CIEDs of Doubt: Pacemaker, ICD Complication Rates Seem High, Vary Widely by Hospital

Liam Davenport

July 31, 2019

The rate of major complications associated with cardiac implantable electronic-device (CIED) implantation varied widely among different centers in recent data from Australia and New Zealand.

The rate averaged about 8% for permanent pacemakers and implantable cardioverter defibrillator (ICD) procedures across all evaluated centers in the two countries, but exceeded 15% for ICD procedures at some institutions.

"Collectively, our findings imply substantial institutional heterogeneity in the quality of CIED care and suggest that targeted clinical and policy interventions are needed to address CIED-related complications," conclude the authors of the analysis published July 30 in the Annals of Internal Medicine.

Such efforts should focus especially on pacemakers, "because three-quarters of all CIED complications were attributable to these devices," they write.

"Pacemakers and ICDs are not new devices. It is remarkable to have such high complication rates for a common procedure," observed lead author Isuru Ranasinghe, MBChB, PhD, Basil Hetzel Institute for Translational Research, University of Adelaide, Australia.

"This highlights how little we have invested in improving the safety of CIEDs and the barriers to implementing change. We clearly need to develop better systems to make these procedures safer," Ranasinghe told | Medscape Cardiology .

He and his colleagues reviewed data from more than 80,000 patients who were implanted with either a pacemaker or ICD as their first such device from 2010 to 2015 at 174 hospitals in the two countries.

Although 8.2% of patients who received CIEDs across all centers experienced a major complication in hospital or within 90 days of discharge, rates for pacemaker implantation ranged by center from about 5% to 13%, whereas those related to ICD placement ranged from about 10% to 17%.

It was higher for ICDs than for pacemakers, but the far larger number of pacemakers implanted — four times as many as ICDs — meant that the they accounted for 76.5% of the complications, the report notes.

Major complications could include death, device-related reoperation, shock, endocarditis, or rehospitalization for a device- or lead-related infection.

An analysis of risk-standardized complication rates (RSCR) among the 98 hospitals that had implanted at least at least 25 CIEDs over the study period saw wide variations between institutions.

The findings "have implications for policy efforts to reduce complications and standardize care" and "lend weight to implementing facility-level measures of CIED complications" that would be suitable for public reporting, the authors write.

"Such a policy change may help make these complications fully transparent and, over time, minimize variation in outcomes among institutions."

Ranasinghe proposed that routine reporting of complications is necessary because about 60% of complications occur after the patient has left the hospital. "Many doctors and hospitals may not be fully aware of the complications experienced by patients without such reporting systems."

The complications highlighted in the study are "are not trivial; they may have a profound effect on patients' well-being and quality and duration of life," notes an accompanying editorial.

"Nonetheless, the risks associated with CIED implantation remain generally underappreciated," write Jorge A. Wong, MD, MPH, and P.J. Devereaux, MD, PhD, McMaster University, Hamilton, Ontario, Canada.

They point out that patients receiving CIEDs are often older, frail, and with serious comorbidities. So the current findings "are important for clinical decision making and crucial in facilitating the informed consent process between patients and their physicians."

Recent analysis of data from the US National Cardiovascular Data Registry (NCDR) showed variations in ICD complication rates across participating hospitals, which led to calls for quality measures.

But it's unclear, the authors note, whether such variations occur in other populations and health systems, and there is no systematic data on complication rates with pacemakers alone, even though they are more frequently implanted.

Their analysis included all adults who received a pacemaker or ICD as an emergency or planned procedure, excluding CIED replacements and patients who underwent catheter ablation or cardiac surgery during the same hospitalization, who were followed for at least 90 days.

Between 2010 and 2015, 81,304 patients received a CIED at 174 hospitals; 80.8% were pacemaker implantations and 19.2% involved an ICD. Their mean age was 74.7 years and 34% were women. The median length of stay was 3 days, and about 40% of procedures were carried out as emergencies.

A major device-related complication was recorded in 8.2% of cases. Although the rate was higher for ICDs than for pacemakers (10.04% vs 7.76%), 76.5% of the complications were related to pacemakers.

The complications were in-hospital for 3.33% of the total cohort, with little difference between pacemakers and ICDs, and included lead reoperation, pneumothorax, hemothorax, pleural effusion requiring drainage, and death.

At least one postdischarge complication was recorded in 5.12% of patients, the most common of which was rehospitalization for a complication, at 3.45%.

ICD patients were more likely to experience a postdischarge complication than pacemaker patients (7.21% vs 4.63%), largely because of higher rates of reoperation and readmission for complications, the authors note.

In the derivation cohort for development of the RSCR, they report, an urgent implantation, female sex, ICD as the device, device capable of cardiac resynchronization therapy (CRT), and a range of comorbidities were associated with an increased complication risk.

At the top of that comorbidity list were a history of cardiac infection or inflammation, major or metastatic cancer, and end-stage liver disease, "although individually these disorders were uncommon," the group writes.

The median RSCR among hospitals implanting at least 25 devices over the study period was 8.1% (range, 5.3% to 14.3%). The results were similar when the researchers restricted their analysis to 88 hospitals that had performed at least 25 elective CIED implantations (median, 7.4%; range, 4.7% to 13.0%).

Although similar complication rates were seen in the US-based NCDR analysis, its population was limited to Medicare patients, who are by definition 65 years and older and arguably sicker, the researchers note.

"We extend the literature by showing that institutional variation occurs regardless of age or payer," they write.

"Moreover, our demonstration of institutional heterogeneity in different health systems suggests that such variation results primarily from hospitals' CIED procedural quality and after-care practices, rather than broader health-system factors such as health care infrastructure, resourcing, and funding models."

In the editorial, Wong and Devereaux note that the study has "several strengths," not least of which are its size and the timeliness of the data. It's also the first to report differences in pacemaker-implantation quality among institutions, and to emphasize efforts to improve quality of pacemaker-related care at the institutional level, they write.

Still, they observe, the analysis is limited by its retrospective nature, with all its potential for confounding. And reliance on diagnostic codes "often leads to underreporting of secondary diagnoses and complications" and may have omitted "relevant and important clinical details."

Moreover, the inclusion of hospitals that have implanted 25 or more CIEDs over 5 years in the RSCR analysis means that yearly volumes could have been as few as five.

"Previous studies suggest that operators implanting fewer than 50 CIEDs per year have double the risk for complications," they write. "Including very low-volume centers in this analysis thus may have exaggerated the institutional variability in CIED complications."

Whereas there is a learning curve with every procedure, Ranasinghe pointed out, the inclusion of some hospitals that had performed a small number of procedures will not have substantially altered the findings.

"I don't think this fully explains the variability that we observed," he said.

"Small-volume hospitals tend to have wide confidence intervals around their estimated complication rate that often cross the national average," and "several of the hospitals that had higher than average complication rates were moderate to large-volume facilities."

Ranasinghe added: "We certainly should not assume that large-volume facilities will have a lower complication rate, and vice versa."

Ranasinghe discloses receiving grants from the HCF Research Foundation of Australia, the National Heart Foundation of Australia, and the Hospital Research Foundation during the conduct of the study; disclosures for the other authors are in the report. Devereaux discloses receiving grants from Abbott Diagnostics, Boehringer Ingelheim, Philips Healthcare, Roche Diagnostics, and Siemens outside the submitted work. Wong declared no conflicts.

Ann Intern Med. Published online July 30, 2019. Abstract, Editorial

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