Corresponding Author
Key Words: complication, paravalvular leak, transcatheter aortic replacement
Transcatheter aortic valve replacement (TAVR) has become an effective and alternative therapy for patients with symptomatic severe aortic stenosis who are at low, intermediate, or high risk or have any contraindication for surgical aortic valve replacement (1, 2, 3, 4, 5). Paravalvular leak (PVL) after TAVR is, since early-generation devices, a well-known complication with balloon-expandable and self-expandable prostheses, and it has been associated with poor prognosis and short- and long-term mortality (2,6).
In this issue of JACC: Case Reports, Conte et al. (7) present an interesting clinical case series of PVL closure after TAVR. They performed successfully these challenging procedures using different materials and strategies when difficulties appeared.
In the first case, mild PVL was described after TAVR with Evolut R (Medtronic, Minneapolis, Minnesota), with worsening during follow-up. This is uncommon in a self-expandable transcatheter valve, in which reduction of previous leak is expected in the first year. The decision was made to perform PVL closure, which is the best option when incomplete adherence to the annulus is observed owing to a bulky calcified nodule and post-implant balloon dilatation cannot be performed or has not been optimal. Using a retrograde approach, the Amplatz Left 1 catheter was crossed through the upper cells of the valve frame struts, a maneuver for better device deliverability when treating PVL in a self-expandable transcatheter valve. But when the defect was crossed with a wire into the left ventricle (LV), they failed to advance the delivery sheath. This problem can happen when the device chosen for a large defect is the Amplatzer Vascular Plug III (AVP III) (Abbott Vascular, Santa Clara, California) because it requires a larger delivery sheath and extra support for its deployment. From the LV, they managed to advance the wire back through the center of the TAVR until the ascending aorta and then, with this extra support, release a 12 × 5 mm AVP III.
In the second case, a SAPIEN 3 (Edwards Lifesciences, Irvine, California) balloon-expandable transcatheter valve was used with excellent result and just trivial PVL. However, the patient deteriorated during follow-up, and a moderate-to-severe PVL was observed. Once again, the 6-F delivery sheath could not advance, and in this case, they used an extra-stiff guidewire to obtain additional support and deploy a 14 × 5 mm AVP III.
In both cases, the need for more support to advance a 6-F delivery sheath to deploy a large AVP III device required different methods to obtain it. There are no specific devices developed for PVL closure after TAVR and several have been used (AVP II, AVP III, AVP IV, ventricular septal defect occluder) (8). Owing to its low profile, AVP IV is the most frequently used device, allowing the use of just 4-F to 5-F diagnostic catheters (9).
Sometimes, an option is to perform first a balloon dilatation to reduce the paravalvular leak, and then use low-profile vascular plugs. Also, 2 small vascular plugs could be released through a 5-F catheter in the same procedure (10). Occasionally, before the first device release, a safety wire can be left in the LV, facilitating a possible second device deployment without crossing again the defect.
If even more support is needed, the arterioarterial rail technique can be performed. When the wire is in the LV, it is advanced back through the center of the TAVR and then snared in the ascending aorta and externalized through another arterial access, creating a supportive rail to retrogradely advance the delivery sheath. If that fails, an antegrade approach using the same arterioarterial rail has been described (11). An arteriovenous rail could also be created when wire is advanced from LV to the left atrium, and then snared through a transseptal puncture and externalized.
The safety and feasibility of percutaneous PVL closure procedures have been confirmed previously in surgical patients with PVL in mechanical and biological prostheses (12).
It is a complex procedure with not only high procedural success, but also serious periprocedural complications, requiring optimal patient selection, cardiac imaging intraprocedural guidance, and expert operators (8). However, there is still a need for devices specifically intended to treat PVL.
Other percutaneous therapies for different PVL mechanisms (13) are the implantation of a second transcatheter valve when malposition (low or high with respect to the aortic annulus) and the transcatheter valve repositioning when is too low, pulling up carefully to a higher position after snaring 1 or 2 of the valve frame loops, with better alignment and control from radial access than from femoral access.
We congratulate the authors for presenting these challenging cases, as PVL is a hot topic in TAVR, and this special issue of JACC: Case Reports gave a great opportunity to review and know how to prevent and manage it.
TAVR is expanding to new indications, with lower-risk and younger patients on the horizon. New and ongoing trials are also studying TAVR in asymptomatic severe aortic stenosis patients (EARLY TAVR [Evaluation of Transcatheter Aortic Valve Replacement Compared to SurveilLance for Patients With AsYmptomatic Severe Aortic Stenosis] trial; NCT03042104) and moderate aortic stenosis patients with heart failure (TAVR UNLOAD [Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure] trial; NCT02661451). To face this challenge, TAVR must solve some questions regarding valve durability, reduction of complications associated with the procedure (paravalvular leak, permanent pacemaker implantation, vascular complications, and ischemic stroke), and the possibility of following procedures in the future (TAVR in TAVR, access to coronary arteries for percutaneous angioplasty).
Therefore, newer transcatheter devices must minimize procedural complications such as paravalvular leak and provide maximum safety and efficacy. Only then will there be no smoke on the horizon for TAVR.
Footnotes
Dr. Moreno-Samos has reported that he has no relationships relevant to the contents of this paper to disclose. Dr. Cruz-Gonzalez has served as a proctor for Abbott Vascular. John W. Hirshfeld, Jr., MD, served as Guest Associate Editor for this paper.
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