The aims of the echocardiographic substudy of this multicenter trial were to evaluate
the use of quantitative assessment of mitral regurgitation (MR) severity using serial
echocardiography and to assess the efficacy of percutaneous mitral valve repair. Previous
surgical repair studies did not use quantitative echocardiographic methods. Results
of a percutaneous mitral valve repair clip device in a core echocardiographic laboratory
were evaluated. Published parameters for quantifying MR were used in a systematic
protocol to qualify patients for study entry and evaluate treatment efficacy at discharge
and 6 months after clip repair. Baseline results were presented for 55 patients, and
follow-up results, for 49. Ninety-eight percent of required echocardiographic studies
were submitted to the core laboratory, and >85% of required measurements were possible.
At baseline, mean regurgitant volume was 54.8 ± 24 ml, regurgitant fraction was 46.9
±16.2%, effective regurgitant orifice area was 0.71 ± 0.40 cm2, and vena contracta width was 0.66 ± 0.20 cm. Based on a severity scale of 1 to 4,
mean color flow grade was 3.4 ± 0.7, and mean pulmonary vein flow was 2.8 ± 1.2. In
patients with a clip at 6 months, all measurements of MR severity were significantly
decreased versus baseline, with mean regurgitant volume decreased from 50.3 to 27.5
ml (change −22.8 ml; p <0.0001), regurgitant fraction from 44.6% to 28.9% (change
−15.7%; p <0.0001), color flow grade from an average of 3.4 to 1.8 (change −1.6; p
<0.0001), and pulmonary vein flow from 2.8 to 1.8 (change −1.0; p <0.0018). In conclusion,
quantitative assessment of MR is feasible in a multicenter trial, and percutaneous
mitral repair with the MitraClip produces a sustained decrease in MR severity to moderate
or less for ≥6 months.
To read this article in full you will need to make a payment
Purchase one-time access:
Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online accessOne-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
Subscribe:
Subscribe to American Journal of CardiologyAlready a print subscriber? Claim online access
Already an online subscriber? Sign in
Register: Create an account
Institutional Access: Sign in to ScienceDirect
References
- Beating heart catheter-based edge-to-edge mitral valve procedure in a porcine model: efficacy and healing response.Circulation. 2004; 110: 988-993
- Endovascular edge-to-edge mitral valve repair: short-term results in a porcine model.Circulation. 2003; 108: 1990-1993
- Percutaneous mitral valve repair using the edge-to-edge technique: six-month results of the EVEREST phase I clinical trial.J Am Coll Cardiol. 2005; 46: 2134-2140
- Percutaneous mitral valve repair with the edge-to-edge technique: a surgeon’s perspective.J Am Coll Cardiol. 2005; 46: 2141-2142
- Recommendations for evaluation of the severity of native valvular regurgitation with two-dimensional and Doppler echocardiography.J Am Soc Echocardiogr. 2003; 16: 777-802
- ACC/AHA guidelines for the management of patients with valvular heart disease.Circulation. 1998; 98: 1949-1984
- Assessment of mitral regurgitation severity by Doppler color flow mapping of the vena contracta.Circulation. 1997; 95: 636-642
- Quantitation of mitral regurgitation by Doppler echocardiography.Circulation. 1986; 74: 306-314
- Surgical revision after percutaneous mitral valve repair with a clip: initial multicenter experience.Ann Thorac Surg. 2005; 80: 2338-2342
- American Society of Echocardiography recommendations for use of echocardiography in clinical trials.J Am Soc Echocardiog. 2004; 17: 1086-1119
- Mitral valve surgery in heart failure: insights from the Acorn Clinical Trial.J Thorac Cardiovasc Surg. 2006; 132: 568-577
- Very long-term results (more than 20 years) of valve repair with Carpentier’s techniques in nonrheumatic mitral valve insufficiency.Circulation. 2001; 104: I8-I11
- Recurrence of mitral valve regurgitation after mitral valve repair in degenerative valve disease.Circulation. 2003; 107: 1609-1613
- Recurrent mitral regurgitation after annuloplasty for functional ischemic mitral regurgitation.J Thorac Cardiovasc Surg. 2004; 128: 916-924
- Midterm results of edge-to-edge mitral valve repair without annuloplasty.J Thorac Cardiovasc Surg. 2003; 126: 1987-1997
- Effects of afterload reduction on vena contracta width in mitral regurgitation.J Am Coll Cardiol. 1998; 32: 427-431
- Quantitative determinants of the outcome of asymptomatic mitral regurgitation.N Engl J Med. 2005; 352: 875-883
- Impact of wall constraint on velocity distribution in proximal flow convergence zone.J Am Coll Cardiol. 1996; 27: 706-713
- Similar long-term results of mitral valve repair for anterior compared with posterior leaflet prolapse.J Thorac Cardiovasc Surg. 2006; 131: 364-370
- The double orifice technique as a standardized approach to treat mitral regurgitation due to severe myxomatous disease: surgical technique.Eur J Cardiothorac Surg. 2000; 17: 201-215
- Current status of flow convergence for clinical applications: is it a leaning tower of “PISA”?.J Am Coll Cardiol. 1996; 27: 504-509
Article info
Publication history
Accepted:
June 14,
2007
Received in revised form:
June 14,
2007
Received:
April 17,
2007
Footnotes
This study was supported by a grant from Evalve, Inc., Menlo Park, California.
Clinical Trial Registration: www.clinicaltrials.gov, Evalve no. 0301.
Identification
Copyright
© 2007 Elsevier Inc. Published by Elsevier Inc. All rights reserved.
