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.

Long-term outcomes after aortic root repair using selective sinus replacement.

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.

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.

Selective sinus replacement for aortic root repair in bicuspid aortopathy.

OBJECTIVES: To evaluate the results after selective sinus replacement (SSR) for aortic root remodeling in bicuspid aortopathy. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Augmentation of the posterior mitral leaflet in secondary mitral valve insufficiency, mid-term results.

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.

Clinical outcomes following transapical TAVR with ACURATE neo in the CHANGE neo TA study.

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.

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.

Ascending aorta replacement in patients with coronary ostia localized above the sinotubular junction.

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.

Mitral valve repair for degenerative mitral valve regurgitation.

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.

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.

Predictors of Physical Capacity 6 Months After Implantation of a Full Magnetically Levitated Left Ventricular Assist Device: An Analysis From the ELEVATE Registry.

BACKGROUND: 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. METHODS AND RESULTS: 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) of >300 m (n = 150) or 6MWD of <300 m (n = 44). Patients walking <300 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 of <300 m vs 31% in those walking longer (P < .002). Further, hemoglobin and estimated glomerular filtration rate was lower in those walking <300 m (both P < .01). In multivariable regression analysis, independent predictors of a 6MWD of <300 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). CONCLUSIONS: Six months after HeartMate 3 implantation, 77% of patients walked >300 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.

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.

Transcatheter aortic valve replacement for severe aortic stenosis can improve long-term survival of nonagenarians as compared to an age- and sex-matched general population.

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.

Efficacy of unilateral cerebral perfusion for brain protection in aortic arch surgery.

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.

Multicentre propensity-matched comparison of transcatheter aortic valve implantation using the ACURATE TA/neo self-expanding versus the SAPIEN 3 balloon-expandable prosthesis.

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<0.001 for predilatation and 40.4% versus 11.6%, p<0.001 for post-dilatation), but rapid pacing for implantation was used less frequently (37.1% versus 98.2%, p<0.001). More-than-mild aortic regurgitation at postoperative echocardiography was 12.0% for the ACURATE group and 3.1% for the SAPIEN group, p≤0.001). More-than-mild aortic regurgitation in the ACURATE group differed amongst the centres with 6.0% (3/50) in centre A, 34.1% (29/85) in centre B and 3.4% (6/181) in centre C. Patients in the ACURATE group less frequently had pacemaker implantation compared to the SAPIEN 3 group (11.9% versus 18.5%, p=0.020), 30-day mortality was 4.6% versus 2.1%, respectively, p=0.134, and one-year survival was 83.1% (95% CI: 77.6-87.4) versus 88.8% (95% CI: 84.0-92.2). CONCLUSIONS: In this propensity score analysis, patients treated with the transapical ACURATE or transfemoral ACURATE neo prosthesis less frequently had pacemakers at 30 days but had more aortic regurgitation and lower one-year survival.

PCI and CABG for Treating Stable Coronary Artery Disease: JACC Review Topic of the Week.

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.

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.

Operative and Long-Term Outcomes After Curative Repair of Acute Dissection Involving the Proximal Aorta.

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.