Walter G. Wolfe

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.

Comparison of medical and surgical therapy for uncomplicated descending aortic dissection

BACKGROUND Variability in the international normalized ratio (INR) of prothrombin time has been suggested to be related to outcome in patients with atrial fibrillation (AF) under warfarin therapy, but its determinants remain unclear.Methods and Results:The study population consisted of 626 AF patients under warfarin therapy in the Shinken Database (n=22,230). INR variability was calculated by Fihns method. Determinants of high log INR variability (defined as over mean+standard deviation) were determined by logistic regression analyses. Symptomatic heart failure (odds ratio [OR] 3.974, 95% confidence interval [CI] 2.510-6.292), older age (≥75 years old; OR 2.984, 95% CI 1.844-4.826) and severe renal dysfunction (eGFR <30 mL/min/1.73 m2; OR 3.918, 95% CI 1.742-8.813) were identified as independent predictors of high INR variability on multivariate logistic regression analysis. CONCLUSIONS The determinants of INR variability in AF patients under warfarin therapy could assist Japanese clinicians in identifying patients likely to show unstable warfarin control irrespective of the definition of the target INR range.

Lung tumor growth correlates with glucose metabolism measured by fluoride-18 fluorodeoxyglucose positron emission tomography.

BACKGROUND The growth rate, or doubling time, of radiographically indeterminate pulmonary abnormalities is an important determinant of malignancy. Prospective calculation of doubling time, however, delays diagnosis and treatment. Positron emission tomography (PET) using the glucose analogue fluoride-18 fluorodeoxyglucose (FDG) measures the enhanced glucose uptake characteristic of neoplastic cells. We postulated that if FDG activity correlates with doubling time, then PET may allow prompt diagnosis of lung cancer. METHODS From March 1992 to July 1993, all patients with indeterminate focal pulmonary abnormalities were eligible for FDG PET imaging. In 53 patients, serial chest radiographs or computed tomograms were available and doubling time was computed. The FDG activity within the lesion was expressed as a standardized uptake ratio. RESULTS The mean standardized uptake ratio (+/- SD) was 5.9 +/- 2.7 in 34 patients with cancer, versus 2.0 +/- 1.7 in 19 with benign disease (p < 0.001). Using a criterion of standardized uptake ratio 2.5 or greater for malignancy, the accuracy of PET was 92% (49 of 53). The standardized uptake ratio was significantly correlated with doubling time (r = -0.89; p = 0.002). CONCLUSION These data suggest a direct relation between tumor growth and FDG uptake in lung cancer. The technique of FDG PET demonstrates exceptional accuracy and may permit prompt diagnosis of lung cancer.

Aneurysm of aberrant subclavian artery with a review of the literature.

Aneurysms arising in an aberrant subclavian artery are rare but constitute a potentially lethal condition that can be treated successfully when appropriately identified. Virtually all patients have a superior mediastinal mass that may be asymptomatic, but usually patients have symptoms of dysphagia, chest pain, or shortness of breath. An accurate diagnosis can now be made noninvasively with computerized tomography. The presence of an aneurysm of an anomalous subclavian artery is an indication for surgical resection. Resection of the aneurysm may be approached through either a right or left thoracotomy. Reestablishment of continuity of flow to the right subclavian artery decreases the risk of ischemia of the extremities and prevents development of the subclavian steal syndrome. Reestablishment of flow to the right subclavian artery is more easily performed through a right thoracotomy incision but this approach limits control of the aorta at a possibly treacherous connection between aorta and aneurysm. In such circumstances a preliminary extra-anatomic reconstitution of flow to the right subclavian artery followed by a left thoracotomy may be preferable. A 67-year-old woman is described who had resection and grafting of an aneurysm in an aberrant right subclavian artery together with a review of the literature and a discussion of problems in the management of patients with this condition.

Detection of primary and recurrent lung cancer by means of F-18 fluorodeoxyglucose positron emission tomography (FDG PET)*

Positron emission tomography (PET), with the glucose analog F-18 fluoro-deoxyglucose (FDG), takes advantage of the enhanced glucose uptake observed in neoplastic cells. We examined whether the detection of preferential FDG uptake with PET permits differentiation between benign and malignant focal pulmonary lesions in patients with suspected primary or recurrent lung cancer. Between November 1991 and September 1993, 100 patients with indeterminate focal pulmonary abnormalities including 16 patients who had previous lung resections for cancer were prospectively studied. Tissue diagnosis was obtained by transbronchial or percutaneous biopsy (n = 49) and open biopsy or resection (n = 35). Three patients underwent extended observation (> 2 years) alone. Excluded were 13 patients lacking firm pathologic diagnoses and less than 2-year follow-up. FDG activity in the lesion was expressed as a calculated standardized uptake ratio. Mean standardized uptake ratio (+/- standard deviation) was 6.6 (+/- 3.1) in 59 patients with cancer versus 2.0 (+/- 1.6) in 28 with benign disease (p = 0.0001; unpaired t test, two-sided). With a standardized uptake ratio > or = 2.5 used for detecting malignancy, sensitivity, specificity, and accuracy were 97% (57/59), 82% (23/28), and 92% (80/87), respectively. Notably, in patients evaluated for pulmonary abnormalities after lung resection for cancer, all chest recurrences were correctly identified. The exceptional sensitivity of FDG PET demonstrates that malignant pulmonary lesions preferentially accumulate FDG, which results in a standardized uptake ratio > or = 2.5. PET may be useful for distinguishing recurrent tumor from postoperative, or postradiation, changes. If performed in all patients before open biopsy, PET increases the diagnostic yield by reducing the number of patients who have benign lesions at operation. Moreover, by lowering expenditures for hospitalization and other diagnostic procedures, FDG PET may significantly reduce health care costs.

BRONCHIAL CARCINOID TUMORS: A RETROSPECTIVE ANALYSIS OF 126 PATIENTS

From 1970 until 1990, 8,958 cases of primary carcinoma of the lung were diagnosed at the Duke University Medical Center. During the same period, 126 patients (mean age, 53 +/- 13 years) were diagnosed with bronchial carcinoid. The overall survival was 78% for 5 years and 71% for 10 years. Surgical treatment in 106 patients included pneumonectomy (15), lobectomy (63 with 9 bronchoplastic procedures), stapled wedge resection (22), and bronchoscopic laser resection (6). The method of diagnosis was chest roentgenography (121), chest computed tomography (77), mediastinal tomography (31), bronchoscopy (81), bronchoscopic brushing and washing (50), bronchoscopic biopsy (40), transthoracic needle biopsy (27), thoracotomy (100), and autopsy (5). Univariate analysis of the medical history, presenting signs and symptoms, diagnostic test results, and pathologic data predicted improved survival (p less than 0.001) for: female sex (n = 58), asymptomatic presentation (n = 47), normal serum serotonin or urinary hydroxyindoleacetic acid levels (n = 76), peripheral location of the primary tumor (n = 50), pathologic stage I or II (n = 91), negative lymph nodes (n = 80), primary tumor 2 cm or less in diameter (n = 67), and typical histology (n = 80). No significance (p greater than 0.1) was observed for age, smoking history, race, family history of carcinoid, environmental exposure, or hemoptysis. The most important factors affecting survival defined by multivariate analysis were (p less than 0.01) pathologic stage, atypical histology, and asymptomatic presentation. Bronchial carcinoid tumors are unique, making up 1% to 2% of primary lung neoplasms and having an excellent prognosis after resection with a 95% 5-year and 93% 10-year survival for pathologic stage I disease.

Management and long-term outcome of aortic dissection.

All 163 patients admitted to one institution between 1975 and 1988 with aortic dissection were reviewed. Type I and type II patients received grafting of the ascending aorta, with an intraoperative mortality rate of 11%. For type III dissection, management was medical in 53 patients, while 19 required surgery for aortic rupture or expansion, with an intraoperative mortality rate of 11%. The 9- or 10-year survival rates were 29%, 46%, and 29% for types I, II, and III respectively. Of 135 patients with primary aortic dissection, 17 (13%) required subsequent aortic surgery. Cause of late death was other cardiovascular disease in 38%, rupture of another aortic segment in 18%, sudden death in 24%, and other medical conditions in 21%. Although operative therapy for types I and II dissections and reserving operation for selected type III dissections provides acceptable long-term survival, careful follow-up is necessary due to concurrent cardiovascular disease and residual aortic disease.

The utility of transesophageal echocardiography and Doppler color flow imaging in patients undergoing cardiac valve surgery

To assess the value of intraoperative transesophageal echocardiography during cardiac valve surgery, 154 consecutive patients who had a valve operation in conjunction with pre- and postcardiopulmonary bypass transesophageal imaging were studied. Prebypass imaging yielded unsuspected findings that either assisted or changed the planned operation in 29 (19%) of the 154 patients. Imaging immediately after bypass revealed unsatisfactory operative results that necessitated immediate further surgery in 10 (6%) of the 154 patients. Postbypass left ventricular dysfunction, prompting administration of inotropic agents, was identified in 13 patients (8%). Transesophageal echocardiography proved most useful when both two-dimensional and Doppler color flow imaging were employed in patients undergoing a mitral valve operation, where surgical decisions based on echocardiographic results were made in 26 (41%) of 64 cases. Postbypass echocardiographic findings identified patients at risk for an adverse postoperative outcome. Of 123 patients whose postbypass valve function was judged to be satisfactory, 18 (15%) had a major postoperative complication and 6 (5%) died, whereas of 7 patients with moderate residual valve dysfunction, 6 (86%) had a postoperative complication and 3 (43%) died (p less than 0.05 for both). Likewise, of 131 patients with preserved postbypass left ventricular function, 12 (9%) had a major complication and 7 (5%) died, whereas of 23 patients with reduced ventricular function, 17 (73%) had a postoperative complication and 6 (26%) died (p less than 0.05 for both). These data indicate that intraoperative transesophageal echocardiography is useful in formulating the surgical plan, assessing immediate operative results and identifying patients with unsatisfactory results who are at increased risk for postoperative complications.

Evaluation of vacuum-assisted closure in the treatment of poststernotomy mediastinitis.

OBJECTIVE Poststernotomy mediastinitis, although infrequent, is a potentially life-threatening complication of cardiac surgery that continues to have a significant morbidity and mortality despite aggressive therapy. Vacuum-assisted closure uses controlled suction to provide evacuation of wound fluid, decrease bacterial colonization, stimulate granulation tissue, and reduce the need for dressing changes. METHODS One hundred two patients from Duke University Hospital, The Durham Veterans Administration Hospital, and referring institutions underwent vacuum-assisted closure treatment. There were 63 men and 39 women, with a mean age of 67. The infection was noticed between postoperative days 8 and 34, at which time the wounds were opened and debrided. RESULTS Ninety-six of the 102 patients received vacuum-assisted therapy while the remaining 6 underwent daily multiple dressing changes without vacuum-assisted therapy. Fifty-three of the 96 patients required only sternal debridement, followed by wound vacuum therapy and closure by secondary intention, while the remaining 43 had an additional procedure. Of these, 33 patients underwent omental transposition and 10 patients had a pectoralis flap. The length of stay for all patients was 27 +/- 12 days. This was related in part to intravenous antibiotics. Hospital mortality for all patients was 3.7% (4 patients). Two of these patients underwent vascular flap and succumbed to multisystemic organ failure, while the other 2 received only wound vacuum therapy following debridement and succumbed to overwhelming sepsis. CONCLUSION Vacuum-assisted drainage is an effective therapy for mediastinitis following debridement or before placement of a vascularized tissue flap.

Long-term outcome after biologic versus mechanical aortic valve replacement in 841 patients

OBJECTIVE The purpose of this study was to optimize selection criteria of biologic versus mechanical valve prostheses for aortic valve replacement. METHODS Retrospective analysis was performed for 841 patients undergoing isolated, first-time aortic valve replacement with Carpentier-Edwards (n = 429) or St Jude Medical (n = 412) prostheses. RESULTS Patients with Carpentier-Edwards and St Jude Medical valves had similar characteristics. Ten-year survival was similar in each group (Carpentier-Edwards 54% 3% versus St Jude Medical 50% 6%; P =.4). Independent predictors of worse survival were older age, renal or lung disease, ejection fraction less than 40%, diabetes, and coronary disease. Carpentier-Edwards versus St Jude Medical prostheses did not affect survival (P =.4). Independent predictors of aortic valve reoperation were younger age and Carpentier-Edwards prosthesis. The linearized rates of thromboembolism were similar, but the linearized rate of hemorrhage was lower with Carpentier-Edwards prostheses (P <.01). Perivalvular leak within 6 months of operation was more likely with St Jude Medical than with Carpentier-Edwards prostheses (P =.02). Estimated 10-year survival free from valve-related morbidity was better for the St Jude Medical valve in patients aged less than 65 years and was better for the Carpentier-Edwards valve in patients aged more than 65 years. Patients with renal disease, lung disease (in patients more than age 60 years), ejection fraction less than 40%, or coronary disease had a life expectancy of less than 10 years. CONCLUSIONS For first-time, isolated aortic valve replacement, mechanical prostheses should be considered in patients under age 65 years with a life expectancy of at least 10 years. Bioprostheses should be considered in patients over age 65 years or with lung disease (in patients over age 60 years), renal disease, coronary disease, ejection fraction less than 40%, or a life expectancy less than 10 years.