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The Society for Cardiovascular Angiography and Interventions 1100 17th Street NW, Suite 330, Washington, DC 20036 (800) 992-7224 Fax (800) 863-5202 e-mail: [email protected] www.scai.org ID: O-009 Session Title/Time/Location: Best of the Best Oral Abstract Presentations/Thursday, May 29, 2014, 1:00 pm-3:00 pm (Pacific Time)/Octavius 24 Corevalve Transcatheter Aortic Valve Implantation Using the Novel Transcaval Approach: First in Man Experience Category: Valvular Interventions and Structural Heart Disease Authors: Vikas Singh, Interventional Concepts, INC, United States; Pedro Martinez-Clark, Interventional Concepts, INC, United States; Cesia Gallegos, Interventional Concepts, INC, United States; Jairo Cadena, Angiografia de Occidente S.A. Cali - Colombia, Colombia; Angela Cucalon, Angiografia de Occidente S.A. Cali - Colombia, Colombia; Antonio Dager, Angiografia de Occidente S.A. Cali - Colombia, Colombia; William W. O'Neill, Henry Ford Health System, United States Background: Approximately two thirds of screened patients with aortic stenosis (AS) are not suitable for the trans-femoral transcatheter aortic valve replacement (TAVR) approach due to peripheral arterial disease. Despite the availability of multiple access options such as transaortic or subclavian/trans-axillary, more than 3% of patients have anatomic features making none of these approaches feasible. We report our first in man experience and demonstrate intra-procedural safety of TAVR with self-expandable Medtronic-CoreValve ReValving system (CRS) using retrograde trans-caval approach in a subgroup of inoperable patients with severe AS. Methods: Through standard right femoral vein access, a stiff 0.014” guidewire (Asahi Confianza Pro 12) inside a 0.035” wire converter (Piggyback Vascular Solutions) was loaded on a 5 French cobra catheter. The distal end of the guidewire was connected to the cautery set in cut mode at 50 Watts. A vascular EV3 GooseNeck snare was positioned in the distal aorta and was used to capture the guidewirefrom the vena cava. Once, the entire system was in position, and with the guidewire pointing to the snare in the aorta the cautery was turned on and the wire advanced from the inferior vena cava to the distal aorta through the lumen of the snare. The wire was then captured in the snare and advanced to the ascending aortic curvature and the piggy-back wire would be advanced loaded on a .035” quickcross catheter. Once in the aortic arch, the piggy-back and the guidewire would be removed and a 0.35” quickcross catheter is left in the aortic arch in order to exchange for a 0.035-inch Amplatz super stiff guidewire. A 18F 40cm Cook introducer sheath was introduced from the venous access connecting femoral vein to aorta. The self-expanding CRS is mounted in the catheter system and then advanced to the left ventricular outflow tract to be delivered in the native anatomy. The distal two thirds of the valve were released in a controlled manner with the transitory pacemaker at a heart rate of 120 beats per minute. Once position was verified, the pigtail catheter was retracted to the aortic arch and the valve was delivered. Closure of the aorto-caval fistula was completed with an Amplatzer VSD Muscular Device. Arterial hemostasis was achieved using either manual pressure or a vascular closure device: Angioseal or Proglide. Results: We successfully performed trans-caval TAVR in 3 patients with mean age of 81±10.4 years (2 women and 1 man), mean Society of Thoracic Surgeons predicted risk of mortality of 8.1± 6% and mean Logistic EuroSCORE of 9.1±6%. All patients had severe AS (aortic valve area <0.8cm2, mean aortic-valve gradient ≥40mm Hg or peak Doppler aortic jet velocity ≥4.0 m/sec) and had congestive heart failure with New York Heart Association (NYHA) class III or IV symptoms. They were deemed inoperable by cardiac surgeons because surgical aortic valve replacement would be associated with a predicted probability of ≥50% of death within 30 days after surgery or development of a serious irreversible complication. All patients had peripheral arterial disease and contraindications for both trans-aortic or subclavian/trans-axillary access. Valve sizes were 26, 29 and 31mm. One patient required permanent pacemaker placement however there were no other complications per Valve Academic Research Consortium criteria. The mean NYHA class improved from 3.3 to 1.3 and the mean aortic valve area increased from 0.46 to 1.9cm2. At 6 months follow up all patients were free of re-hospitalization and noted a significant improvement in functional capacity. Conclusions: CoreValve percutaneous aortic valve replacement using trans-caval approach is a feasible option especially in a subgroup of patients with contraindications to other access. Prospective assessment of the safety and efficacy of this approach warrants further study with larger number of patients. Author Disclosures: 1. Vikas Singh: This author has nothing to disclose. 2. Pedro Martinez-Clark: This author has nothing to disclose. 3. Cesia Gallegos: This author has nothing to disclose. 4. Jairo Cadena: This author has nothing to disclose. 5. Angela Cucalon: This author has nothing to disclose. 6. Antonio Dager: This author has nothing to disclose. 7. William W. O'Neill: This author has nothing to disclose.