News of two large clinical trials that suggest transcatheter aortic valve replacement (TAVR) could benefit a wider group of patients with severe aortic stenosis brought attention last week to Boulder Community Health’s Structural Heart program and director Dr. Srinivas Iyengar, who was quoted in a March 16 article in the Wall Street Journal. The New York Times also published a positive article that day, stating that research showed TAVR "proved effective in younger, healthier patients."

To read the full text of the WSJ article, scroll down or click here (subscription required).
To read the full text of the NYT article, click here.

BCH's Boulder Heart is the only program in Boulder County performing TAVR, an innovative, minimally invasive procedure to replace failing aortic valves. Dr. Iyengar leads the most experienced team in Colorado -- with over 1,000 TAVR procedures performed by himself and Dr. Daniel O'Hair

dr-srinivas-iyengar-could-community-health"Boulder Community Health has established itself as leader in the community not only by investing in TAVR technology but also in the skill and experience needed to deliver the leading-edge care that our community deserves," says Jeffrey Reed, executive director of Specialty Services at BCH. "Dr. Iyengar brings hundreds of cases under his belt -- not just TAVR, but also minimally invasive procedures like Watchman, Mitraclip and PFO closures. In addition, with our world-class cardiothoracic surgery team headed by Dr. Daniel O'Hair and Dr. Bryan Mahan, BCH is poised to take cardiology care to the next level and beyond."

Since the FDA first approved TAVR in 2011, it has been reserved mostly for patients whose age or physical condition disqualify them from having open heart surgery. Access to TAVR also has been generally limited to larger hospitals that perform more procedures each year, due to rules and reimbursement policies set by Medicare, the federal health insurance program for the elderly.

In the WSJ article, Dr. Iyengar said about this issue: “I feel the ivory tower mentality of a lot of major medical centers is to say, ‘We would like this procedure done only in our hospital.' That doesn’t serve the patient’s best interest.”

The two new clinical trials bolster the current debate swirling around the standard of care for most patients with failing aortic valves, since the data shows TAVR is just as effective in younger, healthier patients. On average, the study subjects were in their low to mid-seventies, about a decade younger than current patients.

Cardiovascular surgeons know that valves placed by open-heart surgery tend to last 10 to 15 years. How long TAVR valves will last remains to be determined as the patient data grows. The Centers for Medicare and Medicaid Services is expected to propose new rules by the end of this month that would govern which doctors and hospitals can offer TAVR.

Call our Structural Heart coordinator to schedule an assessment with Dr. Iyengar: 303-415-8898.

Hear how TAVR changed these BCH patients' lives

Read on for the full text of both articles:

Tens of Thousands of Heart Patients May Not Need Open-Heart Surgery
Replacement of the aortic valve with a minimally invasive procedure called TAVR proved effective in younger, healthier patients.
by Gina Kolata, The New York Times (March 16, 2019)

The operation is a daring one: To replace a failing heart valve, cardiologists insert a replacement through a patient’s groin and thread it all the way to the heart, maneuvering it into the site of the old valve.

The procedure, called transcatheter aortic valve replacement (TAVR), has been reserved mostly for patients so old and sick they might not survive open-heart surgery. Now, two large clinical trials show that TAVR is just as useful in younger, healthier patients.

It might even be better, offering lower risks of disabling strokes and death, compared to open-heart surgery. Cardiologists say it will likely change the standard of care for most patients with failing aortic valves.

“Is it important? Heck, yes,” said Dr. Robert Lederman, who directs the interventional cardiology research program at the National Heart, Lung and Blood Institute. The findings “were remarkable,” he added.

Dr. Lederman was not involved with the studies and does not consult for the two device companies that sponsored them.

In open-heart surgery, a patient’s ribs are cracked apart and the heart is stopped to insert the new aortic valve.

With TAVR, the only incision is a small hole in the groin where the catheter is inserted. Most patients are sedated, but awake through the procedure, and recovery takes just days, not months, as is often the case following the usual surgery.

The results “shift our thinking from asking who should get TAVR to why should anyone get surgery,” said Dr. Howard Herrmann, director of interventional cardiology at the University of Pennsylvania.

“If I were a patient, I would choose TAVR,” said Dr. Gilbert Tang, a heart surgeon at the Icahn School of Medicine at Mount Sinai in New York, who was not involved in the new research.

The studies are to be published in the New England Journal of Medicine and presented on Sunday at the American College of Cardiology’s annual meeting.

The Food and Drug Administration is expected to approve the procedure for lower-risk patients. As many as 20,000 patients a year would be eligible for TAVR, in addition to the nearly 60,000 intermediate- and high-risk patients who get the operation now.

“This is a clear win for TAVR,” said Dr. Michael J. Mack, a heart surgeon at Baylor Scott and White The Heart Hospital-Plano, in Texas. From now on, “we will be very selective” about who gets open-heart surgery, said Dr. Mack, a principal investigator in one of the trials.

Some healthier patients will still need the traditional surgery — for example, those born with two flaps to the aortic valve instead of the usual three. Having two flaps can lead to early aortic valve failure.

TAVR was not tested in these patients, and the condition occurs more often in younger patients who are low surgical risks.

Aortic valve failure stems from a stiffening of the valve controlling flow from the large vessel in the heart that supplies blood to the rest of the body. Patients often are tired and short of breath.

There is no way to prevent the condition, and no treatment other than replacing the valve. The main risk factor is advancing age.

Although both studies enrolled over 1,000 patients, the trials differed slightly in design, making direct comparisons difficult.

The study led by Dr. Mack and Dr. Martin Leon, an interventional cardiologist at Columbia University in New York, tracked deaths, disabling strokes and hospitalizations at one year following the procedures. The rates were 15 percent with surgery versus 8.5 percent with TAVR.

The rates of deaths and disabling strokes — the factors most important to patients — were 2.9 percent with surgery versus 1 percent with TAVR.

The second study estimated deaths or disabling strokes at two years, finding rates of 6.7 percent with surgery versus 5.3 percent with TAVR.

The trials were sponsored by makers of TAVR valves, Edwards Lifesciences of Irvine, Calif., and Medtronic, headquartered in Dublin. The two companies make slightly different valves.

The Edwards valve is compressed onto a balloon catheter that is pushed through a blood vessel from the groin to the aorta. Once it reaches the aorta, a cardiologist inflates the balloon and expands the valve, which pushes aside the failing valve.

The Medtronic valve is made of nitinol, a metal that shrinks when it is cold and expands when warm. The valve is chilled and put onto a catheter. When it reaches the aorta, the cardiologist pulls back a sheath, freeing the new valve. Warmed by the body, it expands to fill the narrowed opening and remains there.

With traditional surgery, by contrast, a doctor cuts out the old valve and sews in a new one, removing the old valve instead of leaving it in the heart.

Dr. Jeffrey J. Popma, an interventional cardiologist at Beth Israel Deaconess in Boston, led the second trial and is a consultant for both manufacturers. He uses both devices in surgery, and said the important finding is that both [devices] were preferable to surgery.

The studies involved leading surgeons and cardiologists at academic medical centers, many enlisted as consultants. Independent data and safety monitoring committees oversaw the trials, and independent statisticians confirmed the results.

Aortic valve replacements have been performed for decades, and surgeons know the valves placed during surgery last at least 10 to 15 years. It remains to be seen if TAVR valves will fare as well.

The question is especially important for younger patients. The average age of subjects in the current studies was the low to mid 70s, younger by a decade or more than most patients getting TAVR now.

Hospitals offering TAVR will take a financial hit when lower-risk patients start opting for it, Dr. Herrmann said. The TAVR valves cost far more than valves placed surgically, but insurers usually pay equally for either procedure.

“Open-heart surgery, particularly in low-risk patients, is very profitable,” Dr. Herrmann said.

More than half a dozen companies make surgical valves, but only two market TAVR valves. Perhaps with more competition, Dr. Herrmann said, prices for TAVR valves will come down.

At the moment, it will be up to most patients which procedure they choose, Dr. Popma said — TAVR or surgery.

For Robert Pettinato, 79-year-old retiree in Scranton, Pa., there was no question. He had been feeling mild chest pain, and he was finding it difficult to finish a round of golf.

But last year, when his cardiologist told Mr. Pettinato that he needed a new valve, the only way he could get TAVR was to enter a clinical trial. He enrolled in the Edwards trial at the University of Pennsylvania.

He had TAVR in November, stayed in the hospital for 24 hours and went home. A few days later, he went to the football game at Lehigh University against its archrival, Lafayette. (He’s a Lehigh alumnus and never misses that game.)

Shortly afterward, his younger brother Jim, who lives in Florida, had to have aortic valve replacement. He wanted TAVR, but the clinical trials were closed. He had surgery instead.

It took his brother four months to recover enough to play a round of golf, Mr. Pettinato said.

Mr. Pettinato is back to playing golf himself. “I am the luckiest guy in the world,” he said.

Smaller Hospitals Press for Chance to Offer Heart-Valve Procedure
Safety vs. accessibility is at center of debate as Medicare agency is poised to propose new rules
by Peter Loftis, Wall Street Journal (March 16, 2019)

A bat­tle has bro­ken out among doc­tors, hos­pi­tals and med­ical-de­vice mak­ers over whether an in­creas­ingly pop­u­lar but risky med­ical pro­ce­dure for re­plac­ing de­fec­tive heart valves should be of­fered more widely.

The fight is over which hos­pitals can get paid by the fed­eral gov­ern­ment to per­form the pro­ce­dure, of­ten re­ferred to as TAVR, for tran­scatheter aor­tic valve re­place­ment. Cur­rently, big­ger hos­pi­tals that per­form the pro­ce­dures more fre­quently are fa­vored un­der fed­eral re­im­burse­ment poli­cies—based on stud­ies link­ing vol­ume to qual­ity—while smaller hos­pitals have a tougher time meet­ing the rules to start or main­tain TAVR of­fer­ings.

TAVR has trans­formed treatment of cer­tain heart-dis­ease pa­tients by giv­ing them an al­ter­na­tive to open-heart surgery. Many of these pa­tients are too sick to un­dergo the risks of open-heart surgery; yet pa­tients un­der­go­ing TAVR also are at risk of com­pli­ca­tions, in­clud­ing stroke.

To en­sure safety, TAVR’s use has been ef­fec­tively lim­ited to big­ger hos­pi­tals per­form­ing at least 20 of the pro­ce­dures an­nu­ally. That is be­cause the fed­eral Medicare health in­sur­ance pro­gram for the el­derly, the big­gest payer of TAVR bills in the U.S., has lim­ited re­im­burse­ment to hos­pi­tals that would per­form higher vol­umes of the pro­cedures.

The Cen­ters for Medicare and Med­icaid Ser­vices is ex­pected to pro­pose new rules by the end of this month that would gov­ern which doc­tors and hos­pi­tals can of­fer it. Some doc­tors, es­pecially those in rural lo­ca­tions where it can be harder to find a hos­pi­tal per­form­ing TAVR, have ar­gued that ad­vance­ments in the pro­ce­dure have made it less risky.

The de­ci­sion could af­fect rev­enue of the com­pa­nies that sell the re­place­ment heart valves. Ed­wards Life­sciences, the mar­ket leader, sold $2.2 bil­lion in the valves world-wide last year, while Medtronic PLC sold about $1.4 bil­lion, ac­cording to Jef­feries LLC an­a­lyst Raj Den­hoy.

Medicare’s move also could af­fect pa­tients. Two new clin­i­cal stud­ies pub­lished on­line Sat­ur­day by the New Eng­land Jour­nal of Med­i­cine sug­gest TAVR could ben­e­fit a wider group of pa­tients, in­clud­ing those deemed healthy enough to with­stand open-heart surgery. Re­searchers are slated to present the re­sults Sun­day at the Amer­i­can Col­lege of Car­di­ol­o­gy’s an­nual meet­ing in New Or­leans.

One study, funded by Ed­wards, showed TAVR re­duced rates of death, stroke and re-hos­pi­tal­ization ver­sus surgery. A Medtronic study found TAVR was com­pa­ra­ble to surgery in rates of death and dis­abling stroke.

Yet a study pub­lished in JAMA Car­di­ol­ogy in 2017 found there was a lower rate of read­mis­sion of pa­tients 30 days af­ter TAVR pro­ce­dures per­formed at high-vol­ume hos­pi­tals, 15.6%, than at lower-vol­ume sites, where rates were 19% to 19.5%. Pa­tients were read­mit­ted for heart com­pli­ca­tions and in­fec­tions, among other causes.

TAVR is for pa­tients with a con­di­tion called aor­tic steno­sis, caused by a nar­row­ing of the heart valve that can lead to heart fail­ure and death. The pro­ce­dure con­sists of thread­ing a catheter through a pa­tient’s artery and then re­plac­ing the de­fec­tive heart valve.

Nearly 200,000 pa­tients in the U.S. have un­der­gone TAVR since it be­came avail­able in 2011, in­clud­ing more than 50,000 in the first nine months of last year, ac­cord­ing to the So­ci­ety of Tho­racic Sur­geons, which man­ages the reg­istry of TAVR pro­ce­dures. The pro­ce­dures can cost be­tween $50,000 and $60,000 a pa­tient, in­clud­ing hos­pi­tal ad­mis­sion costs.

Medicare’s re­im­burse­ment re­stric­tion lim­ited TAVR to about 600 hos­pi­tals in the U.S., a lit­tle more than half the num­ber that pro­vide heart surgery. That has forced pa­tients in some rural ar­eas to travel far to get the pro­ce­dure, and led their doc­tors and hos­pi­tals to lobby for ex­panded use.

Wyoming has no TAVR cen­ters, forc­ing pa­tients there to drive sev­eral hours to hos­pi­tals in Col­orado or else­where, said Dr. Adrian Flu­ture, a car­di­ol­o­gist in Casper. His prac­tice sends about 30 pa­tients a year out of state be­cause the Wyoming Med­ical Cen­ter in Casper doesn’t have the vol­ume of heart pa­tients to meet the Medicare thresh­olds.

“Our con­cern is we’re not of­fer­ing the right treat­ment for the Wyoming pop­u­la­tion,” Dr. Flu­ture said.

Dr. Flu­ture and other doc­tors af­fil­i­ated with smaller hos­pi­tals say CMS should ei­ther elim­i­nate vol­ume re­quire­ments or make them less re­stric­tive. They say TAVR has be­come a less com­plicated pro­ce­dure since it first came out, and there are ex­ist­ing tools to mon­i­tor the safety of pro­ce­dures, in­clud­ing a national reg­istry of the out­comes of TAVR pro­ce­dures.

But doc­tors at larger hos­pi­tals and aca­d­e­mic med­ical cen­ters say pa­tient safety calls for re­strict­ing TAVR to those who can do the pro­ce­dure frequently.

“The more you do, the bet­ter you get at it,” said Dr. Joseph Bavaria, pro­fes­sor of surgery at the Uni­ver­sity of Penn­syl­va­nia’s Perel­man School of Med­i­cine in Phil­adelphia, and co-au­thor of the heart so­ci­eties’ rec­om­menda­tions. “Some of these com­plicated things shouldn’t be done at su­per-small hos­pi­tals.” He says Penn’s hos­pi­tal sys­tem per­forms be­tween 400 and 500 TAVR pro­ce­dures a year.

“I feel the ivory tower men­tal­ity of a lot of ma­jor med­ical cen­ters is to say, ‘We would like this pro­ce­dure done only in our hos­pi­tal,’” said Dr. Srini­vas Iyen­gar, who helped start a TAVR pro­gram at Boul­der Com­mu­nity Health hos­pi­tal in Boul­der, Colo., in 2017. “That doesn’t serve the pa­tient’s best in­ter­est.”

The four ma­jor or­ga­ni­za­tions rep­re­sent­ing heart doc­tors, in­clud­ing the Amer­i­can Col­lege of Car­di­ol­ogy, say there is a cor­re­la­tion be­tween vol­ume and qual­ity of TAVR pro­ce­dures. In a joint pro­posal to Medicare, the groups rec­om­mended rais­ing the vol­ume re­quirements to hos­pi­tals per­form­ing at least 50 a year or 100 over two years, up from 20 a year or 40 over two years.

Dr. Allen Baum, pres­i­dent of Car­di­ol­ogy Clinic of San An­to­nio and sup­porter of the vol­ume requirements, said in a let­ter to CMS last year “there are some very pow­er­ful lob­bying forces that will want to lib­er­al­ize these cri­te­ria be­cause of the fi­nan­cial ben­e­fit to their in­sti­tu­tion. The de­vice in­dus­try wants to sell more de­vices, every small hos­pi­tal CEO would love to have this done at their hos­pi­tal.”

Ed­wards Life­sciences, which ini­tially was se­lec­tive about which hos­pi­tals and doc­tors could use its valves, now fa­vors drop­ping the vol­ume re­quirements and al­low­ing lower-vol­ume hos­pi­tals to of­fer the pro­ce­dure, say­ing it has be­come safer and more rou­tine.

“We’re at a point in time where re­sults have im­proved dra­mat­ically,” Larry Wood, Ed­wards’ cor­po­rate vice pres­i­dent of tran­scatheter heart valves, said in an in­ter­view.

Medtronic fa­vors main­tain­ing cur­rent vol­ume re­quire­ments un­til bet­ter ev­i­dence emerges that they should be ad­justed. The com­pany said in a let­ter to CMS last year the ev­i­dence of a cor­re­la­tion be­tween vol­ume and qual­ity is mixed.

Call our Structural Heart coordinator to schedule an assessment with Dr. Iyengar: 303-415-8898