ABSTRACT
BACKGROUND: Hybrid debranching repair of pararenal and thoracoabdominal aortic aneurysms was initially designed as a better alternative to standard open repair, addressing the limitations of endovascular repair involving the visceral aorta. We reviewed the collective outcomes of hybrid debranching repairs using extra-anatomic, open surgical debranching of the renal-mesenteric arteries, followed by endovascular aortic stenting. METHODS: Data from patients who underwent hybrid repair in 14 North American institutions during 10 years were retrospectively reviewed. Society of Vascular Surgery scores were used to assess comorbidity risk. Early and late outcomes, including mortality, morbidity, reintervention, and patency were analyzed. RESULTS: A total of 208 patients (118 male; mean age, 71±8 years old) were treated by hybrid repair with extraanatomic reconstruction of 657 renal and mesenteric arteries (mean 3.2 vessels/patient). Mean aneurysm diameter was 6.6±1.3 cm. Thoracoabdominal aortic aneurysms were identified in 163 (78%) patients and pararenal aneurysms in 45 (22%). A single-stage repair was performed in 92 (44%) patients. The iliac arteries were the most common source of inflow (n=132; 63%), and most (n=150; 72%) had 3 or more bypasses. There were 30 (14%) early deaths, ranging widely across sites (0%-21%). A Society of Vascular Surgery comorbidity score >15 was the primary predictor of early mortality (P<0.01), whereas mortality was 3% in a score ≤9. Early complications occurred in 140 (73%) patients and included respiratory complications in 45 patients (22%) and spinal cord ischemia in 22 (11%), of whom 10 (45%) fully recovered. At 5 years, survival was 61±5%, primary graft patency was 90±2%, and secondary patency was 93±2%. The most significant predictor of late mortality was renal insufficiency (P<0.0001). CONCLUSIONS: Mortality after hybrid repair and visceral debranching is highly variable by center, but strongly affected by preoperative comorbidities and the centers' experience with the technique. With excellent graft patency at 5 years, the outcomes of hybrid repair done at centers of excellence and in carefully selected patients may be comparable (or better) than traditional open or even totally endovascular approaches. However, in patients already considered as high-risk for surgery, it may not offer better outcomes.
Subject(s)
Aortic Aneurysm, Thoracic , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Aged , Aorta/surgery , Aortic Aneurysm, Thoracic/diagnostic imaging , Aortic Aneurysm, Thoracic/surgery , Blood Vessel Prosthesis/adverse effects , Blood Vessel Prosthesis Implantation/adverse effects , Endovascular Procedures/adverse effects , Humans , Male , Middle Aged , North America , Postoperative Complications/etiology , Registries , Retrospective Studies , Risk Factors , Time Factors , Treatment OutcomeABSTRACT
BACKGROUND: Transcarotid arterial revascularization (TCAR) offers a novel technique for carotid artery stenting (CAS) that provides flow reversal in the carotid artery and avoids aortic arch manipulation, thus, potentially lowering ipsilateral and contralateral periprocedural stroke rates. As a new technology, adoption may be limited by concern for learning a new technique. This study seeks to examine the number of cases needed for a surgeon to reach technical proficiency. METHODS: Retrospective analysis was performed using a prospectively collected database of all TCAR procedures performed in a tertiary health care system between 2016 and 2020. Patient demographics and anatomic characteristics were collected. Intraoperative variables and perioperative outcomes were examined. These variables were collated into groups for the first 4 procedures, procedures 5-8, and after 8. Independent Samples t test, 1-way ANOVA, and logarithmic regression were used to statistically analyze the data. RESULTS: One-hundred and eighty-seven TCARs were performed by 14 surgeons. One hundred and twenty-two (65%) were male, 59 (32%) were older than 75 years, and 83 (44%) were symptomatic. The most common indications were high-lesions in 87 patients (47%) and recurrent stenosis after CEA in 37 patients (20%). Significant differences were found between the first and second groups of 4 cases when comparing mean operative time (71 vs. 58 min; P = 0.001) and flow reversal time (10.8 vs. 7.9 min; P= 0.004). similar significant differences were found between the first and third groups of 4 cases but not between the second and third groups. There was a reduction in contrast usage and fluoroscopy time after the first 4 cases, however, this did not reach statistical significance. There was no ipsilateral perioperative strokes. One patient had a contralateral stroke on postoperative day 2 due to intracranial atherosclerosis, and there was one perioperative mortality that occurred on postoperative day 3 after discharge. CONCLUSIONS: Procedural and flow reversal times significantly shorten after 4 TCAR procedures are performed. Other metrics, such as fluoroscopy time and contrast usage, are also decreased. Complications, in general, are minimal. Proficiency in TCAR, as measured by these metrics, is met after performing only 4 procedures.
Subject(s)
Clinical Competence , Learning Curve , Vascular Surgical Procedures/education , Aged , Analysis of Variance , Female , Humans , Male , Postoperative Complications/epidemiology , Postoperative Complications/mortality , Retrospective Studies , Stroke/epidemiology , Stroke/etiology , Vascular Surgical Procedures/adverse effectsABSTRACT
OBJECTIVES: Spinal cord ischemia following thoracic endovascular aortic repair (TEVAR) is a devastating complication. This study seeks to demonstrate how a standardized protocol to prevent spinal cord ischemia affects incidence in patients undergoing TEVAR. METHODS: Using CPT codes 33880 and 33881, all TEVAR procedures performed at a single tertiary care center from January 2017 to December 2018 were examined. Patients who had concomitant ascending aortic repairs or a TEVAR for traumatic indications were excluded from analysis, leaving 130 TEVAR procedures. Comorbid conditions, procedural characteristics, extent of coverage, peri-procedural management strategies, and post-operative outcomes were collected and analyzed retrospectively. RESULTS: One hundred thirty patients undergoing TEVAR were examined for four perioperative variables: postoperative hemoglobin greater than 10 g/dL, subclavian revascularization, preoperative spinal drain placement, and somatosensory evoked potential monitoring (SSEP). All conditions were met in 46.2% (60/130) of procedures; 37.8% (28/74) in emergent/urgent cases and 61.5% (32/52) in elective cases. Of patients who required subclavian coverage, 87.1% (54/62) underwent subclavian revascularization; 70.8% (92/130) of patients received spinal drains preoperatively; 68.5% (89/130) of patients had SSEP monitoring; 73.8% (93/130) of patients obtained a postoperative hemoglobin of >10 g/dL. Out of all patients, two (1.5%) developed spinal cord ischemia. CONCLUSION: Incidence of spinal cord ischemia in our cohort was low at 1.5% (2/130). Individual and bundled interventions for the prevention of spinal cord ischemia were unable to demonstrate a statistically significant effect given the low rate. Nonetheless, we advocate for a proactive approach for the prevention of spinal cord ischemia given our experience in this complex population.
Subject(s)
Aortic Aneurysm, Thoracic , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Spinal Cord Ischemia , Aorta, Thoracic/diagnostic imaging , Aorta, Thoracic/surgery , Aortic Aneurysm, Thoracic/complications , Aortic Aneurysm, Thoracic/diagnostic imaging , Aortic Aneurysm, Thoracic/surgery , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/methods , Endovascular Procedures/adverse effects , Endovascular Procedures/methods , Humans , Retrospective Studies , Risk Factors , Spinal Cord Ischemia/diagnosis , Spinal Cord Ischemia/epidemiology , Spinal Cord Ischemia/etiology , Time Factors , Treatment OutcomeABSTRACT
OBJECTIVE: The standard surgical approach to Stanford type A aortic dissection is open repair. However, up to one in four patients will be declined surgery because of prohibitive risk. Patients who are treated nonoperatively have an unacceptably high mortality. Endovascular repair of the ascending aorta is emerging as an alternative treatment for a select group of patients. The reported rates of technical success, mortality, stroke, and reintervention have varied. The objective of the study was to systematically report outcomes for acute type A dissections repaired using an endovascular approach. METHODS: The systematic review and meta-analysis was conducted in accordance with the PRISMA (preferred reporting items for systematic reviews and meta-analyses) guidelines. We performed online literature database searches through April 2020. The demographic and procedural characteristics of the individual studies were tabulated. Data on technical success, short-term mortality, stroke, and reintervention were extracted and underwent meta-analysis using a random effects model. RESULTS: Fourteen studies with 80 cases of aortic dissection (55 acute and 25 subacute) were included in the final analysis. A wide variation was found in technique and device design across the studies. The outcomes rates were estimated at 17% (95% confidence interval [CI], 10%-26%) for mortality, 15% (95% CI, 8%-23%) for technical failure, 11% (95% CI, 6%-19%) for stroke and 18% (95% CI, 9%-31%) for reintervention. The mean Downs and Black quality assessment score was 13.9 ± 3.2. CONCLUSIONS: The technique for endovascular repair of type A aortic dissection is feasible and reproducible. The results of our meta-analysis demonstrate an acceptable safety profile for inoperable patients who otherwise would have an extremely poor prognosis. Data from clinical trials are required before the technique can be introduced into routine clinical practice.
Subject(s)
Aortic Aneurysm/surgery , Aortic Dissection/surgery , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Adult , Aged , Aged, 80 and over , Aortic Dissection/diagnostic imaging , Aortic Dissection/mortality , Aortic Aneurysm/diagnostic imaging , Aortic Aneurysm/mortality , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/mortality , Clinical Decision-Making , Endovascular Procedures/adverse effects , Endovascular Procedures/mortality , Female , Humans , Male , Middle Aged , Patient Safety , Risk Assessment , Risk Factors , Treatment OutcomeABSTRACT
Endovascular aortic aneurysm repair of complex aortic aneurysms requires incorporation of side branches using specially designed aortic stent grafts with fenestrations, directional branches, or parallel stent grafts. These techniques have been increasingly used and reported in the literature. The purpose of this document is to clarify and to update terminology, classification systems, measurement techniques, and end point definitions that are recommended for reports dealing with endovascular repair of complex abdominal and thoracoabdominal aortic aneurysms involving the renal and mesenteric arteries.
Subject(s)
Aortic Aneurysm, Abdominal/surgery , Aortic Aneurysm, Thoracic/surgery , Endovascular Procedures/methods , Publishing/standards , Terminology as Topic , Aged , Aged, 80 and over , Endovascular Procedures/instrumentation , Female , Guidelines as Topic , Humans , Male , Mesenteric Arteries/surgery , Middle Aged , Renal Artery/surgery , Societies, Medical/standards , Specialties, Surgical/standardsABSTRACT
BACKGROUND: Arterial bypass tunneling via the obturator foramen (OFB) can be performed to circumvent groin infections during lower extremity revascularization. The objective of this study is to report safety and efficacy outcomes of OFB in the setting of infected femoral pseudoaneurysms and infected prosthetic femoral bypass grafts. METHODS: A multihospital, single-entity healthcare system retrospective review was conducted for all patients who underwent OFB between January 2014 through June 2020. Any patient >18 years of age who underwent OFB in the setting of groin infection with a minimum of 30 days follow-up was included in the trial. Demographic, operative, and clinical characteristics of patients were gathered during chart review. Statistical analysis was performed using Microsoft Excel and R studio. RESULTS: Seventeen patients underwent OFB during the defined time-period. Demographic data are presented in the first table (Demographic Characteristics). Mean American Society of Anesthesiologists score was 3.25. Mean estimated blood loss was 500 mL. Mean operative time was 307 min. Mean follow-up time was 8.5 months (range 0-35 months). In total, 41.2% patients underwent fluoroscopic-guided tunneling, and, when compared to blind tunneling, showed no difference in intraoperative complications or operative time (P value 0.3). In total, 52.9% of patients required ICU admission resulting in a mean number of 0.8 ICU days. The overall mean length of stay was 16.8 days. Two major amputations were reported during follow-up. Patient mortality within 30 days was 0%. Primary patency within 30 days was 100%. Intravenous drug use was not associated with an increased number of subsequent groin wound procedures (P value 0.3). Intravenous drug use was not associated with concomitant methicillin-resistant Staphylococcus aureus infection (P value 0.3). CONCLUSION: OFB is a safe and effective surgical option in patients who are unable to undergo anatomic tunneling during lower extremity bypass. OFB is associated with favorable rates of primary patency and amputation-free survival at midterm follow-up.
Subject(s)
Aneurysm, False/surgery , Aneurysm, Infected/surgery , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis/adverse effects , Femoral Artery/surgery , Lower Extremity/blood supply , Prosthesis-Related Infections/surgery , Adult , Aged , Amputation, Surgical , Aneurysm, False/diagnosis , Aneurysm, False/microbiology , Aneurysm, False/physiopathology , Aneurysm, Infected/diagnosis , Aneurysm, Infected/microbiology , Aneurysm, Infected/physiopathology , Blood Vessel Prosthesis Implantation/instrumentation , Female , Femoral Artery/microbiology , Femoral Artery/physiopathology , Humans , Limb Salvage , Male , Middle Aged , Prosthesis-Related Infections/diagnosis , Prosthesis-Related Infections/microbiology , Prosthesis-Related Infections/physiopathology , Reoperation , Retrospective Studies , Risk Factors , Time Factors , Treatment Outcome , Vascular PatencyABSTRACT
BACKGROUND: Parallel grafting presents a viable method for treating patients with complex aortic aneurysms. The current literature is limited to mostly pararenal configurations. We examined our results in patients with SMA and/or Celiac artery involvement. METHODS: A retrospective analysis was performed for all patients undergoing parallel grafting during the period of 2014 to 2018 at a single institution. All patients had at least SMA with and/or without Celiac artery parallel grafting. RESULTS: Seventy-nine patients (65% male, median age 74) were treated with 208 parallel grafts. Median ASA score is 4. Forty-nine cases were elective, 22 urgent, and 8 emergent. Mean pre-operative aneurysm diameter was 7.1 cm (4.6-15 cm). Self-expanding covered stents were used for the renal arteries (mean 6.3mm), and balloon-expandable covered stents were used for the SMA and Celiac (mean SMA 8.6 mm, mean celiac 8.3 mm). Axillary exposure was the choice of access in 68 patients (86%). Technical success was achieved in all cases. We defined this as aneurysm sac exclusion with patent visceral stent grafts, and absent to mild gutter leaks. Mean aortic graft proximal seal achieved was 48mm. Coverage extended above the celiac artery in 75% (10% stented and 65% covered). Median contrast volume was 145ml, operative duration was 4 hours, fluoroscopy time was 56 min, and EBL was 250 ml. Perioperative mortality was 6.1%. 4.5%, and 25%, for the elective, urgent, and emergent groups, respectively. There was no incidence of spinal cord ischemia. Axillary access was complicated in 4 patients, requiring patch closure of the axillary artery. One patient developed postprocedural ESRD from a rupture and ATN despite patent renal stents. Of those patients with a patent GDA and celiac coverage, 2 required a cholecystectomy. Nine patients had a persistent gutter leak at the conclusion of the procedure. Median follow-up was 12 months. On follow-up imaging, all SMA and Celiac stents were patent. Six renal stents were occluded and 2 patients progressed to ESRD, both solitary renal periscope configurations at the index procedure. Only 4 patients had persistent gutter leaks with 2 requiring reintervention. Ninety-five percent of patients demonstrated sac regression or stabilization with a mean sac size of 6.5 cm. CONCLUSIONS: Parallel grafting presents a safe, efficacious and off the shelf alternative to conventional repair of complex aortic aneurysms involving the visceral aorta.
Subject(s)
Aortic Aneurysm/surgery , Blood Vessel Prosthesis Implantation , Celiac Artery/surgery , Endovascular Procedures , Mesenteric Artery, Superior/surgery , Renal Artery/surgery , Aged , Aortic Aneurysm/diagnostic imaging , Aortic Aneurysm/mortality , Aortic Aneurysm/physiopathology , Blood Vessel Prosthesis , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis Implantation/mortality , Celiac Artery/diagnostic imaging , Celiac Artery/physiopathology , Clinical Decision-Making , Endovascular Procedures/adverse effects , Endovascular Procedures/instrumentation , Endovascular Procedures/mortality , Female , Humans , Male , Mesenteric Artery, Superior/diagnostic imaging , Mesenteric Artery, Superior/physiopathology , Postoperative Complications/mortality , Renal Artery/diagnostic imaging , Renal Artery/physiopathology , Renal Circulation , Retrospective Studies , Risk Assessment , Risk Factors , Splanchnic Circulation , Stents , Time Factors , Treatment Outcome , Vascular PatencyABSTRACT
OBJECTIVE: Fenestrated endografting for juxtarenal and pararenal abdominal aortic aneurysms affords the ability to seal stent grafts in normal aorta at and above the renal arteries. The Zenith fenestrated graft (ZFEN; Cook Medical, Bloomington, Ind) is custom-made to surgeon specifications, subject to certain manufacturing limitations. The most common configuration in the pivotal trial and in commercial use after approval has been as a scallop for the superior mesenteric artery (SMA) and two small fenestrations for the renal arteries (configuration A). An alternative configuration to maximize the seal zone length, consisting of a large fenestration for the SMA and two small fenestrations for the renal arteries (configuration B) has been routinely adopted at our institutions to potentially prevent type IA endoleak. METHODS: The present retrospective cohort study examined 100 consecutive ZFEN grafts designed for patients at two university centers from 2012 through 2019. The proximal seal length, measured from the top of the graft to the beginning of the aneurysm, was determined from the preoperative computed tomography angiograms. Alternative configurations were evaluated to determine whether they would have provided a longer proximal seal length. RESULTS: The two most common configurations were B (n = 45) and A (n = 38). For the cases in which A had been chosen but B could have been built, 5.8 ± 1.9 mm of seal zone length was lost. For the cases in which B was chosen but A could have been built, 5.8 ± 2.8 mm of seal zone length was gained. Owing, in part, to the increased proximal seal length with configuration B, this configuration has been used more frequently in the past 4 years of the present study compared with the first four (53% vs 25%; P = .004). Of 95 patients who had completed surgery and follow-up, type IA endoleaks were observed in 12 (13%) on completion angiography, all of which had resolved on follow-up imaging without intervention. No SMA was compromised by misalignment of the large fenestration in configuration B. CONCLUSIONS: A significantly longer proximal seal length can be obtained using a ZFEN with a large fenestration for the SMA and two small fenestrations for the renal arteries. Whenever possible, surgeons should consider this configuration to maximize the proximal seal length and potentially reduce the risk of proximal endoleak. An additional advantage of this approach is that stenting of the SMA to prevent shuttering will be unnecessary or impossible, making the procedure more technically facile.
Subject(s)
Aortic Aneurysm, Abdominal/surgery , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis , Endovascular Procedures/instrumentation , Mesenteric Artery, Superior/surgery , Stents , Aortic Aneurysm, Abdominal/diagnostic imaging , Blood Vessel Prosthesis Implantation/adverse effects , Endoleak/etiology , Endovascular Procedures/adverse effects , Humans , Mesenteric Artery, Superior/diagnostic imaging , Prosthesis Design , Retrospective Studies , Risk Factors , Time Factors , Treatment Outcome , United StatesABSTRACT
OBJECTIVE: Retrograde open mesenteric stenting (ROMS) through laparotomy was introduced as an alternative to surgical bypass in patients with acute mesenteric ischemia (AMI). The purpose of this study was to evaluate the indications and outcomes of ROMS for treatment of AMI and chronic mesenteric ischemia. METHODS: We reviewed the clinical data and outcomes of all consecutive patients treated by ROMS in seven academic centers from 2001 to 2013. ROMS was performed through laparotomy with retrograde access into the target mesenteric artery and stent placement using a retrograde or antegrade approach. End points were early (<30 days) and late mortality, morbidity, patency rates, and freedom from symptom recurrence and reintervention. RESULTS: There were 54 patients, 13 male and 41 female, with a mean age of 72 ± 11 years. Indications for ROMS were AMI in 44 patients (81%) and subacute-on-chronic mesenteric ischemia with flush mesenteric occlusion in 10 patients (19%). A total of 56 target mesenteric vessels were stented, including 52 superior mesenteric arteries and 4 celiac axis lesions, with a mean treatment length of 42 ± 26 mm. Retrograde mesenteric access was used in all patients, but 16 patients also required a simultaneous antegrade brachial approach. The retrograde puncture was closed primarily in 34 patients and with patch angioplasty in 17 patients; 1 patient had manual compression. Bowel resection was needed in 29 patients (66%) with AMI because of perforation or gangrene. Technical success was achieved in all (98%) except one patient for whom ROMS failed, who was treated by bypass. Early mortality was 45% (20/44) for AMI and 10% (1/10) for subacute-on-chronic mesenteric ischemia (P = .04). Early morbidity was 73% for AMI and 50% for subacute-on-chronic mesenteric ischemia (P = .27). Patient survival for the entire cohort was 43% ± 9% at 2 years. Primary patency and secondary patency at 2 years were 76% ± 8% and 90% ± 8%, respectively. Freedom from symptom recurrence and freedom from reinterventions were 72% ± 8% and 74% ± 8% at the same interval. CONCLUSIONS: ROMS offers an alternative to bypass or percutaneous stenting in patients with AMI who require abdominal exploration and in those who have flush mesenteric occlusions and have failed to respond to or are considered unsuitable for stenting by a percutaneous approach. Despite high technical success, mortality remains elevated in patients with AMI. Patency rates and freedom from symptom recurrence and reinterventions are comparable to the results achieved with stenting using percutaneous technique.
Subject(s)
Endovascular Procedures/instrumentation , Laparotomy , Mesenteric Artery, Superior/surgery , Mesenteric Ischemia/surgery , Mesenteric Vascular Occlusion/surgery , Stents , Academic Medical Centers , Acute Disease , Aged , Aged, 80 and over , Angiography , Chronic Disease , Disease-Free Survival , Endovascular Procedures/adverse effects , Endovascular Procedures/methods , Female , Humans , Kaplan-Meier Estimate , Laparotomy/adverse effects , Laparotomy/mortality , Male , Mesenteric Artery, Superior/diagnostic imaging , Mesenteric Artery, Superior/physiopathology , Mesenteric Ischemia/diagnostic imaging , Mesenteric Ischemia/mortality , Mesenteric Ischemia/physiopathology , Mesenteric Vascular Occlusion/diagnostic imaging , Mesenteric Vascular Occlusion/mortality , Mesenteric Vascular Occlusion/physiopathology , Middle Aged , Postoperative Complications/mortality , Postoperative Complications/therapy , Retreatment , Retrospective Studies , Risk Factors , Splanchnic Circulation , Time Factors , Treatment Outcome , United States , Vascular PatencyABSTRACT
Chimney endovascular aneurysm repair provides an endovascular treatment for complex aortic aneurysms. However, type I gutter endoleaks can complicate this approach and prevent full aneurysm exclusion. Treatment of these leaks can be challenging. We report successful embolization of a type I gutter endoleak after (chimney endovascular aneurysm repair) via a transcaval approach.
Subject(s)
Aortic Aneurysm, Abdominal/surgery , Blood Vessel Prosthesis Implantation/adverse effects , Embolization, Therapeutic/methods , Endoleak/therapy , Endovascular Procedures/adverse effects , Vena Cava, Inferior , Aged , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortography/methods , Blood Vessel Prosthesis Implantation/instrumentation , Computed Tomography Angiography , Endoleak/diagnostic imaging , Endoleak/etiology , Endovascular Procedures/instrumentation , Humans , Male , Phlebography/methods , Retreatment , Treatment Outcome , Vena Cava, Inferior/diagnostic imagingABSTRACT
BACKGROUND: To describe a large single-institutional experience in managing challenging access situations during endovascular aneurysm repair (EVAR). METHODS: Data from all patients undergoing EVAR at a tertiary academic medical center between 2009 and 2013 were collected retrospectively, including demographics, size of iliac arteries, type of device used, approach to managing difficult access (DA), and outcomes. The median follow-up was 38 months. DA was defined as iliac arteries with a diameter of less than 7 mm bilaterally. Fenestrated and snorkel repairs were excluded. RESULTS: Of 400 EVARs performed during the study period, 191 (48%) were done in patients with DA. Of the DA patients, 35 (18.3%) underwent 42 adjuncts before the introduction of the main body device: including 15 dilators, 11 balloon angioplasties, 9 aortouniiliac devices, 3 SoloPath sheaths, 1 retroperitoneal cutdown, and 3 iliac stents. In another 29 patients, iliac stents were used to correct stenoses or kinks in the limbs after EVAR devices were deployed. The average diameter of the iliac artery used to deliver main body component was 4.6 mm in the group of patients requiring adjuncts and 5.4 mm in the remainder of the patients with small iliac arteries (P = 0.008). The median size of the main body device was 28 mm. Two cases were aborted due to inability to deliver the device. Other complications included 7 (3.6%) iliac ruptures, 3 (1.6%) instances of limb ischemia, and 5 (2.6%) patients needed early reoperation (within 30 days). Two patients (1%) had type I endoleaks at the conclusion of EVAR. During follow-up, 12 (6.3%) patients required EVAR revisions. Seven patients (3.6%) had limb thrombosis which occurred only in patients who did not have adjective procedures during the initial EVAR. Limb thrombosis and rate of revisions in patients with DA were not significantly different from the rates observed in non-DA patients. Perioperative mortality after elective repairs was 1.6% in DA patients and 0% in non-DA patients (P = 0.12). CONCLUSIONS: EVAR can be successfully performed in patients with bilateral small iliac arteries. Adjunctive procedures might increase the technical success rate of EVAR in these patients and should definitely be considered in patients with iliac arteries less than 5 mm in diameter. Next generation and "low-profile" devices might minimize the need for adjunctive procedures and facilitate EVAR in these patients.
Subject(s)
Aortic Aneurysm, Abdominal/surgery , Blood Vessel Prosthesis Implantation/adverse effects , Endovascular Procedures/adverse effects , Iliac Artery/surgery , Postoperative Complications/etiology , Aged , Aged, 80 and over , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/mortality , Blood Vessel Prosthesis , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis Implantation/mortality , Endovascular Procedures/instrumentation , Endovascular Procedures/mortality , Female , Hospitals, University , Humans , Iliac Artery/diagnostic imaging , Male , Middle Aged , Philadelphia , Postoperative Complications/diagnostic imaging , Postoperative Complications/mortality , Postoperative Complications/surgery , Prosthesis Design , Reoperation , Retrospective Studies , Risk Factors , Stents , Tertiary Care Centers , Time Factors , Treatment OutcomeABSTRACT
UNLABELLED: Alternative treatment strategies for claudication are needed and cell-based therapies designed to induce angiogenesis are promising. The purpose of this report was to conduct a Phase I safety, dose-escalating, non-randomized, open-label study of autologous, fully differentiated venous endothelial and smooth muscle cells called MultiGeneAngio (MGA) for claudication due to peripheral artery disease. Twelve subjects, at two centers, received a single intra-arterial infusion of a suspension of equal amounts of transduced autologous venous smooth muscle cells expressing vascular endothelial growth factor (VEGF165) and endothelial cells expressing angiopoietin-1 (Ang-1) (Cohort 1: 1 × 10(7), Cohort 2: 2 × 10(7), Cohort 3: 5 × 10(7), Cohort 4: 7 × 10(7)). The treatment was given unblinded and in the more symptomatic lower extremity. Transduced cells were tested for in vitro doubling time, telomerase activity, and gene expression. The main outcomes were clinical safety and tolerability. Other safety measures included ankle-brachial index (ABI) and walking time on a treadmill. All subjects were male (mean age 60 ± 5 years) including 25% with diabetes mellitus. At 1-year follow-up, there was one serious adverse event possibly related to MGA. Safety endpoints including VEGF and Ang-1 plasma protein levels were within normal ranges in all subjects. The mean maximal walking time increased from baseline to 1 year and the index limb ABI was unchanged, indicating no safety concerns. MGA, an autologous, transduced, cell-based therapy was well tolerated and safe in this Phase I study. Further evaluation is warranted in randomized human studies. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00390767.
Subject(s)
Angiogenic Proteins/biosynthesis , Cell Transplantation/methods , Endothelial Cells/transplantation , Genetic Therapy/methods , Intermittent Claudication/surgery , Myocytes, Smooth Muscle/transplantation , Neovascularization, Physiologic , Peripheral Arterial Disease/surgery , Aged , Angiogenic Proteins/genetics , Angiopoietin-1/biosynthesis , Angiopoietin-1/genetics , Ankle Brachial Index , Cell Proliferation , Cells, Cultured , Endothelial Cells/metabolism , Exercise Test , Exercise Tolerance , Humans , Intermittent Claudication/diagnosis , Intermittent Claudication/genetics , Intermittent Claudication/metabolism , Intermittent Claudication/physiopathology , Male , Michigan , Middle Aged , Myocytes, Smooth Muscle/metabolism , Pennsylvania , Peripheral Arterial Disease/diagnosis , Peripheral Arterial Disease/genetics , Peripheral Arterial Disease/metabolism , Peripheral Arterial Disease/physiopathology , Recovery of Function , Telomerase/metabolism , Time Factors , Transduction, Genetic , Treatment Outcome , Vascular Endothelial Growth Factor A/biosynthesis , Vascular Endothelial Growth Factor A/geneticsABSTRACT
OBJECTIVE: Venous thromboembolism (VTE) is a potentially preventable complication following surgery. There is variation with regard to the most effective mode of prophylaxis. We sought to determine if an aggressive approach to VTE prophylaxis would reduce VTE rates on the inpatient vascular surgical service. METHODS: Vascular inpatients from a single institution from July 2010 to March 2013 were included in the analysis. A protocol for VTE prophylaxis was implemented on the inpatient vascular surgical service in November 2011. This included subcutaneous (SQ) heparin initiation within 24 h of admission unless deemed inappropriate by the attending, as well as intermittent compression devices (ICD) and compression stockings (CS). The rate of VTE was compared prior to and following the intervention. Patients were compared using AHRQ comorbidity categories, APR-DRG severity of illness, insurance status, and principle procedure. T-tests were used to compare continuous variables and chi-square analysis used to compare categorical variables. RESULTS: There were 1483 vascular patients in the pre-intervention group and 1652 patients in the post-intervention group. The rate of pharmacologic prophylaxis was 52.57% pre-intervention compared to 69.33% post-intervention (p < 0.001). The rate of pharmacologic or mechanical prophylaxis was 91.76% pre-intervention compared to 93.10% post-intervention (p = 0.54). The overall rate of VTE prior to the intervention was 1.49% compared to after intervention which was 0.38% (p = 0.033). The DVT rate prior to intervention was 1.09% vs 0.189% after intervention (p = 0.0214). The rate of pulmonary embolism trended towards a significant reduction with the intervention (0.681% vs 0.189%, p = 0.095). There were no statistically significant differences in patient groups based on gender, comorbidity category, severity of illness, or insurance type. CONCLUSIONS: The overall rate of VTE was reduced by 75% after the initiation of a standard protocol for pharmacologic VTE prophylaxis. These findings justify an aggressive approach to VTE prophylaxis in vascular surgery patients.
Subject(s)
Anticoagulants/administration & dosage , Heparin/administration & dosage , Intermittent Pneumatic Compression Devices , Pulmonary Embolism/prevention & control , Stockings, Compression , Vascular Surgical Procedures/adverse effects , Venous Thromboembolism/prevention & control , Venous Thrombosis/prevention & control , Aged , Aged, 80 and over , Anticoagulants/adverse effects , Chi-Square Distribution , Female , Heparin/adverse effects , Humans , Injections, Subcutaneous , Male , Middle Aged , Philadelphia , Pulmonary Embolism/diagnostic imaging , Pulmonary Embolism/etiology , Risk Factors , Time Factors , Treatment Outcome , Venous Thromboembolism/diagnostic imaging , Venous Thromboembolism/etiology , Venous Thrombosis/diagnostic imaging , Venous Thrombosis/etiologyABSTRACT
OBJECTIVE: Growing evidence suggests that peak wall stress (PWS) derived from finite element analysis (FEA) of abdominal aortic aneurysms (AAAs) predicts clinical outcomes better than diameter alone. Prior models assume uniform wall thickness (UWT). We hypothesize that the inclusion of locally variable wall thickness (VWT) into FEA of AAAs will improve its ability to predict clinical outcomes. METHODS: Patients with AAAs (n = 26) undergoing radiologic surveillance were identified. Custom MATLAB algorithms generated UWT and VWT aortic geometries from computed tomography angiography images, which were subsequently loaded with systolic blood pressure using FEA. PWS and aneurysm expansion (as a proxy for rupture risk and the need for repair) were examined. RESULTS: The average radiologic follow-up time was 22.0 ± 13.6 months and the average aneurysm expansion rate was 2.8 ± 1.7 mm/y. PWS in VWT models significantly differed from PWS in UWT models (238 ± 68 vs 212 ± 73 kPa; P = .025). In our sample, initial aortic diameter was not found to be correlated with aneurysm expansion (r = 0.26; P = .19). A stronger correlation was found between aneurysm expansion and PWS derived from VWT models compared with PWS from UWT models (r = 0.86 vs r = 0.58; P = .032 by Fisher r to Z transformation). CONCLUSIONS: The inclusion of locally VWT significantly improved the correlation between PWS and aneurysm expansion. Aortic wall thickness should be incorporated into future FEA models to accurately predict clinical outcomes.
Subject(s)
Aorta, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortography/methods , Computer Simulation , Models, Cardiovascular , Tomography, X-Ray Computed , Aged , Aged, 80 and over , Aorta, Abdominal/physiopathology , Aortic Aneurysm, Abdominal/physiopathology , Biomechanical Phenomena , Disease Progression , Female , Finite Element Analysis , Hemodynamics , Humans , Male , Middle Aged , Predictive Value of Tests , Prognosis , Radiographic Image Interpretation, Computer-Assisted , Retrospective Studies , Stress, Mechanical , Time FactorsABSTRACT
BACKGROUND: Length of stay (LOS) is used as a quality metric to reduce cost and improve value of delivery of care. We sought to analyze trends in endovascular aortic aneurysm repair (EVAR) LOS at a tertiary academic institution over the last decade. METHODS: A retrospective review of prospectively collected data was performed. Infrarenal EVARs from 2001 to 2013 were divided into 3 groups: group I (2001-2004), EVARs were performed as part of clinical trials; group II (2005-2008), EVARs were referred to a tertiary referral center with the most experience with EVAR; group III (2009-2013), EVARs were referred to academic institutions in the presence of severe patient comorbidities. Trends in LOS and correlation with severity of illness (SOI) as based on All Patient Refined Diagnosis Related Groups and admission and/or disposition status were analyzed. LOS index (LOSI) at our institution was then compared with University HealthSystem Consortium (UHC) Hospitals over the past 3 years. RESULTS: A total of 1,265 EVARs were performed during this time period: 325 in group I, 547 in group II, and 393 in group III. The median LOS was 4 days (inter quartile range [IQR], 2-6) vs. 3 days (IQR, 2-5) ± 0.28 vs. 4 days (IQR, 3-7), respectively (P < 0.01). Although moderate SOI was fairly constant over time (P = 0.66), major and/or extreme SOI constituted a greater proportion of patients in group I, was reduced in group II, and was again increased in group III, P < 0.01. The complication rate paralleled this pattern (group I, 15.2%; group II, 8.6%; group III, 10.4%; P = 0.02). The percentage of patients discharged to nursing home and/or rehab was 5.7% in group I, 8.2% in group II, 11.5% in group III (P = 0.03). Cases that were performed urgently and/or emergently increased over time: 11.6% in group I, 14.9% in group II, 21.6% in group III (P = 0.01). The risk-adjusted LOSI at our institution was significantly greater (1.25) when compared with UHC hospitals (0.75). CONCLUSIONS: Our study suggests a relationship between time period of EVAR, SOI, complications, admission status, and LOS. Attention to these trends could be used to decrease LOS in an increasingly complex patient population.
Subject(s)
Aortic Aneurysm, Abdominal/surgery , Endovascular Procedures , Length of Stay , Aged , Aged, 80 and over , Aortic Aneurysm, Abdominal/complications , Aortic Aneurysm, Abdominal/mortality , Female , Hospitals, University , Humans , Male , Middle Aged , Retrospective Studies , Severity of Illness Index , Time Factors , Treatment OutcomeSubject(s)
Aortic Aneurysm, Abdominal/surgery , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Aortic Aneurysm, Abdominal/diagnostic imaging , Blood Vessel Prosthesis , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/instrumentation , Endoleak/etiology , Endovascular Procedures/adverse effects , Endovascular Procedures/instrumentation , Evidence-Based Medicine , Humans , Registries , Risk Assessment , Risk Factors , Stents , Treatment OutcomeABSTRACT
OBJECTIVE: The objective of this study was to evaluate postapproval outcomes of patients with juxtarenal aortic aneurysms treated with the Zenith fenestrated endovascular graft (Cook Inc, Bloomington, Ind). METHODS: We reviewed clinical data of consecutive patients treated with the Zenith fenestrated endovascular graft in the United States at seven institutions with early commercial access from July 2012 to December 2012. Clinical outcomes and compliance to anatomic guidelines were compared with results of the U.S. fenestrated trial (USFT). RESULTS: Fifty-seven patients were treated. There were significantly more (P < .05) patients with coronary artery disease, myocardial infarction, and preoperative renal insufficiency than in the USFT. Thirty-six patients (63.2%) did not meet the USFT anatomic criteria of a >4-mm infrarenal neck, and there were significantly more mesenteric stents (13 vs 0; P < .05) used in this group than in the USFT, reflecting the higher anatomic complexity of these patients. The total operative time was 250.2 ± 14.8 minutes, the fluoroscopy time was 68.9 ± 4.47 minutes, and the average volume of contrast material was 108.6 ± 5.6 mL. Technical success was 100% in regard to aneurysm exclusion, although the left renal fenestration was not able to be aligned in two patients, and one patient had a kinked renal stent that was successfully restented. During this time period, there were a total of 10 endoleaks, of which two were type III and eight were type II. CONCLUSIONS: Despite higher rates of comorbidities and more challenging anatomy, early 30-day outcomes of juxtarenal aortic aneurysms treated postapproval with the Zenith fenestrated endovascular graft compare well with USFT data. Future studies are needed to assess durability of this treatment modality as the technology diffuses and data mature.
Subject(s)
Aortic Aneurysm, Abdominal/surgery , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis , Endovascular Procedures/instrumentation , Aged , Aortic Aneurysm, Abdominal/diagnosis , Blood Vessel Prosthesis Implantation/adverse effects , Comorbidity , Device Approval , Endoleak/etiology , Endovascular Procedures/adverse effects , Female , Humans , Male , Operative Time , Patient Selection , Prosthesis Design , Retrospective Studies , Risk Factors , Time Factors , Treatment Outcome , United StatesABSTRACT
OBJECTIVE: To explore the incidence, predictors, and outcomes of hemodynamic instability (HI) following carotid angioplasty and stenting (CAS). METHODS: We retrospectively evaluated data on 257 CAS procedures performed in 245 patients from 2002 to 2011 at a single institution. The presence of periprocedural HI, as defined by hypertension (systolic blood pressure >160 mm Hg), hypotension (systolic blood pressure <90 mm Hg), and/or bradycardia (heart rate <60 beats per minute), was recorded. Clinically significant HI (CS-HI) was defined as periprocedural HI lasting greater than 1 hour in total duration. Logistic regression was used to analyze the role of multiple demographic, clinical, and procedural variables. RESULTS: Mean age was 70.9 ± 9.9 years (67% male). HI occurred following 84% (n = 216) of procedures. The incidence of hypertension, hypotension, and bradycardia was 54%, 31%, and 60%, respectively. Sixty-three percent of cases involved CS-HI. Recent stroke was an independent risk factor for the development of CS-HI (odds ratio, 5.24; confidence interval, 1.28-21.51; P = .02), whereas baseline chronic obstructive pulmonary disease was protective against CS-HI (odds ratio, 0.34; confidence interval, 0.15-0.80; P = .01). Patients with CS-HI were more likely to experience periprocedural stroke compared to other patients (8% vs 1%; P = .03). There were no significant differences in the incidence of mortality or other major complications between those with and without CS-HI. CONCLUSIONS: HI represents a common occurrence following CAS. While the presence of periprocedural HI alone did not portend a worse clinical outcome, CS-HI was associated with increased risk of stroke. Expeditious intervention to prevent and manage CS-HI is of critical importance in order to minimize adverse clinical events following CAS.
Subject(s)
Angioplasty/instrumentation , Carotid Artery Diseases/therapy , Hemodynamics , Postoperative Complications/epidemiology , Postoperative Complications/physiopathology , Stents , Aged , Angioplasty/adverse effects , Angioplasty/mortality , Bradycardia/epidemiology , Bradycardia/physiopathology , Carotid Artery Diseases/diagnosis , Carotid Artery Diseases/mortality , Carotid Artery Diseases/physiopathology , Chi-Square Distribution , Female , Humans , Hypertension/epidemiology , Hypertension/physiopathology , Hypotension/epidemiology , Hypotension/physiopathology , Incidence , Logistic Models , Male , Middle Aged , Multivariate Analysis , Odds Ratio , Philadelphia/epidemiology , Postoperative Complications/mortality , Retrospective Studies , Risk Factors , Stroke/epidemiology , Stroke/physiopathology , Time Factors , Treatment OutcomeABSTRACT
OBJECTIVE: Many patients treated with endovascular aortic repair (EVAR) have a concomitant suprarenal abdominal aortic aneurysm (sAAA). The natural history of these sAAAs and whether they require intervention after EVAR is unknown. METHODS: We identified 470 patients from the M2S database (M2S Inc, West Lebanon, NH) as having an infrarenal AAA (iAAA) with a concomitant sAAA (diameter, 2.9-4.7 cm). The analysis included 217 patients with preoperative computed tomography angiography and follow-up imaging of ≥12 months. Patients who did not undergo EVAR (n = 65) served as a control. Patients with EVAR were subdivided into 90 with suprarenal fixation (SR) and 62 with infrarenal fixation (IR). Standard measurements from the M2S images were extracted, and growth rates were calculated for different abdominal aortic segments. RESULTS: The average follow-up was 33.0 ± 18.8 months. The average sAAA initial size and growth rate were 34.6 ± 3.0 and 0.6 ± 1.1 mm/y for SR, 34.0 ± 3.3 and 0.6 ± 1.3 mm/y for IR, and 36.6 ± 3.4 and 1.2 ± 1.5 mm/y for controls (SR vs IR, P > .05; SR or IR vs control, P < .05). After EVAR, two of 152 (1.3%) sAAAs grew to ≥ 50 mm, which was not statistically different from four of 65 (6.2%) in the control group (P = .07). At 48 months, the Kaplan-Meier freedom from sAAA growth to ≥ 50 mm was 99.3% for patients undergoing EVAR and 95.2% for controls (P = .061). Patients with starting sAAAs sized ≥ 40 mm had a higher growth rate (1.4 ± 2.1 mm/y) and frequency of growth to ≥50 mm (14.3%) than patients with starting sAAAs sized <40 mm (0.7 ± 1.2 mm/y and 1.5%; P < .05). CONCLUSIONS: Isolated treatment of iAAAs via EVAR with a concomitant sAAA is acceptable because endografts with or without SR do not affect sAAA growth rates. Routine EVAR follow-up is sufficient for sAAAs of <40 mm, and more intensive follow-up should be considered for sAAAs of 40 to 50 mm. For sAAAs approaching 50 mm, an endograft with IR should be considered in case sAAA repair is required in the future.
Subject(s)
Aortic Aneurysm, Abdominal/surgery , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortography/methods , Blood Vessel Prosthesis , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/instrumentation , Endovascular Procedures/adverse effects , Endovascular Procedures/instrumentation , Humans , Kaplan-Meier Estimate , New Hampshire , Predictive Value of Tests , Prosthesis Design , Time Factors , Tomography, X-Ray Computed , Treatment OutcomeABSTRACT
OBJECTIVE: The management of infected aortic endografts is a challenging endeavor. Treatment of this problem has not been well defined as it is fairly uncommon. However, the incidence is increasing. This study examines the results of treatment at a single center for this morbid process. METHODS: A retrospective review was performed of patients treated for infected abdominal or thoracic endograft infection following previous abdominal or thoracic endovascular aneurysm repair. Data was reviewed for patient demographics, details of initial endograft implantation, presentation and timeline of subsequent infection, management of infected grafts, and outcomes during follow-up. RESULTS: Overall, 18 patients were treated for infected endografts (thoracic: six, abdominal:12). Three patients were treated between 2000 and 2006, corresponding to a 0.6% institutional incidence of endograft infection (3/473). There were no transfers for infected endografts from outside institutions. From 2006 to 2011, 15 patients underwent treatment. Six were institutional cases of infections (6/945, 0.6% infection rate), however, there was an increase in transfers (n = 9). Median time to presentation with infection from endograft implant was 90 days, with over one-half (61%) presenting within the first 3 months. Tissue and/or blood cultures were positive in 12/16 growing Escherichia coli (n = 1), group A streptococcus (n = 3), methicillin-resistant Staphylococcus aureus (n = 3), or polymicrobial infections (n = 7). The other four patients were culture negative with computed tomography evidence of gas surrounding the endograft and clinical sepsis. Ten patients (abdominal: eight, thoracic: two) were treated with endograft explantation. The remaining eight patients were considered too high-risk for explant or refused open surgery and were therefore managed conservatively without explant (abdominal: four, thoracic: four). At a mean follow-up of 24.7 months, aneurysm-related mortality was 38.9% (n = 7) and was higher for patients presenting with aortoenteric or aortobronchial fistulas (n = 6/10, 60%) (P = .04) and for thoracic stent infections (n = 5/6; 83%) (P = .03). The only survivor of a thoracic infection was managed surgically. Overall survival for patients with abdominal endografts (n = 12) was similar between the eight patients managed surgically (n = 6/8; 75%) and the four selected for medical management (n = 4/4; 100%) (P = .39). All survivors remain on long-term suppressive antibiotics. Two additional patients died of unrelated causes during follow-up. CONCLUSIONS: Endograft infection is a rare but increasing complication after abdominal or thoracic endovascular aneurysm repair, which carries significant associated morbidity and mortality. Most endograft infections occurred in proximity to other types of infection, suggesting that bacterial seeding of the endograft was the source. Aortoenteric and aortobronchial fistulas are common presentations, which portend a significantly worse prognosis. Thoracic endograft infections, which have the highest rate of fistulization, have the worst outcomes. Surgical excision continues to be standard of care but conservative management with intravenous antibiotics may be of benefit in certain patients with abdominal endograft infections.