JACC: CARDIOVASCULAR INTERVENTIONS © 2012 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION PUBLISHED BY ELSEVIER INC. VOL. 5, NO. 4, 2012 ISSN 1936-8798/$36.00 DOI: 10.1016/j.jcin.2012.02.008 EDITORIAL COMMENT Some Air for Closure of the Patent Foramen Ovale* Bernhard Meier, MD Bern, Switzerland The patient is 56 years old. He likes sports, in particular deep-sea diving. After 2 decompression incidents, he was worked up by a cardiologist and a patent foramen ovale (PFO) was found. Incidentally, he mentioned that he has been increasingly short of breath during physical exercise. The PFO was closed (Fig. 1) in an outpatient procedure, and the next day, already, he enjoyed an improved exercise capacity when jogging. This effect proved to be sustained and diving has remained uneventful since. See page 416 It has been known but hardly discussed that a PFO can not only produce systemic arterial desaturation in elderly people sitting upright (platypnea-orthodeoxia) but also during exercise as in the patient described. What has not been known but is nicely shown by Devendra et al. (1) in this issue of JACC: Cardiovascular Interventions is that it may do so much more commonly than previously thought. The investigators found provoked exercise desaturation in every third patient. This percentage depends heavily on the indications for PFO closures and the referral pattern and appears much smaller in our personal experience. Nonetheless, it adds to the already lengthy list of possible indications for PFO closure (Table 1). The focus around PFO closure has always concentrated too much on patients with prior stroke or transient ischemic attacks. Notwithstanding, these are the most devastating problems a PFO can mediate and their issue may be lethal. However, paradoxical myocardial infarction may also bring about death and severe disability. The reticence to implant a device into the middle of the heart just for preventive reasons is understandable and has recently grown when the results of the yet unpublished CLOSURE I (A Prospective, Multicenter, Randomized, Controlled Trial to Evaluate the Safety and Efficacy of the *Editorials published in JACC: Cardiovascular Interventions reflect the views of the authors and do not necessarily represent the views of JACC: Cardiovascular Interventions or the American College of Cardiology. From the Cardiovascular Department, Bern University Hospital, Bern, Switzerland. Dr. Meier has received research grants from and has served on the Speaker’s Bureau of St. Jude Medical. Downloaded From: http://interventions.onlinejacc.org/ on 02/06/2015 STARFlex Septal Closure System vs. Best Medical Therapy in Patients with Stroke or Transient Ischemic Attack due to Presumed Paradoxical Embolism through a Patent Foramen Ovale) trial failed to prove an advantage of PFO closure over medical therapy during the first 2 years of follow-up. This may change should one or both of the controlled randomized trials on that topic that are expected to be published next meet their primary endpoints of superiority of PFO closure over medical treatment. The PC-Trial (Patent Foramen Ovale and Cryptogenic Embolism) (NCT00166257) (2) is in the analysis phase and encompasses roughly 400 patients followed-up for a minimum of 2 and a maximum of 10 years. The RESPECT (Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment) trial (NCT00465270) is about to be analyzed with a comparable follow-up duration in about 1,000 patients. Both trials exclusively used Amplatzer PFO occluders (St. Jude Medical, St. Paul, Minnesota), representing the state-of-theart devices. Meanwhile, the results of a propensity matched analysis of about 300 patients with either PFO closure using a variety of devices or medical treatment and a median follow-up of about 10 years supports the procedure by showing even a mortality benefit when comparing follow-up years with a closed PFO to those with an open PFO (3). To place a device into the heart for therapeutic reasons is a much more palatable situation as witnessed in the realm of interventional cardiology with coronary stenting and percutaneous valve replacement. The migraine indication has lost steam secondary to the negative MIST (Migraine Intervention with STARFlex Technology) trial (4). Yet, PFO closure does tame migraine symptoms in real life (5). Closing a PFO for platypnea-orthodeoxia is an uncontested but rare indication. The opposite is true for closing a PFO for sleep apnea. Now we do have the newcomer, provoked exercise desaturation. I suggest that we look for a PFO in patients complaining about unexplained exertional dyspnea and to close it when present, crossing our fingers that the symptoms will improve. If they do not, the patient will still enjoy the collateral benefit of not being at risk any longer for paradoxical embolism be it to the brain, the heart, or elsewhere. Leaving the PFO open means missing the chance of symptom improvement and leaving the patient exposed to rare but serious risks for the rest of his or her life, well aware of the fact that these risks increase with age in parallel to the increase of venous thrombosis (6). Should we go as far as to test symptomatic PFO carriers for provoked exercise desaturation as described by Devendra et al. (1)? Probably not, as we usually have a more compelling indication at hand. We are indebted to Devendra et al. (1) for opening our eyes to a fact that was there all the time but was just overlooked. Their original and insightful study on a small group of patients with a particular medical situation may help to open the door to what some day may become some Meier Editorial Comment JACC: CARDIOVASCULAR INTERVENTIONS, VOL. 5, NO. 4, 2012 APRIL 2012:420 –1 Frontal 421 Lateral TEE FU at 9 mo Perfect result LA Furrer Fredy, 07.03.1955, 11.04.2011, 05.01.2012 RA LA LA LA SS SP RA RA RA Figure 1. Right-to-Left Shunt Through a PFO Right-to-left shunt through a patent foramen ovale (PFO) (dashed arrow) demonstrated by contrast medium injection into the right atrium (RA) in the frontal and lateral projections. The bottom inset shows the immediate result after closure of the PFO with a 25-mm Amplatzer PFO occluder (St. Jude Medical, St. Paul, Minnesota) and the top inset shows the complete tightness at the 9-month follow-up (FU) transesophageal echocardiogram (TEE). LA ⫽ left atrium; SP ⫽ septum primum; SS ⫽ septum secundum. Table 1. Possible Indications for PFO Closure Secondary prevention kind of a PFO closure campaign. For the time being, their study gives PFO closure some direly needed but welldeserved air. Stroke Transient ischemic attack Embolic myocardial infarction Peripheral embolism Reprint requests and correspondence: Dr. Bernhard Meier, Cardiovascular Department, University Hospital Bern, 3010 Bern, Switzerland. E-mail: firstname.lastname@example.org. Compression incident Primary prevention Aggravating PFO attributes Atrial-septal aneurysm Eustachian valve Chiari network Deep vein thrombosis Pulmonary embolism Embolism-prone surgery Major orthopedic Cerebral in sitting position Planned pregnancy Therapeutic Migraine Platypnea-orthodeoxia Sleep apnea Provoked exercise desaturation Vocational or recreational Deep-sea diver Brass musician Glass blower Military jet pilot or astronaut Commercial driver or pilot PFO ⫽ patent foramen ovale. Downloaded From: http://interventions.onlinejacc.org/ on 02/06/2015 REFERENCES 1. Devendra GP, Rane AA, Krasuski RA. Provoked exercise desaturation in patent foramen ovale and impact of percutaneous closure. J Am Coll Cardiol Intv 2012;5:416 –9. 2. Khattab AA, Windecker S, Jüni P, et al. Randomized clinical trial comparing percutaneous closure of patent foramen ovale (PFO) using the Amplatzer PFO occluder with medical treatment in patients with cryptogenic embolism (PC-Trial): rationale and design. Trials 2011;12:56. 3. Wahl A, Jüni P, Mono ML, et al. Long-term propensity-score matched comparison of percutaneous closure of patent foramen ovale with medical treatment after paradoxical embolism. Circulation 2012;125:803–12. 4. Dowson A, Mullen MJ, Peatfield R, et al. Migraine Intervention with STARFlex Technology (MIST) trial: a prospective, multicenter, double-blind, sham-controlled trial to evaluate the effectiveness of patent foramen ovale closure with STARFlex septal repair implant to resolve refractory migraine headache. Circulation 2008;117:1397– 404. 5. Wahl A, Praz F, Tai T, et al. Improvement of migraine headaches after percutaneous closure of patent foramen ovale for secondary prevention of paradoxical embolism. Heart 2010;96:967–73. 6. Anderson FA Jr., Wheeler HB, Goldberg RJ, et al. A population-based perspective of the hospital incidence and case-fatality rates of deep vein thrombosis and pulmonary embolism. The Worcester DVT study. Arch Intern Med 1991;151:933– 8. Key Words: closure of patent foramen ovale 䡲 dyspnea 䡲 paradoxical embolism 䡲 platypnea-orthodeoxia.
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