A 79-year-old woman with non-ischemic severe mitral regurgitation (MR) presented with severe dyspnea New York Heart Association (NYHA) grade III. Her medical history included pulmonary hypertension, diabetes, chronic renal failure, and history of atrial fibrillation. At the time of the examination, she was treated with optimal anticongestive medical therapy. Transthoracic echocardiography showed a mildly impaired left ventricular ejection fraction (LVEF) of 52%, and left ventricular dilatation (left ventricular end-diastolic diameter 55 mm).
Due to high surgical risk (EuroScore II 3.83%) the heart team made the decision of an interventional approach with the Cardioband system (Valtech) for direct mitral valve annuloplasty (Figure 1). Based on cardiac computed tomography (CT) evaluation, a size D implant with 13 anchors was chosen.
After puncture of the right femoral vein, the guide wire was advanced into the right atrium. Transseptal puncture was performed under transesophageal echocardiographic (TEE) control; thereafter, the Cardioband sheath was advanced to the left atrium, followed by the Cardioband catheter. Placement of each anchor was confirmed via fluoroscopy (Figure 2) and TEE. Anchoring of the Cardioband device was started at P1 on the lateral side of the posterior mitral annulus. After implantation of all 13 anchors around the posterior mitral annulus, with the last anchor implanted at P3, step-by-step cinching of the Cardioband device led to significant reduction of mitral annular diameters. The catheter was afterwards detached from the implant and removed from the body.
The Cardioband procedure is performed under TEE control and without cardioplegia; thus, it is possible to directly assess procedural success and reduction of MR (Figure 3). MR was reduced to mild at the end of the procedure and it remained stable up to 2 years after the procedure (Figure 4A-B).
After successful implantation of the Cardioband device, the septo lateral diameter was reduced from 3.3 cm to 2.6 cm. At the time of discharge, TEE confirmed reduction of MR from severe to mild and NYHA class improved from III to I.
The annulus size, improvement in MR, and functional gains remained stable through 2 years of follow-up (Figure 4A-B). There was a clinically significant improvement in symptom scores including 6-minute walking distance test (6MWT) and quality of life (Minnesota Living with Heart Failure Questionnaire [MLHFQ]) from preoperative to last observation (Table 1). End-diastolic volume (EDV) was reduced by 16% and end-systolic volume (ESV) by 20% at 2 years, demonstrating left ventricular reverse remodeling.
Clinical follow-up of the patient after 1 and 2 years showed good functional improvement (Tables 1-2). After 2 years, she remained in NYHA class I, and 6-minute walking distance improved significantly after 1 year, but this test was not repeated after 2 years. Follow-up echocardiography showed positive remodeling of the left ventricle with significant reduction of left ventricular volumes.
Interventional mitral valve repair provided an option for treatment of MR-related symptoms in this case where medical therapy failed to improve the clinical and functional status. Of note, the Cardioband procedure does not interfere with the mitral valve apparatus, so that additional treatment procedures in case of relapse of MR, including valve replacement and open-heart surgery, remain possible.
In the first Cardioband cases, procedure duration was greater than 3 hours. In this case, total procedure time was relevantly less. Although the Cardioband procedure is challenging and it takes time to become familiar with the technique, it is not exceedingly difficult to learn.
Although not yet systematically proven, there is evidence that the Cardioband procedure results in reverse left ventricular remodeling. Further studies are needed to confirm this hypothesis. Current evidence proves that implantation of the Cardioband device reduces MR and heart failure symptoms, and increases exercise capacity; future studies will show if the functional and symptomatic improvement correlates with a reduction in morbidity and mortality.
Disclosure: The authors report participation in clinical trials sponsored by Valtech.
The authors can be contacted via Dr. Georg Nickenig at firstname.lastname@example.org.