'Targeted clinical and policy interventions are needed to address CIED-related complications'
The quality gap between the best and the worst hospitals was particularly large for cardiovascular implantable electronic device (CIED) placement in Australia and New Zealand, researchers found.
Isuru Ranasinghe, MBChB, PhD, of the Basil Hetzel Institute in Woodville South, South Australia, and colleagues identified the following risk-standardized 90-day complication rates from administrative data spanning the years 2010 to 2015:
- Institutional CIED complication rate among centers performing at least 25 such procedures during the study period: median 8.1% , varying from 5.3% to 14.3% (22.4% of centers were statistical outliers)
- Permanent pacemaker (PPM) implantation complications among hospitals performing at least 25 of these: median 7.6%, varying from 5.4% to 12.9% (16.7% of centers were outliers)
- Implantable cardioverter-defibrillator (ICD) placement complications among hospitals performing at least 25: median 9.7%, ranging from 6.2% to 16.9% (5.9% of centers deemed outliers)
- Elective CIED implantation complications among hospitals performing at least 25: 7.4%, ranging from 4.7% to 13.0% (13.6% were outliers)
This variability persisted no matter how the researchers tried to account for operator experience. Overall, CIED complications occurred at a rate of 8.2% after adjusting for risk, the researchers reported in the Annals of Internal Medicine.
"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. These efforts should preferentially target PPMs, because three quarters of all CIED complications were attributable to these devices," Ranasinghe and colleagues said.
Procedural complications were more common with ICDs than pacemakers (10.04% vs 7.76%), but there were 4.2 permanent pacemakers implanted for every ICD.
Previously, institutional variation in ICD complications had been systematically evaluated only in the National Cardiovascular Data ICD Registry, the authors noted. "We extend the literature by showing that institutional variation occurs regardless of age or payer."
"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," they stated.
Ranasinghe's group used hospitalization data linked to death records for the study. They identified more than 81,000 adults (average age 74.7, 37.9% women) who received at least one new permanent pacemaker or ICD over the 6-year observation period.
There were 174 hospitals in Australia and New Zealand that performed these CIED implantations, over half of them implanting at least 25 such devices during this time.
Over a third of patients who had complications had such events in-hospital; these were most often lead reoperations, followed by effusions requiring drainage of the pleural or pericardial cavity.
Most people with complications had events occur post-discharge, most commonly rehospitalization for a complication (most likely a mechanical complication of the device or infection).
The investigators noted that their dataset was not granular enough for them to differentiate between single- versus dual-chamber devices, for example. Another limitation was the possibility of unmeasured confounding in their retrospective study.
Yet a sensitivity analysis revealed that "an unmeasured confounder would have to be 2.47 times more frequent in the outlier hospital compared with the national average and increase the risk for complications by 2.47 times to explain away the difference so that the hospital is no longer an outlier," they said.
To reduce complications and standardize care, a policy of tracking complications of both permanent pacemaker and ICD placements may be supported by these data, according to Ranasinghe's group, which added that hospitals have several opportunities to reduce complications, including:
- Use of prophylactic antibiotics and infection control
- Avoiding bridging anticoagulation to minimize hematoma formation
- Testing for lead fixation into the myocardium
- Using leadless pacemakersand subcutaneous ICDs
- Quality control measures such as checklists and care pathways
"The study results suggest that the risk for early CIED complications differs substantially among hospitals, highlighting the need for increased initiatives at the institutional level to improve quality of care for CIED recipients," agreed Jorge A. Wong, MD, MPH, and P.J. Devereaux, MD, PhD, of McMaster University in Hamilton, Ontario, in an accompanying editorial.
Though the inclusion of "very low-volume centers" in the study might have "exaggerated the institutional variability in CIED complications," such complications are not trivial and remain generally underappreciated, they continued.
Ranasinghe disclosed support from The Hospitals Contribution Fund, the National Heart Foundation of Australia, and The Hospital Research Foundation.
Wong disclosed no relevant relationships with industry. Devereaux disclosed support from Abbott Diagnostics, Boehringer Ingelheim, Philips Healthcare, Roche Diagnostics, and Siemens.
Annals of Internal Medicine
Source Reference: Ranasinghe I, et al "Institutional variation in quality of cardiovascular implantable electronic device implantation: a cohort study" Ann Intern Med 2019; DOI: 10.7326/M18-2810.
Annals of Internal Medicine
Source Reference: Wong JA and Devereaux PJ "Cardiac device implantation complications: a gap in the quality of care?" Ann Intern Med 2019; DOI: 10.7326/M19-1895.
Read the original article on Medpage Today: Disturbing Variability Down Under in Heart Device Procedure Quality