scholarly journals Handling of remote monitoring alerts according to the weekday of transmission: results from the OptiLink HF study

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
J Wintrich ◽  
V.P Pavlicek ◽  
J.B Brachmann ◽  
R.B Bosch ◽  
C.B Butter ◽  
...  
Keyword(s):  
Remote Monitoring ◽  
Medical Intervention ◽  
Pharmacological Intervention ◽  
Funding Source ◽  
Patient Contact ◽  
Telephone Contact ◽  
Secondary Endpoints ◽  
Monitoring Service ◽  
Subsequent Patient

Abstract Background Remote monitoring of patients suffering from heart failure (HF) did not result in improved clinical outcomes in the OptiLink-HF trial. However, initiation of medical intervention after transmission of telemedicine alerts triggered by fluid index threshold crossings (FTCs) was low. The relation between weekday of transmission of FTC and subsequent patient contact is unknown. Methods Patients enrolled in the intervention arm of the OptiLink HF trial (n=505, age 66.1±10.1, male 77.2, EF 26.7±6.1%) were analyzed according to the weekday of transmission of FTC. Transmissions of FTC on Mondays to Thursdays were categorized as TD1, Fridays to Sundays as well as bank holidays as TD2. Primary endpoint was time between transmission and telephone contact; secondary endpoints were subsequent medical intervention and hospitalizations. Results During a follow-up of 18 months, 1364 FTC (866 (63.5%) categorized to TD1, 498 (36.5%) to TD2) alerts occurred in 356 patients. In 46.2% of FTC same day telephone contact was performed in group TD1 compared to 18.3% in group TD2 (p<0.001). Accordingly, the median time to contact was significantly longer in TD2 compared to TD1 (2 (1–3) vs. 0 (0–1); p<0.001). Rates of no telephone contact were not different between the groups (12.1% vs. 12.4%; p=0.866). Although, signs of worsening HF were prevalent in 32.4% in TD1 vs. 32.1% in TD2 (p=0.996), initiation of a pharmacological intervention was more likely in TD1 compared to TD2 (27.9% vs. 22.9%; p=0.041). No differences existed concerning hospitalization for HF within 30 days after FTC (3.9% vs. 3.4%; p=0.636). Conclusion Transmission of FTC alerts during weekends and on bank holidays were less likely associated with timely patient contacts and initiation of pharmacological intervention than during the week. Telemedical centers providing 24/7 remote monitoring service might help to optimize patient care. Funding Acknowledgement Type of funding source: None

Differences in management of telemedicine alerts on weekdays and public holidays: Results from the OptiLink heart failure trial

2021 ◽  
pp. 1357633X2110393
Author(s):  
Jan Wintrich ◽  
Valerie Pavlicek ◽  
Johannes Brachmann ◽  
Ralph Bosch ◽  
Christian Butter ◽  
...  
Keyword(s):  
Heart Failure ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Pharmacological Intervention ◽  
Ventricular Ejection Fraction ◽  
Telephone Contact ◽  
Threshold Crossing ◽  
Monitoring Service ◽  
Public Holidays ◽  
Specific Education

Background In the OptiLink heart failure study, timely and appropriate reactions to telemedicine alerts improved clinical outcomes in heart failure patients. This analysis investigates the relation between the weekday of alert transmission and the subsequent patient contact. Methods In patients enrolled in the intervention arm of the OptiLink heart failure study ( n = 505, age 66.1 ± 10.1, 77.2% male, left-ventricular ejection fraction 26.7% ± 6.1%), fluid index threshold crossing alerts were analysed according to the weekday of the transmission. Transmissions on Mondays–Thursdays were categorized as TD1, Fridays–Sundays as well as public holidays as TD2. Results Of 1365 transmitted alerts, 867 (63.5%) were categorized as TD1 and 498 (36.5%) as TD2. Same day telephone contacts were more frequent in TD1 (46.2%) than in TD2 (18.3%; p < 0.001). Accordingly, the median time to contact was significantly longer in TD2 compared with TD1 (2(1–3) vs 0(0–1) days; p < 0.001). Rates of no telephone contact were no different between the groups (12.1% vs 12.4%; p = 0.866). Although signs of worsening heart failure were prevalent in 32.4% in TD1 versus 32.1% in TD2 ( p = 0.996), initiation of a pharmacological intervention occurred more likely in TD1 compared with TD2 (27.9% vs 22.9%; p = 0.041). No differences existed concerning hospitalization for heart failure within 30 days after alert transmission (3.9% vs 3.4%; p = 0.636). Conclusion Alert transmissions during weekends and public holidays were less likely associated with timely patient contacts and initiation of pharmacological interventions than during the week. Telemedical centres providing 24/7 remote monitoring service and specific education programmes for physicians might help to optimize patient care.

scholarly journals Clinic time required to manage cardiac implantable electronic device patients: a time and motion workflow evaluation

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
E Biundo ◽  
A Burke ◽  
S Rosemas ◽  
D Lanctin ◽  
E Nicolle
Keyword(s):  
Remote Monitoring ◽  
Electronic Device ◽  
Future Research ◽  
Funding Source ◽  
Staff Time ◽  
Private Company ◽  
Remote Transmission ◽  
Time And Motion ◽  
Time Required

Abstract Background The population with cardiac implantable electronic devices (CIEDs) is growing, creating workload for device clinics to manage these patients. However, the CIED follow-up workflow is poorly understood. This study sought to characterize the workflow and staff time for CIED patient management. Methods A time and motion workflow evaluation was performed in 6 U.S. CIED clinics, which manage an average of 4,217 patients. Each task involved in CIED management was repeatedly timed, including all manufacturers, during 1 business week at each clinic. Mean staff time for a remote transmission and an in-person visit were calculated, including all clinical and administrative (e.g: scheduling, documentation) activities related to the encounter. Annual staff time for follow-up of 1 patient was modeled using CIED transmission data for the 6 clinics, guidelines for CIED follow-up, and published literature. Results 124 clinic visits and 1,374 remote monitoring activities were observed. Staff time required per remote transmission ranged from 12.1–13.4 minutes (depending on the CIED type), and time per visit was 43.4–51.0 minutes. Including all remote and in-person follow-ups, the estimated total staff time per year to manage one pacemaker, ICD, CRT, and ICM patient was 2.3, 2.4, 2.4, and 9.3 hours, respectively (Table 1). Conclusion CIED clinic workflow is complex and requires significant staff time. Remote monitoring is an efficient complement to in-office visits, allowing for continuous follow-up of patients. Future research should examine heterogeneity in clinic processes to identify the most efficient workflow. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Medtronic

scholarly journals Remote Monitoring with Appropriate Reaction to Alerts Was Associated with Improved Outcomes in Chronic Heart Failure: Results from the OptiLink HF Study

2020 ◽  
Author(s):  
Jan Wintrich ◽  
Valérie Pavlicek ◽  
Johannes Brachmann ◽  
Ralph Bosch ◽  
Christian Butter ◽  
...  
Keyword(s):  
Heart Failure ◽  
Remote Monitoring ◽  
Cardiovascular Death ◽  
Medical Intervention ◽  
Implantable Cardioverter Defibrillators ◽  
Cardiac Decompensation ◽  
Clinical Events ◽  
Improved Outcomes ◽  
Cardioverter Defibrillators

Background - Impedance-based remote monitoring (RM) failed to reduce clinical events in the OptiLink HF trial. However, rates of alert-driven interventions triggered by intrathoracic fluid index threshold crossings (FTC) were low indicating physicians' inappropriate reactions to alerts. Methods - We separated appropriate from inappropriate contacts to FTC transmissions in the OptiLink HF trial. Appropriate contacts had to meet the following criteria: i) initial telephone contact within 2 working days after FTC transmission, ii) follow-up contacts according to study protocol, and iii) medical intervention initiated after FTC due to cardiac decompensation. We compared time to cardiovascular death or heart failure hospitalization between RM patients contacted appropriately or inappropriately and patients with usual care (UC). Results - In the RM group, at least one FTC alert was transmitted in 356 patients (70.5%; n=505). Of note, only 55.5% (n=758) of all transmitted FTCs (n=1365) were followed by an appropriate contact. While 113 patients (31.7%; n=356) have been contacted appropriately after every FTC, in 243 patients (68.3%; n=356) at least one FTC was not responded by an appropriate contact. Compared to UC, RM with appropriate contacts to FTC alerts independently reduced the risk of the primary endpoint (Hazard ratio, 0.61; 95% confidence interval 0.39-0.95; p=0.027). Conclusions - RM appropriate reactions to FTC alerts are associated with significantly improved clinical outcomes in patients with advanced HF and implantable cardioverter-defibrillators.

Adequate contacts after remote monitoring alerts were associated with improved outcomes in chronic heart failure: results from the OptiLink HF study

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
J Wintrich ◽  
V.P Pavlicek ◽  
J.B Brachmann ◽  
R.B Bosch ◽  
C.B Butter ◽  
...  
Keyword(s):  
Heart Failure ◽  
Clinical Outcomes ◽  
Fluid Overload ◽  
Medical Intervention ◽  
Lower Number ◽  
Telephone Contact ◽  
Cardioverter Defibrillator ◽  
Fluid Status ◽  
Improved Outcomes

Abstract Aims To investigate the effects of adequate reactions to telemedicine alerts triggered by fluid index threshold crossings (FTC) on clinical outcomes in the OptiLink HF trial. Methods We separated adequate from inadequate reactions to FTC transmissions in patients with remote impedance-based monitoring (RM) of fluid status in the OptiLink HF trial. Adequate contacts had to meet the following criteria: i) initial telephone contact within 2 working days after FTC transmission, ii) follow-up contacts according to study protocol, and iii) medical intervention initiated after FTC due to true fluid overload. We compared time to cardiovascular (CV) death or heart failure (HF) hospitalization and all CV- and HF-hospitalizations at follow-up between RM patients contacted adequately or inadequately and patients with usual care (UC). Results In the RM group, transmission of at least one FTC alert occurred in 356 patients (70.5%; n=505). While 113 patients (31.7%; n=356) have been contacted adequately after every FTC, in 243 patients (68.3%; n=356) at least one FTC was not responded by an adequate contact. Adequate responses to RM significantly reduced risk of the primary endpoint (hazard ratio (HR), 0.68; 95% confidence interval (CI) 0.48–0.95; p=0.025, figure 1), and led to a significantly lower number of CV (52.1±7.5 vs. 99.9±19.8; p=0.007) and HF hospitalizations per 100 patient years when compared with UC (26.1±4.4 vs. 67±15.2; p=0.007). Conclusion RM with adequate reactions to FTC alerts significantly reduced total number of both CV and HF hospitalizations and improved clinical outcomes in patients with advanced HF and implantable cardioverter defibrillator (ICD). Funding Acknowledgement Type of funding source: None

Automatic Remote Monitoring of Implantable Cardiac Devices in Clinical Practice – The Lumos-T Safely Reduces Routine Office Device Follow-up (TRUST) Trial

2010 ◽  
Vol 6 (3) ◽  
pp. 87
Author(s):  
Niraj Varma ◽  
Keyword(s):  
Clinical Practice ◽  
Remote Monitoring ◽  
Home Monitoring ◽  
Implantable Devices ◽  
Cardiac Device ◽  
Cardiac Devices ◽  
Enhance Patient Safety ◽  
Implantable Cardiac Devices ◽  
Post Implantation

The use of implantable electronic cardiac devices is increasing. Post-implantation follow-up is important for monitoring both device function and patient condition; however, clinical practice is inconsistent. For example, implantable cardioverter–defibrillator follow-up schedules vary from every three months to yearly according to facility and physician preference and the availability of resources. Importantly, no surveillance occurs between follow-up visits. By contrast, implantable devices with automatic remote monitoring capability provide a means for performing constant surveillance, with the ability to identify salient problems rapidly. The Lumos-T Reduces Routine Office Device Follow-up Study (TRUST) demonstrated that remote home monitoring reduced clinic burden and allowed early detection of patient and/or system problems, enabling efficient monitoring and an opportunity to enhance patient safety. The results of the trial have significant implications for the management of patients receiving all forms of implantable electronic cardiac device.

Creation of physiologic rhythm by closed loop stimulation in heart failure patients with severe chronotropic incompetence: worldwide first results of a pilot study

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
J Proff ◽  
B Merkely ◽  
R Papp ◽  
C Lenz ◽  
P.J Nordbeck ◽  
...  
Keyword(s):  
Heart Rate ◽  
Closed Loop ◽  
Funding Source ◽  
Chronotropic Incompetence ◽  
First Results ◽  
The Mean ◽  
Group 2 ◽  
Group 1

Abstract Background The prevalence of chronotropic incompetence (CI) in heart failure (HF) population is high and negatively impacts prognosis. In HF patients with an implanted cardiac resynchronisation therapy (CRT) device and severe CI, the effect of rate adaptive pacing on patient outcomes is unclear. Closed loop stimulation (CLS) based on cardiac impedance measurement may be an optimal method of heart rate adaptation according to metabolic need in HF patients with severe CI. Purpose This is the first study evaluating the effect of CLS on the established prognostic parameters assessed by the cardio-pulmonary exercise (CPX) testing and on quality of life (QoL) of the patients. Methods A randomised, controlled, double-blind and crossover pilot study has been performed in CRT patients with severe CI defined as the inability to achieve 70% of the age-predicted maximum heart rate (APMHR). After baseline assessment, patients were randomised to either DDD-CLS pacing (group 1) or DDD pacing at 40 bpm (group 2) for a 1-month period, followed by crossover for another month. At baseline and at 1- and 2-month follow-ups, a CPX was performed and QoL was assessed using the EQ-5D-5L questionnaire. The main endpoints were the effect of CLS on ventilatory efficiency (VE) slope (evaluated by an independent CPX expert), the responder rate defined as an improvement (decrease) of the VE slope by at least 5%, percentage of maximal predicted heart rate reserve (HRR) achieved, and QoL. Results Of the 36 patients enrolled in the study, 20 fulfilled the criterion for severe CI and entered the study follow-up (mean age 68.9±7.4 years, 70% men, LVEF=41.8±9.3%, 40%/60% NYHA class II/III). Full baseline and follow-up datasets were obtained in 17 patients. The mean VE slope and HRR at baseline were 34.4±4.4 and 49.6±23.8%, respectively, in group 1 (n=7) and 34.5±12.2 and 54.2±16.1% in group 2 (n=10). After completing the 2-month CPX, the mean difference between DDD-CLS and DDD-40 modes was −2.4±8.3 (group 1) and −1.2±3.5 (group 2) for VE slope, and 17.1±15.5% (group 1) and 8.7±18.8% (group 2) for HRR. Altogether, VE slope improved by −1.8±2.95 (p=0.31) in DDD-CLS versus DDD-40, and HRR improved by 12.9±8.8% (p=0.01). The VE slope decreased by ≥5% in 47% of patients (“responders to CLS”). The mean difference in the QoL between DDD-CLS and DDD-40 was 0.16±0.25 in group 1 and −0.01±0.05 in group 2, resulting in an overall increase by 0.08±0.08 in the DDD-CLS mode (p=0.13). Conclusion First results of the evaluation of the effectiveness of CLS in CRT patients with severe CI revealed that CLS generated an overall positive effect on well-established surrogate parameters for prognosis. About one half of the patients showed CLS response in terms of improved VE slope. In addition, CLS improved quality of life. Further clinical research is needed to identify predictors that can increase the responder rate and to confirm improvement in clinical outcomes. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Biotronik SE & Co. KG

Coronary sinus catalase and ceruloplasmin levels predict all-cause mortality in patients with end-stage heart failure awaiting heart transplantation

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
W Szczurek ◽  
M Gasior ◽  
M Skrzypek ◽  
G Kubiak ◽  
A Kuczaj ◽  
...  
Keyword(s):  
Heart Failure ◽  
Heart Transplantation ◽  
Coronary Sinus ◽  
Public Institution ◽  
Funding Source ◽  
Organ Shortage ◽  
Number Of Patients ◽  
End Stage ◽  
Medical University

Abstract   Background, As a consequence of the worldwide increase in life expectancy and due to significant progress in the pharmacological and interventional treatment of heart failure (HF), the proportion of patients that reach an advanced phase of disease is steadily growing. Hence, more and more numerous group of patients is qualified to the heart transplantation (HT), whereas the number of potential heart donors has remained invariable since years. It contributes to deepening in disproportion between the demand for organs which can possibly be transplanted and number of patients awaiting on the HT list. Therefore, accurate identification of patients who are most likely to benefit from HT is imperative due to an organ shortage and perioperative complications. Purpose The aim of this study was to identify the factors associated with reduced survival during a 1.5-year follow-up in patients with end-stage HF awating HT. Method We propectively analysed 85 adult patients with end-stage HF, who were accepted for HT at our institution between 2015 and 2016. During right heart catheterization, 10 ml of coronary sinus blood was additionally collected to determine the panel of oxidative stress markers. Oxidative-antioxidant balance markers included glutathione reductase (GR), glutathione peroxidase (GPx), glutathione transferase (GST), superoxide dismutase (SOD) and its mitochondrial isoenzyme (MnSOD) and cytoplasmic (Cu/ZnSOD), catalase (CAT), malondialdehyde (MDA), hydroperoxides lipid (LPH), lipofuscin (LPS), sulfhydryl groups (SH-), ceruloplasmin (CR). The study protocol was approved by the ethics committee of the Medical University of Silesia in Katowice. The endpoint of the study was mortality from any cause during a 1.5 years follow-up. Results The median age of the patients was 53.0 (43.0–56.0) years and 90.6% of them were male. All included patients were treated optimally in accordance with the guidelines of the European Society of Cardiology. Mortality rate during the follow-up period was 40%. Multivariate logistic regression analysis showed that ceruloplasmin (odds ratio [OR] = 0.745 [0.565–0.981], p=0.0363), catalase (OR = 0.950 [0.915–0.98], p=0.0076), as well as high creatinine levels (OR = 1.071 [1.002–1.144], p=0.0422) were risk factors for death during 1.5 year follow-up. Conclusions Coronary sinus lower ceruloplasmin and catalase levels, as well as higher creatinine level are independently associated with death during 1.5 year follow-up. Funding Acknowledgement Type of funding source: Public Institution(s). Main funding source(s): Medical University of SIlesia, Katowice, POland

External validation of a heart failure risk prediction model in a remote monitoring cohort submitted to cardiac resynchronization therapy

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
I Cardoso ◽  
M Coutinho ◽  
G Portugal ◽  
A Valentim ◽  
A.S Delgado ◽  
...  
Keyword(s):  
Heart Failure ◽  
Heart Rate ◽  
High Risk ◽  
Remote Monitoring ◽  
Hospital Admissions ◽  
External Validation ◽  
Left Ventricular Ejection ◽  
National Database ◽  
Failure Risk

Abstract Background Patients (P) submitted to cardiac ressynchronization therapy (CRT) are at high risk of heart failure (HF) events during follow-up. Continuous analysis of various physiological parameters, as reported by remote monitoring (RM), can contribute to point out incident HF admissions. Tailored evaluation, including multi-parameter modelling, may further increase the accuracy of such algorithms. Purpose Independent external validation of a commercially available algorithm (“Heart Failure Risk Status” HFRS, Medtronic, MN USA) in a cohort submitted to CRT implantation in a tertiary center. Methods Consecutive P submitted to CRT implantation between January 2013 and September 2019 who had regular RM transmissions were included. The HFRS algorithm includes OptiVol (Medtronic Plc., MN, USA), patient activity, night heart rate (NHR), heart rate variability (HRV), percentage of CRT pacing, atrial tachycardia/atrial fibrillation (AT/AF) burden, ventricular rate during AT/AF (VRAF), and detected arrhythmia episodes/therapy delivered. P were classified as low, medium or high risk. Hospital admissions were systematically assessed by use of a national database (“Plataforma de Dados de Saúde”). Accuracy of the HFRS algorithm was evaluated by random effects logistic regression for the outcome of unplanned hospital admission for HF in the 30 days following each transmission episode. Results 1108 transmissions of 35 CRT P, corresponding to 94 patient-years were assessed. Mean follow-up was 2.7 yrs. At implant, age was 67.6±9.8 yrs, left ventricular ejection fraction 28±7.8%, BNP 156.6±292.8 and NYHA class &gt;II in 46% of the P. Hospital admissions for HF were observed within 30 days in 9 transmissions. Stepwise increase in HFRS was significantly associated with higher risk of HF admission (odds ratio 12.7, CI 3.2–51.5). HFRS had good discrimination for HF events with receiving-operator curve AUC 0.812. Conclusions HFRS was significantly associated with incident HF admissions in a high-risk cohort. Prospective use of this algorithm may help guide HF therapy in CRT recipients. Funding Acknowledgement Type of funding source: None

Long-term systolic blood pressure and all-cause mortality in heart failure with preserved ejection fraction: an analysis of the TOPCAT trial

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
P Huang ◽  
C Liu
Keyword(s):  
Heart Failure ◽  
Blood Pressure ◽  
Ejection Fraction ◽  
Funding Source ◽  
Preserved Ejection Fraction ◽  
Risk Of Mortality ◽  
All Cause Mortality ◽  
History Of

Abstract Background Lower systolic blood pressure (SBP) at admission or discharge was associated with poor outcomes in patients with heart failure and preserved ejection fraction (HFpEF). However, the optimal long-term SBP for HFpEF was less clear. Purpose To examine the association of long-term SBP and all-cause mortality among patients with HFpEF. Methods We analyzed participants from the Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist (TOPCAT) study. Participants had at least two SBP measurements of different times during the follow-up were included. Long-term SBP was defined as the average of all SBP measurements during the follow-up. We stratified participants into four groups according to long-term SBP: &lt;120mmHg, ≥120mmHg and &lt;130mmHg, ≥130mmHg and &lt;140mmHg, ≥140mmHg. Multivariable adjusted Cox proportional hazards models were used to estimate hazard ratios (HRs) and 95% confidence intervals (CI) for all-cause mortality associated with SBP level. To assess for nonlinearity, we fitted restricted cubic spline models of long-term SBP. Sensitivity analyses were conducted by confining participants with history of hypertension or those with left ventricular ejection fraction≥50%. Results The 3338 participants had a mean (SD) age of 68.5 (9.6) years; 51.4% were women, and 89.3% were White. The median long-term SBP was 127.3 mmHg (IQR 121–134.2, range 77–180.7). Patients in the SBP of &lt;120mmHg group were older age, less often female, less often current smoker, had higher estimated glomerular filtration rate, less often had history of hypertension, and more often had chronic obstructive pulmonary disease and atrial fibrillation. After multivariable adjustment, long-term SBP of 120–130mmHg and 130–140mmHg was associated with a lower risk of mortality during a mean follow-up of 3.3 years (HR 0.65, 95% CI: 0.49–0.85, P=0.001; HR 0.66, 95% CI 0.50–0.88, P=0.004, respectively); long-term SBP of &lt;120mmHg had similar risk of mortality (HR 1.03, 95% CI: 0.78–1.36, P=0.836), compared with long-term SBP of ≥140mmHg. Findings from restricted cubic spline analysis demonstrate that there was J-shaped association between long-term SBP and all-cause mortality (P=0.02). These association was essentially unchanged in sensitivity analysis. Conclusions Among patients with HFpEF, long-term SBP showed a J-shaped pattern with all-cause mortality and a range of 120–140 mmHg was significantly associated with better outcomes. Future randomized controlled trials need to evaluate optimal long-term SBP goal in patients with HFpEF. Funding Acknowledgement Type of funding source: Foundation. Main funding source(s): China Postdoctoral Science Foundation Grant (2019M660229 and 2019TQ0380)

scholarly journals Silent cerebral embolisation during TAVI: evolution, predictors and neurocognitive effects

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
M De Carlo ◽  
R Liga ◽  
G.M Migaleddu ◽  
M Scatturin ◽  
C Spaccarotella ◽  
...  
Keyword(s):  
White Matter ◽  
Median Number ◽  
Funding Source ◽  
Private Company ◽  
Diffuse White Matter ◽  
Transcatheter Aortic Valve ◽  
Age Related ◽  
Cerebral Mri ◽  
Neurocognitive Evaluation

Abstract Background Most patients undergoing transcatheter aortic valve implantation (TAVI) develop silent cerebral ischemic lesions (SCIL) detectable at magnetic resonance imaging (MRI). The natural history and clinical relevance of SCIL are not well established. We aimed to assess the characteristics, predictors, evolution, and neurocognitive effects of SCIL. Methods Cerebral MRI was performed within 7 days before TAVI to assess baseline status and age-related white matter changes (ARWMC) score. MRI was repeated postoperatively to assess the occurrence, location, number and dimensions of SCIL. Patients developing SCIL underwent a third MRI at 3–5 months follow-up. A neurocognitive evaluation was performed before TAVI, at discharge and at 3-month follow-up. Results Of the 117 patients enrolled, 96 underwent a postprocedural MRI; SCIL were observed in 76% of patients, distributed in all vascular territories, with a median number of 2 lesions, median diameter 4.5 mm, and median total volume 140 mm3. Independent predictors of SCIL occurrence were a higher baseline ARWMC score and the use of self-expanding or mechanically-expanded bioprostheses. Among 47 patients who underwent follow-up MRI, only 26.7% of postprocedural SCIL evolved into a gliotic scar. SCIL occurrence was associated with a more pronounced transient neurocognitive decline early after TAVI and with a lower recovery at follow-up. Conclusions SCIL occur in the vast majority of patients undergoing TAVR and are predicted by a more diffuse white matter damage at baseline and by the use of non-balloon-expandable prostheses. Although most SCIL disappear within months, their occurrence has a limited but significant impact on neurocognitive function. Figure 1 Funding Acknowledgement Type of funding source: Private company. Main funding source(s): unrestricted grants from Edwards Lifesciences SA, Nyon, Switzerland, and from Medtronic Italia SpA, Milan, Italy

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