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G K Sethi

Publications and source records attributed to G K Sethi.

At least 37 records · Page 2Linked to original sources
PubMed1995

The Processes, Structures, and Outcomes of Care in Cardiac Surgery study protocol.

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.

Aged↗
PubMed1995

Relationships between patient-related risk factors, processes, structures, and outcomes of cardiac surgical care. Conceptual models.

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.

Cardiac Surgical Procedures↗
PubMed1995

Variations in processes and structures of cardiac surgery practice.

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)

Aged↗
PubMed1995

Variations in the processes and structures of cardiac surgery nursing care.

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.

Adult↗
PubMed1995

Evaluating anesthesia health care delivery for cardiac surgery. The role of process and structure variables.

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.

Anesthesiology↗
PubMed1995

Self-report measures for assessing treatment outcomes in cardiac surgery patients.

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.

Cardiac Surgical Procedures↗
PubMed1995

An analysis of interobserver reliability and representativeness of data from the Veterans Affairs Cooperative Study on Processes, Structures, and Outcomes in Cardiac Surgery.

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.

Cardiac Surgical Procedures↗
PubMed1995

Development of an interactive data base management system for capturing large volumes of data.

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.

Cardiac Surgical Procedures↗
PubMed1994

Four-year experience with the CarboMedics valve: the North American experience. North American team of clinical investigators for the CarboMedics prosthetic heart valve.

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)

Actuarial Analysis↗
PubMed1994

The effects of improved hemodynamics on aortic dimensions in patients undergoing heart transplantation.

PURPOSE: Retrospective studies have demonstrated an accelerated growth rate of abdominal aortic aneurysms in heart transplant patients. This prospective study was undertaken to define the relationship between cardiac hemodynamics and posttransplant aortic dilation. METHODS: Sixty-eight patients undergoing heart (n = 60) or heart-lung (n = 8) transplantation were prospectively evaluated with abdominal ultrasonography before transplantation and annually after transplantation. Risk factors implicated in aneurysm growth, including age, indication for transplantation, immunosuppression, posttransplantation hypertension, and abdominal aortic dimension before transplantation were recorded. All patients underwent annual coronary artery catheterization and multiple gated acquisition scanning. RESULTS: Thirty-seven patients (54%) had no change in aortic diameter after transplantation (pretransplantation and posttransplantation diameter = 1.8 +/- 0.3 cm), over a mean follow-up period of 28 +/- 14 months. In the remaining 31 (46%) patients, aortic diameter increased by 0.5 +/- 0.6 cm over 31 +/- 15 months (p < 0.05). Four (6%) of these 31 patients had abdominal aortic aneurysms (mean aortic diameter = 5.0 +/- 0.8 cm). The mean increase in aortic diameter among these 4 patients was 1.8 +/- 0.2 cm (annual rate of growth = 0.96 +/- 0.3 cm/year). Patients experiencing an increase in aortic dimension after transplantation had significantly lower (p < 0.005) pretransplantation ejection fractions (17.1% +/- 10.5% vs 28.6% +/- 18.1%) and, as a consequence, significantly greater (p < 0.05) increases in their ejection fractions after transplantation compared with patients with stable aortic dimensions (42.7% +/- 12.6% vs 31.8% +/- 18.0%). CONCLUSIONS: Of 68 heart transplant patients prospectively evaluated, aortic diameter increased in 31 (46%); new aneurysms developed in four of these patients. Greater incremental increases in cardiac ejection fraction were significant correlates with aortic enlargement.

Adult↗
PubMed1994

Comparison of the causes of late death following aortic and mitral valve replacement. VA Co-operative Study on Valvular Heart Disease.

This report examines and compares the causes of late non-surgical death in 146 of 690 (21%) patients undergoing isolated aortic valve replacement (AVR) and in 79 of 273 (29%) patients undergoing mitral valve replacement (MVR) over a five year follow up period. The distribution of valve related, cardiac but not valve-related and non-cardiac deaths was 43%, 23% and 34% respectively for AVR and 65%, 29% and 6% respectively for MVR; the difference between these distributions was statistically significant. The specific causes of valve related deaths included bleeding (11% vs. 5% for MVR vs. AVR), systemic embolization (6% vs. 4% for MVR vs. AVR), endocarditis (14% vs. 8% for MVR vs. AVR), valve regurgitation (8% vs. 5% for MVR vs. AVR) and valve obstruction (3% vs. 5% for MVR vs. AVR). Sudden death (less than one hour from the onset of acute symptoms) accounted for 23% of deaths for MVR and 16% for AVR. The deaths due to congestive heart failure with normal prosthetic valve function were 13% and 8% for MVR and AVR respectively. Non-cardiac causes accounted for only 6% of MVR deaths but 34% of AVR deaths (p < 0.001). There was no significant difference in the late mortality between mechanical and bioprosthetic valves in the aortic position (24% vs. 22%), but the cumulative rate of late deaths was higher in patients with the Björk-Shiley than with the Hancock valve in the mitral position (41% vs. 25%, p < 0.02). In conclusion, about one quarter of patients surviving either aortic or mitral valve replacement died within five years.(ABSTRACT TRUNCATED AT 250 WORDS)

Aged↗
PubMed1993

A comparison of outcomes in men 11 years after heart-valve replacement with a mechanical valve or bioprosthesis. Veterans Affairs Cooperative Study on Valvular Heart Disease.

BACKGROUND: Mechanical heart valves are durable but thrombogenic, and their use requires that the patient receive anticoagulants. In contrast, bioprosthetic valves are less thrombogenic, but they have limited durability because of tissue deterioration. METHODS: To compare the outcomes of patients who receive these two types of valves, we randomly assigned 575 men scheduled to undergo aortic-valve or mitral-valve replacement to receive either a mechanical or a bioprosthetic valve. The primary end points were death from any cause and any valve-related complication. RESULTS: During an average follow-up of 11 years, there was no difference between the two groups in the probability of death from any cause (11-year probability for mechanical valves, 0.57; for bioprostheses, 0.62; P = 0.57) or in the probability of any valve-related complication (0.65 and 0.69, respectively; P = 0.39). There was a much higher rate of structural valve failure among patients who received bioprosthetic valves (11-year probability, 0.15 for the aortic valves and 0.36 for the mitral valves) than among those who received mechanical valves (no valve failures; P < 0.001). However, this difference was offset by a higher rate of bleeding complications among patients with mechanical valves than among those with bioprosthetic valves (11-year probability, 0.42 and 0.26, respectively; P < 0.001) and by a greater frequency of peri-prosthetic valvular regurgitation among patients with mechanical mitral valves than among those with mitral bioprostheses (11-year probability, 0.17 and 0.09, respectively; P = 0.05). CONCLUSIONS: After 11 years, the rates of survival and freedom from all valve-related complications were similar for patients who received mechanical heart valves and those who received bioprosthetic heart valves. However, structural failure was observed only with the bioprosthetic valves, whereas bleeding complications were more frequent among patients who received mechanical valves.

Aortic Valve↗
PubMed1993

Incidence and recurrence of gastrointestinal cytomegalovirus infection in heart transplantation.

Cytomegalovirus (CMV) infection of the upper gastrointestinal tract is a major cause of morbidity in heart transplant recipients. Since April 1985, 201 patients underwent heart transplantation at our institution. Immunosuppressive therapy was with a triple drug regimen of cyclosporin A, prednisone, and azathioprine. Fifty-three of these patients had upper gastrointestinal symptoms, which primarily consisted of abdominal pain or nausea and vomiting despite prophylactic treatment with antacids, H2 blockers, or both. A total of 79 esophagogastroduodenoscopies were performed in this group; 15 patients required more than one esophagogastroduodenoscopy for recurrent symptoms. Of these 53 patients with persistent gastrointestinal symptoms, 16 (30.2%) had diffuse erythema or ulceration of the gastric mucosa (14), esophagus (1), and duodenum (1) with biopsy results that were positive for CMV on viral cultures (incidence, 8%). All patients with positive biopsy results were treated with intravenous ganciclovir at a dose of 10 mg.kg-1.day-1 in two divided doses for a period of 2 weeks. Recurrence developed in 6 patients (37.5%) and necessitated repeated therapy with ganciclovir. None of the 16 patients died as a result of gastrointestinal CMV infection. Patients who were seronegative for CMV and received a seropositive heart experienced earlier clinical manifestation of CMV infection. Infection of the upper gastrointestinal tract with CMV is a major cause of morbidity in cardiac transplant patients that may progress to a life-threatening complication if left untreated. Early diagnosis with esophagogastroduodenoscopy and biopsy for viral cultures is essential for documentation and proper management.

Adult↗
PubMed1993

Use of the Symbion biventricular assist device in bridging to transplantation.

From 1988 to 1991 13 patients received Symbion biventricular assist devices in attempts to bridge them to cardiac transplantation. All 7 of those who had cardiac transplants survived to hospital discharge. One death occurred 60 days after transplantation because of rejection. All other patients who received transplants are surviving. Implant times in this group varied from 10 to 164 days (mean, 55 days). There were two embolic neurologic events and two significant infections, and 2 of the survivors were dialyzed for reversible renal failure before transplantation. Of those who died on device support, 3 presented on centrifugal pump support. The three other deaths were caused by graft rejection, multiple organ failure, and multiple peripheral emboli. Biventricular assist devices optimally provide cardiac outputs of 4 to 5 L/min, can be quickly inserted often without requiring cardiopulmonary bypass, are easily explanted, and seem best suited for patients weighing less than 80 kg.

Adult↗
PubMed1993

Obstructive sleep apnea in heart transplant patients. A report of five cases.

Clinically significant obstructive sleep apnea syndrome (OSAS) was diagnosed in five patients who had undergone heart transplantation and they represent 2.5 percent of our transplantation series. To determine if these individuals had unique clinical features that would have suggested the presence of OSAS, we reviewed their case histories. Although four of five patients had symptoms of OSAS prior to transplant, none was suspected of having the diagnosis before their surgery. Excessive daytime sleepiness and loud snoring were noted in all patients, and there were no unusual clinical features that characterized these individuals. Our data indicate that the occurrence of OSAS in heart transplant recipients approximates the prevalence in the general population. Because OSAS may adversely affect cardiac function, we recommend that heart transplantation candidates be screened for a history suggestive of OSAS, and that polysomnography be performed if it is present.

Heart Transplantation↗
PubMed1993

Risk factors for stroke in patients undergoing coronary artery bypass grafting.

Stroke is a significant cause of morbidity and mortality following coronary artery bypass grafting (CABG). Over a 30-month period, 245 consecutive patients undergoing elective CABG were prospectively examined to determine which risk factors might predispose to stroke following surgery. The risk factors evaluated included hypertension, diabetes, hypercholesterolemia, hypertriglyceridemia, smoking, atrial fibrillation, a history of cerebrovascular accident or transient ischemic attack, carotid artery stenosis > 60% documented by duplex scanning, severe atherosclerosis of the ascending aorta, and the presence of ventricular thrombus. Postoperative stroke occurred in five of the 245 patients (2%), four evident immediately on awakening and one on day 7 after surgery. The probable causes of the immediate strokes were atheroembolism in three patients and severe ipsilateral carotid stenosis in one. Hypertensive hemorrhage was responsible for the one case of delayed stroke. In this study, carotid artery stenosis did not presage stroke following CABG, but ventricular thrombus was highly predictive of stroke after surgery.

Aged↗
PubMed1993

Management of complications of Sideris transcatheter devices for atrial septal defect closure.

Various devices that can be inserted transvenously to close an ostium secundum atrial septal defect are undergoing clinical trials. Although these are safe and effective in most instances, they may occasionally dislodge or fail to "button" properly, causing migration and embolization. We report two cases in which the occluder and counteroccluder of the Sideris device for transvenous atrial septal defect occlusion (Custom Medical Devices, Amarillo, Tex.) failed to "button" appropriately, migrating in the right atrium in one patient and embolizing to the pulmonary artery in the second patient. An emergency operation was required to retrieve the device and repair the atrial septal defect.

Cardiac Catheterization↗