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SUPRASTERNAL DIRECT AORTIC TRANSCATHETER AORTIC VALVE REPLACEMENT AVOIDS STERNOTOMY, THORACOTOMY AND FEMORAL ACCESS: FIRST IN MAN EXPERIENCE

2015; Elsevier BV; Volume: 31; Issue: 10 Linguagem: Inglês

10.1016/j.cjca.2015.07.442

1916-7075

Mark D. Peterson, Chris Buller, Asim N. Cheema, David A. Latter, H. Kim, Richard S. Stack, Andy C. Kiser,

Aortic Disease and Treatment Approaches

Transfemoral, transapical and conventional direct aortic TAVR patients have incisional morbidity that may delay ambulation and discharge. We evaluated the feasibility of direct aortic or innominate access for deployment of a transcatheter aortic valve using a novel suprasternal aortic access system without bony disruption or femoral instrumentation. Two patients with severe, symptomatic aortic stenosis at very high risk for conventional AVR (mean: age 82.5 years, STS predicted mortality 20%) but who were poor candidates for transfemoral or transapical valve delivery were consented for TAVR with the suprasternal aortic access system following Health Canada Special Access approval. This novel system includes a specially shaped, radiolucent trocar that combines internal illumination for direct visualization and an external stabilizer connected directly to the table to provide a motionless, hands free, retracted surgical field. The system is positioned under general anesthesia through a 3 cm incision above the sternal notch. The suprasternal aortic access system was successfully positioned with direct visualization and instrumentation of the aorta and innominate artery in both patients. A pigtail catheter placed via the radial artery provided aortography and facilitated valve positioning in combination with the axial control inherent to direct aortic approaches. Both Edwards Sapien XT valves were deployed with VARC-2 procedural success. Importantly, purse string suture placement, sheath insertion, precise valve positioning and hemostatic sheath removal all proved feasible through the stabilized suprasternal aortic access system without chest wall incision or bony disruption. Mean fluoroscopy times, radiation and contrast doses were 14 min, 2373 mGy and 68 ml respectively (n=2). Both patients were extubated in the operating room and experienced minimal incisional discomfort. Despite their complex co-morbidities, both patients were mobilized the day of surgery and discharged home on the second postoperative day with normally functioning bioprosthetic valves (mean gradient 11 mmHg, paravalvular regurgitation: none and trace, n=2). The suprasternal approach employing the suprasternal aortic access system enables direct axial valve positioning and avoids sternal/thoracotomy incisions and femoral access. Early mobilization is possible and likely expedites recovery. This innovative system creates a novel minimally invasive approach for high-risk patients with aortic stenosis. A multicenter clinical evaluation is underway.