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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.

Objective: To examine the process and information used by medical directors (MDs) of private health plans to make medical coverage determinations for new medical technologies, and to assess the influence of plan characteristics on the process., Design: Cross-sectional national survey., Participants: Two hundred thirty-one MDs at private health plans representing 66% and 72% of the US population covered by HMOs and indemnity plans, respectively., Measurements: Actual and optimal review process, final decision authority, sources, and evidence used for technology coverage decisions., Results: In 96% of plans, MDs take part in the medical policy review process for new technology. However, MDs have final authority over coverage decisions in only 27% of plans. Indemnity plans are more likely to assert that MDs should be responsible for final decisions, odds ration (OR) = 3.3 (95% confidence interval [95% CI] 1.4, 10). Optimal sources of information of new technology were journals, medical society statements or practice guidelines, and opinions of national experts. Actual sources of information used differed from optimal ones; local experts were used more often than is considered optimal (p < .001). For-profit plans were more likely than nonprofit plans to use national experts, OR 2.5 (95% CI 1.3, 5.0), and practice guidelines, OR 5.0 (95% CI 2.5, 10). Randomized trials (94% of MDs) meta-analyses (61%), and reviews (42%) were considered the best evidence for making coverage decisions. Barriers to making optimal decisions were lack of timely evidence on effectiveness and cost-effectiveness, not legal or regulatory issues; HMO, small, and nonprofit plans were two or three times more likely to list lack of cost-effectiveness data than their counterparts (p < .05)., Conclusions: Although MDs are nearly always involved in the technology evaluation process, a minority of MDs retain final authority over coverage decisions. Evidence from strong scientific research designs is the most frequently cited basis for decisions, but there is need for more timely, rigorous scientific evidence on medical interventions. How a health plan evaluates a new medical technology for coverage varies with identifiable plan characteristics.