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Low-frequency avoidable errors during transcarotid artery revascularization

Teter, Katherine; Lamparello, Patrick J; Barfield, Michael; Rockman, Caron B; Macdonald, Sumaira; Maldonado, Thomas S
OBJECTIVE:Transcarotid artery revascularization (TCAR) seems to be a safe and effective alternative to carotid endarterectomy (CEA) and transfemoral carotid artery stenting (TF-CAS). The TCAR system represents a paradigm shift in the management of carotid artery stenosis with potential for a significant decrease in periprocedural morbidity. However, as with CEA or TF-CAS, TCAR is associated with infrequent complications related to user technical error, most of which are preventable. Our goal is to describe these low-frequency events, and to provide guidelines for avoiding them. METHODS:The U.S. Food and Drug Administration (FDA) requires that all medical device manufacturers create a system for receiving, reviewing, and evaluating complaints (Code 21 of Federal Regulations 820.198). Silk Road Medical, Inc (Sunnyvale, Calif), has established a process by which all feedback, including complaints that may not meet FDA criteria, is captured and stored in a database for detailed analysis. More than 13,300 cases have been performed; submitted complaints were reviewed for incidents of serious injury and periprocedural complications, above and beyond the device-related events that must be reported to the FDA. RESULTS:A total of 13,334 patients have undergone TCAR worldwide between early 2011 and December 2019 using the SilkRoad device. Reported complications included 173 dissections (1.4% overall rate) of the common carotid artery at the access point, of which 22.5% were managed without intervention or with medical therapy alone and 24.3% were converted to CEA (considered failing safely). Errors in the location of stent deployment occurred in 16 cases (0.13%), with the most common site being the external carotid artery (75%). One wrong side carotid artery stent was placed in a patient with a high midline pattern of the bovine arch. Cranial nerve injury was reported in 11 cases (0.08%), only one of which persisted beyond 3 months. There have been three reported pneumothoraces and one reported chylothorax. Many of these errors can be recognized and prevented with careful attention to detail. CONCLUSIONS:In high-risk patients requiring treatment for carotid artery stenosis, TCAR has been proven as an alternative to TF-CAS with an excellent safety profile. As with CEA or TF-CAS, this procedure has the potential for infrequent complications, often as a result of user technical error. Although significant, these events can be avoided through a review of the collective experience to date and recognition of potential pitfalls, as we have described.
PMID: 33065241
ISSN: 1097-6809
CID: 4798402

Antegrade Superficial Femoral Artery Access for Lower Extremity Arterial Disease is Safe and Effective in the Outpatient Setting

Pezold, Michael; Blumberg, Sheila; Sadek, Mikel; Maldonado, Thomas; Cayne, Neal; Jacobowitz, Glenn; James, Herbert; Berland, Todd
INTRODUCTION/BACKGROUND:Antegrade superficial femoral artery (SFA) access for peripheral artery disease reduces the time, radiation and contrast required with contralateral common femoral access (CFA). Yet, this technique remains underutilized in the treatment of SFA, popliteal and tibial disease, and there remains limited data on the safety and effectiveness of antegrade SFA access in the outpatient setting. METHODS:A retrospective review of lower extremity peripheral arterial interventions in our office-based endovascular suite was conducted from 2013 to 2018. Interventions necessitating CFA access such as iliac, common femoral or deep femoral artery revascularization were excluded (n = 206). In addition, interventions potentially requiring large sheaths not amenable to SFA access (e.g. popliteal aneurysm) were excluded. Relevant demographic and treatment variables including postoperative complications were abstracted. RESULTS:We identified 718 patients, who underwent revascularization of the SFA, popliteal and tibial arteries. Antegrade SFA access was chosen in 448 patients (62.4%) with the remaining 270 patients having retrograde CFA access. Antegrade SFA access was achieved primarily with a 4 French sheath, while a majority of retrograde CFA interventions utilized a 6 French sheath for access (87.7% vs. 69.5%, p <0.001). Significantly less fluoroscopy (9.5 min vs 16.4 min, p <0.001) and contrast (25.4 mL vs. 38.5 mL, p <0.001) were used during SFA access compared with retrograde access. Technical success was achieved in 93.2% with antegrade SFA versus 94.8% retrograde CFA access (p 0.42). The overall rate of complications was low for both cohorts (2.7% vs. 3.7%, p 0.78) and there were no statistical differences in access-site complications (1.1% vs. 1.5%, p 0.94), hematoma (0.7% vs. 1.1%, p 0.84) and pseudoaneurysm (0.4% vs. 0%, p 0.98) between techniques. CONCLUSIONS:Percutaneous antegrade SFA access can be performed safely in the outpatient setting, and remains an effective alternative to retrograde CFA access with significantly less utilization of fluoroscopy and contrast.
PMID: 33271278
ISSN: 1615-5947
CID: 4694362

Closed Incision Negative Pressure Wound Therapy May Decrease Wound Complications in Major Lower Extremity Amputations

Chang, Heepeel; Maldonado, Thomas S; Rockman, Caron B; Cayne, Neal S; Berland, Todd L; Barfield, Michael E; Jacobowitz, Glenn R; Sadek, Mikel
OBJECTIVE:Wound complications after major lower extremity amputations are a cause of significant morbidity in vascular surgery patients. Recent publications have demonstrated the efficacy of the closed incision negative pressure dressing at preventing surgical site infections (SSIs); however, there are limited data on its use in major lower extremity amputations. This study sought to assess if closed incision negative pressure wound therapy (NPWT) would reduce the risk of complications as compared to a standard dressing in patients with peripheral vascular disease undergoing major lower extremity amputation. METHODS:system (Acelity L.P. Inc., San Antonio, TX, USA) was applied intraoperatively at the discretion of the operating surgeon and removed 5 to 7 days postoperatively. The standard group received a non-adherent dressing with an overlying compression dressing. Amputation incisions were assessed and wound complications were recorded. Student's t-test and two-sample proportion z-test were used for statistical analysis. A P value < .05 was considered statistically significant. RESULTS:For comorbidities, there was a higher incidence of tobacco use in the NPWT as compared to the standard group (44% vs. 13%; P = .011), as well as trends towards increased prior amputations, anemia, hyperlipidemia, and chronic obstructive pulmonary disorder in the NPWT group. For risk factors, there were more dirty wounds in the NPWT as compared to the standard group (52% vs. 26%; P = .046). For outcomes, there were fewer wound complications in the NPWT as compared to the standard group (13% vs. 39%; P = .037). The types of wound-related complications in the NPWT group included one wound dehiscence with a deep SSI, one superficial SSI and one incision line necrosis. In the standard group, there were 4 wound dehiscences with deep SSI, 3 superficial SSIs, 4 incision line necroses and 1 stump hematoma. The rates of perioperative mortality and amputation revision did not differ significantly between the NPWT and the standard group (3% vs. 4% and 4.3% vs. 10%, respectively). CONCLUSIONS:Closed incision negative pressure wound therapy may decrease the incidence of wound complications in vascular patients undergoing major lower extremity amputation. This held true even amongst a population that was potentially at higher risk. This therapy may be considered for use in lower extremity major amputations.
PMID: 32707380
ISSN: 1097-6809
CID: 4539842

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

Iliofemoral Venous Stenting May Contribute to Improving Femoropopliteal Deep Vein Reflux [Meeting Abstract]

Pergamo, M; Kabnick, L; Jacobowitz, G; Rockman, C; Maldonado, T; Berland, T; Blumberg, S; Sadek, M
Background: Severe presentations of chronic venous insufficiency may result from reflux or obstruction at the deep venous, perforator or superficial venous levels. Iliofemoral venous stenting may be used to address central venous obstruction, but its effect on deep venous reflux remains unclear. The purpose of this study was to evaluate the effect of iliac vein stenting on femoropopliteal deep vein reflux with the hypothesis that sonographic evidence of deep vein reflux would remain absent or improve following iliac vein stenting.
Method(s): This study was a retrospective review of patients undergoing iliofemoral venous stenting from 2013-2020. Patients were divided into two cohorts based on the preprocedural presence (Group A) or absence (Group B) of femoropopliteal reflux. Baseline patient variables were collected including age, gender, CEAP, presence of concomitant superficial or perforator reflux, DVT history, and additional venous intervention(s). The primary outcome evaluated was the persistent absence or the resolution of deep vein reflux on the latest venous duplex ultrasound follow-up. Other outcomes included follow-up CEAP classification as well as need for secondary deep venous interventions.
Result(s): There were 275 consecutive patients who underwent iliofemoral venous stenting. Of those, 58 presented with deep vein reflux (Group A), and the remaining did not (Group B). When comparing Group A and Group B, patients in Group A had a higher likelihood of prior DVT (P =.0001) as well as higher frequency of venous ablation (Table). The remaining demographics did not differ significantly between the two groups. In Group A, deep vein reflux resolved in follow-up in 17/51 patients (P =.0001). In Group B, deep vein reflux developed on follow-up in 6/217 patients. CEAP appeared to improve from preintervention (C0, 1.1%; C1, 0.4%; C2, 1.8%; C3, 41.4%; C4, 24.9%; C5, 5.9%; and C6, 24.5%) to latest follow-up (C0, 4.9%; C1, 1.9%; C2, 5.7%; C3, 34.2%; C4, 22.8%; C5, 17.1%; and C6, 13.3%).
Conclusion(s): For patients who undergo iliofemoral vein stenting, deep vein reflux may improve if present initially, and is unlikely to develop if not present prior to intervention. A cohort of patients maintained persistent deep vein reflux, and these warrant further evaluation. Prospective studies are required to corroborate the safety, efficacy and durability of iliofemoral venous stenting in patients with deep vein reflux. [Formula presented]
Copyright
EMBASE:2010941746
ISSN: 2213-3348
CID: 5184222

Risk of thrombotic events after respiratory infection requiring hospitalization

Smilowitz, Nathaniel R; Subashchandran, Varun; Newman, Jonathan; Barfield, Michael E; Maldonado, Thomas S; Brosnahan, Shari B; Yuriditsky, Eugene; Horowitz, James M; Shah, Binita; Reynolds, Harmony R; Hochman, Judith S; Berger, Jeffrey S
Thrombosis is a major concern in respiratory infections. Our aim was to investigate the magnitude and duration of risk for arterial and venous thrombosis following discharge after respiratory infection. Patients with respiratory infections were identified using the United States Nationwide Readmission Database from 2012 to 2014. Patients admitted with asthma or cellulitis served as comparators. Readmissions for acute myocardial infarction (MI) and venous thromboembolism (VTE) were evaluated at 30 to 180 days. The likelihood of a first thrombotic event after discharge was compared with a 30-day period prior to hospitalization. Among 5,271,068 patients discharged after a respiratory infection, 0.56% and 0.78% were readmitted within 30-days with MI and VTE, respectively. Relative to asthma and cellulitis, respiratory infection was associated with a greater age and sex-adjusted hazard of 30-day readmission for MI (adjusted HR [aHR] 1.48 [95% CI 1.42-1.54] vs. asthma; aHR 1.36 [95% CI 1.31-1.41] vs. cellulitis) and VTE (aHR 1.28 [95% CI 1.24-1.33] vs. asthma; aHR 1.26, [95% CI 1.22-1.30] vs. cellulitis). Risks of MI and VTE attenuated over time. In a crossover-cohort analysis, the odds of MI (OR 1.68 [95% CI 1.62-1.73]) and VTE (OR 3.30 [95% 3.19-3.41]) were higher in the 30 days following discharge after respiratory infection than during the 30-day baseline period. Hospitalization for respiratory infection was associated with increased risks of thrombosis that were highest in the first 30-days after discharge and declined over time.
PMID: 33602977
ISSN: 2045-2322
CID: 4787172

Pulmonary Embolism Response Team activation during the COVID-19 pandemic in a New York City Academic Hospital: a retrospective cohort analysis

Kwok, Benjamin; Brosnahan, Shari B; Amoroso, Nancy E; Goldenberg, Ronald M; Heyman, Brooke; Horowitz, James M; Jamin, Catherine; Sista, Akhilesh K; Smith, Deane E; Yuriditsky, Eugene; Maldonado, Thomas S
Coronavirus disease 2019 (COVID-19) is associated with increased rates of deep vein thrombosis (DVT) and pulmonary embolism (PE). Pulmonary Embolism Response Teams (PERT) have previously been associated with improved outcomes. We aimed to investigate whether PERT utilization, recommendations, and outcomes for patients diagnosed with acute PE changed during the COVID-19 pandemic. This is a retrospective cohort study of all adult patients with acute PE who received care at an academic hospital system in New York City between March 1st and April 30th, 2020. These patients were compared against historic controls between March 1st and April 30th, 2019. PE severity, PERT utilization, initial management, PERT recommendations, and outcomes were compared. There were more cases of PE during the pandemic (82 vs. 59), but less PERT activations (26.8% vs. 64.4%, p < 0.001) despite similar markers of PE severity. PERT recommendations were similar before and during the pandemic; anticoagulation was most recommended (89.5% vs. 86.4%, p = 0.70). During the pandemic, those with PERT activations were more likely to be female (63.6% vs. 31.7%, p = 0.01), have a history of DVT/PE (22.7% vs. 1.7%, p = 0.01), and to be SARS-CoV-2 PCR negative (68.2% vs. 38.3% p = 0.02). PERT activation during the pandemic is associated with decreased length of stay (7.7 ± 7.7 vs. 13.2 ± 12.7 days, p = 0.02). PERT utilization decreased during the COVID-19 pandemic and its activation was associated with different biases. PERT recommendations and outcomes were similar before and during the pandemic, and led to decreased length of stay during the pandemic.
PMID: 32910409
ISSN: 1573-742x
CID: 4589422

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

Thrombus Removal With ClotTriever in the ClotTriever Outcomes Registry: The Effect of Thrombus Chronicity [Meeting Abstract]

Maldonado, Thomas
ISI:000707158200096
ISSN: 0741-5214
CID: 5074092

Effect of Ipsilateral Carotid Revascularization on Contralateral Carotid Duplex Ultrasound Parameters [Meeting Abstract]

Garg, Karan; Jacobowitz, Glenn; Cayne, Neal; Maldonado, Thomas; Lamparello, Patrick; Chandra, Pratik; Rockman, Caron
ISI:000707158200132
ISSN: 0741-5214
CID: 5074102