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1.
J Vasc Surg ; 2024 Apr 09.
Article in English | MEDLINE | ID: mdl-38604317

ABSTRACT

OBJECTIVE: Hospital volume is associated with mortality after open aortic aneurysm repair. Fenestrated and branched endovascular aortic repair (B-FEVAR) has been increasingly used for repair of complex thoracoabdominal and juxtarenal aneurysms, but evidence of a center-volume relationship is limited. We aimed to measure the association of center volume with in-hospital mortality, postoperative outcomes, and 1-year survival following B-FEVAR. METHODS: Patients undergoing elective endovascular thoracoabdominal and complex abdominal aneurysm repair with branch intervention (2014-2021) listed within the national Vascular Quality Initiative Thoracic Endovascular Aortic Repair/Complex EVAR database were analyzed. Centers were grouped into quartiles by mean annual procedure volume. Multivariable regression was used to evaluate the effect of center volume on in-hospital mortality adjusting for baseline and procedural characteristics. Kaplan-Meier estimation, log rank test, and mixed effects Cox regression were used to evaluate 1-year survival. RESULTS: A total of 4302 adult elective F-BEVAR procedures were identified at a total of 163 centers. In-hospital mortality did not differ by hospital volume (quartile [Q]1 = 35/1059 [3.3%]; Q2 = 30/1063 [2.8%]; Q3 = 33/1120 [2.9%]; and Q4 = 44/1060 [4.2%]; P = .308). The high volume group had a higher rate of major complication (Q1 = 14.9%; Q2 = 12.8%; Q3 = 13.3%; and Q4 = 20.1%; adjusted P < .001). Physician-modified grafts were more frequently employed in high-volume centers (Q1 = 4.5%; Q2 = 18.7%; Q3 = 11.3%; and Q4 = 19.2%; P < .001), with a decreased incidence of any endoleak noted at the end of the procedure (Q1 = 34.9%; Q2 = 32.8%; Q3 = 30.0%; and Q4 = 29.0%; P = .003). In the multivariable analysis, in-hospital mortality was not associated with center volume, comparing very low volume to medium- and high-volume centers (odds ratio [95% confidence interval] vs Q4: Q1 = 1.1 [0.6-1.9], Q2 = 0.6 [0.4-1.1], and Q3 = 0.9 [0.5-1.5]; all P > .05). No significant difference was found in 1-year survival between center volume groups. CONCLUSIONS: In-hospital mortality is not associated with procedure volume within centers performing complex endovascular aortic repair. However, complication rates and endoleak may be associated with procedure volume. Long-term outcomes by annualized procedure volume, specifically graft durability and sac expansion, should be investigated.

2.
Ann Vasc Surg ; 100: 155-164, 2024 Mar.
Article in English | MEDLINE | ID: mdl-37852366

ABSTRACT

BACKGROUND: Operative risk for supra-aortic trunk (SAT) surgical revascularization for occlusive disease, particularly transthoracic reconstruction (TR), remains ill-defined. This study sought to describe and compare 30-day outcomes of TR and extra-anatomic (ER) SAT surgical reconstruction for an occlusive indication across the United States over a contemporary 15-year period. METHODS: Using the National Surgical Quality Improvement Program, TR and ER performed during 2005-2019 were identified. Procedures performed for nonocclusive indications and those concomitant with coronary or valve operations were excluded. Rates of stroke, death, myocardial infarction (MI) and these as composite outcome (S/D/M) were compared. Logistic regression with stabilized inverse probability weighting (IPW) was used to compare groups via average treatment effect (ATE) while adjusting for covariate imbalances. RESULTS: Over the 15-year period, 166 TR and 1,900 ER patients were identified. The majority of ERs were carotid-subclavian bypass (n = 1,344; 70.7%) followed by carotid-carotid bypass (n = 261; 13.7%) and subclavian/carotid transpositions (n = 123; 6.5%). TR consisted of aorto-SAT bypass (n = 120; 72.3%) and endarterectomy (n = 46; 27.7%). The median age was 64 years for TR and 65 years in ER (P = 0.039). Those undergoing TR were more often women (69.0% vs. 56.9%; P = 0.001) and less likely to have undergone previous cardiac surgery (9.2% vs. 20.8%; P = 0.006). TR were also less frequently hypertensive (68.1% vs. 75.4%; P = 0.038) and had statistically lower preoperative creatinine levels (0.86 vs 0.91; P = 0.002). Unadjusted rates of MI (0.6% vs. 1.3%; P = 0.72) and stroke (3.6% vs. 1.9%; P = 0.15) were similar between groups with mortality (3.6% vs. 1.5%; P = 0.05) and S/D/M (6.6% vs. 3.9%; P = 0.10) trending higher with TR. IPWs could be calculated for 1,754 patients (148 TR; 1,606 ER). The estimated probability of S/D/M was 3.8% in the ER group and 6.2% in TR; no difference was seen in ATE (2.4%; 95% confidence interval [CI]: -1.5 to 6.2; P = 0.23). No differences were seen in individual component ATEs (stroke: 3.0% vs. 1.7%; ATE = 1.3%; 95% CI: -3.9 to 1.3; P = 0.32; mortality: 3.8% vs. 1.4%; ATE = 2.4%; 95% CI: -5.6 to 0.7; P = 0.13). Secondary outcomes showed TR patients were more likely to have non-home discharge (18.7% vs. 6.6%; ATE = 12.1%; 95% CI: 5.0-19.2; P < 0.001) and longer lengths of stay (6.1 vs. 4.0; ATE = 2.2 days; 95% CI: 0.9-3.4; P < 0.001). Moreover, TR patients were more likely to require transfusion (22.7% vs. 5.0%; ATE = 17.7%; 95% CI: 10.2-25.2; P < 0.001) and develop sepsis (2.7% vs. 0.2%; ATE = 2.5%; 95% CI: 0.1-5.0; P = 0.04). CONCLUSIONS: Transthoracic and extra-anatomic surgical reconstruction of the SATs for occlusive disease have similar operative cardiovascular risk. However, morbidity tends to be higher with TR due to higher transfusion requirements, sepsis risk, and need for facility stay. These results suggest ER as a first-line approach in those with proper disease anatomy is reasonable with lower morbidity, while TR remains justified in appropriate patients.


Subject(s)
Carotid Stenosis , Endarterectomy, Carotid , Myocardial Infarction , Sepsis , Stroke , Humans , Female , United States , Middle Aged , Carotid Stenosis/surgery , Treatment Outcome , Myocardial Infarction/etiology , Morbidity , Retrospective Studies , Risk Factors , Endarterectomy, Carotid/adverse effects
3.
Ann Surg ; 278(2): 172-178, 2023 08 01.
Article in English | MEDLINE | ID: mdl-36728522

ABSTRACT

OBJECTIVE: The aim was to analyze the risk of progression to chronic limb-threatening ischemia (CLTI), amputation and subsequent interventions after revascularization versus noninvasive therapy in patients with intermittent claudication (IC). BACKGROUND: Conflicting evidence exists regarding adverse limb outcomes after each treatment strategy. METHODS: Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were followed. MEDLINE, Web of Science, and Google Scholar were searched aided by a health sciences librarian through August 16, 2022. Randomized control trials (RCTs) comparing invasive (endovascular or surgical revascularization) and noninvasive treatment (exercise and/or medical treatment) were included. PROSPERO registration was completed (CRD42022352831). RESULTS: A total of 9 RCTs comprising 1477 patients (invasive, 765 patients; noninvasive, 712 patients) were eligible. During a mean of 3.6-year follow-up, progression to CLTI after invasive [5 (2-8) per 1000 person-years] and noninvasive treatment [6 (3-10) per 1000 person-years] were not statistically different [rate ratio (RR): 0.77; 95% CI, 0.35-1.69; P =0.51, I2 =0%]. Incidence of amputation (RR: 1.69; 95% CI, 0.54-5.26; P =0.36, I2 =0%) and all-cause mortality (hazard ratio: 1.26; 95% CI, 0.91-1.74; P =0.16, I2 =0%) also did not differ between the groups. However, the invasive treatment group underwent significantly more revascularizations (RR: 4.15; 95% CI, 2.80-6.16; P <0.00001, I2 =83%). The results were not changed by fixed effect or random-effects models, nor by sensitivity analysis. CONCLUSIONS: Although there is equivalent risk of progression to CLTI, major amputation and all-cause mortality compared with noninvasive treatment, invasive treatment for patients with IC led to significantly more revascularization procedures and should be used selectively in patients with major lifestyle limitation. Guideline recommendation of noninvasive treatment for first-line IC therapy is supported.


Subject(s)
Endovascular Procedures , Peripheral Arterial Disease , Humans , Endovascular Procedures/adverse effects , Exercise Therapy , Intermittent Claudication/surgery , Intermittent Claudication/etiology , Ischemia/etiology , Peripheral Arterial Disease/complications , Peripheral Arterial Disease/surgery , Risk Factors , Treatment Outcome , Vascular Surgical Procedures/adverse effects , Randomized Controlled Trials as Topic
4.
J Vasc Surg ; 77(5): 1424-1433.e1, 2023 05.
Article in English | MEDLINE | ID: mdl-36681256

ABSTRACT

OBJECTIVE: Optimal temporal surgical management of significant carotid stenosis and coronary artery disease remains unknown. Carotid endarterectomy (CEA) and coronary artery bypass (CABG) are performed concurrently (CCAB) or in a staged (CEA-CABG or CABG-CEA) approach. Using the Vascular Quality Initiative-Vascular Implant Surveillance and Interventional Outcomes Coordinated Registry Network-Medicare-linked dataset, this study compared operative and long-term outcomes after CCAB and staged approaches. METHODS: The Vascular Quality Initiative-Vascular Implant Surveillance and Interventional Outcomes Coordinated Registry Network dataset was used to identify CEAs from 2011 to 2018 with combined CABG or CABG within 45 days preceding or after CEA. Patients were stratified based on concurrent or staged approach. Primary outcomes were stroke, myocardial infarction (MI), all-cause mortality, stroke and death as composite (SD) and all as composite within 30 days from the last procedure as well as in the long term. Univariate analysis and risk-adjusted analysis using inverse propensity weighting were performed. Kaplan-Meier curves of stroke, MI, and death were created and compared. RESULTS: There were 1058 patients included: 643 CCAB and 415 staged (309 CEA-CABG and 106 CABG-CEA). Compared with staged patients, those undergoing CCAB had a higher preoperative rate of congestive heart failure (24.8% vs 18.4%; P = .01) and decreased renal function (14.9% vs 8.5%; P < .01), as well as fewer prior neurological events (23.5% vs 31.4%; P < .01). Patients undergoing CCAB had similar weighted rate of 30-day stroke (4.6% vs 4.1%; P = .72), death (7.0% vs 5.0%; P = .32), and composite outcomes (stroke and death, 9.8% vs 8.5%; P = .56; stroke, death, and MI, 14.7% vs 17.4%; P = .31), but a lower weighted rate of MI (5.5% vs 11.5%; P < .01) vs the staged cohort. Long-term adjusted risks of stroke (hazard ratio [HR], 0.85; 95% confidence interval [CI], 0.54-1.36; P = .51) and mortality (HR, 1.02; 95% CI, 0.76-1.36; P=.91) were similar between groups, but higher risk of MI long-term was seen in those staged (HR, 1.49; 95% CI, 1.07-2.08; P = .02). CONCLUSIONS: In patients undergoing CCAB or staged open revascularization for carotid stenosis and coronary artery disease, the staged approach had an increased risk of postoperative cardiac event, but the short- and long-term rates of stroke and mortality seem to be comparable. Adverse cardiovascular event risk is high between operations when staged and should be a consideration when selecting an approach. Although factors leading to staged sequencing performance need further clarity, CCAB seems to be safe and should be considered an equally reasonable option.


Subject(s)
Carotid Stenosis , Coronary Artery Disease , Endarterectomy, Carotid , Myocardial Infarction , Stroke , Humans , Aged , United States , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/surgery , Carotid Stenosis/complications , Carotid Stenosis/diagnostic imaging , Carotid Stenosis/surgery , Treatment Outcome , Retrospective Studies , Medicare , Coronary Artery Bypass , Myocardial Infarction/etiology , Stroke/etiology , Risk Factors
5.
J Vasc Surg ; 75(4): 1343-1348.e2, 2022 04.
Article in English | MEDLINE | ID: mdl-34838611

ABSTRACT

OBJECTIVE: An aberrant right subclavian artery (ARSA) is the most common congenital anomaly of the aortic arch. A paucity of reported studies is available regarding the treatment of these patients. The purpose of the present study was to evaluate the contemporary management strategies and natural history of ARSA in these patients. METHODS: A single-center retrospective review of patients with a diagnosis of ARSA from 2009 to 2019 was performed. Computed tomography scans were analyzed, and the aortic and ARSA diameters were measured at 10 different segments. The demographic data, comorbidities, and operative interventions were collected. The patients were categorized into those who had undergone intervention and those who had undergone expectant management. Linear mixed effect models were used to estimate the annual ARSA diameter changes. RESULTS: A total of 30 patients with ARSA were identified, 17 (57%) of whom were women. The average age for the cohort was 54.5 ± 14.6 years. Of the 30 patients, 20 (67%) had undergone operative repair at presentation and 10 (33%) were initially observed. The most common presenting symptom was dysphagia (30%). Of the 10 patients who had been initially treated expectantly, 4 had subsequently required intervention. Of the 24 operative interventions, 13 (54%) were hybrid procedures involving right carotid-subclavian bypass or transposition and thoracic endovascular aortic repair. The mean diameter of ARSA at its origin was 20.4 ± 5.7 mm, and the mean cross-sectional aortic diameter at the level of the ARSA was 31.8 ± 8.5 mm for the entire cohort. For the patients who had initially been observed and had subsequently required intervention, the largest change in the ARSA cross-sectional diameter was observed 1 cm distally to the vessel ostium at a rate of 3.05 mm annually (95% confidence interval, 1.54-4.56; P < .001). No statistically significant changes in the annual growth rate of the aortic segments were observed in the entire cohort or for those patients who had undergone intervention (P > .05). CONCLUSIONS: The decision to intervene on an ARSA should be individualized by the presence of symptoms (eg, dysphagia lusoria) or complications (eg, dissection, concomitant aortic aneurysmal disease, enlarging Kommerell diverticulum). Asymptomatic patients with nonaneurysmal ARSA might not require any intervention and can be safely observed. Measurement of the cross-sectional ARSA diameter 1 cm distally to the ostium of the vessel might aid in the surveillance of vessel diameter changes. Additional studies are required to determine the specific size criteria as an indication for operative repair of asymptomatic Kommerell diverticulum.


Subject(s)
Blood Vessel Prosthesis Implantation , Cardiovascular Abnormalities , Deglutition Disorders , Diverticulum , Endovascular Procedures , Adult , Aged , Aorta, Thoracic/abnormalities , Aorta, Thoracic/diagnostic imaging , Aorta, Thoracic/surgery , Blood Vessel Prosthesis Implantation/adverse effects , Cardiovascular Abnormalities/complications , Cardiovascular Abnormalities/diagnostic imaging , Cardiovascular Abnormalities/surgery , Deglutition Disorders/etiology , Deglutition Disorders/surgery , Diverticulum/surgery , Endovascular Procedures/adverse effects , Female , Humans , Male , Middle Aged , Subclavian Artery/abnormalities , Subclavian Artery/diagnostic imaging , Subclavian Artery/surgery , Treatment Outcome
6.
J Vasc Surg ; 75(2): 495-503.e5, 2022 02.
Article in English | MEDLINE | ID: mdl-34500026

ABSTRACT

OBJECTIVE: Limited data exists on management and outcomes of patients presenting with type A aortic dissection (TAAD) and acute lower extremity ischemia (ALI). The role of limb-related revascularization and optimal treatment strategy remains undefined. The objective of this study was to analyze dissection characteristics, treatment modalities, and outcomes of patients undergoing proximal aortic repair for TAAD with ALI. METHODS: Consecutive patients who underwent proximal aortic repair for TAAD were identified from a prospectively maintained database. Clinical data, imaging, operative details, and outcomes of patients with TAAD and ALI were retrospectively analyzed. Kaplan-Meier methodology was used to estimate overall and amputation-free survival. Log-rank tests were used to compare overall curves. Predictors of revascularization and in-hospital mortality were determined using multivariable logistic regression analysis. RESULTS: From 2010 to 2018, 463 patients with TAAD underwent proximal aortic repair. A total of 81 patients (17%) presented with ALI; 48% (39/81) with isolated ALI, and 52% (42/81) with ALI and renovisceral malperfusion. Thirty percent (24/81) required revascularization in addition to proximal aortic repair. Revascularization strategies involved endovascular (46%; 11/24), open (33%; 8/24), and hybrid (21%; 5/24) interventions. The major amputation rate was 4% (3/81), and in-hospital mortality was 21% (17/81). Amputation-free survival was significantly lower in patients requiring revascularization compared with those who did not (log-rank P = .023). Overall survival did not significantly differ between the two groups (log-rank P = .095). Overall survival was significantly lower in patients with concomitant ALI and renovisceral malperfusion compared with those with isolated ALI (log-rank P = .0017). Distal extent of dissection flap into zone 11 (odds ratio [OR], 5.65; 95% confidence interval [CI], 1.58-20.2; P = .008) and partial/complete thrombosis of any iliac artery (OR, 3.94; 95% CI, 1.23-12.6; P = .021) were associated with increased risk of requiring an additional revascularization procedure. True lumen collapse at level of renovisceral aorta (OR, 8.84; 95% CI, 1.74-44.9; P = .0086) was associated with increased risk of in-hospital mortality. CONCLUSIONS: ALI resolves after proximal aortic repair of TAAD in most cases. Distal extent of aortic dissection into zone 11 and iliac thrombosis are risk factors for additional peripheral revascularization. True lumen collapse at the renovisceral aorta and TAAD with concomitant ALI and renovisceral malperfusion portends a poor prognosis. A multi-disciplinary team approach to manage these patients who present with ascending aortic dissection and distal malperfusion may improve outcomes in this complex population.


Subject(s)
Aortic Aneurysm, Thoracic/complications , Aortic Dissection/complications , Endovascular Procedures/methods , Ischemia/etiology , Lower Extremity/blood supply , Acute Disease , Aortic Dissection/diagnosis , Aortic Dissection/surgery , Aortic Aneurysm, Thoracic/diagnosis , Aortic Aneurysm, Thoracic/surgery , Female , Follow-Up Studies , Hospital Mortality/trends , Humans , Incidence , Ischemia/epidemiology , Ischemia/surgery , Male , Middle Aged , Retrospective Studies , Risk Factors , Survival Rate/trends , Treatment Outcome , United States/epidemiology
7.
Eur J Vasc Endovasc Surg ; 64(1): 15-22, 2022 07.
Article in English | MEDLINE | ID: mdl-35537643

ABSTRACT

OBJECTIVE: To clarify the natural history of abdominal aortic ectasia (AAE) measuring 25 - 29 mm in maximum diameter, and to determine the optimal follow up based on the growth, risk of rupture, and overall mortality of AAE. DATA SOURCES: MEDLINE, Web of Science Core Collection, and Google Scholar. REVIEW METHODS: This was a systematic review and meta-analysis of AAE in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. MEDLINE, Web of Science Core Collection, and Google Scholar were searched, with the help of a health sciences librarian, up to 11 August 2021. Studies with longitudinal outcomes of AAE (prevalence, annual growth rate, aneurysmal enlargement, rupture, aneurysm related death, and all cause mortality) were included. Meta-analyses were conducted with a random effects model RESULTS: Twelve studies describing a total of 8 369 patients were eligible. The prevalence at population based settings was 3.2% (95% confidence interval [CI] 2.4 - 4.0); annual growth rate was 0.82 mm/year (95% CI 0.20 - 1.45). The estimated risks of aortic diameters exceeding 30 mm and 55 mm in five years were 45.0% (95% CI 28.5 - 61.5) and 0.3% (95% CI 0 - 0.6) respectively, while those beyond five years were 70.2% (95% CI 46.9 - 93.6) and 5.2% (95% CI 2.2 - 8.2). The rates of rupture and aneurysm related death were minimal until five years (0.1% and 0.1%, respectively) and beyond (0.4% and 0.2%, respectively). Overall mortality was 7.5% (95% CI 3.9 - 11.0) and 17.3% (95% CI 9.5 - 25.1) up to and beyond five years. Overall mortality from three studies showed no statistical difference between AAE and aneurysms (hazard ratio 0.62, 95% CI 0.32 - 1.21; p = .16). Cancer (35.0%) and cardiovascular diseases (31.9%) were major causes of death. CONCLUSION: AAE carries minimal risk of aneurysm related lethal events during the first five years, but a similar overall mortality risk as abdominal aortic aneurysm. Cancer and cardiovascular diseases are leading causes of death in patients with AAE.

8.
J Vasc Surg ; 73(3): 819-825, 2021 03.
Article in English | MEDLINE | ID: mdl-32707376

ABSTRACT

OBJECTIVE: The ideal mating stent for target vessel revascularization in fenestrated endovascular aneurysm repair (FEVAR) of juxtarenal and thoracoabdominal aortic aneurysms remains unknown. The objective of this study was to assess the outcomes associated with use of different stent types and configurations mated with reinforced fenestrations during FEVAR. METHODS: Clinical data from patients undergoing FEVAR for juxtarenal and thoracoabdominal aortic aneurysms in a prospective physician-sponsored investigational device exemption trial were analyzed. Outcomes for two different balloon-expandable covered stents (BECSs) mated with reinforced fenestrations were assessed along with the impact of distal extension with a self-expanding stent (SES). Primary patency, branch-related endoleak, and reintervention rates were determined. Cox proportional hazards model was used for time-to-event analysis. RESULTS: From 2001 to 2016, there were 918 patients who underwent fenestrated or branched endograft repair of complex aortic aneurysms; 1604 renal arteries (RAs), 714 superior mesenteric arteries (SMAs), and 333 celiac arteries (CAs) were mated with reinforced fenestrations using JOMED (n = 2014; Abbott Vascular, Santa Clara, Calif) or iCAST (n = 637; Atrium Medical, Hudson, NH) BECSs. The type of BECS did not affect short-term or long-term patency, branch-related endoleaks, or reintervention rates in the RA, SMA, or CA. Twenty-five percent (402/1604) of RAs, 84% (598/714) of SMAs, and 8% (27/333) of CAs underwent distal SES extension at the index operation. RAs with a distal SES in addition to the BECS had a higher likelihood of an occlusion event (hazard ratio, 2.791; 95% confidence interval, 1.42-5.48; P = .003) and reinterventions (P = .036) compared with those without an SES. Addition of a distal SES to the BECS in the SMA or CA did not have an impact on patency or reintervention rates. CONCLUSIONS: BECS choice does not appear to have an impact on branch durability after FEVAR. Selective distal SES placement in RAs with high-risk anatomy does not appear to significantly protect against an occlusion event or to prevent secondary interventions. Routine addition of a distal SES does not improve SMA fenestration durability.


Subject(s)
Angioplasty, Balloon/instrumentation , Aortic Aneurysm, Abdominal/surgery , Aortic Aneurysm, Thoracic/surgery , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis , Prosthesis Design , Stents , Aged , Aged, 80 and over , Angioplasty, Balloon/adverse effects , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/physiopathology , Aortic Aneurysm, Thoracic/diagnostic imaging , Aortic Aneurysm, Thoracic/physiopathology , Blood Vessel Prosthesis Implantation/adverse effects , Endoleak/etiology , Endoleak/therapy , Female , Graft Occlusion, Vascular/etiology , Graft Occlusion, Vascular/therapy , Humans , Male , Ohio , Prospective Studies , Retreatment , Risk Assessment , Risk Factors , Time Factors , Treatment Outcome , Vascular Patency
9.
J Endovasc Ther ; 28(5): 796-803, 2021 10.
Article in English | MEDLINE | ID: mdl-34142900

ABSTRACT

OBJECTIVES: Intraprocedural deployment of endovascular devices during complex aortic repair with 2-dimensional (2D) x-ray fluoroscopic guidance poses challenges in terms of accurate delivery system positioning and increased risk of x-ray radiation exposure with prolonged fluoroscopy times, particularly in unfavorable anatomy. The objective of this study was to assess feasibility of using an augmented reality (AR) system to position and orient a modified aortic endograft delivery system in comparison with standard fluoroscopy. MATERIALS AND METHODS: The 3-dimensional guidance, navigation, and control (3D-GNC) prototype system was developed for eventual integration with the Intra-Operative Positioning System (IOPS, Centerline Biomedical, Cleveland, OH) to project spatially registered 3D holographic representations of the subject-specific aorta for intraoperative guidance and coupled with an electromagnetically (EM) tracked delivery system for intravascular navigation. Numerical feedback for controlling the endograft landing zone distance and ostial alignment was holographically projected on the operative field. Visualization of the holograms was provided via a commercially available AR headset. A Zenith Spiral-Z AAA limb stent-graft was modified with a scallop, 6 degree-of-freedom EM sensor for tracking, and radiopaque markers for fluoroscopic visualization. In vivo, 10 interventionalists independently positioned and oriented the delivery system to the ostia of renal or visceral branch vessels in anesthetized swine via open femoral artery access using 3D-GNC and standard fluoroscopic guidance. Procedure time, fluoroscopy time, cumulative air kerma, and contrast material volume were recorded for each technique. Positioning and orientation accuracy was determined by measuring the target landing-zone distance error (δLZE) and the scallop-ostium angular alignment error (θSOE) using contrast-enhanced cone beam computed tomography imaging after each positioning for each technique. Mean, standard deviation, and standard error are reported for the performance variables, and Student's t tests were used to evaluate statistically significant differences in performance mean values of 3D-GNC and fluoroscopy. RESULTS: Technical success for the use of 3D-GNC to orient and position the endovascular device at each renal-visceral branch ostium was 100%. 3D-GNC resulted in 56% decrease in procedure time in comparison with standard fluoroscopic guidance (p<0.001). The 3D-GNC system was used without fluoroscopy or contrast-dye administration. Positioning accuracy was comparable for both techniques (p=0.86), while overall orientation accuracy was improved with the 3D-GNC system by 41.5% (p=0.008). CONCLUSIONS: The holographic 3D-GNC system demonstrated improved accuracy of aortic stent-graft positioning with significant reductions in fluoroscopy time, contrast-dye administration, and procedure time.


Subject(s)
Endovascular Procedures , Animals , Aorta , Endovascular Procedures/adverse effects , Feasibility Studies , Fluoroscopy , Imaging, Three-Dimensional , Stents , Swine , Treatment Outcome , X-Rays
10.
J Vasc Surg ; 72(4): 1222-1228, 2020 10.
Article in English | MEDLINE | ID: mdl-32093914

ABSTRACT

OBJECTIVE: The outcomes of subclavian artery revascularization (SAR) have been examined extensively in the setting of atherosclerotic occlusive disease but have been poorly characterized in the setting of thoracic endovascular aortic repair (TEVAR). As trials for branched thoracic endovascular stent grafts materialize, the outcomes of the subclavian artery branched prosthesis will need to be compared with TEVAR with SAR by carotid-subclavian bypass or subclavian transposition. METHODS: A database of 1516 patients undergoing TEVAR from 2000 to 2015 was queried. Of those undergoing TEVAR, 19% (282 patients) also underwent SAR. Patient demographics, TEVAR indication, 30-day morbidity and mortality, and midterm patency and survival were analyzed. RESULTS: During the study period, 282 patients underwent 288 SARs in the setting of TEVAR. A total of 269 (93%) carotid-subclavian bypasses and 19 (7%) subclavian artery transpositions were performed; 76% of the SARs occurred before TEVAR, 14% occurred concurrently with TEVAR, and 10% occurred after TEVAR. The most common indications for TEVAR was aortic aneurysm (56%), chronic aortic dissection with aneurysmal degeneration (23%), and aortic dissections (13%). The 30-day ipsilateral stroke rate was 3.5%. Eight patients (2.8%) underwent an unplanned return to the operating room (2.1% for hematoma evacuation and 0.7% for management of chyle leak). Six patients (2.1%) sustained a nerve injury. The mean follow-up was 4.2 years. All-cause 30-day mortality was 4.6%. The overall survival rates at 1 year, 5 years, and 10 years were 82%, 60%, and 42%, respectively. The median survival was 7.2 years. Four patients were found to have a failure in primary patency during follow-up. All four patients had undergone a carotid-subclavian bypass. The 1-, 2-, and 5-year primary patency rates were 99.5%, 98.9%, and 98.0%, respectively, for carotid-subclavian bypass and 100% for carotid-subclavian transposition. CONCLUSIONS: During our 16-year study, we found SAR in the setting of TEVAR to be associated with low morbidity, durable long-term patency, and infrequent need for reintervention.


Subject(s)
Aortic Aneurysm, Thoracic/surgery , Aortic Dissection/surgery , Endovascular Procedures/methods , Postoperative Complications/epidemiology , Stroke/epidemiology , Subclavian Artery/surgery , Adult , Aged , Aged, 80 and over , Aortic Dissection/etiology , Aortic Dissection/mortality , Aorta, Thoracic/surgery , Aortic Aneurysm, Thoracic/complications , Endovascular Procedures/adverse effects , Endovascular Procedures/instrumentation , Female , Follow-Up Studies , Hospital Mortality , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Postoperative Complications/etiology , Reoperation/statistics & numerical data , Retrospective Studies , Risk Factors , Stroke/etiology , Treatment Outcome , Vascular Patency , Young Adult
12.
J Vasc Surg ; 68(6): 1676-1687.e3, 2018 12.
Article in English | MEDLINE | ID: mdl-29937284

ABSTRACT

OBJECTIVE: The incidence of failed endovascular aneurysm repair (EVAR) is increasing, and understanding the different methods of management and repair is paramount. The objective of this study was to evaluate the clinical management and rescue of failed EVAR by either explantation or fenestrated-branched EVAR (F/B-EVAR). METHODS: A retrospective analysis (1999-2016) of 247 patients who underwent either explantation (n = 162) or F/B-EVAR (n = 85) for failed EVAR was performed. F/B-EVAR was performed under a physician-sponsored investigational device exemption. Demographics of the patients, clinical presentation and failure etiology, perioperative management, rate of reinterventions, morbidity, and mortality were analyzed. Those undergoing surgical explantation were compared with those undergoing F/B-EVAR conversion. Statistical analysis included multivariable logistic regressions, Fisher exact test, and χ2 test. RESULTS: The majority of patients were male (n = 216 [87%]), with a mean age of 75 years (range, 50-93 years). The mean time from primary EVAR was higher in F/B-EVAR (46 ± 7 months vs 69 ± 41 months; P < .001). Graft manufacturer did not differ between those requiring explantation and those having endovascular rescue (P = .170). All emergencies (n = 24 [10%]) and infections (n = 28 [11%]) were treated with open conversion. Endoleak was the most common reason for failure in both explantation and F/B-EVAR groups (75% vs 64%, respectively; P = .052). Type I endoleak was the most common endoleak reported in both groups, occurring more frequently in F/B-EVAR (64% vs 40%; P < .001); type II endoleak was more common in those undergoing open repair (28% vs 2%; P < .001). Graft migration (12% vs 26%; P = .005) and neck degeneration/disease progression (14% vs 59%; P < .001) were more prevalent in F/B-EVAR, but aneurysm enlargement was more common in explantation (68% vs 33%; P < .001). Thirty-day reintervention rates did not differ between F/B-EVAR and explantation (odds ratio, 0.6258; 95% confidence interval, 0.2-1.86; P = .4115); however, 30-day mortality was lower in the F/B-EVAR group (5% vs 10%; P = .0192). Similarly, aneurysm-related mortality was also lower in the F/B-EVAR group (hazard ratio, 0.0683; 95% confidence interval, 0.01-0.44; P = .0048). A subset analysis excluding emergencies and infections did not alter the lack of difference in terms of freedom from reinterventions (P = .1175), 30-day mortality (P = .6329), or aneurysm-related mortality (P = .7849). CONCLUSIONS: Explantation and F/B-EVAR are necessary options in treating patients with failed EVAR, and both techniques have competitive results. Different modes of failure may point to a preferred method of treatment; consequently, rescue of failed EVAR should be individualized according to each patient's presentation and resources available.


Subject(s)
Aortic Aneurysm, Abdominal/surgery , Aortic Aneurysm, Thoracic/surgery , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis , Device Removal , Endovascular Procedures/instrumentation , Postoperative Complications/surgery , Aged , Aged, 80 and over , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/mortality , Aortic Aneurysm, Thoracic/diagnostic imaging , Aortic Aneurysm, Thoracic/mortality , Aortic Aneurysm, Thoracic/physiopathology , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/mortality , Device Removal/adverse effects , Device Removal/mortality , Endovascular Procedures/adverse effects , Endovascular Procedures/mortality , Female , Humans , Male , Middle Aged , Postoperative Complications/diagnostic imaging , Postoperative Complications/etiology , Postoperative Complications/mortality , Prosthesis Design , Reoperation , Retrospective Studies , Risk Factors , Time Factors , Treatment Failure
13.
J Vasc Surg ; 76(2): 607, 2022 08.
Article in English | MEDLINE | ID: mdl-35870851
14.
J Vasc Surg ; 66(1): 95-101, 2017 07.
Article in English | MEDLINE | ID: mdl-28216366

ABSTRACT

OBJECTIVE: Hypogastric artery embolization (HAE) is associated with significant risk of ischemic complications. We assessed the impact of HAE on 30-day outcomes of endovascular aneurysm repair (EVAR) of infrarenal abdominal aortic aneurysms. METHODS: We queried the American College of Surgeons National Surgical Quality Improvement Program database from 2011 to 2014 to identify and to compare clinical features, operative details, and 30-day outcomes of EVAR with those of concomitant HAE with EVAR (HAE + EVAR). Multivariate analysis was performed to determine preoperative and intraoperative factors associated with development of significant complications observed in patients with HAE + EVAR. RESULTS: In a cohort of 5881 patients, 387 (6.6%) underwent HAE + EVAR. Compared with EVAR, a higher incidence of ischemic colitis (2.6% vs 0.9%; P = .002), renal failure requiring dialysis (2.8% vs 1%; P = .001), pneumonia (2.6% vs 1.3%; P = .039), and perioperative blood transfusion (17% vs 13%; P = .024) was noted after HAE + EVAR. Thirty-day thromboembolic events, strokes, myocardial infarction, lower extremity ischemia, reoperation, and readmission rates were not significantly different (P > .05). Mortality at 30 days in HAE + EVAR patients was 4.1% compared with 2.5% with EVAR (P = .044). HAE was independently associated with increased risk of colonic ischemia (adjusted odds ratio, 2.98; 95% confidence interval, 1.44-6.14; P = .003) and renal failure requiring dialysis (adjusted odds ratio, 2.22; 95% confidence interval, 1.09-4.53; P = .029). However, HAE was not an independent predictor of mortality. Average length of hospital stay was 4 ± 8.5 days after HAE + EVAR vs 3.3 ± 5.9 days after EVAR (P = .001). CONCLUSIONS: Concomitant HAE with EVAR is associated with longer and more complicated hospital stays. Ischemic colitis is a rare complication of EVAR. HAE increases the risk of ischemic colitis and renal failure requiring dialysis. This study highlights the importance of hypogastric artery preservation during EVAR.


Subject(s)
Aortic Aneurysm, Abdominal/therapy , Blood Vessel Prosthesis Implantation/adverse effects , Colitis, Ischemic/etiology , Embolization, Therapeutic/adverse effects , Endovascular Procedures/adverse effects , Pelvis/blood supply , Renal Insufficiency/etiology , Aged , Aged, 80 and over , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/physiopathology , Aortic Aneurysm, Abdominal/surgery , Arteries/physiopathology , Chi-Square Distribution , Colitis, Ischemic/diagnosis , Colitis, Ischemic/therapy , Databases, Factual , Embolization, Therapeutic/methods , Female , Humans , Length of Stay , Logistic Models , Male , Middle Aged , Multivariate Analysis , Odds Ratio , Regional Blood Flow , Registries , Renal Dialysis , Renal Insufficiency/diagnosis , Renal Insufficiency/therapy , Retrospective Studies , Risk Factors , Time Factors , Treatment Outcome , United States
15.
J Vasc Surg ; 66(4): 1028-1036.e18, 2017 10.
Article in English | MEDLINE | ID: mdl-28502545

ABSTRACT

OBJECTIVE: This study evaluated and compared the long-term clinical outcomes of endovascular repair of infrarenal aortoiliac aneurysms (EVAR) vs EVAR with preservation of antegrade internal iliac artery (IIA) perfusion using iliac branched devices (EVAR-IBDs). METHODS: From October 1998 to August 2015, patients with infrarenal aortoiliac aneurysmal (AIA) disease at high risk for conventional open surgery were enrolled in a prospective physician-sponsored investigational device exemption trial. Clinical data of 75 patients treated with EVAR-IBD and 255 with standard EVAR were analyzed. Technical success, perioperative outcomes, mortality, device patency, endoleak rates, and reinterventions during a follow-up of 10 years were analyzed. RESULTS: There were 87 IBDs deployed in 75 patients. Technical success rate was 97%. Mortality at 30 days was 1.3%. Freedom from aneurysm-related mortality at 3, 5, and 10 years was 99%. Freedom from a type I or III endoleak at 3, 5, and 10 years was 99%. Freedom from secondary reinterventions at 3, 5, and 10 years was 86%, 81%, and 81%, respectively. Primary patency of the IBDs at 3, 5, and 10 years was 94%, 94%, and 77%, respectively. Twenty-four percent of patients underwent EVAR for concomitant AIA disease (EVAR-AIA), and 78% were managed by staged IIA embolization before EVAR. No statistically significant difference in freedom from aneurysm-related mortality, limb occlusions, or endoleak rates was identified in patients with EVAR-AIA vs EVAR-IBD (P > .05). There were significantly more secondary reinterventions in the EVAR-AIA group compared with the EVAR-IBD group (hazard ratio, 0.476, 95% confidence interval, 0.226-1.001; P = .045). CONCLUSIONS: EVAR of infrarenal AIAs with preservation of antegrade flow to the IIA using IBDs is feasible with long-term sustained durability. Serious considerations should be given to the use of IBDs in patients with infrarenal AIAs meeting appropriate anatomic criteria.


Subject(s)
Aortic Aneurysm, Abdominal/surgery , Blood Vessel Prosthesis Implantation/methods , Endovascular Procedures/methods , Iliac Aneurysm/surgery , Iliac Artery/surgery , Aged , Aged, 80 and over , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/mortality , Aortic Aneurysm, Abdominal/physiopathology , Blood Vessel Prosthesis , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis Implantation/mortality , Disease-Free Survival , Endovascular Procedures/adverse effects , Endovascular Procedures/instrumentation , Endovascular Procedures/mortality , Feasibility Studies , Female , Humans , Iliac Aneurysm/diagnostic imaging , Iliac Aneurysm/mortality , Iliac Aneurysm/physiopathology , Iliac Artery/diagnostic imaging , Iliac Artery/physiopathology , Kaplan-Meier Estimate , Male , Ohio , Postoperative Complications/mortality , Postoperative Complications/therapy , Prospective Studies , Prosthesis Design , Regional Blood Flow , Risk Factors , Time Factors , Treatment Outcome , Vascular Patency
16.
Ann Vasc Surg ; 42: 302.e15-302.e20, 2017 Jul.
Article in English | MEDLINE | ID: mdl-28390914

ABSTRACT

Blunt thoracic aortic injury (BTAI) in a patient with an aberrant right subclavian artery (ARSA) presents unique challenges for patient management and aortic repair. Specific considerations include the need to treat coincidental ARSA, subclavian revascularization, and ARSA exclusion. Despite the rise of endovascular repair as the primary modality for aortic repair for BTAI, reports of this technique in the setting of ARSA are limited. Here we describe 3 patients with ARSA who underwent TEVAR for BTAI, and discuss critical management and technical issues in these patients.


Subject(s)
Accidents, Traffic , Aneurysm/complications , Aorta, Thoracic/surgery , Blood Vessel Prosthesis Implantation , Cardiovascular Abnormalities/complications , Endovascular Procedures , Subclavian Artery/abnormalities , Thoracic Injuries/surgery , Vascular System Injuries/surgery , Wounds, Nonpenetrating/surgery , Adult , Aneurysm/diagnostic imaging , Aorta, Thoracic/diagnostic imaging , Aorta, Thoracic/injuries , Aortography/methods , Blood Vessel Prosthesis , Blood Vessel Prosthesis Implantation/instrumentation , Cardiovascular Abnormalities/diagnostic imaging , Computed Tomography Angiography , Endovascular Procedures/instrumentation , Female , Humans , Male , Middle Aged , Prosthesis Design , Subclavian Artery/diagnostic imaging , Thoracic Injuries/diagnostic imaging , Thoracic Injuries/etiology , Treatment Outcome , Vascular System Injuries/diagnostic imaging , Vascular System Injuries/etiology , Wounds, Nonpenetrating/diagnostic imaging , Wounds, Nonpenetrating/etiology
17.
Ann Vasc Surg ; 28(8): 1934.e7-1934.e11, 2014 Nov.
Article in English | MEDLINE | ID: mdl-25038316

ABSTRACT

Carotid blowout is a rare fatal complication most commonly observed in head and neck cancer patients, especially after radiation therapy. Traditional surgical approaches carry extremely high morbidity and mortality rates. We present a case of acute hemorrhage from extracranial carotid artery in a 64-year-old man with history of total laryngectomy, tracheostomy, and chemoradiotherapy for laryngeal cancer. Tumor was noted to be encasing and eroding into the internal and common carotid artery with a large soft tissue neck defect. Hemorrhage was successfully controlled employing 3 Viabahn covered stents of increasing diameter in the internal and common carotid artery in an overlapping fashion under local anesthesia. Deployment of tapering overlapped covered stents in common and internal carotid artery may safely be performed to obtain endovascular control of active hemorrhage in a hostile neck.


Subject(s)
Carotid Artery Diseases/therapy , Carotid Artery, Internal/radiation effects , Endovascular Procedures/instrumentation , Hemorrhage/therapy , Laryngeal Neoplasms/radiotherapy , Radiation Injuries/therapy , Stents , Acute Disease , Carotid Artery Diseases/diagnosis , Carotid Artery Diseases/etiology , Carotid Artery, Internal/diagnostic imaging , Hemorrhage/diagnosis , Hemorrhage/etiology , Humans , Male , Middle Aged , Prosthesis Design , Radiation Injuries/diagnosis , Radiation Injuries/etiology , Radiotherapy/adverse effects , Tomography, X-Ray Computed , Treatment Outcome
18.
J Clin Med ; 13(6)2024 Mar 08.
Article in English | MEDLINE | ID: mdl-38541774

ABSTRACT

Background: Thoracic aortic aneurysms (TAAs) associated with Marfan syndrome (MFS) are unique in that extracellular matrix metalloproteinase inducer (EMMPRIN) levels do not behave the way they do in other cardiovascular pathologies. EMMPRIN is shed into the circulation through the secretion of extracellular vesicles. This has been demonstrated to be dependent upon the Membrane Type-1 MMP (MT1-MMP). We investigated this relationship in MFS TAA tissue and plasma to discern why unique profiles may exist. Methods: Protein targets were measured in aortic tissue and plasma from MFS patients with TAAs and were compared to healthy controls. The abundance and location of MT1-MMP was modified in aortic fibroblasts and secreted EMMPRIN was measured in conditioned culture media. Results: EMMPRIN levels were elevated in MFS TAA tissue but reduced in plasma, compared to the controls. Tissue EMMPRIN elevation did not induce MMP-3, MMP-8, or TIMP-1 expression, while MT1-MMP and TIMP-2 were elevated. MMP-2 and MMP-9 were reduced in TAA tissue but increased in plasma. In aortic fibroblasts, EMMPRIN secretion required the internalization of MT1-MMP. Conclusions: In MFS, impaired EMMPRIN secretion likely contributes to higher tissue levels, influenced by MT1-MMP cellular localization. Low EMMPRIN levels, in conjunction with other MMP analytes, distinguished MFS TAAs from controls, suggesting diagnostic potential.

19.
Vasc Endovascular Surg ; : 15385744221105357, 2022 May 26.
Article in English | MEDLINE | ID: mdl-35617123

ABSTRACT

Thoracic endovascular aortic repair (TEVAR) has reduced the morbidity and mortality associated with the treatment of thoracic aortic pathologies. However, TEVAR's use is often predicated on sufficiently large femoral access for the delivery of the endograft device. Transcaval access, or the delivery of endovascular device via the vena cava before crossing into the aorta, has been used successfully for the deployment of transcatheter aortic valves. Our institution previously reported on a case of TEVAR using transcaval access. We now report on the long-term follow-up outcome of this case. At 6 years post-surgery, computed tomography angiography (CTA) indicates stable aortic repair without any concerning findings associated with the site of transcaval access into the aorta. The patient is clinically without signs of lower extremity vascular or cardiopulmonary compromise. Overall, transcaval access for TEVAR is a promising alternative to traditional femoral artery access in highly-select patients with the appropriate anatomical and pathological indications.

20.
Vasc Endovascular Surg ; 55(7): 777-780, 2021 Oct.
Article in English | MEDLINE | ID: mdl-33866876

ABSTRACT

Failing EVAR is typically treated with open explant or conversion to fenestrated endovascular repair. Novel solutions for EVAR salvage may be required in patients unable to tolerate explant or travel to centers with custom-fenestrated capabilities. However, strategies utilizing commercially available devices are often limited by anatomic constraints such as short renal artery to endograft bifurcation length. We present a case of progressive sac expansion due to late, concomitant type Ia and type IIIa endoleaks. The patient was successfully treated by proximal extension into the visceral segment using a Cook Zenith Fenestrated device and graft relining using the Endologix AFX®2.


Subject(s)
Aortic Aneurysm, Abdominal/surgery , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis , Endoleak/surgery , Endovascular Procedures/instrumentation , Stents , Aged, 80 and over , Aortic Aneurysm, Abdominal/diagnostic imaging , Blood Vessel Prosthesis Implantation/adverse effects , Endoleak/diagnostic imaging , Endoleak/etiology , Endovascular Procedures/adverse effects , Humans , Male , Prosthesis Design , Reoperation , Treatment Outcome
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