Predictors of pacemakers after implanting an artificial valve V1.0

  • Research type

    Research Study

  • Full title

    Predictors of requiring a permanent pacemaker implantation following transcatheter aortic valve implantation in the West of Scotland

  • IRAS ID

    338892

  • Contact name

    Daniel Newman

  • Contact email

    daniel.newman@gjnh.scot.nhs.uk

  • Sponsor organisation

    NHS Golden Jubilee University National Hospital

  • Duration of Study in the UK

    0 years, 8 months, 31 days

  • Research summary

    The aortic valve separates the left ventricle and the aorta. Blood flow out of the heart is restricted when this valve is diseased. It can be treated by surgical replacement or by inserting a new valve, called a Transcatheter Aortic Valve Implantation (TAVI), through an artery in the leg up to the heart which then takes over from the diseased valve. TAVI was developed for patients who are unsuitable for surgery. A potential side effect of the TAVI procedure is that the heartrate becomes very slow. It can recover over time but if it doesn’t, a pacemaker can be implanted into the patient to increase the heartrate.

    In this study, we aim to determine the number of patients who received a pacemaker within 30 days after their TAVI procedure and whether there is a pattern linking patients who had a TAVI and a pacemaker. To achieve this, information from previous TAVI procedures performed at the Golden Jubilee Hospital in Scotland between 2018 and 2024 will be collected and analysed. There will be two groups of patients: those who received a pacemaker within 30 days after TAVI and those who did not receive a pacemaker within 30 days after TAVI.

    This work will help us understand whether you can predict how likely it is that a patient will need a pacemaker following their TAVI procedure. If a patient has a high risk of needing a pacemaker after the TAVI procedure, then the appropriate steps can be taken to ensure the clinical team are prepared for that outcome. The risk of needing a pacemaker can be discussed with patients before the TAVI procedure ensuring they are fulling informed before consenting. High-risk patients can also receive close monitoring following the TAVI procedure.

    Lay summary of study results: This study aimed to determine whether there were predictive factors for requiring a permanent pacemaker following a transcatheter aortic valve implantation at the Golden Jubilee University National Hospital.

    Between January 2022 and August 2024, 659 patients received a transcatheter aortic valve implantation for severe aortic stenosis. Forty-seven patients required a permanent pacemaker for a cardiac conduction abnormality. These patients were included for analysis and crossed matched 1:1 by age and sex with patients who did not require a permanent pacemaker.

    The data collected for analysis included: preop test information (electrocardiogram, echocardiogram, computed tomography), procedural information (valve type, balloon aortic valvuloplasty), and post procedure test information (electrocardiogram).

    The overall incidence rate for permanent pacemaker implantations was 7.69%. Following analysis, self-expanding valves were the strongest predictor of a patient requiring a permanent pacemaker following a transcatheter aortic valve implantation. Lower weight and a longer QRS duration were identified as small predictors of requiring a permanent pacemaker following transcatheter aortic valve implantation.

    The results of the present study could be used during transcatheter aortic valve implantation preop assessments to identify patients at a higher risk of requiring a permanent pacemaker post-procedure.

    Future studies should be prospective and incorporate additional factors that have been identified as predictors in past research. The results of the present study could be confirmed and eventually lead to the development of a prediction model that can be used during preop assessments to determine a patient’s risk of requiring a permanent pacemaker following transcatheter aortic valve implantation.

  • REC name

    East Midlands - Nottingham 1 Research Ethics Committee

  • REC reference

    24/EM/0196

  • Date of REC Opinion

    9 Sep 2024

  • REC opinion

    Favourable Opinion