Paola Ferrari

Intermuscular pocket for subcutaneous implantable cardioverter defibrillator: Single-center experience.

The subcutaneous implantable cardioverter defibrillator (S‐ICD) is a novel device now accepted in clinical practice for treating ventricular arrhythmias. In 14 consecutive patients, S‐ICD devices were placed in the virtual space between the anterior surface of the serratus anterior muscle and the posterior surface of the latissimus dorsi muscle. During a mean follow up of 9 months, no dislocations, infections, hematoma formations, or skin erosions were observed. Intermuscular implantation of the S‐ICD could be a reliable, safe, and appealing alternative to the standard subcutaneous placement.

Effectiveness of subcutaneous implantable cardioverter-defibrillator testing in patients with hypertrophic cardiomyopathy

BACKGROUND Subcutaneous ICD (S-ICD) is a promising option for Hypertrophic Cardiomyopathy (HCM) patients at risk of Sudden Cardiac Death (SCD). However, its effectiveness in terminating ventricular arrhythmias in HCM is yet unresolved. METHODS Consecutive HCM patients referred for S-ICD implantation were prospectively enrolled. Patients underwent one or two attempts of VF induction by the programmer. Successful conversion was defined as any 65J shock that terminated VF (not requiring rescue shocks). Clinical and instrumental parameters were analyzed to study predictors of conversion failure. RESULTS Fifty HCM patients (34 males, 40±16years) with a mean BMI of 25.2±4.4kg/m2 were evaluated. Mean ESC SCD risk of was 6.5±3.9% and maximal LV wall thickness (LVMWT) was 26±6mm. In 2/50 patients no arrhythmias were inducible, while in 7 (14%) only sustained ventricular tachycardia was induced and cardioverted. In the remaining 41 (82%) patients, 73 VF episodes were induced (1 episode in 14 and >1 in 27 patients). Of these, 4 (6%) spontaneously converted. In 68/69 (98%) the S-ICD successfully cardioverted, but failed in 1 (2%) patient, who needed rescue defibrillation. This patient was severely obese (BMI 36) and LVMWT of 25mm. VF was re-induced and successfully converted by the 80J reversed polarity S-ICD. CONCLUSIONS Acute DT at 65J at the implant showed the effectiveness of S-ICD in the recognition and termination of VT/VF in all HCM patients except one. Extreme LVH did not affect the performance of the device, whereas severe obesity was likely responsible for the single 65J failure.

Subcutaneous implantable cardioverter defibrillator eligibility according to a novel automated screening tool and agreement with the standard manual electrocardiographic morphology tool

PurposeSince subcutaneous implantable cardioverter defibrillator (S-ICD) introduction, the pre-implant screening based on a dedicated manual ECG tool (MST) was required to assure adequate sensing by the S-ICD. A novel automated screening tool (AST) has been recently developed. We assessed and compared the pass rate with AST and MST, and we measured the agreement between screening tools.MethodsThree electrodes were positioned at locations mimicking the placement of the S-ICD, and ECG recordings were collected in the supine and standing postures at rest. The three sensing vectors were analyzed with the MST and the AST. Eligibility was defined by the presence of at least one or two appropriate vectors in both postures.ResultsA total of 235 patients with an indication to ICD and no need for permanent pacing were enrolled. At least one suitable vector was identified in 214 (91%) patients with MST and 221 (94%) patients with AST (p = 0.219). At least two vectors were appropriate in 162 (69%) patients with MST and 187 (80%) patients with AST (p = 0.008). Overall, out of 1587 ECG analyzed, 1035 (65%) qualifying leads were identified with MST and 1111 (70%) with AST (p = 0.004). The agreement between the results of MST and AST ECG analysis was moderate (Kappa = 0.570; standard error = 0.022; CI = 0.526–0.613). The results were consistent regardless of the underlying cardiomyopathy. The most frequent reason for screening failure with MST was a high-amplitude T-wave (31% of failures). With AST, 23% of recordings that failed with MST for high-amplitude T-wave were classified as acceptable.ConclusionThe AST is associated with higher pass rate than the standard MST. It seems more tolerant of high-amplitude T-waves. Consequently, the agreement between MST and AST findings was only moderate.

External closed-circuit cooling system for management of patients after device implantation: A feasibility study

BACKGROUND In the first 24h after pacemaker or implantable cardioverter/defibrillator (ICD) implantation or replacement, the occurrence of hematoma and pain in the surgically treated region is not infrequent and may result in re-intervention and/or more severe complications, such as infections. Currently, the post-implant phase management is very empiric. The aim of this study was to test the clinical applicability and usefulness of an external close-circuit cooling system for the management of the early post-implant period in patients with high risk of hematoma due to anticoagulant and/or antiplatelet therapy. METHODS We studied 135 patients (78M; 71±11years) with high risk of hematoma occurrence after pace-maker (63 patients) or ICD (72 patients) implantation or replacement. Immediately after the intervention, a closed-circuit cooling system (CAREPACE™ system, Zamar, Italy) was externally applied on the pre-pectoral region to each patient and maintained for 24h. The system has a compressive pad and a refrigerating circuit in which non-toxic glycolic fluid is pumped. The fluid temperature was set and kept at 5°C for the whole period. RESULTS The compressive and cooling effect of the system was well tolerated by all the patients at the temperature set. Four patients complained of noise due to machine operation, but in none the treatment was interrupted. The average length of hospital stay was 2.8±0.4days. No clinically significant hematoma was observed at discharge and after one month follow-up visit. CONCLUSIONS This new system can be used for the management of the early phase after device implantation or replacement and appears clinically useful and well tolerated. Further studies on a larger scale are needed to test the potential reduction of post-intervention complications and the cost-effectiveness of this device.

Strategy to identify subjects with diabetes mellitus more suitable for selective echocardiographic screening: The DAVID-Berg study

BACKGROUND Despite the burden of pre-clinical heart failure (HF) among diabetes mellitus (DM) patients, routine screening echocardiography is not currently recommended. We prospectively assessed risk prediction for HF/death of a screening strategy combining clinical data, electrocardiogram, NTproBNP, and echocardiogram, aiming to identify DM patients more suitable for selective echocardiography. METHODS Among 4047 screened subjects aged≥55/≤80years, the DAVID-Berg Study prospectively enrolled 623 outpatients with DM, or hypertension, or known cardiovascular disease but with no HF history/symptoms. The present analysis focuses on data obtained during a longitudinal follow-up of the 219 patients with DM. RESULTS Mean age was 68years, 61% were men, and median DM duration was 4.9years. During a median follow-up of 5.2years, 50 subjects developed HF or died. A predictive model using clinical data demonstrated moderate predictive power, which significantly improved by adding electrocardiogram (C-statistic 0.75 versus 0.70; p<0.05), but not NTproBNP (C-statistic 0.72, p=0.20). Subjects with normal clinical variables or abnormal clinical variables but normal electrocardiogram had low events rate (1.3 versus 2.4events/100-person-years, p=NS). Conversely, subjects with both clinical and electrocardiogram abnormalities (47%) carried higher risk (9.0events/100-person-years, p<0.001). The predictive power for mortality/HF development increased when echocardiography was added (13.6events/100-person-years, C-statistic 0.80, p<0.05). CONCLUSIONS Our prospective study found that a selective echocardiographic screening strategy guided by abnormal clinical/electrocardiogram data can reliably identify DM subjects at higher risk for incident HF and death. This screening approach may hold promise in guiding HF prevention efforts among DM patients.

Cavotricuspid isthmus ablation and subcutaneous monitoring device implantation in a 2-year-old baby with 2 SCN5A mutations, sinus node dysfunction, atrial flutter recurrences, and drug induced long-QT syndrome: a tricky case of pediatric overlap syndrome?

We describe the case of 2‐year‐old baby with compound heterozygosity for paternal and maternal alleles mutation of α‐subunit of the cardiac sodium channel (SCN5A), sinus node dysfunction, atrial flutter recurrences, and drug induced long‐QT syndrome. In this setting, we chose at first to perform linear ablation of cavotricuspid isthmus resulting in a bidirectional isthmus block. As a second step, we decided to implant a miniaturized loop recorder that, with a minimally invasive procedure, permits us to follow the development of the disease in order to define the future strategy. After 8 months follow‐up, automatic daily loop‐recorder transmissions disclose the complete absence of any arrhythmia along with asymptomatic ventricular pauses due to sinus node dysfunction. Echocardiography shows normal findings, in particular no left ventricular dysfunction.

Transvenous pacing in pediatric patients with bipolar lumenless lead: Ten-year clinical experience

INTRODUCTION A number of challenges can affect long-term performance of endocardial implanted systems in pediatric patients. Select Secure™ lead offers potential advantages for this population. This analysis aims to evaluate long-term performance of this lead in children, with and without congenital heart disease. METHODS A retrospective analysis of all patients younger than 16years, implanted with at least one Select Secure™ lead at our institution, was performed. Clinical patient characteristics, electrical lead parameters, implant related complications, occurrence of surgical revisions and other complications were analyzed. RESULTS From 2006 to 2016, 40 pediatric patients (26 males; age: 10.3±4.6years) underwent a cardiac device implantation with at least one Select Secure™ lead. Axillary vein access was chosen in 77.5% of the procedures. The intra-atrial loop of the leads was successfully created and the generator was placed in a sub-pectoral pocket in all patients. A total of 57 Select Secure™ leads were implanted: 23 in the right atrium and 34 in the right ventricle. PM/ICDs implantation was uneventful in all 40 patients. One lead, dislodged the day after implantation, was successfully extracted and replaced in the same day. Adequate pacing parameters were achieved during a follow-up of 6±2.9years (range 0.9-10.8years). CONCLUSIONS In a pediatric population, the Select Secure™ lead used in the axillary vein, the creation of an intra-atrial loop and the placement of the generator in a sub-pectoral pocket ensured a safe implantation of pacemaker or ICD and an effective stimulation at medium-term follow-up.

Is mild asymptomatic left ventricular systolic dysfunction always predictive of adverse events in high-risk populations? Insights from the DAVID-Berg study: Mild asymptomatic systolic dysfunction and prognosis

Mild asymptomatic left ventricular systolic dysfunction (ALVSD) may be associated with incident heart failure (HF). However, this gray zone group needs incremental risk refinement. We hypothesized that diastolic dysfunction (DD) may refine HF and death risk prediction in mild ALVSD.