Advertisement

Cerebral Embolic Protection Devices During TAVI

  • Zouhair Rahhab
  • Nicolas M. Van Mieghem
Chapter

Abstract

Stroke after transcatheter aortic valve implantation (TAVI) remains a critical procedural complication that is associated with increased morbidity and mortality. MRI studies have shown new ischemic lesions in almost all TAVI patients; however, only a minority of these lesions manifest in acute clinical symptoms. These so-called “silent infarcts” may affect neurocognitive function and increase the risk for future clinical strokes: Prior injuries may make the brain more vulnerable to developing clinical strokes and may accelerate the risk of dementia. More than half of all clinical strokes after TAVI occur within 48 h. Embolic protection devices are designed to protect the brain from per-procedural cerebral embolization during endovascular procedures; however, in TAVI its clinical benefit remains to be explored. Strokes more than 48 h after TAVI seem to be related to pre-existing or new-onset atrial fibrillation. Oral anticoagulation regimens may affect events related to new-onset atrial fibrillation post-TAVI. Several trials are underway evaluating the role of oral anticoagulation post-TAVI.

References

  1. 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, Investigators PT. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010;363(17):1597–607.CrossRefPubMedGoogle Scholar
  2. 2.
    Makkar RR, Fontana GP, Jilaihawi H, Kapadia S, Pichard AD, Douglas PS, Thourani VH, Babaliaros VC, Webb JG, Herrmann HC, Bavaria JE, Kodali S, Brown DL, Bowers B, Dewey TM, Svensson LG, Tuzcu M, Moses JW, Williams MR, Siegel RJ, Akin JJ, Anderson WN, Pocock S, Smith CR, Leon MB, Investigators PT. Transcatheter aortic-valve replacement for inoperable severe aortic stenosis. N Engl J Med. 2012;366(18):1696–704.CrossRefPubMedGoogle Scholar
  3. 3.
    Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Williams M, Dewey T, Kapadia S, Babaliaros V, Thourani VH, Corso P, Pichard AD, Bavaria JE, Herrmann HC, Akin JJ, Anderson WN, Wang D, Pocock SJ, Investigators PT. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011;364(23):2187–98.CrossRefPubMedGoogle Scholar
  4. 4.
    Leon MB, Smith CR, Mack MJ, Makkar RR, Svensson LG, Kodali SK, Thourani VH, Tuzcu EM, Miller DC, Herrmann HC, Doshi D, Cohen DJ, Pichard AD, Kapadia S, Dewey T, Babaliaros V, Szeto WY, Williams MR, Kereiakes D, Zajarias A, Greason KL, Whisenant BK, Hodson RW, Moses JW, Trento A, Brown DL, Fearon WF, Pibarot P, Hahn RT, Jaber WA, Anderson WN, Alu MC, Webb JG, Investigators P. Transcatheter or surgical aortic-valve replacement in intermediate-risk patients. N Engl J Med. 2016;374(17):1609–20.CrossRefPubMedGoogle Scholar
  5. 5.
    Nuis RJ, Van Mieghem NM, Schultz CJ, Moelker A, van der Boon RM, van Geuns RJ, van der Lugt A, Serruys PW, Rodes-Cabau J, van Domburg RT, Koudstaal PJ, de Jaegere PP. Frequency and causes of stroke during or after transcatheter aortic valve implantation. Am J Cardiol. 2012;109(11):1637–43.CrossRefPubMedGoogle Scholar
  6. 6.
    Tchetche D, Farah B, Misuraca L, Pierri A, Vahdat O, Lereun C, Dumonteil N, Modine T, Laskar M, Eltchaninoff H, Himbert D, Iung B, Teiger E, Chevreul K, Lievre M, Lefevre T, Donzeau-Gouge P, Gilard M, Fajadet J. Cerebrovascular events post-transcatheter aortic valve replacement in a large cohort of patients: a FRANCE-2 registry substudy. JACC Cardiovasc Interv. 2014;7(10):1138–45.CrossRefPubMedGoogle Scholar
  7. 7.
    Nombela-Franco L, Webb JG, de Jaegere PP, Toggweiler S, Nuis RJ, Dager AE, Amat-Santos IJ, Cheung A, Ye J, Binder RK, van der Boon RM, Van Mieghem N, Benitez LM, Perez S, Lopez J, San Roman JA, Doyle D, Delarochelliere R, Urena M, Leipsic J, Dumont E, Rodes-Cabau J. Timing, predictive factors, and prognostic value of cerebrovascular events in a large cohort of patients undergoing transcatheter aortic valve implantation. Circulation. 2012;126(25):3041–53.CrossRefPubMedGoogle Scholar
  8. 8.
    Adams DH, Popma JJ, Reardon MJ, Yakubov SJ, Coselli JS, Deeb GM, Gleason TG, Buchbinder M, Hermiller J Jr, Kleiman NS, Chetcuti S, Heiser J, Merhi W, Zorn G, Tadros P, Robinson N, Petrossian G, Hughes GC, Harrison JK, Conte J, Maini B, Mumtaz M, Chenoweth S, Oh JK, Investigators USCC. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med. 2014;370(19):1790–8.CrossRefPubMedGoogle Scholar
  9. 9.
    Jilaihawi H, Chakravarty T, Weiss RE, Fontana GP, Forrester J, Makkar RR. Meta-analysis of complications in aortic valve replacement: comparison of Medtronic-Corevalve, Edwards-Sapien and surgical aortic valve replacement in 8,536 patients. Catheter Cardiovasc Interv. 2012;80(1):128–38.CrossRefPubMedGoogle Scholar
  10. 10.
    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. J Am Coll Cardiol. 2012;60(15):1438–54.CrossRefPubMedGoogle Scholar
  11. 11.
    Athappan G, Gajulapalli RD, Sengodan P, Bhardwaj A, Ellis SG, Svensson L, Tuzcu EM, Kapadia SR. Influence of transcatheter aortic valve replacement strategy and valve design on stroke after transcatheter aortic valve replacement: a meta-analysis and systematic review of literature. J Am Coll Cardiol. 2014;63(20):2101–10.CrossRefPubMedGoogle Scholar
  12. 12.
    Van Mieghem NM, Chieffo A, Dumonteil N, Tchetche D, van der Boon RM, Buchanan GL, Marcheix B, Vahdat O, Serruys PW, Fajadet J, Carrie D, Colombo A, de Jaegere PP. Trends in outcome after transfemoral transcatheter aortic valve implantation. Am Heart J. 2013;165(2):183–92.CrossRefPubMedGoogle Scholar
  13. 13.
    Popma JJ, Adams DH, Reardon MJ, Yakubov SJ, Kleiman NS, Heimansohn D, Hermiller J Jr, Hughes GC, Harrison JK, Coselli J, Diez J, Kafi A, Schreiber T, Gleason TG, Conte J, Buchbinder M, Deeb GM, Carabello B, Serruys PW, Chenoweth S, Oh JK. CoreValve United States clinical I. Transcatheter aortic valve replacement using a self-expanding bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery. J Am Coll Cardiol. 2014;63(19):1972–81.CrossRefPubMedGoogle Scholar
  14. 14.
    Amat-Santos IJ, Rodes-Cabau J, Urena M, DeLarochelliere R, Doyle D, Bagur R, Villeneuve J, Cote M, Nombela-Franco L, Philippon F, Pibarot P, Dumont E. Incidence, predictive factors, and prognostic value of new-onset atrial fibrillation following transcatheter aortic valve implantation. J Am Coll Cardiol. 2012;59(2):178–88.CrossRefPubMedGoogle Scholar
  15. 15.
    Gilard M, Eltchaninoff H, Iung B, Donzeau-Gouge P, Chevreul K, Fajadet J, Leprince P, Leguerrier A, Lievre M, Prat A, Teiger E, Lefevre T, Himbert D, Tchetche D, Carrie D, Albat B, Cribier A, Rioufol G, Sudre A, Blanchard D, Collet F, Dos Santos P, Meneveau N, Tirouvanziam A, Caussin C, Guyon P, Boschat J, Le Breton H, Collart F, Houel R, Delpine S, Souteyrand G, Favereau X, Ohlmann P, Doisy V, Grollier G, Gommeaux A, Claudel JP, Bourlon F, Bertrand B, Van Belle E, Laskar M, Investigators F. Registry of transcatheter aortic-valve implantation in high-risk patients. N Engl J Med. 2012;366(18):1705–15.CrossRefPubMedGoogle Scholar
  16. 16.
    Fanning JP, Walters DL, Platts DG, Eeles E, Bellapart J, Fraser JF. Characterization of neurological injury in transcatheter aortic valve implantation: how clear is the picture? Circulation. 2014;129(4):504–15.CrossRefPubMedGoogle Scholar
  17. 17.
    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 valveimplantation: comparison of transfemoral and transapical approaches using Edwards sapiens valve. Eur J Cardiothorac Surg. 2011;40(2):475–9.  https://doi.org/10.1016/j.ejcts.2010.11.070. Epub 20 Jan 2011CrossRefPubMedGoogle Scholar
  18. 18.
    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(4):237–42.CrossRefPubMedGoogle Scholar
  19. 19.
    Erdoes G, Basciani R, Huber C, Stortecky S, Wenaweser P, Windecker S, Carrel T, Eberle B. Transcranial Doppler-detected cerebral embolic load during transcatheter aortic valve implantation. Eur J Cardiothorac Surg. 2012;41(4):778–83. discussion 783-4CrossRefPubMedGoogle Scholar
  20. 20.
    Kahlert P, Al-Rashid F, Dottger P, Mori K, Plicht B, Wendt D, Bergmann L, Kottenberg E, Schlamann M, Mummel P, Holle D, Thielmann M, Jakob HG, Konorza T, Heusch G, Erbel R, Eggebrecht H. Cerebral embolization during transcatheter aortic valve implantation: a transcranial Doppler study. Circulation. 2012;126(10):1245–55.CrossRefPubMedGoogle Scholar
  21. 21.
    Van Mieghem NM, El Faquir N, Rahhab Z, Rodriguez-Olivares R, Wilschut J, Ouhlous M, Galema TW, Geleijnse ML, Kappetein AP, Schipper ME, de Jaegere PP. Incidence and predictors of debris embolizing to the brain during transcatheter aortic valve implantation. JACC Cardiovasc Interv. 2015;8(5):718–24.CrossRefPubMedGoogle Scholar
  22. 22.
    Van Mieghem NM, Schipper ME, Ladich E, Faqiri E, van der Boon R, Randjgari A, Schultz C, Moelker A, van Geuns RJ, Otsuka F, Serruys PW, Virmani R, de Jaegere PP. Histopathology of embolic debris captured during transcatheter aortic valve replacement. Circulation. 2013;127(22):2194–201.CrossRefPubMedGoogle Scholar
  23. 23.
    Sacco RL, Kasner SE, Broderick JP, Caplan LR, Connors JJ, Culebras A, Elkind MS, George MG, Hamdan AD, Higashida RT, Hoh BL, Janis LS, Kase CS, Kleindorfer DO, Lee JM, Moseley ME, Peterson ED, Turan TN, Valderrama AL, Vinters HV, American Heart Association Stroke Council CoCS, Anesthesia, Council on Cardiovascular Radiology, Intervention, Council on Cardiovascular, Stroke Nursing, Council on Epidemiology, Prevention, Council on Peripheral Vascular Disease, Council on Nutrition Physical Activity, Metabolism. An updated definition of stroke for the 21st century: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013;44(7):2064–89.CrossRefPubMedGoogle Scholar
  24. 24.
    Bendszus M, Stoll G. Silent cerebral ischaemia: hidden fingerprints of invasive medical procedures. Lancet Neurol. 2006;5(4):364–72.CrossRefPubMedGoogle Scholar
  25. 25.
    Vermeer SE, Hollander M, van Dijk EJ, Hofman A, Koudstaal PJ, Breteler MM, Rotterdam SS. Silent brain infarcts and white matter lesions increase stroke risk in the general population: the Rotterdam scan study. Stroke. 2003;34(5):1126–9.CrossRefPubMedGoogle Scholar
  26. 26.
    Vermeer SE, Prins ND, den Heijer T, Hofman A, Koudstaal PJ, Breteler MM. Silent brain infarcts and the risk of dementia and cognitive decline. N Engl J Med. 2003;348(13):1215–22.CrossRefPubMedGoogle Scholar
  27. 27.
    Writing Group M, Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, Das SR, de Ferranti S, Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Isasi CR, Jimenez MC, Judd SE, Kissela BM, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Magid DJ, DK MG, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Rosamond W, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Woo D, Yeh RW, Turner MB, American Heart Association Statistics Committee, Stroke Statistics Subcommittee. Heart disease and stroke statistics-2016 update: a report from the American Heart Association. Circulation. 2016;133(4):e38–60.CrossRefGoogle Scholar
  28. 28.
    Ruparelia N, Latib A, Kawamoto H, Buzzatti N, Giannini F, Figini F, Mangieri A, Regazzoli D, Stella S, Sticchi A, Tanaka A, Ancona M, Agricola E, Monaco F, Spagnolo P, Chieffo A, Montorfano M, Alfieri O, Colombo A. A comparison between first-generation and second-generation Transcatheter aortic valve implantation (TAVI) devices: a propensity-matched single-center experience. J Invasive Cardiol. 2016;28(5):210–6.PubMedGoogle Scholar
  29. 29.
    Kodali S, Thourani VH, White J, Malaisrie SC, Lim S, Greason KL, Williams M, Guerrero M, Eisenhauer AC, Kapadia S, Kereiakes DJ, Herrmann HC, Babaliaros V, Szeto WY, Hahn RT, Pibarot P, Weissman NJ, Leipsic J, Blanke P, Whisenant BK, Suri RM, Makkar RR, Ayele GM, Svensson LG, Webb JG, Mack MJ, Smith CR, Leon MB. Early clinical and echocardiographic outcomes after SAPIEN 3 transcatheter aortic valve replacement in inoperable, high-risk and intermediate-risk patients with aortic stenosis. Eur Heart J. 2016;37(28):2252–62.CrossRefPubMedGoogle Scholar
  30. 30.
    Athappan G, Gajulapalli RD, Tuzcu ME, Svensson LG, Kapadia SR. A systematic review on the safety of second-generation transcatheter aortic valves. EuroIntervention. 2016;11(9):1034–43.CrossRefPubMedGoogle Scholar
  31. 31.
    Hollander M, Koudstaal PJ, Bots ML, Grobbee DE, Hofman A, Breteler MM. Incidence, risk, and case fatality of first ever stroke in the elderly population. The Rotterdam study. J Neurol Neurosurg Psychiatry. 2003;74(3):317–21.CrossRefPubMedPubMedCentralGoogle Scholar
  32. 32.
    Lewsey JD, Gillies M, Jhund PS, Chalmers JW, Redpath A, Briggs A, Walters M, Langhorne P, Capewell S, McMurray JJ, Macintyre K. Sex differences in incidence, mortality, and survival in individuals with stroke in Scotland, 1986 to 2005. Stroke. 2009;40(4):1038–43.CrossRefPubMedGoogle Scholar
  33. 33.
    Rothwell PM, Coull AJ, Silver LE, Fairhead JF, Giles MF, Lovelock CE, Redgrave JN, Bull LM, Welch SJ, Cuthbertson FC, Binney LE, Gutnikov SA, Anslow P, Banning AP, Mant D, Mehta Z, Oxford VS. Population-based study of event-rate, incidence, case fatality, and mortality for all acute vascular events in all arterial territories (Oxford vascular study). Lancet. 2005;366(9499):1773–83.CrossRefPubMedGoogle Scholar
  34. 34.
    Carandang R, Seshadri S, Beiser A, Kelly-Hayes M, Kase CS, Kannel WB, Wolf PA. Trends in incidence, lifetime risk, severity, and 30-day mortality of stroke over the past 50 years. JAMA. 2006;296(24):2939–46.CrossRefPubMedGoogle Scholar
  35. 35.
    Al-Mubarak N, Colombo A, Gaines PA, Iyer SS, Corvaja N, Cleveland TJ, Macdonald S, Brennan C, Vitek JJ. Multicenter evaluation of carotid artery stenting with a filter protection system. J Am Coll Cardiol. 2002;39(5):841–6.CrossRefPubMedGoogle Scholar
  36. 36.
    Reimers B, Corvaja N, Moshiri S, Sacca S, Albiero R, Di Mario C, Pascotto P, Colombo A. Cerebral protection with filter devices during carotid artery stenting. Circulation. 2001;104(1):12–5.CrossRefPubMedGoogle Scholar
  37. 37.
    European Stroke Organisation, Tendera M, Aboyans V, Bartelink ML, Baumgartner I, Clement D, Collet JP, Cremonesi A, De Carlo M, Erbel R, Fowkes FG, Heras M, Kownator S, Minar E, Ostergren J, Poldermans D, Riambau V, Roffi M, Rother J, Sievert H, van Sambeek M, Zeller T, Guidelines ESCCfP. ESC guidelines on the diagnosis and treatment of peripheral artery diseases: document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteries: the task force on the diagnosis and treatment of peripheral artery diseases of the European Society of Cardiology (ESC). Eur Heart J. 2011;32(22):2851–906.CrossRefGoogle Scholar
  38. 38.
    Brott TG, Halperin JL, Abbara S, Bacharach JM, Barr JD, Bush RL, Cates CU, Creager MA, Fowler SB, Friday G, Hertzberg VS, EB MI, Moore WS, Panagos PD, Riles TS, Rosenwasser RH, Taylor AJ, American College of Cardiology, American Stroke Association, American Association of Neurological Surgeons, American College of Radiology, American American College of Radiology, Society of NeuroInterventional Surgery, Society for Vascular Medicine, Society for Vascular Surgery. 2011 ASA/ACCF/AHA/AANN/AANS/ACR/ASNR/CNS/SAIP/SCAI/SIR/SNIS/SVM/SVS guideline on the management of patients with extracranial carotid and vertebral artery disease. A report of the American College of Cardiology Foundation/American Heart Association task force on practice guidelines, and the American Stroke Association, American Association of Neuroscience Nurses, American Association of Neurological Surgeons, American College of Radiology, American Society of Neuroradiology, Congress of Neurological Surgeons, Society of Atherosclerosis Imaging and Prevention, Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, society of NeuroInterventional surgery, Society for Vascular Medicine, and Society for Vascular Surgery. Circulation. 2011;124(4):e54–130.CrossRefPubMedGoogle Scholar
  39. 39.
    Rodes-Cabau J, Kahlert P, Neumann FJ, Schymik G, Webb JG, Amarenco P, Brott T, Garami Z, Gerosa G, Lefevre T, Plicht B, Pocock SJ, Schlamann M, Thomas M, Diamond B, Merioua I, Beyersdorf F, Vahanian A. Feasibility and exploratory efficacy evaluation of the Embrella embolic deflector system for the prevention of cerebral emboli in patients undergoing transcatheter aortic valve replacement: the PROTAVI-C pilot study. JACC Cardiovasc Interv. 2014;7(10):1146–55.CrossRefPubMedGoogle Scholar
  40. 40.
    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(11):1133–8.CrossRefPubMedGoogle Scholar
  41. 41.
    Samim M, Agostoni P, Hendrikse J, Budde RP, Nijhoff F, Kluin J, Ramjankhan F, Doevendans PA, Stella PR. Embrella embolic deflection device for cerebral protection during transcatheter aortic valve replacement. J Thorac Cardiovasc Surg. 2015;149(3):799–805.CrossRefGoogle Scholar
  42. 42.
    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(1):43–50.CrossRefPubMedGoogle Scholar
  43. 43.
    Van Mieghem NM, van Gils L, Ahmad H, van Kesteren F, van der Werf HW, Brueren G, Storm M, Lenzen M, Daemen J, van den Heuvel AF, Tonino P, Baan J, Koudstaal PJ, Schipper ME, van der Lugt A, de Jaegere PP. Filter-based cerebral embolic protection with transcatheter aortic valve implantation: the randomised MISTRAL-C trial. EuroIntervention. 2016;12(4):499–507.  https://doi.org/10.4244/EIJV12I4A84.CrossRefPubMedGoogle Scholar
  44. 44.
    Haussig S, Mangner N, Dwyer MG, Lehmkuhl L, Lücke C, Woitek F, Holzhey DM, Mohr FW, Gutberlet M, Zivadinov R, Schuler G, Linke A. Effect of a cerebral protection device on brain lesions following Transcatheter aortic valve implantation in patients with severe aortic stenosis: the CLEAN-TAVI randomized clinical trial. JAMA. 2016;316(6):592–601.  https://doi.org/10.1001/jama.2016.10302.CrossRefPubMedGoogle Scholar
  45. 45.
    Kapadia SR, Kodali S, Makkar R, Mehran R, Lazar RM, Zivadinov R, Dwyer MG, Jilaihawi H, Virmani R, Anwaruddin S, Thourani VH, Nazif T, Mangner N, Woitek F, Krishnaswamy A, Mick S, Chakravarty T, Nakamura M, McCabe JM, Satler L, Zajarias A, Szeto WY, Svensson L, Alu MC, White RM, Kraemer C, Parhizgar A, Leon MB, Linke A. Cerebral embolic protection during Transcatheter aortic valve replacement. J Am Coll Cardiol. 2016. pii: S0735–1097(16)36768–7.  https://doi.org/10.1016/j.jacc.2016.10.023. [Epub ahead of print].
  46. 46.
    Bogren HG, Buonocore MH, Gu WZ. Carotid and vertebral artery blood flow in left- and right-handed healthy subjects measured with MR velocity mapping. J Magn Reson Imaging. 1994;4(1):37–42.CrossRefPubMedGoogle Scholar
  47. 47.
    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(1):51–6.CrossRefPubMedGoogle Scholar
  48. 48.
    Baumbach A, Mullen M, Brickman AM, Aggarwal SK, Pietras CG, Forrest JK, Hildick-Smith D, Meller SM, Gambone L, den Heijer P, Margolis P, Voros S, Lansky AJ. Safety and performance of a novel embolic deflection device in patients undergoing transcatheter aortic valve replacement: results from the DEFLECT I study. EuroIntervention. 2015;11(1):75–84.CrossRefPubMedGoogle Scholar
  49. 49.
    Nijhoff F, Doevendans PA, Stella PR, Agostoni P, Samim M, Van Der Worp B, Hendrikse J, Budde RP, Ramjankhan F. TriGuard™HD embolic deflection device for cerebral protection during transcatheter aortic valve replacement: the results of the DEFLECT II trial. EuroIntervention. 2015. Euro15A-MA052, published on May 15, 2015.Google Scholar
  50. 50.
    Lansky AJ, Schofer J, Tchetche D, Stella P, Pietras CG, Parise H, Abrams K, Forrest JK, Cleman M, Reinohl J, Cuisset T, Blackman D, Bolotin G, Spitzer S, Kappert U, Gilard M, Modine T, Hildick-Smith D, Haude M, Margolis P, Brickman AM, Voros S, Baumbach A. A prospective randomized evaluation of the TriGuard HDH embolic DEFLECTion device during transcatheter aortic valve implantation: results from the DEFLECT III trial. Eur Heart J. 2015;36(31):2070–8.CrossRefPubMedGoogle Scholar
  51. 51.
    Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the bleeding academic research consortium. Circulation. 2011;123(23):2736–47.CrossRefPubMedGoogle Scholar
  52. 52.
    Latib A, Naganuma T, Abdel-Wahab M, Danenberg H, Cota L, Barbanti M, Baumgartner H, Finkelstein A, Legrand V, de Lezo JS, Kefer J, Messika-Zeitoun D, Richardt G, Stabile E, Kaleschke G, Vahanian A, Laborde JC, Leon MB, Webb JG, Panoulas VF, Maisano F, Alfieri O, Colombo A. Treatment and clinical outcomes of transcatheter heart valve thrombosis. Circ Cardiovasc Interv. 2015;8(4). pii: e001779.Google Scholar
  53. 53.
    Leetmaa T, Hansson NC, Leipsic J, Jensen K, Poulsen SH, Andersen HR, Jensen JM, Webb J, Blanke P, Tang M, Norgaard BL. Early aortic transcatheter heart valve thrombosis: diagnostic value of contrast-enhanced multidetector computed tomography. Circ Cardiovasc Interv. 2015;8(4). pii: e001596.Google Scholar
  54. 54.
    Makkar RR, Fontana G, Sondergaard L. Possible subclinical leaflet thrombosis in bioprosthetic aortic valves. N Engl J Med. 2016;374(16):1591–2.PubMedGoogle Scholar
  55. 55.
    Pache G, Schoechlin S, Blanke P, Dorfs S, Jander N, Arepalli CD, Gick M, Buettner HJ, Leipsic J, Langer M, Neumann FJ, Ruile P. Early hypo-attenuated leaflet thickening in balloon-expandable transcatheter aortic heart valves. Eur Heart J. 2016;37(28):2263–71.CrossRefPubMedGoogle Scholar
  56. 56.
    Holmes DR Jr, Mack MJ, Kaul S, Agnihotri A, Alexander KP, Bailey SR, Calhoon JH, Carabello BA, Desai MY, Edwards FH, Francis GS, Gardner TJ, Kappetein AP, Linderbaum JA, Mukherjee C, Mukherjee D, Otto CM, Ruiz CE, Sacco RL, Smith D, Thomas JD. 2012 ACCF/AATS/SCAI/STS expert consensus document on transcatheter aortic valve replacement. J Am Coll Cardiol. 2012;59(13):1200–54.CrossRefPubMedGoogle Scholar
  57. 57.
    Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Guyton RA, O'Gara PT, Ruiz CE, Skubas NJ, Sorajja P, Sundt TM 3rd, Thomas JD. ACC/AHA task force members. 2014 AHA/ACC guideline for the Management of Patients with Valvular Heart Disease: executive summary: a report of the American College of Cardiology/American Heart Association task force on practice guidelines. Circulation. 2014;129(23):2440–92.CrossRefPubMedGoogle Scholar
  58. 58.
    Webb J, Rodés-Cabau J, Fremes S, Pibarot P, Ruel M, Ibrahim R, Welsh R, Feindel C, Lichtenstein S. Transcatheter aortic valve implantation: a Canadian cardiovascular society position statement. Can J Cardiol. 2012;28(5):520–8.CrossRefPubMedGoogle Scholar
  59. 59.
    Vahanian A, Alfieri O, Andreotti F, Antunes MJ, Barón-Esquivias G, Baumgartner H, Borger MA, Carrel TP, De Bonis M, Evangelista A, Falk V, Lung B, Lancellotti P, Pierard L, Price S, Schäfers HJ, Schuler G, Stepinska J, Swedberg K, Takkenberg J, Von Oppell UO, Windecker S, Zamorano JL, Zembala M, ESC Committee for Practice Guidelines (CPG), Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC), European Association for Cardio-Thoracic Surgery (EACTS). Guidelines on the Management of Valvular Heart Disease (version 2012): the joint task force on the management of Valvular heart disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur J Cardiothorac Surg. 2012;42(4):S1–44.CrossRefPubMedGoogle Scholar

Copyright information

© Springer International Publishing AG, part of Springer Nature 2018

Authors and Affiliations

  1. 1.Department of CardiologyThoraxcenter, Erasmus Medical CenterRotterdamThe Netherlands

Personalised recommendations