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Background: In patients with coronary artery disease and concomitant asymptomatic severe carotid stenosis, combined simultaneous coronary artery bypass grafting (CABG) and carotid endarterectomy (CEA) has been widely performed despite lack of evidence from randomized trials. We recently showed that the risk of stroke or death within 30 days was higher following CABG+CEA compared with CABG alone. Here, we report long-term outcomes following CABG with versus without CEA. Methods: The CABACS (Coronary Artery Bypass Graft Surgery in Patients With Asymptomatic Carotid Stenosis Study) is a randomized, controlled, multicenter, open trial. Patients with asymptomatic severe (≥70%) carotid stenosis undergoing CABG were allocated either CABG+CEA or CABG alone, and follow-up was 5 years. Major secondary end points included nonfatal stroke or death, any death and any nonfatal stroke. Due to low recruitment, the study was stopped prematurely after randomization of 127 patients in 17 centers. Results: By 5 years, the rate of stroke or death did not significantly differ between groups (CABG+CEA 40.6% [95% CI, 0.285–0.536], CABG alone 35.0% [95% CI, 0.231–0.484]; P =0.58). Higher albeit statistically nonsignificant rates of nonfatal strokes occurred at any time following CABG+CEA versus CABG alone (1 year: 19.3% versus 7.1%, P =0.09; 5 years: 29.4% versus 18.8%, P =0.25). All-cause mortality up to 5 years was similar in both groups (CABG+CEA: 25.4% versus CABG alone: 23.3%, hazard ratio, 1.148 [95% CI, 0.560–2.353]; P =0.71). Subgroup analyses did not reveal any significant effect of age, sex, preoperative modified Rankin Scale and center on outcome events. Conclusions: During 5-years follow-up, combined simultaneous CABG+CEA was associated with a higher albeit statistically nonsignificant rate of stroke or death compared with CABG alone. This was mainly due to a nonsignificantly higher perioperative risk following CABG+CEA. Since the power of our study was not sufficient, no significant effect of either procedure could be observed at any time during follow-up. Registration: URL: http://www.controlled-trials.com ; Unique identifier: ISRCTN13486906.

OBJECTIVES We evaluate the mid-term results of mitral valve (MV) repair with patch augmentation of the posterior leaflet in secondary mitral regurgitation. METHODS Patients were included after diagnosis of a severe symptomatic secondary MV insufficiency with grade III and IV according to the Carpentier classification IIIb. Indication for a patch augmentation technique was a dilatation of the left ventricle leading to a displacement of the papillary muscles, causing restricted leaflet motion and a marked leaflet tenting height. Data were collected prospectively between December 2011 and March 2020. RESULTS In total, 174 patients (mean age: 65 ± 12 years) received an MV repair with patch augmentation of the posterior leaflet and a true-sized remodelling annuloplasty (mean size 30.8 mm). Causes of the MV incompetence were dilatative cardiomyopathy in 126 patients and ischaemic myocardial disease in 48 patients. Concomitant bypass surgery was performed in 28 patients, and the tricuspid valve was repaired in 68 patients. The mean follow-up was 40 ± 28.2 months. There was no 30-day mortality. In-hospital mortality was 1.2% (n = 2); late mortality was 10.9% (n = 19). At 8 years, overall survival was 62.48%, freedom from moderate or severe recurrent mitral regurgitation was 91.9% and freedom from reoperation due to MV insufficiency was 97.1%. CONCLUSIONS Augmentation of the posterior MV leaflet in addition to remodelling annuloplasty is a safe and reproducible mitral reconstruction technique that renders sustainable MV competence.

OBJECTIVES The study objective was to describe the technique and outcomes of original coronary ostial slide plasty in patients with anomalous coronary artery origin (ACAO) localized in the aneurysmal ascending aorta (AA) being replaced because of its isolated pathology and otherwise non-pathological aortic root. METHODS A total of 23 patients (median age 52 years) with the ascending phenotype of proximal aorta aneurysm and ACAO of at least 1 coronary artery localized in the AA being replaced underwent ostial slide plasty to transpose the ACAO to the respective sinus of Valsalva and, consequently, to allow an AA replacement with placement of the proximal anastomosis at the level of the sinotubular junction (STJ). In 15 patients, the aortic valve was bicuspid, and all but 3 patients presented with a relevant valve defect. In addition to remodelling the STJs (all patients), valve-sparing repair or replacement was performed in 12 and 8 patients, respectively. RESULTS No patient died during the entire follow-up (median 72, range 3–183 months). One patient required replacement of a recurrently insufficient valve that was repaired primarily using cusp patch plasty, but there were no further cardiac reoperations nor any re-interventions on the proximal aorta, aortic valve and/or coronary artery ostia. Two patients received peripheral coronary stents (8 and 7 years after surgery, respectively) due to coronary heart disease. CONCLUSIONS Transposition of the ACAO from the replaced AA into the normal sinus of Valsalva using the ostial slide plasty offers a simple and safe surgical option enabling a recreation of a durable STJ at the level of the anastomosis between the root and the aortic graft.

OBJECTIVES We used individual patient data from 4 of the largest contemporary coronary bypass surgery trials to evaluate differences in long-term outcomes when radial artery (RA), right internal thoracic artery (RITA) or saphenous vein graft (SVG) are used to complement the left internal thoracic artery-to-left anterior descending graft. METHODS Primary outcome was all-cause mortality. Secondary outcome was a composite of major adverse cardiac and cerebrovascular events (all-cause mortality, myocardial infarction and stroke). Propensity score matching and Cox regression were used to reduce the effect of treatment selection bias and confounders. RESULTS A total of 10 256 patients (1510 RITA; 1385 RA; 7361 SVG) were included. The matched population consisted of 1776 propensity score-matched triplets. The mean follow-up was 7.9 ± 0.1, 7.8 ± 0.1 and 7.8 ± 0.1 years in the RITA, RA and SVG cohorts respectively. All-cause mortality was significantly lower in the RA versus the SVG [hazard ratio (HR) 0.62, 95% confidence interval (CI): 0.51–0.76, P = 0.003] and the RITA group (HR 0.59, 95% CI 0.48–0.71, P = 0.001). Major adverse cardiac and cerebrovascular event rate was also lower in the RA group versus the SVG (HR 0.78, 95% CI 0.67–0.90, P = 0.04) and the RITA group (HR 0.75, 95% CI 0.65–0.86, P = 0.02). Results were consistent in the Cox-adjusted analysis and solid to hidden confounders. CONCLUSIONS In this pooled analysis of 4 large coronary bypass surgery trials, the use of the RA was associated with better clinical outcomes when compared to SVG and RITA.

Introduction The impact of sex on the outcomes after coronary artery bypass grafting (CABG) is controversial. The majority of CABG studies are retrospectively collected clinical or registry data, women comprise only a minority, and the reported findings represent the male predominated cohort. This individual patient meta-analysis is aimed at evaluating sex-related differences in outcomes after CABG using high quality data from randomized controlled trials (RCTs). Methods and analysis A systematic literature search will be performed to identify all CABG RCTs (minimum follow-up: 5 years). Detailed specification for the minimum deidentified patient records' data requirements will be provided to RCT primary contact to request their deidentified data for pooling. The pooled analysis will follow the prospective register of systematic reviews (PROSPERO) and the preferred reporting items for systematic reviews and meta-analyses for individual patient data systematic reviews (PRISMA-IPD) recommendations and will compare sex-related outcomes after CABG. The main hypothesis is that outcomes after CABG are worse in women than in men. We will also test whether treatment effects for off-pump and the use of multiple arterial grafts are present within each sex, and also, whether there are differential treatment effects between sexes. The primary endpoint will be a composite of all-cause mortality, myocardial infarction, stroke, and repeat revascularization at long-term follow up. Ethics and dissemination Ethics approval and participant consent for the study will be obtained locally by each study team if needed. Data will be disseminated and submitted to peer-reviewed scientific journals and meetings irrespective of study outcome.

In patients with a continuous-flow left ventricular assist device, preimplant predictors of poor physical performance are not well-described. We aimed to identify predictors of inability to walk more than 300 m on 6-minute walk test (6MWT) 6 months after HeartMate 3 implantation.Using data from the European Registry of Patients Implanted With a Full Magnetically Levitated LVAD, patients with available 6MWT at 6 months after implantation were included (N = 194) and grouped according to 6MWT distance (6MWD) of300 m (n = 150) or 6MWD of300 m (n = 44). Patients walking300 m were older (60 ± 10 vs 52 ± 12 years; P.001), more often New York Heart Association functional class IV (63% vs 42%; P = .03), and more often had type 2 diabetes (43% vs 17%; P.001) at implantation. Atrial fibrillation was seen in 57% in those with a 6MWT of300 m vs 31% in those walking longer (P.002). Further, hemoglobin and estimated glomerular filtration rate was lower in those walking300 m (both P.01). In multivariable regression analysis, independent predictors of a 6MWD of300 m were: atrial fibrillation (odds ratio [OR], 3.22; 95% confidence interval [CI], 1.12-8.67), older age (OR for 10-year increment, 2.81; 95% CI, 1.55-5.07), New York Heart Association functional class IV (OR, 3.37; 95% CI, 1.27-8.98), and Interagency Registry for Mechanically Assisted Circulatory Support profile 1 or 2 (OR, 6.53; 95% CI, 1.92-22.19).Six months after HeartMate 3 implantation, 77% of patients walked300 meters in 6 minutes. Apart from age and measures of heart failure severity, atrial fibrillation at implantation is an independent predictor of low 6MWD at 6 months after implantation.

To evaluate the results after selective sinus replacement (SSR) for aortic root remodeling in bicuspid aortopathy.Among 662 patients who underwent root repair using SSR between 2005 and 2020, there were 114 with bicuspid aortopathy. SSR was performed either as an isolated procedure (31) or as an adjunct to aortic valve repair (83) and was adjusted to the existing aortic annulus diameter rather than a downsized diameter. In valves with asymmetrical commissural orientation, the repair aimed for the achievement of a 180°-commissural orientation.Abolishment of aortic insufficiency (AI) ≥2+ using root repair alone was only possible in 2 patients with acute-dissection-related AI, yet isolated root repair was also performed in 29 further patients with no/mild AI. All remaining patients with AI ≥2+ presented cusp-related regurgitation and necessitated an additional valve repair. During the mean follow-up of 91 months (range, 13-196), a relevant valve defect (AI ≥3+ in 8, stenosis in 2) occurred in 10 patients (all after combined repair) resulting in an estimated freedom from a relevant aortic valve defect and/or reoperation of 96 ± 2%, 89 ± 4%, and 82 ± 6% at 5, 10, and 12 years, respectively. Echocardiographically, no patient revealed a considerable change of form or size of the repaired root nor was any root reintervention necessary.Patient-tailored root repair using SSR is a very effective and durable valve-sparing approach for bicuspid aortopathy. Aortic cusp repair is decisive for both abolishment of AI in bicuspid aortopathy and for the functional durability of the repaired aortic valve.

Background A transapical (TA) approach to transcatheter aortic valve replacement (TAVR) may be used when a transfemoral (TF) approach is not feasible. The CHANGE neo TA study evaluated patients treated in routine clinical practice via TA-TAVR with the ACURATE neo bioprosthetic aortic valve. Methods and results This single-arm post-market study had a planned enrolment of 200 subjects; enrolment was terminated early due to declining TA-TAVR procedures at participating centers. Final enrolment was 107 patients (mean age: 79.3 years; 54.2% female; mean STS score at baseline: 6.2%). The mortality rate in the intent-to-treat population was 11.2% at 30 days (primary endpoint) and 25.6% at 12 months. The VARC-2 composite endpoint for 30-day safety occurred in 24.3% of patients. Six patients (5.6%) received a permanent pacemaker within 30 days. Site-reported echocardiographic data showed early improvements in mean aortic valve gradient (baseline: 38.8 [SD 13.1] mmHg, discharge: 6.7 [SD 3.7] mmHg) and effective orifice area (baseline: 0.7 [SD 0.2] cm2, discharge: 1.9 [SD 0.6] cm2), and the discharge rate of paravalvular regurgitation was low (74.7% none/trace, 24.2% mild, 1.1% severe). Conclusions TA-TAVR with the ACURATE neo valve system yields acceptable clinical outcomes, providing an alternative for patients with aortic stenosis who are not candidates for TF-TAVR.

Objectives The study aim was to evaluate long-term results after anatomic restoration of the aortic root. Methods During an 18-year period, a total of 669 patients underwent valve-sparing root repair (aneurysm 554, dissection 115) using selective sinus replacement. None/trivial, mild, moderate, and severe (grades 3+ and 4+) insufficiency were present in 57, 146, 204, and 262 patients, respectively. Results The anatomic repair was adjusted to the existing aortic annulus diameter, which was 27.0 ± 3.0 mm on average. Replacement of 1, 2, or 3 sinuses of Valsalva was performed in 209, 234, and 226 patients, respectively. Altogether, 454 additional procedures on the cusps were performed, mostly as cusp patch plasty with pericardium (210). Thirty-day mortality was 0.6%. The mean follow-up duration was 7.1 ± 4.1 years (range, 0.01-19.1 years). The estimated freedom from relevant aortic insufficiency grade 3+ or greater (15 events) was 98% ± 1%, 97% ± 1%, and 94% ± 3% at 5, 10, and 15 years, respectively. On echocardiogram, no patient revealed a considerable change of the form or size of the repaired root, which was confirmed radiologically in 160 patients who received computed tomography angiography for any reason. Multivariate logistic regression analysis identified cusp prolapse/pseudo-prolapse as the only independent risk factor for the development of recurrent insufficiency grade 2+ or greater (41 occurrences), with a hazard ratio of 3.258 (95% confidence interval, 1.658-6.403; P = .001). An association between aortic annulus size and functional results could not be demonstrated. Conclusions Patient-tailored root repair using isolated sinus replacement offers excellent functional long-term results regardless of underlying root pathology or annulus size. Aortic cusp pathology was decisive for long-term valve function.

Background: The 30-day and 1-year follow-up analysis of the GOPCABE trial (German Off-Pump Coronary Artery Bypass Grafting in Elderly Patients) revealed no significant difference in the composite end point consisting of death, stroke, myocardial infarction, new renal replacement therapy, or repeat revascularization. The 5-year follow-up data of this trial are reported here. Methods: From June 2008 to September 2011, a total of 2539 patients aged ≥75 years were randomly assigned to undergo off-pump or on-pump coronary artery bypass grafting (CABG) at 12 centers in Germany. The primary outcome was all-cause mortality at 5 years. The secondary 5-year outcomes were a composite of death, myocardial infarction, and repeat revascularization. Furthermore, the impact of complete versus incomplete revascularization was assessed. Results: After a median follow-up of 5 years, 361 patients (31%) assigned to off-pump CABG and 352 patients (30%) assigned to on-pump CABG had died (hazard ratio off-pump/on-pump CABG, 1.03; 95% CI, 0.89–1.19; P =0.71). The composite outcome of death, myocardial infarction, and repeat revascularization occurred in 397 (34%) after off-pump and in 389 (33%) after on-pump CABG (hazard ratio, 1.03; 95% CI, 0.89–1.18; P =0.704). Incomplete revascularization occurred in 403 (34%) patients randomly assigned to off-pump and 354 (29%) patients randomly assigned to on-pump CABG ( P P =0.02) after off-pump CABG and 72% (95% CI, 67–76) versus 77% (95% CI, 74–80) after on-pump CABG (log-rank test: P =0.03), respectively. Cox regression analysis revealed a hazard ratio incomplete/complete revascularization of 1.19 (95% CI, 1.01–1.39; P =0.04). Conclusions: In elderly patients ≥75 years of age, the 5-year survival rates and the combined outcome of death, myocardial infarction, and repeat revascularization, as well, were similar after on-pump and off-pump CABG. Incomplete revascularization was associated with a lower 5-year survival rate, irrespective of the type of surgery. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT00719667.

Percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) are considered revascularization procedures, but only CABG can prolong life in stable coronary artery disease. Thus, PCI and CABG mechanisms may differ. Viability and/or ischemia detection to guide revascularization have been unable to accurately predict treatment effects of CABG or PCI, questioning a revascularization mechanism for improving survival. By contrast, preventing myocardial infarction may save lives. However, the majority of infarcts are generated by non-flow-limiting stenoses, but PCI is solely focused on treating flow-limiting lesions. Thus, PCI cannot be expected to significantly limit new infarcts, but CABG may do so through providing flow distal to vessel occlusions. All comparisons of CABG to PCI or medical therapy that demonstrate survival effects with CABG also demonstrate infarct reduction. Thus, CABG may differ from PCI by providing "surgical collateralization," prolonging life by preventing myocardial infarctions. The evidence is reviewed here.

Aims Data suggest that women have worse outcomes than men after coronary artery bypass grafting (CABG), but results have been inconsistent across studies. Due to the large differences in baseline characteristics between sexes, suboptimal risk adjustment due to low-quality data may be the reason for the observed differences. To overcome this limitation, we undertook a systematic review and pooled analysis of high-quality individual patient data from large CABG trials to compare the adjusted outcomes of women and men. Methods and results The primary outcome was a composite of all-cause mortality, myocardial infarction (MI), stroke, and repeat revascularization (major adverse cardiac and cerebrovascular events, MACCE). The secondary outcome was all-cause mortality. Multivariable mixed-effect Cox regression was used. Four trials involving 13 193 patients (10 479 males; 2714 females) were included. Over 5 years of follow-up, women had a significantly higher risk of MACCE [adjusted hazard ratio (HR) 1.12, 95% confidence interval (CI) 1.04–1.21; P = 0.004] but similar mortality (adjusted HR 1.03, 95% CI 0.94–1.14; P = 0.51) compared to men. Women had higher incidence of MI (adjusted HR 1.30, 95% CI 1.11–1.52) and repeat revascularization (adjusted HR 1.22, 95% CI 1.04–1.43) but not stroke (adjusted HR 1.17, 95% CI 0.90–1.52). The difference in MACCE between sexes was not significant in patients 75 years and older. The use of off-pump surgery and multiple arterial grafting did not modify the difference between sexes. Conclusions Women have worse outcomes than men in the first 5 years after CABG. This difference is not significant in patients aged over 75 years and is not affected by the surgical technique.

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.

Seit der letzten Herausgabe der Leitlinien zur Behandlung von Klappenfehlern durch die European Society of Cardiology (ESC) und die European Association for Cardio-Thoracic Surgery (EACTS) im Jahr 2012 sind umfangreiche neue Daten publiziert worden, die eine Neuauflage des Dokuments erforderlich gemacht haben. Dies betrifft insbesondere die kathetergestutzte Behandlung von Klappenerkrankungen, aber auch andere Bereiche wie z. B. die Operationsentscheidung bei asymptomatischer schwerer Klappenerkrankung, die medikamentose Therapie oder die Versorgungsstrukturen. Der vorliegende Kommentar fasst die wesentlichen Neuerungen zusammen und erlautert die Hintergrunde dafur.

Objectives To assess safety and efficacy of transapical transcatheter aortic valve implantation (TA-TAVI) in the absence of predilation using balloon aortic valvuloplasty (BAV). Predilation of the stenosed valve using BAV is a routine step in TA-TAVI; however, evidence supporting its clinical value is lacking, and several studies have linked it with higher complication rates. Methods A prospective, two-armed, multicentre registry (EASE-IT TA) to gather data on patients undergoing TA-TAVI with or without BAV, using the Edwards SAPIEN 3 valve was designed. The primary evaluation criterion was a composite of all-cause mortality, non-fatal stroke, non-fatal myocardial infarction, acute kidney injury and pacemaker implantation [per Valve Academic Research Consortium-2 (VARC-2)] within 30 days after TAVI. Results A total of 198 subjects underwent TA-TAVI, 61 with and 137 without BAV. Patient characteristics were comparable at baseline (mean ± SD: age 80.3 ± 5.7 years; logistic EuroSCORE 20.2 ± 12.6). Similar reductions in peak and mean transvalvular gradients were observed post-procedurally. There was a significant reduction of fluoroscopy time without BAV (4.7 vs 7.9 min; P = 0.039) and significantly decreased odds of catecholamine administration (17.5% vs 32.8%; P = 0.017). A decreased odds of the primary evaluation criterion in patients without BAV after 30 days (adjusted odds ratio 0.71; 95% confidence interval 0.34-1.82) and the same composite end-point after 6 months (adjusted odds ratio 0.74; 95% confidence interval 0.37-1.47) were not significant even after multivariable adjustment. Conclusions TA-TAVI without BAV appears to be at least equal to its conventional counterpart in terms of efficacy and may offer advantages in terms of safety. Thus, there appears to be little justification for maintaining the BAV step in TA-TAVI for many patients.

Background Aim of the study was to determine the impact of right- and left-ventricular systolic dysfunction on perioperative outcome and long-term survival after TAVR. Methods Study population consisted of 702 TAVRs between 2009 and 2014, 345 by TF, 357 by TA route. RV and LV function were determined by TAPSE and LVEF measurement during baseline echocardiography. Patients were divided according to TAPSE (>18 mm/14-18 mm/ 50%/30-50%/

Objective Surgery for acute type A aortic dissection remains a surgical challenge because of prolonged operative times, bleeding complications, and a considerable risk of neurological morbidity and mortality. The following study investigates the clinical results after surgical treatment for acute type A aortic dissection using selective antegrade cerebral perfusion and moderate-to-mild systemic hypothermia (≥28 °C). Methods Between January 2000 and January 2015, 453 consecutive patients underwent surgical treatment for acute type A aortic dissection at two aortic referral centres in Germany. Patient mean age was 67 ± 13 years, 298 patients (66%) were male. Selective unilateral or bilateral cerebral perfusion under moderate-to-mild systemic hypothermia was used in all patients. Ascending aortic replacement, hemiarch replacement and total arch replacement was performed in 9 patients (2%), 342 patients (75%) and 102 patients (23%), respectively. Clinical data were prospectively entered into the institutional databases. Mean late follow-up was 6 ± 3 years and was 98% complete. Results Cardiopulmonary bypass time totalled 181 ± 68 min and the myocardial ischaemic time 107 ± 43 min. Mean duration of selective antegrade cerebral was 46 ± 23 min. Mean lowest core temperature amounted to 28.8 ± 0.6 °C. Unilateral cerebral perfusion was performed in 298 patients (66%) and bilateral in 155 patients (34%). Mean intensive care unit stay was 5 ± 7 days. We observed new postoperative permanent neurological deficits in 27 patients (6%) and transient neurological deficits in 31 patients (7%). Thirty-day mortality was 7% (n = 32). Overall survival rate at 5 years was 77 ± 6%. Conclusions Our data suggest that selective antegrade cerebral perfusion in combination with moderate-to-mild systemic hypothermia (≥28 °C) can be safely and reproducibly applied to surgery for acute type A aortic dissection and offers sufficient neurological and visceral organ protection.

OBJECTIVES There is an ongoing discussion about how to treat coronary stents during bypass surgery: Should patent stents be left alone and the stented vessels be ungrafted, or should every stented coronary artery receive a bypass graft? This study aims to determine the relevance of perioperative stent stenosis or occlusion on postoperative outcomes up to 3 years postoperatively. METHODS Patients undergoing coronary artery bypass grafting surgery (CABG) (±concomitant procedures) with previous percutaneous coronary intervention from 4 centres were prospectively included in this observatory study between April 2015 and June 2017. A coronary angiography was conducted between the fifth and seventh postoperative days. The preoperative and postoperative angiograms were assessed in a core laboratory, assessing the patencies of coronary stents and bypass grafts. The core lab investigators were blinded to the patients’ characteristics and perioperative course. RESULTS A total of 107 patients were included in the study. In the postoperative coronary angiography, 265 bypass grafts and 189 coronary stents were examined angiographically. Ninety-seven percent of preoperatively patent stents remained patent. New coronary stent stenoses were observed in 5 patients (4.7%). All 5 patients were asymptomatic and managed conservatively. Bypass stenoses were observed in 12 patients (11%), of whom were managed conservatively, 4 underwent percutaneous coronary intervention and 1 underwent redo-CABG. Two years postoperatively, 97% of patients were alive. Patients with new stent stenosis tended to have a better survival compared with patients with bypass stenosis (100% vs 73%; P = 0.09) up to 3 years postoperatively. CONCLUSIONS Perioperative coronary stent stenosis occurs rarely. It is safe to leave a patently stented coronary vessel without bypass grafting.

AIMS In the absence of randomised data, we aimed to compare the transapical ACURATE and transfemoral ACURATE neo with the SAPIEN 3 prosthesis using propensity matching. METHODS AND RESULTS From 2012 to 2016, 1,306 patients at three German centres received either the ACURATE/ACURATE neo prosthesis (n=591) or the SAPIEN 3 prosthesis (n=715). Through nearest neighbour matching with exact allocation for access route and centre, pairs of 329 patients (250 transfemoral, 79 transapical) per group were determined. Patients were 81 years old on average and had a logistic EuroSCORE I of 19%. Predilatation and post-dilatation were more frequent in the ACURATE group (97.6% versus 52.1%, p

Background Nonagenarians are at increased risk for morbidity and mortality after transcatheter aortic valve replacement (TAVR) based solely on their age. The aim of our study was to evaluate survival of nonagenarians with severe aortic valve stenosis (AS) after TAVR as compared to an age- and sex-matched general population. Methods From 2009 to 2017, 1052 consecutive patients ≥80 years scheduled for TAVR were included. Patients were divided into three groups depending on their age at the time of the procedure: 80–84 (Group 1), 85–89 (Group 2) and ≥90 years (Group 3). Survival of patients treated with TAVR was compared to the life expectancy of an age- and sex-matched cohort in the general population. Results Nonagenarians were more likely to experience major access-site complications than their younger counterparts (7.6% Group 1 vs. 10.1% Group 2 vs. 17.6% Group 3, p = 0.016). One-year mortality in nonagenarians was higher as compared to the general population (27.8% vs. 20.0%). After two years, the mortality curves between the TAVR patients and the general population converged (39.2% vs. 37.5%) and were lower after five years. Conclusions During the observation period of five years, carefully selected nonagenarians treated with TAVR had at least the same mortality rate as an age- and sex-matched general population after two years despite procedure-associated complications. The negative prognostic impact of the severe AS was completely eliminated by TAVR.

In industrialized countries, the most common etiology of mitral regurgitation (MR) is degenerative mitral valve (MV) disease. The natural history of severe degenerative MR is poor. However, its appropriate and timely correction is associated with a life expectancy similar to that of the normal population. Surgical MV repair is the gold-standard treatment. This review will focus on the most recent evidence with a specific emphasis on surgical indications, timing of treatment, contemporary surgical techniques, Heart Teams, and Centers of Excellence.

Objectives: We sought to determine the effects of experience on the Mitraclip® procedure steps as well as procedure safety and functional results. Background: MR has proven deleterious in heart failure. Mitraclip® therapy evolved an important option in patients with severely reduced left ventricular function (LVEF). Methods: Between 2011 and 2016, 126 consecutive patients were grouped in three groups and investigated in a prospective observational study. We evaluated the duration of procedural steps, safety endpoints, and functional results. Results: The median logistic EuroScore was 32% (7–40%). Ninety-five percent of patients were in NYHA-stage ≥III and 51% had a LVEF

Objectives The aim of the study was to evaluate operative and long-term results after surgery of acute aortic dissection involving the root, in which the proximal repair consisted of curative resection of all dissected aortic sinuses and was performed using either valve-sparing root repair or complete root replacement with a valve conduit. Methods Between August 2002 and March 2013, 162 consecutive patients (mean age 63 ± 14 years) underwent surgery for acute type A aortic dissection. Eighty-six patients with an involvement of the aortic root underwent curative surgery of the proximal aorta consisting of valve-sparing root repair (n = 54, 62.8%) or complete valve and root replacement using composite valve grafts (n = 32, 37.2%). In patients with root repair, all dissected aortic walls were resected and root remodelling using the single patch technique (n = 53) or root repair with valve reimplantation (n = 1) was performed without the use of any glue. All perioperative data were collected prospectively and retrospective statistical examination was performed using univariate and multivariate analyses. Results The mean follow-up was 5.2 ± 3.5 years for all patients (range 0-12 years) and 6.1 ± 3.3 years for survivors. The 30-day mortality rate was 5.8% (5 patients), being considerably lower in the repair sub-cohort (1.9 vs 12.5%). The estimated survival rate at 5 and 10 years was 80.0 ± 4.5 and 69.1 ± 6.7%, respectively. No patient required reoperation on the proximal aorta and/or aortic valve during the follow-up time and there were only two valve-related events (both embolic, one in each group). Among those patients with repaired valves, the last echocardiography available showed no insufficiency in 40 and an irrelevant insufficiency (1+) in 14. Conclusions Curative repair of the proximal aorta in acute dissection involving the root provides favourable operative and long-term outcome with very low risk of aortic complications and/or reoperations, regardless if a valve-sparing procedure or replacement with a valve conduit is used. Valve-sparing surgery is frequently suitable, providing excellent outcome and very high durability.

OBJECTIVES Surgical management of chronic aortic dissection is controversial, especially when the dissection extends into the abdominal aorta in which the visceral arteries originate from different lumens and is combined with aortic arch pathology necessitating surgery. The aim of the study was to evaluate the results of open surgery in this complex aortic pathology. METHODS Between June 2002 and 2015, a total of 17 patients (median age 57, range 32-76 years) necessitating complete arch replacement presented complex chronic dissection of the thoraco-abdominal aorta with the visceral arteries originating from different lumens. Fourteen patients (82%) had had previous cardiac surgery, which was performed on the proximal aorta in all but one because of acute type A dissection. Nine patients without considerable dilatation of the descending aorta received aortic arch replacement with distal resection of the dissection membrane, and 8 patients with progressive dilatation of the thoracic aorta underwent aortic arch and descending aorta replacement via clamshell approach. RESULTS No early (defined as 30-day, 90-day and in-hospital period) deaths, strokes or spinal cord injuries occurred. Only 1 patient (6%) presented temporary neurological dysfunctions (delirium, agitation), which resolved completely before discharge, and an injury of the recurrent laryngeal nerve was documented in 2 patients (12%). Temporary dialysis was necessary in 1 case. The follow-up was complete for all patients. All but one patient, who died due to leukaemia 23 months after surgery, were alive at the last follow-up (median duration 33 months, range 2-118 months). No patient needed a reoperation or an intervention on the thoracic and/or abdominal aorta. Moreover, no noticeable progression of the chronic dissection in the downstream aorta was documented in any patient. CONCLUSIONS The results after conventional aortic arch repair with distal resection of the dissection membrane and, if necessary, with replacement of the progressively dilated chronic dissected thoracic aorta can offer excellent results in experienced hands and, therefore, this technique may be considered as a preferable option for surgical treatment of chronic aortic dissection with involvement of the aortic arch and the visceral arteries originating from different lumens.

Objectives The aim of the study was to evaluate the surgical and neurological outcomes after aortic arch surgery using unilateral cerebral perfusion. Methods Between June 2004 and February 2017, a total of 1000 patients (mean age 63 ± 12; range, 14-88 years) with nonacutely dissected aortic pathology (aneurysm, porcelain aorta, chronic dissection, infection, and injury in 89.1%, 4.9%, 4.1%, 1.6%, and 0.3%, respectively) underwent aortic arch surgery using unilateral cerebral perfusion for brain protection using mild hypothermia. A previous neurological event with residuals was documented in 3.6% of the patients and 12.2% had received previous cardiovascular surgery. The surgery comprised total/subtotal arch repair (with involvement of at least 1 supra-aortic artery) or hemiarch replacement in 346 and 654 patients, respectively. The aortic valve was replaced in 521 (including 190 valve composite grafts) and repaired in 380 patients (284 valve-sparing root repairs). Results The unilateral cerebral perfusion (mean duration 23.3 ± 17.2; range, 6-105 minutes) was performed via cannulated common carotid or innominate artery and aimed for a pressure-controlled (70-100 mm Hg) flow (mean flow, 1.4 ± 0.3 L/min; mean pressure, 90.1 ± 20.1 mm Hg) at a constant blood temperature of 28°C for ensuring the patency of collateral pathways. The circulatory arrest of the lower body (mean duration 18.4 ± 9.9 minutes) was performed at a rectal temperature of 31.2 ± 1.8°C. Early (30-day) and in-hospital mortality was 1.3% and 2.1%, respectively; the rates of permanent neurological deficit and transient neurological dysfunctions were 1.0% and 4.9%, respectively. Conclusions Unilateral cerebral perfusion performed in the described conditions is highly effective for cerebral protection in aortic arch surgery.

Percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) are considered revascularization procedures, but only CABG can prolong life in stable coronary artery disease. Thus, PCI and CABG mechanisms may differ. Viability and/or ischemia detection to guide revascularization have been unable to accurately predict treatment effects of CABG or PCI, questioning a revascularization mechanism for improving survival. By contrast, preventing myocardial infarction may save lives. However, the majority of infarcts are generated by non-flow-limiting stenoses, but PCI is solely focused on treating flow-limiting lesions. Thus, PCI cannot be expected to significantly limit new infarcts, but CABG may do so through providing flow distal to vessel occlusions. All comparisons of CABG to PCI or medical therapy that demonstrate survival effects with CABG also demonstrate infarct reduction. Thus, CABG may differ from PCI by providing "surgical collateralization," prolonging life by preventing myocardial infarctions. The evidence is reviewed here.

Background The aim of the study was to evaluate operative and long-term results after acute type A aorta dissection (AAAD) operation, in which complete resection of all dissected aortic segments (curative repair) was achieved. Methods Among 205 consecutive patients operated on between 2002 and 2014 because of AAAD were 88 patients (42.9%), in whom the dissection did not extend into the downstream aorta. The distal extension of the dissection ended before the origin of the innominate artery in 50 patients of the study cohort (56.8%) or extended throughout the arch, necessitating a total/subtotal arch replacement to achieve a curative distal repair in 38 remaining patients (43.2%). The aortic root was involved in 52 patients (59.1%) and was repaired using valve-sparing repair (31) or replacement with a valve composite graft (21). Combination of root and open arch surgery was reported in 46 patients (52.3%). Results Thirty-day and in-hospital mortalities were 3.4% and 5.7%, respectively. Survival was estimated starting with the operation and was 81.9% ± 4.5% and 56.6% ± 8.7% at 5 and 10 years, respectively. No patient required reoperation on the aortic root and/or distal thoracoabdominal aorta; however 2 cardiac reoperations were unrelated to the primary surgical procedure. Moreover, the freedom of aortic and/or sudden/unknown death was 100%. Conclusions Curative aortic repair can be achieved in a relevant share of AAAD patients and is mostly limited by the distal extension of dissection. This kind of repair is advisable, whenever possible, because it can provide very low risk of aortic complications and/or reoperations over time.

OBJECTIVES Transapical transcatheter aortic valve implantation (TAVI) is associated with increased mortality as compared to the transfemoral (TF) access. Possible mechanisms include different patient risk profiles as well as an intrinsic injury caused by the access route itself. METHODS All consecutive patients scheduled for TAVI between January 2009 and June 2016 at a single centre were evaluated. A comparison of 30-day mortality and morbidity rates for patients undergoing TF or transapical (TA) TAVI was performed according to the criteria of the Valve Academic Research Consortium 2. RESULTS During the investigated period, 1130 patients (TF: n = 619, TA: n = 511) were scheduled for TAVI. TA patients had a higher operative risk profile (logistic EuroSCORE: 24% vs 17%; P

Background Coronary artery bypass grafting (CABG) without cardiopulmonary bypass (off-pump CABG) may reduce severe adverse events including stroke. Methods In the German Off-Pump Coronary Artery Bypass Grafting in Elderly patients trial, the rate of major adverse cardiovascular events was compared in 2,394 elderly (≥ 75 years) patients undergoing CABG with (on-pump) or without (off-pump) cardiopulmonary bypass. This exploratory post-hoc analysis investigated the impact of surgical aortic manipulation on the rate of stroke. Results There was no significant difference in the rate of stroke within 30 days after surgery between both groups (off-pump: 2.2%; on-pump: 2.7%; odds ratio [OR]: 0.83 [0.5–1.38]; p = 0.47). Within the off-pump group, different degrees of aortic manipulation did not lead to significant different stroke rates (tangential clamping: 2.3%; OR 0.86 [0.46–1.60]; clampless device: 1.8%; OR 0.67 [0.26–1.75]; no aortic manipulation: 2.4%; OR 0.88 [0.37–2.14]). An aggregate analysis including more than 10,000 patients out of the four recent major trials also yielded comparable stroke rates for on- and off-pump CABG (off-pump: 1.4%; on-pump: 1.7%; OR 0.87 [0.64–1.20]). Conclusion Within recent prospective randomized multicenter trials off-pump CABG did not result in lower stroke rates. The possible intrinsic benefit of off-pump CABG may be offset by the complexity of the operative therapy as well as the multiple pathomechanisms involved in perioperative stroke.

ObjectiveAt this consensus conference, we developed evidence-informed consensus statements and recommendations on the practice of off-pump coronary artery bypass graft (OPCAB) by systematically reviewing and performing meta-analysis of the randomized controlled trials (RCTs) comparing OPCAB and conventional coronary artery bypass (CCAB).MethodsAll RCTs of OPCAB versus CCAB through April 2013 were screened, and 102 relevant RCTs (19,101 patients) were included in a systematic review and meta-analysis (15 RCTs of 9551 high-risk patients; and 87 RCTs of 9550 low-risk patients) in accordance with the Cochrane Collaboration and PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) methodology. Consensus statements for the risks and benefits of OPCAB surgery in mortality, morbidity, and resource use were developed based on best available evidence.ResultsCompared to CCAB, it is reasonable to perform OPCAB to reduce risks of stroke [class IIa, level of evidence (LOE) A], renal dysfunction/failure (class IIa, LOE A), blood transfusion (class I, LOE A), respiratory failure (class I, LOE A), atrial fibrillation (class I, LOE A), wound infection (class I, LOE A), ventilation time, and ICU and hospital length of stay (class I, LOE A). However, OPCAB may be associated with a reduced number of grafts performed (class I, LOE A) and with diminished graft patency (class IIa, LOE A, with increased coronary reintervention at 1 year and beyond (class IIa, LOE A), as well as increased mortality at a median follow-up of 5 years (class IIb, LOE A).ConclusionsOPCAB compared with CCAB may improve outcomes in the short-term (stroke, renal dysfunction, blood transfusion, respiratory failure, atrial fibrillation, wound infection, ventilation time, and length of stay). However, over the longer-term, OPCAB may be associated with reduced graft patency, and increased risk of cardiac re-intervention and death.

The 25th German Heart Report provides a comprehensive analysis of morbidity and mortality in patients with selected heart diseases as well as services and care in cardiology and cardiac surgery in Germany during the period 2011–2012. It is the result of a multidisciplinary collaboration between the German Heart Foundation, the German Cardiac Society, the German Society for Thoracic and Cardiovascular Surgery, and the German Society of Pediatric Cardiology and is based on data from different sources. In addition, trends of the period from 1995 to 2012 are presented. The trends in morbidity due to cardiac diseases in 2010 and previous years continued in 2011. Compared with data from 1995 to 2010, one can observe: Compared with data from 2009, the mortality rates in 2011 differ somewhat; there is: These data are in agreement with findings from other Western countries. Coronary heart disease, the most frequent cardiac disease, has continuously decreased in frequency and mortality since 2000. The underlying reasons are discussed. This report is an important resource for all parties of the healthcare system regarding heart disease conditions and their treatment in Germany.

Surgical aortic valve replacement is still considered the first-line treatment for patients suffering from severe aortic valve stenosis. In recent years, transcatheter aortic valve implantation (TAVI) has emerged as an alternative for selected high-risk patients. According to the latest results of the German external quality assurance program, mandatory by law, the initially very high mortality and procedural morbidity have now decreased to approximately 6 and 12%, respectively. Especially in Germany, the number of patients treated by TAVI has increased exponentially. In 2013, a total of 10.602 TAVI procedures were performed. TAVI is claimed to be minimally invasive. This is true concerning the access, but it does not describe the genuine complexity of the procedure, defined by the close neighborhood of the aortic valve to delicate intracardiac structures. Hence, significant numbers of life-threatening complications may occur and have been reported. Owing to the complexity of TAVI, there is a unanimous concordance between cardiologists and cardiac surgeons in the Western world demanding a close heart team approach for patient selection, intervention, handling of complications, and pre- as well as postprocedural care, respectively. The prerequisite is that TAVI should not be performed in centers with no cardiac surgery on site. This is emphasized in all international joint guidelines and expert consensus statements. Today, a small number of patients undergo TAVI procedures in German hospitals without a department of cardiac surgery on site. To be noted, most of these hospitals perform less than 20 cases per year. Recently, the German Cardiac Society (DGK) published a position paper supporting this practice pattern. Contrary to this statement and concerned about the safety of patients treated this way, the German Society for Thoracic and Cardiovascular Surgery (DGTHG) still fully endorses the European (ESC/EACTS) and other actual international guidelines and consensus statements. Only the concomitance of departments for cardiac surgery and cardiology on site can provide optimal TAVI care. This commentary by the DGTHG delineates the data and resources upon which its opinion is based.

OBJECTIVES: Patients undergoing coronary bypass grafting (CABG) are at higher risk if they suffer from atrial fibrillation (AF). It was suggested that performing CABG without the use of cardiopulmonary bypass (off-pump) would reduce perioperative risk. We assessed the influence of preoperative AF on outcome in a randomized cohort of patients above the age of 75 undergoing either on-pump or off-pump CABG. METHODS: The German Off-Pump Coronary Artery Bypass grafting in the Elderly trial, a randomized, controlled multicentre trial conducted at 12 German institutions, enrolled 2303 patients between 2008 and 2011. The presence of AF was recorded at admission and discharge. There was no record on the rhythm status during hospital stay. RESULTS: AF at admission was present in 5% in the on-pump (121/1158) and 5% in the off-pump (112/1145) group. The number of patients with AF at discharge was not different between these two groups (10% on pump, 10% off pump). As expected, AF patients had worse preoperative conditions, which had a negative impact on outcome: The combined end-point of death, infarction, stroke, dialysis and revascularization occurred more often (13 vs 8%, P= 0.008) and 30-day mortality was significantly higher (6 vs 2%, P= 0.003) in AF patients. However, the operative technique used for CABG did not affect these outcome parameters. CONCLUSIONS: AF at admission is a significant risk factor for elderly patients undergoing coronary bypass grafting. However, this risk is not altered by performing bypass grafting off pump.

Objectives The aim of the study was to evaluate operative techniques and long-term results after aortic valve or root repair in patients aged 75 years or more. Methods Between November 2002 and January 2016, a total of 815 patients underwent aortic valve or root repair. Among them were 100 patients aged 75 years or more (mean, 78 ± 3; range, 75-88 years), including 17 patients operated on an emergency basis because of acute aortic dissection. None/trivial, mild, moderate, and severe insufficiency grades were presented in 9, 23, 27, and 41 patients, respectively. The surgery comprised root repair, cusp repair, and a combination of both in 45, 16, and 39 patients, respectively. Results Early (30-day) mortality and the rate of permanent neurologic deficit were 2% for each. The follow-up was 99% complete, resulting in 427 patient/years. During the follow-up period (mean duration, 4.3 ± 3.2; range, 0.02-11.1 years), only 1 patient developed a relevant aortic insufficiency and required aortic valve reoperation. There were 24 late deaths, which occurred on average 50.0 ± 40.6 months (range, 2.4-135.0) after surgery at the average patient age of 82 ± 5 years (range, 75-90). Estimated survival at 5 and 8 years was 76.4% ± 5.1% and 71.3% ± 5.9%, respectively, and was similar to those of the sex- and age-matched general population. Conclusions Reconstructive aortic valve surgery is a suitable and justifiable surgical option in selected elderly patients undergoing operation by surgeons with considerable experience in this kind of surgery. It offers low cardiac and valve-related mortality and morbidity, leading to life expectancy applicable to the patients' ages.

AIMS We aimed to evaluate the effect of omitting predilation on feasibility, procedural results and safety in balloon-expandable TAVI. METHODS AND RESULTS We performed an analysis of all 680 patients scheduled for a balloon-expandable TAVI prosthesis between January 2011 and August 2016. Patients treated with or without predilation were compared. Procedure times decreased from 85.6±42.9 to 56.7±26.1 minutes (p

Aims Long-term outcomes are available for first-generation transcatheter heart valves but data on second-generation devices are scarce. We aimed to provide an oversight of all patients implanted with a second-generation valve in our centre. Methods and results From April 2012 to July 2016, 219 patients were enrolled in this prospective single-centre experience; they received either the transapical ACURATE TA (n=99) or the transfemoral ACURATE neo (n=120) prosthesis. Data were collected during the hospital stay and telephone follow-ups were conducted at 30 days post procedure and annually thereafter. Patients were 80.9±4.4 years old with a mean logistic EuroSCORE I of 19.3±13.9%. Transapical patients had significantly more comorbidities at baseline. Post intervention, mean gradient was reduced to 10.6±9.2 mmHg, and 1.9% had moderate paravalvular regurgitation. Mean follow-up time, based on the last patient contact, was 217±188 days for the transfemoral and 525±413 days for the transapical group. Thirty-day mortality was 2.5% and 4.0%, and one-year Kaplan-Meier survival was 94.8% (95% CI: 87.5-97.9) and 81.9% (95% CI: 72.0-88.5), respectively. At two years, survival was 64.9% (95% CI: 52.6-74.7) for transapical patients. Conclusions This early single-centre experience showed very good safety and performance outcomes in patients treated with the ACURATE prostheses.

Background and Purpose— The optimal operative strategy in patients with severe carotid artery disease undergoing coronary artery bypass grafting (CABG) is unknown. We sought to investigate the safety and efficacy of synchronous combined carotid endarterectomy and CABG as compared with isolated CABG. Methods— Patients with asymptomatic high-grade carotid artery stenosis ≥80% according to ECST (European Carotid Surgery Trial) ultrasound criteria (corresponding to ≥70% NASCET [North American Symptomatic Carotid Endarterectomy Trial]) who required CABG surgery were randomly assigned to synchronous carotid endarterectomy+CABG or isolated CABG. To avoid unbalanced prognostic factor distributions, randomization was stratified by center, age, sex, and modified Rankin Scale. The primary composite end point was the rate of stroke or death at 30 days. Results— From 2010 to 2014, a total of 129 patients were enrolled at 17 centers in Germany and the Czech Republic. Because of withdrawal of funding after insufficient recruitment, enrolment was terminated early. At 30 days, the rate of any stroke or death in the intention-to-treat population was 12/65 (18.5%) in patients receiving synchronous carotid endarterectomy+CABG as compared with 6/62 (9.7%) in patients receiving isolated CABG (absolute risk reduction, 8.8%; 95% confidence interval, −3.2% to 20.8%; P WALD =0.12). Also for all secondary end points at 30 days and 1 year, there was no evidence for a significant treatment-group effect although patients undergoing isolated CABG tended to have better outcomes. Conclusions— Although our results cannot rule out a treatment-group effect because of lack of power, a superiority of the synchronous combined carotid endarterectomy+CABG approach seems unlikely. Five-year follow-up of patients is still ongoing. Clinical Trial Registration— URL: https://www.controlled-trials.com . Unique identifier: ISRCTN13486906.

OBJECTIVES: The ACURATE TATM system is a self-expanding transcatheter heart valve system designed for transapical access which has been proven to be safe and effective in the controlled setting of clinical trials. The SAVI-1 and SAVI-2 registries aimed to assess whether these promising outcomes can be translated into all-comers clinical routine. METHODS: From November 2011 to 2012 (SAVI-1), and November 2013 to 2014 (SAVI-2), a total of 500 patients were enrolled in the prospective, all-comers, multicentre, multinational SAVI registries. Patients were treated according to the standard of care at their respective hospitals. We report and compare 30-day and 1-year clinical outcomes between SAVI-1 and -2. RESULTS: Patients were 80.8 ± 6.1 years old, the mean logistic EuroSCORE-I was 23.4 ± 14.3%. Valves were deployed under rapid pacing in 71.3% of the procedures in SAVI-1, and in 3.6% in SAVI-2. There was no relevant difference in clinical and echocardiographic outcomes between SAVI-1 and SAVI-2. Overall mortality at 30 days and 1 year was 6.8% and 19.9%, the stroke rate was 2.2% and 3.7%, respectively; 10.2% of patients had received a permanent pacemaker, and no transcatheter valve-related complications after discharge were observed. Paravalvular leakage ≥2+ was reported in 1.9% of the patients at the early follow-up, and in 2.6% at the 1-year follow-up. CONCLUSIONS: The SAVI-registries have confirmed that transapical implantation using the ACURATE TATM device is safe and effective in an all-comers setting with low complication rates and stable performance outcomes at short-term and 1 year; outcomes were similar between SAVI-1 and -2. ClinicalTrials.gov: NCT02663375

Functional mitral regurgitation (FMR) is common in patients with advanced heart failure and impaired left ventricular function. The study aim was to examine functional and hemodynamic effects at three months after MitraClip® implantation in high-risk surgical patients with FMR.A group of 93 patients was rejected for surgical treatment by heart-team decisions due to an inacceptable risk for conventional mitral valve surgery. Between October 2011 and May 2015, 89 of these patients (96%) were treated successfully with MitraClip implantation. A subsequent complete follow up was performed over three months in 32 patients with FMR, including pro-brain natriuretic peptide (pro-BNP) measurements, six-minute walk test, echocardiography, and right heart catheterization.The patients (mean age 73 ± 7 years) presented with a mean left ventricular ejection fraction (LVEF) of 32 ± 13%, and mitral regurgitation (MR) grade ≥3 in 30 of 32 cases (93%). All patients suffered from severe FMR and were highly symptomatic (NYHA functional class III or IV). The mean logistic EuroSCORE was 33%. MitraClip implantation resulted in a significant clinical improvement and reverse cardiac remodelling with a decrease in LV end-diastolic and LV endsystolic diameters, while LVEF was unchanged. In addition, a statistically relevant reduction of systolic, diastolic and mean pulmonary artery pressures (PAPsystolic -7.2 mmHg, p = 0.011; PAPdiastolic -4.5 mmHg, p = 0.003; and PAPmean -5.3 mmHg, p = 0.007) were measured, while the cardiac index (+0.3 l/min/m2, p0.001) and cardiac output (+0.5 l/min, p0.001) were increased significantly. The 30-day mortality was 8.6% (n = 8).Among the study population, MitraClip implantation led to clinical improvement, reverse cardiac remodeling, and a sustained hemodynamic benefit during the three-month follow up period.

OBJECTIVES: The study was aimed to evaluate operative and long-term results after complete root replacement using self-assembled valve composite grafts in patients with a small aortic annulus. METHODS: Among 547 consecutive patients who received the Bentall procedure between 2000 and 2012, a total of 29 patients (61 ± 10; range 42–79 years) had an annulus of ≤20 mm (mean 19.0 ± 0.9). Patients with a native aortic valve (22) suffered from stenosis, insufficiency or mixed defect in 10, 10 and 2 cases, respectively. Among the remaining 7 patients with an artificial aortic valve, there were 3 symptomatic prosthesis–patient mismatches, 3 valve prosthesis deteriorations (1 structural and 2 none-structural) and 1 paravalvular leak. Indication for aortic root replacement was true or false aneurysm, porcelain aorta and intraoperative aortic wall injury in 17, 6 and 6 patients, respectively. RESULTS: The composite graft for complete aortic root replacement was assembled using a mechanical (26) or biological (3) valve prosthesis placed inside a vascular graft with a median size of 24 (range 22–26) mm. The margin of the tube beneath the valve was anastomosed to the aortic annulus, and coronary ostia were implanted in the usual manner. The mean transvalvular gradient at discharge was 10.8 ± 3.9 mmHg and remained virtually unchanged at the follow-up completed for all patients. Early mortality was 0. During the mean follow-up of 95.8 ± 43.7 months, 2 patients died (54 and 146 months after surgery) due to pulmonary embolism and myocardial infarction, respectively. CONCLUSIONS: In patients with a small aortic annulus who need complete aortic root replacement, an oversizing of the valve can be easily achieved using modified, self-assembled composite grafts. Offering excellent haemodynamic characteristics, these grafts lead to prevention of prosthesis–patient mismatch and result in very good and durable functional and clinical results.

During the past decade, many surgeons have focused their interest on the development and improvement of minimally invasive techniques for aortic valve replacement. Although the minimally invasive approaches for the treatment of mitral valve disease have been standardized, the preferred route for aortic valve replacement remains a matter of debate. Access through a right minithoracotomy avoids opening the sternum; however, it requires a greater surgical ability and a learning period, even for experienced surgeons. This enhances the role of sutureless prostheses because these devices are associated with easier placement, excellent hemodynamic performance, and acceptable rates of pacemaker implantation and paravalvular leak. Herein, we report a series of 10 consecutive patients who received an EDWARDS INTUITY rapid deployment valve (Edwards Lifesciences, Irvine, CA USA) by a right minithoracotomy.