Cardiovascular News Issue 54—August 2019 US edition

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August 2019 | Issue 54 Francesco Maisano:

Transseptal puncture

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Partha Sardar and Herb Aronow:

Josep Rodés-Cabau:

Profile

Renal denervation

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PCR statement on TAVI signals Stakeholders a “paradigm shift” in the welcome updated treatment of aortic stenosis CMS coverage Evolving indications for the use of transcatheter aortic valve implantation (TAVI) have led to a series of “paradigm shifts” in the treatment of severe symptomatic aortic stenosis, according to a position statement issued by PCR, which says that TAVI should now be favoured over surgical aortic valve replacement (SAVR).

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nnouncing the statement at EuroPCR 2019 (20–24 May, Paris, France), Stephan Windecker (Bern University Hospital, Bern, Switzerland) said: “The favourable outcomes of TAVI are consistent across the entire risk spectrum, suggesting that surgical risk estimation is no longer the basis to guide the choice between TAVI and surgical aortic valve replacement.” Windecker explained: “The available evidence has been extended by two recent landmark trials in the low-risk patient population which provide us now with a comprehensive picture, ranging from extreme highrisk, intermediate-, to low-risk patients.” The aim of the PCR statement, he said, is to “synthesise the available evidence”. From this, three paradigm shifts can be identified. The first of these relates to the decision-making process between TAVI and SAVR: “Because the benefits are so consistent, the risk stratification that we applied using the STS [Society of Thoracic Surgery] score to identify patients at increased risk for surgery is no longer useful. Rather than categorise patients in the extreme, intermediate, and low risk, we should rather look at the clinical and anatomical characteristics of individual patients to guide the decision-making between these two procedures.” Secondly, the heart team will identify the best treatment option for individual patients, with transfemoral TAVI replacing SAVR as the default therapy for a greater number of patients: “Up to now, by default, in low-risk patients surgery was the therapy of choice, and TAVI was only to be considered in those patients where surgery would not be possible. In the nottoo-distant future, a scheme will emerge where actually the question will be reversed, with any patient being considered a priori to be a TAVI candidate and surgery being reserved to cases where that is not possible.” The third paradigm relates to prosthetic valve choice,

Stephan Windecker

and is to be based upon life expectancy and valve durability: “That should be, if we look at very young patients [<50 years], preferentially a mechanical valve prosthesis in case of aortic stenosis. In patients that are above 65 years of age, a bioprosthetic valve. The

In the not-too-distant future ... any patient will be considered a priori to be a TAVI candidate.” Continued on page 2

for TAVI

Stakeholders have welcomed an updated National Coverage Determination (NCD) from the US Centers for Medicare & Medicaid Services (CMS) on transcatheter aortic valve implantation (TAVI) in the treatment of symptomatic aortic valve stenosis, saying the decision will improve access to services. THE CMS ANNOUNCED in June that it will continue to cover the procedure through coverage with evidence development (CED) when furnished according to a US Food and Drug Administration (FDA)-approved indication. In addition, changes to the procedural volume requirements for hospitals and physicians to begin or maintain a TAVI programme allow greater flexibility for hospitals and providers to meet the criteria for performing TAVI. In a press release, Edwards Lifesciences said: “We believe the modernised requirements and more streamlined patient evaluation process are meaningful enhancements that may help ensure equitable access for more patients suffering from severe aortic stenosis. We are encouraged that CMS is open to moving towards a quality measure focused on patient outcomes, not procedural volume, in evaluating hospitals eligible to provide TAVR in the USA.” Medtronic also indicated its support in a statement, saying it “believes the new coverage policy allows for appropriate patient access to TAVI—especially for patients in rural communities—while still maintaining rigorous requirements for centres and operators providing the therapy.” Some physicians have given it a more mixed response. Satya Shreenivas (The Christ Hospital, Cincinnati, USA) pointed out: “It is vitally important Continued on page 2


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