Publications by authors named "Massimo Santini"

227 Publications

Efficacy and Safety of a Combined Aerobic, Strength and Flexibility Exercise Training Program in Patients with Implantable Cardiac Devices.

J Cardiovasc Dev Dis 2022 Jun 6;9(6). Epub 2022 Jun 6.

Institute of Sports Medicine, Sport e Salute, 00197 Rome, Italy.

: The "FIDE Project" (Fitness Implantable DEvice) was organized by the Institute of Sports Medicine and Science and the World Society of Arrhythmias with the aim of demonstrating the usefulness of exercise training in improving functional capacity in patients with implantable cardiac devices. : Thirty sedentary patients were selected for the project (25 males and 5 females), with a mean age of 73 ± 5 years (range 44-94 years). Twenty-five were implanted with a Pacemaker (PM) and five with an Implantable Cardioverter Defibrillator (ICD). Atrial fibrillation/atrial flutter was present in ten (34%) patients, post-ischemic dilated cardiomyopathy in five (17.2%), sick sinus syndrome in six (20,7%), complete atrium-ventricular block in six (20.7%), hypertrophic cardiomyopathy in one (3.4%) and recurrent syncope in one (3.4%). The baseline assessment comprised cardiovascular examination, resting and stress ECG, cardiopulmonary exercise testing (V ̇O2peak), strength assessment of different muscle groups, and a flexibility test. The same measurements were repeated after 15-20 consecutive training sessions, over a 2-month period. The exercise prescription was set to 70-80% of HRR (Heart rate reserve) and to 50-70% of 1RM (1-repetition maximum, muscular force). The training protocol consisted of two training sessions per week performed in our institute, 90 min for each (warm-up, aerobic phase, strength phase and stretching) and one or more at home autonomously. : The cardiopulmonary testing after the training period documents a significant improvement in V ̇O2peak (15 ± 4 mL/kg/min vs. 17 ± 4; = 0.001) and in work load (87 ± 30 watts vs. 108 ± 37; = 0.001). Additionally, strength capacity significantly increased after the cardiac rehabilitation program, (quadriceps: 21 ± 18 kg vs. 29 ± 16 kg, = 0.00003). Flexibility tests show a positive trend, but without statistical significance (sit-and-reach test: -19 ± 11 cm vs. -15 ± 11.7 cm; back-scratch test: -19 ± 11.6 cm vs. -15 ± 10 cm; lateral flexibility right -44 ± 1.4 cm vs. -43 ± 9.5 cm; left -43 ± 5 vs. -45 ± 8.7 cm). : A brief period of combined aerobic, strength and flexibility exercise training (FIDE project) proved to be effective and safe in improving functional capacity in patients with cardiac implantable devices.
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http://dx.doi.org/10.3390/jcdd9060182DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9224932PMC
June 2022

"Decision tree analysis for assessing the risk of post-traumatic haemorrhage after mild traumatic brain injury in patients on oral anticoagulant therapy".

BMC Emerg Med 2022 03 24;22(1):47. Epub 2022 Mar 24.

Academy of Emergency Medicine and Care (AcEMC), Pavia, Italy.

Background: The presence of oral anticoagulant therapy (OAT) alone, regardless of patient condition, is an indication for CT imaging in patients with mild traumatic brain injury (MTBI). Currently, no specific clinical decision rules are available for OAT patients. The aim of the study was to identify which clinical risk factors easily identifiable at first ED evaluation may be associated with an increased risk of post-traumatic intracranial haemorrhage (ICH) in OAT patients who suffered an MTBI.

Methods: Three thousand fifty-four patients in OAT with MTBI from four Italian centers were retrospectively considered. A decision tree analysis using the classification and regression tree (CART) method was conducted to evaluate both the pre- and post-traumatic clinical risk factors most associated with the presence of post-traumatic ICH after MTBI and their possible role in determining the patient's risk. The decision tree analysis used all clinical risk factors identified at the first ED evaluation as input predictor variables.

Results: ICH following MTBI was present in 9.5% of patients (290/3054). The CART model created a decision tree using 5 risk factors, post-traumatic amnesia, post-traumatic transitory loss of consciousness, greater trauma dynamic, GCS less than 15, evidence of trauma above the clavicles, capable of stratifying patients into different increasing levels of ICH risk (from 2.5 to 61.4%). The absence of concussion and neurological alteration at admission appears to significantly reduce the possible presence of ICH.

Conclusions: The machine-learning-based CART model identified distinct prognostic groups of patients with distinct outcomes according to on clinical risk factors. Decision trees can be useful as guidance in patient selection and risk stratification of patients in OAT with MTBI.
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http://dx.doi.org/10.1186/s12873-022-00610-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8944105PMC
March 2022

Risk of delayed intracranial haemorrhage after an initial negative CT in patients on DOACs with mild traumatic brain injury.

Am J Emerg Med 2022 Mar 15;53:185-189. Epub 2022 Jan 15.

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

Background: Repeat head CT in patients on direct oral anticoagulant therapy (DOACs) with minor traumatic brain injury (MTBI) after an initial CT scan without injury on arrival in the Emergency Department (ED) is a common clinical practice but is not based on clear evidence.

Aim: To assess the incidence of delayed intracranial haemorrhage (ICH) in patients taking DOACs after an initial negative CT and the association of clinical and risk factors presented on patient arrival in the ED.

Methods: This retrospective multicentre observational study considered patients taking DOACs undergoing repeat CT after a first CT free of injury for the exclusion of delayed ICH after MTBI. Timing between trauma and first CT in the ED and pre- or post-trauma risk factors were analysed to assess a possible association with the risk of delayed ICH.

Results: A total of 1426 patients taking DOACs were evaluated in the ED for an MTBI. Of these, 68.3% (916/1426) underwent a repeat CT after an initial negative CT and 24 h of observation, with a rate of delayed ICH of 1.5% (14/916). Risk factors associated with the presence of a delayed ICH were post-traumatic loss of consciousness, post-traumatic amnesia and the presence of a risk factor when the patient presented to the ED within 8 h of the trauma. None of the patients with delayed ICH at 24-h repeat CT required neurosurgery or died within 30 days.

Conclusions: Delayed ICH is an uncommon event at the 24-h control CT and does not affect patient outcome. Studying the timing and characteristics of the trauma may indicate patients who may benefit from more in-depth management.
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http://dx.doi.org/10.1016/j.ajem.2022.01.018DOI Listing
March 2022

Arterial intracranial thrombosis as the first manifestation of vaccine-induced immune thrombotic thrombocytopenia (VITT): a case report.

Neurol Sci 2022 Mar 13;43(3):2085-2089. Epub 2022 Jan 13.

Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy.

Objective: We describe a severe case of vaccine-induced immune thrombotic thrombocytopenia (VITT) after the first dose of the ChAdOx1 nCoV-19 vaccine leading to massive ischemic stroke.

Methods: A 42-year-old woman developed acute left hemiparesis (NIHSS 12) 9 days after the first vaccine dose.

Results: The blood tests revealed low platelets (70 10/μL) and severe increment of D-dimer (70,745 ng/mL FEU). Brain non-contrast computed tomography and multiphasic CT angiography demonstrated a right middle cerebral artery occlusion. The patient was treated with primary thrombectomy, steroids, immunoglobulin, and fondaparinux. Despite the treatment, the neurological status deteriorated and underwent decompressive hemicraniectomy. She was transferred to the rehab's unit 52 days after the onset.

Discussion: Healthcare providers should be aware of the possibility of ischemic stroke as a manifestation of VITT. Awareness on this very rare and possibly fatal complication should be reinforced on both the vaccine recipients and general practitioners.
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http://dx.doi.org/10.1007/s10072-021-05800-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8754523PMC
March 2022

[50 years of electrophysiology and cardiac pacing].

G Ital Cardiol (Rome) 2021 May;22(5):341-351

U.O.C. Cardiologia, Ospedale G.B. Grassi, Ostia (RM).

During the last 50 years a continuous improvement was observed in the field of cardiac pacing and electrophysiology as for as both technological and clinical aspects were concerned. We moved from the first recording of the His bundle electrogram to the identification of the various mechanisms and sites of supraventricular and ventricular tachyarrhythmias, to three-dimensional mapping and ablation of different reentry circuits and eventually to pulmonary vein isolation for the treatment of atrial fibrillation. As far as cardiac pacing is concerned, we moved from single chamber to dual chamber pacing, to ventricular pacing and implantable automatic defibrillators provided by sophisticated diagnostic and therapeutic algorithms and by remote control. Recently a family of leadless devices (loop recorders, endocavitary pacemakers, subcutaneous defibrillators) have become available for diagnostic and therapeutic purposes and brought a significant benefit in the reduction and management of many device-related troubles.
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http://dx.doi.org/10.1714/3592.35742DOI Listing
May 2021

The relationship between cardiac injury, inflammation and coagulation in predicting COVID-19 outcome.

Sci Rep 2021 03 22;11(1):6515. Epub 2021 Mar 22.

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

High sensitivity troponin T (hsTnT) is a strong predictor of adverse outcome during SARS-CoV-2 infection. However, its determinants remain partially unknown. We aimed to assess the relationship between severity of inflammatory response/coagulation abnormalities and hsTnT in Coronavirus Disease 2019 (COVID-19). We then explored the relevance of these pathways in defining mortality and complications risk and the potential effects of the treatments to attenuate such risk. In this single-center, prospective, observational study we enrolled 266 consecutive patients hospitalized for SARS-CoV-2 pneumonia. Primary endpoint was in-hospital COVID-19 mortality. hsTnT, even after adjustment for confounders, was associated with mortality. D-dimer and CRP presented stronger associations with hsTnT than PaO. Changes of hsTnT, D-dimer and CRP were related; but only D-dimer was associated with mortality. Moreover, low molecular weight heparin showed attenuation of the mortality in the whole population, particularly in subjects with higher hsTnT. D-dimer possessed a strong relationship with hsTnT and mortality. Anticoagulation treatment showed greater benefits with regard to mortality. These findings suggest a major role of SARS-CoV-2 coagulopathy in hsTnT elevation and its related mortality in COVID-19. A better understanding of the mechanisms related to COVID-19 might pave the way to therapy tailoring in these high-risk individuals.
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http://dx.doi.org/10.1038/s41598-021-85646-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7985490PMC
March 2021

Predictors of post-traumatic complication of mild brain injury in anticoagulated patients: DOACs are safer than VKAs.

Intern Emerg Med 2021 Jun 1;16(4):1061-1070. Epub 2021 Jan 1.

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

Although mild traumatic brain injury (MTBI) in people on oral anticoagulant treatment (OAT) is a frequent challenge for Emergency Department (ED), strong guidelines recommendations are lacking. In the attempt to assess the safety profile of direct oral anticoagulants (DOACs) versus vitamin K antagonists (VKAs), we have recruited 473 patients with a MTBI on OAT (43.6% males; age 81.8 ± 8.7 years), admitted to the Pisa's University Hospital ED (Jan 2016-Oct 2018). All patients underwent a head CT scan with those with no sign of acute bleedings remaining under clinical observation for the ensuing 24 h. Fifty patients (10.6%, 95% CI: 8.1-13.7%) had immediate intracranial hemorrhage (ICH), with a prevalence of patient-important outcomes due to immediate ICH of 1.1% (95% CI 0.4-2.4%); 3 patients died (0.6%, 95% CI 0.2-1.8) and 2 required neurosurgical intervention. Immediate ICHs were more frequent in VKA-treated than in DOAC-treated patients (15.9 vs. 6.4%. RR 2.5. 95%CI 1.4-4.4. p < 0.05). Multivariate analysis identified that post-traumatic amnesia, evidence of trauma above clavicles, high blood glucose, high blood pressure (BP) at arrival, and low prothrombin activity were predictors of immediate ICH. The prevalence of delayed ICH was 1.0% (95%CI 0.4-2.5%) without differences between DOACs and VKAs. Despite ICH being a frequent complication of MTBI in patients on OAT, immediate and delayed patient-important outcomes are rare. DOACs have a better safety profile than VKAs. Simple clinical parameters such as blood pressure at arrival or blood glucose might provide useful predictors of immediate ICH.Trial registration number: 11924_CIPRIANO. Local ethics committee approval number 33096.
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http://dx.doi.org/10.1007/s11739-020-02576-wDOI Listing
June 2021

Role of Low-Molecular-Weight Heparin in Hospitalized Patients With Severe Acute Respiratory Syndrome Coronavirus 2 Pneumonia: A Prospective Observational Study.

Open Forum Infect Dis 2020 Dec 19;7(12):ofaa563. Epub 2020 Nov 19.

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

Background: This study was conducted to evaluate the impact of low-molecular-weight heparin (LMWH) on the outcome of patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pneumonia.

Methods: This is a prospective observational study including consecutive patients with laboratory-confirmed SARS-CoV-2 pneumonia admitted to the University Hospital of Pisa (March 4-April 30, 2020). Demographic, clinical, and outcome data were collected. The primary endpoint was 30-day mortality. The secondary endpoint was a composite of death or severe acute respiratory distress syndrome (ARDS). Low-molecular-weight heparin, hydroxychloroquine, doxycycline, macrolides, antiretrovirals, remdesivir, baricitinib, tocilizumab, and steroids were evaluated as treatment exposures of interest. First, a Cox regression analysis, in which treatments were introduced as time-dependent variables, was performed to evaluate the association of exposures and outcomes. Then, a time-dependent propensity score (PS) was calculated and a PS matching was performed for each treatment variable.

Results: Among 315 patients with SARS-CoV-2 pneumonia, 70 (22.2%) died during hospital stay. The composite endpoint was achieved by 114 (36.2%) patients. Overall, 244 (77.5%) patients received LMWH, 238 (75.5%) received hydroxychloroquine, 201 (63.8%) received proteases inhibitors, 150 (47.6%) received doxycycline, 141 (44.8%) received steroids, 42 (13.3%) received macrolides, 40 (12.7%) received baricitinib, 13 (4.1%) received tocilizumab, and 13 (4.1%) received remdesivir. At multivariate analysis, LMWH was associated with a reduced risk of 30-day mortality (hazard ratio [HR], 0.36; 95% confidence interval [CI], 0.21-0.6;  < .001) and composite endpoint (HR, 0.61; 95% CI, 0.39-0.95;  = .029). The PS-matched cohort of 55 couples confirmed the same results for both primary and secondary endpoint.

Conclusions: This study suggests that LMWH might reduce the risk of in-hospital mortality and severe ARDS in coronavirus disease 2019. Randomized controlled trials are warranted to confirm these preliminary findings.
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http://dx.doi.org/10.1093/ofid/ofaa563DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7717381PMC
December 2020

Ophthalmological emergencies and the SARS-CoV-2 outbreak.

PLoS One 2020 1;15(10):e0239796. Epub 2020 Oct 1.

Ophthalmology, Department of Surgical, Medical, Molecular Pathology and of Critical Care Medicine, University of Pisa, Pisa, Italy.

Since the end of 2019, an outbreak of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), originating in the Chinese city of Wuhan has spread rapidly worldwide causing thousands of deaths. Coronavirus disease (COVID-19) is supported by SARS-CoV-2 and represents the causative agent of a potentially fatal disease that is of great global public health concern. Italy has been the first European country recording an elevated number of infected forcing the Italian Government to call for total lockdown. The lockdown had the aim to limit the spread of infection through social distancing. The purpose of this study is to analyze how the pandemic has affected the patient's accesses to the Ophthalmological Emergency Department of a tertiary referral center in central-northern Italy, during the lockdown period. The charts of all patients that came to the Emergency Department during the lockdown period (March 10 -May 4, 2020) have been retrospectively collected and compared with those in the same period of 2019 and the period from 15 January- 9 March 2020. A significant reduction of visits during the lockdown has been observed, compared with those of pre-lockdown period (reduction of 65.4%) and with those of the same period of 2019 (reduction of 74.3%). Particularly, during the lockdown, minor and not urgency visits decreased whereas the undeferrable urgency ones increased. These pieces of evidence could be explained by the fear of patients to be infected; but also revealed patients misuse of emergency services.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0239796PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7529259PMC
October 2020

Safe chest tube placement in a patient with tension pneumothorax receiving rivaroxaban therapy for non-valvular atrial fibrillation.

Monaldi Arch Chest Dis 2020 Jun 12;90(2). Epub 2020 Jun 12.

Emergency Department; Azienda Ospedaliero-Universitaria Pisana, Pisa University Hospital, Italy.

The number of patients treated with direct oral anticoagulants is increasing worldwide. Although bleeding complications associated with direct oral anticoagulants are lower than those associated with vitamin K antagonists, the increased number of patients treated with these anticoagulants suggests that a higher absolute number of patients are at risk. Tube thoracostomy is an invasive procedure with a high risk of bleeding. To date, among direct oral anticoagulants, only dabigatran has a well-studied antidote to reverse its effects during emergency procedure or surgery. This report describes a case in which emergency placement of a tube thoracostomy, in a patient with type 2 respiratory failure due to left tension pneumothorax and receiving the anticoagulant rivaroxaban, in the pharmacokinetics phase with greater anticoagulant effect, did not result in bleeding greater than that typically encountered during such interventions. The procedure ended successfully with no acute complications.
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http://dx.doi.org/10.4081/monaldi.2020.1262DOI Listing
June 2020

Arrhythmias and sleep apnea: physiopathologic link and clinical implications.

J Interv Card Electrophysiol 2020 Apr 28;57(3):387-397. Epub 2020 Mar 28.

EP Lab, Aurelia Hospital, Rome, Italy.

Available evidence suggests a pathogenetic role of sleep breathing disorders in both atrial and ventricular arrhythmias with non-negligible clinical implications. Scientific literature has reported convincing findings on the link between sleep breathing disorders and arrhythmias. The coexistence of these conditions should be appropriately managed because OSA treatment may reduce arrhythmia recurrence. This paper provides an overview of the main physiopathologic mechanisms underlying the association between sleep apnea and arrhythmias and discusses the impact of sleep apnea on arrhythmia management in clinical practice.
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http://dx.doi.org/10.1007/s10840-020-00707-zDOI Listing
April 2020

Spontaneous bleeding of the inferior pancreatic-duodenal artery in median arcuate ligament syndrome: do not miss the diagnosis.

Oxf Med Case Reports 2019 Jul;2019(7)

Diagnostic and Interventional Radiology, University of Pisa, Via Paradisa, Pisa, Italy.

Median arcuate ligament syndrome (MALS) is a rare condition in which the median arcuate ligament (MAL) causes compression of the coeliac trunk. The chronic compression leads to coeliac trunk luminal narrowing and reduced blood supply to the abdominal splanchnic organs with possible local complications such as pseudo-aneurysms and spontaneous bleeding. Its incidence is probably underestimated due to the poor availability of color Doppler ultrasonography (CD-US), especially in an Emergency Department (ED) setting. A 44-year old woman presented to Pisa University Hospital ED with acute abdominal pain. An abdominal ultrasonography scan (US scan) was performed showing the presence of free liquid in the Douglas pouch. The abdominal computed tomography scan (CT scan) highlighted the presence of a large mesenteric hematoma. A CD-US revealed a significant stenosis of the coeliac artery. A selective angiography confirmed the diagnosis of MALS with a pseudo-aneurysm of the inferior pancreatic-duodenal artery, which was successfully embolized.
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http://dx.doi.org/10.1093/omcr/omz067DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6660059PMC
July 2019

Update on cardiac implantable electronic devices: from the injectable loop recorder to the leadless pacemaker, to the subcutaneous defibrillator.

Minerva Cardioangiol 2018 Dec;66(6):762-769

Division of Cardiology, San Filippo Neri Hospital, Rome, Italy.

A very fast-paced improvement of technology in the field of cardiac implantable devices has been observed in the last ten years. The aim of this review is to highlight the most important innovations which have been recently introduced in this field, such as the leadless pacemaker (a heart stimulator without intracardiac leads), the subcutaneous defibrillator (a completely extracardiac defibrillator device), the injectable loop recorder (a miniaturized subcutaneous continuous echocardiographic monitor provided by alarms and telephonic transmission) and many other new devices which will completely change the clinical practice in this field over the next decade.
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http://dx.doi.org/10.23736/S0026-4725.18.04693-5DOI Listing
December 2018

Exploring PTSD in emergency operators of a major University Hospital in Italy: a preliminary report on the role of gender, age, and education.

Ann Gen Psychiatry 2018 4;17:17. Epub 2018 May 4.

1Section of Psychiatry, Department of Clinical and Experimental Medicine, University of Pisa, Via Roma 67, 56100 Pisa, Italy.

Background: Emergency services personnel face frequent exposure to potentially traumatic events, with the potential for chronic symptomatic distress. The DSM-5 recently recognized a particular risk for post-traumatic stress disorder (PTSD) among first responders (criterion A4) but data are still scarce on prevalence rates and correlates.

Objective: The aim of the present study was to explore the possible role of age, gender, and education training in a sample of emergency personnel diagnosed with DSM-5 PTSD.

Methods: The Trauma and Loss Spectrum-Self-Report (TALS-SR) and the Work and Social Adjustment Scale (WSAS) were administered to 42 between nurses and health care assistants, employed at the emergency room of a major University Hospital (Pisa) in Italy.

Results: 21.4% of the sample reported DSM-5 PTSD with significantly higher scores in the TALS-SR domain exploring the acute reaction to trauma and losses among health care assistants, older, and non-graduated subjects. A significant correlation between the number of the TALS-SR symptoms endorsed, corresponding to DSM-5 PTSD diagnostic criteria emerged in health care assistants.

Conclusions: Despite further studies are needed in larger samples, our data suggest a high risk for PTSD and post-traumatic stress spectrum symptoms in nurses and health care workers operating in an emergency department, particularly among health care assistants, women, older, and non-graduated operators.
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http://dx.doi.org/10.1186/s12991-018-0184-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5935923PMC
May 2018

Electrocardiographic characteristics, anthropometric features, and cardiovascular risk factors in a large cohort of adolescents.

Europace 2018 11;20(11):1833-1840

Clinical Research Department, Biotronik Italy S.p.A, viale delle industrie 11, Vimodrone, Milan, Italy.

Aims: The characteristics of electrocardiographic (ECG) patterns in the general population of adolescents are insufficiently defined. The purpose of this study is to report ECG patterns and their association with anthropometric characteristics.

Methods And Results: Twenty-four thousand and sixty-two students of Roman schools, aged 12-19, were screened with ECG and physical examinations. Electrocardiographic abnormalities were classified as either minor/non-clinically relevant or major, and anthropometric measures were evaluated per age class. Obesity prevalence was 20.9%, with a higher rate in younger students (P < 0.008 for all comparisons, except for the pair 16-17 vs. 18-19 years). Stage 1 hypertension was found in 3.14% of adolescents, Stage 2 hypertension in 0.45% of adolescents, and isolated systolic hypertension in 11.7% of adolescents. Heart rate and QT interval corrected for heart rate (QTc) decreased with increasing age. The QTc was longer in females than in males over 14 years. A higher rate of incomplete right bundle branch block (RBBB) was observed in underweight students (21.58% vs. 15.10% in non-underweight students, P < 0.0001). Complete RBBB was the most common major ECG abnormality (1.6%). It was associated with height irrespective of age, sex, and body mass index (odds ratio 17.9; 95% confidence interval 5.0-64.6) and more frequent in students regularly practicing physical activity (1.80% vs. 1.02%, P = 0.0009).

Conclusion: Heart rate and QTc decreased with increasing age. The QTc was longer in females than in males over 14 years. RBBB was the most common major abnormality and was associated with higher stature. The prevalence of some cardiovascular risk factors in adolescents is provided.
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http://dx.doi.org/10.1093/europace/euy073DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6212775PMC
November 2018

Intracranial hemorrhage in anticoagulated patients with mild traumatic brain injury: significant differences between direct oral anticoagulants and vitamin K antagonists.

Intern Emerg Med 2018 Oct 8;13(7):1077-1087. Epub 2018 Mar 8.

Emergency Department, Nuovo Santa Chiara Hospital, U.O. Medicina d'Urgenza e Pronto Soccorso, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.

Prognosis after mild traumatic brain injury (MTBI) on oral anticoagulant therapy (OAT) is uncertain. We evaluated the rate of immediate and delayed traumatic intracranial hemorrhage (ICH) comparing vitamin K antagonists (VKAs) to direct oral anticoagulants (DOACs) and the safety of a clinical management protocol. In this single-center prospective observational study, we enrolled 220 patients on OAT with MTBI. After a first negative CT scan, asymptomatic patients underwent a close neurological observation; if neurologically stable, they were discharged without a second CT scan and followed up for 1 month. Out of the 220 patients, 206 met the inclusion criteria. 23 of them (11.2%) had a positive first CT scan for ICH. Only 1 (0.5%, 95% CI 0.0-1.4%) died because of ICH; no one required neurosurgical intervention. The observed prevalence rate of immediate ICH resulted statistically higher in VKAs-treated patients compared to those treated with DOACs (15.7 vs. 4.7%, RR 3.34, 95% CI 1.18-9.46, P < 0.05). In the 1-month follow-up, 5 out of the 183 patients with a negative CT scan were lost. Out of the remaining 178 patients, only 3 showed a delayed ICH (1.7%, 95% CI 0.0-3.6%), 1 of them died (0.6%, 95% CI 0.5-1.7%) and the others did not require neurosurgical intervention. DOACs resulted safer than VKAs also in the setting of MTBI. In our observation, the rate of delayed hemorrhage was relatively low. Patients presenting with a negative first CT scan and without neurological deterioration could be safely discharged after a short period of in-ward observation with a low rate of complications and without a second CT scan.
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http://dx.doi.org/10.1007/s11739-018-1806-1DOI Listing
October 2018

Direct oral anticoagulants in patients undergoing cardioversion: insight from randomized clinical trials.

Monaldi Arch Chest Dis 2017 05 18;87(1):805. Epub 2017 May 18.

San Filippo Neri Hospital.

Anticoagulation, reducing the risk of thromboembolic events in patients undergoing cardioversion, is a cornerstone of peri-cardioversion management in patients with atrial fibrillation. We aimed to analyse published data on the efficacy and safety of direct oral anticoagulants (DOACs) in patients undergoing cardioversion. We performed a systematic review of randomized prospective clinical trials (RCTs) comparing DOACs with warfarin and reporting data on post-cardioversion outcomes of interest. Outcomes of interest were stroke, systemic thromboembolic events and major bleeding. We reviewed a total of six RCTs including 3900 cardioversions performed using a DOAC for thromboembolic prophylaxis. These studies reported a low incidence overall of adverse outcomes associated with the use of DOACs (around 1% in all studies, except the ROCKET post-hoc study which included ablation procedures). The incidence rate of adverse events during DOAC treatment was found to be very similar to that observed with warfarin anticoagulation. In RCTs DOAC treatment in patients undergoing cardioversion appears to be effective and safe. However, because evidence in this clinical setting is still weak, observational reports could be useful in providing further data about peri-procedural outcomes.
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http://dx.doi.org/10.4081/monaldi.2017.805DOI Listing
May 2017

Short and long-term mortality of patients presenting with bleeding events to the Emergency Department.

Am J Emerg Med 2017 Dec 12;35(12):1867-1872. Epub 2017 Jun 12.

North-West District Tuscany HealthCare, Cisanello General Hospital and University of Pisa, Emergency Department, Pisa, Italy.

Background: Death of patients presenting with bleeding events to the Emergency Department still represent a major problem. We sought to analyze clinical characteristics associated with worse outcomes including short- and long-term death, beyond antithombotic treatment strategy.

Methods: Patients presenting with any bleeding events during 2016-2017years were enrolled. Clinical parameters, site of bleeding, major bleeding, ongoing anti-thrombotic treatment strategy and death were collected. Hard 5:1 propensity score matching was performed to adjust dead patients in baseline characteristics. Endpoints were one-month and one-year death.

Results: Out of 166,000 visits to the Emergency Department, 3.050 patients (1.8%) were enrolled and eventually 429 were analyzed after propensity. Overall, anticoagulants or antiplatelets were given to 234(54%). Major bleeding account for 111(26%) patients, without differences between those taking anticoagulants or antiplatelets versus others. Death at one-month and one-year was 26(6%) and 72(17%), respectively. Independent predictors of one-month death were major bleeding (Odds Ratio, OR 26, p<0.001), female gender (OR 7, p<0.001) and white blood cells (OR 1.2, p=0.01); of one-year were major bleeding (OR 7, p<0.001), age (OR 1.1, p<0.001) and female gender (OR 2.3, p=0.043). Of note, death rate of gastrointestinal and intracranial bleeding where higher than others (p<0.001). Overall mortality was approximately 40% on one-month; 60% in older patients and 80% in female gender with CHADVASC-score≥2. Receiver operator characteristics analysis showed larger areas for major bleeding and age (0.75 and 0.72, respectively) over others; p<0.05 on C-statistic.

Conclusions: In patients with bleeding events, death rate was driven by major bleeding on short-term and older age on long-term. Among dead patients mortality was approximately 40% on one-month; 60% in older patients, and 80% in female gender.
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http://dx.doi.org/10.1016/j.ajem.2017.06.025DOI Listing
December 2017

[Marcato aumento delle concentrazioni di procalcitonina dopo idroclorotiazide-edema polmonare indotta.]

Recenti Prog Med 2017 Apr;108(4):197-199

Emergency Department, AOUP, Pisa, Italy.

Introduction: In the Medline database there are approximately 60 cases reporting toxic pulmonary edema, a life-threatening event, induced after consumption of hydrochlorothiazide, one of the most common antihypertensive drugs. Moreover, increased procalcitonin concentrations have been reported after cardiogenic pulmonary edema. We report the rare case of a hydrochlorothiazide-induced pulmonary edema, which was followed by a marked increase of the procalcitonin concentrations.

Clinical Case: A middle-aged woman was admitted to the Emergency Department for severe dyspnea and chills. Such symptoms began 30 minutes after consumption of hydrochlorothiazide. Her physical examination and chest-X-ray were compatible with pulmonary edema, however her brain natriuretic peptide levels and echocardiogram were almost normal. Interestingly she had extremely elevated procalcitonin concentrations with normal white blood cells count and C-reactive protein levels only mildly increased. We hypothesized toxic pulmonary edema and started treatment with non-invasive mechanical ventilation, with the patient presenting rapid clinical improvement.

Conclusions: Even if extremely rare, hydrochlorothiazide may induce pulmonary edema; significant increase of procalcitonin concentrations may occur in this condition and perhaps in other cases of toxic pulmonary edema. Practitioners should be aware of this condition in order to spare expensive and useless, in this case, investigations such as blood cultures and treatments (antibiotics) if other signs of infection are absent.
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http://dx.doi.org/10.1701/2681.27456DOI Listing
April 2017

[Electromagnetic interference in the current era of cardiac implantable electronic devices designed for magnetic resonance environment].

G Ital Cardiol (Rome) 2017 Apr;18(4):295-304

Centro Studi Regionale per la Diagnosi e Cura delle Aritmie Cardiache, Presidio Ospedaliero San Filippo Neri, Roma.

In the last decades we are observing a continuous increase in the number of patients wearing cardiac implantable electronic devices (CIEDs). At the same time, we face daily with a domestic and public environment featured more and more by the presence and the utilization of new emitters and finally, more medical procedures are based on electromagnetic fields as well. Therefore, the topic of the interaction of devices with electromagnetic interference (EMI) is increasingly a real and actual problem.In the medical environment most attention is paid to magnetic resonance, nevertheless the risk of interaction is present also with ionizing radiation, electrical nerve stimulation and electrosurgery. In the non-medical environment, most studies reported in the literature focused on mobile phones, metal detectors, as well as on headphones or digital players as potential EMI sources, but many other instruments and tools may be intentional or non-intentional sources of electromagnetic fields.CIED manufacturers are more and more focusing on new technological features in order to make implantable devices less susceptible to EMI. However, patients and emitter manufacturers should be aware that limitations exist and that there is not complete immunity to EMI.
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http://dx.doi.org/10.1714/2683.27472DOI Listing
April 2017

Clinical differences among the elderly admitted to the emergency department for accidental or unexplained falls and syncope.

Clin Interv Aging 2017 13;12:687-695. Epub 2017 Apr 13.

Geriatrics Unit.

It is difficult to distinguish unexplained falls (UFs) from accidental falls (AFs) or syncope in older people. This study was designed to compare patients referred to the emergency department (ED) for AFs, UFs or syncope. Data from a longitudinal study on adverse drug events diagnosed at the ED (ANCESTRAL-ED) in older people were analyzed in order to select cases of AF, syncope, or UF. A total of 724 patients (median age: 81.0 [65-105] years, 66.3% female) were consecutively admitted to the ED (403 AF, 210 syncope, and 111 UF). The number of psychotropic drugs was the only significant difference in patients with AF versus those with UF (odds ratio [OR] 1.44; 95% confidence interval 1.17-1.77). When comparing AF with syncope, female gender, musculoskeletal diseases, dementia, and systolic blood pressure >110 mmHg emerged as significantly associated with AF (OR 0.40 [0.27-0.58], 0.40 [0.24-0.68], 0.35 [0.14-0.82], and 0.31 [0.20-0.49], respectively), while valvulopathy and the number of antihypertensive drugs were significantly related to syncope (OR 2.51 [1.07-5.90] and 1.24 [1.07-1.44], respectively). Upon comparison of UF and syncope, the number of central nervous system drugs, female gender, musculoskeletal diseases, and SBP >110 mmHg were associated with UF (OR 0.65 [0.50-0.84], 0.52 [0.30-0.89], 0.40 [0.20-0.77], and 0.26 [0.13-0.55]), respectively. These results indicate specific differences, in terms of demographics, medical/pharmacological history, and vital signs, among older patients admitted to the ED for AF and syncope. UF was associated with higher use of psychotropic drugs than AF. Our findings could be helpful in supporting a proper diagnostic process when evaluating older patients after a fall.
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http://dx.doi.org/10.2147/CIA.S127824DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5399985PMC
October 2017

Economic analysis of remote monitoring of cardiac implantable electronic devices: Results of the Health Economics Evaluation Registry for Remote Follow-up (TARIFF) study.

Heart Rhythm 2017 01 8;14(1):50-57. Epub 2016 Sep 8.

Department of Cardiology, San Filippo Neri Hospital, Rome, Italy.

Background: Remote monitoring (RM) of cardiac implantable electronic devices has been demonstrated to improve outpatient clinic workflow and patient management. However, few data are available on the socioeconomic impact of RM.

Objective: The aim of this study was to assess the costs and benefits of RM compared with standard care (SC).

Methods: We used 12-month patient data from the Health Economics Evaluation Registry for Remote Follow-up (TARIFF) study (N = 209; RM: n = 102 (48.81%); SC: n = 107 (51.19%)). Cost comparison was made from 2 perspectives: the health care system (HCS) and patients. The use of health care resources was defined on the basis of hospital clinical folders. Out-of-pocket expenses were reported directly by patients.

Results: HCS perspective: The overall mean annual cost per patient in the SC group (€1044.89 ± €1990.47) was significantly higher than in the RM group (€482.87 ± €2488.10) (P < .0001), with a reduction of 53.87% being achieved in the RM group. The primary driver of cost reduction was the cost of cardiovascular hospitalizations (SC: €`886.67 ± €1979.13 vs RM: €432.34 ± €2488.10; P = .0030). Patient and caregiver perspective: The annual cost incurred by patients was significantly higher in the SC group than in the RM group (SC: €169.49 ± €189.50 vs RM: €56.87 ± €80.22; P < .0001). Patients' quality-adjusted life-years were not significantly different between the groups. Provider perspective: The total number of inhospital device follow-up visits was reduced by 58.78% in the RM group.

Conclusion: RM of patients with cardiac implantable electronic devices (CIEDs) is cost saving from the perspectives of the HCS, patients, and caregivers. Introducing appropriate reimbursements will make RM sustainable even for the provider, i.e. the hospitals which provide the service and encourage widespread adoption of RM.
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http://dx.doi.org/10.1016/j.hrthm.2016.09.008DOI Listing
January 2017

Novel devices to monitor heart failure and minimize hospitalizations.

Expert Rev Cardiovasc Ther 2016 Aug 28;14(8):905-13. Epub 2016 May 28.

d Centro Studi Regionale per la Diagnosi e Cura delle Aritmie Cardiache , Rome , Italy.

Introduction: Approximately 1-2% of the adult population in developed countries is affected by heart failure. The costs of heart failure are enormous both in Europe and in the US and are expected to rise. New technologies and remote monitoring, are valid tools for the management and treatment of these patients.

Areas Covered: This review aims to cover both implantable and non-implantable devices available for monitoring various hemodynamic parameters and clinical features of patients, as well as algorithms implemented in the new generation ICDs and CRTs capable of simultaneous acquisition and transmission of multiple parameters that indirectly evaluate clinical and/or hemodynamic status. Both internet and PubMed searches were used in order to acquire the most recent developments in the technology of the field. Expert commentary: As new technology offers an enormous data flow, the key for success in the battle against heart failure and related hospitalizations is understanding the correct way of utilizing the data acquired and their importance for the treatment of each individual person.
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http://dx.doi.org/10.1080/14779072.2016.1187064DOI Listing
August 2016

DSM-5 PTSD and posttraumatic stress spectrum in Italian emergency personnel: correlations with work and social adjustment.

Neuropsychiatr Dis Treat 2016 18;12:375-81. Epub 2016 Feb 18.

Department of Clinical and Experimental Medicine, Section of Psychiatry, University of Pisa, Pisa, Italy.

The Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) has recently recognized a particular risk for posttraumatic stress disorder (PTSD) among first responders (criterion A4), acknowledging emergency units as stressful places of employment. Little data is yet available on DSM-5 among emergency health operators. The aim of this study was to assess DSM-5 symptomatological PTSD and posttraumatic stress spectrum, as well as their impact on work and social functioning, in the emergency staff of a major university hospital in Italy. One hundred and ten subjects (doctors, nurses, and health-care assistants) were recruited at the Emergency Unit of the Azienda Ospedaliero-Universitaria Pisana (Italy) and assessed by the Trauma and Loss Spectrum-Self Report (TALS-SR) and Work and Social Adjustment Scale (WSAS). A 15.7% DSM-5 symptomatological PTSD prevalence rate was found. Nongraduated persons reported significantly higher TALS-SR Domain IV (reaction to loss or traumatic events) scores and a significantly higher proportion of individuals presenting at least one maladaptive behavior (TALS-SR Domain VII), with respect to graduate ones. Women reported significantly higher WSAS scores. Significant correlations emerged between PTSD symptoms and WSAS total scores among health-care assistants, nongraduates and women. Our results showed emergency workers to be at risk for posttraumatic stress spectrum and related work and social impairment, particularly among women and nongraduated subjects.
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http://dx.doi.org/10.2147/NDT.S97171DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4762463PMC
March 2016

Prevalence and predictor factors of severe venous obstruction after cardiovascular electronic device implantation.

Europace 2016 Aug 24;18(8):1220-6. Epub 2015 Dec 24.

Cardiovascular Department, San Filippo Neri Hospital, via Martinotti 20, Rome 00135, Italy.

Aims: Despite not being uncommon, limited evidence exists about predisposing factors for venous obstruction in patients with implantable electronic devices. We aimed to assess the prevalence of severe venous obstruction in patients with intravenous devices and identify predictor factors.

Methods And Results: A total of 184 patients underwent venography to detect venous obstruction associated with the inserted lead. Vessel obstruction was graded as venous occlusion (complete flow interruption), severe obstruction (narrowing >90%), or mild-moderate obstruction (narrowing 50-90%). Severe venous obstruction/occlusion prevalence was 11.4% (n = 21) and was always asymptomatic. Collateral circulation was found in 80.9% of patients with severe obstruction/occlusion. Twelve patients (6.5%) had 3 leads. The rates of patients with secondary prevention of sudden cardiac death as indication for implantable devices and of those of patients with 3 leads were significantly greater in the group with severe obstruction/occlusion than in the non-severe obstruction/occlusion group (respectively, P = 0.004 and P = 0.03). Logistic analysis adjusted for venous thromboembolic risk factors confirmed that secondary prevention of sudden cardiac death as indication for implantable devices [odds ratio (OR), 7.1; 95% confidence interval (CI): 1.4-35.3; P = 0.017] and the presence of 3 leads (OR, 8.5; 95% CI: 1.75-41.35; P = 0.008) were predictors of severe obstruction/occlusion.

Conclusion: In patients with implantable devices, severe venous obstruction prevalence is not negligible and the lack of symptoms does not exclude it. The presence of three leads and sudden cardiac death as indication for implantable devices seem to be associated with the presence of severe venous obstruction/occlusion.
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http://dx.doi.org/10.1093/europace/euv391DOI Listing
August 2016

The role of implantable devices to treat atrial fibrillation.

Future Cardiol 2015 26;11(6):689-95. Epub 2015 Nov 26.

Cardiovascular Department, A.O.C. San Filippo Neri, Rome, Italy.

In the last decades several nonpharmacological therapies for the treatment and prevention of atrial fibrillation (AF) have been developed. Pacemakers play a potential important role in the nonpharmacological management of AF. In patients with sinus node dysfunction both, atrial and dual-chamber pacing, have been proven to prevent or delay progression to permanent AF compared with ventricular pacing alone. However, in patients without conventional indications for pacing, the utility of pacemakers as a stand-alone therapy has not yet proven. Following the positive results obtained by low energy internal defibrillation, specific implantable devices for AF cardioversion have been developed. Despite implantable atrial defibrillators being possible alternatives for drug refractory AF, industry did not further develop these due to shock discomfort. Newer implantable pulse generators also offer data storage that permits detection of asymptomatic AF. Such a help provided by implantable devices, has been enhanced by the development and spread out of remote monitoring systems.
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http://dx.doi.org/10.2217/fca.15.61DOI Listing
September 2016

Early invasive versus early conservative strategy in non-ST-elevation acute coronary syndrome: An outcome research study.

Eur Heart J Acute Cardiovasc Care 2017 Sep 2;6(6):477-489. Epub 2015 Jul 2.

1 San Filippo Neri Hospital, Rome, Italy.

Background: An early invasive strategy (EIS) has been shown to yield a better clinical outcome than an early conservative strategy (ECS) in patients with non-ST-elevation acute coronary syndromes (NSTEACSs), particularly in those at higher risk according to the GRACE risk score. However, findings of the clinical trials have not been confirmed in registries.

Objective: To investigate the outcome of patients with NSTEACS treated according to an EIS or a ECS in a real-world all-comers outcome research study.

Methods: The primary hypothesis of the study was the non-inferiority of an ECS in comparison with an EIS as to a combined primary end-point of death, non-fatal myocardial infarction and hospital readmission for acute coronary syndromes at one year. Participating centres were divided into two groups: those with a pre-specified routine EIS and those with a pre-specified routine ECS. Two statistical analyses were performed: a) an 'intention to treat' analysis: all patients were considered to be treated according to the pre-specified routine strategy of that centre; b) a 'per protocol' analysis: patients were analysed according to the actual treatment applied. Cox model including propensity score correction was applied for all analyses.

Results: The intention to treat analysis showed an equivalence between EIS and ECS (11.4% vs. 11.1%) with regard to the primary end-point incidence at one year. In the three subgroups of patients according to the GRACE risk score (⩽ 108, 109-140, > 140), EIS and ECS confirmed their equivalence (5.3% vs. 3.9%, 8.4% vs. 7.6%, and 20.3% vs. 20.9%, respectively). When the per protocol analysis was applied, a reduction of the primary end-point at one year with EIS vs. ECS was demonstrated (6.2% vs. 15.3%, p=0.021); analysis of the subgroups according to the GRACE risk score numerically confirmed these data (3.1% vs. 6.5%, 5.1% vs. 10.0%, and 10.8% vs. 24.5%, respectively).

Conclusions: In a real-life registry of all-comers NSTEACS patients, ECS was non-inferior to EIS; however, when EIS was applied according to clinical judgement, a reduction of clinical events at one year was demonstrated.
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http://dx.doi.org/10.1177/2048872615590145DOI Listing
September 2017

Access to emergency room for hypoglycaemia in people with diabetes.

Diabetes Metab Res Rev 2015 Oct 14;31(7):745-51. Epub 2015 Jul 14.

Department of Clinical and Experimental Medicine - Section of Diabetes and Metabolic Diseases, University of Pisa, Pisa, Italy.

Background: Hypoglycaemia is a major burden of the pharmacological therapy of diabetes and is associated with increased morbidity, mortality and treatment costs.

Methods: We screened all admissions to the emergency room of the Pisa University Hospital from 1 January 2009 to 31 December 2013, selecting individuals with a discharge diagnosis of hypoglycaemia. We retrieved 500 admissions involving adult diabetic patients: age 71 ± 16 years; M/F 50.2/49.8%; 70.2% type 2 diabetes (T2DM).

Results: Among T2DM, 42.2% were on insulin, 10.8% on insulin plus oral anti-diabetes drugs and 38.2% on oral anti-diabetes drugs alone (92% sulphonylureas/glinides ± insulin-sensitizers). Glibenclamide was the most frequently used sulphonylurea (69%). Individuals treated with oral anti-diabetes drugs were older than those on insulin (79 ± 11 versus 74 ± 12 years; p < 0.0001). Among patients taking sulphonylurea, 47% had estimated glomerular filtration rate <60 mL/min/1.73 m(2) and 13.5% had <30 mL/min/1.73 m(2) . In-hospital admission occurred in 20% of cases. Hospitalized patients with T2DM were older than those discharged (80 ± 10 versus 76 ± 12 years, p < 0.01) and were on oral antidiabetic drugs in 54.8% of the cases, whereas 35.7% were on insulin (χ(2) , p < 0.0001) and 8.3% on combined therapy. Notably, 93.5% of those on oral anti-diabetic drugs were taking a secretagogue. Insulin-treated subjects were younger than those treated with oral anti-diabetic drugs alone (77 ± 12 versus 82 ± 7 years; p < 0.02). The mean in-hospital annual mortality rate was 85 deaths per 1000 patients-year.

Conclusions: Our results support the recommendation that the risk associated with insulin and insulin-secretagogues should be carefully assessed, particularly when prescribed in vulnerable patients with T2DM.
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http://dx.doi.org/10.1002/dmrr.2667DOI Listing
October 2015

Validation of a simple risk stratification tool for patients implanted with Cardiac Resynchronization Therapy: the VALID-CRT risk score.

Eur J Heart Fail 2015 Jul 23;17(7):717-24. Epub 2015 Apr 23.

Aston University Medical School and Queen Elizabeth Hospital, Birmingham, UK.

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.
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http://dx.doi.org/10.1002/ejhf.269DOI Listing
July 2015

Effects of enhanced pacing modalities on health care resource utilization and costs in bradycardia patients: An analysis of the randomized MINERVA trial.

Heart Rhythm 2015 Jun 19;12(6):1192-200. Epub 2015 Feb 19.

Institute of Internal Medicine and Cardiology, University of Florence, Florence, Italy.

Background: Many patients who suffer from bradycardia and need cardiac pacing also have atrial fibrillation (AF). New pacemaker algorithms, such as atrial preventive pacing and atrial antitachycardia pacing (DDDRP) and managed ventricular pacing (MVP), have been specifically designed to reduce AF occurrence and duration and to minimize the detrimental effects of right ventricular pacing. The randomized MINimizE Right Ventricular pacing to prevent Atrial fibrillation and heart failure trial established that DDDRP + MVP pacing modality reduced permanent AF in bradycardia patients as compared with standard dual-chamber pacing (DDDR).

Objective: The aim of this study was to estimate the cost savings due to lower AF-related health care utilization events based on health care costs from the United States and the European Union.

Methods: Dual-chamber pacemaker patients with a history of paroxysmal or persistent AF were randomly assigned to receive DDDR (n = 385) or the advanced features (DDDRP + MVP; n = 383). We used published health care costs from the United States and the European Union (Italy, Spain, and the United Kingdom) to estimate the costs associated with AF-related hospitalizations and emergency visits.

Results: The rate of AF-related hospitalizations was significantly lower in the DDDRP + MVP group than in the conventional pacemaker group (DDDR group; 42% reduction; incidence rate ratio 0.58). Similarly, a significant reduction of 68% was observed for AF-related emergency department visits (incidence rate ratio 0.32; P < .001). As a consequence, DDDRP + MVP could potentially reduce health care costs by 40%-44%. Over a ten-year period, the cost savings per 100 patients ranged from $35,702 in the United Kingdom to $121,831 in the United States.

Conclusion: New pacing algorithms such as DDDRP + MVP used in the MINimizE Right Ventricular pacing to prevent Atrial fibrillation and heart failure trial successfully reduced AF-related health care utilization, resulting in significant cost savings to payers.
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http://dx.doi.org/10.1016/j.hrthm.2015.02.017DOI Listing
June 2015
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