https://orcid.org/0000-0001-7876-8691
Abstract
This study was performed to compare the usability, efficiency, and safety of a modified angioplasty guidewire-assisted transseptal puncture (TSP) technique vs. the conventional approach in facilitating access into the left atrium during left atrial appendage occlusion (LAAO) procedures for the treatment of atrial fibrillation.
The ADVANCE-LAAO trial (Angioplasty Guidewire-Assisted vs. Conventional Transseptal Puncture for Left Atrial Appendage Occlusion) was an investigator-initiated, prospective, multicentre, randomized controlled trial (NCT05125159). Patients with atrial fibrillation who underwent LAAO were prospectively enrolled from four centres and randomly assigned to an angioplasty guidewire-assisted TSP group (n = 131) or to a conventional Brockenbrough needle TSP group (n = 132). The primary endpoint was the one-time success rate of TSP. We also analysed the TSP procedure time, failure rate of the assigned TSP type, radiation dose, contrast dose, and procedural complications in both groups. All patients in the guidewire-assisted group underwent successful TSP, whereas five in the standard conventional group switched to the guidewire-assisted approach. The guidewire-assisted puncture improved the one-time success rate (92.4 vs. 77.3%, P = 0.001), shortened the TSP procedure time (109.2 ± 48.2 vs. 120.5 ± 57.6 s, P = 0.023), and tended to have a higher rate of good coaxial orientation of the sheath with the left atrial appendage during the LAAO procedure (66.4 vs. 54.5%, P = 0.059). No TSP-related complications occurred in the guidewire-assisted TSP group, whereas two complications occurred in the conventional TSP group. There was no significant difference in the failure rate of the assigned TSP type, the total procedure time, the total radiation dose, the rate of successful LAAO implantation, or the procedural complication rate between the two groups (all P > 0.05).
This study confirmed that angioplasty guidewire-assisted puncture can effectively improve the success rate of TSP during LAAO procedures. This novel technique has high potential for application in interventional therapies requiring TSP.
We have pioneered a modified angioplasty guidewire-assisted transseptal puncture (TSP) method called the ATP technique for facilitating access into the left atrium (LA) during left atrial appendage occlusion (LAAO) procedures and performed the first randomized controlled comparison of this novel technique with the conventional approach.
The ATP technique effectively improved the one-time success rate, shortened the time taken to perform TSP, and tended to obtain higher rates of good coaxial orientation of the sheath with the left atrial appendage during LAAO.
This technique facilitated successful TSP in patients with a structurally abnormal atrial septum, such as an atrial septal aneurysm or a hypertrophic or a fibrotic atrial septum.
Introduction
Transseptal puncture (TSP) as a means of accessing the left atrium (LA) is a critical step in a variety of cardiac interventional therapies.1–7 This technology has been widely used for ablation of left-sided accessory pathways, radiofrequency or cryoballoon ablation of atrial fibrillation, percutaneous mitral valvuloplasty, percutaneous mitral valve repair, and LAAO. Conventionally, TSP is performed using a specifically designed Brockenbrough (BRK) needle under fluoroscopic guidance to mechanically puncture the fossa ovalis (FO).8
Although TSP is generally safe, serious complications such as perforation of the atrial wall or aorta can occur, especially in patients with an abnormal atrial septal structure (i.e. an atrial septal aneurysm or a hypertrophic or a fibrotic atrial septum). During the LAAO procedure, TSP is required to achieve access into the LA for the delivery of the sheath and occluder. A relatively inferoposterior TSP site in the fossa is generally technically desirable for the LAAO procedure because it provides good coaxial orientation of the sheath, causing it to point towards the ostium of the left atrial appendage (LAA).9 However, the use of this puncture site also increases the risk of complications.10
Our centre has pioneered a modified angioplasty guidewire-assisted TSP method, called the ATP technique, that includes two critical steps. First, the stiff tail of the 0.014″ guidewire is used to perform quick repeated punctures, forming a sieve mesh in the inter-atrial septum. This increases the efficiency of TSP and decreases breakthrough resistance, thereby reducing the risk of accidental puncture of adjacent structures. Second, the floppy tip of the same 0.014″ guidewire is used to confirm access into the LA by fluoroscopy without the need for injection of a contrast medium and is easily advanced into the left superior pulmonary vein (LSPV) to facilitate the advancement of the puncture assembly and marking of the LSPV for LAAO. This novel TSP technique has potential clinical value, especially in patients with an abnormal atrial septal structure. This study was performed to assess the safety, performance, and usability of this novel technique in facilitating access into the LA during LAAO procedures for the treatment of atrial fibrillation.
Methods
Trial design
The ADVANCE-LAAO trial (Angioplasty Guidewire-Assisted vs. Conventional Transseptal Puncture for Left Atrial Appendage Occlusion) followed a multicentre, prospective, randomized controlled design. Patients with non-valvular atrial fibrillation who underwent LAAO at four hospitals in China were consecutively enrolled. The trial was approved by the institutional review committee at each clinical centre and was conducted in accordance with the Declaration of Helsinki. This trial was registered at https://www.clinicaltrials.gov (unique identifier NCT05125159). The first and last authors had full access to the study data and take full responsibility for the decision to submit the report for publication.
Informed consent
All patients provided written informed consent and agreed to participate in the clinical study and data collection process.
Participants
Eligible participants were those older than 18 years, who had non-valvular atrial fibrillation, and had undergone LAAO requiring transseptal access and LA catheterization for stroke prevention. The following exclusion criteria were applied: previous LA ablation or LA surgery; documented intra-cardiac thrombus; pre-existing pulmonary vein stenosis or a pulmonary vein stent; pre-existing hemidiaphragmatic paralysis; contraindication to anticoagulation or the use of radiocontrast material; history of implantation of a cardiac valve prosthesis; myocardial infarction or percutaneous transluminal coronary intervention (percutaneous transluminal coronary angioplasty or coronary artery stenting) during the 3-month period preceding the consent date; cardiac surgery during the 3-month period preceding the consent date; significant congenital heart defects; significant chronic kidney disease (estimated glomerular filtration rate <30 mL/min/1.73 m2); uncontrolled hyperthyroidism; cerebral ischaemic event (stroke or transient ischaemic attack) during the 6-month period preceding the consent date; pregnancy; life expectancy of <1 year; current or expected participation in any other clinical trial of a drug, device, or biologic that had the potential to interfere with the results of this study; and unwillingness or inability to comply fully with the study procedures and follow-up.
Randomization and treatment
Between December 2021 and December 2022, 270 patients were randomized after screening according to the inclusion and exclusion criteria. Seven of these patients withdrew consent after randomization (Figure 1). Therefore, 263 patients (the guidewire-assisted TSP group, n = 131; the conventional BRK needle TSP group, n = 132) completed the treatments and endpoint assessments. Randomization in a 1:1 ratio was performed by an independent statistician using a computer-generated list.
Flow chart of participant enrolment in the ADVANCE-LAAO trial. LA, left atrium.
The patients were prospectively and randomly assigned to either of the two groups according to the TSP strategy used during the LAAO procedure. Clinical evaluation, laboratory tests, 12-lead electrocardiography, transthoracic and transoesophageal echocardiography, and computed tomography of the heart structures were performed before the LAAO procedure. In the guidewire-assisted TSP group, TSP was performed with angioplasty guidewire assistance (detailed in the section “Transseptal puncture during the left atrial appendage occlusion procedure”) and guided by intra-procedural fluoroscopy and echocardiography. In the standard conventional group, TSP was performed with a conventional BRK needle and guided by intra-procedural fluoroscopy and echocardiography.
Transseptal puncture during the left atrial appendage occlusion procedure
The LAAO procedure was performed under local anaesthesia. Transseptal puncture was performed via right femoral venous access. The routine equipments used in both groups are listed in Table 1. The puncture assembly (Abbott Laboratories, Abbott Park, Chicago, IL, USA) consisted of a Swartz sheath–dilator and a BRK needle in both groups. An angioplasty guidewire (i.e. 0.014″ Runthrough; Terumo Interventional Systems, Tokyo, Japan) with a stiff end was inserted into the inner cavity of the BRK needle in the guidewire-assisted TSP group, whereas a contrast-filled syringe was connected to the BRK needle in the standard conventional group. Our procedure was performed in accordance with the consensus recommendation of Chinese interventional cardiologists for a simplified LAAO workflow.11–13 This includes a transthoracic echocardiography-guided puncture of the atrial septum, without the requirement of monitoring by transoesophageal or intra-cardiac echocardiography throughout the procedure, and an option to use local anaesthesia because it provides the advantages of shorter operation and recovery times and is less harmful than general anaesthesia in the older population. For TSP, transoesophageal or intra-cardiac echocardiography was performed only in difficult cases at the operator’s discretion.
Equipment used for the transseptal puncture in both study groups
| Standard conventional group | Angioplasty guidewire-assisted group |
|---|---|
| SL1 sheath (Abbott Laboratories, Abbott Park, Chicago, IL, USA) | SL1 sheath (Abbott Laboratories, Abbott Park, Chicago, IL, USA) |
| 71 cm Brockenbrough needle (BRK, St Jude Medical) | 71 cm Brockenbrough needle (BRK, St Jude Medical) |
| 0.035″ J-tipped guidewire | 0.035″ J-tipped guidewire |
| Contrast-filled syringe | 0.014″, 180 cm angioplasty guidewire |
| Intravenous heparin | Intravenous heparin |
| Standard conventional group | Angioplasty guidewire-assisted group |
|---|---|
| SL1 sheath (Abbott Laboratories, Abbott Park, Chicago, IL, USA) | SL1 sheath (Abbott Laboratories, Abbott Park, Chicago, IL, USA) |
| 71 cm Brockenbrough needle (BRK, St Jude Medical) | 71 cm Brockenbrough needle (BRK, St Jude Medical) |
| 0.035″ J-tipped guidewire | 0.035″ J-tipped guidewire |
| Contrast-filled syringe | 0.014″, 180 cm angioplasty guidewire |
| Intravenous heparin | Intravenous heparin |
Equipment used for the transseptal puncture in both study groups
| Standard conventional group | Angioplasty guidewire-assisted group |
|---|---|
| SL1 sheath (Abbott Laboratories, Abbott Park, Chicago, IL, USA) | SL1 sheath (Abbott Laboratories, Abbott Park, Chicago, IL, USA) |
| 71 cm Brockenbrough needle (BRK, St Jude Medical) | 71 cm Brockenbrough needle (BRK, St Jude Medical) |
| 0.035″ J-tipped guidewire | 0.035″ J-tipped guidewire |
| Contrast-filled syringe | 0.014″, 180 cm angioplasty guidewire |
| Intravenous heparin | Intravenous heparin |
| Standard conventional group | Angioplasty guidewire-assisted group |
|---|---|
| SL1 sheath (Abbott Laboratories, Abbott Park, Chicago, IL, USA) | SL1 sheath (Abbott Laboratories, Abbott Park, Chicago, IL, USA) |
| 71 cm Brockenbrough needle (BRK, St Jude Medical) | 71 cm Brockenbrough needle (BRK, St Jude Medical) |
| 0.035″ J-tipped guidewire | 0.035″ J-tipped guidewire |
| Contrast-filled syringe | 0.014″, 180 cm angioplasty guidewire |
| Intravenous heparin | Intravenous heparin |
The main steps of TSP followed for the guidewire-assisted TSP group are shown in Figures 2 and 3 and in Supplementary material online, Video S1. In the posteroanterior view, we smoothly withdrew the whole puncture assembly from the superior vena cava (SVC) and observed it plunge into the right atrium and FO separately. The needle hub was rotated backwards to the 5- to 6-o’clock position during withdrawal. We then confirmed the correct location in the left anterior oblique 30° view and the right anterior oblique 45° view, and adjusted the degree of puncture under guidance by intra-procedural fluoroscopy and echocardiography. When the correct puncture site and degree of puncture were confirmed, we advanced the stiff end of the angioplasty guidewire and pierced the inter-atrial septum multiple times using the stiff end of the guidewire rather than the puncture needle, thereby creating a sieve mesh structure at the puncture point. The puncture needle was then delivered to the LA along the stiff end of the 0.014″ guidewire through the sieve mesh structure with little breakthrough resistance. Next, we withdrew the angioplasty guidewire, inserted the floppy tip of the same angioplasty guidewire into the inner cavity of the BRK needle, and introduced the tip into the LA and LSPV. The Swartz sheath–dilator was advanced into the LA along the Runthrough guidewire, and the BRK needle was withdrawn. The Runthrough guidewire was then changed to a 0.035″ J-tipped guidewire (Amplatz Super Stiff; Boston Scientific, Marlborough, MA, USA), which was advanced into the LSPV. Finally, the Swartz sheath was introduced into the LA along the guidewire and then upsized over the wire to the LAAO delivery sheath for the subsequent LAAO procedure.
Schematic diagram showing the angioplasty guidewire-assisted transseptal puncture procedure. (A) The puncture assembly (Swartz sheath, dilator, BRK needle, and stiff tail of the angioplasty guidewire) is placed in the SVC. (B) The BRK needle hub is rotated to the 5- to 6-o’clock position, and the whole assembly is slowly pulled back. (C) The centre of the FO (the ideal puncture site) is identified when two small jumps have been felt as the tip drops over the SVC into the RA. (D) The stiff tail of the angioplasty guidewire (0.014″ Runthrough) is advanced through the needle to pierce the inter-atrial septum multiple times, thus creating a sieve mesh structure at the puncture point. The puncture needle is then delivered into the LA along the stiff tail of the angioplasty guidewire through the sieve mesh structure with little breakthrough resistance. (E) The septum is crossed by the needle, the Runthrough guidewire is retracted, and the other end (floppy tip) of the guidewire is advanced into the LA and LSPV through the needle. (F) The dilator is advanced into the LA along the Runthrough guidewire, which is then exchanged for a 0.035″ J-tipped guidewire (Amplatz Super Stiff). (G) The sheath is introduced into the LSPV along the 0.035″ J-tipped guidewire. (H) All toolkits are withdrawn except for the sheath. BRK, Brockenbrough; FO, fossa ovalis; LA, left atrium; LSPV, left superior pulmonary vein; RA, right atrium; SVC, superior vena cava.
The workflow of angioplasty guidewire-assisted transseptal puncture. (A) The puncture assembly (Swartz sheath, dilator, BRK needle, and stiff tail of the angioplasty guidewire) is placed in the SVC. (B) The BRK needle hub is rotated to the 5- to 6-o’clock position, and the whole assembly is slowly pulled back. (C) The centre of the FO (the ideal puncture site) is identified when two small jumps have been felt as the tip drops over the SVC into the RA. (D) The stiff tail of the angioplasty guidewire (0.014″ Runthrough) is advanced through the needle to pierce the inter-atrial septum multiple times, thus creating a sieve mesh structure at the puncture point. The puncture needle is then delivered to the LA along the stiff tail of the angioplasty guidewire through the sieve mesh structure with little breakthrough resistance. (E) The septum is crossed by the needle, the Runthrough guidewire is retracted, and the other end of the guidewire (floppy tip) is advanced into the LA and LSPV through the needle. (F) The dilator is advanced into the LA along the Runthrough guidewire, which is then exchanged for a 0.035″ J-tipped guidewire (Amplatz Super Stiff). (G) The sheath is introduced into the LSPV along the 0.035″ J-tipped guidewire. (H) All toolkits are withdrawn except for the sheath. BRK, Brockenbrough; FO, fossa ovalis; LA, left atrium; LSPV, left superior pulmonary vein; RA, right atrium; SVC, superior vena cava.
In the conventional group, the puncture assembly consisted of a sheath, dilator, BRK needle, and contrast-filled syringe connected to the BRK needle. The puncture assembly was pulled down from the SVC to the FO, and the correct puncture site and degree were confirmed. The BRK needle then extended out of the dilator, fell onto the FO, crossed the septa, and entered the LA (within 1 cm from the septa) under pressure applied by the operators. Successful LA access was confirmed by FO tenting release, injection of the contrast agent within the LA, and aspiration of oxygenated blood through the needle. The operator then held the needle and successfully advanced the dilator and sheath. The needle was retrieved, and a 0.035″ Amplatz Super Stiff guidewire (Boston Scientific) was introduced into the LSPV via the assembly. Finally, the sheath was introduced into the inner LA. If the assigned TSP procedure was unsuccessful after three attempts, it was switched to the other type.
Primary and secondary study outcomes
The primary outcome of this trial was the one-time success rate of TSP for LA access. The secondary outcomes were the TSP procedure time for LA access, failure rate of the assigned TSP type, contrast agent dose used during TSP, radiation dose, and TSP-related complications. The total TSP procedure time consisted of the time from the sheath in SVC to the sheath in FO, the time from the needle in FO to the needle in LA, and the time from the needle in LA to the sheath in LA (Table 3). We also analysed the procedural efficiency during LAAO (i.e. the rate of good coaxial orientation of the sheath with the LAA, the success rate of the LAAO implantation, and the success rate of the LAAO implantation on the first attempt), the contrast dose during LAAO, the radiation dose, and the LAAO procedural complication rate.
All patients were monitored for both intra-procedural and post-procedural complications until discharge. Independent study monitors reviewed all source documents onsite for accuracy and completeness. Safety endpoints were verified by a blinded adjudication committee.
Sample size
The sample size in the present trial was estimated under the assumption that the success rate of one-time puncture would be 77% in the conventional group and 90% in the guidewire-assisted TSP group based on data from previous literature and our pilot study.6 Accordingly, a sample size of 125 patients per group was required to achieve 80% power to detect a difference of 13% with a unilateral approach and an α level of 0.025. With an expected 3% dropout rate, we determined that at least 258 patients should be enrolled. The power calculation was performed using PASS software version 15 (NCSS, LLC, Kaysville, UT, USA).
Statistical analysis
The primary analysis was performed using the full analysis set on a modified intention-to-treat basis. The statistical analysis was performed using SPSS software version 25.0 (IBM Corp., Armonk, NY, USA). Categorical variables are presented as the number and percentage of cases. Comparisons between groups were performed using the χ2 test or Fisher’s exact test. Continuous variables that conformed to a normal distribution are presented as the mean ± standard deviation and were compared between groups using the unpaired Student’s t-test. For repeated-measures data, an analysis of within-group measurements was performed using the paired t-test. Continuous variables that did not conform to a normal distribution are expressed as the median (inter-quartile range). Between-group comparisons were performed using the Mann–Whitney U test. Repeated-measures data were processed using the Wilcoxon two-sample test. A two-sided P-value <0.05 was considered statistically significant.
Results
Baseline characteristics
In total, 270 patients were consecutively enrolled in this study between December 2021 and December 2022. As shown in the flow chart in Figure 1, a total of 131 patients in the guidewire-assisted TSP group and 132 patients in the standard conventional group completed the final analysis and follow-up. The details of their clinical characteristics are shown in Table 2. There were no significant between-group differences in any of the baseline clinical characteristics (all P > 0.05).
Baseline characteristics of patients
| Angioplasty guidewire-assisted group (n = 131) | Standard conventional group (n = 132) | P-value | |
|---|---|---|---|
| Clinical characteristics | |||
| Age (years) | 69.8 ± 8.3 | 68.1 ± 9.6 | 0.171 |
| Female, n (%) | 45 (34.4) | 43 (32.6) | 0.929 |
| Atrial fibrillation pattern | |||
| Paroxysmal, n (%) | 61 (46.6) | 54 (40.9) | 0.355 |
| Persistent or permanent, n (%) | 74 (56.5) | 81 (61.4) | 0.422 |
| Atrial fibrillation duration (months) | 17 (3.60) | 24 (6.72) | 0.670 |
| CHA2DS2-VASc score | 3.6 ± 1.4 | 3.7 ± 1.2 | 0.645 |
| HAS-BLED score | 2.5 ± 0.7 | 2.4 ± 0.6 | 0.211 |
| Concomitant diseases | |||
| Ischaemic stroke, n (%) | 80 (61.1) | 67 (50.8) | 0.092 |
| Haemorrhagic stroke, n (%) | 4 (3.1) | 9 (6.8) | 0.159 |
| Hypertension, n (%) | 94 (71.8) | 90 (68.2) | 0.527 |
| Diabetes mellitus, n (%) | 33 (25.2) | 28 (21.2) | 0.445 |
| Coronary artery disease, n (%) | 30 (22.9) | 25 (18.9) | 0.430 |
| Heart failure, n (%) | 8 (6.1) | 15 (11.4) | 0.131 |
| Laboratory examination | |||
| INR | 1.1 ± 0.3 | 1.2 ± 0.3 | 0.196 |
| Serum creatinine (mmol/L) | 80.5 ± 23.4 | 77.9 ± 26.2 | 0.398 |
| ALT (U/L) | 22.7 ± 10.6 | 23.3 ± 11.0 | 0.659 |
| AST (U/L) | 22.6 ± 11.9 | 21.7 ± 10.0 | 0.488 |
| Total bilirubin (mmol/L) | 16.5 ± 9.7 | 15.8 ± 9.0 | 0.508 |
| D-dimer (mg/L) | 0.3 ± 0.3 | 0.2 ± 0.3 | 0.339 |
| BNP (pg/mL) | 204.5 ± 191.2 | 220.9 ± 261.0 | 0.568 |
| High-sensitivity troponin I (hs-TnI) (ng/mL) | 0.1 ± 0.04 | 0.1 ± 0.06 | 0.291 |
| RBC count (×1012/L) | 4.6 ± 0.6 | 4.3 ± 0.6 | 0.150 |
| Haemoglobin (g/L) | 137.7 ± 18.6 | 134.4 ± 17.5 | 0.130 |
| Blood platelet count (×109/L) | 209.3 ± 58.9 | 196.8 ± 52.2 | 0.167 |
| Echocardiography measures | |||
| LA diameter (mm) | 46.7 ± 6.3 | 47.0 ± 6.6 | 0.115 |
| LVESD (mm) | 48.9 ± 6.1 | 49.3 ± 5.8 | 0.164 |
| LVEDD (mm) | 33.1 ± 6.9 | 32.9 ± 6.0 | 0.279 |
| LVEF (%) | 59.1 ± 8.7 | 60.7 ± 8.6 | 0.969 |
| Angioplasty guidewire-assisted group (n = 131) | Standard conventional group (n = 132) | P-value | |
|---|---|---|---|
| Clinical characteristics | |||
| Age (years) | 69.8 ± 8.3 | 68.1 ± 9.6 | 0.171 |
| Female, n (%) | 45 (34.4) | 43 (32.6) | 0.929 |
| Atrial fibrillation pattern | |||
| Paroxysmal, n (%) | 61 (46.6) | 54 (40.9) | 0.355 |
| Persistent or permanent, n (%) | 74 (56.5) | 81 (61.4) | 0.422 |
| Atrial fibrillation duration (months) | 17 (3.60) | 24 (6.72) | 0.670 |
| CHA2DS2-VASc score | 3.6 ± 1.4 | 3.7 ± 1.2 | 0.645 |
| HAS-BLED score | 2.5 ± 0.7 | 2.4 ± 0.6 | 0.211 |
| Concomitant diseases | |||
| Ischaemic stroke, n (%) | 80 (61.1) | 67 (50.8) | 0.092 |
| Haemorrhagic stroke, n (%) | 4 (3.1) | 9 (6.8) | 0.159 |
| Hypertension, n (%) | 94 (71.8) | 90 (68.2) | 0.527 |
| Diabetes mellitus, n (%) | 33 (25.2) | 28 (21.2) | 0.445 |
| Coronary artery disease, n (%) | 30 (22.9) | 25 (18.9) | 0.430 |
| Heart failure, n (%) | 8 (6.1) | 15 (11.4) | 0.131 |
| Laboratory examination | |||
| INR | 1.1 ± 0.3 | 1.2 ± 0.3 | 0.196 |
| Serum creatinine (mmol/L) | 80.5 ± 23.4 | 77.9 ± 26.2 | 0.398 |
| ALT (U/L) | 22.7 ± 10.6 | 23.3 ± 11.0 | 0.659 |
| AST (U/L) | 22.6 ± 11.9 | 21.7 ± 10.0 | 0.488 |
| Total bilirubin (mmol/L) | 16.5 ± 9.7 | 15.8 ± 9.0 | 0.508 |
| D-dimer (mg/L) | 0.3 ± 0.3 | 0.2 ± 0.3 | 0.339 |
| BNP (pg/mL) | 204.5 ± 191.2 | 220.9 ± 261.0 | 0.568 |
| High-sensitivity troponin I (hs-TnI) (ng/mL) | 0.1 ± 0.04 | 0.1 ± 0.06 | 0.291 |
| RBC count (×1012/L) | 4.6 ± 0.6 | 4.3 ± 0.6 | 0.150 |
| Haemoglobin (g/L) | 137.7 ± 18.6 | 134.4 ± 17.5 | 0.130 |
| Blood platelet count (×109/L) | 209.3 ± 58.9 | 196.8 ± 52.2 | 0.167 |
| Echocardiography measures | |||
| LA diameter (mm) | 46.7 ± 6.3 | 47.0 ± 6.6 | 0.115 |
| LVESD (mm) | 48.9 ± 6.1 | 49.3 ± 5.8 | 0.164 |
| LVEDD (mm) | 33.1 ± 6.9 | 32.9 ± 6.0 | 0.279 |
| LVEF (%) | 59.1 ± 8.7 | 60.7 ± 8.6 | 0.969 |
ALT, alanine aminotransferase; AST, aspartate aminotransferase; BNP, brain natriuretic peptide; INR, international normalized ratio; RBC, red blood cell; LA, left atrial; LVESD, left ventricular end-systolic diameter; LVEDD, left ventricular end-diastolic diameter; LVEF, left ventricular ejection fraction.
Baseline characteristics of patients
| Angioplasty guidewire-assisted group (n = 131) | Standard conventional group (n = 132) | P-value | |
|---|---|---|---|
| Clinical characteristics | |||
| Age (years) | 69.8 ± 8.3 | 68.1 ± 9.6 | 0.171 |
| Female, n (%) | 45 (34.4) | 43 (32.6) | 0.929 |
| Atrial fibrillation pattern | |||
| Paroxysmal, n (%) | 61 (46.6) | 54 (40.9) | 0.355 |
| Persistent or permanent, n (%) | 74 (56.5) | 81 (61.4) | 0.422 |
| Atrial fibrillation duration (months) | 17 (3.60) | 24 (6.72) | 0.670 |
| CHA2DS2-VASc score | 3.6 ± 1.4 | 3.7 ± 1.2 | 0.645 |
| HAS-BLED score | 2.5 ± 0.7 | 2.4 ± 0.6 | 0.211 |
| Concomitant diseases | |||
| Ischaemic stroke, n (%) | 80 (61.1) | 67 (50.8) | 0.092 |
| Haemorrhagic stroke, n (%) | 4 (3.1) | 9 (6.8) | 0.159 |
| Hypertension, n (%) | 94 (71.8) | 90 (68.2) | 0.527 |
| Diabetes mellitus, n (%) | 33 (25.2) | 28 (21.2) | 0.445 |
| Coronary artery disease, n (%) | 30 (22.9) | 25 (18.9) | 0.430 |
| Heart failure, n (%) | 8 (6.1) | 15 (11.4) | 0.131 |
| Laboratory examination | |||
| INR | 1.1 ± 0.3 | 1.2 ± 0.3 | 0.196 |
| Serum creatinine (mmol/L) | 80.5 ± 23.4 | 77.9 ± 26.2 | 0.398 |
| ALT (U/L) | 22.7 ± 10.6 | 23.3 ± 11.0 | 0.659 |
| AST (U/L) | 22.6 ± 11.9 | 21.7 ± 10.0 | 0.488 |
| Total bilirubin (mmol/L) | 16.5 ± 9.7 | 15.8 ± 9.0 | 0.508 |
| D-dimer (mg/L) | 0.3 ± 0.3 | 0.2 ± 0.3 | 0.339 |
| BNP (pg/mL) | 204.5 ± 191.2 | 220.9 ± 261.0 | 0.568 |
| High-sensitivity troponin I (hs-TnI) (ng/mL) | 0.1 ± 0.04 | 0.1 ± 0.06 | 0.291 |
| RBC count (×1012/L) | 4.6 ± 0.6 | 4.3 ± 0.6 | 0.150 |
| Haemoglobin (g/L) | 137.7 ± 18.6 | 134.4 ± 17.5 | 0.130 |
| Blood platelet count (×109/L) | 209.3 ± 58.9 | 196.8 ± 52.2 | 0.167 |
| Echocardiography measures | |||
| LA diameter (mm) | 46.7 ± 6.3 | 47.0 ± 6.6 | 0.115 |
| LVESD (mm) | 48.9 ± 6.1 | 49.3 ± 5.8 | 0.164 |
| LVEDD (mm) | 33.1 ± 6.9 | 32.9 ± 6.0 | 0.279 |
| LVEF (%) | 59.1 ± 8.7 | 60.7 ± 8.6 | 0.969 |
| Angioplasty guidewire-assisted group (n = 131) | Standard conventional group (n = 132) | P-value | |
|---|---|---|---|
| Clinical characteristics | |||
| Age (years) | 69.8 ± 8.3 | 68.1 ± 9.6 | 0.171 |
| Female, n (%) | 45 (34.4) | 43 (32.6) | 0.929 |
| Atrial fibrillation pattern | |||
| Paroxysmal, n (%) | 61 (46.6) | 54 (40.9) | 0.355 |
| Persistent or permanent, n (%) | 74 (56.5) | 81 (61.4) | 0.422 |
| Atrial fibrillation duration (months) | 17 (3.60) | 24 (6.72) | 0.670 |
| CHA2DS2-VASc score | 3.6 ± 1.4 | 3.7 ± 1.2 | 0.645 |
| HAS-BLED score | 2.5 ± 0.7 | 2.4 ± 0.6 | 0.211 |
| Concomitant diseases | |||
| Ischaemic stroke, n (%) | 80 (61.1) | 67 (50.8) | 0.092 |
| Haemorrhagic stroke, n (%) | 4 (3.1) | 9 (6.8) | 0.159 |
| Hypertension, n (%) | 94 (71.8) | 90 (68.2) | 0.527 |
| Diabetes mellitus, n (%) | 33 (25.2) | 28 (21.2) | 0.445 |
| Coronary artery disease, n (%) | 30 (22.9) | 25 (18.9) | 0.430 |
| Heart failure, n (%) | 8 (6.1) | 15 (11.4) | 0.131 |
| Laboratory examination | |||
| INR | 1.1 ± 0.3 | 1.2 ± 0.3 | 0.196 |
| Serum creatinine (mmol/L) | 80.5 ± 23.4 | 77.9 ± 26.2 | 0.398 |
| ALT (U/L) | 22.7 ± 10.6 | 23.3 ± 11.0 | 0.659 |
| AST (U/L) | 22.6 ± 11.9 | 21.7 ± 10.0 | 0.488 |
| Total bilirubin (mmol/L) | 16.5 ± 9.7 | 15.8 ± 9.0 | 0.508 |
| D-dimer (mg/L) | 0.3 ± 0.3 | 0.2 ± 0.3 | 0.339 |
| BNP (pg/mL) | 204.5 ± 191.2 | 220.9 ± 261.0 | 0.568 |
| High-sensitivity troponin I (hs-TnI) (ng/mL) | 0.1 ± 0.04 | 0.1 ± 0.06 | 0.291 |
| RBC count (×1012/L) | 4.6 ± 0.6 | 4.3 ± 0.6 | 0.150 |
| Haemoglobin (g/L) | 137.7 ± 18.6 | 134.4 ± 17.5 | 0.130 |
| Blood platelet count (×109/L) | 209.3 ± 58.9 | 196.8 ± 52.2 | 0.167 |
| Echocardiography measures | |||
| LA diameter (mm) | 46.7 ± 6.3 | 47.0 ± 6.6 | 0.115 |
| LVESD (mm) | 48.9 ± 6.1 | 49.3 ± 5.8 | 0.164 |
| LVEDD (mm) | 33.1 ± 6.9 | 32.9 ± 6.0 | 0.279 |
| LVEF (%) | 59.1 ± 8.7 | 60.7 ± 8.6 | 0.969 |
ALT, alanine aminotransferase; AST, aspartate aminotransferase; BNP, brain natriuretic peptide; INR, international normalized ratio; RBC, red blood cell; LA, left atrial; LVESD, left ventricular end-systolic diameter; LVEDD, left ventricular end-diastolic diameter; LVEF, left ventricular ejection fraction.
Primary outcome and efficiency
The procedural parameters are summarized in Table 3. All patients in the guidewire-assisted TSP group underwent successful TSP. Five patients in the standard conventional group initially underwent unsuccessful TSP; they then completed successful puncture after switching to the guidewire-assisted approach (details in Supplementary material online, Table S1). The one-time success rate of TSP was significantly higher in the guidewire-assisted TSP group than in the standard conventional group (92.4 vs. 77.3%, P = 0.001). The total TSP procedure time was significantly shorter for the guidewire-assisted TSP group than for the standard conventional group (109.2 ± 48.2 vs. 120.5 ± 57.6 s, P = 0.023). Unlike the standard conventional group, which required a contrast agent during the TSP procedure, the contrast dose in the guidewire-assisted TSP group was near to zero (P < 0.001). Guidewire-assisted puncture tended to obtain higher rates of good coaxial orientation of the sheath with the LAA (66.4 vs. 54.5%, P = 0.059). There was no significant difference in the failure rate of the assigned TSP type or in the total radiation dose or contrast dose used during the LAAO procedure between the two groups (all P > 0.05).
Procedural success, efficiency, and safety outcomes
| Angioplasty guidewire-assisted group (n = 131) | Standard conventional group (n = 132) | P-value | |
|---|---|---|---|
| Primary outcome | |||
| One-time success of TSP, n (%) | 121 (92.4) | 102 (77.3) | 0.001 |
| Secondary outcomes | |||
| Total procedure time of TSP (s) | 109.2 ± 48.2 | 120.5 ± 57.6 | 0.023 |
| Time from sheath in SVC to sheath in fossa ovalis (s) | 17.1 ± 13.8 | 18.3 ± 19.2 | 0.549 |
| Time from needle in fossa ovalis to needle in left atrium (s) | 51.3 ± 30.5 | 61.8 ± 41.7 | 0.011 |
| Time from needle in left atrium to sheath in left atrium (s) | 40.8 ± 32.5 | 40.4 ± 28.9 | 0.917 |
| Failure rate of the assigned TSP type, n (%) | 0 (0) | 5 (3.8) | 0.06 |
| Volume of contrast agent during TSP (mL) | 0.00 ± 0.0 | 1.4 ± 0.8 | <0.001 |
| Volume of contrast agent during LAAO (mL) | 61.9 ± 32.3 | 67.9 ± 30.8 | 0.121 |
| Radiation exposure dose (mGy) | 628.1 ± 165.4 | 642.4 ± 140.6 | 0.604 |
| Procedural efficiency during LAAO | |||
| Direction of sheath was well coaxial with the ostium of LAA | |||
| Good direction, n (%) | 87 (66.4) | 72 (54.5) | 0.059 |
| Total successful implantation of LAAO, n (%) | 131 (100) | 132 (100) | — |
| Successful LAAO implantation at the first attempt, n (%) | 92 (70.2) | 86 (65.2) | 0.429 |
| TSP-related complications | |||
| Total TSP-related complications, n (%) | 0 (0) | 2 (1.5) | 0.498 |
| Pericardial effusion, n (%) | 0 (0) | 1 (0.8) | 1.000 |
| Cardiac tamponade, n (%) | 0 (0) | 0 (0) | — |
| Misdirected puncture to other structures, n (%) | 0 (0) | 2 (1.5) | 0.498 |
| Aorta, n (%) | 0 (0) | 1 (0.8) | 1.000 |
| Left atrial posterolateral wall, n (%) | 0 (0) | 1 (0.8) | 1.000 |
| Left atrial roof, n (%) | 0 (0) | 0 (0) | — |
| Other structures, n (%) | 0 (0) | 0 (0) | — |
| Thrombosis or air embolus, n (%) | 0 (0) | 0 (0) | — |
| Cardiovascular or sudden death, n (%) | 0 (0) | 0 (0) | — |
| Death from other cause, n (%) | 0 (0) | 0 (0) | — |
| LAAO-related complications | |||
| Total LAAO-related complications, n (%) | 6 (4.6) | 5 (3.8) | 0.769 |
| Pericardial effusion, n (%) | 1 (0.8) | 2 (1.5) | 1.000 |
| Cardiac tamponade, n (%) | 0 (0) | 0 (0) | — |
| Major bleeding, n (%) | 0 (0) | 0 (0) | — |
| Haematoma at puncture site, n (%) | 4 (3.1) | 3 (2.3) | 0.722 |
| Thrombosis or air embolus, n (%) | 1 (0.8) | 0 (0) | 0.498 |
| Cardiovascular or sudden death, n (%) | 0 (0) | 0 (0) | — |
| Death from other cause, n (%) | 0 (0) | 0 (0) | — |
| Angioplasty guidewire-assisted group (n = 131) | Standard conventional group (n = 132) | P-value | |
|---|---|---|---|
| Primary outcome | |||
| One-time success of TSP, n (%) | 121 (92.4) | 102 (77.3) | 0.001 |
| Secondary outcomes | |||
| Total procedure time of TSP (s) | 109.2 ± 48.2 | 120.5 ± 57.6 | 0.023 |
| Time from sheath in SVC to sheath in fossa ovalis (s) | 17.1 ± 13.8 | 18.3 ± 19.2 | 0.549 |
| Time from needle in fossa ovalis to needle in left atrium (s) | 51.3 ± 30.5 | 61.8 ± 41.7 | 0.011 |
| Time from needle in left atrium to sheath in left atrium (s) | 40.8 ± 32.5 | 40.4 ± 28.9 | 0.917 |
| Failure rate of the assigned TSP type, n (%) | 0 (0) | 5 (3.8) | 0.06 |
| Volume of contrast agent during TSP (mL) | 0.00 ± 0.0 | 1.4 ± 0.8 | <0.001 |
| Volume of contrast agent during LAAO (mL) | 61.9 ± 32.3 | 67.9 ± 30.8 | 0.121 |
| Radiation exposure dose (mGy) | 628.1 ± 165.4 | 642.4 ± 140.6 | 0.604 |
| Procedural efficiency during LAAO | |||
| Direction of sheath was well coaxial with the ostium of LAA | |||
| Good direction, n (%) | 87 (66.4) | 72 (54.5) | 0.059 |
| Total successful implantation of LAAO, n (%) | 131 (100) | 132 (100) | — |
| Successful LAAO implantation at the first attempt, n (%) | 92 (70.2) | 86 (65.2) | 0.429 |
| TSP-related complications | |||
| Total TSP-related complications, n (%) | 0 (0) | 2 (1.5) | 0.498 |
| Pericardial effusion, n (%) | 0 (0) | 1 (0.8) | 1.000 |
| Cardiac tamponade, n (%) | 0 (0) | 0 (0) | — |
| Misdirected puncture to other structures, n (%) | 0 (0) | 2 (1.5) | 0.498 |
| Aorta, n (%) | 0 (0) | 1 (0.8) | 1.000 |
| Left atrial posterolateral wall, n (%) | 0 (0) | 1 (0.8) | 1.000 |
| Left atrial roof, n (%) | 0 (0) | 0 (0) | — |
| Other structures, n (%) | 0 (0) | 0 (0) | — |
| Thrombosis or air embolus, n (%) | 0 (0) | 0 (0) | — |
| Cardiovascular or sudden death, n (%) | 0 (0) | 0 (0) | — |
| Death from other cause, n (%) | 0 (0) | 0 (0) | — |
| LAAO-related complications | |||
| Total LAAO-related complications, n (%) | 6 (4.6) | 5 (3.8) | 0.769 |
| Pericardial effusion, n (%) | 1 (0.8) | 2 (1.5) | 1.000 |
| Cardiac tamponade, n (%) | 0 (0) | 0 (0) | — |
| Major bleeding, n (%) | 0 (0) | 0 (0) | — |
| Haematoma at puncture site, n (%) | 4 (3.1) | 3 (2.3) | 0.722 |
| Thrombosis or air embolus, n (%) | 1 (0.8) | 0 (0) | 0.498 |
| Cardiovascular or sudden death, n (%) | 0 (0) | 0 (0) | — |
| Death from other cause, n (%) | 0 (0) | 0 (0) | — |
LAA, left atrial appendage; LAAO, LAA occlusion; SVC, superior vena cava; TSP, transseptal puncture.
Procedural success, efficiency, and safety outcomes
| Angioplasty guidewire-assisted group (n = 131) | Standard conventional group (n = 132) | P-value | |
|---|---|---|---|
| Primary outcome | |||
| One-time success of TSP, n (%) | 121 (92.4) | 102 (77.3) | 0.001 |
| Secondary outcomes | |||
| Total procedure time of TSP (s) | 109.2 ± 48.2 | 120.5 ± 57.6 | 0.023 |
| Time from sheath in SVC to sheath in fossa ovalis (s) | 17.1 ± 13.8 | 18.3 ± 19.2 | 0.549 |
| Time from needle in fossa ovalis to needle in left atrium (s) | 51.3 ± 30.5 | 61.8 ± 41.7 | 0.011 |
| Time from needle in left atrium to sheath in left atrium (s) | 40.8 ± 32.5 | 40.4 ± 28.9 | 0.917 |
| Failure rate of the assigned TSP type, n (%) | 0 (0) | 5 (3.8) | 0.06 |
| Volume of contrast agent during TSP (mL) | 0.00 ± 0.0 | 1.4 ± 0.8 | <0.001 |
| Volume of contrast agent during LAAO (mL) | 61.9 ± 32.3 | 67.9 ± 30.8 | 0.121 |
| Radiation exposure dose (mGy) | 628.1 ± 165.4 | 642.4 ± 140.6 | 0.604 |
| Procedural efficiency during LAAO | |||
| Direction of sheath was well coaxial with the ostium of LAA | |||
| Good direction, n (%) | 87 (66.4) | 72 (54.5) | 0.059 |
| Total successful implantation of LAAO, n (%) | 131 (100) | 132 (100) | — |
| Successful LAAO implantation at the first attempt, n (%) | 92 (70.2) | 86 (65.2) | 0.429 |
| TSP-related complications | |||
| Total TSP-related complications, n (%) | 0 (0) | 2 (1.5) | 0.498 |
| Pericardial effusion, n (%) | 0 (0) | 1 (0.8) | 1.000 |
| Cardiac tamponade, n (%) | 0 (0) | 0 (0) | — |
| Misdirected puncture to other structures, n (%) | 0 (0) | 2 (1.5) | 0.498 |
| Aorta, n (%) | 0 (0) | 1 (0.8) | 1.000 |
| Left atrial posterolateral wall, n (%) | 0 (0) | 1 (0.8) | 1.000 |
| Left atrial roof, n (%) | 0 (0) | 0 (0) | — |
| Other structures, n (%) | 0 (0) | 0 (0) | — |
| Thrombosis or air embolus, n (%) | 0 (0) | 0 (0) | — |
| Cardiovascular or sudden death, n (%) | 0 (0) | 0 (0) | — |
| Death from other cause, n (%) | 0 (0) | 0 (0) | — |
| LAAO-related complications | |||
| Total LAAO-related complications, n (%) | 6 (4.6) | 5 (3.8) | 0.769 |
| Pericardial effusion, n (%) | 1 (0.8) | 2 (1.5) | 1.000 |
| Cardiac tamponade, n (%) | 0 (0) | 0 (0) | — |
| Major bleeding, n (%) | 0 (0) | 0 (0) | — |
| Haematoma at puncture site, n (%) | 4 (3.1) | 3 (2.3) | 0.722 |
| Thrombosis or air embolus, n (%) | 1 (0.8) | 0 (0) | 0.498 |
| Cardiovascular or sudden death, n (%) | 0 (0) | 0 (0) | — |
| Death from other cause, n (%) | 0 (0) | 0 (0) | — |
| Angioplasty guidewire-assisted group (n = 131) | Standard conventional group (n = 132) | P-value | |
|---|---|---|---|
| Primary outcome | |||
| One-time success of TSP, n (%) | 121 (92.4) | 102 (77.3) | 0.001 |
| Secondary outcomes | |||
| Total procedure time of TSP (s) | 109.2 ± 48.2 | 120.5 ± 57.6 | 0.023 |
| Time from sheath in SVC to sheath in fossa ovalis (s) | 17.1 ± 13.8 | 18.3 ± 19.2 | 0.549 |
| Time from needle in fossa ovalis to needle in left atrium (s) | 51.3 ± 30.5 | 61.8 ± 41.7 | 0.011 |
| Time from needle in left atrium to sheath in left atrium (s) | 40.8 ± 32.5 | 40.4 ± 28.9 | 0.917 |
| Failure rate of the assigned TSP type, n (%) | 0 (0) | 5 (3.8) | 0.06 |
| Volume of contrast agent during TSP (mL) | 0.00 ± 0.0 | 1.4 ± 0.8 | <0.001 |
| Volume of contrast agent during LAAO (mL) | 61.9 ± 32.3 | 67.9 ± 30.8 | 0.121 |
| Radiation exposure dose (mGy) | 628.1 ± 165.4 | 642.4 ± 140.6 | 0.604 |
| Procedural efficiency during LAAO | |||
| Direction of sheath was well coaxial with the ostium of LAA | |||
| Good direction, n (%) | 87 (66.4) | 72 (54.5) | 0.059 |
| Total successful implantation of LAAO, n (%) | 131 (100) | 132 (100) | — |
| Successful LAAO implantation at the first attempt, n (%) | 92 (70.2) | 86 (65.2) | 0.429 |
| TSP-related complications | |||
| Total TSP-related complications, n (%) | 0 (0) | 2 (1.5) | 0.498 |
| Pericardial effusion, n (%) | 0 (0) | 1 (0.8) | 1.000 |
| Cardiac tamponade, n (%) | 0 (0) | 0 (0) | — |
| Misdirected puncture to other structures, n (%) | 0 (0) | 2 (1.5) | 0.498 |
| Aorta, n (%) | 0 (0) | 1 (0.8) | 1.000 |
| Left atrial posterolateral wall, n (%) | 0 (0) | 1 (0.8) | 1.000 |
| Left atrial roof, n (%) | 0 (0) | 0 (0) | — |
| Other structures, n (%) | 0 (0) | 0 (0) | — |
| Thrombosis or air embolus, n (%) | 0 (0) | 0 (0) | — |
| Cardiovascular or sudden death, n (%) | 0 (0) | 0 (0) | — |
| Death from other cause, n (%) | 0 (0) | 0 (0) | — |
| LAAO-related complications | |||
| Total LAAO-related complications, n (%) | 6 (4.6) | 5 (3.8) | 0.769 |
| Pericardial effusion, n (%) | 1 (0.8) | 2 (1.5) | 1.000 |
| Cardiac tamponade, n (%) | 0 (0) | 0 (0) | — |
| Major bleeding, n (%) | 0 (0) | 0 (0) | — |
| Haematoma at puncture site, n (%) | 4 (3.1) | 3 (2.3) | 0.722 |
| Thrombosis or air embolus, n (%) | 1 (0.8) | 0 (0) | 0.498 |
| Cardiovascular or sudden death, n (%) | 0 (0) | 0 (0) | — |
| Death from other cause, n (%) | 0 (0) | 0 (0) | — |
LAA, left atrial appendage; LAAO, LAA occlusion; SVC, superior vena cava; TSP, transseptal puncture.
Safety outcomes
Transseptal puncture–related complications
As shown in Table 3, no TSP-related complications occurred in the guidewire-assisted TSP group. However, two complications occurred in the conventional group: one was a misdirected puncture to the aorta after several puncture attempts for which no further treatment was required, and the other was a misdirected puncture to the atrial posterior wall in a case of atrial septal aneurysm, which resulted in delayed-onset pericardial effusion requiring pericardiocentesis. There was no significant difference in the TSP-related complication rate between the two groups (all P > 0.05).
Left atrial appendage occlusion–related complications
Four patients in the guidewire-assisted TSP group and three in the standard conventional group developed a femoral vein puncture-related haematoma (Table 3). One patient in the guidewire-assisted TSP group and two in the standard conventional group developed pericardial effusion that was unrelated to the atrial septal puncture procedure. One patient in the guidewire-assisted TSP group developed an air embolus during the procedure, which was also not induced by the mechanical puncture. There was no significant difference in any of the LAAO-related complications between the two groups (all P > 0.05).
Guidewire-assisted transseptal puncture approach in patients with complex atrial septal anatomy
In the standard conventional group, five patients underwent conversion to the guidewire-assisted puncture approach because of unsuccessful puncture in the difficult cases [i.e. atrial septal aneurysm (Figure 4; see Supplementary material online, Video S2) or an abnormal hypertrophic atrial septum (Figure 5)]. However, no patients in the guidewire-assisted TSP group were switched to the conventional group. All patients with complex atrial septal anatomy in the guidewire-assisted TSP group underwent successful TSP and acquired good coaxial orientation of the sheath with the LAA.
Angioplasty guidewire-assisted transseptal puncture in a patient with an atrial septal aneurysm. (A) Transthoracic echocardiographic image of an atrial septal aneurysm in a patient with atrial fibrillation before the LAAO procedure. (B1–B9) Angioplasty guidewire-assisted transseptal puncture in the setting of an atrial septal aneurysm for the LAAO procedure. BRK, Brockenbrough; GW, guidewire; LA, left atrium; LAAO, left atrial appendage occlusion; RA, right atrium.
Angioplasty guidewire-assisted transseptal puncture in a patient with a hypertrophic atrial septum. (A) Transthoracic echocardiographic image of a hypertrophic atrial septum in a patient with atrial fibrillation before the LAAO procedure. (B1–B9) Angioplasty guidewire-assisted transseptal puncture in the setting of an abnormal hypertrophic atrial septum during the LAAO procedure. BRK, Brockenbrough; GW, guidewire; IVC, inferior vena cava; LA, left atrium; LAAO, left atrial appendage occlusion; RA, right atrium; SVC, superior vena cava.
Discussion
This multicentre randomized trial demonstrated the efficiency and safety of a novel angioplasty guidewire-assisted TSP method, known as the ATP technique, performed during the LAAO procedure. The ATP technique achieved a significantly higher one-time TSP success rate, shortened the TSP procedure, and resulted in a higher rate of good coaxial orientation of the LAAO sheath. All patients in the guidewire-assisted TSP group underwent successful TSP, whereas five in the standard conventional group were switched to the guidewire-assisted approach. No patients in the guidewire-assisted TSP group developed TSP-related procedural complications. The ATP method had a high success rate in difficult cases (i.e. an aneurysmal or hypertrophic/fibrotic atrial septum).
Transseptal puncture carries a low, albeit real, risk of cardiac perforation posteriorly to the LA or anteriorly to the ascending aorta.14,15 The incidence of cardiac perforation during TSP is ∼1%.16,17 Inadvertent puncturing of adjacent structures may occur because of the misdirected setting of the orientation of the needle or the sliding of the needle at the time of TSP. The probability of accidental puncture may be increased in patients with difficult atrial septal anatomy.18,19 During conventional TSP, the BRK needle is advanced through the dilator tip to create a tent in the septum at the time of introducing the puncture. In difficult cases with complex atrial septal anatomy (i.e. an atrial septal aneurysm or a hypertrophic or a fibrotic atrial septum), the entire needle/dilator–sheath assembly needs to be advanced further, resulting in severe tenting of the inter-atrial septum and high pressure of the needle tip on the septum to achieve puncture. When such additional force is applied to the assembly, the needle or the entire dilator–sheath assembly lurches forward at the moment of puncture, increasing the risk of perforation of the LA posterior wall or aorta. Unlike conventional TSP, the novel ATP technique creates a sieve mesh structure at the puncture point by piercing the inter-atrial septum multiple times using the stiff end of the guidewire. The puncture needle is delivered to the LA along the stiff end of the angioplasty guidewire through the sieve mesh structure with little breakthrough resistance. Therefore, this novel and simple technology reduces the incidence of misdirected puncture during TSP and makes the procedure safer.
In the guidewire-assisted TSP group, additional use of the angioplasty guidewire facilitated successful TSP, especially in patients with a resistant FO. Compared with the conventional BRK needle method, the angioplasty guidewire-assisted method resulted in a relatively shorter duration for transseptal LA access. The advantages of using a 0.014″ angioplasty guidewire to assist with the TSP procedure are as follows: (i) the puncture site can be precisely located, and needle slide is limited by the stiff tip of the guidewire tail before breaking through the FO; (ii) tending pressure of the atrial septum can be decreased to avoid inadvertent injury to the surrounding structures by the BRK needle through repeated puncture of the FO with the stiff tip of the guidewire to form a sieve mesh structure; (iii) a successful puncture can be identified without the need for contrast injection by using the soft tip of the angioplasty guidewire head, which is easily advanced to the LSPV after entering the LA; (iv) the risks of perforation of the aortic root/posterior wall of the LA are reduced when the needle or the entire assembly advances along the guidewire; and (v) the LSPV is marked with the angioplasty guidewire, allowing other devices to be easily advanced into the LA or LSPV.
Abnormal atrial septal anatomy makes it challenging for interventional physicians to perform TSP. For example, an atrial septal aneurysm is the presence of redundant and mobilizable septal tissue in the region of the FO with bulging into the right atrium or LA.20,21 The sheath and BRK needle may advance too far into the LA because of the loose and mobilizable tissue of the atrial septum, which increases the risk of inadvertent puncture of adjacent tissues. Moreover, even if LA puncture is successful, the site may not be optimal. The appropriate puncture site for the LAAO procedure can achieve better coaxiality of the sheath with the ostium of the LAA, which is essential for successful implantation. Other abnormalities of the atrial septum, such as a hypertrophic, scarred, or fibrotic atrial septum, as well as the presence of a previously implanted atrial septal defect occluder device, present similar challenges. The novel ATP technique has more advantages than the standard conventional method because of the toughness of the stiff tail of the angioplasty guidewire, which relies less on tight contact between the puncture device and the atrial septum.
Many clinical solutions to difficult TSP are available, such as using a radiofrequency catheter, an electrotome, and a laser to emit energy at the site where the puncture needle is positioned, as well as puncturing the atrial septal structure at the positioned site, thereby permitting smooth passage of the puncture needle through the inter-atrial septum.22–28 These procedures are important supplements to the conventional TSP approaches and can further improve the safety of the TSP procedure in complex cases, although the cost can be an issue.22–28 Eichenlaub et al.29 performed electroanatomic three-dimensional mapping of the right atrium to identify the FO during the preparation for TSP and demonstrated that mapping before TSP was a simple technique for the identification of the FO and radiation-free performance of TSP, especially in patients who consented to undergo ablation procedures for atrial fibrillation. The angioplasty guidewire is a common consumable in interventional surgeries. Nearly all interventional centres are routinely equipped with such guidewires, and cardiologists performing interventional procedures are very familiar with the use of this device. Therefore, the angioplasty guidewire-assisted method for puncture of inter-atrial septa with complex structures is easier to replicate and popularize and is more affordable and effective.
This study had some limitations. First, it was a randomized controlled trial with a relatively small sample size. Larger scale randomized trials are necessary to confirm the robustness of our findings. Furthermore, the safety, performance, and usability of the angioplasty guidewire-assisted TSP technique were confirmed only for the LAAO procedure in this multicentre randomized trial. The safety and efficiency of this technique in other interventional therapies that require access into the LA (e.g. ablation of left-sided accessory pathways, ablation of atrial fibrillation, percutaneous mitral valvuloplasty, or percutaneous mitral valve repair) still need to be confirmed by further studies.
Conclusions
This multicentre randomized trial demonstrated the efficiency and safety of an angioplasty guidewire-assisted TSP technique for the LAAO procedure. This novel technique has the potential for application in all interventional therapies requiring TSP.
Supplementary material
Supplementary material is available at Europace online.
Funding
This work was supported by the Shanghai Municipal Education Commission (SHSMU-ZDCX20210700), the Science and Technology Commission of Shanghai Municipality Professional Technical Service Platform (22DZ2292400), the Shanghai Municipal Health Commission Public Health Key Discipline Construction Project (GWVI-11.1-26), and the Top Priority Research Center (2023ZZ02021), the Shanghai Municipal Health Commission (2022JC013), and the Shanghai Hospital Development Center (SHDC12022102).
Data availability
The data underlying this article will be shared on reasonable request to the corresponding author.
References
Author notes
Feng Hu, Bin Xu, Zhiqing Qiao and Jun Pu contributed equally to this work.
Conflict of interest: None declared.
