Results from a randomized, controlled clinical trial that evaluated the safety and cost effectiveness of same-day discharge for elective implantable cardioverter-defibrillator (ICD) procedures may reassure centers that already provide the option as well as those considering it. But whether the approach meets the promise of lowering costs is anyone’s guess.
Practice meets proof
The standard of care in the United States for ICD implantation for primary prevention of sudden cardiac death generally calls for overnight observation to ensure that the patient isn’t at risk of implant-related complications. But technological advancements and the adoption of techniques that reduce the risk of complications should allow physicians to shorten that timeline to a same-day procedure in selected low-risk patients. So reasoned Ranjit Suri, MD, president of Heart Rhythm Associates and a cardiologist at the Mount Sinai School of Medicine in New York City.
At the Heart Rhythm Society’s (HRS) 2016 scientific sessions in San Francisco, Suri unveiled preliminary findings from a randomized, controlled clinical trial he co-led that compared the safety and cost effectiveness of same-day discharge with an overnight stay in low-risk ICD patients who did not require bridging anticoagulation using heparin. The multicenter trial had been given a green light after Suri and colleagues proved its feasibility in a single-center pilot study (J Cardiovasc Electrophysiol 2012;23:1123-1129).
The trial showed that same-day discharge was as safe as next-day discharge, with a procedural complication rate of 3.2 percent vs. 1.5 percent (Heart Rhythm 2016;13:1371-1372). Counter to expectations, though, they found no statistically significant difference in overall costs per patient between the groups.
“The trial largely confirmed what has been a growing practice in the United States,” says HRS President Michael R. Gold, MD, PhD, director of the cardiology division and a professor at the Medical University of South Carolina in Charleston. “It is an important piece of information that adds to our growing comfort. The safety of these devices continues to improve and the safety of the procedure continues to improve as the technology improves and the monitoring capability improves.”
With advancements in remote monitoring, the technology leapfrogged forward between the pilot’s enrollment period of 2007 to 2008 and the clinical trial’s window of 2014 and 2016. “Remote monitoring was in its infancy during the pilot,” Suri observes, and it was hobbled by transmission limitations and patients’ technical skills. The clinical trial, on the other hand, required implantation of an ICD that was compatible with St. Jude Medical’s Merlin@home transmitter. “We eliminated that by having remote monitoring using a wireless system independent of the patient’s home phone or technological capabilities.” Suri points out all the major vendors offer similar attributes.
Short of the goal
The trial originally set a target enrollment of 600 participants, but it was stopped early in January with an initial sample size of 313. Of those, only 265 patients were randomized, leaving the study underpowered. Among other challenges, temporal trends in ICD utilization led to a smaller pool of potential candidates. “The overall ICD volumes have gone down,” Suri says.
The rate for primary ICD implantations in the United States skyrocketed before the pilot study, climbing from 6.1 per 100,000 person population in 1993 to 46.2 in 2006, according to an analysis of Nationwide Inpatient Sample data (Pacing Clin Electrophysiol 2010;33:705-711). Another Nationwide Inpatient Sample analysis found a similar trend, with ICD implantations growing from 95,062 in 2003 to a peak of 143,262 in 2006 (Clin Cardiol 2016;39:63-71). That total steadily declined after 2006, dropping to 86,457 by 2011.
Other physician and hospital factors also may have helped stack the deck against the trial. The two-midnight rule, which the Centers for Medicare
& Medicaid Services established in fiscal year 2014, may have changed practices. In its June 2015 report to Congress, the Medicare Payment Advisory Commission noted that concerns over denial of payments flagged by Medicare recovery audit contractors (RACs) for short inpatient stays prompted some hospitals to increase their use of outpatient observations.
The report also noted that the diagnosis-related group (DRG) code for cardiac arrhythmias and conduction disorders