Catheterization and Cardiovascular Interventions 86:113–114 (2015)
Editorial Comment Percutaneous Closure of the Patent Foramen Ovale, Easy Does It Bernhard Meier,* MD, FACC Department of Cardiology, Bern University Hospital, Bern, Switzerland
Key Points
Closure of the patent foramen ovale does not benefit from echocardiographic guidance in the majority of cases. Guiding these procedures with fluoroscopy only reduces procedure time, radiation exposure, and amount of contrast medium. There is a clear trend to abandon echocardiographic guidance for this procedure over time and with growing experience.
For once, easy does it means to be less cautious and speed up rather than to be cautious and go slowly. Percutaneous closure of the patent foramen ovale (PFO) has been clinically used for 23 years [1]. Guidance with transesophageal echocardiography (TEE) was an integral part of the original cases. I am looking back on 21 years of personal respective experience with over 3,000 cases, not using echocardiographic guidance in any of them. None of these patients died during the hospitalization or later because of a complication. One patient needed surgery before hospital discharge (groin problem) and one during follow-up (erosion of a coronary artery at three months). Could the use of either TEE or intracardiac echocardiography (ICE) have improved on these results? I will let you be the judge of it. The report in this issue by a rather low-volume center closing less than 60 PFOs per year distributed among several operators finds no improvement in short-term or long-term results with the use of either TEE or ICE. The cases were not randomized and the authors mention that perhaps the more complex situations were handled with TEE or ICE. On the other hand, they exhibit a clear trend to abandon TEE or ICE with growing experience. This analysis of their cases must have boosted the number of fluoroscopy-only cases in the 4 years that have passed C 2015 Wiley Periodicals, Inc. V
since. They showed an incidence of 4% of cross-over to TEE or ICE in contrast to our almost 10 times larger series where there was none. Looking at these cases it is not quite clear, what echocardiography was contributing to successfully finishing the cases. In more than half of cross-over cases it was difficult to pass the PFO. Echocardiography typically shows that you have passed the PFO but does not really help to manipulate wires or catheters to that end. The instruments are not seen in their full length and their tips cannot be reliably identified. Echocardiography was also used to rule out pericardial effusion in two patients showing hemodynamic instability which finally was attributed to air embolism. Fluoroscopy is very much able to screen for pericardial effusion. Moreover patients without the sedation needed exclusively for TEE will invariably report chest pain when pericardial bleeding occurs. Pericardial effusion during PFO closure is an extreme rarity as neither transseptal puncture nor manipulations at the free walls of the atria are involved. Echocardiography was also used in a case with device embolization. Again, this is obvious on fluoroscopy which is also the tool to find out where the device has embolized to. Interestingly, not using TEE or ICE reduced not only overall procedure times by 20% but also fluoroscopy times to about the same extent. This significantly impacted on measured radiation doses. In contrast to what is usually assumed, 10% less fluoroscopic contrast medium was used when foregoing echocardiographic guidance. Advocates of ICE highlight the patient comfort compared to using TEE but they typically fail to mention that two venous punctures double the respective discomfort and risk for arterio-venous (AV) fistulae. AV fistulae were apparently not a problem in any of the two groups here but they will go undetected unless Conflict of interest: Research grants to the institution and speaker fees from St. Jude Medical *Correspondence to: Bernhard Meier, MD, Professor and Chairman of Cardiology, Cardiovascular Department, University Hospital Bern, 3010 Bern, Switzerland. E-mail: [email protected] Received 11 May 2015; Revision accepted 11 May 2015 DOI: 10.1002/ccd.26046 Published online 27 May 2015 in Wiley Online Library (wileyonlinelibrary.com)
114
Meier
contrast to left atrial appendage closure, the other preventive procedure, PFO closure is the most simple and safest intervention in cardiology. It is simple with the use of TEE or ICE and even more easy without. Only two PFO closures are required to prevent one stroke, with an expected follow-up of 50 years or more regardless of whether you follow the trend to use fluoroscopy only or stick to echocardiographic guidance [5].
REFERENCES
Fig. 1. Intricacy of adult interventional cardiology procedures. ASD 5 atrial septal defect; LAA 5 left atrial appendage; PCI 5 percutaneous coronary intervention; PFO 5 patent foramen ovale; TAVI 5 transcatheter aortic valve implantation.
specifically looked for during follow-up. Their clinical importance is small but not negligible. The literature is replete with series on fluoroscopyonly guided PFO closure [2,3]. Notably operators in the only paper proving a mortality benefit with PFO closure during long-term follow-up used no echocardiographic guidance [4]. PFO closure is one of only two preventive procedures of modern interventional cardiology (Fig. 1). In
1. Bridges ND, Hellenbrand W, Latson L, Filiano J, Newburger JW, Lock JE. Transcatheter closure of patent foramen ovale after presumed paradoxical embolism. Circulation. 1992;86:1902–1908. 2. Wahl A, Praz F, Stinimann J, Windecker S, Seiler C, Nedeltchev K, Mattle HP, Meier B. Safety and feasibility of percutaneous closure of patent foramen ovale without intra-procedural echocardiography in 825 patients. Swiss Med Wkly 2008;138:567–572. 3. Hildick-Smith D, Behan MW, Haworth P, Rana BS, Thomas MR. Patent foramen ovale closure without echocardiographic control: Use of “standby” intracardiac ultrasound. J Am Coll Cardiol Interv 2008;1:387–391. 4. Wahl A, J€uni P, Mono ML, Kalesan B, Praz F, Geister L, R€aber L, Nedeltchev K, Mattle HP, Windecker S, Meier B. Long-term propensity score-matched comparison of percutaneous closure of patent foramen ovale with medical treatment after paradoxical embolism. Circulation 2012;125:803–812. 5. Meier B, Juni P. Patent foramen ovale and cryptogenic stroke. N Engl J Med 2013;369:91.
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
Editorial Comment Percutaneous Closure of the Patent Foramen Ovale, Easy Does It Bernhard Meier,* MD, FACC Department of Cardiology, Bern University Hospital, Bern, Switzerland
Key Points
Closure of the patent foramen ovale does not benefit from echocardiographic guidance in the majority of cases. Guiding these procedures with fluoroscopy only reduces procedure time, radiation exposure, and amount of contrast medium. There is a clear trend to abandon echocardiographic guidance for this procedure over time and with growing experience.
For once, easy does it means to be less cautious and speed up rather than to be cautious and go slowly. Percutaneous closure of the patent foramen ovale (PFO) has been clinically used for 23 years [1]. Guidance with transesophageal echocardiography (TEE) was an integral part of the original cases. I am looking back on 21 years of personal respective experience with over 3,000 cases, not using echocardiographic guidance in any of them. None of these patients died during the hospitalization or later because of a complication. One patient needed surgery before hospital discharge (groin problem) and one during follow-up (erosion of a coronary artery at three months). Could the use of either TEE or intracardiac echocardiography (ICE) have improved on these results? I will let you be the judge of it. The report in this issue by a rather low-volume center closing less than 60 PFOs per year distributed among several operators finds no improvement in short-term or long-term results with the use of either TEE or ICE. The cases were not randomized and the authors mention that perhaps the more complex situations were handled with TEE or ICE. On the other hand, they exhibit a clear trend to abandon TEE or ICE with growing experience. This analysis of their cases must have boosted the number of fluoroscopy-only cases in the 4 years that have passed C 2015 Wiley Periodicals, Inc. V
since. They showed an incidence of 4% of cross-over to TEE or ICE in contrast to our almost 10 times larger series where there was none. Looking at these cases it is not quite clear, what echocardiography was contributing to successfully finishing the cases. In more than half of cross-over cases it was difficult to pass the PFO. Echocardiography typically shows that you have passed the PFO but does not really help to manipulate wires or catheters to that end. The instruments are not seen in their full length and their tips cannot be reliably identified. Echocardiography was also used to rule out pericardial effusion in two patients showing hemodynamic instability which finally was attributed to air embolism. Fluoroscopy is very much able to screen for pericardial effusion. Moreover patients without the sedation needed exclusively for TEE will invariably report chest pain when pericardial bleeding occurs. Pericardial effusion during PFO closure is an extreme rarity as neither transseptal puncture nor manipulations at the free walls of the atria are involved. Echocardiography was also used in a case with device embolization. Again, this is obvious on fluoroscopy which is also the tool to find out where the device has embolized to. Interestingly, not using TEE or ICE reduced not only overall procedure times by 20% but also fluoroscopy times to about the same extent. This significantly impacted on measured radiation doses. In contrast to what is usually assumed, 10% less fluoroscopic contrast medium was used when foregoing echocardiographic guidance. Advocates of ICE highlight the patient comfort compared to using TEE but they typically fail to mention that two venous punctures double the respective discomfort and risk for arterio-venous (AV) fistulae. AV fistulae were apparently not a problem in any of the two groups here but they will go undetected unless Conflict of interest: Research grants to the institution and speaker fees from St. Jude Medical *Correspondence to: Bernhard Meier, MD, Professor and Chairman of Cardiology, Cardiovascular Department, University Hospital Bern, 3010 Bern, Switzerland. E-mail: [email protected] Received 11 May 2015; Revision accepted 11 May 2015 DOI: 10.1002/ccd.26046 Published online 27 May 2015 in Wiley Online Library (wileyonlinelibrary.com)
114
Meier
contrast to left atrial appendage closure, the other preventive procedure, PFO closure is the most simple and safest intervention in cardiology. It is simple with the use of TEE or ICE and even more easy without. Only two PFO closures are required to prevent one stroke, with an expected follow-up of 50 years or more regardless of whether you follow the trend to use fluoroscopy only or stick to echocardiographic guidance [5].
REFERENCES
Fig. 1. Intricacy of adult interventional cardiology procedures. ASD 5 atrial septal defect; LAA 5 left atrial appendage; PCI 5 percutaneous coronary intervention; PFO 5 patent foramen ovale; TAVI 5 transcatheter aortic valve implantation.
specifically looked for during follow-up. Their clinical importance is small but not negligible. The literature is replete with series on fluoroscopyonly guided PFO closure [2,3]. Notably operators in the only paper proving a mortality benefit with PFO closure during long-term follow-up used no echocardiographic guidance [4]. PFO closure is one of only two preventive procedures of modern interventional cardiology (Fig. 1). In
1. Bridges ND, Hellenbrand W, Latson L, Filiano J, Newburger JW, Lock JE. Transcatheter closure of patent foramen ovale after presumed paradoxical embolism. Circulation. 1992;86:1902–1908. 2. Wahl A, Praz F, Stinimann J, Windecker S, Seiler C, Nedeltchev K, Mattle HP, Meier B. Safety and feasibility of percutaneous closure of patent foramen ovale without intra-procedural echocardiography in 825 patients. Swiss Med Wkly 2008;138:567–572. 3. Hildick-Smith D, Behan MW, Haworth P, Rana BS, Thomas MR. Patent foramen ovale closure without echocardiographic control: Use of “standby” intracardiac ultrasound. J Am Coll Cardiol Interv 2008;1:387–391. 4. Wahl A, J€uni P, Mono ML, Kalesan B, Praz F, Geister L, R€aber L, Nedeltchev K, Mattle HP, Windecker S, Meier B. Long-term propensity score-matched comparison of percutaneous closure of patent foramen ovale with medical treatment after paradoxical embolism. Circulation 2012;125:803–812. 5. Meier B, Juni P. Patent foramen ovale and cryptogenic stroke. N Engl J Med 2013;369:91.
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
