Longevity of implantable cardioverter-defibrillators: implications for clinical practice and health care systems

n/

Use of Diltiazem in Chronic Rate Control for Atrial Fibrillation: A Prospective Case-Control Study

Atrial fibrillation (AF) is a multifaceted disease requiring personalised treatment. The aim of our study was to explore the prognostic impact of a patient-specific therapy (PT) for rate control, including the use of non-dihydropyridine calcium channel blockers (NDDC) in patients with heart failure (HF) or in combination with beta-blockers (BB), compared to standard rate control therapy (ST), as defined by previous ESC guidelines. This is a single-centre prospective observational registry on AF patients who were followed by our University Hospital. We included 1112 patients on an exclusive rate control treatment. The PT group consisted of 125 (11.2%) patients, 93/125 (74.4%) of whom were prescribed BB + NDCC (±digoxin), while 85/125 (68.0%) were HF patients who were prescribed NDCC, which was diltiazem in all cases. The patients treated with a PT showed no difference in one-year overall survival compared to those with an ST. Notably, the patients with HF in ST had a worse prognosis (p < 0.001). To better define this finding, we performed three sensitivity analyses by matching each patient in the PT subgroups with three subjects from the ST cohort, showing an improved one-year survival of the HF patients treated with PT (p = 0.039). Our results suggest a potential outcome benefit of NDCC for rate control in AF patients, either alone or in combination with BB and in selected patients with HF

Wearable Cardioverter Defibrillator (WCD) in Italy: results from the nationwide multicenter registry WEAR-ITA

Abstract Funding Acknowledgements Type of funding sources: None. BACKGROUND The Wearable Cardioverter Defibrillators (WCD) has been used extensively in Italy since 2015, following long years of experience in other countries. This technology provides temporary protection from Sudden Cardiac Death (SCD) for patients with an evolving risk profile that may not yet be eligible for an Implantable Cardioverter Defibrillator (ICD). Collecting national data on use of the device can help build a picture that will enable an understanding on how to use the WCD appropriately in the future. PURPOSE Our purpose has been to investigate WCD usage on a nationwide level. This is in terms of target population, average wear time, patient compliance, diagnosed and treated arrhythmic events and patient outcome once they stopped wearing the device. METHODS WEAR-ITA is a nationwide, multi-centre retrospective observational project. Patient data was retrospectively collected from the Italian hospitals that agreed to take part in the data collection for all patients fitted with a WCD between April 2015 to May 2018. All data refers to the range from the first day of wear until the end of use. RESULTS We collected data for 411 patients from 15 (75%) Italian regions. WCD use among the different regions was heterogeneous with a median of 0.5 (0.2-1.2) WCD wore/105 inhabitants. The mean age of the population was 55(±14) and the majority of patients were male (79%). Main WCD indication was non-ischemic cardiomyopathy with reduced ejection fraction (51%), ischemic etiology with severe systolic dysfunction (31%), uncertain or unidentified diagnosis (10%) that then revealed to be predominantly channelopathies or myocarditis and after ICD extraction (8%). Patients wore the WCD for a median of 59 (33-90) days and the median daily weartime was 23 (22,7-23,8) hours. In 15 patients (4%), the WCD recorded non sustained ventricular tachycardia (VT), 10 patients (2%) had hemodynamically well-tolerated sustained VT not needing a shock. 8 patients (2%) received effective appropriate shocks. Time to episodes were respectively 61 (14-61) days for non-sustained VT and 28 (19-70) days for VT/VF. 2 patients (0.5%) received inappropriate shocks for sinus tachycardia and atrial fibrillation (AF) respectively. WCD recorded new onset of supra ventricular tachycardia episodes in 12 patients (3%) and of atrial fibrillation (AF) in 7 patients (2%). 7 patients (2%) died while wearing WCD; none of them from SCD. At the end of the WCD use, 195 patients (47%) did not receive an ICD while 209 patients (51%)were implanted. CONCLUSIONS WCD is an effective therapy for the treatment of SCD with a very low complication rates. The indication and penetration in Italy is quite heterogeneous. The patient's compliance is high over time. The incidence of appropriate shock is not negligible; only half of patients, who wore WCD, received an ICD. There is however still a requirement to conduct further randomized trials to understand which patients could most benefit from the use of WCD. Abstract Figure. Wereable Cardioverter Defibrillato

Cardiac resynchronization therapy: a comparison among left ventricular bipolar, quadripolar and active fixation leads

We evaluated the performance of 3 different left ventricular leads (LV) for resynchronization therapy: bipolar (BL), quadripolar (QL) and active fixation leads (AFL). We enrolled 290 consecutive CRTD candidates implanted with BL (n = 136) or QL (n = 97) or AFL (n = 57). Over a minimum 10 months follow-up, we assessed: (a) composite technical endpoint (TE) (phrenic nerve stimulation at 8 [email protected] ms, safety margin between myocardial and phrenic threshold <2V, LV dislodgement and failure to achieve the target pacing site), (b) composite clinical endpoint (CE) (death, hospitalization for heart failure, heart transplantation, lead extraction for infection), (c) reverse remodeling (RR) (reduction of end systolic volume >15%). Baseline characteristics of the 3 groups were similar. At follow-up the incidence of TE was 36.3%, 14.3% and 19.9% in BL, AFL and QL, respectively (p < 0.01). Moreover, the incidence of RR was 56%, 64% and 68% in BL, AFL and QL respectively (p = 0.02). There were no significant differences in CE (p = 0.380). On a multivariable analysis, “non-BL leads” was the single predictor of an improved clinical outcome. QL and AFL are superior to conventional BL by enhancing pacing of the target site: AFL through prevention of lead dislodgement while QL through improved management of phrenic nerve stimulation

Cardiolaminopathies from bench to bedside: challenges in clinical decision-making with focus on arrhythmia-related outcomes

Lamin A/C gene mutations can be associated with cardiac diseases, usually referred to as 'cardiolaminopathies' characterized by arrhythmic disorders and/or left ventricular or biventricular dysfunction up to an overt picture of heart failure. The phenotypic cardiac manifestations of laminopathies are frequently mixed in complex clinical patterns and specifically may include bradyarrhythmias (sinus node disease or atrioventricular blocks), atrial arrhythmias (atrial fibrillation, atrial flutter, atrial standstill), ventricular tachyarrhythmias and heart failure of variable degrees of severity. Family history, physical examination, laboratory findings (specifically serum creatine phosphokinase values) and ECG findings are often important 'red flags' in diagnosing a 'cardiolaminopathy'. Sudden arrhythmic death, thromboembolic events or stroke and severe heart failure requiring heart transplantation are the most dramatic complications of the evolution of cardiolaminopathies and appropriate risk stratification is clinically needed combined with clinical follow-up. Treatment with cardiac electrical implantable devices is indicated in case of bradyarrhythmias (implant of a device with pacemaker functions), risk of life-threatening ventricular tachyarrhythmias (implant of an ICD) or in case of heart failure with wide QRS interval (implant of a device for cardiac resynchronization). New technologies introduced in the last 5 years can help physicians to reduce device-related complications, thanks to the extension of device longevity and availability of leadless pacemakers or defibrillators, to be implanted in appropriately selected patients. An improved knowledge of the complex pathophysiological pathways involved in cardiolaminopathies and in the determinants of their progression to more severe forms will help to improve clinical management and to better target pharmacological and non-pharmacological treatments

Slow VT treatment in a contemporary population of primary prevention ICD recipients

Abstract Funding Acknowledgements Type of funding sources: None. Background Implantable cardioverter defibrillator (ICD) is an effective therapy for sudden cardiac death (SCD). 2015 HRS/EHRA/APHRS/SOLAECE expert consensus document suggests long VT detection, above 185 bpm, as optimal ICD programming to reduce unnecessary therapies in primary prevention (PP). Purpose The aim of our study is to evaluate incidence, safety and efficacy of ICD treatment for VT arrhythmias below 185 bpm, in a contemporary population of PP ICD recipients with long detection intervals (LDI), morphological discrimination algorithm and antitachycardia pacing therapies (ATP) before shock. Methods We conducted a single centre retrospective study enrolling 236 patients implanted with a primary-prevention indication from January 2013 to June 2019. Patients were implanted with single or dual chamber single-lead transvenous ICD. All patients had standard device setting with long (at least 20 s in VT and 7 s in VF) VT/VF detection above 150 bpm and therapies starting from 171 with up to 5 ATP and multiple shocks. PainFREE-like bursts and Schaumann-like ramps ATP were always set in VT zone. Of each patient we collected a detailed report of up to five appropriate events and three inappropriate events. Arrhythmia diagnosis was confirmed from 3 independent expert physicians. Date of the event, cycle length, type of morphology (polymorphic or monomorphic), therapies with their effect were collected. Results During a mean follow-up of 42 months, 47 (20 %) and 18 (8%) patients had at least one appropriate and inappropriate activation, respectively. The detailed-events analysis shows that 16 (7%) patients had 38 (30%) appropriate events with rate <188 bpm. At these rate ATP were 97% effective. 14 (38%) of inappropriate activations were caused by arrythmias with ventricular rate below 188 bpm and half of these received a shock; 30% of inappropriate shocks were due to arrhythmia with rate <188 bpm. 73% of treated events, with rate <188 bpm, were appropriate. Only 5.6% (n = 10) of ATP attempts cause arrhythmia acceleration. Conclusions One third of detected arrhythmias had a rate below 188 bpm and 73% were true VT. In this slow VT zone, ATP had a high success rate with low percentage of acceleration

Exercise stress echocardiography is superior to rest echocardiography in predicting left ventricular reverse remodelling and functional improvement after cardiac resynchronization therapy

n/

The Challenges of Diagnosis and Treatment of Arrhythmogenic Cardiomyopathy: Are We there yet?

Background: we sought to review the evolution in the diagnosis and treatment of Arrhythmogenic Cardiomyopathy (ACM), a clinically multifaceted entity beyond the observation of ventricular arrhythmias, and the outcome of therapies aiming at sudden death prevention in a single center experience. Methods: retrospective analysis of the data of consecutive patients with an implanted cardioverter-defibrillator (ICD) and a confirmed diagnosis of ACM according to the proposed Padua Criteria, who were referred to our center from January 1992 to October 2021. Results: we enrolled 72 patients (66% males, mean age at implant 46 ± 16 years), 63.9% implanted for primary prevention. At the time of ICD implant, 29 (40.3%) patients had a right ventricular involvement, 24 (33.3%) had a dominant LV involvement and 19 (26.4%) had a biventricular involvement. After a median follow-up of 6,1 years [IQR: 2.5–9.9], 34 patients (47.2%) had 919 sustained episodes of ventricular arrhythmias (VA). 27 patients (37.5%) had 314 episodes of life-threatening arrhythmias (LT-VA), defined as sustained ventricular tachycardia ≥200 beats/min. Considering only the patients with an ICD capable of delivering ATP, 80.4% of VA and 65% of LT-VA were successfully terminated with ATP. 16 (22.2%) patients had an inappropriate ICD activation, mostly caused by atrial fibrillation, while in 9 patients (12.5%) there was a complication needing reintervention (in 3 cases there was a loss of ventricular sensing dictating lead revision). During the follow-up 11 (15.3%) patients died, most of them due to heart failure, and 8 (11.1%) underwent heart transplantation. Conclusions: ACM is increasingly diagnosed owing to heightened suspicion at ECG examination and to improved imaging technology and availability, though the diagnostic workflow is particularly challenging in the earliest disease stages. ICD therapy is the cornerstone of sudden death prevention, albeit its efficacy is not based on controlled studies, and VT ablation/medical therapy are complementary to this strategy. The high burden of ATP-terminated VA makes shock-only devices debatable. The progressive nature of ACM leads to severe biventricular enlargement and refractory heart failure, which pose significant treatment issues when a predominant RV dysfunction occurs owing to the reduced possibility for mechanical circulatory assistance

Is Less Always More? A Prospective Two-Centre Study Addressing Clinical Outcomes in Leadless versus Transvenous Single-Chamber Pacemaker Recipients

(1) Background: Leadless (LL) stimulation is perceived to lower surgical, vascular, and lead-related complications compared to transvenous (TV) pacemakers, yet controlled studies are lacking and real-life experience is non-conclusive. (2) Aim: To prospectively analyse survival and complication rates in leadless versus transvenous VVIR pacemakers. (3) Methods: Prospective analysis of mortality and complications in 344 consecutive VVIR TV and LL pacemaker recipients between June 2015 and May 2021. Indications for VVIR pacing were “slow” AF, atrio-ventricular block in AF or in sinus rhythm in bedridden cognitively impaired patients. LL indication was based on individualised clinical judgement. (4) Results: 72 patients received LL and 272 TV VVIR pacemakers. LL pacemaker indications included ongoing/expected chronic haemodialysis, superior venous access issues, active lifestyle with low pacing percentage expected, frailty causing high bleeding/infectious risk, previous valvular endocarditis, or device infection requiring extraction. No significant difference in the overall acute and long-term complication rate was observed between LL and TV cohorts, with greater mortality occurring in TV due to selection of older patients. (5) Conclusions: Given the low complication rate and life expectancy in this contemporary VVIR cohort, extending LL indications to all VVIR candidates is unlikely to provide clear-cut benefits. Considering the higher costs of LL technology, careful patient selection is mandatory for LL PMs to become advantageous, i.e., in the presence of vascular access issues, high bleeding/infectious risk, and long life expectancy, rendering lead-related issues and repeated surgery relevant in the long-term perspective

Usefulness of the maggic score in predicting the competing risk of non-sudden death in heart failure patients receiving an implantable cardioverter-defibrillator: A sub-analysis of the observo-icd registry

The role of prognostic risk scores in predicting the competing risk of non-sudden death in heart failure patients with reduced ejection fraction (HFrEF) receiving an implantable cardioverterdefibrillator (ICD) is unclear. To this goal, we evaluated the accuracy and usefulness of the MetaAnalysis Global Group in Chronic Heart Failure (MAGGIC) score. The present analysis included 1089 HFrEF ICD recipients enrolled in the OBSERVO-ICD registry (NCT02735811). During a median follow-up of 36 months (1st\u20133rd IQR 25\u201348 months), 193 patients (17.7%) experienced at least one appropriate ICD therapy, and 133 patients died (12.2%) without experiencing any ICD therapy. The frequency of patients receiving ICD therapies was stable around 17\u201319% across increasing tertiles of 3-year MAGGIC probability of death, whereas non-sudden mortality increased (6.4% to 9.8% to 20.8%, p < 0.0001). Accuracy of MAGGIC score was 0.60 (95% CI, 0.56\u20130.64) for the overall outcome, 0.53 (95% CI, 0.49\u20130.57) for ICD therapies and 0.65 (95% CI, 0.60\u20130.70) for non-sudden death. In patients with higher 3-year MAGGIC probability of death, the increase in the competing risk of non-sudden death during follow-up was greater than that of receiving an appropriate ICD therapy. Results were unaffected when analysis was limited to ICD shocks only. The MAGGIC risk score proved accurate and useful in predicting the competing risk of non-sudden death in HFrEF ICD recipients. Estimation of mortality risk should be taken into greater consideration at the time of ICD implantation