Appropriate patient selection or health care rationing? Lessons from surgical aortic valve replacement in the Placement of Aortic Transcatheter Valves I trial.

OBJECTIVES: The study objectives were to (1) compare the safety of high-risk surgical aortic valve replacement in the Placement of Aortic Transcatheter Valves (PARTNER) I trial with Society of Thoracic Surgeons national benchmarks; (2) reference intermediate-term survival to that of the US population; and (3) identify subsets of patients for whom aortic valve replacement may be futile, with no survival benefit compared with therapy without aortic valve replacement. METHODS: From May 2007 to October 2009, 699 patients with high surgical risk, aged 84 ± 6.3 years, were randomized in PARTNER-IA; 313 patients underwent surgical aortic valve replacement. Median follow-up was 2.8 years. Survival for therapy without aortic valve replacement used 181 PARTNER-IB patients. RESULTS: Operative mortality was 10.5% (expected 9.3%), stroke 2.6% (expected 3.5%), renal failure 5.8% (expected 12%), sternal wound infection 0.64% (expected 0.33%), and prolonged length of stay 26% (expected 18%). However, calibration of observed events in this relatively small sample was poor. Survival at 1, 2, 3, and 4 years was 75%, 68%, 57%, and 44%, respectively, lower than 90%, 81%, 73%, and 65%, respectively, in the US population, but higher than 53%, 32%, 21%, and 14%, respectively, in patients without aortic valve replacement. Risk factors for death included smaller body mass index, lower albumin, history of cancer, and prosthesis-patient mismatch. Within this high-risk aortic valve replacement group, only the 8% of patients with the poorest risk profiles had estimated 1-year survival less than that of similar patients treated without aortic valve replacement. CONCLUSIONS: PARTNER selection criteria for surgical aortic valve replacement, with a few caveats, may be more appropriate, realistic indications for surgery than those of the past, reflecting contemporary surgical management of severe aortic stenosis in high-risk patients at experienced sites.

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.

Tricuspid regurgitation and right ventricular function after mitral valve surgery with or without concomitant tricuspid valve procedure.

OBJECTIVES: To study the effect of mitral valve repair with or without concomitant tricuspid valve repair on functional tricuspid regurgitation and right ventricular function. METHODS: From 2001 to 2007, 1833 patients with degenerative mitral valve disease, a structurally normal tricuspid valve, and no coronary artery disease underwent mitral valve repair, and 67 underwent concomitant tricuspid valve repair. Right ventricular function (myocardial performance index and tricuspid annular plane systolic excursion) was measured before and after surgery using transthoracic echocardiography for randomly selected patients with tricuspid regurgitation grade 0, 1+, and 2+ (100 patients for each grade) and 93 with grade 3+/4+, 393 patients in total. RESULTS: In patients with mild (<3+) preoperative tricuspid regurgitation, mitral valve repair alone was associated with reduced tricuspid regurgitation and mild worsening of right ventricular function. Tricuspid regurgitation of 2+ or greater developed in fewer than 20%, and right ventricular function had improved, but not to preoperative levels, at 3 years. In patients with severe (3+/4+) preoperative tricuspid regurgitation, mitral valve repair alone reduced tricuspid regurgitation and improved right ventricular function; however, tricuspid regurgitation of 2+ or greater returned and right ventricular function worsened toward preoperative levels within 3 years. Concomitant tricuspid valve repair effectively eliminated severe tricuspid regurgitation and improved right ventricular function. Also, over time, tricuspid regurgitation did not return and right ventricular function continued to improve to levels comparable to that of patients with lower grades of preoperative tricuspid regurgitation. CONCLUSIONS: In patients with mitral valve disease and severe tricuspid regurgitation, mitral valve repair alone was associated with improved tricuspid regurgitation and right ventricular function. However, the improvements were incomplete and temporary. In contrast, concomitant tricuspid valve repair effectively and durably eliminated severe tricuspid regurgitation and improved right ventricular function toward normal, supporting an aggressive approach to important functional tricuspid regurgitation.

Understanding right ventricular dysfunction and functional tricuspid regurgitation accompanying mitral valve disease.

OBJECTIVES: The study objective was to correlate the degree of tricuspid regurgitation with clinical indicators of right-sided heart failure and both qualitative and quantitative measures of right-sided heart morphology and function in patients with degenerative mitral valve disease. METHODS: From 2001 to 2007, 1833 patients with degenerative mitral valve disease, structurally normal tricuspid valve, and no coronary artery disease underwent surgery. Right-sided heart morphology (right ventricular base-to-apex length, tethering distance and area, and right atrial systolic area) and right ventricular function (tricuspid annular plane systolic excursion, myocardial performance index, and tricuspid valve annular shortening) were measured on preoperative transthoracic echocardiograms for 100 randomly selected patients from each of tricuspid regurgitation grades 0, 1+, and 2+, and for all 93 patients with tricuspid regurgitation grade 3+/4+. Multivariable regression was used to evaluate the association of left- and right-sided heart morphology and function with tricuspid regurgitation. RESULTS: Increasing tricuspid regurgitation grade was associated with higher right ventricular pressure (P < .0001), increased tethering distance (P = .008), larger right atrial size (P = .0002), and worsening right ventricular function, particularly when 3+/4+ tricuspid regurgitation was present. When tricuspid regurgitation was 3+/4+, both tricuspid annular plane systolic excursion and myocardial performance index were almost certainly abnormal. Changes in right-sided heart morphology and right ventricular dysfunction were synergistic in relation to severity of tricuspid regurgitation. CONCLUSIONS: Functional tricuspid regurgitation accompanying mitral valve disease is associated with proportional changes in right-sided heart morphology; however, severe tricuspid regurgitation is nearly always associated with right ventricular dysfunction, suggesting a synergistic relationship. Right ventricular dysfunction is likely as important as tricuspid regurgitation because it offers an explanation for the negative prognostic impact of tricuspid regurgitation and has implications for the clinical management of patients.

Decision support in surgical management of ischemic cardiomyopathy.

OBJECTIVES: The surgical approach to ischemic cardiomyopathy maximizing survival remains a dilemma, with decisions complicated by secondary mitral regurgitation, ventricular remodeling, and heart failure. As a component of decision support, we sought to develop prediction models for comparing survival after coronary artery bypass grafting alone, coronary artery bypass grafting plus mitral valve anuloplasty, coronary artery bypass grafting plus surgical ventricular restoration, and listing for cardiac transplantation. METHODS: From 1997 to 2007, 1468 patients with ischemic cardiomyopathy (ejection fraction <30%) underwent coronary artery bypass grafting alone (n = 386), coronary artery bypass grafting plus mitral valve anuloplasty (n = 212), coronary artery bypass grafting plus surgical ventricular restoration (n = 360), or listing for cardiac transplantation (n = 510). Mean follow-up was 3.8 +/- 2.8 years, with 5577 patient-years of data available for analysis. Risk factors were identified for early and late mortality by using 80% training and 20% validation sets. Outcomes were calculated for each applicable strategy to identify which maximized predicted 5-year survival. Models were programmed as a strategic decision-support tool. RESULTS: One-, 5-, and 9-year survival were as follows, respectively: coronary artery bypass grafting, 92%, 72%, and 53%; coronary artery bypass grafting plus mitral valve anuloplasty, 88%, 57%, and 34%; coronary artery bypass grafting plus surgical ventricular restoration, 94%, 76%, and 55%; and listing for cardiac transplantation, 79%, 66%, and 54%. Risk factors included older age, higher New York Heart Association class, lower ejection fraction, longer interval from myocardial infarction to operation, and numerous comorbidities. Predicted and observed survivals in validation groups were similar (P > .1). Patient-specific simultaneous solutions of applicable models revealed therapy potentially providing maximum survival benefit. Coronary artery bypass grafting alone and listing for cardiac transplantation often maximized 5-year survival; only 15% of patients undergoing coronary artery bypass grafting plus mitral valve anuloplasty were predicted to fare best with this therapy. CONCLUSION: Validated prediction models can aid surgeons in recommending personalized treatment plans that maximize short- and long-term survival for ischemic cardiomyopathy.

Tracheostomy after cardiovascular surgery: an assessment of long-term outcome.

OBJECTIVE: To ascertain long-term survival, identify risk factors for death, and document complications of tracheostomy after cardiovascular surgery. METHODS: Between January 1, 1998, and September 1, 2001, 188 (1.4%) of 13,191 patients undergoing cardiovascular surgery had tracheostomy for respiratory failure 5 to 79 days (median, 14 days) after surgery. Factors associated with mortality were identified in the hazard function domain, and mode of death and complications of tracheostomy were determined by follow-up. RESULTS: Survival was 75%, 50%, and 31% at 30 days, 3 months, and 2 years, respectively. The most important risk factors for death were older age (P = .004) and variables representing deteriorating hemodynamic (P < .0001), respiratory (P < .0001), and renal (P = .0001) function between the index cardiovascular operation and tracheostomy. The mode of death was isolated respiratory failure in only 21 (16%) of 130 patients, but multisystem organ failure in 71 (55%). Follow-up of 58 survivors identified voice complaints in 13 (24%), tracheal stenosis in 5 (9.2%), and permanent tracheostomy in 3 (6%). CONCLUSIONS: Only one third of patients undergoing tracheostomy after cardiovascular surgery survive, because it is used primarily in those with deteriorating function of multiple organ systems. Although tracheostomy may enhance patient comfort and simplify nursing care, selection algorithms need to be developed if survival is the goal of the intervention.