Dual-pathway inhibition in patients with chronic limb-threatening ischemia requiring reintervention for infrapopliteal occlusions.

Our study aimed to assess the influence of incorporating new oral anticoagulant (NOAC) therapy on clinical outcomes among patients who underwent endovascular intervention for below-the-knee (BTK) occlusions necessitating reintervention. The inclusion criteria encompassed patients with chronic limb-threatening ischemia (CLTI) and had undergone a successful endovascular intervention for BTK artery occlusion, necessitating reintervention. Patients who underwent endovascular interventions for BTK reocclusion were compared to those who received dual-pathway inhibition with NOAC (rivaroxaban 2.5 mg 2 × 1) and clopidogrel (NOAC group), or dual-antiplatelet therapy with clopidogrel and aspirin (DAPT group). The primary endpoints were target vessel reocclusion and target lesion revascularization (TLR) at the 1-year follow-up, while major and minor amputations served as the secondary endpoint. Additionally, a one-year comparison was conducted between the two groups for major bleeding events. 64 patients in our clinic treated with endovascular reintervention (NOAC = 28, DAPT = 34). The TLR rate is 10.7% in NOAC group (N = 3) and 32.4% in DAPT group (N = 11, p = 0.043). The target vessel reocclusion rate is 17.8% in NOAC group (N = 5) and 41.2% in DAPT group (N = 14, p = 0.048). Minor or major amputation rate at 1-year follow-up was 3.6% in NOAC group (N = 1) and 11.7% in DAPT group (N = 4, p = 0.245). The patency rate is significantly higher, and the TLR rate is significantly lower in the NOAC group compared to the DAPT group, with no significant difference in major bleeding between the two groups. Although no statistically significant difference exists in amputation rates, a numerical distinction is evident.

Treatment of complex atherosclerotic femoropopliteal artery disease with a self-expanding interwoven nitinol stent: Midterm results.

OBJECTIVE: To examine the efficacy and durability of an interwoven self-expanding nitinol stent for the treatment of superficial femoral and popliteal arteries. METHOD: Consecutive patients with severely diseased superficial femoral and popliteal arteries who received SUPERA® stents were retrospectively identified.The patients were followed for 12 months by Doppler ultrasound examinations, stent roentgenograms, and estimation of Rutherford-Becker class and ankle-brachial index. RESULTS: From July 2012 to May 2014, 42 limbs in 36 patients (mean age, 61.5 ± 7.5 years; 75% male) were treated with angioplasty and primary stenting. Total occlusions were present in 14 limbs, and 63.8% had either moderate or severe calcification. The mean (±SD) lesion length was 105 mm (±28). Primary patency was 91.4% at 6 months and 85.7% at 12 months. The ankle brachial index increased from 0.57 ± 0.19 preoperative to 0.91 ± 0.12 postoperative. There was no procedural or device-related morbidity or mortality after revascularization and only one major amputation was observed on follow-up. CONCLUSIONS: Our experience shows that, Supera stents are safe and effective in our cohort of patients, with acceptable patency rates. There were no stent fractures so far even with stenting of the femoropopliteal segments. Stent design provides a viable option for high-grade obstructive disease in the femoropopliteal artery.

Chronic Femoropopliteal Occlusions: Comparison of Drug-Eluting Balloon Angioplasty with or without Prior Rotational Thrombectomy.

BACKGROUND: The aim of this study was to compare drug eluting balloon (DEB) angioplasty with and without mechanical thrombectomy system in patients with chronic (> 6 months) femoropopliteal occlusions. METHODS: We retrospectively identified patients from May 2012 to September 2014 at our clinic with severely diseased femoropopliteal arteries treated by endovascular approach with or without adjunctive thrombectomy system. All patients had ankle-brachial index (ABI) measured before and after the intervention, and regular clinical follow-up with Doppler ultrasonography performed at 1 month, 6 months and 1 year. Patients underwent peripheral angiography if needed. RESULTS: Mechanical thrombectomy system (MTS + DEB) was used in 33 patients (31 enrolled 2 patients were lost to follow-up, mean lesion length 149.7mm ± 82.69). The remaining 33 patients were treated without MTS (31 enrolled 2 patients were lost to follow-up DEB N = 31 mean lesion length 157.3 mm ± 92.90). There were 5 restenosis in the MTS + DEB group (83.3% patency rate) and 5 restenosis in the DEB group (82.8% patency rate) at 1 year. The technical success rate was 93.5% in both groups. A statistically significant increase in the ABI (MTS + DEB before 0.47 ± 0.11 vs. after 0.92 ± 0.11 p < 0.01 DEB before 0.47 ± 0.11 vs. after 0.90 ± 0.14 p < 0.01) and improvement in Rutherford staging (p < 0.01) was noted in both groups following intervention. CONCLUSIONS: DEB angioplasty is effective in the treatment of chronic total femoropopliteal occlusions. Combining DEB angioplasty and thrombectomy system does not appear to improve outcomes for treatment of chronic femoropopliteal occlusions.

External iliac artery thrombosis after hypogastric artery ligation and pelvic packing for placenta previa percreta.

Placenta previa percreta is a serious pregnancy condition that may cause massive bleeding. Life-threatening hemorrhage is commonly managed via cesarean hysterectomy or vascular ligations in order to preserve fertility. We present a case of bilateral external iliac artery thrombosis after pelvic compression and uterine devascularization due to placenta previa percreta. The patient had cesarean section due to ultrasonography and magnetic resonance imaging-diagnosed placenta previa percreta, and stated that she preferred a conservative approach rather than hysterectomy in a case of massive bleeding. Spontaneous hemorrhage was recognized during the operation. Pelvic compression and bilateral uterine and internal iliac artery ligations were performed. The left external iliac artery was accidentally held and bonded as the left internal iliac artery, which was turned loose within a minute after distinguishing the vessels. Emergency angiography that was applied because of patient's leg pain showed bilateral external iliac artery thrombosis. Angioplasty was performed by a cardiologist for bilateral occlusions. Placenta invasion abnormalities may be managed by pelvic compression or vascular ligations, which have their own serious complications that the surgeon must manage immediately.

The use of crossing catheters in the recanalization of below-the-knee chronic total occlusions in patients with critical limb ischemia.

BACKGROUND: This study investigates the procedural success of the use of a hydrophilic crossing catheter in the recanalization of below-the-knee artery chronic total occlusions in patients with critical limb ischemia. METHODS: We retrospectively identified below-the knee chronic total occlusion interventions in 30 patients performed between March 2013 and July 2017 in our institute. The inclusion criteria were critical limb ischemia (Rutherford Class 4 or greater) and occlusion of at least one tibial vessel with revascularization performed with the use of a crossing catheter. Primary technical success was defined as placement of a guide wire in the true lumen, past the distal chronic total occlusions cap. RESULTS: Thirty patients underwent 34 procedures, in which 41 lesions were treated with the use of crossing catheters. Nineteen anterior tibial arteries, 18 posterior tibial arteries, and four peroneal arteries were treated. Mean length was 110.2±36 mm and 20 lesions (48.8%) were severely calcified. The primary technical success rate was 80.5%. Recanalization was achieved with a guide wire and crossing catheter in 25 lesions (76%) and with the crossing catheter alone in eight cases (24%). CONCLUSION: The use of a crossing catheter showed a high rate of technical and procedural success in infrapopliteal chronic total occlusions without significant complications.

Endovascular treatment of patients with bilateral internal iliac artery disease and buttock claudication.

BACKGROUND: This study aims to investigate the therapeutic value of endovascular treatment in patients with buttock claudication caused by stenosis or occlusion of the bilateral internal iliac arteries. METHODS: This single-center, retrospective study included a total of 12 patients (9 males, 3 females; mean age 63.7±6.4 years; range 54 to 74 years) with persistent buttock claudication who underwent endovascular repair of bilateral internal iliac artery stenosis or occlusion and were treated with percutaneous transluminal angioplasty in another session at our center between July 2012 and February 2016. The iliac Doppler ultrasonography and/or computed tomography angiography were performed at six and 12 months to evaluate restenosis or occlusion. Symptom relief was considered a successful outcome. RESULTS: The median follow-up was 16.5±3.7 (range, 12 to 24) months. Four patients underwent a bilateral intervention and eight patients underwent unilateral intervention. There was a 100% technical success rate with no complications. The primary patency rate at 12 months was 87.5%. Six patients (50%) had complete and four patients (33.3%) had partial relief of the buttock claudication symptoms. CONCLUSION: Percutaneous angioplasty of the internal iliac arteries is a technically feasible and safe method in patients with buttock claudication and bilateral internal iliac artery occlusion or stenosis. Complete or partial relief of symptoms can be achieved in the majority of patients with a high primary patency rate.

Comparison of drug eluting balloon angioplasty to infrapopliteal artery critical lesions with or without additional pedal artery angioplasty in patients with diabetes mellitus and critical limb ischemia.

BACKGROUND: The purpose of this study is to investigate the feasibility and outcome of balloon angioplasty for the treatment of below the ankle (BTA) lesions in addition to below the knee (BTK) lesions in diabetic patients with critical limb ischemia (CLI). METHODS: Inclusion criteria are diabetes mellitus (DM), CLI (Rutherford class 4 or higher) and revascularized significant stenosis or occlusion of at least 1 below-the-knee vessel with incomplete or no pedal loop. Target BTK vessel restenosis and reocclusion at 1-year follow-up was the primary end point whereas minor or major amputation at 1-year follow-up was the secondary end point. RESULTS: From July 2012 to June 2016, 48 diabetic patients identified with BTK with additionally BTA lesions were identified. Three patients were lost to follow-up, leaving 45 patients. In 20 patients both BTK and BTA lesion (BTA group) was revascularized whereas only BTK lesion was treated in 25 patients (BTK group). The primary end point is 15.8% in BTA group and 47.8% in BTK group (p:0.059; P > 0.05). Minor or major amputation rate at 1-year follow-up was 15.8% in BTA group and 34.8% in BTA group (p:0.190; P > 0.05). CONCLUSION: Our study shows that additional BTA angioplasty to BTK intervention may improve the primary patency rate and have higher event free rate, which slightly missed the margin of statistically significance. RBC decreased significantly more in BTA group compared to BTK group, which reflected that the outcome of intervention is better with additional BTA angioplasty.

Comparison of drug-eluting balloon angioplasty with self-expanding interwoven nitinol stent deployment in patients with complex femoropopliteal lesions.

Objective The aim of this study was to compare the drug-eluting balloon with self-expanding interwoven nitinol stent deployment in patients with complex femoropopliteal lesions. Methods We retrospectively identified patients at our clinic with complex femoropopliteal artery lesions treated either with self-expanding interwoven nitinol stent or drug-eluting balloon. All patients had ankle-brachial index measured before and after the intervention, and regular clinical follow-up with Doppler ultrasonography was performed at six months and one year. Patients underwent peripheral angiography if needed. Results From April 2012 to July 2015, 107 patients with complex femoropopliteal lesions treated with using self-expanding interwoven nitinol stent ( N = 49, mean length 143.5 mm, mean follow-up of 14.1 ± 3.7 months) or drug-eluting balloon ( N = 58, mean length 140.6 mm, mean follow-up of 13.8 ± 4.1 months). The technical success rate was 100% in Supera® and 96.6% in drug-eluting balloon group. There were seven restenosis in self-expanding interwoven nitinol stent (SUS) group (84.8% patency) and 11 restenosis in drug-eluting balloon group (79.2% patency). A significant increase in the ankle-brachial index in both groups after intervention demonstrated a hemodynamic success (SUS group 0.45 ± 0.06, drug-eluting balloon group 0.43 ± 0.07). The mean Rutherford Becker Class significantly decreased in both groups after a follow-up of 12 months (SUS group 0.70 ± 0.73, drug-eluting balloon group 0.74 ± 0.75). Conclusion Deploying drug-eluting balloon or self-expanding interwoven nitinol stent in patients with complex femoropopliteal lesions are both safe and effective with high patency rates with no statistical difference for one-year primary patency rates between them.

In-Hospital and long term results of primary angioplasty and medical therapy in nonagenarian patients with acute myocardial infarction.

Introduction: Although percutaneous coronary intervention is an accepted "first-line" therapy in acute ST elevation myocardial infarction (STEMI) in general population, few data are available on the short- and long-term outcomes of very old patients (age >90 years). Our aim is to evaluate and compare the short and long-term outcomes after primary percutaneous coronary intervention (PPCI) or medical therapy in nonagenarian patients with STEMI. Methods: We retrospectively identified patients older than 90 years old in our clinic, with acute STEMI who presented within 12 hours after symptoms onset, either underwent PPCI or medically treated. In hospital events and long-term results analyzed subsequently. Results: From January 2005 to December 2014, 73 patients with STEMI either underwent PPCI (PPCI group n = 42) or had only medical treatment (Non-PPCI group n = 31). Mean age was 92.4 ± 3.1 (90-106). Patients were followed 26.5 ± 20.1 months. Recurrent myocardial infarction during hospitalization was not observed in both groups. In-hospital mortality, cerebrovascular events and acute renal failure rate were similar between two groups (respectively P = 0.797 and P = 1.000, P = 0.288), whereas arrhythmia was significantly higher in the PPCI group ( 0; 21.4%, P = 0.009). Results show re-infarction was similar in both groups (respectively 3.2%; 11.9%, P = 0.382) but mortality in long-term was significantly lower in the PPCI group (respectively 40.9%; 12.9%, P = 0.02). Conclusion: In nonagenarian patients, with STEMI mortality is very high. Although; in-hospital events were similar, the long-term mortality rate was significantly lower in patients treated with PPCI.

Treatment of infrainguinal arterial thromboembolic acute occlusions with the Aspirex® mechanical thrombectomy device.

OBJECTIVE: In this study, we investigated the safety and effectiveness of the Aspirex® mechanical thrombectomy system for the treatment of acute infrainguinal arterial thromboembolic occlusions. METHODS: We retrospectively identified consecutive patients at our clinic with infrainguinal thromboembolic acute occlusions treated with the Aspirex® mechanical thrombectomy device. Primary end points included technical success, defined as the complete revascularization of the acutely occluded vessel, and clinical success, defined as the absence of amputation within 60 d. Secondary end points included 1-year embolized vessel primary patency. RESULTS: Twenty-four patients with infrainguinal arterial acute thromboembolic occlusions were treated with the mechanical thrombectomy system (five infrapopliteal, 12 femoropopliteal and seven popliteal). Technical success occurred in 18 patients (75%), and clinical success occurred in 24 (100%). The 1-year embolized vessel primary patency rate was 75% (n = 18). The 1-year limb salvage rate was 95.8% (n = 23). CONCLUSIONS: The use of the Aspirex® mechanical thrombectomy is effective for the management of acute thromboembolic occlusions of infrainguinal arteries. Caution is needed when using it in smaller vessels, particularly distally below the knee.

Drug-Eluting Balloon Angioplasty for Below the Knee Lesions in End Stage Renal Disease Patients with Critical Limb Ischemia: Midterm Results.

BACKGROUND: The 1-year restenosis rate after standard balloon angioplasty (BA) of long lesions in below-the-knee arteries may be as high as 70%. Our aim was to investigate the efficacy and safety of paclitaxel drug-eluting balloon (DEB) for treatment of below the knee lesions in end stage renal disease patients (ESRD) with critical limb ischemia (CLI). METHODS: Our study is a retrospective, single-center study. Inclusion criteria were ESRD, critical limb ischemia (Rutherford class 4 or higher) and significant stenosis or occlusion of at least 1 below-the-knee vessel. Target vessel restenosis and reocclusion at 1-year follow-up was the primary end point. Major amputation, was the secondary end point. RESULTS: From July 2012 to February 2015, 50 patients identified with ESRD, with CLI, treated with DEB angioplasty. Six patients were lost to follow-up, leaving 44 patients with 55 vessels (mean age, 58.0 ± 6.9 years; 54.5% male). The mean lesion length was 113.4 ± 55.4 mm. BA confined to the infra-popliteal segment alone in 81.8% of cases. Primary patency was 90.4% at 6 months and 62.2% at 12 months. At a mean follow-up of 13.9 ± 3.5 months all cause mortality was 8.1% (N = 3). The ankle brachial index increased from 0.45 ± 0.04 preoperative to 0.88 ± 0.07 postoperative. There was one major amputation (2.7%) and 5 minor amputations at one year (13.5%). CONCLUSION: DEB is effective in the treatment of below the knee critical stenosis and occlusions in ESRD patients with critical limb ischemia.

Thrombus aspiration during primary percutaneous coronary intervention associated with reduced platelet activation.

OBJECTIVES: To determine the effect of thrombectomy on platelet function in patients undergoing primary percutaneous coronary intervention (PPCI) for ST segment elevation myocardial infarction (STEMI). METHODS: This retrospective study included 413 consecutive STEMI patients who underwent PPCI between March 2012 and September 2013 at Kartal Kosuyolu High Specialty Education and Research Hospital, Istanbul, Turkey that were assigned to the thrombus aspiration (TA) group or the non-TA group. Platelet count and mean platelet volume (MPV) were obtained at baseline and 24 hours (h), 48 h, and 72 h post PPCI. RESULTS: Baseline MPV was similar in both groups, whereas the baseline platelet count was higher in the TA group (p=0.42 and p=0.002). The platelet count was higher in the TA group 24 h post PPCI (p=0.02), but was similar in both groups 48 h and 72 h post PPCI (p=0.18 and p=0.07). The MPV 48 h and 72 h post PPCI was higher in the non-TA group than in the TA group (8.4 ± 1.3 fL versus 8.7 ± 1.6 fL [p=0.04] and 8.5 ± 1.1 fL versus 8.9 ± 1.5 fL [p=0.04]). CONCLUSION: Thrombectomy reduced platelet activity via removal of thrombi from the coronary arteries in patients undergoing PPCI for STEMI.

Efficacy of rotational thrombectomy on the mortality of patients with massive and submassive pulmonary embolism.

BACKGROUND: Pulmonary embolism (PE) associated with hemodynamic instability has exceedingly high mortality. We describe our experience using percutaneous mechanical thrombectomy (PMT) in patients with massive PE (MPE) and submassive PE (SPE). METHODS: Thirty-six patients (16 males and 20 females; mean age, 51.4 ± 6.6 years) with massive and submassive PE were treated with PMT. All patients exhibited acute symptoms and computed tomography evidence of large thrombus burden and evidence of right ventricular (RV) dysfunction and/or failure. An Aspirex® percutaneous aspiration device was used in all patients. Clinical outcomes, hemodynamic recovery, RV and pulmonary artery pressures (PAP), blood gas changes, thrombus clearance, and complications were evaluated. RESULTS: Treatment of 36 patients resulted in complete thrombus clearance (≥ 90%) in 83.3% of the patients (n = 30) and near-complete (50% to 90%) clearance in 13.8%. Measurements before and after treatment showed a decrease in mean PAP (53 ± 5.8 mmHg versus 25.6 ± 6.3 mmHg in MPE group [p < 0.01] and 46 ± 7.7 versus 22 ± 3.6 in SPE group [p < 0.01]). One patient died from refractory shock. No cardiovascular deaths or recurrent PE were documented during clinical follow-up but one patient demonstrated evidence of mild cor pulmonale. CONCLUSIONS: This study demonstrates safety and effectiveness of percutaneous mechanical aspiration thrombectomy in patients with massive and submassive PE with a large thrombus burden.

Percutaneous aspiration thrombectomy in treatment of massive pulmonary embolism.

BACKGROUND: Pulmonary embolism (PE) associated with haemodynamic instability has exceedingly high mortality. We describe our experience using percutaneous mechanical thrombectomy (PMT) in patients with massive PE and right ventricle dysfunction. METHODS: Sixteen patients (11 males and five females; mean age, 55.7 ± 8.3 years) with massive PE were treated with PMT. A percutaneous Aspiration Device (8 French Aspirex® aspiration thrombectomy catheter, Straub Medical, Switzerland) was used in all patients. Clinical outcomes, right ventricle and pulmonary artery pressures (PAP), thrombus clearance and complications were evaluated. RESULTS: Treatment of 16 patients resulted in complete thrombus clearance (≥ 90%), in 87.5% of the patients and near-complete (50%-90%) clearance in 6.3%. Measurements before and after treatment showed a decrease in PAP (73 ± 11 mm Hg to 34 ± 8 mm Hg, P<.001). The RV/LV ratio decreased from 1.32 ± 0.15 to 0.84 ± 0.13 at follow-up (P<.001). One patient died from refractory shock. No cardiovascular deaths or recurrent PE were documented during clinical follow-up but one patient demonstrated evidence of mild cor pulmonale. CONCLUSIONS: This study demonstrates safety and effectiveness of percutaneous mechanical aspiration thrombectomy in patients with massive PE with a large thrombus burden.

Improvements in pulmonary artery pressure and right ventricular function after ultrasound-accelerated catheter-directed thrombolysis for the treatment of pulmonary embolism.

OBJECTIVE: To evaluate the efficacy of ultrasound-accelerated catheter-directed thrombolysis (UACDT) in the treatment of patients with massive and submassive pulmonary embolism (PE). METHOD: Twenty-two patients (13 males and nine females; age range, 38 to 71 years; mean age, 53.7 years) with massive or submassive PE were treated with UACDT with the EKOS EkoSonic® system. All patients exhibited acute symptoms, computed tomography (CT) evidence of large thrombus burden, and evidence of right ventricular (RV) dysfunction and/or failure. Clinical outcomes and complications, RV pressures, and thrombus clearance were evaluated. RESULTS: Treatment of 22 patients resulted in complete thrombus clearance (≥90%) in 77.2% of the patients, and near-complete (50% to 90%) clearance in 22.8%. The median tissue plasminogen activator (tPA) dose for all patients in our study was 21.0 mg (range 16 to 35 mg) and the median infusion time was 20.5 hours (range 12 to 28 hours). Measurements before and after treatment showed a decrease in pulmonary artery pressure (67 ± 14 to 34 ± 11 mmHg [systolic], p < 0.001). The RV/LV ratio decreased from 1.29 ± 0.17 to 0.92 ± 0.11 at follow-up (p < 0.001). Modified Miller score was significantly reduced (from 28 ± 4 to 13 ± 5, p < 0.001) in 21 of 22 (95%) patients who survived to discharge. There were only two minor access site bleeding complications, neither requiring transfusion. CONCLUSION: This study demonstrates safety and effectiveness of UACDT in patients with acute PE with a large thrombus burden.