Transfemoral Clinical Experience
- Excellent clinical results in more than 20,000 CoreValve procedures performed in over 40 countries2
- 98% procedural success rate reported in seven national registries3
- Stroke rate below 3%3
- More than 80% of patients demonstrated symptomatic improvements of at least one NYHA heart-failure class after their procedure4
Subclavian Clinical Experience
- High procedural success rates5-8
- Low complication rates, including low incidence of vascular complications.6-8
- 30-day all-cause mortality and major cardiovascular or cerebrovascular event (MACCE) rates similar to transfemoral implantation6-8
- Rapid mobilization of patients following procedure6-8
Clinical Experience
CoreValve Transcatheter Aortic Valve Implantation received CE-Mark approval for the treatment of severe Aortic Stenosis in 2007. To date, more than 20,000 patients in 40 countries have undergone the CoreValve procedure.
NYHA Heart Class Improvements
Most patients receiving a CoreValve heart valve can expect immediate symptom relief. In several studies, more than 80% of patients reported symptomatic improvements of at least one NYHA heart failure class after their procedure.1
Quality of Life Improvements
Patients also reported significant improvements in quality of life measurements.2
References
- Moynagh AM, Scott DJ, Baumback H, Khavandi A, Brecker SJ, Laborde JC, et al. CoreValve transcatheter aortic valve implantation via the subclavian artery: comparison with the transfemoral approach. J Am Coll Cardiol. 2011;57:634-35.
- Modine T, Obadia JF, Choukroun E, Rioufoul G, Sudre A, Laborde JC, et al. Transcutaneous aortic valve implantation using the axillary/subclavian access: feasibility and early clinical outcomes. J Thorac Cardiovasc Surg. 2011 Feb; 141:487-491.
- Laborde JC on behalf of the PAVR Registry participants. Aortic valve implantation by subclavian access site. Presented at EuroPCR 2009. May 19-22, 2009. Barcelona, Spain.
- Verkroost MW, Gehlmann HR, Besjes MJ, van Dijk AP, Noyez L, van Swieten HA, et al. Preferential use of the left subclavian artery for transcatheter aortic valve implantation: the Nijmegen experience. Poster. TCT 2010. September 21-25, 2010. Washington, D.C.
Important Risk Information
As with any cardiac catheterization procedure, certain complications may occur. Cardiac catheterization, including implantation of the CoreValve Aortic Valve, has been associated with serious complications including heart attack, stroke and death.
In clinical studies, a small number of patients who received the CoreValve® experienced additional adverse events during or after the procedure which included but was not limited to:
- Complications at the vascular access site (e.g., pain, bleeding, bruising)
- Disruption of the normal electrical conduction system of the heart which may require treatment with a pacemaker
- Aortic regurgitation (leaking of the aortic valve that allows some blood to flow in the reverse direction)
For the Instructions for Use documentation, contact Medtronic LifeLine Technical Support at rs.cstechsupport@medtronic.com or +1 (763) 526-7890 (USA).
Subclavian Procedure Risk Information
Implanting a bioprosthesis should generally be avoided in patients with any of the following conditions: a high risk of bleeding (e.g., patients with recently active gastritis or peptic ulcer disease); pre-existing morbid conditions that increase the risk of poor initial results or the risk of emergency referral for bypass surgery (e.g., diabetes mellitus, renal failure and severe obesity); or severe angulation (>30°) of the aortic valve annular plane (right subclavian use only).
- Use caution in patients with pre-existing patent Left Internal Mammary Artery/Right Internal Mammary Artery (LIMA/RIMA) graft (subclavian access only).