A comparison of short- and long-term outcomes for balloon angioplasty and coronary stent placement.

OBJECTIVES: We sought to compare patient outcomes for coronary stent placement and balloon angioplasty. BACKGROUND: Since 1994, the number of patients treated only with balloon angioplasty has decreased nationally, whereas the use of coronary stents as an alternative has grown tremendously. The objectives of this study were to compare short- and long-term survival and subsequent revascularization rates for patients undergoing single-vessel balloon angioplasty and coronary stent placement. METHODS: New York's Coronary Angioplasty Registry was used to identify New York patients undergoing either balloon angioplasty or stent placement between July 1, 1994, and December 31, 1996. Statistical models were used to compare risk-adjusted short- and long-term survival and subsequent coronary artery bypass graft surgery (CABG) and percutaneous coronary interventions (PCIs). RESULTS: No significant differences were found in adjusted in-patient mortality, but patients who had balloon angioplasty were, on average, 1.36 times more likely to have died at any time during the two-year period after the index procedure (p = 0.003). The adjusted in-patient CABG rate was significantly higher for balloon angioplasty (2.72% vs. 1.66%, p<0.0001), and the adjusted two-year CABG rate was also significantly higher for balloon angioplasty (10.81% vs. 7.25%, p<0.001). The adjusted two-year rate for subsequent PCIs was also significantly higher for balloon angioplasty (19.6% vs. 14.3%, p<0.0001). Although measures were taken to eliminate or minimize the effect of selection bias, it should be noted that patients with stents were healthier at hospital admission than patients who had balloon angioplasty. CONCLUSIONS: Stent placement is associated with significantly lower risk-adjusted long-term mortality, CABG and subsequent PCI rates, as compared with balloon angioplasty.

Short- and long-term mortality for patients undergoing primary angioplasty for acute myocardial infarction.

OBJECTIVES: The goal of this study was to learn more about the risk factors and short- and long-term outcomes for primary angioplasty. BACKGROUND: Primary angioplasty (direct angioplasty without antecedent thrombolytic therapy) has been an effective alternative to thrombolytic therapy for patients with acute myocardial infarction (AMI). However, most reported studies have been compromised by small sample sizes and short observation times. METHODS: New York's coronary angioplasty registry was used to identify New York patients undergoing angioplasty within 6 h of AMI between January 1, 1993 and December 31, 1996. Statistical models were used to identify significant risk factors for in-patient and long-term survival and to estimate long-term survival for all patients as well as various subsets of patients undergoing primary angioplasty. RESULTS: The in-hospital mortality rate for all primary angioplasty patients was 5.81%. When patients in preprocedural shock (who had a mortality rate of 45%) were excluded, the in-hospital mortality rate dropped to 2.60%. Mortality rates for all primary angioplasty patients at one year, two years and three years were 9.3%, 11.3% and 12.6%, respectively. Patients treated with stent placement did not have significantly lower risk-adjusted in-patient or two-year mortality rates. CONCLUSIONS: Primary angioplasty is a highly effective option for AMI.

A comparison of three-year survival after coronary artery bypass graft surgery and percutaneous transluminal coronary angioplasty.

OBJECTIVES: The purpose of this study was to compare 3-year risk-adjusted survival in patients undergoing coronary artery bypass graft (CABG) surgery and percutaneous transluminal coronary angioplasty. BACKGROUND: Coronary artery bypass graft surgery and angioplasty are two common treatments for coronary artery disease. For referral purposes, it is important to know the relative pattern of survival after hospital discharge for these procedures and to identify patient characteristics that are related to survival. METHODS: New York's CABG surgery and angioplasty registries were used to identify New York patients undergoing CABG surgery and angioplasty from January 1, 1993 to December 31, 1995. Mortality within 3 years of undergoing the procedure (adjusted for patient severity of illness) and subsequent revascularization within 3 years were captured. Three-year mortality rates were adjusted using proportional hazards methods to account for baseline differences in patients' severity of illness. RESULTS: Patients with one-vessel disease with the one vessel not involving the left anterior descending artery (LAD) or with less than 70% LAD stenosis had a statistically significantly longer adjusted 3-year survival with angioplasty (95.3%) than with CABG surgery (92.4%). Patients with proximal LAD stenosis of at least 70% had a statistically significantly longer adjusted 3-year survival with CABG surgery than with angioplasty regardless of the number of coronary vessels diseased. Also, patients with three-vessel disease had a statistically significantly longer adjusted 3-year survival with CABG surgery regardless of proximal LAD disease. Patients with other one-vessel or two-vessel disease had no treatment-related differences in survival. CONCLUSIONS: Treatment-related survival benefit at 3-years in patients with ischemic heart disease is predicted by the anatomic extent and specific site of the disease, as well as by the treatment chosen.

Identification of preoperative variables needed for risk adjustment of short-term mortality after coronary artery bypass graft surgery. The Working Group Panel on the Cooperative CABG Database Project.

OBJECTIVES: The purpose of this consensus effort was to define and prioritize the importance of a set of clinical variables useful for monitoring and improving the short-term mortality of patients undergoing coronary artery bypass graft surgery (CABG). BACKGROUND: Despite widespread use of data bases to monitor the outcome of patients undergoing CABG, no consistent set of clinical variables has been defined for risk adjustment of observed outcomes for baseline differences in disease severity among patients. METHODS: Experts with a background in epidemiology, biostatistics and clinical care with an interest in assessing outcomes of CABG derived from previous work with professional societies, government or academic institutions volunteered to participate in this unsponsored consensus process. Two meetings of this ad hoc working group were required to define and prioritize clinical variables into core, level 1 or level 2 groupings to reflect their importance for relating to short-term mortality after CABG. Definitions of these 44 variables were simple and specific to enhance objectivity of the 7 core, 13 level 1 and 24 level 2 variables. Core and level 1 variables were evaluated using data from five existing data bases, and core variables only were examined in an additional two data bases to confirm the consensus opinion of the relative prognostic power of each variable. RESULTS: Multivariable logistic regression models of the seven core variables showed all to be predictive of bypass surgery mortality in some of the seven existing data sets. Variables relating to acuteness, age and previous operation proved to be the most important in all data sets tested. Variables describing coronary anatomy appeared to be least significant. Models including both the 7 core and 13 level 1 variables in five of the seven data sets showed the core variables to reflect 45% to 83% of the predictive information. However, some level 1 variables were stronger than some core variables in some data sets. CONCLUSIONS: A relatively small number of clinical variables provide a large amount of prognostic information in patients undergoing CABG.

Association of surgical specialty and processes of care with patient outcomes for carotid endarterectomy.

BACKGROUND AND PURPOSE: Because there is considerable variation in practice patterns and outcomes for carotid endarterectomy (CE), there is a need to study the processes of care that are associated with adverse outcomes. The purpose of this study was to examine the impact of processes of care and surgical specialty on adverse outcomes for CE. METHODS: A retrospective cohort study based on a voluntary CE registry containing 3644 patients undergoing CE between April 1, 1997, and March 31, 1999, in New York hospitals was used in the study. A multivariable statistical model was used to identify significant independent patient risk factors and to examine the association of processes of care and surgical specialty with outcomes after adjustment for differences in patient risk factors. RESULTS: The overall adverse outcome (in-hospital death or stroke) rate was 1.84%. After adjustment for differences in 7 patient risk factors that were significantly related to adverse outcomes, the use of >/=1 specific processes of care (eversion endarterectomy, protamine, or shunts) was found to be associated with lower odds of an adverse outcome relative to patients undergoing CE without the processes (OR=0.42, P=0.006). Similarly, patients undergoing surgery performed by vascular surgeons had lower odds of experiencing an adverse outcome (OR=0.36, P=0.009). Processes of care and surgical specialty were highly correlated with one another. CONCLUSIONS: Processes of care and surgical specialty are significant interrelated determinants of adverse outcome for CE.

Laparoscopic and open cholecystectomy in New York State: mortality, complications, and choice of procedure.

BACKGROUND: With the advent of laparoscopic cholecystectomy patient outcomes and choice of procedure (laparoscopic vs open) are of vital interest. The purpose of this study was to examine the mortality and complication rates for patients undergoing laparoscopic and open cholecystectomy in New York State and to test for differences among hospital peer groups and regions of the state in the tendency to use the laparoscopic approach. METHODS: A population-based, retrospective cohort study of laparoscopic and open cholecystectomy was conducted in which data were analyzed on all 30,968 patients who underwent cholecystectomy as a principal procedure in New York State in 1996. RESULTS: A total of 78.7% of the 30,968 patients who underwent cholecystectomy as a principal procedure in New York State in 1996 underwent laparoscopic cholecystectomy. The mortality rate was lower for laparoscopic cholecystectomy than for the open procedure (0.23% vs 1.90%, P < .0001) and remained significantly lower after patient characteristics related to patient survival (odds ratio 0.34, P < .0001) were controlled for. The prevalence rate of the 8 most common complications among cholecystectomy patients was also much lower among patients undergoing laparoscopic cholecystectomy. Patients undergoing cholecystectomy in public hospitals, Bronx County, and Kings County were found to be significantly less likely to have laparoscopic procedures, and patients undergoing cholecystectomy on Long Island were found to be significantly more likely to have laparoscopic procedures than were other patients in the state. CONCLUSIONS: There are reasonably large differences among hospitals, hospital groups, and regions of the state in the type of cholecystectomy used, even after adjustment for differences in patient comorbidities and indications for type of procedure.

New York State's Cardiac Surgery Reporting System: four years later.

This study examined changes in the risk-adjusted mortality associated with coronary artery bypass grafting procedures performed in New York State during the first 4 years of New York's Cardiac Surgery Reporting System (1989 to 1992). To track performance over time, surgeons and hospitals were subdivided into three groups on the basis of their performance in 1989. The risk-adjusted mortality for each of the three groups was computed for 1992 and compared with their 1989 mortality. The results indicate that all groups of providers exhibited large reductions in the risk-adjusted mortalities, with the groups that showed the highest initial mortalities manifesting the most improvement. However, the group rankings remained the same in 1992 as they were in 1989. For example, when the hospital groups were based on the terciles of risk-adjusted mortality observed in 1989, the risk-adjusted mortality decreased from 2.72% to 2.19% for group 1, from 4.24% to 2.51% for group 2, and from 7.12% to 2.77% for group 3. Notably, the risk-adjusted mortalities of the three groups were all significantly different from one another in 1989, but were not significantly different from one another in 1992. Another interesting finding was that the volume of operations performed by the various provider groups did not change substantially in the 4-year period.

Predictors of mortality for patients undergoing cardiac valve replacements in New York State.

BACKGROUND: The objective of this study was to identify the mortality rates and significant independent risk factors for mortality for each of six valve replacement groups. METHODS: A total of 14,190 patients who underwent valve replacement in New York State from 1995 to 1997 were classified into six major groups and significant independent risk factors for inpatient mortality were identified for each of the groups using stepwise logistic regression. RESULTS: Mortality rates ranged from 3.33% for isolated aortic valve surgical procedures to 18.72% for multiple valve replacements with coronary artery bypass graft operations. The number of years in excess of age 55 was a significant multivariate predictor of mortality for all six groups of patients. Shock was a significant predictor for five of the six groups, and in each of those groups it was the risk factor with the highest odds ratio. CONCLUSIONS: Significant patient risk factors are relatively consistent across different types of valve replacement procedures. The probability of survival from valve surgical procedures is highly dependent on the patient's preoperative profile and the type of valve operation.

Using Medicare claims data to assess provider quality for CABG surgery: does it work well enough?

OBJECTIVES: To assess the relative abilities of clinical and administrative data to predict mortality and to assess hospital quality of care for CABG surgery patients. DATA SOURCES/STUDY SETTING: 1991-1992 data from New York's Cardiac Surgery Reporting System (clinical data) and HCFA's MEDPAR (administrative data). STUDY DESIGN/SETTING/SAMPLE: This is an observational study that identifies significant risk factors for in-hospital mortality and that risk-adjusts hospital mortality rates using these variables. Setting was all 31 hospitals in New York State in which CABG surgery was performed in 1991-1992. A total of 13,577 patients undergoing isolated CABG surgery who could be matched in the two databases made up the sample. MAIN OUTCOME MEASURES: Hospital risk-adjusted mortality rates, identification of "outlier" hospitals, and discrimination and calibration of statistical models were the main outcome measures. PRINCIPAL FINDINGS: Part of the discriminatory power of administrative statistical models resulted from the miscoding of postoperative complications as comorbidities. Removal of these complications led to deterioration in the model's C index (from C = .78 to C = .71 and C = .73). Also, provider performance assessments changed considerably when complications of care were distinguished from comorbidities. The addition of a couple of clinical data elements considerably improved the fit of administrative models. Further, a clinical model based on Medicare CABG patients yielded only three outliers, whereas eight were identified using a clinical model for all CABG patients. CONCLUSIONS: If administrative databases are used in outcomes research, (1) efforts to distinguish complications of care from comorbidities should be undertaken, (2) much more accurate assessments may be obtained by appending a limited number of clinical data elements to administrative data before assessing outcomes, and (3) Medicare data may be misleading because they do not reflect outcomes for all patients.

A longitudinal analysis of the relationship between in-hospital mortality in New York State and the volume of abdominal aortic aneurysm surgeries performed.

This study uses New York State hospital discharge data to examine the relationship between in-hospital mortality for a patient receiving an abdominal aortic aneurysm resection and the volume of aneurysm operations performed in the previous year at the hospital where the operation took place and by the surgeon performing the operation. Previous research on this topic is extended in several respects: (1) A three-year data base is used to examine the manner in which hospital and surgeon volume jointly affect mortality rate and to examine ruptured and unruptured aneurysms separately; (2) a six-year data base is used to study the "practice makes perfect" hypothesis and the "selective referral" hypothesis; and (3) the degree of specialization of high-volume surgeons is contrasted with that of other surgeons. The results demonstrate a significant inverse relationship between hospital volume and mortality rate for unruptured aneurysms. Further, very few surgeons substantially increased their aneurysm surgery volumes in the six-year study period. Weak selective referral effects were found for both surgeons and hospitals, and higher-volume aneurysm surgeons tended to have much higher specialization rates.

Geographic variation in the utilization and choice of procedures for treating coronary artery disease in New York State. Ischaemic Heart Disease Patient Outcomes Research Team (PORT).

OBJECTIVES: To examine geographical variations in rates of coronary artery bypass grafting (CABG) and percutaneous transluminal coronary angioplasty (PTCA) in New York State, and to examine variations in the choice between these two procedures. METHODS: A retrospective analysis of data from the New York registries for CABG and angioplasty was conducted. Rates were compared for 12 different regions of the state to assess geographic variations. To assess variations in the choice of procedure, frequencies of each procedure by region were compared with expected frequencies obtained by a logistic regression model that related procedure performance to various patient risk factors. RESULTS: There was more than a three-fold variation in age/sex adjusted CABG rates and more than a two-fold variation in age/sex adjusted angioplasty rates among regions. The regional percentages of patients undergoing CABG rather than PTCA ranged from 49% to 70%, and most of the disparity was not related to patient risk factors. Instead, the disparity was largely a result of differences in racial composition and the hospitalization rate for myocardial infarctions. CONCLUSIONS: There is considerable regional variation in New York in the tendency to use aggressive cardiac procedures and in the choice of which procedure to use, and these differences are mostly unrelated to patient need.

Predicting inpatient mortality for pediatric trauma patients with blunt injuries: a better alternative.

PURPOSE: The aim of this study was to identify significant independent predictors of inpatient mortality rates for pediatric victims of blunt trauma and to develop a formula for predicting the probability of inpatient mortality for these patients. METHODS: Emergency department and inpatient data from 2,923 pediatric victims of blunt injury in the New York State Trauma Registry in 1994 and 1995 were used to explore the relationship between patient risk factors and mortality rate. A stepwise logistic regression model with P<.05 was developed using survival status asthe dependent variable. Independent variables included are elements of the Pediatric Trauma Score (PTS), additional elements from the Revised Trauma Score (RTS), the motor response and eye opening components of the Glasgow Coma Scale (GCS), age-specific systolic blood pressure, the AVPU score, and 2 measures of anatomic injury severity (the Injury Severity Score [ISS] and the International Classification of Disease, Ninth Revision-based Injury Severity Score [ICISS]). RESULTS: The only significant independent predictors of severity that emerged were the ICISS, no motor response (best motor response = 1) from the GCS, and the unresponsive component from the AVPU score. The statistical model exhibited an excellent fit (C statistic = .964). The specificity associated with the prediction of inpatient mortality rate based on the presence of 1 or more of these risk factors was .926, and the sensitivity was .944. CONCLUSION: The best independent predictors of inpatient mortality rate for pediatric trauma patients with blunt injuries include variables not specifically contained in the PTS or the RTS: ICISS, no motor response (best motor response = 1) from the GCS, and the unresponsive component of the AVPU score.

Setting program standards for New York State's periodic medical review.

This article describes the methodology used to develop program standards for a new periodic medical review/independent professional review (PMR/IPR) in New York State nursing homes. The new program consists of two stages: a first, cursory stage for the purpose of identifying patients to be subjected to a more thorough process review in the second stage. Program standards consist of (1) norms for the percentage of patients failing Stage 1 before a second stage is undertaken in a nursing home and (2) norms for the percentage of patients failing the second stage before the home is subject to corrective action. The actual standards that were developed are also presented.

An evaluation of hospices in the New York State Hospice Demonstration Program.

In response to a New York State legislative directive, the study reported herein was undertaken to evaluate the use of hospice care within the state's Hospice Demonstration Program. Twelve hospice programs, each providing one of three different models of hospice care, were studied. The community-based programs were found to be considerably less costly than both the hospital-based scattered-bed programs and the hospital-based autonomous-unit programs. The costs of all three programs, however, were less than the costs of conventional terminal care. Although satisfaction with all three models was high, it was higher for both kinds of hospital-based programs than for the community-based programs.

Adult day care services in New York State: a comparison with other long-term care providers.

In response to the need for the creation of adult health-oriented day care programs, New York State in 1969 enacted the first state legislation and regulations to govern the operation of such programs. This report categorizes existing New York State nonoccupant programs into four types on the basis of the ratio of total ancillary costs to total direct costs and then compares and assesses their costs. Costs and characteristics of registrants in the four nonoccupant models are also described and contrasted. The report then compares the patient characteristics and costs of nonoccupant programs with those of the most similar long-term care providers in the state, namely, certified home health agencies and health-related facilities.

An evaluation of the quality assurance system for skilled nursing facilities in New York state.

A new quality assurance system for nursing homes was implemented by the New York State Department of Health in 1981 in response to widespread dissatisfaction with the previous survey and Inspection of Care programs. The new program combined the Inspection of Care, which is a patient centered review, and the survey, which is a structurally oriented facility review. In this study, the old and new quality assurance systems are compared with respect to (1) the amount of surveillance staff resources spent on on-site and off-site activities, (2) the types and quantity of deficiency citations issued, and (3) the correction of deficiencies. The results indicate that the new system devotes more resources to on-site activities and identifies more patient care deficiencies, hut also has led to the identification of more repeat deficiencies.

A priority assignment model for standards and conditions in a long term care survey.

Presently a survey document is used in New York State to enforce Federal and State regulatory standards for long term care facilities (skilled nursing facilities and related facilities). This document is used to establish Medicare and Medicaid certification for these facilities. This study describes the creation of a new survey process---a first stage consisting of a screening survey followed, if necessary, by an intensive survey. A priority assignment model which utilizes the judgments of experts from the New York State Office of Health Systems Management (OHSM) has been developed. This model is employed to develop ranks, priority weights and classifications for the various standards and the Federal conditions which the standards comprise (as well as equivalent State regulations). Saaty's Analytical Hierarchy Process is used to obtain the ranks and priority weights. The consistency of the experts' judgements is measured using Kendall's coefficient of agreement. An optimal split algorithm is used to subdivide the standards and conditions according to impact (high, moderate or low) on patient care, health and safety. The results are to be used as a management tool in developing decision rules for defining the scope of the intensive survey on the basis of screening survey results.

An analysis of the cost of providing ancillary services to skilled nursing facility patients in New York State.

Currently, nursing homes can arrange for the provision of ancillary services either by providing the services directly, purchasing the services through contracts and fees, or by outside billings, in which the services are supplied by other providers who then bill Medicaid directly. Frequently, some combination of these three modes of provision is used for each ancillary service. The purpose of this study is to explore ancillary costs in a sample of nursing homes and to determine, to the extent possible, the most cost-efficient means of providing selected ancillary services (physical therapy, radiology and medical staff services). Prior to examining the impact of the mode of provision on cost levels, other facility and patient characteristics that might justifiably affect costs are identified and adjusted for. The results demonstrate that outside billing or purchasing services can be much less expensive than providing the services directly. It is suggested that all ancillary services (outside billings as well as services provided directly through contracts and fees) be included when facility-to-facility cost comparisons are made. This approach should serve as an incentive for nursing homes to seek the most cost-efficient means of providing ancillary services.

A cost-benefit analysis of prior approvals for Medicaid services in New York state.

This study investigates the costs and benefits of a prior approval mechanism instituted by the New York State Health Department to review the need for the provision of selected types of costly health care and services. The review is made prior to the provision of the service and Medicaid payment for the service is contingent upon the result of the review. Costs include program administration and form processing. Benefits include the value of services which are either denied or modified as a result of the prior approval process. The analysis indicates that three of the seven prior approval categories are cost-beneficial without regard to deterrence benefits. For the other four categories, the results of this study have been used to propose new policies.

A Markov sensitivity model for examining the impact of cost allocations in hospitals.

The cost allocation process in hospitals typically entails an accounting step-down procedure whereby costs are allocated from non-revenue producing service centres to revenue centres. The resulting revenue centre costs are then compared with the third party (Blue Cross, Medicare, Medicaid) allowable costs. Any costs in excess of the allowable costs are not reimbursable. This procedure has been conceptualized using a Markov chain in a recent journal article. The purpose of this paper is to demonstrate how the Markov model may be used to assess the impact of various changes in the original data without having to recalculate the entire step-down process via a Markov model or any other procedure. The changes include an alternate step-down model, a different cost allocation basis for one or more service centres, and the expansion or contraction of one or more service centres.