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      Cardiac Device Implantation in the United States from 1997 through 2004: A Population-based Analysis

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          Abstract

          OBJECTIVE

          Use of cardiac devices has been increasing rapidly along with concerns over their safety and effectiveness. This study used hospital administrative data to assess cardiac device implantations in the United States, selected perioperative outcomes, and associated patient and hospital characteristics.

          METHODS

          We screened hospital discharge abstracts from the 1997–2004 Healthcare Cost and Utilization Project Nationwide Inpatient Samples. Patients who underwent implantation of pacemaker (PM), automatic cardioverter/defibrillator (AICD), or cardiac resynchronization therapy pacemaker (CRT-P) or defibrillator (CRT-D) were identified using ICD-9-CM procedure codes. Outcomes ascertainable from these data and associated hospital and patient characteristics were analyzed.

          MEASUREMENTS AND MAIN RESULTS

          Approximately 67,000 AICDs and 178,000 PMs were implanted in 2004 in the United States, increasing 60% and 19%, respectively, since 1997. After FDA approval in 2001, CRT-D and CRT-P reached 33,000 and 7,000 units per year in the United States in 2004. About 70% of the patients were aged 65 years or older, and more than 75% of the patients had 1 or more comorbid diseases. There were substantial decreases in length of stay, but marked increases in charges, for example, the length of stay of AICD implantations halved (from 9.9 days in 1997 to 5.2 days in 2004), whereas charges nearly doubled (from $66,000 in 1997 to $117,000 in 2004). Rates of in-hospital mortality and complications fluctuated slightly during the period. Overall, adverse outcomes were associated with advanced age, comorbid conditions, and emergency admissions, and there was no consistent volume–outcome relationship across different outcome measures and patient groups.

          CONCLUSIONS

          The numbers of cardiac device implantations in the United States steadily increased from 1997 to 2004, with substantial reductions in length of stay and increases in charges. Rates of in-hospital mortality and complications changed slightly over the years and were associated primarily with patient frailty.

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          Most cited references43

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          Comorbidity measures for use with administrative data.

          This study attempts to develop a comprehensive set of comorbidity measures for use with large administrative inpatient datasets. The study involved clinical and empirical review of comorbidity measures, development of a framework that attempts to segregate comorbidities from other aspects of the patient's condition, development of a comorbidity algorithm, and testing on heterogeneous and homogeneous patient groups. Data were drawn from all adult, nonmaternal inpatients from 438 acute care hospitals in California in 1992 (n = 1,779,167). Outcome measures were those commonly available in administrative data: length of stay, hospital charges, and in-hospital death. A comprehensive set of 30 comorbidity measures was developed. The comorbidities were associated with substantial increases in length of stay, hospital charges, and mortality both for heterogeneous and homogeneous disease groups. Several comorbidities are described that are important predictors of outcomes, yet commonly are not measured. These include mental disorders, drug and alcohol abuse, obesity, coagulopathy, weight loss, and fluid and electrolyte disorders. The comorbidities had independent effects on outcomes and probably should not be simplified as an index because they affect outcomes differently among different patient groups. The present method addresses some of the limitations of previous measures. It is based on a comprehensive approach to identifying comorbidities and separates them from the primary reason for hospitalization, resulting in an expanded set of comorbidities that easily is applied without further refinement to administrative data for a wide range of diseases.
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            Combined cardiac resynchronization and implantable cardioversion defibrillation in advanced chronic heart failure: the MIRACLE ICD Trial.

            Cardiac resynchronization therapy (CRT) through biventricular pacing is an effective treatment for heart failure (HF) with a wide QRS; however, the outcomes of patients requiring CRT and implantable cardioverter defibrillator (ICD) therapy are unknown. To examine the efficacy and safety of combined CRT and ICD therapy in patients with New York Heart Association (NYHA) class III or IV congestive HF despite appropriate medical management. Randomized, double-blind, parallel-controlled trial conducted from October 1, 1999, to August 31, 2001, of 369 patients with left ventricular ejection fraction of 35% or less, QRS duration of 130 ms, at high risk of life-threatening ventricular arrhythmias, and in NYHA class III (n = 328) or IV (n = 41) despite optimized medical treatment. Of 369 randomized patients who received devices with combined CRT and ICD capabilities, 182 were controls (ICD activated, CRT off) and 187 were in the CRT group (ICD activated, CRT on). The primary double-blind study end points were changes between baseline and 6 months in quality of life, functional class, and distance covered during a 6-minute walk. Additional outcome measures included changes in exercise capacity, plasma neurohormones, left ventricular function, and overall HF status. Survival, incidence of ventricular arrhythmias, and rates of hospitalization were also compared. At 6 months, patients assigned to CRT had a greater improvement in median (95% confidence interval) quality of life score (-17.5 [-21 to -14] vs -11.0 [-16 to -7], P =.02) and functional class (-1 [-1 to -1] vs 0 [-1 to 0], P =.007) than controls but were no different in the change in distance walked in 6 minutes (55 m [44-79] vs 53 m [43-75], P =.36). Peak oxygen consumption increased by 1.1 mL/kg per minute (0.7-1.6) in the CRT group vs 0.1 mL/kg per minute (-0.1 to 0.8) in controls (P =.04), although treadmill exercise duration increased by 56 seconds (30-79) in the CRT group and decreased by 11 seconds (-55 to 12) in controls (P<.001). No significant differences were observed in changes in left ventricular size or function, overall HF status, survival, and rates of hospitalization. No proarrhythmia was observed and arrhythmia termination capabilities were not impaired. Cardiac resynchronization improved quality of life, functional status, and exercise capacity in patients with moderate to severe HF, a wide QRS interval, and life-threatening arrhythmias. These improvements occurred in the context of underlying appropriate medical management without proarrhythmia or compromised ICD function.
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              Increasing rates of cardiac device infections among Medicare beneficiaries: 1990-1999.

              Although cardiac devices have been found to reduce symptoms and mortality rates in appropriate patient populations, the implications of certain important risks, such as infection, are incompletely understood. The purpose of this study was to use a large population-based database to define the population that is at risk for cardiac device infections, determine the prevalence of device infections, and study changes in the rates of cardiac device implantation and infection in the past decade. Patients with cardiac device implantations and infections were identified with claims files from the Health Care Finance Administration for Medicare beneficiaries from January 1, 1990, through December 31, 1999. Rates of implantation of cardiac devices were determined. Time trend analyses were performed to determine the significance of the observed change in rates. Cardiac device implantation rates increased from 3.26 implantations per 1000 beneficiaries in 1990 to 4.64 implantations per 1000 beneficiaries in 1999, which represents an increase of 42% in 10 years (P for trend <.001). Cardiac device infections showed a larger increase, from 0.94 device infections per 1000 beneficiaries in 1990 to 2.11 device infections per 1000 beneficiaries in 1999, which represents an increase of 124% during the study period (P for trend <.001). During the previous decade, there was a significant increase in both cardiac device implantations and infections in elderly patients, although the increase in the rates of device infections was substantially higher. Additional studies are needed to better understand the relationship and timing between cardiac device implantation and infection.
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                Author and article information

                Contributors
                chunliu.zhan@ahrq.hhs.gov
                Journal
                J Gen Intern Med
                Journal of General Internal Medicine
                Springer-Verlag (New York )
                0884-8734
                1525-1497
                19 December 2007
                January 2008
                : 23
                : Suppl 1
                : 13-19
                Affiliations
                [1 ]Center for Outcomes and Evidence, Agency for Healthcare Research and Quality, Rockville, MD USA
                [2 ]Center for Delivery, Organization, and Markets, Agency for Healthcare Research and Quality, Rockville, MD USA
                Article
                392
                10.1007/s11606-007-0392-0
                2359586
                18095038
                2fa6efe7-a5fc-4000-b26c-362b174220f4
                © Society of General Internal Medicine 2007
                History
                Categories
                Original Article
                Custom metadata
                © Society of General Internal Medicine 2008

                Internal medicine
                pacemaker,icd-9-cm,cardiac resynchronization therapy,implantable cardioverter-defibrillator,administrative data

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