Utility of a Mechanical Thrombectomy Device in Treating Calcified Instent Restenosis Post Iliofemoral Venous Stenting.

Instent restenosis (ISR) following iliofemoral venous stenting is quite common with up to three-quarters of patients developing some degree of ISR. However, only around 16% develop recurrent symptoms impairing their quality-of-life meriting reintervention. The first line of treatment for such ISR involves the use of angioplasty balloons to recreate an adequate flow channel. At times such angioplasty alone is inadequate particularly in the presence of calcified ISR. It is in this setting that the authors decided to explore the utility of a mechanical thrombectomy device to debulk the ISR and thereby help create an adequate flow channel. The successful utilization of such a device in a patient presenting with recurrent, disabling, quality of life impairing symptoms due to ISR represents the focus of this report.

A more proximal landing zone is preferred for thoracic endovascular repair of acute type B aortic dissections.

OBJECTIVE: Thoracic endovascular aortic repair (TEVAR) has become first-line therapy for complicated acute type B aortic dissection (aTBAD). However, the strategy for optimal proximal landing zone remains to be determined. We compared early outcomes and late aortic-related adverse events in patients undergoing TEVAR for complicated aTBAD with endograft deployment in proximal landing zone 2 vs 3. METHODS: We performed a retrospective chart review of adult patients undergoing TEVAR for complicated aTBAD within 6 weeks of diagnosis from January 2008 to December 2018. We excluded patients with connective tissue disorders and prior type A repair. Patients were divided into landing zone 2 TEVAR (Z2T) and zone 3 TEVAR (Z3T) groups. Z2 patients were divided between left subclavian artery (LSA) revascularization (Z2R) vs LSA coverage without revascularization (Z2C). Groups were compared for the need for aortic reintervention within 36 months of initial admission and freedom from aortic-related adverse events and mortality (AREM), defined as the need for aortic reintervention, aortic-related death, or rupture. RESULTS: Eighty-three patients underwent TEVAR for complicated aTBAD within a mean of 4.1 ± 7.8 days; 89.5% of patients had less than 2 cm of healthy proximal descending thoracic aorta. The landing zone was Z3T in 35 patients and 48 underwent Z2T: 10 Z2C and 38 Z2R. There were no differences between Z2T and Z3T in time from diagnosis to TEVAR, demographics, comorbidities, and diameter aortic measurements. The 30-day survival was 87.8%-89.5% for Z2R, 88.6% for Z3, and 80.0% for Z2C (P = .610). The postoperative spinal cord ischemia rate was 3.7%-2.7% for Z2R, 0% for Z3T, and 20.0% for Z2C (P = .012). The postoperative thoracic aortic rupture was 2.2% in Z2 and 0 in Z3. The need for aortic reintervention at 36 months after TEVAR was lower for Z2T (10.4%) vs Z3T (31.4%; P = .025). Freedom from AREM at 36 months was higher in Z2T vs Z3T (87.5% vs 68.6%; P = .048). The freedom from proximal reintervention was higher in Z2T (95.8%) compared with Z3T (80.0%; P = .019). Z3T deployment was predictive for AREM (odd ratio, 3.648; 95% confidence interval, 1.161-11.465; P = .027) and need for proximal reintervention (odds ratio, 5.542; 95% confidence interval, 1.062-28.927; P = .042). CONCLUSIONS: Most patients with aTBAD have less than 2 cm of proximal healthy descending thoracic aorta. In patients treated for complicated aTBAD, Z2T is associated with a lower need for aortic reintervention and aortic-related adverse events than Z3T. Patients may benefit from a more aggressive proximal landing zone with similar perioperative morbidity when Z2T is done with LSA revascularization.

Retrograde use of the Outback re-entry catheter in complex infrainguinal arterial recanalizations.

OBJECTIVE/BACKGROUND: Retrograde recanalizations gained increasing recognition in complex arterial occlusive disease. Re-entry devices are a well-described adjunct for antegrade recanalizations. We present our experience with retrograde, infrainguinal recanalizations using the Outback re-entry catheter in challenging chronic total occlusions. METHODS: We report data from a retrospective multicenter registry in complex retrograde recanalizations. Eligibility criteria included retrograde infrainguinal use of the Outback re-entry catheter where both conventional antegrade and retrograde recanalizations had been unsuccessful. Procedural outcomes included technical success (defined as successful wire passage and delivery of adjunctive therapy with <30% residual stenosis), safety (periprocedural complications, eg, bleeding, vessel injury, or occlusion of the artery at the re-entry site, and distal embolizations), and clinical outcome (amputation-free survival and freedom from clinically driven target lesion revascularization [cd-TLR]). RESULTS: Forty-five consecutive patients underwent retrograde, infrainguinal recanalization attempts with the Outback re-entry catheter between February 2015 and August 2020. Thirty (67%) patients had a history of open vascular surgery in the index limb. In four patients, recanalizations were even more challenging due to previous surgical removal and/or ligation of the proximal segment of the superficial femoral artery. The retrograde access site of the Outback catheter was the femoropopliteal segment in 31 (69%) patients and crural vessels in 14 (31%) patients. The re-entry target sites were as follows: common femoral artery in 31 (69%) patients, superficial femoral artery in 9 (20%) patients, popliteal artery in 1 patient, and below-the-knee arteries in 2 patients. In four patients, the needle of the re-entry device was targeted to an inflated balloon, inserted via the antegrade route. The Outback re-entry catheter was placed via a 6-French sheath in 19 (42%) cases and sheathless in 26 (58%) cases. Technical success was achieved in 41 (91%) patients There were two instances of distal embolizations and three bleeding episodes. Amputation-free survival was 100% at 30 days, and after 12 months, freedom from cd-TLR was 95% at 30 days and 75% at 12 months of follow-up. Female sex was an independent predictor for cd-TLR at 12 months of follow-up. CONCLUSIONS: Retrograde use of the Outback re-entry catheter in infrainguinal chronic total occlusions provides an effective and safe endovascular adjunct, when conventional antegrade and retrograde recanalization attempts have failed.

Propensity score-matched analysis of 1-year outcomes of transcarotid revascularization with dynamic flow reversal, carotid endarterectomy, and transfemoral carotid artery stenting.

OBJECTIVE: Initial studies showed no significant differences in perioperative stroke or death between transcarotid artery revascularization (TCAR) and carotid endarterectomy (CEA) and lower stroke/death rates after TCAR compared with transfemoral carotid artery stenting (TFCAS). This study focuses on the 1-year outcomes of ipsilateral stroke or death after TCAR, CEA, and TFCAS. METHODS: All patients undergoing TCAR, TFCAS, and CEA between September 2016 and December 2019 were identified in the Vascular Quality Initiative (VQI) database. The latest follow-up was September 3, 2020. One-to-one propensity score-matched analysis was performed for patients with available 1-year follow-up data for TCAR vs CEA and for TCAR vs TFCAS. Kaplan-Meier survival and Cox proportional hazard regression analyses were used to evaluate 1-year ipsilateral stroke or death after the three procedures. RESULTS: A total of 41,548 patients underwent CEA, 5725 patients underwent TCAR, and 6064 patients underwent TFCAS during the study period and had recorded 1-year outcomes. The cohorts were well-matched in terms of baseline demographics and comorbidities. Among 4180 TCAR vs CEA matched pairs of patients, there were no significant differences in 30-day stroke, death, and stroke/death. However, TCAR was associated with a lower risk of 30-day stroke/death/myocardial infarction (2.30% vs 3.25%; relative risk, 0.71; 95% confidence interval [CI], 0.55-0.91; P = .008), driven by a lower risk of myocardial infarction (0.55% vs 1.12%; hazard ratio [HR], 0.49; 95% CI, 0.30-0.81; P = .004). At 1 year, no significant difference was observed in the risk of ipsilateral stroke or death (6.49% vs 5.68%; HR, 1.14; 95% CI, 0.95-1.37; P = .157). Among 4036 matched pairs in the TCAR vs TFCAS group, TCAR was also associated with lower risk of perioperative stroke or death compared with TFCAS (1.83% vs 2.55%; HR, 0.72; 95% CI, 0.54-0.96; P = .027). At 1 year, the risks of ipsilateral stroke or death of TCAR and TFCAS were comparable (6.07% vs 7.07%; HR, 0.85; 95% CI, 0.71-1.01; P = .07). Symptomatic status did not modify the association in TCAR vs CEA. However, asymptomatic patients had favorable outcomes with TCAR vs TFCAS at 1 year (HR, 0.78; 95% CI, 0.62-0.98; P = .033). CONCLUSIONS: In this propensity score-matched analysis, no significant differences in ipsilateral stroke/death-free survival were observed between TCAR and CEA or between TCAR and TFCAS. The advantages of TCAR compared with TFCAS seem to be mainly in the perioperative period, which makes it a suitable minimally invasive option for surgically high-risk patients with carotid artery stenosis. Larger studies, with longer follow-up and data on restenosis, are warranted to confirm the mid- and long-term benefits and durability of TCAR.

Toward endovascular treatment of type A aortic dissection with smaller landing zones and more patient eligibility.

OBJECTIVE: Type A or ascending aortic dissection is an acute life-threatening condition with high morbidity and mortality. Open surgery remains the standard of care. The development of minimally invasive endografts for type A aortic dissection (TAAD) will require a detailed understanding of the dissection and aortic root anatomy to determine patient eligibility and optimal device specifications. METHODS: Computed tomography images of TAAD cases at our institution from 2012 to 2019 were identified, and three-dimensional reconstructions were performed using OsiriX, version 10.0 (Pixmeo SARL, Bernex, Switzerland). We analyzed key anatomic structures, including centerline length measurements, ascending aorta and aortic root dimensions, and the location and extent of dissection in relationship to the coronary ostia. RESULTS: A total of 53 patients were identified (mean ± standard deviation age, 60.4 ± 17.1 years; 36 men and 17 women), 46 of whom had undergone surgery for TAAD. Four patients had died within 30 days of surgery. In 47 patients (88.7%), the entry tear was distal to the highest coronary ostium. These cases were retrospectively considered for endovascular intervention using a nonbranched, single endograft stent. The proximal landing zone (LZ) was defined as the distance from the highest coronary ostium to the entry tear. Of the 53 patients, 35 (66.0%) had a proximal LZ length of ≥2.0 cm, 38 (71.7%) had a proximal LZ length of ≥1.5 cm, and 42 (79.2%) had a proximal LZ length of ≥1.0 cm. The median proximal and distal LZ diameters of the sinotubular junction (STJ) and distal ascending aorta regions were 3.29 cm (interquartile range [IQR], 2.73-4.10 cm) and 3.49 cm (IQR, 3.09-3.87 cm, respectively), with a median length from the STJ to the innominate takeoff of 8.08 cm (IQR, 6.96-9.40 cm). The median ascending aorta radius of curvature was 6.48 cm (IQR, 5.27-8.00 cm). Of the 53 patients, 25 (47.2%) could be treated with a straight tube graft with a ≤20% diameter mismatch between the proximal and distal LZs. CONCLUSIONS: Almost 80% of the patients with TAAD had had a proximal LZ of ≥1.0 cm. Of these patients, 47.2% had anatomy amenable for endovascular therapy with a nontapered straight tube graft using commercially available devices. To increase patient eligibility for TAAD endovascular intervention, enhanced precision deployment with an adequate seal in shorter LZs will be required. Our results can serve as a guide for endovascular device specifications designed to treat this devastating condition.

Comparison of Prosthetic and Vein Bypass with Nitinol Stents in Long Femoropopliteal Lesions.

BACKGROUND: Guidelines for the treatment of long femoropopliteal lesions are not based on a high level of evidence and recent randomized controlled trials (RCTs) challenge vein bypass (VBP) as the recommended therapy. This study compared prosthetic (PTFE) bypass, VBP and angioplasty with nitinol stents in long femoropopliteal lesions. METHODS: Pooled data from a RCT and a retrospective database with the same inclusion criteria were analyzed with primary and secondary patency as well as freedom from target lesion revascularization (TLR) as primary endpoints. RESULTS: Between 2016 and 2018 a total of 172 lesions were treated in three groups (PTFE: n = 62, VBP: n = 55, stent: n = 55). Clinical and lesion characteristics were similar with mean lesion lengths between 260 and 279mm. Technical success rate in the stent group was 87%. There were no significant differences between the groups in patency rates, freedom from TLR, limb salvage and survival during 2-year follow-up. The primary patency rates for the PTFE, VBP and stent groups were 50%, 56% and 60% at 2 years. The PTFE group had significantly less complications compared to the other groups and a shorter hospital-stay compared to the VBP group. Clinical improvement was significantly better in the PTFE and VBP group compared to the stent group. CONCLUSIONS: The 2-year results indicate that the role of VBP as the recommended therapy for long femoropopliteal lesions may not be unchallenged due to the similar results in all three groups. Further RCTs are needed to determine the best revascularization modality for long femoropopliteal lesions.

Endovascular management of subclavian-steal syndrome in a patient with post-traumatic dissection of an aberrant right subclavian artery.

BACKGROUND: An aberrant right subclavian artery is the most common congenital anomaly of the aortic arch and may cause symptoms due to aneurysmal dilatation, stenosis or occlusion. We present a case of subclavian-steal syndrome due to post-traumatic dissection of an aberrant right subclavian artery. METHODS AND RESULTS: A 50 year-old man presented with dizziness and fainting episodes after exercising his right arm and a systolic blood pressure gradient of 40 mm Hg between the 2 arms. Suspecting a subclavian steal syndrome, a computed tomography angiography was requested which revealed an aberrant right subclavian artery with a severe stenosis proximal to the ostium of the vertebral artery. Transfemoral digital subtraction angiography showed a local dissection of the aberrant right subclavian artery with late retrograde filling of the ipsilateral vertebral artery. The lesion was successfully treated with primary stent implantation (9 mm x 40 mm, LIFESTAR, BARD). On interrogation, the patient recalled an injury to the right arm after falling off a ladder 10 years earlier, as a possible post-traumatic cause for the dissection. He had an uneventful outcome and is symptom-free 12 months down the line. CONCLUSIONS: The combination of post-traumatic dissection of an aberrant right subclavian artery resulting to subclavian steal syndrome is an extremely rare scenario. Endovascular management is a safe, minimally invasive alternative to open surgery.

Impact of chronic outward force on arterial responses of proximal and distal of long superficial femoral artery stent.

BACKGROUND: Self-expanding nitinol stent (SENS) implantation is commonly oversized in the superficial femoral artery (SFA), and leads to chronic outward force (COF) and in-stent restenosis (ISR). This study aimed to investigate the impact of COF of oversizing SENS on ISR of SFA. METHODS: In patients with implanted SENS in SFA, intimal hyperplasia especially between proximal segment and distal segment was evaluated by quantitative angiography, and the impact of COF on mid-term angiographic outcomes was investigated. In addition, porcine model with implanted SENS was used to evaluate the impact of COF on angiographic and histopathologic outcomes at 1 month. Excised stented arteries were evaluated by histopathologic analysis. RESULTS: We analyzed 65 SENS in 61 patients with follow-up angiography at 6 months to 1 year. The baseline diameter was 6.8 ± 0.71 mm and length were 97.0 ± 33.8 mm for the SENS. The ratio of the diameter of the stent to the reference vessel was 1.3 ± 0.24 at the proximal portion and 1.53 ± 0.27 at the distal portion (P < 0.001). In the long SFA stent, stent-to-vessel ratio was significantly higher in the distal stent than in the proximal stent (1.3 ± 0.2 vs. 1.55 ± 0.25, P = 0.001). ISR incidence was higher at the distal stent (37.3% vs 52.6%, P = 0.029). All 11 pigs survived for 4 weeks after SENS implantation. The vessel diameter was 4.04 ± 0.40 mm (control group) vs 4.45 ± 0.63 mm (oversized group), and the implanted stent diameter was 5.27 ± 0.46 mm vs. 7.18 ± 0.4 mm (P = 0.001). The stent-to-vessel diameter ratio was 1.31 ± 0.12 versus 1.63 ± 0.20 (P < 0.001). After 4 weeks, restenosis % was 29.5 ± 12.9% versus 46.8 ± 21.5% (P = 0.016). The neointimal area was 5.37 ± 1.15 mm2 vs. 8.53 ± 5.18 mm2 (P = 0.05). The restenosis % was 39.34 ± 8.53% versus 63.97 ± 17.1% (P = 0.001). CONCLUSIONS: COF is an important cause of restenosis in the distal portion of the SFA stent. Optimal sizing of the SFA stent is important to reduce the incidence of restenosis. Therefore, COF was an important factor of restenosis following distal SFA stenting.

Feasibility of the Application of Holographic Augmented Reality in Endovascular Surgery Using Microsoft HoloLens Head-Mounted Display.

OBJECTIVES: Advances in virtual, augmented (AR) and mixed reality have led to the development of wearable technologies including head mounted displays (HMD). The aim of this study was to investigate the feasibility to use HMD during endovascular surgery. METHODS: We propose an adaptation of AR-HMD using Microsoft HoloLens. Software was developed to enable visualization of the vascular system during endovascular procedures. A video was performed to present an overview of the device and show its use in real conditions. RESULTS: The device allowed a successful visualization of perioperative angiography during peripheral angioplasty, carotid angioplasty and aortic aneurysm endovascular repair. The device was operated on voice command, preserving the environment sterility. CONCLUSION: This video illustrated the feasibility of the application of holographic AR during endovascular intervention and brings perspectives to use artificial-intelligence derived tools for image-guided surgery.

Parametric Optimization of 3D Printed Hydrogel-Based Cardiovascular Stent.

PURPOSE: This study aimed to develop personalized biodegradable stent (BDS) for the treatment of coronary heart disease. Three-dimensional (3D) printing technique has offered easy and fast fabrication of BDS with enhanced reproducibility and efficacy. METHODS: A variety of BDS were printed with 3 types of hydrogel (~5 ml) resources (10%w/v sodium alginate (SA), 10%w/v cysteine-sodium alginate (SA-CYS), and 10%w/v cysteine-sodium alginate with 0.4%w/v PLA-nanofibers (SA-CYS-NF)) dispersed from an 22G print head nozzle attached to the BD-syringe. The printability of hydrogels into 3D structures was examined based on such variables as hydrogel's viscosity, printing distance, printing speed and the nozzle size. RESULTS: It was demonstrated that alginate composition (10%w/v) offered BDS with sufficient viscosity that defined the thickness and swelling ratio of the stent struts. The thickness of the strut was found to be 338.7 ± 29.3 µm, 262.5 ± 14.7 µm and 237.1 ± 14.7 µm for stents made of SA, SA-CYS and SA-CYS-NF, respectively. SA-CYS-NF stent displayed the highest swelling ratio of 38.8 ± 2.9% at the initial 30 min, whereas stents made of SA and SA-CYS had 23.1 ± 2.4% and 22.0 ± 2.4%, respectively. CONCLUSION: The printed stents had sufficient mechanical strength and were stable against pseudo-physiological wall shear stress. An addition of nanofibers to alginate hydrogel significantly enhanced the biodegradation rates of the stents. In vitro cell culture studies revealed that stents had no cytotoxic effects on human umbilical vein endothelial cells (HUVECs) and Raw 264.7 cells (i.e., Monocyte/macrophage-like cells), supporting that stents are biocompatible and can be explored for future clinical applications.

A systematic review of the ipsilateral retrograde approach to the treatment of femoropopliteal arterial lesions.

OBJECTIVE: The endovascular treatment of femoropopliteal lesions is an integral part of managing peripheral arterial disease. The antegrade approach is the most widely used technique with good evidence for its safety and efficacy. However, crossing a lesion, particularly chronic total occlusions (CTO), can be technically challenging and so the retrograde approach is increasingly used to maximize the chances of procedural success. The objective of this systematic review was, therefore, to assess the safety and effectiveness of the ipsilateral retrograde approach to femoropopliteal lesions. METHODS: A systematic review conforming to the PRISMA standards was undertaken. MEDLINE, EMBASE, and The Cochrane Register were searched between January 1, 1988, and January 1, 2020. Full-text, English-language, peer-reviewed articles pertaining to peripheral arterial disease, endovascular intervention and access site were included. RESULTS: A total of 8599 articles were screened, of which 38, involving 1940 patients undergoing 2184 retrograde procedures, were included. The mean number of patients per study was 51.1, with three studies including fewer than 10 and four more than 100 patients. The reported follow-up ranged from 30 days to 3 years, and six articles did not report any long-term outcome data. A retrograde approach was used as the primary access route in 45.% of procedures (648/1438) with relevant data. Primary technical success was achieved in 88% (1920/2184; 64%-100%) with a reported complication rate of 11% (235/2117; 0%-27%). Overall, the quality of evidence was poor, with just seven articles deemed to be of high quality with a low risk of bias. A meta-analysis was not deemed appropriate owing to heterogeneity of data. CONCLUSIONS: An ipsilateral retrograde approach to femoropopliteal lesions has good primary technical success and a low rate of complications. It has a promising role as a bailout, or even a primary access technique, in complex lesions. Patient positioning, puncture site and technique, lesion anatomy, and the size of catheters and devices used are important considerations to achieve the best outcomes. There remains a paucity of robust evidence for its superiority over traditional antegrade approaches, and further work is required to identify the optimal technique and those patients who would benefit most from the approach.

Long-term outcome of percutaneous transluminal renal angioplasty (PTRA) versus PTRA with stenting (PTRAS) in transplant renal artery stenosis.

BACKGROUND: Endovascular treatment is standard of care for transplant renal artery stenosis (TRAS). No study has evaluated long-term outcomes compared between percutaneous transluminal renal angioplasty (PTRA) and PTRA with stenting (PTRAS). Accordingly, this study aimed to investigate the 1-year clinical success, and short- and long-term event-free survival between PTRA and PTRAS in patients diagnosed with TRAS at Thailand's largest national tertiary referral center. METHODS: This single-center retrospective study included kidney transplant patients treated for TRAS during January 2001 to June 2019. Clinical success was defined as (1) increase in estimated glomerular filtration rate (eGFR) > 15%, or (2) reduction in mean arterial pressure (MAP) > 15% with no decrease in antihypertensive medication, or no reduction in MAP or reduction in MAP < 15% with decrease in antihypertensive medication. Incidence of kidney transplant graft failure and transplant renal artery stenosis were also collected. RESULTS: Sixty-five cases of TRAS were identified from 1072 patients who underwent kidney transplantation. The majority (98.5%) had end-to-side anastomosis technique. Thirty-four patients had PTRA, while 31 patients had PTRAS. One-year clinical success according to renal outcome and BP reduction was 78.5% and 49.2%, respectively. Both renal outcome (79.4% vs. 77.4%, p = 0.845) and BP reduction (40.6% vs. 58.1%, p = 0.166) at 1 year were similar between the PTRA and PTRAS groups. Compared between PTRA and PTRAS, event-free survival for composite of kidney transplant graft failure or transplant renal artery restenosis was significantly higher for PTRAS at 1 year (82.4% vs. 100%, p = 0.025), but not significantly different at 10 years (73.5% vs. 71%, p = 0.818). CONCLUSIONS: We demonstrated the 1-year clinical success, and short- and long-term event-free survival between PTRA and PTRAS in TRAS patients. One-year clinical success was found to be similar between groups. Event-free survival for composite of kidney transplant graft failure or transplant renal artery restenosis was significantly higher in PTRAS at 1 year, but similar between groups at 10 years. Trial registration Thai Clinical Trials Registry, TCTR20200626002. Registered 26 June 2020-Retrospectively registered, http://www.clinicaltrials.in.th/index.php?tp=regtrials&menu=trial search&smenu = fulltext&task = search&task2 = view1&id = 6441.

Endovascular and medical therapy of May-Thurner syndrome: Case series and scoping literature review.

INTRODUCTION: May-Thurner syndrome has been recognized as a cause of chronic venous insufficiency and a trigger for venous thromboembolism. There is no consensus about the definition, diagnosis, and therapeutic approach. We are aiming to describe its characteristics and a scoping literature review. METHODS: A retrospective review of patients with May-Thurner syndrome from March 2010 to May 2018 and scoping literature review were made. RESULTS: Seven patients were identified. All patients were female with a median age of 36 (20-60) years. The median time from the first symptom to diagnosis was 3.41 (0.01-9) years. The primary clinical presentation was post-thrombotic syndrome (4 patients). Six patients had at least one risk factor for deep venous thrombosis. All patients underwent angioplasty with stent; patients with acute deep venous thrombosis, furthermore mechanic thrombectomy with or without catheter-directed thrombolysis were done. There were three complications (one patient, lymphedema, and two venous stent thrombosis). Scoping review results were descriptively summarized. CONCLUSION: May-Thurner syndrome has a varied spectrum of clinical presentation, and clinical awareness is paramount for diagnosis. Its principal complication is the post-thrombotic syndrome, which is associated with high morbidity. There is no consensus on the antithrombotic treatment approach.

Safety and Efficacy of Vacuum Assisted Thrombo-Aspiration in Patients with Acute Lower Limb Ischaemia: The INDIAN Trial.

OBJECTIVE: The aim was to evaluate the short term safety and effectiveness of the Penumbra/Indigo aspiration thrombectomy Systems (Penumbra Inc.) in patients with acute lower limb ischaemia. (ALLI). Recently, endovascular vacuum assisted thrombectomy devices, similar to those used in the management of acute ischaemic stroke, have become available for peripheral arteries, but data are still scarce. METHODS: To assess vessel patency, a modified Thrombolysis in Myocardial Infarction (TIMI) classification, called TIPI (Thrombo-aspiration In Peripheral Ischaemia), is proposed. The TIPI flow is assessed at presentation, immediately after treatment with the study device, and after all adjuvant procedures. The primary outcome is the technical success of the thrombo-aspiration with the investigative system, defined as near complete or complete revascularisation TIPI 2 - 3. Safety and clinical success rate were collected at one month. RESULTS: One hundred and fifty patients were enrolled. The mean age was 72.4 years and 73.3% were male. Rutherford grade on enrolment was I in 16%, IIa in 40.7%, and IIb in 43.3% with a mean ankle brachial index of 0.19. Primary technical success (TIPI 2 - 3 flow) was achieved in 88.7% of patients. Adjunctive procedures included angioplasty/stenting of chronic atherosclerotic lesions (n = 39), thrombolysis (n = 31), covered stenting (n = 15), and supplementary Fogarty embolectomy (n = 6). After all interventions, assisted primary technical success was 95.3% (TIPI 2 - 3 in 143/150). No systemic bleeding complications or device related serious adverse events were reported. At one month follow up, one death, and one below the knee amputation were recorded. Primary patency was 92% (138/150), and the re-intervention rate was 7.33%, resulting in an assisted primary and secondary patency of 94% and 99.33%, respectively. CONCLUSION: Results from the INDIAN registry reveal that mechanical thrombectomy using the Indigo system is safe and effective for revascularisation of ALLI as a primary therapy.

The Outback Re-Entry Device. A Pictorial Review.

The Outback™ Elite re-entry catheter (CORDIS, Cardinal Health, USA) is designed to facilitate placement and positioning of guidewires within the peripheral vasculature and allows for re-entry of a guidewire back into the true lumen of a vessel following a subintimal crossing of an arterial occlusion. The device was first introduced in 2005 and has become widely utilized in a variety of situations involving both arterial and venous interventions. This article aims to share our experiences with the Outback™ device and inform interventionalists of its utility and versatility.

Exploring the rapid expansion of office-based laboratories and peripheral vascular interventions across the United States.

OBJECTIVE: To characterize the relationship between office-based laboratory (OBL) use and Medicare payments for peripheral vascular interventions (PVI). METHODS: Using the Centers for Medicare and Medicaid Services Provider Utilization and Payment Data Public Use Files from 2014 to 2017, we identified providers who performed percutaneous transluminal angioplasty, stent placement, and atherectomy. Procedures were aggregated at the provider and hospital referral region (HRR) level. RESULTS: Between 2014 and 2017, 2641 providers performed 308,247 procedures. The mean payment for OBL stent placement in 2017 was $4383.39, and mean payment for OBL atherectomy was $13,079.63. The change in the mean payment amount varied significantly, from a decrease of $16.97 in HRR 146 to an increase of $43.77 per beneficiary over the study period in HRR 11. The change in the rate of PVI also varied substantially, and moderately correlated with change in payment across HRRs (R2 = 0.40; P < .001). The majority of HRRs experienced an increase in rate of PVI within OBLs, which strongly correlated with changes in payments (R2 = 0.85; P < .001). Furthermore, 85% of the variance in change in payment was explained by increases in OBL atherectomy (P < .001). CONCLUSIONS: A rapid shift into the office setting for PVIs occurred within some HRRs, which was highly geographically variable and was strongly correlated with payments. Policymakers should revisit the current payment structure for OBL use and, in particular atherectomy, to better align the policy with its intended goals.

Safety and Efficacy of Endovascular Treatment of Portal Vein Stenosis in Liver Transplant Recipients: A Systematic Review.

PURPOSE: To evaluate the efficacy of Angioplasty and Stent Placement for the treatment of Portal Vein Stenosis in Liver Transplant Recipients by performing a systematic review. MATERIALS AND METHODS: The PubMed Database was extensively searched for articles describing Portal Vein Stenosis (PVS) as a complication in Liver Transplant (LT) patients. The initial database search yielded 488 unique records published in the PubMed Database, 19 of which were deemed to meet the inclusion criteria. Outcomes were separated into 2 groups (Group A included patients with primary angioplasty, Group B included patients with primary stent placement), and further subdivided into Adult and Pediatric populations. RESULTS: Group A included a total of 282 LT patients with portal vein stenosis. The population was predominantly pediatric (n = 243). Group B included a total of 111 LT patients with portal vein stenosis. This population was predominantly adult (n = 66). Technical success was significantly higher in both Group B pediatric (100%) and adults (97%) compared to Group A (69.5%) and (66.7%) respectively. Re-stenosis rates were significantly lower in Group B pediatric group compared to Group A (2.3% vs 29.7%, χ2 = 13.9; p < 0.001). Overall major (3.1%) and minor complications rates (1.5%) were low. CONCLUSION: Primary stent placement appears to have higher technical success in both populations and lower re-stenosis rates for treatment of PVS in pediatric populations.