Europace (2011) 13, 1401–1405 CLINICAL RESEARCH

doi:10.1093/europace/eur155 Ablation for Atrial Fibrillation

The use of a novel nitinol guidewire to facilitate

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transseptal puncture and left atrial
catheterization for catheter ablation procedures
Vineet Wadehra 1, Alfred E. Buxton 2, Antonios P. Antoniadis 1, James W. McCready 1,
Calum J. Redpath 1, Oliver R. Segal 1, Edward Rowland 1, Martin D. Lowe 1,
Pier D. Lambiase 1, and Anthony W.C. Chow 1*
1
The Heart Hospital, University College London Hospitals NHS Foundation Trust, 16 –18 Westmoreland Street, London W1G 8PH, UK; and 2Brown University,
Providence, RI, USA

Received 16 January 2011; accepted after revision 21 April 2011; online publish-ahead-of-print 8 August 2011

Aims An increasing number of transseptal punctures (TSPs) are performed worldwide for atrial ablations. Transseptal
punctures can be complex and can be associated with potentially life threatening complications. The purpose of
the study was to evaluate the safety and efficacy of a novel transseptal guidewire (TSGW) designed to facilitate TSPs.
.....................................................................................................................................................................................
Methods Transseptal punctures were performed using a SafeSeptTM TSGW passed through a standard TSP apparatus. Trans-
and results septal punctures were performed by standard technique with additional use of a TSGW allowing probing of the
interatrial septum without needle exposure and penetration of the fossa into the left atrium (LA). Transseptal punc-
ture using the TSGW was performed in 210 patients. Left atrial access was achieved successfully in 205 of 210
patients (97.6%) and in 96.3% of patients undergoing repeat TSP. Left atrial access was achieved with the first
pass in 81.2% (mean 1.4 + 0.9 passes, range 1–6) using the TSGW. No serious complications were attributable
to the use of the TSGW, even in cases of failed TSP.
.....................................................................................................................................................................................
Conclusions The TSGW is associated with a high success rate for TSP and may be a useful alternative to transoesophageal or
intracardiac echocardiogram-guided TSP.
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Keywords Atrial fibrillation † Ablation † Transseptal puncture † Left atrial catheterization

Complications are reported to occur in up to 6% of patients

Introduction undergoing TSP.2,4 These include potentially life-threatening com-
Percutaneous transseptal puncture (TSP) was first performed in plications such as cardiac and aortic root perforations, tamponade,
the 1950s to allow direct access to the left cardiac chambers by and arterial thrombo-embolism. Complications predominantly
making a passage through the fossa ovalis from the right atrium.1 arise as a result of the relatively small target area for puncture
The procedure was developed to perform haemodynamic on the interatrial septum that can be ,0.5 cm2 and the marked
studies of the left heart and subsequently modified for percuta- anatomical variations between patients. Various strategies have
neous balloon mitral valvotomy. In recent years, most TSPs are been implemented to improve the safety of the procedure, includ-
performed by electrophysiologists for catheter ablation of atrial ing land-marking key anatomical positions with diagnostic electro-
fibrillation (AF).2 The increasing success and expansion of catheter physiology catheters5 and right atrial angiography, particularly in
ablation therapy for AF has resulted in an increasing number of patients suspected of having unusual anatomy.6 In addition to con-
TSPs performed worldwide.3 This will inevitably lead to TSPs ventional fluoroscopy, imaging modalities such as transoesophageal
being performed in lower volume centres with cases of varying echocardiography (TEE) or intracardiac echocardiography (ICE)
complexity. provide direct visual guidance during TSP to improve safety.7,8

* Corresponding author. Tel: +44 20 75738861; fax: +44 20 75738847, Email: anthonychow@uclh.nhs.uk
Published on behalf of the European Society of Cardiology. All rights reserved. & The Author 2011. For permissions please email: journals.permissions@oup.com.
1402 V. Wadehra et al.

However, many centres do not have the expertise nor imaging the LA. If the wire is pushed in an incorrect position outside the
tools available that require additional resources and cost. fossa ovalis, crumpling and resistance is encountered, and an attempt
Significant proportions of AF patients, especially those with per- using a different orientation is required, thus acting as a probing
sistent AF, require more than one ablation procedure and conse- wire. If passage through the septum into the LA is achieved, the guide-
wire passes effortlessly without resistance in its pre-formed ‘J’ shape
quently multiple TSPs may be required.9 It is also recognized
through the left atrial chamber, usually into the left superior pulmonary

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that repeat TSP is associated with higher risk of adverse events
vein (Figure 1A). The radio-opaque platinum proximal shaft of the
and increased failure rates.10 – 12
guidewire provides fluoroscopic confirmation of the position of the
We describe our initial experience of using a novel transseptal TSGW. The stiffer proximal portion of the TSGW provides tracking
guidewire (TSGW) to aid TSP. This wire has been designed to and additional support for the passage of the rest of the TSP apparatus.
improve TSP success rates, with particular focus on improving The needle and then the dilator and sheath are then passed into the LA
safety, especially in previously failed or difficult cases. using an over-the-wire technique (Figure 1B). If penetration fails with
the TSGW, further attempts in a different orientation are then
needed and may require a further pass of the transseptal apparatus
Methods from the superior vena cava. For double transseptal access, the
second TSP is performed in a similar manner using the same TSGW
From June 2008 to May 2010, TSPs using a custom-designed TSGW
and Brockenbrough needle with a second transseptal sheath. Following
(SafeSeptTM , Pressure Products Inc., San Pedro, CA, USA) were evalu-
successful transseptal access to the LA, a bolus of intravenous weight-
ated at The Heart Hospital, University College Hospital NHS Foun-
adjusted heparin (100 IU/kg) is administered and doses given later to
dation Trust, London, UK and at Brown University, Providence, RI,
keep the activated clotting times above 300 s throughout the
USA.
procedure.

Transseptal puncture using transseptal

guidewire Results
In patients undergoing AF ablation, TEE was performed to exclude the
presence of left atrial thrombus and to look for patent foramina ovale.
Between June 2008 and May 2010, TSP using the SafeSeptTM
If the septum was intact, TSP was performed with the TSGW and stan- TSGW was evaluated in 210 consecutive unselected patients.
dard transseptal equipment using a modified Brockenbrough approach Baseline characteristics of the study population are summarized
described below. in Table 1. The majority of cases were performed for AF/atrial
tachycardia ablation. Left atrial diameter was enlarged at 43 +
Transseptal guidewire 7 mm. Successful LA access using the TSGW was achieved in
The TSGW is a 0.014 inch nitinol wire with a sharp distal tip and 205 patients (97.6%). One hundred and thirty patients (61.9%)
preformed ‘J’ shape. This was introduced through the inner lumen underwent TSP for the first time and 80 patients (38.1%) had pre-
of a standard Brockenbrough transseptal needle to penetrate the viously undergone TSP. There was no difference in the success
interatrial septum into the left atrium (LA). The guidewire is then rates between these groups (Table 2). Left atrial access was
advanced straightened, through the standard transseptal needle
achieved with the first pass in 81.2% (mean 1.4 + 0.9 passes,
using an introducer. The outer needle and sheath giving the
range 1–6) using the TSGW. In successful cases, the mean
sharpened tip direction and a column support required to cross
the septum. On crossing the septum, the wire immediately
returns to its preformed ‘J’ shape. This design feature renders the
tip atraumatic, reducing the risk of potential injury or perforation
of the LA.

Transseptal puncture technique

A quadripolar or decapolar catheter was inserted into the coronary
sinus via a femoral sheath. A standard transseptal sheath (Agilis
NXT/SL0/SL1, St Jude Medical Inc., St Paul, MN, USA; Channel
sheath, Bard electrophysiology, Lowell, MA, USA) was advanced to
the superior vena cava from the femoral vein using an over-the-wire
technique and a Brockenbrough transseptal needle (BRK or BRK1, St
Jude Medical Inc., St Paul, MN, USA) introduced and advanced to
just proximal to the sheath tip. The sheath and un-exposed needle
were slowly pulled down from the superior vena cava with the Figure 1 (A) This is a fluoroscopic image showing the transsep-
sheath and needle in a 4 – 6 o’clock orientation in the left anterior tal sheath positioned on the fossa ovalis in a 308 left anterior
oblique projection under fluoroscopic guidance until the sheath oblique position without advancing the needle. The SafeSeptTM
dropped into the fossa ovalis. A TSGW (SafeSeptTM , Pressure Pro- wire is seen penetrating the interatrial septum and the TSGW
ducts Inc., San Pedro, CA, USA) was then inserted into the Brocken- is then passed into the left superior pulmonary vein. (B) The
brough needle and advanced to the unexposed tip. The position of dilator portion of the sheath is then advanced over the TSGW,
the sheath assembly was examined in the right anterior oblique projec- later followed by the outer transseptal sheath. S represents the
tion to ensure it lies centrally on the interatrial septum posterior to the TSGW (SafeSeptTM ), T the transseptal sheath, and C the quadra-
coronary sinus catheter and anterior to the posterior heart border. polar coronary sinus catheter used for land-marking.
The TSGW was then advanced onto the septum and through into
Novel guidewire to facilitate transseptal puncture 1403

number of passes required to achieve LA access was 1.4 + 0.9 for Transseptal puncture using direct TEE guidance under general
patients undergoing TSP for the first time and 1.3 + 0.8 for those anaesthesia was used in 45 patients (21.4%), either because of
having previously undergone TSP. patient preference or if a previous TSP attempt had been unsuc-
cessful or had resulted in complication. The remaining procedures
were performed under local anaesthetic and conscious sedation.

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Table 1 Baseline characteristics of the study Contrast and pressure monitoring were used for the initial five
population patients, it was deemed unhelpful and unnecessary due to
damped pressure waveforms and poor opacification following con-
Age (years)
trast injection, due to the presence of the wire partially obstructing
Mean 60.2 + 11.9
the needle lumen. Trainees performing TSP under direct supervi-
Range 19.4– 84
sion were primary operators in 48% of cases and senior operators
Sex (male : female), n (%) 142 (67.6%) : 68 (32.4%)
performed TSP in the remainder of the cases.
Mean left atrial diameter (mm) 43 + 7
Indications for TSP, n (%)
Complex transseptal puncture patients
Paroxysmal AF 86 (41.0%)
Persistent AF 78 (37.1%)
Nineteen patients with a previous history of difficult TSP had suc-
Left atrial tachycardia/flutter 27 (12.9%)
cessful LA access using the standard techniques with the TSGW.
Accessory pathway 15 (7.1%)
This included nine patients with previously failed conventional
Ventricular tachycardia 4 (1.9%)
TSP, including two patients with TEE guidance under general
anaesthesia. The TSGW was also used in a further 13 patients in
AF, atrial fibrillation; TSP, transseptal puncture. whom conventional TSP had been unsuccessful but LA access
was successfully achieved by the same procedure with introduction
of the TSGW. Left atrial access was obtained using the TSGW with
the first pass in 10 (76.9%) of these cases.

Table 2 Left atrial access using transseptal guidewire Unsuccessful transseptal puncture with
Patients Patients with the transseptal guidewire
without previous In four patients without obvious complex anatomy undergoing
previous history history of TSP TSP, LA access was unsuccessful using the TSGW (Table 3). Of
of TSP
................................................................................ these, the first patient had undergone four previous TSPs during
Number of patients, n 130 80 two ablation procedures for persistent AF. Following three failed
Successful LA access 98.4 96.3 passes with the TSGW, the procedure was converted to conven-
obtained with TSGW (%) tional TSP, which was also unsuccessful. The second patient had no
First pass success with 82.2 79.7 prior TSP. In this case, the TSGW crumpled on the septum on the
TSGW (%) second pass and subsequent contrast injection suggested pericar-
Number of passes with 1.4 + 0.9 1.3 + 0.8 dial staining. On review, the orientation of the sheath was felt to
TSGW required for LA
be too anterior on the septum before the TSGW was advanced.
access (mean + standard
deviation) The third patient had undergone four prior TSPs during two abla-
tion procedures for paroxysmal AF and LA tachycardia. Despite
LA, left atrium; TSGW, transseptal guidewire; TSP, transseptal puncture. apparent correct fluoroscopic positioning on the septum, the
TSGW failed to cross the fossa ovalis in spite of two separate

Table 3 Unsuccessful transseptal puncture using transseptal guidewire

Patient Arrhythmia LA size Previous Description

demographic (mm) TSP
...............................................................................................................................................................................
65-year-old man Paroxysmal AF 44 4 TSGW failed despite three passes followed by unsuccessful TSP using a conventional
approach with the Brockenbrough needle
42-year-old man Paroxysmal AF 48 0 TSGW crumpled on the initial attempt. Appeared to cross the septum on the second
attempt. Pericardial staining was seen. The procedure was abandoned
66-year-old woman Persistent AF 62 4 TSGW failed despite three passes of the sheath followed by a further attempt with a
conventional approach resulting in aortic puncture
67-year-old woman Paroxysmal AF N/A 1 One attempt with the Brockenbrough needle was unsuccessful. TSGW was also
unsuccessful. Further attempt with the Brockenbrough needle was unsuccessful

AF, atrial fibrillation; LA, left atrium; TSGW, transseptal guidewire; TSP, transseptal puncture.
1404 V. Wadehra et al.

attempts. Subsequent conversion to conventional TSP by the were two patients in whom a previous conventional approach
operator without TSGW resulted in aortic puncture, with no peri- under direct TEE guidance failed to provide LA access due to
cardial or haemodynamic sequelae on serial echocardiography. All resistance encountered at the septum, but LA access was success-
three cases were abandoned, without need for pericardial drainage fully achieved using the TSGW. Patients with previous history of
or surgical intervention. All three patients subsequently underwent TSP are more likely to have thickened or fibrotic septa due to scar-

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successful TSP using TSGW under TEE guidance. The fourth ring,10 but this may not always be evident or predictable from TEE.
patient had unsuccessful TSP using a conventional approach In this study, the TSGW was successfully used without compli-
without the TSGW followed by unsuccessful attempts using the cation in 13 patients in whom a conventional approach failed and
TSGW. Left atrial access was obtained at the same sitting with a in 19 patients with a previous history of difficult or failed TSP.
further conventional approach after sheath and needle reposition- The design of the TSGW with a sharp nitinol tip provides a signifi-
ing. Intracardiac echo guidance was used throughout the case. cantly higher pressure per unit area than a conventional transseptal
These procedures were performed by operators experienced at needle. The profile of the tip allows greater penetration through
TSP but with limited experience of using the TSGW. All the the septum and the immediate formation of a ‘J’ shape prevents
failed cases occurred within the first 10 procedures for each injury or trauma to neighbouring cardiac structures once it suc-
operator. cessfully crosses into the LA. Once the tract has been made, the
A further two patients required the unplanned use of TEE gui- wire provides a safe over-the-wire approach to advancing the
dance after failure to obtain LA access despite multiple attempts needle tip and sheath into the LA, proving to be particularly effec-
using the TSGW. Transoesophageal echocardiography suggested tive for fibrous and aneurysmal septa. In all cases of successful LA
incorrect positioning of the TSP sheath and TSGW due to unu- penetration by the TSGW, the remaining TSP apparatus could be
sually distorted and rotated anatomy not appreciated on fluoro- advanced without problems.
scopy, and subsequent imaging-guided TSP using the TSGW was The use of a small-calibre TSGW allows the operator to probe
successful in both cases. We did not observe any incidence of the interatrial septum with a degree of safety to find a passage into
aortic root puncture with the TSGW and no complications attribu- the LA, rather than probing with a larger-calibre transseptal needle.
table to the use of the TSGW were observed during the evaluation When the TSGW is not correctly positioned against the thin mem-
period. branous portion of the fossa ovalis, it deforms by crumpling or is
Finally, the TSGW failed in a complex patient with atrial tachy- deflected along the septal wall. When this occurs it suggests that
cardia with Mustard circulation for transposition of the great the TSP apparatus is in the wrong position or orientation that
arteries and ventricular septal defect having undergone a ventricu- may occur due to unexpected or atypical anatomy. This requires
lar septal defect repair and systemic atrioventricular valve replace- either a further attempt in a different orientation or the need
ment with a mechanical prosthesis. This was done under general for direct imaging. This was observed in the patients in whom
anaesthesia, but both conventional and TSGW attempts under the TSGW failed to facilitate LA access. Two of these patients
TEE guidance were unsuccessful. had successful TSP using the TSGW when TEE was utilized at
the same sitting. Review of the unsuccessful cases using the
TSGW suggests that, in all of these patients, TSP failure was due
Discussion to incorrect positioning of the transseptal apparatus on the intera-
This is the largest series hitherto evaluating a novel TSGW trial septum rather than a failure of the TSGW per se. Despite this,
(SafeSeptTM ) designed to facilitate safe TSP for LA access. In a no serious complication occurred as a result of its use. We suggest
recent report of 27 clinical cases TSGW was applied with absolute that unsuccessful TSP using a TSGW occurs because of anatomical
safety and efficacy.13 Our experience in 210 patients indicates that variability and potentially incorrect positioning of the TSP appar-
TSP performed using the TSGW appears safe, is associated with a atus on the septum. Our experience suggests a change of strategy
high procedural success rate, and is useful in difficult cases with a is often required at this point and that a direct imaging-guided
previously failed conventional approach. No complications directly approach may be safer in these instances rather than resorting
attributable to the use of the TSGW were observed during the to pushing with the TSP needle alone where complications may
evaluation period. The five cases that failed using the TSGW occur.
were a result of complex anatomy and may not have been achieved A major limitation of this study is that it is not a randomized
conventionally without direct imaging. control study comparing the TSGW and standard conventional
Transseptal puncture is successfully achieved in the majority of TSP techniques, but important safety and feasibility data are gath-
patients. However, up to 10% of cases can be complex and may ered to test the efficacy of this new technology by experienced
either fail to cross into the LA or are associated with serious com- operators and trainees in a significant and meaningful numbers of
plications.2 A substantial number of centres still perform AF abla- patients.
tion under local anaesthesia and sedation, guided entirely by
fluoroscopy and pressure monitoring. This approach may not
reliably predict the safe zone for TSP or the level of difficulty Comparison with other technologies to
that may be encountered in all cases. Direct echo guidance assist transseptal puncture
remains the gold standard for safety by providing visual guidance Other technologies used for difficult TSP have been described,
to TSP and would be invaluable for patients with rotated or including a specially designed radiofrequency needle and generator
unusual anatomy.8,14,15 However, even within this study, there to facilitate passage into LA16 and direct application of
Novel guidewire to facilitate transseptal puncture 1405

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