Top 5 Things to Know about Pacemakers and ICD s. Jeffrey S. Osborn, M.D., C.C.D.S. March 4, 2017.

Transcription

1 Top 5 Things to Know about Pacemakers and ICD s Jeffrey S. Osborn, M.D., C.C.D.S. March 4, 2017.

2 Top 5 Things 1. Remote Monitoring leads to better care and outcomes. 2. MRI s CAN be done on device patients. 3. Leadless Pacemakers are the future of Pacing. 4. SubQ ICD can be an alternative to ICD s 5. Bridge Balloon can reduce the risk of lead extraction.

3 What CIED s allow for Remote Monitoring Some Implantable Loop Recorders Pacemakers-single, dual and BiV Pacers ICD s-single, dual or BiV includes SubQ ICD now

4 What Alerts can be set up on Remote Monitoring? Battery at ERI Lead Integrity- impedances, threshold, sensing Atrial and Ventricular arrhythmias Afib episodes greater than 24 hours Tachy Therapies Turned Off % BiV pacing Weight gain or loss Other heart failure parameters

5 Remotely Monitoring Helps Reduce Total Spending by 9% Total Cost - 3 Years $70,000 $60,000 $50,000 p= % $58,453 $53,000 No Remote Monitoring Remote Monitoring p= % $40,000 $46,023 $42,110 $30,000 $20,000 $10,000 n=3219 n=516 n=8404 n=1267 $- With AF No AF USD study using retrospective claims analysis of Medicare 5% sample Limited Data Set Standard Analytical Files claims and enrollment data. The analysis identified all pacemaker implants and revisions in the sample from the 2006 and 2007 calendar years (totaling 19,954 cases). Cases were identified in which patients were alive in the quarter following the implant. Costs and outcomes were calculated for the three years following implant, and pacemakeronly cases were segregated from pacemaker/af diagnosis cases. The analysis included AF diagnoses identified at any point in the two quarters prior to implant and up to six quarters post-implantation. The risk adjusted regression used patient demographics and the Medicare Hierarchical Conditions Categories model St. Jude Medical. Data on File.

6 PREFER Study Results 1 The PREFER study showed that remote monitoring of pacemaker patients via the CareLink Network detected clinically actionable events (CAEs) more quickly than routine followup care via transtelephonic monitoring (TTM) and in-office visits. Th What did the study conclude? 1.Clinically important and actionable events are detected more quickly and frequently by a strategy of pacemaker follow-up that includes remote interrogation instead of TTM monitoring. 2.The value of TTM is limited and may be of clinical significance only for the detection of battery depletion. 3.Systematic use of pacemaker follow-up with remote interrogation has the potential to improve outcomes by reducing the time between onset and detection of clinical pathology and indicated therapeutic options. Probability of Identifying CAE over Time Remote Interrogation TTM CAE Detected Remotely 66% (446) 2% (3) CAE Detected In-office 34% (230) 98% (187)

7 Benefits of Remote Monitoring Only Realized If Patients Are Compliant Problem: Poor patient compliance with remote follow-up 45% of automatic clinical alerts are not successfully transmitted because the home monitor is not properly set up by the patient. 1 Solution: Day 1 monitoring activation proven to improve compliance Point-of-Care Only St. Jude Pairing Medical offers point-of-care pairing to activate the home monitor before patient leaves the hospital. Improved Efficiency Same day discharge; peri-operative follow-up Increased Patient Satisfaction Reduce patient burden of setup Peace-of-mind with daily monitoring Improved Outcomes Reduced hospitalizations & costs Earlier intervention 1. Crossley GH, Boyle A, Vitense H, et al. The CONNECT Trial. The value of wireless remote monitoring with automatic clinician alerts. J Am Coll Cardiol. 2011;57(10):

8 ALTITUDE STUDY For the ICD and CRT -D patients receiving remote follow-up on the network, 1- and 5-year survival rates were higher compared with those in the patients who received device follow-up in device clinics only (50% reduction; P<O.OOOl).

9 Automatic Remote Monitoring of Implantable Cardioverter-Defibrillator Lead and Generator Performance The Lumos-T Safely RedUceS RouTine Office Device Follow-Up (TRUST) Trial Conclusions ICD lead and generator malfunction was infrequent and often asymptomatic. Only a minority of detected events required surgical intervention. Automatic HM enhanced discovery, permitted prompt detection, and facilitated management decisions. Longitudinal parameter trending, with component function evaluated daily by remote monitoring, may enable long-term performance assessment. Clinical Trial Registration URL: Unique identifier: NCT (Circ Arrhythm Electrophysiol. 2010;3: )

10 The CONNECT (Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision) Trial The Value of Wireless Remote Monitoring With Automatic Clinician Alerts Conclusions Wireless remote monitoring with automatic clinician alerts as compared with standard in-office follow-up significantly reduced the time to a clinical decision in response to clinical events and was associated with a significant reduction in mean length of CV hospital stay. (Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision [CONNECT]; NCT ) (J Am Coll Cardiol 2011;57:1181 9) 2011 by the American College of Cardiology Foundation

11 Conclusions Remote patient management is a proven strategy that enables the management of implantable cardiac devices by providing a solution that is patient-centric, consumption-sensitive, and one that contributes to health status improvement.

12 Conclusions As patients become more connected and as care becomes increasingly less centralized, remote management of patients with cardiac devices delivers today on the promise of a true health information ecosystem: one that promotes continuity of care and population health management. If remote monitoring is available it should be used.

13 MagnaSafe Study in NEJM

14 Subcutaneous-ICD System Designed to sense, detect and treat malignant ventricular tachyarrhythmias S-ICD System is entirely subcutaneous Burke, S-ICD, HRS 2012, Boston, MA CE Mark Approved. Caution: S-ICD is an investigational device limited to investigational use only under US federal law. Not for sale.

15 15 15 Ideal Device Placement

16 93% Smaller than Traditional Pacemakers 2 grams 0.8 cc

17 Primary Results Published in The New England Journal of Medicine

18 Conclusions The transcatheter ventricular pacemaker was successfully implanted (99.2%) in clinically diverse patients around the world, while meeting the prespecified long-term safety endpoint. Major complications occurred in 4% of patients, 48% less than the transvenous pacemaker control group, and all sub-groups fared better with the leadless pacemaker. Importantly, this resulted in 47% fewer hospitalizations and 82% fewer system revisions, led by the elimination of pneumothoraces and absence of leadless dislodgements. Pacing thresholds remained low and stable through 12 months.

19 Bridge Balloon to save lives in lead extraction procedures Bridge balloon to occlude SVC when tears occur due to lead extraction 11/11 saves when deployed since approved!! 50% expected death rate in SVC tears.