Sutureless valves versus aortic root enlargement for aortic valve replacement in small aortic annulus: A systematic review and pooled analysis.

BACKGROUND: Very few studies provide direct comparisons between aortic root enlargement and sutureless valve implantation in patients with a small aortic annulus who underwent aortic valve replacement. This study aims to provide comparative outcomes between the two in such a subset of patients, through a systematic review and pool analysis. METHODS: The PubMed, Scopus and Embase databases were searched using the appropriate terms. The data from original articles mentioning aortic root enlargement and sutureless valves in a single or comparative study with another group of patients with a small aortic annulus were pooled and analyzed using descriptive statistics. RESULTS: Both cardiopulmonary bypass (68.4 vs. 125.03 min, p < 0.001) and aortic cross-clamp times were significantly shorter in the sutureless valve group, along with a concomitantly higher number of minimally invasive surgeries. The incidence of permanent pacemaker implantation (9.76% vs. 3.16%, p < 0.00001), patient prosthesis mis-match and paravalvular leak was significantly higher in the sutureless valve group. In comparison, the incidence of re-exploration for bleeding was higher in the aortic root enlargement group (5.27% vs. 3.16%, p < 0.02). The two groups had no differences in the duration of hospital stays or mortality. CONCLUSIONS: Sutureless valves demonstrated a comparable hemodynamic outcome with aortic root enlargement in patients with a small aortic annulus. In addition to this, it greatly facilitated minimally invasive surgery. However, the high incidence of pacemaker implantation is still a concern for the widespread recommendation of sutureless valves, especially in young patients with a small aortic annulus.

1-year outcomes of patients implanted with the Perceval sutureless valve: the Japanese post-marketing surveillance study.

Sutureless offers an alternative to standard valves in surgical aortic valve replacement (SAVR). We sought to confirm the efficacy and safety of the Perceval sutureless valve in Japanese patients. Prospective observational study of 204 patients who underwent SAVR with Perceval at 19 sites in Japan between March and December 2019. The primary outcomes were 30-day mortality and postoperative complications; the secondary outcome was all-cause mortality at 1 year. Efficacy outcomes were changed in New York Heart Association (NYHA) class, pressure gradients, effective orifice area (EOA), EOA indexed to body surface area (EOAi) and severity of aortic regurgitation. Mean age was 77.7 years, 62.7% were female. Procedural success rate was 99.0%. The median cross-clamp and cardiopulmonary bypass times were 68.0 and 108 min. Perceval size S and M were implanted in 95 (46.6%) and in 76 (37.3%) of patients, respectively. The 30-day and late mortality rate were 0.5% and 4.4%, while the new permanent pacemaker implantation rate was 4.4%. Mean pressure gradient was 13.0 mmHg at discharge, reaching 11.0 mmHg at 1 year; while the mean EOA was 1.5 cm2 at discharge remaining stable up to 1 year. No moderate or severe leakages were present at discharge or at 1 year. NYHA class improved by ≥ 1 level in 55.1% of the patients at discharge and in 69.4% of the patients at 1 year. 1-year outcomes of SAVR with the Perceval sutureless valve in Japanese patients were favorable. This valve offers a promising alternative to conventional biological AVR in this Japanese population.

Pacemaker after Sutureless and Rapid-Deployment Prostheses: A Progress Report from the SURD-IR.

OBJECTIVES: The aim of this study was to investigate the need for postoperative permanent pacemaker implantation (PPI) following sutureless and rapid-deployment aortic valve replacement (SuRD-AVR) in the context of a progress report from a large multicenter international registry (SURD-IR). METHODS: We retrospectively analyzed 4,166 patients who underwent SuRD-AVR between 2008 and 2019. The primary outcome was the need for PPI before discharge. The study population was analyzed separately according to the implanted prostheses (Su cohort and RD cohort). Each cohort was divided into two groups based on the operation date: an early group ("EG" = 2008-2016) and a late group ("LG" = 2017-2019). RESULTS: The rate of PPI decreased significantly in the Su cohort over time (EG = 10.8% vs LG = 6.3%, p < 0.001). In the Su cohort, a decrease in age, risk profile, and incidence of bicuspid aortic valve, increased use of anterior right thoracotomy, reduction of cardiopulmonary bypass time and of associated procedures, and more frequent use of smaller prostheses were observed over time. In the RD cohort, the rate of PPI was stable over time (EG = 8.8% vs LG = 9.3%, p = 0.8). In this cohort, a younger age, lower risk profile, and higher incidence of concomitant septal myectomy were observed over time. CONCLUSION: Our analysis showed a significant decrease in the PPI rate in patients who underwent Su-AVR over time. Patient selection as well as surgical improvements and a more accurate sizing could be correlated with this phenomenon. The RD cohort revealed no significant differences either in patient's characteristics or in PPI rate between the two time periods.

Application of sutureless technique in total anomalous pulmonary venous connection repair.

The sutureless technique was initially used for the treatment of postoperative pulmonary vein obstruction (PVO) in patients with total anomalous pulmonary venous connection (TAPVC). However, as the effectiveness of the sutureless technique has been confirmed and widely developed, the sutureless technique has been used for the primary treatment of high-risk children with TAPVC who are at high risk of PVO. Compared with traditional surgery, the sutureless technique significantly reduces the incidence of postoperative PVO, re-intervention rate due to PVO, and postoperative mortality, but there are potential complications such as pericardial and confluent venous anastomosis, phrenic nerve damage, air embolism. In addition, the sutureless technique is not effective in dealing with the progressive stenosis of the pulmonary veins after sutureless surgery and diffuse stenosis of extrapulmonary proximal veins and intrapulmonary veins. These make the efficacy and safety of this procedure controversial. This paper reviews the research status of the sutureless technique in TAPVC repair at home and abroad over the years.

Sutureless versus transcatheter aortic valves in elderly patients with aortic stenosis at intermediate risk: A multi-institutional study.

OBJECTIVE: This multi-institutional study compares the long-term outcome of elderly patients with severe aortic stenosis and an intermediate risk profile undergoing sutureless versus transcatheter aortic valve implantation. METHODS: From 2008 to 2015, 967 elderly patients (>75 years) with intermediate risk (Society of Thoracic Surgeons score 4%-8%) and isolated aortic stenosis were included in the study (sutureless valve = 481; transcatheter aortic valve implantation = 486). After propensity score matching, 2 matched groups of 291 patients were obtained. Transcatheter valves implanted in patients were the CoreValve (Medtronic, Minneapolis, Minn), Edwards SAPIEN-XT (Edwards Lifesciences, Irvine, Calif), and Acurate-TA (Symetis, Lausanne, Switzerland). Primary end points included all-cause death at 30 days and 5 years. Secondary end points included early and 5-year incidence of composite adverse events (major adverse cardiovascular events: all-cause death, stroke, pacemaker implant, myocardial infarction, paravalvular leak ≥II, and reoperation). RESULTS: After matching, there were no substantial differences between groups. The 30-day mortality was significantly lower in the sutureless valve group (sutureless valve = 1.7% vs transcatheter aortic valve implantation = 5.5%; P = .024) and the rate of permanent pacemaker implantation (sutureless valve = 5.5% vs transcatheter aortic valve implantation = 10.7%, P = .032). Stroke/transient ischemic attack cumulative incidence at 5 years was 1.4% in the sutureless valve group and 5.3% in the transcatheter aortic valve implantation group (P = .010). The incidence of perivalvular leak grade II or greater was 1.3% in the sutureless valve group and 9.8% in the transcatheter aortic valve implantation group (P < .001). At 60 months follow-up, the all-cause death rate was lower in the sutureless valve group than in the transcatheter aortic valve implantation group (sutureless valve = 16.1% ± 4.1% vs transcatheter aortic valve implantation = 28.9% ± 5.3%, P = .006), and the major adverse cardiovascular event rate was lower in the sutureless valve group (sutureless valve = 23.5% ± 4.1% vs transcatheter aortic valve implantation = 39.0% ± 5.6%, P = .002). Multivariable Cox regression identified transcatheter aortic valve implantation as an independent predictor for 5-year mortality and major adverse cardiovascular events (hazard ratio, 1.86; confidence interval, 1.09-3.18; P = .022) (hazard ratio, 1.73; confidence interval, 1.13-2.73; P = .010). CONCLUSIONS: Sutureless valves improved the outcomes of aortic stenosis in elderly patients with an intermediate risk profile when compared with transcatheter aortic valve implantation. The use of transcatheter aortic valve implantation in this subset population should be evaluated in further controlled randomized trials with sutureless valve use in a comparative cohort.

INTRAOCULAR LENS MALPOSITION AFTER SUTURELESS INTRASCLERAL FIXATION OF INTRAOCULAR LENS.

PURPOSE: To introduce cases of intraocular lens (IOL) malposition after sutureless intrascleral fixation. METHODS: We retrospectively analyzed the medical records of patients who underwent sutureless intrascleral fixation. Cases with postoperative IOL requiring reoperation were analyzed further. RESULTS: Of the 48 eyes that underwent sutureless intrascleral fixation of their IOL, seven eyes had postoperative IOL malposition and underwent reoperation (14.6%). There was no difference in the clinical results between the intravitreal (33 eyes) and intracameral (15 eyes) techniques, but IOL malposition requiring reoperation was more frequent in the latter (2 cases [6.1%] vs. 5 cases [33.3%], P = 0.024). In the 7 eyes that required reoperation, the visual acuity before reoperation was 0.9 ± 0.6 logMAR (20/159), whereas astigmatism was -4.8 ± 3.2 diopters. The visual acuity and cylindrical error improved to 0.1 ± 0.2 logMAR (20/25) and -2.4 ± 2.3 diopters, respectively, at 6 months after the secondary operation. CONCLUSION: In 14.6% of the patients who underwent sutureless intrascleral fixation of the IOL, IOL malposition developed and reoperation was performed. With the intravitreal technique, which uses a wider space than the intracameral technique, the frequency of postoperative IOL malposition could be reduced.

Perceval Sutureless Bioprosthesis for Degenerative Aortic Valve Stenosis: Initial Experience With 67 Patients.

OBJECTIVE: The objective of this prospective study was to evaluate the characteristics (positive and negative) of Perceval S valve in patients undergoing aortic valve replacement with a biological prosthesis. The study included 67 patients operated on at our institution and a mean follow-up period of 18 months. METHODS: From June 2016 to November 2019, 209 patients underwent aortic valve replacement with a biological prosthesis. Of these, 67 patients were included in the study based on the exclusion and inclusion criteria set before the study began. Their data were recorded during their hospital stay (preoperative, intraoperative, and early and late postoperative time). RESULTS: Fifty-four patients underwent isolated aortic valve replacement (group I) with a Perceval S prosthesis, and 13 patients had combined aortic valve replacement procedures and CABG procedures (group II). Patients were implanted with the following prosthesis sizes: S (N = 12), M (N = 18), L (N = 28), or XL (N = 9). The Perceval S valve successfully was implanted in 67 (91.8%) patients (in 6 patients, the preoperative transthoracic echocardiographic data did not coincide with intraoperative TEE and surgical measurement of the size of the annulus in the suture). Surgical approaches in patients were medial sternotomy (N = 48), mini sternotomy (N = 15), and thoracotomy through the second intercostal space to the right (N = 4). The mean clamping time of the aorta and CPB length for isolated cases was 54 and 82 minutes, respectively, and 96 and 120 minutes for combined procedures. Four (5.9%) patients died within 30 days. CONCLUSION: Early postoperative results showed that the Perceval S valve was safe. Further follow up is required to evaluate the long-term duration of patients with this bioprosthesis.

Perioperative platelet reduction after sutureless or stented valve implantation: results from the PERSIST-AVR controlled randomized trial.

OBJECTIVES: Platelet count reduction is a common but not fully understood phenomenon after aortic valve replacement (AVR) with bioprosthesis implantation. The aim of the present study was to investigate the occurrence and the clinical impact of platelet count reduction in patients receiving the Perceval bioprosthesis compared to those receiving standard sutured stented bioprosthetic aortic valve in a randomized, controlled AVR study. METHODS: PERceval Sutureless Implant versus STandard Aortic Valve Replacement is a prospective, randomized, adaptive, open-label trial. Patients were randomized (March 2016-September 2018) to AVR with a sutureless or stented valve. Ad hoc analyses have been performed to evaluate the occurrence of platelet count reduction and the clinical impact of the platelet variations in the 2 groups. RESULTS: The Perceval group showed a higher platelet reduction than the control group (46% vs 32%). The phenomenon was transient in both groups, with a slow recovery of the platelet count by hospital discharge. No differences were observed between groups regarding need of transfusions, blood loss, major bleeding and stroke events. CONCLUSIONS: The Perceval sutureless aortic bioprosthesis implantation is associated with higher rate of transient platelet reduction as compared to stented bioprostheses for AVR. However, the platelet count reduction is transient and the decline does not affect the patient's clinical outcomes. Current explanations for this phenomenon are speculative, and further investigations are required to elucidate it. CLINICAL TRIAL REGISTRATION NUMBER: NCT02673697-ClinicalTrials.gov-4 February 2016.

Suture reduction of the borderline ascending aortic dilatation during aortic valve replacement.

BACKGROUND: This study was conducted to evaluate the efficacy of simple suture reduction of the ascending aorta (SRA) performed with aortic valve replacement (AVR) in patients with borderline ascending aortic dilatation (45-50 mm). METHODS: Ninety-eight patients (ascending aortic diameter 47.7±3.4 mm) who underwent concomitant SRA with AVR were enrolled. Median follow-up duration was 83 (IQR 27-173) months. Computed tomographic angiography (CTA) follow-up was performed at 71 (47-149) months after surgery (N.=69). At least two CTA scans were performed in 34 patients (interval = 63 [46, 156] months). Early and long-term outcomes were evaluated, and dilatation rate (mm/year) of the repaired aorta was analyzed. Major adverse aortic events (MAEs) were defined as death related to aortic events, including sudden death, aortic rupture or dissection, aortic reoperation and recurrent aortic aneurysm (>45 mm). RESULTS: Early mortality rate was 2.0%. No patients had postoperative complications associated with SRA. A recurrent aortic aneurysm (>45 mm) was found in nine patients, but none of the patients had an ascending aorta diameter >50 mm. A multivariable analysis demonstrated that neither preoperative diameter of the ascending aorta nor bicuspid valve was associated with dilatation of the repaired aorta. Co-existing coronary artery disease was associated with both recurrent aneurysm and increased dilatation rate after SRA. There were two cases of sudden death and no one suffered from aortic dissection, rupture or aortic reoperation. Ten- and 20-year freedom rates from MAE were 90.3% and 79.3%, respectively. CONCLUSIONS: Concomitant SRA might be a safe and effective surgical alternative to ascending aorta replacement in AVR patients with borderline ascending aortic dilatation regardless of aortic valve pathology.

Perceval S valve empire: healing the Achilles' heel of sutureless aortic valves.

Aortic valve replacement is the treatment of choice concerning aortic valve disease. Excellent short- and long-term clinical results are reported. Patients referred for aortic valve replacement are getting older and older, so bioprosthetic valves play a more central role worldwide. However, patient comorbidities are also increased more often rendering patients unsuitable for open conventional aortic valve replacement. As a result, transcatheter aortic valve implantation has become the treatment of choice in patients at very high surgical risk. However, the percutaneous technique is related to major disadvantages provided that the diseased native valve is left in place. Its durability is also uncertain. More recently, sutureless Perceval S valve bioprosthesis has gained ground in the field of aortic stenosis therapy filling the gap between conventional aortic valve replacement and transcatheter approach. Excellent hemodynamic and clinical results are reported. Its deployment is performed under direct view and ischemic and overall operative times are significantly decreased. Five-year follow-up results are also optimal. However, the "Achilles' heel" of sutureless technology is increased rates of postoperative permanent pacemaker implantation requirement compared to conventional approach. The incidence of this complication varies in literature. Patient-related factors such as preoperative conduction disorders, older age and short membranous septum are predictors of postoperative pacemaker requirement. However, several technical modifications regarding manufacturer recommendations can be adopted to mitigate this complication. Appropriate annular decalcification, higher guiding sutures placement, reduced balloon pressure and duration and avoiding of oversizing can contribute to prevent from this complication.

A Modified Approach with Caval Transection for Supracardiac Total Anomalous Pulmonary Venous Connection: Comparison Between Conventional and Sutureless Surgery in 173 Patients.

The efficacy of primary sutureless repair for supracardiac total anomalous pulmonary venous connection (TAPVC) needs to be confirmed. This study aimed to compare the long-term outcomes between the conventional surgery and the sutureless technique with a modified approach in superior TAPVC. Between January 2008 and December 2018, 173 patients with supracardiac TAPVC underwent surgery either with the conventional procedure (n = 130) or the sutureless repair (n = 43). Multivariate analysis and competing-risk analysis were used to identify risk factors for early death and postoperative pulmonary venous obstruction (PVO), respectively. Among 173 patients who underwent repair of supracardiac TAPVC, 46 (28%) had preoperative PVO, and 22 (12.7%) had postoperative PVO. The sutureless group had a lower postoperative PVO rate compared with the conventional group (p = 0.027). The risk factors for death were age ≤ 28 days [odds ratio (OR), 11.56; 95% confidence interval (CI) 1.33-100.47, p = 0.015], weight ≤ 3 kg (OR 9.57; 95% CI 1.58-58.09, p = 0.009), emergency operation (OR 19.24; 95% CI 3.18-116.35, p = 0.002), cardiopulmonary bypass time (OR 2.16; 95% CI 1.36-3.43, p = 0.003), cross-clamp time (OR 1.73; 95% CI 1.20-2.50, p = 0.022), and duration of ventilation (OR 1.11; 95% CI 1.02-1.21, p = 0.027). Age ≤ 28 days [Hazard Ratio (HR) 1.92; 95% CI 1.92-11.02, p < 0.001] and preoperative PVO (HR 41.70; 95% CI 8.15-213.5, p < 0.001) were associated with postoperative PVO. The sutureless repair is a reliable technique for supracardiac TAPVC. Age ≤ 28 days is associated with 30-day mortality and postoperative PVO.

[Outcomes of various techniques of mesh prosthesis fixation in laparoscopic hernia repair]. / Rezul'taty razlichnykh metodik fiksatsii setchatogo proteza pri laparoskopicheskoi gernioplastiki (TAPP).

OBJECTIVE: To compare early and long-term results of various mesh prosthesis fixation methods in laparoscopic inguinal hernia repair. MATERIAL AND METHODS: It is a prospective clinical non-randomized trial. The study included 212 patients. Conventional stapler fixation (112 patients), self-gripping mesh implants (48 patients) and n-butyl cyanoacrylate adhesive fixation (52 patients) were compared. We estimated surgery time, pain syndrome severity in early and long-term postoperative period, postoperative morbidity and recurrence rate were evaluated. RESULTS: Early postoperative morbidity, activation of patients and hospital-stay were similar in all groups. Pain syndrome within 6 postoperative hours in the first group exceeded the same parameter in the second group by 1.23 times (95% CI 1.15-1.31, p<0.05) and by 1.19 times in the third group (95% CI 1.12-1.26, p<0.05). Within 12 hours, pain syndrome in the first group was 1.27 times more severe compared to the third group (95% CI 1.20-1.34, p<0.05). Pain syndrome in long-term period was similar in all groups. In the first group, one recurrence was detected (0.9%). CONCLUSION: There were no significant between-group differences. However, we found the correlation of postoperative pain syndrome with mesh implant fixation technique.

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

OBJECTIVE: Sutureless 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. METHODS: The 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. RESULTS: At 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. CONCLUSIONS: Sutureless 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.

Hypo-attenuated leaflet thickening and reduced leaflet motion after the implantation of the Perceval S sutureless bioprosthesis.

Hypo-attenuated leaflet thickening (HALT) is gaining attention as a relatively common issue after surgical or transcatheter aortic valve replacement (AVR). However, only a few reports have described HALT in sutureless bioprosthesis, which has emerged as a promising tool with excellent hemodynamics and enhanced implantability. We herein report a 75-year-old woman who underwent quintuple coronary artery bypass grafting and sutureless AVR with a Perceval S bioprosthesis (LivaNova PLC, London, UK). Despite an uneventful perioperative course, her recovery was slow with persistent pleural effusion. Echocardiography revealed an increased transvalvular pressure gradient, and HALT was confirmed by computed tomography. The patient received aggressive anticoagulation therapy with resolution of the HALT and made an uneventful recovery. Current guidelines provide no specific recommendations for peri-procedural antithrombotic therapy for sutureless AVR. However, HALT is not rare after sutureless AVR and can lead to significant clinical consequences. In this case, aggressive anticoagulation therapy with systemic heparinization was effective as HALT treatment following early post-sutureless AVR. Further investigation is required to determine the optimal antithrombotic strategy for sutureless AVR.

Results in comparison between 30 gauge ultrathin wall and 27 gauge needle in sutureless intraocular lens flanged technique in diabetic patients: 24-month follow-up study.

AIMS: Intraoperative complications in cataract surgery are more common in diabetic patients. Solving aphakia in these circumstances remains a challenge, as the scleral structure has been shown to be different in diabetes. This study aims to analyze the role of a secondary sutureless scleral intraocular lens (IOL) flanged fixation in diabetic patients without capsular support and to compare the anatomical and functional outcomes using a 30 gauge (G) ultrathin wall needle vs. a 27G needle. METHODS: Retrospective, observational cohort study. 105 eyes (105 patients) who underwent PPV with secondary IOL fixation using a sutureless 27G (n = 51) or a 30G ultrathin wall (UTW) needle technique (n = 54) and had a 24 months postoperative follow up. Consecutive patients' records were reviewed for lens stability and centration parameters, intra- and postoperative complications at 7 days, 1, 3, 6, 12, and 24 months after surgery. Correlations between outcome measures and needle size (27G vs. 30G UTW) were analyzed. RESULTS: IOL displacement occurred in 30 patients (41.2%) in the 27G group and did not occur in the 30G UTW needle group (p < 0.001). Mean time until IOL displacement was 10.5 ± 7.0 months (range: 7 days-24 months). IOL centricity was significantly better in the 30G ultrathin wall needle group compared to 27 G (p = 0.001). Additional surgical interventions were necessary only in the 27G group (n = 14). CONCLUSIONS: Sutureless IOL flanged technique using a 30G UTW needle is more predictable and has less complications in aphakic diabetic patients, compared to a 27G needle technique.

Leaflet thickening and stent geometry in sutureless bioprosthetic aortic valves.

Underexpansion of transcatheter heart valves and the surgically implanted Perceval sutureless aortic valve bioprosthesis has been suggested as an underlying mechanism for hypo-attenuated leaflet thickening (HALT). This was a single-center prospective observational study that included 47 patients who underwent surgical aortic valve replacement with the Perceval sutureless bioprosthesis (LivaNova, London, United Kingdom) from 2012 to 2016 and were studied by four-dimensional cardiac computed tomography (CT). The association between overall and regional expansion and the prevalence of HALT was analyzed. In total 46 patients were included in the analysis. HALT was found in 39.1% of patients and the mean overall prosthesis expansion was 75.5 ± 5.2% (range 64.6-84.8%). Overall expansion did not differ between patients with HALT compared with patients without HALT (mean overall expansion 74.0 ± 5.2% vs. 76.5 ± 5.0%, P = 0.11). The prevalence of HALT was lower in patients with overall expansion > 80% compared to patients with expansion < 80% expansion though not significantly (20% vs. 44.4%, P = 0.16). None or trivial regional underexpansion was found in 94.7% of coronary cusps. There was no significant association between regional underexpansion and the prevalence of HALT (mean coronary cusp angle 120 ± 8° vs. 119 ± 10°, P = 0.53). The prevalence of HALT and overall underexpansion was high in the Perceval sutureless bioprosthetic valve. Overall underexpansion was not associated with HALT. Whether severe overall underexpansion increases the risk for HALT requires further study. Regional underexpansion was uncommon in the Perceval sutureless bioprosthetic valve and not associated with HALT.Clinical trial registration Unique identifier: NCT03753126 (http://www.clinicaltrials.gov).

Minimally Invasive Endoscopic Aortic Valve Replacement: Operative Results.

To describe our endoscopic aortic valve replacement (E-AVR) technique and to evaluate its early results regardless of the type of prosthetic valve implanted and the patients' characteristics. From July 2013 to September 2018, 125 patients (76 males, mean age 68.8 ± 10.9 years, mean EuroScore II 1.51 ± 1.39) underwent isolated E-AVR due to a severe stenosis in 99 cases and insufficiency in 26 cases. The surgical access was a 3-4 cm working port in the second right intercostal space with no rib-spreading and 3 additional 5 mm miniports for the introduction of a 30-degree thoracoscope, the Chitwood clamp, and the vent line. Cardiopulmonary bypass (CPB) was achieved through a femoro-femoral cannulation. All patients successfully underwent E-AVR. Stended bioprostheses were implanted in 56 cases, Rapid Deployment and Sutureless valves in 23 and 46 cases, respectively. Mean cross-clamping and CPB times were 87.5 ± 22.1 and 126.1 ± 28.4 minutes, respectively, and a significant difference between the types of prostheses was observed: 69.1 ± 15.1 and 106.2 ± 21.8 minutes (Sutureless) vs 93.2 ± 15.1 and 135.5 ± 21.8 minutes (Rapid Deployment) vs 100.6 ± 17.2 and 138.9 ± 21.9 minutes (Stented). Mean ventilation and ICU times and hospital stay were 10.9 ± 39.3 hours, 45.9 ± 58.4 hours, and 8.3 ± 9.3 days, respectively. Thirty-day mortality was 0.8%. One patient (0.8%) needed a re-exploration for bleeding and 3 patients (2.4%) required a new permanent pacemaker implantation. No major neurologic events were observed. No paravalvular leakage was detected at discharge. E-AVR is associated with low mortality and few complications. Sutureless bioprostheses significantly reduce cross-clamping and CPB times. In dedicated centers, this approach may become a valid alternative to other minimally invasive techniques.

Hemodynamic Comparison of Sutureless and Rapid-Deployment Valves with Conventional Bioprostheses.

BACKGROUND: Sutureless and rapid-deployment bioprostheses (RPDs) are advantageous due to shorter aortic cross-clamp times (ACCs); however, few studies have investigated hemodynamic outcomes in comparison to conventional bioprostheses (CBs). METHODS: All patients receiving the Perceval (LivaNova, London, United Kingdom) and Intuity (Edwards Lifesciences, Irvine, California, United States) valves from February 2016 to December 2017 were included (n = 61). For controls, patients who underwent aortic valve replacement using CB from 2015 to 2018 (n = 743) were propensity-matched (n = 108). Primary end points were mean gradient at discharge, true internal diameter (ID) after implantation, and paravalvular leakage. Secondary end points were ACCs, cardiopulmonary bypass times (CPBTs), mortality, and pacemaker implantation. RESULTS: Age was 73.2 years (standard deviation [SD]: 7.6) in the RPD group and 72.9 years (SD: 7.3) in the CB group (p = 0.827). Median logistic EuroSCORE II was 3.4% (Q1: 2; IQ3: 5.3) and 3% (Q1: 1.9; IQ3: 5.6; p = 0.599). While ACCs and CPBT were shorter in RPDs (97 [SD: 31.4] vs. 125.4 minutes [SD: 62.1], p = 0.003; and 76.1 [SD: 25.7] vs. 89.7 minutes [SD: 34.3], p = 0.022), procedural times were similar (p = 0.257). True ID was 21.97 mm (SD: 1.79) in RPDs and 20.15 mm (SD: 1.70) in CB (p < 0.001).RPDs and CB resulted in comparable mean gradients (12.8 mm Hg [SD: 6.4] vs. 13.8 mm Hg [SD: 5.6]; p = 0.387) and rate of paravalvular regurgitation. There were no differences in the rates of pacemaker implantation and mortality.In a subanalysis of RPDs, mean gradient was 15.48 mm Hg (SD: 7.51) in Perceval (n = 21) and 10.79 mm Hg (SD: 4.78) in Intuity (n = 33; p = 0.010). CONCLUSIONS: RPDs provided comparable hemodynamic performance, although implanted valves were larger in true ID. Whether this provides superior hemodynamic performance during exercise and longer durability needs further investigation. Among RPDs, the Intuity valve provided lower mean gradients at rest than Perceval valve.

Outcome of a Modified Perceval Implantation Technique.

BACKGROUND: In our institution, we developed a modification of the standard implantation technique of the Perceval sutureless aortic prosthesis (LivaNova, London, United Kingdom) that involves the usage of snuggers for the guiding sutures during valve deployment. The technique has been described elsewhere. In this article, we present the results of our initial case series comprising 128 consecutive patients. METHODS: From September 2016 to June 2018, 128 patients received a sutureless Perceval prosthesis (mean age 72.2 ± 8.5 years, 66 males). The data of the patients were prospectively collected in our general database and retrospectively analyzed using the SPSS software version 25 (IBM SPSS Inc., Chicago, Illinois, United States). Primary end points were primary implantation success and 30-day mortality. All patients underwent transthoracic echocardiography on discharge. RESULTS: Our cohort consisted of real-world scenario patients with infective endocarditis, bicuspid aortic valves and one patient with left ventricular assist device. However, we had 100% primary implantation success with no need for valve explantation or paravalvular leaks. All-cause 30-day mortality was 2.3% (3 patients) with no cardiac deaths. Two patients (1.6%) had a permanent neurological deficit, three patients (2.3%) had new-onset renal dialysis, and four patients (3.1%) needed a permanent pacemaker postoperatively. CONCLUSION: To our knowledge, this is the first case series to report on a modified implantation technique of the Perceval prosthesis. The Perceval valve prosthesis produces excellent outcome in most pathologies, so that current contraindications should be revised.

Sutureless versus Stented Bioprostheses for Aortic Valve Replacement: The Randomized PERSIST-AVR Study Design.

INTRODUCTION: Sutureless biological valves for surgical aortic valve replacement (SAVR), characterized by the absence of anchoring sutures at the aortic annulus, are gaining popularity because of ease and reproducibility of implant, shorter operating times, and enhancement of minimally invasive approaches. The stentless configuration of the sutureless valve was designed to achieve optimal hemodynamic performance. MATERIALS AND METHODS: PERSIST-AVR (PERceval Sutureless Implant versus STandard Aortic Valve Replacement) is a prospective, randomized, adaptive, open-label, international, postmarket trial (NCT02673697). The primary objective of the trial is to assess the safety and efficacy of the Perceval (LivaNova, London, UK) sutureless bioprosthesis among patients undergoing SAVR in the presence of severe aortic stenosis to demonstrate the noninferiority of Perceval as compared with standard sutured stented bioprosthetic aortic valve as an isolated procedure or combined with coronary artery bypass grafting. Sample size will be determined adaptively through interim analyses performed by an Independent Statistical Unit till a maximum of 1,234 patients, enrolled at ∼60 sites in countries where the device is commercially available. Patients will be followed up for 5 years after implant. The primary end point is the number of patients free from major adverse cardiac and cerebrovascular-related events at 1 year. Additional secondary outcomes will be assessed up to 5 years. DISCUSSION: PERSIST-AVR is the first prospective, randomized study comparing in-hospital and postdischarge outcomes in a robust population of patients undergoing SAVR with either the Perceval sutureless bioprosthesis or a conventional sutured stented bioprosthesis up to 5 years.