Oral Anticoagulation Use and Left Atrial Appendage Occlusion in LAAOS III.

BACKGROUND: LAAOS III (Left Atrial Appendage Occlusion Study III) showed that left atrial appendage (LAA) occlusion reduces the risk of ischemic stroke or systemic embolism in patients with atrial fibrillation undergoing cardiac surgery. This article examines the effect of LAA occlusion on stroke reduction according to variation in the use of oral anticoagulant (OAC) therapy. METHODS: Information regarding OAC use was collected at every follow-up visit. Adjusted proportional hazards modeling, including using landmarks of hospital discharge, 1 and 2 years after randomization, evaluated the effect of LAA occlusion on the risk of ischemic stroke or systemic embolism, according to OAC use. Adjusted proportional hazard modeling, with OAC use as a time-dependent covariate, was also performed to assess the effect of LAA occlusion, according to OAC use throughout the study. RESULTS: At hospital discharge, 3027 patients (63.5%) were receiving a vitamin K antagonist, and 879 (18.5%) were receiving a non-vitamin K antagonist oral anticoagulant (direct OAC), with no difference in OAC use between treatment arms. There were 2887 (60.5%) patients who received OACs at all follow-up visits, 1401 (29.4%) who received OAC at some visits, and 472 (9.9%) who never received OACs. The effect of LAA occlusion on the risk of ischemic stroke or systemic embolism was consistent after discharge across all 3 groups: hazard ratios of 0.70 (95% CI, 0.51-0.96), 0.63 (95% CI, 0.43-0.94), and 0.76 (95% CI, 0.32-1.79), respectively. An adjusted proportional hazards model with OAC use as a time-dependent covariate showed that the reduction in stroke or systemic embolism with LAA occlusion was similar whether patients were receiving OACs or not. CONCLUSIONS: The benefit of LAA occlusion was consistent whether patients were receiving OACs or not. LAA occlusion provides thromboembolism reduction in patients independent of OAC use.

Prognostic benefits of early vascular surgical intervention in patients with major peripheral vascular complications following transcatheter aortic valve implantation.

OBJECTIVES: This study aimed to analyze the incidence, surgical management of major vascular complications, and outcomes in patients undergoing transfemoral (TF) transcatheter aortic valve replacement (TAVR) at our center after strict selection of the access route, carefully considering all known major predictors. METHODS: Data of 494 consecutive patients with pre-interventional multi-slice computed tomography (CT) of the aorta who had undergone TF TAVR from 2009 to 2019 were analyzed. RESULTS: In total, 23/494 (4.7%) patients had major vascular and access-related complications of peripheral vessels and/or infrarenal aorta. These included hematomas that met the Valve Academic Research Consortium 3-criteria of major vascular complications (7/494, 1.4%), arterial dissections (3/494, 0.6%), pseudoaneurysm (6/494, 1.2%), thrombus of the external iliac artery leading to acute limb ischemia (1/494, 0.2%), fistula (1/494, 0.2%), and perforation (5/494, 1.0%). In total, 17/23 (73.9%) major vascular complications required immediate endovascular and/or open surgery. In 16/17 (94%) cases, only 1 surgical procedure was performed. The long-term survival of patients with and without major vascular complications of the peripheral vessels was determined after 2 years. CONCLUSIONS: Early vascular surgery intervention reversed the mortality disadvantage in patients with major complications of the peripheral vessels after TAVR. This underscores the importance of immediate vascular surgery stand-by as an indispensable requirement.

Cost Implications of Left Atrial Appendage Occlusion During Cardiac Surgery: A Cost Analysis of the LAAOS III Trial.

Background The LAAOS III (Left Atrial Appendage Occlusion Study) clinical trial demonstrated that concomitant left atrial appendage (LAA) occlusion leads to a lower risk of ischemic stroke or systemic embolism compared with no occlusion in participants with atrial fibrillation and a CHA2DS2-VASc score of ≥2 undergoing cardiac surgery for another indication. We report the cost implications of concomitant LAA occlusion during cardiac surgery. Methods and Results Using LAAOS III data, we compared the costs (in US dollars) associated with LAA occlusion to no occlusion from the perspective of the Centers for Medicare and Medicaid Services. We calculated the average cost per participant during the trial by applying Medicare reimbursement costs to cardiovascular events for all trial participants. We conducted sensitivity analyses, varying the cost of stroke ±25% and occlusion technique use. Cost neutrality was defined as a mean cost difference within ±5% of the cost per participant in the no-occlusion group. Total study cost per participant was $3878 in the LAA occlusion group and $4490 in the no-occlusion group, a mean difference of -$612 (95% CI, -$1276 to $45). The main drivers of cost savings were fewer stroke events during the trial (mean difference of -$1021). In sensitivity analyses, LAA occlusion was cost saving for suture and stapler techniques but more expensive with closure device. Conclusions Concomitant LAA occlusion was cost saving for participants in LAAOS III. Our findings support concomitant LAA occlusion as an economically dominant strategy for patients with atrial fibrillation and a CHA2DS2-VASc score of ≥2 undergoing cardiac surgery.

Statin loading before coronary artery bypass grafting: a randomized trial.

AIMS: Evidence suggests that a high-dose statin loading before a percutaneous coronary revascularization improves outcomes in patients receiving long-term statins. This study aimed to analyse the effects of such an additional statin therapy before surgical revascularization. METHODS AND RESULTS: This investigator-initiated, randomized, double-blind, and placebo-controlled trial was conducted from November 2012 to April 2019 at 14 centres in Germany. Adult patients (n = 2635) with a long-term statin treatment (≥30 days) who were scheduled for isolated coronary artery bypass grafting (CABG) were randomly assigned to receive a statin-loading therapy or placebo at 12 and 2 h prior to surgery using a web-based system. The primary outcome of major adverse cardiac and cerebrovascular events (MACCE) was a composite consisting of all-cause mortality, myocardial infarction (MI), and a cerebrovascular event occuring within 30 days after surgery. Key secondary endpoints included a composite of cardiac death and MI, myocardial injury, and death within 12 months. Non-statistically relevant differences were found in the modified intention-to-treat analysis (2406 patients; 1203 per group) between the statin (13.9%) and placebo groups (14.9%) for the primary outcome [odds ratio (OR) 0.93, 95% confidence interval (CI) 0.74-1.18; P = 0.562] or any of its individual components. Secondary endpoints including cardiac death and MI (12.1% vs. 13.5%; OR 0.88, 95% CI 0.69-1.12; P = 0.300), the area under the troponin T-release curve (median 0.398 vs. 0.394 ng/ml, P = 0.333), and death at 12 months (3.1% vs. 2.9%; P = 0.825) were comparable between treatment arms. CONCLUSION: Additional statin loading before CABG failed to reduce the rate of MACCE occuring within 30 days of surgery.

Radial artery versus saphenous vein versus right internal thoracic artery for coronary artery bypass grafting.

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.

Sex differences in outcomes after coronary artery bypass grafting: a pooled analysis of individual patient data.

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.

Left Atrial Appendage Occlusion during Cardiac Surgery to Prevent Stroke.

BACKGROUND: Surgical occlusion of the left atrial appendage has been hypothesized to prevent ischemic stroke in patients with atrial fibrillation, but this has not been proved. The procedure can be performed during cardiac surgery undertaken for other reasons. METHODS: We conducted a multicenter, randomized trial involving participants with atrial fibrillation and a CHA2DS2-VASc score of at least 2 (on a scale from 0 to 9, with higher scores indicating greater risk of stroke) who were scheduled to undergo cardiac surgery for another indication. The participants were randomly assigned to undergo or not undergo occlusion of the left atrial appendage during surgery; all the participants were expected to receive usual care, including oral anticoagulation, during follow-up. The primary outcome was the occurrence of ischemic stroke (including transient ischemic attack with positive neuroimaging) or systemic embolism. The participants, research personnel, and primary care physicians (other than the surgeons) were unaware of the trial-group assignments. RESULTS: The primary analysis population included 2379 participants in the occlusion group and 2391 in the no-occlusion group, with a mean age of 71 years and a mean CHA2DS2-VASc score of 4.2. The participants were followed for a mean of 3.8 years. A total of 92.1% of the participants received the assigned procedure, and at 3 years, 76.8% of the participants continued to receive oral anticoagulation. Stroke or systemic embolism occurred in 114 participants (4.8%) in the occlusion group and in 168 (7.0%) in the no-occlusion group (hazard ratio, 0.67; 95% confidence interval, 0.53 to 0.85; P = 0.001). The incidence of perioperative bleeding, heart failure, or death did not differ significantly between the trial groups. CONCLUSIONS: Among participants with atrial fibrillation who had undergone cardiac surgery, most of whom continued to receive ongoing antithrombotic therapy, the risk of ischemic stroke or systemic embolism was lower with concomitant left atrial appendage occlusion performed during the surgery than without it. (Funded by the Canadian Institutes of Health Research and others; LAAOS III ClinicalTrials.gov number, NCT01561651.).

Sex-related differences in outcomes after coronary artery bypass surgery-A patient-level pooled analysis of randomized controlled trials: rationale and study protocol.

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.

Randomized Trials in Cardiac Surgery: JACC Review Topic of the Week.

Compared with randomized controlled trials (RCTs) in medical specialties, RCTs in cardiac surgery face specific issues. Individual and collective equipoise, rapid evolution of the surgical techniques, as well as difficulties in obtaining funding, and limited education in clinical epidemiology in the surgical community are among the most important challenges in the design phase of the trial. Use of complex interventions and learning curve effect, differences in individual operators' expertise, difficulties in blinding, and slow recruitment make the successful completion of cardiac surgery RCTs particularly challenging. In fact, over the course of the last 20 years, the number of cardiac surgery RCTs has declined significantly. In this review, a team of surgeons, trialists, and epidemiologists discusses the most important challenges faced by RCTs in cardiac surgery and provides a list of suggestions for the successful design and completion of cardiac surgery RCTs.

Risk of perioperative coronary stent stenosis or occlusion in patients with previous percutaneous coronary intervention undergoing coronary artery bypass grafting surgery.

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.

Five-Year Outcome After Off-Pump or On-Pump Coronary Artery Bypass Grafting in Elderly Patients.

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<0.001). Five-year survival rates were 72% (95% CI, 67-76) with incomplete versus 76% (95% CI, 74-80) with complete revascularization (log-rank test: 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.

Transfemoral versus transapical transcatheter aortic valve implantation: a single-centre experience.

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 < 0.001). Unadjusted 30-day mortality rate was higher in TA than in TF patients, albeit this difference was not significant [TA: 6.7%, TF: 4.8%; odds ratio (OR) 1.3 (0.8-2.3); P = 0.216]. The multivariate logistic regression analysis revealed the logistic EuroSCORE and institutional experience, but not the access mode as independent predictors of 30-day mortality. Major access-site complications occurred with a similar frequency in both groups [TA: 9.4%; TF: 9.2%; OR 1.02 (0.68-1.53); P = 0.915]. Unadjusted long-term mortality rate was higher after TA TAVI. After adjustment, the Cox regression analysis revealed similar long-term mortality rates after TF and TA TAVI [hazard ratio 1.1 (0.88-1.36)]. CONCLUSIONS: The increased mortality of patients undergoing TA TAVI is associated with the patient risk profile and the institutional experience but not with the access mode itself.

Bentall procedure after previous aortic valve or complete root replacement: Usefulness of self-assembled aortic valve conduit.

OBJECTIVES: The aim of this study was to evaluate surgical results of complete aortic root replacement using self-assembled valve composite graft in the setting of destroyed aortic annulus after previous valve replacement. METHODS: Aortic root pathology being addressed by complete root replacement was combined with partial or complete absence of annular tissue in 112 consecutive patients. Eighty-eight had undergone a previous replacement of the aortic valve and 24 had undergone root replacement with a valved conduit. Altogether, 31 patients (27.7%) presented with acute endocarditis, which was the indication for surgery in 75% of patients with prior root replacement. In all patients, the root replacement or re-replacement was performed with a self-assembled valved conduit using mechanical (n = 74) or, in patients with an advanced age, biological (n = 38) valve prostheses. RESULTS: In-hospital mortality was 11.6%, including a 30-day mortality of 6.3%. Resternotomy for bleeding was necessary in 5.4% of patients and about one-quarter did not need any blood transfusion. Estimated survival at 1, 5, and 10 years was 84.8% ± 3.4%, 75.7% ± 4.3%, and 57.1% ± 6.5%, respectively. Freedom from any valve-related events at 10 years was 86.2% ± 4.1%. During the follow-up time (mean, 63 ± 47 months), there was only 1 reoperation necessary 9 years after surgery (replacement of deteriorated biological valve prosthesis within the vascular tube leaving the conduit untouched). CONCLUSIONS: A self-assembled composite graft allows safe proximal fixation of the conduit in patients with destroyed aortic annulus, resulting in sufficient proximal anastomosis and a very low incidence of aorta-related reoperations.

Off-Pump Coronary Artery Bypass Grafting and Stroke-Exploratory Analysis of the GOPCABE Trial and Methodological Considerations.

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.

Female sex is not a risk factor for post procedural mortality in coronary bypass surgery in the elderly: A secondary analysis of the GOPCABE trial.

OBJECTIVE: Female sex is considered a significant risk in cardiac surgery and is included in the majority of scores for risk assessment. However, the evidence is controversial and older women undergoing cardiac surgery have not specifically been investigated. We assessed the influence of female sex on surgical risk (30-day mortality) in a secondary analysis of the GOPCABE trial (German Off-Pump Coronary Artery Bypass grafting in the Elderly (GOPCABE) trial, comparing on- to off-pump) and also evaluated its impact on risk prediction from commonly used risk scores. METHODS: We performed logistic regression analyses on the GOPCABE trial population, where patients were randomized to either on- or off-pump CABG. The study was performed in 12 cardiac surgery centers in Germany and analyzed 2394 patients having undergone CABG at age ≥75 years (1187 on-pump, 1207 off-pump). Of the 2394 patients, 755 (32%) were women. The logistic EuroSCORE and the German KCH score were calculated as expected (E) mortality and values were compared to observed (O) 30-day mortality (O/E ratio). RESULTS: There was no difference in mortality or major cardiovascular adverse events after 30 days between men and women for both on- and off-pump CABG (men: on- vs. off-pump OR = 0.90, 95%-CI: [0.63;1.27]; women: on- vs. off-pump OR = 1.07, 95%-CI: [0.62;1.87]). Therefore, groups were combined for further analyses. Both men and women had considerable and similar comorbidities. Expected mortality was significantly higher for women than for men (logistic EuroSCORE: 8.88±6.71% vs. 7.99±6.69%, p = 0.003; KCH score: 4.42±3.97% vs. 3.57±3.65%, p = 0.001). However, observed mortality rates (O) tended to be even lower in women (2.1% vs. 3.0%). The O/E ratio was closer to 1 in men than in women (0.84 vs. 0.47). Excluding female sex from the risk models increased O/E ratio to 0.69. CONCLUSIONS: Female sex is not a risk factor in coronary bypass surgery in the GOPCABE population. The result is the same for on- and off-pump surgery. Since female sex is a component of most risk scores, the findings may identify a potential inaccuracy in current surgical risk assessment, specifically for elderly women. TRIAL REGISTRATION: Clinicaltrials.gov GOPCABE trial No. NCT00719667.

Omission of predilation in balloon-expandable transcatheter aortic valve implantation: retrospective analysis in a large-volume centre.

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<0.001), fluoroscopy times from 9.5±5.7 to 6.2±3.9 minutes (p<0.001) and contrast volume from 131.9±60.8 to 85.4±37.4 ml (p<0.001) without predilation. Intraprocedural CPR was significantly more frequent in the predilation group (5.3% vs. 1.4%, p=0.01). Stroke rate was low at 1.5% and with no detectable difference. Applying VARC-2 definitions, the combined endpoints device success (88.3% vs. 92.4%, p=0.07) and clinical efficacy (88.7% vs. 92.4%, p=0.11) were comparable with or without prior valvuloplasty, while early safety was less frequent with predilation (85.2% vs. 90.2%, p=0.04). At 30 days, all-cause mortality and cardiovascular mortality were 6.8% with predilation vs. 2.9% without predilation (p=0.03) and 5.3% vs. 1.4% (p=0.01). CONCLUSIONS: TAVI without prior valvuloplasty is feasible without apparent adverse impact in patients receiving a balloon-expandable TAVI prosthesis. The omission of predilation is associated with shorter procedure time, less radiation exposure and lower rates of intraprocedural resuscitation.

Closure of a high ventricular septal defect after transcatheter aortic valve implantation with an atrial septal occluder-hybrid treatment for a rare complication.

A patient with porcelain aorta underwent transcatheter aortic valve implantation with a self-expandable prosthesis for severe aortic stenosis. After postdilatation trace paravalvular regurgitation was accepted. 10 weeks later the patient returned with complete heart block and underwent pacemaker implantation. A new heart murmur prompted further investigation. A ventricular septal defect from the left ventricular outflow tract into the right ventricle was detected. It was successfully closed under direct surgical visualization and total cardiopulmonary bypass in an aortic no touch approach. Closure was accomplished with a percutaneous Amplatzer-PFO-occluder. Functional result was excellent.

Preoperative atrial fibrillation and outcome in patients undergoing on-pump or off-pump coronary bypass surgery: lessons learned from the GOPCABE trial.

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.

Acute kidney injury after on-pump or off-pump coronary artery bypass grafting in elderly patients.

BACKGROUND: An exploratory analysis of the German Off Pump Coronary Artery Bypass Grafting in Elderly Patients (GOPCABE) trial was performed to investigate the effect of off-pump coronary artery bypass grafting (CABG) on kidney function after the operation. METHODS: Data on kidney function were available from 1,612 patients, representing 67% of the study population. Preoperative kidney function was graded according to the glomerular filtration rate. Acute kidney injury (AKI) within the first week after the operation was defined and classified according to the Acute Kidney Injury Network (AKIN) criteria. The incidence and severity of AKI was compared between patients operated on on-pump or off-pump. RESULTS: Impaired kidney function was seen in 642 patients (40%), and 19 patients had preexisting end-stage kidney disease. AKI of any severity occurred in half of all patients undergoing CABG, with AKIN stage 1 accounting for most of the cases. The incidence and severity of AKI in patients undergoing on-pump vs off-pump CABG was AKIN stage 1: 298 (37%) vs 329 (42%); AKIN stage 2: 38 (5%) vs 43 (5%); and AKIN stage 3: 44 (6%) vs 44 (6%), which did not differ significantly (p=0.174). New renal replacement therapy was necessary in 3.2% (on-pump) and in 2.7% (off-pump) of all patients. Stratification according to preoperative kidney function yielded comparable frequencies of AKI for on-pump and off-pump CABG. CONCLUSIONS: AKI was common in elderly patients undergoing CABG, but deterioration of kidney function requiring renal replacement therapy was a rare event. Off-pump CABG was not associated with decreased rates or reduced severity of AKI in elderly patients.