[Mobile health for detection of atrial fibrillation-Status quo and perspectives]. / Mobile Health zur Detektion von Vorhofflimmern ­ Status quo und Perspektiven.

Mobile health (mHealth) for the detection of atrial fibrillation is an innovative domestic monitoring of the heart rhythm. The use of mHealth in the context of atrial fibrillation increases the availability of diagnostic technologies and facilitates the integration into telemedical treatment concepts as well as the active participation of patients in the treatment process. The detection of atrial fibrillation with mHealth applications is usually based on electrocardiography (ECG) or by detection of the pulse wave using photoplethysmography (PPG). Some applications require additional sensors, others make use of sensors integrated into smartphones or smartwatches. A high diagnostic accuracy for the detection of atrial fibrillation has been shown for most mHealth applications regardless of the underlying technology (analytical validation); however, the evidence on positive care effects and improvement of medical endpoints (clinical validation) is so far scarce. Screening of symptomatic or asymptomatic patients and the follow-up care after antiarrhythmic measures are possibilities for the integration into the reality of care. The preventive detection of atrial fibrillation is an attractive field of application for mHealth with great potential for the future. Nevertheless, at present mHealth is only integrated to a limited extent into the reality of patient care. Adequate reimbursement and medical remuneration as well as opportunities to derive information and qualification are prerequisites in order to be able to guarantee a comprehensive implementation in the future. The Digital Health Care Act passed in 2019, regulates the reimbursement of digital healthcare applications but issues of primary preventive applications have not yet been included.

Acute and chronic effects of endocardial radiofrequency ablation of septal hypertrophy in HOCM.

INTRODUCTION: Endocardial radiofrequency ablation of septal hypertrophy (ERASH) is an alternative to alcohol septal ablation (ASA) or surgical myectomy for hypertrophic obstructive cardiomyopathy (HOCM). Several studies have confirmed that septal radiofrequency ablation leads to a significant reduction in the left ventricular outflow tract gradient. OBJECTIVES: We aimed to report the outcomes of 41 patients who underwent ERASH with a focus on severe complications. METHODS: Since 2004, 41 patients with HOCM (age: 58.2 ± 13 years) underwent ERASH at our institution. ERASH was performed, since ASA was ineffective (26 patients) or not possible (15 patients). RESULTS: The left ventricular outflow tract and the right ventricular septum were ablated in 26 and 15 patients, respectively. ERASH resulted in a significant reduction in acute gradient during the session and the results persisted during the 6-month follow-up (67% gradient reduction at rest and 73% after provocation, p = .0002). Pacemaker dependency after ERASH was 29% and pericardial tamponade occurred in two patients. In four patients, ERASH induced a paradoxical increase in obstruction (PIO), beginning suddenly at 30 min after the procedure and leading to lethal shock in one patient. PIO was not observed after ERASH from the right ventricular aspect. CONCLUSION: Morbidity and mortality after ERASH were higher than those after ASA. PIO, a life-threatening complication, was observed in 9% of the patients. Our data indicate that ERASH might be considered in patients who are not candidates for surgical myectomy or ASA.

Early outcomes of alcohol septal ablation for hypertrophic obstructive cardiomyopathy: a European multicenter and multinational study.

BACKGROUND: This study was designed to evaluate the outcomes of alcohol septal ablation (ASA) under multicenter and multinational conditions. METHODS: Data for 459 patients (age 57 ± 13 years) from nine European centers were prospectively collected and retrospectively analyzed. RESULTS: ASA led to a significant reduction in outflow gradient (PG) and dyspnea [median of PG from 88 (58-123) mm Hg to 21 (11-41) mm Hg; median of NYHA class from 3 (2-3) to 1 (1-2); P < 0.01]. The incidence of 3-month major adverse events (death, electrical cardioversion for tachyarrhythmias, resuscitation) and mortality was 2.8% and 0.7%, respectively. Permanent pacemakers for post-ASA complete heart block were implanted in 43 patients (9%). Multivariate analysis identified higher amount of alcohol (however, in generally low-dose procedures), higher baseline left ventricular ejection fraction and higher age as independent predictors of PG decrease ≥50%. CONCLUSIONS: The results of the first European multicenter and multinational study demonstrate that real-world early outcomes of ASA patients are better than was reported in observations from the first decade after ASA introduction.

Evaluation of a semiautomated App Store analysis for the identification of health apps for cardiac arrhythmias.

BACKGROUND: Smartphone apps are increasingly utilised by patients and physicians for medical purposes. Thus, numerous applications are provided on the App Store platforms. OBJECTIVES: The aim of the study was to establish a novel, expanded approach of a semiautomated retrospective App Store analysis (SARASA) to identify and characterise health apps in the context of cardiac arrhythmias. MATERIALS AND METHODS: An automated total read-out of the "Medical" category of Apple's German App Store was performed in December 2022 by analysing the developer-provided descriptions and other metadata using a semiautomated multilevel approach. Search terms were defined, based on which the textual information of the total extraction results was automatically filtered. RESULTS: A total of 435 of 31,564 apps were identified in the context of cardiac arrhythmias. Of those, 81.4% were found to deal with education, decision support, or disease management, and 26.2% (additionally) provided the opportunity to derive information on heart rhythm. The apps were intended for healthcare professionals in 55.9%, students in 17.5%, and/or patients in 15.9%. In 31.5%, the target population was not specified in the description texts. In all, 108 apps (24.8%) provided a telemedicine treatment approach; 83.7% of the description texts did not reveal any information on medical product status; 8.3% of the apps indicated that they have and 8.0% that they do not have medical product status. CONCLUSION: Through the supplemented SARASA method, health apps in the context of cardiac arrhythmias could be identified and assigned to the target categories. Clinicians and patients have a wide choice of apps, although the app description texts do not provide sufficient information about the intended use and quality.

Prolonged mHealth-Based Arrhythmia Monitoring in Patients With Hypertrophic Cardiomyopathy (HCM-PATCH): Protocol for a Single-Center Cohort Study.

BACKGROUND: Patients with hypertrophic cardiomyopathy (HCM) are at increased risk of sudden cardiac death (SCD) due to ventricular arrhythmias and other arrhythmias. Screening for arrhythmias is mandatory to assess the individual SCD risk, but long-term electrocardiography (ECG) is rarely performed in routine clinical practice. Intensified monitoring may increase the detection rate of ventricular arrhythmias and identify more patients with an increased SCD risk who are potential candidates for the primary prophylactic implantation of an implantable cardioverter-defibrillator. To date, reliable data on the clinical benefit of prolonged arrhythmia monitoring in patients with HCM are rare. OBJECTIVE: This prospective study aims to measure the prevalence of ventricular arrhythmias in patients with HCM observed by mobile health (mHealth)-based continuous rhythm monitoring over 14 days compared to standard practice (a 24- and 48-h long-term ECG). The frequency of ventricular arrhythmias in this 14-day period is compared with the frequency in the first 24 or 48 hours for the same patient (intraindividual comparison). METHODS: Following the sample size calculation, 34 patients with a low or intermediate risk for SCD, assessed by the HCM Risk-SCD calculator, will need to be recruited in this single-center cohort study between June 2023 and February 2024. All patients will receive an ECG patch that records their heart activity over 14 days. In addition, cardiac magnetic resonance imaging and genetic testing data will be integrated into risk stratification. All patients will be asked to complete questionnaires about their symptoms; previous therapy; family history; and, at the end of the study, their experience with the ECG patch-based monitoring. RESULTS: The Hypertrophic Cardiomyopathy: Clinical Impact of a Prolonged mHealth-Based Arrhythmia Monitoring by Single-Channel ECG (HCM-PATCH) study investigates the prevalence of nonsustained ventricular tachycardia (ie, ≥3 consecutive ventricular beats at a rate of 120 beats per minute, lasting for <30 seconds) in low- to intermediate-risk patients with HCM (according to the HCM Risk-SCD calculator) with additional mHealth-based prolonged rhythm monitoring. The study was funded by third-party funding from the Department of Cardiology and Intensive Care Medicine, University Hospital Ostwestfalen-Lippe of Bielefeld University in June 2023 and approved by the institutional review board in May 2023. Data collection began in June 2023, and we plan to end the study in February 2024. Of the 34 patients, 26 have been recruited. Data analysis has not yet taken place. Publication of the results is planned for the fall of 2024. CONCLUSIONS: Prolonged mHealth-based rhythm monitoring could lead to differences in the prevalence of arrhythmias compared to 24- and 48-hour long-term ECGs. This may lead to improved identification of patients at high risk and trigger therapeutic interventions that may provide better protection from SCD or atrial fibrillation-related complications such as embolic stroke. TRIAL REGISTRATION: Deutsches Register Klinischer Studien DRKS00032144; https://tinyurl.com/498bkrx8. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/52035.

Alcohol septal ablation in patients aged 75 years or older with hypertrophic obstructive cardiomyopathy.

OBJECTIVE: Outcome data for patients ≥75 years with hypertrophic obstructive cardiomyopathy (HOCM) undergoing alcohol septal ablation (ASA) are lacking. Therefore, a retrospective single-centre analysis was conducted. METHODS: The data of all consecutive ASAs, that were performed at our institution between 1 September 1997 and 31 July 2021 in patients with HOCM with left ventricular outflow tract gradients (LVOTG) ≥50 mm Hg, were collected from patient reports. ASA was performed per institutional standards with 95% ethanol infused into a feasible septal branch. Differences regarding echocardiographic, procedural and clinical parameters at baseline and after 6 months between patients ≥75 years and <75 years were assessed. RESULTS: We found 208 ASAs in patients ≥75 years (85.1% female; age 78.0 years (IQR 76.0-80.0)) and 1430 ASAs in patients <75 years (42.0% female; age 56.0 years (IQR 46.0-65.0)). Patients ≥75 years had lower distances in 6 min walk test (baseline: 317.0 m (IQR 242.0-389.0) vs 438.0 m (IQR 353.3-504.0); p<0.0001). Exercise-induced LVOTG calculated at follow-up was lower in patients ≥75 years (29.5 mm Hg (IQR 18.0-54.0) vs 39.5 mm Hg (IQR 23.0-73.8); p=0.0007). There were more high-degree AV blocks after ASA in patients ≥75 years (25.5% vs 13.6%; p<0.0001). The in-hospital mortality did not differ between the groups (age ≥75 years: 1.0%; age <75 years: 0.6%; p=0.6580). CONCLUSION: ASA had similar efficacy and intrahospital mortality in patients ≥75 years compared with younger patients. Higher rates of AV block with need for permanent pacemaker implantation were observed in patients ≥75 years of age.

Cryoballoon ablation of atrial fibrillation in octogenarians: one year outcomes from the cryo global registry.

BACKGROUND: Limited information is available on the safety and efficacy of cryoballoon ablation (CBA) in elderly patients with atrial fibrillation (AF). Moreover, global utilization of CBA in this population (≥ 80 years old) has not been reported. This study's objectives were to determine the use, efficacy, and safety of CBA to treat octogenarians suffering from AF. METHODS: In this sub-analysis of the Cryo Global Registry, 12-month outcomes of treating AF via CBA in octogenarians were compared to patients < 80 years old. Efficacy was evaluated as time to a ≥ 30 s atrial arrhythmia (AA) recurrence. Healthcare utilization was determined via repeat ablations and hospitalizations. Improvement upon disease burden was evaluated through patient reporting of symptoms and the EQ-5D-3L quality of life (QoL) survey. RESULTS: The octogenarian cohort (n = 101) had a higher prevalence of females (51.5% vs 35.7%) and CHA2DS2-VASc scores (4.2 ± 1.3 vs 2.0 ± 1.5) compared to the control cohort (n = 1573, both p < 0.01). Even when adjusting for baseline characteristics and antiarrhythmic drug usage, freedom from AA recurrence at 12 months (80.6% vs 78.9%, HRadj:0.97 [95% CI:0.59-1.58], p = 0.90) was comparable between octogenarians and control, respectively. Similar serious adverse event rates were observed between octogenarians (5.0%) and control (3.2%, p = 0.38). The groups did not differ in healthcare utilization nor reduction of AF-related symptoms from baseline to follow-up, but both experienced an improvement in QoL at 12 months. CONCLUSIONS: Despite more age-related comorbidities, CBA is a safe and effective treatment for AF in octogenarians, with efficacy and adverse events rates akin to ablations performed in younger patients. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT02752737.

Case report of a patient with congenital long QT syndrome Type 2 presenting with electrical storm: do not judge a book by its cover!

Background: Patients with congenital long QT syndrome (LQTS) are at high risk for sudden cardiac death (SCD). Although several triggers can provoke ventricular fibrillation (VF) in patients suffering from LQTS acquired heart disease in addition to LQTS should not be overlooked. Case summary: We present a case of a 47-year-old female patient who was diagnosed with congenital LQTS Type 2 at the age of 23 after surviving SCD. At that time, she underwent implantable cardioverter-defibrillator (ICD) implantation and was free of events for 24 years. Recently, the patient was referred to our institution after suffering from an ICD shock during sleep. Upon arrival she developed electrical storm and received overall six ICD shocks. The initial electrocardiogram (ECG) showed atrially triggered ventricular pacing. However, distinct ST segment elevations in the inferior leads could be observed. Thus, coronary angiography was immediately performed and showed subtotal occlusion of the right coronary artery, which was treated by drug-eluting stent implantation. Atrioventricular conduction immediately resumed after revascularization and the following non-paced ECG revealed a prolonged QT interval. Laboratory measurements confirmed acute myocardial infarction with elevated cardiac enzymes. The patient was put on betablockers, dual antiplatelet therapy, and statins and discharged in good condition. Discussion: This case report highlights that diagnostic work-up in patients with LQTS presenting with VF should always include the search for additional acquired heart disease such as myocardial infarction, as a potential trigger for electrical storm. Moreover, signs of ischaemia can be discerned even in a paced ECG which should lead to immediate cardiac catheterization.

Safety and efficacy of alcohol septal ablation in adolescents and young adults with hypertrophic obstructive cardiomyopathy.

INTRODUCTION: Data regarding alcohol septal ablation (ASA) in young patients with hypertrophic obstructive cardiomyopathy (HOCM) are scarce. The purpose of our study is to evaluate the safety and efficacy of ASA in patients ≤ 25 years. METHODS AND RESULTS: All ASAs between 2002 and 2020 at our institution were assigned to a group of patients 14-25 years of age (group 1) and a reference group > 25 years (group 2). 1,264 procedures were analysed in group 2 (58.6 ± 13.5 years) and 41 procedures in group 1 (20.9 ± 3.3 years). The baseline interventricular septal diameter (IVSD) was higher in group 1 (26.0 ± 6.5 mm vs. 21.3 ± 4.4 mm; p < 0.0001). There was no difference in baseline left ventricular outflow tract gradient (LVOTG) (group 1: 54.4 ± 24.4 mmHg; group 2: 52.4 ± 36.6 mmHg; p = n.s.). A previous cardiac device was more often observed in group 1 (31.7% vs. 9.0%; p < 0.0001). Symptoms were improved after 6 months (group 1: mean NYHA class 2.5 at baseline and 1.3 at FU; p < 0.0001; group 2: mean NYHA class 2.7 at baseline and 1.4 at FU; p <0 .0001). IVSD (group 1: 20.3 ± 8.2 mm; group 2: 16.8 ± 5.7 mm; p < 0.0001 for each group compared to baseline) and LVOTG improved during FU (group 1: 25.5 ± 20.0 mmHg; group 2: 22.1 ± 21.7 mmHg; p < 0.0001 for each group). Intrahospital mortality was 0.0% in patients 14-25 years and 0.9% in the reference group. Persistent AV-block was observed in 12.2% of the group 1 and 15.9% of the group 2 patients (p = n.s.). CONCLUSION: ASA is safe and effective in HOCM patients 14-25 years of age in experienced centres.

Use of digital health applications for the detection of atrial fibrillation.

The advances in health care technologies over the last decade have led to improved capabilities in the use of digital health applications (DiHA) for the detection of atrial fibrillation (AFib). Thus, home-based remote heart rhythm monitoring is facilitated by smartphones or smartwatches alone or combined with external sensors. The available products differ in terms of type of application (wearable vs. handheld) and the technique used for rhythm detection (electrocardiography [ECG] vs. photoplethysmography [PPG]). While ECG-based algorithms often require additional sensors, PPG utilizes techniques integrated in smartphones or smartwatches. Algorithms based on artificial intelligence allow for the automated diagnosis of AFib, enabling high diagnostic accuracy for both ECG-based and PPG-based DiHA. Advantages for clinical use result from the widespread accessibility of rhythm monitoring, thereby permitting earlier diagnosis and higher AFib detection rates. DiHA are also useful for the follow-up of patients with known AFib by monitoring the success of therapeutic interventions to restore sinus rhythm, e.g. catheter ablation. Although some studies strongly suggest a potential benefit for the use of DiHA in the setting of AFib, the overall evidence for an improvement in hard, clinical endpoints and positive effects on clinical care is scarce. To enhance the acceptance of DiHA use in daily practice, more studies evaluating their clinical benefits for the detection of AFib are required. Moreover, most of the applications are still not reimbursable, although the German Digital Health Care Act (Digitale-Versorgung-Gesetz, DVG) made reimbursement possible in principle in 2019.

Alcohol-induced right bundle branch block is associated with a benign outcome in HOCM after alcohol septum ablation (ASA).

INTRODUCTION: Alcohol septum ablation (ASA) is a treatment option for hypertrophic obstructive cardiomyopathy (HOCM). We examined the impact of ASA-induced bundle branch block (BBB) on clinical and hemodynamic features. METHODS AND RESULTS: We retrospectively analysed 98 HOCM patients with regard to ASA-induced BBB. Clinical examination was performed at baseline, early after ASA and at chronic follow-up (FU). ASA reduced left ventricular outflow tract gradient (LVOTG) during chronic FU (69.2 ± 41.6 pre vs. 31.8 ± 30.3 mmHg post ASA; p < 0.05) and interventricular septal diameter (21.7 ± 3.4 pre vs. 18.7 ± 5.0 mm post ASA; p < 0.05). ASA-induced early right BBB (RBBB) until discharge was observed in 44.9% and chronic RBBB at FU in 32.7%. Left BBB (LBBB) occurred in 13.3% early after ASA and in only 4.1% at chronic FU. Chronic RBBB was associated with more pronounced exercise-induced LVOTG reduction (102.1 ± 55.2 with vs. 73.6 ± 60.0 mmHg without; p < 0.05). 6-min-walk-test (6-MWT) and NYHA class were not affected by RBBB. LBBB had no influence on LVOTG, 6-MWT and symptoms. More ethanol was injected in patients with early RBBB (1.1 ± 0.4 vs. 0.8 ± 0.3 ml without; p < 0.05), who also showed higher mean CK release (827 ± 341 vs. 583 ± 279 U/l without; p < 0.05). Pacemaker implantation during FU was necessary in 11.5% of patients with early RBBB, 3.1% with chronic RBBB, 7.7% with early LBBB and 0% with chronic LBBB (p = n.s. for BBB vs. no BBB). CONCLUSION: ASA-induced RBBB is associated with a higher volume of infused ethanol and higher maximum CK release. RBBB does not adversely affect the clinical outcome or need for pacemaker implantation but was associated with higher exercise-induced LVOTG reduction during chronic FU.

Gender disparities in alcohol septal ablation for hypertrophic obstructive cardiomyopathy.

OBJECTIVE: Alcohol septal ablation (ASA) improves symptoms in hypertrophic obstructive cardiomyopathy (HOCM). We conducted a large retrospective analysis investigating gender effects on outcome after ASA. METHODS AND RESULTS: 1367 ASAs between 2002 and 2020 were analysed. Women (47.2%) were older (66.0 years (IQR 55.0-74.0) vs 54.0 years (IQR 45.0-62.0); p<0.0001) with more severe symptoms. The interventricular septal diameter (IVSD) was higher in men (21.0 mm (IQR 19.0-24.0) vs 20.0 mm (IQR 18.0-23.0); p<0.0001) but the IVSD indexed to body surface area was higher in women (10.9 mm/m2 (IQR 9.7-12.7) vs 10.2 mm/m2 (IQR 9.0-11.7); p<0.0001). Women had lower exercise-induced left ventricular outflow tract gradients (LVOTG) 1-4 days after ASA (55.0 mm Hg (IQR 30.0-109.0) vs 71.0 mm Hg (IQR 37.0-115.0); p=0.0006). There was a trend for lower resting LVOTG 1-4 days after ASA (20.0 mm Hg (IQR 12.0-37.5) vs 22.0 mm Hg (IQR 13.0-40.0); p=0.0062) and lower exercise-induced LVOTG after 6 months in women (34.0 mm Hg (IQR 21.0-70.0) vs 43.5 mm Hg (IQR 25.0-74.8); p=0.0072), but this was not statistically significant after Bonferroni correction. More women developed atrioventricular (AV) block (20.3% vs 13.3%; p=0.0005) and required a pacemaker (17.4% vs 10.4%; p=0.0002) but not a cardioverter defibrillator (9.0% vs 11.6% in men; p=n .s.). However, in multivariable regression models, there was no evidence that sex independently influenced LVOTG and the occurrence of AV block. CONCLUSION: Female patients with HOCM were older and had more advanced disease at the time of ASA. Women had superior short-term haemodynamic response to ASA but more often developed AV block after ASA. These results are important to consider for sex-specific counselling before ASA.

Cannabis-induced recurrent myocardial infarction in a 21-year-old man: a case report.

BACKGROUND: Acute coronary syndrome (ACS) is rarely caused by coronary artery disease in young patients unless cardiovascular risk factors are present. Although non-atherosclerotic causes of ACS are rare, they need to be considered in young patients. CASE SUMMARY: We report on a 21-year-old patient referred to our institution with ACS. Electrocardiogram showed ST-segment elevation and coronary angiography revealed thrombotic occlusion of the left anterior descending artery. Reperfusion was achieved by thrombus aspiration, glycoprotein IIb/IIIa inhibitors (GPI), and drug-eluting stent (DES). The patient had no cardiovascular risk factors but reported cannabis consumption before symptom onset. Although he was put on dual antiplatelet therapy and strictly advised to avoid consumption, he continued to abuse cannabis and suffered three further ACS events within 18 months: the first 8 months later caused by thrombotic occlusion of a diagonal branch treated by GPI and DES, the second after 17 months due to thrombotic re-occlusion of the diagonal branch, and the third after 18 months by thrombotic occlusion of the circumflex artery, both events treated by GPI alone (all while still using cannabis). Since then, he stopped cannabis consumption and has been symptom-free for 8 months. DISCUSSION: This case highlights that cannabis-induced ACS must be considered as a cause of myocardial infarction in young adults. In contrast to ACS in the elderly population, this unusual ACS cause requires specific treatment. The risk of ACS relapse may substantial if cannabis abuse is continued. This potential hazard needs to be taken into consideration when legalization of cannabis is discussed.

Implantable cardioverter-defibrillators and prevention of sudden cardiac death in hypertrophic cardiomyopathy.

CONTEXT: Recently, the implantable cardioverter-defibrillator (ICD) has been promoted for prevention of sudden death in hypertrophic cardiomyopathy (HCM). However, the effectiveness and appropriate selection of patients for this therapy is incompletely resolved. OBJECTIVE: To study the relationship between clinical risk profile and incidence and efficacy of ICD intervention in HCM. DESIGN, SETTING, AND PATIENTS: Multicenter registry study of ICDs implanted between 1986 and 2003 in 506 unrelated patients with HCM. Patients were judged to be at high risk for sudden death; had received ICDs; underwent evaluation at 42 referral and nonreferral institutions in the United States, Europe, and Australia; and had a mean follow-up of 3.7 (SD, 2.8) years. Measured risk factors for sudden death included family history of sudden death, massive left ventricular hypertrophy, nonsustained ventricular tachycardia on Holter monitoring, and unexplained prior syncope. MAIN OUTCOME MEASURE: Appropriate ICD intervention terminating ventricular tachycardia or fibrillation. RESULTS: The 506 patients were predominately young (mean age, 42 [SD, 17] years) at implantation, and most (439 [87%]) had no or only mildly limiting symptoms. ICD interventions appropriately terminated ventricular tachycardia/fibrillation in 103 patients (20%). Intervention rates were 10.6% per year for secondary prevention after cardiac arrest (5-year cumulative probability, 39% [SD, 5%]), and 3.6% per year for primary prevention (5-year probability, 17% [SD, 2%]). Time to first appropriate discharge was up to 10 years, with a 27% (SD, 7%) probability 5 years or more after implantation. For primary prevention, 18 of the 51 patients with appropriate ICD interventions (35%) had undergone implantation for only a single risk factor; likelihood of appropriate discharge was similar in patients with 1, 2, or 3 or more risk markers (3.83, 2.65, and 4.82 per 100 person-years, respectively; P = .77). The single sudden death due to an arrhythmia (in the absence of advanced heart failure) resulted from ICD malfunction. ICD complications included inappropriate shocks in 136 patients (27%). CONCLUSIONS: In a high-risk HCM cohort, ICD interventions for life-threatening ventricular tachyarrhythmias were frequent and highly effective in restoring normal rhythm. An important proportion of ICD discharges occurred in primary prevention patients who had undergone implantation for a single risk factor. Therefore, a single marker of high risk for sudden death may be sufficient to justify consideration for prophylactic defibrillator implantation in selected patients with HCM.

[Indication for myocardial biopsy in myocarditis and dilated cardiomyopathy]. / Indikation der Herzmuskelbiopsie bei Myokarditis und dilatativer Kardiomyopathie.

This review may serve as a basis for evaluating publications on the topic "myocardial biopsy for myocarditis and dilated cardiomyopathy" in the clinical practice. The literature is particularly analyzed to answer the question, whether an endomyocardial catheter biopsy is indicated in patients with these myocardial disorders in the clinical routine besides its unequivocal scientific value. The judgment of the biopsy samples has been based on the classically histological and for years on the additional immunohistochemical and molecular biological-virological examination. The analysis of the literature data shows that outside scientific studies there is no indication to perform myocardial biopsy, or in other words, this procedure is not suitable for diagnosis, therapy, detection of early stages or prognostic evaluation in the disease spectrum "myocarditis, inflammatory heart disease, dilated cardiomyopathy". Reasons are the subjectivity in the judgment and interpretation of bioptic findings resulting in considerable interobserver variability, a missing standardization in biopsy performance, methods of examination and diagnostic criteria, the bioptic sampling error, missing therapeutic and prognostic consequences and potentially severe complications in performing myocardial biopsies. So far, the specificity of inflammatory changes in patients with dilated cardiomyopathy has not been proven in controlled blinded studies. The bioptic changes could be understood also as an unspecific inflammatory process in front of increasing pathophysiological evidence for myocardial inflammation in any form of heart failure. In addition, regarding the specific etiology of dilated cardiomyopathy, primarily a genetic, noninfectious or autoimmunologic origin plays an increasing role. The favorable clinical course and the very good prognosis of the acute, clinically diagnosed or supposed viral myocarditis should also be taken into account for the evaluation of myocardial biopsy. It should also be considered that the proof of causality between acute myocarditis and dilated cardiomyopathy is still lacking. Regarding the diagnosis "inflammatory cardiomyopathy" and multiple inflammatory subsets among patients with dilated cardiomyopathy or unclear regional contraction disorder, there is no adequate clinical validation of different diagnostic methods, criteria and interpretations so far. It is missleading to replace the well-established clinical diagnosis myocarditis by the bioptic diagnosis "inflammatory cardiomyopathy". However, endomyocardial catheter biopsy is clearly indicated in rare patients with fulminant myocarditis, giant-cell myocarditis and myocardial storage disease. Its probably underestimated role in sarcoid heart disease still needs to be clarified by systematic studies.

Low incidence of procedure-related major adverse cardiac events after alcohol septal ablation for symptomatic hypertrophic obstructive cardiomyopathy.

BACKGROUND: Alcohol septal ablation (ASA) is a catheter-based intervention that has been used as an alternative to surgical myectomy in highly symptomatic patients with hypertrophic obstructive cardiomyopathy (HOCM). However, clinically relevant complications can result, including death and complete heart block (CHB) associated with syncope or resuscitation. This study was designed to evaluate the incidence of major ASA-related adverse cardiac events. METHODS: This international multicentre retrospective study included 421 patients in 8 European centres who were treated using ASA from April 1998 to January 2011. Clinical and echocardiographic follow-up (3-6 months) was completed in 394 patients (94%). RESULTS: ASA led to a significant reduction in symptoms and outflow gradients, with 0.7% mortality. A total of 70 patients (17%) experienced mostly transient CHB during and after the procedure; in 30% of them, CHB occurred or recurred later than 24 hours after ASA. Ninety-seven percent of CHB occurred up to the fifth day after ASA. Permanent pacemakers for CHB were implanted in 35 patients (8%). Multivariate analysis identified intraprocedural bundle branch block and age as independent predictors of CHB. CONCLUSIONS: The results of the multicentre study demonstrate that ASA appears safe and efficacious, with low early mortality. The most frequent major complication after ASA was CHB (17%), which occurred late or was recurrent in almost one-third of these patients; 8% of patients required permanent pacemaker implantation. Independent predictors of CHB development were intraprocedural bundle branch block and age. Difficulty in predicting CHB should lead to close postprocedural monitoring and hospital stays lasting at least 5 days.

Endocardial radiofrequency ablation for hypertrophic obstructive cardiomyopathy: acute results and 6 months' follow-up in 19 patients.

OBJECTIVES: The purpose of this study was to examine the efficacy and safety of endocardial radiofrequency ablation of septal hypertrophy (ERASH) for left ventricular outflow tract (LVOT) gradient reduction in hypertrophic obstructive cardiomyopathy (HOCM). BACKGROUND: Anatomic variability of the vessels supplying the obstructing septal bulge can limit the efficacy of transcoronary ablation of septal hypertrophy in HOCM. Previous studies showed that inducing a local contraction disorder without reducing septal mass results in effective gradient reduction. We examined an alternative endocardial approach to transcoronary ablation of septal hypertrophy by using ERASH. METHODS: Nineteen patients with HOCM were enrolled; in 9 patients, the left ventricular septum was ablated, and in 10 patients, the right ventricular septum was ablated. Follow-up examinations (echocardiography, 6-min walk test, bicycle ergometry) were performed 3 days and 6 months after ERASH. RESULTS: After 31.2 ± 10 radiofrequency pulses, a significant and sustained LVOT gradient reduction could be achieved (62% reduction of resting gradients and 60% reduction of provoked gradients, p = 0.0001). The 6-min walking distance increased significantly from 412.9 ± 129 m to 471.2 ± 139 m after 6 months, p = 0.019); and New York Heart Association functional class was improved from 3.0 ± 0.0 to 1.6 ± 0.7 (p = 0.0001). Complete atrioventricular block requiring permanent pacemaker implantation occurred in 4 patients (21%); 1 patient had cardiac tamponade. CONCLUSIONS: ERASH is a new therapeutic option in the treatment of HOCM, allowing significant and sustained reduction of the LVOT gradient as well as symptomatic improvement with acceptable safety by inducing a discrete septal contraction disorder. It may be suitable for patients not amenable to transcoronary ablation of septal hypertrophy or myectomy.

Survival after transcoronary ablation of septal hypertrophy in hypertrophic obstructive cardiomyopathy (TASH): a 10 year experience.

BACKGROUND: Catheter-based treatment of patients with hypertrophic obstructive cardiomyopathy (HOCM) by alcohol ablation (transcoronary ablation of septal hypertrophy, TASH) leads to symptomatic and haemodynamic improvement. However, little is known regarding the survival and its evolution since the introduction of the method in 1995. Theoretically, the method may be harmful, because widening of the obstructed left ventricular outflow tract is achieved by a septal infarction and subsequently by a potentially arrhythmogenic scar. OBJECTIVE: This study sought to determine the impact of TASH on the survival of all patients with HOCM treated in our institution between 1995 and 2005. METHODS: Survival was assessed from the early beginning in each of 644 consecutive patients to April 2005. Group A comprises a first series of 329 patients who were treated in a dose finding strategy with decreasing amounts of ethanol until December 2001, on average, from 2.9 ml to 0.93 ml/patient. The survival of this group was analysed using Kaplan-Meier estimates, multivariate Cox regression and Log-Rank testing. Group B comprises 315 patients of the following "low alcohol dose era" (mean amount of ethanol 0.8 +/- 0.4 ml, range 0.3-1.5 ml) and their mid-term survival (period to first regular 6-month post-procedural control). RESULTS: All patients (age 58 +/- 15 years, 99.2% follow up, mean 1.4 years): 33 patients died (5.1% all cause mortality), including perioperative deaths. 14/33 (42%) died from cardiac reasons. Annual total (all cause) mortality was 3.2%, total in-hospital mortality 1.2% in all patients (8 of 644 patients, 6 of them with severe comorbidity) and 0.4% in low risk patients. Annual cardiac mortality after hospital discharge was 0.7% (6 patients, all with sudden death). Group A (age 58 +/- 15 years, 98.8% follow up, mean 2.1 years, maximum 6.2 years): 29 patients died (total annual mortality 4.3%), 10 of them from hypertrophic cardiomyopathy related reasons resulting in a total in-hospital mortality of 1.8% (6 deaths), a cardiac annual mortality of 1.5% (including hospital mortality) and 0.6%/year after hospital discharge. Age was identified as an independent predictor of increased overall mortality (P = 0.002) and lower alcohol dosage and the absence of atrial fibrillation as independent predictors of reduced cardiac mortality (P = 0.005 and P = 0.039, respectively). With focus on the median value of the alcohol quantity (2.0 ml), patients treated with high amounts (>2.0 ml) showed a higher total mortality than patients treated with small amounts (< or =2.0 ml) (P = 0.031) and alcohol turned out to be an independent predictor of survival (P = 0.047). The same holds true for a homogenous subset of 262 patients with respect to cardiac mortality (P = 0.018). Group B (age 57 +/- 14 years, 99.7% follow up, mean 7.3 months): Total in-hospital mortality was 0.6% (2 of 315 patients; P = 0.173, group A/B) and cardiac in-hospital mortality 0% (P = 0.016, group A/B). During follow up two patients died, both of them experienced a sudden death reflecting an annual mortality of 1.0%. CONCLUSION: These data represent the largest available database on survival after alcohol septal ablation of HOCM from a single centre with large experience, and its evolution over 10 years with increasing procedural experience including the pronounced reduction of ethanol quantity in a systematic doses finding strategy. The in-hospital mortality has become very low. Cardiac survival during follow up was excellent, however, the well-known risk of sudden death is not completely eliminated. Longer follow-up time would be desirable for definite evaluation of this relatively new therapeutic option in the management of HOCM.