Implantable Device Reduces Hospitalizations and Other Risks Associated with Atrial Fibrillation

New research financed by Medtronic Inc. suggests that implantable cardiac resynchronization therapy devices governed by its new algorithms may reduce atrial fibrillation-related complications in patients who have experienced heart failure.

New research financed by Medtronic Inc. suggests that implantable cardiac resynchronization therapy devices (CRT-D) governed by its new algorithms may reduce atrial fibrillation (AF) in patients who have experienced heart failure.

Data from the company’s Adaptive CRT trial show a 61% (p=0.01) lower risk of AF-related problems in patients who received a CRT-D with Medtronic’s AdaptivCRT algorithm instead of conventional biventricular pacing therapy.

Research team members, who presented their data at the CARDIOSTIM/EHRA EUROPACE 2014 conference, also reported a 55% relative reduction in health care utilizations (including hospitalizations as well as emergency department and clinic visits) among patients who used devices with the algorithm.

Subsequent analysis of results from 476 patients in the US and Germany suggested that the decreased health care utilizations would save $315 per American user per year and 65 Euros per German user per year — mostly because of the reduction in hospitalizations.

“The study results are clear in showing that CRT devices with adaptive algorithms reduce the risk of atrial fibrillation’s adverse events and related costs,” said Bernd Lemke, MD, in a news release. Lemke heads the Department of Cardiology at Lüdenscheid Hospital in Germany.

“On an individual level, the algorithm's personalized therapy helps keep more patients out of the hospital. On a system-level, this results in savings and less use of healthcare resources,” he said.

The AdaptivCRT algorithm allows implantable devices to keep adjusting to each user’s heart activity rather than sticking to pre-set patterns of activity.

The Adaptive CRT trial was a prospective, multicenter, randomized, double-blind test that enrolled 522 patients who received a CRT-D. Patients were randomized 2-to-1 between a treatment arm that received the AdaptivCRT algorithm and a control arm that received echocardiographic optimization of the pacing parameters. All patients were evaluated at 6 and 12 months and every 6 months thereafter until study closure. Overall, the Adaptive CRT trial demonstrated non-inferiority of the AdaptivCRT algorithm to echocardiographically optimized CRT.

The new announcement regarding reduced medical costs echoes related news that Medtronic released at the Heart Rhythm 2014 meeting in San Francisco.

Data from the Adaptive CRT trial presented at that conference suggested that Medtronic’s algorithm reduced 30-day hospital readmissions for heart failure by nearly half, and 30-day hospital readmissions for all causes by more than 40%.

A Medtronic press release noted that hospitals themselves would reap much of the savings from such reductions because many health plans no longer pay for readmissions that come less than 30 days after discharge.

Medtronic further announced that the findings from the Adaptive CRT trials had convinced company officials to launch an even larger study, a global trial of 3,000 patients designed to evaluate the superiority of its CRT-Ds in reducing heart failure events and mortality, compared to conventional bi-ventricular pacing.

CRT has shown significant benefits in treating several types of heart problem, but its use appears to lag far behind what current guidelines suggest. Indeed, one large study from 2008 concluded that doctors had failed to provide any form of CRT to more than 60% of all American patients who would likely benefit from it.