Billi Tatum

Early report from an investigator-initiated investigational device exemption clinical trial on physician-modified endovascular grafts

OBJECTIVE To determine whether a physician-modified endovascular graft (PMEG) is a safe and effective method for treating patients with juxtarenal aortic aneurysms who are deemed unsuitable for open repair. METHODS A nonrandomized, prospective, consecutively enrolling investigational device exemption clinical trial was used. Data collected on patients treated with PMEG between April 2011 and August 2012 were analyzed. Subjects were followed with computed tomography, visceral duplex, and four-view X-ray at 30 days, 6 months, and 1 year. The protocol was designed to include follow-up to 5 years. The primary safety end point was the proportion of subjects who experienced a major adverse event (MAE) within 30 days of the procedure. The primary efficacy end point was the proportion of subjects experiencing treatment success. RESULTS During the 16-month study period, 28 patients were consented and 26 underwent endovascular repair using PMEGs. Anatomic, operative details, and length of stay were recorded and included aneurysm diameter (mean, 62.5 mm), proximal neck length (mean, 4.4 mm), graft manufacture time (mean, 59.7 minutes), procedure time (mean, 169 minutes), fluoroscopy time (mean, 42.8 minutes), total contrast usage (mean, 63 mL), estimated blood loss (mean, 221 mL), and length of hospital stay (mean, 4.9 days). There were 63 fenestrations created for 48 renal arteries and 15 superior mesenteric arteries. Renal artery fenestrations were stented whenever possible (96%) and superior mesenteric artery fenestrations were all left unstented. There were no unanticipated adverse device events, no MAEs, and only a single minor adverse device event treated with a successful reintervention. At 30 days, there were no type I or III endoleaks and only four type II endoleaks (15.4%). Two patients died during the study period, one at day 23 from respiratory failure (in-hospital and 30-day mortality = 3.8%) and one at day 210 from urosepsis and congestive heart failure. MAEs occurred in 11.5% of patients at 30 days. The primary efficacy end point was achieved in 87.5% of patients (technical success 100%, freedom from migration, rupture or conversion, type I or III endoleaks, or sac enlargement = 100%, 100%, 87.5%, and 87.5%, respectively). CONCLUSIONS These preliminary data suggest that endovascular repair with PMEG is safe and effective for managing patients with juxtarenal aortic aneurysms. Endovascular repair with PMEG has acceptable early rates of morbidity, mortality, and endoleak. This endovascular aortic strategy is particularly appealing for those patients presenting with symptomatic or ruptured aortic aneurysms until reliable off-the-shelf solutions become widely available.

Midterm results from a physician-sponsored investigational device exemption clinical trial evaluating physician-modified endovascular grafts for the treatment of juxtarenal aortic aneurysms.

Objective: The objective of this study was to report midterm results of an ongoing physician‐sponsored investigational device exemption pivotal clinical trial using physician‐modified endovascular grafts (PMEGs) for treatment of patients with juxtarenal aortic aneurysms who are deemed unfit for open repair. Methods: Data from a nonrandomized, prospective, consecutively enrolling investigational device exemption clinical trial were used. Data collection began on April 1, 2011, and data lock occurred on May 31, 2015, with outcomes analysis through December 31, 2015. Primary safety and efficacy end points were used to measure treatment success. The primary safety end point was defined as the proportion of subjects who experienced a major adverse event within 30 days of the procedure. The primary efficacy end point was the proportion of subjects who achieved treatment success. Treatment success required the following at 12 months: technical success, defined as successful delivery and deployment of a PMEG with preservation of those branch vessels intended to be preserved; and freedom from type I and III endoleak, stent graft migration >10 mm, aortic aneurysm sack enlargement >5 mm, and aortic aneurysm rupture or open conversion. Results: During the 50‐month study period, 64 patients were enrolled; 60 began the implant procedure and 59 received the PMEG implant. Aneurysm anatomy, operative details, and lengths of stay were recorded and included aneurysm diameter (mean, 65.9 mm; range, 49‐104 mm), proximal seal zone length (mean, 40.8 mm; range, 18.9‐72.2 mm), graft manufacture time (mean, 55.1 minutes), procedure time (mean, 156.8 minutes), fluoroscopy time (mean, 39.6 minutes), contrast material use (mean, 75.3 mL), estimated blood loss (mean, 213 mL), and length of hospital stay (mean, 4.1 days) with intensive care unit length of stay (mean, 2.2 days). There were 145 fenestrations made for 110 renal arteries and 38 superior mesenteric arteries (SMAs). One patient had an SMA stent placed before the procedure for severe stenosis, and one subject had the SMA stented during the procedure. Renal arteries were stented whenever possible (93%). There were 102 stented renal arteries in 58 patients. There were no open conversions or explantations. Thirty‐day mortality was 5.1% (3/59). There were zero type Ia, one type Ib, and two type III endoleaks during follow‐up treated with successful reintervention. The overall rate of major adverse events at 30 days was 11.9%. The primary efficacy end points were achieved in 94.1% of patients. Conclusions: These midterm results are favorable and verify our early report that endovascular repair with PMEG is safe and effective for managing patients with juxtarenal aortic aneurysms. PMEG has exceptional midterm rates of morbidity, mortality, and endoleak and may outperform standard endovascular aneurysm repair with favorable anatomy. In patients who are poor open surgical candidates who present with symptomatic or ruptured juxtarenal aortic aneurysms, PMEG continues to be an extremely appealing option as reliable off‐the‐shelf solutions are not widely available. Preoperative planning remains the key ingredient for success with use of these techniques.

Aortic neck dilation is not associated with adverse outcomes after fenestrated endovascular aneurysm repair: Midterm results from an investigational device exemption clinical trial

Objective Long‐term outcomes after endovascular aneurysm repair (EVAR) are threatened by aortic neck dilation (AND), graft migration, and subsequent endoleak development. The aim of this study was to determine the rate of AND and the occurrence of endoleaks after fenestrated EVAR of juxtarenal aneurysms with physician‐modified endovascular grafts (PMEGs). Methods The study included 77 patients presenting with asymptomatic and ruptured juxtarenal abdominal aortic aneurysms treated with PMEGs who received radiologic follow‐up. Analysis of computed tomography images took place on a three‐dimensional workstation (TeraRecon, San Mateo, Calif). Aortic neck diameter was measured before and after EVAR at the lowest patent renal artery outer wall to outer wall. Significant AND was defined as >3‐mm increase between baseline and follow‐up, and sac regression >5 mm was considered significant. The patient’s 1‐month initial postoperative computed tomography measurement was considered baseline. The rate of AND was measured by comparing the baseline measurement with measurements at 6 months, 12 months, and annually thereafter up to 4 years. Results In this cohort of patients, 75% were men with a mean age of 74 ± 7.9 years. Median preoperative aneurysm size was 62 (57‐73) mm, and median follow‐up was 12 (3.5‐30) months. Mean endograft oversizing was 17% ± 12.5%, and mean seal zone length was 41 ± 11 mm. At 1‐year follow‐up, the median aortic neck increase was 1.7 (0‐3) mm. Maximum aneurysm size decreased dramatically during the first postoperative year, with significant sac regression in 65% of the patients. Aortic neck diameter at 1 year did correlate positively with the percentage of device oversizing. No other correlations were found. During the 4‐year follow‐up, there were no cases of type IA endoleaks. Conclusions AND does not influence outcome after endovascular repair of juxtarenal aneurysms using PMEGs. These midterm results support the applicability of PMEGs in juxtarenal aneurysm repair.

A Reliable Method for Renal Volume Measurement and Its Application in Fenestrated Endovascular Aneurysm Repair

Conclusions: In patients undergoing AVF surgery for hemodialysis access, delaying surgery for additional preoperative evaluation is associated with an increase in ED visits, an increase in CVC-related interventions, and an increase in general hospital visits compared with those without surgery delay. Only a small minority of the delayed surgery group underwent meaningful interventions to optimize surgery. These findings suggest that delaying surgery for further evaluation may be detrimental