Rick Esposito

Percutaneous Coronary Intervention Versus Coronary Artery Bypass Graft Surgery for Patients With Medically Refractory Myocardial Ischemia and Risk Factors for Adverse Outcomes With Bypass: A Multicenter, Randomized Trial

Abstract BACKGROUND Percutaneous coronary intervention (PCI) and coronary artery bypass graft surgery (CABG) are being applied to high-risk populations, but previous randomized trials comparing revascularization methods have excluded a number of important high-risk groups. OBJECTIVES This five-year, multicenter, randomized clinical trial was designed to compare long-term survival among patients with medically refractory myocardial ischemia and a high risk of adverse outcomes assigned to either a CABG or a PCI strategy, which could include stents. METHODS Patients from 16 Veterans Affairs Medical Centers were screened to identify myocardial ischemia refractory to medical management and the presence of one or more risk factors for adverse outcome with CABG, including prior open-heart surgery, age >70 years, left ventricular ejection fraction RESULTS A total of 232 patients was randomized to CABG and 222 to PCI. The 30-day survivals for CABG and PCI were 95% and 97%, respectively. Survival rates for CABG and PCI were 90% versus 94% at six months and 79% versus 80% at 36 months (log-rank test, p = 0.46). CONCLUSIONS Percutaneous coronary intervention is an alternative to CABG for patients with medically refractory myocardial ischemia and a high risk of adverse outcomes with CABG.

Minimally invasive mitral valve surgery: a 6-year experience with 714 patients.

BACKGROUND This study analyzes a single institutional experience with minimally invasive mitral valve operations of 6 years, reviewing short-term morbidity and mortality and long-term echocardiographic follow-up data. METHODS Seven hundred fourteen consecutive patients had minimally invasive mitral valve procedures between November 1995 and November 2001; concomitant procedures included 91 multiple valves and 18 coronary artery bypass grafts. Of these 714 patients, 561 patients had isolated mitral valve operations (375 repairs, 186 replacements). Mean age was 58.3 years (range, 14 to 96 years; 30.1% > 70 years), and 15.4% of patients had previous cardiac operations. Arterial cannulation was femoral in 79.0% and central in 21%, with the port access balloon endo-occlusion used in 82.3%. Cardioplegia was transjugular retrograde (54.1%) or antegrade (29.4%). Right anterior minithoracotomy was used in 96.6% and left posterior minithoracotomy in 2.2%. RESULTS Hospital mortality for primary isolated mitral valve repair was 1.1% and 5.8% for isolated mitral valve replacement. Overall hospital mortality was 4.2% (30 of 714). Mean cross-clamp time was 92 minutes and mean cardiopulmonary bypass time was 127 minutes. Postoperatively, median ventilation time was 11 hours, intensive care unit time was 19 hours, and total hospital stay was 6 days. Complications for all patients included permanent neurologic deficit (2.9%), aortic dissection (0.3%); there was no mediastinal infection (0.0%). Follow-up echocardiography demonstrated 89.1% of the repair patients had only trace or no residual mitral insufficiency. CONCLUSIONS This study demonstrates that the minimally invasive port access approach to mitral valve operations is reproducible with low perioperative morbidity and mortality and with late outcomes that are equivalent to conventional operations.

Surgical implications of transesophageal echocardiography to grade the atheromatous aortic arch

Stroke is an especially serious complication of cardiopulmonary bypass with an incidence of 2% to 5%. This prospective study used transesophageal echocardiography (TEE) in 97 patients more than 65 years of age (mean age, 73 years) to identify those at high risk for aortic atheroemboli. The atheromatous disease of the aorta was graded by TEE: grade I = minimal intimal thickening (n = 29); II = extensive intimal thickening (n = 33); III = sessile atheroma (n = 15); IV = protruding atheroma (n = 10); V = mobile atheroma (n = 10). Clinical evaluation was also performed by intraoperative aortic palpation. Four patients who were graded as having normal aortas by palpation had intraoperative strokes. In contrast, 3 of these 4 patients were in grade V on TEE. The relationship of TEE to incidence of stroke was statistically significant (p less than 0.006), whereas there was no significant correlation between clinical grade and stroke incidence. Four of 10 TEE grade V patients were treated with hypothermic circulatory arrest and aortic arch debridement, and none suffered strokes. The other 6 patients were treated with standard techniques, and 3 had strokes. These results suggest that patients with mobile atheromatous disease are at high risk for embolic strokes that are not predicted by routine clinical evaluation. Selective use of circulatory arrest in the presence of TEE-detected mobile arch atheromas may reduce the risk of intraoperative stroke.

AORTIC VALVE REPLACEMENT FOR AORTIC STENOSIS IN PERSONS AGED 80 YEARS AND OVER

Seventy-one patients aged greater than or equal to 80 years (mean +/- standard deviation 82 +/- 2) with aortic stenosis or mixed stenosis and regurgitation underwent aortic valve replacement alone (n = 35, group 1) or in combination with a coronary artery bypass procedure without any other valve procedure (n = 36, group 2). Preoperatively, 91% had severe cardiac limitations (New York Heart Association class III or IV). Hospital mortality was 12.7% overall (9 of 71), 5.7% (2 of 35) for group 1 and 19.4% (7 of 36) for group 2. Perioperatively, 1 patient (1.4%) had a stroke. Survival from late cardiac death at 1 and 3 years was 98.2 and 95.5%, respectively, for all patients, 100% for patients who underwent isolated aortic valve replacement, and 96.3 and 91.2%, respectively, for patients who underwent aortic valve replacement plus coronary artery bypass. Eighty-three percent of surviving patients had marked symptomatic improvement. Freedom from all valve-related complications (thromboembolism, anticoagulant, endocarditis, reoperation or prosthetic failure) was 93.3 and 80.4% at 1 and 3 years, respectively. Thus, short- and long-term morbidity and mortality after aortic valve replacement for aortic stenosis in patients aged greater than or equal to 80 years are encouragingly low, although the addition of coronary artery bypass grafting increases short- and long-term mortality.

Racial differences in performance of invasive cardiac procedures in a Department of Veterans Affairs Medical Center

Racial differences have recently been described in hospital practice, most notably with regard to cardiac procedure utilization. To evaluate the possible reasons behind these differences, we analyzed statistics generated from a surgical referral conference at a large, tertiary care Veterans Affairs hospital between the years 1988 and 1996. In this setting, there is no financial incentive for physicians to recommend or perform invasive procedures, as all physicians are salaried employees of the Veterans Administration. Furthermore, all patients presented at conference have already had cardiac catheterization and are felt to be potential candidates for surgery or angioplasty. Cardiac therapeutic procedures (surgery or percutaneous transluminal coronary angioplasty) were recommended for 1075 of 1474 (72.9%) Caucasian patients and 207 of 322 (64.3%) African-American patients (odds ratio 1.497, 95% confidence interval 1.160 to 1.932, p = 0.0022). Of those patients presented with the option of an invasive procedure, 32 of 207 (15.4%) African-American patients and 89 of 1075 (8.3%) Caucasian patients refused any invasive procedure (odds ratio 2.026, 95% confidence interval 1.311 to 3.130, p = 0.0025). We conclude that reluctance by African-American patients to undergo invasive cardiac procedures may help explain observed disparities in race-related cardiac care.

Percutaneous coronary intervention versus repeat bypass surgery for patients with medically refractory myocardial ischemia: AWESOME randomized trial and registry experience with post-CABG patients

OBJECTIVES This report compares long-term percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) survival among post-CABG patients included in the Angina With Extremely Serious Operative Mortality Evaluation (AWESOME) randomized trial and prospective registry. BACKGROUND Repeat CABG surgery is associated with a higher risk of mortality than first-time CABG. The AWESOME is the first randomized trial comparing CABG with PCI to include post-CABG patients. METHODS Over a five-year period (1995 to 2000), patients at 16 hospitals were screened to identify a cohort of 2,431 individuals who had medically refractory myocardial ischemia and at least one of five high-risk factors. There were 454 patients in the randomized trial, of whom 142 had prior CABG. In the physician-directed registry of 1,650 patients, 719 had prior CABG. Of the 327 patient-choice registry patients, 119 had at least one prior CABG. The CABG and PCI survivals for the three groups were compared using Kaplan-Meier curves and log-rank tests. RESULTS The CABG and PCI three-year survival rates were 73% and 76% respectively for the 142 randomized patients (75 and 67 patients) (log-rank = NS). In the physician-directed registry, 155 patients were assigned to reoperation and 357 to PCI (207 received medical therapy); 36-month survivals were 71% and 77% respectively (log-rank = NS). In the patient-choice registry, 32 patients chose reoperation and 74 chose PCI (13 received medical therapy); 36-month survivals were 65% and 86% respectively (log-rank test p = 0.01). CONCLUSIONS Percutaneous coronary intervention is preferable to CABG for many post-CABG patients.

Percutaneous coronary intervention versus coronary bypass graft surgery for diabetic patients with unstable angina and risk factors for adverse outcomes with bypass: Outcome of diabetic patients in the AWESOME randomized trial and registry

OBJECTIVES This study compared survival after percutaneous coronary intervention (PCI) with survival after coronary artery bypass graft surgery (CABG) among diabetics in the Veterans Affairs AWESOME (Angina With Extremely Serious Operative Mortality Evaluation) study randomized trial and registry of high-risk patients. BACKGROUND Previous studies indicate that CABG may be superior to PCI for diabetics, but no comparisons have been made for diabetics at high risk for surgery. METHODS Over five years (1995 to 2000), 2,431 patients with medically refractory myocardial ischemia and at least one of five risk factors (prior CABG, myocardial infarction within seven days, left ventricular ejection fraction <0.35, age >70 years, or an intra-aortic balloon being required to stabilize) were identified. A total of 781 were acceptable for CABG and PCI, and 454 consented to be randomized. The 1,650 patients not acceptable for both CABG and PCI constitute the physician-directed registry, and the 327 who were acceptable but refused to be randomized constitute the patient-choice registry. Diabetes prevalence was 32% (144) among randomized patients, 27% (89) in the patient-choice registry, and 32% (525) in the physician-directed registry. The CABG and PCI survival rates were compared using Kaplan-Meier curves and log-rank tests. RESULTS The respective CABG and PCI 36-month survival rates for diabetic patients were 72% and 81% for randomized patients, 85% and 89% for patient-choice registry patients, and 73% and 71% for the physician-directed registry patients. None of the differences was statistically significant. CONCLUSIONS We conclude that PCI is a relatively safe alternative to CABG for diabetic patients with medically refractory unstable angina who are at high risk for CABG.

The Effect of Pericardial Insulation on Hypothermic Phrenic Nerve Injury During Open-Heart Surgery

Phrenic nerve injury was evaluated prospectively in 133 patients undergoing open-heart surgery using iced saline slush for topical hypothermia. In the control group of 70 patients no attempt was made to shield the phrenic nerves from direct exposure to ice. Phrenic nerve damage occurred in 73% of these patients, as assessed by persistent diaphragm paralysis evident on inspiratory chest roentgenogram. In 2 patients the paralysis was bilateral. In the second group of 63 patients a pericardial insulation pad was used to prevent contact of the iced slush to the phrenic nerve. Diaphragm paralysis was observed in 17% of these patients. This difference was highly significant (p less than .001). Diaphragm paralysis in the control group was clinically significant; life-threatening respiratory complications developed in 7 patients (14%), frequently resulting in multiple reintubations, tracheostomy, and prolonged mechanical ventilation. In addition, 4 patients with phrenic nerve injury exhibited a clinical syndrome consistent with gastric ileus, which may possibly represent hypothermic injury to the thoracic vagi. The likelihood of phrenic nerve injury when iced saline slush is used for topical myocardial cooling and the possibility of developing serious respiratory disability would support the routine use of pericardial insulation when this method of hypothermia is used.

Valve Repair Versus Replacement For Mitral Insufficiency: When Is A Mechanical Valve Still Indicated?

OBJECTIVES Although many advantages of mitral valve reconstruction have been demonstrated, whether specific subgroups of patients exist in whom mechanical valve replacement offers advantages over mitral reconstruction remains undetermined. METHODS This study examined the late results of mitral valve surgery in patients with mitral insufficiency who received either a St. Jude Medical valve (n = 514) or a mitral valve reconstruction with ring annuloplasty (n = 725) between 1980 and 1996. RESULTS Overall operative mortality was 7.2% in the patients receiving a St. Jude Medical mitral valve and 5.4% in those undergoing mitral valve reconstruction (no significant difference); isolated mortality was 2.5% in the St. Jude Medical group and 2.2% in the valve reconstruction group (no significant difference). The follow-up interval was more than 5 years for 340 patients with a mean of 39.8 months (98.5% complete). Overall 8-year freedom from late cardiac death, reoperation, and all valve-related complications was 72.8% for the St. Jude Medical group and 64.8% for valve reconstruction group (no significant difference). For patients with isolated, nonrheumatic mitral valve disease, 8-year freedom from late cardiac death and reoperation was better in the mitral valve reconstruction group (88.3%) than in the St. Jude Medical valve group (86.0%; p = 0.05). Furthermore, Cox proportional hazards regression revealed that mitral valve reconstruction was independently associated with a lesser incidence of late cardiac death (p = 0.04), irrespective of preoperative New York Heart Association class. However, the St. Jude Medical valve offered better 8-year freedom from late cardiac death, reoperation, and all valve-related complications than did mitral valve reconstruction in patients with multiple valve disease (77.0% vs 45.3%; p < 0.01). CONCLUSIONS Therefore, mitral valve reconstruction appears to be the procedure of choice for isolated, nonrheumatic disease, whereas insertion of a St. Jude Medical valve should be preferred for patients with multiple valve disease.

Ten-year experience with aortic valve replacement in 482 patients 70 years of age or older: Operative risk and long-term results

A retrospective analysis of an institutional experience with aortic valve replacement (AVR) in patients 70 years of age or older during 1976 to 1987 was performed. The study was prompted in part by the current interest in palliative aortic valvoplasty, an interest based to a certain extent on the impression that AVR in the elderly has a high mortality. The mean age of the patients was 75.0 +/- 4.0 years (+/- the standard deviation) (range, 70 to 89 years). Eighty-three percent of patients received porcine valves and 17%, mechanical valves. Preoperatively 32% were in New York Heart Association class III, and 59% were in class IV. Operative mortality was 5.6% for elective isolated AVR for aortic stenosis (19% of all patients), 8.2% for all isolated AVR (38%), and 12.4% overall. Concomitant operative procedures were done in 62.0%; AVR with coronary artery bypass grafting (42%) had an operative mortality of 14.3%. Multivariate analysis showed significant predictors of operative mortality to be emergency operation (p less than 0.01), isolated aortic regurgitation (p = 0.01), and previous cardiac operation (p = 0.02). Follow-up (34 +/- 27 months) was 94% complete. Five-year survival from late cardiac-related death was 81.0%. The constant yearly hazard rate for late death for patients 70 years of age or older who underwent AVR was 5.42% per year, which is similar to the 5.77% per year rate calculated for age-matched and sex-matched controls. Five-year freedom from reoperation was 99%; from late thromboembolic complications, 91%; and from late anticoagulant-related complications, 94%. Freedom from all valve-related morbidity and mortality was 61% at 5 years.(ABSTRACT TRUNCATED AT 250 WORDS)