Lead Extraction Experience with High Frequency Excimer Laser TANYANAN TANAWUTTIWAT, M.D.,* DANIEL GALLEGO, M.D.,† and ROGER G. CARRILLO, M.D.† From the *Cardiovascular Division, Department of Medicine, University of Miami Miller School of Medicine, Miami, Florida; and †Cardiothoracic Surgery, Department of Surgery, University of Miami Miller School of Medicine, Miami, Florida
Background: A higher frequency Excimer laser sheath using an 80-Hz pulse repetitive rate was approved by the Food and Drug Administration in April 2012. We reported our initial clinical experience with a high-frequency Excimer laser sheath and compared it with lower-frequency laser sheaths which have been previously used. Methods: In this single center, retrospective cohort study, we evaluated patients who underwent lead extraction from December 2008 to May 2013. Those who underwent lead removal without using a laser sheath or with approaches other than subclavian were excluded. Primary endpoints included total laser time, number of pulses, and complications. Data on clinical characteristics, lead type, indications, and outcomes were prospectively collected and analyzed. Results: A total of 427 patients were included in the study (72.6% male; age 67.9 ± 15.23 years). Lower frequency and higher frequency laser sheaths were used in 315 and 112 patients, respectively. A total of 821 leads were removed with 765 leads (93.2%) extracted using the Excimer laser sheath. Lead age was 5.71 ± 4.96 years. Complete extraction was seen in all patients. A higher-frequency laser sheath was associated with a lower laser time and a lower total number of laser pulses even after adjustments for the number of leads, type of leads, and lead age. In the higher frequency group, mortality rate was 0.9% and minor complication rate was 3.6%. Conclusions: When compared with the lower-frequency laser sheath, the higher-frequency laser sheath requires less laser times and more efficient amount of pulses for lead extraction with comparable success rate. Due to the rarity of major and minor complications, no statistical significance was found between the two groups. (PACE 2014; 00:1–9) transvenous lead extraction, laser Excimer sheath, complications, cardiac implantable electronic devices, device infection
Introduction In the past 20 years, the number of cardiac implantable electronic devices (CIED) increased extensively, with approximately 500,000 devices and a million leads implanted annually
Roger G. Carrillo receives a modest research grant from St. Jude Medical Corp. and receives significant honoraria from Spectranetics, Inc. He participates as a speaker bureau for Medtronic, Inc., St. Jude Medical Corp., and Sorin Group; and serves as consultant/advisory board of Boston Scientific and Sensormatic. Financial Support: None. Conflicts of interest: Tanyanan Tanawuttiwat and Daniel Gallego declare no conflict of interest. Abstract of this paper was accepted for poster presentation at AHA 2013 Scientific Session, November 2013, Dallas, Texas. Address for reprints: Roger G. Carrillo, M.D., F.H.R.S., 1295 NW 14th Street, Suite H, Miami, FL 33136. Fax: 305-689-2865; e-mail: [email protected] Received November 11, 2013; revised February 6, 2014; accepted March 3, 2014. doi: 10.1111/pace.12406
worldwide.1–3 Concurrently, the device infections, including deep pocket and/or lead endocarditis, markedly increased.1–4 Complete removal of all hardware is the recommended treatment to allow antibiotic therapy and immune system to cure the infection.4 CIED-associated infection represents a major indication of lead extractions. Besides infection, the other indications published by the Heart Rhythm Society (HRS) in 2009 are classified in major groups as chronic pain, thrombosis or venous stenosis, and functional and nonfunctional leads.5 These possible indications have widely expanded since 2000.6 This resulted in an increased rate of lead extraction. The techniques and tools of transvenous lead extractions have become more important and have been rapidly developed to enhance success rates and minimize complications. Although manual traction is an effective technique to remove recently implanted leads, chronically implanted leads develop fibrous adhesions around the surrounding structures and require more complex extraction tools. The current technique with
© 2014 Wiley Periodicals, Inc. PACE, Vol. 00
2014
1
TANAWUTTIWAT, ET AL.
locking stylets and sheaths started in 1990.7 Currently, there are various types of sheaths that can be used to perform the procedure, including simple mechanical sheaths, rotating mechanical sheaths, electrosurgical sheaths, and Excimer laser sheaths.8 Excimer laser generators produce pulsed ultraviolet light capable of disintegrating human tissue via photochemical, photothermal, and photomechanical effects9 and have been applied for use in lead removal. The laser sheath fiberoptically delivers the laser energy to the distal end of the sheath to release the lead from the encapsulating fibrotic tissue. In April 2012, the higher frequency R 80-Hz Excimer laser sheath (GlideLight , Spectranectics, Colorado Springs, CO, USA) was Food and Drug Administration (FDA) approved. Bench testing reported by the company suggests that the higher-frequency laser sheaths are associated with decreased force of more than 50% and an increased advancement rate of 60% when compared with lower-frequency laser sheaths, R the 40 Hz (SLS II , Spectranectics).10 Therefore, we report our clinical experience with the laser sheath and compared it with the previous lower frequency laser sheath.
by only one operator who had performed at least 1,000 procedures before the first patient’s procedure included in the study. Lead extraction was performed using a standard stepwise approach in all patients. After dissection of lead from the scar tissue in the pocket, the anchoring sleeves were removed and an active fixation mechanism was retracted, if present. Manual traction was attempted as an initial approach. Subsequently, manual traction with a locking stylet was attempted. In case of excessive fibrosis, an Excimer laser sheath was used. Only one type of laser sheath was used for each individual patient. A laser generator (CVX-300 Excimer laser system, Spectranetics) with a lower-frequency R pulsed sheath (SLS II laser sheath, Spectranetics) emitting 308-nm wavelength at a repetition rate up to 40 Hz was used in the patients who underwent laser lead extraction from December 2008 to April 2012. After May 2012, a higher-frequency R pulsed laser sheath laser sheath (GlideLight , Spectranectics) emitting 308-nm wavelength laser pulses with a repetition rate up to 80 Hz was used. Extraction Outcome The Heart Rhythm Society expert consensus was used to determine procedure outcomes and complications.5 Procedure outcomes were classified as complete, partial success, or failure. Complete success was defined as removal of all lead material. The absence of clinical success was categorized as failure of the procedure. The major and minor complications related to lead extraction were recorded. Complication rate was calculated as the number of complications in relation to the overall number of patients treated. The procedural success rate, complications, and mortality were determined 30 days after the procedure.
Methods Patient Population Eligible patients were retrospectively identified from a database maintained in the University of Miami Hospital. This database included all consecutive patients who underwent lead removal in the institute. Demographics, clinical history, extracted lead, extraction indications, laser time, number of laser pulses, and extraction tools were recorded. Only patients who underwent lead removal by using laser Excimer sheaths, and had the procedure done via subclavian approach, were included in the study. The mechanical lead extraction was not performed in our institute during the period of study. The patients with other approaches were excluded as follows: Group 1. Lower frequency sheath: 14 patients with femoral approach and one patient with transatrial approach and Group 2. Higher frequency sheath: five patients with femoral approaches and one patient with internal jugular approach. The study was approved by the University of Miami Institutional Review Board for retrospective medical records review and performed in accordance with institutional guidelines.
Statistical Analysis Descriptive estimates of the distribution of each clinical and lead characteristic were compared between two groups: higher-frequency versus lower-frequency laser sheaths. Discrete variables were expressed as frequencies with their respective percentages. Continuous variables were presented as mean ± standard deviation (SD). Continuous variables were compared using the Student’s t-test, and categorical variables were compared using the Fisher’s exact test. A P value (P)
Background: A higher frequency Excimer laser sheath using an 80-Hz pulse repetitive rate was approved by the Food and Drug Administration in April 2012. We reported our initial clinical experience with a high-frequency Excimer laser sheath and compared it with lower-frequency laser sheaths which have been previously used. Methods: In this single center, retrospective cohort study, we evaluated patients who underwent lead extraction from December 2008 to May 2013. Those who underwent lead removal without using a laser sheath or with approaches other than subclavian were excluded. Primary endpoints included total laser time, number of pulses, and complications. Data on clinical characteristics, lead type, indications, and outcomes were prospectively collected and analyzed. Results: A total of 427 patients were included in the study (72.6% male; age 67.9 ± 15.23 years). Lower frequency and higher frequency laser sheaths were used in 315 and 112 patients, respectively. A total of 821 leads were removed with 765 leads (93.2%) extracted using the Excimer laser sheath. Lead age was 5.71 ± 4.96 years. Complete extraction was seen in all patients. A higher-frequency laser sheath was associated with a lower laser time and a lower total number of laser pulses even after adjustments for the number of leads, type of leads, and lead age. In the higher frequency group, mortality rate was 0.9% and minor complication rate was 3.6%. Conclusions: When compared with the lower-frequency laser sheath, the higher-frequency laser sheath requires less laser times and more efficient amount of pulses for lead extraction with comparable success rate. Due to the rarity of major and minor complications, no statistical significance was found between the two groups. (PACE 2014; 00:1–9) transvenous lead extraction, laser Excimer sheath, complications, cardiac implantable electronic devices, device infection
Introduction In the past 20 years, the number of cardiac implantable electronic devices (CIED) increased extensively, with approximately 500,000 devices and a million leads implanted annually
Roger G. Carrillo receives a modest research grant from St. Jude Medical Corp. and receives significant honoraria from Spectranetics, Inc. He participates as a speaker bureau for Medtronic, Inc., St. Jude Medical Corp., and Sorin Group; and serves as consultant/advisory board of Boston Scientific and Sensormatic. Financial Support: None. Conflicts of interest: Tanyanan Tanawuttiwat and Daniel Gallego declare no conflict of interest. Abstract of this paper was accepted for poster presentation at AHA 2013 Scientific Session, November 2013, Dallas, Texas. Address for reprints: Roger G. Carrillo, M.D., F.H.R.S., 1295 NW 14th Street, Suite H, Miami, FL 33136. Fax: 305-689-2865; e-mail: [email protected] Received November 11, 2013; revised February 6, 2014; accepted March 3, 2014. doi: 10.1111/pace.12406
worldwide.1–3 Concurrently, the device infections, including deep pocket and/or lead endocarditis, markedly increased.1–4 Complete removal of all hardware is the recommended treatment to allow antibiotic therapy and immune system to cure the infection.4 CIED-associated infection represents a major indication of lead extractions. Besides infection, the other indications published by the Heart Rhythm Society (HRS) in 2009 are classified in major groups as chronic pain, thrombosis or venous stenosis, and functional and nonfunctional leads.5 These possible indications have widely expanded since 2000.6 This resulted in an increased rate of lead extraction. The techniques and tools of transvenous lead extractions have become more important and have been rapidly developed to enhance success rates and minimize complications. Although manual traction is an effective technique to remove recently implanted leads, chronically implanted leads develop fibrous adhesions around the surrounding structures and require more complex extraction tools. The current technique with
© 2014 Wiley Periodicals, Inc. PACE, Vol. 00
2014
1
TANAWUTTIWAT, ET AL.
locking stylets and sheaths started in 1990.7 Currently, there are various types of sheaths that can be used to perform the procedure, including simple mechanical sheaths, rotating mechanical sheaths, electrosurgical sheaths, and Excimer laser sheaths.8 Excimer laser generators produce pulsed ultraviolet light capable of disintegrating human tissue via photochemical, photothermal, and photomechanical effects9 and have been applied for use in lead removal. The laser sheath fiberoptically delivers the laser energy to the distal end of the sheath to release the lead from the encapsulating fibrotic tissue. In April 2012, the higher frequency R 80-Hz Excimer laser sheath (GlideLight , Spectranectics, Colorado Springs, CO, USA) was Food and Drug Administration (FDA) approved. Bench testing reported by the company suggests that the higher-frequency laser sheaths are associated with decreased force of more than 50% and an increased advancement rate of 60% when compared with lower-frequency laser sheaths, R the 40 Hz (SLS II , Spectranectics).10 Therefore, we report our clinical experience with the laser sheath and compared it with the previous lower frequency laser sheath.
by only one operator who had performed at least 1,000 procedures before the first patient’s procedure included in the study. Lead extraction was performed using a standard stepwise approach in all patients. After dissection of lead from the scar tissue in the pocket, the anchoring sleeves were removed and an active fixation mechanism was retracted, if present. Manual traction was attempted as an initial approach. Subsequently, manual traction with a locking stylet was attempted. In case of excessive fibrosis, an Excimer laser sheath was used. Only one type of laser sheath was used for each individual patient. A laser generator (CVX-300 Excimer laser system, Spectranetics) with a lower-frequency R pulsed sheath (SLS II laser sheath, Spectranetics) emitting 308-nm wavelength at a repetition rate up to 40 Hz was used in the patients who underwent laser lead extraction from December 2008 to April 2012. After May 2012, a higher-frequency R pulsed laser sheath laser sheath (GlideLight , Spectranectics) emitting 308-nm wavelength laser pulses with a repetition rate up to 80 Hz was used. Extraction Outcome The Heart Rhythm Society expert consensus was used to determine procedure outcomes and complications.5 Procedure outcomes were classified as complete, partial success, or failure. Complete success was defined as removal of all lead material. The absence of clinical success was categorized as failure of the procedure. The major and minor complications related to lead extraction were recorded. Complication rate was calculated as the number of complications in relation to the overall number of patients treated. The procedural success rate, complications, and mortality were determined 30 days after the procedure.
Methods Patient Population Eligible patients were retrospectively identified from a database maintained in the University of Miami Hospital. This database included all consecutive patients who underwent lead removal in the institute. Demographics, clinical history, extracted lead, extraction indications, laser time, number of laser pulses, and extraction tools were recorded. Only patients who underwent lead removal by using laser Excimer sheaths, and had the procedure done via subclavian approach, were included in the study. The mechanical lead extraction was not performed in our institute during the period of study. The patients with other approaches were excluded as follows: Group 1. Lower frequency sheath: 14 patients with femoral approach and one patient with transatrial approach and Group 2. Higher frequency sheath: five patients with femoral approaches and one patient with internal jugular approach. The study was approved by the University of Miami Institutional Review Board for retrospective medical records review and performed in accordance with institutional guidelines.
Statistical Analysis Descriptive estimates of the distribution of each clinical and lead characteristic were compared between two groups: higher-frequency versus lower-frequency laser sheaths. Discrete variables were expressed as frequencies with their respective percentages. Continuous variables were presented as mean ± standard deviation (SD). Continuous variables were compared using the Student’s t-test, and categorical variables were compared using the Fisher’s exact test. A P value (P)
![[The Excimer laser. II. Initial experiences with the Excimer laser in Lucerne].](/assets/img/hold.png)
