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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

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 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.

Objective In chronic aortic insufficiency (AI), the method and degree of annular downsizing required to achieve durable coaptation in aortic valve repair (AVr) remains poorly defined. This study evaluated the relationship between leaflet size and annular diameter to predict adequate annular sizing in remodeling AVr. Methods Under regulatory supervision, 74 patients with chronic tri-leaflet AI underwent AVr using ring annuloplasty and leaflet reconstruction. Fifty-four (73%) had ascending aortic ( n = 25) and/or root ( n = 29) aneurysms, and aortic grafts were sized 5 to 7 mm larger than the rings. Intraoperatively, leaflet free-edge length (FEL) was measured with special ball sizers positioned in the coronary sinus, and “normal” annular diameter was predicted from the validated formula: Required “normal” diameter = FEL/1.5. “Normal” annular diameters predicted from FEL were compared with pathologic diameters measured intraoperatively with Hegar dilators, and both were correlated with gender, age, and BSA. Results Average age was 62.1 ± 13.3 years (mean ± SD), 73% (54/74) were male, and 96% (71/74) had moderate-to-severe AI. All patients had annular dilatation, with a pathologic diameter 26.6 ± 2.3 mm before repair, and a predicted “normal” diameter of 21.7 ± 1.7 mm ( P < 0.001). Both predicted and pathologic annular diameters were larger in men ( P < 0.001), but no relationship existed with age. BSA correlated with both predicted and pathologic diameters, although variability was large. Conclusions Based on a simple validated method to predict “normal” annular diameter, all patients with chronic AI have some degree of annular dilatation. This finding implies that most AVr should include annuloplasty, with adequate and precise annular reduction based on leaflet size.

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.

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

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.

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.

Indications for TF-TAVI (transfemoral transcatheter aortic valve implantation) are rapidly changing according to increasing evidence from randomized controlled trials. Present trials document the non-inferiority or even superiority of TF-TAVI in intermediate-risk patients (STS-Score 4–8%) as well as in low-risk patients (STS-Score

Background Changes in cardiac autonomic regulation and P-wave characteristics are associated with the occurrence of atrial fibrillation. The purpose of this study was to evaluate whether combined preoperative non-invasive determination of cardiac autonomic regulation and PR interval allows for the identification of patients at risk of new-onset atrial fibrillation after cardiac surgery. Methods RR, PR and QT intervals, and linear and non-linear heart rate variability parameters from 20 min high-resolution electrocardiographic recordings were determined one day before surgery in 150 patients on chronic beta blockers undergoing elective coronary artery bypass grafting, aortic valve replacement, or both, electively. Results Thirty-one patients (21%) developed postoperative atrial fibrillation. In the atrial fibrillation group, more arterial hypertension, a greater age, a higher EuroSCORE II, a higher heart rate variability index (pNN50: 9 ± 20 vs. 4 ± 10, p = 0.050), a short PR interval (156 ± 23 vs. 173 ± 31 ms; p = 0.011), and a reduced short-term scaling exponent of the detrended fluctuation analysis (DFA1, 0.96 ± 0.36 vs. 1.11 ± 0.30 ms; p = 0.032) were found compared to the sinus rhythm group. Logistic regression modeling confirmed PR interval, DFA1 and age as the strongest preoperative predictors of postoperative atrial fibrillation (area under the receiver operating characteristic curve = 0.804). Conclusions Patients developing atrial fibrillation after cardiac surgery presented with severe cardiac autonomic derangement and a short PR interval preoperatively. The observed state characterizes both altered heart rate regulation and arrhythmic substrate and is strongly related to an increased risk of postoperative atrial fibrillation.

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.

OBJECTIVES As aortic valve repair (AVr) for aortic insufficiency (AI) expands, minimally invasive (Mi) approaches are increasingly being applied. Cardiac surgical techniques can be more difficult through small incisions, and this report analyzes medium-term outcomes for MiAVr facilitated by geometric ring annuloplasty. METHODS Since 2013, 58 patients were selected for AVr through upper sternotomy third-interspace incisions. The average age was 58.9 ± 15.4 (mean ± SD) years, 71% were male, and preoperative AI grade was 3.6 ± 0.8. Sixty-two percent (36/58) had a proximal aortic replacement for ascending aortic aneurysms (n = 26) and/or remodeling grafts for aortic root aneurysms (n = 10). Annuloplasty rings were placed subannularly (69% trileaflet; 31% bicuspid), and leaflet procedures were performed in 70%. The average ring diameter was 21.6 ± 1.4 mm, and the average aortic clamp time was 113 ± 35 min. RESULTS After repair, AI grade fell to an average of 0.5 ± 0.6 (p

AIMS Sutureless valves became an alternative to standard bioprostheses, allowing surgeons to significantly reduce cross-clamping and extracorporeal circulation times, with a potential positive impact on major postoperative complications. The aim of this European multicentre study was to evaluate the safety and efficacy of sutureless valves in patients with an intermediate-risk profile undergoing aortic valve replacement (AVR). METHODS We investigated early and mid-term outcomes of 518 elderly patients with aortic stenosis at intermediate-risk profile (mean STS Score 6.1 ± 2%) undergoing AVR with sutureless aortic valve. Primary endpoints were 30-day mortality and freedom from all-cause death at follow-up. The secondary endpoint was survival freedom from MACCEs [all-cause death, stroke/transitory ischemic attack (TIA), bleeding, myocardial infarction, aortic regurgitation Grade II, endocarditis, reintervention and pacemaker implant; VARC 1--2 criteria]. RESULTS Sutureless valve implantation was successfully performed in 508 patients, with a procedural success rate of 98.1% (508/518) as per VARC criteria. Concomitant myocardial revascularization [coronary artery bypass grafting (CABG)] was performed in 74 out of 518 patients (14.3%). In-hospital mortality was 1.9% (10/518). Postoperative complications included revision for bleeding (23/518; 4.4%), prolonged intubation more than 48h (4/518; 0.7%), acute renal failure (14/518; 2.7%), stroke/TIA (11/518; 2.1%), pacemaker implantation (26/518; 5.1%) and aortic regurgitation more than Grade II (7/518; 1.4%). At 48-month follow-up, Kaplan-Meier overall survival and freedom from MACCEs in patients receiving isolated AVR were 83.7% [95% confidence interval (95% CI): 81.1-86.3] and 78.4% (95% CI: 75.5-81.4), respectively, while in patients with concomitant CABG, Kaplan-Meier overall survival and freedom from MACCEs were 82.3% (95% CI: 73.3-91.3) and 79.1% (95% CI: 69.9-88.3), respectively. CONCLUSION The use of sutureless aortic valves in elderly patients with an intermediate-risk profile provided excellent early and mid-term outcomes, providing a reliable tool in patients undergoing surgical AVR in this specific subset of population. These preliminary data need to be investigated with a TAVI control-group in further studies.

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.

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.

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.

Background: Patients with increased glycated hemoglobin (HbA1c) seem to be at increased risk of sternal wound infection (SWI) after coronary artery bypass grafting (CABG). However, it is unclear whether increased baseline HbA1c levels may affect other postoperative outcomes. Material and methods: Data on preoperative levels of HbA1c were collected from 2606 patients undergoing elective isolated CABG from 2015 to 2016 and included in the prospective, multicenter E-CABG registry. Results: The prevalence of HbA1c ≥ 53 mmol/mol (7.0%) among non-diabetics was 5.3%, among non-insulin dependent diabetics was 53.5% and among insulin dependent diabetics was 67.1% (p < 0.001). The prevalence of HbA1c > 75 mmol/mol (9.0%) among non-diabetics was 0.5%, among non-insulin dependent diabetics was 5.8% and among insulin dependent diabetics was 10.6% (p < 0.001). Baseline levels of HbA1c ≥ 53 mmol/mol (7.0%) was a significant predictor of any SWI (10.7% vs. 3.3%, adjusted p-value

Bilateral internal mammary artery (BIMA) grafting is increasingly used in the elderly without evidence of its risks or benefits compared to single internal mammary artery (SIMA) grafting. Background. Bilateral internal mammary artery (BIMA) grafting is increasingly used in elderly patients without evidence of its risks or benefits compared with single internal mammary artery (SIMA) grafting.Methods. In all, 2,899 patients aged 70 years or older (855 [29.5%] underwent BIMA grafting) operated on from January 2015 to December 2016 and included in the prospective multicenter Outcome After Coronary Artery Bypass Grafting (E-CABG) study were considered in this analysis.Results. One-to-one propensity matching resulted in 804 pairs with similar preoperative risk profile. Propensity score matched analysis showed that BIMA grafting was associated with a nonstatistically significant increased risk of inhospital death (2.7% versus 1.6%, p = 0.117). The BIMA grafting cohort had a significantly increased risk of any sternal wound infection (7.7% versus 5.1%, p = 0.031) as well as higher risk of deep sternal wound infection/mediastinitis (4.0% versus 2.2%, p = 0.048). The BIMA grafting cohort required more frequently extracorporeal membrane oxygenation (1.0% versus 0.1%, p = 0.02), and the intensive care unit stay (mean 3.6 versus 2.6 days, p < 0.001) and inhospital stay (mean 11.3 versus 10.0 days, p < 0.001) were significantly longer compared with the SIMA grafting cohort. Test for interaction showed that urgent operation in patients undergoing BIMA grafting was associated with higher risk of inhospital death (5.6% versus 1.3%, p = 0.009).Conclusions. Bilateral internal mammary artery grafting in elderly patients seems to be associated with a worse early outcome compared with SIMA grafting, particularly in patients undergoing urgent operation. Until more conclusive results are gathered, BIMA grafting should be reserved only for elderly patients with stable coronary artery disease, without significant baseline comorbidities and with long life expectancy. (C) 2018 by The Society of Thoracic Surgeons

Background: ICDs and pacemakers for cardiac resynchronization therapy (CRT) are complex devices with different sensors and automatic algorithms implanted in patients with advanced cardiac diseases. Data on the perioperative management and outcome of CRT carriers undergoing surgery unrelated to the device are scarce. Methods: Data from 198 CRT device carriers (100 with active rate responsive sensor) were evaluated regarding perioperative adverse (device-related) events (A(D)E) and lead parameter changes. Results: Thirty-nine adverse observations were documented in 180 patients during preoperative interrogation, which were most often related to the left-ventricular lead and requiring intervention/reprogramming in 22 cases (12%). Anesthesia-related events occurred in 69 patients. There was no ADE for non-cardiac surgery and in pacemaker-dependent patients not programmed to an asynchronous pacing mode. Post-operative device interrogation showed significant lead parameter changes in 64/179 patients (36%) requiring reprogramming in 29 cases (16%). Conclusion: The left-ventricular pacing lead represents the most vulnerable system component. Comprehensive pre and post-interventional device interrogation is mandatory to ensure proper system function. The type of ICD function suspension has no impact on each patient’s outcome. Precautionary activity sensor deactivation is not required for non-cardiac interventions. Routine prophylactic device reprogramming to asynchronous pacing appears inessential. Most of the CRT pacemakers do not require surgery-related reprogramming.

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.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).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).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.

OBJECTIVES Minimally invasive surgical techniques with optimal outcomes are of paramount importance. Sutureless and rapid deployment aortic valves are increasingly implanted via minimally invasive approaches. We aimed to analyse the procedural outcomes of a full sternotomy (FS) compared with those of minimally invasive cardiac surgery (MICS) and further assess MICS, namely ministernotomy (MS) and anterior right thoracotomy (ART). METHODS We selected all isolated aortic valve replacements in the Sutureless and Rapid Deployment Aortic Valve Replacement International Registry (SURD-IR, n = 2257) and performed propensity score matching to compare aortic valve replacement through FS or MICS (n = 508/group) as well as through MS and ART accesses (n = 569/group). RESULTS Postoperative mortality was 1.6% in FS and MICS patients who had a mean logistic EuroSCORE of 11%. Cross-clamp and cardiopulmonary bypass (CPB) times were shorter in the FS group than in the MICS group (mean difference 3.2 and 9.2 min; P CONCLUSIONS According to this non-randomized international registry, FS resulted in a higher rate of acute kidney injury. The ART access showed a lower stroke rate than MS and a shorter hospital stay than all other accesses. All these findings may be related to underlying patient risk factors.

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.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.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.LVOT calcification is associated with increased risk of peri-procedural stroke and mortality as well as shorter long-term survival.

BACKGROUND Reoperation for aortic valve replacement can be challenging and is usually associated with an increased risk for complications and mortality. The study aim was to report the results of a multicenter cohort of patients who underwent minimally invasive reoperative aortic valve replacement with a sutureless or rapid-deployment prosthesis. METHODS From 2007 to 2018 data from 3651 patients were retrospectively collected from the Sutureless and Rapid-Deployment Aortic Valve Replacement International Registry. Of them, 63 patients who had previously undergone cardiac surgery represented the study population. In-hospital clinical and echocardiographic outcomes were recorded. RESULTS Mean age of the selected 63 patients was 75.3 ± 7.8 years and logistic EuroSCORE 10.1. Surgery was performed by ministernotomy in 43 patients (68.3%) and by anterior right thoracotomy in 20 (31.7%); 31 patients (49.2%) received the Perceval valve (Livanova PLC, London, UK) and 32 (50.8%) the Intuity valve (Edwards Lifesciences, Irvine, CA). Mean cross-clamp time was 57.8 ± 23.2 minutes and cardiopulmonary bypass time 95.0 ± 34.3 minutes. Neither conversion to full sternotomy nor in-hospital deaths occurred. Postoperative events were ischemic cerebral events in 3 patients (4.8%), need for pacemaker implantation in 2 (3.6%), bleeding requiring reoperation in 5 (8.9%), and dialysis in 1 (1.6%). Median intensive care unit stay was 1 day, and median length of hospital stay was 10 days. On echocardiographic evaluation 1 patient showed a significant postoperative aortic regurgitation. CONCLUSIONS Minimally invasive reoperative aortic valve replacement with a sutureless or rapid-deployment prosthesis is a safe and feasible treatment strategy, resulting in fast recovery and improved postoperative outcome with no mortality and an acceptable complication rate.

Background For patients with coronary artery disease undergoing coronary bypass surgery, acetylsalicylic acid (ASA) currently represents the gold standard of antiplatelet treatment. However, adverse cardiovascular event rates in the first year after coronary artery bypass grafting (CABG) still exceed 10%. Graft failure, which is predominantly mediated by platelet aggregation, has been identified as a major contributing factor in this context. Therefore, intensified platelet inhibition is likely to be beneficial. Ticagrelor, an oral, reversibly binding and direct-acting P2Y 12 receptor antagonist, provides a rapid, competent, and consistent platelet inhibition and has shown beneficial results compared with clopidogrel in the subset of patients undergoing bypass surgery in a large previous trial. Hypothesis Ticagrelor is superior to ASA for the prevention of major cardiovascular events within 1 year after CABG. Study design The TiCAB trial (NCT01755520) is a multicenter, phase III, double-blind, double-dummy, randomized trial comparing ticagrelor with ASA for the prevention of major cardiovascular events within 12 months after CABG. Patients undergoing CABG will be randomized in a 1:1 fashion to either ticagrelor 90 mg twice daily or ASA 100 mg once daily. The study medication will be started within 24 hours after surgery and maintained for 12 months. The primary end point is the composite of cardiovascular death, myocardial infarction, stroke, and repeat revascularization at 12 months after CABG. The sample size is based on an expected event rate of 13% of the primary end point within the first 12 months after randomization in the control group, a 2-sided α level of .0492 (to preserve the overall significance level of .05 after planned interim analysis), a power of 0.80%, 2-sided testing, and an expected relative risk of 0.775 in the active group compared with the control group and a dropout rate of 2%. According to power calculations based on a superiority design for ticagrelor, it is estimated that 3,850 patients should be enrolled. Summary There is clinical equipoise on the issue of optimal platelet inhibition after CABG. The TiCAB trial will provide a pivotal comparison of the efficacy and safety of ticagrelor compared with ASA after CABG.

Objective To define the benefit of sutureless and rapid deployment valves in current minimally invasive approaches in isolated aortic valve replacement. Methods A panel of 28 international experts with expertise in both minimally invasive aortic valve replacement and rapid deployment valves was constituted. After thorough literature review, the experts rated evidence-based recommendations in a modified Delphi approach. Results No guideline could be retrieved. Thirty-three clinical trials and 9 systematic reviews could be identified for detailed text analysis to obtain a total of 24 recommendations. After rating by the experts 12, final recommendations were identified: preoperative computed to-mographic scan as well as intraoperative transesophageal echocardiography are highly recommended. Suitable annular sizes are 19 to 27 mm. There is a contraindication for bicuspid valves only for type 0 and for annular abscess or destruction due to infective endocarditis. The use of sutureless and rapid deployment valves reduces extracorporeal circulation and aortic cross-clamp time and leads to less early complications as prolonged ventilation, blood transfusion, atrial fibrillation, pleural effusions, paravalvular leakages and aortic regurgitation, and renal replacement therapy, respectively. These clinical outcomes result in reduced intensive care unit and hospital stay and reduced costs. The use of sutureless and rapid deployment valves will lead to a higher adoption rate of minimally invasive approaches in aortic valve replacement. Respect should be taken to a necessary short learning curve for both sutureless and minimally invasive programs. Conclusions Sutureless and rapid deployment aortic valve replacement together with minimally invasive approaches offers an attractive option in aortic valve placement for patients requiring biological valve replacement.

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 Nurnberg - 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 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.

OBJECTIVES The ideal strategy for the treatment of severe aortic valve stenosis in patients of varying risk categories has become a debated topic in the last years: should the transcatheter or surgical approach be adopted? The aim of this study was to evaluate the outcomes of low-, intermediate-, high- and very high-risk patients undergoing sutureless, rapid deployment aortic valve replacement. METHODS From 2007 to 2017, data on a total of 3651 patients were collected from the Sutureless and Rapid Deployment Aortic Valve Replacement International Registry (SURD-IR). Of these, 2057 patients who underwent primary isolated aortic valve replacement were considered for this analysis and classified as being at low (EuroSCORE 20; n = 156) preoperative risk. RESULTS Overall, a less invasive approach was used in 74.1% of patients and represented the most frequent (>50%) approach in all risk categories. The Perceval prosthesis was used more frequently than other devices, especially in patients at high and very high risk. Hospital mortality was 1.6%, 0.8%, 1.9% and 2.7% in low-, intermediate-, high- and very high-risk patients, respectively, with no significant differences among subgroups. Similarly, postoperative complication rates were similar across the different risk categories. CONCLUSIONS Surgical aortic valve replacement using sutureless, rapid deployment biological valve prostheses is associated with excellent results and represents a safe and effective treatment option for patients with severe aortic valve stenosis. This seems to be particularly true in patients with a higher risk profile.

Background The Freedom SOLO (FS) stentless bovine-pericardial prosthesis with a supra-annular implantation technique can be a viable option for patients with endocarditic annular destruction. We assessed early- and long-term outcomes following the use of this prosthesis in extensive aortic valve endocarditis. Methods From 2006 to 2016, 59 patients with extensive aortic endocarditis underwent aortic valve replacement (AVR) with FS (cumulative follow-up 263 patients-years) in three European centers; all patients presented annular tissue infection, while 54.3% of patients had annular abscess. Results Mean age was 66 ± 11 years and mean EuroSCORE I was 30.3% (standard deviation: 24.1%). In our series, 30.5% of patients had prosthetic valve endocarditis. Early mortality was 15.2% (nine patients). Estimated overall survival at 5 and 10 years was 68.9% (95% confidence interval [CI]: 62.8–75.0%) and 59.1% (95% CI: 66.8–81.2%), respectively. At 10-year survival, freedom from valve-related death was 83.7% (95% CI: 80.9–86.5%). No structural valve deterioration was reported in this series. Five patients (8.5%) had recurrent endocarditis during follow-up and two of them underwent reoperation. Survival freedom from reoperation and endocarditis at 10-year follow-up was 88.0% (CI: 80.4–95.6%) and 86.7% (CI: 80.5–92.9%), respectively. Conclusion FS stentless bioprosthesis is a valuable and simple option to achieve AVR in patients with extensive aortic annulus endocarditis. Although in this group of complex patients, early mortality remains considerably high, late survival outcomes are comparable to the more technically demanding homografts and conventional stentless bioprostheses, with low rates of endocarditis recurrence.

Objective An aortic annuloplasty ring could be useful for aortic valve repair. This trial evaluated intermediate-term outcomes of internal geometric ring annuloplasty for repair of trileaflet and bicuspid aortic insufficiency associated with ascending aortic and/or aortic root aneurysms. Methods Under regulatory supervision, 47 patients with aortic insufficiency and ascending aortic (n = 22) and/or aortic root (n = 25) aneurysms were managed with aortic valve repair and aneurysm resection. Valve repair was performed using trileaflet (n = 40) or bicuspid (n = 7) internal geometric rings, together with leaflet reconstruction. Ascending aortic and/or remodeling root replacements were accomplished with Dacron grafts 5 to 7 mm larger than the rings. An Echo Core Lab provided independent echocardiographic assessments, and changes over time were evaluated by Friedman tests. Results Mean ± SD age was 60 ± 14 years, 57% (27/47) were male, 15% (7/47) had bicuspid valves, 87% (41/47) had moderate-to-severe aortic insufficiency, and 13% (6/47) had mild aortic insufficiency. All patients had annular dilatation, with a mean ± SD of 26.5 ± 2.6 mm before repair, and mean ± SD ring sizes were 21.7 ± 1.7 mm. Follow-up was 42 months (mean = 27 months). No operative mortality or valve-related complications occurred. Two patients died beyond 1 year from nonvalve-related causes. One patient required valve replacement for repair failure. Survival free of complications or valve replacement was 94% at 2 years. Significant reduction in aortic insufficiency and New York Heart Association class were observed ( P < 0.0001), and valve gradients remained low. No heart block or direct ring complications occurred. Conclusions In preliminary regulatory studies, aortic ring annuloplasty seemed safe and effective during aortic aneurysm surgery. This approach could help standardize aortic valve repair.

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

Aims No data exists on inter-institutional differences in terms of adherence to international guidelines regarding the discontinuation of antithrombotics and rates of severe bleeding in coronary artery bypass grafting (CABG). Methods and results This is an analysis of 7118 patients from the prospective multicentre European CABG (E-CABG) registry who underwent isolated CABG in 15 European centres. Preoperative pause of P2Y12 receptor antagonists shorter than that suggested by the 2017 ESC guidelines (overall 11.6%) ranged from 0.7% to 24.8% between centres (adjusted P < 0.0001) and increased the rate of severe-massive bleeding [E-CABG bleeding grades 2-3, OR 1.66, 95% confidence interval (CI) 1.27-2.17; Universal Definition of Perioperative Bleeding (UDPB) bleeding grades 3-4, OR 1.50, 95% CI 1.16-1.93]. The incidence of resternotomy for bleeding (overall 2.6%) ranged from 0% to 6.9% (adjusted P < 0.0001), and surgical site bleeding (overall 59.6%) ranged from 0% to 84.6% (adjusted P = 0.003). The rate of the UDPB bleeding grades 3-4 (overall 8.4%) ranged from 3.7% to 22.3% (P < 0.0001), and of the E-CABG bleeding grades 2-3 (overall 6.5%) ranged from 0.4% to 16.4% between centres (P < 0.0001). Resternotomy for bleeding (adjusted OR 5.04, 95% CI 2.85-8.92), UDPB bleeding grades 3-4 (adjusted OR 6.61, 95% CI 4.42-9.88), and E-CABG bleeding grades 2-3 (adjusted OR 8.71, 95% CI 5.76-13.15) were associated with an increased risk of hospital/30-day mortality. Conclusions Adherence to the current guidelines on the early discontinuation of P2Y12 receptor antagonists is of utmost importance to reduce excessive bleeding and early mortality after CABG. Inter-institutional variation should be considered for a correct interpretation of the results in multicentre studies evaluating perioperative bleeding and use of blood products.

OBJECTIVES: Several single-centre experiences have reported significant operative mortality and morbidity after mitral valve surgery in redo scenarios (ReMVS). Several preoperative risk factors outlining 'high-risk' categories have been reported, but scanty data on the impact of different operative techniques for these major challenging procedures have been analysed to date. The aim of the study is to investigate those intraoperative factors and postoperative events affecting early survival after redo mitral procedures.METHODS: Operative mortality and major morbidity events from a large multicentre registry enrolling 832 consecutive redo mitral procedures were analysed. Intraoperative technical issues and postoperative complications impacting operative mortality were identified.RESULTS: ReMVS was associated with significant operative mortality (12.5%), acute myocardial infarction (AMI; 5.9%), stroke (4.9%), acute respiratory insufficiency (14.8%), pneumonia (7.0%), acute renal insufficiency (16.1%) and failure (12.6%), reintervention for bleeding (7.6%), massive transfusion (28.0%), need for permanent pacemaker (10.1%). Injury of a previous patent left internal mammary artery (LIMA) graft [odds ratio (OR) 4.2, 95% confidence interval (CI): 1.6-11.5; P = 0.005], major cardiovascular iatrogenic lesions at re-entry (OR 19.2, 95% CI: 9.2-39.9; P < 0.001), extracellular crystalloid cardioplegia (OR 7.3, 95% CI: 1.4-37.8; P = 0.018), and incremental cardiopulmonary bypass time (OR 1.1, 95% CI: 1.0-1.2; P = 0.001) independently predicted operative mortality, whereas combined antegrade + retrograde cardioplegia (OR 0.2, 95% CI: 0.09-0.4; P = 0.001) was the only protective factor against mortality. Among complications, AMI (OR 4.1, 95% CI: 1.8-9.6; P = 0.001), need for intra-aortic balloon pumping (IABP; OR 3.1, 95% CI: 1.5-6.1; P = 0.001), prolonged intubation >48 h (OR 5.3, 95% CI: 2.9-9.4; P = 0.001) and massive (>6 units) transfusions (OR 4.4, 95% CI: 2.4-8.0; P = 0.001) also predicted operative mortality.CONCLUSIONS: ReMVS still carries the risk of significant early mortality and major morbidity. Major lesion to cardiovascular structures is the most dreadful iatrogenic complication, and injury of a previous LIMA graft identifies patients at higher risk of operative mortality. Prolonged cross-clamp times, extracellular crystalloid cardioplegia and massive transfusions have profound impact on early outcome, as well as the development of perioperative AMI, eventually requiring IABP and prolonged intubation. The combination of antegrade and retrograde cardioplegia seems to offer a better myocardial protection in these high-risk patients.

Prone positioning is a therapeutic maneuver to improve arterial oxygenation in patients with acute lung injury that is not implemented in most centers performing adult cardiac surgery. The aim of this study was to review our experience with prone positioning to assess the effects of this maneuver in patients with postoperative acute respiratory failure. From 2010-2014, 127 adult patients with postoperative acute respiratory failure were treated with prone positioning in addition to specific therapy. Univariate and multivariate logistic regression analyses were performed to identify independent risk factors associated with in-hospital mortality. In-hospital mortality was 22.8% (n = 29). No significant differences were observed in preoperative risk factors between patients who survived (S) and those who died (D), except for age (62.7 ± 11.2 vs 70.2 ± 11.3; P = 0.007-at multivariate analysis P = 0.03, odds ratio [OR] = 1.1/year). Preproning values of PaO2/FiO2 were significantly different between groups (D vs S: 115 ± 46 vs 150 ± 56; P = 0.006), but only preproning FiO2 remained highly significant at multivariate analysis (D vs S: 0.82 ± 0.18 vs 0.67 ± 0.16; P = 0.001, OR = 1.07; with FiO2 > 0.75 vs < 75, OR = 19.6). D showed a higher improvement of PaO2/FiO2 immediately after prone positioning (207 ± 100 vs 219 ± 90, P = 0.56; within-group analysis between preproning and 1 hour after proning: S-P = 0.49, D-P = 0.019; at 12 hours: 286 ± 123 vs 240 ± 120, P = 0.06; within-group analysis between 1 hour and 12 hours after proning: S-P = 0.15; D-P = 0.17; between groups-P = 0.05). D had higher peak WBC count (26 ± 9.8 vs 17.7 ± 5.9×103/mL; P = 0.0001) and a higher rate of low output syndrome (15 vs 9 patients-51.7% vs 9.2%; P = 0.0001). At multivariate analysis, white blood cell count: P = 0.005, OR = 1.11/103 white blood cell; low output syndrome: P = 0.0002, OR = 20.5. In conclusion, our results show that prone positioning, if performed early, is a safe and effective adjunct measure for patients with postoperative acute hypoxemic respiratory failure of noncardiogenic origin.