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1.
N Engl J Med ; 387(25): 2305-2316, 2022 12 22.
Article in English | MEDLINE | ID: mdl-36342173

ABSTRACT

BACKGROUND: Patients with chronic limb-threatening ischemia (CLTI) require revascularization to improve limb perfusion and thereby limit the risk of amputation. It is uncertain whether an initial strategy of endovascular therapy or surgical revascularization for CLTI is superior for improving limb outcomes. METHODS: In this international, randomized trial, we enrolled 1830 patients with CLTI and infrainguinal peripheral artery disease in two parallel-cohort trials. Patients who had a single segment of great saphenous vein that could be used for surgery were assigned to cohort 1. Patients who needed an alternative bypass conduit were assigned to cohort 2. The primary outcome was a composite of a major adverse limb event - which was defined as amputation above the ankle or a major limb reintervention (a new bypass graft or graft revision, thrombectomy, or thrombolysis) - or death from any cause. RESULTS: In cohort 1, after a median follow-up of 2.7 years, a primary-outcome event occurred in 302 of 709 patients (42.6%) in the surgical group and in 408 of 711 patients (57.4%) in the endovascular group (hazard ratio, 0.68; 95% confidence interval [CI], 0.59 to 0.79; P<0.001). In cohort 2, a primary-outcome event occurred in 83 of 194 patients (42.8%) in the surgical group and in 95 of 199 patients (47.7%) in the endovascular group (hazard ratio, 0.79; 95% CI, 0.58 to 1.06; P = 0.12) after a median follow-up of 1.6 years. The incidence of adverse events was similar in the two groups in the two cohorts. CONCLUSIONS: Among patients with CLTI who had an adequate great saphenous vein for surgical revascularization (cohort 1), the incidence of a major adverse limb event or death was significantly lower in the surgical group than in the endovascular group. Among the patients who lacked an adequate saphenous vein conduit (cohort 2), the outcomes in the two groups were similar. (Funded by the National Heart, Lung, and Blood Institute; BEST-CLI ClinicalTrials.gov number, NCT02060630.).


Subject(s)
Chronic Limb-Threatening Ischemia , Limb Salvage , Vascular Surgical Procedures , Humans , Chronic Limb-Threatening Ischemia/surgery , Chronic Limb-Threatening Ischemia/therapy , Endovascular Procedures/adverse effects , Endovascular Procedures/methods , Limb Salvage/adverse effects , Limb Salvage/methods , Retrospective Studies , Risk Factors , Treatment Outcome , Vascular Surgical Procedures/adverse effects , Vascular Surgical Procedures/methods , Saphenous Vein/transplantation
2.
Eur Heart J ; 45(15): 1303-1321, 2024 Apr 14.
Article in English | MEDLINE | ID: mdl-38461405

ABSTRACT

All guidelines worldwide strongly recommend exercise as a pillar of the management of patients affected by lower extremity peripheral artery disease (PAD). Exercise therapy in this setting presents different modalities, and a structured programme provides optimal results. This clinical consensus paper is intended for clinicians to promote and assist for the set-up of comprehensive exercise programmes to best advice in patients with symptomatic chronic PAD. Different exercise training protocols specific for patients with PAD are presented. Data on patient assessment and outcome measures are narratively described based on the current best evidence. The document ends by highlighting disparities in access to supervised exercise programmes across Europe and the series of gaps for evidence requiring further research.


Subject(s)
Intermittent Claudication , Peripheral Arterial Disease , Humans , Intermittent Claudication/therapy , Peripheral Arterial Disease/therapy , Exercise Therapy/methods , Exercise , Europe , Walking
3.
J Vasc Surg ; 79(4): 748-754.e2, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38013041

ABSTRACT

BACKGROUND: The mortality after ruptured abdominal aortic aneurysm (rAAA) repair is high, despite improvements in perioperative care, centralization of emergency vascular surgical services, and the introduction of endovascular aneurysm repair (EVAR). The diameter of intact AAA has been shown to be a predictor of short- and long-term survival. The aim of this study was to analyze the impact of AAA diameter on mortality for rAAA repair using contemporary data collected from the International Consortium of Vascular Registries and compare outcomes by sex and the type of repair patients received. METHODS: Prospective registry data on repair of rAAA from seven countries were collected from 2010 to 2016. The primary outcome was perioperative mortality after EVAR and open surgical repair (OSR). Data were stratified by type of repair and sex. Logistic regression models were used to estimate odds ratio (OR) for the association between AAA diameter and perioperative mortality and the association between type of repair and mortality. Multivariable logistic regression models were used to adjust for differences in patient characteristics. RESULTS: The study population consisted of 6428 patients with a mean age ranging from 70.2 to 75.4 years; the mean AAA diameter was 7.7 ± 1.8 cm. Females had a significantly smaller AAA diameter at presentation compared with males (6.9 ± 1.6 cm vs 7.9 ± 1.8 cm; P < .001). who underwent OSR had larger AAA diameters compared with those who underwent EVAR (P < .001). Females who underwent repair were significantly older (P < .001). Males were more likely to have cardiac disease, diabetes mellitus, and renal impairment. Overall, AAA diameter was a predictor of mortality in univariate and multivariate analysis. When analyzing EVAR and OSR separately, the impact of AAA diameter per cm increase on mortality was apparent in both males and females undergoing EVAR, but not OSR (EVAR: male OR, 1.09 [95% confidence interval, 1.03-1.16] and EVAR: female OR, 1.17 [95% confidence interval, 1.02-1.35]). The early mortality rate for males and females who underwent EVAR was 18.9% and 25.9% (P < .001), respectively. The corresponding mortality for males and females who underwent OSR was 30.2% and 38.6% (P < .001), respectively. CONCLUSIONS: In these real-world international data, there is a significant association between rAAA diameters and early mortality in males and females. This association was more evident in patients undergoing EVAR, but not shown in OSR. Despite improvements in overall AAA repair outcomes, the risk of mortality after rAAA repair is consistently higher for females.


Subject(s)
Aortic Aneurysm, Abdominal , Aortic Rupture , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Humans , Male , Female , Aged , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/surgery , Blood Vessel Prosthesis Implantation/adverse effects , Risk Factors , Endovascular Procedures/adverse effects , Treatment Outcome , Aortic Rupture/diagnostic imaging , Aortic Rupture/surgery , Registries , Retrospective Studies , Postoperative Complications/surgery
4.
J Vasc Surg ; 79(6): 1347-1359.e3, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38395093

ABSTRACT

BACKGROUND: The aim of this cohort study was to report the proportion of patients who develop periprocedural acute kidney injury (AKI) after endovascular repair (ER) and open surgery (OS) in patients with juxta/pararenal abdominal aortic aneurysm and to assess potential risk factors for AKI. The study also aimed to report the short- and long-term outcomes of patients with and without AKI. METHODS: This was a multicenter cohort study of five European academic high-volume centers (>50 OS or 50 ER infrarenal AAA repairs, plus >15 complex AAA repairs per year). All consecutively treated patients were extracted from a prospective vascular surgical registry and the data were scrutinized retrospectively. The primary end point for this study was the development of AKI. AKI was diagnosed when there is a two-fold increase of serum creatinine or decrease of glomerular filtration rate of >50% within 1 week of AAA repair. Secondary end points included long-term mortality and end-stage renal disease (ESRD). RESULTS: AKI occurred in 16.6% of patients in the ER group vs 30.3% in the OS group (P < .001). The 30-day mortality rate was higher among patients with AKI in both ER (15.4% vs 3.1%; P = .006) and OS (13.2% vs 5.3%; P = .001) groups. Age, chronic kidney disease, presence of significant thrombus burden in the pararenal region, >1000 mL blood loss in ER group were associated with development of AKI. Age, diabetes mellitus, chronic kidney disease, presence of significant thrombus burden in the pararenal region, and a proximal clamping time of >30 minutes in the OS group were associated with the development of AKI, whereas renal perfusion during clamping was the protective factor against AKI development. After a median follow-up of 91 months, AKI was associated with higher mortality rates in both the ER group (58.9% vs 29.7%; P < .001) and the OS group (61.5% vs 27.3%; P < .001). After the same follow-up period, AKI was associated with a higher incidence of ESRD in both the ER group (12.8% vs 3.6%; P = .009) and the OS group (9.9% vs 2.9%; P < .001). CONCLUSIONS: The current study identified important pre and postoperative factors associated with AKI after juxta/pararenal abdominal aortic aneurysm repair. Patients with postoperative AKI had significantly higher short- and long term mortality and higher incidence of ESRD than patients without AKI.


Subject(s)
Acute Kidney Injury , Aortic Aneurysm, Abdominal , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Registries , Humans , Acute Kidney Injury/etiology , Acute Kidney Injury/epidemiology , Acute Kidney Injury/mortality , Male , Aortic Aneurysm, Abdominal/surgery , Aortic Aneurysm, Abdominal/mortality , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/complications , Female , Endovascular Procedures/adverse effects , Endovascular Procedures/mortality , Aged , Risk Factors , Retrospective Studies , Time Factors , Treatment Outcome , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/mortality , Europe/epidemiology , Risk Assessment , Aged, 80 and over , Glomerular Filtration Rate , Middle Aged , Kidney Failure, Chronic/mortality , Creatinine/blood , Biomarkers/blood
5.
J Vasc Surg ; 2024 Jun 20.
Article in English | MEDLINE | ID: mdl-38908805

ABSTRACT

OBJECTIVE: The recent publication of randomized trials comparing open bypass surgery to endovascular therapy in chronic limb threatening ischemia (CLTI) patients, BEST-CLI and BASIL-2, has resulted in potentially contradictory findings. The trials differed significantly with respect to anatomic disease patterns and primary endpoints. We performed an analysis of BEST-CLI patients with significant infrapopliteal disease undergoing open tibial bypass or endovascular tibial interventions to formulate a relevant comparator to the outcomes reported from BASIL-2. METHODS: The study population consisted of BEST-CLI patients with adequate single segment saphenous vein conduit randomized to open bypass or endovascular intervention (Cohort 1) who additionally had significant infrapopliteal disease and underwent tibial level intervention. The primary outcome was major adverse limb event (MALE) or all-cause death. MALE included any major limb amputation or major re-intervention. Outcomes were evaluated using Cox proportional regression models. RESULTS: The analyzed subgroup included a total of 665 patients with 326 in the open tibial bypass group and 339 in the tibial endovascular intervention group. The primary outcome of MALE or all cause death at 3 years was significantly lower in the surgical group at 48.5% compared to 56.7% in the endovascular group (p=0.0018). Mortality was similar between groups (35.5% open vs. 35.8% endovascular; p=0.94 whereas MALE events were lower in the surgical group (23.3% vs. 35.0%; p<0.0001). This included a lower rate of major reinterventions in the surgical group (10.9%) compared to the endovascular group (20.2%; p=0.0006). Freedom from above ankle amputation or all-cause death was similar between treatment arms at 43.6% in the surgical group compared to 45.3% the endovascular group (p=0.30) however there were fewer above ankle amputations in the surgical group (13.5%) compared to the endovascular group (19.3%; p=0.0205). Perioperative (30-day) death was similar between treatment groups (2.5% open vs 2.4% endovascular; p=0.93) as was 30-day MACE (5.3% open vs 2.7% endovascular; p=0.12). CONCLUSIONS: Among patients with suitable single segment great saphenous vein who underwent infrapopliteal revascularization for CLTI, open bypass surgery was associated with a lower incidence of MALE or death and less major amputation compared to endovascular intervention. Amputation free survival was similar between the groups. Further investigations into differences in comorbidities, anatomic extent, and lesion complexity are needed to explain differences between the BEST-CLI and BASIL-2 reported outcomes.

6.
Diabetes Metab Res Rev ; 40(3): e3683, 2024 Mar.
Article in English | MEDLINE | ID: mdl-37477087

ABSTRACT

As a progressive disease process, early diagnosis and ongoing monitoring and treatment of lower limb peripheral artery disease (PAD) is critical to reduce the risk of diabetes-related foot ulcer (DFU) development, non-healing of wounds, infection and amputation, in addition to cardiovascular complications. There are a variety of non-invasive tests available to diagnose PAD at the bedside, but there is no consensus as to the most diagnostically accurate of these bedside investigations or their reliability for use as a method of ongoing monitoring. Therefore, the aim of this systematic review was to first determine the diagnostic accuracy of non-invasive bedside tests for identifying PAD compared to an imaging reference test and second to determine the intra- and inter-rater reliability of non-invasive bedside tests in adults with diabetes. A database search of Medline and Embase was conducted from 1980 to 30 November 2022. Prospective and retrospective investigations of the diagnostic accuracy of bedside testing in people with diabetes using an imaging reference standard and reliability studies of bedside testing techniques conducted in people with diabetes were eligible. Included studies of diagnostic accuracy were required to report adequate data to calculate the positive likelihood ratio (PLR) and negative likelihood ratio (NLR) which were the primary endpoints. The quality appraisal was conducted using the Quality Assessment of Diagnostic Accuracy Studies and Quality Appraisal of Reliability quality appraisal tools. From a total of 8517 abstracts retrieved, 40 studies met the inclusion criteria for the diagnostic accuracy component of the review and seven studies met the inclusion criteria for the reliability component of the review. Most studies investigated the diagnostic accuracy of ankle -brachial index (ABI) (N = 38). In people with and without DFU, PLRs ranged from 1.69 to 19.9 and NLRs from 0.29 to 0.84 indicating an ABI <0.9 increases the likelihood of disease (but the extent of the increase ranges from a small to large amount) and an ABI within the normal range (≥0.90 and <1.3) does not exclude PAD. For toe-brachial index (TBI), a threshold of <0.70 has a moderate ability to rule PAD in and out; however, this is based on limited evidence. Similarly, a small number of studies indicate that one or more monophasic Doppler waveforms in the pedal arteries is associated with the presence of PAD, whereas tri- or biphasic waveform suggests that PAD is less likely. Several forms of bedside testing may also be useful as adjunct tests and 7 studies were identified that investigated the reliability of bedside tests including ABI, toe pressure, TBI, transcutaneous oxygen pressure (TcPO2 ) and pulse palpation. Inter-rater reliability was poor for pulse palpation and moderate for TcPO2. The ABI, toe pressure and TBI may have good inter- and intra-rater reliability, but margins of error are wide, requiring a large change in the measurement for it to be considered a true change rather than error. There is currently no single bedside test or a combination of bedside tests that has been shown to have superior diagnostic accuracy for PAD in people with diabetes with or without DFU. However, an ABI <0.9 or >1.3, TBI of <0.70, and absent or monophasic pedal Doppler waveforms are useful to identify the presence of disease. The ability of the tests to exclude disease is variable and although reliability may be acceptable, evidence of error in the measurements means test results that are within normal limits should be considered with caution and in the context of other vascular assessment findings (e.g., pedal pulse palpation and clinical signs) and progress of DFU healing.


Subject(s)
Diabetes Mellitus , Diabetic Foot , Peripheral Arterial Disease , Adult , Humans , Prospective Studies , Retrospective Studies , Reproducibility of Results , Peripheral Arterial Disease/complications , Peripheral Arterial Disease/diagnosis , Diabetic Foot/etiology , Diabetic Foot/complications , Ankle Brachial Index
7.
Diabetes Metab Res Rev ; 40(3): e3700, 2024 Mar.
Article in English | MEDLINE | ID: mdl-37539634

ABSTRACT

INTRODUCTION: Peripheral artery disease (PAD) is associated with an increased likelihood of delayed or non-healing of a diabetes-related foot ulcer, gangrene, and amputation. The selection of the most effective surgical technique for revascularisation of the lower limb in this population is challenging and there is a lack of conclusive evidence to support the choice of intervention. This systematic review aimed to determine, in people with diabetes and tissue loss, if direct revascularisation is superior to indirect revascularisation and if endovascular revascularisation is superior to open revascularisation for the outcomes of wound healing, minor or major amputation, and adverse events including mortality. METHODS: Title and abstract searches of Medline, Embase, PubMed, and EBSCO were conducted from 1980 to 30th November 2022. Cohort and case-control studies and randomised controlled trials reporting comparative outcomes of direct (angiosome) revascularisation (DR) and indirect revascularisation (IR) or the comparative outcomes of endovascular revascularisation and open or hybrid revascularisation for the outcomes of healing, minor amputation, and major amputation in people with diabetes, PAD and tissue loss (including foot ulcer and/or gangrene) were eligible. Methodological quality was assessed using the Cochrane risk-of-bias tool for randomised trials, the ROBINS-I tool for non-randomised studies, and Newcastle-Ottawa Scale for observational and cohort studies where details regarding the allocation to intervention groups were not provided. RESULTS: From a total 7086 abstracts retrieved, 26 studies met the inclusion criteria for the comparison of direct angiosome revascularisation (DR) and indirect revascularisation (IR), and 11 studies met the inclusion criteria for the comparison of endovascular and open revascularisation. One study was included in both comparisons. Of the included studies, 35 were observational (31 retrospective and 4 prospective cohorts) and 1 was a randomised controlled trial. Cohort study quality was variable and generally low, with common sources of bias related to heterogeneous participant populations and interventions and lack of reporting of or adjusting for confounding factors. The randomised controlled trial had a low risk of bias. For studies of DR and IR, results were variable, and it is uncertain if one technique is superior to the other for healing, prevention of minor or major amputation, or mortality. However, the majority of studies reported that a greater proportion of participants receiving DR healed compared with IR, and that IR with collaterals may have similar outcomes to DR for wound healing. For patients with diabetes, infrainguinal PAD, and an adequate great saphenous vein available for use as a bypass conduit who were deemed suitable for either surgical procedure, an open revascularisation first approach was superior to endovascular therapy to prevent a major adverse limb event or death (Hazard Ratio: 0.72; 95% CI 0.61-0.86). For other studies of open and endovascular approaches, there was generally no difference in outcomes between the interventions. CONCLUSIONS: The majority of available evidence for the effectiveness of DR and IR and open and endovascular revascularisation for wound healing and prevention of minor and major amputation and adverse events including mortality in people with diabetes, PAD and tissue loss is inconclusive, and the certainty of evidence is very low. Data from one high quality randomised controlled trial supports the use of open over endovascular revascularisation to prevent a major limb event and death in people with diabetes, infrainguinal disease and tissue loss who have an adequate great saphenous vein available and who are deemed suitable for either approach.


Subject(s)
Diabetes Mellitus , Diabetic Foot , Peripheral Arterial Disease , Humans , Diabetic Foot/complications , Diabetic Foot/surgery , Gangrene/complications , Retrospective Studies , Cohort Studies , Prospective Studies , Lower Extremity , Peripheral Arterial Disease/complications , Peripheral Arterial Disease/surgery , Randomized Controlled Trials as Topic
8.
Diabetes Metab Res Rev ; 40(3): e3701, 2024 Mar.
Article in English | MEDLINE | ID: mdl-37493206

ABSTRACT

INTRODUCTION: The presence of peripheral artery disease (PAD) confers a significantly increased risk of failure to heal and major lower limb amputation for people with diabetes-related foot ulcer (DFU). Determining performance of non-invasive bedside tests for predicting likely DFU outcomes is therefore key to effective risk stratification of patients with DFU and PAD to guide management decisions. The aim of this systematic review was to determine the performance of non-invasive bedside tests for PAD to predict DFU healing, healing post-minor amputation, or need for minor or major amputation in people with diabetes and DFU or gangrene. METHODS: A database search of Medline and Embase was conducted from 1980 to 30 November 2022. Prospective studies that evaluated non-invasive bedside tests in patients with diabetes, with and without PAD and foot ulceration or gangrene to predict the outcomes of DFU healing, minor amputation, and major amputation with or without revascularisation, were eligible. Included studies were required to have a minimum 6-month follow-up period and report adequate data to calculate the positive likelihood ratio (PLR) and negative likelihood ratio for the outcomes of DFU healing, and minor and major amputation. Methodological quality was assessed using the Quality in Prognosis Studies tool. RESULTS: From 14,820 abstracts screened 28 prognostic studies met the inclusion criteria. The prognostic tests evaluated by the studies included: ankle-brachial index (ABI) in 9 studies; ankle pressures in 10 studies, toe-brachial index in 4 studies, toe pressure in 9 studies, transcutaneous oxygen pressure (TcPO2 ) in 7 studies, skin perfusion pressure in 5 studies, continuous wave Doppler (pedal waveforms) in 2 studies, pedal pulses in 3 studies, and ankle peak systolic velocity in 1 study. Study quality was variable. Common reasons for studies having a moderate or high risk of bias were poorly described study participation, attrition rates, and inadequate adjustment for confounders. In people with DFU, toe pressure ≥30 mmHg, TcPO2 ≥25 mmHg, and skin perfusion pressure of ≥40 mmHg were associated with a moderate to large increase in pretest probability of healing in people with DFU. Toe pressure ≥30 mmHg was associated with a moderate increase in healing post-minor amputation. An ABI using a threshold of ≥0.9 did not increase the pretest probability of DFU healing, whereas an ABI <0.5 was associated with a moderate increase in pretest probability of non-healing. Few studies investigated amputation outcomes. An ABI <0.4 demonstrated the largest increase in pretest probability of a major amputation (PLR ≥10). CONCLUSIONS: Prognostic capacity of bedside testing for DFU healing and amputation is variable. A toe pressure ≥30 mmHg, TcPO2 ≥25 mmHg, and skin perfusion pressure of ≥40 mmHg are associated with a moderate to large increase in pretest probability of healing in people with DFU. There are little data available evaluating the prognostic capacity of bedside testing for healing after minor amputation or for major amputation in people with DFU. Current evidence suggests that an ABI <0.4 may be associated with a large increase in risk of major amputation. The findings of this systematic review need to be interpreted in the context of limitations of available evidence, including varying rates of revascularisation, lack of post-revascularisation bedside testing, and heterogenous subpopulations.


Subject(s)
Diabetes Mellitus , Diabetic Foot , Foot Ulcer , Peripheral Arterial Disease , Humans , Diabetic Foot/diagnosis , Diabetic Foot/etiology , Diabetic Foot/surgery , Gangrene , Prospective Studies , Wound Healing , Amputation, Surgical/adverse effects , Peripheral Arterial Disease/complications , Peripheral Arterial Disease/diagnosis , Peripheral Arterial Disease/surgery , Point-of-Care Testing
9.
Diabetes Metab Res Rev ; 40(3): e3686, 2024 Mar.
Article in English | MEDLINE | ID: mdl-37726988

ABSTRACT

Diabetes related foot complications have become a major cause of morbidity and are implicated in most major and minor amputations globally. Approximately 50% of people with diabetes and a foot ulcer have peripheral artery disease (PAD) and the presence of PAD significantly increases the risk of adverse limb and cardiovascular events. The International Working Group on the Diabetic Foot (IWGDF) has published evidence based guidelines on the management and prevention of diabetes related foot complications since 1999. This guideline is an update of the 2019 IWGDF guideline on the diagnosis, prognosis and management of peripheral artery disease in people with diabetes mellitus and a foot ulcer. For this guideline the IWGDF, the European Society for Vascular Surgery and the Society for Vascular Surgery decided to collaborate to develop a consistent suite of recommendations relevant to clinicians in all countries. This guideline is based on three new systematic reviews. Using the Grading of Recommendations, Assessment, Development, and Evaluation framework clinically relevant questions were formulated, and the literature was systematically reviewed. After assessing the certainty of the evidence, recommendations were formulated which were weighed against the balance of benefits and harms, patient values, feasibility, acceptability, equity, resources required, and when available, costs. Through this process five recommendations were developed for diagnosing PAD in a person with diabetes, with and without a foot ulcer or gangrene. Five recommendations were developed for prognosis relating to estimating likelihood of healing and amputation outcomes in a person with diabetes and a foot ulcer or gangrene. Fifteen recommendations were developed related to PAD treatment encompassing prioritisation of people for revascularisation, the choice of a procedure and post-surgical care. In addition, the Writing Committee has highlighted key research questions where current evidence is lacking. The Writing Committee believes that following these recommendations will help healthcare professionals to provide better care and will reduce the burden of diabetes related foot complications.


Subject(s)
Diabetes Mellitus , Diabetic Foot , Foot Ulcer , Peripheral Arterial Disease , Humans , Diabetic Foot/diagnosis , Diabetic Foot/etiology , Diabetic Foot/prevention & control , Gangrene , Peripheral Arterial Disease/complications , Peripheral Arterial Disease/diagnosis , Lower Extremity
10.
J Endovasc Ther ; : 15266028241253133, 2024 May 26.
Article in English | MEDLINE | ID: mdl-38798060

ABSTRACT

CLINICAL IMPACT: Based on our study, no antithrombotic therapy is significantly associated with bridging stent occlusion, and no evidence of the superiority of other antithrombotic therapy exists. Nevertehless, due to the low number of bridging stent occlusions, this study can neither support nor reject the PRINCE2SS recommendations. Further studies with larger cohorts are needed to determine clear guideliness of the best antithrombotic treatment regimen after complex enfovascular aortic repair.

11.
Eur J Vasc Endovasc Surg ; 67(3): 435-443, 2024 Mar.
Article in English | MEDLINE | ID: mdl-37611731

ABSTRACT

OBJECTIVE: To compare the protective effect of Zero Gravity (ZG) with conventional radiation protection during endovascular aneurysm repair (EVAR). Secondly, user experience was surveyed with a questionnaire on ergonomics. METHODS: This was a single centre, prospective, randomised, two arm trial where 71 consecutive elective infrarenal EVAR procedures were randomised into two groups: (1) operator using ZG and assistant using conventional protection (n = 36), and (2) operator and assistant using conventional radiation protection (n = 35). A movable floor unit ZG system consists of a lead shield (1.0 mm Pb equivalent) for the front of the body and 0.5 mm Pb equivalent acrylic shielding for the head and neck. The ZG also includes arm flaps of 0.5 mm Pb equivalent covering the arm up to the elbow. Deep dose equivalent values, Hp(10) were measured with direct ion storage dosimeters (DIS) placed on various anatomical regions of the operator (axilla, chest, abdomen, and lower leg). Personal dose equivalent values, Hp(3) to eye lenses were measured in the operating and assisting surgeon using thermoluminescence dosimeters. The study was registered at the US National Institute of Health #NCT04078165. RESULTS: Protection with the standard protection was superior in chest (0.0 vs. 0.1 µSv), abdomen (0.0 vs. 0.6 µSv), and lower leg (0.4 vs. 2.2 µSv) (p < .001). On the other hand, the ZG system yielded better shielding for the axilla (1.5 vs. 0.0 µSv) and eyes (6.3 vs. 1.1 µSv) of the operator. The use of ZG hampered the deployment of ancillary shields, which is particularly relevant for protection of the assisting surgeon. Users found ZG more cumbersome than conventional garments, it also impaired communication and reduced field of view. CONCLUSION: Both ZG and conventional radiation protection reduced radiation exposure. Conventional protection allows better manoeuvrability at the price of wider exposure of the upper arm and axilla. ZG indirectly impaired protection of the assistant.


Subject(s)
Aortic Aneurysm, Abdominal , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Occupational Exposure , Radiation Protection , Humans , Radiation Protection/methods , Endovascular Aneurysm Repair , Radiation Dosage , Prospective Studies , Lead , Occupational Exposure/prevention & control , Radiography, Interventional
12.
Article in English | MEDLINE | ID: mdl-38925339

ABSTRACT

OBJECTIVE: BEST-CLI, an international randomised trial, compared bypass surgery with endovascular treatment in chronic limb threatening ischaemia (CLTI). In this substudy, overall amputation rates and risk of major amputation as an initial or subsequent outcome were evaluated. METHODS: A total of 1 830 patients were randomised to receive surgical or endovascular treatment:(1) patients with adequate single segment great saphenous vein (SSGSV) (n = 1 434); and (2) patients without adequate SSGSV (n = 396). Differences in time to first event and number of amputations were evaluated. RESULTS: In cohort 1, 410 (45.6%) total amputation events occurred in the surgical group vs. 490 (54.4%) in the endovascular group (p = .001) during mean follow up of 2.7 years. Every third patient underwent minor amputation after index revascularisation: 31.5% of the surgical group vs. 34.9% in the endovascular group (p = .17). Subsequent major amputation was required significantly less often in the surgical group compared with the endovascular group (15.0% vs. 25.6%; p = .002). The first amputation was major in 5.6% of patients in the surgical and 6.0% in the endovascular group (p = .72). Major amputation was required in 10.3% (n = 74/718) of patients in the surgical group and 14.9% (n = 107/716) in the endovascular group (p = .008). In cohort 2, 199 amputation events occurred in 132 (33.3%) patients during mean follow up of 1.6 years: 95 (47.7%) in the surgical vs. 104 (52.3%) in the endovascular group (p = .49). Major amputation was required in 15.2% (n = 30/197) of the patients in the surgical and 14.1% (n = 28/199) in the endovascular group (p = .74). CONCLUSION: In patients with CLTI, surgical bypass with SSGSV was more effective than endovascular treatment in preventing major amputations because of a decrease in major amputations subsequent to minor amputations.

13.
Article in English | MEDLINE | ID: mdl-38382695

ABSTRACT

OBJECTIVE: To determine the peri-operative mortality rate for intact and ruptured abdominal aortic aneurysm (AAA) repair in 10 countries and to compare practice and outcomes over a six year period by age, sex, and geographic location. METHODS: This VASCUNET study used prospectively collected data from vascular registries in 10 countries on primary repair of intact and ruptured AAAs undertaken between January 2014 and December 2019. The primary outcome was peri-operative death (30 day or in hospital). Logistic regression models were used to estimate the association between peri-operative death, patient characteristics, and type of procedure. Factors associated with the use of endovascular aortic aneurysm repair (EVAR) were also evaluated. RESULTS: The analysis included 50 642 intact and 9 453 ruptured AAA repairs. The proportion of EVARs for intact repairs increased from 63.4% in 2014 to 67.3% in 2016 before falling to 62.3% in 2019 (p < .001), but practice varied between countries. EVAR procedures were more common among older patients (p < .001) and men (p < .001). Overall peri-operative mortality after intact AAA repair was 1.4% (95% confidence interval [CI] 1.3 - 1.5%) and did not change over time. Mortality rates were stable within countries. Among ruptured AAA repairs, the proportion of EVARs increased from 23.7% in 2014 to 35.2% in 2019 (p < .001). The average aortic diameter was 7.8 cm for men and 7.0 cm for women (p < .001). The overall peri-operative mortality rate was 31.3% (95% CI 30.4 - 32.2%); the rates were 36.0% (95% CI 34.9 - 37.2%) for open repair and 19.7% (95% CI 18.2 - 21.3%) for EVAR. This difference and shift to EVAR reduced peri-operative mortality from 32.6% (in 2014) to 28.7% (in 2019). CONCLUSION: The international practice of intact AAA repair was associated with low mortality rates in registry reported data. There remains variation in the use of EVAR for intact AAAs across countries. Overall peri-operative mortality remains high after ruptured AAA, but an increased use of EVAR has reduced rates over time.

14.
Article in English | MEDLINE | ID: mdl-38467522

ABSTRACT

All guidelines worldwide strongly recommend exercise as a pillar in the management of patients affected by lower extremity peripheral artery disease (PAD). Exercise therapy in this setting presents different modalities, and a structured programme provides optimal results. This clinical consensus paper is intended to promote and assist the set up of comprehensive exercise programmes and best advice for patients with symptomatic chronic PAD. Different exercise training protocols specific for patients with PAD are presented. Data on patient assessment and outcome measures are described based on the current best evidence. The document ends by highlighting supervised exercise programme access disparities across Europe and the evidence gaps requiring further research.

15.
Ann Vasc Surg ; 100: 223-232, 2024 Mar.
Article in English | MEDLINE | ID: mdl-37926137

ABSTRACT

BACKGROUND: Surveillance after endovascular aneurysm repair (EVAR) is traditionally done with computed tomography angiography (CTA) scans that exposes patient to radiation, nephrotoxic contrast media, and potentially increased risk for cancer. Ultrasound (US) is less labor intensive and expensive and might thus provide a good alternative for CTA surveillance. The aim of this study was to evaluate in real-life patient cohorts whether US is able to detect post-EVAR aneurysm-related complications similarly to CTA. METHODS: This retrospective study compared the outcome of consecutive patients who underwent EVAR for intact abdominal aortic aneurysm and were surveilled solely by CTA (CTA-only cohort, n = 168) in 2000-2010 or by combined CTA and US (CTA/US cohort, n = 300) in 2011-2016, as a standard surveillance protocol in the department of vascular surgery, Helsinki University Hospital. The CTA-only patients were imaged at 1, 3, and 12 months and annually thereafter. The CTA/US patients were imaged with CTA at 3 and 12 months, US at 6 months and annually thereafter. If there were suspicion of >5 mm aneurysm growth, CTA scan was performed. The patients were reviewed for imaging data, reinterventions, aneurysm ruptures, and death until December 2018. The 2 groups were compared for secondary rupture, aneurysm-related and cancer-related death, reintervention related to abdominal aortic aneurysm, and maximum aneurysm diameter increase ≥5 mm. The mean follow-up in the CTA-only cohort was 67 months and in CTA/US cohort 43 months. RESULTS: The 2 cohorts were alike for basic characteristics and for the mean aneurysm diameter. The total number of CT scans for detecting aneurysm was 84.1/100 patient years in the CTA-only cohort compared to 74.5/100 patient years for US/CTA cohort. Forty percent of patients under combined CTA/US surveillance received 1 or more additional CTA scans. The 2 cohorts did not differ for 1-year, 5-year and 8-year freedom from aneurysm related death, secondary sac rupture, nor the incidence of rupture preventing interventions. CONCLUSIONS: Based on the follow-up data of this real-life cohort of 468 patients, combined surveillance with US and additional CTA either per protocol or due to suspicion of aneurysm-related complications had comparable outcome with sole CTA-surveillance. Thus, US can be considered a reasonable alternative for the CTA. However, our study showed also that the need of additional CTAs due to suspicion of endoleak or aneurysm nonrelated reasons is substantial.


Subject(s)
Aortic Aneurysm, Abdominal , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Neoplasms , Humans , Endovascular Aneurysm Repair , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/surgery , Aortic Aneurysm, Abdominal/complications , Blood Vessel Prosthesis Implantation/adverse effects , Retrospective Studies , Aortography/methods , Treatment Outcome , Endovascular Procedures/adverse effects , Endoleak/etiology , Neoplasms/complications
16.
Vasa ; 53(2): 87-108, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38461401

ABSTRACT

All guidelines worldwide strongly recommend exercise as a pillar in the management of patients affected by lower extremity peripheral artery disease (PAD). Exercise therapy in this setting presents different modalities, and a structured programme provides optimal results. This clinical consensus paper is intended to promote and assist the set up of comprehensive exercise programmes and best advice for patients with symptomatic chronic PAD. Different exercise training protocols specific for patients with PAD are presented. Data on patient assessment and outcome measures are described based on the current best evidence. The document ends by highlighting supervised exercise programme access disparities across Europe and the evidence gaps requiring further research.


Subject(s)
Intermittent Claudication , Peripheral Arterial Disease , Humans , Intermittent Claudication/therapy , Peripheral Arterial Disease/diagnosis , Peripheral Arterial Disease/therapy , Exercise Therapy/adverse effects , Exercise Therapy/methods , Exercise , Europe , Walking
17.
J Vasc Surg ; 77(1): 225-230, 2023 01.
Article in English | MEDLINE | ID: mdl-35987464

ABSTRACT

OBJECTIVE: Bovine pericardial patch (BPP) is currently used in femoral angioplasty as an alternative for autologous vein patch (AVP), but studies comparing the results of the two methods are scarce. In this retrospective study, we aimed to discover the differences between BPP and AVP closure in long-term durability. METHODS: This study consisted of all femoral endarterectomies with BPP closure performed in Helsinki University Hospital from January 1, 2014, to December 31, 2017. For comparison, the same number of consecutive patients who underwent femoral endarterectomy with AVP closure from January 1, 2014, to October 16, 2016, were reviewed. Follow-up ended December 31, 2020. The mean follow-up was 19 months (range, 0-74 months) in the BPP group and 22 months (range, 0-79 months) in the AVP group. The primary endpoint was primary patency. Secondary endpoints were restenosis at patch site detected by imaging or perioperatively, patch rupture, and deep surgical wound infection. Propensity score analysis was performed for adjustment of differences between the AVP and BPP groups. RESULTS: Overall primary patency was superior in the AVP group compared with the BPP group: at 1 year, 96.5% vs 85.0% and at 5 years, 83.0% vs 72.3% (P = .04). In propensity score-matched pairs (n = 92), no difference was found between the groups in primary patency: 95.7% and 95.7% at 1 year and 92.5% and 78.6% at 5 years (P = .861) or in freedom from restenosis: 100% and 100% at 1 year and 89.1% and 84.0% at 5 years (P = .057). Deep wound infections occurred slightly more often after BPP closure (8%) than after AVP closure (4%), but the difference was not statistically significant (P = .144). There were no patch ruptures in the BPP group, but in the AVP group, there were five ruptures (3.5%) (P = .024). CONCLUSIONS: BPP is compatible to AVP in femoral endarterectomy in patency and can be regarded as the safer choice considering the risk of patch rupture.


Subject(s)
Carotid Stenosis , Endarterectomy, Carotid , Humans , Cattle , Animals , Endarterectomy, Carotid/methods , Retrospective Studies , Treatment Outcome , Angioplasty/adverse effects , Angioplasty/methods , Carotid Stenosis/surgery
18.
J Vasc Surg ; 78(5): 1101-1131, 2023 Nov.
Article in English | MEDLINE | ID: mdl-37724985

ABSTRACT

Diabetes related foot complications have become a major cause of morbidity and are implicated in most major and minor amputations globally. Approximately 50% of people with diabetes and a foot ulcer have peripheral artery disease (PAD) and the presence of PAD significantly increases the risk of adverse limb and cardiovascular events. The International Working Group on the Diabetic Foot (IWGDF) has published evidence based guidelines on the management and prevention of diabetes related foot complications since 1999. This guideline is an update of the 2019 IWGDF guideline on the diagnosis, prognosis, and management of peripheral artery disease in people with diabetes mellitus and a foot ulcer. For this updated guideline, the IWGDF, the European Society for Vascular Surgery, and the Society for Vascular Surgery decided to collaborate to develop a consistent suite of recommendations relevant to clinicians in all countries. This guideline is based on three new systematic reviews. Using the Grading of Recommendations, Assessment, Development and Evaluation framework clinically relevant questions were formulated, and the literature was systematically reviewed. After assessing the certainty of the evidence, recommendations were formulated which were weighed against the balance of benefits and harms, patient values, feasibility, acceptability, equity, resources required, and when available, costs. Through this process five recommendations were developed for diagnosing PAD in a person with diabetes, with and without a foot ulcer or gangrene. Five recommendations were developed for prognosis relating to estimating likelihood of healing and amputation outcomes in a person with diabetes and a foot ulcer or gangrene. Fifteen recommendations were developed related to PAD treatment encompassing prioritisation of people for revascularisation, the choice of a procedure and post-surgical care. In addition, the Writing Committee has highlighted key research questions where current evidence is lacking. The Writing Committee believes that following these recommendations will help healthcare professionals to provide better care and will reduce the burden of diabetes related foot complications.

19.
Article in English | MEDLINE | ID: mdl-37995960

ABSTRACT

OBJECTIVE: Current guidelines recommend diameter monitoring of small and asymptomatic abdominal aortic aneurysms (AAAs) due to the low risk of rupture. Elective AAA repair is recommended for diameters ≥ 5.5 cm in men and ≥ 5.0 cm in women. However, data supporting the efficacy of elective treatment for all patients above these thresholds are diverging. For a subgroup of patients, life expectancy might be very short, and elective AAA repair at the current threshold may not be justified. This study aimed to externally validate a predictive model for survival of patients with an asymptomatic AAA treated by endovascular aneurysm repair (EVAR). METHODS: This was a multicentre international retrospective observational cohort study. Data were collected from four European aortic centres treating patients between 2001 and 2021. The initial model included age, estimated glomerular filtration rate (eGFR), and chronic obstructive pulmonary disease (COPD) as independent predictors for survival. Model performance was measured by discrimination and calibration. RESULTS: The validation cohort included 1 500 patients with a median follow up of 65 months, during which 54.6% of the patients died. The external validation showed slightly decreased discrimination ability and signs of overfitting in model calibration. However, a high risk subgroup of patients with impaired survival rates was identified: octogenarians with eGFR < 60 OR COPD, septuagenarians with eGFR < 30, and septuagenarians with eGFR < 60 and COPD having survival rates of only 55.2% and 15.5% at five and 10 years, respectively. CONCLUSION: EVAR is a valuable treatment option for AAA, especially for patients unsuitable for open repair. Nonetheless, not all these patients will benefit from EVAR, and an individualised treatment recommendation should include considerations on life expectancy. This study provides a risk stratification to identify patients who may not benefit from EVAR using the present diameter thresholds.

20.
Eur J Vasc Endovasc Surg ; 65(6): 828-836, 2023 06.
Article in English | MEDLINE | ID: mdl-36858252

ABSTRACT

OBJECTIVE: The aim of this study was to compare the short and long term clinical outcomes of endovascular (EVAR) vs. open surgical repair (OSR) of juxtarenal (JAAAs) and pararenal abdominal aortic aneurysms (PAAAs) in five high volume European academic centres. METHODS: This was a retrospective multicentre cohort study of five high volume European academic centres (> 50 open or 50 endovascular abdominal aortic aneurysm repairs annually) including 834 consecutive patients who were operated on and prospectively followed. Using propensity score matching (PSM) each patient who underwent OSR was matched with one patient who underwent EVAR in a 1:1 ratio (145 patients per group). The primary endpoint was long term all cause mortality, while the secondary endpoint was freedom from aortic related re-intervention. RESULTS: After a follow up of 87 months, no difference in overall survival between the two groups was observed (38.6% for EVAR vs. 42.1% for OSR; p = .88). Patients undergoing EVAR underwent aortic related re-interventions more frequently (24.1% vs. 6.9%; p < .001). Acute kidney injury (AKI) occurred more frequently in patients in the OSR group (40.7% vs. 24.8%; p = .006). However, most patients who suffered from AKI recovered without further progression to renal failure. In hospital (3.4% for EVAR vs. 4.1% for OSR; p = 1.0) and 30 day (4.1% for EVAR vs. 5.5% for OSR; p = .80) mortality rates did not differ between groups. CONCLUSION: Both open and endovascular treatment can be performed in high volume aortic centres with low short term mortality and morbidity rates, and good long term outcomes. These data provide useful information to help patients choose between the two procedures when both are feasible.


Subject(s)
Aortic Aneurysm, Abdominal , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Humans , Cohort Studies , Blood Vessel Prosthesis Implantation/adverse effects , Propensity Score , Endovascular Procedures/methods , Retrospective Studies , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/surgery , Treatment Outcome , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Risk Factors
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