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Heart, Lung and Circulation (2015) xx, 1–4 1443-9506/04/$36.00 http://dx.doi.org/10.1016/j.hlc.2015.04.163
Paravalvular Leak Leading to Severe Aortic Valve Regurgitation after TAVI: Percutaneous Closure Strategy Marco Luciano Rossi, MD *, Guido Belli, MD, Paolo Pagnotta, MD, Carla Lucarelli, MD, Patrizia Presbitero, MD Department of Invasive Cardiology, Humanitas Research Hospital, Rozzano (Milan), Italy Received 24 November 2014; received in revised form 13 March 2015; accepted 14 April 2015; online published-ahead-of-print xxx
Regurgitation due to a paravalvular leak (PVL) is a complication that may affect patients undergoing surgical mechanical or bioprosthetic heart valve replacement. PVL can also occur after transcatheter aortic valve implantation (TAVI) in patients with severe aortic stenosis and is associated with significantly worse outcomes. We report a case in which different closure strategies and devices were attempted and required to percutaneously close a severe PVL after TAVI in a patient with prohibitive surgical risk. Keywords
Paravalular leak (PVL) Transcatheter aortic valve implantation (TAVI) Severe aortic regurgitation Percutaneous closure devices Percutaneous valve-in-valve placement
Regurgitation due to a paravalvular leak (PVL) is a complication that may affect from 2 to 17% of patients undergoing surgical mechanical or bioprosthetic heart valve replacement [1,2]. PVL can also occur after transcatheter aortic valve implantation (TAVI) in patients with severe aortic stenosis and is associated with significantly worse outcomes [3,4]. PVL may occur with severe valvular calcification or after infectious endocarditis [4]. The ever-increasing number of post-TAVI patients are usually elderly and at prohibitive surgical risk: a significant PVL leading to severe aortic regurgitation and congestive heart failure represents a considerable management challenge. In order to try and mechanically solve the problem without surgical (re)intervention, several occlusion devices, otherwise used for different indications in interventional cardiology, may be considered for percutaneous insertion across the PVL to try and seal the regurgitant flow. Small series of high-risk patients treated with such devices after surgical aortic or mitral valve replacement, but none after TAVI, have been published [5]. Others have advocated the use of percutaneous valve-in-valve placement [4]. We report a case in which different closure strategies and
devices were attempted and required to percutaneously close a severe PVL after TAVI. An 82 year-old woman had successful TAVI with an Edward Sapien XT 23 mm valve for severe aortic stenosis in 2011. She had an uncomplicated course for three years, with good functional status (NYHA class I-II). Her past medical history included HCV hepatitis, a permanent pace-maker implantation due to advanced AV block and acute myocardial infarction (with normal coronary arteries, probable Tako-tsubo cardiomyopathy) during surgical resection of gastrointestinal angiodysplasias. She had poor left ventricular systolic function with an ejection fraction (LVEF) of 30% and a high logistic Euroscore of 32. In October 2013 she was admitted to the hospital for progressive dyspnoea and peripheral oedema (NYHA class III). She reported a fever for 10 days, two months before admission. A trans-thoracic echocardiogram showed an LVEF of 25% and severe aortic regurgitation due to two major paraprosthetic leaks (Fig. 1 A, B), with a diagnosis of suspected remote endocarditis. After multidisciplinary evaluation, a decision was made to try to close the PVLs percutaneously, because
*Corresponding author at: Department of Invasive Cardiology, Humanitas Research Hospital, Rozzano (Milan), Italy. Via Manzoni 56, 20089 Rozzano (Milan), Italy. Tel.: +39-(0)2-82244626; fax: +39-(0)2-82243690, Email: [email protected] © 2015 Published by Elsevier Inc on behalf of Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) and the Cardiac Society of Australia and New Zealand (CSANZ).
Please cite this article in press as: Rossi ML, et al. Paravalvular Leak Leading to Severe Aortic Valve Regurgitation after TAVI: Percutaneous Closure Strategy. Heart, Lung and Circulation (2015), http://dx.doi.org/10.1016/j.hlc.2015.04.163
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Figure 1 A) Trans-thoracic echocardiographic image of severe aortic regurgitation due to 2 major paraprosthetic leaks. B) Angiographic image showing severe aortic regurgitation.
the risk of surgical intervention was deemed unacceptably high. Given the specific anatomical characteristics of the observed leaks, we initially had planned to use an occluder Vascular Plug II. This is a cylindrical-shaped nitinol mesh device available in various sizes that range from 3 to 22 mm in length and from 6 to 18 mm in diameter. This device can mechanically adjust to variable landing zones, and provide enhanced performance in high flow situations. The occluder is released by uncapping the delivery system from the distal to the proximal rim, allowing the nitinol mesh to recover its ‘‘memory’’ shape at blood temperature.
Implantation was performed through the right femoral artery, with a 6 French sheath, under general anaesthesia, with fluoroscopic and transoesophageal echocardiographic (TEE) guidance. After advancement of a 6-F multipurpose guiding catheter in proximity to the PVL canal, a guidewire was passed through the canal and then the guiding catheter was advanced over the wire through the PVL. Partial opening and deployment was obtained (Fig. 2 A,B). However, it was immediately observed that the plug, because of its size, would interfere with normal prosthetic leaflet motion, so it was recaptured and removed before final release. A decision was then made to try and deploy a 4 mm-Amplatzer Septal
Figure 2 A) Fluoroscopic image showing partial opening and deployment of vascular plug 2 through the paravalvular leak. B) Vascular Plug 2 completely opened. C) Fluoroscopic image of the 4 mm-Amplatzer Septal Occluder just delivered through the paravalvular leak. D) Transoesophageal echocardiography image showing persistent moderately severe aortic regurgitation after delivery of an Amplatzer Septal Occluder.
Please cite this article in press as: Rossi ML, et al. Paravalvular Leak Leading to Severe Aortic Valve Regurgitation after TAVI: Percutaneous Closure Strategy. Heart, Lung and Circulation (2015), http://dx.doi.org/10.1016/j.hlc.2015.04.163
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Occluder. The occluder was advanced within the same delivery sheath, and the distal disc was opened across the paravalvular leak. The sheath was subsequently pulled back and the second disc opened. After achieving a stable device position, confirmed by fluoroscopy, TEE and the so-called ‘‘push-and-pull’’ manoeuver, the device was released (Fig. 2 C). After delivery, however, there seemed to be residual severe aortic regurgitation through the leak by TEE. We had set a general goal for the procedure to decrease the degree of AR to at least grade moderate (Fig. 2 D). A second plug may have been deployed, but this did not seem a viable option because of the limited residual space between the prosthetic valve and surrounding tissues. At this point the procedure was terminated, the patient did reasonably well during hospitalisation and could be discharged on day 6. Only three months later however she was admitted again with acute pulmonary oedema. Echocardiography confirmed the persistence of severe aortic regurgitation. After further discussion within the Heart Team, it was decided to proceed with a percutaneous valve-in-valve implantation. TAVI was performed again via the right trans-femoral approach, and a 26 mm Medtronic Core Valve prosthesis was implanted (Fig. 3 A, B). Because of the size of the new prosthesis, an attempt was made to implant above the Edward Sapien XT 23, to avoid malfunction due to incomplete opening of the leaflets. Since TEE once more showed persistence of severe aortic insufficiency, a third valve, again a 26 mm Core Valve was implanted still a little higher
(Fig. 3 C). TEE showed only mild residual aortic regurgitation (Fig. 3 D), non-significant gradient. No significant pressure gradient across the valves was confirmed invasively. The patient was discharged on day 12. She has remained clinically stable, in NYHA class I-II, since then, with a repeat TTE at one year showing persistent normal aortic valvular function. In summary, treatment of PVL regurgitation in patients after TAVI remains one of the most challenging and difficult procedures in interventional cardiology. We learned several lessons from this most unusual case. Firstly, we showed how the initial approach was feasible as far as reaching through the opening and wiring the PVL. However, we speculate that in order to be successful new ‘‘custom-made’’ occlusion plugs should be developed and available, with sizing of the uppermost importance in order to avoid the observed interference with the movement of the valve leaflets. At present, dedicated devices are being clinically tested [1,5]. Three-dimensional TEE or CT, with 3D prints, may potentially aid in the future in the development of virtual ‘‘casts’’ of PVLs to guide selection of the proper customised sealing devices. Secondly, for similar reasons of lack of precise fitting through the defect, failure of the Amplatzer plug resulted in a degree of residual aortic insufficiency that, with hindsight, should have already been corrected during the first hospitalisation. We also learned that, in order to accurately seal a PVL with another valve, extremely precise positioning, at a height relative to the valvular plane that allows sealing with the covered circumferential portion of the new valve itself, while
Figure 3 A), B) Delivery of the first 26 mm Core-valve. C) Delivery of the second 26 mm Core-Valve. D) Transoesophageal echocardiography image showing mild residual aortic regurgitation after the valve-in-valve implantation.
Please cite this article in press as: Rossi ML, et al. Paravalvular Leak Leading to Severe Aortic Valve Regurgitation after TAVI: Percutaneous Closure Strategy. Heart, Lung and Circulation (2015), http://dx.doi.org/10.1016/j.hlc.2015.04.163
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allowing normal functioning and unrestricted opening of the new valve, is imperative to achieve a successful result. Finally, we acknowledge the significant excess costs that may be associated with such unforeseeable interventions for a unique but complex situation, that in our case can be estimated at around 40 to 50,000 euros.
References [1] Hammermeister K, Sethi GK, Henderson WG, Grover FL, Oprian C, Rahimtoola SH. Outcomes 15 years after valve replacement with a mechanical versus a bioprosthetic valve: final report of the Veterans Affairs randomized trial. J Am Coll Cardiol 2000;36:1152–8.
[2] Da´vila-Roma´n VG, Waggoner AD, Kennard ED, Holubkov R, Jamieson WR, Englberger L, et al. Artificial Valve Endocarditis Reduction Trial echocardiography study. Prevalence and severity of paravalvular regurgitation in the Artificial Valve Endocarditis Reduction Trial (AVERT) echocardiography study. J Am Coll Cardiol 2004;44:1467–72. [3] Moat NE, Ludman P, de Belder MA, Bridgewater B, Cunningham AD, Young CP, et al. Long-term outcomes after transcatheter aortic valve implantation in high-risk patients with severe aortic stenosis: the U.K. TAVI (United Kingdom Transcatheter Aortic Valve Implantation) Registry. J Am Coll Cardiol 2011;58:2130–8. [4] Ge´ne´reux P, Head SJ, Hahn R, Daneault B, Kodali S, Williams MR, et al. Paravalvular leak after transcatheter aortic valve replacement: the new Achilles’ heel? A comprehensive review of the literature. J Am Coll Cardiol 2013;61:1125–36. [5] Go¨ssl M, Rihal CS. Percutaneous treatment of aortic and mitral valve paravalvular regurgitation. Curr Cardiol Rep 2013;15:388.
Please cite this article in press as: Rossi ML, et al. Paravalvular Leak Leading to Severe Aortic Valve Regurgitation after TAVI: Percutaneous Closure Strategy. Heart, Lung and Circulation (2015), http://dx.doi.org/10.1016/j.hlc.2015.04.163
HOW-TO-DO-IT
Heart, Lung and Circulation (2015) xx, 1–4 1443-9506/04/$36.00 http://dx.doi.org/10.1016/j.hlc.2015.04.163
Paravalvular Leak Leading to Severe Aortic Valve Regurgitation after TAVI: Percutaneous Closure Strategy Marco Luciano Rossi, MD *, Guido Belli, MD, Paolo Pagnotta, MD, Carla Lucarelli, MD, Patrizia Presbitero, MD Department of Invasive Cardiology, Humanitas Research Hospital, Rozzano (Milan), Italy Received 24 November 2014; received in revised form 13 March 2015; accepted 14 April 2015; online published-ahead-of-print xxx
Regurgitation due to a paravalvular leak (PVL) is a complication that may affect patients undergoing surgical mechanical or bioprosthetic heart valve replacement. PVL can also occur after transcatheter aortic valve implantation (TAVI) in patients with severe aortic stenosis and is associated with significantly worse outcomes. We report a case in which different closure strategies and devices were attempted and required to percutaneously close a severe PVL after TAVI in a patient with prohibitive surgical risk. Keywords
Paravalular leak (PVL) Transcatheter aortic valve implantation (TAVI) Severe aortic regurgitation Percutaneous closure devices Percutaneous valve-in-valve placement
Regurgitation due to a paravalvular leak (PVL) is a complication that may affect from 2 to 17% of patients undergoing surgical mechanical or bioprosthetic heart valve replacement [1,2]. PVL can also occur after transcatheter aortic valve implantation (TAVI) in patients with severe aortic stenosis and is associated with significantly worse outcomes [3,4]. PVL may occur with severe valvular calcification or after infectious endocarditis [4]. The ever-increasing number of post-TAVI patients are usually elderly and at prohibitive surgical risk: a significant PVL leading to severe aortic regurgitation and congestive heart failure represents a considerable management challenge. In order to try and mechanically solve the problem without surgical (re)intervention, several occlusion devices, otherwise used for different indications in interventional cardiology, may be considered for percutaneous insertion across the PVL to try and seal the regurgitant flow. Small series of high-risk patients treated with such devices after surgical aortic or mitral valve replacement, but none after TAVI, have been published [5]. Others have advocated the use of percutaneous valve-in-valve placement [4]. We report a case in which different closure strategies and
devices were attempted and required to percutaneously close a severe PVL after TAVI. An 82 year-old woman had successful TAVI with an Edward Sapien XT 23 mm valve for severe aortic stenosis in 2011. She had an uncomplicated course for three years, with good functional status (NYHA class I-II). Her past medical history included HCV hepatitis, a permanent pace-maker implantation due to advanced AV block and acute myocardial infarction (with normal coronary arteries, probable Tako-tsubo cardiomyopathy) during surgical resection of gastrointestinal angiodysplasias. She had poor left ventricular systolic function with an ejection fraction (LVEF) of 30% and a high logistic Euroscore of 32. In October 2013 she was admitted to the hospital for progressive dyspnoea and peripheral oedema (NYHA class III). She reported a fever for 10 days, two months before admission. A trans-thoracic echocardiogram showed an LVEF of 25% and severe aortic regurgitation due to two major paraprosthetic leaks (Fig. 1 A, B), with a diagnosis of suspected remote endocarditis. After multidisciplinary evaluation, a decision was made to try to close the PVLs percutaneously, because
*Corresponding author at: Department of Invasive Cardiology, Humanitas Research Hospital, Rozzano (Milan), Italy. Via Manzoni 56, 20089 Rozzano (Milan), Italy. Tel.: +39-(0)2-82244626; fax: +39-(0)2-82243690, Email: [email protected] © 2015 Published by Elsevier Inc on behalf of Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) and the Cardiac Society of Australia and New Zealand (CSANZ).
Please cite this article in press as: Rossi ML, et al. Paravalvular Leak Leading to Severe Aortic Valve Regurgitation after TAVI: Percutaneous Closure Strategy. Heart, Lung and Circulation (2015), http://dx.doi.org/10.1016/j.hlc.2015.04.163
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Figure 1 A) Trans-thoracic echocardiographic image of severe aortic regurgitation due to 2 major paraprosthetic leaks. B) Angiographic image showing severe aortic regurgitation.
the risk of surgical intervention was deemed unacceptably high. Given the specific anatomical characteristics of the observed leaks, we initially had planned to use an occluder Vascular Plug II. This is a cylindrical-shaped nitinol mesh device available in various sizes that range from 3 to 22 mm in length and from 6 to 18 mm in diameter. This device can mechanically adjust to variable landing zones, and provide enhanced performance in high flow situations. The occluder is released by uncapping the delivery system from the distal to the proximal rim, allowing the nitinol mesh to recover its ‘‘memory’’ shape at blood temperature.
Implantation was performed through the right femoral artery, with a 6 French sheath, under general anaesthesia, with fluoroscopic and transoesophageal echocardiographic (TEE) guidance. After advancement of a 6-F multipurpose guiding catheter in proximity to the PVL canal, a guidewire was passed through the canal and then the guiding catheter was advanced over the wire through the PVL. Partial opening and deployment was obtained (Fig. 2 A,B). However, it was immediately observed that the plug, because of its size, would interfere with normal prosthetic leaflet motion, so it was recaptured and removed before final release. A decision was then made to try and deploy a 4 mm-Amplatzer Septal
Figure 2 A) Fluoroscopic image showing partial opening and deployment of vascular plug 2 through the paravalvular leak. B) Vascular Plug 2 completely opened. C) Fluoroscopic image of the 4 mm-Amplatzer Septal Occluder just delivered through the paravalvular leak. D) Transoesophageal echocardiography image showing persistent moderately severe aortic regurgitation after delivery of an Amplatzer Septal Occluder.
Please cite this article in press as: Rossi ML, et al. Paravalvular Leak Leading to Severe Aortic Valve Regurgitation after TAVI: Percutaneous Closure Strategy. Heart, Lung and Circulation (2015), http://dx.doi.org/10.1016/j.hlc.2015.04.163
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Occluder. The occluder was advanced within the same delivery sheath, and the distal disc was opened across the paravalvular leak. The sheath was subsequently pulled back and the second disc opened. After achieving a stable device position, confirmed by fluoroscopy, TEE and the so-called ‘‘push-and-pull’’ manoeuver, the device was released (Fig. 2 C). After delivery, however, there seemed to be residual severe aortic regurgitation through the leak by TEE. We had set a general goal for the procedure to decrease the degree of AR to at least grade moderate (Fig. 2 D). A second plug may have been deployed, but this did not seem a viable option because of the limited residual space between the prosthetic valve and surrounding tissues. At this point the procedure was terminated, the patient did reasonably well during hospitalisation and could be discharged on day 6. Only three months later however she was admitted again with acute pulmonary oedema. Echocardiography confirmed the persistence of severe aortic regurgitation. After further discussion within the Heart Team, it was decided to proceed with a percutaneous valve-in-valve implantation. TAVI was performed again via the right trans-femoral approach, and a 26 mm Medtronic Core Valve prosthesis was implanted (Fig. 3 A, B). Because of the size of the new prosthesis, an attempt was made to implant above the Edward Sapien XT 23, to avoid malfunction due to incomplete opening of the leaflets. Since TEE once more showed persistence of severe aortic insufficiency, a third valve, again a 26 mm Core Valve was implanted still a little higher
(Fig. 3 C). TEE showed only mild residual aortic regurgitation (Fig. 3 D), non-significant gradient. No significant pressure gradient across the valves was confirmed invasively. The patient was discharged on day 12. She has remained clinically stable, in NYHA class I-II, since then, with a repeat TTE at one year showing persistent normal aortic valvular function. In summary, treatment of PVL regurgitation in patients after TAVI remains one of the most challenging and difficult procedures in interventional cardiology. We learned several lessons from this most unusual case. Firstly, we showed how the initial approach was feasible as far as reaching through the opening and wiring the PVL. However, we speculate that in order to be successful new ‘‘custom-made’’ occlusion plugs should be developed and available, with sizing of the uppermost importance in order to avoid the observed interference with the movement of the valve leaflets. At present, dedicated devices are being clinically tested [1,5]. Three-dimensional TEE or CT, with 3D prints, may potentially aid in the future in the development of virtual ‘‘casts’’ of PVLs to guide selection of the proper customised sealing devices. Secondly, for similar reasons of lack of precise fitting through the defect, failure of the Amplatzer plug resulted in a degree of residual aortic insufficiency that, with hindsight, should have already been corrected during the first hospitalisation. We also learned that, in order to accurately seal a PVL with another valve, extremely precise positioning, at a height relative to the valvular plane that allows sealing with the covered circumferential portion of the new valve itself, while
Figure 3 A), B) Delivery of the first 26 mm Core-valve. C) Delivery of the second 26 mm Core-Valve. D) Transoesophageal echocardiography image showing mild residual aortic regurgitation after the valve-in-valve implantation.
Please cite this article in press as: Rossi ML, et al. Paravalvular Leak Leading to Severe Aortic Valve Regurgitation after TAVI: Percutaneous Closure Strategy. Heart, Lung and Circulation (2015), http://dx.doi.org/10.1016/j.hlc.2015.04.163
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allowing normal functioning and unrestricted opening of the new valve, is imperative to achieve a successful result. Finally, we acknowledge the significant excess costs that may be associated with such unforeseeable interventions for a unique but complex situation, that in our case can be estimated at around 40 to 50,000 euros.
References [1] Hammermeister K, Sethi GK, Henderson WG, Grover FL, Oprian C, Rahimtoola SH. Outcomes 15 years after valve replacement with a mechanical versus a bioprosthetic valve: final report of the Veterans Affairs randomized trial. J Am Coll Cardiol 2000;36:1152–8.
[2] Da´vila-Roma´n VG, Waggoner AD, Kennard ED, Holubkov R, Jamieson WR, Englberger L, et al. Artificial Valve Endocarditis Reduction Trial echocardiography study. Prevalence and severity of paravalvular regurgitation in the Artificial Valve Endocarditis Reduction Trial (AVERT) echocardiography study. J Am Coll Cardiol 2004;44:1467–72. [3] Moat NE, Ludman P, de Belder MA, Bridgewater B, Cunningham AD, Young CP, et al. Long-term outcomes after transcatheter aortic valve implantation in high-risk patients with severe aortic stenosis: the U.K. TAVI (United Kingdom Transcatheter Aortic Valve Implantation) Registry. J Am Coll Cardiol 2011;58:2130–8. [4] Ge´ne´reux P, Head SJ, Hahn R, Daneault B, Kodali S, Williams MR, et al. Paravalvular leak after transcatheter aortic valve replacement: the new Achilles’ heel? A comprehensive review of the literature. J Am Coll Cardiol 2013;61:1125–36. [5] Go¨ssl M, Rihal CS. Percutaneous treatment of aortic and mitral valve paravalvular regurgitation. Curr Cardiol Rep 2013;15:388.
Please cite this article in press as: Rossi ML, et al. Paravalvular Leak Leading to Severe Aortic Valve Regurgitation after TAVI: Percutaneous Closure Strategy. Heart, Lung and Circulation (2015), http://dx.doi.org/10.1016/j.hlc.2015.04.163
