Objective Pharmacomechanical thrombolysis (PMT) and catheter-directed thrombolysis (CDT) are commonly used for the treatment of iliofemoral deep venous thrombosis (DVT). The purpose of this study was ...to examine the short- and long-term venous patency and venous valvular function as well as clinical outcomes of patients treated for iliofemoral DVT by PMT and CDT. Methods A retrospective review of all patients with symptomatic DVT treated between 2006 and 2011 with PMT or CDT was performed. All patients were treated by local tissue plasminogen activator delivered with PMT or CDT. Patients were divided into two groups on the basis of initial treatment modality: patients treated by PMT alone (group 1), and those who underwent PMT and CDT or CDT alone (group 2). Group comorbidities, initial presenting symptoms, and Clinical, Etiologic, Anatomic, and Pathologic (CEAP) classification scores were compared. Postprocedural duplex ultrasound was used to assess valve function and treated vein patency rates. At all visits, Villalta and CEAP scores were recorded and compared. Group demographic and procedural results were analyzed by Fisher exact test for dichotomous variables and Kruskal-Wallis equality-of-populations rank test for the ordinal and continuous data. Kaplan-Meier survival estimates were used to assess preserved valve function as well as primary and secondary patency rates. Results There were 79 patients with 102 limbs treated for extensive iliofemoral DVT (median age, 51.5 years; range, 16.6-83.8 years). There were 18 patients in group 1 and 61 patients in group 2 (PMT + CDT n = 54 or CDT alone n = 7). There were no differences in demographics or comorbidities between groups aside from malignant disease, which was more common in group 1 (35.3% vs 11.5%; P = .03). A total of 102 limbs were analyzed, 24 in group 1 and 78 in group 2. Patients in group 1 had a shorter symptom duration compared with group 2 (7 days vs 16 days; P = .011). The median number of procedures in group 1 was lower than in group 2 ( P < .001). At last clinical follow-up, there was no significant difference between the Villalta and CEAP scores or the rate of clinical improvement in symptoms between groups. By Kaplan-Meier analysis, there was no difference in primary patency, secondary patency, and treated valve function at 48 months. Conclusions This study suggests that PMT as a stand-alone therapy is as effective as CDT with or without PMT in preserving valve function and preventing postthrombotic syndrome. Long-term physiologic and functional outcomes are comparable between the modalities, with preserved venous valve function in the majority of patients.
Peripheral arterial disease (PAD) is a common and highly morbid disease. Although there have been recent advancements in the endovascular modalities to treat PAD, comparisons of these strategies, ...especially in the popliteal region, remain underinvestigated. The objective of this study was to compare midterm outcomes in patients with PAD undergoing treatment with both novel and SS compared with drug-coated balloon (DCB) angioplasty.
All patients at a multi-institution health system treated for PAD in the popliteal region from 2011 to 2019 were identified. Presenting features, operative details, and outcomes were included in the analysis. Patients who underwent popliteal revascularization with stents were compared with DCB. SS were compared separately with novel dedicated stents. Two-year primary patency was the primary outcome.
We included 408 patients (72.7 ± 11.8 years old; 57.1% men) in the analysis. There were 221 (54.7%) patients who underwent popliteal stenting and 187 (45.3%) who underwent popliteal DCB. There were high rates of tissue loss in both groups (57.9% vs 50.8%; P = .14). Stented patients had longer lesions (112.4 ± 3.2 vs 100.2 ± 5.8 mm; P = .03) and higher rates of concomitant superficial femoral artery treatment (88.2% vs 39.6%; P < .01). Chronic total occlusions accounted for the majority of lesions treated (stent 62.4%, DCB 64.2%). Perioperative complications were similar between groups. Primary patency for the stented group was higher at two years than the DCB group (61.0% vs 46.1%; P = .03). When evaluating stented patients only, SS had higher 2-year patency than novel stents in the popliteal segment (69.6% vs 51.4%; P = .04). On multivariable analysis, stenosis, as opposed to chronic total occlusion, was associated with improved patency (hazard ratio, 0.49; 95% confidence interval, 0.25-0.96; P = .04), whereas novel stents were associated with worse primary patency (hazard ratio, 2.01; 95% confidence interval, 1.09-3.73; P = .03).
In a population of patients with severe vascular disease, stents do not have inferior patency and limb salvage rates compared with DCB angioplasty when treating the popliteal region. For patients with advanced vascular disease, and especially tissue loss, stents and DCB are both beneficial when treating popliteal lesions.
Drug-coated balloons (DCBs) may increase durability of endovascular treatment of superficial femoral artery (SFA) disease while avoiding stent-related risks. The purpose of this study was to use ...meta-analytic data of DCB studies to compare the cost-effectiveness of potential SFA treatments: DCB, drug-eluting stent (DES), plain old balloon angioplasty (POBA), or bare-metal stent (BMS).
A search for randomized controlled trials comparing DCB with POBA for treatment of SFA disease was performed. Hazard ratios were extracted to account for the time-to-event primary outcome of target lesion revascularization. Odds ratios were calculated for the secondary outcomes of primary patency (PP) and major amputation. Incorporating pooled data from the meta-analysis, cost-effectiveness analysis, assuming a payer perspective, used a decision model to simulate patency at 1 year and 2 years for each index treatment modality: POBA, BMS, DCB, or DES. Costs were based on current Medicare outpatient reimbursement rates.
Eight studies (1352 patients) met inclusion criteria for meta-analysis. DCB outperformed POBA with respect to target lesion revascularization over time (pooled hazard ratio, 0.41; P < .001). Risk of major amputation at 12 months was not significantly different between groups. There was significantly improved 1-year PP in the DCB group compared with POBA (pooled odds ratio, 3.30; P < .001). In the decision model, the highest PP at 1 year was seen in the DES index therapy strategy (79%), followed by DCB (74%), BMS (71%), and POBA (64%). With a baseline cost of $9259.39 per patent limb at 1 year in the POBA-first group, the incremental cost per patent limb for each other strategy compared with POBA was calculated: $14,136.10/additional patent limb for DCB, $38,549.80/limb for DES, and $59,748,85/limb for BMS. The primary BMS option is dominated by being more expensive and less effective than DCB. Compared directly with DCB, DES costs $87,377.20 per additional patent limb at 1 year. Based on the projected PP at 1 year in the decision model, the number needed to treat for DES compared with DCB is 20. At current reimbursement, the use of more than two DCBs per procedure would no longer be cost-effective compared with DES. At 2 years, DCB emerges as the most cost-effective index strategy with the lowest overall cost and highest patency rates over that time horizon.
Current data and reimbursements support the use of DCB as a cost-effective strategy for endovascular intervention in the SFA; any additional effectiveness of DES comes at a high price. Use of more than one DCB per intervention significantly decreases cost-effectiveness.
While the perioperative stroke rate after carotid endarterectomy (CEA) is low, "silent" microinfarctions identified by magnetic resonance imaging (MRI) are common and have been correlated with ...postoperative neurocognitive decline. Our study will investigate the role of remote ischemic preconditioning (RIPC) as a potential neuroprotective mechanism. RIPC is a well-tolerated stimulus that, through neuronal and humoral pathways, generates a systemic environment of greater resistance to subsequent ischemic insults. We hypothesized that patients undergoing RIPC before CEA will have improved postoperative neurocognitive scores compared with those of patients undergoing standard care.
Patients undergoing CEA will be randomized 1:1 to RIPC or standard clinical care. Those randomized to RIPC will undergo a standard protocol of 4 cycles of RIPC. Each RIPC cycle will involve 5 min of forearm ischemia with 5 min of reperfusion. Forearm ischemia will be induced by a blood pressure cuff inflated to 200 mm Hg or at least 15 mm Hg higher than the systolic pressure if it is >185 mm Hg. This will occur after anesthesia induction and during incision/dissection but before manipulation or clamping of the carotid; thus, patients will be blinded to their assignment. Before carotid endarterectomy, all patients will undergo baseline neurocognitive testing in the form of a Montreal Cognitive Assessment (MoCA) and National Institutes of Health (NIH) Toolbox. MoCA testing only will be conducted on postoperative day 1 in the hospital. The full neurocognitive testing battery will again be conducted at 1-month follow-up in the office. Changes from baseline will be compared between arms at the follow-up time points. Assuming no drop-ins or dropouts and a 10% loss to follow-up, we would need a sample size of 43 patients for 80% power per treatment arm. The primary endpoint, change in MoCA scores, will be analyzed using a random effects model, and secondary outcomes will be analyzed using either linear or logistic regression where appropriate.
RIPC, if shown to be effective in protecting patients from neurocognitive decline after CEA, represents a safe, inexpensive, and easily implementable method of neuroprotection.
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