Review of TAVR Use Offers Significant Advances, Positive Outcomes

MIAMI BEACH, FLA.—The future of transcatheter aortic valve replacement (TAVR) will be driven by improved procedural technique and post-procedure patient management, along with product innovations and expansion into new patient populations, according to a presenter at TCT 2012.

During the Valvular Heart Disease Summit, Eberhard Grube, MD, from the University Bonn, Bonn, Germany, said overall TAVR outcomes remain positive.

“[Outcomes] are superior compared with medical management in extreme risk/inoperable patients, and non-inferior compared with surgery in high-risk patients,” Grube said. “Recent data have shown excellent 6-month survival rates in the CoreValve ADVANCE study in a large patient cohort” (see Figure).

Review of TAVR

Grube said TAVR transfemoral and transapical systems under development also offer promising results. Two new Edwards valve platforms, balloon expandable and self expanding, will begin trials soon, according to Grube. As for procedural advancements in 2012, Grube said these would be focused primarily on imaging and sizing, with new access routes also emerging.

Regarding the role of balloon aortic valve therapy, Grube said there are several disadvantages, including rapid pacing with hemodynamic deterioration, balloon/annular rupture, and aortic regurgitation, among others. In fact, 2% to 16% of new pacemaker implantations in TAVR may result from conduction disturbances caused during balloon aortic valve dilatation, he said.

New studies of TAVR without balloon therapy are showing promise, Grube added, which is particularly positive for patients at high risk for stroke or with low cardiac output.

In the area of vascular complications and delivery profile, there have been delivery system advancements: “We are trying to create fewer large holes and we are adapting with sheath sizes, and large vessel closure landscape is coming,” Grube said.

He noted that embolic material release during procedures is also being addressed through alternative access routes, embolic protection devices, and anti-coagulation management.

“Stroke is a major concern,” Grube said.

Clinical outcomes and complications

TCT Course Director Martin B. Leon, MD, of Columbia University Medical Center in New York, provided a status update on TAVR, which received FDA approval last November, as well as the recent approval of high surgical risk indications for the transcatheter Sapien heart valve, Leon said.

“[These options] will allow us to treat these high-risk patients,” Leon said.

He added that there will be dramatic continued growth in TAVR, with regard to the number of cases and clinical research, with a major indication being high-risk aortic stenosis. That being said, TAVR is a somewhat less predictable procedure than surgery and is associated with several complications.

“Future efforts should be directed at reducing these complications,” Leon said.

Clinical research issues that remain unresolved, according to Leon, include frailty and so-called ‘futility’ patients for whom there is uncertainty as to whether the procedure would make much of a difference. Other issues of importance include a dedicated TAVR risk score, preferred access, (transfemoral vs. transapical vs. transaortic), procedural details (annulus sizing, RV pacing, etc), adjunctive pharmacotherapy (peri- and post-TAVR), differences among existing and new transcatheter heart valve systems, value of accessory devices and durability.

In conclusion, Leon said that while new TAVR clinical indications are exciting, all require careful clinical evaluations, which typically include randomized controlled trials. There also are important training considerations, but economic constraints limit TAVR penetration, he stressed.

Disclosures
  • Dr. Grube reports receiving financial support and speaking fees from numerous companies.
  • Dr. Leon reports that he has received grant support, consulting fees and is a major stockholder with/from numerous device companies.

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