Registry data underscore the importance of adopting specific protocols and preventive measures to reduce the risk of cardiac implantable electronic device complications and improve their management.
There is a well-known increased risk of mortality associated with device infections and lead extraction, but less is known about the impact of minor complications on mortality. A complication was defined as any CIED-related adverse event requiring surgical revision after the implantation procedure, including nonseptic pocket erosion, pocket hematoma, lead dislodgement, lead failure, generator malfunction, cardiac tamponade, and pneumothorax, according to a study published ahead of print in JACC: Clinical Electrophysiology.
In six high-volume centers, all consecutive patients (n = 2,811) referred for de novo pacemaker (PM), implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy (CRT) device implantation were enrolled in the POINTED registry over a 3-year period and followed for almost 5 years. No patient was lost to follow-up.
When considered as a single group, complications requiring surgical intervention did not reduce survival from all-cause death, but they significantly increased cardiovascular death over long-term follow-up, Pietro Palmisano, MD, of Card. Giovanni Panico Hospital, Tricase, Italy, and colleagues, wrote.
Recently, a pair of large, prospective, randomized clinical trials – PADIT and WRAP-IT – effectively established a benchmark (at least in the context of clinical trials) of approximately 1% for the 12-month risk of a CIED infection. In the POINTED Registry, the annual incidence of all complications was 2.1%, including device infection (n = 49), other complications (n = 219), and patients without complications (n = 2,543).
Like previous observational data, the main determinant of poor survival in Palmisano and colleagues’ analysis was the time of onset of complications. Early complications (within the first 30 days) were associated with a 2.8-fold increase in all-cause mortality and a 1.7-fold increase in cardiovascular mortality, after adjustment for potential confounders. The association between late complications and mortality was “non-existent or, at most, trivial.”
Device infection, nonseptic pocket decubitus, and pocket hematoma were associated with higher risk of cardiovascular death, as was the occurrence of multiple device-related complications. The lower survival from cardiovascular death in patients with complications held true for every group, including type of device implanted.
Other multivariate predictors of cardiovascular death included age, diabetes, permanent atrial fibrillation, dialysis, and chronic obstructive pulmonary disease.
Compared to patients without complications, patients with complications were younger, more likely to be men, and had a lower left ventricular ejection fraction. The finding regarding higher risk among men varies from a recent analysis of 2.8 million hospitalizations for de novo CIED implantations by Mohamed O. Mohamed and colleagues, published in the January issue of the Canadian Journal of Cardiology. In that analysis, women were at an overall higher risk of procedure-related adverse events than were men, but women were not at increased risk of all-cause mortality (adjusted odds ratio: 1.17; 95% confidence interval: 1.16-1.19).
Since the turn of the century, the global incidence of CIED infections has been increasing out of proportion to the rate of device implantation, driven predominantly by the implantation of devices in patients of increasing complexity and medical comorbidities.
The POINTED Registry results underscore the importance of adopting specific protocols and measures to reduce the risk of CIED complications and improve their management, Palmisano and colleagues write.
PADIT; Prevention of Arrhythmia Device Infection Trial; POINTED: Impact on Patient Outcome and healthcare utilization of cardiac ImplaNTble Electronic Devices complications; WRAP-IT: Worldwide Randomized Antibiotic Envelope Infection Prevention Trial.
Palmisano P, Guerra F, Dell'Era G, et al. Impact on all-cause and cardiovascular mortality of cardiac implantable electronic device complications: results from the POINTED registry. JACC: Clinical Electrophysiology 2020 Jan. 29. DOI: 10.1016/j.jacep.2019.11.005 [Epub ahead of print] http://electrophysiology.onlinejacc.org/content/early/2020/01/22/j.jacep.2019.11.005
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Mohamed MO, Volgman AS, Contractor T, et al. Trends of Sex Differences in Outcomes of Cardiac Electronic Device Implantations in the United States. Can J Cardiol 2020;36:69-78. http://bit.ly/3829J0A