CREATIVE CONCEPTS
“Needle-in-needle” epicardial access: Preliminary observations with a modified technique for facilitating epicardial interventional procedures Saurabh Kumar, BSc(Med)/MBBS, PhD,* Raveen Bazaz, MD,† Chirag R. Barbhaiya, MD,* Alan D. Enriquez, MD,* Alan F. Helmbold, DO,* Jason S. Chinitz, MD,* Samuel H. Baldinger, MD,* Saagar Mahida, MD,* James W. McConville, RT,* Usha B. Tedrow, MD,* Roy M. John, MD, PhD,* Gregory F. Michaud, MD,* William G. Stevenson, MD* From the *Arrhythmia Unit, Cardiovascular Division, Brigham & Women’s Hospital, Boston, Massachusetts, and †Division of Cardiology, University of Pittsburgh, Pittsburgh, Pennsylvania.
Introduction 1
Since the original technique described by Sosa et al, percutaneous nonsurgical epicardial access has become an important adjunctive tool in the catheter ablation of ventricular tachycardias (VTs) and other arrhythmias.1–16 Significant pericardial bleeding (480 mL) is the most common complication of epicardial access, with a reported incidence ranging from 3.7% to 10%6,11,12,17,18 and is usually due to inadvertent right ventricular (RV) puncture, which may be severe enough to require surgical repair.6,11 Methods to improve safety are of interest.19–21 We previously attempted access with a long 21-gauge (G) micropuncture needle, believing that inadvertent cardiac or vascular puncture with this needle may be less likely to result in significant bleeding. However, it was sometimes challenging to direct the needle under the sternum because it tended KEYWORDS Epicardial access; Pericardial bleeding; Ventricular tachycardia; Atrial tachycardia; Supraventricular tachycardia ABBREVIATIONS BWH ¼ Brigham and Women’s Hospital; Fr ¼ French; G ¼ gauge; NIN ¼ needle-in-needle; RV ¼ right ventricle; UPMC ¼ University of Pittsburgh Medical Center; VT ¼ ventricular tachycardia (Heart Rhythm 2015;0:1–7) Dr. Kumar is a recipient of the Neil Hamilton Fairley Overseas Research scholarship co-funded by the National Health and Medical Research Council and the National Heart Foundation of Australia; and the Bushell Travelling Fellowship funded by the Royal Australasian College of Physicians. Dr. Tedrow receives consulting fees/honoraria from Boston Scientific Corp. and St. Jude Medical; and research funding from Biosense Webster Inc. and St. Jude Medical. Dr. John receives consulting fees/honoraria from St. Jude Medical. Dr. Michaud receives consulting fees/honoraria from Boston Scientific Corp., Medtronic Inc., and St. Jude Medical; and research funding from Boston Scientific Corp. and Biosense Webster Inc. Dr. William Stevenson is co-holder of a patent for needle ablation that is consigned to Brigham and Women’s Hospital. Address reprint requests and correspondence: Dr. William G. Stevenson, Cardiovascular Division, Brigham and Women’s Hospital, 75 Francis St, Boston, MA, 02115. E-mail address: [email protected].
1547-5271/$-see front matter B 2015 Heart Rhythm Society. All rights reserved.
to flex over the course of insertion, and tactile assessment of force and perception of cardiac motion was limited. In this report, we describe our initial experience with the “needle-inneedle” (NIN) technique of epicardial access in which a short 18G needle is inserted under the sternum and the long 21G needle is inserted through the 18G needle. It is hoped that this technique improves the stability of the small needle and potential tactile feedback, thus reducing the risk of significant pericardial bleeding. We report preliminary results of its procedural success and acute complications compared with the standard Sosa technique,1 which uses a 17G or 18G Touhy needle.
Methods Consecutive patients undergoing epicardial access for catheter ablation of atrial or ventricular arrhythmias or left atrial appendage closure from 2 centers (Brigham and Women’s Hospital, [BWH] and University of Pittsburgh Medical Center [UPMC]) were included in the study. Patients from BWH underwent these procedures between 1999 and 2014, whereas those from UPMC underwent procedures between 2007 and 2014. Patients who underwent epicardial access at these centers switched from the Sosa technique to the NIN technique in 2014. Thus, in this report, we compared outcomes of a prospectively collected cohort undergoing epicardial access using the NIN technique to a retrospective cohort who underwent epicardial access with the Sosa technique. All patients gave written informed consent for their procedure. At both hospitals, procedures were performed according to protocols approved by the Hospital’s Subject Protection Committee, and reporting of outcomes were in accordance with approvals granted by the Institutional Review Boards at both institutions. The present study overlaps and expands on the population reported from previous studies from the BWH.7,17,22 http://dx.doi.org/10.1016/j.hrthm.2015.03.045
2
Sosa technique of epicardial access The Sosa technique for percutaneous epicardial access has been previously described in detail.1 In brief, a 6-inch, 17G or 18G, 152-mm Tuohy needle (Hakko Cooperative Ltd, Chikuma-shi, Naganoken, Japan) was advanced below the xiphoid process under fluoroscopic guidance to the border of the cardiac silhouette. Small-volume contrast injection was used to identify the pericardium and confirm entry into the pericardial space. A guidewire was placed into the epicardial space, and a long sheath was advanced over the wire. The ablation catheter was then positioned in the epicardial space through the long sheath. The procedures were performed by 7 different operators with varying levels of experience.
Heart Rhythm, Vol 0, No 0, Month 2015 the sheath desired for introducing the catheter, usually a long steerable sheath (Agilis, St. Jude Medical, Minneapolis, MN) is inserted while retaining the remaining guidewire for introduction of a second sheath if desired, for example, for a balloon to protect the phrenic nerve (Figure 1V). Low-quality fluoroscopy was maintained during all parts of the epicardial access except in situations in which the NIN apparatus or the guidewire was not adequately visualized. In the latter situation, fluoroscopy dose was increased incrementally until the operator was comfortable with image quality. This increment in fluoroscopy dose was minimized to only the critical part of the procedure.
Outcomes NIN technique of epicardial access The NIN technique uses an 18G Cook needle (Percutaneous Entry Thinwall Needle, 18G, 7 cm, Cook Medical, Bloomington, IN) and a 21G micropuncture (Cook Medical) or long spinal needle (Chiba Biopsy needle 21G, 20 cm, Cook Medical; Figures 1A and 1B). The technique expands on that described by Sosa et al,1 with some important variations (see Online Supplementary Video). The technique involves the following: 1. Subxiphoid insertion of an 18G Cook needle is made through superficial tissue to a point just before the cardiac silhouette (Figure 1B). 2. A 21G micropuncture needle is inserted through the 18G Cook needle (Figures 1B and 1C). 3. The 21G needle alone is used to enter the pericardial space while maintaining the position of the Cook needle steady (Figure 1C) with the aid of contrast, fluoroscopy, and tactile sensation of entry into the pericardial space (Figures 1D-1G). 4. An 0.18G guidewire with a floppy tip (Hi Torque Steelcore 18 guidewire with microglide coating, 0.018 inch, 190 cm, Abbott Vascular, Santa Clara, CA) is advanced through the 21G needle into the pericardial space (Figure 1H-1J). As with the Sosa technique, confirmation that the wire is in the pericardial space is obtained by demonstrating on fluoroscopy that the wire crosses multiple cardiac chambers and hugs the border of the lateral left cardiac silhouette in the left anterior oblique projection (Figures 1K and 1L). 5. Both needles are removed (Figures 1M and 1N), and a micropuncture dilator is advanced into the pericardial space over the 0.18G guidewire (Figure 1O) and then exchanged for a 6 French (Fr) or 8Fr dilator (Figure 1P). 6. Confirmation of pericardial entry is again obtained with contrast and/or fluid aspiration (Figure 1Q). 7. The 0.18G guidewire is exchanged for a floppy-tip 0.35inch Bentson wire (Cook Medical; Figure 1R). 8. An 8Fr sheath with dilator is inserted over the 0.35-inch wire (Figure 1S). When maintaining the option for a second pericardial access, a second 0.35- or 0.32-inch wire is inserted into the 8Fr sheath (Figures 1T and 1U), the 8Fr sheath removed and
The following outcomes were compared between the 2 groups: (1) successful epicardial access; (2) incidence of major pericardial bleeding (defined as 480 mL of bleeding); and (3) incidence of other complications related to epicardial access (eg, injury to subdiaphragmatic vessels and abdominal viscera or coronary artery injury).
Statistical analysis The Statistical Package for the Social Sciences for Windows (release 22, IBM SPSS, Armonk, NY) was used for analysis. Continuous variables are expressed as mean ⫾ SD (normally distributed) or median with range (if not normally distributed). Mean values were compared using the Student t test if normally distributed. To test for associations between categorical variables, the χ2 test or Fisher exact test was used. A 2-tailed P o.05 was considered significant.
Results Baseline characteristics The study population comprised 314 patients in whom epicardial access was obtained, using the Sosa technique in 291 patients and the NIN technique in 23 patients (Table 1). There were no significant differences between the Sosa vs the NIN groups with regard to age, gender, body mass index, etiology of heart disease, left ventricular ejection fraction, or history of prior cardiac surgery (Table 1). Patients who underwent Sosa access were more likely to have VT as their procedural indication, whereas NIN patients had a more diverse spread of procedures, including ablation of premature ventricular contractions, left atrial appendage closure, epicardial phrenic nerve displacement procedures, and ablation of supraventricular tachycardia (Table 1).
Success rate of epicardial access Epicardial access attempts were successful in 297 of 316 procedures (94%) performed with the Sosa technique (266/ 291 patients [91%]). Epicardial access attempts were successful in 23 procedures performed with the NIN technique (23 patients [100%]; Table 1). Failure of epicardial access in the Sosa group were due to prior cardiac surgery (6) or adhesions from prior epicardial mapping/ablation or episodes of pericarditis (13).
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3
Major pericardial bleeding Major pericardial bleeding (480 mL) occurred in 28 of 316 procedures (8.9%) performed with the Sosa technique (28/291 patients [9.6%]; Table 1). Median estimated pericardial blood loss was 160 mL (range 80–300 mL).
A
MP
Major pericardial bleeding occurred in 2 of 23 procedures (8.7%) performed with the NIN technique (2/23 patients [8.7%], P ¼ 1 vs Sosa technique). Median estimated pericardial blood loss was 170 mL (range 100–240 mL).
C
His
ICE
Cook
B
F ICD lead Epicardial entry
SN MP Cook Cook
E
D
G Pericardial tenng
Epicardial contrast layering Contrast
H
I
J 0.18G guide wire 0.18G guide wire
NIN apparatus
L
K 0.18G guide wire
0.18G guide wire
Figure 1 Needle-in-needle (NIN) technique. See text for details. Fr ¼ French; G ¼ gauge; ICD ¼ implantable cardioverter-defibrillator; ICE ¼ intracardiac echocardiography; SN ¼ spinal needle; MP ¼ micropuncture.
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M
P
8Fr dilator
Q N NIN apparatus
0.18G guide wire
(J)
O
Pericardial fluid aspiraon
R
MP dilator
Bentsen wire
U
S
2nd wire
8 Fr short sheath
T
V “spare” wire
8 Fr short sheath dilator
Steerable sheath
Figure 1
Outcomes of major pericardial bleeding Of the patients who underwent epicardial access with the Sosa technique, 5 (1.7%) required operative intervention because of either RV perforation (4 patients) or coronary artery laceration (1 patient). In the remainder of patients, bleeding stopped spontaneously. Procedure-related death occurred in 3 patients (1%); 2 of 3 patients had operative intervention due to RV perforation. One patient died intraoperatively due to a significant RV laceration and hemodynamic deterioration. The second patient had successful repair of RV laceration but developed thrombosis of the left anterior descending coronary, recurrent VT, refractory heart failure, and sepsis and died during the same hospitalization. The third patient had an uncomplicated epicardial access and acutely successful ablation of recurrent VT but suffered a fatal pulmonary embolism the following day. In both instances of pericardial bleeding with the NIN technique, bleeding resolved without operative intervention.
(continued)
There were no procedure-related deaths. The first patient was a 27-year-old woman with an atrial tachycardia with site of origin overlying the right phrenic nerve who underwent epicardial access to protect the phrenic nerve during endocardial ablation. A long micropuncture needle was not of sufficient length to access the pericardial space, so a long spinal needle used. Because of a vertical orientation of the heart, pericardial access was challenging, requiring multiple attempts. Pericardial bleeding developed after insertion of the steerable sheath with 240 mL of blood aspirated from the pericardial space and autotransfused into the femoral sheath. The bleeding stopped spontaneously. The second patient was a 66-year-old man with ischemic cardiomyopathy and recurrent VT who had self-resolving, 100 mL of pericardial bleeding after insertion of the steerable sheath into the pericardial space. No NIN patient developed complications other rather pericardial bleeding but related to pericardial access.
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Table 1
Age (years) Male gender (%) Etiology of HD (%) Idiopathic Ischemic Nonischemic Left ventricular ejection fraction (%) Body mass index (kg/m2) Procedural indication, as percent of procedures Ventricular tachycardia Premature ventricular contractions Left atrial appendage closure Phrenic nerve displacement (atrial arrhythmias) Supraventricular tachycardia Prior cardiac surgery (no.) Successful epicardial access Any pericardial bleeding 480 mL Estimated pericardial blood loss (mL) [median (range)] Need for emergent cardiac surgery for pericardial bleeding Other complications related to pericardial access Procedure-related mortality
Sosa technique (n ¼ 291 patients, 316 procedures)
Needle-in-needle technique (n ¼ 23 patients, 23 procedures)
56 ⫾ 15 78
58 ⫾ 17 65
.6 .2
23 25 53 40 ⫾ 16 28 ⫾ 5
26 13 61 43 ⫾ 17 30 ⫾ 7
.4
93.8 2.1 1.7 2.1 1.7 4.5 297/316 procedures (94%) 28/316 procedures (8.9%) 160 (80–300) 5/297 patients (1.7%) 8/316 procedures (2.5%) 3/291 (1%)
65.2 4.3 17.3 8.7 17.4 4.3 23/23 procedures (100%) 2/23 procedures (8.7%) 170 (100-240) 0/24 patients (0%) 0 (0%) 0/23 (0%)
P value
.4 .2 o.001
1 .4 1 .7 1 1
Values are given as no. (%) or mean ⫾ SD unless otherwise indicated.
Other complications related to pericardial access Other complications related to pericardial access occurred in 8 of 316 procedures (2.5%) performed with the Sosa technique (8/291 patients [2.7%]; Table 1). These included coronary artery occlusion in 2, stroke in 2, pulmonary embolism in 1, inadvertent entry of the guidewire in 2, and sheath into the pleural space in 1 (patient who experienced moderate pericarditis). No other complication related to pericardial access occurred in 23 procedures performed with the NIN technique.
Sample size calculation for a prospective, randomized study We performed sample size calculations if a randomized comparison between the 2 techniques was to be pursued. Based on the occurrence of significant pericardial bleeding in 9.6% of Sosa technique patients, we estimated that 150 patients would be required in each arm to demonstrate a reduction in significant pericardial bleeding to an absolute rate of 2% of patients with the NIN technique (80% power, P o.05). This will likely require a multicenter effort over a significant period of time given that a recent multicenter study reported outcomes from 218 epicardial procedures that were accumulated from 6 centers over a period of 7 years.11
Discussion Percutaneous epicardial access has become an important tool for the mapping and ablation of complex arrhythmias after failed endocardial ablation and for access to the left atrial appendage for its closure.1–14,16 In arrhythmogenic RV dysplasia and idiopathic dilated cardiomyopathies, a high
incidence of epicardial substrate for ventricular arrhythmias is appreciated such that a endocardial/epicardial strategy may be applied during the first procedure.15,23 Previous multicenter studies of epicardial ablation have shown that major pericardial bleeding (480 mL) occurs in 3.7% to 10% of patients.6,11,12 Although some pericardial bleeding may be noted even in uncomplicated procedures, the amount usually is small (10–30 mL) and self-limiting (settles in 5–10 minutes).24 Significant pericardial bleeding may be due to RV laceration or laceration of a coronary arterial branch and can be severe enough to require operative intervention. In a European multicenter safety study, 2 of 8 patients developed cardiac tamponade after RV free-wall tear.11 Whereas some bleeding events may be due to failure to recognize inadvertent entry into the RV cavity and subsequent sheath insertion, some may be due to RV puncture with a larger-bore needle (eg, 17G or 18G Touhy) that does not resolve spontaneously. A number of techniques have been investigated to reduce the risk of pericardial bleeding during epicardial access, including multimodality image integration and assessment of changes in pressure frequency to recognize pericardial entry, with encouraging results from small series.19–21 Other technical variations have been clinically recognized, such as bending the 17G/18G needle to allow conformation to variant sternal anatomy and probing with the guidewire to exclude inadvertent RV entry, which represent important maneuvers for allowing safer epicardial access. In this study, we present “proof of concept” of a technique that represents a modification of the traditional approach of Sosa et al,1 which involves entry into the pericardial space with a 21G rather than a 17G or 18G needle, with the anticipation that if inadvertent RV puncture occurs, it is more
6 likely to settle spontaneously because of a smaller-diameter defect in the RV wall. Indeed, in the setting of left atrial appendage ligation with the LARIAT (SentreHEART, Redwood City, California) system, a recent multicenter survey reported that switching from the standard 18G needle to the micropuncture needle resulted in a dramatic reduction in rates of pericardial bleeding related to epicardial access.25 Although no significant difference in pericardial bleeding was found in our study, the sample size of the NIN group was small. Notably, no patient in the NIN group required urgent operative intervention for uncontrollable pericardial bleeding, but the index event rate for operative intervention in the comparative Sosa group was low (1.7% of patients). Furthermore, other complications related to pericardial access were not observed in the NIN group but occurred in 2.7% of patients in the Sosa group. Given the complexities of individual anatomy (eg, body habitus), disease substrates (eg, RV pathology such as wall thinning and aneurysm formation), and pericardial status (eg, prior adhesions), we performed power calculations, which revealed that approximately 150 patients will be required in each group to demonstrate reduction in risk of pericardial bleeding to 2% with the NIN compared to the Sosa technique. This is likely to require a multicenter prospective, randomized evaluation, noting that 2 prior large multicenter studies of epicardial access collated data from a range of 134 to 218 patients accumulated over a period of 6 to 8 years.6,11 Furthermore, it is likely that the risk with the Sosa technique is declining with increasing operator experience. Outside of randomized trial data, it is equally important, however, to recognize important procedural variations, such as the one reported in this study, which may allow safer epicardial access. Several disadvantages of the NIN technique are worthy of mention. First, we believed that the tactile sensation of pericardial entry (the “give”) was still not well appreciated with the NIN technique, so reliance on contrast injection was mandatory to confirm pericardial access. Second, the 0.18G floppy-tip guidewire may be difficult to visualize with the low-quality fluoroscopy used in the electrophysiology laboratory, thus necessitating an increased radiation dose for adequate visualization.
Study limitations Comparison of the retrospective Sosa technique patients to the prospective NIN technique patients introduces inherent measurement biases. Prospective randomized studies are needed to assess the validity of the NIN technique in reducing risk.
Conclusion This study provides proof of concept of a NIN technique, which was developed as a modification of the Sosa technique of epicardial access in the hope of reducing the risk of major pericardial bleeding during epicardial access. Larger randomized studies are needed to determine if the risks of
Heart Rhythm, Vol 0, No 0, Month 2015 the 2 techniques are different. Further development of methods to reduce the risks of epicardial access for electrophysiologic procedures is needed.
Appendix Supplementary data Supplementary material cited in this article is available online at http://dx.doi.org/10.1016/j.hrthm.2015.03.045.
References 1. Sosa E, Scanavacca M, d’Avila A, Pilleggi F. A new technique to perform epicardial mapping in the electrophysiology laboratory. J Cardiovasc Electrophysiol 1996;7:531–536. 2. d’Avila A, Koruth JS, Dukkipati S, Reddy VY. Epicardial access for the treatment of cardiac arrhythmias. Europace 2012;14(Suppl 2):ii13–ii18. 3. Di Biase L, Santangeli P, Burkhardt DJ, Bai R, Mohanty P, Carbucicchio C, Dello Russo A, Casella M, Mohanty S, Pump A, Hongo R, Beheiry S, Pelargonio G, Santarelli P, Zucchetti M, Horton R, Sanchez JE, Elayi CS, Lakkireddy D, Tondo C, Natale A. Endo-epicardial homogenization of the scar versus limited substrate ablation for the treatment of electrical storms in patients with ischemic cardiomyopathy. J Am Coll Cardiol 2012;60:132–141. 4. Lam C, Schweikert R, Kanagaratnam L, Natale A. Radiofrequency ablation of a right atrial appendage-ventricular accessory pathway by transcutaneous epicardial instrumentation. J Cardiovasc Electrophysiol 2000;11:1170–1173. 5. Reddy VY, Neuzil P, Ruskin JN. Extra-ostial pulmonary venous isolation: use of epicardial ablation to eliminate a point of conduction breakthrough. J Cardiovasc Electrophysiol 2003;14:663–666. 6. Sacher F, Roberts-Thomson K, Maury P, Tedrow U, Nault I, Steven D, Hocini M, Koplan B, Leroux L, Derval N, Seiler J, Wright MJ, Epstein L, Haissaguerre M, Jais P, Stevenson WG. Epicardial ventricular tachycardia ablation a multicenter safety study. J Am Coll Cardiol 2010;55:2366–2372. 7. Sarkozy A, Tokuda M, Tedrow UB, Sieria J, Michaud GF, Couper GS, John R, Stevenson WG. Epicardial ablation of ventricular tachycardia in ischemic heart disease. Circ Arrhythm Electrophysiol 2013;6:1115–1122. 8. Schweikert RA, Saliba WI, Tomassoni G, Marrouche NF, Cole CR, Dresing TJ, Tchou PJ, Bash D, Beheiry S, Lam C, Kanagaratnam L, Natale A. Percutaneous pericardial instrumentation for endo-epicardial mapping of previously failed ablations. Circulation 2003;108:1329–1335. 9. Tung R, Michowitz Y, Yu R, Mathuria N, Vaseghi M, Buch E, Bradfield J, Fujimura O, Gima J, Discepolo W, Mandapati R, Shivkumar K. Epicardial ablation of ventricular tachycardia: an institutional experience of safety and efficacy. Heart Rhythm 2013;10:490–498. 10. Miller MA, Gangireddy SR, Doshi SK, Aryana A, Koruth JS, Sennhauser S, d’Avila A, Dukkipati SR, Neuzil P, Reddy VY. Multicenter study on acute and long-term safety and efficacy of percutaneous left atrial appendage closure using an epicardial suture snaring device. Heart Rhythm 2014;11:1853–1859. 11. Della Bella P, Brugada J, Zeppenfeld K, Merino J, Neuzil P, Maury P, Maccabelli G, Vergara P, Baratto F, Berruezo A, Wijnmaalen AP. Epicardial ablation for ventricular tachycardia: a European multicenter study. Circ Arrhythm Electrophysiol 2011;4:653–659. 12. Sosa E, Scanavacca M. Epicardial mapping and ablation techniques to control ventricular tachycardia. J Cardiovasc Electrophysiol 2005;16:449–452. 13. Sosa E, Scanavacca M, d’Avila A, Oliveira F, Ramires JA. Nonsurgical transthoracic epicardial catheter ablation to treat recurrent ventricular tachycardia occurring late after myocardial infarction. J Am Coll Cardiol 2000;35:1442–1449. 14. Lee JC, Steven D, Roberts-Thomson KC, Raymond JM, Stevenson WG, Tedrow UB. Atrial tachycardias adjacent to the phrenic nerve: recognition, potential problems, and solutions. Heart Rhythm 2009;6:1186–1191. 15. Soejima K, Stevenson WG, Sapp JL, Selwyn AP, Couper G, Epstein LM. Endocardial and epicardial radiofrequency ablation of ventricular tachycardia associated with dilated cardiomyopathy: the importance of low-voltage scars. J Am Coll Cardiol 2004;43:1834–1842. 16. Scanavacca MI, Sternick EB, Pisani C, Lara S, Hardy C, d’Avila A, Correa FS, Darrieux F, Hachul D, Marcial MB, Sosa EA. Accessory atrioventricular pathways refractory to catheter ablation: role of percutaneous epicardial approach. Circ Arrhythm Electrophysiol 2015;8:128–136. 17. Roberts-Thomson KC, Seiler J, Steven D, Inada K, Michaud GF, John RM, Koplan BA, Epstein LM, Stevenson WG, Tedrow UB. Percutaneous access of the epicardial space for mapping ventricular and supraventricular arrhythmias in patients with and without prior cardiac surgery. J Cardiovasc Electrophysiol 2010;21:406–411.
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18. Yamada T. Transthoracic epicardial catheter ablation: indications, techniques, and complications. Circ J 2013;77:1672–1680. 19. Tung R, Shivkumar K. The value of image integration for epicardial catheter ablation of ventricular tachycardia. JACC Cardiovasc Imaging 2013;6:53–55. 20. Mahapatra S, Tucker-Schwartz J, Wiggins D, Gillies GT, Mason PK, McDaniel G, Lapar DJ, Stemland C, Sosa E, Ferguson JD, Bunch TJ, Ailawadi G, Scanavacca M. Pressure frequency characteristics of the pericardial space and thorax during subxiphoid access for epicardial ventricular tachycardia ablation. Heart Rhythm 2010;7:604–609. 21. Komatsu Y, Sacher F, Cochet H, Jais P. Multimodality imaging to improve the safety and efficacy of epicardial ablation of scar-related ventricular tachycardia. J Cardiovasc Electrophysiol 2013;24:1426–1427. 22. Kumar S, Barbhaiya C, Nagashima K, Choi EK, Epstein LM, John RM, Maytin M, Albert CM, Miller AL, Koplan BA, Michaud GF, Tedrow UB, Stevenson
7 WG. Ventricular tachycardia in cardiac sarcoidosis: characterization of ventricular substrate and outcomes of catheter ablation. Circ Arrhythm Electrophysiol 2015;8:87–93. 23. Philips B, Madhavan S, James C, Tichnell C, Murray B, Dalal D, Bhonsale A, Nazarian S, Judge DP, Russell SD, Abraham T, Calkins H, Tandri H. Outcomes of catheter ablation of ventricular tachycardia in arrhythmogenic right ventricular dysplasia/cardiomyopathy. Circ Arrhythm Electrophysiol 2012;5:499–505. 24. Lim HS, Sacher F, Cochet H, Berte B, Yamashita S, Mahida S, Zellerhoff S, Komatsu Y, Denis A, Derval N, Hocini M, Haissaguerre M, Jais P. Safety and prevention of complications during percutaneous epicardial access for the ablation of cardiac arrhythmias. Heart Rhythm 2014;11:1658–1665. 25. Rasekh A, Kar S, Nagaraj H, Badhwar N, Massumi A, Lakkireddy D. Differences in experience with a new delivery device for LAA Ligation among various U.S. cnters. J Am Coll Cardiol 2015;65:404–405.
“Needle-in-needle” epicardial access: Preliminary observations with a modified technique for facilitating epicardial interventional procedures Saurabh Kumar, BSc(Med)/MBBS, PhD,* Raveen Bazaz, MD,† Chirag R. Barbhaiya, MD,* Alan D. Enriquez, MD,* Alan F. Helmbold, DO,* Jason S. Chinitz, MD,* Samuel H. Baldinger, MD,* Saagar Mahida, MD,* James W. McConville, RT,* Usha B. Tedrow, MD,* Roy M. John, MD, PhD,* Gregory F. Michaud, MD,* William G. Stevenson, MD* From the *Arrhythmia Unit, Cardiovascular Division, Brigham & Women’s Hospital, Boston, Massachusetts, and †Division of Cardiology, University of Pittsburgh, Pittsburgh, Pennsylvania.
Introduction 1
Since the original technique described by Sosa et al, percutaneous nonsurgical epicardial access has become an important adjunctive tool in the catheter ablation of ventricular tachycardias (VTs) and other arrhythmias.1–16 Significant pericardial bleeding (480 mL) is the most common complication of epicardial access, with a reported incidence ranging from 3.7% to 10%6,11,12,17,18 and is usually due to inadvertent right ventricular (RV) puncture, which may be severe enough to require surgical repair.6,11 Methods to improve safety are of interest.19–21 We previously attempted access with a long 21-gauge (G) micropuncture needle, believing that inadvertent cardiac or vascular puncture with this needle may be less likely to result in significant bleeding. However, it was sometimes challenging to direct the needle under the sternum because it tended KEYWORDS Epicardial access; Pericardial bleeding; Ventricular tachycardia; Atrial tachycardia; Supraventricular tachycardia ABBREVIATIONS BWH ¼ Brigham and Women’s Hospital; Fr ¼ French; G ¼ gauge; NIN ¼ needle-in-needle; RV ¼ right ventricle; UPMC ¼ University of Pittsburgh Medical Center; VT ¼ ventricular tachycardia (Heart Rhythm 2015;0:1–7) Dr. Kumar is a recipient of the Neil Hamilton Fairley Overseas Research scholarship co-funded by the National Health and Medical Research Council and the National Heart Foundation of Australia; and the Bushell Travelling Fellowship funded by the Royal Australasian College of Physicians. Dr. Tedrow receives consulting fees/honoraria from Boston Scientific Corp. and St. Jude Medical; and research funding from Biosense Webster Inc. and St. Jude Medical. Dr. John receives consulting fees/honoraria from St. Jude Medical. Dr. Michaud receives consulting fees/honoraria from Boston Scientific Corp., Medtronic Inc., and St. Jude Medical; and research funding from Boston Scientific Corp. and Biosense Webster Inc. Dr. William Stevenson is co-holder of a patent for needle ablation that is consigned to Brigham and Women’s Hospital. Address reprint requests and correspondence: Dr. William G. Stevenson, Cardiovascular Division, Brigham and Women’s Hospital, 75 Francis St, Boston, MA, 02115. E-mail address: [email protected].
1547-5271/$-see front matter B 2015 Heart Rhythm Society. All rights reserved.
to flex over the course of insertion, and tactile assessment of force and perception of cardiac motion was limited. In this report, we describe our initial experience with the “needle-inneedle” (NIN) technique of epicardial access in which a short 18G needle is inserted under the sternum and the long 21G needle is inserted through the 18G needle. It is hoped that this technique improves the stability of the small needle and potential tactile feedback, thus reducing the risk of significant pericardial bleeding. We report preliminary results of its procedural success and acute complications compared with the standard Sosa technique,1 which uses a 17G or 18G Touhy needle.
Methods Consecutive patients undergoing epicardial access for catheter ablation of atrial or ventricular arrhythmias or left atrial appendage closure from 2 centers (Brigham and Women’s Hospital, [BWH] and University of Pittsburgh Medical Center [UPMC]) were included in the study. Patients from BWH underwent these procedures between 1999 and 2014, whereas those from UPMC underwent procedures between 2007 and 2014. Patients who underwent epicardial access at these centers switched from the Sosa technique to the NIN technique in 2014. Thus, in this report, we compared outcomes of a prospectively collected cohort undergoing epicardial access using the NIN technique to a retrospective cohort who underwent epicardial access with the Sosa technique. All patients gave written informed consent for their procedure. At both hospitals, procedures were performed according to protocols approved by the Hospital’s Subject Protection Committee, and reporting of outcomes were in accordance with approvals granted by the Institutional Review Boards at both institutions. The present study overlaps and expands on the population reported from previous studies from the BWH.7,17,22 http://dx.doi.org/10.1016/j.hrthm.2015.03.045
2
Sosa technique of epicardial access The Sosa technique for percutaneous epicardial access has been previously described in detail.1 In brief, a 6-inch, 17G or 18G, 152-mm Tuohy needle (Hakko Cooperative Ltd, Chikuma-shi, Naganoken, Japan) was advanced below the xiphoid process under fluoroscopic guidance to the border of the cardiac silhouette. Small-volume contrast injection was used to identify the pericardium and confirm entry into the pericardial space. A guidewire was placed into the epicardial space, and a long sheath was advanced over the wire. The ablation catheter was then positioned in the epicardial space through the long sheath. The procedures were performed by 7 different operators with varying levels of experience.
Heart Rhythm, Vol 0, No 0, Month 2015 the sheath desired for introducing the catheter, usually a long steerable sheath (Agilis, St. Jude Medical, Minneapolis, MN) is inserted while retaining the remaining guidewire for introduction of a second sheath if desired, for example, for a balloon to protect the phrenic nerve (Figure 1V). Low-quality fluoroscopy was maintained during all parts of the epicardial access except in situations in which the NIN apparatus or the guidewire was not adequately visualized. In the latter situation, fluoroscopy dose was increased incrementally until the operator was comfortable with image quality. This increment in fluoroscopy dose was minimized to only the critical part of the procedure.
Outcomes NIN technique of epicardial access The NIN technique uses an 18G Cook needle (Percutaneous Entry Thinwall Needle, 18G, 7 cm, Cook Medical, Bloomington, IN) and a 21G micropuncture (Cook Medical) or long spinal needle (Chiba Biopsy needle 21G, 20 cm, Cook Medical; Figures 1A and 1B). The technique expands on that described by Sosa et al,1 with some important variations (see Online Supplementary Video). The technique involves the following: 1. Subxiphoid insertion of an 18G Cook needle is made through superficial tissue to a point just before the cardiac silhouette (Figure 1B). 2. A 21G micropuncture needle is inserted through the 18G Cook needle (Figures 1B and 1C). 3. The 21G needle alone is used to enter the pericardial space while maintaining the position of the Cook needle steady (Figure 1C) with the aid of contrast, fluoroscopy, and tactile sensation of entry into the pericardial space (Figures 1D-1G). 4. An 0.18G guidewire with a floppy tip (Hi Torque Steelcore 18 guidewire with microglide coating, 0.018 inch, 190 cm, Abbott Vascular, Santa Clara, CA) is advanced through the 21G needle into the pericardial space (Figure 1H-1J). As with the Sosa technique, confirmation that the wire is in the pericardial space is obtained by demonstrating on fluoroscopy that the wire crosses multiple cardiac chambers and hugs the border of the lateral left cardiac silhouette in the left anterior oblique projection (Figures 1K and 1L). 5. Both needles are removed (Figures 1M and 1N), and a micropuncture dilator is advanced into the pericardial space over the 0.18G guidewire (Figure 1O) and then exchanged for a 6 French (Fr) or 8Fr dilator (Figure 1P). 6. Confirmation of pericardial entry is again obtained with contrast and/or fluid aspiration (Figure 1Q). 7. The 0.18G guidewire is exchanged for a floppy-tip 0.35inch Bentson wire (Cook Medical; Figure 1R). 8. An 8Fr sheath with dilator is inserted over the 0.35-inch wire (Figure 1S). When maintaining the option for a second pericardial access, a second 0.35- or 0.32-inch wire is inserted into the 8Fr sheath (Figures 1T and 1U), the 8Fr sheath removed and
The following outcomes were compared between the 2 groups: (1) successful epicardial access; (2) incidence of major pericardial bleeding (defined as 480 mL of bleeding); and (3) incidence of other complications related to epicardial access (eg, injury to subdiaphragmatic vessels and abdominal viscera or coronary artery injury).
Statistical analysis The Statistical Package for the Social Sciences for Windows (release 22, IBM SPSS, Armonk, NY) was used for analysis. Continuous variables are expressed as mean ⫾ SD (normally distributed) or median with range (if not normally distributed). Mean values were compared using the Student t test if normally distributed. To test for associations between categorical variables, the χ2 test or Fisher exact test was used. A 2-tailed P o.05 was considered significant.
Results Baseline characteristics The study population comprised 314 patients in whom epicardial access was obtained, using the Sosa technique in 291 patients and the NIN technique in 23 patients (Table 1). There were no significant differences between the Sosa vs the NIN groups with regard to age, gender, body mass index, etiology of heart disease, left ventricular ejection fraction, or history of prior cardiac surgery (Table 1). Patients who underwent Sosa access were more likely to have VT as their procedural indication, whereas NIN patients had a more diverse spread of procedures, including ablation of premature ventricular contractions, left atrial appendage closure, epicardial phrenic nerve displacement procedures, and ablation of supraventricular tachycardia (Table 1).
Success rate of epicardial access Epicardial access attempts were successful in 297 of 316 procedures (94%) performed with the Sosa technique (266/ 291 patients [91%]). Epicardial access attempts were successful in 23 procedures performed with the NIN technique (23 patients [100%]; Table 1). Failure of epicardial access in the Sosa group were due to prior cardiac surgery (6) or adhesions from prior epicardial mapping/ablation or episodes of pericarditis (13).
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Major pericardial bleeding Major pericardial bleeding (480 mL) occurred in 28 of 316 procedures (8.9%) performed with the Sosa technique (28/291 patients [9.6%]; Table 1). Median estimated pericardial blood loss was 160 mL (range 80–300 mL).
A
MP
Major pericardial bleeding occurred in 2 of 23 procedures (8.7%) performed with the NIN technique (2/23 patients [8.7%], P ¼ 1 vs Sosa technique). Median estimated pericardial blood loss was 170 mL (range 100–240 mL).
C
His
ICE
Cook
B
F ICD lead Epicardial entry
SN MP Cook Cook
E
D
G Pericardial tenng
Epicardial contrast layering Contrast
H
I
J 0.18G guide wire 0.18G guide wire
NIN apparatus
L
K 0.18G guide wire
0.18G guide wire
Figure 1 Needle-in-needle (NIN) technique. See text for details. Fr ¼ French; G ¼ gauge; ICD ¼ implantable cardioverter-defibrillator; ICE ¼ intracardiac echocardiography; SN ¼ spinal needle; MP ¼ micropuncture.
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M
P
8Fr dilator
Q N NIN apparatus
0.18G guide wire
(J)
O
Pericardial fluid aspiraon
R
MP dilator
Bentsen wire
U
S
2nd wire
8 Fr short sheath
T
V “spare” wire
8 Fr short sheath dilator
Steerable sheath
Figure 1
Outcomes of major pericardial bleeding Of the patients who underwent epicardial access with the Sosa technique, 5 (1.7%) required operative intervention because of either RV perforation (4 patients) or coronary artery laceration (1 patient). In the remainder of patients, bleeding stopped spontaneously. Procedure-related death occurred in 3 patients (1%); 2 of 3 patients had operative intervention due to RV perforation. One patient died intraoperatively due to a significant RV laceration and hemodynamic deterioration. The second patient had successful repair of RV laceration but developed thrombosis of the left anterior descending coronary, recurrent VT, refractory heart failure, and sepsis and died during the same hospitalization. The third patient had an uncomplicated epicardial access and acutely successful ablation of recurrent VT but suffered a fatal pulmonary embolism the following day. In both instances of pericardial bleeding with the NIN technique, bleeding resolved without operative intervention.
(continued)
There were no procedure-related deaths. The first patient was a 27-year-old woman with an atrial tachycardia with site of origin overlying the right phrenic nerve who underwent epicardial access to protect the phrenic nerve during endocardial ablation. A long micropuncture needle was not of sufficient length to access the pericardial space, so a long spinal needle used. Because of a vertical orientation of the heart, pericardial access was challenging, requiring multiple attempts. Pericardial bleeding developed after insertion of the steerable sheath with 240 mL of blood aspirated from the pericardial space and autotransfused into the femoral sheath. The bleeding stopped spontaneously. The second patient was a 66-year-old man with ischemic cardiomyopathy and recurrent VT who had self-resolving, 100 mL of pericardial bleeding after insertion of the steerable sheath into the pericardial space. No NIN patient developed complications other rather pericardial bleeding but related to pericardial access.
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Table 1
Age (years) Male gender (%) Etiology of HD (%) Idiopathic Ischemic Nonischemic Left ventricular ejection fraction (%) Body mass index (kg/m2) Procedural indication, as percent of procedures Ventricular tachycardia Premature ventricular contractions Left atrial appendage closure Phrenic nerve displacement (atrial arrhythmias) Supraventricular tachycardia Prior cardiac surgery (no.) Successful epicardial access Any pericardial bleeding 480 mL Estimated pericardial blood loss (mL) [median (range)] Need for emergent cardiac surgery for pericardial bleeding Other complications related to pericardial access Procedure-related mortality
Sosa technique (n ¼ 291 patients, 316 procedures)
Needle-in-needle technique (n ¼ 23 patients, 23 procedures)
56 ⫾ 15 78
58 ⫾ 17 65
.6 .2
23 25 53 40 ⫾ 16 28 ⫾ 5
26 13 61 43 ⫾ 17 30 ⫾ 7
.4
93.8 2.1 1.7 2.1 1.7 4.5 297/316 procedures (94%) 28/316 procedures (8.9%) 160 (80–300) 5/297 patients (1.7%) 8/316 procedures (2.5%) 3/291 (1%)
65.2 4.3 17.3 8.7 17.4 4.3 23/23 procedures (100%) 2/23 procedures (8.7%) 170 (100-240) 0/24 patients (0%) 0 (0%) 0/23 (0%)
P value
.4 .2 o.001
1 .4 1 .7 1 1
Values are given as no. (%) or mean ⫾ SD unless otherwise indicated.
Other complications related to pericardial access Other complications related to pericardial access occurred in 8 of 316 procedures (2.5%) performed with the Sosa technique (8/291 patients [2.7%]; Table 1). These included coronary artery occlusion in 2, stroke in 2, pulmonary embolism in 1, inadvertent entry of the guidewire in 2, and sheath into the pleural space in 1 (patient who experienced moderate pericarditis). No other complication related to pericardial access occurred in 23 procedures performed with the NIN technique.
Sample size calculation for a prospective, randomized study We performed sample size calculations if a randomized comparison between the 2 techniques was to be pursued. Based on the occurrence of significant pericardial bleeding in 9.6% of Sosa technique patients, we estimated that 150 patients would be required in each arm to demonstrate a reduction in significant pericardial bleeding to an absolute rate of 2% of patients with the NIN technique (80% power, P o.05). This will likely require a multicenter effort over a significant period of time given that a recent multicenter study reported outcomes from 218 epicardial procedures that were accumulated from 6 centers over a period of 7 years.11
Discussion Percutaneous epicardial access has become an important tool for the mapping and ablation of complex arrhythmias after failed endocardial ablation and for access to the left atrial appendage for its closure.1–14,16 In arrhythmogenic RV dysplasia and idiopathic dilated cardiomyopathies, a high
incidence of epicardial substrate for ventricular arrhythmias is appreciated such that a endocardial/epicardial strategy may be applied during the first procedure.15,23 Previous multicenter studies of epicardial ablation have shown that major pericardial bleeding (480 mL) occurs in 3.7% to 10% of patients.6,11,12 Although some pericardial bleeding may be noted even in uncomplicated procedures, the amount usually is small (10–30 mL) and self-limiting (settles in 5–10 minutes).24 Significant pericardial bleeding may be due to RV laceration or laceration of a coronary arterial branch and can be severe enough to require operative intervention. In a European multicenter safety study, 2 of 8 patients developed cardiac tamponade after RV free-wall tear.11 Whereas some bleeding events may be due to failure to recognize inadvertent entry into the RV cavity and subsequent sheath insertion, some may be due to RV puncture with a larger-bore needle (eg, 17G or 18G Touhy) that does not resolve spontaneously. A number of techniques have been investigated to reduce the risk of pericardial bleeding during epicardial access, including multimodality image integration and assessment of changes in pressure frequency to recognize pericardial entry, with encouraging results from small series.19–21 Other technical variations have been clinically recognized, such as bending the 17G/18G needle to allow conformation to variant sternal anatomy and probing with the guidewire to exclude inadvertent RV entry, which represent important maneuvers for allowing safer epicardial access. In this study, we present “proof of concept” of a technique that represents a modification of the traditional approach of Sosa et al,1 which involves entry into the pericardial space with a 21G rather than a 17G or 18G needle, with the anticipation that if inadvertent RV puncture occurs, it is more
6 likely to settle spontaneously because of a smaller-diameter defect in the RV wall. Indeed, in the setting of left atrial appendage ligation with the LARIAT (SentreHEART, Redwood City, California) system, a recent multicenter survey reported that switching from the standard 18G needle to the micropuncture needle resulted in a dramatic reduction in rates of pericardial bleeding related to epicardial access.25 Although no significant difference in pericardial bleeding was found in our study, the sample size of the NIN group was small. Notably, no patient in the NIN group required urgent operative intervention for uncontrollable pericardial bleeding, but the index event rate for operative intervention in the comparative Sosa group was low (1.7% of patients). Furthermore, other complications related to pericardial access were not observed in the NIN group but occurred in 2.7% of patients in the Sosa group. Given the complexities of individual anatomy (eg, body habitus), disease substrates (eg, RV pathology such as wall thinning and aneurysm formation), and pericardial status (eg, prior adhesions), we performed power calculations, which revealed that approximately 150 patients will be required in each group to demonstrate reduction in risk of pericardial bleeding to 2% with the NIN compared to the Sosa technique. This is likely to require a multicenter prospective, randomized evaluation, noting that 2 prior large multicenter studies of epicardial access collated data from a range of 134 to 218 patients accumulated over a period of 6 to 8 years.6,11 Furthermore, it is likely that the risk with the Sosa technique is declining with increasing operator experience. Outside of randomized trial data, it is equally important, however, to recognize important procedural variations, such as the one reported in this study, which may allow safer epicardial access. Several disadvantages of the NIN technique are worthy of mention. First, we believed that the tactile sensation of pericardial entry (the “give”) was still not well appreciated with the NIN technique, so reliance on contrast injection was mandatory to confirm pericardial access. Second, the 0.18G floppy-tip guidewire may be difficult to visualize with the low-quality fluoroscopy used in the electrophysiology laboratory, thus necessitating an increased radiation dose for adequate visualization.
Study limitations Comparison of the retrospective Sosa technique patients to the prospective NIN technique patients introduces inherent measurement biases. Prospective randomized studies are needed to assess the validity of the NIN technique in reducing risk.
Conclusion This study provides proof of concept of a NIN technique, which was developed as a modification of the Sosa technique of epicardial access in the hope of reducing the risk of major pericardial bleeding during epicardial access. Larger randomized studies are needed to determine if the risks of
Heart Rhythm, Vol 0, No 0, Month 2015 the 2 techniques are different. Further development of methods to reduce the risks of epicardial access for electrophysiologic procedures is needed.
Appendix Supplementary data Supplementary material cited in this article is available online at http://dx.doi.org/10.1016/j.hrthm.2015.03.045.
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