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Novel solutions applied in
transseptal puncture
technique: a systematic
review of current literature
Bibliographic Survey
Pedro André Gonçalves Morais, UP201400020
Doctoral Program in Biomedical Engineering
2014/2015
Title: Novel solutions applied in transseptal puncture technique: a systematic review of
current literature
Abstract
Background: Access to the left atrium is required for several minimally invasive cardiac
interventions of the left heart. Hereto, transseptal puncture (TSP) technique was proposed,
which relies on the perforation of atrial septum through a catheter inserted in the right atrium
(RA) via the venous system under fluoroscopic guidance. Although this approach has been
used for many years, complications and procedural failures are common.
Purpose: Recently, a high number of authors proposed novel solutions to overcome the mainlimitations of TSP technique, increasing consequently the safety and feasibility of the
procedure. This study presents an overview of these novel methods, indicating their
advantages throughout the puncture procedure.
Material and Methods: A systematic review of literature was conducted through the analysis
of the articles published between 2008 and 2015. The search was performed in PubMed,
Scopus and ISI Web of Knowledge using the expression “transseptal puncture”. A total of 834
results were retrieved from database, and 192 results were selected for this review. Moreover,
these 192 results were divided into four categories, namely: 1) incidence studies; 2) intraprocedural guidance techniques; 3) pre-procedural planning methods and 4) surgical
instruments.
Results: A total of 37 articles focused on incidence studies, presenting the number of TSP
interventions, puncture attempts, complications and failure rate. 24 articles suggested novel
intra-procedural guidance techniques. Pre-procedural planning strategies were proposed in a
total of 5 works. Regarding the surgical instruments, a total of 21 works were selected.
Conclusion: The novel 3D guidance techniques, surgical instruments and pre-intervention
planning approaches showed potential to overcome the main procedural
limitations/complications, through the reduction of the intervention time, radiation, number
of failures and complications.
Keywords: transseptal puncture, left atrium access, systematic review, optimal puncture
position
1
1. Introduction
Percutaneous access of the left atrium (LA) is required in a large number of minimally
invasive procedures, such as catheter ablation for atrial fibrillation, paravalvular leakage repair,
percutaneous mitral valve replacement, pulmonary vein isolation and left atrial appendage
closure [1, 2]. These procedures show a high application rate (see Table 1) being a preferred
technique to the traditional open-chest surgery, due to the lower costs and lower complication
rate. However, the procedures are not free of risks being dependent of physician experience
and medical devices used (e.g. image acquisition or surgical equipment) [3]
Direct access to the LA is not physical possible, making these transcatheter procedures
cumbersome. Two techniques are commonly used to perform this task: transaortic (TA) access
and transseptal puncture (TSP). In TA access, a catheter inserted in the femoral artery is
retrogradely advanced through the aortic valve towards the left ventricle (LV). Subsequently,
the catheter is rotated 180° and advanced throughout the mitral valve (MV) into the LA
chamber. Regarding the TSP, a catheter is inserted into the right-atrium (RA) via the venous
system, through which a needle can be moved forward, in order to puncture the interatrial
septum (IAS) and consequently access the LA. Thus, TSP technique establishes a “more direct”
access route, when compared with TA approach. Nonetheless, in complex situations TSP
technique can perforate a large vessel (e.g. aorta) resulting in serious complications for the
patient.
Despite the similar performance and safety between the two techniques [3, 4], TA route
requires a 180° rotation of the catheter, complicating its manipulation and consequently
hampering the procedure. Moreover, the TA strategy uses an access route through the highpressure arterial system. Contrarily, TSP enters into the LA using the low-pressure venous
system. As such, in the last years a superior number of procedures based on TSP were
registered [3].
Furthermore, new strategies have been proposed to overcome the main-complications of
the TSP, through the inclusion of novel guidance, planning methods and surgical instruments
on the traditional procedure. In the current study we intend to present an overview of the new
strategies and summarize their advantages. Moreover, this study also presents a review of
clinical studies that reported incidence of TSP procedure.
As a summary, the current work introduces four novelties, namely: 1) an incidence study
about TSP approach; 2) a review of the recent guidance methods applied in TSP procedure; 3)
a review of recent intra-procedural planning methods for safe puncture zone recognition; and
4) an overview of novel surgical instruments recently used to puncture the IAS wall.
As a final remark, the current article is divided on six-main sections: 1) considerations
about atrial anatomy; 2) description of the traditional TSP method; 3) method used to identify
the relevant studies for this review; 4) aims and main-conclusion of the selected articles; 5)
discussion of the relevant articles, presenting their advantages and main drawbacks; and 6)
conclusions of the proposed review.
2
Table 1 – Application rate of different percutaneous procedures that require TSP technique.
Procedure
Application rate
Catheter ablation for
atrial fibrillation
In 2010, 8.8 million of patients had atrial fibrillation in the Europe Union. A
projection study estimated a total of 17.9 million of patients at 2060 [5].
Paravalvular leakage
repair
Affects 5%-17% of all implanted prosthetic heart valves [6].
Percutaneous mitral
valve replacement
Mitral valve diseases present an estimated prevalence of 7% in subjects
≥75 years old [7].
2. Atrial anatomy
Transseptal access of the LA requires large knowledge and experience of the atria
anatomy, particularly the IAS wall. Moreover, the physician should be aware of possible
anatomic variations to correct and safe recognition of the optimal puncture position [8]. As
such, in this section an overview of the atria anatomy and possible variations is presented.
The RA shows larger volume and thinner walls (approximately 2 mm) than LA.
Anatomically, the superior RA is composed by the superior vena cava (SVC) and the right atrial
appendage [9]. The inferior RA is constituted by the inferior vena cava (IVC) and the tricuspid
valve. The SVC receives the blood from the superior part of the body, while the IVC returns the
blood from the inferior one. The tricuspid valve controls the blood circulation between the RA
and the right ventricle (RV). Furthermore, particular attention with the coronary sinus (CS)
position is required. The CS is a set of vessels that collect blood from the myocardium draining
into the RA. This structure is positioned between the orifice of the IVC and the tricuspid valve
[9, 10].
On the other hand, the LA is smaller with thicker walls (approximately 3 mm). It presents a
cuboidal shape, being limited superiorly by four pulmonary veins and the left atrial appendage
(LAA) [9]. Inferiorly, the mitral valve (MV) controls the blood circulation between the left atria
and left ventricle [10]. As a final remark, it should be noticed that: 1) the aorta and pulmonary
artery cover the LA externally [11]; and 2) the LA is separated from the esophagus by a thin
fibrous pericardium [11].
The interatrial septal wall (IAS) is found between the two atria. The IAS is formed from the
fusion of the septum primum (LA septum) and the septum secundum (RA septum) [1]. The
fusion region is termed limbus (or “true septum”) presenting a larger thickness. However, a
depression can be detected in the middle of the limbus, which is called fossa ovalis (FO) [9].
The FO is the thinnest region of the IAS and it is composed by thin fibrous tissue [9].
Additionally, it has an oval or circular shape and can only be detected from the RA [1].
Anatomically, the FO presents an expected average area between 1.5-2.4 cm2 and it is situated
at the lower part of the septum, between the IVC and the CS [1]. Since lowest thickness is
found at the FO, transseptal access of the LA is traditionally performed through this structure.
[12]. Beyond the FO, the His bundle can be also detected at the inferior IAS wall and it is
composed by myocardial cells that propagate the electric pulse from the atrioventricular node
to the ventricles [9].
In Table 2 is presented an overview of the most common anatomic variations of the atria
region. Note that different LA access site is required when an abnormal anatomy is identified.
3
Table 2 – Overview of the main anatomic variations of the atria.
Anatomic
variations
Description
Difficulties
Solution
Patent
foramen
ovale (PFO)
- Direct route between
the RA and the LA
(prevalence of 27% of the
population) [13].
- LA access without any
puncture [13].
Since the PFO is located at the
anterior and superior part of
the IAS, access to the
pulmonary
veins
are
hampered [13, 14].
TSP procedure
should be used,
even in the
presence of PFO
[14].
Left atrium
dilation
- LA dilation results in a
Different TSP
Higher risk of puncture an
posterior position of the
position should
adjacent structure [8].
FO [8].
be used [8].
Abnormal
mechanical
properties
of the IAS
- Heart diseases can
result in aneurysmal,
elastic or thickened IAS
wall [15].
- Patients with previous
TSP procedure, present a
thickened IAS wall [16].
Abnormal
position of
the FO
Superior LA access reduces the
Puncture
the
- Superior position of the maneuverability of catheters in
inferior part of
FO is detected [11].
pulmonary veins and mitral
the FO [11].
valve procedures [11].
TSP procedure can result in
serious complications for the
patient, such as, atrial roof
puncture or aortic route
puncture. Furthermore, TSP
procedure can fail [15].
Application of
radio-frequency
(RF)
needles
[15].
These modifications are crucial to ensure the maximum safety of the procedure and reduce
the number of complications [14].
3. Traditional transseptal puncture technique
In the current section, a briefly description of the TSP procedure is presented. Moreover,
an overview of the common procedural complications is stated.
The TSP procedure has been widely explained in literature [1, 3, 17], reporting the
guidance equipment and catheters used to safely puncture the IAS wall. The technique is
guided using bi-dimensional fluoroscopy and is performed using a mechanical Brockenbrough
needle (BRK, St. Jude Medical, Minneapolis, MN, USA). Furthermore, several auxiliary
catheters are used to prevent puncture of vital structures. For instance, catheters at the aorta,
CS and His bundle are commonly used. Regarding the procedural time, frequently 1 to 15
minutes are required to perform this task. [15, 16, 18-20].
The procedure starts with the insertion of a guidewire (0.032-0.035 inch) into the IVC
using the right femoral vein access. This step is guided using a anterioposterior fluoroscopy
view. The guidewire is used to define a safe route between the femoral vein and the SVC. A
dilator and sheath are also positioned into the SVC using the guidewire. At this stage, the
guidewire is replaced by the BRK needle, maintaining it inside the sheath to prevent
inadvertent punctures. Then, the assembly (needle, sheath and dilator) is positioned at the FO
region. The assembly is rotated to 4-5 o’clock position and posteriorly pulled-down using a left
anterior oblique (LAO) fluoroscopy view. At this point, two movements will be detected: the
first indicates the entrance of the assembly into the RA; and the second, which is less
perceptible, occurs when the assembly is inside the FO region. A confirmation of the assembly
4
position is achieved using the right anterior oblique (RAO) direction of the fluoroscopic tube.
Since puncture outside the FO increases the risk of perforating vital structures and limits the
maneuverability of the catheter in the LA, confirmation of the needle position should be
performed [11]. Furthermore, a confirmation of the actual position of the aorta, CS and His
bundle is required to ensure safety of the puncture.
Finally, the puncture can be performed and the surgical tool can be introduced into the
LA. The position of the needle is confirmed using the left atria pressure variation or contrast
agents to confirm the needle position. It should be noted that a repetition of the entire
procedure is required when the assembly is not aligned with the FO or when the expert has
doubts about the assembly position.
As a final remark, although low complication and failure rate (approximately 1% of the
procedures [3]) are commonly associated with the TSP, the physician should be aware of:
aortic root puncture, arterial air embolism, pericardial tamponade, right or left atrial wall
puncture, transient ST-segment elevation, pleuritic chest pain, persistence of atrial septal
defect and death as all are complications that can be caused by this intervention [3, 16, 19, 2125]. Furthermore, since TSP creates a hole in the IAS, post-procedural complications are
reported, such as persistent iatrogenic atrial septal defects (iASD). iASD can originate serious
complications (e.g. mitral valve calcification, lower cardiac output, increased rate of
paradoxical embolism), consequently requiring a second procedure [26-30].
4. Materials and Methods
In this section, we report the criteria used to identify the relevant works for this review.
4.1. Selection Method
A search was performed on PubMed, Scopus and ISI Web of Sciences databases between
9 of April of 2015 and 10 of April of 2015. The search used the expression “transseptal
puncture”. Note that only works published between January of 2008 and April of 2015 were
considered. As a result, a total of 834 articles were obtained and, posteriorly evaluated.
Figure 1 - Transseptal puncture traditional technique. (a) A catheter (blue) is placed into the SVC; the catheter is
pull-down and two movements are detected, namely: (b) entrance into the RA and (c) entrance into FO; (d) after FO
identification the puncture is performed.
5
4.2. Data Collection and Processing
In all 834 articles, we analyze the title and the abstract. In this step, the follow criteria
were established, namely: 1) the study must be written in English; 2) patents were excluded; 3)
studies with main focus different of the proposed study were excluded. Furthermore, letters
reviews and clinical reports of one difficult procedure were also not used. Table 3 presents an
overview of the excluded reviews. As such, a total of 64 articles were selected for the current
review. As a final remark, Figure 3 presents an overview of the number of studies per year and
the number of selected papers in each of the three databases used.
4.3. Data Analysis
The 65 selected articles (192 results) were completely analyzed and classified into
different categories: incidence studies, intra-procedural guidance techniques, pre-procedural
planning methods and surgical instruments (see Figure 2). A work can be included in more
than one category.
5. Results
In this section an overview of the main topic addressed by the 65 selected articles is
presented.
5.1. Study characteristics
Thirty-seven articles reported TSP procedure previous experience, describing the
technique applied, the number of failures and the complication rate achieved. As a result, a
total of 15904 procedures were reported between 2008 and 2015
Regarding the new strategies proposed to overcome the main limitations of TSP
intervention, twenty-four studies suggested new intra-procedural guidance techniques. These
systems were validated in 958 humans, animal model and in vitro models. Five studies
suggested that pre-procedural planning of the procedure is crucial to identify a “safe puncture
zone”, validating these novel techniques in 211 humans. Finally, twenty-one works focused on
novel surgical equipments. 5269 procedures, animal model experiments and in vitro studies
were used to validate the novel surgical tools.
5.2. Incidence Study
Table 4 presents a review of the total number of TSP procedures performed between 2008
and April of 2015. Note that the procedures were not only performed in normal atria anatomy
situations. Several studies use heterogeneous population, which includes: children’s [31-33],
abnormal atria anatomy [20, 25, 34-41] or patients with previous TSP [15, 16, 24, 42-46]. The
number of puncture attempts, failures and complications were registered. The results show
that approximately 12% of the procedures require more than one puncture attempt to achieve
the FO position, and complications/failures rate are lower than 1% (Table 4).
6
Figure 2 - Overview of the methodology used to select the relevant papers for the current review.
Table 3 – Topics addressed in different reviews published between 2008 and 2015.
Year
2014
2012
Authors
Matsumoto et al. [2]
Kautzner et al. [47]
2011
Sy et al. [48]
2010
Tzeis et al. [49]
2009
Earley et al. [3]
2008
Babaliaros et al. [1]
2008
Ross et al. [17]
Aims
Recent advances in transseptal left heart interventions.
Review of imaging techniques used in LA procedures.
Overview of difficulties and possible solutions throughout
TSP procedure.
Exhaustive review of TSP procedure and overview of tips and
caveats with relevant value for safe TSP.
Review of TSP procedure complications and possible solutions.
Review of novel techniques used in TSP intervention and
emerging indications of this intervention.
Overview of transseptal left heart catheterization procedures.
Figure 3 – Results of the search performed on three online databases. (a) Distribution per year of the studies used in
the current review. (b) show the number of selected works from PubMed, ISI Web of Knowledge and Scopus when
the search expression was “transseptal puncture”. Note that the total number of search results is also presented.
7
5.3. Intra-procedural guidance techniques
Although the traditional TSP procedure only uses bidimensional fluoroscopy as unique
guidance strategy [18], several authors proposed the application of new image modalities,
namely: transesophageal (TEE) [35, 50-55], intracardiac echocardiography (ICE) [19, 56-60],
real-time magnetic resonance (MR) [61] and direct color visualization [62]. Furthermore,
needle tracking based on electromagnetic sensors [63] and electroanatomic mapping (EM) [33,
64-69] were also presented. These novel guidance techniques increase the safety of the TSP
procedure [19, 50, 56, 67], reduce or completely eliminate the radiation from the procedure
[33, 56, 57, 63, 64] and remove the contrast injection to confirm correct LA access [57].
Moreover, quickly procedures were performed [57] and a higher success rate in difficult
situations were achieved [19, 50].
As a final remark, Table 5 presents an overview of the different guidance techniques
applied in TSP procedures.
5.4. Pre-procedural planning techniques
Some authors proposed new pre-interventional planning techniques, namely:
identification of a safe zone to perform the puncture [46, 70-72] and identification of the
optimal puncture position, which guarantee maximum catheter dexterity inside the LA [73].
This planning step relies on pre-interventional image acquisition, namely: CT [70, 71, 73],
MR[73] or TEE [46, 72]. The authors agreed that these novel planning methods allow accurate
planning of the TSP procedure, increasing therefore the safety of TSP and reducing
complication and failures rate [70, 73].
As a final remark, Table 6 presents the aims, validation and conclusion of these novel
studies.
5.5. Surgical instruments
In the last years, a high number of studies focused on the traditional BRK needles. This
needle crosses the septum using a mechanical process, based on pressure applied on FO
region. Nonetheless, in abnormal septal wall (e.g. aneurysmal or elastic) high pressure can
result in inadvertent puncture and consequently, intervention complication [15]. As such,
novel transseptal needles were proposed to overcome the limitations of the BRK needle,
namely: RF rigid NRG needle (Baylis Medical) [15, 16, 22, 24, 44, 74-76], RF flexible Toronto
needle (Baylis Medical) [34], electrocautery needle technique [42, 77-80] and coaxial
transseptal (CTS) needle [81].
Furthermore, some authors proposed novel solutions for the remaining surgical
equipment’s, namely: dilator, guidewire and catheters. Thereby, a new dilator approach [21], a
laser catheter and a nitinol guidewire with “J” shape [37, 38, 82] were suggested to prevent
inadvertent puncture and reduce complication rate.
A robotic remote navigation system, based on Sensei framework, was also suggested to
perform safe LA interventions. This system was applied throughout TSP intervention and
ablation of atrial fibrillation [69].
Finally, Table 7 presents an overview of this novel surgical equipment’s.
8
Table 4 – Number of TSP, percentage of repeated procedure, failures and complications reported between 2008 and
2015.
Year
Authors
2015
2014
2014
2014
2014
2014
2014
2013
2013
2013
2013
2013
2012
2012
2012
2012
2011
2011
2011
2011
2011
2011
2010
2010
2010
2010
2010
2009
2008
2008
2008
2008
2008
2008
2008
2008
2008
Jauvert et al. [34]
Alvensleben et al. [31]
Koermendy et al. [83]
Lehrmann et al. [43]
Tang et al. [25]
Unnithan et al. [67]
Zellerhoff et al. [40]
Chierchia et al. [84]
Esch et al. [44]
Hsu et al. [16]
Katritsis et al. [85]
Yao et al. [18]
Bayrak et al. [35]
Mulder et al. [39]
Wang et al. [21]
Yao et al. [36]
Abed et al. [79]
Fromentin et al. [15]
Miyazaki et al. [41]
Wadehra et al. [37]
Winkle et al. [75]
Elayi et al. [32]
Haegeli et al. [23]
Mitchell-Heggs et al. [19]
Schwagten et al. [4]
Smelley et al. [24]
Wieczorek et al. [38]
Ferguson et al. [56]
Chierchia et al. [52]
Clark et al. [33]
Hu et al. [45]
Knecht et al. [42]
Knecht et al. [14]
Lakkireddy et al. [20]
Saliba et al.[69]
Wu et al. [55]
Tomlinson et al. [46]
Mean (%):
Number of
TSP
225
365
147
678
3452
54
39
103
10
72
393
120
205
634
4443
539
543
241
114
210
1550
13
269
79
11
41
158
21
24
10
29
269
203
90
40
468
42
Repeated
puncture
5.78%
14.17%
46.34%
1.11%
1.84%
20.33%
16.67%
15.38%
0%
4.47%
35.96%
35.71%
12.41%
Failure
Complications
0
0
4
0
0
0
0
0
1
10
0
5
1
4
0
0
10
0
5
13
0
0
0
1
1
0
0
0
0
0
0
0
1
2
0
0
0.37
3
8
20
0
10
1
1
9
0
2
5
6
3
27
0
10
2
1
0
9
0
8
9
0
0
0
0
0
0
0
0
0
4
1
1
4
0.91
9
Table 5 – Novel intra-procedural guidance techniques applied in TSP procedures between 2008 and 2015.
Year
Authors
Aims
Guidance technique
Validation
Conclusion
2015
Gafoor et al. [51]
Use of EchoNavigator in TSP.
3D TEE fused with
fluoroscopy.
-
This system showed potential for safe and simple TSP procedure.
2014
Faletra et al. [53]
Application of 3D TEE in TSP.
3D TEE
-
2014
Jeevan et al. [63]
2014
Mah et al. [68]
Electromagnetic sensor
fused with MRI.
EM combined with ICE
25 patients
2014
Pavlović et al. [66]
EM (Carto 3).
25 patients
A radiation-free recrossing of the IAS wall was achieved.
2014
Unnithan et al. [67]
EM (3D NavX).
54 patients
The method reduced the time that catheter dwells in LA.
2013
Nguyen et al. [65]
Validation of a new image-guided
method for radiation-free TSP.
EM with ICE to simple TSP.
Strategy to simple reaccess of FO
without radiation.
Strategy to simple reaccess of FO
without radiation.
Strategy to manual or automatic
reaccess of FO without radiation.
3D TEE easies TSP procedure when compared with remaining guidance
approach, such as 2D TEE or fluoroscopy.
This system reduced the procedure time, had no learning curve and
can reduce the number of complications.
The proposed system reduced the radiation exposure and time.
EM (Ensite/NavX).
5 patients
Manual and automatic reaccess of the LA is viable and fast. Moreover,
radiation exposure was removed.
2013
Ruisi et al. [58]
Application of ICE in TSP procedure
ICE
-
ICE can be used to guide TSP.
2013
Russo et al. [59]
Application of ICE in TSP procedure
ICE
-
ICE contributes to improve the efficacy of TSP procedure.
2013
Yao et al. [18]
Validation of a new TSP procedure.
Fluoroscopy.
120 patients
This method was simple, safe and economic.
2012
2012
2011
2011
Bayrak et al. [35]
Biermann et al. [60]
Faletra et al. [50]
Stec et al. [54]
2D-TEE and fluoroscopy.
ICE
3D TEE.
Micro-TEE probe
105 patients
12 patients
2010
Liang et al. [57]
Application of 2D TEE in TSP.
Application of ICE in TSP procedure
Advantages of 3D-TEE in TSP.
Application of micro-TEE in TSP.
Comparison between mechanical
versus phase-array ICE in TSP.
ICE.
6 patients
A correct puncture position was achieved.
ICE contributed to improve the efficacy of TSP procedure.
3D TEE allows simple FO identification.
Micro-TEE can be used to guide TSP in non-sedated patients.
Mechanical ICE has a better image of the FO, being therefore more
adequate to perform TSP.
Advantages of ICE in TSP.
ICE.
79 patients
2010
2009
2008
2008
2008
2008
2008
2008
2008
Mitchell-Heggs et al.
[19]
Ferguson et al. [56]
Chierchia et al. [52]
1 phantom
Application of ICE to perform TSP.
ICE.
21 patients
Application of 3D-TEE in TSP
3D TEE
24 patients
EM combined with TEE in TSP can
Clark et al. [33]
EM combined with TEE
10 patients
be used to perform TSP
Elagha et al. [61]
Application real-time MRI in TSP.
Real-time MRI.
7 animals
Saliba et al. [69]
Combination of EM and ICE in TSP.
EM and ICE
40 patients
Shepherd et al. [64]
Application of EM mapping in TSP.
EM (EnSite NavX).
Thiagalingam et al.[62]
Full color visualization of FO.
Fiber optic and fluoroscopy.
6 swine
Wu et al. [55]
Application of TEE in TSP.
TEE
468 patients
A safe and well tolerated guidance of TSP was achieved.
Succeed TSP was achieved using ICE guidance technique.
TEE eased TSP. Moreover, lower procedural time was reported.
The proposed method can be used to eliminate the fluoroscopy used
throughout TSP procedure.
MRI-guided can be used to perform safe TSP procedure.
This system ensured safe TSP procedure.
EM can reduce the fluoroscopy time requires in TSP procedures.
Direct full color visualization can be used to identify FO.
TEE eased the identification of optimal puncture position.
10
Table 6 – Pre-procedural planning methods applied in TSP procedures between 2008 and 2015.
Year
Authors
Aims
2013
Schernthaner et al. [72]
2012
Wagdi et al. [70]
2011
Jayender et al. [73]
2011
Verma et al. [71]
Identification of FO region in CT.
2008
Tomlinson et al. [46]
FO thickness is a predictor of
difficult TSP procedure.
Preprocedural TEE can be used to
identify abnormal atria anatomy
Identification of a “safe zone” to
perform TSP.
Identification of optimal puncture
position.
Planning method
Validation
TEE
100 patients
CT.
20 patients
MR/CT.
One dataset
CT and EM (Ensite NavX). 49 patients
TEE.
42 patients
Conclusion
Pre-planning TEE provided accurate information of patient-specific
anatomy, which increases the efficacy and safety of TSP procedure.
CT can be used to predict feasibility of TSP procedure. Moreover, CT
image can be used to identify a safe puncture region.
A safe puncture position, that ensures maximum dexterity of
catheter, was achieved.
It was possible to detect FO in CT. Confirmation of the FO position
was performed using intra-procedural EM.
No relation was found between difficult TSP procedure and FO
thickness. The only valid predictor was the presence of diabetes.
11
Table 7 - Surgical instruments used in various TSP works between 2008 and April of 2015.
Year
Authors
2015
Giudici et al. [82]
2015
Jauvert et al. [34]
2014
Karagöz et al. [76]
2013
Esch et al. [44]
2013
Hsu et al. [16]
2012 Greenstein et al. [80]
2012
Wang et al. [21]
2011
Abed et al. [79]
2011
2011
Feld et al. [22]
Fromentin et al. [15]
2011
Uchida et al. [81]
2011
Wadehra et al. [37]
2011
Winkle et al. [75]
2010
Capulzini et al. [78]
2010
Crystal et al. [74]
2010
Ponti et al. [86]
2010
Smelley et al. [24]
2010
Wieczorek et al. [38]
2009 McWilliams et al. [77]
2008
Knecht et al. [42]
2008
Saliba et al. [69]
Aims
Instruments/Methods
Validation
Conclusion
Experience with nitinol guidewire.
Nitinol guidewire.
100 patients
This method is simple, inexpensive, quick and safe.
Evaluate the safety of a new RF
RF powered flexible
125 patients
Flexible needle was safer and more efficient than BRK needle.
powered flexible needle.
needle and BRK needle.
Advantages of NRG needle.
NRG and BRK needle.
3 patients
NRG needle eased the TSP procedure.
Application of RF needle in patients
NRG needle can be used to LA access in patients with congenital
NRG and BRK needle.
10 patients
with congenital heart disease.
heart disease, including cases where BRK needle failed.
Comparison of NRG and BRK needle.
NRG and BRK needle.
72 patients NRG needle allowed shorter procedure time and lower failure rate.
Difference of tissue coring between
Electrocautery and
Similar number of tissue coring was achieved by the two
Swine hearts
electrocautery and traditional TSP.
traditional TSP.
techniques.
Comparison of dilator method with New dilator method and
The new dilator technique was safer than the traditional one.
2292 patients
the traditional puncture strategy.
traditional TSP.
However, the novel method required longer procedure time.
Comparison between electrocautery Electrocautery technique
Electrocautery method was safe and cost-effective when compared
10 patients
techniques and traditional one.
and BRK needle.
with traditional one.
Comparison of NRG and BRK needle. NRG RF and BRK needle.
In vitro
NRG needle appears to be safer than traditional needle.
Comparison of NRG and BRK needle. NRG RF and BRK needle. 241 patients NRG needle showed superior performance than traditional needle.
CTS needle can perform safe TSP in animal model, even in situations
Validation of a novel CTS needle.
CTS needle
Animal model
where the BRK needle failed.
Assess safety and efficacy of a novel
Nitinol guidewire and
210 patients
The new method showed high success rate.
puncture method.
BRK needle.
Comparison of NRG and BRK needle. NRG RF and BRK needle. 1167 patients
NRG needle showed performance than traditional needle.
Comparison of electrocautery
Electrocautery technique
Electrocautery method is a safe and reproducible technique to
162 patients
technique and traditional needle.
and BRK needle.
perform TSP.
Validation of NRG needle.
NRG needle
Animal model
RF needle eased TSP procedure.
Comparison of a novel transseptal
Nitinol guidewire.
19 patients
The novel guidewire eased TSP procedure in 23% of the patients.
guidewire and traditional method.
Validation of NRG needle.
NRG needle.
41 patients
NRG needle was safe with low failure rate.
Validation of a novel nitinol guidewire Nitinol guidewire and
Nitinol guidewire appears to be safe and effective in a subset of
158 patients
in TSP procedure.
BRK needle.
patients at higher risk for complications.
Comparison of electrocautery
Electrocautery technique
350
The electrocautery technique eased TSP procedure.
technique and traditional needle.
and BRK needle.
procedures
Application of electrocautery needle
Electrocautery needle
269
Electrocautery provided simple and safe LA access, even in
technique in TSP
technique
procedures
situations where BRK needle failed.
Robotic remote steerable sheath
Robotic remove
This new system was safe with similar results when compared with
system to perform TSP puncture and
navigation system
40 patients
the conventional approach.
ablation of atrial fibrillation
(Sensei system)
12
6. Discussion
6.1. Incidence Study
Between 2008 and 2015, an average complication and failure rate lower than 1% was
reported by a large number of authors (see Table 4). These results are in accordance with
previous studies [3], proving that TSP is a safe and feasible technique in clinical practice.
Furthermore, we present the number of situations where a second attempt was required to
correct the alignment between the needle and FO. Approximately 12% of the procedures
required more than one puncture attempt, which increases the procedural time and the
radiation exposure. This last result could indicate that FO recognition/puncture is not
straightforward, claiming for novel guidance strategies and smart surgical equipment [75-77].
In 2012, Yao et al. published a clinical experience article about TSP procedure [78]. A total
of 539 puncture were reported, with success of 100% and first attempt puncture of 98.9%.
Similarly, Alvensleben et al. and Elayi et al. proved that TSP can be safely applied on children’s
[76, 79] with a low complication rate (0.3%, [76]). Yao et al. and Bayrak et al. discussed the
difficulties of TSP on unexperienced hands [18, 35], proving that higher failure rate and large
procedural time are achieved by trainees. Moreover, Schwagten et al. presented an interesting
comparison between LA access through TSP and TA approach. 22 patients were used in this
experiment. Regarding the results, similar complication and failure rate was achieved by the
two strategies. Note that one and two failures were registered with TSP and TA approach,
respectively [4].
Several authors focused on clinical studies to identify the main complication and
limitations of TSP procedure [14, 25, 40, 43, 45, 83-85]. The authors reported that:
1) cardiac tamponade is the main cause of complications and catheter technology should
be improved to reduce the procedure complications [40, 85];
2) any consensus was found between LA access through PFO or TSP procedure. Lehrmann
et al. and Knecht et al. agreed that TSP procedure results in lower complication rate
[43] and allow simple maneuverability of the catheter inside the LA [14] when compared
with PFO access. However, Koermendy et al. and Miyazaki et al. published clinical
reports proving that LA access through PFO is safe with higher success rate and lower
complication rate when compared with TSP [41, 83];
3) repeated TSP presented higher complication rate and higher number of puncture
attempts [45] when compared with patients without any previous procedure;
4) anterior, medial and posterior FO are the optimal puncture position, with equal
complication rate and maximum catheter dexterity [84].
In order to ease left heart procedures, multiple catheters placed through double TSP was
suggested [20, 23]. Haegeli et al. performed 269 procedures using double puncture and low
complication rate (approximately 3%) was reported [23]. Similarly, Lakkireddy et al. applied
the same technique in 90 patients with only one failure and a complication rate of 4% [20]. As
such, the authors agreed that double TSP increases the catheters maneuverability inside the
LA [23].
Finally, a high number of studies focused on novel TSP techniques and its comparison
against the traditional technique [15, 16, 19, 21, 23, 24, 33, 34, 37, 38, 44, 52, 56, 67, 69, 75,
79]. The comparison was performed in a high number of patients and the authors proved that
new methods (e.g. radio-frequency needles, guidance with ICE and TEE) reduce the number of
13
complication and failure rate. Additionally, a reduction of the procedural time and radiation
exposure was commonly achieved.
6.2.Intra-procedural guidance techniques
Several authors proposed novel image guidance techniques, based on TEE or ICE, to
overcome the main limitations of the fluoroscopy-based procedures, namely: 1) bidimensional
acquisition with low contrast between the relevant structures and the neighbors; and 2)
continuous radiation exposure.
TEE is a real-time imaging technique where a specialized probe is advanced into the patient
esophageous. Note that general anesthesia is required. Since the transducer is positioned near
the cardiac structure, a clear (2D or 3D) image of the relevant structures is obtained.
Nonetheless, a small field of view of the region of interest is obtained.
Wu et al. and Chierchia et al. suggested the application of 2D [55] and 3D [52] TEE,
respectively, in TSP procedure to correct the alignment between the needle and FO position.
The authors validated this novel image guidance approach in humans. A low complication rate
and any failure were reported, proving therefore the safety and feasibility of the new method
in clinical practice. Furthermore, lower procedural time were reported [52, 55]. Faletra et al.
presented extended reports about atria anatomy interpretation in real-time 3D TEE [50, 53].
They proposed that 3D TEE is useful in pre-procedural planning step and during the TSP
procedure, due to the clear definition of the “true” septum border. Moreover, Bayrak et al.
proved that TEE allows simple recognition of the anatomical structures and it is essential to
safe TSP in unexperienced hands [35]. Finally, Gafoor et al. recently proposed the application
of the novel EchoNavigator system (Philips Inc., Amsterdam, Netherlands) on the TSP
procedure [51]. The EchoNavigator automatically combines 3D TEE image with 2D fluoroscopy,
which allows simple catheter guidance until the target site. Note that 3D TEE and fluoroscopy
ease FO recognition and instruments tracking/identification, respectively. As such, the
physician can introduce several landmarks on the 3D image obtained from TEE (e.g. optimal
puncture position) and accurately visualize them in the traditional fluoroscopic image.
Although this system presented promising results, any validation study was reported [51].
Since TEE requires high level of sedation with high costs, micro-TEE probe was suggested to
overcome this limitation. Stec et al. applied the novel method in 12 non-sedated patients
without any failure. Moreover, a clear image of IAS wall was achieved, proving that this image
guidance approach can be safely used in TSP procedure [54].
Similarly, ICE imaging was also proposed as an interesting solution for inexpensive and safe
TSP procedure. This technique acquires real-time ultrasound imaging through an instrumented
catheter positioned into the RA. This catheter has an ultrasound transducer at the catheter tip
and high sedation level is not required. Mitchell-Heggs et al. applied ICE guidance in 79
procedures with a complication rate of 11%. Furthermore, the authors also reported that this
image technique can be used to confirm correct needle position inside the LA [19]. Similarly,
Ferguson et al. proved that ICE guarantee safe TSP, through the application of this technique in
21 situations without any complication [56]. Liang et al. compared two ICE techniques in order
to identify the optimal strategy for TSP procedure, namely mechanical ICE and phase-array ICE.
Mechanical ICE uses a non-flexible catheter, with a bidimensional image generated
perpendicularly to the catheter. In opposition, phase-array ICE uses a flexible catheter, shows
color Doppler functions and uses multiple transducers controlled electronically to produce a
14
wedge shaped image. Both methods showed a clear image of the IAS and FO [57]. However,
since mechanical ICE has a better near field view, needle guidance inside the RA is simpler.
Additionally, mechanical ICE is a lower cost strategy [57]. Finally, several authors presented
interesting extended reports about ICE image guidance during TSP procedure, where a
detailed explanation about the image acquisition strategy and atria anatomy interpretation in
ICE is presented. [58-60]. Furthermore, the authors also mentioned that ICE is crucial for
identification/prediction of adverse events, reducing therefore the number of complications
and failures [60].
Elagha et al. and Thiagalingam et al. proposed different image-guidance strategies based on
real-time MRI [61] and direct full color visualization [62], respectively. Regarding the first
strategy, the authors applied an interactive, multi-slice real-time MRI using steady free
precession pulse sequences. Since the patient is positioned inside the MRI machine, some
equipment (e.g. catheters) was modified. As a result, the authors proved that transseptal
needle and FO region can be accurately identified with this imaging technique. The method
was tested in animal models without any complication [61]. Thiagalingam et al. proposed
direct visualization of the IAS through a fiber optic catheter. A real-time visualization of IAS
was achieved through a connection between the fiber optic and a monitor. Moreover, a
pressurized bag of saline solution, connected to the fiber optic, was used to clean the blood
from the top of the camera. TSP was performed in animal models without any complication.
Furthermore, post-mortem analysis showed a high correlation between puncture site and real
FO position. As a final remark, although these two methodologies presented large potential to
a safe and quick guidance of the TSP, human validation is missing [61, 62].
Instead of novel image guidance methods, Yao et al. proposed a modification of the
traditional TSP procedure. Similarly to the traditional approach, this new method is also guided
by fluoroscopy, being therefore an inexpensive and attractive solution [18]. Nevertheless, in
this solution a distal CS catheter is used and positioned on the lateral marginal of the heart,
consequently defining the level of FO at posterior-anterior projection of fluoroscopy. As such,
after an initial alignment between the needle and FO, using the traditional TSP procedure, a
confirmation of the needle site is performed using the CS catheter site. In this confirmation,
the physician verifies if the TSP needle is positioned between the distal CS catheter and the
peak posterior margin of LA at RAO direction of fluoroscopy. Finally, the needle can safely
puncture the FO until LA. The current method was applied in 120 patients with mean
complication rate and failure rate of 5% and 4%, respectively [18].
Several studies proposed novel guidance methodologies based on electroanatomic
mapping (EM) [33, 64, 68, 69] and electromagnetic sensors [63], respectively. The authors
suggested that fluoroscopy time can be notably reduced [64, 68] or removed [33] from TSP
procedure, therefore presenting clear advantages for the physician and the patient. Shepherd
et al. used the EM technique to generate a 3D model of the atria and to guide the transseptal
needle until the FO. Nonetheless, any clinical validation was performed. Moreover, since EM
technique does not provide real-time geometries, a sub-optimal guidance approach was
achieved [64]. As such, Mah et al. suggested the combination of EM and ICE to reduce the
fluoroscopy exposure time. The proposed approach was applied in clinical practice, where a
significant reduction of the fluoroscopy dose and time was observed [68]. Similarly, Saliba et
al. applied the same technique (EM combined with ICE) in a robotic remote navigation system
15
to perform TSP procedure. The entire framework was tested in 40 patients, showing similar
complication and failure results when compared with the traditional approach [69].
Instead of ICE imaging, Clark et al. presented a novel system where EM data is fused with
real-time TEE. The optimal puncture is performed in two steps: 1) identification of the optimal
puncture position and adverse events using the RA geometry generated by EM; 2)
confirmation of the correct alignment between the needle and puncture site using TEE. The
proposed system was applied in 10 patients without any complication or failure. Furthermore,
fluoroscopy time and exposure was not required [33]. Finally, Jeevan et al. proposed a
different strategy to guide the physician throughout transseptal puncture procedure. In this
strategy, an electromagnetic sensor was positioned on the tip of the catheter and it was rigidly
aligned with a patient specific atrial model, which was obtained from a pre-interventional MRI.
This register was performed through a set of fiducial markers positioned on the real and virtual
atria model. Note that the fossa ovalis position is also represented by a specific fiducial
marker. As such, during the intervention the electromagnetic system indicates the optimal
catheter trajectory until the puncture site. The current system was simulated in one phantom
model, being the procedure performed quickly without any complication. However, this
system was only tested in static models being far from being applied in real situations [63].
Recent studies suggested that left-sided catheter dwelling time appears to be associated
with bleeding, clotting, endothelial dysfunction or char particle embolization [67]. As such,
multiple LA access through TSP is required to reduce the catheter dwelling time into LA, and
consequently reduce the abovementioned complications [67, 87]. However, multiple LA access
is time-consuming, frustrating, require large radiation dose and can originate serious
complications [65]. Interesting solutions to quick and safe LA reaccess without any radiation
were proposed in [65-67]. All the strategies use EM to generate geometry of the atria region
and create a marker of the TSP site. Unnithan et al. and Pavlović et al. validated this
methodology in 10 and 5 patients, respectively. Quick access without any complication was
reported (approximately 14 seconds) [66, 67]. Additionally, Nguyen et al. proposed a new
remote magnetic catheter navigator system that allows “manual” and “automatic” LA reaccess
[65]. The automatic remote navigator system relies on 8 electromagnetics positioned along the
patient. These electromagnetics will modify the magnetic field applied, when a correction of
needle position or pose is required to achieve the target site. This technique was applied with
success in 5 patients, taking 6.2±8.1 seconds and 30.4±28.4 seconds in automatic and manual
operation mode, respectively [65].
6.3. Pre-procedural planning techniques
The novel pre-procedural planning methods for transseptal puncture procedure focused on
pre-interventional imaging, namely: CT [70, 73], MR [73] or TEE [46, 72]. Wagdi et al. reported
that TSP is challenging in situations where larger devices sizes (e.g. amplatzer) have been
applied to interatrial septal communication closure. As such, they suggested the analysis of a
pre-interventional CT dataset to define a “safe zone” for TSP. Note that the identification of
this “safe zone” will be crucial to assess the feasibility of the procedure. This study was
performed on 20 patients, and the results proved that CT dataset can predict the feasibility
and safety of TSP. Similarly, Schernthaner et al. applied TEE imaging to predict the feasibility of
TSP, proving that TEE can be used to identify patients with abnormal IAS wall anatomy [72].
Tomlinson et al. suggested that FO thickness is a predictor of the difficulty of TSP procedure.
16
Thus, since the wall thickness can be easily observed in TEE images, a total of 42 patients were
assessed by ultrasound imaging and posteriorly classified (difficult or not difficult procedure)
during the pre-procedural planning phase. This initial classification was subsequently
compared with the difficulty of the real procedure, being not found any correlation between
wall thickness and difficult procedure. Finally, Jayender et al. proposed a novel approach for
optimal puncture location estimation. This strategy combines pre-interventional anatomical
models with a mechanical model of the catheter to simulate the puncture procedure. As such,
a finite element method was used to estimate the optimal puncturing site based on the
thickness of the septal wall and the mechanical maneuverability of the catheter at all the
positions of the LA. [73]. The current system was only tested in one offline dataset, missing
application in clinical practice.
6.4. Surgical instruments
New surgical instruments were also presented to increase the efficiency of the TSP, with a
notable number of works focused on the transseptal needles. Although the mechanical BRK
needle appears to be safe in non-complex procedures, the same is not observed in abnormal
atria anatomy or in patients with previous procedure. As such, NRG needles [15, 16, 22, 24, 34,
44, 74-76] and electrocautery needles [42, 77-80] were proposed.
NRG is a rigid needle that uses RF energy to diminish the septal wall resistance, reducing
therefore the mechanical force required for FO puncture. This needle presents a novel design,
with an oval tip to prevent inadvertent puncture. Furthermore, a radiopaque marker was
incorporated inside this equipment to simple needle guidance in fluoroscopy-based methods
[22]. Regarding the clinical practice, any significant modification of the traditional puncture
procedure is required, easing therefore the introduction of this new instrument [15].
In 2010, Crystal et al. and Smelley et al. demonstrated that NRG needles can be used to
perform safe TSP, principally in difficult procedures [24, 74]. The method was validated in: 1)
animal model [74]; and 2) 35 patients [24]. Although animals with complex anatomy (e.g. PFO)
were used, any complication was found [74]. Regarding the clinical validation, only one failure
was registered. As such, the results showed that NRG needle could be used to perform safe
TSP even in abnormal atria anatomy [24, 74].
Subsequently, several authors presented large clinical studies where a comparison between
NRG needle and the conventional one is performed [15, 16, 34, 44, 75, 76, 88]. The authors
agreed that NRG reduces the procedural time, the complication rate, the failure rate and
facilitates the procedure in presence of complex anatomies when compared with the
traditional strategy [15, 44, 75, 76]. Note that randomized single blinded studies have also
been used to validate the abovementioned conclusions [16]. Moreover, Feld et al. proved that
BRK needle can introduce plastic particles into the circulatory system of the patient, which can
originate microinfarcts and left ventricular dysfunction. These particles are created due to a
process of skiving when the needle is advanced along the plastic dilator. NRG needle was also
tested and any plastic particle was found [22]. Although NRG needle appears to present a
superior performance when compared with the traditional equipment, several theoretically
risk should be considered, namely: 1) inadvertent cardiac puncture using RF can result in
greater consequences for the patient; 2) puncture site is less likely to close spontaneously; and
3) the RF puncture can be more traumatic for the FO [24].
17
Recently, a novel RF powered flexible needle, termed Toronto needle was proposed [34].
This equipment presents: 1) an active operating mode based on RF energy; and 2) a novel
catheter design which guarantees safe puncture of the FO and prevent inadvertent puncture
thanks a flexible catheter with large J shaped distal curve. Jauvert et al. compared the Toronto
and BRK needle in humans. 125 punctures were performed with Toronto needle, and 100
punctures with the traditional approach (BRK needle). The results demonstrated that Toronto
needle has a superior performance, lower number of failures (5% for BRK and 0% for Toronto
needle) and lower complications rate (7% for BRK and 0% for Toronto needle) rate when
compared with traditional approach [34].
Electrocautery pen combined with traditional BRK needle was also proposed to ease septal
wall cross [42, 77-80]. In this method, the traditional TSP procedure is initially performed to
align the needle with the FO region. Subsequently, the cautery pen (15-20W) is applied (during
approximately 1-2 s) on the proximal portion of the needle [77, 78], cauterizing the FO region
and reducing consequently, the pressure required to perform the FO cross. Similarly to the
NRG and Toronto needle, this novel approach reduces the complication and failure rate when
compared with the BRK needle, mainly in highly elastic, aneurysmal, or fibrotic septal wall [42,
77-79]. Finally, Greenstein et al. compared both techniques to verify the incidence of tissue
coring into the needle tip [80]. It should be noticed that coring of the septal wall can originate
complications, such as systematic embolization. The study was performed in animal models
and the results showed a similar number of tissues coring (approximately 35% of the
punctures) with both approaches, raising questions about the real safety of the TSP
intervention.
On the other hand, Uchida et al. proposed a novel mechanical transseptal needle, termed
coaxial TS needle. This novel needle is longer than the traditional one, showing high safety and
feasibility in 10 punctures performed at 10 animal models. Note that LA access was not
achieved with the traditional needle in the abovementioned animal models [81].
Although several authors proposed and validated novel transseptal needle to safe TSP
procedure, novel solutions were also presented for the remaining equipment, namely: nitinol
guidewire [37, 38, 82, 86] and laser catheters [61]. Nitinol guidewire (SafeSeptTM, Pressure
Products Inc., San Pedro, USA) presents a “J” preformed with 0.014″ wire and sharp-distal tip.
This novel equipment is positioned inside the needle assuming two different shapes, namely:
1) a straight shape when the guidewire is completely positioned inside the needle; and 2) a “J”
shape when the guidewire is outside of the needle. The straight guidewire shape facilitates
catheter manipulation and “J” guidewire shape prevents inadvertent punctures. Furthermore
this novel guidewire has a radiopaque marker at the guidewire tip, easing therefore
instrument identification in fluoroscopy. This novel solution was compared with the traditional
TSP strategies in humans, showing a high success rate even in difficult procedures [37, 38, 82,
86]. Moreover, Wadehra et al. suggested that the nitinol guidewire is a safe and useful
alternative for the expensive TSP procedures based on 3D image guidance [37].
Elagha et al. proposed a laser catheter for TSP procedure guided by real-time MRI. A
receiver coil, positioned at the catheter tip, was used to generate a bright spot that can be
easily detected on MRI. This new system was validated in animal model, proving that the laser
catheter can be accurately detected in real-time MRI [61]. Furthermore, the novel system
proved to be safe and quick for TSP procedures.
18
Some authors suggested that robotic remote navigation system (Sensei) can be used in LA
interventions, such as transseptal puncture. The robotic system allows better catheter
stability, precise positioning of the surgical equipment and simple catheter maneuverability,
increasing therefore the safety of the procedures. Clinical validation was reported, being
registered only one intra-procedural complication [69].
Finally, Wang et al. proposed a different TSP strategy, where different surgical tool
configuration is used. This novel method, termed dilator method, presents the follow
modifications: 1) the outer sheath was removed from the procedure, being only required the
dilator and a transseptal needle; and 2) the transseptal needle was kept inside the dilator
during the entire guidance procedure [21]. As such, the identification of the lip edge of the FO
was performed using the dilator. Since the dilator presents a blunt tip, FO identification was
eased. A comparison between the novel method and the traditional one was performed in a
total of 4443 patients. The results suggested that the dilator technique is much safer than the
traditional approach, with a reduction of the number of severe complications (see Table 4).
Nevertheless, an increase of the procedure time and radiation time was registered with this
novel approach [21].
7. Conclusions
The current study presents an overview of novel techniques/frameworks recently applied in
TSP procedure. TSP is safe and feasible in clinical practice, with complication and failure rate
lower than 1% of the total number of interventions. Nonetheless, the traditional procedure
uses radiation and it is dependent of the physician experience. Since TSP is entirely based on
experience, serious complications for the patient can occur, primarily in the presence of
abnormal IAS wall anatomy, showing that a sub-optimal methodology is being used to access
the left heart.
The novel RF needles or the recent 3D guidance approaches showed a notable reduction of
procedural time and radiation exposure time. A lower number of procedural complications and
failures were also reported even in the presence of complex atria anatomy, proving the
advantages of these novel methodologies throughout the puncture intervention. Furthermore,
since both systems can be easily adapted into the surgical room, their future application in a
large number of LA access interventions is expected. Nonetheless, exhaustive clinical validation
of several novel techniques is still missing.
Finally, pre-procedural planning based on high-resolution imaging appears to be a crucial
stage to predict the feasibility of the TSP procedure. Moreover, these strategies can be used to
identify a safe puncture zone that guarantees maximum catheter dexterity throughout the
remaining LA intervention.
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25