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Arterial thromboembolism associated with COVID-19 and elevated D-dimer levels [Case Report]
Garg, Karan; Barfield, Michael E; Pezold, Michael L; Sadek, Mikel; Cayne, Neal S; Lugo, Joanelle; Maldonado, Thomas S; Berland, Todd L; Rockman, Caron B; Jacobowitz, Glenn R
The novel coronavirus 2019 (SARS-CoV-2) was first identified in January 2020 and has since evolved into a pandemic affecting >200 countries. The severity of presentation is variable and carries a mortality between 1% and 3%. We continue to learn about the virus and the resulting acute respiratory illness and hypercoagulability; however, much remains unknown. In our early experience in a high-volume center, we report a series of four cases of acute peripheral artery ischemia in patients with COVID-19 in the setting of elevated D-dimer levels.
PMCID:7297695
PMID: 32704579
ISSN: 2468-4287
CID: 4539752
Intraoperative Management and Factors Contributing to Intolerance of Reversal of Flow in Transcarotid Artery Revascularization [Meeting Abstract]
Teter, K; Rockman, C; Lamparello, P; Garg, K; Barfield, M; Jacobowitz, G; Maldonado, T S
Objective: In patients deemed high risk for carotid endarterectomy (CEA) who are indicated for treatment of carotid artery stenosis (CAS), transcarotid artery revascularization (TCAR) has been demonstrated to be a safe and effective alternative to transfemoral CAS. Compared with CEA, in which approximately 12% of patients undergoing awake intervention do not tolerate internal carotid artery clamping, only 1% to 2% of patients were observed to have intolerance to flow reversal during TCAR based on data from the Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER) 1 and 2 trials. This study reviewed awake interventions from those trials to assess factors associated with intolerance to flow reversal and to review how those cases were managed.
Method(s): This is a retrospective review of prospectively collected data from the ROADSTER multicenter trial along with the subsequent postapproval (ROADSTER 2) trial. The subset of patients from both trials undergoing awake TCAR was analyzed to compare demographics, procedural details, and anatomic factors between patients who did and did not experience intolerance to reversal of flow to assess for predisposing factors. Patients were deemed intolerant to flow reversal at the discretion of the operator, often related to changes in completion of neurologic tasks, hemodynamic stability, or patient-reported symptoms.
Result(s): There were 103 patients from ROADSTER and 194 patients from ROADSTER 2 who underwent TCAR under local/regional anesthesia. Of these, eight patients had intolerance to flow reversal, although all cases were successfully completed. Four cases were completed under low-flow reversal, three cases were successfully weaned from low to high flow during several minutes, and one case required general anesthesia. No significant association was found between intolerance to flow reversal and comorbidities including diabetes mellitus, hypertension, hyperlipidemia, congestive heart failure, prior myocardial infarction or angina, preoperative CAS-related symptoms, prior stroke, prior CAS or CEA, prior neck irradiation, tandem stenosis, high cervical stenosis, or hostile neck (Tables I and II). A trend toward significance was seen with chronic obstructive pulmonary disease (P =.086) and contralateral carotid artery occlusion (P =.139).
Conclusion(s): Despite intolerance to flow reversal, most cases were successfully completed by adjusting reversal of flow rate and did not require conversion to general endotracheal anesthesia. Whereas factors contributing to intolerance of flow reversal during TCAR remain poorly understood, this study identified a trend toward significance with an association of pre-existing chronic obstructive pulmonary disease and contralateral carotid artery occlusion. Given the low number of patients who experienced this issue, a larger sample size is required to better elucidate these trends. [Formula presented] [Formula presented]
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EMBASE:2006737413
ISSN: 1097-6809
CID: 4521792
Underutilization of Non Opioid Pain Medication in Patients Undergoing AAA Repair
Phair, John; Carnevale, Matthew; Levine, Dov; Scher, Larry; Shariff, Saadat; Garg, Karan
OBJECTIVES/OBJECTIVE:With increased focus on the opioid crisis, it was our goal to describe rates and risk factors for postoperative use of opioids in patients undergoing AAA repair as well as identify pain modalities that are underutilized. METHODS:We retrospectively analyzed perioperative analgesic prescriptions for endovascular (EVAR) and open AAA repair between 1/1/2010 to 1/1/2018. Patients' baseline opioid use, demographics, and medical comorbidities were obtained. The EVAR group was further subdivided into percutaneous (pEVAR) and cutdown (cEVAR) groups. Primary outcomes were post-operative and discharge pain medication prescriptions. Relative rates of opioid prescribing were obtained through the electronic medical record and normalized into morphine milligram equivalents (MMEs). RESULTS:Of the 128 patients analyzed in the entire cohort, 21.8% (n=28) underwent open repair and 78.12% (n=100) underwent EVAR (46 pEVAR, 54 cEVAR). As expected, open repair had increased post-operative pain reported compared to EVAR (2.67+/-0.75 vs 0.96+/-0.19, p<0.01). Adjunctive epidural reduced post-operative pain for open repair (0.77 +/-0.48 vs 3.50 +/-0.96 p<0.01). EVAR had less post-operative opioid prescriptions as compared to open repair (35.0% vs 77.3%, p<0.01). In the endovascular group, there was no difference between post-operative opioid prescription based on access, pEVAR vs cEVAR (65.8% vs 80.1% p= 0.11). When stratifying patients by number of cutdowns, patients with bilateral cutdown as opposed to a single cutdown received more opioid prescriptions than pEVAR patients (84.44 vs 65.8% p=0.036). Of those receiving opioids, the average MME for open repair was 320.94 mg compared to 28.82 mg for EVAR (p<0.01). Those undergoing percutaneous repair had significantly less MME use during hospitalization compared to femoral cutdown,17+/-3.52mg vs 31.90+/-5.43mg, respectively (p<0.01). NSAIDs, such as ibuprofen and ketorolac, were rarely used in the post-operative period for open or EVAR (8.3% vs 1.1). Percutaneous EVAR patients reported less pain at discharge compared to cEVAR patients (0.18+/-0.12 vs 0.88+/-0.29, p=0.036). Open and EVAR had comparable low rates of NSAID and acetaminophen prescriptions at discharge. Open patients had longer post-operative length of stay compared to EVAR patients (9.82+/-1.27, 3.86+/-0.47, p<0.01). pEVAR had a shorter length of post-operative course compared to cEVAR (3.2+/-0.26 vs 4.12+/-0.30, p<.01). Patients undergoing EVAR with use of pain medications amounting to <20 MME had a significantly shorter length stay. CONCLUSIONS:This single institutional retrospective study evaluated pain prescription patterns for patients undergoing AAA repair. AAA patients are predominantly treated with opioid pain medications with few adjunctive therapies. Intraoperative epidural and pEVAR may aid in decreasing the total MME used, however, the total number of opioid prescribed are similar for pEVAR and cEVAR despite the difference in approach. Clinicians must consider alternative non-opioid based pain management strategies.
PMID: 32442594
ISSN: 1615-5947
CID: 4447112
Protamine sulfate use during tibial bypass does not appear to increase thrombotic events or affect short-term graft patency
Phair, John; Futchko, John; Trestman, Eric B; Carnevale, Matthew; Friedmann, Patricia; Shukla, Harshal; Garg, Karan; Koleilat, Issam
OBJECTIVES/OBJECTIVE:While the use of protamine sulfate as a heparin reversal agent has been extensively reviewed in patients undergoing carotid endarterectomy and coronary artery bypass grafting, there is a lack of literature on protamine's effects on lower extremity bypasses. The purpose of this study was to determine the risk of protamine sulfate dosing after tibial bypass on thrombotic or bleeding events, including early bypass failure. METHODS:We performed a retrospective review of our institutional database for patients undergoing primary distal peripheral bypass from January 2009 through December 2015 (contralateral bypass was considered to be a new primary bypass). Primary endpoints include composite thrombotic events (myocardial infarction, stroke, amputation at 30 days and patency less than 30 days) and composite bleeding events (bleeding or transfusion). RESULTS: = 0.52). CONCLUSIONS:Heparin reversal with protamine sulfate after tibial or peroneal bypass grafting is not associated with higher cardiovascular morbidity, bypass thrombosis, amputation, or mortality. Additionally, there was no statistically significant difference in post-operative bleeding or thrombosis complications for patients who did not receive protamine, although the findings are suggestive of a potential difference in a more adequately powered study. Our results suggest that protamine sulfate is safe for intraoperative use without increased risk of thrombotic complications or early tibial bypass graft failure.
PMID: 32393108
ISSN: 1708-539x
CID: 4437992
Malpractice Litigation for Compartment syndrome
Phair, John; Carnevale, Matthew; Scher, Larry; Garg, Karan
BACKGROUND:The aim of this study was to analyze litigation involving compartment syndrome to identify the causes and outcomes of such malpractice suits. A better understanding of such litigation may provide insight into areas where clinicians may make improvements in the delivery of care. METHODS:Jury verdict reviews from the Westlaw database from January 1, 2010 to January 1, 2018 were reviewed. The search term "compartment syndrome" was used to identify cases and extract data on the specialty of the physician defendant, the demographics of the plaintiff, the allegation, and the verdict. RESULTS:A total of 124 individual cases involving the diagnosis of compartment syndrome were identified. Medical centers or the hospital was included as a defendant in 51.6% of cases. The most frequent physician defendants were orthopedic surgeons (45.96%), and emergency medicine physicians (20.16%), followed by cardiothoracic/vascular surgeons (16.93%). Failure to diagnose was the most frequently cited claim (71.8% of cases). Majority of plaintiffs were males, with a mean age of 36.7 years, suffering injuries an average of 5 years prior to their verdict. Traumatic compartment syndrome of the lower extremity causing nerve damage was the most common complication attributed to failure to diagnose, leading to litigation. Forty cases (32.25%) were found for the plaintiff or settled, with an average award of $1,553,993.66. CONCLUSION/CONCLUSIONS:Our study offers a brief overview of the most common defendants, plaintiffs, and injuries involved in legal disputes involving compartment syndrome. Orthopedic surgeons were most commonly named; however, vascular surgeons may also be involved in these cases due to the large number of cases with associated arterial involvement. A significant percentage of cases were plaintiff verdicts or settled cases. Failure to diagnosis or delay in treatment were the most common causes of malpractice litigation. Compartment syndrome is a clinical diagnosis and requires a high level of suspicion for a timely diagnosis. Lack of objective criteria for diagnosis increase the chances of medical errors and makes it an area vulnerable to litigation.
PMID: 32339693
ISSN: 1615-5947
CID: 4427652
Natural History, Clinical Significance, and the Role of Vascular Referral in the Management of Penetrating Ulcers of the Abdominal Aorta
Rokosh, Rae S; Shah, Noor; Safran, Brent; Kim, Danny C; Maldonado, Thomas S; Sadek, Mikel; Garg, Karan; Jacobowitz, Glenn; Rockman, Caron
OBJECTIVE:MATERIALS AND METHODS: Patients at our tertiary referral center were identified for inclusion based on a search for the term "penetrating ulcer" in abdominal computed tomography and magnetic resonance imaging reports between January 2014 and December 2017. Patients' electronic medical records were retrospectively reviewed to determine baseline medical characteristics, imaging indication, as well as subsequent clinical course, interventions and outcomes. Aortic diameters and ulcer depths were measured by a single observer on initial and follow-up imaging to assess for association with concomitant aortic pathology, evolving aortic disease, and ulcer progression, defined as increase in depth of ≥ 1mm. Statistical analysis was performed using STATA 16 (College Station, TX: StataCorp LLC), and a threshold p-value of < 0.05 set for significance. RESULTS:Ninety-two patients with PUAA were identified; 57 (62%) were male. The mean age at diagnosis was 79.3 years, and comorbidities included hypertension (74%), hyperlipidemia (65%) and malignancy (34%). The most common indication for imaging was chest, back, or abdominal pain (19%). On initial imaging, mean ulcer depth was 1cm (range from 0.2cm to 3.4cm). Concomitant abdominal aortic dilation ≥ 3cm was found in 34 (37%) patients. Thirty-six (39%) patients had a vascular surgery consultation immediately following radiographic diagnosis. Follow-up axial imaging was performed on 27 (29%) untreated patients. The overall sample's mean ulcer depth remained essentially unchanged from initial measurement (p = .99); however, 14 (52%) patients with follow-up imaging were found to have increased overall aortic diameter. Of the total 92 patients, nine (10%) underwent an endovascular abdominal aortic intervention during the review period: two for symptomatic PUAA and the remainder for progression of concomitant aneurysmal disease. All cause mortality was 5% during mean follow-up period of 21.9 months (range 0 to 72.5 months). Of the patients lost to follow-up, 61% did not receive vascular referral after initial diagnosis. CONCLUSIONS:PUAA are typically incidental findings identified in elderly, comorbid patients undergoing imaging for an unrelated indication. Though isolated findings of an asymptomatic PUAA rarely require surgical intervention, these patients we argue would benefit from vascular surgery referral for long-term follow-up and interval imaging to assess for disease progression as well as concomitant aortic degeneration, which may necessitate repair. In addition, we observed that the majority of those patients lost to follow-up did not receive vascular consultation, suggesting that lack of involvement of vascular specialists at the time of diagnosis is a missed opportunity to secure appropriate follow-up and management.
PMID: 32234398
ISSN: 1615-5947
CID: 4370332
Increased ischemic complications in fenestrated and branched endovascular abdominal aortic repair compared with standard endovascular aortic repair
Westin, Gregory G; Rockman, Caron B; Sadek, Mikel; Ramkhelawon, Bhama; Cambria, Matthew R; Silvestro, Michele; Garg, Karan; Cayne, Neal S; Veith, Frank J; Maldonado, Thomas S
OBJECTIVE:Ischemic complications (including in the lower extremity, visceral, spinal, and pelvic territories) following standard endovascular aortic repair (EVAR) are well recognized but fortunately uncommon. The incidence of such complications following fenestrated and branched aortic repair (F/BEVAR) has not been well defined in the literature. The objective of this study was to compare the incidence of ischemic complications between EVAR and F/BEVAR and to elucidate potential risk factors for these complications. METHODS:We identified all patients who underwent EVAR from 2003 to 2017 or F/BEVAR from 2012 to 2017 in the national Vascular Quality Initiative database. We assessed differences in perioperative ischemic outcomes with methods including logistic regression and inverse probability of treatment propensity score weighting, using a composite endpoint of lower extremity ischemia, intestinal ischemia, stroke, or new dialysis as the primary endpoint. RESULTS:The data comprised 35,379 EVAR patients and 3374Â F/BEVAR patients. F/BEVAR patients were more likely to be female, have had previous aneurysm repairs, and be deemed unfit for open aneurysm repair; they were less likely to have ruptured aneurysms; and they had higher estimated blood losses, contrast volumes, and fluoroscopy and procedure times. The incidence of any ischemic event (7.7% vs 2.2%) as well as the incidences of the component endpoints of lower extremity ischemia (2.3% vs 1.0%), intestinal ischemia (2.7% vs 0.7%), stroke (1.5% vs 0.3%), and new hemodialysis (3.1% vs 0.4%) were all significantly increased (all PÂ < .001) in F/BEVAR compared with standard EVAR. After propensity adjustment, F/BEVAR conferred increased odds of any ischemic complication (1.8), intestinal ischemia (2.0), lower extremity ischemia (1.3), new hemodialysis (10.2), and stroke (2.3). CONCLUSIONS:Rates of lower extremity ischemia, intestinal ischemia, new dialysis, and stroke each range from 0% to 1% for standard EVAR and 1% to 3% for F/BEVAR. The incidence of perioperative ischemic complications following F/BEVAR is significantly increased compared to EVAR. The real-world data in this study should help guide decision-making for surgeons and patients as well as serve as one metric for progress in device and technique development. Improvements in ischemic complications may come from continued technology development such as smaller sheaths, improved imaging to decrease procedure time and contrast volume, embolic protection, and increased operator skill with wire and catheter manipulation.
PMID: 32081484
ISSN: 1097-6809
CID: 4312642
Primary Patency of Long-Segment Femoropopliteal Artery Lesions in Patients with Peripheral Arterial Occlusive Disease Treated with Paclitaxel-Eluting Technology
Phair, John; Carnevale, Matthew; Lipsitz, Evan C; Shariff, Saadat; Scher, Larry; Garg, Karan
OBJECTIVE:The aim of this study was to evaluate the performance and predictors of failure of paclitaxel drug-eluting stents and paclitaxel coated balloons in the treatment of long-segment femoropopliteal disease. We report a retrospective cohort analysis of patients treated with paclitaxel eluting stents and paclitaxel coated balloons in lesions >100 mm, which were not included in any of the pivotal trials. METHODS:Ninety-seven patients with peripheral vascular disease (Rutherford III-VI) underwent long-segment (≥100 mm) femoropopliteal paclitaxel eluting stent (DES) implantation or angioplasty with paclitaxel coated balloons (DCB). Patients were followed after their initial procedure for target lesion restenosis, defined as a reduction in lumen diameter by greater than 50% as measured by duplex ultrasonography (ratio>2). RESULTS:The median length of the affected arterial segments was 110 mm (interquartile range [IQR] 100-150, absolute range 100-260) using up to 4 overlapping stents. During the median 13-month follow-up (IQR 7-16), no early thrombotic occlusions occurred within 30 days, but 28 (29%) patients developed a target lesion restenosis after 1 year. Cumulative primary patency at 6 and 12 months was 87% and 71% overall, respectively. The cumulative patency during the same follow-up periods, varied between patients treated with different paclitaxel modalities with 88% and 80% primary patency in patients treated with DES (n=63) versus 81% and 49% in patients treated with DCB (n=21) (adjusted hazard ratio 2.46, p=0.03). Lesion length, concurrent tibial intervention and recurrent target lesions were not associated with restenosis. CONCLUSION/CONCLUSIONS:Short-term outcomes in patients treated with paclitaxel eluting stents and paclitaxel coated balloons in long lesions, mirror results from the clinical trials. The primary patency observed in patients treated with DES was significantly higher than in patients treated with DCBs.
PMID: 31863948
ISSN: 1615-5947
CID: 4243792
Amputation Free Survival in Patients with Critical Limb Ischemia Treated with Paclitaxel-eluting Stents and Paclitaxel-coated Balloons
Phair, John; Carnevale, Matthew; Shariff, Saadat; Scher, Larry; Garg, Karan
OBJECTIVE:The aim of this study was to evaluate the performance of paclitaxel-eluting stents (PES) and paclitaxel-coated balloons (PCB) on amputation free survival in patients with critical limb ischemia (CLI). METHODS:A retrospective review of all patients with Rutherford stage 5 and 6 limb ischemia undergoing endovascular revascularization with paclitaxel related technology, both PES and PCB was carried out over a 4-year period. Clinical grading was determined by Rutherford classification, and the Society for Vascular Surgery's Wound, Ischemia and Foot Infection (WIFi) scoring system. Clinical and angiographic follow-up was reviewed based on intention-to-treat analysis. The primary endpoint of this study was amputation free survival at 12 months. Secondary endpoints included wound healing, freedom from target lesion revascularization and patency of target vessels at 12 months. Follow up occurred at 3, 6 and 12 months post-operatively. Target lesion patency was defined as <50% stenosis, based on a duplex velocity ratio of less than or equal to 2. Post-operative ABI and duplex ultrasound were performed to verify successful treatment. Outcomes were evaluated using Kaplan-Meier and Cox Proportional Hazards models. RESULTS:A total of 88 limbs were revascularized in 88 patients. DES was used as the sole drug technology in 56 patients (60.7% male, median age 70.5 years), DCB was used as the sole drug technology in 32 patients (46.9% male, median age 66 years). Baseline demographics were well matched except for a higher prevalence of occluded target lesions in the DES group (41.1% vs. 12.5%; p=0.004). Limbs were treated for Rutherford stage 5 CLI in 71.6% and stage 6 CLI in 28.4%. Univariate analysis identified no dependent factors affecting limb salvage, except for the use of drug coated balloons. After 12 months of follow up, amputation free survival was significantly higher in the DES group compared to the DCB (88.5% vs. 71.1%; p=0.0443). Wound healing rates after 1 year were also higher in the DES group (83.9% vs. 59.4%; p=0.0198). Freedom from target lesion revascularization was no different between patients treated with DES compared to patients treated with DCB (90.6% vs. 85.7%; p=0.518. Primary patency at 12 months in patients treated with DES was significantly higher than patients treated with PCB (80.4% vs. 58.1%; p=0.0255). CONCLUSIONS:Overall, drug technology represents a viable option for patients with CLI; a cohort not represented in major randomized trials. In our experience, femoropopliteal lesions treated with DES have higher primary patency rates than those treated with DCB. This was found to support higher amputation free survival rates in patients treated with paclitaxel DES compared to paclitaxel DCB. The use of paclitaxel DES for CLI was also associated with significantly improved wound healing compared to DCB. Our data suggests improved outcomes with DES compared to DCB, however, these patients represent a non-randomized, heterogenous group that were treated with the operator's best judgement.
PMID: 31207400
ISSN: 1615-5947
CID: 3938932
Outcomes of Translumbar Embolization of Type II Endoleaks After Endovascular Aneurysm Repair [Meeting Abstract]
Charitable, John F; Patalano, Peter; Jacobowitz, Glenn; Sadek, Mikel; Rockman, Caron; Maldonado, Thomas; Garg, Karan; Cayne, Neal
ORIGINAL:0014656
ISSN: 1097-6809
CID: 4482212