What is the clinical evidence from this study?

Study design: Observational. Population: Paroxysmal atrial fibrillation (n=74). Intervention: Zio Patch vs. 24-hour Holter monitor. Primary outcome: Detection of atrial fibrillation episodes (p=<0.0001).

What does this research mean for the field?

Continuous monitoring with the Zio Patch detects significantly more atrial fibrillation events than a 24-hour Holter monitor and prompts a change in clinical management in 28.4% of patients. Novelty: ClaimNovelty.METHODOLOGICAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

What question did this study set out to answer?

To assess the tolerability, diagnostic agreement, and clinical utility of an extended-wear continuous monitoring patch compared to a standard 24-hour Holter monitor in paroxysmal atrial fibrillation.

December 13, 2012Pacing and Clinical ElectrophysiologyOpen Access

Use of a Noninvasive Continuous Monitoring Device in the Management of Atrial Fibrillation: A Pilot Study

Q: What are the key findings of this study?

The Zio Patch allowed significantly longer continuous monitoring than a 24-hour Holter, detecting atrial fibrillation in 18 additional patients (p<0.0001) and prompting a change in clinical management in 28.4% of patients.

Q: What does this research mean for the field?

Continuous monitoring with the Zio Patch detects significantly more atrial fibrillation events than a 24-hour Holter monitor and prompts a change in clinical management in 28.4% of patients. Novelty: ClaimNovelty.METHODOLOGICAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

Q: What question did this study set out to answer?

To assess the tolerability, diagnostic agreement, and clinical utility of an extended-wear continuous monitoring patch compared to a standard 24-hour Holter monitor in paroxysmal atrial fibrillation.

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Key result

Zio Patch linked to ~72% higher AF detection compared to a 24-hour Holter monitor.

P<0.0001
n=74

Why the study?

Does the Zio Patch improve the detection of atrial fibrillation and other arrhythmias compared to a 24-hour Holter monitor in patients with paroxysmal atrial fibrillation?

Population

74 consecutive patients with paroxysmal atrial fibrillation referred for Holter monitoring for detection of…

Comparison

Zio Patch worn for up to 14 days. vs 24-hour Holter monitor worn simultaneously…

Design

Cohort, Investigators reading the Zio Patch were blinded to the reports of the…

Follow-up

mean 10.8 days (range 4-14 days)

Authors

MRMichael A. RosenbergGeneral Cardiology MSMichelle SamuelDalhousie University ATAmit J. ThosaniAllegheny Health Network

Discussion

Member takes

Implication

Extended monitoring may enhance AF detection in paroxysmal cases; leaves open whether it improves clinical outcomes.

Key Points

To assess the tolerability, diagnostic agreement, and clinical utility of an extended-wear continuous monitoring patch compared to a standard 24-hour Holter monitor in paroxysmal atrial fibrillation.
Evaluated 74 consecutive patients referred for paroxysmal atrial fibrillation monitoring at Beth Israel Deaconess Medical Center.
Participants wore a 24-hour Holter monitor and a waterproof Zio Patch simultaneously, with instructions to continue patch monitoring for up to 14 days while interpreting cardiologists remained blinded to Holter results.
During the initial 24 hours, atrial fibrillation burden showed high correlation between Holter (58.4 ± 42.7%) and Zio Patch (54.7 ± 41.2%; r = 0.96, P < 0.0001), with patch monitoring worn for a mean of 10.8 ± 2.8 days (range 4–14 days).
Extended continuous recording detected atrial fibrillation episodes in 18 additional patients (P < 0.0001) and altered the documented clinical pattern of atrial fibrillation in 21 patients.
Detection of clinically relevant cardiac events after the first 24 hours led to medication changes or pacemaker referrals, modifying clinical management in 28.4% of patients.

Study Design

Type

Observational (n=74)

Blinding

Single-blind

Multicenter

Structured PICO

Does the Zio Patch improve the detection of atrial fibrillation and other arrhythmias compared to a 24-hour Holter monitor in patients with paroxysmal atrial fibrillation?

Population

74 patients with paroxysmal atrial fibrillation referred for Holter monitoring, who wore both a 24-hour Holter and a continuous monitoring patch for up to 14 days.

Intervention

Zio Patch (single-use, noninvasive waterproof long-term continuous monitoring patch) worn for up to 14 days.

Comparator

24-hour Holter monitor worn simultaneously during the first 24 hours.

Outcome

Detection of atrial fibrillation events and estimation of atrial fibrillation burden.surrogate

Main Result

Absolute Event Rate: 43% vs 25%

p-value: p=<0.0001

Extended continuous ambulatory monitoring with the Zio Patch significantly improved the detection of atrial fibrillation and other arrhythmias compared to a standard 24-hour Holter, leading to meaningful changes in clinical management in over a quarter of patients.

Limitations

Single-center pilot study
Small sample size
Lack of real-time detection inherent in the Zio Patch monitoring

Cite This Study

Rosenberg et al. (2012) conducted an observational in Paroxysmal atrial fibrillation (n=74). Zio Patch vs. 24-hour Holter monitor was evaluated on Detection of atrial fibrillation episodes (p=<0.0001). The Zio Patch allowed significantly longer continuous monitoring than a 24-hour Holter, detecting atrial fibrillation in 18 additional patients (p<0.0001) and prompting a change in clinical management in 28.4% of patients.

synapsesocial.com/papers/6a17c37daeefdf6d9c12f2b2 https://doi.org/10.1111/pace.12053

Topics

Atrial fibrillation Persistent AF management AF ablation outcomes

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Use of a Noninvasive Continuous Monitoring Device in the Management of Atrial Fibrillation: A Pilot Study

Discussion

Member takes

Implication

Key Points

Study Design

Structured PICO

Main Result

Limitations

Cite This Study

Topics

Use of a Noninvasive Continuous Monitoring Device in the Management of Atrial Fibrillation: A Pilot Study

Discussion

Member takes

Implication

Key Points

Study Design

Structured PICO

Main Result

Limitations

Cite This Study

Also Consider

Topics

Also Consider