Analysis of the position of EndoAnchor implants in therapeutic use during endovascular aneurysm repair

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(2) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61. Q2. Analysis of the position of EndoAnchor implants in therapeutic use during endovascular aneurysm repair. Q5. Seline R. Goudeketting, MSc,a,b Kim van Noort, MSc,a,b Jenske J. M. Vermeulen, BSc,a,b Kenneth Ouriel, MD,c William D. Jordan Jr, MD,d Jean M. Panneton, MD,e Cornelis H. Slump, MSc, PhD,b and Jean-Paul P. M. de Vries, MD, PhD,f Nieuwegein, Enschede, and Groningen, The Netherlands; New York, NY; Atlanta,. Q1. Ga; and Norfolk, Va. ABSTRACT Objective: The aim of this study was to analyze the penetration depth, angles, distribution, and location of deployment of individual EndoAnchor (Medtronic Vascular, Santa Rosa, Calif) implants. Methods: Eighty-six primary and revision arm patients (procedural success, 53; persistent type IA endoleak, 33) treated for type IA endoleaks with a total of 580 EndoAnchor implants from a subset of the Aneurysm Treatment Using the Heli-FX Aortic Securement System Global Registry (ANCHOR) were included in this study. Procedural success was defined as the absence of a type IA endoleak on the first postprocedural computed tomography scan after the EndoAnchor implantation procedure. Endograft malapposition along the circumference was assessed at the first postoperative computed tomography scans and expressed as clock-face range and width in degrees and normalized such that the center was translated to 0 degrees. The position and penetration of each EndoAnchor implant were measured as the clock-face orientation. EndoAnchor implant penetration into the aortic wall was categorized as follows: good penetration, $2 mm; borderline penetration, <2 mm or $2-mm gap between the endograft and aortic wall; or no penetration. The orthogonal and longitudinal angles between the EndoAnchor implant and the interface plane of the aortic wall were determined. Location of deployment was investigated for each EndoAnchor implant and classified as maldeployed when it was above the fabric or in a gap >2 mm between the endograft and aortic wall due to >2-mm thrombus or positioning of the EndoAnchor implant below the aortic neck. Results: A total of 170 (29%) EndoAnchor implants had maldeployment and were therefore beyond recommended use and not useful. After EndoAnchor implantation, the procedural success and persistent type IA endoleak groups had 3 (1%) and 4 (2%) EndoAnchor implants positioned above the fabric as well as 60 (18%) and 103 (42%) placed in a gap >2 mm, respectively. The amount of EndoAnchor implants with good, borderline, and no penetration was significantly different between both groups (success vs type IA endoleak) after exclusion of maldeployed EndoAnchor implants (235 [87.4%], 14 [5.2%], and 20 [7.4%] vs 97 [68.8%], 18 [12.8%], and 26 [18.4%], respectively; P < .001). Good penetration EndoAnchor implants were more closely aligned with a 90-degree orthogonal angle than the borderline penetration and nonpenetrating EndoAnchor implants. The longitudinal angle was more distributed, which was observed through all three penetration groups. Conclusions: In this subcohort of ANCHOR patients, almost 30% of the EndoAnchor implants had maldeployment, which may be prevented by careful preoperative planning and measured intraoperative deployment. If endoleaks are due to >2-mm gaps, EndoAnchor implants alone may not provide the intended sealing, and additional devices should be considered. (J Vasc Surg 2018;-:1-10.) Keywords: EndoAnchor implant; Endovascular aneurysm repair; Abdominal aortic aneurysm; Type IA endoleak; Aneurysm neck. The Heli-FX EndoAnchor System (Medtronic Vascular, Santa Rosa, Calif) was developed to ensure durable endograft sealing and fixation as an adjunct to endovascular aneurysm repair (EVAR). Prophylactic use of EndoAnchor implants can prevent migration and the occurrence of type IA endoleaks after EVAR.1 In addition,. EndoAnchor implants can be used therapeutically to prevent persistent migration as well as to treat acute and late type IA endoleaks.2 The EndoAnchor implant’s helical design allows safe attachment of the endograft to the aortic wall, at the same time minimizing the risk of perforation of adjacent structures. When deployed. From the Department of Vascular Surgery, St. Antonius Hospital, Nieuwegeina;. Correspondence: Seline R. Goudeketting, MSc, Department of Vascular Surgery,. the MIRA Institute of Biomedical Technology and Technical Medicine, Univer-. St. Antonius Hospital, Koekoekslaan 1, 3435 CM, Nieuwegein, The Netherlands. sity of Twente, Enschedeb; the Syntactx, New Yorkc; the Department of. The editors and reviewers of this article have no relevant financial relationships to. of Vascular Surgery, Eastern Virginia Medical School, Norfolke; and the. disclose per the JVS policy that requires reviewers to decline review of any. Department of Vascular Surgery, University Medical Center Groningen, Groningen.f. Q3. (e-mail: s.goudeketting@antoniusziekenhuis.nl).. Vascular Surgery, Emory University School of Medicine, Atlantad; the Division. manuscript for which they may have a conflict of interest. 0741-5214. This research received a restricted grant from Medtronic, Inc. Author conflict of interest: J.M.P., W.D.J., and J.P.dV. are consultants and on the Scientific Advisory Board for Medtronic, Inc.. Copyright Ó 2018 Published by Elsevier Inc. on behalf of the Society for Vascular Surgery. https://doi.org/10.1016/j.jvs.2018.09.035. 1 FLA 5.5.0 DTD YMVA10211_proof 7 November 2018 4:29 pm CE RMK. 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122.

(3) 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168 169 170 171 172 173 174 175 176 177 178 179 180 181 182 183. 2. Journal of Vascular Surgery. Goudeketting et al. ---. circumferentially, EndoAnchor implants increase fixation strength to that of a surgical hand-sewn anastomosis. However, this strength can be achieved only if the EndoAnchor implants successfully penetrate the aortic wall at least 2 mm.3-5 A recent publication demonstrated the association between aortic neck characteristics and successful EndoAnchor penetration in patients with type IA endoleaks. The aortic neck diameter and neck calcium thickness were independent predictors for individual EndoAnchor implant maldeployment. Moreover, a larger number of nonpenetrating EndoAnchor implants were associated with an increased risk for type IA endoleaks.5 However, the reasons for failed EndoAnchor implant penetration in the aortic wall were not investigated. Technical errors affect successful penetration, including placement of EndoAnchor implants above the fabric, deployment at a tangential angle to the aortic wall, and placement at the site of a large gap between the aortic wall and endograft. The aim of this study was to analyze the relationship between EndoAnchor deployment and successful resolution of type IA endoleaks, including their distribution along the circumference of the neck, penetration depth into the aortic wall, and angle of penetration. This information is essential to demonstrate and to emphasize the importance of preoperative planning and intraoperative techniques, leading to improved use of EndoAnchor implants in resolving type IA endoleaks.. METHODS Selection of patients. A subset of patients from the Aneurysm Treatment Using the Heli-FX Aortic Securement System Global Registry (ANCHOR; NCT01534819) were included in this study. The study was conducted according to the Declaration of Helsinki, and informed consent was obtained for every patient. Patients from ANCHOR were included in this study only if the indication for EndoAnchor use was to treat a type IA endoleak and the first postprocedural computed tomography (CT) angiography scan was of sufficient quality (arterial-phase contrast, no slice thickness >3 mm or artifacts [eg, bare-metal stents, extension cuffs, or glue]). Patients were excluded when aortic extension cuffs were implanted at the time of EndoAnchor implantation because the sequence of the deployment of the additional material was unknown. As well, the use of an aortic extension cuff precludes the assessment of whether success might be attributable to the cuff or the EndoAnchor implants or both. Of note, the current results are not representative for the whole ANCHOR cohort because of the strict exclusion criteria. The study cohort was composed of a subset of patients from both the primary and revision arms of the ANCHOR cohort. The primary arm consisted of patients treated for an intraoperative type IA endoleak; the revision arm. 2018. ARTICLE HIGHLIGHTS d. d. d. Type of Research: Multicenter retrospective analysis of prospectively collected data of the Aneurysm Treatment Using the Heli-FX Aortic Securement System Global Registry (ANCHOR) Take Home Message: EndoAnchor treatment of type IA endoleaks resulted in a 30% rate of maldeployment, increased failure with a >2-mm gap between the endograft and aortic wall, and higher degree of success when EndoAnchors had good penetration (>2 mm). Recommendation: This study suggests that EndoAnchor penetration >2 mm is essential to successful treatment of type IA endoleaks.. comprised those with EndoAnchor implant use as a secondary intervention for type IA endoleak or endograft migration after EVAR. The study population was divided into a nonsuccessful and successful cohort on the basis of persistence of type IA endoleak after treatment of EndoAnchor implants at 1-month follow-up. Imaging studies and measurement protocol. Measurements were performed on the preprocedural and first postprocedural CT scans, using a 3mensio vascular workstation (V9.0 SP1; Pie Medical Imaging BV, Maastricht, The Netherlands). Median time between the procedure and first postprocedural CT scan was 36 days (interquartile range [IQR], 25-47 days). The median slice thickness was 2 mm (range, 0.6-3.0 mm). A center lumen line (CLL) was semiautomatically drawn through the lumen of the aorta and adjusted manually if necessary. The orifices of the renal arteries, proximal endograft fabric markers, each EndoAnchor implant, and aortic bifurcation were identified. Neck diameter was measured as the outer to outer diameter at the level of the renal arteries on the preoperative CT scan. The position and width of type IA endoleaks (gap between endograft and aortic wall) and the penetration depth and penetration angles of the EndoAnchor implants in both the primary and revision arms were measured. Because of the 3.5-mm total penetration length of the EndoAnchor implants, a gap of >2 mm between the endograft and aortic wall is beyond the recommended use for EndoAnchor implant deployment and could thereby result in maldeployment. Therefore, the eventual gap ($2 mm) between the endograft and aortic wall was measured at the position of every EndoAnchor implant. Endoleak measurements. The location where the endograft was not apposed to the aortic wall was defined as the endograft malapposition along the circumference of the proximal aortic neck. The endograft malapposition for patients with an endoleak was measured on preprocedural and postprocedural CT. FLA 5.5.0 DTD YMVA10211_proof 7 November 2018 4:29 pm CE RMK. 184 185 186 187 188 189 190 191 192 193 194 195 196 197 198 199 200 201 202 203 204 205 206 207 208 209 210 211 212 213 214 215 216 217 218 219 220 221 222 223 224 225 226 227 228 229 230 231 232 233 234 235 236 237 238 239 240 241 242 243 244.

(4) -,. Number. Goudeketting et al. 3. -. print & web 4C=FPO. 245 246 247 248 249 250 251 252 253 254 255 256 257 258 259 260 261 262 263 264 265 266 267 268 269 270 271 272 273 274 275 276 277 278 279 280 281 282 283 284 285 286 287 288 289 290 291 292 293 294 295 296 297 298 299 300 301 302 303 304 305. Journal of Vascular Surgery Volume. Fig 1. Schematic depiction in 360 degrees of the circumference and the normalization of the location of malapposition of EndoAnchor implants. A, The width (a in degrees) and the center of the malapposition zone (M). Notice that in this example, one of the EndoAnchor implants is deployed within the endoleak where there is a gap >2 mm; maldeployment due to exceeding the recommended use. The angle measurements (a) are performed on the slice perpendicular to the centerline. The width of the malapposition zone in this example is 110 degrees, and thus the center is 55 degrees. B, The malapposition zone is normalized such that the midpoint is located at 0 degrees. Therefore, the clock-face location of the EndoAnchor implants is also normalized to the center of the malapposition zone (ie, the clock-face EndoAnchor implant location minus 55 degrees).. scans for patients of the revision arm and on the postprocedural CT scans for patients in the primary arm. The circumference over which there was endograft malapposition was expressed as the clock-face range and width in degrees (Fig 1, A), normalized such that the center was translated to 0 degrees (Fig 1, B).5 EndoAnchor implant penetration. EndoAnchor implant penetration measurements were performed on the first postprocedural CT scan after EndoAnchor implant deployment. In a previous publication,5 penetration of the EndoAnchor implants was reviewed as good penetration when the EndoAnchor implant penetrated the aortic wall $2 mm, borderline penetration because of <2 mm of penetration or a gap between the endograft and aortic wall, or no penetration when there was no penetration into the aortic wall. Two experienced observers (S.G., K.N.) independently performed these measurements. A third reviewer’s (J.P.dV.) opinion was conclusive if there was a discrepancy in measurements. Maldeployment was investigated for each EndoAnchor implant and defined as EndoAnchor implants deployed above the fabric or in a gap >2 mm between the endograft and aortic wall (ie, endograft malapposition) due to thrombus >2 mm in the infrarenal neck or positioning of the EndoAnchor implant below the aortic neck (start of the aneurysm). Examples of properly deployed and maldeployed EndoAnchor implants are shown in Fig 2. Analysis of EndoAnchor implant penetration was performed for each EndoAnchor implant. They were subgrouped by whether they were implanted. within or outside the recommended use. Of note, one maldeployed EndoAnchor implant does not mean that all EndoAnchors are maldeployed in a patient. The position of the EndoAnchor implants was measured as a clock-face orientation (in degrees) on the orthogonal view, where 0 degrees was the 12-o’clock position on the aortic circumference (Fig 1, A). In subjects with a persistent type IA endoleak, the position of the EndoAnchor implants was translated according to the position of the endoleak, where 0 degrees was the center of the endoleak (Fig 1, B). The distribution of EndoAnchor implants with good, borderline, and no penetration in the successful and nonsuccessful cohorts was plotted over the circumference. In addition, the decrease in width of the endograft malapposition zone over the circumference was plotted for patients of the revision arm without procedural success. EndoAnchor implant angle analysis. EndoAnchor implant penetration angles were determined as the orthogonal and longitudinal angles between the EndoAnchor implant and the aortic wall. Orthogonal angles were measured on the orthogonal view of the CLL with the angle tool in 3mensio (Fig 3, A). The angle was determined at the interface plane of the aortic wall and the EndoAnchor implant. The longitudinal angles were measured by placing two markers on the extremities of the EndoAnchor implants (Fig 3, B, blue dots) and two markers on the aortic wall parallel to the two markers of the extremities of the EndoAnchor implants (Fig 3, B, orange dots). Coordinates were exported to. FLA 5.5.0 DTD YMVA10211_proof 7 November 2018 4:29 pm CE RMK. 306 307 308 309 310 311 312 313 314 315 316 317 318 319 320 321 322 323 324 325 326 327 328 329 330 331 332 333 334 335 336 337 338 339 340 341 342 343 344 345 346 347 348 349 350 351 352 353 354 355 356 357 358 359 360 361 362 363 364 365 366.

(5) Journal of Vascular Surgery. Goudeketting et al. ---. 2018. print & web 4C=FPO. 367 368 369 370 371 372 373 374 375 376 377 378 379 380 381 382 383 384 385 386 387 388 389 390 391 392 393 394 395 396 397 398 399 400 401 402 403 404 405 406 407 408 409 410 411 412 413 414 415 416 417 418 419 420 421 422 423 424 425 426 427. 4. Fig 2. Examples of properly deployed (A, B) and maldeployed (C-E) EndoAnchor implants. A and B, EndoAnchor implants deployed within the apposition zone and penetrating the aortic wall at least 2 mm. C, EndoAnchor implant (EA1, red arrow) deployed above the fabric (yellow markers represent the endograft fabric markers, and the upper yellow dotted line represents the location of the top of the endograft fabric). D, EndoAnchor implant (EA7, red arrow) deployed below the apposition zone (lower yellow dotted line). This EndoAnchor implant furthermore does not penetrate the aortic wall (pink dotted line). E, EndoAnchor implant (EA3, red arrow) deployed within a >2-mm gap (aortic wall is the pink dotted line).. MATLAB 2017a (MathWorks, Natick, Mass) to calculate the directional vectors of the EndoAnchor implants and the directional vector of the aortic wall (Fig 3, B, blue and orange lines). The angle between the vectors was calculated for every EndoAnchor implant. To test the intraobserver and interobserver variability, the orthogonal and longitudinal angles of 80 EndoAnchor implants were measured by two experienced observers (J.J.M.V., S.G.). Statistical analysis. Statistical analyses were performed with SPSS version 24 software (IBM Corp, Armonk, NY). P values were considered significant when two-tailed a < .05. Normality of the data was tested with the Shapiro-Wilk test. All variables had a non-normal distribution; therefore, data were represented as median (IQR). Differences in continuous variables were tested with the Mann-Whitney U test and Wilcoxon signed rank test; categorical variables were calculated with the Fisher exact test. The intraclass correlation coefficient (ICC) was used to determine the intraobserver and interobserver agreement for the orthogonal and longitudinal angles of the EndoAnchor implants to the CLL. ICC values were categorized into levels of agreement: poor (0-0.20), fair (0.21-0.40), moderate (0.41-0.60), good (0.61-0.80), and perfect (0.81-1.00). Pearson correlation coefficient was used to calculate the correlation between neck diameter and longitudinal angles.. RESULTS The analysis included a subcohort of 86 patients from ANCHOR treated for type IA endoleaks. Among these, 81.4% were male, and 61 (71%) and 25 (29%) patients were treated in the primary and revision arms of the registry, respectively. After treatment with EndoAnchor implants, 53 of the endoleaks resolved (62%) and 33 (38%) persisted through the 1-month CT angiography study. Median preoperative neck diameter was 26.5 mm (IQR, 24.2-28.8 mm). Endoleak measurements. In the primary arm, 17 patients had a persistent type IA endoleak with a median width of the malapposition zone between endograft and aortic wall of 83 degrees (IQR, 75-120 degrees). The median preoperative width of the endograft malapposition zone of the 25 patients in the revision arm was 113 degrees (IQR, 98-143 degrees). Sixteen patients (64%) had a persistent type IA endoleak after EndoAnchor implant treatment in the revision arm. Of note, the decrease in width of malapposition zone was not significant in the cases with persisting endoleaks (preoperative: median, 113 degrees [IQR, 77-148 degrees]; postoperative: median, 102 degrees [IQR, 68-133 degrees]; P ¼ .284). EndoAnchor implant penetration. A total of 580 EndoAnchor implants were deployed in the 86 subjects, 332 and 248 EndoAnchor implants in the cohorts with. FLA 5.5.0 DTD YMVA10211_proof 7 November 2018 4:29 pm CE RMK. 428 429 430 431 432 433 434 435 436 437 438 439 440 441 442 443 444 445 446 447 448 449 450 451 452 453 454 455 456 457 458 459 460 461 462 463 464 465 466 467 468 469 470 471 472 473 474 475 476 477 478 479 480 481 482 483 484 485 486 487 488.

(6) -,. Number. Goudeketting et al. 5. -. print & web 4C=FPO. 489 490 491 492 493 494 495 496 497 498 499 500 501 502 503 504 505 506 507 508 509 510 511 512 513 514 515 516 517 518 519 520 521 522 523 524 525 526 527 528 529 530 531 532 533 534 535 536 537 538 539 540 541 542 543 544 545 546 547 548 549. Journal of Vascular Surgery Volume. Fig 3. Schematic depiction of the angles between the EndoAnchor implant and aortic wall. A, Orthogonal angle (b) measurements performed with the 3mensio angle tool. B, The longitudinal angle (g) was calculated as follows: markers were placed on the extremities of the EndoAnchor implant (blue dots) and parallel to the extremities of the EndoAnchor implant on the aortic wall (orange dots). The directional vectors were created for the EndoAnchor implant (blue line) and the aortic wall (orange line). The angle between the directional vectors was calculated.. and without procedural success, respectively. The median number of EndoAnchor implants was 6 (IQR, 4-8) per patient in the 53 patients with successful resolution of the type IA endoleak and 8 (IQR, 4-10) in the 33 patients with a persistent endoleak (P ¼ .060). A total of 7 (1%) EndoAnchor implants were deployed above the fabric and a total of 163 (28%) EndoAnchor implants were deployed in a $2-mm gap between endograft and aortic wall. Figs 4 to 6 represent the clock-face distribution of EndoAnchor implants. Each dot represents an EndoAnchor implant, and the color corresponds to one of the three groups of penetration (ie, good penetration, borderline penetration, or nonpenetration). The histogram corresponds to the percentage of EndoAnchor implants per penetration group over a range of 30 degrees. Figs 4, A and 5, A show the clock-face distribution of all EndoAnchor implants in the procedural success and failure groups, respectively. Figs 4, B and 5, B show the distribution of only the EndoAnchor implants that were positioned within the recommended use and thus without maldeployment. In Fig 4, B, 3 (1%) EndoAnchor implants were deployed above the fabric and a total of 60 (18%) EndoAnchor implants (18 [56%] borderline penetration and 42 [65%] nonpenetrating) were excluded from the cohort with procedural success because of a >2-mm gap.. Four (2%) EndoAnchor implants were located above the fabric and a total of 103 (42%) EndoAnchor implants were deployed in an area with a gap $2 mm in the persistent type IA endoleak cohort: 25 (58%) borderline penetration and 78 (73%) nonpenetrating EndoAnchor implants (Fig 5, B). Of the 248 EndoAnchor implants, 110 (44.4%) were deployed in or near the endograft malapposition zone: 25 (23%) good penetration, 19 (17%) borderline penetration, and 66 (60%) nonpenetrating (Fig 5, A). After exclusion of EndoAnchor implants with maldeployment, only 25 good penetration (64%), 4 borderline penetration (10%), and 10 nonpenetrating (26%) EndoAnchor implants remain within this zone (Fig 5, B). This means that the majority of EndoAnchor implants deployed within the endograft malapposition zone were maldeployed (ie, 56 [51%] EndoAnchor implants with no penetration and 15 [17%] with borderline penetration). In 33 patients of the successful group, a median of 1 [IQR, 1-3] EndoAnchor implant was maldeployed. In the 21 patients with a persistent type IA endoleak, a median of 4 [IQR, 3-6] EndoAnchor implants were maldeployed. The amount of EndoAnchor implants with good, borderline, and no penetration was still significantly different between the procedural success and failure groups after exclusion of EndoAnchor implants with maldeployment (success: 235 [87.4%], 14 [5.2%], and 20. FLA 5.5.0 DTD YMVA10211_proof 7 November 2018 4:29 pm CE RMK. 550 551 552 553 554 555 556 557 558 559 560 561 562 563 564 565 566 567 568 569 570 571 572 573 574 575 576 577 578 579 580 581 582 583 584 585 586 587 588 589 590 591 592 593 594 595 596 597 598 599 600 601 602 603 604 605 606 607 608 609 610.

(7) Journal of Vascular Surgery. Goudeketting et al. 2018. print & web 4C=FPO. ---. Fig 4. Graphical representation of the clock-face EndoAnchor implant distribution and penetration for patients with procedural success after treatment with EndoAnchor implants. Note that 0 degrees corresponds to the anterior position on the orthogonal view. A, EndoAnchor implants (n ¼ 332) deployed in 53 patients that resulted in procedural success. B, EndoAnchor implants (n ¼ 269) of the 53 patients with procedural success where the EndoAnchor implants with maldeployment were excluded.. print & web 4C=FPO. 611 612 613 614 615 616 617 618 619 620 621 622 623 624 625 626 627 628 629 630 631 632 633 634 635 636 637 638 639 640 641 642 643 644 645 646 647 648 649 650 651 652 653 654 655 656 657 658 659 660 661 662 663 664 665 666 667 668 669 670 671. 6. Fig 5. Graphical representation of the clock-face EndoAnchor implant distribution and penetration for patients with a persistent type IA endoleak after treatment with EndoAnchor implants. Note that 0 degrees represents the center of the malapposition zone (see also Fig 1, B). The blue lines represent the median (interquartile range [IQR]) of the malapposition zone. A, Persistent type IA endoleak after EndoAnchor implant deployment (n ¼ 248) in 33 patients. B, Distribution of the EndoAnchor implants (n ¼ 141) where EndoAnchor implants with maldeployment were excluded.. [7.4%]; type IA endoleak: 97 [68.8 %], 18 [12.8%] and 26 [18.4%]; P < .001). Fig 6 shows the clock-face distribution of 135 EndoAnchor implants of the 16 revision arm patients with a persistent type IA endoleak due to malapposition of the endograft.. The endograft malapposition zone did not significantly decrease in width after EndoAnchor implant deployment. A total of 12 (50%) borderline penetration and 43 (75%) nonpenetrating EndoAnchor implants were deployed beyond recommended use. This accounts for 41% of the. FLA 5.5.0 DTD YMVA10211_proof 7 November 2018 4:29 pm CE RMK. 672 673 674 675 676 677 678 679 680 681 682 683 684 685 686 687 688 689 690 691 692 693 694 695 696 697 698 699 700 701 702 703 704 705 706 707 708 709 710 711 712 713 714 715 716 717 718 719 720 721 722 723 724 725 726 727 728 729 730 731 732.

(8) -,. Number. Goudeketting et al. 7. -. was more scattered. The distribution on the 90-degree orthogonal angle for the EndoAnchor implants with good penetration appears to be more consistent than the longitudinal angle, which was observed through all three penetration groups. Note that 43 (57%) and 126 (73%) of the borderline penetration and nonpenetrating EndoAnchor implants were beyond recommended use. After removal of these EndoAnchor implants, a clearer difference appears with regard to the orthogonal angle between the different EndoAnchor implant groups. The borderline penetration and nonpenetrating EndoAnchor implants were widely scattered, whereas the good penetration EndoAnchor implants are located close to the 90-degree orthogonal angle. No significant correlation was found between neck diameter and longitudinal angles (R ¼ 0.039; P ¼ .361).. DISCUSSION print & web 4C=FPO. 733 734 735 736 737 738 739 740 741 742 743 744 745 746 747 748 749 750 751 752 753 754 755 756 757 758 759 760 761 762 763 764 765 766 767 768 769 770 771 772 773 774 775 776 777 778 779 780 781 782 783 784 785 786 787 788 789 790 791 792 793. Journal of Vascular Surgery Volume. Fig 6. Sixteen patients treated for type IA endoleak after previous endograft implantation (revision procedures). The center of the endograft malapposition zone was normalized to 0 degrees The median (interquartile range [IQR]) of the endograft malapposition zone is represented by the solid and dotted purple and blue lines for, respectively, the preprocedural and postprocedural malapposition zones. Postoperatively, the median width of endograft malapposition was decreased (blue line), although not significantly. A total of 135 EndoAnchor implants were deployed in this subgroup.. deployed EndoAnchor implants in this group of persistent type IA endoleak patients from the revision arm. Moreover, the majority of the excluded EndoAnchor implants were in or near the endograft malapposition zone. EndoAnchor implant angle analysis. Intraobserver agreement was good for the orthogonal (0.799; 95% confidence interval [CI], 0.623-0.893) and longitudinal (0.659; 95% CI, 0.351-0.820) angle measurements. Interobserver agreement for the orthogonal and longitudinal angle measurements was perfect with an ICC of 0.881 (95% CI, 0.815-0.924) and 0.914 (95% CI, 0.866-0.945), respectively. Fig 7 shows the distribution of orthogonal and longitudinal angles of each EndoAnchor implant. Ideally, EndoAnchor implants should be deployed perpendicular to the aortic wall, meaning a 90-degree orthogonal and longitudinal angle. The EndoAnchor implants with good penetration were more centered on the 90-degree orthogonal angle, whereas this angle for borderline penetration and nonpenetrating EndoAnchor implants. This study characterized the distribution of deployed EndoAnchor implants over the circumferences of the aortic wall as well as penetration depth and angle of each EndoAnchor implant in a selected subcohort of ANCHOR patients. Almost 30% of all EndoAnchor implants did not penetrate the aortic wall and 13% had a borderline penetration. Of these EndoAnchor implants, 170 were deployed beyond recommended use, corresponding to 29% of all EndoAnchor implants deployed in this cohort. After exclusion of these maldeployed EndoAnchor implants, 87.4% vs 68.8% of the EndoAnchor implants had a good penetration in the cohorts with and without procedural success, respectively. Maldeployment of EndoAnchor implants may be overcome by careful preoperative planning to identify the apposition zone and to prevent deployment in a >2-mm gap between the aortic wall and endograft. EndoAnchor implants are not designed to overcome gaps >2 mm, which will likely be the reason that the endograft malapposition zone was not significantly decreased in width after EndoAnchor deployment in the revision group. A large proportion of borderline penetration and nonpenetrating EndoAnchor implants were positioned within this zone. The amount of EndoAnchor implants within the endograft malapposition zone with maldeployment demonstrates the likelihood that the gap in this zone was mostly >2 mm. All EndoAnchor implants positioned beyond the recommended use were therefore not useful but serve as an improvement signal where technical success can be increased through better understanding of these indications and preplanning of the case. The reason for the presence of a gap could differ between EndoAnchor implants (eg, deployment within a type IA endoleak with a >2-mm width; a >2-mm-thick thrombus load; or low positioning of the EndoAnchor implant and thus deployment in the aneurysm sac, ie, >2-mm gap). Deployment of an EndoAnchor within thrombus may furthermore decrease the. FLA 5.5.0 DTD YMVA10211_proof 7 November 2018 4:29 pm CE RMK. 794 795 796 797 798 799 800 801 802 803 804 805 806 807 808 809 810 811 812 813 814 815 816 817 818 819 820 821 822 823 824 825 826 827 828 829 830 831 832 833 834 835 836 837 838 839 840 841 842 843 844 845 846 847 848 849 850 851 852 853 854.

(9) Journal of Vascular Surgery. Goudeketting et al. ---. 2018. print & web 4C=FPO. Fig 7. The distribution of EndoAnchor implants over the orthogonal (x-axis) and the longitudinal (y-axis) angles. A, The distribution of angles for all 580 EndoAnchor implants (ie, good penetration [green], borderline penetration [orange], and no penetration [red]). B, A similar distribution for the 410 EndoAnchor implants within the recommended use.. chance of $2-mm penetration into the aortic wall (ie, good penetration), whereby adequate fixation may be inhibited. Moreover, EndoAnchor implants can encounter calcium, which can result in a fractured or nonpenetrating EndoAnchor implant (Fig 8). To overcome these problems, preoperative imaging needs careful evaluation. The clock-face locations and width of thrombus and calcium loads in the aortic neck can be calculated and translated to corresponding C-arm angles for optimal EndoAnchor implant positioning. EndoAnchor implants should be deployed in the preoperatively identified apposition zone, free from gaps and calcium load. Other reasons for EndoAnchor implant failure are mostly technical insufficiencies. First, optimal positioning of the C-arm (perpendicular to the endograft and Endoguide markers) is important throughout the intervention. During deployment of the EndoAnchor implants, the tip of the Endoguide should remain perpendicular to the fabric of the endograft.1,3,6,7 Two radiopaque markers (C-shaped and straight at, respectively, the distal tip and outer curve of the Endoguide) will aid the physician during deployment of the EndoAnchor implants. If the tip is positioned perpendicular to the aortic wall, the two markers will form a 90-degree angle. Hence, if the correct angle of the markers is created, the EndoAnchor implants will be deployed orthogonal to the aortic wall. Moreover, correct positioning of the C-arm perpendicular to the endograft fabric markers ensures that EndoAnchor implants will not be deployed above the endograft fabric. The EndoAnchor implants with good penetration were predominantly deployed within the range of a 70- to 110-degree orthogonal angle, whereas the borderline. print & web 4C=FPO. 855 856 857 858 859 860 861 862 863 864 865 866 867 868 869 870 871 872 873 874 875 876 877 878 879 880 881 882 883 884 885 886 887 888 889 890 891 892 893 894 895 896 897 898 899 900 901 902 903 904 905 906 907 908 909 910 911 912 913 914 915. 8. Fig 8. Postoperative computed tomography (CT) image after implantation of an EndoAnchor in a highly calcified region. The figure shows a nonpenetrating EndoAnchor Q4 implant at the calcium load (red arrow).. penetration and nonpenetrating EndoAnchor implants were deployed at an orthogonal angle outside of this range. If the angle between the EndoAnchor implant and the aortic wall deviates greatly from the ideal 90 degrees, the length of the EndoAnchor implant that can penetrate the aortic wall will be limited, which may be the reason for borderline penetration or nonpenetration of the EndoAnchor implant.. FLA 5.5.0 DTD YMVA10211_proof 7 November 2018 4:29 pm CE RMK. 916 917 918 919 920 921 922 923 924 925 926 927 928 929 930 931 932 933 934 935 936 937 938 939 940 941 942 943 944 945 946 947 948 949 950 951 952 953 954 955 956 957 958 959 960 961 962 963 964 965 966 967 968 969 970 971 972 973 974 975 976.

(10) 977 978 979 980 981 982 983 984 985 986 987 988 989 990 991 992 993 994 995 996 997 998 999 1000 1001 1002 1003 1004 1005 1006 1007 1008 1009 1010 1011 1012 1013 1014 1015 1016 1017 1018 1019 1020 1021 1022 1023 1024 1025 1026 1027 1028 1029 1030 1031 1032 1033 1034 1035 1036 1037. Journal of Vascular Surgery Volume. -,. Number. Goudeketting et al. 9. -. The longitudinal angle is another technical challenge, and perfect positioning will work only if the size of the Endoguide is chosen on the basis of the aortic diameter. The Endoguide gets its stability from the contralateral aortic wall during deployment of the EndoAnchor. In case of an insufficiently small radius of the Endoguide, the guide cannot get its support from the opposite aortic wall and the tip of the guide will be unstable during deployment of the EndoAnchor. This will increase the risk for wiggling and maldeployment.3 Conversely, if the radius of the Endoguide is too large, the deflectable tip cannot be positioned perpendicular to the aortic wall and the risk for maldeployment will also increase. Our previous report5 demonstrated that the aortic neck diameter is an independent risk factor of good EndoAnchor penetration, which may have been of influence as well on the longitudinal angle. Fig 7 shows a larger deviation on the longitudinal angle for all good penetration, borderline penetration, and nonpenetrating EndoAnchor implants compared with the orthogonal angles. This implies that there is a greater technical challenge in creating the correct longitudinal angle compared with the orthogonal angle. The appropriate radius size of the Endoguide is also of importance to be able to apply sufficient pressure on the endograft (and aortic wall) during deployment of the EndoAnchor implants. Lack thereof may result in an EndoAnchor implant’s sticking out into the aortic lumen, thereby having limited if any penetration into the aortic wall. To overcome problems with gaps and angles, an increase in the length of EndoAnchor implants could be an option. However, the length of the EndoAnchor implant is designed to limit the risk of penetration of surrounding structures, such as the intestine or venous structures. Another limitation is that the EndoAnchor implant does not have the full function of a tension screw and therefore is unable to pull the aortic wall to the endograft on its own. Thus, sufficient pressure on the delivery guide is necessary to create adequate penetration and to ensure apposition of the endograft to the aortic wall. Intraoperative assessment of the aortic wall and appreciation of penetration depth of EndoAnchor implants will increase successful use of EndoAnchor implants. In current practice, the physician must rely on haptic feedback of the guide to realize adequate pressure onto the aortic wall to deploy the EndoAnchor implants. Intravascular ultrasound can visualize the aortic wall during EndoAnchor deployment, and this could be used to optimize the EndoAnchor’s penetration and positioning. Alternatively, cone beam CT can be created after deployment of the EndoAnchor implants to assess the penetration of each individual EndoAnchor. Because the cone beam CT can be created intraoperatively, this can help decide whether more EndoAnchor implants should be deployed.. The costs of the Heli-FX EndoAnchor System as well as the reimbursement status differ per country. If EndoAnchor implants are correctly deployed and positioned, they can be successfully used to treat type IA endoleaks and, especially in case of small gutters, will be effective.5 This effectiveness is related to the amount of pressure that can be applied with the guide to push the endograft to the aortic wall. Importantly, the EndoAnchor implants will work sufficiently only when the endograft is pushed toward the aortic wall by the force of the applier. In other words, the EndoAnchor implants do not pull the aorta toward the endograft fabric. Longer EndoAnchor implants may not overcome this limitation and will increase the risk of penetration of adjacent structures like the caval vein or duodenum. Moreover, EndoAnchor implants can increase aortic wall apposition and prevent migration during follow-up.2,8,9 However, it is important to use the EndoAnchor implants in the same way as one would use a pledgeted suture (endovascular stitching). Thus, where sutures are used in case of a bleeding anastomosis, EndoAnchor implants can be used to resolve a type IA endoleak. However, EndoAnchor implants must be deployed at the location of the problem. If there is a malapposition zone, deployment of the EndoAnchor implants should start from the outer sides of the gap toward the center. This step by step reducing of the gap or endoleak may help overcome large sealing problems and may help ensure that the correct location of deployment is applied for the EndoAnchor implants. If endoleaks have >2-mm gaps, EndoAnchor implants alone may not provide the intended sealing, and additional devices should be considered. Moreover, the studied patients were treated solely by EndoAnchor implants, and the results show that some of the patients might have benefited from the use of proximal extension cuffs or more complex revisions like chimney or fenestrated cuffs. This seems particularly true for the patients in the revision group. Limitations of the study. EndoAnchor implant angle analysis could be challenging because of beam hardening artifacts from the metallic alloy the EndoAnchor is made of, even in high-quality CT scans. Especially in CT scans with greater slice thicknesses (1-3 mm), the extremities of the EndoAnchor implants were more difficult to identify. Moreover, 3mensio creates reconstructions of 1-mm slice thickness perpendicular to the CLL. The markers were placed on the orthogonal view of these reconstructed slices. However, the extremities of the EndoAnchor implants could be located in between two reconstructed slices. If that was the case, markers were placed either above or below the intended location, whichever was closer to the extremity of the EndoAnchor implant. Even though this might have influenced the longitudinal angle, there was a nonsignificant difference between the measurements of both observers, and the level of agreement was perfect.. FLA 5.5.0 DTD YMVA10211_proof 7 November 2018 4:29 pm CE RMK. 1038 1039 1040 1041 1042 1043 1044 1045 1046 1047 1048 1049 1050 1051 1052 1053 1054 1055 1056 1057 1058 1059 1060 1061 1062 1063 1064 1065 1066 1067 1068 1069 1070 1071 1072 1073 1074 1075 1076 1077 1078 1079 1080 1081 1082 1083 1084 1085 1086 1087 1088 1089 1090 1091 1092 1093 1094 1095 1096 1097 1098.

(11) 1099 1100 1101 1102 1103 1104 1105 1106 1107 1108 1109 1110 1111 1112 1113 1114 1115 1116 1117 1118 1119 1120 1121 1122 1123 1124 1125 1126 1127 1128 1129 1130 1131 1132 1133 1134 1135 1136 1137 1138 1139 1140 1141 1142. 10. Journal of Vascular Surgery. Goudeketting et al. ---. A hard cutoff value for each degree deviating from 90 degrees in the orthogonal or longitudinal axes on the increased risk for poor penetration was not determined because it is likely that a few degrees more or less will not make the difference between a good penetration, borderline penetration, or nonpenetrating EndoAnchor implant. The presence of a learning curve must also be considered a possible reason for maldeployment of EndoAnchor implants; the data were derived from the worldwide ANCHOR registry, including experienced but also less experienced physicians (fewer than five patients treated with EndoAnchor implants before including patients in ANCHOR). Moreover, the current results are based on a subset of patients with strict inclusion and exclusion criteria and do not represent the entire ANCHOR cohort. Follow-up analysis could provide greater clarity as to the ongoing risk of endoleak persistence after EndoAnchor deployment.. CONCLUSIONS In this subcohort of ANCHOR patients, almost 30% of the EndoAnchor implants had maldeployment, which may be prevented by careful preoperative planning and measured intraoperative deployment. If endoleaks are due to >2-mm gaps, EndoAnchor implants alone may not provide the intended sealing, and additional devices should be considered.. AUTHOR CONTRIBUTIONS Conception and design: SG, KN, JV, KO, JPV Analysis and interpretation: SG, KN, JV, KO, WJ, JP, CS, JPV Data collection: SG, KN, JV Writing the article: SG, KN Critical revision of the article: SG, KN, JV, KO, WJ, JP, CS, JPV Final approval of the article: SG, KN, JV, KO, WJ, JP, CS, JPV Statistical analysis: SG, KN Obtained funding: SG, KN, JPV. 2018. Overall responsibility: SG SG and KN contributed equally to this article and share co-first authorship.. REFERENCES 1. De Vries JP, Van de Pavoordt HD, Jordan WD Jr. Rationale of EndoAnchors in abdominal aortic aneurysms with short or angulated necks. J Cardiovasc Surg 2014;55:103-7. 2. Avci M, Vos JA, Kolvenbach RR, Verhoeven EL, Perdikides T, Resch TA, et al. The use of endoanchors in repair EVAR cases to improve proximal endograft fixation. J Cardiovasc Surg (Torino) 2012;53:419-26. 3. De Vries JP, Jordan WD Jr. Improved fixation of abdominal and thoracic endografts with use of Endoanchors to overcome sealing issues. Gefässchirurgie 2014;19:212-9. 4. Melas N, Perdikides T, Saratzis A, Saratzis N, Kiskinis D, Deaton DH. Helical EndoStaples enhance endograft fixation in an experimental model using human cadaveric aortas. J Vasc Surg 2012;55:1726-33. 5. Goudeketting SR, Van Noort K, Ouriel K, Jordan WD Jr, Panneton JM, Slump CH, et al. Influence of aortic neck characteristics on successful aortic wall penetration of EndoAnchors in therapeutic use during endovascular aneurysm repair. J Vasc Surg 2018;68:1007-16. 6. Ongstad SB, Miller DF, Panneton JM. The use of EndoAnchors to rescue complicated TEVAR procedures. J Cardiovasc Surg (Torino) 2016;57:716-29. 7. De Vries JP, Ouriel K, Mehta M, Varnagy D, Moore WM Jr, Arko FR, et al. Analysis of EndoAnchors for endovascular aneurysm repair by indications for use. J Vasc Surg 2014;60: 1460-7. 8. Jordan WD Jr, Mehta M, Ouriel K, Arko FR, Varnagy D, Joye J, et al. One-year results of the ANCHOR trial of EndoAnchors for the prevention and treatment of aortic neck complications after endovascular aneurysm repair. Vascular 2016;24:177-86. 9. Jordan WD Jr, Mehta M, Varnagy D, Moore WM Jr, Arko FR, Joye J, et al. Results of the ANCHOR prospective, multicenter registry of EndoAnchors for type Ia endoleaks and endograft migration in patients with challenging anatomy. J Vasc Surg 2014;60:885-92.e2.. Submitted May 3, 2018; accepted Sep 4, 2018.. FLA 5.5.0 DTD YMVA10211_proof 7 November 2018 4:29 pm CE RMK. 1143 1144 1145 1146 1147 1148 1149 1150 1151 1152 1153 1154 1155 1156 1157 1158 1159 1160 1161 1162 1163 1164 1165 1166 1167 1168 1169 1170 1171 1172 1173 1174 1175 1176 1177 1178 1179 1180 1181 1182 1183 1184 1185 1186.

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