Venovo Venous Stent in Treating Iliac Vein Compression: A Single-Center Experience.

BACKGROUND: The Venovo venous stent (BD/Bard Peripheral Vascular) is indicated to treat iliofemoral veno-occlusive disease. We present our own experience with the Venovo venous stent in treating iliac vein compression (ILVC). METHODS: In this retrospective cohort, we included consecutive patients treated with the Venovo venous stent for ILVC at our center. Stent deployment and sizing were guided by intravascular ultrasound (IVUS). Minimal luminal areas at the compression before and after treatment were measured by IVUS. Clinical improvement was determined by symptoms reported by patients and the Clinical Etiologic Anatomic and Pathophysiologic (CEAP) score. The primary safety endpoint was freedom from acute venothromboembolic disease, stent migration, perforation, acute/subacute closure, and vascular complications. The primary safety endpoint was target-lesion revascularization at 1 year. RESULTS: A total of 50 consecutive patients (57 Venovo stents, 36 women, mean age, 59.8 ± 16.3 years) were included. IVUS-measured mean percent stenosis at the compression site was 64.8% ± 12.8%. Mean total stent length and diameter were 78.0 ± 54.0 mm and 17.1 ± 1.9 mm, respectively. The primary safety endpoint was met in all subjects. Procedural technical success was 100% (successful deployment with no complications). At 1 year, 83.8% of patients reported improvement in their symptoms. Freedom from total occlusion at 1 year was 100% (data available for n = 30 patients). Target-lesion revascularization (TLR) was 2% at 1 year due to 1 patient who had stent explantation from worsening ipsilateral left leg and back pain. CONCLUSION: In this single-center experience, the Venovo venous stent was safe and effective in treating ILVC with 98% freedom from TLR at a follow-up of 1 year. Improvement in symptoms was reported in the majority of patients.

Two-Year Outcomes of Endovascular Interventions of the Common Femoral Artery: A Retrospective Analysis From Two Medical Centers.

BACKGROUND: Treatment of common femoral artery (CFA) disease has been traditionally surgical. Recent data indicate that an endovascular option is feasible in treating CFA disease but there remains significant controversy about the endovascular versus surgical approach to treatment. Newer modalities of therapy have emerged to treat the CFA including atherectomy and drug coated balloons. We retrospectively reviewed data on the long-term outcome of endovascular treatment of CFA from 2 medical centers. METHODS: Consecutive patients with CFA disease treated by 6 operators using endovascular techniques from January 1, 2012 to December 31, 2017 were reviewed and analyzed. Two-year follow up was completed using medical records. Demographic, clinical, procedural and angiographic variables were collected. The primary endpoint of the study was target lesion revascularization (TLR). Secondary endpoints included target vessel revascularization (TVR), mortality, unplanned major and minor amputations and 30-day periprocedural adverse events. Descriptive analysis was performed on all variables. Kaplan-Meier for freedom from TLR was plotted. The study was approved by the Ethics Committee at our center. RESULTS: A total of 89 patients (116 limbs) were included at Index. There were males 57.3%, diabetics 42.7%. Mean age was 65.1 ± 16.3 years. Critical limb ischemia (CLI) was present in 27.7%. Disease distribution was classified by the Medina classification: 1-0-0 (CFA only) 48.3%, 1-0-1 (CFA + profunda) 6.9%, 1-1-1 (CFA+ profunda + origin of superficial femoral artery) 16.4%, 1-1-0 (CFA and origin of SFA) 28.4%. Denovo disease was present in 70.7%. Atherectomy was used in 104/116 limbs (89.7%). Drug coated balloons (DCB) in 15.5%, and stenting in 22.4%. Baseline stenosis 81.2 ± 13.1%, lesion length was 42.0 ± 14.5 mm. Final stenosis was 13.3 ± 11.0. Major bleeding occurred in 2.6%. At 2-year mortality was 9.0% (none related to procedure), CLI was 5.9% and no unplanned major or minor amputations. At 2-year KM analysis showed a probability of freedom from TLR of 72.2%. At 2-year the following TLRs were noted for various devices used: PTA 50%, orbital atherectomy 0%, jetstream 29.2%, laser 36.4%, and SilverHawk/TurboHawk 23.1% (p = 0.0476). CONCLUSION: Endovascular treatment of CFA predominantly with atherectomy in this cohort, is feasible and with acceptable outcomes considering a low percentage of DCB use. A randomized trial is needed to validate these findings and explore the added role of DCB and atherectomy on clinical outcomes when compared to endarterectomy.

An Overview of the Treatment of Symptomatic Common Femoral Artery Lesions with a Focus on Endovascular Therapy.

Endarterectomy of common femoral artery lesions (CFA) carries favorable long-term results and is currently still considered the gold standard for treating these lesions. Although routine stenting has been considered an option for treating the CFA, it has yielded conflicting results and is currently reserved for a bailout of suboptimal endovascular results. Newer therapies with atherectomy or lithoplasty in conjunction with pharmacologic anti-proliferative therapies are promising with less bailout stenting and dissections but randomized trials are needed to confirm their effectiveness and safety.

A Meta-Analysis Comparing Percutaneous Coronary Intervention With Drug-Eluting Stents Versus Coronary Artery Bypass Grafting in Unprotected Left Main Disease.

Coronary artery bypass grafting (CABG) is the preferred revascularization strategy for unprotected left main disease (UPLMD). Multiple small-scale trials and registry data showed that percutaneous coronary intervention (PCI) with drug-eluting stents (DES) is a noninferior strategy with a Class IIa American College of Cardiology/American Heart Association recommendation in patients with high surgical risk and favorable anatomy. However, 2 recent large-scale randomized trials showed conflicting evidence. We conducted a meta-analysis of the existing data to compare outcomes of PCI with DES versus CABG for UPLMD. Four randomized and 8 nonrandomized trials involving 10,284 patients were included. Primary end point was composite of death, stroke, or myocardial infarction (MI) at 3 years or longer. Secondary end points were MACCE (Major Adverse Cardiac and Cerebrovascular Events) and its individual components (death, stroke, MI, or repeat revascularization). Mantel-Haenszel random effects model was used to calculate combined odds ratio for outcomes. A separate analysis of randomized data was also performed. There was no significant difference in primary composite outcome between PCI and CABG. However, MACCE was significantly higher in PCI, primarily driven by significantly high repeat revascularization. A subgroup analysis stratified by Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) score showed that MACCE and repeat revascularization were not significantly different between PCI and CABG in low to intermediate SYNTAX score (<33), whereas they were significantly higher in PCI with higher SYNTAX score. Thus, although CABG remains the preferred method of treatment in UPLMD, PCI with DES can be considered as a reasonable alternative in patients with favorable anatomy and high surgical risk.

Predictors of common femoral artery access site complications in patients on oral anticoagulants and undergoing a coronary procedure.

BACKGROUND: It is unclear whether patients on oral anticoagulants (OAC) undergoing a procedure using common femoral artery access have higher adverse events when compared to patients who are not anticoagulated at the time of the procedure. METHODS: We retrospectively reviewed data from consecutive patients who underwent a cardiac procedure at a tertiary medical center. Patients were considered (group A) fully or partially anticoagulated if they had an international normalized ratio (INR) ≥1.6 on the day of the procedure or were on warfarin or new OAC within 48 h and 24 h of the procedure, respectively. The nonanticoagulated group (group B) had an INR <1.6 or had stopped their warfarin and new OAC >48 h and >24 h preprocedure, respectively. The index primary end point of the study was defined as the composite end point of major bleeding, vascular complications, or cardiovascular-related death during index hospitalization. The 30-day primary end point was defined as the occurrence of the index primary end point and up to 30 days postprocedure. RESULTS: A total of 779 patients were included in this study. Of these patients, 27 (3.5%) patients were in group A. The index primary end point was met in 11/779 (1.4%) patients. The 30-day primary composite end point was met in 18/779 (2.3%) patients. There was no difference in the primary end point at index between group A (1/27 [3.7%]) and group B (10/752 [1.3%]; P=0.3155) and no difference in the 30-day primary composite end point between group A (2/27 [7.4%]) and group B (16/752 [2.1%]; P=0.1313). Multivariable analysis showed that a low creatinine clearance (odds ratio [OR] =0.56; P=0.0200) and underweight patients (<60 kg; OR =3.94; P=0.0300) were independent predictors of the 30-day primary composite end point but not oral anticoagulation (P=0.1500). CONCLUSION: Patients on OAC did not have higher 30-day major adverse events than those who were not anticoagulated at index procedure.