105 research outputs found

    Hybrid transcatheter left ventricular reconstruction for the treatment of ischemic cardiomyopathy

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    Left ventricular (LV) enlargement is a mechanical adaptation to accommodate LV systolic inefficiency following an acute damage or a progressive functional deterioration, which fails to correct the decline of stroke volume in the long term, leading to progressive heart failure (HF). Surgical ventricular reconstruction (SVR) is a treatment for patients with severe ischemic HF aiming to restore LV efficiency by volume reduction and LV re-shaping. Recently, a new minimally-invasive hybrid technique for ventricular reconstruction has been developed by means of the Revivent (TM) system (BioVentrix Inc., San Ramon, CA, USA). The device for ventricular reconstruction consists of anchor pairs that enable plication of the anterior and free wall LV scar against the right ventricular (RV) septal scar of anteroseptal infarctions to decrease cardiac volume without ventriculotomy in a beating-heart minimally-invasive procedure, consisting of a transjugular and left thoracotomy approach. Patients with severe (Grade 4) functional mitral regurgitation (FMR) or with previous cardiac surgery procedures were excluded. Outcome of the reconstruction procedure: from 2012 until 2019, it has been applied to 203 patients, with 5 (2.5%) in-hospital deaths. LV volume reduction varied according to experience gained along years: LV end-systolic volume index decreased from baseline 43% (post-market registry) vs. 27% (CE-mark study); left ventricular ejection fraction (LVEF) increased from baseline 25% (post-market registry) vs. 16% (CE-mark study). Clinical status (NYHA class, HF questionnaire, 6-minute walking test) improved significantly compared to baseline, and re-hospitalization rate was only 13% at 6-month follow-up (60% of patients in NYHA =3). FMR grade decreased at follow-up in 63%, while it was unchanged in 37% of patients. The hybrid ventricular reconstruction (HVR) seems a promising treatment for HF patients who may benefit from LV volume reduction, with reasonable mortality and good results at follow-up. A baseline less severe clinical profile was not associated to better outcome at follow-up, which makes the procedure feasible in patients with very large ventricles and depressed ejection fraction (EF). LV reshaping has no detrimental effect on FMR, that may, on the contrary, benefit owing to less papillary muscle displacement, partial recovery of torsion dynamics and of myofibers re-orientation. A controlled study on top of optimal medical treatment is warranted to confirm its role in the management of HF patients

    REducing INFectiOns thRough Cardiac device Envelope: insight from real world data. The REINFORCE Project

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    Background: Infections resulting from cardiac implantable electronic device (CIED) implantation are severely impacting on patients' and on health care systems. The use of TYRXTM absorbable antibiotic-eluting envelope has proven to decrease major CIED infections within 12 months of CIED surgery. Aims: to evaluate the impact of the envelope use on infection-related clinical events in a real-world contemporary patient population. Methods: Data on patients undergoing CIED surgery were collected prospectively by participating centers of the One Hospital ClinicalService project. Patients were divided into two groups according to whether TYRXTM absorbable antibiotic-eluting envelope was used or not. Results: Out of 1819 patients, 872 (47.9%) were implanted with an absorbable antibiotic-eluting envelope and included in the Envelope group and 947 (52.1%) patients who did not receive an envelope were included in the Control group. Compared to control, patients in the Envelope group had higher thrombo-embolic or hemorrhagic risk, higher BMI, lower LVEF and more comorbidities. During a mean follow-up of 1.4 years, the incidence of infection-related events was significantly higher in the control compared to the Envelope group (2.4% vs 0.8%, p = 0.007). The 5-year cumulative incidence of infection-related events was 8.1% in the control and 2.1% in the Envelope group (HR: 0.34, 95%CI: 0.14-0.80, p = 0.010). Conclusions: In our analysis, the use of an absorbable antibiotic-eluting envelope in the general CIED population was associated with a lower risk of systemic and pocket infection

    The "Defibrillation Testing, Why Not?" survey. Testing of subcutaneous and transvenous defibrillators in the Italian clinical practice

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    Background: Defibrillation testing (DT) can be omitted in patients undergoing transvenous implantable cardioverter-defibrillator (T-ICD) implantation, but it is still recommended for patients at risk for a high defibrillation threshold and for ICD generator changes. Moreover, DT is still recommended on implantation of subcutaneous ICD (S-ICD). The aim of the present survey was to analyze the current practice of DT during T-ICD and S-ICD implantations.Methods: In March 2021, an ad hoc questionnaire on the current performance of DT and the standard practice adopted during testing was completed at 72 Italian centers implanting S-ICD and T-ICD.Results: 48 (67%) operators reported never performing DT during de-novo T-ICD implantations, while no operators perform it systematically. The remaining respondents perform it for patients at risk for a high defibrillation threshold. DT is never performed at T-ICD generator change. At the time of de-novo S-ICD implantation, DT is never performed by 9 (13%) operators and performed systematically by 48 (66%). The remaining operators frequently omit DT in patients with more severe systolic dysfunction. DT is not performed at S-ICD generator change by 92% of operators. DT is conducted by delivering a first shock energy of 65 J by 60% of operators, while the remaining 40% test lower energy values.Conclusions: In current clinical practice, most operators omit DT at T-ICD implantation, even when still recommended in the guidelines. DT is also frequently omitted at S-ICD implantation, and a wide variability exists among operators in the procedures followed during DT

    Differences in cardiac phenotype and natural history of laminopathies with and without neuromuscular onset

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    Objective: To investigate differences in cardiac manifestations of patients affected by laminopathy, according to the presence or absence of neuromuscular involvement at presentation.Methods: We prospectively analyzed 40 consecutive patients with a diagnosis of laminopathy followed at a single centre between 1998 and 2017. Additionally, reports of clinical evaluations and tests prior to referral at our centre were retrospectively evaluated.Results: Clinical onset was cardiac in 26 cases and neuromuscular in 14. Patients with neuromuscular presentation experienced first symptoms earlier in life (11 vs 39 years; p < 0.0001) and developed atrial fibrillation/flutter (AF) and required pacemaker implantation at a younger age (28 vs 41 years [p = 0.013] and 30 vs 44 years [p = 0.086] respectively), despite a similar overall prevalence of AF (57% vs 65%; p = 0.735) and atrio-ventricular (A-V) block (50% vs 65%; p = 0.500). Those with a neuromuscular presentation developed a cardiomyopathy less frequently (43% vs 73%; p = 0.089) and had a lower rate of sustained ventricular tachyarrhythmias (7% vs 23%; p = 0.387). In patients with neuromuscular onset rhythm disturbances occurred usually before evidence of cardiomyopathy. Despite these differences, the need for heart transplantation and median age at intervention were similar in the two groups (29% vs 23% [p = 0.717] and 43 vs 46 years [p = 0.593] respectively).Conclusions: In patients with laminopathy, the type of disease onset was a marker for a different natural history. Specifically, patients with neuromuscular presentation had an earlier cardiac involvement, characterized by a linear and progressive evolution from rhythm disorders (AF and/or A-V block) to cardiomyopathy

    Acute shock efficacy of the subcutaneous implantable cardioverter-defibrillator according to the implantation technique

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    Background: The traditional technique for subcutaneous implantable cardioverter defibrillator (S-ICD) implantation involves three incisions and a subcutaneous (SC) pocket. An intermuscular (IM) 2-incision technique has been recently adopted. Aims: We assessed acute defibrillation efficacy (DE) of S-ICD (DE ≤65 J) according to the implantation technique. Methods: We analyzed consecutive patients who underwent S-ICD implantation and DE testing at 53 Italian centers. Regression analysis was used to determine the association between DFT and implantation technique. Results: A total of 805 patients were enrolled. Four groups were assessed: IM + 2 incisions (n = 546), SC + 2 incisions (n = 133), SC + 3 incisions (n = 111), and IM + 3 incisions (n = 15). DE was ≤65 J in 782 (97.1%) patients. Patients with DE ≤65 J showed a trend towards lower body mass index (25.1 vs. 26.5; p = .12), were less frequently on antiarrhythmic drugs (13% vs. 26%; p = .06) and more commonly underwent implantation with the 2-incision technique (85% vs. 70%; p = .04). The IM + 2-incision technique showed the lowest defibrillation failure rate (2.2%) and shock impedance (66 Ohm, interquartile range: 57-77). On multivariate analysis, the 2-incision technique was associated with a lower incidence of shock failure (hazard ratio: 0.305; 95% confidence interval: 0.102-0.907; p = .033). Shock impedance was lower with the IM than with the SC approach (66 vs. 70 Ohm p = .002) and with the 2-incision than the 3-incision technique (67 vs. 72 Ohm; p = .006). Conclusions: In a large population of S-ICD patients, we observed a high defibrillation success rate. The IM + 2-incision technique provides lower shock impedance and a higher likelihood of successful defibrillation

    Physical activity measured by implanted devices predicts atrial arrhythmias and patient outcome: Results of IMPLANTED (Italian Multicentre Observational Registry on Patients With Implantable Devices Remotely Monitored)

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    Background--To determine whether daily physical activity (PA), as measured by implanted devices (through accelerometer sensor), was related to the risk of developing atrial arrhythmias during long-term follow-up in a population of heart failure (HF) patients with an implantable cardioverter defibrillator (ICD). Methods and Results--The study population was divided into 2 equally sized groups (PA cutoff point: 3.5 h/d) according to their mean daily PA recorded by the device during the 30- to 60-day period post-ICD implantation. Propensity score matching was used to compare 2 equally sized cohorts with similar characteristics between lower and higher activity patients. The primary end point was time free from the first atrial high-rate episode (AHRE) of duration 656 minutes. Secondary end points were: first AHRE 656 hours, first AHRE 6548 hours, and a combined end point of death or HF hospitalization. Data from 770 patients (65\ub115 years; 66% men; left ventricular ejection fraction 35\ub112%) remotely monitored for a median of 25 months were analyzed. A PA =3.5 h/d was associated with a 38% relative reduction in the risk of AHRE 656 minutes (72-month cumulative survival: 75.0% versus 68.1%; log rank P=0.025), and with a reduction in the risk of AHRE 656 hours, AHRE 6548 hours, and the combined end point of death or HF hospitalization (all P < 0.05). Conclusions--In HF patients with ICD, a low level of daily PA was associated with a higher risk of atrial arrhythmias, regardless of the patients' baseline characteristics. In addition, a lower daily PA predicted death or HF hospitalization

    Telecardiology and Remote Monitoring of Implanted Electrical Devices: The Potential for Fresh Clinical Care Perspectives

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    Telecardiology may help confront the growing burden of monitoring the reliability of implantable defibrillators/pacemakers. Herein, we suggest that the evolving capabilities of implanted devices to monitor patients’ status (heart rhythm, fluid overload, right ventricular pressure, oximetry, etc.) may imply a shift from strictly device-centered follow-up to perspectives centered on the patient (and patient-device interactions). Such approaches could provide improvements in health care delivery and clinical outcomes, especially in the field of heart failure. Major professional, policy, and ethical issues will have to be overcome to enable real-world implementation. This challenge may be relevant for the evolution of our health care systems
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