IMPROVE CRT RESPONSE WITH MPP AND SYNCAV CRT

IMPROVE CRT RESPONSE WITH MPP AND SYNCAV CRT Adj Assoc Prof David Foo Head of Department, Senior Consultant Tan Tock Seng Hospital Singapore CRT and Heart Failure • Improvement in minute walk test • Improvement in NYHA functional class - most trials approx class • Improvement in left ventricular function and mitral regurgitation • Average decrease in Mn Living with Heart Failure Score of approx 10 points • Fairly consistent on secondary endpoint of decreased hospitalization for CHF • Improvement in mortality and morbidity 30% Non responder rate Challenges in patient selection, procedural and programming Anatomical Challenges Cardiac Resynchronization – Bipolar Clinical Challenges Duray et al reported that in 21% of cases with bipolar LV leads, the first pacing site chosen was not suitable due to lead instability and high pacing thresholds Lead instability and high pacing thresholds Phrenic Nerve Stimulation Lead Revision Duray, et al J of Cardio Electro, 2008 Cardiac Resynchronization – Bipolar Clinical Challenges Biffi et al reported 37% of CRT patients experience phrenic nerve stimulation (PNS) at implant or follow up Lead instability and high pacing thresholds Phrenic Nerve Stimulation Lead Revision Biffi M, et al CICEP, 2009 Cardiac Resynchronization – Bipolar Clinical Challenges Leon et al reported that 8% of CRT patients required lead revision Lead instability and high pacing thresholds Phrenic Nerve Stimulation Lead Revision Leon AR, et al J Am Coll Cardiol, 2005 Cardiac Resynchronization – Bipolar Clinical Challenges How can we overcome these most common CRT problems? Lead instability and high pacing thresholds Phrenic nerve stimulation Lead revision Quartet® LV Lead Quadripolar pacing technology would address the pacing complications and provides greater CRT efficiency during implant and follow up Proximal Mid Mid Distal tip Quadripolar Pacing Technology Duray, et al J of Cardio Electro, 2008 Has shown that with Quartet™ lead.The distal tip can be advanced close to apex to ensure lead stability while retaining pacing at a preferred location Proximal Lead stability and high pacing thresholds Distal Phrenic Nerve Stimulation Lead Revision CS anatomy prior to LV lead placement LV lead’s distal tip advanced close to the apex Quadripolar Pacing Technology Forleo GB, et al Heart Rhythm, 2011 Study outcome show that of quadripolar LV lead patients with PNS were successfully managed without lead repositioning Five of 23 patients in the bipolar group had PNS requiring a retraction or a repositioning of the lead to a different vein Single-center, prospective, controlled, non-randomized study 45 patients received CRT system 23 pts with bipolar LV lead PNS testing at implant 22 pts with quadripolar LV lead Lead instability and high pacing thresholds Phrenic Nerve Stimulation month Lead evaluation Forleo GB, et al Heart Rhythm, 2011 Lead Revision MPP™ Technology IDE Study Results: Importance of MPP Programming Post-hoc sub-analyses were conducted to determine the influence of MPP programming on CRT response (199 pts*): Sub-group Sub-group Sub-group < 30 mm (n=115) ≥ 30 mm & > ms TD (n=32) ≥ 30 mm & ms TD (n=52) Electrode Separation (≥ 30 mm) & TD > ms Electrode Separation (< 30 mm) Electrode Separation (≥ 30 mm) & TD = ms LVp LVp LVd RV LVp LVd RV >5ms LVd RV 5ms *2 of 201 patients randomized to MPP at months received BiV pacing due to phrenic nerve stimulation and/or high capture threshold CRT month Response – optimal MPP™ technology ALL MPP Patients (n=199) P= 0.003 87% 63% 69% Subgroup Subgroup Subgroup < 30mm Electrode spacing > 30mm Electrode spacing > 5ms timing delay > 30mm Electrode spacing 5ms timing delay (n=115) (n=32) (n=52) Optimal CRT Tomassoni, G., Baker II, J., Corbisiero, R., Love, C., Martin, D., Sheppard, R., Worley, S., Varma, N., Niazi, I (2016) Safety and efficacy of multipoint pacing in cardiac resynchronization therapy: The MultiPoint Pacing (MPP) IDE Study 2016 Heart Rhythm Society, LBCT 01-03 Converting Non Responders To responders P= 0.006 100% 62% 45% n = 45 n = 29 n=8 n=8  100% of patients who where non-responders at Randomization where converted to responders when programed to “Optimal MPP”  65% of non-responders randomized to continued Bi-V pacing became responders Tomassoni, G., Baker II, J., Corbisiero, R., Love, C., Martin, D., Sheppard, R., Worley, S., Varma, N., Niazi, I (2016) Safety and efficacy of multipoint pacing in cardiac resynchronization therapy: The MultiPoint Pacing (MPP) IDE Study 2016 Heart Rhythm Society, LBCT 01-03 MPP IDE Conclusions  MultiPoint Pacing™ technology (MPP™) is safe and effective  The enrolled patient population had a high response rate to Quadripolar BiV pacing  In this patient population, MPP pacing response rates are greatest when devices are programmed with wide LV electrode spacing and short intraventricular delay  There is an increasing body of evidence that MultiPoint Pacing can be used to improve responder rates Tomassoni, G., Baker II, J., Corbisiero, R., Love, C., Martin, D., Sheppard, R., Worley, S., Varma, N., Niazi, I (2016) Safety and efficacy of multipoint pacing in cardiac resynchronization therapy: The MultiPoint Pacing (MPP) IDE Study 2016 Heart Rhythm Society, LBCT 01-03 SYNCAV™ CRT What is SyncAV™ CRT? CRT-P Model Name Allure Quadra™ Allure Quadra™ RF Quadra Allure™ Quadra Allure MP™ Quadra Allure MP™ RF CRT-D • New algorithm • Designed to allow physicians to make CRT more individualized • Dynamic algorithm that works to make parameter changes out of clinic AVAILABLE ON THE FOLLOWING DEVICES Quadra Assura™ Quadra Assura MP™ Why SyncAV™ CRT? When enabled, SyncAV™ CRT continuously monitors the patient’s intrinsic AV conduction intervals and dynamically adjusts CRT parameters to changes in the patient’s conduction • SyncAV™ CRT HIGHLIGHTS – Automatic measurement of intrinsic AV conduction intervals – Programmable SyncAV™ CRT Delta shortens the programmed AV delays for a set number of cycles – Continuous 256 cycle search window – Programming steps are simple – Complimentary to MultiPoint™ pacing DESIGNED TO PROVIDE More Individualized CRT programming on a patient to patient basis Dynamic adjustment to variations in patient activity level, heart rate, conduction status, drugs, etc PROGRAMMING SyncAV™ CRT SyncAV™ CRT Setup steps Automatic Measurement of intrinsic AV conduction intervals Automatically measured when consecutive AS (or AP)–V-sense events occur Paced and Sensed AV Delays Automatically determined Review & Program SyncAV™ CRT settings Calculated based on measured intrinsic AV conduction interval DDD or VDD modes ONLY 4 SyncAV CRT adjusts the AV delay for the next 256 Every 256 cycles the AV delay is set to the SyncAV™312 CRT in action cycles AV conduction using the occurs following intrinsically equation: and SyncAV™ CRT programmed value for cycles (in this example 225 AV measures = (Intrinsic the conduction Conduction interval Time) for – these (SyncAV cycles CRT ms)Delay Delta) 199 184 184 Intrinsic Conduction Time = 184 ms SyncAV ™CRT delta = -50 ms AVDelay w/SyncAV™ CRT = (184 – 50) = 134 ms SyncAV™ CRT: Continuous rhythm monitoring 256 cycles Rate (bpm) Time to 256 Cycles (min) 50 5.1 60 4.3 70 3.7 80 3.2 90 2.8 SyncAV™ CRT Dynamically Tailored to the patient’s beat • New dynamic timing feature for quadripolar CRT devices, it can complement Multipoint™ Pacing • Individualize and dynamically adjust timing (AV Delays) based on intrinsic patient rhythm • Drive fusion with intrinsic rhythm for improved electrical synchrony and narrower QRS¹ MultiPoint™ Pacing with SyncAV™ CRT technology AV Node LV Intrinsic Conduction LV/RV Pacing RV QRS Reduction with SyncAV™ CRT technology • • • • • Acute Data from Cleveland Clinic shows the value of dynamic timing optimization and fusion pacing1 Using a delta value of -50ms, fusion pacing was achieved and provided a 20% improvement in QRS width Methodology improved QRS duration over traditional fixed AV delays and LV only pacing Incremental QRS narrowing can be achieved by fine-tuning delta value, programmable only in SJM™ SyncAV feature Data uses Neg-Hys predicate version of SyncAV™ CRT feature¹ P < 0.01 P < 0.01 P < 0.01 QRSd 142 ± 18 ms 131 ± 12 ms 123 ± 10 ms 140 ± 15 ms Conclusions • MPP shown to be beneficial for CRT patients, overcomes implant limitations and increases responder rates • SyncAV further fine tunes individual needs to biventricular pacing, allowing maximum derivation of CRT benefit in daily activities THANK YOU ... reduced and EF improved with MultiPoint Pacing relative to conventional BiV Unmatched CRT Response with MultiPoint™ Pacing 19% improvement in responder rates at 12 months4 Unmatched CRT Response. .. of 201 patients randomized to MPP at months received BiV pacing due to phrenic nerve stimulation and/ or high capture threshold CRT month Response – optimal MPP technology ALL MPP Patients (n=199).. .CRT and Heart Failure • Improvement in minute walk test • Improvement in NYHA functional class - most trials approx class • Improvement in left ventricular function and mitral regurgitation