Clinical Outcome of Drug-Eluted Stenting (Zilver PTX) in Patients With Femoropopliteal Occlusive Disease a Single Center Experience.

BACKGROUND: Few industry sponsored trials reported satisfactory outcomes in the use of drug-eluting stents (DES) for treatment of femoropopliteal arterial disease. This study analyzed the early/late clinical outcome from a real world single center. PATIENT POPULATIONS/METHODS: A total of 115 limbs treated with Zilver PTX were analyzed for: major adverse limb event (MALE: above ankle limb amputation/major intervention at 1 year), major adverse events (MAEs; death, amputation, and target lesion thrombosis/reintervention), primary patency (based on duplex ultrasound ± ankle brachial indexes), limb salvage, and amputation free survival rates (AFS) at 1 and 2 years. RESULTS: Indications included claudication in 32% and critical limb threatening ischemia (CLTI) in 68%. Lesions treated included: superficial femoral artery (SFA) 66%, both SFA and popliteal artery (PA) 19% and PA 15%. Mean lesion length was 21 cm and 68% had total occlusion. 45% were Trans-Atlantic Inter-Society Consensus (TASC) TASC II D lesions and 55% A-C lesions. Mean follow-up was 18.4 months (1-76 months). Perioperative major morbidity rate was 8.7% with 0% mortality. MALE rate at 1 year was 17% (13.5% for claudication vs 19.2% for CLTI, p=0.4499). MAE rate was 30% for claudication versus 52% for CLTI (p=0.0392). Overall primary patency rates at 1 and 2 years were 75% and 54% (86% and 71% for claudication vs 70% and 46% for CLTI, respectively, p=0.0213). Primary patency rates at 1 and 2 years were 94% and 88% for TASC A-C lesions versus 50% and 16% for TASC D lesions (p<0.0001). Overall freedom from MALE rate at 1 and 2 years were 85% and 79% (86% and 86% for claudication vs 84% and 74% for CLTI, p=0.2391). These rates were 96% and 93% for TASC A-C lesions versus 70% and 50% for D lesions, respectively (p<0.0001). Limb salvage rates at 1 and 2 years were 93% and 86% (100% and 100% for claudication vs 89% and 78% for CLTI, p=0.012). Overall AFS rates at 1 and 2 years were 79% and 71% (93% and 82% for TASC A-C vs 59% and 59% for D lesions, p=0.001). CONCLUSION: Clinical outcomes after DES (Zilver PTX) in femoropopliteal arterial lesions were satisfactory for TASC A-C lesions but inferior/unsatisfactory for TASC D lesions.

Use of drug-eluting stents in patients with critical limb ischemia and infrapopliteal arterial disease: a real-world single-center experience.

BACKGROUND: Although no drug-eluting stent (DES) has been approved by the Food and Drug Administration to treat infrapopliteal arterial disease, several industry-sponsored trials have reported the outcomes with the use of paclitaxel or sirolimus DESs. To the best of our knowledge, only one study to date has reported on the use of everolimus DESs for infrapopliteal arterial disease. In the present study, we analyzed the clinical outcomes with everolimus DESs in our real-world, single-center experience. METHODS: A total of 107 limbs with critical limb threatening ischemia (98 patients; 118 lesions) treated with DESs (Xience; Abbott Vascular, Santa Clara, Calif) were analyzed. The postoperative early outcomes, major adverse limb events (above the ankle limb amputation or major intervention at 1 year), and major adverse events (death, amputation, target lesion thrombosis or reintervention) were analyzed. Kaplan-Meier analysis was used to estimate the primary patency rates (using duplex ultrasound), amputation-free rates, and amputation-free survival rates. RESULTS: Of the 118 lesions treated, 33% were in the anterior tibial artery, 28% were in the tibioperoneal (TP) artery, 21% were in the posterior tibial artery, 8% were in the peroneal artery, 5% were in the TP/posterior tibial artery, 4% were in the TP artery/PA, and 1% were in the TP/anterior tibial artery. The mean lesion length was 41 mm, and 59% were totally occluded (41% stenotic). The mean follow-up was 18.5 months (range, 1-70 months). The overall postoperative complication rate was 11% (2% major amputations), with 2% mortality. Late symptom improvement of one or more Rutherford category was obtained in 71%. The major adverse events rate at 30 days and 1 year was 12% and 45%, respectively. The major adverse limb events rate at 1 year was 15%. The overall primary patency rate was 42%. The primary patency rate at 1, 2, and 3 years was 57%, 45%, and 33%, respectively. The major amputation-free and overall amputation-free survival rates were 87%, 80%, and 77% and 76%, 65%, and 61% at 1, 2, and 3 years, respectively. CONCLUSIONS: The clinical outcomes after DES (Xience; Abbott Vascular) for infrapopliteal lesions were somewhat satisfactory at 1 year but inferior to the previously reported outcomes, especially at 3 years. Further data with long-term follow-up are needed.

Proposed Algorithm for Treatment of Pulmonary Embolism in COVID-19 Patients.

There is mounting evidence that COVID-19 patients may possess a hypercoagulable profile that increases their risk for thromboembolic complications, including pulmonary embolism (PE). PE has been associated with an increase in morbidity, mortality, prolonged ventilation, and extended ICU admissions. Intervention is warranted in some patients who develop acute massive and submassive PEs. However, the development of PE in COVID-19 patients is often complicated by such factors as delay of diagnosis, confounding medical conditions, and strict isolation precautions. In addition, depleted cardiopulmonary reserve and prone positioning can make management of PE in these patients especially challenging for the physician. In this article, we review current understanding of PE in COVID-19 patients, summarize consensus data regarding the treatment of PE, and propose an algorithm to guide the management of COVID-19 patients with PE.

Achieving a popliteal venous access for renal replacement therapy in critically ill COVID-19 patient in prone position.

This patient is a 67-year-old man who initially presented to our facility with acute respiratory failure secondary to COVID-19. Soon after arrival at our facility, the patient decompensated, developing severe acute respiratory distress syndrome requiring intubation and prone positioning to maintain adequate oxygenation. During the next few days, acute kidney injury with oliguria and severe volume overload developed. The vascular surgery service was consulted to obtain central venous access for emergent continuous renal replacement therapy. On examination, the patient was sedated and paralyzed in a rotating prone-positioning bed. He could not be positioned supine without immediately becoming hypoxic and decompensating. A 50-cm Permcath (Medtronic, Santa Rosa, Calif) was inserted through the left popliteal vein. This case report outlines a possible challenging scenario that the vascular interventionist may encounter in dealing with COVID-19 patients with respiratory compromise in the prone position.

Critical analysis and limitations of resting ankle-brachial index in the diagnosis of symptomatic peripheral arterial disease patients and the role of diabetes mellitus and chronic kidney disease.

BACKGROUND: The ankle-brachial index (ABI) may underestimate the severity of peripheral arterial disease (PAD) in patients with noncompressible vessels. This study analyzed limitations of the ABI and toe-brachial index (TBI), if done alone, in patients with symptomatic PAD, diagnosed by duplex ultrasound (DUS) examination, particularly in patients with diabetes and chronic kidney disease (CKD). METHODS: This is a retrospective review of prospectively collected data. All patients underwent resting ABIs, TBI, and/or DUS. An ABIs of 0.90 or less in either leg was considered abnormal, and the term inconclusive ABIs (noncompressibility) was used if the ABI was 1.3 or greater. The sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy (OA) of ABIs in detecting 50% or greater stenosis of any arterial segment based on DUS were determined. A TBI of less than 0.7 was considered abnormal. RESULTS: We included 2226 ABIs and 1383 DUS examinations: 46% of patients had diabetes, 16% had CKD, and 39% had coronary artery disease. Fifty-three percent of the ABIs were normal, 34% were abnormal, and 13% were inconclusive. For patients with limb-threatening ischemia, 40% had normal ABIs, 40% abnormal ABIs, and 20% were inconclusive. The sensitivity and OA for ABIs in detecting 50% or greater stenosis in the whole series were 57% (95% confidence interval [CI], 53.7-61.2) and 74% (95% CI, 71.9-76.6); for diabetics 51% (95% CI, 46.1-56.3) and 66% (95% CI, 62.3-69.8); nondiabetics 66% (95% CI, 59.9-70.9) and 81% (95% CI, 78.2-83.9). For patients with CKD, the sensitivity and OA for ABIs in detecting 50% or greater stenosis was 43% (95% CI, 34.3-52.7) and 67% (95% CI, 60.2-73.0) versus patients with no CKD 60% (95% CI, 56.3-64.6) and 76% (95% CI, 73.1-78.1). If patients with inconclusive ABIs were excluded, these values were 69% (95% CI, 65.2-72.9) and 80% (95% CI, 77.2-81.9) in the whole series; 67% (95% CI, 61.6-72.7) and 75% (95% CI, 70.5-78.4) for diabetics; and 63% (95% CI, 51.3-73.0) and 78% (95% CI, 70.6-83.9) for patients with CKD. Thirty-three percent of TBIs were normal and 67% were abnormal. The sensitivity and OA for abnormal TBI in detecting 50% or greater stenosis were 85% (95% CI, 78.9-90.0) and 75% (95% CI, 70.1-80.2) in the whole series; 84% (95% CI, 76.0-90.3) and 74% (95% CI, 67.1-80.2) for diabetics; and 77% (95% CI, 61.4-88.2) and 72% (95% CI, 59.9-82.3) for patients with CKD. For those with inconclusive ABIs, these values for TBI were 75% and 69%. CONCLUSIONS: Of symptomatic patients with PAD with 50% or greater stenosis on DUS examination, 43% had normal/inconclusive resting ABIs (49% in diabetics and 57% in CKD). TBI may help in patients with inconclusive ABIs. These patients should undergo further imaging to determine proper treatment.

Clinical outcome of drug-coated balloon angioplasty in patients with femoropopliteal disease: A real-world single-center experience.

BACKGROUND: Several multicenter industry-sponsored clinical trials reported satisfactory results in the use of drug-coated balloons (DCBs) for treatment of femoropopliteal occlusive disease. However, few single-center studies have been published to verify the outcome from real-world experience. METHODS: In this study, 228 patients treated with DCB angioplasty (Lutonix 0.35; Bard, Tempe, Arizona) were analyzed. Perioperative major adverse events (death, amputation, target lesion thrombosis or reintervention) were calculated. Kaplan-Meier analysis was used to estimate primary patency rates (based on duplex ultrasound with or without ankle-brachial index) and limb salvage rates. RESULTS: Lesions treated were primarily TransAtlantic Inter-Society Consensus (TASC) type C and D lesions. Indications included claudication (Rutherford classes 2 and 3) in 40% and critical limb ischemia (CLI; Rutherford classes 4 and 5) in 60%. Lesions treated included 61% in the superficial femoral artery, 15% in the popliteal artery, and 24% in both superficial femoral artery and popliteal artery. Mean follow-up was 12.2 months (range, 1-42 months). Overall perioperative morbidity and mortality rates were 13% and 1%. The perioperative major adverse event rate was 3%. Symptom relief (improvement of one Rutherford category or more) was obtained in 64%. Primary patency rates were 56% and 39% at 1 year and 2 years, respectively. Limb salvage rates were 92% and 83% at 1 year and 2 years. Patients with claudication had a lower rate of early perioperative complications (4% vs 19%; P = .001). Symptom improvement was 76% for claudication vs 49% for CLI (P < .001). Overall, major amputation rate was 0% for claudication vs 13% for CLI (P < .001). The primary patency rates at 1 year and 2 years were 59% and 41% for claudication vs 54% and 37% for CLI (P = .307). The assisted primary patency rates at 1 year and 2 years were 72% and 52% for claudication vs 64% and 46% for CLI (P = .223). Primary patency rates at 1 year and 2 years were 82% and 71% for TASC A to C lesions vs 29% and 14% for TASC D lesions (P < .001). Limb salvage rates at 1 year and 2 years were 100% and 100% for claudication vs 85% and 74% for CLI (P < .001). CONCLUSIONS: Clinical outcomes after DCB angioplasty in femoropopliteal lesions were inferior to what has been reported in previous studies, particularly for TASC D lesions. Further investigation from real-world experience with long-term follow-up is needed to confirm these results.

The incidence of carotid in-stent stenosis is underestimated ≥50% or ≥80% and its clinical implications.

BACKGROUND: The incidence of carotid in-stent stenosis has been reported to vary between 1% and 30%. Most published studies have short follow-up, which may lead to underestimation of the incidence of in-stent stenosis. This study analyzed the incidence of ≥50% and ≥80% in-stent stenosis using validated duplex ultrasound criteria and its clinical implications. METHODS: This is a retrospective analysis of prospectively collected data of 450 carotid artery stenting (CAS) procedures (February 6, 2001-December 19, 2016). All patients had postoperative carotid duplex ultrasound examination, which was repeated at 1 month, 6 months, and every 6 to 12 months thereafter. A Kaplan-Meier analysis was used to estimate rates of freedom from ≥50% in-stent stenosis (internal carotid artery peak systolic velocity of ≥224 cm/s) and ≥80% in-stent stenosis (internal carotid artery peak systolic velocity of ≥325 cm/s), freedom from reintervention, and survival. RESULTS: The mean age was 68.3 years, with a mean follow-up of 40.3 months. A total of 201 patients (45% [201/450]) had CAS for symptomatic disease. Primary CAS was done in 291 patients (65%); in the remaining 35%, CAS was done for postcarotid endarterectomy (CEA) stenosis. A total of 101 patients (23%) had ≥50% late carotid in-stent stenosis, and of these, 33 (7.4%) had ≥80% in-stent stenosis. Nineteen patients (4.3%) developed late transient ischemic attack and three (0.7%) late stroke. Twenty-three (5.2%) patients had late reintervention. Rates of freedom from ≥50% in-stent stenosis in the whole series were 85%, 79%, 75%, 72%, and 70% at 1 year, 2 years, 3 years, 4 years, and 5 years, respectively. The rates of freedom from ≥50% in-stent stenosis for primary CAS and CAS for post-CEA stenosis were not statistically significant (P = .540). The rates of freedom from ≥80% in-stent stenosis for the whole series were 96%, 95%, 93%, 90%, and 89% at 1 year, 2 years, 3 years, 4 years, and 5 years, respectively. The rates of freedom from ≥80% in-stent stenosis for primary CAS and CAS for post-CEA stenosis were also not statistically significant (P = .516). Rates of freedom from reintervention were 98%, 96%, 93%, 93%, and 91% at 1 year, 2 years, 3 years, 4 years, and 5 years, respectively, and there were no significant differences between primary CAS and CAS for post-CEA stenosis (P = .939). The overall late survival rates were 99%, 97%, 96%, 94%, and 91% at 1 year, 2 years, 3 years, 4 years, and 5 years. CONCLUSIONS: The incidence of ≥50% in-stent stenosis is relatively high; however, the rates of ≥80% stenosis and late neurologic events are low. Longer follow-up of patients with ≥50% carotid in-stent stenosis may yield higher incidence of ≥80% stenosis.

Improving Pharmacologic Prevention of VTE in Trauma: IMPACT-IT QI Project.

Enoxaparin regimens commonly used for prophylaxis fail to achieve optimal anti-factor Xa levels in up to 70 per cent of trauma patients. Accordingly, trauma services at the study institution endeavored to develop a standardized approach to optimize pharmacologic prevention with enoxaparin. An enoxaparin venous thromboembolism (VTE) prophylaxis protocol implemented in October 2015 provided weight-adjusted initial dosing parameters with subsequent dose titration to achieve targeted anti-factor Xa levels. Symptomatic VTE rate was evaluated 12 months pre- and post-implementation. Data were obtained from the trauma registry and charts were reviewed from electronic medical records. The rate of symptomatic VTE significantly declined post-implementation (2.0% vs 0.9%, P = 0.009). Enoxaparin use was comparable in these two phases validating that the decline in symptomatic VTEs was not due to an increase in enoxaparin use. Symptomatic VTE rate for patients who received enoxaparin in the post-implementation cohort decreased from 3.2 to 1.0 per cent (P = 0.023, 95% confidence interval = 0.124-0.856). There was also a significant decrease in the rate of symptomatic deep vein thrombosis (2.8% vs 0.9%, P = 0.040, 95% confidence interval = 0.117-0.950). This approach to VTE prophylaxis with enoxaparin resulted in a significant reduction in symptomatic VTE rates. Implementation of similar practices may be equally impactful in other institutions that use enoxaparin.

Anatomical and technical predictors of perioperative clinical outcomes after carotid artery stenting.

BACKGROUND: A few other studies have reported the effects of anatomical and technical factors on clinical outcomes of carotid artery stenting (CAS). This study analyzed the effect of these factors on perioperative stroke/myocardial infarction/death after CAS. METHODS: This was a retrospective analysis of prospectively collected data of 409 of 456 patients who underwent CAS during the study period. A logistic regression analysis was used to determine the effects of anatomical and technical factors on perioperative stroke, death, and myocardial infarction (major adverse events [MAEs]). RESULTS: The MAE rate for the entire series was 4.7% (19 of 409), and the stroke rate was 2.2% (9 of 409). The stroke rate for asymptomatic patients was 0.46% (1 of 218; P = .01). The MAE rates for patients with transient ischemic attack (TIA) were 7% (11 of 158) vs 3.2% (8 of 251) for other indications (P = .077). The stroke rates for heavily calcified lesions were 6.3% (3 of 48) vs 1.2% (4 of 332) for mildly calcified/noncalcified lesions (P = .046). Differences in stroke and MAE rates regarding other anatomical features were not significant. The stroke rate for patients with percutaneous transluminal angioplasty (PTA) before embolic protection device (EPD) insertion was 9.1% (2 of 22) vs 1.8% (7 of 387) for patients without (P = .07) and 2.6% (9 of 341) for patients with poststenting PTA vs 0% (0 of 68) for patients without. The MAE rate for patients with poststenting PTA was 5.6% (19 of 341) vs 0% (0 of 68) for patients without (P = .0536). The MAE rate for patients with the ACCUNET (Abbott, Abbott Park, Ill) EPD was 1.9% (3 of 158) vs 6.7% (16 of 240) for others (P = .029). The differences between stroke and MAE rates for other technical features were not significant. A regression analysis showed that the odds ratio for stroke was 0.1 (P = .031) for asymptomatic indications, 13.7 (P = .014) for TIA indications, 6.1 (P = .0303) for PTA performed before EPD insertion, 1.7 for PTA performed before stenting, and 5.4 (P = .0315) for heavily calcified lesions. The MAE odds ratio was 0.46 (P = .0858) for asymptomatic indications, 2.1 for PTAs performed before EPD insertion, 2.2 for poststent PTAs, and 2.2 (P = .1888) for heavily calcified lesions. A multivariate analysis showed that patients with TIA had an odds ratio of stroke of 11.05 (P = .029). Patients with PTAs performed before EPD insertion had an OR of 6.15 (P = .062). Patients with heavily calcified lesions had an odds ratio of stroke of 4.25 (P = .0871). The MAE odds ratio for ACCUNET vs others was 0.27 (P = .0389). CONCLUSIONS: Calcific lesions and PTA before EPD insertion or after stenting were associated with higher stroke or MAE rates, or both. The ACCUNET EPD was associated with lower MAE rates. There was no correlation between other anatomical/technical variables and CAS outcome.