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.

[Treatment of chronic limb-threatening ischemia (CLTI) based on BEST-CLI and BASIL-2]. / Therapie der chronischen extremitätenbedrohenden Ischämie.

The rate of vascular recanalizations in CLTI is increasing worldwide. Safety and efficacy of surgical versus endovascular treatment in CLTI patients was investigated in 2 prospective randomized trials with contrasting results. The BEST-CLI trial randomized 1830 patients with CLTI, the Bypass versus Angioplasty for Severe Ischaemia of the Leg (BASIL-2) trial included 345 patients with CLTI. Best-CLI evaluated outcome events as the primary endpoint, which includes major reinterventions in addition to major amputations and death. Only half of the CLTI patients received a crural intervention or surgery. There were no differences in major amputations or death. After a median follow-up (FU) of 2,7 years, the surgery group showed significantly better results compared to the endovascular group, due to fewer re-interventions. BASIL-2 used amputation-free survival as the primary outcome and only included patients with lower leg lesions. After a median FU of 40 months, endovascular therapy was found to be superior. The extremely high mortality rate was remarkable in both studies. The BEST-CLI study represents CLTI patients only to a limited degree, whereas the BASIL-2 study presents the treatment of CLTI patients with below-the-knee-lesions quite well. Both studies confirm that patients with CLTI should be treated in specialized centers that offer both crural surgery and endovascular therapy. Cardiovascular risk factor management must play a more important role in reducing the high mortality associated with CLTI.

The MULAN Trial - RCT on the use of MUsic in Cath-Lab to reduce ANxiety during peripheral vascular interventions.

Background: The purpose was to analyze the use of classical music to reduce procedure-related anxiety while conducting percutaneous transluminal angioplasty in patients with peripheral artery disease. Patients and methods: A total of 155 patients were analyzed in this single center randomized controlled trial. Procedure-related anxiety was assessed by a numerical rating scale (NRS, 0-10) and by recording of physiological parameters at three different points in time. A survey was conducted after the intervention. Results: This study showed that the patients listened to music overcame their procedure-related anxiety more quickly than the patients in the control group. The NRS at second timepoint was significantly reduced in intervention group compared to control group (p<0.01; r=0.2). Most participants stated that they would like to listen to music during possible future interventions. Conclusions: Classical music during endovascular interventions reduced procedure-related anxiety measured as greater reduction in NRS values in intervention group as well as in results of questionnaire performed post procedurally in PAD patients.

Randomized Trial Comparing a Stent-Avoiding With a Stent-Preferred Strategy in Complex Femoropopliteal Lesions.

BACKGROUND: Limited comparative data exist on different interventional strategies for endovascular revascularization of complex femoropopliteal interventions. OBJECTIVES: In this study, the authors aimed to compare a stent-avoiding (SA) vs a stent-preferred (SP) strategy, promoting optimal lesion preparation and the use of drug-eluting technologies in both arms. METHODS: Within a prospective, multicenter, pilot study, 120 patients with symptomatic complex femoropopliteal lesions (Rutherford classification 2-4, mean lesion length 187.7 ± 78.3 mm, 79.2% total occlusions) were randomly assigned in a 1:1 fashion to endovascular treatment with either paclitaxel-coated balloons or polymer-coated, paclitaxel-eluting stents. Lesion preparation including the use of devices for plaque modification and/or removal was at the operators' discretion in both treatment arms. RESULTS: In the SA group, lesion preparation was more frequently performed (71.7% SA [43/60] vs 51.7% [31/60] SP; P = 0.038) with a high provisional stenting rate (48.3% [29/60]). At the 12-month follow-up, primary patency was 78.2% (43/55) in the SA group and 78.6% (44/56) in the SP group (P = 1.0; relative risk: 0.995; 95% CI: 0.818-1.210). Freedom from major adverse events was determined in 93.1% (54/58) in the SA group and in 94.9% (56/59) in the SP group (P = 0.717; relative risk: 0.981; 95% CI: 0.895-1.075), with all adverse events attributable to clinically driven target lesion revascularization. CONCLUSIONS: Both endovascular strategies promoting lesion preparation before the use of drug-eluting devices suggest promising efficacy and safety results in complex femoropopliteal procedures with a high proportion of total occlusions through 12 months. Ongoing follow-up will show whether different results emerge over time. (Best Endovascular Strategy for Complex Lesions of the Superficial Femoral Artery [BEST-SFA]; NCT03776799).

[Clinical acute and emergency medicine curriculum-focus on internal medicine : Recommendations for advanced training in internal medicine in the emergency department]. / Curriculum Klinische Akut- und Notfallmedizin ­ Schwerpunkt Innere Medizin : Empfehlung zu Weiterbildungsinhalten der Inneren Medizin in der Notaufnahme.

In Germany, physicians qualify for emergency medicine by combining a specialty medical training-e.g. internal medicine-with advanced training in emergency medicine according to the statutes of the State Chambers of Physicians largely based upon the Guideline Regulations on Specialty Training of the German Medical Association. Internal medicine and their associated subspecialities represent an important column of emergency medicine. For the internal medicine aspects of emergency medicine, this curriculum presents an overview of knowledge, skills (competence levels I-III) as well as behaviours and attitudes allowing for the best treatment of patients. These include general aspects (structure and process quality, primary diagnostics and therapy as well as indication for subsequent treatment; resuscitation room management; diagnostics and monitoring; general therapeutic measures; hygiene measures; and pharmacotherapy) and also specific aspects concerning angiology, endocrinology, diabetology and metabolism, gastroenterology, geriatric medicine, hematology and oncology, infectiology, cardiology, nephrology, palliative care, pneumology, rheumatology and toxicology. Publications focussing on contents of advanced training are quoted in order to support this concept. The curriculum has primarily been written for internists for their advanced emergency training, but it may generally show practising emergency physicians the broad spectrum of internal medicine diseases or comorbidities presented by patients attending the emergency department.

Compression Therapy in Acute Deep Venous Thrombosis of the Lower Limb and for the Prevention of Post-Thrombotic Syndrome.

BACKGROUND: After an acute deep venous thrombosis (DVT) of the lower limb, 20% to 63% of patients develop post-thrombotic syndrome (PTS). In this review, we address the efficacy of compression therapy in the treatment of acute DVT of the lower limb, and for the prevention of PTS. METHODS: 12 randomized controlled trials (RCTs) and one meta-analysis, with a total of 3751 patients, were identified in a structured literature search. RESULTS: Two RCTs showed that adding compression therapy to drug treatment in the first 9 days of the acute phase of lower limb DVT led to more rapid pain relief (p<0.050) and less swelling (remaining difference in circumference, 1 cm versus 3 cm, p<0.050). As for the prevention of PTS, four RCTs showed a short-term benefit or no benefit of compression therapy. In three further RCTs, medical compression stockings (MCS) brought about a 16% to 27% absolute reduction of the frequency and severity of PTS (47% vs. 20 %, p<0.001; 40% vs. 21% (95% confidence intervals [29.9; 50.1] and [12.7; 29.5], respectively; and 58% vs. 42%, relative risk [RR] 0.73 [0,55; 0.96]). The benefit of MCS was also confirmed in a recent meta-analysis (RR 0.66 [0.44; 0.99], I2 = 88%). Thigh-length MCS were not superior to knee-length MCS for the prevention of PTS (33% vs. 36%, hazard ratio [HR] 0.93 [0.62; 1.41]). Individual, symptomoriented tailoring of the duration of treatment was not inferior to a fixed treatment duration of 24 months (29% vs. 28%; odds ratio [OR] 1.06 [0.78;1.44]). CONCLUSION: Compression therapy relieves symptoms in acute DVT and lessens the frequency and severity of PTS. It is therefore recommended as standard treatment.

Clinical investigation of the GORE drug-coated PTA balloon catheter for CE mark approval.

OBJECTIVES: Paclitaxel-coated balloon angioplasty has been established as the first-line therapy for femoropopliteal artery disease. The primary objectives of the study were to evaluate the performance and the safety of the GORE-DCB Catheter in the treatment of atherosclerotic femoropopliteal lesions in patients with peripheral artery disease for CE-Mark approval. METHODS: Prospective, single-arm, multicenter study with 24 months follow-up. The GORE-DCB Catheter consists of a drug-coated nylon (inner layer)/ePTFE (outer layer) composite balloon. The ePTFE layer is coated with paclitaxel (concentration: 3.5 µg/mm2) and the excipient stearic acid/tromethamine (tris). The primary endpoints were 6-month late lumen loss (LLL) and 30-day of freedom from Major Adverse Events (MAE). RESULTS: Fifty-two subjects were enrolled, 69% men, median age 69 (49-83) years. Acute device success was 100%, the 30-day MAE rate was zero. Study primary endpoint of LLL (-0.17 mm) showed significant superiority compared to the performance goal of uncoated PTA balloon catheters from literature. At 1 and 2 years, primary patency rates were 81.8% and 68.7%, respectively, and freedom from clinically driven target lesion revascularization rates was 87.9% and 83.4%, respectively. CONCLUSION: The study demonstrates that the treatment of lesions in femoropopliteal arteries with the GORE-DCB Catheter is safe and effective.

Endovascular interventions in outpatient care.

Endovascular arterial revascularisations for the treatment of symptomatic peripheral arterial disease are constantly increasing in importance and number due to the changing age structure and high numbers of comorbidities in the German population. Patients with peripheral artery disease are often at increased risk for peri- and post-procedural complications including severe cardiovascular events. Due to limited financial and human resources and considerable risks of hospitalization, endovascular interventions that were previously reserved for hospitalized patients are now progressively considered to be performed as day case procedures. More than one third of these procedures are performed in Germany by internists with a specialization in angiology. In the current position paper the German Society of Angiology endorsed by the European Society of Vascular Medicine, summarizes the requirements and risk factors to be considered for the planning, safe performance and post procedural care of endovascular revascularizations in outpatients. The performance of endovascular procedures for peripheral artery disease both in hospitalised and outpatients should be accompanied by a mandatory quality assurance process that should not only capture procedural data, but also require documentation of complications and longterm outcome.

Intravascular Lithotripsy in Calcified Peripheral Lesions: Single-Center JEN-Experience.

Peripheral artery disease (PAD) shows increasing need for revascularization therapy. Interventional success in calcified lesions is limited. Here, intravascular lithotripsy (IVL), modifying intimal and medial calcium, is a promising treatment approach. A single-center, prospective all-comers registry for patients undergoing peripheral IVL was established to examine treatment success in PAD with severe vessel calcification. Periprocedural safety events as well as short-term and intermediate follow-up clinical data were evaluated. Between December 2018 and January 2021 all consecutive patients receiving peripheral lithotripsy at our center were analyzed. Clinical and angiographic data were evaluated. Angiographic images were analyzed using a semiautomatic software for quantitative vessel analysis. Eighty-five lesions in 61 limbs were treated with IVL in 51 patients presenting with Rutherford classes 2 to 5. Most lesions (68%) were localized in the superficial femoral artery. Mean calcified lesion length was 102.5 mm (10-390 mm), with a median peripheral arterial calcium score of 3, indicating a highly calcified status. In 58% of the patients, IVL was used as a stand-alone therapy. IVL resulted in a mean acute luminal gain of 2.6 ± 0.9 mm, resulting in stenosis reduction by 42.1 ± 15%. Mean ankle brachial index (ABI) improved significantly from 0.6 to 0.8 ( p < 0.0001) on day 1 after the intervention and remained stable at 6 months. This large real-world data of peripheral IVL reports compelling safety in a complex patient cohort. For the first time, clinical follow-up data demonstrated a sustained significant improvement in ABI after 6 months.

A Very Rare Cause of Thrombotic Peripheral Occlusion.

A 45-year-old healthy woman presented with claudication of the right leg. The resting ankle-brachial index (ABI) was reduced to 0.6, and a duplex scan revealed an occlusion of the right popliteal artery. Angiography presented a patent superficial femoral artery that ends above the knee joint. Laterally, there was delayed retrograde contrast filling of the popliteal artery. After exploring the internal iliac artery, we crossed a thrombotic occlusion of a persisting sciatic artery (PSA). Local thrombolysis with recombinant tissue plasminogen activator (1 mg/h) was initiated. The Angiography 18 hours later showed a reduction of thrombotic material and relevant stenosis in the proximal part of the vessel. Residual thrombus and the stenosis were covered by two stentgrafts (Gore Viabahn Endoprosthesis) that were stabilized by an interwoven stent (Supera). Final angiography displayed a patent sciatic artery and a three-vessel run off. Postinterventional ABI was normalized to 1.0. The magnetic resonance imaging 6 days after the intervention demonstrated a patent PSA again and a normal blood flow on the left leg. A PSA should be included in the differential diagnosis of lower limb ischemia or suspected aneurysm formation. We demonstrated the feasibility of an interventional approach with an excellent outcome in this case.

Low-Dose vs High-Dose Paclitaxel-Coated Balloons for Femoropopliteal Lesions: 2-Year Results From the COMPARE Trial.

BACKGROUND: So far only 1-year data have been reported for direct comparisons of paclitaxel-coated balloons (PCBs) using different coating technologies. OBJECTIVES: The aim of this study was to report the 24-month results on the efficacy and safety of low-dose vs high-dose PCBs with nominal paclitaxel densities of 2.0 and 3.5 µg/mm2 and different coating technologies for femoropopliteal interventions from the COMPARE (Compare I Pilot Study for the Treatment of Subjects With Symptomatic Femoropopliteal Artery Disease) trial. Procedural characteristics of clinically driven (CD) target lesion revascularization (TLR) were analyzed. METHODS: Within a prospective, multicenter, clinical trial, 414 patients with symptomatic femoropopliteal lesions (Rutherford categories 2-4, maximum lesion length 30 cm) were randomly assigned in a 1:1 ratio to endovascular treatment with either a low-dose (Ranger) or a high-dose (IN.PACT) PCB after stratification for lesion length. Two-year follow-up included assessment of primary patency (defined as absence of CD TLR or binary restenosis with a peak systolic velocity ratio >2.4 by duplex ultrasound), safety, and functional and clinical outcomes. RESULTS: At 2 years, the Kaplan-Meier estimates of primary patency were 70.6% and 71.4% for the low-dose and high-dose PCBs (log-rank P = 0.96), respectively. One major amputation occurred in the high-dose group, and rates of all-cause mortality (3.6% vs 2.2%; P = 0.55) and CD TLR (17.3% vs 13.0%; P = 0.31) were similar between the groups. Among a total of 57 CD TLRs, 44.6% were performed for reocclusion and 28.1% for in-stent restenosis. Functional and clinical benefits over baseline were sustained in both groups. CONCLUSIONS: The 2-year results of the COMPARE trial demonstrate a sustained treatment benefit of both low-dose and high-dose PCBs for femoropopliteal interventions including a wide range of lesion lengths. (Compare I Pilot Study for the Treatment of Subjects With Symptomatic Femoropopliteal Artery Disease; NCT02701543).

Efficacy of a Drug-Eluting Stent Versus Bare Metal Stents for Symptomatic Femoropopliteal Peripheral Artery Disease: Primary Results of the EMINENT Randomized Trial.

BACKGROUND: A clear patency benefit of a drug-eluting stent (DES) over bare metal stents (BMSs) for treating peripheral artery disease of the femoropopliteal segment has not been definitively demonstrated. The EMINENT study (Trial Comparing Eluvia Versus Bare Metal Stent in Treatment of Superficial Femoral and/or Proximal Popliteal Artery) was designed to evaluate the patency of the Eluvia DES (Boston Scientific, Marlborough, MA), a polymer-coated paclitaxel-eluting stent, compared with BMSs for the treatment of femoropopliteal artery lesions. METHODS: EMINENT is a prospective, randomized, controlled, multicenter European study with blinded participants and outcome assessment. Patients with symptomatic peripheral artery disease (Rutherford category 2, 3, or 4) of the native superficial femoral artery or proximal popliteal artery with stenosis ≥70%, vessel diameter of 4 to 6 mm, and total lesion length of 30 to 210 mm were randomly assigned 2:1 to treatment with DES or BMS. The primary effectiveness outcome was primary patency at 12 months, defined as independent core laboratory-assessed duplex ultrasound peak systolic velocity ratio ≤2.4 in the absence of clinically driven target lesion revascularization or surgical bypass of the target lesion. Primary sustained clinical improvement was a secondary outcome defined as a decrease in Rutherford classification of ≥1 categories compared with baseline without a repeat target lesion revascularization. Health-related quality of life and walking function were assessed. RESULTS: A total of 775 patients were randomly assigned to treatment with DES (n=508) or commercially available BMSs (n=267). Baseline clinical, demographic, and lesion characteristics were similar between the study groups. Mean lesion length was 75.6±50.3 and 72.2±47.0 mm in the DES and BMS groups, respectively. The 12-month incidence of primary patency for DES treatment (83.2% [337 of 405]) was significantly greater than for BMS (74.3% [165 of 222]; P<0.01). Incidence of primary sustained clinical improvement was greater among patients treated with the DES than among those who received a BMS (83.0% versus 76.6%; P=0.045). The health-related quality of life dimensions of mobility and pain/discomfort improved for the majority of patients in both groups (for 66.4% and 53.6% of DES-treated and for 64.2% and 58.1% of BMS-treated patients, respectively) but did not differ significantly. At 12 months, no statistical difference was observed in all-cause mortality between patients treated with the DES or BMS (2.7% [13 of 474] versus 1.1% [3 of 263]; relative risk, 2.4 [95% CI, 0.69-8.36]; P=0.15). CONCLUSIONS: By demonstrating superior 1-year primary patency, the results of the EMINENT randomized study support the benefit of using a polymer-based paclitaxel-eluting stent as a first-line stent-based intervention for patients with symptomatic peripheral artery disease attributable to femoropopliteal lesions. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02921230.

2-Year Results With a Sirolimus-Eluting Self-Expanding Stent for Femoropopliteal Lesions: The First-in-Human ILLUMINA Study.

OBJECTIVES: The aim of the study was to assess 24-month efficacy and safety of a novel drug-eluting stent (DES) for femoropopliteal interventions with an innovative stent design and abluminal reservoir technology releasing the amphilimus formulation (sirolimus plus fatty acid) for efficient drug transfer and optimized release kinetics. BACKGROUND: DES releasing paclitaxel exhibited good patency rates after femoropopliteal interventions. No benefit has been reported when sirolimus or everolimus were used for antiproliferative stent coating. METHODS: Within a multicenter, first-in-man, single-arm study, 100 patients with symptomatic femoropopliteal disease (Rutherford category 2-4, mean lesion length 5.8 ± 3.9 cm, 35.0% total occlusions) were treated with the NiTiDES stent (Alvimedica). Two-year follow-up included assessment of primary patency (defined as absence of clinically driven target lesion revascularization or binary restenosis with a peak systolic velocity ratio >2.4 by duplex ultrasound), safety, functional, and clinical outcomes. RESULTS: At 24 months, Kaplan-Meier estimates of primary patency and freedom from clinically driven target lesion revascularization were 83.4% (95% CI: 73.9%-89.6%) and 93.1% (95% CI: 85.3%-96.9%), respectively. Over the study period, 3 deaths were reported with no major limb amputation. Functional and clinical benefits were sustained, as 82.1% of patients fell into Rutherford category 0 or 1 at 24 months, which was associated with preserved improvements in all walking disability questionnaire scores. CONCLUSIONS: The 2-year results of the ILLUMINA (Innovative siroLimus seLf expanding drUg-eluting stent for the treatMent of perIpheral disease: evaluation of safety aNd efficAcy) study demonstrate a sustained treatment benefit with a novel sirolimus-eluting stent that also compares favorably to other femoropopliteal intervention trials. Head-to-head comparisons of NiTiDES with a paclitaxel-based DES are warranted. (The ILLUMINA Study [ILLUMINA]; NCT03510676).

Stents With Torsional Strength for Superficial Femoral Artery Disease: The Prospective Q3-Registry.

PURPOSE: This postmarketing surveillance study aimed to assess effectiveness and safety of a peripheral self-expanding stent with high torsional strength (POLARIS stent) for the treatment of de novo superficial femoral artery (SFA) lesions in the routine clinical practice. MATERIALS AND METHODS: Consecutive patients with symptomatic de novo SFA occlusive disease who underwent POLARIS stent implantation were enrolled into the prospective, multicenter, observational postmarket surveillance study. Primary outcome measure was freedom from clinically driven target lesion revascularization (cdTLR) at 12 months. Main secondary outcomes were procedural success, primary clinical improvement, and freedom from major adverse cardiovascular and limb events (MACLE) throughout 24 months. RESULTS: A total of 199 participants (70±11 years, 70.4% men) were included in the study at 9 German sites from December 2014 to August 2018. Half of them (52.6%) were current smokers, 37.6% had diabetes, and 25.0% were obese. Most participants suffered from intermittent claudication (88.4%). Mean lesion length was 98±83 mm, 43.5% of lesions were occluded, and 27.3% were severely calcified. Freedom from 12 months cdTLR was 94.4% (95% confidence interval [CI], 90.6-98.2). At 24 months, freedom from cdTLR was 88.7% (95% CI, 83.0-94.4). Procedural success was achieved in 96.2% of participants. Primary clinical improvement occurred in 87.5% and 85.4% of participants at 12 and 24 months, respectively. Freedom from MACLE was 94.8% (95% CI, 91.4-98.1) and 93.8% (95% CI, 89.9-97.6) at 12 and 24 months, respectively. CONCLUSIONS: Treatment of SFA occlusive disease in a real-world setting using the POLARIS stent with high bidirectional torsional strength is efficacious and does not raise any safety concern in the medium term. The study is registered with ClinicalTrials.gov (Identifier: NCT02307292).

Interventional Treatment of Access Site Complications During Transfemoral TAVI: A Single Center Experience.

Introduction: Transcatheter aortic valve implantation (TAVI) has rapidly developed over the last decade and is nowadays the treatment of choice in the elderly patients irrespective of surgical risk. The outcome of these patients is mainly determined not only by the interventional procedure itself, but also by its complications. Material and Methods: We analyzed the outcome and procedural events of transfemoral TAVI procedures performed per year at our institution. The mean age of these patients is 79.2 years and 49% are female. All the patients underwent duplex ultrasonography of the iliac arteries and inguinal vessels before the procedure and CT of the aorta and iliac arteries. Results: Transfemoral access route is associated with a number of challenges and complications, especially in the patients suffering from peripheral artery disease (PAD). The rate of vascular complications at our center was 2.76% (19/689). Typical vascular complications (VC) include bleeding and pseudoaneurysms at the puncture site, acute or subacute occlusion of the access vessel, and dissection or perforation of the iliac vessels. In addition, there is the need for primary PTA of the access pathway in the presence of additional PAD of the common femoral artery (CFA) and iliac vessels. Balloon angioplasty, implantation of covered and uncovered stents, lithoplasty, and ultrasound-guided thrombin injection are available to treat the described issues. Conclusion: Interventional therapy of access vessels can preoperatively enable the transfemoral approach and successfully treat post-operative VC in most of the cases. Training the heart team to address these issues is a key focus, and an interventional vascular specialist should be part of this team.

Access Site Complications of Peripheral Endovascular Procedures: A Large, Prospective Registry on Predictors and Consequences.

PURPOSE: The purpose of this study was to investigate predictors and consequences of acute vascular access site complications (ASCs) related to peripheral endovascular diagnostic or interventional procedures. Despite improvement of puncture techniques, access site-related morbidity and mortality is still considerable. MATERIALS AND METHODS: A total of 5263 participants who underwent 5385 endovascular procedures at a single center were consecutively included in this prospective, observational study. Primary outcomes were ASCs defined as composite of puncture site hematoma, pseudoaneurysm, arteriovenous fistula, and overt puncture site bleeding on the first day after procedure. RESULTS: ASCs occurred in 16.6% of peripheral endovascular procedures (78.6% hematomas, 18.9% pseudoaneurysms, 1.4% arteriovenous fistulas, 1.1% overt bleedings). Independent predictors were advanced age [odds ratio (OR) per 10 years: 1.12, p=0.004], female sex (OR men, 0.77; p=0.001), lysis (OR 3.56; p<0.001), periprocedural heparin (OR 5000 IU, 1.96; p=0.001; OR >5000 IU, 3.56; p=0.02), time to access (OR per 10 seconds, 1.01; p<0.001), sheath size (OR per French, 1.59; p<0.001), brachial artery access (OR vs retrograde transfemoral, 4.58; p<0.001), and compression only (OR Angio-Seal, 0.57, p=0.02; ProGlide, 0.36, p<0.001; FemoSeal, 0.57, p<0.001). Treatment was required in 20.2% and prolonged hospitalization in 17.7% of ASC. Three participants died from access site-related bleeding. CONCLUSION: ASCs after peripheral endovascular procedures are associated with advanced age, female sex, periprocedural antithrombotic medication, brachial artery access, postinterventional bleeding, and nonuse of vascular closure devices.

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).