Non­sur­gi­cal heart valve pro­ce­dure spurs cost con­cerns

Modern Healthcare - - NEWS - By Steven Ross John­son

Re­sults from the lat­est trial com­par­ing non­sur­gi­cal im­plan­ta­tion of a pros­thetic tran­scatheter aor­tic valve re­place­ment, or TAVR, with tra­di­tional sur­gi­cal aor­tic valve re­place­ment have raised the pos­si­bil­ity that the new method could be used for a broader range of pa­tients.

But shift­ing to wider TAVR de­vice use could hurt hos­pi­tals fi­nan­cially be­cause of their high cost.

At the Amer­i­can Col­lege of Car­di­ol­ogy’s an­nual sci­en­tific ses­sion in Wash­ing­ton, med­i­cal de­vice­maker Medtronic re­ported re­sults from the high-risk pa­tient group in­cluded in the U.S. Piv­otal trial of its CoreValve TAVR de­vice. Ses­sion co-chair Dr. Pred­i­man Shah, di­rec­tor of the Ath­er­o­scle­ro­sis Preven­tion and Treat­ment Cen­ter at Los Angeles’ Cedars-Si­nai Med­i­cal Cen­ter, said in a March 18 tele­brief­ing that TAVR would some­day re­place surgery as the pre­ferred method for aor­tic valve re­place­ment.

“It’s go­ing to be very hard to tell a pa­tient, if they need an aor­tic valve, that surgery is their best op­tion,” he said in a March 19 re­port in Car­di­ol­ogy News.

Some ex­perts say the lat­est re­sults could pro­mote ex­panded TAVR use among high-risk pa­tients for whom surgery is an op­tion. But oth­ers say the price of TAVR de­vices may de­ter providers if they can achieve the same or bet­ter re­sults through surgery for that pa­tient sub­group.

TAVR de­vices typ­i­cally cost about $32,000, com­pared with sur­gi­cal valves that aver­age be­tween $4,000 and $7,000, said Dr. Lars Svens­son, di­rec­tor of qual­ity and process im­prove­ment in the Cleve­land Clinic’s depart­ment of tho­racic and car­dio­vas­cu­lar surgery.

Some hos­pi­tals in high-cost ar­eas such as New York can re­ceive Medi­care re­im­burse­ment for per­form­ing TAVR pro­ce­dures as high as $92,000. But in other ar­eas such as Cleve­land, re­im­burse­ment for TAVR is lower, mak­ing it a los­ing propo­si­tion. “For in­sti­tu­tions in the mid­dle of the coun­try, they typ­i­cally get paid less than it costs to do the pro­ce­dure,” Svens­son said. “It varies, but most of the (TAVR) pro­grams are just break­ing even.”

Valve re­place­ment is rec­om­mended for se­vere cases of aor­tic steno­sis, a nar­row­ing of the heart’s aor­tic valve that af­fects more than 1 mil­lion Amer­i­cans, most of them el­derly. About 290,000 pa­tients are el­i­gi­ble for TAVR, ac­cord­ing to a 2013 study in the Jour­nal of the Amer­i­can Col­lege of Car­di­ol­ogy, with 27,000 more be­com­ing el­i­gi­ble for the pro­ce­dure each year.

The TAVR tech­nique, which the Food and Drug Ad­min­is­tra­tion first ap­proved in 2011 for use in pa­tients not el­i­gi­ble for surgery, in­volves in­sert­ing a pros­thetic valve with a catheter threaded through an artery in the groin or rib cage. The method typ­i­cally re­quires a shorter re­cov­ery time than open-heart surgery. In 2012, it was ap­proved for use in high­risk surgery pa­tients.

Medtronic’s CoreValve be­came the sec­ond pros­the­sis ap­proved for use in the U.S. in Jan­uary. The first, the SAPIEN tran­scatheter heart valve, cre­ated by Ed­ward Life­sciences Corp., was ap­proved in 2011.

The re­ported re­sults were promis­ing in CoreValve tri­als treat­ing pa­tients who faced “ex­treme risk” in un­der­go­ing surgery. The rate of all-cause mor­tal­ity or ma­jor stroke af­ter one year was 25%, be­low the trial goal of 43%. Rates of de­vel­op­ing a ma­jor stroke were 2.4% af­ter 30 days and 4.1% af­ter one year, which led to FDA ap­proval.

But TAVR did not fare as well as the sur­gi­cal op­tion when com­pared with stroke risk. In a re­view of more than 7,000 pro­ce­dures pub­lished in a 2013 study in the Jour­nal of Amer­i­can Med­i­cal As­so­ci­a­tion, TAVR pa­tients de­vel­oped stroke at more than dou­ble the rate of those who had open-heart surgery.

For many pa­tients deemed too sick or frail for open-heart surgery, how­ever, the in­tro­duc­tion of TAVR of­fers new hope. “TAVR is tremen­dous,” said Dr. Tor­rey Si­mons, a fel­low at Stan­ford Univer­sity’s health ser­vices re­search and de­vel­op­ment pro­gram.

“It’s go­ing to be very hard to tell a pa­tient, if they need an aor­tic valve, that surgery is their best op­tion.” —Dr. Pred­i­man Shah, di­rec­tor of the Ath­er­o­scle­ro­sis Preven­tion and Treat­ment Cen­ter at Cedars-Si­nai Med­i­cal Cen­ter in Los Angeles

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