Leadless and Subcutaneous Pacemakers and ICDs Where Are We Now and - - PDF document

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Leadless and Subcutaneous Pacemakers and ICDs Where Are We Now and - - PDF document

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Leadless and Subcutaneous Pacemakers and ICDs Where Are We Now and What Is the Future? Byron K. Lee MD Professor of Medicine Samuel T. and Elizabeth Webb Reeves Endowed Chair Director of the EP Labs and Clinics University of California, San

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UCSF

Cardiac Electrophysiology

Leadless and Subcutaneous Pacemakers and ICDs

Where Are We Now and What Is the Future?

Byron K. Lee MD Professor of Medicine Samuel T. and Elizabeth Webb Reeves Endowed Chair Director of the EP Labs and Clinics University of California, San Francisco 36th Annual Advances in Heart Disease San Francisco, CA December 2019

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¡Biotelemetry

§ Consulting-Moderate

¡Biotronik

§ Consulting-Moderate

¡Boston Scientific

§ Research Support- Significant

¡Medtronic

§ Research Support- Significant

¡Zoll Medical

§ Honorarium-Significant

DISCLOSURES

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1952 Paul Zoll: closed chest pacing Early 1950s Furman & Robinson: intracardiac pacing 1957 Earl Bakken: wearable battery powered pacemaker 1958 Rune Elmqvist & Ake Senning: implantable pacemaker

PACING HISTORY

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The first pacemaker used at Mount Zion in 1957 built from spare parts

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1958 FIRST PPM PATIENT: ARNE LARSSON

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http://www.21stcentech.com/wp- content/uploads/2013/10/Evolution-of- pacemakers.jpg

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STANDARD TRANSVENOUS PPM

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LEAD INFECTIONS

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LEAD FIBROSIS

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LEAD EXTRACTION

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Maytin et al. Heart 2011

RISK OF LEAD EXTRACTION

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COMPARISON OF LEADLESS CARDIAC PACEMAKERS

Miller MA, Neuzil P, Dukkipati S, Reddy VY. Leadless Cardiac Pacemakers: Back to the Future – JACC 2015 (Nanostim) (Micra)

* Electrogram recording capabilities not available

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N Engl J Med 2015;373:1125-1135

  • 526 pts. with indications for single chamber pacing
  • pre-specified analysis of primary efficacy and safety endpoints at

6 months in first 300 patients.

  • Composite primary efficacy endpoint: therapeutically acceptable

pacing threshold (≤2.0 V at 0.4 ms) and sensing amplitude (R wave ≥ 5.0 mV)

  • Primary safety endpoint: freedom from device related adverse

events through 6 months

  • Primary efficacy and safety endpoints compared to historical

performance goals – 85% and 86%, respectively

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N Engl J Med 2016;374:533-541

  • 725 pts. with indications for single chamber pacing
  • pre-specified analysis of primary efficacy and safety endpoints at

6 months in first 300 patients.

  • Composite primary efficacy endpoint: percentage of pts. with pacing

threshold ≤2.0 V at 0.24 ms and ≤1.5 V increase since implantation

  • Primary safety endpoint: freedom from system-related or procedure-related

major complications

  • Primary efficacy and safety endpoints compared to historical performance

goals – 80% and 83% respectively

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PRIMARY ENDPOINTS

  • Implantation Success: 95.8% (526 pts.)
  • Primary Efficacy Endpoint (300 pts.):
  • 270/300 pts. (90%, 95% CI 86.0-

93.2%, p=0.007)

  • Primary Safety Endpoint (300 pts.):
  • 280/300 pts. (93.3%, 95% CI 89.9-

95.9%, p<0.001)

  • Primary safety endpoint and safety

endpoints exceeded pre-specified historical performance goals.

Leadless II IDE Clinical Trial

Reddy VY et al – N Engl J Med 373:1125-1135 (2015)

  • Implantation Success: 99.2% (725

pts.)

  • Primary Efficacy Endpoint (300 pts.):
  • 98.3% (95% CI 96.1-99.5%,

p<0.001)

  • Primary Safety Endpoint (300 pts.):
  • 96.0% (95% CI 93.9-97.3%,

p<0.001)

  • Primary safety endpoint and safety

endpoints exceeded pre-specified historical performance goals.

Reynolds D et al – N Engl J Med 2016;374:533-541

Micra IDE Clinical Trial

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NANOSTIM/ST JUDE/ABBOTT LEADLESS PPM CE Mark approval in 2013 Halted in October 2016

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MEDTRONIC LEADLESS PPM

CE Mark approval in 2015 FDA approval in April 2016

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Heart Rhythm July 2018

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Heart Rhythm July 2018

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Heart Rhythm July 2018

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Heart Rhythm September 2018

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Heart Rhythm September 2018

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Retrieval of LCP

  • Short-term retrieval of LCPs have been shown to be possible –

Nanostim LCP successfully retrieved in 94% (15/16 pts.) up to 1188 days post-implant (Reddy VY et al - HRS Scientific Sessions 2016)

  • Long-term unknown: may need to be abandoned with

placement of new device – age of patient should be considered

Encapsulated Nanostim device at approx. 1 year

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HRS/ACCF EXPERT CONSENSUS STATEMENT ON PACEMAKER DEVICE AND MODE SELECTION

Gillis AM et al – Heart Rhythm 2012;9:1344-65

Leadless pacemaker

Estimated to be suitable for 15% of patients needing pacemakers

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HISTORY OF ICD THERAPY

¡ 1966 – Conception ¡ 1969 – First experimental model ¡ 1975 -- First animal implant ¡ 1980 -- First human implant ¡ 1985 -- FDA approval

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¡“…fraught with a multitude of technical difficulties…” ¡“… possible immediate and delayed deleterious effects on the myocardium…. ¡“…unnecessary shocks…” ¡“…the [rationale for] some electronic gadget manufacture [is]: ‘It was developed because it was possible.’”

Lown B and Axelrod P. Circulation 1972; 46(4): 637

There was initial resistance to the idea…

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¡ “...absence of a method for testing… Even in this age of derring-do and erosion of ethical constraints, it is unlikely that VF will be induced deliberately to ascertain performance.” ¡ “…for whom is such a device intended?” ¡ “There is serious question whether an indication can be spelled out for the use of an implanted standby defibrillator” ¡ “If no indications can be clearly defined, why dissipate scarce health resources?”

There was initial resistance to the idea…

Lown B and Axelrod P. Circulation 1972; 46(4): 637

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…AND SPIRITED RESPONSE…

¡ “Fortunately, Dr. Lown’s findings of myocardial damage due to transthoracic DC electroshock have not led to [its abandonment] by the medical profession.” ¡ “…we do not foresee difficulties in identifying populations at particularly high risk of dying from VF.”

Moss AJ. Circulation 1973; 47: 1135 Mirowski M et al. Circulation 1973; 47: 1135

  • “Are Drs. Lown and Axelrod so clairvoyant that they can see the

innate impractability of someone else’s research energies…?”

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¡Abdominal implant ¡High DFT ¡SVC thrombosis ¡Lead fracture ¡Insulation breakdown ¡Retraction of coil

1980: ORIGINAL MIROWSKI AID

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STANDARD TRANSVENOUS ICD

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BOSTON SCIENTIFIC “LEADLESS” S-ICD

FDA approved in Sept 2012

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JACC November 2016

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JACC November 2016

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JACC November 2016

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JACC November 2016

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JACC EP December 2017

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JACC EP December 2017

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22 YO WOMAN WITH ARVC AND VT

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22 YO WOMAN WITH ARVC AND VT

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SQ-ICD PATIENT SELECTION

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CAST TRIAL

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CAST TRIAL

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WHI TRIAL

WHI Investigators et al. JAMA 2002

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WHI TRIAL

WHI Investigators et al. JAMA 2002

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EMBRYONIC STEM CELL RESEARCH

Gepstein et al. Discovery 2009

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¡ Leadless pacemakers

§ Appear effective in the short and intermediate term § Higher risk of perforation and death § Lower risk of lead and other long term complications (so far)

¡ Subcutaneous ICDs

§ Appear effective long term § Less lead complications offset by more non-lead complications § More inappropriate shocks are due to oversensing rather than SVTs ¡ No RCTs showing superiority or equivalence to conventional pacemakers and ICDs

CONCLUSIONS

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