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Adjunctive false lumen intervention for chronic aortic dissections is safe but offers unclear benefit

Rokosh, Rae S; Chen, Stacey; Cayne, Neal; Siracuse, Jeffrey J; Patel, Virendra I; Maldonado, Thomas S; Rockman, Caron B; Barfield, Michael E; Jacobowitz, Glenn R; Garg, Karan
OBJECTIVE:Adjunctive false lumen embolization (FLE) with thoracic endovascular aortic repair (TEVAR) in patients with chronic aortic dissection is thought to induce FL thrombosis and favorable aortic remodeling. However, these data are derived from small single-institution experiences and the potential benefit of FLE remains unproven. In this study, we examined perioperative and midterm outcomes of patients with aortic dissection undergoing concomitant TEVAR and FLE.* METHODS: Patients 18 or older who underwent TEVAR for chronic aortic dissection with known FLE status in the Society for Vascular Surgery Vascular Quality Initiative database between January 2010 and February 2020 were included. Ruptured patients and emergent procedures were excluded. Patient characteristics, operative details and outcomes were analyzed by group: TEVAR with or without FLE. Primary outcomes were in-hospital post-operative complications and all-cause mortality. Secondary outcomes included follow-up mean maximum aortic diameter change, rates of false lumen thrombosis, re-intervention rates, and mortality. RESULTS:884 patients were included: 46 had TEVAR/FLE and 838 had TEVAR alone. There was no significant difference between groups in terms of age, gender, comorbidities, prior aortic interventions, mean maximum pre-operative aortic diameter (5.1cm vs. 5.0cm, P=0.43), presentation symptomatology, or intervention indication. FLE was associated with significantly longer procedural times (178min vs. 146min, P=0.0002), increased contrast use (134mL vs. 113mL, P=0.02), and prolonged fluoroscopy time (34min vs. 21min, P<0.0001). However, FLE was not associated with a significant difference in post-operative complications (17.4% vs. 13.8%, P=0.51), length of stay (6.5 vs. 5.7 days, P=0.18), or in-hospital all-cause mortality (0% vs. 1.3%, P=1). In mid-term follow-up (median 15.5months, IQR 2.2-36.2 months), all-cause mortality trended lower, but was not significant (2.2% vs. 7.8%); and Kaplan-Meier analysis demonstrated no difference in overall survival between groups (P=0.23). By Cox regression analysis, post-operative complications had the strongest independent association with all-cause mortality (HR 2.65, 95% CI 1.56-4.5, P<0.001). In patients with available follow-up imaging and re-intervention status, mean aortic diameter change (n=337, -0.71cm vs. -0.69cm, P=0.64) and re-intervention rates (n=487, 10% vs. 11.4%, P=1) were similar. CONCLUSIONS:Adjunctive FLE, despite increased procedural times, can be performed safely for patients with chronic dissection without significantly higher overall perioperative morbidity or mortality. TEVAR/FLE demonstrates trends for improved survival and increased rates of FL thrombosis in the treated thoracic segment; however, given the lack of evidence to suggest a significant reduction in re-intervention rates or induction of more favorable aortic remodeling compared to TEVAR alone, the overall utility of this technique in practice remains unclear. Further investigation is needed to determine the most appropriate role for FLE in managing chronic aortic dissections.
PMID: 33838234
ISSN: 1615-5947
CID: 4889042

Smaller Superficial Femoral Artery is associated with Worse Outcomes after Percutaneous Transluminal Angioplasty for De Novo Atherosclerotic Disease

Chang, Heepeel; Veith, Frank J; Rockman, Caron B; Cayne, Neal S; Babaev, Anvar; Jacobowitz, Glenn R; Ramkhelawon, Bhama; Patel, Virendra I; Garg, Karan
BACKGROUND:With the exponential increase in the use of endovascular techniques in the treatment of peripheral artery disease, our understanding of factors that affect intervention failures continues to grow. We sought to assess the outcomes of percutaneous transluminal angioplasty for isolated de novo superficial femoral artery (SFA) disease based on balloon diameter. METHODS:The Vascular Quality Initiative database was queried for patients undergoing percutaneous balloon angioplasty for isolated de novo atherosclerotic SFA disease. Based on the diameter of the angioplasty balloon as a surrogate measure of arterial diameter, patients were stratified into two groups: group 1, balloon diameter < 5 mm (354 patients) and group 2, balloon diameter ≥ 5 mm (1,550 patients). The primary patency and major adverse limb event (MALE) were estimated by the Kaplan-Meier method and compared with the log-rank test, based on vessel diameter. multivariable Cox regression analysis was used to determine factors associated with the primary patency. RESULTS:From January 2010 through December 2018, a total of 1,904 patients met criteria for analysis, with a mean follow-up of 13.3 ± 4.5 months. The mean balloon diameters were 3.92 ± 0.26 mm and 5.47 ± 0.55 mm in group 1 and 2, respectively (P<.001). The mean length of treatment and distribution of TASC lesions were not statistically different between the groups. Primary patency at 18 months was significantly lower in group 1, compared with group 2 (55% vs 67%; log-rank P<.001). The MALE rate was higher in group 1 than group 2 (33% vs 26%; log-rank P<.001). Among patients with claudication, there was no significant difference in the primary patency (61% vs 68%; log-rank P=.073) and MALE (27% vs 22%; log-rank P=.176) at 18 months between groups 1 and 2, respectively. However, in patients with CLTI, group 1 had significantly lower 18-month primary patency (47% vs 64%; log-rank P<.014) and higher MALE rates (41% vs 35%; log-rank P=.012) than group 2. Cox proportional hazard analysis confirmed that balloon diameter < 5 mm was independently associated with increased risks of primary patency loss (HR 1.35; 95% CI, 1.04-1.72; P=.021) and MALE (HR 1.29; 95% CI, 1-1.67; P=.048) at 18-months. CONCLUSIONS:In patients undergoing isolated SFA balloon angioplasty for CLTI, smaller SFA (< 5mm) was associated with worse primary patency and MALE. Using balloon size as a surrogate, our findings suggest that patients with a smaller SFA diameter appear to be at increased risk for treatment failure and warrant closer surveillance. Furthermore, these patients may also be considered for alternative approaches, including open revascularization.
PMID: 33838233
ISSN: 1615-5947
CID: 4845472

Histological Assessment of Lower Extremity Deep Vein Thrombi from Patients Undergoing Percutaneous Mechanical Thrombectomy

Yuriditsky, Eugene; Narula, Navneet; Jacobowitz, Glenn R; Moreira, Andre L; Maldonado, Thomas S; Horowitz, James M; Sadek, Mikel; Barfield, Michael E; Rockman, Caron B; Garg, Karan
BACKGROUND:Histological analyses of deep vein thrombi (DVT) are based on autopsy samples and animal models. No prior study has reported on thrombus composition following percutaneous mechanical extraction. As elements of chronicity and organization render thrombus resistant to anticoagulation and thrombolysis, a better understanding of clot evolution may inform therapies. METHODS:We performed histologic evaluation of DVTs from consecutive patients undergoing mechanical thrombectomy for extensive iliofemoral DVTs using the Clottriever/ Flowtriever device (Inari Medical, Irvine, CA). Thrombi were scored in a semi-quantitative manner based on the degree of fibrosis (collagen deposition on trichrome stain), and organization (endothelial growth with capillaries and fibroblastic penetration). RESULTS:Twenty-three specimens were available for analysis with 20 presenting with acute DVT (≤14 days from symptom onset). Eleven of 23 patients (48%) had >5% fibrosis (collagen deposition) and 14/23 patients (61%) had >5% organization (endothelial growth, capillaries, fibroblasts). Four patients with acute DVT had ≥25% organized thrombus and 2 had ≥ 25% collagen deposition. Among the 20 patients with acute DVT, 40% had >5% fibrosis and 55% had > 5% organization. Acuity of DVT did not correlate with the fibrosis or organizing scores. CONCLUSIONS:A large proportion of patients with acute DVT have histologic elements of chronicity and fibrosis. A better understanding of the relationship between such elements and response to anticoagulants and fibrinolytics may inform our approach to therapeutics.
PMID: 33836286
ISSN: 2213-3348
CID: 4839682

Interplay of Diabetes Mellitus and End-Stage Renal Disease in Open Revascularization for Chronic Limb Threatening Ischemia

Chang, Heepeel; Rockman, Caron B; Jacobowitz, Glenn R; Cayne, Neal S; Veith, Frank J; Han, Daniel K; Patel, Virenda I; Kumpfbeck, Andrew; Garg, Karan
OBJECTIVES/OBJECTIVE:Chronic limb threatening ischemia (CLTI) in patients with end-stage renal disease (ESRD) confers a significant survival disadvantage and is associated with a high major amputation rate. Moreover, diabetes mellitus (DM) is an independent risk factor for developing CLTI. However, the interplay between end stage renal disease (ESRD) and DM on outcomes after peripheral revascularization for CLTI is not well established. Our goal was to assess the effect of DM on outcomes after an infrainguinal bypass for CLTI in patients with ESRD. METHODS:Using the Vascular Quality Initiative dataset from January 2003 to March 2020, records for all primary infrainguinal bypasses for CLTI in patients with ESRD were included for analysis. One-year and perioperative outcomes of all-cause mortality, reintervention, amputation-free survival (AFS) and major adverse limb event (MALE) were compared for patients with DM versus those without DM. RESULTS:Of a total of 1,058 patients (66% male) with ESRD, 726 (69%) patients had DM, and 332 patients did not have DM. The DM group was younger (median age, 65 years vs. 68 years; P=.002), with higher proportions of obesity (body-mass index>30kg/m2; 34% vs. 19%; P<.001) and current smokers (26% vs. 19%; P=.013). The DM group presented more frequently with tissue loss (76% vs. 66%; P<.001). A distal bypass anastomosis to tibial vessels was more frequently performed in the DM group compared to the non-DM group (57% vs. 45%; P<.001). DM was independently associated with higher perioperative MALE (OR 1.34; 95% CI, 1.06-1.68; P=.013), without increased risks of loss of primary patency and composite outcomes of amputation or death. On the mean follow-up of 11.4 ± 5.5 months, DM patients had a significantly higher rate of one-year MALEs (43% vs. 32%; P=.001). However, the one-year primary patency and AFS, did not differ significantly. After adjusting for confounders, the risk-adjusted hazards for MALE (HR 1.34; 95% CI, 1.06-1.68; P=.013) were significantly increased in patients with DM. However, DM was not associated with increased risk of AFS (HR 1.16; 95% CI, 0.91-1.47; P=.238), or loss of primary patency (HR 1.04; 95% CI, 0.79-1.37; P=.767). CONCLUSION/CONCLUSIONS:DM and ESRD each independently predict early and late major adverse limb events after an infrainguinal bypass in patients presenting with CLTI. However, in the presence of ESRD, DM may increase perioperative adverse events, but does not influence primary patency and AFS at one-year. The risk profile associated with ESRD appears to supersede that of DM, with no additive effect.
PMID: 33227468
ISSN: 1615-5947
CID: 4680342

Effect of Anticoagulation and Antiplatelet Medications on Aortic Remodeling after Thoracic Endovascular Aortic Repair for Type B Aortic Dissection [Meeting Abstract]

Chang, H; Rockman, C B; Cayne, C S; Jacobowitz, G R; Veith, F J; Patel, V I; Garg, K
Background: To date, few studies adequately evaluate the impact of anticoagulation and antiplatelet medications on aortic remodeling for type B thoracic dissection (TBAD) after thoracic endovascular aortic repair (TEVAR). As such, we assessed the relationship between chronic anticoagulation/antiplatelet medications and aortic remodeling of patients with TBAD after TEVAR.
Method(s): Records of the Vascular Quality Initiative TEVAR registry (2011-2019) were reviewed. Procedures performed for dissection-related pathology were included. Primary outcomes included complete false lumen thrombosis, reintervention-free survival and endoleak at 18 months. Primary outcomes were compared between patients with and without chronic anticoagulants (AC and non-AC). A subgroup analysis was performed to assess the effect of antiplatelet medications (none, single antiplatelet, and dual antiplatelets) in the non-AC group. Cox proportional hazards models were used to estimate the effect of different antithrombotic therapies on primary outcomes.
Result(s): We identified 1507 patients (mean age, 60.7 +/- 12.2 years; 68.3% male) with a mean follow-up of 18.9 +/- 13.7 months. Two hundred one (14%) patients were on anticoagulation therapy at follow-up. There were no differences in the mean preoperative thoracic aortic diameter or the number of endografts used. The status of false lumen thrombosis and endoleaks were available in 648 (43%) and 1023 patients (68%), respectively. At 18 months, the rates of complete false lumen thrombosis (51.3% vs 47.5%; P =.182), reinterventions (9% vs 10.6%; P =.175), all-cause mortality (97.6% vs 96.9%; P =.561), and endoleaks (18.8% vs 22%; P =.397) were similar in the AC and non-AC groups, respectively (Fig). Controlling for covariates with the Cox regression method, AC use was not independently associated with a decreased risk of complete false lumen thrombosis (hazard ratio [HR], 0.79; 95% confidence interval [CI], 0.54-1.16; P =.235) or increased risks of reintervention (HR, 1.06; 95% CI, 0.9-1.24; P =.484) and endoleak (HR, 0.97; 95% CI, 0.83-1.14; P =.725). Within the non-AC group, antiplatelet medications did not affect the rates of complete false lumen thrombosis, reintervention, or endoleak.
Conclusion(s): The use of chronic anticoagulation and antiplatelet medications did not adversely affect the rate of complete false lumen thrombosis and positive aortic remodeling in patients who underwent TEVAR for TBAD. Anticoagulation and antiplatelet medications may be safely used in patients who undergo TEVAR for TBAD. [Formula presented]
Copyright
EMBASE:2011035889
ISSN: 1097-6809
CID: 4805582

A novel approach to percutaneous aortic thrombectomy [Case Report]

Silverglate, Quinn; Maldonado, Thomas S; Narula, Navneet; Garg, Karan
Aortic mural thrombus in the absence of underlying aortic disease is rare and results in a risk of distant arterial embolization that can result in limb loss or other end organ damage. Current management involves open surgery, anticoagulation, and systemic thrombolysis; however, each carries inherent risks. We report the case of aortic thrombus with distal emboli in two patients, a 56-year-old man and a 68-year-old man, neither with underlying aortic pathology and both presenting with limb threatening ischemia. We performed percutaneous mechanical thrombectomy using the FlowTriever System (Inari Medical, Irvine, Calif) with successful removal of the aortic thrombus in both patients.
PMCID:7921181
PMID: 33718682
ISSN: 2468-4287
CID: 4815172

Ambulatory Status following Major Lower Extremity Amputation

MacCallum, Katherine P; Yau, Patricia; Phair, John; Lipsitz, Evan C; Scher, Larry A; Garg, Karan
BACKGROUND:The ability to ambulate following major lower extremity amputation, either below (BKA) or above knee (AKA), is a major concern for all prospective patients. This study analyzed ambulatory rates and risk factors for nonambulation in patients undergoing a major lower extremity amputation. METHODS:A retrospective review of 811 patients who underwent BKA or AKA at our institution between January 2009 and December 2014 was conducted. Demographic information and co-morbid conditions, including the patients' functional status prior to surgery, at 6 months, and at latest follow up were recorded. Following exclusion criteria, 538 patients were included. Patients who were either independent or used an assistive device were considered ambulatory, while those who were completely wheelchair-dependent or bed-bound were considered nonambulatory. RESULTS:Pre-operatively, 83.1% of BKA patients were ambulatory, significantly more so than those undergoing AKA (44.9%, P < 0.0001). At 6-month follow-up these percentages dropped to 58.0% and 25.2%, respectively, for all patients. For patients who were ambulatory pre-operatively, 182/246 (73.9%) of BKA and 32/51 (62.7%) of AKA remained so post-amputation. Of those patients with both 6-month and greater than 1-year follow-up, there was no change in ambulatory status between the 2 time periods. On multivariable logistic regression, age greater than 70 years and female sex were associated with nonambulation post-operatively (P = 0.001, P = 0.015, respectively). None of the co-morbid conditions recorded (diabetes, renal insufficiency, end-stage renal disease, peripheral vascular disease, or body mass index > 35) was found to have a statistically significant correlation with post-operative ambulation using multivariable analysis. CONCLUSIONS:The majority of ambulatory patients undergoing a major amputation were able to remain ambulatory. Patients who failed to ambulate 6 months after their amputation, failed to resume ambulating. Age greater than 70 and female sex were found to have a statistically significant association with becoming nonambulatory following surgery.
PMID: 32768533
ISSN: 1615-5947
CID: 4614342

Adjunctive False Lumen Intervention for Aortic Dissection Is Safe But Offers Unclear Benefit [Meeting Abstract]

Rokosh, R S; Cayne, N; Siracuse, J J; Patel, V; Maldonado, T; Rockman, C; Barfield, M E; Jacobowitz, G; Garg, K
Introduction and Objectives: Adjunctive false lumen embolization (FLE) with thoracic endovascular aortic repair (TEVAR) in patients with chronic aortic dissection is thought to induce FL thrombosis and favorable aortic remodeling. However, evidence is limited and the potential benefit of FLE remains unproven.
Method(s): Patients 18+ who underwent TEVAR for chronic aortic dissection with known FLE status in the SVS VQI database 1/2010-2/2020 were included. Ruptured patients and emergent procedures were excluded. Primary outcomes were in-hospital post-operative complications and all-cause mortality. Secondary outcomes included follow-up maximum aortic diameter change, re-intervention rates, and mortality.
Result(s): 884 patients were included: 46 had TEVAR/FLE and 838 had TEVAR alone. There was no significant difference between groups in terms of age, gender, comorbidities, maximum pre-operative aortic diameter, presentation symptomatology, or intervention indication. FLE was associated with significantly longer procedural times (178min vs. 146min, p=0.0002), increased contrast use (134mL vs. 113mL, p=0.02), and prolonged fluoroscopy time (34min vs. 21min, p<0.0001), but not associated with a significant difference in post-operative complications (17.4% vs. 13.8%, p=0.51), length of stay (6.5 vs. 5.7 days, p=0.18), or in-hospital all-cause mortality (0% vs. 1.3%, p=1). In mid-term follow-up (median 15.5months), all-cause mortality trended lower, but was not significant (2.2% vs. 7.8%); Kaplan-Meier analysis demonstrated no difference in overall survival between groups (p=0.23). Post-operative complications had the strongest independent association with all-cause mortality (HR 2.65, 95% CI 1.56-4.5, p<0.001). In patients with available follow-up imaging and re-intervention status, mean aortic diameter change (n=337, -0.71cm vs. -0.69cm, p=0.64) and re-intervention rates (n=487, 10% vs. 11.4%, p=1) were similar.
Conclusion(s): Adjunctive FLE can be performed safely in chronic thoracic aortic dissections without significantly higher perioperative morbidity or mortality. However, given lack of reduction in re-intervention rates, induction of significant favorable aortic remodeling, or definitive survival benefit compared to TEVAR alone, FLE utility remains unclear.
Copyright
EMBASE:2011052086
ISSN: 1615-5947
CID: 4811972

The Effect of COVID-19 on Training and Case Volume of Vascular Surgery Trainees

Ilonzo, Nicole; Koleilat, Issam; Prakash, Vivek; Charitable, John; Garg, Karan; Han, Daniel; Faries, Peter; Phair, John
BACKGROUND/UNASSIGNED:In many facilities, the coronavirus disease (COVID-19) pandemic caused suspension of elective surgery. We therefore sought to determine the impact of this on the surgical experience of vascular trainees. METHODS/UNASSIGNED:Surgical case volume, breadth, and the participating trainee post-graduate level from 3 large New York City Hospitals with integrated residency and fellowship programs (Mount Sinai, Montefiore Medical Center/Albert Einstein College of Medicine, and New York University) were reviewed. Procedures performed between February 26 to March 25, 2020 (pre-pandemic month) and March 26 to April 25, 2020 (peak pandemic period) were compared to those performed during the same time period in 2019. The trainees from these programs were also sent surveys to evaluate their subjective experience during this time. RESULTS/UNASSIGNED:The total number of cases during the month leading into the peak pandemic period was 635 cases in 2019 and 560 cases in 2020 (12% decrease). During the peak pandemic period, case volume decreased from 445 in 2019 to 114 in 2020 (74% reduction). The highest volume procedures during the peak pandemic month in 2020 were amputations and peripheral cases for acute limb ischemia; during the 2019 period, the most common cases were therapeutic endovascular procedures. There was a decrease in case volume for vascular senior residents of 77% and vascular junior and midlevel residents of 75%. There was a 77% survey response rate with 50% of respondents in the senior years of training. Overall, 20% of respondents expressed concern about completing ACGME requirements due to the COVID-19 pandemic. CONCLUSIONS/UNASSIGNED:Vascular surgery-specific clinical educational and operative experiences during redeployment efforts have been limited. Further efforts should be directed to quantify the impact on training and to evaluate the efficacy of training supplements such as teleconferences and simulation.
PMCID:7803789
PMID: 33427109
ISSN: 1938-9116
CID: 4771392

Upper Extremity Arterial Thromboembolism in a Coronavirus Patient. A Case Report

Scott, Beverley-Ann; Garg, Karan; Johnson, William; Al-Ajam, Mohammad; Patalano, Peter; Rotella, Vittorio; Edwards, Jodi-Ann; Aboushi, Haytham; Lee, Paul; Daniel, Melissa; Rancy, Schneider; Heimann, David
The coronavirus disease 2019 pandemic has impacted millions of people worldwide. This novel virus has a variety of presentations and complications. Notably, patients with this infection have an associated coagulopathy, presenting with symptoms such as gastrointestinal bleeds, deep vein thrombosis, ischemic cerebrovascular events, and pulmonary embolism. Although there are documented cases of venous thromboembolism in patients with coronavirus disease 2019, the authors present an interesting case of upper extremity arterial thromboembolism in a 75-year-old patient surgically treated for arterial thrombus removal. We also discuss diagnosis, medical management, and surgical approach to an upper extremity arterial thromboembolism in a patient with coronavirus disease 2019, to highlight the challenges of hypercoagulability in such patients.
PMCID:7788384
PMID: 33432306
ISSN: 2523-8973
CID: 5005692