Biomedical subjects
Publications and source records attributed to G K Sethi.
We present a technique for rapid and easy endomyocardial biopsy of the heterotopic transplanted heart. With a recent resurgence in heterotopic heart transplantation, we believe that ours is a sound technique in obtaining both routine surveillance biopsies as well as evaluating "right-sided pressures" in the "piggy-back" heart.
Vancomycin prophylaxis for coronary artery bypass graft surgery without prosthetic valve implantation voluntarily decreased from 94% to 18% in one medical center. Median hospital stay (10 vs 9 days, P = .30) and number of postoperative infections (17.0% vs 14.3%, P = .60) did not differ among patients who received vancomycin and those who did not.
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OBJECTIVE: The purpose of the study was to investigate the incidence, predictors, morbidity, and mortality associated with postoperative atrial fibrillation (AF) and its impact on intensive care unit (ICU) and postoperative hospital stay in patients undergoing cardiac surgery in the Department of Veterans Affairs (VA). SUMMARY BACKGROUND DATA: Postoperative AF after open cardiac surgery is rather common. The etiology of this arrhythmia and factors responsible for its genesis are unclear, and its impact on postoperative surgical outcomes remains controversial. The purpose of this special substudy was to elucidate the incidence of postoperative AF and the factors associated with its development, as well as the impact of AF on surgical outcome. METHODS: The study population consisted of 3855 patients who underwent open cardiac surgery between September 1993 and December 1996 at 14 VA Medical Centers. Three hundred twenty-nine additional patients were excluded because of lack of complete data or presence of AF before surgery, and 3794 (98.4%) were male with a mean age of 63.7+/-9.6 years. Operations included coronary artery bypass grafting (CABG) (3126, 81%), CABG + AVR (aortic valve replacement) (228, 5.9%), CABG + MVR (mitral valve replacement) (35, 0.9%), AVR (231, 6%), MVR (41, 1.06%), CABG + others (95, 2.46%), and others (99, 2.5%). The incidence of postoperative AF was 29.6%. Multivariate logistic regression analysis of factors found significant on univariate analysis showed the following predictors of postoperative AF: preoperative patient risk predictors: advancing age (odds ratio [OR] 1.61, 95% confidence interval [CI] 1.48-1.75, p < 0.001), chronic obstructive pulmonary disease (OR 1.37, 95% CI 1.12-1.66, p < 0.001), use of digoxin within 2 weeks before surgery (OR 1.37, 95% CI 1.10-1.70, p < 0.003), low resting pulse rate <80 (OR 1.26, 95% CI 1.06-1.51, p < 0.009), high resting systolic blood pressure >120 (OR 1.19, 95% CI 1.02-1.40, p < 0.026), intraoperative process of care predictors: cardiac venting via right superior pulmonary vein (OR 1.42, 95% CI 1.21-1.67, p < 0.0001), mitral valve repair (OR 2.86, 95% CI 1.72-4.73, p < 0.0001) and replacement (OR 2.33, 95% CI 1.55-3.55, p < 0.0001), no use of topical ice slush (OR 1.29, 95% CI 1.10-1.49, p < 0.0009), and use of inotropic agents for greater than 30 minutes after termination of cardiopulmonary bypass (OR 1.36, 95% CI 1.16-1.59, p < 0.0001). Postoperative median ICU stay (3.6 days AF vs. 2 days no AF, p < 0.001) and hospital stay (10 days AF vs. 7 days no AF, p < 0.001) were higher in AF. Morbid events, hospital mortality, and 6-month mortality were significantly higher in AF (p < 0.001): ICU readmission 13% AF vs. 3.9% no AF, perioperative myocardial infarction 7.41 % AF vs. 3.36% no AF, persistent congestive heart failure 4.57% AF vs. 1.4% no AF, reintubation 10.59% AF vs. 2.47% no AF, stroke 5.26% AF vs. 2.44% no AF, hospital mortality 5.95% AF vs. 2.95% no AF, 6-month mortality 9.36% AF vs. 4.17% no AF. CONCLUSIONS: Atrial fibrillation after cardiac surgery occurs in approximately one third of patients and is associated with an increase in adverse events in all measurable outcomes of care and increases the use of hospital resources and, therefore, the cost of care. Strategies to reduce the incidence of AF after cardiac surgery should favorably affect surgical outcomes and reduce utilization of resources and thus lower cost of care.
As the number of potential heart donors remains constant and the number of potential recipients continuous to increase, the need for circulatory devices to bridge patients becomes more important. The CardioWest total artificial heart (TAH) is a pneumatic, implantable system that totally replaces the failing ventricles. It has been utilized worldwide as a bridge to heart transplantation in 79 patients. There were 73 males and six females who received the TAH. Currently three patients remain on the device waiting for transplantation. A total of 55 patients (70%) were transplanted of which 50 survived (91% of patients transplanted) and were discharged home. Idiopathic/dilated cardiomyopathy was the most common etiology followed by ischemic cardiomyopathy. The mean duration of implant was 34 days (range 0-186 days) and the mean age of the group was 45 years (range 16-62 years). Twenty-one patients died while on the device. Multiple organ failure was the major cause of death. There were a total of 255 complications in this group that included reoperation, bleeding, hepatic failure, renal failure, respiratory failure, neurologic events, thromboembolic events, infections, device malfunction, and fit complications. This represented a mean complication rate of three events per patient. The survival rate for the CardioWest TAH of 91% of the patients who reached transplantation is an improvement over that of the Symbion registry (55% of those transplanted) probably as a result of a better patient selection and better control of the coagulation system. These results are also comparable to those survival results obtained with other biventricular and left ventricular assist devices currently available.
Reconstruction was accomplished in a 2 heart-lung recipients with situs inversus resulting in a left-sided systemic venous atrium. We created a large common atrium that was closed on the left side, leaving an atrial cuff on the inferior right quadrant. To this we anastomosed the donor right atrium, which had been opened laterally between the cavae. This resulted in some clockwise rotation of the ventricles and anterior positioning of the apex. The right pulmonary veins passed superior to the atrial anastomosis and posterior to the donor right atrium. Cardiopulmonary function was excellent in both cases.
BACKGROUND: Advances in myocardial preservation techniques and immunosuppressive drug therapy have resulted in heart transplantation as an acceptable treatment for end-stage heart failure. However, excessive periods of global myocardial ischemia followed by reperfusion can progress to irreversible graft injury. It has been reported that cyclosporine A (in addition to its well-characterized immunosuppressive actions) can blunt certain features of ischemia and reperfusion injury. This study was performed to examine the ability of cyclosporine A to attenuate such injury in a model of heart transplantation. METHODS: Twenty rabbit heterotopic transplants were divided into four study groups: (1) 30-minute ischemic control hearts; (2) 30-minute ischemic cyclosporine A-treated hearts; (3) 4-hour ischemic control hearts; and (4) 4-hour ischemic cyclosporine A-treated hearts. A single dose of cyclosporine A (10 mg/kg intravenously) or vehicle was administered to both the donor and recipient rabbits 45 minutes before heart explantation and heart transplantation, respectively. RESULTS: After transplantation and 30 minutes of reperfusion, the 4-hour ischemic control hearts showed a significant (p < 0.01) leftward shift in the left ventricular end-diastolic pressure versus left ventricular volume curve compared with the 30-minute ischemic control hearts. This finding represents higher end-diastolic pressures and incomplete diastolic relaxation caused by ischemia and reperfusion. Cyclosporine A administration to the donor and recipient rabbits resulted in a significant improvement (p < 0.01) in diastolic relaxation (shift in the left ventricular end-diastolic pressure versus left ventricular volume curve back to the right) compared with 4-hour ischemic control hearts. Cyclosporine A-treated hearts also showed significant improvements in the rate of diastolic pressure fall (p < 0.05) and tau (the isovolumetric pressure decay constant) (p < 0.01) compared with ischemic control hearts. CONCLUSIONS: These results indicate that single doses of cyclosporine A to both the donor and recipient inhibit the dysfunction in extent and rate of left ventricular relaxation caused by prolonged global ischemia and reperfusion. Possible mechanisms for cyclosporine A's myocardial protective actions are presented in the discussion.
Well-known complications of heart-lung transplantation include mediastinal bleeding and phrenic nerve injury. Conventional technique places the hila behind the phrenic nerves. We have placed the hila in front of the phrenic nerve in our last 10 patients, using direct caval anastomoses when feasible. This minimizes traction on and dissection around the phrenic nerves, and allows anterior rotation of the heart-lung block for easier hemostasis of the posterior mediastinum after implantation.
This first article of the supplement describes the rationale for the Department of Veterans Affairs Cooperative Study, Processes, Structures, and Outcomes in Cardiac Surgery, which was designed to demonstrate statistically and clinically meaningful linkages between processes and structures of care and the outcomes of that care. United States health care is in an era of great enthusiasm for the use of health care outcomes to assess and improve quality of care. An important reason for this enthusiasm is the concern that processes and structures of care, which traditionally have been selected arbitrarily without valid linkages to favorable outcomes, may not result in the desired outcomes of care. Furthermore, health care outcomes are intrinsic to the definition of quality of care and should be relatively free of preconceived biases about how care should be provided. However, the limitations to outcomes-directed quality improvement have been inadequately recognized. These limitations include the following: (1) mortality, the most commonly used outcome, is usually sufficiently rare, resulting in inadequate statistical power; (2) nonfatal outcomes are much more difficult to measure reliably; (3) outcomes may not be measurable for an extended period of time after the care episode, making linkage to quality improvement inefficient; and (4) patients often desire good processes of care as well as favorable outcomes. A review of the literature found relatively few reports linking processes and structures of care to favorable outcomes. Significant relationships between processes of care and outcomes have been reported for several medical conditions (congestive heart failure, acute myocardial infarction, pneumonia, and stroke) when the patient has been considered the unit of analysis. However, there is a paucity of published meaningful process-outcome or structure-outcome linkages for surgical conditions or for any conditions when the hospital has been the focus of analysis. The authors concluded that quality improvement will proceed most efficiently and effectively if all three elements of Donabedian's quality triad (processes, structures, and outcomes) are used and if the processes and structures chosen have been demonstrated to be associated with desired outcomes of care.
Recently, a growing interest has arisen in defining and measuring health care outcomes. Although outcome measures may be used as potential quality-of-care screens, outcomes cannot indicate directly how care might be improved. Thus, the Processes, Structures, and Outcomes of Care in Cardiac Surgery (PSOCS) study was designed to investigate the linkages between the processes and structures of care with risk-adjusted outcomes for cardiac surgery care. Data are being collected on a comprehensive array of risk factors, processes, structures, and outcomes of care at 14 Veterans Affairs Medical Centers for this prospective, observational study. Approximately 6,000 cardiac surgery patients will be enrolled in this study over a 4.5-year period. Patient selection is based on a 6 workday rotating sampling frame with an oversampling of emergent patients. During the study, a register of all patients undergoing cardiac surgery at these centers is being maintained to assess the overall context of patient recruitment. The study will continue to enroll patients through December 1996. Major study end points extend beyond traditional measures of 30-day mortality and morbidity to encompass more innovative intermediate outcome measures, including changes in physical functional status and health-related quality of life.
The processes, Structures, and Outcomes of Care in Cardiac Surgery (PSOCS) study involves data collection on a comprehensive array of patient risk factors, processes, structures, and short-term outcomes of care at 14 participating Veterans Administration medical centers. This article summarizes the PSOCS conceptual models that serve as the theoretical framework for analyzing the hypothesized risk-process-structure-outcome relationships being investigated. The PSOCS data set includes more than 1,100 variables related to each patient and more than 300 variables related to provider-specific and facility-specific characteristics. This massive data set presents a formidable analytic challenge. The conceptual modeling process involved four-steps: 1) establishing a vision of the general conceptual model defining the overall risk-process-structure-outcome relationships, 2) developing specific hypotheses or subhypotheses, 3) visualizing a hierarchical set of dimensions and subdimensions, and 4) uniquely assigning each variable collected in the study to a dimension or subdimension for purposes of testing the study's primary hypotheses. A multidisciplinary team participated in this modeling process. The goal of the conceptual modeling process is to identify clearly the actions (ie, the changes in either processes or structures that are linked to risk-adjusted patient outcomes) that can be taken by clinicians, management, and policymakers to improve the quality of cardiac surgical care.
It is hypothesized that variations in the processes and structures of the selection of patients and the conduct of the surgical procedure may influence risk-adjusted outcome in patients undergoing cardiac surgery. For this reason, the results of the pilot phase of this Veterans Affairs cooperative study were reviewed to determine the variation in the operative practices at six pilot institutions. There were large variations in the percentage of elective, urgent, and emergent cases at each institution, ranging from 58% to 96% elective, 3% to 31% urgent, and 1% to 8% emergent. There was also a tenfold increase in the preoperative use of intra-aortic balloon pump for control of unstable angina, varying from 0.8% to 10.6%. Five of the six centers had accredited thoracic surgical residency programs. There was large variation in the preoperative participation of attending surgeons, from 100% participation at three centers to less than 5% in one. The operation was performed by the attending surgeon in 28% of cases, but this varied from 0% to 100%, depending on the hospital. Cold cardioplegia was used almost uniformly (99%) for myocardial protection; the use of retrograde cardioplegia varied from 2% to 89% among hospitals, and the use of blood cardioplegia ranged from 0% to 100%, with an average of 54% of cases. The use of myocardial temperature monitoring varied between hospitals, from 25% to 99%. The use of the cell saving devices to scavenge shed blood varied from 5% to 99%, and the frequency of the use of banked blood varied from 25% to 65%, depending on the institution. The internal mammary artery was used for 67% patients undergoing coronary artery bypass graft, with a variation between hospitals of 39% to 83%. One hospital used a single cross-clamping technique for the performance of proximal anastomoses in 95% of cases, as opposed to all other hospitals, who used this technique in less than 10% of cases. Aortic venting varied from 58% to 98% and left ventricular venting from 1% to 38%. The use of porcine valves varied approximately 15% in three hospitals to 30% to 40% in the other three hospitals. There were tremendous variations in the duration of operative procedure (5.2-7.3 hours), actual operating time (4.0-5.6 hours), total cardiopulmonary bypass duration (102-146 minutes), and ischemic time (50-87 minutes). The use of inotropic support varied from 41% to 91% between hospitals.(ABSTRACT TRUNCATED AT 400 WORDS)
Nurses play an invaluable role as key members of the cardiac surgery patient's medical care team. Over the last century, the nursing profession has become more independent and autonomous. Despite the widespread use of nursing quality indicators, the effect of nursing-specific processes and structures of care on patient outcomes is unknown. Thus, the Processes, Structures, and Outcomes of Care in Cardiac Surgery (PSOCS) study was initiated, in part, to determine the potential effect of nursing processes and structures of care on cardiac surgery patients' risk-adjusted outcomes. In this article, the authors summarize the key components of nursing structures of care incorporated in the PSOCS study. Nursing process variables were not sufficiently designed into the study to address hypotheses relating nursing care processes to patient outcomes. An analysis of the pilot test data from September 1992 to September 1993 demonstrated potentially important variations between the six pilot centers regarding nursing care provider profiles (eg, educational preparation, specialty certification, and experience levels) and nursing staff ratios (eg, within the surgical intensive care unit). When linked to risk-adjusted patient outcomes, these variations in nursing structure of care may offer important insights toward improving the quality of care of cardiac surgery patients.
Anesthesia care is an integral component of cardiac surgery. Emphasis on cost-effectiveness and decreased hospital stay has prompted reevaluation of anesthesia practice. However, the role of anesthesia process and structure variables in relation to patient outcomes is largely unknown. Processes, Structures and Outcomes of Care in Cardiac Surgery is the first epidemiologic study to collect data on anesthesia processes, such as the pharmacologic components of anesthesia and types of cardiovascular monitors used. Structures of care, such as resident staffing, supervision, completeness of documentation, and training and experience of care providers, are also being assessed. Pilot data collected from September 1992 to September 1993 demonstrate substantial variation between the six study sites in selected processes and structures. Despite the near-universal use of narcotic anesthesia as the primary anesthetic technique, variation in the type of opioid and adjuvant benzodiazepine used was observed. Regarding invasive hemodynamic monitoring, most centers used only one type of catheter. Intraoperative transesophageal echocardiography was used commonly at several centers for valve surgery, whereas other centers did not use it at all. Its use during coronary artery bypass grafting was less common. Assessment of the preoperative anesthesia note revealed that coronary anatomy and ventricular function were noted in nearly all instances. However, a clear notation that risks and benefits of anesthesia were discussed was less frequent. Structures related to anesthesia attending staffing, board certification, and experience revealed variation. Some sites had smaller and/or more experienced attending staffs, whereas others had larger and/or less experienced staffs. These pilot findings appear to validate the authors' hypotheses that variations in anesthesia practice are present within the Veterans Affairs system. They suggest that the variable set is robust enough to relate processes and structures of anesthesia care to patient outcome.
Patient self-report measures are increasingly valued as outcome variables in health services research studies. In this article, the authors describe the Functional Status, Health Related Quality of Life, Life Satisfaction, and Patient Satisfaction scales included in the Processes, Structures, and Outcomes of Cardiac Surgery (PSOCS) cooperative study underway within the Department of Veterans Affairs health care system. In addition to reporting on the baseline psychometric characteristics of these instruments, the authors compared preoperative Medical Outcomes Study SF-36 data from the study patients with survey data from a probability sample of the US population and with preoperative data on cardiac surgery patients from a high volume private sector surgical practice. Descriptive analyses indicate that the SF-36 profiles for all of the cardiac patients are highly similar. The Veterans Affairs and private sector patients report diminished physical functioning, physical role functioning, and emotional role functioning as well as reduced energy relative to an age-matched comparison sample. At the same time, however, the Veterans Affairs patients evidenced lower levels of capacity on most of the SF-36 dimensions relative to the private sector patients.
The authors made some preliminary judgments regarding the reliability and representativeness of the data in the early stages of the Veterans Affairs Cooperative Study entitled Processes, Structures, and Outcomes of Care in Cardiac Surgery (PSOCS). Preliminary PSOCS interobserver reliability and potential patient and site selection bias reported were based on comparisons with identical risk, procedure, and outcome data items collected independently in the Continuous Improvement in Cardiac Surgery Study. PSOCS interobserver reliability for this limited set of variables was good to excellent. At the six pilot centers, there were few important differences between patients entered into PSOCS and those not entered. The 14 Veterans Affairs medical centers that will participate in the full-scale PSOCS study and the 29 nonparticipating centers exhibited similar patient populations. will be valuable.
Accurate collection and successful management of data are problems common to all scientific studies. For studies in which large quantities of data are collected by means of questionnaires and/or forms, data base management becomes quite laborious and time consuming. Data base management comprises data collection, data entry, data editing, and data base maintenance. In this article, the authors describe the development of an interactive data base management (IDM) system for the collection of more than 1,400 variables from a targeted population of 6,000 patients undergoing heart surgery requiring cardiopulmonary bypass. The goals of the IDM system are to increase the accuracy and efficiency with which this large amount of data is collected and processed, to reduce research nurse work load through automation of certain administrative and clerical activities, and to improve the process for implementing a uniform study protocol, standardized forms, and definitions across sites.
A multicenter prospective trial of the CarboMedics valve was initiated in July 1988. Twelve North American centers were included for the purpose of establishing the safety and efficacy of this new rotatable, bileaflet, pyrolytic-Carbon prosthesis. The study included 786 patients (using 891 valves) enrolled between July 1988 and August 1992. There were 447 male and 339 female patients from ages 2 to 83 years. Of the 618 primary replacement operations (including double valves), 393 were aortic and 292 were mitral valve replacements. Mean follow-up time was 16.1 months; 94.7% of patients had completed documentation up to and including one year. New York Heart Association functional class was III or IV for 84.4% of patients preoperatively, and I and II in over 96% of patients for the first three postoperative years. Survival for the entire group was 93% (622) at 1 month, 89% (504) at 1 year, 87% (213) at 2 years, and 85% (41) at 3 years. There were no significant survival differences between primary and repeat replacements or between aortic, mitral, and double-valve replacements. Primary replacement patients with concomitant procedures (n = 241) had slightly decreased survival rates compared with those who underwent isolated procedures (isolated survival rate, 92% [98]; concomitant procedure survival rate, 81% [59] at 2 years; p = 0.002). There was no valve failure. Linearized rates (events per 100 patient-years) in primary replacement patients after 30 days included the following: thrombosis, 0.39; thromboembolism, 0.92; hemolysis, 0.53; anticoagulant-related hemorrhage, 2.36; paravalvular leak, 0.92; endocarditis, 0.53; reoperation, 0.92; and explantation, 0.66.(ABSTRACT TRUNCATED AT 250 WORDS)