J-Valve Transcatheter Treatment of Native Valve Aortic Regurgitation Associated With a Left Ventricular Assist Device

The use of left ventricular assist devices (LVAD) has expanded rapidly for both destination therapy and as a bridge to transplant.1Kirklin J.K. Naftel D.C. Pagani F.D. et al.Seventh INTERMACS annual report: 15,000 patients and counting.J Heart Lung Transplant. 2015; 34: 1495-1504Abstract Full Text Full Text PDF PubMed Scopus (1082) Google Scholar Aortic regurgitation (AR) can affect 15% to 52% of these patients after 1 year of LVAD support2Jorde U.P. Uriel N. Nahumi N. et al.Prevalence, significance, and management of aortic insufficiency in continuous flow left ventricular assist device recipients.Circ Heart Fail. 2014; 7: 310-319Crossref PubMed Scopus (151) Google Scholar,3Truby L.K. Garan A.R. Givens R.C. et al.Aortic Insufficiency During Contemporary Left Ventricular Assist Device Support: Analysis of the INTERMACS Registry.J Am Coll Cardiol HF. 2018; 6: 951-960Google Scholar and is often progressive. The proposed mechanisms underlying LVAD-related AR include leaflet deterioration, commissural fusion, aortic sinus dilatation, and increased transvalvular gradients, all of which alter normal hemodynamics and result in both risk of hospitalization and decreased survival.4Yoon S.H. Schmidt T. Bleiziffer S. et al.Transcatheter aortic valve replacement in pure native aortic valve regurgitation.J Am Coll Cardiol. 2017; 70: 2752-2763Crossref PubMed Scopus (155) Google Scholar Although treatment of LVAD-related AR with transcatheter heart valves (THV) designed for aortic stenosis has been reported in small series, the results have been poor owing to the lack of effective THV anchoring, increased risk of ventricular embolization, and occurrence of residual AR.4Yoon S.H. Schmidt T. Bleiziffer S. et al.Transcatheter aortic valve replacement in pure native aortic valve regurgitation.J Am Coll Cardiol. 2017; 70: 2752-2763Crossref PubMed Scopus (155) Google Scholar,5Cowger J. Rao V. Massey T. et al.Comprehensive review and suggested strategies for the detection and management of aortic insufficiency in patients with a continuous-flow left ventricular assist device.J Heart Lung Transplant. 2015; 34: 149-157Abstract Full Text Full Text PDF PubMed Scopus (78) Google Scholar The J-Valve (J.C. Medical) is an investigational THV particularly designed for the treatment of AR and consists of the following: (1) a self-expanding, low profile nitinol frame with bovine pericardial leaflets; (2) a valve locating feature consisting of 3 nitinol anchor rings designed to conform to the native aortic valve sinuses; and (3) sinus cutouts to facilitate coronary access and physiologic sinus washout (Figure 1). We report the first-in-human compassionate use of J-Valve for the treatment of severe, symptomatic AR in a 43-year-old man after continuous-flow LVAD (HeartMate III; Abbott Vascular) implantation (Figure 1). After recurrent New York Heart Association Functional Classification Class IV heart failure hospital admissions in the months preceding the procedure, consideration by a multidisciplinary heart team, and exclusion from the ALIGN-AR trial of the investigational JenaValve THV for treatment of severe AR, the patient was offered compassionate use treatment with J-Valve. The native valve comprised 3 leaflets and was noncalcified (Figure 1). The patient was approved for compassionate use treatment by The Christ Hospital Institutional Review Board and Center for Devices and Radiological Health before signing informed consent for the procedure. The procedure was performed in a hybrid catheterization laboratory under general anesthesia with transesophageal echocardiographic guidance. A 20F DrySeal sheath catheter (Gore Medical) was inserted through the right common femoral artery and a 31.0-mm J-Valve was inserted over a Safari guide wire (Boston Scientific) placed at the left ventricular apex. During deployment, the anchor rings were exposed in the ascending aorta, and the J-Valve was advanced to the aortic valve annulus with the anchor rings placed at the base of each sinus of Valsalva. Proper position was guided by transesophageal echocardiography and contrast injection in each cusp. Once the anchor rings were in position, the LVAD speed was reduced to 5200 rpm briefly, while the J-Valve was released without rapid pacing. After valve deployment, the LVAD speed was immediately increased to 6800 rpm, and postprocedural angiography revealed trace residual AR (Supplemental Video 1). The patient had rapid, symptomatic improvement and was discharged from hospital to home next day. Catheter-based treatment of severe AR related to LVAD support in patients with noncalcified, native aortic valves is challenging and fraught with the potential complications of THV migration, embolization, the requirement for an immediate additional THV or surgical conversion, and significant residual perivalve regurgitation. The J-Valve anchor rings co-apted the base of the noncalcified native valve leaflets within the sinus of Valsalva to effectively anchor and seal the THV as observed in the presented case. THV devices that do not rely on calcium for anchoring may provide an attractive alternative to redo surgery for patients with severe AR related to LVAD. The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.