Efthymios D. Avgerinos

Contemporary outcomes of endovascular interventions for acute limb ischemia

OBJECTIVE Thrombolysis as a treatment for acute limb ischemia (ALI) has become a first-line therapy based on studies published over 2 decades ago. The purpose of this study was to assess outcomes of patients treated for ALI using contemporary thrombolytic agents and endovascular techniques. METHODS Consecutive patients with ALI of the lower extremities treated between 2005 and 2011 were identified, and their records were retrospectively reviewed. All patients were treated with tissue plasminogen activator delivered via catheter-directed thrombolysis (CDT) and/or pharmacomechanical thrombolysis (PMT), with other adjunctive endovascular or surgical interventions. Procedural success, thrombolysis duration, and 30-day and long-term outcomes were obtained for the whole series and were also compared between the CDT and PMT groups. Limb salvage and survival were assessed using time-to-event methods, including Kaplan-Meier estimation and Cox proportional hazards models. RESULTS A total of 154 limbs were treated in 147 patients presenting with ALI (Rutherford class I, 9.7%; class IIa, 70.1%; class IIb, 20.1%). The mean follow-up was 15.20 months (range, 0.56-56.84 months). Indications for intervention included embolization (14.3%), thrombosed bypass (36.4%), thrombosed stent (26.6%), native artery thrombosis (24.0%), and thrombosed popliteal aneurysm (3.2%). Technical success was achieved in 83.8% of cases, with a 30-day mortality rate of 5.2%. Procedural complications included systemic bleeding (5.2%), access site hematoma (4.5%), acute renal failure (1.9%), and distal embolization (9.7%). The mean runoff score decreased from 13.42 preintervention to 7.43 postintervention. Adjuvant revascularization procedures were required in 89.0% of patients and were endovascular (68.8%), hybrid (9.1%), or open (11.0%). Only 3.2% of patients required a fasciotomy. The overall rate of major amputation was 15.0% (18.1% for CDT only, 11.3% for PMT; P = NS). Predictors of limb loss by Cox proportional hazards models included end-stage renal disease (hazard ratio [HR], 8.563; P < .001) and poor pedal outflow, with an incremental protective effect for improved pedal outflow (HR, 0.205; P < .001 for one pedal outflow vessel; HR, 0.074; P < .001 for ≥ two pedal outflow vessels). Gender, smoking, diabetes, Rutherford score, runoff score, thrombosed popliteal aneurysm, and PMT were not significant predictors of limb loss. The use of PMT was a significant predictor of technical success (odds ratio, 2.67; P = .046). CONCLUSIONS Endovascular therapy with thrombolysis using tissue plasminogen activator remains an effective treatment option for patients presenting with mild or moderate lower extremity ALI, with equal benefit derived with CDT or PMT. Patients with end-stage renal disease or poor pedal outflow have an increased risk of limb loss and may benefit from alternative revascularization strategies.

Comparative effectiveness of endovascular versus surgical revascularization for acute lower extremity ischemia

OBJECTIVE Thrombolysis and open surgical revascularization are current options for the treatment of acute limb ischemia (ALI). Despite the several randomized controlled trials comparing the two options, no single treatment can yet be recommended as a universal initial management of ALI. The purpose of this study was to evaluate contemporary endovascular and surgical revascularization for ALI. METHODS Consecutive patients with ALI treated with endovascular revascularization (ER) or open revascularization (OR) between 2005 and 2011 were identified and reviewed. Procedural success and outcomes were compared between the two groups. Limb salvage and survival were assessed by time-to-event methods, including Kaplan-Meier estimation and competing-risks regression models. RESULTS A total of 154 limbs were treated in 147 patients in the ER group, compared with 326 limbs in 296 patients in the OR group. The mean follow-up was 14 ± 18.5 months. The majority of patients presented with Rutherford II ischemia (83% for OR, 90% for ER). In Rutherford II patients, technical success was achieved in 90.7% of the OR group vs 79.9% of the ER group (P = .002), with amputation rates of 10.0% vs 7.2% (P = .35) at 30 days and 16.3% vs 13.0% (P = .37) at 1 year, respectively. In Rutherford II patients with failed bypass graft, technical success rate was 95.0% (OR) vs 75.0% (ER) (P = .001), whereas the amputation rate was 6.3% vs 15.38% (P = .13) at 30 days and 24.1% vs 23.1% (P = .90) at 1 year, respectively. The overall 30-day mortality rate was 13.2% (OR) and 5.4% (ER) (P = .012). Overall amputation rates were 13.5% (OR) vs 6.5% (ER) at 30 days (P = .023) and 19.6% (OR) vs 13.0% (ER) at 1 year (P = .074). The primary patency rate was 57% (OR) and 51% (ER) at 1 year (P = .74). Predictors of limb loss by life-table analysis included coronary artery disease (hazard ratio [HR], 2.0; P = .007) and Rutherford category III (HR, 19.0; P < .001). Predictors of death by life-table analysis included age (HR, 1.03; P < .001), end-stage renal disease (HR, 7.28; P < .001), cancer (HR, 1.65; P = .005), and chronic obstructive pulmonary disease (HR, 1.61; P = .005). CONCLUSIONS In patients presenting with class II ALI, ER or surgical OR resulted in comparable limb salvage rates. Although technical success is higher with OR for patients presenting with failed bypass grafts, the amputation rates are comparable. Overall mortality rates are significantly higher at 30 days and 1 year in the OR group.

Contemporary outcomes of intact and ruptured visceral artery aneurysms

OBJECTIVE The treatment outcomes of ruptured visceral artery aneurysms (rVAAs) have been sparsely characterized, with no clear comparison between different treatment modalities. The purpose of this paper was to review the perioperative and long-term outcomes of open and endovascular interventions for intact visceral artery aneurysms (iVAAs) and rVAAs. METHODS This was a retrospective review of all treated VAAs at one institution from 2003 to 2013. Patient demographics, aneurysm characteristics, management, and subsequent outcomes (technical success, mortality, reintervention) and complications were recorded. RESULTS The study identified 261 patients; 181 patients were repaired (77 ruptured, 104 intact). Pseudoaneurysms were more common in rVAAs (81.8% vs 35.3% for iVAAs; P < .001). The rVAAs were smaller than the iVAAs (20.7 mm vs 27.5 mm; P = .018), and their most common presentation was abdominal pain; 29.7% were hemodynamically unstable. Endovascular intervention was the initial treatment modality for 67.4% (75.3% for rVAAs, 61.5% for iVAAs). The perioperative complication rate was higher for rVAAs (13.7% vs 1% for iVAAs; P = .003), as was mortality at 30 days (13% vs 0% for iVAAs; P = .001), 1 year (32.5% for rVAAs vs 4.1% for iVAAs; P < .001), and 3 years (36.4% for rVAAs vs 8.3% for iVAAs; P < .001). Lower 30-day mortality was noted with endovascular repair for rVAAs (7.4% vs 28.6% open; P = .025). Predictors of mortality for rVAAs included age (odds ratio, 1.04; P = .002), whereas endovascular repair was protective (odds ratio, 0.43; P = .037). Mean follow-up was 26.2 months, and Kaplan-Meier estimates of survival were higher for iVAAs at 3 years (88% vs 62% for rVAAs; P = .045). The 30-day reintervention rate was higher for rVAAs (7.7% vs 19.5% for iVAAs; P = .019) but was similar between open and endovascular repair (8.2% vs 15%; P = NS). CONCLUSIONS rVAAs have significant mortality. Open and endovascular interventions are equally durable for elective repair of VAAs, but endovascular interventions for rVAAs result in lower morbidity and mortality. Aggressive treatment of pseudoaneurysms is electively recommended at diagnosis regardless of size.

Catheter-directed interventions for acute pulmonary embolism

Acute pulmonary embolism (PE) is a leading cause of cardiovascular mortality. Systemic anticoagulation is the standard of care, and treatment can be escalated in the setting of massive or submassive PE, given the high mortality risk. A secondary consideration for intervention is the prevention of late-onset chronic thromboembolic pulmonary hypertension. Treatment options include systemic thrombolysis, catheter-directed interventions, and surgical thromboembolectomy. Whereas systemic thrombolysis seems to be beneficial in the setting of massive PE, it appears to be associated with a higher rate of major complications compared with catheter-directed thrombolysis as shown in recent randomized trials for submassive PE. The hemodynamic and clinical outcomes continue to be defined to determine the indications for and benefits of intervention. The current review summarizes contemporary evidence on the role and outcomes of catheter-directed therapies in the treatment of acute massive and submassive PE.

Technical and Patient-related Characteristics Associated with Challenging Retrieval of Inferior Vena Cava Filters

OBJECTIVE To identify patient-related and device-specific predictors of challenging and failed inferior vena cava (IVC) filter retrievals. METHODS Retrospective single center review of consecutive retrievable IVC filters placed between 2004 and 2009. Retrieval was defined as challenging when it was unsuccessful owing to reported technical failure or when adjunctive endovascular maneuvers or access sites were recruited. Data regarding patient- and filter-specific information were collected. Logistic regression models were used to identify predictors of the reported outcomes. Statistical significance was set at p < .05. RESULTS Four hundred and one patients underwent retrievable IVC filter placement-the majority indicated for prophylaxis (67%). Two hundred and fifty-nine retrievals were attempted and 237 filters were successfully retrieved (overall retrieval rate: 59.1%). Eleven out of 259 (4.2%) attempts were aborted owing to significant thrombus within the filter and 11 (4.2%) were technically unsuccessful. In 142 patients no attempt for filter retrieval was made-the major reason being physician oversight (44.3%). Thirty-eight out of 248 (15.3%) non-aborted filter retrievals were recorded as challenging. Failed retrievals were predicted by prolonged dwell time (96.9 ± 111.9 vs. 29.5 ± 25.1 days, odds ratio [OR] 1.034, 95% confidence interval [CI] 1.016-1.053, p < .001), therapeutic indication (OR 5.197, 95% CI 1.200-22.511, p = .028), and filter wall apposition (OR 11.857, 95% CI 2.069-67.968, p = .006). Challenging retrievals were predicted by dwell time (51.1 ± 69.8 vs. 29.1 ± 24.5 days, OR 1.017, 95% CI 1.005-1.029, p = .007), filter tilt (OR 2.607, 95% CI 1.045-6.508, p = .040) and filter wall apposition (OR 6.149, 95% CI 2.398-15.763, p = <.001). CONCLUSIONS Physician oversight leads to poor IVC filter retrieval rates. Retrievals can be challenging or fail when the dwell time is >50 days and >90 days, respectively, and when the filter hook apposes the caval wall. Filter tilt increases retrieval difficulty but not failure rates.

Comparative Outcomes of Ultrasound-Assisted Thrombolysis and Standard Catheter-Directed Thrombolysis in the Treatment of Acute Pulmonary Embolism

Objectives: The objective of this study was to compare the outcomes of patients undergoing ultrasound-accelerated thrombolysis (USAT) and standard catheter-directed thrombolysis (CDT) for the treatment of acute pulmonary embolism (PE). Methods: The records of all patients in our institution having undergone CDT or USAT for massive or submassive PE from 2009 to 2014 were retrospectively reviewed. Standard statistical methods were used to compare characteristics and to assess for longitudinal change in outcomes. Results: Sixty-three patients, 27 CDT and 36 USAT, were treated for massive (12.7%) or submassive (87.3%) PE. Of which, 96.8% were treated for bilateral PE. Baseline patient characteristics did not differ between the 2 treatment groups. There was no difference in total dose of lytic administered (CDT: 23.2 ± 13.7 mg; USAT: 27.5 ± 12.9 mg; P = .2). Two patients in the CDT and 1 in the USAT groups required conversion to surgical thrombectomy (CDT: 7.4%; USAT: 2.8%; P = .6). Rates of major and minor bleeding complications (CDT: 11.0%; USAT: 13.9%; P = .8) did not differ significantly between the CDT and USAT groups. Estimated survival at 90 days was 92% for CDT and 93% for USAT and 82% at 1 year for both groups (P = .8). All echocardiographic parameters improved significantly from baseline to 1-year follow-up, but quantitative improvement did not differ between groups. Conclusion: This study suggests no statistical differences in clinical and hemodynamic outcomes or procedural complication rates between USAT and standard CDT for the treatment of acute PE. Prospective studies are needed to further evaluate comparative and cost-effectiveness of different interventions for acute massive and submassive PE.

Noninvasive Arterial Testing in Patients With Diabetes A Guide for Foot and Ankle Surgeons

Background: This study was designed to compare the findings of noninvasive arterial testing in patients with and without diabetic foot pathology. Methods: The ABI (ankle brachial index), TBI (toe brachial index), and great toe pressures were measured in 207 patients. PAD (peripheral artery disease) was defined as an ABI < 0.91 on either extremity or a TBI < 0.7. Results: PAD was identified in 103 of the 207 patients (49.8%), 80 patients with diabetic foot pathology and 23 patients with nondiabetic foot pathology. Although patients with diabetic foot pathology were 1.4 times more likely to have PAD compared to patients without diabetic pathology, this increased risk was not statistically significant (OR 1.41 [95% CI 0.75-2.64], P = .28). Patients with PAD and diabetic foot pathology were 4.9 times more likely to have ischemia (toe pressure < 60 mm Hg) than patients with PAD and nondiabetic foot pathology (OR 4.93 [95% CI 1.35-17.94], P < .05). Patients on dialysis had a 7.3 times increased likelihood of having PAD compared to patients not on dialysis (OR 7.3 [95% CI 1.6-33.6], P < .01). Patients with absent pedal pulses were 4.9 more likely to have PAD than patients with normal pulses (OR 4.9 [95% CI 2.6-9.4], P < .0001). PAD was identified in 97 of 188 patients (51.6%) with peripheral neuropathy compared to 6 of 19 patients (31.5%) without peripheral neuropathy (OR 2.31 [95% CI 0.84-6.33], P = .10). Conclusions: Combining the ABI with TBI improved the ability to diagnose PAD in diabetic patients because the ABI has high specificity (low false positives) and the TBI has high sensitivity (low false negatives). The TBI was more reliable in patients with noncompressible arteries, medial artery calcinosis and/or neuropathy. Due to the relative incompressibility of calcified distal arteries in patients with DM, the ABI may be within normal limits in patients with PAD. This false negative result may lead surgeons to assume that normal perfusion is present. Level of Evidence: Level III, comparative study.

Survival and long-term cardiovascular outcomes after carotid endarterectomy in patients with chronic renal insufficiency.

BACKGROUND Multiple studies have evaluated the perioperative outcomes of patients with chronic renal insufficiency (CRI) undergoing carotid endarterectomy (CEA), generally indicating worse survival and cardiovascular (CV) outcomes, although not consistently and with a paucity of long-term data. The present study addresses the perioperative and long-term impact of CRI on CV events and survival after CEA. METHODS A cohort of consecutive patients treated with CEA between January 1, 2000, and December 31, 2008, was analyzed based on medical records and Social Security Death Index. Estimated glomerular filtration rate (GFR) was assessed at baseline. Renal function was used to divide patients into 3 groups: normal (GFR ≥ 60 mL/min/1.73 m(2)), moderate CRI (GFR, 30-59), and severe CRI (GFR <30). The end points were major coronary events, major cerebrovascular events (any stroke), noncardiac vascular interventions (aortic disease, carotid disease, and critical limb ischemia), and mortality. Subgroup analysis based on the presence of preoperative neurologic symptoms was also performed. Survival analysis and Cox regression models were used to assess the effect of baseline predictors. RESULTS A total of 1,342 CEAs (mean age, 71.2 ± 9.2 years; 55.6% male; 35.3% symptomatic) were performed during the study period with a mean clinical follow-up of 57 months (median, 55; range, 0-155 months). Eight hundred sixty-eight (65%) patients had normal renal function, 414 (31%) had moderate CRI, and 60 (4%) had severe CRI (24 on dialysis). The combined 30-day stroke/death rates for the symptomatic and asymptomatic groups were 3.2% and 1.4% (normal renal function), 5.7% and 2.6% (moderate CRI), and 14.3% and 10.3% (severe CRI), respectively, with the differences being significant only for the severe-CRI group. At 5 years, the severe-CRI group experienced significantly more coronary events (36.9% vs. 16.3%, P < 0.001), more cerebrovascular events (21.6% vs. 6.3%, P < 0.001), and deaths (70.0% vs. 20.3%, P < 0.001), whereas the moderate-CRI group had no significantly different outcomes compared with the normal group, except for mortality (29.8% vs. 20.3%, P < 0.001). After adjusting for all risk factors, severe CRI remained predictive of coronary events (hazard ratio [HR], 2.21; 95% confidence interval [CI], 1.25-3.90; P = 0.007), cerebrovascular events (HR, 3.11; 95% CI, 1.44-6.74; P = 0.004), and mortality (HR, 4.36; 95% CI, 3.00-6.34; P < 0.001). Symptomatology at baseline was predictive of 5-year mortality (HR, 1.43; 95% CI, 1.14-1.81; P = 0.002). The need for noncardiac vascular interventions was equally distributed among all the groups. CONCLUSIONS Severe but not moderate CRI is associated with poor perioperative outcomes and is an independent predictor of CV events and death at 5 years after CEA. The decision to perform CEA in symptomatic and asymptomatic patients with severe CRI should be individualized given the poor reported outcomes.

Novel Biomarkers of Abdominal Aortic Aneurysm Disease: Identifying Gaps and Dispelling Misperceptions

Abdominal aortic aneurysm (AAA) is a prevalent and potentially life-threatening disease. Early detection by screening programs and subsequent surveillance has been shown to be effective at reducing the risk of mortality due to aneurysm rupture. The aim of this review is to summarize the developments in the literature concerning the latest biomarkers (from 2008 to date) and their potential screening and therapeutic values. Our search included human studies in English and found numerous novel biomarkers under research, which were categorized in 6 groups. Most of these studies are either experimental or hampered by their low numbers of patients. We concluded that currently no specific laboratory markers allow screeing for the disease and monitoring its progression or the results of treatment. Further studies and studies in larger patient groups are required in order to validate biomarkers as cost-effective tools in the AAA disease.

Risk Factors for Long-Term Mortality and Amputation after Open and Endovascular Treatment of Acute Limb Ischemia

BACKGROUND Acute limb ischemia (ALI) is a highly morbid and fatal vascular emergency with little known about contemporary, long-term patient outcomes. The goal was to determine predictors of long-term mortality and amputation after open and endovascular treatment of ALI. METHODS A retrospective review of ALI patients at a single institution from 2005 to 2011 was performed to determine the impact of revascularization technique on 5-year mortality and amputation. For each main outcome 2 multivariable models were developed; the first adjusted for preoperative clinical presentation and procedure type, the second also adjusted for postoperative adverse events (AEs). RESULTS A total of 445 limbs in 411 patients were treated for ALI. Interventions included surgical thrombectomy (48%), emergent bypass (18%), and endovascular revascularization (34%). Mean age was 68 ± 15 years, 54% were male, and 23% had cancer. Most patients presented with Rutherford classification IIa (54%) or IIb (39%). The etiology of ALI included embolism (27%), in situ thrombosis (28%), thrombosed bypass grafts (32%), and thrombosed stents (13%). Patients treated with open procedures had significantly more advanced ischemia and higher rates of postoperative respiratory failure, whereas patients undergoing endovascular interventions had higher rates of technical failure. Rates of postprocedural bleeding and cardiac events were similar between both treatments. Excluding Rutherford class III patients (n = 12), overall 5-year mortality was 54% (stratified by treatment, 65% for thrombectomy, 63% for bypass, and 36% for endovascular, P < 0.001); 5-year amputation was 28% (stratified by treatment, 18% for thrombectomy, 27% for bypass, and 17% for endovascular, P = 0.042). Adjusting for comorbidities, patient presentation, AEs, and treatment method, the risk of mortality increased with age (hazard ratio [HR] = 1.04, P < 0.001), female gender (HR = 1.50, P = 0.031), cancer (HR = 2.19, P < 0.001), fasciotomy (HR = 1.69, P = 0.204) in situ thrombosis or embolic etiology (HR = 1.73, P = 0.007), cardiac AEs (HR = 2.25, P < 0.001), respiratory failure (HR = 2.72, P < 0.001), renal failure (HR = 4.70, P < 0.001), and hemorrhagic events (HR = 2.25, P = 0.003). Risk of amputation increased with advanced ischemia (Rutherford IIb compared with IIa, HR = 2.57, P < 0.001), thrombosed bypass etiology (HR = 3.53, P = 0.002), open revascularization (OR; HR = 1.95, P = 0.022), and technical failure of primary intervention (HR = 6.01, P < 0.001). CONCLUSIONS After the treatment of ALI, long-term mortality and amputation rates were greater in patients treated with open techniques; OR patients presented with a higher number of comorbidities and advanced ischemia, while also experiencing a higher rate of major postoperative complications. Overall, mortality rates remained high and were most strongly associated with baseline comorbidities, acuity of presentation, and perioperative AEs, particularly respiratory failure. Comparatively, amputation risk was most highly associated with advanced ischemia, thrombosed bypass, and failure of the initial revascularization procedure.