Upgrade to Resynchronization Therapy Upgrade.pdf · Wilkoff BL, et al. Dual-chamber pacing or...

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Upgrade to Resynchronization Therapy Saeed Oraii MD, Cardiologist Interventional Electrophysiologist Tehran Arrhythmia Clinic May 2016

Transcript of Upgrade to Resynchronization Therapy Upgrade.pdf · Wilkoff BL, et al. Dual-chamber pacing or...

  • Upgrade

    to

    Resynchronization

    Therapy

    Saeed Oraii MD, Cardiologist

    Interventional Electrophysiologist

    Tehran Arrhythmia Clinic

    May 2016

  • CRT

    • Cardiac resynchronization therapy (CRT) is an

    established therapy for patients with

    cardiomyopathy, ventricular dyssynchrony,

    and moderate-to-severe heart failure (HF)

    despite appropriate pharmacologic therapy.

    • Randomized clinical

    trials have demonstrated

    the efficacy of CRT in

    this patient population.70%

    75%

    80%

    85%

    90%

    95%

    100%

    0 1 2 3 4 5 6

    Months After Randomization

    Eve

    nt F

    ree

    Su

    rviv

    al (%

    )

    CRT

    ControlP = 0.033

    Relative risk = 0.60;

    95% CI (0.37, 0.96)

  • Pacing Induced Dyssynchrony

    • Extremely wide QRS complexes are frequently

    observed in patients who are chronically paced

    via a right ventricular (RV) lead for

    bradycardic indications.

  • Pacing in ICD Patients

    • Retrospective analyses suggest that 15–50% of

    ICD patients have an accepted indication for

    dual chamber pacing at the time of ICD system

    implantation.

    • Indications for dual chamber pacing may arise

    later in a significant portion of ICD patients

    who do not require pacing at implantation.

    Geelen P, et al. The value of DDD pacing in patients with an implantable cardioverter defibrillator. PACE 1997; 20:177–181.

    Higgins SL, et al. Indications for implantation of a dual-chamber pacemaker combined with an implantable cardioverter-

    defibrillator. Am J Cardiol 1998; 81:1360–1362.

  • Adverse Effects of RV Pacing

    • Multiple trials have shown that RV pacing may

    be associated with worsening of HF, even when

    used in conjunction with physiologic (dual-

    chamber) pacing modes.

    • This is mostly attributed to

    dyssynchrony imposed on

    ventricular function by RV

    apical pacing.

    Wilkoff BL, et al. Dual-chamber pacing or ventricular backup pacing in patients with an implantable defibrillator: The Dual

    Chamber and VVI Implantable Defibrillator (DAVID) Trial. JAMA 2002;288:3115-3123.

    Sweeney MO, et al. Adverse effect of ventricular pacing on heart failure and atrial fibrillation among patients with normal baseline

    QRS duration in a clinical trial of pacemaker therapy for sinus node dysfunction. Circulation 2003;107:2932-2937.

  • Risk of Heart Failure

    • The MOST study, reported a

  • Possible Mechanisms

    • The altered pattern of activation may lead to

    several histological and functional adjustments

    of the left ventricle, including:

    – Inhomogeneous thickening of the ventricular

    myocardium

    – Myofibrillar disarray, Fibrosis

    – Disturbances in ion-handling protein expression

    – Myocardial perfusion defects

    – Alterations in sympathetic tone and

    – Mitral regurgitation (MR)

    Polychronis Dilaveris. Upgrade to biventricular pacing in patients with pacing-induced heart failure: can resynchronization do the

    trick? Europace (2006) 8, 352–357.

  • Dyssynchrony

    • RV pacing results in interventricular

    dyssynchrony, leading to a 30–180 ms. delay

    in LV activation.

    • Intraventricular dyssynchrony

    also results from the complete

    reversion of ventricular

    activation sequence (apex to

    base instead of base to apex).

    Vassalo J, et al. Left ventricular endocardial activation during right ventricular pacing: effect of underlying heart disease. J Am

    Coll Cardiol 1986;7:1228–33.

  • Pathophysiology

    • RV apical pacing leads to a heterogeneous

    distribution of workload:

    – Lower strain (workload), in the early-activated

    region than in the late-activated regions

    • Early-activated regions tend to become thinner

    over time, as opposed to late-activated ones,

    which show a progressive increase in wall-

    thickness.

    Prinzen FW, et al. Asymmetric thickness of the left ventricular wall resulting from asynchronous electric activation study in dogs

    with ventricular pacing and in patients with left bundle branch block. Am Heart J 1995;130:1045–53.

  • Pathophysiology

    • The regional heterogeneity of myocardial

    hypertrophy results in remodeling of the LV,

    which alters its contractile and hemodynamic

    efficiency.

    • The primary causative factor of this

    remodeling seems to be the alteration of force

    vectors, which entails an alteration of

    mechanical stress distribution in the ventricle.

    • A role of a neuro-endocrine mechanisms

    cannot be excluded.

  • Mechanism of MR

    • There appears to be a complex mechanism:

    – The altered sequence of activation of the

    components of the mitral apparatus and the

    dyssynchronized transfer of forces from the

    papillary muscles through the chordae tendinae to

    the mitral leaflets lead to poor coaptation and thus

    to regurgitation during ventricular systole.

    – The appearance or aggravation of

    pre-existing MR may contribute to

    the development or deterioration of

    HF in paced patients.

  • Alternative Pacing Sites

    • There are reports of preservation of LV

    systolic function with RV septal pacing as

    opposed to RV apical pacing in patients

    without HF.

    • This was not confirmed by studies in the

    failing heart.

    Karpawich PP, Mital S. Comparative left ventricular function following atrial, septal, and apical single chamber heart pacing in the

    young. Pacing Clin Electrophysiol 1997;20:1983–8.

    Gold MR, et al. The acute hemodynamic effects of right ventricular septal pacing in patients with congestive heart failure

    secondary to ischemic or idiopathic dilated cardiomyopathy. Am J Cardiol 1997;79:679–81.

  • RV Septal Pacing

    • It has been shown that implanting the pacing

    lead at the site of the RV septal surface

    causing the shortest paced QRS may result in

    improved LV systolic performance.

    • However, the latter findings were relatively

    minor and unlikely to have any significant

    clinical impact as in the effects on LV ejection

    fraction.

    Schwaab B, et al. Septal lead implantation for the reduction of paced QRS duration using passive-fixation leads. Pacing Clin

    Electrophysiol 2001;24:28–33.

  • RVOT Pacing

    • The RV outflow tract was also proposed as an

    alternative site of RV pacing, associated with

    increased cardiac output when compared with

    RV apical pacing in acute pacing studies.

    • This was not confirmed

    conclusively either with

    long-term pacing studies.

    De Cock CC, et al. Hemodynamic benefits of right ventricular outflow tract pacing: Comparison with right ventricular apex pacing.

    Pacing Clin Electrophysiol. 1998;21:536–41.

    Victor F, et al. Optimal right ventricular pacing site in chronically implanted patients: a prospective randomized crossover

    comparison of apical and outflow tract pacing. J Am Coll Cardiol 1999;33:311–6.

  • CRT

    • LV or biventricular (BiV) pacing has been

    proposed as an adjunctive treatment for

    patients with advanced HF complicated by RV

    pacing induced discoordinate contraction.

    • Both short-term and a growing number of

    long-term clinical trials have reported on the

    mechanisms and short- and mid-term efficacy

    of this approach, with encouraging results.

    Mehra MR, Greenberg BH. Cardiac resynchronization therapy: caveat medicus! J Am Coll Cardiol 2004;43:1145–8.

  • Pacing QRS Duration

    • A QRS duration over 200 ms has been

    arbitrarily proposed to suggest the upgrade of

    RV pacing in HF patients to BiV pacing.

    • Such a wide QRS has been suggested to

    correspond with notable inter- or intra-LV

    mechanical dyssynchrony.

    Bordachar P, et al. Interventricular and intra-left ventricular electromechanical delays in right ventricular paced patients with heart

    failure: implications for upgrading to biventricular stimulation. Heart 2003;89:1401–5.

  • Pacing QRS Duration

    • It should be noted, however, that improved

    mechanical synchrony and function do not

    necessarily require increased electrical

    synchrony.

    • More recent data dispute the correlation

    between electrical features (QRS duration) and

    the degree of electromechanical ventricular

    dyssynchrony in RV paced patients.

    Leclercq C, et al. Systolic improvement and mechanical resynchronization does not require electrical synchrony in the dilated

    failing heart with left bundle-branch block. Circulation 2002;106:1760–3.

  • Intraventricular Dyssynchrony

    • RV pacing-induced intraventricular

    dyssynchrony is more common than

    interventricular dyssynchrony.

    • The major cause of LV function impairment is

    likely to be the presence of intra-LV

    dyssynchrony.

    Auricchio A, et al. Effect of pacing chamber and atrioventricular delay on acute systolic function of paced patients with

    congestive heart failure. The Pacing Therapies for Congestive Heart Failure Study Group. The Guidant Congestive Heart Failure

    Research Group. Circulation 1999;99:2993–3001.

  • Echocardiographic Dyssynchrony

    • Echo documented

    dyssynchrony is an

    approach to patient

    selection and gives

    new insight into the

    possible mechanisms

    of improvement.

  • Intra-ventricular Dyssynchrony

    • BiV pacing results in the improvement of intra-

    LV rather than of interventricular synchrony.

    • RV-paced patients who present with an

    abnormally increased intra-LV dyssynchrony

    should benefit more from BiV upgrading

  • CRT Upgrade Studies

    • Five studies compared the clinical outcomes of

    patients who received an upgrade to CRT with

    those who received a de novo CRT implant.

    • During a follow-up of 3–38 months, upgraded

    patients showed improvement similar to the de

    novo patients.

    2013 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy

  • The RAFT Upgrade Substudy

    • The success rate was 95.2% for de novo versus

    96.3% for study upgrade and 90.0% for substudy

    CRT attempts (upgrade within 6 months after

    presentation of study results).

    Vidal Essebag et al. Incidence, Predictors, and Procedural Results of Upgrade to Resynchronization Therapy. The RAFT Upgrade Substudy.

    Circ Arrhythm Electrophysiol. 2015;8:152-158.

  • The Rate of CRT Upgrade

    • This varies widely among studies.

    • In a retrospective single center study, the

    upgrade rates at 1, 3, and 5 years were 0.03%,

    2.4%, and 5.1%, respectively.

    Scott P A et al. Rates of Upgrade of ICD Recipients to CRT in Clinical Practice and the Potential Impact of the More Liberal Use of CRT at

    Initial Implant. Pacing and Clinical Electrophysiology Volume 35, Issue 1, pages 73–80, January 2012.

  • The Rate of CRT Upgrade

    • In the European CRT Survey of 2367 implant

    procedures, 29.2% were identified as having

    an upgrade from pacemaker to CRT-P or ICD

    to CRT-D.

    Bogale Nigussie et al. The European Cardiac Resynchronization Therapy Survey: comparison of outcomes between de novo cardiac

    resynchronization therapy implantations and upgrades. European Journal of Heart Failure Volume 13, Issue 9, pages 974–983, 2011.

  • AF in Paced Patients

    • Upgrading of an already implanted RV pacing

    system to BiV pacing in patients with HF and

    atrial fibrillation reversed dyssynchrony.

    • It improved ventricular performance and

    dimensions, quality of life and symptoms of

    HF in the same manner as described in patients

    with sinus rhythm and left bundle branch block

    who undergo BiV pacing.

    Leon AR, et al. Cardiac resynchronization in patients with congestive heart failure and chronic atrial fibrillation. Effect of

    upgrading to biventricular pacing after chronic right ventricular pacing. J Am Coll Cardiol 2002;39:1258–63.

    Erol-Yilmaz A, et al. Reversed remodeling of dilated left sided cardiomyopathy after upgrading from VVIR to VVIR biventricular

    pacing. Europace 2002;4:445–9.

  • Paced Patients with AF

    • Improvement in functional class, increased EF,

    decrease in end-systolic and end-diastolic

    diameters, decrease in the number of

    hospitalizations and improved quality of life

    scores were demonstrated in this patient

    population.

    • A 40% decrease in the MR area was reported

    in one of the two studies

    Valls-Bertault V, Fatemi M, et al. Assessment of upgrading to biventricular pacing in patients with right ventricular pacing and

    congestive heart failure after atrioventricular junctional ablation for chronic atrial fibrillation. Europace 2004; 6:438–43.

  • CRT-P vs. CRT-D

    • The use of CRT-D already exceeds that of

    CRT-P in many countries.

    • There is no evidence, however, from

    individual randomized trials nor from meta-

    analyses to suggest that CRT-D improves

    survival more than CRT-P in the primary

    prevention setting.

  • CARE-HF Study

    • CRT-P improves left ventricular function and

    potentially reduces the risk of subsequent

    SCD.

    • This is consistent with

    data from CARE-HF

    suggesting that CRT-P

    per se reduces SCD as

    well as total mortality.

    39%

    20%

    55%

    30%

    0%

    10%

    20%

    30%

    40%

    50%

    60%

    CRT Control

    Primary

    Endpointp

  • COMPANION Study

    • In the COMPANION study, survival curves

    between CRT-D and CRT-P were parallel

    beyond 9 months, suggesting that the

    incremental benefit of ICD may be short-lived.

    Michael R. Bristow et al. Cardiac-Resynchronization Therapy with or without an Implantable Defibrillator in Advanced Chronic Heart Failure.

    N Engl J Med 2004; 350:2140-2150

  • CRT-P vs. CRT-D

    • In deciding which device to implant in clinical

    practice, the physician will need to take into

    account clinical circumstances as well as

    societal, cultural, and financial factors of the

    individual countries.

    • Keep in mind that CRT-D seems to be

    associated with a higher risk of device-related

    complications as compared with CRT-P.

  • Complications

    • A higher risk of acute complications versus a

    de novo implant are reported.

    • This includes venous access issues, the risk of

    damage or extraction of old leads, the higher

    risk of infection, and the additional time that

    may be required.

  • Technical Considerations

    • Upgrades from RV pacing to CRT systems

    now comprise nearly 20% of CRT implants

    • Upgrading of previously implanted RV pacing

    systems has been attempted in the past by the

    use of different techniques, either using a

    variety of configurations of leads and

    connectors or by implanting new pulse

    generators.

    Rosen B. D. Resynchronization Therapy Upgrades: Turning Coach into First Class. J Cardiovasc Electrophysiol, Vol. 15, pp.

    1290-1292.

  • Techniques

    • Most studies have involved systems connecting

    both ventricular leads to a common internal

    current source.

    • This entails the risk of an

    impedance mismatch that

    could result in only RV or

    only LV pacing, rather than both.

    • Connecting two independent channels adds

    further programmability of the RV–LV

    stimulation delay.

  • Need for Contralateral Lead Placement

    Fox D. Upgrading Patients with Chronic Defibrillator Leads to a Biventricular System and Reducing Patient Risk: Contralateral

    LV Lead Placement. PACE 2006;29:1025–1027.l

  • Difficult Case

  • Subclavian Occlusion

  • Access from Right Side

  • Unstable Lead

  • Stenting of CS

  • Stenting of CS

  • Stable Lead Position

  • Lead Tunneled to Left Side

  • Lead Tunneled to Left Side

  • Final Position

  • Final Message

    • Given that dyssynchrony is the problem, or at

    least a prominent part of it, with pacing-

    induced or pacing-aggravated HF,

    resynchronization is a theoretically sound

    target to pursue.

    • The ‘upgrading’ approach

    to the treatment of already

    paced HF patients is at least

    feasible, relatively safe and most likely

    beneficial.

  • Cardiac Resynchronization Therapy in Patients

    With Systolic Heart Failure Who Need Pacing

    CRT can be useful for patients on GDMT who have LVEF less than or equal to 35% and are undergoing new or replacement device placement with anticipated requirement for significant (>40%) ventricular pacing.

    III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII

    Recs

    Modified

    2012

    2012 ACCF/AHA/HRS Focused Update of the 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities.

    Modified recommendation (wording changed to indicate benefit based on ejection fraction and need for pacing rather than NYHA class;

    class changed from IIb to IIa).

  • Tehran Arrhythmia Center

    WWW.IranEP.org

    [email protected]