Major threats to early safety after transcatheter aortic valve implantation in a contemporary cohort of real-world patients

Abstract

Introduction Despite 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. Methods This 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. Results Of 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. Conclusion A 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.

Evolving concepts in the management of antithrombotic therapy in patients undergoing transcatheter aortic valve implantation

“…The incidence of thromboembolic events varies between 3 and 15% within the first year following TAVI, depending on the risk level of the treated population [3][4][5][6][7][8][9][10][11][12][13][14][15][16]. This involves the occurrence of ischaemic stroke and transient ischaemic attack (~1-7%), myocardial infarction (~0.5-2%), systemic thromboembolism (~0.5-2%), intra-cardiac thrombus (0.5-1%) and obstructive valve thrombosis (~0.5-3%) [3][4][5][6][7][8][9][10][11][12][13][14]. These complications have devastating effects, especially ischaemic stroke, leading to permanent disability or death in many of the affected patients [7,11].…”

“…This involves the occurrence of ischaemic stroke and transient ischaemic attack (~1-7%), myocardial infarction (~0.5-2%), systemic thromboembolism (~0.5-2%), intra-cardiac thrombus (0.5-1%) and obstructive valve thrombosis (~0.5-3%) [3][4][5][6][7][8][9][10][11][12][13][14]. These complications have devastating effects, especially ischaemic stroke, leading to permanent disability or death in many of the affected patients [7,11]. Most of the thromboembolic events occur within the first 48 hours, followed by an ongoing increased incidence in the first months with a gradual decrease thereafter [3][4][5][6][11][12][13][14]16].…”

“…In the elderly, the CHA2DS2-VASc score may help to quantify thromboembolic risk and give an indication of frailty status [24]. Also, specific frailty assessment tools, like the Edmonton Frail Scale, may identify individuals at highest risk of a poor outcome [7,24,25].…”

“…The incidence of major bleeding varies between 3 and 17% in the first year after TAVI and consists of periprocedural (mainly vascular access related) bleeding and spontaneous bleeding [3][4][5][6][7][8][9][10][12][13][14]26,27]. Most spontaneous bleeding events occur in the gastro-intestinal or urogenital tract [9,10].…”

“…Although TAVI techniques and the risk level of the treated population have improved over time, thromboembolic and bleeding complications are still frequent and negatively impact recovery and survival after TAVI. [7] To prevent thromboembolic, in particular cerebrovascular events, antithrombotic therapy is recommended in all TAVI patients. [1,2] However, recent evidence underlines to be cautious with intensive antithrombotic treatment, given the associated risk of bleeding in the current TAVI population [8][9][10].…”