Effectiveness of Transcatheter Aortic Valve Replacement Compared With Surgical Aortic Valve Replacement in High-Risk Patients With Severe Aortic Stenosis: Results of the PARTNER (Placement of Aortic Transcatheter Valves) Trial (Cohort A)

Sutureless Implantation of the Perceval S Aortic Valve Prosthesis Through Right Anterior Minithoracotomy