Early Tibial Vessel Recoil Following Treatment With the Bare Temporary Spur Stent System: Results From the DEEPER OUS Vessel Recoil Substudy.

PURPOSE: Vessel recoil is a common phenomenon occurring in the tibial vessels following balloon angioplasty. This study examined the occurrence and short-term impact of acute vessel recoil in a subset of patients treated with retrievable scaffold therapy (RST) via the Spur Peripheral Retrievable Scaffold System (Spur). METHODS: Patients with tibial disease underwent angiography immediately following RST, and then 15 minutes post-treatment. Vessel recoil was defined as a ≥10% decrease in lumen diameter after 15 minutes. Recoil was further analyzed by late lumen loss method, subsegmental late lumen loss method, and smallest segment to same segment method. Patient and vessel characteristics were evaluated. Functional recoil (acute vessel spasm), defined as no significant change in minimal lumen diameter (MLD) at baseline compared with 15 minutes post-treatment, was also evaluated. RESULTS: Of the 38 patients (40 lesions; 33 men [87%]; mean [SD] age 75.3 [8.2] years; 26 (68.4%) with diabetes mellitus); recoil was noted in 42.5% of vessels. Prior to treatment, 13 lesions (32.5%) were total occlusions, the mean lesion length was 64.7±30.4 mm, and 27.5% (11/40) were moderate or severely calcified. Mean treated lesion length was 97.8±39.6 mm. For lesions evaluable by duplex ultrasound, 86.7% of vessels (26/30) were patent at 6 months. There was no significant difference in patency between lesions with recoil and lesions without recoil (81.8% vs 89.5%); there was a trend toward patency in the non-recoil group. Two lesions had functional recoil (acute vessel spasm) and were patent at 6 months. There was no statistically significant correlation of recoil to comorbidities or lesion characteristics, including calcification, for which there was also no correlation to patency. CONCLUSION: Vessel recoil was noted in 42.5% of vessels treated with RST, whereas previous published rates with balloon angioplasty demonstrated vessel recoil up to 97%, suggesting that RST may impact vessel recoil. This exploratory study did not demonstrate a correlation between vessel recoil and patency at 6 months. CLINICAL IMPACT: Retrievable scaffold therapy may replace scoring devices and cutting devices for vessel preparation before definite (drug) therapy. Retrievable scaffold therapy supplements already established vessel preparation strategies in order to follow the concept of leaving nothing behaind. A temporary retrievable scaffold for changing vessel compliance and potentially releasing antiproliferative drugs represents a new interventional concept.

Retrospective Case Control Matched Comparison of the Antegrade Versus Retrograde Strategy After Antegrade Recanalisation Failure in Complex de novo Femoropopliteal Occlusive Lesions.

OBJECTIVE: To investigate dissection severity, need for bailout stenting and limb outcomes in patients undergoing antegrade vs. retrograde revascularisation. METHODS: Consecutive patients who underwent either antegrade or retrograde revascularisation after failed antegrade recanalisation of long femoropopliteal chronic total occlusion (CTO) due to symptomatic peripheral artery disease between January 2017 and June 2022 were studied. Retrospective case control matching was used to adjust for lesion length and calcification using the peripheral artery calcification scoring system (PACSS). Procedural outcomes included severity of dissection (Type A to F dissections, numerically graded on a scale from 0 - 6 with increasing severity) after angioplasty and number and location of stents needed to be implanted during the index procedure. Additionally, clinically driven target lesion revascularisation (CD-TLR) and major (above ankle) amputation rates were assessed during follow up. RESULTS: A total of 180 patients were analysed who underwent antegrade (n = 90) or retrograde after failed antegrade (n = 90) recanalisation. The median patient age was 76.0 (interquartile range [IQR] 67.0, 82.0) years and 76 (42.2%) were female. Moreover, 78 patients (43.3%) had intermittent claudication, whereas 102 (56.7%) had chronic limb threatening ischaemia (CLTI). The mean lesion length was 30.0 (IQR 24.0, 36.0) cm with moderate to severe (3.0 [IQR 2.0, 4.0]) lesion calcification. Dissection severity after angioplasty was higher in the antegrade than retrograde after failed antegrade recanalisation group (4.0 [IQR 3.0, 4.0] vs. 3.0 [IQR 2.0, 4.0]; p < .001). Additionally, the number of stents in all segments and the rate of bailout stenting in popliteal segments was significantly higher with the antegrade strategy (2.0 [IQR 1.0, 3.0] vs. 1.0 [IQR 0, 2.0], p < .010; and 37% vs. 14%, p < .001). During a median follow up of 1.48 (IQR 0.63, 3.09) years, CD-TLR rates (p = .90) and amputation rates in patients with CLTI (p = .15) were not statistically significant. CONCLUSION: In complex femoropopliteal CTOs, retrograde after failed antegrade recanalisation, is safe for endovascular revascularisation, which in experienced hands may result in less severe dissections and lower rates of stent placement. However, considering the relatively short follow up, CD-TLR and amputation rates were not statistically different between the two approaches. [German Clinical Trials Register: DRKS00015277.].

Ten Year Time Trends of Amputation Surgery in Peripheral Arterial Disease in Germany: Before and During the COVID-19 Pandemic.

OBJECTIVE: Peripheral arterial disease (PAD) has been associated with suboptimal treatment, high mortality, and high amputation rates. It is unclear how the COVID-19 (coronavirus disease 2019) pandemic affected this development in a long term context. METHODS: This is a registry based, retrospective, nationwide cohort study including patients hospitalised with PAD as a main or secondary diagnosis and amputation surgery between 2012 - 2021 in Germany. Primary endpoints were population wide major and minor amputation rates, in hospital death, and in hospital mortality rates. Secondary endpoints were same admission revascularisations and in hospital death in the event of complications, i.e., failure to rescue (FTR). Pre-pandemic and pandemic trends, focusing on lockdown periods, were analysed. RESULTS: A total of 365 926 patient records with PAD and amputation surgery were analysed. The median patient age was 75 years and 28.8% were female. Overall population wide amputation and in hospital mortality rates (monthly decrease -0.002/100 000, p < .001, and -0.001/100 000, p< .001, respectively) and in hospital mortality rate (8.0% for 2012 - 2014 vs. 6.5% for 2020 - 2021; p < .001) declined between 2012 and 2020. Concurrently, same admission revascularisations increased (41.0% for 2012 - 2014 vs. 47.0% for 2020 - 2021; p < .001), while FTR decreased in a subset of complications (acute ischaemia, major bleeding, compartment syndrome, and mesenterial ischaemia). In the first pandemic lockdown, there was a temporary trend change to higher major amputations rates (+0.02/100 000; p < .001) and higher in hospital mortality rates (+0.007/100 000; p < .001), which changed to a decrease as of the second lockdown (-0.03/100 000, p = .034, and -0.010/100 000, p < .001, respectively) in an interrupted time series analysis. There was no statistically significant change in observed amputation rates during lockdowns, while observed in hospital mortality rates decreased by 12.0% in the first lockdown (0.22/100 000 vs. 0.25/100 000; p = .005) compared with reference periods of the two previous years. CONCLUSION: Between 2012 and 2021, pre-pandemic trends toward decreasing population wide overall amputation rates, fewer major amputations, more amputation related revascularisation procedures, and lower in hospital mortality were maintained despite a temporary trend to increased major amputations and in hospital mortality during the first COVID-19 related lockdown in Germany.

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.

Best crossing of peripheral chronic total occlusions.

Together with colleagues from different disciplines, including cardiologists, interventional radiologists and vascular surgeons, committee members of the of the German Society of Angiology (Deutsche Gesellschaft für Angiologie [DGA]), developed a novel algorithm for the endovascular treatment of peripheral chronic total occlusive lesions (CTOs). Our aim is to improve patient and limb related outcomes, by increasing the success rate of endovascular procedures. This can be achieved by adherence to the proposed crossing algorithm, aiding the standardization of endovascular procedures. The following steps are proposed: (i) APPLY Duplex sonography and if required 3D techniques such as computed tomography or magnetic resonance angiography. This will help you to select the optimal access site. (ii) EVALUATE the CTO cap morphology and distal vessel refilling sites during diagnostic angiography, which are potential targets for a retrograde access. (iii) START with antegrade wiring strategies including guidewire (GW) and support catheter technology. Use GW escalation strategies to penetrate the proximal cap of the CTO, which may usually be fibrotic and calcified. (iv) STOP the antegrade attempt depending on patient specific parameters and the presence of retrograde options, as evaluated by pre-procedural imaging and during angiography. (v) In case of FAILURE, consider advanced bidirectional techniques and reentry devices. (vi) In case of SUCCESS, externalize the GW and treat the CTO. Manage the retrograde access at the end of the endovascular procedure. (vii) STOP the procedure if no progress can be obtained within 3 hours, in case of specific complications or when reaching maximum contrast administration based on individual patient's renal function. Consider radiation exposure both for patients and operators. In this manuscript we systematically follow and explain each of the steps (i)-(vi) based on practical examples from our daily routine. We strongly believe that the integration of this algorithm in the daily practice of endovascular specialists, can improve vessel and patient specific outcomes.

PERFORMANCE 1 study: Novel carotid stent system with integrated post-dilation balloon and embolic protection device.

OBJECTIVES: The PERFORMANCE I study was designed to evaluate the safety and feasibility of the Neuroguard IEP® System, a novel carotid stent system with an integrated embolic filter and post-dilatation balloon, to treat clinically significant carotid artery stenosis. BACKGROUND: The risk of major adverse events during carotid artery stenting is comparable to carotid endarterectomy, however, the risk of minor stroke remains higher with stenting. METHODS: In total, 67 patients undergoing carotid artery stenting were enrolled at nine centers in Europe. Follow-up assessments included neurological exams, duplex ultrasound, 12-lead electrocardiogram, and cardiac enzyme analysis. The primary endpoint was the 30-day composite rate of stroke, death, and myocardial infarctions versus a prespecified performance goal. Secondary endpoints included procedure success, device success, and target lesion revascularization. RESULTS: The study population was predominantly male (74.6%) with a mean age of 69.3 ± 8.9 years and 67% of subjects met at least one criterion placing them at an elevated risk for adverse events following carotid endarterectomy. All patients were treated successfully with the study device. There were no deaths or strokes within 30 days of the index procedure. One subject (1.5%) experienced a non-ST elevation myocardial infarction at day 17. The primary endpoint was met with a 30-day major adverse events rate of 1.5% (1/67). Through 12-month follow-up, there were no strokes, neurological deaths, target lesion revascularizations, or instances of in-stent-restenosis. CONCLUSIONS: Results from this study demonstrate the Neuroguard IEP system is safe and feasible with a stroke/death rate of 0% at 30 days. A large pivotal study is currently underway.

First Experience With The GoBack-Catheter For Successful Crossing of Complex Chronic Total Occlusions in Lower Limb Arteries.

PURPOSE: To evaluate the use of the GoBack-catheter (Upstream Peripheral Technologies) in complex revascularizations in lower limb arteries. MATERIALS AND METHODS: In this retrospective single-center study, the results of the first 100 consecutive patients including 101 limb-revascularizations, performed between May 2018 and July 2020 with the study device, were analyzed. In all cases, guidewire-crossing failed, and all lesions were chronic total occlusions (CTO), either de novo, reocclusions, or in-stent reocclusions. Successful crossing was defined as passing the CTO using the study device. Patency at discharge and after 30 days was defined as less than 50% restenosis on duplex sonography, without target lesion revascularization. RESULTS: Median lesion length was 24 cm and 38 patients (37.6%) had a calcium grading according to the peripheral arterial calcium scoring system (PACSS) of 4 or 5. In 20.8% of patients, an occluded stent was treated. CTOs involved the femoropopliteal segment in 91.1%, iliac arteries in 5.9%, and tibial arteries in 7.9%. The GoBack-catheter was employed for entering into or crossing through parts or the full length of a CTO or an occluded stent as well as for re-entering into the true lumen after subintimal crossing. The device was used via contralateral and ipsilateral antegrade as well as retrograde access with an overall technical success rate of 92.1%. In 3 patients minor bleeding occurred at the crossing or re-entry site, which were managed conservatively. Thirty-day adverse limb events comprised minor amputations in 4 patients (4.0%), 1 major amputation (1.0%), and reocclusions in 7 limbs (6.9%). CONCLUSION: The new GoBack-catheter offers versatile endovascular applicability for complex CTO recanalization in a broad range of peripheral vascular interventions with a high technical success and low complication rate.

Percutaneous Femoropopliteal Bypass: 2-Year Results of the DETOUR System.

PURPOSE: This study investigated the 2-year safety and effectiveness of the PQ Bypass DETOUR system as a percutaneous femoropopliteal bypass. MATERIALS AND METHODS: Seventy-eight patients with 82 long-segment femoropopliteal lesions were enrolled in this prospective, single-arm, multicenter study. The DETOUR system deployed Torus stent grafts directed through a transvenous route. Eligible patients included those with lesions of >10 cm and average of 371±55 mm. Key safety endpoints included major adverse events (MAEs) and symptomatic deep venous thrombosis in the target limb. Effectiveness endpoints included primary patency defined as freedom from ≥50% stenosis, occlusion, or clinically-driven target vessel revascularization (CD-TVR), primary assisted, and secondary patency. RESULTS: Chronic total occlusions and severe calcium occurred in 96% and 67% of lesions, respectively. Core laboratory-assessed total lesion length averaged 371±51 mm with a mean occlusion length of 159±88 mm. The rates of technical and procedural success were 96%, with satisfactory delivery and deployment of the device without in-hospital MAEs in 79/82 limbs. The MAE rate was 22.0%, with 3 unrelated deaths (4%), 12 CD-TVRs (16%), and 1 major amputation (1%). Deep venous thrombosis developed in 2.8% of target limbs, and there were no reported pulmonary emboli. Primary, assisted primary, and secondary patency rates by the Kaplan-Meier analysis were 79±5%, 79±5%, and 86±4%, respectively. CONCLUSIONS: The PQ Bypass DETOUR system is a safe and effective percutaneous alternative to femoropopliteal open bypass with favorable results through 2 years. The DETOUR system provides a durable alternative to conventional endovascular modalities and open surgery for patients with long, severely calcified, or occluded femoropopliteal lesions.

Orbital Atherectomy Prior to Drug-Coated Balloon Angioplasty in Calcified Infrapopliteal Lesions: A Randomized, Multicenter Pilot Study.

PURPOSE: Optimal balloon angioplasty for infrapopliteal lesions is often limited by severe calcification, which has been associated with decreased procedural success and lower long-term patency. MATERIALS AND METHODS: This was a prospective, randomized, multicenter pilot trial that included adult subjects with calcified lesions located from the popliteal segment below the knee (BTK) joint to within 5 cm above the ankle with ≥70% diameter stenosis by angiography. Patients were randomized 1:1 to undergo orbital atherectomy (OA) with adjunctive drug-coated balloon (DCB) angioplasty versus plain balloon angioplasty (BA) and DCB angioplasty (control). The periprocedural and 12 month outcomes of both procedures were compared. RESULTS: Overall, 66 subjects (OA + DCB = 32 vs control = 34) were included in an intention to treat analysis. Baseline demographics and lesion characteristics were well-balanced. The mean lesion length was 101.3 mm (SD = 72.8 mm) and 78.8 (SD = 61.0 mm) in the OA + DCB and control groups, respectively, with almost all lesions having severe calcification per the Peripheral Academic Research Consortium (PARC) criteria. Chronic total occlusions (CTOs) were present in 43.8% and 35.3% of the patients in the OA + DCB and control groups, respectively. The technical success of OA + DCB versus DCB was 81.8% and 89.2%, respectively, with 3 slow flow/no reflow, 1 perforation, 1 severe dissection occurred in OA + DCB group, and one distal embolization occurred in the control group. The target lesion primary patency rate was numerically higher in the OA + DCB versus control group at 6 (88.2% vs 50.0%, p=0.065) and 12 month follow-up (88.2% vs 54.5%, p=0.076). The 12 month freedom from major adverse events, clinically-driven target lesion revascularization, major amputation, and all-cause mortality rates were similar between both groups. CONCLUSION: The results of the Orbital Vessel PreparaTIon to MaximIZe Dcb Efficacy in Calcified BTK (OPTIMIZE BTK) pilot study indicated that utilization of OA + DCB is safe for infrapopliteal disease. Further prospective adequately powered studies should investigate the potential benefit of combined OA + DCB for BTK lesions.

Safety and Efficacy of All Comers Treated with a Paclitaxel Coated Balloon for Below Knee Intervention.

OBJECTIVE: Data on paclitaxel coated balloons (PCBs) for below knee (BTK) angioplasty exhibited conflicting efficacy results, and previous meta-analyses suggested an increased mortality and amputation risk highlighting the need for further research. The aim of this study was to investigate safety and efficacy of PCBs for BTK interventions in a real world cohort. METHODS: Within a single centre cohort study, 552 consecutive patients were included undergoing BTK interventions with and without PCB use. Two year safety and efficacy results were compared in unadjusted and propensity score matched (PSM) analysis. RESULTS: BTK interventions were performed in 157 patients with PCB angioplasty (100% Lutonix 0.014 inch drug coated balloon; Bard Lutonix, New Hope, MN, USA) and 395 patients with plain old balloon angioplasty (POBA). The majority of interventions (> 70%) were performed for chronic limb threatening ischaemia. Mean lesion length was 20.8 ± 12.6 cm; 61.2% in the PCB and 66.7% in the POBA group were occlusions. In the PCB group, more procedures were performed for re-stenotic lesions than POBA (28.5 vs. 17.2%). In PSM analysis (128 matched pairs), the primary efficacy endpoint was freedom from clinically driven target lesion revascularisation (CD TLR), which occurred in 70.1% in the PCB and 73.1% in the POBA group at one year (p = .85; McNemar test). Survival analysis suggested lower rates of major amputations in the PCB group in unadjusted (94.4% ± 2.1 vs. 89.2% ± 1.9 in the POBA group) and PSM analyses (97.2% ± 1.6 vs. 89.3% ± 3.5) through two years, while no differences were seen for CD TLR and all cause mortality between the groups. CONCLUSION: In this all comer analysis, PCBs were found to be safe for BTK interventions with a signal towards lower amputation rates but no benefit was seen for repeat revascularisation.

Six-month pivotal results of tack optimized balloon angioplasty using the Tack Endovascular System in below-the-knee arteries.

OBJECTIVE: No vascular implant is commercially available in the United States to treat post-angioplasty dissections in below-the-knee (BTK) arteries. The Tack Endovascular System (Intact Vascular, Wayne, Pa) is purpose-built to repair postpercutaneous transluminal angioplasty (PTA) BTK dissections. A trial was conducted to investigate the safety and efficacy of the first-of-a-kind implantable BTK device to treat post-PTA dissections in the setting of critical limb ischemia. METHODS: The present prospective, single-arm, multicenter study evaluated the Tack Endovascular System for treating post-PTA dissections in the mid/distal popliteal, tibial, and peroneal arteries. The primary safety endpoint was major adverse limb events (MALE) plus perioperative death (POD), assessed at 30 days after the index procedure. The primary efficacy endpoint was a composite of MALE at 6 months and POD. The unpowered secondary endpoint was primary patency at 6 months. With no available on-label comparator, the primary endpoints of the present trial were determined using objective performance goals from a systematic literature search. The secondary endpoints included Tacked segment patency and target limb salvage at 6 months. The 6-month results are reported. RESULTS: Of the 233 patients enrolled, 117 (50.2%) had Rutherford class 5 and 78 (33.5%) had Rutherford class 4. A total of 341 post-PTA dissections were treated. Each patient received at least one Tack implant, and 100% of the dissections resolved according to the angiographic core laboratory findings. The primary safety and efficacy endpoints were both met. The rate of MALE plus POD at 30 days was 1.3% (3 of 228) and freedom from MALE at 6 months plus POD at 30 days was 95.6% (196 of 205). The 6-month Tacked segment patency was 82.1% (247 of 301) and target limb salvage was 98.5% (202 of 205). The Kaplan-Meier freedom from clinically driven target lesion revascularization and amputation-free survival at 6 months was 92.0% and 95.7%, respectively. Rutherford improvement was reported in 79.4% (158 of 199). Most (90 of 122; 73.8%) preexisting wounds had healed or were improving. CONCLUSIONS: The Tack Endovascular System is safe and effective for treating post-PTA BTK dissections through 6 months, with favorable rates of MALE plus POD, patency, clinically driven target lesion revascularization, limb salvage, and wound healing.

Type II endoleak and aortic aneurysm sac shrinkage after preemptive embolization of aneurysm sac side branches.

OBJECTIVE: Type II endoleak (T2EL) is the most common endoleak after endovascular aneurysm repair (EVAR). Its optimal management has been controversially discussed. Thus, preliminary selective embolization of aneurysm sac side branches (ASSBs) has been adopted to prevent T2EL. Our goal was to determine the rate of T2EL and the diameter decrease of abdominal aortic aneurysms (AAAs) after EVAR performed after preemptive embolization of ASSBs. METHODS: From September 2014 to September 2019, 139 patients with AAAs underwent percutaneous ASSB embolization before EVAR. Follow-up imaging studies were performed at 1 and 6 months and annually thereafter. The end points included freedom from T2EL, AAA sac shrinkage, T2EL-related reinterventions, and all-cause mortality. RESULTS: The mean follow-up was 23 ± 16 months (range, 1-61 months). The patients had had a median of five (range, one to eight) patent ASSBs found on preoperative imaging studies. After completion of embolization, 76.4% of the initially patent ASSBs were occluded, with no major procedure-related complications. Follow-up imaging studies showed T2ELs in seven patients (5%), with an aneurysm sac increase seen in six of these patients. The number of ASSBs remaining patent after embolization was the only discriminative factor in patients with and without T2EL. Six T2EL-related reinterventions were performed during follow-up. Most patients (n = 91; 86.7%) had experienced aneurysm sac shrinkage, and the mean diameter reduction was 9.2 ± 7.7 mm (P < .001) in all patients with follow-up data available. One aneurysm-related death occurred within 30 days after EVAR. CONCLUSIONS: Preemptive embolization of ASSBs for patients with AAAs is safe and effective in preventing T2ELs after EVAR. Aneurysm sac shrinkage was observed in a high proportion of patients.

Performance of the Wingman catheter in peripheral artery chronic total occlusions: Short-term results from the international Wing-It trial.

OBJECTIVES: To determine the safety and effectiveness of a peripheral artery chronic total occlusion (CTO) crossing catheter following failed crossing attempts with standard guidewires. BACKGROUND: CTO crossing remains a challenge during peripheral artery interventions. METHODS: In this prospective, international, single-arm study, patients with a peripheral artery CTO that was uncrossable with standard guidewires were treated with a crossing catheter (Wingman, Reflow Medical). The primary efficacy endpoint of CTO crossing success was compared to a performance goal of 70.7%. The primary composite safety endpoint (major adverse event [MAE], clinically significant perforation or embolization, or grade C or greater dissection) was assessed over a 30-day follow-up period and compared to a performance goal of 13.0%. RESULTS: A total of 85 patients were treated using the Wingman catheter for peripheral artery CTO crossing. Key patient characteristics were mean age of 71±9 years, 66% male, and mean lesion length of 188±94 mm in the superficial femoral artery (71%), popliteal artery (15%), or infrapopliteal arteries (14%). Both primary endpoints of the trial were met¾CTO crossing success was 90% (lower confidence limit=82.5%) and 5 primary safety events occurred in 4 (4.8%) patients (upper confidence limit=10.7%). Over 30 days of follow-up, Rutherford score decreased by at least 2 categories in 74% patients; the percentage of patients with normal hemodynamics assessed with the ankle-brachial index increased from 1% to 51%. CONCLUSIONS: Among patients with a CTO that was unable to be crossed with a standard guidewire, the Wingman catheter was able to cross 90% of occlusions with a favorable safety profile.

First-in-Human Clinical Application of the Medyria TrackCath System in Endovascular Repair of Complex Aortic Aneurysms (ACCESS Trial): A Prospective Multicenter Single-Arm Clinical Trial.

PURPOSE: The Medyria TrackCath Catheter (MedTCC) is an innovative, thermal convection-based blood flow velocity (BFV) tracking catheter that may be used during complex aortic endovascular procedures for identification and catheterization of target orifices. The ACCESS Trial analyzes the safety and performance of the MedTCC for targeted vessel catheterization to generally evaluate the feasibility of thermal convection-based BFV. MATERIALS AND METHODS: We performed a first-in-human, proof-of-concept, prospective single-arm multicenter clinical trial between March 2018 and February 2019 in patients who underwent endovascular aortic procedures at 4 high-volume centers. During these procedures, the MedTCC was advanced over a guidewire through the femoral access. The D-shape was enfolded in the reno-visceral part of the aorta and target orifices were identified and catheterized with a guidewire via the side port of the MedTCC through BFV tracking. BFV measurements were performed at baseline (Baseline-BFV), alignment to the orifice (Orifice-BFV), and following catheterization (Confirmation-BFV) to prove correct identification and catheterization of target orifices. The procedural success rate, the catheterization success rate, procedure-related parameters, and (serious) adverse events ((S)AE) during the follow-up were analyzed. RESULTS: A total of 38 patients were included in the safety group (SG) and 26 in the performance group (PG). The procedural success rate was 89% (PG), the MedTCC catheterization success rate was 98% (PG). The MedTCC reliably measured BFV changes indicated by significant differences in BFV between Baseline-BFV and Orifice-BFV (p<0.05). Median (interquartile range; IQR) fluoroscopy time per orifice was 5.0 (1.5-8.5) minutes [total surgery 49 (26-74) minutes], median (IQR) contrast agent used per orifice was 1.0 (0-5.0) mL [total surgery 80 (40-100) mL], and median (IQR) MedTCC-based procedural time was 3.0 (2.0-6.0) minutes. There was no device-related SAE. CONCLUSIONS: The ACCESS Trial suggests that BFV measurement allows for reliable target orifice identification and catheterization. The use of MedTCC is safe and generates short fluoroscopy time and low contrast agent use, which in turn might facilitate complex endovascular procedures.

The Influence of 3D Printed Aortic Models on the Evolution of Physician Modified Stent Grafts for the Urgent Treatment of Thoraco-abdominal and Pararenal Aortic Pathologies.

OBJECTIVE: The aim was to describe the outcomes of high risk patients with symptomatic or contained rupture of pararenal (PRAs) and thoraco-abdominal aortic aneurysms (TAAAs) with anatomy unsuitable for commercially available stent grafts who underwent fenestrated endovascular aneurysm repair (FEVAR) using physician modified stent grafts (PMSGs) planned with 3D image analysis software (3DIMAS), and 3D printed aortic models (3DAMs). METHODS: Nineteen consecutive patients (17 male; mean age, 70 ± 9 years) underwent PMSG-FEVAR between 2015 and 2019. 3DAMs to plan the PMSGs were introduced in 2018. End points were all cause mortality, freedom from any endoleak, target vessel patency, and re-intervention. RESULTS: Seven patients (36.8%) were treated with PMSGs using 3DIMAS (three PRAs, three type IV, and one type III TAAAs), and 12 patients (63.2%) received PMSGs using 3DAMs (five PRAs, seven type IV TAAAs). Six patients presented with contained aortic rupture and 13 patients were treated for symptomatic aortic aneurysm. Mean aortic diameter was 72 ± 10 mm. The choice of stent graft for fenestration was the Valiant Captivia Closed Web (Medtronic), except for one patient. Sixteen (84.2%) stent grafts were manufactured with four fenestrations. Technical success was 100%. Seventy-one renovisceral branch vessels were targeted with fenestrations. Mean length of hospital stay was 17.3 ± 10.4 days. Thirty day mortality was 0%. Two patients developed reversible spinal cord injury. Mean follow up was 14.4 months (range 1-52 months). During follow up one non-aneurysm related death occurred, and two successful re-interventions were performed: one to re-establish renal artery patency, and one to treat a type 1c endoleak. CONCLUSION: PMSGs for urgent treatment of pararenal and thoraco-abdominal aortic aneurysms in high risk patients unsuitable for commercially available stent grafts are feasible and safe. 3D printing technology may improve urgent construction of patient specific devices for treatment of complex aortic pathologies and improve outcomes.

COMPARE: prospective, randomized, non-inferiority trial of high- vs. low-dose paclitaxel drug-coated balloons for femoropopliteal interventions.

AIMS: Drug-coated balloons (DCBs) for femoropopliteal interventions have not been tested against each other. We aimed to directly compare efficacy and safety of a high-dose (In.Pact™) vs. low-dose (Ranger™) DCB with nominal paclitaxel densities of 3.5 vs. 2.0 µg/mm2. METHODS AND RESULTS: Within a prospective, multicentre, non-inferiority, clinical trial 414 patients with symptomatic femoropopliteal lesions (Rutherford classification 2-4) were randomly assigned in a 1:1 ratio to endovascular treatment with either high- or low-dose DCB after stratification for lesion length. Primary efficacy and safety endpoints comprised primary patency and freedom from major adverse events (i.e. device and procedure-related deaths through 1 month, major amputations, and clinically driven target lesion revascularization through 12 months). We set a non-inferiority margin of -10% at 12 months. Total occlusions were observed frequently (>40%) and provisional stenting was performed in every fourth intervention. Non-inferiority was determined for both primary efficacy and safety endpoints at 12 months. Primary patency was 81.5% in the high-dose and 83.0% in low-dose DCB group {difference: 1.5% [lower bound of the 90% two-sided confidence interval (CI) -5.2%]; Pnon-inferiority < 0.01}. Freedom from major adverse events was determined in 92.6% in high-dose and in 91.0% in low-dose DCB group [difference -1.6% (lower bound of the 90% two-sided CI -6.5%); Pnon-inferiority < 0.01]. Overall death rate was low (2.0%) and no major amputation occurred. CONCLUSION: Two DCBs with different coating characteristics exhibited comparable results with excellent effectiveness and safety through 12 months for femoropopliteal interventions including a wide range of lesion lengths. CLINICAL TRIAL REGISTRATION: The trial is registered with ClinicalTrials.gov (NCT02701543).

Stroke rate after thoracic endovascular aortic repair using de-airing of stentgrafts with high-volume of saline solution.

Background: Our aim was to determine the rate of ischemic stroke following thoracic endovascular aortic repair (TEVAR) after reducing gas volume released during stentgraft deployment by de-airing of thoracic stentgrafts with high-volume of 0.9% heparinized saline solution. Patients and methods: A single center retrospective analysis of all consecutive patients undergoing TEVAR from 2014 to 2019 was performed. All thoracic stentgrafts were flushed with 120 ml 0.9% heparinized saline solution before implantation, according to our institutional protocol. Endpoints were in-hospital rates of ischemic stroke and spinal cord ischemia (SCI), and all-cause mortality. Results: One hundred and fifty-four patients (mean age: 66.8 ± 13.6 years, 64.9% males) were treated with TEVAR during the study period. Indications for treatment were thoracic aortic aneurysms (n = 75, 48.7%), acute type B aortic dissections (n = 46, 29.9%), aortic arch aneurysms and penetrating aortic ulcers (n = 28, 18.2%), and blunt traumatic aortic injuries (n = 5, 3.2%). Timing of procedure was urgent in 75 patients (48.7%). Proximal landing zone were zone 0-1-2 (n = 75, 48.7%), zone 3 (n = 66, 42.9%) and zone 4 (n = 13, 8.4%). Supra-aortic vessels were revascularized with custom-made fenestrated stentgrafts in 9 patients (5.8%), using chimney technique in 4 patients (2.6%), and with debranching procedures in 19 patients (12.3%). Left subclavian artery was covered without revascularization in 46 patients (29.9%). In-hospital stroke occurred in two patients (1.3%) and SCI in another two patients (1.3%). In-hospital mortality rate was 0.6%. No further in-hospital events were noted. Conclusions: De-airing of stentgrafts with high-volume of 0.9% heparinized saline solution seems to be safe and can be used as an adjunct to keep occurrence of neurological events after TEVAR as low as possible.

Photoablative atherectomy followed by a paclitaxel-coated balloon to inhibit restenosis in instent femoro-popliteal obstructions (PHOTOPAC).

Background: To evaluate the safety and effectiveness of preparing instent femoropopliteal lesion with photoablative laser atherectomy or plain balloon angioplasty (POBA) prior to drug-coated balloon (DCB) angioplasty. Patients and methods: The prospective, multicenter, randomized study enrolled patients with Rutherford-Becker-class (RBC) 1 to 5 and instent lesions located in superficial femoral artery and/or popliteal artery above the knee joint. Primary endpoint was target lesion percent stenosis at 1 year as determined by the angiographic core-laboratory. Secondary endpoints included procedural success, major adverse event rate, clinical improvement and improvement in ankle-brachial index (ABI), clinically-driven target lesion revascularization (CD-TLR), and primary patency rate at until 2-year follow-up. Results: The study was terminated prior to the enrollment goal due to slow enrollment. Thirty patients were included in the laser plus DCB cohort and 31 patients in the control cohort. Primary endpoint was not significantly different (p=0.331). Procedural success was 83.3% and 87.1% for the laser plus DCB and the control cohort, respectively. Serious adverse events at 30 days and 1-year were not statistically different between the two cohorts. For the ABI, significant improvements were present at discharge as well as at the follow-up visits. This was also evident for the RBC at the follow-up visits. One- and two-year freedom from CD-TLR was 86.7% vs. 87.1%, and 63.6% vs. 72%, respectively. Duplex derived primary patency was 90% at 6-months, 65.5% at one year and 56.5% at two year for the laser cohort and 90.3%, 75.9% and 53.8% for the control cohort. Conclusions: Safety of instent photoablative laser atherectomy followed by DCB angioplasty is confirmed by this study. Due to the small sample size, no benefit over POBA as vessel preparation could be shown.

[Surgeon-modified Stent Grafts for Complex Aortic Reconstructions - What is Feasible?] / Surgeon-modified Stentgrafts für komplexe Aortenrekonstruktionen ­ was ist möglich?

BACKGROUND: The close anatomical relationship to the visceral vessels renders the treatment of complex throacoabdominal aortic pathologies challenging. In emergent cases, off-the-shelf stent grafts and parallel techniques are feasible treatment options. Alternatively, the treating surgeon can alter a conventional stent graft, creating a so-called surgeon-modified stent graft (SMSG) to adapt it to the complex aortic pathology. The aim of this publication is to present the possibilities and results of this method. RESULTS: The location of SMSG's fenestrations can be determined after manual measurements of the centerline of flow reconstructions of the aortic computed tomography-angiography. The planning of the SMSG can be simplified and standardized by creating personalized 3D aortic models, and by using algorithms for the automated determination of the ideal fenestration positions. Most approved stent grafts can be used as platforms for SMSG. Different manufacturing techniques have been described. In addition to simple fenestrations, mini-cuffs, directional branches, and inner branches are used. Furthermore, diameter reducing ties and preloaded catheters could facilitate the implantation. The treatment of complex aortic pathologies using SMSG has achieved good results, with high technical success rate of 90-100%, and low 30-day mortality, especially when compared to open surgical treatment of similar patients. The rate of endoleak of 0-14% was also acceptable. Long-term durability results after treatment with SMSG are not yet available. CONCLUSION: Surgeon-modified stent grafts are safe and feasible for the endovascular treatment of patients with urgent complex thoracoabdominal aortic pathologies. They represent compassionate use and show promising results in the published literature.

One-year results from the DETOUR I trial of the PQ Bypass DETOUR System for percutaneous femoropopliteal bypass.

OBJECTIVE: The objective of this study was to evaluate the 1-year safety and effectiveness outcomes associated with the PQ Bypass DETOUR System (PQ Bypass, Milpitas, Calif) for the percutaneous bypass of long-segment femoropopliteal occlusive disease. METHODS: This prospective, single-arm, multicenter trial enrolled patients with long-segment femoropopliteal arterial disease. The DETOUR System percutaneously deploys modular stent grafts to bypass femoropopliteal lesions through a transvenous route. Eligible patients included those with TransAtlantic Inter-Society Consensus C and D lesions >100 mm in length. The primary safety end point was the major adverse event (MAE) rate through 1 month, defined as the composite of death, clinically driven target vessel revascularization (CD-TVR), or major amputation. The primary effectiveness end point was stent graft patency through 6 months, defined as freedom from stenosis ≥50%, occlusion, or CD-TVR. RESULTS: During a 24-month period, 78 patients (82 limbs) were enrolled. The average core laboratory-measured lesion length was 371 ± 55 mm; 79 of 82 lesions (96%) were chronic total occlusions, and 55 of 82 lesions (67%) had severe calcification. The rates of technical and procedural success measured during the index procedure were both 96%, with satisfactory delivery and deployment of the device without MAEs in 79 of 82 limbs. Through 1 month, there were no deaths or amputations; CD-TVRs occurred in 2 of 81 limbs (3%), and freedom from MAEs was 98% (79/81). The 1-year Kaplan-Meier primary, assisted primary, and secondary patency rates were 81% ± 4%, 82% ± 4%, and 90% ± 3%, respectively. The ankle-brachial index increased an average of 0.25 ± 0.27 between baseline and 1 year (P < .001). Through 1 year, the Kaplan-Meier estimates of freedom from stent graft thrombosis, CD-TVR, and MAE were 84% ± 4%, 85% ± 4%, and 84% ± 4%, respectively. At 1 year, the Rutherford class improved in 77 of 80 limbs (96%), and 65 of 80 (81%) were asymptomatic. Deep venous thrombosis developed in 2 of 79 target limbs (3%) through 1 year, both at the femoropopliteal vein level. There were no instances of pulmonary embolism. CONCLUSIONS: The 1-year results from the DETOUR I trial show that the PQ Bypass DETOUR System is a safe and effective percutaneous treatment option for patients with longer, severely calcified, above-knee femoropopliteal lesions.