Abstract 3630: Sex Differences in the Characteristics of Patients Receiving ICD Therapy for Primary Prevention

Circulation ◽  
2007 ◽  
Vol 116 (suppl_16) ◽  
Author(s):  
Stacie L Daugherty ◽  
Pamela N Peterson ◽  
Yongfei Wang ◽  
Jeptha P Curtis ◽  
Paul A Heidenreich ◽  
...  

Background: Prior studies suggest that women are less likely than men to be referred for ICD implantation for the primary prevention of sudden cardiac death. We hypothesized that women who undergo primary prevention ICD implantation would be more likely to meet strict evidence-based criteria for this therapy. Methods: We studied 59,833 patients in the NCDR ICD national registry who underwent first-time primary prevention ICD placement between January 2005 and April 2007. Patients were classified according to whether or not they met enrollment criteria of either of two primary prevention trials (MADIT-II: prior MI, LVEF ≤ 30% and MI>40 days or SCD-HeFT: prior heart failure; LVEF≤ 35%, and NYHA class II or III, unless receiving a biventricular pacemaker/ICD (BiV ICD), in which case NYHA IV was considered acceptable). Multivariable analyses assessed the association between sex and concordance with trial enrollment criteria after adjustment for demographic, clinical and health system characteristics. Results: Among the primary prevention cohort, 27% (n=16,079) were women. Compared with men, women were more often non-white (23.5% vs. 16.8%, p<0.01) had higher NYHA classifications (62.9% vs. 54.7% in class III or IV, p<0.01), and more frequently had a history of heart failure (88.3% vs. 83.2%, p<0.01) and non-ischemic cardiomyopathy (47.0% vs. 28.1%, p<0.01). Women were also more likely to receive a BiV ICD than men (49.4% vs. 42.2%, p<0.01). Overall, 86.1% of women and 85.6% of men met the major primary prevention trials enrollment criteria (p=0.08). Men more often failed to meet trial criteria due to LVEF above cutoff (9.5% vs. 6.7%, p<0.01) or having an MI≤ 40 days before implant (5.7% vs. 4.5%, p<0.01). In multivariable analyses, women were significantly more likely to meet either trial enrollment criteria (OR 1.09, 95% CI 1.03–1.15) than men. Conclusions : In a large national registry of patients undergoing primary prevention ICD implantation, women were slightly more likely than men to meet the enrollment criteria for MADIT II or SCD-HeFT. As it is not known if patients who fail to meet these criteria benefit from ICD implantation, the implications of this differential pattern of use on outcomes should be investigated.

Author(s):  
Maciej Kempa ◽  
Andrzej Przybylski ◽  
Szymon Budrejko ◽  
Tomasz Fabiszak ◽  
Michał Lewandowski ◽  
...  

The implantation of a subcutaneous cardioverter-defibrillator (S-ICD) may be used instead of a traditional transvenous system to prevent sudden cardiac death. Our aim was to compare the characteristics of S-ICD patients from the multi-center registry of S-ICD implantations in Poland with the published results of the European Snapshot Survey on S-ICD Implantation (ESSS-SICDI). We compared data of 137 Polish S-ICD patients with 68 patients from the ESSS-SICDI registry. The groups did not differ significantly in terms of sex, prevalence of ischemic cardiomyopathy, concomitant diseases, and the rate of primary prevention indication. Polish patients had more advanced heart failure (New York Heart Association (NYHA) class III: 11.7% vs. 2.9%, NYHA II: 48.9% vs. 29.4%, NYHA I: 39.4% vs. 67.7%, p < 0.05 each). Young age (75.9% vs. 50%, p < 0.05) and no vascular access (7.3% vs. 0%, p < 0.05) were more often indications for S-ICD. The percentage of patients after transvenous system removal due to infections was significantly higher in the Polish group (11% vs. 1.5%, p < 0.05). In the European population, S-ICD was more frequently chosen because of patients’ active lifestyle and patients’ preference (both 10.3% vs. 0%, p < 0.05). Our analysis shows that in Poland, compared to other European countries, subcutaneous cardioverters-defibrillators are being implanted in patients at a more advanced stage of chronic heart failure. The most frequent reason for choosing a subcutaneous system instead of a transvenous ICD is the young age of a patient.


Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Giulia Magnani ◽  
Robert P Giugliano ◽  
Christian T Ruff ◽  
Sabina A Murphy ◽  
Francesco Nordio ◽  
...  

BACKGROUND: Atrial fibrillation (AF) and heart failure (HF) have emerged as the two epidemics of cardiovascular (CV) disease. The prevalence of AF increases with the severity of HF and contributes to HF disability. Among patients treated with vitamin K antagonists (VKAs), symptomatic HF is an independent risk factor for lower time in therapeutic range (TTR), which reduces the efficacy and safety of VKAs. METHODS: In the ENGAGE AF-TIMI 48 trial, both once-daily regimens of the direct oral factor Xa inhibitor edoxaban [high (HDE) and low dose (LDE)], were non inferior to warfarin (W) for prevention of stroke and systemic embolic events (SEE) in patients with AF and were associated with lower rates of bleeding. We evaluated the safety and the efficacy of edoxaban compared with W in patients with HF presenting with different severity of functional limitation (NYHA class). RESULTS: Among 21,105 patients enrolled 8,981(43%) had no history of HF, 9,489 (45%) had history of HF and a NYHA class I-II, whereas 2,635 (13%) had symptomatic HF with NYHA class III-IV. Patients with more severe HF symptoms had higher rates of stroke SEE, CV death and CV hospitalization (p<0.0005 for all) and among those treated with W we observed a lower mean TTR (62.6% vs. 70.0%, p<0.001). Compared with W, the efficacy of both edoxaban doses in reducing stroke or SEE was similar between patients with and without HF (HDE vs. W, p int=0.96; LDE vs. W, p int=0.63, Fig.) and there were no differences between NYHA classes. CV hospitalization was significantly reduced with HDE relative to W, without heterogeneity by different NYHA classes (p int=0.5, Fig.). Both edoxaban regimens reduced consistently major bleeding and intracranial hemorrhage, regardless of HF severity (Fig.). CONCLUSION: The relative efficacy and safety of both edoxaban regimens, compared to well-managed W in AF patients with HF, was consistent irrespective of the severity of functional class.


Circulation ◽  
2007 ◽  
Vol 116 (suppl_16) ◽  
Author(s):  
Pam N Peterson ◽  
Stacie A Luther ◽  
Yongfei Wang ◽  
Humberto J Vidaillet ◽  
Harlan M Krumholz ◽  
...  

Background: Studies suggest that women are at higher risk for complications with some invasive cardiac procedures. Little is known about ICD implantation-related complications in community practice. We compared rates of in-hospital complications in men and women receiving an ICD for primary prevention. Methods: Using the NCDR ICD registry, we identified a cohort of patients receiving an ICD for primary prevention of sudden cardiac death between January 2005 and April 2007. Outcomes included all complications and major complications (cardiac arrest, perforation, valve injury, coronary venous dissection, hemothorax, pneumothorax, deep phlebitis, TIA/stroke, tamponade, MI, and AV fistula). Multivariable analysis assessed the association between gender and complications, adjusting for demographic, clinical, procedural, physician, and hospital characteristics. Secondary analyses stratified by device type (ICD vs. biventricular (BiV) ICD). Results: Of the 59,833 patients, 73% were male and 27% were female. Women were more likely to have a history of heart failure (88% vs. 83%; p<0.01), worse NYHA functional status (57% vs. 50% NYHA Class III; p<0.01), and non-ischemic cardiomyopathy (47% vs. 28%; p<0.01). Women were also more likely to receive BiV ICDs (46% vs. 39%; p<0.01). In unadjusted analyses, women were more likely to experience any complication and major complications (Table ). In multivariable models, women had a significantly higher risk of any complications and major complications. Results were similar when stratified by device type. Conclusions: Women are more likely than men to have in-hospital complications related to ICD implantation. As complications attenuate the benefits that might accrue from ICD therapy, the higher risk of complications may influence the decision to implant a device in women. Additionally, strategies specifically directed at preventing complications will be important to improving outcomes after ICD implantation.


2015 ◽  
Vol 2015 ◽  
pp. 1-10 ◽  
Author(s):  
Aderville Cabassi ◽  
Simone Maurizio Binno ◽  
Stefano Tedeschi ◽  
Gallia Graiani ◽  
Cinzia Galizia ◽  
...  

Rationale. Heart failure (HF) is accompanied by the development of an imbalance between oxygen- and nitric oxide-derived free radical production leading to protein nitration. Both chlorinating and peroxidase cycle of Myeloperoxidase (MPO) contribute to oxidative and nitrosative stress and are involved in tyrosine nitration of protein. Ceruloplasmin (Cp) has antioxidant function through its ferroxidase I (FeOxI) activity and has recently been proposed as a physiological defense mechanism against MPO inappropriate actions.Objective. We investigated the relationship between plasma MPO-related chlorinating activity, Cp and FeOxI, and nitrosative stress, inflammatory, neurohormonal, and nutritional biomarkers in HF patients.Methods and Results. In chronic HF patients (n=81, 76±9 years, NYHA Class II (26); Class III (29); Class IV (26)) and age-matched controls (n=17, 75±11 years, CTR), plasma MPO chlorinating activity, Cp, FeOxI, nitrated protein, free Malondialdehyde, BNP, norepinephrine, hsCRP, albumin, and prealbumin were measured. Plasma MPO chlorinating activity, Cp, BNP, norepinephrine, and hsCRP were increased in HF versus CTR. FeOxI, albumin, and prealbumin were decreased in HF. MPO-related chlorinating activity was positively related to Cp (r= 0.363,P<0.001), nitrated protein, hsCRP, and BNP and inversely to albumin.Conclusions. Plasma MPO chlorinated activity is increased in elderly chronic HF patients and positively associated with Cp, inflammatory, neurohormonal, and nitrosative parameters suggesting a role in HF progression.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
E Calero ◽  
E Hidalgo ◽  
R Marin ◽  
L Rosenfeld ◽  
I Fernandez ◽  
...  

Abstract Background Self-care is a crucial factor in the education of patients with heart failure (HF) and directly impacts in the progression of the disease. However, little is published about its major clinical implications as admission or mortality in patients with HF. Aims and methods The aim of the study was to analyze time to admission due to acute heart failure and mortality associated with poor self-care in patients with chronic HF. We prospectively recruited consecutive patients with stable chronic HF referred to a nurse-led HF programme. Selfcare was evaluated at baseline with the 9 item European Heart Failure Self-Care Behavior Scale. Scores were standardized and reversed from 0 (worst selfcare) to 100 (better self care). For the purpose of this study we analyzed the associations of worse self-care (defined as scores below the lower tertile of the scale) with demographic, disease-related (clinical) and psychosocial factors in all patients at baseline. Results We included 1123 patients, mean age 72±11, 639 (60%) were male, mean LVEF 45±17 and 454 (40,4%) were in NYHA class III or IV. Mean score of the 9-item ESCBE was 69±28. Score below 55 (lower tertile) defined impaired selfcare behaviour. Those patients with worse self-care had more ischaemic heart disease, more COPD, and they achieved less distance in the 6 minute walking test. Regarding psychosocial items patients in lower tertile of self-care needed a caregiver more frequently, they present more cognitive impairment, depressive symptoms and worse score in terms of health self-perception. Multivariate Cox Models showed that a score below 55 points in 9-item ESCBE was independently associated with higher readmission due to acute heart failure [HR 1.26 (1.02–1.57), p value=0.034] and with mortality [HR 1.24 CI95% (1.02–1.50), p value=0.028] Conclusion Poor self-care measured with the modified 9-item ESCBE was associated with higher risk of admission due to acute decompensation and higher risk of mortality in patients with chronic heart failure. These results highlight the importance of assessing self-care and provide measures to improve them. Funding Acknowledgement Type of funding source: Public hospital(s). Main funding source(s): Hospital Univesitario de Bellvitge


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
U Zeymer ◽  
L.H Lund ◽  
V Barrios ◽  
C Fonseca ◽  
A.L Clark ◽  
...  

Abstract Background Heart failure (HF) is a major medical and economic burden that is often managed in office based practices. Recently, the angiotensin receptor neprilysin inhibitor (ARNI) sacubitril/valsartan (S/V) was introduced as novel therapeutic option into European guidelines for the management of HF. The ARIADNE registry aims to provide information on how outpatients with HF with reduced ejection fraction (HFrEF) are managed in Europe, in light of this novel treatment option. Methods ARIADNE was a prospective registry of patients with HFrEF treated by office-based cardiologists (OBC) or selected primary care physicians (recognized as HF specialists; PCP) in a real world setting. HFrEF patients were included prospectively, independently of whether treatment had been changed recently or not. 9069 patients were recruited from 687 centres in 17 European countries. Results The mean age of all patients was 68.1 years (S/V: 67.3 years, Non-S/V: 68.9 years). The majority of patients were in NYHA class II (61.3%), or NYHA class III (37.1%) overall, while more patients in the S/V group showed NYHA class III (S/V: 42.8%, Non-S/V: 30.9%). Mean LVEF was slightly lower in the S/V group than in the Non-S/V group (S/V: 32.7%, Non-S/V: 35.4%, overall 34.0%). The most frequently observed signs of HF were dyspnoea upon effort, followed by fatigue, palpitations on exertion at baseline. More patients tend to have more severe symptoms in the S/V groups (e.g. for dyspnoea on effort, Non-S/V: moderate 40.8%, severe 8.6%; S/V: moderate 46.4%, severe 14.1%). 44.0% of patients from the S/V group and 39.3% of non-S/V patients reported at least one hospitalization within 12 months prior to baseline, of which 73.3% in S/V and 69.9% in non-S/V patients were due to HF., At baseline, 44.7% of the patients used a CV device, of which most were implantable cardioverter defibrillator (ICD: Non-S/V 54.2%, S/V: 52.8%), implantable cardioverter defibrillator (CRT-ICD:Non-S/V 21.9%, S/V: 27.0%), and pacemaker (Non-S/V: 13.4%, S/V: 10.5%). The mean KCCQ overall summary score was 62.6 in the S/V group and 69.5 in the Non-S/V group at baseline. 83.9% of patients were treated with ARB or ACEi in Non-S/V group, (ACEi 57.3%, ARB 26.9%). The most frequently taken drug combinations in either group were ACEi/ ARB or S/V with β -blockers (Non-S/V 69.3%, S/V 67.3%). 40.2% in the Non-S/V group and 42.9% in S/V groups used a combination of ACEi/ARB or S/V, β-blocker and MRA. Conclusions The ARIADNE prospective registry provides insights and reflects variations in HF treatment practices in outpatients in Europe and the way S/V was introduced by OBCs and specialized PCPs in a real-world setting. In the observed population, S/V is more often prescribed to slightly younger patients with slightly lower LVEF, there was a greater observed percentage of S/V patients NYHA class III, with lower quality of life measurements and with more severe symptoms and recent hospitalizations for heart failure. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Novartis Pharma AG


EP Europace ◽  
2003 ◽  
Vol 4 (Supplement_2) ◽  
pp. B105-B105
Author(s):  
M. Heinke ◽  
H. Kuhnert ◽  
R. Surber ◽  
G. Dannberg ◽  
H.R. Figulla ◽  
...  

Circulation ◽  
2007 ◽  
Vol 116 (suppl_16) ◽  
Author(s):  
Lynne W Stevenson ◽  
Yong K Cho ◽  
J. T Heywood ◽  
Robert C Bourge ◽  
William T Abraham ◽  
...  

Introduction : Elevated filling pressures are a hallmark of chronic heart failure. They can be reduced acutely during HF hospitalization but the hemodynamic impact of ongoing therapy to maintain optivolemia has not been established. Methods and Results : After recent HF hospitalization, 274 NYHA Class III or IV HF patients were enrolled in the COMPASS-HF study at 28 experienced HF centers and received intense HF management (average 24.7 staff contacts/ 6 months) ± access to filling pressure information to adjust diuretics to maintain optivolemia, usually defined as estimated pulmonary artery diastolic (PAD) pressure of 12±4 mmHg. Filling pressure information was available for half the patients during the first 6 months (the Chronicle group, <Access), and for all patients during the next 6 months. Diuretics were adjusted 12.7 times per patient in the Chronicle group and 8.2 times per patient in the Control (-Access) group during the first 6 months (p = 0.0001). Compared to baseline, decreases in RV systolic pressure (RVSP) and ePAD were significant for the +Access patients by one year (p=0.0012 and p =.04, respectively). The Control patients exhibited a similar trend 6 months after crossing to +Access (figure ). Conclusions: Targeted therapeutic adjustments, based on continuous filling pressures along with intensification of HF management contacts, are associated with a reduction in chronic left-sided filling pressures and right ventricular load.


Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Ethan J Rowin ◽  
Barry J Maron ◽  
Iacopo Olivotto ◽  
Susan A Casey ◽  
Anna Arretini ◽  
...  

Background: One-third of HCM patients without left ventricular outflow tract obstruction under resting conditions have the propensity to develop an outflow gradient with physiologic exercise. However, the natural history and management implications of exercise-induced (i.e., provocable) obstruction is unresolved. Methods: We prospectively studied 533 consecutive HCM patients without outflow obstruction at rest (<30mmHg) who underwent a symptom limiting stress (exercise) echocardiogram to assess development of outflow obstruction following physiologic provocation and followed for 6.5 ± 2.0 years. Of the 533 patients, obstruction ≥ 30 mmHg was present following exercise in 262 patients (49%; provocable obstruction), and was absent both at rest and with exercise in 271 (51%; nonobstructive). Results: Over the follow-up period, 43 out of 220 (20%) HCM patients with provocable obstruction and baseline NYHA class I/II symptoms developed progressive limiting heart failure symptoms to class III/IV, compared to 24 of 249 (10%) nonobstructive patients. Rate of heart failure progression was significantly greater in patients with provocable obstruction vs. nonobstructive patients (3.1%/year vs. 1.5%/year; RR=2.0, 95% CI of 1.3-3.2; p=0.003). However, the vast majority of patients with provocable obstruction who developed advanced heart failure symptoms achieved substantial improvement in symptoms to class I / II following relief of obstruction with invasive septal reduction therapy (n=30/32; 94%). In comparison, the majority of nonobstructive patients who developed advanced heart failure remained in class III/IV (16/24;67%), including 10 (42%) currently listed for heart transplant. Conclusions: Stress (exercise) echocardiogram identifies physiological provocable outflow tract obstruction in HCM, and is a predictor of future risk for progressive heart failure (3.1%/year), in patients who become candidates for invasive septal reduction therapy. Therefore, exercise echocardiography should be considered in all HCM patients without obstruction under resting conditions.


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