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Transvenous pacemaker complications present in 1 in 6 patients by 3 years
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Complications related to transvenous pacemakers have become more common and contribute to the national health care cost, according to an analysis published in JACC: Clinical Electrophysiology.
“Pacemaker complications in the real world aren’t exactly as measured in clinical trials, which are usually done in academic and other tertiary medical centers,” Daniel J. Cantillon, MD, medical director for the central monitoring unit and research director for the section of cardiac electrophysiology and pacing at Cleveland Clinic, told Cardiology Today. “Many centers do not voluntarily report them — as we do — but it turns out they rarely fail to bill for services rendered in managing them. This was captured by our study’s use of claims data, and the costs are staggering.”
Cantillon, a Cardiology Today Next Gen Innovator, and colleagues reviewed data from 72,701 patients (mean age, 75 years; 55% men) who had a single- or dual-chamber pacemaker implanted between April 2010 and March 2014 and were covered by private or Medicare supplemental insurance. The majority of patients (n = 63,325) had a dual-chamber pacemaker.
Pacemaker-related complications were classified as acute, which occurred within 1 month after implant, or long-term, which occurred beyond 1 month. Patients were followed up for a mean of 1.5 years.
Acute complications occurred in 7.7% of patients with single-chamber pacemakers and 9.1% of patients with dual-chamber pacemakers. The most common acute complications were thoracic trauma (3.71%; incremental cost, $70,114), leads that required revision (3.51%; $9,296) and infection (1.15%; $80,247).
Long-term complications occurred in 6.4% of patients in the single-chamber group and 5.9% of patients in the double-chamber group, which included revised leads (2.84%), infection (2.42%) and pocket-related complications (0.96%).
“The overwhelming majority of pacemaker complications captured in our study are related to the pacemaker lead (wire) and the surgical pocket in the chest created to enclose the unit,” Cantillon said. “Leadless cardiac pacemakers have neither of these, and thus carry the potential to greatly reduce complication rates over the long-term.”
Within 3 years, a pacemaker-related complication occurred in 15% of patients with a single-chamber pacemaker and 16% of those with a dual-chamber pacemaker.
“Common ‘lead complications’ resulted in adjusted incremental costs of $9,193 ± 3,842 and $8,596 ± 2,903 for commercial and Medicare Supplemental insurance patients, respectively. … The cost associated with the most common complication of lead dislodgement is similar to the cost of a de novo implant. Uncommon but serious complications, such as pericardial effusion, carry costs that are similar to four to five de novo implants. The incremental costs associated with pacemaker-related complications in Medicare patients are higher than those reported in a hospital-based analysis performed on ICD patients with Medicare insurance in 2006,” the researchers wrote.
“One cannot help but wonder if real-world complication rates are also higher for other surgical procedures than has been reported in clinical trials,” Cantillon told Cardiology Today. “For pacemakers specifically, what is needed is a comparative long-term study of leadless cardiac pacemakers and traditional transvenous pacemakers to determine if this new technology can eliminate lead-related and pocket-related complications over the long term.” – by Darlene Dobkowski
Disclosures: Cantillon reports he is a consultant for Abbott, Boston Scientific, St. Jude Medical and Stryker Medical and receives research support from Abbott, LifeWatch and Stryker Medical. Please see the study for all other authors’ relevant financial disclosures.
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