A MULTIDISCIPLINARY, MULTIMODALITY, BUT MINIMALIST (3M) APPROACH TO TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT FACILITATES SAFE NEXT DAY DISCHARGE HOME IN HIGH RISK PATIENTS: 1 YEAR FOLLOW UP

Abstract

Transcatheter aortic valve replacement (TAVR) is an alternative to surgery in high risk operable patients; however, complications and cost currently limit expansion into lower risk populations. Although mortality, morbidity and length of stay (LOS) are expected to improve, we sought to determine if a multidisciplinary, multimodality, but minimalist (3M) approach could improve outcomes with currently available valve technology. Patients considered high risk for surgery, but relatively low risk for TAVR, were rigorously screened with functional and cognitive assessments as well as multi-modality imaging. From a potential pool of 335 accepted transfemoral TAVR patients between August 2011 and March 2014, 73 (22%) were selected and underwent SAPIEN XT (Edwards Lifesciences Inc., CA, USA) valve implantation utilizing percutaneous arterial access and area-based computed tomography sizing. All procedures in the second half of the cohort (38/73) were performed awake with no sedation and only femoral monitoring. Thirty day and one year outcomes were reported according to VARC-2 guidelines. The mean patient age was 83±7 years with a mean STS score of 8.3±3.7%. All-cause mortality or major stroke at 30 days and 1 year was 1.4% (1/73) and 8% (4/50) respectively. Procedural events at 30 days included life-threatening bleeding (1.4%), major vascular complications (2.7%), and need for permanent pacemaker (2.7%). The median LOS was 1 day (IQR1-2) with a mean LOS of 1.7±1.5 days. The mean LOS for the initial intubated cohort (35/73) vs the awake cohort (38/73) was 2.1±2 vs 1.3±1 days respectively (p=0.03). Overall, 50/73 (68%) were discharged home one day post TAVR with 2 readmissions (2.7%) within 30 days. Aortic valve area increased from 0.7±0.14 cm2 to 1.69±0.29 cm2 (p<0.001) at 30 days and 1.5±0.25cm2 (p<0.001) at 1 year; mean trans-aortic gradient decreased from 43±18 mmHg to 9 ± 3 mmHg (p < 0.001) at 30 days and 11±5 mmHg (p < 0.001) at 1 year. At 30 days and 1 year, 98% (71/73) and 92% (46/50) were NYHA class I or II with mild or less paravalvular regurgitation. Rigorous patient screening as well as improvements in procedural guidance, device selection, and adherence to the 3M clinical pathway permits safe next day discharge home in high risk patients with a 92% survival rate at 1 year. The 3M approach may facilitate significant cost savings and thus allow TAVR to be delivered to a broader range of lower risk patients.