The EVEREST II (Endovascular Valve Edge-to-Edge Repair Study) trial, a randomized comparison of percutaneous mitral repair and mitral-valve surgery, provided the basis of the FDA approval in addition to other registry data.1 EVEREST II showed that the percutaneous repair of the mitral valve was less effective at reducing MR than surgery before hospital discharge, but was associated with superior safety and similar rates of reduction in MR at 12 and 24 months.1,5
Saibal Kar, MD director of Cardiovascular Intervention Center Research at the Cedars-Sinai Heart Institute, explained the process of choosing suitable candidates for the MitraClip System in an interview with Cardiology Advisor.
“When a patient presents with significant MR, a proper clinical assessment should be made by cardiologist and cardiac surgeon proficient in the treatment of mitral valve disease. Based on the age of patient, and other comorbidities, the team can estimate the risk of open heart surgery. In addition there are certain standardized scoring systems such as the STS [Society of Thoracic Surgeons] or Euroscores, that can be employed to assess the surgical risk of a patient,” Dr Kar said.“In addition, each patient should undergo detailed echocardiographic assessment of the mitral valve which helps determine whether the lesion can be surgically repaired or amenable to treatment with the MitraClip. If a patient is considered to be high risk and the mitral valve pathology is suitable for the Clip, the patient should be offered the MitraClip therapy.”
In a recent report of early procedural outcomes of initial high-risk or inoperable patients who underwent MitraClip placement, Emily Downs, MD of the University of Virginia School of Medicine wrote, “The success of MitraClip depends heavily on a comprehensive heart team approach. Imaging experts are required to accurately characterize the mechanism of MR. Cardiologists, including heart failure specialists, are integral to the patient evaluation process, as it is often difficult to determine whether a given patient’s symptomatology can be attributed to MR vs ventricular dysfunction or lung disease.”1
Although the reduction in MR severity achieved by MitraClip implantation is typically durable in the majority of patients, MR may sometimes recur due to progression of the underlying disease or to loss of leaflet insertion (LLI) into the clip.6 A recent study published in JACC: Cardiovascular Interventions reported that of the 410 inoperable or high surgical risk patients treated with the MitraClip at the authors’ institution, 17 (4.1%) patients, as well as 4 patients initially treated at external institutions, underwent repeat MitraClip procedures.6 The repeat procedural success rate was 62%, which the authors called a “stark contrast” from the procedural success rate of 91% achieved in 402 index procedures.6 Only 25% of repeat interventions were successfully completed in the presence of LLI; 85% of were successful when leaflet insertion was adequate.6 The authors concluded that “repeat MitraClip intervention for significant recurrent MR appears to be a viable therapeutic approach in patients in whom leaflet insertion into the MitraClip is not compromised.”6
In contrast to US guidelines which recommend MitraClip only for degenerative MR, European guidelines recommend it for either degenerative or functional MR in patients with high surgical risk.
The Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy (COAPT) trial, currently recruiting participants in both the US and Canada, will examine the safety and efficacy of the MitraClip device used in addition to standard care for functional MR and heart failure compared to treatment with standard care alone.8 According to Dr Kar, results from this landmark clinical trial will help establish the role of MitraClip for functional MR.
- Downs EA, Lim DS, Saji M, Ailawadi G. Current state of transcatheter mitral valve repair with the MitraClip. Ann Cardiothorac Surg. 2015;4(4):335-340. doi:10.3978/j.issn.2225-319X.2015.02.02.
- Taramasso M, Candreva A, Pozzoli A, et al. Current challenges in interventional mitral valve treatment. J Thorac Dis. 2015;7(9):1536-1542. doi: 10.3978/j.issn.2072-1439.2015.04.58.
- Goel SS, Bajaj N, Aggarwal B, et al. Prevalence and outcomes of unoperated patients with severe symptomatic mitral regurgitation and heart failure: comprehensive analysis to determine the potential role of MitraClip for this unmet need. J Am Coll Cardiol. 2014;63(2):185-186. doi:10.1016/j.jacc.2013.08.723.
- Deuschl F, Schofer N, Lubos E, et al. MitraClip-data analysis of contemporary literature. J Thorac Dis. 2015;7(9):1509-1517. doi:10.3978/j.issn.2072-1439.2015.07.38.
- Candreva A, Maisano F, Taramasso M. MitraClip and Transcatheter Aortic Valve Implantation (TAVI): State of the Art 2015. Curr Heart Fail Rep. 2015. doi:10.1007/s11897-015-0275-3.
- Kreidel F, Frerker C, Schlüter M, et al. Repeat MitraClip Therapy for Significant Recurrent Mitral Regurgitation in High Surgical Risk Patients: Impact of Loss of Leaflet Insertion. JACC Cardiovasc Interv. 2015;8(11):1480-1489. doi:10.1016/j.jcin.2015.06.019.
- Tamburino C, Ussia GP, Maisano F, et al. Percutaneous mitral valve repair with the MitraClip system: acute results from a real world setting. Eur Heart J. 2010;31:1382-1389. doi: 10.1093/eurheartj/ehq051.
- Clinical Outcomes Assessment of the MitraClip Percutaneous Therapy (COAPT) Trial for Functional Mitral Regurgitation. http://www.coapttrial.com/home. Published 2014. Accessed December 16, 2015.