Jan Baan

Guideline-defined futility or patient-reported outcomes to assess treatment success after TAVI: what to use? Results from a prospective cohort study with long-term follow-up

Objective Transcatheter aortic valve implantation (TAVI) provides a significant symptom relief and mortality reduction in most patients; however, a substantial group of patients does not experience the same beneficial results according to physician-determined outcomes. Methods Single-centre prospective design; the population comprises all consecutive patients undergoing TAVI in 2012–2017. TAVI futility was defined as the combined endpoint of either no symptomatic improvement or mortality at 1 year. We actively gathered telephone follow-up using a predefined questionnaire. Results Guideline defined TAVI futility was present in 212/741 patients. Multivariate regression showed lower albumin and non-transfemoral approach to be predictive for futility. In addition to these, chronic obstructive pulmonary disease, lower estimated glomerular filtration rate, atrial fibrillation, low-flow–low-gradient aortic stenosis and lower Body Mass Index were predictive for 1-year mortality. Patients who showed symptomatic benefit estimated the percentage in which their symptoms were remedied higher than patients who did not (80% vs 60%, p<0.001). Guideline-defined TAVI futility occurs frequently, contrasting with patient-reported outcome measures (PROMs). The vast majority in both groups would again choose for TAVI treatment. Conclusion Lower albumin and non-transfemoral access route were predictors for guideline-defined TAVI futility, defined as mortality within 1 year or no objective symptomatic improvement in New York Heart Association class. Futility according to this definition occurred frequently in this study, contrasting with much more positive PROMs. The majority of patients would undergo a TAVI again, underlining the patients’ experienced value of TAVI and putting the definition of TAVI futility further on debate. In the near future, less-strict criteria for TAVI futility, that is, using a shorter warranted life expectancy and incorporating patients’ perceived outcomes, should be used.

Premedication to reduce anxiety in patients undergoing coronary angiography and percutaneous coronary intervention

Aims In this study, we examined the effects of the routinely administration of benzodiazepines on reducing periprocedural anxiety versus no premedication. Methods In this open label study, we enrolled 1683 patients undergoing diagnostic coronary angiograms (CAG) or percutaneous coronary interventions (PCI). Randomisation was simulated by systematically allocating patients in monthly rotational periods to lorazepam 1  mg/sl, oxazepam 10  mg/po, diazepam 5  mg/po, midazolam 7.5  mg/po or no premedication. Anxiety was measured at four different time points using the one-item Visual Analogue Scale for Anxiety (VAS score) ranging from 0 to 10. The primary outcome was the difference in anxiety reduction (ΔVAS, preprocedure to postprocedure), between the different premedication strategies versus no premedication. Results Anxiety reduction was larger in patients premedicated with lorazepam (ΔVAS=−2.0, SE=1.6, P=0.007) or diazepam (ΔVAS=−2.0, SE=1.5, p=0.003) compared with patients without any premedication (ΔVAS=−1.4, SE=1.2). The use of midazolam or oxazepam did not lead to a significant reduction in anxiety compared with patients who did not receive premedication. Additionally, a high number of patients treated with midazolam (N=39, 19.8%) developed side effects. Conclusions In this study, the use of lorazepam or diazepam was associated with a significant, but modest anxiety reduction in patients undergoing CAG or PCI. This study does not support the standard use of oxazepam or midazolam as premedication to reduce anxiety.

Remote Monitoring of Patients Undergoing Transcatheter Aortic Valve Replacement: A Framework for Postprocedural Telemonitoring

Background The postprocedural trajectory of patients undergoing transcatheter aortic valve replacement (TAVR) involves in-hospital monitoring of potential cardiac rhythm or conduction disorders and other complications. Recent advances in telemonitoring technologies create opportunities to monitor electrocardiogram (ECG) and vital signs remotely, facilitating redesign of follow-up trajectories. Objective This study aimed to outline a potential set-up of telemonitoring after TAVR. Methods A multidisciplinary team systematically framed the envisioned telemonitoring scenario according to the intentions, People, Activities, Context, Technology (iPACT) and Functionality, Interaction, Content, Services (FICS) methods and identified corresponding technical requirements. Results In this scenario, a wearable sensor system is used to continuously transmit ECG and contextual data to a central monitoring unit, allowing remote follow-up of ECG abnormalities and physical deteriorations. Telemonitoring is suggested as an alternative or supplement to current in-hospital monitoring after TAVR, enabling early hospital dismissal in eligible patients and accessible follow-up prolongation. Together, this approach aims to improve rehabilitation, enhance patient comfort, optimize hospital capacity usage, and reduce overall costs. Required technical components include continuous data acquisition, real-time data transfer, privacy-ensured storage, automatic event detection, and user-friendly interfaces. Conclusions The suggested telemonitoring set-up involves a new approach to patient follow-up that could bring durable solutions for the growing scarcities in health care and for improving health care quality. To further explore the potential and feasibility of post-TAVR telemonitoring, we recommend evaluation of the overall impact on patient outcomes and of the safety, social, ethical, legal, organizational, and financial factors.