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Aims: The impact of an occluded right coronary artery (RCA) in patients with left main coronary artery disease (LMCAD) undergoing revascularisation is unknown. We compared outcomes for patients with LMCAD randomised to percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) according to the presence of an occluded RCA in the EXCEL trial., Methods and Results: The EXCEL trial randomised 1,905 patients with LMCAD and SYNTAX scores ≤32 to PCI with everolimus-eluting stents versus CABG. Patients were categorised according to whether they had an occluded RCA at baseline, and their outcomes were examined using multivariable Cox proportional hazards regression. The primary endpoint was a composite of death, stroke, or myocardial infarction at three years. Among 1,753 patients with a dominant RCA by core laboratory analysis, the RCA was occluded in 130 (7.4%) at baseline. PCI was attempted in 34 of 65 patients with an occluded RCA (52.3%) and was successful in 27 (79.4% of those attempted; 41.5% of all RCAs recanalised). The RCA was bypassed in 42 of 65 patients with an occluded RCA (64.6%; p=0.0008 versus PCI). The three-year absolute and relative rates of the primary endpoint were similar between PCI and CABG, in patients with or without an occluded RCA (pinteraction=0.92)., Conclusions: In the EXCEL trial, the presence of an occluded RCA at baseline did not confer a worse three-year prognosis in patients undergoing revascularisation for LMCAD and did not affect the relative outcomes of PCI versus CABG in this high-risk patient cohort.

Background: Prompt revascularization is often required in acute coronary syndromes (ACS), whereas stable ischemic heart disease (SIHD) may allow for more measured procedural planning. Whether the acuity of presentation preferentially affects outcomes after coronary artery bypass grafting (CABG) versus percutaneous coronary intervention (PCI) in patients with left main coronary artery disease (LMCAD) is unknown. We investigated whether the acuity of presentation discriminated patients who derived a differential benefit from PCI versus CABG in the randomized Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) trial., Methods: We used multivariable Cox models to assess the interaction between the acuity of presentation, type of revascularization and outcomes in patients with low or intermediate SYNTAX scores enrolled in EXCEL., Results: At baseline, 1151 patients (60.7%) presented with SIHD and 746 patients (39.3%) presented with an ACS. The acuity of presentation was not associated with the primary endpoint of all-cause death, MI, or stroke at 3 years (multivariable adjusted hazard ratio [HR] 0.94; 95% CI 0.70-1.26, P = .64). The primary endpoint rate was similar in patients assigned to PCI versus CABG whether they presented with SIHD (adjusted HR 1.04; 95% CI 0.73-1.48]) or with ACS (HR 0.82; 95% CI 0.54-1.26) (P interaction  = .34)., Conclusions: The acuity of presentation did not predict outcomes in patients with LMCAD undergoing revascularization, nor did it discriminate patients who derive greater event-free survival from PCI versus CABG., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: The randomized EXCEL (Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial reported a similar rate of the 3-year composite primary endpoint of death, myocardial infarction (MI), or stroke in patients with left main coronary artery disease (LMCAD) and site-assessed low or intermediate SYNTAX scores treated with percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG). Whether these results are consistent in high-risk patients with diabetes, who have fared relatively better with CABG in most prior trials, is unknown., Objectives: In this pre-specified subgroup analysis from the EXCEL trial, the authors sought to examine the effect of diabetes in patients with LMCAD treated with PCI versus CABG., Methods: Patients (N = 1,905) with LMCAD and site-assessed low or intermediate CAD complexity (SYNTAX scores ≤32) were randomized 1:1 to PCI with everolimus-eluting stents versus CABG, stratified by the presence of diabetes. The primary endpoint was the rate of a composite of all-cause death, stroke, or MI at 3 years. Outcomes were examined in patients with (n = 554) and without (n = 1,350) diabetes., Results: The 3-year composite primary endpoint was significantly higher in diabetic compared with nondiabetic patients (20.0% vs. 12.9%; p < 0.001). The rate of the 3-year primary endpoint was similar after treatment with PCI and CABG in diabetic patients (20.7% vs. 19.3%, respectively; hazard ratio: 1.03; 95% confidence interval: 0.71 to 1.50; p = 0.87) and nondiabetic patients (12.9% vs. 12.9%, respectively; hazard ratio: 0.98; 95% confidence interval: 0.73 to 1.32; p = 0.89). All-cause death at 3 years occurred in 13.6% of PCI and 9.0% of CABG patients (p = 0.046), although no significant interaction was present between diabetes status and treatment for all-cause death (p = 0.22) or other endpoints, including the 3-year primary endpoint (p = 0.82) or the major secondary endpoints of death, MI, or stroke at 30 days (p = 0.61) or death, MI, stroke, or ischemia-driven revascularization at 3 years (p = 0.65)., Conclusions: In the EXCEL trial, the relative 30-day and 3-year outcomes of PCI with everolimus-eluting stents versus CABG were consistent in diabetic and nondiabetic patients with LMCAD and site-assessed low or intermediate SYNTAX scores.(Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization [EXCEL]; NCT01205776)., (Copyright © 2019. Published by Elsevier Inc.)

Background: The prognostic impact of high-sensitivity C-reactive protein (CRP) levels in patients with left main coronary artery disease (LMCAD) treated with percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) is unknown. We sought to determine the effect of elevated baseline CRP levels on the 3-year outcomes after LMCAD revascularization and to examine whether CRP influenced the relative outcomes of PCI versus CABG., Methods: In the EXCEL trial, patients with LMCAD and Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) scores ≤32 were randomized to PCI versus CABG. The primary composite outcome of death, myocardial infarction (MI), or stroke was analyzed according to baseline CRP levels., Results: Among 999 patients with available CRP levels, median CRP was 3.10 mg/L (interquartile range 1.12-6.40 mg/L). The rate of the primary composite end point of death, MI, or stroke at 3 years steadily increased with greater baseline CRP levels. The adjusted relationship between the 3-year composite rate of death, MI, or stroke and baseline CRP modeled as a continuous log-transformed variable demonstrated steadily increasing event rates with greater CRP levels (adjusted hazard ratio, 1.26, 95% CI 1.10-1.44, P = .0008). Similarly, patients with CRP ≥10 mg/L had a 3-fold higher risk of the 3-year primary end point compared to patients with lower CRP levels (adjusted hazard ratio 2.92, 95% CI 1.88-4.54, P < .0001). The association between an elevated CRP level and the adjusted 3-year risk of the primary composite end point did not differ according to revascularization strategy (P interaction = .75)., Conclusions: In patients with LMCAD undergoing revascularization, elevated baseline CRP levels were strongly associated with subsequent death, MI, and stroke at 3 years, irrespective of the mode of revascularization. Further studies are warranted to determine whether anti-inflammatory therapies may improve the prognosis of high-risk patients with LMCAD following revascularization., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: Internal thoracic artery (ITA) grafts are the most durable conduits available for coronary artery bypass grafting (CABG). However, little is known about long-term angiographic outcomes of ITA grafts used in different configurations and whether sequential or Y grafting compromises patency of the inflow ITA graft., Methods: From January 1972 to August 2016, 60,500 patients underwent primary isolated CABG, of whom 326 received ITA grafts placed in sequential or Y configuration and were studied angiographically (median 4.8 years to first follow-up angiogram). Each sequential or Y segment was studied individually using a mixed-effects longitudinal model with the patient as the random effect., Results: At 15 years, patency of the proximal ITA segment (n = 331) was 99%; of a sequential segment (n = 222), 97%; and of the segment beyond anastomosis of a Y graft (n = 109), 99%. Patency of the Y grafts (n = 109) was 92% at 5 years, 91% at 10 years, and 90% at 15 years. After adjusting for proximal stenosis and graft location, Y grafts were associated with greater occlusion than the inflow segment of ITA grafts (odds ratio; 51, 95% confidence interval, 6.1 to 422; p = 0.003) and of sequential grafts (odds ratio, 12; 95% confidence interval, 1.14 to 120; p = 0.04)., Conclusions: Long-term patency of ITA grafts in sequential or Y configuration is similar qualitatively, but not quantitatively, to the known patency of single ITA-to-left anterior descending grafts. Sequential or Y grafting does not compromise patency of the inflow portion of an ITA graft. Y-graft patency is lower than sequential graft patency but is still better than known patency of saphenous vein grafts., (Copyright © 2019 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Objectives: There is a paucity of data on the effect of baseline lipid-lowering therapy (LLT) in patients undergoing revascularization for left main (LM) coronary artery disease (CAD). We compared outcomes for patients with LMCAD randomized to percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) according to the presence of baseline LLT in the EXCEL trial., Patients and Methods: The EXCEL trial randomized 1905 patients with LMCAD and SYNTAX scores up to 32 to PCI with everolimus-eluting stents versus CABG. Patients were categorized according to whether they were medically treated with LLT at baseline, and their outcomes were examined using multivariable Cox proportional hazards regression. The primary endpoint was a composite of death, stroke, or myocardial infarction at 3 years., Results: Among 1901 patients with known baseline LLT status, 1331 (70.0%) were medically treated with LLT at baseline. There were no significant differences between the PCI and CABG groups in the 3-year rates of the primary endpoint in patients with versus without baseline LLT (Pinteraction=0.62). Among patients with baseline LLT, the 3-year rate of ischemia-driven revascularization was higher after PCI compared with CABG (13.7 vs. 5.3%; adjusted hazard ratio=2.97; 95% confidence interval: 1.95-4.55; P<0.0001), in contrast to patients without baseline LLT (9.8 vs. 12.1%; adjusted hazard ratio=0.79; 95% confidence interval: 0.47-1.33; P=0.39) (Pinteraction=0.0003)., Conclusion: In the EXCEL trial, 3-year major adverse event rates after PCI versus CABG for LMCAD were similar and consistent in patients with and without LLT at baseline; however, revascularization during follow-up was more common after PCI compared with CABG in patients with baseline LLT, but not in those without baseline LLT.

Objectives: The aim of this study was to determine whether high-risk patients with left main coronary artery disease (LMCAD) and prior cerebrovascular disease (CEVD) preferentially benefit from revascularization by percutaneous coronary intervention (PCI) compared with coronary artery bypass grafting (CABG)., Background: Patients with known CEVD requiring revascularization are often referred to PCI rather than CABG. There is a paucity of data regarding the impact of CEVD in patients with LMCAD undergoing revascularization., Methods: In the EXCEL (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial, patients with LMCAD and low or intermediate SYNTAX (Synergy Between PCI with Taxus and Cardiac Surgery) scores were randomized to PCI with everolimus-eluting stents versus CABG. The effects of prior CEVD, defined as prior stroke, transient ischemic attack, or carotid artery disease, on 30-day and 3-year event rates were assessed., Results: Prior CEVD was present in 233 of 1,898 patients (12.3%). These patients were older and had higher rates of comorbidities, including hypertension, diabetes, peripheral vascular disease, anemia, chronic kidney disease, and prior PCI, compared with those without prior CEVD. Patients with prior CEVD had higher rates of stroke at 30 days (2.2% vs. 0.8%; p = 0.05) and 3 years (6.4% vs. 2.2%; p = 0.0003) and higher 3-year rates of the primary endpoint of all-cause death, stroke, or myocardial infarction (25.0% vs. 13.6%; p < 0.0001). The relative effects of PCI versus CABG on the 30-day and 3-year rates of stroke (p interaction  = 0.65 and 0.16, respectively) and the 3-year rates of the primary composite endpoint (p interaction  = 0.14) were consistent in patients with and those without prior CEVD., Conclusions: Patients with LMCAD and prior CEVD compared with those without CEVD have higher rates of stroke and reduced event-free survival after revascularization. Data from the EXCEL trial do not a priori support a preferential role of PCI over CABG in patients with known CEVD., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Limited data exist studying the outcomes of the 2 minimally invasive aortic valve replacement (AVR) strategies-mini-sternotomy (AVR-st) and right anterior thoracotomy (AVR-th). We conducted an indirect meta-analysis to compare the outcomes of these minimally invasive approaches with each other and with conventional AVR (cAVR)., Methods: We Searched Medline, PubMed, Embase, and Web of Science in December 2017 for studies comparing AVR-st, AVR-th, and cAVR. Clinical outcomes were compared between cohorts with inverse weighted random effects modeling. Endpoints studied included hospital mortality, stroke, atrial fibrillation, cardiopulmonary bypass (CPB) time, and length of stay., Results: A total of 19 studies (>10,000 pooled patients) met the inclusion criteria. Mortality (p = 0.06) and stroke (p = 0.15) were comparable between minimally invasive and conventional AVR. CPB times were longer with AVR-th versus cAVR (12.4 minutes [range, 5 to 19]; p < 0.01). In the AVR-th cohort, CPB duration was weakly inversely related to study size (p = 0.06). Atrial fibrillation was much less after AVR-th (odds ratio 0.47 [0.35 to 0.63]; p < 0.001). Hospital stay was significantly lower after minimally invasive surgery (0.8 [0.4 to 1.3] days; p < 0.01). AVR-th patients were dismissed 2.1 (1.6 to 2.7) days earlier than cAVR patients., Conclusions: Minimally invasive approaches to AVR yield excellent outcomes in high-volume centers. They reduce hospital stay and incidence of postoperative atrial fibrillation, and therefore should be considered in patients undergoing AVR. The operative approach should be selected according to surgeon's technical expertise and what is best for specific patient profile, however., (Copyright © 2018 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Saphenous vein was the conduit used in the first series of coronary artery bypass grafting (CABG), and, with the exception of surgical revascularization of the left anterior descending artery, it remains the most commonly used bypass conduit. However, its durability and longevity are not ideal. Arterial grafts have better patency than saphenous vein grafts and therefore should be preferred over them. However, in certain situations, like grafting right coronary arteries with lesser degree of proximal stenosis and higher competitive flow, or in certain patient populations, like those at very high risk of wound infections and octogenarians, arterial grafting may not be the best option and saphenous vein grafting should be considered instead., Competing Interests: Conflict of interestDr. Joseph F. Sabik, III: North American principal investigator for the Abbott Laboratories–sponsored left main coronary disease randomized trial (EXCEL). Society of Thoracic Surgeons board of directors. Scientific advisory board of Medtronic. Other authors: none., (© Indian Association of Cardiovascular-Thoracic Surgeons 2018.)

Aims: We sought to compare clinical outcomes and procedural characteristics with transradial access (TRA) versus transfemoral access (TFA) in patients who were treated with PCI for left main (LM) coronary artery disease., Methods and Results: The EXCEL trial was a prospective, international, open-label, multicentre trial that randomised 1,905 patients with LM disease and SYNTAX scores ≤32 to PCI with everolimus-eluting stents versus coronary artery bypass grafting. The present analysis cohort consisted of 931 patients undergoing PCI with TRA or TFA, but not both. The primary endpoint was a composite of death, myocardial infarction (MI), or stroke at three years. Multivariable Cox proportional hazards regression was used to adjust for differences in baseline covariates. PCI in EXCEL was performed exclusively with TRA in 248 (26.6%) patients and with TFA in 683 (73.4%) patients. TRA patients were younger and less likely to have hypertension and chronic kidney disease. The mean number of vessels and lesions treated was higher in TFA patients, although the SYNTAX score was similar in both groups. Patients undergoing TRA and TFA had similar 30-day rates of TIMI major or minor bleeding (2.4% versus 3.8%, respectively, p=0.30). At three years, TRA and TFA patients had similar rates of the primary endpoint (15.7% versus 14.8%, adjusted HR 1.11, 95% CI: 0.73-1.69, p=0.64), as well as the individual rates of death, MI, stroke, ischaemia-driven revascularisation and stent thrombosis., Conclusions: In the EXCEL trial, PCI of LM disease with TRA was associated with comparable early and late clinical outcomes to TFA.

Background: Distal left main (LM) coronary artery bifurcation disease increases percutaneous coronary intervention (PCI) procedural complexity and is associated with worse outcomes than isolated ostial/shaft disease. The optimal treatment strategy for distal LM disease is undetermined. We sought to determine whether outcomes after PCI of LM distal bifurcation lesions are influenced by treatment with a provisional 1-stent versus planned 2-stent technique, and if so, whether such differences are conditioned by the complexity of the LM bifurcation lesion., Methods and Results: The clinical and angiographic characteristics, procedural methods and outcomes, and clinical events through 3-year follow-up were compared in patients undergoing distal LM PCI with a 1-stent provisional versus planned 2-stent technique in the EXCEL trial (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization). Among 529 patients undergoing planned distal LM PCI, 344 (65.0%) and 185 (35.0%) were treated with intended 1-stent provisional and planned 2-stent techniques, respectively. The primary composite end point rate of death, myocardial infarction, or stroke at 3 years was significantly lower in patients treated with the provisional 1-stent versus planned 2-stent method (14.1% versus 20.7%; adjusted hazard ratio, 0.55; 95% CI, 0.35-0.88; P=0.01), driven by differences in cardiovascular death (3.3% versus 8.3%, P=0.01) and myocardial infarction (7.7% versus 12.8%, P=0.06). The 3-year rate of ischemia-driven revascularization of the LM complex was also lower in the provisional group (7.2% versus 16.3%, P=0.001). In 342 patients with distal LM bifurcation disease that did not involve both major side branch vessels, the 3-year primary end point was lower with a provisional 1-stent versus planned 2-stent technique (13.8% versus 23.3%, P=0.04), whereas no significant difference was present in 182 patients with distal LM bifurcation disease that did involve both side branch vessels (14.3% versus 19.2%, P=0.36)., Conclusions: Among patients with distal LM bifurcation disease in the EXCEL trial randomized to PCI, 3-year adverse outcomes were worse with planned 2-stent treatment compared with a provisional 1-stent approach, a difference that was confined to patients without major involvement of both LM side branch vessels., Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01205776.

Objective: To assess the safety and benefits of new techniques and technologies such as single-dose (del Nido) cardioplegia and suture fasteners (COR-KNOT) in patients undergoing mini-thoracotomy for degenerative mitral valve repair (MVR)., Methods: From 2009 to 2016, 252 patients underwent primary isolated degenerative MVR by mini-thoracotomy by a single surgeon. Del Nido cardioplegia was used in 153 patients (61%) and COR-KNOT in 168 (67%). Patient outcomes were compared using propensity-matching separately for del Nido versus Buckberg cardioplegia and COR-KNOT versus knot-pusher., Results: There were no operative deaths and 99.2% of the patients had none/trivial mitral regurgitation at discharge. In patients receiving del Nido or Buckberg cardioplegia, occurrence of adverse events was similar. However, aortic cross clamp (AoCC; 54.2 ± 15.7 vs 64 ± 15.8 min; P < 0.0001) and operative room (OR; 308 ± 42.1 vs 336 ± 63 min; P < 0.001) times were shorter with del Nido cardioplegia. In patients receiving COR-KNOT versus knot-pusher, occurrence of adverse events was similar. However, AoCC (54.1 ± 15.2 vs 66.1 ± 15.9 min; P < 0.0001) and OR (311 ± 43.6 vs 336 ± 65.4 min; P < 0.0001) times were shorter with COR-KNOT. Results were similar after matching for both, del Nido versus Buckberg cardioplegia and COR-KNOT versus knot-pusher., Conclusion: New techniques and technologies, such as del Nido cardioplegia and COR-KNOT, decrease AoCC and OR times without compromising patient safety., (© 2018 Wiley Periodicals, Inc.)

Objectives: The study objectives were to evaluate the safety, effectiveness, and hemodynamic performance of a new stented bovine pericardial aortic valve., Methods: This trial enrolled patients with symptomatic moderate or severe aortic stenosis or chronic, severe aortic regurgitation. We assessed death, valve-related adverse events, functional recovery, and hemodynamic performance at discharge, 3 to 6 months, and 1 year, as required by the US Food and Drug Administration for regulatory approval. The primary analysis compared late linearized rates of valve-related adverse events after implantation with Food and Drug Administration-specified objective performance criteria to determine whether the adverse event rates associated with the valve are within acceptable limits. Adverse events included thromboembolism, thrombosis, all and major hemorrhage, all and major paravalvular leak, and endocarditis., Results: The primary analysis included 864 patients who received an implant and 904.1 valve-years of follow-up. A total of 577 patients completed the 1-year evaluation. The primary end point was met for death, thromboembolism, thrombosis, all and major paravalvular leak, and endocarditis, but not for all and major hemorrhage. At 1 year, freedom from all death and from valve-related death was 96.4% and 99.7%, respectively. From baseline to 1 year, New York Heart Association class changed as follows: I, 10.8% to 73.7%; II, 48.9% to 22.6%; III, 38.0% to 3.5%; and IV, 2.3% to 0.2%. Effective orifice area increased from 0.9 ± 0.5 to 1.5 ± 0.4 (P < .0001), and mean aortic gradient decreased from 42.7 ± 16.5 to 12.5 ± 4.3 (P < .0001)., Conclusions: This analysis of a new stented bovine pericardial aortic valve demonstrated low overall mortality and valve-related adverse events, and hemodynamic performance comparable to that of other surgical aortic valves., (Copyright © 2018 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Background: The optimal revascularization strategy for patients with left main coronary artery disease (LMCAD) and chronic kidney disease (CKD) remains unclear., Objectives: This study investigated the comparative effectiveness of percutaneous coronary intervention (PCI) versus coronary artery bypass graft (CABG) surgery in patients with LMCAD and low or intermediate anatomical complexity according to baseline renal function from the multicenter randomized EXCEL (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial., Methods: CKD was defined as an estimated glomerular filtration rate <60 ml/min/1.73 m 2 using the CKD Epidemiology Collaboration equation. Acute renal failure (ARF) was defined as a serum creatinine increase ≥5.0 mg/dl from baseline or a new requirement for dialysis. The primary composite endpoint was the composite of death, myocardial infarction (MI), or stroke at 3-year follow-up., Results: CKD was present in 361 of 1,869 randomized patients (19.3%) in whom baseline estimated glomerular filtration rate was available. Patients with CKD had higher 3-year rates of the primary endpoint compared with those without CKD (20.8% vs. 13.5%; hazard ratio [HR]: 1.60; 95% confidence interval [CI]: 1.22 to 2.09; p = 0.0005). ARF within 30 days occurred more commonly in patients with compared with those without CKD (5.0% vs. 0.8%; p < 0.0001), and was strongly associated with the 3-year risk of death, stroke, or MI (50.7% vs. 14.4%; HR: 4.59; 95% CI: 2.73 to 7.73; p < 0.0001). ARF occurred less commonly after revascularization with PCI compared with CABG both in patients with CKD (2.3% vs. 7.7%; HR: 0.28; 95% CI: 0.09 to 0.87) and in those without CKD (0.3% vs. 1.3%; HR: 0.20; 95% CI: 0.04 to 0.90; p interaction  = 0.71). There were no significant differences in the rates of the primary composite endpoint after PCI and CABG in patients with CKD (23.4% vs. 18.1%; HR: 1.25; 95% CI: 0.79 to 1.98) and without CKD (13.4% vs. 13.5%; HR: 0.97; 95% CI: 0.73 to 1.27; p interaction  = 0.38)., Conclusions: Patients with CKD undergoing revascularization for LMCAD in the EXCEL trial had increased rates of ARF and reduced event-free survival. ARF occurred less frequently after PCI compared with CABG. There were no significant differences between PCI and CABG in terms of death, stroke, or MI at 3 years in patients with and without CKD. (EXCEL Clinical Trial [EXCEL]; NCT01205776)., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Elevated B-type natriuretic peptide (BNP) is reflective of impaired cardiac function and is associated with worse prognosis among patients with coronary artery disease (CAD). We sought to assess the association between baseline BNP, adverse outcomes, and the relative efficacy of percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG) in patients with left main CAD., Methods: The EXCEL trial (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) randomized patients with left main CAD and low or intermediate SYNTAX scores (Synergy Between PCI With TAXUS and Cardiac Surgery) to PCI with everolimus-eluting stents versus CABG. The primary end point was the composite of all-cause death, myocardial infarction, or stroke. We used multivariable Cox proportional hazards regression to assess the associations between normal versus elevated BNP (≥100 pg/mL), randomized treatment, and the 3-year risk of adverse events., Results: BNP at baseline was elevated in 410 of 1037 (39.5%) patients enrolled in EXCEL. Patients with elevated BNP levels were older and more frequently had additional cardiovascular risk factors and lower left ventricular ejection fraction than those with normal BNP, but had similar SYNTAX scores. Patients with elevated BNP had significantly higher 3-year rates of the primary end point (18.6% versus 11.7%; adjusted hazard ratio [HR], 1.62; 95% confidence interval [CI], 1.16-2.28; P=0.005) and higher mortality (11.5% versus 3.9%; adjusted HR, 2.49; 95% CI, 1.48-4.19; P=0.0006), both from cardiovascular and noncardiovascular causes. In contrast, there were no significant differences in the risks of myocardial infarction, stroke, ischemia-driven revascularization, stent thrombosis, graft occlusion, or major bleeding. A significant interaction ( P interaction =0.03) was present between elevated versus normal BNP and treatment with PCI versus CABG for the adjusted risk of the primary composite end point at 3 years among patients with elevated BNP (adjusted HR for PCI versus CABG, 1.54; 95% CI, 0.96-2.47) versus normal BNP (adjusted HR, 0.74; 95% CI, 0.46-1.20). This interaction was stronger when log(BNP) was modeled as a continuous variable ( P interaction =0.002)., Conclusions: In the EXCEL trial, elevated baseline BNP levels in patients with left main CAD undergoing revascularization were independently associated with long-term mortality but not nonfatal adverse ischemic or bleeding events. The relative long-term outcomes after PCI versus CABG for revascularization of left main CAD may be conditioned by the baseline BNP level., Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01205776.

Background: Coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) are used for coronary revascularization in patients with multivessel and left main coronary artery disease. Stroke is among the most feared complications of revascularization. Due to its infrequency, studies with large numbers of patients are required to detect differences in stroke rates between CABG and PCI., Objectives: This study sought to compare rates of stroke after CABG and PCI and the impact of procedural stroke on long-term mortality., Methods: We performed a collaborative individual patient-data pooled analysis of 11 randomized clinical trials comparing CABG with PCI using stents; ERACI II (Argentine Randomized Study: Coronary Angioplasty With Stenting Versus Coronary Bypass Surgery in Patients With Multiple Vessel Disease) (n = 450), ARTS (Arterial Revascularization Therapy Study) (n = 1,205), MASS II (Medicine, Angioplasty, or Surgery Study) (n = 408), SoS (Stent or Surgery) trial (n = 988), SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) trial (n = 1,800), PRECOMBAT (Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease) trial (n = 600), FREEDOM (Comparison of Two Treatments for Multivessel Coronary Artery Disease in Individuals With Diabetes) trial (n = 1,900), VA CARDS (Coronary Artery Revascularization in Diabetes) (n = 198), BEST (Bypass Surgery Versus Everolimus-Eluting Stent Implantation for Multivessel Coronary Artery Disease) (n = 880), NOBLE (Percutaneous Coronary Angioplasty Versus Coronary Artery Bypass Grafting in Treatment of Unprotected Left Main Stenosis) trial (n = 1,184), and EXCEL (Evaluation of Xience Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial (n = 1,905). The 30-day and 5-year stroke rates were compared between CABG and PCI using a random effects Cox proportional hazards model, stratified by trial. The impact of stroke on 5-year mortality was explored., Results: The analysis included 11,518 patients randomly assigned to PCI (n = 5,753) or CABG (n = 5,765) with a mean follow-up of 3.8 ± 1.4 years during which a total of 293 strokes occurred. At 30 days, the rate of stroke was 0.4% after PCI and 1.1% after CABG (hazard ratio [HR]: 0.33; 95% confidence interval [CI]: 0.20 to 0.53; p < 0.001). At 5-year follow-up, stroke remained significantly lower after PCI than after CABG (2.6% vs. 3.2%; HR: 0.77; 95% CI: 0.61 to 0.97; p = 0.027). Rates of stroke between 31 days and 5 years were comparable: 2.2% after PCI versus 2.1% after CABG (HR: 1.05; 95% CI: 0.80 to 1.38; p = 0.72). No significant interactions between treatment and baseline clinical or angiographic variables for the 5-year rate of stroke were present, except for diabetic patients (PCI: 2.6% vs. CABG: 4.9%) and nondiabetic patients (PCI: 2.6% vs. CABG: 2.4%) (p for interaction = 0.004). Patients who experienced a stroke within 30 days of the procedure had significantly higher 5-year mortality versus those without a stroke, both after PCI (45.7% vs. 11.1%, p < 0.001) and CABG (41.5% vs. 8.9%, p < 0.001)., Conclusions: This individual patient-data pooled analysis demonstrates that 5-year stroke rates are significantly lower after PCI compared with CABG, driven by a reduced risk of stroke in the 30-day post-procedural period but a similar risk of stroke between 31 days and 5 years. The greater risk of stroke after CABG compared with PCI was confined to patients with multivessel disease and diabetes. Five-year mortality was markedly higher for patients experiencing a stroke within 30 days after revascularization., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The authors sought to determine the extent to which the site of the left main coronary artery (LM) lesion (distal bifurcation versus ostial/shaft) influences the outcomes of revascularization with percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG)., Background: Among 1,905 patients with LM disease and site-assessed SYNTAX scores of <32 randomized in the EXCEL (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial, revascularization with PCI and CABG resulted in similar rates of the composite primary endpoint of death, myocardial infarction (MI), or stroke at 3 years., Methods: Outcomes from the randomized EXCEL trial were analyzed according to the presence of angiographic core laboratory-determined diameter stenosis ≥50% involving the distal LM bifurcation (n = 1,559; 84.2%) versus disease isolated to the LM ostium or shaft (n = 293; 15.8%)., Results: At 3 years, there were no significant differences between PCI and CABG for the primary composite endpoint of death, MI, or stroke for treatment of both distal LM bifurcation disease (15.6% vs. 14.9%, odds ratio [OR]: 1.08, 95% confidence interval [CI]: 0.81 to 1.42; p = 0.61) and isolated LM ostial/shaft disease (12.4% vs. 13.5%, OR: 0.90, 95% CI: 0.45 to 1.81; p = 0.77) (p interaction  = 0.65). However, at 3 years, ischemia-driven revascularization occurred more frequently after PCI than CABG in patients with LM distal bifurcation disease (13.0% vs. 7.2%, OR: 2.00, 95% CI: 1.41 to 2.85; p = 0.0001), but were not significantly different in patients with disease only at the LM ostium or shaft (9.7% vs. 8.4%, OR: 1.18, 95% CI: 0.52 to 2.69; p = 0.68) (p interaction  = 0.25)., Conclusions: In the EXCEL trial, PCI and CABG resulted in comparable rates of death, MI, or stroke at 3 years for treatment of LM disease, including those with distal LM bifurcation disease. Repeat revascularization rates during follow-up after PCI compared with CABG were greater for lesions in the distal LM bifurcation but were similar for disease isolated to the LM ostium or shaft., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of the present study was to assess outcomes after coronary artery bypass grafting surgery (CABG) and percutaneous coronary intervention (PCI) according to sex in a large randomized trial of patients with unprotected left main disease., Background: In the SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) trial, sex had a significant interaction effect with revascularization strategy, and women had an overall higher mortality when treated with PCI than CABG., Methods: The EXCEL (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial was a multinational randomized trial that compared PCI with everolimus-eluting stents and CABG in patients with unprotected left main disease. The primary endpoint was the composite of all-cause death, myocardial infarction, or stroke at 3 years., Results: Of 1,905 patients randomized, 1,464 (76.9%) were men and 441 (23.1%) were women. Compared with men, women were older; had higher prevalence rates of hypertension, hyperlipidemia, and diabetes; and were less commonly smokers but had lower coronary anatomic burden and complexity (mean SYNTAX score 24.2 vs. 27.2, p < 0.001). By multivariate analysis, sex was not independently associated with either the primary endpoint (hazard ratio [HR]: 1.10; 95% confidence interval [CI]: 0.82 to 1.48; p = 0.53) or all-cause death (HR: 1.39; 95% CI: 0.92 to 2.10; p = 0.12) at 3 years. At 30 days, all-cause death, myocardial infarction, or stroke had occurred in 8.9% of woman treated with PCI, 6.2% of women treated with CABG, 3.6% of men treated with PCI, and 8.4% of men treated with CABG (p for interaction = 0.003). The 3-year rate of the composite primary endpoint was 19.7% in women treated with PCI, 14.6% in women treated with CABG, 13.8% in men treated with PCI, and 14.7% in men treated with CABG (p for interaction = 0.06). These differences were driven by higher periprocedural rates of myocardial infarction in women after PCI and in men after CABG., Conclusions: In patients with unprotected left main disease in the EXCEL trial, sex was not an independent predictor of adverse outcomes after revascularization. However, women undergoing PCI had a trend toward worse outcomes, a finding related to associated comorbidities and increased periprocedural complications. Further studies are required to determine the optimal revascularization modality in women with complex coronary artery disease., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Numerous randomised trials have compared coronary artery bypass grafting (CABG) with percutaneous coronary intervention (PCI) for patients with coronary artery disease. However, no studies have been powered to detect a difference in mortality between the revascularisation strategies., Methods: We did a systematic review up to July 19, 2017, to identify randomised clinical trials comparing CABG with PCI using stents. Eligible studies included patients with multivessel or left main coronary artery disease who did not present with acute myocardial infarction, did PCI with stents (bare-metal or drug-eluting), and had more than 1 year of follow-up for all-cause mortality. In a collaborative, pooled analysis of individual patient data from the identified trials, we estimated all-cause mortality up to 5 years using Kaplan-Meier analyses and compared PCI with CABG using a random-effects Cox proportional-hazards model stratified by trial. Consistency of treatment effect was explored in subgroup analyses, with subgroups defined according to baseline clinical and anatomical characteristics., Findings: We included 11 randomised trials involving 11 518 patients selected by heart teams who were assigned to PCI (n=5753) or to CABG (n=5765). 976 patients died over a mean follow-up of 3·8 years (SD 1·4). Mean Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) score was 26·0 (SD 9·5), with 1798 (22·1%) of 8138 patients having a SYNTAX score of 33 or higher. 5 year all-cause mortality was 11·2% after PCI and 9·2% after CABG (hazard ratio [HR] 1·20, 95% CI 1·06-1·37; p=0·0038). 5 year all-cause mortality was significantly different between the interventions in patients with multivessel disease (11·5% after PCI vs 8·9% after CABG; HR 1·28, 95% CI 1·09-1·49; p=0·0019), including in those with diabetes (15·5% vs 10·0%; 1·48, 1·19-1·84; p=0·0004), but not in those without diabetes (8·7% vs 8·0%; 1·08, 0·86-1·36; p=0·49). SYNTAX score had a significant effect on the difference between the interventions in multivessel disease. 5 year all-cause mortality was similar between the interventions in patients with left main disease (10·7% after PCI vs 10·5% after CABG; 1·07, 0·87-1·33; p=0·52), regardless of diabetes status and SYNTAX score., Interpretation: CABG had a mortality benefit over PCI in patients with multivessel disease, particularly those with diabetes and higher coronary complexity. No benefit for CABG over PCI was seen in patients with left main disease. Longer follow-up is needed to better define mortality differences between the revascularisation strategies., Funding: None., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

Background: It remains controversial whether grafting moderately stenosed coronary arteries (MSCAs) influences native-vessel disease progression and whether grafting may protect against late myocardial ischemia., Methods: From 1972 to 2011, 55,567 patients underwent primary isolated coronary artery bypass grafting (CABG); 1,902 had a single coronary artery with angiographically moderate (50% to 69%) stenosis and ≥1 postoperative angiogram. Disease progression was studied in 489 nongrafted, 371 internal thoracic artery (ITA)-grafted, and 957 saphenous vein (SV)-grafted MSCAs, as well as patency of 376 ITA and 1,016 SV grafts to these MSCAs., Results: At 1, 5, 10, and 15 years, native-vessel disease progressed from moderate to severe stenosis/occlusion in 32%, 52%, 66%, and 72% of nongrafted MSCAs; 55%, 73%, 84%, and 87% of ITA-grafted MSCAs; and 67%, 82%, 90%, and 92% of SV-grafted MSCAs. After adjusting for patient characteristics, MSCA disease progressed 3.6 times faster with ITA and 10 times faster with SV grafting compared with nongrafting. At these same time points, occlusion of ITA grafts to MSCAs was 8%, 9%, 11%, and 15% and for SV grafts, 13%, 32%, 46%, and 56%; protection from myocardial ischemia by ITA-grafted versus nongrafted MSCAs was 29%, 47%, 59%, and 61%., Conclusions: Most MSCAs progress to severe stenosis or occlusion in the long term. Progression is faster in grafted than nongrafted MSCAs, more so with SV than ITA grafts. However, ITA grafts to such arteries have excellent patency, providing long-term protection from myocardial ischemia. Therefore, ITA grafting of MSCAs should be considered., (Copyright © 2018 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: To determine the value of aortic valve repair rather than replacement for valve dysfunction, we assessed late outcomes of various repair techniques in the contemporary era., Methods: From January 2001 to January 2011, aortic valve repair was planned in 1,124 patients. Techniques involved commissural figure-of-8 suspension sutures (n = 63 [6.2%]), cusp repair with commissuroplasty (n = 481 [48%]), debridement (n = 174 [17%]), free-margin plication (n = 271 [27%]) or resection (n = 75) or both, or annulus repair with resuspension (n = 230 [23%]), root reimplantation (n = 252 [25%]), or remodeling (n = 35 [3.5%])., Results: Planned repair was aborted for replacement in 115 patients (10%); risk factors included greater severity of aortic regurgitation (AR; p = 0.0002) and valve calcification (p < 0.0001). In-hospital outcomes for the remaining 1,009 patients included death (12 [1.2%]), stroke (13 [1.3%]), and reoperation for valve dysfunction (14 [1.4%]). Freedom from aortic valve reoperation at 1, 5, and 10 years was 97%, 93%, and 90%, respectively. Figure-of-8 suspension sutures, valve resuspension, and root repair and replacement were least likely to require reoperation; cusp repair with commissural sutures, plication, and commissuroplasty was most likely (p < 0.05). Survival at 1, 5, and 10 years was 96%, 92%, and 83%. Immediate postoperative AR grade was none-mild (94%), moderate (5%), and severe (1%). At 10 years after repair, AR grade was none (20%), mild (33%), moderate (26%), and severe (21%). Patients undergoing root procedures were less likely to have higher-grade postoperative AR (p < 0.0001)., Conclusions: Valve repair is effective and durable for treating aortic valve dysfunction. Greater severity of AR preoperatively is associated with higher likelihood of repair failure. Commissural figure-of-8 suspension sutures and repair with annular support have the best long-term durability., (Copyright © 2018 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: There is limited information on the incidence and prognostic impact of new-onset atrial fibrillation (NOAF) following percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) for left main coronary artery disease (LMCAD)., Objectives: This study sought to determine the incidence of NOAF following PCI and CABG for LMCAD and its effect on 3-year cardiovascular outcomes., Methods: In the EXCEL (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial, 1,905 patients with LMCAD and low or intermediate SYNTAX scores were randomized to PCI with everolimus-eluting stents versus CABG. Outcomes were analyzed according to the development of NOAF during the initial hospitalization following revascularization., Results: Among 1,812 patients without atrial fibrillation on presentation, NOAF developed at a mean of 2.7 ± 2.5 days after revascularization in 162 patients (8.9%), including 161 of 893 (18.0%) CABG-treated patients and 1 of 919 (0.1%) PCI-treated patients (p < 0.0001). Older age, greater body mass index, and reduced left ventricular ejection fraction were independent predictors of NOAF in patients undergoing CABG. Patients with versus without NOAF had a significantly longer duration of hospitalization, were more likely to be discharged on anticoagulant therapy, and had an increased 30-day rate of Thrombolysis In Myocardial Infarction major or minor bleeding (14.2% vs. 5.5%; p < 0.0001). By multivariable analysis, NOAF after CABG was an independent predictor of 3-year stroke (6.6% vs. 2.4%; adjusted hazard ratio [HR]: 4.19; 95% confidence interval [CI]: 1.74 to 10.11; p = 0.001), death (11.4% vs. 4.3%; adjusted HR: 3.02; 95% CI: 1.60 to 5.70; p = 0.0006), and the primary composite endpoint of death, MI, or stroke (22.6% vs. 12.8%; adjusted HR: 2.13; 95% CI: 1.39 to 3.25; p = 0.0004)., Conclusions: In patients with LMCAD undergoing revascularization in the EXCEL trial, NOAF was common after CABG but extremely rare after PCI. The development of NOAF was strongly associated with subsequent death and stroke in CABG-treated patients. Further studies are warranted to determine whether prophylactic strategies to prevent or treat atrial fibrillation may improve prognosis in patients with LMCAD who are undergoing CABG. (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization [EXCEL]; NCT01205776)., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Preoperative anemia, defined by hemoglobin level, is associated with elevated risk after cardiac operation. Better understanding of anemia requires characterization beyond this. This investigation focuses on red cell size and its association with patient characteristics and outcomes after cardiac operation., Methods: From January 2010 to January 2014, 10,589 patients underwent elective cardiac operations at Cleveland Clinic. Anemia was characterized as normocytic, microcytic, or macrocytic based on mean corpuscular volume (MCV). Models for hospital complications were developed using multivariable logistic regression. Other outcomes were postoperative transfusion and intensive care unit (ICU) and postoperative hospital lengths of stay., Results: A total of 2,715 patients (26%) were anemic. Of these, 2,365 (87%) had normocytic, 219 (8.1%) microcytic, and 131 (4.8%) macrocytic anemia. Non-anemic patients (n = 2,041, 26%) received transfusions compared with 1,553 (66%) normocytic, 148 (68%) microcytic, and 97 (74%) macrocytic anemia patients. Patients with normocytic or macrocytic anemia had more renal failure (normocytic: odds ratio (OR) 1.9, macrocytic: OR 3.5), other complications (normocytic: OR 1.3, macrocytic: OR 2.2) and death (normocytic: OR 2.0, macrocytic: OR 6.2) than non-anemic patients; patients with microcytic anemia had fewer reoperations (OR 0.35) and less postoperative atrial fibrillation (OR 0.50). Anemic patients experienced longer ICU (27 versus 48 hours, p < 0.001) and postoperative hospital (6.1 versus 7.4 days, p < 0.001) length of stay than non-anemic patients., Conclusions: Cardiac surgical patients are often anemic. Demographic characteristics, comorbidities, and outcomes are dissimilar according to red cell size. Patients with microcytic anemia had the lowest hemoglobin levels, yet the best clinical outcomes among anemic patients. MCV from the standard complete blood count adds additional information beyond hemoglobin for targeted intervention., (Copyright © 2018 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Objective: To compare mitral valve repair (MVRepair) and mitral valve replacement (MVReplace) trends in the Veterans Affairs (VA) Surgical Quality Improvement Program., Methods: Trends were compared by bivariate analyses, followed by backward stepwise selection and multivariable logistic modeling to determine the effect of preoperative comorbidities and facility-level factors on MVRepair (vs MVReplace) rate. A subgroup analysis focused on patients who underwent elective surgery for isolated primary degenerative mitral regurgitation. Propensity matching was done in the overall and primary degenerative cohorts., Results: From October 2000 to October 2013, 4165 veterans underwent MVRepair (n = 2408) or MVReplace (n = 1757) for MV disease of any cause at 40 VA medical centers (procedural volume, 0-29/y; median 7/y). The MVRepair percentage increased from 48% in 2001 to 63% in 2013 (P < .001). MVRepair rates varied widely among centers; center volume explained only 19% of this variation after adjustment for case mix (R 2  = 0.19, P = .005). Unadjusted 30-day and 1-year mortality rates were lower after MVRepair than after MVReplace (3.5% vs 4.8%, P = .04; 9.8% vs 12.1%, P = .02). Among the propensity-matched patients (n = 2520), 30-day and 1-year mortality were similar after MVRepair and MVReplace. In the propensity-matched primary degenerative subgroup (n = 664), unadjusted long-term mortality for up to 10 years postoperatively was lower after MVRepair (28% vs 37%, P = .003), as was risk-adjusted long-term mortality (hazard ratio, 0.78; 95% confidence interval, 0.61-1.01)., Conclusions: In the VA Health System, mortality after MV operations is low. Despite the survival advantage associated with MV repair in primary mitral regurgitation, repair is infrequent at some centers, representing an opportunity for quality improvement., (Copyright © 2017 The American Association for Thoracic Surgery. All rights reserved.)

Background: The purpose of this study was to determine in patients with diabetes mellitus whether single internal thoracic artery (SITA) plus radial artery (RA) grafting yields outcomes similar to those of bilateral internal thoracic artery (BITA) grafting., Methods: From January 1994 to January 2011, 1,325 diabetic patients underwent primary isolated coronary artery bypass graft surgery with either (1) SITA plus RA with or without saphenous vein (SV) grafts (n = 965) or (2) BITA with or without SV grafts (n = 360); an internal thoracic artery was used in all patients to graft the left anterior descending coronary artery. Endpoints were in-hospital outcomes and time-related mortality. Median follow-up was 7.4 years, with a total follow-up of 9,162 patient-years. Propensity score matching was performed to identify 282 well-matched pairs for adjusted comparisons., Results: Unadjusted in-hospital mortality was 0.52% for SITA plus RA with or without SV grafts and 0.28% for BITA with or without SV grafts, and prevalence of deep sternal wound infection was 3.2% and 1.7%, respectively. Unadjusted survival at 1, 5, 10, and 14 years was 97%, 88%, 68%, and 51% for SITA plus RA with or without SV grafts, and 97%, 95%, 80%, and 66% for BITA with or without SV grafts, respectively. Among propensity-matched patients, in-hospital mortality (0.35% versus 0.35%) and prevalence of deep sternal wound infection (1.4% versus 1.4%) were similar (p > 0.9) in the two groups, as was 1-, 5-, 10-, and 14-year survival: 97%, 90%, 70%, and 58% for SITA plus RA with or without SV grafting versus 97%, 93%, 79%, and 64% for BITA with or without SV grafting, respectively (early p = 0.8, late p = 0.2)., Conclusions: For diabetic patients, SITA plus RA with or without SV grafting and BITA with or without SV grafting yield similar in-hospital outcomes and long-term survival after coronary artery bypass graft surgery. Therefore, both SITA plus RA and BITA plus SV grafting should be considered for these patients., (Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Class I evidence supporting a threshold for transfusion in the cardiac surgical setting is scarce. We randomly allocated patients to a transfusion hematocrit trigger of 24% versus 28% to compare morbidity, mortality, and resource use., Methods: From March 2007 to August 2014, two centers randomly assigned 722 adults undergoing coronary artery bypass graft surgery or valve procedures to a 24% hematocrit trigger (n = 363, low group) or 28% trigger (n = 354, high group). One unit of red blood cells was transfused if the hematocrit fell below the designated threshold. The primary endpoint was a composite of postoperative morbidities and mortality. Treatment effect was primarily assessed using an average relative effect generalized estimating equation model., Results: At the second planned interim analysis, the a priori futility boundary was crossed, and the study was stopped. There was no detected treatment effect on the composite outcome (average relative effect odds ratio, low versus high, 0.86, 95% confidence interval: 0.29 to 2.54, p = 0.71). However, the low group received fewer red blood cell transfusions than the high group (54% versus 75%, p < 0.001), mostly administered in the operating room (low group, 112 [31%]; high group, 208 [59%]), followed by intensive care unit (low, 105 [31%]; high, 115 [34%]) and floor (low, 41 [12%]; high, 42 [13%]). The low group was exposed to lower hematocrits: median before transfusion, 22% (Q1 = 21%, Q3 = 23%) versus 24% (Q1 = 22%, Q3 = 25%)., Conclusions: Negative exposures differed between treatment groups, with lower hematocrit in the 24% trigger group and more red blood cells used in the 28% group, but adverse outcomes did not differ. Because red blood cell use was less with a 24% trigger without adverse effects, our randomized trial results support aggressive blood conservation efforts in cardiac surgery., (Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: The Society of Thoracic Surgeons (STS) surveyed cardiothoracic surgeon participants in its Adult Cardiac Surgery Database (ACSD) to learn the extent of surgeon involvement in transcatheter aortic valve replacement (TAVR) procedures., Methods: An electronic survey was delivered to 2,594 surgeons in June 2016. When the survey closed 2 weeks later, 487 completed surveys had been submitted for a response rate of 18.8%., Results: Among the 487 participants in the ACSD who responded to the survey, 410 (84.2%) reported that TAVR was performed at their institutions. Approximately three-quarters reported that they performed TAVR procedures as part of a heart team (77.5%; 313 of 404), cardiologists and cardiothoracic surgeons were jointly responsible for TAVR referrals (83.7%; 339 of 405), and TAVR programs were administered either jointly by the cardiology and cardiac surgery departments or exclusively by the cardiac surgery department (73.3%; 297 of 405). A majority were involved in the pre-, intra-, and postoperative care of patients undergoing TAVR, with 91.4% (370 of 405) reporting participation in multidisciplinary meetings, at least 50% regularly performing technical aspects in 10 of 11 conduct of operation categories, and 86.6% (266 of 307) caring for patients undergoing TAVR after the procedure., Conclusions: Cardiac surgeons in the United States are active participants in the management of patients with aortic stenosis as part of the heart team. The STS survey found that not only were they actively involved in the treatment decision-making process but they also played a significant role in the valve procedure, including deployment and postprocedural care. The heart team model continues to evolve and should be expanded into other areas of structural heart disease., (Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Nearly 50% of patients undergoing coronary artery bypass grafting have diabetes. However, little is known about the influence of diabetes on long-term patency of bypass grafts. Because patients with diabetes have more severe coronary artery stenosis, we hypothesized that graft patency is worse in patients with than without diabetes., Objectives: This study sought to examine the influence of diabetes on long-term patency of bypass grafts., Methods: From 1972 to 2011, 57,961 patients underwent primary isolated coronary artery bypass grafting. Of these, 1,372 pharmacologically treated patients with diabetes and 10,147 patients without diabetes had 15,887 postoperative angiograms; stenosis was quantified for 7,903 internal thoracic artery (ITA) grafts and 20,066 saphenous vein grafts. Status of graft patency across time was analyzed by longitudinal nonlinear mixed-effects modeling., Results: ITA graft patency was stable over time and similar in patients with and without diabetes: at 1, 5, 10, and 20 years, 97%, 97%, 96%, and 96% in patients with diabetes, and 96%, 96%, 95%, and 93% in patients without diabetes, respectively (early p = 0.20; late p = 0.30). In contrast, saphenous vein graft patency declined over time and similarly in patients with and without diabetes: at 1, 5, 10, and 20 years, 78%, 70%, 57%, and 42% in patients with diabetes, and 82%, 72%, 58%, and 41% in patients without diabetes, respectively (early p < 0.002; late p = 0.60). After adjusting for patient characteristics, diabetes was associated with higher early patency of ITA grafts (odds ratio: 0.63; 95% confidence limits: 0.43 to 0.91; p = 0.013), but late patency of ITA grafts was similar in patients with and without diabetes (p = 0.80). Early and late patency of saphenous vein grafts were similar in patients with and without diabetes (early p = 0.90; late p = 0.80)., Conclusions: Contrary to our hypothesis, diabetes did not influence long-term patency of bypass grafts. Use of ITA grafts should be maximized in patients undergoing coronary artery bypass grafting because they have excellent patency in patients with and without diabetes even after 20 years., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: For mitral regurgitation (MR) from degenerative mitral disease in patients with coexisting coronary artery disease, the appropriate surgical strategy remains controversial., Methods: From 1985 to 2011, 1,071 adults (age 70 ± 9.3 years, 77% men) underwent combined coronary artery bypass grafting and either mitral valve repair (n = 872, 81%) or replacement (n=199, 19%) for degenerative MR. Propensity matching (177 patient pairs, 89% of possible matches) was used to compare early outcomes and time-related recurrence of MR after mitral valve repair, mitral valve reoperation, and mortality. Risk factors for death were identified with multivariable, multiphase hazard-function analysis., Results: Patients undergoing valve replacement were older, with more valve calcification and a higher prevalence of preoperative atrial fibrillation and heart failure (all p < .0001). Among matched pairs, mitral replacement versus repair was associated with higher hospital mortality (5.0% vs 1.0%, p = .0001) and more postoperative renal failure (7.0% vs 3.2%, p = .01), reexplorations for bleeding (6.0% vs 3.1%, p = .05), and respiratory failure (14% vs 4.7%, p < .0001). Of matched patients undergoing repair, 18% had MR above 3+ by 5 years. Mitral valve durability was similar between matched groups, but survival at 15 years was 18% after replacement versus 52% after repair. Nomograms from the multivariable equation revealed that in 94% of cases, 10-year survival was calculated to be higher after repair than after replacement., Conclusions: In patients with coexisting degenerative mitral valve and coronary artery diseases, mitral valve repair is expected to confer a long-term survival advantage over replacement despite some recurrence of MR. When feasible, it is the procedure of choice for these patients., (Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Objectives: To (1) identify sex-related differences in risk factors and revascularization strategies for patients undergoing coronary artery bypass grafting (CABG), (2) assess whether these differences influenced early and late survival, and (3) determine whether clinical effectiveness of the same revascularization strategy was influenced by sex., Methods: From January 1972 to January 2011, 57,943 adults-11,009 (19%) women-underwent primary isolated CABG. Separate models for long-term mortality were developed for men and women, followed by assessing sex-related differences in strength of risk factors (interaction terms)., Results: Incomplete revascularization was more common in men than women (26% vs 22%, P < .0001), but women received fewer bilateral internal thoracic artery (ITA) grafts (4.8% vs 12%; P < .0001) and fewer arterial grafts (68% vs 70%; P < .0001). Overall, women had lower survival than men after CABG (65% and 31% at 10 and 20 years, respectively, vs 74% and 41%; P ≤ .0001), even after risk adjustment. Incomplete revascularization was associated equally (P > .9) with lower survival in both sexes. Single ITA grafting was associated with equally (P = .3) better survival in women and men. Although bilateral ITA grafting was associated with better survival than single ITA grafting, it was less effective in women-11% lower late mortality (hazard ratio, 0.89 [0.77-1.022]) versus 27% lower in men (hazard ratio, 0.73 [0.69-0.77]; P = .01)., Conclusions: Women on average have longer life expectancies than men but not after CABG. Every attempt should be made to use arterial grafting and complete revascularization, but for unexplained reasons, sex-related differences in effectiveness of bilateral arterial grafting were identified., (Copyright © 2016. Published by Elsevier Inc.)

Background: Less-invasive techniques have previously been described for mitral and aortic valve operations; however, few studies have examined their benefit for aortic root and ascending aorta reconstruction. Using propensity matching, we compared outcomes of patients undergoing proximal aortic operations through a J incision compared with full sternotomy., Methods: From January 1995 to January 2014, 8,533 patients underwent proximal aortic operations at Cleveland Clinic. The study population comprised 1,827 patients after those with prior cardiac operations, emergency procedures, endocarditis, or circulatory arrest were excluded; 568 (31%) underwent a J incision. A propensity score based on 57 variables was generated to account for differences in characteristics of full-sternotomy and J-incision patients, producing 483 matched patient pairs (85% of possible) for comparison of outcomes., Results: Among propensity-matched patients, in-hospital mortality (0 [0%] J incision vs 2 [0.41%] full sternotomy; p = 0.2), renal failure (3 [0.62%] vs 6 [1.2%]; p = 0.3), stroke (3 [0.62%] vs 3 [0.62%; p > 0.9), reoperation for bleeding (17 [3.5%] vs 15 [3.1%]; p = 0.7), intraoperative blood products (60 [15%] vs 78 [19%]; p = 0.08), and postoperative transfusions (97 [20%] vs 103 [22%]; p = 0.6) were similar. Intensive care unit (median 24 vs 26 hours) and postoperative hospital stays (median 5.2 vs 6.0 days) were shorter (p < 0.0001) for the J incision, and operative and postoperative direct technical costs were 6% less., Conclusions: A J incision is a feasible technique for primary isolated elective proximal aortic operations, with a low risk of complications similar to those of full sternotomy, but with the advantages of shorter intensive care unit and hospital stays, lower costs, and better cosmesis., (Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Data regarding long-term outcomes in cardiovascular pseudoaneurysms are sparse. In patients with prior cardiovascular surgery, we sought to assess characteristics and outcomes in patients with cardiovascular pseudoaneurysms (excluding ischemic left ventricular pseudoaneurysms)., Methods: We included 114 patients (mean age, 57 ± 16 years; 70% were men) with prior cardiovascular surgery who presented with paravalvular (n = 71, 59 aortic and 12 mitral valve) and ascending aortic (n = 43) pseudoaneurysms (27% with systemic infection). Baseline, surgical, and follow-up data were recorded. A composite end point of stroke or death during follow-up was recorded., Results: Additive European System for Cardiac Operative Risk Evaluation was high (10%), and 81% of patients underwent another redo cardiovascular surgery. Over a mean follow-up period of 5.2 ± 4 years, there were 37 (32%) composite events (32 deaths and 5 strokes). Within the surgical subgroup, there were 10 (11%) composite events during the in-hospital stay. The 1-, 2-, 5-, and 10-year freedom from composite events were 86%, 82%, 74%, and 55%, respectively. Additive European System for Cardiac Operative Risk Evaluation (hazard ratio, 1.14) and presence of a documented systemic infection (hazard ratio, 3.90) were associated with a higher rate of composite events, whereas subsequent cardiovascular surgery as a time-dependent covariate hazard ratio (hazard ratio, 0.30) was associated with improved freedom from composite events (all P < .05)., Conclusions: Patients with a history of cardiovascular surgery in whom cardiovascular pseudoaneurysms subsequently develop have a high rate of short- and long-term adverse events. A higher additive European System for Cardiac Operative Risk Evaluation and documented systemic infection were associated with a higher rate of composite events, whereas cardiovascular surgery (to correct cardiovascular pseudoaneurysms) during follow-up was associated with improved freedom from adverse events., (Copyright © 2016 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Background: We hypothesized that factors associated with an institution's residual risk unaccounted for by population-based models may be identifiable and used to enhance the value of population-based risk scores for quality improvement., Methods: From January 2000 to January 2010, 4,971 patients underwent aortic valve replacement (AVR), either isolated (n = 2,660) or with concomitant coronary artery bypass grafting (AVR+CABG; n = 2,311). Operative mortality and major morbidity and mortality predicted by The Society of Thoracic Surgeons (STS) risk models were compared with observed values. After adjusting for patients' STS score, additional and refined risk factors were sought to explain residual risk. Differences between STS model coefficients (risk-factor strength) and those specific to our institution were calculated., Results: Observed operative mortality was less than predicted for AVR (1.6% [42 of 2,660] vs 2.8%, p < 0.0001) and AVR+CABG (2.6% [59 of 2,311] vs 4.9%, p < 0.0001). Observed major morbidity and mortality was also lower than predicted for isolated AVR (14.6% [389 of 2,660] vs 17.5%, p < 0.0001) and AVR+CABG (20.0% [462 of 2,311] vs 25.8%, p < 0.0001). Shorter height, higher bilirubin, and lower albumin were identified as additional institution-specific risk factors, and body surface area, creatinine, glomerular filtration rate, blood urea nitrogen, and heart failure across all levels of functional class were identified as refined risk-factor variables associated with residual risk. In many instances, risk-factor strength differed substantially from that of STS models., Conclusions: Scores derived from population-based models can be enhanced for institutional level use by adjusting for institution-specific additional and refined risk factors. Identifying these and measuring differences in institution-specific versus population-based risk-factor strength can identify areas to target for quality improvement initiatives., (Copyright © 2016 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Guidelines supporting the decision to replace the aorta in patients with chronic asymptomatic proximal aortic disease are limited by lack of data on operative risks and long-term effectiveness in relation to aortic size. Therefore, we assessed and compared outcomes of patients undergoing elective isolated proximal aortic replacement for this disease vs replacement during multicomponent operations., Methods: From January 2006 to January 2011, 1,889 patients underwent proximal aortic replacement (isolated, 212; multicomponent, 1,677) for chronic asymptomatic ascending and arch pathology. Mean age was 60 ± 14 years, and maximum proximal aortic diameter was 52 ± 10 mm (isolated) and 49 ± 10 mm (multicomponent; p = 0.0004). Propensity matching using 64 preoperative variables yielded 197 well-matched patient pairs., Results: Patients were more likely to undergo isolated replacement if they had prior cardiac operations and a larger middescending aortic diameter (p < 0.0001). Multicomponent operations were more common among those with connective tissue disorder or porcelain aorta. Among propensity-matched patients, in-hospital mortality was 1 of 197 (0.5%) in the isolated group vs 8 of 197 (4.1%) in the multicomponent group. Occurrence of stroke, renal failure, and prolonged ventilation were similar. Median postoperative stay was 7.9 vs 8.1 days (p = 0.07). At 30 days, 1 year, and 4 years, survival was 97%, 93%, and 87%, and freedom from reintervention was 98%, 90%, and 89%, respectively, similar between groups., Conclusions: Elective ascending aortic replacement is safe and effective. Ascending aneurysms should be treated aggressively even when encountered in patients undergoing a multicomponent operation. An aggressive approach to replacement of the ascending aorta may be warranted given the increased risk of stroke during a subsequent reoperation., (Copyright © 2016 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Postoperative stroke is a devastating complication after aortic valve replacement (AVR). Our objective was to use a large national database to identify the incidence of and risk factors for stroke after AVR, as well as to determine incremental mortality, resource use, and cost of stroke., Methods: We identified 360,437 patients who underwent isolated surgical AVR between 1998 and 2011 from the National Inpatient Sample (NIH) database. Mean age was 66 ± 32 years. Multivariable regression and propensity matching were used to identify risk factors and the effect of stroke on outcomes. Patients were stratified according to the Elixhauser comorbidity score (ECS) into low- (0-5), medium- (6-15), and high-risk (16+) categories., Results: Stroke after AVR occurred in 5,092 (1.45%) patients. The incidence of stroke declined from 1.69% in 1999 to 0.94% in 2011 (p < 0.001). Increasing age and higher comorbidities were the main predictors of stroke (each p < 0.001). The highest-volume centers (>200 AVRs/y) had the lowest rate of stroke (1.2%). After multivariable adjustment, high-volume centers had lower odds of stroke in medium-risk (odds ratio [OR], 0.59; 95% confidence interval [CI], 0.37-0.94) and high-risk patients (OR, 0.39; 95% CI, 0.22-0.68) compared with the lowest-volume centers. For low-risk patients, volume was not associated with stroke. Patients who experienced stroke were hospitalized for 4 days longer, had an average of $10,496 higher costs, and had 2.74 (95% CI, 1.97-3.80) times higher odds of in-hospital mortality compared with those who did not experience stroke (all p < 0.001)., Conclusions: The incidence of stroke after AVR has decreased but remains a significant cause of morbidity in medium- and high-risk patients. Superior outcomes can be achieved in medium- to high-risk patients at high-volume centers., (Copyright © 2016 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Objective: Stenting coronary arteries with non-ischemia-producing moderate stenosis leads to worse outcomes than leaving them unstented. We sought to determine whether grafting coronary arteries with angiographically moderate stenosis is associated with worse long-term survival than leaving them ungrafted., Methods: From 1972 to 2011, 55,567 patients underwent primary isolated coronary artery bypass grafting (CABG); 8531 had a single coronary artery with moderate (50%-69%) stenosis, bypassed in 6598 (77%) and not bypassed in 1933 (23%). These arteries were grafted with internal thoracic arteries (ITAs) in 1806 patients (27%) and with saphenous veins (SVs) in 4625 (70%). Mean follow-up for all-cause mortality was 13.0 ± 9.7 years., Results: Survival was similar for patients with and without a graft to the moderately stenosed coronary artery (P = .3): 97%, 76%, 43%, and 18% at 1, 10, 20, and 30 years among patients receiving no graft; 97%, 74%, 41%, and 18% among those receiving an SV graft; and 98%, 82%, 51%, and 23% among those receiving an ITA graft. After adjusting for patient characteristics, SV grafting versus nongrafting of moderately stenosed coronary arteries was associated with similar long-term mortality (P = .2), whereas ITA grafting was associated with 22% lower long-term mortality (hazard ratio 0.78; 68% confidence interval 0.75-0.82; P < .0001)., Conclusions: Grafting coronary arteries with angiographically moderate stenosis is not harmful. Instead, ITA grafting of such coronary arteries is associated with lower long-term mortality. Thus, after placing the first ITA to the left anterior descending, the second ITA should be placed to the second most important coronary artery, even if it is moderately stenosed., (Copyright © 2016. Published by Elsevier Inc.)

Background: Improvements in care have prolonged survival of patients with connective tissue disorders (CTDs), but their entire native aorta remains at risk. Little data are available to guide treatment. Objectives were to characterize patients, describe repair methods, and assess outcomes., Methods: From 1996 to 2012, 527 patients with CTDs underwent cardiovascular operations. Beyond the root, arch and descending repair was performed in 121 patients (23%) for aneurysm (n = 17), acute complicated dissection (n= 5), or chronic dissection with aneurysmal degeneration (n = 99). CTD diagnoses included Marfan (n = 107), marfanoid (n = 7), Ehlers-Danlos (n = 4), and Loeys-Dietz (n = 3) syndromes. Eighty-seven (72%) had a previous ascending aorta repair, including 51 (57%) for type A dissection. Median interval to distal operation was 8.4 years. Index procedures for repair beyond the root were elephant trunk (ET) stage I (n = 63), open descending repair (n = 26), thoracoabdominal repair (n = 13), total arch replacement (n = 13), and stent-grafting (n = 6: frozen ET 3, thoracic endovascular aortic repair [TEVAR] 3). Median follow-up was 4.4 years., Results: Operative mortality was 2.5% (3 of 121). No paralysis occurred, but 3 patients (2.5%) had nonpermanent stroke, 4 (3.3%) required dialysis, 12 (10%) required tracheostomy, and 13 (11%) underwent reoperation for bleeding. During follow-up, 67 patients underwent 85 additional distal aortic procedures (58 open, 27 endovascular, 49 of which were stage II ET). By 10 years, probability of at least 1 reintervention was 61%. At 1, 5, and 10 years, estimated survival was 91%, 79%, and 62%, and event-free survival was 52%, 35%, and 24%, respectively., Conclusions: Most patients with CTDs who require operations beyond the aortic root have aortic dissection and require multiple reinterventions. Staged repair strategies, including open repair in combination with TEVAR, are feasible, and benefits outweigh risks. These patients require lifelong imaging surveillance., (Copyright © 2016 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Objectives: To determine whether nonselective preoperative carotid artery ultrasound screening alters management of patients scheduled for coronary artery bypass grafting (CABG), and whether such screening affects neurologic outcomes., Methods: From March 2011 to September 2013, preoperative carotid artery ultrasound screening was performed on 1236 of 1382 patients (89%) scheduled to undergo CABG. Carotid artery stenosis (CAS) was classified as none or mild (any type 0%-59% stenosis), moderate (unilateral 60%-79% stenosis), or severe (bilateral 60%-79% stenosis or unilateral 80%-100% stenosis)., Results: A total of 1069 (86%) had