Abstract 17276: Implantable Cardioverter-Defibrillator Therapy in Women: Population-based Outomes

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Simone Cowan ◽  
Maja Grubisic ◽  
Lillian Ding ◽  
Nathaniel Hawkins ◽  
Adam Raymakers ◽  
...  

Background: Due to the low enrolment of women in implantable cardioverter-defibrillator (ICD) trials, there is controversy whether the survival benefit of ICDs applies to both sexes. Population-based data examining sex differences in ICD outcomes may provide further clarification. Methods: Study data were derived from a provincial registry in British Columbia (BC), the Cardiac Services BC Registry, where all ICD recipients are recorded. Patients ≥18 years with a new ICD implant from Jan 2003 to Dec 2012 were included. Data were linked to BC Vital Statistics to determine all-cause mortality. Survival was assessed using Kaplan-Meier methods stratified by sex and compared using the log-rank test. The Cox proportional-hazards model was used to estimate the hazard ratios (HR) and 95% confidence intervals (CI) between sexes. The effect of demographics, comorbidities and medication use were explored and only factors with a p-value < 0.15 were included in the final model. Statistical analyses were performed with SAS software, version 9.3 (Cary, NC). Results: There were 3905 new ICD implants; of these, 704 were women (18%). Women were younger and had a lower prevalence of comorbidities. Except for beta-blockers, women were less likely to be prescribed cardiac medications. The overall survival of women was greater than men; however, women had a higher re-operation rate for complications (Figure). After adjusting for age, diabetes, coronary artery disease, congestive cardiomyopathy, peripheral vascular disease, acquired heart surgery, and anti-arrhythmic drug use, the sex difference in mortality was attenuated, adjusted HR 0.91, (95% CI: 0.75,1.12). Conclusions: Women may derive the same survival benefit as men but have a higher re-operation rate for complications. Ongoing analyses will determine whether the impact of sex on mortality differs among patients receiving an ICD for primary versus secondary prevention.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 392-392
Author(s):  
Chan Shen ◽  
Ya-Chen T. Shih ◽  
Ying Xu ◽  
James C. Yao

392 Background: Octreotide long-acting repeatable (LAR) is approved for the management of symptoms due to carcinoid syndrome and may delay tumor progression among patients with neuroendocrine tumors (NETs). It is unknown whether dosage of octreotide LAR has an impact on survival. The current analysis evaluates the impact of initial octreotide LAR dosage on survival of elderly patients with NETs. Methods: Distant stage NET patients diagnosed between 1/1999 and 12/2009 who had received octreotide LAR treatment within 12 months of diagnosis were identified from the SEER-Medicare database. Those under age 65, enrolled in HMOs, or without continuous enrollment in Medicare Parts A and B were excluded. We compared the five-year survival of NET patients based on dose per 28 days averaged over the initial 3 months: Group A, <= 20 mg; B, 21 to 30 mg; C, > 30 mg. Kaplan-Meier estimations and Cox proportional hazard modeling were used to examine the association between octreotide LAR dose and survival. Results: Among 214 distant stage patients (mean and median age at 74 years old) with octreotide LAR treatment, 73 (34%) received <= 20 mg, 82 (38%) received 21 – 30 mg, while 59 (28%) received >30 mg. Median survival for patients who received low, medium and high dosage levels were 20.8 (95% CI: 13.2 – 31.5), 32.6 (95% CI: 20.5 – 51.1), and 36.3 (95% CI: 24.8 – N/A) months respectively. The log rank test had a p-value of 0.006. Multivariate analyses showed that higher octreotide LAR dosage levels were associated with significant survival improvement for distant stage patients. Compared to patients with the low dosage level, patients with medium dosage (HR=0.52, P=0.002) and patients with high dosage (HR=0.48, P=0.004) had better five-year survival. The difference in survival between Groups B and C was not statistically significant. Conclusions: This population-based study suggests potential survival benefits for octreotide LAR 30 mg dosage level among elderly distant stage NET patients.


2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e15012-e15012
Author(s):  
Jin Li ◽  
Shukui Qin ◽  
Yuxian Bai ◽  
Yanhong Deng ◽  
Lei Yang ◽  
...  

e15012 Background: In phase 3 FRESCO trial, fruquintinib demonstrated a statistically significant and clinically meaningful overall survival benefit in Chinese metastatic colorectal cancer (mCRC) patients. As a known adverse effect of vascular endothelial growth factor receptor (VEGFR) inhibitors, hand-foot skin reaction (HFSR) was commonly reported as a drug-related adverse event (AE) in fruquintinib group. This retrospective analysis explored whether HFSR in fruquintinib group is associated with survival benefit in FRESCO. Methods: This analysis used a subpopulation of intent-to-treat population who at least completed one cycle and entered cycle two of fruquintinib treatment. Patients randomized to receive fruquintinib 5 mg/day during the first 3 weeks of each 4-week cycle were divided into subgroups based on whether they reported HFSR. Overall survival (OS) and progression-free survival (PFS) were evaluated by Kaplan-Meier method. Hazard ratio (HR) was estimated through Cox proportional hazards model. P-value was generated from log-rank test. Results: Among a total of 255 fruquintinib-treated patients who at least completed one cycle and entered cycle two, 52% (n = 133) reported HFSR of any grade. The median time-to-onset of HFSR (any grade) was 21 days and approximate 75% patients reported HFSR after cycle two treatment completion. The baseline characteristics were well balanced between HFSR reported and non-reported subgroups. Patients who reported HFSR showed both OS and PFS benefit with statistical significant difference comparing with HFSR non-reported patients in fruquintinib group. Fruquintinib significantly decreased 43% death risk in HFSR reported patients and prolonged the median OS to 11.14 months in comparison with HFSR non-reported patients (median: 11.24 vs 7.54 months; HR = 0.57, 95% CI: 0.42-0.78; p < 0.001). Similarly, Patients reported HFSR had a significantly longer PFS than those who did not reported HFSR in the fruquintinib group (median: 5.49 vs 3.48 months; HR = 0.70, 95% CI: 0.54-0.91; p = 0.008). Conclusions: This post-hoc analysis indicates that patients who had HFSR had a greater survival benefit from fruquintinib in Chinese mCRC patients. Clinical trial information: NCT02314819 .


Circulation ◽  
2001 ◽  
Vol 104 (suppl 1) ◽  
pp. I-171-I-176 ◽  
Author(s):  
Sigrid E. Sandner ◽  
Georg Wieselthaler ◽  
Andreas Zuckermann ◽  
Shahrokh Taghavi ◽  
Herwig Schmidinger ◽  
...  

Author(s):  
Victor Nauffal ◽  
Peter Marstrand ◽  
Larry Han ◽  
Victoria N Parikh ◽  
Adam S Helms ◽  
...  

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.


2017 ◽  
Vol 16 (8) ◽  
pp. 742-752 ◽  
Author(s):  
Joanna Sweeting ◽  
Kylie Ball ◽  
Julie McGaughran ◽  
John Atherton ◽  
Christopher Semsarian ◽  
...  

Background: Physical activity is associated with improved quality of life. Patients with an implantable cardioverter defibrillator (ICD) face unique clinical and psychological challenges. Factors such as fear of ICD shock may negatively impact on physical activity, while a sense of protection gained from the ICD may instil confidence to be active. Aim: We aimed to examine the impact of an ICD on physical activity levels and factors associated with amount of activity. Methods: Two cross-sectional studies were conducted. Accelerometer data (seven-day) was collected in March–November 2015 for 63 consecutively recruited hypertrophic cardiomyopathy patients, with or without an ICD, aged ⩾18 years. A survey study was conducted in July–August 2016 of 155 individuals aged ⩾18 years with an inherited heart disease and an ICD in situ. Results: Based on the International Physical Activity Questionnaire, mean leisure time physical activity was 239 ± 300 min/week with 51% meeting physical activity guidelines. Accelerometry showed that mean moderate–vigorous physical activity was the same for patients with and without an ICD (254 ± 139 min/week versus 300 ± 150 min/week, p=0.23). Nearly half of survey participants ( n=73) said their device made them more confident to exercise. Being anxious about ICD shocks was the only factor associated with not meeting physical activity guidelines. Conclusions: Patients with inherited heart disease adjust differently to their ICD device, and for many it has no impact on physical activity. Discussion regarding the appropriate level of physical activity and potential barriers will ensure best possible outcomes in this unique patient group.


2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. A414-A414
Author(s):  
Ibrahim Naoum ◽  
Abedalghani Abedalhalim ◽  
Amir Aker ◽  
Luai Khalaili ◽  
Sameer Kassem

Abstract Background: Diabetes and chronic obstructive pulmonary disease (COPD) are widely prevalent and comorbidity with these diseases is quite common. However, there is limited data on the interrelation between glycemic control and COPD exacerbations in diabetic patients. Objective: To study the association between pre-admission glycemic control and COPD clinical outcomes including mortality, risk of hospital readmission and the need for mechanical ventilation. Methods: A retrospective population-based cohort study. We screened for patients with both diabetes and COPD exacerbation aged 35 years and above. Pre-admission glycemic control was defined by the last HBA1C level prior to hospitalization. Patients with HBA1C&gt;8% were defined as uncontrolled. We evaluated the difference between controlled and uncontrolled groups in the rates of mortality, readmission and the need for mechanical ventilation. We examined demographic and clinical parameters that might reflect COPD severity including: COPD medication use, blood hemoglobin, platelets, LDH and CRP levels. Results: 513 hospitalizations with diabetes and COPD were screened. 222 hospitalization were excluded either due to unestablished diagnosis of COPD or due to lack of HBA1C test in the preceding year. Of the remaining 291, 208 admissions were with controlled diabetes whereas 83 were uncontrolled. Although not statistically significant, the rate of re-hospitalization was higher in the uncontrolled group (OR 1.99, CI 0.99–4.0, p-value 0.051). There was no statistically significant difference in mortality (OR 1.6, CI 0.73–3.5, p-value 0.243). The use of oxygen and the need for noninvasive mechanical ventilation were significantly higher in the uncontrolled group (67.5% vs. 52.4%, p-value 0.019, 33.7% versus 18.8%, p-value 0.006, respectively). There was no significant difference in possible confounders tested between the groups. Conclusion: Uncontrolled diabetes may adversely affect patients with COPD exacerbation. Larger studies are needed to conclusively determine the impact of glycemic control on COPD morbidity and mortality.


2021 ◽  
Author(s):  
Ronja Löber-Handwerker ◽  
Katja Döring ◽  
Christoph Bock ◽  
Veit Rohde ◽  
Vesna Malinova

Abstract Purpose: Patients with inoperable glioblastoma (GBM) usually experience worse prognosis compared to those in whom gross total resection (GTR) is achievable. Considering the treatment duration and its side effects identification of patients with survival benefit from treatment is essential to guarantee the best achievable quality of life. The aim of this study was to evaluate the survival benefit from radio-chemotherapy and to identify clinical, molecular, and imaging parameters associated with better outcome in patients with biopsied GBMs. Methods: Consecutive patients with inoperable GBM, who underwent tumor biopsy at our department from 2005 to 2019 were retrospectively analyzed. All patients had histologically confirmed GBM and were followed up until death. The overall survival (OS) was calculated from date of diagnosis to date of death. Clinical, radiological and molecular predictors of OS were evaluated. Results: A total of 95 patients with biopsied primary GBM were enrolled in the study. The mean age was 64.3±13.2 years, 56.8 % (54/95) were male and 43.2 % (41/95) female. Mean OS in the entire cohort was 9 months. After stratification for adjuvant treatment a higher median OS was found in the group with adjuvant treatment (7 months, range 2-88) compared to the group without treatment (1 month, range 1-5) Log-rank test, p<0.0001.Conclusion: Patients with inoperable GBM undergoing biopsy indeed experience a very limited OS. Adjuvant treatment is associated with significantly longer OS compared to patients not receiving treatment and should be considered, especially in younger patients with good clinical condition at presentation.


Author(s):  
Agnieszka Mlynarska ◽  
Rafal Mlynarski ◽  
Izabella Uchmanowicz ◽  
Czeslaw Marcisz ◽  
Krzysztof S. Golba

Frailty syndrome may cause cognitive decline and increased sensitivity to stressors. This can result in an increased incidence of anxiety and depression, and thus, concerns about life with an implantable cardioverter defibrillator (ICD). The aim of the study was to assess the impact of frailty syndrome on the increase in the number of device-related concerns after the implantation of an ICD. Material and methods: The study sample was a group of 103 consecutive patients (85 M; aged 71.6 ± 8.2) with an implanted ICD. The ICD Concerns Questionnaire (ICDC) was used to analyze their concerns about life with an ICD, and the Tilburg Frailty Indicator scale (TFI) was used to diagnose frailty. Results: In the group of patients with an ICD implanted, 73% had recognized frailty (83.3% women, 74.1% men); the average point value was 6.55 ± 2.67. The total ICDC questionnaire score for the patients with an implanted cardioverter defibrillator was 34.06 ± 18.15. Patients with frailty syndrome had statistically (p = 0.039) higher scores (36.14 ± 17.08) compared to robust patients (27.56 ± 20.13). In the logistic regression analysis, the presence of frailty was strongly associated with the total questionnaire score (OR = 1.0265, p = 0.00426), the severity of the concerns (OR = 1.0417, p = 0.00451), and device-specific concerns (OR = 1.0982, p = 0.00424). Conclusion: Frailty syndrome occurs in about 80% of patients after ICD implantation. The presence of frailty syndrome was strongly associated with concerns about an implantable cardioverter defibrillator.


2014 ◽  
Vol 3 (1) ◽  
pp. 27-41 ◽  
Author(s):  
B.R. Purnima ◽  
N. Sriraam ◽  
U. Krishnaswamy ◽  
K. Radhika

Electroencephalogram (EEG) signals derived from polysomnography recordings play an important role in assessing the physiological and behavioral changes during onset of sleep. This paper suggests a spike rhythmicity based feature for discriminating the wake and sleep state. The polysomnography recordings are segmented into 1 second EEG patterns to ensure stationarity of the signal and four windowing scheme overlaps (0%, 50%, 60% and 75%)of EEG pattern are introduced to study the influence of the pre-processing procedure. The application of spike rhythmicity feature helps to estimate the number of spikes from the given pattern with a threshold of 25%.Then non parametric statistical analysis using Wilcoxon signed rank test is introduced to evaluate the impact of statistical measures such as mean, standard deviation, p-value and box-plot analysis under various conditions .The statistical test shows significant difference between wake and sleep with p<0.005 for the applied feature, thus demonstrating the efficiency of simple thresholding in distinguishing sleep and wake stage .


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