Everyone Needs a Device Christopher L. Fellows, MD, FACC, FHRS Virginia Mason Medical Center Seattle, Wa.

Transcription

1 Everyone Needs a Device 2018 Christopher L. Fellows, MD, FACC, FHRS Virginia Mason Medical Center Seattle, Wa.

2 CIED therapy The heart as an electrical organ History of pacing and defibrillation What is available and how do they work programming Indications, who needs a device complications What s new and where are we going

3

4

5

6 Agustus D. Waller ( ) Waller, AD, A Demonstration on Man of Electromotive Changes Accompanying the Heart s Beat J. Physiol 8:229-34,1887.

7 Willem Einthoven

8 Cambridge electrocardiograph built for Sir Thomas Lewis (c. 1910)

9 Albert S. Hyman ( ), The hymanotor 1932

10 October 1933 issue of Popular Science.

11 Paul Zoll used external pacing in patients, 1952

12 th Anniversary of Pacing Arne Dr. Senning Dr. Elmqvist Implanting Physician: Åke Senning, MD Pacemaker Designer / Builder: Rune Elmquist, MD (an Elema founder) Patient: Arne Larsson (an EE, had 22 pacers over 43 yrs until passing away in 2001, at age 86 from a non-cardiac condition)

13

14

15

16 BiV Pacing or Cardiac Resynchronization Therapy ( CRT-P or CRT-D) Morton M. Mower, MD

17 Cardiac resynchronization therapy CRT Stimulation

18 MVO 2 / HR (Relative Units) CRT --decreasing O2 consumption LV Pacing Dobutamine P< dp/dt max (mmhg/s) Nelson GS, Berger RD, Fetics BJ, et al. Left ventricular or biventricular pacing improves cardiac function at diminished energy cost in patients with dilated cardiomyopathy and left bundle-branch block. Circulation. 2000;102:3057.

19 BiV pacer (CRT-P) or BiV ICD (CRT-D) in appropriate patients Decrease mortality Improves functional status Decreases hospitalization There are extensive very complicated appropriate use guidelines

20 Cardiac arrest

21 The Implantable Cardioverter/Defibrillator (ICD) Conception First Experimental Model First Animal Implant First Human Implant FDA Approval Mieczyslaw Michel Mirowski ( )

22

23 Pectoral implant 1993

24

25 S-ICD

26

27

28

29 Programming

30 programmers Are company specific Are very complicated and not intuitive A magnet is not a substitute Crossely GH, et.al. The Heart Rhythm Society (HRS)/American Society of Anesthesiologists (ASA) Expert Consensus Statement on the Perioperative Management of Patients with Implantable Defibrillators, Pacemakers and Arrhythmia Monitors: Facilities and Patient Management. Heart Rhythm, Vol 8, No 7, July 2011.

31 Programming changes prior to surgery? Pre op checks Dependent patients Rate response ICD shocks turned off Post op checks

32 Who needs a pacer?

33

34 The Guidelines Medical Society (ACC/AHA/HRS) guidelines (Evidence based expert consensus opinion for scientific and medical issues) Regulatory guidelines (FDA approval) Reimbursement guidelines (CMS and other) Europe and other countries Often little coordination

35 August 13, 2013, CMS issued a National Coverage Determination (NCD). Documented non-reversible symptomatic bradycardia due to sinus node dysfunction. Documented non-reversible symptomatic bradycardia due to second degree and/or third degree atrioventricular block.

36 The following indications are non-covered Reversible causes of bradycardia Asymptomatic bradycardia Bradycardia during sleep Syncope of undetermined cause AF without symptomatic bradycardia Asymptomatic conduction system disease ( bundle branch block)

37 ICD guidelines.too numerous! 2017 AHA/ACC/HRS Guideline for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death 2014 EHRA/HRS/APHRS Expert Consensus on Ventricular Arrhythmias 2013 Appropriate Use Criteria for Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy 2012 ACCF/AHA/HRS Focused Update of the 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities 2012 EHRA/HRS Expert Consensus Statement on Cardiac Resynchronization Therapy in Heart Failure: Implant and Follow-up Recommendations and Management

38 ICD Guidelines Patients surviving a Cardiac arrest or VT not due to a reversible cause. Patients at high risk for future cardiac arrest or sustained VT, primarily patients with poor heart function not amenable to other therapies.

39 Complications (acute) Hematoma/bleeding Lead dislodgements Pneumothorax Perforations/tamponade infections

40 Complications (chronic) Infection/erosion Lead fracture or dislodgement High pacing thresholds or poor sensing SCV thrombosis/occlusion twiddler

41

42 Where are we going? MRI Remote f/u and Cybersecurity Leadless Implantable monitors Novel devices

43 MRI Device movement Tissue heating and injury Altered sensing/pacing Inhibition of therapy or inappropriate therapy Altered programming

44 MRI Risk/benefit Exclude pacers and ICDs implanted before 2000 Exclude abandon lead and epicardial leads New implants ( < 4 weeks)

45 MRI Reprogram and test pre and post scan Monitor during scan Skilled personnel available during the scan f/u pacer check as an outpatient

46 MRI MRI conditional devices still require reprogramming, skilled personnel in attendance, post scan checks Abandoned leads remain an issue 1) Miller JD, Nazarian S, Halperin HR. Implantable Electronic Cardiac Devices and Compatability the Magnetic Resonance Imaging. J Am Coll Cardiol 2016;68: ) 2017 HRS Expert Consensus Statement on Magnetic Resonance Imaging and Radiation Exposure in Patients with Cardiovascular Implantable Electronic Devices. Heart Rhythm, Vol 14, No 7, July 2017

47 Cybersecurity no reports of device compromise related to the cybersecurity vulnerabilities in implanted devices. According to the advisory issued by the Department of Homeland Security, compromising the security of these devices would require a highly complex attack.

48 Cybersecurity Enhancements Proximity based authorization Encryption of patient data Disallow inappropriate or invalid commands

49 Leadless pacemaker

50 Implantable Loop Recorder (ILR) Implantable Cardiac Monitor (ICM) Circa 1998

51

52

53

54 Implanted devices (ICMs) Syncope Cryptogenic stroke Palpitations AF

55

56

57

58

59