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The purpose of this study is to prospectively evaluate intravascular ultrasound (IVUS) imaging as a tool for grading the presence and characterization of intravascular lead adherence (ILA, or scarring) to cardiovascular implantable electronic device (CIED) leads during transvenous lead extraction (TLE) procedures in a multi-center study. IVUS should identify the location and severity of these adhesions, which the investigators will then correlate to difficulty of the extraction procedure using metrics like pulses of laser energy delivered and time required to traverse an area of fibrosis or ILA. The investigators will be focusing primarily on the section from innominate vein (INNV) down through the superior vena cava (SVC) to the right atrium.
Using IVUS to view blood vessels and the heart structure is approved by the Food and Drug Administration (FDA). Using it as described in this study is off label because of the manner in which it is advanced to the SVC, through the right atrium. While it is not restricted from use in this way, it is not specifically on-label. It should be noted that the use of IVUS during TLE procedures as proposed in this study is routine at the University of Chicago and patients will undergo this procedure regardless of participation in this study. The EP physician team regards the use of IVUS during TLE to be nonsignificant risk.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IVUS imaging | Experimental | IVUS imaging will be used each patient undergoing transvenous lead extraction to visualize ILA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IVUS Imaging | Device | IVUS or radial-ICE (intracardiac echocardiography) is a visualization tool used in many cardiac procedures including electrophysiology procedures (catheter ablation). Its utility in identifying ILA will be assessed in this study. |
| Measure | Description | Time Frame |
|---|---|---|
| IVUS Grades | Operators will be able to successfully grade the degree of intravascular lead adherence (ILA) seen using IVUS imaging. Using the following scale, grading of ILA in each zone of interest, based on relative motion of lead will be performed: i. Grade 1: Freely mobile, Rarely adjacent to vasculature ii. Grade 2: Restricted mobility, Frequently adjacent to vasculature iii. Grade 3: Immobile, Always adjacent to vasculature iv. Grade L, added to number: Lead-to-lead binding | 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Extraction Difficulty Metrics | Operators will record the energy and time necessary to traverse binding sites and will be able to correlate these two metrics to IVUS ILA grade Extraction difficulty was measured by correlating IVUS ILA grade to lead dwell time - the amount of time it took to extract the lead. Using the following scale, grading of ILA in each zone of interest, based on relative motion of lead was performed: i. Grade 1: Freely mobile, Rarely adjacent to vasculature ii. Grade 2: Restricted mobility, Frequently adjacent to vasculature iii. Grade 3: Immobile, Always adjacent to vasculature iv. Grade L, added to number: Lead-to-lead binding |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hemal Nayak, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Chicago | Chicago | Illinois | 60637 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21867833 | Background | Greenspon AJ, Patel JD, Lau E, Ochoa JA, Frisch DR, Ho RT, Pavri BB, Kurtz SM. 16-year trends in the infection burden for pacemakers and implantable cardioverter-defibrillators in the United States 1993 to 2008. J Am Coll Cardiol. 2011 Aug 30;58(10):1001-6. doi: 10.1016/j.jacc.2011.04.033. | |
| 18834475 | Background |
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Enrollment closed across the study due to low enrollment.
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| ID | Title | Description |
|---|---|---|
| FG000 | IVUS Imaging | IVUS imaging will be used each patient undergoing transvenous lead extraction to visualize ILA IVUS Imaging: IVUS or radial-ICE (intracardiac echocardiography) is a visualization tool used in many cardiac procedures including electrophysiology procedures (catheter ablation). Its utility in identifying ILA will be assessed in this study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | IVUS Imaging | IVUS imaging will be used each patient undergoing transvenous lead extraction to visualize ILA IVUS Imaging: IVUS or radial-ICE (intracardiac echocardiography) is a visualization tool used in many cardiac procedures including electrophysiology procedures (catheter ablation). Its utility in identifying ILA will be assessed in this study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | One patient had missing age. |
| 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 | IVUS Grades | Operators will be able to successfully grade the degree of intravascular lead adherence (ILA) seen using IVUS imaging. Using the following scale, grading of ILA in each zone of interest, based on relative motion of lead will be performed: i. Grade 1: Freely mobile, Rarely adjacent to vasculature ii. Grade 2: Restricted mobility, Frequently adjacent to vasculature iii. Grade 3: Immobile, Always adjacent to vasculature iv. Grade L, added to number: Lead-to-lead binding | 3 patients did not have any ILA grades. | Posted | Mean | Standard Deviation | Grade | 6 hours |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IVUS Imaging | IVUS imaging will be used each patient undergoing transvenous lead extraction to visualize ILA IVUS Imaging: IVUS or radial-ICE (intracardiac echocardiography) is a visualization tool used in many cardiac procedures including electrophysiology procedures (catheter ablation). Its utility in identifying ILA will be assessed in this study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Andrew Beaser | University of Chicago | (888) 824-0200 | abeaser@bsd.uchicago.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 15, 2021 | Jan 13, 2023 | Prot_SAP_000.pdf |
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Single cohort of patients undergoing transvenous lead extraction
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| Through study completion, expected to be 6 months |
| Mond HG, Irwin M, Ector H, Proclemer A. The world survey of cardiac pacing and cardioverter-defibrillators: calendar year 2005 an International Cardiac Pacing and Electrophysiology Society (ICPES) project. Pacing Clin Electrophysiol. 2008 Sep;31(9):1202-12. doi: 10.1111/j.1540-8159.2008.01164.x. |
| 28315744 | Background | Joy PS, Kumar G, Poole JE, London B, Olshansky B. Cardiac implantable electronic device infections: Who is at greatest risk? Heart Rhythm. 2017 Jun;14(6):839-845. doi: 10.1016/j.hrthm.2017.03.019. Epub 2017 Mar 16. |
| 28919379 | Background | Kusumoto FM, Schoenfeld MH, Wilkoff BL, Berul CI, Birgersdotter-Green UM, Carrillo R, Cha YM, Clancy J, Deharo JC, Ellenbogen KA, Exner D, Hussein AA, Kennergren C, Krahn A, Lee R, Love CJ, Madden RA, Mazzetti HA, Moore JC, Parsonnet J, Patton KK, Rozner MA, Selzman KA, Shoda M, Srivathsan K, Strathmore NF, Swerdlow CD, Tompkins C, Wazni O. 2017 HRS expert consensus statement on cardiovascular implantable electronic device lead management and extraction. Heart Rhythm. 2017 Dec;14(12):e503-e551. doi: 10.1016/j.hrthm.2017.09.001. Epub 2017 Sep 15. No abstract available. |
| 24315967 | Background | Brunner MP, Cronin EM, Wazni O, Baranowski B, Saliba WI, Sabik JF, Lindsay BD, Wilkoff BL, Tarakji KG. Outcomes of patients requiring emergent surgical or endovascular intervention for catastrophic complications during transvenous lead extraction. Heart Rhythm. 2014 Mar;11(3):419-25. doi: 10.1016/j.hrthm.2013.12.004. Epub 2013 Dec 4. |
| 18958266 | Background | Bracke F. Complications and lead extraction in cardiac pacing and defibrillation. Neth Heart J. 2008 Oct;16(Suppl 1):S28-31. |
| 23510021 | Background | Mazzone P, Tsiachris D, Marzi A, Ciconte G, Paglino G, Sora N, Sala S, Vergara P, Gulletta S, Della Bella P. Predictors of advanced lead extraction based on a systematic stepwise approach: results from a high volume center. Pacing Clin Electrophysiol. 2013 Jul;36(7):837-44. doi: 10.1111/pace.12119. Epub 2013 Mar 19. |
| 22017453 | Background | Maytin M, Epstein LM, John RM. Lead implant duration does not always predict ease of extraction: extraction sheath may be required at < 1 year. Pacing Clin Electrophysiol. 2011 Dec;34(12):1615-20. doi: 10.1111/j.1540-8159.2011.03225.x. Epub 2011 Oct 20. |
| 29784681 | Background | Enriquez A, Saenz LC, Rosso R, Silvestry FE, Callans D, Marchlinski FE, Garcia F. Use of Intracardiac Echocardiography in Interventional Cardiology: Working With the Anatomy Rather Than Fighting It. Circulation. 2018 May 22;137(21):2278-2294. doi: 10.1161/CIRCULATIONAHA.117.031343. |
| 18652009 | Background | Bongiorni MG, Di Cori A, Soldati E, Zucchelli G, Arena G, Segreti L, De Lucia R, Marzilli M. Intracardiac echocardiography in patients with pacing and defibrillating leads: a feasibility study. Echocardiography. 2008 Jul;25(6):632-8. doi: 10.1111/j.1540-8175.2008.00656.x. |
| 28843419 | Background | Sadek MM, Cooper JM, Frankel DS, Santangeli P, Epstein AE, Marchlinski FE, Schaller RD. Utility of intracardiac echocardiography during transvenous lead extraction. Heart Rhythm. 2017 Dec;14(12):1779-1785. doi: 10.1016/j.hrthm.2017.08.023. Epub 2017 Aug 24. |
| 29292119 | Background | Santoshi RKN, Lakhanpal S, Satwah V, Lakhanpal G, Malone M, Pappas PJ. Iliac vein stenosis is an underdiagnosed cause of pelvic venous insufficiency. J Vasc Surg Venous Lymphat Disord. 2018 Mar;6(2):202-211. doi: 10.1016/j.jvsv.2017.09.007. Epub 2017 Dec 29. |
| 27581130 | Background | Ganguli S, Hawkins BM, Abtahian F, Abu-Fadel MS, Walker TG, MacKay C, Jaff MR, Weinberg I. Comparison of Inferior Vena Cava Filters Placed at the Bedside via Intravenous Ultrasound Guidance Versus Fluoroscopic Guidance. Ann Vasc Surg. 2017 Feb;39:250-255. doi: 10.1016/j.avsg.2016.06.013. Epub 2016 Aug 28. |
| 21278179 | Background | Kassavin DS, Constantinopoulos G. The transition to IVUS-guided IVC filter deployment in the nontrauma patient. Vasc Endovascular Surg. 2011 Feb;45(2):142-5. doi: 10.1177/1538574410393753. Epub 2011 Jan 28. |
| 24433783 | Background | Jeyabalan G, Wallace JR, Chaer RA, Leers SA, Marone LK, Makaroun MS. Endovascular strategies for treatment of embolizing thoracoabdominal aortic lesions. J Vasc Surg. 2014 May;59(5):1256-64. doi: 10.1016/j.jvs.2013.11.068. Epub 2014 Jan 14. |
| 15823067 | Background | Di Valentino M, Alerci M, Bogen M, Tutta P, Sartori F, Marty B, von Segesser L, Gallino A. Telementoring during endovascular treatment of abdominal aortic aneurysms: a prospective study. J Endovasc Ther. 2005 Apr;12(2):200-5. doi: 10.1583/04-1421.1. |
| 28411703 | Background | Kolluri R, Fowler B, Ansel G, Silver M. A novel duplex finding of superficial epigastric vein flow reversal to diagnose iliocaval occlusion. J Vasc Surg Venous Lymphat Disord. 2017 May;5(3):358-362. doi: 10.1016/j.jvsv.2017.01.017. |
| 25195955 | Background | Lewis RK, Pokorney SD, Greenfield RA, Hranitzky PM, Hegland DD, Schroder JN, Lin SS, Milano C, Daubert JP, Smith PK, Hurwitz LM, Piccini JP. Preprocedural ECG-gated computed tomography for prevention of complications during lead extraction. Pacing Clin Electrophysiol. 2014 Oct;37(10):1297-305. doi: 10.1111/pace.12485. Epub 2014 Sep 8. |
| 23713912 | Background | Biefer HR, Hurlimann D, Grunenfelder J, Salzberg SP, Steffel J, Falk V, Starck CT. Generator pocket adhesions of cardiac leads: classification and correlation with transvenous lead extraction results. Pacing Clin Electrophysiol. 2013 Sep;36(9):1111-6. doi: 10.1111/pace.12184. Epub 2013 May 28. |
One patient had missing age.
| Count of Participants |
| Participants |
|
| Age, Continuous | One patient had missing age. | Mean | Standard Deviation | years |
|
| Sex: Female, Male | One patient had missing sex. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Body mass index (BMI) | 2 patients did not have data to determine BMI. | Mean | Standard Deviation | kg/m^2 |
|
| Height | One patient had missing height. | Mean | Standard Deviation | cm |
|
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| Secondary | Extraction Difficulty Metrics | Operators will record the energy and time necessary to traverse binding sites and will be able to correlate these two metrics to IVUS ILA grade Extraction difficulty was measured by correlating IVUS ILA grade to lead dwell time - the amount of time it took to extract the lead. Using the following scale, grading of ILA in each zone of interest, based on relative motion of lead was performed: i. Grade 1: Freely mobile, Rarely adjacent to vasculature ii. Grade 2: Restricted mobility, Frequently adjacent to vasculature iii. Grade 3: Immobile, Always adjacent to vasculature iv. Grade L, added to number: Lead-to-lead binding | Means calculated for patients with left sided devices vs patients with right sided devices - 4 patients had missing data | Posted | Mean | Standard Deviation | minutes | Through study completion, expected to be 6 months |
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| 0 |
| 31 |
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| 31 |
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