scholarly journals One-center experience in leadless pacemakers after heart valve replacement

EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
JL Martinez-Sande ◽  
L Gonzalez ◽  
J Garcia-Seara ◽  
M Rodriguez-Manero ◽  
XA Fernandez-Lopez ◽  
...  
Keyword(s):  
Observational Study ◽  
Valve Replacement ◽  
Heart Valve ◽  
Surgical Procedure ◽  
Prospective Observational Study ◽  
Electrical Performance ◽  
Limited Information ◽  
Funding Sources ◽  
Funding Acknowledgements

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Leadless pacemakers (LPM) have demonstrated adequate electrical performance and safety in patients with multiple commorbidities. Limited information has been published about patients with LPM and heart valve replacements. Purpose We were interested to present our experience in patients with LPM and heart valve replacements. Methods This was a prospective observational study in which we include all consecutive LPM implantation in a 5 year period (June 1 2005 to January 1 2020). Clinical, electrical and echocardiographic characteristics were described and evaluated in 2 different groups with and with-out surgical procedure. Results A total of 242 LPM were implanted. We describe clinical and echocardiographic characteristics in patients table 1. There were no significant differences in electrical performance in between both groups (Figure 1). Conclusions In our series with LPM we observed adequate electrical performance as well as safety at implant and follow-up in patients with heart valve replacements. No valve procedure185Valve procedure61pAge79.2 (±6.4)79.7 (±8)0.6395Men114340.78866Hypertension151440.899914Diabetes Mellitus58190.635131COPD3470.345258Renal insufficiency29160.000717Ischemic cardiomiopathy36140.495789LVEF59.9 (±7.6)590.036577Single mechanical replacement18Single bioprosthetic replacement12Bioprosthetic valve + TV annuloplasty3Bioprosthetic valve + MV & TV annuloplasty1Mechanical valve + TV annuloplasty2Sigle MV annuloplasty1MV & TV annuloplasty2Abstract Figure.

scholarly journals Using Wearable Devices to Monitor Physical Activity in Patients Undergoing Aortic Valve Replacement: Protocol for a Prospective Observational Study

10.2196/20072 ◽  
2020 ◽  
Vol 9 (11) ◽  
pp. e20072
Author(s):  
Giulia Lorenzoni ◽  
Danila Azzolina ◽  
Chiara Fraccaro ◽  
Alessandro Di Liberti ◽  
Augusto D'Onofrio ◽  
...  
Keyword(s):  
Physical Activity ◽  
Aortic Valve ◽  
Observational Study ◽  
Aortic Valve Replacement ◽  
Physical Function ◽  
Valve Replacement ◽  
Prospective Observational Study ◽  
Wearable Devices ◽  
Postoperative Changes

Background In last few decades, several tools have been developed to measure physical function objectively; however, their use has not been well established in clinical practice. Objective This study aims to describe the preoperative physical function and to assess and compare 6-month postoperative changes in the physical function of patients undergoing treatment for aortic stenosis with either surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR). The study also aims to evaluate the feasibility of wearable devices in assessing physical function in such patients. Methods This is a prospective observational study. The enrollment will be conducted 1 month before patients’ SAVR/TAVR. Patients will be provided with the wearable device at baseline (activity tracker device, Garmin vívoactive 3). They will be trained in the use of the device, and they will be requested to wear it on the wrist of their preferred hand until 12 months after SAVR/TAVR. After baseline assessment, they will undergo 4 follow-up assessments at 1, 3, 6, and 12 months after SAVR/TAVR. At baseline and each follow-up, they will undergo a set of standard and validated tests to assess physical function, health-related quality of life, and sleep quality. Results The ethics committee of Vicenza in Veneto Region in Italy approved the study (Protocol No. 943; January 4, 2019). As of October 2020, the enrollment of participants is ongoing. Conclusions The use of the wearable devices for real-time monitoring of physical activity of patients undergoing aortic valve replacement is a promising opportunity for improving the clinical management and consequently, the health outcomes of such patients. Trial Registration Clinicaltrials.gov NCT03843320; https://tinyurl.com/yyareu5y International Registered Report Identifier (IRRID) DERR1-10.2196/20072

Using Wearable Devices to Monitor Physical Activity in Patients Undergoing Aortic Valve Replacement: Protocol for a Prospective Observational Study (Preprint)

2020 ◽  
Author(s):  
Giulia Lorenzoni ◽  
Danila Azzolina ◽  
Chiara Fraccaro ◽  
Alessandro Di Liberti ◽  
Augusto D'Onofrio ◽  
...  
Keyword(s):  
Physical Activity ◽  
Aortic Valve ◽  
Observational Study ◽  
Aortic Valve Replacement ◽  
Physical Function ◽  
Valve Replacement ◽  
Prospective Observational Study ◽  
Wearable Devices ◽  
Postoperative Changes

BACKGROUND In last few decades, several tools have been developed to measure physical function objectively; however, their use has not been well established in clinical practice. OBJECTIVE This study aims to describe the preoperative physical function and to assess and compare 6-month postoperative changes in the physical function of patients undergoing treatment for aortic stenosis with either surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR). The study also aims to evaluate the feasibility of wearable devices in assessing physical function in such patients. METHODS This is a prospective observational study. The enrollment will be conducted 1 month before patients’ SAVR/TAVR. Patients will be provided with the wearable device at baseline (activity tracker device, Garmin vívoactive 3). They will be trained in the use of the device, and they will be requested to wear it on the wrist of their preferred hand until 12 months after SAVR/TAVR. After baseline assessment, they will undergo 4 follow-up assessments at 1, 3, 6, and 12 months after SAVR/TAVR. At baseline and each follow-up, they will undergo a set of standard and validated tests to assess physical function, health-related quality of life, and sleep quality. RESULTS The ethics committee of Vicenza in Veneto Region in Italy approved the study (Protocol No. 943; January 4, 2019). As of October 2020, the enrollment of participants is ongoing. CONCLUSIONS The use of the wearable devices for real-time monitoring of physical activity of patients undergoing aortic valve replacement is a promising opportunity for improving the clinical management and consequently, the health outcomes of such patients. CLINICALTRIAL Clinicaltrials.gov NCT03843320; https://tinyurl.com/yyareu5y INTERNATIONAL REGISTERED REPORT DERR1-10.2196/20072

scholarly journals Safety of High-Dose Dabigatran in Elderly and Younger Patients with a Low Bleeding Risk: A Prospective Observational Study

Cardiology ◽  
2021 ◽  
pp. 1-5
Author(s):  
Aharon Erez ◽  
Gregory Golovchiner ◽  
Robert Klempfner ◽  
Ehud Kadmon ◽  
Gustavo Ruben Goldenberg ◽  
...  
Keyword(s):  
Observational Study ◽  
Elderly Patients ◽  
Prospective Observational Study ◽  
Bleeding Risk ◽  
The Elderly ◽  
High Dose ◽  
World Population ◽  
Younger Patients ◽  
End Point

<b><i>Introduction:</i></b> In patients with atrial fibrillation (AF) at risk for stroke, dabigatran 150 mg twice a day (DE150) is superior to warfarin for stroke prevention. However, there is paucity of data with respect to bleeding risk at this dose in elderly patients (≥75 years). We aimed to evaluate the safety of DE150 in comparison to warfarin in a real-world population with AF and low bleeding risk (HAS-BLED score ≤2). <b><i>Methods:</i></b> In this prospective observational study, 754 consecutive patients with AF and HAS-BLED score ≤2 were included. We compared outcome of elderly patients (age ≥75 tears) to younger patients (age &#x3c;75 years). The primary end point was the combined incidence of all-cause mortality, stroke, systemic emboli, and major bleeding event during a mean follow-up of 1 year. <b><i>Results:</i></b> There were 230 (30%) elderly patients, 151 patients were treated with warfarin, and 79 were treated with DE150. Fifty-two patients experienced the primary endpoint during the 1-year follow-up. Among the elderly, at 1-year of follow-up, the cumulative event rate of the combined endpoint in the DE150 and warfarin was 8.9 and 15.9% respectively (<i>p</i> = 0.14). After adjustment for age and gender, patients who were treated with DE150 had a nonsignificant difference in the risk for the combined end point as patients treated with warfarin both among the elderly and among the younger population (HR 0.58, 95% C.I = 0.25–1.39 and HR = 1.12, 95% C.I 0.62–2.00, respectively [<i>p</i> for age-group-by-treatment interaction = 0.83). <b><i>Conclusions:</i></b> Our results suggest that Dabigatran 150 mg twice a day can be safely used among elderly AF patients with low bleeding risk.

scholarly journals The role of rehabilitation measures in reintegration of children with brain tumours or leukaemia and their families after completion of cancer treatment: a study protocol

BMJ Open ◽  
2017 ◽  
Vol 7 (8) ◽  
pp. e014505 ◽  
Author(s):  
Mona Leandra Peikert ◽  
Laura Inhestern ◽  
Corinna Bergelt
Keyword(s):  
Observational Study ◽  
Cancer Treatment ◽  
Childhood Cancer ◽  
Quantitative Study ◽  
Prospective Observational Study ◽  
Daily Life ◽  
Oncological Rehabilitation ◽  
Rehabilitation Measures

IntroductionFor ill children as well as for their parents and siblings, childhood cancer poses a major challenge. Little is known about the reintegration into daily life of childhood cancer survivors and their families. The aim of this prospective observational study is to further the understanding of the role of rehabilitation measures in the reintegration process of childhood leukaemia or brain tumour survivors and their family members after the end of cancer treatment.Methods and analysisThis prospective observational study consists of three study arms: a quantitative study in cooperation with three German paediatric oncological study registries (study arm 1), a quantitative study in cooperation with a rehabilitation clinic that offers a family-oriented paediatric oncological rehabilitation programme (study arm 2) and a qualitative study at 12-month follow-up including families from the study arms 1 and 2 (study arm 3). In study arm 1, children, parents and siblings are surveyed after treatment (baseline), 4–6 months after baseline measurement and at 12-month follow-up. In study arm 2, data are collected at the beginning and at the end of the rehabilitation measure and at 12-month follow-up. Families are assessed with standardised questionnaires on quality of life, emotional and behavioural symptoms, depression, anxiety, fear of progression, coping and family functioning. Furthermore, self-developed items on rehabilitation aims and reintegration into daily life are used. Where applicable, users and non-users of rehabilitation measures will be compared regarding the outcome parameters. Longitudinal data will be analysed by means of multivariate analysis strategies. Reference values will be used for comparisons if applicable. Qualitative data will be analysed using thematic analysis.Ethics and disseminationThis study has been approved by the medical ethics committee of the Medical Chamber of Hamburg. Data will be published in peer-reviewed journals and presented at conferences.

scholarly journals Evaluation of Aetiology and Outcome of Acute Kidney Injury in a Tertiary Care Hospital of India- A Prospective Observational Study

2020 ◽  
Author(s):  
VS Gaurav Narayan ◽  
SG Ramya ◽  
Sonal Rajesh Kumar ◽  
SK Nellaiappa Ganesan
Keyword(s):  
Acute Kidney Injury ◽  
Intensive Care ◽  
Observational Study ◽  
Prospective Observational Study ◽  
Tertiary Care ◽  
Kidney Injury ◽  
Rapid Decline ◽  
Care Hospital ◽  
Medical Intensive Care

Introduction: The Acute Kidney Injury (AKI) is a rapid decline in renal filtration function. The aetiological spectrum, prevalence of AKI and outcome is highly variable. This variation exists due to the difference in the criteria used, study population and demographic features. Huge differences are noted when AKI is compared in developing and developed countries. Hence, it is important to analyse the spectrum of AKI to facilitate earlier diagnosis and treatment which shall help in improving the outcome. Aim: To study the prevalence, aetiology and outcome of AKI in the medical intensive care. Materials and Methods: This was a prospective observational study conducted in a medical intensive care for 18 months where 1490 patients were screened and 403 patients were included as AKI by KDIGO criteria. History, examination, appropriate investigations and treatment details including dialysis were noted. The serum creatinine levels were obtained every day, to know the time of onset of AKI, at the time of death or discharge, and after one month for patients who turned up for follow-up. Patients were categorised based on outcome as survivors and nonsurvivors. Survivors were divided into as fully recovered and partially recovered and those who left the Intensive Care Unit (ICU) against medical advice were termed as lost to follow-up. Results: A total of 403 patients (27.04% of 1490) of medical intensive care admissions were found to have AKI. Sepsis was the most common cause of AKI. At the end of the month, 78.4% of AKI patients fully recovered, 1.2% partially recovered and the mortality was 14.9%. Mortality was higher in AKI associated with chronic medical conditions like cardiac failure, chronic liver disease and stroke. Conclusion: If treated early, AKI is mostly reversible. Regional differences in AKI should be studied extensively and local guidelines should be formulated by experts for prevention and early treatment, to improve the disease outcome.

scholarly journals Electrocardiographic characteristics of patients with coronavirus disease 2019 (COVID-2019) related pneumonia at first presentation

EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
U Nguyen ◽  
M Strik ◽  
S Abu-Arib ◽  
A Bruekers ◽  
T Nguyen ◽  
...  
Keyword(s):  
Clinical Presentation ◽  
Negative Group ◽  
Male Mortality ◽  
Funding Sources ◽  
Atrial Enlargement ◽  
Study Population ◽  
Polymerase Chain ◽  
Repolarization Abnormalities ◽  
Funding Acknowledgements

Abstract Funding Acknowledgements Type of funding sources: None. Purpose To evaluate electrocardiographic (ECG) characteristics at first presentation in patients with possible coronavirus disease (COVID-19) pneumonia. Methods and results 356 patients presenting at the emergency room with possible COVID-19 pneumonia based on clinical presentation and computed tomography findings were included and subdivided into a COVID-19 positive group ([COVID-19-positive], n = 231, 65%) and a COVID-19 negative group ([COVID-19-negative], n = 125, 35%) based on polymerase chain reaction tests. The study population was predominantly middle aged-elderly (67 ± 14 year; n = 235, 66% male). Mortality rate was 24% after 1-month follow-up. There were no significant (NS) differences in sex, age, and mortality between the COVID-19-positive and COVID-19-negative group.  Atrial fibrillation (AF) was common (9%), though its prevalence was NS (regression analyses adjusted for age and sex) different in the COVID-19-positive vs. the COVID-19-negative group. ECG characteristics reflecting atrial enlargement and repolarization abnormalities were frequently present (&lt;38% and 14% respectively). No significant differences were found between the COVID-19-positive vs. the COVID-19-negative group for the majority of morphological ECG characteristics (Figure 1 for more detailed data).  Conclusion AF and ECG characteristics reflecting atrial enlargement and repolarization abnormalities are commonly present in COVID-19 patients. The prevalence of these ECG characteristics however do NS differ from their COVID-19-negative counterparts. Abstract Figure.

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