Multicentre experience with the second-generation subcutaneous implantable cardioverter defibrillator and the intermuscular two-incision implantation technique.

INTRODUCTION: The recently developed second-generation subcutaneous implantable cardioverter defibrillator (S-ICD) and the intermuscular two-incision implantation technique demonstrate potential favorable features that reduce inappropriate shocks and complications. However, data concerning large patient populations are lacking. The aim of this multicentre prospective study was to evaluate the safety and outcome of second-generation S-ICD using the intermuscular two-incision technique in a large population study. METHODS AND RESULTS: The study population included 101 consecutive patients (75% male; mean age, 45 ± 13 years) who received second-generation S-ICD (EMBLEM; Boston Scientific, Marlborough, MA) implantation using the intermuscular two-incision technique as an alternative to the standard implantation technique. Twenty nine (29%) patients were implanted for secondary prevention. Twenty four (24%) patients had a previously implanted transvenous ICD. All patients were implanted without any procedure-related complications. Defibrillation testing was performed in 80 (79%) patients, and ventricular tachycardia was successfully converted at less than or equal to 65 J in 98.75% (79/80) of patients without pulse generator adjustments. During a median follow-up of 21 ± 10 months, no complications requiring surgical revision or local or systemic device-related infections were observed. Ten patients (9.9%) received appropriate and successful shocks for ventricular arrhythmias. Three (2.9%) patients experienced inappropriate shocks due to oversensing the cardiac signal (n = 1), noncardiac signal (n = 1), and a combination of both cardiac and noncardiac signals (n = 1), with one patient requiring device explantation. No patients required device explantation due to antitachycardia pacing indications. CONCLUSIONS: According to our multicentre study, second-generation S-ICD implanted with the intermuscular two-incision technique is an available safe combination and appears to be associated with a low risk of complications, such as inappropriate shocks.

Seventeen-year trend (2001-2017) in pacemaker and implantable cardioverter-defibrillator utilization based on hospital discharge database data: An analysis by age groups.

AIMS: To analyze temporal trends (2001 -2017) of Pacemakers (PM) and Implantable Cardioverter-Defibrillators (ICD) procedures in Italy, according to the national Hospital Discharge Database (HDD). METHODS: Frequency and implant rate (IR) in the Italian population were analyzed by age groups (<50, 50-79, ≥80 years). RESULTS: From 2001 (2009 for Cardiac Resynchronization Therapy-Defibrillator - CRT-D) to 2017, first PM implants (1stPM) increased from 36,823 (637/million inhabitants) to 49,716 (820/million), ICD implants from 3,141 (54/million) to 24,255 (400/million) and CRT-D from 2,915 (49/million, 16.5% of ICD) to 8,595 (142/million, 35.4% of ICD). ICD implants due to ventricular tachycardia or ventricular fibrillation decreased from 55.6% to 13.5% and from 15.9% to 4.5% respectively, while the proportion increased among patients with heart failure (from 22.9% to 46.8%), hypertension (from 11.1% to 15.0%), diabetes (from 6.5% to 10.9%), and renal insufficiency (from 4.4% to 7.6%). Both PM and ICD procedures markedly increased in patients ≥80 years old. However, while IR for ICDs increased from 82/million to 1,038/million inhabitants, IR of 1stPM only changed from 6,111/million to 6,212/million as the population in this age group nearly doubled in Italy. CONCLUSION: Since 2001, the increase of 1stPM in Italy was mainly due to the ultra-octogenarian population growth. No differences were observed for IR in each PM age group, while the absolute number and IR increased in all groups (especially ≥80 years old) for ICDs and CRT-Ds. An increase in comorbidities and a reduction in implants for secondary prevention were observed in the ICD population.

Long-term patient satisfaction with implanted device remote monitoring: a comparison among different systems.

AIMS: Remote monitoring is an effective strategy to improve patients' outcomes and reduce hospitalization in patients with cardiac implantable electronic devices. However, data on patients' satisfaction are scarce. The aim of the current study was to assess patients' satisfaction, ease of use and impact on daily activities of the remote monitoring and to investigate whether there are differences among different devices and different manufacturers. METHODS: A modified Home Monitoring Acceptance and Satisfaction Questionnaire telephone survey on the perceived quality of the different systems was performed with all patients followed with remote monitoring for at least 3 months. RESULTS: Among 604 patients with remote monitoring screened by telephone, 466 patients (77%) answered the questionnaire [142 patients (30.5%) had a pacemaker, 317 patients (68%) had an implantable cardioverter defibrillator, and seven patients (1.5%) had an implantable loop recorder]. Ninety-seven percent of patients were satisfied by the remote monitoring system during the entire follow-up and found it easy to use. Similarly, 85% of patients did not experience any restriction in daily activities, and for 99% of patients it did not affect their privacy. Importantly, for the vast majority of patients, remote monitoring gave a great (56.7%) or moderate (33.4%) sense of security. CONCLUSION: Daily impact of cardiac implantable electronic devices still remains a challenging issue for caregivers. The introduction of remote monitoring allowed closer follow-up and improved outcomes. Our results highlighted patients' satisfaction, who also felt safer, with the remote monitoring, its ease of use, and the absence of any disturbances in patients' everyday activities or in their privacy.

Intermittent levosimendan infusions in advanced heart failure: a real world experience.

Objective To analyse the effects of levosimendan infusions in advanced heart failure. Methods Patients with advanced heart failure treated with repeated levosimendan infusions were retrospectively compared with controls. Clinical, blood and echocardiographic parameters were obtained at baseline and after 12 months, and before and after each levosimendan infusion. Hospitalizations for heart failure and in-hospital length of stay in the 6 months before enrolment and after 6 and 12 months were recorded, along with 1-year mortality. Results Twenty-five patients treated with levosimendan and 25 controls were studied. After each levosimendan infusion, ventricular function and various clinical and metabolic parameters were improved. After 12 months, left ventricular ejection fraction (LVEF) had improved compared with baseline in the levosimendan group. The 1-year mortality rate was similar in both groups. During the 6 months before enrolment, hospitalizations were fewer in controls compared with the levosimendan group; after 6 and 12 months they increased in controls and decreased in the levosimendan group. Seven patients were super-responders to levosimendan, with LVEF improving more than 20% and hospitalizations being reduced at 12 months compared with the rest of the levosimendan group. Conclusion Intermittent levosimendan improved LVEF and decreased hospitalizations in advanced heart failure and represents a therapeutic option for patients whose disease is worsening.