Removal of Active-Fixation Coronary Sinus Leads Using a Mechanical Rotation Extraction Device ALEXANDER KYPTA, M.D., HERMANN BLESSBERGER, M.D., KARIM SALEH, M.D., ¨ ¨ SIMON HONIG, M.D., JURGEN KAMMLER, M.D., and CLEMENS STEINWENDER, M.D. From the Department of Internal Medicine 1 – Cardiology, Linz General Hospital, Johannes Kepler University School of Medicine, Linz, Austria
Background: Active fixation coronary sinus (CS) leads are widely used in cardiac resynchronization therapy (CRT). Due to their low dislodgement rates they are an attractive option for implanters. However, extraction of active fixation leads is a complex procedure that bears potential fatal risks for patients. R (Medtronic Inc., Minneapolis, MN, USA) Methods: We analyzed all patients undergoing StarFix extraction because of severe infection at our institution. Indication for extraction was severe device infection. Procedural outcomes as well as patient characteristics are reported. For removal of the leads R (Cook Intravascular Inc., Leechburg, PA, USA) mechanical rotation extraction sheath a 9-Fr Evolution was used. R leads. One patient Results: Between 2011 and 2014, six patients underwent extraction of StarFix was female, whereas the others were males (mean age 64 ± 12 years). Implant duration was 46.5 ± 8.2 R . In one patient months before removal. All leads could be successfully extracted totally with the Evolution (16.6%) pericardial tamponade occurred immediately requiring surgical intervention. After establishment of cardiopulmonary bypass a 5-mm sharp cut in the lateral vein of the CS could be identified. It was fixed and the patient survived. On all leads, significant tissue growth between the fixation lobes could be observed. R leads implanted years ago can be extracted with Conclusion: As illustrated by our cases, Attain StarFix the help of a mechanical extraction sheath. However, this procedure bears potential risks and should only R be performed with a cardiac surgery standby. If clinicians evaluate the implantation of Attain StarFix leads in patients who are young or at high risk for device infection, they should be aware of these findings. (PACE 2015; 38:302–305) active fixation leads, lead extraction, device infection, resynchronization therapy
Background The success of cardiac resynchronization therapy (CRT) depends predominantly on the location and therefore the initial placement and stability of the coronary sinus (CS) lead. Although CS lead placement has a very high success rate in experienced hands, the risk of lead dislodgement is about 5–10%.1,2 Device manufacturers have developed different shapes of passive leads to keep them in a stable position within the side branch. To minimize the rate of dislodgement and to avoid phrenic nerve stimulation Medtronic released the first active fixation CS lead in August 2008, the Conflicts of interest: None. No sources of funding. Address for reprints: Alexander Kypta, M.D., Department of Internal Medicine I – Cardiology, Linz General Hospital, Johannes Kepler University School of Medicine, Krankenhausstr. 9, 4021 Linz, Austria. Fax: +4373278066205; e-mail: [email protected] Received March 28, 2014; revised September 30, 2014; accepted October 20, 2014. doi: 10.1111/pace.12552
R Attain StarFix 4195 (Medtronic Inc., Minneapolis, MN, USA). It is a 5-Fr unipolar, steroid-eluting lead with an active fixation mechanism consisting of three polyurethane lobes that are deployed by advancing the push tubing around the lead. When deployed, the lobes range from 5 to 24 French in diameter. To date, published data on extraction of these active fixated CS leads are limited to case reports or small series. Our goal was to describe our approach to this kind of extraction in this important patient group.
Methods The General Hospital in Linz is a tertiary referral clinic for pacemaker and defibrillator lead extraction. All extractions as well as patients demographics, comorbidities, device and lead type, reason for extraction, and procedural success were entered into a computer-based recording system. Between November 2011 and January 2014, outcome of six patients undergoing transvenous lead extraction (TLE) of active fixation CS leads were reviewed. Indications for lead extraction were categorized as systemic infection
©2014 Wiley Periodicals, Inc. 302
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ACTIVE FIXATION LEAD EXTRACTION
Table I. Clinical Charcteristics, Extraction Procedure Variables, and Outcomes Duration of Implant Age Sex (Month) 80 47 53 72 64 50
M F M M M M
36.6 43.4 90.7 45.3 47.6 48.1
Indication for Extraction Systemic infection Pocket infection Lead infection Lead infection Lead infection Pocket infection
Procedure EVN in Time Side EVNExtraction Lobes (Min.) Branch Generation Success Retracted 80 60 60 60 120 60
Yes Yes Yes Yes Yes Yes
First First Second Second Second Second
Complete Complete Complete Complete Complete Complete
No No No No No No
Complication Pericardial effusion Tamponade None None None None
R EVN = Evolution .
Table II. Patients’ Comorbidities Pat. 1 Pat. 2 Pat. 3 Pat. 4 Pat. 5 Pat. 6 Age CAD Dilat. CMP A. Fib. Diabetes HTN COPD Renal Dis. EF%
80 + + + + + − − 40
47 − + − − − + − 50
53 − + − − − − − 20
72 − + − + + − + 20
64 + − − − + − − 30
50 − + − − − − − 25
CAD = coronary artery disease; Dilat. CMP = dilatative cardiomyopathy; A. Fib. = atrial fibrillation; COPD = chronic obstructive pulmonary disease; Renal Dis. = renal disease; EF = ejaction fraction.
(elevated inflammatory lab parameters, positive blood cultures), pocket infection with local signs of inflammation (calor, rubor, tumor, dolor), or lead infection (elevated inflammatory lab parameters, visualization of a lead vegetation). Outcomes and definitions of major or minor complications were based on the most recent Heart Rhythm Society lead management consensus and defined as follows: (1) complete procedural success if all targeted leads were removed from the CS; (2) clinical success if all targeted leads and lead material were removed but with retention of a small portion of the lead that does not negatively impact outcome goals; and (3) failure if neither complete procedural nor clinical success could be achieved.3 Major complications were defined as those that threaten life, require significant surgical intervention, cause persistent or significant disability, or result in death. Complications that
PACE, Vol. 38
R Figure 1. Extracted Attain StarFix leads inside R Evolution tool.
do not meet the major complication criteria are classified as minor complications.3 In all patients transthoracic (TTE) and transesophageal (TEE) echocardiography was performed to visualize or exclude small (2 cm). All lead extractions were performed in a cardiothoracic operating room (OR) with cardiopulmonary bypass pump and in the presence of an experienced cardiothoracic surgeon. After dissection, box removal, and lead exposure a lead locking stylet was introduced R in all StarFix leads. Under fluoroscopic guidance R the 9-Fr EVN (Evolution Cook Intravascular Inc., Leechburg, PA, USA) had to be advanced past the CS ostium and into the target vein (Figs. 1 and 2). The EVN system, which uses no electricity
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R Figure 2. Anterior fluoroscopic views showing procedural steps to remove the StarFix leads. R (A) Before lead extraction, (B) Evolution at the ostium of the CS, (C) in the side branch, (D) final R R before counter-traction of StarFix lead. CS = coronary sinus. position of the Evolution
and is hand-powered, consists of an outer and inner sheath, fitted with a stainless steel tip at its distal end, and is connected to a handle and trigger that rotates it. Both EVN, first-generation and second-generation EVN-RL (right/left) were used. The lead extractions were performed by a single operator who is well versed in all extraction modalities with a large number of cases (>50) per year together with an experienced cardiac surgeon who was present in the OR all the time in case an emergency sternotomy was necessary. All patients were monitored via invasive blood pressure measurements and continuous TEE. Postprocedural examinations included a TTE and a chest x-ray to exclude pericardial effusion, valvular damage, or pneumothorax. After a period of at least one week, reimplantation of a new transvenous system on the contralateral side was performed. Results Between November 2011 and January 2014, R six patients underwent TLE of the Attain StarFix 4195 lead (Medtronic, Inc.). The group consisted of 83% males with a mean age of 64 ± 12 years (Tables I and II). Patients carried their device on
304
average 46.5 ± 8.2 month (range, 36–60 months) before removal. All leads were extracted due R leads to infection. In each of the six StarFix a lead locking device was introduced. In four R the Liberator from Cook (LR-OFA01 Liberator Locking Stylet, Cook Medical, Bloomington, IN, USA), whereas in the remaining two the LLDR R R EZ from Spectranetics was used (LLD Lead Locking Device, Spectranetics, Colorado Springs, CO, USA). In none of the leads could the fixation lobes be retracted. Mean total procedure time was 73.3 minutes (range 60–120 min). All six leads were removed totally. The firstR generation Evolution tool was used in the first R two cases and changed to the new Evolution RL , for the following four cases. In our first patient, a discrete pericardial effusion was seen immediately after the procedure. This effusion disappeared within three days and no pericardiocentesis had to be performed. This patient had bypass surgery years before the extraction. In our opinion this circumstance might explain why the pericardial effusion caused no serious consequences. Postextraction examination of the lead showed tissue growth into the fixation lobes.
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Our second patient experienced pericardial tamponade immediately after successful extraction, requiring immediate surgical intervention (sternotomy). After establishment of an on-pump cardiopulmonary bypass a 5-mm-long sharp cut in the lateral vein of the CS could be identified. The leak was surgically fixed and the patient survived without any sequelae. R In the following four patients all StarFix leads could be extracted with any complications. No patient died within the first 30 days after lead explantation. Discussion Compared to passive fixation CS leads, active fixation leads with anchor lobes near the tip decrease the risk for lead dislodgement and are thus an attractive alternative for the operator. During implant, withdrawal of the push tubing relaxes the lobes to allow repositioning or removal of the lead. However, relaxation of the lobes can be impossible in chronically implanted leads due to significant fibrotic tissue in-growth between the lobes. Extraction of these leads can thus be extremely challenging or impossible, even a few weeks after implantation.4 Various R techniques for removal of the Attain StarFix lead are described, ranging from sole direct traction to the use of locking stylets, to mechanical, cutting, or laser extractions sheaths. Direct traction alone R seems to be sufficient for complete Attain StarFix lead extraction only when the lead has been implanted
Background: Active fixation coronary sinus (CS) leads are widely used in cardiac resynchronization therapy (CRT). Due to their low dislodgement rates they are an attractive option for implanters. However, extraction of active fixation leads is a complex procedure that bears potential fatal risks for patients. R (Medtronic Inc., Minneapolis, MN, USA) Methods: We analyzed all patients undergoing StarFix extraction because of severe infection at our institution. Indication for extraction was severe device infection. Procedural outcomes as well as patient characteristics are reported. For removal of the leads R (Cook Intravascular Inc., Leechburg, PA, USA) mechanical rotation extraction sheath a 9-Fr Evolution was used. R leads. One patient Results: Between 2011 and 2014, six patients underwent extraction of StarFix was female, whereas the others were males (mean age 64 ± 12 years). Implant duration was 46.5 ± 8.2 R . In one patient months before removal. All leads could be successfully extracted totally with the Evolution (16.6%) pericardial tamponade occurred immediately requiring surgical intervention. After establishment of cardiopulmonary bypass a 5-mm sharp cut in the lateral vein of the CS could be identified. It was fixed and the patient survived. On all leads, significant tissue growth between the fixation lobes could be observed. R leads implanted years ago can be extracted with Conclusion: As illustrated by our cases, Attain StarFix the help of a mechanical extraction sheath. However, this procedure bears potential risks and should only R be performed with a cardiac surgery standby. If clinicians evaluate the implantation of Attain StarFix leads in patients who are young or at high risk for device infection, they should be aware of these findings. (PACE 2015; 38:302–305) active fixation leads, lead extraction, device infection, resynchronization therapy
Background The success of cardiac resynchronization therapy (CRT) depends predominantly on the location and therefore the initial placement and stability of the coronary sinus (CS) lead. Although CS lead placement has a very high success rate in experienced hands, the risk of lead dislodgement is about 5–10%.1,2 Device manufacturers have developed different shapes of passive leads to keep them in a stable position within the side branch. To minimize the rate of dislodgement and to avoid phrenic nerve stimulation Medtronic released the first active fixation CS lead in August 2008, the Conflicts of interest: None. No sources of funding. Address for reprints: Alexander Kypta, M.D., Department of Internal Medicine I – Cardiology, Linz General Hospital, Johannes Kepler University School of Medicine, Krankenhausstr. 9, 4021 Linz, Austria. Fax: +4373278066205; e-mail: [email protected] Received March 28, 2014; revised September 30, 2014; accepted October 20, 2014. doi: 10.1111/pace.12552
R Attain StarFix 4195 (Medtronic Inc., Minneapolis, MN, USA). It is a 5-Fr unipolar, steroid-eluting lead with an active fixation mechanism consisting of three polyurethane lobes that are deployed by advancing the push tubing around the lead. When deployed, the lobes range from 5 to 24 French in diameter. To date, published data on extraction of these active fixated CS leads are limited to case reports or small series. Our goal was to describe our approach to this kind of extraction in this important patient group.
Methods The General Hospital in Linz is a tertiary referral clinic for pacemaker and defibrillator lead extraction. All extractions as well as patients demographics, comorbidities, device and lead type, reason for extraction, and procedural success were entered into a computer-based recording system. Between November 2011 and January 2014, outcome of six patients undergoing transvenous lead extraction (TLE) of active fixation CS leads were reviewed. Indications for lead extraction were categorized as systemic infection
©2014 Wiley Periodicals, Inc. 302
March 2015
PACE, Vol. 38
ACTIVE FIXATION LEAD EXTRACTION
Table I. Clinical Charcteristics, Extraction Procedure Variables, and Outcomes Duration of Implant Age Sex (Month) 80 47 53 72 64 50
M F M M M M
36.6 43.4 90.7 45.3 47.6 48.1
Indication for Extraction Systemic infection Pocket infection Lead infection Lead infection Lead infection Pocket infection
Procedure EVN in Time Side EVNExtraction Lobes (Min.) Branch Generation Success Retracted 80 60 60 60 120 60
Yes Yes Yes Yes Yes Yes
First First Second Second Second Second
Complete Complete Complete Complete Complete Complete
No No No No No No
Complication Pericardial effusion Tamponade None None None None
R EVN = Evolution .
Table II. Patients’ Comorbidities Pat. 1 Pat. 2 Pat. 3 Pat. 4 Pat. 5 Pat. 6 Age CAD Dilat. CMP A. Fib. Diabetes HTN COPD Renal Dis. EF%
80 + + + + + − − 40
47 − + − − − + − 50
53 − + − − − − − 20
72 − + − + + − + 20
64 + − − − + − − 30
50 − + − − − − − 25
CAD = coronary artery disease; Dilat. CMP = dilatative cardiomyopathy; A. Fib. = atrial fibrillation; COPD = chronic obstructive pulmonary disease; Renal Dis. = renal disease; EF = ejaction fraction.
(elevated inflammatory lab parameters, positive blood cultures), pocket infection with local signs of inflammation (calor, rubor, tumor, dolor), or lead infection (elevated inflammatory lab parameters, visualization of a lead vegetation). Outcomes and definitions of major or minor complications were based on the most recent Heart Rhythm Society lead management consensus and defined as follows: (1) complete procedural success if all targeted leads were removed from the CS; (2) clinical success if all targeted leads and lead material were removed but with retention of a small portion of the lead that does not negatively impact outcome goals; and (3) failure if neither complete procedural nor clinical success could be achieved.3 Major complications were defined as those that threaten life, require significant surgical intervention, cause persistent or significant disability, or result in death. Complications that
PACE, Vol. 38
R Figure 1. Extracted Attain StarFix leads inside R Evolution tool.
do not meet the major complication criteria are classified as minor complications.3 In all patients transthoracic (TTE) and transesophageal (TEE) echocardiography was performed to visualize or exclude small (2 cm). All lead extractions were performed in a cardiothoracic operating room (OR) with cardiopulmonary bypass pump and in the presence of an experienced cardiothoracic surgeon. After dissection, box removal, and lead exposure a lead locking stylet was introduced R in all StarFix leads. Under fluoroscopic guidance R the 9-Fr EVN (Evolution Cook Intravascular Inc., Leechburg, PA, USA) had to be advanced past the CS ostium and into the target vein (Figs. 1 and 2). The EVN system, which uses no electricity
March 2015
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KYPTA, ET AL.
R Figure 2. Anterior fluoroscopic views showing procedural steps to remove the StarFix leads. R (A) Before lead extraction, (B) Evolution at the ostium of the CS, (C) in the side branch, (D) final R R before counter-traction of StarFix lead. CS = coronary sinus. position of the Evolution
and is hand-powered, consists of an outer and inner sheath, fitted with a stainless steel tip at its distal end, and is connected to a handle and trigger that rotates it. Both EVN, first-generation and second-generation EVN-RL (right/left) were used. The lead extractions were performed by a single operator who is well versed in all extraction modalities with a large number of cases (>50) per year together with an experienced cardiac surgeon who was present in the OR all the time in case an emergency sternotomy was necessary. All patients were monitored via invasive blood pressure measurements and continuous TEE. Postprocedural examinations included a TTE and a chest x-ray to exclude pericardial effusion, valvular damage, or pneumothorax. After a period of at least one week, reimplantation of a new transvenous system on the contralateral side was performed. Results Between November 2011 and January 2014, R six patients underwent TLE of the Attain StarFix 4195 lead (Medtronic, Inc.). The group consisted of 83% males with a mean age of 64 ± 12 years (Tables I and II). Patients carried their device on
304
average 46.5 ± 8.2 month (range, 36–60 months) before removal. All leads were extracted due R leads to infection. In each of the six StarFix a lead locking device was introduced. In four R the Liberator from Cook (LR-OFA01 Liberator Locking Stylet, Cook Medical, Bloomington, IN, USA), whereas in the remaining two the LLDR R R EZ from Spectranetics was used (LLD Lead Locking Device, Spectranetics, Colorado Springs, CO, USA). In none of the leads could the fixation lobes be retracted. Mean total procedure time was 73.3 minutes (range 60–120 min). All six leads were removed totally. The firstR generation Evolution tool was used in the first R two cases and changed to the new Evolution RL , for the following four cases. In our first patient, a discrete pericardial effusion was seen immediately after the procedure. This effusion disappeared within three days and no pericardiocentesis had to be performed. This patient had bypass surgery years before the extraction. In our opinion this circumstance might explain why the pericardial effusion caused no serious consequences. Postextraction examination of the lead showed tissue growth into the fixation lobes.
March 2015
PACE, Vol. 38
ACTIVE FIXATION LEAD EXTRACTION
Our second patient experienced pericardial tamponade immediately after successful extraction, requiring immediate surgical intervention (sternotomy). After establishment of an on-pump cardiopulmonary bypass a 5-mm-long sharp cut in the lateral vein of the CS could be identified. The leak was surgically fixed and the patient survived without any sequelae. R In the following four patients all StarFix leads could be extracted with any complications. No patient died within the first 30 days after lead explantation. Discussion Compared to passive fixation CS leads, active fixation leads with anchor lobes near the tip decrease the risk for lead dislodgement and are thus an attractive alternative for the operator. During implant, withdrawal of the push tubing relaxes the lobes to allow repositioning or removal of the lead. However, relaxation of the lobes can be impossible in chronically implanted leads due to significant fibrotic tissue in-growth between the lobes. Extraction of these leads can thus be extremely challenging or impossible, even a few weeks after implantation.4 Various R techniques for removal of the Attain StarFix lead are described, ranging from sole direct traction to the use of locking stylets, to mechanical, cutting, or laser extractions sheaths. Direct traction alone R seems to be sufficient for complete Attain StarFix lead extraction only when the lead has been implanted
