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1.
J Vasc Access ; 21(1): 19-25, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31081441

RESUMO

Quality improvement initiatives should be aimed to enhance clinical outcomes, service delivery and quality of life for patients. For patients reliant on haemodialysis, vascular access is a lifeline. Survival differences relating to the type of vascular access are evident and many initiatives have focussed on increasing absolute rates of arteriovenous fistulas and/or decreasing central venous catheter use. While these have achieved some success quantitatively, the qualitative effects are less obvious. The aims of this review article are to explore the concepts of quality of care in vascular access. There is a paucity of studies into the effects of vascular access on the quality of life of dialysis patients, and where studies have been performed, generalised patient-reported outcome measures have been used. To facilitate the implementation of quality improvement programmes specifically for vascular access requires suitable tools. While existing patient-reported outcome measures may be applicable to vascular access, it is likely that these will require further evaluation, and the development of vascular access-specific patient-reported outcome measures may be required.


Assuntos
Derivação Arteriovenosa Cirúrgica/normas , Implante de Prótese Vascular/normas , Cateterismo Venoso Central/normas , Medidas de Resultados Relatados pelo Paciente , Melhoria de Qualidade/normas , Indicadores de Qualidade em Assistência à Saúde/normas , Diálise Renal/normas , Derivação Arteriovenosa Cirúrgica/efeitos adversos , Implante de Prótese Vascular/efeitos adversos , Cateterismo Venoso Central/efeitos adversos , Humanos , Satisfação do Paciente , Qualidade de Vida , Resultado do Tratamento
2.
Semin Thorac Cardiovasc Surg ; 31(4): 674-678, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31271851
4.
Ann Vasc Surg ; 59: 54-62, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-30802590

RESUMO

BACKGROUND: The goals of this study were to evaluate mid-term outcome in endovascular aortic repair (EVAR) of abdominal aortic aneurysm (AAA) using a GORE C3 EXCLUDER and compare results between patients treated within and outside the instructions for use (IFU). METHODS: Over a 3-year period spanning October 2013 to September 2016, consecutive patients undergoing EVAR for AAA using the C3 EXCLUDER at Tokyo Medical University Hospital were registered on a prospectively maintained database. The data thus obtained were retrospectively analyzed. RESULTS: A total of 109 AAA patients underwent EVAR using the C3 EXCLUDER. The median follow-up duration was 729 days (interquartile range, 542-1,069 days). Technical success was achieved in 98.2% of cases. Adjunctive, unplanned proximal cuff-extender implantation was required in 8 patients (9.2%). Of the total number, 29 (24.8%) were categorized as being treated outside the IFU. No significant difference was observed in freedom from overall mortality or aneurysm-related mortality between patients treated within and outside the IFU. Freedom from reintervention tended to be lower in patients treated outside the IFU. There was aneurysm sac shrinkage (≥5 mm) in 30.3% and 39.1%; stable aneurysm sac in 69.7% and 56.3%; and aneurysm sac expansion (≥5 mm) in 0% and 4.7% of cases at 1 and 2 years, respectively. No significant difference was observed in aneurysm sac shrinkage between patients treated within and outside the IFU. CONCLUSIONS: The C3 EXCLUDER showed good clinical performance and aneurysm sac shrinkage, regardless of whether the patient was treated within or outside the IFU. The results suggest, however, that in those treated outside the IFU, precise planning, careful operative procedure, and subsequent follow-up are required to obtain short-term and mid- to long-term success in EVAR for AAA using the C3 EXCLUDER.


Assuntos
Aneurisma da Aorta Abdominal/cirurgia , Implante de Prótese Vascular/instrumentação , Prótese Vascular , Procedimentos Endovasculares/instrumentação , Rotulagem de Produtos , Stents , Idoso , Idoso de 80 Anos ou mais , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/mortalidade , Prótese Vascular/normas , Implante de Prótese Vascular/efeitos adversos , Implante de Prótese Vascular/mortalidade , Implante de Prótese Vascular/normas , Bases de Dados Factuais , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/mortalidade , Procedimentos Endovasculares/normas , Feminino , Fidelidade a Diretrizes , Humanos , Masculino , Complicações Pós-Operatórias/etiologia , Guias de Prática Clínica como Assunto , Intervalo Livre de Progressão , Desenho de Prótese , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Stents/normas , Fatores de Tempo , Tóquio
6.
Can J Surg ; 62(1): 66-69, 2019 02 01.
Artigo em Inglês | MEDLINE | ID: mdl-30693748

RESUMO

The Vascular Quality Initiative (VQI) is a national cooperative quality-improvement initiative designed to evaluate processes of care and outcomes in vascular surgery. The purpose of this report is to show the utility of such a database to provide insight into the standard of care provided, to highlight areas of local quality improvement, to benchmark our data against local, regional and national trends, and to ultimately improve safety in Canadian patients undergoing vascular surgery. We present the history of the database, its spread in the Canadian health care system and examples of quality improvements achieved from analyses of data recorded and retrieved from the VQI. Using the VQI, our institution was able to decrease the length of stay after endovascular aneurysm repair, decrease the contrast volume in endovascular aneurysm repair, save on costs, and provide medium-term outcome data on peripheral vascular interventions and smoking cessation strategies. The VQI is a powerful tool to improve patient safety and quality in vascular surgery. Its ability to create local regional improvement groups fosters a quality-focused culture and is important for Canadian patients.


Assuntos
Segurança do Paciente , Melhoria de Qualidade/normas , Procedimentos Cirúrgicos Vasculares/normas , Implante de Prótese Vascular/efeitos adversos , Implante de Prótese Vascular/normas , Canadá , Bases de Dados Factuais , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/normas , Feminino , Humanos , Incidência , Masculino , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/fisiopatologia , Medição de Risco , Resultado do Tratamento , Procedimentos Cirúrgicos Vasculares/efeitos adversos
8.
Gen Thorac Cardiovasc Surg ; 66(12): 685-691, 2018 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-30225772

RESUMO

INTRODUCTION: The current guidelines for surgical intervention of aortic regurgitation were developed by assuming aortic valve replacement. However, when aortic valve repair is considered, earlier intervention may provide more durable repair. Standardization of the procedures may be required to achieve stable outcomes. The possibility of standardization of valve-sparing root replacement (VSRR) and annuloplasty will be discussed. METHODS AND RESULTS: The differences between the two VSRRs have decreased with technical modifications, reimplantation using a graft with sinuses, and remodeling with annuloplasty. The minor differences are the maintenance of root distensibility, less root dissection, shorter procedure time, and higher risk of bleeding in the latter. Stable outcomes may be expected by choosing the appropriate graft size according to the root dimensions in the former. In the latter, postoperative commissure height depends on the skill of the surgeon, which can be resolved using a graft with sinuses. There is still controversy regarding the equal arrangement of the commissure heights and angle, but it has been accepted in clinical use provided that postoperative effective heights of each cusp are set equally. External suture annuloplasty maintains the advantages of remodeling because it requires less root dissection and a shorter procedure time. It can accurately predict postoperative annulus diameter. External ring annuloplasty can stabilize the basal ring exactly, but it is time-consuming and postoperative annulus diameter cannot be predicted accurately. CONCLUSIONS: Standardization of VSRR may be feasible, and VSRR is expected to be more widely adopted, which will improve the guidelines.


Assuntos
Insuficiência da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Implante de Prótese Vascular/normas , Anuloplastia da Valva Cardíaca/normas , Adulto , Dissecação , Feminino , Próteses Valvulares Cardíacas , Humanos , Masculino , Pessoa de Meia-Idade , Reimplante , Resultado do Tratamento , Valva Tricúspide/cirurgia
9.
J Vasc Surg ; 68(5): 1438-1445, 2018 11.
Artigo em Inglês | MEDLINE | ID: mdl-29937289

RESUMO

OBJECTIVE: In 2009, the Society for Vascular Surgery (SVS) developed objective performance goals (OPGs) to define the therapeutic benchmarks in critical limb ischemia (CLI) based on outcomes from randomized trials of lower extremity bypass (LEB). Current performance relative to these benchmarks in both LEB and infrainguinal endovascular intervention (IEI) remains unknown. The objective of this study was to determine whether LEB and IEI performed for CLI in a contemporary national cohort met OPG 30-day safety thresholds. METHODS: SVS OPG criteria were applied to 11,043 revascularizations for CLI performed from 2011 to 2015 in the National Surgical Quality Improvement Program (NSQIP) vascular targeted modules. Primary 30-day safety OPGs including major adverse cardiovascular events (MACEs), major adverse limb events (MALEs), and amputation were calculated for the NSQIP LEB (n = 3833) and IEI (n = 3526) cohorts as well as for subgroups at "high anatomic risk" (infrapopliteal revascularization) and "high clinical risk" (age >80 years and tissue loss). These were compared with SVS OPG benchmarks using χ2 comparisons. RESULTS: Compared with the SVS OPG cohort, both the NSQIP LEB and IEI cohorts had fewer patients at high anatomic risk (LEB, 51%; IEI, 27%; SVS OPG, 60%; both P < .0001). The LEB cohort had fewer patients with high clinical risk than the SVS OPG cohort (LEB, 11%; SVS OPG, 16%; P < .0001). The 30-day MALE was significantly higher in the NSQIP LEB (9.0% [8.7%-9.2%]) and IEI (9.7% [9.4%-10.0%]) cohorts compared with the SVS OPG cohort (6.1% [4.7%-9.0%]; both P ≤ .007), including significantly higher rates of amputation. MACE was significantly lower in the NSQIP LEB (4.2% [4.1%-4.3%]) and IEI (3.1% [3.0%-3.2%]) cohorts compared with the SVS OPG cohort (6.1% [4.7%-8.1%]; both P ≤ .013). Among patients at high anatomic risk, 30-day MALE was significantly higher after LEB (9.5% [9.1%-9.8%]) and IEI (11.1% [10.4-11.8%]) compared with the SVS OPG cohort (6.1% [4.2%-8.6%]; P ≤ .002). Among patients with high clinical risk, IEI was associated with lower MACE compared with the SVS OPG cohort, with similar limb-related outcomes. CONCLUSIONS: In contemporary real-world practice, LEB and IEI for CLI failed to meet SVS OPG limb-related 30-day safety benchmarks for the entire CLI cohort as well as for the patients at high anatomic risk. Additional investigation using SVS OPGs as consistent end points is required to determine why limb-related outcomes after revascularization for CLI remain suboptimal. LEB and IEI surpassed OPG benchmarks for 30-day cardiovascular morbidity and mortality. OPGs for cardiovascular morbidity in patients undergoing revascularization for CLI deserve re-evaluation using contemporary data.


Assuntos
Benchmarking/normas , Implante de Prótese Vascular/normas , Procedimentos Endovasculares/normas , Isquemia/cirurgia , Doença Arterial Periférica/cirurgia , Indicadores de Qualidade em Assistência à Saúde/normas , Sociedades Médicas/normas , Idoso , Idoso de 80 Anos ou mais , Amputação , Implante de Prótese Vascular/efeitos adversos , Implante de Prótese Vascular/mortalidade , Estado Terminal , Bases de Dados Factuais , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/mortalidade , Feminino , Humanos , Isquemia/mortalidade , Salvamento de Membro/normas , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/mortalidade , Complicações Pós-Operatórias/mortalidade , Complicações Pós-Operatórias/cirurgia , Reoperação , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Estados Unidos/epidemiologia
10.
Eur J Vasc Endovasc Surg ; 56(3): 426-433, 2018 09.
Artigo em Inglês | MEDLINE | ID: mdl-29895398

RESUMO

OBJECTIVE: To evaluate radiation exposure in standard endovascular aneurysm repair (EVAR) using intra-operative guidance with pre-operative computed tomographic angiography (CTA) fusion and strict ALARA guidelines in a modern hybrid room. MATERIAL AND METHODS: Between February and November 2016, consecutive patients with AAA undergoing EVAR with a bifurcated device in a hybrid room under fusion imaging guidance were prospectively enrolled in six aortic centres from the United States (n = 1), Europe (n = 4), and Japan (n = 1). Demographic data including body mass index (BMI), indirect dose area product (DAP), cumulative air kerma (CAK), variables influencing dose delivery, and contrast media volume were collected. RESULTS: 85 patients (90.4% males) were included. The median age was 75 (IQR 69-81), with a median BMI of 27.4 (IQR 24.7-30.6). Median DAP and CAK were 14.7 (IQR 10.0-27.7) Gy·cm2 and 107 (IQR 68.0-189.0) mGy, respectively. The median contrast volume was 47 mL (IQR 35-70) (equivalent to 14.1g of iodine [IQR 10.5-21.0]). Median DAP per centre was 28.1 (n = 16, IQR 12.6-47.1), 15.9 (n = 11, IQR 11.9-22.5), 14.2 (n = 12, IQR 10.9-25.7), 20.2 (n = 18, IQR 7.0-39.5), 10.3 (n = 27, IQR 8.2-14.7) and 26.5 (n = 1) Gy·cm2. In multivariable analysis, collimation was the only factor that was significantly associated with DAP reduction, (coefficient = -0.014 per percentage of collimation, 95% CI -0.019 to -0.008, p < .001). CONCLUSIONS: With adherence to the ALARA principle and routine application of fusion imaging guidance for EVAR, low radiation exposure compared with the published literature can be achieved in a real world setting.


Assuntos
Aneurisma da Aorta Abdominal/cirurgia , Implante de Prótese Vascular , Procedimentos Endovasculares , Doses de Radiação , Exposição à Radiação/prevenção & controle , Proteção Radiológica/métodos , Radiografia Intervencionista , Idoso , Idoso de 80 Anos ou mais , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aortografia/métodos , Implante de Prótese Vascular/efeitos adversos , Implante de Prótese Vascular/normas , Angiografia por Tomografia Computadorizada , Meios de Contraste/administração & dosagem , Meios de Contraste/efeitos adversos , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/normas , Europa (Continente) , Feminino , Fidelidade a Diretrizes , Humanos , Japão , Masculino , Cidade de Nova Iorque , Duração da Cirurgia , Segurança do Paciente , Guias de Prática Clínica como Assunto , Valor Preditivo dos Testes , Estudos Prospectivos , Exposição à Radiação/efeitos adversos , Exposição à Radiação/normas , Monitoramento de Radiação , Proteção Radiológica/normas , Radiografia Intervencionista/efeitos adversos , Radiografia Intervencionista/normas , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
11.
Circulation ; 137(24): 2635-2650, 2018 06 12.
Artigo em Inglês | MEDLINE | ID: mdl-29891620

RESUMO

The Academic Research Consortium (ARC)-2 initiative revisited the clinical and angiographic end point definitions in coronary device trials, proposed in 2007, to make them more suitable for use in clinical trials that include increasingly complex lesion and patient populations and incorporate novel devices such as bioresorbable vascular scaffolds. In addition, recommendations for the incorporation of patient-related outcomes in clinical trials are proposed. Academic Research Consortium-2 is a collaborative effort between academic research organizations in the United States and Europe, device manufacturers, and European, US, and Asian regulatory bodies. Several in-person meetings were held to discuss the changes that have occurred in the device landscape and in clinical trials and regulatory pathways in the last decade. The consensus-based end point definitions in this document are endorsed by the stakeholders of this document and strongly advocated for clinical trial purposes. This Academic Research Consortium-2 document provides further standardization of end point definitions for coronary device trials, incorporating advances in technology and knowledge. Their use will aid interpretation of trial outcomes and comparison among studies, thus facilitating the evaluation of the safety and effectiveness of these devices.


Assuntos
Bioprótese/normas , Implante de Prótese Vascular/normas , Prótese Vascular/normas , Vasos Coronários/cirurgia , Desenho de Prótese/normas , Stents/normas , Estenose da Valva Aórtica , Ensaios Clínicos como Assunto , Consenso , Humanos
12.
J Vasc Access ; 19(5): 422-429, 2018 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-29544403

RESUMO

The Spanish Multidisciplinary Group on Vascular Access (GEMAV), which includes experts from the five scientific societies involved (nephrology (S.E.N.), vascular surgery (SEACV), interventional radiology (SERAM-SERVEI), infectious diseases (SEIMC), and nephrology nursing (SEDEN)), along with the methodological support of the Iberoamerican Cochrane Centre, has developed the Spanish Clinical Guidelines on Vascular Access for Hemodialysis. This article summarizes the main issues from the guideline's chapter entitled "Monitoring and surveillance of arteriovenous access." We will analyze the current evidence on conflicting topics such as the value of the flow-based screening methods for the arteriovenous access surveillance or the role of Doppler ultrasound as the imaging exploration to confirm suspected stenosis. In addition, the concept of significant stenosis and the criteria to perform the elective intervention for stenosis were reviewed. The adoption of these guidelines will hopefully translate into a reduced risk of thrombosis and increased patency rates for both arteriovenous fistulas and grafts.


Assuntos
Derivação Arteriovenosa Cirúrgica/normas , Implante de Prótese Vascular/normas , Oclusão de Enxerto Vascular/diagnóstico por imagem , Falência Renal Crônica/terapia , Diálise Renal/normas , Trombose/diagnóstico por imagem , Derivação Arteriovenosa Cirúrgica/efeitos adversos , Implante de Prótese Vascular/efeitos adversos , Tomada de Decisão Clínica , Oclusão de Enxerto Vascular/etiologia , Oclusão de Enxerto Vascular/fisiopatologia , Humanos , Falência Renal Crônica/diagnóstico , Falência Renal Crônica/fisiopatologia , Valor Preditivo dos Testes , Fatores de Risco , Espanha , Trombose/etiologia , Trombose/fisiopatologia , Resultado do Tratamento , Grau de Desobstrução Vascular
13.
Ann Vasc Surg ; 49: 144-151, 2018 May.
Artigo em Inglês | MEDLINE | ID: mdl-29428533

RESUMO

BACKGROUND: The Nellix was introduced to Asia in 2014. Data in Asians have been sparse. Two balloon-expandable stents, each surrounded by a polymer-filled endobag, are deployed in parallel to obliterate and seal the aneurysm. This paradigm shift to treating abdominal aortic aneurysms confers advantages for certain adverse aneurysm morphology that is outside the instruction-for-use (IFU) for standard endovascular aneurysm repair (EVAR) devices. We examine outcomes of 15 Asian patients with concomitant infrarenal aortic and iliac artery aneurysms treated with the Nellix at our institution. METHOD: Between July 2014 and August 2016, 15 male patients underwent elective EVAS at a single tertiary center by the same team of vascular surgeons and interventional radiologists. Patient demographics, clinical presentations, aneurysm morphology, perioperative complications, and follow-up imaging according to the standardized protocol were studied. Preoperative CT images were analyzed using validated automatic 3-dimensional sizing software EndoSize. RESULT: The novel stent-graft deployment proves consistent and achieved a 100% technical success. Eleven patients (70%) complied within specified Nellix IFU, as compared to 20% if standard endovascular aneurysm repair (EVAR) IFU was applied. The difference is due to the presence of concurrent common iliac aneurysms (n = 5), short neck length (n = 3), and angulated necks (n = 3). Adjunct procedures included 3 open access endarterectomy with embolectomy, 1 coil embolization of internal iliac artery, 1 bilateral renal artery chimneys, and 1 proximal stent deployment. There was no conversion to open surgery. Average operative time was 133 min. Median length of stay was 4 days. Thirty-day mortality was 0%. Perioperative morbidity included exacerbation of pre-existing renal impairment (n = 6), peripheral vascular disease (n = 3), and postimplantation syndrome (n = 5). One endoleak (7%) and 2 instances of stent migration (14%) were detected. There was no complication of aneurysm or endobag rupture, limb thromboses, or fracture. CONCLUSIONS: Early data in our center are encouraging and highlight high procedural success with minimal complications despite challenging patient anatomy.


Assuntos
Aneurisma da Aorta Abdominal/cirurgia , Implante de Prótese Vascular/instrumentação , Prótese Vascular , Procedimentos Endovasculares/instrumentação , Fidelidade a Diretrizes , Aneurisma Ilíaco/cirurgia , Padrões de Prática Médica , Stents , Idoso , Idoso de 80 Anos ou mais , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aortografia/métodos , Prótese Vascular/normas , Implante de Prótese Vascular/efeitos adversos , Implante de Prótese Vascular/normas , Tomada de Decisão Clínica , Angiografia por Tomografia Computadorizada , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/normas , Fidelidade a Diretrizes/normas , Humanos , Aneurisma Ilíaco/diagnóstico por imagem , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Duração da Cirurgia , Complicações Pós-Operatórias/etiologia , Guias de Prática Clínica como Assunto , Padrões de Prática Médica/normas , Desenho de Prótese , Interpretação de Imagem Radiográfica Assistida por Computador , Singapura , Stents/normas , Centros de Atenção Terciária , Fatores de Tempo , Resultado do Tratamento
14.
J Vasc Surg ; 67(1): 332-342, 2018 01.
Artigo em Inglês | MEDLINE | ID: mdl-28844469

RESUMO

OBJECTIVE: Endovascular repair of the ascending aorta is currently limited to patients at high surgical risk with aortic diseases originating above the sinotubular junction. A number of different endovascular technologies and approaches have been used, although no consensus exists regarding a standardized technique. To better understand real-world endovascular approaches to the ascending aorta, we performed a comprehensive review of the types of endovascular aortic stents and associated vascular access used in repair of the ascending aorta. METHODS: A search of the MEDLINE database was conducted from January 1, 1995, through January 31, 2017, with the search term "ascending aortic stent." Studies involving endovascular stenting in which the primary therapy was confined exclusively to the ascending aorta were included. Studies involving hybrid arch procedures and surgical replacement of the ascending aorta associated with aortic stenting were excluded. The type of aortic stent, underlying aortic disease, and surgical approach were recorded along with outcomes, need for reinterventions, and follow-up. RESULTS: A total of 46 publications that focused on primary endovascular repair of the ascending aorta were identified. Thirteen different aortic stent grafts of various designs were used in 118 total patients. The most commonly used device types were thoracic stents (n = 84 [71.2%]) along with abdominal cuffs (n = 13 [11%]) and custom-made grafts (n = 12 [10.2%]). The most commonly treated aortic disease was type A aortic dissection (n = 59 [50%]), followed by aortic pseudoaneurysm (n = 35 [29.7%]), aortic aneurysm (n = 6 [5.1%]), penetrating atherosclerotic ulcer (n = 5 [4.2%]), and acute aortic rupture (n = 3 [2.5%]). Femoral arterial access was used in 62.7% of patients (n = 74); transapical (n = 17 [14.4%]), carotid (n = 15 [12.7%]), and axillary (n = 8 [6.8%]) approaches were also used. The overall type I endoleak rate was 18.6% (n = 22), with 11 patients (9.3%) requiring reintervention. Other complications included all-cause mortality (n = 18 [15.2%]), conversions to open surgery (n = 4 [3.4%]), and cerebrovascular complications (n = 4 [3.4%]). Aorta-related mortality was 5% (n = 6), and average follow-up was 17.2 months. CONCLUSIONS: Despite the absence of a dedicated aortic stent graft for the ascending aorta, patients with a range of ascending aortic diseases are being successfully treated by endovascular technologies. For optimal outcomes, patient selection is critical to align aortic anatomy with the limited device sizing options, and it should be reserved for patients at high surgical risk.


Assuntos
Aorta/cirurgia , Doenças da Aorta/cirurgia , Implante de Prótese Vascular/métodos , Procedimentos Endovasculares/métodos , Complicações Pós-Operatórias/epidemiologia , Doenças da Aorta/mortalidade , Implante de Prótese Vascular/efeitos adversos , Implante de Prótese Vascular/instrumentação , Implante de Prótese Vascular/normas , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/instrumentação , Procedimentos Endovasculares/normas , Humanos , Seleção de Pacientes , Complicações Pós-Operatórias/etiologia , Reoperação/estatística & dados numéricos , Stents/efeitos adversos , Resultado do Tratamento
15.
J Vasc Surg ; 67(4): 1217-1226, 2018 04.
Artigo em Inglês | MEDLINE | ID: mdl-29103931

RESUMO

OBJECTIVE: The urgency with which salvage of thrombosed vascular accesses for dialysis should be attempted remains unknown. We examined the effect of a timely thrombectomy approach on vascular access outcomes for dialysis. METHODS: A before-and-after study was conducted with patients on hemodialysis who had undergone endovascular thrombectomy. A timely thrombectomy initiative (ie, salvage within 24 hours of thrombosis diagnosis) was started in July 2015 at our institution. Data about thrombectomy procedures, performed within 1 year before and after the initiative was introduced, were abstracted from an electronic database. Immediate outcomes and patency outcomes were compared between the preinitiative (control) and postinitiative (intervention) groups. RESULTS: During the study period, 329 patients were enrolled, including 165 cases before and 164 cases after the initiative. The intervention group had more thrombectomy procedures performed within 24 hours (93% vs 55%; P < .01) and within 48 hours (97% vs 79%; P < .01) than the control group. No between-group differences in procedural success or clinical success rates were found. At 3 months, the intervention group had a higher postintervention primary patency rate than the control group, although this did not reach statistical significance (58% vs 48%; P = .06). After stratification into native or graft accesses, the patency benefit was observed in the native access group (68% vs 50%; P = .03) but not in the graft access group (50% vs 46%; P = .65). After adjusting for potential confounders, timely thrombectomy remained an independent predictor of postintervention primary patency (hazard ratio, 0.449; 95% confidence interval, 0.224-0.900; P = .02) for native dialysis accesses. CONCLUSIONS: Our results suggest that a timely thrombectomy approach, in which salvage is attempted within 24 hours of thrombosis diagnosis, improves postintervention primary patency of native but not graft accesses for dialysis.


Assuntos
Derivação Arteriovenosa Cirúrgica/efeitos adversos , Implante de Prótese Vascular/efeitos adversos , Oclusão de Enxerto Vascular/terapia , Diálise Renal , Trombectomia , Trombose/terapia , Tempo para o Tratamento , Grau de Desobstrução Vascular , Idoso , Idoso de 80 Anos ou mais , Derivação Arteriovenosa Cirúrgica/métodos , Derivação Arteriovenosa Cirúrgica/normas , Implante de Prótese Vascular/métodos , Implante de Prótese Vascular/normas , Distribuição de Qui-Quadrado , Bases de Dados Factuais , Feminino , Oclusão de Enxerto Vascular/diagnóstico por imagem , Oclusão de Enxerto Vascular/etiologia , Oclusão de Enxerto Vascular/fisiopatologia , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Avaliação de Programas e Projetos de Saúde , Modelos de Riscos Proporcionais , Melhoria de Qualidade , Indicadores de Qualidade em Assistência à Saúde , Estudos Retrospectivos , Fatores de Risco , Terapia de Salvação , Trombectomia/efeitos adversos , Trombectomia/normas , Trombose/diagnóstico por imagem , Trombose/etiologia , Trombose/fisiopatologia , Fatores de Tempo , Tempo para o Tratamento/normas , Resultado do Tratamento
16.
J Vasc Surg ; 67(1): 126-133, 2018 01.
Artigo em Inglês | MEDLINE | ID: mdl-28760581

RESUMO

BACKGROUND: A variety of devices exist for endovascular aneurysm repair (EVAR). Device-specific instructions for use (IFU) detail anatomic constraints to application and deployment of devices and are developed from rigorous bench testing. Nonadherence to IFU occurs frequently to avoid open surgery. The purpose of this study was to determine if IFU violations are associated with increased risk of graft-related adverse events (GRAEs) during follow-up. METHODS: This multicenter retrospective observational study included patients undergoing elective endovascular repair for abdominal aneurysmal disease with three different devices. Demographics, anatomic data, and follow-up data were collected on patients from 2005 to 2014. IFU violations were device specific and included neck diameter, length, and angulation and iliac artery diameter and length. GRAEs included a composite outcome of reintervention, migration, endoleak (type II excluded), rupture, limb occlusion, sac growth, and aneurysm-related mortality during the follow-up period. Kaplan-Meier survival and Cox proportional hazards modeling were performed. Any IFU violations as well as neck-specific IFU violations were analyzed. RESULTS: In 461 patients undergoing EVAR, 43.8% had at least one IFU violation. Patients with IFU violations were more likely to have peripheral vascular disease (12.4% vs 7.3%) and were less likely to be male (78.7% vs 90.3%). The most frequent IFU violations included diameter deviations of the neck (15.2%) and of the iliac artery (21.4%). Overall, the GRAE rate was 12.8%. Median follow-up time was 1.9 and 2.1 years for patients with and without an IFU violation, respectively. Kaplan-Meier survival revealed a significant association between the presence of an IFU violation and GRAEs (log-rank, P = .031). When adjusted for clinical variable through Cox hazard modeling, the association remained significant (hazard ratio 1.8; 95% confidence interval, 1.05-3.1). When neck-specific violations were considered independently, Kaplan-Meier survival (log-rank, P = .003) and Cox modeling (hazard ratio, 2.2; 95% confidence interval, 1.2-4.0) revealed a significant association between neck-specific IFU violation and GRAEs. CONCLUSIONS: A total of 43.8% of patients undergoing EVAR had a device-specific IFU violation, indicating that implanters are pushing the boundaries of device capabilities. Our study identified that any IFU violation was significantly associated with GRAEs over time. Caution should be applied to patients being considered for EVAR when IFU deviations exist.


Assuntos
Aneurisma da Aorta Abdominal/cirurgia , Implante de Prótese Vascular/efeitos adversos , Procedimentos Cirúrgicos Eletivos/efeitos adversos , Procedimentos Endovasculares/efeitos adversos , Fidelidade a Diretrizes/estatística & dados numéricos , Complicações Pós-Operatórias/epidemiologia , Idoso , Idoso de 80 Anos ou mais , Aorta Abdominal/diagnóstico por imagem , Aorta Abdominal/cirurgia , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/mortalidade , Aortografia/métodos , Prótese Vascular/efeitos adversos , Prótese Vascular/normas , Implante de Prótese Vascular/instrumentação , Implante de Prótese Vascular/métodos , Implante de Prótese Vascular/normas , Angiografia por Tomografia Computadorizada/métodos , Procedimentos Cirúrgicos Eletivos/instrumentação , Procedimentos Cirúrgicos Eletivos/métodos , Procedimentos Cirúrgicos Eletivos/normas , Procedimentos Endovasculares/instrumentação , Procedimentos Endovasculares/métodos , Procedimentos Endovasculares/normas , Feminino , Seguimentos , Humanos , Estimativa de Kaplan-Meier , Masculino , Seleção de Pacientes , Complicações Pós-Operatórias/diagnóstico por imagem , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/prevenção & controle , Guias de Prática Clínica como Assunto , Reoperação/estatística & dados numéricos , Estudos Retrospectivos , Medição de Risco , Fatores Sexuais , Stents/efeitos adversos , Stents/normas , Fatores de Tempo , Resultado do Tratamento
17.
Surgery ; 162(5): 979-988, 2017 11.
Artigo em Inglês | MEDLINE | ID: mdl-28720226

RESUMO

Repair of abdominal aortic aneurysms with endovascular techniques has emerged as the first line of therapy, due to procedural ease and excellent patient outcomes. Open aneurysm repair is increasingly used as a secondary option for lesions with anatomic complexity that involve arterial branches. Understanding the impact of endovascular abdominal aortic aneurysms repair on the shift in vascular operation practice for abdominal aortic aneurysms repair, requires a comprehensive and risk-adjusted review of operative outcomes between the 2 repair types. The American College of Surgeons National Surgical Quality Improvement Project is a comprehensive, outcomes-based program, which provides valuable data on operative complications with endovascular and open repair. In this review, we use the National Surgical Quality Improvement Project database to critically review complications, mortality, and morbidity associated with endovascular and open abdominal aneurysmal repair.


Assuntos
Aneurisma da Aorta Abdominal/cirurgia , Implante de Prótese Vascular/métodos , Bases de Dados Factuais , Procedimentos Endovasculares , Melhoria de Qualidade , Implante de Prótese Vascular/normas , Procedimentos Endovasculares/normas , Humanos
18.
Acta Cardiol ; 72(2): 142-148, 2017 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-28597797

RESUMO

Introduction In traditional locations, the standard Blalock-Taussig shunt presents numerous technical difficulties for percutaneous intervention. We changed our strategy to a central type shunt (Laks-type) with end-to-side pulmonary and side-to-side aortic anastomosis. The aim of this study was to determine whether this modified strategy would allow easier percutaneous manipulation in patients with small pulmonary arteries. Methods All children with a stretchable central vascular graft who required any form of percutaneous intervention were prospectively enrolled in the study. Results Eleven infants were evaluated a median time of 3 months (range 0.9-4.4) following initial shunt placement; the median weight at intervention was 5.7 kg (range: 4.0 - 10.0). All shunts (100%) were easily and swiftly entered without the need for special catheters or co-axial systems. In four patients other interventions in distal pulmonary arteries were first performed: cutting balloon treatment in three and balloon angioplasty of peripheral pulmonary artery stenosis in one. The shunts were then augmented with a stent with a diameter increasing from 3.5 ± 0.4 mm to 4.7 ± 0.8 mm and saturation increasing from 76% (range: 69-88) to 84% (range: 77-88) (P < 0.05). Several months later, two children required further interventions that could easily be performed via the stented shunts. No complications were observed. Conclusions The Laks-type shunt provides easy access for percutaneous procedures of the distal pulmonary arteries including cutting balloons; this shunt can predictably be expanded to augment pulmonary flow. This study highlights how co-operation between the interventionalist and the surgeon can improve strategies to manage these difficult patients.


Assuntos
Aorta Torácica/cirurgia , Implante de Prótese Vascular/métodos , Cateterismo Cardíaco/métodos , Guias de Prática Clínica como Assunto , Artéria Pulmonar/cirurgia , Stents , Angiografia , Aorta Torácica/diagnóstico por imagem , Implante de Prótese Vascular/normas , Cateterismo Cardíaco/normas , Feminino , Seguimentos , Cardiopatias Congênitas/cirurgia , Humanos , Lactente , Masculino , Estudos Prospectivos , Desenho de Prótese , Artéria Pulmonar/diagnóstico por imagem , Resultado do Tratamento
19.
Eur J Vasc Endovasc Surg ; 54(1): 34-41, 2017 07.
Artigo em Inglês | MEDLINE | ID: mdl-28549712

RESUMO

OBJECTIVE/BACKGROUND: To develop a procedure specific global rating scale for assessment of operator competence in endovascular aortic repair (EVAR). METHODS: A Delphi approach was used to achieve expert consensus. A panel of 32 international experts (median 300 EVAR procedures, range 200-3000) from vascular surgery (n = 21) and radiology (n = 11) was established. The first Delphi round was based on a review of endovascular skills assessment papers, stent graft instructions for use, and structured interviews. It led to a primary pool of 83 items that were formulated as global rating scale items with tentative anchors. Iterative Delphi rounds were executed. The panellists rated the importance of each item on a 5 point Likert scale. Consensus was defined as 80% of the panel rating an item 4 or 5 in the primary round and 90% in subsequent rounds. Consensus on the final assessment tool was defined as Cronbach's alpha > .8 after a minimum of three rounds. RESULTS: Thirty-two of 35 invited experts participated. Three rounds of surveys were completed with a completion rate of 100% in the first two rounds and 91% in round three. The 83 primary assessment items were supplemented with five items suggested by the panel and reduced to seven pivotal assessment items that reached consensus, Cronbach's alpha = 0.82. The seven item rating scale covers key elements of competence in EVAR stent placement and deployment. Each item has well defined grades with explicit anchors at unacceptable, acceptable, and superior performance on a 5 point Likert scale. CONCLUSION: The Delphi methodology allowed for international consensus on a new procedure specific global rating scale for assessment of competence in EVAR. The resulting scale, EndoVascular Aortic Repair Assessment of Technical Expertise (EVARATE), represents key elements in the procedure. EVARATE constitutes an assessment tool for providing structured feedback to endovascular operators in training.


Assuntos
Aneurisma da Aorta Abdominal/cirurgia , Implante de Prótese Vascular/normas , Competência Clínica/normas , Técnica Delfos , Procedimentos Endovasculares/normas , Indicadores de Qualidade em Assistência à Saúde/normas , Adulto , Idoso , Prótese Vascular , Implante de Prótese Vascular/efeitos adversos , Implante de Prótese Vascular/instrumentação , Consenso , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/instrumentação , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Stents , Análise e Desempenho de Tarefas , Resultado do Tratamento
20.
Tech Vasc Interv Radiol ; 20(1): 2-8, 2017 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-28279405

RESUMO

Dialysis vascular access management in the United States changed significantly after National Kidney Foundation-Kidney Disease Outcome Quality Initiative (NKF-KDOQI) clinical practice guidelines were first published in 1997. The Centers for Medicare and Medicaid Service adopted these guidelines and in collaboration with the End-Stage Renal Disease Networks established the Fistula First Breakthrough Initiative (FFBI) in 2003 to improve the rate of arteriovenous fistula use over arteriovenous graft and central venous catheter in the dialysis population. The implementation of guidelines and FFBI has led to a significant increase in the arteriovenous fistula use in the prevalent dialysis population. The guidelines are criticized for being opinion based and often impractical. Over the past 2 decades, the patient population undergoing dialysis has become older with complex comorbidities and challenges for creating an ideal vascular access. Advancing knowledge about access pathophysiology, improved treatment options, and improved process of care with team approach model point toward diminishing relevance of few of the existing guidelines. Moreover, several guidelines remain controversial and may be leading to clinical decisions that may be unfavorable to the patients. The review discusses the historical aspect of vascular access care in the United States and evolution of current practice standards and controversies surrounding few of these guidelines in the current time.


Assuntos
Derivação Arteriovenosa Cirúrgica/normas , Implante de Prótese Vascular/normas , Cateterismo Venoso Central/normas , Falência Renal Crônica/terapia , Guias de Prática Clínica como Assunto/normas , Diálise Renal/normas , Idoso , Derivação Arteriovenosa Cirúrgica/efeitos adversos , Derivação Arteriovenosa Cirúrgica/história , Implante de Prótese Vascular/efeitos adversos , Implante de Prótese Vascular/história , Cateterismo Venoso Central/efeitos adversos , Cateterismo Venoso Central/história , Feminino , Fidelidade a Diretrizes/normas , História do Século XX , História do Século XXI , Humanos , Falência Renal Crônica/diagnóstico , Falência Renal Crônica/epidemiologia , Falência Renal Crônica/história , Masculino , Pessoa de Meia-Idade , Seleção de Pacientes , Padrões de Prática Médica/normas , Diálise Renal/história , Fatores de Risco , Resultado do Tratamento , Estados Unidos/epidemiologia
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