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1.
Arq. bras. cardiol ; 112(1): 40-47, Jan. 2019. tab, graf
Article in English | LILACS | ID: biblio-973839

ABSTRACT

Abstract Background: In multivessel disease patients with moderate stenosis, fractional flow reserve (FFR) allows the analysis of the lesions and guides treatment, and could contribute to the cost-effectiveness (CE) of non-pharmacological stents (NPS). Objectives: To evaluate CE and clinical impact of FFR-guided versus angiography-guided angioplasty (ANGIO) in multivessel patients using NPS. Methods: Multivessel disease patients were prospectively randomized to FFR or ANGIO groups during a 5 year-period and followed for < 12 months. Outcomes measures were major adverse cardiac events (MACE), restenosis and CE. Results: We studied 69 patients, 47 (68.1%) men, aged 62.0 ± 9.0 years, 34 (49.2%) in FFR group and 53 (50.7%) in ANGIO group, with stable angina or acute coronary syndrome. In FFR, there were 26 patients with biarterial disease (76.5%) and 8 (23.5%) with triarterial disease, and in ANGIO, 24 (68.6%) with biarterial and 11 (31.4%) with triarterial disease. Twelve MACEs were observed - 3 deaths: 2 (5.8%) in FFR and 1 (2.8%) in ANGIO, 9 (13.0%) angina: 4(11.7%) in FFR and 5(14.2%) in ANGIO, 6 restenosis: 2(5.8%) in FFR and 4 (11.4%) in ANGIO. Angiography detected 87(53.0%) lesions in FFR, 39(23.7%) with PCI and 48(29.3%) with medical treatment; and 77 (47.0%) lesions in ANGIO, all treated with angioplasty. Thirty-nine (33.3%) stents were registered in FFR (0.45 ± 0.50 stents/lesion) and 78 (1.05 ± 0.22 stents/lesion) in ANGIO (p = 0.0001), 51.4% greater in ANGIO than FFR. CE analysis revealed a cost of BRL 5,045.97 BRL 5,430.60 in ANGIO and FFR, respectively. The difference of effectiveness was of 1.82%. Conclusion: FFR reduced the number of lesions treated and stents, and the need for target-lesion revascularization, with a CE comparable with that of angiography.


Resumo Fundamentos: Em pacientes multiarteriais e lesões moderadas, a reserva de fluxo fracionada (FFR) avalia cada lesão e direciona o tratamento, podendo ser útil no custo-efetividade (CE) de implante de stents não farmacológicos (SNF). Objetivos: Avaliar CE e impacto clínico da angioplastia + FFR versus angioplastia + angiografia (ANGIO), em multiarteriais, utilizando SNF. Métodos: pacientes com doença multiarteriais foram randomizados prospectivamente durante ±5 anos para FFR ou ANGIO, e acompanhados por até 12 meses. Foram avaliados eventos cardíacos maiores (ECAM), reestenose e CE. Resultados: foram incluídos 69 pacientes, 47(68,1%) homens, 34(49,2%) no FFR e 35(50,7%) no ANGIO, idade 62,0 ± 9,0 anos, com angina estável e Síndrome Coronariana Aguda estabilizada. No FFR, havia 26 com doença (76,5%) biarterial e 8 (23,5%) triarterial, e no grupo ANGIO, 24(68,6%) biarteriais e 11(31,4%) triarteriais. Ocorreram 12(17,3%) ECAM - 3(4,3%) óbitos: 2(5,8%) no FFR e 1(2,8%) no ANGIO, 9(13,0%) anginas, 4(11,7%) no FFR e 5(14,2%) no ANGIO, 6 reestenoses: 2(5,8%) no FFR e 4 (11,4%) no ANGIO. Angiografia detectou 87(53,0%) lesões no FFR, 39(23,7%) com ICP e 48(29,3%) com tratamento clínico; e 77(47,0%) lesões no ANGIO, todas submetidas à angioplastia. Quanto aos stents, registrou-se 39(33,3%) (0,45 ± 0,50 stents/lesão) no FFR e 78(66,6%) (1,05 ± 0,22 stents/lesão) no ANGIO (p = 0,0001); ANGIO utilizou 51,4% a mais que o FFR. Análise de CE revelou um custo de R$5045,97 e R$5.430,60 nos grupos ANGIO e FFR, respectivamente. A diferença de efetividade foi 1,82%. Conclusões: FFR diminuiu o número de lesões tratadas e de stents e necessidade de revascularização do vaso-alvo, com CE comparável ao da angiografia.


Subject(s)
Humans , Male , Female , Middle Aged , Aged , Angioplasty, Balloon, Coronary/methods , Coronary Angiography/methods , Fractional Flow Reserve, Myocardial/physiology , Acute Coronary Syndrome/therapy , Angina, Stable/therapy , Time Factors , Angioplasty, Balloon, Coronary/economics , Stents , Prospective Studies , Treatment Outcome , Coronary Angiography/economics , Cost-Benefit Analysis , Statistics, Nonparametric , Coronary Restenosis/mortality , Coronary Restenosis/therapy , Kaplan-Meier Estimate , Acute Coronary Syndrome/economics , Acute Coronary Syndrome/pathology , Angina, Stable/economics , Angina, Stable/mortality
2.
Arq Bras Cardiol ; 112(1): 40-47, 2019 01.
Article in English, Portuguese | MEDLINE | ID: mdl-30570071

ABSTRACT

BACKGROUND: In multivessel disease patients with moderate stenosis, fractional flow reserve (FFR) allows the analysis of the lesions and guides treatment, and could contribute to the cost-effectiveness (CE) of non-pharmacological stents (NPS). OBJECTIVES: To evaluate CE and clinical impact of FFR-guided versus angiography-guided angioplasty (ANGIO) in multivessel patients using NPS. METHODS: Multivessel disease patients were prospectively randomized to FFR or ANGIO groups during a 5 year-period and followed for < 12 months. Outcomes measures were major adverse cardiac events (MACE), restenosis and CE. RESULTS: We studied 69 patients, 47 (68.1%) men, aged 62.0 ± 9.0 years, 34 (49.2%) in FFR group and 53 (50.7%) in ANGIO group, with stable angina or acute coronary syndrome. In FFR, there were 26 patients with biarterial disease (76.5%) and 8 (23.5%) with triarterial disease, and in ANGIO, 24 (68.6%) with biarterial and 11 (31.4%) with triarterial disease. Twelve MACEs were observed - 3 deaths: 2 (5.8%) in FFR and 1 (2.8%) in ANGIO, 9 (13.0%) angina: 4(11.7%) in FFR and 5(14.2%) in ANGIO, 6 restenosis: 2(5.8%) in FFR and 4 (11.4%) in ANGIO. Angiography detected 87(53.0%) lesions in FFR, 39(23.7%) with PCI and 48(29.3%) with medical treatment; and 77 (47.0%) lesions in ANGIO, all treated with angioplasty. Thirty-nine (33.3%) stents were registered in FFR (0.45 ± 0.50 stents/lesion) and 78 (1.05 ± 0.22 stents/lesion) in ANGIO (p = 0.0001), 51.4% greater in ANGIO than FFR. CE analysis revealed a cost of BRL 5,045.97 BRL 5,430.60 in ANGIO and FFR, respectively. The difference of effectiveness was of 1.82%. CONCLUSION: FFR reduced the number of lesions treated and stents, and the need for target-lesion revascularization, with a CE comparable with that of angiography.


Subject(s)
Acute Coronary Syndrome/therapy , Angina, Stable/therapy , Angioplasty, Balloon, Coronary/methods , Coronary Angiography/methods , Fractional Flow Reserve, Myocardial/physiology , Acute Coronary Syndrome/economics , Acute Coronary Syndrome/pathology , Aged , Angina, Stable/economics , Angina, Stable/mortality , Angioplasty, Balloon, Coronary/economics , Coronary Angiography/economics , Coronary Restenosis/mortality , Coronary Restenosis/therapy , Cost-Benefit Analysis , Female , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Prospective Studies , Statistics, Nonparametric , Stents , Time Factors , Treatment Outcome
3.
J Comp Eff Res ; 7(5): 471-481, 2018 05.
Article in English | MEDLINE | ID: mdl-29376402

ABSTRACT

AIM: Study was aimed to assess the real-world costs of manual thrombectomy (MT) in selected ST-segment elevation myocardial infarction patients with intracoronary thrombus (IT). METHODS: Study group (IT+) comprised 51 patients with MT applied and control group (IT-) comprised 56 patients without IT who underwent angioplasty alone. Costs comprised hospital care and cost of disposable materials used during primary angioplasty. RESULTS: Complex management of patients with IT is more expensive, though allows to achieve clinical outcomes comparable to low-risk ST-segment elevation myocardial infarction patients without IT. CONCLUSION: A complex pharmaco-interventional strategy, with glycoprotein IIB/IIIA inhibitor and MT, though more expensive, may prove cost-effective.


Subject(s)
Coronary Thrombosis/surgery , Myocardial Infarction/therapy , Thrombectomy/economics , Thrombectomy/methods , Aged , Angioplasty, Balloon, Coronary/economics , Angioplasty, Balloon, Coronary/methods , Case-Control Studies , Combined Modality Therapy , Coronary Angiography , Coronary Thrombosis/complications , Coronary Thrombosis/diagnostic imaging , Female , Humans , Male , Middle Aged , Myocardial Infarction/complications , Myocardial Infarction/diagnostic imaging , ST Elevation Myocardial Infarction/complications , ST Elevation Myocardial Infarction/therapy , Treatment Outcome
6.
Kardiol Pol ; 75(9): 914-921, 2017.
Article in English | MEDLINE | ID: mdl-28541592

ABSTRACT

BACKGROUND: Costs of percutaneous coronary interventions (PCI) have an important impact on health care expenditures. Despite the present stress upon the cost-effectiveness issues in medicine, few comprehensive data exist on costs and resource use in different clinical settings. AIM: To assess catheterisation laboratory costs related to use of drugs and single-use devices in patients undergoing PCI due to coronary artery disease. METHODS: Retrospective analysis of 1500 consecutive PCIs (radial approach, n = 1103; femoral approach, n = 397) performed due to ST segment elevation myocardial infarction (STEMI; n = 345) and non ST-segment elevation myocardial infarction (NSTEMI; n = 426) as well as unstable angina (UA; n = 489) and stable angina (SA; n = 241) was undertaken. Comparative cost analysis was performed and shown in local currency units (PLN). RESULTS: The cath lab costs were higher in STEMI (4295.01 ± 2384.54PLN, p < 0.001) compared to NSTEMI (3493.40 ± 1907.43 PLN, p < 0.001), UA (3206.31 ± 1692.82 PLN, p < 0.001) and SA patients (3138.91 ± 1427.62 PLN, p < 0.001). They were higher in males than in females (3668.9 ± 2095.2 vs. 3292.0 ± 1656.0 PLN, p < 0.05). In females PCIs performed via radial approach were more expensive than via femoral approach (3360.4 ± 1540.1 vs. 3135.5 ± 1890.3 PLN, p < 0.01). In all subgroups analysed, costs were positively correlated with X-ray dose, fluoroscopy, and total procedure times. Patients' age negatively correlated with cath lab costs in STEMI/NSTEMI patients. CONCLUSIONS: Cath lab costs were higher in STEMI patients compared to other groups. In STEMI/NSTEMI they were lower in older patients. In all analysed groups costs were related to the level of procedural difficulty. In female patients, the costs of PCI performed via radial approach were higher compared to femoral approach. Despite younger age, male patients underwent more expensive procedures.


Subject(s)
Angina, Stable/therapy , Angina, Unstable/therapy , Angioplasty, Balloon, Coronary/economics , Non-ST Elevated Myocardial Infarction/therapy , ST Elevation Myocardial Infarction/therapy , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , Retrospective Studies , Sex Factors
7.
Dtsch Med Wochenschr ; 141(2): 133-6, 2016 Jan.
Article in German | MEDLINE | ID: mdl-26800075

ABSTRACT

Pay-for-performance in German health care system is still uncommon but--in view of scheduled legislative projects--could gain more influence in future. Beside others, risc adjusted in-hospital mortality and the door-to-ballon-time inpatients with ST-elevation myocardial infarction could become quality- and performance indicators in interventional cardiology units. As a result, process optimization based on these indicators could have an impact on both patient value (as already today) and revenues (from 2017 onwards).


Subject(s)
Angioplasty, Balloon, Coronary/economics , Coronary Care Units/economics , Reimbursement, Incentive , Germany , Hospital Mortality , Humans
8.
Bull Acad Natl Med ; 200(3): 497-512; discussion 512-3, 2016 03.
Article in French | MEDLINE | ID: mdl-28644600

ABSTRACT

There are major geographic disparities in the practice of coronary angioplasty and coronarography in France. Their study shows that the frequency of these procedures is linked to the density of private medical practice (cardiologist's offices or clinics). This is not observed as far as coronary artery bypass surgery is concerned. This indicates an induction effect from simply on demand. However, this cannot give indication on the pertinence of those acts since this induction effect may as well be beneficial to patients. Nevertheless, this study gives an insight to the regulatory authorities (Regional Health Agencies and the National "Direction Générale de l'Offre de Soins") which have to manage health care system performance on the basis of the principles set out and international guidelines so as to provide equal access for all to a quality healthcare system.


Subject(s)
Angioplasty, Balloon, Coronary/statistics & numerical data , Coronary Angiography/statistics & numerical data , Coronary Artery Bypass/statistics & numerical data , Healthcare Disparities , Angioplasty, Balloon, Coronary/economics , Coronary Angiography/economics , Coronary Artery Bypass/economics , France/epidemiology , Geography , Health Care Costs , Health Services Accessibility , Healthcare Disparities/statistics & numerical data , Hospitalization/statistics & numerical data , Humans , Practice Patterns, Physicians'/economics , Practice Patterns, Physicians'/statistics & numerical data
9.
Arq Bras Cardiol ; 105(4): 339-44, 2015 Oct.
Article in English, Portuguese | MEDLINE | ID: mdl-26559980

ABSTRACT

BACKGROUND: Acute coronary syndrome (ACS) is defined as a "group of clinical symptoms compatible with acute myocardial ischemia", representing the leading cause of death worldwide, with a high clinical and financial impact. In this sense, the development of economic studies assessing the costs related to the treatment of ACS should be considered. OBJECTIVE: To evaluate costs and length of hospital stay between groups of patients treated for ACS undergoing angioplasty with or without stent implantation (stent+ / stent-), coronary artery bypass surgery (CABG) and treated only clinically (Clinical) from the perspective of the Brazilian Supplementary Health System (SHS). METHODS: A retrospective analysis of medical claims of beneficiaries of health plans was performed considering hospitalization costs and length of hospital stay for management of patients undergoing different types of treatment for ACS, between Jan/2010 and Jun/2012. RESULTS: The average costs per patient were R$ 18,261.77, R$ 30,611.07, R$ 37,454.94 and R$ 40,883.37 in the following groups: Clinical, stent-, stent+ and CABG, respectively. The average costs per day of hospitalization were R$ 1,987.03, R$ 4,024.72, R$ 6,033.40 and R$ 2,663.82, respectively. The average results for length of stay were 9.19 days, 7.61 days, 6.19 days and 15.20 days in these same groups. The differences were significant between all groups except Clinical and stent- and between stent + and CABG groups for cost analysis. CONCLUSION: Hospitalization costs of SCA are high in the Brazilian SHS, being significantly higher when interventional procedures are required.


Subject(s)
Acute Coronary Syndrome/therapy , Angioplasty, Balloon, Coronary/economics , Coronary Artery Bypass/economics , Health Expenditures , Health Maintenance Organizations/economics , Acute Coronary Syndrome/economics , Aged , Brazil , Female , Hospitalization/economics , Humans , Male , Middle Aged , Retrospective Studies , Statistics, Nonparametric , Stents/economics , Time Factors
10.
Arq. bras. cardiol ; 105(4): 339-344, tab, graf
Article in English | LILACS | ID: lil-764465

ABSTRACT

AbstractBackground:Acute coronary syndrome (ACS) is defined as a “group of clinical symptoms compatible with acute myocardial ischemia”, representing the leading cause of death worldwide, with a high clinical and financial impact. In this sense, the development of economic studies assessing the costs related to the treatment of ACS should be considered.Objective:To evaluate costs and length of hospital stay between groups of patients treated for ACS undergoing angioplasty with or without stent implantation (stent+ / stent-), coronary artery bypass surgery (CABG) and treated only clinically (Clinical) from the perspective of the Brazilian Supplementary Health System (SHS).Methods:A retrospective analysis of medical claims of beneficiaries of health plans was performed considering hospitalization costs and length of hospital stay for management of patients undergoing different types of treatment for ACS, between Jan/2010 and Jun/2012.Results:The average costs per patient were R$ 18,261.77, R$ 30,611.07, R$ 37,454.94 and R$ 40,883.37 in the following groups: Clinical, stent-, stent+ and CABG, respectively. The average costs per day of hospitalization were R$ 1,987.03, R$ 4,024.72, R$ 6,033.40 and R$ 2,663.82, respectively. The average results for length of stay were 9.19 days, 7.61 days, 6.19 days and 15.20 days in these same groups. The differences were significant between all groups except Clinical and stent- and between stent + and CABG groups for cost analysis.Conclusion:Hospitalization costs of SCA are high in the Brazilian SHS, being significantly higher when interventional procedures are required.


Fundamento:Síndrome coronariana aguda (SCA) é definida como um “grupo de sintomas clínicos compatíveis com isquemia miocárdica aguda”, representando a principal causa de óbito no mundo, com elevado impacto clínico e financeiro. Nesse sentido, o desenvolvimento de estudos econômicos que avaliem os custos despendidos no tratamento da SCA deve ser considerado.Objetivo:Avaliar custos e tempo de internação hospitalar entre grupos de pacientes que trataram SCA, submetidos a procedimentos de angioplastia com ou sem implante de stent (stent+ / stent-), revascularização (Revasc) e tratados apenas clinicamente (Clínico), sob a perspectiva do sistema de saúde suplementar (SSS) brasileiro.Métodos:Realizou-se uma análise retrospectiva de contas médicas de beneficiários de planos de saúde considerando dados de custos de internação e tempo de permanência hospitalar para o manejo de pacientes submetidos a diferentes tipos de tratamento para SCA, no período entre 1/2010 e 6/2012.Resultados:Os custos médios por paciente foram de R$ 18.261,77, R$ 30.611,07, R$ 37.454,94 e R$ 40.883,37 nos grupos Clínico, stent-, stent+ e Revasc, respectivamente. Os custos médios por dia de internação foram de R$ 1.987,03, R$ 4.024,72, R$ 6.033,40 e R$ 2.663,82, respectivamente. Os tempos médios de internação foram de 9,19 dias, 7,61 dias, 6,19 dias e 15,20 dias nesses mesmos grupos. As diferenças foram estatisticamente significativas entre todos os grupos, exceto Clínico e stent- e entre os grupos stent + e Revasc, para a análise de custos.Conclusão:O custo hospitalar da SCA é elevado no SSS brasileiro e significativamente mais alto quando há a necessidade da realização de procedimentos intervencionistas.


Subject(s)
Aged , Female , Humans , Male , Middle Aged , Acute Coronary Syndrome/therapy , Angioplasty, Balloon, Coronary/economics , Coronary Artery Bypass/economics , Health Expenditures , Health Maintenance Organizations/economics , Acute Coronary Syndrome/economics , Brazil , Hospitalization/economics , Retrospective Studies , Statistics, Nonparametric , Stents/economics , Time Factors
11.
Ther Adv Cardiovasc Dis ; 9(3): 87-94, 2015 Jun.
Article in English | MEDLINE | ID: mdl-25731186

ABSTRACT

OBJECTIVES: The clinical efficacy and safety of drug-coated balloon (DCB) angioplasty in patients with coronary in-stent restenosis (ISR) has been demonstrated. The objective of this article is to provide comparative cost efficacy data for DCB angioplasty in various countries based on the original methodology of the Medical Technologies Evaluation Programme (MTEP) at the National Institute for Health and Clinical Excellence (NICE) in 2010. STUDY DESIGN: Published and unpublished Health Technology Assessment (HTA) reports were evaluated for comparison in selected countries. Furthermore, a systematic review of economic evaluations of DCB angioplasty versus standard treatments (uncoated balloon angioplasty or drug-eluting stent implantations) was conducted. METHODS: National cost efficacy data were evaluated using Markov state transition models which were adapted to fit each country's device and procedure related costs. The clinical input for adverse events was defined with two relevant trials for in-stent restenosis of bare metal stents (BMS-ISR) and of drug-eluting stents (DES-ISR). RESULTS: In the UK, Germany, Switzerland, South Africa, Japan and Brazil, DCB angioplasty is cost-effective when compared with drug-eluting stents to treat either BMS-ISR or DES-ISR. CONCLUSIONS: DCB angioplasty ought to be the preferred treatment option for patients with BMS-ISR and DES-ISR from the payers' point of view.


Subject(s)
Angioplasty, Balloon, Coronary/economics , Coated Materials, Biocompatible/economics , Coronary Restenosis/economics , Coronary Restenosis/therapy , Paclitaxel/economics , Practice Guidelines as Topic , Tubulin Modulators/economics , Angioplasty, Balloon, Coronary/instrumentation , Cost Savings , Cost-Benefit Analysis , Global Health , Humans
12.
Health Aff (Millwood) ; 34(1): 71-7, 2015 Jan.
Article in English | MEDLINE | ID: mdl-25561646

ABSTRACT

Previous research has found that Hospital Compare, Medicare's public reporting initiative, has had little impact on patient outcomes. However, little is known about the initiative's impact on hospital prices, which may be significant because private insurers are generally well positioned to respond to quality information when negotiating prices with hospitals. We estimated difference-in-differences models of the effects of Hospital Compare quality reporting on transaction prices for two major cardiac procedures, coronary artery bypass graft (CABG) and percutaneous coronary intervention (PCI). States that had mandated their own public reporting systems before the implementation of Hospital Compare formed the control group. We found that prices for these procedures continued to increase overall after the initiation of Hospital Compare quality scores, but the rate of increase was significantly lower in states with no quality reporting metrics of their own before Hospital Compare, when compared to the control states (annual rates of increase of 4.4 percent versus 8.7 percent for PCI, and 3.9 percent versus 10.6 percent for CABG, adjusted for overall inflation). This finding implies that Hospital Compare provided leverage to purchasers in moderating price increases, while adding competitive pressures on hospitals. Providing accurate quality information on both hospitals and health plans could benefit consumers.


Subject(s)
Angioplasty, Balloon, Coronary/economics , Coronary Artery Bypass/economics , Costs and Cost Analysis/economics , Costs and Cost Analysis/standards , Health Care Costs/trends , Hospital Charges/trends , Hospital Costs/trends , Medicare/economics , Medicare/trends , Quality of Health Care/economics , Quality of Health Care/trends , Research Report/trends , Aged , Coronary Artery Bypass/trends , Health Insurance Exchanges/economics , Health Insurance Exchanges/trends , Healthcare Financing , Humans , United States
13.
J Invasive Cardiol ; 26(12): E167-9, 2014 Dec.
Article in English | MEDLINE | ID: mdl-25481000

ABSTRACT

In the context of the rising health-care costs in the United States and the fact that approximately 1 million percutaneous coronary intervention (PCI) procedures are performed in the United States annually with a cost approaching $10 billion, reducing the cost associated with this frequently performed effective procedure has become paramount. Government and insurance-based methods have focused upon appropriate utilization and, in some cases, payment has been denied for procedures deemed inappropriate. While curtailing procedures may sometimes be reasonable, this approach is fraught with trouble, as individualized patient care does not fit neatly into population-based concepts of appropriateness. Therefore, alternative means to minimize expenditures should be entertained. Chief among these is the potential to reduce costs associated with PCI from prolonged inpatient stays for a procedure that, thankfully, has become significantly safer as it has maintained its efficacy. In this position paper, we discuss the theme of same-day discharge versus overnight stay after PCI as a cost-saving strategy, and pinpoint some criteria that can help to guide such a decision while preserving maximal patient safety and both patient and physician satisfaction.


Subject(s)
Ambulatory Care/economics , Angioplasty, Balloon, Coronary/economics , Coronary Artery Disease/economics , Coronary Artery Disease/therapy , Cost Savings/economics , Humans , United States
16.
Trials ; 15: 140, 2014 Apr 23.
Article in English | MEDLINE | ID: mdl-24758510

ABSTRACT

BACKGROUND: The management of patients with angiographically intermediate coronary lesions is a major clinical issue. Fractional flow reserve provides validated functional insights while optical coherence tomography provides high resolution anatomic imaging. Both techniques may be applied to guide management in case of angiographically intermediate coronary lesions. Moreover, these techniques may be used to optimize the result of percutaneous coronary intervention. We aim to compare the clinical and economic impact of fractional flow reserve versus optical coherence tomography guidance in patients with angiographically intermediate coronary lesions. METHODS/DESIGN: Patients with at least one angiographically intermediate coronary lesion will be randomized (ratio 1:1) to fractional flow reserve or optical coherence tomography guidance. In the fractional flow reserve arm, percutaneous coronary intervention will be performed if fractional flow reserve value is ≤0.80, and will be conducted with the aim of achieving a post-percutaneous coronary intervention fractional flow reserve target value of ≥0.90. In the optical coherence tomography arm, percutaneous coronary intervention will be performed if percentage of area stenosis (AS%) is ≥75% or 50 to 75% with minimal lumen area <2.5 mm2, or if a major plaque ulceration is detected. In case of percutaneous coronary intervention, optical coherence tomography will guide the procedure in order to minimize under-expansion, malapposition, and edge dissections.Cost load and clinical outcome will be prospectively assessed at one and thirteen months. The assessed clinical outcome measures will be: major cardiovascular events and occurrence of significant angina defined as a Seattle Angina Questionnaire score <90 in the angina frequency scale. DISCUSSION: The FORZA trial will provide useful guidance for the management of patients with coronary artery disease by prospectively assessing the use of two techniques representing the gold standard for functional and anatomical definition of coronary plaques. TRIAL REGISTRATION: Clinicaltrials.gov NCT01824030.


Subject(s)
Angioplasty, Balloon, Coronary , Coronary Angiography , Coronary Stenosis/therapy , Coronary Vessels , Fractional Flow Reserve, Myocardial , Research Design , Tomography, Optical Coherence , Angioplasty, Balloon, Coronary/adverse effects , Angioplasty, Balloon, Coronary/economics , Clinical Protocols , Coronary Angiography/economics , Coronary Stenosis/diagnostic imaging , Coronary Stenosis/economics , Coronary Stenosis/pathology , Coronary Stenosis/physiopathology , Coronary Vessels/diagnostic imaging , Coronary Vessels/pathology , Coronary Vessels/physiopathology , Cost-Benefit Analysis , Hospital Costs , Humans , Predictive Value of Tests , Prospective Studies , Rome , Severity of Illness Index , Surveys and Questionnaires , Tomography, Optical Coherence/economics , Treatment Outcome
17.
Curr Cardiol Rep ; 16(4): 470, 2014 Apr.
Article in English | MEDLINE | ID: mdl-24585111

ABSTRACT

Same-day percutaneous coronary intervention (PCI) is a reality with modern interventional equipment and pharmaceutical agents. Elective PCI is rarely an inpatient procedure and is now predominantly considered an outpatient procedure. Approaches to safely manage elective patients through same-day PCI have been well described in the literature and demonstrate no safety signal compared with overnight monitoring in the elective patient. With the costs of elective PCI being time dependent in comparison to fixed reimbursement of outpatient care, the efficiencies to bed utilization offered by same-day PCI make this attractive from an efficiency view point. Patient satisfaction improves with same-day discharge. The potential for cost-efficient care can only be maximized if health care providers view this shift to outpatient PCI care as an impetus to improve the whole care process rather than an administrative change with no effect on actual patient care. Same-day PCI is effective and can be integrated into modern health care.


Subject(s)
Ambulatory Surgical Procedures/trends , Angioplasty, Balloon, Coronary/trends , Coronary Disease/therapy , Elective Surgical Procedures/trends , Patient Discharge , Percutaneous Coronary Intervention , Ambulatory Care , Angioplasty, Balloon, Coronary/economics , Coronary Disease/economics , Coronary Disease/epidemiology , Cost-Benefit Analysis , Elective Surgical Procedures/economics , Female , Follow-Up Studies , Health Care Costs , Humans , Male , Patient Discharge/trends , Patient Satisfaction , Patient Selection , Percutaneous Coronary Intervention/economics , Percutaneous Coronary Intervention/trends , Time Factors , Treatment Outcome
18.
Curr Cardiol Rep ; 16(4): 469, 2014 Apr.
Article in English | MEDLINE | ID: mdl-24604695

ABSTRACT

Research and development in the field of coronary stent design is a fast-evolving and fascinating journey. A device that was once introduced to salvage acute closure associated with balloon angioplasty is now the standard of care for many patients with coronary artery disease. Newer generation stents are the product of remarkable progress in technology and innovation, driven by the need to make the stents easier to deliver and to improve their safety and efficacy. As such, the design of these stents has become quite sophisticated and complex. The number of available stents has increased giving patients and physicians more choices on one hand, but also created confusion in selecting the optimal stent for a given patient. Although a 'one size fits all' approach may not be reasonable, several randomized trials have attested to the efficacy and safety of newer generation durable polymer drug eluting stents. This article discusses the evidence base to support various stent choices in contemporary practice.


Subject(s)
Acute Coronary Syndrome/surgery , Angioplasty, Balloon, Coronary/trends , Cardiovascular Agents/administration & dosage , Diabetic Angiopathies/surgery , Myocardial Ischemia/surgery , Stents , Angioplasty, Balloon, Coronary/economics , Angioplasty, Balloon, Coronary/methods , Cost-Benefit Analysis , Evidence-Based Medicine , Female , Humans , Male , Patient Selection , Practice Guidelines as Topic , Stents/economics , Stents/trends , Treatment Outcome
19.
Ann Thorac Surg ; 97(5): 1610-5; discussion 1615-6, 2014 May.
Article in English | MEDLINE | ID: mdl-24636706

ABSTRACT

BACKGROUND: Hybrid coronary revascularization (HCR) combines a minimally invasive, left internal mammary artery-left anterior descending coronary artery (LAD) bypass with percutaneous intervention of non-LAD vessels for patients with multivessel coronary disease. The financial implications of HCR have not been compared with off-pump coronary artery bypass (OPCAB) through sternotomy. METHODS: The contribution margin is a fiduciary calculation (best hospital payment estimate--total variable costs) used by hospitals to determine fiscal viability of services. From 2010 to 2011, 26 Medicare patients underwent HCR at a single United States institution and were compared with 28 randomly selected, contemporaneous Medicare patients undergoing multivessel OPCAB. All HCR patients underwent a robotic-assisted, sternal-sparing, off-pump, left internal mammary artery-LAD anastomosis plus percutaneous intervention to non-LAD vessels. A linear regression model was used to compare fiscal and utilization outcomes of HCR to OPCAB adjusted for hospital length of stay and The Society of Thoracic Surgeons Predicted Risk of Mortality score. RESULTS: On regression analysis controlling for overall length of stay and Predicted Risk of Mortality score, the contribution margin (+$8,771, p<0.0001) was greater for HCR than for OPCAB. Despite higher total cost for HCR compared with OPCAB (+$7,026, p=0.001), the total variable cost (+$2,281, p=0.07) was not significantly different. Best payment estimates (+11,031, p<0.0001) and Medicare reimbursements (+$8,992, p=0.002) were higher for HCR than for OPCAB, and there was a reduction in blood transfusion (-1.5 units, p<0.0001), ventilator time (-10 hours, p=0.001), and postoperative length of stay (-1.2 days, p=0.002) for the HCR group. CONCLUSIONS: Compared with OPCAB, HCR results in a greater contribution margin for hospitals. This may result from higher reimbursement as well as improved resource utilization postoperatively, which may offset more expensive procedural costs associated with HCR.


Subject(s)
Angioplasty, Balloon, Coronary/economics , Hospital Costs , Insurance, Health, Reimbursement/economics , Internal Mammary-Coronary Artery Anastomosis/economics , Medicare/economics , Aged , Angioplasty, Balloon, Coronary/methods , Cohort Studies , Coronary Angiography/methods , Coronary Artery Bypass, Off-Pump/economics , Coronary Artery Bypass, Off-Pump/methods , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/economics , Coronary Artery Disease/surgery , Cost-Benefit Analysis , Databases, Factual , Female , Humans , Internal Mammary-Coronary Artery Anastomosis/methods , Length of Stay/economics , Male , Myocardial Revascularization/economics , Myocardial Revascularization/methods , Severity of Illness Index , United States
20.
G Ital Cardiol (Rome) ; 14(10): 681-9, 2013 Oct.
Article in Italian | MEDLINE | ID: mdl-24121894

ABSTRACT

Drug-coated balloons are a new tool for the treatment of patients with coronary artery disease. The main feature of this technology is a rapid and homogeneous transfer of an antiproliferative drug (paclitaxel) to the vessel wall just at the time of balloon inflation, when neointimal proliferation, in response to angioplasty, is the highest. Moreover, drug-coated balloons share adjunctive advantages over stents: the absence of permanent scaffold and polymer, the respect of the original coronary anatomy, and limited inflammatory stimuli, thereby allowing for short-term dual antiplatelet therapy. At present, a variety of devices are available in the market, with limited scientific data for the vast majority of them. Thus, the Italian Society of Interventional Cardiology (SICI-GISE) decided to coordinate the efforts of a group of renowned experts in this field, in order to produce a position paper on the correct use of drug-coated balloons in all settings of coronary artery disease, giving a class of indication to each one, based on clinical evidence. This position paper represents a quick reference for operators, investigators and manufacturers to promote the understanding and the correct use of the drug-coated balloon technology in everyday clinical practice.


Subject(s)
Angioplasty, Balloon, Coronary/instrumentation , Coronary Disease/therapy , Coronary Restenosis/prevention & control , Paclitaxel/administration & dosage , Angioplasty, Balloon, Coronary/economics , Clinical Trials as Topic , Coronary Artery Disease/drug therapy , Coronary Artery Disease/therapy , Coronary Disease/drug therapy , Cost-Benefit Analysis , Drug-Eluting Stents , Equipment Design , Evidence-Based Medicine , Humans , Multicenter Studies as Topic , Myocardial Infarction/drug therapy , Myocardial Infarction/therapy , Neointima/pathology , Paclitaxel/economics , Paclitaxel/therapeutic use , Platelet Aggregation Inhibitors/pharmacology , Platelet Aggregation Inhibitors/therapeutic use , Registries
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