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1.
N Engl J Med ; 388(13): 1171-1180, 2023 Mar 30.
Artículo en Inglés | MEDLINE | ID: mdl-36988592

RESUMEN

BACKGROUND: Approximately 20% of patients with chronic limb-threatening ischemia have no revascularization options, leading to above-ankle amputation. Transcatheter arterialization of the deep veins is a percutaneous approach that creates an artery-to-vein connection for delivery of oxygenated blood by means of the venous system to the ischemic foot to prevent amputation. METHODS: We conducted a prospective, single-group, multicenter study to evaluate the effect of transcatheter arterialization of the deep veins in patients with nonhealing ulcers and no surgical or endovascular revascularization treatment options. The composite primary end point was amputation-free survival (defined as freedom from above-ankle amputation or death from any cause) at 6 months, as compared with a performance goal of 54%. Secondary end points included limb salvage, wound healing, and technical success of the procedure. RESULTS: We enrolled 105 patients who had chronic limb-threatening ischemia and were of a median age of 70 years (interquartile range, 38 to 89). Of the patients enrolled, 33 (31.4%) were women and 45 (42.8%) were Black, Hispanic, or Latino. Transcatheter arterialization of the deep veins was performed successfully in 104 patients (99.0%). At 6 months, 66.1% of the patients had amputation-free survival. According to Bayesian analysis, the posterior probability that amputation-free survival at 6 months exceeded a performance goal of 54% was 0.993, which exceeded the prespecified threshold of 0.977. Limb salvage (avoidance of above-ankle amputation) was attained in 67 patients (76.0% by Kaplan-Meier analysis). Wounds were completely healed in 16 of 63 patients (25%) and were in the process of healing in 32 of 63 patients (51%). No unanticipated device-related adverse events were reported. CONCLUSIONS: We found that transcatheter arterialization of the deep veins was safe and could be performed successfully in patients with chronic limb-threatening ischemia and no conventional surgical or endovascular revascularization treatment options. (Funded by LimFlow; PROMISE II study ClinicalTrials.gov number, NCT03970538.).


Asunto(s)
Amputación Quirúrgica , Derivación Arteriovenosa Quirúrgica , Isquemia Crónica que Amenaza las Extremidades , Procedimientos Endovasculares , Anciano , Femenino , Humanos , Masculino , Teorema de Bayes , Isquemia Crónica que Amenaza las Extremidades/mortalidad , Isquemia Crónica que Amenaza las Extremidades/cirugía , Procedimientos Endovasculares/métodos , Procedimientos Endovasculares/mortalidad , Isquemia/mortalidad , Isquemia/cirugía , Recuperación del Miembro/métodos , Recuperación del Miembro/mortalidad , Enfermedad Arterial Periférica/mortalidad , Enfermedad Arterial Periférica/cirugía , Estudios Prospectivos , Factores de Riesgo , Resultado del Tratamiento , Amputación Quirúrgica/métodos , Amputación Quirúrgica/mortalidad , Úlcera de la Pierna/fisiopatología , Úlcera de la Pierna/cirugía , Úlcera de la Pierna/terapia , Cateterismo , Derivación Arteriovenosa Quirúrgica/métodos , Cicatrización de Heridas , Adulto , Persona de Mediana Edad , Anciano de 80 o más Años , Pierna/irrigación sanguínea , Pierna/cirugía , Arterias/cirugía , Venas/cirugía
2.
Eur J Vasc Endovasc Surg ; 67(4): 644-652, 2024 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-37981003

RESUMEN

OBJECTIVE: To compare thrombus removal and residual venous symptoms and signs of disease following interventional treatment of iliofemoral deep vein thrombosis (DVT) with mechanical thrombectomy (MT) and pharmacomechanical catheter directed thrombolysis (PCDT). METHODS: Retrospective cohort analysis of propensity score matched subgroups from the multicentre prospective MT ClotTriever Outcomes registry and the PCDT arm of the randomised Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter Directed Thrombolysis trial. Patients with bilateral DVT, symptom duration greater than four weeks, isolated femoral-popliteal disease, or incomplete case data were excluded. Patients with iliofemoral DVT were propensity score matched (1:1) on 10 baseline covariables, including race, sex, age, body mass index, leg treated, prior thromboembolism, Marder score, symptom duration, provoked deep vein thrombosis status, and Villalta score. Reduction in post-procedure thrombus burden (i.e., Marder scores), assessment of venous symptoms and signs (i.e., Villalta scores) at 12 months, and healthcare resource utilisation were compared between subgroups. RESULTS: Propensity score matching resulted in 130 patient pairs with no significant differences in baseline characteristics between the MT and PCDT groups. MT was associated with a greater reduction in Marder scores (91.0% vs. 67.7%, p < .001), and a greater proportion of patients at 12 months with no post-thrombotic syndrome (83.1% vs. 63.6%, p = .007) compared with matched patients receiving PCDT. No differences in rates of adjunctive stenting or venoplasty were identified (p = .27). Higher rates of single session treatment were seen with MT (97.7% vs. 26.9%, p < .001), which also showed shorter mean post-procedure hospital stays (1.81 vs. 3.46 overnights, p < .001), and less post-procedure intensive care unit utilisation (2.3% vs. 52.8%, p < .001). CONCLUSION: Compared with PCDT, MT was associated with greater peri-procedural thrombus reduction, more efficient post-procedure care, and improved symptoms and signs of iliofemoral vein disease at 12 months.


Asunto(s)
Síndrome Postrombótico , Trombosis de la Vena , Humanos , Terapia Trombolítica/efectos adversos , Fibrinolíticos , Estudios Retrospectivos , Puntaje de Propensión , Estudios Prospectivos , Vena Femoral/diagnóstico por imagen , Resultado del Tratamiento , Vena Ilíaca/diagnóstico por imagen , Trombosis de la Vena/diagnóstico por imagen , Trombosis de la Vena/terapia , Síndrome Postrombótico/etiología , Catéteres , Trombectomía/efectos adversos
3.
Vasc Med ; 29(1): 26-35, 2024 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-38084862

RESUMEN

BACKGROUND: Systemic thrombolysis (ST) is the guideline-recommended treatment for high-risk pulmonary embolism (PE), although catheter-directed thrombolysis (CDT) may provide a treatment alternative associated with lower rates of bleeding. Furthermore, the treatment trends and outcomes among those with high-risk PE according to treatment assignments of no lytic therapy (NLT), ST, and CDT are underreported. METHODS: Patients hospitalized for high-risk PE between 2016 and 2019 were identified by administrative claims codes from the National Readmission Database. Therapy assignment was similarly defined by administrative codes, then stratified into NLT, ST, and CDT cohorts to report patient characteristics, care settings, and clinical outcomes. The primary outcome was in-hospital mortality with rates adjusted for patient and hospital characteristics using multivariable logistic regression. Secondary outcomes included intracranial hemorrhage (ICH), gastrointestinal bleeding (GIB), and 90-day readmission. Over the years of interest, trends in lytic treatment along with concomitant use of mechanical or surgical thrombectomy were reported. RESULTS: Among 74,516 patients with high-risk PE, 61,569 (82.6%) received NLT, 8445 (11.3%) received ST, and 4502 (6.04%) received CDT. The NLT subgroup, relative to ST and CDT, tended to be older (66.1 ± 15.4, 62.8 ± 15.3, and 63.4 ± 14.4; p < 0.001) and more frequently women (56.0%, 54.4%, and 51.3%; p < 0.001), respectively. The unadjusted in-hospital mortality rate was highest for ST (18.8%, 34.1%, and 18.3% for NLT, ST, and CDT, respectively; p < 0.001) and persisted after multivariable adjustment (adjusted odds ratio (aOR) 0.43; 95% CI 0.38-0.49; p < 0.0001) of in-hospital mortality for CDT relative to ST. The unadjusted rate of ICH or GIB was lowest for NLT (1.0%, 2.0%, and 0.6% for NLT, ST, and CDT, respectively; p < 0.001). CDT, relative to ST, was associated with reduced odds of ICH (aOR 0.32; 95% CI 0.18-0.55; p < 0.0001) and GIB (aOR 0.78; 95% CI 0.62-0.98; p < 0.0001). Readmissions were highest for NLT (21.7%, 9.6%, and 12.1% for NLT, ST, and CDT, respectively; p < 0.001). CDT was associated with a higher incidence of 90-day readmission relative to ST (aOR 1.32; 95% CI 1.10-1.57; p < 0.001). From 2016 to 2019, individual treatment trends were not significantly different, although NLT tended to be offered among smaller and rural hospitals. Rates of concomitant thrombectomy were low in all three treatment groups. CONCLUSIONS: Among a large, contemporary, US cohort with high-risk PE, over 80% of patients did not receive any form of thrombolysis. High-risk PE that did receive systemic thrombolysis was associated with the highest rates of in-hospital mortality, suggesting opportunities to study the implementation of lytic and nonlytic-based treatments to improve outcomes for those presenting with high-risk PE.


Asunto(s)
Fibrinolíticos , Embolia Pulmonar , Humanos , Femenino , Fibrinolíticos/uso terapéutico , Terapia Trombolítica/efectos adversos , Resultado del Tratamiento , Hemorragia Gastrointestinal/inducido químicamente , Estudios Retrospectivos
4.
J Vasc Interv Radiol ; 34(5): 879-887.e4, 2023 05.
Artículo en Inglés | MEDLINE | ID: mdl-37105663

RESUMEN

PURPOSE: To analyze the first 250 patients from the prospective, multicenter, industry-sponsored ClotTriever Outcomes (CLOUT) registry, assessing the safety and effectiveness of mechanical thrombectomy for acute, subacute, and chronic deep vein thrombosis (DVT). MATERIALS AND METHODS: Real-world patients with lower extremity DVT were treated with the ClotTriever System (Inari Medical, Irvine, California). Adjuvant venoplasty, stent placement, or both were performed at the physician's discretion. Thrombus chronicity was determined by visual inspection of removed thrombus, categorizing patients into acute, subacute, and chronic subgroups. Serious adverse events (SAEs) were assessed through 30 days. Clinical and quality-of-life (QoL) outcomes are reported through 6 months. RESULTS: Thrombus chronicity was designated for 244 of the 250 patients (acute, 32.8%; subacute, 34.8%; chronic, 32.4%) encompassing 254 treated limbs. Complete or near-complete (≥75%) thrombus removal was achieved in 90.8%, 81.9%, and 83.8% of the limbs with acute, subacute, and chronic thrombus, respectively. No fibrinolytics were administered, and 243 (99.6%) procedures were single sessions. One (0.4%) patient in the subacute group experienced a device-related SAE, a fatal pulmonary embolism. On comparing baseline and 6-month data, improvements were demonstrated in median Villalta scores (acute, from 10 to 1; subacute, from 9 to 1; chronic, from 10 to 3; for all, P < .0001) and mean EuroQol group 5-dimension (EQ-5D) self-report questionnaire scores (acute, 0.58 to 0.89; subacute, 0.65 to 0.87; chronic, 0.58 to 0.88; for all, P < .0001). There were no significant differences in outcomes across the subgroups. CONCLUSIONS: Mechanical thrombectomy using the ClotTriever System with adjunctive venoplasty and stent placement is safe and similarly effective for acute, subacute, and chronic DVT.


Asunto(s)
Trombectomía , Trombosis de la Vena , Humanos , Trombectomía/efectos adversos , Resultado del Tratamiento , Estudios Prospectivos , Calidad de Vida , Terapia Trombolítica , Trombosis de la Vena/diagnóstico por imagen , Trombosis de la Vena/terapia , Trombosis de la Vena/etiología , Sistema de Registros , Vena Ilíaca , Estudios Retrospectivos
5.
J Nucl Cardiol ; 30(6): 2666-2675, 2023 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-37524997

RESUMEN

BACKGROUND: Peripheral artery disease (PAD) and coronary vascular dysfunction are common in patients with cardiometabolic disease. Neither the prevalence of coronary vascular dysfunction among patients with PAD nor the prognostic impact with these two conditions present together has been well studied. METHODS: Consecutive patients who underwent PET MPI were analyzed for presence of coronary vascular dysfunction [myocardial blood flow reserve (MBFR) < 2]. Cox regression was used to examine the association of reduced MBFR with mortality in patients with PAD, as well as the association of comorbid MBFR < 2 and PAD with all-cause death. RESULTS: Among 13,940 patients, 1936 (14%) had PAD, 7782 (56%) had MBFR < 2 and 1346 (10%) had both PAD and MBFR < 2. Reduced MBFR was very common (69.5%) and was associated with increased risk of all-cause death (HR 1.69, 95%CI 1.32, 2.16, p < 0.01) in patients with PAD. Patients with both PAD and MBFR < 2, and those with either PAD or reduced MBFR had increased risk of death compared to those with neither condition: PAD + MBFR < 2 [(HR 95%CI), 2.30; 1.97-2.68], PAD + MBFR ≥ 2 (1.37; (1.08-1.72), PAD - MBFR < 2 (1.98; 1.75-2.25), p < 0.001 for all). CONCLUSION: Coronary vascular dysfunction was common in patients with PAD and was associated with increased risk of death.


Asunto(s)
Enfermedad de la Arteria Coronaria , Enfermedad Arterial Periférica , Humanos , Vasos Coronarios , Enfermedad Arterial Periférica/diagnóstico por imagen , Miocardio , Pronóstico , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Factores de Riesgo
6.
Catheter Cardiovasc Interv ; 99(4): 1345-1355, 2022 03.
Artículo en Inglés | MEDLINE | ID: mdl-35114059

RESUMEN

OBJECTIVES: The FlowTriever All-Comer Registry for Patient Safety and Hemodynamics (FLASH) is a prospective multi-center registry evaluating the safety and effectiveness of percutaneous mechanical thrombectomy for treatment of pulmonary embolism (PE) in a real-world patient population (NCT03761173). This interim analysis reports outcomes for the first 250 patients enrolled in FLASH. BACKGROUND: High- and intermediate-risk PEs are characterized by high mortality rates, frequent readmissions, and long-term sequelae. Mechanical thrombectomy is emerging as a front-line therapy for PE that enables immediate thrombus reduction while avoiding the bleeding risks inherent with thrombolytics. METHODS: The primary endpoint is a composite of major adverse events (MAE) including device-related death, major bleeding, and intraprocedural device- or procedure-related adverse events at 48 h. Secondary endpoints include on-table changes in hemodynamics and longer-term measures including dyspnea, heart rate, and cardiac function. RESULTS: Patients were predominantly intermediate-risk per ESC guidelines (6.8% high-risk, 93.2% intermediate-risk). There were three MAEs (1.2%), all of which were major bleeds that resolved without sequelae, with no device-related injuries, clinical deteriorations, or deaths at 48 h. All-cause mortality was 0.4% at 30 days, with a single death that was unrelated to PE. Significant on-table improvements in hemodynamics were noted, including an average reduction in mean pulmonary artery pressure of 7.1 mmHg (22.2%, p < 0.001). Patient symptoms and cardiac function improved through follow-up. CONCLUSIONS: These interim results provide preliminary evidence of excellent safety in a real-world PE population. Reported outcomes suggest that mechanical thrombectomy can result in immediate hemodynamic improvements, symptom reduction, and cardiac function recovery.


Asunto(s)
Embolia Pulmonar , Trombectomía , Hemorragia/etiología , Humanos , Estudios Prospectivos , Embolia Pulmonar/terapia , Sistema de Registros , Trombectomía/efectos adversos , Trombectomía/métodos , Resultado del Tratamiento
7.
Vasc Med ; 27(4): 350-357, 2022 08.
Artículo en Inglés | MEDLINE | ID: mdl-35603755

RESUMEN

Introduction: Patients with critical limb ischemia (CLI) can undergo endovascular peripheral vascular intervention (PVI) to restore blood flow and decrease risk of amputation. As a potential indicator of quality for CLI care, we sought to describe 30-day major amputation rates following PVI. We also examined rate variability, and patient-level and site-level factors predicting amputations, using a national electronic health record (EHR) database. Methods: Using the Cerner Health Facts de-identified EHR database, patients with CLI diagnosis codes undergoing PVI were identified. The rate of amputation within 30 days of PVI was calculated. Risk ratios predicting amputation were derived using a mixed effects Poisson regression model adjusting for 16 patient and clinical factors. Median risk ratios (MRRs) were calculated to quantify site-level variability in amputations. Results: A total of 20,204 PVI procedures for CLI from 179 healthcare sites were identified. Mean age at procedure was 69.0 ± 12.6 years, 58.0% were male, and 29.6% were persons of color. Amputation within 30 days of PVI occurred after 570 (2.8%) procedures. Malnutrition, previous amputation, diabetes, and being of Black race were predictors of amputation. Amputation rates across sites ranged from 0.0% to 10.0%. The unadjusted MRR was 1.40 (95% CI 1.35-1.46), which was attenuated after adjusting for patient-level factors (MRR 1.30, 95% CI 1.26-1.34) and site characteristics (MRR 1.11, 95% CI 1.09-1.13). Conclusions: Among PVI procedures for CLI treatment, 30-day amputation rates varied across institutions. Although patient-level factors explained some variability, site-level factors explained most variation in the rates of these outcomes.


Asunto(s)
Procedimientos Endovasculares , Enfermedad Arterial Periférica , Amputación Quirúrgica , Isquemia Crónica que Amenaza las Extremidades , Enfermedad Crítica , Procedimientos Endovasculares/efectos adversos , Femenino , Humanos , Isquemia/diagnóstico , Isquemia/cirugía , Recuperación del Miembro , Masculino , Enfermedad Arterial Periférica/diagnóstico , Enfermedad Arterial Periférica/cirugía , Estudios Retrospectivos , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento
8.
Vasc Med ; 26(1): 28-37, 2021 02.
Artículo en Inglés | MEDLINE | ID: mdl-33227228

RESUMEN

Limited data exist that comprehensively describe the practical management, in-hospital outcomes, healthcare resource utilization, and rates of post-hospital readmission among patients with submassive and massive pulmonary embolism (PE). Consecutive discharges for acute PE were identified from a single health system over 3 years. Records were audited to confirm presence of acute PE, patient characteristics, disease severity, medical treatment, and PE-related invasive therapies. Rates of in-hospital major bleeding and death, hospital length of stay (LOS), direct costs, and hospital readmission are reported. From January 2016 to December 2018, 371 patients were hospitalized for acute massive or submassive PE. In-hospital major bleeding (12.1%) was common, despite low utilization of systemic thrombolysis (1.8%) or catheter-directed thrombolysis (3.0%). In-hospital death was 10-fold higher among massive PE compared to submassive PE (36.6% vs 3.3%, p < 0.001). Massive PE was more common during hospitalizations not primarily related to venous thromboembolism, including hospitalizations primarily for sepsis or infection (26.8% vs 8.2%, p = 0.001). Overall, the median LOS was 6.0 days (IQR, 3.0-11.0) and the median standardized direct cost of admissions was $10,032 (IQR, $4467-$20,330). Rates of all-cause readmission were relatively high throughout late follow-up but did not differ between PE subgroups. Despite low utilization of thrombolysis, in-hospital bleeding remains a common adverse event during hospitalizations for acute PE. Although massive PE is associated with high risk for in-hospital bleeding and death, those successfully discharged after a massive PE demonstrate similar rates of readmission compared to submassive PE into late follow-up.


Asunto(s)
Embolia Pulmonar , Terapia Trombolítica , Enfermedad Aguda , Fibrinolíticos/efectos adversos , Hemorragia/tratamiento farmacológico , Mortalidad Hospitalaria , Hospitalización , Humanos , Embolia Pulmonar/tratamiento farmacológico , Embolia Pulmonar/terapia , Respiración , Estudios Retrospectivos , Terapia Trombolítica/efectos adversos , Resultado del Tratamiento
9.
Circulation ; 140(12): e657-e672, 2019 09 17.
Artículo en Inglés | MEDLINE | ID: mdl-31401843

RESUMEN

There are >12 million patients with peripheral artery disease in the United States. The most severe form of peripheral artery disease is critical limb ischemia (CLI). The diagnosis and management of CLI is often challenging. Ethnic differences in comorbidities and presentation of CLI exist. Compared with white patients, black and Hispanic patients have higher prevalence rates of diabetes mellitus and chronic renal disease and are more likely to present with gangrene, whereas white patients are more likely to present with ulcers and rest pain. A thorough evaluation of limb perfusion is important in the diagnosis of CLI because it can not only enable timely diagnosis but also reduce unnecessary invasive procedures in patients with adequate blood flow or among those with other causes for ulcers, including venous, neuropathic, or pressure changes. This scientific statement discusses the current tests and technologies for noninvasive assessment of limb perfusion, including the ankle-brachial index, toe-brachial index, and other perfusion technologies. In addition, limitations of the current technologies along with opportunities for improvement, research, and reducing disparities in health care for patients with CLI are discussed.


Asunto(s)
Extremidades/patología , Isquemia/diagnóstico , Enfermedad Arterial Periférica/diagnóstico , American Heart Association , Índice Tobillo Braquial , Equipos y Suministros , Etnicidad , Medicina Basada en la Evidencia , Extremidades/irrigación sanguínea , Disparidades en Atención de Salud , Humanos , Isquemia/epidemiología , Enfermedad Arterial Periférica/epidemiología , Flujo Sanguíneo Regional , Estados Unidos/epidemiología
10.
Catheter Cardiovasc Interv ; 92(1): 106-114, 2018 07.
Artículo en Inglés | MEDLINE | ID: mdl-29521013

RESUMEN

OBJECTIVES: To evaluate the clinical and health status outcomes of patients undergoing superficial femoral artery (SFA) revascularization using the Shape Memory Alloy Recoverable Technology (S.M.A.R.T.®) nitinol self-expanding stent through 3 years of follow-up. BACKGROUND: Limited long-term data are available describing the durability of benefits after femoropopliteal revascularization. METHODS: In a multicenter, prospective, core-lab adjudicated study, 250 subjects with de novo or restenotic femoropopliteal arterial lesions were treated with the S.M.A.R.T.® stent. The primary endpoint of target vessel patency, a composite of ultrasound-assessed patency and freedom from clinically driven target lesion revascularization (TLR), was evaluated through 3 years. Secondary endpoints included stent fracture and health status. Health status was measured using generic and disease-specific instruments, including the Peripheral Artery Questionnaire (PAQ). RESULTS: At 3-year follow-up, Kaplan-Meier estimated target vessel patency was 72.7%, freedom from clinically driven TLR was 78.5%, and the incidence of stent fracture was 3.6%. The PAQ summary score was markedly impaired at baseline (mean 37.3 ± 19.6 points) and improved substantially at 1 month (mean change from baseline of 31.4 points, 95% CI: 28.5-34.3; P < 0.001). Disease-specific health status benefits assessed by the PAQ were largely preserved through 3 years of follow-up (mean change from baseline, 28.0 points, 95% CI: 24.3-31.7; P < 0.0001). CONCLUSIONS: In patients undergoing revascularization for moderately complex SFA disease, use of the self-expanding S.M.A.R.T® stent was associated with a high rate of target vessel patency through 3 years and led to substantial and sustained health status benefits.


Asunto(s)
Procedimientos Endovasculares/instrumentación , Arteria Femoral/cirugía , Enfermedad Arterial Periférica/cirugía , Arteria Poplítea/cirugía , Calidad de Vida , Stents Metálicos Autoexpandibles , Anciano , Aleaciones , Constricción Patológica , Procedimientos Endovasculares/efectos adversos , Femenino , Arteria Femoral/diagnóstico por imagen , Arteria Femoral/fisiopatología , Estado de Salud , Humanos , Masculino , Persona de Mediana Edad , Enfermedad Arterial Periférica/diagnóstico por imagen , Enfermedad Arterial Periférica/fisiopatología , Enfermedad Arterial Periférica/psicología , Arteria Poplítea/diagnóstico por imagen , Arteria Poplítea/fisiopatología , Supervivencia sin Progresión , Estudios Prospectivos , Diseño de Prótesis , Falla de Prótesis , Encuestas y Cuestionarios , Factores de Tiempo , Ultrasonografía Intervencional , Estados Unidos , Grado de Desobstrucción Vascular
14.
Catheter Cardiovasc Interv ; 87(6): 1149-55, 2016 May.
Artículo en Inglés | MEDLINE | ID: mdl-26892836

RESUMEN

OBJECTIVES: To explore the association of health status change and long-term survival among patients with symptomatic peripheral artery disease (PAD). BACKGROUND: Early gains in health status after successful endovascular therapy (EVT) for symptomatic PAD can be maintained up to 1 year. Whether such health status improvements are associated with long-term survival benefits is unknown. METHODS: Between February 2001 and August 2004, 258 patients with symptomatic PAD treated with EVT participated in a prospective study evaluating baseline and 1 year health status using the Peripheral Artery Questionnaire (range 0-100, higher scores = better). All-cause mortality was assessed for all patients at a median of 9.4 years following EVT. RESULTS: The mean age at enrollment was 68 ± 11 years; 61% were male, 97% were Caucasian, and 38% had diabetes. Patients with a clinically meaningful health status improvement (≥8 points) 1 year after their index procedure (79%) were identified as responders. Responders had a significantly better 10 year survival compared with nonresponders (60% vs 38%, p = 0.025). Responder status was associated with a survival advantage that persisted in risk-adjusted analysis (adjusted hazard ratio for long-term mortality, 0.66 [95% CI, 0.45-0.97]; p = 0.036). CONCLUSIONS: Among patients with symptomatic PAD undergoing EVT, improvement of PAD-specific health status at 1 year follow-up was associated with improved long-term survival. Whether additional treatment for patients with poor response to EVT could improve long-term survival warrants further investigation. © 2016 Wiley Periodicals, Inc.


Asunto(s)
Procedimientos Endovasculares/métodos , Estado de Salud , Enfermedad Arterial Periférica/cirugía , Anciano , Causas de Muerte/tendencias , Femenino , Estudios de Seguimiento , Humanos , Masculino , Enfermedad Arterial Periférica/mortalidad , Periodo Posoperatorio , Estudios Prospectivos , Factores de Riesgo , Tasa de Supervivencia/tendencias , Factores de Tiempo , Estados Unidos/epidemiología
16.
Vasc Med ; 20(1): 23-9, 2015 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-25630991

RESUMEN

The relationship between ankle-brachial index (ABI) remains uncertain relative to clinical and angiographic features of critical limb ischemia (CLI). From July 2011 to February 2013, 89 consecutive patients with CLI had non-invasive testing for indications of rest pain (n=23, 26%), as well as minor (n=29, 33%) and major (n=37, 42%) ischemic tissue loss. All patients subsequently underwent ABI testing and lower extremity angiography with visualization of the infragenicular arteries. Toe-brachial index (TBI) testing was available among 31 of these patients. Among patients with any ischemic tissue loss, 29% had an ABI between 0.7 and 1.4. Patients with rest pain alone had reduced odds of abnormal arterial runoff in univariate (OR 0.75, 95% CI 0.63-0.90; p=0.002) but not multivariate (p=0.50) analysis. Advanced age, increased ABI, reduced creatinine clearance, hyperlipidemia, and prior coronary artery disease were predictive of abnormal infragenicular runoff. Despite limitations in statistical power, median TBI, compared to ABI, tended to increase when infragenicular arterial runoff was preserved. Overall, the association of TBI with abnormal runoff was not significant (p=0.38). In conclusion, in the evaluation of CLI, nearly one-third of patients with any ischemic tissue loss had a normal or mildly reduced ABI. Assessment of TBI may augment the diagnostic accuracy of ABI in the evaluation of CLI.


Asunto(s)
Índice Tobillo Braquial , Isquemia/diagnóstico , Extremidad Inferior/irrigación sanguínea , Enfermedad Arterial Periférica/diagnóstico , Grado de Desobstrucción Vascular , Anciano , Femenino , Humanos , Isquemia/fisiopatología , Modelos Logísticos , Masculino , Persona de Mediana Edad , Análisis Multivariante , Oportunidad Relativa , Enfermedad Arterial Periférica/fisiopatología , Valor Predictivo de las Pruebas , Flujo Sanguíneo Regional , Reproducibilidad de los Resultados , Estudios Retrospectivos
17.
Am J Cardiol ; 2024 Jun 11.
Artículo en Inglés | MEDLINE | ID: mdl-38871160

RESUMEN

This analysis aimed to estimate 30-day episode care costs associated with 3 contemporary endovascular therapies indicated for treatment of pulmonary embolism (PE). Systematic literature review was used to identify clinical research reporting costs associated with invasive PE care and outcomes for ultrasound-accelerated thrombolysis (USAT), continuous-aspiration mechanical thrombectomy (CAMT), and volume-controlled-aspiration mechanical thrombectomy (VAMT). Total episode variable care costs were defined as the sum of device costs, variable acute care costs, and contingent costs. Variable acute care costs were estimated using methodology sensitive to periprocedural and postprocedural resource allocation unique to the 3 therapies. Contingent costs included expenses for thrombolytics, postprocedure bleeding events, and readmissions through 30 days. Through February 28, 2023, 70 sources were identified and used to inform estimates of 30-day total episode variable costs. Device costs for USAT, CAMT, and VAMT were the most expensive single component of total episode variable costs, estimated at $5,965, $10,279, and $11,901, respectively. Costs associated with catheterization suite utilization, intensive care, and hospital length of stay, along with contingent costs, were important drivers of total episode costs. Total episode variable care costs through 30 days were $19,146, $20,938, and $17,290 for USAT, CAMT, and VAMT, respectively. In conclusion, estimated total episode care costs after invasive treatment for PE are heavily influenced by device expense, in-hospital care, and postacute care complications. Regardless of device cost, strategies that avoid thrombolytics, reduce the need for intensive care unit care, shorten length of stay, and reduce postprocedure bleeding and 30-day readmissions contributed to the lowest episode costs.

18.
J Vasc Surg Venous Lymphat Disord ; 12(4): 101825, 2024 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-38278173

RESUMEN

OBJECTIVE: To compare the comparative effects of treatment with contemporary mechanical thrombectomy (MT) or anticoagulation (AC) on Villalta scores and post-thrombotic syndrome (PTS) incidence through 12 months in iliofemoral deep vein thrombosis (DVT). METHODS: Patients with DVT in the Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (ATTRACT) randomized trial and the ClotTriever Outcomes (CLOUT) registry were included in this analysis. Both studies evaluated the effects of thrombus removal on the incidence of PTS. Patients with bilateral DVT, isolated femoral-popliteal DVT, symptom duration of >4 weeks, or incomplete case data for matching covariates were excluded. Propensity scores were used to match patients 1:1 who received AC (from ATTRACT) with those treated with mechanical thrombectomy (from CLOUT) using nearest neighbor matching on nine baseline covariates, including age, body mass index, leg treated, provoked DVT, prior venous thromboembolism, race, sex, Villalta score, and symptom duration. Clinical outcomes, including Villalta score and PTS, were assessed. Logistic regression was used to estimate the likelihood of developing PTS at 12 months. RESULTS: A total of 164 pairs were matched, with no significant differences in baseline characteristics after matching. There were fewer patients with any PTS at 6 months (19% vs 46%; P < .001) and 12 months (17% vs 38%; P < .001) in the MT treatment group. Modeling revealed that, after adjusting for baseline Villalta scores, patients treated with AC had significantly higher odds of developing any PTS (odds ratio, 3.1; 95% confidence interval, 1.5-6.2; P = .002) or moderate to severe PTS (odds ratio, 3.1; 95% confidence interval, 1.1-8.4; P = .027) at 12 months compared with those treated with MT. Mean Villalta scores were lower through 12 months among those receiving MT vs AC (3.3 vs 6.3 at 30 days, 2.5 vs 5.5 at 6 months, and 2.6 vs 4.9 at 12 months; P < .001 for all). CONCLUSIONS: MT treatment of iliofemoral DVT was associated with significantly lower Villalta scores and a lower incidence of PTS through 12 months compared with treatment using AC. Results from currently enrolling clinical trials will further clarify the role of these therapies in the prevention of PTS after an acute DVT event.


Asunto(s)
Anticoagulantes , Vena Femoral , Vena Ilíaca , Síndrome Postrombótico , Trombectomía , Trombosis de la Vena , Humanos , Trombosis de la Vena/diagnóstico por imagen , Trombosis de la Vena/terapia , Femenino , Masculino , Persona de Mediana Edad , Vena Femoral/diagnóstico por imagen , Vena Femoral/cirugía , Vena Ilíaca/diagnóstico por imagen , Vena Ilíaca/fisiopatología , Síndrome Postrombótico/diagnóstico por imagen , Síndrome Postrombótico/etiología , Síndrome Postrombótico/terapia , Anticoagulantes/uso terapéutico , Anticoagulantes/administración & dosificación , Resultado del Tratamiento , Trombectomía/efectos adversos , Factores de Tiempo , Anciano , Factores de Riesgo , Sistema de Registros , Adulto , Incidencia , Modelos Logísticos , Puntaje de Propensión , Terapia Trombolítica/efectos adversos
20.
Curr Cardiol Rep ; 15(6): 363, 2013 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-23605465

RESUMEN

The primary goals of treatment for critical limb ischemia (CLI) are alleviation of ischemic rest pain, healing of arterial insufficiency ulcers, and improving quality of life. These goals are directed toward preventing limb loss and CLI-related mortality. Arterial revascularization serves as the foundation of a contemporary approach to promote amputation-free survival. Mounting evidence supports a wound-directed angiosome revascularization approach, increasingly achieved with endovascular techniques. Innovations in technology and wound-perfusion strategy have advanced patient care and are accelerating the pace of CLI treatment. The evolving angiosome revascularization approach has been augmented with a multidisciplinary wound care strategy that deserves particular emphasis. These state-of-the-art advances in CLI management are reported herein with considerations for the future treatment of CLI.


Asunto(s)
Angioplastia/métodos , Arteriopatías Oclusivas/terapia , Isquemia/terapia , Recuperación del Miembro/métodos , Extremidad Inferior/patología , Perfusión/métodos , Arteria Poplítea/patología , Amputación Quirúrgica , Arteriopatías Oclusivas/complicaciones , Arteriopatías Oclusivas/patología , Supervivencia sin Enfermedad , Femenino , Humanos , Isquemia/etiología , Isquemia/patología , Masculino , Factores de Riesgo , Resultado del Tratamiento , Cicatrización de Heridas
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