Relation Between Left Ventricular Outflow Tract Calcium and Mortality Following Transcatheter Aortic Valve Implantation

Relation Between Left Ventricular Outflow Tract Calcium and Mortality Following Transcatheter Aortic Valve Implantation Yoshio Maeno, MD, PhDa, Yigal Abramowitz, MDa, Sung-Han Yoon, MDa, Sharjeel Israr, MDa, Hasan Jilaihawi, MDb, Yusuke Watanabe, MDc, Rahul Sharma, MDa, Hiroyuki Kawamori, MD, PhDa, Masaki Miyasaka, MDa, Yoshio Kazuno, MDa, Nobuyuki Takahashi, MDa, Babak Hariri, MDa, Geeteshwar Mangat, MDa, Mohammad Kashif, MDa, Tarun Chakravarty, MDa, Mamoo Nakamura, MDa, Wen Cheng, MDa, and Raj R. Makkar, MDa,* Left ventricular outflow tract (LVOT) calcium is known to be associated with adverse procedural outcomes after transcatheter aortic valve implantation (TAVI), yet its effect on midterm outcomes has not been previously investigated. The aim of this study was to determine the influence of LVOT calcium on 2-year mortality after TAVI. A total of 537 consecutive patients underwent TAVI and 2 groups were established, stratified based on the severity of the LVOT calcium. The primary outcome was 2-year overall survival rate. The ≥moderate LVOT calcium group included 107 patients (19.9%) and the remaining 430 patients (80.1%) were included in the ≤mild LVOT calcium group. After a median followup of 717 days (interquartile range 484 to 828), the Kaplan-Meier analysis revealed that the 2-year overall survival probability was significantly lower in the ≥moderate LVOT calcium group than in the ≤mild LVOT calcium group (log-rank p = 0.001). On a Cox hazard model, ≥moderate LVOT calcium was associated with increased all-cause mortality after TAVI (hazard ratio 1.74, p = 0.009). In the subgroup analysis, based on valve designs, SAPIEN 3-TAVI done in the setting of ≥moderate LVOT calcium had a relatively similar survival probability as those of ≤mild LVOT calcium (log-rank p = 0.18), which is in contrast with older generation valves (log-rank p = 0.001). In conclusion, patients with ≥moderate LVOT calcium were shown to have a lower survival probability in the midterm follow-up after TAVI, compared with those with ≤mild LVOT calcium. Patients with high-grade LVOT calcium should be monitored with longer-term follow-ups after TAVI. © 2017 Elsevier Inc. All rights reserved. (Am J Cardiol 2017;120:2017–2024) Many trials have established the safety and efficacy of transcatheter aortic valve implantation (TAVI), as well as the early and long-term outcomes after TAVI.1–9 In addition, various studies have identified baseline clinical and echocardiographic predictors associated with long-term patient outcomes.2,4–13 Left ventricular outflow tract (LVOT) calcium is frequently encountered in computed tomography imaging before TAVI. Moreover, the degree of LVOT calcium has been shown to be predictive of various procedure-related complications after TAVI.14–18 However, the impact of LVOT calcium on midterm mortality after TAVI has not been studied. The aim of the present study was to determine the influence of LVOT calcium on midterm mortality after TAVI and to evaluate the interaction of SAPIEN 3 (S3) valve implantation in

a

Cedars-Sinai Medical Center, Heart Institute, Los Angeles, California; bMedicine and Cardiothoracic Surgery, New York University Langone Medical Center, New York, New York; and cDepartment of Cardiology, Teikyo University Hospital, Itabashi, Tokyo, Japan. Manuscript received April 16, 2017; revised manuscript received and accepted August 8, 2017. See page 2021 for disclosure information. *Corresponding author: Tel: (310) 423 3977; fax: (310) 423 0106. E-mail address: [email protected] (R.R. Makkar). 0002-9149/$ - see front matter © 2017 Elsevier Inc. All rights reserved. https://doi.org/10.1016/j.amjcard.2017.08.018

patients with ≥moderate LVOT calcium with midterm mortality. Methods In January 2013 to December 2014, 617 consecutive patients with severe aortic stenosis who had a preprocedural multidetector computed tomography (MDCT) underwent TAVI at our institution. All patients were considered at high risk for valve surgery by our institutional heart team. Thirty patients with previous bioprosthesis (30 patients) and those with noncontrast MDCT or poor computed tomography imaging quality (50 patients) were excluded from the initial analysis of this cohort. Implanted valves included Edwards SAPIEN/ SAPIEN XT/SAPIEN 3 (Edwards Lifesciences, Irvine, California) or CoreValve (Medtronic, Minneapolis, Minnesota). All patients underwent a multidisciplinary Heart Team evaluation before TAVI. The bioprosthesis size and type were determined from preprocedural MDCT or 3-dimensional transesophageal echocardiography findings; the latter was performed immediately before the procedure and the decision was made at the operator’s discretion. Clinical data, echocardiographic data, and procedural variables were prospectively recorded. The last date a patient was alive was derived from electronic health records, using information from www.ajconline.org

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office or telephone encounters. Aortic annulus measurements were performed using 3mensio Structural Heart software (3mensio Valves, version 7.2; Pie Medical Imaging, Maastricht, The Netherlands) by double-blinded cross check at the Cedars-Sinai core laboratory.19 The severity of LVOT calcium was also defined as (1) mild: 1 nodule of calcium extending <5 mm and covering <10% of the perimeter of the annulus; (2) moderate: 2 nodules, or 1 extending >5 mm or covering >10% of the perimeter of the annulus; and (3) severe: multiple nodules, or a single focus extending >1 cm in length or covering >20% of the perimeter of the annulus17,18,20 (Figure 1). TAVI end points and adverse events were considered according to the Valve Academic Research Consortium (VARC)-2 definitions.21 Paravalvular leak (PVL) was also assessed in line with VARC-2 criteria with transthoracic echocardiography examinations done at discharge reviewed retrospectively.20 Continuous variables were tested for a normality of distribution using the Shapiro-Wilk test and were reported and analyzed appropriately thereafter. Categorical variables were compared by chi-square statistics and by Fisher’s exact test. The Mann-Whitney U test was used in case of abnormal distribution. Cumulative survival rate was estimated by the Kaplan-Meier method, and differences were assessed with the log-rank test. For the Cox hazard model, univariate analysis of each of the possible predictors of 2-year all-cause mortality was performed, and only those variables that were significant with a p value of <0.05 were included in a stepwise Cox multivariable model. All statistical tests were 2-sided, and p values of <0.05 were considered significant. SPSS Statistics software 22.0 (SPSS, Chicago, Illinois) was used to perform all statistical analyses. Results Overall, 430 patients had mild or less LVOT calcium (147 of these specifically had mild LVOT calcium) and 107 had ≥moderate LVOT calcium. Baseline patient characteristics are listed in Supplementary Table S1. Although the none-mild LVOT-CA group had less female patients and a lower female : male ratio, gender difference did not affect the 2-year survival rate by stratified analysis (women 80.8% vs men 78.1%, p = 0.46). A history of a previous pacemaker implantation was found more in the ≤mild LVOT calcium group. Patients with ≥moderate LVOT calcium had a higher aortic valve mean gradient, a larger annulus size, and a greater aortic valve calcium volume (Table 1). Details on the procedural outcomes are listed in Table 2. At discharge, in the ≥moderate LVOT calcium group, 19 patients (17.8%) had ≥moderate PVL versus 24 patients (5.6%) in the ≤mild LVOT calcium group (p <0.001). ≥Moderate PVL rates for each valve type were S3 1.8%, CoreValve 19.4%, and Edwards-SAPIEN/SAPIEN XT 9.2%. For old generation valves, patients with ≥moderate LVOT calcium had higher ≥moderate PVL rates compared with those with ≤mild LVOT calcium (23.9% vs 8.0%, p <0.001). Conversely, there was no difference in ≥moderate PVL rates between the 2 groups in patients who underwent S3-TAVI with or without ≥moderate LVOT calcium (2.6% vs 1.5%, p = 0.53). Patients with higher grades of LVOT calcium had more instances of aortic annulus injury, required a pacemaker, and had acute kidney injury ≥stage 2 (Table 2). As a result, the ≥moderate LVOT

Figure 1. Grading of LVOT calcium severity by MDCT. The severity of LVOT calcium was assessed as mild: 1 nodule of calcium extending <5 mm and covering <10% of the perimeter of the annulus (A), moderate: 2 nodules or 1 extending >5 mm or covering >10% of the perimeter of the annulus (B), and severe: multiple nodules or a single focus extending >1 cm in length or covering >20% of the perimeter of the annulus (C). LC = left coronary; NC = non-coronary.

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Table 1 Baseline patients characteristics Variable

Age (years) (IQR) Women Body mass index (kg/m2) (IQR) Hypertension* Dyslipidemia* Diabetes mellitus* Chronic pulmonary obstructive disease* Coronary artery disease* Cerebrovascular disease* Peripheral artery disease* Previous CABG Previous myocardial infarction Previous pacemaker Chronic atrial fibrillation* Pulmonary hypertension* estimated GFR (ml/min) (IQR) STS score (%) EuroSCORE (IQR) Logistic Euro score, (%) (IQR) AV area (cm2) (IQR) Ejection fraction (%) (IQR) AV mean gradient (mmHg) (IQR) CT annulus mean diameter (mm) (IQR) CT annulus perimeter (mm) (IQR) CT annulus area (mm2) (IQR) AV calcium volume (HU-850) (mm3) (IQR)

LVOT calcium

p - value

≥moderate (n = 107)

None/mild (n = 430)

85 (78.0 – 88.0) 31 (29.0%) 25.9 (23.1 – 29.7) 229 (90.9%) 86 (80.7%) 28 (26.2%) 37 (34.6%) 64 (59.8%) 30 (28.0%) 39 (36.4%) 26 (24.3%) 20 (18.7%) 17 (15.9%) 16 (15.0%) 16 (15.0%) 46.9 (34.7 – 59.0) 8.1 ± 5.4 8.0 (6.0 – 10.0) 18.0 (10.7 – 27.9) 0.60 (0.50 – 0.70) 62.0 (52.0 – 68.0) 47.0 (40.0 – 57.0) 25.2 (23.5 – 27.0) 79.3 (74.4 – 85.0) 481.2 (422.3 – 558.7) 283.7 (159.7 – 556.8)

83 (78.0 – 88.0) 182 (42.3%) 25.8 (23.1 – 29.5) 266 (93.3%) 369 (85.8%) 148 (34.4%) 111 (25.8%) 268 (62.3%) 109 (25.3%) 162 (37.7%) 112 (26.0%) 60 (14.0%) 107 (24.9%) 58 (13.5%) 40 (9.3%) 45.0 (35.3 – 55.9) 7.9 ± 5.0 8.0 (6.0 – 10.0) 17.0 (10.6 – 30.3) 0.60 (0.50 – 0.70) 60.0 (49.0 – 67.0) 44.0 (40.0 – 50.0) 24.4 (22.4 – 26.1) 77.3 (71.6 – 82.5) 452.9 (391.8 – 522.5) 128.4 (60.2 – 245.5)

0.75 0.001 0.88 0.30 0.16 0.10 0.07 0.63 0.57 0.82 0.71 0.22 0.05 0.69 0.09 0.85 0.82 0.95 0.89 0.09 0.25 0.006 0.003 0.007 0.006 <0.001

Values are median (IQR), SD, or n (%). * Past history is defined as follows: undergoing treatment for, or diagnosed with a disease prior to transcatheter aortic valve implantation. Hypertension is defined in accordance with 2016 ACC/AHA guidelines. Dyslipidemia is defined in accordance with 2013 ACC/AHA blood cholesterol guidelines. AV = aortic valve; CABG = coronary artery bypass graft; IQR = interquartile range; LVOT = left ventricular outflow tract.

calcium group had a trend toward lower early safety at 30 days compared with the ≤mild LVOT calcium group (Table 2). At a median follow-up of 717 (interquartile range 484 to 828) days, a total of 113 patients had expired. Of these patients, 34 were in the group with ≥moderate LVOT calcium, whereas 65 patients were in the ≤mild LVOT calcium group. At the 2-year follow-up, the overall survival probability was significantly lower in ≥moderate LVOT calcium (81.6% vs 68.2%, log-rank p = 0.001) (Figure 2). The Cox regression analysis for cumulative 2-year all-cause mortality is listed in Table 3. Moderate-to-severe LVOT calcium was independently associated with causing an increased risk of 2-year mortality in the multivariate model (hazard ratio 1.74, 95% confidence interval 1.15 to 2.64, p = 0.009). Other significant predictors of all-cause mortality in this model included logistic EuroSCORE, eGFR, chronic atrial fibrillation, S3 valve implantation, and moderate-severe PVL at discharge (Table 3). For patients who underwent S3-TAVI, there was no difference in 2-year survival probability between patients who had ≥moderate LVOT calcium and patients with none-tomild LVOT calcium (none-mild 87.2% vs ≥moderate 78.9%, p = 0.18) (Figure 3). Conversely, if ≥moderate LVOT calcium was present, patients with older generation valves had a lower 2-year survival probability (79.1% vs 62.3%, p = 0.001) (Figure 3).

Discussion The present study is the first to assess the influence of LVOT calcium on midterm survival rate after TAVI. We demonstrated that moderate-to-severe LVOT calcium is associated with a decreased 2-year survival rate. Although patients with ≥moderate LVOT calcium had a trend toward lower early safety compared with those with none-to-mild LVOT calcium, both groups had similar rates of 30-day all-cause mortality. After reviewing 30-day follow-up notes, we conclude that moderate-to-severe LVOT calcium affects mortality after TAVI. Barbanti et al demonstrated that a high severity of LVOT calcium predicted annulus injury after balloon-expandable TAVI.17 Our findings are consistent with those of Barbanti et al.17 In the present study, all patients with annulus injury were doing well at the 30-day follow-up visit. This may be due to the lack of difference in early mortality between the 2 groups, although a high grade of LVOT calcium is strongly associated with adverse early and late postprocedural outcomes after TAVI.14–17 For acute kidney injury, the higher rates of acute kidney injury in the >moderate LVOT calcium group can potentially be explained by their higher early major complication rates, which may have resulted in decreased renal perfusion in the setting of vascular or bleeding complications. A possible explanation for why ≥moderate LVOT calcium was associated with a worse prognosis after TAVI may be

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Table 2 Procedural characteristics and 30-day outcome Variable

LVOT calcium ≥moderate (n = 107)

Valve type Edwards-SAPIEN/SAPIEN XT SAPIEN 3 CoreValve Valve size (mm) 23 26 29 31 Alternative access Pre-balloon dilatation Post-balloon dilatation Transthoracic echocardiography at discharge PVL none/trivial mild moderate/severe AV mean gradient (mmHg) (IQR) All-cause mortality Stroke/transit ischemia attack Myocardial infarction PCI during TAVI Early safety at 30-day* New permanent pacemaker implantation† New left bundle branch block Need for 2nd valve Valve embolism Aortic annulus injury Acute kidney injury stage 2 or 3 Any bleedings Life-threatening bleeding Major bleedings Major vascular complications

p-value None / mild (n = 430) 0.64

57 (53.3%) 38 (35.5%) 12 (11.2%)

247 (57.4%) 133 (30.9%) 50 (11.6%)

19 (17.8%) 46 (43.0%) 38 (35.5%) 4 (3.7%) 13 (12.1%) 74 (69.2%) 22 (20.6%)

113 (26.3%) 189 (44.0%) 112 (26.0%) 16 (3.7%) 59 (13.7%) 227 (52.9%) 41 (9.5%)

0.034

50 (46.7%) 38 (35.5%) 19 (17.8%) 10.0 (8.0 – 13.5) 3 (2.8%) 3 (2.8%) 2 (0.5%) 2 (1.9%) 91 (85.0%) 21 (23.3%) 11 (13.4%) 3 (2.8%) 0 4 (3.7%) 7 (6.5%) 12 (11.2%) 2 (1.9%) 7 (6.5%) 4 (3.7%)

0.67 0.002 0.002

288 (67.0%) 118 (27.4%) 24 (5.6%) 9.0 (7.0 – 12.0) 11 (2.6%) 8 (1.9%) 0 9 (2.1%) 391 (90.9%) 38 (11.8%) 38 (12.8%) 6 (1.4%) 1 (0.2%) 1 (0.2%) 10 (2.3%) 30 (7.0%) 8 (1.9%) 18 (4.2%) 11 (2.6%)

<0.001 0.10 <0.001 0.13 0.55 0.38 0.64 0.62 0.072 0.006 0.88 0.26 0.80 0.006 0.035 0.14 0.62 0.21 0.35

Values are median (IQR), or n (%). * Absence of all-cause mortality, stroke, life-threatening bleeding, major vascular complications, acute kidney injury ≥ stage 2, repeat procedure, and coronary artery obstruction. † Patients with previous pacemaker implants were excluded. AV = aortic valve; IQR = interquartile range; LVOT = left ventricular outflow tract; PCI = percutaneous coronary intervention; PVL = paravalvular leak; TAVI = transcatheter aortic valve implantation. Table 3 Multivariate Cox proportional hazard analysis of all-causes mortality at 2 years Univariate analysis

Logistic EURO score eGFR Chronic atrial fibrillation Moderate/severe LVOT calcium SAPIEN 3 ≥ moderate PVL at discharge Age Pulmonary hypertension Chronic obstructive pulmonary disease Previous myocardial infarction Ejection Fraction Alternative access Peripheral artery disease

Multivariate analysis

Hazard ratio (95% CI)

p - Value

1.03 (1.02 – 1.04) 0.97 (0.96 – 0.98) 2.20 (1.44 – 3.37) 1.93 (1.29 – 2.88) 0.53 (0.34 – 0.82) 3.49 (2.15 – 5.67) 1.03 (1.01 – 1.06) 2.58 (1.62 – 4.11) 1.51 (1.03 – 2.22) 1.70 (1.09 – 2.65) 0.99 (0.97 – 0.99) 2.02 (1.28 – 3.16) 1.58 (1.09 – 2.28)

<0.001 <0.001 <0.001 0.001 0.005 <0.001 0.020 <0.001 0.036 0.020 0.015 0.002 0.015

Parameters for prediction (p < 0.05) were entered into a Cox proportional hazard model. CI = confidence interval; LVOT = left ventricular outflow tract; PVL = paravalvular leak.

Hazard ratio (95% CI) 1.02 (1.01 – 1.03) 0.98 (0.97 – 0.99) 2.26 (1.47 – 3.48) 1.74 (1.15 – 2.64) 0.59 (0.37 – 0.93) 2.93 (1.75 – 4.92) Dropped Dropped Dropped Dropped Dropped Dropped Dropped

p - Value <0.001 <0.001 <0.001 0.009 0.022 <0.001

Valvular Heart Disease/TAVI in Patients With LVOT Calcium

2021

Figure 2. Overall survival probability during the 2-year follow-up period. Overall survival probability during the study follow-up period. Differences in survival probability in patients after transcatheter aortic valve implantation, shown according to the severity of LVOT calcium: none-mild and moderate-severe. CI = confidence interval; HR = hazard ratio.

related to PVL. Recent studies further showed that LVOT calcium is a stronger predictor of PVL after TAVI compared with leaflet calcification. 14,15,18 Nonetheless, the interaction between LVOT calcium, PVL, and midterm outcome was less certain. Kodali et al reported that ≥moderate PVL after TAVI resulted in increased 1-year mortality.4 Furthermore, an increased LVOT calcium volume was significantly associated with the severity of PVL.16 Therefore, the potential mechanism explaining the results of the present study is that increased PVL in patients with ≥moderate LVOT calcium is facilitating the increase in midterm mortality. Nevertheless, other factors such as conduction abnormalities, which LVOT calcium predicted, may contribute to our findings.22 Of those patients with ≥moderate LVOT calcium who did not require pacemaker implantation during index hospitalization, some developed a high degree of atrioventricular block after discharge. All of these factors can potentially contribute to mortality. In the subanalysis, for patients who underwent S3-TAVI, there was no difference in midterm mortality between the ≥moderate LVOT calcium and the none-to-mild LVOT calcium groups, in contrast with those with older generation valves. Several parameters could account for these findings. S3 valves consist of a cobalt-chromium frame with a large cell design, which contributes to its high radial strength.23 Thus, for cases with severe calcification, S3 valve expansion can be greater than older generation valves.23 S3 valves also have important features that appear to mitigate PVL, including an external

cuff that increases its profile at the inflow.20 Moreover, old generation self-expanding valves resulted in lower device success than balloon-expandable valves.24 In addition, some cardiac parameters did improve after the procedure, such as cardiac function and mitral valve regurgitation. Particularly, S3-TAVI for ≥moderate LVOT calcium might affect longterm cardiac hemodynamics more than old generation valves.25–28 These may also be a possible reason that S3TAVI done in the setting of ≥moderate LVOT calcium had relatively similar rates of survival as those of none-to-mild LVOT calcium. Noticeably, the present study showed that patients with ≥moderate LVOT calcium who underwent S3TAVI had a trend of lower survival rate after 1 year. Longerterm monitoring is necessary to confirm this observation. To summarize, patients with moderate-to-severe LVOT calcium were shown to have lower survival rates at 2 years. Patients with high-grade LVOT calcium should be monitored with longer-term follow-ups after TAVI. Several limitations of the present study should be addressed. The study represents a retrospective, single-center experience. The findings are subject to selection bias. Valvetype selection was left to the operator’s discretion. Future multicenter studies may further clarify this subject. Disclosures Dr. Jilaihawi is a consultant for Edwards Lifesciences Corporation, St. Jude Medical, and Venus MedTech. Dr. Makkar

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Figure 3. (A, B) Comparison of overall survival probability in patients with different valve designs according to the severity of LVOT calcium. For SAPIEN 3 valves, no differences were found in the survival probability between moderate-to-severe LVOT calcium and none-to-mild LVOT calcium (A). Conversely, if moderate or severe LVOT calcium was present, old generation valves had a lower survival probability at 2 years. CI = confidence interval; CV = CoreValve; HR = hazard ratio; XT = SAPIEN XT.

has received grant support from Edwards Lifesciences Corporation and St. Jude Medical; is a consultant for Abbott Vascular, Cordis, and Medtronic; and holds equity in Entourage Medical.

Supplementary Data Supplementary data associated with this article can be found, in the online version, at https://doi.org/10.1016/ j.amjcard.2017.08.018.

Valvular Heart Disease/TAVI in Patients With LVOT Calcium 1. Makkar RR, Fontana GP, Jilaihawi H, Kapadia S, Pichard AD, Douglas PS, Thourani VH, Babaliaros VC, Webb JG, Herrmann HC, Bavaria JE, Kodali S, Brown DL, Bowers B, Dewey TM, Svensson LG, Tuzcu M, Moses JW, Williams MR, Siegel RJ, Akin JJ, Anderson WN, Pocock S, Smith CR, Leon MB, PARTNER Trial Investigators. Transcatheter aortic-valve replacement for inoperable severe aortic stenosis. N Engl J Med 2012;366:1696–1704. 2. 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. 3. Adams DH, Popma JJ, Reardon MJ, Yakubov SJ, Coselli JS, Deeb GM, Gleason TG, Buchbinder M, Hermiller J Jr, Kleiman NS, Chetcuti S, Heiser J, Merhi W, Zorn G, Tadros P, Robinson N, Petrossian G, Hughes GC, Harrison JK, Conte J, Maini B, Mumtaz M, Chenoweth S, Oh JK, U.S. CoreValve Clinical Investigators. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med 2014;370:1790–1798. 4. Kodali S, Pibarot P, Douglas PS, Williams M, Xu K, Thourani V, Rihal CS, Zajarias A, Doshi D, Davidson M, Tuzcu EM, Stewart W, Weissman NJ, Svensson L, Greason K, Maniar H, Mack M, Anwaruddin S, Leon MB, Hahn RT. 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 2015;36:449– 456. 5. Yamamoto M, Hayashida K, Mouillet G, Hovasse T, Chevalier B, Oguri A, Watanabe Y, Dubois-Randé JL, Morice MC, Lefèvre T, Teiger E. Prognostic value of chronic kidney disease after transcatheter aortic valve implantation. J Am Coll Cardiol 2013;62:869–877. 6. Rodés-Cabau J, Webb JG, Cheung A, Ye J, Dumont E, Osten M, Feindel CM, Natarajan MK, Velianou JL, Martucci G, DeVarennes B, Chisholm R, Peterson M, Thompson CR, Wood D, Toggweiler S, Gurvitch R, Lichtenstein SV, Doyle D, DeLarochellière R, Teoh K, Chu V, Bainey K, Lachapelle K, Cheema A, Latter D, Dumesnil JG, Pibarot P, Horlick E. Long-term outcomes after transcatheter aortic valve implantation: insights on prognostic factors and valve durability from the Canadian multicenter experience. J Am Coll Cardiol 2012;60:1864– 1875. 7. Ludman PF, Moat N, de Belder MA, Blackman DJ, Duncan A, Banya W, MacCarthy PA, Cunningham D, Wendler O, Marlee D, HildickSmith D, Young CP, Kovac J, Uren NG, Spyt T, Trivedi U, Howell J, Gray H, UK TAVI Steering Committee and the National Institute for Cardiovascular Outcomes Research. Transcatheter aortic valve implantation in the United Kingdom: temporal trends, predictors of outcome, and 6-year follow-up: a report from the UK transcatheter aortic valve implantation (TAVI) Registry, 2007 to 2012. Circulation 2015;131:1181– 9110. 8. 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 SJ, Baumbach A, Daniel T, Gray H, Mullen MJ. Long-term outcomes after transcatheter aortic valve implantation in high-risk patients with severe aortic stenosis: the U.K. TAVI (United Kingdom Transcatheter Aortic Valve Implantation) registry. J Am Coll Cardiol 2011;58:2130– 2138. 9. Herrmann HC, Thourani VH, Kodali SK, Makkar RR, Szeto WY, Anwaruddin S, Desai N, Lim S, Malaisrie SC, Kereiakes DJ, Ramee S, Greason KL, Kapadia S, Babaliaros V, Hahn RT, Pibarot P, Weissman NJ, Leipsic J, Whisenant BK, Webb JG, Mack MJ, Leon MB, PARTNER Investigators. One-year clinical outcomes with SAPIEN 3 transcatheter aortic valve replacement in high-risk and inoperable patients with severe aortic stenosis. Circulation 2016;134:130–140. 10. Beohar N, Zajarias A, Thourani VH, Herrmann HC, Mack M, Kapadia S, Green P, Arnold SV, Cohen DJ, Généreux P, Xu K, Leon MB, Kirtane AJ. Analysis of early out-of hospital mortality after transcatheter aortic valve implantation among patients with aortic stenosis successfully discharged from the hospital and alive at 30 days (from the placement of aortic transcatheter valves trial). Am J Cardiol 2014;114:1550– 1555. 11. Chopard R, Teiger E, Meneveau N, Chocron S, Gilard M, Laskar M, Eltchaninoff H, Iung B, Leprince P, Chevreul K, Prat A, Lievre M,

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