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Accepted Manuscript
Long-Term Outcomes of Prophylactic Placement of an Endovascular Balloon in theVena Cava for High-Risk Transvenous Lead Extractions
Darren C. Tsang, BS, Ryan Azarrafiy, BA, Simon Pecha, MD, HermannReichenspurner, MD, PhD, Roger G. Carrillo, MD, MBA, FHRS, Samer Hakmi, MD
PII: S1547-5271(17)30964-5
DOI: 10.1016/j.hrthm.2017.08.003
Reference: HRTHM 7266
To appear in: Heart Rhythm
Received Date: 10 July 2017
Revised Date: 1547-5271 1547-5271
Accepted Date: 1547-5271 1547-5271
Please cite this article as: Tsang DC, Azarrafiy R, Pecha S, Reichenspurner H, Carrillo RG, Hakmi S,Long-Term Outcomes of Prophylactic Placement of an Endovascular Balloon in the Vena Cava for High-Risk Transvenous Lead Extractions, Heart Rhythm (2017), doi: 10.1016/j.hrthm.2017.08.003.
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Title: Long-Term Outcomes of Prophylactic Placement of an Endovascular Balloon in the Vena 1
Cava for High-Risk Transvenous Lead Extractions 2
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Short Title: Long-term Outcomes in Prophylactic Balloon Placement 4
5
Authors: Darren C. Tsang, BS1; Ryan Azarrafiy, BA1; Simon Pecha, MD2; Hermann 6
Reichenspurner, MD, PhD2; Roger G. Carrillo, MD, MBA, FHRS1; Samer Hakmi, MD2 7
8
1 Division of Cardiothoracic Surgery, University of Miami Miller School of Medicine, Miami, 9
Florida 10
2 Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg, Germany 11
12
Author information: 13
Darren C. Tsang, BS 14
University of Miami Miller School of Medicine, Department of Surgery, Division of 15
Cardiothoracic Surgery, Miami, FL, USA 16
18
Ryan Azarrafiy, BA 19
University of Miami Miller School of Medicine, Department of Surgery, Division of 20
Cardiothoracic Surgery, Miami, FL, USA 21
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Simon Pecha, MD 24
University Heart Center Hamburg, Department of Cardiovascular Surgery, Hamburg, Germany 25
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Hermann Reichenspurner, MD, PhD 28
University Heart Center Hamburg, Department of Cardiovascular Surgery, Hamburg, Germany 29
31
Roger G. Carrillo, MD, MBA, FHRS 32
University of Miami Miller School of Medicine, Department of Surgery, Division of 33
Cardiothoracic Surgery, Miami, FL, USA 34
36
Samer Hakmi, MD 37
University Heart Center Hamburg, Department of Cardiovascular Surgery, Hamburg, Germany 38
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Corresponding Author: 41
Roger G. Carrillo 42
Chief of Surgical Electrophysiology 43
University of Miami Hospital 44
1295 NW 14th Street, Suite H, 2nd Floor 45
Miami, FL 33125 46
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(305)-689-2780 47
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Word Count: 4197 50
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Keywords: 52
Transvenous Lead Extraction; Prophylactic Placement; Bridge; Endovascular Balloon; Long-53
term Outcomes 54
55
Funding: 56
This research did not receive any specific grant from funding agencies in the public, commercial, 57
or not-for-profit sectors. 58
59
Disclosures: 60
Darren C. Tsang, Ryan Azarrafiy, Simon Pecha, and Hermann Reichenspurner have no 61
disclosures. Roger G. Carrillo has served as a consultant to Spectranetics and Sensormatic; has 62
received a research grant from St. Jude Medical; and has served on the Speakers Bureau for 63
Medtronic, St. Jude Medical, and the Sorin Group. Samer Hakmi has served as a 64
consultant/training proctor for Spectranetics; and has received speaking fees from Spectranetics, 65
St. Jude Medical and Zoll Medical Corporation. 66
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Abstract: 70
Background: Many clinicians utilize the strategy of prophylactically placing an endovascular 71
balloon prior to transvenous lead extraction, yet there is no data regarding this practice. 72
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Objective: This study assesses long-term outcomes of prophylactic placement of an endovascular 74
balloon in the venae cavae of patients during transvenous lead extraction. 75
76
Methods: From April 2016 to March 2017, data was prospectively collected at two international 77
cardiovascular centers on patients who had the balloon prophylactically placed in the venae 78
cavae. Patients were monitored for a minimum of 3 months to capture any associated adverse 79
events. 80
81
Results: Twenty-one patients had the balloon prophylactically placed in the venae cavae during 82
lead extraction. The majority were male (76%), mean age was 57.6 ± 18.7 years, and mean BMI 83
was 26.1 ± 4.4. Mean lead dwell time was 11.2 ± 8.3 years, with an average of 2.2 ± 1.1 leads 84
per case, and most indications for extraction were non-infectious (62%). Two minor 85
complications (10%, pocket hematomas) and 1 major complication (5%, cardiac tamponade) 86
occurred during the procedure. All cases (100%) were procedural successes, and all patients 87
(100%) were discharged alive. On follow-up (6.8 ± 3.7 months), all patients were alive and 88
reported no adverse events related to prophylactic balloon placement, such as pulmonary emboli 89
or deep venous thrombi. 90
91
Conclusion: During the study period, we observed no acute or long-term adverse outcomes 92
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associated with prophylactic placement of an endovascular balloon in the venae cavae of patients 93
undergoing transvenous lead extraction. 94
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Introduction 116
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A superior vena cava (SVC) tear is the most lethal and challenging complication that can 118
occur during transvenous lead extraction. As infected or malfunctioning cardiac device leads are 119
extracted from a patient, sudden hemodynamic collapse would necessitate an urgent sternotomy 120
to surgically repair what may likely be an SVC laceration.1 While this complication is quite rare, 121
occurring in only 0.5% of cases,2 it has disastrous effects on both patient outcomes and fears 122
regarding lead extraction. Moreover, as both the implantation and extraction of cardiac 123
implantable electronic devices have increased over the past several years, the total number of 124
patients experiencing this catastrophic complication has increased as well.3 Therefore, the 125
availability of rescue tools and the identification of high-risk patients are paramount to patient 126
safety and provider readiness for this rare, yet critical, complication of transvenous lead 127
extraction. 128
Early clinical data have shown that a novel, endovascular balloon (BridgeTM, 129
Spectranetics Corporation, Colorado Springs, CO) may reduce mortality associated with SVC 130
tears during transvenous lead extractions.4 In the event of sudden hemodynamic collapse during 131
lead extraction, this balloon may be quickly positioned in the SVC and deployed to provide 132
hemostasis and hemodynamic stability, facilitating a more controlled surgical repair. As early 133
data regarding the balloon’s utility have been positive, new questions have also emerged 134
regarding when the balloon should be available and utilized. In a 2015 Mayo Clinic study, Fu 135
and colleagues developed a risk stratification schema to identify which patients are at highest 136
risk for complications, including, but not limited to, patients with low body mass index (BMI) 137
and older leads.5 Consequently, with the development of the endovascular balloon to treat SVC 138
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tears, some providers describe prophylactically placing the device in the superior or inferior vena 139
cava (IVC) of these high-risk patients.4,6 This practice has raised concerns regarding thrombosis 140
and potential adverse effects to the patient, such as pulmonary embolism. While there is 141
preliminary information on the acute usage of the balloon, there is a paucity of data on the long-142
term effects of prophylactic balloon placement. 143
Thus, this study assesses long-term outcomes of prophylactic placement of an 144
endovascular balloon in the venae cavae of patients during transvenous lead extraction. 145
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Methods 147
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Description of balloon and the prophylactic placement strategy 149
The endovascular balloon received United States Food and Drug Administration (FDA) 150
approval in February 2016 and Conformité Européene (CE) mark approval in May 2016. The 151
device is a compliant, low-pressure polyurethane balloon designed to provide temporary 152
hemostasis in the SVC in the event of an endovascular tear. It is 80 mm in length, 20 mm in 153
diameter, and has a recommended inflation volume of 60 cc. 154
In patients deemed high-risk, providers describe several steps taken prior to the initiation 155
of lead extraction. First, a 12F introducer sheath is placed in the right femoral vein and secured at 156
the insertion site with sutures. Second, a 0.035-inch stiff guidewire is advanced through the 157
introducer sheath optimally to the right internal jugular vein or right subclavian vein (Figure 1). 158
Third, the endovascular balloon is prophylactically advanced through the introducer sheath, over 159
the stiff guidewire, and positioned in the superior vena cava (Figure 2). In the fourth step 160
(‘inflation’), the balloon is slowly expanded in the SVC with an 80/20 saline/contrast mixture 161
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under fluoroscopy to determine the volume required to fully occlude the vessel (Figure 3). The 162
SVC occlusion can also be confirmed by injecting a contrast medium through a 5F pigtail 163
catheter introduced via the femoral vein (Figure 4). In the fifth and last step prior to lead 164
extraction (‘placement’), the balloon is deflated and either retained in the SVC or withdrawn into 165
the IVC. In the event of sudden patient hypotension, which may indicate a tear in the SVC, the 166
balloon can be quickly repositioned at the SVC and deployed in a matter of seconds. 167
168
Data collection 169
At two tertiary cardiovascular referral centers in the United States and Germany, clinical 170
data was prospectively gathered for all patients who had the endovascular balloon 171
prophylactically placed in the SVC or IVC prior to transvenous lead extraction. Study enrollment 172
began in April 2016 and concluded in March 2017. The study was conducted with institutional 173
review board (IRB) approval at both institutions, and study participants provided their informed 174
consent. All cases were performed in either an operating room or a hybrid suite under general 175
anesthesia with the aid of fluoroscopy, transesophageal echocardiography, and intra-arterial 176
blood pressure monitoring. Patient demographics and procedural data were collected during the 177
index hospitalization, including but not limited to: age, sex, implanted device type, indication for 178
extraction, extraction tools, dwell time of the oldest lead, location of prophylactic placement, 179
laser time use, post-procedural balloon integrity, and survival at discharge. We collected 180
procedural success rate in addition to major and minor complications as defined by the 2009 181
Heart Rhythm Society (HRS) expert consensus7. 182
Subsequently, patients were monitored for a minimum of three months to capture any 183
long-term effects of this strategy. These include all-cause mortality, hospitalizations, and adverse 184
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events related to prophylactic balloon placement such as pain or presence of an arteriovenous 185
fistula at the site of balloon insertion, deep vein thrombosis, or more distal complications such as 186
pulmonary emboli. 187
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Patient selection 189
Our two high-volume lead extraction centers perform a combined 220 lead extraction 190
cases per year and had similar criteria for identifying high-risk patients. Patients were classified 191
as high-risk and considered for prophylactic balloon placement if they had any of the following 192
characteristics: female sex, low BMI, leads older than 6 years, dual-coil implantable cardiac 193
defibrillator (ICD) leads, or currently prescribed steroid therapy. In addition to the above criteria, 194
the institutions also selected patients for prophylactic balloon placement when computed 195
tomography (CT) or venography revealed aggressive calcified adhesions, extracardiac leads, or 196
venous occlusions. 197
198
Inclusion and exclusion criteria 199
For a case to be included in this study, the following steps must have been conducted: the 200
endovascular balloon should have been introduced in the femoral vein, inflated in the SVC for 201
approximately 30 seconds, deflated, and then positioned in either the SVC or IVC prior to 202
transvenous lead extraction. The balloon must also have been retained within either of these 203
vessels throughout the duration of the procedure. 204
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Statistical analysis 206
Summary statistics for both acute and long-term follow-up data were generated using 207
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JMP Pro 13 (SAS Institute, Cary, NC). 208
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Results 210
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During the study period, 21 patients had the endovascular balloon prophylactically placed 212
prior to transvenous lead extraction. Among all patients, the majority were male (76%), mean 213
age was 57.6 ± 18.7 years, and mean BMI was 26.1 ± 4.4 (Table 1. Demographics). Extracted 214
devices consisted of 8 pacemakers (38%), 7 ICDs (33%), and 6 cardiac resynchronization 215
therapy defibrillators (29%), with an average of 2.2 ± 1.1 leads per case and a mean lead dwell 216
time of 11.2 ± 8.3 years. Eight cases (38%) necessitated the extraction of previously abandoned 217
leads and 2 cases (10%) had leads that appeared extracardiac in gated CT imaging. Laser sheaths 218
were used in all cases, 9 of which (43%) required the use of both mechanical and laser extraction 219
tools (Table 2. Device and Procedural Data). The balloon was prophylactically placed in the 220
IVC in 11 cases (52%) and retained in the SVC in 10 cases (48%) for the duration of lead 221
extraction. Post-procedural examination in all 21 cases revealed that the prophylactically placed 222
balloon was functional and remained undamaged. Two minor complications (10%, pocket 223
hematomas) and 1 major complication (5%, cardiac tamponade requiring surgical intervention) 224
occurred during the procedure. A procedural success rate of 100% was achieved and all patients 225
were discharged alive. 226
At the end of the follow-up period (6.8 ± 3.7 months), all patients were alive and reported 227
no adverse events related to prophylactic balloon placement. No patients experienced or 228
developed pain at the site of balloon insertion, arteriovenous fistulas, deep vein thrombi or 229
pulmonary emboli during the follow-up period. All subsequent hospitalizations were unrelated to 230
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prophylactic balloon placement and attributed to the patients’ underlying disease. These 6 (29%) 231
hospitalizations included elective ICD re-implantation, lead revision, hematoma drainage, 232
cardioversion, and heart failure (Table 3. Follow-up Data). For all cases, there were no signs of 233
neurological deficits during the index hospitalization or at the minimum 3-month follow-up 234
period. 235
236
Discussion 237
238
The novel endovascular balloon was designed as a rapid response to exsanguination from 239
the superior vena cava. Swine models demonstrate the balloon can be deployed in under 2 240
minutes and stop up to 90% of blood loss.8 Comparative analysis of early clinical data showed 241
that patients were more likely to survive this catastrophic complication when the endovascular 242
balloon was properly utilized.4 243
However, the concept behind prophylactic placement is that an endovascular balloon 244
already situated within or near the target vessel can be deployed much more promptly than one 245
that is yet to be advanced over a stiff guidewire.6 Clancy and colleagues demonstrated in a swine 246
model that every second counts; a mere 2-cm tear along the SVC can rapidly hemorrhage at a 247
rate of 500 cc per minute, leading to complete exsanguination in under 10 minutes.8 In pre-248
procedural measurements conducted at our high-volume centers, the prophylactic placement 249
strategy considerably reduced deployment times to under 15 seconds. This spared approximately 250
90 seconds in deployment time as compared to a balloon that was available on the instrument 251
table, a difference which may prevent 750 cc of blood loss during a true complication. Thus, in 252
an emergent situation, a prophylactically placed balloon may swiftly occlude the SVC and 253
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provide hemostasis without delay, preventing critical complications such as cardiac tamponade 254
or hemothorax from progressing. Although this strategy has been described by several providers 255
utilizing an endovascular balloon during transvenous lead extraction,4 questions remain about 256
which patients would benefit most from having a balloon ready within the venae cavae. 257
There have been several attempts to stratify patients into risk categories for transvenous 258
lead extraction, efforts that may help identify patients who are at high-risk for endovascular 259
perforation and may be considered for prophylactic balloon placement. The 2009 HRS expert 260
consensus listed implant duration of the oldest lead, female gender, ICD lead removal, and the 261
use of powered tools as predictors of major complications.7 Moreover, in 2015, Fu and 262
colleagues at the Mayo Clinic classified patients as high-risk if they had a BMI of less than 25, 263
had pacemaker leads older than 10 years, or ICD leads older than 5 years.5 Bontempi and 264
colleagues describe the number of extracted leads, years since implant, the presence of active 265
fixation leads, and the presence of dual-coil, ICD leads as additional predictors of extraction 266
difficulty.9 Furthermore, low-volume extraction centers are associated with a greater risk for 267
complications and have been defined by the 2017 ELECTRa registry as centers that perform less 268
than 30 extractions per year.10 These data suggest that in addition to patient and lead 269
characteristics, an extractor’s experience plays a significant role in determining the risk of a 270
procedure. While prophylactic placement of an endovascular balloon is a clinical judgment made 271
by the extracting physician, these different risk classifications can be useful for centers to 272
develop a scheme on which patients would benefit most from this practice. Ultimately, having a 273
balloon available in the room and a team competent in proper usage of the device may be more 274
beneficial to rescue protocols than stratifying risk for prophylactic placement. 275
As the awareness and use of prophylactic placement has grown, some lead extractors 276
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have expressed reasonable hesitation in adopting such a practice in the absence of data attesting 277
to its safety. Preclinical regulatory data may ease some of these concerns, specifically regarding 278
the thrombotic risk of the balloon in the venae cavae. In accordance to FDA submission 279
requirements, the manufacturer of the endovascular balloon conducted a series of studies to 280
present preclinical safety data for premarket approval in 2015. In one such study (American 281
Preclinical Services, Minneapolis, MN, 2015), histopathological examination of swine 282
vasculature was performed after the balloon was deployed for 45 minutes following an SVC tear. 283
In 1 of 15 examined sections, clinically insignificant microthrombi measuring 10µm in diameter 284
were found attached to the luminal surface and were not determined to pose a safety risk; no 285
signs of thromboembolism were found in the heart or lungs upon gross necropsy evaluation. In a 286
separate study, in-vitro evaluations (Nelson Laboratories, Salt Lake City, UT, 2015) seemed to 287
corroborate the notion that the balloon does not pose a clinically significant thrombogenic risk. 288
Partial Thromboplastin Time testing in this study categorized the endovascular balloon material 289
as a “minimal activator of the intrinsic coagulation pathway,” scoring better than the legally 290
marketed device used as a control in the assay. Such biocompatibility tests are common and 291
standard protocol in the industry to evaluate the thrombogenic index of biomedical materials. 292
Despite these promising preclinical data, there are understandable limitations to generalizing 293
from animal and in-vitro models as no studies have been conducted to specifically assess the 294
thrombogenicity of the deflated balloon in the venae cavae. 295
Thus, early clinical data on the long-term effects of prophylactic balloon placement are 296
critical to elucidating the feasibility of this practice. In our two centers, we monitored 21 patients 297
for a minimum of 3 months to capture any adverse events following prophylactic placement. We 298
assessed for deep venous thrombi and pulmonary emboli; none of the patients reported any of 299
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these clinical conditions throughout the duration of the study. Hence, we have not observed any 300
evidence of clinical thromboembolic events that could be associated with prophylactic balloon 301
placement. 302
Vascular complications at access sites are another common concern for catheter-based 303
procedures such as insertion of an endovascular balloon. These could be minimized with 304
increased volume and experience of personnel performing the percutaneous venipuncture. The 305
use of vascular ultrasound is recommended to further decrease risk of vascular access 306
complications.11 Although venous sheath insertions are used in both prophylactic and emergency 307
balloon deployment, their complications are a possibility in both clinical situations. Throughout 308
the follow-up period of our study, we documented any issues related to femoral vascular access. 309
No patient reported pain at the site of balloon insertion nor presence of arteriovenous fistulas, 310
and physical examinations revealed complete recovery at sites of access. Alongside preclinical 311
data, our early clinical experience may inform providers on the use of the prophylactic strategy 312
and offer insight regarding its safety. 313
While not a central component of our study, our centers chose to inflate and deflate the 314
balloon in the SVC prior to the extraction. There are several possible advantages to this practice. 315
One advantage is that this could aid extractors in predetermining the volume of saline/contrast 316
mixture required to fully occlude the vessel. This practice also allows extraction teams to 317
document the optimal position of the device in the SVC in a non-emergent setting, thereby 318
reducing perioperative uncertainty. Moreover, extractors have an opportunity to assess the 319
patency, size, and shape of the SVC, factors that may help in both planning the procedure and 320
improving response times to complications. Above all, the time needed for balloon deployment 321
decreases with increased proficiency, familiarity, and level of experience with the device. 322
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Inflating and deflating the balloon prior to the procedure is an opportunity for extraction teams to 323
practice balloon deployment under optimal conditions, allowing team members to become well-324
versed in the device and its usage in a controlled setting.6 Altogether, this practice may help lead 325
extractors better prepare for complications by offering additional insight into a patient’s SVC 326
anatomy and fostering greater proficiency in deploying the rescue device. 327
Lastly, it is interesting to note that our two centers prophylactically placed the balloon in 328
different locations. While one center chose to withdraw the balloon into the IVC after deflation 329
and prior to lead extraction, the other preferred to leave the deflated balloon in the SVC. 330
Regardless of differences in institutional preferences, prophylactic placement did not preclude 331
either center from achieving success in these high-risk patients. Our centers were able to use a 332
combination of laser and mechanical extraction tools, while employing both subclavian and 333
femoral approaches, without compromising the integrity of the endovascular balloon in the venae 334
cavae. Overall, our most recent follow-up data show that for our study cohort, the prophylactic 335
placement of an endovascular balloon in the SVC and IVC was feasible and has not been 336
associated with any acute or long-term adverse outcomes. 337
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Study limitations 339
Due to the novelty of the endovascular balloon and the dependency of prophylactic 340
placement on the physician’s clinical judgment, this study is inherently limited by a small sample 341
size. The observations were nonrandomized, so the study sample was dependent upon the 342
number of high-risk patients who presented at our referral centers during the selected time frame. 343
Moreover, the facilities were high-volume centers for lead extraction, which may have reduced 344
the risk associated with this procedure. Therefore, our study does not necessarily reflect the 345
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outcomes and the level of risk that may be encountered at a low-volume center. The study is 346
further limited by the varying definitions in the literature for what constitutes a high-risk lead 347
extraction. This is because even the absence of high-risk indicators does not preclude the 348
possibility of an SVC tear, complicating which patients should be selected for prophylactic 349
placement. Additional studies that continue to assess the long-term effects of prophylactic 350
balloon placement are necessary to better understand the risks or benefits of this strategy. 351
352
Conclusions 353
354
During the study period from April 2016 to March 2017, we observed no acute or long-355
term adverse outcomes associated with prophylactic placement of an endovascular balloon in the 356
venae cavae of patients undergoing transvenous lead extraction. 357
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Tables 369
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Table 1. Demographics 371
Demographics (n = 21) Value Age, years 57.6 ± 18.7 Male sex 16 (76) Body mass index, kg/m2 26.1 ± 4.4 Caucasian race 14 (66) Comorbidities Coronary artery disease 7 (33) Diabetes mellitus 6 (29) Hypertension 14 (66) Chronic kidney disease 3 (14) Malignancy 2 (10) Prior open heart surgery 6 (29) NYHA Class I 5 (24) II 10 (48) III 6 (29) IV 0 (0) Ejection fraction, % 44.0 ± 11.5 Values are given as n (%) or mean ± SD 372
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Table 2. Device and Procedural Data 384
Device and Procedural Data (n = 21)
Value
Pacemaker 8 (38) ICD 7 (33) CRT-D 6 (29) Indication for extraction Infectious 8 (38) Non-infectious 13 (62) Lead dwell time, years 11.2 ± 8.3 Leads per case 2.2 ± 1.1 Abandoned leads 8 (38) Extracardiac leads 2 (10) Extraction tool Laser sheath 21 (100) Mechanical and laser sheaths 9 (43) Laser time, seconds 68.6 ± 13.0 Approach Subclavian 21 (100) Subclavian + Femoral 4 (19) Balloon placement SVC 10 (48) IVC 11 (52) Major complication Cardiac tamponade 1 (5) Minor complication Pocket hematomas 2 (10) Procedural success 21 (100%) Discharge survival 21 (100%) Values are given as n (%) or mean ± SD 385
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Table 3. Follow-up Data 394
Follow-up Data (n = 21) Value 3-month survival 21 (100) Pain at site of insertion 0 (0) AV fistula 0 (0) Deep vein thrombosis 0 (0) Pulmonary embolus 0 (0) Hospitalizations 6 (29) ICD re-implantation 1 (5) Lead revision 1 (5) Hematoma drainage 1 (5) Cardioversion 1 (5) Heart failure 2 (10) Values are given as n (%) 395
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Figure legends 412
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Figure 1: A) Stiff guidewire placed in the right internal jugular vein, B) Representative image 414
demonstrates the 12F introducer sheath with a prepared endovascular balloon 415
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Figure 2: A) The radiopaque markers of the endovascular balloon positioned in the SVC, B) The 417
radiopaque markers of the endovascular balloon positioned in the IVC 418
419
Figure 3: Slowly and smoothly inflated endovascular balloons at the SVC level in different 420
cases/anatomies prior to lead extraction 421
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Figure 4: A) Venography showing a near occlusion of the SVC, B) Venography showing a 423
complete occlusion of the SVC 424
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References 445
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