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May 23, 2013EP Europace

First-in-man implantation of leadless ultrasound-based cardiac stimulation pacing system: novel endocardial left ventricular resynchronization therapy in heart failure patients

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Key result

Implantation of the leadless ultrasound-based WiCS-LV pacing system was feasible in 3 heart failure patients, increasing mean LV ejection fraction from 23.7% to 39% (P<0.017) at 6 months.

Why the study?

Does a leadless ultrasound-based cardiac stimulation pacing system improve LVEF and symptoms in heart failure patients requiring CRT?

Population

3 heart failure patients with NYHA class III-IV and mean LVEF 23.7 ± 3.4%

Design

Case_series

Follow-up

6 months

Authors

AAAngelo AuricchioPDP.-P. DelnoyFRF Regoli

Discussion

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Overview

May inform novel CRT delivery; hypothesis-generating and should not yet change practice.

Study Design

Type

Case Report (n=3)

Structured PICO

Does a leadless ultrasound-based cardiac stimulation pacing system improve LVEF and symptoms in heart failure patients requiring CRT?

P
Population
3 heart failure patients requiring cardiac resynchronization therapy treated with a leadless ultrasound-based pacing system and followed for 6 months.
I
Intervention
Implantation of the WiCS-LV system, a leadless ultrasound-based cardiac stimulation pacing system for left ventricular endocardial resynchronization therapy
O
Outcome
Feasibility, safety, and performance (electrical pacing thresholds, NYHA class, LVEF) at 6 monthssurrogate

Main Result

p-value: p=<0.017

First-in-man implantation of a leadless ultrasound-based LV endocardial pacing system demonstrated feasibility, safety, and short-term improvement in LVEF and symptoms in heart failure patients.

Limitations

  • Findings are yet to be substantiated by larger ongoing studies
  • Small sample size (3 cases)
  • Short-to-mid-term follow-up

Cite This Study

Auricchio et al. (2013) conducted a case report in heart failure (n=3). WiCS-LV system (leadless ultrasound-based cardiac stimulation pacing system) was evaluated on Left ventricular ejection fraction (p=<0.017). Implantation of the leadless ultrasound-based WiCS-LV pacing system was feasible in 3 heart failure patients, increasing mean LV ejection fraction from 23.7% to 39% (P<0.017) at 6 months.

synapsesocial.com/papers/6aa008d2d5d4327e77d55cc3https://doi.org/10.1093/europace/eut124
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Challenges and Solutions for Difficult Implantations of CRT Devices: The Role of New Technology and Techniques2006 · 20 citations
  2. 2Non-contact left ventricular endocardial mapping in cardiac resynchronisation therapy2003 · 145 citations
  3. 3Left Ventricular Endocardial Pacing Improves Resynchronization Therapy in Canine Left Bundle-Branch Hearts2009 · 123 citations
  4. 4Guidelines for cardiac pacing and cardiac resynchronization therapy: The Task Force for Cardiac Pacing and Cardiac Resynchronization Therapy of the European Society of Cardiology. Developed in Collaboration with the European Heart Rhythm Association2007 · 291 citations
  5. 5Results of the Predictors of Response to CRT (PROSPECT) Trial2008 · 2,172 citations