RF Surgical Sponge-Detecting System on the Function of Pacemakers and Implantable Cardioverter Defibrillators

NCT02111980 | Completed Results

• 1 other identifier: 131198
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiomyopathy; Cardiac Arrhythmia; Heart Failure; Chronic Thromboembolic Pulmonary Hypertension

Keywords

CIED; pacemaker; implantable cardioverter defibrillator; ICD; radiofrequency; cardiac device programming; RF sponge detection; RF assure; cardiac internal electronic devices; temporary pacing; pulmonary thromboendarterectomy; pacing interference; Arrhythmia

Outcome Measures

Primary Outcomes (10)

• 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.

  Baseline and 15 minutes

• 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.

  Baseline and 15 minutes

• 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.

  Baseline and 15 minutes

• 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.

  Baseline and 15 minutes

• 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.

  Baseline and 15 minutes

• 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.

  Baseline and 15 minutes

• 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.

  Baseline and 15 minutes

Study Arms (1)

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

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.

RF Assure Scanning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be at least 18 years of age
• Patients must be willing and able to provide consent
• Patients must be eligible for pacemaker/ICD removal or temporary pacemaker

You may not qualify if:

• Pregnancy
• Inability or unwillingness to comply with the protocol
• Medical condition that would limit study participation

Sponsors & Collaborators

• University of California, San Diego: lead
• RF Surgical Systems, Inc.: collaborator

Study Sites (1)

UCSD Sulpizio Cardiovascular Center

La Jolla, California, 92093, United States

Location

Related Publications (5)

• 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.

  PMID: 18589366 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.

  PMID: 18156916 BACKGROUND

• Gawande AA, Studdert DM, Orav EJ, Brennan TA, Zinner MJ. Risk factors for retained instruments and sponges after surgery. N Engl J Med. 2003 Jan 16;348(3):229-35. doi: 10.1056/NEJMsa021721.

  PMID: 12529464 BACKGROUND

• Steelman VM, Alasagheirin MH. Assessment of radiofrequency device sensitivity for the detection of retained surgical sponges in patients with morbid obesity. Arch Surg. 2012 Oct;147(10):955-60. doi: 10.1001/archsurg.2012.1556.

  PMID: 23070411 BACKGROUND

• Steelman VM. Sensitivity of detection of radiofrequency surgical sponges: a prospective, cross-over study. Am J Surg. 2011 Feb;201(2):233-7. doi: 10.1016/j.amjsurg.2010.05.001.

  PMID: 21266216 BACKGROUND

MeSH Terms

Conditions

Cardiomyopathies; Arrhythmias, Cardiac; Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Ulrika Birgersdotter-Green
• Organization: UC San Diego School of Medicine

ubgreen@ucsd.edu

858-657-5310

Study Officials

• Ulrika Birgersdotter-Green, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Cardiac Electrophysiology

Study Record Dates

• First Submitted: April 9, 2014
• First Posted: April 11, 2014
• Study Start: March 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: May 1, 2015
• Last Updated: December 24, 2019
• Results First Posted: December 24, 2019

Record last verified: 2019-12

Locations

US (1)