Abstract
IntroductionDespite considerable advances in the last decade, major adverse events remain a concern after transcatheter aortic valve implantation (TAVI). The aim of this study was to provide a detailed overview of their underlying causes and contributing factors in order to identify key domains for quality improvement.MethodsThis observational, prospective registry included all patients undergoing TAVI between 31 December 2015 and 1 January 2020 at the St. Antonius Hospital in Nieuwegein and the University Medical Centre in Utrecht. Outcomes of interest were all-cause mortality, stroke, major bleeding, life-threatening or disabling bleeding, major vascular complications, myocardial infarction, severe acute kidney injury and conduction disturbances requiring permanent pacemaker implantation within 30 days after TAVI, according to the Valve Academic Research Consortium‑2 criteria.ResultsOf the 1250 patients who underwent TAVI in the evaluated period, 146 (11.7%) developed a major complication. In 54 (4.3%) patients a thromboembolic event occurred, leading to stroke in 36 (2.9%), myocardial infarction in 13 (1.0%) and lower limb ischaemia in 11 (0.9%). Major bleeding occurred in 65 (5.2%) patients, most frequently consisting of acute cardiac tamponade (n = 25; 2.0%) and major access-site bleeding (n = 21; 1.7%). Most complications occurred within 1 day of the procedure. Within 30 days a total of 54 (4.3%) patients died, the cause being directly TAVI-related in 30 (2.4%). Of the patients who died from causes that were not directly TAVI-related, 14 (1.1%) had multiple hospital-acquired complications.ConclusionA variety of underlying mechanisms and causes form a wide spectrum of major threats affecting early safety in 11.7% of patients undergoing TAVI in a contemporary cohort of real-world patients.Supplementary InformationThe online version of this article (10.1007/s12471-021-01638-8) contains supplementary material, which is available to authorized users.
Highlights
Despite considerable advances in the last decade, major adverse events remain a concern after transcatheter aortic valve implantation (TAVI)
We provide a detailed overview of the underlying causes and impact of major complications following transcatheter aortic valve implantation (TAVI), based on a contemporary cohort of realworld patients
Patients who developed a major complication more frequently had a history of peripheral artery disease (p = 0.015) and pulmonary hypertension (p = 0.035), compared with patients not suffering a major complication. They were in a higher New York Heart Association class (p = 0.006), had worse left ventricular ejection fraction (p = 0.026) and mitral regurgitation (p = 0.020), and a higher Edmonton Frail Scale (EFS) score (p = 0.005)
Summary
Despite considerable advances in the last decade, major adverse events remain a concern after transcatheter aortic valve implantation (TAVI), as they significantly limit quality of life in the affected patients [1,2,3]. This is the case, since improvement of quality of life is considered highly important in this fragile, elderly population, with the highest mean age of all cardiac interventions [4, 5]. The aim of the present study was to provide a contemporary, indepth overview of the underlying causes and impact of major complications following TAVI, based on the detailed institutional registries and additional analyses of affected individual cases, in two high-volume centres in the Netherlands
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