Publications by authors named "Luisa Zanolla"

49 Publications

A Preliminary Case-Control Study: Peritoneal Approach in Congestive Heart Failure Treatment.

Blood Purif 2021 Nov 2:1-7. Epub 2021 Nov 2.

Department of Nephrology and Dialysis, Vito Fazzi Hospital, Lecce, Italy.

Background: Congestive heart failure (CHF) associated with worsening renal function is a very common disorder, and, as well known, the goal of the treatment is reducing venous congestion and maintaining a targeted extracellular volume. The objective of the study is to evaluate regular peritoneal ultrafiltration treatment compared to a standard conservative approach in NYHA III-IV CHF patients. In particular, the primary endpoints of the study were the major event-free survival and the total days of medical care per month (which consist of the days of hospitalization and the number of outpatient visits).

Material And Methods: This is a retrospective case-control study. Twenty-four patients were included in the present study. Twelve consecutive patients were treated with peritoneal treatment (group A) and 12 matched for age, gender, and severity of disease with a standard approach. Patients were observed over a maximum period of 18 months. Information on events, hospitalizations, and number of visits was collected during follow-up.

Results: During the follow-up, we observed a major event in 4 patients in group A (33.3%) and in 8 patients in group B (66.7%). In group B, we observed 7 deaths and 1 ICD shock, while in group A, 3 deaths and 1 ICD shock. The number of visits per month was significantly lower in patients treated with the peritoneal method (1.2 [0.4-4.1] vs. 2.5 [2.0-3.1]; p = 0.03). The total days of medical care was significantly lower in group A (2.0 [1.1-5.5] vs. 4.4 [3.0-8.7]; p = 0.034). A multiple event analysis according to the Andersen-Gill model showed a significant event-free survival for group A. During the follow-up, we did not observe any episode of peritonitis in the treated group.

Conclusions: Our study shows that the peritoneal technique is a good therapeutic tool in well-selected patients with CHF. In accordance with prior experience, this intervention has not only an important and significant clinical impact but also potential economic and social consequences.
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http://dx.doi.org/10.1159/000518347DOI Listing
November 2021

Prognostic impact of antiplatelet therapy in Takotsubo syndrome: a systematic review and meta-analysis of the literature.

Heart Fail Rev 2021 Mar 29. Epub 2021 Mar 29.

Division of Cardiology, Department of Medicine, University of Verona, Verona, Italy.

While the most recent evidence suggests a lack of benefit, antithrombotic therapy is still extensively prescribed in patients with Takotsubo syndrome (TTS). The objective of this study was to determine whether patients with TTS benefit from anti-aggregation, in terms of either short-term or long-term outcomes. A systematic review and meta-analysis was conducted. A comprehensive search of the literature included MEDLINE, Cochrane Library, Clinicaltrials.gov, EU Clinical Trial Register, References, and contact with the authors. Methodological quality assessment and data extraction were systematically performed. The review adhered to the PRISMA framework guidelines. A total of 86 citations were identified, six being eligible for inclusion, for a total of 1997 patients. One of them considered both short-term and long-term outcomes. One reported outcomes during the index event, while the remaining four focused on potential long-term benefits. They were all retrospective cohort studies.Based on our data, the long-term use of antiplatelet therapy (AT) led to a significantly higher incidence of the composite outcome (OR: 1.54; 95% CI 1.09-2.17; p = 0.014) and overall mortality (OR 1.72; 95% CI 1.07-2.77; p = 0.027). The analysis did not show a statistically significant difference in TTS recurrences, stroke/TIA, and MI or CAD worsening with AT compared with no anti-aggregation. The AT in this settings did not show any clear benefit in improving the long-term outcomes, and it may be even detrimental and it may be detrimental. These results warrant further future research and the design of adequately powered randomized controlled trials focusing on the impact of aspirin on the outcomes in patients presenting with TTS.
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http://dx.doi.org/10.1007/s10741-021-10099-5DOI Listing
March 2021

Occurrence, outcomes and predictors of portal hypertension in cystic fibrosis: A longitudinal prospective birth cohort study.

J Cyst Fibros 2020 05 31;19(3):455-459. Epub 2019 Oct 31.

Department of Gastroenterology/James Fairfax Institute of Paediatric Nutrition, The Children's Hospital at Westmead, Sydney, Australia. Electronic address:

Background: The reported prevalence of portal hypertension (PH) in Cystic Fibrosis is variable, incidence rates rarely provided and the utility of liver function tests (LFT's) early in life to predict PH is questionable. The aims were to (1) determine PH prevalence (P) and incidence rate (IR) and combined mortality transplant (MTX) data in PH vs non-PH patients and (2) to assess association of LFTs in early life with liver disease and PH.

Method: (1) A double centre longitudinal cohort study of 577 CF patients diagnosed by newborn screening (NBS) with annual examinations for PH up to 18.5 years of age (max) was performed over 28 years for P, IR, and MTX data; (2) Cox proportional hazard models were used to assess the association of elevated LFTs on 2 or more occasions over 0-6.5 years and PH.

Results: 51/577(8.8%) developed PH with an average IR of near 3/1000 patient years per 5 year interval representing young, mid and late childhood respectively in patients 3-18 years of age. Combined mortality/liver transplant occurred in 12/51 (23.5%) PH and 25/526 (4.8%) non-PH (p < 0.001). Elevated enzymes particularly GGT (HR:5.71, 95% CI 3.11-10.47); ALT/GGT (HR: 5.56, 95% CI 2.82-10.98); and ALP/GGT (HR: 5.74, 95% CI 2.78-11.86) were associated with the onset of PH.

Conclusion: This birth cohort with annual examination for PH provides an accurate assessment of the prevalence, and IR of PH and MTX of PH vs non-PH. Early elevated LFTs are associated with onset of MBC/PH.
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http://dx.doi.org/10.1016/j.jcf.2019.09.016DOI Listing
May 2020

Sacubitril/valsartan eligibility and outcomes in the ESC-EORP-HFA Heart Failure Long-Term Registry: bridging between European Medicines Agency/Food and Drug Administration label, the PARADIGM-HF trial, ESC guidelines, and real world.

Eur J Heart Fail 2019 11 18;21(11):1383-1397. Epub 2019 Jun 18.

Division of Cardiology, Department of Medicine, Karolinska Institutet, Stockholm, Sweden; Heart and Vascular Theme, Karolinska University Hospital, Stockholm, Sweden.

Aims: To assess the proportion of patients with heart failure and reduced ejection fraction (HFrEF) who are eligible for sacubitril/valsartan (LCZ696) based on the European Medicines Agency/Food and Drug Administration (EMA/FDA) label, the PARADIGM-HF trial and the 2016 ESC guidelines, and the association between eligibility and outcomes.

Methods And Results: Outpatients with HFrEF in the ESC-EORP-HFA Long-Term Heart Failure (HF-LT) Registry between March 2011 and November 2013 were considered. Criteria for LCZ696 based on EMA/FDA label, PARADIGM-HF and ESC guidelines were applied. Of 5443 patients, 2197 and 2373 had complete information for trial and guideline eligibility assessment, and 84%, 12% and 12% met EMA/FDA label, PARADIGM-HF and guideline criteria, respectively. Absent PARADIGM-HF criteria were low natriuretic peptides (21%), hyperkalemia (4%), hypotension (7%) and sub-optimal pharmacotherapy (74%); absent Guidelines criteria were LVEF>35% (23%), insufficient NP levels (30%) and sub-optimal pharmacotherapy (82%); absent label criteria were absence of symptoms (New York Heart Association class I). When a daily requirement of ACEi/ARB ≥ 10 mg enalapril (instead of ≥ 20 mg) was used, eligibility rose from 12% to 28% based on both PARADIGM-HF and guidelines. One-year heart failure hospitalization was higher (12% and 17% vs. 12%) and all-cause mortality lower (5.3% and 6.5% vs. 7.7%) in registry eligible patients compared to the enalapril arm of PARADIGM-HF.

Conclusions: Among outpatients with HFrEF in the ESC-EORP-HFA HF-LT Registry, 84% met label criteria, while only 12% and 28% met PARADIGM-HF and guideline criteria for LCZ696 if requiring ≥ 20 mg and ≥ 10 mg enalapril, respectively. Registry patients eligible for LCZ696 had greater heart failure hospitalization but lower mortality rates than the PARADIGM-HF enalapril group.
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http://dx.doi.org/10.1002/ejhf.1532DOI Listing
November 2019

Role of Speckle Tracking Echocardiography in the Evaluation of Breast Cancer Patients Undergoing Chemotherapy: Review and Meta-analysis of the Literature.

Cardiovasc Toxicol 2019 12;19(6):485-492

Division of Cardiology, Department of Medicine, University of Verona, P.le Stefani 1, 37126, Verona, Italy.

Diagnosis and management of Cancer therapeutics-related cardiac dysfunction is of crucial importance in breast cancer (BC) patients. The role of advanced echocardiographic techniques, such as deformation imaging, in the diagnosis and characterization of patients receiving cancer therapy has so far involved relatively small studies in the research setting. Therefore, we conducted a meta-analysis and systematic review of observational studies evaluating myocardial changes during chemotherapy detected through conventional echocardiographic parameters, such as 2D left ventricular ejection fraction (2D LVEF), and 2D Speckle tracking echocardiography (STE). The literature search retrieved 487 research works, articles, of which 17 were found to be pertinent with this topic. After full article review, 16 studies were considered suitable for the present analysis. Two separate analyses, one for the anthracyclines-based therapeutic regimen and one for the trastuzumab based therapeutic regimen, were performed. A significant reduction in 2D LVEF and 2D STE parameters during cancer therapy was found in both the investigations. Peak systolic global longitudinal strain demonstrated to be the most consistent 2D STE parameter in detecting early myocardial changes among all the studies. Thus, we confirmed the role of 2D STE for the early detection of myocardial damage, suggesting its crucial role in monitoring BC patients and eventually driving the introduction of cardioprotective treatment.
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http://dx.doi.org/10.1007/s12012-019-09523-yDOI Listing
December 2019

Exercise Training on Locomotion in Patients with Alzheimer's Disease: A Feasibility Study.

J Alzheimers Dis 2018 ;61(4):1599-1609

Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.

Background: Although current literature has shown that patients with Alzheimer's disease (AD) have worse locomotion compared with healthy counterparts, no studies have focused on the efficacy of exercise training in improving gait abnormalities including biomechanics and metabolic aspects, in this population.

Objective: To verify the effectiveness of exercise training (ET) on gait parameters (i.e., speed, step and stride length, single and double support, and energy cost of walking (Cw)) in patients with AD with respect to a standard cognitive treatment (CT).

Methods: In this study, we included a small portion of data belonging to a larger study (ClinicalTrials.gov number, NCT03034746). Patients with AD (Mini-Mental State Examination 22±5) were included in the study. Gait parameters and Cw were assessed at baseline and after 6 months (72 treatment sessions) of treatment. ET included 90 min of aerobic and strength training. CT included 90 min of cognitive stimuli.

Results: The 16 patients assigned to ET exhibited significant improvement of Cw (-0.9±0.1 J/kg·m-1), while differences in gait parameters were negligible. The effect on gait parameters were undetectable in the 18 patients assigned to CT (-0.2±0.5 J/kg·m-1).

Conclusions: Data from this study showed that ET program seems effective in improving Cw in patients with AD. Interestingly, the positive effect of ET on Cw was not coupled with ameliorations of patient's gait parameters, suggesting that the gain of metabolic aspects of locomotion were the main factors responsible for this positive result.
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http://dx.doi.org/10.3233/JAD-170625DOI Listing
January 2019

Association between Beta1 -Adrenergic Receptor Polymorphism and Risk of ICD Shock in Heart Failure Patients.

Pacing Clin Electrophysiol 2016 Jun 4;39(6):557-64. Epub 2016 May 4.

Department Medical Sciences, University of Torino, Torino, Italy.

Background: Sympathetic activation in heart failure patients favors the development of ventricular arrhythmias, thus leading to an increased risk of sudden cardiac death. β1 - and β2 -adrenergic receptor polymorphisms have been linked to the risk of sudden death. Implantable cardioverter-defibrillators (ICD) are implanted in a large percentage of heart failure patients, and beyond preventing sudden cardiac death they provide a continuous monitoring of major ventricular arrhythmias and of their own interventions. We investigated whether functionally relevant β1 - and β2 -adrenergic receptor polymorphisms are associated with risk of ICD shocks, as evidenced in ICD memory.

Methods: 311 patients with systolic heart failure were enrolled, and number and timing of shocks in ICD memory were recorded. Four selected polymorphisms were determined: β1 -adrenergic receptor polymorphisms Ser(49) Gly and Arg(389) Gly and β2 -adrenergic receptor polymorphisms Arg(16) Gly and Gln(27) Glu.

Results: Only Ser(49) Gly was significantly correlated with time free from ICD shocks, both considering time to the first event in a Cox model (hazard ratio 2.117), and modeling repeated events with the Andersen-Gill method (hazard ratio 2.088). Gly allele carriers had a higher probability of ICD shock. The relationship remained significant even after adjusting for ejection fraction and beta-blocker dosage (hazard ratio 1.910).

Conclusions: Data from our study suggest that the β adrenoreceptor Gly 49 allele of the β1 -adrenergic receptor Ser(49) Gly polymorphisms may increase the risk of ICD shock in patients with heart failure, independent of beta-blocker dosage.
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http://dx.doi.org/10.1111/pace.12860DOI Listing
June 2016

Dynamic changes of repolarization abnormalities in takotsubo cardiomyopathy.

Acta Cardiol 2015 Apr;70(2):225-32

Objective: This study analyses dynamicchangesin dispersion of ventricularrepolarization over the time course of takotsubo cardiomyopathy (TC), and their relationships with clinical features and life-threatening arrhythmias.

Methods And Results: All consecutive patients admitted to our division between January 2008 and December 2011 with a diagnosis of TC were analysed. Patients with prior myocardial infarction, symptoms-onset-to-admission time greater than 12 hours, an implanted pacemaker, or under treatment with drugs affecting QTinterval, were excluded. Standard 12-lead ECG recordings during the acute, subacute and chronic phases were collected for each patient. Twenty-four patients (23 women, 63 +/- 14 years) were includedin our analysis. Only one patient experienced ventricular arrhythmias (4.2%). Significant increases were observed in QT and QTc intervals (from 420 ?423 to 505 +/- 66 ms, P < 0.00001, and from 479 +/- 33 to 551 +/- 51 ms, P < 0.00001, respectively), QTdispersion (from 59 +/- 18 to 100 +/- 44 ms, P=0.0006), Tpeak-to-Tend (from 82 +/- 20 to 123 +/- 39 ms, P=0.00006) and Tpeak-to-Tend/QT (from 0.20 +/- 0.33 to 0.26 +/- 0.57, P=0.0003) during the subacute phase. All these parameters returned to baseline values in the chronic phase and did not show any significant differences between the acute and chronic phases.

Conclusions: A marked increase in QTc, QT dispersion, Tpeak-to-Tend and Tpeak-to-Tend/QT was observed during the subacute phase; this increase was transient and reverted in allpatients before hospital discharge. Ofnote, these findings were not associated with an increased risk of life-threatening arrhythmias.
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http://dx.doi.org/10.1080/ac.70.2.3073515DOI Listing
April 2015

Identification of high-risk chronic heart failure patients in clinical practice: role of changes in left ventricular function.

Clin Cardiol 2012 Sep 15;35(9):580-4. Epub 2012 Jun 15.

Department of Medicine, Section of Cardiology, University of Verona, Verona, Italy.

Background: Left ventricular (LV) dysfunction and remodeling are key pathophysiological features underlying disease progression in chronic heart failure (CHF).

Hypothesis: To describe the course of LV dysfunction and identify predictors and prognostic impact of changes in LV volumes and function in stable CHF patients under optimal therapy.

Methods: There were 318 consecutive CHF outpatients who underwent a repeated echocardiographic evaluation at baseline and at 1 year and subsequently followed-up for at least 12 months. The end point of the study was all-cause mortality.

Results: Mean LV ejection fraction (LVEF) was 33 ± 7% at baseline and 36 ± 9% at follow-up. Twenty-four percent of patients had an improvement of LVEF >5 absolute points (group 1); 58% remained stable (group 2), 17% worsened at >5 absolute points (group 3). Age, New York Heart Association class, diuretic dose, renal function, and baseline LVEF were independent predictors of LVEF improvement at 1 year. At the Cox analysis, patients in group 3 had a 4-fold higher risk of death when compared with group 1 (hazard ratio: 3.99, 95% confidence interval: 1.6-9.9, P = 0.002), independently of age, etiology, and symptoms severity.

Conclusions: In stable CHF outpatients, LV function improves in 24% of cases; a modest decrease in LV systolic function is associated with a significantly higher risk of all-cause mortality, independent of other markers of disease severity.
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http://dx.doi.org/10.1002/clc.22024DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6652648PMC
September 2012

Immunosuppressive therapy with oral prednisone to prevent restenosis after PCI. A multicenter randomized trial.

Am J Med 2011 May;124(5):434-43

Department of Medicine, University of Verona, Verona, Italy.

Background: Prednisone at immunosuppressive doses after stenting has shown remarkable efficacy in reducing ischemic recurrences in nondiabetic patients with high post-procedural levels of C-reactive protein; the study aim was to compare the clinical outcome obtained in a control group of patients treated with bare metal stents versus 2 other study groups--bare metal stent plus oral prednisone or drug eluting stents--assuming similar optimal adjunctive medical treatment.

Methods: Five tertiary Italian hospitals enrolled 375 nondiabetic patients with coronary artery disease and no contraindications to dual antiplatelet treatment or corticosteroid therapy in a randomized, controlled study performed between 2007 and 2009. Patients were allocated into 3 study groups: bare metal stents (controls), bare metal stents followed by a 40-day prednisone treatment, or drug-eluting stents. The primary endpoint was the event-free survival of cardiovascular death, myocardial infarction, and recurrence of ischemia needing repeated target vessel revascularization at 1 year as adjudicated by an independent clinical events committee.

Results: One-year follow-up was obtained in all patients. Patients receiving bare metal stents alone as compared to those treated with prednisone or drug-eluting stents had lower event-free survival; the primary endpoint was 80.8% in controls compared to 88.0% in the prednisone and 88.8% in the drug-eluting stent groups, respectively (P=.04 and .006).

Conclusion: Compared with bare metal stents alone, prednisone treatment after bare metal stents or drug-eluting stent implantation result in a better event-free survival at 1 year.
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http://dx.doi.org/10.1016/j.amjmed.2010.11.027DOI Listing
May 2011

Injury risk factors in young soccer players detected by a multivariate survival model.

J Sci Med Sport 2011 Jul 6;14(4):293-8. Epub 2011 Apr 6.

Department of Neurological, Neuropsychological, Morphological and Motor Sciences, University of Verona, Italy.

Soccer is a popular game practiced all around the world by teenagers. However, despite being a relatively safe sport, muscle-strain injuries during competitive matches are common compared to other team-sports. Few studies, to date, have investigated risk factors for soccer injuries using a multivariate survival model (e.g., Cox regression). The aim of this study was to use a multivariate survival model to investigate factors associated with an increased risk of thigh muscle strains, in young soccer players. A multivariate Cox regression was used to evaluate survival probability predictors for thigh muscle strains. 84 young male soccer players (16.4 ± 1.6 years) were followed for a season. Baseline tests were performed for body size, body composition, endurance, flexibility, and jump height from both a static position (SJ), and with a countermovement (CMJ); the percentage difference between the two types of jumps was also calculated (ΔJH). Cox regression result (hazard ratio; C.I. 95%) showed that: previous injuries (2.80; 1.19-6.54), ΔJH (0.79; 0.71-0.87), and stature (1.17; 1.06-1.25) were significantly correlated to thigh-strain survival probability. This study confirms that previous injuries are an important risk factor. However, we also report that a negative ΔJH and an elevated stature increased the probability of thigh strain. This could be explained by poor player coordination, influencing jumping ability, which may be even more evident in tall young players.
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http://dx.doi.org/10.1016/j.jsams.2011.02.013DOI Listing
July 2011

An interactive computer program can effectively educate potential users of cystic fibrosis carrier tests.

Am J Med Genet A 2011 Apr 17;155A(4):778-85. Epub 2011 Mar 17.

Cystic Fibrosis Center, Azienda Ospedaliera Universitaria Integrata, Verona, Italy.

The demand for cystic fibrosis (CF) carrier testing is steadily growing, not only from individuals with raised a priori carrier risk, but also from the general population. This trend will likely exceed the availability of genetic counselors, making it impossible to provide standard face-to-face genetic counseling to all those asking for the test. In order to reduce the time needed to educate individuals on the basics of the disease, its genetic transmission, and carrier testing peculiarities, we developed an educational method based on an interactive computer program (IC). To assess the effectiveness of this program and to compare it to a classical genetic counseling session, we conducted a comparative trial. In a population setting of people undergoing assisted reproduction, 44 individuals were randomly assigned to either receiving standard one-on-one genetic counseling or education by the IC program. We measured pre- and post-intervention knowledge about CF genetic transmission and carrier testing. Starting from an equivalent baseline of correct answers to a specially designed multiple-choice questionnaire (47% in the counselor group and 45% in the computer group) both groups showed a highly significant and similar increase (reaching 84% in the counselor group and 85% in the computer group). The computer program under evaluation can successfully educate individuals considering genetic testing for CF.
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http://dx.doi.org/10.1002/ajmg.a.33870DOI Listing
April 2011

Physiopathologic correlates of intrathoracic impedance in chronic heart failure patients.

Pacing Clin Electrophysiol 2011 Apr 22;34(4):407-13. Epub 2010 Nov 22.

Divisione Clinicizzata di Cardiologia, Azienda Ospedaliera Istituti Ospitalieri di Verona, Verona, Italy.

Background: Increased plasma levels of amino-terminal fraction of brain natriuretic peptide (NT-proBNP) and alterations of diastolic filling as described by Doppler transmitral flow pattern are well-known markers of decompensated heart failure (HF). Recently, some implantable defibrillators have allowed monitoring of intrathoracic impedance, which is related to lung water content, potentially indicating HF deterioration. The aim of this study was to assess the correlation between intrathoracic impedance and NT-proBNP and echo-Doppler transmitral flow indexes.

Methods: Data were collected from 111 HF patients, in six Italian centers. All patients were on optimal medical therapy. Device diagnostics, echographic data, NT-proBNP determination, and clinical status as assessed by the Heart Failure Score (HFS) were registered at baseline, at bimonthly visits, and at unscheduled examinations due to HF decompensation or device alerts.

Results: Over a median follow-up of 413 days, 955 examinations were performed. Intrathoracic impedance was significantly correlated with NT-proBNP (P = 0.013) and with mitral E-wave deceleration time (DtE) (P = 0.017), but not with HFS. At the time of confirmed alert events, NT-proBNP was significantly higher than during confirmed nonalert event examinations; DtE did not differ, whereas impedance was significantly lower.

Conclusion: A decrease in intrathoracic impedance is inversely correlated with NT-proBNP and directly correlated with DtE. Intrathoracic impedance monitoring therefore has the physiologic basis for being a useful tool to identify early HF decompensation.
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http://dx.doi.org/10.1111/j.1540-8159.2010.02979.xDOI Listing
April 2011

Cardiovascular and noncardiovascular comorbidities in patients with chronic heart failure.

J Cardiovasc Med (Hagerstown) 2011 Feb;12(2):76-84

Cardiology, Department of Experimental and Applied Medicine, University of Brescia, Brescia, Italy.

A broad spectrum of concomitant disorders may complicate heart failure adding further morbidity and mortality risk. Comorbidities may be subdivided into cardiovascular and noncardiovascular. The first group includes hypertension, coronary artery disease, peripheral artery disease, cerebrovascular disease, arrhythmias and valvular heart disease. Noncardiovascular comorbidities include respiratory, endocrine, metabolic, nutritional, renal, hematopoietic, neurological as well as musculoskeletal conditions. In recent years, advances in the treatment of heart failure have not been attended by important changes in management of its comorbidities. They now seem to be major causes of the poor prognosis of heart failure patients. In this review we provide an updated summary of the epidemiological, pathophysiological and clinical characteristics of comorbidities as well as their potential impact for heart failure treatment.
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http://dx.doi.org/10.2459/JCM.0b013e32834058d1DOI Listing
February 2011

[Nonvalvular atrial fibrillation: thromboembolic risk assessment and therapy in a general practice population].

G Ital Cardiol (Rome) 2010 Apr;11(4):313-7

Divisione Clinicizzata di Cardiologia, A.O. Istituti Ospitalieri, Verona.

Background: Cardiologists may prescribe antithrombotic therapy to patients with atrial fibrillation (AF), but prescription application mostly depends on general practitioners. The present study aims to assess frequency and appropriateness of antithrombotic therapy in general practice, as a function of thromboembolic risk factors, using the CHADS2 score.

Methods: The computer records of 39 general practitioners were evaluated in order to identify patients with non-valvular AF; therapy and thromboembolic risk factors were recorded.

Results: AF was documented in 951 patients; 96 (10.1%) had contraindications to oral anticoagulants. Among the remaining 850 patients, 292 (34.4%) did not receive antithrombotic therapy according to guidelines. In particular, 102 (12.0%) did not receive any antithrombotic treatment.

Conclusions: Among general practitioners of the Veneto region (Italy), the application of guidelines on antithrombotic therapy in non-valvular AF is comparable, or even slightly better than that reported in published cohort studies, but it deserves further improvement. There is a need for targeted educational interventions and a better coordination between cardiologists and general practitioners.
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April 2010

Sleep disordered breathing is associated with appropriate implantable cardioverter defibrillator therapy in congestive heart failure patients.

Clin Cardiol 2010 Feb;33(2):E27-30

Department of Biomedical and Surgical Sciences, University of Verona, Italy.

Background: Implantable cardioverter defibrillators (ICDs) are increasingly employed in patients affected by congestive heart failure (CHF) and sleep disordered breathing (SDB) is frequent in this population.

Hypothesis: To investigate SDB prevalence and influence on appropriate ICD discharges in CHF patients.

Methods: A total of 22 consecutive ICD patients with systolic CHF (left ventricular ejection fraction [LVEF]< 45%) were studied by polysomnography.

Results: A total of 17 (77.2%) showed SDB (apnea-hypopnea index [AHI]_ 10 events/hour). After controlling for LVEF and New York Heart Association (NYHA) class, AHI and severity of hypoxia during sleep results correlated to appropriate ICD discharges (r = 0.718; P < .001, r = - 0.619; P = .003, respectively).

Conclusions: Sleep disordered breathing is frequent in ICD recipients due to left systolic ventricular dysfunction and may increase the risk of ventricular arrhythmia and appropriate ICD discharges.
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http://dx.doi.org/10.1002/clc.20602DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6653285PMC
February 2010

Inconclusive cystic fibrosis neonatal screening results: long-term psychosocial effects on parents.

Acta Paediatr 2009 Dec 18;98(12):1927-34. Epub 2009 Aug 18.

Verona Cystic Fibrosis Centre, Ospedale Civile Maggiore, Verona, Italy.

Aim: Cystic Fibrosis (CF) Newborn Screening occasionally identifies neonates where a CF diagnosis can neither be confirmed nor excluded. To assess how parents of these infants cope with this ambiguous situation.

Methods: Parents of 11 children with Ambiguous Diagnosis (group AD) were compared with parents of 11 children diagnosed with CF through neonatal screening [group Cystic Fibrosis Diagnosis (CFD)] and with parents of 11 Healthy Control children (group HC) matched for gender and age.

Results: The emotional reaction to the inconclusive result was less pronounced in AD than in CFD (p = 0.003), and AD parents considered their infants as healthy as controls. Parents' anxiety about their child's health is stronger in CFD than in AD (p < 0.05) and HC (p < 0.001). Long-term emotional distress was rated similarly in AD and CFD, and greater than in HC (p = 0.0003). The parent/child relationship was less influenced in AD than in the CF group (p = 0.03). Seven AD and CFD parents changed their family planning projects.

Conclusion: Inconclusive neonatal screening results appear to be understood and associated with lower anxiety levels than CF diagnosis. Concern about the child's health is similar to healthy controls and lower than in parents of CF children.
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http://dx.doi.org/10.1111/j.1651-2227.2009.01485.xDOI Listing
December 2009

Usefulness of ultrasonographic markers of carotid atherosclerosis (intima-media thickness, unstable carotid plaques and severe carotid stenosis) for predicting presence and extent of coronary artery disease.

J Cardiovasc Med (Hagerstown) 2009 Dec;10(12):906-12

Department of Cardiology, University of Verona, Verona, Italy.

Objective: To investigate the usefulness of carotid ultrasound evaluation in predicting the presence and the extent of coronary artery disease in a consecutive series of patients.

Design: We examined retrospectively 1337 patients in whom both coronary angiography and carotid ultrasound were evaluated, from 1995 to 2005. Markers of carotid artery disease were considered, such as intima-media thickness more than 0.90 mm, unstable plaque and severe stenosis (> or =70%). Carotid risk score was defined as the sum of these parameters. We considered as affected by significant coronary artery disease those patients with at least one lesion more than 50% within the main branches of the coronary arteries.

Results: The markers of carotid atherosclerosis increased proportionally in patients with one-, two- or three-vessel coronary artery disease. At univariate analysis, intima-media thickness more than 0.90 mm was associated with an odds ratio of coronary artery disease of 2.28 (1.8-2.9) (P < 0.0001), unstable plaque 3.6 (2.3-5.7) (P < 0.001) and severe carotid stenosis 4.2 (2.0-8.7) (P = 0.0001). At multivariate analysis, the three markers mentioned above were independent risk factors for coronary artery disease even when considering other risk factors.

Conclusion: We confirmed the usefulness of carotid ultrasound evaluation in predicting the presence and extent of coronary artery disease. Considering the high correlation between carotid and coronary artery disease, carotid screening is useful in patients with coronary artery disease. In patients with an occasional finding of a carotid risk score of at least 2, a careful search for coronary artery disease seems warranted.
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http://dx.doi.org/10.2459/JCM.0b013e32832e62fdDOI Listing
December 2009

Periprocedural management and in-hospital outcome of patients with indication for oral anticoagulation undergoing coronary artery stenting.

J Interv Cardiol 2009 Aug 6;22(4):390-7. Epub 2009 May 6.

Cardiac Catheterization Laboratory, Division of Cardiology, Ospedale Maggiore, Bologna, Italy.

Purpose: In patients on oral anticoagulation (OAC) undergoing coronary stenting (PCI-S), procedural management and in-hospital outcome have never been specifically and prospectively investigated. Also, the contribution of early bleeding to the relevant hemorrhagic rate reported at follow-up with triple therapy of OAC, aspirin, and clopidogrel is largely unknown.

Methods: Consecutive patients with indication for OAC undergoing PCI-S at 5 centers were enrolled and prospectively evaluated.

Results: Out of 3410 patients undergoing PCI-S in the study period, indication for OAC was present in 4.8%. Femoral approach and bare metal stents were the most frequently used. During PCI-S, OAC was continued in about 30% of patients, whereas in about 20% heparin bridging was carried out. Glycoprotein IIb/IIIa inhibitors were rarely used (11%), whereas a standard bolus of unfractionated heparin was given in 93% of cases. Major adverse cardiovascular events (MACE) occurred in 4.8% of patients and major bleeding in 4.3%. No predictors of MACE or bleeding were identified, although the femoral approach was of borderline significance for major bleeding (OR 4.6, 95% CI 1.0-20.8; P = 0.05). A history of previous hemorrhage (OR 5.3, 95% CI 1.6-18.1; P = 0.007) predicted Carbofilm-coated stent implantation.

Conclusions: A limited, albeit clinically relevant, proportion of patients undergoing PCI-S has indication for OAC. Procedural management appears not substantially different from that of common patients. In-hospital major bleeding is relevant and should be taken into account when evaluating the overall hemorrhagic rate at a medium- to long-term follow-up.
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http://dx.doi.org/10.1111/j.1540-8183.2009.00468.xDOI Listing
August 2009

Comparison of midregional pro-atrial natriuretic peptide with N-terminal pro-B-type natriuretic peptide in predicting survival in patients with chronic heart failure.

J Am Coll Cardiol 2007 Nov 29;50(20):1973-80. Epub 2007 Oct 29.

Applied Cachexia Research, Department of Cardiology, Charité Medical School, Berlin, Germany.

Objectives: Our aim was assess the prognostic value of midregional pro-atrial natriuretic peptide (MR-proANP) using a new immunoassay in patients with chronic heart failure (HF).

Background: Assessment of natriuretic peptides represents a useful addition in establishing the diagnosis of chronic HF. Their plasma values are powerful predictors of survival in chronic HF.

Methods: We assessed MR-proANP in 525 chronic HF patients (derivation study: age 61 +/- 12 years, New York Heart Association (NYHA) functional class I/II/III/IV 6%/44%/41%/9%, N-terminal pro-B-type natriuretic peptide (NT-proBNP) 3,637 +/- 6,362 pg/ml) and validated our findings in 249 additional chronic HF patients (age 63 +/- 9 years, NYHA functional class I/II/III/IV 14%/50%/33%/3%, NT-proBNP 1,116 +/- 1,991 pg/ml).

Results: The MR-proANP levels (mean 339 +/- 306 pmol/l, range 24.5 to 2,280 pmol/l) increased with NYHA functional class (p < 0.0001). During follow-up (>6 months in survivors), 171 patients (33%) died. Increasing MR-proANP was a predictor of poor survival (risk ratio 1.35 per increase in standard deviation, 95% confidence interval 1.17 to 1.57; p = 0.0061), adjusted for NT-proBNP, age, left ventricular ejection fraction, NYHA functional class, creatinine, and body mass index (BMI). In receiver operating characteristic curve analysis of 12-month survival, the area under the curve for MR-proANP was 0.74 and that of NT-proBNP was 0.75 (p = 0.7). In a validation study, MR-proANP levels above the optimal prognostic cutoff value from the validation cohort remained a significant independent predictor of death. In chronic HF patients in NYHA functional class II to III and all subgroups of BMI and kidney function, MR-proANP added prognostic value to NT-proBNP. In patients with BMI > or =30 kg/m2, MR-proANP had higher prognostic power than NT-proBNP.

Conclusions: Midregional proANP is an independent predictor of mortality in patients with chronic HF. Midregional proANP adds prognostic information to NT-proBNP.
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http://dx.doi.org/10.1016/j.jacc.2007.08.012DOI Listing
November 2007

Total laparoscopic hysterectomy in cases of very large uteri: a retrospective comparative study.

J Minim Invasive Gynecol 2007 Sep-Oct;14(5):559-63

Obstetrics/Gynecology Department, Ospedale Sacro Cuore Don Calabria, Verona, Italy.

In this review, we assessed the feasibility of total laparoscopic hysterectomy (TLH) in cases of very large uteri weighting more than 500 grams. We compared surgical outcomes and short term follow-up in 149 patients with the uterus weighing less than 350 g (group A: 40-350 g) and 100 patients with the uterus weighing more than 500 g (group B: 500-1550 g). We discovered no statistical difference between the 2 groups in terms of intraoperative complications (group A: 0%; group B: 2%) and postoperative stay (group A: 3.05 +/- 1.89 days; group B: 3.2 +/- 1.28 days). There were statistically significant differences between the 2 groups in terms of operative time (group A: 101.3 +/- 34.3 min; group B: 149.1 +/- 57.2 min.; p <.0001) and postoperative hospital stay length (group A: 2.8 +/- 0.7 days; group B: 3.5 +/- 1.7 days; p <.0001). No major complications occurred in either group. Postoperative minor complications were more frequent in group B (group A: 8.7%; group B: 18%; p = .03). Median time to well-being was comparable in both groups. In conclusion, TLH is a feasible surgical technique also in cases of very large uteri. An increase in operative time, intraoperative blood loss, hospital stay length, and postoperative minor complications can be expected as the uterine weight increases.
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http://dx.doi.org/10.1016/j.jmig.2007.04.013DOI Listing
December 2007

Reducing diabetes incidence through the inhibition of the renin-angiotensin system: a strategy for reducing cardiovascular mortality and morbidity?

J Cardiovasc Med (Hagerstown) 2007 Jul;8(7):473-82

Divisione Clinicizzata di Cardiologia, Azienda Ospedaliera Istituti Ospitalieri di Verona, Verona, Italy.

The prevalence of type 2 diabetes is increasing worldwide, and prevention of the disease is a key objective. Several clinical trials reported a consistent reduction in the incidence of newly diagnosed diabetes in high-risk patients treated with renin-angiotensin system-inhibiting drugs. In all those trials, however, diabetes reduction was either a post-hoc analysis result or a secondary endpoint. Therefore, we need the results of ongoing specific prospectively designed trials, with new-onset diabetes as the principal endpoint.
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http://dx.doi.org/10.2459/01.JCM.0000278445.04613.27DOI Listing
July 2007

Nurse educational activity on non-prescription therapies in patients with chronic heart failure.

Eur J Cardiovasc Nurs 2007 Dec 18;6(4):314-20. Epub 2007 May 18.

Divisione Clinicizzata di Cardiologia - Azienda Ospedaliera Istituti Ospitalieri Verona - Piazzale Stefani 1 - 37126 Verona, Italy.

Background: Notwithstanding the polypharmacy required for heart failure therapy, many patients use non-prescription therapies, including alternative medicines, herbal remedies, integrators and over-the-counter (OTC) drugs.

Aims: Non-prescription therapies could interfere with heart failure therapy, both promoting non-compliance and through pharmacological interferences. Heart failure nurses, in order to plan their educational activity, need to known about the use of therapies other than prescription.

Methods: The use of non-prescription therapies was assessed by a structured interview in 153 chronic patients with heart failure.

Results: Only 15.7% patients exclusively used medicines prescribed by their physicians. Alternative medicine use was not frequent (5.8%), herbal remedies (21.3%) and integrators (20.9%) were more used; OTC drugs were most common, with 75.8% use. Patients were often unaware of possible interaction with heart failure therapies, and seldom informed physician of use.

Conclusions: Advice about drugs avoidance is emphasized by heart failure guidelines, and is part of the nurse educational activity. More attention should be paid to OTC drug assessment and education since their use is common.
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http://dx.doi.org/10.1016/j.ejcnurse.2007.04.001DOI Listing
December 2007

Left atrial volume provides independent and incremental information compared with exercise tolerance parameters in patients with heart failure and left ventricular systolic dysfunction.

Heart 2007 Nov 12;93(11):1420-5. Epub 2006 Dec 12.

Department of Biomedical and Surgical Sciences, Section of Cardiology, University of Verona, Italy.

Objective: Left atrial volume (LAV) is a powerful predictor of outcome in patients with chronic heart failure (CHF) independently of symptomatic status, age and left ventricular (LV) function. It is unknown whether LAV provides independent and incremental information compared with exercise tolerance parameters.

Methods: 273 patients with CHF (mean (SD) 62 (9) years; 13% female) prospectively underwent echocardiography and exercise testing with maximal oxygen consumption (Vo(2)). The primary end point was composite and included cardiac death, hospitalisation for worsening heart failure or cardiac transplantation.

Results: At Cox proportional hazard analysis, LAV normalised for body surface area (LAV/BSA) was strongly associated with mortality (hazard ratio (HR) = 1.027 (95% CI 1.018 to 1.04), p<0.001). The predictive value of LAV/BSA was independent of Vo(2) and LV ejection fraction (EF) (HR = 1.014 (1.002 to 1.025), p = 0.02; HR = 0.95 (0.91 to 0.99), p = 0.02; HR = 0.89 (0.82 to 0.98), p = 0.02 for LAV/BSA, EF and Vo(2), respectively). Receiver operator characteristic (ROC) curve analysis identified the best cut-off values for prediction of the end point. LAV/BSA >63 ml, EF <30% and Vo(2) <16 ml/kg/min were considered to be risk factors. Patients with three risk factors had an HR of 38 (95% CI 11 to 129) compared with patients with no risk factors.

Conclusion: LAV provides powerful prognostic information incrementally and independently of Vo(2). LAV, EF and Vo(2 )can be used to build a risk prediction model, which can be used clinically.
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http://dx.doi.org/10.1136/hrt.2006.101261DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2016944PMC
November 2007

Chest physiotherapy with positive airway pressure: a pilot study of short-term effects on sputum clearance in patients with cystic fibrosis and severe airway obstruction.

Respir Care 2006 Oct;51(10):1145-53

Cystic Fibrosis Center, Ospedale Civile Maggiore, Verona, Italy.

Background: The periodic administration of positive airway pressure combined with directed cough could aid mucus clearance in patients with cystic fibrosis (CF) and severe airway obstruction.

Objective: To compare the short-term effect of positive expiratory pressure (PEP) physiotherapy via mask (mask PEP), continuous positive airway pressure (CPAP), and noninvasive positive-pressure ventilation (NPPV) physiotherapies on amount of sputum collected.

Methods: Directed cough was standardized for each patient and used as the control treatment. We studied 17 patients with CF (mean +/- SD age 28 +/- 7 y) and severe airway obstruction (forced expiratory volume in the first second 25 +/- 6% of predicted) admitted for pulmonary exacerbation. Mask PEP, CPAP, NPPV, and the control treatment (directed cough) were administered in a random sequence. Each patient received each treatment twice a day (in 70-min sessions) for 2 consecutive days. We measured the wet and dry weight of sputum collected and the number of directed and spontaneous coughs during each session. Spirometry and pulse oximetry were conducted before and after each session. For mask PEP, CPAP, and NPPV, each patient gave a subjective score for the efficacy and tolerability of the treatment, compared to the control treatment.

Results: There was no statistically significant difference in the dry weight of sputum collected: mask PEP 0.9 +/- 0.6 g, CPAP 0.8 +/- 0.4 g, NPPV 0.9 +/- 0.6 g, control treatment 1.0 +/- 0.8 g. There was a statistically significant difference in the wet weight of sputum collected: mask PEP 15.8 +/- 5.5 g, CPAP 13.7 +/- 5.5 g, NPPV 13.2 +/- 5.0 g, control treatment 14.0 +/- 5.0 g (p < 0.05), but that difference became nonsignificant when we took into account the number of spontaneous coughs. There were no statistically significant changes in the spirometry and pulse-oximetry values. The patients' subjective efficacy scores were similar for mask PEP, CPAP, and NPPV. Less fatigue was reported after NPPV and CPAP than after mask PEP.

Conclusions: There were no differences in sputum clearance or pulmonary-function measures between mask PEP and short-term administration of either CPAP or NPPV combined with directed cough. After mask PEP these patients felt more tired than after CPAP or NPPV secretion-clearance therapy.
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October 2006

Right ventricular function predicts transplant-free survival in idiopathic dilated cardiomyopathy.

J Cardiovasc Med (Hagerstown) 2006 Sep;7(9):706-10

Department of Cardiology, S Bortolo Hospital, Vicenza, Italy.

Background: Right ventricular function may be reduced in patients with idiopathic dilated cardiomyopathy (IDC). The prognostic implications of right ventricular dysfunction have not been investigated in this group of patients.

Methods: In a series of 120 consecutive patients with IDC [defined as a left ventricular ejection fraction (LVEF) < 55%, normal coronary arteries and no other causes for left ventricular dysfunction], right ventricular function was prospectively evaluated by means of angiocardiography at the time of catheterization. A head-to-head comparison of ventricular volumes, ejection fraction, end-diastolic pressure, stroke work index and end-systolic pressure/volume ratio of the left and right ventricle was performed according to the Cox's proportional hazard method for the pre-defined end-point of transplant-free survival.

Results: In the study population, LVEF was 31 +/- 11% and right ventricular ejection fraction (RVEF) was 34 +/- 10%. After a mean follow-up of 30 months (range 12-120 months), 26 patients died (22%) and 14 (12%) underwent heart transplantation. At univariate analysis, all the above mentioned parameters were significantly (P < 0.0001) associated with outcome except left and right ventricular end-systolic pressure/volume ratio. At multivariate analysis, independent predictors of transplant-free survival were RVEF (P = 0.001), right ventricular stroke work index (P = 0.015), right ventricular end-diastolic volume (P = 0.034) and left ventricular end-diastolic volume (P = 0.048), but not LVEF. The same relation holds true considering the end point of total mortality.

Conclusions: Parameters of right ventricular function are strong predictors of survival in IDC, even in patients enrolled over a wide range of LVEFs. The present study suggests that right ventricular function should be evaluated in patients with IDC. A large non-invasive based study on right ventricular function in IDC appears to be warranted.
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http://dx.doi.org/10.2459/01.JCM.0000243006.90170.ceDOI Listing
September 2006

A survey of newborn screening for cystic fibrosis in Europe.

J Cyst Fibros 2007 Jan 25;6(1):57-65. Epub 2006 Jul 25.

University of Liverpool, Royal Liverpool Children's Hospital, Liverpool, United Kingdom.

Background: Cystic fibrosis (CF) is a recessively inherited condition caused by mutation of the CFTR gene. Newborn infants with CF have raised levels of immuno-reactive trypsinogen (IRT) in their serum. Measurement of IRT in the first week of life has enabled CF to be incorporated into existing newborn screening (NBS) blood spot protocols. However, IRT is not a specific test for CF and NBS therefore requires a further tier of tests to avoid unnecessary referral for diagnostic testing. Following identification of the CFTR gene, DNA analysis for common CF-associated mutations has been increasingly used as a second tier test. The aim of this study was to survey the current practice of CF NBS programmes in Europe.

Method: A questionnaire was sent to 26 regional and national CF NBS programmes in Europe.

Results: All programmes responded. The programmes varied in number of infants screened and in the protocols employed, ranging from sweat testing all infants with a raised first IRT to protocols with up to four tiers of testing. Three different assays for IRT were used; in the majority (24) this was a commercially available kit (Delfia). A number of programmes employed a second IRT measurement in the 4th week of life (as the IRT is more specific at this point). Nineteen programmes used DNA analysis for common CFTR mutations on samples with a raised first IRT. Three programmes used a second IRT measurement on infants with just one recognised mutation to reduce the number of infants referred for sweat testing. Referral to clinical services was prompt and diagnosis was confirmed by sweat testing, even in infants with two recognised mutations in most programmes. Subsequent clinical pathways were less uniform. Multivariate analysis demonstrated a relationship between the age of diagnosis and the timing of the first IRT. More sweat tests were undertaken if the first IRT was earlier and the diagnosis was later.

Conclusions: Annually these programmes screen approximately 1,600,000 newborns for CF and over 400 affected infants are recognised. The findings of this survey will guide the development of European evidence based guidelines and may help new regions or nations in the development and implementation of NBS for cystic fibrosis.
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http://dx.doi.org/10.1016/j.jcf.2006.05.008DOI Listing
January 2007

Aortic stiffness correlates with an increased extracellular matrix turnover in patients with dilated cardiomyopathy.

Am Heart J 2006 Jul;152(1):93.e1-6

Divisione Clinicizzata di Cardiologia, Dipartimento di Scienza Biomediche e Chirurgiche, Università di Verona, Verona, Italy.

Background: An increased extracellular matrix (ECM) turnover has been associated with poor survival in patients with chronic heart failure (CHF) due to dilated cardiomyopathy (DCM). However, the influence of the accelerated collagen turnover on the progressive large artery stiffening process characterizing CHF has not been clarified. This is relevant because aortic stiffening imposes an additional systolic load and impairs exercise tolerance in CHF patients. Therefore, we investigated whether the serum aminoterminal propeptide of type III collagen (PIIINP), an established marker of ECM turnover and tissue fibrosis in DCM, was associated with aortic stiffness in DCM patients.

Methods And Results: A total of 89 patients with clinical diagnosis of DCM (age 62 +/- 9 years, 80% men, mean ejection fraction 34% +/- 8%) were selected. Aortic pulse-wave velocity (PWV), a well-established marker of aortic stiffness, was measured by Doppler ultrasonography. Serum concentration of PIIINP was determined by radioimmunoassay. Mean aortic PWV was 5.7 +/- 2.3 m/s, and PIIINP was 5.0 +/- 1.3 microg/L. The variables correlated with aortic PWV were age (r = 0.33, P = .002), PIIINP (r = 0.30, P = .005), heart rate (r = 0.27, P = .02), stroke volume (r = -0.24, P = .03) and New York Heart Association class (r = 0.25, P = .02). In a multivariate analysis, age (P = .02) and PIIINP (P = .01) were independently related with aortic PWV, accounting for 27% of its variance.

Conclusions: Higher serum PIIINP levels are independently associated with a stiffer aorta in DCM patients. This suggests that abnormalities in the ECM turnover might involve the proximal elastic vasculature and could partially explain the progressive large artery stiffening process characterizing CHF.
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http://dx.doi.org/10.1016/j.ahj.2006.04.026DOI Listing
July 2006

Proposal for revision of the TNM classification system for renal cell carcinoma.

Cancer 2005 Nov;104(10):2116-23

Department of Urology, University of Verona, Verona, Italy.

Background: The current study defined an optimal tumor size breakpoint to stratify localized renal cell carcinoma (RCC) into groups with significantly different cancer-related outcomes and proposed a revision of the TNM classification system.

Methods: The authors analyzed the data from 1138 patients who had undergone partial or radical nephrectomy for localized RCC at 7 European urologic centers. The optimal pathologic size breakpoint was calculated using the martingale residuals from a Cox proportional hazards regression model.

Results: The mean follow-up time was 87 months. The scatterplot of tumor size versus expected risk of death per patient suggested that an interval of 5-6 cm was appropriate. A total of 720 (63.3%) and 418 (36.7%) patients had tumors measuring < or = 5.5-cm and tumors measuring > 5.5-cm, respectively. Significant cancer-specific survival differences between the two groups of patients were reported in the series by all the centers participating in the study. On univariate analysis, the other variables found to be associated with cancer-specific survival were the patient's age, symptomatic tumor presentation, and the Fuhrman nuclear grade. On multivariate analysis, the pathologic stage of the primary tumor defined according to the 5.5-cm breakpoint was found to be an independent predictor of cancer-specific survival, as well as age, mode of presentation, and nuclear grade. According to the multivariate analysis, the authors clustered patients into 3 groups with statistically significant outcome differences: 1) patients with < or = 5.5-cm incidentally detected RCC; 2) patients with < or = 5.5-cm symptomatic RCC; and 3) patients with > 5.5-cm RCC. This cancer-related outcome stratification was valid regardless of the patient's age.

Conclusions: The 5.5-cm breakpoint was found to be the optimal tumor size breakpoint with which to stratify patients with organ-confined RCC. The study supported the upgrade of the TNM classification system according to this breakpoint.
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http://dx.doi.org/10.1002/cncr.21465DOI Listing
November 2005
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