Transcatheter Aortic Valve Replacement for Severe Aortic Regurgitation in Patients With a Left Ventricular Assist Device

Abstract

Background. There are limited invasive treatment options for patients with end-stage heart failure and left ventricular assist device (LVAD) who develop severe aortic valve regurgitation (AR). One option for such patients is transcatheter aortic valve replacement (TAVR). There are limited data on outcomes of patients with LVAD who receive TAVR for severe AR. We present a series of 4 consecutive patients with LVAD who underwent TAVR for severe AR. Methods and Results. This is a retrospective chart review of 4 consecutive patients with LVAD who underwent TAVR for severe AR. All 4 patients underwent TAVR with a 34-mm self-expanding valve (Medtronic). One patient received a 29-mm balloon-expandable valve (Edwards Lifesciences) within the self-expanding valve (SEV) to postdilate the SEV and minimize paravalvular leak (PVL). All 4 procedures were technically successful. The patient who received rescue valve-in-valve TAVR continued to have persistent mild to moderate PVL. Conclusion. Although technically challenging, TAVR is a feasible option for carefully selected LVAD patients with severe AR. Procedural issues to consider include oversizing the transcatheter heart valve (THV) while being cognizant of the risks of annular rupture and valve dislocation, anticipating and avoiding ventricular migration of the THV and being ready to postdilate the THV if necessary, to limit hemodynamically significant PVL.

J INVASIVE CARDIOL 2022;34(5):E369-E373. Epub 2022 March 25.

Key words: aortic incompetence, continuous-flow left ventricular assist device, end-stage heart failure, transcatheter aortic valve implantation

Patients with end-stage heart failure are increasingly being managed with left ventricular assist devices (LVADs), either as a bridge to heart transplant or as “destination therapy.” With the increasing prevalence of end-stage heart failure and the low availability of donor hearts for transplant, LVAD therapy is being used with increasing frequency. Prolonged LVAD support can induce hemodynamic and structural variations in the aortic root that predispose patients to develop aortic regurgitation (AR). As such, patients with LVADs are at a high risk of developing AR.^1-3 It has been shown that up to one-third of all patients with long-term LVADs develop hemodynamically significant AR.^2-7 Severe AR in patients with LVAD leads to decompensated heart failure due to the constant loop of flow between the ascending aorta and the LVAD, resulting in poor cardiac output despite seemingly normal LVAD pump function. Patients with LVADs and severe AR are high-risk candidates for surgical replacement of the aortic valve due to their clinical presentation of acute heart failure and frequent medical comorbidities. As such, there are limited therapeutic options for this patient subset. Transcatheter aortic valve replacement (TAVR) is a possible option to treat severe AR in patients with LVADs.⁸

Methods

This is a retrospective chart review of consecutive patients with LVAD who underwent TAVR for severe AR between June 1, 2017 and July 31, 2020. The study was approved by the local institutional review board, and data were collected from chart review and the valve registry. For procedural planning and decision making, patients were evaluated with a multidisciplinary heart team comprised of advanced heart failure cardiologists, interventional cardiologists, and cardiothoracic surgeons. Preprocedure echocardiography and computerized tomographic angiography of the chest, abdomen, and pelvis were performed in all patients. All patients required hospital admission prior to TAVR due to clinical instability and deteriorating hemodynamics and were unable to be stabilized on medical therapy.

Procedural planning. Patients with LVADs are prone to develop cytostructural variations in the aortic root, with ensuing aortic root dilation. Our approach to valve selection in these patients involves deploying the largest-possible self-expanding valve (SEV) due to its large supravalvular nitinol frame, which helps anchor the valve above the sinotubular junction in the ascending aorta and minimizes ventricular migration. If the valve migrates toward the left ventricle, we deploy a balloon-expandable valve (BEV) within the SEV frame at the level of the aortic annulus with extra volume in the delivery balloon to help anchor the valve. It is important to note that oversizing of the transcatheter heart valve (THV) leads to a higher risk of valve dislocation, conduction disorders, and annular rupture.

Procedural technique. A 34-mm Evolute SEV (Medtronic) is advanced over a double-curve Lunderquist wire (Cook Medical) and positioned within the aortic annulus. Aortic root injections are performed. Without pacing, the valve is slowly deployed to 80% with repeated aortic root injections and transthoracic echocardiographic evaluation. The valve is observed in this position for 5-10 minutes to see if it appears to be migrating into the left ventricle. The LVAD flow rate is slowed and with rapid pacing the valve is then released (Figure 1 and Figure 2). Rapid pacing is discontinued. Over 5-10 minutes, the LVAD flow rate is ramped up to baseline rotations/minute with continuous observation under echocardiography and cine angiography. Procedural variables are listed in Table 2. All 4 of our patients underwent TAVR with a 34-mm Evolut SEV (Medtronic). For patient 4, who developed moderate paravalvular leak (PVL) with ventricular migration of the SEV, we deployed a 29-mm Sapien 3 BEV (Edwards Lifesciences) within the SEV, with fluoroscopically visible expansion of the “waist” of the SEV (Figure 3 and Figure 4).

Results

Four consecutive patients with pre-existing LVADs received TAVR for severe AR. Baseline clinical characteristics are presented in Table 1. All 4 patients received a 34-mm Evolut SEV. One patient underwent valve-in-valve TAVR with a 29-mm Sapien 3 BEV during the index TAVR. There was no central valvular AR after TAVR in any of the patients. Patient 4 had a moderate to severe PVL that improved after valve-in-valve TAVR with 29-mm BEV, but continued with persistent mild to moderate PVL. Procedural characteristics are outlined in Table 2.

Post-TAVR outcomes. Clinical outcomes are outlined in Table 3. All 4 patients were optimized medically and successfully discharged within 2-5 days post TAVR.

Patient details. Patient 1 presented after 1 month due to pneumonia and was found to be in septic shock. Despite aggressive medical management, their condition deteriorated and comfort care measures were initiated. Patient 2 recovered satisfactorily and has not had any heart failure admissions since their TAVR. Patient 3 had 1 heart failure hospitalization more than 1 month post TAVR, and was discharged after 5 days of intravenous diuresis and medication optimization. They were admitted again at 2 months post TAVR and were found to have LVAD thrombosis. Despite aggressive intravenous anticoagulation and antiplatelet therapy, LVAD flows did not improve. The LVAD was explanted and the patient passed away shortly thereafter. Patient 4 presented within 1 week after discharge due to decompensated congestive heart failure. This patient had a residual moderate PVL after TAVR. After a heart team discussion with the advanced heart failure team, cardiothoracic surgery, and interventional cardiology, the decision was made to make a final attempt at percutaneous management of the PVL. The patient was noted to have AR through the interstices of the SEV frame, above the valve-in-valve BEV frame. This was due to ventricular shift of the SEV frame. The planned strategy was for repeat valve-in-valve TAVR with a superiorly placed TAVR prosthesis in order to close off the origin of the PVL. Despite multiple attempts, the THV could not be crossed from the aortic side. Next, an attempt was made to cross the aortic valve from the ventricular side. Trans-septal puncture was performed with a BRK needle (St Jude Medical) and a Swartz sheath (St Jude Medical) using transesophageal echocardiographic guidance. Multiple catheters and wires were unable to cross the TAVR prosthesis from the ventricular side. This confirmed the suspicion that there was fusion of the valve leaflets. A final attempt was made to deploy a percutaneous occluder device from the aortic side to seal the valve at the level of the PVL. A 24-mm Amplatzer septal occluder (ASO) device (Abbott) was deployed and immediately deformed into a “cobra deformity.” The ASO was removed from the body. A 30-mm Amplatzer cribriform ASO device was then deployed and repositioned multiple times, but did not result in improvement in aortic insufficiency and was removed from the body.

Discussion

TAVR is well established as a treatment option for severe symptomatic aortic stenosis.⁹ Furthermore, TAVR is being increasingly considered in a subset of patients with aortic incompetence who have limited surgical options.^10-12 Patients with LVAD who develop hemodynamically significant aortic incompetence present a unique challenge. They frequently have coexisting medical conditions that make open surgical aortic valve replacement a prohibitively high-risk option. TAVR can be considered in these patients, although it is important to recognize the anatomic challenges due to inadequate calcification for anchoring the THV, annular dilation, and high flow rates in the ascending aorta from the LVAD outflow cannula. There is an increased risk of inadequate sealing, valve embolization, and significant PVL. There are limited procedural and outcomes data for the use of TAVR in LVAD patients. One meta-analysis found that in 29 patients with LVAD who underwent transcatheter management of AR, 28% underwent TAVR and 72% were treated with an occluder device.¹³ Smaller case series of TAVR in LVAD patients with AR demonstrate that while there is a high rate of procedural success, it is important to anticipate complications, such as device migration, PVL, and vascular complications.¹⁴

The self-expanding THV platform is preferred over BEVs in these patients with pure native AR because the radial force of the nitinol frame may help securely anchor the valve even in the absence of annular calcification. Another transcatheter option is to deploy a percutaneous occluder device to seal off the aortic valve. However, this maneuver makes the patient completely dependent on the LVAD flow, with no rescue outlet for the left ventricle if the LVAD fails. Newer technologies for percutaneous aortic valve replacement in patients with pure native AR are being developed. The JenaValve THV (JenaValve Technology, Inc) employs a clipping mechanism with positioning feelers to dock into the native aortic annulus. Initial experience and outcomes with this THV appear to be promising.¹⁵ The J-Valve THV (JC Medical, Inc) has a system comprising 3 anchoring rings that align with the aortic sinuses and clasp the native aortic valve leaflets. Once the rings are positioned, the J-Valve SEV is deployed within the anchor rings. A successful first-in-human transfemoral implantation of the J-Valve has been reported.¹⁶

Conclusion

Aortic regurgitation in patients with LVADs is difficult to manage. TAVR with newer-generation THVs is a promising treatment option for these patients. We were able to achieve procedural success in all 4 of our patients, and all 4 were successfully discharged from the hospital. We had a procedure-related complication in 1 patient who developed leaflet fusion and hemodynamically significant PVL that could not be treated with a transcatheter option despite our best efforts. Two of our patients developed non-valvular complications (septic shock and LVAD thrombosis). These results are sobering. Although procedural success and resolution of aortic incompetence can be achieved in these patients, they remain at high risk of other complications.

Affiliations and Disclosures

From the Providence Heart and Vascular Institute, Portland, Oregon.

Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. The authors report no conflicts of interest regarding the content herein.

Manuscript accepted June 26, 2021.

The authors report that patient consent was provided for the images used herein.

Address for correspondence: Ashwat S. Dhillon, MD, Providence Valve Center, 9427 SW Barnes Road, West Pavilion, 5th Floor, Suite 593, Portland, OR 97225. Email: ashwatdhillon@gmail.com

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