Cost-Effectiveness of Percutaneous Coronary Intervention Versus Bypass Surgery for Patients With Left Main Disease: Results From the EXCEL Trial.

BACKGROUND: The EXCEL trial (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) demonstrated in patients with left main coronary artery disease, no significant difference between coronary artery bypass graft surgery (CABG) and percutaneous coronary intervention (PCI) with everolimus-eluting stents for the composite end point of death, stroke, or myocardial infarction at 5 years. However, all-cause mortality at 5 years was higher with PCI. Long-term cost-effectiveness of these 2 strategies has heretofore not been evaluated. METHODS: From 2010 to 2014, 1905 patients with left main coronary artery disease were randomized to CABG (n=957) or PCI (n=948). Costs ($2019) were assessed over 5 years using resource-based costing and Medicare reimbursement rates. Health utilities were assessed using the EuroQOL 5-dimension questionnaire. Five-year EXCEL data in combination with US lifetables were used to develop a Markov model to evaluate lifetime cost-effectiveness. An incremental cost-effectiveness ratio <$50 000 per quality-adjusted life year (QALY) gained was considered highly cost-effective. RESULTS: Index revascularization procedure costs were $4,850/patient higher with CABG, and total costs for the index hospitalization were $17 610/patient higher with CABG ($32 297 versus $19 687, P<0.001). Cumulative 5-year costs were $20 449/patient higher with CABG. CABG was projected to increase lifetime costs by $21 551 while increasing quality-adjusted life expectancy by 0.49 QALYs, yielding an incremental cost-effectiveness ratio of $44 235/QALY. In a post hoc sensitivity analysis using mortality hazard ratios from a meta-analysis of all randomized CABG versus PCI in left main disease trials, the gain associated with CABG was 0.08 to 0.14 QALYs, resulting in an incremental cost-effectiveness ratio of $139 775 to $232 710/QALY gained. CONCLUSIONS: Based on data from the EXCEL trial, CABG is an economically attractive revascularization strategy compared with PCI over a lifetime horizon for patients with significant left main coronary artery disease. However, this conclusion is sensitive to the long-term mortality rates with the 2 strategies, and CABG is no longer highly cost-effective when substituting the pooled treatment effect from the 4 major PCI versus CABG trials for left main disease. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT01205776.

Coronary Artery Bypass Grafting in Cancer Patients: Prevalence and Outcomes in the United States.

OBJECTIVE: To characterize the contemporary efficacy and utilization patterns of coronary artery bypass grafting (CABG) in specific cancer types. METHODS: We leveraged the data from the National Inpatient Sample and plotted trends of utilization and outcomes of isolated CABG (with no other additional surgeries during the same hospitalization) procedures from January 1, 2003, through September 1, 2015. Propensity score matching was used to assess for potential differences in outcomes by type of cancer status among contemporary (2012-2015) patients. RESULTS: Overall, the utilization of CABG decreased over time (250,677 in 2003 vs 134,534 in 2015, P<.001). However, the proportion of those with comorbid cancer increased (7.0% vs 12.6%, P<.001). Over time, in-hospital mortality associated with CABG use in cancer remained unchanged (.9% vs 1.0%, P=.72); yet, cancer patients saw an increase in associated major bleeding (4.5% vs 15.3%, P<.001) and rate of stroke (.9% vs 1.5%, P<.001) over time. In-hospital cost-of-care associated with CABG-use in cancer also increased over time ($29,963 vs $33,636, P<.001). When stratified by cancer types, in-hospital mortality was not higher in breast, lung, prostate, colon cancer, or lymphoma versus non-cancer CABG patients (all P>.05). However, there was a significantly higher prevalence of major bleeding but not stroke in patients with breast and prostate cancer only compared with non-cancer CABG patients (P<.01). Discharge dispositions were not found to be different between cancer sub-groups and non-cancer patients (P>.05), except for breast cancer patients who had lower home care, but higher skilled care disposition (P<.001). CONCLUSION: Among those undergoing CABG, the prevalence of comorbid cancer has steadily increased. Outside of major bleeding, these patients appear to share similar outcomes to those without cancer indicating that CABG utilization should be not be declined in cancer patients when otherwise indicated. Further research into the factors underlying the decision to pursue CABG in specific cancer sub-groups is needed.

Association of Acute Venous Thromboembolism With In-Hospital Outcomes of Coronary Artery Bypass Graft Surgery.

Background While venous thromboembolism (VTE) prophylaxis is a strong recommendation after most surgeries, it is controversial in cardiac surgeries such as coronary artery bypass grafting (CABG), because of perceived low VTE incidence and increased bleeding risk. Prior studies may not have been adequately powered to study outcomes of VTE in this population. We sought to investigate the postoperative incidence and outcomes of CABG patients using a large national inpatient database. Methods and Results We utilized the 2013 to 2014 National Inpatient Sample to identify all patients >18 years of age who underwent CABG (without concomitant valvular procedures), and had VTE during the hospital stay. We then compared clinically relevant outcomes in patients with and without VTE. We identified 331 950 CABG procedures. Of these, 1.3% (n=4205) had VTE. Patients with VTE were more likely to be older (mean 67.2±10.4 years versus 65.2±10.4 years, P<0.001). VTE was associated with higher incidence of inpatient mortality (6.8% versus 1.7%; adjusted odds ratio 1.92 [95% CI 1.40-2.65]; P<0.001) and complications. VTE was also associated with higher cost (mean±SE $81 995±$923 versus $48 909±$55) and longer length of stay (mean±SE 17.06±0.16 days versus 8.52±0.01 days). Conclusions Our analysis of >330 000 CABG procedures suggests that while postoperative VTE after CABG is rare, it is associated with increased morbidity and mortality. Randomized controlled trials are needed to identify optimal strategies for VTE prophylaxis in these patients.

Association of Coronary Anatomical Complexity With Clinical Outcomes After Percutaneous or Surgical Revascularization in the Veterans Affairs Clinical Assessment Reporting and Tracking Program.

Importance: Anatomical scoring systems for coronary artery disease, such as the SYNTAX (Synergy Between Percutaneous Coronary Intervention [PCI] With Taxus and Cardiac Surgery) score, are well established tools for understanding patient risk. However, they are cumbersome to compute manually for large data sets, limiting their use across broad and varied cohorts. Objective: To adapt an anatomical scoring system for use with registry data, allowing facile and automatic calculation of scores and association with clinical outcomes among patients undergoing percutaneous or surgical revascularization. Design, Setting, and Participants: This cross-sectional observational cohort study involved procedures performed in all cardiac catheterization laboratories in the largest integrated health care system in the United States, the Veterans Affairs (VA) Healthcare System. Patients undergoing coronary angiography in the VA Healthcare System followed by percutaneous or surgical revascularization within 90 days were observed and data were analyzed from January 1, 2010, through September 30, 2017. Main Outcomes and Measures: An anatomical scoring system for coronary artery disease complexity before revascularization was simplified and adapted to data from the VA Clinical Assessment, Reporting, and Tracking Program. The adjusted association between quantified anatomical complexity and major adverse cardiovascular and cerebrovascular events (MACCEs), including death, myocardial infarction, stroke, and repeat revascularization, was assessed for patients undergoing percutaneous or surgical revascularization. Results: A total of 50 226 patients (49 359 men [98.3%]; mean [SD] age, 66 [9] years) underwent revascularization during the study period, with 34 322 undergoing PCI and 15 904 undergoing coronary artery bypass grafting (CABG). After adjustment, the highest tertile of anatomical complexity was associated with increased hazard of MACCEs (adjusted hazard ratio [HR], 2.12; 95% CI, 2.01-2.23). In contrast, the highest tertile of anatomical complexity among patients undergoing CABG was not independently associated with overall MACCEs (adjusted HR, 1.04; 95% CI, 0.92-1.17), and only repeat revascularization was associated with increasing complexity (adjusted HR, 1.34; 95% CI, 1.06-1.70) in this subgroup. Conclusions and Relevance: These findings suggest that an automatically computed score assessing anatomical complexity can be used to assess longitudinal risk for patients undergoing revascularization. This simplified scoring system appears to be an alternative tool for understanding longitudinal risk across large data sets.

Risk Calculator to Predict 30-Day Readmission After Coronary Artery Bypass: A Strategic Decision Support Tool.

BACKGROUND: Re-admission is an important source of patient dissatisfaction and increased hospital costs. A simple calculator to determine the probability of re-admission may help guide patient dismissal planning. METHODS: Using the national readmissions database (NRD), we identified admissions for isolated primary coronary artery bypass (CABG) and stratified them according to 30-day readmission. Including pre, intra and postoperative variables, we prepared a logistic regression model to determine the probability for re-admission. The model was tested for reliability with boot-strapping and 10-fold cross-validation. RESULTS: From 135,699 procedures, 19,355 were readmitted at least once within 30days of dismissal. Patients who were readmitted were older (67±10 vs 65 ± 10 years, p<0.01), females (32% vs 24%; p<0.01) and had a higher Elixhauser comorbidity score (1.5±1.4 vs 1.1±1.2; p<0.01). Our final model (c- statistic=0.65) consisted of 16 pre and three postoperative factors. End-stage renal disease (OR 1.79 [1.57-2.04]) and length of stay>9days (OR 1.60 [1.52-1.68]) were most prominent indicators for readmission. Compared to Medicaid beneficiaries, those with private insurance (OR 0.62 [0.57-0.68]) and Medicare (OR 0.85 [0.79-0.92]) coverage were less likely to be readmitted. CONCLUSIONS: Our simple 30-days CABG readmission calculator can be used as a strategic tool to help reduce readmissions after coronary artery bypass surgery.

Outcomes After Coronary Stenting or Bypass Surgery for Men and Women With Unprotected Left Main Disease: The EXCEL Trial.

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.

B-Type Natriuretic Peptide Assessment in Patients Undergoing Revascularization for Left Main Coronary Artery Disease: Analysis From the EXCEL Trial.

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 ( Pinteraction=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 ( Pinteraction=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.

Implications from neurologic assessment of brain protection for total arch replacement from a randomized trial.

OBJECTIVE: The study objective was to perform a randomized trial of brain protection during total aortic arch replacement and identify the best way to assess brain injury. METHODS: From June 2003 to January 2010, 121 evaluable patients were randomized to retrograde (n = 60) or antegrade (n = 61) brain perfusion during hypothermic circulatory arrest. We assessed the sensitivity of clinical neurologic evaluation, brain imaging, and neurocognitive testing performed preoperatively and 4 to 6 months postoperatively to detect brain injury. RESULTS: A total of 29 patients (24%) experienced neurologic events. Clinical stroke was evident in 1 patient (0.8%), and visual changes were evident in 2 patients; all had brain imaging changes. A total of 14 of 95 patients (15%) undergoing both preoperative and postoperative brain imaging had evidence of new white or gray matter changes; 10 of the 14 patients had neurocognitive testing, but only 2 patients experienced decline. A total of 17 of 96 patients (18%) undergoing both preoperative and postoperative neurocognitive testing manifested declines of 2 or more reliable change indexes; of these 17, 11 had neither imaging changes nor clinical events. Thirty-day mortality was 0.8% (1/121), with no neurologic deaths and a similar prevalence of neurologic events after retrograde and antegrade brain perfusion (22/60, 37% and 15/61, 25%, respectively; P = .2). CONCLUSIONS: Although this randomized clinical trial revealed similar neurologic outcomes after retrograde or antegrade brain perfusion for total aortic arch replacement, clinical examination for postprocedural neurologic events is insensitive, brain imaging detects more events, and neurocognitive testing detects even more. Future neurologic assessments for cardiovascular procedures should include not only clinical examination but also brain imaging studies, neurocognitive testing, and long-term assessment.

Coronary artery bypass grafting in diabetics: A growing health care cost crisis.

OBJECTIVES: To determine 4-decade temporal trends in the prevalence of diabetes and cardiovascular risk factors among patients undergoing coronary artery bypass grafting (CABG) and to compare in-hospital outcomes, resource utilization, and long-term survival after CABG in diabetics versus nondiabetics. METHODS: From January 1972 to January 2011, 10,362 pharmacologically treated diabetics and 45,139 nondiabetics underwent first-time CABG. Median follow-up was 12 years. Direct technical cost data were available from 2003 onward (n = 4679). Propensity matching by diabetes status was used for outcome comparisons. Endpoints were in-hospital adverse events, resource utilization, and long-term survival. RESULTS: Diabetics undergoing CABG increased from 7% in the 1970s to 37% in the 2000s. Their outcomes were worse, with more (P < .05) in-hospital deaths (2.0% vs 1.3%), deep sternal wound infections (2.3% vs 1.2%), strokes (2.2% vs 1.4%), renal failure (4.0% vs 1.3%), and prolonged postoperative hospital stay (9.6% vs 6.0%); and their hospital costs were 9% greater (95% confidence interval 7%-11%). Survival after CABG among diabetics versus nondiabetics at 1, 5, 10, and 20 years was also worse: 94% versus 94%, 80% versus 84%, 56% versus 66%, and 20% versus 32%, respectively. Propensity-matched patients incurred similar costs, but the prevalence of postoperative deep sternal wound infections and stroke, as well as long-term survival, remained worse in diabetics. CONCLUSIONS: Diabetes is both a marker for high-risk, resource-intensive, and expensive care after CABG and an independent risk factor for reduced long-term survival. These issues, coupled with the increasing proportion of patients needing CABG who have diabetes, are a growing challenge in reining in health care costs.

Open aortic repair after prior thoracic endovascular aortic repair.

BACKGROUND: Thoracic endovascular aortic repair (TEVAR) has been applied to increasingly complex aortic pathology, resulting in an increase in late complications. We characterized patients undergoing open repair after prior TEVAR including indications, operative techniques, and outcomes. METHODS: Chart review and query of a prospectively collected database identified 50 patients who underwent thoracic aortic operation after prior TEVAR. Active follow-up was supplemented by Social Security information for vital status. RESULTS: From July 2001 to January 2012 open arch (n = 25), descending (n = 6), thoracoabdominal (n = 17), or extra-anatomic bypass (n = 2) operations were performed after previous TEVAR (median interval from TEVAR to open surgical procedure: 13.9 months; interquartile range, 0.5 to 24 months). Indications for open operation included type 1 endoleaks (n = 19), retrograde aortic dissection (n = 9), chronic aortic dissection with persistent growth of the false lumen (n = 16), and graft infection (n = 6). Sixty percent had prior cardiovascular surgical procedures and 18% were done as emergencies. Circulatory support was required in 78% and hypothermic arrest in 48%. Hospital mortality occurred in 3 (6%) patients with no strokes and 1 patient with myocardial infarction; 5 (10%) patients required tracheostomy and 1 required dialysis. Survival was 67% at a median follow-up of 2.9 years. CONCLUSIONS: Conversion to open repair after thoracic stent-grafting may be indicated for type 1 endoleak, retrograde dissection, chronic aortic dissection with persistent false lumen growth, or graft infection. These salvage operations are complex but can be completed safely with good early outcomes and preservation of the stent-graft in most cases. Late outcomes are consistent with the chronic disease state of these patients.

The least of 3 evils: exposure to red blood cell transfusion, anemia, or both?

BACKGROUND: Anemia and red blood cell (RBC) transfusions are both associated with morbidity and mortality after cardiac surgery. Patients with the lowest hematocrit (HCT) values during cardiopulmonary bypass (CPB) are the most likely to receive a transfusion, which results in a double-negative exposure. We aimed to clarify the effects of anemia, transfusion, and their combination to identify which imposes the greatest risk of end-organ dysfunction and mortality. METHODS: From November 1, 2004, to November 1, 2009, 7942 patients underwent procedures requiring CPB and did not receive intraoperative or postoperative RBC transfusion, and 1202 received intraoperative RBC transfusion alone. They were divided into 4 groups: intraoperative nadir HCT ≥25% without RBC transfusion, ≥25% with RBC transfusion, <25% without RBC transfusion, and <25% with RBC transfusion. The relationship among HCT, RBC, and outcomes was studied using generalized propensity-score analysis. Outcomes included estimated glomerular filtration rate (eGFR), troponin, ventilatory support time, length of stay, and mortality. RESULTS: After risk adjustment, comparison of all 4 groups showed that double exposure to anemia (HCT <25%) and RBC transfusion was associated with the highest risk: lowest eGFR (P = .008), highest troponin values (P = .01), longest ventilator requirement (P < .001), longest length of stay (P < .001), and highest mortality (P = .007). Single exposure to either HCT <25% or RBC transfusion alone was associated with the next risk category, and the lowest morbidity risk was associated with neither exposure. CONCLUSIONS: Although single exposure to anemia or RBC transfusion alone was associated with risk, it was generally lower than that of anemia and RBC exposure in combination.

A direct comparison of early and late outcomes with three approaches to carotid revascularization and open heart surgery.

OBJECTIVES: The aim of this study was a comparison of risk-adjusted outcomes of 3 approaches to carotid revascularization in the open heart surgery (OHS) population. BACKGROUND: Without randomized clinical trials, the best approach to managing coexisting severe carotid and coronary disease remains uncertain. Staged carotid endarterectomy (CEA) followed by OHS or combined CEA and OHS are commonly used. A recent alternative is carotid artery stenting (CAS). METHODS: From 1997 to 2009, 350 patients underwent carotid revascularization within 90 days before OHS at a tertiary center: 45 staged CEA-OHS, 195 combined CEA-OHS, and 110 staged CAS-OHS. The primary composite endpoint was all-cause death, stroke, and myocardial infarction (MI). Staged CAS-OHS patients had higher prevalence of previous stroke (p = 0.03) and underwent more complex OHS. Therefore, the propensity score adjusted multiphase hazard function models with modulated renewal to account for staging, and competing risks were used. RESULTS: Using propensity analysis, staged CAS-OHS and combined CEA-OHS had similar early hazard phase composite outcomes, whereas staged CEA-OHS incurred the highest risk driven by interstage MI. Subsequently, staged CAS-OHS patients experienced significantly fewer late hazard phase events compared with both staged CEA-OHS (adjusted hazard ratio: 0.33; 95% confidence interval: 0.15 to 0.77; p = 0.01) and combined CEA-OHS (adjusted hazard ratio: 0.35; 95% confidence interval: 0.18 to 0.70; p = 0.003). CONCLUSIONS: Staged CAS-OHS and combined CEA-OHS are associated with a similar risk of death, stroke, or MI in the short term, with both being better than staged CEA-OHS. However, the outcomes significantly favor staged CAS-OHS after the first year.

A comprehensive review of the PARTNER trial.

OBJECTIVE: Percutaneous transcatheter aortic valve replacement was introduced in 2002, but its effectiveness remained to be assessed. METHODS: A prospective, randomized trial (the Placement of Aortic Transcatheter Valves, or PARTNER) was designed with 2 arms: PARTNER A (n = 699) for high-risk surgical patients (Society of Thoracic Surgeons score >10%, surgeon assessed risk of mortality >15%) and PARTNER B (n = 358, patients inoperable by assessment of 2 surgeons). PARTNER A patients were divided into femoral artery access transcatheter aortic valve replacement or none (n = 207), and then randomized to open aortic valve replacement (n = 351) or device (n = 348). Inclusion criteria included valve area <0.8 cm(2), gradient >40 mm Hg or peak >64 mm Hg, and survival >1 year. The end point of the study was 1-year mortality. RESULTS: Thirty-day mortality for PARTNER A was 3.4% for transcatheter aortic valve replacement and 6.5% for aortic valve replacement; 1-year mortality was 24.2% and 26.8%, respectively (P = .001 for noninferiority). The respective prevalence of stroke was 3.8% and 2.1% (P = .2), although for all neurologic events, the difference between transcatheter aortic valve replacement and aortic valve replacement was significant (P = .04), including 4.6% for femoral artery access transcatheter aortic valve replacement versus 1.4% for open aortic valve replacement (P = .05). For PARTNER B--transcatheter aortic valve replacement versus medical treatment-30-day mortality was 5.0% versus 2.8% (P = .41), and at 1 year, mortality was 30.7% versus 50.7% (P < .001), respectively. Hospitalization cost of transcatheter aortic valve replacement for PARTNER B was $78,542, or $50,200 per year of life gained. Analysis of PARTNER A strokes showed that hazard with transcatheter aortic valve replacement peaked early, but thereafter remained constant in relation to aortic valve replacement. Two-year PARTNER A data showed paravalvular regurgitation was associated with increased mortality, even when mild (P < .001). Continued access to transapical transcatheter aortic valve replacement (n = 853) showed a mortality of 8.2% and decline in strokes to 2.0%. Of the 1801 Cleveland Clinic patients reviewed to December 2010, 214 (12%) underwent transcatheter aortic valve replacement with a mortality of 1%; in 2011, 105 underwent transcatheter aortic valve replacement: 34 transapical aortic valve replacement, with no deaths, and 71 femoral artery access aortic valve replacement with 1 death. CONCLUSIONS: The PARTNER A and B trials showed that survival has been remarkably good, but stroke and perivalvular leakage require further device development.

Clinical and angiographic risk assessment in patients with left main stem lesions.

Percutaneous coronary intervention of unprotected left main stem lesions has been shown to be a suitable alternative to cardiac surgery in selected patients, emphasizing the need for appropriate risk stratification prior to selection of revascularization modality. Several risk models based on clinical and angiographic variables have been developed to guide patient selection, each of which has significant limitations. This paper reviews contemporary and newly proposed risk models for patients undergoing left main stem revascularization.

Does off-pump coronary surgery reduce morbidity and mortality?

OBJECTIVE: To compare hospital outcomes of on-pump and off-pump coronary artery bypass surgery. METHODS: From 1997 to 2000, primary coronary artery bypass grafting was performed in 481 patients off pump and in 3231 patients on pump. Hospital outcomes were compared between propensity-matched pairs of 406 on-pump and 406 off-pump patients. The 2 groups were similar in age (P =.9), left ventricular function (P =.7), extent of coronary artery disease (P =.5), carotid artery disease (P =.4), and chronic obstructive pulmonary disease (P =.5). However, off-pump patients had more previous strokes (P =.05) and peripheral vascular disease (P =.02); on-pump patients had a higher preoperative New York Heart Association class (P =.01). RESULTS: In the matched pairs the mean number of bypass grafts was 2.8 +/- 1.0 in off-pump patients and 3.5 +/- 1.1 in on-pump patients (P <.001). Fewer grafts were performed to the circumflex (P <.001) and right coronary (P =.006) artery systems in the off-pump patients. Postoperative mortality, stroke, myocardial infarction, and reoperation for bleeding were similar in the 2 groups. There was more encephalopathy (P =.02), sternal wound infection (P =.04), red blood cell use (P =.002), and renal failure requiring dialysis (P =.03) in the on-pump patients. CONCLUSIONS: Both off- and on-pump procedures produced excellent early clinical results with low mortality. An advantage of an off-pump operation was less postoperative morbidity; however, less complete revascularization introduced uncertainty about late results. A disadvantage of on-pump bypass was higher morbidity that seemed attributable to cardiopulmonary bypass.