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Remote ICD implantation follow-up comparable to office-based follow-up
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European Society of Cardiology Congress 2011
Remote follow-up to implantable cardioverter defibrillator implantation yielded noninferior results to standard in-office 3-month follow-up for a composite endpoint, according to new results.
However, the findings, which were presented at the European Society of Cardiology Congress 2011 in Paris, also indicated overall noninferiority due to the event rate difference between the two groups.
The trial was conducted to determine whether remote follow-up to ICD implantation is a safe, efficient and cost-effective alternative to the standard 3-month follow-up for the procedure.
The trial was conducted in 1,501 patients from 30 centers in France between January 2008 and January 2010. Eligible participants were followed up every 3 months for 1 year. Half of the patients were followed up every 3 months at the implant center, and the other half were followed remotely, according to the results.
Philippe Mabo, MD, of the University Hospital of Rennes, France, said the primary endpoints of the study included all-cause clinical composite of death, CV hospitalization and ineffective or inappropriate therapy delivered by the device.
The primary endpoint was validated in 28.5% of 749 patients in the control group and 30.2% of 748 patients in the remote follow-up group, which Mabo said was within the noninferiority margin of 5%.
No statistically significant differences were observed between the two groups regarding time to occurrence of first primary endpoint (P=.71) and the 1-year survival rate (P=.31), according to Mabo.
Patients in the control group had more inappropriate therapies than those in the remote follow-up group, 7.5% vs. 4.7% (P=.03).
Despite these results, the noninferiority hypothesis — which was defined as a strict noninferiority margin of 5% — was not confirmed because the event rate difference between the two groups was 1.7% (95% CI, –0.3 to 6.4).
Forty-six patients switched from the remote to the control group before completion of the trial.
“The remote follow-up of patients implanted with an ICD seems to be a safe alternative to conventional in-office follow-up,” Mabo said. “However, for the widespread uptake of this new strategy — at least in France — reimbursement from the health care system will be needed. We hope that it will be available soon in France.”
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Disclosure: Dr. Mabo reported no relevant financial disclosures.
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