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OBJECTIVE: Peripheral arterial disease (PAD) has been associated with suboptimal treatment, high mortality, and high amputation rates. It is unclear how the COVID-19 (coronavirus disease 2019) pandemic affected this development in a long term context. METHODS: This is a registry based, retrospective, nationwide cohort study including patients hospitalised with PAD as a main or secondary diagnosis and amputation surgery between 2012 - 2021 in Germany. Primary endpoints were population wide major and minor amputation rates, in hospital death, and in hospital mortality rates. Secondary endpoints were same admission revascularisations and in hospital death in the event of complications, i.e., failure to rescue (FTR). Pre-pandemic and pandemic trends, focusing on lockdown periods, were analysed. RESULTS: A total of 365 926 patient records with PAD and amputation surgery were analysed. The median patient age was 75 years and 28.8% were female. Overall population wide amputation and in hospital mortality rates (monthly decrease -0.002/100 000, p < .001, and -0.001/100 000, p< .001, respectively) and in hospital mortality rate (8.0% for 2012 - 2014 vs. 6.5% for 2020 - 2021; p < .001) declined between 2012 and 2020. Concurrently, same admission revascularisations increased (41.0% for 2012 - 2014 vs. 47.0% for 2020 - 2021; p < .001), while FTR decreased in a subset of complications (acute ischaemia, major bleeding, compartment syndrome, and mesenterial ischaemia). In the first pandemic lockdown, there was a temporary trend change to higher major amputations rates (+0.02/100 000; p < .001) and higher in hospital mortality rates (+0.007/100 000; p < .001), which changed to a decrease as of the second lockdown (-0.03/100 000, p = .034, and -0.010/100 000, p < .001, respectively) in an interrupted time series analysis. There was no statistically significant change in observed amputation rates during lockdowns, while observed in hospital mortality rates decreased by 12.0% in the first lockdown (0.22/100 000 vs. 0.25/100 000; p = .005) compared with reference periods of the two previous years. CONCLUSION: Between 2012 and 2021, pre-pandemic trends toward decreasing population wide overall amputation rates, fewer major amputations, more amputation related revascularisation procedures, and lower in hospital mortality were maintained despite a temporary trend to increased major amputations and in hospital mortality during the first COVID-19 related lockdown in Germany.
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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.
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Hematopoyesis Clonal , Enfermedad Arterial Periférica , Humanos , Hematopoyesis Clonal/genética , Mutación , Enfermedad Arterial Periférica/genética , Proyectos PilotoRESUMEN
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.
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Arteriopatías Oclusivas , Enfermedad Arterial Periférica , Arteriopatías Oclusivas/diagnóstico por imagen , Arteriopatías Oclusivas/terapia , Calcio , Catéteres , Enfermedad Crónica , Arteria Femoral/diagnóstico por imagen , Arteria Femoral/cirugía , Humanos , Extremidad Inferior , Enfermedad Arterial Periférica/complicaciones , Enfermedad Arterial Periférica/diagnóstico por imagen , Enfermedad Arterial Periférica/terapia , Arteria Poplítea/cirugía , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
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.
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Angioplastia Coronaria con Balón , Angioplastia de Balón , Enfermedad Arterial Periférica , Humanos , Paclitaxel/efectos adversos , Estudios de Cohortes , Angioplastia de Balón/efectos adversos , Angioplastia Coronaria con Balón/métodos , Amputación Quirúrgica , Resultado del Tratamiento , Materiales Biocompatibles Revestidos , Enfermedad Arterial Periférica/diagnóstico por imagen , Enfermedad Arterial Periférica/cirugía , Arteria Poplítea , Grado de Desobstrucción VascularRESUMEN
OBJECTIVE: Type II endoleak (T2EL) is the most common endoleak after endovascular aneurysm repair (EVAR). Its optimal management has been controversially discussed. Thus, preliminary selective embolization of aneurysm sac side branches (ASSBs) has been adopted to prevent T2EL. Our goal was to determine the rate of T2EL and the diameter decrease of abdominal aortic aneurysms (AAAs) after EVAR performed after preemptive embolization of ASSBs. METHODS: From September 2014 to September 2019, 139 patients with AAAs underwent percutaneous ASSB embolization before EVAR. Follow-up imaging studies were performed at 1 and 6 months and annually thereafter. The end points included freedom from T2EL, AAA sac shrinkage, T2EL-related reinterventions, and all-cause mortality. RESULTS: The mean follow-up was 23 ± 16 months (range, 1-61 months). The patients had had a median of five (range, one to eight) patent ASSBs found on preoperative imaging studies. After completion of embolization, 76.4% of the initially patent ASSBs were occluded, with no major procedure-related complications. Follow-up imaging studies showed T2ELs in seven patients (5%), with an aneurysm sac increase seen in six of these patients. The number of ASSBs remaining patent after embolization was the only discriminative factor in patients with and without T2EL. Six T2EL-related reinterventions were performed during follow-up. Most patients (n = 91; 86.7%) had experienced aneurysm sac shrinkage, and the mean diameter reduction was 9.2 ± 7.7 mm (P < .001) in all patients with follow-up data available. One aneurysm-related death occurred within 30 days after EVAR. CONCLUSIONS: Preemptive embolization of ASSBs for patients with AAAs is safe and effective in preventing T2ELs after EVAR. Aneurysm sac shrinkage was observed in a high proportion of patients.
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Aneurisma de la Aorta Abdominal/cirugía , Implantación de Prótesis Vascular , Embolización Terapéutica , Endofuga/prevención & control , Procedimientos Endovasculares , Anciano , Anciano de 80 o más Años , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/mortalidad , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/mortalidad , Embolización Terapéutica/efectos adversos , Embolización Terapéutica/mortalidad , Endofuga/diagnóstico por imagen , Endofuga/etiología , Endofuga/mortalidad , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/mortalidad , Femenino , Humanos , Masculino , Factores Protectores , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Resultado del TratamientoRESUMEN
OBJECTIVE: The aim was to describe the outcomes of high risk patients with symptomatic or contained rupture of pararenal (PRAs) and thoraco-abdominal aortic aneurysms (TAAAs) with anatomy unsuitable for commercially available stent grafts who underwent fenestrated endovascular aneurysm repair (FEVAR) using physician modified stent grafts (PMSGs) planned with 3D image analysis software (3DIMAS), and 3D printed aortic models (3DAMs). METHODS: Nineteen consecutive patients (17 male; mean age, 70 ± 9 years) underwent PMSG-FEVAR between 2015 and 2019. 3DAMs to plan the PMSGs were introduced in 2018. End points were all cause mortality, freedom from any endoleak, target vessel patency, and re-intervention. RESULTS: Seven patients (36.8%) were treated with PMSGs using 3DIMAS (three PRAs, three type IV, and one type III TAAAs), and 12 patients (63.2%) received PMSGs using 3DAMs (five PRAs, seven type IV TAAAs). Six patients presented with contained aortic rupture and 13 patients were treated for symptomatic aortic aneurysm. Mean aortic diameter was 72 ± 10 mm. The choice of stent graft for fenestration was the Valiant Captivia Closed Web (Medtronic), except for one patient. Sixteen (84.2%) stent grafts were manufactured with four fenestrations. Technical success was 100%. Seventy-one renovisceral branch vessels were targeted with fenestrations. Mean length of hospital stay was 17.3 ± 10.4 days. Thirty day mortality was 0%. Two patients developed reversible spinal cord injury. Mean follow up was 14.4 months (range 1-52 months). During follow up one non-aneurysm related death occurred, and two successful re-interventions were performed: one to re-establish renal artery patency, and one to treat a type 1c endoleak. CONCLUSION: PMSGs for urgent treatment of pararenal and thoraco-abdominal aortic aneurysms in high risk patients unsuitable for commercially available stent grafts are feasible and safe. 3D printing technology may improve urgent construction of patient specific devices for treatment of complex aortic pathologies and improve outcomes.
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Aneurisma Roto/cirugía , Aneurisma de la Aorta Torácica/cirugía , Prótesis Vascular , Impresión Tridimensional , Diseño de Prótesis , Stents , Anciano , Anciano de 80 o más Años , Aneurisma Roto/patología , Aneurisma de la Aorta Torácica/patología , Implantación de Prótesis Vascular , Estudios de Cohortes , Femenino , Humanos , Masculino , Persona de Mediana Edad , Resultado del TratamientoRESUMEN
AIM: Since therapeutic hypothermia (TH) is known for its inhibitory effects on leucocyte migration and cytokine synthesis, our aim was to underline the necessity of early monitoring for potential immunomodulatory risks. METHODS: Using a 13-year retrospective case-control study at the paediatric intensive care unit (PICU) of the Medical University in Vienna, all newborn infants and children receiving TH were screened and compared with a diagnosis-matched control group undergoing conventional normothermic treatment (NT). TH was accomplished by using a non-invasive cooling device. Target temperature was 32-34°C. Children with evident infections, a medical history of an immunodeficiency or undergoing immunosuppressive therapy, were excluded. RESULTS: During the observational period, 108 patients were screened, 27 of which underwent TH. Culture-proven infections occurred in 22% of the TH group compared with 4% of the normothermic controls (P = .1). From the second day following PICU admission, median C-reactive protein (CRP) values were higher in the TH group (day two P = .002, day three P = .0002, day six P = .008). CONCLUSION: Children undergoing TH showed earlier and higher increases in CRP levels when compared to normothermic controls. These data underline the necessity of early and continuous monitoring for possible infectious complications.
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Hipotermia Inducida , Estudios de Casos y Controles , Niño , Frío , Humanos , Hipotermia Inducida/efectos adversos , Lactante , Recién Nacido , Unidades de Cuidado Intensivo Pediátrico , Estudios RetrospectivosRESUMEN
AIMS: Drug-coated balloons (DCBs) for femoropopliteal interventions have not been tested against each other. We aimed to directly compare efficacy and safety of a high-dose (In.Pact™) vs. low-dose (Ranger™) DCB with nominal paclitaxel densities of 3.5 vs. 2.0 µg/mm2. METHODS AND RESULTS: Within a prospective, multicentre, non-inferiority, clinical trial 414 patients with symptomatic femoropopliteal lesions (Rutherford classification 2-4) were randomly assigned in a 1:1 ratio to endovascular treatment with either high- or low-dose DCB after stratification for lesion length. Primary efficacy and safety endpoints comprised primary patency and freedom from major adverse events (i.e. device and procedure-related deaths through 1 month, major amputations, and clinically driven target lesion revascularization through 12 months). We set a non-inferiority margin of -10% at 12 months. Total occlusions were observed frequently (>40%) and provisional stenting was performed in every fourth intervention. Non-inferiority was determined for both primary efficacy and safety endpoints at 12 months. Primary patency was 81.5% in the high-dose and 83.0% in low-dose DCB group {difference: 1.5% [lower bound of the 90% two-sided confidence interval (CI) -5.2%]; Pnon-inferiority < 0.01}. Freedom from major adverse events was determined in 92.6% in high-dose and in 91.0% in low-dose DCB group [difference -1.6% (lower bound of the 90% two-sided CI -6.5%); Pnon-inferiority < 0.01]. Overall death rate was low (2.0%) and no major amputation occurred. CONCLUSION: Two DCBs with different coating characteristics exhibited comparable results with excellent effectiveness and safety through 12 months for femoropopliteal interventions including a wide range of lesion lengths. CLINICAL TRIAL REGISTRATION: The trial is registered with ClinicalTrials.gov (NCT02701543).
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Angioplastia de Balón , Fármacos Cardiovasculares , Enfermedad Arterial Periférica , Preparaciones Farmacéuticas , Materiales Biocompatibles Revestidos , Arteria Femoral , Humanos , Paclitaxel , Enfermedad Arterial Periférica/terapia , Arteria Poplítea , Estudios Prospectivos , Factores de Tiempo , Resultado del Tratamiento , Grado de Desobstrucción VascularRESUMEN
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.
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Aneurisma de la Aorta Torácica , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Accidente Cerebrovascular , Anciano , Anciano de 80 o más Años , Aorta Torácica/diagnóstico por imagen , Aorta Torácica/cirugía , Aneurisma de la Aorta Torácica/diagnóstico por imagen , Aneurisma de la Aorta Torácica/cirugía , Prótesis Vascular , Implantación de Prótesis Vascular/efectos adversos , Procedimientos Endovasculares/efectos adversos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Factores de Riesgo , Solución Salina , Stents , Accidente Cerebrovascular/etiología , Factores de Tiempo , Resultado del TratamientoRESUMEN
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.
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Aneurisma de la Aorta Torácica , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Cirujanos , Aneurisma de la Aorta Torácica/cirugía , Prótesis Vascular , Humanos , Complicaciones Posoperatorias , Diseño de Prótesis , Estudios Retrospectivos , Stents , Resultado del TratamientoRESUMEN
S-Adenosyl-l-homocysteine hydrolase (AdoHcy hydrolase; Sah1 in yeast/AHCY in mammals) degrades AdoHcy, a by-product and strong product inhibitor of S-adenosyl-l-methionine (AdoMet)-dependent methylation reactions, to adenosine and homocysteine (Hcy). This reaction is reversible, so any elevation of Hcy levels, such as in hyperhomocysteinemia (HHcy), drives the formation of AdoHcy, with detrimental consequences for cellular methylation reactions. HHcy, a pathological condition linked to cardiovascular and neurological disorders, as well as fatty liver among others, is associated with a deregulation of lipid metabolism. Here, we developed a yeast model of HHcy to identify mechanisms that dysregulate lipid metabolism. Hcy supplementation to wildtype cells up-regulated cellular fatty acid and triacylglycerol content and induced a shift in fatty acid composition, similar to changes observed in mutants lacking Sah1. Expression of the irreversible bacterial pathway for AdoHcy degradation in yeast allowed us to dissect the impact of AdoHcy accumulation on lipid metabolism from the impact of elevated Hcy. Expression of this pathway fully suppressed the growth deficit of sah1 mutants as well as the deregulation of lipid metabolism in both the sah1 mutant and Hcy-exposed wildtype, showing that AdoHcy accumulation mediates the deregulation of lipid metabolism in response to elevated Hcy in yeast. Furthermore, Hcy supplementation in yeast led to increased resistance to cerulenin, an inhibitor of fatty acid synthase, as well as to a concomitant decline of condensing enzymes involved in very long-chain fatty acid synthesis, in line with the observed shift in fatty acid content and composition.
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Adenosilhomocisteinasa/metabolismo , Ácidos Grasos/metabolismo , Metabolismo de los Lípidos , S-Adenosilhomocisteína/metabolismo , Proteínas de Saccharomyces cerevisiae/metabolismo , Saccharomyces cerevisiae/metabolismo , Adenosilhomocisteinasa/genética , Ácidos Grasos/genética , Hiperhomocisteinemia/genética , Hiperhomocisteinemia/metabolismo , Modelos Biológicos , Mutación , Saccharomyces cerevisiae/genética , Proteínas de Saccharomyces cerevisiae/genéticaRESUMEN
OBJECTIVE: The aim of this study was to determine the feasibility and safety of percutaneous axillary artery (AxA) access using vascular closure devices (VCD) for endovascular repair (ER) of thoraco-abdominal aortic aneurysms (TAAA) using fenestrated, branched, and chimney stent grafts. METHODS: Between September 2013 and December 2017, 40 high risk patients (27 men; mean age: 72.7 ± 7.4 years) with TAAA underwent total percutaneous endovascular aortic repair by percutaneous puncture of the third segment of the left AxA, using a 12F sheath for delivery of the bridging visceral stent grafts. Percutaneous closure was performed using ultrasound guidance and two Perclose ProGlide VCDs per puncture site. Endpoints were device success defined as successful haemostasis of the axillary puncture site by VCD, procedure success defined as endovascularly assisted haemostasis of the AxA, major cerebrovascular and peripheral neurological complications, and 30 day mortality. RESULTS: The median diameter of the AxA in the third segment was 6.5 mm (range 4.4-10.4 mm). The procedure success was 100%. Device success was achieved in 33 patients (82.5%). Device success in patients with AxA diameter >5 mm was 97%. All patients with diameter of the AxA <5 mm developed stenosis or occlusions of the vessel (n = 6), which were treated by percutaneous stent implantation. One bleeding at the AxA puncture site was treated with trans-femoral implantation of a covered stent. No secondary open procedures were required. No neurological deficit of the left upper limb was seen at discharge. Overall mortality at 30 days was 10%. CONCLUSIONS: Direct puncture of the AxA in the third segment and its use as an access vessel for large sheaths during total percutaneous treatment of complex endovascular aortic procedures appear to be feasible and safe in arteries with a diameter >5 mm. Complications can be managed using endovascular techniques.
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Aneurisma de la Aorta Torácica/cirugía , Cateterismo Periférico/métodos , Procedimientos Endovasculares/métodos , Stents , Anciano , Anciano de 80 o más Años , Aneurisma de la Aorta Torácica/diagnóstico , Aneurisma de la Aorta Torácica/mortalidad , Arteria Axilar , Angiografía por Tomografía Computarizada , Femenino , Estudios de Seguimiento , Alemania/epidemiología , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Tasa de Supervivencia/tendencias , Resultado del TratamientoRESUMEN
As only limited evidence is available for potential benefits of n-3 PUFA supplementation in patients with peripheral arterial disease (PAD), we studied the effects of 4 g n-3 PUFA on endothelial function and inflammatory markers. Seventy patients with stable PAD classified as Rutherford stage 2 or 3 and good control of cardiovascular factors were randomised to receive either 4 g n-3 PUFA or placebo daily for 3 months in a double-blind fashion. Primary endpoint was endothelial function assessed by flow-mediated vasodilation (FMD). In addition, ankle-brachial index, maximum and pain-free walking distances were determined. Lipid parameters including the omega-3 index reflecting n-3 PUFA intake as well as pro-inflammatory, endothelial and platelet activation markers were measured over the same time interval. After 3 months of treatment with 4 g n-3 PUFA daily, a significant improvement of FMD was observed compared with placebo (n-3 PUFA, median Δ 3·7 (interquartile range (IQR) -1·8, 7·1) % v. placebo, Δ -0·5 (IQR -6·5, 3·0) %, P = 0·01 between the groups). After a 3-month washout period, this benefit was not sustained (n-3 PUFA, median Δ 0·6 (IQR -2·2, 5·6) % v. placebo, Δ -0·9 (IQR -6·6, 6·7) %, P = 0·20). In response to n-3 PUFA, an improvement of lipid parameters with a pronounced increase in the omega-3 index was seen. No changes were found for other parameters. In conclusion, in patients with PAD, 4 g/d n-3 PUFA improved cardiovascular risk in PAD patients, which needs testing in large-scale trials.
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Endotelio Vascular/efectos de los fármacos , Ácidos Grasos Omega-3/farmacología , Enfermedad Arterial Periférica/fisiopatología , Anciano , Método Doble Ciego , Ácidos Grasos Omega-3/administración & dosificación , Ácidos Grasos Omega-3/uso terapéutico , Femenino , Humanos , Masculino , Persona de Mediana Edad , Enfermedad Arterial Periférica/terapia , PlacebosRESUMEN
Chronic critical lower limb ischemia (CLI) has been defined as ischemia that endangers the leg. An attempt was made to give a precise definition of CLI, based on clinical and hemodynamic data (Second European Consensus). CLI may be easily defined from a clinical point of view as rest pain of the distal foot or gangrene or ulceration. It is probably useful to add leg ulcers of other origin which do not heal because of severe ischemia, and to consider the impact of frailty on adverse outcome. From a hemodynamic viewpoint there is no consensus and most of the existing classifications are not based upon evidence. We should thus propose a definition and then validate it in a prospective cohort in order to define the patients at major risk of amputation, and also to define the categories of patients whose prognosis is improved by revascularisation. From today's available data, it seems clear that the patients with a systolic toe pressure (STP) below 30 mmHg must be revascularised whenever possible. However other patients with clinically suspected CLI and STP above 30 mmHg must be evaluated and treated in specialised vascular units and revascularisation has to be discussed on a case by case basis, taking into account other data such as the WiFi classification for ulcers.In conclusion, many useful but at times contradictory definitions of CLI have been suggested. Only a few have taken into account evidence, and none have been validated prospectively. This paper aims to address this and to give notice that a CLI registry within Europe will be set up to prospectively validate, or not, the previous and suggested definitions of CLI.
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Isquemia , Enfermedades Vasculares Periféricas , Amputación Quirúrgica , Europa (Continente) , Extremidades , Humanos , Estudios Prospectivos , Resultado del TratamientoRESUMEN
The development of new technologies and techniques has significantly advanced the field of endovascular peripheral interventions for chronic and acute limb ischemia over the last 20 years. Nowadays, the majority of patients with symptomatic peripheral arterial occlusive disease can be treated percutaneously using an endovascular first approach as a minimally invasive alternative to classical bypass surgery. Balloon angioplasty and stent implantation are the mainstays of endovascular interventions. For reconstruction of complex aortoiliac occlusions covered stents are frequently used. Patency rates after femoropopliteal interventions have been improved by the introduction of drug-eluting balloon and stent technologies. Advances in material and access techniques now enable the successful endovascular treatment of more complex infrapopliteal stenoses and occlusions.
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Angioplastia de Balón , Procedimientos Endovasculares/métodos , Extremidad Inferior/irrigación sanguínea , Enfermedad Arterial Periférica/cirugía , Stents , Angioplastia de Balón/métodos , Procedimientos Endovasculares/tendencias , Arteria Femoral/cirugía , Humanos , Claudicación Intermitente/cirugía , Isquemia/diagnóstico , Isquemia/etiología , Isquemia/fisiopatología , Isquemia/cirugía , Enfermedad Arterial Periférica/complicaciones , Enfermedad Arterial Periférica/diagnóstico , Enfermedad Arterial Periférica/fisiopatología , Arteria Poplítea/cirugía , Resultado del TratamientoRESUMEN
PURPOSE: To investigate outcomes of drug-coated balloon (DCB) angioplasty in endovascular interventions including or restricted to the popliteal artery. METHODS: A retrospective analysis was conducted of 266 patients [median age 72 years, interquartile range (IQR) 62, 78; 166 men] treated with DCB angioplasty in 281 de novo lesions including the popliteal artery between December 2011 and January 2015 at a single center. The median lesion length was 270 mm (IQR 150, 373). The study outcomes were primary patency and predictors of restenosis [reported as the hazard ratio (HR) with 95% confidence interval (CI)]. RESULTS: The primary patency was 77.4% at a median 12.2 months (IQR 5.7, 18.8). Independent variables associated with restenosis included baseline Rutherford category (HR 1.36, 95% CI 1.05 to 1.77, p=0.02), reference vessel diameter (HR 0.77, 95% CI 0.63 to 0.95, p=0.02), dissection (HR 1.69, 95% CI 1.022.79, p=0.04), and standard nitinol stent use (HR 2.08, 95% CI 1.14 to 3.79, p=0.02). CONCLUSION: Outcomes after DCB angioplasty in lesions including the popliteal artery were acceptable compared with previous studies. Further investigation with long-term follow-up is needed to confirm these results.
Asunto(s)
Angioplastia de Balón/instrumentación , Materiales Biocompatibles Revestidos , Enfermedad Arterial Periférica/terapia , Arteria Poplítea , Dispositivos de Acceso Vascular , Anciano , Angioplastia de Balón/efectos adversos , Diseño de Equipo , Femenino , Humanos , Masculino , Persona de Mediana Edad , Enfermedad Arterial Periférica/diagnóstico por imagen , Enfermedad Arterial Periférica/fisiopatología , Arteria Poplítea/diagnóstico por imagen , Arteria Poplítea/fisiopatología , Recurrencia , Estudios Retrospectivos , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento , Grado de Desobstrucción VascularRESUMEN
PURPOSE: To report midterm results of the "pave-and-crack" technique to facilitate safe and effective scaffolding of heavily calcified femoropopliteal lesions in preparation for delivery of a Supera interwoven stent. METHODS: Data were collected retrospectively on 67 consecutive patients (mean age 71±8 years; 54 men) treated with this technique between November 2011 and February 2017 at a single center. A third (22/64, 34%) of the patients had critical limb ischemia (CLI). Most lesions were TASC D (52/67, 78%), and the majority were occlusions (61/66, 92%). The mean lesion length was 26.9±11.2 cm. Nearly two-thirds (40/64, 62%) had grade 4 calcification (Peripheral Arterial Calcium Scoring System). To prepare for Supera stenting, the most heavily calcified segments of the lesion were predilated aggressively to obliterate recoil. A Viabahn stent-graft was then implanted to "pave" the lesion and protect from vessel rupture as aggressive predilation continued until the calcified plaque was "cracked" before lining the entire lesion with a Supera stent. Patency and target lesion revascularization (TLR) rates were estimated using the Kaplan-Meier method. RESULTS: Procedural success was achieved in 100% and technical success (residual stenosis <30%) in 98% (66/67). The mean cumulative stent lengths were 16±9 cm for the Viabahn and 23±12 cm for the Supera. Only 2 complications occurred (distal embolization and access-site pseudoaneurysm). Two CLI patients died within 30 days, and 3 patients (all claudicants) underwent a TLR. Patients were followed for a mean 19±18 months, during which another 2 CLI patients died and 1 patient had a major amputation. One-year primary and secondary patency estimates were 79% and 91%, respectively; freedom from TLR was 85%. CONCLUSION: Despite severe lesion calcification, patients experienced high technical success and a safe and durable therapy at midterm follow-up with the femoropopliteal "pave-and-crack" technique.
Asunto(s)
Angioplastia de Balón/métodos , Arteria Femoral , Isquemia/terapia , Enfermedad Arterial Periférica/terapia , Arteria Poplítea , Calcificación Vascular/terapia , Anciano , Angioplastia de Balón/efectos adversos , Angioplastia de Balón/instrumentación , Angioplastia de Balón/mortalidad , Enfermedad Crítica , Femenino , Arteria Femoral/diagnóstico por imagen , Humanos , Isquemia/diagnóstico por imagen , Isquemia/mortalidad , Masculino , Persona de Mediana Edad , Enfermedad Arterial Periférica/diagnóstico por imagen , Enfermedad Arterial Periférica/mortalidad , Arteria Poplítea/diagnóstico por imagen , Estudios Retrospectivos , Factores de Riesgo , Índice de Severidad de la Enfermedad , Stents , Factores de Tiempo , Resultado del Tratamiento , Calcificación Vascular/diagnóstico por imagen , Calcificación Vascular/mortalidad , Grado de Desobstrucción VascularRESUMEN
PURPOSE: To evaluate the safety and efficacy of the Igaki-Tamai biodegradable scaffold after drug-eluting balloon (DEB) angioplasty in patients with occlusive superficial femoral artery (SFA) disease. METHODS: A prospective, single-center, nonrandomized study enrolled 20 patients (mean age 66.7±11.6 years; 14 men) with symptomatic de novo SFA lesions undergoing angioplasty with the In.Pact Admiral paclitaxel-coated balloon and subsequent implantation of the Igaki-Tamai bioresorbable scaffold. All patients were claudicants. The average diameter stenosis was 89.7%, and the mean length was 43.6 mm. Clinical examinations with duplex sonography were performed after 1, 6, 9, and 12 months. The main study outcomes were technical success, restenosis, target lesion revascularization (TLR), ankle-brachial index (ABI) improvement, and changes in quality of life evaluated with the walking impairment questionnaire. Safety was assessed by monitoring the occurrence of adverse events. RESULTS: Angioplasty with a paclitaxel-coated balloon was performed in all patients, resulting in an average diameter stenosis of 24%. Subsequent implantation of the Igaki-Tamai scaffold reduced the average diameter stenosis to 3.5%. In the first 6 months, 2 cases of restenosis were reported, with no TLRs within that period. However, by the 12-month follow-up in 19 patients, 11 patients had lost in-stent patency. Among these patients, 8 had TLRs, which were the only adverse events recorded that were referable to the procedure. Quality-of-life assessments showed improvement in the majority of patients. CONCLUSION: The GAIA-DEB study shows that DEB treatment of the femoral artery prior to the implantation of the biodegradable Igaki-Tamai scaffold is safe. However, the antiproliferative actions of paclitaxel in the vessel wall were not effective in preventing restenosis. In-stent restenosis occurred predominantly after 6 months.
Asunto(s)
Implantes Absorbibles , Angioplastia de Balón/instrumentación , Fármacos Cardiovasculares/administración & dosificación , Materiales Biocompatibles Revestidos , Arteria Femoral , Paclitaxel/administración & dosificación , Enfermedad Arterial Periférica/terapia , Dispositivos de Acceso Vascular , Anciano , Angioplastia de Balón/efectos adversos , Índice Tobillo Braquial , Constricción Patológica , Femenino , Arteria Femoral/diagnóstico por imagen , Arteria Femoral/fisiopatología , Alemania , Humanos , Masculino , Persona de Mediana Edad , Enfermedad Arterial Periférica/diagnóstico , Enfermedad Arterial Periférica/fisiopatología , Proyectos Piloto , Estudios Prospectivos , Recurrencia , Retratamiento , Encuestas y Cuestionarios , Factores de Tiempo , Resultado del Tratamiento , Ultrasonografía Doppler Dúplex , Grado de Desobstrucción VascularRESUMEN
PURPOSE: To examine patient outcomes following the use of the Lutonix drug-coated balloon (DCB) in patients undergoing endovascular intervention in below-the-knee (BTK) arteries. METHODS: A retrospective chart review identified 248 patients who were treated for symptomatic peripheral artery disease with the Lutonix DCB between May 2013 and October 2014. Forty patients were lost to follow-up, leaving 208 patients (mean age 74.1±9.7 years; 138 men) with evaluable data for outcome analysis. The patient cohort suffered from either severe claudication (38.6%) or critical limb ischemia (CLI; 61.4%) in 220 limbs. Almost two-thirds (140, 63.6%) of the 220 target lesions were total occlusions, and 37 (17.8%) of all patients had occlusion of all 3 BTK vessels before intervention. RESULTS: Over a median 9-month follow-up, target lesion revascularization occurred in 15.9% of patients with an average time to first reintervention of 8 months. In total, 39 amputations were performed in 31 limbs. However, 17 of these amputations were preplanned minor amputations below the ankle; only 9 (4.1%) major amputations occurred corresponding to 6.6% of the CLI cohort. Freedom from the composite of death or major amputation was estimated as 92% and 85% at 6 and 12 months, respectively, by Kaplan-Meier analysis. In the full cohort, improvement of at least 1 Rutherford category was seen in 130 (59.1%) limbs after 1 year or at the last follow-up, with 104 (80.0%) of those limbs showing an improvement of ≥2 categories. CONCLUSION: From this single-center experience, the Lutonix DCB shows therapeutic promise in a disease state where new treatment options are needed.
Asunto(s)
Angioplastia de Balón/instrumentación , Fármacos Cardiovasculares/administración & dosificación , Materiales Biocompatibles Revestidos , Claudicación Intermitente/terapia , Isquemia/terapia , Paclitaxel/administración & dosificación , Enfermedad Arterial Periférica/terapia , Arteria Poplítea , Dispositivos de Acceso Vascular , Anciano , Anciano de 80 o más Años , Amputación Quirúrgica , Angioplastia de Balón/efectos adversos , Angioplastia de Balón/mortalidad , Constricción Patológica , Femenino , Alemania , Humanos , Claudicación Intermitente/diagnóstico por imagen , Claudicación Intermitente/mortalidad , Claudicación Intermitente/fisiopatología , Isquemia/diagnóstico por imagen , Isquemia/mortalidad , Isquemia/fisiopatología , Estimación de Kaplan-Meier , Recuperación del Miembro , Masculino , Enfermedad Arterial Periférica/diagnóstico por imagen , Enfermedad Arterial Periférica/mortalidad , Enfermedad Arterial Periférica/fisiopatología , Arteria Poplítea/diagnóstico por imagen , Arteria Poplítea/fisiopatología , Recurrencia , Estudios Retrospectivos , Factores de Tiempo , Resultado del Tratamiento , Grado de Desobstrucción VascularRESUMEN
PURPOSE: To describe and compare primary patency rates in patients undergoing endovascular femoropopliteal interventions with standard or interwoven nitinol stents or drug-coated balloons. METHODS: A cohort of 1292 patients was treated for symptomatic femoropopliteal occlusive disease classified as Rutherford category ≥ 1 at a large vascular center between June 2006 and August 2013 using either standard nitinol stents (SNS; n=432), interwoven nitinol stents (INS; n=470), or drug-coated balloons (DCB; n=390). Primary patency rates were assessed by ultrasound or angiographic readings for over 3 years of follow-up. Propensity score-matched pairs were formed to compare each treatment with another using survival analysis. RESULTS: Survival curves of primary patency favored INS compared with SNS in 368 propensity score-matched pairs (p<0.001). Kaplan-Meier estimates at 1, 2, and 3 years were 86.6%, 76.4%, and 68.9%, respectively, in the INS group vs 60.5%, 46.1%, and 42.1%, respectively, in the SNS group. No significant difference (p=0.232) was seen for the comparison of SNS vs DCB in 284 matched pairs over long-term follow-up (primary patency estimates at 1, 2, and 3 years were 79.8%, 53.8%, and 32.9%, respectively, in the DCB group vs 60.5%, 44.8%, and 40.3%, respectively, in the SNS group). Survival curves of primary patency favored INS over DCB in 254 matched pairs (p<0.001). Kaplan-Meier estimates at 1, 2, and 3 years were 79.0%, 51.2%, and 30.1%, respectively, in the DCB group vs 89.0%, 76.9%, and 66.2%, respectively, in the INS group. CONCLUSION: Propensity score-based analysis of primary patency suggests profound differences in restenosis rates between various treatment modalities for femoropopliteal disease for over 3 years of follow-up.