Sutureless Valves, a "Wireless" Option for Patients With Aortic Valve Disease: JACC State-of-the-Art Review.

Transcatheter technologies triggered the recent revision of the guidelines that progressively widened the indications for the treatment of aortic stenosis. On the surgical realm, a technology avoiding the need for sutures to anchor the prosthesis to the aortic annulus has been developed with the aim to reduce the duration of cardiopulmonary bypass and simplify the process of valve implantation. In addition to a transcatheter aortic valve replacement (TAVR)-like stent that exerts a radial force, these so-called "rapid deployment valves" or "sutureless valves" for aortic valve replacement also have cuffs to improve sealing and reduce the risk of paravalvular leak. Despite promising, the actual advantage of sutureless valves over traditional surgical procedures (surgical aortic valve replacement) or TAVR is still debated. This review summarizes the current comparative evidence reporting outcomes of "sutureless valves" for aortic valve replacement to TAVR and surgical aortic valve replacement in the treatment of aortic valve stenosis.

Comparison of apixaban versus aspirin for the prevention of latent bioprosthetic aortic valve thrombosis: study protocol for a prospective randomized trial.

BACKGROUND: The optimal antithrombotic strategy early after aortic valve replacement surgery with a biological valve remains controversial due to lack of high-quality evidence. Either oral anticoagulants or acetylsalicylic acid should be considered for the first 3 months. Hypo-attenuated leaflet thickening on cardiac computed tomography has been associated with latent bioprosthetic valve thrombosis and may be prevented with anticoagulation. We hypothesize that anticoagulation with apixaban is superior to single antiplatelet therapy with acetylsalicylic acid in reducing hypo-attenuated leaflet thickening of bioprosthetic aortic valve prostheses. METHODS: In this prospective, open-label, randomized trial, patients undergoing isolated aortic valve replacement surgery with rapid deployment bioprosthetic valves will be randomized. The treatment group will receive 5 mg of apixaban twice a day for the first 3 months and 100 mg of acetylsalicylic acid thereafter. The control group will be administered 100 mg of acetylsalicylic acid once a day, indefinitely. After the 3-month treatment period, a contrast-enhanced electrocardiogram-gated cardiac computed tomography will be performed to identify hypo-attenuated leaflet thickening of the bioprosthetic valve. The primary objective of the study is to assess the impact of apixaban on the prevention of hypo-attenuated leaflet thickening at 3 months. The secondary and exploratory endpoints will be clinical outcomes and safety profiles of the two strategies. DISCUSSION: Antithrombotic therapy after aortic valve replacement is used to prevent valve thrombosis and systemic thromboembolism. Latent bioprosthetic valve thrombosis is a precursor of clinically significant prosthetic valve dysfunction or thromboembolic events. The hallmark feature of latent bioprosthetic valve thrombosis is hypo-attenuated leaflet thickening on cardiac computed tomography. Subclinical leaflet thrombosis occurs frequently in bioprosthetic aortic valves, more commonly in transcatheter than in surgical valves. There is no evidence on the effect of direct oral anticoagulants on the incidence of hypo-attenuated leaflet thickening after surgical aortic valve replacement with rapid deployment bioprostheses. TRIAL REGISTRATION: ClinicalTrials.gov NCT06184113. Registered on December 28, 2023.

Surgical explantation for a rapid deployment valve: the 'shave-and-hook technique'.

An 80-year-old female patient underwent redo aortic valve replacement for haemolysis caused by moderate paravalvular leakage 1 year after a 21-mm Intuity Elite valve implantation. The elevatorium passed at the segment with paravalvular leakage. The frame was then bent inward using a hook and the peel around the sawing ring was shaved by an elevatorium. After explantation of the Intuity Elite valve, endoscopic examination showed no sign of annular or sub-annular damage. Conventional aortic valve replacement using a biological valve was performed. We introduce a safe alternative technique for explantation of a rapid deployed valve.

Successful Implantation of Rapid Deployment Aortic Valve after TAVR Explantation.

BACKGROUND: 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. CASE PRESENTATION: 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 41 min. Both patients had good echocardiographic results with effective orifice area of 2.0 cm2 and 1.2 cm2 and mean trans-aortic plessure gradient of 9 mmHg and 15 mmHg respectively without aortic regurgitation. They were discharged without major complications. CONCLUSIONS: 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.

Selective placement of novel compression suture technique to reduce pacemaker implantation rate following surgical aortic valve replacement with rapid deployment INTUITY valve.

OBJECTIVE: The use of RDV in SAVR is associated with risk of conduction abnormality requiring PPM implantation, when compared to conventional bioprosthetic valves. We aimed to evaluate the outcome after selective placement of annular compression sutures during surgical aortic valve replacement (SAVR) using Intuity rapid deployment valve (RDV). METHODS: This is a retrospective study of prospectively enrolled patients receiving SAVR using Intuity RDV. Selective placement of commissural compression suture was assessed for all patients based on their annular morphology. Outcomes including operative mortality, rate of pacemaker rate, paravalvular leak and change in trans-valvular pressure gradient were analyzed. RESULTS: 56 consecutive patients underwent SAVR with the INTUITY RDV at our institution from January 2020 to November 2021. The Mean age of our cohort was 69.9 ± 10.6 years with a EuroSCORE II of 3.4 ± 2.4%. 28.6% (16/56) of patients had notable conduction abnormalities pre-operatively, which included atrial fibrillation and left/right bundle branch block. Compression sutures were selectively applied in 19/56 (33.9%) patients. Of which, 13 were bicuspid aortic valve. Post-operatively, we observed no conduction abnormality requiring PPM implantation. In addition, only 3 of the 56 (5.4%) had any degree of paravalvular leak on post-operative echocardiography (all ≤ mild). The mean reduction in trans-valvular gradient was 29.9 mmHg and the mean pressure gradient at 1 month and 1 year follow-up were 9.3 ± 3.6 mmHg and 10.2 ± 4.1 mmHg, respectively. CONCLUSIONS: Selective placement of compression suture helps to avoid unnecessary oversizing, which may reduce the risk of paravalvular leak and post-operative PPM implantation.

The Perceval Sutureless Bioprosthetic Aortic Valve: Evolution of Surgical Valve Technology.

OBJECTIVE: The surgical treatment of aortic stenosis continues to evolve, and sutureless aortic valve replacement (SUAVR) is an emerging technology. With the Perceval S (Corcym, London, UK) as the only true sutureless valve on the market, the objective of this review is to analyze the current literature on Perceval S. Focusing on valve design and deployment as well as applications of the technology for challenging pathology, clinical outcomes are assessed, including a comparison with transcatheter AVR (TAVR). METHODS: PubMed and MEDLINE were searched by 3 authors for studies analyzing SUAVR from inception to May 19, 2023. RESULTS: SUAVR facilitates minimally invasive surgery and offers an alternative strategy for patients with small aortic annuli. It also has a time-saving advantage for patients who require complex operations. SUAVR results in excellent long-term morbidity, mortality, durability, and hemodynamic function. In comparison with conventional surgical AVR (SAVR), SUAVR does have a greater risk of postoperative pacemaker implantation; however, increasing user experience and refinements in implantation technique have contributed to reductions in this outcome. SUAVR results in morbidity and mortality that is similar to rapid-deployment AVR. Midterm outcomes are superior to TAVR; however, further robust investigation into all of these comparisons is ultimately necessary. CONCLUSIONS: SUAVR bridges the gap in technology between SAVR and TAVR. The application of this exciting technology will undoubtedly grow in the coming years, during which additional investigation is paramount to optimize preoperative planning, valve deployment, and reintervention strategies.

Midterm outcomes of aortic valve replacement using a rapid-deployment valve for aortic stenosis: TRANSFORM trial.

Background: The use of rapid-deployment valves (RDVs) has been shown to reduce the operative time for surgical aortic valve replacement (AVR). Long-term core laboratory-adjudicated data are scarce, however. Here we report final 7-year data on RDV use. Methods: TRANSFORM was a prospective, nonrandomized, multicenter, single-arm trial implanting a stented bovine pericardial valve with an incorporated balloon-expandable sealing frame. A prior published 1-year analysis included 839 patients from 29 centers. An additional 46 patients were enrolled and implanted, for a total of 885 patients. Annual clinical and core laboratory-adjudicated echocardiographic outcomes were collected through 8 years. Primary endpoints were structural valve deterioration (SVD), all-cause reintervention, all-cause valve explantation, and all-cause mortality. Secondary endpoints included hemodynamic performance assessed by echocardiography. The mean duration of follow-up was 5.0 ± 2.0 years. Results: The mean patient age was 73.3 ± 8.2 years. Isolated AVR was performed in 62.1% of the patients, and AVR with concomitant procedures was performed in 37.9%. Freedom from all-cause mortality at 7 years was 76.0% for isolated AVR and 68.2% for concomitant AVR. Freedom from SVD, all-cause reintervention, and valve explantation at 7 years was 97.5%, 95.7%, and 97.8%, respectively. The mean gradient and effective orifice area at 7 years were 11.1 ± 5.3 mm Hg and 1.6 ± 0.3 cm2, respectively. Paravalvular leak at 7 years was none/trace in 88.6% and mild in 11.4%. In patients undergoing isolated AVR, the cumulative probability of pacemaker implantation was 13.9% at 30 days, 15.5% at 1 year, and 21.8% at 7 years. Conclusions: AVR for aortic stenosis using an RDV is associated with low rates of late adverse events. This surgical pericardial tissue platform provides excellent and stable hemodynamic performance through 7 years.

The Northern New England Rapid Deployment Valve Experience: Survival and Procedural Outcomes From 2015 to 2021.

OBJECTIVE: The optimal approach and choice of initial aortic valve replacement (AVR) is evolving in the growing era of transcatheter AVR. Further survival and hemodynamic data are needed to compare the emerging role of rapid deployment (rdAVR) versus stented (sAVR) valve options for AVR. METHODS: The Northern New England Cardiovascular Database was queried for patients undergoing either isolated AVR or AVR + coronary artery bypass grafting (CABG) with rdAVR or sAVR aortic valves between 2015 and 2021. Exclusion criteria included endocarditis, mechanical valves, dissection, emergency case status, and prior sternotomy. This resulted in a cohort including 1,616 sAVR and 538 rdAVR cases. After propensity weighting, procedural characteristics, hemodynamic variables, and survival outcomes were examined. RESULTS: The breakdown of the overall cohort (2,154) included 1,164 isolated AVR (222 rdAVR, 942 sAVR) and 990 AVR + CABG (316 rdAVR, 674 sAVR). After inverse propensity weighting, cohorts were well matched, notable only for more patients <50 years in the sAVR group (4.0% vs 1.9%, standardized mean difference [SMD] = -0.12). Cross-clamp (89 vs 64 min, SMD = -0.71) and cardiopulmonary bypass (121 vs 91 min, SMD = -0.68) times were considerably longer for sAVR versus rdAVR. Immediate postreplacement aortic gradient decreased with larger valve size but did not differ significantly between comparable sAVR and rdAVR valve sizes or overall (6.5 vs 6.7 mm Hg, SMD = 0.09). Implanted rdAVR tended to be larger with 51% either size L or XL versus 37.4% of sAVR ≥25 mm. Despite a temporal decrease in pacemaker rate within the rdAVR cohort, the overall pacemaker frequency was less in sAVR versus rdAVR (4.4% vs 7.4%, SMD = 0.12), and significantly higher rates were seen in size L (10.3% vs 3.7%, P < 0.002) and XL (15% vs 5.6%, P < 0.004) rdAVR versus sAVR. No significant difference in major adverse cardiac events (4.6% vs 4.6%, SMD = 0.01), 30-day survival (1.5% vs 2.6%, SMD = 0.08), or long-term survival out to 4 years were seen between sAVR and rdAVR. CONCLUSIONS: Rapid deployment valves offer a safe alternative to sAVR with significantly decreased cross-clamp and cardiopulmonary bypass times. Despite larger implantation sizes, we did not appreciate a comparative difference in immediate postoperative gradients, and although pacemaker rates are improving, they remain higher in rdAVR compared with sAVR. Longer-term hemodynamic and survival follow-up are needed.

Bicuspid Morphology and Rapid Deployment Valve Replacement: Is This Still a Contraindication?

When using rapid deployment surgical aortic valve replacement (RD SAVR) in treating bicuspid aortic valve morphology (BAV), several challenges are faced due to annular asymmetry. The Sievers classification has been traditionally used for the description of BAV morphology. In this study, we aimed to conduct a retrospective feasibility analysis of RD SAVR in relation to the Sievers classification. From January 2014 to March 2022, 31 patients with BAV morphology (15 patients with Sievers type 0 BAV and 16 with Sievers type 1 BAV) underwent RD SAVR. Specific surgical techniques were applied depending on the BAV morphology. Comparable clinical outcomes were observed. No paravalvular leaks and no valvular re-interventions occurred in either group. CPB and cross-clamping times, as well as the prosthesis sizes used, were also not significantly different. Postoperative mean gradients were comparable in both groups. No significant distinction was found between the groups in terms of postoperative pacemaker indication, postoperative stroke, or death. Annular symmetry can be adequately restored through precise prosthesis sizing and placement according to an individual's valve morphology regardless of the Sievers classification of BAV by choosing a different landmark for the initial suture. RD SAVR seems to be a safe approach for any bicuspid morphology, with good hemodynamic results and time-saving potential in experienced hands.

Outcomes of rapid deployment aortic valve replacement with concomitant cardiac procedures.

Background: Rapid deployment aortic valve replacement (RD-AVR) has been recently introduced with encouraging results. Outcomes of isolated RD-AVR include good hemodynamic profile, facilitation of minimally invasive techniques, and reduction of surgical times. However, role of this prosthesis in concomitant surgery is not well known. Methods: In 2016, we formed a registry to monitor the introduction of this prosthesis, RApid Deployment Aortic Replacement (RADAR). We aim to report mid-term outcomes focusing on patients who had RD-AVR combined with other surgical procedures. Results: Between July 2012 and February 2021, 370 patients were included in this registry (mean age, 75.8±8.0 years; 64.32% male; mean EuroSCORE II, 3.5±2.8). Of these, 128 (34.59%) had concomitant procedures including myocardial revascularization surgery in 69 patients (53.91%), surgery on the ascending aorta in 34 (26.56%), and procedures on other valves in 10 patients (7.81%). There were no significant differences between the isolated AVR and concomitant AVR groups in postoperative complications, in-hospital mortality (4.72% vs. 3.32%, P=0.524), or hemodynamic behavior of these prostheses. Three-year survival was 83.73% and 89.89% in the isolated and concomitant AVR group respectively. There was no difference in survival between the two groups (log-rank test, P=0.4124). Conclusions: Our results support the safety and efficacy of the Edwards INTUITY valve system even in complex aortic valve disease with additional cardiac procedures. RD-AVR could become a useful tool for concomitant surgeries where surgical times are expected to be prolonged.

Rapid-deployment aortic valve replacement during challenging aortic valve reoperation: a case report.

A previously implanted stenotic aortic valve bioprosthesis with stenotic coronary ostia and intramyocardial calcium was surgically debrided resulting in disruption of the left outflow track. A rapid-deployment aortic valve bioprosthesis was implanted to cover the remnant aortic valve annulus, ensure open coronary ostia, and secure a well-functioning aortic valve bioprosthesis with low postoperative gradient.

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

Background: 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. Methods: 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. Results: 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. Conclusion: 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.

Predictors of New and Persistent New Left Bundle Branch Block One Year after the Implantation of a Sutureless and Rapid-Deployment Aortic Valve Prosthesis.

INTRODUCTION: Conduction disorders following aortic valve replacement therapy (AVR), either surgical or percutaneous, are related to a higher risk of complete atrioventricular block and permanent pacemaker implantation (PPI). AIM: The objective of this study was to assess risk factors regarding the incidence of new postoperative and persistent new left bundle branch block (LBBB) 1 year after the implantation of a sutureless/rapid-deployment (SURD) aortic valve prosthesis. MATERIAL AND METHODS: The current study included 200 consecutive patients treated with isolated or concomitant AVR between May 2014 and May 2017 at the Department of Cardiac Surgery in Pasawa with SURD aortic valve EDWARDS INTUITY EliteTM implantation. The patients were divided according to the presence of new postoperative LBBB (67 patients, 33.5%) and persistent new LBBB 1 year after AVR (35 patients, 17.5%). A comparative analysis was performed between patients with and without new LBBB after AVR and those with and without persistent LBBB 1 year after AVR. Univariate and multivariate regression analyses were conducted to extract the risk factors of LBBB occurrence. RESULTS: Among the risk factors for the lack of new LBBB development after AVR, Euroscore II (p < 0.001) was found, while for the occurrence of persistent new LBBB 1 year after AVR, atrial fibrillation (p = 0.001), length of hospital stay (p = 0.001) and body mass index (p = 0.004) were noted. CONCLUSIONS: Patients with new or persistent new LBBB 1 year after AVR had lower mean Euroscore II and BMI values. Their stay at the hospital was also shorter.

Rapid deployment versus its conventional counterpart in aortic valve replacement: comparison of early hemodynamic outcomes.

Background: Edwards Intuity is designed for rapid deployment based on the structure of Magna Ease. This study was conducted to compare early hemodynamic performance between the two valves. Methods: Patients who underwent aortic valve replacement (AVR) using Edwards Intuity or Carpentier-Edwards PERIMOUNT Magna Ease in our institution from June 2016 to July 2021 were enrolled. Intuity valve was used in 215 patients, and Magna Ease valve was used in 198 patients, respectively. Early postoperative echocardiographic data were available in 99.0% (409/413) of the patients. The transvalvular mean pressure gradient, effective orifice area, and effective orifice area index were compared between the valves stratified by prosthesis size. Results: There were no differences in the proportion of female patients or body surface area between the groups. Mean pressure gradient on early postoperative echocardiography was significantly lower in Intuity valve than Magna Ease valve for 19, 21, 23, and 25 mm valves (15.5±5.0 vs. 20.8±9.1 mmHg, P=0.004; 12.7±4.2 vs. 15.6±5.3 mmHg, P=0.001; 11.5±3.3 vs. 13.4±5.8 mmHg, P=0.034; and 9.9±3.1 vs. 12.3±4.0 mmHg, P=0.029; respectively). Effective orifice area was larger in Intuity valve than Magna Ease valve for 19 mm valve (1.45±0.38 vs. 1.19±0.28 cm2, P=0.002), and effective orifice area index was also larger in Intuity valve than Magna Ease valve for 19 mm valve (0.96±0.26 vs. 0.80±0.20 cm2/m2, P=0.005). Early clinical outcomes, including operative mortality and postoperative complications, demonstrated no significant differences between the groups. Conclusions: Edwards Intuity demonstrated superior early hemodynamic performance compared with Magna Ease in a size-by-size comparison, and this superiority was more definite for small prostheses.

Sutureless and Rapid Deployment vs. Transcatheter Valves for Aortic Stenosis in Low-Risk Patients: Mid-Term Results.

BACKGROUND: Recent trials showed that TAVI is neither inferior nor superior to surgical aortic valve replacement. The aim of this study was to evaluate the outcomes of Sutureless and Rapid Deployment Valves (SuRD-AVR) when compared to TAVI in low surgical risk patients with isolated aortic stenosis. METHODS: Data from five European Centers were retrospectively collected. We included 1306 consecutive patients at low surgical risk (EUROSCORE II < 4) who underwent aortic valve replacement by means of SuRD-AVR (n = 636) or TAVI (n = 670) from 2014 to 2019. A 1:1 nearest-neighbor propensity-score was performed, and two balanced groups of 346 patients each were obtained. The primary endpoints of the study were: 30-day mortality and 5-year overall survival. The secondary endpoint was 5-year survival freedom from major adverse cardiovascular and cerebrovascular events (MACCEs). RESULTS: Thirty-day mortality was similar between the two groups (SuRD-AVR:1.7%, TAVI:2.0%, p = 0.779), while the TAVI group showed a significantly lower 5-year overall survival and survival freedom from MACCEs (5-year matched overall survival: SuRD-AVR: 78.5%, TAVI: 62.9%, p = 0.039; 5-year matched freedom from MACCEs: SuRD-AVR: 64.6%, TAVI: 48.7%, p = 0.004). The incidence of postoperative permanent pacemaker implantation (PPI) and paravalvular leak grade ≥ 2 (PVL) were higher in the TAVI group. Multivariate Cox Regression analysis identified PPI as an independent predictor for mortality. CONCLUSIONS: TAVI patients had a significantly lower five-year survival and survival freedom from MACCEs with a higher rate of PPI and PVL ≥ 2 when compared to SuRD-AVR.

Perceval valve intermediate outcomes: a systematic review and meta-analysis at 5-year follow-up.

OBJECTIVES: New technologies for the treatment of Aortic Stenosis are evolving to minimize risk and treat an increasingly comorbid population. The Sutureless Perceval Valve is one such alternative. Whilst short-term data is promising, limited mid-term outcomes exist, until now. This is the first systematic review and meta-analysis to evaluate mid-term outcomes in the Perceval Valve in isolation. METHODS: A systematic literature review of 5 databases was performed. Articles included evaluated echocardiographic and mortality outcomes beyond 5 years in patients who had undergone Perceval Valve AVR. Two reviewers extracted and reviewed the articles. Weighted estimates were performed for all post-operative and mid-term data. Aggregated Kaplan Meier curves were reconstructed from digitised images to evaluate long-term survival. RESULTS: Seven observational studies were identified, with a total number of 3196 patients analysed. 30-day mortality was 2.5%. Aggregated survival at 1, 2, 3, 4 and 5 years was 93.4%, 89.4%, 84.9%, 82% and 79.5% respectively. Permanent pacemaker implantation (7.9%), severe paravalvular leak (1.6%), structural valve deterioration (1.5%), stroke (4.4%), endocarditis (1.6%) and valve explant (2.3%) were acceptable at up to mid-term follow up. Haemodynamics were also acceptable at up mid-term with mean-valve gradient (range 9-13.6 mmHg), peak-valve gradient (17.8-22.3 mmHg) and effective orifice area (1.5-1.8 cm2) across all valve sizes. Cardiopulmonary bypass (78 min) and Aortic cross clamp times (52 min) were also favourable. CONCLUSION: To our knowledge, this represents the first meta-analysis to date evaluating mid-term outcomes in the Perceval Valve in isolation and demonstrates good 5-year mortality, haemodynamic and morbidity outcomes. KEY QUESTION: What are the mid-term outcomes at up to 5 years follow up in Perceval Valve Aortic Valve Replacement? KEY FINDINGS: Perceval Valve AVR achieves 80% freedom from mortality at 5 years with low valve gradients and minimal morbidity. KEY OUTCOMES: Perceval Valve Aortic Valve Replacement has acceptable mid-term mortality, durability and haemodynamic outcomes.

Conduction Disorders And Their Clinical Impact After Sutureless/Rapid Deployment Aortic Bioprosthesis.

INTRODUCTION: Aortic stenosis remains the number one heart valve pathology. The drive to improve the surgical outcomes brought to focus rapid deployment valves (RDV), which reduce aortic cross-clamping and cardio-pulmonary bypass (CPB) times. However, some centers have reported a higher rate of conduction abnormalities and permanent pacemaker (PPM) implantation. The aim of this study was to investigate the incidence of conduction abnormalities after aortic valve replacement with RDV, as well as its impact on immediate postoperative outcomes. METHODS: Retrospective analysis of associated conductions disorders and PPM implantation rates, as well as post-operative outcomes of all patients undergoing isolated aortic valve replacement between April 2014 and December 2019 with an RDV. Comparative analysis between the group with PPM implantation and the one with no PPM implantation. Patients with previous PPM implantation, reoperations and patients with missing pre or postoperative ECG data were excluded. RESULTS: We studied 201 patients. The majority of conduction abnormalities were left bundle branch block (54,0%). Twenty-six PPM were implanted (12,6%). Pre-operative characteristic between the groups were similar and little differences were found in regard to most complications. However, the PPM group showed significantly higher rates of stroke (7.7% vs 0.0%, p=0.016) and hemodynamic support for longer than 24 hours (60.0% vs 36.1%, p=0.028). From the multivariable analysis, preoperative right bundle branch block was the only independent risk factor associated with PPM. CONCLUSIONS: PPM implantation rates with RDV are relatively high and are associated with prolonged hospital and ICU stays, postoperative stroke rates and requirement of aminergic support. Their use should be made on a case-by-case basis taking into consideration the existence of preoperative conduction disorders, especially right bundle branch block.

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.

Conduction Disorders after Surgical Aortic Valve Replacement Using a Rapid Deployment Aortic Valve Prosthesis: Medium-Term Follow-Up.

BACKGROUND: We have previously reported that the incidence of postoperative conduction disorders, especially left bundle branch block (LBBB), after implantation of a rapid deployment Intuity™ Elite aortic valve prosthesis (Edwards Lifesciences, Irvine, CA, USA), was significantly increased compared with conventional aortic valve replacement. We were now interested in how these disorders behaved at intermediate follow-up. METHODS: All 87 patients who had undergone surgical aortic valve replacement (SAVR) using the rapid deployment Intuity™ Elite prosthesis and were shown to have conduction disorders at the time of hospital discharge were followed up after surgery. These patients' ECGs were recorded at least 1 year after surgery, and the persistence of the new postoperative conduction disorders was assessed. RESULTS: At hospital discharge, 48.1% of the patients had developed new postoperative conduction disorders, with LBBB being the predominant conduction disturbance (36.5%). At medium-term follow-up (526 days, standard deviation (SD) = 169.6, standard error (SE) = 19.3 days, respectively), 44% of the new LBBB and 50% of the new right bundle branch block (RBBB) had disappeared. There was no new atrio-ventricular block III (AVB III) that occurred. One new pacemaker (PM) was implanted during follow-up because of AVB II Mobitz type II. CONCLUSIONS: At medium-term follow-up after the implantation of a rapid deployment Intuity™ Elite aortic valve prosthesis, the number of new postoperative conduction disorders, especially LBBB, has considerably decreased but remains high. The incidence of postoperative AV block III remained stable.

Pearls, pitfalls, and surgical indications of the Intuity TM heart valve: A rapid deployment bioprosthesis. A systematic review of the literature.

OBJECTIVES: To highlight short- and long-term clinical outcomes of the Intuity TM rapid deployment prosthesis for surgical aortic valve replacement. METHODS: We reviewed on PubMed/MEDLINE, Embase, SciELO, LILACS, CCTR/CENTRAL, and Google Scholar for clinical trials, retrospective clinical studies, meta-analysis, and gray literature. RESULTS: Fourty-five clinical studies with 12.714 patients were included in the analysis. Thirty-day mortality ranged from 3.8% for Intuity and 3.9% for transcatheter aortic valve replacement (TAVR). The incidence of paravalvular leak (PVL) (Intuity 0% and TAVR 2.17%), permanent pacemaker implantation (Intuity 11.11% and TAVR 12.5%), stroke (Intuity 2.2% and TAVR 2.6%), myocardial infarction (MI) (Intuity 0% and TAVR 1%), were all higher in the TAVR group. Compared to other sutured bioprosthesis (SB), mortality ranged from 0% to 3.9% for Intuity and 0%-6.9% for SB. Long-term cardiac mortality ranged from 0.9% to 1.55% for Intuity and 1.4%-3.3% for the Perceval valve. The incidence of PVL (Intuity 0.24%-0.7% and Perceval 0%-1%), endocarditis (Intuity 0.2%-0.7% and Perceval 1.6%-6.6%), stroke (Intuity 0.36%-1.4% and Perceval 0%-0.8%), MI (Intuity 0.07%-0.26%), and SVD (Intuity 0.12%-0.7% and Perceval 0%) were comparable. Compared to standard full sternotomy (SFS), minimally invasive surgery (MINV) mortality ranged from 0% to 4.3% for MINV and 0%-2.1% for SFS. Hospital costs outcomes ranged from $37,187-$44,368 for the Intuity, $69,389 for TAVR, and $13,543 for SB. Intuity short-term mortality ranged between 0.9% and 12.4% while long-term mortality ranged between 2.6% and 20%. CONCLUSIONS: This manuscript provides a 360° overview of the current rapid deployments, sutureless, and TAVR prosthesis.