ICD Implant With Same-Day Hospital Discharge Gets an Evidence Base

May 06, 2016

SAN FRANCISCO, CA — It's a case of the evidence base catching up with clinical practice, with a few new wrinkles: same-day discharge is both feasible and safe for many patients who receive an implantable cardioverter defibrillator (ICD) for primary prevention, suggests a prospective US study of a practice that is increasingly common here in large part because of reimbursement restrictions[1]. Prospective studies supporting the practice are in short supply.

The Same-Day Discharge for ICD Implant trial may also represent one of the best attempts at defining which patients are low risk enough to be discharged the same day as implantation and is noteworthy for the routine use of remote monitoring, engaged right after the procedure, to provide an extra edge of safety against lead malfunction or other early complications.

The study also attempted to show whether next-day discharge would cost more than same-day discharge, but it found no significant differences in direct costs attributable to the procedure and care. Counterintuitively, "we were not able to demonstrate a reduction in healthcare utilization," probably because it was measured by hospital cost-to-charge ratios based on limited data from the "opaque processes of hospital billing and reporting," co–principal investigator Dr Ranjit Suri (Mount Sinai School of Medicine, New York, NY) said when presenting the study here at the Heart Rhythm Society (HRS) 2016 Scientific Sessions.

The methodology for determining cost differences in the study was "challenging," Dr Michael R Gold (Medical University of South Carolina, Charleston), who was not affiliated with the study, told heartwire from Medscape. "It's hard to imagine that same-day discharge wouldn't be more cost-effective than keeping them in the hospital." What's "encouraging" about the study is that same-day discharge for low-risk patients getting ICDs "is where we're likely to be going, and it appears to be safe."

Indeed, same-day discharge was noninferior to next-day discharge for the primary end point of procedural complications within 30 days of the procedure. Still, all agree that the study should be interpreted with caution, because its enrollment fell far short of the prespecified target of 600 patients, leaving the study underpowered. Enrollment was slow, Suri said, because current reimbursement practices favoring same-day discharge made it hard to assign patients to next-day discharge.

"In the United States there is a trend toward same-day discharge, but I think that there are also a large number of patients who are not discharged on the same day," Dr Thomas Deering (Piedmont Heart Hospital, Atlanta, GA) said when officiating at a press conference on the study.

There will always be some patients who will need to stay the night, for various reasons, including physician judgment that it's clinically warranted, he said. "Having said that, I think the vast majority of primary-prevention patients who are clinically stable enough to come in as an outpatient can effectively go home as an outpatient if you watch them for a short period of time."

Time for Standardized Criteria

"It would be great to have guidelines" on the subject, Deering said, but one of the study's contributions is that "it gives me information to communicate to a patient that there are data out there now that show you can safely go home."

According to Suri, "Professional societies should be thinking about developing standardized criteria for same-day discharge. These guidelines would help with adoption of this approach," especially "since practice is heading this way" and there likely won't be another same-day-discharge trial.

At the media briefing, Suri observed that adoption of the practice depends on the country and healthcare system. "In Canada, this paper probably means nothing because they're sending everybody home the same day. But for parts of the world where folks are held in the hospital, this would be something where society-driven guidelines would help," he said.

"We've been doing this for 20 years in Canada," according to Dr Andrew Krahn (Heart & Stroke Foundation of British Columbia, Vancouver), who was not affiliated with the study. "It would never occur to us to do this study," he told heartwire . But he acknowledged that same-day discharge for such patients became standard practice without it ever being tested in a trial. The question never addressed, he said, is "who the patients are who don't do well if they are discharged too early."

Suri emphasized that patient selection for the strategy is key and proposed that an ICD-registry–based scoring system would be useful in clinical practice. "From the NCDR-ICD database we were able to identify people who may be at higher risk for periprocedural complications, and they were excluded."

Which Patients Should Go Home the Same Day?

Eligibility for the Same-Day Discharge for ICD Implant trial included a primary-prevention ICD indication, implantation with a single- or dual-chamber device compatible with an internet-based remote-monitoring system, and residence within 50 miles of a hospital emergency department. Excluded were any requiring bridging with unfractionated or low-molecular-weight heparin or who were pacemaker-dependent or had complications through 4 hours after the implant.

Those were "tight" criteria for this initial trial, Suri told heartwire . "There's no reason we can't expand this to a slightly higher-risk group of patients. Having said that, there are patients who must spend a night in the hospital: patients with heart failure, who are frail, don't have the right social structure, live too far away from the hospital, or are getting a cardiac-resynchronization-therapy device for advanced heart failure."

The study's 265 patients were randomized at 25 US sites after chest X ray and interrogation of their implants within about 4 hours of the procedure ruled out any exclusionary issues. Of the cohort, 129 were discharged the same day and 136 the next day; only 88 and 101, respectively, completed the primary follow-up 30 days later.

The randomized groups weren't significantly different at baseline with respect to NYHA class, LVEF, heart-failure etiology, or prevalence of men vs women or whites vs African Americans.

The procedural complication rate was 3.2% and 1.5% for the same-day and next-day strategies, respectively (HR 2.18, 95% CI 0.40–11.91; P=0.37). In the same-day group there were three cases of hematoma and one cardiac perforation; in the next-day group there was one infection and one lead dislodgment.

There were a total of 2674 individual hospital charges, 1218 for same-day patients and 1455 for next-day patients, for a per-patient total of direct costs of $31,771 and $30,437, respectively. Despite the nonsignificant mean differences, costs varied widely within both patient groups.

Importance of Remote Monitoring

"I have done implants without remote monitoring, and I thought it was going to be a crutch," Suri told heartwire . "We started off with the idea that [remote monitoring] would be a safety net. We've evolved into believing it should be the standard of care." Some physicians, he said, "believe in the next-day device check done in the patient's room before discharge, typically in the morning before they go home. This technology [remote monitoring] gives you that information from the patient's home."

And in the trial, he said, immediate remote monitoring "increased physician, patient, and nurse acceptance of this strategy." Quality-of-life assessments of the patients showed that patients had "no anxiety about and were quite accepting of the same-day strategy."

Suri discloses research support and speaking fees from St Jude Medical, consulting for Zoll Medical, speaking fees from Boehringer Ingelheim; and consulting fees from Biosense. His coauthor reports no relevant financial relationships.

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