CARDIAC RESYNCHRONIZATION THERAPY Jeffrey J. Shultz, MD Cardiac Electrophysiology Park Nicollet Heart and Vascular Center

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<p>Cardiac Resynchronization Therapy</p> <p>Cardiac Resynchronization TherapyJeffrey J. Shultz, MDCardiac ElectrophysiologyPark Nicollet Heart and Vascular CenterCase: DK 69 y/o male2006 - Aortic valve replacement and CABG. (No h/o MI)LVEF remained approximately 45%LBBB (ECG to be shown)NYHA Class ICarvedilol 25 mg BID, Lisinopril 20 mg daily, HCTZ, Coumadin, ASA, Amlodipine, Lipitor2014 Episodic dyspnea, LVEF down to 35%Lasix and spironolactone addedJan 2015 - Progressive DOE, NYHA Class III, Stress test = inferior ischemia and LVEF=20%Feb 2015 Cor Angio = non-occlusive CAD. Rx = Med Mgmt.June 2015 Remains NYHA Class III, LVEF=30%, Referred for Bi-V ICD</p> <p>DK 69 y/o male</p> <p>Congestive Heart Failure - Magnitude of the ProblemEstimated 5.1 million in US / 23 million worldwide (2006)Exact numbers difficult due to varying inclusion criteriaSteep rise in incidence with age3-4-fold increase in hospitalizations from 1971-1999Increase in Mortality attributable to CHF from 5.8/1000 in 1970 to 16.4/1000 in 1993$32 billion spent on treatment of CHF in US / yearDeatHs due to coronary heart disease</p> <p>NHLBI 2012Hospitalizations due to CHF</p> <p>NHLBI 2012Age-related CHF Incidence(#/1000)</p> <p>leMaleFemaleBleumink, et.al. EHJ 2004</p> <p>1. Framingham Heart Study (1948 1988) in Atlas of Heart Diseases.2. American Heart Association. Heart Disease and Stroke Statistics2003 Update. </p> <p>Systolic versus Diastolic CHFSystolic HF-REFImpaired contractility / ejectionLVEF 50%Approximately 1/3 CHF prevalenceCommon conditions HTN, elderly without HF-PEF, HCM, constrictive/ restrictive CMLimited therapeutic options</p> <p>HF-pef vs hf-ref mortality</p> <p>Brouwers et.al, EHJ 2013</p> <p>1. The Criteria Committee of the New York Heart Association. Nomenclature and Criteria for Diagnosis of Diseases of the Heart and Great Vessels. 9th ed. Boston, Mass: Little, Brown &amp; Co; 1994:253-256</p> <p>Weapons against Systolic CHFPrevention Education and management of CAD risk factorsAggressive treatment of UA/STEMI/Non-STEMIMedical therapy ACE-Is/ARBs, -blockers, aldosterone antagonists, diureticsDietary / Fluid restrictionsAggressive outpatient monitoring programsCardiac Resynchronization Therapy (CRT)What is Dyssynchony?3 types of dyssynchronyAV Delay between atrial and ventricular contraction (AV block)Interventricular Delay between right and left ventricular activation (LBBB)Intraventricular - normal ventricular activation sequence is disrupted, resulting in discoordinated contraction of the LV segmentsCRT can help with all threeLeft Bundle Branch Block- Currently best measure of left ventricular dyssynchrony- QRS duration &gt; 120; preferably &gt; 150 for CRT</p> <p>HOW DO WE MEASURE DYSSYNCHRONY?CRT DevicesCRT-D Implantable Defibrillator capable of Bi-Ventricular Pacing (Most common)CDT-P Pacemaker capable of Bi-Ventricular Pacing (Has no ability to treat ventricular tachyarrhythmias)</p> <p>Coronary venous anatomy</p> <p>Pressure Products CSG Worley Sheath</p> <p>Coronary venous anatomy</p> <p>LV lead placement</p> <p>Dong et.al; Europace 2012</p> <p>CRT Indications - 2012Class 1 - LVEF less than or equal to 35%, sinus rhythm, LBBB with a QRS duration greater than or equal to 150 ms, and NYHA class II, III, or ambulatory IV symptoms on GDMT.Class 2a LVEF less than or equal to 35%, sinus rhythm, LBBB with a QRS duration 120 to 149 ms, and NYHA class II, III, or ambulatory IV symptoms on GDMT.LVEF less than or equal to 35%, sinus rhythm, a non-LBBB pattern with a QRS duration greater than or equal to 150 ms, and NYHA class III/ambulatory class IV symptoms on GDMT.Atrial fibrillation and LVEF less than or equal to 35% on GDMT if a) the patient requires ventricular pacing or otherwise meets CRT criteria and b) AV nodal ablation or pharmacologic rate control will allow near 100% ventricular pacing with CRTPatients on GDMT who have LVEF less than or equal to 35% and are undergoing new or replacement device placement with anticipated requirement for significant (&gt;40%) ventricular pacing.</p> <p>CRT Indications - 2012Class 2bLVEF less than or equal to 30%, ischemic etiology of heart failure, sinus rhythm, LBBB with a QRS duration of greater than or equal to 150 ms, and NYHA class I symptoms on GDMTLVEF less than or equal to 35%, sinus rhythm, a non-LBBB pattern with QRS duration 120 to 149 ms, and NYHA class III/ambulatory class IV on GDMTLVEF less than or equal to 35%, sinus rhythm, a non-LBBB pattern with a QRS duration greater than or equal to 150 ms, and NYHA class II symptoms on GDMTClass 3NYHA class I or II symptoms and non-LBBB pattern with QRS duration less than 150 msComorbidities and/or frailty limit survival with good functional capacity to less than 1 year.</p> <p>REVERSE and RAFT (2012)REVERSE (REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction) and RAFT (Resynchronization/Defibrillation in Ambulatory Heart Failure) trials showed that Cardiac Resynchronization Therapy (CRT-D) reduced Heart Failure (HF) Hospitalization or All-Cause Death. Looked at patients with;NYHA Class IILeft Bundle Branch BlockLeft Ventricular Ejection Fraction 30% QRS duration 130 ms </p> <p>REVerse and raft - results REVERSE: Reduction of Worsened Clinical Composite Responsefrom 18% with CRT OFF versus 5% with CRT ON (p = 0.004) (Figure 1) REVERSE: 73% reduction in Time to First HF Hospitalization or All-Cause Death with CRT (p = 0.004) (Figure 2) RAFT: 42% reduction in Time to First HF Hospitalization or All-Cause Death with CRT-D (p &lt; 0.0001) </p> <p>Reverse - results</p> <p>Expanded CRT indications with reverse and raft31NYHA III/IV**NYHA IIQRS DurationProlongedLBBB***, QRS 130 msLVEF 35% 30%Optimal Medical TherapyYesYesApproved Device(s)CRT-P, CRT-DCRT-D onlyIn this slide, the one column shows the FDA-approved labeling that Medtronic (and other manufacturers) received for NYHA Functional Class III and Ambulatory Class IV patients. In comparison, the FDA-approved labeling for Medtronic CRT-D devices in the NYHA Class II patients requires a left bundle branch block, a QRS duration of greater than or equal to 130 ms, an ejection fraction of less than or equal to 30%, and optimal medical therapy. Note that the labeling is only for CRT-D and not CRT-P.</p> <p> 31Block HF trial 2013Objective: To determine if biventricular pacing with CRT is superior to right ventricular only pacing in patients with;Class I or IIa pacing indicationNYHA class I, II, or IIILVEF 300 msec with pacing at 100 BPMBlock hf - results</p> <p>Updated recommendations - April 2014</p> <p>AV block (prolonged 1st degree, 2nd or 3rd degree)NYHA Class I, II, III heart failureLVEF 50%Optimal medical therapy (OMT)DK 68 y/o maleUnder went implant of CRT-D on 6/17/15ECG to be shownSaw PMD on 7/21/15 Feel great! No dyspnea or DOE.Seen in Cardiology 9/2/15 NYHA Class I-IIEcho LVEF = 30% but LV chamber size noted to be smallerDK 69 y/o male</p> <p>DK 68 y/o male post CRT-D</p> <p>CRT RespondersApproximately 70% response rate30-40% will have objective improvement in LVEFCharacteristics of respondersLBBB with QRS duration &gt; 150 msecQRS to LV pacing site &gt; 110 msec100% LV pacingCommon causes for being a non-responderReduced LV pacing lead dislodgement, atrial fibrillation, PVCsPoor LV lead position anatomy, lead dislodgementProgramming issues suboptimal AV delay or V-V timing</p> <p>Potential Implant ComplicationsBleeding / hematoma / bruisingInfectionCardiac perforationPneumothoraxLead dislodgementDiaphragm / Phrenic Nerve stimulationVenous thrombosisVascular injuryBrachial plexus injuryRenal failureArrhythmia inductionCVA / MI / DeathPhrenic Nerve Stimulation</p> <p>Post-Op carePain reliefMonitor typical post-op vital signsMonitor wound intact, no bleeding, limited swelling at site or armMonitor for pneumothorax / pericardial effusion / tampanade sudden chest pain, dyspnea, hypotension, neck vein distentionWatch for loss of capture / change in pacing complex / over- and undersensingMonitor for Diaphragm pacingConclusionsCHF remains a major clinical problem and is responsible for significant CV mortality and repeat hospitalizationsCRT has proven to be a significant adjunct to CHF medical therapy resulting in improved in survival and decreased hospitalizationsCRT can be performed with high rate of success and low rate of complicationsApprox 70% will respond to CRT and LVEF will improve in approx 30-40%.Looking for better ways to identify dyssynchrony and target dyssynchronyLV lead positioning limited by anatomy, scar, diaphragm pacing</p>