Optimized drug-coated balloon angioplasty of the superficial femoral and proximal popliteal arteries using the Tack Endovascular System: Tack Optimized Balloon Angioplasty (TOBA) III 24-month results in standard and long lesions.

OBJECTIVE: The Tack Endovascular System is a minimal-metal dissection repair device that is purpose-built to treat post-percutaneous angioplasty (PTA) arterial dissections in patients with peripheral arterial disease (PAD). The Tack Optimized Balloon Angioplasty (TOBA) III trial evaluated the safety and effectiveness of the Tack Endovascular System in patients with superficial femoral artery (SFA) and/or proximal popliteal artery (PPA) dissection after PTA with a drug-coated balloon (DCB). The objective of this study is to report the results in the standard- (SL) and long-lesion (LL) cohorts through 24 months. DESIGN: The TOBA III study was a prospective, multicenter, single-arm study including patients suffering from Rutherford category 2-4 PAD. Outcomes were assessed according to pre-specified lesion length in SL ( ≥ 20 mm and ≤150 mm) and LL ( > 150 mm and ≤250 mm) cohorts. Follow-up was through 24 months. RESULTS: TOBA III enrolled 201 patients, 169 patients in the SL cohort and 32 in the LL cohort. At 24 months, the Kaplan-Meier estimates of freedom from major adverse events were 91.7% and 82.6% for the SL cohort and LL cohort, respectively. Kaplan-Meier estimates of freedom from clinically driven-target lesion revascularization (CD-TLR) were 92.3% in the SL cohort and 82.6% in the LL cohort. At 24 months, 78.8% of SL patients and 69.2% of LL patients experienced an improvement of >2 Rutherford categories (both cohorts p < 0.001). The baseline ankle-brachial index improved from 0.68 ± 0.18 to 0.93 ± 0.16 in the SL (p < 0.001) and from 0.62 ± 0.23 to 0.87 ± 0.15 in the LL cohort (p < 0.001) at 24 months. CONCLUSION: The 24-month results of the TOBA III trial support the safety and effectiveness of the Tack Endovascular System in patients who required post-PTA dissection repair in the SFA and PPA following DCB angioplasty for claudication and rest pain. In both the SL and LL cohorts, Tack placement was associated with sustained freedom from CD-TLR through 24 months as well as sustained improvements in Rutherford categories, ankle-brachial index, and quality of life.

Twenty-Four Month Results of Tack-Optimized Balloon Angioplasty Using the Tack Endovascular System in Below-the-Knee Arteries.

PURPOSE: To report 24 month safety and efficacy of the Tack Endovascular System for treatment of post-percutaneous transluminal angioplasty (PTA) infrapopliteal dissections in patients with critical limb-threatening ischemia (CLTI). MATERIALS AND METHODS: The Tack-Optimized Balloon Angioplasty (TOBA) II below-the-knee (BTK) study was a prospective, multicenter, single-arm evaluation of the Tack Endovascular system for post-PTA infrapopliteal dissection repair. Patients with Rutherford Clinical Category (RC) 3 to 5 and a post-PTA dissection(s) of the BTK arteries were enrolled. The 30 day primary safety endpoint was a composite of major adverse limb events (MALE) and all-cause perioperative death (POD). The primary effectiveness endpoint was a composite of MALE at 6 months and 30 day POD. Outcomes were assessed as observational endpoints at 24 months. RESULTS: Tack-Optimized Balloon Angioplasty II BTK enrolled 233 patients; all patients had a post-PTA dissection(s) and received ≥1 Tack implant (range, 1-16). Mean age was 74.4±10.0 years and 67.4% were men. Most patients had CLTI (RC 3: 16.3%; RC 4/5: 83.7%). Mean target lesion length was 80±49 mm. Moderate to severe calcium was present in 89 (35.8%) lesions and total occlusions were present in 118 (47.6%) lesions. Kaplan-Meier freedom from MALE at 24 months + POD at 30 days was 92.2% and 24 month freedom from clinically-driven target lesions revascularization was 73.6%. Kaplan-Meier target limb salvage was 95.7% and amputation-free survival was 75.4%. Improvements in functional status and quality of life were observed through 24 months. CONCLUSION: The TOBA II BTK study demonstrated sustained safety and efficacy through 24 months in patients treated for post-PTA dissection(s) of BTK lesions. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT02942966.

Carotid artery revascularization using second generation stents versus surgery: a meta-analysis of clinical outcomes.

INTRODUCTION: Meta-analyses and emerging randomized data indicate that second-generation ('mesh') carotid stents (SGS) may improve outcomes versus conventional (single-layer) stents but clinically-relevant differences in individual SGS-type performance have been identified. No comparisons exist for SGS versus carotid endarterectomy (CEA). EVIDENCE ACQUISITION: Thirty-day death (D), stroke (S), myocardial infarction (M), and 12-month ipsilateral stroke and restenosis in SGS studies were meta-analyzed (random effect model) against CEA outcomes. Eligible studies were identified through PubMed/EMBASE/COCHRANE. Forest plots were formed for absolute adverse evet risk in individual studies and for relative outcomes with each SGS deign versus contemporary CEA outcomes as reference. Meta-regression was performed to identify potential modifiers of treatment modality effect. EVIDENCE SYNTHESIS: Data were extracted from 103,642 patients in 25 studies (14 SGS-treated, 41% symptomatic; nine randomized controlled trial (RCT)-CEA-treated, 37% symptomatic; and two Vascular Quality Initiative (VQI)-CEA-treated, 23% symptomatic). Casper/Roadsaver and CGuard significantly reduced DSM versus RCT-CEA (-2.70% and -2.95%, P<0.001 for both) and versus VQI-CEA (-1.11% and -1.36%, P<0.001 for both). Gore stent 30-day DSM was similar to RCT-CEA (P=0.581) but increased against VQI-CEA (+2.38%, P=0.033). At 12 months, Casper/Roadsaver ipsilateral stroke rate was lower than RCT-CEA (-0.75%, P=0.026) and similar to VQI-CEA (P=0.584). Restenosis with Casper/Roadsaver was +4.18% vs. RCT-CEA and +4.83% vs. VQI-CEA (P=0.005, P<0.001). CGuard 12-month ipsilateral stroke rate was similar to VQI-CEA (P=0.850) and reduced versus RCT-CEA (-0.63%, P=0.030); restenosis was reduced respectively by -0.26% and -0.63% (P=0.033, P<0.001). Twelve-month Gore stent outcomes were overall inferior to surgery. CONCLUSIONS: Meta-analytic integration of available clinical data indicates: 1) reduction in stroke but increased restenosis rate with Casper/Roadsaver, and 2) reduction in both stroke and restenosis with CGuard MicroNET-covered stent against contemporary CEA outcomes at 30 days and 12 months used as a reference. This may inform clinical practice in anticipation of large-scale randomized trials powered for low clinical event rates (PROSPERO-CRD42022339789).

Clinical Outcomes of Second- versus First-Generation Carotid Stents: A Systematic Review and Meta-Analysis.

Background: Single-cohort studies suggest that second-generation stents (SGS; "mesh stents") may improve carotid artery stenting (CAS) outcomes by limiting peri- and postprocedural cerebral embolism. SGS differ in the stent frame construction, mesh material, and design, as well as in mesh-to-frame position (inside/outside). Objectives: To compare clinical outcomes of SGS in relation to first-generation stents (FGSs; single-layer) in CAS. Methods: We performed a systematic review and meta-analysis of clinical studies with FGSs and SGS (PRISMA methodology, 3302 records). Endpoints were 30-day death, stroke, myocardial infarction (DSM), and 12-month ipsilateral stroke (IS) and restenosis (ISR). A random-effect model was applied. Results: Data of 68,422 patients from 112 eligible studies (68.2% men, 44.9% symptomatic) were meta-analyzed. Thirty-day DSM was 1.30% vs. 4.11% (p < 0.01, data for SGS vs. FGS). Among SGS, both Casper/Roadsaver and CGuard reduced 30-day DSM (by 2.78 and 3.03 absolute percent, p = 0.02 and p < 0.001), whereas the Gore stent was neutral. SGSs significantly improved outcomes compared with closed-cell FGS (30-day stroke 0.6% vs. 2.32%, p = 0.014; DSM 1.3% vs. 3.15%, p < 0.01). At 12 months, in relation to FGS, Casper/Roadsaver reduced IS (−3.25%, p < 0.05) but increased ISR (+3.19%, p = 0.04), CGuard showed a reduction in both IS and ISR (−3.13%, −3.63%; p = 0.01, p < 0.01), whereas the Gore stent was neutral. Conclusions: Pooled SGS use was associated with improved short- and long-term clinical results of CAS. Individual SGS types, however, differed significantly in their outcomes, indicating a lack of a "mesh stent" class effect. Findings from this meta-analysis may provide clinically relevant information in anticipation of large-scale randomized trials.

Prospective Study of Serration Angioplasty in the Infrapopliteal Arteries Using the Serranator Device: PRELUDE BTK Study.

PURPOSE: The purpose was to evaluate the safety and efficacy of the Serranator percutaneous transluminal angioplasty serration balloon catheter in patients with infrapopliteal peripheral artery disease. MATERIALS AND METHODS: A prospective, multicenter, single-arm feasibility study in 46 patients with claudication or chronic limb-threatening ischemia, Rutherford Clinical Category (RCC) 3 to 5, that required treatment of the infrapopliteal arteries above the tibiotalar joint. The primary efficacy outcome was device success-successful insertion, balloon inflation and deflation, and removal of the device(s) with a final diameter stenosis of <50%. The primary safety endpoint was a composite of major adverse limb events (MALE) and perioperative death (POD) through 30 day postprocedure. Other outcomes were change in RCC and ankle-brachial index, wound healing, and clinically-driven target lesion revascularization (CD-TLR). A subset of 9 patients were further evaluated by optical coherence tomography (OCT) or intravascular ultrasound (IVUS) for the presence of serrations in treated lesions. Patient follow-up occurred at 30 days and 6 months. RESULTS: Forty-six patients received treatment with the Serranator device and 55 lesions were treated. Fifty-three lesions were deemed analyzable by the core lab with data and reported hereafter. Device success was 91.7% and freedom from MALE + POD through 30 days was 95.7%. Pretreatment stenosis of 82% was reduced to 21.8% and only 1 lesion (1.9%) required a bailout stent for a grade D dissection. The average maximum balloon inflation pressure was 6 atmospheres. Serrations were present in all treated lesions (n=10) in 9 patients imaged with OCT/IVUS as reviewed by the core laboratory. The RCC score improved by 1 or more level in 70% of patients at 6 months with 42% having a score of 0. The 6 month freedom from CD-TLR was 97.7%. CONCLUSION: Serranator treatment of infrapopliteal lesions showed excellent lumen gain with minimal evidence of arterial injury and low 6 month CD-TLR. Imaging by IVUS and OCT showed serrations without significant dissection, supporting the device's proposed mechanism of action.

Optimized drug-coated balloon angioplasty of the superficial femoral and proximal popliteal arteries using the Tack Endovascular System: TOBA III 12-month results.

OBJECTIVE: The Tack Endovascular System (Intact Vascular, Wayne, Pa) combines low-metallic content with focal delivery to seal areas of dissection associated with balloon angioplasty. The device system is designed to treat vascular dissections in the superficial femoral and proximal popliteal arteries. Tack implants exert low radial force and are associated with minimal metal burden, which reduces the mechanical stress on the arterial wall in treating dissections after balloon angioplasty. This study investigated the safety and effectiveness of the Tack Endovascular System in patients with dissections after drug-coated balloon (DCB) angioplasty. METHODS: The Tack Optimized Balloon Angioplasty III (TOBA III) study is a prospective, multicenter, single-arm study in which patients who underwent percutaneous transluminal angioplasty with the Medtronic IN.PACT Admiral DCB (Medtronic, Dublin, Ireland) and experienced dissection after angioplasty were treated with Tack implants. The primary end points were freedom from major adverse events at 30 days and primary patency at 12 months. RESULTS: A total of 201 patients were enrolled in the trial, 169 with standard-length lesions (≥20 mm and ≤150 mm) and 32 with long-length lesions (>150 mm and ≤250 mm). Safety and effectiveness results were favorable compared with historical benchmarks at 12 months in the standard-lesion cohort. Notably, patients in the standard-lesion cohort experienced 95.0% primary patency, 97.5% freedom from clinically driven target lesion revascularization, 100% freedom from amputation, and 100% survival at 12 months (P < .0001). Primary patency in long-lesion patients was 89.3%, freedom from clinically driven target lesion revascularization was 96.8%, and freedom from amputation was 100% at 12 months. Device success was achieved in 95.8% (182/190) and 97.7% (43/44) of devices deployed into standard-lesion and long-lesion patients, respectively. Procedural success was 99.4% (168/169) and 100% (44/44) in the standard-lesion and long-lesion cohorts, respectively, with only one bailout stent placed in the entire population. CONCLUSIONS: The Tack Endovascular System is a safe and effective treatment option for patients with dissections after angioplasty in the superficial femoral and proximal popliteal arteries, with high patency, low rates of secondary intervention, and low incidence of bailout stenting when it is used in combination with DCB.

Twelve-Month Results of Tack-Optimized Balloon Angioplasty Using the Tack Endovascular System in Below-the-Knee Arteries (TOBA II BTK).

Purpose: To report the 12-month safety and efficacy outcomes of the investigational device exemption trial evaluating an implantable below-the-knee (BTK) dissection repair device. Materials and Methods: The prospective, multicenter, single-arm Tack-Optimized Balloon Angioplasty (TOBA) II BTK study (ClinicalTrials.gov identifier NCT02942966) evaluated the Tack Endovascular System in the BTK arteries vs objective performance goals derived from a systematic review of BTK angioplasty literature. Patients presenting with Rutherford category 3-5 ischemia were eligible and were enrolled during the procedure if angioplasty resulted in dissection(s) of the BTK arteries. Between February 2017 and December 2018, the study enrolled 233 patients (mean age 74.4±10.0 years; 157 men). Most lesions (93.8%) were de novo; almost half (118/248, 47.6%) were total occlusions. Mean target lesion length was 80±49 mm. Moderate to severe calcium was present in 89 (35.8%) lesions. The 30-day primary safety endpoint was a composite of major adverse limb events (MALE) and all-cause perioperative death (POD). The primary efficacy endpoint was a composite of MALE at 6 months and 30-day POD. These safety and efficacy endpoints were assessed at 12 months as observational endpoints along with amputation-free survival (AFS), freedom from clinically-driven target lesion revascularization (CD-TLR), vessel patency, and changes from baseline in clinical and quality of life measures. Results: All patients had post-PTA dissection and received at least 1 Tack implant (range 1 to 16). The angiographic core laboratory noted successful resolution of 100% of the 341 treated dissections. At 12 months, 93.4% (170/182) of patients remained free of the composite endpoint of MALE + POD. Tacked segment patency was 81.3% and limb salvage was 96.8% at 12 months; freedom from CD-TLR and AFS were 83.1% and 89.3%, respectively. Sustained Rutherford category improvement was reported in 82.4% of evaluated patients, with 62.4% improving ≥3 categories (p<0.001). Ninety of 124 index wounds (72.5%) healed or improved. Conclusion: The Tack Endovascular System is safe and effective in the treatment of post-angioplasty BTK dissections. Twelve-month outcome data from the TOBA II BTK study demonstrate high rates of patency, limb salvage, and wound healing.

Initial Clinical Results and In Vitro Testing of the New CGuard MicroNet-Covered "One-Size-Fits-All" Carotid Stent.

Purpose: To evaluate a MicroNet-covered stent designed for the carotid artery with the new ability to adjust to different vessel diameters. Materials and Methods: Thirty consecutive patients (mean age 72.1±7.7 years; 26 men) with symptomatic stenosis (86.3%±6.4%) of the internal carotid artery were treated with the new self-adjusting nitinol stent, which has a self-expanding, open-cell design covered by an outer conformable layer (MicroNet). The only stent used was the "One-Size-Fits-All" CGuard stent with lengths of 30 or 40 mm. In bench testing, the chronic outward force of the One-Size-Fits-All stent was determined with a segmented head radial force test device. The stent was deployed directly into the test device at a diameter of 5.0 mm, and the chronic outward force was measured up to 10.0 mm, the maximum expansion of the stent. Results: The stent was successfully implanted in all 30 patients without periprocedural complications, including no neurological events within 30 days. The chronic outward force normalized by stent length demonstrated a near-equivalent radial force outcome: The stent displayed only a minor difference between the minimal radial force at 9.0 mm (0.195 N/mm) and the maximal radial force at 5.5 mm (0.330 N/mm). Conclusion: The new self-adjusting, MicroNet-covered stent has high conformability combined with an almost equivalent radial force at expansion diameters ranging from 5.5 to 9.0 mm. The first clinical results demonstrate that the new One-Size-Fits-All stent can be safely implanted in internal carotid arteries with reference diameters within this range.

Treatment of infrapopliteal post-PTA dissection with tack implants: 12-month results from the TOBA-BTK study.

OBJECTIVES: The Tack implant is designed for focal, minimal metal management of dissections. This study evaluated Tacks for treating postpercutaneous transluminal angioplasty (PTA) dissection in patients with below-the-knee (BTK) arterial occlusive disease. BACKGROUND: PTA is the most commonly used endovascular treatment for patients with occlusive disease of the BTK vessels. Post-PTA dissection is a significant clinical problem that results in poor outcomes, but currently there are limited treatment options for managing dissections. METHODS: This prospective, single-arm study evaluated patients with CLI and BTK lesions; 11.4% were Rutherford category (RC) 4 and 88.6% were RC 5. BTK occlusive disease was treated with standard PTA and post-PTA dissections were treated with Tack placement. The primary safety endpoint was a composite of major adverse limb events (MALE) and perioperative death (POD) at 30 days. Other endpoints included: device success; procedure success (vessel patency in the absence of MALE); freedom from clinically driven target lesion revascularization (CD-TLR); primary patency; and changes in RC. Data through 12 months are presented. RESULTS: Thirty-two of 35 (91.4%) patients had post-PTA dissection and successful deployment of Tacks. Procedural success was achieved in 34/35 (97.1%) patients with no MALEs at 30 days. The 12-month patency rate was 78.4% by vessel, 77.4% by patient, and freedom from CD-TLR was 93.5%. Significant (P < .0001) improvement from baseline was observed in RC (75% of patients improved 4 or 5 steps). CONCLUSION: Tack implant treatment of post-PTA dissection was safe and effective for treatment of BTK dissections and resulted in reasonable 12-month patency and low rates of CD-TLR.

Interventional Angiography: Radiation Protection for the Examiner by using Lead-free Gloves.

INTRODUCTION: The radiation exposure to unprotected parts of the body requires special attention for the interventional radiologist. During angiographic procedures, hands are exposed to the direct X-ray beam and scattered radiation. AIM: The aim of the study was to evaluate the radiation exposure of examiners hand with the use of lead-free X-ray protective gloves in clinical practice in terms of shielding and sense of touch. The aim of the study was to evaluate the radiation exposure of examiners hand with the use of lead-free X-ray protective gloves in clinical practice in terms of shielding and sense of touch. MATERIALS AND METHODS: Phantom measurements were conducted in the direct X-ray beam and the area of scattered radiation with and without shielding. Examiner measurements were determined in interventional angiographies in clinical routine of the lower limb in antegrade puncture technique through the femoral artery. In 24 out of 50 interventions, an elastic natural rubber latex glove with lead-free metal shielding against radiation was used. All measurements were performed with a direct dosimeter. After the intervention, an opinion of the examiner was requested for evaluation of the sense of touch. RESULTS: Phantom measurements; when using the protective glove in the direct X-ray beam, a significant increase of the Dose Area Product (DAP) (1084.2-1603.8 mGy*cm2; 67.6%; p<0.001) as well of the examiner's hand dose (143-221.8 µSv; 64.5%; p<0.001) was observed. A significant reduction of the examiner's hand dose was verifiable for scattered radiation (1.76-0.75 µSv; 42.6%; p<0.001). Examiner measurements; if protective gloves were used, a significant increase of the DAP (6183.2-10462.9 mGy*cm2; 59.1%; p<0.05) and decrease of the average dose rate (0.76-0.43 mSv/h; 56.6%) for the entire procedure was determined. The tactile sensitivity was assessed as not restricted (18/24). CONCLUSION: The new generation of protective gloves is characterized by a shielding effect against X-ray scattered radiation, without restricting the sense of touch. A significant reduction in radiation doses to the examiner can be accomplished with these gloves in the area of scattered radiation only. If the gloves were used in the direct X-ray beam, especially while the artery puncture was performed, a significant increase of the dose values was observed.

Haemostasis with the FISH Vascular Closure Device after 6 French Transfemoral Accesses in Interventional Radiology: Clinical Results.

INTRODUCTION: Endovascular procedures have increased for different indications over the recent years. To achieve a safe haemostasis after arterial puncture and for more comfort for the patients different vascular closure devices have been developed. AIM: To evaluate the effectiveness and safety of a percutaneous closure system based on a matrix patch for achieving haemostasis. MATERIALS AND METHODS: In this study from 2014 to 2015 a percutaneous vascular closure system Femoral Introducer Sheath and Haemostasis (FISH) was used in 54 patients (mean age 69.0±10.7 years), in an antegrade and retrograde technique within the context of an angiographic intervention. The system was used in conjunction with transfemoral approaches with a sheath size of 6F. Postinterventionally (on the following day and after 6 weeks), follow-up was conducted clinically and using colour coded ultrasound. RESULTS: Immediate haemostasis was achieved in 50/54 patients (92.6 %). In 4 cases, an immediate haemostasis was not achieved. In these cases, manual compression was successful. There was one major complication, a retroperitoneal bleeding requiring transfusion. Minor complications were not observed. CONCLUSION: Safe and effective haemostasis is possible with the percutaneous FISH closure system at puncture sizes of 6 F. An immediate re-puncture after using FISH is possible.

Efficiency test of current carotid embolic protection devices.

Embolic protection devices were developed to reduce the risk of stroke during carotid artery stenting. The aim of this study was to test the capture efficiency of five embolic protection devices under reproducible in vitro conditions. The setup consisted of silicone tubes representing the vessel modeling round and oval cross sections. Spherical polystyrene particles (150 µm, COOH-coating) were used to simulate the plaque. The particles were inserted in a clean water circuit and either captured by the device or collected in a glass filter. The missed particles were counted by laser obscuration as a measure of device leakage. The systems Angioguard RX, RX Accunet, FiberNet, FilterWire EZ and EmboshieldNAV were analyzed. At the round cross section, FilterWire EZ demonstrated the highest capture efficiency (0% of missed particles) and RX Accunet the lowest, at 34%. The amount of leaked particles increased to 22% for FilterWire EZ and 89% for Angioguard RX during the test with the oval cross profile.

Clinical Results and Mechanical Properties of the Carotid CGUARD Double-Layered Embolic Prevention Stent.

PURPOSE: To report early clinical outcomes with a novel double-layer stent for the internal carotid artery (ICA) and the in vitro investigation of the stent's mechanical properties. METHODS: A prospective single-center study enrolled 30 consecutive patients (mean age 73.1±6.3 years; 21 men) with symptomatic (n=25) or high-grade (n=5) ICA stenosis treated with the new double-layer carotid CGUARD Embolic Prevention System (EPS) stent, which has an inner open-cell nitinol design with an outer closed-cell polyethylene terephthalate layer. The average stenosis of the treated arteries was 84.1%±7.9% with a mean lesion length of 16.6±2.1 mm. In the laboratory, 8×40-mm stents where tested in vitro with respect to their radial force during expansion, the bending stiffness of the stent system and the expanded stent, as well as the collapse pressure in a thin and flexible sheath. The wall adaptation was assessed using fluoroscopy after stent release in step and curved vessel models. RESULTS: The stent was successfully implanted in all patients. No peri- or postprocedural complications occurred; no minor or major stroke was observed in the 6-month follow-up. The bending stiffness of the expanded stent was 63.1 N·mm2 and (not unexpectedly) was clearly lower than that of the stent system (601.5 N·mm2). The normalized radial force during expansion of the stent to 7.0 mm, consistent with in vivo sizing, was relatively high (0.056 N/mm), which correlates well with the collapse pressure of 0.17 bars. Vessel wall adaptation was harmonic and caused no straightening of the vessel after clinical application. CONCLUSION: Because of its structure, the novel CGUARD EPS stent is characterized by a high flexibility combined with a high radial force and very good plaque coverage. These first clinical results demonstrate a very safe implantation behavior without any stroke up to 6 months after the procedure.

Results from the Tack Optimized Balloon Angioplasty (TOBA) study demonstrate the benefits of minimal metal implants for dissection repair after angioplasty.

OBJECTIVE: The mechanism of angioplasty is disruption of atherosclerotic plaque, which often results in dissections. Dissection after percutaneous transluminal angioplasty (PTA) remains a significant clinical problem and untreated may cause acute occlusion or later restenosis. Stents are used to manage dissections, which is often followed by in-stent restenosis and occasionally stent fracture. Tack (Intact Vascular, Wayne, Pa) implants have minimal metal and low radial force and are specifically designed for dissection repair. This study evaluated Tack implants for treatment of dissections resulting from standard balloon PTA for femoral-popliteal arterial disease. Twelve-month outcomes after Tack treatment of post-PTA dissections are described. METHODS: This prospective, single-arm study evaluated patients with ischemia (Rutherford clinical category 2-4) caused by lesions of the superficial femoral and popliteal arteries. Patients were treated with standard balloon angioplasty, and post-PTA dissections were treated with Tacks. The primary end points were core laboratory-adjudicated device technical success, defined as the ability of the Tack implants to resolve post-PTA dissection, and device safety, defined as the absence of new-onset major adverse events. Patients were followed up to 12 months after implantation. RESULTS: Tacks were used in 130 patients with post-PTA dissections (74.0% ≥ grade C). Technical success was achieved in 128 (98.5%) patients with no major adverse events at 30 days. The 12-month patency was 76.4%, and freedom from target lesion revascularization was 89.5%. Significant improvement from baseline was observed in Rutherford clinical category (82.8% with grade ≤1) and ankle-brachial index (0.68 ± 0.18 to 0.94 ± 0.15; P < .0001). CONCLUSIONS: Tack implant treatment of post-PTA dissection was safe, produced reasonable patency, and resulted in low rates of target lesion revascularization. Tack treatment represents a new, minimal metal paradigm for dissection repair that can safely improve the clinical results associated with PTA.

Preliminary Clinical Results and Mechanical Behavior of a New Double-Layer Carotid Stent.

PURPOSE: To evaluate the in vitro mechanical and clinical implant behavior of a next-generation double-layer stent designed for the carotid artery. METHODS: The new double-layer CASPER-RX stent was implanted in 12 patients (median age 69 years; 8 men) with high-grade symptomatic internal carotid artery stenoses (mean 82%). In the in vitro experiments, the CASPER-RX stent (8-×40-mm model) was investigated with respect to its radial force on expansion and the bending stiffness of the stent system and of the stent in its expanded state, as well as the collapse pressure in a thin, flexible sleeve. The wall adaptation of the expanded stents was assessed by fluoroscopy after release in a step and curve model. RESULTS: Technical success was achieved in all patients without complications; there was no peri- or postinterventional stroke and no stroke or restenosis after 6 months. In the experimental studies, the bending stiffness of the stent on the delivery system (154.9 N mm(2)) was significantly lower than when expanded in a 7-mm flexible tube (467.4 N mm(2)). The radial force on expansion of the stent to 7 mm was low (0.011 N/mm). The collapse pressure was relatively high (0.56 bar) as a result of the stent's particular stent structure. The stent exhibited significant foreshortening of 27.6%. The conformability to the wall in the step model was relatively smooth; in the curve model, straightening occurred with consecutive slight stenosis. CONCLUSION: The first clinical results showed a safe implantation behavior without the occurrence of any ischemia. The structure of the new CASPER-RX stent creates an acceptable flexibility, low radial force, and high collapse pressure. The large foreshortening during implantation should be considered as well as the higher bending stiffness, especially when used in elongated carotid arteries.

Aortoenteric fistula as a complication of open reconstruction and endovascular repair of abdominal aorta.

The paper intends to present a review of imaging characteristics of secondary aortoenteric fistula (AEF). Mechanical injury, infection, and adherence of a bowel segment to the aorta or aortic graft are major etiologic factors of AEF after open aortic repair. The pathogenesis of AEF formation after endovascular abdominal aortic repair is related to mechanical failure of the stent-graft, to stent graft infection, and to persistent pressurization of the aneurysmal sac. The major clinical manifestations of AEF comprise haematemesis, melaena, abdominal pain, sepsis, and fever. CT is the initial diagnostic modality of choice in a stable patient. However, the majority of reported CT appearances are not specific. In case of equivocal CT scans and clinical suspicion of AEF, scintigraphy, (67)Ga citrate scans or (18)F-FDG PET/CT is useful. Diagnostic accuracy of endoscopy in evaluation of AEF is low; nevertheless it allows to evaluate other than AEF etiologies of gastrointestinal bleeding. Without adequate therapy, AEF is lethal. Conventional surgical treatment is associated with high morbidity and mortality. The endovascular repair may be an option in hemodynamically unstable and high-risk surgical patients. We also illustrate an example of a secondary AEF with highly specific albeit rare radiologic picture from our institution.

CT-assisted sympathicolysis as an additional minimally invasive therapeutic option in primary focal plantar hyperhidrosis.

PURPOSE: The purpose of this retrospective study was to evaluate the benefit of lumbar computed tomography-assisted sympathicolysis (CTSy) in patients with primary focal hyperhidrosis of the feet. METHODS: A lumbar CTSy was conducted on 35 patients (mean age 36.6 ± 11.9 years) with primary focal hyperhidrosis of the feet, who experienced persistent symptoms after all conservative treatment options had been exhausted. The patients evaluated the severity of their symptoms before the intervention, 2 days after the intervention, and 6 and 12 months after the intervention on the basis of a Dermatology Quality of Life Index(©) (DLQI) and side effects experienced. RESULTS: The interventions performed led to a statistically significant decrease in the preinterventional severity of symptoms 2 days after the intervention, and 6 and 12 months after CTSy (p < 0.05). No major complications occurred. As the most common side effect, 12 of the patients reported compensatory sweating. CONCLUSIONS: After conservative measures have been exhausted or as a complement to the existing therapy regimen, CT-assisted sympathicolysis represents a therapeutic option low in side effects that provides a marked benefit to patients with primary, focal hyperhidrosis.

Endovascular treatment of aneurysms of the popliteal artery by a covered endoprosthesis.

PURPOSE: The current gold standard of popliteal artery aneurysm (PAA) treatment is saphenous vein bypass grafting. The aim of this retrospective single-center study is to investigate the safety and efficacy in the treatment of PAA by an endovascular implanted covered endoprosthesis. MATERIALS AND METHODS: Ten patients, mean age 64.6 (range, 52-78) years, with PAA were treated with an expanded Polytetrafluoroethylen (ePTFE)-covered stent graft (Viabahn(®), W.L. Gore and Associates Inc, Flagstaff, AZ, USA). In median, 1.4 prostheses were implanted with a median length of 180 mm. Follow-up visits included determination of ankle-brachial index (ABI) and color-coded duplex sonography. RESULTS: The technical success rate was 100% (10/10). Clinically, there was an increase in ABI from 0.62 ± 0.17 to 0.91 ± 0.15 postinterventionally and to 0.89 ± 0.16 after an average follow-up of 24.7 months. During the follow-up period, 2 (20%) stent occlusions occurred; both of them were treated with a bypass graft. CONCLUSION: The treatment of PAA with covered endoprosthesis is a safe and effective alternative to open surgical therapy, where open surgical therapy is contraindicated or patient refused open surgery.

Treatment of a Bilateral Sacral Insufficiency Fracture with CT-Guided Balloon Sacroplasty.

Fractures of the os sacrum can be the cause of severe pain and immobility. A common cause of insufficiency fractures is osteoporosis. In elderly and multimorbid patients, the complications of conservative therapy can sometimes be severe. In the meantime, good outcomes with regard to pain reduction and improved mobility are achieved with CT-assisted balloon sacroplasty. We report on the successful simultaneous treatment of a bilateral osteoporosis-related insufficiency fracture of the sacrum.

Transpopliteal balloon-assisted excimer-laser atherectomy for the treatment of chronic femoropopliteal occlusions: feasibility and initial results.

PURPOSE: Recanalization of chronic total occlusions (CTOs) of the femoropopliteal arteries depends on a successful lesion crossing with the guide wire. The aim of this retrospective study was to evaluate the safety, feasibility, and the primary results of retrograde recanalization of CTOs with balloon-assisted excimer-laser atherectomy (ELA) via a transpopliteal approach after failed antegrade attempts. METHODS: A total number of 15 patients (10 male, 5 female) with a mean age of 68.5 years (range: 43-91 years) treated with retrograde transpopliteal ELA in the years 2009-2012 were included retrospectively. After unsuccessful antegrade recanalization attempts with conventional guide wires and catheters, patients were treated with a retrograde recanalization attempt via a transpopliteal access using an excimer laser, followed by pressure-only balloon angioplasty (POBA). The mean length of the CTOs in the femoropopliteal arteries was 17.8 ± 5.4 cm (range: 9-29 cm). RESULTS: Technically successful recanalization was achieved in 14 of 15 patients. Provisional stenting was done in two cases. There were no major adverse events regarding the laser atherectomy or popliteal access site. One acute reocclusion was observed in the first 48 hours after intervention. The ankle-brachial Index increased from preinterventional 0.45 ± 0.07 to 0.77 ± 0.29 (P < 0.05) in the follow-up period (1.5 months), resulting in a primary patency of 80%. CONCLUSION: The retrograde ELA for recanalization of chronic femoropopliteal occlusions via a popliteal access turned out to be a safe and effective procedure with promising primary results. Thus it may be an endovascular treatment option for long chronic occlusions after failed antegrade recanalization or in patients who are not suitable for surgery.