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 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

scholarly journals Serial Changes in Cardiac Sympathetic Nervous Function After Transcatheter Aortic Valve Replacement: A Prospective Observational Study Using 123I-meta-iodobenzylguanidine Imaging

2021 ◽  
Author(s):  
Yoshito Kadoya ◽  
Kan Zen ◽  
Nagara Tamaki ◽  
Shunsuke Nakamura ◽  
Tomoki Fujimoto ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Observational Study ◽  
Aortic Valve Replacement ◽  
Valve Replacement ◽  
Transcatheter Aortic Valve Replacement ◽  
Prospective Observational Study ◽  
Mibg Imaging ◽  
Transcatheter Aortic Valve ◽  
Nervous Function ◽  
Sympathetic Nervous

Abstract Purpose:Transcatheter aortic valve replacement (TAVR) can rapidly improve cardiac sympathetic nervous function (CSNF) within 2 weeks in patients with aortic stenosis (AS). However, it remains unclear whether such short-term improvements will be sustained thereafter. The present study aimed to investigate the mid-term (i.e., 6–12 months) effects of TAVR on CSNF in patients with severe AS using 123I-meta-iodobenzylguanidine (MIBG) imaging.Methods:Patients with severe AS who were scheduled to undergo TAVR between October 2017 and June 2019 were enrolled in this single-centre, prospective, observational study. MIBG imaging was performed at baseline, within 2 weeks after TAVR, and at 6–12 months post-TAVR to evaluate the heart–mediastinum ratio (H/M) and washout rate (WR). Differences between each MIBG parameter at three time points were analysed, and factors involved in the long-term improvement in the late H/M were investigated. Results:Of 183 consecutive patients, 75 (19 men; median age: 86 years) were evaluated. The late H/M significantly improved within 2 weeks after TAVR (P=0.041) and further improved over 6–12 months after TAVR (P=0.041). The WR rapidly improved immediately after TAVR (P=0.003) but remained unchanged at 6–12 months (P=0.827). Multivariate analysis revealed that the baseline mean aortic valve pressure gradient (mPG) was an independent predictor of mid-term improvement in the late H/M (>0.1) (adjusted odds ratio: 0.035; 95% confidence interval: 0.004–0.070; P=0.037). Patients with a high baseline mPG (≥58 mmHg) exhibited a significantly greater increase in the late H/M than those with a low baseline mPG (<42 mmHg) (0.24 vs. 0.01; P=0.029).Conclusions:CSNF, as denoted by the late H/M, demonstrated sustained improvement from within 2 weeks after TAVR until 6–12 months later. Such improvement was related to baseline hemodynamic AS severity.

Minimally Invasive Transaortic Repair of the Mitral Valve

2011 ◽  
Vol 14 (4) ◽  
pp. 232 ◽  
Author(s):  
Orlando Santana ◽  
Joseph Lamelas
Keyword(s):  
Mitral Valve ◽  
Aortic Valve ◽  
Mitral Regurgitation ◽  
Aortic Valve Replacement ◽  
Minimally Invasive ◽  
Valve Replacement ◽  
Operative Mortality ◽  
The Mean ◽  
Transaortic Approach

<p><b>Objective:</b> We retrospectively evaluated the results of an edge-to-edge repair (Alfieri stitch) of the mitral valve performed via a transaortic approach in patients who were undergoing minimally invasive aortic valve replacement.</p><p><b>Methods:</b> From January 2010 to September 2010, 6 patients underwent minimally invasive edge-to-edge repair of the mitral valve via a transaortic approach with concomitant aortic valve replacement. The patients were considered to be candidates for this procedure if they were deemed by the surgeon to be high-risk for a double valve procedure and if on preoperative transesophageal echocardiogram the mitral regurgitation jet originated from the middle portion (A2/P2 segments) of the mitral valve.</p><p><b>Results:</b> There was no operative mortality. Mean cardiopulmonary bypass time was 137 minutes, and mean cross-clamp time was 111 minutes. There was a significant improvement in the mean mitral regurgitation grade, with a mean of 3.8 preoperatively and 0.8 postoperatively. The ejection fraction remained stable, with mean preoperative and postoperative ejection fractions of 43.3% and 47.5%, respectively. Follow-up transthoracic echocardiograms obtained at a mean of 33 days postoperatively (range, 8-108 days) showed no significant worsening of mitral regurgitation.</p><p><b>Conclusion:</b> Transaortic repair of the mitral valve is feasible in patients undergoing minimally invasive aortic valve replacement.</p>

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