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Compliant endovascular balloon reduces the lethality of superior vena cava tears during transvenous lead extractions
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Compliant endovascular balloon reduces the lethality of superior vena cava tears during transvenous lead extractions Ryan Azarrafiy, BA,* Darren C. Tsang, BS,* Thomas A. Boyle, BS,* Bruce L. Wilkoff, MD, FHRS,† Roger G. Carrillo, MD, MBA, FHRS* From the *Department of Surgery, Division of Cardiothoracic Surgery, University of Miami Miller School of Medicine, Miami, Florida, and †Department of Cardiovascular Medicine, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Cleveland, Ohio. BACKGROUND Superior vena cava (SVC) lacerations have been identified as the most lethal complication encountered during cardiac implantable electronic device lead extraction. The case fatality rate of these events approximates 50% due to rapid exsanguination. A novel, compliant balloon specifically designed for use in the SVC may provide hemostasis in the event of endovascular perforation. By temporarily occluding the compromised vessel, the endovascular balloon should delay hemodynamic collapse, provide a more controlled surgical field for repair, and thereby reduce the mortality of SVC tears complicating transvenous lead extraction.
contacted for further case details. Confirmed SVC tears were analyzed for patient demographics, repair strategies, and index hospitalization mortality.
OBJECTIVE To assess the early impact of the compliant endovascular balloon on the management of SVC tears and survival outcomes.
CONCLUSION During the study period, we observed a reduction in mortality in patients who suffered SVC tears while undergoing lead extraction when treatment included an endovascular balloon.
METHODS We searched a publicly available, United States Food and Drug Administration–maintained database for adverse events from 1 manufacturer of lead extraction tools. Reports from July 1, 2016, to December 31, 2016 were reviewed by 2 physicians to identify instances of SVC tears. Extracting physicians were
KEYWORDS Lead extraction; Cardiac device; Repair; Superior vena cava; Laceration; Tear; Endovascular; Balloon
Introduction Complications in lead extraction are an infrequent occurrence, yet their onset is sudden and often lethal. Every year, hundreds of thousands of cardiac implantable electronic devices are implanted in the United States alone, successfully treating cardiac arrhythmias.1 Yet with increasing rates of implantation, the number of devices requiring removal due to infection or malfunction has also increased.2 Over the past decade, lead extraction has proven to be a safe and effective Bruce L. Wilkoff has served on the physician advisory board for Spectranetics, Medtronic, and St. Jude Medical; and has received speaking fees from Convatec. Roger G. Carrillo has served as a consultant to Spectranetics and Sensormatic; has received a research grant from St. Jude Medical; and has served on the Speakers Bureau for Medtronic, St. Jude Medical, and the Sorin Group. Address reprint requests and correspondence: Dr Roger G. Carrillo, Chief of Surgical Electrophysiology, University of Miami Hospital, 1295 NW 14th Street, Suite H, 2nd Floor, Miami, FL 33125. E-mail address: [email protected].
1547-5271/$-see front matter © 2017 Heart Rhythm Society. All rights reserved.
RESULTS Of the complications reported, 35 cases of surgically confirmed SVC tears were identified. One hundred percent of patients (9/9) were discharged alive when the endovascular balloon was properly utilized, compared to 50% of patients (13/26) when the device was not used (P 5 .0131). Differences between all other variables analyzed were statistically insignificant.
(Heart Rhythm 2017;-:1–5) All rights reserved.
©
2017 Heart Rhythm Society.
procedure with a major complication rate lower than 2%.3 Unfortunately, the lethality of these complications remains high, as patients undergoing lead extraction are at risk for endovascular perforation, which can lead to rapid hemodynamic collapse. Although a tear can occur anywhere along the path of extraction tools, the superior vena cava (SVC) has been identified as the most concerning site of vascular laceration, as it has been associated with a greater than 50% mortality rate.4 For as long as lead extractions have been performed, SVC tears have been a feared complication for operators. Patient outcomes are dependent on the rapid performance of a thoracotomy and initiation of cardiopulmonary bypass. In the lead extraction population, resuscitation is made even more difficult by the prevalence of comorbidities such as low ejection fraction and sepsis. Historically, the majority of these rescue attempts have been unsuccessful.4 The introduction of a new endovascular balloon (Bridge; Spectranetics, Colorado Springs, CO) has shown early http://dx.doi.org/10.1016/j.hrthm.2017.05.005
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promise in managing SVC tears during lead extractions. The endovascular balloon is a novel device designed to provide temporary occlusion of the SVC in the event of an endovascular tear, thereby limiting blood loss and providing the extraction team additional time for a surgical repair in a more controlled field.5 In the summer of 2016, the endovascular balloon successfully rescued 4 consecutive patients with SVC tears during lead extraction.6 Since then, usage of the endovascular balloon during lead extractions has increased, necessitating further assessment of its impact. This manuscript presents the first data assessing the efficacy of the endovascular balloon, comparing the mortality of SVC tears that were managed with balloon occlusion with cases during the same time period in which the balloon was not utilized.
Methods Description of balloon and instructions for usage The endovascular balloon received United States Food and Drug Administration (FDA) approval in February 2016. The device is a compliant, low-pressure plastic balloon designed to provide hemostasis in the SVC in the event of an endovascular tear (Figure 1). It is 80 mm in length and 20 mm in diameter and has a maximum inflation volume of 60 cc.5 Three steps are taken prior to the initiation of lead extraction. A 0.035-inch stiff guidewire is advanced from the femoral vein optimally to the right internal jugular vein. Second, a 12F introducer sheath is advanced over the stiff guidewire and secured at the insertion site to enable rapid deployment of the endovascular balloon in the event of a tear. Finally, the team should also prepare a sterile 60 cc Luer Lock syringe with a stopcock and a mixture of 48 cc saline and 12 cc contrast media. In the event of sudden patient hypotension, which may be indicative of an SVC tear, the balloon should be quickly advanced through the introducer sheath and over the stiff guidewire, positioned at the SVC, connected to the Luer Lock syringe, and fully inflated.
Data collection In this study, all reported complications from a single lead extraction tool manufacturer from July 1, 2016, to December 31, 2016 were identified using the Manufacturer and User Facility Device Experience (MAUDE) database, an FDAregulated registry of adverse events related to medical devices. The FDA requires device manufacturers, including the sole manufacturer of laser lead extraction tools and the endovascular balloon, to publicly report adverse events within this system. Two physicians independently reviewed the MAUDE database to classify events as SVC tears or non-SVC tears and record survival outcomes. Following these classifications, a standard form was generated to collect demographic data relevant to lead extraction. If this information was unavailable on MAUDE, we requested additional information from the manufacturer and directly contacted extracting physicians to gather the most accurate case data. Cases were subsequently stratified into 2 cohorts: tears in which an endovascular balloon was used according to manufacturer guidelines and tears in which an endovascular balloon was either not used or improperly used.
Inclusion and exclusion criteria For a case to be classified as an SVC event, tears must be surgically confirmed by sternotomy or autopsy. We defined the SVC as the vessel between the innominate vein and the right atrium. All tears of the SVC, including those at the SVC/right atrial and innominate/SVC junctions were also classified as SVC events. All unconfirmed SVC tears, even those suspected, were excluded from this study. If the lacerations involved only the right atrium, right ventricle, innominate vein, or subclavian vein, they were not considered SVC events. Another criterion for inclusion was an attempt to surgically repair either on or off cardiopulmonary bypass. Therefore, patients who underwent median sternotomy without an attempt for repair were excluded. This included a patient with an advance directive to avoid prolonged artificial life support.
Definitions Patients were assigned to the “balloon use” cohort under 2 conditions: if a stiff guidewire was pre-positioned from the right femoral vein to either the right internal jugular or right subclavian vein prior to extraction, and, subsequently, if this wire remained within the vein during balloon deployment. Patients were assigned to the “no use/improper use” cohort if either the balloon was not used entirely or a stiff guidewire was not in the vein during balloon deployment.
Statistical analysis
Figure 1 Fluoroscopic image of inflated endovascular balloon in the superior vena cava.
All cases that met study criteria were analyzed for age, sex, implanted device type, indication for extraction, extraction tools, dwell time of the oldest lead, balloon deployment, and survival at discharge. Statistical analyses were performed using JMP Pro 13 (SAS Institute, Cary, NC). Continuous variables were analyzed using a t test and categorical variables
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The Endovascular Balloon in Lead Extraction
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Azarrafiy et al
Figure 2 Flow chart of study inclusion from July to December 2016. SVC 5 superior vena cava.
were analyzed using a Fisher exact test. All tests were 2-sided, and a P value of .05 was considered statistically significant.
Results Within the study period, 35 instances of confirmed SVC tears were identified (Figure 2), and 33 non-SVC events were excluded from the analysis. Of the 35 confirmed SVC tears, the endovascular balloon was properly deployed after a tear was suspected and before performing open repair in 9 cases. The remaining 26 cases were managed with open surgery but without endovascular occlusion. In all 9 cases (100%) that included proper balloon use, the patient survived the index hospitalization. With no balloon usage or improper balloon usage, 13 (50.0%) survived to discharge (P 5 .0131). Among all patients who experienced an SVC laceration, 19 (54.3) were female, the mean age was 60.2 (6 14.5) years, and the average lead dwell time was 9.62 (6 3.9) years. Among the patients whose treatment included the endovascular balloon, 7 (77.8%) were female, the mean age was 58.3 (6 13.5) years, and the average lead dwell time was 10.6 (6 2.6) years (Table 1). Four of the patients were treated without need for cardiopulmonary bypass, and there were no signs of neurologic deficits prior to discharge.
Notable cases One unfortunate case within the study time frame involved improper balloon deployment, resulting in patient death. Table 1
3 When the patient became hypotensive, the balloon was advanced over the stiff guidewire. However, prior to balloon inflation, the guidewire was inadvertently removed from the vein, thereby compromising the stability of the balloon and leading to patient exsanguination. This case was assigned to the “no use/improper use” cohort. In another case involving a confirmed SVC tear, the lead extraction team was unable to place an introducer sheath into the femoral vein during the chaotic moment of a patient’s hemodynamic collapse. The use of the endovascular balloon was ultimately abandoned and surgical repair failed to rescue the patient. This case was assigned to the “no use/improper use” cohort. A third case involved proper endovascular balloon deployment following a sudden drop in patient blood pressure. However, upon emergent sternotomy, no endovascular tear was discovered, and the patient died from what was later revealed to be pulmonary embolism. This case was categorized as a non-SVC event. In an excluded case within the study time frame, the endovascular balloon was properly deployed following sudden patient hypotension. The cardiac surgeon immediately performed a sternotomy but elected not to initiate a repair upon assessing the severity of the patient’s injury and recognizing that further intervention would go against the patient’s advance directive. The patient died in this case.
Discussion Early evidence has suggested that the endovascular balloon can assist lead extractors in the event of catastrophic complications. However, the rare occurrence of these events presents a challenge in terms of monitoring the efficacy of the intervention. In this study, comparing outcomes in endovascular balloon cases to control cases from the same time period suggested that the balloon may reduce mortality. In addition to this finding, through this study we have gained knowledge on many advantages of the endovascular balloon, valuable lessons for better outcomes, limitations in its use, and future directions in research.
Patient demographics and outcomes
Characteristic
All SVC lacerations (n 5 35)
Balloon cohort (n 5 9)
Age, years Gender, female Device type
60.2 (6 14.5) 19 (54.3) 23 (65.7) ICD 11 (31.4) PPM 1 (2.9) CRTD 11 (33.3) infectious 22 (66.7) noninfectious 2 unavailable 34 (97.1) laser sheaths 1 (2.9) mechanical sheath 9.62 (6 3.9) 22 (62.9)
58.3 (6 13.5) 7 (77.8) 5 (55.6) ICD 4 (44.4) PPM 0 (0) CRTD 3 (33.3) infectious 6 (66.7) noninfectious
Indication for extraction Extraction tools Lead dwell time, years Discharged alive
9 (100) laser sheaths 10.6 (6 2.6) 9 (100)
No balloon or improper usage cohort (n 5 26) 60.8 (6 14.6) 12 (46.2) 18 (69.2) ICD 7 (26.9) PPM 1 (4.4) CRTD 8 (33.3) infectious 16 (66.7) noninfectious 2 unavailable 25 (96.2) laser sheaths 1 (3.8) mechanical sheath 9.3 (6 4.2) 13 (50.0)
P value .323 .135 .686 .416 1.000 1.000 1.000 .852 .013
Values are mean (6 SD) or n (%). CRTD 5 cardiac resynchronization therapy device; ICD 5 implantable cardioverter-defibrillator; PPM 5 permanent pacemaker; SVC 5 superior vena cava. FLA 5.4.0 DTD HRTHM7152_proof 20 May 2017 9:28 am ce
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It should be noted that the observed mortality in control cases (50%) during the study period aligns with previous reports regarding the severity of SVC tears.4,7 In a single-center study, Brunner and colleagues7 report a mortality rate of 31.2% for SVC tears during lead extractions at the Cleveland Clinic, a high-volume extraction center with significant resources and availability of cardiac surgeons. Hauser and colleagues4 paint a picture of how lethal these complications can be in wider practice: By reviewing the Manufacturer and User Facility Device Experience, the authors found 27 SVC tears during sheath-assisted extraction, resulting in 17 deaths (63.0%). When the patient becomes suddenly hypotensive during lead extraction, cardiopulmonary resuscitation is initiated, and a surgeon enters a chaotic scene with a distressed staff and an exsanguinating patient. Due to the lack of interventions in these situations, certain strategies have been utilized in the past. In isolated cases, a cover endovascular stent has been reported as a viable repair strategy for SVC injuries.8 Although such methods may be useful in facilitating a minimally invasive repair in high-risk surgical candidates, they may not fully address the hemodynamic collapse many patients with SVC tears experience. Thus, providers describe the endovascular balloon’s ability to tamponade the SVC and provide temporary hemodynamic stability as one of its greatest advantages. This improved hemodynamic status offers the surgeon both additional time to initiate a repair and a more controlled perioperative environment. Moreover, a unique trend was noted in which 4 out of 9 patients in whom the endovascular balloon was used had their SVC injuries repaired without the use of cardiopulmonary bypass, a traditionally necessary step in the resuscitation of a severely hypovolemic patient. This may suggest that the device can also offer surgeons more choices in their repair technique. It is also important to note that communication among the lead extraction team is the most critical element for patient safety. Although use of an endovascular balloon may have provided a more stable surgical field during SVC tears, some extractors reported balloon preparation as an opportunity to enhance rescue protocols at their facility. These providers explained that preparation for potential balloon deployment required a change in workflow, which opened a line of communication between lead extractors, surgeons, and medical staff to carefully plan for intraoperative complications. Therefore, by incorporating rescue devices into their daily practice, providers have an opportunity to improve existing protocols and communications within the lead extraction team. In addition, discussing key cases within the study time frame provides valuable lessons on the proper usage of the endovascular balloon. In the case involving inadvertent guidewire removal, the stability of the balloon was compromised, and the patient subsequently exsanguinated. This case underscores the importance of retaining the stiff guidewire during deployment to ensure proper positioning and stability in the SVC during chest compressions and other resuscitation maneuvers. Furthermore, in another case within the study,
the team was unable to place an introducer sheath during hemodynamic collapse. This case emphasizes the importance of securing the introducer sheath into the femoral vein and over the stiff guidewire, especially in patients with difficult venous access or high body mass index. Overall, these 2 cases offer valuable workflow lessons and highlight the need for thorough communication on proper usage within the extraction team. Although this study assessed advantages of the endovascular balloon, early clinical experience also revealed certain limitations in its use. Foremost, the endovascular balloon is designed solely for tamponade of the SVC. In our observations, we identified 35 confirmed SVC tears. However, the study time frame also included 33 non-SVC events that would not have benefited from deployment of an endovascular balloon. Additionally, although the endovascular balloon can offer temporary tamponade of the SVC to limit bleeding, it does not substitute the need for surgical intervention. This fact is demonstrated by the case in which the patient’s advanced directive inhibited surgical repair and led to patient death. These cases illustrate that, while particularly useful for SVC tears, the endovascular balloon is not an all-encompassing solution to complications during lead extraction. Lastly, predicting operative complications and morbidity has proven difficult despite several prior attempts. However, we noticed trends in our patient population that were consistent with other reports on what is considered high risk for perforations in lead extraction.9,10 For instance, the majority (54.3%) of patients experiencing SVC tears in this study were female. Furthermore, the majority of SVC tears occurred in patients with implantable cardioverter-defibrillators (65.7%) and those with older leads (9.62 years). We theorize that these high-risk patients may benefit from prophylactic placement of an endovascular balloon in the inferior vena cava to facilitate rapid deployment. The use of this strategy may also extend to physicians new to lead extraction, low-volume operators, and cases in which the level of difficulty and risk changes during the procedure. It is important to note, however, that the thrombolytic risk of prophylactic balloon placement is unknown and further research is needed to determine the safety of this practice. Overall, these data demonstrate great promise for the novel endovascular balloon to transform a historically lethal complication to a more manageable event. It is interesting to note, however, that out of 35 confirmed SVC events in our study, the endovascular balloon was used in only a minority of cases. This may be attributed to lack of awareness about the device or unfamiliarity with its usage. Yet physician experience has shown that the endovascular balloon has had a positive role in improving the transition to surgical repair as well as enhancing communications between extraction teams. Moreover, as knowledge on the endovascular balloon grows and its usage becomes more widely adopted, future studies can continue to evaluate the efficacy of this novel device. Our early data show that, when used with its
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lessons and limitations in mind, the endovascular balloon has lifesaving potential in the management of SVC tears.
superior vena cava tears while undergoing lead extraction when treatment included an endovascular balloon.
Study limitations
References
Although this manuscript presents the best early data available through 2016, it is not without limitations. First, studies pertaining to the endovascular balloon are limited by the fortunately low rate of catastrophic vascular tears nationally. Therefore, the sample size in this study was small. Secondly, the study relies on a public database that provides limited case information and assumes hospital and industry compliance with federal reporting regulations. For example, certain variables for each case were not consistently reported, such as operative setting, arteriovenous access, transesophageal echocardiogram surveillance, and bypass equipment availability. Thus, these variables could not be included in the study. Third, the total number of adverse events during lead extraction is obtained from a single industry manufacturer maintaining an active registry of these events. Thus, adverse events from other companies manufacturing lead extraction tools were not investigated, limiting the data to the number of adverse events occurring under 1 lead extraction tool manufacturer. Overall, the study would have benefited from increased sample size and a registry that does not rely on self-reporting.
Conclusions During the period from July 2016 through December 2016, we observed a reduction in mortality in patients who suffered
1. Zhan C, Baine WB, Sedrakyan A, Steiner C. Cardiac device implantation in the United States from 1997 through 2004: a population-based analysis. J Gen Intern Med 2008;23(1):13–19. 2. Greenspon AJ, Patel JD, Lau E, Ochoa JA, Frisch DR, Ho RT, Kurtz SM. Trends in permanent pacemaker implantation in the United States from 1993 to 2009: increasing complexity of patients and procedures. J Am Coll Cardiol 2012; 60(16):1540–1545. 3. Wazni O, Wilkoff BL. Considerations for cardiac device lead extraction. Nat Rev Cardiol 2016;13(4):221–229. 4. Hauser RG, Katsiyiannis WT, Gornick CC, Almquist AK, Kallinen LM. Deaths and cardiovascular injuries due to device-assisted implantable cardioverterdefibrillator and pacemaker lead extraction. Europace 2010;12(3):395–401. 5. Clancy JF, Carrillo RG, Sotak R, Ram R, Ryu RK, Kennergren C. Percutaneous occlusion balloon as a bridge to surgery in a swine model of superior vena cava perforation. Heart Rhythm 2016;13(11):2215–2220. 6. Boyle TA, Wilkoff BL, Pace J, Saleem M, Jones S, Carrillo R. Balloon assisted rescue of four consecutive patients with vascular lacerations inflicted during lead extraction. Heart Rhythm 2017;14(5):757–760. 7. Brunner MP, Cronin EM, Wazni O, Baranowski B, Saliba WI, Sabik JF, Lindsay BD, Wilkoff BL, Tarajki KG. Outcomes of patients requiring emergent surgical or endovascular intervention for catastrophic complications during transvenous lead extraction. Heart Rhythm 2014;11(3):419–425. 8. Lou X, Brunner MP, Wilkoff BL, Martin DO, Clair DG, Stoltesz EG. Successful stent implantation for superior vena cava injury during transvenous lead extraction. HeartRhythm Case Rep 2015;1(6):394–396. 9. Wilkoff BL, Love CJ, Byrd CL, Bongiorni MG, Carrillo RG, Crossley GH, Epstein LM, Friedman RA, Kennergren CEH, Mitkowski P, Schaerf RHM, Wazni OM. Transvenous lead extraction: Heart Rhythm Society expert consensus facilities, training, indications and patient management. Heart Rhythm 2009; 6(7):1085–1104. 10. Fu H, Huang X, Zhong L, et al. Outcomes and complications of lead removal: can we establish a risk stratification schema for a collaborative and effective approach? Pacing Clin Electrophysiol 2015;38(12):1439–1447.
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Compliant endovascular balloon reduces the lethality of superior vena cava tears during transvenous lead extractions Ryan Azarrafiy, BA,* Darren C. Tsang, BS,* Thomas A. Boyle, BS,* Bruce L. Wilkoff, MD, FHRS,† Roger G. Carrillo, MD, MBA, FHRS* From the *Department of Surgery, Division of Cardiothoracic Surgery, University of Miami Miller School of Medicine, Miami, Florida, and †Department of Cardiovascular Medicine, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Cleveland, Ohio. BACKGROUND Superior vena cava (SVC) lacerations have been identified as the most lethal complication encountered during cardiac implantable electronic device lead extraction. The case fatality rate of these events approximates 50% due to rapid exsanguination. A novel, compliant balloon specifically designed for use in the SVC may provide hemostasis in the event of endovascular perforation. By temporarily occluding the compromised vessel, the endovascular balloon should delay hemodynamic collapse, provide a more controlled surgical field for repair, and thereby reduce the mortality of SVC tears complicating transvenous lead extraction.
contacted for further case details. Confirmed SVC tears were analyzed for patient demographics, repair strategies, and index hospitalization mortality.
OBJECTIVE To assess the early impact of the compliant endovascular balloon on the management of SVC tears and survival outcomes.
CONCLUSION During the study period, we observed a reduction in mortality in patients who suffered SVC tears while undergoing lead extraction when treatment included an endovascular balloon.
METHODS We searched a publicly available, United States Food and Drug Administration–maintained database for adverse events from 1 manufacturer of lead extraction tools. Reports from July 1, 2016, to December 31, 2016 were reviewed by 2 physicians to identify instances of SVC tears. Extracting physicians were
KEYWORDS Lead extraction; Cardiac device; Repair; Superior vena cava; Laceration; Tear; Endovascular; Balloon
Introduction Complications in lead extraction are an infrequent occurrence, yet their onset is sudden and often lethal. Every year, hundreds of thousands of cardiac implantable electronic devices are implanted in the United States alone, successfully treating cardiac arrhythmias.1 Yet with increasing rates of implantation, the number of devices requiring removal due to infection or malfunction has also increased.2 Over the past decade, lead extraction has proven to be a safe and effective Bruce L. Wilkoff has served on the physician advisory board for Spectranetics, Medtronic, and St. Jude Medical; and has received speaking fees from Convatec. Roger G. Carrillo has served as a consultant to Spectranetics and Sensormatic; has received a research grant from St. Jude Medical; and has served on the Speakers Bureau for Medtronic, St. Jude Medical, and the Sorin Group. Address reprint requests and correspondence: Dr Roger G. Carrillo, Chief of Surgical Electrophysiology, University of Miami Hospital, 1295 NW 14th Street, Suite H, 2nd Floor, Miami, FL 33125. E-mail address: [email protected].
1547-5271/$-see front matter © 2017 Heart Rhythm Society. All rights reserved.
RESULTS Of the complications reported, 35 cases of surgically confirmed SVC tears were identified. One hundred percent of patients (9/9) were discharged alive when the endovascular balloon was properly utilized, compared to 50% of patients (13/26) when the device was not used (P 5 .0131). Differences between all other variables analyzed were statistically insignificant.
(Heart Rhythm 2017;-:1–5) All rights reserved.
©
2017 Heart Rhythm Society.
procedure with a major complication rate lower than 2%.3 Unfortunately, the lethality of these complications remains high, as patients undergoing lead extraction are at risk for endovascular perforation, which can lead to rapid hemodynamic collapse. Although a tear can occur anywhere along the path of extraction tools, the superior vena cava (SVC) has been identified as the most concerning site of vascular laceration, as it has been associated with a greater than 50% mortality rate.4 For as long as lead extractions have been performed, SVC tears have been a feared complication for operators. Patient outcomes are dependent on the rapid performance of a thoracotomy and initiation of cardiopulmonary bypass. In the lead extraction population, resuscitation is made even more difficult by the prevalence of comorbidities such as low ejection fraction and sepsis. Historically, the majority of these rescue attempts have been unsuccessful.4 The introduction of a new endovascular balloon (Bridge; Spectranetics, Colorado Springs, CO) has shown early http://dx.doi.org/10.1016/j.hrthm.2017.05.005
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promise in managing SVC tears during lead extractions. The endovascular balloon is a novel device designed to provide temporary occlusion of the SVC in the event of an endovascular tear, thereby limiting blood loss and providing the extraction team additional time for a surgical repair in a more controlled field.5 In the summer of 2016, the endovascular balloon successfully rescued 4 consecutive patients with SVC tears during lead extraction.6 Since then, usage of the endovascular balloon during lead extractions has increased, necessitating further assessment of its impact. This manuscript presents the first data assessing the efficacy of the endovascular balloon, comparing the mortality of SVC tears that were managed with balloon occlusion with cases during the same time period in which the balloon was not utilized.
Methods Description of balloon and instructions for usage The endovascular balloon received United States Food and Drug Administration (FDA) approval in February 2016. The device is a compliant, low-pressure plastic balloon designed to provide hemostasis in the SVC in the event of an endovascular tear (Figure 1). It is 80 mm in length and 20 mm in diameter and has a maximum inflation volume of 60 cc.5 Three steps are taken prior to the initiation of lead extraction. A 0.035-inch stiff guidewire is advanced from the femoral vein optimally to the right internal jugular vein. Second, a 12F introducer sheath is advanced over the stiff guidewire and secured at the insertion site to enable rapid deployment of the endovascular balloon in the event of a tear. Finally, the team should also prepare a sterile 60 cc Luer Lock syringe with a stopcock and a mixture of 48 cc saline and 12 cc contrast media. In the event of sudden patient hypotension, which may be indicative of an SVC tear, the balloon should be quickly advanced through the introducer sheath and over the stiff guidewire, positioned at the SVC, connected to the Luer Lock syringe, and fully inflated.
Data collection In this study, all reported complications from a single lead extraction tool manufacturer from July 1, 2016, to December 31, 2016 were identified using the Manufacturer and User Facility Device Experience (MAUDE) database, an FDAregulated registry of adverse events related to medical devices. The FDA requires device manufacturers, including the sole manufacturer of laser lead extraction tools and the endovascular balloon, to publicly report adverse events within this system. Two physicians independently reviewed the MAUDE database to classify events as SVC tears or non-SVC tears and record survival outcomes. Following these classifications, a standard form was generated to collect demographic data relevant to lead extraction. If this information was unavailable on MAUDE, we requested additional information from the manufacturer and directly contacted extracting physicians to gather the most accurate case data. Cases were subsequently stratified into 2 cohorts: tears in which an endovascular balloon was used according to manufacturer guidelines and tears in which an endovascular balloon was either not used or improperly used.
Inclusion and exclusion criteria For a case to be classified as an SVC event, tears must be surgically confirmed by sternotomy or autopsy. We defined the SVC as the vessel between the innominate vein and the right atrium. All tears of the SVC, including those at the SVC/right atrial and innominate/SVC junctions were also classified as SVC events. All unconfirmed SVC tears, even those suspected, were excluded from this study. If the lacerations involved only the right atrium, right ventricle, innominate vein, or subclavian vein, they were not considered SVC events. Another criterion for inclusion was an attempt to surgically repair either on or off cardiopulmonary bypass. Therefore, patients who underwent median sternotomy without an attempt for repair were excluded. This included a patient with an advance directive to avoid prolonged artificial life support.
Definitions Patients were assigned to the “balloon use” cohort under 2 conditions: if a stiff guidewire was pre-positioned from the right femoral vein to either the right internal jugular or right subclavian vein prior to extraction, and, subsequently, if this wire remained within the vein during balloon deployment. Patients were assigned to the “no use/improper use” cohort if either the balloon was not used entirely or a stiff guidewire was not in the vein during balloon deployment.
Statistical analysis
Figure 1 Fluoroscopic image of inflated endovascular balloon in the superior vena cava.
All cases that met study criteria were analyzed for age, sex, implanted device type, indication for extraction, extraction tools, dwell time of the oldest lead, balloon deployment, and survival at discharge. Statistical analyses were performed using JMP Pro 13 (SAS Institute, Cary, NC). Continuous variables were analyzed using a t test and categorical variables
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Figure 2 Flow chart of study inclusion from July to December 2016. SVC 5 superior vena cava.
were analyzed using a Fisher exact test. All tests were 2-sided, and a P value of .05 was considered statistically significant.
Results Within the study period, 35 instances of confirmed SVC tears were identified (Figure 2), and 33 non-SVC events were excluded from the analysis. Of the 35 confirmed SVC tears, the endovascular balloon was properly deployed after a tear was suspected and before performing open repair in 9 cases. The remaining 26 cases were managed with open surgery but without endovascular occlusion. In all 9 cases (100%) that included proper balloon use, the patient survived the index hospitalization. With no balloon usage or improper balloon usage, 13 (50.0%) survived to discharge (P 5 .0131). Among all patients who experienced an SVC laceration, 19 (54.3) were female, the mean age was 60.2 (6 14.5) years, and the average lead dwell time was 9.62 (6 3.9) years. Among the patients whose treatment included the endovascular balloon, 7 (77.8%) were female, the mean age was 58.3 (6 13.5) years, and the average lead dwell time was 10.6 (6 2.6) years (Table 1). Four of the patients were treated without need for cardiopulmonary bypass, and there were no signs of neurologic deficits prior to discharge.
Notable cases One unfortunate case within the study time frame involved improper balloon deployment, resulting in patient death. Table 1
3 When the patient became hypotensive, the balloon was advanced over the stiff guidewire. However, prior to balloon inflation, the guidewire was inadvertently removed from the vein, thereby compromising the stability of the balloon and leading to patient exsanguination. This case was assigned to the “no use/improper use” cohort. In another case involving a confirmed SVC tear, the lead extraction team was unable to place an introducer sheath into the femoral vein during the chaotic moment of a patient’s hemodynamic collapse. The use of the endovascular balloon was ultimately abandoned and surgical repair failed to rescue the patient. This case was assigned to the “no use/improper use” cohort. A third case involved proper endovascular balloon deployment following a sudden drop in patient blood pressure. However, upon emergent sternotomy, no endovascular tear was discovered, and the patient died from what was later revealed to be pulmonary embolism. This case was categorized as a non-SVC event. In an excluded case within the study time frame, the endovascular balloon was properly deployed following sudden patient hypotension. The cardiac surgeon immediately performed a sternotomy but elected not to initiate a repair upon assessing the severity of the patient’s injury and recognizing that further intervention would go against the patient’s advance directive. The patient died in this case.
Discussion Early evidence has suggested that the endovascular balloon can assist lead extractors in the event of catastrophic complications. However, the rare occurrence of these events presents a challenge in terms of monitoring the efficacy of the intervention. In this study, comparing outcomes in endovascular balloon cases to control cases from the same time period suggested that the balloon may reduce mortality. In addition to this finding, through this study we have gained knowledge on many advantages of the endovascular balloon, valuable lessons for better outcomes, limitations in its use, and future directions in research.
Patient demographics and outcomes
Characteristic
All SVC lacerations (n 5 35)
Balloon cohort (n 5 9)
Age, years Gender, female Device type
60.2 (6 14.5) 19 (54.3) 23 (65.7) ICD 11 (31.4) PPM 1 (2.9) CRTD 11 (33.3) infectious 22 (66.7) noninfectious 2 unavailable 34 (97.1) laser sheaths 1 (2.9) mechanical sheath 9.62 (6 3.9) 22 (62.9)
58.3 (6 13.5) 7 (77.8) 5 (55.6) ICD 4 (44.4) PPM 0 (0) CRTD 3 (33.3) infectious 6 (66.7) noninfectious
Indication for extraction Extraction tools Lead dwell time, years Discharged alive
9 (100) laser sheaths 10.6 (6 2.6) 9 (100)
No balloon or improper usage cohort (n 5 26) 60.8 (6 14.6) 12 (46.2) 18 (69.2) ICD 7 (26.9) PPM 1 (4.4) CRTD 8 (33.3) infectious 16 (66.7) noninfectious 2 unavailable 25 (96.2) laser sheaths 1 (3.8) mechanical sheath 9.3 (6 4.2) 13 (50.0)
P value .323 .135 .686 .416 1.000 1.000 1.000 .852 .013
Values are mean (6 SD) or n (%). CRTD 5 cardiac resynchronization therapy device; ICD 5 implantable cardioverter-defibrillator; PPM 5 permanent pacemaker; SVC 5 superior vena cava. FLA 5.4.0 DTD HRTHM7152_proof 20 May 2017 9:28 am ce
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It should be noted that the observed mortality in control cases (50%) during the study period aligns with previous reports regarding the severity of SVC tears.4,7 In a single-center study, Brunner and colleagues7 report a mortality rate of 31.2% for SVC tears during lead extractions at the Cleveland Clinic, a high-volume extraction center with significant resources and availability of cardiac surgeons. Hauser and colleagues4 paint a picture of how lethal these complications can be in wider practice: By reviewing the Manufacturer and User Facility Device Experience, the authors found 27 SVC tears during sheath-assisted extraction, resulting in 17 deaths (63.0%). When the patient becomes suddenly hypotensive during lead extraction, cardiopulmonary resuscitation is initiated, and a surgeon enters a chaotic scene with a distressed staff and an exsanguinating patient. Due to the lack of interventions in these situations, certain strategies have been utilized in the past. In isolated cases, a cover endovascular stent has been reported as a viable repair strategy for SVC injuries.8 Although such methods may be useful in facilitating a minimally invasive repair in high-risk surgical candidates, they may not fully address the hemodynamic collapse many patients with SVC tears experience. Thus, providers describe the endovascular balloon’s ability to tamponade the SVC and provide temporary hemodynamic stability as one of its greatest advantages. This improved hemodynamic status offers the surgeon both additional time to initiate a repair and a more controlled perioperative environment. Moreover, a unique trend was noted in which 4 out of 9 patients in whom the endovascular balloon was used had their SVC injuries repaired without the use of cardiopulmonary bypass, a traditionally necessary step in the resuscitation of a severely hypovolemic patient. This may suggest that the device can also offer surgeons more choices in their repair technique. It is also important to note that communication among the lead extraction team is the most critical element for patient safety. Although use of an endovascular balloon may have provided a more stable surgical field during SVC tears, some extractors reported balloon preparation as an opportunity to enhance rescue protocols at their facility. These providers explained that preparation for potential balloon deployment required a change in workflow, which opened a line of communication between lead extractors, surgeons, and medical staff to carefully plan for intraoperative complications. Therefore, by incorporating rescue devices into their daily practice, providers have an opportunity to improve existing protocols and communications within the lead extraction team. In addition, discussing key cases within the study time frame provides valuable lessons on the proper usage of the endovascular balloon. In the case involving inadvertent guidewire removal, the stability of the balloon was compromised, and the patient subsequently exsanguinated. This case underscores the importance of retaining the stiff guidewire during deployment to ensure proper positioning and stability in the SVC during chest compressions and other resuscitation maneuvers. Furthermore, in another case within the study,
the team was unable to place an introducer sheath during hemodynamic collapse. This case emphasizes the importance of securing the introducer sheath into the femoral vein and over the stiff guidewire, especially in patients with difficult venous access or high body mass index. Overall, these 2 cases offer valuable workflow lessons and highlight the need for thorough communication on proper usage within the extraction team. Although this study assessed advantages of the endovascular balloon, early clinical experience also revealed certain limitations in its use. Foremost, the endovascular balloon is designed solely for tamponade of the SVC. In our observations, we identified 35 confirmed SVC tears. However, the study time frame also included 33 non-SVC events that would not have benefited from deployment of an endovascular balloon. Additionally, although the endovascular balloon can offer temporary tamponade of the SVC to limit bleeding, it does not substitute the need for surgical intervention. This fact is demonstrated by the case in which the patient’s advanced directive inhibited surgical repair and led to patient death. These cases illustrate that, while particularly useful for SVC tears, the endovascular balloon is not an all-encompassing solution to complications during lead extraction. Lastly, predicting operative complications and morbidity has proven difficult despite several prior attempts. However, we noticed trends in our patient population that were consistent with other reports on what is considered high risk for perforations in lead extraction.9,10 For instance, the majority (54.3%) of patients experiencing SVC tears in this study were female. Furthermore, the majority of SVC tears occurred in patients with implantable cardioverter-defibrillators (65.7%) and those with older leads (9.62 years). We theorize that these high-risk patients may benefit from prophylactic placement of an endovascular balloon in the inferior vena cava to facilitate rapid deployment. The use of this strategy may also extend to physicians new to lead extraction, low-volume operators, and cases in which the level of difficulty and risk changes during the procedure. It is important to note, however, that the thrombolytic risk of prophylactic balloon placement is unknown and further research is needed to determine the safety of this practice. Overall, these data demonstrate great promise for the novel endovascular balloon to transform a historically lethal complication to a more manageable event. It is interesting to note, however, that out of 35 confirmed SVC events in our study, the endovascular balloon was used in only a minority of cases. This may be attributed to lack of awareness about the device or unfamiliarity with its usage. Yet physician experience has shown that the endovascular balloon has had a positive role in improving the transition to surgical repair as well as enhancing communications between extraction teams. Moreover, as knowledge on the endovascular balloon grows and its usage becomes more widely adopted, future studies can continue to evaluate the efficacy of this novel device. Our early data show that, when used with its
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lessons and limitations in mind, the endovascular balloon has lifesaving potential in the management of SVC tears.
superior vena cava tears while undergoing lead extraction when treatment included an endovascular balloon.
Study limitations
References
Although this manuscript presents the best early data available through 2016, it is not without limitations. First, studies pertaining to the endovascular balloon are limited by the fortunately low rate of catastrophic vascular tears nationally. Therefore, the sample size in this study was small. Secondly, the study relies on a public database that provides limited case information and assumes hospital and industry compliance with federal reporting regulations. For example, certain variables for each case were not consistently reported, such as operative setting, arteriovenous access, transesophageal echocardiogram surveillance, and bypass equipment availability. Thus, these variables could not be included in the study. Third, the total number of adverse events during lead extraction is obtained from a single industry manufacturer maintaining an active registry of these events. Thus, adverse events from other companies manufacturing lead extraction tools were not investigated, limiting the data to the number of adverse events occurring under 1 lead extraction tool manufacturer. Overall, the study would have benefited from increased sample size and a registry that does not rely on self-reporting.
Conclusions During the period from July 2016 through December 2016, we observed a reduction in mortality in patients who suffered
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