2/23/2017
Structural Heart Disease: Setting the Stage for Success
Brenda McCulloch, RN MSN RCIS Cardiovascular Clinical Nurse Specialist, Interventional & Medical Cardiology Sutter Medical Center, Sacramento
Learning Objectives
To date 1. Define the scope of structural heart disease. 460+ TAVRS 2. Adapt principles of program development when developing your structural heart services. 45+ MitraClip 3. Differentiate between various procedures done for 12+ Watchman structural heart disease. In 2016 – 3,600+ coronary & peripheral procedures – 1,000+ electrophysiology procedures – 800 open heart surgeries – 32 VAD implants
1 2/23/2017
What is Structural Heart Disease (SHD)? Scope of Structural Heart Disease
• Describes non-coronary artery disease procedures & • Valvular heart disease treatments treatment • Emerging within cardiovascular medicine as its own sub- • Paravalvular leak repair specialty • Left atrial appendage • More medical training programs are adding an additional closure year to interventional cardiology fellowship for SHD experience • Hypertrophic cardiomyopathy treatment • Will continue to evolve with emerging technology & our aging population • Program development & on-going support is essential for Steinberg et al, 2010 sustained success & growth
Keys to a Successful Program Planning
• Name a single point of contact • Planning • Identify key stakeholders • Executing • Develop steering committee • Outline communication plan • Monitoring • Determine anticipated patient flow • Evaluating • Define education plan • Complete a gap analysis • Revising
2 2/23/2017
Our Heart Team in Action
In 2012, our HEART TEAM started with 2 interventional cardiologists, 2 CV surgeons, 1 imaging cardiologist, 2 anesthesiologists, a CNS, & representatives from Perfusion, Cath Lab, CVOR, & ICU/tele.
Executing Monitoring
• Communicate often with the team • Follow patient outcomes closely • Practice ‘dry runs’ & worst case scenarios • Communicate with referral base • Debrief each case, share learnings with the entire team • Participate in registries, research • Implement rapid cycle tests of change • Assess impact on other services, procedures • Develop specific quality indicators to monitor • Evaluate impact on ICU beds, tele beds, hospital throughput • Market to your referral base • Review costs, billing, revenue, FTE utilization
3 2/23/2017
Evaluating & Revising
• Evaluate patient outcomes critically • Reassess processes & streamline when possible • Continue debriefs, rapid cycle tests of change • Re-evaluate program when adding new staff/new procedures • Consider consider LEAN/Six Sigma techniques REVIEW OF PROCEDURES
Who’s a Candidate for TAVR? Treating Aortic Stenosis (AS) Transcatheter Aortic Valve Replacement
• Most common acquired valvular disorder, increasing with • Severe AS: aortic valve area less aging population than 0.8 cm2 with peak gradient ≥ 40 mmHg • Leads to chest pain, syncope, heart failure, death • Reasonable life expectancy • 1st USA device for interventional treatment of AS - FDA approved 2011 • Increased surgical risk due to co-morbidities • Indicated for high-risk surgical candidates; increasingly being done for moderate-intermediate risk patients • Anatomy amenable to valve placement
• Femoral approach most common • Poor outcomes more common in patients with wheelchair dependency, prior open heart surgery, oxygen dependency, • General anesthesia still commonly used, typical LOS 3-4 days low serum albumin, high STS risk score
Harjai et al Harjai et al
4 2/23/2017
TAVR Procedural Complications
• Paravalvular Leak (acute aortic insufficiency) • Heart block & arrhythmias • Vascular bleeding/injury • Stroke • Acute kidney injury • Uncommon complications: device embolization/ thrombus, annular rupture, aortic dissection, ventricular perforation/rupture, acute MI, conversion to open heart surgery, death
Percutaneous aortic valves: (A) Edwards-Sapien (Edwards Lifesciences, CA, USA). (B) Fluoroscopic image of Edwards-Sapien device in place. (C) Corevalve (Medtronic- Harjai et al Corevalve, MN, USA). (D) Aortogram with CoreValve in place.
5 2/23/2017
Treating Mitral Regurgitation (MR)
• Common valvular lesion • Leads to heart failure, pulmonary hypertension, AF, stroke, death • MitraClip – approved for treatment of functional MR • Requires transseptal approach, typically done with general anesthesia, TEE imaging
6 2/23/2017
Transseptal Approach Who’s a Candidate for MitraClip?
• Increasingly done with complex • Sever MR - 3-4+ arrhythmia ablation & structural heart disease procedures. • Failing maximal medical therapy for heart failure • Needed for access to the left heart • Reasonable life expectancy • Required for mitral valve • Prohibitive surgical risk due to co-morbidities procedures, left atrial appendage closure • Anatomically amenable to clip placement • Risks include puncture of aorta, perforation of atrium, stroke Rogers et al
MitraClip Procedural Complications Paravalvular Leak (PVL) Repair
• Uncommon complication of valve replacement surgery • Access site bleeding, need for blood transfusions • Signs & symptoms of significant leak may include heart • Device embolization or partial clip deployment failure, hemolysis • Longer term complications may include mitral stenosis, • Reserved for symptomatic high-risk patients with suitable infective endocarditis anatomy • Percutaneous approach often preferred to prevent re- operation as surgical re-intervention is associated with high morbidity & mortality
Rogers et al
Lasala et al
7 2/23/2017
PVL Repair Left Atrial Appendage (LAA) Closure
• Atrial fibrillation (AF) increases • Multiple devices available for use – occluders, plugs risk of embolic stroke • Technically challenging procedure; careful imaging is • Most emboli (90%) originate important – cardiac CT, 3D TEE, intracardiac from the LAA. echocardiography (ICE) • Device closure may be beneficial for patients with chronic AF who are unable to take anticoagulation.
Left atrial appendage occluders: (A) Watchman (Atritech, MN, USA). (B). Amplatzer APC (AGA Medical, MN, USA).
Lasala et al Beigel et al
Hypertrophic Cardiomyopathy Treating Hypertrophic Cardiomyopathy Alcohol Septal Ablation
• Marked hypertrophy of the septum • 96% ethanol introduced into a septal branch of the left • Genetic autosomal-dominant disease anterior descending artery • Occurs in 1 in 500 people; 600,000 people affected in • Ablates the artery, induces infarction with stunning & the US remodeling
• Increase risk of arrhythmias, sudden cardiac death, Advantages Disadvantages angina, syncope & heart failure • Does not require open • Produces large infarct with potential • Treatment options include medical therapy, dual heart surgery &/or cardio- for arrhythmia/heart block chamber cardiac pacing, surgical ventricular myotomy- pulmonary bypass • May require repeated intervention myomectomy, alcohol septal ablation • Shorter LOS • In-hospital mortality 4% • Need for permanent pacemaker 5- 33%
Gersh et al Gersh et al
8 2/23/2017
Septal Ablation
IDEAS FROM SMCS
Lasala et al
Infrastructure Needs Determine Patient Flow
• Clinic space for patient evaluation • Access to high quality imaging: 3D echo, cardiac Typical flow for closures, Watchman procedures CT/CTA
• Hybrid cath lab/CVOR – large physical space, surgical Cath Lab PACU/HCHA Telemetry air exchanges, high quality imaging equipment with Admitted day of procedure 1-2 hour monitoring Discharged home next day integrated imaging (CT/echo) systems, multiple large display monitors Typical flow for TAVRs, MitraClip, & PVL repair procedures • Large inventory of disposables: many new sheaths, catheters, wires, devices Cath Lab CICU Telemetry • PACU & ICU accustomed to caring for CV surgical Admitted day of procedure 6-36 hours Discharged home by day 4 patients
9 2/23/2017
Staff Education Marketing to Your Referral Base
PDSA example average TAVR ICU LOS in hours In Closing
Goal: Decrease ICU length of stay About 50% decrease over 3 years • Program strength & growth aided by thoughtful planning, What did we do? careful execution, close monitoring of outcomes & costs, 1. Moved from surgical cutdown to percutaneous approach; vascular effective evaluating, & on-going revisions 60 closure devices used 50 2. Moved away from transapical approach • Interventional management of structural heart disease 40 will continue to develop as technology improves & hours 3. No Swan, no foley, lighter anesthesia, 30 more procedural sedation transforms 20 4. All lines pulled 2 - 4 hours after ICU arrival if patient hemodynamically stable • Emerging areas for future growth include mitral & 10 without pressors/pacing tricuspid valves replacement/repair, valve-in-valve, 0 5. 1st & 2nd patients of the day transferred 2013 2014 2015 2016 to telemetry 6 – 8 hours after ICU arrival stroke prevention procedures when criteria met
SMCS 2016 Total LOS = 2.6 days
10 2/23/2017
References Beigel R et al. The left atrial appendage: Anatomy, function, and noninvasive evaluation. JACC: Cardiovascular Imaging 7(12), 1251-65. Gersh BJ et al. 2011 ACCF/AHA guideline for the diagnosis and treatment of hypertrophic cardiomyopathy: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Journal of the American College of Cardiology; 58:e212– 60. Gooley R et al. Transcatheter aortic valve implantation – yesterday, today, and tomorrow. Heart, Lung and Circulation 24:1149-61. Harjai KJ et al. Transcatheter aortic valve replacement: 2015 in review. Journal of Interventional Cardiology 29(1), 27-46. Lasala JM et al. Interventional procedures for adult structural heart disease. Elsevier, 2014. Rogers, JH et al. Percutaneous edge-to-edge MitraClip therapy in the management of mitral regurgitation. European Heart Journal 32;2350-57. Otto CM et al. 2017 ACC Expert Consensus Decision Pathway for Transcatheter Aortic Valve Replacement in the Management of Adults with Aortic Stenosis, Journal of the American College of Cardiology, doi:10.1016/j.jacc.2016.12.006. Patel SM et al. Building an efficient TAVR program. Cardiac Interventions Today Nov/Dec 2016, 11-16. Poulin MF et al. Building a structural heart practice. Cardiac Interventions Today July/Aug 2014, 66-72. Steinberg DH et al. Defining structural heart disease in the adult patient: Current scope, inherent challenges and future directions. European Heart Journal Supplements 2010, E2-E9. Zaman S et al. Pre-transcatheter aortic valve implantation workup in the cardiac catheterization laboratory. Heart, Lung and Circulation 24:1162-70.
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