
==== Front
Ann Surg
Ann Surg
SLA
Annals of Surgery
0003-4932
1528-1140
Lippincott Williams & Wilkins Hagerstown, MD

38920026
ANNSURG-D-24-00935
10.1097/SLA.0000000000006422
00010
3
Papers of the 144th ASA Annual Meeting
Long-Term Results of Physician-Modified Endografts for the Treatment of Elective, Symptomatic, and Ruptured Juxtarenal Abdominal Aortic Aneurysms
Starnes Benjamin W. MD STARNES@UW.EDU

Zettervall Sara MD, MPH szetterv@uw.edu

Larimore Allison RN alari@uw.edu

Singh Niten MD singhn2@uw.edu

Department of Surgery, Division of Vascular Surgery, University of Washington, Seattle, WA
starnes@uw.edu.
10 2024
26 6 2024
280 4 633639
Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc.
2024
https://creativecommons.org/licenses/by-nc-nd/4.0/ This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. http://creativecommons.org/licenses/by-nc-nd/4.0/

Objective:

The objective of this study was to report long-term results of an ongoing physician-sponsored, investigational device exemption (IDE) pivotal clinical trial using physician-modified endovascular grafts (PMEGs) for the treatment of patients with juxtarenal aortic aneurysms.

Methods:

Data from a nonrandomized, prospective, consecutively enrolling IDE clinical trial were used. Data collection began on April 1, 2011, and data lock occurred on January 2, 2024, with outcomes analysis through December 31, 2023. Primary safety and effectiveness end points were used to measure treatment success. The safety end point was defined as the proportion of subjects who experienced a major adverse event within 30 days of the procedure. The effectiveness 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 intended branch vessels; 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:

Over the 12-year study period, 228 patients were enrolled; 205 began the implant procedure, and 203 received PMEG. Thirteen patients withdrew prior to PMEG. Two withdrew (<1.0%) after failure to deploy due to tortuous iliac anatomy and are tracked as intent to treat, and a total of 24 withdrew after receiving the PMEG implant. Forty-four patients died during the study period. A total of 14 were deemed lost to follow-up. Fifty-nine completed the 5-year follow-up period, and 62 remain active in follow-up visits.

Aneurysm anatomy, operative details, and lengths of stay were recorded and included: aneurysm diameter (mean, 67.5 mm; range, 49–124 mm), proximal seal zone length (mean, 41.6 mm; range, 18.9–92.9 mm), graft modification time (mean, 48.7 min), procedure time (mean, 137.7 min), fluoroscopy time (mean, 33.8 min), contrast material use (mean, 93.0 mL), estimated blood loss (mean, 118.8 mL), length of hospital stay (mean, 3.7 d), and intensive care unit length of stay (mean, 1.6 d).

A total of 575 fenestrations were created for 387 renal arteries, 181 superior mesenteric arteries (SMAs), and 7 celiac arteries. Renal arteries were in 96% of patients and included 410 renal artery stents in 203 patients. The SMA was stented as needed and included one patient with an SMA stent placed before the procedure, 19 during the procedure, and 2 patients who underwent stent placement after the procedure. There were no open conversions or device migrations and 1 partial explant due to late distal graft occlusion. Three ruptures (1.4%) were recorded on days 830, 1346, and 1460. There was 1 presumed graft infection at 750 days (<0.5%) treated with? Thirty-day all-cause mortality was 2.9% (6/204). One type Ia, 1 type Ib, and 7 type III endoleaks were identified during follow-up and treated with successful reintervention at the 1-year period. The overall rate of major adverse events at 30 days was 15% (29/194). Technical success was 93.7%, and overall treatment success was 82.6%.

Conclusions:

PMEG can be performed with low rates of long-term morbidity and mortality, confirming our early and midterm reports that endovascular repair with PMEG is safe, durable, and effective for managing patients with juxtarenal aortic aneurysms. While historically considered experimental, these results suggest that PMEG is a safe and durable option and should be considered for patients where off-the-shelf devices are not available.

Keywords:

physician modified endografts
juxtarenal abdominal aortic aneurysm
fenestrated
OPEN-ACCESSTRUE
==== Body
pmcEndovascular abdominal aortic aneurysm repair (EVAR) has been part of the vascular surgery lexicon for over 3 decades, with Juan Carlos Parodi credited with the first human implant in the Western Hemisphere in 1991.1 Newer generations of devices have led to improved outcomes with better anatomic fixation and lower profile delivery systems. Fenestrated EVAR (FEVAR) was introduced by John Lennon Anderson in 2005.2 In FEVAR, “fenestra,” Latin for “windows,” were created for target vessels within the desired seal zone of the visceral aortic segment and could include fenestrations for renal arteries, the superior mesenteric artery, the celiac artery or all 4 (or more) vessels. FEVAR was not widely available in the United States until the Food and Drug Administration (FDA) approval of a commercially available fenestrated device in 2012. This led several investigators in the early 2000s to seek Investigational Device Exemption (IDE) clinical trials with the FDA in order to be able to modify commercially available EVAR devices with fenestrations to treat a wider range of patients who would otherwise be deemed unfit for standard EVAR or open repair or were unable to wait the requisite time for the fenestrated graft to be custom-manufactured. The University of Washington coined the term “physician-modified endografts” or “PMEG” in April, 2007 to describe those commercially available EVAR devices that were modified by the interventionalist performing the index procedure. This novel treatment approach was found to be safe and effective in early and mid-term results from PMEGs performed under an IDE at the University of Washington and has been previously published.3–5

OBJECTIVE

The primary objectives of this study were to determine whether PMEGs are a safe and effective method of treating patients with elective, symptomatic, or ruptured juxtarenal aortic aneurysms in those patients considered to be unsuitable candidates for open surgical repair and have limited or no options for treatment. Secondary objectives were to determine the long-term outcomes of subjects undergoing treatment in this unique data set.

METHODS

Data from a nonrandomized, prospective, consecutively enrolling IDE clinical trial (IDE #G100336) were used. Data collection began on April 1, 2011, and data lock occurred on January 2, 2024, with outcomes analysis through December 31, 2023. Primary safety and effectiveness end points were used to measure treatment success. The safety end point was defined as the proportion of subjects who experienced a major adverse event within 30 days of the procedure. Major adverse events included death, myocardial infarction, stroke (excluding TIA), renal failure (excluding renal insufficiency), respiratory failure (excluding COPD or pulmonary complications), paralysis (excluding paraparesis), bowel ischemia, and procedural blood loss (≥1000 mL). The effectiveness 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 intended branch vessels; 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.

Our device modification procedure has been widely described in previous reports.3–6 At the time of the index surgical procedure, a properly sized EVAR device was unsheathed in a sterile field in an operating theater. Precise measurements for target vessels were taken from DICOM images imported into TeraRecon Imaging Software (Durham, NC) and transmitted onto the bare endograft. Care was taken to eliminate competing struts crossing fenestrations. Ophthalmic cautery was used to create the fenestrations and heat seal the polyester fabric. Only endografts with polyester fabric were used as heat sealing is not possible with Polytetrafluoroethylene (PTFE). Gold markers from 15 mm Amplatz Gooseneck Snares (Medtronic, Minneapolis, MN) were sewn around the fenestrations to create a radiopaque marker for ease of visualization during the implant procedure. A variety of techniques were utilized to re-sheath the newly fenestrated device (Fig. 1).

FIGURE 1 Physician-modified endograft.

RESULTS

During the 140-month study period, 228 patients were enrolled; 205 began the implant procedure, and 203 received PMEG. There were 10 screen failures, while 13 withdrew before PMEG. Four patients withdrew from the trial before the procedure, and 1 patient each had screen failures for the following 6 reasons: aberrant anatomy, insurance denial, unable to complete the required follow-up, open surgical candidate, underwent standard EVAR, and had other endovascular procedures. Two withdrew after failure to deploy due to tortuous iliac anatomy and are tracked as intent to treat, and a total of 24 withdrew after receiving the PMEG implant. Each of the patients who had failed to implant the device had 3 defining characteristics: severe morbid obesity, severe iliac tortuosity, and significant aortic angulation. Forty-four patients died during the study period. A total of 14 were deemed lost to follow-up. Fifty-nine completed the 5-year follow-up period, and 62 remain active in follow-up visits.

Baseline subject demographics are listed in Table 1. As in most other studies of abdominal aortic aneurysms, the majority of subjects were male (77%) and white (96.3%). The average age was 75.6 years (+/−7.6).

TABLE 1 Baseline Subject Demographics

No. Subjects Consented	228	
No. subjects who completed screening process	N=217	
Gender	
 Male	167 (77.0)	
 Female	50 (23.0)	
Ethnicity	
 Not Hispanic or Latino	216 (99.5)	
 Hispanic or Latino	1 (0.5)	
 Unknown	0	
Race	
 White or Caucasian	209 (96.3)	
 Black or African American	2 (0.9)	
 Asian	4 (1.8)	
 American Indian or Alaskan Native	1 (0.5)	
 Native Hawaiian or Other Pacific Islander	1 (0.5)	
 Other/unknown	0 (0.0%) / 0 (0.0%)	
Age (y)	
 Mean (SD)	75.6 (7.6)	
 Median	75	
 Range	59, 93	
Weight (kg)	
 Mean (SD)	86.4 (18.8)	
 Median	85.20	
 Range	40.2, 158.0	
Height (cm)	
 Mean (SD)	173.7 (10.1)	
 Median	175.3	
 Range	152.4, 200.7	

Subject comorbidities are listed in Table 2 and represent the typical comorbidities of this patient population. A total of 79.7% of subjects had hypertension, with 83.9% listed as current or former smokers.

TABLE 2 Subject Comorbidities

No. subjects completing the screening process	217, n (%)	
Cigarette smoking	
 Current	59 (27.2)	
 Former	123 (56.7)	
 Never	35 (16.1)	
Hypertension	173 (79.7)	
Hypercholesterolemia	174 (80.2)	
Coronary artery disease	96 (44.2)	
Coronary artery bypass surgery	33 (15.2)	
Renal insufficiency	47 (21.7)	
Congestive heart failure	21 (9.7)	
Stroke	25 (11.5)	
Transient ischemic attack	16 (7.4)	
Carotid disease	24 (11.1)	
Peripheral vascular disease	33 (15.2)	
Diabetes	38 (17.5)	
Chronic obstructive pulmonary disease	71 (32.7)	

Aneurysm anatomy, operative details, and lengths of stay were recorded and included: aneurysm diameter (mean, 67.5 mm; range, 49–124 mm), proximal seal zone length (mean, 41.6 mm; range, 18.9–92.9 mm), graft modification time (mean, 48.7 min), procedure time (mean, 137.7 min), fluoroscopy time (mean, 33.8 min), contrast material use (mean, 93.0 mL), estimated blood loss (mean, 118.8 mL), length of hospital stay (mean, 3.7 d), and intensive care unit length of stay (mean, 1.6 d) (Tables 3 and 4).

TABLE 3 Baseline Lesion Characteristics

Type of aneurysm	Juxtarenal abdominal aortic aneurysm	
Maximum aneurysm diameter (mm) N	205	
 Mean (SD)	67.5 (13.3)	
 Range	49, 124	
Proximal neck length (mm) N	205	
 Mean (SD)	5.4 (3.7)	
 Range	2, 27	
Final proximal seal zone (mm) N	203	
 Mean (SD)	41.6 (11.6)	
 Range	18.9, 92.9	
Branch vessel involvement, N (%)	203	
 Right renal	15 (7.4)	
 Left renal	20 (9.9)	
 Right and left renal	169 (83.2)	
 Superior mesenteric	22 (10.8)	
 Celiac	2 (1.0)	

TABLE 4 Procedural Details and Length of Stay (For All Devices)

Device modification time (min) N	203	
 Mean (SD)	48.7 (11.2)	
 Range	16, 78	
Length of anesthesia (min) N	203	
 Mean (SD)	198.2 (59.8)	
 Range	90, 488	
Length of surgical procedure (min) N	203	
 Mean (SD)	137.7 (52.6)	
 Range	56, 427	
Fluoroscopy time (min) N	203	
 Mean (SD)	33.8 (17.5)	
 Range	8.9, 164	
Volume of contrast (mL) N	203	
 Mean (SD)	93.0 (32.9)	
 Range	15, 214	
Estimated blood loss (mL) N	203	
 Mean (SD)	118.8 (141.2)	
 Range	20, 1000	
Length of ICU stay (d) N	203	
 Mean (SD)	1.6 (1.6)	
 Range	0.5, 15.9	
Total length of hospital stay (d) N	203	
 Mean (SD)	3.7 (6.9)	
 Range	1, 87.3	
ICU indicates intensive care unit.

Five distinct commercially available EVAR devices were used during the study period. Technical success differed between the 5 different commercially available devices. Technical Success and Graft Modification Times for Terumo TREO (N=110), COOK Zenith (N=75), Medtronic Endurant (N=14), Bolton Relay (N=3), and COOK ZFEN (N=1) were 95.5%/43.4 minutes, 92.3%/54.8 minutes, 92.9%/54.1 minutes, 66.7%/66.0 minutes, and 100%/37 minutes, respectively.

There were 575 fenestrations made for 387 renal arteries, 181 superior mesenteric arteries (SMAs), and 7 celiac arteries. One hundred sixty-nine (83.2%) patients had bilateral renal arteries stented, 35 (17.2%) had only 1 renal artery stented, and 22 (10.8%) patients had stenting of the SMA: 1 patient had an SMA stent placed before the procedure, 19 had the SMA stented during the procedure, and 2 stented after the procedure. Renal arteries were stented in 96% of patients. There were a total of 410 stents implanted into the renal arteries of 203 patients. The average renal stent diameter and length was 6.6×22.1 mm. The average SMA stent diameter and length was 7.4×22.8 mm. To date, there were no open conversions or device migrations and one late partial explant for distal graft thrombosis. One patient had a presumed graft infection. A total of 3 ruptures (1.4%) were recorded on days 830, 1346, and 1460. The etiology for these ruptures was a type 3 endoleak in 2 cases and a type 2 endoleak with sac expansion in the third case. Thirty-day all-cause mortality was 2.9% (6/204). There was 1 type Ia, 1 type Ib, and 7 type III endoleaks during follow-up treated with successful reintervention at the 1 year period. There were 6 type 3c endoleaks, all involving renal stent separations, and 1 type 3a endoleak with limb component separation. The most common reason for early secondary intervention within 30 days and 6 months of the index procedure included 6 femoral artery pseudoaneurysms, 2 SMA stents placed within 24 hours of the index procedure, and, due to extended fluoroscopy time, there were 2 additional renal stents placed during the same index hospitalization. The overall rate of major adverse events at 30 days was 14.6% (29/198). Technical success was 93.7%, and overall treatment success was 82.6%.

Freedom from all-cause mortality was 69% at 5 years and is listed in Figure 2, and freedom from aneurysm-related mortality was 93% at 5 years and is listed in Figure 3. Freedom from reintervention was 84% at 1 year and 60% at 5 years.

FIGURE 2 Kaplan–Meier survival curve; freedom from all-cause mortality.

FIGURE 3 Kaplan–Meier survival curve; freedom from aortic-related mortality.

DISCUSSION

This manuscript reports the long-term results for PMEGs in the longest-standing investigational device exemption clinical trial with the FDA in the United States. Our institution coined the term “PMEG” in April of 2007 to describe an endoluminal graft that was modified or customized to fit patient-specific anatomy. Since then, there have been numerous publications from other institutions utilizing different techniques to modify endoluminal grafts. The safety and effectiveness of these techniques have been validated by numerous authors.3–5,7–14 Sanders and colleagues found better results when PMEG was performed as the index procedure to repair a juxtarenal abdominal aortic aneurysm as opposed to the indication of a previously failed EVAR. Freedom from reintervention was significantly higher for index PMEG than secondary PMEG, specifically 82% versus 38% at 3 years (P<0.001).8 The take-home message from this series was that, when feasible, PMEG should be preferred over substandard EVAR performed at the index operation. Other authors have noted the advantage of PMEG in the nonelective clinical setting, specifically in the case of symptomatic or ruptured juxtarenal aortic aneurysms.3,9

PMEG has been evaluated in direct comparisons with open surgical repair as well as less-conventional endovascular approaches to include chimneys and snorkels and has been found to be as good or even better than those alternatives. Rastogi and colleagues looked at a comparison of 1961 patients undergoing FEVAR (18% PMEG) compared with 3385 undergoing complex open aortic repair in the Vascular Quality Initiative over a 7-year period stratified by age. The main lessons learned were that FEVAR/PMEG was associated with lower perioperative mortality compared with open repair in patients over 65 years of age, but there were similar outcomes in those under 65 years of age. At 5 years, the outcomes were similar in all age groups.15 O’Donnell and colleagues performed a large study of complex endovascular repair of juxtarenal aortic aneurysms and found that snorkels and chimneys were associated with higher perioperative morbidity than FEVAR/PMEG. Rates of perioperative death in this study were low for PMEG (2.7%, n=256).16 Each of the patients that had failure to implant the device in our series had 3 defining characteristics: severe morbid obesity, severe iliac tortuosity, and significant aortic angulation. We believe these 3 characteristics when combined, lead to significant technical challenges.

Questions have arisen over the long-term durability of these grafts compared with company-manufactured devices (CMDs). In 2020, our institution published the first report of long-term durability of a PMEG when a prior study subject died at age 89 in a car crash 7 years after the initial implantation of his PMEG to treat and 7.9 cm juxtarenal aortic aneurysm. He donated his aortic remains to the University of Washington for postmortem analysis.17 This analysis demonstrated the graft to be exactly the same as the day of surgery, 7 years after implantation, with an excellent clinical outcome and sac regression to 5.0 cm. Dossabhoy et al18 performed a head to head comparison of PMEG with CMDs and found the outcomes of each procedure to be identical in terms of graft durability. In our experience, over half of the patients referred with juxtarenal aortic aneurysms were not candidates for commercially available devices due to company restrictions regarding the placement of the fenestrations. The most common reason for this was the right renal artery being too close to the SMA fenestration. Until these limitations can be corrected with company manusfactured devices, PMEG will continue to play an important role in these patients. The reader must recall that these patients met strict inclusion/exclusion criteria and had to have an infrarenal neck of at least 2 mm with a parallel aortic wall in the visceral aortic segment. None of the patients in this study had para-renal or thoracoabdominal aneurysms.

The Achilles heel of any endovascular strategy to treat aortic aneurysmal disease using endovascular methods revolves around the need for subsequent secondary interventions. Our group and others have found that specific anatomic factors such as iliac tortuosity, but not aortic angulation are associated with increased rates of reinterventions and type 1 and 3 endoleaks.19 We have also found that reintervention after PMEG is not necessarily considered to be a failure of the index procedure.20 In our analysis, reinterventions after PMEG were most commonly percutaneous, minor, and low-magnitude procedures and nondetrimental to long-term survival. Interestingly, however, early reinterventions were associated with increased mortality.

Future trends involving PMEGs are exciting and include the use of standardized operative techniques and artificial intelligence to improve operative efficiencies and improve outcomes. Our group has validated the use of automated software for precise preoperative planning and the creation of 3-dimensional printed aortic templates that could be rapidly created and used at the time of surgery for the accurate placement of fenestrations, potentially eliminating the chance for human error.6 Our group was the first to have initial clinical experience using the Terumo Aortic “TREO” endograft (Sunrise, FL) as a PMEG in 2016.7 In our opinion, this graft has the most flexibility and ease of use for creating fenestrations over a wide range of “real estate” on the graft with wide amplitude stents spaced far apart on the main body of the graft. Jayet et al have performed bench testing of radial force and elastic recoil for different types of graft fenestrations and concluded that PMEG fenestrations could be improved with standardization of fenestration creation protocols. Easier methods of graft reloading and newer fenestration rings and sutures are currently being developed to help facilitate the standardization of the PMEG technique.

Financial considerations surrounding PMEG are noteworthy, especially for those physicians at the beginning of their learning curve in performing these techniques. Clearly, rapid procedure times for these patients correlate with better outcomes. We have found that FEVAR and PMEG procedures can be performed at a high-volume medical center with positive contribution margins and that direct hospital costs decrease with increased operator experience.21

There are several distinct advantages to using a bifurcated endograft during a fenestrated repair of a juxtarenal abdominal aortic aneurysm. After stenting the visceral vessels, wire access has been maintained to the limbs of the endograft the entire time, thereby requiring only the implantation of 2 remaining limbs thus shortening the procedure and avoiding the insertion of large sheaths that can damage the previously placed visceral stents. Also, by maintaining 2 points of fixation with a contralateral large sheath, the graft can be rotated and collapsed to allow for the repositioning of the endograft and the elimination of diameter reduction as with other commercially available grafts.

Our study does have limitations as these results represent the findings of the first long-standing IDE at a single institution with a single surgeon and may not be generalizable across other centers. Expertise was obtained in an iterative fashion with several different grafts utilized. We have previously published our results on the learning curve for FEVAR and demonstrated the significant improvement that occurs with experience.21 In addition, not every patient with a juxtarenal aneurysm can be enrolled in this IDE due to anatomic restraints as well as the ability to meet the rigid follow-up criteria.

ACKNOWLEDGMENTS

The authors thank Billi Tatum RN and Brenda Kline ARNP for supporting the PSIDE for Physician Modified Endografting from 2011 to 2024 and providing safe and effective care for those subjects under their surveillance. The authors also thank Nate Ashford for the help in formatting the figures in the manuscript and Tomiko Mihara for diligence in updating the data set.

CONCLUSIONS

These long-term results are excellent and verify our early and mid-term reports that endovascular repair with PMEG is safe and effective for managing patients with juxtarenal aortic aneurysms. PMEG has exceptional long-term rates of morbidity, mortality, and endoleak. 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 timely and reliable off-the-shelf solutions are not currently available.

DISCUSSANT

Dr. Jeffrey Drebin (New York, NY)

This paper will be discussed by Dr. Mitchell.

Dr. Erica Leith Mitchell (Memphis, TN)

Dr. Starnes and the University of Washington vascular surgical team, congratulations on this important work. Physician-modified endovascular grafts represent a breakthrough in the management of urgent and emergent complex aortic pathologies. Your innovative work consolidates PMEG as a safe, versatile, and effective long-term treatment solution for elective symptomatic and ruptured juxtarenal aortic aneurysms. PMEGs have now been adopted widely, and recent data suggest that PMEGs, back table and in vivo, account for almost 20% of complex aortic aneurysms treated in the United States.

PMEGs, however, are not the perfect solution for the management of complex aortic aneurysms, and current PMEG solutions have compromises. Back-table bespoke PMEGs require significant expertise, extensive preoperative planning, advanced 3D central line imaging, and potentially lengthy times from the start of graft modification to graft deployment. Likewise, in situ laser fenestration, an alternative version of physician-modified grafts, risks potential graft fatigue, type 3 endoleaks, and target organ ischemia. Your PMEG program, with its superlative outcomes, is not replicable in other institutions.

Limitations to the broad application of PMEGs include expertise and regulatory approval. These factors make standardization and quality control unsolved dilemmas. Standardizing this technique for PMEG, even with a 3D printer, is challenging. Each step of the graft modifications and deployment requires precision. Regarding quality control, in the United States, it is “strongly encouraged that PMEGs be performed under the aegis of an IDE from the FDA,” and patients receiving this therapy ought to be enrolled in clinical studies.

I pose the following questions:To what extent are your trainees and partners involved in the PMEG process of PMEG creation? Please speak to standardization and the learning curve, ie, absolute minimum threshold for learning.

With your demonstrated safety and efficacy of the technique, do you think FDA oversight is necessary, and what are your thoughts about PMEG utilization outside of the IDE, because it’s clearly occurring in the United States?

Response from Benjamin Starnes

Thank you, Dr. Mitchell, for those comments. To answer your first question about trainees and their involvement in these procedures, we involve our trainees in every single one of these cases. They help plan the cases. They participated in the cases, and this stimulated the whole 3D printed template question about 10 years ago. I had a senior fellow who sized a case. I had done this case, and I thought it was a perfectly sized case, so I asked my senior fellow to size it. Then, I asked my senior resident to size it. They both had 2 dramatically different plans, and I trained them to size these cases, and so I said, “Something’s wrong here. There’s too much human variability,” and so that’s when we got into the 3D printed templates and using artificial intelligence to take that human variability off the table and make it a more standardized process. We wrote a paper using these data years ago and calculated the learning curve to be about 30 cases.

The second question was about FDA oversight. The FDA is extremely excited about bringing PMEG out of the shadows and into the mainstream. They realize that it’s going on outside of IDE clinical trials, and so the fact that we now have standardized suturing techniques, standardized fenestration rings, standardized reloading tools, it makes it a safer procedure. To include the artificial intelligence-generated 3D templates, I think that they’re excited that this will move forward outside of IDEs.

Thank you.

Dr. Jeffrey Drebin (New York, NY)

The next question is from Dr. Kashyap.

Dr. Vikram Kashyap (Grand Rapids, MI)

Thanks very much, Dr. Starnes, and congratulations. You and your team have been trailblazers in this area with such a great experience.

Two questions. One, your title indicates that you treated ruptured aneurysms. Can you tell us a little bit about the outcomes in those patients? These cases take time, and I imagine in ruptured patients, that’s a challenge.

The second question, similar to Dr. Mitchell’s question, is really the broad applicability of this technology, and can you give the audience a sense of, you know, 5 years from now, PMEG versus off-the-shelf options versus industry-planned devices that are available?

Thank you.

Response from Benjamin Starnes

Thank you, Dr. Kashyap. Your first question was about ruptures. We treated 5 patients with ruptured aneurysms and 13 with symptomatic aneurysms. Most of the time at Harborview, we have the patient’s imaging before they even arrive at the hospital, and so we’re able to actually size the patient and begin to create the graft before the patient even arrives if they’re a patient that’s a candidate. All of those cases were successful. Two of the 5 patients were stable, but I think if you have the ability to get the patient in the room, get an aortic occlusion balloon up, and have your team working on that while you’re creating the device, that’s a very powerful thing. It used to be that if we had a discrepant renal, we would just go up and cover the one renal and commit that kidney to death to achieve a successful result in a patient who was alive. Now doing a single fenestration is probably the easiest PMEG you’ll do and takes about 15 minutes to create the graft.

Your second question was about the broad applicability of PMEG. You know, we’re surgeons. When I do an open thoracoabdominal aortic aneurysm repair, I take a graft off the shelf. I fashion it to fit the patient’s anatomy. I may take a bypass graft off to a renal or to the SMA, and that’s the art of surgery. We are relying on industry to provide devices to us that is a one-size-fits-all device, and I don’t think that that’s the art of surgery. We need to personalize these devices to fit the patient.

Thank you.

Dr. Daniel Margulies (Los Angeles, CA)

Dan Margulies, Los Angeles. Fantastic work. Thank you for sharing. My question is regarding trauma patients, although these patients are generally elderly, they can be more frequently involved with falls in those that have a graft, and I wondered if you had a word of caution because tranexamic acid is part of the routine now for these patients with a head injury, and it’s just I know maybe anecdotal but concerning that someone after a hip repair died of a thrombosed graft. Should we be worried enough not to use it in patients who have an endograft that do fall and have the normal protocol of head injury Tranexamic Acid?

Response from Benjamin Starnes

No, I think you need to continue to do your standard protocols. This was just something when we went back and adjudicated all the information revolving around this case, this guy was 2 years out and had had a successful result based on his CT scan. His sac was regressing in size, and we went back, and I said, “I wonder if he had Tranexamic Acid during his hip replacement?” and sure enough, he did, and he woke up from that procedure with an aortic occlusion, so I don’t know if this is just an anecdotal experience. I don’t know if the patient was hypotensive during the procedure, but I think it’s a signal that we may need to look into this further. And by the way, he survived his graft thrombosis and explant.

Dr. Daniel Margulies (Los Angeles, CA)

Thank you.

Dr. Jeffrey Drebin (New York, NY)

Dr. Timaran?

Dr. Carlos H. Timaran (Dallas, TX)

Thank you. Ben, congratulations. This is awesome, especially because you have shown us that you started one way, but you had to improve, and constantly, you know, re-examining the way you do things is the way to improve.

Now we started a program in Dallas in the same way as you did, but actually outside the IDE, but when we weren’t able to get an IDE, we went the opposite way. We went with company-manufactured devices, and the reason is more quality control. Those devices are now shipped to us within 4 weeks, 6 weeks, and we realized that even when we have 1 device available, the ZFEN is not as good, so what’s the role of the PMEGs in the setting of company-made devices that are becoming more available? I agree with you, that patient-specific devices are the way to go, and I don’t agree with you that the FDA wants us to do more PMEGs necessarily because, look, they rushed the approval of a device now that will be available even for juxtarenal, which I don’t think is the right thing because there are some outcomes that are not that great, so that’s the question for you, what’s the role of PMEGs in the setting of having availability of company-made devices, number 1, and number 2, what is going to happen with these new devices that I don’t think are necessarily the best, even though they are company-made?

Thanks.

Response from Benjamin Starnes

Thank you, Dr. Timaran. As far as the company-manufactured devices, they’re only available to certain centers throughout the country, and our experience has been not 4 weeks but 6 to 8 weeks to obtain the device. Telling a patient that they have to wait 6 to 8 weeks to have their 9 cm juxtarenal aneurysm repaired, I’ve had 3 patients die waiting to undergo fenestrated EVAR that were outside of our IDE, and, you know, having those discussions with the patients’ families can be quite difficult.

I think that again, earlier I stated that the company-manufactured devices, we’re relying too much on industry to provide us with the tools that we need when we know that, as surgeons, we can create the graft that we need and personalize it to the patient.

Thank you.

Dr. Jeffrey Drebin (New York, NY)

This will be the last question.

Dr. William Darrin Clouse (Charlottesville, VA)

I also rise to congratulate you and recognize you for your foundational work in this area. I guess my question has to do with the physician-modified process. Can you speak a little bit about the learning curve? You’ve mentioned that you’ve standardized the creation of the fenestrations. How have you done that, and what have you learned in that process?

Response from Benjamin Starnes

Thank you, Dr. Clouse. Yes, so we have pretty much sized the graft to fit the patient. The standardized process basically takes us now about 35 to 40 minutes to create the graft. When we unsheathe the device and have marked off our fenestrations, as soon as we cut for the fenestrations, we call for the patient because we know that by the time they get the patient back in the room and off to sleep, put the A-line in, we’re done making the graft, so then we begin the procedure. The procedures now take about an hour and 15 minutes. Once we select the renal arteries, I ask the fellows this question, “What’s the next step?” and she or he says, “Call for the next patient because this case is done,” and that’s how streamlined these cases can be, and I encourage you or anyone to come and watch us do these cases at Harborview because the process is very, very efficient.

Thank you.

Dr. Jeffrey Drebin (New York, NY)

Thank you very much.

Response from Benjamin Starnes

Thank you.

B.W.S.: Terumo Aortic (consulting). The remaining authors report no conflicts of interest.
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