Retrograde Type A Dissection in the Vascular Quality Initiative TEVAR for Dissection Post approval Project
Adam W. Beck1, Grace J. Wang2, Joseph V. Lombardi3, Rodney A. White4, Jack Cronenwett5, Richard P. Cambria6, Ali Azizzadeh7
1University of Alabama at Birmingham, Birmingham, AL, 2University of Pennsylvania, Philadelphia, PA, 3Cooper Health, Camden, NJ, 4Memorial Care Long Beach Heart & Vascular Surgery, Long Beach, CA, 5Dartmouth-Hitchcock Medical Center, Lebanon, NH, 6St. Elizabeth's Medical Center, Boston, MA, 7Cedars-Sinai, Los Angeles, CA
Background:Retrograde type A dissection (RTAD) is a feared complication following TEVAR. Prior studies have suggested that treatment timing, anatomical characteristics, device selection and procedural conduct of TEVAR performed for type B aortic dissection (TBAD) could mitigate this risk. The VQI TEVAR for Dissection Registry is an ongoing project meant to satisfy FDA requirements for post-market approval surveillance of the Gore CTAG and Medtronic (MDT) Valiant devices, and provides a unique source of evaluation for RTAD in a prospectively collected real-world registry.
Methods:Project data have been collected for 595 consecutive patients at 49 institutions who have undergone TEVAR for acute (N=338, <30 days) and chronic (N=257, ≥30 days) TBAD. Patients were evaluated for the occurrence of RTAD as reported by the participating centers, and deidentified source documents of cases of RTAD were reviewed and confirmed independently by two authors (AB and GW). Demographics, procedural/device data and anatomic considerations were evaluated in those with and without RTAD.
Results:The mean follow-up was 373 days, and 435 patients have completed one year of follow-up. A total of 20 (3.4%) RTAD cases were identified from the entire cohort. 10 of these were treated for acute and 10 for chronic dissection, equating a 1.7% and 1.7% incidence, respectively (P=.53 acute vs. chronic). There were two intraoperative RTAD, and the median time to RTAD was 248 days (range: 0 to 1105 days). 1 patient died from RTAD without treatment on POD2 from TEVAR, while 10 patients underwent open repair, with an operative mortality of 10% (N=1). Factors associated with RTAD included more extensive dissection, measured by zones traversed by dissection (5.5 zones non-RTAD vs 8.2 zones RTAD; P=.0009), and a trend towards a larger proximal landing zone (mean 31.3 mm no-RTAD vs. 33.0 mm RTAD; P=.157). Median oversizing was not significantly different for non-RTAD (12.9%) vs RTAD (12.4%) patients (P=.839). Device type is anonymized in this project, but there was no significant difference between Gore, MDT and all other devices, which were grouped for analysis.
Conclusion: The rate of RTAD in this real-world post-approval project is consistent with previously published studies, and device type was not predictive of RTAD. Newly identified risk factors include more extensive dissection and a trend towards larger proximal landing zone. It appears that the
practice pattern of less oversizing with dissection treatment has disseminated, mitigating this previously identified risk factor.
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