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

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

Background We aimed to evaluate the impact of membranous interventricular septum (MIS) length and calcifications of the native aortic valve (AV), via preoperative multidetector computed tomography (MDCT) scan, on postoperative atrioventricular block III (AVB/AVB III) and permanent pacemaker implantation in surgical aortic valve replacement (SAVR). Methods We retrospectively analyzed preoperative contrast-enhanced MDCT scans and procedural outcomes of patients affected by AV stenosis who underwent SAVR at our center (June 2016–December 2019). The study population was divided into two groups (AVB and non-AVB), and variables were compared with a Mann–Whitney's U-test or chi-square test. Data were further analyzed using point biserial correlation and logistic regression. Results A total of 155 (38% female) patients (mean age of 71.2 ± 6 years) were enrolled in our study: conventional stented bioprosthesis (N = 99) and sutureless prosthesis (N = 56) were implanted. A postoperative AVB III was observed in 11 patients (7.1%). AVB patients had significant greater calcifications in left coronary cusp (LCC) -AV (non-AVB = 181.0 mm3 [82.7–316.9] vs. AVB = 424.8 mm3 [115.9–563.2], p = 0.044), LCC left ventricular outflow tract (LVOT) (non-AVB = 2.1 mm3 [0–20.1] vs. AVB = 26.0 mm3 [0.1–138.0], p = 0.048), right coronary cusp (RCC) -LVOT (non-AVB = 0 mm3 [0–3.5] vs. AVB = 2.8 mm3 [0–29.0], p = 0.039), and consequently in total LVOT (non-AVB = 2.1 mm3 [0–20.1] vs. AVB = 26.0 mm3 [0.1–138.0], p = 0.02), while their MIS was significantly shorter than in non-AVB patients (non-AVB = 11.3 mm [9.9–13.4] vs. AVB = 9.44 mm [6.98–10.5]; p=0.014)). Partially, these group differences correlated positively (LCC -AV, r = 0.201, p = 0.012; RCC -LVOT, r = 0.283, p ≤ 0.001) or negatively (MIS length, r = −0.202, p = 0.008) with new-onset AVB III. Conclusion We recommend including an MDCT in preoperative diagnostic testing for all patients undergoing surgical AVR for further risk stratification.

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

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

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

Objectives The aim of this study was to investigate the need for postoperative permanent pacemaker implantation (PPI) following sutureless and rapid-deployment aortic valve replacement (SuRD-AVR) in the context of a progress report from a large multicenter international registry (SURD-IR). Methods We retrospectively analyzed 4,166 patients who underwent SuRD-AVR between 2008 and 2019. The primary outcome was the need for PPI before discharge. The study population was analyzed separately according to the implanted prostheses (Su cohort and RD cohort). Each cohort was divided into two groups based on the operation date: an early group (“EG” = 2008–2016) and a late group (“LG” = 2017–2019). Results The rate of PPI decreased significantly in the Su cohort over time (EG = 10.8% vs LG = 6.3%, p Conclusions Our analysis showed a significant decrease in the PPI rate in patients who underwent Su-AVR over time. Patient selection as well as surgical improvements and a more accurate sizing could be correlated with this phenomenon. The RD cohort revealed no significant differences either in patient's characteristics or in PPI rate between the two time periods.

In der letzten Dekade hat sich die Behandlung der Aortenklappenstenose tiefgreifend verandert. Neben der Transkatheter-Aortenklappenimplantation (TAVI) haben sich auch chirurgische minimal-invasive Operationstechniken in Kombination mit „schnell implantierbaren“ Prothesen (sutureless and rapid deployment, „SuRD“) durchgesetzt. Viele Studien zum Einsatz der SuRD-Prothesen wurden bisher veroffentlicht. Daruber hinaus wurde ein neues Modell eingefuhrt. In diesem Beitrag werden der Stand der Technik in Bezug auf die bisher gesammelten Erfahrungen und die Indikationen fur diese Prothesen erortert sowie mogliche Zukunftsaussichten diskutiert.

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

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.

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.

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.

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

ObjectiveSutureless 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.MethodsPerceval 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.ResultsThe 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.ConclusionAt 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.

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.

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

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.

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.

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.

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

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

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

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.

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.

Background: Sutureless and rapid-deployment aortic valve replacement (SURD-AVR) has become a prominent area of research as the medical community evaluate its place amongst other aortic valve interventions. The main advantages of SURD-AVR established to date are the reduced cross-clamp and cardiopulmonary bypass (CPB) times, as well as facilitating minimally invasive surgery in high-risk surgical patients. This current systematic review and meta-analysis, to our knowledge, is the first focusing on long-term outcomes regarding safety, efficacy and durability of SURD-AVR from available current literature. Methods: A literature search via six electronic databases was performed from their inception to November 2019. Inclusion criteria for this systematic review included survival and postoperative echocardiographic outcomes greater than five years in patients who underwent SURD-AVR with either Perceval or Intuity valves. Studies were identified and data extracted by two independent reviewers. Long-term survival outcomes were aggregated using digitized Kaplan-Meier curves where available. Results: After applying predefined inclusion and exclusion criteria, four studies were identified for review. All four studies were observational and in total reported data for 1,998 patients. Almost half (42.4%) of patients underwent SURD-AVR via full sternotomy, with almost one third (30.1%) also undergoing concomitant cardiac procedures. Aggregate overall survival rates at 1-, 2-, 3-, and 5-year follow-up were 94.9%, 91.2%, 89.0%, and 84.2%, respectively. Incidence of strokes (4.8%), severe paravalvular leaks (PVLs) (1.5%) and permanent pacemaker (PPM) insertion (8.2%) at up to 5-year follow-up were acceptable. At 5-year follow-up hemodynamic outcomes were also acceptable for mean pressure gradient (MPG) (range, 8.8–13.6 mmHg), peak pressure gradient (PPG) (range, 18.9–21.1 mmHg) and effective orifice area (EOA) (range, 1.5–1.8 cm 2 ). Conclusions: Evaluation of the evidence reporting long-term outcomes of SURD-AVR suggests that it is a safe procedure for AVR with low rates of complications. Long-term outcomes presented in this review show that not only does SURD-AVR have acceptable survival rates, but also good hemodynamic performance at 5-year follow-up.

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.

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