Search

At the beginning of the COVID-19 emergency, non-urgent surgical procedures had to be deferred, but also emergencies were reduced. To assess the global trend of pacemaker (PM) and implantable cardiac-defibrillator (ICD) procedures performed in Italy before, during, and after the first COVID-19 emergency, all the Italian hospital discharge records related to PM/ICD procedures performed between 2012 and 2021, sent to the National Institute of Health, were reviewed. Compared to 2019, in 2020, there was a reduction of first PM implants (52,216 to 43,962, -16%; p < 0.01), but not replacements (16,591 to 17,331, + 4%; p = 0.16). In particular, in April 2020, there was a drop of first implants (- 53,4% vs the average value of April 2018 and April 2019; p < 0.01), while the reduction of replacements was less evident (-32.6%; p = NS). In 2021, PM procedures increased to values similar to the pre-pandemic period. A reduction of ICD procedures was observed in 2020 (22,355, -7% toward 2019), mainly in April 2020 (- 46% vs April 2018/April 2019; p = 0.03). In 2021, the rate of ICD procedures increased (+ 14% toward 2020). A non-significant reduction of "urgent" procedures (complete atrioventricular block for PM and ventricular fibrillation for ICD), even in April 2020, was observed. In 2020, there was a reduction of first PM implants and ICDs, offset by increased activity in 2021. No decrease in PM replacements was observed, and the drop in "urgent" PM and ICD procedures was not statistically significant., (© 2023. The Author(s).)

Background: The Pacemaker (PM) and Implantable Cardioverter-Defibrillator (ICD) Registry of the Italian Association of Arrhythmology and Cardiac Pacing (AIAC) collects information about demographics, clinical characteristics, main indications for PM/ICD therapy and device types from the voluntary Italian collaborating centers., Methods: For the year 2021 main data about national PM and ICD implantation activity were obtained on the basis of European Cards and subsequently analyzed to create a standard report., Results: PM Registry: data about 18 631 PM implantations were collected (15879 first implants and 2752 replacements). The number of collaborating centers was 121. Median age of treated patients was 82 years (76 quartile I; 87 quartile III). Main ECG indications included atrioventricular conduction disorders in 26.8% of first PM implants, sick sinus syndrome in 12.2%, atrial fibrillation plus bradycardia in 9.6%, other unspecified ECG and electrophysiological abnormalities in 43.0%. For first PM implants, pacing in DDDR mode was reported in 46.5%, followed by DDD mode (20.6%), VVIR mode (15.0%), VVI mode (9.0%) and finally VDD-VDDR (5.8%). Median value of longevity of explanted PMs was 8.9 years. ICD Registry: data about 6878 ICD implantations were obtained (4708 first implants and 2170 replacements). The number of collaborating centers was 345. Median age of treated patients was 72 years (70 quartile I; 75 quartile III). Primary prevention indication was reported in 86.3% of first implants, secondary prevention in 13.7% (cardiac arrest in 4.4% of records). A single-chamber ICD was used in 32.1% of first implants, dual-chamber ICD in 30.3% and biventricular ICD in 37.6%. Median value of longevity of explanted ICDs was 6.9 years., Conclusions: In the calendar year 2021, the Italian PM Registry showed stable electrocardiographic and symptom indications, with an important prevalence of dual-chamber pacing. The ICD Registry documented a large use of prophylactic and biventricular ICDs, reflecting a favorable adherence in the clinical practice to trials and guidelines. The ICD longevity and the number of recalls demonstrated a favorable trend. In order to increase and optimize the cooperation of Italian PM and ICD implanting centers, the online data entry (https://www.aiac.it/riprid) should be adopted at large scale.

Background: The subsequent waves of the COVID-19 pandemic in Italy had a major impact on cardiac care., Methods: A survey to evaluate the dynamic changes in arrhythmia care during the first five waves of COVID-19 in Italy (first: March-May 2020; second: October 2020-January 2021; third: February-May 2021; fourth: June-October 2021; fifth: November 2021-February 2022) was launched., Results: A total of 127 physicians from arrhythmia centers (34% of Italian centers) took part in the survey. As compared to 2019, a reduction in 40% of elective pacemaker (PM), defibrillators (ICD), and cardiac resynchronization devices (CRT) implantations, with a 70% reduction for ablations, was reported during the first wave, with a progressive and gradual return to pre-pandemic volumes, generally during the third-fourth waves, slower for ablations. For emergency procedures (PM, ICD, CRT, and ablations), recovery from the initial 10% decline occurred in most cases during the second wave, with some variability. However, acute care for atrial fibrillation, electrical cardioversions, and evaluations for syncope showed a prolonged reduction of activity. The number of patients with devices which started remote monitoring increased by 40% during the first wave, but then the adoption of remote monitoring declined., Conclusions: The dramatic and profound derangement in arrhythmia management that characterized the first wave of the COVID-19 pandemic was followed by a progressive return to the volume of activities of the pre-pandemic periods, even if with different temporal dynamics and some heterogeneity. Remote monitoring was largely implemented during the first wave, but full implementation is needed., (© 2022. The Author(s), under exclusive licence to Società Italiana di Medicina Interna (SIMI).)

Aims: Sudden cardiac death (SCD) causes high mortality and substantial societal burdens for healthcare systems (HSs). The risk of SCD is significantly increased in patients with reduced left ventricular ejection fraction after myocardial infarction (MI). Current guidelines recommend re-evaluation of cardioverter-defibrillator implantation 40 days post-MI, earliest. Medical therapy alone does not provide sufficient protection against SCD, especially in the first month post-MI, and needs time. Consequently, there is a gap in care of high-risk patients upon hospital discharge. The wearable cardioverter defibrillator (WCD) is a proven safe, effective therapy, which temporarily protects from SCD. Little information on WCD cost-effectiveness exists. We conducted this research to demonstrate the medical need of the device in the post-MI setting defining WCD cost-effectiveness., Methods & Results: Based on a randomized clinical trials (RCTs) and Italian and international data, we developed a Markov-model comparing costs, patient survival, and quality-of-life, and calculated the Incremental Cost-Effectiveness Ratio (ICER) of a WCD vs. current standard of care in post-MI patients. The rather conservative base case analysis - based on the RCT intention-to-treat results - produced an ICER of €47,709 per Quality Adjusted Life Year (QALY) gained, which is far lower than the accepted threshold of €60,000 in the Italian National HS. The ICER per Life Year (LY) gained was €38,276., Conclusion: WCD utilization in post-MI patients is clinically beneficial and cost-effective. While improving guideline directed patient care, the WCD can also contribute to a more efficient use of resources in the Italian HS, and potentially other HSs as well., (Copyright © 2022 Elsevier B.V. All rights reserved.)

Background: The Pacemaker (PM) and Implantable Cardioverter-Defibrillator (ICD) Registry of the Italian Association of Arrhythmology and Cardiac Pacing (AIAC) collects information about demographics, clinical characteristics, main indications for PM/ICD therapy and device types from the Italian collaborating centers., Methods: For the year 2020, the main data about national PM and ICD implantation activity were obtained on the basis of European Cards and subsequently analyzed to create a standard report., Results: PM Registry: data about 22 080 PM implantations were collected (18 027 first implants and 3803 replacements). The number of collaborating centers was 142. Median age of treated patients was 82 years (75 quartile I; 87 quartile III). ECG indications included atrioventricular conduction disorders in 31.0% of first PM implants, sick sinus syndrome in 13.8%, atrial fibrillation plus bradycardia in 9.9%, other unspecified ECG and electrophysiological abnormalities in 36.6%. Use of single-chamber PMs was reported in 29.0% of first implants, of dual-chamber PMs in 68.2%, of PM with cardiac resynchronization therapy (CRT) in 2.7%. ICD Registry: data about 11 931 ICD implantations were obtained (8266 first implants and 3665 replacements). The number of collaborating centers was 330. Median age of treated patients was 72 years [63 quartile I; 79 quartile III]. Primary prevention indication was reported in 85.0% of first implants, secondary prevention in 15.0% (cardiac arrest in 4.2%). A single-chamber ICD was used in 30.2% of first implants, dual-chamber ICD in 31.2% and biventricular ICD in 38.6%., Conclusions: In the calendar year 2020, the Italian PM Registry showed stable ECG and symptom indications, with an important prevalence of dual-chamber pacing. The ICD Registry documented a large use of prophylactic and biventricular ICDs, reflecting a favorable adherence in clinical practice to trials and guidelines. The ICD longevity and the number of recalls demonstrated a favorable trend. In order to increase and optimize the cooperation of Italian PM and ICD implanting centers, the online data entry (https://www.aiac.it/riprid) should be adopted at large scale.

Aims: Patients with permanently increased risk of sudden cardiac death (SCD) can be protected by implantable cardioverter defibrillators (ICD). If an ICD must be removed due to infection, for example, immediate reimplantation might not be possible or indicated. The wearable cardioverter defibrillator (WCD) is an established, safe and effective solution to protect patients from SCD during this high-risk bridging period. Very few economic evaluations on WCD use are currently available., Methods: We conducted a systematic review to evaluate the available evidence of WCD in patients undergoing ICD explant/lead extraction. Additionally, a decision model was developed to compare use and costs of the WCD with standard therapy (in-hospital stay). For this purpose, a cost-minimization analysis was conducted, and complemented by a one-way sensitivity analysis., Results: In the base case scenario, the WCD was less expensive compared to standard therapy. The cost-minimization analysis showed a cost reduction of €1782 per patient using the WCD. If costs of standard care were changed, cost savings associated with the WCD varied from €3500 to €0, assuming costs for standard care of €6800 to €3600., Conclusion: After ICD explantation, patients can be safely and effectively protected from SCD after hospital discharge through WCD utilization. Furthermore, the use of a WCD for this patient group is cost saving when compared to standard therapy., (© 2021 The Authors. Clinical Cardiology published by Wiley Periodicals LLC.)

Background: The pacemaker (PM) and implantable cardioverter-defibrillator (ICD) Registry of the Italian Association of Arrhythmology and Cardiac Pacing (AIAC) monitors the main epidemiological data in real-world practice. The survey for the 2019 activity collects information about demographics, clinical characteristics, main indications for PM/ICD therapy and device types from the Italian collaborating centers., Methods: The Registry collects prospectively national PM and ICD implantation activity on the basis of European cards., Results: PM Registry: data about 22 889 PM implantations were collected (19 621 first implants and 3268 replacements). The number of collaborating centers was 173. Median age of treated patients was 81 years (75 quartile I; 87 quartile III). ECG indications included atrioventricular conduction disorders in 33.3% of first PM implants, sick sinus syndrome in 16.4%, atrial fibrillation plus bradycardia in 11.6%, other in 38.7%. Among atrioventricular conduction defects, third-degree atrioventricular block was the most common type (18.3% of first implants). Use of single-chamber PMs was reported in 25.5% of first implants, of dual-chamber PMs in 67.1%, of PMs with cardiac resynchronization therapy (CRT) in 1.5%, and of single lead atrial-synchronized ventricular stimulation (VDD/R PMs) in 5.8%. ICD Registry: data about 17 328 ICD implantations were collected (12 129 first implants and 5199 replacements). The number of collaborating centers was 425. Median age of treated patients was 71 years (62 quartile I; 77 quartile III). Primary prevention indication was reported in 83.1% of first implants, secondary prevention in 16.9% (cardiac arrest in 5.9%). A single-chamber ICD was used in 26.1% of first implants, dual-chamber ICD in 28.0% and biventricular ICD in 45.9%., Conclusions: The PM and ICD Registry appears fundamental for monitoring PM and ICD utilization on a large national scale with rigorous examination of demographics and clinical indications. The PM Registry showed stable electrocardiographic and symptom indications, with an important prevalence of dual-chamber pacing. The use of CRT-PM regards a very limited number of patients. The ICD Registry documented a large use of prophylactic and biventricular ICD, reflecting a favorable adherence to trials and guidelines in clinical practice. In order to increase and optimize the cooperation of Italian implanting centers, online data entry (https://www.aiac.it/riprid) should be adopted at large scale.

Sudden cardiac death is defined as a natural death due to termination of cardiac activity associated with loss of consciousness, spontaneous breathing and circulation. Nowadays, the prevention of sudden cardiac death represents a major issue and many areas of uncertainty are not met by current evidences. Among those, reliable tools for risk stratification are still lacking, as well as solution for patients in which the risk of sudden cardiac death is due to a transient or correctable condition.The concept of the wearable cardioverter defibrillator is based on a potential solution for such grey areas. It merges long-term monitoring capabilities, shockable rhythm discrimination and shock delivery without the need for bystander assistance or invasive procedures. The present review aims to summarize current problems in dealing with this insidious condition, and to discuss potential options for patients in whom sudden cardiac death could be prevented more safely and cost-effectively.

In patients with cardiac implantable electronic devices (CIEDs) (implantable cardioverter-defibrillators [ICDs] and pacemakers [PMs]), the potential risk of suddenly being unable to drive, and hence of causing road accidents, is higher than in the general population. In ICD patients, this risk stems from the possibility that an arrhythmic event leading to loss of consciousness may occur while driving. In PM patients, it may be the result of a device malfunction in a PM-dependent patient. To determine a CIED patient's ability to drive, two variables must be taken into account: (i) the risk of events, which depends on the type of underlying heart disease (ICD patients have a higher risk than PM patients); (ii) the time spent driving and the type of vehicle driven (professional drivers are at higher risk than private drivers). This position paper reports the recommendations of the Italian Association of Arrhythmology and Cardiac Pacing (AIAC) regarding driving by patients with CIEDs, on the basis of the available literature and the European reference recommendations.

Background : Few data are available regarding lead preferences of electrophysiologists during cardiac implantable electronic devices (CIEDs) implantation. Aim of this survey is to evaluate the leads used, and the reasons behind these choices, in a large population of implanters. Methods : A questionnaire was sent to all 314 Italian centers with experience in CIED implantation. Results : 103 operators from 100 centers (32% of centers) responded. For atrium, passive leads represented first choice for pacemakers and defibrillators (71% and 64% of physicians, respectively), mainly for safety. For right ventricle, active fixation was preferred (61% and 93% operators in pacemaker and defibrillator patients), for higher versatility in positioning and lower dislodgement risk. For left ventricular stimulation, quadripolar leads were preferred by more than 80% of respondents, for better phrenic nerve and myocardial threshold management; active-fixation leads represent a second choice, in order to prevent or manage dislodgement (78% and 17% of respondents, respectively), but 44% of operators considered them dangerous. Conclusions : The choice of leads is heterogeneous. Trends are toward active-fixation right ventricular leads and passive-fixation atrial leads (particularly in pacemaker patients, considered frailer). For left ventricular stimulation, operators' majority want to disposition all kind of leads, although quadripolar leads are the favorites.

Aims: The aim of this survey was to assess the management and organization of cardiac implantable electronic device (CIED) replacement in Italy., Methods: A questionnaire consisting of 24 questions on organizational aspects and on the peri-procedural management of anticoagulant therapies and antibiotic prophylaxis was sent via the Internet to 154 Italian arrhythmia centers., Results: A total of 103 out of 154 centers completed the questionnaire (67% response rate). In 43% of the centers, the procedures were performed under day-case admission, in 40% under ordinary admission, and in 17% under either day-case or ordinary admission. The most frequent reason (66%) for choosing ordinary admission rather than day-case admission was to obtain full reimbursement. Although warfarin therapy was continued in 73% of the centers, nonvitamin K oral anticoagulants were discontinued, without bridging, 24 h or less prior to replacement procedures in 88%. Prophylactic antibiotic therapy was systematically administered in all centers; in 97%, the first antibiotic dose was administered 1-2 h prior to procedures. Local antibacterial envelopes were also used in 43% of the centers in patients with a higher risk of device infection., Conclusion: This survey provides a representative picture of how CIED replacements are organized and managed in current Italian clinical practice. The choice of the type of hospitalization (short versus ordinary) was more often motivated by economic reasons (reimbursement of the procedure) than by clinical and organizational factors. Peri-procedural management of anticoagulation and prophylactic antibiotic therapy was consistent with current scientific evidence.

Pacemakers, cardioverter/defibrillators, and implantable loop recorders with their continuously improved diagnostic capabilities offer detailed information that can help interpreting a cardiac arrhythmia in implanted patients. Nevertheless, in some cases, analysis of the electrical signals stored in the device memory may not be easy. An accurate knowledge of the company-specific software and the meaning of the different markers used are necessary to correctly interpret the arrhythmia or diagnose an inappropriate device intervention due to under- or oversensing. This new technology does not replace the "old" surface electrocardiogram but supplements it to improve arrhythmia diagnosis., (Copyright © 2019 Elsevier Inc. All rights reserved.)