9/14/2019 Disclosures His Purkinje Conduction System Pacing Should be First Line Therapy for AV Block with Preserved LV function Advisory board - Boston Scientific - Eaglepoint LLC Speaker, Consultant, Research, - Medtronic Fellowship support Pugazhendhi Vijayaraman MD Consultant - Abbott, Biotronik, Merritt Medical Professor of Medicine His delivery tool - Patent pending Geisinger Commonwealth School of Medicine Geisinger Heart Institute Wilkes Barre, PA 1 2 Kusumoto F, et al. Circulation 2018Nov 6:CIR0000000000000627 3 Kusumoto F, et al. Circulation 2018Nov 6:CIR0000000000000627 4 1
9/14/2019 Kusumoto F, et al. Circulation 2018Nov 6:CIR0000000000000627 Kusumoto F, et al. Circulation 2018Nov 6:CIR0000000000000627 5 6 Pacing acing Concer Concern n is Not is Not New New • “Pressure developed. . .after . . .contraction is far less in the artificially than in the naturally elicited beats. [U]ndoubtedly its significance must be. . . carefully considered” 8 7 Wiggers CJ, Am J Physiol 73: 346; 1925 2
9/14/2019 Right t Ventri tricular r Pacing MOST – Freedom from first HFH A Form of Desynchronization Therapy Acute Changes Longstanding Effects Freedom from first HFH HR 2.6 9 10 Sweeney MO. J Am Coll Cardiol 47:282-288; 2006 The DAVID Trial Heart Failure post RV pacing CHF admissions/mortality Mean RV pacing Cumulative probability P=0.03 = 58.9 ± 36.0% Mean RV pacing = 3.5 ± 14.9% Months to death or heart failure hospitalization 12 Willkoff BL. JAMA 2002; 288:3115 – 3123 3
9/14/2019 Time Course Chronic Phase (6 months – 4 Years) Acute Phase (0-6 months) HR 1.62 (95% CI: 1.48-1.79, p<0.001) HR 1.16 (95% CI: 1.08-1.25, p<0.001) | 14 | | 15 17 4
9/14/2019 ECG Imaging His bundle pacing- The new paradigm in pacing • Replicates true physiology (what nature has selected over millions of years of human evolution) • The most efficient way to stimulate the ventricles (QRS duration ranges from 50 ms to 110 ms in most humans over their lifespan) • The ideal form of AV and VV (intra and interventricular) synchrony; no other existing form of pacing can claim this as the ventricle is non-physiologically activated Ploux S,..Bordacher P. Heart Rhythm 2015;12:782 – 791 19 18 Vijayaraman et al. JACC 2018;72:927-47 18 9/14/2019 His Bundle Pacing • First described by Scherlag et al in 1967 in dog • Narula et al described temporary His bundle pacing in humans in 1976 • Deshmukh et al (2000) described permanent His bundle pacing in 18 pts with – Dilated CMP, chronic AF, normal QRS, AVN ablation – Successful in 12 pts – Pacing threshold 2.4 ± 1.0 V @0.5 ms, R wave 1-3.2 mV – LVEF improved from 20 ± 9% to 31 ± 11% – Lead dislodgement 2 pts 20 5
9/14/2019 ROVIGO EXPERIENCE P = 0.144 65 61.2 60.7 60 55 P < 0.001 50 BASELINE 44 45 POST- IMPLANT 40 37.4 35 30 EF > 45% EF ≤ 45% HBP compared to RV pacing: Procedural Outcomes Long-term performance His Bundle Pacing (HBP) RV Pacing 192 PPMs implanted Number of patients (n, %) 75, 80% 98, 100% 2011 Baseline QRS duration (ms) 109±26 102±24 Paced QRS duration (ms) 124±22 124±22 168±21 168±21 98 94 Fluoroscopy times (min) - median 9.2 6.4 RV pacing HBP attempted group Pacing thresholds (V @ 0.5 ms) Mean ± SD Mean ± SD 1.35 ± 0.9 0.62±0.5 Implant 1.35 ± 0.9 0.62±0.5 1 year 1.60± 0.9 0.80±0.3 75 (80%) 19 implanted in 60 RV apex 38 RV septum successful HBP RV septum 2 year 1.50±0.8 0.80±0.4 5 year 1.62±1.0 1.62±1.0 0.84±0.4 0.84±0.4 Vijayaraman P, et al. Heart Rhythm 2018;15:696-702 Vijayaraman P, et al. Heart Rhythm 2018;15:696-702 24 25 6
9/14/2019 At 5 years Combined End-point of Death or Heart Failure Hospitalization All Patients Patients with VP >40% P=NS P=0.002 P=NS P<0.001 All Patients Patients with >40% VP B 60 Ejection Fraction % Freedom from death or HFH ---- HBP (N=75) ---- HBP (N=47) 55 ---- RVP (N=98) ---- RVP (N=60) 50 45 Baseline 40 Follow-up 35 P=0.04 P=0.02 30 HR 1.7 HR 2.1 25 HBP RVP HBP RVP Follow-up (years) On Treatment Follow-up (years) Vijayaraman P, et al. Heart Rhythm 2018;15:696-702 Long-Term Lead Performance and Clinical Outcomes Clinical Outcomes 5-year follow-up data 192 pts 765 Patients HBP RV pacing 75/94 (80%) pts 98 pts 332 433 Device parameters 1.62±1.0 (@0.5ms) 0.84±0.4 (@0.5ms) P<0.01 Pacing Threshold HBP attempted RV pacing 5 (6.7%) 2 (3%) Lead revisions 7 (9%) 1 (1%) Generator changes 304 (92%) 28 (8%) 176 (41%) 257 (59%) QRS duration (paced) 126±29 ms 170±31 ms P<0.01 successful HBP RV septum RV apex Non-apical LV Ejection Fraction 57 ± 6 % 52 ± 11 % P<0.001 Pacing Induced CMP 1 (2%) 13 (22%) P<0.01 ➢ Mean Follow-up duration 725 ± 423 days Death or HFH in pts with ➢ 220 reached the primary endpoint VP>40% 19,32% 32, 53% P=0.04 (INTENTION TO TREAT) Abdelrahman M,…Vijayaraman P. JACC 2018;71:2319 -30 29 7
9/14/2019 Primary Outcome (Death, HFH or upgrade to Procedural biventricular pacing) All patients Characteristics His Bundle pacing (n=304) RV pacing (n=433) P-value Procedure duration (min) 70.21±34 55.02±25 <0.01* Fluoroscopy duration (min) 10.27±6.5 7.40±5.1 <0.01* 83/332 (25%) Implant Capture threshold (V @ ms) 1.30±0.85 @ 0.79±0.26 0.59±0.42 @ 0.5±0.03 <0.01* 137/433 Last follow up Capture threshold (V @ ms) 1.56±0.95 @ 0.78±0.30 0.76±0.29 @ 0.46±0.09 <0.01* (32%) QRS duration (ms) 104.5±24.5 110.5±28.4 <0.01* Paced QRS duration (ms) 128±27.7 166±21.8 <0.01* 30 31 Heart Failure Hospitalizations Primary Outcome (Death, HFH or upgrade to biventricular pacing) Patients with VP >20% 49/194 (25%) 99/278 (36%) 32 33 8
9/14/2019 All- Cause Mortality 477 consecutive patients who underwent PM implantation for complete/advanced AVB. Ventricular pacing leads were located in the HA 148 RVS 140 RVA 189 34 https://doi.org/10.1016/j.cjca.2017.09.013 LBB pacing can be easily achieved? AV nodal HB Narrow target LBB HB accurate positioning needed Wider conduction net LB Easy to find and fix B The he first t case re repor portdescrib ribedLBB pacingtha hat cor orrected LBBB with th a low and nd sta table threshold by RB B pacing ng the he LBB re region on immedi diately beyon ond d the he con onduc uction on bloc ock. • By venou ous access; ; Tra rans and nd intr ntraventric ricular r sept ptum; ; Deep sept ptal pacing at t Peri ri-LBB Area • Demon onstr trate LBB pote otential and nd RBBB mor orph pholog ogy of paced d QRS com omplex • with th or witho thout t selecti tive LBB pacing 37 9
9/14/2019 Bipolar Pacing I I II II III III aVR aVR aVL aVL aVF aVF V1 V1 V2 V2 V3 V3 V4 V4 V5 V5 V6 V6 RA 0.5V 3.0V 1.0V H LB LBBP HBP LBB RV+LV+LBB NS-LBBP S-LBBP RAO 30 ° LAO 45 ° The depth of the lead tip in the ventricular septum by echo and CT scan Sheath angiography 41 10
9/14/2019 Conclusions Summary “When the speed of rushing • water reaches the point His Purkinje Conduction System Pacing is feasible and safe in all patients requiring ventricular pacing where it can move boulders, this is the force of • HPCSP should be the first line therapy in patients requiring momentum.” ventricular pacing. 100 HBP Publications 90 • It is elegant in its simplicity and it is trying to “repair” existing 80 conduction problems rather than “replace” it with a new artificial and 70 suboptimal conduction pattern 60 50 40 • Reinstate “Physiology” in Electrophysiology 30 20 10 0 Year 09 10 11 12 13 14 15 16 17 18 19 (Aug) 42 1 2 3 4 5 6 7 8 9 10 11 43 42 9/14/2019 11
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