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The EP Show: Right ventricular vs biventricular pacing

The EP Show: Right ventricular vs biventricular pacing. Eric Prystowsky MD Director, Clinical Electrophysiology Laboratory St Vincent Hospital Indianapolis, IN Bruce Wilkoff MD Director, Cardiac Pacing/Tachyarrhythmia Devices Cleveland Clinic Cleveland, OH Leslie Saxon MD

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The EP Show: Right ventricular vs biventricular pacing

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  1. The EP Show:Right ventricular vs biventricular pacing Eric Prystowsky MD Director, Clinical Electrophysiology Laboratory St Vincent Hospital Indianapolis, IN Bruce Wilkoff MD Director, Cardiac Pacing/Tachyarrhythmia Devices Cleveland Clinic Cleveland, OH Leslie Saxon MD Director, Department of Electrophysiology USC University Hospital Los Angeles, CA Michael Gold MD Chief, Division of Cardiology Medical University South Carolina Charleston, SC

  2. Right ventricular vs biventricular pacing Can long-term right ventricular pacing actually hurt the heart? June 2004

  3. How to pace? • "Systole is better than asystole." • If the heart needs to be paced, and there is heart block, the ventricle needs to be paced somehow • CONTROVERSY • Pacing the atrium in AAI mode vs pacing in VVI or DDD modes • Europeans lead way in promoting atrial pacing over ventricular pacing Wilkoff June 2004

  4. The data • Data clear that wall-motion abnormality produced when ventricle is paced • DDD vs VVI, as well as other trials, all include ventricular pacing • Danish observational data suggest there is a mortality benefit with atrial pacing June 2004 - Wilkoff

  5. DAVIDDual-Chamber and VVI Implantable Defibrillator Comparison of ICD therapy with dual-chamber pacing vs ventricular backup pacing June 2004

  6. DAVID trial: DDDR-70 vs VVI-40 programming The DAVID trial investigators. JAMA 2002; 288:3115-3123.

  7. DAVID trial • Pacing really caused a significant detriment to these patients • The change in mortality and HF was equal to the benefit of amiodarone seen in the original AVID trials • Large effect on HF and mortality without RV pacing, at least in patients who needed • defibrillators and had ventricular dysfunction Wilkoff June 2004

  8. Landmark study • In some ways, the DAVID trial is one of the first randomized pacing trials • Treatment vs nontreatment group • First trial to show an isolated effect of DDDR pacing and RV pacing on HF and mortality June 2004

  9. MADIT II • Consistent with DAVID, MADIT II patients with dual-chamber defibrillators had a higher rate of hospitalization for heart failure than those with single-chamber devices • Consensus emerging that RV pacing may be hurting patients • Trying now to get the benefit of an atrial lead without • ventricular pacing Gold June 2004

  10. Biventricular pacing • Resynchronization therapy performed with simultaneous RV and LV pacing; or pace with LV alone • Most data with biventricular pacing in symptomatic HF patients with conduction disease June 2004

  11. Biventricular pacing • Patients feel better and exercise more, systolic response improves, and possible reverse remodeling • Sickest patients appear to live longer and require fewer hospitalizations June 2004

  12. Biventricular pacing • What about the brady-indicated patient who does not meet criteria for CRT? • Help vs harm • What is the risk of RV-pacing-induced left bundle branch block? • How will this hurt the patient in the short and long term? June 2004 - Saxon

  13. Biventricular pacing • "I think in some patients, chronic RV pacing will cause left ventricular dysfunction." • Not a majority • In patients with LV dysfunction but with native left bundle branch block, RV pacing will not likely make that ventricle worse • May be improved with biventricular pacing, but requires careful evaluation Saxon June 2004

  14. A recurring question • What about the patient with chronic RV pacing and LV dysfunction who comes to the lab for an elective battery replacement? • Upgrade to CRT represent "half of what I'm doing these days" • Begin to think about the patient under the criteria of other prophylactic studies, such as MADIT II and SCD-HeFT June 2004 - Saxon

  15. How is the LV paced? • LV pacing achieved similar to right-sided implants • LV lead placed into the venous system • LV branch vein accessed through the coronary sinus great cardiac vein • Coronary sinus accessed in a retrograde fashion from the lower right atrium • Guide catheter employed into the great cardiac vein, with lead deployed into branch vein to pace the left ventricle June 2004 - Saxon

  16. Negative effects of RV pacing Not only does chronic RV pacing induce LV dyssynchrony, but even if atrial transport is maintained in DDD mode, there is an increased risk of atrial fibrillation, in addition to the increased risk of heart failure Saxon June 2004

  17. Indications for biventricular pacing INDICATIONS • Patients with class 3 or 4 heart failure, despite optimal medical treatment • EF <35% • Wide QRS interval (at least 120-130 ms) • Left bundle branch block patient (typically) June 2004

  18. AF data • "I think the AF data are difficult and confusing." • Lack of P wave needed to pace ventricle • "The data we do have suggests these patients can benefit if you can achieve frequent, if not continuous, biventricular pacing." Gold June 2004

  19. Recent answers Who gets a defibrillator? Two major trials: SCD-HeFTSudden Cardiac Death in Heart Failure Trial COMPANIONComparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure June 2004

  20. SCD-HeFT mortality data Bardy G. American College of Cardiology 2004 Scientific Sessions; Mar 7-10, 2004; New Orleans, LA.

  21. COMPANION: 12-month outcomes a OMT=Optimal medical therapy b p vs optimal medical therapy without device therapy HR=hazard ratio CI=confidence intervals Bristow MR et al. N Engl J Med 2004; 350:2140-2150.

  22. Impact • SCD-HeFT and COMPANION • "Those studies have certainly made us move more and more toward combining defibrillators with biventricular pacing in a majority of our patients." Gold June 2004

  23. CRT plus a defibrillator • Is it fair to say that if patients meet the criteria for biventricular pacing, they will also have an indication for a defibrillator? • - Prystowsky • Yes, the clinical data support it. • - Gold June 2004

  24. Biventricular pacemaker or defibrillator? • "There is another issue here and it has to do with reimbursement. We have to bring in who is going to pay for this." • Still some "fuzziness" to NYHA functional class • How do we treat the NYHA class 2 HF patients? • Reimbursement decision expected from CMS by September 2004 Wilkoff June 2004

  25. Nonischemic HF • Very little data to support the use of defibrillators in dilated nonischemic cardiomyopathy patients DEFINITE study • Medically managed HF patients with nonischemic cardiomyopathy implanted with an ICD showed a nonsignificant reduction in all-cause mortality with device therapy "We're in a little bit of a bind here. We have some good clinical data, but we don't have administrative approval to be putting defibrillators in all these patients." - Wilkoff June 2004

  26. Social issues • "There are a number of people that just don't relate to the concept of having an implantable defibrillator." • Need to discuss implications, but in general, if presented properly, most patients will want the device; others will refuse • In ischemic patients, where there is reimbursement, we should be pushing for biventricular defibrillator devices Wilkoff June 2004

  27. Patient selection • OTHER INDICATORS • Wall motion indices as possibly superior to QRS duration? • Response rates, in terms of clinical improvement, can be frustrating, especially in patients who meet standard criteria June 2004

  28. Other indicators • The wider the QRS, the greater the probability of benefit • But QRS is a surrogate marker so there is a need to look for other, more direct, measures of dyssynchrony • Echo and nuclear measures as possible predictors of patient benefit Gold June 2004

  29. More data needed • "I think this is an evolving field that's very interesting in trying to select these patients, but unfortunately we don't have long-term outcome data using these measures." June 2004 - Gold

  30. Not there yet Mechanical dysfunction identified typically by an ECG "It's not really the disease. It is a surrogate for the wall motion abnormality that we're trying to correct with an electrical answer." "It is likely that we're going to have better measures for dyssynchrony and we're going to find better ways of identifying patients." • - Wilkoff June 2004

  31. The future • Moving toward resynchronization in a larger group of patients • Need for studies to determine whether various imaging indices can prospectively identify responders • "Right now, these imaging methods are really experimental and should not be used as selection criteria." Saxon June 2004

  32. The future • Issue of whether the ventricle can resynchronized with LV pacing alone is fascinating • Early European data showing that LV pacing alone can improve the "feel-good" parameters as much as biventricular pacing • Echo studies preliminary, but comparable • QRS actually widens June 2004

  33. The future • New studies in brady-indicated patients randomized--regardless of LV function--to biventricular/LV pacing vs RV pacing alone • Issue of who needs defibrillation has been worked out by the ICD trials that will trump indications for these patients currently under FDA approval June 2004

  34. Off-label use • BEDSIDE PRACTICE • "You can't always wait for trials." • - Prystowsky • "I'm maybe more conservative than others, having been through the wars of biventricular pacing." • - Gold June 2004

  35. Off-label use • "In general, if I have a patient with preserved LV function who is going to be pacing, whether because I've created complete heart block with an ablation or because they have intrinsic AV node disease, I will still tend to RV pace them. I know that's a safe, simple, reliable system." Gold June 2004

  36. The guy in the corner • "Am I the only person who is pacing some selected patients with a biventricular system that aren't in class 3 or 4 heart failure?" • - Prystowsky • "No, I'm doing it, Eric." • - Saxon • PAVE trial showed improved exercise capacity in less symptomatic patients who were implanted with a biventricular device June 2004

  37. Caution urged • However, subanalysis in PAVE showed that the improvement was only in patients with EF <40% • There was no benefit in patients who had preserved EF • Study overall had a statistically significant end point, but subgroups had disparate results Gold June 2004

  38. Not hypothetical • "These are not general and new guidelines. These are totally off the guidelines." • But the technology is available and it is not hypothetical. Clearly, it is a patient-by-patient discussion Prystowsky June 2004

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