548 10. Pogue J, Walter SD, Yusuf S. Evaluating the benefit of event adjudication of cardiovascular outcomes in large simple RCTs. Clin Trials 2009;6:239 – 251. 11. Alexander JH, Levy E, Lawrence J, Hanna M, Waclawski AP, Wang J, Califf RM, Wallentin L, Granger CB. Documentation of study medication dispensing in a prospective large randomized clinical trial: experiences from the ARISTOTLE Trial. Am Heart J 2013;166:559 –565.e1. 12. EMA. Reflection Paper on Risk-based Quality Management in Clinical Trials. http:// www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/ 2011/08/WC500110059.pdf (9 July 2013). 13. FDA. Guidance for Industry Oversight of Clinical Investigations—A Risk-Based Approach to Monitoring (Draft Aug 2011). http://www.fda.gov/downloads/Drugs/.../ Guidances/UCM269919.pdf (9 July 2013). 14. Mega JL, Braunwald E, Wiviott SD, Bassand JP, Bhatt DL, Bode C, Burton P, Cohen M, Cook-Bruns N, Fox KA, Goto S, Murphy SA, Plotnikov AN, Schneider D, Sun X, Verheugt FW, Gibson CM. Rivaroxaban in patients with a recent acute coronary syndrome. NEJM 2012;366:9 –19.
G. Calvo et al.
15. FDA Briefing Document for the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) for Xareltow (Rivaroxaban) Oral Tablets; 2012. http:// www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeeting Materials/Drugs/CardiovascularandRenalDrugsAdvisoryCommittee/ UCM304755.pdf#page=192 (9 July 2013). 16. ICH Topic E 6 (R1). Good Clinical Practice: Consolidated Guidance. http://www.ich. org/products/guidelines/efficacy/efficacy-single/article/good-clinical-practice. html (9 July 2013). 17. Clinical Trials Transformation Initiative. http://www.trialstransformation.org (17 September 2013). 18. Proposal for a Regulation of the European Parliament and of the Council on Clinical Trials on Medicinal Products for Human Use, and Repealing Directive 2001/20/EC. http://ec. europa.eu/health/files/clinicaltrials/2012_07/proposal/2012_07_proposal_ en.pdf. 19. Hemminki A, Kellokumpu-Lehtinen PL. Harmful impact of EU clinical trials directive. BMJ 2006;332:501 – 502.
CARDIOVASCULAR FLASHLIGHT
doi:10.1093/eurheartj/eht412 Online publish-ahead-of-print 16 October 2013
.............................................................................................................................................................................
Spyridon Gkaniatsas1, Philipp D. Gaudron1, Tobias Gassenmaier2, Meinrad Beer2,3, Frank Weidemann1,4, and Peter Nordbeck1,4* 1 Department of Internal Medicine I, University Hospital Wu¨rzburg, Oberdu¨rrbacher Str. 6, 97080, Wu¨rzburg, Germany; 2Department of Radiology, University Hospital Wu¨rzburg, Wu¨rzburg,Germany; 3Department of Radiology, Medical University Graz, Graz, Austria; and 4Comprehensive Heart Failure Center, University of Wu¨rzburg, Wu¨rzburg,Germany
* Corresponding author. Tel: +49 9312010, Fax: +49 931201639708, Email: [email protected]
A 53-year-old patient called the emergency due to persistent thoracic pain and dizziness. The medical history of the patient and that of his family were inconspicuous. The initial ECG showed a ventricular tachycardia of 210 b.p.m., which was terminated by external cardioversion. The patient was thereafter referred to our hospital. After conversion to sinus rhythm, the ECG showed peripheral low voltage with negative T-waves in V2–V6 (Panels A and B). Blood testing revealed a six-fold increase in CK (10% CK-MB), highly elevated GOT, LDH, and Troponin, and a mild increase in C-reactive protein. Chest X-ray showed an enlarged heart (C), and bedside echocardiography suggested an impairment of left lateral wall movement, and mild, haemodynamically not relevant circular pericardial effusion. After exclusion of coronary artery disease by cardiac angiography, laevocardiography showed only mild reduction of systolic function but suggested diaphragmal enlargement of the myocardium with denoted mid-ventricular constriction of the apex (Panels D and E). A second echocardiography confirmed a confined swelling of the left lateral wall, suggesting a cardiac tumour (Panels F and G). Cardiac magnetic resonance imaging was then performed, showing isolated thickening (4 cm maximum) of the left ventricular free/lateral wall (Panels H and I ). Myocardial tissue characterization showed no infiltration, oedema, or necrosis, but revealed a smoothly delineated mass with almost homogeneous high signal intensities in the late enhancement imaging in this area, suggesting an atypical form of hypertrophic cardiomyopathy (Panels J and K). This preliminary diagnosis was soon validated comparing the current findings with previous examinations of the patient .10 years ago that also showed isolated left ventricular free wall hypertrophy. In this first clinical manifestation, myocardial biopsy and investigation of pericardial effusion had shown massive hypertrophy but no malign cells or inflammation. Therefore, no further diagnostics were conducted, and the patient received an implantable cardiac defibrillator for secondary prevention of ventricular tachycardia. The patient could be dismissed from the hospital in good physical health, and until then encountered no further ventricular tachycardia. Published on behalf of the European Society of Cardiology. All rights reserved. & The Author 2013. For permissions please email: [email protected]
Downloaded from http://eurheartj.oxfordjournals.org/ by guest on November 14, 2015
Atypical hypertrophic cardiomyopathy of the left lateral wall leading to ventricular tachycardia
G. Calvo et al.
15. FDA Briefing Document for the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) for Xareltow (Rivaroxaban) Oral Tablets; 2012. http:// www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeeting Materials/Drugs/CardiovascularandRenalDrugsAdvisoryCommittee/ UCM304755.pdf#page=192 (9 July 2013). 16. ICH Topic E 6 (R1). Good Clinical Practice: Consolidated Guidance. http://www.ich. org/products/guidelines/efficacy/efficacy-single/article/good-clinical-practice. html (9 July 2013). 17. Clinical Trials Transformation Initiative. http://www.trialstransformation.org (17 September 2013). 18. Proposal for a Regulation of the European Parliament and of the Council on Clinical Trials on Medicinal Products for Human Use, and Repealing Directive 2001/20/EC. http://ec. europa.eu/health/files/clinicaltrials/2012_07/proposal/2012_07_proposal_ en.pdf. 19. Hemminki A, Kellokumpu-Lehtinen PL. Harmful impact of EU clinical trials directive. BMJ 2006;332:501 – 502.
CARDIOVASCULAR FLASHLIGHT
doi:10.1093/eurheartj/eht412 Online publish-ahead-of-print 16 October 2013
.............................................................................................................................................................................
Spyridon Gkaniatsas1, Philipp D. Gaudron1, Tobias Gassenmaier2, Meinrad Beer2,3, Frank Weidemann1,4, and Peter Nordbeck1,4* 1 Department of Internal Medicine I, University Hospital Wu¨rzburg, Oberdu¨rrbacher Str. 6, 97080, Wu¨rzburg, Germany; 2Department of Radiology, University Hospital Wu¨rzburg, Wu¨rzburg,Germany; 3Department of Radiology, Medical University Graz, Graz, Austria; and 4Comprehensive Heart Failure Center, University of Wu¨rzburg, Wu¨rzburg,Germany
* Corresponding author. Tel: +49 9312010, Fax: +49 931201639708, Email: [email protected]
A 53-year-old patient called the emergency due to persistent thoracic pain and dizziness. The medical history of the patient and that of his family were inconspicuous. The initial ECG showed a ventricular tachycardia of 210 b.p.m., which was terminated by external cardioversion. The patient was thereafter referred to our hospital. After conversion to sinus rhythm, the ECG showed peripheral low voltage with negative T-waves in V2–V6 (Panels A and B). Blood testing revealed a six-fold increase in CK (10% CK-MB), highly elevated GOT, LDH, and Troponin, and a mild increase in C-reactive protein. Chest X-ray showed an enlarged heart (C), and bedside echocardiography suggested an impairment of left lateral wall movement, and mild, haemodynamically not relevant circular pericardial effusion. After exclusion of coronary artery disease by cardiac angiography, laevocardiography showed only mild reduction of systolic function but suggested diaphragmal enlargement of the myocardium with denoted mid-ventricular constriction of the apex (Panels D and E). A second echocardiography confirmed a confined swelling of the left lateral wall, suggesting a cardiac tumour (Panels F and G). Cardiac magnetic resonance imaging was then performed, showing isolated thickening (4 cm maximum) of the left ventricular free/lateral wall (Panels H and I ). Myocardial tissue characterization showed no infiltration, oedema, or necrosis, but revealed a smoothly delineated mass with almost homogeneous high signal intensities in the late enhancement imaging in this area, suggesting an atypical form of hypertrophic cardiomyopathy (Panels J and K). This preliminary diagnosis was soon validated comparing the current findings with previous examinations of the patient .10 years ago that also showed isolated left ventricular free wall hypertrophy. In this first clinical manifestation, myocardial biopsy and investigation of pericardial effusion had shown massive hypertrophy but no malign cells or inflammation. Therefore, no further diagnostics were conducted, and the patient received an implantable cardiac defibrillator for secondary prevention of ventricular tachycardia. The patient could be dismissed from the hospital in good physical health, and until then encountered no further ventricular tachycardia. Published on behalf of the European Society of Cardiology. All rights reserved. & The Author 2013. For permissions please email: [email protected]
Downloaded from http://eurheartj.oxfordjournals.org/ by guest on November 14, 2015
Atypical hypertrophic cardiomyopathy of the left lateral wall leading to ventricular tachycardia
