scholarly journals Impact of initial rhythm control with cryoballoon ablation versus drug therapy on atrial fibrillation recurrence and quality of life: results from the Cryo-FIRST study

EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
N Pavlovic ◽  
M Kuniss ◽  
V Velagic ◽  
JS Hermida ◽  
S Healey ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Atrial Fibrillation ◽  
Summary Score ◽  
Group Differences ◽  
Cryoballoon Ablation ◽  
First Line ◽  
Significant Group ◽  
Sf 36 ◽  
Af Recurrence

Abstract Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): Medtronic OnBehalf The Cryo-FIRST Investigators Background Cryoballoon ablation (CBA) as a first-line rhythm control strategy is superior to antiarrhythmic drugs (AADs) for preventing atrial arrhythmia recurrence; however, the impact of first-line CBA specifically on atrial fibrillation (AF) recurrence and quality of life (QoL) has not been well characterized. Purpose To compare AF recurrence and QoL following first-line CBA vs. AAD therapy in patients with paroxysmal AF within the CryoFIRST trial (NCT01803438). Methods Patients with recurrent symptomatic paroxysmal AF who had not been administered class I or III AAD therapy for >48 hours were enrolled at 18 sites in 9 countries. Patients were randomized (1:1) to CBA or AAD treatment (Class I or III). Subjects were followed by 7-day Holter at 1, 3, 6, 9, and 12 months. Time-to-first AF recurrence outside of a 90-day blanking period was estimated by Kaplan-Meier analysis.  QoL was evaluated using the Atrial Fibrillation Effect on Quality of Life (AFEQT) and 36-Item Short Form Health Survey (SF-36) v2 questionnaires. Results Of the 218 randomized subjects, 187 (86%) completed the 12-month follow-up. By intention-to-treat (ITT) analysis, freedom from AF after blanking was achieved in 86.6% in the CBA and 74.5% in the AAD group (p = 0.023).  There was no difference in the time-to-first serious adverse event between groups. In total, 84.3% of patients in the CBA vs. 75.0% of patients in the AAD arm had a clinically important improvement (≥5 points) in the AFEQT summary score.  The adjusted mean difference in the AFEQT summary score at 12 months was 9.9 points higher in the CBA group (95% CI: 5.5-14.2; P < 0.001).  All AFEQT subscale scores were more favorable in the CBA vs. AAD group at 12 months.  There were no significant group differences in any of the SF-36 health domain scores at 12 months in the ITT analysis.  In the per-protocol analysis, clinically important and significant group differences in favor of CBA were observed at 12 months for 3 of 8 SF-36 health domain scores (physical functioning, general health and social functioning). Conclusion CBA is superior to AAD for preventing AF recurrence and improving AF-specific QoL in patients with paroxysmal AF. AFEQT Scores at Baseline and 12 MonthsAFEQT Score, Mean ± Standard DeviationCBAAADAdjusted Mean Difference at 12 Months (CBA vs. AAD)p-valueBaseline12 MonthsBaseline12 MonthsDaily Activities65.3 ± 25.887.8 ± 17.161.0 ± 27.976.6 ± 25.48.9 (3.2-14.6)0.002Symptoms59.9 ± 24.888.8 ± 15.658.4 ± 25.280.9 ± 22.27.1 (1.5-12.7)0.014Treatment Concern59.9 ± 23.189.8 ± 14.060.4 ± 24.577.7 ± 22.212.7 (7.9-17.5)<0.001AFEQT, Atrial Fibrillation Effect on Quality of Life questionnaire. CBA, cryoballoon ablation. AAD antiarrhythmic drug.Abstract Figure. Freedom From Atrial Fibrillation

Abstract 13916: Quality of Life Measured in First-line Therapy for Paroxysmal Atrial Fibrillation: A Comparison Between Cryoballoon Catheter Ablation versus Antiarrhythmic Drug Therapy

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
NIkola Pavlovic ◽  
Malte Kuniss ◽  
Vedran Velagic ◽  
Jean-Sylvain Hermida ◽  
Stewart Healey ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Atrial Fibrillation ◽  
Catheter Ablation ◽  
Paroxysmal Atrial Fibrillation ◽  
First Line ◽  
Sf 36 ◽  
Treatment Naïve ◽  
Component Scores

Introduction: The Cryo-FIRST study (NCT01803438) demonstrated that pulmonary vein isolation (PVI) with cryoballoon catheter ablation (CA) is superior to antiarrhythmic drug (AAD) therapy as a first line treatment for the prevention of atrial arrhythmia recurrence in patients with paroxysmal atrial fibrillation (PAF). Earlier CA may also be beneficial for improving quality of life (QoL). Hypothesis: We hypothesized that PVI with cyroballoon CA is superior to AAD therapy for improving QoL in treatment naïve patients with PAF. Methods: Patients with symptomatic PAF free of heart disease who had not been administered AAD therapy for >48 hours were enrolled at 18 sites in 9 countries. Patients were randomized (1:1) to cryoballoon CA (Arctic Front Advance, Medtronic) or AAD therapy (Class IC or III). Subjects were followed at 1, 3, 6, 9, and 12 months. QoL was evaluated using the Atrial Fibrillation Effect on Quality of Life (AFEQT) and SF-36 v2 questionnaires. Health domains and component scores from the SF-36 were transformed to norm-based T scores. Mean adjusted differences between arms were compared at each follow-up. Results: Of the 218 patients randomized (age 52±13 years, 68% male) 86% completed the 12-month follow-up. Crossovers occurred in 9% of subjects (N=20, CA-to-AAD: N=1, AAD-to-CA: N=19). There were no group differences in baseline AFEQT or SF-36 scores. The mean AFEQT summary score was more favorable in the CA vs. AAD group at 12 months (88.9 vs. 78.1 points, respectively). The adjusted difference was 9.9 points (95%CI: 5.5-14.2; P < .0001, Figure). A significant adjusted mean difference favoring CA was observed for the SF-36 physical component score at months 3 (1.8 points, p=0.031) and 9 (2.0 points, p=0.018). No other differences were observed in the physical or mental component scores between groups. Conclusions: Cryoballoon CA was superior to AAD therapy for improving AF-specific QoL in treatment naïve patients with symptomatic PAF.

Quality of life measured in first-line therapy during the Cryo-FIRST study: a comparison between cryoballoon catheter ablation versus antiarrhythmic drug therapy

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
G.B Chierchia ◽  
N Pavlovic ◽  
V Velagic ◽  
J.S Hermida ◽  
S Healy ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Atrial Fibrillation ◽  
Drug Therapy ◽  
Catheter Ablation ◽  
Funding Source ◽  
Cryoballoon Ablation ◽  
First Line ◽  
Consensus Statements ◽  
Treatment Naïve

Abstract Background By consensus statements, catheter ablation is a recommended treatment for patients with symptomatic drug-refractory paroxysmal atrial fibrillation (AF), as patients try to alleviate the burdensome AF symptoms that reduce the Quality of Life (QoL). Yet, first-line treatment of symptomatic patients via catheter ablation prior to initiation of antiarrhythmic drugs (AADs) is only a reasonable alternative (Class IIa). Clearly, more clinical data is necessary that compares catheter ablation to AAD therapy in treatment naïve patients. Purpose The Cryo-FIRST trial was designed to compare AAD treatment against pulmonary vein isolation (PVI) while using a cryoballoon catheter (Arctic Front Advance; Medtronic, Inc.). This current data analysis examines the QoL endpoints when comparing AADs to cryoballoon ablation in patients with symptomatic treatment naïve paroxysmal AF. Methods This randomized multicenter trial enrolled 220 patients from 18 sites in 9 countries (Europe, Australia, and Latin America) in a prospective open-blinded endpoint study design. Patients had not been administered a class I or III AAD for longer than 48 hours for inclusion into the study. Subjects were randomized (1:1) into a cohort that was administered AAD therapy or a cohort that received PVI via cryoablation. The prespecified QoL endpoint at 12 months was measured using the Atrial Fibrillation Effect on Quality of Life (AFEQT) scores, and QoL recordings were taken at baseline, 1, 3, 6, 9, and 12 months following the index treatment. Results Of the 218 patients randomized (age 52±13 years, 68% male) 86% completed the 12-month follow-up. Crossovers occurred in 9% of subjects (N=20), including: 1 subject in the cryoablation arm and 19 subjects in the AAD arm. At 12 months, 86.5% of the patients in the cryoablation arm and 70.4% of the patients in the AAD arm where without symptoms (EHRA score 1). The mean AFEQT summary score was more favorable in the catheter ablation group compared to the drug therapy group at 12 months (88.9 vs. 78.1 points, respectively). The adjusted difference was 9.9 points (95% CI: 5.5–14.2; P&lt;0.0001). Conclusions Cryoballoon ablation resulted in a significant improvement in QoL at 12 months compared to AAD therapy in treatment naïve patients with first-line symptomatic paroxysmal AF. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Medtronic International Trading Sàrl

scholarly journals Effect of multimorbidity patterns on the decline in health-related quality of life: a nationwide prospective cohort study in Japan

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e047812
Author(s):  
Takuya Aoki ◽  
Shunichi Fukuhara ◽  
Yasuki Fujinuma ◽  
Yosuke Yamamoto
Keyword(s):  
Quality Of Life ◽  
Cohort Study ◽  
Clinical Outcomes ◽  
Prospective Cohort ◽  
Summary Score ◽  
Health Related Quality ◽  
Sf 36 ◽  
Related Quality ◽  
Health Related

ObjectivesLongitudinal studies, which consider multimorbidity patterns, are useful for better clarifying the effect of multimorbidity on health-related quality of life (HRQoL) and for identifying the target population with poorer clinical outcomes among patients with multimorbidity. This study aimed to examine the effects of different multimorbidity patterns on the decline in HRQoL.DesignNationwide prospective cohort study.SettingJapanese adult residents.ParticipantsResidents aged ≥50 years selected by the quota sampling method.Primary outcome measureClinically relevant decline in HRQoL was defined as a 0.50 SD (5-point) decrease in the 36-Item Short Form Health Survey (SF-36) component summary scores for 1 year.ResultsIn total, 1211 participants completed the follow-up survey. Among the multimorbidity patterns identified using confirmatory factor analysis, multivariable logistic regression analyses revealed that high cardiovascular/renal/metabolic and malignant/digestive/urologic pattern scores were significantly associated with the clinically relevant decline in SF-36 physical component summary score (adjusted OR (aOR)=1.25, 95% CI: 1.08 to 1.44 and aOR=1.28, 95% CI: 1.04 to 1.58, respectively). High cardiovascular/renal/metabolic pattern score was also significantly associated with the clinically relevant decline in SF-36 role/social component summary score (aOR=1.23, 95% CI: 1.06 to 1.42).ConclusionsOur study revealed that multimorbidity patterns have different effects on the clinically relevant decline in HRQoL for 1 year. These findings can be useful in identifying populations at high risk and with poor clinical outcomes among patients with chronic diseases and multimorbidity for efficient resource allocation.

EVALUATION OF QUALITY OF LIFE IN BRACHIAL PLEXUS INJURY PATIENTS AFTER RECONSTRUCTIVE SURGERY

Hand Surgery ◽  
2006 ◽  
Vol 11 (03) ◽  
pp. 103-107 ◽  
Author(s):  
Izuru Kitajima ◽  
Kazureru Doi ◽  
Yasunori Hattori ◽  
Semih Takka ◽  
Emmanuel Estrella
Keyword(s):  
Quality Of Life ◽  
Brachial Plexus ◽  
Upper Extremity ◽  
Brachial Plexus Injury ◽  
Short Form ◽  
Bodily Pain ◽  
Summary Score ◽  
Joint Function ◽  
Sf 36

To evaluate the subjective satisfaction of brachial plexus injury (BPI) patients after surgery based on the medical outcomes study 36-item short form health survey (SF-36) and to correlate their SF-36 scores with upper extremity functions. Four items were assessed statistically for 30 patients: SF-36 scores after BPI surgery were compared with Japanese standard scores; the correlation between SF-36 scores and objective joint functions; difference in SF-36 scores between each type of BPI; and influence of each joint function on the SF-36 scores. The SF-36 subscale: PF — physical functioning, RP — role-physical, BP — bodily pain, and the summary score PCS — physical component summary, were significantly inferior to the Japanese standard scores. SF-36 is more sensitive to shoulder joint function than to elbow and finger joint functions. Little correlation was found between SF-36 scores and objective evaluations of joint functions. Greater effort is needed to improve the quality of life (QOL) of BPI patients. This study showed that SF-36 is not sensitive enough to evaluate regional conditions. A region- or site-specific questionnaire is required to evaluate upper extremity surgery.

scholarly journals Are the Effects of Homeopathy Attributable to a Statistical Artefact? A Reanalysis of an Observational Study

2013 ◽  
Vol 2013 ◽  
pp. 1-7 ◽  
Author(s):  
Rainer Lüdtke ◽  
Stefan N. Willich ◽  
Thomas Ostermann
Keyword(s):  
Quality Of Life ◽  
Cohort Studies ◽  
Summary Score ◽  
Regression To The Mean ◽  
Sf 36 ◽  
The Mean ◽  
Component Scores ◽  
True Population ◽  
Respective Standard Deviation

Background. Cohort studies have reported that patients improve considerably after individualised homeopathic treatment. However, these results may be biased by regression to the mean (RTM).Objective. To evaluate whether the observed changes in previous cohort studies are due to RTM and to estimate RTM adjusted effects.Methods. SF-36 quality-of-life (QoL) data from a German cohort of 2827 chronically diseased adults treated by a homeopath were reanalysed by Mee and Chua’s modifiedt-test.Results. RTM adjusted effects, standardized by the respective standard deviation at baseline, were 0.12 (95% CI: 0.06–0.19,P<0.001) in the mental and 0.25 (0.22–0.28,P<0.001) in the physical summary score. Small-to-moderate effects were confirmed for the most individual diagnoses in physical, but not in mental component scores. Under the assumption that the true population mean equals the mean of all actually diseased patients, RTM adjusted effects were confirmed for both scores in most diagnoses.Conclusions. Changes in QoL after treatment by a homeopath are small but cannot be explained by RTM alone. As all analyses made conservative assumptions, true RTM adjusted effects are probably larger than presented.

Abstract P322: Health Status of Stable Patients With Obstructive or Non-Obstructive Coronary Artery Disease Compared With Healthy Controls

2011 ◽  
Vol 4 (suppl_1) ◽  
Author(s):  
Rosanna Tavella ◽  
Natalie Cutri ◽  
John F Beltrame
Keyword(s):  
Quality Of Life ◽  
Coronary Artery Disease ◽  
Chest Pain ◽  
Coronary Artery ◽  
Obstructive Coronary Artery Disease ◽  
Summary Score ◽  
Healthy Controls ◽  
Sf 36 ◽  
Artery Disease

BACKGROUND. Patients with chest pain and no evidence of obstructive coronary artery disease on angiography (NoCAD) are frequently considered not to have significant pathology and their symptoms trivialized. This study compared the health status of patients with NoCAD, obstructive coronary artery disease (CAD) and healthy subjects. METHOD. Patients undergoing angiography within the preceding 12 months for the investigation of chest pain were categorized as NoCAD or CAD on the basis of the angiographic findings and completed a health-related quality of life instrument, the Short Form-36 (SF-36). These were compared with a ‘healthy control’ group that were randomly selected from the electronic white pages and recruited if they had no self-reported history of cardiovascular disease. Cross sectional comparisons between the three groups were age adjusted and performed using liner regression. RESULTS. As shown in the table below, the healthy controls were significantly younger and therefore comparison of SF36 scores were age adjusted. All SF-36 sub-scales (except for bodily pain) and summary scores (see table ), were significantly lower in the CAD and NoCAD groups compared to the healthy controls. There were no differences in SF-36 scores between NoCAD and CAD. CONCLUSION. Compared with a healthy population, patients with stable CAD and NoCAD have significantly poorer quality of life asF-36. Future management strategies need to address the health outcomes in these patients. Healthy Controls (n = 3168) NoCAD (n = 320) CAD (n = 828) Age 52 ± 15 57 ± 12 * 62 ± 11 # SF-36: Physical Summary Score 49 ± 10 41 ± 11 * 41 ± 11 # SF-36: Mental Summary Score 51 ± 10 46 ± 11 * 46 ± 11 # * p <0.01 for healthy controls vs NoCAD, # p <0.01 for healthy controls vs CAD

Abstract 147: Impact of Risk Factor Modification in Improving Quality of Life and Arrhythmia Symptoms in Patients With Atrial Fibrillation

2018 ◽  
Vol 11 (suppl_1) ◽  
Author(s):  
Amaryah Yaeger ◽  
Nancy R Cash ◽  
Tara Parham ◽  
Rajeev Pathak ◽  
David S Frankel ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Atrial Fibrillation ◽  
Risk Factor ◽  
Improve Quality ◽  
Risk Factor Modification ◽  
Obstructive Sleep ◽  
Sf 36 ◽  
The Impact ◽  
Factor Modification

Objective: The desired goal of atrial fibrillation (AF) management is maintenance of sinus rhythm in order to improve quality of life (QoL) and arrhythmia symptoms (AS). Although obesity and obstructive sleep apnea (OSA) are known risk factors for development of AF, these remain inadequately treated. We report the impact of prospectively modifying these risk factors on QoL and AS in AF patients (pts). Methods: AF pts with obesity (body mass index (BMI) ≥30kg/m 2 ) and/or the need for OSA management (high-risk as per Berlin Questionnaire or untreated OSA) were voluntarily enrolled in a nurse-led risk factor modification (RFM) program at their arrhythmia clinic visit. RFM entailed patient education, lifestyle modification counseling, coordination of care with appropriate specialists, and longitudinal care management. Progress with weight loss (WL) and OSA treatment was monitored via monthly follow-up calls and/or downloads from continuous positive airway pressure (CPAP) units for up to 12 months. QoL and AS were determined with the SF-36 and AF Severity Scale (AFSS) respectively, and were assessed at baseline, 6 months, and 12 months. Student t-test and chi-square tests were used to compare continuous and dichotomous variables. Results: From 11/1/16 to 10/31/17, 252 pts (age 63±11 years; male=179; paroxysmal AF=126) were enrolled as follows: 189 for obesity and 93 for OSA. The mean WL was 2.7±3.8% from baseline and 78% (n=126 of 162 pts with available data) of enrolled obese patients achieved WL. Among 93 pts at risk for OSA, 70 completed sleep studies and 50 were identified with OSA. Majority of these patients (76%; n=38 of 50) started CPAP therapy and have remained full (57%; n=17 of 30 pts with available CPAP data) and partial (13%; n=4 of 30) users. Table shows that SF-36 and AFSS scores improved for most measures of QoL and AS from baseline to 6 months. Conclusion: Participation in a risk factor modification program targeting obesity and obstructive sleep apnea can improve quality of life and arrhythmia symptoms in patients with atrial fibrillation. The impact of this strategy on long-term maintenance of sinus rhythm remains to be determined.

Quality of Life in Automated and Continuous Ambulatory Peritoneal Dialysis

2011 ◽  
Vol 31 (2) ◽  
pp. 138-147 ◽  
Author(s):  
Wieneke M. Michels ◽  
Sandra Van Dijk ◽  
Marion Verduijn ◽  
Saskia Le Cessie ◽  
Elisabeth W. Boeschoten ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Peritoneal Dialysis ◽  
Kidney Disease ◽  
Continuous Ambulatory Peritoneal Dialysis ◽  
Short Form ◽  
Summary Score ◽  
Medical Outcomes ◽  
Sf 36 ◽  
Over Time

ObjectiveDespite a lack of strong evidence, automated peritoneal dialysis (APD) is often prescribed on account of an expected better quality of life (QoL) than that expected with continuous ambulatory peritoneal dialysis (CAPD). Our aim was to analyze differences in QoL in patients starting dialysis on APD or on CAPD with a follow-up of 3 years.MethodsAdult patients in the prospective NECOSAD cohort who started dialysis on APD or CAPD were included 3 months after the start of dialysis. The Medical Outcomes Survey Short Form 36 [SF-36 (Medical Outcomes Trust and QualityMetric, Lincoln, RI, USA)] and Kidney Disease and Quality of Life Short Form [KDQOL-SF (KDQOL Working Group, Santa Monica, CA, USA)] questionnaires were used to measure QoL. Differences in QoL over time were calculated using linear mixed models. Patients were followed until transplantation, death, or a first switch to any other dialysis modality.ResultsThe clinical and social characteristics of the 64 APD and 486 CAPD patients were slightly different at baseline. In the crude analysis, the pattern of the mental summary score differed between the modalities ( p = 0.03, adjusted p = 0.06), because of a different pattern for role function emotional ( p = 0.03, adjusted p = 0.05). The pattern of the physical summary score was not different between the groups. Scores on dialysis staff encouragement had a different pattern over time ( p = 0.01), because of an in-equality in scores 3 months after the start of dialysis, which disappeared after 18 months on dialysis. Over time, patients on APD scored higher on sexual function. After adjustment for age, sex, glomerular filtration rate, comorbidity, and primary kidney disease, that difference disappeared. This study showed no major differences in QoL on the KDQOL-SF and the SF-36 between the two modalities.

Patient characteristics and determinants of quality of life in an international population with multiple sclerosis: Assessment using the MusiQoL and SF-36 questionnaires

2011 ◽  
Vol 17 (10) ◽  
pp. 1238-1249 ◽  
Author(s):  
Oscar Fernández ◽  
Karine Baumstarck-Barrau ◽  
Marie-Claude Simeoni ◽  
Pascal Auquier ◽  
Keyword(s):  
Quality Of Life ◽  
Multiple Sclerosis ◽  
Short Form ◽  
Occupational Status ◽  
Mental Component Summary Score ◽  
International Study ◽  
Summary Score ◽  
Sf 36 ◽  
Edss Score

Background: Multiple sclerosis (MS) can have psychological and socioeconomic consequences that affect patients’ health-related quality of life (HRQoL) as much as physical disability. Objective: To determine the clinical and sociodemographic factors affecting HRQoL in a large international study using the MS International QoL (MusiQoL) questionnaire. Methods: Patients aged >18 years with a diagnosis of MS for >6 months or clinically isolated syndrome (CIS) were enrolled. Sociodemographic and clinical data were recorded, and patients completed the MusiQoL and 36-item short form (SF-36) health survey questionnaires. Results: In total, 1992 patients from 15 countries were enrolled (mean [standard deviation] age: 42.3 [12.5] years; 70.5% women; 70.4% with relapsing–remitting MS). Multivariate multiple regression analyses identified lower educational level, higher Expanded Disability Status Scale (EDSS) score, cognitive impairment, being single and shorter time since last relapse as significant predictors of lower MusiQoL global index scores ( p < 0.05). Older age, female sex, higher EDSS score, shorter time since last relapse and receiving current MS treatment were significant predictors of lower SF-36 physical component summary scores ( p < 0.05). The SF-36 mental component summary score was linked to occupational status, inpatient/outpatient status, time since last relapse, and whether the patient was receiving MS treatment ( p < 0.05). Conclusion: Sociodemographic and clinical factors are linked to HRQoL in patients with MS. Interventions that affect these factors might be expected to influence HRQoL.

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