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Gasparini M.,Humanitas Research Hospital IRCCS | Klersy C.,Biometry and Clinical Epidemiology | Leclercq C.,University Hospital Rennes | Lunati M.,Niguarda Ca Granda Hospital | And 6 more authors.
European Journal of Heart Failure | Year: 2015

Aims Mortality after cardiac resynchronization therapy (CRT) is difficult to predict. We sought to design and validate a simple prognostic score for patients implanted with CRT, based on readily available clinical variables, including age, gender, left ventricular ejection fraction (LVEF), New York Heart Association (NYHA) class, presence/absence of atrial fibrillation, presence/absence of atrioventricular junction ablation, coronary heart disease, diabetes, and implantation of a CRT device with defibrillation. Methods For predictive modelling, 5153 consecutive patients enrolled in 72 European centres (79% male; LVEF 25.9 ± 6.85%; NYHA class III-IV 77.5%; QRS 158.4 ± 32.3 ms) were randomly split into derivation (70%) and validation (30%) samples. The primary endpoint was total mortality and the secondary endpoint was cardiovascular mortality. The final predictive model fit was assessed by plotting observed vs. predicted survival. Results In the entire cohort, 1004 deaths occurred over a follow-up of 14 409 person years. Total mortality ranged from 3.1% to 28.2% at 2 years in the first and fifth quintile of the risk score, respectively. At 5 years, total mortality was 10.3%, 18.6%, 27.6%, 36.1%, and 58.8%, from the first to the fifth quintile. Compared with the lowest quintile (Q), total mortality was significantly higher in the other four quintiles [Q2 hazard ratio (HR) = 1.71; Q3 HR = 2.20; Q4 HR = 4.03; Q5 HR = 8.03; all P < 0.001). The final model, which was based on the entire cohort using the above variables, showed a good discrimination (Harrell's c = 0.70) and high explained variation (0.26). The mean predicted survival fitted well with the observed survival for up to 6 years of follow-up. Conclusions The VALID-CRT risk score, which is based on routine, readily available clinical variables, reliably predicted the long-term total and cardiovascular mortality in patients undergoing CRT. While this score cannot be used to predict the benefit of CRT, it may be useful for predicting survival after CRT. This may have useful implications for follow-up. © 2015 The Authors. European Journal of Heart Failure European Society of Cardiology.


PubMed | San Filippo Neri Hospital, Aston University, Fondazione Cardiocentro Ticino, Fondazione Policlinico S. Matteo IRCCS and 6 more.
Type: Journal Article | Journal: European journal of heart failure | Year: 2015

Mortality after cardiac resynchronization therapy (CRT) is difficult to predict. We sought to design and validate a simple prognostic score for patients implanted with CRT, based on readily available clinical variables, including age, gender, left ventricular ejection fraction (LVEF), New York Heart Association (NYHA) class, presence/absence of atrial fibrillation, presence/absence of atrioventricular junction ablation, coronary heart disease, diabetes, and implantation of a CRT device with defibrillation.For predictive modelling, 5153 consecutive patients enrolled in 72 European centres (79% male; LVEF 25.9 6.85%; NYHA class III-IV 77.5%; QRS 158.4 32.3 ms) were randomly split into derivation (70%) and validation (30%) samples. The primary endpoint was total mortality and the secondary endpoint was cardiovascular mortality. The final predictive model fit was assessed by plotting observed vs. predicted survival.In the entire cohort, 1004 deaths occurred over a follow-up of 14 409 person years. Total mortality ranged from 3.1% to 28.2% at 2 years in the first and fifth quintile of the risk score, respectively. At 5 years, total mortality was 10.3%, 18.6%, 27.6%, 36.1%, and 58.8%, from the first to the fifth quintile. Compared with the lowest quintile (Q), total mortality was significantly higher in the other four quintiles [Q2 hazard ratio (HR) = 1.71; Q3 HR = 2.20; Q4 HR = 4.03; Q5 HR = 8.03; all P < 0.001). The final model, which was based on the entire cohort using the above variables, showed a good discrimination (Harrells c = 0.70) and high explained variation (0.26). The mean predicted survival fitted well with the observed survival for up to 6 years of follow-up.The VALID-CRT risk score, which is based on routine, readily available clinical variables, reliably predicted the long-term total and cardiovascular mortality in patients undergoing CRT. While this score cannot be used to predict the benefit of CRT, it may be useful for predicting survival after CRT. This may have useful implications for follow-up.


Gasparini M.,Humanitas Research Hospital IRCCS | Leclercq C.,University Hospital Rennes | Yu C.-M.,Chinese University of Hong Kong | Auricchio A.,Fondazione Cardiocentro Ticino | And 4 more authors.
American Heart Journal | Year: 2014

Background In the major trials of cardiac resynchronization therapy (CRT), the survival benefit of the therapy, relative to control subjects, increases with QRS duration. In the non-CRT heart failure population, however, a wide QRS duration is associated with a shorter survival. Relative survival benefit from a therapy, however, is not synonymous with a longer absolute survival. We sought to determine whether baseline QRS duration relates to the absolute survival after CRT. Methods and Results In this prospective, longitudinal, observational study, 3,319 consecutive patients undergoing CRT (QRS 120-149 ms 26%, QRS 150-199 ms 58%, and QRS ≥200 ms 16%) were assessed in relation to mortality over 10 years. Overall mortality rates (per 100 patient-years) were 9.2%, 9.3%, and 13.3% in the 3 groups, respectively (all P <.001). Cardiac mortality rates were 6.2, 6.0, and 9.9 per 100 patient-years, respectively (all P <.001). Compared with the QRS 120-149 ms group, cardiac mortality was highest in the QRS ≥200 ms group (hazard ratio [HR] 1.72 [95% CI 1.35-2.19], P <.001), independent of age, gender, New York Heart Association class, presence of atrial fibrillation, heart failure etiology, and left ventricular ejection fraction. Median survival after CRT was longest in patients with a width of QRS 120-149 ms and shortest in patients with a QRS ≥200 ms (P <.001). In multivariable analyses, a QRS ≥200 ms emerged as a powerful independent predictor of both overall (HR 1.44 [95% CI 1.07-1.94], P =.017) and cardiac mortality (HR 1.59 [95% CI 1.14-2.24], P =.007). Conclusions At long-term follow-up, absolute overall and cardiac survival after CRT is similar in patients with a preimplant QRS duration of 120 to 149 ms and 150 to 199 ms but markedly shorter in patients with a QRS ≥200 ms. © 2014 Mosby, Inc.


Ghio S.,Cardiac | Pazzano A.S.,Cardiac | Klersy C.,Biometry and Clinical Epidemiology | Scelsi L.,Cardiac | And 4 more authors.
American Journal of Cardiology | Year: 2011

The aim of the present study was to assess the clinical and prognostic significance of right ventricular (RV) dilation and RV hypertrophy at echocardiography in patients with idiopathic pulmonary arterial hypertension. Echocardiography and right heart catheterization were performed in 72 consecutive patients with idiopathic pulmonary arterial hypertension admitted to our institution. The median follow-up period was 38 months. The patients were grouped according to the median value of RV wall thickness (6.6 mm) and the median value of the RV diameter (36.5 mm). On multivariate analysis, the mean pulmonary artery pressure (p = 0.018) was the only independent predictor of RV wall thickness, and age (p = 0.011) and moderate to severe tricuspid regurgitation (p = 0.027) were the independent predictors of RV diameter. During follow-up, 22 patients died. The death rate was greater in the patients with a RV diameter >36.5 mm than in patients with a RV diameter ≤36.5 mm: 15.9 (95% confidence interval 9.4 to 26.8) vs 6.6 (95% confidence interval 3.3 to 13.2) events per 100-person years (p = 0.0442). In contrast, the death rate was similar in patients with RV wall thickness above or below the median value. However, among the patients with a RV wall thickness >6.6 mm, a RV diameter >36 mm was not associated with a poorer prognosis (p = 0.6837). In conclusion, in patients with idiopathic pulmonary arterial hypertension, a larger RV diameter is a marker of a poor prognosis but a greater RV wall thickness reduces the risk of death associated with a dilated right ventricle. © 2011 Elsevier Inc. All rights reserved.


Gasparini M.,IRCCS Instituto Clinico Humanitas | Steinberg J.S.,St Lukes Roosevelt Hospital Center | Arshad A.,St Lukes Roosevelt Hospital Center | Regoli F.,IRCCS Instituto Clinico Humanitas | And 6 more authors.
European Heart Journal | Year: 2010

AimsTo investigate the temporal patterns, predictors, and prognostic impact of spontaneous sinus rhythm resumption (SRR) of heart failure (HF) patients with permanent atrial fibrillation (AF) treated with cardiac resynchronization therapy (CRT).Methods and resultsThis multicentre, retrospective, longitudinal study analysed 330 consecutive HF patients with permanent AF treated with a CRT device (mean age 70 ± 9 years, male 83, ischaemic aetiology 44, NYHA class III-IV 93, mean QRS duration 167 ± 40 ms, and mean ejection fraction 26 ± 7). Clinical, echocardiographic, and outcome data were collected during follow-up. Thirty-four patients experienced SRR after CRT (10.3) at a median 4-month follow-up. The strongest independent predictors were end-diastolic diameter (EDD) [hazard ratios (HR) 4.03, 95 confidence intervals (95 CI) 1.43-11.36, P = 0.008], post-CRT QRS ≤150 ms (HR 2.63, 95 CI 1.02-6.67, P = 0.05), left atrium (LA) diameter ≤50 mm (HR 4.76, 95 CI 1.72-11.82, P = 0.002), and atrioventricular junction (AVJ) ablation (HR 4.27, 95 CI 1.54-11.84, P = 0.02). The coexistence of three predictors vs. zero to two predictors increased by 3.5-fold the likelihood of SRR; while the presence of all four factors improves the probability by a factor of 5.7-fold. Sinus rhythm resumption was associated with a significantly better long-term survival (log rank P = 0.03).ConclusionOne in every 10 HF patients with permanent AF may experience SRR after CRT. Baseline EDD ≤65 mm, CRT-paced QRS ≤150 ms, LA ≤50 mm, and AVJ ablation appear to be predictive of this phenomenon. © 2010 The Author.


Meris A.,Fondazione Cardiocentro Ticino | Faletra F.,Fondazione Cardiocentro Ticino | Conca C.,Fondazione Cardiocentro Ticino | Klersy C.,Biometry and Clinical Epidemiology | And 7 more authors.
Journal of the American Society of Echocardiography | Year: 2010

Background: The aim of this study was to evaluate the timing and magnitude of global and regional right ventricular (RV) function by means of speckle tracking-derived strain in normal subjects and patients with RV dysfunction. Methods: Peak longitudinal systolic strain (PLSS) and time to PLSS in 6 RV segments (the basal, mid, and apical segments of the RV free wall and septum) were obtained in 100 healthy volunteers and 76 patients with RV dysfunction by tracking speckles inside the myocardium using grayscale images. Global PLSS and time to PLSS were based on the average of the 6 regional values. Results: There was a significant and close correlation between RV contractility as measured by PLSS and tricuspid annular plane systolic excursion (r = -0.83, P < .001). In normal subjects, PLSS was significantly greater in the free wall than in the septum (-28.7 ± 4.1% vs -19.8 ± 3.4%, P < .001), whereas time to PLSS was similar in the different regions of the right ventricle. In patients with RV dysfunction, global and regional PLSS was significantly less than in normal subjects (-13.7 ± 3.6% vs -24.2 ± 2.9%, P < .001), and a global PLSS cutoff value of -19% was helpful in distinguishing the two groups. Furthermore, time to PLSS in all of the RV septal segments and dispersion in RV contraction timing were significantly longer. Global PLSS in the patients with RV dysfunction was also significantly less in the presence of moderate to severe pulmonary hypertension (-12.7 ± 3.6% vs -14.4 ± 3.4%, P = .038). Conclusions: Speckle tracking not only makes it possible to quantify global RV function but also illustrates the physiology of RV contraction and the pattern of activation at regional level. Speckle tracking-derived strain could become an important new means of assessing and following up patients with impaired RV function and increased pulmonary pressure. Copyright 2010 by the American Society of Echocardiography.


Biagi F.,University of Pavia | Balduzzi D.,University of Pavia | Delvino P.,University of Piemonte Orientale | Schiepatti A.,University of Pavia | And 2 more authors.
European Journal of Clinical Microbiology and Infectious Diseases | Year: 2015

Whipple's disease (WD) is a rare systemic infection due, in genetically susceptible individuals, to Tropheryma whipplei, a heterogeneous Gram-positive actinobacteria. Although it has already been recognised that WD affects mainly middle-aged Caucasian men, the prevalence of WD is virtually unknown. The annual incidence of WD in the general population is said to be less than 1 per 1,000,000, but scientific evidence for these figures is still lacking. On the basis of the number of patients recorded with a diagnosis of Whipple’s disease in the regional registers for rare diseases of Lombardia, Liguria and Piemonte-Valle d'Aosta regions, we studied the prevalence of WD in the north-western part of Italy. Forty-six patients with Whipple’s disease were recorded in these regions (13 females; mean age at diagnosis 52.1 ± 11.1 years). Since 16,130,725 inhabitants live in these four regions, prevalence of WD in the general population is 3/106 and almost 30 % of the patients are females. WD is certainly a rare disease but it also affects women in a considerable proportion of cases. © 2015, Springer-Verlag Berlin Heidelberg.


Auricchio A.,Fondazione Cardiocentro Ticino | Schillinger W.,University of Gottingen | Meyer S.,University of Hamburg | Maisano F.,San Raffaele Hospital | And 8 more authors.
Journal of the American College of Cardiology | Year: 2011

Objectives: This study evaluated the safety, efficacy, and effect of MitraClip treatment on symptoms and left ventricular (LV) remodeling in nonresponders to cardiac resynchronization therapy (CRT). Background: Moderate to severe functional mitral regurgitation (FMR) frequently persists after CRT, contributing to reduced or no response to CRT. Percutaneous repair with the MitraClip has been proposed as an additional therapeutic option in select patients with significant FMR. Methods: Fifty-one severely symptomatic CRT nonresponders with significant FMR (grade <2, 100%) underwent MitraClip treatment. Changes in New York Heart Association functional class, degree of FMR, LV ejection fraction (EF), and LV end-diastolic/end-systolic volumes (EDV/ESV) before and after (3, 6, and 12 months) MitraClip implantation were recorded. Mortality data, including cause of death, were collected. Results: MC treatment was feasible in all patients (49% 1 clip, 46% 2 clips). There were 2 periprocedural deaths. Median follow-up was 14 months (25th to 75th percentile: 8 to 17 months). New York Heart Association functional class improved acutely at discharge (73%) and continued to improve progressively during follow-up (regression model, p < 0.001). The proportion of patients with significant residual FMR (grade <2) progressively decreased during follow-up (regression model, p < 0.001). Reverse LV remodeling and improved LVEF were detected at 6 months, with further improvement at 12 months (regression model, p = 0.001, p = 0.008, and p = 0.031 for ESV, EDV, and LVEF, respectively). Overall 30-day mortality was 4.2%. Overall mortality during follow-up was 19.9 per 100 person-years (95% confidence interval: 10.3 to 38.3). Nonsurvivors had more compromised clinical baseline conditions, longer QRS duration, and a more dilated heart. Conclusions: FMR treatment with the MitraClip in CRT nonresponders was feasible, safe, and demonstrated improved functional class, increased LVEF, and reduced ventricular volumes in about 70% of these study patients. © 2011 American College of Cardiology Foundation.


Ghio S.,Fondazione IRCCS Policlinico S. Matteo | Klersy C.,Biometry and Clinical Epidemiology | Magrini G.,Fondazione IRCCS Policlinico S. Matteo | D'Armini A.M.,Fondazione IRCCS Policlinico S. Matteo | And 6 more authors.
International Journal of Cardiology | Year: 2010

Background: In patients with idiopathic pulmonary hypertension (IPAH) progression of the disease and survival are related to the capability of the right ventricle to adapt to the chronically elevated pulmonary artery pressure. Although several echocardiographic variables have been associated with outcome in previous studies, a comparative evaluation of all right ventricular (RV) function indices obtainable at echocardiography has never been performed. Methods: 59 patients consecutively admitted in a tertiary referral centre because of IPAH (22 males, mean age 46.3±16.1 years, 68% in WHO class III/IV at referral) underwent right heart catheterization and echocardiography. During a median follow-up period of 52 months, 21 patients died and 2 underwent lung transplantation in emergency conditions. Results: The following parameters were associated with survival: tricuspid annular plane systolic excursion (TAPSE), RV fractional area change, degree of tricuspid regurgitation, inferior vena cava collapsibility, superior vena cava flow velocity pattern, left ventricular diastolic eccentricity index. Patients with TAPSE≤15 mm and left ventricular eccentricity index ≥1.7 had the highest event rate (51.7 per 100 person year); patients with TAPSE>15 mm and mild or no tricuspid regurgitation had the lowest event rate (2.6 per 100 person year). Conclusions: A comprehensive echocardiographic assessment of RV systolic and diastolic function based on TAPSE, left ventricular diastolic eccentricity index and degree of tricuspid regurgitation allows an accurate prognostic stratification of patients with IPAH. © 2009 Elsevier Ireland Ltd. All rights reserved.


PubMed | Anesthesiology and Intensive Care Unit, University of Pavia and Biometry and Clinical Epidemiology
Type: Journal Article | Journal: Journal of minimal access surgery | Year: 2016

The systemic impact of intra-abdominal pressure (IAP) and/or changes in carbon dioxide (CO2) during laparoscopy are not yet well defined. Changes in brain oxygenation have been reported as a possible cause of cerebral hypotension and perfusion. The side effects of anaesthesia could also be involved in these changes, especially in children. To date, no data have been reported on brain oxygenation during routine laparoscopy in paediatric patients.Brain and peripheral oxygenation were investigated in 10 children (8 male, 2 female) who underwent elective minimally invasive surgery for inguinal hernia repair. Intraoperative transcranial near-infrared spectroscopy to assess regional cerebral oxygen saturation (rScO2), peripheral oxygen saturation using pulse oximetry and heart rate (HR) were monitored at five surgical intervals: Induction of anaesthesia (baseline T1); before CO2insufflation induced pneumoperitoneum (PP) (T2); CO2PP insufflation (T3); cessation of CO2PP (T4); before extubation (T5).rScO2decreases were recorded immediately after T1 and became significant after insufflation (P = 0.006; rScO2decreased 3.6 0.38%); restoration of rScO2was achieved after PP cessation (P = 0.007). The changes in rScO2were primarily due to IAP increases (P = 0.06). The HR changes were correlated to PP pressure (P < 0.001) and CO2flow rate (P = 0.001). No significant peripheral effects were noted.The increase in IAP is a critical determinant in cerebral oxygenation stability during laparoscopic procedures. However, the impact of anaesthesia on adaptive changes should not be underestimated. Close monitoring and close collaboration between the members of the multidisciplinary paediatric team are essential to guarantee the patients safety during minimally invasive surgical procedures.

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