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Background: The aim of this study is to report the preliminary real-word clinical and hemodynamic performance from the MANTRA study in patients undergoing aortic valve replacement with Perceval PLUS sutureless valve., Methods: MANTRA is an ongoing "umbrella" prospective, multi-center, international post-market study to collect real-life safety and performance data on Corcym devices (Corcym S.r.l, Saluggia, Italy). Clinical and echocardiographic outcomes were collected preoperatively, at discharge and at each follow up. KCCQ-12 and EQ-5D-5L quality of life questionnaires were collected preoperatively and at 30-days., Results: A total of 328 patients underwent aortic valve replacement with Perceval PLUS in 29 International institutions. Patients were enrolled from July 2021 to October 2023 and enrollment is still ongoing. Mean age was 71.9 ± 6.4 years, mean EuroSCORE II was 2.9 ± 3.9. Minimally invasive approach was performed in 44.2% (145/328) of patients; concomitant procedures were done in 40.8% (134/328) of cases. Thirty-day mortality was 1.8% (6/328) and no re-interventions were reported. Pacemaker implant was required in 4.0% (13/328) of the patients. The assessment of the functional status demonstrated marked and stable improvement in NYHA class in most patients at 30-day follow-up, with significant increase of KCCQ-12 summary score (from 58.8 ± 23.0 to 71.8 ± 22.1, p < 0.0001) and EQ-5D-5L VAS score (from 64.5 ± 20.4 to 72.6 ± 17.5, p < 0.0001). Mean pressure gradient decreased from 46.2 ± 17.3 mmHg to 10.1 ± 4.7 mmHg at 30-day follow-up. Low or no incidence of moderate-to-severe paravalvular or central leak was reported., Conclusions: Preliminary results demonstrate good clinical outcomes and significant improvement of Quality of Life at 30-days, excellent early hemodynamic performance within patient implanted with Perceval PLUS., Trial Registration: The MANTRA study has been registered in ClinicalTrials.gov (NCT05002543, Initial release 26 July 2021)., (© 2024. The Author(s).)

Background: Aortic valve calcification is supposed to be a possible cause of embolic stroke or subclinical valve thrombosis after transcatheter aortic valve replacement (TAVR). We aimed to assess the role of aortic valve calcification in the occurrence of in-hospital clinical complications and survival after TAVR., Methods: We retrospectively analyzed preoperative contrast-enhanced multidetector computed tomography scans of patients who underwent TAVR on the native aortic valve in our center. Calcium volume was calculated for each aortic cusp, above and below the aortic annulus. Outcomes were recorded according to VARC-2 criteria., Results: Overall, 581 patients were included in the study (SapienXT = 192; Sapien3 = 228; CoreValve/EvolutR = 45; Engager = 5; Acurate = 111). Median survival was 4.98 years (interquartile range 4.41-5.54). Logistic regression identified calcium load beneath the right coronary cusp in left ventricular outflow tract (LVOT) as significantly associated with stroke (odds ratio [OR] 1.2; 95% confidence interval [CI] 1.03-1.3; p = 0.0019) and in-hospital mortality (OR 1.1; 95% CI 1.004-1.2; p = 0.04), whereas total calcium volume of the LVOT was associated with both in-hospital and 30 day-mortality (OR 1.2; 95% CI 1.01-1.4; p = 0.03, and OR 1.2; 95% CI 1.02-1.43; p = 0.029, respectively). Cox regression identified total calcium of LVOT (hazard ratio [HR] 1.18; 95% CI 1.02-1.38; p = 0.026), male sex (HR 1.88; 95% CI 1.06-3.32; p = 0.031), baseline creatinine clearance (HR 0.96; 95% CI 0.93-0.98; p < 0.001), and baseline severe aortic regurgitation (HR 7.48; 95% CI 2.76-20.26; p < 0.001) as risk factors associated with lower survival., Conclusion: LVOT calcification is associated with increased risk of peri-procedural stroke and mortality as well as shorter long-term survival., Competing Interests: Declaration of competing interest TF is consultant for LivaNova. SP is proctor for LivaNova. The other authors have no conflicts of interest to disclose. No funding was provided for this study., (Copyright © 2020 Society of Cardiovascular Computed Tomography. Published by Elsevier Inc. All rights reserved.)

Backgropund and Aim: Postoperative thrombocytopenia after surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR) and aggravating causes were the aim of this retrospective study., Methods: Data of all patients treated with SAVR (n = 1068) and TAVR (n = 816) due to severe aortic valve stenosis was collected at our center from 2010 to 2017. Preprocedural and postprocedural values were collected from electronic patient records., Results: There was a significant drop in platelets in both groups, the TAVR group showed overall superior platelet preservation compared to the AVR group (P < .001). In the SAVR subgroup analysis, a significant difference in platelet preservation was observed between the valve types (P < .001), particularly with the Freedom SOLO valve. In the TAVR subgroup analysis, the valve type did not influence platelet count (PLT) reduction (P = .13). In the SAVR subgroup analyses, PLT was found to be worsened with cardiopulmonary bypass (CPB) duration., Conclusion: Thrombocytopenia frequently occurs after implantation of a biological heart valve prosthesis, with a higher frequency observed in patients after cardiac surgery rather than TAVR. Although some surgical bioprosthetic models are more susceptible to this phenomenon, CPB duration seems to be a major determinant for the development of postoperative thrombocytopenia., (© 2020 Wiley Periodicals, Inc.)

Background: Several studies reported high rates of postoperative permanent pacemaker (PPM) implantation, which has been described as the "Achilles' heel" of sutureless aortic valve replacement (AVR)., Methods: From July 2010 to December 2017, 3,158 patients with symptomatic, severe aortic valve stenosis were referred to the Department of Cardiac Surgery (Klinikum Nürnberg - Paraclesus Medical University, Nuremberg, Germany), and 512 received a Perceval sutureless bioprosthesis (LivaNova PLC, London, United Kingdom). Thirty-nine patients who had been discharged with concomitant PPM implantation were reevaluated., Results: After a cumulative follow-up of 1,534 months (100% complete, median 50 months, interquartile range 30 months, maximum 76 months, minimum 3 months), a total of 22 patients were still pacemaker dependent. Kaplan-Meier analysis showed pacemaker-dependent rhythm in 92.0%, 80.0%, 49.4%, and 32.3% of patients at 1, 2, 4, and 5 years, respectively. At Cox regression analysis, pressure during valve deployment (hazard ratio, 79.41; p = 0.0003) and "late-onset" atrioventricular block were found to be independent predictors of sinus rhythm restoration (hazard ratio, 0.16; p = 0.0061). Log-rank test showed significantly lower pacemaker dependency rates in patients with "low-pressure" prosthesis implantation (p < 0.0001)., Conclusions: This study shows that several technical measures, including appropriate annulus decalcification, precise positioning of guiding sutures, release of traction sutures applied to the valve commissures, and ballooning with reduced pressure, all reduce the rate of PPM implantation after sutureless AVR. Furthermore, a high proportion of patients were found to be no longer pacemaker dependent at follow-up., (Copyright © 2019 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Aims: To assess the contribution of aortic valve calcification to the occurrence of transient or permanent atrioventricular block (AVB) and the need for permanent pacemaker implantation (PPI) after transcatheter aortic valve implantation (TAVI) in a large single-centre cohort., Methods and Results: We retrospectively analysed pre-operative contrast-enhanced multidetector computed tomography scans of patients who underwent TAVI in our centre between 2012 and 2016. Calcium volume was calculated for each aortic cusp above (aortic valve), and below [left ventricular outflow tract (LVOT)] the basal plane. Clinical and procedural data as well as pre-operative electrocardiograms were evaluated. Multivariate analysis was performed to evaluate risk factors for transient and permanent AVB. A total of 342 patients receiving a balloon-expandable prosthesis were included in the study. Overall incidence of transient and permanent AVB was 4% (n = 14) and 7.6% (n = 26), respectively. On logistic regression analysis, baseline right bundle branch block [odds ratio (OR) 7.36, 95% confidence interval (CI) 2.6-20.6; P < 0.01], degree of oversizing (OR 1.04, 95% CI 1.01-1.07 P = 0.02), prior percutaneous coronary intervention (OR 2.8, 95% CI 1.1-7.3), and LVOT calcification beneath the non-coronary cusp (OR for an increase of 10 mm3 = 1.06, 95% CI 1-1.1; P = 0.03) were found to be independently associated with permanent AVB and PPI, whereas calcification of LVOT beneath the right coronary cusp (OR for an increase of 10 mm3 = 1.16, 95% CI 1.02-1.3; P = 0.02) and balloon post-dilation (OR 3.8, 95% CI 1.2-11.8; P = 0.02) were associated with reversible AVB., Conclusion: Left ventricular outflow tract calcifications are associated with transient and non-reversible AVB after TAVI, and its evaluation could help in predicting onset and reversibility of AVB., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2019. For permissions, please email: journals.permissions@oup.com.)

Objective: To assess risk factors for paravalvular leak (PVL) after transcatheter aortic valve implantation in a large single-center cohort, including measurement of aortic valve calcification using a reproducible method., Methods: We retrospectively analyzed preoperative contrast-enhanced multidetector computed tomography scans of patients who underwent transcatheter aortic valve implantation in our center between 2009 and 2016. Calcium volume was calculated for each aortic cusp in the aortic valve, left ventricular outflow tract, and device landing zone., Results: Overall, 539 patients were included in the study who had experience with 4 prothesis types (SapienXT [Edwards Lifesciences, Irvine, Calif] [n = 192], Sapien3 [Edwards Lifesciences] [n = 206], CoreValve EvolutR [Medtronic, Minneapolis, Minn] [n = 44], and Acurate [Symetis, Ecublens, Switzerland] [n = 97]). Median calcium volume in the device landing zone was 757 mm 3 , with no significant differences among the 4 prosthesis groups. None of the patients had severe PVL. The overall incidence of mild-to-moderate PVL was 15.8% (95% confidence interval [CI], 12.8%-19.1%). On multivariate logistic regression, device landing zone calcification (P = .00006; odds ratio for an increase of 100 mm 3 , 1.08; 95% CI, 1.04-1.13) and use of the CoreValve (P = .0028; odds ratio, 4.1; 95% CI, 1.6-10 with SapienXT as reference) prosthesis were found to be associated with mild or greater PVL. In contrast, degree of oversizing (P = .002; odds ratio, 0.97; 95% CI, 0.95-0.99), and use of Sapien3 (P = .00005; odds ratio, 0.23; 95% CI, 0.11-0.47 with SapienXT as reference) were associated with a lower incidence of mild or greater PVL., Conclusions: Aortic calcification volume in the device landing zone is associated with residual PVL after transcatheter aortic valve implantation. When taking calcification into account, the balloon-expandable prosthesis Sapien3 seems to be associated with a lower incidence of PVL., (Copyright © 2018 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

The aim of this study was to compare the immediate outcome of patients undergoing transcatheter (TAVI) versus surgical aortic valve replacement with the sutureless Perceval bioprosthesis (SU-AVR). This is a retrospective multicenter analysis of 773 patients who underwent either TAVI (394 patients, mean age, 80.8 ± 5.5 years, mean EuroSCORE II 5.6 ± 4.9 %) or SU-AVR (379 patients, 77.4 ± 5.4 years, mean EuroSCORE II 4.0 ± 3.9 %) with or without concomitant myocardial revascularization. Data on SU-AVRs were provided by six European institutions (Belgium, Finland, Germany, Italy and Sweden) and data on TAVIs were provided by a single institution (Catania, Italy). In-hospital mortality was 2.6 % after SU-AVR and 5.3 % after TAVI (p = 0.057). TAVI was associated with a significantly high rate of mild (44.0 vs. 2.1 %) and moderate-severe paravalvular regurgitation (14.1 vs. 0.3 %, p < 0.0001) as well as the need for permanent pacemaker implantation (17.3 vs. 9.8 %, p = 0.003) compared with SU-AVR. The analysis of patients within the 25th and 75th percentiles interval of EuroSCORE II, i.e., 2.1-5.8 %, confirmed the findings of the overall series. One-to-one propensity score-matched analysis resulted in 144 pairs with similar baseline characteristics and operative risk. Among these matched pairs, in-hospital mortality (6.9 vs. 1.4 %, p = 0.035) was significantly higher after TAVI. SU-AVR with the Perceval prosthesis in intermediate-risk patients is associated with excellent immediate survival and is a valid alternative to TAVI in these patients.

Objectives: The aim of this study was to analyse early postoperative outcomes and 2-year survival after aortic valve replacement (AVR) through a ministernotomy with a sutureless bioprosthesis implantation compared with a full sternotomy with implantation of a stented bioprosthesis., Methods: Patients who underwent primary isolated non-emergent AVR at six European centres were included in the study. Of these, 182 (32%) underwent a ministernotomy with a sutureless bioprosthesis (ministernotomy sutureless group) and 383 (68%) a full sternotomy with a stented bioprosthesis (full sternotomy stented group). Propensity score matching was used to reduce selection bias., Results: In the overall cohort, 30-day mortality was 1.6 and 2.1%, and 2-year survival was 92 and 92% in the ministernotomy sutureless group and in the full sternotomy stented group, respectively. Propensity score matching resulted in 171 pairs with similar characteristics and operative risk. Aortic cross-clamp (40 vs 65 min, P < 0.001) and cardiopulmonary bypass time (69 vs 87 min, P < 0.001) were shorter in the ministernotomy sutureless group. Patients undergoing ministernotomy received less packed red blood cells but the risk for postoperative permanent pacemaker implantation was higher. There were no differences regarding 30-day mortality or 2-year survival between the two groups., Conclusions: AVR through a ministernotomy with implantation of a sutureless bioprosthesis was associated with shorter aortic cross-clamp and cardiopulmonary bypass time and less transfusion of packed red blood cells, but a higher risk for postoperative permanent pacemaker implantation compared with a full sternotomy with a stented bioprosthesis., (© The Author 2015. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Background: The aim of this study was to analyze early postoperative outcomes and 2-year survival after aortic valve replacement (AVR) with the sutureless Perceval bioprosthesis (Sorin Biomedica Cardio Srl, Salluggia, Italy) performed through ministernotomy compared with full sternotomy., Methods: This was a study of 267 consecutive patients who underwent isolated AVR with the sutureless Perceval bioprosthesis between 2007 and 2014 at 6 European centers. Of these, 189 (70.8%) were performed through ministernotomy and 78 through a full sternotomy. Propensity score matching was used to reduce selection bias., Results: In the overall cohort of ministernotomy and full sternotomy patients, in-hospital mortality was 1.1% and 2.6% and 2-year survival was 92% and 91%, respectively. Propensity score matching resulted in 56 pairs with similar characteristics and operative risk. Aortic cross-clamp (44 minutes in both groups, p = 0.931) and cardiopulmonary bypass time (69 vs 74 minutes, p = 0.363) did not differ between the groups. Apart from higher values in the ministernotomy group for postoperative peak gradients (28.1 vs 23.3 mm Hg, p = 0.026) and mean aortic valve gradients (15.2 vs 11.7 mm Hg, p = 0.011), early postoperative outcomes did not differ in the propensity-matched cohort. There were no differences in the in-hospital mortality rate or 2-year survival between the groups., Conclusions: AVR with the sutureless Perceval bioprosthesis through a ministernotomy was a safe and reproducible procedure that was not associated with prolonged aortic cross-clamp or cardiopulmonary bypass time compared with a full sternotomy. Early postoperative outcomes and 2-year survival were comparable between patients undergoing ministernotomy and full sternotomy., (Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Objective: The aim of this study was to evaluate the outcome of aortic valve replacement with the sutureless Perceval S aortic valve bioprosthesis (Sorin Biomedica Cardio Srl, Saluggia, Italy)., Methods: This is a retrospective analysis of 314 patients (mean age, 77.9 ± 5.0 years, mean European System for Cardiac Operative Risk Evaluation II, 9.0% ± 7.6%) who underwent aortic valve replacement with the Perceval S valve with (94 patients) or without (220 patients) concomitant coronary artery bypass surgery at 5 European centers., Results: The Perceval S valve was successfully implanted in all but 1 patient (99.7%). The mean aortic crossclamping time was 43 ± 20 minutes (isolated procedure, 39 ± 15 minutes; concomitant coronary surgery, 52 ± 26 minutes). Severe paravalvular leak occurred in 2 patients (0.6%). In-hospital mortality was 3.2% (1.4% after isolated procedure and 7.4% after concomitant coronary surgery). In-hospital mortality was 2.8% and 4.0% among patients with a European System for Cardiac Operative Risk Evaluation II less than 10% and 10% or greater, respectively (P = .558). Octogenarians had slightly higher in-hospital mortality (5.2% vs 2.0%, P = .125; after isolated procedure: 2.7% vs 0.7%, P = .223; after concomitant coronary surgery: 9.5% vs 5.8%, P = .491) compared with younger patients. Full sternotomy did not increase the in-hospital mortality risk compared with ministernotomy or minithoracotomy access (1.3% vs 1.4%, when adjusted for baseline covariates: P = .921; odds ratio, 0.886; 95% confidence interval, 0.064-12.346). One-year survival was 90.5%. Freedom from valve-related mortality, stroke, endocarditis, and reoperation was 99.0%, 98.1%, 99.2%, and 98.3%, respectively., Conclusions: The sutureless Perceval S valve is associated with excellent early survival in high-risk patients, particularly among those undergoing an isolated procedure. Further studies are needed to prove the durability of this bioprosthesis., (Copyright © 2014 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.)

Background: Sutureless aortic valve prostheses have the potential of shortening ischemic time. However, whether shorter operative times may also result in improved patient outcomes and have an effect on hospital costs remains to be established., Methods: From March 2010 to April 2013, 566 patients underwent aortic valve replacement with bioprostheses; of these, 166 received a sutureless valve, and 400 received a stented valve. Redo and associated procedures were included. A propensity-score analysis was used to create two groups (sutureless and stented) with 82 matched pairs with comparable preoperative characteristics. Hospital outcome, follow-up, and health care resource consumption were compared., Results: There were 3 hospital deaths in the stented group and 2 in the sutureless group (p=0.65). Aortic cross-clamp, cardiopulmonary bypass, and operation times were significantly shorter in the sutureless group (p<0.001). Patients in the sutureless group required blood transfusion less frequently (1.2±1.3 vs 2.5±3.7 units, p=0.005), with a similar need for reexploration for bleeding (2 vs 5, p=0.221). The sutureless group had a shorter intensive care unit stay (2.0±1.2 vs 2.8±1.3 days, p<0.001), hospital stay (10.9±2.7 vs 12.4±4.4 days, p=0.001) and intubation time (9.5±4.6 vs 16.6±6.4 hours, p<0.001), and a lower incidence of postoperative atrial fibrillation (p=0.015), pleura effusions (p=0.024), and respiratory insufficiency (p=0.016). Pacemaker implantation and occurrence of neurologic events were similar between groups (p>0.05). A lower rate of postoperative complications resulted in reduced resource consumption in the sutureless group for diagnostics (€2,153 vs €1,387), operating room (€5,879 vs €5,527), and hospital stay (€9,873 vs €6,584), with a total cost saving of approximately 25% (€17,905 vs €13,498)., Conclusions: A shorter procedural time in the sutureless group is associated with better clinical outcomes and reduced hospital costs., (Copyright © 2014 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Objectives: Left ventricular (LV) hypertrophy in aortic stenosis (AS) is considered a compensatory response helping maintain systolic function, but constitutes a risk factor for cardiac morbidity and mortality. The aim of this study was to assess the degree of LV mass regression after sutureless implantation of the Perceval S aortic valve bioprosthesis (Sorin Group, Saluggia, Italy)., Methods: Between March 2010 and July 2012, 78 patients with symptomatic AS underwent isolated aortic valve replacement (AVR) with the Perceval bioprosthesis. Mean age was 77.1 ± 5.3 years, 46 patients were female (59%) and mean logistic EuroSCORE was 11 ± 7.5%. Echocardiography was performed preoperatively, at discharge, and at follow-up (mean 13.5 ± 7.3 months). LV mass was calculated using the Devereux formula and indexed to body surface area., Results: There was 1 in-hospital non-cardiac death and 3 late deaths. LV mass index decreased from 148.4 ± 46 g/m(2) at baseline to 119.7 ± 38.5 g/m(2) at follow-up (P = 0.002). No significant changes were observed in LV hypertrophy and/or relative wall thickness >0.42 as well as in LV ejection fraction. Mean aortic gradient decreased from 49.5 ± 15.8 mmHg at baseline to 11.6 ± 5.1 mmHg at discharge and 8.3 ± 4.4 mmHg at follow-up (P < 0.001), resulting in significant clinical improvement. No moderate or severe paravalvular leakage was observed at discharge and at follow-up., Conclusions: In AS patients, isolated AVR with the Perceval sutureless bioprosthesis is associated with significant LV mass regression at 1-year follow-up. However, longer-term follow-up is necessary to confirm these findings.

Background: An unexplained condition that follows transcatheter aortic valve implantation (TAVI) is platelet count reduction (PR). According to published research, patients with balloon-expandable valves (BEVs) had a greater PR than those with self-expandable valves (SEVs). Objectives: The purpose of this study was to investigate the incidence and clinical effects of PR following TAVI. Methods: In total, 1.122 adult TAVI patients were enrolled. Propensity score matching was carried out in a 1:1 ratio between patients with BEVs and those with SEVs. The analysis included changes in platelet count, in-hospital mortality, and early postoperative adverse events. Results: Notably, 632 patients were matched (BEV:316; SEV:316). All patients' post-procedural platelet counts changed according to a parabolic curve, using a mixed regression model for repeated analyses (estimate = −0.931; standard error = 0.421; p = 0.027). The platelet count varied comparably in patients with BEVs and SEVs (estimate = −4.276, standard error = 4.760, p = 0.369). The average time for obtaining the nadir platelet count value was three days after implantation (BEV: 146 (108–181) vs. SEV: 149 (120–186); p = 0.142). Overall, 14.6% of patients (92/632) had post-procedural platelet count <100,000/µL. There was no difference between the two prosthesis types (BEV:51/316; SEV:41/316; p = 0.266). Thrombocytopenia was found to be significantly linked to blood product transfusions, lengthier stays in the intensive care unit and hospital, and in-hospital mortality. Conclusions: TAVI, irrespective of the type of implanted valve, is linked to a significant but temporary PR. Thrombocytopenia increases the risk of serious complications and in-hospital death in TAVI patients. To explore and clarify the causes and associated effects, further prospective research is necessary. [ABSTRACT FROM AUTHOR]

Background: Platelet count reduction (PR) is a common but unclear phenomenon that occurs after aortic bioprosthesis valve implantation (bio-AVR). This study aimed to investigate the occurrence and clinical impact of PR in patients receiving stented, rapid deployment (RDV), or stentless bioprostheses. Methods: 1233 adult bio-AVR patients were enrolled. Platelet count variation, early post-operative adverse events, and in-hospital mortality were analysed. Results: 944 patients received a stented valve, an RDV was implanted in 218 patients, and 71 patients had a stentless bioprosthesis. In all groups, the platelet count at discharge was lower than the baseline values (p < 0.001). The percentage of PR was 27% in the stented group, 56% in the RDV group, and 55% in the stentless group. A higher platelet reduction, reaching the minimum platelet value, was observed in the RDV (mean: −30.84, standard error (SE): 5.91, p < 0.001) and stentless (mean: 22.54, SE: 9.10, p = 0.03) groups compared to the stented group. A greater PR occurred as the size of the bioprosthesis increased in RDV (p = 0.01), while platelet count variation was not directly proportional to the stented bioprosthesis size (p < 0.001). PR was not affected by cardiopulmonary bypass (mean: −0.00, SE: 0.001, p = 0.635) or cross-clamp (mean: −0.00, SE: 0.002, p = 0.051) times in any of the groups. RDV subjects experienced more in-hospital adverse events. PR was found to be associated with ischemic strokes in the overall population. Conclusions: Bio-AVR is associated with significant but transient PR. RDV patients more likely experience significant PR and related adverse clinical events. PR is associated with ischemic strokes, regardless of the bioprosthesis type. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

OBJECTIVES To assess the impact of prosthesis choice and aortic valve calcifications on the occurrence of conduction disturbances after transcatheter aortic valve implantation (TAVI). METHODS We retrospectively analyzed the preoperative clinical characteristics, electrocardiograms, contrast-enhanced multidetector computed tomography scans and procedural strategies of patients who underwent TAVI in our center between January 2012 and June 2017. Quantification of calcium volume was performed for each aortic cusp above (aortic valve) and below (left ventricular outflow tract, LVOT) the basal plane. Multivariate analysis was performed to evaluate risk factors for the onset of new bundle branch block (BBB), transient and permanent atrioventricular block (tAVB, pAVB). RESULTS A total of 569 patients were included in the study. Six different prostheses were implanted (Edwards Sapien XT, n = 162; Edwards Sapien 3, n = 240; Medtronic CoreValve, n = 27; Medtronic CoreValve Evolut R, n = 21; Symetis Acurate, n = 56; Symetis Acurate neo, n = 63). The logistic regression analysis for BBB showed association with baseline left anterior hemiblock. The logistic regression for tAVB, found the prior valvuloplasty and the balloon post-dilatation associated with the outcome. Baseline left and right BBB, degree of oversizing, and LVOT calcification beneath the non-coronary cusp were associated with pAVB. Neither the prosthesis model, nor the use of a self-expandable prosthesis showed statistical significance with the above-mentioned outcomes on univariate analysis. CONCLUSIONS LVOT calcification beneath the non-coronary cusp, baseline left anterior hemiblock, right BBB, balloon post-dilatation, prior valvuloplasty and oversizing are independently associated with postprocedural conduction disturbances after TAVI. Use of a self-expandable prosthesis may show a lower incidence of AVB, if applied in lower calcified aortic valves. [ABSTRACT FROM AUTHOR]

Open in new tab Download slide Open in new tab Download slide 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. [ABSTRACT FROM AUTHOR]

The Valve Academic Research Consortium (VARC) criteria have been widely adopted to standardize definitions and reporting of TAVI-related complications, including access site vascular complications associated with increased mortality rates, prolonged hospitalization, and higher healthcare costs [[3]]. Keywords: Transcatheter aortic valve implantation; Vascular complications; Femoral access; Valve Academic Research Consortium criteria EN Transcatheter aortic valve implantation Vascular complications Femoral access Valve Academic Research Consortium criteria 1 2 2 09/05/23 20230801 NES 230801 Transcatheter aortic valve implantation (TAVI) has revolutionized the management of severe aortic stenosis. [Extracted from the article]

Introduction Despite increased operative time, minimally invasive cardiac surgery is associated with a lower morbidity than conventional aortic valve replacement (AVR). On the other hand, sutureless aortic bioprostheses have the potential of simplifying implantation, as it reduces the ischemic time. Our aim was to investigate the outcome of a sutureless AVR through a mini-sternotomy. Materials and Methods Since March 2010, a total of 262 patients affected by aortic valve stenosis underwent AVR with a sutureless bioprosthesis (Perceval, Sorin Group, Saluggia, Italy). Of these, 145 patients (mean age 77.8 ± 4.7 years, 80 women) underwent surgical AVR through a mini J-sternotomy. Clinical and echocardiographic data were evaluated. Results Patients received a size: S(12), M(49), L(67), or XL(17) prostheses, either as isolated (131) or combined procedures (14) including 2 redo patients who had undergone coronary artery bypass grafting via full sternotomy previously. Mean logistic EuroSCORE (I) was 9.9 ± 5.9%, and mean aortic cross-clamp time was 38 ± 12 minutes (35 ± 11 minutes in isolated procedures). Two conversions to full sternotomy were necessary because of bleeding. Thirty-day mortality was 2.1% (all noncardiac deaths); mean hospital stay was 11.6 ± 4.9 days. We recorded 11 pacemaker implantations (7.6%). At follow-up (23.5 ± 14.4 months), five patients were dead (three noncardiac and two cardiac deaths). At echocardiographic control, mean transprosthetic gradients were as follows: 12.8 ± 4.9, 12.5 ± 4.5, 11.8 ± 4.7 mm Hg, postoperatively at 6 months, 1 year, and 2 years, respectively. No paravalvular leaks were recorded. Conclusion The sutureless bioprosthesis shows satisfactory clinical and hemodynamic results. Owing to its simple implantation technique, it represents a good support for minimally invasive access surgery via J-sternotomy. [ABSTRACT FROM AUTHOR]