International Journal of Cardiology 189 (2015) 235–237
Contents lists available at ScienceDirect
International Journal of Cardiology journal homepage: www.elsevier.com/locate/ijcard
Letter to the Editor
Immediate, same-setting paravalvular leak closure following transcatheter aortic valve replacement Jonathon M. White ⁎, Omar K. Khalique, Susheel K. Kodali Heart Valve Center, Columbia University Medical Center, New York, NY, USA
a r t i c l e
i n f o
Article history: Received 20 February 2015 Accepted 17 March 2015 Available online 20 March 2015 Keywords: Aortic stenosis Transcatheter aortic valve replacement Paravalvular regurgitation
Although transcatheter aortic valve replacement (TAVR) has emerged as an alternative to surgical aortic valve replacement (SAVR) for high-risk patients, paravalvular regurgitation (PVR) remains a concern that may limit the use of TAVR more broadly. Several studies have demonstrated that the presence of even as little as mild PVR is associated with worse late outcomes [1,2]. However, important differences in baseline characteristics exist in most of these studies so it remains unclear whether this relationship is causal or merely an association. Several procedural and anatomical factors have been associated with PVR, including the volume and distribution of annular calcification [3]. It is well established that pre-procedural imaging of the aortic annulus with multi-detector computed tomography (MDCT) improves valve sizing and reduces PVR but whether interventional measures to reduce PVR following TAVR alter prognosis is not known. Balloon postdilatation (PD) remains the mainstay of treatment of PVR after TAVR. Although PD has been shown to reduce PVR [4], there are potential associated risks, including stroke and annular rupture [5]. Many of the anatomical features that increase the risk of malapposition and PVR, including LVOT calcification, are also associated with aortic root rupture. Consequently, the decision to post-dilate or not in the face of PVR remains a challenging one for clinicians, who are left to make this judgment on a case-by-case basis. Abbreviations:TAVR, transcatheter aortic valve replacement; SAVR, surgical aortic valve replacement; PVR, paravalvular regurgitation; MDCT, multi-detector computed tomography; PD, post-dilatation; LVOT, left ventricular outflow tract; TEE, transesophageal echocardiogram; AVP, Amplatzer Vascular Plug ⁎ Corresponding author at: Heart Valve Center, Columbia University Medical Center, 177 Fort Washington Avenue, New York, NY 10032, USA. E-mail address: [email protected] (J.M. White).
http://dx.doi.org/10.1016/j.ijcard.2015.03.292 0167-5273/© 2015 Published by Elsevier Ireland Ltd.
Transcatheter paravalvular leak closure is a well-established therapeutic option for PVR following SAVR [6,7] and may represent an alternative to a strategy of aggressive PD in certain anatomical scenarios following TAVR. This technique has increasingly been employed in cases of significant PVR following TAVR, and numerous reports of intervention for symptomatic PVR long after the index TAVR procedure or in the setting of acute hemodynamic instability after TAVR exist [8,9]. The role of, and decision making involved in immediate, same-setting paravalvular leak closure in hemodynamically stable patients as a primary strategy to reduce PVR is not well described. We present the case of a patient with high-risk annular characteristics and significant PVR refractory to PD following TAVR and discuss the role that same-setting transcatheter paravalvular leak closure might have as a primary strategy to reduce PVR. An 86 year-old man with severe chronic obstructive pulmonary disease presented with class III heart failure and severe aortic stenosis. Given high surgical risk, he underwent TAVR. MDCT documented an aortic annular area of 494 mm2 and focal, heavy calcification within the annulus at the base of the left and non-coronary cusps, extending down onto the aorto-mitral curtain (Fig. 1). Transfemoral TAVR was performed with a 26 mm Sapien balloon-expandable valve (Edwards Lifesciences, Irvine, CA). Heavy calcification at the base of the left coronary cusp was clearly visible on angiography (Fig. 2). After deployment, transesophageal echocardiogram (TEE) showed moderate–severe paravalvular regurgitation (PVR) adjacent to the focal, heavy calcification in the left ventricular outflow tract (LVOT) (Fig. 3, Moving Images 1 and 2). After post-dilatation with a 22 mm Z-Med valvuloplasty balloon (NuMed, Hopkinton, NY), the valve appeared well-expanded but there was malapposition adjacent to the focal calcification in the LVOT and PVR remained unchanged. Given concern over the heavy, focal nature of the LVOT calcification, perceived risk of aortic rupture from more aggressive post-dilatation and understanding that the mechanism of the PVR related to poor valve apposition adjacent to calcification rather than under-expansion, percutaneous paravalvular leak closure was attempted. Under fluoroscopic and TEE guidance, taking great care to ensure that the wire did not pass through the valve struts, an 0.035″ angled Glidewire (Terumo, Tokyo, Japan) was passed exterior to the struts of the transcatheter valve and into the left ventricle. A 4Fr angled Glidecath (Terumo, Tokyo, Japan) was then advanced over the wire, into the ventricle. The wire was then removed and an 8 mm Amplatzer Vascular Plug (AVP) 4 (St Jude Medical, St Paul, MN) was then advanced through the 4Fr Glidecath. The distal portion of the device was extruded at the annular level near the base of the Sapien
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J.M. White et al. / International Journal of Cardiology 189 (2015) 235–237
Fig. 1. Gated cardiac computed tomography (CT) scan showing severe, focal calcification of the aortic annulus and left ventricular outflow tract beneath the left coronary cusp.
Fig. 2. Cineangiography during valve deployment showing heavy calcification (arrow) at the base of the left coronary cusp.
prosthesis. After unsheathing the aortic disc and confirming satisfactory position by TEE, the closure device was released (Fig. 4). Final TEE showed reduction in PVR from moderate–severe to mild (Fig. 5, Moving Image 3) and no central aortic regurgitation. The patient underwent an uneventful recovery, and was discharged on the third post-operative day on aspirin and clopidogrel. In this case, annular assessment was performed with MDCT, with the appropriate choice of a 26 mm valve (7% oversized for a 26 mm valve, 34% oversized for a 29 mm valve). Although moderate PVR remained after deployment of a 26 mm valve, the degree of oversizing in the case of a 29 mm valve would have presented undue risk given the heavy, focal root calcification and likely would not have resulted in better apposition to the LVOT. In our case, despite reasonable sizing, moderate–severe PVR remained despite post-dilatation and TEE evidence of excellent valve expansion. The problem lay in focal malapposition adjacent to the very severe, focal calcification at the base of the left cusp, extending into the LVOT. Although PD of underexpanded or asymmetrically expanded valves would seem likely to reduce PVR, no amount of PD is likely to obliterate PVR due to the mechanism observed in this case. This is important for clinicians to recognize as more aggressive PD is likely to not only be futile, but also pose increased risk of stroke or root rupture. Rather than further post-dilate or leave moderate PVR untreated and accept the adverse prognosis this may portend, immediate closure of the leak proved a successful option in this case.
J.M. White et al. / International Journal of Cardiology 189 (2015) 235–237
237
Fig. 3. 2D and 3D transesophageal echocardiogram (TEE) showing moderate–severe paravalvular regurgitation (PVR) adjacent to focal calcification (arrow) within the LVOT. Although well expanded, the valve is malapposed to the annulus posteriorly due to the focal calcification.
given the apparent prognostic importance of PVR, this strategy warrants further study. Supplementary data to this article can be found online at http://dx. doi.org/10.1016/j.ijcard.2015.03.292. Conflicts of interest The authors report no relationships that could be construed as a conflict of interest. References
Fig. 4. Fluoroscopy showing 8 mm Amplatzer Vascular Plug 4 (arrow) detached from delivery catheter, behind valve stent struts.
It is important for clinicians to consider the mechanism by which post-TAVR PVR occurs on a case-by-case basis. In cases of significant PVR immediately after TAVR where the mechanism of PVR suggests that post-dilatation is unlikely to be helpful and poses risk of aortic rupture, immediate percutaneous closure of significant paravalvular leaks should be considered. It is not known whether this strategy results in sustained improvements in PVR or improved clinical outcomes, but
[1] G. Athappan, E. Patvardhan, E.M. Tuzcu, et al., Incidence, predictors, and outcomes of aortic regurgitation after transcatheter aortic valve replacement: meta-analysis and systematic review of literature, J. Am. Coll. Cardiol. 61 (2013) 1585–1595. [2] S. Kodali, P. Pibarot, P.S. Douglas, et al., Paravalvular regurgitation after transcatheter aortic valve replacement with the Edwards Sapien valve in the PARTNER trial: characterizing patients and impact on outcomes, Eur. Heart J. 36 (7) (2015) 449–456. [3] O.K. Khalique, R.T. Hahn, H. Gada, et al., Quantity and location of aortic valve complex calcification predicts severity and location of paravalvular regurgitation and frequency of post-dilation after balloon-expandable transcatheter aortic valve replacement, J. Am. Coll. Cardiol. Intv. 7 (2014) 885–894. [4] R.T. Hahn, P. Pibarot, J. Webb, et al., Outcomes with post-dilation following transcatheter aortic valve replacement: the PARTNER I trial (placement of aortic transcatheter valve), J. Am. Coll. Cardiol. Intv. 7 (2014) 781–789. [5] R.K. Binder, J.G. Webb, A.B. Willson, et al., The impact of integration of a multidetector computed tomography annulus area sizing algorithm on outcomes of transcatheter aortic valve replacement: a prospective, multicenter, controlled trial, J. Am. Coll. Cardiol. 62 (2013) 431–438. [6] C.E. Ruiz, V. Jelnin, I. Kronzon, et al., Clinical outcomes in patients undergoing percutaneous closure of periprosthetic paravalvular leaks, J. Am. Coll. Cardiol. 58 (2011) 2210–2217. [7] P. Sorajja, A.K. Cabalka, D.J. Hagler, C.S. Rihal, Long-term follow-up of percutaneous repair of paravalvular prosthetic regurgitation, J. Am. Coll. Cardiol. 58 (2011) 2218–2224. [8] C.A. Martinez, V. Singh, B.P. O'Neill, et al., Management of paravalvular regurgitation after Edwards SAPIEN transcatheter aortic valve replacement: management of paravalvular regurgitation after TAVR, Catheter. Cardiovasc. Interv. 82 (2013) 300–311. [9] R. Saireddy, V. Subban, A. Lamana, et al., Immediate closure of paravalvular leak after transcatheter aortic valve implantation, Heart Lung Circ. 23 (2014) e251–e253.
Fig. 5. 2-Dimensional TEE (left two panels) and 3-dimensional TEE (right panel) following deployment of Amplatzer Vascular Plug (AVP) 4, showing now mild PVR.
Contents lists available at ScienceDirect
International Journal of Cardiology journal homepage: www.elsevier.com/locate/ijcard
Letter to the Editor
Immediate, same-setting paravalvular leak closure following transcatheter aortic valve replacement Jonathon M. White ⁎, Omar K. Khalique, Susheel K. Kodali Heart Valve Center, Columbia University Medical Center, New York, NY, USA
a r t i c l e
i n f o
Article history: Received 20 February 2015 Accepted 17 March 2015 Available online 20 March 2015 Keywords: Aortic stenosis Transcatheter aortic valve replacement Paravalvular regurgitation
Although transcatheter aortic valve replacement (TAVR) has emerged as an alternative to surgical aortic valve replacement (SAVR) for high-risk patients, paravalvular regurgitation (PVR) remains a concern that may limit the use of TAVR more broadly. Several studies have demonstrated that the presence of even as little as mild PVR is associated with worse late outcomes [1,2]. However, important differences in baseline characteristics exist in most of these studies so it remains unclear whether this relationship is causal or merely an association. Several procedural and anatomical factors have been associated with PVR, including the volume and distribution of annular calcification [3]. It is well established that pre-procedural imaging of the aortic annulus with multi-detector computed tomography (MDCT) improves valve sizing and reduces PVR but whether interventional measures to reduce PVR following TAVR alter prognosis is not known. Balloon postdilatation (PD) remains the mainstay of treatment of PVR after TAVR. Although PD has been shown to reduce PVR [4], there are potential associated risks, including stroke and annular rupture [5]. Many of the anatomical features that increase the risk of malapposition and PVR, including LVOT calcification, are also associated with aortic root rupture. Consequently, the decision to post-dilate or not in the face of PVR remains a challenging one for clinicians, who are left to make this judgment on a case-by-case basis. Abbreviations:TAVR, transcatheter aortic valve replacement; SAVR, surgical aortic valve replacement; PVR, paravalvular regurgitation; MDCT, multi-detector computed tomography; PD, post-dilatation; LVOT, left ventricular outflow tract; TEE, transesophageal echocardiogram; AVP, Amplatzer Vascular Plug ⁎ Corresponding author at: Heart Valve Center, Columbia University Medical Center, 177 Fort Washington Avenue, New York, NY 10032, USA. E-mail address: [email protected] (J.M. White).
http://dx.doi.org/10.1016/j.ijcard.2015.03.292 0167-5273/© 2015 Published by Elsevier Ireland Ltd.
Transcatheter paravalvular leak closure is a well-established therapeutic option for PVR following SAVR [6,7] and may represent an alternative to a strategy of aggressive PD in certain anatomical scenarios following TAVR. This technique has increasingly been employed in cases of significant PVR following TAVR, and numerous reports of intervention for symptomatic PVR long after the index TAVR procedure or in the setting of acute hemodynamic instability after TAVR exist [8,9]. The role of, and decision making involved in immediate, same-setting paravalvular leak closure in hemodynamically stable patients as a primary strategy to reduce PVR is not well described. We present the case of a patient with high-risk annular characteristics and significant PVR refractory to PD following TAVR and discuss the role that same-setting transcatheter paravalvular leak closure might have as a primary strategy to reduce PVR. An 86 year-old man with severe chronic obstructive pulmonary disease presented with class III heart failure and severe aortic stenosis. Given high surgical risk, he underwent TAVR. MDCT documented an aortic annular area of 494 mm2 and focal, heavy calcification within the annulus at the base of the left and non-coronary cusps, extending down onto the aorto-mitral curtain (Fig. 1). Transfemoral TAVR was performed with a 26 mm Sapien balloon-expandable valve (Edwards Lifesciences, Irvine, CA). Heavy calcification at the base of the left coronary cusp was clearly visible on angiography (Fig. 2). After deployment, transesophageal echocardiogram (TEE) showed moderate–severe paravalvular regurgitation (PVR) adjacent to the focal, heavy calcification in the left ventricular outflow tract (LVOT) (Fig. 3, Moving Images 1 and 2). After post-dilatation with a 22 mm Z-Med valvuloplasty balloon (NuMed, Hopkinton, NY), the valve appeared well-expanded but there was malapposition adjacent to the focal calcification in the LVOT and PVR remained unchanged. Given concern over the heavy, focal nature of the LVOT calcification, perceived risk of aortic rupture from more aggressive post-dilatation and understanding that the mechanism of the PVR related to poor valve apposition adjacent to calcification rather than under-expansion, percutaneous paravalvular leak closure was attempted. Under fluoroscopic and TEE guidance, taking great care to ensure that the wire did not pass through the valve struts, an 0.035″ angled Glidewire (Terumo, Tokyo, Japan) was passed exterior to the struts of the transcatheter valve and into the left ventricle. A 4Fr angled Glidecath (Terumo, Tokyo, Japan) was then advanced over the wire, into the ventricle. The wire was then removed and an 8 mm Amplatzer Vascular Plug (AVP) 4 (St Jude Medical, St Paul, MN) was then advanced through the 4Fr Glidecath. The distal portion of the device was extruded at the annular level near the base of the Sapien
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J.M. White et al. / International Journal of Cardiology 189 (2015) 235–237
Fig. 1. Gated cardiac computed tomography (CT) scan showing severe, focal calcification of the aortic annulus and left ventricular outflow tract beneath the left coronary cusp.
Fig. 2. Cineangiography during valve deployment showing heavy calcification (arrow) at the base of the left coronary cusp.
prosthesis. After unsheathing the aortic disc and confirming satisfactory position by TEE, the closure device was released (Fig. 4). Final TEE showed reduction in PVR from moderate–severe to mild (Fig. 5, Moving Image 3) and no central aortic regurgitation. The patient underwent an uneventful recovery, and was discharged on the third post-operative day on aspirin and clopidogrel. In this case, annular assessment was performed with MDCT, with the appropriate choice of a 26 mm valve (7% oversized for a 26 mm valve, 34% oversized for a 29 mm valve). Although moderate PVR remained after deployment of a 26 mm valve, the degree of oversizing in the case of a 29 mm valve would have presented undue risk given the heavy, focal root calcification and likely would not have resulted in better apposition to the LVOT. In our case, despite reasonable sizing, moderate–severe PVR remained despite post-dilatation and TEE evidence of excellent valve expansion. The problem lay in focal malapposition adjacent to the very severe, focal calcification at the base of the left cusp, extending into the LVOT. Although PD of underexpanded or asymmetrically expanded valves would seem likely to reduce PVR, no amount of PD is likely to obliterate PVR due to the mechanism observed in this case. This is important for clinicians to recognize as more aggressive PD is likely to not only be futile, but also pose increased risk of stroke or root rupture. Rather than further post-dilate or leave moderate PVR untreated and accept the adverse prognosis this may portend, immediate closure of the leak proved a successful option in this case.
J.M. White et al. / International Journal of Cardiology 189 (2015) 235–237
237
Fig. 3. 2D and 3D transesophageal echocardiogram (TEE) showing moderate–severe paravalvular regurgitation (PVR) adjacent to focal calcification (arrow) within the LVOT. Although well expanded, the valve is malapposed to the annulus posteriorly due to the focal calcification.
given the apparent prognostic importance of PVR, this strategy warrants further study. Supplementary data to this article can be found online at http://dx. doi.org/10.1016/j.ijcard.2015.03.292. Conflicts of interest The authors report no relationships that could be construed as a conflict of interest. References
Fig. 4. Fluoroscopy showing 8 mm Amplatzer Vascular Plug 4 (arrow) detached from delivery catheter, behind valve stent struts.
It is important for clinicians to consider the mechanism by which post-TAVR PVR occurs on a case-by-case basis. In cases of significant PVR immediately after TAVR where the mechanism of PVR suggests that post-dilatation is unlikely to be helpful and poses risk of aortic rupture, immediate percutaneous closure of significant paravalvular leaks should be considered. It is not known whether this strategy results in sustained improvements in PVR or improved clinical outcomes, but
[1] G. Athappan, E. Patvardhan, E.M. Tuzcu, et al., Incidence, predictors, and outcomes of aortic regurgitation after transcatheter aortic valve replacement: meta-analysis and systematic review of literature, J. Am. Coll. Cardiol. 61 (2013) 1585–1595. [2] S. Kodali, P. Pibarot, P.S. Douglas, et al., Paravalvular regurgitation after transcatheter aortic valve replacement with the Edwards Sapien valve in the PARTNER trial: characterizing patients and impact on outcomes, Eur. Heart J. 36 (7) (2015) 449–456. [3] O.K. Khalique, R.T. Hahn, H. Gada, et al., Quantity and location of aortic valve complex calcification predicts severity and location of paravalvular regurgitation and frequency of post-dilation after balloon-expandable transcatheter aortic valve replacement, J. Am. Coll. Cardiol. Intv. 7 (2014) 885–894. [4] R.T. Hahn, P. Pibarot, J. Webb, et al., Outcomes with post-dilation following transcatheter aortic valve replacement: the PARTNER I trial (placement of aortic transcatheter valve), J. Am. Coll. Cardiol. Intv. 7 (2014) 781–789. [5] R.K. Binder, J.G. Webb, A.B. Willson, et al., The impact of integration of a multidetector computed tomography annulus area sizing algorithm on outcomes of transcatheter aortic valve replacement: a prospective, multicenter, controlled trial, J. Am. Coll. Cardiol. 62 (2013) 431–438. [6] C.E. Ruiz, V. Jelnin, I. Kronzon, et al., Clinical outcomes in patients undergoing percutaneous closure of periprosthetic paravalvular leaks, J. Am. Coll. Cardiol. 58 (2011) 2210–2217. [7] P. Sorajja, A.K. Cabalka, D.J. Hagler, C.S. Rihal, Long-term follow-up of percutaneous repair of paravalvular prosthetic regurgitation, J. Am. Coll. Cardiol. 58 (2011) 2218–2224. [8] C.A. Martinez, V. Singh, B.P. O'Neill, et al., Management of paravalvular regurgitation after Edwards SAPIEN transcatheter aortic valve replacement: management of paravalvular regurgitation after TAVR, Catheter. Cardiovasc. Interv. 82 (2013) 300–311. [9] R. Saireddy, V. Subban, A. Lamana, et al., Immediate closure of paravalvular leak after transcatheter aortic valve implantation, Heart Lung Circ. 23 (2014) e251–e253.
Fig. 5. 2-Dimensional TEE (left two panels) and 3-dimensional TEE (right panel) following deployment of Amplatzer Vascular Plug (AVP) 4, showing now mild PVR.
