SAN FRANCISCO – Using the guidewire for rapid pacing of the left ventricle during transcatheter aortic valve implantation (TAVI) instead of the usual approach – right ventricular pacing through a lead snaked up the femoral vein – significantly reduced procedure duration, fluoroscopy time, and cost, without affecting efficacy or safety, in a 10-center randomized controlled trial in France.
Pacing using the 0.035-inch guidewire in the left ventricle eliminates “the need for a transvenous temporary pacing lead or additional venous access in most cases,”said investigators led by Benjamin Faurie, MD, an interventional cardiologist at the Cardiovascular Institute, Groupe Hospitalier Mutualiste, Grenoble, France. It simplifies TAVI “and should be considered as the default strategy for rapid ventricular pacing.”
“If risk factors for development of high-grade conduction disturbances are present, upfront RV [right ventricular] stimulation with a temporary pacing lead should be considered; otherwise LV [left ventricular] stimulation might be used.” LV stimulation in TAVI “is particularly attractive in patients with an indwelling permanent pacemaker to avoid the risk of pacemaker lead dislodgement with a temporary pacing lead,” they said.
“This technique may also be useful in transcatheter heart valve implantation in the mitral position and in transcatheter tricuspid valve interventions, where having a standard temporary pacing lead across the tricuspid valve may interfere with the procedure,” the investigators said.
Rapid ventricular pacing ensures cardiac standstill during TAVI, but the RV approach carries the risk of vascular complications and RV perforation. LV guidewire pacing, a technique borrowed from pediatric balloon aortic valvuloplasty, avoids the risks. The French study – dubbed Direct Left Ventricular Rapid Pacing Via the Valve Delivery Guide-wire in TAVI (EASY-TAVI) – is the first randomized trial to compare the technique with conventional RV stimulation, and it was published to coincide with a presentation at Transcatheter Cardiovascular Therapeutics annual meeting (JACC Cardiovasc Interv. 2019 Sep 14. doi: 10.1016/j.jcin.2019.09.029).
The patients were undergoing transfemoral TAVI with a Sapien 3 valve (Edwards Lifesciences); 151 were randomized to LV stimulation through the guidewire, and 152 to RV stimulation through a temporary pacing lead.
Both procedure duration (48.4 minutes vs. 55.6 minutes) and fluoroscopy time (13.48 minutes vs. 14.6 minutes) were significantly shorter in the LV group than in the RV group. The procedure was also less costly (€18,807 vs. €19,437) because of shorter catheterization lab time and materials savings.
There were no significant difference between LV and RV groups in rates of effective stimulation (84.9% vs. 87.1%, respectively), procedural success (100% vs. 99.3%), 30-day TAVI-related major adverse cardiovascular events (13.9% vs. 17.1%), or permanent pacemaker implantation within 30 days (17.9% vs. 11.8%). There were two cases of cardiac tamponade in the RV group from the temporary lead; there were no guidewire related tamponades in the LV group.
Fourteen LV patients (9%) needed bailout with an RV lead because of new-onset left bundle branch block or atrioventricular block. The temporary pacing lead, meanwhile, was left in place in 38 RV patients (25%), which suggests “a lower threshold for an indwelling temporary pacing lead post procedure when there is already one in place,” the investigators said.
To deliver LV stimulation, the cathode of an external pacemaker was attached to the distal external end of the guidewire using a crocodile clip. A second crocodile clip – the anode – was attached to the incised skin at the sheath insertion site in the groin. The valve delivery system provided the required insulation.
The investigators noted that “the benefit of LV-stimulation may be less with self-expanding valves due to the significantly higher incidence of conduction disturbances requiring permanent pacemaker implantation post procedure.”
Patients were a mean age of 83 years, with about equal numbers of men and women. They had an intermediate risk of dying during the procedure. “However, we feel that the results are generalizable to the classical patient at high predicted risk of surgical mortality undergoing TAVI. Such patients tend to have higher rates of comorbidities, including peripheral vascular disease, placing them at higher risk of vascular complications and tend to have thinner RV walls, placing them at higher risk of RV-perforation,” the investigators said.
The work was funded by Edwards Lifesciences and others. Dr. Faurie had no disclosures. The senior author is a proctor for Edwards Lifesciences
SOURCE: Faurie B et al. TCT 2019. JACC Cardiovasc Interv. 2019 Sep 14. doi: 10.1016/j.jcin.2019.09.029.