574660
research-article2015
TAK0010.1177/1753944715574660Therapeutic Advances in Cardiovascular DiseaseT Konecny, PA Noseworthy
Therapeutic Advances in Cardiovascular Disease
Endomyocardial biopsy-integrating electrode at the bioptome tip Tomas Konecny, Peter A. Noseworthy, Suraj Kapa, Leslie T. Cooper, Siva K. Mulpuru, Gurpreet S. Sandhu and Samuel Asirvatham
Original Research
Ther Adv Cardiovasc Dis 2015, Vol. 9(3) 66–69 DOI: 10.1177/ 1753944715574660 © The Author(s), 2015. Reprints and permissions: http://www.sagepub.co.uk/ journalsPermissions.nav
Abstract Background: The addition of electroanatomic mapping to a standard echo-guided endomyocardial biopsy could identify areas of abnormal pathology and increase the diagnostic yield of the procedure. Methods and results: In this demonstration of a novel technique, a 45-year-old woman with clinical suspicion for cardiac sarcoidosis underwent right ventricular bipolar electroanatomical mapping with identification of areas of signal fractionation and low voltage. A bioptome, configured to record an electrogram from the tip, was then visualized on the three-dimensional electroanatomic mapping (3DEAM) system, and directed to these areas. The biopsy was assisted by the use of a steerable introducer sheath, and by recording unipolar and extended bipolar signals from the bioptome tip. A prominent change in the signal was detected by the electrode at the bioptome tip when the jaws closed on the endomyocardial tissue. Patient tolerated the procedure without complications, and the biopsied samples were appropriate for pathological analysis. Conclusions: Using existing technology, the 3DEAM, which integrates unipolar and bipolar signal from the bioptome tip, is feasible, and can be safely added to a standard echocardiographically guided endomyocardial biopsy. Future studies should investigate whether such a technique could increase the safety and diagnostic yield of endomyocardial biopsies in patients with suspected cardiomyopathies.
Keywords: electroanatomic mapping, endomyocardial biopsy
Introduction A timely diagnosis and categorization of myocardial pathology has therapeutic and prognostic implications with crucial importance to the understanding of the underlying cardiomyopathy [Bennett et al. 2013]. The endomyocardial biopsy (EMB) guided by fluoroscopic and echocardiographic guidance carries a relatively low complication risk profile [Cooper et al. 2007], but its diagnostic yield in patients with a nonuniform, patchy myocardial disease distribution (e.g. sarcoidosis, focal myocarditis) remains modest [Cooper et al. 2007; From et al. 2011; Bennett et al. 2013]. Identification of fractionated and low-voltage electrograms by three-dimensional endocardial electroanatomical mapping (3DEAM) can localize the areas of myocardium affected by pathology, and pilot data support the
notion that EMB based on 3DEAM can improve the diagnostic yield [Sasaki et al. 2013; Liang et al. 2014]. Visualization of the bioptome in realtime on 3DEAM as well as the recording of both unipolar and bipolar electrograms from the bioptome tip would help in increasing the effectiveness and safe ascertainment of analyzable tissue. Procedure Preparation After providing informed consent, the procedure was performed under conscious sedation in the electrophysiological laboratory equipped with fluoroscopy, transthoracic echocardiography, and the 3DEAM system (EnSite NavX, St Jude Medical, Minnetonka, MN, USA). Vascular
Correspondence to: Peter A. Noseworthy, MD Division of Cardiovascular Diseases and Internal Medicine, Mayo Clinic, Rochester, MN, USA noseworthy.peter@mayo. edu Tomas Konecny, MD, PhD Division of Cardiovascular Diseases and Internal Medicine, Mayo Clinic, Rochester, MN, USA and International Clinical Research Center (ICRC) of St. Anne’s University Hospital, Brno, Czech Republic Suraj Kapa, MD Leslie T. Cooper, Jr, MD Siva K. Mulpuru, MD Gurpreet S. Sandhu, MD, PhD Division of Cardiovascular Diseases and Internal Medicine, Mayo Clinic, Rochester, MN, USA Samuel J. Asirvatham, MD Division of Cardiovascular Diseases, Mayo Clinic College of Medicine 200 First Street SW, Rochester, MN 55905, USA
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Figure 1. (a) and (b) Connection of the disposable biopsy forceps (Bipal 7, 7 Fr × 104 cm) to the electroanatomic mapping system allows for visualization of unipolar and bipolar electrograms from the bioptome tip while leaving the ability to close and open the forceps unhindered (c). The connection between the bioptome tip and bioptome handle was tested prior to the procedure, and showed reliable conduction of electrical signals.
access with two short sheaths in the right femoral vein (8 Fr, 9 Fr) was obtained, and a radial arterial line was placed for hemodynamic monitoring. A steerable flexible long sheath (Agilis NxT 9.5 Fr, lumen length 91 cm, St Jude Medical) was exchanged for the 9 Fr short sheath and advanced to the heart over a wire under fluoroscopic guidance. A long 8 Fr SR0 sheath was exchanged for the 8 Fr short sheath and advanced to the right atrium in a similar fashion. A mapping catheter with standard bidirectional curves (Blazer EPT 5 mm tip, 7 Fr × 110 cm, Boston Scientific, San Jose, CA, USA) was connected to the 3DEAM and threaded via the SR0 sheath to the right ventricle (RV). Biopsy forceps (Bipal 7, 7 Fr × 104 cm, Cordis Corporation, Miami Lakes, FL, USA) were connected to the 3DEAM (Figure 1) to allow for the recording of unipolar signals (cathode: bioptome tip; anode: Wilson’s central terminal), and bipolar signals (cathode: bioptome tip; anode: EPT mapping catheter tip [Abl d]). Mapping and biopsy The RV was mapped by the EPT catheter and the 3DEAM model identified locations with abnormally fractionated near-field signals and low-voltage signals (red and orange colored areas in
Figure 2a). The area situated at the midventricular septum was deemed amenable for a safe biopsy retrieval (black asterisk in Figure 2a), and the EPT catheter tip was positioned to its close proximity. The bioptome was then advanced by the steerable sheath so that its tip was aimed at the area of interest using guidance by fluoroscopy and 3DEAM (Figure 2a–2d ). Unipolar (bioptome tip to Wilson’s central terminal) and an extended bipole (bioptome tip to the nearby EPT catheter tip) tracings from the bioptome confirmed fractionated electrograms (Figure 2d), and visualization of the bioptome against the interventricular septum by transthoracic echocardiogram was performed for additional safety. When the bioptome jaws were closed on the endomyocardial tissue, a prominent change in the detected signal was recorded (Figure 3). A total of five biopsy samples were obtained using this technique and were subsequently judged as sufficient for analysis by the pathologist: they revealed a fibrotic endocardium with mildly hypertrophied myocytes without inflammation or granuloma. Discussion Using existing technology, this demonstration of a novel technique supports the plausibility of
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Therapeutic Advances in Cardiovascular Disease 9(3)
Figure 2. (a) Electroanatomical voltage map of the right ventricular endocardium. The left anterior oblique view (left side of the panel) depicts the zone of lower fractionated voltage (labeled area of interest, black asterisk) identified during mapping with the distal bipole of the EPT catheter. The right anterior oblique view (right side of the panel) shows additional areas of low voltage that were located on the lateral aspect of the right ventricle (RV), and therefore, deemed not safe for endomyocardial biopsy. (b) and (c) Fluoroscopic left anterior oblique (b) and right anterior oblique (c) views of the procedural set up at the time of biopsy, depicting the biopsy forceps (empty white arrow) threaded to the RV by a long steerable flexible introducer sheath (Agilis NxT 8.5 F, lumen length 91 cm) and aimed at the RV septum. (d) Three-dimensional electroanatomical map identifying the tip of the bioptome as a green marker in the area of interest (empty white arrow), while the EPT catheter (full white arrow) remains nearby. Recorded tracings at the bottom of the panel represent surface lead I (I), distal bipole on the EPT catheter (Abl d), proximal bipole on the EPT catheter (Abl p), unipolar recording from the bioptome tip (Bio uni), and bipolar recording between the bioptome tip and the distal electrode on the EPT catheter (Bio-Abl). PA, pulmonary artery; RV, right ventricle; RVOT, right ventricular outflow tract; TV, tricuspid valve.
integrating a bioptome with 3DEAM during a standard echocardiographically guided biopsy. The novel findings from this report are: (a) the bioptome tip can be connected with the 3DEAM system without compromising the functionality of the forceps; (b) a flexible long sheath helps in improving the maneuverability of the bioptome in the RV; (c) simultaneous visualization of the bioptome and the reference catheter is possible in real
time during the biopsy; (d) unipolar and bipolar recordings help to confirm the appropriate location just before biopsy ascertainment; (e) an electrogram recorded by the bioptome changes acutely when the jaws close tightly on the endomyocardial tissue, which may help identify a ‘good grab’ (sufficient tissue enclosed in the forceps amenable for retrieval). Future studies should investigate whether the technique could provide increased
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T Konecny, PA Noseworthy et al.
Figure 3. Unipolar tracing from the bioptome tip revealed an abrupt change in the electrogram (full gray arrows) soon after the bioptome jaws closed on the endocardium (asterisk).
yield and safety of endomyocardial biopsies in patients with suspected cardiomyopathies. Acknowledgements We would like to thank the following individuals for their contributions to this project: Mr Stephen Heinrich (St Jude Medical), Mr Zach Koch (St Jude Medical) and Mrs Lisa Fanning (Mayo Clinic). Funding This study was supported in part by the Mayo Clinic Foundation and the European Regional Development Fund – Project FNUSA-ICRC (No. CZ.1.05/1.1.00/02.0123). Conflict of interest statement None of the authors reports any relevant conflicts of interest. References Bennett, M., Gilotra, N., Harrington, C., Rao, S., Dunn, J., Freitag, T. et al. (2013) Evaluation of the role of endomyocardial biopsy in 851 patients with
unexplained heart failure from 2000–2009. Circ Heart Fail 6: 676–684. Cooper, L., Baughman, K., Feldman, A., Frustaci, A., Jessup, M., Kuhl, U. et al. (2007) The role of endomyocardial biopsy in the management of cardiovascular disease: a scientific statement from the American Heart Association, the American College of Cardiology, and the European Society of Cardiology. Endorsed by the Heart Failure Society of America and the Heart Failure Association of the European Society of Cardiology. J Am Coll Cardiol 50: 1914–1931. From, A., Maleszewski, J. and Rihal, C. (2011) Current status of endomyocardial biopsy. Mayo Clin Proc 86: 1095–1102. Liang, J., Hebl, V., DeSimone, C., Madhavan, M., Nanda, S., Kapa, S. et al. (2014) Electrogramguidance: a method to increase the precision and diagnostic yield of endomyocardial biopsy for suspected cardiac sarcoidosis and myocarditis. JACC Heart Fail 2: 466–473. Sasaki, T., Miller, C., Hansford, R., Zipunnikov, V., Zviman, M., Marine, J. et al. (2013) Impact of nonischemic scar features on local ventricular electrograms and scar-related ventricular tachycardia circuits in patients with nonischemic cardiomyopathy. Circ Arrhythm Electrophysiol 6: 1139–1147.
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research-article2015
TAK0010.1177/1753944715574660Therapeutic Advances in Cardiovascular DiseaseT Konecny, PA Noseworthy
Therapeutic Advances in Cardiovascular Disease
Endomyocardial biopsy-integrating electrode at the bioptome tip Tomas Konecny, Peter A. Noseworthy, Suraj Kapa, Leslie T. Cooper, Siva K. Mulpuru, Gurpreet S. Sandhu and Samuel Asirvatham
Original Research
Ther Adv Cardiovasc Dis 2015, Vol. 9(3) 66–69 DOI: 10.1177/ 1753944715574660 © The Author(s), 2015. Reprints and permissions: http://www.sagepub.co.uk/ journalsPermissions.nav
Abstract Background: The addition of electroanatomic mapping to a standard echo-guided endomyocardial biopsy could identify areas of abnormal pathology and increase the diagnostic yield of the procedure. Methods and results: In this demonstration of a novel technique, a 45-year-old woman with clinical suspicion for cardiac sarcoidosis underwent right ventricular bipolar electroanatomical mapping with identification of areas of signal fractionation and low voltage. A bioptome, configured to record an electrogram from the tip, was then visualized on the three-dimensional electroanatomic mapping (3DEAM) system, and directed to these areas. The biopsy was assisted by the use of a steerable introducer sheath, and by recording unipolar and extended bipolar signals from the bioptome tip. A prominent change in the signal was detected by the electrode at the bioptome tip when the jaws closed on the endomyocardial tissue. Patient tolerated the procedure without complications, and the biopsied samples were appropriate for pathological analysis. Conclusions: Using existing technology, the 3DEAM, which integrates unipolar and bipolar signal from the bioptome tip, is feasible, and can be safely added to a standard echocardiographically guided endomyocardial biopsy. Future studies should investigate whether such a technique could increase the safety and diagnostic yield of endomyocardial biopsies in patients with suspected cardiomyopathies.
Keywords: electroanatomic mapping, endomyocardial biopsy
Introduction A timely diagnosis and categorization of myocardial pathology has therapeutic and prognostic implications with crucial importance to the understanding of the underlying cardiomyopathy [Bennett et al. 2013]. The endomyocardial biopsy (EMB) guided by fluoroscopic and echocardiographic guidance carries a relatively low complication risk profile [Cooper et al. 2007], but its diagnostic yield in patients with a nonuniform, patchy myocardial disease distribution (e.g. sarcoidosis, focal myocarditis) remains modest [Cooper et al. 2007; From et al. 2011; Bennett et al. 2013]. Identification of fractionated and low-voltage electrograms by three-dimensional endocardial electroanatomical mapping (3DEAM) can localize the areas of myocardium affected by pathology, and pilot data support the
notion that EMB based on 3DEAM can improve the diagnostic yield [Sasaki et al. 2013; Liang et al. 2014]. Visualization of the bioptome in realtime on 3DEAM as well as the recording of both unipolar and bipolar electrograms from the bioptome tip would help in increasing the effectiveness and safe ascertainment of analyzable tissue. Procedure Preparation After providing informed consent, the procedure was performed under conscious sedation in the electrophysiological laboratory equipped with fluoroscopy, transthoracic echocardiography, and the 3DEAM system (EnSite NavX, St Jude Medical, Minnetonka, MN, USA). Vascular
Correspondence to: Peter A. Noseworthy, MD Division of Cardiovascular Diseases and Internal Medicine, Mayo Clinic, Rochester, MN, USA noseworthy.peter@mayo. edu Tomas Konecny, MD, PhD Division of Cardiovascular Diseases and Internal Medicine, Mayo Clinic, Rochester, MN, USA and International Clinical Research Center (ICRC) of St. Anne’s University Hospital, Brno, Czech Republic Suraj Kapa, MD Leslie T. Cooper, Jr, MD Siva K. Mulpuru, MD Gurpreet S. Sandhu, MD, PhD Division of Cardiovascular Diseases and Internal Medicine, Mayo Clinic, Rochester, MN, USA Samuel J. Asirvatham, MD Division of Cardiovascular Diseases, Mayo Clinic College of Medicine 200 First Street SW, Rochester, MN 55905, USA
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T Konecny, PA Noseworthy et al.
Figure 1. (a) and (b) Connection of the disposable biopsy forceps (Bipal 7, 7 Fr × 104 cm) to the electroanatomic mapping system allows for visualization of unipolar and bipolar electrograms from the bioptome tip while leaving the ability to close and open the forceps unhindered (c). The connection between the bioptome tip and bioptome handle was tested prior to the procedure, and showed reliable conduction of electrical signals.
access with two short sheaths in the right femoral vein (8 Fr, 9 Fr) was obtained, and a radial arterial line was placed for hemodynamic monitoring. A steerable flexible long sheath (Agilis NxT 9.5 Fr, lumen length 91 cm, St Jude Medical) was exchanged for the 9 Fr short sheath and advanced to the heart over a wire under fluoroscopic guidance. A long 8 Fr SR0 sheath was exchanged for the 8 Fr short sheath and advanced to the right atrium in a similar fashion. A mapping catheter with standard bidirectional curves (Blazer EPT 5 mm tip, 7 Fr × 110 cm, Boston Scientific, San Jose, CA, USA) was connected to the 3DEAM and threaded via the SR0 sheath to the right ventricle (RV). Biopsy forceps (Bipal 7, 7 Fr × 104 cm, Cordis Corporation, Miami Lakes, FL, USA) were connected to the 3DEAM (Figure 1) to allow for the recording of unipolar signals (cathode: bioptome tip; anode: Wilson’s central terminal), and bipolar signals (cathode: bioptome tip; anode: EPT mapping catheter tip [Abl d]). Mapping and biopsy The RV was mapped by the EPT catheter and the 3DEAM model identified locations with abnormally fractionated near-field signals and low-voltage signals (red and orange colored areas in
Figure 2a). The area situated at the midventricular septum was deemed amenable for a safe biopsy retrieval (black asterisk in Figure 2a), and the EPT catheter tip was positioned to its close proximity. The bioptome was then advanced by the steerable sheath so that its tip was aimed at the area of interest using guidance by fluoroscopy and 3DEAM (Figure 2a–2d ). Unipolar (bioptome tip to Wilson’s central terminal) and an extended bipole (bioptome tip to the nearby EPT catheter tip) tracings from the bioptome confirmed fractionated electrograms (Figure 2d), and visualization of the bioptome against the interventricular septum by transthoracic echocardiogram was performed for additional safety. When the bioptome jaws were closed on the endomyocardial tissue, a prominent change in the detected signal was recorded (Figure 3). A total of five biopsy samples were obtained using this technique and were subsequently judged as sufficient for analysis by the pathologist: they revealed a fibrotic endocardium with mildly hypertrophied myocytes without inflammation or granuloma. Discussion Using existing technology, this demonstration of a novel technique supports the plausibility of
http://tac.sagepub.com 67
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Therapeutic Advances in Cardiovascular Disease 9(3)
Figure 2. (a) Electroanatomical voltage map of the right ventricular endocardium. The left anterior oblique view (left side of the panel) depicts the zone of lower fractionated voltage (labeled area of interest, black asterisk) identified during mapping with the distal bipole of the EPT catheter. The right anterior oblique view (right side of the panel) shows additional areas of low voltage that were located on the lateral aspect of the right ventricle (RV), and therefore, deemed not safe for endomyocardial biopsy. (b) and (c) Fluoroscopic left anterior oblique (b) and right anterior oblique (c) views of the procedural set up at the time of biopsy, depicting the biopsy forceps (empty white arrow) threaded to the RV by a long steerable flexible introducer sheath (Agilis NxT 8.5 F, lumen length 91 cm) and aimed at the RV septum. (d) Three-dimensional electroanatomical map identifying the tip of the bioptome as a green marker in the area of interest (empty white arrow), while the EPT catheter (full white arrow) remains nearby. Recorded tracings at the bottom of the panel represent surface lead I (I), distal bipole on the EPT catheter (Abl d), proximal bipole on the EPT catheter (Abl p), unipolar recording from the bioptome tip (Bio uni), and bipolar recording between the bioptome tip and the distal electrode on the EPT catheter (Bio-Abl). PA, pulmonary artery; RV, right ventricle; RVOT, right ventricular outflow tract; TV, tricuspid valve.
integrating a bioptome with 3DEAM during a standard echocardiographically guided biopsy. The novel findings from this report are: (a) the bioptome tip can be connected with the 3DEAM system without compromising the functionality of the forceps; (b) a flexible long sheath helps in improving the maneuverability of the bioptome in the RV; (c) simultaneous visualization of the bioptome and the reference catheter is possible in real
time during the biopsy; (d) unipolar and bipolar recordings help to confirm the appropriate location just before biopsy ascertainment; (e) an electrogram recorded by the bioptome changes acutely when the jaws close tightly on the endomyocardial tissue, which may help identify a ‘good grab’ (sufficient tissue enclosed in the forceps amenable for retrieval). Future studies should investigate whether the technique could provide increased
68 http://tac.sagepub.com
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T Konecny, PA Noseworthy et al.
Figure 3. Unipolar tracing from the bioptome tip revealed an abrupt change in the electrogram (full gray arrows) soon after the bioptome jaws closed on the endocardium (asterisk).
yield and safety of endomyocardial biopsies in patients with suspected cardiomyopathies. Acknowledgements We would like to thank the following individuals for their contributions to this project: Mr Stephen Heinrich (St Jude Medical), Mr Zach Koch (St Jude Medical) and Mrs Lisa Fanning (Mayo Clinic). Funding This study was supported in part by the Mayo Clinic Foundation and the European Regional Development Fund – Project FNUSA-ICRC (No. CZ.1.05/1.1.00/02.0123). Conflict of interest statement None of the authors reports any relevant conflicts of interest. References Bennett, M., Gilotra, N., Harrington, C., Rao, S., Dunn, J., Freitag, T. et al. (2013) Evaluation of the role of endomyocardial biopsy in 851 patients with
unexplained heart failure from 2000–2009. Circ Heart Fail 6: 676–684. Cooper, L., Baughman, K., Feldman, A., Frustaci, A., Jessup, M., Kuhl, U. et al. (2007) The role of endomyocardial biopsy in the management of cardiovascular disease: a scientific statement from the American Heart Association, the American College of Cardiology, and the European Society of Cardiology. Endorsed by the Heart Failure Society of America and the Heart Failure Association of the European Society of Cardiology. J Am Coll Cardiol 50: 1914–1931. From, A., Maleszewski, J. and Rihal, C. (2011) Current status of endomyocardial biopsy. Mayo Clin Proc 86: 1095–1102. Liang, J., Hebl, V., DeSimone, C., Madhavan, M., Nanda, S., Kapa, S. et al. (2014) Electrogramguidance: a method to increase the precision and diagnostic yield of endomyocardial biopsy for suspected cardiac sarcoidosis and myocarditis. JACC Heart Fail 2: 466–473. Sasaki, T., Miller, C., Hansford, R., Zipunnikov, V., Zviman, M., Marine, J. et al. (2013) Impact of nonischemic scar features on local ventricular electrograms and scar-related ventricular tachycardia circuits in patients with nonischemic cardiomyopathy. Circ Arrhythm Electrophysiol 6: 1139–1147.
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