In this ppt i am going to discuss new breakthrough study in the field of CRT, famously known as SELECT-LV study.

1. Presenter
Praveen Gupta
Moderator
Dr Raja selvaraj
Department of
Cardiology
JIPMER
Pondicherry
INDIA
03.07.2017
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SELECT-LV Study

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3. Introduction
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 CRT -LV pacing via an coronary sinus is first-line approach
 30% to 40% are non-responder
 8% to 10% do not receive CRT due to absence of CS targets, occlusion of the upper extremity venous
system, phrenic nerve stimulation, or high pacing threshold
 Use epicardial and transseptal endocardial LV pacing
 Epicardial lead placement invasive , challenging with prior cardiac and lower survival
 Transseptal LV endocardial stimulation benefits physiological, less proarrhythmic ,limited by the
thromboembolic risk, need anticoagulation, and effects on the mitral valve
 System performs endocardial LV stimulation, but does not require thoracotomy or anticoagulation, would
be an attractive option

4. Introduction
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 Novel wireless cardiac resynchronization system (WiSE-CRT, EBR Systems, Sunnyvale, California) was
developed to pace the LV endocardium with a small wireless pacing electrode
 Provides wireless pacing by transmitting ultrasonic from a pulse generator , implanted over ribcage, to a
receiver electrode implanted in the LV functions in conjunction with RV pacing system
 Biventricular pacing is achieved by sensing RV pacing output of the coimplant, followed by the system
immediately transmitting acoustic energy to the electrode, thus achieving nearly simultaneous pacing of
the RV and LV.
 The transmitter is a phased array ultrasound system that focuses the acoustic energy on the electrode.

5. SELECT-LV (Safety and Performance of
Electrodes implanted in the Left Ventricle) study
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 Prospective
 Multicenter
 clinical trial
 6-month outcomes
 Evaluation of the performance and safety of the WiSECRT System in patients indicated for CRT who had
“failed” conventional CRT

6. Inclusion and exclusion criteria
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Inclusion criteria
 Indication for CRT and at least 1 of the following criteria:
 Upgrades: CS lead not advisable- infection or venous obstruction
 Untreated”: CS lead failed- difficult anatomy, phrenic nerve capture
 Nonresponders”: Previous CRT with worsening NYHA after 6 mths
Excluded criteria
 Nonambulatory NYHA class IV HF
 Contraindication to heparin, anticoagulation and antiplatelet
 Stage 4 or 5 CKD
 Major cardiac surgery within the prior month, or noncardiac implanted electrical stimulation devices

7. Endpoints
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Primary endpoint
 Biventricular pacing at 1 month
 Primary safety endpoints were device complications at 24 h post-implant, and from 24 h to
30 days
Secondary efficacy endpoints
 Change in the HF clinical composite score (all-cause mortality, HF hospitalization, NYHA
functional class, and patient global assessment) at 6 months
 Change in echocardiographic left ventricular end-systolic volume (LVESV), left ventricular
enddiastolic volume (LVEDV), and LVEF at 6 months

8. Endpoints
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Positive responses to CRT between baseline and at 6 months defined as
 Reduction in LVESV by 15%
 Reduction in LVEDV by 10%
 Improvement in LVEF by 5%
 improvement of NYHA functional class by 1
 Secondary safety endpoints included device-related complications between 1 and 6 months.
 Follow-up-At pre-discharge,1 week, 1 month, 2 months, and 6 months

9. System details and implantation
WiSE-CRT system consists of 4 components
 12-F delivery catheter system
 8-F retractable delivery catheter with a pre-
mounted receiver electrode the electrode is an
ultrasound receiver and energy converter, and
is implanted in the LV
 Pulse generator that consists of an ultrasound
energy pulse transmitter and a battery
 Programmer
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10. Demographic parameter of the patients
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11. Result
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12. Result
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13. Result
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14. Result
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15. Discussion
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SELECT-LV trial demonstrated
 Cardiac resynchronization with endocardial LV stimulation via a novel leadless pacing
electrode was technically feasible and efficacious.
 High implant success rate (97%)
 Improvements in the HF clinical composite score in 85%
 Positive echo response (reduction in LVESV 15%) in 52% at 6 months.
 Evidence of electrical remodeling
 Reductions in the intrinsic QRS duration:
 Largely patients who failed or were poor candidates for conventional CRT

16. Discussion
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 WiSE-CRT study, stopped high pericardial tamponade ( 18%),
 SELECT-LV trial was redesigned that the distal portion of the delivery sheath equipped with
a balloon to facilitate atraumatic engagement with the LV endocardium
 occurrence of ventricular fibrillation
 2 infections

17. Study limitations
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 Nonrandomized trial
 Absence of a core echocardiography laboratory
 2 chest wall incisions
 Infectious complications
 Retrograde arterial access
 Vascular complications
 Not account newer quadripolar coronary sinus pacing leads
 Thromboembolic complications
 Anticoagulation strategy (antiplatelets vs. systemic
 oral anticoagulation) remains to be determined.
 Endocardial scar and inadequate acoustic windows negatively affect the performance and battery life of the system
 7.7% of the patients did not have an adequate acoustic window

18. Study limitations
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 Methods of the study did not include optimal site selection strategies in the LV or emphasize
concurrence of “clinical” site selection with acoustic windows
 The need for and ability to retrieve a long-term implanted pacing electrode remains untested

19. Conclusions
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 The SELECT-LV study has demonstrated the clinical feasibility for the WiSE-CRT system
 Benefits in patients with a standard indication for CRT who met the criteria of upgrade,
untreated, or nonresponder, a “failed” CRT population

20. Animation video of WiSE-CRT system
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Thank You