TAVR: Criteria, Procedure, Pre & Post Care
TAVR: Criteria, Procedure, Pre & Post CareSARAH JOHNSON, RN, MSN, ACNP- BC3/6/2019
Aortic Stenosis Occurs when the heart's aortic valvenarrows. The narrowing prevents the valve fromopening fully, which obstructs bloodflow from your heart into your aorta andonward to the rest of his/her body. Usually when aortic valve stenosisbecomes severe and symptomatic, perACC/AHA guidelines, the native valveshould be replaced. Left untreated, aortic valve stenosismay lead to sudden death.2
Aortic StenosisGross specimen of minimally diseased aortic valve (left) and severely stenotic aortic valve (right)Images courtesy of Renu Virmani MD at the CVPath Institute3
Prevalence of Aortic Stenosis16.5 Million People in USOver the Age of 652 Aortic stenosis is estimatedto be prevalent in up to 7%of the population over theage of 651PercentageDiagnosed withAortic StenosisIt is more likely to affectmen than women; 80% ofadults with symptomaticaortic stenosis are male34
What Causes Aortic Stenosis in Adults?More CommonAge-Related CalcificAortic StenosisAortic stenosis in patients over the age of 65is usually caused by calcific (calcium)deposits associated with agingInfectionAortic stenosis can be caused by variousinfectionsRheumatic FeverAdults who have had rheumatic fever mayalso be at risk for aortic stenosisCongenitalAbnormalityIn some cases adults may develop aorticstenosis resulting from a congenitalabnormalityLess Common5
Major Risk FactorsIndependent clinical factorsassociated with degenerative aorticvalve disease include the following:4 Increasing age Male gender Hypertension Smoking Elevated lipoprotein A Elevated LDL cholesterol6
Symptoms of Aortic Stenosis5What are the symptoms of aortic stenosis? Angina - A sensation of aching, burning, discomfort, fullness, pain, or squeezing inthe chest. It may also be felt in the arms, back, jaw, neck, shoulders and throat Syncope- A sudden and brief loss of consciousness Shortness of breath - Feeling winded and tired when walking or lying down Dizziness (after periods of inactivity) Rapid or irregular heartbeat Palpitations – An uncomfortable awareness of the heart beating rapidly or irregularly7
Multiple Modalities May Be Used to6Diagnose Severe Aortic StenosisAuscultationTransthoracicEcho (TTE)ChestX-rayCardiacCath.Electrocardiogram8
Aortic Stenosis Is Life Threatening7and Progresses Rapidly Survival after onset of symptoms is 50% at 2 years1 and 20% at 5yrs. Surgical intervention for severe aortic stenosis should be performedpromptly once even minor symptoms occur 19
Timely intervention is critical for patients with symptoms6 In the absence of serious comorbidconditions indicated in the majority ofsymptomatic patients with severe aorticstenosis Consultation with or referral to a HeartValve Center is reasonable whendiscussing treatment options for:o Asymptomatic patients with severevalvular heart diseaseo Patients with multiple comorbiditiesfor whom valve intervention isconsidered Because of the risk of sudden death,replacing the aortic valve should beperformed promptly after the onset ofsymptoms Age is not a contraindication to surgery10
Sobering Perspective8Severe aortic stenosis has a worse prognosis than manymetastatic cancers*Using constant hazard ratio. Data on file, Edwards Lifesciences LLC. Analysis courtesy of Murat Tuczu, MD, Cleveland Clinic11
AHA/ACC guidelines for aortic valve replacement inpatients with aortic stenosis12
Options for Aortic Valve ReplacementIntermediate Risk Patients (STS 3-8%)High Risk Patients (STS 8%)Transcatheter Aortic Valve Replacement(TAVR)Low Risk Patients(STS 3%)Surgical Aortic ValveReplacement (SAVR)Minimal Incision ValveSurgery (MIVS)PARTNER Research:Continued Access forLow Risk Enrollment forTAVR13
What is in the STS score?14
TAVR is indicated for intermediate-risk patients15
PARTNER 3 Low Risk Continued Access16
History of Edwards’ transcatheter heart valvetechnology in the United States17
VIV TAVR & TMVR is an option to treat patients withfailed surgical valves in high risk patientsFor use in patients with: Symptomatic heart disease due toeither severe native calcific aorticstenosis or failure (stenosed,insufficient, or combined) ofsurgical bioprosthetic aortic ormitral valves. Evaluated by a Heart Team,including a cardiac surgeon, to be athigh or greater risk for open surgicaltherapy Ongoing trial for intermediate-lowrisk MVIV patients18
The PARTNER II Trial: Intermediate-risk cohort19
Mortality rates continue to decline20
Intermediate Risk Patients21
All-cause mortality*22
Disabling Stroke*23
24
Identifying PotentialCandidates for TAVR
Characteristics of a TAVR Patient17TAVR patients may present with some of the following:Severe, symptomatic native aortic valve stenosisOld ageHistory of stroke/CVAFrailtyHistory of syncopeReduced EFHeavily calcified aortaPrior CABGPrior chest radiationHistory of AFibPrior open chest surgeryFatigue, slow gaitPeripheral vascular diseaseHistory of CADHistory of COPDHistory of renal insufficiencyDiabetes and hypertension26
The specialized Heart TeamCohesive, multi-disciplinary approach embodies Optimal patient centric care Dedication across medical specialties Collaborative treatment decisionNational coveragedetermination28The patient (preoperativelyand postoperatively) is underthe care of a Heart rdiacsurgeonHeartTeamReferringcardiologistValve cliniccoordinatorNursingAnesthesiologist28. National coverage determination (NCD) for transcatheter aortic valve replacement (TAVR). 201227
Complete TAVR Workup Includes: Qualifying gradients (either by TTE or Cath) TAVR CT- both Heart/coronaries & Chest/abd/pelvis Coronary Angiogram Pulmonary Function Test 2 CV surgery visits28
Following Patient Referral, the TAVR Teamwill Perform Further Evaluation21Confirm thepatient isdiagnosed withseveresymptomaticnative aorticstenosisConfirm thepatient has beenevaluated by twocardiacsurgeons andmeets theindication forTAVR3Evaluate theaortic valvularcomplex usingechocardiography45Evaluate theaortic valvularcomplex andperipheralvasculatureusing CTEvaluate theaortic valvularcomplex mineaccess routefortranscatheteraortic valvereplacementNote: The above is a suggested flow for the patient screening process, however, the order in which screeningtests are conducted varies depending on the patient’s profile and should be at the discretion of the Heart Team.29
A collaborative treatment decision30
Echocardiographic Guidelines are the Gold Standardin Assessing Severe Aortic Stenosis6According to the 2008 ACC/AHA guidelines, severe aortic stenosis is defined as: Aortic valve area (AVA) less than 1.0 cm2 or index AVA 0.6cm2/m2 Mean gradient greater than 40 mmHg OR jet velocity greater than 4.0 m/s**Doppler-Echocardiographic measurements31
Paradoxical Low Flow and/or19Low Gradient Severe Aortic Stenosis Dobutamine stress echocardiographycan be used to differentiate betweentrue and pseudo severe aortic stenosis Better define the severity of the aorticstenosis Accurately assess contractile/pumpreserve Some patients with severe aorticstenosis based on valve area have alower than expected gradient (e.g. meangradient 30 mmHg) despite preservedLV ejection fraction (e.g. EF 50%) Up to 35% of patients with severe aorticstenosis present with low flow, lowgradient These low gradients often lead to anunderestimation of the severity of thedisease, so many of these patients do notundergo surgical aortic valve replacementDobutamine stress in low gradient, low ejection fraction ASChambers, Heart. 2006 April; 92(4): 554–55832
Complexities of Measuring Risk19While some patients may have low STSscores, certain conditions may precludethem from being suitable candidates forsurgery, for example:Extensively calcified (porcelain) aortaChest wall deformityChest radiationOxygen-dependent respiratoryinsufficiency Frailty Example: Porcelain aorta in TAVR candidate3/6/2019
Frailty: An Important Parameter Frailty is an important parameter in assessing operative risk Transcatheter aortic valve replacement is a best therapy for intermediate andhigh risk inoperable patients with severe aortic stenosis Prevalence of frailty increases with aging; old does not necessarily equal frail Rehab potential post procedure Elderly patients achieve measurable benefit from cardiac surgery, particularlyin terms of: Quality of life Increased survival Prevention of adverse cardiovascular events34
Assessing Appropriate Vascular AccessVessel diameters must be a minimum of: 5.5mm for a 20, 23 & 26mm valve (requires a 14F eSheath) 6.0 mm for a 29mm valve (requires a 16F eSheath)35
Clinical outcomes improves as therapy evolves36
3mensio CT report37
38
39
40
Device SelectionSelf expanding (in trial)41
Complete range of valve sizes expandsthe treatable patient population42
TAVR Conference PresentationTAVR Committee:CMS requires a multidisciplinary approach;patients are worked up andpresented to our in-houseTAVR Committee forapproval – committeeincludes cardiologists, CVsurgeons, research staff,Cath lab, OR, CCU/HFICU,HVI administration, etc.;meets weeklySlides include:Patient demographics;pertinent medical history;STS score; diagnostictesting results & anatomicalmeasurements; proposedtreatment plan43
Transcatheter Aortic Valve Replacement (TAVR)TAVR Pre-Procedure Overview
Pre-Procedure Nursing Implications Patients will be admitted to the hospital the day before theprocedure or will report to the Cath Lab/OR the morning ofthe procedure depending on facility Hibiclens scrub Patient education and discharge expectations Shaving Possibility of a Foley Catheter or Condom Catheter MD Preference MAC vs. General Anesthesia45
Pre-ProcedureInpatients should be ready for transport by 7am Labs drawn, consents obtained, anesthesia assessment done Consent should read: “Transcatheter aortic valve replacement”Procedural needs: NPO per anesthesia guidelines Current type and screen with products available Blood products are to be available in room during procedure Pre-procedure hydration to prevent kidney injury CHG bath completed Clip hair from neck to knees Arm/blood bands preferably on left arm (anesthesia uses right wrist forarterial line)46
Transcatheter Aortic Valve Replacement (TAVR)TAVR Procedure Overview
The TAVR procedure can be performed throughmultiple access approaches48
Access Sites Arterial 14Fr/16Fr Sheath for Transcatheter Valve 5Fr/6Fr Sheath Pigtail Catheter (contralateral to THV) Radial Line Venous 5Fr/6Fr Sheath Temporary Pacemaker (contralateral to THV) 5Fr/6Fr Sheath Secondary venous access (possible)49
An Alternative Option for Patients Without VascularAccess Some patients maynot have adequatevascular access toaccommodate thesheath used duringtransfemoralprocedures For these patients,alternative accessapproaches areavailable, such astransapical andtransaorticDuring the transapicalapproach, the EdwardsSAPIEN transcatheterheart valve is deliveredthrough the apex of theheart by making a smallincision between the ribsDuring the transaorticapproach, the EdwardsSAPIEN transcatheterheart valve is deliveredthrough an incision in thefront of the chest50
Trans-axillary approach51
Intra-procedure Access: Femoral (primary method),trans-aortic, trans-subclavian, transapical or trans-axillary Done under MAC anesthesia orgeneral (if necessary) Valve is advanced via the aorta (overa delivery catheter) to the aortic valve Valve is positioned and inflated with aballoon (similar to a coronary stent) Rapid pacing is performed duringballoon inflationTransfemoralTransapical This minimizes cardiac motion andprevents dislodgement of the valveduring deployment Balloon is deflated and removed Valve positioning is confirmed usingangiography and echo52
Edwards SAPIEN Transcatheter Heart ValveDeployment53
Angiogram Images54
Post-Operative Care andLength of Stay
Post-Op Nursing ImplicationsTransfemoralTwo Post-OpPathwaysTransapical,Transaortic &Trans-axillary56
Post-Op Nursing Implications Transfemoral2757
Post-Op Nursing Implications Transfemoral2758
Post-Op Nursing Implications TA and TAo2759
Post-Op Nursing Implications TA and TAo2760
How to reduce Length of Stay (LOS)Pre-procedureProcedurePost-Procedure3/6/2019 Patient evaluation and selection Set patient and family expectations Early discharge Procedural brief Perioperative Protocols Foley, MAC vs. GA, Swan-Ganz Extubation Ambulation Transfemoral and Transaortic: 4 hours Transapical: 6-8 hours Foley removal Swan-Ganz removal Discharge Communication to family, MD, NP, Charge NurseTAVR Nursing Implications
TVT Registry Info62
Common Complications Vascular issues – damage to iliac/femoral arteries – sometimes requiressurgical repair Ventricular wall perforation by wire – resulting in tamponade (may beseen after leaving the procedural area) Valvular complications - annular rupture, malpositioning, leaking aroundthe valve Arrhythmias – heart block related to AV node disruption – sometimesresolves, sometimes requires permanent pacer insertion Most patients develop a BBB during deployment – this usually resolves over a fewminutes or hours, however, some remain and ultimately require pacing intervention Temporary pacers maybe left overnight to monitor Coronary artery occlusion by TAVR valve resulting in MI Stroke Death63
Post Procedure Management Observe access site for complications Observe for signs/symptoms of stroke, MI, chest pain Observe for conduction disruptions – bradycardia, bundle branchblock, heart block Monitor hemodynamics – address hyper or hypotension Remember – these are not surgical patients – early ambulation ispreferred (within 2-4 hours) Up, out of bed, eating as soon as tolerated Begin discharge planning immediately post-procedure Consult social work/ case managment Goal for length of stay is no more than 1-2 days post-procedure Cardiac Rehab consult o64
Post Procedure Management Access sites: Primary access site is whichever side the valve delivery sheath is inserted – itcould be right or left femoral artery depending on vessel size - the valve sheath is usually 14F– for a 29mm valve it is 16F Smalling/Dhoble/Balan: Valve sheath & 7F venous (for temp pacer) to primary side; 6F arterial& 5F venous to contralateral side (opposite side) Kar/Jumean/Kumar/Loyalka: Valve sheath to primary side; 5F arterial & 7F venous (for temppacer) to contralateral side Valve sheaths & 6F arterial sheaths are closed with Proglide/Prostar – 5F arterial sheaths areclosed with Mynx Venous sheaths are closed with manual pressure Lines left in place: Radial arterial line and peripheral IV – generally these are the only lines leftin If there are AV conductions issues (bradycardia, BBB, other heart block) the temporary pacingwire will be left in place If carotid protection (Sentinel) was used, there will be a TR band to the associated radial site65
Carotid ProtectionStroke is a concern during TAVR due to calcification of aortic valve – debris can travel to thecerebral arteries during valve deployment causing strokeCerebral protection devices: (inserted during procedure and removed at end of procedure) Sentinel – 6F via radial access (FDA approved)TriGuard – 9F via femoral access (current trial in enrollment)66
Carotid Protection67
AV Conduction Delays Some patients experience new BBBor AV block due to swelling/irritationor compression around the AV node Monitor for heart block, BBB orbradycardia in the post-procedureperiod – this can be a late occurrence Avoid use of beta-blockers thatmay potentiate heart block68
Post Procedure Hypertension ManagementPatients may experience post TAVR hypertension Due to the decrease in afterload by relieving LV outflow obstruction(the heart is used to working hard, but no longer needs to) For transapical or transaortic access – keep SBP no more than 120mmHg to prevent suture line tears Commonly treated with Cardene gtt – Dr. Smalling prefers his MAPsto be 75-85 for all TAVR patients69
Post Procedure Hypotension Hyperdynamic ventricle – some patients develop an enlarged LV withdiastolic dysfunction due to chronic high afterload Rapid relief of the obstruction results in severe hypotension/shock –dubbed “suicide ventricle” Generally have small LV cavity, enlarged septum and high EF( 70%) – “little old ladies” are particularly at risk LV is unable to fill adequately (preload), decreasing CO; tachycardiadecreases LV filling time even more, creating a downward spiral Use of Dopamine, Epi, Norepi increases contractility & heart rateeven more – this makes it worse! Treatment involves decreasing contractility using beta-blockers andensuring adequate preload by increasing volume Beta-blockers & Volume70
Resources
Resources Available for You and Your Patients Resources for healthcareproviders to accessinformation about aorticstenosis and TAVR Patients can learn aboutthe disease and locate alocal TAVR Center Symptom checklist to helppatients discuss theirtreatment options withtheir healthcare provider3/6/2019TAVR Nursing Implications
9,000 people clicked on the Symptom Checklist& Doctor Discussion Guide3/6/2019TAVR Nursing Implications
NewHeartValve.com Resource Library Severe Aortic Stenosis BrochurePatient BrochureTAVR Patient Screening Fact SheetPatient Screening SupplementHeart TabletsSAS KitSAS PosterTF & TA PostersSAS Brochure StandRubber Valve Display Stands3/6/2019TAVR Nursing Implications
Edwards Heart Master Apps on iTunes Educational Resource that can be used to helpeducate patients Dedicated to AS with 3D immersion in heart anatomyand pathophysiology Free iPad and iPhone Apps3/6/2019TAVR Nursing Implications
Questions?3/6/2019TAVR Nursing Implications
References1.Otto CM. Timing of aortic valve surgery. Heart. 2000;84:211-21.2.Census.gov – 2010 US Census Report.3.Ramaraj R, Sorrell VL. Degenerative aortic stenosis. Br Med J 2008;336: 550–5.4.Stewart BF, Siscovick D, Lind BK, et al. Clinical factors associated with calcific aortic valve disease. Cardiovascular Health Study. J Am Coll Cardiol.1997;29:630-634.5.Mayo Clinic Staff; September 22, 2011: www.mayoclinic.com - osis/DS00418/DSECTION symptoms.6.ACC/AHA 2006 Guidelines for the Management of Patients With Valvular Heart Disease: A Report of the ACC/AHA Task Force on Practice Guidelines(Writing Committee to Revise the 1998 Guidelines for the Management of Patients With Valvular Heart Disease) DOI:10.1161/CIRCULATIONAHA.108.190748 Circulation published online Sep 26, 2008.7.Lester SJ, Heilbron B, Dodek A, Gin K, Jue J. The Natural History And Rate Of Progression Of Aortic Stenosis CHEST 1998;113(4):1109-1114.8.National Institutes of Health. National Cancer Institute. Surveillance Epidemiology and End Results. Cancer Stat Fact Sheets.http://seer.cancer.gov/statfacts/. Accessed November 16, 2010.9.Bouma BJ, Van Den Brink RB, Van Der Meulen JH, et al. To operate or not on elderly patients with aortic stenosis: the decision and its consequences.Heart. 1999;82:143-148.10. Pellikka PA, Sarano ME, Nishimura RA, et al. Outcome of 622 adults with asymptomatic, hemodynamically significant aortic stenosis during prolongedfollow-up. Circulation. 2005;111:3290-3295.11. Charlson E, Legedza AT, Hamel MB. Decision-making and outcomes in severe symptomatic aortic stenosis. J Heart Valve Dis. 2006;15:312-32112. Varadarajan P, Kapoor N, Banscal RC, Pai RG. Clinical profile and natural history of 453 nonsurgically managed patients with severe aorticAnn Thorac Surg. 2006;82:2111-2115.stenosis.13. Jan F, Andreev M, Mori N, Janosik B, Sagar K. Unoperated patients with severe symptomatic aortic stenosis. Circulation. 2009;120;S753.14. Bach DS, Siao D, Girard SE, et al. Evaluation of patients with severe symptomatic aortic stenosis who do not undergo aortic valve replacement: thepotential role of subjectively overestimated operative risk. Circ Cardiovasc Qual Outcomes. 2009;2:533-539.15. Freed BH, Sugeng L, Furlong K, et al. Reasons for nonadherence to guidelines for aortic valve replacement in patients with severe aortic stenosis andpotential solutions. Am J Cardiol. 2010;105:1339-1342.(Continues on next page)68
References (Continued)(Continued from previous page)16. Brown ML, Pellikka PA, Schaff HV, et al. The benefits of early valve replacement in asymptomatic patients with severe aortic stenosis. J ThoracCardiovasc Surg. 2008;2:308-315.17. Leon M, Smith C, Mack M, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. New England Journalof Medicine 2010 October 21;363(17):1597-1607.18. Smith, C. et. al. Transcatheter versus Surgical Aortic-Valve replacement in High-Risk Patients. N Engl J Med. 2011;364(23): 2187-219819. Dumesnil et al, Paradoxical low flow and/or low gradient severe aortic stenosis despite preserved left ventricular ejection fraction: implications for diagnosisand treatment European Heart Journal 2010; 31, 281-289.20. Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A: A global clinical measure of fitness and frailty in elderly people.CMAJ 2005, 173:489-495.21. Columbia Frailty Index, adapted from Fried, J Gerontol Med Sci 2001.22. Reynolds MR, et al. Cost Effectiveness of Transcatheter Aortic Valve Replacement Compared with Standard Care Among Inoperable Patients with SevereAortic Stenosis: Results from The PARTNER Trial (Cohort B). Circulation 2012; 125:1102-1109.23. Outcomes Following Transcatheter Aortic Valve Replacement in the United States , Mack MJ, et al. JAMA 2013;310(19):2069-2077. November, 2013.24 .D. Holmes, MD. (March 2014). One Year Outcomes from the STS/ACC Transcatheter Valve Therapy (TVT) Registry. Presentation conducted at ACC2014, Washington, D.C.25. Cardiovascular Outcomes Inc. KCCQ Overview. September 21, 2008. http://cvoutcomes.org/pages/321426. Spertus J, Peterson E, Conrad MW, et al. Monitoring clinical changes in patients with heart failure: a comparison of methods. Am Heart J. 2005;150:707715.27. Cath Lab Digest. Reducing Length of Stay and Enhancing Clinical Outcomes for TAVR Patients with a Focused Clinical Pathway. Available -Patients-Focused-Clinical-Path. Accessibilityverified May 22, 2014.28. National coverage determination (NCD) for transcatheter aortic valve replacement (TAVR). 201270
front of the chest . 51 Trans-axillary approach . Access: Femoral (primary method), trans-aortic, trans-subclavian, trans-apical or trans-axillary Done under MAC anesthesia or general (if necessary) Valve is advanced via
TAVR: Overview of the Application Overview: CT Transcatheter Aortic Valve Replacement (TAVR) planning assists with the assessment of the aortic valve and in pre-operational planning and post-operative evaluation of tr
Life After TAVR . During your recovery, there are important steps that you—and your caregiver—can take . to help you recover and return to your daily routine more smoothly. This section will help you through many of those steps, and it will address some of the concerns and questions you may have about life after TAVR, including the .
Pre, Post And Intra Procedure 2017 ASE Florida, Orlando, FL October 10, 2017 8:00 -8:25 AM 25 min Disclosures Speakers Bureau (Philips, Medtronic) Advisory Board (Siemens) 10/10/2017 2 PRIMARY INDICATIONS FOR SURGICAL OR PERCUTANEOUS TREATMENT OF AORTIC STENOSIS SEVERE Aortic Stenosis SYMPTOMS
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The facts and extensive procedural history of Albert Woodfox’s case have been recounted time and again, but they bear repeatingsince they factored into theunconditional writ granted by the district court On April 17, 1972, . Correctional Officer Brent Millerof the Louisiana State Penitentiary in , Angola, Louisiana, was found murderedin the prison dormitory , havingbeen stabbed 32 times. The .
