Background Endovascular treatment of below-the-knee disease in chronic limb-threatening ischemia remains challenging, with limited durability of balloon angioplasty and constraints associated with permanent metallic implants. Drug-eluting resorbable scaffolds (DRS) provide temporary vessel support with local drug delivery followed by bioresorption, representing a promising alternative. However, the optimal clinical scenarios for DRS use remain undefined. This study aimed to establish consensus on DRS use in infrapopliteal revascularization. Methods A multidisciplinary steering committee developed a structured questionnaire addressing lesion characteristics, patient-level clinical factors, and health-system considerations. Using the RAND/UCLA Appropriateness Method and a modified Delphi process, 114 clinical scenarios were evaluated by an international panel of experts in vascular surgery, interventional cardiology, interventional radiology, and vascular medicine. Experts rated each scenario using a 5-point Likert scale. Consensus strength was defined as strong (>80% agreement), partial (60% to 80%), or absent (<60%). Results Thirty-five international experts completed the survey. Strong consensus was achieved for 44 scenarios (38.6%), partial consensus for 35 (30.7%), and no consensus for 35 (30.7%). Strong agreement supported DRS use in patients with CLTI (Rutherford 4-6), vessel diameter ≥3 mm, lesions ≤60 mm, and following adequate vessel preparation, particularly in centers with high procedural expertise and advanced imaging capabilities. Partial consensus emerged for longer or moderately complex lesions and certain clinical contexts. Lack of consensus was observed in small-vessel disease, complex bifurcations, long-segment disease requiring multiple scaffolds, thrombotic lesions, and scenarios involving interruption of antiplatelet therapy. Conclusions This consensus defines appropriate clinical scenarios for BTK DRS use, while areas of disagreement identify evidence gaps and research priorities as scaffold technologies evolve.
OBJECTIVE:To evaluate clinical outcomes and duplex ultrasound changes following venous arterialisation (VA) in patients with no option chronic limb threatening ischaemia (CLTI). METHODS:A retrospective analysis was conducted on 23 patients with no option CLTI who underwent VA procedures with standardised pedal duplex ultrasound assessments at baseline, one week, three months, and six months. Pedal venous maturation (PVM) was defined as the presence of dilated terminal pedal veins with a colour Doppler signal and arterialised waveforms. PVM was correlated with VA patency, wound healing, and amputation free survival. RESULTS:At six months, amputation free survival was 85%; three patients underwent below knee amputation and one was lost to follow up. PVM developed in the lateral plantar vein of 86% (19 of 22) of patients at a mean of 112.5 ± 60.6 days (range 5 - 225 days). Once present, PVM persisted in 100% (19 of 19) of cases, including ten patients with VA occlusion. Wound healing occurred in 86% (19 of 22) of patients, including 100% (19 of 19) of those with PVM (p < .001). Healing was minor in 14% and major in 73%. All three patients who ultimately required amputation (at a mean of 152.7 ± 7 days) failed to achieve PVM. In contrast, 100% of patients with PVM remained amputation free at six months (p < .001). CONCLUSION:PVM strongly correlated with wound healing and limb preservation following VA in patients with no option CLTI. PVM may serve as a physiological marker for successful revascularisation and guide post-procedure surveillance strategies.
Background Among patients with chronic limb-threatening ischemia (CLTI) and infrapopliteal artery disease, angioplasty has been associated with frequent reintervention and adverse limb outcomes from restenosis. The effect of the use of drug-eluting resorbable scaffolds on these outcomes remains unknown. Methods In this multicenter, randomized, controlled trial, 261 patients with CLTI and infrapopliteal artery disease were randomly assigned in a 2:1 ratio to receive treatment with an everolimus-eluting resorbable scaffold or angioplasty. The primary efficacy end point was freedom from the following events at 1 year: amputation above the ankle of the target limb, occlusion of the target vessel, clinically driven revascularization of the target lesion, and binary restenosis of the target lesion. The primary safety end point was freedom from major adverse limb events at 6 months and from perioperative death. Results The primary efficacy end point was observed (i.e., no events occurred) in 135 of 173 patients in the scaffold group and 48 of 88 patients in the angioplasty group (Kaplan-Meier estimate, 74% vs. 44%; absolute difference, 30 percentage points; 95% confidence interval [CI], 15 to 46; one-sided P<0.001 for superiority). The primary safety end point was observed in 165 of 170 patients in the scaffold group and 90 of 90 patients in the angioplasty group (absolute difference, -3 percentage points; 95% CI, -6 to 0; one-sided P<0.001 for noninferiority). Serious adverse events related to the index procedure occurred in 2% of the patients in the scaffold group and 3% of those in the angioplasty group. Conclusions Among patients with CLTI due to infrapopliteal artery disease, the use of an everolimus-eluting resorbable scaffold was superior to angioplasty with respect to the primary efficacy end point.
BACKGROUND:Revascularization is the primary treatment modality for chronic limb-threatening ischaemia (CLTI), but is not feasible in all patients. PLX-PAD is an off-the-shelf, placental-derived, mesenchymal stromal cell-like cell therapy. This study aimed to evaluate whether PLX-PAD would increase amputation-free survival in people with CLTI who were not candidates for revascularization. METHODS:People with CLTI and minor tissue loss (Rutherford 5) who were unsuitable for revascularization were entered into a randomized, parallel-group, placebo-controlled, multinational, blinded, trial, in which PLX-PAD was compared with placebo (2 : 1 randomization), with 30 intramuscular injections (0.5 ml each) into the index leg on days 0 and 60. Planned follow-up was 12-36 months, and included vital status, amputations, lesion size, pain and quality-of-life assessments, haemodynamic parameters, and adverse events. RESULTS:Of 213 patients enrolled, 143 were randomized to PLX-PAD and 70 to placebo. Demographics and baseline characteristics were balanced. Most patients were Caucasian (96.2%), male (76.1%), and ambulatory (85.9%). Most patients (76.6%) reported at least one adverse event, which were mostly expected events in CLTI, such as skin ulcer or gangrene. The probability of major amputation or death was similar for placebo and PLX-PAD (33 and 28.6% respectively; HR 0.93, 95% c.i. 0.53 to 1.63; P = 0.788). Revascularization and complete wound healing rates were similar in the two groups. A post hoc analysis of a subpopulation of 121 patients with a baseline haemoglobin A1c level below 6.5% showed improved 12-month amputation-free survival (HR 0.46, 0.21 to 0.99; P = 0.048). CONCLUSION:Although there was no evidence that PLX-PAD reduced amputation-free survival in the entire study population, benefit was observed in patients without diabetes mellitus or whose diabetes was well controlled; this requires confirmation in further studies. Trial registration: NCT03006770 (http://www.clinicaltrials.gov); 2015-005532-18 (EudraCT Clinical Trials register - Search for 2015-005532-18).
ObjectiveTo compare the efficacy of percutaneous deep venous arterialization in no-option chronic limb-threatening ischemia patients in the hospital versus office-based laboratory setting.MethodsA retrospective chart review was performed of all patients who underwent percutaneous deep venous arterialization using off-the-shelf devices from January 2018 to March 2023 in a hospital and an office-based laboratory. 73 eligible patients were identified, 41 hospital (59% male, median age (interquartile range) of 72 (18) years) and 32 office-based laboratory (59% males, 67 (16) years) patients. All eligible patients were deemed to have “no-option” critical limb ischemia, had at least 1 patent proximal tibial artery available for creation of the arteriovenous anastomosis, and were classified as having Rutherford category 4 or higher peripheral arterial disease. Patients were ineligible if classified as Rutherford category 3 or less, had active infection, did not have at least 1 appropriate venous target, and/or had rapidly progressing wounds requiring immediate major amputation. The primary outcome was major amputation-free survival. Secondary outcomes included technical success, limb salvage, survival, primary patency, re-intervention rate, adverse events, partial and complete wound healing. Outcomes were evaluated using Kaplan-Meier method, log-rank and two-stage procedure tests.ResultsTechnical success was achieved in 70 (96%) patients with 1 (2.4%) hospital and 2 (6.3%) office-based laboratory patients lost to follow-up. Major amputation-free survival estimates at 6 months, 1-year and 2-year were 51.4%, 40.4%, 30.2% in the hospital group and 69.4%, 54.0%, and 49.5% in the office-based laboratory group, respectively. Partial wound healing estimates at 6 months, 1-year and 2-year were 27.5%, 71.7%, 81.2% in the hospital group and 62.7% at all time points in the office-based laboratory group. Complete wound healing estimates at 6 months, 1-year and 2-year were 6.7%, 33.3%, 33.3% in the hospital group and 5.3%, 37.7%, and 41.6% in the office-based laboratory group, respectively. There was no significant difference in major amputation-free survival (p=.13), limb salvage (p=.07), survival (p=.69), primary patency (p=.53), partial (p=.08) or complete wound healing (p=.79) between groups. Re-intervention was performed in 8 (20.5%) hospital and 14 (45.2%) office-based laboratory patients.ConclusionPercutaneous deep venous arterialization is a feasible and safe procedure for no-option critical limb ischemia in the hospital and office-based laboratory setting without significant differences in outcomes at up to 2 years.
Purpose: To evaluate the feasibility and safety of percutaneous deep venous arterialization (pDVA) performed in an officebased laboratory (OBL) for patients with no-option critical limb ischemia (CLI). Materials and Methods: A retrospective chart review was performed of all patients who underwent pDVA using commercially available devices from January 2018 to November 2021 in a single OBL. In total, 22 patients (10 males and 12 females; Rutherford 4, 5, and 6: n = 1, 8, and 13, respectively) were identified with a median follow-up of 140 days. Amputation-free survival, wound healing, pDVA patency, and overall survival were evaluated at 30 days, 6 months, and throughout the remaining follow-up period. Results: All patients had undergone failed previous attempts at endovascular arterial reconstruction. At 6 months after procedure, 6.4% of arteriovenous conduits remained patent; 83.3% (10/12) of patients experienced complete or partial wound healing. In addition, 78.6% of patients avoided an above-ankle amputation, and overall survival was 83.6%. Nine patients underwent endovascular reinterventions at 6 months. One mild adverse event and 4 moderate adverse events occurred after procedure, and 1 cardiac death occurred 5 days after procedure. Conclusions: pDVA is safe and feasible in the OBL for patients with no-option CLI. Many patients avoided an above-ankle amputation during the study period despite low overall pDVA patency.
BACKGROUND:Atherectomy is an important option for debulking atherosclerotic plaque from diseased arteries in patients with infrainguinal arterial disease. Laser atherectomy uses a high-powered laser to remove the plaque from the arteries to restore blood flow. AIMS:The Pathfinder multicenter registry was initiated to evaluate the safety and efficacy of the 355 nm laser atherectomy system in a real-world setting for the treatment of de novo, re-stenotic and in-stent restenosis (ISR) lesions in infrainguinal arteries of patients with peripheral artery disease (PAD). METHODS:The study was a prospective, single-arm, multicenter, open-label registry study for patients treated with the 355 nm laser system. Clinical and lesion characteristics, procedural safety and efficacy data, and baseline, 6-, and 12-month outcomes data, including Ankle Brachial Index (ABI), Rutherford class, and Walking Impairment Questionnaires (WIQ), were collected. The primary efficacy endpoint was the achievement of ≤30% final residual stenosis at the index lesion postatherectomy and adjunctive therapy evaluated by an angiographic Core Lab. The primary safety endpoint was the percentage of subjects who did not experience periprocedural major adverse events (PPMAEs) before discharge. RESULTS:One hundred and two subjects with 121 lesions treated with the 355 nm laser device at 10 centers were included in the analysis. Mean age was 68.4 ± 10.21 years, 61.8% of subjects were male, 44.6% had critical limb ischemia (CLI), and 47.3% had tibial lesions. The mean residual stenosis at the end of the procedure was 24.4 ± 15.5 with 69 lesions (69.0%) achieving technical procedural success (<30% stenosis); similar rates were observed for subjects with ISR (25.5 ± 14.9), chronic total occlusion (CTO) (28.1 ± 17.0), and severe calcification (36.5 ± 21.6) lesions. Mean ABI, Rutherford, and WIQ scores were improved at both 6 and 12 months. Ninety-seven of 102 subjects (95.1%) met the primary safety endpoint of not experiencing a PPMAE before discharge. CONCLUSIONS:The initial data from the Pathfinder Registry demonstrates the 355 nm laser system is safe and effective in a real-world setting for performing atherectomy in patients with infrainguinal PAD.
Purpose: Percutaneous deep venous arterialization (DVA) using a stent-graft system is a novel endovascular approach in the treatment of patients with Buerger’s Disease.
Background:Critical limb-threatening ischemia (CLTI) is a severe condition characterized by rest pain and ischemic tissue loss that affects 5% to 10% of people with peripheral artery disease. In the United States, there are few Food and Drug Administration-approved devices for the primary treatment of arteries below-the-knee (BTK). Unfortunately, all suffer from high restenosis rates due to intimal hyperplasia, elastic recoil, and untreated dissection because of a lack of scaffolding. The Esprit BTK system is a resorbable, drug-eluting scaffold device with the potential to address an unmet need in people suffering from CLTI because of infrapopliteal atherosclerosis. The LIFE-BTK (pivotaL Investigation of saFety and Efficacy of drug-eluting resorbable scaffold treatment-Below The Knee) randomized controlled trial (RCT) is a prospectively designed premarket evaluation of the Esprit BTK drug-eluting resorbable scaffold used in the treatment of those patients. Methods:The LIFE-BTK trial enrolled 261 subjects with CLTI for the RCT and a further 7 subjects for a pharmacokinetic substudy. The objective of the RCT was to evaluate the safety and efficacy of the Esprit BTK scaffold compared to percutaneous transluminal angioplasty. The primary efficacy end point was a composite of limb salvage and primary patency at 12 months. The primary safety end point is freedom from major adverse limb events and peri-operative death at 6 months and 30 days, respectively. Clinical follow-up care is planned for 5 years. Conclusions:Novel devices must be tested in RCTs to evaluate their safety and efficacy compared to the standard of care if we are to improve outcomes for this challenging group of patients.
Report the infra-popliteal lesions subgroup analysis of Auryon Laser Atherectomy System in a post market study treating infrainguinal PAD. 12 month follow up was reviewed from 41 patients (47 lesions) treated for infra-popliteal disease in the Pathfinder Registry (70.7% male, age 67.5 ± 9.23, 73.2% DM, 9.8% CKD, 72.5% CLI), Core Lab analysis of angiograms and duplex ultrasound was utilized in all patients. Average lesion length was 13.73 (0.85-40.00 cm), 46.8% were CTOs, and 34.0% were moderate-severely calcified. Stenosis percentage was 85.2 ± 18.35, 65.0 ± 22.95 and 29.4 ± 18.29 at baseline, post laser and post procedure respectively. There were no procedural perforations, emboli, amputations, or deaths. One (2.1%) mild dissection and 1 (2.1%) bailout stenting post balloon occurred. Freedom from MAEs was 97.4% at 30-days (N = 38) with 1 (2.6%) CD-TLR, 94.4% at 6-months (N = 36) with 1 (2.8%) amputation, and 94.3% at 12-months (N = 35), with no additional MAEs. There were 4 (9.8%) all-cause deaths, unrelated to PAD or the procedure. Rutherford, ABI, and WIQ improved at 12 months (N = 23,23,12) comparing to baseline (4.18 ± 0.98 vs. 1.43 ± 1.50; 0.81 ± 0.28 vs. 1.14 ± 0.46; and 26.54 ± 28.46 vs. 36.86 ± 20.82, respectively). Initial post market data on real-world cases with Auryon in a variety of complex infra-popliteal lesions demonstrates excellent safety and outcomes. Low CD-TLR rates with improved clinical presentation were consistent with prior data, and stable out to 12 months.
Iliofemoral venous outflow obstruction may occur secondary to thrombotic, postthrombotic, and nonthrombotic etiologies. Nonthrombotic etiologies include extrinsic vascular/osseous compression or compression due to an adjacent mass (1Harris M. Lim C.S. Chronic venous outflow obstruction: an important cause of chronic venous disease.Cleve Clin J Med. 2021; 88: 680-688Crossref PubMed Google Scholar). In patients with outflow obstruction that does not resolve with angioplasty or thrombectomy alone, venous stent reconstruction can be an effective treatment (2Black S. Janicek A. Knuttinen M.G. Re-intervention for occluded iliac vein stents.Cardiovasc Diagn Ther. 2017; 7: S258-S266Crossref PubMed Scopus (8) Google Scholar). The complications of iliac venous stent placement include deep vein or stent thrombosis, hemorrhage of the retroperitoneum/access site, and, rarely, arterial injury. Cases of arterial compression adjacent to venous stent reconstruction have been reported previously (3Vasudev R. Guragai N. Rampal U. et al.Stenosis of external iliac artery due to compression from previous stent placement in iliac vein: an intravascular ultrasound guided approach.J Am Coll Cardiol. 2019; 73: 2443Crossref Google Scholar,4Filtes J. Chervonski M. Reis S. Ahmad N. Arterial occlusion after ipsilateral venous stent placement for iliac venous obstruction secondary to tumor compression.J Vasc Interv Radiol. 2021; 32: 1501-1503Abstract Full Text Full Text PDF PubMed Google Scholar). Preservation of concurrent arterial/venous wire access can facilitate the management of vascular compromise in such complicated cases. This report describes a case utilizing this technique to resolve external iliac artery compression after iliac venous stent reconstruction in a patient who had undergone extensive pelvic radiation therapy. Approval from the institutional review board was not required for publication. A 55-year-old woman with anorectal squamous cell carcinoma treated with high-dose radiation 2 years prior presented to a clinic with recurrent complaint of right lower-extremity (RLE) swelling and heaviness. She had undergone a recent venous intervention a few months earlier for a similar presentation in the left lower extremity; this previous intervention was complicated by existing radiation-induced pelvic fibrosis such that venous stent reconstruction in a rigid anatomic environment compressed the adjacent artery. Compression by the adjacent venous stent made gaining arterial access across the stenosed segment for arterial stent placement difficult, especially with hindrance due to stiff pelvic anatomy, although these barriers were eventually overcome. Based on the patient’s symptoms of RLE swelling and prior complicated operative history, she was scheduled for subsequent venography with concurrent ipsilateral arteriography in anticipation of similar complications. An initial arteriogram demonstrated patent iliac arteries without evidence of stenosis (Fig a). However, arterial wire access was intentionally maintained throughout the venous intervention. Venography demonstrated diffuse, severe stenosis of the right external iliac vein and proximal common femoral vein (Fig b), which was confirmed using intravascular ultrasound. Percutaneous transluminal angioplasty was employed, with limited success, followed by placement of two 12-mm × 6-cm and one 10-mm × 6-cm overlapping bare-metal stents (Abre; Medtronic, Minneapolis, Minnesota). Repeat venography demonstrated venous patency, with improved vessel caliber and decreased filling of collateral vessels (Fig c). Attention was then redirected to RLE arteries. Repeat arteriography identified an abrupt cutoff of the proximal external iliac artery, with reconstitution of the common femoral artery via collateral vessels (Fig d). Utilizing the maintained arterial wire access, an 8-mm Viabahn x 10-cm (Gore Medical, Flagstaff, Arizona) stent graft was deployed without difficulty within the external iliac artery adjacent to the stent complex in the external iliac vein. Arterial patency was achieved (Fig e), with palpable pulses to the groin and Doppler signals in the right foot. After the procedure, the patient recovered well. The arterial/venous segments remained widely patent on follow-up ultrasound/computerized tomography, without evidence of thrombosis or stenosis over 6 months. The patient did report some symptoms of continued RLE neuropathy, which has remained stable and is thought to be related to concurrent chemotherapy. The treatment of iliac lesions is critical in patients who struggle with lower-extremity venous disease because iliofemoral venous stent placement can reduce the symptoms of venous stasis associated with obstruction. However, the treatment of these lesions can prove challenging in patients with other comorbidities or those who have received prior procedures/therapies in this region. In rare cases, such as that described herein, venous reconstruction may add an increased risk of inducing lower-extremity arterial injury or occlusion during venous stent deployment. Vasudev et al (3Vasudev R. Guragai N. Rampal U. et al.Stenosis of external iliac artery due to compression from previous stent placement in iliac vein: an intravascular ultrasound guided approach.J Am Coll Cardiol. 2019; 73: 2443Crossref Google Scholar) reported a case of arterial stenosis following venous stent placement in a patient being treated for May-Thurner syndrome. Another case reported compression of the right common iliac artery after stent placement in the left common iliac vein secondary to retroperitoneal fibrosis (4Filtes J. Chervonski M. Reis S. Ahmad N. Arterial occlusion after ipsilateral venous stent placement for iliac venous obstruction secondary to tumor compression.J Vasc Interv Radiol. 2021; 32: 1501-1503Abstract Full Text Full Text PDF PubMed Google Scholar). In this report, suspected fibrosis of the pelvic region, caused by prior high-dose radiation therapy for this patient’s prior squamous cell carcinoma, likely limited the physical capacity to house normal-sized iliac vessels. Although not needed here, performing angioplasty in both the adjacent artery and vein can stretch the fibrotic sheath so that arterial and venous stents can properly expand without crushing each other. Furthermore, this case verified the importance of maintaining arterial wire access in patients who are vulnerable to arterial compromise after venous treatment. In this patient, while treating the left lower extremity, the lack of initial arterial wire access complicated the treatment of the compressive arterial occlusion. During the planning/execution of the subsequent right-sided intervention, wire access was intentionally maintained through the arterial limb during venous reconstruction, which ultimately allowed for prompt treatment. In cases in which there is a potential for compromise of adjacent arterial supply, arterial access should be considered, and wire access maintained, prior to venous stent reconstruction.
BACKGROUND:The identification of hemodynamically stable pulmonary embolism (PE) patients who may benefit from advanced treatment beyond anticoagulation is unclear. However, when intervention is deemed necessary by the PE patient's care team, data to select the most advantageous interventional treatment option are lacking. Limiting factors include major bleeding risks with systemic and locally delivered thrombolytics and the overall lack of randomized controlled trial (RCT) data for interventional treatment strategies. Considering the expansion of the pulmonary embolism response team (PERT) model, corresponding rise in interventional treatment, and number of thrombolytic and nonthrombolytic catheter-directed devices coming to market, robust evidence is needed to identify the safest and most effective interventional option for patients. METHODS:The PEERLESS study (ClinicalTrials.gov identifier: NCT05111613) is a currently enrolling multinational RCT comparing large-bore mechanical thrombectomy (MT) with the FlowTriever System (Inari Medical, Irvine, CA) vs catheter-directed thrombolysis (CDT). A total of 550 hemodynamically stable PE patients with right ventricular (RV) dysfunction and additional clinical risk factors will undergo 1:1 randomization. Up to 150 additional patients with absolute thrombolytic contraindications may be enrolled into a nonrandomized MT cohort for separate analysis. The primary end point will be assessed at hospital discharge or 7 days post procedure, whichever is sooner, and is a composite of the following clinical outcomes constructed as a hierarchal win ratio: (1) all-cause mortality, (2) intracranial hemorrhage, (3) major bleeding, (4) clinical deterioration and/or escalation to bailout, and (5) intensive care unit admission and length of stay. The first 4 components of the win ratio will be adjudicated by a Clinical Events Committee, and all components will be assessed individually as secondary end points. Other key secondary end points include all-cause mortality and readmission within 30 days of procedure and device- and drug-related serious adverse events through the 30-day visit. IMPLICATIONS:PEERLESS is the first RCT to compare 2 different interventional treatment strategies for hemodynamically stable PE and results will inform strategy selection after the physician or PERT determines advanced therapy is warranted.
Purpose: To determine the frequency of medial arterial calcification (MAC) fracture following Auryon laser atherectomy using micro-CT and histologic evaluation in an atherosclerotic human cadaveric limb model.Methods: Two below-the-knee calcified arterial segments from human cadaver limbs underwent treatment with the Auryon laser system with or without plain old balloon angioplasty (POBA). Micro-CT and angiography were performed before and after treatment followed by histological evaluation of regions showing calcium disruption.Results: All treatment zones were successfully treated with the Auryon laser (n = 9). Six of 9 treatment zones showed calcium fracture on micro-CT. Each treatment zone was further subdivided using micro-CT analysis (36 evaluated sections) of which 18 sections revealed calcium fracture. Sections with calcium fracture had significantly more confluent and uninterrupted circumferential calcification than sections without calcium fracture (arc of calcification 360.0 [323.7-360.0] vs 312.8 [247.4-314.2] degree, p = 0.007), whereas there were no differences in size of calcium burden (3.4 [2.8-3.9] vs 2.8 [1.3-4.6] mm2, p = 0.46). No arterial dissection or rupture was seen.Conclusions: Auryon laser atherectomy produced fractures of medial arterial calcification in this cadaveric human atherosclerotic peripheral artery model. This effect was observed in arterial segments with a pattern of circumferential uninterrupted calcification (i.e. larger arc of calcification) regardless of calcium burden. Our pilot data suggests Auryon laser may be a promising therapy for calcified lesions.(c) 2023 The Authors. Published by Elsevier Inc.This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
Critical limb-threatening ischemia (CLTI) is a severe manifestation of peripheral arterial disease with a highly increased risk for morbidity and mortality that has limited and suboptimal opportunities for treatment, ultimately resulting in major amputation for patients. Deep venous arterialization (DVA) provides a suitable limb salvage option for "no-option" patients facing amputation by introducing an artificial anastomosis between a site of proximal arterial inflow and retrograde venous outflow to deliver tissue perfusion to lower extremity wounds. Because DVAs are employed as a last-resort effort in CLTI patients, it is important to provide updated information on indications for usage, strategies in creating DVA conduits, and discussion of outcomes and expectations for patients undergoing this procedure. Additionally, variations in method, including use of various techniques and devices, are explored. The authors provide an up-to-date review of the literature and discuss pertinent procedural and technical considerations for utilizing DVAs in CLTI patients.
Subintimal recanalization of chronic superficial femoral artery (SFA) and Popliteal artery (PA) occlusions has a reported failure rate of up to 20% from the traditional antegrade approach. Here we report our experiences performing recanalization of challenging SFA and/or PA occlusions utilizing rendezvous techniques and retrograde popliteal artery access from an anterior fluoroscopically guided approach.
Report the safety and efficacy of the Auryon Laser Atherectomy System in a post market study treating infrainguinal lesions and occlusions.