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Remote Monitoring, a New Paradigm for Cardiac Implanted Devices?

— Patients using RM report less healthcare utilization and better survival rates.

Last Updated May 18, 2015
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BOSTON -- Patients who used the remote monitoring (RM) function of their cardiovascular implantable electronic devices (CIEDs) had less healthcare utilization and better survival than those without RM according to a pair of studies.

"For every 100,000 patients years, use of RM is associated with 9,810 fewer hospitalizations, 119,000 fewer days in hospital, and $370,270,000 lower hospital payments," reported , from Duke University, at a late-breaking session at the .

Action Points

  • Patients using remote monitoring of their cardiac implantable electronic devices had fewer hospitalizations, shorter hospital lengths of stay, and lower healthcare utilization costs.
  • Reduced hospitalizations were most likely in patients with heart failure and in patients with atrial fibrillation.

The second study was published concurrently in the Journal of the American College of Cardiology (JACC).

Taken together, the results underscore released this week by the Heart Rhythm Society recommending that RM become standard of care for patients with cardiovascular implantable electronic devices (CIEDs).

Piccini's nationwide, retrospective study used a large, real-world cohort which included 92,566 patients (average age 72 years) who were implanted with pacemakers (PM), implantable cardioverter-defibrillators (ICDs), or cardiac resynchronization therapy (CRT) devices from any manufacturer.

The cohort, drawn from MarketScan Commercial and Medicare Supplemental (MS) claims databases (2008-2013), included about one-third of the patients, who had RM as well as clinic visits (n=34,259), while two-thirds had no RM and clinic visits only (n=58,307).

PM and ICD patients made up the majority of the group (n=54,520 and n=27,816 respectively), of whom 29% and 49% had RM. Among patients with CRT devices, most (n=9,125) had a CRT pacemaker with a 51% rate of RM, while 1,105 had a CRT pacemaker/defibrillator (CRT-D) and 27% RM rate.

The primary outcome of the study was all-cause hospitalizations "because of its nature as a robust endpoint, and because noncardiovascular conditions often precipitate arrhythmias, such as flares of chronic obstructive pulmonary disease and other conditions like pneumonia," said Piccini.

And even though the RM and non-RM groups were similar in terms of baseline characteristics and follow-up frequency, patients with RM had a significantly lower cumulative incidence of all-cause hospitalization regardless of their device type.

"Following adjustment, use of remote monitoring was associated with an 18% reduction in all-cause hospitalization," (hazard ratio [HR] 0.82, P<0.001), said Piccini. "And in those patients who were hospitalized, those in the RM group had a 2.8-day lower mean length of stay compared with those without RM (P<0.001).

While the association between lower risk of all-cause hospitalization was "largely preserved across all device types," the difference between RM and non-RM patients was greatest among those using ICDs and CRT-Ds (HR 0.74 and 0.72 respectively, P<0.001 for both), he reported.

The study also found that RM was associated with an overall 30% reduction in hospitalization costs compared with non-RM -- translating to $3,700 less per patient year (P<0.001).

Again, the magnitude of savings was highest among ICD and CRT-D users (43% and 45%, respectively, P<0.001 for both), he said.

Secondary endpoints of the study included heart failure (HF) hospitalizations in patients with prior HF, 30-day HF rehospitalizations, and stroke hospitalization in patients with prior atrial fibrillation.

For all of these endpoints, RM was associated with a significantly reduced risk of hospitalization and significantly reduced hospitalization costs compared with no RM, reported Piccini.

Since fewer than half of patients in this study used RM, this is "a major opportunity for quality improvement in the U.S. healthcare system," he commented.

Another study co-authored by Piccini and , Cleveland Clinic in Ohio, and published simultaneously in the JACC, struck the message home still further.

In that study, among 371,217 consecutive patients receiving new CIEDs from one manufacturer (St. Jude Medical, Sylmar, Ca.), RM was associated with improved survival compared with no RM, and the effect increased with greater adherence to RM.

Using four data sources (device implant registration, device RM, postal code sociodemographic data, and the U.S. Social Security Death Master File), the investigators tracked patients' level of RM adherence and showed that high adherence (defined as weekly maintenance records sent to the server ≥75% of their follow-up time) was associated with significantly better survival compared with no RM (HR 2.10; P<0.001).

Even low adherence (defined as weekly maintenance records sent to the server <75% but more than 0% of their follow-up time) was associated with better survival than no RM (HR: 1.58; P < 0.001).

"Remarkably, only one-quarter of all patients receiving automatic RM-capable CIEDs in this nationwide analysis occupied the high [adherence] category, indicating that the vast majority of recipients do not utilize the full capabilities of their implantable devices," concluded the authors.

"Clearly it is underutilized," commented , from the Medical University of South Carolina in Charleston, who was not involved in the research.

"There were early concerns of medico-legal issues but ... I think most physicians you talk to, their impression is that the single biggest reason patients are not remote monitored is that many systems are not compatible with cell phone use, and we're finding more and more of our patients who only have cell phones, so unless they have a land line they can't use remote monitoring."

Reimbursement has also lagged, added , from the Royal Melbourne Hospital, in Melbourne, Australia. "This kind of data can convince providers that they need to pay."

Commenting on the JACC article, in an accompanying editorial, and , of the Yale School of Medicine, and Keck School of Medicine of USC, University of Southern California Los Angeles, wrote "research must be conducted to better understand patient- and physician-level impediments to adopting RM and methods to address these barriers"... and "the cardiac implantable device and research communities should continue to investigate ways of optimizing and improving RM."

Cardiac implantable devices "are in the vanguard of the personal 'big data' revolution," they concluded. "It is imperative that we continue to improve the quality and use of the data they generate to best meet the needs and optimize the outcomes of patients and enable physicians to practice most efficiently."

Disclosures

Piccini disclosed relevant relationships with Medtronic and Boston Scientific.

His co-authors disclosed the following relationships: S. Mittal: St. Jude Medical, Boston Scientific, Medtronic; J.D. Snell: St. Jude Medical; N. Dalal: St. Jude Medical; N. Varma: St. Jude Medical.

Kalman has disclosed relationships with Biotronik, Medtronic, St Jude Medical, Biosense Webster, and Boston Scientific.

Gold is a consultant to and receives clinical trials funds from Medtronic, Boston Scientific, and St. Jude Medical.

Freeman receives research grants from the National Heart, Lung and Blood Institute and consulting fees from Janssen Scientific.

Saxon disclosed relevant financial relationships with St. Jude Medical and Medtronic.

Primary Source

Heart Rhythm Society

Source Reference: Piccini JP, et al "Impact of remote monitoring on clinical events and healthcare utilization: a nationwide assessment" HRS 2015; Abstract LBCT-01-01.