Biomedical subjects
Publications and source records attributed to H Schaff.
We report a case of postoperative intracardiac shunts across the membranous septum detected by Doppler echocardiography and discuss the anatomical basis for the development of such a complication.
BACKGROUND AND AIM OF THE STUDY: This article presents the protocol of the Artificial Valve Endocarditis Reduction Trial (AVERT), a multicenter, international randomized trial to assess the efficacy of the SilzoneTM coating of St. Jude Medical Masters Series mechanical heart valves in the prevention of prosthetic heart valve endocarditis (PVE). A total of 4,400 eligible patients will be randomized within three years of study commencement at 17 participating clinical centers in North America and Europe, with study completion within four years. ELIGIBILITY CRITERIA: Eligible patients are candidates for St. Jude mechanical valves with either the Silzone or conventional cuff, in the mitral and/or aortic position, who give informed written consent to participate. Major exclusion criteria are the presence of prosthetic valves that do not require replacement, and the need for tricuspid valve replacement. Bypass surgery and valve repair are allowed during the implant operation. Patients will be randomized using an envelope-based intraoperative randomization scheme, stratified by clinical center and by the presence of endocarditis at the time of surgery. FOLLOW UP: Patients will be contacted at discharge, three months, and each anniversary of the implant procedure. A brief follow up survey, administered via clinic interview, telephone or mail, will elicit events associated with possible endocarditis (unexplained fever, worsening angina, hospitalization) that will initiate contact with the patient's following physician. OUTCOME ANALYSIS: The primary PVE endpoint will be based upon a published algorithm, with two infectious disease specialists making the final determination of cases classified as possible endocarditis. Study data will be periodically reviewed by a Data Safety Monitoring Board. The primary analysis will be an intention-to-treat comparison of freedom from PVE curves between the Silzone and conventional cuff treatment groups. CONCLUSIONS: AVERT will provide much-needed information on the effectiveness of Silzone in preventing PVE, as well as practice patterns and outcomes of valve replacement.
OBJECTIVE: We examined the effects of aprotinin on graft patency, prevalence of myocardial infarction, and blood loss in patients undergoing primary coronary surgery with cardiopulmonary bypass. METHODS: Patients from 13 international sites were randomized to receive intraoperative aprotinin (n = 436) or placebo (n = 434). Graft angiography was obtained a mean of 10.8 days after the operation. Electrocardiograms, cardiac enzymes, and blood loss and replacement were evaluated. RESULTS: In 796 assessable patients, aprotinin reduced thoracic drainage volume by 43% (P < .0001) and requirement for red blood cell administration by 49% (P < .0001). Among 703 patients with assessable saphenous vein grafts, occlusions occurred in 15.4% of aprotinin-treated patients and 10.9% of patients receiving placebo (P = .03). After we had adjusted for risk factors associated with vein graft occlusion, the aprotinin versus placebo risk ratio decreased from 1.7 to 1.05 (90% confidence interval, 0.6 to 1.8). These factors included female gender, lack of prior aspirin therapy, small and poor distal vessel quality, and possibly use of aprotinin-treated blood as excised vein perfusate. At United States sites, patients had characteristics more favorable for graft patency, and occlusions occurred in 9.4% of the aprotinin group and 9.5% of the placebo group (P = .72). At Danish and Israeli sites, where patients had more adverse characteristics, occlusions occurred in 23.0% of aprotinin- and 12.4% of placebo-treated patients (P = .01). Aprotinin did not affect the occurrence of myocardial infarction (aprotinin: 2.9%; placebo: 3.8%) or mortality (aprotinin: 1.4%; placebo: 1.6%). CONCLUSIONS: In this study, the probability of early vein graft occlusion was increased by aprotinin, but this outcome was promoted by multiple risk factors for graft occlusion.
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BACKGROUND: Observational and randomized studies designed to compare surgical and medical therapies in patients with left main coronary artery disease (LMCD) have shown that coronary artery bypass graft (CABG) surgery prolongs life in most patients with LMCD. The present report of 1484 patients with LMCD in the Coronary Artery Surgery Study (CASS) Registry extends the originally published 5-year surgical and medical group survival analysis to more than 16 years of follow-up and permits analysis of LMCD patient subgroups. METHODS AND RESULTS: The CASS Registry contains 1484 patients with > or = 50% left main coronary artery stenosis initially treated with either surgical or nonsurgical therapy. The 15-year cumulative survival estimates were 37% for the 1153 patients in the surgical group compared with 27% for the 331 patients in the medical group. Median survival in the surgical group was 13.3 years (12.8 to 13.8 years, 95% confidence limits) compared with only 6.6 years (5.4 to 7.9 years) in the medical group (difference, 6.7 years; P < .0001). Median survival was also significantly longer in the surgical group stratified by age, sex, anginal class, left ventricular (LV) function, coronary anatomy, and the extent of LMCD. However, CABG surgery did not significantly prolong median survival in patient subgroups with (1) left main coronary stenosis of 50% to 59%; (2) normal LV systolic function; (3) normal or mildly abnormal LV systolic function and a right coronary artery stenosis > or = 70%; and (4) a nonstenotic (< or = 70%) right coronary artery. The 15-year cumulative survival for patients with normal LV systolic function in the surgical and medical groups was 42% and 51%, respectively. Median survival was 14.7 years in the surgical group and > 15 years in the medical group (P = NS). In patients with normal LV systolic function and a right coronary artery stenosis > or = 70%, the 15-year cumulative survival rates were also similar in the surgical and medical groups (40% and 48%, respectively). Median survival was 14.3 years in the surgical group and 14.2 years in the medical group (P = NS). The 15-year cumulative survival estimates for all subgroups were affected by convergence of the surgical and medical survival group curves owing to a disproportionate increase in the late surgical group mortality. Overall, 25% of patients in the medical group ultimately underwent CABG surgery. If all medical group patients had survived long enough, about 47% would be estimated to have had surgery by 15 years. CONCLUSIONS: This report, which extends follow-up of more than 16 years in CASS Registry patients with LMCD, shows that CABG surgery prolongs life in most clinical and angiographic subgroups. However, median survival was not prolonged by CABG surgery in patients with normal LV systolic function, even if a significant right coronary artery stenosis (> or = 70%) also was present. These results extend our understanding of the natural history of LMCD and permit a more accurate estimate of long-term surgical and medical group survival.
BACKGROUND: Combined severe proximal left anterior descending and proximal left circumflex coronary artery disease, or left main equivalent (LMEQ) disease, defines a prognostic high-risk angiographic subset of patients with chronic ischemic heart disease. While numerous observational and randomized clinical trials showed prolonged survival in surgically compared with medically treated patients with left main coronary artery disease, relatively few observational studies compared surgical and medical therapies in patients with LMEQ disease. The present report of 912 patients with LMEQ disease in the Coronary Artery Surgery Study (CASS) Registry extends the originally published 5-year surgical and medical group survival analysis to more than 16 years of follow-up and permits analysis of LMEQ patient subgroups. METHODS AND RESULTS: The CASS Registry contains 912 patients with LMEQ disease, defined as combined stenoses of > or = 70% in the proximal left anterior descending coronary artery before the first septal perforator and proximal circumflex coronary artery before the first obtuse marginal branch, initially treated with either surgical or nonsurgical therapy. The 15-year cumulative survival estimates were 44% for the 630 patients in the surgical group and 31% for the 282 patients in the medical group. Median survival in the surgical group was 13.1 years (12.7 to 14.1 years, 95% confidence limits) compared with only 6.2 years (4.8 to 7.9 years) in the medical group (difference, 6.9 years; P < .0001). Median survival was also significantly longer in the surgical group stratified by age, sex, anginal class, left ventricular (LV) function, and coronary anatomy. However, coronary artery bypass graft (CABG) surgery did not significantly prolong median survival in patient subgroups with (1) normal LV systolic function, even if a significant right coronary artery stenosis (> or = 70%) also was present, and (2) mildly abnormal (LV score, 6 to 10) LV systolic function. The 15-year cumulative survival in patients with normal LV systolic function in the surgical and medical groups was 63% and 54%, respectively. Median survival was > 15 years in both the surgical and medical groups (P = NS). In patients with normal LV systolic function and right coronary artery stenosis > or = 70%, the 15-year cumulative survival was also similar in the surgical and medical groups (63% and 53%, respectively). Median survival was > 15 years in both the surgical and medical groups (P = NS). The 15-year cumulative survival estimates in all subgroups were affected by convergence of the surgical and medical group survival curves caused by a disproportionate increase in late surgical group mortality. Overall, 26% of patients in the medical group ultimately underwent CABG surgery. If all medical group patients had survived long enough, about 65% would be estimated to have had surgery by 15 years. When the CASS Registry patients with LMEQ disease who participated in the randomized trial or who were randomizable were analyzed, CABG surgery did not prolong the 15-year cumulative survival estimates compared with nonsurgical therapy for randomized (71% versus 67%, respectively) and for randomizable patients (62% versus 92%, respectively) with an LV ejection fraction > or = 50%. CONCLUSIONS: This report, which extends follow-up of more than 16 years in CASS Registry patients with LMEQ disease, shows that CABG surgery prolongs life in most clinical and angiographic subgroups. However, median survival was not prolonged by CABG surgery in patients with normal LV systolic function, even if a significant right coronary artery stenosis (> or = 70%) also was present or in patients with an LV ejection fraction > or = 50% who participated in the CASS randomized trial or who were randomizable.
During the past 2 decades 102 consecutive patients (77 men and 25 women) with multiple aortic aneurysms underwent 201 aortic reconstructions. These procedures (174 elective and 27 emergent) represented 3.4% of the 5837 aortic aneurysm operations performed. Seventy-five (30.9%) of the 243 aneurysms occurred in the infrarenal aorta, 65 occurred in the descending aorta (26.7%), 56 occurred in the thoracoabdominal aorta (23.0%), and 47 occurred in the ascending aorta or arch (19.3%). Ages ranged from 20 to 81 years (mean 63.3 years). Smoking history and abnormal electrocardiographic tracings were present in 84.3% of the patients, hypertension was present in 77.5%, and obstructive lung disease was present in 60.8%. Multiple aortic aneurysms were present at the time of the first repair in 55 patients (53.9%). Twelve patients had one procedure, 81 had two, and nine had three. Sixteen (17.8%) of the 90 patients who had multiple operations had a subsequent operation for complications of the unrepaired aneurysm (rupture 12, symptoms 4). Fourteen perioperative deaths occurred among the 174 elective repairs (8.0%), and 11 occurred among the 27 emergent procedures (40.7%). Procedure mortality increased with the ordinal number of elective operations and was 4.4% for the first, 10.4% for the second, and 33.3% for the third. Seven of 21 patients (33.3%) who had simultaneous repair of at least two aortic aneurysms died in the perioperative period. Overall, 77 of the 102 patients (75.5%) survived all surgical procedures to repair their multiple aortic aneurysms; of these, 63 had complete resection of all known aneurysms. Follow-up was complete in all patients and averaged 6.3 years (ranges: 1 month to 19 years). There were 30 late deaths; the most frequent cause was myocardial infarction. Kaplan-Meier 5-year survival including perioperative deaths for all patients after the first operation was 76% and after the last operation 40%. We conclude that multiple aortic aneurysms can be safely managed, usually with staged repairs, and that long-term survival is probably. After the first aortic operation the presence of multiple aneurysms mandates close observation with timely surgical intervention.
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There are few data on the long-term effects of new Q waves on survival and morbidity after coronary bypass graft surgery (CABG). We followed 1340 patients who underwent CABG in 1978 at 10 hospitals participating in the Coronary Artery Surgery Study (CASS). The incidence of perioperative Q-wave infarction was 4.76% (range 0.0-10.3% by hospital). The rate of infarction was higher in patients who had an increased left ventricular end-diastolic pressure or cardiomegaly on the preoperative chest radiograph. Patients who received more grafts or who had longer cardiopulmonary bypass time were also at higher risk of infarction. In a stepwise discriminant analysis of 44 clinical, angiographic and surgical variables, cardiopulmonary bypass time, topical cardiac hypothermia and cardiomegaly entered the stepwise selection of variables. Long-term survival was adversely affected by the appearance of new postoperative Q waves. The hospital mortality was 9.7% in the 62 patients who had new postoperative Q waves and 1.0% in the 1278 patients who did not (p less than 0.001); the 3-year cumulative survival rates were 85% and 95%, respectively (p less than 0.001). In patients who survived to hospital discharge, the presence of new postoperative Q waves did not adversely affect 3-year survival (94% and 96%, respectively). The survival rates were worse in patients who had a history of infarction or who had impaired left ventricular function preoperatively. The number of readmissions to hospital after CABG among the patients who had a transmural perioperative infarction was similar to to that among patients who did not. We conclude that the appearance of new Q waves after CABG adversely affects survival. The major impact on mortality occurs before hospital discharge. Patients who are destined to have a perioperative infarct cannot be predicted from commonly measured preoperative and angiographic variables.
Left ventricular (LV) aneurysms were resected in 27 patients for treatment of congestive heart failure and in five patients for treatment of ventricular arrhythmia. There were eight early (25 per cent) and five late (15 per cent) deaths. Preoperative hemodynamics including analysis of left ventriculograms in the right anterior oblique position did not consistently predict survival. In contrast, coronary artery anatomy appeared to influence the mortality rate strikingly in patients with congestive heart failure. The hospital mortality rate was 6 per cent and the late mortality rate was 13 per cent for 16 patients with one-or two-vessel coronary artery disease, but with unobstructed LV lateral wall blood supply. All but one of the survivors obtained a good late result. In nine patients with two-and three-vessel coronary artery disease and obstructed LV lateral wall blood supply there were six hospital deaths and two late deaths. It is concluded that the presence or absence of occlusive disease in the arteries supplying the LV lateral wall is an important determinant of the mortality rate associated with resection of anterior apical LV aneurysms in patients with severe congestive heart failure.