The MERIDIAN trial: caution is needed - The Lancet

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May 27, 2017 - avoid unnecessary health-care costs. We declare no competing interests. *Dario Paladini, Gustavo Malinger,. Gianluigi Pilu, Ilan Timor-Trisch,.
Correspondence

GWR declares no competing interests. CPC has received grants from Arisaph, AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, GlaxoSmithKline, Merck, and Takeda; and consulting fees from Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, GlaxoSmithKline, Kowa, Merck, Takeda, Lipimedix, Pfizer, Regeneron, and Sanofi.

*Grant W Reed, Christopher P Cannon [email protected] Cardiovascular Medicine, Cleveland Clinic, Cleveland, OH 44147, USA (GWR); and Cardiovascular Division, Brigham and Women’s Hospital, Harvard Medical School, Baim Institute for Clinical Research, Boston, MA, USA (CPC) 1 2

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Reed GW, Rossi JE, Cannon CP. Acute myocardial infarction. Lancet 2017; 389: 197–210. Armstrong PW, Gershlick AH, Goldstein P, et al, for the STREAM Investigative Team. Fibrinolysis or primary PCI in ST-segment elevation myocardial infarction. N Engl J Med 2013; 368: 1379–87. Authors/Task Force members, Windecker S, Kolh P, Alfonso F, et al. 2014 ESC/EACTS guidelines on myocardial revascularization: the task force on myocardial revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS) developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J 2014; 35: 2541–619. American College of Emergency Physicians, Society for Cardiovascular Angiography and Interventions, O’Gara PT, Kushner FG, Ascheim DD, et al. 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction. J Am Coll Cardiol 2013; 61: e78–140.

The MERIDIAN trial: caution is needed We congratulate Paul Griffiths and colleagues (Feb 4, p 538)1 for their Article showing that in-utero MRI changed prognostic information in at least 20% of cases of fetal brain abnormalities, and led to changes in clinical management in over a third of cases compared with ultrasound. However, we have several concerns about this Article. Notably, what is meant by ultra­ sound is not described. International guidelines and numerous fetal medi­cine experts agree that, in cases of suspected CNS anomalies, a detailed assessment of the fetal brain should be performed with transvaginal ultra­sound, if feasible, www.thelancet.com Vol 389 May 27, 2017

to benefit from the higher resolution of transvaginal transducers.2 This approach boosts the diagnostic accuracy,3,4 and reduces the clinical usefulness of subsequent MRI to less than 10%.4 From the limited information provided on ultrasound in this Article, it could be argued that transvaginal ultrasound was never used. Indeed, the fact that the fetal head was deep within the pelvis—a factor favouring transvaginal ultrasound—is paradoxically stated by the authors as a source of reduced diagnostic accuracy for ultrasound. The limited neurosonographic experience (22 cases per year with no transvaginal approach) might be responsible for the unusually high clinical usefulness of MRI, as in another article by Griffiths and colleagues5 in which malformations as overt as holoprosencephaly were overlooked at ultrasound. We suggest that the diagnostic path of fetal CNS anomalies should be from screening to neurosonography.2–4 MRI should represent a second-line resource to be employed in selected cases, and only after expert neurosonography, to avoid unnecessary health-care costs. We declare no competing interests.

*Dario Paladini, Gustavo Malinger, Gianluigi Pilu, Ilan Timor-Trisch, Paolo Volpe [email protected] Fetal Medicine and Surgery Unit, Istituto Giannina Gaslini, 16148 Genoa, Italy (DP); OB-GYN Ultrasound Unit, Lis Maternity Hospital, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel (GM); Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel (GM); Department of Obstetrics and Gynecology, University of Bologna, Bologna, Italy (GP); Division of Obstetrical & Gynecological Ultrasound, Department of Obstetrics and Gynecology, NYU School of Medicine, New York, NY, USA (IT-T); Fetal Medicine Unit, Venere Hospital, Bari, Italy (PV); and M Sarcone Hospital, Terlizzi, Bari, Italy (PV) 1

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Griffiths PD, Bradburn M, Campbell MJ, et al, for the MERIDIAN collaborative group. Use of MRI in the diagnosis of fetal brain abnormalities in utero (MERIDIAN): a multicentre, prospective cohort study. Lancet 2016; 389: 538–46. International Society of Ultrasound in Obstetrics & Gynecology Education Committee. Sonographic examination of the fetal central nervous system: guidelines for performing the ‘basic examination’ and the ‘fetal neurosonogram’. Ultrasound Obstet Gynecol 2007; 29: 109–16.

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Paladini D, Quarantelli M, Sglavo G, et al. Accuracy of neurosonography and MRI in clinical management of fetuses referred with central nervous system abnormalities. Ultrasound Obstet Gynecol 2014; 44: 188–96. Malinger G, Ben-Sira L, Lev D, Ben-Aroya Z, Kidron D, Lerman-Sagie T. Fetal brain imaging: a comparison between magnetic resonance imaging and dedicated neurosonography. Ultrasound Obstet Gynecol 2004; 23: 333–40. Whitby EH, Paley MN, Sprigg A, et al. Comparison of ultrasound and magnetic resonance imaging in 100 singleton pregnancies with suspected brain abnormalities. BJOG 2004; 111: 784–92.

Artificial trachea transplantation is not ready for patients Although one assignment of a uni­ versity hospital is to develop health care, the safety of each and every patient treated can never be challenged. There­fore, I, as the Chief Executive Officer of Karolinska University Hos­ pital, feel the urge to share the lessons learned from the world’s first artificial trachea transplantations in patients. Paolo Macchiarini was employed by Karolinska University Hospital, Sweden, as a senior physician in 2010– 13, and as a professor at Karolinska Institute, Sweden. During his employment, Macchiarini transplanted synthetic tracheas prepared with bone marrow cells in three patients. The first patient died 30 months after the procedure following severe complications from the synthetic trachea. The second patient died after 4 months from an unknown cause. The third patient had severe complications that required continuous hospital care for 4·5 years before she died in early 2017. These poor results led to doubt regarding the readiness of this new technique. An external investigation was initiated with three major findings: methods and techniques used should have been regarded as clinical research and subjected to ethical review; should it have been subjected to ethical review, it would not have been approved; and the method used by Macchiarini at

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for ST-segment elevation myocardial infarction.3,4

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