Background Despite the availability of guidelines for the performance of transcatheter aortic valve implantation (TAVI), current treatment pathways vary between countries and institutions, which... Show moreBackground Despite the availability of guidelines for the performance of transcatheter aortic valve implantation (TAVI), current treatment pathways vary between countries and institutions, which impact on the mean duration of postprocedure hospitalization.Methods and Results This was a prospective, multicenter registry of 502 patients to validate the appropriateness of discharge timing after transfemoral TAVI, using prespecified risk criteria from FAST-TAVI (Feasibility and Safety of Early Discharge After Transfemoral [TF] Transcatheter Aortic Valve Implantation), based on hospital events within 1-year after discharge. The end point-a composite of all-cause mortality, vascular access-related complications, permanent pacemaker implantation, stroke, cardiac rehospitalization, kidney failure, and major bleeding-was reached in 27.0% of patients (95% CI, 23.3-31.2) within 1 year after intervention; 7.5% (95% CI, 5.5-10.2) had in-hospital complications before discharge and 19.6% (95% CI, 16.3-23.4) within 1 year after discharge. Overall mortality within 1 year after discharge was 7.3% and rates of cardiac rehospitalization 13.5%, permanent pacemaker implantation 4.2%, any stroke 1.8%, vascular-access-related complications 0.7%, life-threatening bleeding 0.7%, and kidney failure 0.4%. Composite events within 1 year after discharge were observed in 18.8% and 24.3% of patients with low risk of complications/early (<= 3 days) discharge and high risk and discharged late (>3 days) (concordant discharge), respectively. Event rate in patients with discordant discharge was 14.3% with low risk but discharged late and increased to 50.0% in patients with high risk but discharged in <= 3 days.Conclusions The FAST-TAVI risk assessment provides a tool for appropriate, risk-based discharge that was validated with the 1-year event rate after transfemoral TAVI.Registration URL: https://www.ClinicalTrials.gov; Unique identifier: NCT02404467. Show less
Barbanti, M.; Mourik, M.S. van; Spence, M.S.; Iacovelli, F.; Martinelli, G.L.; Muir, D.F.; ... ; Tamburino, C. 2019
Aims: Treatment pathway optimisation in TAVI should include timely patient discharge with a minimised risk for out-of-hospital adverse events. The aim of this study was to define a standardised set... Show moreAims: Treatment pathway optimisation in TAVI should include timely patient discharge with a minimised risk for out-of-hospital adverse events. The aim of this study was to define a standardised set of risk criteria that allows a safe and timely discharge, to validate their appropriateness prospectively in different centres and multiple European countries, and to assess post-discharge outcomes.Methods and results: We defined and validated the adequacy of a set of discharge criteria and its ability to predict timely and safe discharge properly after the intervention in a prospective, European, multi centre registry. A total of 502 unselected patients were enrolled at 10 sites in three countries. The primary endpoint, defined as a composite of all-cause mortality, vascular access-related complications, permanent pacemaker implantation, stroke, re-hospitalisation due to cardiac reasons, kidney failure and major bleeding at 30 days, was reached in 12.9% of patients (95% CI: 11.3-16.5). The overall 30-day mortality was 1.1% (95% CI: 0.2-2.0), and the rates of stroke/TIA 1.7% (95% CI: -0.6 to 4.0), PPI 7.3% (95% CI: 5.8-8.9), major vascular complications 1.9% (95% CI: 0.7-3.1), major/life-threatening bleeding 2.4% (95% CI: 1.0-3.8) and cardiac re-hospitalisation 3.7% (95% CI: 1.4-6.0). Patients appropriately discharged early had a significantly lower risk of the primary endpoint (7.0 vs. 26.4%; p<0.001) which was reflected in some of its relevant components: stroke (0.0 vs. 2.8%; p=0.015), PPI (4.3 vs. 15.9%; p<0.001), major vascular complications (0.3 vs. 4.7%; p=0.004) and major/life-threatening bleeding (0.3 vs. 6.5%; p<0.001).Conclusions: We validated the appropriateness of a pre-specified set of risk criteria that allows a safe and timely discharge. The lute of 30-day complications did not reveal any risk increase with this strategy compared with the reported outcomes in major TAVI trials and registries. Show less
Barbanti, M.; Baan, J.; Spence, M.S.; Iacovelli, F.; Martinelli, G.L.; Saia, F.; ... ; Tamburino, C. 2017
