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.

Evaluation of oversizing in association with conduction disorder after implantation of a rapid deployment valve.

Rapid deployment valve has expanded surgical indication for high-risk patients with aortic stenosis despite its accommodated risk for conduction disorder (CD). The purpose of this study was to evaluate the degree of oversizing in association with postoperative CD. During June 2019 to September 2021, 25 patients underwent aortic valve replacement with Edwards INTUITY. Device size selection was evaluated intraoperatively using provided sizers. Oversizing was evaluated retrospectively by measuring the difference of the dimension of the annulus and left ventricular outflow tract (LVOT) compared to the dimensions of the device used by preoperative-computed tomography. Although there was no incidence of pacemaker implantation, seven patients (28.0%) experienced CD after surgery. There was no difference in device area and annulus area (CD: - 37 ± 22.7 mm2 vs. no CD: - 56 ± 63.6 mm2, p = 0.47), and device circumference and annulus circumference (CD: - 4.4 ± 2.77 mm vs. no CD: - 6.9 ± 5.60 mm, p = 0.26) in patients with and without CD. However, there was a significant difference in area of the device skirt and sub-annular area at the LVOT (CD: 114 ± 28.4 mm2 vs. no CD: - 8 ± 80.0 mm2, p < 0.001), and circumference of device skirt and the LVOT (CD: 3.9 ± 2.08 mm vs. no CD: - 4.6 ± 5.24 mm, p < 0.001) between the two groups. Receiver operating characteristic curve analysis showed that an area difference of 77.7 mm2 and circumference difference of 0.91 mm at LVOT were associated with postoperative CD with specificities of 0.83, 0.78 and sensitivity of 1.0, 1.0, respectively. Preoperative measurement of the LVOT may be useful in evaluating the risk of postoperative CD in patients receiving rapid deployment valve.

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

INTRODUCTION: 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. METHODS: Analysis of n=372 patients who underwent Edwards INTUITY (Edwards Lifesciences, Irvine, CA, USA) (n=251) and Perceval (Sorin/LivaNova Group, Saluggia, Italy) (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). RESULTS: A total of 372 patients (aged 75±6.3 yrs) 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 (60) patients (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. CONCLUSIONS: 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.

Minimally invasive aortic valve replacement with sutureless bioprosthesis through right minithoracotomy with completely central cannulation-Early results in 203 patients.

OBJECTIVES: Minimally invasive aortic valve replacement (mini-AVR) might improve clinical outcomes, particularly in high-risk and elderly patients. Sutureless/rapid deployment bioprosthesis can offer advantage of decreasing the cross-clamp time (XCT) and easing the procedure. Our aim was to evaluate the safety and perioperative outcomes of mini-AVR using sutureless bioprothesis via the right minithoracotomy approach with our modified technique of central cannulation. METHODS: We performed a single-center retrospective analysis of 203 patients consecutively undergoing isolated AVR between March 2016 and June 2018 with the right minithoracotomy approach and our modified technique of central cannulation. Aortic valve diseases were stenosis (89.9%), regurgitation (1.6%), and mixed valve disease (8.5%). Patients with concomitant procedures were excluded. Primary endpoints were 30-day and 4-month mortality. RESULTS: Mean age was 76 ± 6.2 years, 63 (31%) patients were 80 years or older. Cardiopulmonary bypass and XCT were 60.5 (39-153) and 35 (24-76) min, respectively. Thirty-day and 4-month mortality were 1% (two patients). We have observed minor paravalvular leak (PVL) which occurred in seven patients (3.4%), and no moderate/severe PVL was found perioperatively. One patient developed moderate/severe PVL during the 4-month follow-up. There was no structural valve degeneration. Two (1%) patients needed conversion to full sternotomy, and two (1%) patients to ministernotomy. CONCLUSIONS: Mini-AVR via the right minithoracotomy approach with central cannulation is an effective and safe procedure and demonstrates excellent early clinical outcomes. This approach can be particularly valuable in higher risk and elderly patients.

Minimally invasive aortic valve replacement: extracorporeal circulation optimization and minimally invasive extracorporeal circulation system evolution.

Treatment of aortic valve disease has become less and less invasive during the last years, thanks to progress in anesthesiology, surgical techniques, and perfusion management. In fact, it has been demonstrated that shorter skin incision, combined with ultra-fast-track anesthesia and minimized extracorporeal circuit could improve clinical outcomes. Current evidence shows that minimally invasive extracorporeal circulation system is associated with reduced red blood cells' transfusion rate, improved end-organ perfusion, decreased incidence of postoperative atrial fibrillation, air embolism leakage, and so less cerebral accidents with better neurological outcomes. Moreover, the use of a closed circuit seems to be more physiologic for the patients, reducing systemic inflammatory response due to less air-blood contact and the use of biocompatible surfaces. In the literature, the benefits of minimally invasive extracorporeal circulation are described mostly for coronary surgery but few data are nowadays available for minimally invasive extracorporeal circulation during aortic valve replacement. In this article, we describe our perfusion protocol in minimally invasive aortic valve replacement.

Composite graft using an Edwards Intuity Elite rapid deployment bioprosthesis for aortic root replacement.

We describe a technique using an Edwards Intuity Elite rapid deployment bioprosthesis to construct a composite graft for an aortic root replacement.

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.

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.

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.

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.

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.

Rapid deployment valves versus conventional tissue valves for aortic valve replacement.

OBJECTIVES: Rapid deployment valves have been developed as a means to adjust for limitations in transcatheter aortic valve replacement and surgical aortic valve replacement for the management of aortic valve disease. To date, many studies have shown that although rapid deployment valves facilitate a shorter surgical aortic valve replacement, they offer no clinical benefit. The purpose of this study was to compare the outcomes of rapid deployment valves with conventional surgical aortic valve replacement. METHODS: This study was a retrospective review of all patients undergoing tissue aortic valve replacement at a single center. The majority of patients were men and aged more than 60 years. Patients were categorized into 2 groups: (1) rapid deployment valves and (2) conventional sutured valve. Inverse probability treatment weighting method was used to create a cohort of patients with similar baseline characteristics. Kaplan-Meier curves and log-rank tests were used to determine if there were statistically significant differences in outcomes. Primary outcome was all-cause mortality at 30 days, 1 year, and 5 years. RESULTS: A total of 2237 patients made up the study population from 2013 to 2019. After inverse probability treatment weighting, there were 295 patients in each group. Shorter cardiopulmonary bypass and crossclamp times were found with the rapid deployment valves. No statistically significant difference was found in the primary and secondary outcomes. There was a significant difference in the rate of permanent pacemaker insertion with a 7% pacemaker rate in the rapid deployment valve group (P < .009). CONCLUSIONS: The data suggest that rapid deployment valves offer no benefit in straightforward aortic valve replacement, and further study will help identify which patient population the valve is suited for.

Introduction of the Rapid Deployment Aortic Valve System Use in Elderly Patients With Endocarditis.

Introduction: The rapid-deployment valve system (RDVS) was introduced to facility minimally invasive aortic valve replacement. In this study we evaluate the potential benefits of RDVS in elderly high-risk patients with endocarditis of the aortic valve. Materials and Methods: Since the introduction of RDVS in our institution in December 2017 through October 2021, EDWARDS INTUITY rapid-deployment prosthesis (Model 8300A, Edwards Lifesciences, Irvine, CA, USA) has been implanted in a total of 115 patients for different indications by a single surgeon. Out of one-hundred and fifteen cases of RDVS implantation, seven patients with a median age of 77 yrs. (range 62-84yrs.), suffered from active infective endocarditis of the aortic valve. The median EuroSCORE II of these highly selected patient cohort was 77% (range 19-80%). Patient data were evaluated perioperatively including intra-operative data as well as in-hospital morbidity/mortality and follow-up after discharge from hospital. Results: Three patients underwent previous cardiac surgery. Concomitant procedures were performed in six patients including, ascending aorta replacement (n = 3), mitral valve repair (n = 1), pulmonary valve replacement (n = 1), bypass surgery (n = 1), left atrial appendix resection (n = 1) and anterior mitral valve repair (n = 1). Median aortic cross-clamp and cardiopulmonary bypass time was 56 min (range 29-122 min) and 81 min (range 45-162 min.), respectively. Post-operative complications in these elderly high-risk patients were atrial fibrillation (n = 3) and re-exploration for pericardial effusion (n = 1). One pacemaker implantation was required on postoperative day 6 due to sick sinus syndrome. There was one in-hospital death (14%) and one during follow-up (14%). Conclusion: Rapid-deployment aortic valve system seems to be a viable option with acceptable morbidity and mortality in elderly high-risk patients with active infective endocarditis of the aortic valve.

Real-world 6-month outcomes of minimally invasive aortic valve replacement with the EDWARDS INTUITY Elite valve system.

OBJECTIVES: We report on real-world safety and performance outcomes of minimally invasive rapid-deployment aortic valve replacement using the EDWARDS INTUITY Elite aortic valve system. METHODS: The study valve system was used in a European, prospective, multicentre post-market study. Various procedural, haemodynamic and clinical outcomes were evaluated through 6 months of post-implant. RESULTS: A total of 276 patients out of 280 (98.6%) enrolments were successfully implanted with the study valve using a minimally invasive approach between February 2016 and April 2017. Of these 276 patients, 240 (87%) underwent partial sternotomy and 36 (13%) patients underwent right thoracotomy. Mean cross-clamp time was 51.9 [standard deviation (SD): 16.0] min. From baseline to 6 months, the mean effective orifice area increased from 0.8 (SD: 0.3) to 1.8 (SD: 0.6) cm2 and the mean systolic gradient decreased from 46.0 (SD: 14.1) to 8.8 (SD: 3.7) mmHg. After 6 months, 70.7% and 26.4% of patients were in New York Heart Association class I and II, respectively. Freedom from death, major bleeding, major paravalvular leak, reoperation and device explant at 6 months were 96.0%, 98.5%, 98.8%, 99.2% and 99.2%, respectively. CONCLUSIONS: These results demonstrate that the study valve is a safe and effective choice for patients undergoing aortic valve replacement via minimally invasive surgery. NAME AND REGISTRATION OF REGISTRY: MISSION (Assessing clinical outcomes using the EDWARDS INTUITY Elite Valve System in isolated AVR using Minimally InvaSive Surgery In a EurOpean multi-ceNter, active, post-market registry). clinicaltrials.gov ID #NCT02907463.

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

OBJECTIVES: 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). METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Need for permanent pacemaker implantation following implantation of the rapid deployment valve in combined procedures: a single centre cohort study.

BACKGROUND: Rapid deployment aortic valves may interfere with the cardiac conduction system. We investigated the need for permanent pacemaker implantation (PPI) following the implantation of Edwards INTUITY valve (Edwards Lifesciences, Irvine, CA). METHODS: One hundred twenty patients underwent aortic valve replacement (AVR) with the INTUITY valve in a combined procedure at the German Heart Centre Munich between April 2016 and December 2019. Twenty-four patients with prior PPI or concomitant ablation procedures (24/120, 20%) were excluded. Patient-specific, procedural and post-procedural outcomes were assessed in the remaining 96 cases. RESULTS: AVR was successful in all cases. Seventy-four percent of the study population were men. Mean age was 69.5±7.6 years. EuroSCORE II was 3.2±2.9. Forty-six patients (46/96, 47.9%) presented with pre-operative conduction disorders, right bundle branch block (RBBB) (17/96, 17.7%) and first-degree or second degree atrio-ventricular block (AVB) (18/96, 18.8%), in particular. In total, 9 patients (9/96, 9.4%) underwent PPI. PPI was required in 3 patients (3/50, 6.0%) who did not have a pre-existing conduction disorder due to new high degree AVB. 6 patients with pre-operative conduction disorders (6/46, 13%) needed PPI. Timing of PPI was 5.2±1.5 days (median 5). Independent predictors of PPI were preoperative RBBB [odds ratio (OR) =4.554, P=0.049] and large valve size (#27) (OR =5.527, P=0.031). CONCLUSIONS: The analysis of the data collected enabled us to identify patient factors associated with higher risk for post-operative PPI following AVR with the INTUITY valve. Patient factors associated with post-operative PPI, were RBBB and large valve size. These patients should be closely monitored following the procedure, in particular.

Use of Sutureless and Rapid Deployment Prostheses in Challenging Reoperations.

Sutureless and rapid-deployment bioprostheses have been introduced as alternatives to traditional prosthetic valves to reduce cardiopulmonary and aortic cross-clamp times during aortic valve replacement. These devices have also been employed in extremely demanding surgical settings, as underlined in the present review. Searches on the PubMed and Medline databases aimed to identify, from the English-language literature, the reported cases where both sutureless and rapid-deployment prostheses were employed in challenging surgical situations, usually complex reoperations sometimes even performed as bailout procedures. We have identified 25 patients for whom a sutureless or rapid-deployment prosthesis was used in complex redo procedures: 17 patients with a failing stentless bioprosthesis, 6 patients with a failing homograft, and 2 patients with the failure of a valve-sparing procedure. All patients survived reoperation and were reported to be alive 3 months to 4 years postoperatively. Sutureless and rapid-deployment bioprostheses have proved effective in replacing degenerated stentless bioprostheses and homografts in challenging redo procedures. In these settings, they should be considered as a valid alternative not only to traditional prostheses but also in selected cases to transcatheter valve-in-valve solutions.

Changes in the Prosthesis Types Used for Aortic Valve Replacement after the Introduction of Sutureless and Rapid Deployment Valves in Korea: A Nationwide Population-Based Cohort Study.

BACKGROUND: Sutureless and rapid deployment valves for aortic valve replacement (AVR) were introduced in Korea in December 2016. This study evaluated changing trends in the prosthetic valves used for AVR in Korea after the introduction of sutureless and rapid deployment valves. METHODS: From December 2016 to December 2018, 4,899 patients underwent AVR in Korea. After applying the exclusion criteria, 4,872 patients were analyzed to determine changes in the type of prosthetic valve used for AVR. The study period was divided into 5 groups corresponding to 5-month intervals. RESULTS: The total number of AVR cases was 194.88±28.78 per month during the study period. Mechanical valves were used in approximately 27% to 33% of cases, and the proportion of mechanical valve use showed a tendency to decrease, with marginal significance overall (p=0.078) and significant decreases in patients less than 60 years of age and in men (p=0.013 and p=0.023, respectively). The use of sutureless valves increased from 13.4% to 25.8% of cases (p<0.001), especially in elderly patients (>70 years) and those requiring concomitant surgery. In a comparison between sutureless and rapid deployment valves, the use of Perceval S valves (a type of sutureless valve), gradually increased (p<0.001). CONCLUSION: After the introduction of sutureless and rapid deployment valves in Korea, the rate of use of these new valves remarkably increased, especially in elderly patients and those requiring concomitant surgery. Further studies should investigate the clinical outcomes of these new prostheses.

Direct comparison of rapid deployment versus sutureless aortic valve replacement: a meta-analysis.

BACKGROUND: This meta-analysis was conducted to compare the procedural and early outcomes of aortic valve replacement (AVR) using rapid deployment valve (RD group) versus sutureless valve (SU group). METHODS: A literature search of 5 online databases was conducted. The primary outcomes were mean transvalvular pressure gradient (MPG) after AVR, the incidence of paravalvular leak (PVL) and the need for a permanent pacemaker implantation (PPI). The secondary outcomes included aortic cross-clamp (ACC) and cardiopulmonary bypass (CPB) times, early mortality and other postoperative complications, such as atrial fibrillation, bleeding reoperation and stroke. RESULTS: Eight articles were included, and all outcomes except MPG after AVR in matched valve sizes were extracted from 7 studies (RD group =842 patients and SU group =1,386 patients). The pooled analysis demonstrated a lower MPG in the RD group than in the SU group, with mean difference (MD) of 2.64 mmHg. The pooled risk ratios of any PVL and grade ≥2 (or moderate) PVL were not significantly different between the groups; however, the incidence of PPI was significantly lower in the RD group than in the SU group, with a risk ratio of 0.69. The pooled analyses showed that the ACC and CPB times were significantly longer in the RD group than in the SU group, with weighted MDs of 8.74 (P<0.001) and 9.94 (P<0.001) minutes, respectively. The risks of early mortality and other postoperative complications were not significantly different between the groups. CONCLUSIONS: AVR using RD valve was associated with better valve hemodynamics in terms of the MPG than AVR using SU valve, and better outcomes were observed in the RD group regarding PPI. Procedural times were longer in AVR using RD valve than SU valve. Early clinical outcomes showed no difference between RD and SU valve.