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• W2048718364 abstract "Transcatheter aortic valve insertion vascular complications have been defined and redefined by the Valve Academic Research Consortium. We present a case that points out a paradox with the current definition of a minor vascular injury. A 92-year-old woman presented with severe aortic valve stenosis, diabetes, severe chronic lung disease, previous stroke, New York Heart Association functional class II dyspnea, hemoglobin 10.8 g/dL, and a Society of Thoracic Surgeons predicted risk of mortality of 16.417%. Left ventricular outflow tract measurements included an area of 454 mm2 and a perimeter of 78.5 mm. The iliac and femoral arteries all measured >8 mm in diameter and were without calcification. The patient underwent transfemoral transcatheter aortic valve insertion through an open right external iliac artery access. Some resistance was noted during sheath insertion. Valve deployment went without apparent difficulty. The sheath did not slide out easily, but required some backward tension. Subsequent inspection of the sheath demonstrated that it contained a near perfect specimen of the external iliac artery (Figure 1, Figure 2).Figure 2Close-up view of external iliac artery avulsion on sheath. The specimen represents the entire external iliac artery.View Large Image Figure ViewerDownload Hi-res image Download (PPT) Upon identification of the vascular injury, the dilator and sheath were immediately reinserted over the wire, which had been maintained. There was no active bleeding. A right lower quadrant incision and retroperitoneal exposure were performed to expose the iliac artery. Despite the injury, there was no retroperitoneal hematoma. Vascular control was obtained, and a Dacron interposition graft was placed. During all of this, the patient's electrocardiogram and hemodynamic characteristics remained entirely stable; furthermore, she required no inotropic support or blood transfusion. Three days later the patient was ambulating without difficulty with a hemoglobin level of 9.2 g/dL. She was discharged to a skilled nursing facility. At her 1-month follow-up, she was classified as New York Heart Association functional class II. The Valve Academic Research Consortium-2 (VARC-2) consensus document defines a major vascular injury as “leading to death, life-threatening or major bleeding, visceral ischemia, or neurological impairment.”1Kappetein A.P. Head S.J. Genereux P. Piazza N. van Mieghem N.M. Blackstone E.H. et al.Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document.J Thorac Cardiovasc Surg. 2013; 145: 6-23Abstract Full Text Full Text PDF PubMed Scopus (710) Google Scholar None of these events occurred in this patient. Is this, therefore, a minor vascular injury as defined by VARC-2 criteria? Had this unplanned vascular procedure occurred during the pivotal transcatheter aortic valve insertion studies done under the auspices of the first VARC consensus document, this case would have been classified as a major vascular injury.2Leon M.B. Piazza N. Nikolsky E. Blackstone E.H. Cutlip D.E. Kappetein A.P. et al.Standardized endpoint definitions for transcatheter aortic valve implantation clinical trials: a consensus report from the valve academic research consortium.J Am Coll Cardiol. 2011; 57: 253-269Abstract Full Text Full Text PDF PubMed Scopus (696) Google Scholar, 3Smith C.R. Leon M.B. Mack M.J. Miller D.C. Moses J.W. Svensson L.G. et al.Transcatheter versus surgical aortic-valve replacement in high-risk patients.N Engl J Med. 2011; 364: 2187-2198Crossref PubMed Scopus (4797) Google Scholar, 4Adams D.H. Poma J.J. Reardon M.J. Yakubov S.J. Coselli J.S. Deeb G.M. et al.Transcatheter aortic-valve replacement with a self-expanding prosthesis.N Engl J Med. 2014; 370: 1790-1798Crossref PubMed Scopus (2038) Google Scholar It is obvious that this case represents a major vascular injury related to transfemoral transcatheter aortic valve insertion. Newly planned studies may elect to use the updated VARC-2 criteria, and this may lead to confusion in grading of clinically significant vascular injuries. It is our opinion that vascular complications, much like death and pregnancy, are best classified with a dichotomous variable; that is, yes or no, rather than using mitigating qualifiers such as major, minor, or presence of percutaneous closure device failure." @default.
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• W2048718364 date "2015-03-01" @default.
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• W2048718364 title "Consortium-defined vascular complications: You say minor, I say major" @default.
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• W2048718364 doi "https://doi.org/10.1016/j.jtcvs.2014.10.073" @default.
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