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1.
J Vasc Surg Cases Innov Tech ; 10(6): 101616, 2024 Dec.
Article in English | MEDLINE | ID: mdl-39351205

ABSTRACT

For high-risk patients with complex aortic aneurysms and post-dissection aneurysms, fenestrated and branched endovascular aortic repair (F/BEVAR) offers minimally invasive options customized to each individual's anatomy. Company-manufactured devices or physician-modified endovascular grafts performed under the purview of an investigational device exemption are two United States Food and Drug Administration-approved avenues to perform fenestrated and branched endovascular aortic repair. This case report describes a creative use of physician-modified endograft to salvage renal function in a solitary kidney with a near immediate bifurcation of the renal artery in a patient with post-dissection extent II thoracoabdominal aortic aneurysm. In our patient, the immediate bifurcation (2 mm distal to the common left renal artery orifice) of the left renal artery in the setting of a known long-standing occlusion of a remotely placed right renal stent presented a clinical and technical challenge to maintaining this patient's kidney function without sacrificing a significant portion of his remaining solitary kidney. Additionally, each branch was sizeable (5 and 7 mm), perfusing the cranial and caudal half of the kidney, respectively. Early bifurcation of renal arteries often results in sacrifice of the smaller branch to obtain adequate target vessel seal. Although some analyses have shown no change in glomerular filtration rate from coverage of accessory renal arteries, more recent studies have indicated clinically significant drops in both glomerular filtration rate and kidney length at 2-year follow-up. Herein, we describe use of a combination of an inner and external branch modification to stent both branches to preserve renal parenchyma and function. The patient has provided written informed consent for publication of this case report and their associated imaging studies.

2.
J Endovasc Ther ; : 15266028241283241, 2024 Sep 28.
Article in English | MEDLINE | ID: mdl-39340443

ABSTRACT

BACKGROUND: We sought to describe our experience and outcomes of a zone 0 landing physician-modified aortic stent for the treatment of aortic arch pathologies late after open ascending aortic replacement. METHODS: This study included consecutive patients with aortic arch diseases treated with total endovascular repair using different techniques. The indication for endovascular repair was agreed on in a multidisciplinary discussion. Study end points were technical success, early and late outcomes. RESULTS: From November 2018 to May 2022, 16 consecutive patients underwent total endovascular repair of aortic arch pathologies. Median time for surgery was 4.8 hours (range, 2.6-6.6 hours). All the new-onset aortic arch pathologies were successfully treated. The 30-day mortality rate was 0%. Two patients had endoleak. The median length of postoperative stay was 4 days (range, 3-6 days). During follow-up, 1 patient underwent reintervention for type II endoleak. There were no conversions to retrograde dissection, aortic rupture and stroke. CONCLUSIONS: Our experience of using different total endovascular techniques for selective patients with arch pathologies who may be unfit or too risky for reopen surgery revealed favorable initial results. In addition, these techniques are promising options for urgent arch pathologies without availability of custom-manufactured devices. Durability concerns will need to be assessed in additional studies with long-term follow-up. CLINICAL IMPACT: The use of physician-modified and in situ fenestrated stent grafts in zone 0 landing for aortic arch pathologies in patients with prior open ascending aortic replacement is effective in endovascular therapy. This innovation enables clinicians to offer an alternative option to high-risk patients, potentially reducing morbidity and mortality. It underscores the feasibility of tailored endovascular therapy in complex aortic diseases, where customized devices may not be available.

3.
Vasc Endovascular Surg ; 58(8): 876-883, 2024 Nov.
Article in English | MEDLINE | ID: mdl-39163873

ABSTRACT

BACKGROUND: Endovascular repair of thoracic aortic aneurysms (TAA) in elective settings has demonstrated successful clinical outcomes. However, life-threatening conditions such as rupture are more often managed with open surgical repair due to the high complexity of arch endovascular repair, lack of available off-the-shelf devices, and limited long-term data. CASE SUMMARY: A 49-year-old female with a recent history of prior ascending aortic repair for Type A10 aortic dissection presented with chest pain and dyspnea. Chest computed tomography angiogram (CTA) revealed acute bilateral pulmonary emboli and a 6.2 cm post dissection aneurysm of the posterior aortic arch with the dissection extending to the right iliac artery. She was treated with thrombolysis and subsequently became hemodynamically unstable. Repeat CTA revealed a massive left hemithorax with concern for aortic arch rupture. Given significant cardiorespiratory compromise and recent open repair, she was considered unfit for redo open repair. Thoracic endovascular aortic repair (TEVAR) with a physician-modified endograft (PMEG) was planned. An Alpha Zenith endograft was modified adding an internal branch for the innominate artery and a fenestration for the left common carotid artery. The left subclavian artery was occluded with a microvascular plug and coil embolization up to the level of the vertebral artery. TEVAR PMEG extension to the celiac artery was performed followed by deployment of a Zenith dissection stent to the aortic bifurcation. Completion angiogram demonstrated successful aneurysm exclusion and patency of target vessels. CONCLUSION: Endovascular treatment of ruptured TAA with PMEGs is feasible. This approach may be an alternative for unfit patients for open repair in emergent settings.


Subject(s)
Aortic Aneurysm, Thoracic , Aortic Dissection , Aortic Rupture , Blood Vessel Prosthesis Implantation , Blood Vessel Prosthesis , Endovascular Procedures , Prosthesis Design , Stents , Humans , Aortic Dissection/surgery , Aortic Dissection/diagnostic imaging , Aortic Dissection/physiopathology , Female , Middle Aged , Aortic Aneurysm, Thoracic/surgery , Aortic Aneurysm, Thoracic/diagnostic imaging , Aortic Aneurysm, Thoracic/physiopathology , Endovascular Procedures/instrumentation , Blood Vessel Prosthesis Implantation/instrumentation , Treatment Outcome , Aortic Rupture/diagnostic imaging , Aortic Rupture/surgery , Aortic Rupture/physiopathology , Aortography , Aneurysm, Aortic Arch
4.
J Endovasc Ther ; : 15266028241266158, 2024 Jul 26.
Article in English | MEDLINE | ID: mdl-39058232

ABSTRACT

PURPOSE: To describe the X-over reversed iliac extension technique in a patient with severe peripheral arterial disease (PAD) scheduled for inner branched endovascular aortic repair (iBEVAR). TECHNIQUE: A multimorbid 62-year-old male patient was planned for iBEVAR due to a 58 mm suprarenal aortic aneurysm. The patient had a previous right femoropopliteal bypass and stenting of the left iliac axis. At admission, he presented with recent onset severe left limb claudication, which was attributed to left iliac stent occlusion. To avoid the postoperative compression of the right common femoral artery (CFA) and preserve the patency of the bypass, a single left CFA access, followed by left iliac artery recanalization, was decided. The right iliac axis was catheterized with a Lunderquist wire using X-over access from the left CFA. An iliac extension (ZISL, 24-59, Cook Medical, Bloomington, USA) was reversed and resheathed on back-table and implanted in the right common iliac artery using the X-over technique. The left CFA access was used to complete the remaining steps of the procedure. The predischarge computed tomography angiography confirmed bilateral iliac artery and femoropopliteal bypass patency. CONCLUSION: The X-over reversed iliac extension technique may be applied in selected PAD patients, when undergoing complex endovascular aortic repair. CLINICAL IMPACT: As the number of patients with peripheral arterial disease (PAD) is expected to increase the upcoming decades, out of the box solutions may be needed to assist complex endovascular aortic management. The X over technique, which consist of the contralateral advancement of an on-table reversed iliac limb, was successfully applied in a patient with severe PAD and numerous previous peripheral interventions, who was managed with branched endovascular aortic repair . The X Over technique may provide an additional alternative in well-selected patients with demanding vascular access undergoing complex endovascular aortic procedures.

5.
Circulation ; 2024 Jul 11.
Article in English | MEDLINE | ID: mdl-38989565

ABSTRACT

BACKGROUND: Physician modified endografts (PMEGs) have been widely used in the treatment of complex abdominal aortic aneurysm and thoracoabdominal aortic aneurysm, however, previous data are limited to small single center studies and robust data on safety and effectiveness of PMEGs are lacking. We aimed to perform an international multicenter study analyzing the outcomes of PMEGs in complex abdominal aortic aneurysms and thoracoabdominal aortic aneurysms. METHODS: An international multicenter single-arm cohort study was performed analyzing the outcomes of PMEGs in the treatment of elective, symptomatic, and ruptured complex abdominal aortic aneurysms and thoracoabdominal aortic aneurysms. Variables and outcomes were defined according to the Society for Vascular Surgery reporting standards. Device modification and procedure details were collected and analyzed. Efficacy outcomes included technical success and safety outcomes included major adverse events and 30-day mortality. Follow-up outcomes included reinterventions, endoleaks, target vessel patency rates and overall and aortic-related mortality. Multivariable analysis was performed aiming at identifying predictors of technical success, 30-day mortality, and major adverse events. RESULTS: Overall, 1274 patients were included in the study from 19 centers. Median age was 74 (IQR, 68-79), and 75.7% were men; 45.7% were complex abdominal aortic aneurysms, and 54.3% were thoracoabdominal aortic aneurysms; 65.5% patients presented electively, 24.6% were symptomatic, and 9.9% were ruptured. Most patients (83.1%) were submitted to a fenestrated repair, 3.6% to branched repair, and 13.4% to a combined fenestrated and branched repair. Most patients (85.8%) had ≥3 target vessels included. The overall technical success was 94% (94% in elective, 93.4% in symptomatic, and 95.1% in ruptured cases). Thirty-day mortality was 5.8% (4.1% in elective, 7.6% in symptomatic, and 12.7% in ruptured aneurysms). Major adverse events occurred in 25.2% of cases (23.1% in elective, 27.8% in symptomatic, and 30.3% in ruptured aneurysms). Median follow-up was 21 months (5.6-50.6). Freedom from reintervention was 73.8%, 61.8%, and 51.4% at 1, 3, and 5 years; primary target vessel patency was 96.9%, 93.6%, and 90.3%. Overall survival and freedom from aortic-related mortality was 82.4%/92.9%, 69.9%/91.6%, and 55.0%/89.1% at 1, 3, and 5 years. CONCLUSIONS: PMEGs were a safe and effective treatment option for elective, symptomatic, and ruptured complex aortic aneurysms. Long-term data and future prospective studies are needed for more robust and detailed analysis.

6.
J Pers Med ; 14(7)2024 Jul 17.
Article in English | MEDLINE | ID: mdl-39064014

ABSTRACT

Standard endovascular aortic repair (EVAR) has become the standard of care for treating infrarenal abdominal aortic aneurysms (AAAs) in patients with favorable anatomies, while patients with challenging AAA anatomies, and those with suprarenal or thoraco-abdominal aneurysms, still need alternative, more complex, solutions, including custom-made branched or fenestrated grafts, which are constrained by production delay and costs. To address urgent needs and complex cases, physicians have proposed modifying standard endografts by manually creating graft fenestrations. This allows for effective aneurysm exclusion and satisfactory patency of visceral vessels. Although physician-modified grafts (PMEGs) have demonstrated high technical success, standardized creation processes and long-term safety data are still lacking, necessitating further study to validate their clinical and legal standing. The aim of this article is to illustrate the state of the art with regard to this surgical technique, summarizing its origin, evolution, and the main clinical evidence supporting its effectiveness. The paper also aims to discuss the main medico-legal issues related to the use of PMEGs, with particular reference to the issue of safety related to the standardization of the surgical technique, medical liability profiles, and informed consent.

7.
J Cardiovasc Dev Dis ; 11(5)2024 Apr 25.
Article in English | MEDLINE | ID: mdl-38786956

ABSTRACT

BACKGROUND: We conducted an in vitro comparison of the snare loop reinforcement against a closed-loop reinforcement (Hungaroring) for physician-modified endograft (PMEG) fenestrations regarding preparation time and stability during flaring balloon dilatation. MATERIALS AND METHODS: The time to complete a PMEG fenestration with reinforcement was measured and compared between the Hungaroring and snare loop groups. The number of stitches was counted. Each fenestration was dilated using a 10 mm high-pressure, non-compliant balloon up to 21 atm in pressure, and fluoroscopic images were taken. The presence of indentation on the oversized balloon at the level of the reinforcement was evaluated at each fenestration. RESULTS: Five fenestrations were created in each group (n = 5) for a total of ten pieces. The completion time in the snare loop group was 1070 s (IQR:1010-1090) compared to 760 s (IQR:685-784) in the Hungaroring group (p = 0.008). Faster completion time was achieved by faster stitching (23.2 s/stitch (IQR 22.8-27.3) for the snare loop group and 17.3 s/stitch (IQR 17.3-20.1) for the Hungaroring group (p = 0.016). None of the fluoroscopic images of the snare loop reinforcement showed an indentation on the balloon during the overexpansion; on the contrary, the Hungaroring showed indentation in every case, even at 21 atm. CONCLUSION: Fenestrations reinforced with Hungaroring can be completed significantly faster. Furthermore, the Hungaroring resists over-dilation even at high pressures, while snare loop reinforcements dilate at nominal pressure.

8.
J Vasc Surg Cases Innov Tech ; 10(3): 101491, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38699664

ABSTRACT

We describe the feasibility and safety of a standardized approach for four-fenestrated physician-modified endograft (PMEG) placement to treat complex abdominal aortic aneurysms using the Valiant Captivia platform (Medtronic). The standardization is based on specific selection criteria for anatomical feasibility, measurement method, and modification technique of a single endograft type. Six cases (two juxtarenal, two pararenal, and two type IV thoracoabdominal aneurysms) were treated, with 24 target vessels incorporated with fenestrations. Four cases were treated in an urgent setting and two were elective. The time modification required was 121 ± 18 minutes. Technical success was 100%, with no mortality or complications at 30 days. Postoperative computed tomography at 3 months demonstrated complete aneurysm exclusion, without a type I or III endoleak, no main graft- or fenestration-related loss of integrity, and no target vessel misalignment or stent fracture. The present standardized approach seems safe and feasible and might represent an initial benchmark for comparison with future studies.

9.
J Endovasc Ther ; : 15266028241249571, 2024 May 09.
Article in English | MEDLINE | ID: mdl-38721860

ABSTRACT

PURPOSE: This study aims to explore the feasibility and effectiveness of a unilateral transfemoral access endovascular salvage technique for complex abdominal aortic aneurysms with concurrent type Ia and Ib endoleaks following previous endovascular repair. CASE REPORT: A 69-year-old female with multiple comorbidities presented with an extent IV thoracoabdominal aortic aneurysm complicated by type Ia and Ib endoleaks and chronically occluded left iliac endoprosthesis after prior endovascular repair. Given the patient's medical complexities, open explant repair was deemed high risk. The case was successfully managed using a physician-modified fenestrated/branched endograft (PM-F/BEVAR) and an iliac branch device (IBD) deployed through a single percutaneous transfemoral access. CONCLUSION: The presented case demonstrates the safety and efficacy of PM-F/BEVAR with concomitant IBD deployment via unilateral transfemoral access. This innovative approach allows endovascular salvage in cases with restricted iliofemoral access and avoids the complexities associated with upper extremity or aortic arch manipulation. While acknowledging the technical challenges, this technique offers a viable alternative for salvaging failed endovascular repairs, emphasizing the importance of real-time modifications in achieving successful outcomes. Further studies and long-term follow-up are warranted to validate the broader applicability and durability of this approach in the management of complex abdominal aortic aneurysms with multiple endoleaks. CLINICAL IMPACT: Although not the conventional approach, unilateral transfemoral access can be utilized to implant either a physician-modified fenestrated aortic endograft or an iliac branch device. Such an approach avoids complicating issues related to upper extremity access. This innovative technique may be necessary when there is a failed prior EVAR in the setting of significant contralateral iliofemoral occlusive disease. Doing both procedures in the same setting to resolve a type Ia and Ib endoleak is feasible as demonstrated in this case report. Expanding the endovascular armamentarium to address EVAR failure will be increasingly useful in the future, especially given the morbidity profile of EVAR explantation.

10.
Eur J Vasc Endovasc Surg ; 68(2): 190-199, 2024 Aug.
Article in English | MEDLINE | ID: mdl-38641315

ABSTRACT

OBJECTIVE: This multicentre study aimed to assess the early and midterm outcomes of physician modified fenestrated endografts (PMEGs) for endovascular aortic arch repair in zone 0. METHODS: Between 2018 and 2022, a retrospective study was conducted in three centres of consecutive patients undergoing endovascular aortic arch repair in zone 0 with PMEGs. Endpoints included technical success, 30 day mortality rate, major adverse events, secondary interventions, stent stability, target vessel patency, and overall survival. RESULTS: A total of 54 patients (mean age 63 years; 45 males) with aortic arch pathology were included, comprising aortic dissections (n = 32; 59%) and aortic arch aneurysms (n = 22; 41%). Technical success was 98%. One patient died from stroke within 30 days. Major adverse events included stroke (n = 4; 7%), retrograde type A dissection (RTAD) (n = 3; 6%), and acute kidney injury (n = 2; 4%). During a median follow up of 12 months, there were two deaths (4%) of unknown cause at one month and 1.5 months, and no aortic related death. Type Ia, type Ic, and type IIIc endoleaks were observed in two (4%), three (6%), and two (4%) patients, respectively. No vessel stenosis was observed. Re-intervention was required in 10 patients (19%). Estimates of overall survival, freedom from secondary intervention, and freedom from target vessel instability at one year were 94.2% (standard error [SE] 3.3%), 81.8% (SE 6.0%), and 92.0% (SE 4.5%), respectively. CONCLUSION: This study has demonstrated the efficacy of PMEGs for zone 0 endovascular aortic arch repair, with acceptable technical success and mortality rates. Stroke, RTAD, and re-intervention rates remain a concern for endovascular therapy. A larger population and long term outcomes are required to assess the safety and durability of this technique as a beneficial choice for endovascular aortic arch repair in specialised centres.


Subject(s)
Aorta, Thoracic , Aortic Aneurysm, Thoracic , Aortic Dissection , Blood Vessel Prosthesis Implantation , Blood Vessel Prosthesis , Endovascular Procedures , Prosthesis Design , Stents , Humans , Male , Female , Middle Aged , Endovascular Procedures/instrumentation , Endovascular Procedures/adverse effects , Endovascular Procedures/methods , Endovascular Procedures/mortality , Retrospective Studies , Aorta, Thoracic/surgery , Aorta, Thoracic/diagnostic imaging , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/methods , Blood Vessel Prosthesis Implantation/mortality , Aged , Treatment Outcome , Aortic Aneurysm, Thoracic/surgery , Aortic Aneurysm, Thoracic/mortality , Aortic Aneurysm, Thoracic/diagnostic imaging , Aortic Dissection/surgery , Aortic Dissection/mortality , Aortic Dissection/diagnostic imaging , Postoperative Complications/etiology , Postoperative Complications/epidemiology , Time Factors
11.
Article in English | MEDLINE | ID: mdl-38490250

ABSTRACT

OBJECTIVES: Our goal was to evaluate early and mid-term outcomes of physician-modified endografting for pararenal and thoraco-abdominal aortic aneurysms from 10 Japanese aortic centres. METHODS: From January 2012 to March 2022, a total of 121 consecutive adult patients who underwent physician-modified endografting for pararenal and thoraco-abdominal aortic aneurysms were enrolled. We analysed early and mid-term postoperative outcomes, including postoperative complications and mortality. RESULTS: The pararenal and thoraco-abdominal aortic aneurysm groups included 62 (51.2%) and 59 (48.8%) patients, respectively. The overall in-hospital mortality rate was 5.8% (n = 7), with mortality rates of 3.2% (n = 2) and 8.5% (n = 5) in pararenal and thoraco-abdominal aortic aneurysm groups, respectively (P = 0.225). Type IIIc endoleaks occurred postoperatively in 18 patients (14.9%), with a significantly higher incidence (P = 0.033) in the thoraco-abdominal aortic aneurysm group (22.0%, n = 13) than in the other group (8.1%, n = 5). Major adverse events occurred in 7 (11.3%) and 14 (23.7%) patients in pararenal and thoraco-abdominal aortic aneurysm groups (P = 0.074), respectively. The mean follow-up period was 24.2 months. At the 3-year mark, both groups differed significantly in freedom from all-cause mortality (83.3% and 54.1%, P = 0.004), target aneurysm-related mortality (96.8% and 82.7%, P = 0.013) and any reintervention (89.3% and 65.6%, P = 0.002). Univariate and multivariate regression analyses demonstrated that ruptures, thoraco-abdominal aortic aneurysms and postoperative type IIIc endoleaks were associated with an increased risk of all-cause mortality. CONCLUSIONS: The mid-term outcomes of physician-modified endografting for pararenal and thoraco-abdominal aortic aneurysms were clinically acceptable and comparable with those in other recently published studies. Notably, pararenal and thoraco-abdominal aortic aneurysms represent distinct pathological entities with different postoperative outcomes.

13.
J Vasc Surg ; 79(6): 1276-1284, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38354829

ABSTRACT

INTRODUCTION: Custom-branched/fenestrated grafts are widely available in other countries, but in the United States, they are limited to a handful of centers, with the exception of a 3-vessel juxtarenal device (ZFEN). Consequently, many surgeons have turned to alternative strategies such as physician-modified endografts (PMEGs). We therefore sought to determine how widespread the use of these grafts is. METHODS: We studied all complex endovascular repairs of complex and thoracoabdominal aortic aneurysms in the Vascular Quality Initiative from 2014 to 2022 to examine temporal trends. RESULTS: A total of 5826 repairs were performed during the study period: 1895 ZFEN, 3241 PMEG, 595 parallel grafting, and 95 where parallel grafting was used in addition to ZFEN, with a mean of 2.7 ± 0.98 vessels incorporated. Over time, the number of PMEGs steadily increased, both overall and for juxtarenal aneurysms, whereas the number of ZFENs essentially leveled off by 2017 and has remained steady ever since. In the most recent complete year (2021), PMEGs outnumbered ZFENs by over 2:1 overall (567 to 256) and nearly twofold for juxtarenal repairs. In three-vessel cases involving juxtarenal aneurysms, PMEGs were used as frequently as ZFENs (43% vs 43%), whereas the proportion of juxtarenal aneurysms repaired using a four-vessel graft configuration increased from 20% in 2014 to 29% in 2021 (P < .001). The differences in PMEG use were more pronounced as surgeon volume increased. Surgeons in the lowest quartile of volume performed <2 complex repairs annually, evenly split between PMEGs and ZFENs. However, surgeons in the highest quartile of volume performed a median of 18 (interquartile range: 10-21) PMEGs/y, but only 1.6 (interquartile range: 0.8-3.4) ZFENs/y. The number of physician-sponsored investigational device exemption trials of PMEGs has expanded from 1 in 2012 to 8 currently enrolling. As those data are not included in the Vascular Quality Initiative, the true number of PMEGs is likely substantially higher. CONCLUSIONS: PMEGs have become the dominant endovascular repair modality of complex abdominal and thoracoabdominal aortic aneurysms outside of investigational device exemptions. The field of endovascular aortic surgery and patients with complex aneurysms would benefit from broader publication of PMEG techniques, outcomes, and comparisons to custom-manufactured grafts.


Subject(s)
Aortic Aneurysm, Thoracic , Blood Vessel Prosthesis Implantation , Blood Vessel Prosthesis , Endovascular Procedures , Prosthesis Design , Humans , Aortic Aneurysm, Thoracic/surgery , Blood Vessel Prosthesis/trends , Endovascular Procedures/trends , Endovascular Procedures/adverse effects , Endovascular Procedures/instrumentation , Blood Vessel Prosthesis Implantation/trends , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis Implantation/adverse effects , United States , Time Factors , Treatment Outcome , Practice Patterns, Physicians'/trends , Male , Retrospective Studies , Female , Aged , Databases, Factual , Registries , Aortic Aneurysm, Thoracoabdominal
14.
J Vasc Surg ; 79(3): 506-513.e1, 2024 Mar.
Article in English | MEDLINE | ID: mdl-37923022

ABSTRACT

INTRODUCTION: Frailty, a predictor of poor outcomes, has been widely studied as a screening tool in surgical decision-making. However, the impact of frailty on the outcomes after fenestrated-branched endovascular aortic repairs (FBEVARs) is less well established. In addition, the changes in frailty during recovery after FBEVAR are unknown. We aim to assess the impact of frailty on outcomes of high-risk patients undergoing physician-modified FBEVARs for complex abdominal and thoracoabdominal aortic aneurysms, as well as the changes in frailty during follow-up. METHODS: Consecutive patients enrolled in a single-center prospective Physician-Sponsored Investigational Device Exemption protocol (FDA# G200159) were evaluated. In addition to the baseline characteristics, frailty was assessed using the Hopkins Frailty Score (HFS) and frailty index (FI) measured by the Frailty Meter. Sarcopenia was measured by L3 total psoas muscle area (PMA). These measurements were repeated during follow-up. The follow-up HFS and FI were compared with baseline scores using the Wilcoxon signed-rank test, whereas follow-up PMA measurements were compared with the baseline using the paired t test. The association between baseline frailty and morbidity was evaluated by the Wilcoxon rank-sum test. RESULTS: Seventy patients were analyzed in a prospective Physician-Sponsored Investigational Device Exemption study from February 9, 2021, to June 2, 2023. At baseline, HFS identified 54% of patients as not frail, 43% as intermediately frail, and 3% as frail. Technical success of FBEVAR was 94% with one in-hospital mortality. Early major adverse events were seen in 10 (14.3%) patients. No difference in baseline FI was seen between patients with early morbidity and those without. Patients who were not frail per HFS were less likely to experience early morbidity (P = .033), and there was a significantly lower baseline PMA in patients who experienced early morbidity (P = .016). At 1 month, patients experienced a significant increase in HFS and HFS category (P = .001 and P = .01) and a significant decrease in sarcopenia (mean PMA: -96 mm2, P = .005). At 6 months, HFS and HFS category as well as PMA returned toward baseline (P = .42, P = .38, and mean PMA: +4 mm2, P = .6). CONCLUSIONS: Preoperative frailty and sarcopenia were associated with early morbidity after physician-modified FBEVAR. During follow-up, patients became more frail and sarcopenic by 1 month. Recovery from this initial decline was seen by 6 months, suggesting that frailty and sarcopenia are reversible processes rather than a unidirectional phenomenon of continued decline.


Subject(s)
Aortic Aneurysm, Abdominal , Aortic Aneurysm, Thoracic , Aortic Aneurysm, Thoracoabdominal , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Frailty , Sarcopenia , Humans , Blood Vessel Prosthesis , Aortic Aneurysm, Thoracic/diagnostic imaging , Aortic Aneurysm, Thoracic/surgery , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/surgery , Treatment Outcome , Frailty/complications , Frailty/diagnosis , Prospective Studies , Sarcopenia/complications , Sarcopenia/diagnostic imaging , Risk Factors , Postoperative Complications
15.
Vasc Endovascular Surg ; 58(2): 193-199, 2024 Feb.
Article in English | MEDLINE | ID: mdl-37473451

ABSTRACT

A 70-year-old male with a history of 3 prior median sternotomies and on anticoagulation presented with acute chest and back pain associated with a pseudoaneurysm of the ascending and aortic arch in the setting of residual dissection involving the innominate, proximal right carotid, and subclavian arteries. A physician-modified triple vessel fenestrated-branched arch endograft was deployed. The innominate branch stent was deployed from the right carotid cut down, while the left carotid and left subclavian branch stents were placed from a femoral approach. Postoperatively, the innominate branch was found to be deployed in the false lumen of the dissected native innominate artery, leading to continued pressurization of the pseudoaneurysm. This was rescued by placing a Gore Iliac Branch Endoprosthesis (IBE) into the innominate branch through a temporary conduit sewn to the right carotid artery with a right subclavian branch placed via a brachial artery cut down into the internal iliac gate. The use of IBE allowed branch stent extension past the dissected native vessels. The patient had an uneventful recovery without neurologic complications. At 3-month follow-up, the patient remains well with an excluded pseudoaneurysm, and patent bifurcated innominate, bilateral carotid, and subclavian artery branches. A Gore IBE can be utilized in a dissected innominate artery to create an innominate branch device during fenestrated-branched endovascular arch repair.


Subject(s)
Aneurysm, False , Aortic Aneurysm, Thoracic , Aortic Dissection , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Male , Humans , Aged , Aorta, Thoracic/diagnostic imaging , Aorta, Thoracic/surgery , Blood Vessel Prosthesis , Blood Vessel Prosthesis Implantation/adverse effects , Aneurysm, False/diagnostic imaging , Aneurysm, False/etiology , Aneurysm, False/surgery , Aortic Aneurysm, Thoracic/diagnostic imaging , Aortic Aneurysm, Thoracic/surgery , Aortic Dissection/diagnostic imaging , Aortic Dissection/surgery , Treatment Outcome , Prosthesis Design , Stents , Endovascular Procedures/adverse effects
16.
J Vasc Surg Cases Innov Tech ; 9(4): 101358, 2023 Dec.
Article in English | MEDLINE | ID: mdl-38106341

ABSTRACT

We present a case of a type Ia endoleak from an aortic endograft in close proximity to the renal arteries that was successfully treated with a back-table physician-modified endograft with inversion of the contralateral limb. This modification allowed for deployment of a fenestrated cuff and bifurcated distal main body over the flow divider of the previous endograft, thus avoiding the need for either an open aneurysm repair, physician-made fenestrations, or aorto-uni-iliac repair with femoral-femoral bypass. This case demonstrates that back-table physician-modified endograft contralateral limb inversion is an easy, reproducible, and effective technique.

17.
J Endovasc Ther ; : 15266028231212131, 2023 Nov 22.
Article in English | MEDLINE | ID: mdl-37990854

ABSTRACT

PURPOSE: To describe the endovascular treatment of a symptomatic juxtarenal abdominal aortic aneurysm (JAAA) using a combination of endoanchors (Heli-FX EndoAnchor, Medtronic, Minneapolis, Minnesota) and a physician-modified single-fenestrated endograft. TECHNIQUE: An 85 year-old patient unfit for open aortic repair presented for a symptomatic JAAA, characterized by an infrarenal neck with 0.6 cm in length and 23 mm in diameter. A 28 mm-diameter Endurant aortic cuff (Medtronic, Minneapolis, Minnesota) was modified with a single fenestration for the left renal artery (LRA) and diameter-reducing tie, then re-sheathed and deployed. The LRA was cannulated with a 7F sheath and the constraining wire was withdrawn. Being the shortest neck length on the right side of the cuff, the endograft was anchored to the aortic wall on this side with 2 endoanchors. The LRA was stented and flared, then a distal physician-modified (without free-flow) bifurcated Endurant graft (Medtronic, Minneapolis, Minnesota) was overlapped with the proximal cuff and stabilized with 6 endoanchors. Correct positioning with complete aneurysm exclusion was confirmed with a 30 day and 9 month computed tomography angiograms. CONCLUSIONS: In extremely selected cases, association of endoanchors and single-fenestrated physician-modified graft may be useful to treat complex urgent aortic aneurysm using readily available devices. CLINICAL IMPACT: This technical note demonstrates the feasibility of a single-fenestrated physician-modified Endurant endograft deployed in combination with endosuture fixation (FESAR), to urgently treat a juxtarenal aortic aneurysm unfit for open repair and not suitable for standard endovascular repair nor off-the-shelf endografts.

18.
J Endovasc Ther ; : 15266028231207023, 2023 Oct 30.
Article in English | MEDLINE | ID: mdl-37902431

ABSTRACT

OBJECTIVE: This study aimed to evaluate the outcomes of physician-modified endografts (PMEGs) for the treatment of thoracic aortic pathologies involving the aortic arch. METHODS: A retrospective single-center study was performed on consecutive patients with thoracic aortic pathologies treated by PMEGs between February 2018 and May 2022. Data on baseline characteristics, operative procedure, and follow-up information were collected. The endpoints included technical success, complications, mortality, overall survival, re-intervention, and target vessel instability. RESULTS: This study comprised 173 patients (mean age=58±13, range=28-83, 148 men) with thoracic aortic pathologies, including 44 thoracic aortic aneurysms, 113 aortic dissections (9 type A, 4 residual type A, 75 type B, 32 non-A non-B), 3 aortic intramural hematomas, and 13 penetrating aortic ulcers. Thirty-five of the patients had PMEGs with 3 fenestrations, 32 had 2 fenestrations, and 106 had 1 single fenestration. Technical success was 98% (170/173), and the 30-day mortality was 2% (3/173). Perioperative complications included stroke (n=3, 2%), retrograde type A dissection (RTAD; n=3, 2%) and renal injury (n=3, 2%). Seven deaths (4%) were noted during a median follow-up of 11 (range=1-52) months. Eleven cases of re-intervention were stent-related. There were 5 type Ia endoleaks (3%), 2 type III endoleaks (1%) from the innominate artery (IA), and 3 type Ic endoleaks (2%) from the left subclavian arteries. One case of IA stent-graft (SG) stenosis was noted because of mural thrombus. Estimate rates of overall survival, freedom from secondary intervention, and freedom from target vessel instability at 2 years were 93.4% (95% confidence interval [CI]=88.7%-98.1%), 80.7% (95% CI=73.3%-88.1%), and 89.0% (95% CI=80.4%-97.6%), respectively. CONCLUSIONS: Physician-modified endografts showed promising immediate therapeutic results in the treatment of thoracic aortic pathologies involving the aortic arch. Our study demonstrates that the technique is feasible and produces acceptable results. Long-term outcomes are required for further refinement of this technical approach to confirm technical success and durability over time as a valuable option for endovascular aortic arch repair in specialized centers. CLINICAL IMPACT: Our short- and mid-term outcomes of physician-modified endografts in 173 patients showed promising results compared to other branched/fenestrated techniques and backed up the endovascular repair of the aortic arch. Meanwhile, the technical expertise pointed out in our manuscript, including preloaded guidewire, diameter-reducing wire and inner mini-cuffs, provided reference and technical guidance for our peers. Most importantly, it demonstrated that the PMEG, as a device whose components were all commercially available, might be a better option for emergency surgery and for centers who had no access to custom-made devices.

19.
Orv Hetil ; 164(36): 1426-1431, 2023 Sep 10.
Article in Hungarian | MEDLINE | ID: mdl-37695716

ABSTRACT

Secondary rupture is a late complication of endovascular aneurysm repair (EVAR). Open surgery is a technically feasible treatment option in most cases, however, late conversion carries a significant risk of morbidity and mortality, as it usually requires at least partial explantation of the in situ device, which is of major concern especially if suprarenal fixation is present. Endovascular treatment of these cases is usually challenging, especially since the custom-made devices that are often needed are not readily available but having a production time of several weeks. To overcome this limitation, physician-modified stent grafts are getting accepted to treat such urgent cases. We present the case of a patient receiving EVAR who later experienced two ruptures, treated first with a physician-modified endograft and adjunctive endoanchoring, later with open ligation of the lumbar arteries. Orv Hetil. 2023; 164(36): 1426-1431.


Subject(s)
Aortic Aneurysm, Abdominal , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Physicians , Humans , Aortic Aneurysm, Abdominal/surgery , Stents
20.
J Vasc Surg ; 78(3): 565-574.e2, 2023 09.
Article in English | MEDLINE | ID: mdl-37187413

ABSTRACT

OBJECTIVE: Fenestrated-branched endovascular repair has become a favorable treatment strategy for patients with complex abdominal aortic aneurysms (cAAAs) and thoracoabdominal aortic aneurysms (TAAAs) who are high risk for open repair. Compared with degenerative aneurysms, post-dissection aneurysms can pose additional challenges for endovascular repair. Literature on physician-modified fenestrated-branched endovascular aortic repair (PM-FBEVAR) for post-dissection aortic aneurysms is sparse. Therefore, the aim of this study is to compare the clinical outcomes of patients who underwent PM-FBEVAR for degenerative and post-dissection cAAAs or TAAAs. METHODS: A single-center institutional database was retrospectively reviewed for patients that underwent PM-FBEVAR between 2015 and 2021. Infected aneurysms and pseudoaneurysms were excluded. Patient characteristics, intraoperative details, and clinical outcomes were compared between degenerative and post-dissection cAAAs or TAAAs. The primary outcome was 30-day mortality. The secondary outcomes included technical success, major complications, endoleak, target vessel instability, and reintervention. RESULTS: Of the 183 patients who underwent PM-FBEVAR in the study, 32 had aortic dissections, and 151 had degenerative aneurysms. There was one 30-day death (3.1%) in the post-dissection group and eight 30-day deaths (5.3%) in the degenerative aneurysm group (P = .99). Technical success, fluoroscopy time, and contrast usage were similar between the post-dissection and degenerative groups. Reintervention during follow-up (28% vs 35%; P = .54) and major complications were not statistically significantly different between the two groups. Endoleak was the most common reason for reintervention, with the post-dissection group having a higher rate of type IC, II, and IIIA endoleaks (31% vs 3%; P < .0001; 59% vs 26%; P = .0002; and 16% vs 4%; P = .03). During the mean follow-up of 14 months, all-cause mortality was similar between the groups (12.5% vs 21.9%; P = .23). CONCLUSIONS: PM-FBEVAR is a safe treatment for post-dissection cAAAs and TAAAs with high technical success. However, endoleaks requiring reintervention were more frequent in post-dissection patients. The impact of these reinterventions on long-term durability will be assessed with continued follow-up.


Subject(s)
Aortic Aneurysm, Abdominal , Aortic Aneurysm, Thoracic , Aortic Aneurysm, Thoracoabdominal , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Humans , Blood Vessel Prosthesis/adverse effects , Endoleak/etiology , Aortic Aneurysm, Thoracic/diagnostic imaging , Aortic Aneurysm, Thoracic/surgery , Aortic Aneurysm, Thoracic/complications , Blood Vessel Prosthesis Implantation/adverse effects , Retrospective Studies , Risk Factors , Treatment Outcome , Endovascular Procedures/adverse effects , Time Factors , Aortic Aneurysm, Abdominal/surgery
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