Abstract: Paravalvular leak (PVL) following aortic valve implantation is a rare complication but may cause potentially serious consequences. It occurs in 2%-10% of surgical aortic valve replacements and 7%-17% of surgical mitral valve replacements. Transcatheter valve replacement data show that significant PVL occurs in 6%-8% of cases. The management of significant PVL has traditionally involved repeat surgical repair. However, many of these patients are considered too high risk to undergo a repeat surgical procedure; hence, a percutaneous transcatheter approach has often been utilized to treat these patients. Vascular plugs have been used to close PVLs, with variable results; the procedure is complex and technically demanding. Transcatheter aortic valve replacement, using a valve-in-valve approach, may provide an alternative approach for bioprosthetic PVL in the aortic position.
J INVASIVE CARDIOL 2017;29(1):E1-E7.
Key words: paravalvular leak, vascular plugs
Senile aortic valve stenosis is one of the most common valvular heart diseases, with significant morbidity and mortality if left untreated.1 Both surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR) are currently used to treat this condition.
Significant paravalvular leak (PVL) following either SAVR or TAVR is uncommon.2 When it does occur, however, the presence of PVL can lead to significant complications including heart failure and hemolytic anemia.3,4 The incidence of PVL following SAVR is reported to be 2%-10% in the aortic position and 7%-17% in the mitral position. Approximately 1%-5% of these patients have serious clinical consequences.1 The TAVR data show that there is an approximately 6.8% incidence of moderate or severe PVL following TAVR and that the presence of moderate or severe PVL is associated with worse clinical outcomes.5
Reoperation is associated with increased morbidity and is not always successful because of underlying tissue friability, inflammation, or calcification. Rihal et al6 described the management of PVL including redo surgery and the use of vascular plugs. Reed et al7 have also provided expert guidance in similar situations.
There are approximately 200 publications related to the treatment of PVL in either the aortic or mitral position.8 Percutaneous-based treatments typically involve using an Amplatzer vascular plug (AGA Medical), which is FDA approved for embolization of the venous or arterial vasculature. The use of the Amplatzer vascular plug for PVL is considered an off-label indication, and has provided mixed results.9 Transcutaneous closure of PVL is demanding, and the expertise may not be readily available in many medical centers performing TAVR.10 In this article, we explore the feasibility of using a transcatheter valve-in-valve (VinV) approach to treat a significant PVL in the aortic position, following both surgical bioprosthetic valve and TAVR. The placement of a second transcatheter valve has previously been described to treat malpositioning of a first TAVR valve in the acute setting, but the use of VinV-TAVR to treat late PVL has not been widely regarded as an option to date.11 Shivaraju et al12 reported the success of implanting a Sapien S3 valve (Edwards Lifesciences) in a CoreValve (Medtronic) for significant PVL. We review and report four cases where VinV-TAVR successfully eliminated significant PVLs in the aortic position. We describe the first case and summarize the other three in Table 1.
First TAVR. Our representative case was a 76-year-old male with a past medical history significant for non-obstructive coronary artery disease, insulin-dependent diabetes mellitus, end-stage renal disease on hemodialysis, hypertension, chronic obstructive pulmonary disease, and severe aortic stenosis with New York Heart Association (NYHA) class III symptoms. The patient was initially seen in March 2015 at our valve clinic. Physical examination was significant for clinical signs of congestive heart failure (NYHA class III). His lung auscultation revealed bibasilar crackles and cardiac auscultation showed a late peaking systolic ejection murmur grade 4/6 at the apex and left intercostal space. His pre-TAVR echocardiogram showed a heavily calcified aortic valve (Figure 1) and a mean gradient of 40 mm Hg, with a peak velocity of 4.06 m/s. Mild aortic regurgitation was noted. The heart team determined that he was a high-risk surgical candidate with an STS score of 19%. The patient underwent a TAVR workup at our institution including a cardiac computed tomography, which showed an aortic annulus area of 841 mm2 and a perimeter of 104 mm. He was 193 cm tall and weighed 134 kg, with a body mass index of 35 kg/m2. He had adequate access for a transfemoral approach.
The patient’s aortic annular measurements (Figures 2A and 2B) were clearly beyond the approved available size for either a Sapien THV or a Medtronic CoreValve (Sapien S3 and Medtronic Evolut-R were not yet approved at the time). A thorough discussion was carried out among the heart team members and also with the patient and his family. The family was fully advised regarding his limited options and finally decided to proceed with TAVR using a 31 mm CoreValve via transfemoral route. There was a clear understanding that there could be some degree of PVL following placement of the transcatheter valve.
A standard TAVR procedure was performed. The patient was placed under general anesthesia and a transesophageal echocardiogram (TEE) was used to guide the procedure. A 31 mm CoreValve was placed with a depth of 6 mm. Following deployment of the valve, a moderate PVL was noted on TEE. Postdilation was carried out using rapid pacing and a 28 mm Z-med balloon (Braun Interventional Systems) without a significant change in the PVL. The patient remained hemodynamically stable without a significant pulse pressure present. It was felt that due to the presence of a large annulus, placing another CoreValve with a VinV configuration would not reduce the PVL. The procedure was concluded with a plan to clinically reevaluate the patient over the next several months. The patient was discharged home on day 4 post operation. Over the next 2 months, the patient’s functional capacity slowly declined. On his follow-up visits, the patient stated that he never had any relief of his symptoms following his TAVR procedure. He was admitted 1 week prior to his second TAVR procedure with acute decompensated heart failure for which he was treated medically. His repeat TEE showed severe central aortic valve regurgitation and a moderate PVL with pressure half time (Figure 3). The patient also had moderate mitral valve regurgitation (Figure 4).
His case was again discussed at our heart team meeting. It was decided to perform a repeat TAVR procedure using a VinV approach with a 29 mm Sapien XT valve. The goal of this second TAVR procedure was to eliminate the central aortic valve regurgitation and reduce the PVL.
Second TAVR. As with the first TAVR procedure, the second TAVR procedure was completed under general anesthesia via transfemoral route. TEE was also used to guide the procedure. No dilation of the first TAVR valve was planned. The Sapien XT valve was prepared as usual but with an additional 2 cc of volume in the balloon. The CoreValve was crossed without difficulty and a properly curved extra-stiff Amplatzer wire was advanced into the left ventricle. The Sapien XT valve was prepared and advanced across the CoreValve without difficulty. The positioning was set at a level of 2-4 mm from the lower edge of the CoreValve. With proper positioning, rapid pacing was initiated. At a systolic blood pressure <50 mm Hg and pulse pressure <10 mm Hg, the Sapien XT valve was deployed slowly and remained in the targeted position (Figure 5). TEE immediately post TAVR showed resolution of the central aortic regurgitation. In addition, there was near complete resolution of the PVL (Figure 6). A follow-up aortogram demonstrated that the coronary arteries were widely patent, as well as a significant reduction in his mitral valve regurgitation (Figure 7).
The patient tolerated the procedure well. On postoperative day 1, he subjectively felt much better. The patient was discharged on postoperative day 3 with significant resolution of his symptoms. At 3-month follow-up exam, he continued to be clinically asymptomatic. Figures 8 and 9 detail the measurements of the native aortic annulus and the corresponding sizes for the Edwards Sapien and Medtronic CoreValve transcatheter heart valves (THVs).
PVL is a rare but sometimes serious complication of both SAVR and TAVR. Management of patients with a significant PVL following valve replacement is complex and there is no standardized treatment algorithm for these patients. Medical therapy, repeat operation, and the use of vascular plugs have been described as potential treatment options for PVL. Herein, we present the option of VinV-TAVR as a potential treatment strategy for some patients with PVL following valve replacement.
Medical management. The medical management of PVL is usually palliative, with the goal of relieving symptoms of heart failure. Blood transfusion is sometimes required for patients with significant hemolytic anemia. Medical management, however, does not address the fundamental problem of the PVL.
Repeat surgery. Reports indicate that the mortality rate is high for patients undergoing repeat surgical repair.13 The failure rate has been reported to range from 12%-35%.14 The surgical techniques used are variable, depending on the anatomy, the location of the leak(s), and the patient’s overall condition. Nevertheless, repeat surgery remains the gold standard for the treatment of significant PVL. Taramasso et al15 described the percutaneous closure of a PVL in the mitral position via transapical approach and reported that it is as effective as repeat surgery, but is associated with a lower in-hospital mortality rate.
Percutaneous transcatheter closure using vascular plugs. The use of vascular plugs for the closure of PVL has been widely reported.16,17 There are approximately 200 publications related to the treatment of PVL using a percutaneous approach to deliver vascular plugs. Rihal et al6 retrospectively reviewed 126 patients who underwent catheter-based treatment of symptomatic prosthetic paravalvular regurgitation. Patients were contacted for symptoms, clinical events, and vital status. They reported that the 3-year estimated survival rate was 64.3% (95% confidence interval, 52.1%-76.8%). Mortality occurred due to cardiac, non-cardiac, and unknown causes in 9.5%, 7.1%, and 5.6% of patients, respectively. Among survivors, 72% of patients who had presented with heart failure were free of severe symptoms and did not require subsequent cardiac surgery. The severity of residual regurgitation was not related to overall survival, but was an important determinant of other clinical events. For those with no, mild, or moderate/severe residual regurgitation, the 3-year freedom from death or subsequent need for cardiac surgery was 63.3%, 58.3%, and 30.3%, respectively (P=.01). The authors concluded that the percutaneous repair of paravalvular prosthetic valve regurgitation could lead to durable symptom relief in selected patients. The mortality rate remains significant, however, in symptomatic patients with paravalvular prosthetic valve regurgitation. The long-term clinical efficacy of percutaneous transcatheter closure using vascular plugs is highly dependent on the degree of residual regurgitation following placement of the vascular plugs. Kliger et al18 elegantly reviewed the diagnosis and treatment of bioprosthetic PVL, including an extensive review of the use of vascular plugs, particularly Amplatzer vascular plugs. The procedure is complex and demanding and requires a large inventory of equipment. There is currently no device specifically developed for PVL closure, and the use of available devices remains off-label.
VinV-TAVR for Bioprosthetic PVL. The use of VinV-TAVR has been reported and is currently approved by the Food and Drug Administration with the use of the CoreValve or the Sapien XT valve. The use of a Sapien valve inside a CoreValve has been reported, as has the placement of a CoreValve within a Sapien valve.- VinV-TAVR usually involves placement of a THV inside a prior surgical bioprosthetic implantation. The selection of the optimal valve for a VinV procedure is guided by the size and type of the prior bioprosthetic valve. VinV-TAVR where the second THV is placed inside a previously placed THV is less common, unless it is in the acute setting where there is malposition of the first THV valve.
To the best of our knowledge, the case detailed above is the first reported case using a VinV-TAVR procedure to treat a significant PVL in the setting of a large aortic annulus following a prior TAVR procedure. There are only a few reports that discuss how to manage patients with a large aortic annulus who are not surgical candidates. Anecdotal reports have recommended the use of the Medtronic CoreValve beyond the recommended sizing guidelines with varying degrees of success.19,20 In this report, we describe the successful transcatheter placement of a Sapien XT valve within a previously placed CoreValve for the treatment of a PVL in a patient with a large aortic annulus who is not a candidate for open SAVR.
The placement of a second THV within a prior THV can close a PVL because the second valve provides the additional layers of metal and tissue necessary to seal the leak. The correct technical placement of the second THV should reliably eliminate the central aortic regurgitation. The significant reduction in the degree of mitral regurgitation is most likely due to the reduction in central and paravalvular aortic regurgitation. It is not clear if the transcatheter placement of a CoreValve within a previously placed Sapien valve would provide a similar outcome, due to the different properties of each valve.
Overexpanding the Sapien S3 valve. A recent Letter to the Editor by Shivaraju et al20 elegantly described the feasibility of overexpanding the Sapien S3 up to a circumference of 740 mm2. The letter describes how the 23 mm, 26 mm, and 29 mm Sapien S3 valves were overexpanded to 453 mm2, 593 mm2, and 742 mm2, respectively (~10% oversize from the recommended sizing guidelines) without compromising leaflet function. They reported the relative safety of this maneuver in a patient with a larger annulus. The major limitation to oversizing in this setting is the possibility of bursting the balloon used to expand the valve. It is generally recommended that not more than 4 mL of volume should be added to the balloon. We have experience with adding up to 5 mL of volume to the balloon without having the balloon burst with complete inflation. This approach may also be an option in treating selected patients with a large aortic annulus. This is possible because of the geometry of the Sapien S3 stent strut design.21 It is not clear if this approach can be applied to a self-expanding valve due to the recoil memory property of the valve not allowing the predetermined limits for maximum expansion to be exceeded.
Percutaneous PVL closure using vascular plugs may be the only option for the closure of PVLs in patients with mechanical heart valves who are not candidates for repeat surgery. The use of vascular plugs has been described for treatment of PVL in prior surgically placed bioprosthetic valves. We have found that performing a VinV-TAVR procedure is less technically demanding than the placement of vascular plugs. In properly selected patients, a VinV approach may be a viable alternative to the placement of vascular plugs for the closure of PVLs in patients with previously surgically placed bioprosthetic valves. The mechanism in our case is likely sealing of the subvalvular outflow tract with the skirt of the CoreValve.
Table 2 summarizes the different approaches of medical management, repeat surgery, transcatheter vascular plug, and VinV-TAVR for the treatment of PVL.
PVL is an uncommon complication following SAVR and TAVR. The treatments for significant PVL are not standardized and repeat operation remains the standard of care for surgically appropriate patients. For patients who are not candidates for repeat surgery, treatment has ranged from medical treatment to percutaneous closure using vascular plugs. Percutaneous closure using vascular plugs is a complex and demanding procedure with variable results and may require the placement of multiple plugs.16-18 In properly selected patients with a PVL following placement of a bioprosthetic aortic valve, placement of a transcatheter aortic valve-in-valve may be a viable treatment option.
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From the 1Division of Cardiovascular Medicine; and 2Division of Cardiothoracic Surgery, University of Utah School of Medicine, Salt Lake City, Utah.
Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. The authors report no conflict of interest regarding the content herein.
Manuscript submitted August 1, 2016, final acceptance given August 9, 2016.
Address for correspondence: Anwar Tandar, MD, Division of Cardiovascular Medicine, University of Utah School of Medicine, 30 North 1900 East, Rm 4A100, Salt Lake City, UT 84132. Email: email@example.com