Objective: The aim of this study was to evaluate the use of clopidogrel at the time of carotid endarterectomy (CEA) and its association with postoperative complications. Methods: Single-institution, retrospective review of a prospective database. Results: From 2010 to 2017, CEA was performed in 1066 consecutive patients (median age, 73 years; 66% men). The indications for operation included $70% asymptomatic stenosis (458; 43%), prior stroke (314; 29%), and transient cerebral or retinal ischemia (294; 28%). At the time of operation, 509 (48%) patients were taking aspirin alone, 441 (41%) were taking clopidogrel (374 in combination with aspirin, 67 as sole therapy), 83 (8%) were on no documented antiplatelet medication, and 33 (3%) were taking warfarin (with therapeutic international normalized ratio). The likelihood of clopidogrel use at the time of operation was higher for patients with a history of symptomatic carotid disease ( P = .002). Over the study period, clopidogrel use increased from 31.9% in 2010 to 56.8% in 2017, which corresponds to an 11% (95% confidence interval, 6%-15%) increase annually. Postoperative strokes occurred in 15 patients (overall incidence, 1.4%), the majority of which were minor (12/15; 80%). Six strokes occurred in patients taking aspirin alone (6/509; 1.2%), two in patients on clopidogrel and aspirin (2/441; 0.5%), two in patients taking clopidogrel alone (2/67; 2.9%), three in patients on no documented antiplatelet medication (3/83; 3.6%), and two in those taking warfarin (one of which was secondary to a fatal intracranial hemorrhage within 30 days of discharge [2/33; 6.1%]). The 30-day mortality rate was 0.03% (3/1066); the risk for the combined endpoint of any stroke, death, or myocardial infarction (MI) was 2.3% (25/1066), and the risk for major stroke, death, or MI was 1.2%. There was no apparent association between clopidogrel use and the incidence of postoperative bleeding ( P = .59) or any other postoperative complication (stroke, death, MI, cranial nerve injury; P = .15). Conclusions: Clopidogrel use in our CEA practice has increased over time and has not been associated with an increased risk of postoperative complications, including bleeding. These data suggest that clopidogrel should not be discontinued prior to CEA and should be considered as part of 'optimal medical therapy' in patients undergoing CEA.
PURPOSE:To report the safety and effectiveness outcomes through 2 years of the BioMimics 3D Vascular Stent System in the treatment of symptomatic patients with atherosclerotic femoropopliteal disease.MATERIALS AND METHODS:The tubular, nitinol BioMimics 3D stent, which was designed to impart a helical shape to the arterial segment, was implanted in 271 patients (mean age 68.4±9.5 years; 180 men) with de novo femoropopliteal lesions enrolled at 43 investigational sites [31 US (n=162), 6 German (n=78), and 6 Japanese (n=31)] in the prospective, single-arm MIMICS-2 investigational device exemption trial (ClinicalTrials.gov identifier NCT02400905) between June 2015 and October 2016. Mean lesion length was 81.2±38.4 mm, 30.0% of patients had total occlusions, and 45.9% had moderate to severe calcification. Primary safety and effectiveness endpoints were compared at 1 year with prespecified objective performance goals (OPGs) set by the VIVA Physicians organization. Outcomes through 2 years are reported.RESULTS:The primary effectiveness endpoint of 12-month primary stent patency was met by 182 of 249 patients (73.1%, 95% CI 67.3% to 78.2%), exceeding the OPG of 66%. The primary safety endpoint of 30-day freedom from major adverse events (MAEs) was met in 268 of 269 patients (99.6%, 95% CI 97.7% to 100%), exceeding the OPG of 88%. Kaplan-Meier estimates of freedom from loss of primary patency were 83.1% at 12 months and 70.2% at 24 months, freedom from MAEs estimates were 86.9% at 12 months and 79.2% at 24 months, and freedom from clinically-driven target lesion revascularization estimates were 88.0% at 12 months and 83.0% at 24 months. At 24 months, 88.2% of patients showed improvement of ≥1 Rutherford category; the ankle-brachial index was >0.9 for 64.4% vs 11.3% at baseline. There were no cases of stent fracture.CONCLUSION:Through 24 months, the BioMimics 3D Vascular Stent System provided safe and effective treatment for femoropopliteal lesions in patients with symptomatic peripheral artery disease.
Peripheral artery disease (PAD) is estimated to affect approximately 8.5 million individuals in the US above the age of 40, and is associated with significant morbidity, mortality, and impairment. Despite the significant adverse limb and cardiovascular (CV) outcomes seen in patients with PAD, there is typically less attention paid to risk factor modification relative to other atherosclerotic diseases such as coronary artery disease (CAD) or stroke. In the current literature, statins have been shown to reduce mortality, major adverse CV events, major adverse limb events, and improve symptomatic outcomes in patients with PAD. In addition, proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors are emerging as an additional lipid-lowering therapy for patients with PAD. However, despite current guideline recommendations based on growing evidence, patients with PAD are consistently undertreated with lipid-lowering therapies. We provide an extensive literature review and evidence-based recommendations for the use of statins and PCSK9 inhibitors in patients with PAD.
Background: The objective of this study was to compared outcomes of patients with aortoiliac occlusive disease (AIOD), limited to the common iliac artery, who underwent either aortoiliac thromboendarterectomy (AIE) or aortobiiliac bypass grafting (ABIB). Methods: A single-center, retrospective analysis of consecutive patients with AIOD who underwent either AIE or ABIB between 2010 and 2019 from a prospective database. Patients with disease extending to the external iliac or common femoral arteries were excluded. Data collected included demographics, cardiovascular risk factors, indication for surgery, preoperative and postoperative ankle brachial indexes (ABIs), estimated blood loss, major adverse events (MAEs), and long-term patency. The study end point was clinical success, defined as improvement in ABIs with resolution of symptoms. MAEs included return to the operating room for any reason, postoperative myocardial infarction, stroke, pneumonia, or venous thromboembolism. Results: Thirty-three patients, who met inclusion criteria, underwent repair for AIOD (AIE: 13; ABIB: 20) at our institution during this time. In both groups, there were more women than men (AIE: 11, ABIB: 10) with a mean age of 55 +/- 7 years and 58 +/- 6 years in the AIE and ABIB group, respectively. Indication for surgery included disabling claudication in 19 patients, ischemic rest pain in 13 patients, and tissue loss in one patient. No difference in cardiovascular risk factors or AIOD severity was noted between groups. Patients in the AIE group had slightly higher body mass index (30 +/- 5 vs. 26 +/- 6, P = 0.06). Two patients in each group required concomitant renal/mesenteric artery endarterectomy. One patient in the AIE group required bilateral femoral artery exposure and external iliac thrombectomy. MAEs (4 vs. 0) were higher in the ABIB group including, pneumonia in one patient, myocardial infarction in another, return to the operating room for evacuation of hematoma in the third and bypass graft thrombectomy with lower extremity angiography in the fourth patient. There were no differences in the intensive care unit or hospital length of stay between groups. Patients in both groups achieved return of normal ABI and complete resolution of their symptoms. At mean follow-up time of 43.4 +/- 25.2 and 52.9 +/- 35.4 months in the AIE and ABIB group, respectively, there was no symptomatic recurrence or need for reintervention while two patients in the ABIB group died of non-aortic-related issues. Conclusions: Both procedures were safe, effective, and conferred high long-term primary patency with no need for reintervention in patients with AIOD limited to the common iliac arteries.
OBJECTIVE:To describe our technique, evaluate access related complications and factors contributing to adverse outcomes in patients undergoing retroperitoneal anterior lumbar interbody fusion (ALIF). METHODS:We conducted a retrospective analysis of prospectively collected data on patients undergoing ALIF at our institution from January 2008 to December 2017. Access was performed by a vascular surgeon who remained present for the duration of the case. Data collected included patients' demographics, comorbidities, exposure related complications and ileus. Study end points included major adverse events and minor complications. Major adverse events included any vascular injuries requiring repair, bowel and ureter injuries, postoperative bleeding requiring reoperation, myocardial infarction, stroke, venous thromboembolism (pulmonary embolism/deep venous thrombosis), wound dehiscence, and death. Minor complications included postoperative paralytic ileus, urinary tract infections, and surgical site infections. The incidence of incisional hernia was also evaluated. RESULTS:During this period, 1178 patients (514 males and 664 females; mean age, 54.1 ± 13.8 years) underwent a total of 2352 levels ALIF at our institution (single level, 422 patients; 2 levels, 450; 3 levels, 205; 4 levels, 98; 5 levels, 6; 6 levels, 1; and 7 levels, 1). The median estimated blood loss was 25 mL (interquartile range, 25-50). There were 57 exposure-related complications (4.8%), including vascular injuries (venous, 13; arterial, 4) in 17 patients (1.4%), bowel injuries in three patients (serosa tear in two and arterial embolization with subsequent bowel ischemia in one). Eleven of the 13 venous injuries (84.6%) occurred while exposing the L4 to L5 lumbar level. Two of the four patients with arterial injuries developed acute limb ischemia requiring embolectomy. One embolized to the superior mesenteric artery and underwent bowel resection. Twenty patients (1.7%) developed venous thromboembolism, two of whom had sustained left iliac vein injury during exposure. Sixteen patients (1.4%) developed a retroperitoneal hematoma/seroma with nine requiring evacuation in the operating room. Thirty-six patients (3.1%) developed postoperative ileus, defined as an inability to tolerate diet on postoperative day 3. Four patients (0.4%) had a postoperative myocardial infarction, and two had a stroke and two (0.17%) died within the first 30 postoperative days. Thirty-one patients developed incisional complications, including surgical site infection in 24 and incisional hernia in 7. CONCLUSIONS:Our findings suggest that ALIF exposure can be performed safely with a relatively low overall complication rate. The majority of vascular injuries associated with this procedure are venous in nature, occurring predominantly while exposing the L4 to L5 level and can be safely addressed by an experienced vascular team.
Patients undergoing carotid endarterectomy (CEA) are frequently discharged on the first postoperative day, barring unforeseen complications. This study aimed to evaluate the reasons for patients with increased length of stay (LOS) in a large community hospital setting. All patients having CEA were identified from a prospective database from 2010 to 2017. Variables were captured from retrospective review of this database, including patient demographics, operative measures, and postoperative outcomes. Patients were grouped into those with standard LOS (1 day) and prolonged LOS (>1 day). Univariate and multivariable analyses were performed to identify characteristics associated with increased LOS. There were 875 patients included in our analysis; 39.8% had CEA performed for symptomatic disease. Overall median LOS was 1 day (range, 1-28 days); 30.1% of patients had an increased postoperative LOS with a median of 2 days (2-28 days). The percentage of patients who were admitted before surgery for >1 day was 4.3% and 20.2% in the standard LOS and prolonged LOS groups, respectively. Age, sex, symptomatic disease, aspirin use, regional anesthesia, and sustaining a major complication (transient ischemic attack or stroke, myocardial infarction, pulmonary complication, return to operating room, renal failure) were associated with increased LOS on univariate analysis (Table). Unplanned return to operating room was the most common major complication (standard LOS, 0.16%; prolonged LOS, 4.18%; P < .001). On multivariate analysis, major complication, symptomatic disease, and increased operative time had the greatest association with LOS >1 day. Aspirin use and regional anesthesia reduced risk of increased LOS. Prolonged LOS was identified in about a third of patients undergoing CEA. Symptomatic disease, increased operative time, and having a major postoperative complication were most likely to increase LOS, whereas antiplatelet medication use and regional anesthesia might reduce the risk of increased LOS. Further studies are needed to confirm avoidance of major complication, regional anesthesia, and antiplatelet use as potentially modifiable factors to reduce LOS.TableFactors associated with increased length of stay after CEAUnivariate analysisZero-truncated poisson regressionNo (N = 612)Yes (N = 263)P valueIRRLCLUCLP valueAge (years)72 (40-77)74.5 (42-81)<.0011.0101.0001.021.045(10 year increments)Gender.023 F203 (33.2%)109 (41.4%)REF M409 (66.8%)154 (58.6%)1.0310.8651.229.733Aspirin Use.043 Not taking72 (11.8%)45 (17.1%)REF Taking540 (88.2%)218 (82.9%)0.7510.6070.929.008Major Complication<.001 No592 (96.7%)179 (68.1%)REF Yes20 (3.27%)84 (31.9%)4.4623.7425.321<.001Indication for Surgery<.001 Asymptomatic399 (65.2%)127 (48.3%)REF Symptomatic213 (34.8%)136 (51.7%)1.3021.0521.611.0150.398857143Operative Time (minutes)135 (120-155)146 (127-169)<.0011.0301.0061.062.014(30 minute increments)Anesthesia Type.004 General519 (85.1%)242 (92.4%)REF Regional91 (14.9%)20 (7.63%)0.5970.42390.84.003 Open table in a new tab
Abstract Background The Zenith® Fenestrated (ZFen) stent-graft is frequently configured with a strut-spanning large fenestration for superior mesenteric artery (SMA) incorporation. This has led some to relocate struts to create a strut-free fenestration and place a bridging stent. The aim of this study was to compare SMA outcomes with and without large fenestration strut relocation. Methods We performed a retrospective review of a prospective database of patients undergoing fenestrated endovascular repair with ZFen between 2013 and 2019. Those with SMA incorporation using large fenestrations were included and separated into strut relocation (SR) and no relocation (NR) groups. Endpoints included procedural metrics, technical success, major adverse events, and target-vessel instability. Results A total of 121 patients (77% male; mean age 76.1 ± 7.1 years) met inclusion criteria, including 94 with SR (78%) and 27 with NR (22%). A total of 369 target-vessels were incorporated, with a mean of 3.0 ± 0.2 per patient, and no differences between groups. Mean operative time, contrast volume, estimated blood loss, fluoroscopy time and radiation dose were lower (p < 0.001) with SR, attributed to increased experience with time. Overall technical success (SR: 100%, NR: 96%, p = 0.22) was 99%. At a mean follow-up of 32 months, there were two endovascular interventions for mesenteric ischemia. One resulted in SMA dissection requiring bypass in the NR group, the other was successful ballooning of the bridging stent with symptom resolution in the SR group. Conclusions Relocating the spanning struts does not negatively impact procedural metrics or midterm outcomes. It may facilitate future endovascular interventions.
The objective of this study was to determine the feasibility and safety of early postoperative ambulation with the bent-knee temporary prosthesis (BKTP). A single-center, Institutional Review Board-approved, retrospective analysis was conducted of patients who underwent below-knee amputation (BKA) and were discharged to inpatient rehabilitation at our institution between 2016 and 2019. Patients discharged from the hospital to other rehabilitation facilities were excluded from the study. Included patients were divided into BKTP (Fig) and control (no BKTP) groups on the basis of physical therapist and physiatrist evaluation. Those with ataxia, weak hip strength, previous knee arthroplasty, or short stump were not placed in the BKTP. Outcomes included time to formal prosthesis, distance of mobilization, falls, surgical reintervention, and disposition at discharge. A total of 109 patients underwent BKA during the study period; 34 (31.2%) met inclusion criteria, including 14 in the BTKP group (12.8%) and 20 in the control group (18.3%). There were no differences in demographics or comorbidities (Table) between groups (male, 65%; mean age: BKTP, 67 ± 7.2 years; control, 66.4 ± 9.5 years). The median time to postoperative ambulation with the BKTP was 14 (11-20) days. Both groups had an equal rate of successful ambulation in a formal prosthesis (86% BKTP vs 85% control; P = .95). There was a trend for lower rates of falls (21% vs 40%; P = .3), postoperative wound débridement (31% vs 60%; P = .10), and surgical revision (0% vs 10%; P = .10) in the BKTP group; however, this did not reach statistical significance. There were no instances of postoperative deep venous thrombosis, pulmonary embolism, pneumonia, or death. One patient in the BKTP group had a myocardial infarction. Median time to formal prosthesis was 153 (120-209) days and 221 (153-260) days (P = .08) for BKTP and control, respectively. There were no differences in discharge location (P = .3) or rehabilitation length of stay (P = .21). Outcomes of BKTP after BKA are similar to the control group, with no increased risk of postoperative fall or wound complications. BKTP allowed significantly more postoperative mobilization compared with the control. Further studies are needed to elucidate additional benefits of the BKTP.TableResults of a feasibility study for early ambulation with bent-knee temporary prosthesis (BKTP) after below-knee amputation (BKA)VariableBKTP (n = 14)Control (n = 20)P valueDemographics Age, years67.5 ± 7.266.4 ± 9.5.718 Male7 (50)13 (65).382 Indication for amputation.825Infection only5 (36)8 (40)Ischemia only5 (36)5 (25)Infection and ischemia4 (29)7 (35)Body mass index, kg/m228.1 ± 8.030.1 ± 8.4.475K-level at time of prosthetic1.00 01 (8)1 (5) 101 (5) 28 (62)12 (60) 34 (31)6 (30)Comorbidities Smoking history.188Current03 (15)Former8 (57)6 (30)Never6 (43)11 (55) Diabetes9 (64)16 (80).435 Hypertension13 (93)20 (100).412 Dyslipidemia14 (100)18 (90).501 CKD (GFR <60 mL/min/1.73 m2)6 (43)10 (50).681 ESRD (GFR <15 mL/min/1.73 m2) or on HD3 (21)3 (15).672 CAD9 (64)10 (50).409 CHF5 (36)6 (30).726Postoperative complications 30-day postoperative DVT, PE, pneumonia, or death00N/A MI 30 days postoperatively1 (7)0.412Long-term outcomes Received formal prosthesis12 (86)17 (85).954 Days until formal prosthesis153 (120-209)221 (153-260).084 Maximum ambulation distance, feet78 (50-150)5 (0-20)<.001 Documented falls in hospital3 (21)8 (40).295 Need for surgical débridement4 (31)12 (60).101 Need for surgical revision02 (10).501 Discharge dispositionHHC11 (79)12 (60).295Hospital01 (5)1.00TCU3 (21)7 (35).467 Length of stay at rehabilitation, days15 (12-20)12 (9-19).213CAD, Coronary artery disease; CHF, congestive heart failure; CKD, chronic kidney disease; DVT, deep venous thrombosis; ESRD, end-stage renal disease; GFR, glomerular filtration rate; HD, hemodialysis; HHC, home health care; MI, myocardial infarction, N/A, not applicable; PE, pulmonary embolism; TCU, transitional care unit.Categorical variables are presented as number (%). Continuous variables are presented as mean ± standard deviation or median (interquartile range). Open table in a new tab
The number of complex cases requiring percutaneous femoral arterial access is increasing. With the trend toward minimally invasive procedures, the pool of patients at risk for percutaneous complications has similarly increased. Severe complications that threaten life and limb often require vascular surgical intervention. This study evaluates vascular surgical complications following percutaneous femoral arterial access over a seven year span at a multidisciplinary center. Trends over time, between disciplines and practitioners as well as vascular closure device (VCD) usage were identified.
Abstract Background Endovascular rescue of failed infrarenal repair (EVAR) has emerged as an attractive option to stent graft explantation. The procedure, however, is underutilized due to limited devices accessibility and the challenges associated with their implantation in this patient population. The purpose of this study was to report our outcomes and discuss our approach to rescuing previously failed infrarenal endovascular aneurysm repairs (EVAR) with fenestrated/branched endografts (f/b-EVAR). Methods A retrospective analysis of prospectively collected data of consecutive patients with failed EVAR rescued with f/b-EVAR at our institution from November 2013 to March 2019 was conducted. The study primary end point was technical success; defined as the implantation of the device with no type I a/b or type III endoleak or conversion to open repair. Secondary endpoints included major adverse events (MAEs), graft patency and reintervention rates. Results During this time, 202 patients with complex aortic aneurysms were treated with f/b-EVAR. Of these, 19 patients (Male: 17, mean age 79 ± 7 years) underwent repair for failed EVAR. The median time from failed repair to f/b-EVAR was 48 (30, 60) months. Treatment failure was attributed to stent graft migration in 9 (47.4%) patients, disease progression in 5 (26.3%), short initial neck in 3 (15.8%) and unable to be determined in 2 (10.5%). Three patients were treated urgently with surgeon modified stent graft. Technical success was achieved in 18 patients (95%), including two who had undergone emergent repair for rupture. Seventy-two targeted vessels (97.3%) were successfully incorporated. Sixteen (84.2%) patients required a thoracoabdominal repair to achieve a durable seal. Major adverse events (MAEs) occurred in 3 patients (15.7%) including paralysis and death in one (5.3%), compartment syndrome and temporary dialysis in another and laparotomy with snorkeling of one renal and bypass of the other in the third patient. Median (IQR) hospital length of stay was 3 (2, 4) days. Late reintervention, primary target vessel patency and primary assisted patency rates were 5.3%, 98.6% and 100%, respectively. Conclusion Implantation of f/b-EVAR in patients with failed previous EVAR is a challenging undertaking that can be performed safely with a high technical success and low reintervention rates.
Background: Nonatherosclerotic abdominal arterial vasculopathies (NAVs), including mesenteric or renal artery dissection, aneurysm, stenosis, and vasculitis, are rare but have great clinical significance. Patients may present emergently with life-threatening complications such as arterial rupture and hemorrhagic shock. Herein, we present our center's experience with NAVs and provide extensive literature review to close the gap in the scarce, related literature. Methods: From a single-center retrospective data analysis, we identified and characterized subjects (aged 18-60 years) who presented with NAV between January 2000 and December 2015. Of the 1416 charts reviewed, 118 met inclusion criteria. Results: The average age of patients with NAV was 47.0 +/- 9.9 years, mostly affecting women (64%). Primary diagnoses included fibromuscular dysplasia (FMD) (25.4%), isolated aneurysms (24.6%), and median arcuate ligament syndrome (MALS) (15.3%). Less common diagnoses were localized vasculitis of the gastrointestinal tract (LVGT) (7.6%), isolated dissection (5.1%), microscopic polyangiitis and granulomatosis with polyangiitis (5.1%), trauma (4.2%), segmental arterial mediolysis (4.2%), Ehlers-Danlos syndrome (2.5%), Takayasu's arteritis (2.5%), polyarteritis nodosa (1.7%), idiopathic abdominal aortitis (0.8%), and Loeys-Dietz syndrome (0.8%). Females constituted 90% of patients with FMD, 77.8% with MALS, 77.8% with isolated aneurysms, 66.7% with Takayasu arteritis, and 55.6% with LVGT. Prevalent comorbidities included tobacco use (43.6%) and hypertension (52.1%). Coil embolization was used in 14.4%, anticoagulation in 11.9%, angioplasty/stenting in 11.9%, open resection/surgical revascularization in 10.2%, and prednisone in 10.2% of the cases. Conservative management was pursued in 33.1% of the patients. A high degree of symptom relief was shown in 91.7%. Conclusions: NAV are rare and can be caused by different etiologies that primarily affect females. Hypertension and tobacco use were prevalent. Various imaging strategies revealed aneurysms, stenosis, dissection, and/or thrombosis affecting renal and celiac arteries. Most patients improved with conservative, medical, endovascular, or surgical approach. More research is needed to standardize management approach to patients with NAV.
Objective: The objective of this study was to evaluate outcomes of patients with complex abdominal aortic aneurysms (cAAAs) treated with open repair (OR) or fenestrated/branched endovascular aneurysm repair (F/B-EVAR) from a single center. Methods: A retrospective analysis of consecutive patients with cAAAs treated electively by OR or F/B-EVAR between January 2010 and February 2017 was conducted. Demographics of the patients, cardiovascular risk factors, procedure time, number of vessels incorporated, radiation dose, estimated blood loss, intensive care unit (ICU) length of stay (LOS), and hospital LOS were recorded. End points included target vessel patency, aneurysm rupture, freedom from reintervention, and major adverse events (MAEs). Results: During this period, 153 patients (OR, 69; F/B-EVAR, 84) underwent repair of cAAA. The majority were male (OR, 55; F/B-EVAR, 64), with a mean age of 75.8 +/- 7.6 years (F/B-EVAR) and 71.2 +/- 7.9 years (OR). Patients in the F/B-EVAR group were more likely to be American Society of Anesthesiologists class 3 and 4 (60% vs 0%; P<.001) and had a higher median Society for Vascular Surgery/American Association for Vascular Surgery comorbidity severity score (15 vs 7; P<.001). A total of 235 vessels were targeted in the F/B-EVAR group, with a technical success of 97.6%. Thirty-one patients in the OR group required concomitant renal artery revascularization. Transfusion requirements (100% vs 1.2%), MAEs (40.6% vs 13.1%), procedure length (304 minutes vs 140 minutes), estimated blood loss (2246 mL vs 165 mL), ICU LOS (3 days vs 1 day), and hospital LOS (7 days vs 2 days) were higher (P<.001) in the OR group compared with the F/B-EVAR group. The 30-day mortality was 2.9% and 2.4% (P = .84) in the OR group and F/B-EVAR group, respectively. Supraceliac clamp site was associated with increased incidence of postoperative renal insufficiency. A decrease in procedure time, contrast volume, fluoroscopy time, and fluoroscopy dose was noted in the F/B-EVAR group with increasing experience even as case complexity increased. More patients were discharged home after F/B-EVAR (97.6% vs 59.4%; P<.001). With a mean follow-up of 31 months (F/B-EVAR, 17 months; OR, 48 months), the rate of secondary intervention was 3.7% and 5.8% (P = NS) for F/B-EVAR and OR, respectively. Freedom from branch instability and reintervention was 99% (95% confidence interval, 96.2%-99.8%) and 96% (95% confidence interval, 87.1%-98.6%), respectively. Conclusions: Results of this "real-world" experience suggest that the use of F/B-EVAR for the treatment of cAAAs in high-risk surgical patients is safe and effective and has comparable short-term results to those of low-risk patients undergoing OR. Patients treated by F/B-EVAR had shorter ICU and hospital LOS, lower MAEs, and faster convalescence. A decrease in procedure time and radiation dose was noted as experience was gained, even as complexity increased.
The BioMimics 3D self-expanding nitinol stent represents a strategy for femoropopliteal intervention that is alternative or complementary to deployment of drug-coated stents or balloons. Whereas conventional straight stents reduce arterial curvature and disturb blood flow, creating areas of low wall shear, where neointimal hyperplasia predominantly develops, the helical centerline geometry of the BioMimics 3D maintains or imparts arterial curvature, promotes laminar swirling blood flow, and elevates wall shear to protect against atherosclerosis and restenosis. In the multicenter randomized MIMICS trial, treatment of femoropopliteal disease with the BioMimics 3D (n = 50) significantly improved 2-year primary patency (log-rank test p = 0.05) versus a control straight stent (n = 26), with no cases of clinically driven target lesion revascularization between 12 and 24 months (log-rank test p = 0.03 versus controls). In geometric X-ray analysis, the BioMimics stent was significantly more effective in imparting a helical shape even when the arterial segment was moderately to severely calcified. Computational fluid dynamics analysis showed that average wall shear was significantly higher with the helical centerline stent (1.13 ± 0.13 Pa versus 1.06 ± 0.12 Pa, p = 0.05). A 271-patient multicenter international MIMICS-2 trial and a 500-patient real-world MIMICS-3D registry are underway.
The objective of this study was to evaluate the use of clopidogrel at the time of carotid endarterectomy (CEA) and its association with postoperative complications. This was a retrospective review of a prospective database. From 2010 to 2017, CEA was performed in 1066 consecutive patients (mean age, 72 years; 66% men). The indications for operation included ≥70% asymptomatic stenosis (458 [43%]), prior stroke (314 [29%]), and transient cerebral or retinal ischemia (294 [28%]). At the time of operation, 509 (48%) patients were taking aspirin alone, 441 (41%) were taking clopidogrel (374 in combination with aspirin, 67 as sole therapy), 83 (8%) were receiving no documented antiplatelet medication, and 33 (3%) were taking warfarin (with therapeutic international normalized ratio). The odds of clopidogrel use at the time of operation were higher for patients with a history of coronary artery disease (P = .002). During the study period, there was an increase in the number of patients taking clopidogrel (50% in 2010, 76% in 2016; P = .003). Postoperative strokes occurred in 15 patients (overall incidence, 1.4%), the majority of which were minor (12/15 [80%]). Six strokes occurred in patients taking aspirin alone (6/509 [1.2%]), two in patients taking clopidogrel and aspirin (2/441 [0.5%]), two in patients taking clopidogrel alone (2/67 [2.9%]), three in patients receiving no documented antiplatelet medication (3/83 [3.6%]), and two in those taking warfarin (one of which was secondary to a fatal intracranial hemorrhage within 30 days of discharge; 2/33 [6.1%]). The 30-day mortality rate was 0.03% (3/1066); the risk for the combined end point of any stroke, death, or myocardial infarction (MI) was 2.3% (25/1066), and the risk for major stroke, death, or MI was 1.2%. There was no apparent association between clopidogrel use and the incidence of postoperative bleeding (P = .59) or any other postoperative complication (stroke, death, MI, or cranial nerve injury; P = .15). Clopidogrel use in our CEA practice has increased over time and has not been associated with an increased risk of postoperative complications, including bleeding. These data suggest that clopidogrel should not be discontinued before CEA and should be considered part of “optimal medical therapy” in patients having CEA.
ABSTRACT Endovascular stenting of the carotid artery continues to incite debate among practitioners regarding its superiority over the traditional approach of carotid endarterectomy for reduction of stoke incidence. The 2013 Carotid Revascularization Endarterectomy versus Stenting Trial concluded there was no difference between the two techniques as carotid endarterectomy increased the prevalence of a nonfatal myocardial infarction while a higher incidence of strokes was observed after carotid stenting. The inclusion of myocardial infarction as part of the primary endpoint has drawn criticism; however, in this dispute, a key component is missing: the patient's perspective. A patient's values and fears are crucial to the choice between therapies carrying different risks. We surveyed 500 cardiovascular patients using a qualitative scale (from 1, not at all fearful, to 5, very fearful) to determine their level of fear of stroke, non-fatal myocardial infarction, and limb amputation as well as their understand...
BACKGROUND:Type II endoleak is the most commonly encountered endoleak after endovascular abdominal aortic aneurysm repair (EVAR). Some have advocated preoperative inferior mesenteric artery (IMA) embolization as a valid method for reducing the incidence of this endoleak, but controversies exist. We sought to demonstrate the impact of IMA embolization using a meta-analysis of currently available studies combined with our own experience. METHODS:We conducted an institutional review board-approved, retrospective analysis of all patients undergoing IMA embolization before EVAR between the years 2010 and 2015 and used as a control a similar group of patients with patent IMA. We divided patients from our own experience and 5 other studies into 2 groups: those who did not undergo IMA embolization (control) before EVAR and those who did. Rates of type II endoleaks, aneurysm sac regression, and secondary interventions were analyzed. RESULTS:A total of 620 patients from 6 studies were analyzed, including 258 patients who underwent an attempted IMA embolization before EVAR with a cumulative success rate of 99.2% (range, 93.8% to 100%). There was 1 fatality associated with IMA embolization. A meta-analysis showed that preoperative IMA embolization protected against type II endoleaks compared to the control group (odds ratio [OR], 0.31 [0.17-0.57]; P < 0.001, I2 = 43%). Furthermore, the rate of secondary intervention was significantly lower in the treatment group (OR, 0.12 [0.004-0.36]; P < 0.001, I2 = 0%). After IMA embolization, type II endoleak resulted from patent lumbar arteries in all 62 patients with persistent endoleak. CONCLUSIONS:Preoperative embolization of the IMA protects against the development of type II endoleaks and secondary interventions and may potentially lead to a rapid aneurysm sac regression. The procedure can be performed with a high technical success rate and minimal complications and should be considered in patients with IMA >3 mm before EVAR. A randomized trial, however, is required to clearly delineate the clinical significance of this technique.
The branches of the aortic arch include the Brachiocephalic (Innominate) (BCA), arising from the arch and dividing into the right subclavian and right common arteries, the left common carotid artery (CCA), and the left subclavian artery (LSA). Multiple disease processes can affect these vessels including atherosclerosis, vasculitis, radiation-induced injury, dissection, and aortic aneurysmal disease. Occlusive disease due to atherosclerosis is the most common cause of symptoms requiring treatment in this region. Options for treatment of occlusive disease of the brachiocephalic arteries include direct revascularization by endarterectomy or bypass, extra-anatomic bypass, or endovascular intervention including angioplasty or stenting. When considering an endovascular intervention of the aortic arch branches, preoperative planning is often the most important step. A thorough evaluation of imaging, thoughtful plan for access, and embolic protection maneuvers, along with stent selection and sizing, are a necessity for successful intervention with avoidance of complications.
Background: Current recommendations suggest lifetime follow-up for endovascular aortic aneurysm repair (EVAR) patients to avoid consequences associated with endoleak and aneurysm enlargement. Follow-up compliance has been reported between 43% and 92%, with most single-center studies citing successful follow-up surveillance at less than 60%. We investigated follow-up completeness with a defined surveillance program and subsequent secondary intervention prevalence from a single center. Methods: Our surveillance program notified patients of the need for follow-up imaging and surgeon review. Data were obtained from retrospective review of a prospective database, including operative and follow-up details, follow-up imaging completeness, endoleak incidence, and secondary intervention prevalence. Results: Five hundred seventeen patients received elective EVAR from 2005 to 2015. Surveillance was achieved in 425 (82.3%). Mean number of follow-up studies was 4.2 +/- 2.9 and median time to first follow-up was 36 days. Four hundred forty-eight patients (86.7%) had freedom from intervention. Sixty-nine unique patients (13.3%) had 107 secondary interventions. Median time to first secondary intervention in 69 patients was 476 days. Mean number of imaging studies for secondary intervention patients was 6.1 +/- 3.9, compared with mean 3.4 +/- 2.3 for patients without (P < 0.001). Overall mortality was 24.6% (n = 127), including 32 deaths of unknown cause (6.2% overall) and 95 of non-EVAR-related causes (18.3%). No aneurysm-related deaths were reported. Conclusions: Regular post-EVAR surveillance through a dedicated program resulted in a high rate of follow-up compliance, 13.3% rate of secondary intervention, and low aneurysm-related mortality. Careful lifetime surveillance remains important in long-term care following elective EVAR.
24 25 Introduction: Current recommendations suggest lifetime followup f or EVAR patients to avoid 26 consequences associated with endoleak and aneurysm enlargement. Followup compliance has 27 been reported between 43-92%, with most single-cent er studies citing successful followup 28 surveillance at less than 60%. We investigated foll owup completeness with a defined surveillance 29 program and subsequent secondary intervention preva lence from a single center. 30 Methods: Our surveillance program notified patients of the need for followup imaging and 31 surgeon review. Data were obtained from retrospecti v review of a prospective database, 32 including operative and follow-up details, followup imaging completeness, endoleak incidence 33 and secondary intervention prevalence. 34 Results: 517 patients received elective EVAR from 2005 to 2015. Surveillance was achieved in 35 425 (82.3%). Mean number of followup studies was 4. 2 ± 2.9 and median time to first followup 36 was 36 days. 448 (86.7%) patients had freedom from intervention. 69 unique patients (13.3%) 37 had 107 secondary interventions. Median time to fir st secondary intervention in 69 patients was 38 476 days. Mean number of imaging studies for second ary intervention patients was 6.1 ± 3.9, 39 compared to mean 3.4 ± 2.3 for patients without (p< 0.001). Overall mortality was 24.6% 40 (n=127), including 32 deaths of unknown cause (6.2% overall), and 95 of non-EVAR related 41 causes (18.3%). No aneurysm-related deaths were rep orted. 42 Conclusions 43 Regular post-EVAR surveillance through a dedicated program resulted in a high rate of followup 44 compliance, 13.3% rate of secondary intervention, a nd low aneurysm-related mortality. Careful 45 lifetime surveillance remains important in long-ter m care following elective EVAR. 46 47 48 49 M AN US CR IP T AC CE PT ED ACCEPTED MANUSCRIPT