Rapid Deployment Aortic Valve Replacement Research Articles

Successful Implantation of Rapid Deployment Aortic Valve after TAVR Explantation.

Transcatheter aortic valve replacement (TAVR) has become widely used in recent years, However, there is also an increasing need for removal of TAVR valves due to prosthetic valve dysfunction (PVD) and the development of infective endocarditis. Surgical aortic valve replacement (AVR) for these patients is risky due to the original patient background and anatomic conditions. Intuity rapid deployment aortic valve (Edwards Lifesciences, Irvine, CA) replacement would be useful for such high risk patients to prevent longer cardiac arrest time and obtain good hemodynamic results. However, there are few reports which present Intuity valve replacement after TAVR explantation. Herein, We report two cases in which we have achieved good hemodynamics with shorter cardiac arrest times by using a rapid deployment valve after TAVR explantation. We present 2 cases of successful implantation of the Intuity rapid deployment valve after TAVR explantation. The 84- and 88-year-old female patients had previously received TAVR for severe aortic stenosis with SAPIEN XT (Edwards Lifesciences, Irvine, CA) and developed PVD during follow-up. The TAVR valve was removed carefully, then an Intuity valve was implanted with cardiac arrest times of 69 and 41min. Both patients had good echocardiographic results with effective orifice area of 2.0cm2 and 1.2cm2 and mean trans-aortic plessure gradient of 9 mmHg and 15 mmHg respectively without aortic regurgitation. They were discharged without major complications. Surgical AVR using a rapid deployment valve is a useful alternative to sutured AVR after TAVR valve explantation. It allows for shorter cardiac arrest times and better postoperative hemodynamics without major complication.

Cost-utility analysis of sutureless and rapid deployment versus conventional aortic valve replacement in patients with moderate to severe aortic stenosis in Thailand.

Sutureless and rapid deployment aortic valve replacement (SUAVR) has become an alternative to conventional aortic valve replacement (CAVR) for aortic stenosis (AS) treatment due to its advantages in reducing surgery time and improving outcomes. This study aimed to assess the cost-utility of SUAVR vs. CAVR treatment for patients with moderate to severe AS in Thailand. A two-part constructed model was used to estimate the lifetime costs and quality-adjusted life years (QALYs) from both societal and healthcare perspectives. Data on short-term mortality, complications, cost, and utility data were obtained from the Thai population. Long-term clinical data were derived from clinical studies. Costs and QALYs were discounted annually at 3% and presented as 2022 values. The incremental cost-effectiveness ratio (ICER) was calculated to determine additional cost per QALY gained. Deterministic and probabilistic sensitivity analyses were performed. SUAVR treatment incurred higher costs compared with CAVR treatment from both societal (THB 1,733,355 [USD 147,897] vs THB 1,220,643 [USD 104,150]) and healthcare provider perspectives (THB 1,594,174 [USD 136,022] vs THB 1,065,460 [USD 90,910]). In addition, SUAVR treatment resulted in lower health outcomes, with 6.20 life-years (LYs) and 4.95 QALYs, while CAVR treatment achieved 6.29 LYs and 5.08 QALYs. SUAVR treatment was considered as a dominated treatment strategy using both perspectives. Sensitivity analyses indicated the significant impact of changes in utilities and long-term mortality on the model. SUAVR treatment is not a cost-effective treatment strategy compared with CAVR treatment for patients with moderate-severe AS in Thailand, as it leads to higher costs and inferior health outcomes. Other important issues related to specific patients such as those with minimally invasive surgery, those undergoing AVR with concomitant procedures, and those with calcified and small aortic root should be taken into account.

Comparable Outcomes of Bicuspid Aortic Valves for Rapid-Deployment Aortic Valve Replacement.

Edwards Intuity is recognized as a relatively contraindicated bioprosthesis for bicuspid aortic valve disease. This study compared the early echocardiographic and clinical outcomes of rapid-deployment aortic valve replacement for bicuspid versus tricuspid aortic valves. Of 278 patients who underwent rapid-deployment aortic valve replacement using Intuity at Seoul National University Hospital, 252 patients were enrolled after excluding those with pure aortic regurgitation, prosthetic valve failure, endocarditis, and quadricuspid valves. The bicuspid and tricuspid groups included 147 and 105 patients, respectively. Early outcomes and the incidence of paravalvular leak were compared between the groups. A subgroup analysis compared the outcomes for type 0 versus type 1 or 2 bicuspid valves. The bicuspid group had more male and younger patients. Comorbidities, including diabetes mellitus, hypertension, chronic kidney disease, and coronary artery disease, were less prevalent in the bicuspid group. Early echocardiographic evaluations demonstrated that the incidence of ≥mild paravalvular leak did not differ significantly between the groups (5.5% vs. 1.0% in the bicuspid vs. tricuspid groups, p=0.09), and the early clinical outcomes were also comparable between the groups. In the subgroup analysis between type 0 and type 1 or 2 bicuspid valves, the incidence of mild or greater paravalvular leak (2.4% vs. 6.7% in type 0 vs. type 1 or 2, p=0.34) and clinical outcomes were comparable. Rapid-deployment aortic valve replacement for bicuspid aortic valves demonstrated comparable early echocardiographic and clinical outcomes to those for tricuspid aortic valves, and the outcomes were also satisfactory for type 0 bicuspid aortic valves.

Outcomes of Rapid Deployment Aortic Valve Replacement: Early Experience in Wellington Hospital

Rapid deployment (RD) aortic valve replacement (AVR) using the Edwards Intuity Elite Valve System is a significant breakthrough in advancement in comparison with other current conventional sutured surgical AVR. This study aimed to analyse early experiences using this novel bioprosthesis. This 60-month prospective study, between July 2017 and July 2022, found that 59 patients had RD bioprosthesis implanted at this institution. Median follow-up period was 12 months. Baseline preoperative characteristics, isolated or concomitant procedures, valve prosthesis-related events, survival rates, and valve haemodynamics were evaluated. Primary endpoints were pacemaker implantation (PPM) rates, neurological events, paravalvular leaks, and early 30-day mortality rates. Secondary endpoints were reintervention, valve degeneration, arrhythmia, hospital stay, and readmission rates. Approximately 64% were males, with the mean age of 75±3 years. Isolated AVR was performed in 54% and the rest were concomitant procedures. Cardiopulmonary bypass and cross-clamping times were acceptable. In the isolated AVR group, the early PPM implantation rates were 5%, with 1.7% of patients experiencing a minor stroke event. One patient had paravalvular leak, which was moderate in haemodynamics. Mean gradient at discharge was 11±3 mmHg. There was no early inpatient mortality in the isolated AVR group, and the 30-day post-discharge mortality was zero. Re-operation rates and valve degeneration rates were zero. This study found promising and excellent early results in this small cohort of patients, validating for more usage of rapid deployment AVR in suitable patients.

Outcomes of Rapid Deployment Aortic Valve Replacement: Early Experience in Wellington Hospital

Rapid deployment (RD) aortic valve replacement (AVR) using the Edwards Intuity Elite Valve System is a significant breakthrough in advancement in comparison with other current conventional sutured surgical AVR. This study aimed to analyse early experiences using this novel bioprosthesis.

Sutureless vs. rapid-deployment valve: a systemic review and meta-analysis for a direct comparison of intraoperative performance and clinical outcomes.

Sutureless and rapid-deployment valves are bioprostheses anchoring within the aortic annulus with few sutures, and they act as a hybrid of conventional surgical and transcatheter valves under aortic valve replacement. Considering that the 3F Enable valve is now off-market, the only two sutureless and rapid-deployment valves available on the world marketplace are the Perceval and Intuity valves. However, a direct comparison of the function of these two valves eludes researchers. Against this background, we performed this systematic review and meta-analysis comparing the intraoperative performance and early clinical outcomes between the Perceval valve and the Intuity valve under sutureless and rapid-deployment aortic valve replacement. We systematically searched electronic databases through PubMed/MEDLINE, OvidWeb, Web of Science, and Cochrane Central Register of Controlled Trials (from the establishment of the database to November 17, 2022, without language restriction) for studies comparing the sutureless valve (the Perceval) and the rapid-deployment valve (the Intuity) under aortic valve replacement. Our primary outcomes were early mortality and postoperative transvalvular pressure gradients. The secondary outcomes were defined to include aortic cross-clamp and cardiopulmonary bypass time, paravalvular leak (any paravalvular leak, moderate-to-severe paravalvular leak) after aortic valve replacement, need for pacemaker implantation, postoperative neurological events (stroke), and intensive care unit stay. This meta-analysis included ten non-randomized trials with 3,526 patients enrolled (sutureless group = 1,772 and rapid-deployment group = 1,754). Quality assessments were performed, with the mean scores of the studies reading 6.90 (SD = 0.99) out of 9 according to the Newcastle-Ottawa Scale. Compared with rapid-deployment aortic valve replacement, sutureless aortic valve replacement was associated with higher mean and peak transvalvular pressure gradients postoperatively. In contrast, aortic cross-clamp and cardiopulmonary time were needed less in sutureless aortic valve replacement vs. rapid-deployment aortic valve replacement. There was no evidence of significant publication bias observed by the funnel plot and Egger's test. For postoperative hemodynamics, sutureless aortic valve replacement was associated with increased mean and peak transvalvular pressure gradients compared with rapid-deployment aortic valve replacement. In sharp contrast, sutureless aortic valve replacement significantly reduced the amount of time needed for fixing the aortic cross-clamp and the cardiopulmonary bypass procedure. https://www.crd.york.ac.uk/prospero/, identifier CRD42022343884.

Rapid-Deployment Aortic Valve Replacement: Patient Selection and Special Considerations.

Sutureless or rapid deployment valves in the setting of aortic valve replacement (AVR) is an emerging surgical technique using the transcatheter valve technology, which may lead to reduction in cross-clamp time and potentially better hemodynamics compared to a stented bioprosthetic valve. The absence of subannular pledgets results to excellent hemodynamic performance with reduced turbulent flow and larger effective orifice area. However, complications from both surgical and transcatheter AVR may still occur and impact survival. The incidence of paravalvular leakage and permanent pacemaker implantation are not low. Although technical modifications can improve these outcomes, there is a learning curve effect. Therefore, technical and anatomical considerations as well as better patient selection are paramount for better outcomes. In this review, we discuss the use of sutureless or rapid deployment valves in setting of (1) complex procedures, (2) minimally invasive AVR, and (3) small aortic annulus. The advantage of sutureless or rapid deployment valves in terms of mortality remains to be clarified; therefore, it is necessary to accumulate long-term outcomes in an appropriate patient cohort.

Early surgical outcomes of rapid deployment aortic valve replacement in bicuspid aortic valves

Early surgical outcomes of rapid deployment aortic valve replacement in bicuspid aortic valves

High Incidence of Transient Permanent Pacemaker Rate After Rapid Deployment Valve Replacement: Insights of a 9-Year Single-Center Experience.

The incidence of new permanent pacemaker implantation (PPI) after rapid deployment aortic valve replacement (RDAVR) remains debated. Expertise in this field has significantly increased over the last decade. This study aimed to investigate the need for PPI following implantation of a rapid deployment (RD) valve. Analysis of n=372 patients who underwent Edwards INTUITY (n=251) and Perceval (n=121) valve replacement at the current institution between May 2012 and August 2018 was performed. Coronary artery bypass graft procedures were additionally performed in patients with coronary artery disease. Baseline, preoperative and postoperative outcomes were examined regarding correctness and completeness of the procedure. Statistical analysis was performed using SPSS Version 23.0.0 (IBM Corp, Armonk, NY, USA). A total of 372 patients (aged 75±6.3 years) with a high grade of aortic valve stenosis underwent either Edwards INTUITY (67%) or Perceval (33%) valve replacement. Seventy-six (76) patients (20%) presented with preoperative conduction disorders. Sixty patients (60) (16%) underwent PPI, which in most cases was performed during the first month after the initial operation. Follow-up was performed up to 9 years, presenting a persistent pacemaker dependency rate of 50% among all patients who underwent PPI. Twenty (20) (40%) PPI recipients showed no dependency on pacemaker, while 10 (10%) required temporary pacemaker support. Mean length of ICU stay was 4±5.1 days and in-hospital stay was 8.2±7.6 days. The incidence of PPI after RD valve implantation still remains high compared with conventional aortic valve replacement. However, this study shows that this phenomenon appears to be transient in a significant proportion of the patients undergoing RD valve replacement. These findings might contribute to the scientific discussion and should be taken into consideration for the indication of RD valve replacement.

Early Outcomes of Intuity Rapid Deployment Aortic Valve Replacement Compared With Conventional Biological Valves in Japanese Patients

This study aimed to elucidate the short-term surgical outcomes and hemodynamics of the Intuity valve compared to the standard bioprosthesis in Japanese patients.Methods and Results: Among the 307 consecutive patients who underwent aortic valve replacement (AVR) between February 2019 and March 2021, the Intuity valve was implanted in 95 patients (Intuity group) and a conventional stented bioprosthesis was implanted in 193 patients (conventional group). After propensity score matching, there was no significant difference in in-hospital mortality between the Intuity (n=2, 3%) and conventional groups (n=0, P=0.490). Operation, cardiopulmonary bypass, and aortic cross-clamping times were significantly shorter in the Intuity group. Although the effective orifice area index, trans-prosthetic mean pressure gradient, and peak velocity were similar between the 2 groups at 1 week postoperatively, the Intuity group showed a better mean pressure gradient and peak velocity at 1 year postoperatively. Complete atrioventricular block requiring permanent pacemaker implantation developed in 2 patients (3%) in the Intuity group and none in the conventional group (P=0.476). Mild or greater paravalvular leakage was present in 8 patients (13%) in the Intuity group and 2 patients (3%) in the conventional group (P=0.095). AVR using the Intuity valve in Japanese patients is satisfactory, with a better valve performance and a low incidence of complete atrioventricular block at 1 year postoperatively.

Rapid-Deployment Aortic Valve Replacement in a Real-World All-Comers Population.

This study was conducted to evaluate the mid-term outcomes of rapid-deployment aortic valve replacement (AVR) using Edwards Intuity. A total of 215 patients underwent rapid-deployment AVR using Edwards Intuity at our institution. The median follow-up duration was 22 months (interquartile range, 8-36). Primary outcomes were overall survival, cumulative incidence of cardiac death, and major adverse cardiac events. Secondary outcomes were early and 1-year hemodynamic performances of the bioprosthetic valve. The mean age was 68.6 ± 10.5 years, and EuroSCORE II was 3.09 ± 4.5. The study population included 113 patients (52.6%) with bicuspid valves (24 patients with type 0 bicuspid valves), 20 patients (9.3%) with pure aortic regurgitation, and 3 patients (1.4%) with infective endocarditis. Isolated AVR was performed in 70 patients (32.4%) and concomitant procedures were performed in 146 patients (67.6%), including aorta surgery (42.3%) and mitral valve procedure (22.3%). Operative mortality was 2.8%. Complete atrioventricular block occurred in 12 patients, but most of them were transient and only 3 patients received permanent pacemaker implantation before discharge. Overall survival at 3 years was 92.3%. Early hemodynamic data showed mean pressure gradients of 15.5 ± 5.0 and 12.7 ± 4.2 mm Hg in the 19 and 21 mm valve, respectively. One-year hemodynamics were also excellent with mean pressure gradients of 14.7 ± 5.3 and 10.7 ± 3.6 mm Hg in the 19 and 21 mm valve, respectively. Based on a real-world all-comers population, rapid-deployment AVR using Edwards Intuity could be performed for various indications, including bicuspid valve, pure aortic regurgitation, and infective endocarditis, and the clinical and hemodynamic outcomes were excellent.

Standard versus rapid-deployment aortic valve replacement and concomitant myocardial revascularization: 5-year bi-centre clinical outcomes.

Clinical outcomes of 2 generations of pericardial bioprostheses in concomitant aortic valve and coronary artery bypass graft surgery were analysed. Patients were recruited from 2 European centres and divided into 2 groups based on the type of aortic bioprosthesis used: Edwards Intuity Elite™ rapid-deployment (RD) bioprostheses or standard Edwards Magna Ease (ME). A propensity score weighting approach was used for data analysis. A total of 285 patients were included: 144 (50.5%) in the RD group and 141 (49.5%) in the ME group. Thirty-day mortality was 2.8% (RD) and 5% (ME) (P = 0.09). Significantly shorter times of aortic cross-clamp and cardiopulmonary bypass were observed in the RD cohort [94 vs 120 min (P < 0.001); 128 vs 160 min (P < 0.001)]. The RD group was associated with a lower median transvalvular gradient at discharge and follow-up (both P < 0.001). However, 5-year survival was not different, being 93% in RD patients and 91% in the ME group [hazard ratio 0.89 (95% confidence interval: 0.38-2.09), P = 0.784]. The 5-year cumulative incidence of combined events (including percutaneous coronary interventions, endocarditis, thromboembolic events, rehospitalizations and bleeding) favoured the ME group [16.1% (RD) vs 7.3% (ME)] [hazard ratio 2.38 (95% confidence interval:1.03-5.52), P = 0.043]. However, this turned similar when the Cox model analysis was adjusted for revascularization variables (P = 0.067). RD and ME pericardial bioprostheses used in concomitant aortic valve replacement and coronary artery revascularization provide equivalent clinical and haemodynamic 5-year outcomes, despite constant lower transvalvular gradients and shorter surgical operating times observed with RD technology.

Incidence of Persistent Left Bundle Branch Block After Rapid-Deployment Aortic Valve Replacement

BackgroundWe evaluated the incidence, prognosis, and predictive factors of new onset of persistent left bundle branch block (NOP-LBBB) after rapid-deployment aortic valve replacement (RD-AVR). MethodsThis was an observational, retrospective, single-center study of 274 consecutive patients with no baseline ventricular conduction disorder and no previous permanent pacemaker implantation (PPI) who underwent RD-AVR with an INTUITY valve (n = 55) or INTUITY Elite Valve (n = 219) (Edwards Lifesciences). Transthoracic echocardiography and 12-lead electrocardiography was performed preoperatively, at discharge, and at 1-month and 1-year intervals. The incidence, prognosis, and predictive factors of NOP-LBBB were evaluated. ResultsNOP-LBBB occurred in 58 patients (21.2%) after discharge. In multivariate analysis, age (P < .01), INTUITY valve diameter ≥23 mm (P = .02), and INTUITY Elite implantation (P = .01) were independent predictors of NOP-LBBB. By 1:1 propensity matching analysis between the NOP-LBBB group and the control group, there were no significant differences in 1-year overall mortality (P = .23), hospitalization for congestive heart failure (P = .99), or PPI (P = .99). NOP-LBBB exposed patients to a high rate of dysrhythmic events (12.1% vs 1.4%, P < .01) and was associated with a significant decrease in left ventricular ejection fraction (0.62 ± 0.095 vs 0.652 ± 0.0783, P = .02) without an impact on New York Heart Association functional status (1.25 ± 0.32 and 1.52 ± 0.70, P = .32). PPI was performed in 17 patients (6.2%) before discharge, including 14 NOP-LBBB patients. ConclusionsNOP-LBBB after RD-AVR is prevalent in patients with no prior conduction disorders. INTUITY Elite is associated with a significantly higher rate of NOP-LBBB. The persistence of NOP-LBBB predisposed patients to the occurrence of high-grade conduction disorders and might have led to PPI but did not increase death or hospitalization for congestive heart failure.

Conduction Block After Rapid-Deployment Aortic Valve Replacement

Incidence of Persistent Left Bundle Branch Block After Rapid-Deployment Aortic Valve ReplacementThe Annals of Thoracic SurgeryPreviewWe evaluated the incidence, prognosis, and predictive factors of new onset of persistent left bundle branch block (NOP-LBBB) after rapid-deployment aortic valve replacement (RD-AVR). Full-Text PDF

Sutureless and rapid deployment versus sutured aortic valve replacement: a propensity-matched comparison from the Sutureless and Rapid Deployment International Registry.

To compare procedural and in-hospital outcomes of patients undergoing sutureless (Perceval, Livanova PLC, London, UK) and rapid deployment (Intuity Elite, Edwards Lifesciences, Irvine, CA, USA) aortic valve replacement (group 1) versus sutured aortic valve replacement (group 2). Patients receiving isolated aortic valve replacement between 2014 and 2020 were analysed using data from the Sutureless and Rapid Deployment International Registry. Patients in group 1 and group 2 were propensity-score matched in a 1:1 ratio. A total of 7708 patients were included in the study. After matching, 2 groups of 2643 each were created. Patients in group 1 were more likely to undergo minimally invasive approaches and were associated with shorter operative times when compared with group 2. Overall in-hospital mortality was similar between groups. While an increased risk of stroke was observed in group 1 in the first study period (2014-2016; relative risk 3.76, P < 0.001), no difference was found in more recent year period (relative risk 1.66, P = 0.08; P for heterogeneity 0.003). Group 1 was associated with reduced rates of postoperative low cardiac output syndrome, atrial fibrillation and mild aortic regurgitation. New pacemaker implant was three-fold higher in group 1. Our findings showed significant differences in procedural and clinical outcomes between the study groups. These results suggest that sutureless and rapid deployment aortic valve replacement should be considered as part of a comprehensive valve programme. The knowledge of the respective post-aortic valve replacement benefits for different valve technologies may result in patient-tailored valve selection with improved clinical outcomes.

Early-Term Results of Rapid-Deployment Aortic Valve Replacement versus Standard Bioprosthesis Implantation Combined with Coronary Artery Bypass Grafting.

Aortic stenosis is highly prevalent among patients with concomitant coronary artery disease. Surgical aortic valve replacement with coronary artery bypass grafting is usually the treatment of choice for patients with severe aortic stenosis and significant coronary disease. The aim of this study was to evaluate the outcome and hemodynamic results of the implantation of rapid-deployment valves (Rapid-Deployment Edwards Intuity Valve System [RDAVR]) versus conventional sutured valves (CSAVR) in combined surgery. Between January 2012 and January 2017, 120 patients underwent replacement via RDAVR and 133 patients underwent replacement using CSAVR with concomitant coronary bypass grafting. Clinical and echocardiographic data were compared. The mean age was 76 ± 7 for RDAVR patients and 74 ± 6 years for CSAVR patients (p = 0.054); 48% in the RDAVR group were female versus 17% in the CSAVR group (p <0.002). Other characteristics such as diabetes mellitus, body-mass index, chronic obstructive pulmonary disease, nicotine consumption, and extracardiac arteriopathy were similar. Coronary three-vessel disease was more common in the RDAVR group (42.5 vs. 27.8%, p = 0.017). Both mean EuroSCORE II (6.6 ± 5.4 vs. 4.3 ± 3.0, p = 0.001) and STS score (5.4 ± 4.4 vs. 3.4 ± 2.4, p = 0.001) were significantly higher in the RDAVR group. Mean cross-clamp time (82 ± 25 vs. 100 ± 30 minutes, p < 0.001) and cardiopulmonary bypass time (119 ± 38 vs. 147 ± 53 minutes, p < 0.001) were shorter with RDAVR. The mean number of bypass grafts, length of hospital and ICU stays, and mechanical ventilation time were not statistically significant different. Hospital mortality was 2.5% for RDAVR and 9.7% for CSAVR (p = 0.019). There was a similar rate of stroke (5.8 vs. 6.0%, p = 0.990) and postoperative delirium (14.1 vs. 15.8%, p = 0.728). Mean gradients were 8.2 ± 4.1 mm Hg in the RDAVR group vs. 11.3 ± 4.6 mm Hg in the CSAVR group (p = 0.001) at discharge. RDAVR combined with coronary artery bypass grafting (CABG) can be performed extremely safely. Cross-clamp and cardiopulmonary bypass times can be significantly reduced with rapid deployment aortic valve system in the scenario of combined CABG. RDAVR resulted in lower gradients than CSAVR in patients implanted with prostheses of the same size.

Outcomes in Patients with Left Bundle Branch Block after Rapid Deployment Aortic Valve Replacement.

Increased rates of postoperative left bundle branch block (LBBB) and permanent pacemaker implantation (PPI) frequently occur after implantation of rapid deployment valves. The impact of LBBB on follow-up outcomes remains controversial. So far, no data regarding long-term outcomes exist. The aim of this study was to analyze the impact of LBBB on postoperative outcomes after rapid deployment aortic valve replacement (RDAVR). A total of 620 consecutive patients without preexisting LBBB or PPI who underwent rapid deployment AVR between March 2012 and September 2019 were included. New-onset LBBB was defined as any new LBBB that persisted at hospital discharge. The median follow-up time for clinical data was 1.7 years post-RDAVR. At discharge, new-onset LBBB was seen in 109 patients (17.5%). There were no differences between the LBBB groups and no-LBBB groups regarding baseline characteristics. At a median follow-up of 1.7 years, no difference was found between LBBB groups and no-LBBB groups concerning all-cause mortality (12.8 vs. 11.7%; hazard ratio [HR]: 1.08; 95% confidence interval [CI]: 0.74-1.53; p = 0.54). Nevertheless, new-onset LBBB was associated with significant higher pacemaker implantation rates at follow-up (10.1 vs. 6.3%; HR: 3.58; 95% CI: 1.89-6.81 p < 0.001). After a median follow-up of 1.7 years, new-onset LBBB was not associated with increased mortality. Nevertheless, higher pacemaker implantation rates were observed in patients with new-onset LBBB after RDAVR.

Rapid-deployment aortic valve replacement for patients with bicuspid aortic valve: a single-centre experience.

The benefit of rapid-deployment aortic valve replacement (RD-AVR) in patients with a bicuspid aortic valve (BAV) is controversial due to aortic root asymmetry and potential increased risk for valve dislocation and paravalvular leak. This study aimed to analyse the outcomes of surgical aortic valve replacement with a rapid-deployment bioprosthesis in patients with a BAV. Between May 2010 and December 2020, all consecutive patients who underwent RD-AVR at the Medical University of Vienna were included in our institutional database. Assessment of preoperative characteristics, operative outcomes, long-term survival and clinical events was performed. The outcomes of patients presenting with a native BAV were compared with a control group of patients with native tricuspid valve (TAV); reoperative aortic valve replacements were excluded. Out of 816 patients, who underwent RD-AVR at our institution, 107 patients with a BAV, mean age 68 (standard deviation: 8) years, were compared with a control group of 690 patients with a TAV, mean age 74 (standard deviation: 7) years; patients presenting with a BAV were significantly younger than patients with a TAV (P < 0.001). Concomitant procedures were performed in 44 (41.1%) patients in the BAV group and in 339 (49.1%) patients in the TAV group (P = 0.123); surgery of the ascending aorta was necessary in 24 (22.4%) in the BAV group, compared with 29 (4.2%) in the control group (P < 0.001). The 5-year cumulative incidence of moderate-to-severe paravalvular regurgitation in the BAV group was 10.7% [95% confidence interval (CI): 4.2-20.7%] and 3.9% (95% CI: 2.4-6.1%) in the TAV group (P = 0.057). Reoperation with valve explantation due to non-structural valve dysfunction at 5 years was 2.8% (95% CI: 0.5-8.8%) in the BAV group, compared to 1.9% (95% CI: 1.0-3.2%) in the TAV cohort (P = 0.89). The overall long-term survival rate in the BAV group was 92% (95% CI: 81-97%) at 5 years and 88% (95% CI: 73-95%), at 10 years, significantly better compared to the TAV group (log-rank test P = 0.002). RD-AVR can be performed in patients with a BAV with convincingly medical outcomes. However, a trend to increased frequency of moderate-severe paravalvular regurgitation was observed at long-term follow-up. Consequently, a different surgical approach, compared to tricuspid valves, with distinctly specific technical- and anatomical considerations and requirements, is recommended.

Evaluation of a rapid deployment prosthesis strategy for the treatment of aortic valve endocarditis.

The aim of this study was to evaluate the surgical outcome of patients suffering from native aortic valve (NVE) or prosthetic aortic valve endocarditis (PVE) treated with the EDWARDS INTUITY Elite rapid-deployment valve prosthesis. Between February 2019 and June 2020, 25 patients suffering from NVE (n = 9; 36%) and PVE (n = 16; 64%) of the aortic valve received an INTUITY valve at our institution. Preoperative, operative and follow-up data were collected. In our cohort, the mean EuroSCORE II was 13.4%. Eleven patients (44%) received concomitant aortic root patch plasty. Four patients (16%) received coronary artery bypass graft surgery, 3 patients (12%) received mitral valve repair and 2 patients (8%) underwent replacement of the ascending aorta. The cardiopulmonary bypass and aortic cross-clamp times were 124 ± 56 and 75 ± 39 min, respectively. The mean intensive care unit stay was 5 days. The mean size of the implanted prostheses was 25 ± 2 mm and the mean prosthesis transvalvular gradient 3 months after surgery was 9 ± 4 mmHg. During follow-up, no case of recurrent endocarditis occurred, 1 patient died of multisystem organ failure which had already been present preoperatively. Surgery for NVE and PVE of the aortic valve may be safely performed using the EDWARDS INTUITY Elite valve system. This procedure could be well implemented in cases with extensive infection, fragile root tissue and root abscesses requiring root reconstruction. In our institution, the rapid-deployment aortic valve replacement strategy has become an important tool in the armamentarium of the surgical endocarditis treatment.

Comparison of Sutureless Bioprosthetic Valve With Surgical or TAVR for SevereAortic Stenosis.

Clinical advantages of sutureless rapid-deployment (RD) aortic valve replacement (AVR) for severe aortic valve stenosis (AS) have not been elucidated compared with surgical (SAVR) or transcatheter (TAVR) aortic valve replacement. This study sought to investigate comparative effectiveness and safety of RD-AVR compared with SAVR and TAVR in a prospective cohort of patients with severe AS. The primary outcome was a composite of death, stroke, or rehospitalization at 12months. Propensity score matching was used to assemble a cohort of patients with similar baseline characteristics. Among 1,020 eligible patients, 107 (10.5%) underwent RD-AVR, 437 (42.8%) underwent SAVR, and 476 (46.7%) underwent TAVR. In the matched cohorts of RD-AVR and SAVR (n=107), the incidence of primary composite outcome at 12months was similar between the 2 groups (8.0% vs 10.8%, respectively; hazard ratio [HR]: 0.74; 95% confidence interval [CI]: 0.30-1.84; P=0.52). In the matched cohorts of RD and TAVR (n=58), the incidence of primary composite outcome at 12months did not statistically differ between the 2 groups (9.4% vs 16.2%, respectively; HR:0.53; 95%CI: 0.18-1.57; P=0.25). In this propensity-matched cohort of patients who underwent AVR for severe AS, we did not detectsignificant differences in the rates of the primary composite of death, stroke, or rehospitalization at 12months when comparing RD-AVR with SAVR and TAVR. Because the study was underpowered, the results should be consideredas hypothesis generating highlighting the need for further research. (ASAN Medical Center Aortic Valve Replacement Registry [ASAN-AVR]; NCT03298178).