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The Use of Protamine During Peripheral Vascular Interventions in the Vascular Quality Initiative

Research Abstract

Objectives

Protamine administration was shown to reduce bleeding after carotid surgery, but the role of protamine during peripheral vascular interventions (PVI) remains unknown. This study evaluates the trend and outcomes of protamine use in the Vascular Quality Initiative. Our hypothesis is that the use of protamine is associated with decreased bleeding after PVI.

Methods

Patients undergoing elective PVI in the Vascular Quality Initiative (2016-2020) for peripheral arterial disease were reviewed and use trend for protamine was derived. The characteristics of patients undergoing PVI with and without protamine were compared. After propensity matching based on patient as well as access site and procedural characteristics, the perioperative outcomes of both groups were compared.

Results

A total of 92,120 PVI procedures were reviewed and 29.6% (n = 27,272) received protamine (Table). Protamine use significantly increased during the study period from 5.2% to 22.9%. (Figure). Patients receiving protamine were more likely to be White (78.9% vs 76.6%; P < .001), Hispanic (6.5% vs 5.9%; P = .003), and smokers (80.5% vs 78.4%; P < .001). Patients treated with protamine were more likely to have congestive heart failure (20.5% vs 19.8%; P = .006), chronic obstructive pulmonary disease (28.2% vs 26.5%; P < .001), diabetes mellitus (53.3% vs 54.4%; P = .002), and were more likely to be on aspirin (73.4% vs 73.6%; P = .596), anticoagulants (19.2% vs 18.4%; P = .005), statins (77.4% vs 76.5%; P = .001), and P2Y12 inhibitors (44.3% vs 45%; P = .013). After propensity matching, there was no significant difference in baseline characteristics. There was a significant decrease in bleeding during procedure where protamine was administered compared with no protamine (2% vs 2.2%; P = .032). Protamine was more likely to be given in procedures complicated by perforation (0.75% vs 0.52%; P < .0001) and less likely to be given during procedures with distal embolization (0.4% vs 0.7%; P < .0001). However, patients receiving protamine had significantly higher myocardial infarction (0.5% vs 0.4%; P = .002) and cardiac complications (1.4% vs 1.1%; P < .001). There was no significant difference in mortality between the two groups.

Conclusions

Protamine use is associated with decreased perioperative bleeding but increased cardiac complications. Protamine should be selectively administered to patients at high risk of bleeding during PVI.

Research Authors
Sahar H. Ali1 ∙ Fatma Shebl ∙ Edouard Aboian2 ∙ David Strosberg ∙ Uwe Fischer ∙ Jonathan Cardella ∙ Raul J. Guzman2 ∙ Cassius Iyad Ochoa Chaar2
Research Date
Research Department
Research Journal
Journal of Vascular Surgery
Research Member
Research Year
2022

CO2 Angiography During Peripheral Vascular Interventions Reduces Risk of Postcontrast Acute Kidney Injury and Cardiac Complications in Patients with Advanced Chronic Kidney Disease

Research Abstract

Objectives

Patients with chronic kidney disease (CKD) who undergo peripheral vascular interventions (PVI) with iodinated contrast are at higher risk of postcontrast acute kidney injury (PC-AKI). CO2 angiography can reduce iodinated contrast volume usage in this patient population, but its impact on PC-AKI has not been studied. This article examines the use of CO2 angiography during PVI in the VQI. We hypothesize that CO2 angiography is associated with a decrease in PC-AKI in patients with advanced CKD.

Methods

The Vascular Quality Initiative PVI dataset from 2010 to 2021 was reviewed. Only patients with advanced CKD (estimated glomerular filtration rate of <45 mL/min/1.73 m2) treated for PAD were included. Propensity matching based on demographics, comorbidities, CKD stage, and indications were used to compare the outcomes of patients treated with and without CO2.

Results

There were 20,706 PVIs performed in patients with advanced CKD and only 22% utilized CO2 angiography. Patients who underwent CO2 angiography were younger and less likely to be women or white. However, they were more likely to have more advanced CKD stage, diabetes, and cardiac comorbidities, and be treated for tissue loss compared with patients treated without CO2. Propensity matching yielded 2 well-matched groups with 4396 patients each (Table I). The procedural details after matching demonstrated 50% reduction in the volume of contrast used (32.1 mL vs 63.4 mL; P < .001). PVI with CO2 angiography was associated with lower rates of PC-AKI (3.8% vs 5.1%; P = .01) and cardiac complications (2.1% vs 2.9%; P = .03) without a significant difference in technical failure rates or major/minor amputations (Table II).

Conclusions

CO2 angiography reduces contrast volume usage by 50% during PVI and is associated with decreased cardiac complications and PC-AKI. CO2 angiography is underutilized and should be considered for endovascular treatment of PAD in all patients with advanced CKD.

Research Authors
Shin-Rong Lee ∙ Sahar Ali ∙ Jonathan Cardella ∙ Jeffrey Turner ∙ Raul J. Guzman ∙ Alan Dardik ∙ Cassius Iyad Ochoa Chaar
Research Date
Research Department
Research Journal
Journal of Vascular Surgery
Research Member
Research Year
2022

Clinical Significance of Degree of Iliocaval Obstruction Based on Intravascular Ultrasound Use

Research Abstract

Objective: 

Endovenous therapy serves as the preferred treatment for patients with May–Thurner syndrome (MTS) who have significant symptoms. While stenting for MTS generally yields better results than for postthrombotic syndrome, it remains unclear whether the severity of stenosis specifically in MTS influences these outcomes. This study aims at assessing the effect of the degree of stenosis on endovascular therapy for MTS.

Methods: 

The retrospective study included 73 patients who presented for deep venous stenting of the lower limb at a tertiary center between 2018 and 2022. Based on the intravascular ultrasound (IVUS) use, patients were divided into two groups according to degree of stenosis: 50%–80% and >80% stenosis. Both groups were compared regarding demographics, clinical presentations, procedural details, and postoperative outcomes.

Results: 

Significant >80% stenosis was detected in 45.2% of cases. There was no significant difference regarding demographics and comorbidities except for body mass index (BMI) as patients with >80% stenosis were more likely to have higher BMI (P = 0.05). Patients with >80% stenosis were more likely to have a prior history of DVT (21.2% vs. 5%; P = 0.036). There was no statistical difference in the clinical picture of both groups except for higher rates of active venous ulcer in patients with >80% stenosis (21% vs. 5%: P =0.001). Patients with 50%–80% stenosis were more likely to present with atypical varicosities (50% vs. 21%; P = 0.011). Patients with >80% stenosis were more likely to have venographic features of stenosis as pelvic collateral and ascending lumbar veins (P = 0.0007 and P < 0.0001, respectively). After a mean clinical follow-up of 414.6 ± 587.5, primary patency was higher for the 50%–80% stenosis, 90.9% versus 74.4% (Log-rank test = 0.012).

Conclusion: 

The severity of iliac vein stenosis/compression is associated with more advanced clinical presentations and more venographic signs of collateralizations. IVUS serves as a more sensitive tool than computed tomography venography in detecting left common iliac vein critical stenosis. More than 80% can serve as a proper cutoff point for critical venous stenosis that warrants more aggressive therapy and closer follow-up. A critical degree of stenosis was associated with lower patency rates when compared to 50%–80% stenosis.

Research Authors
Sahar Hamdi Ali, Mostafa Saad Khalil, Ahmed Elbadawy, Hesham Aboloyoun
Research Date
Research Department
Research Journal
Indian Journal of Vascular and Endovascular Surgery
Research Member
Research Year
2024

The Untold Story: Early and Mid-Term Results of Subintimal Angioplasty in Superficial Femoral Artery Versus Popliteal Artery Chronic Total Occlusion

Research Abstract

Objectives:

This study aims to compare the immediate and mid-term outcomes of subintimal angioplasty (SIA) of chronic total occlusions (CTOs) of superficial femoral artery (SFA) versus popliteal artery (PA) and to identify possible predictors of loss of limb-based patency (LBP).

Methods:

This is a retrospective analysis of chronic lower-limb ischemia (CLI) patients (Rutherford classes 3–6) presenting with CTO of SFA or PA treated by SIA and selective stenting in the period 2018 to 2021. Immediate outcomes were compared between the SFA and PA groups, including technical success, perioperative complications, and 30-day major amputation and mortality rates. Mid-term outcomes for technically successful procedures included limb-based patency (LBP), wound healing rate, amputation-free survival (AFS), and major adverse limb events (MALEs).

Results:

A total of 450 CLI patients underwent SIA of CTO at the SFA (n=260, 57.8%) and the PA (n=190, 42.2%). The indication for revascularization was chronic limb-threatening ischemia in 80.8% of SFA group and 84.2% of PA group. Technical success rate was higher in the PA group compared to the SFA group (96.3% vs 91.2%; p=0.03). The 30-day amputation rates were comparable between the SFA and PA groups (7.7% vs 6.8%, p=0.7, respectively). No perioperative mortality or systemic major complications occurred in the present study. Kaplan-Meier estimate of the 1-year rates were significantly better for SFA group regarding LBP (82% for SFA group vs 43% for PA group, p=0.006), AFS (88% vs 64%, p=0.02), and wound healing (79% vs 58%, p=0.027), respectively. The number of runoff vessels was the only factor associated with loss of LBP (hazard ratio [HR], 0.055; 95% confidence interval [CI]: 0.001–3.020, p=0.039).

Conclusions:

Subintimal angioplasty is an effective and safe endovascular treatment option of CTO at SFA and PA with satisfactory immediate outcomes. The mid-term outcomes, however, are better for SFA lesions in terms of improved LBP, AFS, and wound healing rates.

 
Research Authors
Mohammed Shahat, Sahar H Ali, Ahmed N Hussein, Ashraf G Taha, Mohamed AH Taha
Research Date
Research Department
Research Journal
Journal of Endovascular Therapy
Research Member
Research Year
2024

The Incidence and Significance of Iliac Vein Stenosis in Patients with Deep Vein Thrombosis

Research Abstract

Background

The role of iliac vein stenosis (IVS) in the development of deep vein thrombosis (DVT) is poorly understood. This study determines the incidence of IVS in patients diagnosed with DVT and assesses its impact on presentation and outcomes. Our hypothesis is that the presence of IVS increases the risk of long-term ipsilateral DVT recurrence.

Methods

A retrospective study of the electronic medical records of consecutive adult patients treated for lower extremity DVT was performed. Only patients with cross-sectional imaging (computed tomography or magnetic resonance with intravenous contrast) were included. Patient and DVT characteristics were recorded. Cross-sectional imaging was reviewed for the presence or absence of ipsilateral IVS (≥50%). Patients were divided into 2 groups based on the presence or absence of IVS to compare characteristics and outcomes. Subgroup analyses on patients with provoked DVT, cancer-related DVT, and unprovoked DVT were performed.

Results

There were 548 patients with DVT and 32% had evidence of ipsilateral IVS on cross-sectional imaging. There were no significant differences in baseline characteristics or treatment methods between the 2 groups. There was a trend toward patients with IVS having less incidence of pulmonary embolism on presentation (22.9% vs. 29.7%, P = 0.1) but that difference did not reach statistical significance in the overall comparison. Subgroup analysis in patients with cancer-related DVT (n = 227) showed that patients with IVS were significantly more likely to develop ipsilateral recurrent DVT compared to patients with no IVS (12.9% vs. 4.5%, P = 0.045). Patients with unprovoked DVT with IVS had significantly lower pulmonary embolism on presentation than patients with unprovoked DVT without IVS (24.2% vs. 39.8%, P < 0.03).

Conclusions

Ipsilateral ≥50% IVS is present in approximately a third of patients presenting with DVT. The presence of IVS seems to play a differential role in ipsilateral DVT recurrence and prevention of pulmonary embolization in different groups of patients presenting with DVT.

Research Authors
Sahar Ali 1 , Shin Mei Chan 2 , Anand Brahmandam 3 , Yunshan Xu 4 , Yanhong Deng 4 , Ahmed Elbadawy 1 , Alfred Lee 5 , Cassius Iyad Ochoa Chaar 6
Research Date
Research Department
Research Journal
Annals of Vascular Surgery
Research Member
Research Year
2025

The Incidence and Impact of Discordance in Interpretation of Cross-sectional Imaging Between Vascular Specialists and Radiologists in Patients With Deep Venous Stenosis

Research Abstract

Objectives

Intravascular ultrasound (IVUS) is the preferred method for diagnosing iliocaval deep venous stenosis (DVS). Preoperative cross-sectional imaging (CSI) is used to screen for DVS in selected patients, but there is no current standardization of radiological measurement and reporting. Our hypothesis is that discordance in CSI interpretation between vascular specialists and radiologists could impact patient care and outcomes.

Methods

A retrospective analysis of patients who underwent deep venous stenting after CSI for chronic venous symptoms was performed. Vascular specialists reviewed all CSI scans for significant DVS (≥50%) and compared them with the official radiologist reports. Patients were divided into two groups based on the interpretation of CSI: discordant reading (DR) and concordant reading (CR). The DR group consisted of cases where the vascular specialists' interpretation differed from that of the radiologist, whereas the CR group included cases where there was agreement.

Results

Ninety-three patients underwent stenting for DVS with preoperative CSI, and 27% had DR. There were more female patients in the CR group, with no other demographic differences. There were significantly more patients in the CR group with a history of anticoagulation use than patients with DR. There was no difference in presenting symptoms based on CEAP clinical classification between the two groups. MRI was the most used CSI modality (64.5%), with no difference between the groups. There was a significantly higher proportion of patients with common iliac vein (CIV) stenosis in the DR group compared with the CR group reaching up to 96%, suggesting that the interpretation of significant CIV stenosis is the source of most discordances. IVUS revealed significant iliac vein stenosis in the majority of patients (96.8%) regardless of CSI. After a mean follow-up of 2.5 years, both groups had similar symptomatic relief (95% vs 98%; P = .5) (Table) and primary patency (Fig).

Conclusions

This study reveals significant discordance between vascular specialists and radiologists in the interpretation of CSI of DVS related mostly to measurement of the CIV. Even though patients had excellent outcomes in both groups, standardization of measurement and reporting of DVS on CSI could improve patient selection for therapy.

Research Authors
Shreef Said, MD1 ∙ Ying Li, MS2 ∙ Kurt Schultz, MD3 ∙ Sahar Ali, MD4 ∙ Juan Carlos Perez-Lozada, MD1 ∙ Robert Attaran, MD1 ∙ Cassius Iyad Ochoa Chaar, MD
Research Date
Research Department
Research Journal
Journal of Vascular Surgery: Venous and Lymphatic Disorders
Research Member
Research Year
2025

The Utilization of Protamine during Peripheral Vascular Interventions in the VQI

Research Abstract

Background

Protamine administration was shown to reduce bleeding after carotid surgery but the role of protamine during peripheral vascular interventions (PVIs) remains unknown. This study evaluates the trend and outcomes of protamine use in the Vascular Quality Initiative (VQI). Our hypothesis is that the use of protamine is associated with decreased bleeding after PVI.

Methods

Patients undergoing elective PVI in the VQI (2016–2020) for peripheral arterial disease were reviewed and the utilization trend for protamine was described. The characteristics of patients undergoing PVI with and without protamine use were compared. After propensity score matching based on the patient's comorbidities, access site, and procedural characteristics, the perioperative outcomes of both groups were compared using multivariable Poisson regression to estimate adjusted rate ratios (aRRs) and 95% confidence intervals (95% CIs).

Results

The total number of patients was 131,618 and patients who received protamine constituted 29.8% of the sample (N = 38,191). After propensity matching, the total number of patients was 94,582, and patients who received protamine constituted 28.8% of the sample (N = 27,275). Protamine use significantly increased during the study period from 5.2 to 22.9%. Before propensity score matching, patients who received protamine were more likely to be white (79% vs. 76.8, P ≤ 0.001), smokers (80.5% vs. 78.5%, P ≤ 0.001), with medical comorbidities including hypertension (88.9% vs. 88.5%, P = 0.074), congestive heart failure (20.5% vs. 19.8%, P = 0.006), and chronic obstructive pulmonary disease (28.2% vs. 26.5%). They were also more likely to be on perioperative medications such as P2Y12 inhibitors (44.3% vs. 45, P = 0.013%) and statin (77.4% vs. 76.5%, P = 0.001) compared to patients who did not receive protamine. After propensity matching, there were no significant differences between the 2 groups. There was a significant decrease in bleeding during procedures where protamine was administered compared to no protamine (2.0% vs. 2.2%) (aRR, 0.89 [95% CI 0.80, 0.98]). Protamine was more likely to be given in procedures complicated by perforation (0.8% vs. 0.5%) (aRR, 1.48 [95% CI 1.24, 1.76]) and less likely to be given during procedures with distal embolization (0.4% vs. 0.7%) (aRR, 0.59 [95% CI 0.49, 0.73]). However, patients receiving protamine had significantly higher cardiac complications (1.4% vs. 1.1%) (aRR, 1.27 [95% CI 1.12, 1.43]). There was no significant difference in mortality between the 2 groups.

Conclusions

Protamine use is associated with decreased perioperative bleeding but increased cardiac complications. Protamine should be selectively administered to patients at high risk of bleeding during PVI.

Research Authors
Sahar Ali 1 , Fatma M. Shebl 2 , Edouard Aboian 3 , David Strosberg 3 , Uwe Fischer 3 , Jonathan Cardella 3 , Raul J. Guzman 3 , Cassius Iyad Ochoa Chaar 3
Research Date
Research Department
Research Journal
Annals of Vascular Surgery
Research Member
Research Year
2024

Complex pathologies in a patient referred for varicose veins

Research Abstract

Varicose veins are commonly due to saphenous vein reflux, but they can manifest more complex venous pathologies. A 45-year-old woman presented with painful leg varicosities and pelvic pain. Duplex examination showed bilateral superficial venous reflux, and, on further interrogation, cross-sectional imaging demonstrated enlarged ovarian veins and nonthrombotic iliac vein compression. Ovarian vein embolization followed by iliac vein stenting and bilateral lower extremity venous ablations and sclerotherapy was performed. After 5 years, she reports no pelvic symptoms and minimal leg symptoms. This case highlights the complex interplay of these venous pathologies and their successful treatment.

Research Authors
Sahar Ali MD a , Paula Pinto b , Steffen Huber MD c , Juan Carlos Perez-Lozada MD c , Robert Attaran MD d , Cassius Iyad Ochoa Chaar MD, MS b
Research Date
Research Department
Research Journal
Journal of Vascular Surgery Cases, Innovations and Techniques
Research Member
Research Year
2023

Systematic review of venous stent migration to the Heart

Research Abstract

Objective

Venous stent migration to the heart is a potentially life-threatening complication and has recently led to device withdrawal from the market. A review of the literature was conducted to better characterize factors associated with this serious complication and its management.

Methods

A systematic review of the literature using the term “venous stent migration” was performed. All articles describing patients with this complication were reviewed. Patient characteristics, indication, time to discovery of migration, and management were summarized. Venous stents that migrated from the lower body to the heart were compared with venous stents that migrated from the upper body.

Results

A total of 73 papers with 84 patients reported venous stent migration to the heart or through the heart to the pulmonary artery. The number of papers reporting this phenomenon increased from 6 in the period of 1991-1995 to 20 in the period of 2016-2020 (Fig). The incidence of venous stenting migration varied mostly between 0.4% and 4.5%. Patients with migration from lower body were significantly younger (49.1 vs 56.9, P = .05). There were significant differences in indications for stenting with most patients with upper body migration being treated for dialysis access maintenance while patients with lower body migration treated for venous insufficiency/thrombosis (P < .001). Of the cases of venous stent migrations from lower body, 20% (8 of 41) were due to Nutcracker syndrome as an indication. There was no difference in stent characteristics in terms of type (86% self-expanding) or size. The implanted stents were relatively small (mean diameter = 14 mm) and short (mean length = 4.5 mm). After venous stent migration, most patients presented with symptoms (60%), with no difference in mean time to presentation. Patients with upper body stent migration were significantly more likely to be treated with no surgery or endovascular intervention compared with those with lower body stent migration, which was more likely to be treated with an open surgery (P = .014) (Table). At least 12% (n = 3 of 25) of patients requiring open surgery required valve replacement. The overall mortality related to stent migration to the heart was 3.6% (n = 3 of 84).

Conclusions

There is a rise in reporting of venous stent migration to the heart in the literature. Stent migration from the lower body seems to be less amenable to endovascular therapy compared with migration from the upper body. This complication carries significant mortality likely in excess of 3.6% because of underreporting.

Research Authors
Dana Alameddine, Sahar H Ali, Alexandria Brackett, Robert Attaran, Hamid Mojibian, Britt H Tonnessen, Raul J Guzman, Cassius Iyad Ochoa Chaar
Research Date
Research Department
Research Journal
Journal of Vascular Surgery
Research Member
Research Year
2022

Balloon rupture with eversion during innominate vein angioplasty requiring surgical retrieval

Research Abstract

Balloon rupture during angioplasty can with calcified or recalcitrant lesions. A 61-year-old woman presented with worsening arm and facial swelling. She had a history of left upper extremity thrombolysis and stenting of the innominate vein 6 years prior. Venography showed severe in-stent stenosis. After crossing the lesion, a 12-mm balloon was inflated, which ruptured at nominal pressure. The balloon became stuck and could not be moved over the wire even after retraction of the sheath. A limited surgical cutdown was performed, and the balloon and the wire were removed together. The ruptured balloon part was found to be everted and circumferentially wrapped around the wire, preventing the wire exchange. After cutting the everted portion of the balloon, the catheter was removed without losing wire access. A high-pressure balloon was subsequently used to treat the lesion successfully. Her symptoms had resolved on follow-up, and the stent remained patent after 6 months.

Research Authors
Sahar Ali MBBS, MS a b , Shin Rong Lee MD, PhD a , David Strosberg MD, MS, FACS a , Edouard Aboian MD a , Raul Guzman MD a , Cassius Iyad Ochoa Chaar MD, MS, FACS a
Research Date
Research Department
Research Journal
Journal of Vascular Surgery Cases, Innovations and Techniques
Research Member
Research Year
2023
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