Challenges in cardiac device innovation: Is neuroimaging an appropriate endpoint? Consensus from the 2013 Yale-UCL Cardiac Device Innovation Summit

BMC Medicine

Volumn 11, Issue 1, 2013, Pages

  Meller, Stephanie M ^a   Baumbach, Andreas ^b   Voros, Szilard ^c   Mullen, Michael ^d   Lansky, Alexandra J ^a  

^a YALE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b UNIVERSITY HOSPITALS BRISTOL NHS FOUNDATION TRUST   (United Kingdom)

^c STONY BROOK UNIVERSITY MEDICAL CENTER   (United States)

^d UNIVERSITY COLLEGE LONDON   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ACETYLSALICYLIC ACID; CLOPIDOGREL; HIRULOG; WARFARIN;

AORTA STENOSIS; ARTICLE; BRAIN ISCHEMIA; CARDIOVASCULAR EQUIPMENT; CONSENSUS; DIFFUSION WEIGHTED IMAGING; EMBOLIC PROTECTION DEVICE; HEART ATRIUM FIBRILLATION; HUMAN; NEUROIMAGING; NEUROPROTECTION; SAMPLE SIZE; TRANSCATHETER AORTIC VALVE IMPLANTATION;

AGED, 80 AND OVER; AORTIC VALVE; BRAIN; CARDIAC CATHETERIZATION; DIFFUSION MAGNETIC RESONANCE IMAGING; EMBOLIC PROTECTION DEVICES; HEART VALVE PROSTHESIS IMPLANTATION; HUMANS; INTRACRANIAL EMBOLISM; MALE; NEUROIMAGING; TREATMENT OUTCOME;

EID: 84890211339     PISSN: None     EISSN: 17417015     Source Type: Journal    
DOI: 10.1186/1741-7015-11-257     Document Type: Article

References (42)

1. Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med 2010, 363:1597-1607. 10.1056/NEJMoa1008232, 20961243.
2. Kodali SK, Williams MR, Smith CR, Svensson LG, Webb JG, Makkar RR, Fontana GP, Dewey TM, Thourani VH, Pichard AD, Fischbein M, Szeto WY, Lim S, Greason KL, Teirstein PS, Malaisrie SC, Douglas PS, Hahn RT, Whisenant B, Zajarias A, Wang D, Akin JJ, Anderson WN, Leon MB. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med 2012, 366:1686-1695. 10.1056/NEJMoa1200384, 22443479.
3. Masson JB, Kovac J, Schuler G, Ye J, Cheung A, Kapadia S, Tuzcu ME, Kodali S, Leon MB, Webb JG. Transcatheter aortic valve implantation: review of the nature, management, and avoidance of procedural complications. JACC Cardiovasc Interv 2009, 2:811-820. 10.1016/j.jcin.2009.07.005, 19778768.
4. Nuis RJ, Piazza N, Van Mieghem NM, Otten AM, Tzikas A, Schultz CJ, van der Boon R, van Geuns RJ, van Domburg RT, Koudstaal PJ, Kappetein AP, Serruys PW, de Jaegere PP. In-hospital complications after transcatheter aortic valve implantation revisited according to the valve academic research consortium definitions. Catheter Cardiovasc Interv 2011, 78:457-467.
5. Lefevre F, Koskela J, Hubert J, Kraigher H, Longauer R, Olrik DC, Schuler S, Bozzano M, Alizoti P, Bakys R, Baldwin C, Ballian D, Black-Samuelsson S, Bednarova D, Bordacs S, Collin E, De Cuyper B, De Vries SM, Eysteinsson T, Frydl J, Haverkamp M, Ivankovic M, Konrad H, Koziol C, Maaten T, Paino EN, Ozturk H, Pandeva ID, Parnuta G, Pilipovic A, et al. Dynamic conservation of forest genetic resources in 33 European countries. Conserv Biol 2013, 27:373-384. 10.1111/j.1523-1739.2012.01961.x, 23240629.
6. Dvir D, Barbash IM, Ben-Dor I, Okubagzi P, Satler LF, Waksman R, Pichard AD. The development of transcatheter aortic valve replacement in the USA. Arch Cardiovasc Dis 2012, 105:160-164. 10.1016/j.acvd.2012.02.003, 22520799.
7. Eggebrecht H, Schmermund A, Voigtlander T, Kahlert P, Erbel R, Mehta RH. Risk of stroke after transcatheter aortic valve implantation (TAVI): a meta-analysis of 10,037 published patients. EuroIntervention 2012, 8:129-138. 10.4244/EIJV8I1A20, 22391581.
8. Khatri PJ, Webb JG, Rodes-Cabau J, Fremes SE, Ruel M, Lau K, Guo H, Wijeysundera HC, Ko DT. Adverse effects associated with transcatheter aortic valve implantation: a meta-analysis of contemporary studies. Ann Intern Med 2013, 158:35-46. 10.7326/0003-4819-158-1-201301010-00007, 23277899.
9. Vasques F, Messori A, Lucenteforte E, Biancari F. Immediate and late outcome of patients aged 80 years and older undergoing isolated aortic valve replacement: a systematic review and meta-analysis of 48 studies. Am Heart J 2012, 163:477-485. 10.1016/j.ahj.2011.12.005, 22424020.
10. Panchal HB, Ladia V, Desai S, Shah T, Ramu V. A meta-analysis of mortality and major adverse cardiovascular and cerebrovascular events following transcatheter aortic valve implantation versus surgical aortic valve replacement for severe aortic stenosis. Am J Cardiol 2013, 112:850-860. 10.1016/j.amjcard.2013.05.015, 23756547.
11. Avanzas P, Munoz-Garcia AJ, Segura J, Pan M, Alonso-Briales JH, Lozano I, Moris C, Suarez de Lezo J, Hernandez-Garcia JM. Percutaneous implantation of the CoreValve self-expanding aortic valve prosthesis in patients with severe aortic stenosis: early experience in Spain. Rev Esp Cardiol 2010, 63:141-148. 10.1016/S0300-8932(10)70031-2, 20109412.
12. Gurvitch R, Tay EL, Wijesinghe N, Ye J, Nietlispach F, Wood DA, Lichtenstein S, Cheung A, Webb JG. Transcatheter aortic valve implantation: lessons from the learning curve of the first 270 high-risk patients. Catheter Cardiovasc Interv 2011, 78:977-984. 10.1002/ccd.22961, 21656647.
13. Tay EL, Gurvitch R, Wijesinghe N, Nielispach F, Wood D, Cheung A, Ye J, Lichtenstein SV, Carere R, Thompson C, Webb JG. A high-risk period for cerebrovascular events exists after transcatheter aortic valve implantation. JACC Cardiovasc Interv 2011, 4:1290-1297. 10.1016/j.jcin.2011.08.012, 22192370.
14. Arnold M, Schulz-Heise S, Achenbach S, Ott S, Dorfler A, Ropers D, Feyrer R, Einhaus F, Loders S, Mahmoud F, Roerick O, Daniel WG, Weyand M, Ensminger SM, Ludwig J. Embolic cerebral insults after transapical aortic valve implantation detected by magnetic resonance imaging. JACC Cardiovasc Interv 2010, 3:1126-1132. 10.1016/j.jcin.2010.09.008, 21087747.
15. Kahlert P, Knipp SC, Schlamann M, Thielmann M, Al-Rashid F, Weber M, Johansson U, Wendt D, Jakob HG, Forsting M, Sack S, Erbel R, Eggebrecht H. Silent and apparent cerebral ischemia after percutaneous transfemoral aortic valve implantation: a diffusion-weighted magnetic resonance imaging study. Circulation 2010, 121:870-878. 10.1161/CIRCULATIONAHA.109.855866, 20177005.
16. Astarci P, Glineur D, Kefer J, D'Hoore W, Renkin J, Vanoverschelde JL, El Khoury G, Grandin C. Magnetic resonance imaging evaluation of cerebral embolization during percutaneous aortic valve implantation: comparison of transfemoral and trans-apical approaches using Edwards Sapiens valve. Eur J Cardiothorac Surg 2011, 40:475-479.
17. Meller SM, Baumbach A, Brickman AM, Lansky AJ. Clinical implications for diffusion-weighted MRI brain lesions associated with transcatheter aortic valve replacement. Catheter Cardiovasc Interv In press.
18. Brodaty H, McGilchrist C, Harris L, Peters KE. Time until institutionalization and death in patients with dementia. Role of caregiver training and risk factors. Arch Neurol 1993, 50:643-650. 10.1001/archneur.1993.00540060073021, 8503802.
19. Bleiziffer S, Mazzitelli D, Opitz A, Hettich I, Ruge H, Piazza N, Lange R. Beyond the short-term: clinical outcome and valve performance 2 years after transcatheter aortic valve implantation in 227 patients. J Thorac Cardiovasc Surg 2012, 143:310-317. 10.1016/j.jtcvs.2011.10.060, 22137802.
20. Ussia GP, Barbanti M, Petronio AS, Tarantini G, Ettori F, Colombo A, Violini R, Ramondo A, Santoro G, Klugmann S, Bedogni F, Maisano F, Marzocchi A, Poli A, De Carlo M, Napodano M, Fiorina C, De Marco F, Antoniucci D, de Cillis E, Capodanno D, Tamburino C. Transcatheter aortic valve implantation: 3-year outcomes of self-expanding corevalve prosthesis. Eur Heart J 2012, 33:969-976. 10.1093/eurheartj/ehr491, 22240494.
21. Wendler O, Thielmann M, Schroefel H, Rastan A, Treede H, Wahlers T, Eichinger W, Walther T. Worldwide experience with the 29-mm Edwards SAPIEN XTTM transcatheter heart valve in patients with large aortic annulus. Eur J Cardiothorac Surg 2013, 43:371-377. 10.1093/ejcts/ezs203, 22522982.
22. Ringer TM, Neumann-Haefelin T, Sobel RA, Moseley ME, Yenari MA. Reversal of early diffusion-weighted magnetic resonance imaging abnormalities does not necessarily reflect tissue salvage in experimental cerebral ischemia. Stroke 2001, 32:2362-2369. 10.1161/hs1001.096058, 11588327.
23. Ussia GP, Scarabelli M, Mule M, Barbanti M, Sarkar K, Cammalleri V, Imme S, Aruta P, Pistritto AM, Gulino S, Deste W, Capodanno D, Tamburino C. Dual antiplatelet therapy versus aspirin alone in patients undergoing transcatheter aortic valve implantation. Am J Cardiol 2011, 108:1772-1776. 10.1016/j.amjcard.2011.07.049, 21907949.
24. Hansen ML, Sorensen R, Clausen MT, Fog-Petersen ML, Raunso J, Gadsboll N, Gislason GH, Folke F, Andersen SS, Schramm TK, Abildstrom SZ, Poulsen HE, Kober L, Torp-Pedersen C. Risk of bleeding with single, dual, or triple therapy with warfarin, aspirin, and clopidogrel in patients with atrial fibrillation. Arch Intern Med 2010, 170:1433-1441.
25. Sergie Z, Lefevre T, Van Belle E, Kakoulides S, Baber U, Deliargyris EN, Mehran R, Grube E, Reinohl J, Dangas GD. Current periprocedural anticoagulation in transcatheter aortic valve replacement: could bivalirudin be an option? Rationale and design of the BRAVO 2/3 studies. J Thromb Thrombolysis 2013, 35:483-493. 10.1007/s11239-013-0890-3, 23553245.
26. Nietlispach F, Wijesinghe N, Gurvitch R, Tay E, Carpenter JP, Burns C, Wood DA, Webb JG. An embolic deflection device for aortic valve interventions. JACC Cardiovasc Interv 2010, 3:1133-1138. 10.1016/j.jcin.2010.05.022, 21087748.
27. Naber CK, Ghanem A, Abizaid AA, Wolf A, Sinning JM, Werner N, Nickenig G, Schmitz T, Grube E. First-in-man use of a novel embolic protection device for patients undergoing transcatheter aortic valve implantation. EuroIntervention 2012, 8:43-50. 10.4244/EIJV8I1A8, 22403768.
28. Onsea K, Agostoni P, Samim M, Voskuil M, Kluin J, Budde R, Hendrikse J, Ramjankhan F, van Klarenbosch J, Doesburg P, Sieswerda G, Stella P. First-in-man experience with a new embolic deflection device in transcatheter aortic valve interventions. EuroIntervention 2012, 8:51-56. 10.4244/EIJV8I1A9, 22580248.
29. Ghanem A, Muller A, Nahle CP, Kocurek J, Werner N, Hammerstingl C, Schild HH, Schwab JO, Mellert F, Fimmers R, Nickenig G, Thomas D. Risk and fate of cerebral embolism after transfemoral aortic valve implantation: a prospective pilot study with diffusion-weighted magnetic resonance imaging. J Am Coll Cardiol 2010, 55:1427-1432. 10.1016/j.jacc.2009.12.026, 20188503.
30. Knipp SC, Matatko N, Schlamann M, Wilhelm H, Thielmann M, Forsting M, Diener HC, Jakob H. Small ischemic brain lesions after cardiac valve replacement detected by diffusion-weighted magnetic resonance imaging: relation to neurocognitive function. Eur J Cardiothorac Surg 2005, 28:88-96. 10.1016/j.ejcts.2005.02.043, 15922616.
31. Drews T, Pasic M, Buz S, Unbehaun A, Dreysse S, Kukucka M, Mladenow A, Hetzer R. Transcranial Doppler sound detection of cerebral microembolism during transapical aortic valve implantation. Thorac Cardiovasc Surg 2011, 59:237-242. 10.1055/s-0030-1250495, 21442580.
32. Sarkar S, Ghosh S, Ghosh SK, Collier A. Role of transcranial Doppler ultrasonography in stroke. Postgrad Med J 2007, 83:683-689. 10.1136/pgmj.2007.058602, 2659960, 17989267.
33. Lovblad KO, Pluschke W, Remonda L, Gruber-Wiest D, Do DD, Barth A, Kniemeyer HW, Bassetti C, Mattle HP, Schroth G. Diffusion-weighted MRI for monitoring neurovascular interventions. Neuroradiology 2000, 42:134-138. 10.1007/s002340050032, 10663492.
34. Kappetein AP, Head SJ, Genereux P, Piazza N, van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA, Hahn RT, Kirtane AJ, Krucoff MW, Kodali S, Mack MJ, Mehran R, Rodes-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the valve academic research consortium-2 consensus document (VARC-2). Eur J Cardiothorac Surg 2012, 42:S45-S60. 10.1093/ejcts/ezs533, 23026738.
35. Chalela JA, Kidwell CS, Nentwich LM, Luby M, Butman JA, Demchuk AM, Hill MD, Patronas N, Latour L, Warach S. Magnetic resonance imaging and computed tomography in emergency assessment of patients with suspected acute stroke: a prospective comparison. Lancet 2007, 369:293-298. 10.1016/S0140-6736(07)60151-2, 1859855, 17258669.
36. Rodes-Cabau J, Dumont E, Boone RH, Larose E, Bagur R, Gurvitch R, Bedard F, Doyle D, De Larochelliere R, Jayasuria C, Villeneuve J, Marrero A, Cote M, Pibarot P, Webb JG. Cerebral embolism following transcatheter aortic valve implantation: comparison of transfemoral and transapical approaches. J Am Coll Cardiol 2011, 57:18-28. 10.1016/j.jacc.2010.07.036, 21185496.
37. Ghanem A, Muller A, Sinning JM, Kocurek J, Becker BV, Vogel M, Vasa-Nicotera M, Hammerstingl C, Schwab JO, Nahle CP, Thomas D, Wagner M, Grube E, Werner N, Nickenig G. Prognostic value of cerebral injury following transfemoral aortic valve implantation. EuroIntervention 2013, 8:1296-1306. 10.4244/EIJV8I11A198, 23538093.
38. Knipp SC, Kahlert P, Jokisch D, Schlamann M, Wendt D, Weimar C, Jakob H, Thielmann M. Cognitive function after transapical aortic valve implantation: a single-centre study with 3-month follow-up. Interact Cardiovasc Thorac Surg 2013, 16:116-122. 10.1093/icvts/ivs461, 23148084.
39. Thijs VN, Lansberg MG, Beaulieu C, Marks MP, Moseley ME, Albers GW. Is early ischemic lesion volume on diffusion-weighted imaging an independent predictor of stroke outcome? A multivariable analysis. Stroke 2000, 31:2597-2602. 10.1161/01.STR.31.11.2597, 11062281.
40. Lovblad KO, Baird AE, Schlaug G, Benfield A, Siewert B, Voetsch B, Connor A, Burzynski C, Edelman RR, Warach S. Ischemic lesion volumes in acute stroke by diffusion-weighted magnetic resonance imaging correlate with clinical outcome. Ann Neurol 1997, 42:164-170. 10.1002/ana.410420206, 9266725.
41. Choi SH, Na DL, Chung CS, Lee KH, Na DG, Adair JC. Diffusion-weighted MRI in vascular dementia. Neurology 2000, 54:83-89. 10.1212/WNL.54.1.83, 10636130.
42. Chodosh EH, Foulkes MA, Kase CS, Wolf PA, Mohr JP, Hier DB, Price TR, Furtado JG. Silent stroke in the NINCDS stroke data bank. Neurology 1988, 38:1674-1679. 10.1212/WNL.38.11.1674, 3185900.