Sutureless Valve Research Articles

An alternative approach for complicated prosthetic aortic valve endocarditis

BackgroundSurgical treatment of prosthetic valve endocarditis (PVE) with destruction of the aortic root and aortomitral continuity is demanding even in experienced hands.Case presentationHerein, we describe a case of a 71-year-old female patient who presented with PVE that was further complicated by a fistulous abscess cavity. The patient underwent removal of the dehisced prosthetic valve, radical annular debridement, reconstruction of the aortomitral curtain with a pericardial patch as a patch exclusion technique and implantation of a sutureless valve.ConclusionPatch exclusion technique, followed by sutureless valve implantation, might represent a feasible and safe alternative for the surgical treatment of complicated PVE.

A pooled analysis of pacemaker implantation after Perceval sutureless aortic valve replacement.

We performed a literature meta-analysis to estimate the rate of pacemaker implantation after Perceval sutureless aortic valve replacement. Pertinent articles were identified from the PubMed, Google Scholar, Ovid MEDLINE and Ovid EMBASE databases. Eligible studies reported the de novo incidence of postoperative pacemaker implantation after Perceval valve surgery. Among 394 articles retrieved, 26 studies including 9492 patients met the inclusion criteria. The pooled event rate for postoperative pacemaker implantation was 7% [95% confidence interval (CI) 6-9%]; however, significant heterogeneity was observed across studies. In a sub-analysis, there was no difference between the rates of pacemaker implantation calculated from multicentre and registry studies (8 studies, 6845 patients; 7%, 95% CI 5-10%) and single-centre studies (18 studies, 2647 patients; 7%, 95% CI 5-9%; P = 0.75). Implantation rates were similar in high-volume studies (16 studies, 9121 patients; 7%, 95% CI 5-8%) than in low-volume studies (10 studies, 371 patients; pooled rate: 7%, 95% CI 4-14%; P = 0.5). Postoperative pacemaker implantation rates tended to decrease over time. With a pooled event rate of 7%, postoperative pacemaker implantation remains an important limitation of Perceval sutureless valve surgery, although we observed a degree of variability across included studies. The resultant findings provide a useful estimate for physicians and patients and can serve as a benchmark for future comparative studies. CRD42020188397.

Minimally invasive aortic valve replacement: short-term efficacy of sutureless compared with stented bioprostheses.

Sutureless aortic valve prostheses have been introduced to facilitate the implant process, speed up the operating time and improve haemodynamic performance. The goal of this study was to assess the potential advantages of using sutureless prostheses during minimally invasive aortic valve replacement in a large multicentre population. From 2011 to 2019, a total of 3402 patients in 11 hospitals underwent isolated aortic valve replacement with minimal access approaches using a bioprosthesis. A total of 475 patients received sutureless valves; 2927 received standard valves. The primary outcome was the incidence of 30-day deaths. Secondary outcomes were the occurrence of major complications following procedures performed with sutureless or standard bioprostheses. Propensity matched comparisons was performed based on a multivariable logistic regression model. The annual number of sutureless valve implants increased over the years. The matching procedure paired 430 sutureless with 860 standard aortic valve replacements. A total of 0.7% and 2.1% patients with sutureless and standard prostheses, respectively, died within 30 days (P = 0.076). Cross-clamp times [48 (40-62) vs 63 min (48-74); P = 0.001] and need for blood transfusions (27.4% vs 33.5%; P = 0.022) were lower in patients with sutureless valves. No difference in permanent pacemaker insertions was observed in the overall population (3.3% vs 4.4% in the standard and sutureless groups; P = 0.221) and in the matched groups (3.6% vs 4.7% in the standard and sutureless groups; P = 0.364). The use of sutureless prostheses is advantageous and facilitates the adoption of a minimally invasive approach, reducing cardiac arrest time and the number of blood transfusions. No increased risk of permanent pacemaker insertion was observed.

Fifty years of the pericardial valve: Long-term results in the aortic position.

It is now 50 years since the development of the first pericardial valve in 1971. In this time significant progress has been made in refining valve design aimed at improving the longevity of the prostheses. This article reviews the current literature regarding the longevity of pericardial heart valves in the aortic position. Side by side comparisons of freedom from structural valve degeneration are made for the valves most commonly used in clinical practice today, including stented, stentless, and sutureless valves. Strategies to reduce structural valve degeneration are also discussed including methods of tissue fixation and anti-calcification, ways to minimise mechanical stress on the valve, and the role of patient prosthesis mismatch.

Sutureless Valve in Repeated Aortic Valve Replacement: Results from an International Prospective Registry.

To report early and midterm results registry of patients undergoing repeated aortic valve replacement (RAVR) with sutureless prostheses from an international prospective registry (SURE-AVR). Between March 2011 and June 2019, 69 patients underwent RAVR with self-expandable sutureless aortic bioprostheses at 22 international cardiac centers. Overall mortality was 2.9% with a predicted logistic EuroSCORE II of 10.7%. Indications for RAVR were structural valve dysfunction (84.1%) and infective prosthetic endocarditis (15.9%) and were performed in patients with previously implanted bioprostheses (79.7%), mechanical valves (15.9%), and transcatheter valves (4.3%). Minimally invasive approach was performed in 15.9% of patients. Rate of stroke was 1.4% and rate of early valve-related reintervention was 1.4%. Overall survival rate at 1 and 5 years was 97% and 91%, respectively. No major paravalvular leak occurred. Rate of pacemaker implantation was 5.8% and 0.9% per patient-year early and at follow-up, respectively. The mean transvalvular gradient at 1-year and 5-year follow-up was 10.5 mm Hg and 11.5 mm Hg with a median effective orifice area of 1.8 cm2and 1.8 cm2, respectively. RAVR with sutureless valves is a safe and effective approach and provides excellent clinical and hemodynamic results up to 5 years.

Surgical aortic valve replacement in small aortic annulus.

Althoughaortic valve replacement (AVR) has been the standard of treatment for severe aortic stenosis, a small aortic annulus (SAA) poses significant challenges. Improvements in valve designs and evolution in surgical techniques have led to improved outcomes, however, the ideal prosthetic valve remains elusive. We performed a comprehensive literature review to discuss the surgical management of aortic stenosis, with a special focus on patients with SAA. Stentless valves and root replacement techniques have been shown to overcome the hemodynamic challenges associated with conventional stented bioprostheses, but are technically challenging and require longer cross-clamp times. Sutureless and rapid deployment valves mitigate the long operative time while maintaining the hemodynamic advantages. The use of transcatheter AVR has emerged as another reasonable alternative and has shown promise among patients with SAA, however, long-term outcomes are awaited. There is no consensus regarding the type of valve prosthesis or replacement technique among patients with SAA. Consideration of patient comorbidities and valvular anatomy is paramount in planning the optimal strategy for AVR. Further long-term clinical trials are necessary to assess outcomes and achieve progress towardthe development of the ideal prosthesis.

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

BackgroundThis 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).MethodsA 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.ResultsEight 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.ConclusionsAVR 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.

Surgical Sutureless and Sutured Aortic Valve Replacement in Low-risk Patients

BackgroundRandomized clinical trials have shown that transcatheter aortic valve replacement is noninferior to surgery in low surgical risk patients. We compared outcomes in patients treated with a sutured (stented or stentless) or sutureless surgical valve from the Evolut Low Risk Trial. MethodsThe Evolut Low Risk Trial enrolled patients with severe aortic stenosis and low surgical risk. Patients were randomized to self-expanding transcatheter aortic valve replacement or surgery. Use of sutureless or sutured valves was at the surgeons’ discretion. ResultsSix hundred eighty patients underwent surgical aortic valve implantation (205 sutureless, 475 sutured). The Valve Academic Research Consortium-2 30-day safety composite endpoint was similar in the sutureless and sutured group (10.8% vs 11.0%, P = .93). All-cause mortality between groups was similar at 30 days (0.5% vs 1.5%, P = .28) and 1 year (3.3% vs 2.6%, P = .74). Disabling stroke was also similar at 30 days (2.0% vs 1.5%, P = .65) and 1 year (2.6% vs 2.2%, P = .76). Permanent pacemaker implantation at 30 days was significantly higher in the sutureless compared with the sutured group (14.4% vs 2.9%, P < .001). Aortic valve–related hospitalizations occurred more often at 1 year with sutureless valves (9.1% vs 5.1%, P = .04). Mean gradients 1 year after sutureless and sutured aortic valve replacement were 9.9 ± 4.2 versus 11.7 ± 4.7 mm Hg (P < .001). ConclusionsAmong low-risk patients, sutureless versus sutured valve use did not demonstrate a benefit in terms of 30-day complications and produced marginally better hemodynamics but with an increased rate of pacemaker implantation and valve-related hospitalizations.

Minimally invasive redo aortic valve replacement with a sutureless valve implant.

Reoperations for a dysfunctional mechanical aortic valve prosthesis are usually performed with a repeat sternotomy. Reopening the chest may be associated with a heart structure tear, bleeding, excessive transfusion, and a possible unfavorable outcome. Experience performing a redo aortic valve replacement with a minimally invasive approach and avoiding lysis of the pericardial adhesions is growing. We describe a redo aortic valve replacement procedure performed because of subvalvular pannus formation in a patient with a mechanical prosthesis. A partial J-shaped hemisternotomy at the 3rd intercostal space was performed; the ascending aorta was exposed and the valve was replaced with a sutureless bioprosthesis. The video tutorial shows the surgical approach, cardiopulmonary bypass solutions, and sutureless valve deployment.

Minimally invasive aortic valve surgery.

Since their introduction, it has been demonstrated that minimally invasive aortic valve replacement (MIAVR) approaches are safe and effective for the treatment of aortic valve diseases. To date, the main advantage of these approaches is represented by the reduced surgical trauma, with a subsequent reduced complication rate and faster recovery. This makes such approaches an appealing choice also for frail patients [obese, aged, chronic obstructive pulmonary disease (COPD)]. The standardization of the minimally invasive techniques, together with the implementation of preoperative workup and anesthesiological intra- and post-operative care, led to an amelioration of surgical results and reduction of surgical times. Moreover, the improvement of surgical technology and the introduction of new devices such as sutureless and rapid deployment (SURD) valves, has helped the achievement of comparable results to traditional surgery. However, transcatheter technologies are nowadays more and more important in the treatment of aortic valve disease, also in low risk patients. For this reason surgeons should put new efforts for further reducing the surgical trauma in the future, even taking inspiration from other disciplines. In this review, we aim to present a review of literature evidences regarding minimally invasive treatment of aortic diseases, also reflecting our personal experience with MIAVR techniques. This review could represent a tool for a well-structured patient assessment and preoperative planning, in order to safely carrying out an MIAVR procedure with satisfactory outcomes.

Implantation of a Sutureless Valve Into a Surgically Enlarged Aortic Root: A Bailout Option

Sutureless bioprostheses such as the Sorin Perceval Valve (SPV; Sorin Group, Srl, Saluggia, Italy) have been proposed for replacing stenotic native valves within small aortic roots of geriatric patients with significant comorbidity. Their use seems as safe as that of stented bioprostheses and enables significantly reduced length of surgery. Low transprosthetic pressure gradients have been measured. Because of the radial force of its self-expandable nitinol stent, aortic annulus interruption could be a relative contraindication to SPV use. Off-label implantation of the SPV into a surgically enlarged ascending aorta was first reported in this study, as a bailout option in the presence of a tiny aortic root.

Modified Implant Technique of Perceval Sutureless Valve in Congenital Type 0 Bicuspid Valve Stenosis

The Perceval sutureless valve has gained in popularity for treating degenerative aortic valve stenosis but not for congenital type 0 bicuspid aortic valve owing to anatomic challenges. We modified implant techniques following the four principles of ECHO-an acronym for elasticity, circularity, height, and orientation-to prevent paravalvular leakage and malposition.

Recovery of conduction disorders after sutureless aortic valve replacement.

Conduction disorders and the need for permanent pacemaker (PPM) implantation after surgical aortic valve replacement are well-recognized complications. However, in the case of sutureless valve prostheses, it remains unknown whether pacemaker (PM) dependency and conduction disturbances resolve over time. Our aim was to evaluate whether conduction disorders after Perceval sutureless valve implantation recover during follow-up. Patients undergoing isolated surgical aortic valve replacement or concomitant aortic valve replacement with coronary artery bypass surgery using the Perceval sutureless valve, between January 2010 and July 2018, were included. Postoperative electrocardiogram findings were analysed to determine the incidence of new-onset left bundle branch blocks (LBBBs) and the requirement for PPM implantation. During a postoperative period of 6-18 months, electrocardiogram findings during PM checks were analysed to determine PM dependency and LBBB persistence. Out of 184 patients who received a Perceval prosthesis during the study period, 39 (21.2%) patients developed new-onset LBBB and 10 patients (5.4%) received a PPM postoperatively. The occurrence of conduction disorders was not associated with valve size. Follow-up was completed in 176 (95.7%) patients. In patients with a new-onset LBBB, 35.9% recovered during follow-up (P = 0.001). Seven out of 10 (70%) patients remained PM dependent. After Perceval aortic valve implantation, new-onset LBBB recovers in more than one-third of patients during follow-up. In patients who needed a postoperative PPM, the majority remained PM dependent.

Midterm outcomes with a sutureless aortic bioprosthesis in a prospective multicenter cohort study

ObjectiveThe objective of this study was to report midterm clinical outcomes with a self-expandable sutureless aortic valve. MethodsBetween 2010 and 2013, 658 patients at 25 European institutions received the Perceval sutureless valve (LivaNova Plc, London, United Kingdom). Mean follow-up was 3.8 years; late cumulative follow-up was 2325.2 patient-years. ResultsThe mean age of the population was 78.3 ± 5.6 years and 40.0% (n = 263) were 80 years of age or older; mean Society of Thoracic Surgeons-Predicted Risk of Mortality score was 7.2 ± 7.4. Concomitant procedures were performed in 31.5% (n = 207) of patients. Overall duration of cardiopulmonary bypass time was 64.8 ± 25.2 minutes and aortic cross-clamping time was 40.7 ± 18.1 minutes. Thirty-day all-cause mortality was 3.7% (23 patients), with an observed:expected ratio of 0.51. Overall survival was 91.6% at 1 year, 88.5% at 2 years, and 72.7% at 5 years. Peak and mean gradients remained stable during follow-up, and were 17.8 ± 11.3 mm Hg and 9.0 ± 6.3 mm Hg, respectively, at 5 years. Preoperatively, 33.4% of those who received the Perceval valve (n = 210) were in New York Heart Association functional class I or II versus 93.1% (n = 242) at 5 years. ConclusionsThis series, representing, to our knowledge, the longest follow-up with sutureless technology in a prospective, multicenter study, shows that aortic replacement using sutureless valves is associated with low mortality and morbidity and good hemodynamic performance.

Early pacemaker insertion after aortic valve replacement with Edwards Intuity sutureless valve versus standard bioprosthesis

In patients undergoing aortic valve replacement the occurrence of postoperative conduction disorders is a serious adverse event, which may prolong the duration of hospitalisation and require insertion of a pacemaker. To evaluate the rate of pacemaker insertion after implantation of an Intuity sutureless aortic valve compared to standard surgical bioprosthesis. This retrospective, monocentric study included patients who underwent aortic valve replacement with an Intuity sutureless aortic valve or a standard bioprosthetic valve between June 4, 2014 and June 27, 2016. The main assessment criterion was the rate of postoperative pacemaker insertion. Secondary assessment criteria included the rate of de novo conduction disorders, the rate of atrial arrhythmia or paroxysmal conduction disorders, mortality and duration of hospitalisation. Ninety-three patients received an Intuity sutureless aortic valve (median age: 76 [71,80] years) and 176 were implanted with a standard biological aortic valve (median age: 73 [68,79] years; P = 0.007). The rate of postoperative pacemaker insertion, after adjustment, was 22.5% in the Intuity group and 5.7% in the standard aortic valve group (OR = 5.5 [95% CI: 1.37–34.54]; P = 0.036). The main indications for postoperative pacemaker insertion were complete atrioventricular block and de novo left bundle branch block (LBBB) with slowing of the infra-hisian conduction velocity. The rate of postoperative de novo bundle branch block was higher in patients implanted with an Intuity valve (OR = 6.25 [2.01–24.74]; P = 0.042). Higher rates of pacemaker insertion and de novo bundle branch block were observed in patients implanted with an Intuity sutureless bioprosthesis compared to those who received a standard surgical aortic valve.

Early and Two-year Outcomes after Sutureless and Conventional Aortic Valve Replacement: a Nationwide Population-based Study.

BackgroundWe compared early and 2-year clinical outcomes of sutureless aortic valve replacement (SAVR) with conventional aortic valve replacement (CAVR) in a nationwide study based on claims data.MethodsFrom December 2016 to November 2018, 3,173 patients underwent bioprosthetic aortic valve replacements. SAVR and CAVR were performed in 641 and 2,532 patients, respectively. Propensity score-matched analysis was performed in 640 patient pairs.ResultsOperative mortality rate was 2.8% without significant differences between the SAVR (3.4%) and CAVR (2.3%) groups (P = 0.324). There were no significant differences in postoperative morbidities between the groups except for permanent pacemaker (PPM) implantation. PPM implantation rate was significantly higher in the SAVR (3.8%) than in the CAVR group (0.9%) (P < 0.001). One- and two-year overall survival was 89.1% and 87.5%, respectively, without significant differences between the groups (SAVR group vs. CAVR group = 89.9% and 90.5% vs. 87.2% and 88.7%, respectively; P = 0.475). There were no significant differences in the cumulative incidence of cardiac death, stroke, aortic valve reoperation and infective endocarditis between the groups. Cumulative PPM implantation incidence at 6 months in the CAVR was 1.1%, and no patient required PPM implantation after 6 months. In the SAVR, the cumulative PPM implantation incidence at 0.5, one, and two years was 3.9%, 5.0% and 5.6%, respectively. The cumulative PPM implantation rate was higher in the SAVR group than in the CAVR group (P < 0.001).ConclusionEarly and 2-year clinical outcomes between SAVR and CAVR were not different except for a high rate of permanent pacemaker implantation in the SAVR group.

Perceval Sutureless Valve Associated Thrombocytopaenia: What is the Clinical Significance?

The Perceval tissue sutureless valve (PV) is a common biological prosthesis used for aortic valve replacement (AVR). Studies have identified an association with post-operative thrombocytopaenia. This study will examine a single surgeon’s early experience with this valve by comparing it to the Edwards Lifesciences tissue aortic valve (EV).

R21 Aortic Valve Replacement Using Stented or Sutureless Prosthesis via Either Full-Sternotomy or a Minimally Invasive Approach: A Metwork Meta-analysis

In the era of transcatheter aortic valve replacement (TAVI), new technologies such as sutureless prosthetic valves and access via minimally-invasive incisions reduce surgical trauma for patients undergoing surgical aortic valve replacement (SAVR). Whether a reduction in cardiopulmonary bypass and aortic cross-clamp times or avoiding complete sternotomy offer improved early postoperative outcomes is unknown.

Minimally invasive aortic valve surgery in obese patients: Can the bigger afford the smaller?

Ministernotomy and right minithoracotomy are well-known minimally invasive approaches for aortic valve replacement (AVR); however, controversial opinions exist for their utilization in obese patients. The aim of this study is to check a potential positive role of minimally invasive surgery in this population. From January 2010 to November 2019, 613 obese patients (defined by a body mass index ≥30) underwent isolated AVR at our institution. Surgical approach included standard median sternotomy (176 patients), partial upper sternotomy (271 patients), or right anterior minithoracotomy (166 patients). Intra- and postoperative data were retrospectively collected. Patients treated with minimally invasive approaches had shorter cardiopulmonary bypass time (p = .012) and aortic cross-clamp time (p = .022), mainly due to the higher utilization of sutureless valve implantation. They also presented advantages in terms of reduced postoperative ventilation time (p = .010), incidence of wound infection (p = .009), need of inotropic support (p = .004), and blood transfusion (p = .001). The univariable logistic regression showed the traditional full sternotomy approach as compared with ministernotomy (p = .026), active smoking (p = .009), peripheral vascular disease (p = .003), ejection fraction (p = .026), as well Logistic European system for cardiac operative risk evaluation (EuroSCORE; p = .015) as factors associated with hospital mortality. The multivariable logistic regression adjusted for the logistic EuroSCORErevealed that surgical approaches do not influence hospital mortality. Obese patients with severe aortic valve pathology can be treated with minimally invasive approaches offering a less biological insult andreduced postoperative complications, but without impact on hospital mortality.

Sutureless versus conventional bioprostheses for aortic valve replacement in severe symptomatic aortic valve stenosis

ObjectiveSutureless aortic valves are a novel option for aortic valve replacement. We sought to demonstrate noninferiority of sutureless versus standard bioprostheses in severe symptomatic aortic stenosis. MethodsThe Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement is a prospective, randomized, adaptive, open-label trial. Patients were randomized (March 2016 to September 2018) to aortic valve replacement with a sutureless or stented valve using conventional or minimally invasive approach. Primary outcome was freedom from major adverse cerebral and cardiovascular events (composite of all-cause death, myocardial infarction, stroke, or valve reintervention) at 1 year. ResultsAt 47 centers (12 countries), 910 patients were randomized to sutureless (n = 453) or conventional stented (n = 457) valves; mean ages were 75.4 ± 5.6 and 75.0 ± 6.1 years, and 50.1% and 44.9% were female, respectively. Mean ± standard deviation Society of Thoracic Surgeons scores were 2.4 ± 1.7 and 2.1 ± 1.3, and a ministernotomy approach was used in 50.4% and 47.3%, respectively. Concomitant procedures were performed with similar rates in both groups. Noninferiority was demonstrated for major adverse cerebral and cardiovascular events at 1 year, whereas aortic valve hemodynamics improved equally in both groups. Use of sutureless valves significantly reduced surgical times (mean extracorporeal circulation times: 71.0 ± 34.1 minutes vs 87.8 ± 33.9 minutes; mean crossclamp times: 48.5 ± 24.7 vs 65.2 ± 23.6; both P < .0001), but resulted in a higher rate of pacemaker implantation (11.1% vs 3.6% at 1 year). Incidences of perivalvular and central leak were similar. ConclusionsSutureless valves were noninferior to stented valves with respect to major adverse cerebral and cardiovascular events at 1 year in patients undergoing aortic valve replacement (alone or with coronary artery bypass grafting). This suggests that sutureless valves should be considered as part of a comprehensive valve program.