what's new in cardiac

What’s new in What’s new in Cardiac?Cardiac?WatchmanWatchman

Chris Saraceno, DNAP, CRNAChris Saraceno, DNAP, CRNANCANA District 3 & 4 MeetingNCANA District 3 & 4 Meeting

February 4February 4thth, 2017, 2017

disclaimersdisclaimers• NONENONE

Watchman Watchman boston Scientificboston Scientific

• Atrial fibrillationAtrial fibrillation• Most common cardiac arrythmiaMost common cardiac arrythmia

• Morbidity & mortality of AFibMorbidity & mortality of AFib• Strokes Strokes

• 15-20% of CVAs from Afib15-20% of CVAs from Afib• ~30% CVAs in persons > 80 y.o.~30% CVAs in persons > 80 y.o.

• Particularly devastatingParticularly devastating• Large emboliLarge emboli

Major culpritMajor culprit• Purpose of the LAAPurpose of the LAA

• Contribute to atrial kickContribute to atrial kick• Loss of this function in AfibLoss of this function in Afib

• Atrial natriuretic peptide (ANP)Atrial natriuretic peptide (ANP)

• Reason for clot formation in the LAAReason for clot formation in the LAA• Shape of LAAShape of LAA

Major culpritMajor culprit

LAA MorphologyLAA Morphology• A. Chicken wingA. Chicken wing

• B. WindsockB. Windsock• Most suitable for Most suitable for

WatchmanWatchman

• C. C. Broccoli/cauliflowerBroccoli/cauliflower

• D. CactusD. Cactus

Prevention of strokes Prevention of strokes from AFibfrom AFib

• Stop the arrythmia:Stop the arrythmia:• Medical regimen Medical regimen

• antiarrythmicsantiarrythmics• Radiofrequency Ablation (RFA)Radiofrequency Ablation (RFA)

• Problem:Problem:• Typically, Afib is not eradicated with either Typically, Afib is not eradicated with either

treatmenttreatment• ACC Guidelines do not recommend d/c of oral ACC Guidelines do not recommend d/c of oral

anticoagulants (OAC)anticoagulants (OAC)

** decreased risk of CVA in patients with RFA than ** decreased risk of CVA in patients with RFA than withoutwithout

Prevention of strokes from Prevention of strokes from AFibAFib

• AnticoagulantsAnticoagulants• Warfarin-standard of careWarfarin-standard of care

• Drug interactionsDrug interactions• Risk of bleedingRisk of bleeding• Narrow therapeutic rangeNarrow therapeutic range• Frequent blood testingFrequent blood testing• Poor compliancePoor compliance

• Diet restrictions due to food interactionsDiet restrictions due to food interactions

• Pradaxa®, Xarelto®, Eliquis®Pradaxa®, Xarelto®, Eliquis®• Risk of bleedingRisk of bleeding• No antidoteNo antidote


Stroke RiskStroke Risk• CHACHA22DSDS22-VASc -VASc

• CHF hxCHF hx• HTN hxHTN hx• Age Age

• 65-74 65-74 • >> 75 75 22

• DMDM22

• Stroke/TIA/TE hxStroke/TIA/TE hx22

• Vascular diseaseVascular disease

BleedingBleeding Risk Risk• HAS-BLEDHAS-BLED• HTNHTN• AbnAbn

• Renal fxnRenal fxn• Liver fxnLiver fxn

• StrokeStroke• BleedingBleeding• Labile INRsLabile INRs• Elderly: Age>65Elderly: Age>65• DrugsDrugs

• Alcohol Alcohol **Prevention needs to weigh risk vs benefit


Stroke RiskStroke Risk• CHACHA22DSDS22-VASc-VASc

Bleeding RiskBleeding Risk• HAS-BLEDHAS-BLED

Score

Risk of bleeding

0-1 Low risk (1.1%)2 Intermediate risk (1.9%)>3 High risk (4.9%)

Score

Risk of Stroke

0 Low risk (0%)1 Intermediate risk (0.6%)>1 High risk (3%)

Prevention of strokesPrevention of strokes

• LAA closureLAA closure• SurgicalSurgical

• Atriclip deviceAtriclip device• CPBCPB

• Flaccid heartFlaccid heart

Watchman Watchman DeviceDevice

FDA approved in FDA approved in 20152015

For non-valvular For non-valvular AFibAFib

WatchmanWatchman• Patient considerationsPatient considerations

• Non-valvular AfibNon-valvular Afib• High stroke risk score*High stroke risk score*

• CHACHA22DSDS22-VASc-VASc• High bleeding risk score*High bleeding risk score*

• HAS-BLEDHAS-BLED

*high stroke AND bleeding risk score = most *high stroke AND bleeding risk score = most suitablesuitable

Watchman Watchman preprocedurepreprocedure

• CTCT• AngiographyAngiography

• ShapeShape• Orifice sizeOrifice size• DepthDepth• Width Width

Watchman: Watchman: procedureprocedure

• AccessAccess• Femoral veinFemoral vein

• TranseptalTranseptal

• GA/MACGA/MAC

• TEETEE

• Fluoroscopic Fluoroscopic

WATCHMAN: WATCHMAN: • Healing:Healing:

Watchman: Watchman: Anesthetic considerationsAnesthetic considerations

• Cath labCath lab• EPs or interventional cardiologistsEPs or interventional cardiologists

• TranseptalTranseptal• AnticoagulantsAnticoagulants• Complications Complications

• Procedural strokeProcedural stroke• Pericardial effusionPericardial effusion• Air embolismAir embolism• Cardiac perforationCardiac perforation• Device embolizationDevice embolization• Vascular Vascular

• Bleeding, hematoma, pseudoaneurysmBleeding, hematoma, pseudoaneurysm

Amplatzer, Amplatzer, St jude medicalSt jude medical

• Amplatzer Amplatzer

Amplatzer, Amplatzer, St jude medicalSt jude medical

• Amplatzer Cardiac Amplatzer Cardiac PlugPlug

• Amplatzer AmuletAmplatzer Amulet

Other devicesOther devices•Coherex Wavecrest LAA occluderCoherex Wavecrest LAA occluder•Still others:Still others:

• OCCLUTECH LAA OCCLUDEROCCLUTECH LAA OCCLUDER• LIFETECH LAA OCCLUDER: LambreLIFETECH LAA OCCLUDER: Lambre• Cardia ultrasept LAA OCCLUDERCardia ultrasept LAA OCCLUDER• AEGIS-ECG guided LAA capture and AEGIS-ECG guided LAA capture and

ligation systemligation system• EPITEK- fiberoptic endoscope EPITEK- fiberoptic endoscope

mediatedmediated

LARIAT™LARIAT™• LARIAT™ DeviceLARIAT™ Device• SentreheartSentreheart

• Redwood City, CARedwood City, CA

Post watchmanPost watchman• Oral anticoagulants**Oral anticoagulants**• Dual antiplatelet therapyDual antiplatelet therapy

TAVRTAVRTranscatheter Aortic Valve Transcatheter Aortic Valve

ReplacementReplacement

AORTIC valveAORTIC valve• Valve areaValve area

• Normal: 2.6-3.5 cmNormal: 2.6-3.5 cm22

• Moderate: 1-1.5 cmModerate: 1-1.5 cm22 • Severe: <1.0 cmSevere: <1.0 cm22

• Pressure gradientPressure gradient• Normal: < 10 mmHgNormal: < 10 mmHg• Moderate: 0.6-0.85 mmHgModerate: 0.6-0.85 mmHg• Severe: < 0.6 mmHgSevere: < 0.6 mmHg

Aortic stenosisAortic stenosis• Mortality with onset Mortality with onset

of symptoms:of symptoms:• Angina: first symptom Angina: first symptom

in 2/3 ptsin 2/3 pts• < 5 yrs< 5 yrs

• Syncope: first symptom Syncope: first symptom in 15-30% of ptsin 15-30% of pts• 3-4 yr life 3-4 yr life

expenctancyexpenctancy• CHFCHF

• 1-2 yr life 1-2 yr life expenctancyexpenctancy

• Risk of sudden cardiac Risk of sudden cardiac deathdeath

Aortic valve Repair/replacementAortic valve Repair/replacement

• Current treatmentCurrent treatment• Gold standard: AVRGold standard: AVR• Morbidity and mortalityMorbidity and mortality

• Non-surgical candidates?Non-surgical candidates?

• PARTNER TRIALPARTNER TRIAL• Placement of Aortic Transcatheter ValvesPlacement of Aortic Transcatheter Valves

• Superior to standard therapy Superior to standard therapy • Equivalent to surgery in high-risk patientsEquivalent to surgery in high-risk patients

Sapien/sapien xtSapien/sapien xt• Edwards LifesciencesEdwards Lifesciences

• First human implant 2002First human implant 2002• FDA approved 2011 FDA approved 2011

corevalvecorevalve

• Medtronic Medtronic • Self-expandingSelf-expanding

Pre-procedure evalPre-procedure eval• EchoEcho

• ANNULUS SIZEANNULUS SIZE• CalcificationCalcification• Severity of ASSeverity of AS• Other valve diseaseOther valve disease

• AngiographyAngiography• Vascular surrounding aortic valve **aortaVascular surrounding aortic valve **aorta

• Heart cathHeart cath• Pulmonary HTN?Pulmonary HTN?• CAD?CAD?

• CTCT• IliacsIliacs• Femorals Femorals

Sapien/sapien xtSapien/sapien xt

Valve Sheath Minimal arteral diameter

Sapien 23 mm 22 F 7 mm26 mm 24 F 8 mm

Sapien XT 23 mm 18 F 6 mm26 mm 19 F 6.5 mm

Edwards Lifesciences

Tavr procedure: Tavr procedure: femoral femoral approachapproach

• PrepPrep

• TimeoutTimeout

• EquipmentEquipment

• AntibioticAntibiotic

• Access Access

• Femoral arterial accessFemoral arterial access• Aortic angiographyAortic angiography

• Femoral venous accessFemoral venous access• Pacer wire in right ventriclePacer wire in right ventricle

• Rapid ventricular pace @ Rapid ventricular pace @ 180-200 bpm180-200 bpm

• Heparinize prior to Heparinize prior to traversing aortic valvetraversing aortic valve

• Valvuloplasty with rapid Valvuloplasty with rapid pacingpacing

• DeliveryDelivery

• Balloon deflated & Balloon deflated & withdrawnwithdrawn

Tavr procedure: Tavr procedure: femoral femoral approachapproach

ApproachesApproaches

ApproachesApproaches• TransaxillaryTransaxillary

Hybrid orHybrid or

Tavr complicationsTavr complications• Structural failure-rareStructural failure-rare• Vascular injury/ perforationVascular injury/ perforation

• Iliacs, femorals, aortaIliacs, femorals, aorta• RETROPERITONEAL BLEEDRETROPERITONEAL BLEED• IVUSIVUS

• ThrombusThrombus• Heparinize, ACT 250-300 seconds, check q Heparinize, ACT 250-300 seconds, check q

30 minutes30 minutes

• Cerebral embolizationCerebral embolization

Tavr complicationsTavr complications• Acute coronary obstructionAcute coronary obstruction

• Displaced native valveDisplaced native valve• Device Device • Coronary ostia not far from aortic Coronary ostia not far from aortic

valvevalve• even smaller in AS ptseven smaller in AS pts

** Left main: CPB, device ** Left main: CPB, device explantation, AVRexplantation, AVR

Tavr complicationsTavr complications• Mitral valve injuryMitral valve injury

• Impede anterior Impede anterior leaflet of mitral valve leaflet of mitral valve

Tavr complicationsTavr complications• Annular and aortic root Annular and aortic root

rupture/dissectionrupture/dissection• Device too largeDevice too large• Risk increases with manipulation of deviceRisk increases with manipulation of device

• Perivalvular regurgitationPerivalvular regurgitation• Inappropriate sizing- too smallInappropriate sizing- too small

• * embolize device* embolize device• Malposition (valve in valve)Malposition (valve in valve)• Under expansion of deviceUnder expansion of device

Tavr complicationsTavr complications• AV blockAV block

• 1.8-8.5%1.8-8.5%• AnnuloplastyAnnuloplasty• RBBB- increases RBBB- increases

risk of AV blockrisk of AV block

• Pacemaker Pacemaker

Tavr complicationsTavr complications• Cardiac perforation & tamponadeCardiac perforation & tamponade

• Echo-pericardiocentesisEcho-pericardiocentesis

• Emolization of deviceEmolization of device• Into LV- fatalInto LV- fatal• Inverted valve - fatalInverted valve - fatal

Tavr complicationsTavr complications• Cardiogenic shockCardiogenic shock

• Patients with severe Patients with severe LV dysfxn + rapid LV dysfxn + rapid pacingpacing

• Muscle collapsesMuscle collapses• ? fluid? fluid

Anesthetic Anesthetic considerationsconsiderations

• GA vs MAC*GA vs MAC*• TEETEE• APPROACHAPPROACH

• 2 lg bore IVs2 lg bore IVs• Arterial lineArterial line• 2 pacers2 pacers• VasopressorsVasopressors• Cardiac CRNACardiac CRNA• Cardiac anesthesiologistCardiac anesthesiologist


• TransapicalTransapical• Requires GARequires GA• Left thoracotomyLeft thoracotomy• Double lumen tubeDouble lumen tube

• Transaortic/ Transaortic/ transaxillarytransaxillary• Requires GARequires GA• Double lumen tube/BBDouble lumen tube/BB


• OR staffOR staff• Cath lab staffCath lab staff• CPB machineCPB machine• FluoroFluoro• PerfusionPerfusion• 3 big dogs3 big dogs

PARTNER IIA TRIALPARTNER IIA TRIAL• December 2011-December 2011-

November 2013November 2013

• Severe ASSevere AS

• Intermediate riskIntermediate risk

• 1011 patients1011 patients

• RandomizedRandomized

• 57 centers in U.S. 57 centers in U.S. and Canadaand Canada

• Results:Results:• Pacemaker Pacemaker

requirementsrequirements• No change from No change from

PARTNER TrialPARTNER Trial• Aortic regurgitationAortic regurgitation

• 3.7%3.7%• Not related to Not related to

adverse outcomesadverse outcomes

2016 FDA approves Sapien XT & Sapien 3 for intermediate risk

Sapien 3Sapien 3• Base on data from Base on data from

PARTNER II TrialPARTNER II Trial

• Paravalvular leakParavalvular leak

• Skirt of fabric at Skirt of fabric at base of devicebase of device

VARCVARC• VALVE ACADEMIC RESEARCH VALVE ACADEMIC RESEARCH

CONSORTIUMCONSORTIUM

• Complications Complications • Stroke & TIAsStroke & TIAs• ARAR• Vascular access complicationsVascular access complications• Conduction system disturbancesConduction system disturbances• Coronary artery occlusionCoronary artery occlusion• ARFARF

MitraClipMitraClip™™ abbott Vascularabbott Vascular

Mitral regurgitationMitral regurgitationMost common insufficient valve disease

Current therapyCurrent therapy• Mitral repairMitral repair

• Low risk mortality: 1.4%Low risk mortality: 1.4%• Hight risk mortality/ age > 80: 11%Hight risk mortality/ age > 80: 11%

• Mitral replacementMitral replacement• Low risk mortality: 1.6%Low risk mortality: 1.6%• Hight risk mortality/ age > 80: 18.9%Hight risk mortality/ age > 80: 18.9%

• EVEREST TRIALEVEREST TRIAL• EndoVascular Edge- to-Edge REpair StudyEndoVascular Edge- to-Edge REpair Study

Alfieri procedureAlfieri procedure

• SurgicalSurgical• Alfieri suture MV repair techniqueAlfieri suture MV repair technique

• Annuloplasty Annuloplasty • Anterior and posterior leaflets Anterior and posterior leaflets

• SternotomySternotomy• CPBCPB

Alfieri Alfieri procedureprocedure

Anterior 2 leaflet Anterior 2 leaflet A2A2

Posterior leaflet Posterior leaflet P2P2

Figure 8Figure 8

Mitraclip, Mitraclip, Abbott vascularAbbott vascular

Patient selectionPatient selection• Moderate to severe MRModerate to severe MR

• Non-surgical candidatesNon-surgical candidates

• Excessive co-morbiditiesExcessive co-morbidities

• Valve:Valve:• Mitral valve orifice area < 4 Mitral valve orifice area < 4

cmcm22

• Degenerative MR: flail Degenerative MR: flail height/ widthheight/ width

• Functional MR: grasping Functional MR: grasping areaarea

exclusionexclusion• Recent MIRecent MI• MR with rheumatic heart diseaseMR with rheumatic heart disease• EndocarditisEndocarditis• Abnormal leafletAbnormal leaflet

procedureprocedure• Prep, time-outPrep, time-out

• Access femoral veinAccess femoral vein

• Transeptal punctureTranseptal puncture• Heparin, ACT >250, check q 30 Heparin, ACT >250, check q 30

minmin

• Steerable Guide catheter Steerable Guide catheter (SGC)(SGC)

• Clip Delivery SystemClip Delivery System

• Mitraclip above mitral valveMitraclip above mitral valve

• Mitral clip into LVMitral clip into LV

• Grasp leafletsGrasp leaflets

procedureprocedure

procedureprocedure

• AssessAssess• Echo & fluoroEcho & fluoro• MR < 2+MR < 2+• Improved COImproved CO• Decreased wedgeDecreased wedge• Decreased LVEDV Decreased LVEDV

pressurepressure

• Mitraclip releaseMitraclip release• Position and reduction Position and reduction

in MR satisfactoryin MR satisfactory• Reposition Reposition • Second clipSecond clip

complicationscomplications• Tear mitral leaflet(s)Tear mitral leaflet(s)

• Worsen MRWorsen MR

• Mitral stenosisMitral stenosis• Acute or chronicAcute or chronic

• Clip surfaces endothelialize Clip surfaces endothelialize

• Create an atrial-septal defectCreate an atrial-septal defect• Rupture of atrial wallsRupture of atrial walls• Cardiac tamponadeCardiac tamponade

• Echo-guided pericardiocentesisEcho-guided pericardiocentesis


• GAGA• 2 large bore IVs2 large bore IVs• Arterial lineArterial line• VasopressorsVasopressors

• Phenylephrine vs ephedrinePhenylephrine vs ephedrine• ? fluids? fluids

• Patient Patient • LV dysfxnLV dysfxn• Pulmonary HTNPulmonary HTN• ? Afib? Afib

Cath lab/ hybrid ORCath lab/ hybrid OR

FutureFuture• EVEREST II TrialEVEREST II Trial

• 20152015• 5 year follow up:5 year follow up:

• If intervention required (surgery): first 6 If intervention required (surgery): first 6 monthsmonths

• After 1 year- cardiac remodelingAfter 1 year- cardiac remodeling• Clinical outcomes similar to surgical Clinical outcomes similar to surgical

approachapproach• ** greater level of safety** greater level of safety

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