Late Breaking Clinical Trials: what do they change in everyday practice in patients who are or will be implanted with cardiac electrotherapy device?

2020 ◽  
Vol 4 (53) ◽  
pp. 4-7
Author(s):  
Ewa Jędrzejczyk-Patej ◽  
Michał Mazurek

Patients with cardiac implantable electronic devices (CIEDs) constitute a considerable population. Issues related to CIEDs both in the field of cardiac pacemakers, cardioverter-defibrillators, and cardiac resynchronization are still intensively studied. This article presents the results of selected, relevant studies on CIEDs announced or published in 2019.

2015 ◽  
Vol 26 (4) ◽  
pp. 356-363
Author(s):  
Melanie T. Gura

Since the introduction of implantable cardiac pacemakers in 1958 and implantable cardioverter-defibrillators in 1980, these devices have been proven to save and prolong lives. Pacemakers, implantable cardioverter-defibrillators, and cardiac resynchronization therapy are deemed life-sustaining therapies. Despite these life-saving technologies, all patients ultimately will reach the end of their lives from either their heart disease or development of a terminal illness. Clinicians may be faced with patient and family requests to withdraw these life-sustaining therapies. The purpose of this article is to educate clinicians about the legal and ethical principles that underlie withdrawal of life-sustaining therapies such as device deactivation and to highlight the importance of proactive communication with patients and families in these situations.


2019 ◽  
Vol 1 (50) ◽  
pp. 14-18
Author(s):  
Karolina Adamczyk ◽  
Ewa Jędrzejczyk-Patej

Cardiac implantable electronic devices (CIEDs) such as pacemakers (PMs), implantable cardioverter-defibrillators (ICDs), both with or without cardiac resynchronization therapy (CRT), became one of the fundamental therapies in present-day electrocardiology. The CIED patients population is increasing year by year due to a growing number of CIED implantations annually and a life prolongation among patients with CIEDs through better pharmacology combined with the proper electrotherapy and patient care. Invasive procedures related to CIED such as an implantation, a replacement or an up-grade of any kind electrotherapy device involves the risk of complications. Pocket hematoma or infection, which are local complications, should be recognized rapidly and treat properly in order to avoid more threatening systemic complications.


2011 ◽  
Vol 3 (1) ◽  
pp. 74
Author(s):  
Kathy L Lee ◽  

Cardiac pacemakers have been the standard therapy for patients with bradyarrhythmias for several decades. The pacing lead is an integral part of the system, serving as a conduit for the delivery of energy pulses to stimulate the myocardium. However, it is also the Achilles’ heel of pacemakers, being the direct cause of most device complications both acutely during implant and chronically years afterwards. Leadless pacing with ultrasound-mediated energy has been demonstrated in animals and humans to be safe and feasible in acute studies. Implantable defibrillators revolutionised the treatment and prevention of sudden cardiac death. Subcutaneous implantable defibrillators have been under development for more than 10 years. A permanent implantable system has been shown to be feasible in treating induced and spontaneous ventricular tachyarrhythmias. These developments and recent advances in pacing and defibrillation will arouse further interest in the research and development of leadless cardiac implantable electronic devices.


EP Europace ◽  
2021 ◽  
Author(s):  
Sharath Kumar ◽  
Jason Davis ◽  
Bernard Thibault ◽  
Iqwal Mangat ◽  
Benoit Coutu ◽  
...  

Abstract Aims Cardiac implantable electronic devices with device advisories have the potential of device malfunction. Remote monitoring (RM) of devices has been suggested to allow the identification of abnormal device performance and permit early intervention. We sought to describe the outcomes of patients with and without RM in devices subject to the Abbott Premature Battery Depletion (PBD) advisory with data from a Canadian registry. Methods and results Patients with an Abbott device subject to the PBD advisory from nine implantable cardioverter defibrillator (ICD) implanting centres in Canada were included in the registry. The use of RM was identified from baseline and follow-up data in the registry. The primary outcome was detection of PBD and all-cause mortality. A total of 2666 patients were identified with a device subject to the advisory. In all, 1687 patients (63.2%) had RM at baseline. There were 487 deaths during follow-up. At a mean follow-up of 5.7 ± 0.7 years, mortality was higher in those without a remote monitor compared with RM at baseline (24.7% vs. 14.5%; P < 0.001). Pre-mature battery depletion was identified in 36 patients (2.1%) with RM vs. 7 (0.7%) without RM (P = 0.004). Time to battery replacement was significantly reduced in patients on RM (median 5 vs. 13 days, P = 0.001). Conclusion The use of RM in patients with ICD and cardiac resynchronization therapy under advisory improved detection of PBD, time to device replacement, and was associated with a reduction in all-cause mortality. The factors influencing the association with mortality are unknown and deserve further study.


2020 ◽  
Vol 4 (FI1) ◽  
pp. 1-6
Author(s):  
Fozia Zahir Ahmed ◽  
Carol Crosbie ◽  
Matthew Kahn ◽  
Manish Motwani

Abstract Background Heart failure (HF) patients with cardiac implantable electronic devices (CIEDs) represent an important cohort. They are at increased risk of hospitalization and mortality. We outline how remote-only management strategies, which leverage transmitted health-related data, can be used to optimize care for HF patients with a CIED during the COVID-19 pandemic. Case summary An 82-year-old man with HF, stable on medical therapy, underwent cardiac resynchronization therapy implantation in 2016. Modern CIEDs facilitate remote monitoring by providing real-time physiological data (thoracic impedance, heart rate and rhythm, etc.). The ‘Triage Heart Failure Risk Score’ (Triage-HFRS), available on Medtronic CIEDs, integrates several monitored physiological parameters into a risk prediction model classifying patients as low, medium, or high risk of HF events within 30 days. In November 2019, the patient was enrolled in an innovative clinical pathway (Triage-HF Plus) whereby any ‘high’ Triage-HF risk status transmission prompts a phone call-based virtual consultation. A high-risk alert was received via remote transmission on 11 March, triggering a phone call assessment. Upon reporting increasing breathlessness, diuretics were initiated. The prescription was remotely issued and delivered to the patient’s home. This approach circumvented the need for all face-to-face reviews, delivering care in an entirely remote manner. Discussion The challenges posed by COVID-19 have prompted us to think differently about how we deliver care for patients, both now and following the pandemic. Contemporary CIEDs facilitate the ability to remotely monitor HF patients by providing rich physiological data that can help identify individuals at elevated risk of decompensation using automated device-generated alerts.


2019 ◽  
Vol 11 (2) ◽  
pp. 81
Author(s):  
Cindy Elfira Boom ◽  
Ornella Widyapuspita

Jumlah pasien pengguna cardiac implantable electronic devices (CIEDs) atau alat elektronik kardiovaskular implan (ALEKA) hingga saat ini makin bertambah setiap tahunnya di penjuru dunia, namun masih banyak ahli anestesi yang belum nyaman dalam mengelola pelayanan perioperatif pada pasien-pasien tersebut dikarenakan kurangnya pengetahuan dan pengalaman pemrograman alat untuk menatalaksana pasien. Alat elektronik kardiovaskular implan merupakan sebuah istilah yang mencakup penggunaan alat pacu jantung untuk bradiaritmia dan implantable cardioverter defibrilator (ICD)/defibrilator kadioverter implan (DKI) untuk takiaritmia, serta cardiac resynchronization therapy (CRT)/ terapi resinkronisasi jantung (TRJ) untuk disfungsi diastolik dengan hambatan konduksi. Hingga saat ini, tercatat setidaknya lebih dari 250.000 pasien dewasa maupun anak menjalani pemasangan alat pacu jantung tiap tahunnya, oleh karena itu, penting bagi seorang dokter anestesi untuk memahami dan mampu membuat perencanaan perioperatif dengan tim multidisiplin agar dapat menurunkan morbiditas dan mortalitas pasien. Tinjauan pustaka ini dibuat untuk memberikan info seputar ALEKA dengan berfokus pada manajemen perioperatif pasien dengan ALEKA, serta algoritma tatalaksana yang dapat diimplementasikan dalam praktik sehari-hari.


2021 ◽  
Vol 2021 ◽  
pp. 1-17
Author(s):  
Francesco Nappi ◽  
Adelaide Iervolino ◽  
Sanjeet Singh Avtaar Singh

Infective endocarditis is a sinister condition with considerable morbidity and mortality. Its relevance in the current era is compounded by the increased use of implanted devices such as replacement valves or cardiac implantable electronic devices. These infections are caused by multiple different bacteria with different virulence, pathogenicity, and antimicrobial resistance. Unlike in native endocarditis, the presence of foreign tissue permits sustenance by inflammatory and thrombotic processes as the artificial surfaces promote inflammatory responses and hypercoagulability. Prevention of these infections has been suggested with the use of homografts in combination with antibiotics. Others have attempted to use “low fouling coats” with little clinical success thus far. The use of antibiotic prophylaxis plays a pivotal part in reducing the incidence of prosthesis-related endocarditis. This remains especially crucial with the increasing use of transcatheter heart valve therapies. The widespread use of cardiac implantable electronic devices such as permanent pacemakers, implantable cardioverter defibrillators, and cardiac resynchronization therapy devices has also heralded a noticeable increase in cases of infectious endocarditis affecting complex equipment which can be difficult to treat. Multimodality strategies are needed with input from surgeons and cardiologists to ensure treatment is both prompt and successful, tailored to the individual needs of the patients.


2015 ◽  
Vol 26 (4) ◽  
pp. 343-355 ◽  
Author(s):  
Robin A. Leahy ◽  
Elizabeth E. Davenport

Recent technological advances in the management of patients with cardiovascular implantable electronic devices (CIEDs) have expanded clinicians’ ability to remotely monitor patients with CIEDs. Remote monitoring, in addition to periodic in-person device evaluation, provides many advantages to patients and clinicians. Aside from the therapeutic and diagnostic benefits of pacemakers, implantable cardioverter-defibrillators, cardiac resynchronization therapy devices, and implantable loop recorders, improvement in clinical outcomes, clinical efficiencies, and patient experience can be realized with the adoption of remote CIED monitoring. These advantages create significant value to both patients and CIED follow-up centers.


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