Atherectomy Followed by Drug-Coated Balloon Angioplasty Versus Surgery for Symptomatic Deep Femoral Artery Arteriosclerotic Disease.

PURPOSE: Limited data are available regarding endovascular therapy of arteriosclerotic lesions of the deep femoral artery (DFA). In this study, we compare the outcomes of atherectomy combined with drug-coated balloon (DCB) angioplasty and open repair of DFA lesions. METHODS: This is a multicenter retrospective registry of patients with peripheral artery occlusive disease Rutherford categories 2 to 5 treated by surgical profundaplasty (SP) or atherectomy followed by DCB for DFA lesions (symptomatic DFA). The primary endpoint was clinically driven target lesion revascularization (CD-TLR). Overall mortality, target limb reinterventions, major amputation, and major adverse limb events (MALEs) were additionally analyzed. RESULTS: A total of 373 patients treated for an arteriosclerotic lesion of the DFA between February 2015 and August 2021 were included, 301 treated by SP and 72 with atherectomy and DCB. The rates of chronic limb threatening ischemia (CLTI) were 42.2% and 22.2% (p<0.002) for the surgical and endovascular groups, respectively. A previous DFA intervention was more frequent in the endovascular group (30.6% vs 15.3%; p<0.003). Patients who had an open repair were more likely to have an occlusion of the profunda (34.9% vs 19.7%, p=0.014), severe calcified lesions (26.5% vs 5.6%, p=0.001), and lesions longer than 20 mm (95.7% vs 88.7%, p=0.024). After propensity score matching, no significant differences were found with regard to technical and hemodynamic success. At 24 months, no difference was found in terms of freedom from CD-TLR (95.7% vs 96.8%), freedom from all-cause mortality (94.2% vs 98.5%), freedom from MALE (90.4% vs 93.9%), and amputation-free survival (93.8% vs 97%). Following endovascular therapy, length of stay was significantly lower (p<0.001) and any reintervention on the index limb was more frequent (p=0.039). CONCLUSION: Patients with CLTI, occlusion of profunda, severe calcified lesions, and longer lesions are more frequently treated by open surgery, while reinterventions are more commonly treated by atherectomy and DCB. In patients with comparable clinical and lesion characteristics after matching, endovascular and surgical reconstruction of DFA lesions showed similar mid-term clinical outcomes. However, the risk of reintervention at the index limb is higher after endovascular treatment. Randomized studies are now warranted to compare both techniques in terms of medical and financial aspects. CLINICAL IMPACT: Atherectomy followed by DCB of symptomatic DFA is safe and effective. In patients with comparable clinical and lesion characteristics, outcomes are comparable with surgery. However, the risk of reintervention at the index limb is higher after endovascular treatment. Therefore, whenever possible an additional outflow vessel revascularization should be performed by the time of the primary intervention. Randomized studies are warranted to compare endovascular techniques and open surgery also under economic aspects.

Intravascular Lithotripsy and Aortic Bare-Metal Stenting: A Low-Profile Solution for the Treatment of Heavily Calcified Aorto-Iliac Disease.

PURPOSE: To present a novel technique for the treatment of heavily calcified aorto-iliac disease using intravascular lithotripsy (IVL) and self-expanding bare-metal stents (BMS). TECHNIQUE: We present our experience with 4 cases of calcified aorto-iliac disease that were treated with IVL as vessel preparation followed by BMS deployment. Intravascular lithotripsy was performed using a 7-mm or 8-mm Shockwave catheter from 1 access and a non-compliant balloon introduced from the second access in a "hugging-balloon" configuration. Afterward, a self-expandable BMS is deployed in the infrarenal aorta and additional bare-metal balloon-mounted stents are deployed in the iliac arteries as needed. This technique provides a low-profile solution with only 6- and 7-French introducers, preservation of the collateral circulation while also preserving the option for an up-and-over approach in the future. Technical success was achieved in all cases and no periprocedural complications were observed. CONCLUSION: Intravascular lithotripsy in combination with BMS for the infrarenal aorta and the aortic bifurcation seems to be a safe and effective low-profile treatment option for heavily calcified lesions. Large-scale studies with long-term follow-up are needed to validate our positive early results. CLINICAL IMPACT: Endovascular treatment of heavily calcified aortoiliac disease poses significant challenges, including the risk of rupture and dissection. The proposed technique uses intravascular lithotripsy and bare-metal stenting of the aortic bifurcation and represents a low-profile solution that preserves collaterals and potentially reduces the risk of dissection with IVL vessel preparation.

Directional atherectomy with anti-restenotic therapy versus open repair in patients with restenotic disease after surgical revascularization of the common femoral artery.

BACKGROUND: This study evaluated the performance of directional atherectomy with anti-restenotic therapy (DAART) compared to surgery in patients with restenosis of the groin arteries after endarterectomy or femoral bypass anastomosis. METHODS: Consecutive patients with restenotic lesions from two vascular surgery units were retrospectively evaluated. Detailed medical history, type of previous reconstruction, anatomical and perioperative data, 30-day mortality and morbidity as well as data during follow-up were documented. The primary outcome measure was primary patency, whereas technical success, secondary patency, target lesion revascularization (TLR), freedom from major amputation, overall morbidity and mortality were additionally evaluated. RESULTS: The endovascular (25 patients) and surgical (17 patients) groups were comparable regarding the initial surgical reconstruction, demographics, comorbidities and medication. In the DAART group technical success was 100% without any residual stenosis >30%, distal embolization, perforation or bailout stenting. Hospital stay was shorter after DAART (medial 2 vs. 7 days, P<0.001), while more wound complications were documented in the surgical group within the first 30-days (29.4% vs. 0%, P=0.004). Primary patency, secondary patency and TLR were comparable between the groups (66.7% vs. 64.7%, HR 0.95, 95% CI 0.3-2.9, P=0.93, 86.4% vs. 93.8%, HR 0.65, 95% CI 0.65-6.6, P=0.71, 68% vs. 70.6%, HR 0.95, 95% CI 0.3-2.9, P=0.93, respectively). During follow-up no major amputation was observed, the improvement of the Rutherford class was comparable between the two groups and there were two deaths in the surgical group. CONCLUSIONS: In this study, DAART for restenotic atherosclerotic disease of the common femoral artery and its branches is a safe alternative to redo surgery and is associated with shorter hospital stay, fewer wound complications, comparable patency and freedom from TLR rates.

Intravascular Lithotripsy for Treatment of Severely Calcified Common Femoral Artery Disease: Results From the Disrupt PAD III Observational Study.

BACKGROUND: Surgical endarterectomy is currently considered the front-line therapy for the treatment of calcified lesions in the common femoral artery (CFA). Endovascular interventions have evolved, and their use is increasing in frequency. Intravascular lithotripsy (IVL) has shown promising safety and effectiveness in calcified CFA lesions in a small pilot study, but "real-world" evidence from a larger cohort is lacking. METHODS: The Disrupt PAD III Observational Study (NCT02923193) was a prospective, multicenter registry designed to assess the acute safety and effectiveness of IVL treatment for calcified peripheral arterial disease. Any concomitant treatment with other calcium-modifying technologies as well as definitive treatment strategies was at the discretion of the operators. Patients with CFA lesions were evaluated for acute angiographic safety and effectiveness outcomes following IVL treatment as determined by an independent angiographic core lab. RESULTS: Common femoral artery treatment was indicated in 177 patients (n=163 could be analyzed based on core-laboratory data) enrolled at 23 sites. Characteristics for 164 treated lesions included moderate-severe calcification 95.1%, diameter stenosis 74.8±17.7%, and lesion length 53.6±53.1 mm. Concomitant calcium-modifying therapy was used in 32.3% of lesions. Final therapy included drug-coated balloons in 68.9% and stenting in 16.5% of lesions. Post-IVL and final residual stenoses were 29.2±16.5%and 23.6±11.5%, respectively. No vascular complications (flow-limiting dissections, perforations, embolization, slow or no reflow, or abrupt closure) were present at the end of the procedure by core-laboratory assessment, with 1 (0.8%) flow-limiting dissection initially occurring immediately following IVL treatment. CONCLUSION: This study represents the largest real-world experience of IVL treatment in heavily calcified CFA lesions. Intravascular lithotripsy treatment showed significant stenosis reduction and favorable periprocedural safety in this challenging patient population. CLINICAL IMPACT: In this study we show that calcified common femoral artery disease can be safely and effectively treated with shockwave balloon angioplasty with high procedural success and low complication rates and in clinical practice can now be offered as an alternative to surgical treatment in those patients reluctant to or high risk for vascular surgery. This opens another option for clinicians to treat calcified common femoral artery disease without the risk of dissection, perforation or distal embolization that are associated with atherectomy. This study shows that shockwave lithoplasty offers an innovative plaque modification technology to tackle calcified disease in the common femoral artery.

Intravascular lithotripsy-assisted percutaneous deep vein arterialization for no-option chronic limb-threatening patients and heavily calcified tibial occlusive disease.

PURPOSE: To report the first chronic limb-threatening ischemia (CLTI) patients who underwent an intravascular lithotripsy (IVL)-assisted percutaneous deep vein arterialization (pDVA). CASE REPORT 1: An 81-year-old patient presented with CLTI and a heavily calcified lesion of the popliteal artery and tibioperoneal trunk (TPT), with a distal tibial and foot arch occlusion. The patient underwent IVL and drug-coated balloon angioplasty for the distal popliteal artery and of the TPT to improve the inflow prior to pDVA. The wound situation remained stable without secondary procedure until the patient`s deaths due to complications of urosepsis 3 months later. CASE REPORT 2: A 64-year-old patient with rest pain of the left limb with a single-vessel tibial run-off (peroneal artery) and occluded pedal arch was treated with 3.5 mm IVL followed by a successful pDVA as mentioned above. IVL performed in the proximal posterior tibial artery to optimize the inflow to the circuit and change the compliance of the crossing point from the arterial to the vein system. The patient underwent repeat angioplasty of the plantar vein arch 5 months after the index procedure and thereafter remained asymptomatic during 2 years of follow-up. CONCLUSION: The combined use of IVL and pDVA could improve the patency of the reconstruction with clinical benefits in no-option CTLI patients.

Safety and effectiveness of the Phoenix atherectomy device for endovascular treatment of common femoral and popliteal arteries: Results of the EN-MOBILE trial.

Background: This study aimed to assess the peri- and postprocedural outcomes of atherectomy-assisted endovascular treatment of the common femoral (CFA) and popliteal arteries. Methods: Phoenix atherectomy was used for the treatment of 73 and 53 de novo CFA and popliteal artery lesions, respectively, in 122 consecutive patients. Safety endpoints encompassed perforation and peripheral embolization. Postprocedural endpoints included freedom from clinically driven target lesion revascularization (CD-TLR) and clinical success (an improvement of ⩾ 2 Rutherford category [RC]). In addition, 531 patients treated for popliteal artery stenosis or occlusion without atherectomy were used as a comparator group. Results: Procedural success (residual stenosis < 30% after treatment) was 99.2%. The need for bail-out stenting was 2 (2.7%) and 3 (5.7%) in CFA and popliteal artery lesions, respectively. Only one (1.4%) embolization occurred in the CFA, which was treated by catheter aspiration. No perforations occurred. After 1.50 (IQR = 1.17-2.20) years, CD-TLR occurred in seven (9.2%) and six (14.6%) patients with CFA and popliteal artery lesions, respectively, whereas clinical success was achieved in 62 (91.2%) and 31 (75.6%), respectively. Patients treated with atherectomy and DCB in the popliteal artery after matching for baseline RC, lesion calcification, length, and the presence of chronic total occlusion, exhibited higher freedom from CD-TLR compared to the nondebulking group (HR = 3.1; 95% CI = 1.1-8.5, p = 0.03). Conclusion: Atherectomy can be used safely and is associated with low rates of bail-out stenting in CFA and popliteal arteries. CD-TLR and clinical success rates are clinically acceptable. In addition, for the popliteal artery, atherectomy combined with DCB demonstrates lower CD-TLR rates compared to a DCB alone strategy. (German Clinical Trials Register: DRKS00016708).

Impact of Calcification on the Outcomes of Femoropopliteal Artery Endovascular Treatment Using a Polymer Coated Drug-Eluting Stent.

PURPOSE: The aim of this study was to analyze the impact of calcification on the 12 and 24 months outcomes of the Eluvia™ (Boston Scientific®) drug-eluting stent (DES) for femoropopliteal occlusive disease using three different calcium scoring systems. MATERIAL AND METHODS: A single-center, retrospective cohort-study (March-2016 to December-2018) of patients treated with the Eluvia™ DES for femoropopliteal atherosclerosis was performed. Outcomes included primary and secondary patency rates and freedom from target lesion revascularization (FTLR) and were analyzed by comparing the impact of calcium burden according to the following calcium scores: Peripheral Arterial Calcium Scoring System (PACSS) score, number of vessel quadrants affected (0-4) and calcification score per Peripheral Academic Research Consortium (PARC) definitions. RESULTS: In total, 111 Patients were included (mean age: 71.2 ± 7.9; 64% male). Most patients presented with Rutherford class 3 (79.9%), followed by class 5 (12.7%), class 4 (10%) and class 6 (6.4%). The mean lesion length was 197.6 ± 108.5 mm and 74.3% of patients had chronic total occlusions. There were no differences in primary patency between the calcification scores at 12 months (PACSS, LogRank = 0.28; quadrants, LogRank = 0.29; PARC, LogRank = 0.42) and 24 months (PACSS, LogRank = 0.13; quadrants, LogRank = 0.42; PARC, LogRank = 0.13). FTLR was significantly lower at 12 months in patients with calcification affecting 3 or 4 quadrants (LogRank = 0.022) but not at 24 months (LogRank = 0.36). CONCLUSIONS: In this study, the Eluvia™ DES showed promising performance in calcified disease and the analysis according to the quadrant model predicted an increased risk for TLR at 12 months.

Cost Analysis of Target Lesion Revascularisation in Patients With Femoropopliteal In Stent Re-Stenosis or Occlusion: The COSTLY-TLR Study.

OBJECTIVE: To report the cost of target lesion revascularisation procedures (TLR) for femoropopliteal peripheral artery disease (PAD) following stenting, from a healthcare payer's perspective. METHODS: European multicentre study involving consecutive patients requiring femoropopliteal TLR (January 2017 - December 2021). The primary outcome was overall cost (euros) associated with a TLR procedure from presentation to discharge. Exact costs per constituent, clinical characteristics, and early outcomes were reported. RESULTS: This study included 482 TLR procedures (retrospectively, 13 hospitals, six countries): 56% were female, mean age was 75 ± 2 years, 61% were Rutherford class 5 or 6, 67% had Tosaka class 3 disease, and 16% had common femoral or iliac involvement. A total of 52% were hybrid procedures and 6% involved open surgery only. Technical success was 70%, 30 day mortality rate was 1%, and the 30 day major amputation rate was 4%. Most costs were for operating time during the TLR (healthcare professionals' salaries, indirect and estate costs), with a mean of: €21 917 ± €2 110 for all procedures; €23 337 ± €8 920 for open procedures; €12 903 ± €3 108 for endovascular procedures; and €22 806 ± €3 977 for hybrid procedures. In a regression analysis, procedure duration was the main parameter associated with higher overall TLR costs (coefficient, 2.77; standard error, 0.88; p < .001). The mean cost per operating minute of TLR (indirect, estate costs, all salaried staff present included) was €177 and the mean cost per night stay in hospital (outside intensive care unit) was €356. The mean cost per overnight intensive care unit stay (minimum of 8 hours per night) was €1 193. CONCLUSION: The main driver of the considerable peri-procedure costs associated with femoropopliteal TLR was procedure time.

Burden of Stroke in Europe: An Analysis of the Global Burden of Disease Study Findings From 2010 to 2019.

BACKGROUND: While most European Regions perform well in global comparisons, large discrepancies within stroke epidemiological parameters exist across Europe. The objective of this analysis was to evaluate the stroke burden across European regions and countries in 2019 and its difference to 2010. METHODS: The GBD 2019 analytical tools were used to evaluate regional and country-specific estimates of incidence, prevalence, deaths, and disability-adjusted life years of stroke for the European Region as defined by the World Health Organization, with its 53 member countries (EU-53) and for European Union as defined in 2019, with its 28 member countries (EU-28), between 2010 and 2019. Results were analyzed at a regional, subregional, and country level. RESULTS: In EU-53, the absolute number of incident and prevalent strokes increased by 2% (uncertainty interval [UI], 0%-4%), from 1 767 280 to 1 802 559 new cases, and by 4% (UI, 3%-5%) between 2010 and 2019, respectively. In EU-28, the absolute number of prevalent strokes and stroke-related deaths increased by 4% (UI, 2%-5%) and by 6% (UI, 1%-10%), respectively. All-stroke age-standardized mortality rates, however, decreased by 18% (UI, -22% to -14%), from 82 to 67 per 100 000 people in the EU-53, and by 15% (UI, -18% to -11%), from 49.3 to 42.0 per 100 000 people in EU-28. Despite most countries presenting reductions in age-adjusted incidence, prevalence, mortality, and disability-adjusted life year rates, these rates remained 1.4×, 1.2×, 1.6×, and 1.7× higher in EU-53 in comparison to the EU-28. CONCLUSIONS: EU-53 showed a 2% increase in incident strokes, while they remained stable in EU-28. Age-standardized rates were consistently lower for all-stroke burden parameters in EU-28 in comparison to EU-53, and huge discrepancies in incidence, prevalence, mortality, and disability-adjusted life-year rates were observed between individual countries.

Treatment of Femoropopliteal Artery Disease with Polymer-Coated Drug-Eluting Stent: 5-Year Results of a Prospective, Non-Randomized Study Including the Halo Phenomenon.

PURPOSE: To investigate the long-term results of the Eluvia drug-eluting stent (DES) implantation for femoropopliteal arterial disease, including the 'halo' phenomenon. Long-term data of DES is scarce. A focal reaction ('halo') following Eluvia DES deployment has been described. However, the long-term clinical impact of this phenomenon remains unclear. METHODS: This prospective, non-randomized, single-arm study included 130 consecutive patients treated with an Eluvia DES for symptomatic femoropopliteal disease between March 2016 and December 2018. Clinical outcomes and imaging were assessed after 6 months and annually thereafter for up to 5 years. The primary outcome measure was primary patency. Secondary outcomes were freedom from clinically driven target lesion revascularization (CD-TLR), freedom from major amputation, overall survival and amputation-free survival rates. RESULTS: The primary patency was 65% at 5 years. The freedom from CD-TLR and from major amputation at 5 years was 79 and 96%, respectively. The overall survival and amputation-free survival rates were 88 and 83% at 60 months, respectively. Out of the 27 patients with a halo sign, two showed an increased (7.4%) and 6 (22.2%) a decreased diameter. In 19 cases (70.4%), the diameter remained unchanged at the latest follow-up. The presence of the 'halo' sign was associated with increased primary patency (87% versus 59%, HR: 2.48, 95%CI 1.19-5.16, P = .015). CONCLUSIONS: The presented patient cohort treated with the Eluvia DES for femoropopliteal artery lesions indicates durable efficacy and a good safety profile regardless of the halo phenomenon. The results need to be confirmed in a larger patient cohort. LEVEL OF EVIDENCE III: Non-randomized controlled cohort/follow-up study.

Cost-effectiveness analysis of intravascular ultrasound-guided peripheral vascular interventions in patients with femoropopliteal peripheral artery disease.

Background: Intravascular ultrasound (IVUS)-guided percutaneous transluminal angioplasty (PTA) might offer clinical benefits compared to angiography-guided PTA in patients with peripheral artery disease (PAD). A cost-effectiveness model was developed to examine the benefits and costs of IVUS-guided PTA versus angiography-guided PTA in PAD patients with femoropopliteal (FP) occlusive disease. Methods: A two-step model (a one-year decision tree followed by a lifetime semi-Markov model) was developed from a German healthcare payer perspective to estimate the costs and outcomes over a one-year and lifetime horizon. Clinical events included target lesion revascularization (TLR), amputation, and death. Transition probabilities and utility values were derived from published literature. Healthcare costs were based on German Diagnosis Related Groups (DRG) codes. Costs and outcomes were discounted at a rate of 3% per year. The incremental cost-effectiveness ratio (ICER) was calculated, and sensitivity analyses were performed to assess the robustness of the results. Results: In the one-year horizon, IVUS-guided PTA resulted in incremental quality-adjusted life-years (QALY) and costs of 0.02 and €919 per patient respectively, with a corresponding ICER of €45,195/QALY gained versus angiography-guided PTA. In the lifetime horizon, IVUS-guided PTA outperforms angiography-guided PTA; it was associated with a cost saving of €46 per patient and incremental QALY of 0.22. Utility value for post-TLR, as well as probabilities of death and TLR had the greatest impact on the one-year ICER, while cost of TLR and probabilities of TLR and amputation influenced the lifetime ICER most. The probability of IVUS-guided PTA being cost-effective at a willingness-to-pay (WTP) threshold of €50,000/QALY was 50.4% in the one-year horizon and increased to 85.9% in the lifetime horizon. Conclusions: In this analysis IVUS-guided PTA among patients with symptomatic FP atherosclerosis was cost-saving in a lifetime horizon from the German healthcare payer perspective.

Outcomes of Using Balloon-Expandable Covered Stent for Percutaneous Treatment of Access-Site Vascular Injury after Transfemoral Aortic Valve Implantation: A Single Center Experience.

BACKGROUND: Access-site vascular injury (ASVI) remains a challenge for transfemoral transcatheter aortic valve implantation (TAVI). Although surgery is the gold standard, endovascular therapy gains growing acceptance as primary treatment option for ASVI. The aim of this study was to analyze the safety and efficacy of covered balloon-expandable stents (BXSs) placement for ASVI after transfemoral TAVI. METHODS: All patients treated with a covered BXS between January 2018 and December 2020 for access-site related bleeding complications following femoral TAVI were included in this single center retrospective study. Primary measure outcome of this study was the primary patency at 12 months. Technical success, limb clinical worsening and device related complications were additionally analyzed. RESULTS: During the study period, 576 percutaneous femoral TAVIs were performed. Of these, 36 patients (6%) underwent covered stent deployment for a femoral access-site complication (19 men, median age 83 years old). Procedural success was 97%. The median follow-up was 12 months (interquartile range [IQR] = 9.7, range 0-36 months). One patient was lost to follow-up. The primary patency rates at 6 and 12 months were 100% and 95% respectively. No clinical deterioration or stent fracture was described during this period. CONCLUSIONS: Our results suggest that covered BXS deployment is a safe and effective alternative to surgery and may be a promising option for treating ASVI after femoral TAVI.

Outcomes After Open Surgical, Hybrid, and Endovascular Revascularization for Acute Limb Ischemia.

PURPOSE: To report the performance of surgical treatment (ST), hybrid treatment (HT), and endovascular treatment (ET) for patients with acute limb ischemia (ALI). METHODS: This is a retrospective, comparative study of all consecutive patients with ALI treated in 2 tertiary centers between April 2010 and April 2020. Amputation and/or death (amputation-free survival; AFS) was the primary composite endpoint. Mortality, major amputation, and reintervention during follow-up were additionally analyzed. Proportional hazards modeling was used to identify confounders, results are presented as hazard ratio (HR) and 95% confidence intervals (CIs). RESULTS: In total, 395 patients (mean age=71.1±13.6 years; 51.1% female) were treated during the study period. Surgical treatment was preferred in 150 patients (38%), while 98 were treated by HT (24.8%) and 147 by ET (37.2%). Rutherford class IIa was the most common clinical presentation in the ET group (50.3%), whereas Rutherford IIb was most common in the ST (54%) and HT (48%) groups (p<0.001). Significantly, more patients presented with a de novo lesion in the ST and HT groups (79.3% and 64.3%, respectively) compared with ET (53.7%; p<0.001). Median follow-up was 20 months (range=0-111 months). In the multivariate analysis, ET showed significantly better AFS during follow-up compared with ST (HR=1.89, 95% CI=1.2-2.9, p<0.001) and HT (HR=1.73, 95% CI=1.1-3.1, p<0.001). Mortality during follow-up was also significantly lower after ET compared with ST (HR=2.21, 95% CI=1.31-3.74, p=0.003) and HT (HR=2.04, 95% CI=1.17-3.56, p=0.012). Endovascular treatment was associated with lower amputation rate compared with ST (HR=2.27, 95% CI=1.19-4.35, p=0.013) but was comparable with HT (HR=2.00, 95% CI=0.98-4.06, p=0.055). Reintervention rates did not differ significantly between the groups (ET vs ST: HR=1.52, 95% CI=0.99-2.31, p=0.053; ET vs HT: HR=1.3, 95% CI=0.81-2.07, p=0.27). CONCLUSION: Endovascular treatment for ALI was associated with improved AFS and comparable reintervention rates compared with open surgical and hybrid therapy. CLINICAL IMPACT: Treatment of acute lower limb ischemia remains a challenge for clinicians with high morbidity and mortality rates. Endovascular revascularization is considered first line treatment for many and hybrid treatments are becoming more common, however data is limited to either old trials, small series or with short follow-up. We present herein our 10-year experience with all available devices and techniques for open surgical, endovascular and hybrid acute limb ischemia treatments and compare their outcomes.

Three-Year Safety and Efficacy of the INCRAFT Endograft for Treatment of Abdominal Aortic Aneurysms: Results of the INSIGHT Study.

PURPOSE: Preliminary results of the INSIGHT study showed that the low-profile INCRAFT Abdominal Aortic Aneurysm (AAA) Stent-Graft System was safe and effective in the endovascular aneurysm repair (EVAR). This study aimed to assess the durability and the midterm effectiveness of EVAR using the INCRAFT System in the framework of a multicenter, prospective, open-label, post-approval study. MATERIALS AND METHODS: Between 2015 and 2016, 150 subjects from 23 European centers treated with the INCRAFT System for an infrarenal AAA were included. Clinical and radiologic data were prospectively collected and analyzed using protocol-specified, monitored follow-up clinic visits at 1, 6, and 12 months post-implantation and annually after that. The clinical success at 3 years was determined. Freedom from overall and aneurysm-related mortality, type I endoleak, secondary interventions, and aneurysm sac enlargement through 3 years were evaluated. Kaplan-Meier estimates were used for late outcomes. An independent clinical events committee reviewed all events. The CT (computed tomography) scans through 1 year were reviewed by an independent core laboratory. RESULTS: The primary clinical success rate at 3 years was 84.0% (126/150). There were no aneurysm-related deaths, endograft migration, or aneurysm-related ruptures through 3 years. Stent fracture was detected in 2 subjects (1.3%) without clinical sequelae. Over 3 years, freedom from overall mortality was 89.4%, freedom from secondary interventions was 80%, and freedom from aneurysm sac enlargement was 96.5%. The 3-year freedom from type IA and IB endoleaks was 93.3% and 98.6%, respectively. CONCLUSIONS.: In a multicenter real-world study setting, the use of a low-profile INCRAFT device for AAA is associated with sustained clinical success and low rates of reinterventions through 3 years. CLINICAL IMPACT: Low-profile endografts have broadened the spectrum of patients with anatomic suitability for endovascular repair of abdominal aortic aneurysms (AAA). However, questions remain regarding the durability of the repair. The INSIGHT study evaluated the use of the INCRAFT System in routine real-world clinical practice, including patients with complex anatomies. The treatment was safe and effective. The results showed sustained clinical success over 3 years, with no aneurysm-related deaths or ruptures, and a high rate of intervention-free survival at 3 years. Despite the low-profile design of the endograft, the midterm results demonstrate the durability of AAA repair using the INCRAFT System.ClinicalTrials.gov Identifier: NCT02477111.

Endovascular Versus Surgical Treatment for All Comer Patients With Prosthetic Bypass Graft Occlusion: The Multicentre ENSUPRO Study.

OBJECTIVE: Bypass surgery plays a key role in complex lower limb lesions. However, there is a lack of evidence regarding the management of symptomatic prosthetic bypass graft (PBG) occlusion. This study aimed to report outcomes following open, hybrid, or endovascular management of patients presenting with symptomatic PBG occlusion. METHODS: A multicentre, retrospective cohort study was conducted, including patients presenting with PBG occlusion between January 2014 and December 2021 from 18 centres. It assessed the comparative value of treatment strategies, including (1) recanalisation of native vessels, (2) endovascular treatment of the failed PBG, (3) hybrid treatment, and (4) open surgery. The primary outcome measure was amputation free survival (AFS, time to major amputation and or death), whereas all cause mortality, major amputation, PBG re-occlusion, target lesion revascularisation (TLR), and Rutherford category (RC) improvement during follow up were considered as secondary endpoints. RESULTS: Of 260 patients with occluded PBGs, 108 (41.5%) were treated endovascularly (24 [22.2%] by recanalisation of native vessels and 84 [77.7%] by PBG re-opening), 57 (21.9%) underwent hybrid revascularisation, and 58 (22.3%) had surgery. In addition, 27 (10.4%) were treated conservatively and 10 (3.8%) received systemic thrombolysis. With a median follow up of 1.4 (0.6 - 3.0) years, AFS was 95.5%, 76.4%, 45.5%, and 37.1%, respectively in Groups 1 - 4 (p = .007). Older age and non-endovascular treatment (HR 1.05 and 1.70; p < .01 for both) were independent predictors of poor AFS. Endovascular treatment was associated with lower rates of major amputation (p = .04), PBG re-occlusion (p < .001), and TLR (p = .037), and higher RC improvements (p < .001), whereas all cause mortality was comparable between treatment groups (p = .21). CONCLUSION: Endovascular treatment is associated with higher rates of AFS and RC improvement and lower rates of PBG re-occlusion and TLR in patients with PBG occlusion.

Editor's Choice - RANDOMisation Screening for Drug coated or Drug Eluting Device Randomised Trials Among Patients Undergoing Endovascular FemorOPopliteal Procedures (RANDOM-STOP study).

OBJECTIVE: The aim was to assess the proportion of patients undergoing endovascular therapy for femoropopliteal arterial disease (FP) who would be eligible to take part in seven major randomised controlled trials (RCTs) that investigated the efficacy of some of the currently available paclitaxel based (PTX) devices used in this clinical context. Various RCTs have shown a potential clinical benefit from the use of paclitaxel in FP endovascular therapy. Nonetheless, patients enrolled were highly selected and the generalisability of these findings in pragmatic cohorts is unclear. METHODS: Between 1 January and 31 December 2021, all consecutive patients who underwent endovascular procedures for symptomatic FP disease in 16 European centres were retrospectively screened and included in this analysis. The primary outcome measure was individual patient eligibility for inclusion into at least one of the seven RCTs. The reasons for exclusion (clinical and or radiological) as well as in hospital death and morbidity were also reported. RESULTS: A total of 1 567 consecutive patients (959 male, 61%), corresponding to 1 567 lower limbs, were included. Most patients (1 009 patients, 64.39%) were treated for chronic limb threatening ischaemia (CLTI). A total 1 280 patients (81.68%) were not eligible for inclusion in any of the evaluated RCTs. Of them, 741 (47.28%) were excluded for clinical and 1 125 (71.79%) for radiological reasons. CONCLUSION: The analysed RCTs assessing the efficacy or effectiveness of PTX based endovascular therapies do not seem representative of the patient population with FP disease receiving endovascular therapy in routine clinical practice.

[Malperfusion after Aortic Dissection - Management and Techniques]. / Malperfusion nach Aortendissektion - Management und Techniken.

Malperfusion is a common complication of aortic dissection and further increases this deadly disease's mortality. An effective treatment strategy requires a timely diagnosis based on the clinical findings and the available instruments, understanding the disease's pathomechanism, recognising the therapy options recommended by the guidelines, and the diagnostic and therapeutic innovations of the area of research. The final treatment decision should be patient- and case-specific. In this work, we have considered malperfusion after aortic dissection, not only as a complication of aortic dissection but as a separate disease and summarise important information that can contribute to efficient therapy decisions in everyday clinical practice.

Facilitators and Barriers to Implementation of Simulation Based Education in Vascular Surgery in Europe.

OBJECTIVE: This study explored the status and availability of simulation based education (SBE) for learning vascular surgical procedures identified in the 2019 General Needs Assessment in vascular surgery in Europe (GNA-2019) and identified facilitators and barriers to SBE implementation in vascular surgery. METHODS: A three round iterative survey was distributed via the European Society for Vascular Surgery and the Union Européenne des Médecins Spécialistes. Members from leading committees and organisations within the European vascular surgical community were invited to participate as key opinion leaders (KOLs). Three online survey rounds explored demographics, SBE availability, and facilitators and barriers to SBE implementation. RESULTS: Overall, 147 KOLs (target population 338) accepted invitation to round 1, representing 30 European countries. The dropout rates for rounds 2 and 3 were 29% and 40%, respectively. Most respondents (88%) were senior, consultant level or higher. No mandatory SBE training was required in their department before training on patients, according to 84% of the KOLs. There was high consensus on the need for structured SBE (87%) and mandatory SBE (81%). SBE is available for the top three prioritised procedures in GNA-2019 (basic open skills, basic endovascular skills, and vascular imaging interpretation) in 24, 23, and 20 of the 30 represented European countries, respectively. The highest ranking facilitators were structured SBE programmes, availability of simulation equipment locally and regionally, good quality simulators, and having a dedicated person running the SBE. The highest ranked barriers were lack of structured SBE curriculum, equipment costs, lack of SBE culture, no or limited dedicated time for faculty to teach in SBE, and clinical work overload. CONCLUSION: Based largely on the opinions of KOLs in vascular surgery in Europe, this study revealed that SBE is needed in vascular surgery training and that systematic and structured programmes are required to ensure successful implementation.

Hybrid and open repair for patients with acute limb ischemia of the lower extremities.

BACKGROUND: Hybrid revascularization procedures for acute limb ischemia (ALI) are becoming increasingly common, bibliographic data on outcomes is however sparse. METHODS: Single-center, retrospective study of consecutive patients with ALI that underwent either surgical treatment (ST) or hybrid treatment (HT) between January 2015 and December 2021. The composite outcome of amputation-free survival (AFS) was the primary endpoint. Technical success, overall survival, amputation, and re-intervention rates were the secondary endpoints. RESULTS: During the study period 266 patients (mean age 70.2±14.5 years; 49.6% males) were treated for ALI, 67.3% undergoing ST and 32.7% HT. HT was more frequently used in patients with a previous vascular intervention in the index limb (38/87; 43.7% HT vs. 40/179; 22.3% ST, P=0.001), a stent- or stent graft-occlusion (16/87; 18.4% HT vs. 10/179; 5.6% ST, P=0.002) and/or a bypass occlusion (16/87; 18.4% HT vs. 16/179; 8.9% ST, P=0.043). Technical success was higher in the OR group (75/87; 86.2% HT vs. 173/179; 96.6% ST, P=0.003). Amputation-free survival rate during follow-up (43/87; 49.4% HT vs. 94/179; 52.5% ST, HR 0.76, 95% CI: 0.49 to 1.18, P=0.22) and overall survival (32/87; 36.8% HT vs. 84/179; 46.9% ST, HR 0.81, 95% CI: 0.49 to 1.34, P=0.41) were comparable between the two groups. No statistical differences were observed between the groups regarding major amputation (19/87; 21.8% HT vs. 15/179; 8.4% ST, HR 0.85, 95% CI: 0.33 to 2.23, P=0.74) or reintervention during follow-up (45/87; 51.7% HT vs. 65/179; 36.3% ST, HR 0.92, 95% CI: 0.56 to 1.51, P=0.73). CONCLUSIONS: Hybrid and open surgical treatments showed comparable results in our cohort, even though significantly more patients undergoing HT presented with stent and bypass occlusions rather than de-novo lesions.

Acute Kidney Injury Following Revascularization in Patients With Chronic Limb-Threatening Ischemia and Non-Dialysis-Dependent Chronic Kidney Disease: Insights From the NSQIP Database at 30-Day Follow-Up.

BACKGROUND: Patients with chronic limb-threatening ischemia (CLTI) and chronic kidney disease (CKD) are at risk of developing renal injury following revascularization. We aimed to compare the risk of adverse renal events following endovascular revascularization (ER) or open surgery (OS) in patients with CLTI and CKD. METHODS: A retrospective analysis of the National Surgical Quality Improvement Program (NSQIP) databases (2011-2017) was performed including patients with CLTI and non-dialysis-dependent CKD, comparing ER to OS. The primary outcome was a composite of postprocedural kidney injury or failure within 30 days. Thirty-day mortality, major adverse cardiac and cerebrovascular events (MACCE), amputation, readmission or target lesion revascularization (TLR) were compared using multivariate logistic regression and propensity-score matched analysis. RESULTS: A total of 5009 patients were included (ER: 2361; OS: 3409). The risk for the composite primary outcome was comparable between groups (odds ratio [OR]: 0.78, 95% confidence interval (CI): 0.53-1.17) as for kidney injury (n=54, OR: 0.97, 95% CI: 0.39-1.19) or failure (n=55, OR: 0.68, 95% CI: 0.39-1.19). In the adjusted regression, a significant benefit was observed with ER for the primary outcome (OR: 0.60, p=0.018) and renal failure (OR: 0.50, p=0.025), but not for renal injury (OR: 0.76, p=0.34). Lower rates of MACCE, TLR, and readmissions were observed after ER. Thirty-day mortality and major amputation rates did not differ. In the propensity score analysis, revascularization strategy was not associated with renal injury or failure. CONCLUSIONS: In this cohort, the incidence of renal events within 30 days of revascularization in CLTI was low and comparable between ER and OR. CLINICAL IMPACT: In a cohort of 5009 patients with chronic limb-threatening ischemia and non-end-stage chronic kidney disease (CKD), postprocedural kidney injury or failure within 30 days was comparable between patients submitted to open or endovascular revascularization (ER). Lower rates of major adverse cardiac and cerebrovascular events, target lesion revascularization, and readmissions were observed after endovascular revascularization. Based on these findings, ER should not be avoided due to fear of worsening renal function in CKD patients with chronic limb-threatening ischemia. In fact, these patients benefit more from ER regarding cardiovascular outcomes with no increased risk of kidney injury.