J A C C : C L I N I C A L E L E C T R O P H Y S I O L O G Y VO L . - , N O . - , 2 0 1 8

ª 2 0 1 8 B Y T H E AM E R I C A N C O L L E G E O F C A R D I O L O G Y F O UN DA T I O N

P U B L I S H E D B Y E L S E V I E R

Bailout Atrial Balloon Septoplasty toOvercome Challenging Left AtrialTransseptal Access for Catheter Ablationof Atrial Fibrillation

Jackson J. Liang, DO,a Sanghamitra Mohanty, MD, MS,a Joe Fahed, MD,a Daniele Muser, MD,a David F. Briceno, MD,a

J. David Burkhardt, MD,b Jeffrey S. Arkles, MD,a Gregory E. Supple, MD,a David S. Frankel, MD,a

Saman Nazarian, MD, PHD,a Fermin C. Garcia, MD,a David J. Callans, MD,a Sanjay Dixit, MD,a

Luigi Di Biase, MD, PHD,b,c Andrea Natale, MD,b Francis E. Marchlinski, MD,a Pasquale Santangeli, MD, PHDa

ABSTRACT

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OBJECTIVES This study reports outcomes of bailout atrial balloon septoplasty (ABS) to overcome challenging left

atrial (LA) access in patients undergoing atrial fibrillation (AF) ablation.

BACKGROUND Transseptal puncture (TSP) and LA access for AF ablation can be challenging in patients with prior atrial

septal surgery, percutaneous closure, or scarred septum due to multiple prior TSPs.

METHODS The study identified patients who underwent AF ablation at 2 ablation centers from 2011 to 2017 with

challenging TSP in whom bailout percutaneous ABS was performed to allow LA access. Following TSP, the transseptal

sheath could not be advanced to the LA despite multiple attempts or approaches including use of a stiff wire sequentially

in the left and right pulmonary veins, use of a stiff pigtail exchange wire advanced in the LA or left ventricle, or sequential

dilation with progressively larger diameter long dilators. ABS was performed using a noncompliant balloon (diameter 4 to

10 mm) advanced over a stiff wire deployed in the left superior pulmonary vein, allowing passage of the transseptal

sheaths for completion of the AF ablation procedure.

RESULTS Fifteen patients (mean age 54.4 � 15.5 years, 9 women) with challenging TSP (7 patients with prior surgical

ASD repair, 2 with percutaneous ASD closure devices, and 13 with $1 previous TSP) underwent bailout ABS for AF

ablation. After TSP (radiofrequency assisted in 10 cases), ABS was successful and permitted access to the LA for ablation

in all patients. Mean time required to perform ABS was 21.3 � 19.4 min, and mean total procedure time was 241.1 � 114.6

min (fluoroscopy time 62.0 � 29.9 min). There were no procedural complications.

CONCLUSIONS In patients undergoing AF ablation with difficult transseptal access due to scarred, surgically, or

percutaneously repaired atrial septum, ABS is a safe and effective bailout strategy to obtain transseptal access. (J Am

Coll Cardiol EP 2018;-:-–-) © 2018 by the American College of Cardiology Foundation.

N 2405-500X/$36.00 https://doi.org/10.1016/j.jacep.2018.04.003

m the aDivision of Cardiology, Electrophysiology Section, Hospital of the University of Pennsylvania, Philadelphia, Pennsyl-

nia; bTexas Cardiac Arrhythmia Institute, Austin, Texas; and the cMontefiore Medical Center, Albert Einstein College of Med-

ne, New York, New York. Dr. Nazarian has served as a consultant for Biosense Webster, CardioSolv, and Siemens; and has

eived research grant support from Biosense Webster. Dr. Di Biase has served as a consultant for Biosense Webster, Stereotaxis,

ston Scientific, and Abbott; and has received speaker/travel honoraria from Medtronic, Pfizer, and Biotronik. Dr. Natale has

eived consulting fees/honoraria from Biosense Webster, Inc., St. Jude Medical, Medtronic, and Boston Scientific. All other

thors have reported that they have no relationships relevant to the contents of this paper to disclose.

authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’

titutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information,

it the JACC: Clinical Electrophysiology author instructions page.

nuscript received December 18, 2017; revised manuscript received February 26, 2018, accepted April 5, 2018.

ABBR EV I A T I ON S

AND ACRONYMS

ABS = atrial balloon

septoplasty

AF = atrial fibrillation

ASD = atrial septal defect

ICE = intracardiac

echocardiography

LA = left atrium/atrial

LSPV = left superior

pulmonary vein

PVI = pulmonary vein isolation

TSP = transseptal puncture

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C atheter ablation is an effective andwidely accepted treatment optionfor patients with atrial fibrillation

(AF) refractory to antiarrhythmic drugs (1,2).Pulmonary vein isolation (PVI) is the corner-stone for AF ablation and access to the leftatrium (LA) via transseptal puncture (TSP) isnecessary to perform PVI. Patients whohave undergone prior AF ablation may haveseptal scarring and thickening at the sites ofprior transseptal access, complicating repeatTSP (3,4). Additionally, TSP may be difficultin patients who have previously undergonesurgical or percutaneous repair for atrial

septal defects (ASDs). Furthermore, certain ablationplatforms such as cryoballoon ablation may requirelarger sheaths which can be challenging to advancethrough the septum. Isolated case reports havedescribed the use of atrial balloon septoplasty (ABS)to dilate the access site and allow successful passageof the sheath to the LA (5–7). However, the efficacyand safety of ABS to obtain LA access in larger patientcohorts remains unknown. We report a series of pa-tients undergoing catheter ablation of AF with chal-lenging TSP in whom bailout ABS was performed toobtain LA access.

METHODS

PATIENT INCLUSION. We identified all patients inwhom ABS was performed to allow for transseptalaccess during AF ablation procedures at the Hospitalof the University of Pennsylvania and the Texas Car-diac Arrhythmia Institute. Baseline clinical and de-mographic information and details of the AF ablationprocedure were collected from patient medical re-cords. All patients signed a written informed consentaccording to institutional guidelines at both centers,and data entered in the corresponding institutionalregistries were approved by the respective centers’Investigational Review Boards.

AF ABLATION PROCEDURE. The standard mappingand AF ablation techniques at both centers have beendescribed previously (8,9). All patients were broughtto the electrophysiology lab in the fasting state andelectrocardiographic and hemodynamic monitoringwas initiated. Patients were prepped and draped inthe usual sterile fashion. General anesthesia withintubation and mechanical ventilation was used in allcases, with the addition of high-frequency jet venti-lation for the cases performed at the Hospital of theUniversity of Pennsylvania. Femoral venous (or in-ternal jugular venous) access was obtained via

modified Seldinger technique under ultrasoundguidance and radial arterial access was obtained forcontinuous blood pressure monitoring throughoutthe case. A diagnostic intracardiac echocardiography(ICE) catheter (8-F, AcuNav, Biosense Webster, Dia-mond Bar, California) was advanced into the rightatrium via the left femoral vein. A decapolar catheterwas placed along the posterior right atrium from theleft femoral vein. The coronary sinus catheter typeand access approach differed between the 2 centers(either a decapolar catheter from the left femoral veinor a 20-pole catheter from the right internal jugularvein). The technique for transseptal access includingbailout ABS is described in detail subsequently. Aftertransseptal access was obtained, electroanatomicmapping and radiofrequency ablation was performedusing wide antral PVI together with ablation ofspontaneous or inducible non-PV triggers (10,11). Thetechniques for induction and localization of non-PVtriggers have been described in detail previously(11). In brief, all patients underwent infusion of highdoses of isoproterenol (up to 20 to 30 mg/min) toinduce non-PV triggers. Atrial burst pacing and car-dioversion of spontaneous/inducible AF togetherwith infusion of isoproterenol was also performed fornon-PV trigger induction in cases done at the Hospitalof the University of Pennsylvania (11). In 1 patient PVIwas performed using a 28-mm Arctic Front Advance(Medtronic, Minneapolis, Minnesota) cryoballoonablation catheter as previously described (12).

TRANSSEPTAL ACCESS AND ABS. Intravenous hep-arin was administered before the transseptal access toobtain a target activated clotting time of >300 s. Dou-ble (n¼ 13) or single (n¼ 2) TSPwas performed from theright femoral vein to facilitate LA ablation. For casesutilizing radiofrequency ablation, 2 long 8.5-F trans-septal sheaths (Agilis [8.5-F] and SL-1 [8.5-F] or SL-0 [8.5-F] and LAMP-90 [8.5-F], St. Jude Medical, St.Paul, Minnesota) were advanced over a long guidewireto the superior vena cava under fluoroscopic guidance.In 1 patient, single transseptal access was obtainedusing an 8.5-F Merit HeartSpan sheath (Merit MedicalSystems, South Jordan, Utah). In the patient who un-derwent cryoballoon ablation, a FlexCath Advancesteerable sheath (12-F inner diameter, 15-F outerdiameter; Medtronic) was advanced over a stiff ex-change wire positioned in the left superior PV (LSPV)once LA access was obtained with an SL-1 sheath usingthe technique described subsequently. A flushed BRKtransseptal needle (St. Jude Medical) or a radio-frequency transseptal needle (NRG Transseptal Nee-dle, Baylis Medical, Montreal, Canada) was introducedinto the Agilis/SL-0/SL-1 sheaths, and the entire

FIGURE 1 Sequential Fluoroscopic Images Demonstrating Atrial Balloon Septoplasty Technique

(A, B) The transseptal dilator is in the left atrium (LA) and a stiff wire (Amplatz) has been advanced to the left superior pulmonary valve (LSPV). Advancement of the

sheath over the dilator was not possible (asterisk) and resulted in buckling of the sheath over the dilator at the transseptal access site. (C) The dilator has been pulled

back and the sheath is positioned in the mid right atrium with the stiff wire positioned in the LSPV. A deflated 6-mm-diameter angioplasty balloon (arrows) is advanced

over the wire through the septostomy site with the distal end in the LA and the proximal end in the right atrium. (D) Dilation of the balloon (asterisk) at 10 atm for 30 s

with evidence of indentation (arrows) representing the septostomy site being dilated. (E) Completely expanded angioplasty balloon (asterisk) after 30-s inflation with

absence of previously visualized indentation, confirming complete and effective atrial balloon septoplasty. (F) The balloon is deflated and the transseptal sheath is

advanced over the balloon (asterisk) through the septostomy site without difficulty. See Online Video 1. ABL ¼ ablation catheter.

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system was gently withdrawn under orthogonal fluo-roscopic and ICE visualization. The optimal site of TSPaccess, as determined with ICE imaging, typicallycorresponded to the posteroinferior portion of thefossa ovalis with far-field visualization of the left PVs.A slightly more anterior access was performed in thepatient who underwent cryoballoon ablation. Crossingof the interatrial septum with the needle was verifiedwith ICE, fluoroscopy, and LA pressure recording;advancement of the transseptal dilator over the needlewas possible in all cases. However, significant resis-tance was encountered when attempting to advancethe transseptal sheath over the dilator and needle(Online Video 1). At this point the following strategieswere sequentially attempted: a 0.0350 0 stiff guidewire(Amplatz Super Stiff, Boston Scientific, Marlborough,Massachusetts; or Amplatz Extra-Stiff, Cook MedicalInc., Bloomington, Indiana) was advanced into the

LSPV followed by the right superior PV, or a 0.025-inchstiff pigtail exchange guidewire (TorayGuide guide-wire, Toray Group, Toray Industries, Inc., Tokyo,Japan; or Protrack, BaylisMedical) was advanced to theLA or left ventricle to provide more support to thedilator and facilitate the advancement of the sheath inthe LA. In 4 patients, additional attempts at sequentialdilation using progressively larger diameter (9-F, 11-F,then 14-F) long dilators advanced over a stiff guidewirepositioned into the LSPV were also performed. If thesheath still could not pass through the septum, ABSwas attempted (Online Video 1). A stiff guidewire (260-cm Amplatz Super Stiff, Amplatz Extra-Stiff, Protrack,or TorayGuide) was advanced to the LSPV (Amplatzwire) or LA (Protrack or TorayGuide wire), the dilatorwas pulled back, and the sheath was positioned in themid right atrium. A noncompliant 0.035-inch POW-ERFLEX Pro PTA Dilation Catheter (diameter 4 to 10

FIGURE 2 Sequential Intracardiac Echocardiography Images Demonstrating Atrial Balloon Septoplasty Technique

(A) The transseptal needle (asterisk) and dilator tip are easily advanced through the transseptal puncture site. (B) After failed attempts to

advance the sheath across the septostomy, a stiff pigtail guide wire (arrow) has been inserted, over which the dilator and sheath are advanced.

The dilator has been pulled back and the sheath (asterisk) continues to tent the septum, unable to pass through the septostomy. (C) After

advancing a 6-mm-diameter angioplasty balloon across the septostomy, the balloon is inflated (arrows) and the septoplasty is performed. (D)

After balloon deflation, the transseptal sheath (asterisk) is easily advanced into the left atrium.

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mm, length 2 to 15 cm; Cordis, Milpitas, California) wasadvanced over the wire through the sheath and posi-tioned across the septum as visualized with fluoros-copy and ICE. The balloonwas fully or partially inflatedunder fluoroscopic and direct ICE visualization toassess for septostomy dilation. Once the septostomysite was appropriately dilated, the balloon wasdeflated and the sheath was advanced over the balloonand wire in the left atrium (Online Video 1). Figures 1and 2 show sequential fluoroscopic and ICE images,respectively, demonstrating the ABS technique.

FOLLOW-UP. After ablation, patients were monitoredin the hospital for at least 1 day and assessed forprocedural complications. Transthoracic echocardio-grams were not routinely performed for asymptom-atic patients before hospital discharge. Standardpost-ablation follow-up included provider visits at 6weeks, 6 months, and 1 year post-ablation.

RESULTS

STUDY POPULATION. Between March 2012 andNovember 2017, of 8,682 patients undergoing AF

ablation at our institutions, 15 (0.17%) patients un-derwent bailout ABS to obtain transseptal access(mean age 54.4 � 15.5 years, 9 women). Ten (66.7%) ofthese patients underwent catheter ablation for non-paroxysmal forms of AF or atypical flutter. Mean LAdiameter was 5.0 � 0.7 cm and mean left ventricularejection fraction was 59.7 � 7.1%. Clinical and de-mographic characteristics for all patients are listed inTable 1. Seven patients had undergone prior opensurgical ASD repair, in 2 of whom a GORE-TEX softtissue patch (W.L. Gore & Associates, Inc., Newark,Delaware) was used. Two patients had undergonepercutaneous ASD closure with Amplatzer devices. Atleast 1 prior procedure involving TSP had been previ-ously performed in 13 patients (1 prior procedure in 3patients, 2 procedures in 6 patients, and 3 proceduresin 4 patients). In 2 patients, no prior cardiac surgery/closure device or TSP procedures had been performed(Patients #3 and #8) (Table 1): 1 of these patients hadsevere lipomatous infiltration of the interatrialseptum and there was difficulty passing the largercryoballoon transseptal sheath, whereas the other hadevidence of severely aneurysmal interatrial septum.

TABLE 1 Clinical and Demographic Characteristics of Patients Undergoing ABS During AF Ablation

Patient Age (yrs) Sex HTN DM AF TypeLA

Diameter (mm) LVEF (%)

Number of PriorTransseptalProcedures

Closure Device/PriorCardiac Surgery

1 76 F Y N Persistent 46 61 3 N/A

2 67 F N N Persistent 51 55 3 Surgical GORE-TEX ASD repair

3 71 M Y N Paroxysmal N/A 64 0 N/A*

4 25 F N N Persistent 58 60 1 Shone’s syndrome status post-VSD repairand bioprosthetic MV replacement,LA appendage ligation and Maze,prior transseptal MV leak repair

5 64 M Y N Persistent 45 60 2 N/A

6 61 F Y N Persistent 61 56 0 Pericardial patch repair of secundumASD, LA Maze

7 69 M Y N Persistent N/A 60 1 CABG surgery

8 62 F Y N Paroxysmal 40 60 0 N/A†

9 64 F Y N Persistent 57 50 3 Surgical ASD repair

10 33 M N N Persistent 48 45 2 Surgical GORE-TEX ASD repair

11 34 M N N Paroxysmal 43 65 2 Surgical ASD repair

12 48 F Y Y Persistent N/A 75 1 Percutaneous ASD closure (Amplatzer)

13 44 M N N Paroxysmal N/A 60 3 Surgical ASD repair

14 47 F N Y Persistent N/A 65 2 Percutaneous ASD closure (Amplatzer)

15 51 F N N Paroxysmal N/A N/A 2 Surgical Dacron patch ASD repair

*Atrial balloon septoplasty (ABS) was required in patient 3 due to severe lipomatous infiltration of the interatrial septum to dilate the septum to allow passage of the cry-oballoon sheath. †ABS was required in patient 8 due to presence of a severely aneurysmal septum that extended to the left pulmonary vein ostia after tenting with thetransseptal sheath apparatus.

AF ¼ atrial fibrillation; ASD ¼ atrial septal defect; CABG ¼ coronary artery bypass grafting; DM ¼ diabetes mellitus; F ¼ female; HTN ¼ hypertension; LA ¼ left atrial; LVEF ¼left ventricular ejection fraction; M ¼ male; MV ¼ mitral valve; N ¼ no; N/A ¼ not available; VSD ¼ ventricular septal defect; Y ¼ yes.

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PROCEDURAL DETAILS AND BAILOUT ABS OUTCOMES.

Procedural details and procedural outcomes are re-ported in Table 2. One patient underwent cryoballoonablation while the remaining 14 underwent radio-frequency ablation. The mean total procedure timewas 241.1 � 114.6 min and the mean total fluoroscopytime was 62.0 � 29.9 min.

The TSPwas assisted by radiofrequency energy in 10(66.7%) patients: in 1 patient standard electrocauteryin the “cut”mode (BovieMedical, Purchase, New York)was applied at 20 to 40 W at the back end of a BRKtransseptal needle whereas in the remaining patients aradiofrequency transseptal needle (NRG Radio-frequency Transseptal Needle) was used to achievepassage of the needle into the LA. ABS was successfulin all cases and allowed for passage of the sheath intothe LA and completion of the ablation procedure. Themean duration to achieve transseptal accesswas 70.6�32.1 min. Of this total duration, 49.5 � 21.8 min werespent with multiple unsuccessful attempts to obtainaccess before ABS using the techniques describedpreviously. The ABS procedure itself took a mean of21.3 � 19.4 min and was performed during the sameprocedure immediately after other strategies fortransseptal access had failed. In all but 1 patient, ABSwas performed over a stiff guidewire (Amplatz SuperStiff) positioned in the left superior PV. In 1 case, ABS

was performed over a stiff pigtail guidewire (Protrack)deployed in the left atrium. A total of 1 to 6 ballooninflations at 4 to 14 atmwere required to allow passageof the sheaths into the LA (Table 2). Two patientsrequired 2 separate ABS (with the same balloon) forboth sheaths to be advanced into the LA. One patientunderwent single TSP followed by ABS with a 6-mmballoon and both sheaths were inserted through thesame access using a retained wire technique. In thepatient undergoing cryoballoon ablation, the 8.5-F SL-1 sheath was able to pass through the TSP site, but thelarger, 12-F FlexCath could not pass through the lipo-matous septum until ABS was performed. In theremaining patients, 1 of the 2 sheaths could be passedinto the LA while the second sheath could not beadvanced and required ABS to pass to the LA. In bothpatients with Amplatzer closure devices, ABS wasperformed in the native septum posterior and inferiorto the devices.ACUTE PROCEDURAL OUTCOMESAND FOLLOW-UP. Therewere no procedural complications. After a median167.0 days (interquartile range: 7.5 to 360.5 days)follow-up, cumulative AF-free survival was 66.7%overall. Follow-up echocardiography was available forreview in 14 (93%) patients and was performed a me-dian of 114 days after ABS (Table 1). In 1 of the 2 patientsin whom ABS was performed through a GORE-TEX soft

TABLE 2 Procedural Details and Follow-Up Imaging for Patients Undergoing ABS During AF Ablation

Patient #AblationType

TotalProcedureTime (min)

TotalFluoro

Time (min)ABS Time

(min)TSP Time(min)

TSP(Requiring ABS) Techniques Attempted Before ABS

ABS BalloonDiameter

Follow-Up EchoAvailable/ASD

Presence

1 RF 296 75.4 9 68 2 (1) � Bovie RF on needle� Amplatz stiff wire to LSPV, RSPV� SL-1 crossed over Amplatz stiff wire in

LSPV/RSPV� ABS required for Agilis

4 mm 571 daysNo ASD

2 RF 450 61.2 9 99 2 (2) � Baylis RF Needle� Protrack pigtail wire� ABS required for both Agilis sheaths

5 mm Small ASD on TTE at 45days which was alsoseen on TEE at 322days

3 Cryoballoon 198 54.4 2 77 1 (1) � Stiff wire in LPVs� SL-1 crossed but FlexCath sheath would

not� ABS required for FlexCath sheath

6 mm N/A (lost to follow-up)

4 RF 396 N/A 19 61 1 (1) � Amplatz Stiff Wire advanced into theLSPV, LIPV, RSPV

� Single transseptal (double-wiretechnique).

� ABS required for Agilis

6 mm 30 daysNo ASD

5 RF 237 24.2 4 46 2 (1) � Amplatz stiff wire in LSPV, RSPV� Toray pigtail wire� ABS required for Agilis only� Retained wire technique for SL-1

5 mm 85 daysNo ASD

6 RF 354 66.1 18 62 2 (1) � Amplatz stiff wire into LSPV, RSPV� SL-1 crossed over Amplatz stiff wire in

LSPV/RSPV� ABS required for SL-1 only

4 mm 79 daysNo ASD

7 RF 396 53.9 4 45 2 (1) � Amplatz stiff wire into LSPV, RSPV� Agilis crossed over Amplatz stiff wire in

LSPV/RSPV� ABS required for SL-1 only

5 mm 112 daysNo ASD

8 RF 232 32.7 7 41 2 (1) � Amplatz stiff wire into LSPV, LIPV, RSPV� Toray pigtail wire� Agilis crossed over Amplatz stiff wire

in LSPV/RSPV� ABS required for SL-1 only

6 mm 46 daysNo ASD

9 RF 117 32.5 21 50 1 (1) � Stiff wire into LSPV, LIPV� Attempt with Preface braided

guiding sheath (Biosense Webster) and8.5-F HeartSpan sheath (Merit) overAmplatz stiff wire

� Attempted dilation with 4-mm balloon

4 mm, 6 mm 98 daysNo ASD

10 RF 266 141.6 70 167 2 (2) � Baylis RF Needle� Stiff wire into LSPV, LIPV� Pre-dilation with 8.5-F SL-0 dilator� Attempted dilation with 7-mm balloon

7 mm, 10 mm 188 daysNo ASD

11 RF 154 84.3 40 31 2 (1) � Baylis RF Needle� Stiff wire into LSPV, LIPV� Progressive dilation with long dilators

of increasing diameter (9-F, 11-F, 14-F)

5 mm 116 daysNo ASD

12 RF 123 51.3 26 68 2 (1) � Baylis RF Needle� Stiff wire into LSPV, LIPV� Progressive dilation with long dilators

of increasing diameter (9-F, 11-F, 14-F)

5 mm 148 daysNo ASD

13 RF 105 41.4 17 33 2 (1) � Baylis RF Needle� Stiff wire into LSPV, LIPV� Progressive dilation with long dilators

of increasing diameter (9-F, 11-F, 14-F)

5 mm 167 daysNo ASD

14 RF 124 58.5 21 54 2 (1) � Baylis RF Needle� Stiff wire into LSPV, LIPV� Progressive dilation with long dilators

of increasing diameter (9-F, 11-F, 14-F)

6 mm 195 daysNo ASD

15 RF 162 90.2 53 84 2 (1) � Baylis RF Needle� Stiff wire into LSPV, LIPV� Attempted septoplasty with 2- and

4-mm balloons

2 mm, 4 mm,5 mm

72 daysNo ASD

Echo ¼ echocardiography; Fluoro ¼ fluoroscopy; LIPV ¼ left inferior pulmonary vein; LSPV ¼ left superior pulmonary vein; RF ¼ radiofrequency; RSPV ¼ right superior pulmonary vein; TSP ¼ transseptalpuncture; TEE ¼ transesophageal echocardiography; TTE ¼ transthoracic echocardiography; other abbreviations as in Table 1.

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tissue patch ASD repair, a positive bubble studyconsistent with ASD was present on follow-up echo-cardiogram 6 weeks post-ablation. This patient un-derwent a repeat AF ablation 18 months following theindex procedure, and a residual ASD was confirmed onICE; the LA access during the repeat procedure couldbe obtained through the residual ASD without need forrepeat TSP or ABS. This patient remained asymptom-atic during follow-up with regard to the ASD. Nointervention was performed for the ASD and the pa-tient was maintained on anticoagulation. In the 13remaining patients with follow-up echocardiograms,no residual ASD was present (Table 2). In addition tothe patient with the persistent ASD, 2 additional pa-tients underwent repeat AF ablation during follow-upand ABS was again required to achieve transseptal ac-cess in both patients.

DISCUSSION

The present study reports on the largest series of AFpatients in whom transseptal access could not beachieved with standard approaches, and requiredbailout ABS to obtain LA access. Prior descriptions ofABS to obtain LA catheterization have been limited tofew single-patient case reports (5–7). The results ofour study document the high efficacy and safetyprofile of ABS. In particular (5–7), ABS was successfuland permitted passage of the transseptal sheath toallow AF ablation in all patients, and there were nocomplications associated with the procedure. Thesefindings support the inclusion of ABS to the electro-physiology procedural armamentarium as a tech-nique to achieve LA access in patients withchallenging transseptal access.

As the number of patients undergoing AF ablationcontinues to increase, a significant number of patientsreferred for ablation may have undergone prior atrialseptal repair surgeries or previous AF ablation at-tempts in which TSP was performed. In these patients,septal scarring may complicate TSP, making it difficultto access the LA. Several tools and strategies to achievetransseptal access have been proposed, including thedelivery of radiofrequency energy from the needle tipand the use of the SafeSept nitinol guidewire (PressureProducts, Santa Barbara, California) (13–18). Althoughthese strategies are effective for allowing successfulpassage of the transseptal needle across the septuminto the LA, in caseswhere the atrial septum is severelyscarred, it may be impossible to pass the larger-diameter outer sheath across. Other strategiesinclude the use of stiff wires advanced into the LSPV orright superior PV or the use of stiff pigtail wires toprovide more support for the dilator and sheath.

We have also previously described the technique ofpre-dilating the septostomy over a stiff wire withprogressively larger diameter (up to 14-F) long dilatorsto facilitate passage of a transseptal sheath in patientsin whom TSP was performed through ASD closure de-vices (19). In the present series, pre-dilation of theseptostomy site with long dilators of progressivelylarger size was attempted without success in 4 cases.

In our experience, it is more difficult to obtaintransseptal access with stiffer sheaths (such as theAgilis) compared with sheaths with lower outer pro-files (e.g., the standard 8.5-F SL sheaths). This islikely due to the presence of a substantial diametermismatch between the dilator profile and the outerdiameter of the Agilis sheath due to the need toaccommodate the steering mechanism within thebody of the sheath. As a result, there is a significantouter diameter “step-up” between the dilator and theAgilis sheath, which makes advancement of thesheath through the interatrial septum over the dilatormore challenging compared with standard non-steerable transseptal sheaths.

We have previously shown that TSP and LA accessfor AF ablation can be safely performed in patientswith prior atrial septal repair or multiple previous TSPattempts (3). In that prior experience, while TSP wasstraightforward in themajority of cases using standardapproaches, “challenging” TSP (requiring stiff wires ornecessitating multiple attempts) were encountered in5% of patients with multiple ($2) prior LA ablationprocedures and 26% patients with prior atrial septalrepair. Of note, TSP failure was reported in 1% in themultiple TSP group and 4% in prior atrial septal repairgroup (3), and ABS was not attempted in any of thosepatients. The present study expands on our priorexperience by showing the high efficacy of ABS toobtain transseptal access when standard approachesfail. Importantly, the described ABS technique hasbeen utilized only as a “bailout” strategy in the raresituation that all other techniques failed to permittransseptal access. Specifically, ABS has only beenrequired for transseptal access in 0.17% of patientsundergoing AF ablation at our 2 centers since we star-ted using the technique. Before the introduction ofABS, there were 5 patients between the 2 study centersin whom transseptal access failed (2 with multipleprior TSPs, and 3 with ASD patch repairs) and LA accesscould not be achieved. Since we began using the ABStechnique, there have been no patients at either centerin whom transseptal access could not be achieved.Upon transseptal access following ABS, we could notdetect any qualitative difference in catheter maneu-verability or torqueability within the LA comparedversus standard cases.

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Themain concern with the use of ABS is the creationof persistent ASD. To minimize the occurrence of thiscomplication, careful attention was paid to size theballoon appropriately (i.e., slightly larger than thetransseptal sheath outer diameter) and in some cases,only low-pressure partial balloon inflation wasrequired to dilate the septum enough to allow passageof the transseptal sheaths. As such, the size of the ASDcreated with our ABS technique should be comparableto what is routinely created with standard transseptalsheaths. The occurrence of persistent ASD followingtransseptal access with large sheaths in patients un-dergoing catheter ablation for AF is well known. Forexample, in 1 study, 22% of patients treated with cry-oballoon ablation with a 15-F transseptal sheath hadpersistent ASD compared with 8.5% of those treatedwith double transseptal access using two 8-F sheathswith radiofrequency catheter ablation after 11.6months’ follow-up (20). In another series of 42 patientsundergoing TSP for AF ablation, Hammerstingl et al.(21) reported that the risk of persistent ASD is higher inpatients treated with a single TSP through which anablation catheter plus an 8-F sheath are advanced intothe LA (8 of 27 [29.6%] developed ASD) as opposed to 2separate transseptal sheaths (0 of 15 [0%]). Typically,when iatrogenic ASDs occur post-TSP, they frequentlywill resolve spontaneously over time. Rillig et al. (22)examined rates of ASD after AF ablation via a singlepuncture, double-transseptal approach with remoterobotic navigation system using both an 8.5-F SL-0 sheath and a 14-F sheath for the robotic catheter.Of the 40 total patients in their series, ASD wasdetected in 95% on day 1 post-ablation, 48% at 3months, and 20% at 6 months. They found that of the38 patients with an ASD on day 1, 30 (79%) had closedspontaneously by 6 months. Singh et al. (23) showedsimilar results in a subset of 253 patients from thePROTECT-AF (Percutaneous closure of the left atrialappendage versus warfarin therapy for prevention ofstroke in patients with atrial fibrillation) study inwhom a 12-F transseptal sheath was used to deploy LAappendage occlusion devices. In their study, ASD wasseen in 87% immediately post-procedure, 34% at 45days, 11% at 6 months, and only 7% at 1 year.

In our study, 14(93%) patients underwent a follow-up echocardiographic study to assess for residualASD, which was seen in just 1 (7%) patient. Of note,we found no evidence of residual ASD in all patientsin which ABS had been performed through the nativeseptum or prior pericardial patch repair, which isconsistent with the observations of prior studies (6,7).However, a persistent ASD was detected in 1 of the 2patients in whom ABS had been performed through aGORE-TEX patch.

Although no definite conclusions can bemade basedon the small sample size of our study, it is possible thatthe likelihood of persistent interatrial shunt afterseptoplasty may differ when ABS is performed in thenative septum versus prosthetic patches. Although thenative atrial septum may be capable of healing afterABS resulting in spontaneous closure, ABS through asynthetic patchmay be less likely to heal and thusmorelikely to result in permanent ASD.

STUDY LIMITATIONS. This was a retrospective studywith a small sample size and a short mean follow-upduration. As per our standard of care for AF ablation,residual ASD was qualitatively assessed with colorDoppler at ICE immediately post-procedure and it didnot appear to be bigger than what is usually observedfor standard AF cases where ABS is not used. Thisfinding is likely due to a careful choice of balloon di-ameters comparable to the outer diameters of standardtransseptal sheaths. However, a formal measurementof the size of the residual ASD as visualized by post-procedure ICE was not performed, and this is apotential limitation. Post-procedure follow-upechocardiography was done with transthoracicechocardiography and we do not routinely performtransesophageal echocardiography to assess forpersistent ASD in asymptomatic patients after ABS.Weacknowledge that transthoracic echocardiographymay be less sensitive to detect ASD than trans-esophageal echocardiography. One patient transi-tioned their care elsewhere after their procedure andwe were unable to contact this patient for repeat im-aging. As such, we are unable to confirm the trueincidence of iatrogenic ASD after ABS. Finally, pre-dilation of the septostomy with dilators of increasingsize was attempted only in 4 patients because larger-diameter long dilators were not readily available inthe electrophysiology lab for the remaining cases. Assuch, it is possible that pre-dilation with larger-diameters dilators might have been successful insome of the cases that required ABS in this study.

CONCLUSIONS

In AF patients with scarred or thickened LA septumundergoing catheter ablation, bailout ABS can besafely performed and is an effective adjunctivestrategy to obtain transseptal access.

ADDRESS FOR CORRESPONDENCE: Dr. PasqualeSantangeli, Division of Cardiology, ElectrophysiologySection, Hospital of the University of Pennsylvania, 9Founders Pavilion–Cardiology, 3400 Spruce Street,Philadelphia, Pennsylvania 19104. E-mail: pasquale.santangeli@uphs.upenn.edu.

PERSPECTIVES

COMPETENCY IN MEDICAL KNOWLEDGE: In

patients with scarred, surgical, or percutaneously repaired

atrial septum, TSP and LA access can be difficult. ABS is a

safe and effective bailout strategy to facilitate passage of

the transseptal sheath into the LA after other strategies

had failed.

TRANSLATIONAL OUTLOOK: Larger series are

necessary to confirm the safety and efficacy of ABS

before it can be used as mainstream strategy to facilitate

transseptal access. Studies with longer follow-up dura-

tion and serial echocardiograms are necessary to deter-

mine the true incidence and significance of persistent ASD

after ABS.

J A C C : C L I N I C A L E L E C T R O P H Y S I O L O G Y V O L . - , N O . - , 2 0 1 8 Liang et al.- 2 0 1 8 :- –- Balloon Septoplasty for Transseptal Access

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KEY WORDS angioplasty, atrial fibrillation,balloon, catheter ablation, septoplasty,septostomy, transseptal

APPENDIX For a supplemental video,please see the online version of this paper.