Use of leadless pacemakers increasing; data on effects, implants in India needed, say experts

As the market for leadless pacemakers grows in India doctors point out definite advantages of the technology for heart disease patients but also call for more data and analyses on its longterm effectsAt the same time researchers have written about the lack of a national registry tracking pacemaker implants including conventional onesA pacemaker helps a heart patient control an irregular heartbeatIn November Abbott the USbased healthcare and medical devices company introduced the AVEIR VR singlechamber ventricular leadless pacemaker in India for treating patients having slow heart rhythmsThe device has been approved by the Central Drugs Standard Control Organization Abbott said in a statementThe AVEIR VR device is implanted directly into the hearts right lower chamber ventricle through a minimally invasive catheterbased procedure from the groin thereby requiring no surgical cuts to the chest or wires it saidDoctors consider a leadless pacemaker an advancement over a conventional wired one which has been commonly associated with infectionsA leadless pacemaker offers a powerful option for the treatment of people with cardiac arrhythmias or irregular heartbeats Leadless pacemakers address known complications associated with traditional pacemakers Dr Balbir Singh group chairmanCardiac Sciences Pan Max and chief of Interventional Cardiology andElectrophysiology at Max Hospital Saket said in the statementDr Singh who recently implanted the AVEIR VR device in a 74yearold woman explained that the patient came in a bad shape with a conventional pacing that had got badly infectedShe was running a high fever and was septic There were vegetations infections on the valves of the heart The leads which reach the heart via valves were infected and with them the valves The situation called for urgent intervention he told PTIHe added that the pacemaker causing trouble was removed surgically and the leadless device implanted following which the patient is now going about her daily lifeDr Ajay Kaul chairman of Cardiac Sciences at Fortis Hospital Noida said the technology has definite advantages as the leads or wires in conventional pacemakers increase the chances of infectionMost of the complications with conventional pacemakers were because of the leads they go to the heart via the tricuspid valve where they can cause regurgitation backflow These problems are not present with a leadless pacemaker he told PTIHowever even as patients with a high risk of infection are likely to benefit from leadless pacemakers being a new technology there are concerns especially those related to its longterm effects according to Dr KaulResearch from around the world has documented high success and safety rates suggesting the leadless devices promise in the field of cardiac pacing while also calling for clinical trial data to confirm the perceived advantagesResearchers from the UKs Royal Stoke University Hospital reviewed 18 studies that looked at almost 2500 patients implanted with a leadless pacemaker and found that success rates ranged between 955 and 100 per cent The results were published in 2022 in the Indian Pacing and Electrophysiology JournalAnother trial titled LEADLESS II that enrolled 200 patients from across the US Canada and Europe found that the implant success rate was about 98 per cent with a safety no complications of 96 per centThe most frequent complications were three cases of cardiac tamponade and three premature deployments the authors including those from the Mount Sinai Hospital in the US wrote in the study published in the Journal of the American College of Cardiology JACC Clinical ElectrophysiologyCardiac tamponade can be lifethreatening and occurs when excess fluid or blood fills the pericardium sac surrounding the heart preventing the organ from filling and functioning properlyWhile the technology shows promise in the field of cardiac pacing researchers from Emory Universitys School of Medicine in the US called for more clinical dataAs this technology continues to mature randomised clinical trials comparing this technology to traditional transvenous pacemakers are needed to confirm or refute the perceived advantage of this technology the authors wrote in a 2018 review article published in the Journal of Geriatric CardiologyMeanwhile researchers from India pointed out a lack of national data on pacemaker implants including conventional onesMore than 20000 pacemakers are implanted each year in India and the numbers are growing annually Despite this there is no national registry in India that collects or tracks data of implanted devices the authors from Bengalurus Sri Jayadeva Institute of Cardiovascular Sciences and Research wroteThe 2018 study which examined the profiles of heart patients undergoing pacemaker implants at the tertiary care centre between 1999 and 2014 was published in the Journal of Clinical and Diagnostic ResearchWe need longterm data before we can fully rely on leadless pacemakers Dr Kaul said Although some data is available which has justified the use of this technology more evidence is needed particularly regarding its safetyOther leadless pacemakers available in India are Micra AV developed by Medtronic a medical device company headquartered in the US and Ireland and Abbotts NanostimThis story has been sourced from a third party syndicated feed agencies Midday accepts no responsibility or liability for its dependability trustworthiness reliability and data of the text Midday managementmiddaycom reserves the sole right to alter delete or remove without notice the content in its absolute discretion for any reason whatsoever