An Analysis of Early Results after Valve Replacement in Isolated Aortic Valve Stenosis by Using Sutureless vs. Stented Bioprostheses: A Single-Center Middle-Income Country Experience.

Background and Objectives: There is a lack of data about the survival of patients after the implantation of sutureless relative to stented bioprostheses in middle-income settings. The objective of this study was to compare the survival of people with isolated severe aortic stenosis after the implantation of sutureless and stented bioprostheses in a tertiary referral center in Serbia. Materials and Methods: This retrospective cohort study included all people treated for isolated severe aortic stenosis with sutureless and stented bioprostheses from 1 January 2018 to 1 July 2021 at the Institute for Cardiovascular Diseases "Dedinje". Demographic, clinical, perioperative and postoperative data were extracted from the medical records. The follow-up lasted for a median of 2 years. Results: The study sample comprised a total of 238 people with a stented (conventional) bioprosthesis and 101 people with a sutureless bioprosthesis (Perceval). Over the follow-up, 13.9% of people who received the conventional and 10.9% of people who received the Perceval valve died (p = 0.400). No difference in the overall survival was observed (p = 0.797). The multivariate Cox proportional hazard model suggested that being older, having a higher preoperative EuroScore II, having a stroke over the follow-up period and having valve-related complications were independently associated with all-cause mortality over a median of 2 years after the bioprosthesis implantation. Conclusions: This research conducted in a middle-income country supports previous findings in high-income countries regarding the survival of people with sutureless and stented valves. Survival after bioprosthesis implantation should be monitored long-term to ensure optimum postoperative outcomes.

Sutureless bioprosthesis for aortic valve replacement: Surgical and clinical outcomes.

BACKGROUND: Aortic valve stenosis is the most common adult valve disease in industrialized countries. The aging population and the increase in comorbidities urge the development of safer alternatives to the current surgical treatment. Sutureless bioprosthesis has shown promising results, especially in complex procedures and in patients requiring concomitant surgeries. OBJECTIVES: Assess the clinical and hemodynamic performance, safety, and durability of the Perceval® prosthetic valve. METHODS: This single-center retrospective longitudinal cohort study collected data from all adult patients with aortic valve disease who underwent aortic valve replacement with a Perceval® prosthetic valve between February 2015 and October 2020. Of the 196 patients included (mean age 77.20 ± 5.08 years; 45.4% female; mean EuroSCORE II 2.91 ± 2.20%), the majority had aortic stenosis. RESULTS: Overall mean cross-clamp and cardiopulmonary bypass times were 33.31 ± 14.09 min and 45.55 ± 19.04 min, respectively. Mean intensive care unit and hospital stay were 3.32 ± 3.24 days and 7.70 ± 5.82 days, respectively. Procedural success was 98.99%, as two explants occurred. Four valves were reimplanted due to intraoperative misplacement. Mean transvalvular gradients were 7.82 ± 3.62 mmHg. Pacemaker implantation occurred in 12.8% of patients, new-onset atrial fibrillation in 21.9% and renal replacement support was necessary for 3.1%. Early mortality was 2.0%. We report no structural valve deterioration, strokes, or endocarditis, and one successfully treated valve thrombosis. CONCLUSIONS: Our study confirms the excellent clinical and hemodynamic performance and safety of a truly sutureless aortic valve, up to a 5-year follow-up. These results were consistent in isolated and concomitant interventions, solidifying this device as a viable option for the treatment of isolated aortic valve disease.

Suspicion of intraoperative left main coronary artery extrinsic compression with Perceval® sutureless bioprosthesis.

We present an uncommon case of intraoperative transient myocardial ischemia related to suspicion of left main stem artery extrinsic compression caused by the radial force of the stent of Perceval® bioprosthesis. No other cases have been described, but some similarities can be found with extrinsic coronary compression in percutaneous pulmonary valves. Surgeons should be aware of this complication in patients with coronary anomalies or with bicuspid anatomy.

Transcatheter Aortic Valve-in-Valve Implantation Complicated by Aorto-Right Ventricular Fistula.

We describe the case of a degenerative, sutureless bioprosthetic valve (BPV) with deformation and stent infolding in a patient with elevated surgical risk. Following discussion among the heart team, balloon valve fracture was performed to facilitate deployment of an aortic valve-in-valve transcatheter heart valve. Post-procedural imaging demonstrated BPV frame protrusion and contained annular rupture, which required operative intervention. (Level of Difficulty: Intermediate.).

Sutureless and Transcatheter Aortic Valve Replacement: When Rivals Become Allies.

In recent years, sutureless aortic valve replacement (SU-AVR) and transcatheter aortic valve replacement (TAVR) have emerged as viable alternatives to standard surgical aortic valve replacement (AVR) in higher risk patients. We report 7 cases in which SU-AVR and TAVR were used as bailout procedures for each other. Between June 2011 and August 2018, 626 patients underwent SU-AVR with the Perceval S prosthesis, and 588 patients underwent TAVR at the Montreal Heart Institute. Herein, we report the cases of 7 patients who underwent both procedures within a short time frame: 3 patients who underwent SU-AVR with a Perceval prosthesis after a failed TAVR procedure, 3 patients who underwent TAVR after degeneration of a surgically implanted Perceval sutureless prosthesis, and 1 patient who was scheduled for multiple percutaneous interventions-including TAVR, right coronary angioplasty, atrial fibrillation ablation with left atrial appendage occlusion-who suffered a periprocedural complication requiring an emergent surgery, during which a Perceval sutureless prosthesis was deployed. All patients were discharged home alive. Two patients suffered a complete heart block requiring permanent pacemaker implantation. We demonstrate that SU-AVR with the Perceval S prosthesis and TAVR are complementary procedures within the therapeutic armamentarium to treat aortic valve disease in higher risk patients. Specifically, valve-in-valve TAVR is an attractive option in the setting of Perceval prosthesis degeneration, whereas SU-AVR is a useful bailout option in the context of periprocedural failure of a TAVR.

Sutureless aortic bioprosthesis replacement in elderly Asian patients with aortic stenosis: Experience in a single institution.

BACKGROUND: Sutureless aortic valve replacement (SU-AVR) has emerged as a promising alternative for the treatment of patients with aortic valve stenosis. This study aims to assess the safety and efficacy of SU-AVR in an elderly Asian population. METHODS: From June 2015 to May 2016, 15 adults with severe aortic stenosis (9 females) with a median age of 79 years underwent Perceval sutureless bioprosthesis (LivaNova, UK) implantation in a single Taiwanese institution; peri-operative recovery, clinical improvement, and valve performance were analyzed. RESULTS: Three (20%) patients underwent concomitant procedures (coronary artery bypass grafting, 1 patient; maze, 2 patients) and 6/12 (50%) patients underwent J-ministernotomy for isolated SU-AVR. Median cardiopulmonary bypass and cross-clamp time were 105 min and 69 min, respectively. All sutureless bioprosthesis were implanted successfully without conversion to a traditional valve, but 2 patients (13.3%) need intraoperative valve repositioning because of paravalvular leakage. Median extubation time and intensive care unit stay were 5 h and 2 days, respectively. One patient experienced in-hospital mortality due to sudden collapse thought secondary to high degree atrioventricular block. Serial echocardiographic evaluations were performed preoperatively and at 1, 3, and 6 months postoperatively. The final echocardiographic exams showed nothing greater than mild aortic insufficiency and the median mean trans-valvular gradient was 13.2 (range, 6.0-26.3) mmHg. CONCLUSIONS: By simplified procedure and improved hemodynamics, SU-AVR can be implanted safely in elderly Asian population with excellent valvular performance.

Transcatheter aortic valve implantation in degenerative sutureless perceval aortic bioprosthesis.

Sutureless aortic bioprostheses (SAB) are increasingly being used to provide shorter cross-clamp time. Valve-in-valve transcatheter aortic valve replacement (VIV-A) is shown to be effective and safe in the vast majority of patients with degenerated bioprosthetics, yet its' use in SAB failure is infrequent. We present a case of balloon-expandable VIV-A in an 80-year-old woman who suffered severe symptomatic aortic regurgitation in a failed Perceval S 21-mm valve. Computed tomography scan demonstrated a deformed valve. Our heart team favored a percutaneous VIV-A over reoperation due to the patients' high surgical risk. An Edwards-Sapien XT 23 mm was successfully deployed with excellent results. The patient remained asymptomatic following 6 months. As other bioprosthesis, some sutureless valves are condemned to structural valve degeneration. Because VIV-A is being established for managing degenerative bioprosthesis in high risk patients, it is cardinal to identify its role in novel degenerative sutureless valves. SAB were introduced to the clinical market only 5-7 years ago. The absence of sutures may theoretically impose risk for valve instability when adding a transcatheter sutureless valve inside the first one. Our successful experience was very reassuring. We report its feasibility because we believe it should provide support for further investigation on VIV-A within novel SAV. © 2016 Wiley Periodicals, Inc.

Mid-term follow-up after suture-less aortic heart valve implantation.

BACKGROUND: Aortic stenosis (AS) is the most common valve disease in the adult population and its prevalence increases with age. Unfortunately, older age and comorbidities significantly increase mortality, operative risk and worsen prognosis. In recent years, sutureless bioprosthesis [sutureless-aortic valve replacement (SU-AVR)] has become an alternative to standard AVR or TAVI in high-risk patients. Compared to standard AVR, the advantages of SU-AVR include shorter valve implantation, shorter aortic cross clamp (ACC) and cardiopulmonary bypass (CPB) times and higher valve EOA with more favorable hemodynamic parameters. Good early clinical and hemodynamic outcomes have been reported in several studies. However, although early SU-AVR results reported in the literature are encouraging, there are few results of long term follow-up. The aim of this study is to present long term echocardiographic hemodynamic outcomes of the Enable sutureless bioprosthesis. METHODS: The first human implantation of the Enable sutureless bioprosthesis was performed on the 13th January, 2005 by the authors of this manuscript. From that time until July 2008, 25 patients underwent isolated SU-AVR implantation. The median preoperative logistic EuroSCORE was 1.92±0.17 [standard deviation (SD)] and the STS score was 2.96±2.73. Preoperatively, 65.4% of patients were in NYHA class III or IV, the peak/mean gradient transaortic gradient was 84.6/52.1 mmHg. RESULTS: After the SU-AVR procedure, the average peak/mean aortic gradients were respectively: 12.9/7.1 mmHg at the intraoperative time; 18.1/9.5 mmHg at 3-6 months; 18.3/9.6 mmHg at 11-14 months; 16.9/9.3 mmHg at 2 years; 15.3/8 mmHg at 3 years; 13.4/7.1 mmHg at 4 years; 16.7/8.9 mmHg at 5 years follow-up. Other hemodynamic echocardiographic parameters such as LVOT diameter, LVOT peak velocity, LVOT TVI, valve peak velocity and valve TVI were stable during the follow-up period. CONCLUSIONS: In summary, sutureless bioprostheses are safe and effective treatments for valve stenosis with excellent outcomes and hemodynamic profile which remained stable during the follow-up period. The peak and mean gradients were 16.7 and 8.9 mmHg, respectively, over a 5-year follow-up period.

Sutureless aortic valve replacement versus transcatheter aortic valve implantation: a meta-analysis of comparative matched studies using propensity score matching.

OBJECTIVES: The aim of this meta-analysis was to compare outcomes of patients undergoing transcatheter aortic valve implantation (TAVI) with those undergoing surgical aortic valve replacement using sutureless valves. METHODS: A systematic review and meta-analysis in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement was performed. RESULTS: No randomized controlled trials were identified. Six comparative studies using propensity score matching met the inclusion criteria. This meta-analysis identified 1462 patients in that 731 patients underwent surgical aortic valve replacement using sutureless valves (SU) and 731 patients underwent a TAVI. The 30-day or in-hospital mortality was lower in the SU group [odds ratio (OR) 0.54, 95% confidence interval (CI) 0.36-0.80; P = 0.003]. In the TAVI group, the incidence of postoperative stroke was higher (OR 0.36, 95% CI 0.17-0.79; P = 0.01). The incidence of moderate or severe paravalvular regurgitation was higher in the TAVI group (OR 0.22, 95% CI 0.14-0.35; P = 0.001). There were neither differences in the postoperative renal failure (OR 1.44, 95% CI 0.46-4.58; P = 0.53) nor in the number of patients requiring postoperative pacemaker implantation (OR 1.06, 95% CI 0.54-2.08; P = 0.86). Patients in the SU group required more transfusions (OR 4.47, 95% CI 2.77-7.21; P = 0.0001), whereas those in the TAVI group had higher major vascular complications (OR 0.06, 95% CI 0.01-0.25; P = 0.0001). Intensive care unit stay was not different (mean difference 0.99, 95% CI - 1.22 to 1.40; P = 0.53). One-year survival was better in the SU group (Peto OR 0.35, 95% CI 0.18-0.67; P = 0.001), as was the 2-year survival (Peto OR 0.38, 95% CI 0.17-0.86; P = 0.001). CONCLUSIONS: Surgical aortic valve replacement using sutureless valves is associated with better early and mid-term outcomes compared with TAVI in high- or intermediate-risk patients.

Sutureless aortic bioprosthesis.

Aortic valve replacement (AVR) is the treatment of choice for aortic valve disease, with excellent results reported in the short- and long-term follow-up. Due to the increasing number of patient comorbidities and older age, various technical alternatives have been developed such as transcatheter aortic valve implantation and, more recently, sutureless valve bioprostheses. For patients with very high surgical risk, transcatheter implantation is becoming the top therapeutic option. However, the percutaneous technique still has major disadvantages including those related to implantation without excision of the diseased native valve without direct view of the annulus, which increases the probability of developing perivalvular leaks and a high percentage of atrioventricular block. Due to the need for aggressive crimping of pericardial layers, there is uncertainty about their long-term durability. A new technique for AVR using sutureless bioprosthesis has recently been developed. The main advantages of this technique are the excellent haemodynamic performance and fast deployment under direct view, thereby avoiding the knotting of surgical stitches, which is especially advantageous in more technically demanding procedures (e.g. minimally invasive surgery, calcified aortic root and reoperations). The good clinical results of these valves have been supported by scientific evidence, making it a feasible option for patients who are candidates for AVR using biologic prosthesis, especially for those with mid-high surgical risk for standard AVR and percutaneous transcatheter valve implantation. In this article, we review the latest evidence on these new prostheses, including their advantages and possible disadvantages.

Therapeutic alternatives after aborted sternotomy at the time of surgical aortic valve replacement in the TAVI Era-Five centre experience and systematic review.

BACKGROUND: We aimed to analyze causes, management, and outcomes of the unexpected need to abort sternotomy in aortic stenosis (AS) patients accepted for surgical aortic valve replacement (SAVR) in the transcatheter aortic valve implantation (TAVI) era. METHODS: Cases of aborted sternotomy (AbS) were gathered from 5 centers between 2009 and 2014. A systematic review of all published cases in the same period was performed. RESULTS: A total of 31 patients (71% males, 74±8years, LogEuroSCORE 11.9±7.4%) suffered an AbS (0.19% of all sternotomies). Main reasons for Abs included previously unknown porcelain aorta (PAo) in 83.9%, mediastinal fibrosis due to radiotherapy in 12.9%, and chronic mediastinitis in 3.2%. Median time between AbS and next intervention was 2.3months (IQR: 0.7-5.8) with no mortality within this period. Only a case was managed with open surgery. In 30 patients (96.8%) TAVI was performed with a rate of success of 86.7%. Three patients (9.7%) presented in-hospital death and 17 (54.8%) had in-hospital complications including heart failure (9.6%), major bleeding (6.9%), and acute kidney injury (9.6%). Older patients (76±8 vs. 70±8years, p=0.045), previous cardiac surgery (60% vs. 15.4%, p=0.029), and shorter time from AbS to next intervention (5.1±5 vs. 1±0.7months, p=0.001) were related to higher six-month mortality (22.6%). CONCLUSIONS: The main reason for AbS was PAo. This entity was associated to a higher rate of complications and mortality, especially in older patients and with prior cardiac surgery. A preventive strategy in these subgroups might be based on imaging evaluation. TAVI was the most extended therapy.

Closed chest human aortic valve removal and replacement: Technical feasibility and one year follow-up.

BACKGROUND: Minimally invasive aortic valve replacement has so far required a minithoracotomy or a ministernotomy. We present here the first series of totally endoscopic aortic valve replacement (TEAVR). METHODS: Between June 2013 and April 2015, 14 consecutive patients (12 males, mean age=76 ± 5.4 years) with a mean EuroSCORE II of 2.72 ± 0.03% underwent TEAVR. A five trocar setting was used in all patients: after ablation of the native valve, a Nitinol stented sutureless 3f Enable Medtronic valve, compressed into the main working trocar, was introduced into the thorax and then expanded in the aortic root. RESULTS: Among the 14 patients, a thoracoscopic approach was successful in 13 (92.8%) and conversion into an open surgery using the right anterior minithoracotomy was necessary to close the aortotomy in one case. Mean cross-clamping and cardiopulmonary (CPB) times were 112 ± 18 and 161 ± 31 min, respectively. All patients left the surgical unit within 8 days after the operation without any paravalvular leakage. There was no paravalvular regurgitation, conductive block or any major adverse event at a mean follow-up of 10 ± 4 months (range 2-16). CONCLUSIONS: TEAVR is feasible and safe in a selected subset of patients. Closed chest surgery has the potential to become the future approach of the isolated aortic valve replacement in low risk patients but further technical refinement and larger studies are necessary to reduce operative durations and enhance reproducibility.

Robotic total endoscopic sutureless aortic valve replacement: proof of concept for a future surgical setting.

BACKGROUND: Sutureless valves have recently enabled closed chest aortic valve replacement. This paper evaluates the feasibility of a robotic telemanipulation during thoracoscopic sutureless aortic valve implantation in cadavers. METHODS: Cadavers were prepared with a five thoracosopic trocar setting, with a transthoracic clamp inserted in the first right intercostal space and the optics inserted in the second. Seven sutureless valve implantations were scheduled using 5 Sorin Perceval and 2 Medtronic 3f Enable valves. RESULTS: In all cases performance of pericardial suspension, aortotomy and root exposure required less than 20 min. Native valve excision and sutureless bioprosthesis implantation was technically feasible in all cases. A satisfactory prosthesis sealing was ascertained visually and the absence of paravalvular leakages was assessed with a nerve hook test around the prosthetic flange. CONCLUSIONS: Closed chest and robot assisted sutureless valve implantation is feasible in cadavers. Robotic technology can enhance reproducibility of the technique. Copyright © 2015 John Wiley & Sons, Ltd.

Edwards Intuity Aortic Bioprosthesis in Patient with Bicuspid Aortic Valve.

Bicuspid aortic valve (BAV) is generally considered to be a contraindication to sutureless aortic valve replacement (AVR). Implantation of the Edwards Intuity aortic bioprosthesis is an innovative approach associated with superior hemodynamic performance, significantly reduced myocardial ischaemia and cardiopulmonary bypass times and proves to be suitable for type 1 and 2 of bicuspid aortic valves replacement. We report a case of successful AVR using a fast deployment bioprosthesis,the Edwards Intuity Valve System, in a 67-year-old woman with a bicuspid aortic valve and concomitant severe aortic stenosis.

A comparison of conventional surgery, transcatheter aortic valve replacement, and sutureless valves in "real-world" patients with aortic stenosis and intermediate- to high-risk profile.

OBJECTIVE: We sought to investigate the clinical outcomes of patients with isolated severe aortic stenosis and an intermediate- to high-risk profile treated by means of conventional surgery (surgical aortic valve replacement), sutureless valve implantation, or transcatheter aortic valve replacement in a multicenter evaluation. METHODS: Among 991 consecutive patients with isolated severe aortic stenosis and an intermediate- to high-risk profile (Society of Thoracic Surgeons score >4 and logistic European System for Cardiac Operative Risk Evaluation I >10), a propensity score analysis was performed on the basis of the therapeutic strategy: surgical aortic valve replacement (n = 204), sutureless valve implantation (n = 204), and transcatheter aortic valve replacement (n = 204). Primary end points were 30-day mortality and overall survival at 24-month follow-up; the secondary end point was survival free from a composite end point of major adverse cardiac events (defined as cardiac-related mortality, myocardial infarction, cerebrovascular accidents, and major hemorrhagic events) and periprosthetic regurgitation greater than 2. RESULTS: Thirty-day mortality was significantly higher in the transcatheter aortic valve replacement group (surgical aortic valve replacement = 3.4% vs sutureless = 5.8% vs transcatheter aortic valve replacement = 9.8%; P = .005). The incidence of postprocedural was 3.9% in asurgical aortic valve replacement vs 9.8% in sutureless vs 14.7% in transcatheter aortic valve replacement (P< .001) and peripheral vascular complications occurred in 0% of surgicalaortic valve replacement vs 0% of sutureless vs 9.8% transcatheter aortic valve replacement (P< .001). At 24-month follow-up, overall survival (surgical aortic valve replacement = 91.3% ± 2.4% vs sutureless = 94.9% ± 2.1% vs transcatheter aortic valve replacement = 79.5% ± 4.3%; P < .001) and survival free from the composite end point of major adverse cardiovascular events and periprosthetic regurgitation were significantly better in patients undergoing surgical aortic valve replacement and sutureless valve implantation than in patients undergoing transcatheter aortic valve replacement (surgical aortic valve replacement = 92.6% ± 2.3% vs sutureless = 96% ± 1.8% vs transcatheter aortic valve replacement = 77.1% ± 4.2%; P < .001). Multivariate Cox regression analysis identified transcatheter aortic valve replacement as an independent risk factor for overall mortality hazard ratio (hazard ratio, 2.5; confidence interval, 1.1-4.2; P = .018). CONCLUSIONS: The use of transcatheter aortic valve replacement in patients with an intermediate- to high-risk profile was associated with a significantly higher incidence of perioperative complications and decreased survival at short- and mid-term when compared with conventional surgery and sutureless valve implantation.