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1.
JACC Cardiovasc Interv ; 17(9): 1134-1144, 2024 May 13.
Article En | MEDLINE | ID: mdl-38749594

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).


Cardiovascular Agents , Coated Materials, Biocompatible , Drug-Eluting Stents , Femoral Artery , Peripheral Arterial Disease , Popliteal Artery , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , Angioplasty, Balloon/instrumentation , Angioplasty, Balloon/adverse effects , Cardiovascular Agents/administration & dosage , Cardiovascular Agents/adverse effects , Femoral Artery/diagnostic imaging , Femoral Artery/physiopathology , Paclitaxel/administration & dosage , Peripheral Arterial Disease/therapy , Peripheral Arterial Disease/diagnostic imaging , Peripheral Arterial Disease/physiopathology , Pilot Projects , Popliteal Artery/diagnostic imaging , Popliteal Artery/physiopathology , Prospective Studies , Prosthesis Design , Risk Factors , Time Factors , Treatment Outcome , Vascular Access Devices , Vascular Patency
2.
JTCVS Open ; 18: 1-8, 2024 Apr.
Article En | MEDLINE | ID: mdl-38690411

Objective: Minimally invasive segmental artery coil embolization was introduced to prevent spinal cord ischemia after endovascular repair of thoracoabdominal aortic aneurysms. There is no consensus on whether the endovascular occlusion of segmental arteries feeding directly the anterior radiculomedullary artery and anterior spinal artery can be safely performed without causing spinal cord ischemia. Our aim was to investigate the feasibility and clinical impact of endovascular occlusion of segmental arteries supplying the anterior spinal artery during minimally invasive segmental artery coil embolization in patients with thoracoabdominal aortic aneurysms. Methods: Between January 2018 and July 2020, 54 patients (36 male; mean age, 71.1 ± 9.3 years) underwent direct embolization of segmental arteries feeding the anterior radiculomedullary artery before endovascular repair of thoracoabdominal aortic aneurysms. End points included technical success of minimally invasive segmental artery coil embolization of segmental arteries, anterior radiculomedullary artery, neurological complications, and in-hospital mortality after minimally invasive segmental artery coil embolization and endovascular repair of thoracoabdominal aortic aneurysms. Results: The thoracoabdominal aortic aneurysm classification was type I (n = 8), type II (n = 24), type III (n = 11), and type IV (n = 11). During minimally invasive segmental artery coil embolization, 388 segmental arteries were occluded, each patient having 7.2 ± 3.1 coiled segmental arteries occluding 64.5% (25-100%) of open segmental arteries within the treated aortic segment. Altogether, 66 anterior radiculomedullary arteries were seen originating between Th8 and L3 levels from 85 (21.9%) segmental arteries. In 10 patients (18.5%), 2 large anterior radiculomedullary arteries were identified, and 1 patient (1.9%) showed 3 anterior radiculomedullary arteries on the spinal arteriography. No spinal cord ischemia or procedure-related complications occurred after minimally invasive segmental artery coil embolization. After 47.9 ± 39.4 days, all patients received endovascular repair of their thoracoabdominal aortic aneurysms. There was no in-hospital mortality. One male patient developed incomplete temporary spinal cord ischemia after endovascular repair. Conclusions: Minimally invasive segmental artery coil embolization of segmental arteries feeding the anterior spinal artery in patients with thoracoabdominal aortic aneurysms to prevent spinal cord ischemia after endovascular repair is feasible and clinically safe.

3.
CVIR Endovasc ; 7(1): 42, 2024 May 03.
Article En | MEDLINE | ID: mdl-38700601

BACKGROUND: Preemptive selective embolization of aneurysm sac side branches (ASSBs) has been proposed to prevent type II endoleak after endovascular aortic aneurysm repair (EVAR). This study aimed to explore if an embolization strategy using microvascular plugs (MVP) reduces intervention time and radiation dose compared to platinum-fibered microcoils. Furthermore, the effectiveness of the devices in occluding the treated artery was assessed. METHODS: Sixty patients scheduled for EVAR underwent percutaneous preemptive embolization of ASSBs using MVPs or coils after a 1:1 randomization. Follow-up imaging was performed during aortic stentgraft implantation. RESULTS: Overall, 170 ASSBs were successfully occluded (83 arteries by MVPs and 87 by coils) and no acute treatment failure occurred. The mean procedure time was significantly lower in the group treated with MVPs (55 ± 4 min) compared to coil occlusion (67 ± 3 min; p = 0.018), which was paralleled by a numerically lower radiation dose (119 Gy/cm2 vs. 140 Gy/cm2; p = 0.45). No difference was found for contrast agent use (34 ml MVP group vs 35 ml coil group; p = 0.87). At follow-up, reopening of lumbar arteries was seen in nine cases (four after coil embolization; five after MVPs). CONCLUSION: Both microvascular plugs and coils can be effectively used for preemptive embolization of aneurysm sac side branches before EVAR. Use of plugs offers a benefit in terms of intervention time. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03842930 Registered 15 February 2019.

4.
J Clin Med ; 12(15)2023 Aug 06.
Article En | MEDLINE | ID: mdl-37568548

Within this single-center cohort study, we investigated the impact of optimal medical therapy on all-cause mortality, major amputation-free survival and clinically driven target lesion revascularization (CD TLR) in 552 patients with peripheral arterial disease (PAD) undergoing endovascular infrapopliteal revascularization. From the overall cohort, 145 patients were treated for intermittent claudication (IC) and 407 were treated for critical limb ischemia (CLI). Optimal medical therapy (OMT) was defined as the presence of at least one antiplatelet agent, statin and ACE inhibitor or AT-2 antagonist based on guideline recommendations. About half (55.5%) of all patients were prescribed OMT at discharge, with a higher proportion in claudicants (62.1%) versus CLI patients (53.2%). Over three years of follow-up, survival was significantly better in patients with IC (80.6 ± 3.8% vs. 59.9 ± 2.9%; p < 0.001). There was a signal towards better survival in those patients receiving OMT (log-rank p = 0.09). Similarly, amputation-free survival (AFS) was significantly better in patients with IC (p = 0.004) and also in patients receiving OMT (78.8 ± 3.6%) compared to that in those without OMT (71.5 ± 4.2%; p = 0.046). Freedom from CD TLR within three years was significantly better in the IC group (p = 0.002), but there were no statistically significant differences for CD TLR dependent on the presence of OMT (p = 0.79). In conclusion, there is still an important underuse of OMT in patients undergoing infrapopliteal interventions, which is even more pronounced in CLI despite a signal for its benefit regarding all-cause mortality and major amputation-free survival.

5.
Obes Surg ; 33(8): 2375-2383, 2023 08.
Article En | MEDLINE | ID: mdl-37392352

BACKGROUND: Due to Covid-19, elective medical procedures were partly postponed to reduce the burden on the medical system. The impact of these effects in bariatric surgery and their individual consequences remain unknown. MATERIALS/METHODS: In a retrospective monocentric analysis, all bariatric patients at our centre between 01/2020 and 12/2021 were investigated. All patients with postponed surgery due to pandemic were analysed regarding weight change and metabolic parameters. In addition, we performed a nationwide cohort study of all bariatric patients in 2020 using billing data provided by the Federal Statistical Office. Population adjusted procedure rates of 2020 were compared to 2018/2019. RESULTS: Seventy-four patients (42.5%) out of 174 scheduled for bariatric surgery were postponed due to pandemic-related limitations, and 47 (63.5%) patients waited longer than 3 months. Mean postponement was 147.7 days. Apart from outliers (6.8% of all patients), mean weight (+0.9 kg) and body mass index (+0.3 kg/m2) remained stable. HbA1c increased significantly in patients with a postponement longer than 6 months (p = 0.024) and in diabetic patients (+0.18% vs -0.11 in non-diabetic, p = 0.042). In the Germany-wide cohort, the overall reduction of bariatric procedures in the first lockdown (04-06/2020) was -13.4% (p = 0.589). In the second lockdown (10-12/2020), there was no nationwide detectable reduction (+3.5%, p = 0.843) but inter-state differences. There was a catch-up in the interim months (+24.9%, p = 0.002). CONCLUSION: For future lockdowns or other healthcare bottleneck circumstances, the impact of postponement in bariatric patients has to be addressed and prioritization of vulnerable patients (e.g. diabetics) should be considered.


Bariatric Surgery , COVID-19 , Obesity, Morbid , Humans , Obesity, Morbid/surgery , COVID-19/epidemiology , Cohort Studies , Retrospective Studies , Communicable Disease Control , Germany/epidemiology
6.
J Clin Med ; 12(5)2023 Mar 01.
Article En | MEDLINE | ID: mdl-36902745

We aimed to review the feasibility and safe use of the percutaneous axillary artery (AxA, 100 patients) approach for endovascular repair (ER) of thoraco-abdominal aortic aneurysms (TAAA, 90 patients) using fenestrated, branched, and chimney stent grafts and other complex endovascular procedures (10 patients) necessitating AxA access. Percutaneous puncture of the AxA in its third segment was performed using sheaths sized between 6 to 14F. For closing puncture sites greater than 8F, two Perclose ProGlide percutaneous vascular closure devices (PVCDs) (Abbott Vascular, Santa Clara, CA, USA) were deployed in the pre-close technique. The median maximum diameter of the AxA in the third segment was 7.27 mm (range 4.50-10.80). Device success, defined as successful hemostasis by PVCD, was reported in 92 patients (92.0%). As recently reported results in the first 40 patients suggested that adverse events, including vessel stenosis or occlusion, occurred only in cases with a diameter of the AxA < 5 mm, in all subsequent 60 cases AxA access was restricted to a vessel diameter ≥ 5 mm. In this late group, no hemodynamic impairment of the AxA occurred except in six early cases below this diameter threshold, all of which could be repaired by endovascular measures. Overall mortality at 30 days was 8%. In conclusion, percutaneous approach of the AxA in its third segment is feasible and represents a safe alternative access to open access for complex endovascular aorto-iliac procedures. Complications are rare, especially if the maximum diameter of the access vessel (AxA) is ≥5 mm.

7.
Dtsch Med Wochenschr ; 148(6): 282-287, 2023 03.
Article De | MEDLINE | ID: mdl-36878225

Acute limb ischemia is a vascular emergency and current guidelines emphasize the need for rapid treatment in a vascular center with an option of open surgical and interventional revascularization. Endovascular revascularization options for acute limb ischemia are increasingly focused on a wide range of mechanical thrombectomy devices based on different operating principles.For patients with acute limb ischemia in the setting of covid-19 infection high mortality rates and low technical success rates of revascularization procedures have been described.


COVID-19 , Humans , Thrombectomy , Ischemia/diagnosis , Ischemia/therapy
8.
Int J Mol Sci ; 24(4)2023 Feb 16.
Article En | MEDLINE | ID: mdl-36835370

Clonal hematopoiesis (CH)-associated mutations increase the risk of atherosclerotic cardiovascular diseases. However, it is unclear whether the mutations detected in circulating blood cells can also be detected in tissues associated with atherosclerosis, where they could affect physiology locally. To address this, the presence of CH mutations in peripheral blood, atherosclerotic lesions and associated tissues was assessed in a pilot study of 31 consecutive patients with peripheral vascular disease (PAD) who underwent open surgical procedures. Next-generation sequencing was used to screen the most commonly mutated loci (DNMT3A, TET2, ASXL1 and JAK2). Twenty CH mutations were detected in peripheral blood of 14 (45%) patients, 5 of whom had more than one mutation. TET2 (11 mutations, 55%) and DNMT3A (8 mutations, 40%) were the most frequently affected genes. Altogether, 88% of the mutations detectable in peripheral blood were also present in the atherosclerotic lesions. Twelve patients also had mutations in perivascular fat or subcutaneous tissue. The presence of CH mutations in PAD-associated tissues as well as in blood suggests that CH mutations may make a previously unknown contribution to PAD disease biology.


Clonal Hematopoiesis , Peripheral Arterial Disease , Humans , Clonal Hematopoiesis/genetics , Mutation , Peripheral Arterial Disease/genetics , Pilot Projects
9.
J Clin Med ; 11(23)2022 Dec 04.
Article En | MEDLINE | ID: mdl-36498777

The aim of this systematic review was to summarise the comparative evidence on the risk of contrast-associated acute kidney injury (CA-AKI) with CO2 or iodinated contrast medium (ICM) for peripheral vascular interventions. We searched Ovid MEDLINE, Cochrane Library, Embase, Epistemonikos, PubMed-similar-articles, clinical trial registries, journal websites, and reference lists up to February 2022. We included studies comparing the risk of CA-AKI in patients who received CO2 or ICM for peripheral angiography with or without endovascular intervention. Two reviewers screened the references and assessed the risk of bias of the included studies. We extracted data on study population, interventions and outcomes. For the risk of CA-AKI as our primary outcome of interest, we calculated risk ratios (RRs) with a 95% confidence interval (CI) and performed random-effects meta-analyses. We identified three RCTs and five cohort studies that fully met our eligibility criteria. Based on a random-effects meta-analysis, the risk of CA-AKI was lower with CO2 compared to ICM (8.6% vs. 15.2%; RR, 0.59; 95% CI 0.33-1.04). Only limited results from a few studies were available on procedure and fluoroscopy time, radiation dose and CO2-related adverse events. The evidence suggests that the use of CO2 for peripheral vascular interventions reduces the risk of CA-AKI compared to ICM. However, due to the relevant residual risk of CA-AKI with the use of CO2, other AKI risk factors must be considered in patients undergoing peripheral vascular interventions.

10.
JACC Cardiovasc Interv ; 15(20): 2093-2102, 2022 10 24.
Article En | MEDLINE | ID: mdl-36265942

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).


Angioplasty, Balloon , Cardiovascular Agents , Peripheral Arterial Disease , Polychlorinated Biphenyls , Vascular Access Devices , Humans , Paclitaxel/adverse effects , Popliteal Artery/diagnostic imaging , Angioplasty, Balloon/adverse effects , Peripheral Arterial Disease/diagnostic imaging , Peripheral Arterial Disease/therapy , Prospective Studies , Pilot Projects , Cardiovascular Agents/adverse effects , Coated Materials, Biocompatible , Vascular Patency , Treatment Outcome , Time Factors , Femoral Artery/diagnostic imaging , Constriction, Pathologic
11.
Eur J Vasc Endovasc Surg ; 64(5): 516-525, 2022 11.
Article En | MEDLINE | ID: mdl-35973667

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.


Angioplasty, Balloon, Coronary , Angioplasty, Balloon , Peripheral Arterial Disease , Humans , Paclitaxel/adverse effects , Cohort Studies , Angioplasty, Balloon/adverse effects , Angioplasty, Balloon, Coronary/methods , Amputation, Surgical , Treatment Outcome , Coated Materials, Biocompatible , Peripheral Arterial Disease/diagnostic imaging , Peripheral Arterial Disease/surgery , Popliteal Artery , Vascular Patency
12.
JACC Case Rep ; 4(7): 424-428, 2022 Apr 06.
Article En | MEDLINE | ID: mdl-35693898

Stent fractures have been described after femoropopliteal interventions with relevant clinical sequelae, including restenosis and reocclusion. We report 2 cases of fractures of a novel interwoven nitinol stent with high radial strength and fracture resistance as a result of entrapment syndrome of the popliteal artery. (Level of Difficulty: Advanced.).

13.
Inn Med (Heidelb) ; 63(6): 584-590, 2022 Jun.
Article De | MEDLINE | ID: mdl-35532802

Successful revascularization of patients with peripheral arterial disease (PAD) requires a comprehensive understanding of the risk population and the available treatment options. Even the urgency of revascularization varies widely depending on the clinical presentation. Patients with intermittent claudication should undergo a structured exercise program before revascularization may become necessary, whereas acute limb ischemia is a medical emergency and must be revascularized within a few hours. Endovascular treatment techniques have evolved rapidly over the past 20 years. New technologies and procedural techniques allow even complex lesions to be successfully treated with endovascular techniques, and most patients can now be treated minimally invasively in line with an "endovascular first" strategy. Bypass surgery remains an important option for patients with advanced disease. The techniques used vary depending on the clinical presentation, location, and complexity of the lesion. Although the evidence for different techniques is limited, a variety of clinical and lesion factors are known to be critical for acute technical success and long-term patency rates. The use of paclitaxel-coated balloons and stents has been shown to significantly reduce restenosis and reintervention rates after femoropopliteal interventions. However, a late mortality signal associated with the use of these devices continues to be debated. After successful intervention, appropriate drug therapy and standardized follow-up should be established to prevent adverse limb events and reduce the high rate of cardiovascular events.


Angioplasty, Balloon , Endovascular Procedures , Peripheral Arterial Disease , Angioplasty, Balloon/adverse effects , Endovascular Procedures/adverse effects , Humans , Peripheral Arterial Disease/surgery , Popliteal Artery , Vascular Patency
14.
JACC Cardiovasc Interv ; 15(6): 618-626, 2022 03 28.
Article En | MEDLINE | ID: mdl-35219622

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).


Cardiovascular Agents , Drug-Eluting Stents , Peripheral Arterial Disease , Cardiovascular Agents/adverse effects , Femoral Artery/diagnostic imaging , Humans , Paclitaxel/adverse effects , Peripheral Arterial Disease/diagnostic imaging , Peripheral Arterial Disease/therapy , Popliteal Artery/diagnostic imaging , Sirolimus/adverse effects , Stents , Treatment Outcome , Vascular Patency
15.
J Endovasc Ther ; 29(5): 798-807, 2022 10.
Article En | MEDLINE | ID: mdl-34964369

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.


Arterial Occlusive Diseases , Peripheral Arterial Disease , Arterial Occlusive Diseases/diagnostic imaging , Arterial Occlusive Diseases/therapy , Calcium , Catheters , Chronic Disease , Femoral Artery/diagnostic imaging , Femoral Artery/surgery , Humans , Lower Extremity , Peripheral Arterial Disease/complications , Peripheral Arterial Disease/diagnostic imaging , Peripheral Arterial Disease/therapy , Popliteal Artery/surgery , Retrospective Studies , Treatment Outcome
16.
Zentralbl Chir ; 146(5): 486-492, 2021 Oct.
Article De | MEDLINE | ID: mdl-34666360

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.


Aortic Aneurysm, Thoracic , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Surgeons , Aortic Aneurysm, Thoracic/surgery , Blood Vessel Prosthesis , Humans , Postoperative Complications , Prosthesis Design , Retrospective Studies , Stents , Treatment Outcome
19.
Vasa ; 50(3): 186-192, 2021 Apr.
Article En | MEDLINE | ID: mdl-33559507

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.


Aortic Aneurysm, Thoracic , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Stroke , Aged , Aged, 80 and over , Aorta, Thoracic/diagnostic imaging , Aorta, Thoracic/surgery , Aortic Aneurysm, Thoracic/diagnostic imaging , Aortic Aneurysm, Thoracic/surgery , Blood Vessel Prosthesis , Blood Vessel Prosthesis Implantation/adverse effects , Endovascular Procedures/adverse effects , Female , Humans , Male , Middle Aged , Retrospective Studies , Risk Factors , Saline Solution , Stents , Stroke/etiology , Time Factors , Treatment Outcome
20.
J Cardiovasc Surg (Torino) ; 62(2): 118-123, 2021 Apr.
Article En | MEDLINE | ID: mdl-33635043

INTRODUCTION: Owing to the ageing of the population and rising rates of diabetes, more patients suffering from chronic limb threatening ischemia (CLTI) need revascularization for often complex, multilevel peripheral arterial occlusive disease. Below the knee (BTK) lesions are common in CLTI and short-term outcomes of BTK endovascular revascularizations have improved substantially over the last decade as a consequence of improved techniques and dedicated low profile devices. EVIDENCE ACQUISITION: The manuscript summarized the information identified through a limited literature review conducted on key resources including MEDLINE and EMBASE databases as well as conference proceedings. The keywords were "angioplasty," "endovascular intervention," "infrapopliteal," "tibial arteries" and "below the knee." The search was limited to contemporary English-language documents published between 2000 and 2020. EVIDENCE SYNTHESIS: Rates of re-stenosis and re-occlusion are high after infrapopliteal interventions limiting long-term success and necessitating frequent repeat procedures. CONCLUSIONS: In this article we aimed to summarize current knowledge regarding the need, options and outcome of repeat BTK interventions through a limited literature review and presentation of own data.


Arterial Occlusive Diseases/surgery , Endovascular Procedures/methods , Ischemia/surgery , Limb Salvage/methods , Lower Extremity/blood supply , Peripheral Arterial Disease/surgery , Humans , Recurrence
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