Ambulatory TAVR: Early Feasibility Experience During the COVID-19 Pandemic

An 86-year-old man with chronic obstructive pulmonary disease and a permanent pacemaker implanted 6 months earlier for aortic valve block was admitted for ambulatory TAVR. This elective transfemoral TAVR procedure was performed with the patient under local anaesthesia and optimized using a new virtual reality google system from Deepsen (Saint-Didier-au-Mont-d’or, France) which involves a hypnosis and cardiac coherence algorithm with a 360-cinema screen (Fig. 1A ). Only 1 mg of midazolam was given at the beginning of the procedure, with an anaesthesiologist providing close patient supervision throughout. During any painful steps of the procedure (punctures, valve deployment), specific analgesia was provided through the google system by sending additional visual and auditory signals.

Transfemoral vascular access was performed after locoregional block, using an echo-guided puncture technique and a percutaneous suture-based closure device. No central venous access was needed. A 5-French pigtail catheter was introduced via the left dorsal distal radial artery (Fig. 1A). Using a left ventricular Safari XS (Boston Scientific, Marlborough, MA) supportive guidewire, a 26-mm Edwards Sapien valve (Edwards Lifesciences Corp, Irvine, CA) was implanted without predilatation (Fig. 1B). Cardiac standstill was obtained with direct wire pacing at 160 beats per minute for 15 seconds, avoiding the need for temporary right ventricular access and potential complications. The procedure was uneventful. Right femoral closure was assessed using a selective right iliofemoral angiogram and confirmed complete hemostasis without complications. Total procedural time was 43 minutes with 160 mL of contrast media and 47 Gy/cm² of dose surface area. The patient was transferred to the post procedure care unit where he underwent iliofemoral Doppler imaging and transthoracic echocardiography, which revealed a mean gradient of 4 mm Hg, an aortic valve area of 1.9 cm², and no intra- or paravalvular leak. Telemetry was unremarkable and ambulation was possible and well tolerated 3 hours after the femoral closure. Because the patient met strict criteria for an ambulatory TAVR strategy including no cognitive impairment, adequate social and family support, a previous pacemaker placement, no postprocedural complication, and because he was previously planned and informed for such an approach, he was home-discharged 6 hours after the procedure. A nurse visited him on day 1 and day 7 for clinical follow-up and he was seen in the outpatient clinic 1 month later. No adverse events were noticed.

To date, 3 ambulatory TAVR cases have been performed in our institution without complications in the 30 days post procedure. Baseline characteristics of each patient are described in Supplemental Table S1.

This is, to our knowledge, the first report of a small case series of outpatient TAVR procedures. It is of particular interest in the current context of the COVID-19 pandemic, which has generated increased pressure on health care systems around the world. Ambulatory TAVR, in well selected patients and using a minimalist approach, could be a safe option to: (1) reduce the clinical consequences of wait times for TAVR (several studies have shown higher mortality among patients with severe symptomatic aortic stenosis with a delay in treatment); (2) minimize potential exposure to coronavirus in patients at particularly high risk for clinical deterioration; and (3) reduce the use of hospital resources that might be needed for COVID-19 patients.

In our institution, ambulatory TAVR is offered to patients with selected baseline characteristics, and procedural and postprocedural requirements as listed in Supplemental Table S2. Patients are selected only in situations of adequate social and family support. To avoid post procedural conduction disturbances, previous permanent pacemaker placement is mandatory.

Limitations include the small number of cases performed to date, and restrictive patient selection criteria. On the basis of the national French registry, approximately 15% of patients who undergo TAVR have had a permanent pacemaker placed. This is an important limitation for increased use of ambulatory TAVR procedures. Moreover, this ambulatory strategy could be associated with delayed complications such as vascular access bleeding, emphasizing the need for careful post procedural monitoring.

Outpatient TAVR procedures are feasible and safe but require careful patient selection and a minimalist procedural approach. Increased adoption of this strategy, particularly during the COVID-19 pandemic, could lead to improve bed-flow efficiency, minimize coronavirus exposure risks, and avoid delays in treatment of severe aortic stenosis. Further studies are needed to confirm these findings.

The authors have no funding sources to declare.

The authors have no conflicts of interest to disclose.