What question did this study set out to answer?

To determine whether adding a single-element subcutaneous array electrode to a standard transvenous defibrillator lead configuration lowers the defibrillation threshold and enlarges the defibrillation field.

December 1, 1998Pacing and Clinical Electrophysiology

Effect of a Single Element Subcutaneous Array Electrode Added to a Transvenous Electrode Configuration on the Defibrillation Field and the Defibrillation Threshold

Q: What is the clinical evidence from this study?

Study design: RCT. Population: Patients requiring defibrillation (n=20). Intervention: Combination of transvenous lead and single element subcutaneous array lead vs. Transvenous lead system alone. Primary outcome: Mean defibrillation threshold (p=0.0001).

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Key result

Adding a single element subcutaneous array lead to a transvenous lead system significantly lowered the mean defibrillation threshold compared to the transvenous system alone (5.7 vs 9.5 J; P=0.0001).

Why the study?

Does adding a single element subcutaneous array lead to a transvenous lead system reduce the defibrillation threshold in patients receiving an ICD?

Population

20 consecutive patients undergoing ICD implantation

Comparison

Single element subcutaneous array lead added to… vs Transvenous lead system alone

Design

RCT, Patients were randomized as to whether to start them with the transvenous…

Follow-up

15.8 +/- 2 months

Authors

VKVolker KühlkampUniversity of Tübingen VDV. DörnbergerBG Klinik Tübingen KKKOUROSH KHALIGHIKlinikum Ingolstadt

Discussion

Member takes

Implication

Supports adjunctive subcutaneous array leads to optimize transvenous ICD defibrillation; extends randomized evidence for lead configuration strategies.

Key Points

To determine whether adding a single-element subcutaneous array electrode to a standard transvenous defibrillator lead configuration lowers the defibrillation threshold and enlarges the defibrillation field.
Enrolled 20 consecutive patients who received an additional single-element subcutaneous array lead alongside a transvenous lead system using a single infraclavicular incision.
Randomized patients to begin testing with either the transvenous configuration alone or the combined transvenous and subcutaneous configuration.
Determined biphasic defibrillation thresholds using a binary search protocol intraoperatively, at 1 week, 3 months, and 12 months, and measured interelectrode area using biplane chest radiography.
The mean defibrillation threshold was significantly lower with the additional subcutaneous lead (5.7 ± 2.9 J) compared to the transvenous system alone (9.5 ± 4.6 J; P = 0.0001).
High-voltage circuit impedance decreased from 48.9 ± 7.4 Ω to 39.2 ± 5.0 Ω, while interelectrode area increased by 11.3% ± 5.5% in the frontal plane (P < 0.0001) and by 29.5% ± 12.4% in the lateral plane (P < 0.0001).
Defibrillation thresholds remained stable through 12 months, with zero subcutaneous electrode-related complications observed over a follow-up of 15.8 ± 2 months.

Study Design

Type

RCT (n=20)

Randomization

Randomized sequence

Structured PICO

Does adding a single element subcutaneous array lead to a transvenous lead system reduce the defibrillation threshold in patients receiving an ICD?

Population

20 consecutive patients undergoing defibrillation threshold testing with transvenous and subcutaneous leads, followed for a mean of 15.8 months.

Intervention

Single element subcutaneous array lead added to a transvenous lead system (right ventricular and vena cava superior lead)

Comparator

Transvenous lead system alone

Outcome

Biphasic defibrillation thresholdsurrogate

Main Result

Absolute Event Rate: 5.7% vs 9.5%

p-value: p=0.0001

Adding a single element subcutaneous array lead to a transvenous ICD lead system significantly lowers the defibrillation threshold and impedance without increasing complications.

Cite This Study

Kühlkamp et al. (1998) conducted an RCT in Patients requiring defibrillation (n=20). Combination of transvenous lead and single element subcutaneous array lead vs. Transvenous lead system alone was evaluated on Mean defibrillation threshold (p=0.0001). Adding a single element subcutaneous array lead to a transvenous lead system significantly lowered the mean defibrillation threshold compared to the transvenous system alone (5.7 vs 9.5 J; P=0.0001).

synapsesocial.com/papers/6a9d96cb612f7f644148b62c https://doi.org/10.1111/j.1540-8159.1998.tb00036.x

Topics

Ventricular arrhythmias Cardiac device therapy

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Implication

Supports adjunctive subcutaneous array leads to optimize transvenous ICD defibrillation; extends randomized evidence for lead configuration strategies.

Effect of a Single Element Subcutaneous Array Electrode Added to a Transvenous Electrode Configuration on the Defibrillation Field and the Defibrillation Threshold

Discussion

Member takes

Implication

Key Points

Study Design

Structured PICO

Main Result

Cite This Study

Topics

Effect of a Single Element Subcutaneous Array Electrode Added to a Transvenous Electrode Configuration on the Defibrillation Field and the Defibrillation Threshold

Discussion

Member takes

Implication

Key Points

Study Design

Structured PICO

Main Result

Cite This Study

Also Consider

Topics

Also Consider