Safety of performing endomyocardial biopsy in patients with suspected amyloid cardiomyopathy

S. Schwarting (München)¹, S. Spethmann (Berlin)², K. Hahn (Berlin)³, G. Barzen (Berlin)⁴, C. Morbach (Würzburg)⁵, M. Steinhardt (Würzburg)⁶, V. Cejka (Würzburg)⁷, N. Donhauser (Erlangen)⁸, M. Tröbs (Erlangen)⁹, L. Ottelé (München)¹⁰, K. Knoll (München)¹¹, T. Trenkwalder (München)¹¹, M. Poledniczek (Wien)¹², F. Duca (Wien)¹³, M. Schäfer (Köln)¹⁴, R. Pfister (Köln)¹⁴, L. Schlender (Frankfurt am Main)¹⁵, A. Bulgakova (Frankfurt am Main)¹⁶, M. Papathanasiou (Frankfurt am Main)¹⁵, B. Aßmus (Gießen)¹⁷, N. Majunke (Leipzig)¹⁸, D. Lavall (Leipzig)¹⁹, S. Kääb (München)¹, S. Massberg (München)¹, N. Frey (Heidelberg)²⁰, F. aus dem Siepen (Heidelberg)²⁰
¹LMU Klinikum der Universität München Medizinische Klinik und Poliklinik I München, Deutschland; ²Charité - Universitätsmedizin Berlin Klinik für Kardiologie, Angiologie und Intensivmedizin Berlin, Deutschland; ³Klinik für Neurologie Amyloidosis Center Charite Berlin Berlin, Deutschland; ⁴Amyloidosis Center Charité Berlin (ACCB), Deutsches Herzzentrum der Charité, Charité - Universitätsmedizin Berlin Klinik für Kardiologie, Angiologie und Intensivmedizin Berlin, Deutschland; ⁵Universitätsklinikum Würzburg Medizinische Klinik I, Kardiologie Würzburg, Deutschland; ⁶University Hospital Würzburg nterdisciplinary Amyloidosis Center of Northern Bavaria Würzburg, Deutschland; ⁷Universitätsklinikum Würzburg Deutsches Zentrum für Herzinsuffizienz/DZHI Würzburg, Deutschland; ⁸Universitätsklinikum Erlangen Medizinische Klinik 2 Erlangen, Deutschland; ⁹Universitätsklinikum Erlangen Medizinische Klinik 2 Erlangen, Deutschland; ¹⁰Deutsches Herzzentrum München München, Deutschland; ¹¹Deutsches Herzzentrum München Klinik für Herz- und Kreislauferkrankungen München, Deutschland; ¹²Wien, Deutschland; ¹³Universitätsklinikum AKH Wien Medizinische - Universität Wien Innere Medizin II, Klinische Abteilung für Kardiologie Wien, Österreich; ¹⁴Herzzentrum der Universität zu Köln Klinik III für Innere Medizin Köln, Deutschland; ¹⁵Universitätsklinikum Frankfurt Med. Klinik III - Kardiologie, Angiologie Frankfurt am Main, Deutschland; ¹⁶Universtitätsmedizin Frankfurt Medizinische Klinik III Frankfurt am Main, Deutschland; ¹⁷Universitätsklinikum Gießen und Marburg GmbH Medizinische Klinik I - Kardiologie und Angiologie Gießen, Deutschland; ¹⁸Leipzig, Deutschland; ¹⁹Universitätsklinikum Leipzig Klinik und Poliklinik für Kardiologie Leipzig, Deutschland; ²⁰Universitätsklinikum Heidelberg Klinik für Innere Med. III, Kardiologie, Angiologie u. Pneumologie Heidelberg, Deutschland

Background/Introduction: According to current ESC and ACC/AHA guidelines, endomyocardial biopsy (EMB) is indicated in patients with suspected amyloid cardiomyopathy, particularly in the presence of positive immunofixation, a low Perugini score (0–1), or persistent clinical suspicion despite noninvasive testing. However, due to varying levels of experience with this invasive diagnostic procedure across different centers, clinical evidence regarding its periprocedural safety remains limited. Patients with amyloidosis frequently present with conduction or pacing abnormalities secondary to fibril deposition, which fuels the debate about the overall risk–benefit ratio of the procedure.

Purpose: This multicenter, retrospective observational study aims to assess the safety of myocardial biopsy in patients with suspected amyloid cardiomyopathy. The primary endpoint was the cumulative incidence of periprocedural complications. These included major, life-threatening complications such as ventricular tachycardia in need of defibrillation, stroke, pericardial tamponade requiring intervention, newly implanted electronical devices within 30 days after EMB or periprocedural high-grade atrioventricular block. Minor complications included pericardial effusion, new occurrence of atrioventricular valve regurgitation and premature ventricular complexes.

Methods/Results: Overall, 520 patients from 12 centers were included in the analysis. Median age at the time of EMB was 77 [72, 81] years. The cohort comprised 17% female patients. At the first center visit, about two thirds of the patients presented with symptoms of advanced heart failure (NYHA III-IV). On average, four biopsy specimens were obtained, predominantly from the left ventricular septum. EMB revealed diagnosis of transthyretin amyloid cardiomyopathy (ATTR-CM) in 424 patients, light-chain amyloidosis (AL-CM) in 68 patients and other amyloid types in 28 patients, respectively. Periprocedural complications occurred in 71 (13.7%) patients, with major and minor events contributing almost equally (38 and 33 cases, respectively). The most frequent major complication was the need of implantable electronic devices within 30 days after EMB (3.7%) followed by the development of a pericardial tamponade requiring emergency intervention (3.5%). No deaths were reported in relation to the EMB procedure. Complications were not associated with amyloid subtype, center size or its experience in EMB (measured as average EMB procedures per year and number of experienced interventionalists), or biopsy location.

Conclusion: This study reports EMB-associated complications in a cohort of patients with suspicion of cardiac amyloidosis. Overall, incidence of life-threatening complications was higher than previously reported in larger cohorts with EMB performed for clinical work-up of cardiomyopathy. Further analyses, such as deep echo- and electrocardiographic phenotyping are warranted to enable individual risk stratification allowing for personalized counseling on potential procedural risks.

Safety of performing endomyocardial biopsy in patients with suspected amyloid cardiomyopathy

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