The cost of long-term LVAD implantation.

BACKGROUND: With increasing use of left ventricular assist devices (LVAD) worldwide, the economics of LVAD implantation have become an important focus of concern. Although these devices have high unit costs, they are the only hope for survival for a large group of terminally ill patients and are likely to have an expansion in indications for use. METHODS: We calculated the costs associated with long-term LVAD implantation. We used the ratio of cost-to-charges method to calculate hospital costs per resource category, market prices for drugs and device, and payments for physician services. RESULTS: Based on our experience with "bridge-to-transplantation" patients, we estimated average first-year costs to be $222,460 including professional fees and $192,154 excluding professional fees. The latter figure is comparable to average first-year costs for cardiac transplantation, which is $176,605 without professional fees at our institution. CONCLUSIONS: The costs of LVAD therapy will change after the first year of implantation, and device reliability and longevity will be important factors in determining these costs. Should the costs of LVAD therapy continue to track those of cardiac transplantation, devices will be cost-effective only if they offer similar efficacy to cardiac transplantation.

Using faculty development to solve a problem of evaluation and management coding: a case study.

Compliance with billing and coding rules put forth by the Health Care Finance Administration (HCFA) is a challenge for practicing physicians, including those in academic settings. The authors, members of the academic practice at Wayne State University School of Medicine, Department of Family Medicine, designed and delivered a comprehensive curriculum as part of the practice's faculty development initiative surrounding the coding challenge. The authors defined outcomes expected on the way to achieving 100% compliance with HCFA's guidelines. Their curriculum covered topics of coding theory, chart auditing for coding, team building, effective meetings, and structured problem solving. The curriculum was delivered from January to May 1998. Chart audits of 251 charts (office notes) from before the intervention and 263 charts from after the intervention were performed to evaluate differences in coding accuracy. Errors were significantly reduced. The total error rate dropped from 50.2% to 31.1% (p < .05). Overcoding errors were reduced by one third (29.1% versus 19.7%), while undercoding errors were reduced by half (16.3% versus 8.4%). Other errors fell from 4.7% to 3%. The approach of defining and developing work teams and then using standard quality improvement tools may be an effective way to improve compliance with HCFA billing and coding rules. In addition, faculty development can be incorporated into the process of solving a problem that faces a faculty.

Six-year experience of caring for forty-four patients with a left ventricular assist device at home: safe, economical, necessary.

OBJECTIVE: With increasing numbers of implantations, left ventricular assist device programs can put a financial strain on a hospital unless an efficient and safe outpatient program is developed. However, the left ventricular assist device is not widely recognized in the medical community as being reliable enough to support a patient at home. We reviewed our experience with these patients at home to assess the safety and the benefits of such a program. METHODS: Our institutional 6-year experience with 90 consecutive recipients of a wearable left ventricular assist device was analyzed. RESULTS: Forty-four (49%) of the 90 patients who received TCI vented-electric left ventricular assist devices (Thermo Cardiosystems, Inc, Woburn, Mass) were discharged, spending a total of 4546 days (12.5 years) at home with an average of 103 +/- 16 days of outpatient support (range 9-436 days). Of these 44 patients, all were successfully bridged to transplantation (42 patients, 96%) or planned explantation (2 patients, 4%). None of the outpatients died. The cumulative events per outpatient month were 0.020 for bleeding, 0.053 for device infection, 0.0068 for thromboembolus, and 0.020 for major malfunctions. Our estimated average cost to bridge a patient to transplantation or explantation once discharged is $13,200 and as an inpatient over the same length of time, including only room and board, is $165,200. Thirty percent of outpatients were able to return to work or school, 33% to sexual activity, and 44% to driving. All outpatients performed activities of daily living. CONCLUSION: Current left ventricular assist device technology provides effective and economical outpatient support and is associated with limited morbidity and a satisfactory quality of life.

Teaching practice management during residency.

BACKGROUND AND OBJECTIVES: Practice management is a required component in family practice residency education. A few studies have reported that recently graduated primary care physicians indicated that their practice management training was inadequate. Our study describes the current nature of practice management education in family practice residencies and the perceptions of residency directors about the effectiveness of their program's practice management curriculum. METHODS: Surveys were mailed to 421 family practice residency directors, who were asked about their program's curriculum approach to teaching practice management, as well as their evaluation of the effectiveness of the curriculum. After two mailings, 213 surveys (51%) were returned. RESULTS: Eighteen percent of the respondents provided less than the required 60 hours of practice management curricular time. Residency directors indicated that managed care has had a significant effect on their curriculum. Directors' ratings of the effectiveness of their curriculum were associated with more curricular time and specifically with active learning activities. Although directors reported that managed care had affected how they teach practice management, managed care penetration was not associated with perceived curriculum effectiveness. CONCLUSIONS: Family practice residency program directors described a variety of approaches to teaching practice management. Active learning strategies seem to be important curricular components, although further study is needed about the most-effective methods to prepare physicians for post-residency practice.

Cost-effectiveness of coronary artery bypass surgery in octogenarians.

OBJECTIVE: The objective of this retrospective cohort study was to determine whether coronary artery bypass graft (CABG) surgery is effective and cost-effective relative to medical management of coronary artery disease (CAD) in the elderly. SUMMARY BACKGROUND DATA: The aging of the U.S population and the improvements in surgical techniques have resulted in increasing numbers of elderly patients who undergo this surgery. The three randomized, controlled trials (RCTs) that established the efficacy of CABG surgery completed patient enrollment from 19 to 24 years ago excluded patients older than 65 years. Although information regarding outcomes of CABG in this population is mainly available in case series, a major lacuna exists with respect to information on quality of life and cost effectiveness of surgery as compared with medical management. METHODS: The authors retrospectively formed surgical and medically managed cohorts of octogenarians with significant multivessel CAD. More than 600 medical records of patients older than 80 years who underwent angiography at our institution were reviewed to identify 48 patients who were considered reasonable surgical candidates but had not undergone surgery. This cohort was compared with 176 patients who underwent surgery. RESULTS: The cost per quality-adjusted life year saved was $10,424. At 3 years, survival in the surgical group was 80% as compared with 64% in the entire medical cohort and 50% in a smaller subset of the medical cohort. Quality of life in patients who underwent surgery was measurably better than that of the medical cohort with utility index scores, as measured by the EuroQoL, (a seven-item quality of life questionnaire) of 0.84, 0.61, and 0.74, respectively. CONCLUSIONS: Performing CABG surgery in octogenarians is highly cost-effective. The quality of life of the elderly who elect to undergo CABG surgery is greater than that of their cohorts and equal to that of an average 55-year-old person in the general population.

Treatment of endstage heart disease with mechanical circulatory assistance.

A great number of patients suffer and die from the sequelae of acute and chronic heart failure each year. Although advances in medical and surgical therapy have benefited many of these patients, the majority suffer from disease refractory to any definitive therapy. For these patients, cardiac transplantation is the only remaining hope. Unfortunately, because of the increasing demand for donor organs in the face of a fixed and limited supply, this option is only available to a small percentage of these patients. Even in patients accepted for transplantation, a significant waiting list mortality has been observed. A variety of ventricular assist devices (VAD) have been developed since the first successful case of mechanical cardiac assistance over 30 years ago. These devices differ in basic mechanical function, method of insertion, and degree of implantability, and thus have different indications and potential applications. While the intra-aortic balloon pump and centrifugal pumps are effective short-term support modalities, extracorporeal and implantable pulsatile devices have been used successfully for long-term support of patients with reversible and non-reversible cardiac failure. These pumps have most commonly been utilized as bridges to transplantation, but increasing clinical experience has supported the notion of long-term mechanical assistance as a definitive therapy for endstage heart disease. While complications, particularly infection and thromboembolism, pose significant challenges and long-term device reliability remains to be fully determined, available implantable devices seem capable of providing effective long-term support. As data is obtained from currently ongoing trials comparing VAD support to medical therapy for endstage heart failure, ethical and economic issues will assume increasing importance.

TQM in health care: mistaken identity?

Total Quality Management is a powerful tool in health care today. The definition of quality improvement in the medical literature focuses on improving patient outcomes. However, most quality initiatives in the health care field focus on improving productivity, cost-effectiveness, market share, employee morale, and efficiencies of processes. This disparity between the medical definition of quality and the actual application of quality improvement may have the effect of alienating many physicians, the very people who must be involved. The semantics are important to address in a TQM initiative.

Bridge experience with long-term implantable left ventricular assist devices. Are they an alternative to transplantation?

BACKGROUND: If long-term use of left ventricular assist devices (LVADs) as bridges to transplantation is successful, the issue of permanent device implantation in lieu of transplantation could be addressed through the creation of appropriately designed trials. Our medium-term experience with both pneumatically and electrically powered ThermoCardiosystems LVADs is presented to outline the benefits and limitations of device support in lieu of transplantation. METHODS AND RESULTS: Detailed records were kept prospectively for all patients undergoing LVAD insertion. Fifty-eight LVADs were inserted over 5 years, with a survival rate of 74%. Mean patient age was 50 years, and duration of support averaged 98 days. Although common, both preexisting infection and infection during LVAD support were not associated with increased mortality or decreased rate of successful transplantation. Thromboembolic complications were rare, occurring in only three patients (5%) despite the absence of anticoagulation. Ventricular arrhythmias were well tolerated in all patients except in cases of early perioperative right ventricular failure, with no deaths. Right ventricular failure occurred in one third of patients and was managed in a small percentage by right ventricular assist device (RVAD) support and/or inhaled nitric oxide therapy. There were no serious device malfunctions, but five graft-related hemorrhages resulted in two deaths. Finally, a variety of noncardiac surgical procedures were performed in LVAD recipients, with no major morbidity and mortality. CONCLUSIONS: Over all, our medium-term experience with implantable LVAD support is encouraging. Although additional areas of investigation exist, improvements in patients selection and management together with device alterations that have reduced the thromboembolic incidence and facilitated patient rehabilitation lead us to believe that a prospective, randomized trial is indicated to study the role that LVADs may have as an alternative to medical management.

Cardiac transplantation for endstage heart disease.

Orthotopic heart transplantation (OHT), first accomplished in 1967, is currently performed in over 2000 patients per year at hundreds of centers worldwide. Selection criteria include end-stage heart failure with a limited life expectancy, intractable angina due to inoperable coronary artery disease, malignant ventricular arrhythmias refractory to maximal therapy, and unresectable cardiac tumors. While early immunosuppression was based on azathioprine and steroids, the current success of OHT is based on the addition of cyclosporine A (CyA) to this regimen. At Columbia-Presbyterian Medical Center, steroids and azathioprine are given perioperatively, and cyclosporine (OKT3 in patients with renal dysfunction) begun postoperatively. Survival rates at our institution parallel those reported by other centers, with 1- and 5-year actuarial survival of 85% and 70%, respectively. The most frequent causes of early mortality are allograft rejection and infection, while graft coronary artery disease (CAD) is responsible for most deaths occurring after the first post-transplant year. Regular endomyocardial biopsy is used to monitor for rejection, which occurs in 55% of patients within the first year. Mild or asymptomatic rejection is managed with oral steroids, followed by intravenous steroids and/or OKT3 or anti-thymocyte globulin (ATG) in refractory cases. Graft CAD occurs in 45% of patients surviving 3 years, and may require retransplantation. Heart transplantation is a proven, effective form of cardiac replacement. The recent trend of increasingly critically ill transplant candidates, however, has driven the costs of OHT to unprecedented levels. This issue, as well as the continuing organ short-age and current developments in mechanical cardiac assistance and xenotransplantation will undoubtedly assure a continually evolving role for cardiac transplantation in the treatment of endstage heart disease.

Immunologic assessment of patients treated with bovine fibrin as a hemostatic agent.

Twenty-one cardiothoracic surgical patients have been treated with fibrin as a topical hemostatic/sealing agent, prepared from bovine fibrinogen clotted with bovine thrombin. Serum samples have been collected before treatment with fibrin and postoperatively between 1 and 9 days, 3 and 12 weeks, and 6 and 8 months. The titers of anti-bovine fibrinogen antibodies, measured by ELISA specific for immunoglobulins IgG or IgM, increased to maximal values after about 8 or 6 weeks, respectively. After 8 months, IgG titers were on average 20-fold lower than the mean maximal value, while IgM titers returned to the normal range. IgG was the predominant anti-bovine fibrinogen immunoglobulin as documented by ELISA, affinity chromatography and electrophoresis. Anti-bovine fibrinogen antibodies present in patients reacted readily with bovine fibrinogen, but did not cross-react with human fibrinogen as measured by ELISA or by immunoelectrophoresis. A significant amount of antibodies against bovine thrombin and factor V has been found, many cross-reacting with the human counterparts. No hemorrhagic or thrombotic complications, or clinically significant allergic reactions, occurred in any patient, in spite of antibody presence against some bovine and human coagulation factors. The treatment of patients with bovine fibrin, without induction of immunologic response against human fibrinogen, appeared to be an effective topical hemostatic/sealing measure.

Multivariate analysis of factors affecting waiting time to heart transplantation.

BACKGROUND: The growing clinical success of cardiac transplantation has resulted in a dramatic increase in the number of patients referred and subsequently listed for cardiac transplantation. Paradoxically, in the presence of a limited donor organ pool, such expansion has increased both the waiting time for transplantation and the number of patients dying while on the waiting list. METHODS: We performed univariate and multivariate analyses of the waiting times of 301 patients listed for transplantation using a Cox proportional hazards model to evaluate the simultaneous effect of multiple variables on the waiting time of heart transplant candidates. Variables considered included age, sex, race, blood type, weight at listing, United Network for Organ Sharing (UNOS) status at listing, UNOS status at transplantation, and proportion of time on the waiting list as UNOS status 1. RESULTS: The mean waiting time for patients ultimately having transplantation was 170.2 +/- 206.0 days; the median waiting time was 103.5 days. Age, sex, weight, blood type, and percent of time as UNOS status 1 all had a significant impact on waiting time in the univariate analysis. By multivariate analysis, proportion of time as UNOS status 1, lower weight at listing, and blood type AB were all highly associated as predictors of a shorter waiting time. Weight at listing represented a continuous variable whose risk ratio for a shorter waiting time correlated in such a way that the risk of a longer waiting time increased 2.3 per 22.5-kg (50-pound) increase in weight. Blood types A and B, although associated with a shorter waiting time, correlated less strongly than the other three variables. CONCLUSIONS: Our findings from this multivariate analysis demonstrate that UNOS status, blood type, and weight were the variables that most strongly affected overall waiting time for transplantation. It is our hope to define more accurately a group of patients with both a high likelihood of a long waiting time and a prohibitive risk of death while on the waiting list, who therefore may benefit from surgical alternatives to transplantation.

Two decades of cardiac transplantation at the Columbia-Presbyterian Medical Center: 1977-1997.

Since its inception in 1977, the Cardiac Transplantation Service at Columbia-Presbyterian Medical Center has performed more than 900 heart transplant procedures, with a one-year survival rate of approximately 80%, and a 5-year survival rate of approximately 60%. Throughout our 20-year experience, the criteria for eligibility both donors and recipients has widened to include older and "reanimated" donors for selected recipients, as well as an extensive experience with recipients bridged to transplantation with mechanical assist devices. Of particular interest in recent years has been the need for additional therapy for the highly sensitized transplant candidate and ultimate transplant recipient, whose immunosuppressive regimen must be continuously monitored and modified to ensure graft survival. In light of the persistent donor organ crisis, continued efforts are being developed to more accurately characterize the transplant candidate waiting list in order to identify those patients who may be better served by either medical management or an alternative surgical procedure to transplantation, including high-risk coronary revascularization and mechanical or biological assistance. Current research interests at CPMC include left ventricular assist devices, xenotransplantation, and management of both transplant coronary artery disease and immunologic sensitization. Ongoing investigations in these and other areas of transplantation have been established to encourage continued growth both within the field and at CPMC through the 21st century.

The implantable defibrillator: an electronic bridge to cardiac transplantation.

BACKGROUND: Sudden cardiac death (SCD) is common among patients awaiting heart transplantation. Medical management of SCD may fail due to lack of efficacy or adverse side effects. The implantable cardioverter-defibrillator (ICD) may extend patient survival until a donor heart is available. METHODS AND RESULTS: We reviewed 16 patients listed for transplantation between November 1988 and October 1991 who underwent ICD implantation for ventricular arrhythmias refractory to medical management. Mean age was 51.4 +/- 11.4 years (range, 19-66 years), mean ejection fraction was 15.4 +/- 3.0% (range, 10-21%), and underlying cardiomyopathy was ischemic (12 patients), valvular (one patient), or dilated (three patients). There was no mortality from ICD insertion. Fourteen patients were discharged before transplantation, and two patients remained in the hospital until transplantation. Twelve patients underwent transplantation after a mean of 155.7 +/- 113.7 days (range, 3-319) on the transplant list. The ICD delivered shocks for tachyarrhythmia associated with near syncope in 15 of 16 patients. ICD shocks numbered > 10 in five patients, 5-9 in three patients, and 1-4 in seven patients. There was no morbidity or mortality attributed to patch electrode removal. CONCLUSIONS: We conclude that the ICD can be implanted with minimal morbidity in transplant candidates, allowing the patients to be ambulatory and to leave the hospital while awaiting heart transplantation. In patients at risk of SCD, the ICD is an effective electronic bridge to transplantation.

Evaluation of surgical procedures. Changing patterns of patient selection and costs in heart transplantation.

During the past 4 years we have observed a marked increase in costs of heart transplantation in our center. This trend coincides with a shift in our recipient population toward the more severely ill patients. The percentage of patients bound for the intensive care unit has doubled. In analyzing the components of cost, we find that the length of stay, both in special care and regular nursing units, accounts for most of the cost increase. In our study of outcomes we find no significant difference in survival, at 1 month and 1 year, between recipients operated on from the intensive care unit and those not in intensive care. We find that at 1 year after transplantation, approximately 80% of patients are rehabilitated, which we define as the ability to work or to go to school. Only 20% of patients are off disability rolls, however, primarily because of problems related to insurance and the cost of continuing care, including drugs. We conclude that the comprehensive evaluation of surgical procedures requires an approach that balances costs with results on a continuing and long-term basis.