2167Impact of dual-chamber pacing with closed loop stimulation on quality of life in patients with recurrent reflex vasovagal syncope: results from the SPAIN study

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
G Baron Esquivias ◽  
C M Morillo ◽  
A M Moya ◽  
J D Martinez Alday ◽  
R Ruiz-Granell ◽  
...  

Abstract Background Reflex vasovagal syncope (VVS) is one of the most common causes of syncope and, when recurrent, can have devastating consequences on the quality of life of patients despite pharmacological interventions. The closed loop stimulation (CLS) pacing algorithm converts, during an incipient VVS, variations in right intracardiac impedance into heart rate adaptation. The study SPAIN was the first randomized, double-blind trial robustly showing a strong reduction in syncopal recurrence in patients paced with dual-chamber (DDD)-CLS. (NCT01621464). Purpose To evaluate whether the differences observed in the SPAIN study regarding syncope burden and time to recurrence translate into improvements on quality of life. Methods This study analysed quality of life data from the SPAIN study: a randomized, prospective, double-blind, multicenter trial conducted in 10 Spanish and 1 Canadian centers. Ethics Committee approval was obtained at each participating center. Patients aged ≥40 years, with ≥5 VVS episodes and cardioinhibitory response to head-up tilt testing were included. After implant, patients were randomized 1:1 to active DDD-CLS mode for 12 months followed by sham DDI mode for the remaining 12 months or vice-versa. Quality of life was assessed via the Short Form-36 (SF-36) health survey before randomization (baseline), and at 12- and 24-month follow-up. The change in quality of life during the entire follow-up relative to baseline was compared between each pacing mode (DDD-CLS vs. DDI). Results Fifty-four patients were enrolled with a mean age of 56.3±10.6 years and a median of 12 syncopal episodes before randomization. Median SF-36 scores greatly increased from baseline in the DDD-CLS group across the 8 domains, whereas the response was variable in the DDI group. Comparing both pacing algorithms, median SF-36 scores were higher in the DDD-CLS group, with differences reaching statistical significance for “physical role” and “vitality” domains (p-value =0.006 and 0.014, respectively). Pacing sequence or treatment period did not significantly influence the response (p-value >0.05 for all the domains). Conclusions We demonstrated the beneficial effect of this physiological pacing algorithm on the quality of life of patients, as evidenced by the improvement in all the domains of the SF-36 when stimulated in DDD-CLS as compared to the sham DDI mode.

EP Europace ◽  
2019 ◽  
Vol 22 (2) ◽  
pp. 314-319 ◽  
Author(s):  
Gonzalo Barón-Esquivias ◽  
Angel Moya-Mitjans ◽  
Jesús Martinez-Alday ◽  
Ricardo Ruiz-Granell ◽  
Javier Lacunza-Ruiz ◽  
...  

Abstract Aims  Reflex vasovagal syncope (VVS) is the most common cause of syncope and patients with recurrent episodes may severely impair quality of life (QoL). This pre-specified analysis evaluated whether the clinically significant reduction in syncope burden demonstrated by dual-chamber pacing with closed loop stimulation (DDD-CLS) reported in the SPAIN trial translates into improved QoL. Methods and results Patients aged ≥40 years with ≥5 VVS episodes and cardioinhibitory response induced by head-up tilt testing were included. Patients were randomized 1:1 to active DDD-CLS pacing algorithm for 12 months followed by sham DDI mode for the remaining 12 months (Group A) or vice versa (Group B). QoL was assessed using the Short Form-36 (SF-36) health survey, Physical Component Score (PCS), and Mental Component Score (MCS) before randomization (baseline) and at 12- and 24-month follow-up. Fifty-four patients were enrolled from 11 participating centres. No significant carryover effect was detected for any variable, and the only period effect was observed in the vitality subdomain (P = 0.033). Mean SF-36 scores were higher in the DDD-CLS group vs. the DDI group for the eight subdomains and significantly different in physical role, bodily pain, and vitality (P < 0.05). The analysis of component summary scores indicated that DDD-CLS benefited both mental and physical components with significant differences in PCS when compared with the DDI group. Conclusion Dual-chamber pacing with closed loop stimulation determined a significant and clinically relevant improvement in QoL across both mental and physical components in patients with recurrent VVS. Registration Closed Loop Stimulation for Neuromediated Syncope (SPAIN Study); NCT01621464.


Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Renata de Barros e Silva ◽  
Denise Hachul ◽  
PEDRO GABRIEL M DE BARROS E SILVA ◽  
Mauricio I Scanavacca

Introduction: Vasovagal syncope presents a benign prognosis in terms of survival but is associated with significant impairment on quality of life (QoL). Poor emotional status contributes to the recurrence of events. Hypothesis: Among patients with recurrent vasovagal syncope, weekly sessions of psychotherapy may improve QoL and reduce the number of events during one year of follow-up. Methods: A randomized controlled trial was conducted including 10 patients with recurrent vasovagal syncope and positive tilt test. Cardiac disease and ongoing psychotherapeutic interventions were the main exclusion criteria. After randomization, half of the eligible patients underwent weekly sessions of psychotherapy during 12 months, while the control group was followed according to the standard of care, without psychotherapy. QoL by SF-36 and recurrence of syncope and pre-syncope were compared between the 2 groups and also in each group pre and post randomization. Results: All patients had a positive tilt test (80% with mixed vasovagal response), 70% were female and the mean age was 47.4 ± 11.1 years. The average rate of events before inclusion was 4.1 (± 3.4) syncopes/year and 1.26 (± 0.5) episodes of presyncope/week. The groups were well balanced at baseline and all patients completed the planned follow-up of one year. In the assessment of QoL by SF-36, comparing before and one year after randomization, there was no statistically significant difference in the control group (49.9 ± 9.8 vs 46.9 ± 3.4, P = 0.20) but there was a significant improvement in the intervention group (44.9 ± 11.9 vs 68.8 ± 7.8, P < 0.01). Comparing both groups at 12 months, patients that underwent sessions of psychotherapy had better QoL (68.8 ± 7.8 vs 46.9 ± 3.4, P < 0.01). Regarding the recurrence of syncope events, there was no significant change in the control group; however, in the intervention group there was a significant reduction in the rate of presyncope episodes per month (5.6 ± 2.1 vs 1.7 ± 0.9; P = 0.02) and also a significant reduction in the rate of syncope per year (4.6 ± 3.3 vs 1.0 ± 0.7; P = 0.04). Conclusions: In a randomized clinical trial, patients with recurrent vasovagal syncope undergoing regular psychotherapeutic intervention had less recurrence of events and improved quality of life in one year.


2019 ◽  
Vol 101-B (3) ◽  
pp. 272-280 ◽  
Author(s):  
F. G. M. Verspoor ◽  
M. J. L. Mastboom ◽  
G. Hannink ◽  
W. T. A. van der Graaf ◽  
M. A. J. van de Sande ◽  
...  

Aims The aim of this study was to evaluate health-related quality of life (HRQoL) and joint function in tenosynovial giant cell tumour (TGCT) patients before and after surgical treatment. Patients and Methods This prospective cohort study run in two Dutch referral centres assessed patient-reported outcome measures (PROMs; 36-Item Short-Form Health Survey (SF-36), visual analogue scale (VAS) for pain, and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)) in 359 consecutive patients with localized- and diffuse-type TGCT of large joints. Patients with recurrent disease (n = 121) and a wait-and-see policy (n = 32) were excluded. Collected data were analyzed at specified time intervals preoperatively (baseline) and/or postoperatively up to five years. Results A total of 206 TGCT patients, 108 localized- and 98 diffuse-type, were analyzed. Median age at diagnosis of localized- and diffuse-type was 41 years (interquartile range (IQR) 29 to 49) and 37 years (IQR 27 to 47), respectively. SF-36 analyses showed statistically significant and clinically relevant deteriorated preoperative and immediate postoperative scores compared with general Dutch population means, depending on subscale and TGCT subtype. After three to six months of follow-up, these scores improved to general population means and continued to be fairly stable over the following years. VAS scores, for both subtypes, showed no statistically significant or clinically relevant differences pre- or postoperatively. In diffuse-type patients, the improvement in median WOMAC score was statistically significant and clinically relevant preoperatively versus six to 24 months postoperatively, and remained up to five years’ follow-up. Conclusion Patients with TGCT report a better HRQoL and joint function after surgery. Pain scores, which vary hugely between patients and in patients over time, did not improve. A disease-specific PROM would help to decipher the impact of TGCT on patients’ daily life and functioning in more detail. Cite this article: Bone Joint J 2019;101-B:272–280.


Author(s):  
Paulo Fávio Macedo Gouvêa ◽  
Zélia Maria Nogueira Britschka ◽  
Cristina de Oliveira Massoco Salles Gomes ◽  
Nicolle Gilda Teixeira de Queiroz ◽  
Pablo Antonio Vásquez Salvador ◽  
...  

This study aimed to evaluate the effects of treatment with Peruíbe Black Mud (PBM) on the clinical parameters and quality of life of patients with knee osteoarthritis and to compare the effects of PBM samples simply matured in seawater and PBM sterilized by gamma radiation. A controlled, double-blind trial was conducted with 41 patients divided into two treatment groups composed of 20 and 21 patients: one group was treated with matured PBM and the other with sterilized PBM. Evaluations were done using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the Medical Outcomes Study Short Form 36 (SF-36) questionnaires, the Kellgren and Lawrence (KL) radiographic scale, and the quantification of the serum levels of inflammatory biomarkers. An improvement in pain, physical functions, and quality of life was observed in all of the patients who underwent treatment with both simply matured and sterilized PBM. Nine patients showed remission in the KL radiographic scale, but no statistically significant differences were observed in the serum levels of inflammatory mediators before or after treatment. Peruíbe Black Mud proves to be a useful tool as an adjuvant treatment for knee osteoarthritis (OA), as shown by the results of the WOMAC and SF-36 questionnaires and by the remission of the radiographic grade of some patients on the Kellgren and Lawrence scale.


2021 ◽  
Author(s):  
Rose K Sia ◽  
Denise S Ryan ◽  
Daniel I Brooks ◽  
Janice M Kagemann ◽  
Kraig S Bower ◽  
...  

ABSTRACT Purpose The purpose of this study was to assess visual and health-related quality of life (QOL) among U.S. military service members who sustained combat ocular trauma (COT) with or without associated traumatic brain injury (TBI). Methods This was a single-center, prospective observational study of U.S. service members (n = 88) with COT who were treated at Walter Reed National Military Medical Center. Participants completed the National Eye Institute Visual Function Questionnaire (VFQ-25) at enrollment and at follow-up (&gt;1 year) and supplemental surveys: Neurobehavioral Symptom Inventory, the Medical Outcomes 36-item Short Form Survey (SF-36), and Mayo-Portland Adaptability Inventory. Results Initial and follow-up VFQ-25 showed a statistically significant increase in median scores for near activities (initial: 75.0, follow-up 83.3; P = .004) and peripheral vision (initial: 50.0, follow-up: 75.0; P = .009) and in composite scores (initial: 79.5, follow-up: 79.8; P = .022). Comparing those who did (n = 78) and did not (n = 8) have a TBI history, there were no significant differences in median change in VFQ-25 composite scores (with TBI: 2.3 vs. no TBI: 10.7; P = .179). Participants with a TBI history had a significantly lower median SF-36 General Health score (with TBI: 67.5 vs. no TBI: 92.5; P = .009) Conclusions Vision-related QOL of COT patients is generally good in the long term. However, those with both COT and a history of TBI conditions showed significantly worse functioning in several domains than those without TBI. As TBI is a common finding in COT, this association is an important factor impacting this population’s overall clinical presentation and daily functions.


PLoS ONE ◽  
2021 ◽  
Vol 16 (10) ◽  
pp. e0257981
Author(s):  
Jung-Hwa Ryu ◽  
Tai Yeon Koo ◽  
Han Ro ◽  
Jang-Hee Cho ◽  
Myung-Gyu Kim ◽  
...  

Renal functional deterioration is associated with physical and mental burdens for kidney transplant (KT) and chronic kidney disease (CKD) patients. However, the change in health-related quality of life (HRQOL) over time in KT patients compared to that of native CKD patients has not been evaluated. We addressed this issue using KT patients registered in the KNOW-KT cohort study and patients at CKD stage 1–3 registered in the KNOW-CKD cohort study. HRQOL scores were assessed using the Kidney Disease Quality of Life Short Form at baseline, 2-, and 4-years follow-up in 842 KT patients and at baseline and 5-year follow-up in 1,355 CKD patients. SF-36 scores declined at the 4-year follow-up, whereas CKD-targeted scores showed no change in the KT group. In contrast, CKD-targeted scores as well as SF-36 scores were decreased at the 5-year follow-up in CKD patients. When prognostic factors were analyzed for longitudinal HRQOL data over time, renal functions, diabetes, cardiovascular and cerebrovascular diseases, hemoglobin level, marital status, income, employment, and health care were significant prognostic factors. Furthermore, KT was an independent prognostic factor for better HRQOL. These results highlight that KT can offer a better HRQOL than that of CKD patients, even when renal function is similar.


2021 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
F Bianco ◽  
M Colaneri ◽  
V Bucciarelli ◽  
FC Surace ◽  
FC Iezzi ◽  
...  

Abstract Funding Acknowledgements Type of funding sources: None. Background  To compare long-term outcomes of aortic valve repair (AVr) and pulmonary autograft replacement (Ross procedure) in terms of echocardiographic parameters, quality of life (QoL), physical activity (PA). Methods  In 2005-19, 129 patients (median age 22 [13, 33 IQR], 75% males) underwent aortic surgery in our Department: 40 were Ross (22 years [19, 51 IQR]), 67 AVr (17 years [1, 50 IQR]) and 22 aortic valve replacements (52 years [30, 80 IQR]). We focused on Ross and AVr. Retrospectively, relevant data were collected from medical records and phone re-calls. Physical activity (spontaneous and active) and QoL were assessed utilizing the IPAQ and SF-36 questionnaires. All patients underwent echocardiography pre/post-surgery and the follow-up lasted 12 ± 4 years. Results  At the baseline, Ross patients had more aortic stenosis than insufficiency (P = 0.045). At the follow-up, Ross procedures presented more right-ventricle and aortic annulus dilatation (P = 0.002 and P = 0.030, respectively), but higher left-ventricular global longitudinal strain (LV GLS: 18 ± 3.2 % vs. 16 ± 3.3, P = 0.0027). Conversely, AVr experienced more re-do operations (Log-rank P = 0.005). Ross reported better QoL (SF-36: 0.8 ± 0.07 vs. 19 ± 0.4, P-0.045) and were also more active in daily PA (IPAQ ≥ 2500 Mets: 63.8% vs. 6%; P = 0.006). Ross patients practiced more sports activities than AVr (P = 0.011). Conclusions  In a relatively small cohort of young and adults post aortic surgery patients, Ross procedures had better prognosis in terms of re-do operations; presented better ventricular function, as assessed by LV GLS. Ross patients had better long-term QoL and showed more spontaneous PA and involvement in sports activity.


Circulation ◽  
2015 ◽  
Vol 131 (suppl_1) ◽  
Author(s):  
Christina L Wassel ◽  
Matthew A Allison ◽  
Joachim H Ix ◽  
Julie O Denenberg ◽  
Dena E Rifkin ◽  
...  

Background: Lower extremity peripheral artery disease (PAD) affects approximately 9 million people in the US. Less well-recognized is that PAD, even when asymptomatic, is associated with decreased functional status and quality of life. Previous studies have largely examined associations of the ankle brachial index (ABI) and quality of life in participants with PAD. To our knowledge no studies have examined the impact of ABI and change in ABI on change in quality of life in a population-based setting. Methods: The SDPS is a population-based prospective study that evaluated non-Hispanic White, African-American, Hispanic and Asian men and women for lower extremity PAD at two examinations approximately 11 years apart. Participants completed the SF-36 questionnaire, and 802 participants had ABI and SF-36 data available at both examinations. Analyses were restricted to these participants who also had a baseline ABI<1.4. Growth curve models were used to assess the associations of baseline ABI and change in the ABI with change in the SF-36 physical component score (PCS) and mental component score (MCS) over time. Change in the ABI was defined as (follow-up ABI - baseline ABI)/baseline ABI. Results: Participants were on average 57±9 years of age at baseline, and 69±9 at follow-up. At baseline, nearly 2 percent had ABI≤0.90, and the mean±SD ABI was 1.12±0.10. After adjustment for age, sex, race/ethnicity, BMI, ever smoking, physical activity, hypertension, diabetes, and dyslipidemia, each SD lower baseline ABI was significantly associated with an average change of -0.63 points (95% CI (-0.10, -1.17), p=0.02) on the PCS. This association was marginally significant for the MCS (-0.54 points (0.14, 1.22), p=0.12). Lower baseline ABI was also associated with negative change in two SF-36 subscales, physical functioning (p=0.02) and vitality (p=0.01). Change in the ABI over 11 years was not associated with change in the MCS (p=0.97) or PCS (p=0.41). Results were similar when excluding participants with ABI≤0.90. Conclusions: A lower ABI at baseline is associated with a significantly worse physical functioning quality of life approximately 11 years later. However change in the ABI was not significantly associated with change in quality of life over this time period. Additional studies are warranted in larger samples, especially to confirm the lack of findings for change in ABI.


2021 ◽  
Vol 23 (Supplement_2) ◽  
pp. ii12-ii13
Author(s):  
S M Keshwara ◽  
A I Islim ◽  
C P Millward ◽  
C S Gillespie ◽  
G E Richardson ◽  
...  

Abstract BACKGROUND Long-term Health-Related Quality of Life (HRQoL) is an important measure of patient wellbeing. There is a paucity of studies evaluating HRQoL in meningioma patients. MATERIAL AND METHODS Cross-sectional study of adult patients with an incidental or symptomatic intracranial meningioma. Patients with less than 5 years of follow-up, a history of craniospinal radiation or neurofibromatosis type 2 were excluded. HRQoL was evaluated with SF-36, EORTC QLQ-C30 and EORTC QLQ-BN20 questionnaires. Outcome determinants were evaluated using a multi-variable linear regression analysis, adjusted for patient, tumour and treatment characteristics, and duration of follow-up. RESULTS 699 patients were invited to participate and 246 responded: 118 (48%) had an incidental meningioma. Mean age at diagnosis was 56.8 years (SD=13) and 81% were female. Median time from diagnosis to completion of questionnaire was 8.5 years (IQR 6.8–11.5). During follow-up, 158 patients (64.2%) had at least one operation for their meningioma and 47 patients (19.1%) had radiotherapy. Of those operated, 126 (79.7%) had WHO grade 1 and 24 (15.2%) had grade 2 meningiomas. Compared to normative population values, meningioma patients reported a worse SF-36 general health score (mean 61.9 vs 56.5, P=0.003) but a similar QLQ-C30 global health score (mean 62.3 vs 65.8, P=0.039), worse SF-36 and QLQ-C30 physical functioning scores (mean 74.1 vs 64.6, P&lt;0.001 and mean 81.8 vs 76.5, P=0.007) and similar SF-36 and QLQ-C30 emotional health scores (mean 72.2 vs 70.9, P=0.367 and mean 71.0 vs 71.9, P=0.960). QLQ-C30 cognitive functioning was worse (mean 80.5 vs 71.4, P&lt;0.001). Compared to the meningioma literature, QLQ-BN20 seizure burden was similar (mean 2.0 vs 1.6, P=0.760). A worse performance status at diagnosis was associated with an inferior QLQ-C30 global health score (β-coefficient=-4.9 [95% CI -9.1-(-)0.6] P=0.024). Number of surgeries was significantly associated with a worse QLQ-C30 cognitive functioning score (β-coefficient=-7.0 [95% CI -13.2-(-)0.9], P=0.025). Anti-epileptic drug use was associated with a significantly worse QLQ-C30 emotional health score (β-coefficient=-10.9 [95% CI -21.7-(-)0.01], P=0.050). CONCLUSION Meningioma patients have long-term HRQoL impairments affecting their physical and cognitive functions. An understanding that multiple surgeries affects cognitive function, and the need for anti-epileptic drugs equate to poorer emotional health, could help target appropriate therapies and support in the future.


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