Competing risks after coronary bypass surgeryThe influence of death on reintervention

AbstractObjective: For groups of patients at high risk of death, such as older patients, the actual probability of experiencing a nonfatal event, such as reintervention, must be far smaller than the potential probability were there no attrition by death. Competing risks analysis quantifies the difference. Methods: Multivariable analyses were performed for the competing events death before reintervention, reoperation, and percutaneous transluminal coronary angioplasty in 2001 patients after bilateral internal thoracic artery grafting and in 8123 after single internal thoracic artery grafting. Follow-up was 9.7 ± 3.0 years and 10.8 ± 5.2 years in bilateral and single internal thoracic artery groups, respectively. Results: Patients receiving single grafts experienced shorter survival and more reinterventions (P < .0001). However, other risk factors for death included old age (P < .0001), but risk factors for reintervention included young age (P < .0001). This difference confounds interpretation of event-free survival that is clarified by competing risks analysis. Death reduced the potential benefit of bilateral internal thoracic artery grafting on reintervention by angioplasty from a median of 8.5% to 5.5% at 12 years and by reoperation from 9.3% to 6.8%, with progressively greater erosion of benefit from attrition by death as age increased. Competing risks simulation confirmed that young age was a true risk factor for reintervention, excluding the explanation that it reflected simply passive attrition by death as patients age. Conclusions: Even after accounting for attrition by interim deaths, bilateral versus single internal thoracic artery grafting and older age are associated with fewer reinterventions. However, in high-risk patients, its benefit on freedom from reintervention is eroded considerably by death. (J Thorac Cardiovasc Surg 2000;119:1221-32

Exercise Echocardiography in Asymptomatic HCM Exercise Capacity, and Not LV Outflow Tract Gradient Predicts Long-Term Outcomes

ObjectivesThis study sought to assess long-term outcomes in asymptomatic or minimally symptomatic patients with hypertrophic cardiomyopathy (HCM) who underwent exercise echocardiography, without invasive therapies for relief of left ventricular outflow tract (LVOT) obstruction.BackgroundMany HCM patients present with LVOT obstruction, mitral regurgitation (MR), and diastolic dysfunction, often requiring invasive therapies for symptomatic relief. However, a significant proportion of truly asymptomatic patients can be closely monitored. In HCM patients, exercise echocardiography has been shown to be a useful assessment of functional capacity and risk stratification.MethodsWe included 426 HCM patients (44 ± 14 years; 78% men) undergoing exercise echocardiography, excluding hypertensive heart disease of elderly, ejection fraction <50% and invasive therapy (myectomy or alcohol ablation) during follow-up. Clinical, echocardiographic (LV thickness, LVOT gradient, and MR) and exercise variables (percent of age-sex predicted metabolic equivalents [METs] and heart rate recovery [HRR] at 1 min post-exercise) were recorded. A composite endpoint of death, appropriate internal defibrillator discharge, and admission for congestive heart failure was recorded.ResultsPatients were asymptomatic or minimally symptomatic on history, but 82% of patients achieved <100% of age-sex predicted METs, and 43% had ≥II+ post-stress MR. The mean LV septal thickness, post-exercise LVOT gradient, and HRR were 2.0 ± 0.5 cm, 62 ± 47 mm Hg, and 31 ± 14 beats/min, respectively. During a mean follow-up of 8.7 ± 3 years, there were 52 events (12%). Patients achieving >100% of age-sex predicted METs had 1% event rate versus 12% in those achieving <85%. On stepwise multivariate survival analysis, percent of age-sex predicted METs (hazard ratio [HR]: 0.76; 95% confidence interval [CI]: 0.64 to 0.90), abnormal HRR (HR: 0.89; 95% CI: 0.82 to 0.97), and atrial fibrillation (HR: 2.73; 95% CI: 1.30 to 5.74) (overall, p < 0.001) independently predicted outcomes.ConclusionsIn asymptomatic or minimally symptomatic HCM patients, exercise stress testing provides excellent risk stratification, with a low event rate in patients achieving >100% of predicted METs

A comprehensive review of the PARTNER trial

ObjectivePercutaneous transcatheter aortic valve replacement was introduced in 2002, but its effectiveness remained to be assessed.MethodsA 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 cm2, gradient >40 mm Hg or peak >64 mm Hg, and survival >1 year. The end point of the study was 1-year mortality.ResultsThirty-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.ConclusionsThe PARTNER A and B trials showed that survival has been remarkably good, but stroke and perivalvular leakage require further device development

Surgical treatment of prosthetic valve endocarditis

AbstractFrom 1975 through 1992, we reoperated on 146 patients for the treatment of prosthetic valve endocarditis. Prosthetic valve endocarditis was considered to be early (<1 year after operation) in 46 cases and active in 103 cases. The extent of the infection was prosthesis only in 66 patients, anulus in 46, and cardiac invasion in 34. Surgical techniques evolved in the direction of increasingly radical débridement of infected tissue and reconstruction with biologic materials. All patients were treated with prolonged postoperative antibiotic therapy. There were 19 (13%) in-hospital deaths. Univariate analyses demonstrated trends toward increasing risk for patients with active endocarditis and extension of infection beyond the prosthesis; however, the only variables with a significant (p < 0.05) association with increased in-hospital mortality confirmed with multivariate testing were impaired left ventricular function, preoperative heart block, coronary artery disease, and culture of organisms from the surgical specimen. During the study period, mortality decreased from 20% (1975 to 1984) to 10% (1984 to 1992). For hospital survivors the mean length of stay was 25 days. Follow-up (mean interval 62 months) documented a late survival of 82% at 5 postoperative years and 60% at 10 years. Older age was the only factor associated (p = 0.006) with late death. Nineteen patients needed at least one further operation; reoperation-free survival was 75% at 5 and 50% at 10 postoperative years. Fever in the immediate preoperative period was the only factor associated with decreased late reoperation-free survival (p = 0.032). Prosthetic valve endocarditis remains a serious complication of valve replacement, but the in-hospital mortality of reoperations for prosthetic valve endocarditis has declined. With extensive débridement of infected tissue and postoperative antibiotic therapy, the extent and activity of prosthetic valve endocarditis does not appear to have a major impact on late outcome, and the majority of patients with this complication survive for 10 years after the operation. (J THORAC CARDIOVASC SURG 1996;111:198-210

Adverse events during reoperative cardiac surgery: Frequency, characterization, and rescue

ObjectivesTo (1) determine frequency of occurrence and risk factors for intraoperative adverse events (IAE) during reoperative cardiac surgery, (2) characterize them with respect to structure injured, timing, and use of preventive strategies, and (3) identify the impact on outcome in terms of successful and unsuccessful rescue and cost.MethodsOperative notes of 1847 patients undergoing reoperative cardiac surgery were reviewed to identify and characterize documented intraoperative adverse events. Logistic regression modeling was used to identify risk factors for intraoperative adverse events and outcomes. Expected versus observed poor outcomes (stroke, myocardial infarction, death) was used to measure rescue.ResultsAmong 127 patients, 145 (7%) intraoperative adverse events occurred. These included injuries to bypass grafts (n = 47), heart (n = 38), and great vessels (n = 28) and ischemia without graft injury (n = 22). Most occurred on opening (n = 34, 23%) and during prebypass dissection (n = 57, 39%). Risk incremented as reoperations increased. Seventy-seven patients experienced 1 or more lapses in preventive strategies. Patients with intraoperative adverse events had a greater number of poor outcomes (n = 24 [19%] vs n = 107 [6.2%]; P < .0001) and incurred higher direct technical intraoperative and postoperative costs (ratio 1.3). Twelve patients with intraoperative adverse events were predicted to have poor outcomes versus 24 who did (P < .0001), indicating 12 “failures to rescue.”ConclusionsAdverse events still occur regularly during cardiac reoperation, are related to complexity of the procedure, and occur particularly during dissection and often when preventive strategies have not been used. Compensatory rescue measures are not always successful. Adverse events lead to poor patient outcome and higher cost

Severe Aortic Stenosis and Coronary Artery Disease—Implications for Management in the Transcatheter Aortic Valve Replacement Era A Comprehensive Review

Management of coronary artery disease (CAD) in patients with severe aortic stenosis (AS) referred for transcatheter aortic valve replacement (TAVR) is posing challenges. Due to limited and heterogeneous data on the prevalence and clinical impact of CAD on the outcomes of TAVR and the management strategies for CAD in patients undergoing TAVR, we performed a comprehensive review of the literature. Significant CAD is present in 40% to 75% of patients undergoing TAVR. The impact of CAD on outcomes after TAVR remains understudied. Based on existing data, not all patients require revascularization before TAVR. Percutaneous coronary intervention (PCI) should be considered for severely stenotic lesions in proximal coronaries that subtend a large area of myocardium at risk. Ongoing studies randomizing patients to surgical or percutaneous management strategies for severe AS will help provide valuable data regarding the impact of CAD on TAVR outcomes, the role of PCI, and its timing in relation to TAVR

Outcomes of less invasive J-incision approach to aortic valve surgery

ObjectiveLess invasive approaches to aortic valve surgery are increasingly used; however, few studies have investigated their impact on outcome. We sought to compare clinical outcomes after these approaches with full sternotomy using propensity-matching methods.MethodsFrom January 1995 to January 2004, a total of 2689 patients underwent isolated aortic valve surgery, 1193 via upper J-hemisternotomy and 1496 via full sternotomy. Because of important differences in patient characteristics between these groups, a propensity score based on 42 variables was used to obtain 832 well-matched patient pairs (70% of possible cases).ResultsIn-hospital mortality was identical for propensity-matched patients, 0.96% (8 in each). Occurrences of stroke (P > .9), renal failure (P = .8), and myocardial infarction (P = .7) were similar. However, 24-hour mediastinal drainage was a third less after less invasive surgery (median, 250 vs 350 mL; P < .0001), and fewer patients received transfusions (24% vs 34%; P < .0001). More patients undergoing less invasive surgery were extubated in the operating room (12% vs 1.6%; P < .0001), postoperative forced 1-second expiratory volume was higher (P = .009), and fewer had respiratory failure (P = .01). Early after operation, pain scores were lower (P < .0001) after less-invasive surgery and postoperative length of stay shorter (P < .0001).ConclusionsWithin that portion of the spectrum of isolated aortic valve surgery where propensity matching was possible, minimally invasive aortic valve surgery had not only cosmetic advantages, but blood product use, respiratory, pain, and resource utilization advantages over full sternotomy, and no apparent detriments. Less invasive aortic valve surgery should be considered for most aortic valve operations