scholarly journals Survival Following Implantable Cardioverter‐Defibrillator Implantation in Patients With Amyloid Cardiomyopathy

2020 ◽  
Vol 9 (18) ◽  
Author(s):  
Angela Y. Higgins ◽  
Amarnath R. Annapureddy ◽  
Yongfei Wang ◽  
Karl E. Minges ◽  
Rachel Lampert ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Ventricular Tachycardia ◽  
Cerebrovascular Disease ◽  
Implantable Cardioverter Defibrillator ◽  
Cardiac Amyloidosis ◽  
Proportional Hazards ◽  
Cox Proportional Hazards ◽  
Icd Implantation ◽  
Cardioverter Defibrillator ◽  
Factors Associated

Background Outcomes data in patients with cardiac amyloidosis after implantable cardioverter‐defibrillator (ICD) implantation are limited. We compared outcomes of patients with ICDs implanted for cardiac amyloidosis versus nonischemic cardiomyopathies (NICMs) and evaluated factors associated with mortality among patients with cardiac amyloidosis. Methods and Results Using National Cardiovascular Data Registry’s ICD Registry data between April 1, 2010 and December 31, 2015, we created a 1:5 propensity‐matched cohort of patients implanted with ICDs with cardiac amyloidosis and NICM. We compared mortality between those with cardiac amyloidosis and matched patients with NICM using Kaplan‐Meier survival curves and Cox proportional hazards models. We also evaluated risk factors associated with 1‐year mortality in patients with cardiac amyloidosis using multivariable Cox proportional hazards regression models. Among 472 patients with cardiac amyloidosis and 2360 patients with propensity‐matched NICMs, 1‐year mortality was significantly higher in patients with cardiac amyloidosis compared with patients with NICMs (26.9% versus 11.3%, P <0.001). After adjustment for covariates, cardiac amyloidosis was associated with a significantly higher risk of all‐cause mortality (hazard ratio [HR], 1.80; 95% CI, 1.56–2.08). In a multivariable analysis of patients with cardiac amyloidosis, several factors were significantly associated with mortality: syncope (HR, 1.78; 95% CI, 1.22–2.59), ventricular tachycardia (HR, 1.65; 95% CI, 1.15–2.38), cerebrovascular disease (HR, 2.03; 95% CI, 1.28–3.23), diabetes mellitus (HR, 1.55; 95% CI, 1.05–2.27), creatinine = 1.6 to 2.5 g/dL (HR, 1.99; 95% CI, 1.32–3.02), and creatinine >2.5 (HR, 4.34; 95% CI, 2.72–6.93). Conclusions Mortality after ICD implantation is significantly higher in patients with cardiac amyloidosis than in patients with propensity‐matched NICMs. Factors associated with death among patients with cardiac amyloidosis include prior syncope, ventricular tachycardia, cerebrovascular disease, diabetes mellitus, and impaired renal function.

Worldwide differences in primary prevention implantable cardioverter defibrillator utilization and outcomes in hypertrophic cardiomyopathy

2021 ◽  
Author(s):  
Victor Nauffal ◽  
Peter Marstrand ◽  
Larry Han ◽  
Victoria N Parikh ◽  
Adam S Helms ◽  
...  
Keyword(s):  
Hypertrophic Cardiomyopathy ◽  
Primary Prevention ◽  
Implantable Cardioverter Defibrillator ◽  
Cox Proportional Hazards ◽  
Icd Implantation ◽  
Icd Therapy ◽  
Cardioverter Defibrillator ◽  
Significant Difference ◽  
Implantation Rates ◽  
The Impact

Abstract Aims  Risk stratification algorithms for sudden cardiac death (SCD) in hypertrophic cardiomyopathy (HCM) and regional differences in clinical practice have evolved over time. We sought to compare primary prevention implantable cardioverter defibrillator (ICD) implantation rates and associated clinical outcomes in US vs. non-US tertiary HCM centres within the international Sarcomeric Human Cardiomyopathy Registry. Methods and results We included patients with HCM enrolled from eight US sites (n = 2650) and five non-US (n = 2660) sites and used multivariable Cox-proportional hazards models to compare outcomes between sites. Primary prevention ICD implantation rates in US sites were two-fold higher than non-US sites (hazard ratio (HR) 2.27 [1.89–2.74]), including in individuals deemed at high 5-year SCD risk (≥6%) based on the HCM risk-SCD score (HR 3.27 [1.76–6.05]). US ICD recipients also had fewer traditional SCD risk factors. Among ICD recipients, rates of appropriate ICD therapy were significantly lower in US vs. non-US sites (HR 0.52 [0.28–0.97]). No significant difference was identified in the incidence of SCD/resuscitated cardiac arrest among non-recipients of ICDs in US vs. non-US sites (HR 1.21 [0.74–1.97]). Conclusion  Primary prevention ICDs are implanted more frequently in patients with HCM in US vs. non-US sites across the spectrum of SCD risk. There was a lower rate of appropriate ICD therapy in US sites, consistent with a lower-risk population, and no significant difference in SCD in US vs. non-US patients who did not receive an ICD. Further studies are needed to understand what drives malignant arrhythmias, optimize ICD allocation, and examine the impact of different ICD utilization strategies on long-term outcomes in HCM.

scholarly journals Absence of Obesity Paradox in All-Cause Mortality Among Chinese Patients With an Implantable Cardioverter Defibrillator: A Multicenter Cohort Study

2021 ◽  
Vol 8 ◽  
Author(s):  
Bin Zhou ◽  
Xuerong Sun ◽  
Na Yu ◽  
Shuang Zhao ◽  
Keping Chen ◽  
...  
Keyword(s):  
Implantable Cardioverter Defibrillator ◽  
Proportional Hazards ◽  
Obesity Paradox ◽  
Cox Proportional Hazards ◽  
Chinese Patients ◽  
Proportional Hazards Models ◽  
Cardioverter Defibrillator ◽  
Kaplan Meier ◽  
Cox Proportional Hazards Models ◽  
All Cause Mortality

Background: The results of studies on the obesity paradox in all-cause mortality are inconsistent in patients equipped with an implantable cardioverter-defibrillator (ICD). There is a lack of relevant studies on Chinese populations with large sample size. This study aimed to investigate whether the obesity paradox in all-cause mortality is present among the Chinese population with an ICD.Methods: We conducted a retrospective analysis of multicenter data from the Study of Home Monitoring System Safety and Efficacy in Cardiac Implantable Electronic Device–implanted Patients (SUMMIT) registry in China. The outcome was all-cause mortality. The Kaplan–Meier curves, Cox proportional hazards models, and smooth curve fitting were used to investigate the association between body mass index (BMI) and all-cause mortality.Results: After inclusion and exclusion criteria, 970 patients with an ICD were enrolled. After a median follow-up of 5 years (interquartile, 4.1–6.0 years), in 213 (22.0%) patients occurred all-cause mortality. According to the Kaplan–Meier curves and multivariate Cox proportional hazards models, BMI had no significant impact on all-cause mortality, whether as a continuous variable or a categorical variable classified by various BMI categorization criteria. The fully adjusted smoothed curve fit showed a linear relationship between BMI and all-cause mortality (p-value of 0.14 for the non-linearity test), with the curve showing no statistically significant association between BMI and all-cause mortality [per 1 kg/m2 increase in BMI, hazard ratio (HR) 0.97, 95% CI 0.93–1.02, p = 0.2644].Conclusions: The obesity paradox in all-cause mortality was absent in the Chinese patients with an ICD. Prospective studies are needed to further explore this phenomenon.

Abstract 86: Rates and Association of Risk Factors with Device Infection in Veterans Undergoing Cardioverter-Defibrillator Implantation Enrolled in the OVID Registry

2013 ◽  
Vol 6 (suppl_1) ◽  
Author(s):  
Preston M Schneider ◽  
David F Katz ◽  
Cara N Pelligrini ◽  
Paul A Heidenreich ◽  
Ryan G Aleong ◽  
...  
Keyword(s):  
Proportional Hazards ◽  
A Priori ◽  
Cox Proportional Hazards ◽  
Icd Implantation ◽  
Cardiac Device ◽  
Cardioverter Defibrillator ◽  
Increased Risk ◽  
Device Infection ◽  
Social Security Death Index

Introduction: Implanted cardiac device infections are a source of significant morbidity, mortality, and cost. The rates and predictors of device infection among patients undergoing implantable cardioverter defibrillator (ICD) implantation in the VA population have not been previously described. Methods: Among veterans enrolled in the Outcomes among Veterans with Implantable Defibrillators (OVID) registry between 2003 and 2009, 3,918 were identified as within 3 months of initial ICD implantation. Baseline clinical characteristics and clinical outcomes were abstracted from the electronic medical record and social security death index. The rates of device infection were calculated per 100 person years and a priori specified predictors of device infection were examined for association with device infection using Cox proportional hazards regression. Results: Over 11,290 person years of follow up, only 76 device infections were identified for a rate of 0.67 per 100 person years (95% CI 0.54 to 0.84). Among these, 21 (27.6%) occurred within 30 days of implantation, 19 (25.0%) occurred 30 to 90 days after implantation, 8 (10.5%) occurred 90 days to 1 year after implantation, and 28 occurred greater than 1 year after implantation. The most common type of infection was a pocket infection and it was most likely to occur within 30 days of implantation. Of the examined a priori specified predictors (age, generator change, diabetes mellitus, warfarin use, chronic kidney disease and congestive heart failure), only generator change was statistically significantly associated with device infection when adjusted for comorbidities (adjusted HR 2.95; 95% CI 1.42 - 6.12). The rate of device infection among those with a generator change was 1.26 per 100 person years compared to 0.60 per 100 person years for those without a generator change. Conclusions: The overall rate of device infection in this population is lower than previously published rates and only generator change was associated with an increased risk of device infection.

Abstract 16519: Meta-analysis of Outcome After Implantable Cardioverter Defibrillator Therapy in Patients With Cardiac Amyloidosis

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Sisir Siddamsetti ◽  
Mojgan Golzy ◽  
Sandeep Gautam
Keyword(s):  
Implantable Cardioverter Defibrillator ◽  
Cardiac Amyloidosis ◽  
Large Scale ◽  
Meta Analysis ◽  
Icd Implantation ◽  
Icd Therapy ◽  
Cardioverter Defibrillator ◽  
All Cause Mortality ◽  
Appropriate Therapy

Introduction: Cardiac amyloidosis is associated with high risk for sudden cardiac death. However, the potential benefit of implantable cardioverter defibrillator (ICD) implantation in CA is unknown due to limited available data regarding outcomes following ICD implantation in this patient population. We sought to perform a meta-analysis of trials that evaluated the outcomes of ICD implantation in CA. Methods: We performed a systematic literature review in PubMed, SCOPUS, and Cochrane to identify all studies that evaluated ICD therapy in CA until May 2020. Outcomes analyzed were all-cause mortality and appropriate ICD therapy rates. A random effects model was used to calculate percentages and 95% confidence intervals (CI) of outcomes. Results: Of the screened articles, 5 observational studies were included for analysis. A total of 151 patients were analyzed. Mean age of population was 61.6 +/- 0.7 years and 79.2% were male. The all-cause mortality rate was 33% (95% CI:16 to 51%) and the incidence of appropriate ICD therapy was 23% (95% CI:16 to 30%) over a mean follow up period of 16 months (Figure). In trials that evaluated ICD therapy in non-ischemic cardiomyopathy such as DANISH, DEFINITE and SCD-HeFT trials mortality rates in the ICD arm were 21.6 % over 67.6 months, 9.4% over 29 months and 16.7% over 45.5 months, respectively. The incidence of appropriate therapy in DANISH, DEFINITE and SCD-HeFT trials were 28.9%, 19.8 % and 21% respectively. Conclusions: CA patients with ICD have equivalent appropriate therapy with disproportionately higher mortality over a shorter follow up compared to randomized trials of primary prevention ICD placement in NICMP. The benefit of ICD placement for mortality reduction in CA remains unclear and further large-scale studies are required to address this issue.

Abstract 88: Preoperative Hyponatremia is Associated with Increased Risk of Heart Failure Hospitalization and Mortalityamong Veterans Undergoing Cardioverter-Defibrillator Implantation

2013 ◽  
Vol 6 (suppl_1) ◽  
Author(s):  
Preston M Schneider ◽  
David F Katz ◽  
Cara N Pelligrini ◽  
Paul A Heidenreich ◽  
Ryan G Aleong ◽  
...  
Keyword(s):  
Heart Failure ◽  
Risk Factor ◽  
Serum Sodium ◽  
Proportional Hazards ◽  
Multivariable Analysis ◽  
Cox Proportional Hazards ◽  
Heart Failure Hospitalization ◽  
Icd Implantation ◽  
Cardioverter Defibrillator ◽  
Increased Risk

Introduction: It is unknown whether hyponatremia is associated with risk of heart failure hospitalization or mortality among patients undergoing implantable cardioverter-defibrillator (ICD) implantation. This study was undertaken to assess whether or not hyponatremia is an independent risk factor for heart failure hospitalization or mortality following ICD implantation. Methods: The Outcomes among Veterans with Implantable Defibrillators (OVID) registry is a prospectively identified national cohort of VA patients who underwent ICD implantation between 2003 and 2009. There were 3,918 patients who were identified and having serum sodium measured at the time of implantation. Hyponatremia was the primary exposure and was defined by a serum sodium of less than 135 milliequivalents per liter (mEq/L). We assessed the association of hyponatremia with heart failure hospitalization and mortality using Cox proportional hazards regression adjusted for demographics, comorbidities, and type of device. Results: The mean serum sodium was 138.5 mEq/L and 579 patients (15.0%) had hyponatremia. Over a mean follow up time of 2.52 years, the rate of heart failure hospitalization was 14.1 per 100 person-years, and mortality was 9.6 per 100 person-years for subjects with hyponatremia at the time of implantation, compared to 10.0 per 100 person-years and 6.5 per 100 person-years, respectively, for those without hyponatremia. After multivariable analysis, hyponatremia at the time of implantation was associated with increased risk of both heart failure hospitalization (adjusted HR, 1.29; 95% CI, 1.06 - 1.57; P = 0.012) and mortality (adjusted HR, 1.31; 95% CI, 1.05 - 1.64; P = 0.016). Conclusions: Preoperative hyponatremia is associated with a modestly increased risk of both subsequent heart failure hospitalization and mortality among veterans undergoing ICD implantation. Further studies should assess whether hyponatremia at the time of ICD implantation is a modifiable risk factor that can be optimized or whether it is a representation of overall health status.

The Relationship of Diabetes Mellitus to Efficacy of Immune Checkpoint Inhibitors in Patients with Advanced Non-Small Cell Lung Cancer

Oncology ◽  
2021 ◽  
pp. 1-7
Author(s):  
Oded Jacobi ◽  
Yosef Landman ◽  
Daniel Reinhorn ◽  
Oded Icht ◽  
Michal Sternschuss ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Immune Checkpoint ◽  
Immune Checkpoint Inhibitors ◽  
Proportional Hazards ◽  
Checkpoint Inhibitors ◽  
Negative Relationship ◽  
Progression Free Survival ◽  
Significant Negative Correlation ◽  
Cox Proportional Hazards ◽  
Diabetic Patients

<b><i>Introduction:</i></b> Immune checkpoint inhibitors (ICI) are the new standard therapy in patients with metastatic NSCLC (mNSCLC). Metformin, previously associated with improved chemotherapy efficacy in diabetic and nondiabetic cancer patients, was recently associated with increased ICI efficacy. In this study, we aimed to explore the correlations between diabetes mellitus (DM), metformin use, and benefit from ICI in mNSCLC patients. <b><i>Methods:</i></b> All mNSCLC patients treated with ICI in our center between February 2015 and April 2018 were identified. Demographic and clinical data were extracted retrospectively. Cox proportional hazards regression, <i>t</i> tests, and χ<sup>2</sup> tests were employed to evaluate associations of progression-free survival (PFS), overall survival (OS), overall response rate (ORR), and disease control rate (DCR), with DM status, metformin use, and HbA1c levels, as appropriate. <b><i>Results:</i></b> Of 249 mNSCLC patients treated with ICI, 57 (22.8%) had DM. Thirty-seven (64.9% of all diabetic patients) patients were treated with metformin. A significant negative correlation of DM with PFS and OS was demonstrated (HR 1.5 [1.01–2.06], <i>p</i> = 0.011, and HR 1.5 [1.08–2.08], <i>p</i> = 0.017, respectively). Metformin exposure had no significant correlation with PFS or OS in diabetic mNSCLC patients (HR 1.08 [0.61–1.93], <i>p</i> = 0.79, and HR 1.29 [0.69–2.39], <i>p</i> = 0.42, respectively). There were no differences between groups with respect to ORR and DCR. <b><i>Conclusion:</i></b> Our data show a potential negative relationship between DM and ICI efficacy in mNSCLC patients. In contrast to reports with chemotherapy, we found no positive relationship between metformin use and ICI therapy in diabetic patients with mNSCLC. Further studies are needed to evaluate the effect of metformin in nondiabetic mNSCLC patients.

scholarly journals Trends and factors associated with modification or discontinuation of the initial antiretroviral regimen during the first year of treatment in the Turkish HIV-TR Cohort, 2011–2017

2021 ◽  
Vol 18 (1) ◽  
Author(s):  
Volkan Korten ◽  
◽  
Deniz Gökengin ◽  
Gülhan Eren ◽  
Taner Yıldırmak ◽  
...  
Keyword(s):  
Proportional Hazards ◽  
Virologic Failure ◽  
Risk Function ◽  
Transcriptase Inhibitor ◽  
Cox Proportional Hazards ◽  
Antiretroviral Drugs ◽  
Competing Risk ◽  
First Year ◽  
Strand Transfer ◽  
Factors Associated

Abstract Background There is limited evidence on the modification or stopping of antiretroviral therapy (ART) regimens, including novel antiretroviral drugs. The aim of this study was to evaluate the discontinuation of first ART before and after the availability of better tolerated and less complex regimens by comparing the frequency, reasons and associations with patient characteristics. Methods A total of 3019 ART-naive patients registered in the HIV-TR cohort who started ART between Jan 2011 and Feb 2017 were studied. Only the first modification within the first year of treatment for each patient was included in the analyses. Reasons were classified as listed in the coded form in the web-based database. Cumulative incidences were analysed using competing risk function and factors associated with discontinuation of the ART regimen were examined using Cox proportional hazards models and Fine-Gray competing risk regression models. Results The initial ART regimen was discontinued in 351 out of 3019 eligible patients (11.6%) within the first year. The main reason for discontinuation was intolerance/toxicity (45.0%), followed by treatment simplification (9.7%), patient willingness (7.4%), poor compliance (7.1%), prevention of future toxicities (6.0%), virologic failure (5.4%), and provider preference (5.4%). Non-nucleoside reverse transcriptase inhibitor (NNRTI)-based (aHR = 4.4, [95% CI 3.0–6.4]; p < 0.0001) or protease inhibitor (PI)-based regimens (aHR = 4.3, [95% CI 3.1–6.0]; p < 0.0001) relative to integrase strand transfer inhibitor (InSTI)-based regimens were significantly associated with ART discontinuation. ART initiated at a later period (2015-Feb 2017) (aHR = 0.6, [95% CI 0.4–0.9]; p < 0.0001) was less likely to be discontinued. A lower rate of treatment discontinuation for intolerance/toxicity was observed with InSTI-based regimens (2.0%) than with NNRTI- (6.6%) and PI-based regimens (7.5%) (p < 0.001). The percentage of patients who achieved HIV RNA < 200 copies/mL within 12 months of ART initiation was 91% in the ART discontinued group vs. 94% in the continued group (p > 0.05). Conclusion ART discontinuation due to intolerance/toxicity and virologic failure decreased over time. InSTI-based regimens were less likely to be discontinued than PI- and NNRTI-based ART.

scholarly journals Remote heart failure management using a multiparameter implantable cardioverter-defibrillator alert: the multicentric RE-HEART registry

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
J De Juan Baguda ◽  
J.J Gavira Gomez ◽  
M Pachon Iglesias ◽  
L Pena Conde ◽  
J.M Rubin Lopez ◽  
...  
Keyword(s):  
Heart Failure ◽  
Implantable Cardioverter Defibrillator ◽  
Median Duration ◽  
Office Visit ◽  
Active Phase ◽  
Cardiac Resynchronization ◽  
Office Visits ◽  
Icd Implantation ◽  
Cardioverter Defibrillator ◽  
Clinical Events

Abstract Background The HeartLogic algorithm combines multiple implantable cardioverter-defibrillator (ICD)-based sensors into an index for prediction of impending heart failure (HF) decompensation. In patients with ICD and cardiac resynchronization therapy ICD remotely monitored at 13 Spanish centers, we analyzed the association between clinical events and HeartLogic alerts and we described the use of the algorithm for the remote management of HF. Methods The association between clinical events and HeartLogic alerts was studied in the blinded phase (from ICD implantation to alert activation – no clinical actions taken in response to alerts) and in the following active phase (after alert activation – clinicians automatically notified in case of alert). Results We enrolled a total of 215 patients (67±13 years old, 77% male, 53% with ischemic cardiomyopathy) with ICD (19%) or CRT-D (81%). The median duration of the blinded phase was 8 [3–12] months. In this phase, the HeartLogic index crossed the threshold value (set by default to 16) 34 times in 20 patients. HeartLogic alerts were associated with 6 HF hospitalizations and 5 unplanned in-office visits for HF. Five additional HeartLogic threshold crossings were not associated with overt HF events, but occurred at the time of changes in drug therapy or of other clinical events. The rate of unexplained alerts was 0.25 alert-patient/year. The median time spent in alert was longer in the case of HF hospitalizations than of in-office visits (75 [min-max: 30–155] days versus 39 [min-max: 5–105] days). The maximum HeartLogic index value was 38±15 in the case of hospitalizations and 24±7 in that of minor HF events. The median duration of the following active phase was 5 [2–10] months. After HeartLogic activation, 40 alerts were reported in 26 patients. Twenty-seven (68%) alerts were associated with multiple HF- or non-HF related conditions or changes in prescribed HF therapy. Multiple actions were triggered by these alerts: HF hospitalization (4), unscheduled in-office visits (8), diuretics increase (8), change in other cardiovascular drugs (5), device reprogramming (2), atrial fibrillation ablation (1), patient education on therapy adherence (2). The rate of unexplained alerts not followed by any clinical action was 0.13 alert-patient/year. These alerts were managed remotely (device data review and phone contact), except for one alert that generated an unscheduled in-office visit. Conclusions HeartLogic index was frequently associated with HF-related clinical events. The activation of the associated alert allowed to remotely detect relevant clinical conditions and to implement clinical actions. The rate of unexplained alerts was low, and the work required in order to exclude any impending decompensation did not constitute a significant burden for the centers. Funding Acknowledgement Type of funding source: None

Sign in / Sign up

Export Citation Format

Share Document