The lat­est sur­gi­cal fix for bro­ken hearts.

Tom Black­well on the new pro­ce­dure re­plac­ing ‘big sur­geon, big knife, big op­er­a­tion.’

National Post (Latest Edition) - - FRONT PAGE - BY TOM BLACK­WELL

When Hen­dri­cus Janssen ar­rived at the Ot­tawa Heart In­sti­tute, the re­tired black­smith was so hob­bled by a po­ten­tially fa­tal nar­row­ing of his heart’s aor­tic valve, he could barely walk 10 paces.

What was worse, the quadru­ple by­pass he had un­der­gone years ear­lier, his ad­vanced age and other fac­tors made the con­ven­tional treat­ment — an open­heart op­er­a­tion to re­place the de­fec­tive valve — too risky. Un­til re­cently, such pa­tients would be left to die a rather mis­er­able death.

In­stead, Mr. Janssen was given an ex­per­i­men­tal new pro­ce­dure that re­places the trauma of ma­jor, open-heart surgery with the key­hole in­ser­tion of a tiny de­vice, part syn­thetic and part pig tis­sue. Within a day or so of get­ting out of hos­pi­tal, he was cut­ting his lawn, trim­ming the cedar hedges around his sub­ur­ban Ot­tawa house and us­ing an acety­lene torch to fash­ion wrought-iron rail­ings.

“I couldn’t do any­thing [be­fore]. All I could do was lie on the bed,” said the now-chip­per 82-year-old. “I im­proved 100% ... I can walk up and down the stairs and I don’t have any pain or tight­ness in my chest.”

The new pro­ce­dure is just the lat­est ad­vance for such min­i­mally in­va­sive surgery in the del­i­cate arena of treat­ing mal­func­tion­ing hearts. What one doc­tor calls a revo­lu­tion in care is mak­ing the con­ven­tional but in­va­sive prac­tice of slic­ing open a pa­tient’s chest, crack­ing the rib cage and tak­ing a scalpel to the or­gan seem al­most an­ti­quated.

“In the 1980s and 1970s, hos­pi­tals made their rep­u­ta­tions on ‘big sur­geon, big knife, big op­er­a­tion,’ ” said Dr. Eric Hor­lick, an in­ter­ven­tional car­di­ol­o­gist at Toronto Gen­eral Hos­pi­tal. “Now the trend has to­tally swung the other way: How small a hole can we do this through? How lit­tle mor­bid­ity can we cause the pa­tient and have it be suc­cess­ful? How quickly can we get some­one to re­cover?”

Treat­ing car­diac ill­ness en­dovas­cu­larly — by thread­ing a catheter into a small in­ci­sion in the groin and through blood ves­sels to the heart — is not com­pletely new. It has been used for a cou­ple of decades to in­flate minia­ture bal­loons or in­stall metal de­vices called stents to open up plaque­clogged ar­ter­ies, an al­ter­na­tive to by­pass op­er­a­tions.

In the past few years, how­ever, a grow­ing num­ber of spe­cial­ists have started ap­ply­ing a sim­i­lar ap­proach to more com­plex re­pairs of “struc­tural” heart prob­lems, faulty valves like Mr. Janssen’s or in peo­ple born with con­gen­i­tal de­fects.

Tak­ing as lit­tle as 45 min­utes — ver­sus open-heart op­er­a­tions that can last hours — they lessen the chance of in­fec­tion, can see pa­tients leave hos­pi­tal the next day and some­times cut weeks off to­tal re­cov­ery time. Plus, squea­mish pa­tients seem to love the idea, doc­tors say.

For all of its al­lure, though, ques­tion marks re­main around the new “in­ter­ven­tional” pro­ce­dures. The “TAVI” treat­ment that Mr. Janssen re­ceived, and a sim­i­larly ground-break­ing op­er­a­tion that Toronto Gen­eral does to fix a dan­ger­ous heart­beat ir­reg­u­lar­ity, for in­stance, have yet to be proven by clin­i­cal tri­als — the gold­stan­dard ev­i­dence for show­ing a treat­ment is ef­fec­tive and safe. Health Canada has not ap­proved ei­ther pro­ce­dure, and On­tario’s medi­care sys­tem does not fund them, leav­ing the hos­pi­tals to find the money else­where.

They are pricey treat­ments, too. The de­vice im­planted in Mr. Janssen costs $25,000, com­pared to about $3,000 for a valve used in con­ven­tional op­er­a­tions, which have well-proven suc­cess. “The cost of this TAVI is outrageous,” said Dr. Thierry Me­sana, chief of car­diac surgery at the Ot­tawa in­sti­tute, who urges that the new treat­ments be em­braced only where science clearly shows they are ben­e­fi­cial.

And though the over­all record is good, not all TAVI cases have had the kind of “Lazarus” re­sults ex­pe­ri­enced by the Ot­tawa pa­tient, with some dy­ing dur­ing the pro­ce­dure, said Dr. Marino Labi­naz, di­rec­tor of in­ter­ven­tional car­di­ol­ogy at the heart in­sti­tute.

In­ter­ven­tional op­er­a­tions that pro­vide treat­ment to pa­tients like that who other­wise would

Pa­tients more and more are just pho­bic, quite afraid of that big in­ci­sion

get none are fine, said Dr. Colin Rose, a Mon­treal car­di­ol­o­gist and med­i­cal skep­tic.

He cau­tioned, though, against us­ing it on peo­ple who would do bet­ter or as well with other, less ex­pen­sive and ex­per­i­men­tal op­er­a­tions or drugs. Dr. Rose pointed to a 2007 trial that found ba­sic drug ther­apy was just as good for sta­ble angina pa­tients as an­gio­plasty, which is by far the most com­mon en­dovas­cu­lar heart op­er­a­tion and has been in use for years.

Doc­tors per­form­ing the new pro­ce­dures say they fully in­form pa­tients of their ex­per­i­men­tal na­ture and the risks in­volved, and are pro­ceed­ing cau­tiously with the tech­nol­ogy. Yet even in cases where stud­ies sug­gest a tra­di­tional open-heart op­er­a­tion might pro­duce slightly bet­ter out­comes, peo­ple of­ten choose the en­dovas­cu­lar tech­nique, Dr. Hor­lick said.

“Pa­tients more and more are just pho­bic, they’re quite afraid of that big in­ci­sion,” he said. “They like that kind of den­tist con­cept.”

Mr. Janssen’s treat­ment at the Ot­tawa Heart In­sti­tute re­versed a nar­row­ing — or “steno­sis” — of the aor­tic valve, the heart’s main, triple-flapped gateway, through which blood surges out to the rest of the body. As the blood flow is curbed by steno­sis, pa­tients suf­fer short­ness of breath, chest pains and, even­tu­ally, heart fail­ure. The con­di­tion be­comes more com­mon as peo­ple grow older. It’s es­ti­mated 180,000 Cana­di­ans suf­fer from it now and that num­ber will grow to “al­most an epi­demic,” as the pop­u­la­tion ages, Dr. Labi­naz said.

Most can un­dergo open-heart surgery, the first-line, proven ther­apy, but one Euro­pean study sug­gests as many as a third are too sick or frag­ile to risk a con­ven­tional op­er­a­tion, mak­ing the in­ter­ven­tional treat­ment the only op­tion.

“To watch peo­ple slowly die, es­pe­cially a mis­er­able death with short­ness of breath, is dif­fi­cult,” Dr. Labi­naz said. “We’re of­fer­ing a com­pas­sion­ate treat­ment for pa­tients whose life ex­pectancy is com­pro­mised.”

The new valve is pushed through blood ves­sels from the groin to the heart, where a bal­loon ap­pa­ra­tus is in­flated that shoves the old, faulty valve to the side and lodges the new one in place. A Euro­pean trial of one such de­vice found that pa­tients who could not have open-heart surg­eries did sig­nif­i­cantly bet­ter with the en­dovas­cu­lar op­er­a­tion than with sim­ple med­i­cal care. The CoreValve used some­times at the in­sti­tute is ap­proved by Health Canada now only on a case-by-case ba­sis un­der its “spe­cial-ac­cess” pro­gram. A U.S. trial is be­ing planned.

At some hos­pi­tals, in­ter­ven­tional car­di­ol­o­gists, heart spe­cial­ists who take fur­ther train­ing in the new tech­niques, and car­diac sur­geons, the ex­perts in con­ven­tional scalpel-based op­er­a­tions, com­pete for pa­tients and the right to do the en­dovas­cu­lar treat­ments, one of many turf wars ush­ered in lately by novel sur­gi­cal tech­nol­ogy.

At the Ot­tawa in­sti­tute, how­ever, Dr. Labi­naz and Dr. Marc Ruel, a heart sur­geon, work side by side on the aor­tic-valve pro­ce­dure, even al­ter­nat­ing their roles dur­ing the op­er­a­tions — part of the hos­pi­tal’s phi­los­o­phy of co-op­er­a­tion be­tween the dis­ci­plines.

The same col­lab­o­ra­tive ap­proach is fol­lowed at Toronto Gen­eral, said Dr. Hor­lick, where in­ter­ven­tion­al­ists, sur­geons and other spe­cial­ists work to­gether to de­cide what type of treat­ment pa­tients re­ceive.

It is break­ing new ground now with an in­ter­ven­tional pro­ce­dure that im­plants a “car­diac plug” to seal off part of the heart where blood clots can form and trig­ger strokes in peo­ple with atrial fib­ril­la­tion — a dan­ger­ously ir­reg­u­lar heart rhythm.

Dr. Hor­lick per­forms the pro­ce­dure along with Dr. Mark Osten, an­other in­ter­ven­tional car­di­ol­go­ist who also spe­cial­izes in heart-valve re­pairs on young adults with con­gen­i­tal heart de­fects.

By the time they are in their 20s, such pa­tients have of­ten un­der­gone two or three ma­jor, open-heart op­er­a­tions. When the valves need re­plac­ing yet again, they are “so thank­ful” to be of­fered the rel­a­tively no-fuss en­dovas­cu­lar treat­ment as an al­ter­na­tive, Dr. Osten said.

He pre­dicts, though, that medicine is only just be­gin­ning to dis­cover ways to use the key­hole tech­nol­ogy on ail­ing hearts.

“The field is evolv­ing quite quickly,” he said. “We’re just at the tip of the ice­berg.”


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