RF Surgical Sponge-Detecting System on the Function of Pa... | NCT02111980

NCT02111980

Status Module

Sponsor/Collaborators Module

Name	Class
RF Surgical Systems, Inc.	INDUSTRY

Oversight Module

Description Module

Brief Summary

If a surgical sponge is mistakenly left inside a patient's body after a surgical procedure, it can cause a serious infection. To prevent this from happening, a new device has been developed that uses radiofrequency (RF) signals to detect the presence of surgical sponges inside the body. The device is now being used routinely to make sure that no sponges are left inside a patient at the end of an operation. However, the RF device has not been implemented in procedures for patients with cardiac implantable electronic devices (CIEDs). While the device is FDA approved for use, there is a theoretical concern that the radiofrequency signals used to detect the sponges will change the settings on the pacemaker or the defibrillator. Changing the settings on a pacemaker might make it pace the heart too quickly or too slowly, while changing the settings on a defibrillator might cause unnecessary shocks or prevent it from shocking the heart if the patient were to have cardiac arrest.

The purpose of this study is to test whether the radiofrequency device used to detect sponges can cause a clinically significant change to the settings on pacemakers and defibrillators. To minimize potential risk, the device will be tested only on patients who are having the pacemaker or defibrillator removed or replaced as part of their regular medical care, either because it is infected or because the battery has worn out. Before the pacemaker or defibrillator is removed, the settings will be carefully and completely recorded and the radiofrequency device will be used to scan the body for sponges as it would be done during normal operation.

After the pacemaker or defibrillator is taken out, the settings will again be recorded and compared to the settings before the scan. In a standard device removal procedure, no clinically significant change in CIED settings would be expected. If a new pacemaker or defibrillator is implanted in the patient, it will not be exposed to the detection device at all. We will also test whether the RF device has any effect on temporary pacemakers that patients may receive after open heart surgery. We plan to perform testing in a total of 50 patients, 40 with permanent pacemakers or defibrillators and 10 with temporary pacemakers.

Detailed Description

Retained surgical items (e.g., sponges, needles, and instruments) are among the most frequently reported medical errors and occur in an estimated 1 in 5000 operations. A retained surgical item frequently causes a serious negative outcome, including re-operation (70-80% of cases), readmission or prolonged hospital stay (30-60% of cases), sepsis (43% of cases), or death (2% of cases). Retained surgical items are classed as "never events" by the Centers for Medicare and Medicaid Services (CMS), and CMS does not reimburse for additional medical care related to the treatment for such a complication.

Sponges are by far the most common retained items and are estimated to account for 50-70% of cases. The standard method to ensure that no sponge is left inside the body is manual counting. Manual counting, however, carries a sensitivity and specificity of only about 77% and 99%, respectively. In one study 62% of retained items were detected after the count was reported as normal. If the manual count suggests that a sponge has been retained, the standard method to detect it is by taking a radiograph. Radiographs, however, are time-consuming and in one large retrospective study failed to detect retained items in 33% of cases. The standard methods of detecting retained surgical sponges are clearly suboptimal.

Radiofrequency (RF) technology has recently been employed to improve the detection of retained surgical sponges. A radiofrequency chip is sewn into the fabric of the sponge, and a circular wand that emits a radiofrequency signal is passed over the patient. The wand also serves as an antenna that detects a return signal from the chip in the sponge. If a chip is detected it triggers an audio and a visual alarm on a console attached to the wand. In a study involving 210 patients, RF detection systems had 100% sensitivity and specificity for detecting retained sponges, even in morbidly obese patients. To minimize human error during the scanning process, a new system has been developed where the patient lies on a mat that emits the RF signal and serves as the antenna. In a separate study involving 203 patients, the system using the RF mat had a sensitivity and specificity of 98.5% and 100% respectively. To carry out these studies, sponges were placed underneath patients in a blinded manner. Although it would seem that RF detection systems are superior to manual counting, it should be emphasized that an RF detection system is not a substitute for manual counting, but rather an adjunct to manual counting. The RF Assure ® Detection System manufactured by RF Surgical System Inc. is now routinely used to detect retained sponges in the operating rooms at the University of California, San Diego (UCSD) and at ~200 other hospitals.

There has been some concern that the radio frequency signals emitted by the RF Assure® device might reprogram the settings on CIED such as pacemakers and internal cardiac defibrillators (ICDs), since CIEDs are commonly programmed remotely using RF signals. For this reason, the technology is not commonly used in surgeries with patients with CIEDs. In vitro testing was done in a controlled setting to assess the compatibility of the RF Surgical Detection Technology with permanent pacemakers and ICDs as well as temporary pacemakers, specifically the Boston Scientific Cognis, St. Jude Medical Promote, and Medtronic Virtuoso devices, finding no interference between the RF Assure® system and these devices. Although anecdotal experience and in vitro testing has indicated that the RF Assure® system does not affect CIEDs, it has not been established whether the RF Assure® system is suitable to use in patients with CIEDs in a clinical setting. The purpose of this study is to determine whether the RF Assure® device actually can reprogram CIEDs or cause them to malfunction when used in routine clinical practice. This question is of particular importance because of the rising number of surgical patients, especially cardiac patients, that have an implanted CIED.

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
RF Assure Scanning	Experimental	The patient's CIED will be interrogated prior to the study to obtain a baseline reading. The patient will be asked to lie down on the RF Assure® Detection Mat with a sponge placed underneath his or her shoulder. The RF Assure® mat and wand will be activated to detect the sponge. The sponge will be removed from underneath the patient's shoulder, and the RF system will be re-activated to obtain a clear reading. The patient's CIED will be re-interrogated to determine if the RF Assure system caused any changes to the CIED parameters or function.	Device: RF Assure Scanning

Interventions

Name	Type	Description	Arm Group Labels	Other Names
RF Assure Scanning	Device	CIED and temporary pacemaker patients will be scanned with RF surgical sponge detection wand and mat as well as with and without the RF sponge. The scanning will only be conducted on the device scheduled for removal. Patients will have device interrogated before and after scanning (for CIEDs) to determine if there have been any clinically significant changes in programming or settings due to scanning with RF technology. Vitals will be monitored and recorded before, during, and after scanning.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pacing Mode Changes Between Permanent Pacemakers (PPMs)/Implantable Cardiac Defibrillators (ICDs) Scanned With RF Assure	The Pacing Mode on the CIED was measured prior to RF scanning (with sponge) and after the scanning (after sponge removal) in order to evaluate if any significant changes in the pacing mode setting resulted. The following CIED modes were evaluated: DDD (dual chamber pacing, sensing, triggered and inhibited mode), VVI (ventricular pacing, sensing, and inhibited mode), DDI (dual pacing, sensing, and inhibited mode), AAI (atrial pacing, sensing, and inhibited mode). The number of patients' device mode switched between these settings was tabulated and is shown in the below table. Multiple post-scan assessments were not made.	Baseline and 15 minutes
Pacing Polarity Changes With Permanent Pacemakers (PPMs)/Implantable Cardiac Defibrillators (ICDs) Scanned With RF Assure	The patient's pacing polarity was measured prior to scanning with sponge and after scanning with sponge via device interrogation. The following pacing polarity measurements were evaluated: right atrium/right ventricle (RA/RV) bipolar polarity, left ventricle (LV) bipolar polarity, and left ventricle (LV) unipolar polarity. Note that not all study patients had LV leads implanted. Multiple post-scan assessments were not made.	Baseline and 15 minutes
Base Rate Measurement Changes With Permanent Pacemakers (PPMs)/Implantable Cardiac Defibrillators (ICDs) Scanned w/ RF Assure	The base rate on patients' devices was measured before scanning with sponge and after RF scanning with sponge. The median was determined and is presented below with standard deviation for both times. Multiple post-scan assessments were not made.	Baseline and 15 minutes
Max Tracking Rate Changes With Permanent Pacemakers (PPMs)/Implantable Cardiac Defibrillators (ICDs) Scanned With RF Assure	The max tracking rate on the CIEDs was measured prior to scanning with the sponge and post scanning with sponge. The max tracking rate is the maximum atrial rate at which a pacemaker will deliver a ventricular pacing stimulus following each sensed atrial beat. Below, the median and standard deviation are presented. Please note that multiple post-scan assessments were not made for any patient.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Ulrika Birgersdotter-Green, MD	University of California, San Diego	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
UCSD Sulpizio Cardiovascular Center		La Jolla	California	92093	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18589366	Background	Cima RR, Kollengode A, Garnatz J, Storsveen A, Weisbrod C, Deschamps C. Incidence and characteristics of potential and actual retained foreign object events in surgical patients. J Am Coll Surg. 2008 Jul;207(1):80-7. doi: 10.1016/j.jamcollsurg.2007.12.047. Epub 2008 May 23.
18156916	Background	Egorova NN, Moskowitz A, Gelijns A, Weinberg A, Curty J, Rabin-Fastman B, Kaplan H, Cooper M, Fowler D, Emond JC, Greco G. Managing the prevention of retained surgical instruments: what is the value of counting? Ann Surg. 2008 Jan;247(1):13-8. doi: 10.1097/SLA.0b013e3180f633be.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	RF Assure Scanning	The patient's CIED was interrogated prior to the study to obtain a baseline reading. The patient was asked to lie down on the RF Assure® Detection Mat with a sponge placed underneath his or her shoulder. The RF Assure® mat and wand were activated to detect the sponge. The sponge was removed, and the RF system was re-activated to obtain a clear reading. The patient's CIED was re-interrogated to determine if the RF Assure system caused any changes to the CIED parameters or function. RF Assure Scanning: CIED and temporary pacemaker patients were scanned with RF surgical sponge detection wand and mat as well as with and without the RF sponge. The scanning was be conducted on the device scheduled for removal. Patients had device interrogated before and after scanning (for CIEDs) to determine if there were any clinically significant changes in programming or settings due to scanning with RF technology. Vitals were monitored and recorded before, during, and after scanning.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

50 patients were enrolled in this trial. Of this population, 20 had pacemakers, 20 had ICDs, and 10 were undergoing temporary pacing during Pulmonary Thromboendarterectomy (PTE) surgery.

Arm/Group Information

ID	Title	Description
BG000	RF Assure Scanning	Cardiac implantable electronic device (CIED) (implantable cardiac defibrillator (ICD) and permanent pacemakers (PPM)) and temporary pacemaker patients (during pulmonary thromboendartectomy (PTE) surgery) were scanned with the Radiofrequency (RF) surgical sponge detection wand and mat as well as with and without the RF sponge. The scanning was conducted on the device scheduled for removal. Patients had device interrogated before and after scanning (for CIEDs) to determine if there were any clinically significant changes in programming or settings due to scanning with RF technology.

Units	Counts
Participants	BG00050

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

50 patients were enrolled in this trial. Of this population, 20 had pacemakers, 20 had ICDs, and 10 were undergoing temporary pacing during Pulmonary Thromboendarterectomy (PTE) surgery.

Mean

Standard Deviation

years

Title

Denominators

Categories

Pacemaker

- ParticipantsBG00020

Title	Measurements
	BG00074.5± 17

ICD

- ParticipantsBG000

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

- ParticipantsBG00050

Title	Measurements
Female	BG00016
Male

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

- ParticipantsBG00050

Title	Measurements
	BG00050

Body Mass Index (BMI)

50 patients were enrolled in this trial. Of this population, 20 had pacemakers, 20 had ICDs, and 10 were undergoing temporary pacing during Pulmonary Thromboendarterectomy (PTE) surgery.

Mean

Standard Deviation

kg/m^2

Title

Denominators

Categories

Pacemaker

- ParticipantsBG00020

Title	Measurements
	BG000

History of Coronary Artery Disease (CAD)

50 patients were enrolled in this trial. Of this population, 20 had pacemakers, 20 had ICDs, and 10 were undergoing temporary pacing during Pulmonary Thromboendarterectomy (PTE) surgery.

Number

participants

Title

Denominators

Categories

Pacemaker

- ParticipantsBG00020

Title	Measurements
	BG000

History of Atrial Fibrillation (AF)

50 patients were enrolled in this trial. Of this population, 20 had pacemakers, 20 had ICDs, and 10 were undergoing temporary pacing during Pulmonary Thromboendarterectomy (PTE) surgery.

Number

participants

Title

Denominators

Categories

Pacemaker

- ParticipantsBG00020

Title	Measurements
	BG000

History of Diabetes Mellitus (DM)

50 patients were enrolled in this trial. Of this population, 20 had pacemakers, 20 had ICDs, and 10 were undergoing temporary pacing during Pulmonary Thromboendarterectomy (PTE) surgery.

Number

participants

Title

Denominators

Categories

Pacemaker

- ParticipantsBG00020

Title	Measurements
	BG000

History of Hypertension (HTN)

50 patients were enrolled in this trial. Of this population, 20 had pacemakers, 20 had ICDs, and 10 were undergoing temporary pacing during Pulmonary Thromboendarterectomy (PTE) surgery.

Number

participants

Title

Denominators

Categories

Pacemaker

- ParticipantsBG00020

Title	Measurements
	BG000

Measured Ejection Fraction (EF) (%)

50 patients were enrolled in this trial. Of this population, 20 had pacemakers, 20 had ICDs, and 10 were undergoing temporary pacing during Pulmonary Thromboendarterectomy (PTE) surgery.

Mean

Standard Deviation

percentage

Title

Denominators

Categories

Pacemaker

- ParticipantsBG00020

Title	Measurements
	BG000

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Pacing Mode Changes Between Permanent Pacemakers (PPMs)/Implantable Cardiac Defibrillators (ICDs) Scanned With RF Assure

The Pacing Mode on the CIED was measured prior to RF scanning (with sponge) and after the scanning (after sponge removal) in order to evaluate if any significant changes in the pacing mode setting resulted. The following CIED modes were evaluated: DDD (dual chamber pacing, sensing, triggered and inhibited mode), VVI (ventricular pacing, sensing, and inhibited mode), DDI (dual pacing, sensing, and inhibited mode), AAI (atrial pacing, sensing, and inhibited mode). The number of patients' device mode switched between these settings was tabulated and is shown in the below table. Multiple post-scan assessments were not made.

The PTE participants were not included in this analysis because temporary devices do not have capabilities for interrogation (ie: recording pacing mode changes).

Posted

Number

participants

Baseline and 15 minutes

ID	Title	Description
OG000	Pre-Scan Measures for PPM/ICDs Scanned With RF Assure	The patient's CIED was interrogated prior to the study to obtain a baseline reading. The patient was asked to lie down on the RF Assure® Detection Mat with a sponge placed underneath his or her shoulder. The RF Assure® mat and wand were activated to detect the sponge. The sponge was removed, and the RF system was re-activated to obtain a clear reading. The patient's CIED was re-interrogated to determine if the RF Assure system caused any changes to the CIED parameters or function. RF Assure Scanning: CIED and temporary pacemaker patients were scanned with RF surgical sponge detection wand and mat as well as with and without the RF sponge. The scanning was be conducted on the device scheduled for removal. Patients had device interrogated before and after scanning (for CIEDs) to determine if there were any clinically significant changes in programming or settings due to scanning with RF technology. Vitals were monitored and recorded before, during, and after scanning.
OG001	Post-Scan Measures for PPM/ICDs Scanned With RF Assure	The patient's CIED was interrogated prior to the study to obtain a baseline reading. The patient was asked to lie down on the RF Assure® Detection Mat with a sponge placed underneath his or her shoulder. The RF Assure® mat and wand were activated to detect the sponge. The sponge was removed, and the RF system was re-activated to obtain a clear reading. The patient's CIED was re-interrogated to determine if the RF Assure system caused any changes to the CIED parameters or function.

Units	Counts
Participants	OG00040 OG00140

Title

Denominators

Categories

Pacing Mode - DDD

Title	Measurements
	OG00029 OG00129

Pacing Mode - VVI

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		t-test, 2 sided		1.0														Superiority or Other (legacy)

Primary

Pacing Polarity Changes With Permanent Pacemakers (PPMs)/Implantable Cardiac Defibrillators (ICDs) Scanned With RF Assure

The patient's pacing polarity was measured prior to scanning with sponge and after scanning with sponge via device interrogation. The following pacing polarity measurements were evaluated: right atrium/right ventricle (RA/RV) bipolar polarity, left ventricle (LV) bipolar polarity, and left ventricle (LV) unipolar polarity. Note that not all study patients had LV leads implanted. Multiple post-scan assessments were not made.

The PTE participants were not included in this analysis because temporary devices do not have capabilities for interrogation (ie: recording pacing polarity changes).

Posted

Number

participants

Baseline and 15 minutes

ID	Title	Description
OG000	Pre-Scan Measures for PPM/ICDs Scanned With RF Assure	The patient's CIED was interrogated prior to the study to obtain a baseline reading. The patient was asked to lie down on the RF Assure® Detection Mat with a sponge placed underneath his or her shoulder. The RF Assure® mat and wand were activated to detect the sponge. The sponge was removed, and the RF system was re-activated to obtain a clear reading. The patient's CIED was re-interrogated to determine if the RF Assure system caused any changes to the CIED parameters or function. RF Assure Scanning: CIED and temporary pacemaker patients were scanned with RF surgical sponge detection wand and mat as well as with and without the RF sponge. The scanning was be conducted on the device scheduled for removal. Patients had device interrogated before and after scanning (for CIEDs) to determine if there were any clinically significant changes in programming or settings due to scanning with RF technology. Vitals were monitored and recorded before, during, and after scanning.

Primary

Base Rate Measurement Changes With Permanent Pacemakers (PPMs)/Implantable Cardiac Defibrillators (ICDs) Scanned w/ RF Assure

The base rate on patients' devices was measured before scanning with sponge and after RF scanning with sponge. The median was determined and is presented below with standard deviation for both times. Multiple post-scan assessments were not made.

The PTE temporary pacing participants were not included in this analysis because temporary devices do not have capabilities for interrogation (ie: recording base rate measurement changes).

Posted

Median

Standard Deviation

bpm

Baseline and 15 minutes

ID	Title	Description
OG000	Pre-Scan Measures for PPM/ICDs Scanned With RF Assure	The patient's CIED was interrogated prior to the study to obtain a baseline reading. The patient was asked to lie down on the RF Assure® Detection Mat with a sponge placed underneath his or her shoulder. The RF Assure® mat and wand were activated to detect the sponge. The sponge was removed, and the RF system was re-activated to obtain a clear reading. The patient's CIED was re-interrogated to determine if the RF Assure system caused any changes to the CIED parameters or function. RF Assure Scanning: CIED and temporary pacemaker patients were scanned with RF surgical sponge detection wand and mat as well as with and without the RF sponge. The scanning was be conducted on the device scheduled for removal. Patients had device interrogated before and after scanning (for CIEDs) to determine if there were any clinically significant changes in programming or settings due to scanning with RF technology. Vitals were monitored and recorded before, during, and after scanning.

Primary

Max Tracking Rate Changes With Permanent Pacemakers (PPMs)/Implantable Cardiac Defibrillators (ICDs) Scanned With RF Assure

The max tracking rate on the CIEDs was measured prior to scanning with the sponge and post scanning with sponge. The max tracking rate is the maximum atrial rate at which a pacemaker will deliver a ventricular pacing stimulus following each sensed atrial beat. Below, the median and standard deviation are presented. Please note that multiple post-scan assessments were not made for any patient.

34 of 40 participants' Max Tracking Rate was measured. 6 MTRs were not measured or unable to be measured during testing. The PTE temporary pacing participants were not included in this analysis because temporary devices do not have capabilities for interrogation (ie: recording max tracking rate changes).

Posted

Median

Standard Deviation

bpm

Baseline and 15 minutes

ID	Title	Description
OG000	Pre-Scan Measures for PPM/ICDs Scanned With RF Assure	The patient's CIED was interrogated prior to the study to obtain a baseline reading. The patient was asked to lie down on the RF Assure® Detection Mat with a sponge placed underneath his or her shoulder. The RF Assure® mat and wand were activated to detect the sponge. The sponge was removed, and the RF system was re-activated to obtain a clear reading. The patient's CIED was re-interrogated to determine if the RF Assure system caused any changes to the CIED parameters or function. RF Assure Scanning: CIED and temporary pacemaker patients were scanned with RF surgical sponge detection wand and mat as well as with and without the RF sponge. The scanning was be conducted on the device scheduled for removal. Patients had device interrogated before and after scanning (for CIEDs) to determine if there were any clinically significant changes in programming or settings due to scanning with RF technology. Vitals were monitored and recorded before, during, and after scanning.

Primary

Atrio-ventricular (AV) Delay Changes With Permanent Pacemakers (PPMs)/Implantable Cardiac Defibrillators (ICDs) Scanned With RF Assure

The atrio-ventricular delay was measured prior to scanning with sponge and post RF scanning with sponge. Please note that multiple post-scan assessments were not made for any of the patients presented here.

31 patients were evaluated of the 40 in this analysis of the AV Delay 9 paced AV Delays were either not measured or unable to be measured during this study. The PTE participants were not included in this analysis because temporary devices do not have capabilities for interrogation (ie: recording AV Delay Changes).

Posted

Median

Standard Deviation

Baseline and 15 minutes

ID	Title	Description
OG000	Pre-Scan Measures for PPM/ICDs Scanned With RF Assure	The patient's CIED was interrogated prior to the study to obtain a baseline reading. The patient was asked to lie down on the RF Assure® Detection Mat with a sponge placed underneath his or her shoulder. The RF Assure® mat and wand were activated to detect the sponge. The sponge was removed, and the RF system was re-activated to obtain a clear reading. The patient's CIED was re-interrogated to determine if the RF Assure system caused any changes to the CIED parameters or function. RF Assure Scanning: CIED and temporary pacemaker patients were scanned with RF surgical sponge detection wand and mat as well as with and without the RF sponge. The scanning was be conducted on the device scheduled for removal. Patients had device interrogated before and after scanning (for CIEDs) to determine if there were any clinically significant changes in programming or settings due to scanning with RF technology. Vitals were monitored and recorded before, during, and after scanning.

Primary

Battery Capacity Changes With Permanent Pacemakers (PPMs)/Implantable Cardiac Defibrillators (ICDs) Scanned With RF Assure

Of the patients enrolled, battery capacity changes were measured prior to and post RF scanning with sponge. Multiple post-scan assessments were not made for any of the patients presented here.

Of all participants, only 24 were analyzed in this outcome, as their devices reported battery life in millivolts (while other devices reported battery life in % or years). The PTE temporary pacing participants weren't included in this analysis because temporary devices do not have capabilities for interrogation.

Posted

Median

Standard Deviation

Baseline and 15 minutes

ID	Title	Description
OG000	Pre-Scan Measures for PPM/ICDs Scanned With RF Assure	The patient's CIED was interrogated prior to the study to obtain a baseline reading. The patient was asked to lie down on the RF Assure® Detection Mat with a sponge placed underneath his or her shoulder. The RF Assure® mat and wand were activated to detect the sponge. The sponge was removed, and the RF system was re-activated to obtain a clear reading. The patient's CIED was re-interrogated to determine if the RF Assure system caused any changes to the CIED parameters or function. RF Assure Scanning: CIED and temporary pacemaker patients were scanned with RF surgical sponge detection wand and mat as well as with and without the RF sponge. The scanning was be conducted on the device scheduled for removal. Patients had device interrogated before and after scanning (for CIEDs) to determine if there were any clinically significant changes in programming or settings due to scanning with RF technology. Vitals were monitored and recorded before, during, and after scanning.

Primary

Pacing Impedance Changes With Permanent Pacemakers (PPMs)/Implantable Cardiac Defibrillators (ICDs) Scanned With RF Assure

The impedance values of right ventricle (RV), right atrium (RA), and left ventricle (LV) leads was measured prior to RF scanning with sponge and post RF scanning with sponge. Multiple post-scan assessments were not made for any patient represented here.

40 subjects were analyzed. Note that not all had both RA, RV, and LV leads. Therefore, the number of leads (and therefore their impedance values reported below) does not match for each group. The PTE temporary pacing participants were not included in this analysis because temporary devices do not have capabilities for interrogation.

Posted

Median

Standard Deviation

ohms

Baseline and 15 minutes

ID	Title	Description
OG000	Pre-Scan Measures for PPM/ICDs Scanned With RF Assure	The patient's CIED was interrogated prior to the study to obtain a baseline reading. The patient was asked to lie down on the RF Assure® Detection Mat with a sponge placed underneath his or her shoulder. The RF Assure® mat and wand were activated to detect the sponge. The sponge was removed, and the RF system was re-activated to obtain a clear reading. The patient's CIED was re-interrogated to determine if the RF Assure system caused any changes to the CIED parameters or function. RF Assure Scanning: CIED and temporary pacemaker patients were scanned with RF surgical sponge detection wand and mat as well as with and without the RF sponge. The scanning was be conducted on the device scheduled for removal. Patients had device interrogated before and after scanning (for CIEDs) to determine if there were any clinically significant changes in programming or settings due to scanning with RF technology. Vitals were monitored and recorded before, during, and after scanning.

Primary

Shock Impedance Changes With Implantable Cardiac Defibrillators (ICDs) Scanned With RF Assure

The shock impedance changes were measured (right ventricle (RV) coil and superior vena cava (SVC) coil) prior to and post RF scanning with sponge. This was measured by performing a device interrogation in the electrophysiology (EP) lab. Multiple post-scan measurements were not taken for any of the patients presented here.

SVC and RV Coils are specific to ICDs, and therefore, PPMs and Temporary Pacemakers were not included in this analysis.

Posted

Mean

Standard Deviation

ohms

Baseline and 15 minutes

ID	Title	Description
OG000	Pre-Scan Measures for ICDs Scanned With RF Assure	The patient's CIED was interrogated prior to the study to obtain a baseline reading. The patient was asked to lie down on the RF Assure® Detection Mat with a sponge placed underneath his or her shoulder. The RF Assure® mat and wand were activated to detect the sponge. The sponge was removed, and the RF system was re-activated to obtain a clear reading. The patient's CIED was re-interrogated to determine if the RF Assure system caused any changes to the CIED parameters or function. RF Assure Scanning: CIED and temporary pacemaker patients were scanned with RF surgical sponge detection wand and mat as well as with and without the RF sponge. The scanning was be conducted on the device scheduled for removal. Patients had device interrogated before and after scanning (for CIEDs) to determine if there were any clinically significant changes in programming or settings due to scanning with RF technology. Vitals were monitored and recorded before, during, and after scanning.

Primary

Changes in P & R Wave Measurements in Permanent Pacemakers (PPMs)/Implantable Cardiac Defibrillators (ICDs) Scanned With RF Assure

The P and R waves were measured via device interrogation prior to and post RF scanning with sponge. Multiple post-scan measurements were not made for any of the participants represented here.

32 of the 40 participants were evaluated in this study for P and R measurements. 8 patients' devices either didn't have the P or R measured or they was unable to be measured. The PTE temporary pacing participants were not included in this analysis because temporary devices do not have capabilities for interrogation.

Posted

Median

Standard Deviation

Baseline and 15 minutes

ID	Title	Description
OG000	Pre-Scan Measures for PPM/ICDs Scanned With RF Assure	The patient's CIED was interrogated prior to the study to obtain a baseline reading. The patient was asked to lie down on the RF Assure® Detection Mat with a sponge placed underneath his or her shoulder. The RF Assure® mat and wand were activated to detect the sponge. The sponge was removed, and the RF system was re-activated to obtain a clear reading. The patient's CIED was re-interrogated to determine if the RF Assure system caused any changes to the CIED parameters or function. RF Assure Scanning: CIED and temporary pacemaker patients were scanned with RF surgical sponge detection wand and mat as well as with and without the RF sponge. The scanning was be conducted on the device scheduled for removal. Patients had device interrogated before and after scanning (for CIEDs) to determine if there were any clinically significant changes in programming or settings due to scanning with RF technology. Vitals were monitored and recorded before, during, and after scanning.

Primary

Capture Threshold Changes With Permanent Pacemakers (PPMs)/Implantable Cardiac Defibrillators (ICDs) Scanned With RF Assure

Via device interrogation, capture threshold changes (the minimum amount of electricity that the box has to emit to pace the heart) were measured prior to and post RF Scanning with sponge. Multiple post-scan measurements were not taken for any participants presented here.

Because not all devices are equipped with RA, RV, and LV leads, note the population values in the below table for each group: right atrium (RA) thresholds, right ventricle (RV) thresholds, and left ventricle (LV) thresholds. The PTE participants were not included in this analysis because temporary devices do not have capabilities for interrogation.

Posted

Median

Standard Deviation

Baseline and 15 minutes

ID	Title	Description
OG000	Pre-Scan Measures for PPM/ICDs Scanned With RF Assure	The patient's CIED was interrogated prior to the study to obtain a baseline reading. The patient was asked to lie down on the RF Assure® Detection Mat with a sponge placed underneath his or her shoulder. The RF Assure® mat and wand were activated to detect the sponge. The sponge was removed, and the RF system was re-activated to obtain a clear reading. The patient's CIED was re-interrogated to determine if the RF Assure system caused any changes to the CIED parameters or function. RF Assure Scanning: CIED and temporary pacemaker patients were scanned with RF surgical sponge detection wand and mat as well as with and without the RF sponge. The scanning was be conducted on the device scheduled for removal. Patients had device interrogated before and after scanning (for CIEDs) to determine if there were any clinically significant changes in programming or settings due to scanning with RF technology. Vitals were monitored and recorded before, during, and after scanning.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	RF Assure Scanning	The patient's CIED was interrogated prior to the study to obtain a baseline reading. The patient was asked to lie down on the RF Assure® Detection Mat with a sponge placed underneath his or her shoulder. The RF Assure® mat and wand were activated to detect the sponge. The sponge was removed, and the RF system was re-activated to obtain a clear reading. The patient's CIED was re-interrogated to determine if the RF Assure system caused any changes to the CIED parameters or function. RF Assure Scanning: CIED and temporary pacemaker patients were scanned with RF surgical sponge detection wand and mat as well as with and without the RF sponge. The scanning was be conducted on the device scheduled for removal. Patients had device interrogated before and after scanning (for CIEDs) to determine if there were any clinically significant changes in programming or settings due to scanning with RF technology. Vitals were monitored and recorded before, during, and after scanning.			0	50	0	50

ID	Term
D009202	Cardiomyopathies
D001145	Arrhythmias, Cardiac
D006333	Heart Failure

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms