The Cardiovascular Institute at the GHM Grenoble hospital site has developed a disruptive new interventional cardiology operating technique. The results of the EASY-TAVI clinical trial, which presents one of the steps in the transcatheter aortic valve implantation procedure, have been published in the Journal of the American College of Cardiology Intervention.
Aortic stenosis is the most common primary valve disease in the Western world, with the risk increasing with age. “It is life-threatening in the short to medium term, i.e., within 2 to 5 years(1)”, indicates the French National Agency for Medicines and Health Products Safety (ANSM) in its report on cardiac valves.
The first TAVI procedures were performed in the early 2000s in Caen by Prof. Alain Cribier, a pioneer in this field(2). Improvements in the procedure - not only in TAVI itself but also in perioperative care - have made it possible to extend its indications, firstly to patients with contraindications to surgery, and secondly to those presenting very high surgical risks.
1| A new technique
A new interventional cardiology operating technique has been developed by the Cardiovascular Institute at the GHM Grenoble hospital site, one of France’s national reference centers for cardiology. This new technique, incorporated within the EASY-TAVI (Transcatheter aortic valve implantation) study in France, was used in the first case of outpatient aortic valve implantation. The results of this new operating technique were presented at the American Transcatheter Cardiovascular Therapeutics (TCT) Congress in San Francisco in September 2019 and are very promising(5).
2| “The device development process was very long”
The EASY-TAVI study, which lasted 12 months (from May 2017 to May 2018) concerned 10 French institutions and included a total of 303 patients (307 initially with 4 subjects excluded for not having received the compulsory preoperative treatment)(5).
The technique used was developed by cardiologist Dr Faurie Benjamin with a view to offering a less invasive approach, to enable patients to be discharged from hospital earlier. The cardiologist explains that the device development process was a long one but that the bleeding risk is lower with this technique(6).
3| Time savings and a 100% success rate
The study indicated, firstly, a significant time saving with the procedure (48.4 ± 16.9 min vs. 55.6 ± 26.9 min; p = 0.0013) as well as a reduction in procedure costs (€18,807 ± 1,318 vs. €19,437 ± 2,318; p = 0.001) while maintaining a high level of efficacy.
The technique is particularly encouraging since the success rate for the procedure is 100%(5).
- Valves cardiaques pour les nouvelles voies d’abord endo-vasculaire et transapicale (bioprothèses valvulaires aortiques et pulmonaires par voie transcathéter). Rapport ANSM, Décembre 2016.
- Benamer H, Auffret V, Cyala G et coll. Position papier français (GACI) pour l'implantation de valve aortique percutanée (TAVI). Arch Mal Coeur Vaiss Prat 2018;2018:32–40 . doi : 10.1016/j.amcp.2018.10.004.
- Kodali SK, Williams MR, Smith CR et coll. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med. 2012 May3;366(18):1686-95. doi: 10.1056/NEJMoa1200384.
- Adams DH, Popma JJ, Reardon MJ et coll. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl JMed. 2014 May 8;370(19):1790-8. doi: 10.1056/NEJMoa1400590.
- Faurie B et al. Left Ventricular Rapid Pacing Via the Valve Delivery Guidewire in Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. 2019 Dec 23;12(24):2449-2459. Doi : 10.1016/j.jcin.2019.09.029.