MSCT guided sizing of the Edwards Sapien XT TAVI device: Impact of different degrees of oversizing on clinical outcome

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Page 1 of 1 IJCA-15953; No of Pages 7 International Journal of Cardiology xxx (2013) xxx–xxx Contents lists available at SciVerse ScienceDirect International Journal of Cardiology journal homepage: www.elsevier.com/locate/ijcard 2 Q1 3 4 5 6 7 8 9 MSCT guided sizing of the Edwards Sapien XT TAVI device: Impact of different degrees of oversizing on clinical outcome R O O F 1 A.W. Leber a, b,⁎, W. Eichinger c, J. Rieber b, M. Lieber c, S. Schleger c, U. Ebersberger b, M. Deichstetter b, J. Vogel b, T. Helmberger d, D. Antoni b, G. Riess b, E. Hoffmann b, A.M. Kasel b, e a Schulich Heart Center at Sunnybrook Health Science Center Toronto, Univ. of Toronto, Canada Heart Center Munich Bogenhausen at Klinikum München Bogenhausen, Dept. of Cardiology, Munich, Germany Heart Center Munich Bogenhausen at Klinikum München Bogenhausen, Dept. of Cardiac Surgery, Munich, Germany d Klinikum München Bogenhausen, Dept. of Radiology, Munich, Germany e German Heart Centre Munich, Dept. of Cardiology, Technical University of Munich, Munich, Germany b c a r t i c l e i n f o a b s t r a c t Aims: Prospective data on the usage of 3-dimensional imaging based annulus sizing on the outcome of TAVI is not available yet and there is general uncertainty about the optimal degree of oversizing. In the current study we therefore assessed a 3-D MSCT guided over-sizing approach and evaluated the clinical outcome of different degrees of oversizing. Methods: TAVI-size-selection was done using systolic MSCT-annulus cross-sectional-area (CSA) measurements in 107 patients with severe aortic stenosis with the goal to oversize the 3rd generation balloon expandable Edwards Sapien XT (ESTV) device in relation to the native aortic annulus CSA. Results: Among different degrees of oversizing there were no differences in the occurrence of stroke, myocardial infarction and death. No aortic injuries were observed. The overall rate of >mild postprocedural aortic regurgitation (PAR) was 7.6%. Increasing oversizing ratios are associated with lower rates of >mild PAR (r = −0.236, p b 0.02) with the lowest rate of >mild PAR in patients with area based oversizing ratios >25% and the highest rate in patients with oversizing ratios b 15% (0% vs. 15.8%, p b 0.02). The rate of postprocedural permanent pacemakers tended to be lower in patients with b15% oversizing compared to those with >25% oversizing (5.3 vs. 16.7%, p b 0.23). Conclusions: MSCT guided ESTV-device sizing is safe and is associated with significantly lower than previously reported rates for PAR. A device/annulus oversizing ratio of 15–25% based on area and 7–12% based on mean diameter appears to provide the best risk-benefit ratio in terms of PAR reduction and conduction disorders. © 2013 Published by Elsevier Ireland Ltd E D Article history: Received 20 July 2012 Received in revised form 11 February 2013 Accepted 17 March 2013 Available online xxxx C T Keywords: TAVI Aortic stenosis MSCT Transcatheter valve therapy R R E 11 12 13 14 15 16 17 18 19 20 21 22 23 24 P 10 46 C 1. Introduction 48 49 There is an increasing number of patients with severe aortic stenosis, who are not considered surgical candidates because of significant co morbidities. In these patients trans catheter aortic valve implantation (TAVI) emerged during the past years with excellent clinical results [1–5]. Significant or mild post procedural aortic regurgitation (AR) is a frequent problem associated with TAVI occurring in up to 50% of U 52 53 N 47 50 51 43 44 O 45 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 Abbreviations: TAVI, transcatheter aortic valve implantation; AR, aortic regurgitation; PAR, postprocedural aortic regurgitation; PM, pacemaker; CSA, cross sectional area; TEE, transesophageal echocardiography; ESTV, Edwards Sapien Transcatheter Heart Valve; MSCT, multi slice CT. ⁎ Corresponding author at: Institute for Cardiac Imaging and Intervention, Schulich Heart Centre, Sunnybrook Health Science Centre, University of Toronto, Canada, 2075 Bayview Ave, M4N3M5 Toronto, Ontario, Canada. E-mail address: Dr_leber@gmx.de (A.W. Leber). patients [6–9]. In the recent report of the 2-year results of the pivotal PARTNER trial a linear relationship between the severity of post procedural AR and 1-and 2-year mortality was seen, with even mild AR being associated with increased mortality [1]. Hence strategies to avoid post procedural AR are currently the major targets to further improve long term survival. Severe valve calcifications, under sizing of the device in relation to the annulus and too deep or too high implantation levels are predisposing factors for paravalvular AR [6,10,11]. Device sizing is currently based on manufacturer recommendations that are dervied from echocardiography data, although these methods do not take into account the elliptic anatomy of the aortic annulus [12,13] and are prone to erroneous off axis measurements resulting in significant over-and underestimations of the true annulus size. No prospective data is currently available on the potential impact of using more precise 3-dimensional imaging data for device sizing on clinical outcome of TAVI with the Edwards Sapien trans catheter valve (ESTV). In particular the effects of different degrees of oversizing are 0167-5273/$ – see front matter © 2013 Published by Elsevier Ireland Ltd http://dx.doi.org/10.1016/j.ijcard.2013.03.030 Please cite this article as: Leber AW, et al, MSCT guided sizing of the Edwards Sapien XT TAVI device: Impact of different degrees of oversizing on clinical outcome, Int J Cardiol (2013), http://dx.doi.org/10.1016/j.ijcard.2013.03.030 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 2 A.W. Leber et al. / International Journal of Cardiology xxx (2013) xxx–xxx 2. Methods 82 2.1. Patients The population consisted of 107 consecutive patients with severe and symptomatic aortic stenosis, in whom pre procedural MSCT could be performed and who underwent TAVI using the balloon expandable ESTV in the time period between June 2010 and February 2012. Our center (Klinikum Munich Bogenhausen) has experience with TAVI since late 2007 using the CoreValve. The Edwards Sapien program was initiated in 2009. At an interdisciplinary conference consisting of cardiologists and cardiac surgeons all included patients were refused for surgical valve replacement and were jointly selected as TAVI candidates. The decision to perform TAVI was based on the recommendations from the European Association of Cardio-Thoracic Surgery (EACTS) and the European Society of Cardiology (ESC) [14]. Patient characteristics are given in Table 2. All patients undergoing TAVI were prospectively enrolled after they gave written informed consent for the TAVI procedure, related imaging, scheduled follow-up and anonymous data collection storage for scientific purposes in the form of a registry. The protocol was approved by the responsible review board. In addition to consenting the patient, a comprehensive consult with the family, including description of the sizing strategy, procedural planning and risks and outcomes of the procedure was done by the operator. The authors of this manuscript have certified that they comply with the Principles of Ethical Publishing in the International Journal of Cardiology. 2.2. TAVI procedure 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 The 3rd generation Edwards Sapien XT balloon expandable TAVI device is available in three different sizes (23, 26 and 29 mm). According to the manufacturer recommendations oversizing is advocated and size selection should be based on TEE measurements. For annulus diameters ranging from 18 to 21 mm the 23 mm, from 22 to 24 the 26 mm and from 25 to 28 the 29 mm device is recommended with a gray zone in between the different sizes. In our patient cohort we used the systolic cross sectional area of the aortic annulus at the level of the basal ring, which was determined by MSCT as the reference for device sizing (Fig. 1). Given the nominal CSA of the different devices (4152 mm for the 23 mm, 5312 mm for the 26 mm and 6612 mm for the 29 mm ESTV) we aimed for the next available device size exceeding or nearly equaling the CSA of the native annulus. Patients with annuli b290 mm2 and those with annuli >650 mm2 were excluded. The 23 mm device was selected for patients with annulus CSA from 290 to 415 mm2, the 26 mm device for annulus sizes of 416–530 mm2 and the 29 mm device for annulus sizes ranging from 531 to 650 mm2. For patients with annuli in the borderline zone (400–430 mm2, 510–530 mm2), where the choice is to either undersize or aggressively oversize, size selection was based on the presence of annular and sub valvular calcium. Furthermore in most of these patients an angiogram during balloon valvuloplasty was done. In the presence of any sub valvular and annular calcification and no obvious AR during balloon valvuloplasty the smaller device was chosen in order to minimize the risk for annulus ruptures. In those patients without calcium and AR during balloon valvuloplasty more aggressive oversizing was performed (see Table 1 and Fig. 3). As a 29 mm device was not available for transfemoral delivery during the inclusion period, patients with an annulus >530 mm2 b 650 mm2 were treated via the transapical approach. The same approach was selected in patients with either too small (b6 mm diameter) or heavily diseased or kinked femoral and iliac vessels. For the transfemoral approach an 18 F sheath was introduced into the left or right femoral artery. Another arterial (5fF) and a venous sheath (6 F) were placed in the contralateral t1:1 t1:2 Table 1 Strategy for device sizing based on MSCT measurements and aortogram during BAV. C E R R O C U N Valve size 23mm Annulus area (mm2) 26mm 29mm 290−400 400−430 400−430 430−510 510−530 510−530 19−22.5 22.5−23.5 22.5−23.5 23.5−25.5 25.5−26.0 25.5−26.0 26.0−28.5 Subvalvular calcification + - + - Aortogramm during BAV with evidence of sig. AR - + - + Annulus mean diameter (mm) 530−650 t2:20 t2:21 and the transapical valves) or 23 mm balloon (for the 26 mm valve) was done under rapid pacing. For implantation the Novaflex ® delivery system was used for transfemoral delivery. The valve was implanted under fluoroscopic guidance also during rapid ventricular pacing. After implantation an aortogram from the RAO-projection (40 ml @ 15 ml/s) was done to determine the grade of aortic regurgitation. We also graded the implantation level of the device as normal, too high or too low. For the transapical approach a mini-thoracotomy was done. The left ventricular apex was punctured and the aortic valve was passed with a wire that was placed in the descending aorta. Over this wire the Ascendra® delivery system (Edwards Lifesciences, California, USA) was introduced and the ESTV was delivered in the same fashion as described above. 2.3. Pre procedural multi slice CT T 100 Numbers/percentages in parenthesis. Mean ± SD. R O 83 84 85 86 87 88 89 90 91 Q2 92 93 94 95 96 97 98 99 P 78 79 4 (3.7) 83 (77.6) 20 (18.7) 55 (51.4) 9 (8.4) 26 (24.3) 12(11.2) 53.72 ± 9.12 1.13 ± 0.43 835.1 ± 1178.57 7 (6.5) 10.94 ± 8.9 23.67 ± 14.19 t2:3 t2:4 t2:5 t2:6 t2:7 t2:8 t2:9 t2:10 t2:11 t2:12 t2:13 t2:14 t2:15 t2:16 t2:17 t2:18 t2:19 D 77 81.5 ± 5.70 30 (28,0) 77 (72.0) E 75 76 Age Male Female NYHA classification II III IV CAD Previous MI Previous PCI Previous cardiac surgery EF in % Creatinine mg/ml BNP pre procedural Previous stroke STS-score Log Euro-score F 81 73 74 femoral artery Table 2 and a pig-tail catheter and a temporary pacemaker lead were introduced. t2:1 128 BeforeClinical valve implantation a single balloon valvuloplasty with a 20 mm (for the 23 t2:2 mm 129 characteristics. O 80 not well understood, although this may have significant clinical importance for sizing strategies in the future. In the current study we therefore used pre procedural contrast enhanced, gated multislice CT (MSCT) to guide the sizing of the 3rd generation Edwards Sapien XT device and we evaluated the functional and clinical effects of this approach. The goals of our analyses were: 1. To assess the short term functional and clinical result of a MSCT derived (over)-sizing approach in dependence of the degree of oversizing and 2. to assess potential differences concerning device-size selection between measurements of the annulus obtained by MSCT and TEE. 71 72 130 131 132 133 134 135 136 137 138 139 140 In all patients we performed MSCT coronary angiography (Philips Brilliance 64, Philips Medical, Eindhoven, Netherlands) 7–18 days before the procedure. The scan was done using retrospective ecg-gating in spiral technique (120 KV, 600 mA s) allowing reconstruction of images during systole and diastole. 80 cm3 of contrast agent was administered through an intravenous line at a flow rate of 4 cm3/s. For optimal contrasting a bolus tracking technique was applied. Patients with impaired kidney function with a GFR b 30 ml/min were adequately treated using saline infusions before and after the scan, further a modified scan protocol covering only the heart was utilized. Two experienced investigators assessed the following parameters from systolic datasets: minimum and maximum diameter, mean diameter and cross-sectional area of the aortic annulus. To standardize these measurements and to correct for partial volume effects on the annulus borders we used the full width half maximum method. In the case of severe calcifications the most probable course of the annulus border was anticipated based on geometric assumptions. All measurements were done using a commercially available post processing software (Philips Medical, Eindhoven, The Netherlands). 141 142 143 144 145 146 147 148 149 150 151 152 153 154 155 156 2.4. Pre and post-procedural echocardiography 157 In all patients pre procedural TTE and TEE were done using a Philips I33 ultrasound system (Philips medical, Eindhoven, The Netherlands), for the purposes of determining the annulus diameter as well as to assess general parameters like pressure gradients, mitral valve, tricuspid valve and left ventricular function. TEE measurements of annulus diameters were done on a zoomed long-axis mid systolic frame by a hinge point to hinge point measurement (Fig. 2). Post-TAVI bioprosthetic function was assessed in line with guidelines suggested by the Valve Academic Research Consortium using TTE in all patients within 4 h after the procedure [15]. For the assessment of prosthesis regurgitation TTE examinations were reviewed retrospectively by a physician reader with extensive experience in the assessment of TAVR echocardiograms and who was blinded to clinical and procedural parameters. AR was graded as no, trivial, mild, mild-, moderate and moderate–severe. 158 159 160 161 162 163 Q3 164 165 166 167 168 169 2.5. Grading of aortic regurgitation 170 Two independent and blinded readers did grading of AR. In the case of non-consensus 171 between both modalities the most severe finding of any of the two modalities was used 172 for further analysis. 173 2.6. Data collection 174 !Data regarding clinical status, pre procedural TEE, MSCT and procedural features were collected and included to a database. Clinical and instrumental (TTE) follow-up were obtained by routine clinical visit at our Institution 30 days after TAVI. In case of an adverse event at another center, medical records or discharge letters from the 175 176 177 178 Please cite this article as: Leber AW, et al, MSCT guided sizing of the Edwards Sapien XT TAVI device: Impact of different degrees of oversizing on clinical outcome, Int J Cardiol (2013), http://dx.doi.org/10.1016/j.ijcard.2013.03.030 3 A.W. Leber et al. / International Journal of Cardiology xxx (2013) xxx–xxx oblique coronal Double oblique axial Plane oblique sagital R O O F LA IVS Diameter: 27.2 x 21.6 mm Area: 450mm2 C T E D P Fig. 1. Method to obtain the axial plane of the aortic annulus by MSCT from oblique sagittal and oblique coronal views. O R R E TEE maximum diameter C LA minimal diameter diameter 21.5mm U N CT double oblique 23mm Valve IVS Mean diameter 24.2 mm Area 450mm 26mm Valve Fig. 2. Clinical example of 2-dimensional TEE derived measurements compared to 3-dimensional MSCT measurements. The red dotted arrows indicate the typical off axis orientations of TEE measurements. (For interpretation of the references to color in this figure legend, the reader is referred to the web version of this article.) Please cite this article as: Leber AW, et al, MSCT guided sizing of the Edwards Sapien XT TAVI device: Impact of different degrees of oversizing on clinical outcome, Int J Cardiol (2013), http://dx.doi.org/10.1016/j.ijcard.2013.03.030 4 A.W. Leber et al. / International Journal of Cardiology xxx (2013) xxx–xxx A Annulus Size: 408mm Calcification present R O O F No AR with 20mm Balloon P 23mm Device with a nominal area of 415mm 1,7% oversizing E T Annulus size: 420mm No calcification U N C O R R E C Significant AR during BAV using a 20mm Balloon D B 26mm Device with a nominal area of 531mm 26% oversizing Fig. 3. Illustration of the sizing strategy in the case of annulus sizes in the gray zone. A) Demonstrates the scenario in which very minor or even undersizing may be accepted. The aortogram during balloon valvuloplasty using a 20 mm balloon does not reveal AR. MSCT of the annulus reveals significant calcified nodules, indicating potential risk for annulus rupture. B) Scenario where aggressive oversizing is accepted: significant AR during balloon valvuloplasty and no calcium on the level of the annulus. 179 Q4 180 other institutions were systematically reviewed. General practitioners and referring physicians were contacted for additional information, if necessary (Table 3). 181 2.7. Statistical methods 182 183 Continuous variables are described as mean and standard deviation. Categorical variables are described by frequencies and percentages. Continuous parametric variables were compared using unpaired and paired Student t test as appropriate. Continuous nonparametric variables were compared using the Mann–Whitney U test. Categorical variables were compared using Fisher exact test. Intraclass correlation coefficient was defined as the ratio of between-subject variance to the total. Proportions were compared using the two-sided Z-Test and the 2-sided Monte Carlo method. One-way analysis of variance was used to compare the difference in means from 3 groups with different degrees of device oversizing. Please cite this article as: Leber AW, et al, MSCT guided sizing of the Edwards Sapien XT TAVI device: Impact of different degrees of oversizing on clinical outcome, Int J Cardiol (2013), http://dx.doi.org/10.1016/j.ijcard.2013.03.030 184 185 186 187 188 189 190 A.W. Leber et al. / International Journal of Cardiology xxx (2013) xxx–xxx Transfemoral approach (n) Transapical approach (n) Valve size: 23 mm 26 mm 29 mm Annulus mean diameter MSCT (mm) Annulus mean diameter TEE (mm) Mean annulus CSA MSCT (mm2) Annulus ovality index 70 37 192 193 3.1. Procedural outcome, post-procedural aortic regurgitation and new pacemaker implantation 194 214 215 Intraprocedural mortality was 1.8% (2 of 107 patients); 30 day all cause mortality was 6.5% (7 of 107). The rate of major stroke within 30 days was 3.7% (4 of 107). In 53 of the 105 (50.4%) patients, who survived the procedure any post procedural AR was observed. AR was paravalvular in 49 and valvular in 4 cases. AR was graded trivial in 29 of 105 patients (27.6%), mild in 16 of 105 (15.2%), mild to moderate in 4 of 105 (3.8%), moderate in 3 of 105(2.9%) and moderate to severe in 1 of 105 (1%) patients. The rate for worse than mild AR was 7.6% (8 of 105). No severe AR was observed. The degree of oversizing (coefficient −0.236, 95% c.i.: −0.51 to −0.07, p b 0.018) was the only significant predictor of >mild PAR in multivariate regression analysis in a model that included annulus ovality index and annulus CSA. In one patient a second valve as bail out had to be implanted due to a too low position of the first valve with moderate AR after the second valve. One device embolization into the LV was observed due to a too low implantation level with subsequent conversion to open heart surgery. In the remaining patients valve position was considered adequate. The rate of pacemaker implantation after TAVI was (11of 107) 10.2%. The indications for permanent pacemaker implantation were intermittent or permanent higher degree AV-blocks (AV-Block II Type 2 or AV-Block III) that lasted longer than 4 days post procedure. Procedural outcome based on the degree of oversizing is summarized in Table 4. 216 3.2. Influence of MSCT vs. TEE measurements on size selection 217 218 219 In overall 39 patients TAVI device selection based on MSCT- and TEE-annulus measurements differed. In all except of three patients TEE measurements were in favor for a smaller sized valve (Table 5). 220 4. Discussion 221 222 223 224 This is the first study evaluating a systematic MSCT guided TAVI oversizing approach in terms of clinical and functional effect of the 3rd generation Edwards Sapien XT device in dependence of various degrees of oversizing. 225 4.1. Clinical impact of MSCT guided prosthesis sizing 226 By using an MSCT guided sizing approach with an average valve oversizing ratio of 19.4% (nominal ESTV CSA/annulus CSA) based on the native annulus CSA and 9.6% based on mean diameter we did not observe any annulus rupture or aortic dissection associated with the device implantation. Periprocedural mortality and stroke rates were similar to that of the PARTNER trial and other data from single and multicenter registries and did not differ in groups with different degrees of valve oversizing [4,5,16–18]. The most important finding in the current study is the relatively low incidence of post procedural aortic regurgitation. Although any AR was still present in more than 210 211 212 213 227 228 229 230 231 232 233 234 Q5 235 C 208 209 E 206 207 R 204 205 R 203 O 201 202 C 199 200 N 197 198 U 195 196 4.2. Effect of different degrees of over-sizing 246 To date there is an ongoing uncertainty on the optimal oversizing ratio in particular of balloon expandable devices, as there are concerns of fatal complications in the scenario of too rigorous oversizing. Although not observed in our series too rigorous oversizing is considered as a risk factor for annulus ruptures and aortic dissections in particular in the presence of subvalvular calcium and we therefore avoided aggressive oversizing in these patients. Our analysis of the effects of different degrees of oversizing revealed that aggressive oversizing >25% based on area measurements (>12% based on mean diameter) eliminates significant PAR but may induce conductance disorders requiring pacemaker implantations in a substantial number of patients. On the other hand less aggressive oversizing b 15% of annulus CSA (b 7% of mean diameter) is associated with a higher incidence of PAR. We found an oversizing ratio of 15–25% compared to the native annulus CSA and 7–12% based on the mean diameter to provide the best risk and benefit ratio. A major problem in clinical practice however is the fact that the desired oversizing ratio is determined by available device sizes and the given patient anatomy. In our cohort only one third of the patients fitted into the optimal oversizing range. This fact indicates the need for more available sizes or device designs that allow operator regulated size optimization. Another option is the possibility to underfill the balloon with 1–3 cm3 less than recommended by the manufacturer. This approach is currently investigated but there may be concerns with regards to device expansion and durability. However even with the availability of more sizes, size and device selection still hinges to some degree on the individual anatomy of the aortic root. Factors like the presence and extent of calcium, ovality of the annulus and tapering of the LVOT have to be taken into account on an individual basis. It is also important to incorporate multimodal information, in particular in borderline size ranges. Our approach to perform an aortogram simultaneously to the balloon valvuloplasty has been shown to be an effective additional tool. In conclusion TAVI sizing is of enormous importance and emphasizes the need for comprehensive assessment of the MSCT datasets, the need for specified training in TAVI image interpretation and reporting and the use of multimodal image information. P 3. Results T 191 236 237 R O O F 41 (38.3) 53 (49.5) 13 (12.1) 23.0 ± 1.8 21.7 ± 2.1 418.6 ± 65.0 1.125 ± 0.17 half of the patients, the rate of not only moderate and severe AR but also of mild AR was substantially lower than previously reported from echocardiography-guided studies with moderate and severe AR occurring in 10–30% of cases. In a recent study Jilaihawi et al. compared a conventional TEE-sizing approach in 96 patients to a MSCT based sizing approach in 40 patients treated with the Edwards Sapien prosthesis. They demonstrated that the rate of worse than mild PAR was significantly lower in the MSCT group than in the TEE guided group (7.5% vs. 21.9%) and reported of a similar PAR rate as noted in our cohort (AR rate worse than mild 7.6%) [12,23–29]. D t3:3 t3:4 t3:5 t3:6 t3:7 t3:8 t3:9 t3:10 t3:11 t3:12 Table 3 Procedural and pre procedural imaging characteristics. E t3:1 t3:2 5 238 239 240 241 242 243 244 245 247 248 249 250 251 252 253 254 255 256 257 258 259 260 261 262 263 264 265 266 267 268 269 270 271 272 273 274 275 276 277 278 279 280 281 4.3. Impact of TEE and MSCT derived measurements on device size 282 selection 283 We have demonstrated that TEE systematically underestimates the mean annulus diameter, so that the manufacturer echo-based size recommendations need to be challenged. Our selected valve size differed in 35% of patients from a TEE-based size selection. This is in line with previous reports that compared MSCT and echo measurements [12,20–22,28,29]. For clinical purposes MSCT has the advantage of excellent resolution and accuracy to measure dimensions of the aortic root, quantify calcification and to assess the potential access sites [26,27]. Those in combination of broad availability of MSCT and quick scan times currently predispose MSCT as the most comprehensive screening tool before TAVI. The needs of contrast agent and the exposure to radiation of course do limit its application in particular in patients with renal failure. Please cite this article as: Leber AW, et al, MSCT guided sizing of the Edwards Sapien XT TAVI device: Impact of different degrees of oversizing on clinical outcome, Int J Cardiol (2013), http://dx.doi.org/10.1016/j.ijcard.2013.03.030 284 285 286 287 288 289 290 291 292 293 294 295 6 t4:1 t4:2 A.W. Leber et al. / International Journal of Cardiology xxx (2013) xxx–xxx Table 4 Impact of prosthesis oversizing on clinical and functional outcome. t4:3 Device oversizing in relation to native annulus t4:4 Group I II III p-Values t4:5 Area based All b15% 15–25% >25% t4:6 n 107 39 37 31 t4:7 Δ ESTV CSA — annulus CSA (mm2) 80.1 ± 41.3 41.5 ± 12.6 89.0 ± 24.1 118.1 ± 34.3 t4:31 t4:34 t4:37 t4:40 t4:43 Mild–moderate AR 7 (18.4) 4 (3.8) Moderate AR 3 (7.9) 3 (2.9) Moderate–severe AR 25 (65.8) 4 (3.7) All cause 30-day mortality 7 (6.5) Intraprocedural death 0 (0) 296 4.4. Limitations 297 298 303 The current study did only investigate the effects of MSCT based sizing on the Edwards Sapien TAVI prosthesis, so that the results cannot be transferred to other devices. Further we did not compare MSCT to other 3-dimensional imaging techniques like 3D-TEE or MRI. Theoretically similar results could be expected and future trials need to compare the measures and outcomes of sizing approaches derived from other imaging tools. t5:1 t5:2 Table 5 Device size selection based on TEE and MSCT-annulus measurements. C U N 301 302 O R §: p-value for comparison group I vs. II, $: group I vs. III, *: Group II vs. III. AR rates and pacemaker rates were determined for 105 patients, who survived the procedure. 299 300 30 (81.1) 2 (5.4) t4:46 t4:47 F 0 (0) 0 (0) 3 (7.7) 1 (2.5) 0 (0) 2 (5.4) 1 (2.7) 1 (2.6) 2 (1.8) 4 (13.3) 0 (0) 0 (0) 6 (15.8) 81 (77.1) Stroke within 30-days 1 (2.7) 1 (2.6) 8 (7.6) No or trivial AR 1 (2.7) 2 (5.3) 1 (0.95) Worse than mild AR 5 (13.5) 5 (16.7) O 16 (15.2) 4 (10.8) 7.5 ± 1.7 R O Mild AR 2 (5.3) 29.8 ± 8.5 P t4:28 11 (10.5) 7.8 ± 1.9 D t4:25 New pacemaker 8.7 ± 2.1 E t4:22 7.7 ± 2.3 21 ± 5.5 T t4:19 Post implantation mean gradient: ΔPAo (mmHg) 9.6 ± 5.2 C t4:16 19.4 ± 10.5 E t4:13 ESTV CSA/annulus CSA oversizing ratio (%) R t4:10 26 (86.7) 2 (6.5) 2 (6.5) 1 (3.2) § $ * § $ * § $ * § $ * § $ * § $ * § $ * § $ * § $ * § $ * § $ * § $ * § $ * b0.001 b0.001 b0.001 b0.001 b0.001 b0.001 ns ns ns ns ns ns ns ns ns ns ns ns ns ns ns ns ns ns ns b0.018 ns ns p b 0.04 ns ns ns ns ns ns ns ns ns ns t4:8 t4:9 t4:11 t4:12 t4:14 t4:15 t4:17 t4:18 t4:20 t4:21 t4:23 t4:24 t4:26 t4:27 t4:29 t4:30 t4:32 t4:33 t4:35 t4:36 t4:38 t4:39 t4:41 t4:42 t4:44 t4:45 5. Conclusion 304 In the present study we demonstrated that a MSCT guided device sizing approach is safe and minimized the incidence of significant post procedural AR. The optimal oversizing range seems to be in between 15–25% based on area and 7–12 based on mean diameter measurements. We further demonstrated that 2-D echocardiography derived pre procedural measurements of the annulus underestimate the true CSA and would lead to systematic device under sizing in more than 30% of candidates. 305 308 309 6. Uncited reference 313 Q6 [19] 306 307 310 311 312 314 MSCT TEE t5:3 Valve size 23 mm 26 mm 23 mm 40 34 26 mm 1 29 mm 0 29 mm larger smaller 0 34 - 17 1 1 1 2 12 - 2 Number of patients assigned to specific device sizes based on TEE and MSCT measurements. References [1] Kodali SK, Williams MR, Smith CR, et al. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med 2012;366(18):1686–95. [2] Zahn R, Gerckens U, Grube E, et al. 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E 324 325 326 327 328 329 330 331 332 333 334 335 336 337 338 339 340 341 342 343 Q8 344 345 346 347 348 349 350 351 352 353 354 355 356 357 358 359 360 361 362 363 7 Please cite this article as: Leber AW, et al, MSCT guided sizing of the Edwards Sapien XT TAVI device: Impact of different degrees of oversizing on clinical outcome, Int J Cardiol (2013), http://dx.doi.org/10.1016/j.ijcard.2013.03.030 364 365 366 367 368 369 370 371 372 373 374 375 376 377 378 379 380 381 382 383 384 385 386 387 388 Q9 389 390 391 Q10 392 393 394 395 396 397 398 399 400 401 402 403 404