Tenth International Symposium HEART FAILURE & Co. CARDIOLOGY SCIENCE UPDATE FEMALE DOCTORS SPEAKING ON FEMALE DISEASES Milano 9 - 10 aprile 2010 ICD data.

Slides:



Advertisements
Similar presentations
The prevalence of use of beta- blockers in secondary prevention of myocardial infarctions in patients hospitalized 1 Institute of Epidemiology and biostatistics,
Advertisements

The MADIT II Trial Multicenter Autonomic Defibrillator Implantation Trial II Presented at the American College of Cardiology 51st Annual Scientific Session.
Tenth International Symposium HEART FAILURE & Co. CARDIOLOGY SCIENCE UPDATE FEMALE DOCTORS SPEAKING ON FEMALE DISEASES Milano aprile 2010 FEDERICA.
Telemonitoring for Heart Failure Evidence & Practice Professor John G.F. Cleland Department of Cardiology, Hull York Medical School University of Hull.
Multicenter Automatic Defibrillator Implantation Trial II
Cardiac Insufficiency Bisoprolol Study (CIBIS III) Trial
Sudden Cardiac Death Prevention: Clinical Trials Alena Goldman, MD September 9, 2004.
CMR of Non-ischemic Dilated and Restrictive Cardiomyopathies
Cardiac Resynchronization Heart Failure Study Cardiac Resynchronization Heart Failure Study Presented at American College of Cardiology Scientific Sessions.
Natale MARRAZZO Francesco SOLIMENE Quando la CRT-P può bastare?
La stratificazione del rischio aritmico oltre la frazione di eiezione Milano 17 Aprile 2009 Prof. Luigi Padeletti Heart Failure & Co.
Implantable Cardioverter Defibrillators to Prevent Sudden Cardiac Death: Background Frederick A. Masoudi, MD, MSPH Associate Professor of Medicine (Cardiology)
Outcome of Patients with Advanced Heart Failure who Receive Device- Based Therapy for Primary Prevention of Sudden Cardiac Death, G. Amit, N. Samniah,
Atrial Fibrillation and Sudden Death: Are they linked? Mariell Jessup MD Professor of Medicine University of Pennsylvania Philadelphia, Pennsylvania.
CONSENSUS: Cooperative North Scandinavian Enalapril Survival Study Purpose To determine whether the ACE inhibitor enalapril reduces mortality in patients.
PACT Clinical Trial Commentary Dr Eric Topol Chairman and Professor, Department of Cardiology Director of the Joseph J Jacobs Center for Thrombosis and.
Gillian D Sanders Ph.D.Lurdes Y Inoue Ph.D. Associate Professor of MedicineAssociate Professor of Biostatistics Duke UniversityUniversity of Washington.
ICD FOR PRIMARY PREVENTION EVIDENCE REVIEW
Sex Differences in Implantable Cardioverter Defibrillator (ICD) Implantation indications and outcomes Guy Amit, MD; Mahmoud Suleiman, MD; Mark Kazatsker,
Prognostic Value of Programmed Electrical Stimulation Among Implantable Cardioverter-Defibrillator Recipients Real-World Data from the Israeli National.
Indications of ICD in 2010 Dr Mervat Aboulmaaty Professor of Cardiology Ain Shams University DAF 1 st EP course 2010.
Sudden Cardiac Death in Heart Failure Trial Presented at American College of Cardiology Scientific Sessions 2004 Presented by Dr. Gust H. Bardy SCD-HeFTSCD-HeFT.
Alon Barsheshet, MD1, Paul J. Wang, MD2, Arthur J. Moss, MD1, Scott D
COURAGE: Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation Purpose To compare the efficacy of optimal medical therapy (OMT)
Cholesterol-Lowering Therapy in Women and Elderly Patients with Myocardial Infarction or Angina Pectoris Findings From the Scandinavian Simvastatin Survival.
Cardiovascular Disease in Women Module V: Prognosis and Treatment Outcomes.
Clinical Characteristics and Outcomes of Elderly Patients Treated With ICD and CRTD in Real World Setting: Data From the Israeli ICD Registry M. Suleiman,
Author Disclosures Differences in Implantation-Related Adverse Events Between Men and Women Receiving ICD Therapy for Primary Prevention Differences in.
Coverage with Evidence Development Implantable Cardioverter Defibrillators 1 Sean Tunis MD, MSc June 23, 2009.
Management of Elevated Cholesterol in the Primary Prevention Group of Adult Japanese (MEGA) Trial MEGA Trial Presented at The American Heart Association.
S. HUNT Tenth International Symposium HEART FAILURE & Co. CARDIOLOGY SCIENCE UPDATE FEMALE DOCTORS SPEAKING ON FEMALE DISEASES Milano aprile 2010.
M. JESSUP Tenth International Symposium HEART FAILURE & Co. CARDIOLOGY SCIENCE UPDATE FEMALE DOCTORS SPEAKING ON FEMALE DISEASES Milano aprile 2010.
An ICD for every CRT patient ?
Logo Authors & Affiliations : Josep L Clua-Espuny (1), Teresa Forcadell-Arenas (1), Rosa Ripolles-Vicente (1), Panisello-Tafalla(1), Antonia González-Henares.
Which Beta-Blocker is Best for Patients with Heart Failure? Summary and Comment by Joel M. Gore, MD Published in Journal Watch Cardiology December 17,
Door to Balloon Time: Does it Matter? Tale of Two Studies.
Long-term mortality and thrombolysis therapy after a first acute ischemic stroke: gender differences. Ebrictus II Study. Authors & Affiliations Clua-Espuny.
Perindopril Remodeling in Elderly with Acute Myocardial Infarction PREAMIPREAMI Presented at The European Society of Cardiology Hot Line Session, September.
Candesartan in Heart Failure Presented at European Society of Cardiology 2003 CHARM Trial.
Rosuvastatin 10 mg n=2514 Placebo n= to 4 weeks Randomization 6weeks3 monthly Closing date 20 May 2007 Eligibility Optimal HF treatment instituted.
The Case for Rate Control: In the Management of Atrial Fibrillation Charles W. Clogston, M.D. Cardiologist CHI St. Vincent Heart Clinic Arkansas April.
Effect of Spironolactone on Diastolic Function and Exercise Capacity in Patients with Heart Failure with preserved Ejection Fraction Effect of Spironolactone.
Ten Year Outcome of Coronary Artery Bypass Graft Surgery Versus Medical Therapy in Patients with Ischemic Cardiomyopathy Results of the Surgical Treatment.
Survival with Cardiac- Resynchronization Therapy in Mild Heart Failure.
Date of download: 6/26/2016 Copyright © The American College of Cardiology. All rights reserved. From: Clinical Effectiveness of CRT and ICD Therapy in.
Author Disclosure Sex Differences in the Characteristics of Patients Receiving ICD Therapy for the Primary Prevention of Sudden Cardiac Death –Stacie L.
Ventricular Arrhythmias:A General Cardiologist’s Assessment of Therapies in 2004 C.Richard Conti M.D. MACC.
Defibrillator in Acute Myocardial Infarction Trial Presented at American College of Cardiology Scientific Sessions 2004 Presented by Drs. Stewart Connelly.
Summary of “A randomized trial of standard versus intensive blood-pressure control” The SPRINT Research Group, NEJM, DOI: /NEJMoa Downloaded.
Sudden Cardiac Arrest Morhaf Ibrahim, MD, FHRS Electrophysiology.
Clinical Trial Commentary
These slides highlight a presentation at the Late Breaking Trial Session of the American College of Cardiology 52nd Annual Scientific Sessions in Chicago,
Title slide.
Defibrillator in Acute Myocardial Infarction Trial
Revascularization in Patients With Left Ventricular Dysfunction:
Scandinavian Simvastatin Survival Study (4S)
Valsartan in Acute Myocardial Infarction Trial Investigators
Cardiovacular Research Technologies
Preventing SCD With a WCD: Reviewing the Results of the VEST Trial
BENEFIT Trial design: Patients with positive serologic tests for T. Cruzi and cardiomyopathy were randomized to benznidazole 300 mg daily for days.
Systolic Blood Pressure Intervention Trial (SPRINT)
The following slides highlight a presentation at the Late-Breaking Clinical Trials session of the American Heart Association Scientific Sessions, November.
The most common cause of death in North America is cardiac death and the most common cause of cardiac death is sudden death from ventricular arrhythmias.
DANISH Trial design: Patients with nonischemic cardiomyopathy were randomized to ICD implantation (n = 556) versus usual care (n = 560). Results (p = 0.28)
Section III: Neurohormonal strategies in heart failure
European Heart Association Journal 2007 April
MASTER Trial Inclusion Criteria
Section III: Neurohormonal strategies in heart failure
Baseline Demographic Characteristics of Adults With Diagnosed Heart Failure and Eligible to Receive Lipid-Lowering Therapy Alan S. Go, et al.
The Heart Rhythm Society Meeting Presented by Dr. Johan De Sutter
Presentation transcript:

Tenth International Symposium HEART FAILURE & Co. CARDIOLOGY SCIENCE UPDATE FEMALE DOCTORS SPEAKING ON FEMALE DISEASES Milano aprile 2010 ICD data in Women are Inconclusive: Do we need a sex specific trial? Valeria Calvi Università di Catania U.O. di Aritmologia Ospedale Ferrarotto

Cattedra di Cardiologia Università di Catania ICD Trials

Cattedra di Cardiologia Università di Catania 2004

Cattedra di Cardiologia Università di Catania Survival Free From Arrhythmic Death or Cardiac Arrest Overall Survival 2004

Cattedra di Cardiologia Università di Catania 1232 patients: 192 (16%) women and 1,040 (84%) men The cumulative probability of sudden cardiac death in conventionally treated patients was similar by gender In the ICD treatment arm, the 2-year mortality rate was found to be 16% in both men and women 2005

Cattedra di Cardiologia Università di Catania year probability of appropriate ICD therapy for VT/VF was significantly lower in women Cumulative probability of death after first appropriate ICD therapy was non significantly different Women presented with somewhath higher risk of hospitalization for CHF in both treatment groups

Cattedra di Cardiologia Università di Catania 458 patients: 326 man (71%), 132 women (29%) No difference in the incidence of arrhythmic death in men (n = 10; 6%) versus women (n = 4; 6%) No evidence for a sex difference in the effectiveness of the ICD in reducing mortality among patients with NISCM 2008

Cattedra di Cardiologia Università di Catania A total of 2,521 patients, 588 (23%) women and 1,933 (77%) men Treatment effects appear different between genders with a smaller ICD benefit among women; but this difference was not significant (P=0,54) 2008

Cattedra di Cardiologia Università di Catania No difference in risk of cardiac arrhythmic death in men versus women (36% vs. 39%, P = 0.34) No difference in the risk of appropriate shock therapy for men versus women (P = 0.25). 2008

Cattedra di Cardiologia Università di Catania 2008

Cattedra di Cardiologia Università di Catania patients, women comprised 19% (293/1.530) After adjusting for baseline characteristics and medical therapy, there was no significant difference in the outcome and mortality between women and men (HR = 1.05, P = 0.83) 2009

Cattedra di Cardiologia Università di Catania A total of 6% of men and 8% of women received an appropriate ICD shock during the follow-up (HR = 1.37, P = 0.19) Adverse events (pulse generator-, lead-, and patient-related cardiovascular events) were observed more commonly in women 2009

Cattedra di Cardiologia Università di Catania Mortality among men with systolic dysfunction randomized to ICD implantation vs medical therapy for the primary prevention of SCD Mortality among women with systolic dysfunction randomized to ICD implantation vs medical therapy for the primary prevention of SCD

Cattedra di Cardiologia Università di Catania

Cattedra di Cardiologia Università di Catania Benefits of ICD in women No trial powered to separately examine outcomes in men and women or test for difference in ICD effectiveness Small numbers of women enrolled Limited post-hoc analyses for females do not clearly demonstrate a mortality benefit: - SCD-HeFT: benefit not clear (not powered for gender) - MADIT II: nonsignificant trend to lower mortality in females but analysis limited by too few female subjects Meta-analysis: 934 females in 5 trials; no difference in all- cause mortality for women with ICD vs medical Rx

Cattedra di Cardiologia Università di Catania Number of Patients Enrolled Who Received ICDs in Clinical Trials

Cattedra di Cardiologia Università di Catania Am Heart J 1998

Cattedra di Cardiologia Università di Catania The prevalence of HF increases with age for both sexes, with more women than men having HF after 79 years of age Survival is better for women - Women with acute decompensated HF tend to have preserved LV function almost twice as often as men and those with impaired LV systolic function tend to present with a higher LVEF when compared with men - Women have less ischemic cardiomyopathy - Other? Gender differences in geometric remodeling, myocyte cell loss, and gene expression have been reported JACC 2009

Cattedra di Cardiologia Università di Catania SCD in Women JACC 2009 CAD is the most common urderlying cardiovascular disease in patients with SCD

Cattedra di Cardiologia Università di Catania Portland, Oregon, Metropolitan Area, Feb 2002 to Jan 2007 (n 1,568) Demographics and Cardiac Arrest Circumstances in Men and Women Age >35 Years With SCA

Cattedra di Cardiologia Università di Catania Conclusions Since fewer women may be eligible for ICD implantation based on LVEF criteria alone, the identification of novel SCA risk predictors for women becomes an important priority. JACC 2009

Cattedra di Cardiologia Università di Catania ICD in Women Community-based studies reported that only 25% to 30% of SCAs occur in subjects who have severely reduced LV systolic function Women account for only 10%-29% of the study populations in ICD clinical trials Men are significantly more likely to undergo ICD implantion for both primary and secondary prevention of SCA

Cattedra di Cardiologia Università di Catania Women represent 27% of patients receiving ICD for primary prevention in clinical practice in USA. Possible explanations: - Selection criteria are applied more stringently to women - Trial criteria are being applied more stringently among older women than older men with no significant gender differences among younger patients - Women are less commonly referred for invasive cardiac procedures - Older women have more coexisting illnesses and higher complication rates and are therefore viewed as less likely to benefit from therapy - Older women may be more likely to refuse ICD therapy compared to men - Higher complications rates of ICD implantation in women Am Heart J 2009

Cattedra di Cardiologia Università di Catania pts, 27% women

Cattedra di Cardiologia Università di Catania Females with lower rates of SCD than males Differences in arrhythmia susceptibility 30% of ICDs are implanted in females Even though the benefit is less, it may represent a clinically significant reduction in deaths Ghanbari et al. Arch Int Med 2009 Redberg RF. Arch Int Med 2009 Conclusions

Cattedra di Cardiologia Università di Catania Conclusions A trial targeting women is needed To detect the same ICD benefit in women as was observed in men with 90% power and α=0.05, a study larger than SCDHeFT would be required (1.585 women in each treatment arm, total) It may now even be considered unethical to withhold ICD therapy in women meeting the SCD-HeFT enrollment criteria.

Cattedra di Cardiologia Università di Catania Lingiustizia di sempre…