RESUMO
AIMS: Catheter-directed treatment (CDT) of acute pulmonary embolism (PE) is entering a growth phase in Europe following a steady increase in the USA in the past decade, but the potential economic impact on European healthcare systems remains unknown. METHODS AND RESULTS: We built two statistical models for the monthly trend of proportion of CDT among patients with severe (intermediate- or high-risk) PE in the USA. The conservative model was based on admission data from the National Inpatient Sample (NIS) 2016-20 and the model reflecting increasing access to advanced treatment from the PERT™ national quality assurance database registry 2018-21. By applying these models to the forecast of annual PE-related hospitalizations in Germany, we calculated the annual number of severe PE cases and the expected increase in CDT use for the period 2025-30. The NIS-based model yielded a slow increase, reaching 3.1% (95% confidence interval 3.0-3.2%) among all hospitalizations with PE in 2030; in the PERT-based model, increase would be steeper, reaching 8.7% (8.3-9.2%). Based on current reimbursement rates, we estimated an increase of annual costs for PE-related hospitalizations in Germany ranging from 15.3 to 49.8 million euros by 2030. This calculation does not account for potential cost savings, including those from reduced length of hospital stay. CONCLUSION: Our approach and results, which may be adapted to other European healthcare systems, provide a benchmark for healthcare costs expected to result from CDT. Data from ongoing trials on clinical benefits and cost savings are needed to determine cost-effectiveness and inform reimbursement decisions.
Assuntos
Embolia Pulmonar , Humanos , Embolia Pulmonar/terapia , Embolia Pulmonar/economia , Embolia Pulmonar/epidemiologia , Estados Unidos/epidemiologia , Europa (Continente)/epidemiologia , Masculino , Feminino , Custos de Cuidados de Saúde/tendências , Custos de Cuidados de Saúde/estatística & dados numéricos , Hospitalização/economia , Hospitalização/tendências , Hospitalização/estatística & dados numéricos , Sistema de Registros , Alemanha/epidemiologia , Pessoa de Meia-Idade , Atenção à Saúde/economia , Atenção à Saúde/tendênciasRESUMO
PURPOSE: To study, from a U.S. payer's perspective, the economic consequences of drug-coated balloon (DCB) versus standard percutaneous transluminal angioplasty (PTA) use for the treatment of stenotic lesions in dysfunctional hemodialysis arteriovenous fistulae. MATERIALS AND METHODS: Cost differences between DCBs and PTA at year 1 and beyond were calculated via 2 methods. The first approach used the mean absolute number of trial-observed access circuit reinterventions through 12 months (0.65 ± 1.05 vs 1.05 ± 1.18 events per patient for DCBs and PTA, respectively) and projected treatment outcomes to 3 years. The second approach was based on the trial-observed access circuit primary patency rates at 12 months (53.8% vs 32.4%) and calculated the cost difference on the basis of previously published Medicare cost for patients who maintained or did not maintain primary patency. Assumptions regarding DCB device prices were tested in sensitivity analyses, and the numbers needed to treat were calculated. RESULTS: Using the absolute number of access circuit reinterventions approach, the DCB strategy resulted in an estimated per-patient savings of $1,632 at 1 year and $4,263 at 3 years before considering the DCB device cost. The access circuit primary patency approach was associated with a per-patient cost savings of $2,152 at 1 year and $3,894 at 2.5 years of follow-up. At the theoretical DCB device reimbursement of $1,800, savings were $1,680 and $2,049 at 2.5 and 3 years, respectively. The one-year NNT of DCB compared to PTA was 2.48. CONCLUSIONS: Endovascular therapy for arteriovenous access stenosis with the IN.PACT AV DCB can be expected to be cost-saving if longer follow-up data confirm its clinical effectiveness.
Assuntos
Angioplastia com Balão , Fístula Arteriovenosa , Doença Arterial Periférica , Idoso , Angioplastia com Balão/economia , Fístula Arteriovenosa/diagnóstico por imagem , Fístula Arteriovenosa/patologia , Fístula Arteriovenosa/terapia , Fármacos Cardiovasculares , Materiais Revestidos Biocompatíveis , Constrição Patológica/patologia , Análise Custo-Benefício , Artéria Femoral , Humanos , Medicare , Paclitaxel , Doença Arterial Periférica/terapia , Artéria Poplítea , Fatores de Tempo , Resultado do Tratamento , Estados Unidos , Grau de Desobstrução VascularRESUMO
BACKGROUND: Few studies have compared long-term outcomes among specific treatment modalities for critical limb ischemia. The aim of this study was to compare long-term outcomes with percutaneous transluminal angioplasty (PTA), stent placement, atherectomy, or surgical bypass in patients diagnosed with critical limb ischemia. METHODS: In this observational study using Medicare claims data, we identified incident cases with a primary critical limb ischemia diagnosis who received PTA, stent placement, atherectomy, or surgical bypass. We used propensity score weighting to determine the association of treatment type with all-cause mortality and major (above ankle) amputation over 4 years follow-up. RESULTS: Among 36 860 patients (10 904 PTA; 11 295 stent placement; 4422 atherectomy; 10 239 surgical bypass), all-cause mortality over 4 years was 49.3% with atherectomy, 51.4% with surgical bypass, 53.7% with stent placement, and 54.7% with PTA (P<0.05 for all pairwise comparisons). Major amputation rates over 4 years were 6.8% with atherectomy, 7.8% with stent placement, 8.1% with PTA, and 10.8% with surgical bypass (P<0.05 for all pairwise comparison except PTA versus stent). CONCLUSIONS: Among Medicare beneficiaries who received PTA, stent placement, atherectomy, or surgical bypass for critical limb ischemia, high mortality and major amputation rates were observed with minor differences among treatment groups. Statistically significant group differences of uncertain clinical importance were observed for several comparisons. Results from observational research may be susceptible to bias because of unmeasured confounders and, therefore, these comparative results should be interpreted with caution.
Assuntos
Angioplastia com Balão , Aterectomia , Isquemia/terapia , Doença Arterial Periférica/terapia , Enxerto Vascular , Demandas Administrativas em Assistência à Saúde , Idoso , Idoso de 80 Anos ou mais , Amputação Cirúrgica , Angioplastia com Balão/efeitos adversos , Angioplastia com Balão/instrumentação , Angioplastia com Balão/mortalidade , Aterectomia/efeitos adversos , Aterectomia/mortalidade , Estado Terminal , Bases de Dados Factuais , Feminino , Humanos , Isquemia/diagnóstico por imagem , Isquemia/mortalidade , Isquemia/fisiopatologia , Salvamento de Membro , Masculino , Medicare , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/mortalidade , Doença Arterial Periférica/fisiopatologia , Pontuação de Propensão , Medição de Risco , Fatores de Risco , Stents , Fatores de Tempo , Resultado do Tratamento , Estados Unidos , Enxerto Vascular/efeitos adversos , Enxerto Vascular/mortalidadeRESUMO
Background The optimal treatment for critical limb ischemia remains controversial owing to conflicting conclusions from previous studies. Methods and Results We obtained administrative claims on Medicare beneficiaries with initial critical limb ischemia diagnosis in 2011. Clinical outcomes and healthcare costs over 4 years were estimated among all patients and by first treatment (endovascular revascularization, surgical revascularization, or major amputation) in unmatched and propensity-score-matched samples. Among 72 199 patients with initial primary critical limb ischemia diagnosis in 2011, survival was 46% (median survival, 3.5 years) and freedom from major amputation was 87%. Among 9942 propensity-score-matched patients (8% rest pain, 26% ulcer, and 66% gangrene), survival was 38% with endovascular revascularization (median survival, 2.7 years), 40% with surgical revascularization (median survival, 2.9 years), and 23% with major amputation (median survival, 1.3 years; P<0.001 for each revascularization procedure versus major amputation). Corresponding major amputation rates were 6.5%, 9.6%, and 10.6%, respectively ( P<0.001 for all pair-wise comparisons). The cost per patient year during follow-up was $49 700, $49 200, and $55 700, respectively ( P<0.001 for each revascularization procedure versus major amputation). Conclusions Long-term survival and cost in critical limb ischemia management is comparable between revascularization techniques, with lower major amputation rates following endovascular revascularization. Primary major amputation results in shorter survival, higher risk of subsequent major amputation, and higher healthcare costs versus revascularization. Results from this observational research may be susceptible to bias because of the influence of unmeasured confounders.
Assuntos
Amputação Cirúrgica/estatística & dados numéricos , Custos de Cuidados de Saúde , Isquemia/terapia , Doença Arterial Periférica/terapia , Procedimentos Cirúrgicos Vasculares/estatística & dados numéricos , Idoso , Idoso de 80 Anos ou mais , Amputação Cirúrgica/economia , Estudos de Coortes , Procedimentos Endovasculares/economia , Procedimentos Endovasculares/estatística & dados numéricos , Extremidades/irrigação sanguínea , Feminino , Gangrena/economia , Gangrena/terapia , Humanos , Isquemia/economia , Masculino , Medicare , Doença Arterial Periférica/economia , Pontuação de Propensão , Estudos Retrospectivos , Taxa de Sobrevida , Resultado do Tratamento , Estados Unidos , Procedimentos Cirúrgicos Vasculares/economiaAssuntos
Angioplastia com Balão/economia , Angioplastia com Balão/instrumentação , Centers for Medicare and Medicaid Services, U.S./economia , Materiais Revestidos Biocompatíveis/economia , Custos de Cuidados de Saúde , Doença Arterial Periférica/economia , Doença Arterial Periférica/cirurgia , Mecanismo de Reembolso/economia , Dispositivos de Acesso Vascular , Angioplastia com Balão/legislação & jurisprudência , Centers for Medicare and Medicaid Services, U.S./legislação & jurisprudência , Medicina Baseada em Evidências/economia , Regulamentação Governamental , Custos de Cuidados de Saúde/legislação & jurisprudência , Humanos , Doença Arterial Periférica/diagnóstico , Formulação de Políticas , Mecanismo de Reembolso/legislação & jurisprudência , Estados Unidos , Dispositivos de Acesso Vascular/economiaAssuntos
Procedimentos Endovasculares , Isquemia/terapia , Extremidade Inferior/irrigação sanguínea , Medicare , Doença Arterial Periférica/terapia , Enxerto Vascular , Idoso , Amputação Cirúrgica , Estado Terminal , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/mortalidade , Humanos , Isquemia/diagnóstico , Isquemia/mortalidade , Salvamento de Membro , Doença Arterial Periférica/diagnóstico , Doença Arterial Periférica/mortalidade , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Estados Unidos/epidemiologia , Enxerto Vascular/efeitos adversos , Enxerto Vascular/mortalidadeRESUMO
OBJECTIVE: The current state of evaluating patients with peripheral artery disease and more specifically of evaluating medical devices used for peripheral vascular intervention (PVI) remains challenging because of the heterogeneity of the disease process, the multiple physician specialties that perform PVI, the multitude of devices available to treat peripheral artery disease, and the lack of consensus about the best treatment approaches. Because PVI core data elements are not standardized across clinical care, clinical trials, and registries, aggregation of data across different data sources and physician specialties is currently not feasible. METHODS: Under the auspices of the U.S. Food and Drug Administration's Medical Device Epidemiology Network initiative-and its PASSION (Predictable and Sustainable Implementation of the National Registries) program, in conjunction with other efforts to align clinical data standards-the Registry Assessment of Peripheral Interventional Devices (RAPID) workgroup was convened. RAPID is a collaborative, multidisciplinary effort to develop a consensus lexicon and to promote interoperability across clinical care, clinical trials, and national and international registries of PVI. RESULTS: The current manuscript presents the initial work from RAPID to standardize clinical data elements and definitions, to establish a framework within electronic health records and health information technology procedural reporting systems, and to implement an informatics-based approach to promote the conduct of pragmatic clinical trials and registry efforts in PVI. CONCLUSIONS: Ultimately, we hope this work will facilitate and improve device evaluation and surveillance for patients, clinicians, health outcomes researchers, industry, policymakers, and regulators.
Assuntos
Prótese Vascular , Aprovação de Equipamentos/normas , Procedimentos Endovasculares/instrumentação , Doença Arterial Periférica/terapia , Sistema de Registros/normas , Stents , United States Food and Drug Administration/normas , Procedimentos Cirúrgicos Vasculares/instrumentação , Mineração de Dados/normas , Registros Eletrônicos de Saúde/normas , Procedimentos Endovasculares/efeitos adversos , Humanos , Cooperação Internacional , Informática Médica/normas , Doença Arterial Periférica/diagnóstico , Doença Arterial Periférica/fisiopatologia , Vigilância de Produtos Comercializados/normas , Desenho de Prótese , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Estados Unidos/epidemiologia , Procedimentos Cirúrgicos Vasculares/efeitos adversos , Fluxo de TrabalhoRESUMO
Our objective was to compare plaque volumes of multidetector computed tomographic images reconstructed using adaptive statistical iterative reconstruction (ASIR), model-based iterative reconstruction (MBIR), and filtered back projection (FBP). We reviewed 25 patients for a total of 50 extremities imaged on the same scanner. Calcified plaque FBP volume (3468.2 ± 2634.8 mm(3)) was higher than ASIR (2548.1 ± 2166.5 mm(3)). Calcified plaque FBP volume was higher than MBIR (mean=2345.7 ± 1935.4 mm(3)). Our findings suggest that traditional FBP methods overestimate disease compared to newer reconstruction methods.
Assuntos
Algoritmos , Efeitos Psicossociais da Doença , Tomografia Computadorizada Multidetectores/métodos , Interpretação de Imagem Radiográfica Assistida por Computador/métodos , Interface Usuário-Computador , Calcificação Vascular/diagnóstico por imagem , Angiografia/métodos , Humanos , Iopamidol , Doença Arterial Periférica/diagnóstico por imagem , Intensificação de Imagem Radiográfica/métodos , Reprodutibilidade dos Testes , Estudos Retrospectivos , Sensibilidade e EspecificidadeRESUMO
Peripheral artery disease is increasingly prevalent with disease presentations ranging from the asymptomatic patient to the patient with an ischemic or threatened lower extremity. The role of the vascular specialist treating the peripheral artery disease patient is to create or maintain straight-line or uninterrupted blood flow to the extremities in order to preserve patient mobility and the ability of the leg to heal in the setting of trauma or infection. Although autologous-vein surgical bypass grafting has long been viewed as the first-line treatment, endovascular approaches have become increasingly popular owing to technological advances, including the advent of drug-eluting stents. The angiographic and clinical results including symptom improvement, wound healing, limb salvage rates, cost considerations and current ongoing clinical research will be discussed.