Transcatheter Aortic Valve Replacement

Table 1. Current Treatment Recommendations for Patients with Aortic Stenosis Table 1. Current Treatment Recommendations for Patients with Aortic Stenosis (continued) Treatment Indication Major Complications Treatment Indication Surgical Aortic Valve Replacement ������ Symptomatic severe AS (I-B) ������ Severe AS undergoing CABG, aortic surgery or other valve surgery (I-C) ������ Symptomatic moderate AS undergoing CABG, aortic surgery or other valve surgery (IIa-C) ������ Asymptomatic severe AS with hypotensive response to exercise (IIb-C) ������ Asymptomatic extremely severe AS (AVA < 0.6 cm2, mean gradient > 50 mm Hg, or jet velocity > 5 m/s) (IIb-C) ������ Mortality (3%) ������ Stroke (2%) ������ Prolonged ventilation (11%) ������ Thromboembolism and bleeding ������ Prosthetic dysfunction ������ Perioperative complications are higher when surgical AVR is combined with CABG Medical Therapy ������ There is no specific therapy for ������ Hemodynamic instability asymptomatic AS ������ Medical therapy is not indicated for symptomatic severe AS ������ Appropriate control of blood pressure and other risk factors as indicated ������ Statins are NOT indicated for preventing progression of AS ������ Diuretics, vasodilators and positive inotropes should be avoided in patients awaiting surgery because of risk of destabilization Transcatheter Aortic Valve Replacement ������ TAVR is recommended in patients with severe, symptomatic, calcific stenosis of a tricuspid aortic valve who have aortic and vascular anatomy suitable for TAVR and a predicted survival >12 months, and who have a prohibitive surgical risk as defined by an estimated 50% or greater risk of mortality or irreversible morbidity at 30 days or other factors such as frailty, prior radiation therapy, porcelain aorta, and severe hepatic or pulmonary disease. ������ TAVR is a reasonable alternative to surgical AVR in patients at high surgical risk (PARTNER Trial Criteria: STS ���8%a) ������ Mortality (3%-5%) ������ Stroke (6%-7%) ������ Access complications (17%) ������ Pacemaker insertion ������ 2%-9% (Sapien) ������ 19%-43% (CoreValveb) ������ Bleeding ������ Prosthetic dysfunction ������ Paravalvular AR ������ Acute kidney injury ������ Other ������ Coronary occlusion ������ Valve embolization ������ Aortic rupture ������ Reasonable for palliation in adult patients with AS in whom surgical AVR cannot be performed because of serious comorbid conditions (IIb-C) ������ Bridge to surgical AVR (if patient is poor surgical candidate) (IIb-C) ������ Mortality ������ Stroke ������ Access complications ������ Restenosis Balloon Aortic Valvuloplasty Major Complications The original PARTNER protocol specified inclusion criteria as a minimum STS-predicted risk of mortality of ���10. During the trial enrollment phase, the minimum STS-predicted risk of mortality was changed to ���8. In both instances, 2 surgeons had to document that the true predicted risk of mortality was ��� 15. b CoreValve is investigational only. a Evidence Grades Class I: Conditions for which there is evidence for and/or general agreement that the procedure or treatment is beneficial, useful, and effective Class II: Conditions for which there is conflicting evidence and/or a divergence of opinion about the usefulness/efficacy of a procedure or treatment Class IIa: Weight of evidence/opinion is in favor of usefulness/efficacy Class IIb: Usefulness/efficacy is less well established by evidence/opinion Level of Evidence A: Data derived from multiple randomized clinical trials or meta-analyses Level of Evidence B: Data derived from a single randomized trial or nonrandomized studies Level of Evidence C: Only consensus opinion of experts, case studies, or standard-of-care.

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