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1.
Cochrane Database Syst Rev ; 2: CD014717, 2024 02 14.
Artículo en Inglés | MEDLINE | ID: mdl-38353263

RESUMEN

BACKGROUND: Peripheral arterial disease (PAD) is the obstruction or narrowing of the large arteries of the lower limbs, which can result in impaired oxygen supply to the muscle and other tissues during exercise, or even at rest in more severe cases. PAD is classified into five categories (Fontaine classification). It may be asymptomatic or various levels of claudication pain may be present; at a later stage, there may be ulceration or gangrene of the limb, with amputation occasionally being required. About 20% of people with PAD suffer from intermittent claudication (IC), which is muscular discomfort in the lower extremities induced by exertion and relieved by rest within 10 minutes; IC causes restriction of movement in daily life. Treatment for people with IC involves addressing lifestyle risk factors. Exercise is an important part of treatment, but supervised exercise programmes for individuals with IC have low engagement levels and high attrition rates. The use of mobile technologies has been suggested as a new way to engage people with IC in walking exercise interventions. The novelty of the intervention, low cost for the user, automation, and ease of access are some of the advantages mobile health (mhealth) technologies provide that give them the potential to be effective in boosting physical activity in adults. OBJECTIVES: To assess the benefits and harms of mobile health (mhealth) technologies to improve walking distance in people with intermittent claudication. SEARCH METHODS: The Cochrane Vascular Information Specialist conducted systematic searches of the Cochrane Vascular Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and CINAHL, and also searched the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) and ClinicalTrials.gov. The most recent searches were carried out on 19 December 2022. SELECTION CRITERIA: We included randomised controlled trials (RCTs) in people aged 18 years or over with symptomatic PAD and a clinical diagnosis of IC. We included RCTs comparing mhealth interventions to improve walking distance versus usual care (no intervention or non-exercise advice), exercise advice, or supervised exercise programmes. We excluded people with chronic limb-threatening ischaemia (Fontaine III and IV). DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcomes were change in absolute walking distance from baseline, change in claudication distance from baseline, amputation-free survival, revascularisation-free survival. Our secondary outcomes were major adverse cardiovascular events, major adverse limb events, above-ankle amputation, quality of life, and adverse events. We used GRADE to assess the certainty of the evidence. MAIN RESULTS: We included four RCTs involving a total of 614 participants with a clinical diagnosis of IC. The duration of intervention of the four included RCTs ranged from 3 to 12 months. Participants were randomised to either mhealth or control (usual care or supervised exercise programme). All four studies had an unclear or high risk of bias in one or several domains. The most prevalent risk of bias was in the area of performance bias, which was rated high risk as it is not possible to blind participants and personnel in this type of trial. Based on GRADE criteria, we downgraded the certainty of the evidence to low, due to concerns about risk of bias, imprecision, and clinical inconsistency. Comparing mhealth with usual care, there was no clear evidence of an effect on absolute walking distance (mean difference 9.99 metres, 95% confidence interval (CI) -27.96 to 47.93; 2 studies, 503 participants; low-certainty evidence). None of the included studies reported on change in claudication walking distance, amputation-free survival, or revascularisation-free survival. Only one study reported on major adverse cardiovascular events (MACE) and found no clear difference between groups (risk ratio 1.37, 95% CI 0.07 to 28.17; 1 study, 305 participants; low-certainty evidence). None of the included studies reported on major adverse limb events (MALE) or above-ankle amputations. AUTHORS' CONCLUSIONS: Mobile health technologies can be used to provide lifestyle interventions for people with chronic conditions, such as IC. We identified a limited number of studies that met our inclusion criteria. We found no clear difference between mhealth and usual care in improving absolute walking distance in people with IC; however, we judged the evidence to be low certainty. Larger, well-designed RCTs are needed to provide adequate statistical power to reliably evaluate the effects of mhealth technologies on walking distance in people with IC.


Asunto(s)
Claudicación Intermitente , Enfermedad Arterial Periférica , Adulto , Humanos , Claudicación Intermitente/tratamiento farmacológico , Enfermedad Arterial Periférica/complicaciones , Enfermedad Arterial Periférica/terapia , Terapia por Ejercicio/métodos , Caminata , Extremidad Inferior , Ensayos Clínicos Controlados Aleatorios como Asunto
2.
Vascular ; 31(5): 989-993, 2023 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-35491989

RESUMEN

OBJECTIVES: Few studies have reported on the safety and durability of adipose-derived stem cells (ADSCs) to support healing in patients with venous leg ulcers (VLU). To establish if there is any evidence to support ADSC use in VLU patients, a systematic review was conducted. METHODS: A systematic review was conducted following the PRISMA guidelines. PubMed and Embase databases were searched for relevant papers. References from retrieved papers were reviewed to identify any extra eligible studies. RESULTS: After duplicate removal, 950 papers were screened for eligibility of which 932 were excluded based on title and abstract. Four papers were included in the final analysis (one randomised study and three non-randomised studies). 66 patients in total received ADSCs for VLU treatment. The only randomised paper reported 6-month healing rates of 75% with ADSCs compared to 50% in controls. 100% healing was achieved in one study. The remaining 2 studies reported 25% and 58% healing; however, they included patients with relatively large VLUs. Pain scores decreased after ADSCs application where reported. No serious procedure related complications were reported. CONCLUSION: ADSCs may enhance ulcer healing in patients with chronic VLU and appears safe based on initial reports. Large, randomised trials are needed to definitively establish the technique's role in VLU patients.


Asunto(s)
Úlcera Varicosa , Humanos , Úlcera Varicosa/terapia , Úlcera , Cicatrización de Heridas , Células Madre
3.
Cochrane Database Syst Rev ; 4: CD012926, 2022 04 01.
Artículo en Inglés | MEDLINE | ID: mdl-35363887

RESUMEN

BACKGROUND: Thoracoabdominal aortic aneurysms (TAAAs) are a life-threatening condition which remain difficult to treat. Endovascular and open surgical repair (OSR) provide treatment options for patients, however, due to the lack of clinical trials comparing these, the optimum treatment option is unknown. OBJECTIVES: To assess the effectiveness and safety of endovascular repair versus conventional OSR for the treatment of TAAAs. SEARCH METHODS: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL and AMED databases and World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 26 April 2021. We also searched references of relevant articles retrieved from the electronic search for additional citations. SELECTION CRITERIA: We considered all published and unpublished randomised controlled trials (RCTs) and controlled clinical trials (CCTs) comparing endovascular repair to OSR for TAAAs for inclusion in the review. The main outcomes of interest were prevention of aneurysm rupture (participants without aneurysm rupture up to 5 years from intervention), aneurysm-related mortality (30 days and 12 months), all-cause mortality, spinal cord ischaemia (paraplegia, paraparesis), visceral arterial branch compromise causing mesenteric ischaemia or renal failure, and rate of reintervention. DATA COLLECTION AND ANALYSIS: Two review authors independently screened all titles and abstracts identified from the searches to identify those that met the inclusion criteria. We planned to undertake data collection, risk of bias assessment, and analysis in accordance with Cochrane recommendations. We planned to assess the certainty of the evidence using GRADE. MAIN RESULTS: No RCTs or CCTs met the inclusion criteria for this review. AUTHORS' CONCLUSIONS: Due to the lack of RCTs or CCTs, we were unable to determine the safety and effectiveness of endovascular compared to OSR in patients with TAAAs and are unable to provide any evidence on the optimal surgical intervention for this cohort of patients. High-quality RCTs or CCTs addressing this objective are necessary, however conducting such studies will be logistically and ethically challenging for this life-threatening disease.


Asunto(s)
Aneurisma de la Aorta Torácica , Procedimientos Endovasculares , Aneurisma de la Aorta Torácica/cirugía , Arterias , Humanos
4.
Ann Vasc Surg ; 73: 234-243, 2021 May.
Artículo en Inglés | MEDLINE | ID: mdl-33359690

RESUMEN

BACKGROUND: Endovascular therapy (EVT) is being adopted by many surgeons as a suitable first choice in the treatment of most femoropopliteal disease when clinically indicated. However, there are multiple factors affecting the outcome of EVT including the anatomy of lesions and distal runoff status. The evidence of runoff effect on the outcome of superficial femoral artery (SFA) interventions is still scarce and not well studied in the current literature. The aim of this study was to investigate the effect of runoff score on the outcomes of SFA endovascular interventions. METHODS: Retrospective analysis was carried out on prospectively collected data on patients who underwent SFA endovascular intervention for critical limb ischemia (CLI) in a single tertiary center. Patients with Rutherford categories 4, 5, and 6 who did not have any previous vascular interventions were included in the study. The modified SVS runoff score was used after calculating scores from popliteal and all tibial vessels. Runoff was stratified into good (score <5), compromised (score 5-10), and poor (score >10). Amputation-free survival, patency rates, and overall survival were compared between all groups at 5 years. RESULTS: Between 2011 and 2018, 254 procedures were performed in 220 patients. Technical success was >92%; 66 patients required SFA stents, and 55 had concomitant tibial angioplasty. There was no significant difference between good, compromised, or poor runoff groups regarding complication rates, with 3.5% overall perioperative mortality (5 cases in the compromised group and 4 in the poor runoff group). A runoff score of <5 was associated with significantly marked clinical improvement (P < 0.001). Patency rates were significantly worse in the compromised and poor runoff groups, with 5-year cumulative primary patency rates of 80%, 50%, and 22% in the good, compromised, and poor runoff groups, respectively (P < 0.001). Amputation-free survival worsened as the runoff got poorer with 98%, 91%, and 78% in the good, compromised, and poor runoff groups, respectively, at 5 years (P < 0.001). SFA stenting and concomitant tibial angioplasty led to slight improvement in patency rates in the poor runoff group. CONCLUSIONS: Poor runoff with a score of >10 was associated with significantly reduced amputation-free survival and patency rates at 5 years in patients undergoing SFA endovascular intervention for CLI. Patients with a runoff score of <5 showed marked clinical improvement postoperatively when compared with patients with a runoff score of ≥5.


Asunto(s)
Procedimientos Endovasculares , Arteria Femoral/fisiopatología , Hemodinámica , Isquemia/terapia , Enfermedad Arterial Periférica/terapia , Anciano , Anciano de 80 o más Años , Amputación Quirúrgica , Enfermedad Crítica , Procedimientos Endovasculares/efectos adversos , Femenino , Arteria Femoral/diagnóstico por imagen , Humanos , Isquemia/diagnóstico por imagen , Isquemia/fisiopatología , Masculino , Persona de Mediana Edad , Enfermedad Arterial Periférica/diagnóstico por imagen , Enfermedad Arterial Periférica/fisiopatología , Supervivencia sin Progresión , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Grado de Desobstrucción Vascular
5.
J Tissue Viability ; 30(3): 317-323, 2021 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-33846059

RESUMEN

BACKGROUND: A venous leg ulcer is a chronic leg wound caused by poor venous blood circulation in the lower limbs. It is a recurring condition causing pain, malodour, reduced mobility, and depression. Randomised controlled trials evaluating treatments for venous leg ulcers provide important evidence to inform clinical decision-making. However, for findings to be useful, outcomes need to be clinically meaningful, consistently reported across trials, and fully reported. Research has identified the large number of outcomes reported in venous leg ulcer trials, impacting both synthesis of results, and clinical decision-making. To address this, a core outcome set will be developed. A core outcome set is an agreed standardised set of outcomes which should be, as a minimum, measured and reported in all trials which evaluate treatment effectiveness for a given indication. A core outcome set has the potential to reduce research waste, improve the utility of RCTs, reduce reporting bias, facilitate treatment comparisons across different sources of evidence and expedite the production of systematic reviews, meta-analyses and evidence-based clinical guidelines. AIM: The aim of this project is to develop a core outcome set for research evaluating the effectiveness of interventions for treating venous leg ulceration. METHODS: Through a scoping review of the literature on venous leg ulceration, we will firstly identify a list of candidate outcome domains (broad categories in relation to what is being measured) from randomised controlled trials and qualitative research, and outcomes (specific methods in relation to what is being measured). In two further stages, we will use the resulting lists of outcome domains and outcomes to design two online surveys. A range of stakeholders will be invited to participate in the surveys and they will be asked to indicate which outcome domains and outcomes are most important and should be considered as core in future research reports.


Asunto(s)
Protocolos Clínicos , Úlcera de la Pierna/terapia , Técnica Delphi , Humanos , Úlcera de la Pierna/fisiopatología , Encuestas y Cuestionarios , Resultado del Tratamiento
6.
Ann Vasc Surg ; 69: 163-173, 2020 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-32473308

RESUMEN

BACKGROUND: The aim of this study is to establish the initial safety of triple neuroprotection (TNP) in an acute stroke setting in patients presenting outside the window for systemic tissue plasminogen activator (tPA). METHODS: Over 12,000 patients were referred to our vascular services with carotid artery disease, of whom 832 had carotid intervention with a stroke rate of 0.72%. Of these, 25 patients presented (3%), between March 2015 and 2019, with acute dense stroke. These patients had either failed tPA or passed the recommended timing for acute stroke intervention. Fifteen (60%) had hemi-neglect with evidence of acute infarct on magnetic resonance imaging of the brain and a Rankin score of 4 or 5. Ninety-six percent had an 80-99% stenosis on the symptomatic side. Mean ABCD3-I score was 11.35. All patients underwent emergency carotid endarterectomy (CEA) with therapeutically induced hypothermia (32-34°C), targeted hypertension (systolic blood pressure 180-200 mm Hg), and brain suppression with barbiturate. RESULTS: There were no cases of myocardial infarction, death, cranial nerve injury, wound hematoma, or procedural bleeding. Mean hospital stay was 8.4 (±9.5) days. All cases had resolution of neurological symptoms, except 3 who had failed previous thrombolysis. Eighty percent had a postoperative Rankin score of 0 on discharge and 88% of patients were discharged home with 3 requiring rehabilitation. CONCLUSIONS: Positive neurological outcomes and no serious adverse events were observed using TNP during emergency CEA in patients with acute brain injury. We recommend TNP for patients who are at an increased risk of stroke perioperatively, or who have already suffered from an acute stroke beyond the recommended window of 24 hr. Certainly, the positive outcomes are not likely reproducible outside of high-volume units and patients requiring this surgery should be transferred to experienced surgeons in appropriate tertiary referral centers.


Asunto(s)
Estenosis Carotídea/cirugía , Endarterectomía Carotidea , Hipertensión , Hipotermia Inducida , Fármacos Neuroprotectores/administración & dosificación , Accidente Cerebrovascular/terapia , Tiopental/administración & dosificación , Tiempo de Tratamiento , Anciano , Anciano de 80 o más Años , Estenosis Carotídea/complicaciones , Estenosis Carotídea/diagnóstico , Bases de Datos Factuales , Urgencias Médicas , Endarterectomía Carotidea/efectos adversos , Femenino , Humanos , Hipotermia Inducida/efectos adversos , Infusiones Intravenosas , Tiempo de Internación , Masculino , Persona de Mediana Edad , Fármacos Neuroprotectores/efectos adversos , Proyectos Piloto , Estudios Retrospectivos , Factores de Riesgo , Accidente Cerebrovascular/diagnóstico , Accidente Cerebrovascular/etiología , Tiopental/efectos adversos , Factores de Tiempo , Resultado del Tratamiento
7.
Ann Vasc Surg ; 65: 261-270, 2020 May.
Artículo en Inglés | MEDLINE | ID: mdl-32007594

RESUMEN

BACKGROUND: Endovascular intervention for chronic symptomatic type B aortic dissection (CS-TBAD) induces aortic wall stress with negative hemodynamic cardiovascular consequences. CS-TBAD risks increased morbidity and mortality due to septum maturation with significant impact on false lumen modulation, and partial lumen thrombosis conveying the worst outcome. The aim of the TIGER technique is total aortic remodeling with true lumen expansion, false lumen regression and complete thrombosis, and stabilization of overall aortic diameter. METHODS: We report 5 cases of aortic dissection with a mean follow-up of 16 months (6-28 months). All had aneurysmal dilation, with 3 having acute pan aortic dissection and 2 having CS-TBAD. All were managed by sTaged HybrId sinGle lumEn Reconstruction (TIGER). Our first approach was to create one single lumen from the supraceliac, infradiaphragmatic aorta to both common iliac arteries with open surgical patching of the visceral arteries; then, we performed a TEVAR 3 months later. RESULTS: Three patients required a left subclavian artery chimney graft and one required bilateral subclavian to carotid artery transposition. No spinal drainage was required, and all patients had intraoperative transesophageal echo for wire guidance. We had no aortic rupture or retrograde type A dissection, and we experienced no renal, visceral, cardiac, pulmonary, or spinal complications. All patients, but one, went off their antihypertensive medication. All patients had normal estimated glomerular filtration rate postoperatively, and they all demonstrated accelerated aortic modulation. CONCLUSIONS: TIGER was not only effective at the semiacute stage to initiate remodeling and prevent malperfusion, it also facilitated a straightforward TEVAR at stage 2, which was made easier by avoiding visceral branch stenting. Moreover, it decreased the length of aortic segment, which was stented, thereby avoiding critical shattering, branch dislodgment, and visceral compromise; spinal ischemia; and negative cardiovascular consequences.


Asunto(s)
Aneurisma de la Aorta/cirugía , Disección Aórtica/cirugía , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Adulto , Disección Aórtica/diagnóstico por imagen , Disección Aórtica/fisiopatología , Aneurisma de la Aorta/diagnóstico por imagen , Aneurisma de la Aorta/fisiopatología , Prótesis Vascular , Implantación de Prótesis Vascular/instrumentación , Enfermedad Crónica , Procedimientos Endovasculares/instrumentación , Femenino , Hemodinámica , Humanos , Masculino , Persona de Mediana Edad , Stents , Factores de Tiempo , Resultado del Tratamiento , Remodelación Vascular
8.
J Tissue Viability ; 29(1): 7-11, 2020 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-31699492

RESUMEN

BACKGROUND: To date, research into interventions to promote wound healing has been led by scientists, clinicians, industry and academics, each with their own particular area of interest. However, the real experts in this area are the people who live with wounds and their families and heretofore their voice has not influenced or shaped the research agenda. AIM: This event aimed to seek patient and carer involvement as experts due to their lived experience in wounds through a partnership approach to identify research priorities and address a lack of patient and carer involvement in wound care research. METHODS: A roundtable discussion format guided by the Scottish Health Council Participation Toolkit Supporting Patient Focus and Public Involvement in NHS Scotland was utilised. The Guidance for Reporting Involvement of Patients and the Public 2 - Short Form (GRIPP2-SF) guided the reporting process. RESULTS: Key areas for future research were identified and included; Patients and carers prioritised the establishment of support groups and the development of educational resources. Research priorities that emerged included understanding the impact of wounds, pain management, addressing educational needs and quantifying the financial burden on patients and carers of living with a wound. CONCLUSIONS: A key conclusion from this roundtable was that patients and their carers expressed a strong interest in further wound care related public and patient involvement events and identified areas for future research.


Asunto(s)
Cuidadores , Participación de la Comunidad , Participación del Paciente , Úlcera por Presión/prevención & control , Humanos , Irlanda , Proyectos de Investigación
9.
J Vasc Surg ; 70(2): 485-496, 2019 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-30777686

RESUMEN

OBJECTIVE: Endovascular aneurysm repair (EVAR) for abdominal aortic aneurysms (AAAs) is the standard treatment for anatomically suitable patients. EVAR has been associated with a lower perioperative morbidity and mortality compared with open surgical repair (OSR) at the expense of increased reinterventions and costs. We aimed to compare the outcomes of EVAR and OSR for elective AAA repair. The primary end point was cost per QALY at 3 years. Secondary end points were perioperative morbidity and mortality; freedom from reintervention; length of hospital, high-dependency unit, and intensive care unit stay; and freedom from all-cause mortality. METHODS: The project was approved by the Galway Clinical Research Ethics Committee. This project followed the Declaration of Helsinki. This was an audit of interventions that had already taken place. No active clinical intervention was undertaken, and patients' anonymity was preserved; thus, individual patient consent was not obtained. Data on all elective AAA repairs at a tertiary referral vascular center were collected from 2002 to 2015. Demographics and outcomes were reported according to the Society for Vascular Surgery guidelines. QALY was measured on the basis of a quality-adjusted time without symptoms or toxicity assessment. Data were analyzed using parametric and nonparametric tests. RESULTS: Between 2002 and 2015, a total of 494 patients required elective AAA surgery; 401 underwent EVAR and 93 underwent OSR. Demographics and vascular-related risk factors were similar in both groups. Median (interquartile range) cost per QALY at 3 years was €5776 (€5541-€6481) for EVAR vs €7101 (€5812-€8952) for OSR (P < .001). EVAR was associated with reduced perioperative morbidity (12.2% vs 50%; P < .001). There was no significant association between procedure and perioperative mortality (EVAR, 1.7%; OSR, 4.3%; P = .130). There was no significant association found between the procedure and reintervention (P = .502). Our subgroup analysis found no association between procedure and improvement in all-cause mortality, QALYs, costs, or cost per QALY. CONCLUSIONS: EVAR is cost-effective with improved cost per QALY compared with OSR.


Asunto(s)
Aneurisma de la Aorta Abdominal/economía , Aneurisma de la Aorta Abdominal/cirugía , Implantación de Prótesis Vascular/economía , Procedimientos Endovasculares/economía , Costos de Hospital , Hospitales de Alto Volumen , 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 , Ahorro de Costo , Análisis Costo-Beneficio , Bases de Datos Factuales , Procedimientos Quirúrgicos Electivos/economía , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/mortalidad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias/economía , Complicaciones Posoperatorias/terapia , Supervivencia sin Progresión , Años de Vida Ajustados por Calidad de Vida , Retratamiento/economía , Estudios Retrospectivos , Factores de Tiempo
10.
Ann Vasc Surg ; 56: 163-174, 2019 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-30476604

RESUMEN

BACKGROUND: The objective of the study was to compare the cost-effectiveness of endovascular aortic repair (rEVAR) versus open surgical repair (rOSR) for ruptured abdominal aortic aneurysm (rAAA), where rEVAR is regularly performed outside of instructions for use (IFUs) (shorter and more angulated necks). Primary end point is incremental cost-effectiveness ratio (ICER) of rEVAR versus rOSR and aneurysm-related mortality. Secondary end points are cost per quality-adjusted life years (QALYs), perioperative morbidity and mortality, reintervention, and all-cause mortality. METHODS: All rAAA repairs performed between 2002 and 2016 in a single center were scrutinized. Between 2002 and 2007, most rAAAs were repaired using rOSR. From 2007 to 2016, we implemented a rEVAR with an anatomically possible protocol. During this time, severe angulation was rarely seen as a contraindication to rEVAR, and rEVAR was performed on aneurysms with an infrarenal aortic neck cranial to the aneurysm with a diameter of 20-33 mm and a length of at least 5 mm. Demographics and outcomes were reported according to the Society for Vascular Surgery guidelines. QALY was measured based on quality of time spent without symptoms of disease or toxicity of treatment (Q-TWiST) assessment. RESULTS: Eight hundred aneurysm surgeries were performed; of these, 135 were emergency surgeries of which 88 were for rAAA; (42 rEVARs and 46 rOSRs). Primary technical success (rEVAR 89.1% vs. rOSR 87.8%; P = 0.1), perioperative morbidity (rEVAR 56.5% vs. rOSR 64.3%; P = 0.457), and mortality (rEVAR 26.1% vs. rOSR 28.6%; P = 0.794) were nonsignificantly favorable in rEVAR patients. Freedom from reintervention was significantly lower in rEVAR patients at 3 years (rEVAR 74% vs. rOSR 90%; P = 0.038). Three-year aneurysm-related survival (rEVAR 65% vs. rOSR 62%; P = 0.848) and all-cause survival (rEVAR 56% vs. rOSR 51%; P = 0.577) were higher in rEVAR patients. At 3 years, rEVAR patients had a higher QALY of 1.671 versus OSR of 1.549 (P = 0.502). Operating room (P = 0.001) and total accommodation costs (P = 0.139) were lower in rEVAR patients, while equipment (P < 0.001), surveillance, and reintervention (P < 0.001) costs were higher. Median cost of rEVAR at 3 years was €23,352 vs. €20,494 for OSR (P < 0.084) (power>80%). Median cost per QALY of rEVAR at 3 years was €13,974 vs. €13,230 for rOSR (P = 0.296). ICER for rEVAR versus rOSR was €23,426 (95% confidence interval [CI] < €0 to > €30,000). At 3 years, the area under the curve and 95% CI for Q-TWiST was higher in rEVAR compared with OSR (rEVAR 500.819 vs. rOSR 437.838). CONCLUSIONS: There is no significant difference in cost or QALYs between rEVAR and rOSR even when rEVAR is performed on complex cases outside of IFU (shorter and more angulated necks). There is a significantly higher freedom from secondary intervention in rOSR patients compared with rEVAR patients at 3 years.


Asunto(s)
Aneurisma de la Aorta Abdominal/economía , Aneurisma de la Aorta Abdominal/cirugía , Rotura de la Aorta/economía , Rotura de la Aorta/cirugía , Implantación de Prótesis Vascular/economía , Procedimientos Endovasculares/economía , Costos de Hospital , Hospitales de Alto Volumen , Evaluación de Procesos y Resultados en Atención de Salud/economía , Anciano , Anciano de 80 o más Años , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/mortalidad , Rotura de la Aorta/diagnóstico por imagen , Rotura de la Aorta/mortalidad , Aortografía/métodos , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/mortalidad , Análisis Costo-Beneficio , Bases de Datos Factuales , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/mortalidad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias/economía , Complicaciones Posoperatorias/mortalidad , Complicaciones Posoperatorias/cirugía , Supervivencia sin Progresión , Calidad de Vida , Años de Vida Ajustados por Calidad de Vida , Reoperación/economía , Factores de Riesgo , Factores de Tiempo , Tomografía Computarizada por Rayos X , Resultado del Tratamiento
11.
Ann Vasc Surg ; 60: 254-263, 2019 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-31200032

RESUMEN

BACKGROUND: We aim to identify gender differences in complications after carotid surgery. Our primary endpoint is the incidence of perioperative stroke, myocardial infarction, and mortality. Secondary endpoints include restenosis and reintervention rates. METHODS: All patients undergoing carotid endarterectomy from July 2003 to May 2016 were reviewed. The Society for Vascular Surgery carotid reporting standards were used as a guideline for data collection. RESULTS: Over 13 years, 9,585 patients with carotid disease were referred to our institution. A total of 690 procedures were performed (633 carotid endarterectomies, 54 carotid angioplasties and stenting, and 3 bypasses). Of these 633 carotid endarterectomy procedures, 31.8% (201) were in women and 68.2% (432) were in men. In the perioperative period, female gender was found to be an independent predictor of stroke (odds ratio [OR]: 8.597, 95% confidence interval [CI]: 0.967-76.429, P = 0.041), restenosis (OR: 2.103, 95% CI: 1.445-3.060, P < 0.001), and reintervention (OR: 6.448, 95% CI: 1.313-31.667, P = 0.019). Mortality and cardiac morbidity did not significantly differ between genders. Ten-year stroke-free survival was 98.0% in women and 99.1% in men (logrank P = 0.259). Ten-year restenosis-free survival was 77.6% (45 of 201) in women and 89.4% (45 of 425) in men (logrank P < 0.001). Ten-year reintervention-free survival was 97.0% in women and 99.5% in men (logrank P = 0.008). Female gender was not an independent predictor of myocardial infarction (P = 0.713) and mortality (P = 0.856), respectively. The mean follow-up time was 47.06 ± 37.48 months with a median follow-up time of 43 months (interquartile range: 14.0-72.5). CONCLUSIONS: Female gender was an independent predictor of postoperative stroke, restenosis, and reintervention. Symptom status at the time of surgery and type of closure of the arteriotomy did not influence development of stroke in female patients.


Asunto(s)
Angioplastia/efectos adversos , Enfermedades de las Arterias Carótidas/terapia , Endarterectomía Carotidea/efectos adversos , Infarto del Miocardio/epidemiología , Accidente Cerebrovascular/epidemiología , Injerto Vascular/efectos adversos , Anciano , Anciano de 80 o más Años , Angioplastia/instrumentación , Angioplastia/mortalidad , Enfermedades de las Arterias Carótidas/diagnóstico por imagen , Enfermedades de las Arterias Carótidas/mortalidad , Endarterectomía Carotidea/mortalidad , Femenino , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Infarto del Miocardio/diagnóstico , Infarto del Miocardio/mortalidad , Supervivencia sin Progresión , Recurrencia , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Factores Sexuales , Stents , Accidente Cerebrovascular/diagnóstico , Accidente Cerebrovascular/mortalidad , Factores de Tiempo , Injerto Vascular/mortalidad
12.
Vascular ; 26(2): 142-150, 2018 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-29020882

RESUMEN

Aim We aim to compare the outcome of diabetic patients with gangrenous toes who were managed initially either by digital amputation or by transmetatarsal amputation. The null hypothesis is that transmetatarsal amputation had less theatre trips and better healing. Materials and Methods A parallel observational comparative study of all diabetic patients who underwent either digital or transmetatarsal amputation in a tertiary referral center from 2002 through 2015. Comorbid conditions, subsequent amputations, hospital stay, and readmission were noted. Results A total of 223 patients underwent minor amputation during the study period, of which 147 patients were diabetic and 76 patients were non-diabetic. Seventy-seven patients had digital amputation and 70 transmetatarsal amputation in diabetic patients. Demographics were similar in both groups. The median time to major amputation was (400 ± IQR 1205 days) in the digital amputation group, compared to 690 ± IQR 891 days in the transmetatarsal amputation group ( P = 0.974). 29.9% of digital amputations and 15.7% of transmetatarsal amputations in diabetic patients, required minor amputations or revision procedures ( P = 0.04). Median length of hospital stay was (20 days, IQR 27) in the digital group and (17 days, IQR17) in the transmetatarsal amputation group ( P = 0.17). Need for re-admission was 48.1% in digital patients compared to 50% in transmetatarsal amputation patients ( P = 0.81). Quality of time spent without symptoms of disease or toxicity of treatment (Q-TWiST) was (315 days, IQR 45) in digital group and (346 days, IQR 48) in the transmetatarsal amputation patients ( P = 0.099). Conclusion Despite the lack of statistical significance, transmetatarsal amputation offered better outcome in the diabetic patients, with less re-intervention rate, shorter hospital stays, less theatre trips, and longer time without toxicity (TWiST).


Asunto(s)
Amputación Quirúrgica/métodos , Pie Diabético/cirugía , Huesos Metatarsianos/cirugía , Calidad de Vida , Dedos del Pie/irrigación sanguínea , Anciano , Amputación Quirúrgica/efectos adversos , Pie Diabético/diagnóstico por imagen , Pie Diabético/fisiopatología , Pie Diabético/psicología , Femenino , Gangrena , Humanos , Estimación de Kaplan-Meier , Tiempo de Internación , Masculino , Persona de Mediana Edad , Readmisión del Paciente , Reoperación , Estudios Retrospectivos , Factores de Riesgo , Factores de Tiempo , Dedos del Pie/patología , Resultado del Tratamiento
13.
Vascular ; 26(6): 581-590, 2018 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-29759039

RESUMEN

OBJECTIVES: Common femoral artery endarterectomy (CFE) is the standard treatment for common femoral artery occlusive disease. We aim to assess the medium term outcomes of CFE with or without further concomitant procedures. DESIGN: A retrospective observational study. METHODS: All patients who underwent either isolated CFE (ICFE), CFE with angioplasty for occlusive arterial disease (CFEA) or concomitant CFE with endovascular aortic aneurysm repair (CFEE) were included. Patient demographics follow up, clinical improvement, types of CFE closure, patency rates, and survival-free amputation were noted. RESULTS: From 2002 to 2015, 1512 patients were referred with a diagnosis of critical limb ischemia. Of those, 1134 required revascularization. Sixty-one patients underwent 66 CFE. Ten limbs underwent an ICFE, 35 had CFEA, and 21 underwent CFEE. Demographics were comparable in all groups. Twenty-seven were closed primarily, while 39 required patch closure (12 venous, 8 Dacron, 19 biological). Technical success was 100% in ICFEs, 94% in CFEA, and 100% for CFEE ( p = 0.274). Immediate clinical success was 100% in both CFE and CFEE, but was 85.7% in CFEA ( p = 0.035). Immediate hemodynamic success was similar in all three groups ( p = 0.73). Sustained hemodynamic success was 30% in ICFE, 54.3% in CFEA, and 23.8% in CFEE ( p = 0.056). At two years, the primary patency was 90% in ICFE, 74.3% in CFEA, and 100% in CFEE ( p = 0.049). Primary-assisted patency was 90% in ICFE, 82.9% in CFEA, and 100% in CFEE ( p = 0.17). Secondary patency was 90% in ICFE, 94.3% in CFEA, and 100% in CFEE ( p = 0.409). Re-intervention was required in 26.9% of primary closures, versus 12.8% with patch closures ( p = 0.279). Amputation-free survival was 100% in ICFE, 80% in CFEA, and 100% in CFEE ( p = 0.056). CONCLUSION: CFE is a reliable and dependable procedure, even in the absence of good distal runoff.


Asunto(s)
Endarterectomía , Arteria Femoral/cirugía , Enfermedad Arterial Periférica/cirugía , Anciano , Anciano de 80 o más Años , Amputación Quirúrgica , Angioplastia , Supervivencia sin Enfermedad , Endarterectomía/efectos adversos , Femenino , Arteria Femoral/diagnóstico por imagen , Arteria Femoral/fisiopatología , Humanos , Recuperación del Miembro , Masculino , Persona de Mediana Edad , Enfermedad Arterial Periférica/diagnóstico por imagen , Enfermedad Arterial Periférica/fisiopatología , Estudios Retrospectivos , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento , Grado de Desobstrucción Vascular
16.
Vascular ; 24(4): 390-403, 2016 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-26482428

RESUMEN

INTRODUCTION: This study examines the predictive value of intensive care unit (ICU) scoring systems in a vascular ICU population. METHODS: From April 2005 to September 2011, we examined 363 consecutive ICU admissions. Simplified Acute Physiology Score II (SAPS II), Acute Physiology and Chronic Health Evaluation II (APACHE II), APACHE IV, Multiple Organ Dysfunction Score (MODS), organ dysfunctions and/or infection (ODIN), mortality prediction model (MPM) and physiologic and operative severity score for the enumeration of mortality and morbidity (POSSUM) were calculated. The Glasgow Aneurysm Score (GAS) was calculated for patients with aneurysm-related admissions. RESULTS: Overall mortality for complex vascular intervention was 11.6%. At admission, the areas under the receiver operating characteristic curve (AUCs) was 0.884 for SAPS II, 0.894 for APACHE II, 0.895 for APACHE IV, 0.902 for MODS, 0.891 for ODIN and 0.903 for MPM. At 24 h, model discrimination was best for POSSUM (AUC = 0.906) and MPM (AUC = 0.912). CONCLUSION: The good discrimination of these scoring systems indicates their value as an adjunct to clinical assessment but should not be used on an individual basis as a clinical decision-making tool.


Asunto(s)
APACHE , Aneurisma/diagnóstico , Técnicas de Apoyo para la Decisión , Unidades de Cuidados Intensivos , Puntuaciones en la Disfunción de Órganos , Admisión del Paciente , Puntuación Fisiológica Simplificada Aguda , Aneurisma/complicaciones , Aneurisma/mortalidad , Aneurisma/terapia , Área Bajo la Curva , Toma de Decisiones Clínicas , Humanos , Valor Predictivo de las Pruebas , Pronóstico , Curva ROC , Reproducibilidad de los Resultados , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Índice de Severidad de la Enfermedad
17.
Front Surg ; 11: 1361963, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38638141

RESUMEN

Background: This study evaluates the implications of blood pressure homeostasis in bilateral vs. unilateral carotid surgeries, focusing on the incidence of postoperative hypertension, hyperperfusion syndrome, and stroke as primary outcomes. It further delves into the secondary outcomes encompassing major adverse cardiovascular events and all-cause mortality. Methods: Spanning two decades (2002-2023), this comprehensive retrospective research encompasses 15,369 carotid referrals, out of which 1,230 underwent carotid interventions. A subset of 690 patients received open carotid procedures, with a 10-year follow-up, comprising 599 unilateral and 91 bilateral surgeries. The Society for Vascular Surgery Carotid Reporting Standards underpin our methodological approach for data collection. Both univariate and multivariate analyses were utilized to identify factors associated with postoperative hypertension using the Statistical Package for the Social Sciences (SPSS) Version 22 (SPSS®, IBM® Corp., Armonk, N.Y., USA). Results: A marked acute elevation in blood pressure was observed in patients undergoing both unilateral and bilateral carotid surgeries (p < 0.001). Smoking (OR: 1.183, p = 0.007), hyperfibrinogenemia (OR: 0.834, p = 0.004), emergency admission (OR: 1.192, p = 0.005), severe ipsilateral carotid stenosis (OR: 1.501, p = 0.022), and prior ipsilateral interventions (OR: 1.722, p = 0.003) emerged as significant factors that correlates with postoperative hypertension in unilateral surgeries. Conversely, in bilateral procedures, gender, emergency admissions (p = 0.012), and plaque morphology (p = 0.035) significantly influenced postoperative hypertension. Notably, 2.2% of bilateral surgery patients developed hyperperfusion syndrome, culminating in hemorrhagic stroke within 30 days. Intriguingly, postoperative stage II hypertension was identified as an independent predictor of neurological deficits post-secondary procedure in bilateral CEA cases (p = 0.004), attributable to hyperperfusion syndrome. However, it did not independently predict myocardial infarction or mortality outcomes. The overall 30-day stroke rate stood at 0.90%. Lowest incidence of post operative hypertension or any complications were observed in eversion carotid endartrertomy. Conclusion: The study identifies postoperative hypertension as a crucial independent predictor of perioperative stroke following bilateral carotid surgery. Moreover, the study elucidates the significant impact of bilateral CEA on the development of post-operative hyperperfusion syndrome or stroke, as compared to unilateral CEA. Currently almost 90% of our carotid practice is eversion carotid endartrerectomy.

18.
J Vasc Surg ; 57(4): 1038-45, 2013 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-23321343

RESUMEN

OBJECTIVE: The aim of this study was to evaluate duplex ultrasound arterial mapping (DUAM) as the sole imaging modality when planning for bypass surgery (BS) and endovascular revascularization (EvR) in patients with critical limb ischemia for TransAtlantic Inter-Society Consensus (TASC) II C/D infrainguinal lesions. METHODS: This was a retrospective review evaluating the accuracy of DUAM as the sole imaging tool in determining patient suitability for BS vs EvR. Primary outcomes were the sensitivity and specificity of DUAM compared with intraoperative digital subtraction angiography. Secondary outcomes were procedural, hemodynamic, and clinical outcomes, amputation-free survival, and freedom from major adverse clinical events. RESULTS: From 2002 to 2012, a total of 4783 patients with peripheral arterial disease were referred, of whom 622 critical limb ischemia patients underwent revascularization for TASC C and D lesions (EvR: n = 423; BS: n = 199). Seventy-four percent of EvR and 82% of BS were performed for TASC D (P = .218). The DUAM showed sensitivity of 97% and specificity of 98% in identifying lesions requiring intervention. Of the 520 procedures performed with DUAM alone, there was no difference regarding the number of procedures performed for occlusive or de novo lesions (EvR: 65% and 71%; BS: 87% and 78%; P = .056). Immediate clinical improvement to the Rutherford category ≤3 was 96% for EvR and 97% for BS (P = .78). Hemodynamic success was 79% for EvR and 77% for BS (P = .72). Six-year freedom from binary restenosis was 71.6% for EvR and 67.4% for BS (P = .724). Six-year freedom from target lesion revascularization was 81.1% for EvR and 70.3% for BS (P = .3571). Six-year sustained clinical improvement was 79.5% for EvR and 66.7% for BS (P = .294). Six-year amputation-free survival was 77.2% for EvR and 74.6% for BS (P = .837). There was a significant difference in risk of major adverse clinical events between EvR and BS (51% vs 70%; P = .034). Only 16.4% of patients required magnetic resonance angiography, which tended to overestimate lesions with 84% agreement with intraoperative findings. Six-year binary restenosis was 71% for DUAM procedures compared with 55% for magnetic resonance angiography procedures (P = .001), which was solely based on the prospective modality. CONCLUSIONS: The DUAM epitomizes a minimally invasive, economically proficient modality for road mapping procedural outcome in BS and EvR. It allows for high patient turnover with procedural and clinical success without compromising hemodynamic outcome. The DUAM is superior to other available modalities as the sole preoperative imaging tool in a successful limb salvage program.


Asunto(s)
Procedimientos Endovasculares , Isquemia/diagnóstico por imagen , Isquemia/terapia , Extremidad Inferior/irrigación sanguínea , Ultrasonografía Doppler Dúplex , Injerto Vascular , Anciano , Anciano de 80 o más Años , Amputación Quirúrgica , Angiografía de Substracción Digital , Distribución de Chi-Cuadrado , Enfermedad Crítica , Supervivencia sin Enfermedad , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/mortalidad , Femenino , Hemodinámica , Humanos , Isquemia/mortalidad , Isquemia/fisiopatología , Isquemia/cirugía , Estimación de Kaplan-Meier , Recuperación del Miembro , Angiografía por Resonancia Magnética , Masculino , Persona de Mediana Edad , Selección de Paciente , Valor Predictivo de las Pruebas , Recuperación de la Función , Reoperación , Estudios Retrospectivos , Sensibilidad y Especificidad , Factores de Tiempo , Resultado del Tratamiento , Injerto Vascular/efectos adversos , Injerto Vascular/mortalidad
19.
Prev Med Rep ; 36: 102424, 2023 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-37810263

RESUMEN

Sedentary behavior has recently emerged as a risk factor for cardiometabolic diseases. The objective of this review was to assess the relationship between sedentary behavior and peripheral arterial disease (PAD). Using the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines, we performed an electronic search across databases including Cochrane Central Register of Controlled Trials, Embase, MEDLINE (Ovid), CINHAL and PubMed to identify studies focusing on sedentary behavior and PAD. A total of 678 records fulfilled eligibility; 166 duplicates were removed, 487 were excluded at the title and abstract level and 15 studies were excluded at the full article level. Thus, our review comprised 10 studies of 20,064 patients with mean age 67.4 years. The average sedentary time was 544.9 min/day. The current review findings indicate that patients with PAD exhibited prolonged periods of sedentary behavior. Furthermore, sedentary behavior among patients with PAD was associated with lower survival rates. The included studies also reported varied outcomes regarding walking distance with some showing an association between reduced sedentary behavior and increased total walking distance. A randomized controlled trial in this review highlighted that reducing sedentary time among patients with PAD improved walking distance. Therefore, the connection between sedentary behavior and PAD seems to be bidirectional. Sedentary time could contribute to PAD development, and PAD-related symptoms may lead to prolonged sedentary behavior. A call for research investigating the link between PAD and sedentary time. Additionally, intervention studies are needed to target the reduction of sedentary time in patients with PAD.

20.
Vasc Endovascular Surg ; 57(6): 607-616, 2023 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-36891617

RESUMEN

BACKGROUND: The use of Hyperbaric Oxygen Therapy (HBOT) in diabetic wounds has been studied extensively. Even though venous insufficiency is the most common cause of lower limb ulceration, there is comparatively little evidence regarding the use of HBOT for Venous Leg Ulcers (VLU). We performed a systematic-review to evaluate and synthesise available evidence, to evaluate whether patients with VLU, when treated with HBOT, had greater rates of (i) complete VLU healing or (ii) reduction in VLU area, than controls. METHODS: In keeping with PRISMA guidelines, database searches of PubMed, Scopus and Embase was performed. After removal of duplicates, titles were screened for relevance by two authors, then abstracts, and in turn full text manuscripts. Data were extracted from relevant sources including one published abstract. Included studies were assessed for risk of bias using the Risk of Bias 2 (RoB-2) and Risk Of Bias In Nonrandomized Studies (ROBINS-I) tools. RESULTS: Six studies were included. There was significant heterogeneity across the studies, with no standard control intervention, method of outcome reporting, or duration of follow up. Two studies reported 12 week follow up results and pooled analysis of complete ulcer healing showed no statistically significant difference between HBOT and controls for the outcome of complete ulcer healing OR 1.54 (95%CI = .50-4.75) P = .4478. A similar non-signifiacnt result was seen in four studies reporting 5-6 week follow up; OR 5.39 (95%CI = .57-259.57) P = .1136. Change in VLU area was reported in all studies, and pooled standardised mean difference was 1.70 (95%CI = .60 to 2.79) P = .0024, indicating a statistically significant benefit of HBOT in reducing ulcer area. CONCLUSION: Existing evidence suggests that HBOT does not significantly affect complete healing of VLU. There is a statistically significant benefit in terms of reducing ulcer size, though in the absence of ulcer healing the clinical significance of this is not established. Current evidence does not justify widespread use of HBOT for VLU.


Asunto(s)
Oxigenoterapia Hiperbárica , Úlcera Varicosa , Humanos , Úlcera Varicosa/terapia , Úlcera Varicosa/tratamiento farmacológico , Oxigenoterapia Hiperbárica/efectos adversos , Úlcera/terapia , Resultado del Tratamiento , Cicatrización de Heridas
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