Eustaquio Onorato

Outcome after percutaneous closure of a patent foramen ovale using the Intrasept device: a multi-centre study.

Objectives: This multi‐centre study reports safety and efficacy of percutaneous patent foramen ovale (PFO) closure, using the fourth generation Intrasept™ device. Background: PFO has been associated with paradoxical embolism and cryptogenic stroke. Percutaneous PFO closure seems to reduce the risk for recurrent paradoxical thrombo‐embolism. Currently, different devices are used for PFO closure. Methods: Patients, who underwent a PFO closure with the Intrasept device (Cardia, Eagan, MN) between July 2002 and September 2006, were included in the study. The primary endpoint was defined as reoccurrence of stroke, transient ischemic attack (TIA), or peripheral thrombo‐embolism. Peri‐procedural and mid‐term complications were reported. Results: Four‐hundred thirty patients (mean age 50.7 ± 13.0 years, 231 men) underwent closure. The indications were cryptogenic stroke (69.8%), TIA (23.5%), peripheral embolism (3.3%), and other (3.5%). The median follow‐up time was 0.8 years, range 3.9 years. The primary endpoint occurred in 0.5% for stroke, in 2.5% for TIA, and in none for peripheral embolism. Peri‐procedural complications were reported in 11.5% of cases, from which 0.2% was defined as major. No severe complications occurred during mid‐term follow‐up. A residual shunt was present in 12.5% of patients who did not suffer from a recurrent event, compared to 36.4% of patients who reached the primary endpoint (P = 0.04). Conclusion: This multi‐centre study suggests that percutaneous closure of a symptomatic PFO with the fourth generation Intrasept device is safe and might be effective to prevent the recurrence of paradoxical thrombo‐embolic events.

Persistent redundant Eustachian valve interfering with Amplatzer PFO occluder placement: Anatomico-clinical and technical implications

A 28‐year‐old man with patent foramen ovale and a prominent Eustachian valve with a history of transient ischemic attack underwent transcatheter closure using Amplatzer patent foramen ovale occluder. During deployment, some of the prominent valve tissue was entrapped on the delivery cable and a piece of the valve was extracted unintentionally. Anatomico‐clinical and technical implications are discussed. Cathet Cardiovasc Intervent 2002;55:521–524.

Transcatheter Amplatzer duct occluder closure of direct right pulmonary to left atrium communication.

Although rare, a congenital direct communication between pulmonary artery and left atrium can present a paradoxical embolism in adults. In our case, diagnosis was first made on contrast transcranial Doppler with Valsalva maneuver and subsequently confirmed by intracardiac echocardiography and selective pulmonary angiography. Successful catheter‐based closure using Amplatzer duct occluder device resulted in definitive exclusion of the source of paradoxical embolism. Cathet Cardiovasc Intervent 2003;58:107–110.

Closure of Secundum Atrial Septal Defects by Using the Occlutech Occluder Devices in More Than 1300 Patients: The IRFACODE Project: A Retrospective Case Series.

The Occlutech Figulla ASD device series (OFSO) shows an improved device design for interventional ASD closure, larger follow‐up series are missing.

Intracardiac echocardiography evaluation in secundum atrial septal defect transcatheter closure.

nPurpose: This study was designed tonassess the balloon sizing maneuvers and deployment of an AmplatzernSeptal Occluder (ASO). In addition, intraprocedural balloon sizing wasncompared with off-line intracardiac echocardiographic measurements. nMethods: The intracardiac echocardiography (ICE)nmeasurements were: maximum transverse and longitudinal atrial septalndefect (ASD) diameters in the aortic valve and four-chamber planes;narea of the ASD and its equivalent circle diameter. Thirteennconsecutive patients underwent transcatheter implantation of an ASOndevice using ICE guidance under local anesthesia. The device matchingnthe balloon sizing diameter of the defect was implanted. QualitativenICE assessment of the ASO devices implanted was performed off line. nResults: The mean equivalent circle diameter predicted bynICE was 24.40 ± 5.61 mm and was significantly highern(p = 0.027) than the ASD measured by balloonnsizing (21.38 ± 5.28 mm). Unlike previous studies we did not findnany correlation between the two measurements (correlationncoefficient = 0.47). Only four of the 13 patients had optimalndevice positioning as shown by the qualitative ICE evaluation, whereasnthe remaining nine patients had inadequate device placement. Thisnresulted in a waist diameter that was an average 26.1% undersized innseven patients and 12.7% oversized in two patients. Five of the sevennpatients with an undersized device had ASO-atrial septum misalignmentnwith leftward device deviation. nConclusion: The ICEnimages allowed careful measurement of the dimensions of the ASD andnaccurately displayed the spatial relations of the ASO astride the ASD.nMoreover, use of the ICE measurement led to selection of a differentnsize of device in comparison with those of balloon sizing. The clinicalnbenefit of this new approach needs to be rigorously tested.nn

Closure of Secundum Atrial Septal Defects by Using the Occlutech Occluder Devices in More Than 1300 Patients

The Occlutech Figulla ASD device series (OFSO) shows an improved device design for interventional ASD closure, larger follow‐up series are missing.

European position paper on the management of patients with patent foramen ovale. General approach and left circulation thromboembolism

The presence of a patent foramen ovale (PFO) is implicated in the pathogenesis of a number of medical conditions; however, the subject remains controversial and no official statements have been published. This interdisciplinary paper, prepared with involvement of eight European scientific societies, aims to review the available trial evidence and to define the principles needed to guide decision making in patients with PFO. In order to guarantee a strict process, position statements were developed with the use of a modified grading of recommendations assessment, development, and evaluation (GRADE) methodology. A critical qualitative and quantitative evaluation of diagnostic and therapeutic procedures was performed, including assessment of the risk/benefit ratio. The level of evidence and the strength of the position statements of particular management options were weighed and graded according to predefined scales. Despite being based often on limited and non-randomised data, while waiting for more conclusive evidence, it was possible to conclude on a number of position statements regarding a rational general approach to PFO management and to specific considerations regarding left circulation thromboembolism. For some therapeutic aspects, it was possible to express stricter position statements based on randomised trials. This position paper provides the first largely shared, interdisciplinary approach for a rational PFO management based on the best available evidence.

Data that may shed some light on: “Arguments against insisting on randomized trials for PFO closure”

A recent article in CCI [1] argues that the FDA should adopt a different approach than insisting on a randomized clinical trial (RCT) and permit the use of PFO closure devices to treat patients with cryptogenic stroke from a presumed paradoxical embolus. The author acknowledges that randomized trials comparing a device with medical therapy would result in powerful evidence that would support broad physician and patient consensus. Nonetheless, he opposes RCTs on practical, not theoretical grounds, arguing that, due to slow enrollment, ‘‘. . .trial completion can be anticipated no sooner than the year 2017.’’ This argument is not valid. Perhaps this reasoning is based on his experience with the CLOSURE Trial using the CardioSEAL (NMT Medical) device. However, the RESPECT trial using the Amplatzer device (AGA Medical) is recruiting patients at an acceptable rate of >100/year and is on target to achieve a sufficient number of enrolled patients by 2009 with publication of results in 2010. Although this may not be as fast as we all would like, the time frame is not unreasonable and it certainly argues against the gloomy prediction that these trials do not ‘‘. . .enroll at a rate that would encourage any optimism that they will proceed to completion.’’ The rate of enrolling patients into the RESPECT Trial is shown in Fig. 1. These data have not been presented before because the trial is not finished, but we felt it was important to speak out because the propagation of the concept that the trials will never be completed will only lead to discouragement among physicians and patients and make it more difficult to enroll appropriate candidates. If the randomized trials are not completed, there will always be nagging questions about the relative benefit and safety of these devices. Only a welldesigned RCT will convince all practitioners, patients, and payors that device closure is appropriate therapy for PFO and cryptogenic stroke. The RESPECT Trial is designed to demonstrate a statistically significant difference for recurrent stroke between medical and device therapy to close a PFO. All physicians should be encouraged by the information that trial completion is achievable in an acceptable time frame so that they will enroll all appropriate patients in the randomized trials. Interventional cardiologists should recognize that they perform a significant disservice to patients if they circumvent the RCTs and close a PFO ‘‘off label.’’ National treatment guidelines from the American Heart Association and the American Academy of Neurology do not recognize device closure as a therapy of proven benefit for cryptogenic stroke patients with PFOs and support the referral of patients for enrollment in RCTs [2,3]. The accompanying articles in the same issue of CCI [4,5] emphasize the many problems that will persist if an RCT is not accomplished in the field of PFO and cryptogenic stroke. Cryptogenic stroke is a disease state which is incompletely understood and diagnosed by variable means. Recurrent event rates under medical treatment are highly variable across different studies. Nonrandomized comparisons are vulnerable to Fig. 1. Patients enrolled each year in RESPECT TRIAL.