A suture not always the ideal solution: Problems encountered in developing a suture-based PFO closure technique

A Suture is not Always the Ideal Solution: ProblemsEncountered in Developing a Suture-Based

PFO Closure Technique

Nicolas Majunke,1 Andreas Baranowski,1 Wibke Zimmermann,1

Corinna Heinisch,1 MD, Neil Wilson,1 MD, Greg Robertson,2 MD,Nina Wunderlich,1 MD, and Horst Sievert,1,3* MD

Objectives: To summarize our experiences with the first-in-man suture-based patentforamen ovale (PFO) closure technique. Background: PFO is often present with theoccurrence of cryptogenic stroke and migraine with aura. Successful PFO closure canbe performed percutaneously using catheter techniques with many different closuredevices. The described novel closure system is intended to deliver, via endovascularaccess, a suture into the atrial septal wall tissue for closure of PFO. Methods: Elevenpatients, between 22 and 58 years of age (mean 46.6 6 9.6), who had a cryptogenic is-chemic stroke, TIA, or a peripheral embolism and a PFO were considered for percuta-neous closure with this technique. Results: The mean stretched diameter of the defectevaluated during balloon sizing was 8.8 6 0.4 mm (range 7–12.5). Delivery of the suturewas successful in all patients. No intraprocedural complications occurred. During thefollow up, complete closure could be achieved in one patient. Six patients with signifi-cant residual shunting during follow-up had successful closure using a conventionaldevice. One patient was lost for follow-up after the 3-month visit. The residual shunt inthe remaining three patients was very small and they declined to be treated with a con-ventional device. No complications occurred during the follow up. Conclusions: Tran-scatheter application of a suture for closure of PFO is technically feasible and safe.However, despite successful suturing of the septum primum to the septum secundum,the PFO did not close in most of the patients. ' 2008 Wiley-Liss, Inc.

Key words: percutaneous; patent foramen ovale; stroke; congenital heart disease

INTRODUCTION

Patent foramen ovale (PFO) is a relatively commoncongenital condition that occurs in 27–30% of the pop-ulation [1]. It may be involved in multiple diseaseprocesses including cryptogenic stroke and TIA [2],peripheral embolism, decompression sickness [3], andmigraine headache with aura [4]. Transcatheter techni-ques to close PFO have been used with increasing fre-quency [5–10]. Initially, only devices designed for clo-sure of atrial septal defects were available for PFOclosure. However, permanent implants have at timesresulted in arrhythmias, erosions, and thrombus for-mation. The current trend for PFO closure is usingPFO-specific devices. New technologies minimizingthe foreign material in the atria, such as bioresorbablematerial [9], radiofrequency delivery [10], and suture-based PFO closure systems [11] have been developed.Potential advantages of these devices are reducedrisk of thrombus formation, minimizing postprocedureanticoagulation use, and preserving future left atrial

Conflict of interest: Dr. Sievert’s conflicts of interest: Consulting

fees, Travel expenses, Study honoraria: Abbott, Access Closure,

AGA, Angiomed, Boston, CardioKinetix, CardioMEMS, Cierra,

Coherex, Coaptus, Cordis, CSI, Edwards, EndoTex, ev3, FlowCar-

dia, Gore, Guidant, Invatec, Lumen Biomedical, Kensey Nash,

NDC, NMT, OAS, Occlutech, Ovalis, Pathway, pfm PendraCare

Percardia, Remon, Rox Medical, Sadra, Sorin, Spectranetics, St.

Jude, Terumo, Topspin, Velocimed, Xtent. Stock options, Stocks:

Cardiokinetix, Access Closure, Velocimed, Cierra, CoAptus,

Lumen Biomedical.

1CardioVascular Center Frankfurt, Frankfurt, Germany2Emory Heart and Vascular, Emory University, Atlanta3Washington Hospital Center, Washington, District of Columbia

*Correspondence to: Horst Sievert, MD, CardioVascular Center

Frankfurt, Seckbacher Landstrasse 65, 60389 Frankfurt, Germany.

E-mail: [email protected]

Received 30 August 2008; Revision accepted 6 September 2008

DOI 10.1002/ccd.21821

Published online 9 December 2008 in Wiley InterScience (www.

interscience.wiley.com).

' 2008 Wiley-Liss, Inc.

Catheterization and Cardiovascular Interventions 73:376–382 (2009)

access. This study was designed to assess for the firsttime in humans the feasibility, safety, and efficacy of anew suture-based technique in the closure of PFO.

MATERIALS AND METHODS

Patients

Between April 2006 and August 2006, 11 consecu-tive patients with PFO and at least one paradoxicalembolic event underwent percutaneous transcatheterclosure with a new suture-based closure technique. Theage of the patients ranged from 22 to 58 years (mean46.6 6 9.6). Weight ranged from 54 to 126 kg (mean79.7 6 21.3 kg). Seven patients were treated for theindication of stroke, three for TIA, and the remainingone was treated for peripheral embolism. Routine ex-amination before the procedure included ECG, stand-ard blood tests, and transcranial Doppler (TCD) study.Before discharge, ECG, a biplane chest X-ray, a trans-thoracic echocardiogram (TTE), and a TCD were per-

formed. Patients were discharged on a regimen of aspi-rin, a minimum of 75 mg per day for 6 months, andclopidogrel, 75 mg every day for 30 days. Patientswere advised to follow subacute bacterial endocarditisprophylaxis for 6 months after the procedure. Follow-up examinations, including clinical investigation, ECG,transesophageal echocardiography (TEE), and TCD,were scheduled at 1, 3, 6, and 12 months after theprocedure.

Description of the Catheter System

The described closure system is intended to deliverand implant a suture into the atrial septal wall tissuefor closure of PFO. A clip is used to tighten and to fixthe suture. The system comprised three catheter-basedcomponents: (1) a guide catheter (Fig. 1), (2) a vac-uum-assisted therapy catheter (Fig. 2) to capture andsuture the septum primum and septum secundumacross the PFO using a USP 4-0 polypropylene suture,and (3) a fastener catheter (Fig. 3) to complete the

Fig. 1. Guide catheter.

Fig. 2. Therapy catheter.

Fig. 3. Fastener catheter.

Percutaneous Suture-Based PFO Closure Technique 377

Catheterization and Cardiovascular Interventions DOI 10.1002/ccd.Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).

procedure by deploying a suture-clip to secure thestitch and trim the excess suture material.

Description of the Procedure

After all patients gave written informed consent,PFO closure was undertaken under conscious sedationwith TEE and fluoroscopy guidance. Preprocedurally,all patients received intravenous antibiotic prophylaxisas per the center’s standard operating procedures.Patients were systemically anticoagulated at the timeof the procedure with 10.000 IU intravenous heparin.After right common femoral venous access was rou-tinely achieved, the PFO was crossed with a fiveFrench multipurpose catheter and placed in the leftupper pulmonary vein. A soft-tipped guidewire wasleft in the pulmonary vein, and a sizing balloon (NMTMedical) was used to determine the anatomy and sizeof the defect. After removal of the sizing balloon, theguide catheter was inserted and the distal tip wasadvanced in the right atrium for a direct approach intothe PFO. Once the guide catheter was in place, thetherapy catheter was advanced over the guidewire,through the guide catheter and into the left atrium.Using TEE and fluoroscopy guidance, the vacuum portof the therapy catheter was positioned toward the sep-tum secundum while still barely within the left atrium.Then, vacuum was applied and the therapy catheterwas slowly retracted toward the right atrium until tis-sue capture was indicated by a complete stoppage ofblood flow into the vacuum canister. If capture did notoccur, the steps were repeated until the target tissuewas captured in the vacuum port. After device positionconfirmation by TEE and blood flow cessation, a nee-dle was actuated using a handle trigger to capture theseptal tissue (Fig. 4). At the distal end of the vacuumport, a small hypotube called the ‘‘catcher’’ is locatedin a support housing. This catcher is connected distallyto the 4-0 USP polypropylene suture tail ends, and theneedle inserts proximally into it. As the needle andcatcher pulled back through the septal tissue, the suturewas pulled through to complete the stitch (Fig. 4).After confirming that the stitch has been placed into

the septum secundum, the vacuum port was rotated1808 and the device was repositioned so that the vac-uum port was within the PFO and just proximal to theleft atrium. The steps of capturing and stitching wererepeated to suture septum primum. Once the secondneedle was fired and retracted and suturing of the sep-tum primum was confirmed, the therapy catheter wasslowly removed out of the guide catheter. The suturetails were removed from the therapy catheter andloaded into the fastener catheter. Using the two suturesas guidewires, the fastener catheter was advanced intothe PFO. After advancing the fastener catheter up tothe stitch locations, the suture-clip (Fig. 5) was deployedand the suture tails were cut. The remaining suture mate-rial and fastener catheter were removed. A TEE studywas performed to assess residual shunting through thePFO. In some patients with residual shunting, a secondor third suture and suture-clip was applied.

Follow-Up Examinations

Residual shunts were assessed by contrast TEE, atrest and during the valsalva maneuver, according to aspecified protocol. Shunt size was graded as negative(no bubbles seen in the left heart), trace (1–5 bubblesseen in the left heart), moderate (11–30 bubbles seenin the left heart), and large (>30 bubbles seen in theleft heart). Echocardiograms were recorded onto video-tape and were subsequently reviewed by an independ-

Fig. 4. Needle and suture mechanism.

Fig. 5. Clip.

378 Majunke et al.


ent core laboratory (Cardiovascular Research Institute,Washington Hospital Center, Washington, USA). Addi-tionally, a TCD study was performed at baseline (pre-procedure), immediately postprocedure, and at eachfollow-up visit and was reviewed in our center. Inbrief, 10 mL of air-mixed saline was injected into anantecubital vein while the Doppler signal from theright or left middle cerebral artery during normalbreathing and before a Valsalva maneuver wererecorded. When a right to left shunt is present, airmicrobubbles were counted on the spectral display ofthe insonated artery. We subsequently classified theshunt size for each patient [12]: small (<10 bubbles)and large (>10 bubbles) shunt with further subdivisionof large shunts in ‘‘shower’’ (>25 bubbles) and ‘‘cur-tain’’ (uncountable signals) patterns.

RESULTS

Eleven patients were treated with this suture-basedPFO closure technique. The defect diameters of thesepatients were measured by balloon sizing and rangedfrom 7 to 12.5 mm (mean 8.8 6 0.4). In sevenpatients one suture was applied, in three patients twosutures applied, and in one patient three sutures wereapplied. The procedural times ranged from 40 to 120min (mean 78.2 6 21.6) and the fluoroscopy timesfrom 9.6 to 31.6 min (mean 15.8 6 6.4). No complica-tions occurred during hospitalization or at the follow-up examinations ranging 3–18 months (mean 15 6 4months). Residual shunting was studied by TCD andTEE. Follow-up TEE data, reviewed by the core lab,is available for the 30-day follow-up in 100% (11/11)of the patients and for the 3-month follow-up in 91%(10/11). In one patient, a transthoracic echocardiograminstead of a TEE was performed 3-month postimplantbecause the patient did not fast before the exam. Clo-sure rates are summarized in Table I. One patientrefused further follow-up after the 3-month follow-up.The 6-month postimplant TEE data is available in82% (9/11) of the patients and was analyzed in ourcenter. Follow-up TCD data is available in 100% (11/11) of the patients for the 30-day follow-up, in 91%(10/11) of the patients for the 3 months follow-up, andin 82% (9/11) of the patients for the 6-month follow-up. The follow-up closure rates can be seen in TableII. A decrease of the shunt could be seen in the major-ity of the patients. Nevertheless, complete closure (noright to left shunt on TEE and TCD) was achieved inone patient. Six patients required reintervention for sig-nificant residual shunting at follow up. All were treatedsuccessfully by percutaneous placement of a conven-tional device. One patient was lost for follow up afterthe 3-month visit. The residual shunt in the remaining

three patients was very small and they declined to betreated with a conventional device.

DISCUSSION

This study demonstrates that it is feasible and safeto place a suture through the septum primum andsecundum in selected patients with a PFO. There wereno complications during this study. A decrease inright-to-left shunt as seen by TEE was achieved in allpatients. However, complete closure could be achievedin only one patient.Transcatheter techniques with implant devices have

been used with increasing frequency over the last yearsand have been associated with favorable safety and ef-ficacy in terms of secondary stroke prophylaxis [13–15]. In previous studies, PFO closure rates withimplant devices ranged from 66 to 99% [6,16,17].Despite the benefits of these devices, there remains

the potential disadvantage of large foreign material inthe atria. Potential complications associated with PFOimplant devices include thrombus formation [18–20],device erosion [21–23], and atrial fibrillation [24–26].Another disadvantage seems to be that these devicesmay obstruct transeptal access to the left atrium andpreclude the treatment of acquired heart disease such

TABLE I. Size of Right-to-Left Shunt (TEE)

% (n)

Preprocedure or intra-procedure (before

catheter manipulation of the PFO)

Large shunt (>30 bubbles) 64 (7/11)

Moderate shunt (11–30 bubbles) 18 (2/11)

Small shunt (6–10 bubbles) 18 (2/11)

Trace shunt (1–5 bubbles) –

No PFO –

1-month follow-up

Large shunt (>30 bubbles) –

Moderate shunt (11–30 bubbles) –


Trace shunt (1–5 bubbles) 36 (4/11)

No PFO 18 (2/11)

3-month follow-up

Large shunt (>30 bubbles) –




No PFO 30 (3/10)

6-month follow-up

Large shunt (>30 bubbles) 11 (1/9)




No PFO 22 (2/9)

Data are expressed as number of patients (n) and percentage (%).

TEE, transesophageal echocardiogram.



as percutaneous heart valve repair and replacement,left atrial appendage closure, and arrhythmia interven-tion. Therefore, new technologies minimizing foreignmaterial is being developed such as bioresorbable devi-ces [9], nondevice closure systems [10], or deviceswith nonumbrella architecture.PFO suture-based closure is the surgical standard;

however, our preliminary experience revealed its diffi-culties with current percutaneous technologies. Severalinvestigators reported surgical PFO closure and cere-brovascular event results [27–29]. Devuyst et al. [27]reported on 30 patients with a mean age of 38 yearsand a mean follow-up of 2 years. All patients had adirect suture of PFO, whereas under cardiopulmonarybypass, a single continuous suture was used for fivepatients, and a double continuous suture was used for25 patients. When a septal aneurysm was associated, itwas also surgically corrected. TEE simultaneous withtranscranial Doppler ultrasonography after contrastinjection at 8 6 3 months after surgery showed 4(13%) residual interatrial right-to-left shunting in thepatients repaired with a single suture. Homma et al.[28] presented the results of 28 cryptogenic strokepatients with a mean age of 41 years who had under-gone PFO closure by open thoracotomy. All PFOswere closed by primary anastomoses without the useof patch material. PFO closure rates on the basis ofechocardiographic evaluation are not described in thispublication. Dearani et al. [29] reported on 91 patientswith a mean age of 44 years and a mean follow-up1.9 6 2.2 years. All patients underwent standard car-

diac surgical techniques with cardiopulmonary bypassand cardioplegic arrest. The defect was closed primar-ily in 82 patients and with an autologous pericardialpatch in nine patients. An intraoperative TEE was per-formed to confirm closure of the defect and to documentno residual shunt across the atrial septum in all but onepatient (A TEE in later years documented closure of thedefect). TEE examination during follow-up has systemati-cally been performed only by Devuyst et al.In contrast to transcatheter PFO closure, patients

undergoing surgical PFO closure have not systemati-cally been re-evaluated for residual shunting. There-fore, Schneider and Bauer [30] assessed the efficacy ofsurgical PFO closure during follow-up using contrastand color flow TEE. Eleven patients with diagnosis ofa PFO by contrast and/or color flow TEE underwentsurgical PFO closure. A second TEE was performed5–210 days postoperatively and revealed residualshunting in 8 of 11 patients (73%). The mechanism forpersistent shunting was incomplete sealing of septumprimum and septum secundum by the suture line (n 56) or a new iatrogenic defect of the fossa ovalis causedby surgical manipulation (n 5 2). Although technicallynot challenging, complete closure rate after directsuturing of the PFO is low, and even new iatrogenicatrial septal defects caused by surgical manipulationmay occur.Direct suturing of the PFO, as performed in the

operating room, is technically easier than using trans-catheter technique. Our major challenge was the limi-tation in accurately placing the suture for optimal

TABLE II. Size of Right-to-Left Shunt (TCD)

% (n) Subdivision of large shunt % (n)

Pre-procedure

Large shunt (>10 bubbles) 100 (11/11) Shower (>25 bubbles) 45 (5/11)

Curtain (uncountable signals) 45 (5/11)

Small shunt (<10 bubbles) –

No PFO –

1-month follow-up


Curtain (uncountable signals) –

Small shunt (<10 bubbles) 18 (2/11)

No PFO –

3-month follow-up




No PFO 10 (1/10)

6-month follow-up




No PFO 11 (1/9)

Data are expressed as number of patients (n) and percentage (%).

TCD, transcranial Doppler.

380 Majunke et al.


adhesion of the septum primum and secundum due tolimited visibility. Our second challenge was suturingthe septum primum and secundum in two separatesteps causing potential malalignment. After the septumsecundum was punctured, the catheter had to berotated to capture the septum primum, which had oftenled to malalignment of the two septums (Fig. 6).The primary closure rates with currently available

percutaneous technologies range from 66 to 99%[6,16,17]. Although in our series right-to-left shuntdecreased in all patients, complete closure wasachieved in only one patient. In most cases, postproce-dural thromboembolic events have been referred torecurrent paradoxical embolism through persistent pat-ency of foramen ovale [14,31,32]. The goal of alldevices is to attain a consistent complete closure andneed stringent follow-up exams for evaluation usingTEE and TCD for meaningful comparison.

CONCLUSIONS

Transcatheter application of a suture for the closureof PFO is technically feasible and safe. However,

despite successful suturing of the septum primum tothe septum secundum, the PFO did not close in mostof the patients. Technique and device modifications aremandatory to improve closure rates.

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Documents

A suture not always the ideal solution: Problems encountered in developing a suture-based PFO closure technique