European valvular heart disease guideline parses who should get TAVR or surgical AVR
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The new European Society of Cardiology/European Association for Cardio-Thoracic Surgery valvular heart disease guideline includes updated recommendations on which patients should get transcatheter or surgical aortic valve replacement.
“Surgical aortic valve replacement and transcatheter aortic valve implantation are both excellent treatment options for aortic stenosis,” Bernard D. Prendergast, BMedSci, BM, BS, MD, FRCP, FESC, professor of interventional cardiology and valvular heart disease at St. Thomas Hospital, London, and chair of cardiology at Cleveland Clinic London, said during a presentation at the European Society of Cardiology Congress. “The choice between the mode of intervention must be based upon a heart team evaluation of all patients. In straightforward presentations, surgery is recommended for younger patients at low surgical risk and for patients where transfemoral TAVI is not possible and the patient remains operable. TAVI is preferred in older patients of 75 years or greater and in those of inoperable or high surgical risk.”
He said the guidelines state TAVR is favored for patients with the following characteristics: high surgical risk, older age, previous cardiac surgery (particularly CABG), severe frailty, feasibility via the transfemoral approach, when the transfemoral approach is difficult or impossible but surgery is not feasible, past chest radiation, porcelain aorta, high likelihood of severe patient/prosthesis mismatch and severe chest deformation or scoliosis.
He added the guidelines state surgical AVR is favored for patients with the following characteristics: lower surgical risk, younger age, endocarditis, when the transfemoral approach is difficult or impossible but surgery is feasible, aortic annular dimensions unsuitable for TAVR systems, bicuspid aortic valves, valve morphology unfavorable for TAVR and thrombus in the aorta or left ventricle.
‘The elephant in the room’
During a discussion after the presentation, Roxana Mehran, MD, FACC, FACP, FCCP, FESC, FAHA, FSCAI, professor of medicine and director of Interventional Cardiovascular Research and Clinical Trials at the Zena and Michael A. Wiener Cardiovascular Institute Icahn School of Medicine at Mount Sinai, questioned why TAVR was recommended in patients 75 years and older, but not younger.
“The elephant in the room here is that in your guidelines, which are fantastic, you’re preferring surgery to TAVR in patients under the age of 75,” Mehran said. “I have a patient [who is] 68 years-old with severe aortic stenosis who does not want to hear about an open-heart procedure when an alternative exists in TAVR and he is a good candidate for the transfemoral approach. How do I answer that patient’s questions?”
Friedhelm Beyersdorf, MD, professor of surgery at University Heart Center Freiburg, Germany, and EACTS chairperson of the guideline task force, said the trials of TAVR in patients at low surgical risk do not yet have data for more than 2 years and did not have age-based inclusion criteria.
“The rules for guidelines are such that we can change something if there is scientific evidence for a change,” Beyersdorf said. “In the older guidelines from 2017, 75 years is written. There was no scientific basis to change it, and therefore we left it.”
COAPT data incorporated
The guidelines also updated recommendations on intervention in patients with severe secondary mitral regurgitation, based on data from the COAPT and MITRA-FR trials.
Fabien Praz, MD, interventional cardiologist at Bern University Hospital, Switzerland, said the guidelines recommend that mitral valve surgery or transcatheter intervention in this population should only be performed in patients who remain symptomatic despite guideline-recommended medical therapy and who are recommended for a procedure by a heart team. In those who are not candidates for surgery, PCI or TAVR possibly followed by transcatheter edge-to-edge repair if symptoms remain should be considered.
The results of COAPT and MITRA-FR differed because their inclusion criteria differed, so the guidelines recommend that transcatheter edge-to-edge repair be performed preferably if a patient meets criteria suggesting they have a good chance of responding to it, while other selected patients may draw symptomatic benefit from the therapy, Praz said.
“There is a need, which is nicely reflected in the guidelines, for a multidisciplinary approach in patients with secondary mitral regurgitation, and the recommendation for transcatheter edge-to-edge repair in patients fulfilling criteria suggesting increased chance of responding to the therapy according to COAPT has been upgraded, while other selected patients may also derive a symptomatic benefit from the intervention.”