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1.
Ann Surg ; 2024 Jun 06.
Artigo em Inglês | MEDLINE | ID: mdl-38841837

RESUMO

BACKGROUND: There are limited data supporting or opposing the use of infrapopliteal peripheral vascular interventions (PVI) for the treatment of claudication. OBJECTIVES: We aimed to evaluate the association of infrapopliteal PVI with long-term outcomes compared with isolated femoropopliteal PVI for the treatment of claudication. METHODS: We conducted a retrospective analysis of all patients in the Medicare-matched Vascular Quality Initiative database who underwent an index infrainguinal PVI for claudication from January 2004-December 2019 using Cox proportional hazards models. RESULTS: Of 14,261 patients (39.9% female; 85.6% age ≥65 years, 87.7% non-Hispanic white) who underwent an index infrainguinal PVI for claudication, 16.6% (N=2,369) received an infrapopliteal PVI. The median follow-up after index PVI was 3.7 years (IQR 2.1-6.1). Compared to patients who underwent isolated femoropopliteal PVI, patients receiving any infrapopliteal PVI had a higher 3-year cumulative incidence of conversion to CLTI (33.3% vs. 23.8%; P<0.001); repeat PVI (41.0% vs. 38.2%; P<0.01); and amputation (8.1% vs. 2.8%; P<0.001). After risk-adjustment, patients undergoing infrapopliteal PVI had a higher risk of conversion to CLTI (aHR 1.39, 95% CI, 1.25-1.53); repeat PVI (aHR 1.10, 95% CI, 1.01-1.19); and amputation (aHR 2.18, 95% CI, 1.77-2.67). Findings were consistent after adjusting for competing risk of death; in a 1:1 propensity-matched analysis; and in subgroup analyses stratified by TASC disease, diabetes, and end-stage kidney disease. CONCLUSIONS: Infrapopliteal PVI is associated with worse long-term outcomes than femoropopliteal PVI for claudication. These risks should be discussed with patients.

2.
J Vasc Surg ; 2024 Jun 20.
Artigo em Inglês | MEDLINE | ID: mdl-38908807

RESUMO

OBJECTIVE: Controversy exists regarding the value and limitations of different sites of service for peripheral artery disease treatment. We aimed to examine practice patterns associated with peripheral vascular interventions (PVIs) performed in the office-based laboratory (OBL) vs outpatient hospital site of service using a nationally representative database. METHODS: Using 100% Medicare fee-for-service claims data, we identified all patients undergoing PVI for claudication or chronic limb-threatening ischemia (CLTI) between January 2017 and December 2022. We evaluated the associations of patient and procedure characteristics with site of service using multivariable hierarchical logistic regression. We used multinomial regression models to estimate the relative risk ratios (RRRs) of site of service and intervention type (angioplasty, stent, or atherectomy) and intervention level (iliac, femoropopliteal, or tibial) after adjusting for baseline patient characteristics and clustering by physician. RESULTS: Of 848,526 PVI, 485,942 (57.3%) were performed in an OBL. OBL use increased significantly over time from 48.3% in 2017 to 65.5% in 2022 (P < .001). Patients treated in OBLs were more likely to be Black (adjusted odds ratio [aOR], 1.14; 95% confidence interval [CI], 1.11-1.18) or other non-White race (aOR, 1.13; 95% CI, 1.08-1.18), have fewer comorbidities, and undergo treatment for claudication vs CLTI (aOR, 1.30; 95% CI, 1.26-1.33) compared with patients treated in outpatient hospital settings. Physicians with majority practice (>50% procedures) in an OBL were more likely to practice in urban settings (aOR, 21.58; 95% CI, 9.31-50.02), specialize in radiology (aOR, 18.15; 95% CI, 8.92- 36.92), and have high-volume PVI practices (aOR, 2.15; 95% CI, 2.10-2.29). The median time from diagnosis to treatment was shorter in OBLs, particularly for patients with CLTI (29 vs 39 days; P < .001). The OBL setting was the strongest predictor of patients receiving an atherectomy alone (adjusted RRR [aRRR] 6.67; 95% CI, 6.59-6.76) or atherectomy + stent (aRRR, 10.84; 95% CI, 10.64-11.05), and these findings were consistent in subgroup analyses stratified by PVI indication. An OBL setting was also associated with higher risk of tibial interventions for both claudication (aRRR, 3.18; 95% CI, 3.11-3.25) and CLTI (aRRR, 1.89; 95% CI, 1.86-1.92). The average reimbursement (including procedure and facility fees) was slightly higher for OBLs compared with the hospital ($8742/case vs $8459/case; P < .001). However, in a simulated cohort resetting the OBL's intervention type distribution to that of the hospital, OBLs were associated with a hypothetical cost savings of $221,219,803 overall and $2602 per case. CONCLUSIONS: The OBL site of service was associated with greater access to care for non-White patients and a shorter time from diagnosis to treatment, but more frequently performed high-cost interventions compared with the outpatient hospital setting. The benefit to patients from improved access to peripheral artery disease care in OBL settings must be balanced with the potential limitations of receiving differential care.

3.
Ann Vasc Surg ; 101: 179-185, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38142961

RESUMO

Racial, ethnic, and socioeconomic disparities in the major risk factors for vascular disease and access to vascular specialist care are well-documented.1-3 The higher incidence of diabetes, peripheral artery disease (PAD), and related nontraumatic lower extremity amputation among racial and ethnic minority groups, those of low socioeconomic status, and those with poor access to care based on geography (together, referred to below as disadvantaged groups) are particularly pervasive.1,4-9 Practitioners of vascular surgery and endovascular therapy are uniquely positioned to address health inequities in lower extremity screening, medical management, intervention, and limb preservation among the population of adults at the highest risk for limb loss.


Assuntos
Etnicidade , Doença Arterial Periférica , Adulto , Humanos , Empatia , Resultado do Tratamento , Grupos Minoritários , Fatores de Risco , Extremidade Inferior/irrigação sanguínea , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/cirurgia , Medição de Risco , Amputação Cirúrgica , Salvamento de Membro
4.
Ann Vasc Surg ; 95: 244-250, 2023 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-37037416

RESUMO

BACKGROUND: There has been an increasing focus on gender disparities in the medical field and in the field of vascular surgery specifically. We aimed to characterize gender representation in vascular surgery innovation over the past 10 years, using metrics of patents and National Institutes of Health (NIH) support. METHODS: We performed a retrospective review of all vascular-related patent filings (Google Scholar) and NIH-funded grants (NIH RePORTER) over a 10-year period (January 1st, 2012, to December 31st, 2021). Gender-API (Application Programming Interface) was used to identify the gender of the inventors, with manual confirmation of a 10% random sample. Gender representation for patent inventors and grant principal investigators (PIs) were compared using Chi-squared and Student's t-tests as appropriate. Yearly temporal changes in representation were analyzed using Wilcoxon signed-rank tests and linear regression analyses. RESULTS: We identified 2,992 unique vascular device patents with 6,093 associated inventors over 10 years. Women were underrepresented in patent authorship overall (11.5%), and were least likely to be listed as first inventor (8.9%) and most commonly fourth and fifth inventors (15.5% and 14.1%, respectively) compared to men. There was no significant change in representation of women inventors over time (-0.2% females per year, 95% confidence interval (CI) -0.54 to 0.10). We identified 1736 total unique NIH grants, with 23.8% of funded projects having women PIs. There was an increase in the proportion of women PIs over time (+1.31% per year, 95% CI 0.784 to 1.855; P < 0.001). Projects with women PIs received mean total awards that were significantly lower than projects with men PIs ($350,485 ± $220,072 vs. $451,493 ± $411,040; P < 0.001), but the overall ratio of funding:women investigators improved over time (+$11,531 per year, 95% CI $6,167 to $16,895; P = 0.0011). CONCLUSIONS: While we have made strides in increasing the number of women in the surgical research space, there is still room for improvement in funding parity. In addition, we found substantial and persistent room for improvement in representation of women in surgical innovation. As we enter a new frontier of surgery hallmarked by equalizing gender representation, these data should serve as a call-to-action for initiative aimed at rebuilding the foundation of surgical innovations upon equal gender representation.


Assuntos
Pesquisa Biomédica , National Institutes of Health (U.S.) , Masculino , Estados Unidos , Humanos , Feminino , Resultado do Tratamento , Organização do Financiamento , Estudos Retrospectivos , Procedimentos Cirúrgicos Vasculares
5.
J Pediatr Surg ; 2024 Apr 09.
Artigo em Inglês | MEDLINE | ID: mdl-38705831

RESUMO

BACKGROUND: National estimates suggest pediatric trauma recidivism is uncommon but are limited by short follow up and narrow ascertainment. We aimed to quantify the long-term frequency of trauma recidivism in a statewide pediatric population and identify risk factors for re-injury. METHODS: The Maryland Health Services Cost Review Commission Dataset was queried for 0-19-year-old patients with emergency department or inpatient encounters for traumatic injuries between 2013 and 2019. We measured trauma recidivism by identifying patients with any subsequent presentation for a new traumatic injury. Univariate and multivariable regressions were used to estimate associations of patient and injury characteristics with any recidivism and inpatient recidivism. RESULTS: Of 574,472 patients with at least one injury encounter, 29.6% experienced trauma recidivism. Age ≤2 years, public insurance, and self-inflicted injuries were associated with recidivism regardless of index treatment setting. Of those with index emergency department presentations 0.06% represented with an injury requiring inpatient admission; unique risk factors for ED-to-inpatient recidivism were age >10 years (aOR 1.61), cyclist (aOR 1.31) or burn (aOR 1.39) mechanisms, child abuse (aOR 1.27), and assault (aOR 1.43). Among patients with at least one inpatient encounter, 6.3% experienced another inpatient trauma admission, 3.4% of which were fatal. Unique risk factors for inpatient-to-inpatient recidivism were firearm (aOR 2.48) and motor vehicle/transportation (aOR 1.62) mechanisms of injury (all p < 0.05). CONCLUSIONS: Pediatric trauma recidivism is more common and morbid than previously estimated, and risk factors for repeat injury differ by treatment setting. Demographic and injury characteristics may help develop and target setting-specific interventions. LEVEL OF EVIDENCE: III (Retrospective Comparative Study).

6.
J Am Heart Assoc ; : e033463, 2024 Jul 03.
Artigo em Inglês | MEDLINE | ID: mdl-38958132

RESUMO

BACKGROUND: Previous cross-sectional studies have identified wide practice pattern variations in the use of peripheral vascular interventions (PVIs) for the treatment of claudication. However, there are limited data on longitudinal practice patterns. We aimed to describe the temporal trends and charges associated with PVI use for claudication over the past 12 years in the United States. METHODS AND RESULTS: We conducted a retrospective analysis using 100% Medicare fee-for-service claims data to identify all patients who underwent a PVI for claudication between January 2011 and December 2022. We evaluated the trends in utilization and Medicare-allowed charges of PVI according to anatomic level, procedure type, and intervention settings using generalized linear models. Multinomial logistic regressions were used to evaluate factors associated with different levels and types of PVI. We identified 599 197 PVIs performed for claudication. The proportional use of tibial PVI increased 1.0% per year, and atherectomy increased by 1.6% per year over the study period. The proportion of PVIs performed in ambulatory surgical centers/office-based laboratories grew at 4% per year from 12.4% in 2011 to 55.7% in 2022. Total Medicare-allowed charges increased by $11 980 035 USD/year. Multinomial logistic regression identified significant associations between race and ethnicity and treatment setting with use of both atherectomy and tibial PVI. CONCLUSIONS: The use of tibial PVI and atherectomy for the treatment of claudication has increased dramatically in in ambulatory surgical center/office-based laboratory settings, non-White patients, and resulting in a significant increase in health care charges. There is a critical need to improve the delivery of value-based care for the treatment of claudication.

7.
Semin Vasc Surg ; 36(1): 114-121, 2023 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-36958892

RESUMO

Major nontraumatic lower extremity amputation (LEA) is a morbid complication of longstanding or poorly controlled diabetes and/or end-stage peripheral artery disease. Incidence of major LEAs consistently declined during the 1990s and 2000s, but rates have plateaued or increased in many regions during the past decade. Marked racial, ethnic, socioeconomic, and geographic disparities in risk of LEA persist and are related to inequalities in access to care and differential rates of attempted limb preservation. Multidisciplinary diabetic foot care (MDFC) is increasingly recognized as a necessary model for optimal management of patients with diabetic foot and vascular disease. This article reviews the role of MDFC in reducing major LEAs and the specific ways in which MDFC can mitigate disparities in care delivery and limb preservation outcomes. Access to MDFC among vulnerable populations remains a significant barrier to systematic reduction in major LEAs.


Assuntos
Diabetes Mellitus , Pé Diabético , Doença Arterial Periférica , Humanos , Pé Diabético/diagnóstico , Pé Diabético/cirurgia , Amputação Cirúrgica , Extremidade Inferior/irrigação sanguínea , Doença Arterial Periférica/diagnóstico , Doença Arterial Periférica/cirurgia , Incidência
8.
Semin Vasc Surg ; 36(1): 39-48, 2023 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-36958896

RESUMO

Racial, ethnic, socioeconomic, and geographic disparities in limb preservation and nontraumatic lower extremity amputation (LEA) are consistently demonstrated in populations with diabetes and peripheral artery disease (PAD). Higher rates of major LEA in disadvantaged groups are associated with increased health care utilization and higher costs of care. Functional decline that often follows major LEA confers substantial risk of disability and premature mortality, and the burden of these outcomes is more prevalent in racial and ethnic minority groups, people with low socioeconomic status, and people in geographic regions where limited resources or distance from specialty care are barriers to access. We present a narrative review of the existing literature on estimated costs of diabetic foot disease and PAD, inequalities in care that contribute to excess costs, and disparities in outcomes that lead to a disproportionate burden of diabetes- and PAD-related LEA on systematically disadvantaged populations.


Assuntos
Diabetes Mellitus , Pé Diabético , Doença Arterial Periférica , Humanos , Estados Unidos/epidemiologia , Fatores de Risco , Etnicidade , Grupos Minoritários , Doença Arterial Periférica/diagnóstico , Doença Arterial Periférica/cirurgia , Pé Diabético/diagnóstico , Pé Diabético/epidemiologia , Pé Diabético/cirurgia , Extremidade Inferior/irrigação sanguínea , Fatores Socioeconômicos
10.
Front Endocrinol (Lausanne) ; 14: 1157518, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37293494

RESUMO

Background: Regular clinical assessment is critical to optimize lower extremity wound healing. However, family and work obligations, socioeconomic, transportation, and time barriers often limit patient follow-up. We assessed the feasibility of a novel, patient-centered, remote wound management system (Healthy.io Minuteful for Wound Digital Management System) for the surveillance of lower extremity wounds. Methods: We enrolled 25 patients from our outpatient multidisciplinary limb preservation clinic with a diabetic foot ulcer, who had undergone revascularization and podiatric interventions prior to enrollment. Patients and their caregivers were instructed on how to use the digital management system and asked to perform one at-home wound scan per week for a total of 8 weeks using a smartphone application. We collected prospective data on patient engagement, smartphone app useability, and patient satisfaction. Results: Twenty-five patients (mean age 65.5 ± 13.7 years, 60.0% male, 52.0% Black) were enrolled over 3 months. Mean baseline wound area was 18.0 ± 15.2 cm2, 24.0% of patients were recovering from osteomyelitis, and post-surgical WiFi stage was 1 in 24.0%, 2 in 40.0%, 3 in 28.0%, and 4 in 8.00% of patients. We provided a smartphone to 28.0% of patients who did not have access to one that was compatible with the technology. Wound scans were obtained by patients (40.0%) and caregivers (60.0%). Overall, 179 wound scans were submitted through the app. The mean number of wound scans acquired per patient was 0.72 ± 0.63 per week, for a total mean of 5.80 ± 5.30 scans over the course of 8 weeks. Use of the digital wound management system triggered an early change in wound management for 36.0% of patients. Patient satisfaction was high; 94.0% of patients reported the system was useful. Conclusion: The Healthy.io Minuteful for Wound Digital Management System is a feasible means of remote wound monitoring for use by patients and/or their caregivers.


Assuntos
Diabetes Mellitus , Pé Diabético , Humanos , Masculino , Pessoa de Meia-Idade , Idoso , Feminino , Pé Diabético/diagnóstico , Pé Diabético/terapia , Estudos Prospectivos , Cicatrização , Amputação Cirúrgica , Assistência Centrada no Paciente
11.
J Thorac Cardiovasc Surg ; 154(4): 1224-1232.e1, 2017 10.
Artigo em Inglês | MEDLINE | ID: mdl-28712578

RESUMO

OBJECTIVE: To comprehensively evaluate and compare utilization, outcomes, and especially costs of transfemoral (TF), transapical (TA), and transaortic (TAO) transcatheter aortic valve replacement (TAVR). METHODS: All Medicare fee-for-service patients undergoing TF (n = 4065), TA (n = 691), or TAO (n = 274) TAVR between January 1, 2011, and November 30, 2012, were identified using Health Care Procedure Classification Codes present on Medicare claims. Hospital charges from Medicare claims were converted to costs using hospital-specific Medicare cost-to-charge ratios. RESULTS: TA and TAO patients were similar in age, race, and common comorbidities. Compared with TF patients, TA and TAO patients were more likely to be female and to have peripheral vascular disease, chronic lung disease, and renal failure. Thirty-day mortality rates were higher among TA and TAO patients than among TF patients (TA, 9.6%; TAO, 8.0%; TF, 5.0%; P < .001). Adjusted mortality beyond 1 year did not differ by access. TA patients were more likely to require cardiopulmonary bypass (CPB). Increased adjusted mortality was associated with CPB (hazard ratio, 2.13; P < .01) and increased 30-day cost ($62,000 [interquartile range (IQR)], $45,100-$86,400 versus $48,800 [IQR, $38,100-$62,900]; P < .01). Cost at 30 days was lowest for TF ($48,600) compared with TA ($49,800; P < .01) and TAO ($53,200; P = .03). CONCLUSIONS: For patients ineligible to receive TF TAVR, TAO and TA approaches offer similar clinical outcomes at similar cost with acceptable operative and 1-year survival, except for higher rates of CPB use in TA patients. CPB was associated with worse survival and increased costs.


Assuntos
Estenose da Valva Aórtica , Cateterismo Periférico , Artéria Femoral/cirurgia , Substituição da Valva Aórtica Transcateter , Idoso , Idoso de 80 Anos ou mais , Aorta/cirurgia , Estenose da Valva Aórtica/economia , Estenose da Valva Aórtica/mortalidade , Estenose da Valva Aórtica/cirurgia , Cateterismo Periférico/métodos , Cateterismo Periférico/estatística & dados numéricos , Custos e Análise de Custo , Feminino , Humanos , Masculino , Medicare/economia , Medicare/estatística & dados numéricos , Avaliação de Processos e Resultados em Cuidados de Saúde , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Análise de Sobrevida , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/economia , Substituição da Valva Aórtica Transcateter/métodos , Substituição da Valva Aórtica Transcateter/estatística & dados numéricos , Resultado do Tratamento , Estados Unidos/epidemiologia
12.
Ann Thorac Surg ; 102(2): 489-95, 2016 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-27130248

RESUMO

BACKGROUND: The aim of this study was to evaluate institutional volume-outcome relationships in extracorporeal membrane oxygenation (ECMO) with subanalyses of ECMO in patients with a primary diagnosis of respiratory failure. METHODS: All institutions with adult ECMO discharges in the Nationwide Inpatient Sample from 2002 to 2011 were evaluated. International Classification of Diseases (ninth revision) codes were used to identify ECMO-treated patients, indications, and concurrent procedures. Patients who were treated with ECMO after cardiotomy were excluded. Annual institutional and national volume of ECMO hospitalizations varied widely, hence the number of ECMO cases performed at an institution was calculated for each year independently. Institutions were grouped into high-, medium-, and low-volume terciles by year. Statistical analysis included hierarchical, multivariable logistic regression. RESULTS: The in-hospital mortality rates for ECMO admissions at low-, medium-, and high-volume ECMO centers were 48% (n = 467), 60% (n = 285), and 57% (n = 445), respectively (p = 0.001). In post hoc pairwise comparisons, patients in low-volume hospitals were more likely to survive to discharge compared with patients in medium-volume (p = 0.001) and high-volume (p = 0.005) hospitals. There was no significant difference in survival between medium-volume and high-volume hospitals (p = 0.81). In a subanalysis of patients with respiratory failure, low-volume ECMO centers maintained the lowest rates of in-hospital mortality (47%), versus 61% in medium-volume institutions (p = 0.045) and 56% in high-volume institutions (p = 0.15). Multivariable logistical regression produced similar results in the entire study sample and in patients with respiratory failure. CONCLUSIONS: ECMO outcomes in the Nationwide Inpatient Sample do not follow a traditional volume-outcome relationship, and these results suggest that, in properly selected patients, ECMO can be performed with acceptable results in U.S. centers that do not perform a high volume of ECMO.


Assuntos
Oxigenação por Membrana Extracorpórea/métodos , Hospitais com Alto Volume de Atendimentos/estatística & dados numéricos , Hospitais com Baixo Volume de Atendimentos/normas , Insuficiência Respiratória/terapia , Feminino , Seguimentos , Mortalidade Hospitalar/tendências , Humanos , Masculino , Pessoa de Meia-Idade , Seleção de Pacientes , Insuficiência Respiratória/mortalidade , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Estados Unidos/epidemiologia
13.
Ann Thorac Surg ; 102(4): 1199-205, 2016 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-27261085

RESUMO

BACKGROUND: There is growing interest in aortic valve-sparing and valve repair operations, but the ideal operation and timing of intervention in these generally younger patients undergoing operations for aortic insufficiency (AI) and dilated ascending aorta remains controversial. METHODS: Root replacements at a single institution from 2002 to 2014 were reviewed. Inclusion criteria were age younger than 70 and presence of moderate or greater aortic insufficiency (AI), with or without aortic aneurysm. Of 1,425 root replacements, 220 patients were considered in the final analysis. RESULTS: Moderate AI was present in 87 patients and severe AI in 133 patients. The 30-day mortality was 0% in moderate AI patients and 2% (n = 3) in severe AI patients (p = 0.3). Freedom from reoperation was 95% at 10 years. Severe preoperative AI was associated with worse long-term survival compared with moderate AI (hazard ratio, 2.6; p = 0.04). Patients undergoing root replacement with moderate AI had similar survival compared with the age- and gender-matched United States population (log-rank p = 0.93), whereas patients with severe AI had significantly worse survival (log-rank p = 0.02). Other multivariable predictors of decreased long-term survival were age (hazard ratio, 1.1; p = 0.01) and preoperative renal failure (hazard ratio, 6.9; p < 0.01). CONCLUSIONS: Elective root replacement operations in patients younger than 70 are associated with low rates of mortality and reoperation, which should be considered the benchmark operation for aortic valve-sparing or repair operations in similar patients. Worse survival was associated with severe AI and older age, suggesting earlier intervention may be an appropriate therapeutic strategy in selected patients.


Assuntos
Aneurisma da Aorta Torácica/cirurgia , Insuficiência da Valva Aórtica/cirurgia , Implante de Prótese Vascular/métodos , Procedimentos Cirúrgicos Eletivos/métodos , Implante de Prótese de Valva Cardíaca/métodos , Adulto , Aneurisma da Aorta Torácica/diagnóstico , Aneurisma da Aorta Torácica/mortalidade , Insuficiência da Valva Aórtica/diagnóstico , Insuficiência da Valva Aórtica/mortalidade , Implante de Prótese Vascular/mortalidade , Causas de Morte , Bases de Dados Factuais , Procedimentos Cirúrgicos Eletivos/mortalidade , Feminino , Seguimentos , Implante de Prótese de Valva Cardíaca/mortalidade , Mortalidade Hospitalar/tendências , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/mortalidade , Complicações Pós-Operatórias/fisiopatologia , Estudos Retrospectivos , Medição de Risco , Análise de Sobrevida , Resultado do Tratamento
14.
Circ Cardiovasc Interv ; 8(9): e002234, 2015 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-26286740

RESUMO

BACKGROUND: Transcatheter aortic valve replacement (TAVR) was approved by the Food and Drug Administration (FDA) in November 2011 after a collaborative technology development process involving professional medical societies, the medical device industry, and the FDA. After FDA approval, TAVR was adopted by numerous hospitals that had not participated in TAVR clinical trials. It is uncertain if outcomes at these hospitals were comparable with those at clinical trial hospitals. METHODS AND RESULTS: All patients with Medicare physician claims for TAVR between January 1, 2011, and November 30, 2012, were identified, and postoperative mortality was assessed using Medicare enrollment data. Risk-adjusted mortality was calculated via a multivariable model that adjusted for demographics and comorbidities. We identified 5009 patients who underwent TAVR, with 3617 TAVRs performed at 68 hospitals that had participated in clinical trials and 1392 TAVRs performed at 140 nontrial hospitals. The preoperative characteristics of patients at trial versus nontrial hospitals were similar. There were no significant differences in risk-adjusted 30-day mortality (5.9% versus 5.6%, odds ratio, 0.88; 95% confidence interval, 0.66-1.15; P=0.34) or 180-day mortality (16.5% versus 15.8%, odds ratio, 0.99; 95% confidence interval, 0.75-1.3; P=0.94). CONCLUSIONS: Patients undergoing TAVR at nontrial hospitals had comparable clinical outcomes to patients undergoing TAVR at clinical trial hospitals. This finding contrasts with several other cardiovascular devices and procedures for which higher mortality was observed at hospitals that did not participate in clinical trials. The unique policy and regulatory environment governing TAVR adoption by hospitals may have contributed to better outcomes during the technology diffusion process.


Assuntos
Ensaios Clínicos como Assunto , Substituição da Valva Aórtica Transcateter/mortalidade , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Curva de Aprendizado , Masculino , Medicare , Readmissão do Paciente/estatística & dados numéricos , Complicações Pós-Operatórias/epidemiologia , Estudos Retrospectivos , Acidente Vascular Cerebral/epidemiologia , Estados Unidos/epidemiologia
15.
Ann Thorac Surg ; 100(5): 1660-4; discussion 1665, 2015 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-26209488

RESUMO

BACKGROUND: Recent reports indicate an increased prevalence and earlier onset of pump thrombosis and associated pump exchanges after left ventricular assist device (LVAD) implantation. Questions remain regarding the current rate and clinical effect of pump exchanges. METHODS: All United States Medicare fee-for-service patients undergoing LVAD implantations (n = 3,166) between January 2009 and December 2012 were identified by procedural codes present on carrier claims collected by the Centers for Medicare & Medicaid Services. Pump exchange, pump removal, heart transplantation, and death were collected from subsequent carrier claim and denominator files. Comorbidities present before implantation were generated using the Elixhauser comorbidity index. RESULTS: Compared with patients who received LVADs before March 1, 2011, LVAD recipients after March 1, 2011, were older on average (63.9 vs 62.2 years, p < 0.01), more likely to be male (82.3% vs. 79.4%, p = 0.04), and had a higher incidence of common comorbidities. The later cohort had higher occurrence of pump exchange by Kaplan-Meier time-to-event estimates and Fisher exact tests at 3 months (1.8 vs 0.8, p = 0.02), 6 months (3.3 vs 1.0, p < 0.01), and 12 months (4.9 vs 2.2, p < 0.01). Cox regression analysis found time-dependent pump exchange was associated with worse survival (hazard ratio, 2.5; 95% confidence interval, 1.8 to 3.62; p < 0.01) after adjusting for age, gender, and comorbidities. CONCLUSIONS: Although LVAD exchanges remain relatively uncommon, a significant increase in the incidence of the procedure has occurred since March 1, 2011. Pump exchanges are highly associated with death, and further research is required to understand the cause of this disturbing trend and surveillance to determine its trajectory.


Assuntos
Remoção de Dispositivo/estatística & dados numéricos , Planos de Pagamento por Serviço Prestado/economia , Insuficiência Cardíaca/terapia , Coração Auxiliar , Medicare/economia , Idoso , Remoção de Dispositivo/economia , Feminino , Insuficiência Cardíaca/mortalidade , Humanos , Masculino , Pessoa de Meia-Idade , Prognóstico , Falha de Prótese , Estudos Retrospectivos , Taxa de Sobrevida/tendências , Estados Unidos/epidemiologia
16.
Semin Thorac Cardiovasc Surg ; 27(2): 81-8, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-26686427

RESUMO

This study evaluates contemporary trends in the use and outcomes of adult patients undergoing extracorporeal membrane oxygenation (ECMO) in U.S. hospitals. All adult discharges in the Nationwide Inpatient Sample database during the years 2002-2012 that included ECMO were used to estimate the total number of U.S. ECMO hospitalizations (n = 12,407). Diagnostic codes were used to group patients by indication for ECMO use into postcardiotomy, heart transplant, lung transplant, cardiogenic shock, respiratory failure, and cardiopulmonary failure. A Mann-Kendall test was used to examine trends over time using standard statistical techniques for survey data. We found that ECMO use increased significantly from 2002-2012 (P = 0.003), whereas in-hospital mortality rate fluctuated without a significant difference in trend over time. No significant trend was observed in overall ECMO use from 2002-2007, but the use did demonstrate a statistically significant increase from 2007-2012 (P = 0.0028). The highest in-hospital mortality rates were found in the postcardiotomy (57.2%) and respiratory failure (59.2%) groups. Lung and heart transplant groups had the lowest in-hospital mortality rates (44.10% and 45.31%, respectively). The proportion of ECMO use for postcardiotomy decreased from 56.9% in 2002 to 37.9% in 2012 (P = 0.026) and increased for cardiopulmonary failure from 3.9% to 11.1% (P = 0.026). We concluded that ECMO use in the United States increased between 2002 and 2012, driven primarily by increase in national ECMO use beginning in 2007. Mortality rates remained high but stable during this time period. Though there were shifts in relative ECMO use among patient groups, absolute ECMO use increased for all indications over the study period.


Assuntos
Oxigenação por Membrana Extracorpórea/tendências , Padrões de Prática Médica/tendências , Avaliação de Processos em Cuidados de Saúde/tendências , Bases de Dados Factuais , Oxigenação por Membrana Extracorpórea/efeitos adversos , Oxigenação por Membrana Extracorpórea/mortalidade , Oxigenação por Membrana Extracorpórea/estatística & dados numéricos , Feminino , Mortalidade Hospitalar/tendências , Hospitalização/tendências , Humanos , Masculino , Pessoa de Meia-Idade , Seleção de Pacientes , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Estados Unidos
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