Circulation: Automatic patient monitoring can reduce 45% of in-office visits
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| CardioMessenger II-S Patient Device for home monitoring. Image Source: Biotronik |
While the authors wrote that ICDs improve survival, “clinical practice is inconsistent and post implantation follow-up is necessary to monitor a patient’s device and condition. However, the authors wrote that “increased frequency of evaluation of a large patient population with a low incidence of problems challenges both patient compliance and clinic follow-up capacity.”
To assess the ability to follow patients with ICDs post implantation, Niraj Varma, MA, of the Cleveland Clinic, and colleagues randomized 1,450 patients at a 2:1 ratio to home monitoring (977 patients) or conventional follow-up (473 patients) during the TRUST (Lumos-T Safely Reduces Routine Office Device Follow-up) trial.
The trial, conducted between August 2005 and February 2008, followed patients at 102 U.S. sites at three, six, nine, 12 and 15 months subsequent to ICD implantation.
A total of 908 home monitoring and 431 conventional arm patients reached the one-year follow-up mark. One hundred and eleven patients exited the study prior to its end--40.5 percent of these patients withdrew, 18.9 percent died, 7.2 percent experienced home monitoring transmission failure and 35.1 percent were loss to follow-up.
During the study, 3.4 percent of the home monitoring patients died compared to 4.9 percent of the conventional care patients.
The results showed the mean number of in-clinic and hospital visits to be 2.1 per patient-year in the home monitoring arm and 3.8 per patient-year in the conventional care arm—an in-office visit reduction of 45 percent in the home monitoring arm at 12 months.
Additionally, Varma and colleagues found that three months post ICD implantation in-clinic device visits were reduced by 60.6 percent and 85.8 percent of the follow-up visits for patients in the home monitoring arm at six, nine and 12 months were performed using home monitoring only. The authors wrote that these numbers indicate “that home monitoring provided sufficient assessment in these cases.”
Adverse event rates were the same in both study arms (10.4 percent) indicating that safety was similar for both methods of follow-up.
The authors noted that patient follow-up after ICD implantation is “onerous” due to challenges such as patient volume and prompt problem detection, but three- and six-month follow-ups are necessary for patient safety and device monitoring to prevent adverse events.
“The TRUST trial demonstrated that automatic home monitoring ensured continuity of follow-up of a large patient volume, avoided unnecessary in-hospital patient evaluation (thus reducing clinic load), but maintained continuous surveillance to rapidly identify patients requiring attention,” the authors concluded.“The trial results have significant implications for the management of all patients receiving implantable electronic cardiac devices.”
The trial was funded by Biotronik.