Catheterization and Cardiovascular Interventions 86:152–153 (2015)
Editorial Comment Predicting Paravalvular Leak after Balloon-Expandable TAVR Amar Krishnaswamy, MD, and E. Murat Tuzcu,* MD Department of Cardiovascular Medicine, Heart and Vascular Institute, Cleveland Clinic, Cleveland, OH
Key Points
Objective measurement of a Valve Calcification Index (calcium volume/BSA) may predict PVL after TAVR using a cutoff value > 418 mm3/mm2 Oversizing the balloon-expandable SAPIEN valve with a goal ratio of valve diameter: average annulus diameter > 1.055 may reduce PVL after TAVR Single parameters are unlikely to provide adequate sensitivity to reduce PVL; a thorough analysis of root sizing, calcification, and morphology is important to balloon-expandable TAVR safety and efficacy
Paravalvular leak (PVL) after transcatheter aortic valve replacement (TAVR) is an important source of morbidity and mortality [1]. As we provide TAVR to younger patients and those at intermediate surgical risk, it is even more important that we optimize this procedure’s safety and efficacy in comparision to the historic gold standard of surgical aortic valve replacement (SAVR). Therefore, proper valve sizing and selection is of paramount importance in the preprocedural planning for TAVR. Watanabe and colleagues in this issue aimed to identify CT-derived predictors of PVL after implantation of the balloon-expandable Edwards SAPIEN series of valves. Among 545 consecutive, high-risk patients undergoing TAVR between 2009 and 2012, 176 patients underwent SAPIEN valve implantation and had a CT available. Various parameters of the aortic root were evaluated with respect to annulus and valve sizing, as well as calcification of the aortic root complex. After multivariate analysis, the valve calcification index [VCI; calcification volume (mm3)/body surface area (mm2)] of the aortic root (OR 1.002) and valve diC 2015 Wiley Periodicals, Inc. V
ameter/calculated average annulus diameter (CAAD) (OR 0.683) emerged as the major predictors of PVL 2. Specifically, receiver-operating curve (ROC) analysis demonstrated cutoff values for PVL 2 of VCI > 418 mm3/mm2 and VD/CAAD < 1.055. The investigators further created a “PVL Score,” assigning 1-point to each of these parameters, and demonstrated an incidence of PVL 2 of 5.3%, 11.8%, and 37.5% for PVL scores of 0, 1, and 2, respectively. Calcification of the aortic root complex is an important predictor of PVL, and also predicts annular rupture in patients undergoing SAPIEN valve implantation [2,3]. The current investigation aimed to further the available body of evidence in this regard by providing a specific cutoff value of the VCI to best predict significant PVL. It is important to note, however, that calcium attenuation is not always consistent across scans, which may limit the widespread applicability of this single number. However, a systematic calcification analysis that provides the VCI in addition to important factors such calcium location and distribution may be beneficial as an adjunctive parameter to use in optimizing valve sizing and selection and reducing the risk of annular trauma. Similarly, prior investigations have demonstrated the importance of CT-guided valve-oversizing to reduce the incidence of important PVL, as well as its contribution to annular rupture [4]. In this regard, again the current investigators conducted an ROC analysis to provide a specific cutoff value for oversizing. Use of this ratio in addition to the highly-reproducible areaderived sizing algorithm for SAPIEN-series valve selection may provide an added reassurance for minimizing PVL. The investigators demonstrate that a higher PVL score is correlated with a substantial increase in the incidence of significant PVL. However, it is important to recognize that the sensitivity of the PVL score is Conflict of interest: Nothing to report. *Correspondence to: E. Murat Tuzcu, Cleveland Clinic, Cardiovascular Medicine, 9500 Euclid Ave, Desk J3-6, Cleveland, OH 44195. E-mail: [email protected] Received 12 May 2015; Revision accepted 19 May 2015 DOI: 10.1002/ccd.26066 Published online 18 June 2015 in Wiley Online Library (wileyonlinelibrary.com)
Predicting Paravalvular Leak
marginal (40.9% for PVL score of 1 or 2), despite the specificity of 90.3% for a PVL score of 2. This is an important reminder that operators should conduct a thorough analysis of a patient’s anatomic features including calcium volume and distribution, adverse root characteristics such as leaflet asymmetry/fusion, and also keep in mind procedural-factors such as valve implantation depth. In direct contradistinction to SAVR, valve sizing and selection for patients undergoing TAVR is based on noninvasive image analysis. Therefore, numerous objective and some subjective methods of analysis should be employed to optimize treatment efficacy and safety. With this goal in mind, Watanabe and colleagues provide valuable insights into the effect of valve sizing and calcification on the incidence of PVL using the 1st and 2nd generation Edwards SAPIEN valve. They also suggest that these predictors may affect not only valve sizing, but also TAVR prosthesis selection. However, it is important to recognize that the parameters herein may not be applicable to the third-generation SAPIEN-3 valve (that is currently in widespread use in Europe and under clinical trial use in the US) due to its distinct design to minimize PVL.
153
REFERENCES 1. 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. 2. Khalique OK, Hahn RT, Gada H, Nazif TM, Vahl TP, George I, Kalesan B, Forster M, Williams MB, Leon MB, Einstein AJ, Pulerwitz TC, Pearson GD, Kodali SK. 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. JACC Cardiovasc Interv 2014;7:885–894. 3. Barbanti M, Yang TH, Rodes Cabau J, Tamburino C, Wood DA, Jilaihawi H, Blanke P, Makkar RR, Latib A, Colombo A, Tarantini G, Raju R, Binder RK, Nguyen G, Freeman M, Ribeiro HB, Kapadia S, Min J, Feuchtner G, Gurtvich R, Alqoofi F, Pelletier M, Ussia GP, Napodano M, de Brito FS Jr., Kodali S, Norgaard BL, Hansson NC, Pache G, Canovas SJ, Zhang H, Leon MB, Webb JG, Leipsic J. Anatomical and procedural features associated with aortic root rupture during balloon-expandable transcatheter aortic valve replacement. Circulation 2013;128:244–253. 4. Jilaihawi H, Kashif M, Fontana G, Furugen A, Shiota T, Friede G, Makhija R, Doctor N, Leon MB, Makkar RR. Cross-sectional computed tomographic assessment improves accuracy of aortic annular sizing for transcatheter aortic valve replacement and reduces the incidence of paravalvular aortic regurgitation. J Am Coll Cardiol 2012;59:1275–1286.
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
Editorial Comment Predicting Paravalvular Leak after Balloon-Expandable TAVR Amar Krishnaswamy, MD, and E. Murat Tuzcu,* MD Department of Cardiovascular Medicine, Heart and Vascular Institute, Cleveland Clinic, Cleveland, OH
Key Points
Objective measurement of a Valve Calcification Index (calcium volume/BSA) may predict PVL after TAVR using a cutoff value > 418 mm3/mm2 Oversizing the balloon-expandable SAPIEN valve with a goal ratio of valve diameter: average annulus diameter > 1.055 may reduce PVL after TAVR Single parameters are unlikely to provide adequate sensitivity to reduce PVL; a thorough analysis of root sizing, calcification, and morphology is important to balloon-expandable TAVR safety and efficacy
Paravalvular leak (PVL) after transcatheter aortic valve replacement (TAVR) is an important source of morbidity and mortality [1]. As we provide TAVR to younger patients and those at intermediate surgical risk, it is even more important that we optimize this procedure’s safety and efficacy in comparision to the historic gold standard of surgical aortic valve replacement (SAVR). Therefore, proper valve sizing and selection is of paramount importance in the preprocedural planning for TAVR. Watanabe and colleagues in this issue aimed to identify CT-derived predictors of PVL after implantation of the balloon-expandable Edwards SAPIEN series of valves. Among 545 consecutive, high-risk patients undergoing TAVR between 2009 and 2012, 176 patients underwent SAPIEN valve implantation and had a CT available. Various parameters of the aortic root were evaluated with respect to annulus and valve sizing, as well as calcification of the aortic root complex. After multivariate analysis, the valve calcification index [VCI; calcification volume (mm3)/body surface area (mm2)] of the aortic root (OR 1.002) and valve diC 2015 Wiley Periodicals, Inc. V
ameter/calculated average annulus diameter (CAAD) (OR 0.683) emerged as the major predictors of PVL 2. Specifically, receiver-operating curve (ROC) analysis demonstrated cutoff values for PVL 2 of VCI > 418 mm3/mm2 and VD/CAAD < 1.055. The investigators further created a “PVL Score,” assigning 1-point to each of these parameters, and demonstrated an incidence of PVL 2 of 5.3%, 11.8%, and 37.5% for PVL scores of 0, 1, and 2, respectively. Calcification of the aortic root complex is an important predictor of PVL, and also predicts annular rupture in patients undergoing SAPIEN valve implantation [2,3]. The current investigation aimed to further the available body of evidence in this regard by providing a specific cutoff value of the VCI to best predict significant PVL. It is important to note, however, that calcium attenuation is not always consistent across scans, which may limit the widespread applicability of this single number. However, a systematic calcification analysis that provides the VCI in addition to important factors such calcium location and distribution may be beneficial as an adjunctive parameter to use in optimizing valve sizing and selection and reducing the risk of annular trauma. Similarly, prior investigations have demonstrated the importance of CT-guided valve-oversizing to reduce the incidence of important PVL, as well as its contribution to annular rupture [4]. In this regard, again the current investigators conducted an ROC analysis to provide a specific cutoff value for oversizing. Use of this ratio in addition to the highly-reproducible areaderived sizing algorithm for SAPIEN-series valve selection may provide an added reassurance for minimizing PVL. The investigators demonstrate that a higher PVL score is correlated with a substantial increase in the incidence of significant PVL. However, it is important to recognize that the sensitivity of the PVL score is Conflict of interest: Nothing to report. *Correspondence to: E. Murat Tuzcu, Cleveland Clinic, Cardiovascular Medicine, 9500 Euclid Ave, Desk J3-6, Cleveland, OH 44195. E-mail: [email protected] Received 12 May 2015; Revision accepted 19 May 2015 DOI: 10.1002/ccd.26066 Published online 18 June 2015 in Wiley Online Library (wileyonlinelibrary.com)
Predicting Paravalvular Leak
marginal (40.9% for PVL score of 1 or 2), despite the specificity of 90.3% for a PVL score of 2. This is an important reminder that operators should conduct a thorough analysis of a patient’s anatomic features including calcium volume and distribution, adverse root characteristics such as leaflet asymmetry/fusion, and also keep in mind procedural-factors such as valve implantation depth. In direct contradistinction to SAVR, valve sizing and selection for patients undergoing TAVR is based on noninvasive image analysis. Therefore, numerous objective and some subjective methods of analysis should be employed to optimize treatment efficacy and safety. With this goal in mind, Watanabe and colleagues provide valuable insights into the effect of valve sizing and calcification on the incidence of PVL using the 1st and 2nd generation Edwards SAPIEN valve. They also suggest that these predictors may affect not only valve sizing, but also TAVR prosthesis selection. However, it is important to recognize that the parameters herein may not be applicable to the third-generation SAPIEN-3 valve (that is currently in widespread use in Europe and under clinical trial use in the US) due to its distinct design to minimize PVL.
153
REFERENCES 1. 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. 2. Khalique OK, Hahn RT, Gada H, Nazif TM, Vahl TP, George I, Kalesan B, Forster M, Williams MB, Leon MB, Einstein AJ, Pulerwitz TC, Pearson GD, Kodali SK. 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. JACC Cardiovasc Interv 2014;7:885–894. 3. Barbanti M, Yang TH, Rodes Cabau J, Tamburino C, Wood DA, Jilaihawi H, Blanke P, Makkar RR, Latib A, Colombo A, Tarantini G, Raju R, Binder RK, Nguyen G, Freeman M, Ribeiro HB, Kapadia S, Min J, Feuchtner G, Gurtvich R, Alqoofi F, Pelletier M, Ussia GP, Napodano M, de Brito FS Jr., Kodali S, Norgaard BL, Hansson NC, Pache G, Canovas SJ, Zhang H, Leon MB, Webb JG, Leipsic J. Anatomical and procedural features associated with aortic root rupture during balloon-expandable transcatheter aortic valve replacement. Circulation 2013;128:244–253. 4. Jilaihawi H, Kashif M, Fontana G, Furugen A, Shiota T, Friede G, Makhija R, Doctor N, Leon MB, Makkar RR. Cross-sectional computed tomographic assessment improves accuracy of aortic annular sizing for transcatheter aortic valve replacement and reduces the incidence of paravalvular aortic regurgitation. J Am Coll Cardiol 2012;59:1275–1286.
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
