Mark F. Fillinger’s research while affiliated with Dartmouth–Hitchcock Medical Center and other places

Objective: The timing of TEVAR after the onset of uncomplicated acute type B aortic dissection (UATBAD) remains controversial. The objective of this study was to evaluate the SVS VQI post-approval study (VQI PAS) data for the impact of TEVAR timing for UATBAD on early and late outcomes, including mortality, procedural complications and long-term reintervention. Methods: The VQI PAS utilized for this analysis includes a total of 606 patients. Patients with UATBAD (defined as those without rupture or malperfusion) exclusive of cases categorized as emergent (N=206), were divided into groups defined by the SVS/STS reporting guidelines based on timing of treatment after the onset of dissection: within 24 hours (N=8), 1-14 days (N=121), and 15-90 days (N=77). Univariate and multivariable analysis was used to determine differences between timing groups for postoperative mortality, in-hospital complications, and reintervention. Results: Demographics and comorbid conditions were very similar across the 3 TEVAR timing groups. Notable differences included a higher prevalence of baseline elevated creatinine (>1.8mg/dL)/chronic ESRD and designation as "urgent" in the <24-hour group, as well as a higher rate of pre-operative beta-blocker therapy in the 1-14 day group. Post-operative stroke, CHF, and renal ischemia were more common in the <24-hour group, without an increase in mortality. Unadjusted 30-day mortality across groups was lowest in the early TEVAR group (0%, 3.3%, 5.2% P=0.68), as was 1-year mortality (0%, 8.3%, 18.2%; P=0.06), although not statistically different at any time point. Reintervention out to three years was not different between the groups. Multivariable analysis demonstrated the need for a postoperative therapeutic lumbar drain to be the only a predictive risk factor for mortality (HR=7.595, 95% CI 1.730-33.337, P=0.007). When further subdivided into patients treated 1-7 days or 8-14 days after dissection, findings were similar. Conclusions: UATBAD patients treated within 24 hours were unusual (N=8), too small for valid statistical comparison, and likely represent a high-risk subgroup, which is manifested in a higher risk of complications. Although there was a trend towards improved survival in the acute (1-14 day phase), outcomes did not differ compared to the subacute (15-90 days) phase with relation to early mortality, post-operative complications or one-year survival. These data suggest that proper selection of patients for early TEVAR can result in equivalent survival and early outcomes.

Background: Hybrid debranching repair of pararenal and thoracoabdominal aortic aneurysms was initially designed as a better alternative to standard open repair, addressing the limitations of endovascular repair involving the visceral aorta. We reviewed the collective outcomes of hybrid debranching repairs using extra-anatomic, open surgical debranching of the renal-mesenteric arteries, followed by endovascular aortic stenting. Methods: Data from patients who underwent hybrid repair in 14 North American institutions during 10 years were retrospectively reviewed. Society of Vascular Surgery scores were used to assess comorbidity risk. Early and late outcomes, including mortality, morbidity, reintervention, and patency were analyzed. Results: A total of 208 patients (118 male; mean age, 71±8 years old) were treated by hybrid repair with extraanatomic reconstruction of 657 renal and mesenteric arteries (mean 3.2 vessels/patient). Mean aneurysm diameter was 6.6±1.3 cm. Thoracoabdominal aortic aneurysms were identified in 163 (78%) patients and pararenal aneurysms in 45 (22%). A single-stage repair was performed in 92 (44%) patients. The iliac arteries were the most common source of inflow (n=132; 63%), and most (n=150; 72%) had 3 or more bypasses. There were 30 (14%) early deaths, ranging widely across sites (0%-21%). A Society of Vascular Surgery comorbidity score >15 was the primary predictor of early mortality (P<0.01), whereas mortality was 3% in a score ≤9. Early complications occurred in 140 (73%) patients and included respiratory complications in 45 patients (22%) and spinal cord ischemia in 22 (11%), of whom 10 (45%) fully recovered. At 5 years, survival was 61±5%, primary graft patency was 90±2%, and secondary patency was 93±2%. The most significant predictor of late mortality was renal insufficiency (P<0.0001). Conclusions: Mortality after hybrid repair and visceral debranching is highly variable by center, but strongly affected by preoperative comorbidities and the centers' experience with the technique. With excellent graft patency at 5 years, the outcomes of hybrid repair done at centers of excellence and in carefully selected patients may be comparable (or better) than traditional open or even totally endovascular approaches. However, in patients already considered as high-risk for surgery, it may not offer better outcomes.

Objectives Aortic aneurysms involving aortic arch vessels are anatomically unsuitable for standard thoracic endovascular repair (TEVAR) without cervical debranching of the arch vessels. We report three-year outcomes of a single-branched thoracic endograft, following previous publication of perioperative and one-year outcomes. Design This is a multicenter feasibility trial of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE), a thoracic endovascular graft incorporating a single retrograde branch for aortic arch vessel perfusion. Methods The first study arm enrolled patients with intact descending thoracic aortic aneurysm extending to the distal arch with left subclavian artery incorporation (LSA, zone 2). The second arm enrolled patients with arch aneurysms requiring incorporation of the left carotid or innominate artery (zone 0/1) and extra-anatomic surgical revascularization of the remaining aortic arch vessels. Outcomes at three years are reported. Results The cohort comprised forty patients (31 zone 2, 9 zone 0/1). The majority were male (52%). Mean follow up was 1408±552 days in the zone 2 and 1187±766 days in the zone 0/1 cohort. During 3-year follow-up there was no device migration, fracture, or aortic rupture in either arm. In the zone 2 arm, freedom from reintervention was 97% at 1 and 3 years but there were two side branch occlusions. Two patients had aneurysm enlargement >5mm without documented endoleak or reintervention. Freedom from mortality at 1 and 3 years was 90% and 84%. In the zone 0/1 arm there were no reinterventions, loss of branch patency, or aneurysm enlargement at 3 years. Cerebrovascular events occurred in three patients during follow-up, two unrelated to the device or procedure, and one of unknown relationship. Two patients in this arm died during the follow-up period, both unrelated to the procedure or the aneurysm. Conclusions Initial 3-year results of the TBE device for endovascular repair of arch aneurysms show favorable patency and durability with low rates of graft-related complications.

Background Retrograde dissection (RD) can be a serious complication following TEVAR, with retrograde type A dissection (RTAD) being particularly life-threatening. Prior studies have suggested that treatment timing, anatomic characteristics, device selection and procedural conduct of TEVAR performed for type B aortic dissection (TBAD) could mitigate this complication. The VQI TEVAR for Dissection Registry is an ongoing project meant to satisfy FDA requirements for post-market approval surveillance of the Gore CTAG, Medtronic (MDT) Valiant and Cook Medical dissection devices, and provides a unique source of evaluation for RTAD in a prospectively collected real-world registry. Methods 588 consecutive patients at 49 institutions treated with TEVAR for acute (N=336, <30 days) and chronic (N=252, ≥30 days) TBAD were included. Occurrence of RD as reported by the participating centers, and deidentified source documents were reviewed and confirmed independently by two authors (AB and GW). Demographics, procedural/device data and anatomic considerations were evaluated, and devices were grouped in a deidentified manner as Gore, Medtronic and other. Results Median follow-up was 889 days (Median 658 days), and 408 patients have completed follow-up past one year. Nineteen (3.2%) RD cases were identified, 9 of which were treated for acute and 10 for chronic dissection, a 2.7% and 4.0% incidence, respectively (P=.48 acute vs. chronic). Of the 19 RD cases, 15 were RTAD, 6 of which were treated for acute and 9 for chronic dissection, a 1.8% and 3.6% incidence, respectively (P=.19 acute vs. chronic). There were five intraoperative RD (4 of which were RTAD), and the median times to RD and RTAD were 62 and 69 days, respectively (range: 0 to 1600 days). In the 15 patients with RTAD, 12 were treated with surgical repair, 2 with no repair, and 1 unknown – with an overall mortality of 33.3% (N=5 of 15). Factors associated with RTAD included more extensive dissection (mean 5.6 zones No RTAD vs 8.5 zones RTAD; P=.001), female sex (28.3% Female No RTAD vs 53.3% Female RTAD; P=.04), and non-white race (62.7% White No RTAD vs 33.3% White RTAD; P=.05). Mean oversizing was not significantly different for No RTAD vs RTAD patients (14.0% vs 14.2%, P=.92). Device type is anonymized in this project, but there was no significant difference between Gore, MDT, and all other devices. Conclusion The rate of RD in this real-world post-approval project is consistent with previously published studies, including highly controlled pivotal studies. Device type was not predictive of this complication, and newly identified risk factors for RTAD include more extensive dissection and a trend towards higher risk for female sex and non-white race.

Introduction Thoracic endovascular aortic repair (TEVAR) of proximal aortic arch pathology provides a less-invasive treatment option for high-risk patients ineligible for open arch reconstruction. However, the fiscal impact of these techniques remains unclear. Therefore, our objective was to characterize the mid-term outcomes after Zone 0 and Zone 1 TEVAR and describe the associated technical costs, revenues, and net margins at a single tertiary medical center. Methods We examined all patients who underwent TEVAR between April 2011 and August 2019 via retrospective chart review. Patients were categorized by proximal endograft extent to identify Zone 0 or Zone 1 repairs. Procedural characteristics and outcomes were described. Technical costs, revenues, and margins were obtained from the hospital finance department. Results We identified 10 patients (6 Zone 0, 4 Zone 1) who were denied open arch reconstruction. Patients were predominantly female (n=8; 80%) and the mean age was 72.8±5.5 years. TEVAR was performed in 5 asymptomatic patients, urgently in 3 symptomatic patients, and emergently in 2 ruptured patients. TEVAR plus extra-anatomic bypass was performed in 4 patients. Another 4 patients also received parallel stent-grafting while one patient received a branched thoracic endograft and yet another an in-situ laser fenestration followed by branch stent grafting. Within the 30-day postoperative period, 1 patient experienced stroke and 1 patient died. Bypass and branch vessel patency were 100% through the duration of follow-up (mean 19.3 months). Mean total technical cost associated with all procedures or repair stages was 105,164±59,338 while mean net technical margin was -25,055±18,746. The net technical margin was negative for 9 patients. Conclusions Endovascular repair of the proximal aortic arch is associated with good mid-term outcomes in patients considered too high-risk for open repair. However, reimbursement does not adequately cover treatment cost, with net technical margins being negative in nearly all cases. To remain financially sustainable, efforts should be made to both optimize aortic arch TEVAR delivery as well as advocate for reimbursement commensurate with associated costs.

Backgound -: Thoracic endovascular aortic repair (TEVAR) has radically transformed the treatment of descending thoracic aortic aneurysms. However, when aneurysms involve the aortic arch in the region of the left subclavian artery, branch vessel preservation must be considered. Branched aortic endografts provide a new option to maintain branch patency. Methods: - Six investigative sites enrolled 31 patients in a non-randomized, prospective investigational device exemption (IDE) feasibility trial of a single branched aortic endograft for ; management of aneurysms that include the distal aortic arch. The GORE® TAG® Thoracic ; Branch Endoprosthesis (TBE; W.L. Gore & Associates, Inc., Flagstaff, AZ) an investigational device, allows graft placement proximal to the left subclavian artery and incorporates a single side branch for left subclavian perfusion. Results: - All 31 (100%) patients had a successful implantation of the investigational device in landing zone 2. Men slightly outnumbered women (51.6%). Average age of 74.1 +/- 10.4 years. Aneurysm morphology was fusiform in 12 and saccular in 19, with a mean maximum aortic diameter of 54.8 +/- 10.9 mm. Mean follow up for the cohort is 25.2 +/- 11.1 months; patient outcomes are reported here at 1 month and 1 year. At one month, side branch patency was 100% and freedom from core lab reported device related endoleak (type I and III) was 96.7% without 30-day death or permanent paraplegia. One patient experienced a procedure-related stroke. Through one year, there have been five patient deaths, none device or procedure-related (CEC adjudicated); one thoracic re-intervention; no conversions; no reported aneurysm growth (Core lab), and one loss of side branch patency diagnosed of the left subclavian artery in an asymptomatic individual by CT imaging at 6 months with no reported subsequent adverse events due to loss of patency. Endoleaks were Core lab reported in five patients at 12 months (two type II and three were indeterminate). Conclusions: - This IDE feasibility study reports the preliminary study results of a single side branch endograft to treat patients with proximal descending thoracic aortic aneurysms.