Novel Method Combines Heart Biopsy and Device Implantation to Reduce Risk of Complications and Support Early Diagnosis of Heart Conditions

Endomyocardial biopsy (EMB) is a valuable method for diagnosing a range of cardiac conditions, but there is a risk of complication due to its invasive nature. Researchers have now found a way to combine right ventricular (RV) septal EMB, exploiting the benefit of 3D curved conduction system pacing (CSP) sheaths, with subsequent cardiac implantable electronic device (CIED, devices like pacemakers or defibrillators to regulate heart rhythm) implantation, using the same sheath. Two articles in Heart Rhythm opens in new tab/window, the official journal of the Heart Rhythm Society, the Cardiac Electrophysiology Society, and the Pediatric & Congenital Electrophysiology Society, published by Elsevier, demonstrate the feasibility and safety of this novel method.

EMB carries a complication risk of up to 3%. It is usually performed only when noninvasive methods fail to provide a definitive diagnosis or necessary histology, which may lead to diagnostic delays. This novel streamlined process reduces the risk of complications. It also allows doctors to diagnose heart conditions like cardiomyopathy and heart failure earlier, enabling them to start treatment sooner, which can improve the patient's outcome. Additionally, early diagnosis can help identify genetic causes of the heart condition, which can benefit other family members.

John Silberbauer, MA, MD(Res), FRCP, Sussex Cardiac Centre, Brighton, UK, first author of the accompanying editorial commentary "Pace and Biopsy opens in new tab/window," explains, "Improving the ease, diagnostic yield, and the safety profile of EMB may enable earlier diagnosis and treatment of a range of cardiac conditions, bringing us closer to how other medical specialties manage tissue diagnoses. The two articles in Heart Rhythm detail the researchers' experiences in combining RV septal EMB, exploiting the benefit of 3D CSP sheaths, with subsequent CIED implantation, using the same sheath. The use of these novel CSP sheaths allowed more accurate and upfront RV septal apposition, making concomitant biopsy a quick and safe add-on to the planned device implantation."

Lead investigator Kenji Kuroki, MD, Department of Cardiovascular Medicine, University of Yamanashi, Chuo, Japan, says, "Our study "Novel technique and assessment of available 3-dimensional delivery  opens in new tab/window

sheath for endomyocardial biopsy during cardiac device implantation opens in new tab/window" demonstrated the usefulness and safety of the new method for performing EMB in 20 patients using a 3-dimensional delivery sheath during CIED implantation. Additionally, it enabled the early diagnosis of previously undetected cardiac amyloidosis (CA) in 4 patients (20%), as confirmed by pathologic findings. Subclinical CA may often be overlooked among patients with CIED implantation. Early diagnosis could enable the timely initiation of appropriate treatment, making this finding particularly important."

Patients for whom CIED is indicated can face complications like cardiomyopathy or other unspecified cardiac abnormalities and may need EMB. However, EMB by a bioptome, a tool to extract tissue samples from the heart, is usually avoided to reduce the risk of lead displacement in the CIED peri-procedural period, following EMB guidelines.

In the study "Feasibility and safety of endomyocardial biopsy by lumenless pacing lead sheath–directed method during cardiac implantable electronic device implantation opens in new tab/window," 80 patients referred for EMB were enrolled to assess the safety and feasibility of a novel approach for transvenous RV EMB using the lead sheath method (L-S-M) during CIED implantation, comparing it with the traditional bioptome method (T-B-M).

Lead investigator Yang Ye, MD, PhD, Department of Cardiology, Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University, Hangzhou, China, notes, "Using cardiac pacing leads instead of traditional myocardial biopsy forceps during the implantation could be timesaving and cost-effective without compromising safety. In addition, it has the advantages of requiring only one vessel for both EMB and CIED implantation. In this study, no ventricular perforations or serious cardiac event occurred, demonstrating a safe L-S-M procedure of EMB."

Coauthor of the study Guosheng Fu, MD, PhD, Department of Cardiology, Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University, Hangzhou, China, adds, “Our study demonstrated that RV EMB by the innovative L-S-M method is technically feasible and safe, and able to yield valuable and early diagnosis for patients who are candidates for CIEDs as well as being cost-effective without needing extra tools for EMB."

Dr. Silberbauer concludes, "These two studies demonstrate that opportunistic EMB is feasible and safe using fixed 3D curved CSP sheaths that are designed to reach the RV septum. In selected patients requiring CIED, this method may, in the future, enable a more definitive and earlier diagnosis for patients with cardiomyopathies and heart failure, which may facilitate earlier instigation of prognosis-modifying therapies, genetic testing, and cascade screening. The big questions will be, for whom is ‘pace and biopsy’ the right approach, who is qualified to do it, and where will this novel approach lead us?"

Notes for editors

The articles are:

“Novel technique and assessment of available 3-dimensional delivery sheath for endomyocardial biopsy during cardiac device implantation," by Koji Sudo, MD, Kenji Kuroki, MD, Kazuto Nakamura, MD, Yosuke Watanabe, MD, Manabu Uematsu, MD, Chisa Asahina, MD, Yuya Tanaka, MD, Tsuyoshi Kobayashi, MD, and Akira Sato, MD (https://doi.org/10.1016/j.hrthm.2024.10.069 opens in new tab/window). It is openly available at https://www.heartrhythmjournal.com/article/S1547-5271(24)03534-3/fulltext opens in new tab/window.

Journalists wishing to interview the authors should contact Kenji Kuroki, MD, at [email protected] opens in new tab/window.

“Feasibility and safety of endomyocardial biopsy by lumenless pacing lead sheath–directed method during cardiac implantable electronic device implantation," by Yang Ye, MD, PhD, FHRS, Youyou Chen, MD, Hao Jiang, MD, Jiling Zeng, MD, Xingchen Wang, MD, Ying Yang, MD, PhD, Xiang Lan Liu, MD, PhD, XuLin Hong, MD, PhD, Bei Wang, MD, Ya Xun Sun, MD, PhD, Dongwu Lai, MD, PhD, Xi-qi Xu, MD, PhD, and Guo-sheng Fu, MD, PhD (https://doi.org/10.1016/j.hrthm.2024.11.018 opens in new tab/window). It is openly available for 30 days at https://www.heartrhythmjournal.com/article/S1547-5271(24)03571-9/fulltext opens in new tab/window.

Journalists wishing to interview the authors should contact Yang Ye, MD, PhD, FHRS, at [email protected] opens in new tab/window.

The editorial commentary is "Pace and Biopsy," by John Silberbauer, MA, MD(Res), FRCP, Christopher Pavitt, MD, MRCP, Alexander Liu, MD, MRCP, and Christopher Bruce, MBChB, MRCP (https://doi.org/10.1016/j.hrthm.2024.11.049 opens in new tab/window). It is openly available for 30 days at https://www.heartrhythmjournal.com/article/S1547-5271(24)03633-6/fulltext opens in new tab/window.

Journalists wishing to interview the authors should contact John Silberbauer, MA, MD(Res), FRCP, at [email protected] opens in new tab/window.

The articles appear online in advance of Heart Rhythm, volume 22, Issue 4 (April 2025), published by Elsevier.

Full text of the articles is also available to credentialed journalists upon request; contact Jane Grochowski at +1 406 542 8397 or [email protected] opens in new tab/window.

About Heart Rhythm

Heart Rhythm opens in new tab/window, the official Journal of the Heart Rhythm Society opens in new tab/window, the Cardiac Electrophysiology Society opens in new tab/window, and the Pediatric & Congenital Electrophysiology Society opens in new tab/window, is a unique journal for fundamental discovery and clinical applicability. It integrates the entire cardiac electrophysiology (EP) community from basic and clinical academic researchers, private practitioners, engineers, allied professionals, industry, and trainees, all of whom are vital and interdependent members of our EP community. www.heartrhythmjournal.com opens in new tab/window

About the Heart Rhythm Society

The Heart Rhythm Society opens in new tab/window is the international leader in science, education, and advocacy for cardiac arrhythmia professionals and patients, and the primary information resource on heart rhythm disorders. Its mission is to improve the care of patients by promoting research, education, and optimal healthcare policies and standards. The Heart Rhythm Society is the preeminent professional group representing more than 8,000 specialists in cardiac pacing and electrophysiology from more than 94 countries. www.HRsonline.org opens in new tab/window

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