Catheterization and Cardiovascular Interventions 85:665–666 (2015)
Editorial Comment Paravalvular Leak Closure After Transcatheter Aortic Valve Replacement: Technical Challenges and Clinical Utility Ted Feldman,* MD, FESC, FACC MSCAI Cardiology Division, NorthShore University HealthSystem Evanston, Illinois
Key Points
Post TAVR PVL closure with low profile vascular plugs is feasible, even for the relatively longer frame of the CoreValve device. Device closure for PVL may be successful even after post-dilatation and valve-in-valve have failed. The low profile of the AVP4, which can pass through 4-5F diagnostic catheters, makes this approach practical.
Arri et al. [1] report the use of low-profile vascular plugs for closure of symptomatic paravalvular leaks (PVL) after transcatheter aortic valve replacement (TAVR) with the self-expanding CoreValve device. This report is important because it confirms the feasibility of delivery of a vascular plug for the CoreValve [2]. While this approach has been used for SAPIEN valve PVL [3], the longer frame of the CoreValve presents a greater difficulty. What indication should drive the decision to treat PVL? The assessment of PVL severity for patient selection for this kind of procedure is challenging. Echo, hemodynamic, and angiographic methods are all employed, and all have important limitations. As the author’s note, ultimately symptoms and persistent heart failure after TAVR drive therapy for PVL. Once a decision is made to pursue device closure, several technical considerations are critical. The challenges of treating PVL after TAVR include deciding among post dilatation, valve-in-valve, or plug implantation as therapy options. There is a paradox for postdilatation, since further expansion of the stent frame may both cause central aortic insufficiency, and diminish the chances for paravalvular plug delivery. The space between C 2015 Wiley Periodicals, Inc. V
the outside of the stent frame and the calcified, deformed native aortic leaflet tissue is obviously highly irregular, and seems in concept difficult to cross under any circumstances. The length of the CoreValve stent makes traversing the space even more challenging. One of the challenges of performing these procedures is identifying and translating the echocardiographic location of the leak to the fluoroscopic anatomy. One of the most useful methods is to recognize from the echocardiographic assessment what structures are adjacent to the leak. The left main and right coronary ostia, the course of the circumflex under the left atrial appendage, and the anterior leaflet attachment of the mitral valve are among the most useful anatomic landmarks. 3D echo during the procedure is helpful for guidance. The use of left Amplatz catheters to probe the frame on the left hemisphere of the stent frame, and multipurpose or right Judkins catheters or the right coronary hemisphere stent frame work well. Using 5-French coronary catheters is feasible, since after a wire has been directed through the leak, these catheters can be manipulated directly between the stent frame and the native leaflets, and ultimately the vascular plug delivered through this catheter. I have found that the AVP4 traverses the curves of Amplatz and right Judkins catheters easily. As noted in this report, exchanging for a 4F glide catheter is sometimes necessary. It is notable particularly that because these devices can be delivered through a low profile catheter, one of the cases in the series was performed via a radial approach. After passing a wire through the leak it is necessary to be sure the path of the wire is entirely outside the stent frame. It can be difficult to find a fluoroscopic view to demonstrate this. There is clear potential for failure to cross these leaks. The large Conflict of interest: Consultant and grant support: Abbott, BSC, Edwards. *Correspondence to: Ted Feldman, MD, FESC FACC MSCAI, Evanston Hospital, Cardiology Division-Walgreen Building 3rd Floor, 2650 Ridge Ave., Evanston, IL 60201, (847) 570-2250, Fax: (847) 570-1865, Email: [email protected] Contract grant sponsor: Abbott, BSC, Edwards. Received 7 January 2015; Revision accepted 8 January 2015 DOI: 10.1002/ccd.25835 Published online 19 February 2015 in Wiley Online Library (wileyonlinelibrary.com)
666
Feldman
Fig. 1. The aortic regurgitation index (ARI) before and after placement of an AVP for PVL. On the left, the baseline ARI was 26. On the right, after reduction of the PVL from severe to trace, the ARI has increased to 33. From Feldman et al., Catheter Cardiovasc Interv, 2014, 83, 280–288.
nodules of calcium that are often responsible for the leak may be impediments to passing a wire into the left ventricle. PVL closure can have a dramatic impact on both hemodynamics and symptoms (Fig. 1). One patient in our practice had been stuck on a ventilator for several days following TAVR, and was successfully extubated only a few hours after PVL closure. In this report, a mean time from the TAVR procedure to PVL closure was several months. In our practice, we have closed leaks around SAPIEN valves at the time of implant, and within the first several days after TAVR. A waiting period is thus not critical. The delivery of these low profile plugs is simple enough that if a wire crosses a leak during a diagnostic evaluation, a plug may be delivered. As these authors note, waiting a couple of weeks in one case resulted in a more difficult procedure. When temporizing is necessary, ventricular pacing at rates of 90–110 bpm to shorten diastole may be useful [4]. Next generation devices such as the Edwards S3 and Boston Scientific Lotus valve will diminish the frequency of PVL. In the meantime, there are a large number of patients living with first generation TAVR devices, many with significant aortic insufficiency. The
potential for percutaneous closure with vascular plugs remains important. A relatively small number of closure procedures have been reported. The frequency of PVL is large in terms of patient numbers. The effectiveness of postdilatation and valve-in-valve approaches for PVL seems variable at best. PVL closure with plugs should probably occupy a larger role in the treatment of this vexing problem.
REFERENCES 1. Arri SS, Poliacikova P, Hildick-Smith D. Percutaneous paravalvular leak closure for symptomatic aortic regurgitation after CoreValve transcatheter aortic valve implantation. Catheter Cardiovasc Interv 2015;85:657–664. 2. Gafoor S, Franke J, Piayda K, Lam S, Bertog S, Vaskelyte L, Hofmann I, Sievert H. Paravalvular leak closure after transcatheter aortic valve replacement with a self-expanding prosthesis. Catheter Cardiovasc Interv. 2014;84:147–154. doi: 10.1002/ ccd.25176. 3. Feldman T, Salinger MH, Levisay JP, Smart S. Low profile vascular plugs for paravalvular leaks after TAVR. Catheter Cardiovasc Intervent 2014;83:280–288.doi: 10.1002/ccd.25202. 4. Ali O, Salinger MH, Levisay JP, Feldman T. High pacing rates for management of aortic insufficiency after balloon aortic valvuloplasty or transcatheter aortic valve replacement. Catheter Cardiovasc Intervent 2014;83:162–168.
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
Editorial Comment Paravalvular Leak Closure After Transcatheter Aortic Valve Replacement: Technical Challenges and Clinical Utility Ted Feldman,* MD, FESC, FACC MSCAI Cardiology Division, NorthShore University HealthSystem Evanston, Illinois
Key Points
Post TAVR PVL closure with low profile vascular plugs is feasible, even for the relatively longer frame of the CoreValve device. Device closure for PVL may be successful even after post-dilatation and valve-in-valve have failed. The low profile of the AVP4, which can pass through 4-5F diagnostic catheters, makes this approach practical.
Arri et al. [1] report the use of low-profile vascular plugs for closure of symptomatic paravalvular leaks (PVL) after transcatheter aortic valve replacement (TAVR) with the self-expanding CoreValve device. This report is important because it confirms the feasibility of delivery of a vascular plug for the CoreValve [2]. While this approach has been used for SAPIEN valve PVL [3], the longer frame of the CoreValve presents a greater difficulty. What indication should drive the decision to treat PVL? The assessment of PVL severity for patient selection for this kind of procedure is challenging. Echo, hemodynamic, and angiographic methods are all employed, and all have important limitations. As the author’s note, ultimately symptoms and persistent heart failure after TAVR drive therapy for PVL. Once a decision is made to pursue device closure, several technical considerations are critical. The challenges of treating PVL after TAVR include deciding among post dilatation, valve-in-valve, or plug implantation as therapy options. There is a paradox for postdilatation, since further expansion of the stent frame may both cause central aortic insufficiency, and diminish the chances for paravalvular plug delivery. The space between C 2015 Wiley Periodicals, Inc. V
the outside of the stent frame and the calcified, deformed native aortic leaflet tissue is obviously highly irregular, and seems in concept difficult to cross under any circumstances. The length of the CoreValve stent makes traversing the space even more challenging. One of the challenges of performing these procedures is identifying and translating the echocardiographic location of the leak to the fluoroscopic anatomy. One of the most useful methods is to recognize from the echocardiographic assessment what structures are adjacent to the leak. The left main and right coronary ostia, the course of the circumflex under the left atrial appendage, and the anterior leaflet attachment of the mitral valve are among the most useful anatomic landmarks. 3D echo during the procedure is helpful for guidance. The use of left Amplatz catheters to probe the frame on the left hemisphere of the stent frame, and multipurpose or right Judkins catheters or the right coronary hemisphere stent frame work well. Using 5-French coronary catheters is feasible, since after a wire has been directed through the leak, these catheters can be manipulated directly between the stent frame and the native leaflets, and ultimately the vascular plug delivered through this catheter. I have found that the AVP4 traverses the curves of Amplatz and right Judkins catheters easily. As noted in this report, exchanging for a 4F glide catheter is sometimes necessary. It is notable particularly that because these devices can be delivered through a low profile catheter, one of the cases in the series was performed via a radial approach. After passing a wire through the leak it is necessary to be sure the path of the wire is entirely outside the stent frame. It can be difficult to find a fluoroscopic view to demonstrate this. There is clear potential for failure to cross these leaks. The large Conflict of interest: Consultant and grant support: Abbott, BSC, Edwards. *Correspondence to: Ted Feldman, MD, FESC FACC MSCAI, Evanston Hospital, Cardiology Division-Walgreen Building 3rd Floor, 2650 Ridge Ave., Evanston, IL 60201, (847) 570-2250, Fax: (847) 570-1865, Email: [email protected] Contract grant sponsor: Abbott, BSC, Edwards. Received 7 January 2015; Revision accepted 8 January 2015 DOI: 10.1002/ccd.25835 Published online 19 February 2015 in Wiley Online Library (wileyonlinelibrary.com)
666
Feldman
Fig. 1. The aortic regurgitation index (ARI) before and after placement of an AVP for PVL. On the left, the baseline ARI was 26. On the right, after reduction of the PVL from severe to trace, the ARI has increased to 33. From Feldman et al., Catheter Cardiovasc Interv, 2014, 83, 280–288.
nodules of calcium that are often responsible for the leak may be impediments to passing a wire into the left ventricle. PVL closure can have a dramatic impact on both hemodynamics and symptoms (Fig. 1). One patient in our practice had been stuck on a ventilator for several days following TAVR, and was successfully extubated only a few hours after PVL closure. In this report, a mean time from the TAVR procedure to PVL closure was several months. In our practice, we have closed leaks around SAPIEN valves at the time of implant, and within the first several days after TAVR. A waiting period is thus not critical. The delivery of these low profile plugs is simple enough that if a wire crosses a leak during a diagnostic evaluation, a plug may be delivered. As these authors note, waiting a couple of weeks in one case resulted in a more difficult procedure. When temporizing is necessary, ventricular pacing at rates of 90–110 bpm to shorten diastole may be useful [4]. Next generation devices such as the Edwards S3 and Boston Scientific Lotus valve will diminish the frequency of PVL. In the meantime, there are a large number of patients living with first generation TAVR devices, many with significant aortic insufficiency. The
potential for percutaneous closure with vascular plugs remains important. A relatively small number of closure procedures have been reported. The frequency of PVL is large in terms of patient numbers. The effectiveness of postdilatation and valve-in-valve approaches for PVL seems variable at best. PVL closure with plugs should probably occupy a larger role in the treatment of this vexing problem.
REFERENCES 1. Arri SS, Poliacikova P, Hildick-Smith D. Percutaneous paravalvular leak closure for symptomatic aortic regurgitation after CoreValve transcatheter aortic valve implantation. Catheter Cardiovasc Interv 2015;85:657–664. 2. Gafoor S, Franke J, Piayda K, Lam S, Bertog S, Vaskelyte L, Hofmann I, Sievert H. Paravalvular leak closure after transcatheter aortic valve replacement with a self-expanding prosthesis. Catheter Cardiovasc Interv. 2014;84:147–154. doi: 10.1002/ ccd.25176. 3. Feldman T, Salinger MH, Levisay JP, Smart S. Low profile vascular plugs for paravalvular leaks after TAVR. Catheter Cardiovasc Intervent 2014;83:280–288.doi: 10.1002/ccd.25202. 4. Ali O, Salinger MH, Levisay JP, Feldman T. High pacing rates for management of aortic insufficiency after balloon aortic valvuloplasty or transcatheter aortic valve replacement. Catheter Cardiovasc Intervent 2014;83:162–168.
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
