Cardiologists express concern over study complication data

Unlike the Ganesan study, published in Internal Medicine Journal, GenesisCare cardiologists have found marked variation in complication rates for cardiac device implantation. They emphasise the importance of collecting high-quality prospective data.

The recent article by Ganesan et al in the Internal Medicine Journal, reporting complication rates of cardiac implantable electronic devices, will stimulate much discussion within Australia and internationally. The paper concluded that public and private hospitals in New South Wales and Queensland have similar safety outcomes for pacemaker and defibrillator implant surgeries. We commend the authors in addressing a key concern in health care — that of potential variability in outcomes across different providers, institutions and health systems.

The Ganesan group, responsible for this article, recently published a similar paper looking at institutional variation in quality of cardiovascular implantable electronic device implantation. In this paper, the group demonstrated a marked variation (up to 300%) in complication rates at different institutions.

Concerns have previously been raised about the data collection methods used in these papers based on administrative data coding. The lack of clinical adjudication and the perverse reimbursement incentive to over-record complications are well established. Recently — in an Australian surgical setting — the administrative coding method has been shown to poorly predict clinical outcomes when compared with prospective, dedicated clinical outcomes data collection.

The marked variation in outcomes and the different models of data collection highlight the importance of prospective, high-quality data at the point of care. The GenesisCare device registry was established to provide this.

GenesisCare is Australia’s largest cardiology group and the single largest provider of cardiac device implantation in Australia. The GenesisCare cardiac implantable electronic devices registry (device registry) was established in 2016 and records the success and complication rates of all devices implanted by GenesisCare cardiologists in private hospitals around Australia. The results are presented nationally and internationally each year and, to date, complete audited data is available on 5583 patients with a completion rate in excess of 99%. Similar extensive, prospective registries are maintained for all percutaneous coronary intervention (PCI), echocardiography and heart failure clinic patients.

A concerning aspect of the Ganesan paper is the high rate of device complications: 8.0% in private hospitals and 9.6% in public hospitals, which compares very unfavourably with the GenesisCare rate of 2.8%. The GenesisCare patient cohort is comparable to the Ganesan article, with a mean age of 75.9 years, an acute implant rate of 27%, along with similar rates of prior cardiac history, comorbidities and the mix and type of device.

In the GenesisCare cohort the overall rate of complications at 90 days was 2.8%, almost 70% lower than the overall rate from the current article. GenesisCare patients had a 47–88% reduction in the individual listed complications compared with the cohort presented in the article. Similarly, the in-hospital mortality rate from the GenesisCare device registry was 0.13%, 71% lower than the 0.45% mortality in the Ganesan article.

Obtaining such high clinical performance takes active management. The GenesisCare constitution mandates a Clinical Leaders Forum, a body responsible for ensuring doctors meet procedural volumes as recommended by the Cardiac Society of Australia and New Zealand and reviews each cardiologist’s outcomes measures. The overall complication rate of 2.8% and the variation in individual implanter complication rates (1.4–4.7%) within GenesisCare is significantly lower than other published series.

One of the reasons patients seek private health insurance is that it permits more active patient input into who will be their treating doctor. This article by Ganesan and the conversation it generates reinforces the need for patients and referring doctors to understand the marked variation in complication rates for device implantation and make an informed decision to choose an implanter with a low complication rate.

Unfortunately, there is no mandated reporting of complication rates or procedural volume in Australia.

We strongly advocate for the mandated collection of high-quality prospective data in health care that is accessible to patients and referring doctors.

*David O’Donnell is the Cardiologist and Electrophysiologist Head of Clinical Leadership at GenesisCare, as well as Board Director at GenesisCare.
**Daniel Cehic is Cardiologist and Electrophysiologist Cardiology Chief Medical Officer at GenesisCare.

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