Valvular Procedure: John D. Carroll, MD FACC MSCAI Professor of Medicine. University of Colorado

Transcription

1 TAVR is Here and Mainstream: With the Risk of Stroke During Any Valvular Procedure: Is There Any Role for Embolic Protection? John D. Carroll, MD FACC MSCAI Professor of Medicine Director of Interventional Cardiology University of Colorado

2 John Carroll Investigator in PARTNER 2 and Medtronic Low Risk TAVR/SAVR studies. Member of Steering Committee for STS- Member of Steering Committee for STS- ACC TVT Registry

3 You have a TAVR program at your facility with good outcomes and your stroke rate seems to be at the national average. A 78 year old patient with COPD presents for either TAVR or traditional valve surgery. He has non-symptom limiting PAD and clearly wants to have TAVR rather than the open procedure. He and his family have seen reports of noninvasive tests after TAVR suggesting that the majority of patients do have new MRI defects after the procedure. He is already losing some of his memory. Is there anything else you might consider when you do the TAVR procedure?

4 Commercial TAVR Records Submitted to the TVT Registry Over 100,000 TAVR patients are in the TVT Registry may see 50,000 more. S ource: S T S /A CC T VT R egistry Database.asof Jul17,2017

5 Major Outcomes (Not Adjusted for Risk) 8.00% 7.00% Mortality 6.00% 5.00% 6.80% 6.50% 5.80% 5.20% 5.10% 4.00% 4.00% In-Hospital 3.70% 30 Day 3.00% 2.80% 2.80% 2.00% 1.80% 1.00% 0.00% % 1.60% 1.40% 1.20% 1.00% 0.80% 0.60% 0.40% 0.20% 0.00% 1.60% Major Vascular Complications 1.20% 1.30% 1.20% % 3.00% 7.00% 6.90% Life Threatening Bleeding 2.50% 2.50% 2.50% 2.60% 6.00% 6.00% 2.30% 2.20% 2% 2.20% 2.00% 2.10% 2.00% 5.00% 1.80% 4.00% 3.80% 3.00% 3.00% 2.40% 2.00% 1.00% Stroke 1.50% InHospital 30 Day 1.00% 0.50% 0.00% %

6 M ajoro utcom esfrom T AVR haveim proved and avolum e- outcom erelationship existsform ajor outcom esexceptfor stroke. Unadjusted (orange)and risk- adjusted (blue)frequency of outcomes. The p value < 0.05 for linearity suggests a nonlinear relationship. The orange- and blue-colored bands represent 95% confidence limits, which are broader for stroke due to the low rate of site-reported stroke and the fewer hospital sites contributing cases. Carro ljd etal.ja m Co lcardiol2017;70:29 41.

7 Strokes in the TAVR patient have multiple mechanisms and variable timing relative to TAVR procedure. Cerebral protection from filters and deflectors has potential for becoming a universal adjunctive technology FDA approval of the Sentinel Cerebral Protection System by Claret Medical makes this a consideration for all TAVR programs.

8 How frequently stroke is diagnosed is highly dependent on how hard you look: Standard clinical surveillance Serial neurological assessment using the NIHSS Radiographic CNS infarcts identified using a diffusion-weighted 1.5-T or 3.0-T MRI scanner Volu me and nu mberofrad iographic brain Volu me and nu mberofrad iographic brain les ions

9 Meller et al. CCI 2014:83:502-8.

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18 Q uestion1:s afety R esults T hepanelw as unanim ously in agreem entthatthedeviceis safein thecontext ofthet AVR procedure. Q uestion2:effectivenessendpoints In general,thepanelexpressedconcerns regardingtheadequacy andclinicalm eaningfulness oftheeffectiveness endpointfornew lesion volum eas evaluatedw ithdiffusion-w eightedm agneticresonanceim aging(dw -M R I). Q uestion3:effectivenessr esults T hepanelgenerally indicatedthattherew as no clearcorrelation betw een the clinicaloutcom es ofinterest(strokeandneurocognitiveassessm ents)andthe radiographicfindings (DW -M R Iassessm entofobservednew lesion volum e reduction in protectedterritories betw een testandcontrolpatients). Q uestion4:debriscapture T hepanelagreedthatcapturingdebris in 99% ofpatients is m eaningful. Q uestion5:n eurocognitiveo utcom es T hepanelagreedthattheresults oftheneurocognitiveassessm ents didnot dem onstrateaclinically-significantbenefit.

19 Q uestion8:benefit& R isk In general,thepanelfeltthatthetrialfailedto dem onstrate benefitin term s ofareduction in strokeorim provem entin neurocognitiveoutcom es;how ever,thepaneldidindicatethat preventingdebris from reachingthecerebralcirculation is a benefitofthes entineldevice,andthatpreventingsom edebris from reachingthecerebralcirculation is betterthan allow ingall ofthedebris to reachthecerebralcirculation.in lightofthe totality ofinform ation,this levelofbenefitanddegreeof uncertainty is acceptablegiven thatthis is an adjunctive procedurew ithm inim aladdedrisks. Q uestion9:p ost-m arketdata T hepanelagreedthatpost-m arketdatacollection w ouldbe valuableto supportandbetterdefinetheprobablebenefits of thedevice.

20 The Sentinel Cerebral Protection System is indicated for use as an embolic protection device to capture and remove thrombus/debris while performing transcatheter aortic valve replacement procedures. The diameters of the arteries at the site of filter placement should be between 9 15 mm for the brachiocephalic and mm in the left common carotid.

21 A total of 802 consecutive patients were enrolled. The Sentinel cerebral embolic protection device (Claret Medical Inc., Santa Rosa, California) was used in 34.9% (n. 280) of consecutive patients. In 65.1% (n. 522) of patients TAVR was performed in the identical setting except without cerebral embolic protection. W ithuseofcerebralem bolicprotectionrateofdisablingand non-disablingstrokew assignificantly reduced from 4.6% to 1.4% (p.0.03;oddsratio:0.29,95% confidenceinterval:0.10 to0.93)inthepropensity-m atched population(n.560). (JA m CollCardiolIntv2017;-:- -)

22 A total of 28 filters (2 from each patient) were analyzed. Microscopically, debris was identified in all 14 patients. The most common tissue types were acute thrombus and small fragments of foreign material, which were found in 12 patients (85.7%) each. Frerker et al. J Am Coll Cardiol Intv 2016;9:171 9)

23 The primary end point was freedom from clinical or radiographic CNS infarction at 7 days after the procedure CO N CL U S IO N S A N D R EL EVA N CEA m ongpatientsundergoings AVR, cerebralem bolicprotectiondevicescom paredw ithastandardaortic cannuladid notsignificantly reducetheriskofcn S infarctionat7 days.p otentialbenefitsforreductionindelirium,cognition,and sym ptom aticstrokem eritlargertrialsw ithlongerfollow -up. JAMA. 2017;318(6):

24 A large randomized trial is ongoing (enrollment completed), the SENTINEL trial with the aim of randomizing about 300 patients and assessing the efficacy (superiority) and safety (noninferiority) of the Claret Medical Sentinel cerebral protection device in TAVR by MRI assessment, neurologic and neurocognitive tests, and histopathology examination. Helene Eltchaninoff, MD. The Pros and Cons of Cerebral Embolic Protection During Transcatheter Aortic Valve Replacement. JA C C : C A. 9, N O. 2 0, E ltc haninoff O C T O B E R 2 4, : R D IO V A S C U L A R IN T E R V E N T IO N S V O L

25 TAVR, as well as many left-sided transcatheter procedures and open-heart surgery, has a risk of embolic debris reaching the cerebral circulation. As a result clinical strokes may occur, MRI shows lesions, and potential neurocognitive issues are possible. The role of cerebral protection devices is under active investigation with one device having achieved FDA approval. The evidence of benefit from cerebral protection remains mixed, but its safety, ability to capture debris, and likelihood of reducing some clinical events are factors making TAVR sites evaluate if and when to adopt this adjunctive technology. Currently reimbursement is not approved and an application to achieve reimbursement has been submitted.

26 You have a TAVR program at your facility with good outcomes and your stroke rate seems to be at the national average. A 78 year old patient with COPD presents for either TAVR or traditional valve surgery. He has non-symptom limiting PAD and clearly wants to have TAVR rather than the open procedure. He and his family have seen reports of noninvasive tests after TAVR suggesting that the majority of patients do have new MRI defects after the procedure. He is already losing some of his memory. Is there anything else you might consider when you do the TAVR procedure?

27 Conscious sedation to be used Cerebral protection is feasible and safe but no definitive data that it will prevent strokes or neurocognitive decline.

28 1. The Embol-X (Edwards Lifesciences) intraaortic filtration device has been shown to be safe and capture emboli (with a heparin-coated polyester mesh filter), but not reduce stroke in a mostly low-risk population undergoing coronary artery bypass graft surgery.8 2. The CardioGard (CardioGard) device extracts both particulate and gaseous emboli through suction-based extraction