Evidence map›Paper›PMID 34855036›Full record

ArticleJournal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing2022

Effectiveness of SharpSense™ algorithms in reducing bradycardia and pause detection: real-world performance in Confirm Rx™ insertable cardiac monitor.

Rakesh Gopinathannair, Dhanunjaya Lakkireddy, Muhammad R Afzal, Christopher Piorkowski, Fujian Qu, Fady Dawoud, Kevin Davis, Kyungmoo Ryu, John Ip

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Article in Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.0field-weighted citation impact, top 22% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 10 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 4 institutions in 1 country.

Rakesh GopinathannairKansas City Heart Rhythm Institute, Overland Park, KS, USA. drrakeshg@yahoo.com.ORCID http://orcid.org/0000-0003-4611-3687
Dhanunjaya LakkireddyKansas City Heart Rhythm Institute, Overland Park, KS, USA.
Muhammad R AfzalWexner Medical Center, The Ohio State University Medical Center, Columbus, OH, USA.
Christopher PiorkowskiAbbott, Sylmar, CA, USA.
Fujian QuAbbott, Sylmar, CA, USA.
Fady DawoudAbbott, Sylmar, CA, USA.
Kevin DavisAbbott, Sylmar, CA, USA.
Kyungmoo RyuAbbott, Sylmar, CA, USA.
John IpSparrow Clinical Research Institute, Lansing, MI, USA.
Danaher (United States) · USHeart Rhythm Society · USSparrow Hospital · USThe Ohio State University Wexner Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeSharpSense™ technology is an upgradable software enhancement introduced to the Abbott Confirm Rx™ insertable cardiac monitor (ICM). This study aims to characterize the real-world performance of SharpSense algorithms by comparing device detected pause and bradycardia episodes before and after the SharpSense upgrade.

methodsConfirm Rx devices with at least 90 days monitoring each before and after SharpSense upgrade were included in the study. Bradycardia and pause detections and subcutaneous electrocardiograms (SECGs) within 90 days before and after the upgrade were extracted from Merlin.net™ patient care network for evaluation and adjudicated by expert adjudicators.

resultsA total of 197 devices were included in the analysis. Devices were implanted for syncope (35.0%), atrial fibrillation (32.5%), cryptogenic stroke (16.8%), and other indications including palpitations (15.7%). The SharpSense upgrade significantly reduced the number of bradycardia detections by 86.8% and pause detections by 93.1%. In adjudicated SECGs, the upgrade significantly reduced false positive (FP) bradycardia episodes by 91.5% and FP pause episodes by 82.8%. The percentage of devices with at least one FP episode was reduced from 39 to 20% for bradycardia and from 52 to 35% for pause. The number of devices with FP rate greater than 1 episode per week was reduced from 23 to 8% for bradycardia and from 39 to 20% for pause.

conclusionsIn this real-world performance evaluation, the algorithms incorporated in SharpSense software upgrade in Confirm Rx ICMs substantially reduced false positive bradycardia and pause detections and the number of transmitted SECGs for clinic review.

Indexed as

Atrial FibrillationElectrocardiography, AmbulatoryAlgorithmsBradycardiaHumansSyncopeBradycardiaDiagnosisInsertable cardiac monitorsPause

Identifiers

PMID34855036
OpenAlexW3214994922

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.