Everolimus eluting bioresorbable vascular scaffolds for infrapopliteal critical limb ischemia: Moving beyond grasping at metal straws.

Consistent and durable patency and clinical benefit after initially successful infrapopliteal percutaneous balloon transluminal angioplasty (PTA) for critical limb ischemia remains an unmet need. Permanently implanted metallic stents for suboptimal initial infrapopliteal PTA results also have limited patency and clinical results as well as other drawbacks. In 48 critical limb ischemia patients with infrapopliteal lesions < 50 mm length, everolimus eluting bioresorbable vascular scaffolds (EEBVS) achieved 90% primary patency and freedom from clinically driven target lesion revascularization at 2 years follow-up with no late scaffold thrombosis.

Directional atherectomy before paclitaxel coated balloon angioplasty in complex femoropopliteal disease: The VIVA REALITY study.

BACKGROUND: Drug coated balloon (DCB) angioplasty significantly reduces reintervention rates in patients with symptomatic femoropopliteal peripheral artery disease (PAD). However, stand-alone DCB use in long, severely calcified lesions is frequently associated with vessel recoil and/or high-grade dissections necessitating provisional stent implantation. OBJECTIVES: Assess the safety and effectiveness of a vessel preparation strategy with directional atherectomy (DA) prior to DCB angioplasty in patients with symptomatic severely calcified femoropopliteal PAD. METHODS: REALITY (NCT02850107) prospectively enrolled subjects at 13 multinational centers with 8-36 cm femoropopliteal stenoses or occlusions with bilateral vessel wall calcification treated with DA prior to DCB angioplasty. The primary effectiveness endpoint was 12-month primary patency, and the primary safety endpoint was freedom from major adverse events through 30 days. Independent angiographic and duplex core laboratories assessed outcomes and a Clinical Events Committee adjudicated events. RESULTS: A total of 102 subjects were enrolled; one lesion was treated per subject. The mean lesion length was 17.9 ± 8.1 cm, 39.0% were chronic total occlusions (mean lesion length 22.6 ± 8.6 cm); 86.2% of lesions exhibited moderate to severe bilateral calcification. Provisional stents were implanted in 8.8% (9/102) of subjects. Twelve-month primary patency rate was 76.7% (66/86) and freedom from CD-TLR rate was 92.6% (87/94). No device or procedure related deaths and one index-limb major amputation were reported. CONCLUSIONS: Plaque excision with DA in patients with symptomatic severely calcified femoropopliteal arterial disease prior to DCB angioplasty is a safe and effective treatment strategy with a low provisional stent rate.

Safety and efficacy of paclitaxel drug-coated balloon treatment of femoropopliteal claudicants: Data and analytic methods matter.

Claudicants with femoropopliteal disease average 25% higher primary patency and reduced target lesion revascularization long term with crystalline paclitaxel eluting stent and balloon treatment compared to uncoated devices. In animal models, local and downstream tissues have detectable paclitaxel for greater than 180 days. Aggregate data meta-analyses of 28 randomized trials suggested 50-100% higher all-cause mortality with paclitaxel device treatment. In contrast, more complete ascertainment of follow-up and pooled individual patient data analyses do not find significantly increased mortality, a dose-mortality relationship, or an unexpected cause of death pattern with paclitaxel eluting device treatment in femoropopliteal claudicants.

A step forward in predicting anterograde crossing success for infrapopliteal chronic total occlusions.

Forty to fifty percent of critical limb ischemia patients have infrainguinal chronic total occlusions, frequently below-the-knee. With probabilities ranging from 21 to 90%, the Infrapop-CTO Score presented here in CCI predicts the likelihood of anterograde crossing of infrapopliteal chronic total occlusions (CTO). Based on cap morphology, occlusion length, calcification, and restenosis status, the score is easily assessed in the lab. An unfavorable Infrapop-CTO Score of 5 or 6, particularly coupled with convex proximal and distal caps (chronic total occlusion plaque [CTOP] Type IV), portends very low (21%) probability of successful anterograde crossing. An initial retrograde crossing strategy should be considered in these patients when technically feasible, followed by combined anterograde-retrograde intervention.

Maximizing Lumen Gain With Directional Atherectomy.

PURPOSE: To describe the use of a low-pressure balloon inflation (LPBI) technique to delineate intraluminal plaque and guide directional atherectomy in order to maximize lumen gain and achieve procedure success. TECHNIQUE: The technique is illustrated in a 77-year-old man with claudication who underwent superficial femoral artery revascularization using a HawkOne directional atherectomy catheter. A standard angioplasty balloon was inflated to 1 to 2 atm during live fluoroscopy to create a 3-dimensional "lumenogram" of the target lesion. Directional atherectomy was performed only where plaque impinged on the balloon at a specific fluoroscopic orientation. The results of the LPBI technique were corroborated with multimodality diagnostic imaging, including digital subtraction angiography, intravascular ultrasound, and intra-arterial pressure measurements. CONCLUSION: With the LPBI technique, directional atherectomy can routinely achieve <10% residual stenosis, as illustrated in this case, thereby broadly supporting a no-stent approach to lower extremity endovascular revascularization.

Intraprocedural application of a peripheral blood flow monitoring system during endovascular treatment for femoropopliteal disease.

Sensors that implement laser speckle image streaming provide real-time, noninvasive assessment of peripheral blood flow during endovascular revascularization. This single-center feasibility study evaluated a laser speckle-based peripheral blood flow monitoring system in 24 patients with peripheral arterial disease. System-quantified blood flow values showed improvement at the conclusion of the procedure in 20 of 24 patients (83.3%). Of the four patients without improved flow values, waveform morphology improved in three. Waveforms graded as moderate to severe peripheral arterial disease decreased from 71% before the procedure to 25% after the procedure, with improvement in 19 of 24 patients. In this limited population, laser speckle imaging could offer a highly sensitive method of detecting intraprocedural pedal blood flow changes.

Using Arterial Recoil for Large Bore Access Closure After Impella Assist Device Removal.

The use of Impella assist device for high-risk percutaneous coronary interventions and cardiogenic shock has increased in the last decade and requires a large bore arterial access (LBA). However, LBA closure following Impella removal is associated with significant complications. Herein, we describe the safety and efficacy of a novel method of LBA closure using arterial recoil following Impella removal. We performed a retrospective review of electronic medical records of patients who underwent LBA closure using this method from July 1, 2018 to June 30, 2022. The procedure involves controlled downsizing of the arterial sheath from 12 French (Fr) to 6 Fr catheters with intermittent compression to allow patent hemostasis facilitated by arterial recoil. Baseline characteristics and outcomes including closure success, immediate/delayed bleeding, and access site complications were included. Of 103 patients with Impella placement, 20 (19%) underwent LBA closure with this method. Patients were predominantly male (80%) and White (55%) with a mean age of 65 ± 16 years. After downsizing of the femoral sheath to 6 Fr, 14 patients underwent manual compression, 3 patients had a 6 Fr catheter left in place to maintain access, and 3 patients underwent placement of a Perclose or Vascade device. Successful LBA closure was performed in all patients with no immediate or delayed bleeding complications. Five patients (25%) died inpatient; the deaths were unrelated to complications of Impella removal. In conclusion, LBA closure post-Impella removal with this novel method was safe and effective. Further prospective studies are needed to ascertain its comparative efficacy.

Acute Left Ventricular Assist Device Failure From Outflow Graft Dissection Flap Successfully Treated With Stent Placement.

Outflow graft obstruction (OGO) is a potentially fatal complication of left ventricular assist device (LVAD) implantation. Common causes include graft kinking, luminal stenosis, and graft thrombosis. We describe a case of a 51-year-old female who presented with acute LVAD failure and cardiogenic shock. Initial imaging revealed OGO without luminal stenosis following which she was she was empirically treated for graft thrombosis with anticoagulation and catheter-based thrombolytic therapy with no success. Further imaging in the catheterization laboratory revealed a potential neointimal flap dissection acting as a one-way valve. A stent was successfully placed across the outflow graft with immediate resolution of cardiogenic shock. The case emphasizes the importance of including neointimal flap as a differential for OGO in acute LVAD failure, especially in cases where thrombolytic therapy fails to correct hemodynamic compromise.

Distal Trans-radial Access Compared to Conventional Trans-radial Access in Coronary Interventions: A Meta-analysis.

BACKGROUND: Distal trans-radial access (dTRA) is a novel technique of arterial cannulation in coronary interventions. The comparative efficacy of dTRA and conventional trans-radial access (TRA) in attenuating peri-procedural complications is unknown. METHODS: Embase and PubMed/MEDLINE were searched from their inception until June 25, 2022, for randomized clinical trials. Outcomes included were radial artery occlusion (RAO), radial artery spasm, hemostasis time, access time, unsuccessful cannulation, crossover rate, and early discharge after trans-radial stenting of coronary arteries (EASY) type I-III hematomas. Statistical analysis was conducted using the random effects model to derive risk ratios (RRs) and mean differences (MDs) with their corresponding 95% confidence intervals (CIs). RESULTS: A total of 6 randomized clinical trials comprising 3240 patients were included. Subjects were predominantly male (73%) and had a mean age of 66 years. The dTRA group had a lower risk of RAO [RR 0.43 (95% CI, 0.26-0.69); P = 0.0005; I 2 = 0%] and had a shorter hemostasis time [MD -22.85 min (95% CI, -39.06 to -6.65); P = 0.006; I 2 = 99%]. The dTRA group had a higher crossover rate [RR 3.04 (95% CI, 1.88-4.91); P = 0.00001; I 2 = 56%] and a longer access time [MD 0.68 min (95% CI, 0.17-1.18); P = 0.009; I 2 = 99%]. The TRA group had a lower rate of unsuccessful cannulation [RR 0.81 (95% CI, 0.70-0.95); P = 0.01; I 2 = 92%]. There was no significant difference between the groups for radial artery spasm and EASY type I-III hematomas. CONCLUSION: dTRA is a safe alternative to conventional TRA for coronary interventions with a lower risk of RAO. Future trials are required to further compare both approaches.

Deadly Pulmonary Hypertension Cured With a Stent.

A 77-year-old woman with critical limb ischemia, venous insufficiency, and progressive pulmonary hypertension presented for evaluation. Lower extremity angiography showed a common iliac arteriovenous fistula. Closure was achieved with a covered stent placed in the artery. (Level of Difficulty: Intermediate.).