Management and Outcome of Residual Aortic Regurgitation After Transcatheter Aortic Valve Implantation

Management and Outcome of Residual Aortic Regurgitation After Transcatheter Aortic Valve Implantation Edward Koifman, MD, Romain Didier, MD, Hector Garcia-Garcia, MD, PhD, Gaby Weissman, MD, Andrew W. Ertel, MD, Sarkis Kiramijyan, MD, Arie Steinvil, MD, Toby Rogers, MD, Nirav Patel, MD, Sandeep Kumar, MD, Arpi Tavil-Shatelyan, BA, Itsik Ben-Dor, MD, Augusto D. Pichard, MD, Rebecca Torguson, MPH, Jiaxiang Gai, MSPH, Lowell F. Satler, MD, and Ron Waksman, MD* We aimed to evaluate the success rates of balloon valvuloplasty post-dilation (BVPD) and a second-valve deployment in reducing residual aortic regurgitation (AR) after transcatheter aortic valve implantation (TAVI) and its impact on outcome. Residual AR immediately post-TAVI in patients with aortic stenosis is a common condition that adversely affects outcome. Patients who underwent TAVI who had more-than-mild residual AR were managed either with medical therapy, re-intervention with BVPD, or a second valve. The clinical impact of these strategies was evaluated, and the anatomical features of patients with successful and unsuccessful intervention were compared. Among 572 patients with TAVI, 110 (19%) had significant residual AR after initial device deployment. Sixty patients were treated by BVPD (n [ 49) or second-device deployment (n [ 11), whereas 50 patients were treated medically. Successful reduction in residual AR to mild and below was achieved in 56% of the intervention group. Eccentric and calcified annuli were present in patients in whom residual AR remained despite re-intervention (p [ 0.004). Interventions to reduce residual AR were independently associated with improved survival compared with conservative medical therapy (hazard ratio 0.45, 95% confidence interval 0.94 to 0.21, p [ 0.03). BVPD or a second valve were safe and were not associated with increased rate of periprocedural complications. In conclusion, both BVPD and a second-valve deployment to reduce residual AR post-TAVI are effective and safe. The success rates are inversely correlated with the annulus eccentricity and calcification. These measures should be encouraged to reduce acute residual AR as they are associated with improved long-term survival. Ó 2017 Published by Elsevier Inc. (Am J Cardiol 2017;120:632e639) Aortic regurgitation (AR) post-transcatheter aortic valve implantation (TAVI) is a frequent complication1,2 and has a detrimental impact on patient outcome with increased mortality rate among patients with TAVI with significant residual AR (greater than mild).3 Prevention of post-TAVI AR requires careful planning that includes proper annular imaging for device sizing and projection angle for positioning. Treatment options for AR post-TAVI include balloon valvuloplasty post-dilation (BVPD), second-valve implantation, snaring of the valve to improve positioning, and vascular plugs.4,5 Previous studies have shown potential for increased rates of stroke and no impact on survival rates.6,7 The aim of this study was to assess the success rate of various techniques in managing residual AR, along with exploration of the anatomical and procedural correlates of success, and finally to evaluate the impact of these

Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC. Manuscript received March 17, 2017; revised manuscript received and accepted May 16, 2017. See page 638 for disclosure information. *Corresponding author: Tel: (202) 877-2812; fax: (202) 877-2715. E-mail address: [email protected] (R. Waksman). 0002-9149/17/$ - see front matter Ó 2017 Published by Elsevier Inc. http://dx.doi.org/10.1016/j.amjcard.2017.05.033

techniques on early and late outcomes in patients with severe aortic stenosis (AS) who underwent TAVI. Methods Consecutive patients with severe symptomatic AS who underwent TAVI from May 2007 to April 2015 at our institution were included in the present study. Patients with more-than-mild residual AR post-initial device deployment were categorized according to conservative medical management or immediate re-intervention with BVPD or a second-device deployment. Patients with initial device embolization were excluded from this study. The decision whether to use further means to reduce residual AR was according to the operator’s discretion. Prespecified clinical, procedural, and laboratory data were prospectively collected for all patients during screening, on admission, immediately postprocedure, and during follow-up. The data collection was approved by the local institutional review board. This included demographic information, medical history, clinical data, imaging, and laboratory indexes. Procedural data collected in the database included the amount of contrast-injected, procedural length devices used for valve implantation, which comprised first-generation Sapien, Sapien XT and Sapien 3 www.ajconline.org

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Figure 1. Examples of annular calcification and eccentricity. The right panel shows annular dimensions of 25.5  29.5 mm, which results in an eccentricity index of 0.86 and a calcium score of 0 mm3. The patient was treated with balloon post-dilation, which resulted in a reduction of residual AR to minimal. The left panel shows annular dimensions of 20.8  26.8 mm, which results in an eccentricity index of 0.78 with a calcium score of 159 mm3. The patient was treated with balloon post-dilation which resulted in a residual AR of moderate severity.

(Edwards Lifesciences, Irvine, California), and CoreValve and Evolut (Medtronic, Minneapolis, Minnesota). Vascular access and immediate complications were also recorded in the database. Measurements of the aortic valve complex were performed according to the current recommendations8 by a retrospective electrocardiography-gated multislice computerized tomography with a 256-slice Philips CT scanner and a 0.625-mm detector collimation. High-resolution thin-cut transverse-plane images were reconstructed at <1-mm slice thickness using an iterative algorithm. Device sizing was based on manufacturer recommendations. Calcium volume quantification was performed with a dedicated software (3mensio Valves, version 7; Pie Medical Imaging, Maastricht, The Netherlands) and was categorized to annular and left ventricular outflow tract calcium defined from the leaflets attachment level down to 5 mm below and to valvular calcium defined as any calcium above the attachment level (Figure 1). Eccentricity was calculated as the ratio of short and long diameter. Residual AR severity was determined by both aortography, using the Sellers method,9 and transthoracic echocardiography by an experienced imaging cardiologist per the updated Valve Academic Research Consortium (VARC)-2 criteria10 and by evaluation of the valve circumference

involved,11 mild (<10%), moderate (10% to 20%), and severe (>20%). Sizing of the balloon for post-dilation relied on angiographic measurement of the initial valve expansion using Quantitative Angiography tools from Phillips Xper system. Sizing of the second device was based on initial annular measurements. Postprocedural data used hospital documents as a primary source for laboratory results, length of stay, and in-hospital complications. Follow-up office visits were conducted at 30 days and 12 months. Clinical events were adjudicated according to the updated VARC-2 criteria by an independent cardiologist who determined the nature of the event. Continuous variables are expressed as mean
SD and compared using a Student’s t test or median (interquartile range) with Mann-Whitney U test comparison according to the distribution. Categorical variables are expressed as numbers and percentages and compared using a chi-square or Fisher’s exact test as appropriate. Stepwise multivariate Cox proportional hazard ratio regression models were performed to adjust for significant differences in baseline characteristics and between the groups and clinically relevant factors including age, gender, New York Heart Association class, renal insufficiency, STS score, previous valvuloplasty, and valve type. Statistical analysis was performed using SAS,

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Figure 2. Study flow chart.

Table 1 Baseline characteristics of transcatheter aortic valve replacement patients with conservative medical and interventional treatments to reduce residual aortic regurgitation following initial device deployment Variable

Medical (n¼50)

Intervention (n¼60)

p value

Age, (years) Men Black Body mass index, (Kg/m2) Hypertension Diabetes Mellitus Hyperlipidemia Prior cerebrovascular disease Chronic lung disease Glomerular filtration rate < 60 ml/min Atrial Fibrillation Pacemaker Peripheral vascular disease Prior percutaneous coronary intervention Prior coronary bypass Prior myocardial infarction STS score “Porcelain” Aorta Prior balloon valvuloplasty Hemoglobin (g/L) Creatinine (mg/dL) Echocardiography Left ventricle ejection fraction<40% Pulmonary artery systolic pressure, (mmHg) Aortic valve area, (cm2) Indexed aortic valve area, (cm2/m2) Mean gradient, (mmHg) Mitral regurgitation > 2 Left atrial diameter, (cm)

83
8 31 (63%) 11 (24%) 26
6 44 (90%) 18 (37%) 39 (81%) 8 (17%) 16 (33%) 34 (71%) 26 (53%) 15 (35%) 20 (41%) 16 (33%) 20 (41%) 12 (26%) 10.6
4.9 7 (14%) 12 (30%) 11.1
1.8 1.4
0.8

83
7 39 (66%) 10(18%) 26
6 53 (95%) 19 (35%) 46 (84%) 3 (6%) 21 (38%) 26 (46%) 21 (38%) 14 (36%) 26 (49%) 17 (31%) 16 (29%) 13 (24%) 7.6
4.0 3 (5%) 11 (22%) 11.5
1.8 1.4
1.3

0.87 0.76 0.48 0.89 0.47 0.82 0.75 0.08 0.6 0.02 0.11 0.92 0.4 0.85 0.21 0.82 <0.001 0.18 0.39 0.28 0.95

15 (32%) 49
11 0.7
0.1 0.4
0.1 47
12 6 (16%) 4.8
0.8

17 (29%) 42
14 0.7
0.1 0.4
0.1 48
14 8 (15%) 4.6
1

0.77 0.02 0.63 0.89 0.63 1 0.35

STS ¼ Society of Thoracic Surgeons.

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Figure 3. Rates of medical conservative therapy and re-intervention among patients with severe AS who underwent TAVI by year. Table 3 Procedural complications

Table 2 Procedural characteristics Variable

Medical (n¼50)

Intervention (n¼60)

p value

General anesthesia Transfemoral access Rapid Pacing Fluoroscopy time, (min) Contrast Volume, (ml) Balloon expandable Self expandable

13 (26%) 42 (84%) 48 (96%) 20
9 112
48 44 (88%) 6 (12%)

10 (17%) 54 (90%) 60 (100%) 33
40 150
71 38 (63%) 22 (37%)

0.23 0.35 0.2 0.02 0.001 0.002 0.002

version 8.2 (SAS Institute Inc, Cary, North Carolina), and p value <0.05 was considered statistically significant. Results Among 572 patients with TAVI, 110 (19%) had morethan-mild residual AR after initial device deployment. Sixty patients were treated by BVPD or second-device deployment, whereas 50 patients were treated medically (Figure 2). Table 1 lists the baseline characteristics of each group and reveals a higher rate of renal insufficiency defined as glomerular filtration rate <60 mL/min/1.73 m2 in patients treated conservatively, along with higher STS score, and pulmonary artery systolic pressure by echo. Residual AR after balloon-expandable device was less likely to be intervened on than self-expanding device, which could be explained by the later approval of the self-expanding device and more aggressive treatment in recent years (Figure 3). Procedural characteristics (Table 2) list a higher rate of initial balloon valvuloplasty in the conservatively treated

Variable Major vascular complication Stroke Life threatening bleeding Transfusion Pleural/Pericardial Effusion Acute kidney injury2 Pacemaker implantation Left bundle branch block Atrial Fibrillation Residual aortic regurgitation>mild Complete heart block

Medical (n¼50) 6 1 4 24 5 10 3 6 6 50 3

(12%) (2%) (8%) (48%) (10%) (21%) (6%) (13%) (12%) (100%) (6%)

Intervention (n¼60) 7 2 3 23 3 6 7 14 12 25 5

(12%) (3%) (5%) (38%) (5%) (13%) (12%) (26%) (20%) (44%) (8%)

p value 0.97 1 0.7 0.31 0.47 0.41 0.34 0.11 0.26 <0.001 0.73

group, whereas patients with re-interventions had longer fluoroscopy time and higher contrast volume. Among the 60 patients who underwent re-intervention, BVPD alone was used in 49 patients (82%) and a second valve was deployed in 11 patients (18%). There was no difference in vascular complication, bleeding rates, or kidney injury between patients with and without re-intervention (Table 3). Reduction in residual AR to mild severity or less at discharge was noted in 56% of the patients in the re-intervention group. Anatomical features were available in 55 patients from the re-intervention group (Table 4). Annular eccentricity >0.8 was found to be the only significant anatomic parameter for successful reduction in residual AR (50% vs 21%, p ¼ 0.04), whereas annular and left ventricular outflow tract calcification of <50 mm3 had a trend toward successful reduction in residual AR (83% vs 57%, p ¼

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Table 4 Anatomical and procedural features associated with successful and unsuccessful reduction residual aortic regurgitation Variable Area, (mm2) Perimeter, mm Eccentricity<0.8 Balloon expandable Implantation depth>6 mm Device oversizing Reballoon to valve ratio Valvular calcium > 300 mm3 Annular and LVOT calcium >50 mm3

Residual AR>mild n¼25

Residual ARMild n¼35

p-value

484
101 75
15 13 (50%) 19 (76%) 8 (21%) 1.16
0.11 0.92
0.09 11 (48%) 4 (17%)

461
78 78
8 19 (79%) 21 (60%) 7 (18%) 11.7
0.17 0.94
0.07 17 (71%) 10 (44%)

0.38 0.33 0.04 0.27 1 0.34 0.33 0.14 0.06

AR ¼ aortic regurgitation; LVOT ¼ left ventricular outflow tract.

Figure 4. Correlation of annular and outflow tract calcification and eccentricity with successful reduction of residual AR.

0.06). The interaction of annular eccentricity and calcification is shown in Figure 4, demonstrating failure to achieved adequate reduction in residual AR 1 in virtually all patients with both eccentric and calcified aortic annulus, compared with w60% of patients achieving residual AR <1 in the rest of the groups (p ¼ 0.004). Interestingly, there was no statistically significant difference between balloon and self-expandable devices with regard to successful reduction in residual AR (p ¼ 0.27). Survival analysis of patients with residual AR after the initial device deployment (Figure 5) demonstrates a significant overall survival benefit for patients with reintervention (log-rank p value ¼ 0.03), which remained significant after adjustment for significant differences in baseline characteristics and clinically relevant factors (hazard ratio 0.45; 95% confidence interval 0.94 to 0.21; p ¼ 0.03). Subsequent comparison of patients with successful versus unsuccessful reduction of residual AR (Figure 6) reveals a statistically significant improvement in cumulative survival up to 1 year among in favor of the patients with successful residual AR reduction (log-rank p value ¼ 0.02). Discussion Despite improvements in TAVI technology and accuracy in valve sizing, significant residual AR after valve

implantation remains common and poses a therapeutic challenge. The present study demonstrates that significant residual AR after TAVI can be managed safely and effectively with BVPD and/or a second-valve implantation in more than half of the patients with greater-than-mild residual AR. Eccentric and calcified annuli are inversely associated with successful reduction of residual AR. Finally, successful treatment of the residual AR resulted in improvement in survival at 1 year compared with those who are managed with medical treatment alone. Residual AR after TAVI is a significant limitation of the procedure that adversely affects the outcome of patients with severe AS. Even mild residual AR has been reported to be associated with an increase in mortality,12 and there is a consensus that moderate and above AR is associated with an increase in mortality.13 Although TAVI and surgical aortic valve replacement had similar outcome in severe patients with AS at intermediate surgical risk,14 residual AR poses a substantial drawback for TAVI over surgical aortic valve replacement. Because survival in intermediate and low-risk severe patients with AS is expected to be longer than in the high-risk group, residual AR will have a greater impact in this subset of patients. Accordingly, a low threshold for treatment of residual AR is indicated after TAVI to minimize this phenomenon. As our study shows, this can be achieved with relatively simple techniques in more than half of the patients regardless of valve type. Although BVPD and a second were shown to adequately reduce residual AR in a substantial proportion of patients with TAVI,7,15e19 several reports raised concerns regarding higher risk of cerebrovascular events,20,21 annulus rupture, and mortality.6,22 These adverse events could be related to the condition leading to re-intervention, increased procedure time, higher contrast volume used, along with the hemodynamic consequence of residual AR. Improvement in sizing and device design has reduced the occurrence of residual AR.23 Imaging of residual AR helped to better delineate the phenomenon and facilitated a better understanding of the factors associated with it, but accurate quantification of residual AR is still a challenge.16,24e27 Overall survival benefit of interventions to reduce residual AR was not clear according to previous reports. In that sense, this study demonstrates the survival benefit of AR reduction, despite the previously reported risk involved in such measures. Moreover, we have found no additional

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Figure 5. Kaplan-Meier of patients with residual AR after TAVI according to medical conservative therapy or re-intervention.

Figure 6. Kaplan-Meier of patients with residual AR who underwent additional intervention to reduce the severity of the leak according to the final result.

adverse events in the re-intervention group despite longer procedural time and higher contrast volume used. Our method for sizing the balloon for post-dilation takes into account a degree of underexpansion of the initial device, which can potentially mitigate the risks of annular rupture and tissue damage leading to conduction defects, coronary artery occlusion, and initial device embolization, while facilitating increased and symmetrical expansion. A seconddevice deployment can reduce the residual AR by sealing leaks that are caused by improper position inadequate radial strength and asymmetric expansion of self-expandable devices. However, delivery of the device should be performed carefully without damaging or embolizing the initial device,

while taking into account possible occlusion of the coronary arteries especially in patients with low coronary takeoff, high initial implantation, and small aortic root. The success of BVPD and a second-device deployment may be limited in patients with eccentric and calcified annulus, measured using contemporary methods for quantification of calcium load.28 This concurs with previous reports of factors associated with residual AR.29,30 Nonetheless, although previous reports showed higher rates of residual AR with self-expandable devices,21 our study shows that the success of reduction in AR is similar regardless of valve type. These findings point toward the unmet need for percutaneous calcium treatment devices, which can mitigate the incidence of residual AR and facilitate improved outcome for patients with severe AS. Our study has several limitations, which must be taken into consideration when interpreting the results. First, this is a retrospective analysis of a prospective cohort from a single center. Second, we included patients from the start of the TAVI program until recently, and as data consistently showed the adverse effect of residual AR in patients with TAVI, operators may have acted more aggressively to reduce it. Third, because no core laboratory was involved in the study, we primarily relied on echocardiographic and CT reports from the patient medical charts, which could be inaccurate. Fourth, some of the devices used were from an older generation, and therefore, our analysis may differ if only new-generation devices were included. In conclusion, our study demonstrates that residual AR can be reduced in >50% of patients with severe AS who underwent TAVI with more-than-mild AR severity. This can be achieved with relatively simple measures such as BVPD or a second-valve deployment, without additional

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complications and with a potential improvement in the 1year survival.

Disclosures Dr. Waksman: Consultant: Abbott Vascular, Amgen, Biosensors International, Biotronik, Boston Scientific, Corindus, Lifetech Medical, Medtronic Vascular, Philips Volcano, Symetis; Speakers Bureau: AstraZeneca; grant support: Biosensors International, Biotronik, Boston Scientific, Edwards Lifesciences, and Abbott Vascular. The other authors do not have any conflicts to disclose. 1. Gilard M, Eltchaninoff H, Iung B, Donzeau-Gouge P, Chevreul K, Fajadet J, Leprince P, Leguerrier A, Lievre M, Prat A, Teiger E, Lefevre T, Himbert D, Tchetche D, Carrie D, Albat B, Cribier A, Rioufol G, Sudre A, Blanchard D, Collet F, Dos Santos P, Meneveau N, Tirouvanziam A, Caussin C, Guyon P, Boschat J, Le Breton H, Collart F, Houel R, Delpine S, Souteyrand G, Favereau X, Ohlmann P, Doisy V, Grollier G, Gommeaux A, Claudel JP, Bourlon F, Bertrand B, Van Belle E, Laskar M; FRANCE 2 Investigators. Registry of transcatheter aortic-valve implantation in highrisk patients. N Engl J Med 2012;366:1705e1715. 2. Mack MJ, Brennan JM, Brindis R, Carroll J, Edwards F, Grover F, Shahian D, Tuzcu EM, Peterson ED, Rumsfeld JS, Hewitt K, Shewan C, Michaels J, Christensen B, Christian A, O’Brien S, Holmes D; STS/ACC TVT Registry. Outcomes following transcatheter aortic valve replacement in the United States. JAMA 2013;310: 2069e2077. 3. 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;61:1585e1595. 4. Genereux P, Head SJ, Hahn R, Daneault B, Kodali S, Williams MR, van Mieghem NM, Alu MC, Serruys PW, Kappetein AP, Leon MB. Paravalvular leak after transcatheter aortic valve replacement: the new Achilles’ heel? A comprehensive review of the literature. J Am Coll Cardiol 2013;61:1125e1136. 5. Lerakis S, Hayek SS, Douglas PS. Paravalvular aortic leak after transcatheter aortic valve replacement: current knowledge. Circulation 2013;127:397e407. 6. Hahn RT, Pibarot P, Webb J, Rodes-Cabau J, Herrmann HC, Williams M, Makkar R, Szeto WY, Main ML, Thourani VH, Tuzcu EM, Kapadia S, Akin J, McAndrew T, Xu K, Leon MB, Kodali SK. Outcomes with post-dilation following transcatheter aortic valve replacement: the PARTNER I trial (Placement of Aortic Transcatheter Valve). JACC Cardiovasc Interv 2014;7:781e789. 7. Ussia GP, Barbanti M, Ramondo A, Petronio AS, Ettori F, Santoro G, Klugmann S, Bedogni F, Maisano F, Marzocchi A, Poli A, Napodano M, Tamburino C. The valve-in-valve technique for treatment of aortic bioprosthesis malposition an analysis of incidence and 1-year clinical outcomes from the Italian CoreValve registry. J Am Coll Cardiol 2011;57:1062e1068. 8. Achenbach S, Delgado V, Hausleiter J, Schoenhagen P, Min JK, Leipsic JA. SCCT expert consensus document on computed tomography imaging before transcatheter aortic valve implantation (TAVI)/ transcatheter aortic valve replacement (TAVR). J Cardiovasc Comput Tomogr 2012;6:366e380. 9. Sellers RD, Levy MJ, Amplatz K, Lillehei CW. Left retrograde cardioangiography in acquired cardiac disease: technic, indications and interpretations in 700 cases. Am J Cardiol 1964;14:437e447. 10. Kappetein AP, Head SJ, Genereux P, Piazza N, van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA, Hahn RT, Kirtane AJ, Krucoff MW, Kodali S, Mack MJ, Mehran R, RodesCabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. J Am Coll Cardiol 2012;60:1438e1454.

11. Zoghbi WA, Chambers JB, Dumesnil JG, Foster E, Gottdiener JS, Grayburn PA, Khandheria BK, Levine RA, Marx GR, Miller FA Jr, Nakatani S, Quinones MA, Rakowski H, Rodriguez LL, Swaminathan M, Waggoner AD, Weissman NJ, Zabalgoitia M; American Society of Echocardiography’s Guidelines and Standards Committee, Task Force on Prosthetic Valves, American College of Cardiology Cardiovascular Imaging Committee, Cardiac Imaging Committee of the American Heart Association, European Association of Echocardiography, European Society of Cardiology, Japanese Society of Echocardiography, Canadian Society of Echocardiography, American College of Cardiology Foundation, American Heart Association, European Association of Echocardiography, European Society of Cardiology, Japanese Society of Echocardiography, Canadian Society of Echocardiography. Recommendations for evaluation of prosthetic valves with echocardiography and Doppler ultrasound: a report from the American Society of Echocardiography’s Guidelines and Standards Committee and the Task Force on prosthetic valves, developed in conjunction with the American College of Cardiology Cardiovascular Imaging Committee, Cardiac Imaging Committee of the American Heart Association, the European Association of Echocardiography, a registered branch of the European Society of Cardiology, the Japanese Society of Echocardiography and the Canadian Society of Echocardiography, endorsed by the American College of Cardiology Foundation, American Heart Association, European Association of Echocardiography, a registered branch of the European Society of Cardiology, the Japanese Society of Echocardiography, and Canadian Society of Echocardiography. J Am Soc Echocardiogr 2009;22:975e1014; quiz 1082e1084. 12. 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 aorticvalve replacement. N Engl J Med 2012;366:1686e1695. 13. Otto CM, Kumbhani DJ, Alexander KP, Calhoon JH, Desai MY, Kaul S, Lee JC, Ruiz CE, Vassileva CM. 2017 ACC expert consensus decision pathway for transcatheter aortic valve replacement in the management of adults with aortic stenosis: a report of the American College of Cardiology Task Force on clinical expert consensus documents. J Am Coll Cardiol 2017;69:1313e1346. 14. Leon MB, Smith CR, Mack MJ, Makkar RR, Svensson LG, Kodali SK, Thourani VH, Tuzcu EM, Miller DC, Herrmann HC, Doshi D, Cohen DJ, Pichard AD, Kapadia S, Dewey T, Babaliaros V, Szeto WY, Williams MR, Kereiakes D, Zajarias A, Greason KL, Whisenant BK, Hodson RW, Moses JW, Trento A, Brown DL, Fearon WF, Pibarot P, Hahn RT, Jaber WA, Anderson WN, Alu MC, Webb JG; PARTNER 2 Investigators. Transcatheter or surgical aorticvalve replacement in intermediate-risk patients. N Engl J Med 2016;374:1609e1620. 15. Takagi K, Latib A, Al-Lamee R, Mussardo M, Montorfano M, Maisano F, Godino C, Chieffo A, Alfieri O, Colombo A. Predictors of moderate-to-severe paravalvular aortic regurgitation immediately after CoreValve implantation and the impact of postdilatation. Catheter Cardiovasc Interv 2011;78:432e443. 16. Toggweiler S, Wood DA, Rodes-Cabau J, Kapadia S, Willson AB, Ye J, Cheung A, Leipsic J, Binder RK, Gurvitch R, Freeman M, Thompson CR, Svensson LG, Dumont E, Tuzcu EM, Webb JG. Transcatheter valve-in-valve implantation for failed balloonexpandable transcatheter aortic valves. JACC Cardiovasc Interv 2012;5:571e577. 17. Witkowski A, Jastrzebski J, Dabrowski M, Chmielak Z. Second transcatheter aortic valve implantation for treatment of suboptimal function of previously implanted prosthesis: review of the literature. J Interv Cardiol 2014;27:300e307. 18. Gerckens U, Latsios G, Mueller R, Buellesfeld L, John D, Yuecel S, Sauren B, Felderhof T, Iversen S, Grube E. Procedural and mid-term results in patients with aortic stenosis treated with implantation of 2 (in-series) CoreValve prostheses in 1 procedure. JACC Cardiovasc Interv 2010;3:244e250. 19. Stundl A, Rademacher MC, Descoups C, Weber M, Sedaghat A, Grube M, Hammerstingl C, Mellert F, Vasa-Nicotera M, Welz A, Grube E, Werner N, Nickenig G, Sinning JM. Balloon post-dilation and valve-in-valve implantation for the reduction of paravalvular

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20.

21.

22.

23.

24.

leakage with use of the self-expanding CoreValve prosthesis. EuroIntervention 2016;11:1140e1147. Nombela-Franco L, Rodes-Cabau J, DeLarochelliere R, Larose E, Doyle D, Villeneuve J, Bergeron S, Bernier M, Amat-Santos IJ, Mok M, Urena M, Rheault M, Dumesnil J, Cote M, Pibarot P, Dumont E. Predictive factors, efficacy, and safety of balloon postdilation after transcatheter aortic valve implantation with a balloon-expandable valve. JACC Cardiovasc Interv 2012;5: 499e512. Clerfond G, Pereira B, Innorta A, Motreff P, Gilard M, Laskar M, Eltchaninoff H, Iung B, Leprince P, Teiger E, Chevreul K, Prat A, Lievre M, Leguerrier A, Donzeau-Gouge P, Fajadet J, Souteyrand G. Comparison of outcomes after one-versus-two transcatheter aortic valve implantation during a same procedure (from the France 2 registry). Am J Cardiol 2015;115:1273e1280. Makkar RR, Jilaihawi H, Chakravarty T, Fontana GP, Kapadia S, Babaliaros V, Cheng W, Thourani VH, Bavaria J, Svensson L, Kodali S, Shiota T, Siegel R, Tuzcu EM, Xu K, Hahn RT, Herrmann HC, Reisman M, Whisenant B, Lim S, Beohar N, Mack M, Teirstein P, Rihal C, Douglas PS, Blackstone E, Pichard A, Webb JG, Leon MB. Determinants and outcomes of acute transcatheter valve-invalve therapy or embolization: a study of multiple valve implants in the U.S. PARTNER trial (Placement of AoRTic TraNscathetER Valve Trial Edwards SAPIEN Transcatheter Heart Valve). J Am Coll Cardiol 2013;62:418e430. 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: 1275e1286. Sherif MA, Abdel-Wahab M, Stocker B, Geist V, Richardt D, Tolg R, Richardt G. Anatomic and procedural predictors of paravalvular aortic regurgitation after implantation of the Medtronic CoreValve bioprosthesis. J Am Coll Cardiol 2010;56:1623e1629.

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25. Sinning JM, Hammerstingl C, Vasa-Nicotera M, Adenauer V, Lema Cachiguango SJ, Scheer AC, Hausen S, Sedaghat A, Ghanem A, Muller C, Grube E, Nickenig G, Werner N. Aortic regurgitation index defines severity of peri-prosthetic regurgitation and predicts outcome in patients after transcatheter aortic valve implantation. J Am Coll Cardiol 2012;59:1134e1141. 26. Gripari P, Ewe SH, Fusini L, Muratori M, Ng AC, Cefalu C, Delgado V, Schalij MJ, Bax JJ, Marsan NA, Tamborini G, Pepi M. Intraoperative 2D and 3D transoesophageal echocardiographic predictors of aortic regurgitation after transcatheter aortic valve implantation. Heart 2012;98:1229e1236. 27. Zamorano JL, Badano LP, Bruce C, Chan KL, Goncalves A, Hahn RT, Keane MG, La Canna G, Monaghan MJ, Nihoyannopoulos P, Silvestry FE, Vanoverschelde JL, Gillam LD. EAE/ASE recommendations for the use of echocardiography in new transcatheter interventions for valvular heart disease. Eur Heart J 2011;32: 2189e2214. 28. Jilaihawi H, Makkar RR, Kashif M, Okuyama K, Chakravarty T, Shiota T, Friede G, Nakamura M, Doctor N, Rafique A, Shibayama K, Mihara H, Trento A, Cheng W, Friedman J, Berman D, Fontana GP. A revised methodology for aortic-valvar complex calcium quantification for transcatheter aortic valve implantation. Eur Heart J Cardiovasc Imaging 2014;15:1324e1332. 29. Rodriguez-Olivares R, El Faquir N, Rahhab Z, Geeve P, Maugenest AM, van Weenen S, Ren B, Galema T, Geleijnse M, Van Mieghem NM, van Domburg R, Bruining N, Schultz C, Lauritsch G, de Jaegere PP. Does frame geometry play a role in aortic regurgitation after Medtronic CoreValve implantation? EuroIntervention 2016;12: 519e525. 30. Rodriguez-Olivares R, Rahhab Z, Faquir NE, Ren B, Geleijnse M, Bruining N, van Mieghem NM, Schultz C, Lauritsch G, de Jaegere PP. Differences in frame geometry between balloonexpandable and self-expanding transcatheter heart valves and association with aortic regurgitation. Rev Esp Cardiol (Engl Ed) 2016;69:392e400.