LAS VEGAS — Use of transcaval access to perform transcatheter aortic valve replacement with the CoreValve self-expanding system was successful in the first three patients in which it was attempted, according to a presentation at the Society for Cardiovascular Angiography and Interventions Scientific Sessions.
TAVR has traditionally been performed via the arteries, not the veins. However, the three patients were not candidates for the transfemoral, transaortic, subclavian or transaxillary approaches, nor for surgery, Vikas Singh, MD, cardiology fellow at the University of Miami, said here.
Unmet medical need
In fact, Singh said, 20% to 30% of screened patients with aortic stenosis are not candidates for transfemoral TAVR because of peripheral arterial disease, and nearly 3% of screened candidates cannot undergo TAVR via any arterial access.
“The rationale for using iliofemoral [vein] access is very simple: The veins are larger and more compliant [than arteries], they can accommodate a larger sheath, and they are very closely located to the abdominal aorta,” Singh said during a presentation.
The three patients, two women and one man, had a mean age of 81 years, mean Society of Thoracic Surgeons predicted risk of mortality of 8.1% and mean Logistic EuroSCORE of 9.1%. All patients had severe aortic stenosis, defined as aortic valve area <0.8 cm2, mean aortic-valve gradient ≥40 mm Hg or peak Doppler aortic jet velocity ≥4 m/sec, and had NYHA class III or IV congestive HF, Singh said.
Cardiac surgeons had deemed these patients as inoperable due to a predicted probability of ≥50% of death within 30 days after surgery or development of a serious irreversible complication, Singh said.
The patients underwent TAVR with CoreValve (Medtronic) via transcaval access. One patient received a 26-mm valve, one received a 29-mm valve and one received a 31-mm valve, Singh said.
Equipment used in the procedure included a stiff 0.014” guidewire (Asahi Confianza Pro 12) inside a 0.035” wire converter (Piggyback Vascular Solutions) on a 5 French cobra catheter, a cautery set, a GooseNeck snare (EV3), an 18 French 40 cm introducer sheath (Cook Medical) and an Amplatzer VSD Muscular Device, according to Singh.
The guidewire was threaded from the femoral vein in the groin into the inferior vena cava, and then in the abdomen, the cautery device in both blood vessels, connecting the venous and arterial systems, he said. The snare captured the guidewire and pulled it into the aorta, and the other tools were threaded through the femoral vein to the inferior vena cava and then to the aorta, after which the CoreValve was deployed as in any other TAVR procedure, he noted.
One patient required implantation of a pacemaker, he said.
Free from complications
At 6 months, all three patients were free from complications and showed significant improvement in functional capacity. Mean NYHA class improved from 3.3 to 1.3.
“Iliofemoral access for CoreValve implantation is feasible,” Singh said. “We need more data on it and I believe this approach should be compared with all nontransfemoral access options, such as subclavian or transaxillary access or hybrid surgical options.”
Since the data were compiled from the first three patients, the procedure has been performed in six more, with similar results, he noted. Researchers have also begun to use the transcaval approach with the Sapien family of balloon-expandable systems (Edwards Lifesciences), he said.
Singh’s presentation won an award for best abstract at the sessions. – by Erik Swain
For more information:
Singh V. Best of the Best Abstracts: Abstract O-009. Presented at: the Society for Cardiovascular Angiography and Interventions Scientific Sessions; May 28-31, 2014; Las Vegas.
Disclosure: Singh reports no relevant financial disclosures.