CACS, CCTA and mCAD-LT score in the pre-transplant assessment of coronary artery disease and the prediction of post-transplant cardiovascular events.

BACKGROUND: The optimal cardiovascular assessment of liver transplant (LT) candidates is unclear. We aimed to evaluate the performance of CT-based coronary tests (coronary artery calcium score [CACS] and coronary CT angiography [CCTA]) and a modification of the CAD-LT score (mCAD-LT, excluding family history of CAD) to diagnose significant coronary artery disease (CAD) before LT and predict the incidence of post-LT cardiovascular events (CVE). METHODS: We retrospectively analysed a single-centre cohort of LT candidates who underwent non-invasive tests; invasive coronary angiography (ICA) was performed depending on the results of non-invasive tests. mCAD-LT was calculated in all patients. RESULTS: Six-hundred-and-thirty-four LT candidates were assessed and 351 of them underwent LT. CACS, CCTA and ICA were performed in 245, 123 and 120 LT candidates, respectively. Significant CAD was found in 30% of patients undergoing ICA. The AUROCs of mCAD-LT (.722) and CCTA (.654) were significantly higher than that of CACS (.502) to predict the presence of significant CAD. Specificity of the tests ranged between 31% for CCTA and 53% for CACS. Among patients who underwent LT, CACS ≥ 400 and mCAD-LT were independently associated with the incidence of CVE; in patients who underwent CCTA before LT, significant CAD at CCTA also predicted post-LT CVE. CONCLUSION: In this cohort, mCAD-LT score and CT-based tests detect the presence of significant CAD in LT candidates, although they tend to overestimate it. Both mCAD-LT score and CT-based tests classify LT recipients according to their risk of post-LT CVE and can be used to improve post-LT risk mitigation.

Instantaneous Wave-Free Ratio for the Assessment of Intermediate Left Main Coronary Artery Stenosis: Correlations With Fractional Flow Reserve/Intravascular Ultrasound and Prognostic Implications: The iLITRO-EPIC07 Study.

BACKGROUND: There is little information available on agreement between fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR) in left main coronary artery (LMCA) intermediate stenosis. Besides, several meta-analyses support the use of FFR to guide LMCA revascularization, but limited information is available on iFR in this setting. Our aims were to establish the concordance between FFR and iFR in intermediate LMCA lesions, to evaluate with intravascular ultrasound (IVUS) in cases of FFR/iFR discordance, and to prospectively validate the safety of deferring revascularization based on a hybrid decision-making strategy combining iFR and IVUS. METHODS: Prospective, observational, multicenter registry with 300 consecutive patients with intermediate LMCA stenosis who underwent FFR and iFR and, in case of discordance, IVUS and minimal lumen area measurements. Primary clinical end point was a composite of cardiovascular death, LMCA lesion-related nonfatal myocardial infarction, or unplanned LMCA revascularization. RESULTS: FFR and iFR had an agreement of 80% (both positive in 67 and both negative in 167 patients); in case of disagreement (31 FFR+/iFR- and 29 FFR-/iFR+) minimal lumen area was ≥6 mm2 in 8.7% of patients with FFR+ and 14.6% with iFR+. Among the 300 patients, 105 (35%) underwent revascularization and 181 (60%) were deferred according to iFR and IVUS. At a median follow-up of 20 months, major adverse cardiac events incidence was 8.3% in the defer group and 13.3% in the revascularization group (hazard ratio, 0.71 [95% CI 0.30-1.72]; P=0.45). CONCLUSIONS: In patients with intermediate LMCA stenosis, a physiology-guided treatment decision is feasible either with FFR or iFR with moderate concordance between both indices. In case of disagreement, the use of IVUS may be useful to indicate revascularization. Deferral of revascularization based on iFR appears to be safe in terms of major adverse cardiac events. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT03767621.

Sex Differences in Instantaneous Wave-Free Ratio or Fractional Flow Reserve-Guided Revascularization Strategy.

OBJECTIVES: This study sought to evaluate sex differences in procedural characteristics and clinical outcomes of instantaneous wave-free ratio (iFR)- and fractional flow reserve (FFR)-guided revascularization strategies. BACKGROUND: An iFR-guided strategy has shown a lower revascularization rate than an FFR-guided strategy, without differences in clinical outcomes. METHODS: This is a post hoc analysis of the DEFINE-FLAIR (Functional Lesion Assessment of Intermediate stenosis to guide Revascularization) study, in which 601 women and 1,891 men were randomized to iFR- or FFR-guided strategy. The primary endpoint was 1-year major adverse cardiac events (MACE), a composite of all-cause death, nonfatal myocardial infarction, or unplanned revascularization. RESULTS: Among the entire population, women had a lower number of functionally significant lesions per patient (0.31 ± 0.51 vs. 0.43 ± 0.59; p < 0.001) and less frequently underwent revascularization than men (42.1% vs. 53.1%; p < 0.001). There was no difference in mean iFR value according to sex (0.91 ± 0.09 vs. 0.91 ± 0.10; p = 0.442). However, the mean FFR value was lower in men than in women (0.83 ± 0.09 vs. 0.85 ± 0.10; p = 0.001). In men, an FFR-guided strategy was associated with a higher rate of revascularization than an iFR-guided strategy (57.1% vs. 49.3%; p = 0.001), but this difference was not observed in women (41.4% vs. 42.6%; p = 0.757). There was no difference in MACE rates between iFR- and FFR-guided strategies in both women (5.4% vs. 5.6%, adjusted hazard ratio: 1.10; 95% confidence interval: 0.50 to 2.43; p = 0.805) and men (6.6% vs. 7.0%, adjusted hazard ratio: 0.98; 95% confidence interval: 0.66 to 1.46; p = 0.919). CONCLUSIONS: An FFR-guided strategy was associated with a higher rate of revascularization than iFR-guided strategy in men, but not in women. However, iFR- and FFR-guided strategies showed comparable clinical outcomes, regardless of sex. (Functional Lesion Assessment of Intermediate Stenosis to guide Revascularization [DEFINE-FLAIR]; NCT02053038).

Clinical Events After Deferral of LAD Revascularization Following Physiological Coronary Assessment.

BACKGROUND: Physicians are not always comfortable deferring treatment of a stenosis in the left anterior descending (LAD) artery because of the perception that there is a high risk of major adverse cardiac events (MACE). The authors describe, using the DEFINE-FLAIR (Functional Lesion Assessment of Intermediate Stenosis to Guide Revascularisation) trial, MACE rates when LAD lesions are deferred, guided by physiological assessment using fractional flow reserve (FFR) or the instantaneous wave-free ratio (iFR). OBJECTIVES: The purpose of this study was to establish the safety of deferring treatment in the LAD using FFR or iFR within the DEFINE-FLAIR trial. METHODS: MACE rates at 1 year were compared between groups (iFR and FFR) in patients whose physiological assessment led to LAD lesions being deferred. MACE was defined as a composite of cardiovascular death, myocardial infarction (MI), and unplanned revascularization at 1 year. Patients, and staff performing follow-up, were blinded to whether the decision was made with FFR or iFR. Outcomes were adjusted for age and sex. RESULTS: A total of 872 patients had lesions deferred in the LAD (421 guided by FFR, 451 guided by iFR). The event rate with iFR was significantly lower than with FFR (2.44% vs. 5.26%; adjusted HR: 0.46; 95% confidence interval [CI]: 0.22 to 0.95; p = 0.04). This was driven by significantly lower unplanned revascularization with iFR and numerically lower MI (unplanned revascularization: 2.22% iFR vs. 4.99% FFR; adjusted HR: 0.44; 95% CI: 0.21 to 0.93; p = 0.03; MI: 0.44% iFR vs. 2.14% FFR; adjusted HR: 0.23; 95% CI: 0.05 to 1.07; p = 0.06). CONCLUSIONS: iFR-guided deferral appears to be safe for patients with LAD lesions. Patients in whom iFR-guided deferral was performed had statistically significantly lower event rates than those with FFR-guided deferral.

The influence of Elixhauser comorbidity index on percutaneous coronary intervention outcomes.

BACKGROUND: Clinical outcomes with respect to the evolution of comorbidity burden in national cohorts of patients undergoing PCI have not been reported. OBJECTIVES: We sought to explore the association between comorbidity burden and periprocedural outcomes in patients treated with PCI in the National Inpatient Sample. METHODS: 6,601,526 PCI procedures were identified between 2004 and 2014 and comorbidities were defined by the Elixhauser classification system (ECS) consisting of 30 comorbidity measures. Endpoints included in-hospital mortality, periprocedural complications, length of stay and cost. Patients were classified based on their ECS in five categories (ECS I < 0, ECS II = 0, ECS III = 1-5, ECS IV = 6-13, and ECS V ≥ 14). RESULTS: Patients with a score over 13 had a fivefold increase in the odds of mortality (OR: 5.13, 95% CI: 4.76-5.54), major bleeding (OR: 11.46, 95% CI: 10.66-12.33) and doubled the hospitalization costs ($31,452 vs $17.566). CONCLUSIONS: Our study of over six million PCI procedures demonstrates that patients with the greatest comorbid burden (as defined by an ECS of >13) have a fivefold increase risk of in-hospital mortality, a fourfold increase in in-hospital periprocedural complications and an 11-fold increase in major bleeding events once differences in baseline patient characteristics are adjusted for. In addition, ECS significantly impacts the length of stay and doubles the healthcare costs. Comorbid burden is an important predictor of poor outcomes after PCI and should be considered as part of the decision-making processes in patients undergoing PCI.

A serial 3- and 9-year optical coherence tomography assessment of vascular healing response to sirolimus- and paclitaxel-eluting stents.

Early-generation drug-eluting stents (DES) have been demonstrated to delay vascular healing. Limited optical coherence tomography (OCT) data on the very long-term neointimal response after DES implantation are available. The aim of this study was a serial OCT assessment of neointimal thickness, stent strut coverage, malapposition, and protrusion as markers of neointimal response at 3 and 9 years after implantation of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES). In this single-centre, longitudinal study consecutive patients undergoing elective PCI with SES or PES were included. OCT analysis was performed after 3 and 9 years by the independent core laboratory. A total of 22 subjects (8 SES and 14 PES) underwent an OCT assessment at 3 and 9 years post index procedure. The lumen, neointimal and malapposition area and the neointimal thickness (SES ∆50 µm, p = 0.195, PES ∆10 µm, p = 0.951) did not change significantly over the 6 year follow-up. No differences in the incidence of uncovered, malapposed or protruding struts were found in each type of stent. At 3 and 9 years after PCI, implantation of early-generation SES and PES may be associated with similar neointimal thickness, strut coverage, malapposition and protrusion, as assessed by serial OCT examination among patients with uneventful follow-up at 3 years post procedure. The small size of the study warrants judicious interpretation of our results and confirmation in larger multimodality imaging studies, including patients treated with contemporary stent platforms.

Cost-effectiveness of everolimus-eluting versus bare-metal stents in ST-segment elevation myocardial infarction: An analysis from the EXAMINATION randomized controlled trial.

BACKGROUND: Use of everolimus-eluting stents (EES) has proven to be clinically effective and safe in patients with ST-segment elevation myocardial infarction but it remains unclear whether it is cost-effective compared to bare-metal stents (BMS) in the long-term. We sought to assess the cost-effectiveness of EES versus BMS based on the 5-year results of the EXAMINATION trial, from a Spanish health service perspective. METHODS: Decision analysis of the use of EES versus BMS was based on the patient-level clinical outcome data of the EXAMINATION trial. The analysis adopted a lifelong time horizon, assuming that long-term survival was independent of the initial treatment strategy after the end of follow-up. Life-expectancy, health-state utility scores and unit costs were extracted from published literature and publicly available sources. Non-parametric bootstrapping was combined with probabilistic sensitivity analysis to co-assess the impact of patient-level variation and parameter uncertainty. The main outcomes were total costs and quality-adjusted life-years. The incremental cost-effectiveness ratio was expressed as cost per quality-adjusted life-years gained. Costs and effects were discounted at 3%. RESULTS: The model predicted an average survival time in patients receiving EES and BMS of 10.52 and 10.38 undiscounted years, respectively. Over the life-long time horizon, the EES strategy was €430 more costly than BMS (€8,305 vs. €7,874), but went along with incremental gains of 0.10 quality-adjusted life-years. This resulted in an average incremental cost-effectiveness ratio over all simulations of €3,948 per quality-adjusted life-years gained and was below a willingness-to-pay threshold of €25,000 per quality-adjusted life-years gained in 86.9% of simulation runs. CONCLUSIONS: Despite higher total costs relative to BMS, EES appeared to be a cost-effective therapy for ST-segment elevation myocardial infarction patients due to their incremental effectiveness. Predicted incremental cost-effectiveness ratios were below generally acceptable threshold values.

Long-Term Coronary Functional Assessment of the Infarct-Related Artery Treated With Everolimus-Eluting Bioresorbable Scaffolds or Everolimus-Eluting Metallic Stents: Insights of the TROFI II Trial.

OBJECTIVES: The study sought to compare the vasomotor and microcirculatory function of the infarct-related artery (IRA) between bioresorbable vascular scaffolds (BVS) and everolimus-eluting stents (EES) at 3 years. BACKGROUND: The ABSORB STEMI TROFI II study showed similar outcomes between BVS and EES in the context of ST-segment elevation myocardial infarction at 3 years. METHODS: Sixty-three consecutive event-free patients of the randomized TROFI II study were screened to undergo coronary angiography with vasomotor, microcirculatory, and optical coherence tomography (OCT) examination at 3 years. Vasomotion was defined as >4% change in mean lumen diameter to acetylcholine (ACH) and nitroglycerin as assessed by quantitative angiography. Microcirculatory examination was performed with pressure or thermodilution techniques. RESULTS: A total of 38 patients (20 BVS and 18 EES) were included. At 3 years, ≥60% of patients exhibited paradoxical vasoconstriction to ACH in the periscaffold or stent segments. Vasoconstriction to ACH and vasodilatation to nitroglycerin were more often observed in the scaffold or stent segment with BVS than with EES (77.8% vs. 25.0%; p = 0.008 and 61.1% vs. 18.8%; p = 0.018). The IRA-depending microcirculation showed similar index of resistance (23.8 vs. 22.4; p = 0.781), coronary flow reserve (2.4 vs. 1.9; p = 0.523), fractional flow reserve (0.91 vs. 0.93; p = 0.317), and absolute flow (135.5 ml/min vs. 147.3 ml/min; p = 0.791). OCT showed remaining strut footprints and larger number of intraluminal scaffold dismantling (26.3% vs. 0%; p = 0.049) in the BVS group. CONCLUSIONS: Both endothelium-dependent and -independent vasomotion of the IRA were more evident with BVS, as compared with EES, at 3 years. Functional microcirculatory parameters were mostly adequate and similar between BVS and EES. Clinical implications of these findings warrant further investigations.

First serial optical coherence tomography assessment at baseline, 12 and 24 months in STEMI patients treated with the second-generation Absorb bioresorbable vascular scaffold.

AIMS: The aim of the study was to assess the vascular healing response after Absorb bioresorbable vascular scaffold (BVS) implantation in patients with ST-segment elevation myocardial infarction (STEMI) utilising truly serial optical coherence tomography (OCT) examination at baseline, 12 and 24 months. METHODS AND RESULTS: This was a single-centre, prospective, longitudinal study with baseline, 12- and 24-month OCT evaluation of 18 STEMI patients treated with 22 Absorb BVS. The healing pattern was evaluated based upon lumen area, neointimal hyperplasia, strut coverage and apposition. The lumen area decreased at 12 months compared to baseline (8.52±1.69 mm² vs. 7.0±1.70 mm², p<0.01), but it did not change from that point onwards up to 24 months (7.0±1.70 mm² vs. 6.94±1.65 mm², p=0.92). At 12 months after the index procedure, the mean neointimal thickness was 217±69 µm and further neointimal hyperplasia was observed between 12 and 24 months though less pronounced (Δ62±44 µm, p<0.0001). Full circumferential coverage of the vessel wall by neointima was observed in 92% of frames at 24 months. The low number of malapposed struts at the index procedure (<5%) further decreased over the observation period and was found in only one patient at 12 and 24 months. The ratio of uncovered struts was low at both 12 and 24 months. CONCLUSIONS: This serial OCT analysis of the second-generation everolimus-eluting BVS in a STEMI population confirmed a favourable healing pattern as expressed by moderate neointimal growth, preserved lumen area and no late acquired malapposition.

Cost-effectiveness of percutaneous coronary intervention with cobalt-chromium everolimus eluting stents versus bare metal stents: Results from a patient level meta-analysis of randomized trials.

BACKGROUND: Second-generation drug eluting stents (DES) may reduce costs and improve clinical outcomes compared to first-generation DES with improved cost-effectiveness when compared to bare metal stents (BMS). We aimed to conduct an economic evaluation of a cobalt-chromium everolimus eluting stent (Co-Cr EES) compared with BMS in percutaneous coronary intervention (PCI). OBJECTIVE: To conduct a cost-effectiveness analysis (CEA) of a cobalt-chromium everolimus eluting stent (Co-Cr EES) versus BMS in PCI. METHODS: A Markov state transition model with a 2-year time horizon was applied from a US Medicare setting with patients undergoing PCI with Co-Cr EES or BMS. Baseline characteristics, treatment effects, and safety measures were taken from a patient level meta-analysis of 5 RCTs (n = 4,896). The base-case analysis evaluated stent-related outcomes; a secondary analysis considered the broader set of outcomes reported in the meta-analysis. RESULTS: The base-case and secondary analyses reported an additional 0.018 and 0.013 quality-adjusted life years (QALYs) and cost savings of $236 and $288, respectively with Co-Cr EES versus BMS. Results were robust to sensitivity analyses and were most sensitive to the price of clopidogrel. In the probabilistic sensitivity analysis, Co-Cr EES was associated with a greater than 99% chance of being cost saving or cost effective (at a cost per QALY threshold of $50,000) versus BMS. CONCLUSIONS: Using data from a recent patient level meta-analysis and contemporary cost data, this analysis found that PCI with Co-Cr EES is more effective and less costly than PCI with BMS. © 2016 The Authors. Catheterization and Cardiovascular Interventions Published by Wiley Periodicals, Inc.

Serial optical coherence tomography assessment of malapposed struts after everolimus-eluting stent implantation. A subanalysis from the HEAL-EES study.

BACKGROUND: Incomplete stent apposition (ISA) is related to stent thrombosis, which is a serious adverse event. We aim to assess the time-course of ISA after 2nd generation everolimus-eluting stent (EES) implantation. METHODS: In HEAL-EES study, we enrolled 36 patients who underwent percutaneous coronary intervention (PCI) with EES. OCT imaging was performed at baseline and follow-up. Patients were randomized 1:1:1 into 3 groups according to the time in which follow-up was performed: group A (6-month), group B (9-month), and group C (12-month). In this subanalysis, patients who had ISA segments at baseline and/or follow-up OCT were analyzed. RESULT: At baseline, among 41 lesions in 36 patients, 20 lesions in 18 patients had ISA segments and were analyzed. At baseline, there were 3.0% ISA struts in group A (n=8), 2.8% in group B (n=4), and 4.5% in group C (n=8). At follow-up, ISA struts were present in 0.09%, 0.16% and 0.64%; respectively in groups A, B, and C. At follow-up, there was a significant decrease in the frequency of ISA: group A 3.0% vs. 0.09% (p<0.001), group B 2.8% vs. 0.16% (p<0.001), and group C 4.5% vs. 0.64% (p<0.001). In group A, there was one late acquired ISA at follow-up. CONCLUSIONS: In patients undergoing 2nd generation EES implantation, area of acute ISA assessed by OCT, was almost resolved at 6-month follow-up.

Beneficio de la implementación de un sistema de atención en red sobre las mujeres con infarto agudo de miocardio con elevación del segmento ST / Benefit of the implementation of a ST-segment elevation myocardial infarction network on women

Objetivo: El sistema de atención en red por infarto con elevación del segmento ST «Codi Infart¼ se implementó en Cataluña (España) en junio de 2009. El objetivo del estudio fue evaluar el beneficio de la instauración del Codi Infart para las mujeres atendidas en nuestra institución. Método: Las mujeres referidas para angioplastia primaria se dividieron en 2 grupos de acuerdo con el Codi Infart: grupo no-Codi Infart (enero de 2003 a mayo de 2009) y grupo Codi Infart (junio de 2009 a diciembre de 2012); y se compararon lugar de procedencia, periodos, tratamientos recibidos y tasa de eventos cardiovasculares mayores definida como muerte por todas las causas, reinfarto o accidente cerebrovascular durante el ingreso, a 30 y 180 días. Resultados: De una población total de 2,426 pacientes, 501 (20.7%) eran mujeres. De ellas, 186 mujeres (2,09 casos/mes) pertenecían al grupo no-Codi Infart y 315 mujeres (10,16 casos/mes) al grupo Codi Infart. El porcentaje de mujeres atendidas aumentó desde la introducción del Codi Infart(22.2% vs. 18.5%, p = 0.028). Además, inicialmente el grupo Codi Infart presentó mayor porcentaje de mujeres atendidas fuera de nuestra institución (84.1% vs. 16.7%, p < 0.001), y menores tiempos totales de isquemia (220 [155-380] vs. 272 [196-456], p = 0.003), pero no se detectaron diferencias en eventos cardiovasculares mayores a 180 días (14.2% vs. 15.6%, p = 0.692). Conclusiones: La instauración del Codi Infart permitió aumentar de manera notable la tasa y el porcentaje de mujeres con infarto de miocardio con elevación del segmento ST tratadas mediante angioplastia primaria y reducir los tiempos totales de isquemia.

Objective: The ST-segment elevation myocardial infarction network "Codi Infart" was implemented in Catalonia (Spain) in June 2009. The objective of this study was to evaluate the impact of the implementation of the Codi Infart on women. Method: Women referred for primary percutaneous coronary intervention, were divided into two groups according to Codi Infart: Non-Codi Infart group (January 2003 to May 2009) and Codi Infart group (June 2009 to December 2012). Place of first medical contact, time intervals in diagnosis and treatment, treatments received and rate of major cardiovascular adverse events defined as all-cause death, reinfarction or stroke in-hospital, at 30 and 180 days were compared. Results: From a total population of 2,426 patients, 501 (20.7%) were women. One-hundred eighty-six women (2.09 cases/month) belonged to Non-Codi Infart group and 315 women (10.16 cases/month) to Codi Infart group. The percentage of women attended increased since the introduction of CI (22.2% vs. 18.5%, P = .028). In addition, the Codi Infart group had a higher percentage of women initially attended outside our institution (84.1% vs. 16.7%, P < .001), and lower total ischemia time (220 [155-380] vs. 272 [196-456], P = .003). However, no differences in 180-day major cardiovascular adverse events were detected (14.2% vs. 15.6%, P = .692). Conclusions: The implementation of the major cardiovascular adverse events allowed to increase the rate and the percentage of women with ST-segment elevation myocardial infarction treated with primary percutaneous coronary intervention and reducing total ischemic time.

[Benefit of the implementation of a ST-segment elevation myocardial infarction network on women]. / Beneficio de la implementación de un sistema de atención en red sobre las mujeres con infarto agudo de miocardio con elevación del segmento ST.

OBJECTIVE: The ST-segment elevation myocardial infarction network "Codi Infart" was implemented in Catalonia (Spain) in June 2009. The objective of this study was to evaluate the impact of the implementation of the Codi Infart on women. METHOD: Women referred for primary percutaneous coronary intervention, were divided into two groups according to Codi Infart: Non-Codi Infart group (January 2003 to May 2009) and Codi Infart group (June 2009 to December 2012). Place of first medical contact, time intervals in diagnosis and treatment, treatments received and rate of major cardiovascular adverse events defined as all-cause death, reinfarction or stroke in-hospital, at 30 and 180 days were compared. RESULTS: From a total population of 2,426 patients, 501 (20.7%) were women. One-hundred eighty-six women (2.09 cases/month) belonged to Non-Codi Infart group and 315 women (10.16 cases/month) to Codi Infart group. The percentage of women attended increased since the introduction of CI (22.2% vs. 18.5%, P=.028). In addition, the Codi Infart group had a higher percentage of women initially attended outside our institution (84.1% vs. 16.7%, P<.001), and lower total ischemia time (220 [155-380] vs. 272 [196-456], P=.003). However, no differences in 180-day major cardiovascular adverse events were detected (14.2% vs. 15.6%, P=.692). CONCLUSIONS: The implementation of the major cardiovascular adverse events allowed to increase the rate and the percentage of women with ST-segment elevation myocardial infarction treated with primary percutaneous coronary intervention and reducing total ischemic time.

Need and disparities in primary care management of patients with diabetes.

BACKGROUND: An aging population means that chronic illnesses, such as diabetes, are becoming more prevalent and demands for care are rising. Members of primary care teams should organize and coordinate patient care with a view to improving quality of care and impartial adherence to evidence-based practices for all patients. The aims of the present study were: to ascertain the prevalence of diabetes in an Italian population, stratified by age, gender and citizenship; and to identify the rate of compliance with recommended guidelines for monitoring diabetes, to see whether disparities exist in the quality of diabetes patient management. METHODS: A population-based analysis was performed on a dataset obtained by processing public health administration databases. The presence of diabetes and compliance with standards of care were estimated using appropriate algorithms. A multilevel logistic regression analysis was applied to assess factors affecting compliance with standards of care. RESULTS: 1,948,622 Italians aged 16+ were included in the study. In this population, 105,987 subjects were identified as having diabetes on January 1st, 2009. The prevalence of diabetes was 5.43% (95% CI 5.33-5.54) overall, 5.87% (95% CI 5.82-5.92) among males, and 5.05% (95% CI 5.00-5.09) among females. HbA1c levels had been tested in 60.50% of our diabetic subjects, LDL cholesterol levels in 57.50%, and creatinine levels in 63.27%, but only 44.19% of the diabetic individuals had undergone a comprehensive assessment during one year of care. Statistical differences in diabetes care management emerged relating to gender, age, diagnostic latency period, comorbidity and citizenship. CONCLUSIONS: Process management indicators need to be used not only for the overall assessment of health care processes, but also to monitor disparities in the provision of health care.

Assessment of plaque composition by intravascular ultrasound and near-infrared spectroscopy: from PROSPECT I to PROSPECT II.

Atherosclerosis is the main cause of coronary artery disease (CAD), which is today the leading cause of death worldwide and will continue to be the first in the world in 2030. Vulnerable coronary plaques are usually characterized by a high content of necrotic core, a thin inflamed fibrous cap (intense accumulation of macrophages) and scarce presence of smooth muscle cells. None of these characteristics can be estimated by coronary angiography, which on the contrary underestimates the magnitude of atherosclerotic burden, particularly in earlier stage disease when positive vascular remodeling may allow "normal" lumen caliber despite substantial vascular wall plaque. The recognition of the ubiquity of substantial but non-flow limiting lesions that may be at high risk for subsequent plaque rupture has resulted in a paradigm shift in thinking about the pathophysiology of CAD, with the focus no longer solely on the degree of arterial luminal narrowing. This growing need for more information about coronary atherosclerosis in order to identify patients and lesions at risk for complications during PCI and for future adverse cardiac events has been the primary impetus for the development of novel intracoronary imaging methods able to detect plaque composition, in particular presence of a necrotic core/lipid pool, such as intravascular ultrasound virtual histology and near-infrared spectroscopy. These imaging technologies and their clinical and clinical/research applications are discussed in detail.

Can Italian healthcare administrative databases be used to compare regions with respect to compliance with standards of care for chronic diseases?

BACKGROUND: Italy has a population of 60 million and a universal coverage single-payer healthcare system, which mandates collection of healthcare administrative data in a uniform fashion throughout the country. On the other hand, organization of the health system takes place at the regional level, and local initiatives generate natural experiments. This is happening in particular in primary care, due to the need to face the growing burden of chronic diseases. Health services research can compare and evaluate local initiatives on the basis of the common healthcare administrative data.However reliability of such data in this context needs to be assessed, especially when comparing different regions of the country. In this paper we investigated the validity of healthcare administrative databases to compute indicators of compliance with standards of care for diabetes, ischaemic heart disease (IHD) and heart failure (HF). METHODS: We compared indicators estimated from healthcare administrative data collected by Local Health Authorities in five Italian regions with corresponding estimates from clinical data collected by General Practitioners (GPs). Four indicators of diagnostic follow-up (two for diabetes, one for IHD and one for HF) and four indicators of appropriate therapy (two each for IHD and HF) were considered. RESULTS: Agreement between the two data sources was very good, except for indicators of laboratory diagnostic follow-up in one region and for the indicator of bioimaging diagnostic follow-up in all regions, where measurement with administrative data underestimated quality. CONCLUSION: According to evidence presented in this study, estimating compliance with standards of care for diabetes, ischaemic heart disease and heart failure from healthcare databases is likely to produce reliable results, even though completeness of data on diagnostic procedures should be assessed first. Performing studies comparing regions using such indicators as outcomes is a promising development with potential to improve quality governance in the Italian healthcare system.

Waiting time prioritisation for specialist services in Italy: the homogeneous waiting time groups approach.

The demand for referrals and diagnostic procedures in Italy has been rising constantly in recent years, making access to diagnostic services increasingly difficult with significant waiting times. A number of Health Authorities (known as Local Health Units) have responded by implementing formalised waiting-time prioritisation tools, giving rise to what are known as Homogeneous Waiting Groups (HWGs). The study describes the implementation of the HWG approach in Italy. This represents a promising tool for improving the prioritisation of patients waiting to see a specialist or to receive a diagnostic test. The study of the Italian HWG experience provides useful insights to improve the outpatient referral process for those countries where the demand prioritisation policies have focused more on inpatient care than outpatient specialist care and diagnostic services.

Systematic age-related differences in chronic disease management in a population-based cohort study: a new paradigm of primary care is required.

BACKGROUND: Our interest in chronic conditions is due to the fact that, worldwide, chronic diseases have overtaken infectious diseases as the leading cause of death and disability, so their management represents an important challenge for health systems. The aim of this study was to compare the performance of primary health care services in managing diabetes, congestive heart failure (CHF) and coronary heart disease (CHD), by age group. METHODS: This population-based retrospective cohort study was conducted in Italy, enrolling 1,948,622 residents ≥ 16 years old. A multilevel regression model was applied to analyze compliance to care processes with explanatory variables at both patient and district level, using age group as an independent variable, and adjusting for sex, citizenship, disease duration, and Charlson index on the first level, and for District Health Unit on the second level. RESULTS: The quality of chronic disease management showed an inverted U-shaped relationship with age. In particular, our findings indicate lower levels for young adults (16-44 year-olds), adults (45-64), and oldest old (+85) than for patients aged 65-74 in almost all quality indicators of CHD, CHF and diabetes management. Young adults (16-44 y), adults (45-64 y), the very old (75-84 y) and the oldest old (+85 y) patients with CHD, CHF and diabetes are less likely than 65-74 year-old patients to be monitored and treated using evidence-based therapies, with the exceptions of echocardiographic monitoring for CHF in young adult patients, and renal monitoring for CHF and diabetes in the very old. CONCLUSION: Our study shows that more effort is needed to ensure that primary health care systems are sensitive to chronic conditions in the young and in the very elderly.