A streamlined pathway for transcatheter aortic valve implantation: the BENCHMARK study.

BACKGROUND AND AIMS: There is significant potential to streamline the clinical pathway for patients undergoing transcatheter aortic valve implantation (TAVI). The purpose of this study was to evaluate the effect of implementing BENCHMARK best practices on the efficiency and safety of TAVI in 28 sites in 7 European countries. METHODS: This was a study of patients with severe symptomatic aortic stenosis (AS) undergoing TAVI with balloon-expandable valves before and after implementation of BENCHMARK best practices. Principal objectives were to reduce hospital length of stay (LoS) and duration of intensive care stay. Secondary objective was to document patient safety. RESULTS: Between January 2020 and March 2023, 897 patients were documented prior to and 1491 patients after the implementation of BENCHMARK practices. Patient characteristics were consistent with a known older TAVI population and only minor differences. Mean LoS was reduced from 7.7 ± 7.0 to 5.8 ± 5.6 days (median 6 vs. 4 days; P < .001). Duration of intensive care was reduced from 1.8 to 1.3 days (median 1.1 vs. 0.9 days; P < .001). Adoption of peri-procedure best practices led to increased use of local anaesthesia (96.1% vs. 84.3%; P < .001) and decreased procedure (median 47 vs. 60 min; P < .001) and intervention times (85 vs. 95 min; P < .001). Thirty-day patient safety did not appear to be compromised with no differences in all-cause mortality (0.6% in both groups combined), stroke/transient ischaemic attack (1.4%), life-threatening bleeding (1.3%), stage 2/3 acute kidney injury (0.7%), and valve-related readmission (1.2%). CONCLUSIONS: Broad implementation of BENCHMARK practices contributes to improving efficiency of TAVI pathway reducing LoS and costs without compromising patient safety.

A New Apheresis Device for Antithrombotic Drug Removal during Off-Pump Coronary Artery Bypass Surgery.

Background and Objectives: The hemoadsorption device CytoSorb® (CytoSorbents Inc., Princeton, NJ, USA) has been shown to efficiently remove ticagrelor from whole blood in vitro. A promising clinical experience was made with the integration of the hemoadsorption cartridge on the cardiopulmonary bypass (CPB) circuit during cardiac surgery to reduce adverse events. Materials and Methods: In this report, we describe a novel approach using a new apheresis platform, PUR-01 (Nikkisio Co., Ltd., Tokyo, Japan), which was used as the extracorporeal circuit where CytoSorb® could be installed for the removal of ticagrelor during off-pump coronary artery bypass (OPCAB) procedures. Results: In a 74-year-old male (index case) with coronary artery disease and dual antiplatelet therapy, hemoadsorption was initiated with a skin incision for OPCAB surgery and was continued for 221 min to eliminate ticagrelor. The blood volume that had circulated through the CytoSorb® was 39.04 L in total. Thus far, this treatment strategy has been used in four cases with CHD and DAPT who needed OPCAB surgery. The intraoperative and postoperative courses were uneventful in all patients. No device-related adverse events occurred. Conclusions: The combination of the PUR-01 apheresis pump and hemoadsorption with the CytoSorb® column during OPCAB procedures appears to be safe and effective in eliminating antiplatelet drugs.

Two approaches-one phenomenon-thrombocytopenia after surgical and transcatheter aortic valve replacement.

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

Risk factors for atrioventricular block after transcatheter aortic valve implantation: a single-centre analysis including assessment of aortic calcifications and follow-up.

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

Healthcare IT Utilization and Penetration among Physicians: Novel IT Solutions in Healthcare - Use and Acceptance in Hospitals.

BACKGROUND: Healthcare IT (HIT) increasingly gains public attention and clinical daily relevance. A growing number of patients and physicians increasingly relies on IT services to monitor and support well-being and recovery both in their private and professional environment. This is assumed to develop rapidly in the upcoming years. OBJECTIVE: This study examines the current status of HIT, its use and penetration among physicians in hospitals and researches utilization as well as future expectations regarding HIT. METHODS: Physicians in Germany, Austria and Switzerland were addressed via e-mail to answer a standardized Internet-based questionnaire consisting of 17 multiple-choice and 3 open text questions. Parameters were evaluated in 5 categories: general use, frequency, acceptance, IT needs and future expectations. RESULTS: An overall 234 physicians (response rate 83.6%) with a median age of 45 (range 25-60) responded and filled out the entire online questionnaire. A significant correlation between parameters gender, age and level of training (resident, specialist, consultant etc.) was proven. The professional, medical employment of technology shows a strong correlation with age as well as level of training. Whereas increasing age among physicians is associated with a decreasing level of application of HIT, a higher training level is accompanied by an increasing level of professional application of IT services and tools within the healthcare context. Routine employment of HIT is regarded as a necessary and positive standard. Most users assume the importance of HIT to strongly grow in the future in comparison to current use. A clear lack of trust towards data security and storage is recognized on both patient and physician sides. Needs are currently satisfied by employing privately acquired IT in the professional setup rather than the hospitals'. Future expectations from HIT show a clear demand for interoperability and exchangeability of data. CONCLUSIONS: The results display a clear gap between demand and expectations of IT for medical purposes. The rate of use of HIT applications generally correlates with age, gender as well as role within the hospital and type of employment within the healthcare sector. The current offering does not satisfy the needs of healthcare professionals.

Sutureless versus Transfemoral Transcatheter Aortic Valve Implant: A Propensity Score Matching Study.

BACKGROUND AND AIM OF THE STUDY: Transcatheter aortic valve implantation (TAVI), especially via the transfemoral (TF) route, is increasingly performed in patients considered in the 'gray zone' between TAVI and surgery. However, the best treatment option in this patient population remains to be established. METHODS: Since 2010, a total of 923 patients underwent either TAVI (n = 538) or sutureless aortic valve replacement (AVR) (n = 385) at the authors' institutions. Among these patients, 79 treated with TF-TAVI were compared with 79 propensity score-matched patients who had undergone elective isolated AVR with the sutureless Perceval bioprosthesis. RESULTS: In-hospital mortality did not differ significantly between patients who underwent sutureless AVR or TF-TAVI (none versus three; 3.8%; p = 0.123). Similarly, postoperative complications were comparable between groups. Atrioventricular block requiring postoperative pacemaker implantation occurred in seven patients (9.2%) of the sutureless group and in eight patients (11.1%) of the TF-TAVI group (p = 0.455). The use of blood products varied between groups in terms of red blood cell transfusions (1.7 ± 2 versus 0.3 ± 0.9 units for the sutureless group versus TF-TAVI group; p <0.001). Paravalvular leakage at discharge was present in three patients (3.8%) in the sutureless group and in 26 patients (32.9%) in the TF-TAVI group (p <0.001). The mean follow up was longer for sutureless AVR (36 ± 21 versus 27 ± 20 months; p = 0.003). Survival rates were 97.5% and 84.8% in the sutureless and TF-TAVI groups, respectively (p = 0.001). CONCLUSIONS: Both, TF-TAVI and sutureless AVR are well-standardized, safe and effective procedures. TF-TAVI seems to be a valuable alternative to surgical AVR for frail patients, reducing the need for perioperative blood transfusion. In contrast, in patients with a favorable long-term survival outcome, minimally invasive AVR remains the procedure of choice as it is associated with better long-term results.

Sutureless Valve Implantation via Mini J-Sternotomy: A Single Center Experience with 2 Years Mean Follow-up.

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

Improved early risk stratification of deep sternal wound infection risk after coronary artery bypass grafting.

BACKGROUND: Deep sternal wound infection (DSWI) following open heart surgery is associated with excessive morbidity and mortality. Contemporary DSWI risk prediction models aim at identifying high-risk patients with varying complexity and performance characteristics. We aimed to optimize the DSWI risk factor set and to identify additional risk factors for early postoperative detection of patients prone to DSWI. METHODS: Single-centre retrospective analysis of patients with isolated multivessel coronary artery disease undergoing myocardial revascularization at Paracelsus Medical University Nuremberg between 2007 and 2022 was performed to identify risk factors for DSWI. Three data sets were created to examine preoperative, intraoperative, and early postoperative parameters, constituting the "Baseline", the "Improved Baseline" and the "Extended" models. The "Extended" data set included risk factors that had not been analysed before. Univariable and stepwise forward multiple logistic regression analyses were performed for each respective set of variables. RESULTS: From 5221 patients, 179 (3.4%) developed DSWI. The "Extended" model performed best, with the area under the curve (AUC) of 0.80, 95%-CI: [0.76, 0.83]. Pleural effusion requiring intervention, postoperative delirium, preoperative hospital stay > 24 h, and the use of fibrin sealant were new independent predictors of DSWI in addition to age, Diabetes Mellitus on insulin, Body Mass Index, peripheral artery disease, mediastinal re-exploration, bilateral internal mammary harvesting, acute kidney injury and blood transfusions. CONCLUSIONS: The "Extended" regression model with the short-term postoperative complications significantly improved DSWI risk discrimination after surgical revascularization. Short preoperative stay, prevention of postoperative delirium, protocols reducing the need for evacuation of effusion and restrictive use of fibrin sealant for sternal closure facilitate DSWI reduction. TRIAL REGISTRATION: The registered retrospective study was registered at the study centre and approved by the Institutional Review Board of Paracelsus Medical University Nuremberg (IRB-2019-005).

Antithrombotic drug removal with hemoadsorption during off-pump coronary artery bypass grafting.

BACKGROUND: Patients requiring coronary artery bypass grafting (CABG) are often loaded with antithrombotic drugs (AT) and are at an increased risk for perioperative bleeding complications. Active AT removal by a hemoadsorption cartridge integrated in the cardiopulmonary bypass circuit is increasingly used in this setting to reduce bleeding, and herein we describe the extension of this application in patients on AT undergoing off-pump coronary artery bypass (OPCAB). METHODS: Ten patients (80% male; mean age: 67.4 ± 9.2years) were treated with ticagrelor (eight patients), rivaroxaban and ticagrelor (one patient), and rivaroxaban (one patient) prior to OPCAB surgery. AT's were discontinued one day before surgery in nine patients and on the day of surgery in one patient, and all patients were also on aspirin. The cohort mean EuroSCORE-II was 2.9 ± 1.5%. A hemoadsorption cartridge was integrated into a dialysis device (n=4) or a stand-alone apheresis pump (n=6) periprocedural, for a treatment time of 145 ± 33 min. Outcome measures included bleeding according to Bleeding Academic Research Consortium (BARC)-4 and 24-hour chest-tube-drainage (CTD). RESULTS: Mean operation time was 184 ± 35 min. All patients received a left internal thoracic artery with a mean of 2.3 ± 0.9 total grafts. One patient had a BARC-4 bleeding event and there were no surgical re-explorations for bleeding. Mean 24-hours CTD was 680 ± 307mL. During follow-up of 19.5 ± 17.0 months, none of the patients died or required further reinterventions. No device-related adverse events were reported. CONCLUSIONS: Hemoadsorption via a stand-alone apheresis pump during OPCAB surgery was feasible and safe. This innovative and new approach showed favorable bleeding rates in patients on antithrombotic drugs requiring bypass surgery.

Advanced age per se should not be an exclusion criterion for minimally invasive aortic valve replacement.

BACKGROUND AND AIM OF THE STUDY: The introduction of transcatheter aortic valve implantation (TAVI), coupled with the increasing number of elderly patients requiring cardiac surgery, has given rise to an intense debate on the most appropriate treatment strategy for this high-risk population. The study aim was to compare clinical outcomes in older versus younger patients undergoing minimally invasive aortic valve replacement (AVR). METHODS: Between March 2010 and July 2012, 66 patients undergoing minimally invasive isolated AVR with the sutureless Perceval S bioprosthesis (Sorin Group, Saluggia, Italy) were allocated to two groups according to age > or = 80 years (group A, n = 25) or < 80 years (group B, n = 41). In-hospital and follow up data were collected for all patients, including an evaluation of the patients' quality of life, using the SF-36 questionnaire. RESULTS: Mean age and logistic EuroSCORE were statistically different between groups (p < 0.001 and p = 0.002, respectively). The length of intensive care unit stay was similar in groups A and B (1.9 +/- 0.8 and 2.5 +/- 1.4 days, respectively; p = 0.061). In-hospital mortality occurred in only one patient of group A (1.5%). Postoperative transient cerebral ischemic events occurred with similar frequency in both groups (two in group A and four in group B; p = 0.59). One patient in group A and two patients in group B required pacemaker implantation (1.5 versus 3%; p = 0.68). The mean follow up was 13.9 +/- 7.4 months, during which time three patients died (two in group A, one in group B). All enrolled patients answered the SF-36 questionnaire, and there were no significant differences between groups in all eight domains of the test. CONCLUSION: Within the setting of minimally invasive isolated AVR, the study results showed that the clinical outcomes and quality of life in patients aged > or = 80 years were comparable to those of younger patients. Therefore, advanced age per se does not preclude successful AVR through a minimally invasive approach.

Ten years' experience with the sutureless aortic valve replacement: incidence and predictors for survival and valve durability at follow-up.

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 < 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 1 year and for EuroSCORE II is 1 percentage point. Structural valve deterioration (SVD) was observed in 23 patients, of whom 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. 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.

A Machine Learning Model for the Accurate Prediction of 1-Year Survival in TAVI Patients: A Retrospective Observational Cohort Study.

BACKGROUND: predicting the 1-year survival of patients undergoing transcatheter aortic valve implantation (TAVI) is indispensable for managing safe early discharge strategies and resource optimization. METHODS: Routinely acquired data (134 variables) were used from 629 patients, who underwent transfemoral TAVI from 2012 up to 2018. Support vector machines, neuronal networks, random forests, nearest neighbour and Bayes models were used with new, previously unseen patients to predict 1-year mortality in TAVI patients. A genetic variable selection algorithm identified a set of predictor variables with high predictive power. RESULTS: Univariate analyses revealed 19 variables (clinical, laboratory, echocardiographic, computed tomographic and ECG) that significantly influence 1-year survival. Before applying the reject option, the model performances in terms of negative predictive value (NPV) and positive predictive value (PPV) were similar between all models. After applying the reject option, the random forest model identified a subcohort showing a negative predictive value of 96% (positive predictive value = 92%, accuracy = 96%). CONCLUSIONS: Our model can predict the 1-year survival with very high negative and sufficiently high positive predictive value, with very high accuracy. The "reject option" allows a high performance and harmonic integration of machine learning in the clinical decision process.

Risk of conduction disturbances following different transcatheter aortic valve prostheses: the role of aortic valve calcifications.

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

Artificial intelligence-based early detection of acute kidney injury after cardiac surgery.

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.

Single-Centre Retrospective Evaluation of Intraoperative Hemoadsorption in Left-Sided Acute Infective Endocarditis.

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.

Left Atrial Appendage Amputation for Atrial Fibrillation during Aortic Valve Replacement.

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.

Surgical aortic valve replacement in patients aged 50-69 years-insights from the German Aortic Valve Registry (GARY).

OBJECTIVES: The aim of this study was to analyse the outcome of patients between 50 and 69 years of age undergoing biological or mechanical aortic valve replacement. METHODS: Data were collected from the German Aortic Valve Registry. Data were analysed regarding baseline characteristics and outcome parameters such as 5-year survival, stroke and reintervention. RESULTS: In total.3046 patients undergoing isolated surgical aortic valve replacement between 2011 and 2012 were investigated and a propensity score matching was performed. Within this period, 2239 patients received a biological prostheses, while 807 patients received a mechanical prosthesis. Mean age in the biological group was 63.07 (±5.11) and 57.34 (±4.67) in the mechanical group (standardized mean difference 1.172). In the overall cohort, there were more female patients in the biological group (32.7% vs 28.4%) and log EuroSCORE I was higher (5.41% vs 4.26%). After propensity matching (610 pairs), there was no difference in the mortality at 5-year follow-up (12.1% biological vs 9.2% mechanical P = 0.05) nor for reoperation/reintervention (2.5% biological vs 2.0% mechanical, P = 0.546). Patients undergoing mechanical aortic valve replacement suffered from a higher stroke rate 3.3% vs 1.5% (P = 0.04) at 5-year follow-up. CONCLUSIONS: Aortic valve replacement with biological or mechanical prostheses showed similar 5-year outcomes for survival and reoperation in a propensity-matched cohort, but significantly increased stroke rate after mechanical aortic valve replacement. This could influence the choice of a mechanical valve in younger patients.

Hemodynamic Performance of Sutureless vs. Conventional Bioprostheses for Aortic Valve Replacement: The 1-Year Core-Lab Results of the Randomized PERSIST-AVR Trial.

OBJECTIVE: Sutureless aortic valves are an effective option for aortic valve replacement (AVR) showing non-inferiority to standard stented aortic valves for major cardiovascular and cerebral events at 1-year. We report the 1-year hemodynamic performance of the sutureless prostheses compared with standard aortic valves, assessed by a dedicated echocardiographic core lab. METHODS: Perceval Sutureless Implant vs. Standard Aortic Valve Replacement (PERSIST-AVR) is a prospective, randomized, adaptive, open-label trial. Patients undergoing AVR, as an isolated or combined procedure, were randomized to receive a sutureless [sutureless aortic valve replacement (Su-AVR)] (n = 407) or a stented sutured [surgical AVR (SAVR)] (n = 412) bioprostheses. Site-reported echocardiographic examinations were collected at 1 year. In addition, a subgroup of the trial population (Su-AVR n = 71, SAVR = 82) had a complete echocardiographic examination independently assessed by a Core Lab (MedStar Health Research Institute, Washington D.C., USA) for the evaluation of the hemodynamic performance. RESULTS: The site-reported hemodynamic data of stented valves and sutureless valves are stable and comparable during follow-up, showing stable reduction of mean and peak pressure gradients through one-year follow-up (mean: 12.1 ± 6.2 vs. 11.5 ± 4.6 mmHg; peak: 21.3 ± 11.4 vs. 22.0 ± 8.9 mmHg). These results at 1-year are confirmed in the subgroup by the core-lab assessed echocardiogram with an average mean and peak gradient of 12.8 ± 5.7 and 21.5 ± 9.1 mmHg for Su-AVR, and 13.4 ± 7.7 and 23.0 ± 13.0 mmHg for SAVR. The valve effective orifice area was 1.3 ± 0.4 and 1.4 ± 0.4 cm2 at 1-year for Su-AVR and SAVR. These improvements are observed across all valve sizes. At 1-year evaluation, 91.3% (n = 42) of patients in Su-AVR and 82.3% in SAVR (n = 51) groups were free from paravalvular leak (PVL). The rate of mild PVL was 4.3% (n = 2) in Su-AVR and 12.9% (n = 8) in the SAVR group. A similar trend is observed for central leak occurrence in both core-lab assessed echo groups. CONCLUSION: At 1-year of follow-up of a PERSIST-AVR patient sub-group, the study showed comparable hemodynamic performance in the sutureless and the stented-valve groups, confirmed by independent echo core lab. Perceval sutureless prosthesis provides optimal sealing at the annulus with equivalent PVL and central regurgitation extent rates compared to sutured valves. Sutureless valves are therefore a reliable and essential technology within the modern therapeutic possibilities to treat aortic valve disease.

The Technological Basis of a Balloon-Expandable TAVR System: Non-occlusive Deployment, Anchorage in the Absence of Calcification and Polymer Leaflets.

Leaflet durability and costs restrict contemporary trans-catheter aortic valve replacement (TAVR) largely to elderly patients in affluent countries. TAVR that are easily deployable, avoid secondary procedures and are also suitable for younger patients and non-calcific aortic regurgitation (AR) would significantly expand their global reach. Recognizing the reduced need for post-implantation pacemakers in balloon-expandable (BE) TAVR and the recent advances with potentially superior leaflet materials, a trans-catheter BE-system was developed that allows tactile, non-occlusive deployment without rapid pacing, direct attachment of both bioprosthetic and polymer leaflets onto a shape-stabilized scallop and anchorage achieved by plastic deformation even in the absence of calcification. Three sizes were developed from nickel-cobalt-chromium MP35N alloy tubes: Small/23 mm, Medium/26 mm and Large/29 mm. Crimp-diameters of valves with both bioprosthetic (sandwich-crosslinked decellularized pericardium) and polymer leaflets (triblock polyurethane combining siloxane and carbonate segments) match those of modern clinically used BE TAVR. Balloon expansion favors the wing-structures of the stent thereby creating supra-annular anchors whose diameter exceeds the outer diameter at the waist level by a quarter. In the pulse duplicator, polymer and bioprosthetic TAVR showed equivalent fluid dynamics with excellent EOA, pressure gradients and regurgitation volumes. Post-deployment fatigue resistance surpassed ISO requirements. The radial force of the helical deployment balloon at different filling pressures resulted in a fully developed anchorage profile of the valves from two thirds of their maximum deployment diameter onwards. By combining a unique balloon-expandable TAVR system that also caters for non-calcific AR with polymer leaflets, a powerful, potentially disruptive technology for heart valve disease has been incorporated into a TAVR that addresses global needs. While fulfilling key prerequisites for expanding the scope of TAVR to the vast number of patients of low- to middle income countries living with rheumatic heart disease the system may eventually also bring hope to patients of high-income countries presently excluded from TAVR for being too young.