Minimalistic Approach for Transcatheter Aortic Valve Implantation (TAVI): Open Vascular Vs. Fully Percutaneous Approach.

Abstract

Aortic stenosis (AS) is the most common valvular heart disease in elderly people. Transcatheter aortic valve implantation (TAVI) has emerged as a revolutionary treatment for elderly patients with symptomatic severe aortic stenosis. The authors present the first experiences with transcatheter aortic valve implantation treatment in Macedonia and compare their findings in regard to differences between open vascular vs. minimalistic transfemoral TAVI approach. The procedure was performed in 54 patients with severe and symptomatic AS in the period from December 2014 until February 2018. All patients were deemed having high surgical risk or were denied surgery. Pre-procedural screening included detailed clinical and echocardiographic evaluation, coronary, peripheral and carotid angiography and computed tomography scan of the aortic root. A self-expandable aortic valve (Core Valve/Evolut R, Medtronic, USA) was implanted in all patients. Mean patient age was 75 ± 7.2 years, 28 (52%) were female, 26 patients (48%) male. All interventions were successfully performed through right transfemoral approach with 100% implantation success. Ancillary right radial and ulnar approach was used for correct valve positioning and control. 22(40%) cases were performed under general anesthesia and open vascular access to the femoral artery. All other 32(60%) cases were performed with minimalistic approach (local anaesthesia and analgosedation of the patients, access site was closed with closure devices). Patients in the minimalistic approach group were older, with more chronic conditions as anaemia, chronic kidney disease, poor mobility and peripheral vascular disease (p<0.0001). Also 4(12.5%) patients in the minimalistic group had bicuspid valve TAVI implantation (p<0.0001). Procedural time and contrast amount spent were shorter in this group with 97± 38 vs. 121± 38.3(p<0.0001) and 287± 122 vs. 330± 115 ml, while fluoroscopy time was similar in both groups. Immediate hemodynamic improvement was obtained in all patients. Echocardiographic peak gradient decreased from 85 ± 25 to 17 ± 8 mmHg (p < 0.001) and mean pressure gradient from 49 ± 26 to 8.3 ± 4.2 mmHg, (p < 0.001). Effective valve orifice area was 1.8±0.4 cm2 after intervention. None of the patients had significant aortic regurgitation after implantation. After intervention 7(12%) patients developed a permanent heart block and required implantation of a permanent pacemaker. There was a larger Hgb drop after intervention with open vs. minimalistic approach 1,9±0.9 vs. 0.7±0,2 g/dL (p<0.0001). 3 (13% vs.0%) patients from the open vascular access group had a major bleeding complication with 2 requiring transfusion after intervention (p<0.0001). Mortality was 5.5%, 2 with open-vascular and 1 with minimalistic approach. MACCE rate that included MI, Stroke, Major bleeding and Death rate, was recorded in 5(18%) patients with open vascular approach vs. 1(3.1%) in minimalistic approach (p<0.0001). Hospital discharge was 8.7±3.1 vs. 4±3.1 days respectively (p<0.0001). All TAVI patients with minimalistic approach were discharged the following day after intervention. All discharged patients had a good neurological condition, which was assessed based on the CPC-1 (Cerebra Performance Categories Scale). After median follow up of 26 months, the survival rate was 95% with clinical improvement in all patients. Percutaneous aortic valve implantation can be successfully conducted with high success rate and low rate of complications in patients with severe aortic stenosis. Using a less invasive approach with local anaesthesia and analgosedation is associated with shorter length of stay and a decrease in post-procedural complication rates and MACCE.