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1.
J Clin Med ; 13(10)2024 May 08.
Artículo en Inglés | MEDLINE | ID: mdl-38792312

RESUMEN

Background/Objectives: Retrograde access of the peroneal artery (PA) is considered technically challenging and at risk of bleeding. The aim of this multicentre retrospective study was to assess the safety, feasibility, and technical success of this access route for infrainguinal endovascular recanalizations. Methods: We retrospectively analyzed 186 consecutive patients treated over a 7-year period (May 2014-August 2021) who underwent endovascular recanalization of infra-inguinal lesions using a PA access route. In all cases, retrograde PA access was obtained following a failed attempt to cross the occlusion via the antegrade route. Results: Among the 186 patients, 120 were males (60.5%) and the mean age was 76.8 ± 10.7 years old (44-94 years). One hundred and thirteen patients (60.7%) suffered from chronic limb threatening ischemia (CLTI). All patients presented with chronic total occlusions (CTO) and a failed conventional antegrade recanalization attempt. Retrograde access was performed under angiographic guidance in 185 cases (99.5%). It was successfully established in 171 cases (91.9%). The total rate of retrograde puncture-related complications was 2.1% (two puncture site bleedings of which one necessitated fasciotomy and two cases of arteriovenous fistulas managed conservatively). The Major Adverse Event (MAE) rate at 30 days was 1.6% (3/186). Conclusions: Retrograde recanalization of challenging infra-inguinal lesions via PA is safe and effective in experienced hands.

3.
Eur J Vasc Endovasc Surg ; 67(5): 799-808, 2024 May.
Artículo en Inglés | MEDLINE | ID: mdl-38182107

RESUMEN

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


Asunto(s)
Amputación Quirúrgica , Arteria Femoral , Enfermedad Arterial Periférica , Arteria Poplítea , Stents , Humanos , Anciano , Femenino , Masculino , Estudios Retrospectivos , Arteria Femoral/cirugía , Arteria Femoral/fisiopatología , Arteria Femoral/diagnóstico por imagen , Arteria Poplítea/cirugía , Arteria Poplítea/fisiopatología , Arteria Poplítea/diagnóstico por imagen , Enfermedad Arterial Periférica/cirugía , Enfermedad Arterial Periférica/fisiopatología , Enfermedad Arterial Periférica/terapia , Enfermedad Arterial Periférica/diagnóstico por imagen , Anciano de 80 o más Años , Estudios de Casos y Controles , Amputación Quirúrgica/estadística & datos numéricos , Recuperación del Miembro/métodos , Resultado del Tratamiento , Insuficiencia del Tratamiento , Índice de Severidad de la Enfermedad , Grado de Desobstrucción Vascular , Procedimientos Endovasculares/instrumentación , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/métodos
4.
J Vasc Surg Cases Innov Tech ; 9(4): 101343, 2023 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-37965110

RESUMEN

We describe the feasibility of covered endovascular reconstruction of the aortic bifurcation (CERAB) through a single femoral access and a steerable sheath. We present the technique, which we used for a patient with severe aortoiliac calcification and bilateral involvement of the common femoral artery. The patient underwent endarterectomy of the left common femoral artery plus CERAB with an aortic stent graft and bilateral covered stents for the common iliac artery with kissing dilatation with a steerable sheath using only left femoral access. CERAB can be performed using unilateral access with the aid of a steerable sheath, reducing the potential for access site complications.

5.
Catheter Cardiovasc Interv ; 102(4): 701-712, 2023 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-37560824

RESUMEN

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

7.
Vasa ; 52(3): 141-146, 2023 May.
Artículo en Inglés | MEDLINE | ID: mdl-36935626

RESUMEN

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.


Asunto(s)
Procedimientos Endovasculares , Enfermedad Arterial Periférica , Humanos , Resultado del Tratamiento , Procedimientos Endovasculares/efectos adversos , Hospitalización , Atención Ambulatoria , Enfermedad Arterial Periférica/diagnóstico por imagen , Enfermedad Arterial Periférica/terapia , Factores de Riesgo
8.
Vasa ; 52(3): 147-159, 2023 May.
Artículo en Inglés | MEDLINE | ID: mdl-36924047

RESUMEN

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


Asunto(s)
Procedimientos Endovasculares , Enfermedad Arterial Periférica , Humanos , Enfermedad Arterial Periférica/diagnóstico por imagen , Enfermedad Arterial Periférica/terapia , Procedimientos Endovasculares/efectos adversos , Angiografía , Cateterismo , Resultado del Tratamiento , Enfermedad Crónica
9.
J Cardiovasc Dev Dis ; 10(2)2023 Jan 29.
Artículo en Inglés | MEDLINE | ID: mdl-36826548

RESUMEN

Purpose, Retrograde recanalizations have gained increasing recognition in complex arterial occlusive disease. Re-entry devices are a well described adjunct for antegrade recanalizations. We present our experience with target balloon-assisted antegrade and retrograde recanalizations using re-entry devices in challenging chronic total occlusions. MATERIALS AND METHODS: We report data from a retrospective multicenter registry. Eligibility criteria included either antegrade or retrograde use of the OutbackTM or GoBackTM re-entry catheter in combination with a balloon as a target to accomplish wire passage, when conventional antegrade and retrograde recanalization attempts had been unsuccessful. Procedural outcomes included technical success (defined as wire passage though the occlusion and delivery of adjunctive therapy with <30% residual stenosis at final angiogram), safety (periprocedural complications, e.g., bleeding, vessel injury, or occlusion of the artery at the re-entry site, and distal embolizations), and clinical outcome (amputation-free survival and freedom from target lesion revascularization after 12-months follow-up). RESULTS: Thirty-six consecutive patients underwent target balloon-assisted recanalization attempts. Fourteen (39 %) patients had a history of open vascular surgery in the index limb. Fifteen patients were claudications (Rutherford Class 2 or 3, 21 presented with chronic limb threatening limb ischemia (Rutherford Class 4 to 6). The locations of the occlusive lesions were as follows: iliac arteries in 3 cases, femoropopliteal artery in 39 cases, and in below-the-knee arteries in 12 cases. In 15 cases, recanalization was attempted in multilevel occlusions. Retrograde access was attempted in 1 case in the common femoral artery, in the femoropopliteal segment in 10 cases, in below-the-knee arteries in 23 cases, and finally in 2 patients via the brachial artery. In 10 cases, the re-entry devices were inserted via the retrograde access site. Technical success was achieved in 34 (94 %) patients. There were 3 periprocedural complications, none directly related to the target balloon-assisted re-entry maneuver. Amputation-free survival was 87.8 % and freedom from clinically driven target lesion revascularization was 86.6 % after 12-months follow-up. CONCLUSION: Target balloon-assisted use of re-entry devices in chronic total occlusions provides an effective and safe endovascular adjunct, when conventional antegrade and retrograde recanalization attempts have failed.

10.
JACC Cardiovasc Interv ; 16(3): 317-331, 2023 02 13.
Artículo en Inglés | MEDLINE | ID: mdl-36792256

RESUMEN

A crossing algorithm was developed for the endovascular treatment of peripheral chronic total occlusive lesions (CTOs) to educate, guide, and appropriately influence clinical practice aiming at harmonization and standardization of endovascular procedures. The following steps are proposed: One, duplex sonography and if required computed tomography or magnetic resonance angiography for the selection of the optimal access site. Two, angiographic evaluation of the proximal/distal cap morphology, presence of collaterals at the origin of the proximal cap and at the distal vessel refilling site. In addition, evaluation of distal vessels, including their diameters and quality, and the presence of calcification or stents within the occlusion zone. Three, antegrade wiring strategies, guidewire (GW) and support catheter technology, as well as GW escalation strategies. Stop the antegrade attempt depending on clinical indication for peripheral artery disease treatment and the presence of retrograde options. Four, retrograde access site, support catheter, or sheath insertion and wiring technology from distally. Five, considering strategy change when progress cannot by achieved, using advanced bidirectional techniques and re-entry devices. Six, in case of successful GW passage from retrograde, GW externalization and treatment from antegrade. Management of the retrograde access by internal or external hemostasis at the end of the procedure. Alternatively, stop the procedure if no progress can be obtained within 3 hours or in case of specific complications. By establishing the algorithm in the daily routine of endovascular specialists, improvements in vessel- and patient-specific outcomes are anticipated. In addition, future research, and continuous collaboration between experts is warranted.


Asunto(s)
Procedimientos Endovasculares , Enfermedad Arterial Periférica , Humanos , Testimonio de Experto , Resultado del Tratamiento , Procedimientos Endovasculares/efectos adversos , Enfermedad Arterial Periférica/diagnóstico por imagen , Enfermedad Arterial Periférica/terapia , Algoritmos , Enfermedad Crónica
11.
J Clin Med ; 11(24)2022 Dec 08.
Artículo en Inglés | MEDLINE | ID: mdl-36555902

RESUMEN

Many patients with peripheral arterial disease (PAD) exhibit undiagnosed obstructive coronary artery disease. We aim to identify the patients with lifestyle limiting claudication due to PAD and without cardiac symptoms, requiring coronary revascularization based on high-sensitive troponin T (hsTnT) values. We assessed hsTnT in consecutive patients referred for elective endovascular treatment due to claudication [Rutherford categories (RC) 2 & 3] between January 2018 and December 2021. Diagnostic work-up by non-invasive imaging and, if required, cardiac catheterization was performed according to clinical data, ECG findings and baseline hsTnT. The occurrence of cardiac death, myocardial infarction or urgent revascularization during follow-up was the primary endpoint. Of 346 patients, 14 (4.0%) exhibited elevated hsTnT ≥ 14 ng/L, including 7 (2.0%) with acute myocardial injury by serial hsTnT sampling. Coronary revascularization by percutaneous coronary intervention was necessary in 6 of 332 (1.5%) patients with normal versus nine of 14 (64.3%) patients with elevated hsTnT (p < 0.001). During 2.4 ± 1.4 years of follow-up, 20 of 286 (7.0%) patients with normal versus four of 13 (30.8%) with elevated hsTnT at baseline reached the composite primary endpoint (p = 0.03 by log-rank test). In conclusion, elevated troponins in cardiac asymptomatic patients with claudication modify subsequent cardiac management and may increase the need for closer surveillance and more aggressive conservative management in polyvascular disease.

12.
JACC Cardiovasc Interv ; 15(20): 2093-2102, 2022 10 24.
Artículo en Inglés | MEDLINE | ID: mdl-36265942

RESUMEN

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).


Asunto(s)
Angioplastia de Balón , Fármacos Cardiovasculares , Enfermedad Arterial Periférica , Bifenilos Policlorados , Dispositivos de Acceso Vascular , Humanos , Paclitaxel/efectos adversos , Arteria Poplítea/diagnóstico por imagen , Angioplastia de Balón/efectos adversos , Enfermedad Arterial Periférica/diagnóstico por imagen , Enfermedad Arterial Periférica/terapia , Estudios Prospectivos , Proyectos Piloto , Fármacos Cardiovasculares/efectos adversos , Materiales Biocompatibles Revestidos , Grado de Desobstrucción Vascular , Resultado del Tratamiento , Factores de Tiempo , Arteria Femoral/diagnóstico por imagen , Constricción Patológica
13.
Cardiovasc Intervent Radiol ; 45(12): 1774-1783, 2022 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-36088609

RESUMEN

PURPOSE: This study aimed to assess 5-year effectiveness and safety of femoropopliteal angioplasty with the Luminor® 35 drug-coated balloon (DCB). MATERIALS AND METHODS: The EffPac trial was a prospective, multicenter, randomized controlled trial that enrolled 171 patients of Rutherford category 2 to 4 with medium length femoropopliteal lesions. Patients were allocated 1:1 to either Luminor® 35 DCB angioplasty or plain old balloon angioplasty (POBA). Assessment at 5 years included primary patency, freedom from clinically driven target lesion revascularization (CD-TLR), clinical improvement, and target limb amputation. Long-term vital status was ascertained in 97.1% of the participants. RESULTS: Kaplan-Meier curves at 5 years demonstrate a primary patency of 61.4% after DCB angioplasty and 53.5% after POBA (log-rank p = 0.040) with a decreasing difference throughout the observation period. Freedom from TLR was 82.1% and 73.7%, respectively (log-rank p = 0.050). Incidence of primary clinical improvement was similar between groups (61% DCB vs. 64% POBA, p = 0.94). Major target limb amputation was necessary in one POBA-group participant. Freedom from all-cause death at 5 years was 88.5% after DCB and 86.0% after POBA (log-rank p = 0.34). CONCLUSIONS: Primary patency after femoropopliteal DCB angioplasty remained superior to POBA throughout 5 years, however, with decreasing difference. Clinical improvement, freedom from TLR, and all-cause mortality were similar between groups over the long term. (Effectiveness of Paclitaxel-Coated Luminor® Balloon Catheter Versus Uncoated Balloon Catheter in the Superficial Femoral Artery [EffPac]; NCT02540018).


Asunto(s)
Angioplastia de Balón , Enfermedad Arterial Periférica , Humanos , Arteria Femoral/cirugía , Arteria Poplítea/diagnóstico por imagen , Arteria Poplítea/cirugía , Enfermedad Arterial Periférica/diagnóstico por imagen , Enfermedad Arterial Periférica/terapia , Estudios Prospectivos , Materiales Biocompatibles Revestidos , Grado de Desobstrucción Vascular , Resultado del Tratamiento , Factores de Tiempo , Angioplastia de Balón/métodos
14.
Vasa ; 51(4): 256-262, 2022 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-35604329

RESUMEN

Background: The search for an optimal interventional treatment strategy in infrapopliteal peripheral artery disease remains in the focus of interest. Whether drug-coated balloons (DCB) might enhance interventional outcomes after crural interventions is a matter of debate, as studies yielded conflicting results on DCB safety and efficacy. Patients and methods: We analyzed a retrospective cohort of 75 infrapopliteal DCB interventions performed at our institution in 68 patients with peripheral artery disease in Rutherford category 3 to 6. Results: Despite a high rate of long complex lesions and multi-vessel disease, freedom from clinically driven target lesions revascularization (TLR) after 365 days was 68%. After six months, healing or significant improvement of the ischemic ulcer was observed in 78% of cases. Accordingly, freedom from major amputation and death after 365 days was 82%. Freedom from major amputation and death was 76.2% of cases in patients with diabetes mellitus as opposed to 91.5% in patients without diabetes mellitus (p=0.049). Conclusions: With this real-world analysis we would like to contribute to the ongoing discussion on the benefit and safety of DCB treatment in below-the-knee interventions.


Asunto(s)
Angioplastia de Balón , Fármacos Cardiovasculares , Diabetes Mellitus , Enfermedad Arterial Periférica , Angioplastia de Balón/efectos adversos , Fármacos Cardiovasculares/efectos adversos , Materiales Biocompatibles Revestidos , Arteria Femoral , Humanos , Isquemia/diagnóstico por imagen , Isquemia/terapia , Recuperación del Miembro , Enfermedad Arterial Periférica/cirugía , Enfermedad Arterial Periférica/terapia , Arteria Poplítea/diagnóstico por imagen , Arteria Poplítea/cirugía , Estudios Retrospectivos , Factores de Tiempo , Resultado del Tratamiento , Grado de Desobstrucción Vascular
16.
J Endovasc Ther ; 29(6): 904-912, 2022 12.
Artículo en Inglés | MEDLINE | ID: mdl-34994234

RESUMEN

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).


Asunto(s)
Arteria Femoral , Enfermedad Arterial Periférica , Masculino , Humanos , Femenino , Arteria Femoral/diagnóstico por imagen , Enfermedad Arterial Periférica/diagnóstico por imagen , Enfermedad Arterial Periférica/terapia , Estudios Prospectivos , Grado de Desobstrucción Vascular , Diseño de Prótesis , Resultado del Tratamiento , Stents , Sistema de Registros , Arteria Poplítea
17.
J Endovasc Ther ; 29(6): 874-884, 2022 12.
Artículo en Inglés | MEDLINE | ID: mdl-35086385

RESUMEN

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


Asunto(s)
Angioplastia de Balón , Enfermedad Arterial Periférica , Adulto , Humanos , Proyectos Piloto , Arteria Poplítea/diagnóstico por imagen , Enfermedad Arterial Periférica/diagnóstico por imagen , Enfermedad Arterial Periférica/terapia , Grado de Desobstrucción Vascular , Materiales Biocompatibles Revestidos , Resultado del Tratamiento , Factores de Tiempo , Aterectomía/efectos adversos , Aterectomía/métodos , Angioplastia de Balón/efectos adversos , Arteria Femoral
19.
J Vasc Surg ; 75(1): 177-185.e1, 2022 01.
Artículo en Inglés | MEDLINE | ID: mdl-34302937

RESUMEN

OBJECTIVE/BACKGROUND: Retrograde recanalizations gained increasing recognition in complex arterial occlusive disease. Re-entry devices are a well-described adjunct for antegrade recanalizations. We present our experience with retrograde, infrainguinal recanalizations using the Outback re-entry catheter in challenging chronic total occlusions. METHODS: We report data from a retrospective multicenter registry in complex retrograde recanalizations. Eligibility criteria included retrograde infrainguinal use of the Outback re-entry catheter where both conventional antegrade and retrograde recanalizations had been unsuccessful. Procedural outcomes included technical success (defined as successful wire passage and delivery of adjunctive therapy with <30% residual stenosis), safety (periprocedural complications, eg, bleeding, vessel injury, or occlusion of the artery at the re-entry site, and distal embolizations), and clinical outcome (amputation-free survival and freedom from clinically driven target lesion revascularization [cd-TLR]). RESULTS: Forty-five consecutive patients underwent retrograde, infrainguinal recanalization attempts with the Outback re-entry catheter between February 2015 and August 2020. Thirty (67%) patients had a history of open vascular surgery in the index limb. In four patients, recanalizations were even more challenging due to previous surgical removal and/or ligation of the proximal segment of the superficial femoral artery. The retrograde access site of the Outback catheter was the femoropopliteal segment in 31 (69%) patients and crural vessels in 14 (31%) patients. The re-entry target sites were as follows: common femoral artery in 31 (69%) patients, superficial femoral artery in 9 (20%) patients, popliteal artery in 1 patient, and below-the-knee arteries in 2 patients. In four patients, the needle of the re-entry device was targeted to an inflated balloon, inserted via the antegrade route. The Outback re-entry catheter was placed via a 6-French sheath in 19 (42%) cases and sheathless in 26 (58%) cases. Technical success was achieved in 41 (91%) patients There were two instances of distal embolizations and three bleeding episodes. Amputation-free survival was 100% at 30 days, and after 12 months, freedom from cd-TLR was 95% at 30 days and 75% at 12 months of follow-up. Female sex was an independent predictor for cd-TLR at 12 months of follow-up. CONCLUSIONS: Retrograde use of the Outback re-entry catheter in infrainguinal chronic total occlusions provides an effective and safe endovascular adjunct, when conventional antegrade and retrograde recanalization attempts have failed.


Asunto(s)
Angioplastia/instrumentación , Arteriopatías Oclusivas/cirugía , Cateterismo Periférico/instrumentación , Complicaciones Posoperatorias/epidemiología , Anciano , Anciano de 80 o más Años , Angioplastia/efectos adversos , Angioplastia/métodos , Cateterismo Periférico/efectos adversos , Cateterismo Periférico/métodos , Catéteres/efectos adversos , Femenino , Arteria Femoral/cirugía , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Arteria Poplítea/cirugía , Complicaciones Posoperatorias/etiología , Estudios Retrospectivos , Stents/efectos adversos , Resultado del Tratamiento
20.
Clin Case Rep ; 9(4): 2077-2082, 2021 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-33936643

RESUMEN

We report on retrograde retrieval of the soft end of dislodged guidewires during complex interventions. Interventionalists may consider this as an option for the endovascular management of this complication if an antegrade retrieval is not possible or fails.

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