scholarly journals Defibrillation testing of subcutaneous versus transvenous defibrillators in the clinical practice: a nationwide survey in Italy

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
F Migliore ◽  
S Viani ◽  
M Ziacchi ◽  
L Ottaviano ◽  
L Checchi ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Hypertrophic Cardiomyopathy ◽  
Secondary Prevention ◽  
Ad Hoc ◽  
De Novo ◽  
Arrhythmogenic Right Ventricular Cardiomyopathy ◽  
Nationwide Survey ◽  
Icd Implantation ◽  
Shock Impedance ◽  
Patients At Risk

Abstract Aims According to current guidelines, defibrillation testing (DT) for efficacy can be omitted in patients undergoing transvenous implantable cardioverter–defibrillator (T-ICD) implantation. DT is still recommended for patients at risk for a high defibrillation threshold (e.g. hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, right-sided implantations) and for ICD generator changes. Moreover, a class I recommendation remains to perform DT during the implantation of subcutaneous ICD (S-ICD). The aim of the present survey was to analyze the current practice of DT during T-ICD and S-ICD implantations in Italy. Methods In March 2021, an ad hoc questionnaire on the current performance of DT and the standard practice adopted during testing was completed by 72 operators at Italian centers implanting S-ICD and T-ICD. Results 48 (67%) operators reported never performing DT during de-novo T-ICD implantations, while no operators perform it systematically. The remaining respondents perform it in specific cases: right sided implantations (54%), poor signal sensing (46%), secondary prevention patients (42%), arrhythmic syndromes (13%), hypertrophic cardiomyopathy (8%). DT is never performed at T-ICD generator change. At the time of de-novo S-ICD implantation, DT is never performed by 9 (13%) operators and performed systematically by 48 (66%). The remaining operators perform DT in cases of: secondary prevention patients (73%), sub-optimal S-ICD placement (33%), non-compromised ejection fraction (33%) or obese patients (7%). DT is not performed at S-ICD generator change by 92% of operators. DT is conducted by delivering a first shock energy of 65J by 60% of operators, while the remaining 40% test lower energy values. The most frequently reported conditions for revising the system at the end of de- novo implantation procedure is high shock impedance (54%) and sub-optimal S-ICD placement or high PRAETORIAN score (50%). With adequately low shock impedance and optimal system placement, 37% of operators would accept a defibrillation margin <15J. Conclusion In current clinical practice, the vast majority of operators omit DT at T-ICD implantation, even when still recommended in the guidelines. DT is also frequently omitted at S-ICD implantation. We also report a wide variability among operators in the procedures followed during DT and in the criteria applied for defining the procedural success. FUNDunding Acknowledgement Type of funding sources: None.

Abstract 11447: Low Incidence of Appropriate Therapy Following Defibrillator Implantation for Primary Prevention of Sudden Cardiac Death in Hypertrophic Cardiomyopathy

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Amalie C Thavikulwat ◽  
Todd T Tomson ◽  
Bradley P Knight ◽  
Robert O Bonow ◽  
Lubna Choudhury
Keyword(s):  
Risk Factors ◽  
Risk Factor ◽  
Hypertrophic Cardiomyopathy ◽  
Primary Prevention ◽  
Sudden Cardiac Death ◽  
Secondary Prevention ◽  
Cardiac Death ◽  
Icd Implantation ◽  
Icd Therapy ◽  
Appropriate Therapy

Introduction: Hypertrophic cardiomyopathy (HCM) is a leading cause of sudden cardiac death (SCD) in young adults. Implantable cardioverter defibrillators (ICD) effectively terminate ventricular tachycardia (VT) and fibrillation (VF) that cause SCD, but the reported prevalence of and patient characteristics leading to appropriate ICD therapy in HCM have been variable. Hypothesis: We hypothesized that some risk factors may be more prevalent than others in patients with HCM who receive appropriate ICD therapy and that the overall incidence of appropriate therapy may be lower than that reported previously. Methods: We retrospectively studied all patients with HCM who were treated with ICDs at our referral center from 2000-2013 to determine the rates of appropriate and inappropriate ICD therapies. Results: Of 1136 patients with HCM, we identified 135 who underwent ICD implantation (125 for primary and 10 for secondary prevention), aged 18-81 years (mean 48±17) at the time of implantation. The mean follow-up time was 5.2±4.5 years. Appropriate ICD intervention occurred in 20 of 135 patients (2.8%/year) by providing a shock or antitachycardia pacing in response to VT or VF. The annual rate of appropriate ICD therapy was 2.4%/year for primary and 7.2%/year for secondary prevention devices. Commonly used risk factors were equally prevalent among patients who received appropriate therapy and those who did not; furthermore, the likelihood of receiving appropriate therapy in the presence of each risk factor was similar (Figure). Inappropriate ICD therapy occurred in 27 patients (3.8%/year). Conclusions: ICDs provide clear benefit to patients who experience life-threatening arrhythmias, particularly those being treated for secondary prevention. However, the appropriate therapy rate for primary prevention was lower than previously reported, and no single risk factor appeared to have stronger association with appropriate ICD therapy than others.

scholarly journals ¿Esta plenamente justificada la suspensión la comercialización del Hidroxietil Almidón en la Unión Europea?

2018 ◽  
Vol 10 (8) ◽  
pp. 1
Author(s):  
Juan Pedro Macias Pingarrón
Keyword(s):  
At Risk ◽  
Clinical Practice ◽  
Critically Ill ◽  
Critically Ill Patients ◽  
Ad Hoc ◽  
Kidney Injury ◽  
La Réunion ◽  
Risk Minimisation ◽  
Safety Committee ◽  
Patients At Risk

El 12 de enero de 2018, el Comité de evaluación de riesgos de farmacovigilancia de la EMA (PRAC) recomendó la suspensión de HES del mercado europeo. Tras la evaluación de los datos de utilización de los medicamentos que contienen hidroxetil-almidón en diversos países europeos, el PRAC ha concluido que las medidas de minimización de riesgos introducidas en 2013 no han sido suficientemente efectivas. Por ello, ha recomendado la suspensión de la autorización de comercialización de los medicamentos con hidroxietil-almidón en la Unión Europea (UE). Los asistentes a la reunión de expertos ad-hoc de la EMA celebrada en Londres el 18 de diciembre de 2017, creen firmemente que la recomendación de la EMA de suspender HES no está fundamentada científicamente y es potencialmente peligrosa para los pacientes. ABSTRACT In January 2018, EMA’s safety committee PRAC recommended suspending the marketing authorisations of these medicines because they continued to be used in critically ill patients and patients with sepsis despite restrictions introduced in 2013 due to the risk of kidney injury and death in these patients. The CMDh agreed with the PRAC’s assessment of the serious risks in critically ill patients and patients with sepsis. However, the CMDh gave further consideration to the place of HES in the clinical practice of some countries, noted that previous risk minimisation measures had some effect, and considered that a combination of new risk minimisation measures would effectively ensure that HES solutions are not used in patients at risk.  

P988Implantable cardioverter defibrillators in patients with electrical heart disease and hypertrophic cardiomyopathy - data from the German device Registry

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
G Frommeyer ◽  
F Reinke ◽  
D Andresen ◽  
T Klemann ◽  
S G Spitzer ◽  
...  
Keyword(s):  
Heart Disease ◽  
Hypertrophic Cardiomyopathy ◽  
Secondary Prevention ◽  
Real Life ◽  
Control Group ◽  
Icd Implantation ◽  
Large Patient ◽  
Electrical Heart Disease ◽  
One Year

Abstract Background Implantable cardioverter- defibrillator (ICD) therapy is established for prevention of sudden cardiac death (SCD) in different entities. However, data from large patient cohorts on patients with electrical heart disease of hypertrophic cardiomyopathy (HCM) is rare. Therefore, we investigated these patients by analysing registry data from a multi-center “real-life” registry. Methods The German Device Registry (DEVICE) is a nationwide, prospective registry with one-year follow-up investigating 5450 patients receiving device implantations in 50 German centres. The present analysis of DEVICE focussed on patients with electrical heart disease or HCM who received an ICD for primary or secondary prevention. Results 174 patients with HCM and 112 patients with electrical heart disease were compared with 5164 other ICD patients. Median follow-up was 17.0 months. Patients in the control group were significantly older. Of note, overall mortality after one year was 1.8% in HCM patients, 6.6% in patients with electrical heart disease and 7.3% in the control group. Patients in the control group presented significantly more severe comorbidities. In contrast to HCM patients and the control group where primary prevention was the major indication for ICD implantation 77.5% of patients with electrical heart disease received an ICD for secondary prevention. The number of surgical revisions was higher in patients with electrical heart disease. Conclusion Data from the present registry display a surprisingly high mortality in patients with electrical heart disease equivalent to the control group. A high proportion of patients who received an ICD for secondary prevention may be regarded as a major determinant for these results while severe comorbidities such as diabetes, hypertension and renal failure are major determinants for mortality in the control cohort.

Secondary prevention of sudden cardiac death in hypertrophic cardiomyopathy

ESC CardioMed ◽  
2018 ◽  
pp. 2351-2354
Author(s):  
Wilhelm Haverkamp ◽  
Philipp Attanasio
Keyword(s):  
Ventricular Tachycardia ◽  
Hypertrophic Cardiomyopathy ◽  
Sudden Cardiac Death ◽  
Secondary Prevention ◽  
Cardiac Death ◽  
Recurrent Events ◽  
Sudden Cardiac Arrest ◽  
Heart Association ◽  
Level Of Evidence ◽  
Icd Implantation

The European Society of Cardiology and the American Heart Association guidelines recommend implantable cardioverter defibrillator (ICD) implantation in patients with hypertrophic cardiomyopathy who survived sudden cardiac arrest due to ventricular tachycardia or ventricular fibrillation or who experienced spontaneously occurring ventricular tachycardia causing syncope or haemodynamic compromise (class I indication, level of evidence B). These recommendations are based on several non-randomized trials which have shown that these patients remain at high risks of recurrent events. However, ICD therapy is associated with inappropriate shocks and device-related complications. In this chapter, the efficacy as well as the associated risks of treating hypertrophic cardiomyopathy patients with ICDs for secondary prevention of sudden cardiac death are discussed. Additionally, the chapter describes selection and appropriate programming of the devices.

P1157Defibrillation threshold with subcutaneous implantable-cardioverter defibrillator implanted using an intermuscular 2-incision approach

EP Europace ◽  
2020 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
M Biffi ◽  
M Ziacchi ◽  
C Martignani ◽  
C Lavalle ◽  
A Piro ◽  
...  
Keyword(s):  
De Novo ◽  
Safety Margin ◽  
Real Life ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Implantable Cardioverter Defibrillators ◽  
Icd Implantation ◽  
Ventricular Ejection Fraction ◽  
Shock Impedance ◽  
Incision Technique

Abstract Funding Acknowledgements NO FUNDING OnBehalf Rhythm Detect Registry Background Current subcutaneous implantable cardioverter–defibrillators (S-ICD) deliver 80J, and the conversion test is usually conducted by delivering shock energy of 65 J to ensure a safety defibrillation margin of at least 15 J. However, little is known about the real safety margin in real life clinical practice. Purpose To determine the defibrillation threshold (DFT) with S-ICD and to investigate its association with clinical characteristics. Methods De novo S-ICD patients were  consecutively enrolled and DFT was evaluated using a pre-specified step-up protocol at implantation. Results 35 patients, BMI 25 ± 4 kg/m2, left ventricular ejection fraction (LVEF) 48 ± 19%, underwent S-ICD implantation. The generator was positioned in an intermuscular pocket and a 2-incision technique was applied in all patients. The mean DFT was 30 ± 10J and the DFT was >30J in 7 (20%) patients. A single patient had a >40J DFT. The time to shock was 11 ± 3 seconds and the shock impedance was 67 ±21 Ohm at the lowest effective energy. The DFT was comparable in patients with LVEF ≤35% (33 ± 15J) versus >35% (29 ± 5J, p = 0.278), and in patients with BMI ≤25 kg/m2 (30 ± 5J) versus >25kg/m2 (31 ± 14J, p = 0.864). Conclusions We observed low DFT and low shock impedance in patients who received S-ICD with an intermuscular 2-incision approach. The S-ICD defibrillation success rate at ≤30J was 80%, while 97% of patients were defibrillated at ≤ 40J. We found no difference in DFT according to the LVEF or the BMI.

Secondary prevention in the clinical management of patients with cardiovascular diseases. Core components, standards and outcome measures for referral and delivery

2020 ◽  
Author(s):  
Lungwani Muungo
Keyword(s):  
Economic Growth ◽  
Developing Countries ◽  
Clinical Practice ◽  
Cardiovascular Diseases ◽  
Secondary Prevention ◽  
Health Authorities ◽  
Overwhelming Evidence ◽  
Core Components ◽  
Interventional Therapies ◽  
Limited Period

Despite major improvements in diagnostics and interventional therapies, cardiovascular diseases remain a major healthcare and socio-economic burden both in western and developing countries, in which this burden is increasing in closecorrelation to economic growth. Health authorities and the general population have started to recognize that the fightagainst these diseases can only be won if their burden is faced by increasing our investment on interventions in lifestylechanges and prevention. There is an overwhelming evidence of the efficacy of secondary prevention initiatives includingcardiac rehabilitation in terms of reduction in morbidity and mortality. However, secondary prevention is still too poorlyimplemented in clinical practice, often only on selected populations and over a limited period of time. The developmentof systematic and full comprehensive preventive programmes is warranted, integrated in the organization ofnational health systems. Furthermore, systematic monitoring of the process of delivery and outcomes is a necessity.

scholarly journals Factors That Cause Concerns after Cardioverter Defibrillator Implantation

2021 ◽  
Vol 18 (11) ◽  
pp. 6095
Author(s):  
Olimpia Karczewska ◽  
Agnieszka Młynarska
Keyword(s):  
Observational Study ◽  
Secondary Prevention ◽  
Negative Emotions ◽  
Female Gender ◽  
Multiple Regression Model ◽  
Icd Implantation ◽  
Cardioverter Defibrillator ◽  
Input Method ◽  
Two Stages

Background and Objectives: The aim of the study was to assess the factors that influence the occurrence of concerns and their intensification after the implantation of a cardioverter defibrillator. Materials and Methods: This was a prospective and observational study including 158 patients. The study was conducted in two stages: stage I before implantable cardioverter defibrillator (ICD) implantation and stage II follow-up visit six months after ICD implantation. Standardized questionnaires were used in both stages. Results: Age and female gender were significantly correlated with the occurrence and intensity of concerns. Patients who had a device implanted for secondary prevention also experienced higher levels of concern. Additionally, a multiple regression model using the stepwise input method was performed. The model was statistically significant and explained 42% of the observed variance in the dependent variable (p = 0.0001, R2 = 0.4215). The analysis showed that age (p = 0.0036), insomnia (p = 0.0276), anxiety (p = 0.0000) and negative emotions (p = 0.0374) were important predictors of the dependent variable and enabled higher levels of the number of concerns to be predicted. Conclusions: There is a relationship between the severity of the concerns related to an implanted ICD and age, gender, anxiety, negative emotions and insomnia. Indications for ICD implantation may be associated with increased concerns about ICD.

Revisiting the risk of undesired appeal in investment treaty arbitration: is deference to the tribunal’s award still less likely in the ICSID context?

2021 ◽  
Author(s):  
Alexander J Marcopoulos
Keyword(s):  
Ad Hoc ◽  
De Novo ◽  
Case Law ◽  
Court Decisions ◽  
Investment Treaty ◽  
Investment Treaty Arbitration ◽  
The Way

Abstract Although they are generally not subject to appeal the way court decisions typically are, investor-State arbitration awards can be reviewed—and potentially set aside—in a number of ways and on various bases. In this respect, investor-State arbitration under the auspices of ICSID is notable in that it provides a self-contained system for the review of arbitral awards by ICSID-appointed ad hoc committees. In the period 2000–2010, this feature of the ICSID system attracted criticism as ad hoc committees appeared to be overreaching in their review of arbitral awards, exercising less deference to the tribunal’s decisions than what would be expected given the narrow bases for setting aside an award under the ICSID Convention. This article revisits the issue 10 years later, exploring whether ICSID practice has evolved in these areas and whether there remains a greater risk of unexpected de novo review by ICSID ad hoc committees. Looking at recent ICSID annulment decisions as well as the case law of arbitration-friendly jurisdictions, the article concludes that although the ICSID ad hoc committees have recently shown more restraint, they continue to interfere more with the tribunal’s reasoning and decisions than many courts exercising the same function.

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