We examined the utility of quality indicators (QIs) for transcatheter aortic valve implantation (TAVI) in the assessment of TAVI care quality and variation in practice.

We performed a retrospective population-level cohort study in Ontario, Canada, where all residents receive publicly funded universal medical care. We examined the association between QI attainment and outcomes using multivariable hierarchical logistic models. We used median ORs to understand if variation in clinical outcomes between hospitals was attributable to variation in QI attainment.

We used all-comer registry data from the provincial CorHealth registry in Ontario, with linkage to administrative datasets using unique patient encoded identifiers.

TAVI recipients between 2018 and 2023 in Ontario, Canada.

We derived a unique set of QIs from internationally agreed ones.

The primary endpoint was a composite of all-cause mortality or rehospitalisation at 1 year from the date of TAVI.

Data from 9748 TAVI procedures were included between 2018 and 2023. We identified five feasible QIs, the majority of which had high compliance and minimal variation; the lone exception was the performance of transfemoral TAVI without general anaesthesia (median 0.87; IQR 0.78–0.93). Adherence to QIs was associated with a reduction in the composite endpoint. The strongest association was observed with multidisciplinary heart team involvement (defined as the presence of an interventional cardiologist and a cardiac surgeon) in the TAVI procedure (OR 0.67, 95% CI 0.50 to 0.90, p=0.007), the performance of transfemoral TAVI without general anaesthesia (OR 0.80, 95% CI 0.71 to 0.91, p<0.0004) and the utilisation of the transfemoral access (OR 0.84, 95% CI 0.69 to 1.04, p=0.10). However, variation in clinical outcomes following TAVI between hospitals was not attributable to variation in QI attainment. Falsification analysis suggests substantial residual confounding.

We developed a feasible set of QIs for TAVI and validated these QIs using routinely collected data from a large all-comer registry in Ontario. We have identified overall high quality of care for TAVI, but with some variation in practice, which in part is attributable to differences in patient factors. Our work suggests that QIs can inform quality improvement efforts by prompting future work into discretionary versus non-discretionary variation.

Percutaneous coronary intervention (PCI) has evolved significantly over the past decade with approximately 30% of patients presenting with complex coronary artery disease, posing heightened procedural and long-term risks. Complexity in PCI is increasingly recognised as multifactorial, encompassing lesion, procedural and patient-related characteristics. The Ultimaster Nagomi sirolimus-eluting coronary stent system is designed to address the challenges of complex PCI. The NAGOMI COMPLEX study aims to assess its safety and clinical performance in a comprehensively defined complex PCI population, reflecting routine clinical practice.

This is a prospective, multicentre, single-arm cohort study enrolling 3000 subjects undergoing complex PCI across 52 European sites. Eligible patients must meet at least one complex PCI criterion, such as multivessel PCI, bifurcation lesions, chronic total occlusions or long total stent length implantation (>60 mm). Patients will undergo PCI using the Ultimaster Nagomi sirolimus-eluting coronary stent system, with follow-up assessments conducted at 30 days, 6 months, 1 year and 2 years. The primary endpoint is Target Lesion Failure at 1 year, defined as a composite of cardiovascular death, target-vessel myocardial infarction and clinically driven target lesion revascularisation. Secondary endpoints include device success, lesion success, procedure success, rates of stent thrombosis, bleeding complications (Bleeding Academic Research Consortium (BARC 3–5)), patient-reported outcomes (EQ-5D-5L, Seattle Angina Questionnaire (SAQ-7)) and resource utilisation for health-economic analysis. Subgroup analyses will explore outcomes across clinical and procedural complexity criteria. Clinical events will be adjudicated by an independent Clinical Events Committee, while a Data Monitoring Committee will oversee safety.

The study complies with the Declaration of Helsinki, EU MDR 2017/745, ISO 14155:2020, EU Regulation 2016/679 (General Data Protection Regulation), GCP and applicable national regulations. Ethics Committee approval has been obtained at all participating sites. Written informed consent is required from all subjects. Results will be disseminated through peer-reviewed publications and scientific conferences.

NCT05705973.