InnovaPuglia

To compare two sodium hyaluronate formulations (HYMOVIS® ONE and MONOVISC®) for single intra-articular (IA) injection in patients with knee osteoarthritis pain. This randomized, controlled study included 347 subjects allocated to two treatment arms: HYMOVIS® ONE (n = 175) and MONOVISC® (n = 172). The primary endpoint assessed non-inferiority of HYMOVIS® ONE versus MONOVISC® based on change from baseline in the WOMAC LK3.1 A1 Pain subscale. Secondary outcomes evaluated patient response using OMERACT-OARSI criteria, changes in WOMAC stiffness and function scores, health-related quality of life (SF-12), global assessments by patients and clinicians, and rescue medication use. The mean WOMAC LK3.1 A1 walking pain subscale score decreased significantly from baseline at week 12 in both groups, with reductions of 65 % for HYMOVIS® ONE and 66 % for MONOVISC®. At week 26, reductions were 73 % for HYMOVIS® ONE and 69 % for MONOVISC®. The non-inferiority test yielded a p-value of 0.0003. Clinically significant change from baseline was observed for all secondary endpoints. For the WOMAC LK3.1 Function subscale, the comparison between groups at week 26 showed a statistically significant difference (p = 0.0367) favoring HYMOVIS® ONE. Both treatments were well tolerated. A single injection of HYMOVIS® ONE was well tolerated and non-inferior to MONOVISC®, with improvements across all study endpoints maintained through 26 weeks, indicating sustained symptomatic relief of knee OA. NCT06528600 (www.clinicaltrials.gov).

BackgroundThe resorbable magnesium scaffold (RMS) is a second-generation bioresorbable scaffold (BRS) that has shown conflicting results in previous studies. These findings suggest that patient selection and implantation technique may have an impact on clinical outcomes. This study aimed to investigate the safety and long-term effectiveness of RMS in a narrowly selected population. MethodsSHERPA-MAGIC is an investigator-driven, multicenter, prospective, single-arm study that enrolled patients undergoing BRS coronary implantation in 18 Italian centers. The present analysis considered the first 543 enrolled patients treated with RMS, with a minimum follow-up of 1 year. The study protocol included strict criteria for patient selection and standardization of RMS implantation. The primary outcome was the occurrence of the vessel-oriented composite endpoints (VOCE), including cardiac death, target vessel myocardial infarction, and ischemia-driven target vessel revascularization. ResultsOverall, 635 vessels were treated. The 1-year cumulative occurrence of VOCE was 22 (3.5%, 95% CI 2.2%–5.2%), which was significantly lower than the prespecified estimation (from 5.5% to 8.5%). At the median follow-up of 3.5 [2.6–4.3] years, there were 3 (0.5%) cardiac deaths, 12 (1.9%) target vessel myocardial infarctions, and 33 (5.2%) ischemia-driven target vessel revascularizations. A total of 37 (5.8%, 95%CI 4.1%–7.9%) VOCEs were detected. Scaffold thrombosis occurred in 4 (0.6%, 95%CI 0.1%–1.6%) cases. Patient-level analysis confirmed the findings of the vessel-level analysis. ConclusionsThese results confirm the safety and performance of RMS technology. If confirmed in randomized controlled trials, they may rekindle interest in the use of scaffolds in daily practice.

Patients with acute coronary syndromes (ACS) requiring percutaneous coronary intervention (PCI) with stent implantation not rarely present a concomitant atrial fibrillation (AF).1,2 Such patients have long been treated with oral anticoagulation (OAC) and dual antiplatelet therapy (DAPT), a combination known as triple antithrombotic therapy (TAT), in order to decrease both the risk of thromboembolism due to AF and the risk of recurrent ischaemic events due to ACS and coronary stents.1–5 Recently, several randomized trials demonstrated that a double antithrombotic therapy (DAT), which combines OAC with an oral P2Y12 receptor inhibitor, is associated with a significantly lower rate of bleeding complications as compared to TAT with a higher risk of stent-related events, but comparable cerebrovascular ischaemic occurrences.6–10 Nationwide data describing combinations of antithrombotic agents currently used in patients with AF and ACS treated with PCI are scarce. The MATADOR-PCI (Management of Antithrombotic TherApy in Patients with...

This study was designed to assess the prognostic value of clinical and electrocardiographic parameters in Brugada syndrome (BrS). The study population included 272 consecutive patients (82% males; mean age 43 ± 12 years), with either a spontaneous (n = 137, 50%) or drug-induced (n = 135, 50%) Type 1 Brugada electrocardiogram (ECG) pattern. The study combined endpoint included sudden cardiac death (SCD), cardiac arrest, and appropriate intervention of implantable cardioverter-defibrillator (ICD). A first-degree atrioventricular (AV) block (PR = 219 ± 17 ms) was documented at basal ECG in 45 patients (16.5%); 27 of these underwent an electrophysiological study with recording in 21 (78%) of an HV interval ≥55 ms (mean 61 ± 3 ms). Patients with first-degree AV block had a wider QRS complex (median 110 ms vs. 95 ms; P = 0.04) and more often showed a left anterior hemiblock pattern (n = 13, 29% vs. n = 35, 16%; P = 0.056). During a mean follow-up of 85 ± 55 months, 17 patients (6.3%) experienced ≥1 major arrhythmic events (appropriate ICD intervention, n = 13 and SCD, n = 4). At univariate analysis, the occurrence of major arrhythmic events was significantly associated with a history of syncope or cardiac arrest (P < 0.001), Type 1 ECG pattern (P = 0.04), and first-degree AV block (P < 0.001). Univariate and multivariable predictors of events included a history of syncope or cardiac arrest [hazard ratio (HR) 5.8, 95% confidence interval (95% CI) 2.04-16.5; P < 0.001; and HR 6.68, 95% CI 2.34-19.1; P < 0.001; respectively], a spontaneous Type 1 ECG pattern (HR 1.56, 95% CI 1.03-4.24; P = 0.033; and HR 1.84, 95% CI 1.01-4.29; P = 0.044; respectively) and a first-degree AV block at baseline ECG (HR 3.84, 95% CI 1.47-9.99; P = 0.006; and HR 4.65, 95% CI 2.34-19.1; P = 0.002; respectively). Besides a history of cardiac arrest or syncope, first-degree AV block on basal ECG is an independent predictor of malignant arrhythmic events and a stronger marker of arrhythmic risk than a spontaneous 'coved-type' ECG pattern in patients with BrS.

Introduction: Subcutaneous ICD (S-ICD) is a promising option for Hypertrophic Cardiomyopathy (HCM) patients at high-risk of Sudden Cardiac Death (SCD). However, its efficacy in terminating ventricular arrhythmias in HCM is yet unresolved. Hypothesis: To determine the efficacy of post-implantation S-ICD defibrillation testing (DT) of Ventricular Fibrillation (VF) in HCM patients and assess possible predictors of failure. Methods: Consecutive HCM patients referred for S-ICD implantation at seven Italian Centers from June 2014 to May 2016 were prospectively enrolled. At S-ICD implantation, patients underwent one or two attempts of VF induction by programmed electrical stimulation. Successful conversion was defined as any 65j shock that terminated VF and did not require rescue shocks. Clinical, ECG and Echocardiographic findings were analyzed to study potential predictors of conversion failure. Results: We evaluated 50 HCM patients (34 males, mean age 40±16) with a mean BMI of 25.2±4.4 kg/m 2 [18.1-36]. Two patients (4%) had a history of cardiac arrest, whereas 48 (96%) were implanted in primary prevention. Mean calculated risk of SCD at 5 years by the ESC score was 6.5±3.9% and all patients had at least one major risk factor. Maximal LV wall thickness (LVMWT) was &gt;25 mm in 19 (38%) patients and ≥ 30 mm in 13 (26 %). In 2/50 patients (4%) no arrhythmias were inducible, while in 7 (14%) only polymorphic sustained ventricular tachycardia (SVT) was induced and correctly cardioverted by the S-ICD. In the remaining 41 (82%) patients, 70 VF episodes were induced (2 VF in 29 and 1 VF in 12 patients), all correctly recognized by the device. Of the 70 VFs, 4 (6%) spontaneously converted into sinus rhythm. In 65/66 (98%) the S-ICD performed successful conversions, but failed in 1 (2%) patient, who needed rescue defibrillation. This patient was severely obese, with a BMI 36 kg/m 2 and LVMWT of 25 mm. VF was induced again and successfully converted by 80j shock with inverted polarity. Conclusions: Acute defibrillation testing at 65j shows the efficacy of S-ICD in terminating VF or polymorphic SVT in HCM patients, despite the presence of extreme LV hypertrophy. Severe obesity was possibly responsible for the single failure observed at 65j in our series.

BackgroundPatients with implantable devices such as pacemakers (PMs) and implantable cardiac defibrillators (ICDs) should be followed up every 3–12 months, which traditionally required in-clinic visits. Innovative devices allow data transmission and technical or medical alerts to be sent from the patient's home to the physician (remote monitoring). A number of studies have shown its effectiveness in timely detection and management of both clinical and technical events, and endorsed its adoption. Unfortunately, in daily practice, remote monitoring has been implemented in uncoordinated and rather fragmented ways, calling for a more strategic approach.ObjectiveThe objective of the study was to analyze the impact of remote monitoring for PM and ICD in a “real world” context compared with in-clinic follow-up. The evaluation focuses on how this service is carried out by Local Health Authorities, the impact on the cardiology unit and the health system, and organizational features promoting or hindering its effectiveness and efficiency.MethodsA multi-center, multi-vendor, controlled, observational, prospective study was conducted to analyze the impact of remote monitoring implementation. A total of 2101 patients were enrolled in the study: 1871 patients were followed through remote monitoring of PM/ICD (I-group) and 230 through in-clinic visits (U-group). The follow-up period was 12 months.ResultsIn-clinic device follow-ups and cardiac visits were significantly lower in the I-group compared with the U-group, respectively: PM, I-group = 0.43, U-group = 1.07, P<.001; ICD, I-group = 0.98, U-group = 2.14, P<.001. PM, I-group = 0.37, U-group = 0.85, P<.001; ICD, I-group = 1.58, U-group = 1.69, P=.01. Hospitalizations for any cause were significantly lower in the I-group for PM patients only (I-group = 0.37, U-group = 0.50, P=.005). There were no significant differences regarding use of the emergency department for both PM and ICD patients. In the I-group, 0.30 (PM) and 0.37 (ICD) real clinical events per patient per year were detected within a mean (SD) time of 1.18 (2.08) days. Mean time spent by physicians to treat a patient was lower in the I-group compared to the U-group (-4.1 minutes PM; -13.7 minutes ICD). Organizational analysis showed that remote monitoring implementation was rather haphazard and fragmented. From a health care system perspective, the economic analysis showed statistically significant gains (P<.001) for the I-group using PM.ConclusionsThis study contributes to build solid evidence regarding the usefulness of RM in detecting and managing clinical and technical events with limited use of manpower and other health care resources. To fully gain the benefits of RM of PM/ICD, it is vital that organizational processes be streamlined and standardized within an overarching strategy.

To evaluate the efficacy and safety of the minimally invasive Ajust™ system in the treatment of stress urinary incontinence. This was a prospective multicentre study. All patients with primary urodynamic stress urinary incontinence were prospectively selected to receive the Ajust™ procedure. The International Consultation on Incontinence-Short Form (ICI-SF), Women Irritative Prostate Symptoms Score (W-IPSS), PGI-S, and PGI-I questionnaires were used to evaluate the impact of incontinence and voiding dysfunction on QoL and to measure patient's perception of incontinence severity and improvement. From January 2009 to October 2009, 111 consecutive subjects were enrolled in the study. At 6months, 102 were available for outcomes analysis. The subjective and objective cure rates were 85.7% and 91.4%, respectively. The ICI-SF and W-IPSS questionnaires showed a statistical significant improvement in symptom scores. In the short-term follow-up, the Ajust™ system was effective in restoring continence in more than 85% of subjects with a highly significant improvement in QoL.

Both atrial flutter and atrial fibrillation (AF) frequently develop in the same patient. There is therefore reasonable doubt that flutter ablation may not solve the clinical problem, owing to the occurrence/recurrence of AF. The aim of this study was to establish whether cavo-tricuspid isthmus ablation is curative in patients with common atrial flutter alone or combined with AF. One hundred and forty-one patients (114 male, 27 female, mean age 63 +/- 10 years) who had cavo-tricuspid isthmus ablation were followed up for 44 +/- 20 months. Before ablation, 48 patients had only atrial flutter (group A), whereas 93 patients had both atrial flutter and AF. Among the latter, during antiarrhythmic therapy, 31 patients had only atrial flutter (group B1), whereas 62 patients (group B2) continued to experience both arrhythmias. During follow-up, 27% of group A and 61% of group B patients had documented recurrent AF (P < 0.001). AF recurred in 51% of group B1 and in 66% of group B2 patients (P = NS). Permanent AF occurred in 6% of group A, 3% of group B1 and 21% of group B2 (P < 0.01). Specific symptom scale scores significantly decreased in all groups, particularly in group A. Two patients of group B had cerebral ischaemic attacks. Over a long-term follow-up, cavo-tricuspid isthmus ablation is curative in >70% of patients with atrial flutter alone. Therefore, if no AF is documented, more extensive ablation is not needed. By contrast, cavo-tricuspid isthmus ablation is frequently unable to prevent AF in patients with both atrial flutter and AF, although in some cases a significant clinical benefit may be obtained.

To the Editor: We read the article by Aung et al. [1] with great interest. Observing the Figure re-creating the defect, we noticed the presence of the flow transducer of an Ohio Registered Trademark 5400 Volume Monitor (Ohio Medical Products, Madison, WI) at the expiratory limb of the absorber system. The authors said that the anesthesia system was checked preoperatively and that "several minutes after the start of surgery, the inspired CO2 began to increase." We concord with the authors that is difficult to explain how the vane-style flow transducer could not prevent the piece of plastic from reaching the valve. But we have another question: Why did the flowmeter not generate the alarm of flow reverse? This simple device should be the early sentinel of an incompetent expiration valve, immediately excluding problems in soda lime as a cause of carbon dioxide rebreathing. In the authors' anesthesia system there was not one but two inexplicable problems due to a sole monitoring device. Clemente Possamai, MD Ulisse Corbanese, MD Department of Anesthesia and Intensive Care, Ospedale Generale di Conegliano, 31015 Conegliano, Italy