Remote Cardiovascular Monitoring in Post-TAVI Patients

Official title

Remote Acute Monitoring-based Same-day Discharge Strategy of Post Transcatheter Aortic Valve Implantation Patients Versus Standard Care at 30-Day Follow-up

Overview

The goal of this randomised clinical trial is to utilise a remote monitoring algorithm to gather essential clinical data, aiming to guide the management of post-Transcatheter Aortic Valve Implantation (TAVI) patients and reduce both postprocedural hospital length of stay and readmissions. This strategic integration of technology aims to address gaps identified in previous studies and enhance the effectiveness of post-TAVI patient care. One significant concern after TAVI is the development of heart conduction abnormalities on the ECG and abnormal rhythms, such as heart block, potentially requiring permanent pacemaker insertion. Addressing these rhythm issues is crucial for reducing the overall length of stay. The main question it aims to answer is: Does a remote patient monitoring protocol-driven strategy reduce post-TAVI hospital length of stay and adverse events? Participants post-TAVI procedure and eligible for same-day discharge, as determined by their primary cardiologist, will be randomized upon informed consent into the active arm (remote monitoring) or control group (standard of care). Participants in the active arm will: receive four remote monitoring devices. Receive support from a validated clinical decision-making algorithm for further management. Participants in the control group will: adhere to the best standard of care as per current practice. Researchers will compare the active arm to the control group to see if the remote patient monitoring protocol-driven strategy reduces post-TAVI hospital length of stay and adverse events.

Detailed description

Given the susceptibility of post-TAVI patients to bradyarrhythmias and extended hospitalisation is not economically plausible, a shift toward remote monitoring could be both justifiable and has the potential to enhance outcomes and able to predict deterioration following TAVI. Despite the well-characterized high safety and effectiveness profile of TAVI across various surgical risk groups, the adoption of same-day discharge remains limited. Addressing post-TAVI arrhythmias is crucial to minimising the total postprocedural length of stay. Therefore, by embracing a minimalist approach and leveraging the vastly grown operators experience, the current post-TAVI care could be further enhanced with the integration of remote monitoring. This strategic shift aligns with the objective of optimising care by the ability to predict deterioration that can be treated to avoid in-hospital care.

Technology-enabled patient care and monitoring has been steadily improving, and AI-enabled remote patient monitoring devices has brought a crucial advantage to an outside-of-hospital cardiac investigation. The potential to remotely detect any adverse effects that patients might develop after the procedure is promising. There is an increased uptake of ECG telemetry, which might serve as a valuable tool that may significantly reduce hospital LOS at 30 days and possibly could reduce 3 months' adverse outcomes. This approach may enhance patient care and optimise post-TAVI outcomes through an efficient patient-tailored approach. Several studies have utilised remote or ambulatory ECG for post-TAVI on different clinical outcomes - however, to date, no RCT has been conducted using this approach. The findings of remote ECG monitoring studies are inconsistent with various monitoring periods and patient selection criteria. Although such studies utilised ECG monitoring, they did not integrate a strategy or pathway for out-of-hospital monitoring and clinical decision algorithms during home monitoring. To date, the TELE-TAVI trial will be the first monitoring study to incorporate live event detection and alert notification system supported by the bespoke Smartcardia 7-lead continuous ECG patch monitor in an RCT.

In order to better understand the impact of remote patient monitoring after TAVI, this trial proposes the utilisation of a remote monitoring algorithm to provide essential clinical data for guiding management, with the primary aim of reducing postprocedural hospital length of stay and readmissions. This strategic technology integration aims to address the gaps identified in previous studies and enhance the effectiveness of post-TAVI patient care.

Thus, it has been hypothesised that:

1. A remote patient monitoring protocol-driven strategy for same-day discharge, post-TAVI, is superior to the current standard of care follow-up in reducing cumulative 30-day hospital length of stay (LOS). 2. The novel remote patient monitoring strategy, supported by a clinical decisions algorithm, is more effective at prioritising patient presentations and optimising outcomes through early identification of adverse events, such as the need for a pacemaker, when compared to the standard of care.

The principal aims of this clinical randomised trial are:

* To facilitate a safe same-day discharge after TAVI through a remote monitoring approach in order to reduce postprocedural hospitalisation. * To integrate an algorithm-based clinical decision-making protocol that enhances remote monitoring and the detection of post-TAVI adverse events, particularly focusing on cardiac conduction complications. * To test the effectiveness of the remote monitoring strategy in the cost-effectiveness of post-TAVI patients' hospital admission and re-admission.

Interventions

• Other Remote Patient Monitoring Strategy
  Continuous remote monitoring with the SmartCardia device includes continuous heart rate and cardiac conduction rhythm tracking through a 7-lead ECG enhanced by machine learning. This system can detect cardiac rhythm disturbances, measure breathing and heart rate, and provide live-alert notifications. Daily 12-lead ECG will be collected from each patient for 7 days after discharge; patients are instructed to perform a daily 12-lead ECG on the SHL device, along with recording blood pressure and ox
• Other Standard Medical Therapy
  No intervention is required. Patients in this arm will fill out a self-reported anxiety report (SHAI form) and provide recent admission information

Primary outcome measures

• Cumulative length of stay within 30 days of the procedure. [Time frame: 30 days]

Secondary outcome measures (6)

• The difference in rate of new PPM implantation at 3 months. [Time frame: 3 months]
• Rate of emergency room visits not requiring admission [Time frame: 3 months]
• Number of all hospital admissions at 3 months [Time frame: 3 months]
• Mortality Rate at 30 days [Time frame: 30 days]
• Patient score for the patient-reported anxiety improvement analysis [Time frame: at discharge and 30 days]
• Number of instances of major adverse cardiovascular events [Time frame: 3 months]

Eligibility criteria

Inclusion criteria

• Patient age must be 18 years or above.
• Post-TAVI patients without serious complications hindering same-day discharge, including vascular, neurological, and cardiac postprocedural complications necessitating inpatient care:
• Vascular: Controlled with adequate vascular hemostasis.
• Neurological: Conscious and oriented, not under the effect of residual sedation.
• Cardiac: No significant pericardial effusion.
• Elective non-emergent patient admission and nonelective cases fitting discharge criteria.
• Comfortable ambulation post-procedure.
• The patient or their caregiver must have access to a smart device.
• Ability to provide informed consent (the patient must be alert and oriented for consent).
• Adequate social support.

Exclusion criteria

• Hemodynamically unstable post-TAVI condition, periprocedural cardiac arrest, cerebral vascular accident, acute kidney injury (AKI) and major/life-threatening bleeding requiring blood transfusion.
• Patients with a permanent (pre-existing or new) implanted pacing device.
• Procedural failure in device delivery.
• Major vascular access complications require patients to stay.
• Inability to engage with the technology.
• Significant communication barrier.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United Kingdom · 1 center

• Hammersmith Hospital — London

Publications

• Otto CM, Nishimura RA, Bonow RO, Carabello BA, Erwin JP 3rd, Gentile F, Jneid H, Krieger EV, Mack M, McLeod C, O'Gara PT, Rigolin VH, Sundt TM 3rd, Thompson A, Toly C. 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2021 Feb 2;14 PMID 33332150
• Massoullie G, Bordachar P, Irles D, Caussin C, Da Costa A, Defaye P, Jean F, Mechulan A, Mondoly P, Souteyrand G, Pereira B, Ploux S, Eschalier R. Prognosis assessment of persistent left bundle branch block after TAVI by an electrophysiological and remote monitoring risk-adapted algorithm: rationale and design of the multicentre LBBB-TAVI Study. BMJ Open. 2016 Oct 26;6(10):e010485. doi: 10.1136/bm PMID 27797979
• Natarajan MK, Sheth TN, Wijeysundera HC, Chavarria J, Rodes-Cabau J, Velianou JL, Radhakrishnan S, Newman T, Smith A, Wong JA, Schwalm JD, Duong M, Mian RI, Bishop MG, Healey JS. Remote ECG monitoring to reduce complications following transcatheter aortic valve implantations: the Redirect TAVI study. Europace. 2022 Oct 13;24(9):1475-1483. doi: 10.1093/europace/euac042. PMID 35699482
• Xu S, Zhang E, Qian Z, Sun J, Zou F, Wang Y, Hou X, Zou J. Mid- to Long-Term Clinical and Echocardiographic Effects of Post-procedural Permanent Pacemaker Implantation After Transcatheter Aortic Valve Replacement: A Systematic Review and Meta-Analysis. Front Cardiovasc Med. 2022 Jun 28;9:911234. doi: 10.3389/fcvm.2022.911234. eCollection 2022. PMID 35837611
• Glikson M, Nielsen JC, Kronborg MB, Michowitz Y, Auricchio A, Barbash IM, Barrabes JA, Boriani G, Braunschweig F, Brignole M, Burri H, Coats AJS, Deharo JC, Delgado V, Diller GP, Israel CW, Keren A, Knops RE, Kotecha D, Leclercq C, Merkely B, Starck C, Thylen I, Tolosana JM; ESC Scientific Document Group. 2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy. Eur Heart J. 202 PMID 34455430
• Prihadi EA, Leung M, Vollema EM, Ng ACT, Ajmone Marsan N, Bax JJ, Delgado V. Prevalence and Prognostic Relevance of Ventricular Conduction Disturbances in Patients With Aortic Stenosis. Am J Cardiol. 2017 Dec 15;120(12):2226-2232. doi: 10.1016/j.amjcard.2017.08.046. Epub 2017 Sep 18. PMID 29037444
• Muntane-Carol G, Urena M, Nombela-Franco L, Amat-Santos I, Kleiman N, Munoz-Garcia A, Atienza F, Serra V, Deyell MW, Veiga-Fernandez G, Masson JB, Canadas-Godoy V, Himbert D, Castrodeza J, Elizaga J, Francisco Pascual J, Webb JG, de la Torre Hernandez JM, Asmarats L, Pelletier-Beaumont E, Philippon F, Rodes-Cabau J. Arrhythmic burden in patients with new-onset persistent left bundle branch block a PMID 33083813
• Hartrampf B, Jochheim D, Steffen J, Czermak T, Sadoni S, Lemmermohle E, Klier I, Estner HL, Massberg S, Mehilli J, Lackermair K, Fichtner S. Permanent pacemaker dependency in patients with new left bundle branch block and new first degree atrioventricular block after transcatheter aortic valve implantation. Sci Rep. 2021 Dec 21;11(1):24383. doi: 10.1038/s41598-021-03667-0. PMID 34934073

Identifiers

NCT: NCT06602609 · 24HH8773

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗