Safety and Efficacy of a Leadless Pacemaker: Results from the LEADLESS II clinical trial

Transcription

1 Safety and Efficacy f a Leadless Pacemaker: Results frm the LEADLESS II clinical trial Vivek Y. Reddy, MD, T. Jared Bunch, MD, Daniel J. Cantilln, MD, Rahul Dshi, MD, N.A. Mark Estes, MD, Derek V. Exner, MD, Paul Friedman, MD, Gery Tmassni, MD, Jhn Ip, MD, Kenneth Plunkitt, MD Icahn Schl f Medicine at Munt Sinai, New Yrk, NY, Intermuntain Medical Center Heart Institute, Salt Lake City, UT, Cleveland Clinic, Cleveland, OH, USC University Hspital, Ls Angeles, CA, Tufts University, Bstn, MA, Libin Cardivascular Institute f Alberta, Calgary, Canada, May Clinic, Rchester, MN, Central Baptist Hspital, Lexingtn, KY, Sparrw Research, Lansing, MI, Naples Cmmunity Hspital, Naples, FL. COI: St Jude Medical Inc Grant supprt & Cnsultant I will be discussing the use f nn-fda apprved devices

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3 Percutaneus femral vein delivery - 18F intrducer /steerable catheter - <30 minute skin-t-skin prcedure Self-cntained device in ventricle - N lead r surgical pcket - Inherently MRI cmpatible Cnventinal Features -Temperature-Based Rate Respnse - >10-yr battery life - Hysteresis - Magnet Mde Tday s Leadless Pacemaker System The Nanstim Device Flexible replacement ptins - Catheter-based retrieval - Deliver additinal leadless pacemakers - Revert t cnventinal pacing lead 3 Prprietary and Cnfidential

4 Leadless II Clinical Trial Overview Prspective, multicenter, nn-randmized, FDA IDE study Objective: T evaluate the clinical safety and efficacy f nn-surgical implantatin f the leadless cardiac pacemaker in patients indicated fr a VVI(R) pacemaker. Primary Chrt: 1 st 300 patients fllwed fr 6m (June 2015) Ttal Chrt: All patients enrlled by June 2015 (n=526) Primary Endpints (by ITT): Safety: Freedm frm Serius Adverse Device Effects at 6 mnths Efficacy: Acceptable pacing capture threshld (d2.0 V at 0.4 msec) and a therapeutically acceptable sensing amplitude (R wave e5.0 mv, r a value equal t r greater than the value at implantatin) thrugh 6 m. 56 Centers in the US, Canada and Australia 100 Operatrs (nly ne had prir experience with leadless pacing)

5 Device was successfully implanted in ~96% f patients Primary Safety Endpint (Intent-t-Treat Analysis) 280 f the 300 patients achieved endpint (93.3%; 95% CI = 89.9 t 95.9) This exceeded the perfrmance gal f 86% (P<0.001) Primary Efficacy Endpint (Intent-t-Treat Analysis) 270 f the 300 patients achieved endpint (90.0%; 95% CI = 86.0 t 93.2) This exceeded the perfrmance gal f 85% (P = 0.007) Efficacy (Successful implants) 289 patients with successful device implant Leadless II Clinical Trial Outcmes 270 f the 289 patients achieved endpint (93.4%; 95% CI = 89.9 t 96.0) This exceeded the perfrmance gal f 85% (P <0.001) Based n device-use characteristics, the battery lngevity is estimated t be 15.0 ± 6.7 yrs (95% CI, 14.2 t 15.8 yrs)

6 Leadless II Clinical Trial Device-Related SAEs * * * Includes: ischemic strke, angina pectris, pericarditis, acute cnfusin & expressive aphasia, dysarthria & lethargy pst implant, cntrast induced nephrpathy, rthstatic hyptensin with weakness, left leg weakness during implant, prbable pulmnary emblism, ischemic strke

7 Leadless II Clinical Trial Cnclusins The Leadless Pacemaker was successfully implanted in ~96% f attempted patients. The trial met the pre-specified Safety and Efficacy endpints Cmplicatin rate similar t that seen with cnventinal pacemakers Cmplicatin rate likely t imprve with peratr experience (Rem: in this study, 99 f 100 peratrs had never implanted a leadless device) The device was shwn t be retrievable in a subgrup f patients (n=7) wh needed a replacement (Time frm implant = 160±180 days; Range = 1 t 413 days) The estimated device lngevity based n the 6-mnth fllwup duratin is encuraging

8 An Observatinal study (nt Randmized) Mean Fllw-Up f nly 6 mnths Hw t manage device after battery depletin? Pssible t retrieve after ~1 year, but what abut 5, 10, 15 yrs? Retrieval vs Abandnment Limited device diagnstics (eg, n electrgram data) Large venus sheath (18Fr) Nw increasingly cmmn used fr cardilgy prcedures Lw bserved rate f hematmas Single chamber (RV) pacing nly Leadless II Clinical Trial Limitatins Device-t-device cmmunicatin is in develpment Wuld lead t dual-chamber, CRT, etc