PUSHING THE ANATOMIC LIMITS OF EVAR WE SHOULD MOST PATIENTS DO VERY WELL MY OPPONENT. Seems like a nice guy.. MY OPPONENT DISCLOSURES.

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1 MY OPPONENT PUSHING THE ANATOMIC LIMITS OF EVAR WE SHOULD MOST PATIENTS DO VERY WELL Seems like a nice guy.. DISCLOSURES MY OPPONENT INDIVIDUAL None INSTITUTIONAL Cook, Inc W. L. Gore, Inc Seems like a nice guy.. 1

2 MY OPPONENT MY OPPONENT But after residency at UC Davis he did leave California Judgement..???? Fearless??? MY OPPONENT MY OPPONENT Fearless Erudite 2

3 MY OPPONENT Reviewed 10,228 patients, using AAA sac enlargement as a marker for treatment failure Found 41% 5-year enlargement Off-label device use increased the risk of sac enlargement Database No clinical information, but used to make a clinical recommendation If a large number of the enlarging aneurysms were easily treated with a repeat intervention, the clinical implications of this endpoint would, to some extent, be mitigated. Database No clinical information, but used to make a clinical recommendation Database No clinical information, but used to make a clinical recommendation If a large number of the enlarging aneurysms were easily treated with a repeat intervention, the clinical implications of this endpoint would, to some extent, be mitigated. NEVERMIND 3

4 Imaging data Basis for submitting studies to M2S introduces potential bias (non-consecutive, study vs service ) Imaging data Basis for submitting studies to M2S introduces potential bias (non-consecutive, study vs service ) We are unable to assess this potential concern with the available data. However, if the impetus [for image submission to M2S] were driven by anatomic complexity, the aneurysms would be larger. The average age and proportion of men in the M2S and Medicare data sets are similar. These findings suggest that the results from the M2S database are generalizable. Imaging data Basis for submitting studies to M2S introduces potential bias (non-consecutive, study vs service ) Process No information regarding the interval between the preop study and the time EVAR was performed We are unable to assess this potential concern with the available data. However, if the impetus [for image submission to M2S] were driven by anatomic complexity, the aneurysms would be larger. The average age and proportion of men in the M2S and Medicare data sets are similar. These findings suggest that the results from the M2S database are generalizable. 4

5 Process No information regarding the interval between the preop study and the time EVAR was performed If enough time did elapse between the pre- EVAR baseline CT scan and the EVAR procedure, it is conceivable that the AAA sac enlargement observed may have occurred before the AAA repair. Database No clinical information, but used to make a clinical recommendation Imaging data Basis for submitting studies to M2S provides potential bias (study vs service ) Process No information regarding the interval between the preop study and the time EVAR was performed Time interval ( ) No device specific data Process No information regarding the interval between the preop study and the time EVAR was performed If enough time did elapse between the pre- EVAR baseline CT scan and the EVAR procedure, it is conceivable that the AAA sac enlargement observed may have occurred before the AAA repair. Since light travels faster than sound, people appear bright until you hear them speak Unknown NEVERMIND 5

6 EVAR EVAR IS IT EECTIVE? IS IT? IS IT ETHICAL? Standard indication, adulterated device, standard insertion, anatomy outside Dillavou et al, J Vasc Surg, 2003 EVAR EVAR Standard indication, adulterated device, standard insertion, anatomy outside NECK Too short Too angulated Too wide ILIACS Too short Too wide Dillavou et al, J Vasc Surg,

7 EVAR EVAR Standard indication, adulterated device, standard insertion, anatomy outside Standard indication, adulterated device, standard insertion, anatomy outside Uflacker, JVIR, 2006 EVAR EECTIVE Standard indication, insertion, anatomy W-A-A-Y outside adulterated device, standard insertion, anatomy outside Kasirajan, JEVT, 2011 Little data specifically comparing the outcome of onlabel and off-label EVAR Neither physicians nor manufacturers may promote outside use of an approved device Physicians worry about the implication of publishing the results of non-ifu device use Manufacturers worry about the implication of distributing published results of non-ifu device use 7

8 EECTIVE EECTIVE RUPTURE STUDY YEAR N DEVICE / NON-IFU ANATOMY Torsello Endurant 121/56 L, A Hyhlik-Durr Endurant 40/50 L, A STUDY AAA RUPTURE (any time) AAA RUPTURE (30 d) AAA RUPTURE (late) AbuRahma Excluder Ancure Aneurx Zenith Abbruzzese Aneurx Zenith Excluder EUROSTAR Zenith Talent Excluder Aneurx All others 195/41 L, (A) 343/222 L, D, A 6286/1268 Large iliacs Boult No data 895/66 L, D, A EUROSTAR Zenith Talent Excluder 4031/1152 A, (L) Abbruzzese Fulton NSS EUROSTAR Zenith Talent 2822/677 L, (D), (A) Fulton Aneurx 59/25 L, A Dillavou Ancure 115/91 L, D, A EECTIVE MORTALITY EECTIVE MIGRATION STUDY Torsello Hyhlik- Durr DEATH PERIOP DEATH OVERALL (any time) DEATH OVERALL (late) AAA DEATH (any time) AAA DEATH 1 YR AAA DEATH 5 YR ALIVE 1 YR ALIVE 3 YR ALIVE 5 YR STUDY Torsello MIGRATION (any time) MIGRATION (2 YR) MIGRATION (4 YR) MIGRATION (early) MIGRATION (late) Abu Rahma Abbruz zese Boult Fulton NSS SIG NSS Abbruzze se Fulton Dillavou NSS Dillavou 8

9 EECTIVE CONVERSION EECTIVE ENDOLEAK STUDY Torsello Abbruzzese Fulton CONVERSION (any time) CONVERSION (30 d) CONVERSION (late) NSS STUDY Torsello Hyhlik-Durr AbuRahma Fulton Dillavou INTRAOP TYPE 1A EL EARLY TYPE 1A EL 94.0 LATE TYPE 1A EL SIG 84.0 EECTIVE PATENCY EECTIVE REINTERVENTION STUDY Torsello Hyhlik-Durr AbuRahma Abbruzzese Dillavou GRAFT KINK NSS GRAFT THROMBOSIS PATENCY 3 YR 89.0 STUDY Torsello Hyhlik- Durr Abu Rahma Abbruzzese Fulton Dillavou PRE-D/C REINTERV LATE REINTERV EL LATE REINTERV ANY NSS REINTERV 1 YR 92.0 REINTERV 5 YR

10 EVAR EVAR The only mystery in life is why the kamikaze pilots wore helmets. Unknown IS IT EECTIVE? IS IT? IS IT ETHICAL? EECTIVE YES Pick the best device for that anatomic challenge The more IFU violations, the worse the outcome GO TO PLAN B Don t keep trying to put a square peg into a round hole GO TO PLAN B Does the FDA regulate medical practice? 1. yes 2. no 43% 57%

11 the FDA does regulate the practice of medicine the FDA does regulate the practice of medicine Good medical practice and the best interest of the patient require that physicians use legally available drugs, biologics and devices according to their best knowledge and judgement. If physicians use a product for an indication not in the approved labeling, they have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product s use and effects. Use of a marketed product in this manner when the intent is the practice of medicine does not require the submission of an IND, IDE or review by an institutional review board. Good medical practice and the best interest of the patient require that physicians use legally available drugs, biologics and devices according to their best knowledge and judgement. If physicians use a product for an indication not in the approved labeling, they have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product s use and effects. Use of a marketed product in this manner when the intent is the practice of medicine does not require the submission of an IND, IDE or review by an institutional review board. the FDA does regulate the practice of medicine Good medical practice and the best interest of the patient require that physicians use legally available drugs, biologics and devices according to their best knowledge and judgement. If physicians use a product for an indication not in the approved labeling, they have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product s use and effects. Use of a marketed product in this manner when the intent is the practice of medicine does not require the submission of an IND, IDE or review by an institutional review board. YES valid new uses for dugs already on the market are often first discovered through serendipitous observations and therapeutic innovations, subsequently confirmed by well-planned and executed clinical investigations [A]ccepted medical practice often includes drug use that is not reflected in approved drug labeling US FDA 9/9/08 off-label usage of medical devices (use of a device for some other purpose than that for which it has been approved by the FDA) is an accepted and necessary corollary of the FDA s mission to regulate in this area without directly interfering with the practice of medicine. In some circumstances, an off-label use of a particular drug or device may even define the standard of care. Buckman Co v Plaintiff s Legal Comm, 531 US 341, 350, (2001). 11

12 YES physician may, as part of the practice of medicine, lawfully prescribe a different dosage for his patient, or may otherwise vary the conditions of use from those approved in the package insert [1972 Fed Reg] When is the intent no longer the practice of medicine? labeling is not intended either to preclude the physician from using his best judgement in the interest of the patient, or to impose liability if he does not follow the package insert [1972 Fed Reg] [federal law] does not.limit the manner in which a physician may use an approved drug. Once a product has been approved for marketing, a physician may prescribe it for uses or in treatment regimens or patient populations that are not included in approved labeling. [FDA Drug Bulletin, Apr 1982] [o]nce a drug or medical device has been approved or cleared by the FDA, generally, healthcare professionals may lawfully use or prescribe that product for uses or treatment regimens that are not included in the product s approved labeling [FDA Guidance, 2009] When is the intent no longer the practice of medicine? 1. >1 patient 2. 5 patients 52% patients patients When is the intent no longer the practice of medicine? 21% 10% 17% N= 47 patients

13 When is the intent no longer the practice of medicine? FDA ADVICE: When is the intent no longer the practice of medicine? FDA ADVICE: THE NON IFU ELEPHANT Prescription drugs 25 60% Cancer drug use 65% AIDS patients 80% (at least one drug) DES for PCI 60% Kidney dialysis equipment use 70% Facilitates advances in patient care Allows more rapid evolution of treatments and techniques Complete prohibition would impractical impossible hurt patient care 13

14 EVAR IS IT EECTIVE? IS IT? IS IT ETHICAL? We must beware of needless innovation, especially when guided by logic. Winston Churchill ETHICAL With disclosure to the patient Preferably in a setting that insures data collection Study Required registry 14