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BACKGROUND: The present study is a sub-analysis of the multicenter, randomized PERSIST-AVR trial (PERceval Sutureless Implant versus Standard Aortic Valve Replacement) comparing the in-hospital and 1-year results of sutureless versus conventional stented bioprostheses in isolated surgical aortic valve replacement (SAVR) within two different surgical approaches: mini-sternotomy (MS) and full-sternotomy (FS).METHODS: A total of 819 patients (per-protocol population) underwent preoperative randomization to sutureless or stented biological valve at 47 centers worldwide. Sub-analysis on isolated SAVR was performed. Results were compared between sutureless and stented within the two different surgical approaches.RESULTS: 285 patients were implanted with Perceval (67% in MS) and 293 with stented valves (65% in MS). Sutureless group showed significantly reduced surgical times both in FS and MS. In-hospital results show no differences between Perceval and stented valves in FS, while a lower incidence of new-onset of atrial fibrillation (3.7% vs 10.8%) with Perceval in MS. After 1-year, use of sutureless valve showed a significant reduction of MACCE (5.2% vs 10.8%), stroke rate (1.0% vs 5.4%), new-onset of atrial fibrillation (4.2% vs 11.4%) and re-hospitalizations (21.8 days vs 47.6 days), compared to stented valves but presented higher rate of pacemaker implantation (11% vs 1.6%).CONCLUSIONS: Sutureless bioprosthesis showed significantly reduced procedural times during isolated SAVR in both surgical approaches. Patients with sutureless valves and MS access showed also better 1-year outcome regarding MACCEs, stroke, re-hospitalization and new-onset atrial fibrillation, but presented a higher rate of permanent pacemaker implantation compared to patients with stented bioprosthesis.

BACKGROUND: This study compared clinical and hemodynamic in-hospital outcomes of patients undergoing sutureless vs rapid deployment aortic valve replacement (SURD-AVR) in the large population of the Sutureless and Rapid Deployment International Registry (SURD-IR). METHODS: We examined 4695 patients who underwent isolated or combined SURD-AVR. The "sutureless" Perceval valve (LivaNova PLC, London, United Kingdom) was used in 3133 patients and the "rapid deployment" Intuity (Edwards Lifesciences, Irvine, CA) in 1562. Potential confounding factors were addressed by the use of propensity score matching. After matching, 2 well-balanced cohorts of 823 pairs (isolated SURD-AVR) and 467 pairs (combined SURD-AVR) were created. RESULTS: Patients who received Perceval and Intuity valves showed similar in-hospital mortality and rate of major postoperative complications. Perceval was associated shorter cross-clamp and cardiopulmonary bypass times. In the isolated SURD-AVR group, patients receiving Perceval were more likely to undergo anterior right thoracotomy incision. Postoperative transvalvular gradients were significantly lower for the Intuity valve compared with those of the Perceval valve, either in isolated and combined SURD-AVR. The Intuity valve was associated with a lower rate of postoperative mild aortic regurgitation. CONCLUSIONS: Our results confirm the safety and efficacy of SURD-AVR regardless of the valve type. The Perceval valve was associated with reduced operative times and increased anterior right thoracotomy incision. The Intuity valve showed superior hemodynamic outcomes and a lower incidence of postoperative mild aortic regurgitation. ispartof: ANNALS OF THORACIC SURGERY vol:114 issue:3 pages:758-+ ispartof: location:Netherlands status: published

BACKGROUND: Post-acute myocardial infarction papillary muscle rupture (post-AMI PMR) may present variable clinical scenarios and degree of emergency due to result of cardiogenic shock. Veno-arterial extracorporeal life support (V-A ECLS) has been proposed to improve extremely poor pre- or postoperative conditions. Information in this respect is scarce. METHODS: From the CAUTION (meChanical complicAtion of acUte myocardial infarcTion: an InternatiOnal multiceNter cohort study) database (16 different Centers, data from 2001 to 2018), we extracted adult patients who were surgically treated for post-AMI PMR and underwent pre- or/and postoperative V-A ECLS support. The end-points of this study were in-hospital survival and ECLS complications. RESULTS: From a total of 214 post-AMI PMR patients submitted to surgery, V-A ECLS was instituted in 23 (11%) patients. The median age was 61.7 years (range 46-81 years). Preoperatively, ECLS was commenced in 10 patients (43.5%), whereas intra/postoperative in the remaining 13. The most common V-A ECLS indication was post-cardiotomy shock, followed by preoperative cardiogenic shock and cardiac arrest. The median duration of V-A ECLS was 4 days. V-A ECLS complications occurred in more than half of the patients. Overall, in-hospital mortality was 39.2% (9/23), compared to 22% (42/219) for the non-ECLS group. CONCLUSIONS: In post-AMI PMR patients, V-A ECLS was used in almost 10% of the patients either to promote bridge to surgery or as postoperative support. Further investigations are required to better evaluate a potential for increased use and its effects of V-A ECLS in such a context based on the still high perioperative mortality. ispartof: ARTIFICIAL ORGANS ispartof: location:United States status: Published online

OBJECTIVES Papillary muscle rupture (PMR) is a rare but potentially fatal complication of acute myocardial infarction. The aim of this study was to analyse the patient characteristics and early outcomes of the surgical management of post-infarction PMR from an international multicentre registry. METHODS Patients underwent surgery for post-infarction PMR between 2001 through 2019 were retrieved from database of the CAUTION study. The primary end point was in-hospital mortality. RESULTS A total of 214 patients were included with a mean age of 66.9 (standard deviation: 10.5) years. The posteromedial papillary muscle was the most frequent rupture location (71.9%); the rupture was complete in 67.3% of patients. Mitral valve replacement was performed in 82.7% of cases. One hundred twenty-two patients (57%) had concomitant coronary artery bypass grafting. In-hospital mortality was 24.8%. Temporal trends revealed no apparent improvement in in-hospital mortality during the study period. Multivariable analysis showed that preoperative chronic kidney disfunction [odds ratio (OR): 2.62, 95% confidence interval (CI): 1.07–6.45, P = 0.036], cardiac arrest (OR: 3.99, 95% CI: 1.02–15.61, P = 0.046) and cardiopulmonary bypass duration (OR: 1.01, 95% CI: 1.00–1.02, P = 0.04) were independently associated with an increased risk of in-hospital death, whereas concomitant coronary artery bypass grafting was identified as an independent predictor of early survival (OR: 0.38, 95% CI: 0.16–0.92, P = 0.031). CONCLUSIONS Surgical treatment for post-infarction PMR carries a high in-hospital mortality rate, which did not improve during the study period. Because concomitant coronary artery bypass grafting confers a survival benefit, this additional procedure should be performed, whenever possible, in an attempt to improve the outcome. Clinical trial registration clinicaltrials.gov: NCT03848429.

Left ventricular free-wall rupture (LVFWR) is an uncommon but serious mechanical complication of acute myocardial infarction (AMI). Surgical repair, though challenging, is the only definitive treatment. However, given the rarity of this condition, results following surgery are still not well established. The aim of this study was to review a multicenter experience with the surgical management of post-infarction LVFWR and analyze the associated early outcomes. Background: Left ventricular free-wall rupture (LVFWR) is an uncommon but serious mechanical complication of acute myocardial infarction. Surgical repair, though challenging, is the only definitive treatment. Given the rarity of this condition, however, results after surgery are still not well established. The aim of this study was to review a multicenter experience with the surgical management of post-infarction LVFWR and analyze the associated early outcomes. Methods: Using the CAUTION (Mechanical Complications of Acute Myocardial Infarction: an International Multicenter Cohort Study) database, we identified 140 patients who were surgically treated for post–acute myocardial infarction LVFWR in 15 different centers from 2001 to 2018. The main outcome measured was operative mortality. Multivariate analysis was carried out by constructing a logistic regression model to identify predictors of postoperative mortality. Results: The mean age of patients was 69.4 years. The oozing type of LVFWR was observed in 79 patients (56.4%), and the blowout type in 61 (43.6%). Sutured repair was used in the 61.4% of cases. The operative mortality rate was 36.4%. Low cardiac output syndrome was the main cause of perioperative death. Myocardial rerupture after surgery occurred in 10 patients (7.1%). Multivariable analysis revealed that preoperative left ventricular ejection fraction (P

OBJECTIVES Aortic valve replacement with a sutureless prosthesis [sutureless aortic valve replacement (Su-AVR)] is an option for patients with severe aortic valve stenosis. However, data regarding long-term outcomes and prosthesis durability are still lacking. METHODS All consecutive patients who successfully underwent Su-AVR with the Perceval valve in our centre between 2010 and 2020 were included in the analysis and followed prospectively with echocardiography. Risk factor analysis was performed to assess variables associated with worse survival and bioprosthetic valve failure. RESULTS Study population consisted of 547 patients: the mean age was 76.4 (5.2) years, 51% were female and the mean logistic EuroSCORE was 13% (11). The median survival was 7.76 years [95% confidence interval (CI) = 6.9–8.6]. Risk factor analysis identified age [hazard ratio (HR) 1.06, 95% CI 1.03–1.11; P CONCLUSIONS The sutureless valve represents a reliable bioprosthesis for aortic valve replacement in patients with a 10-year life expectancy. Younger age at the time of implant is the only factor associated with the risk of long-term SVD.

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 Conclusions 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.

OBJECTIVES This study aims to improve early detection of cardiac surgery-associated acute kidney injury (CSA-AKI) compared to classical clinical scores. METHODS Data from 7633 patients who underwent cardiac surgery between 2008 and 2018 in our institution were analysed. CSA-AKI was defined according to the Kidney Disease Improving Global Outcomes (KDIGO) criteria. Cleveland Clinical Score served as the reference with an area under the curve (AUC) 0.65 in our cohort. Based on that, stepwise logistic regression modelling was performed on the training data set including creatinine (Cr), estimated glomerular filtration rate (eGFR) levels and deltas (ΔCr, ΔeGFR) at different time points and clinical parameters as preoperative haemoglobin, intraoperative packed red blood cells (units) and cardiopulmonary bypass time (min) to predict CSA-AKI in the early postoperative course. The AUC was determined on the validation data set for each model respectively. RESULTS Incidence of CSA-AKI in the early postoperative course was 22.4% (n = 1712). The 30-day mortality was 12.5% in the CSA-AKI group (n = 214) and in the no-CSA-AKI group 0.9% (n = 53) (P CONCLUSIONS Model DynaLab’ improves early detection of CSA-AKI within 12 h after surgery. This simple Cr-based framework poses a fundament for further endeavours towards reduction of CSA-AKI incidence and severity.

OBJECTIVES This study aims to investigate the incidence and determinants of major early adverse events in low-risk patients undergoing isolated coronary artery bypass grafting (CABG). METHODS The multicentre E-CABG registry included 7352 consecutive patients who underwent isolated CABG from January 2015 to December 2016. Patients with an European System for Cardiac Operative Risk Evaluation (EuroSCORE) II of RESULTS Out of 2397 low-risk patients, 11 (0.46%) died during the index hospitalization or within 30 days from surgery. Five deaths were cardiac related, 4 of which were secondary to technical failures. We estimated that 8 out of 11 deaths were potentially preventable. Logistic regression model identified porcelain aorta [odds ratio (OR) 34.3, 95% confidence interval (CI) 1.3–346.3] and E-CABG bleeding grades 2–3 (OR 30.2, 95% CI 8.3–112.9) as independent predictors of hospital death. CONCLUSIONS Mortality and major complications, although infrequently, do occur even in low-risk patients undergoing CABG. Identification of modifiable causes of postoperative adverse events may be useful to develop preventative strategies to improve the quality of care of patients undergoing cardiac surgery. Clinical Trial Registration NCT02319083 (https://clinicaltrials.gov/ct2/show/NCT02319083).

OBJECTIVES Current evidence on sutureless and rapid deployment aortic valve replacement (SURD-AVR) is limited and does not allow for the assessment of the clinical impact and the evolution of procedural and clinical outcomes of this new valve technology. The Sutureless and Rapid Deployment International Registry (SURD-IR) represents a unique opportunity to evaluate the current trends and outcomes of SURD-AVR interventions. METHODS Data from 3682 patients enrolled between 2007 and 2018 were analysed. Patients were divided according to the date of surgery into 6 equal groups and by the type of intervention: isolated SURD-AVR (n = 2472) and combined SURD-AVR (n = 1086). RESULTS Across the 11-year study period, significant changes occurred in patient characteristics including a decrease in age and in estimated surgical risk. Less invasive approaches for isolated SURD-AVR increased considerably from 49.4% to 85.5%. The overall in-hospital mortality rate was 1.6% and 3.9% in isolated and combined procedures, respectively, with no change over time. The rate of perioperative stroke decreased significantly (from 4% to 0.5%), as did the rates of postoperative pacemaker implantation (from 12.8% to 5.9%) and aortic regurgitation (from 17.8% to 2.7%). CONCLUSIONS The present study provides a comprehensive analysis of the current trends and results of SURD-AVR interventions. The most notable changes over time were the increasing implantation of SURD valves in a younger population, with more frequent utilization of less invasive techniques. SURD-AVR demonstrated remarkable improvements in clinical outcomes with a significant reduction in the rates of stroke, pacemaker implantation and postoperative aortic regurgitation.

Aortic valve replacement with a sutureless prosthesis (Su-AVR) is an option for patients with severe aortic valve stenosis. However, data regarding long-term outcomes and prosthesis durability are still lacking.All consecutive patients who successfully underwent Su-AVR with the Perceval valve in our center between 2010 and 2020 were included in the analysis and followed prospectively with echocardiography. Risk factor analysis was performed to assess variables associated with worse survival and bioprosthetic valve failure.Study population consisted of 547 patients: mean age was 76.4 (5.2) years, 51% were female, and mean logistic EuroSCORE was 13% (11). The median survival was 7.76 years (95% CI = 6.9-8.6). Risk factor analysis identified age (hazard ratio [HR] 1.06, 95% confidence interval [CI] 1.03-1.11; p 0.001), EuroSCORE II (HR 1.08, 1.02-1.13; p 0.001), baseline dialysis (HR 2.14, 95% CI 1.4-4.4; p = 0.038) and postoperative acute kidney injury ≥2 (HR 8.97, 95% CI 4.58-17.6; p 0.001) as factors significantly correlated with worse survival. The reported HRs for age are per one year and for EuroSCORE II is one percentage point. Structural valve deterioration (SVD) was observed in 23 patients, of which 19 underwent reintervention (median freedom from SVD 10.3 years). In multivariable Cox analysis, age (HR 0.89, 95% CI 0.82-0.95; p 0.001) was found to be a significant predictor of SVD. Overall, 1.8% was referred for prosthetic valve endocarditis (confirmed or suspected) during follow-up. One patient showed moderate non-SVD and none developed prosthetic valve thrombosis.The sutureless valve represents a reliable bioprosthesis for AVR in patients with a 10-year life expectancy. Younger age at time of implant is the only factor associated with the risk of long-term SVD.

To assess the impact of prosthesis choice and aortic valve calcifications on the occurrence of conduction disturbances after transcatheter aortic valve implantation (TAVI).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).A total of 569 patients were included in the study. Six different prostheses were implanted (Edwards Sapien XT,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.

Background. Occluding the left atrial appendage (LAA) during cardiac surgery reduces the risk of ischemic stroke; nonetheless, it is currently only softly recommended with “may be considered” by the current guidelines. We aimed to assess thromboembolic risk after LAA amputation in patients with atrial fibrillation (AF) and aortic stenosis undergoing biological aortic valve replacement (AVR) as primary cardiac surgery. Methods. Two cohorts were generated retrospectively: patients with AF undergoing AVR alone or combined with revascularization either with LAA amputation or without. Data were collected from the hospital-specific data system. Follow-up was completed by telephone interview or in person. Thirty-day and follow-up results were compared in patients with vs. without LAA amputation. Results. One hundred and fifty-seven patients were investigated retrospectively, and seventy-four pairs were matched with regard to baseline characteristics. Patients with LAA amputation exhibited a lower incidence of cumulative and late ischemic stroke (6.4% vs. 25%, p = 0.028 and 3.2% vs. 20%, p = 0.008, respectively; hazard ratio 0.30; 95% confidence interval 0.11; 0.84; p = 0.021) during follow-up of 48 months vs. patients without intervention during follow-up of 45 months, p = 0.494. No significant differences were observed in postoperative stroke, 2 (2.7%) vs. 3 (4.1%), p = 1.000, re-exploration for bleeding 3 (4.1%) vs. 6 (8.1), p = 0.494 or late pericardial effusion 2 (2.7%) vs. 3 (4.1%), p = 1.000, in-hospital 2 (2.7%) vs. 4 (5.4%), p = 0.681 and all-cause mortality 15 (23.8%) vs. 9 (15%), p = 0.315 in patients with vs. without LAA amputation, respectively. Conclusions. A combination of leading aortic stenosis and AF in patients undergoing isolated or combined biological AVR represents a subpopulation with excessive thromboembolic risk. Concomitant LAA amputation during cardiac surgery reduces the risk of ischemic stroke without posing an additional periprocedural risk for the patient. Therefore, the minimal invasive approach at the expense of omitting LAA amputation should be discouraged to maximize the clinical benefits of AVR in this setting.

OBJECTIVES Sutureless aortic valves demonstrated non-inferiority to standard stented valves for major cardiovascular and cerebral events at 1 year after aortic valve replacement. We aim to assess the factors correlating with permanent pacemaker implantation (PPI) in both cohorts. METHODS PERSIST-AVR is a prospective, randomized, open-label trial. Patients undergoing aortic valve replacement were randomized to receive a sutureless aortic valve replacement (Su-AVR) or stented sutured bioprosthesis (SAVR). Multivariable analysis was performed to identify possible independent risk factors associated with PPI. A logistic regression analysis was performed to estimate the risk of PPI associated to different valve size. RESULTS The 2 groups (Su-AVR; n = 450, SAVR n = 446) were well balanced in terms of preoperative risk factors. Early PPI rates were 10.4% in the Su-AVR group and 3.1% in the SAVR. PPI prevalence correlated with valve size XL (P = 0.0119) and preoperative conduction disturbances (P = 0.0079) in the Su-AVR group. No predictors were found in the SAVR cohort. Logistic regression analysis showed a significantly higher risk for PPI with size XL compared to each individual sutureless valve sizes [odds ratio (OR) 0.272 vs size S (95%confidence interval 0.07–0.95), 0.334 vs size M (95% CI 0,16–0; 68), 0.408 vs size L (95% CI 0,21–0.81)] but equivalent risk of PPI rates for all other combination of valve sizes. CONCLUSIONS Su-AVR is associated with higher PPI rate as compared to SAVR. However, the increased PPI rate appears to be size-dependent with significant higher rate only for size XL. The combination of preoperative conduction disorder and a size XL can lead to a higher probability of early PPI in Su-AVR. Clinical trial registration number NCT02673697.

OBJECTIVES To compare procedural and in-hospital outcomes of patients undergoing sutureless (Perceval, Livanova PLC, London, UK) and rapid deployment (Intuity Elite, Edwards Lifesciences, Irvine, CA, USA) aortic valve replacement (group 1) versus sutured aortic valve replacement (group 2). METHODS Patients receiving isolated aortic valve replacement between 2014 and 2020 were analysed using data from the Sutureless and Rapid Deployment International Registry. Patients in group 1 and group 2 were propensity-score matched in a 1:1 ratio. RESULTS A total of 7708 patients were included in the study. After matching, 2 groups of 2643 each were created. Patients in group 1 were more likely to undergo minimally invasive approaches and were associated with shorter operative times when compared with group 2. Overall in-hospital mortality was similar between groups. While an increased risk of stroke was observed in group 1 in the first study period (2014–2016; relative risk 3.76, P CONCLUSIONS Our findings showed significant differences in procedural and clinical outcomes between the study groups. These results suggest that sutureless and rapid deployment aortic valve replacement should be considered as part of a comprehensive valve programme. The knowledge of the respective post-aortic valve replacement benefits for different valve technologies may result in patient-tailored valve selection with improved clinical outcomes.

Degeneration of mitral prostheses/rings may be treated by redo surgery, and, recently, by transcatheter valve-in-valve/ring implantation. This multicenter registry presents results of transcatheter valve-in-valve and repeat surgery for prostheses/rings degeneration.Data provided by 10 German heart centers underwent propensity score-matched retrospective analysis. The primary endpoint was 30-day/midterm mortality. Perioperative outcome was assessed according to the Mitral Valve Academic Research Consortium criteria. Further, the influence of moderate or greater tricuspid regurgitation (TR) on 30-day/midterm mortality was analyzed.Between 2014 and 2019, 273 patients (79 transcatheter mitral valve-in-valve [TM-ViV] and 194 redo mitral valve replacement [Re-MVR]) underwent repeat procedure for mitral prosthesis/ring degeneration. Propensity score matching distinguished 79 patient pairs. European System for Cardiac Operative Risk Evaluation (EuroSCORE) II-predicted risk was 15.7 ± 13.7% in the TM-ViV group and 15.0% ± 12.7% in the Re-MVR group (P = .5336). TM-ViV patients were older (74.73 vs 72.2 years; P = .0030) and had higher incidence of atrial fibrillation (54 vs 40 patients; P = .0233). Severe TR incidence was similar (17.95% in TM-ViV vs 14.10%; P = .1741). Sixty-eight TM-ViV patients previously underwent mitral valve replacement, whereas 41 Re-MVR patients underwent valve repair (P .0001). Stenosis was the leading degeneration mechanism in 42 TM-ViV versus 22 Re-MVR patients (P .0005). The 30-day/midterm mortality did not differ between groups. Moderate or greater TR was a predictor of total (odds ratio [OR], 4.36; P = .0011), 30-day (OR, 3.76; P = .0180), and midterm mortality (OR, 4.30; P = .0378), irrespective of group.In both groups, observed mortality was less than predicted. Redo surgery enabled treatment of concomitant conditions, such as atrial fibrillation or TR. TR was shown to be a predictor of total, 30-day, and midterm mortality in both groups.

OBJECTIVES This study aims to improve the early detection of cardiac surgery-associated acute kidney injury using artificial intelligence-based algorithms. METHODS Data from consecutive patients undergoing cardiac surgery between 2008 and 2018 in our institution served as the source for artificial intelligence-based modelling. Cardiac surgery-associated acute kidney injury was defined according to the Kidney Disease Improving Global Outcomes criteria. Different machine learning algorithms were trained and validated to detect cardiac surgery-associated acute kidney injury within 12 h after surgery. Demographic characteristics, comorbidities, preoperative cardiac status and intra- and postoperative variables including creatinine and haemoglobin values were retrieved for analysis. RESULTS From 7507 patients analysed, 1699 patients (22.6%) developed cardiac surgery-associated acute kidney injury. The ultimate detection model, ‘Detect-A(K)I’, recognizes cardiac surgery-associated acute kidney injury within 12 h with an area under the curve of 88.0%, sensitivity of 78.0%, specificity of 78.9% and accuracy of 82.1%. The optimal parameter set includes serial changes of creatinine and haemoglobin, operative emergency, bleeding-associated variables, cardiac ischaemic time and cardiac function-associated variables, age, diuretics and active infection, chronic obstructive lung and peripheral vascular disease. CONCLUSIONS The ‘Detect-A(K)I’ model successfully detects cardiac surgery-associated acute kidney injury within 12 h after surgery with the best discriminatory characteristics reported so far.

Key Points Question What are the early outcomes of surgical treatment of postinfarction ventricular septal rupture? Findings In this cohort study of 475 patients from 26 different centers worldwide, the early mortality rate for surgically treated ventricular septal rupture was 40.4%, mostly due to low cardiac output, and it did not improve in the last 2 decades. Meaning The findings of this study suggest that patient-tailored preoperative and perioperative management of postinfarction ventricular septal rupture should be addressed to improve the current suboptimal survival rates., This cohort study assesses the clinical characteristics and early outcomes for patients who received surgery for postinfarction ventricular septal rupture and identifies factors independently associated with mortality., Importance Ventricular septal rupture (VSR) is a rare but life-threatening mechanical complication of acute myocardial infarction associated with high mortality despite prompt treatment. Surgery represents the standard of care; however, only small single-center series or national registries are usually available in literature, whereas international multicenter investigations have been poorly carried out, therefore limiting the evidence on this topic. Objectives To assess the clinical characteristics and early outcomes for patients who received surgery for postinfarction VSR and to identify factors independently associated with mortality. Design, Setting, and Participants The Mechanical Complications of Acute Myocardial Infarction: an International Multicenter Cohort (CAUTION) Study is a retrospective multicenter international cohort study that includes patients who were treated surgically for mechanical complications of acute myocardial infarction. The study was conducted from January 2001 to December 2019 at 26 different centers worldwide among 475 consecutive patients who underwent surgery for postinfarction VSR. Exposures Surgical treatment of postinfarction VSR, independent of the technique, alone or combined with other procedures (eg, coronary artery bypass grafting). Main Outcomes and Measures The primary outcome was early mortality; secondary outcomes were postoperative complications. Results Of the 475 patients included in the study, 290 (61.1%) were men, with a mean (SD) age of 68.5 (10.1) years. Cardiogenic shock was present in 213 patients (44.8%). Emergent or salvage surgery was performed in 212 cases (44.6%). The early mortality rate was 40.4% (192 patients), and it did not improve during the nearly 20 years considered for the study (median [IQR] yearly mortality, 41.7% [32.6%-50.0%]). Low cardiac output syndrome and multiorgan failure were the most common causes of death (low cardiac output syndrome, 70 [36.5%]; multiorgan failure, 53 [27.6%]). Recurrent VSR occurred in 59 participants (12.4%) but was not associated with mortality. Cardiogenic shock (survived: 95 [33.6%]; died, 118 [61.5%]; P

Objective To report the early and mid-term results of patients who underwent minimally invasive aortic valve replacement (MI-AVR) with a sutureless prosthesis from an international prospective registry. Methods Between March 2011 and September 2018, among 957 patients included in the prospective observational SURE-AVR (Sorin Universal REgistry on Aortic Valve Replacement) registry, 480 patients underwent MI-AVR with self-expandable Perceval aortic bioprosthesis (LivaNova PLC, London, UK) in 29 international institutions through either minithoracotomy ( n = 266) or ministernotomy ( n = 214). Postoperative, follow-up, and echocardiographic outcomes were analyzed for all patients. Results Patient age was 76.1 ± 7.1 years; 64.4% were female. Median EuroSCORE I was 7.9% (interquartile range [IQR], 4.8 to 10.9). Median cardiopulmonary bypass and cross-clamp times were 81 minutes (IQR 64 to 100) and 51 minutes (IQR 40 to 63). First successful implantation was achieved in 97.9% of cases. Two in-hospital deaths occurred, 1 for noncardiovascular causes and 1 following a disabling stroke. In the early (≤30 days) period, stroke rate was 1.4%. Three early explants were reported: 2 due to nonstructural valve dysfunction (NSVD) and 1 for malpositioning. One mild and 1 moderate paravalvular leak were reported. In 16 patients (3.3%) pacemaker implantation was needed. Mean follow-up was 2.4 years (maximum = 7 years). During follow-up 5 explants were reported, 3 due to endocarditis and 2 due to NSVD. Follow-up stroke rate was 2.5%. Three structural valve deteriorations not requiring reintervention were reported. Five-year survival was 91.45%. Conclusions In this large prospective international registry, MI-AVR with Perceval valve confirmed to be safe, reproducible, and effective in an intermediate-risk population, providing excellent clinical recovery both in early and mid-term follow-up.

Objective As bicuspid aortic valve (BAV) repair evolves, more effective annular reduction and stabilization could be advantageous. A geometric annuloplasty ring has been developed, and 2-year regulatory outcomes of a first-in-humans pilot trial are reported. Methods A prospective first-in-humans trial of BAV ring annuloplasty was completed in 16 patients. Patient age was 44.4 ± 11.3 (mean ± standard deviation) years, preoperative aortic insufficiency grade was 2.5 ± 1.0, New York Heart Association class 1.8 ± 0.4, and mean systolic gradient 13.4 ± 12.9 mm Hg. Three patients had Sievers type 0 BAV, 11 had type 1, and 2 were type 2. The Dacron-covered titanium rings had circular base geometry with 180° subcommissural posts and were implanted subannularly. Leaflets were reconstructed using plication/cleft closure, creating an effective height of ≥8 mm, even if modest gradients were induced. Results Mean pre-repair annular diameter was 28.6 ± 3.3 mm, and the average ring diameter was 22.3 ± 1.6 mm. All valves required leaflet plication/reconstruction; pericardium was avoided; and 7 patients had aortic replacement for aneurysms. No early mortalities or major complications occurred. Two patients required early prosthetic valve replacement for technical errors, and all were between 24-38 months’ postoperative at follow-up. No late mortalities or valve-related complications occurred, and all patients reverted to New York Heart Association class I. Aortic insufficiency reduction was significant to grade 0.9 ± 0.5 at 2-years (P

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

Background: Cardiac surgery in patients with infective endocarditis (IE) is still associated with high mortality and morbidity; an already present inflammation might further be aggravated due to a cardiopulmonary bypass-induced dysregulated immune response. Intraoperative hemoadsorption therapy may attenuate this septic response. Our objective was therefore to assess the efficacy of intraoperative hemoadsorption in active left-sided native- and prosthetic infective endocarditis. Methods: Consecutive high-risk patients with active left-sided infective endocarditis were enrolled between January 2015 and April 2021. Patients with intraoperative hemoadsorption (Cytosorbents, Princeton, NJ, USA) were compared to patients without hemoadsorption (control). Endpoints were the incidence of postoperative sepsis, sepsis-associated death and in-hospital mortality. Predictors for sepsis-associated mortality and in-hospital mortality were analysed by multivariable logistic regression. Results: A total of 202 patients were included, 135 with active left-sided native and 67 with prosthetic valve infective endocarditis. Ninety-nine patients received intraoperative hemoadsorption and 103 patients did not. Ninety-nine propensity-matched pairs were selected for final analyses. Postoperative sepsis and sepsis-related mortality was reduced in the hemoadsorption group (22.2% vs. 39.4%, p = 0.014 and 8.1% vs. 22.2%, p = 0.01, respectively). In-hospital mortality tended to be lower in the hemoadsorption group (14.1% vs. 26.3%, p = 0.052). Key predictors for sepsis-associated mortality and in-hospital mortality were preoperative inotropic support, lactate-levels 24 h after surgery, C-reactive protein levels on postoperative day 1, chest tube output, cumulative inotropes and white blood cell counts on postoperative day 2, and new onset of dialysis. Multivariate regression analysis revealed intraoperative hemoadsorption to be associated with lower sepsis-associated (OR 0.09, 95% CI 0.013–0.62, p = 0.014) as well as in-hospital mortality (OR 0.069, 95% CI 0.006–0.795, p = 0.032). Conclusions: Intraoperative hemoadsorption holds promise to reduce sepsis and sepsis-associated mortality after cardiac surgery for active left-sided native and prosthetic valve infective endocarditis.

Background: The vascular access in transcatheter aortic valve replacement (TAVR) was initially dominated by a surgical approach. Meanwhile, percutaneous closure systems became a well-established alternative. The aim of this study was to compare the clinical outcome between the two approaches. Methods: In this retrospective study, we observed 787 patients undergoing a TAVR-Procedure between 2013 and 2019. Of those, 338 patients were treated with surgical access and 449 with the Perclose ProGlide™-System (Abbott, Chicago, IL, USA). According to the Bleeding Academic Research Consortium (BARC) and Valve Academic Research Consortium (VARC) criteria, the primary combined endpoints were defined. Results: Overall hospital mortality was 2.8% with no significant difference between surgical (3.8%) and percutaneous (2.2%) access (p = 0.182). Major vascular complications or bleeding defined as the primary combined endpoint was not significantly different in either group (Surgical group 5.3%, ProGlide group 5.1%, p = 0.899). In the ProGlide group, women with pre-existing peripheral artery disease (PAD) were significantly more often affected by a vascular complication (p = 0.001 for female sex and p = 0.03 for PAD). Conclusions: We were able to show that the use of both accesses is safe. However, the surgical access route should also be considered in case of peripheral artery disease.

Infective endocarditis (IE) is nowadays one of the most challenging disease in cardiac surgery because of its multifaceted clinical and anatomical presentation. Despite the many clinical and surgical advances achieved in the past 60 years, there is a lack of evidence regarding the ideal strategy. The present review aims to investigate and highlight two main novel concepts for the decision-making of the best substitute. Firstly, the concept of an "endocarditis team": a coordinated multidisciplinary effort in the diagnostic work-up, especially in conditions of high risk of embolization or clinical deterioration. A good "endocarditis team" has the role to overcome such problem, in order to ensure a prompt and balanced strategy. Secondly, which ethical considerations are required to drive the choice of valvular substitute. The choice of best valve substitute is a relevant issue of debate, not only with operative but also prognostic and accordingly ethical aftermaths. Many different solutions have been developed to substitute the infected valve. Among these: mechanical prosthesis (MP), biological stented prosthesis (BP), sutureless bioprosthesis and cryopreserved homografts (CHs). Patients need to be informed in detail about the technical issues pertaining the use of these valve substitute. We will discuss the evidences regarding the risk of recurrent infections or future potentially severe calcification of aortic homograft valve and wall (in other words, the failure of the homograft) and the difficulties in managing the reoperation.

Background Calcification of native aortic valve is a well known variable causing paravalvular leakage (PVL) following transcatheter aortic valve implantation (TAVI). However, there is currently no evidence to support the fact that patients with high calcium load could be better treated with surgical aortic valve replacement (SAVR). Purpose To assess the utility of preoperative assessment of valvular calcium load through computed tomography in patients affected by severe aortic valve stenosis undergoing SAVR or TAVI. Methods Between June 2016 and June 2018, 109 candidates for isolated SAVR through minimal invasive access underwent preoperative contrast enhanced multidetector computed tomography (MDCT) for the assessment of valve and aortic calcifications. Calcium load was quantitatively measured using a dedicated software in three regions on interest (aortic valve [AV], left ventricular outflow tract [LVOT] and device landing zone [DLZ], which is the sum of the earlier 2). Clinical, echocardiographic, and MDCT variables were collected and compared to a sample population of 107 patients that underwent TAVI (87 transfemoral, 20 transapical) for native aortic valve stenosis in the same period of time, in the same institution. A univariate and multivariate logistic regression analysis were performed on the whole study population to assess risk factors for the onset of postoperative PVL (any grade, defined as ≥ mild) at discharge. Results The two study groups were significantly different in terms of age (71.9±5 in SAVR; 81.5±6 in TAVI), gender (36% female in SAVR vs 51% in TAVI), Euroscore II (1.9%±0.8 in SAVR; 4.8%±2.7 in TAVI), annulus perimeter (79.5mm±8.2 in SAVR; 61.8mm±30.5 in TAVI), baseline ejection fraction (57%±8 in SAVR; 51%±12 in TAVI) and severe pulmonary hypertension (2%±13 in SAVR; 26%±44 in TAVI). Calcium load was not different between groups (DLZ 1066 mm3±716 vs 955mm3±639; total calcium in AV 987 mm3±678 vs 879 mm3±601; total calcium in LVOT 78 mm3±130 vs 77 mm3±100). 30-days-mortality was 1.8% in SAVR and 5.6% in TAVI group (p=0.17). At discharge, incidence of all grades PVL was 5.5% in SAVR (0.9% trace, 3.6% mild, 0.9% moderate) and 41% in TAVI group (12.1% trace, 25.2% mild, 3.7% moderate) (p Conclusions Aortic valve calcifications are a risk factor for the onset of PVL for both TAVI and SAVR. Nevertheless, the risk increases considerably with the use of TAVI. A deeper anatomical analysis of preoperative MDCT could improve the treatment selection and the outcome of patients affected by aortic valve stenosis. Funding Acknowledgement Type of funding source: None

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.

BACKGROUND: Benefits of sutureless and rapid deployment (SURD) bioprostheses in bicuspid aortic valves (BAV) are controversial. The aim of this study is to report the outcomes of patients undergoing aortic valve replacement (AVR) for BAV from the Sutureless and Rapid-Deployment Aortic Valve Replacement International Registry (SURD-IR). METHODS: Of the 4,636 patients who received primary isolated SURD-AVR between 2007 and 2018, 191 (4.1%) BAV patients underwent AVR with SURD valve. RESULTS: Overall 30-day mortality was 1.6%. The Intuity valve was implanted in 53.9% of cases, whereas the Perceval was implanted in 46.1%. Rate of stroke for isolated AVR was 4.2%. No case of endocarditis, thromboembolism, myocardial infarction, valve dislocation or structural valve deterioration was reported in the early phase. Rate of pacemaker implantation and moderate-severe aortic regurgitation (AR) were 7.9% and 3.7%, respectively. CONCLUSIONS: BAV is not considered a contraindication for the implantation of SURD valves. However, detailed information of aortic root geometry as well as the knowledge of some technical considerations are mandatory for a good outcome. ispartof: ANNALS OF CARDIOTHORACIC SURGERY vol:9 issue:4 pages:298-304 ispartof: location:China status: published

OBJECTIVES: The impact of sutureless and rapid deployment (SURD) valves on the clinical outcomes of patients undergoing minimally invasive aortic valve replacement (MI-AVR) has still to be defined. The aim of this study was to assess clinical characteristics and in-hospital results of patients receiving SURD-AVR through less invasive approaches in the large population of the Sutureless and Rapid Deployment International Registry (SURD-IR). METHODS: Of the 1935 patients who received primary isolated SURD-AVR between 2009 and 2018, a total of 1418 (73.3%) underwent MI interventions and were included in this analysis. SURD-AVR was performed using upper ministernotomy in 56.4% (n = 800) of cases and anterior right thoracotomy in 43.6% (n = 618). Perceval S was implanted in 1011 (71.3%) patients and Edwards Intuity or Intuity Elite in 407 (28.7%) patients. RESULTS: Overall in-hospital mortality and stroke rates were 1.7% and 2%, respectively. A definitive pacemaker implantation was reported in 9% of cases and significantly decreased over the observational period, from 20.6% to 5.6% (P = 0.002). The Perceval valve was associated with shorter operative times and was more frequently implanted in patients receiving anterior right thoracotomy incision. The Intuity valve was preferred in younger patients and revealed superior postoperative haemodynamic results. CONCLUSIONS: SURD-AVR was largely performed through less invasive approaches and can be considered as a primary indication in MI surgery. In the SURD-IR cohort, MI SURD-AVR using both Perceval and Intuity valves appeared a safe and reproducible procedure associated with promising early results.

International audience; 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.

Summary The antiplatelet agent ticagrelor has recently been found to have bactericidal activity, demonstrated in vitro and in an in vivo mouse model, which warrants further clinical investigations. The aim of this study was to evaluate infectious complications after coronary artery bypass grafting in patients pre-operatively treated with ticagrelor or clopidogrel. In a multi-centre trial, all adult patients who were pre-operatively treated with ticagrelor or clopidogrel prior to isolated primary coronary artery bypass grafting were eligible. Propensity score matching was used. Outcome measures were any sternal wound infection, deep sternal wound infection, and any in-hospital use of postoperative antibiotics. Of 2311 patients who were included, 1293 (55.9%) received clopidogrel and 1018 (44.1%) ticagrelor pre-operatively. In both overall and propensity score matched analyses, ticagrelor was associated with a similar incidence of infectious complications compared to clopidogrel. Our findings do not support a clinically relevant bactericidal effect of ticagrelor in patients undergoing coronary artery bypass grafting.