Safety and Efficacy of Single Femoral Vein Puncture Technique for Double Access in Patent Foramen Ovale Closure Under ICE Guidance—A Single Center Experience of the “Two‐In‐One Technique”

ABSTRACT

Background

In selected patient populations, percutaneous closure of patent foramen ovale has been shown to be beneficial in preventing cerebral ischaemic events. In most cases, this procedure requires echocardiographic guidance, which may be transesophageal, transthoracic or intracardiac. Intracardiac echocardiography (ICE) has the advantage of not requiring general anaesthesia but usually requires a second vascular access.

Aims

The aim of this study was to evaluate the safety and efficacy of the single femoral vein puncture technique for double veinous access compared to conventional bilateral double puncture during patent foramen ovale (PFO) closure under intracardiac echocardiography (ICE) guidance.

Methods

A retrospective study including all patients who underwent PFO closure under ICE guidance between January 2018 and April 2024 in University Hospital of Dijon, comparing the single puncture technique, defined as a single vascular hole for two sheaths, with those who underwent bilateral puncture. We collected baseline patient characteristics as well as intra‐ and post‐procedural data, especially significant vascular complications (bleeding, false aneurysm, deep vein thrombosis, arteriovenous fistula) and procedural success (defined as successful placement of the prosthesis, meeting stability criteria, without embolization). In addition, patients were asked to rate the comfort of the procedure on a scale of 0 to 10 after the procedure.

Results

We analyzed 179 consecutive patients, of whom 126 received a femoral vein approach using the two‐in‐one technique and 53 received a bilateral femoral vein puncture. PFO closure was successful in all cases regardless of group. No tamponade, device migration, or death was observed during hospitalization. Vascular complication rate was comparable (3 (1.6%) vs. 2 (3.8%); p = 0.582). In addition, the single puncture technique was associated with an increased comfort score compared with the bilateral puncture technique (9.20 ± 1.55 vs. 8.44 ± 1.93; p = 0.044), shorter procedure time (40 min [32; 50] vs. 60 min [48; 70]; p < 0.001), hospital stay duration (0.82 ± 1.02 days vs. 2.04 ± 0.83 days; p < 0.001) and fluoroscopy time (5.71 min [4.28; 8.33] vs. 9.57 min [7.42; 13.11]; p < 0.001).

Conclusion

The single femoral vein puncture technique for double femoral vein access is safe and effective for PFO closure under ICE guidance. It is also associated with increased patient comfort and reduced fluoroscopy time, although large multicenter studies are needed to confirm these results.

1. Introduction

The patent foramen ovale is a physiological bypass between the right and left atria of the heart that is normally present in the fetus and allows oxygenated blood from the placenta to pass directly into the systemic circulation. After birth, this connection closes naturally in most cases during the first 2 years of life. However, in about 25% of adults, the foramen ovale remains patent [1]. A condition that is generally asymptomatic but can be associated with a variety of clinical complications [2]. Patent foramen ovale (PFO) closure is an interventional cardiology procedure that has been shown to be beneficial in several conditions. such as cryptogenic stroke [3, 4, 5, 6, 7], non‐cerebral paradoxical embolism [8] and hypoxia due to right‐to‐left shunting, sometimes manifested by platypnea–orthodeoxia syndrome. Decompression accidents are a rare indication [9, 10], and migraine with aura is not one at present [11].

Closure of the PFO is a procedure performed in expert centers, requiring optimum precision to guarantee an effective result and minimize complications. Ultrasound guidance plays a critical role throughout the procedure, providing real‐time visualization of cardiac structures, allowing precise assessment of PFO anatomy and device position.

Transesophageal echocardiography (TEE) is the reference method for guiding PFO closure. This technique requires general anesthesia and is particularly valuable in confirming correct positioning and anchoring of the device and the absence of immediate complications such as embolization or pericardial effusion.

In order to avoid the need for general anesthesia, certain guidance techniques have been developed, such as micro‐TEE, transthoracic ultrasound guidance, fluoroscopic implantation alone and intracardiac ultrasound (ICE) [12, 13]. Unlike TTE and micro‐TEE, ICE have the advantage of not requiring an interventional echocardiographer to perform the procedure, and offers the same implant safety as these techniques, which is sometimes more difficult to achieve with fluoroscopy alone. However, its use requires a learning curve and is limited by the cost of consumables, in the absence of authorization to resterilize ICE probes in France.

Technically, the use of ICE requires a second femoral puncture for the probe, which is usually performed contralaterally. However, there is an alternative puncture technique that allows two sheaths to be inserted after a single venous puncture, first described by Morita et al. for adrenal venous sampling [14]. There are two intuitive hypotheses: limiting the number of vascular punctures will reduce the number of vascular complications or, conversely, using a larger vascular access will increase them. Therefore, we aimed to compare the safety and efficacy of the single femoral venous puncture technique for dual access, also known as the “two‐in‐one” technique, with the two‐puncture technique to achieve ICE‐guided PFO closure.

The third technique, consisting of two separate punctures in the same femoral vein was not evaluated in this study.

2. Procedure and Puncture Technique

2.1. PFO Closure

All procedures were performed under local anesthesia with ICE guidance with the ViewFlex Xtra ICE 9‐F catheter (Abbott Cardiovascular) inserted through a 10F introducer sheath and the ViewMate Ultrasound Zonare console (Abbott Cardiovascular).

After femoral access was obtained using one of the techniques studied, heparin was administered to achieve an Activated Clotting Time >250 s as recommended [2], then the PFO was crossed using a 0.035" guidewire and a multipurpose catheter. The guidewire was advanced into the left upper pulmonary vein and the delivery sheath was advanced over the wire. After removal of the dilator, the device was advanced within the delivery sheath, the left disc opened in the left atrium, brought into contact with the septum and the delivery sheath retracted to open the right disc in the right atrium. After echocardiographic verification of correct device position and stability maneuvers, the device was released.

The devices used in the study were double umbrella devices such as the AMPLATZER PFO OCCLUDER (Abbott Cardiovascular), AMPLATZER SEPTAL OCCLUDER CRIBRIFORM (Abbott Cardiovascular), and ULTRASEPT (Cardia Inc.). The choice and size of the devices was left to the discretion of the trained operator according to intracardiac echocardiographic data and stability maneuvers.

Dual antiplatelet therapy with aspirin and clopidogrel was continued for 3 to 6 months after the procedure, after which clopidogrel was discontinued unless otherwise indicated.

2.2. Puncture Technique

The two‐in‐one puncture technique (Figure 1) consists of ultrasound‐guided puncture of the common femoral vein, a small skin scalpel incision, preclosure with a suture‐based vascular closure device, insertion of a first introducer sheath followed by two 0.035" guidewires, removal of the introducer sheath, and insertion of the various introducers required for the procedure on each 0.035" guidewire, that is, in this case, 10F introducer sheath for the ICE probe and 8 or 9F for the device delivery sheath. If preclosure fails, a second suture‐based vessel closure device can be placed, or mechanical compression alone can be used.

Figure 1.

Main steps of the two‐in‐one technique applied to ICE‐guided PFO closure. (A) Single femoral venous puncture. (B) Preclosure with suture‐based vessel closure device (Perclose ProStyle System (Abbott Vascular Inc., United States)). (C) Double 0.035" wiring of the introducer sheath. (D) Insertion of the two introducers. (E) ICE‐guided device positioning. [Color figure can be viewed at wileyonlinelibrary.com]

3. Methods

3.1. Study Design and Patients

Adult patients who underwent ICE‐guided PFO closure at the University Hospital of Dijon (France) between January 2018 and April 2024 were screened for inclusion in this retrospective study.

Inclusion criteria were patient age ≥18 years, ICE‐guided PFO closure for cryptogenic stroke or TIA.

Noninclusion criteria were TEE‐guided implantation, general anesthesia, PFO closure for platypnea–orthodeoxia syndrome or decompression disease.

In our center, PFO closure under ICE guidance started in 2018 and all procedures were performed by multiple teams of experienced interventional cardiologists. The single vein puncture technique was gradually developed, with some interventional teams using this technique as the first approach, while others continued to use the two punctures as the default technique. The two groups were therefore formed according to the femoral access technique used, which was left to the habits of the different interventional teams of experienced operators.

3.2. Data Collection

All data were extracted from electronical medical files of the University Hospital of Dijon. The following baseline patient characteristics were collected: demographics (age, sex), cardiovascular risk factors (smoking, hypertension, overweight, diabetes, dyslipidemia), comorbidities (previous stroke, MI, DVT or PE, migraine), and medications such as estrogen–progestin contraceptives. We also collected data on the type of qualifying event (stroke or TIA), NIHSS score, RoPE score, CHADS‐VASC (calculated including the stroke event), and echocardiographic parameters.

During the in‐hospital period, the following safety criteria were collected: periprocedural complications, including access‐related complications (bleeding, false aneurysm, deep vein thrombosis, arteriovenous fistula), pericardial effusion requiring drainage, device migration, and supraventricular tachycardia, vital status. After the procedure, the patient is asked by the nursing team in the postoperative monitoring room to rate their comfort using a non‐validated scale from 0 to 10.

3.3. Outcomes Definition

Procedural success was defined as successful placement of the prosthesis, meeting stability criteria, without embolization. The persistence of a moderate shunt per procedure was not considered a procedural failure, as correction was possible after endothelialization of the device. Vascular complications included bleeding, the severity of which was graded according to the Bleeding Academic Research Consortium (BARC) classification [15], false aneurysm, deep vein thrombosis and arteriovenous fistula. Doppler ultrasound was only performed if there were clinical findings on the predischarge examination. Patient comfort was assessed by asking patients to rate their comfort from 0 (unbearable) to 10 (no discomfort) after the procedure by the nurse in charge of the patient. Early migration or pericardial effusion was systematically checked on predischarge echocardiography. Supraventricular arrhythmias were detected during intraprocedural monitoring, on the discharge electrocardiogram, or in the presence of symptoms.

3.4. Statistical Analysis

Continuous variables were expressed as mean ± SD or median with interquartile range (IQR) and compared using unpaired Student's t‐test or nonparametric Mann–Whitney U test, respectively. Normality of distribution of continuous variables was analyzed using the Kolmogorov–Smirnov test. Categorical variables were reported as absolute numbers and percentages and compared using the Chi‐square test or Fisher's exact test. A two‐tailed p‐value of <0.05 was considered statistically significant. All analyses were performed using SPSS 27.0 0 software (IBM Corp., Armonk, NY, USA).

3.5. Ethics

According to institutional policy, approval from our Institutional Review Board was not required, and this study was completed in accordance with the Helsinki Declaration as revised in 2013.

4. Results

Of the 179 consecutive patients who underwent ICE‐guided PFO closure, 126 received a femoral vein approach using the two‐in‐one technique and 53 received a bilateral femoral vein puncture.

There were no significant differences in baseline patient characteristics (Table 1) except for a higher proportion of overweight patients in the bilateral puncture group (12 (9.6%) vs. 12 (22.6%); p = 0.0198). Mean age at PFO closure was comparable between the two groups (47.32 ± 11.83 and 47.28 ± 11.58; p = 0.982). The prevalence of history of migraine was 21.6% and 21.2% in the two‐in‐one and bilateral puncture groups, respectively (p = 0.948). In addition, 18 patients (14.3%) in the two‐in‐one puncture group and eight (15.1%) in the bilateral puncture group had a history of stroke before the qualifying event (p = 0.889). Finally, more than three‐quarters of the PFOs were associated with an atrial septal aneurysm (102 (81.6%) and 39 (76.5%); p = 0.439).

Table 1.

Baseline characteristics.

	Two in one technique N = 126	Bilateral puncture N = 53	p‐value
Demographic characteristics
Age at inclusion	47.32 ± 11.83	47.28 ± 11.58	0.982
Male sex	72 (57.1)	34 (64.2)	0.384
Hypertension	13 (10.3)	9 (17)	0.215
Diabetes	2 (1.6)	2 (3.8)	0.583
Current smoker	28 (22.4)	16 (30.2)	0.271
Dyslipidemia	14 (11.1)	6 (11.3)	0.968
Body mass index ≥30	12 (9.6)	12 (22.6)	0.020
Estrogen–progestin contraceptives	15 (12)	3 (5.8)	0.80
Migraine	27 (21.6)	11 (21.2)	0.948
Prior stroke	18 (14.3)	8 (15.1)	0.889
Prior MI	0 (0)	0 (0)	1.000
DVT or PE	11 (8.7)	5 (9.4)	0.880
Qualifying event
Stroke	120 (95.2)	46 (86.8)	0.047
TIA	6 (4.8)	7 (13.2)	0.047
Age at event	46.11 ± 12.00	42.81 ± 12.48	0.982
NIHSS	3.59 ± 5.27	2.26 ± 4.96	0.130
RoPE score	7.14 ± 1.43	7.25 ± 1.62	0.650
CHADS‐VASc	2.06 ± 1.22	2 ± 1.12	0.745
CHADS‐VASc >2	44 (35.2)	16 (30.8)	0.571
Echocardiography
Preserved LVEF (>50%)	123 (99.2)	50 (100)	1.000
Indexed LA volume (mL/m²)	22.30 ± 6.81	22.49 ± 6.72	0.901
Atrial septal aneurysm	102 (81.6)	39 (76.5)	0.439

Note: Data are presented as n (%) or mean ± SD.

Abbreviations: DVT, deep veinous thrombosis; LA, left atrial; LVEF, left ventricular ejection fraction; MI, myocardial infarction; PE, pulmonary embolism; TIA, transient ischemic attack.

In terms of procedural and post‐procedural characteristics (Table 2), both groups had a 100% success rate with no tamponade, no device migration and no death. Patient‐reported comfort was significantly higher in the two‐in‐one group (9.2 vs. 8.4; p = 0.044). Finally, procedure time was significantly shorter in the two‐in‐one technique group (40 min [32; 50] vs. 60 min [48; 70]; p < 0.001) as well as hospital stay duration (0.82 ± 1.02 days vs. 2.04 ± 0.83 days; p < 0.001) and fluoroscopy time (5.71 min [4.28; 8.33] vs. 9.57 min [7.42; 13.11]; p < 0.001).

Table 2.

Procedure and post procedure characteristics.

	Two in one technique N = 126	Bilateral puncture N = 53	p‐value
Procedure
Procedural success	126 (100)	53 (100)	1.000
Fluoroscopy time (min)	5.71 [4.28; 8.33]	9.57 [7.42; 13.11]	<0.001
Procedure time (min)	40 [32; 50]	60 [48; 70]	<0.001
Vascular closing
Compression	4 (3,2)	49 (92.5)	<0.001
Suture based VCD	122 (96.8)	4 (7.5)	<0.001
Patient comfort rating (/10)	9.20 ± 1.55	8,44 ± 1.93	0.044
Device
PFO Occluder Abbott	77 (61.1)	36 (67.9)	0.388
25	68 (54)	25 (47.2)
35	9 (7.1)	11 (20.8)
Cribriform Abbott	45 (35.7)	19 (18.9)	0.026
25	17 (13.5)	2 (3.8)
30	15 (11.9)	6 (11.3)
35	13 (10.3)	2 (3.8)
Ultrasept Cardia Inc	4 (3.2)	7 (13.2)	0.017
25	2 (1.6)	0
30	2 (1.6)	7 (13.2)
35	0	0
Post procedure
Vascular complication	3 (2.4)	2 (3.8)	0.634
Device migration	0	0	1.000
SVT	2 (1.6)	2 (3.8)	0.583
Tamponnade	0	0	1.000
Death	0	0	1.000
Hospital stay duration (days)	0.82 ± 1.02	2.04 ± 0.83	<0.001

Note: Data are presented as n (%), mean ± SD or median [IQR].

Abbreviations: SVT, supraventricular tachycardia; VCD, vascular closure device.

4.1. Vascular Complications

The vascular complication rate was low in both groups, with three patients (1.6%) in the two‐in‐one group and two patients (3.8%) in the bilateral puncture group (p = 0.582).

In the two‐in‐one puncture group, the first case was an accidental arterial puncture requiring manual compression followed by compression bandaging. Doppler ultrasound showed no vascular lesions except for a noncirculating hematoma.

The complication was graded BARC 2. The second and third cases involved persistent venous bleeding on removal of the compression bandage, requiring further compression and delaying discharge until the following day. These complications were graded as BARC 2.

In the double puncture group, the first case was an accidental arterial puncture complicated by a false aneurysm requiring embolization. The patient was discharged 3 days after PFO closure. The complication was classified as BARC 3b. In the second case, venous bleeding persisted after removal of the compression bandage, requiring further compression, and discharge was delayed until the following day. This complication was classified as BARC 2.

5. Discussion

The key findings of our study are:

• –ICE‐guided PFO closure was associated with a 100% success rate regardless of vascular technique.
• –Compared to the classical two‐puncture technique, the two‐in‐one technique was associated with the same (and low) rate of vascular complications.
• –In addition, the two‐in‐one technique was significantly associated with increased patient‐reported comfort, decreased procedure time, fluoroscopy time and hospital stay duration.

ICE‐guided PFO closure allows the procedure to be performed without the need for general anesthesia. However, it does require an additional vascular approach, which can be achieved using the two‐in‐one puncture technique. Our data showing a high procedural success rate and a low rate of periprocedural complications, are consistent with the growing evidence on safety and efficacy of ICE‐guided PFO closure [12, 13, 16, 17]. However, to our knowledge, there is currently only one randomized controlled trial, carried out by Bartel et al. in 2003, comparing ICE‐guided with TEE‐guided PFO closure with a small sample size of 44 patients [18]. To confirm these encouraging results, these data would need to be confirmed in a larger randomized controlled trial.

The first study describing the “two‐in‐one” technique was published by Morita et al, who demonstrated the feasibility and safety of this technique using small bore 5F introducers in a series of 56 patients to perform adrenal venous sampling [14]. To the best of our knowledge, our study is the first to demonstrate the safety of this puncture technique in a larger cohort using introducers adapted to structural heart procedures and allowing ICE guidance. However, if we consider only major vascular complications, usually defined as BARC ≥ 3, we note that there were none in the single puncture group and only one in the double puncture group, underscoring the excellent safety profile of both techniques. Finally, of the five vascular complications, two were related to accidental arterial puncture, which may support the hypothesis that limiting the number of punctures may reduce the rate of vascular complications. Although this technique had a similar safety profile to the double puncture technique, it did not show a significant reduction in vascular complications and therefore did not confirm this hypothesis.

Length of stay was also reduced in the two‐in‐one group, with many patients discharged on the same day of the procedure after clinical assessment of the puncture site and echocardiographic evaluation (68 patients (54%)). The data from our cohort strongly encourage us to perform as many procedures as possible on an outpatient basis and are consistent with those from other cohorts that have also shown results in favor of same‐day discharge [19]. In addition, the procedure time reduction associated with the gain in human resources, especially anesthesia resources and interventional echocardiographers, could at least simplify cath‐lab scheduling and perhaps partially offset the additional cost of using an intracardiac ultrasound probe. However, this needs to be confirmed by medico‐economic studies.

Finally, it is possible that limiting the number of punctures, as well as working unilaterally, may help improve patient comfort per procedure. Our experience with this technique has also led us to use it for ICE‐guided left atrial appendage occlusion under and transcatheter mitral valve replacement under local anesthesia [20, 21]. We believe this is a promising technique given the increasing number of structural heart procedures that can be performed percutaneously and the development of 3‐dimensional ICE probes that allow even more precise guidance. This puncture technique could also be used in electrophysiology where multiple introducers are required.

5.1. Limitations

Our study should be interpreted with the following limitations. First, we describe a single‐center experience. The safety of this technique would need to be supported by larger multicenter cohorts.

Furthermore, the choice of puncture technique was left to the operator's practice, so it is possible that fluoroscopy times and hospital stays were also influenced by the practices of the different interventional cardiology teams (per operator analyses in Table S1). However, as these were experienced teams in both techniques, it seems unlikely that this contributed to a bias in the vascular complication rate. Finally, the choice of vascular closure technique could partially influence procedure duration.

6. Conclusion

Our study shows that the two‐in‐one puncture technique, which allows two introducers to be placed in a single hole, is a safe and effective way to achieve PFO closure under ICE guidance and can be performed on an outpatient basis. It also appears to improve patient comfort. However, these data need to be confirmed in a larger multicenter study.

Conflicts of Interest

The authors declare no conflicts of interest.

Supporting information

Supporting information.

Data Availability Statement

The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.