Lead Management and Extraction

Highlighted products for this procedure

TightRail Mechanical Rotating Dilator Sheath

With TightRail, flexibility meets unparalleled control. The tool’s flexible shaft helps physicians remain coaxial to the lead while maintaining forward progression through tortuous vasculature. The dilating blade remains shielded until activated, putting physicians in control and allowing counter-traction at the targeted lead’s distal tip.

Discover more TightRail features

View the TightRail family of tools

Bridge Occlusion Balloon

A tear in the superior vena cava (SVC) during a lead extraction procedure is rare, occurring in just 0.5% of cases.³ But when a tear does occur, the Bridge occlusion balloon can be quickly deployed to stop blood loss and allow time for transition to surgical repair.⁴

Investigate the life-saving design of Bridge Occlusion Balloon

View the lead extraction portfolio of tools

At our institution Bridge is standard of care. Everyone knows that if we start a high-risk procedure, we are going to prophylactically use Bridge. It is a mandatory step."

Raul Weiss

MD

Improved patient outcomes with Philips’ Lead Management portfolio of safe and effective tools

Lead extraction for CIED infection can be a life-saving procedure. Yet, over 65% of CIED infection patients are treated inappropriately⁶. Any patient with a CIED and an infection should be referred quickly for a lead extraction consultation, as data shows delaying lead extraction can lead to mortality.^6-7

Also, >80% of patients with a noninfectious indication for lead extraction have their leads capped and abandoned.⁸ The risks of capping a lead include the increased risk of infection,⁸ worse outcomes and increased difficulty of a future extraction,⁸ increased risk of venous occlusion^9-11 and MRI contraindication.^12-13 Lead extraction has a 99.72% procedural safety rate¹⁴ and a 97.7% clinical success rate.¹⁴ Capping and abandoning leads poses significant risks that can be mitigated proactively with safe lead extraction¹⁵. It is an HRS Class I indication for physicians and patients to discuss the risks of lead abandonment and the risks of lead extraction.⁵

Philips is dedicated to helping physicians and patients manage every lead – safely, responsibly, predictably.

88.2%

SVC tear survival rate

A multi-year study showed proper Bridge utilization increased SVC tear survival from 56.4% to 88.2%³

99.7%

Procedural safety rate¹⁴

97.7%

Clinical success rate¹⁴

2017 HRS expert consensus statement on cardiovascular implantable electronic device lead managment and extraction⁵.

Read full expert statement (3.68MB)

Lead Extraction in the contemporary setting: The LExICon study. An observational retrospective study of consecutive laser lead extraction¹⁴.

Read study (258.0KB)

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Atrial fibrillation procedures

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Disclaimer

Product availability is subject to country regulatory clearance. Please contact your local sales representative to check the availability in your country.

References

¹ Comparison of average peak push forces required to advance Laser Sheath at 40 Hz vs. 80 Hz Pulse Repetition Rate through simulated fibrosis material at an advancement rate of 1.0 mm/second. D015722, Data on file at Philips.

² Comparison of ablation force vs. advancement rate of Laser sheath 40Hz vs. 80Hz by use of the data collected in D015786, Data on file at Philips.

³ Carillo RG, Tsang DC, Azarrafiy R, Boyle TA. Multi-Year Evaluation of Compliant. Endovascular Balloon in Treating Superior Vena Cava Tears During Transvenous Lead Extraction. EHRA late-breaking trial. March 19, 2018.

⁴ Document on file, D026197. In an animal model with SVC tears up to 3.5 cm, with 2 pacing leads and 1 ICD lead.

⁵ Kusumoto et al. 2017 HRS Expert Consensus Statement on Cardiovascular. Implantable Electronic Device Lead Management and Extraction. Heart Rhythm, 2017.

⁶ Sohail, M Rizwan, et al. Incidence, Treatment Intensity, and Incremental Annual Expenditures for Patients Experiencing a Cardiac Implantable Electronic Device Infection: Evidence From a Large US Payer Database 1-Year Post Implantation. Circ Arrhythm Electrophysiol. 2016; 9(8).

⁷ Maytin M, Jones SO, Epstein LM. Long-Term Mortality After Transvenous Lead Extraction. Circ Arrhythm Electrophysiol. 2012;5:252-257.

⁸ Pokorney et al. Outcomes Associated with Extraction versus Capping and Abandoning Pacing and De brillator Leads Circulation 2017 Oct 10;136(15):1387-1395. doi: 10.1161/CIRCULATIONAHA.117.027636. Epub 2017 Aug 22.

⁹ Sohail, M. et al. (2014). Laser lead extraction to facilitate cardiac implantable electronic device upgrade and revision in the presence of central venous obstruction. Europace, 16(1), 81-87.

¹⁰ Oginosawa Y, Abe H, Nakashima Y. The incidence and risk factors for venous obstruction after implantation of transvenous pacing leads. Pacing Clin Electrophysiol 2002;25:1605–1611.

¹¹ Kutarski, A., Pietura, R., Młynarczyk, K., Małecka, B., & Głowniak, A. (2012). Pacemaker lead extraction and recapture of venous access: technical problems arising from extensive venous obstruction. Cardiology journal, 19(5), 513-517.

¹² Mattei, E., Gentili, G., Censi, F., Triventi, M. and Calcagnini, G. (2015), Impact of capped and uncapped abandoned leads on the heating of an MR-conditional pacemaker implant. Magn Reson Med, 73: 390–400. doi: 10.1002/mrm.25106

¹³ Kalin R, Stanton MS. Current clinical issues for MRI scanning of pacemaker and defibrillator patients. PACE. April 2005;28(4):326-328.

¹⁴ Wazni, O et. al. Lead Extraction in the Contemporary Setting: The LExICon Study: A Multicenter Observational Retrospective Study of Consecutive Laser Lead Extractions, J Am Coll Cardiol, 55:579-586

¹⁵ de Cock CC, et al. Long-term outcome of patients with multiple (> or = 3) noninfected leads: a clinical and echocardiographic study. PACE, Vol 23, No 4, 2000, 423-6.

GlideLight Laser Sheath

GlideLight Laser Sheath Important Safety Information

Indications for Use

The Laser Sheath is intended for use as an adjunct to conventional lead extraction tools in patients suitable for transvenous removal of chronically implanted pacing or defibrillator leads constructed with silicone or polyurethane outer insulation.

Contraindications

Use of the Laser Sheath is contraindicated:

When emergency thoracotomy with cardiopulmonary bypass cannot be performed immediately in the event of a life threatening complication;
When fluoroscopy is not available;
In patients in whom superior venous approach cannot be used;
When the proximal end of the pacing lead is not accessible to the operator;
When the lead will not fit into the inner lumen of the Laser Sheath.

Potential Adverse Events
The following adverse events or conditions may also occur during lead extraction with the Laser Sheath, but were not observed during the clinical study (listed in alphabetical order): bacteremia, low cardiac output, migration of lead fragments, migration of vegetation, myocardial avulsion/perforation, premature ventricular contractions, pulmonary embolism, stroke, venous avulsion/perforation, ventricular tachycardia.

Caution: Federal law restricts this device to sale by or on the order of a physician.

Lead Management and extraction