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