Standards for evaluating surgical therapy.
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Biomedical subjects
Publications and source records attributed to T Takaro.
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We evaluated the effect of saphenous-vein-bypass grafting on survival in patients with chronic stable angina by comparing medical and surgical treatment in a large-scale, prospective randomized study. Excluding patients with left-main-coronary-artery disease who have already been reported, a total of 596 patients were entered into this study; when randomized into a medical group (310 patients) and a surgical group (286 patients), entry clinical and angiographic base lines were comparable. Operative mortality at 30 days was 5.6 per cent. At an average of one year after operation, 69 per cent of all grafts were patent, and 88 per cent of the surgical patients had atleast one patent graft. There was no statistically significant difference in survival, at a minimal follow-up interval of 21 months, between patients treated medically and those treated with saphenous-vein-bypass grafting. At 36 months, 87 per cent of the medical group and 88 per cent of the surgical group were alive.
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Aortography, regarded as a definite diagnostic study in evaluating pateints with peripheral vascular occlusive disease, is usually done in the anteroposterior projection only. Occasionally, a significantly diseased area may not be identified on this projection, and an oblique view of the aortoiliac region may clarify the presence and severity of arteriosclerosis. At present, our indications for obtaining oblique views of the aortoiliac region are (1) when symptoms correlate poorly with the arteriographic findings in the anteroposterior projection, or (2) when the severity of the lesion is in doubt. These projections also are used to evaluate patients who have had previous aortoiliac bypass grafts and in whom ischemic symptoms recur. Patients with unilateral limb ischemia who are being considered for femorofemoral bypass graft procedures or iliac endarterectomy are also appropriate candidates, especially when radiopaque material overlies the vessels. Arteriograms in oblique projections also are recommended for more precise evaluation of the origin of the profunda femoris artery.
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The DeBakey-Surgitool aortic valve differs from popular cloth-covered prostheses by having a bare metal cage and a pyrolytic carbon ball. This valve was implanted in 37 patients. There were 7 operative deaths (19%), none of which was related to the valve design. Thirty survivors have been followed up to five years with 12 late deaths. The single thromboembolic event resulted in the only valve-related death. One patient developed a periprosthetic leak and another has hemolytic anemia. The incidence of thromboembolism in small series (3%) is comparable to that with the cloth-covered valves. This and the absence of complications related to cloth wear are important considerations when selecting a prosthesis.
Reoperation was performed in seven (16%) of 43 patients with early models of Magovern sutureless aortic valve prostheses, because of thromboembolism and ball variance. All patients survived reoperation with no major complications. Removal of the sutureless prosthesis was not difficult when an insertion tool of proper size was used. A scarred annulus remained which was favorable for the suturing of a new prosthesis. The incidence of disabling thromboembolism (42%) and poppet failure (21%) is high with these early models. When these complications occur, replacement of the prosthesis is recommended to prevent death or recurrent embolic episodes.
A large scale, prospective, randomized study of surgical v. medical management of disabling angina pectoris is being conducted as a cooperative study among thirteen Veterans Administration hospitals in the U.S.A. A total of 1015 patients have been entered into the study and follow-up data are currently being evaluated. Patient entry into the study was concluded in December 1974. Patient compliance has been acceptable with only 7% of patients not adhering to their randomization category. Thirty-day operative mortality (1972-1974) in 309 patients was 5-3%. The patient population exhibited a severe degree of coronary disease. There was ECG evidence of prior myocardial infarction in 40%. There were significant obstructive lesions in three major coronary arteries in 51% and significant lesions of the left main coronary artery in 11%. Medical and surgical treatment groups demonstrated no significant differences in objective descriptive characteristics. Mortality in the medical group at 1 year was 8%. Mortality was influenced by several factors including the number of vessels involved, left ventricular function and the presence of left main coronary artery disease. The lowest mortality occurred in patients with single vessel disease and normal LV function who had a 1-year mortality of 3%. Patients with 3-vessel disease and abnormal LV function exhibited a 14% 1-year mortality. Patients with disease of the left main coronary artery and poor LV function had a 1-year mortality of 37%. Analyses of the results of treatment modalities in sub-groups is currently being performed and will be reported in future publications.
The late results of renal transplantation are very encouraging. Apart from the more common complications, such as the rejection phenomenon and recurrent infections, occasionally renovascular hypertension may occur as a late complication. This is, to our knowledge, the first reported case of acute dissecting aortic aneurysm in a young man who had received a renal transplant six years earlier and later developed renovascular hypertension. All patients with renal transplant who develop severe hypertension which is refractory to medical management should be considered for renal arteriogaphy and correction of stenosis, if it is present.
From a large cooperative prospective randomized study, data relating to a subgroup of 113 patients with angina pectoris and a significant lesion of the left main coronary artery were analyzed. Of these patients, 53 had been randomly allocated to a medical treatment group and 60 to a surgical treatment group. The former group received conventional medical treatment, while the surgical treatment group received one or more aortocoronary saphenous vein bypass grafts. Important risk factors were approximately uniformly distributed between the two groups. Both are being followed up to 60 months (average follow-up, 30 months). To date, 12 of 60 surgical patients (20%) and 19 of 53 medical patients (36%) died (P less than 0.06). The operative (30-day) mortality declined from a rate of 25% for the first 2 years of the study to 7% for the last 3 years. Of patients randomized in the latter 3 years of the study, 12 of 41 medical patients (29%) and three of 42 surgical patients (7%) died (P less than 0.01). The average follow-up period in this group was 24 months. The proportion surviving 24 months was clearly larger in the surgically treated group (P less than 0.02). The difference in the proportion of patients surviving after surgery as compared with medical treatment was greatest in patients with additional significant disease involving the right coronary artery, with or without left ventricular dysfunction. Relief of angina as assessed by an "anginal score" was also better in surgical patients to a significant degree. Graft-patency rates correlated well with relief of angina, but objective studies including treadmill testing are not yet available.
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The incidence of endocarditis following open-heart operations is declining, but the relative incidence of endocarditis by the opportunistic organisms, both bacterial and fungal, has increased. These "opportunists" require careful identification and sensitivity testing so that appropriate therapy can be planned. In cases of candida endocarditis, a positive precipitin test and elevated candida antibody titer may provide an earlier means of diagnosis than blood cultures. These patients should be treated promptly with adequate dosages of specific antimicrobial or antifungal agents. Reoperation should be considered early if there is evidence of valve dehiscence or embolic phenomena or if drug therapy fails to control the infection.
Nonpenetrating trauma to the abdominal aorta is uncommon and the development of a traumatic abdominal aortic aneurysm is even more rare. The victims of blunt trauma to the abdomen should be examined for diminution or absence of femoral pulses, especially if numbness, diminished sensations, or motor weakness appear following trauma. If pulse abnormalities are present, aortography should be performed promptly to exclude aortic disruption or dissection. Immediate surgery should be performed once the diagnosis of aortic disruption is made. To our knowledge, this is the second reported case of successful surgical treatment of a false aneurysm of the abdominal aorta following nonpenetrating trauma.
The reliability of interpretation of coronary arteriography as a diagnostic tool was investigated in a sub-study of the VA Cooperative Study of Surgical Treatment for Coronary Arterial Occlusive Disease. Twenty-two physicians with varying levels of experience read 13 cine angiograms -- blind -- on two different occasions. Analysis of inter- and intraobserver variability showed that angiographic items about which observers were most inconsistent from one reading to the other had the largest interobserver disagreement as well. They were the distal portions of the left anterior descending and left circumflex arteries. Among the items on which there was most consistent agreement -- namely, the right main coronary artery and presence of ventricular aneurysm -- there was most often agreement between observers as well. When individual readers were evaluated, some observers were far more consistent in their own readings of all the angiographic items than others. This intraobserver agreement in turn correlated fairly well with how often they agreed with the other observers and with how much experience they reported having in reading coronary cineangiograms.
Stenosis of the innominate artery usually occurs in older patients in whom the risks of conventional, corrective procedures such as transthoracic endarterectomy or aorto-innominate arterial bypass grafting are quite high. An axillo-axillary bypass procedure was performed in a high-risk patient with innominate arterial stenosis who had repeated episodes of transient cerebral ischemia due to decreased blood flow through the right carotid artery and reversal of blood flow through the right vertebral artery. Postoperatively, he has had dramatic improvement in his symptoms. Because of its simplicity, avoidance of major thoracotomy, avoidance of temporary occlusion of the carotid artery, and excellent late results, axillo-axillary bypass grafting is being proposed as the procedure of choice for stenosis of the innominate artery.
In 14 patients an oblique view of the aotoiliac region was obtained in addition to the conventional anteroposterior view. Angiograms in oblique projections are indicated in the following situations: (1) where the symptoms cannot be explained by the findings on the conventional anteroposterior view (2) where the patient has had previous anoroiliac grafts and has redeveloped ischmic symptoms, and (3) where patients with unilateral limb ischemia due to unilateral aotoiliac occlusive disease are being considered for a femororfemoral bypass graft procedure. In six patients appreciation of the true significance of the suspected occlusive lesion was of great value in planning the proper surgical procedure. In the remaining eight, angiographic corroboraion of the absence of significant occlusive disease was equally helpful in managing the patient's condition. Examples of each group are presented.
Femorofemoral bypass grafts were performed in 10 patients who developed thrombosis of one of the limbs of previously placed aortoiliac or aortofemoral bifurcation grafts. There were no operative deaths or significant postoperative morbidity, and no amputations had to be performed following the bypass. Nine of the 10 patients have patent grafts from 5 to 70 months (average 33 months) following operation. Of these nine, eight are asymptomatic and one has mild claudication on the side of the unoccluded limb. Because of its simplicity, low operative risk, and encouraging late success rate, we feel that femorofemoral bypass grafting for late unilateral occlusion of a prosthetic bifurcation graft is the procedure of choice.