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Cardiac resynchronization therapy (CRT) using coronary sinus (CS) leads is an established therapy for congestive heart failure in patients with asynchronous ventricular contractions. CRT improves not only exercise tolerance but also the patient's prognosis. Appropriate patient selection for CRT is essential for a successful therapeutic response. Inclusion criteria are based on symptoms (New York Heart Association classes III and IV), a reduced ejection fraction, and a widened QRS complex. The presence of objective markers of heart failure can be considered a prerequisite for successful CRT. CRT procedures are much longer than regular pacemaker implantations, and thus the risk of infection may be greater. Successful therapy depends on the placement of left ventricular leads, usually via the CS, which is a technically more challenging procedure than regular pacemaker implantations. Complications specific to CRT include ventricular arrhythmia, such as ventricular tachycardia or ventricular fibrillation; total atrioventricular block or sinus arrest without any escape rhythm; and CS dissection. [ABSTRACT FROM AUTHOR]

Left bundle brunch block (LBBB) and right ventricular stimulation (RVS) may be associated with asynchrony and heart failure. Differences between these two entities and their response to cardiac resynchronization therapy (CRT) are not well defined. Patients receiving CRT from 1999 to 2006 were analyzed for cardiac events and prognosis separated between primary implants for LBBB (n = 221) and upgrades from RVS (n = 107). A subgroup of 105 patients (LBBB = 69; RVS = 36) was studied in more detail (New York Heart Association [NYHA], quality of life, brain natriuretic peptide, peakVO2, left ventricular ejection fraction [LVEF], wedge pressure, Cardiac Index, QRS, left-right preejection period using pulsed wave doppler, septum-lateral wall motion delay using tissue doppler imaging) at baseline and after 1 year. Age (68.4 ± 11 years vs 68.7 ± 15 years, n. s.), NYHA class (3.1 vs 3.1, n. s.), LVEF (26.4 vs 28.1, n. s.), and clinical parameters were comparable between LBBB and RVS. The latter group consisted of more patients with chronic atrial fibrillation (14% vs 37%, P = 0.03). After 1 year, NYHA class (-0.8 ± 0.8 vs -0.6 ± 0.8, n. s.), LVEF (+13.7 ± 14% vs +8.7 ± 10%, n. s.), and clinical parameters improved similarly. After a median follow-up of 2.33 ± 1.8 years in the LBBB versus 2.43 ± 1.9 years in the RVS group, there was no difference in long-term prognosis or cardiac events in the total cohort (5-year event rate, 53% vs 55%, P = n. s.). Upgrade patients showed similar baseline parameters and response to CRT as to primary implants. No difference in events or long-term prognosis could be observed. [ABSTRACT FROM AUTHOR]

Background: Carvedilol and at least in some studies, amiodarone have been shown to improve symptoms and prognosis of patients with heart failure. There are no reports on the outcome of combined treatment with both drugs on top of angiotensin-converting enzyme inhibitors (ACEI), diuretics and digitalis.Methods and Results: In 109 patients with severe heart failure submitted for heart transplantation at one single center between the years 1996 and 1998 [left ventricular ejection fraction (LVEF) 24.6+/-11%, 85% males, 52% idiopathic dilated cardiomyopathy (DCM), mean observation time 1. 9+/-0.4 years] a therapy with low-dose amiodarone (1000 mg/week) plus titrated doses of carvedilol (target 50 mg/day) was instituted. In addition, patients received a prophylactic dual chamber pacemaker (PM) in order to protect from bradycardia and for continuous holter monitoring. The devices were programmed in back-up mode with a basal rate of 40 i.p.m. with a hysteresis of 25%. Significantly, more patients were in sinus rhythm after 1 year than at study entry (85% vs. 63%, P<0.01). In 47 patients, under therapy over at least 1 year, the resting heart rate fell from 90+/-19 to 59+/-5 b.p.m. (P<0.001). Ventricular premature contractions in 24-h holter ECGs were suppressed from 1.0+/-3 to 0.1+/-0.3%/24 h (P167 b.p.m. detected by the pacemaker (1.2+/-2.8 episodes/patient/3 months vs. 0.3+/-0.8 episodes/patient/3 months after 1 year (P<0.01). The LVEF increased from 26+/-10 to 39+/-13% (P<0.001). NYHA class improved from 3. 17+/-0.3 to 1.8+/-0.6 (P<0.001) as well as right heart catheterization data. From the total cohort, seven patients (6%) developed symptomatic documented bradycardic rhythm disturbances requiring reprogramming of their pacemakers to DDD(R)/VVI(R) mode with higher basic rates. Two of these patients developed AV block, four sinu-atrial blocks or sinus bradycardia and one patient had bradycardic atrial fibrillation. During the observation period five patients died (3 sudden, 1 due to heart failure and 1 due to mesenteric infarction). Two patients had undergone heart transplants. The 1-year survival rate (Kaplan-Meier) without transplantation was 89%. Compared to historic control patients with amiodarone only (n=154) or without either agent (n=283) this rate was 64 and 57% (P<0.01).Conclusions: Heart failure patients benefit from a combined therapy with carvedilol and amiodarone resulting in a markedly improved NYHA stage, an increase in LV ejection fraction, a stabilization of sinus rhythm, a significant reduction in heart rate, a delay of electrical signal conduction and a suppression of ventricular ectopies. Approximately 6% of patients under such a regime became pacemaker-dependent in the first year. Compared to historic controls prognosis was better and the need for heart transplantation was lower. The exact role of either agent in combination or alone should be clarified in larger randomized studies. [ABSTRACT FROM AUTHOR]

Background Transmyocardial laser revascularization is a new therapeutic option for end-stage coronary artery disease if no other cardiological or cardiosurgical intervention is possible. Data are few on how patients fare after more than 1 year follow-up.Methods and Results From a total of 157 patients who were suggested for transmyocardial laser therapy in the years 1995–1997, 126 were judged to have non-revascularizable coronary artery disease (mean age 61·9±14 years, 80% men, mean left ventricular ejection fraction 46·2±17·1%). Sixty-six patients had a good clinical response to intensification of the antianginal therapy and were therefore treated further medically. In 60 patients with refractory angina, sole transmyocardial laser revascularization without cardiopulmonary bypass or additional grafts was performed. The transmyocardial laser revascularization group was 32% female; 78·3% patients had had bypass operations; the mean left ventricular ejection fraction was 53·6±15%. Eighty five percent of the transmyocardial laser revascularization patients had demonstrable ischaemic regions, as visualized by dipyridamol–MIBI scintigraphy. The percentage of patients with some hibernating myocardium in positron emission tomography studies was 70%. Good early relief of angina symptoms was experienced by patients who had undergone laser treatment. After 3 months the Canadian Cardiovascular Society class fell from 3·31±0·51 to 1·84±0·77 in 49 patients (P<0·0001), but increased in the total group to 2·02±0·92 after 6 months (n=47), to 2·26±0·99 after 1 year (n=42), to 2·47±1·11 after 2 years (n=38) and to 2·58±0·9 after 3 years (n=19). MIBI/positron emission tomography data at rest and after 6 months was worse in patients in whom pre- and postoperative studies were complete (n=22). The peri-operative mortality was 12% (n=7: peri-operative myocardial infarction, low output syndrome, arrhythmia). Mortality after 1 and 3 years was 23% and 30%, respectively. The risk of transmyocardial laser revascularization was significantly elevated in patients with left ventricular ejection fraction <40%. Late deaths (n=9) were due to sudden arrhythmias or pump failure. There was a high rate of cardiac events and reinterventions in the transmyocardial laser revascularization group, including percutaneous trans-luminal coronary angioplasty in newly developed lesions (n=7), valve replacement (n=2), need for intermittent urokinase therapy (n=5) and heart transplantation (n=2).Conclusion Fifty percent of patients with non-revascularizable coronary artery disease submitted for transmyocardial laser revascularization can be stabilized medically. Transmyocardial laser revascularization led to a rapid early relief of symptoms, but with a trend towards worsening over time and showed a high peri-operative risk (>10%) dependent on the pre-operative ejection fraction. Our data were in contrast to other published reports on the more beneficial effects of transmyocardial laser revascular-ization and should lead to further investigation of this experimental method. Transmyocardial laser revasculariz-ation should only be performed after failure of maximal anti-anginal therapy, and should be avoided when the left ventricular ejection fraction is <40%. [ABSTRACT FROM PUBLISHER]

Unlabelled: We describe unexpected episodes of paced tachycardia in two patients with rate-responsive pacemakers during anaesthesia. Five months after a heart transplant and implantation of a pacemaker a 43-year-old patient suffered cardiac tamponade as a result of chronic pericarditis. The second case involved embolic occlusion of the femoral artery in a 33-year-old female patient previously operated on for tricuspid valve replacement and implantation of a pacemaker. In both cases induction of anaesthesia was performed with fentanyl, etomidate and vecuronium. Following intubation and mechanical ventilation, the heart rates (HR) of the two patients increased to 140 and 130 min-1 respectively. This was interpreted as a sign of inadequate anaesthesia, and therefore additional doses of fentanyl and etomidate were given, with no effect on the tachycardia. After exclusion of other possible reasons for this complication such as hypokalaemia, hypercapnia, hypoxaemia or allergic reactions, unexpected functioning of the rate-responsive pacemakers due to thoracic impedance changes was assumed. Minute ventilation was reduced, lowering paced HR in 3-5 min.Conclusions: These case reports suggest that anaesthetic management affects the action of rate-responsive pacemakers, causing haemodynamic complications, and inadequate interventions by the anaesthesiologist. Thus, it is necessary for anaesthesiologists to make a preoperative evaluation of the underlying medical disease and the type of pacemaker in order to adjust anaesthetic management accordingly and to understand the haemodynamic responses that may occur during the perioperative period. Preoperative programming to exclude the rate-responsive function is advised. [ABSTRACT FROM AUTHOR]

Routine intraoperative transesophageal echocardiography (TEE) revealed a previously undiscovered ventricular positioning of an infected ventricular lead left in place for 10 years. This case report describes successful removal of this lead from the left ventricle by means of excimer laser and discusses some important aspects to be considered. [ABSTRACT FROM AUTHOR]

A response by S. Behrens and colleagues to a letter to the editor about their paper "Coronary Sinus Lead Fragmentation 2 Years After Implantation With a Retained Guidewire Technique," published in a previous issue of "Pacing & Clinical Electrophysiology," is presented.

Introduction Early detection of volume overload prior to clinical decompensationis crucial in the management of the heart failure patients. To reach this goal tho-racic impedance measurements generating an index with alarming functions(Optivol) are integrated in a newly released defibrillator for cardiac resynchro-nization therapy (Sentry, Medtronic Inc). Up to now there are no data on the clin-ical usefulness of these measurements. Methods From August 2004 to January 2005 Sentry devices were implanted in18 patients in our center. There were 13 man and 5 women (mean age 61±17years, mean LVEF 23±8%). Data of the Optivol-Index were interrogated from thedevices in approximately 4 week intervals and correlated to the clinical course ofthe patients. Results There were 2 patients alarms in our group. One alarm could be relatedto impending cardiac decompensation and weight gain (consequence: increase ofdiuretics), the other alarm could be related to technical reasons (change of thepace sense lead due to oversensing). Conclusion Our first preliminary results with the Optivol index showed a goodcorrelation to clinical data in patients with severe heart failure. Changes in thelead system can be one reason of non-specific alarms. [ABSTRACT FROM PUBLISHER]

Introduction Cardiac Resynchronization therapy (CRT) using coronary sinus (CS) leads is a new method for the therapy of congestive heart failure (CHF) in the case of inter- and intraventricular conduction delays. Because the intervention is more complex than regular pacemaker implantations more informations on the feasibility of this intervention are of interest. Methods From 1999-2004 n=255 transvenous coronary sinus leads were implanted in 234 CHF patients (mean age 61±17 years, 14-90 years age spectrum). 88% were over the wire leads, 71% preshaped and over the wire. Perioperative data were analyzed retrospectively. Results 84% of pts. were male, 44% of pts. had coronary artery disease, 30% of pts. were in atrial fibrillation, 78 pts. had preexisting pacemakers (upgrade procedure). 43 (16%) were implanted from the right subclavian vein, the others from the left side. Coronary sinus leads were positioned according to variable vein anatomies: 130x posterolateral, 97x anterolateral and 28x anterior (A). The mean operation time was 110 min +−, mean fluo time was 15,8 +− 11min. Severe complications were: CS dissection 5 cases (contrast media paravasation), ventricular fibrillation: 4 cases (defibrillation needed), asystole: 5 (pacing needed), pulmonary edema: 1 case, pneumothorax: 2 cases, acute CS lead dislodgement 5 cases, infection 1 case. In total we observed 23 severe complications. 12 patients had phrenic nerve stimulation, 5 of them needed reoperation. There were no death during the perioperative phase. 88% of pts. showed an improvement in their NYHA class and could be classified as responders unregardless of the underlying disease, the preexistence of atrial fibrillation or a conventional pacemaker. In regard to anterior lead position the rate of responders was lower (55%). Conclusion Coronary sinus lead implantation is a complex procedure with some hazards. The complication rate is in the range of 10%, but in our series these could be managed without mortality or persistent morbidity. Most patients responded very well to the procedure. Therefore CRT should be offered to otherwise untreatable CHF patients. Anterior CS lead positions should be avoided. [ABSTRACT FROM PUBLISHER]

A response from the author of the article "Combination therapy with carvedilol and amiodarone in patients with severe heart failure" in the 2000 issue is presented.

Introduction: Causes of epileptic seizures are often multifactorial but for an effective therapy, they should be uncovered in detail., Case Presentation: We present a 67-year-old male patient with a central diabetes insipidus, who experienced a generalized tonic-clonic seizure. The patient was treated with levetiracetam for prevention of further seizures, opioids and non-steroidal anti-inflammatory drugs, i.e., ibuprofen because of severe back pain due to vertebral compression fractures. In this setting, he developed significant hyponatremia and experienced another epileptic seizure. After stopping analgesics and switching from levetiracetam to lacosamide, sodium levels returned to normal and the patient remained free of seizures since then., Conclusion: The interrelationships of medical therapy, sodium levels and epileptic seizures in the context of central diabetes insipidus are discussed., Competing Interests: The authors declare that there exists no competing financial interest or personal relationships that could have appeared to influence the work reported in this paper. Unrelated to the paper, MPN reports speaker fees by AstraZeneca and Vifor Pharma, Advisory board and consultancy fees by Boehringer Ingelheim and Pierre Fabre and congress travel support by Pfizer. The CARE Checklist has been completed by the authors for this case report, attached as online supplementary material (for all online suppl. material, see https://doi.org/10.1159/000540320)., (© 2024 The Author(s). Published by S. Karger AG, Basel.)

Background: Device complications, such as infection or lead dysfunction necessitating transvenous lead extraction (TLE) are continuously rising amongst patients with transvenous implantable-cardioverter-defibrillator (ICD)., Objectives: Aim of this study was to characterize the procedural outcome and risk-factors of patients with indwelling 1- and 2-chamber ICD undergoing TLE., Methods: We conducted a subgroup analysis of all ICD patients in the GALLERY (GermAn Laser Lead Extraction RegistrY) database. Predictors for procedural failure and all-cause mortality were assessed., Results: We identified 842 patients with an ICD undergoing TLE with the mean age of 62.8 ± 13.8 years. A total number of 1610 leads were treated with lead dysfunction (48.5%) as leading indication for extraction, followed by device-related infection (45.4%). Lead-per-patient ratio was 1.91 ± 0.88 and 60.0% of patients had dual-coil defibrillator leads. Additional extraction tools, such as mechanical rotating dilator sheaths and snares were utilized in 6.5% of cases. Overall procedural complications occurred in 4.3% with 2.0% major complications and a procedure-related mortality of 0.8%. Clinical success rate was 97.9%. All-cause in-hospital mortality was 3.4%, with sepsis being the leading cause for mortality. Multivariate analysis revealed lead-age ≥10 years (OR:5.82, 95%CI:2.1-16.6; p = .001) as independent predictor for procedural failure. Systemic infection (OR:9.57, 95%CI:2.2-42.4; p < .001) and procedural complications (OR:8.0, 95%CI:2.8-23.3; p < .001) were identified as risk factors for all-cause mortality., Conclusions: TLE is safe and efficacious in patients with 1- and 2-chamber ICD. Although lead dysfunction is the leading indication for extraction, systemic device-related infection is the main driver of all-cause mortality for ICD patients undergoing TLE., (© 2023 Wiley Periodicals LLC.)

Background: The incidence of cardiac implantable electronic device (CIED)-related complications, as well as the prevalence of obesity, is rising worldwide. Transvenous laser lead extraction (LLE) has grown into a crucial therapeutic option for patients with CIED-related complications but the impact of obesity on LLE is not well understood., Methods and Results: All patients ( n = 2524) from the GermAn Laser Lead Extraction RegistrY (GALLERY) were stratified into five groups according to their body mass index (BMI, <18.5; 18.5-24.9; 25-29.9; 30-34.9; ≥35 kg/m 2 ). Patients with a BMI ≥ 35.0 kg/m 2 had the highest prevalence of arterial hypertension (84.2%, p < 0.001), chronic kidney disease (36.8%, p = 0.020) and diabetes mellitus (51.1%, p < 0.001). The rates for procedural minor ( p = 0.684) and major complications ( p = 0.498), as well as procedural success ( p = 0.437), procedure-related ( p = 0.533) and all-cause mortality ( p = 0.333) were not different between groups. In obese patients (BMI ≥ 30 kg/m 2 ), lead age ≥10 years was identified as a predictor of procedural failure (OR: 2.99; 95% CI: 1.06-8.45; p = 0.038). Lead age ≥10 years (OR: 3.25; 95% CI: 1,31-8.10; p = 0.011) and abandoned leads (OR: 3.08; 95% CI: 1.03-9.22; p = 0.044) were predictors of procedural complications, while patient age ≥75 years seemed protective (OR: 0.27; 95% CI: 0.08-0.93; p = 0.039). Systemic infection was the only predictor for all-cause mortality (OR: 17.68; 95% CI: 4.03-77.49; p < 0.001)., Conclusions: LLE in obese patients is as safe and effective as in other weight classes, if performed in experienced high-volume centers. Systemic infection remains the main cause of in-hospital mortality in obese patients.

Boundary extension is a classic memory illusion in which observers remember more of a scene than was presented. According to predictive-processing accounts, boundary extension reflects the integration of visual input and expectations of what is beyond a scene's boundaries. According to normalization accounts, boundary extension rather reflects one end of a normalization process toward a scene's typically experienced viewing distance, such that close-up views give boundary extension but distant views give boundary contraction. Here, across four experiments ( N = 125 adults), we found that boundary extension strongly depends on depth of field, as determined by the aperture settings on a camera. Photographs with naturalistic depth of field led to larger boundary extension than photographs with unnaturalistic depth of field, even when distant views were shown. We propose that boundary extension reflects a predictive mechanism with adaptive value that is strongest for naturalistic views of scenes. The current findings indicate that depth of field is an important variable to consider in the study of scene perception and memory.

Background: Transvenous lead extraction (TLE) has evolved as one of the most crucial treatment options for patients with cardiac device-related systemic infection (CDRSI)., Objective: The aim of this study was to characterize the procedural outcome and risk factors of patients with CDRSI undergoing TLE., Methods: A subgroup analysis of patients with CDRSI of the GALLERY (GermAn Laser Lead Extraction RegistrY) database was performed. Predictors for complications, procedural failure, and all-cause mortality were evaluated., Results: A total of 722 patients (28.6%) in the GALLERY had "systemic infection" as extraction indication. Patients with CDRSI were older (70.1 ± 12.2 years vs 67.3 ± 14.3 years; P < .001) and had more comorbidities than patients with local infections or noninfectious extraction indications. There were no differences in complete procedural success (90.6% vs 91.7%; P = .328) or major complications (2.5% vs 1.9%; P = .416) but increased procedure-related (1.4% vs 0.3%; P = .003) and all-cause in-hospital mortality (11.1% vs 0.6%; P < .001) for patients with CDRSI. Multivariate analyses revealed lead age ≥10 years as a predictor for procedural complications (odds ratio [OR] 3.23; 95% confidence interval [CI] 1.58-6.60; P = .001). Lead age ≥10 years (OR 2.57; 95% CI 1.03-6.46; P = .04) was also a predictor for procedural failure. We identified left ventricular ejection fraction <30% (OR 1.70; 95% CI 1.00-2.99; P = .049), age ≥75 years (OR 2.1; 95% CI 1.27-3.48; P = .004), chronic kidney disease (OR 1.92; 95% CI 1.17-3.14; P = .01), and overall procedural complications (OR 5.15; 95% CI 2.44-10.84; P < .001) as predictors for all-cause mortality., Conclusion: Patients with CDRSI undergoing TLE demonstrate an increased rate of all-cause in-hospital, as well as procedure-related mortality, despite having comparable procedural success rates. Given these data, it seems paramount to develop preventive strategies to detect and treat CDRSI in its earliest stages., (Copyright © 2022 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: Atrial fibrillation is the most common arrhythmia and has been described as driver of cardiovascular morbidity and risk factor for cardiac device-related complications, as well as in transvenous lead extraction (TLE). Objectives: Aim of this study was to characterize the procedural outcome and risk-factors of patients with atrial fibrillation (AF) undergoing TLE. Methods: We performed a subgroup analysis of all AF patients in the GALLERY (GermAn Laser Lead Extraction RegistrY) database. Predictors for all-cause mortality were assessed. Results: A total number of 510 patients with AF were identified with a mean age of 74.0 ± 10.3 years. Systemic infection (38.4%) was the leading cause for TLE, followed by local infection (37.5%) and lead dysfunction (20.4%). Most of the patients (45.9%) presented with pacemaker systems to be extracted. The total number of leads was 1181 with a 2.3 ± 0.96 leads/patient. Clinical procedural success was achieved in 97.1%. Occurrence of major complications was 1.8% with a procedure-related mortality of 1.0%. All-cause mortality was high with 5.9% and septic shock being the most common cause. Systemic device infection (OR: 49.73; 95% CI: 6.56−377.09, p < 0.001), chronic kidney disease (CKD; OR: 2.67; 95% CI: 1.01−7.03, p = 0.048) and a body mass index < 21 kg/m2 (OR: 6.6; 95% CI: 1.68−25.87, p = 0.007) were identified as independent predictors for all-cause mortality. Conclusions: TLE in AF patients is effective and safe, but in patients with systemic infection the mortality due to septic shock is high. Systemic infection, CKD and body mass index <21 kg/m2 are risk factors for death in patient with AF undergoing TLE.

Aims: The GermAn Laser Lead Extraction RegistrY: GALLERY is a retrospective, national multicentre registry, investigating the safety and efficacy of laser lead extraction procedures in Germany., Methods and Results: Twenty-four German centres that are performing laser lead extraction have participated in the registry. All patients, treated with a laser lead extraction procedure between January 2013 and March 2017, were consecutively enrolled. Safety and efficacy of laser lead extraction were investigated. A total number of 2524 consecutive patients with 6117 leads were included into the registry. 5499 leads with a median lead dwell time of 96 (62-141) months were treated. The mean number of treated leads per patient was 2.18 ± 1.02. The clinical procedural success rate was 97.86% and the complete lead removal was observed in 94.85%. Additional extraction tools were used in 6.65% of cases. The rate of procedural failure was 2.14% with lead age  ≥10 years being its only predictor. The overall complication rate was 4.32%, including 2.06% major and 2.26% minor complications. Procedure-related mortality was 0.55%. Female sex and the presence of abandoned leads were predictors for procedure-related complications. The all-cause in-hospital mortality was 3.56% with systemic infection being the strongest predictor, followed by age ≥75 years and chronic kidney disease., Conclusion: In the GALLERY, a high success- and low procedure-related complication rates have been demonstrated. In multivariate analysis, female sex and the presence of abandoned leads were predictors for procedure-related complications, while the presence of systemic infection, age ≥75 years, and chronic kidney disease were independent predictors for all-cause mortality., Competing Interests: Conflict of interest: S.P. reports grants and personal fees from Philips/Spectranetics, Medtronic, and AtriCure. H.B. reports grants and personal fees from Philips/Spectranetics, Cook Medical, Zoll Medical, Braun Medical, Abbott, Sorin Group/LivaNova, Impulse Dynamics, Biotronik, and Medtronic. B.O. reports grants and personal fees from Philips/Spectranetics and Medtronic. H.E. reports personal fees from Philips/Spectranetics. N.G. reports grants and personal fees from Boston Scientific, Medtronic, and Bayer Vital. M.K. reports grants and personal fees from Philips/Spectranetics, Zoll Medical, Sorin Group/LivaNova, Medtronic, Boston Scientific, and CVRx. H.R. reports personal fees from Medtronic. S.W. reports grants and personal fees from Abbott, Boston Scientific, Medtronic, Boehringer Ingelheim, Bristol Myers Squibb, Bayer Vital, Acutus, and Daiichi Sankyo. S.H. reports grants and personal fees from Boston Scientific, Edwards Lifesciences, Medtronic, Meril, Philips/Spectranetics, and Zoll Medical. All other authors have no conflicts of interest., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

The aim of the present study was to review the safety and efficiency of wearable cardioverter-defibrillators (WCDs) under current guideline-directed medical therapy (GDMT). We retrospectively analyzed 436 consecutive WCD patients seen in the years 2014-2020. Detected automatic arrhythmia alarm (AA) episodes were validated and classified as correct or incorrect. The positive predictive value (PPV) was calculated. GDMT was optimized in our outpatient clinic to maximal tolerated doses. During a total wear time (WT) of 23,527 days, 3,135 AAs were transmitted from 206 of 436 (47.2%) patients. Visual analysis revealed correct diagnoses of non-sustained ventricular tachycardia (VT) in 38 AAs from 6 patients (total PPV, 1.21%; PPV in VT patients, 41%); the remaining AAs were artifacts. No appropriate or inappropriate shocks and fatalities were recorded. LVEF significantly improved ( P < .001) during the WT from 25% (range, 20%-30%) to 40% (range, 34%-46%). Defibrillators were implanted in 109 patients (27%). The PPV for VT of the WCD was very low. There were fewer instances of true VT than previously reported, and no shocks (appropriate or inappropriate) were delivered. The majority of patients greatly improved with GDMT, and device implantation rates were lower than previously reported. Improvements in arrhythmia detection algorithms are warranted. Based on our results, WCDs are rarely needed for lifesaving shocks under optimal GDMT., Competing Interests: The authors report no conflicts of interest for the published content., (Copyright: © 2022 Innovations in Cardiac Rhythm Management.)