Publications by authors named "Valentina Lorenzoni"

76 Publications

Duration of response after DEB-TACE compared to lipiodol-TACE in HCC-naïve patients: a propensity score matching analysis.

Eur Radiol 2021 Apr 19. Epub 2021 Apr 19.

Department of Interventional Radiology, Pisa University Hospital, Via Paradisa 2, 56126, Pisa, Italy.

Objectives: To retrospectively compare long-term outcomes of first-line drug-eluting particle (DEB)- transarterial chemoembolization (TACE) and lipiodol-TACE, in patients with unresectable hepatocellular (HCC).

Methods: We retrospectively reviewed our database to identify adult patients with treatment-naïve unresectable HCC, who underwent TACE from 2006 to 2013. Patients were excluded in the absence of complete medical records relative to first TACE, 1-month follow-up, and/or sufficient follow-up data. Periprocedural complications, duration of hospitalization, 1-month tumor response by mRECIST, time to tumor progression (TTP) and target tumor progression (TTTP), and overall survival (OS) were evaluated.

Results: Out of an initial series of 656 patients, 329 patients were excluded for unavailability of sufficient baseline and/or follow-up data. The remaining 327 patients underwent either lipiodol-TACE (n = 160) or DEB-TACE (n = 167). Patients treated with lipiodol-TACE had a significantly higher tumor burden. By propensity score, patients were matched according to baseline differences (BCLC stage, uninodular or multinodular HCC, and unilobar or bilobar HCC), resulting in 101 patients in each treatment group. Lipiodol-TACE was associated with a significantly higher incidence of adverse events (p = 0.03), and longer hospitalization (mean, 2.5 days vs 1.9 days; p = 0.03), while tumor response, TTP, and OS were comparable. In patients achieving 1-month complete response (CR) of target tumor, TTTP was significantly (p = 0.009) longer after DEB-TACE compared to lipiodol-TACE (median, 835 vs 353 days), resulting in a lower number of re-treatments during the entire follow-up (0.75 vs 1.6, p = 0.01).

Conclusion: Compared to lipiodol-TACE, DEB-TACE offers higher tolerability, reduced hospitalization, and more durable target tumor response after CR.

Key Points: • Compared to lipiodol-TACE, DEB-TACE is better tolerated and has reduced side effects, which translates into shorter hospitalization. • When complete radiological response according to the mRECIST is obtained 1 month after the procedure, DEB-TACE offers a more durable local tumor control compared to lipiodol-TACE. • In these patients, the longer duration of response after DEB-TACE translates into a lower number of re-interventions.
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http://dx.doi.org/10.1007/s00330-021-07905-xDOI Listing
April 2021

Prognostic Value of Reduced Heart Rate Reserve during Exercise in Hypertrophic Cardiomyopathy.

J Clin Med 2021 Mar 24;10(7). Epub 2021 Mar 24.

Institute of Management, Scuola Superiore Sant'Anna, 56127 Pisa, Italy.

Background: Sympathetic dysfunction can be evaluated by heart rate reserve (HRR) with exercise test.

Objectives: To determine the value of HRR in predicting outcome of patients with hypertrophic cardiomyopathy (HCM).

Methods: We enrolled 917 HCM patients (age = 49 ± 15 years, 516 men) assessed with exercise stress echocardiography (ESE) in 11 centres. ESE modality was semi-supine bicycle in 51 patients (6%), upright bicycle in 476 (52%), and treadmill in 390 (42%). During ESE, we assessed left ventricular outflow tract obstruction (LVOTO), stress-induced new regional wall motion abnormalities (RWMA), and HRR (peak/rest heart rate, HR). By selection, all patients completed the follow-up. Mortality was the predetermined outcome measure Results: During ESE, RWMA occurred in 22 patients (2.4%) and LVOTO (≥50 mmHg) in 281 (30.4%). HRR was 1.90 ± 0.40 (lowest quartile ≤ 1.61, highest quartile > 2.13). Higher resting heart rate (odds ratio 1.027, 95% CI: 1.018-1.036, < 0.001), older age (odds ratio 1.021, 95% CI: 1.009-1.033, < 0.001), lower exercise tolerance (mets, odds ratio 0.761, 95% CI: 0.708-0.817, 0.001) and resting LVOTO (odds ratio 1.504, 95% CI: 1.043-2.170, 0.029) predicted a reduced HRR. During a median follow-up of 89 months (interquartile range: 36-145 months), 90 all-cause deaths occurred. At multivariable analysis, lowest quartile HRR (Hazard ratio 2.354, 95% CI 1.116-4.968 = 0.025) and RWMA (Hazard ratio 3.279, 95% CI 1.441-7.461 0.004) independently predicted death, in addition to age (Hazard ratio 1.064, 95% CI 1.043-1.085 0.001) and maximal wall thickness (Hazard ratio 1.081, 95% CI 1.037-1.128, < 0.001).

Conclusions: A blunted HRR during ESE predicts survival independently of RWMA in HCM patients.
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http://dx.doi.org/10.3390/jcm10071347DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8037369PMC
March 2021

CarDiac magnEtic Resonance for prophylactic Implantable-cardioVerter defibrillAtor ThErapy in Non-Ischaemic dilated CardioMyopathy: an international Registry.

Europace 2021 Jul;23(7):1072-1083

Department of Cardiology, ASST Monza, P.O. Desio, Italy.

Aims: The aim of this registry was to evaluate the additional prognostic value of a composite cardiac magnetic resonance (CMR)-based risk score over standard-of-care (SOC) evaluation in a large cohort of consecutive unselected non-ischaemic cardiomyopathy (NICM) patients.

Methods And Results: In the DERIVATE registry (www.clinicaltrials.gov/registration: RCT#NCT03352648), 1000 (derivation cohort) and 508 (validation cohort) NICM patients with chronic heart failure (HF) and left ventricular ejection fraction <50% were included. All-cause mortality and major adverse arrhythmic cardiac events (MAACE) were the primary and secondary endpoints, respectively. During a median follow-up of 959 days, all-cause mortality and MAACE occurred in 72 (7%) and 93 (9%) patients, respectively. Age and >3 segments with midwall fibrosis on late gadolinium enhancement (LGE) were the only independent predictors of all-cause mortality (HR: 1.036, 95% CI: 1.0117-1.056, P < 0.001 and HR: 2.077, 95% CI: 1.211-3.562, P = 0.008, respectively). For MAACE, the independent predictors were male gender, left ventricular end-diastolic volume index by CMR (CMR-LVEDVi), and >3 segments with midwall fibrosis on LGE (HR: 2.131, 95% CI: 1.231-3.690, P = 0.007; HR: 3.161, 95% CI: 1.750-5.709, P < 0.001; and HR: 1.693, 95% CI: 1.084-2.644, P = 0.021, respectively). A composite clinical and CMR-based risk score provided a net reclassification improvement of 63.7% (P < 0.001) for MAACE occurrence when added to the model based on SOC evaluation. These findings were confirmed in the validation cohort.

Conclusion: In a large multicentre, multivendor cohort registry reflecting daily clinical practice in NICM work-up, a composite clinical and CMR-based risk score provides incremental prognostic value beyond SOC evaluation, which may have impact on the indication of implantable cardioverter-defibrillator implantation.
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http://dx.doi.org/10.1093/europace/euaa401DOI Listing
July 2021

Understanding eating choices among university students: A study using data from cafeteria cashiers' transactions.

Health Policy 2021 May 10;125(5):665-673. Epub 2021 Jan 10.

Institute of Management and Department of Excellence EMbeDS, Scuola Superiore Sant'Anna, Pisa, Italy.

Objective: To illustrate the use of automatically collected data from cashier transactions to understand eating habits among university students using cafeteria and to identify individual characteristics associated with the diverse behaviors.

Methods: The study was carried out at a large university located in Pisa, central Italy, using data about meals automatically recorded from cashier transaction meals during the academic year 2015-16 as well as data from the administrative archive of the university. A model-based clustering relying on multivariate beta distribution was used to cluster eating choices while multivariate multinomial logistic regressions were applied to identify variables associated to diverse clusters identified.

Results: Considering 4643 students and about 200,000 meals consumed, results suggest that healthy eaters represented a minority (11.2 %) of the study population while the large part of students composed their meals combining grains with processed food or proteins (32.7 %) and limiting the choice of fruit (42.9 %). Male gender and younger age were associated with eating behavior not in line with recommendations for a healthy diet.

Conclusions: Eating choice resulted to be "compromised" in most of students and specific characteristics associated with unhealthy choice were also identified that can help inform and target specific policy. The use of routinely collected data gives the opportunity to both cafeterias and university to take an active role in policy development.
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http://dx.doi.org/10.1016/j.healthpol.2020.12.019DOI Listing
May 2021

New Perspective to Improve Care of Patients with Infected Diabetic Foot Ulcer: Early Economic Impact of the Use of Photodynamic Therapy with RLP068 (Based) System.

Clinicoecon Outcomes Res 2021 26;13:135-144. Epub 2021 Feb 26.

Institute of Management, Scuola Superiore Sant'Anna, Pisa, Italy.

Objective: To perform an early economic evaluation of a system based on photodynamic advanced adjuvant therapy with photosensitizer RLP068/CI to facilitate the healing process of foot/leg skin lesions/ulcers with an excellent safety profile.

Design: An early short-term (10 weeks) cost-effectiveness and a budget impact analysis (over 5 years) comparing photodynamic therapy with photosensitizer RLP068/CI based (PDT-RLP068) system added to Standard of Care (SoC) vs SoC alone.

Setting: The Italian National Healthcare System perspective considering both the outpatient and the day-hospital regimen.

Participants: Hypothetical patients with diabetic foot infection (DFI) grades I/IIB.

Interventions: The PDT-RLP068 system as an add-on to Standard of Care (SoC) vs SoC alone as the first-line treatment for the management of DFIs.

Main Outcomes: Days within which the clinical target was achieved and direct health costs for patients' management.

Results: Additional costs generated by the use of the PDT-RLP068 system progressively decreased as time to reach the target induced by the novel system decreased. In the outpatient regimen, when time to reach clinical target decreased in the range 7-28 days, ICERs varied from about 1€ to 70€ for each additional day gained with clinical target achieved. The system was dominant when halving time to reach the target in the outpatient regimen and even for modest reduction of time in day-hospital regimen. In terms of budget impact, when considering day-hospital regimen, if the PDT-RLP068 based system allowed a shortened duration to reach the clinical target of between 7-28 days, BI was 8,100,000€ to 700,000€, with saving less than 2,000,000€ with 50% reduction of time. Considering the inpatient setting, the use of the PDT-RLP068 system would result in saving even with the modest impact on the time needed to activate the healing process.

Conclusion: The early economic evaluation performed suggested that, if the claimed effectiveness of the technology demonstrated in case reports and in preliminary clinical studies can be confirmed in larger population studies, and allowing for shortening of the time needed to activate the healing process, the PDT-RLP068 system could offer the chance to improve care for DFI patients without compromising the sustainability of the system.
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http://dx.doi.org/10.2147/CEOR.S274897DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7924247PMC
February 2021

Cost-Effectiveness of Direct Non-Vitamin K Oral Anticoagulants Versus Vitamin K Antagonists for the Management of Patients with Non-Valvular Atrial Fibrillation Based on Available "Real-World" Evidence: The Italian National Health System Perspective.

Clin Drug Investig 2021 Mar 15;41(3):255-267. Epub 2021 Feb 15.

Institute of Management, Scuola Superiore Sant'Anna, Piazza Martiri della Libertà, 33, 56127, Pisa, Italy.

Background And Objective: The increasing availability of real-world evidence (RWE) about safety and effectiveness of direct non-vitamin K oral anticoagulants (DOACs) for the management of atrial fibrillation (AF) offers the opportunity to better understand the clinical and economic implications of DOACs versus vitamin K antagonists (VKAs). The objective of this study was to compare the economic implications of DOACs and VKAs using data from real-world evidence in patients with AF.

Methods: A Markov model simulating the lifetime course of patients diagnosed with non-valvular AF was used to evaluate the cost-effectiveness of DOACs (i.e., rivaroxaban, dabigatran and apixaban) versus VKAs from the Italian National Health System (INHS) perspective. The model was made up of data from the literature and a meta-analysis of RWE on the incidence of stroke/systemic embolism (SE), major bleeding (MB), intracranial haemorrhage (ICH) and all-cause mortality (ACM); direct costs included drug costs, costs for drug monitoring, and management of events from official national lists. One-way and probabilistic sensitivity analyses (PSA) were used to assess the robustness of the results.

Results: Results from the meta-analysis showed that apixaban had a high probability of being the most effective for stroke/SE, MB and ACM. Despite their higher acquisition costs, the cost-effectiveness analysis showed all DOACs involved a saving when compared with VKAs, with per-patient savings ranging between €4647 (rivaroxaban) to €6086 (apixaban). Moreover, all DOACs indicated a gain both in quality-adjusted life-years and life-years. According to PSA, findings related to apixaban were consistent, while for dabigatran and rivaroxaban PSA revealed a higher degree of uncertainty.

Conclusions: The beneficial effect of DOACs on containing events showed in RWE had the potential to offset drug-related costs, thus improving the sustainability of treatment for non-valvular AF in daily clinical practice.
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http://dx.doi.org/10.1007/s40261-021-01002-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7946694PMC
March 2021

Minimally invasive distal pancreatectomy: a case-matched cost-analysis between robot-assisted surgery and direct manual laparoscopy.

Surg Endosc 2021 Feb 3. Epub 2021 Feb 3.

General Surgery Unit, Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Via Paradisa 2, 56125, Pisa, Italy.

Background: Few studies have reported a structured cost analysis of robotic distal pancreatectomy (RDP), and none have compared the relative costs between the robotic-assisted surgery (RAS) and the direct manual laparoscopy (DML) in this setting. The aim of the present study is to address this issue by comparing surgical outcomes and costs of RDP and laparoscopic distal pancreatectomies (LDP).

Methods: Eighty-eight RDP and 47 LDP performed between January 2008 and January 2020 were retrospectively analyzed. Three comparable groups of 35 patients each (Si-RDP-group, Xi-RDP group, LDP-group) were obtained matching 1:1 the RDP-groups with the LDP-group. Overall costs, including overall variable costs (OVC) and fixed costs were compared using generalized linear regression model adjusting for covariates.

Results: The conversion rate was significantly lower in the Si-RDP-group and Xi-RDP-group: 2.9% and 0%, respectively, versus 14.3% in the LDP-group (p = 0.045). Although not statistically significant, the mean operative time was lower in Xi-RDP-group: 226 min versus 262 min for Si-RDP-group and 247 min for LDP-group. The overall post-operative complications rate and the length of hospital stay (LOS) were not significantly different between the three groups. In LDP-group, the LOS of converted cases was significantly longer: 15.6 versus 9.8 days (p = 0.039). Overall costs of LDP-group were significantly lower than RDP-groups, (p < 0.001). At multivariate analysis OVC resulted no longer statistically significantly different between LDP-group and Xi-RDP-group (p = 0.099), and between LDP-group and the RDP-groups when the spleen preservation was indicated (p = 0.115 and p = 0.261 for Si-RDP-group and Xi-RDP-group, respectively).

Conclusions: RAS is more expensive than DML for DP because of higher acquisition and maintenance costs. The flattening of these differences considering only the variable costs, in a high-volume multidisciplinary center for RAS, suggests a possible optimization of the costs in this setting. RAS might be particularly indicated for minimally invasive DP when the spleen preservation is scheduled.
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http://dx.doi.org/10.1007/s00464-021-08332-1DOI Listing
February 2021

RarERN Path: a methodology towards the optimisation of patients' care pathways in rare and complex diseases developed within the European Reference Networks.

Orphanet J Rare Dis 2020 12 14;15(1):347. Epub 2020 Dec 14.

Institute of Management, Scuola Superiore Sant'Anna, Piazza Martiri della Libertà, 33, 56127, Pisa, Italy.

Background: In 2017, the European Commission has launched the European Reference Networks (ERNs), virtual networks involving healthcare providers across Europe. The aim of the ERNs is to tackle complex and rare diseases and conditions that require highly specialized treatment and a concentration of knowledge and resources. The ERN on rare and complex connective tissue and musculoskeletal diseases (ERN ReCONNET) is one of the 24 ERNs approved that aims to improve the management of Rare and Complex Connective Tissue and Musculoskeletal Diseases.

Objective: The RarERN Path methodology aims to create a single reference organisational model for patients' care pathways which, if applied in different contexts, helps to ensure an improved, cost-effective and patient-centred equal care to rare and complex diseases.

Methods: Starting from existing standard methods for the creation and elaboration of patients' care pathways, a specific methodology was created in order to take advantage of the distinctive and peculiar characteristics of the ERNs. Specifically, the development of the RarERN Path methodology involved different stakeholders: health economists, clinicians and researchers expert in rare and complex diseases, communication experts, experts in patients' involvement and narrative medicine and policy-makers.

Results: The RarERN Path methodology foresees six consecutive phases, each with different and specific aims. Specifically, the six phases are represented by: Phase 1-mapping of existing patients' care pathways and patients' stories; Phase 2-design of an optimised common patients' care pathway; Phase 3-consensus on an optimised common patients' care pathway; Phase 4-key performance indicators definition; Phase 5-refinement; Phase 6-pilot phase (optional).

Conclusion: The application of RarERN Path to the different disease-specific and geographical contexts would help to ensure an improved, cost-effective and patient-centred equal care to rare and complex diseases across Europe as well as a possible tangible action towards the integration of ERNs into the different European healthcare systems.
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http://dx.doi.org/10.1186/s13023-020-01631-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7734838PMC
December 2020

Feasibility and functional correlates of left atrial volume changes during stress echocardiography in chronic coronary syndromes.

Int J Cardiovasc Imaging 2021 Mar 15;37(3):953-964. Epub 2020 Oct 15.

Cardiology Department, Saint Petersburg State University Clinic, Saint Petersburg State University, St Petersburg, Russian Federation.

An enlarged left atrial volume index (LAVI) at rest mirrors increased LA pressure and/or impairment of LA function. A cardiovascular stress may acutely modify left atrial volume (LAV) within minutes. Aim of this study was to assess the feasibility and functional correlates of LAV-stress echocardiography (SE) Out of 514 subjects referred to 10 quality-controlled labs, LAV-SE was completed in 490 (359 male, age 67 ± 12 years) with suspected or known chronic coronary syndromes (n = 462) or asymptomatic controls (n = 28). The utilized stress was exercise in 177, vasodilator in 167, dobutamine in 146. LAV was measured with the biplane disk summation method. SE was performed with the ABCDE protocol. The intra-observer and inter-observer LAV variability were 5% and 8%, respectively. ∆-LAVI changes (stress-rest) were negatively correlated with resting LAVI (r = - 0.271, p < 0.001) and heart rate reserve (r = -.239, p < 0.001). LAV-dilators were defined as those with stress-rest increase ≥ 6.8 ml/m, a cutoff derived from a calculated reference change value above the biological, analytical and observer variability of LAVI. LAV dilation occurred in 56 patients (11%), more frequently with exercise (16%) and dipyridamole (13%) compared to dobutamine (4%, p < 0.01). At multivariable logistic regression analysis, B-lines ≥ 2 (OR: 2.586, 95% CI = 1.1293-5.169, p = 0.007) and abnormal contractile reserve (OR: 2.207, 95% CI = 1.111-4.386, p = 0.024) were associated with LAV dilation. In conclusion, LAV-SE is feasible with high success rate and low variability in patients with chronic coronary syndromes. LAV dilation is more likely with reduced left ventricular contractile reserve and pulmonary congestion.
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http://dx.doi.org/10.1007/s10554-020-02071-5DOI Listing
March 2021

Utilisation patterns and clinical impact of the introduction of infliximab-biosimilar in Tuscany, Italy: real world evidence following the recommendation of switching for non-medical reasons.

Clin Exp Rheumatol 2021 Jul-Aug;39(4):753-762. Epub 2020 Aug 5.

Pharmacology and Pharmacovigilance Unit, Department of Clinical and Experimental Medicine, and Unit of Adverse Drug Reactions Monitoring, University Hospital of Pisa, Italy.

Objectives: This study was aimed at assessing the impact of a non-medical recommendation on drug-utilisation patterns and clinical outcomes in a central Region of Italy (Tuscany).

Methods: We performed a pre-post study on data collected in Tuscan healthcare administrative databases. We included patients with diagnosis of rheumatoid arthritis, or psoriatic arthritis, or ankylosing spondylitis, or ulcerative colitis, or Crohn's disease, or psoriasis. The first analysis compared patients treated with infliximab on January 1st, 2013 (originator only available) to those on January 1st, 2016 (both originator and biosimilar available). The second analysis compared infliximab-originator users with infliximab-biosimilar ones. Adjusted odds ratios (OR) of persistence on treatment, Emergency Department (ED) admissions, hospitalisations and specialist visits were calculated.

Results: The first analysis included 606 patients and the second 434. In both analyses, we did not observe any significant difference in persistence. In the first analysis, the 2016 infliximab-originator cohort showed a significant association with the risk of having at least one ED admission (OR 1.54, 95% CI 1.02 to 2.31). A significant difference of accessing a specialist visit (more frequently rheumatologic) was observed in the 2016 cohort (OR 1.52, 95% CI 1.05 to 2.20). In the second analysis, the risk of having at least one hospitalisation decreased significantly in switchers to infliximab-biosimilar (OR 0.49, 95% CI 0.26 to 0.96).

Conclusions: Our study showed no relevant changes in the clinical outcomes following the introduction of infliximab-biosimilar. The few observed differences observed can be explained mainly by a selective switching to infliximab-biosimilar in patients with lower burden of disease.
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July 2021

Topic Modeling and User Network Analysis on Twitter during World Lupus Awareness Day.

Int J Environ Res Public Health 2020 07 28;17(15). Epub 2020 Jul 28.

Institute of Management, Scuola Superiore Sant'Anna, 56127 Pisa, Italy.

Twitter is increasingly used by individuals and organizations to broadcast their feelings and practices, providing access to samples of spontaneously expressed opinions on all sorts of themes. Social media offers an additional source of data to unlock information supporting new insights disclosures, particularly for public health purposes. Systemic lupus erythematosus (SLE) is a complex, systemic autoimmune disease that remains a major challenge in therapeutic diagnostic and treatment management. When supporting patients with such a complex disease, sharing information through social media can play an important role in creating better healthcare services. This study explores the nature of topics posted by users and organizations on Twitter during world Lupus day to extract latent topics that occur in tweet texts and to identify what information is most commonly discussed among users. We identified online influencers and opinion leaders who discussed different topics. During this analysis, we found two different types of influencers that employed different narratives about the communities they belong to. Therefore, this study identifies hidden information for healthcare decision-makers and provides a detailed model of the implications for healthcare organizations to detect, understand, and define hidden content behind large collections of text.
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http://dx.doi.org/10.3390/ijerph17155440DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7432829PMC
July 2020

Scoping review and bibliometric analysis of Big Data applications for Medication adherence: an explorative methodological study to enhance consistency in literature.

BMC Health Serv Res 2020 Jul 24;20(1):688. Epub 2020 Jul 24.

Institute of Management, Scuola Superiore Sant'Anna, Pisa, Italy.

Background: Medication adherence has been studied in different settings, with different approaches, and applying different methodologies. Nevertheless, our knowledge and efficacy are quite limited in terms of measuring and evaluating all the variables and components that affect the management of medication adherence regimes as a complex phenomenon. The study aim is mapping the state-of-the-art of medication adherence measurement and assessment methods applied in chronic conditions. Specifically, we are interested in what methods and assessment procedures are currently used to tackle medication adherence. We explore whether Big Data techniques are adopted to improve decision-making procedures regarding patients' adherence, and the possible role of digital technologies in supporting interventions for improving patient adherence and avoiding waste or harm.

Methods: A scoping literature review and bibliometric analysis were used. Arksey and O'Malley's framework was adopted to scope the review process, and a bibliometric analysis was applied to observe the evolution of the scientific literature and identify specific characteristics of the related knowledge domain.

Results: A total of 533 articles were retrieved from the Scopus academic database and selected for the bibliometric analysis. Sixty-one studies were identified and included in the final analysis. The Morisky medication adherence scale (36%) was the most frequently adopted baseline measurement tool, and cardiovascular/hypertension disease, the most investigated illness (38%). Heterogeneous findings emerged from the types of study design and the statistical methodologies used to assess and compare the results.

Conclusions: Our findings reveal a lack of Big Data applications currently deployed to address or measure medication adherence in chronic conditions. Our study proposes a general framework to select the methods, measurements and the corpus of variables in which the treatment regime can be analyzed.
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http://dx.doi.org/10.1186/s12913-020-05544-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7379348PMC
July 2020

Lung Ultrasound and Pulmonary Congestion During Stress Echocardiography.

JACC Cardiovasc Imaging 2020 10 15;13(10):2085-2095. Epub 2020 Jul 15.

Clinical Cardiology Department, Clinical Hospital Zvezdara, Medical School, University of Belgrade, Belgrade, Serbia.

Objectives: The purpose of this study was to assess the functional and prognostic correlates of B-lines during stress echocardiography (SE).

Background: B-profile detected by lung ultrasound (LUS) is a sign of pulmonary congestion during SE.

Methods: The authors prospectively performed transthoracic echocardiography (TTE) and LUS in 2,145 patients referred for exercise (n = 1,012), vasodilator (n = 1,054), or dobutamine (n = 79) SE in 11 certified centers. B-lines were evaluated in a 4-site simplified scan (each site scored from 0: A-lines to 10: white lung for coalescing B-lines). During stress the following were also analyzed: stress-induced new regional wall motion abnormalities in 2 contiguous segments; reduced left ventricular contractile reserve (peak/rest based on force, ≤2.0 for exercise and dobutamine, ≤1.1 for vasodilators); and abnormal coronary flow velocity reserve ≤2.0, assessed by pulsed-wave Doppler sampling in left anterior descending coronary artery and abnormal heart rate reserve (peak/rest heart rate) ≤1.80 for exercise and dobutamine (≤1.22 for vasodilators). All patients completed follow-up.

Results: According to B-lines at peak stress patients were divided into 4 different groups: group I, absence of stress B-lines (score: 0 to 1; n = 1,389; 64.7%); group II, mild B-lines (score: 2 to 4; n = 428; 20%); group III, moderate B-lines (score: 5 to 9; n = 209; 9.7%) and group IV, severe B-lines (score: ≥10; n = 119; 5.4%). During median follow-up of 15.2 months (interquartile range: 12 to 20 months) there were 38 deaths and 28 nonfatal myocardial infarctions in 64 patients. At multivariable analysis, severe stress B-lines (hazard ratio [HR]: 3.544; 95% confidence interval [CI]: 1.466 to 8.687; p = 0.006), abnormal heart rate reserve (HR: 2.276; 95% CI: 1.215 to 4.262; p = 0.010), abnormal coronary flow velocity reserve (HR: 2.178; 95% CI: 1.059 to 4.479; p = 0.034), and age (HR: 1.031; 95% CI: 1.002 to 1.062; p = 0.037) were independent predictors of death and nonfatal myocardial infarction.

Conclusions: Severe stress B-lines predict death and nonfatal myocardial infarction. (Stress Echo 2020-The International Stress Echo Study [SE2020]; NCT03049995).
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http://dx.doi.org/10.1016/j.jcmg.2020.04.020DOI Listing
October 2020

Translation, cultural adaptation and validation of the Italian version of the Brief Index of Lupus Damage: the BILDit.

Lupus 2020 Sep 13;29(10):1198-1205. Epub 2020 Jul 13.

Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.

Objectives: The Brief Index of Lupus Damage (BILD) is an instrument of self-evaluation of organ damage for systemic lupus erythematosus (SLE) patients. The objectives of this study were the translation, cultural adaptation and validation of the Italian version of the BILD (BILDit).

Methods: The process of translation and cultural adaptation followed published guidelines. The BILDit was pretested in a pilot study with 30 SLE patients in order to evaluate acceptability, reliability, comprehension and feasibility, and then validated in consecutive SLE patients attending our clinic.

Results: A total of 167 SLE patients were enrolled. In the pilot study, the BILDit demonstrated good acceptability, feasibility and comprehensibility and a very high degree of reliability (Cronbach's α = 1). In the validation cohort, the BILDit showed a significant positive correlation with the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI; ρ = 0.69;  < 0.001). Analysing the item-by-item correlation between the BILDit and the SDI, a good correlation ( < 0.001) was found for 73.1% of the items. In the multivariate analysis, the BILDit showed a significant positive correlation with age and disease duration ( < 0.01).

Conclusions: The BILDit seems to be an acceptable and reliable instrument for patient self-evaluation of disease damage, with a good correlation with the SDI. It can be considered as a screening tool for the evaluation of organ damage starting from the patient's perceptive.
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http://dx.doi.org/10.1177/0961203320940012DOI Listing
September 2020

Myocardial Scar by Pulse-Cancellation Echocardiography Is Independently Associated with Appropriate Defibrillator Intervention for Primary Prevention after Myocardial Infarction.

J Am Soc Echocardiogr 2020 09 1;33(9):1123-1131. Epub 2020 Jul 1.

Parma University Hospital, Parma, Italy.

Background: Myocardial scar burden impacts prognosis in patients with coronary artery disease who have experienced a myocardial infarction (MI). This has been demonstrated by late gadolinium enhancement cardiac magnetic resonance. Clinical experience with echocardiography suggests that the reflected ultrasound signal is enhanced in infarcted myocardial segments. Scar imaging with an ultrasound multipulse scheme (eScar) has been preliminarily validated in prior studies.

Objective: To assess whether scar burden, as detected by eScar, is associated with implantable cardioverter-defibrillator (ICD) shocks in post-MI patients.

Methods: We retrospectively selected 50 post-MI patients with an ejection fraction <35% who received an ICD for primary prevention and subsequently had at least one appropriate shock (cases). These were compared with 50 post-MI patients, matched for clinical variables and ejection fraction, who never experienced an appropriate defibrillator shock (controls). Subjects were assessed with the eScar technique at the time of implantation or during follow-up.

Results: An eScar was present in ≥1 segment in 40 of 50 (80%) cases vs 26 of 50 (52%) controls and was associated with appropriate ICD shocks (P = .004). Receiver operating characteristic curve analysis, using a threshold of ≥3 segments by eScar, showed an area under the curve (AUC) of 0.715. On models including clinical and echocardiographic variables, eScar remained significantly associated with ICD shocks (P = .050 or P = .033 depending on the model). Adding eScar to a multivariate logistic regression model including indexed left ventricular end-systolic volume led to an increase in AUC from 0.734 to 0.782 (P = .049), while substituting indexed left ventricular end-diastolic volume for indexed left ventricular end-systolic volume resulted in a nonsignificant increase in AUC from 0.747 to 0.785 (P = .098).

Conclusions: Presence and extent of eScar were independently associated with appropriate ICD shocks in this study of patients with prior MI and reduced ejection fraction. However, the addition of eScar assessment to the clinical multivariable model that included also indexed left ventricular end-diastolic volume did not provide significant incremental value.
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http://dx.doi.org/10.1016/j.echo.2020.04.020DOI Listing
September 2020

Visually assessed coronary and cardiac calcium outperforms perfusion data during scintigraphy in the prediction of adverse outcomes.

Int J Cardiol 2020 08 12;312:123-128. Epub 2020 Mar 12.

Istituto Sant'anna, Pisa, Italy.

Objectives: To determine whether calcifications of the coronary arteries (coronary artery calcium 0 to 4 score), or extending the assessment also to cardiac valves and thoracic aorta (overall calcium 0 to 8 score), as seen on computed tomography for attenuation correction during stress-scintigraphy (SPECT-CT), are associated with total mortality and non-fatal myocardial infarction. We aimed to assess whether these calcifications added to the prognostic value of SPECT imaging.

Background: The presence/amount of calcium in the coronary arteries, but also in the heart valves and aorta, has been associated with cardiovascular (CV) and all-cause mortality. This information can be obtained during SPECT-CT examinations, where low resolution CT images are co-registered for attenuation correction of myocardial perfusion, but then discarded.

Methods: Clinical data were collected on 353 consecutive patients submitted to stress SPECT-CT between Sept 2010 and Oct 2012, for suspected coronary artery disease (CAD). Follow-up data on outcomes were collected retrospectively.

Results: Mean age was 72 and 58% were male. Mean follow-up was 6.4 years, during which 48 subjects died (15 from CV causes) and 10 had non-fatal myocardial infarction (MI). Reversible perfusion defects were detected in 55 patients (15.6%), 39 of whom (11%) had >mild defects. The presence of a calcium score > 1 in the attenuation correction images was the strongest univariate predictor of all-cause death or MI (hazard ratio 7.21, p < .001). On multivariate analysis, controlling for age, gender and myocardial perfusion defects an overall calcium score > 2 remained a predictor of all-cause death or non-fatal MI (hazard ratio 4.12, p < .001).

Conclusions: Visual assessment of coronary or overall coronary, cardiac and aortic calcium in the CT images used for attenuation correction during SPECT-CT is feasible and reproducible. It was strongly associated with all-cause death and MI, even after controlling for clinical variables and myocardial perfusion data. This simple visual calcium assessment does not add additional costs or radiation, and may significantly improve risk-assessment of patients with suspected CAD undergoing SPECT-CT.

Condensed Abstract: Calcium in the coronary arteries, heart valves and aorta has been associated with worse prognosis. We sought to determine whether assessment of such calcifications on computed tomography images (co-registered for myocardial perfusion attenuation correction and then discarded) are independently associated with long-term outcome on top of available data. We enrolled 353 consecutive patients, referred for suspected coronary artery disease. An overall calcium score > 1 in the attenuation correction images was the strongest univariate (hazard ratio 7.21, p < .001) and multivariate predictor of all-cause death or non-fatal MI (hazard ratio 4.12, p < .001), even after controlling for clinical variables and myocardial perfusion data.
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http://dx.doi.org/10.1016/j.ijcard.2020.03.032DOI Listing
August 2020

Coronary Flow Velocity Reserve Reduction Is Associated with Cardiovascular, Cancer, and Noncancer, Noncardiovascular Mortality.

J Am Soc Echocardiogr 2020 05 12;33(5):594-603. Epub 2020 Mar 12.

Istituto Sant'anna, Pisa, Italy.

Background: Coronary flow velocity reserve (CFVR) measured in the left anterior descending artery during high-dose vasodilator stress echocardiography interrogates both epicardial and microcirculatory coronary function and has been inversely associated with chronic inflammation and microvascular dysfunction, as well as with the presence of obstructive coronary artery disease. Microvascular dysfunction and chronic inflammation are common mechanisms of disease in cardiovascular (CV) and non-CV conditions. We aimed to assess whether CFVR is associated with all-cause death, but more specifically with CV, cancer, and non-CV and noncancer (NCVNC) mortality, independently and increasingly over other demographic, clinical, and echocardiography variables.

Methods: One thousand two patients who underwent stress echocardiography were followed for a median of 8.2 years, with clinical, regional wall motion abnormalities (RWMAs), and CFVR data. The independent prognostic value of RWMA and CFVR regarding CV, cancer, or NCVNC mortality was evaluated adjusting for clinical variables. A prespecified subgroup of subjects with no RWMA or revascularization procedures during follow-up was also analyzed (n = 752), to exclude most participants with possible coronary artery disease and remove such confounding from the assessment of the potential association of CFVR and mortality.

Results: A total of 161 patients (16%) died, 63 deaths being CV (39%), 52 from cancer (32%), and 46 (29%) from NCVNC causes. In comparison to CV mortality, cancer and NCVNC mortality were not associated with an ischemic RWMA at univariable analysis, while a CFVR < 2 was significantly associated with each category of cause-specific mortality. A CFVR < 2 or ≥2 separated a group of patients with 8-year 14.6% versus 1.2% CV mortality, 10.3% versus 0.4% cancer mortality, and 9.5% versus 1.5% NCVNC mortality.

Conclusions: The reduction of CFVR is independently associated with CV, cancer, and NCVNC death in a population clinically referred for suspected/known coronary artery disease. CFVR can act as a marker or a mechanism preceding and predicting mortality from a wide variety of diseases.
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http://dx.doi.org/10.1016/j.echo.2020.01.007DOI Listing
May 2020

Diagnostic performance of non-invasive imaging for stable coronary artery disease: A meta-analysis.

Int J Cardiol 2020 02 6;300:276-281. Epub 2019 Nov 6.

Department of Emergency and Organ Transplantation, University of Bari, Italy; School of Public Health, University of Sydney, Australia; Diaverum Medical Scientific Office, Lund, Sweden.

Background: To determine diagnostic performance of non-invasive tests using invasive fractional flow reserve (FFR) as reference standard for coronary artery disease (CAD).

Methods: Medline, Embase, and citations of articles, guidelines, and reviews for studies were used to compare non-invasive tests with invasive FFR for suspected CAD published through March 2017.

Results: Seventy-seven studies met inclusion criteria. The diagnostic test with the highest sensitivity to detect a functionally significant coronary lesion was coronary computed tomography (CT) angiography [88%(85%-90%)], followed by FFR derived from coronary CT angiography (FFR) [85%(81%-88%)], positron emission tomography (PET) [85%(82%-88%)], stress cardiac magnetic resonance (stress CMR) [81%(79%-84%)], stress myocardial CT perfusion combined with coronary CT angiography [79%(74%-83%)], stress myocardial CT perfusion [77%(73%-80%)], stress echocardiography (Echo) [72%(64%-78%)] and stress single-photon emission computed tomography (SPECT) [64%(60%-68%)]. Specificity to rule out CAD was highest for stress myocardial CT perfusion added to coronary CT angiography [91%(88%-93%)], stress CMR [91%(90%-93%)], and PET [87%(86%-89%)].

Conclusion: A negative coronary CT angiography has a higher test performance than other index tests to exclude clinically-important CAD. A positive stress myocardial CT perfusion added to coronary CT angiography, stress cardiac MR, and PET have a higher test performance to identify patients requiring invasive coronary artery evaluation.
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http://dx.doi.org/10.1016/j.ijcard.2019.10.046DOI Listing
February 2020

Anatomical and functional coronary imaging to predict long-term outcome in patients with suspected coronary artery disease: the EVINCI-outcome study.

Eur Heart J Cardiovasc Imaging 2020 10;21(11):1273-1282

PET Center, Turku University Hospital and University of Turku, Kiinamyllynkatu 4-8, 20521 Turku, Finland.

Aims: To investigate the prognostic relevance of coronary anatomy, coronary function, and early revascularization in patients with stable coronary artery disease (CAD).

Methods And Results: From March 2009 to June 2012, 430 patients with suspected CAD (61 ± 9 years, 62% men) underwent coronary anatomical imaging by computed tomography coronary angiography (CTCA) and coronary functional imaging followed by invasive coronary angiography (ICA) if at least one non-invasive test was abnormal. Obstructive CAD was documented by ICA in 119 patients and 90 were revascularized within 90 days of enrolment. Core laboratory analysis showed that 134 patients had obstructive CAD by CTCA (>50% stenosis in major coronary vessels) and 79 significant ischaemia by functional imaging [>10% left ventricular (LV) myocardium]. Over mean follow-up of 4.4 years, major adverse events (AEs) (all-cause death, non-fatal myocardial infarction, or hospital admission for unstable angina or heart failure) or AEs plus late revascularization (LR) occurred in 40 (9.3%) and 58 (13.5%) patients, respectively. Obstructive CAD at CTCA was the only independent imaging predictor of AEs [hazard ratio (HR) 3.2, 95% confidence interval (CI) 1.10-9.30; P = 0.033] and AEs plus LR (HR 4.3, 95% CI 1.56-11.81; P = 0.005). Patients with CAD in whom early revascularization was performed in the presence of ischaemia and deferred in its absence had fewer AEs, similar to patients without CAD (HR 2.0, 95% CI 0.71-5.51; P = 0.195).

Conclusion: Obstructive CAD imaged by CTCA is an independent predictor of clinical outcome. Early management of CAD targeted to the combined anatomical and functional disease phenotype improves clinical outcome.
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http://dx.doi.org/10.1093/ehjci/jez248DOI Listing
October 2020

Association of PCSK9 plasma levels with metabolic patterns and coronary atherosclerosis in patients with stable angina.

Cardiovasc Diabetol 2019 10 31;18(1):144. Epub 2019 Oct 31.

Fondazione Toscana G. Monasterio, Pisa, Italy.

Objective: Aim of this study was to evaluate the relationship of plasma PCSK9 with metabolic and inflammatory profile and coronary atherosclerotic burden in patients with suspected CAD enrolled in the EVINCI study.

Methods: PCSK9 was measured in 539 patients (60.3 ± 8.6 years, 256 males) with symptoms of CAD characterized by risk factors, bio-humoral profiles, and treatment. N = 412 patients underwent coronary computed tomography angiography (CTA) to assess the presence and characteristics of coronary atherosclerosis. A CTA score, combining extent, severity, composition, and location of plaques was computed.

Results: Patients were divided according to PCSK9 quartiles: I (< 136 ng/mL), II-III (136-266 ng/mL), and IV quartile (> 266 ng/mL). Compared with patients in quartile IV, patients in quartile I had a higher prevalence of the metabolic syndrome and higher values of body mass index. LDL- and HDL-cholesterol were significantly lower in patients in the quartile I than in those in quartile IV. Coronary CTA documented normal vessels in 30% and obstructive CAD in 35% of cases without differences among PCSK9 quartiles. Compared with patients with the highest levels, patients with the lowest PCSK9 levels had a higher CTA score mainly due to higher number of mixed non-obstructive coronary plaques. At multivariable analysis including clinical, medications, and lipid variables, PCSK9 was an independent predictor of the CTA score (coefficient - 0.129, SE 0.03, P < 0.0001), together with age, male gender, statins, interleukin-6, and leptin.

Conclusion: In patients with stable CAD, low PCSK9 plasma levels are associated with a particular metabolic phenotype (low HDL cholesterol, the metabolic syndrome, obesity, insulin resistance and diabetes) and diffuse non-obstructive coronary atherosclerosis. Trial registration ClinicalTrials.gov NCT00979199. Registered September 17, 2009.
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http://dx.doi.org/10.1186/s12933-019-0949-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6824037PMC
October 2019

Correction to: Cost‑effectiveness analysis of stand‑alone or combined non‑invasive imaging tests for the diagnosis of stable coronary artery disease: results from the EVINCI study.

Eur J Health Econ 2019 Dec;20(9):1451

Institute of Management, Scuola Superiore Sant'Anna, Piazza Martiri della Libertà n. 33, 56127, Pisa, Italy.

In the Published article, the value in the abstract has been published incorrectly. The correct abstract section is as follows.
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http://dx.doi.org/10.1007/s10198-019-01128-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6943386PMC
December 2019

Associations Between Classification Criteria Items in Systemic Lupus Erythematosus.

Arthritis Care Res (Hoboken) 2020 12 7;72(12):1820-1826. Epub 2020 Nov 7.

University of Pisa, Pisa, Italy.

Objective: A project aimed at developing new classification criteria for systemic lupus erythematosus (SLE) is based on weighted criteria that include both laboratory and clinical items. Combinations of certain symptoms may occur commonly in SLE, which provides an argument against independently counting these items. The current study was undertaken to evaluate the interrelationship between candidate criteria items in the International Early SLE cohort and in the Euro-Lupus cohort.

Methods: The International Early SLE cohort included 389 patients, who were diagnosed within 3 years prior to the study. Data on the ACR's 1997 update of the SLE revised criteria, the Systemic Lupus International Collaborating Clinics 2012 criteria, and on 30 additional items were collected. To evaluate the interrelationship of the criteria, a tetrachoric correlation was used to assess the degree of association between different manifestations in the same organ system. The correlations identified in the International Early SLE cohort were validated in the Euro-Lupus cohort.

Results: A few relevant correlations were observed among specific clinical cutaneous manifestations (in particular, malar rash correlated with photosensitivity, alopecia, and oral ulcers) and serologic manifestations (anti-Sm and anti-double-stranded DNA and anti-RNA polymerase, anti-Ro and anti-La, and antiphospholipid antibodies), and these results were validated in the Euro-Lupus cohort. The associations within the mucocutaneous domain, hematologic and the specific autoantibodies suggest that within a single domain only the highest ranking item should be counted to avoid overrepresentation.

Conclusion: Some of the candidate SLE criteria cluster within domains. Given these interrelationships, multiple criteria within a domain should not be independently counted. These results are important to consider for the structure of new SLE classification criteria.
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http://dx.doi.org/10.1002/acr.24078DOI Listing
December 2020

Standard echocardiography versus very-low mechanical index contrast-imaging: left ventricle volumes and ejection fraction multi-reader variability and reference values in a subgroup with no risk factors or cardiac disease.

Heart Vessels 2020 Apr 17;35(4):544-554. Epub 2019 Sep 17.

Parma University Hospital, Via Gramsci 14, 43123, Parma, Italy.

We retrospectively assessed the rest-phase images of 300 contrast stress- echocardiograms, during which very-low mechanical index (VLMI) imaging with ultrasound enhancing agents (UEAs) was routinely acquired in addition to greyscale echocardiography; intra- and inter-reader variability for left ventricle (LV) volumes and ejection fraction (LVEF) at rest was established in the overall cohort and normal values were calculated in the subset of subjects with no cardiac risk factors or cardiac disease and a normal stress-echocardiogram. Current recommendations for chamber quantification using echocardiography advise the use of UEAs in case of insufficient quality of endocardial visualization, but normal values for LV volumes and LVEF using UEAs have never been published using currently recommended VLMI method. Single-centre retrospective study, enrolling subjects referred to contrast stress- echocardiography for suspect coronary artery disease, including the acquisition of both standard 2D greyscale and bolus UEAs with VLMI, regardless of the image quality. This enables offline measurement of the LV volumes and LVEF for both greyscale and UEAs-VLMI images at rest in all subjects. Images were allocated to 3 readers in random order. Normal range for LV volumes and LVEF was also derived in a subset of apparently healthy subjects. In the 298 exams finally assessed, measurement variability among the three readers was lower with UEAs-VLMI, in particular for end-systolic volumes (intra-class correlation coefficient for concordance improved from 0.855 to 0.916, for LVEF from 0.68 to 0.783, p < 0.01), intra- observer variability reduced (Lin's correlation coefficient for LVEF from 0.747 to 0.857, p < 0.01). Normal mean indexed LV end-diastolic volume with UEAs-VLMI, compared to greyscale imaging, was + 14 ml/m, while LVEF was + 5 to + 6% points. This is the largest study specifically addressing UEAs-VLMI imaging and comparing data with standard greyscale imaging; it demonstrates a reduction in measurement variability of LV volumes and LVEF. Normal reference values for VLMI ultrasound are reported for the first time in comparison with greyscale values.
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http://dx.doi.org/10.1007/s00380-019-01506-xDOI Listing
April 2020

Cost-effectiveness analysis of stand-alone or combined non-invasive imaging tests for the diagnosis of stable coronary artery disease: results from the EVINCI study.

Eur J Health Econ 2019 Dec 13;20(9):1437-1449. Epub 2019 Aug 13.

Institute of Management, Scuola Superiore Sant'Anna, Piazza Martiri della Libertà n. 33, 56127, Pisa, Italy.

Aim: This study aimed at evaluating the cost-effectiveness of different non-invasive imaging-guided strategies for the diagnosis of obstructive coronary artery disease (CAD) in a European population of patients from the Evaluation of Integrated Cardiac Imaging in Ischemic Heart Disease (EVINCI) study.

Methods And Results: Cost-effectiveness analysis was performed in 350 patients (209 males, mean age 59 ± 9 years) with symptoms of suspected stable CAD undergoing computed tomography coronary angiography (CTCA) and at least one cardiac imaging stress-test prior to invasive coronary angiography (ICA) and in whom imaging exams were analysed at dedicated core laboratories. Stand-alone stress-tests or combined non-invasive strategies, when the first exam was uncertain, were compared. The diagnostic end-point was obstructive CAD defined as > 50% stenosis at quantitative ICA in the left main or at least one major coronary vessel. Effectiveness was defined as the percentage of correct diagnosis (cd) and costs were calculated using country-specific reimbursements. Incremental cost-effectiveness ratios (ICERs) were obtained using per-patient data and considering "no-imaging" as reference. The overall prevalence of obstructive CAD was 28%. Strategies combining CTCA followed by stress ECHO, SPECT, PET, or stress CMR followed by CTCA, were all cost-effective. ICERs values indicated cost saving from - 969€/cd for CMR-CTCA to - 1490€/cd for CTCA-PET, - 3092€/cd for CTCA-SPECT and - 3776€/cd for CTCA-ECHO. Similarly when considering early revascularization as effectiveness measure.

Conclusion: In patients with suspected stable CAD and low prevalence of disease, combined non-invasive strategies with CTCA and stress-imaging are cost-effective as gatekeepers to ICA and to select candidates for early revascularization.
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http://dx.doi.org/10.1007/s10198-019-01096-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6856023PMC
December 2019

Early or deferred cardiovascular magnetic resonance after ST-segment-elevation myocardial infarction for effective risk stratification.

Eur Heart J Cardiovasc Imaging 2020 06;21(6):632-639

Radiology Department, Gasthuisberg University Hospitals, Herestraat 49, 3000 Leuven, Belgium.

Aims: In ST-segment-elevation myocardial infarction (STEMI), cardiovascular magnetic resonance (CMR) holds the potentiality to improve risk stratification in addition to Thrombolysis in Myocardial Infarction (TIMI) risk score. Nevertheless, the optimal timing for CMR after STEMI remains poorly defined. We aim at comparing the prognostic performance of three stratification strategies according to the timing of CMR after STEMI.

Methods And Results: The population of this prospective registry-based study included 492 reperfused STEMI patients. All patients underwent post-reperfusion (median: 4 days post-STEMI) and follow-up (median: 4.8 months post-STEMI) CMR. Left ventricular (LV) volumes, function, infarct size, and microvascular obstruction extent were quantified. Primary endpoint was a composite of all-death and heart failure (HF) hospitalization. Baseline-to-follow-up percentage increase of LV end-diastolic (EDV; ΔLV-EDV) ≥20% or end-systolic volumes (ESV; ΔLV-ESV) ≥15% were tested against outcome. Three multivariate models were developed including TIMI risk score plus early post-STEMI (early-CMR) or follow-up CMR (deferred-CMR) or both CMRs parameters along with adverse LV remodelling (paired-CMRs). During a median follow-up of 8.3 years, the primary endpoint occurred in 84 patients (47 deaths; 37 HF hospitalizations). Early-CMR, deferred-CMR, and paired-CMR demonstrated similar predictive value for the primary endpoint (C-statistic: 0.726, 0.728, and 0.738, respectively; P = 0.663). ΔLV-EDV ≥20% or ΔLV-ESV ≥15% were unadjusted outcome predictors (hazard ratio: 2.020 and 2.032, respectively; P = 0.002 for both) but lost their predictive value when corrected for other covariates in paired-CMR model.

Conclusion: In STEMI patients, early-, deferred-, or paired-CMR were equivalent stratification strategies for outcome prediction. Adverse LV remodelling parameters were not independent prognosticators.
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http://dx.doi.org/10.1093/ehjci/jez179DOI Listing
June 2020

Glucocorticoid withdrawal in systemic lupus erythematosus: are remission and low disease activity reliable starting points for stopping treatment? A real-life experience.

RMD Open 2019 11;5(2):e000916. Epub 2019 Jun 11.

Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.

Objectives: To evaluate the proportion of patients who have successfully withdrawn glucocorticoids (GCs) in a longitudinal cohort of patients with systemic lupus erythematosus (SLE) over a period of 6 years; to evaluate patient characteristics during GC withdrawal in relation to existing definitions of remission and Lupus Low Disease Activity State (LLDAS); and to evaluate the occurrence of flares after GC withdrawal.

Methods: Patients who attempted GC withdrawal were identified for the cohort, and the following information was assessed during withdrawal attempts: date of last disease flare, disease activity and damage and ongoing treatment. Information regarding the occurrence of disease flares after GC withdrawal was also recorded for patients who successfully stopped treatment.Definitions of remission were applied to GC withdrawal in line with European consensus criteria (Definitions of remission in SLE [DORIS]) and LLDAS in line with the Asian Pacific Lupus Consortium definition.

Results: 148 patients were involved in the study; GC withdrawal was attempted in 91 patients (61.5%) with 77 patients (84.6%) successfully stopping GCs. At the beginning of the GC reduction, the majority of patients were in complete or clinical remission (48.9% and 39.6%, respectively). Disease activity was significantly lower in patients who successfully stopped GCs, and the proportion of patients in complete remission was higher (54.2%) with respect to patients who failed in their attempt. Among patients who stopped GCs, 18 flares were recorded after a median of 1 year. The time period since the last flare was shorter in patients who experienced flares with respect to patients who did not flare (mean 0.93 years vs 6.0, p<0.001).

Conclusions: GC withdrawal is an achievable goal in SLE and may be attempted after a long-term remission or LLDAS to protect the patient from disease flares.
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http://dx.doi.org/10.1136/rmdopen-2019-000916DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6579574PMC
April 2020

Association of coronary artery Doppler-echocardiography diastolic-systolic velocity ratio at rest with obstructive coronary artery stenosis on the left main or left anterior descending coronary artery.

Int J Cardiol 2019 04 1;281:1-7. Epub 2019 Feb 1.

Parma University Hospital, Via Gramsci 14, 43123 Parma, Italy.

Background: We assessed whether the non-invasive measure of peak diastolic-systolic velocity ratio (rDSVR) at rest on the left anterior descending artery (LAD) using Doppler transthoracic echocardiography is associated with obstructive coronary artery disease (CAD) on the LAD and left main (LM) arteries. We compared rDSVR diagnostic accuracy with stress wall motion (WM) and coronary flow reserve (CFR-LAD), in a group of subjects who underwent contrast stress-echocardiography (cSE) and coronary angiography within 3 months.

Methods: 286 patients selected with a clinical indication to cSE, in which CFR-LAD was measured during the test who also underwent coronary angiography within 3 months were selected and diagnostic performance compared.

Results: Demographics and clinical variables were univariate predictors of LAD or LM >50% stenosis, but rDSVR < 1.7 outperformed other variables (OR 11.18, 95% CI 5.82-21.49, p < 0.001), comprising cSE variables such as reversible WM abnormalities (OR 1.53, 95% CI 0.94-2.49, p = 0.087) or CFR-LAD < 2 (OR 2.88, 95% CI 21.74-4.77, p < 0.001). The addition of rDSVR to multivariate logistic regression models (clinical or clinical + cSE variables) led to a marked increase in C-index (0.82, 95%CI 0.78-0.87) with significant improvement compared to all prior models (p < 0.001).

Conclusions: Our data suggest a strict association of reduced rDSVR with >50% coronary artery stenosis on the LM/LAD, superior to other standard clinical or cSE related indexes, such as WM assessment or CFR-LAD, and builds incrementally to them and clinical variables in multivariable logistic models for the prediction of CAD on LM and LAD coronaries.
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http://dx.doi.org/10.1016/j.ijcard.2019.01.104DOI Listing
April 2019

Rare diseases under different levels of economic analysis: current activities, challenges and perspectives.

RMD Open 2018 12;4(Suppl 1):e000794. Epub 2018 Nov 12.

Institute of Management, Scuola Superiore Sant'Anna, Pisa, Italy.

Rare diseases imply clinical and economic burden as well as a significant challenge for health systems. One relevant objective of the activities planned within the European Reference Network on Rare and Complex Connective Tissue and Musculoskeletal Diseases (ERN ReCONNET) is to address the economic dimensions of rare diseases to identify, develop and suggest strategies to improve research and patients' access to orphan drugs (ODs) and highly specialised health technologies. This paper presents a preliminary review of the existing policies on rare diseases in the countries of the Network members. It also introduces and discusses the theme of of rare diseases and of existing or new treatments for rare diseases. To obtain a preliminary overview aiming at defining the state of the art of rare diseases policies and initiatives in ERN ReCONNET countries, we collected and analysed the rare diseases national plans of all the eight countries of the ERN ReCONNET participants. The preliminary overview that has been performed showed that in all the ERN ReCONNET countries are in place national plans for rare diseases; however, heterogeneity exists in the reimbursement of ODs, direct provision by the healthcare system, involvement of patients' associations in decision making and implementation of clinical practice guidelines.
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http://dx.doi.org/10.1136/rmdopen-2018-000794DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6241967PMC
November 2018

Structured cost analysis of robotic TME resection for rectal cancer: a comparison between the da Vinci Si and Xi in a single surgeon's experience.

Surg Endosc 2019 06 24;33(6):1858-1869. Epub 2018 Sep 24.

Institute for Medical Science and Technology, University of Dundee, Dundee, Scotland, UK.

Background: Robotic-assisted surgery by the da Vinci Si appears to benefit rectal cancer surgery in selected patients, but still has some limitations, one of which is its high costs. Preliminary studies have indicated that the use of the new da Vinci Xi provides some added advantages, but their impact on cost is unknown. The aim of the present study is to compare surgical outcomes and costs of rectal cancer resection by the two platforms, in a single surgeon's experience.

Methods: From April 2010 to April 2017, 90 robotic rectal resections were performed, with either the da Vinci Si (Si-RobTME) or the da Vinci Xi (Xi-RobTME). Based on CUSUM analysis, two comparable groups of 40 consecutive Si-RobTME and 40 consecutive Xi-RobTME were obtained from the prospectively collected database and used for the present retrospective comparative study. Data costs were analysed based on the level of experience on the proficiency-gain curve (p-g curve) by the surgeon with each platform.

Results: In both groups, two homogeneous phases of the p-g curve were identified: Si1 and Xi1: cases 1-19, Si2 and Xi2: cases 20-40. A significantly higher number of full RAS operations were achieved in the Xi-RobTME group (p < 0.001). A statistically significant reduction in operating time (OT) during Si2 and Xi2 phase was observed (p < 0.001), accompanied by reduced overall variable costs (OVC), personnel costs (PC) and consumable costs (CC) (p < 0.001). All costs were lower in the Xi2 phase compared to Si2 phase: OT 265 versus 290 min (p = 0.052); OVC 7983 versus 10231.9 (p = 0.009); PC 1151.6 versus 1260.2 (p = 0.052), CC 3464.4 versus 3869.7 (p < 0.001).

Conclusions: Our experience confirms a significant reduction of costs with increasing surgeon's experience with both platforms. However, the economic gain was higher with the Xi with shorter OT, reduced PC and CC, in addition to a significantly larger number of cases performed by the fully robotic approach.
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http://dx.doi.org/10.1007/s00464-018-6465-9DOI Listing
June 2019
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