Catheterization and Cardiovascular Interventions 84:155–159 (2014)
Case Reports Paravalvular Leak Closure for Persisting Aortic Regurgitation after Implantation of the CoreValve Transcatheter Valve Petra Poliacikova, MD and David Hildick-Smith,* MD Significant aortic regurgitation after TAVI results in lack of symptomatic and prognostic benefit from the procedure and generally requires intervention. While most of the regurgitations can be successfully targeted with standard techniques, occasional patients have restrictive calcification resistant to post-dilatation and significant regurgitation persists. We present a case of refractory aortic regurgitation successfully treated with percutaneous paravalvular leak closure. An 81-year-old man with symptomatic severe aortic stenosis underwent a transfemoral CoreValve TAVI in December 2009. He had significant aortic regurgitation refractory to medical and interventional therapy including balloon post-dilatation, valve repositioning and valve-in-valve reimplantation. Aortic regurgitation remained severe and therefore in early 2013, we proceeded with an attempted percutaneous closure of the residual paraprosthetic leak. Using 6-French femoral access and a Terumo wire, the defect was successfully crossed with a 4French Multipurpose catheter and an 8 mm Amplatzer Vascular Plug 4 device (St. Jude Medical) was deployed through this catheter, resulting in abolition of aortic regurgitation on aortography and TOE, with associated excellent clinical response. Refractory paravalvular aortic regurgitation post CoreValve implantation can be successfully treated using the Amplatzer Vascular Plug 4 device. VC 2013 Wiley Periodicals, Inc. Key words: TAVI; percutaneous; paravalvular
INTRODUCTION
Since its inception in 2002, transcatheter aortic valve implantation (TAVI) has undergone a rapid transformation, with substantial improvements in device technology, operator experience and resulting clinical outcomes. It now holds a firm place in the management of severe aortic valvular disease, with outcomes comparable to surgical replacement [1]. The presence of some degree of aortic regurgitation (AR) is not uncommon immediately post-procedure— mild AR has been described in 47–78% cases [1–3]. Mild AR has long been considered benign, but the most recently published reports suggest that even mild AR may be associated with increased mortality [4,5]. The adverse impact of moderate to severe aortic regurgitation has been well described and confirmed in randomized trials as well as large registries [1–3,5]. With a hazard ratio for all-cause mortality of 1.66– 3.79, several multivariate analyses suggests that significant AR may even counteract the survival benefit of TAVI over standard medical treatment [6]. No less C 2013 Wiley Periodicals, Inc. V
importantly, patients left with significant aortic regurgitations often fail to derive good symptomatic benefit from the procedure. Additional Supporting Information may be found in the online version of this article. Sussex Cardiac Centre, Brighton and Sussex University Hospitals NHS Trust, Brighton, United Kingdom Conflict of interest: Nothing to report. Disclosures: Dr. Hildick-Smith is a proctor for Medtronic CoreValve. *Correspondence to: Sussex Cardiac Centre, Brighton and Sussex University Hospitals NHS Trust, Brighton, United Kingdom. E-mail: [email protected] Received 3 April 2013; Revision accepted 10 October 2013 DOI: 10.1002/ccd.25254 Published online 15 October 2013 in Wiley Online Library (wileyonlinelibrary.com)
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Fig. 1. Mild aortic regurgitation after snaring and postdilatation as shown by aortogram.
Paravalvular aortic regurgitation can result from anatomical misplacement of the valve (too high or too low), under sizing of the prosthesis, or asymmetric valve expansion due to heavy calcification. Establishing the cause, and quantifying the degree, of aortic regurgitation, are crucial for appropriate management [7]. Trivial to mild regurgitation is usually clinically silent and does not require any intervention. Often, the degree of regurgitation is found to be reduced at follow-up [8]. Moderate to severe leaks require intervention, aiming to reduce regurgitation to less than grade 2. Para-valvular leaks due to under-expanded and malapposed valves are usually treated successfully with balloon post-dilatation [9]. However, occasional patients have restrictive calcification which is resistant to post-dilatation and significant regurgitation persists. Percutaneous paravalvular leak closure, which is successfully used to treat paravalvular leaks of surgical prostheses, might therefore be an alternative, and indeed, successful closures of Edwards valve paravalvular regurgitation have recently been reported [10]. We present the management of a patient with significant refractory aortic regurgitation post CoreValve implantation.
CASE PRESENTATION
An 81-year-old man with symptomatic severe aortic stenosis was referred to our institution for consideration of TAVI in 2009. His previous medical history included coronary artery bypass grafting in 1986, diabetes
mellitus, paroxysmal atrial flutter treated with radiofrequency ablation in 2008 and pacemaker implantation in 2009. At the multidisciplinary team meeting (MDT), repeat operation was considered by the surgeons to be inadvisable as the left internal mammary graft was adherent to the sternum. A transthoracic echocardiogram (TTE) confirmed severe aortic stenosis, with a peak gradient (PG) of 64 mm Hg, aortic valve area (AVA) 0.8 cm2, mild AR, and good left ventricular (LV) systolic function. The anteroposterior aortic annulus was measured at 27 mm. In view of this relatively large annulus, TOE was requested and suggested an annular measurement of 26 mm. Coronary angiography confirmed severe triple vessel coronary artery disease with patent grafts. The iliofemoral arteries were smooth and of good calibre for transfemoral TAVI, which he underwent in December 2009, under anesthetic sedation [11]. The native valve was pre-dilated using a 26 mm Z-Med-II balloon. A 29-mm CoreValve was implanted in a good initial position, but there was downward migration on release with resultant severe aortic regurgitation. The valve was snared and lifted into a more suitable position and was post-dilated there with a 28 mm Z-med balloon. An aortogram and echocardiogram at that stage showed mild to moderate aortic regurgitation, which was accepted (Figs. 1 and 2; Supporting Information Video S1). At 6-weeks follow up, the patient reported only mild clinical improvement. Transthoracic echocardiography revealed a severe paraprosthetic leak with a pressure half-time of 209 ms. The valve appeared underexpanded, with a mediolateral diameter of 29 mm and an antero-posterior diameter of 21 mm only despite balloon post-dilatation. The patient was rediscussed at the structural heart multidisciplinary team meeting and after much discussion a repeat TAVI procedure was scheduled, on the grounds that the valve remained low and there might be incomplete sealing between the upper part of the skirt of the valve and the annulus. The repeat procedure was performed in December 2010 using the same approach and a new 29 mm CoreValve was deployed 8 mm above the base of the first one. An aortogram disappointingly revealed residual moderate aortic regurgitation, and this was reduced only slightly by postdilatation with a further 28 mm Z-med balloon. An area of calcification was visible on transthoracic echocardiography where there was possible incomplete expansion of the two CoreValve prostheses. After initial clinical improvement when seen 6 weeks later in clinic, the patient began to deteriorate, with breathlessness on only mild exertion. He had clinical signs consistent with severe aortic regurgitation but
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
Percutaneous Closure of CoreValve Paravalvular Leak
157
Fig. 2. Moderate aortic regurgitation after snaring and post-dilatation as shown by echocardiogram. [Color figure can be viewed in the online issue, which is available at wileyonlinelibrary.com.]
Fig. 3. Left posterolateral leak visualized in left anterior oblique projection resulting in grade 3 aortic regurgitation.
echocardiographically it was reported as only moderate. A TOE was arranged and this demonstrated a moderate to severe left posterolateral paraprosthetic leak due to extrinsic calcific compression (Supporting Information Video S2). The cross-sectional area of the high velocity color flow Doppler was measured at 1.2 0.5 cm. The patient’s situation was again discussed at the TAVI MDT. Surgery was considered to be a last resort. Hope was expressed that a paravalvular leak closure
procedure might conceivably be successful and it was agreed that this should be tried before other options. The patient’s third procedure was therefore scheduled and performed in January 2013 under general anesthesia with TOE guidance, according to our usual practice for paravalvular leak closure [12]. Using a left anterior oblique projection, the left posterolateral leak could be clearly visualized (Fig. 3 and Supporting Information Video S3). An initial aortogram confirmed grade 3 aortic regurgitation (Fig. 3 and Supporting Information Video S3). Using 6-French arterial access, the left coronary margin of the two CoreValve prostheses was probed using an Amplatz Left 1 (Boston Scientific Corporation) catheter and a 260 cm 0.0350 Terumo wire. The wire was advanced through the stent struts of the valve, high up above the supra-annular valve itself and the paraprosthetic leak was then crossed without great difficulty (Fig. 4). The AL 1 catheter would not advance into the ventricle and therefore we exchanged for a 4French Multipurpose 1 diagnostic catheter (Boston Scientific Corporation). This gradually advanced over the guidewire through the struts into the left ventricle and an 8 mm Amplatzer Vascular Plug 4 device (St. Jude Medical) was passed down this 4-F multipurpose catheter and was deployed along the length of the paravalvular leak (Fig. 5 and Supporting Information Video S4). A good device position and CoreValve function was confirmed on TOE. Aortic regurgitation appeared to be diminished and therefore the device was released. To our collective surprise and pleasure, after release of the device, an aortogram showed trivial aortic regurgitation only (Fig. 6 and Supporting Information Video S5).
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
158
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Fig. 4. Terumo wire crossing through the struts of CoreValve.
Fig. 5. Deployment of an 8 mm AVP 4.
The patient was discharged later the same day, with a prescription for aspirin 75 mg daily, and has since been reviewed in the outpatient clinic. His breathing is greatly improved, and he is delighted with the result. A further transthoracic echocardiogram has shown trivial AR only. DISCUSSION
This case illustrates the complexity of post-TAVI aortic regurgitation quantification and management.
Fig. 6. Trivial aortic regurgitation after percutaneous paravalvular leak closure.
Echocardiographic assessment of transcatheter paravalvular regurgitation is notoriously difficult [13]. Standard echocardiographic parameters seem not necessarily to apply and there is frequently mismatch between clinical, echocardiographic, and angiographic indices [10]. In this particular case, the paraprosthetic leak was refractory to standard corrective measures, including valve snare lifting, balloon post-dilatation and valve-invalve implantation. Ultimately it was felt that focal severe calcification was causing circumferential apposition of the prosthetic valve, with resultant severe aortic regurgitation. Percutaneous closure with the AVP4 device proved to be an ideal method of dealing with the localized leak in this case. The self-expanding nitinol mesh occlusion device is attached to a 155-cm delivery wire and is unique in that it will pass down an 0.0380 catheter lumen. As such, it is the only device likely to be able to negotiate the lattice of the CoreValve prosthesis, which is the key point in this procedure, as there is no room to the side of the upper bulb of the CoreValve as opposed to the design of the Edwards SAPIEN. In this case, the largest device (8 mm) was taken and effectively closed the paravalvular leak. It is noteworthy that the device was smaller than the “effective orifice area” echocardiographically estimated by color flow Doppler. This is a frequent observation in paravalvular leak closure cases. The Amplatzer Vascular Plugs are principally designed for intravascular use, but have proved invaluable for closure of paraprosthetic valvular leaks [12,14–16]. There are recent reports of Amplatzer Vascular plug treatment of
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
Percutaneous Closure of CoreValve Paravalvular Leak
Edwards SAPIEN paravalvular regurgitation [10,17–19]. To the best of our knowledge, this is the first report of its use for CoreValve paravalvular leak closure.
CONCLUSION
Refractory paravalvular aortic regurgitation post CoreValve implantation can be successfully treated in specific circumstances using the Amplatzer Vascular Plug 4 device. REFERENCES 1. Smith C, Leon M, Mack M, Miller D, Moses J, Svensson L, Tuzcu E, Webb J, Fontana G, Makkar R, Wiliams M, Dewey T, Kapadia S, Babaliaros V, Thourani V, Corso P, Pichard A, Bavaria J, Herrmann H, Akin J, Anderson W, Wang D, Pocock S. Transcatheter versus surgical aortic valve replacement in high-risk patients. N Engl J Med 2011;364:2187–2198. 2. Leon M, Smith C, Mack M, Miller D, Moses J, Svensson L, Tuzcu E, Webb J, Fontana G, Makkar R, Brown D, Block P, Guyton R, Pichard A, Bavaria J, Herrmann H, Douglas P, Petersen J, Akin J, Anderson W, Wang A, Pocock S for the PARTNER Trial Investigators. Transcatheter Aortic-Valve Implantation for Aortic Stenosis in Patients Who Cannot Undergo Surgery. N Engl J Med 2010;363:1597–1607. 3. Moat NE, Ludman P, de Belder MA, Bridgewater B, Cunningham AD, Young CP, Thomas M, Kovac J, Spyt T, MacCarthy PA, Wendler O, Hildick-Smith D, Davies SW, Trivedi U, Blackman DJ, Levy RD, Brecker SJD, Baumbach A, Daniel T, Gray H, Mullen MJ. Long term outcomes after aortic valve implantation in high-risk patients with severe aortic stenosis. The U.K.TAVI registry. J Am Coll Cardiol 2011;58: 2130–2138. 4. Kodali SK, Williams MR, Smith CR, Svensson LG, Webb JG, Makkar RR, Fontana GP, Dewey TM, Thourani VH, Pichard AD, Fischbein M, Szeto WY, Lim S, Greason KL, Teirstein PS, Malaisrie SC, Douglas PS, Hahn RT, Whisenant B, Zajarias A, Wang D, Akin JJ, Anderson WN, Leon MB; PARTNER Trial Investigators. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med. 2012;366:1686–1695. 5. Athappan G, Patvardhan E, Tuzcu EM, Svensson LG, Lemos PA, Fraccaro C, Tarantini G, Sinning JM, Nickenig G, Capodanno D, Tamburino C, Latib A, Colombo A, Kapadia SR. Incidence, predictors, and outcomes of aortic regurgitation after transcatheter aortic valve replacement: Meta-analysis and systematic review of literature. J Am Coll Cardiol 2013;61: 1585–1595. 6. Jilaihawi H, Makkar R. Prognostic impact of aortic regurgitation after transcatheter aortic valve implantation. EuroIntervention 2012;8:Q31–Q33.
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7. Sinning JM, Vasa-Nicotera M, Chin D, Hammerstingl C, Ghanem A, Bence J, Kovac J, Grube E, Nickenig G, Werner N. Evaluation and management of paravalvular aortic regurgitation after transcatheter aortic valve replacement. J Am Coll Cardiol 2013;62:11–20. 8. Rajani R, Kakad M, Khawaja M, Lee L, James R, Saha M, Hildick-Smith D. Paravalvular regurgitation one year after transcatheter aortic valve implantation. Catheter Cardiovasc Interv 2010;75:868–872. 9. Nombela-Franco L, Rodes-Cabau J, DeLarochellie`re R, Larose E, Doyle D, Villeneuve J, Bergeron S, Bernier M, Amat-Santos IJ, Mok M, Urena M, Rheault M, Dumesnil J, C^ote M, Pibarot P, Dumont E. Predictive factors, efficacy, and safety of balloon post-dilation after transcatheter aortic valve implantation with a balloon-expandable valve. JACC Cardiovasc Interv. 2012;5: 499–512. 10. Estevez-Loureiro R, Salgado-Fernandez J, Vazquez-Gonzalez N. Percutaneous closure of paravalvular leaks after transcatheter aortic valve implantation with Edwards SAPIEN prosthesis: A report of two cases. J Invasive Cardiol. 2013;25:92–95. 11. Behan M, Haworth P, Hutchinson N, Trivedi U, Laborde JC, Hildick-Smith D. Percutaneous aortic valve implants under sedation: Our initial experience. Catheter Cardiovasc Interv 2008;72: 1012–1015. 12. Hildick-Smith D, Behan MW, De Giovanni J. Percutaneous closure of an aortic paravalvular leak via the transradial approach. Catheter Cardiovasc Interv 2007;69:708–710. 13. Zamorano JL, Badano LP, Bruce C, et al. EAE/ASE recommendations for the use of echocardiography in new transcatheter interventions for valvular heart disease. Eur J Echocardiogr 2011;12:557–584. 14. Nietlispach F, Johnson M, Moss RR, Wijesinghe N, Gurvitch R, Tay EL, Thompson C, Webb JG. Transcatheter closure of paravalvular defects using a purpose-specific occluder. JACC Cardiovasc Interv 2010;3:759–765. 15. Smolka G, Pysz P, Jasinski M. Two-stage percutaneous closure of paravalvular leak in a patient with stentless aortic bioprosthesis. Catheter Cardiovasc Interv 2013;82:E119–E123. 16. Ruiz CE, Jelnin V, Kronzon I, Dudiy Y, Del Valle-Fernandez R, Einhorn BN, Chiam PT, Martinez C, Eiros R, Roubin G, Cohen HA.Clinical outcomes in patients undergoing percutaneous closure of periprosthetic paravalvular leaks. J Am Coll Cardiol. 2011;58:2210–2217. 17. Sinning JM, Vasa-Nicotera M, Werner N, Nickenig G, Hammerstingl C. Interventional closure of paravalvular leakage after transcatheter aortic valve implantation. Eur Heart J 2012; 33:2498. 18. Whisenant B, Jones K, Horton KD, Horton S. Device closure of paravalvular defects following transcatheter aortic valve replacement with the Edwards Sapien valve. Catheter Cardiovasc Interv 2013;81:901–905. 19. Luu J, Ali O, Feldman T, Price MJ. Percutaneous closure of paravalvular leak after transcatheter aortic valve replacement. J Am Coll Cardiol Interv 2013;6:e6–e8.
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
Case Reports Paravalvular Leak Closure for Persisting Aortic Regurgitation after Implantation of the CoreValve Transcatheter Valve Petra Poliacikova, MD and David Hildick-Smith,* MD Significant aortic regurgitation after TAVI results in lack of symptomatic and prognostic benefit from the procedure and generally requires intervention. While most of the regurgitations can be successfully targeted with standard techniques, occasional patients have restrictive calcification resistant to post-dilatation and significant regurgitation persists. We present a case of refractory aortic regurgitation successfully treated with percutaneous paravalvular leak closure. An 81-year-old man with symptomatic severe aortic stenosis underwent a transfemoral CoreValve TAVI in December 2009. He had significant aortic regurgitation refractory to medical and interventional therapy including balloon post-dilatation, valve repositioning and valve-in-valve reimplantation. Aortic regurgitation remained severe and therefore in early 2013, we proceeded with an attempted percutaneous closure of the residual paraprosthetic leak. Using 6-French femoral access and a Terumo wire, the defect was successfully crossed with a 4French Multipurpose catheter and an 8 mm Amplatzer Vascular Plug 4 device (St. Jude Medical) was deployed through this catheter, resulting in abolition of aortic regurgitation on aortography and TOE, with associated excellent clinical response. Refractory paravalvular aortic regurgitation post CoreValve implantation can be successfully treated using the Amplatzer Vascular Plug 4 device. VC 2013 Wiley Periodicals, Inc. Key words: TAVI; percutaneous; paravalvular
INTRODUCTION
Since its inception in 2002, transcatheter aortic valve implantation (TAVI) has undergone a rapid transformation, with substantial improvements in device technology, operator experience and resulting clinical outcomes. It now holds a firm place in the management of severe aortic valvular disease, with outcomes comparable to surgical replacement [1]. The presence of some degree of aortic regurgitation (AR) is not uncommon immediately post-procedure— mild AR has been described in 47–78% cases [1–3]. Mild AR has long been considered benign, but the most recently published reports suggest that even mild AR may be associated with increased mortality [4,5]. The adverse impact of moderate to severe aortic regurgitation has been well described and confirmed in randomized trials as well as large registries [1–3,5]. With a hazard ratio for all-cause mortality of 1.66– 3.79, several multivariate analyses suggests that significant AR may even counteract the survival benefit of TAVI over standard medical treatment [6]. No less C 2013 Wiley Periodicals, Inc. V
importantly, patients left with significant aortic regurgitations often fail to derive good symptomatic benefit from the procedure. Additional Supporting Information may be found in the online version of this article. Sussex Cardiac Centre, Brighton and Sussex University Hospitals NHS Trust, Brighton, United Kingdom Conflict of interest: Nothing to report. Disclosures: Dr. Hildick-Smith is a proctor for Medtronic CoreValve. *Correspondence to: Sussex Cardiac Centre, Brighton and Sussex University Hospitals NHS Trust, Brighton, United Kingdom. E-mail: [email protected] Received 3 April 2013; Revision accepted 10 October 2013 DOI: 10.1002/ccd.25254 Published online 15 October 2013 in Wiley Online Library (wileyonlinelibrary.com)
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Poliacikova and Hildick-Smith
Fig. 1. Mild aortic regurgitation after snaring and postdilatation as shown by aortogram.
Paravalvular aortic regurgitation can result from anatomical misplacement of the valve (too high or too low), under sizing of the prosthesis, or asymmetric valve expansion due to heavy calcification. Establishing the cause, and quantifying the degree, of aortic regurgitation, are crucial for appropriate management [7]. Trivial to mild regurgitation is usually clinically silent and does not require any intervention. Often, the degree of regurgitation is found to be reduced at follow-up [8]. Moderate to severe leaks require intervention, aiming to reduce regurgitation to less than grade 2. Para-valvular leaks due to under-expanded and malapposed valves are usually treated successfully with balloon post-dilatation [9]. However, occasional patients have restrictive calcification which is resistant to post-dilatation and significant regurgitation persists. Percutaneous paravalvular leak closure, which is successfully used to treat paravalvular leaks of surgical prostheses, might therefore be an alternative, and indeed, successful closures of Edwards valve paravalvular regurgitation have recently been reported [10]. We present the management of a patient with significant refractory aortic regurgitation post CoreValve implantation.
CASE PRESENTATION
An 81-year-old man with symptomatic severe aortic stenosis was referred to our institution for consideration of TAVI in 2009. His previous medical history included coronary artery bypass grafting in 1986, diabetes
mellitus, paroxysmal atrial flutter treated with radiofrequency ablation in 2008 and pacemaker implantation in 2009. At the multidisciplinary team meeting (MDT), repeat operation was considered by the surgeons to be inadvisable as the left internal mammary graft was adherent to the sternum. A transthoracic echocardiogram (TTE) confirmed severe aortic stenosis, with a peak gradient (PG) of 64 mm Hg, aortic valve area (AVA) 0.8 cm2, mild AR, and good left ventricular (LV) systolic function. The anteroposterior aortic annulus was measured at 27 mm. In view of this relatively large annulus, TOE was requested and suggested an annular measurement of 26 mm. Coronary angiography confirmed severe triple vessel coronary artery disease with patent grafts. The iliofemoral arteries were smooth and of good calibre for transfemoral TAVI, which he underwent in December 2009, under anesthetic sedation [11]. The native valve was pre-dilated using a 26 mm Z-Med-II balloon. A 29-mm CoreValve was implanted in a good initial position, but there was downward migration on release with resultant severe aortic regurgitation. The valve was snared and lifted into a more suitable position and was post-dilated there with a 28 mm Z-med balloon. An aortogram and echocardiogram at that stage showed mild to moderate aortic regurgitation, which was accepted (Figs. 1 and 2; Supporting Information Video S1). At 6-weeks follow up, the patient reported only mild clinical improvement. Transthoracic echocardiography revealed a severe paraprosthetic leak with a pressure half-time of 209 ms. The valve appeared underexpanded, with a mediolateral diameter of 29 mm and an antero-posterior diameter of 21 mm only despite balloon post-dilatation. The patient was rediscussed at the structural heart multidisciplinary team meeting and after much discussion a repeat TAVI procedure was scheduled, on the grounds that the valve remained low and there might be incomplete sealing between the upper part of the skirt of the valve and the annulus. The repeat procedure was performed in December 2010 using the same approach and a new 29 mm CoreValve was deployed 8 mm above the base of the first one. An aortogram disappointingly revealed residual moderate aortic regurgitation, and this was reduced only slightly by postdilatation with a further 28 mm Z-med balloon. An area of calcification was visible on transthoracic echocardiography where there was possible incomplete expansion of the two CoreValve prostheses. After initial clinical improvement when seen 6 weeks later in clinic, the patient began to deteriorate, with breathlessness on only mild exertion. He had clinical signs consistent with severe aortic regurgitation but
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
Percutaneous Closure of CoreValve Paravalvular Leak
157
Fig. 2. Moderate aortic regurgitation after snaring and post-dilatation as shown by echocardiogram. [Color figure can be viewed in the online issue, which is available at wileyonlinelibrary.com.]
Fig. 3. Left posterolateral leak visualized in left anterior oblique projection resulting in grade 3 aortic regurgitation.
echocardiographically it was reported as only moderate. A TOE was arranged and this demonstrated a moderate to severe left posterolateral paraprosthetic leak due to extrinsic calcific compression (Supporting Information Video S2). The cross-sectional area of the high velocity color flow Doppler was measured at 1.2 0.5 cm. The patient’s situation was again discussed at the TAVI MDT. Surgery was considered to be a last resort. Hope was expressed that a paravalvular leak closure
procedure might conceivably be successful and it was agreed that this should be tried before other options. The patient’s third procedure was therefore scheduled and performed in January 2013 under general anesthesia with TOE guidance, according to our usual practice for paravalvular leak closure [12]. Using a left anterior oblique projection, the left posterolateral leak could be clearly visualized (Fig. 3 and Supporting Information Video S3). An initial aortogram confirmed grade 3 aortic regurgitation (Fig. 3 and Supporting Information Video S3). Using 6-French arterial access, the left coronary margin of the two CoreValve prostheses was probed using an Amplatz Left 1 (Boston Scientific Corporation) catheter and a 260 cm 0.0350 Terumo wire. The wire was advanced through the stent struts of the valve, high up above the supra-annular valve itself and the paraprosthetic leak was then crossed without great difficulty (Fig. 4). The AL 1 catheter would not advance into the ventricle and therefore we exchanged for a 4French Multipurpose 1 diagnostic catheter (Boston Scientific Corporation). This gradually advanced over the guidewire through the struts into the left ventricle and an 8 mm Amplatzer Vascular Plug 4 device (St. Jude Medical) was passed down this 4-F multipurpose catheter and was deployed along the length of the paravalvular leak (Fig. 5 and Supporting Information Video S4). A good device position and CoreValve function was confirmed on TOE. Aortic regurgitation appeared to be diminished and therefore the device was released. To our collective surprise and pleasure, after release of the device, an aortogram showed trivial aortic regurgitation only (Fig. 6 and Supporting Information Video S5).
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
158
Poliacikova and Hildick-Smith
Fig. 4. Terumo wire crossing through the struts of CoreValve.
Fig. 5. Deployment of an 8 mm AVP 4.
The patient was discharged later the same day, with a prescription for aspirin 75 mg daily, and has since been reviewed in the outpatient clinic. His breathing is greatly improved, and he is delighted with the result. A further transthoracic echocardiogram has shown trivial AR only. DISCUSSION
This case illustrates the complexity of post-TAVI aortic regurgitation quantification and management.
Fig. 6. Trivial aortic regurgitation after percutaneous paravalvular leak closure.
Echocardiographic assessment of transcatheter paravalvular regurgitation is notoriously difficult [13]. Standard echocardiographic parameters seem not necessarily to apply and there is frequently mismatch between clinical, echocardiographic, and angiographic indices [10]. In this particular case, the paraprosthetic leak was refractory to standard corrective measures, including valve snare lifting, balloon post-dilatation and valve-invalve implantation. Ultimately it was felt that focal severe calcification was causing circumferential apposition of the prosthetic valve, with resultant severe aortic regurgitation. Percutaneous closure with the AVP4 device proved to be an ideal method of dealing with the localized leak in this case. The self-expanding nitinol mesh occlusion device is attached to a 155-cm delivery wire and is unique in that it will pass down an 0.0380 catheter lumen. As such, it is the only device likely to be able to negotiate the lattice of the CoreValve prosthesis, which is the key point in this procedure, as there is no room to the side of the upper bulb of the CoreValve as opposed to the design of the Edwards SAPIEN. In this case, the largest device (8 mm) was taken and effectively closed the paravalvular leak. It is noteworthy that the device was smaller than the “effective orifice area” echocardiographically estimated by color flow Doppler. This is a frequent observation in paravalvular leak closure cases. The Amplatzer Vascular Plugs are principally designed for intravascular use, but have proved invaluable for closure of paraprosthetic valvular leaks [12,14–16]. There are recent reports of Amplatzer Vascular plug treatment of
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
Percutaneous Closure of CoreValve Paravalvular Leak
Edwards SAPIEN paravalvular regurgitation [10,17–19]. To the best of our knowledge, this is the first report of its use for CoreValve paravalvular leak closure.
CONCLUSION
Refractory paravalvular aortic regurgitation post CoreValve implantation can be successfully treated in specific circumstances using the Amplatzer Vascular Plug 4 device. REFERENCES 1. Smith C, Leon M, Mack M, Miller D, Moses J, Svensson L, Tuzcu E, Webb J, Fontana G, Makkar R, Wiliams M, Dewey T, Kapadia S, Babaliaros V, Thourani V, Corso P, Pichard A, Bavaria J, Herrmann H, Akin J, Anderson W, Wang D, Pocock S. Transcatheter versus surgical aortic valve replacement in high-risk patients. N Engl J Med 2011;364:2187–2198. 2. Leon M, Smith C, Mack M, Miller D, Moses J, Svensson L, Tuzcu E, Webb J, Fontana G, Makkar R, Brown D, Block P, Guyton R, Pichard A, Bavaria J, Herrmann H, Douglas P, Petersen J, Akin J, Anderson W, Wang A, Pocock S for the PARTNER Trial Investigators. Transcatheter Aortic-Valve Implantation for Aortic Stenosis in Patients Who Cannot Undergo Surgery. N Engl J Med 2010;363:1597–1607. 3. Moat NE, Ludman P, de Belder MA, Bridgewater B, Cunningham AD, Young CP, Thomas M, Kovac J, Spyt T, MacCarthy PA, Wendler O, Hildick-Smith D, Davies SW, Trivedi U, Blackman DJ, Levy RD, Brecker SJD, Baumbach A, Daniel T, Gray H, Mullen MJ. Long term outcomes after aortic valve implantation in high-risk patients with severe aortic stenosis. The U.K.TAVI registry. J Am Coll Cardiol 2011;58: 2130–2138. 4. Kodali SK, Williams MR, Smith CR, Svensson LG, Webb JG, Makkar RR, Fontana GP, Dewey TM, Thourani VH, Pichard AD, Fischbein M, Szeto WY, Lim S, Greason KL, Teirstein PS, Malaisrie SC, Douglas PS, Hahn RT, Whisenant B, Zajarias A, Wang D, Akin JJ, Anderson WN, Leon MB; PARTNER Trial Investigators. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med. 2012;366:1686–1695. 5. Athappan G, Patvardhan E, Tuzcu EM, Svensson LG, Lemos PA, Fraccaro C, Tarantini G, Sinning JM, Nickenig G, Capodanno D, Tamburino C, Latib A, Colombo A, Kapadia SR. Incidence, predictors, and outcomes of aortic regurgitation after transcatheter aortic valve replacement: Meta-analysis and systematic review of literature. J Am Coll Cardiol 2013;61: 1585–1595. 6. Jilaihawi H, Makkar R. Prognostic impact of aortic regurgitation after transcatheter aortic valve implantation. EuroIntervention 2012;8:Q31–Q33.
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Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
