Name: closure of a patent foramen ovale (pfo): an intervention sequence
Uploaded: 2022-12-23T12:30:00
Description: Watch this Scientific Journal Video about Closure of a Patent Foramen Ovale PFO: An Intervention Sequence at JoVE.com

The protocol and video publication were approved by the ethics committee of the University Hospital Jena. The patient gave his agreement for his anonymized data to be published for article purposes.
1. Physiological monitoring
<ol>
	<li>After bringing the patient to the operating table, establish a peripheral venous access line and connect to 500 cc of NaCl. Fix the arms and legs of the patient.</li>
	<li>Initiate the ECG, peripheral oxygen saturation, and pulse measurements...

<ol>
	<li>Moore, K. L., Persaud, T. V. N., Torchia, M. G. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=.">.</a> The Developing Human: Clinically Oriented Embryology., 10th Edition. , (2015).</li><li>Hagen, P. T., Scholz, D. G., Edwards, W. D. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Incidence+and+size+of+patent+foramen+ovale+during+the+first+10+decades+of+life:+An+autopsy+study+of+965+normal+hearts.">Incidence and size of patent foramen ovale during the first 10 decades of life: An autopsy study of 965 normal hearts.</a> Mayo Clinic Proceedings. 59 (1), 17-20 (1984).</li><li>Meissner, I., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Prevalence+of+potential+risk+factors+for+stroke+assessed+by+transesophageal+echocardiography+and+carotid+ultrasonography:+The+SPARC+study.">Prevalence of potential risk factors for stroke assessed by transesophageal echocardiography and carotid ultrasonography: The SPARC study.</a> Mayo Clinic Proceedings. 74 (9), 862-869 (1999).</li><li>Rodriguez, C. J., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Race-ethnic+differences+in+patent+foramen+ovale,+atrial+septal+aneurysm,+and+right+atrial+anatomy+among+ischemic+stroke+patients.">Race-ethnic differences in patent foramen ovale, atrial septal aneurysm, and right atrial anatomy among ischemic stroke patients.</a> Stroke. 34 (9), 2097-2102 (2003).</li><li>Hara, H., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Patent+foramen+ovale:+Current+pathology,+pathophysiology,+and+clinical+status.">Patent foramen ovale: Current pathology, pathophysiology, and clinical status.</a> Journal of the American College of Cardiology. 46 (9), 1768-1776 (2005).</li><li>Saver, J. L. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Cryptogenic+stroke.">Cryptogenic stroke.</a> New England Journal of Medicine. 374 (21), 2065-2074 (2016).</li><li>Collado, F. M. S., Poulin, M. F., Murphy, J. J., Jneid, H., Kavinsky, C. J. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Patent+foramen+ovale+closure+for+stroke+prevention+and+other+disorders.">Patent foramen ovale closure for stroke prevention and other disorders.</a> Journal of the American Heart Association. 7 (12), 007146 (2018).</li><li>Choong, C. K., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Life-threatening+impending+paradoxical+embolus+caught+&amp;#34;red-handed&amp;#34;:+Successful+management+by+multidisciplinary+team+approach.">Life-threatening impending paradoxical embolus caught &amp;#34;red-handed&amp;#34;: Successful management by multidisciplinary team approach.</a> Journal of Thoracic and Cardiovascular Surgery. 136 (2), 527-528 (2008).</li><li>Madani, H., Ransom, P. A. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Paradoxical+embolus+illustrating+speed+of+action+of+recombinant+tissue+plasminogen+activator+in+massive+pulmonary+embolism.">Paradoxical embolus illustrating speed of action of recombinant tissue plasminogen activator in massive pulmonary embolism.</a> Emergency Medicine Journal. 24 (6), 441 (2007).</li><li>Akagi, T. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Transcatheter+closure+of+patent+foramen+ovale:+Current+evidence+and+future+perspectives.">Transcatheter closure of patent foramen ovale: Current evidence and future perspectives.</a> Journal of Cardiology. 77 (1), 3-9 (2021).</li><li>Nakayama, R., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Identification+of+high-risk+patent+foramen+ovale+associated+with+cryptogenic+stroke:+Development+of+a+scoring+system.">Identification of high-risk patent foramen ovale associated with cryptogenic stroke: Development of a scoring system.</a> Journal of the American Society of Echocardiography. 32 (7), 811-816 (2019).</li><li>Kent, D. M., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=An+index+to+identify+stroke-related+vs+incidental+patent+foramen+ovale+in+cryptogenic+stroke.">An index to identify stroke-related vs incidental patent foramen ovale in cryptogenic stroke.</a> Neurology. 81 (7), 619-625 (2013).</li><li>Diener, H. -. C., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Kryptogener+Schlaganfall+und+offenes+Foramen+ovale,+S2eLeitlinie,+2018.">Kryptogener Schlaganfall und offenes Foramen ovale, S2eLeitlinie, 2018.</a> Deutsche Gesellschaft f&#252;r Neurologie (Hrsg.), Leitlinien f&#252;r Diagnostik und Therapie in der Neurologie. , (2021).</li><li>Zanchetta, M., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Catheter+closure+of+perforated+secundum+atrial+septal+defect+under+intracardiac+echocardiographic+guidance+using+a+single+amplatzer+device:+Feasibility+of+a+new+method.">Catheter closure of perforated secundum atrial septal defect under intracardiac echocardiographic guidance using a single amplatzer device: Feasibility of a new method.</a> Journal of Invasive Cardiology. 17 (5), 262-265 (2005).</li><li>Krizanic, F., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=The+Occlutech+Figulla+PFO+and+ASD+occluder:+A+new+nitinol+wire+mesh+device+for+closure+of+atrial+septal+defects.">The Occlutech Figulla PFO and ASD occluder: A new nitinol wire mesh device for closure of atrial septal defects.</a> Journal of Invasive Cardiology. 22 (4), 182-187 (2010).</li><li>S&#248;ndergaard, L., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Patent+foramen+ovale+closure+or+antiplatelet+therapy+for+cryptogenic+stroke.">Patent foramen ovale closure or antiplatelet therapy for cryptogenic stroke.</a> New England Journal of Medicine. 377 (11), 1033-1042 (2017).</li><li>Saver, J. L., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Long-term+outcomes+of+patent+foramen+ovale+closure+or+medical+therapy+after+stroke.">Long-term outcomes of patent foramen ovale closure or medical therapy after stroke.</a> New England Journal of Medicine. 377 (11), 1022-1032 (2017).</li><li>Mas, J. -. L., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Patent+foramen+ovale+closure+or+anticoagulation+vs.+antiplatelets+after+stroke.">Patent foramen ovale closure or anticoagulation vs. antiplatelets after stroke.</a> New England Journal of Medicine. 377 (11), 1011-1021 (2017).</li><li>Furlan, A. J., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Closure+or+medical+therapy+for+cryptogenic+stroke+with+patent+foramen+ovale.">Closure or medical therapy for cryptogenic stroke with patent foramen ovale.</a> New England Journal of Medicine. 366 (11), 991-999 (2012).</li><li>Lee, P. H., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Cryptogenic+stroke+and+high-risk+patent+foramen+ovale:+The+DEFENSE-PFO+trial.">Cryptogenic stroke and high-risk patent foramen ovale: The DEFENSE-PFO trial.</a> Journal of the American College of Cardiology. 71 (20), 2335-2342 (2018).</li><li>Carroll, J. D., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Closure+of+patent+foramen+ovale+versus+medical+therapy+after+cryptogenic+stroke.">Closure of patent foramen ovale versus medical therapy after cryptogenic stroke.</a> New England Journal of Medicine. 368 (12), 1092-1100 (2013).</li><li>Lock, J. E., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Transcatheter+umbrella+closure+of+congenital+heart+defects.">Transcatheter umbrella closure of congenital heart defects.</a> Circulation. 75 (3), 593-599 (1987).</li><li>Maloku, A., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Patent+foramen+ovale-When+to+close+and+how.">Patent foramen ovale-When to close and how.</a> Herz. 46 (5), 445-451 (2021).</li><li>Meier, B., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Percutaneous+closure+of+patent+foramen+ovale+in+cryptogenic+embolism.">Percutaneous closure of patent foramen ovale in cryptogenic embolism.</a> New England Journal of Medicine. 368 (12), 1083-1091 (2013).</li><li>Vanden Branden, B. J., Post, M. C., Plokker, H. W., ten Berg, J. M., Suttorp, M. J. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Patent+foramen+ovale+closure+using+a+bioabsorbable+closure+device:+Safety+and+efficacy+at+6-month+follow-up.">Patent foramen ovale closure using a bioabsorbable closure device: Safety and efficacy at 6-month follow-up.</a> JACC Cardiovascular Interventions. 3 (9), 968-973 (2010).</li><li>Sievert, K., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Transcatheter+closure+of+atrial+septal+defect+and+patent+foramen+ovale+with+Carag+bioresorbable+septal+occluder:+First-in-man+experience+with+24-month+follow-up.">Transcatheter closure of atrial septal defect and patent foramen ovale with Carag bioresorbable septal occluder: First-in-man experience with 24-month follow-up.</a> EuroIntervention. 17 (18), 1536-1537 (2021).</li></ol>

The interventional closure of a PFO is relatively simple compared to other procedures in interventional cardiology. It is important to perform it without complications since patients are mostly young and experience no short-term benefit from the procedure due to its prophylactic nature, in contrast to potentially life-saving therapies during acute myocardial infarction.
The critical steps of the procedure from our perspective are the safe puncture of the groin to avoid bleedin...

The foramen ovale is a remnant from embryologic heart development that usually closes within a few years after birth1. Previously, a patent foramen ovale (PFO) was found in 27.3% of cases in an autopsy study of 965 normal hearts2 and in 25.6% of the 581 subjects in a transesophageal echocardiography (TEE) study3. There are no significant differences with respect to sex or race/ethnicity2,3,4, and autopsy data show that the PFO diameter in adults varies from 1 mm to 19 mm (average: 4.9 mm) and increases with age5.
In up to 25% of all ischemic stroke cases, the cause cannot be attributed to clear factors such as the atherosclerosis of large vessels, small artery disease, or cardiac embolism despite extensive vascular, serological, and cardiac evaluation, hence the designation &#34;cryptogenic stroke&#34;6,7. Venous thrombus migration, through a PFO into the arterial circulation, has been shown as a possible cause of stroke in several studies and also by the imaging of the thrombus in transit8,9. PFO can be diagnosed with transthoracic contrast echocardiography when a contrast appears in the left atrium of the heart after filling the right atrium or within three heartbeat cycles after the Valsalva maneuver is terminated. Here, the shunt can be graded using the number of bubbles appearing in the left atrium: Grade 1 (fewer than 5 bubbles), Grade 2 (6-25 bubbles), Grade 3 (25 or more bubbles), and Grade 4 (visualization of the bubbles in the entire heart chamber)10. Further, transesophageal echocardiography (TEE) is necessary to evaluate the specific PFO morphology (see Figure 1). Certain findings are associated with a higher rate of thromboembolic events. These high-risk PFOs may have a large size, the presence of an atrial aneurysm (defined as an excursion of the septal tissue of more than 10 mm from the plane of the atrial septum into the right or left atrium), a large eustachian valve, spontaneous left-to-right shunts, and hypermobility of the septum during the Valsalva maneuver11. A number of scores, such as the RoPE score12, have been established to determine the probability that a discovered PFO is pathogenic. Finally, the PFO closure procedure is recommended by current guidelines for patients with cryptogenic stroke at 16 years to 60 years of age13. A further indication of this procedure is drug-resistant migraines.
Transesophageal echocardiography is regarded as the gold standard for the diagnosis of PFO and is utilized for the procedural planning of PFO closure. This procedure is performed percutaneously in a minimally invasive fashion in a standard cardiac catheterization laboratory using fluoroscopy, TEE guidance, and physiological monitoring. Intracardiac echocardiography (ICE) may be considered as an alternative to TEE by experienced operators14.
We describe the PFO-closure procedure under TEE and fluoroscopic guidance using a double-disc device made from a Nitinol (nickel titanium) wire mesh (i.e., the PFO occluder)15, as depicted in Figure 2.

<table border="1" fo:keep-together.within-page="1" fo:keep-with-next.within-page="always">
	<tbody>
		<tr>
			<td>50 ml syringe- Perfusor syringe Luer-Lock 50 cc</td>
			<td>B. Braun</td>
			<td>8728844F</td>
			<td>Flush syringe</td>
		</tr>
		<tr>
			<td>Amplatz Super stiff Guide wire 260 cm</td>
			<td>Boston Scientific</td>
			<td>M001465021</td>
			<td>exchange wire</td>
		</tr>
		<tr>
			<td>Amplatzer Sizing ballon II 24 mm</td>
			<td>Abbott&#160;</td>
			<td>9-SB-024</td>
			<td>sizing</td>
		</tr>
		<tr>
			<td>catheter set- Angiodyn Set Uni Jena</td>
			<td>B. Braun</td>
			<td>6010111-0</td>
			<td>cover set</td>
		</tr>
		<tr>
			<td>Figulla Flex II PFO Occluder Procedure Pack</td>
			<td>Occlutech</td>
			<td>19PFO25DP</td>
			<td>various sizes available</td>
		</tr>
		<tr>
			<td>Mullins Sheat 7-11 fr.- Check Flow Performer Introducer- 9F 75 cm&#160;</td>
			<td>Cook Medical</td>
			<td>RCFW-9.0-38-75-RB-MTS</td>
			<td>delivery sheath</td>
		</tr>
		<tr>
			<td>Multi purpose catheter 5 F - Impulse MPA 1</td>
			<td>Boston scientific</td>
			<td>H749163911171</td>
			<td>atrial septal passage</td>
		</tr>
		<tr>
			<td>Sheath 4 F- Radiofocus Introducer II 4 Fr. 10 cm</td>
			<td>Terumo</td>
			<td>RS*B40K10MR</td>
			<td>arterial blood pressure measurement</td>
		</tr>
		<tr>
			<td>Sheath 7-11 Fr- Radiofucus Introducer II 9 F 10 cm</td>
			<td>Terumo</td>
			<td>RS*B90N10MRD</td>
			<td>Device Loading</td>
		</tr>
	</tbody>
</table>

closure of a patent foramen ovale (pfo): an intervention sequence

A patent foramen ovale (PFO) persists in about one-quarter of people and is the source of up to 25% of all ischemic strokes, especially strokes in young adults. PFO can be easily diagnosed by transthoracic contrast and/or transesophageal echocardiography. Interventional closure of the PFO via the femoral vein is a commonly used cardiological procedure since several trials have demonstrated the superiority of PFO closure over standard medical therapy in patients with PFO and who have experienced post ischemic, cardioembolic, or cryptogenic stroke. The current paper and video show the procedure of PFO closure in a step-by-step manner.

In this study, the closure of a PFO was successfully performed. The Live echo was able to show the closure of the interatrial septum without residual shunt with the utilized device (see the Table of Materials). The control of the placement of the interatrial septum between the left and the right discs of the device is important to guarantee the stability of the device, and this is checked by TEE in several planes before the release of the device. The device lays smoothly on the interatrial septum without...

Watch this Scientific Journal Video about Closure of a Patent Foramen Ovale PFO: An Intervention Sequence at JoVE.com

Closure of a Patent Foramen Ovale PFO: An Intervention Sequence

The closure of a patent foramen ovale (PFO) is a catheter-based intervention to prevent PFO-associated stroke. The PFO-occlusion device is advanced through the femoral vein and deployed across the interatrial septum using transesophageal echocardiography (TEE) and fluoroscopic guidance. The following protocol provides a step-by-step guide for the PFO-closure intervention using a double-disc device.

Closure of a Patent Foramen Ovale (PFO): An Intervention Sequence

A patent foramen ovale (PFO) persists in about one-quarter of people and is the source of up to 25% of all ischemic strokes, especially strokes in young ...

This protocol helps to learn all the steps for the standardized procedure for interventional closure of the PFO. We show a standardized technique that is safe and feasible and allows to close nearly every PFO. To begin, establish a peripheral venous access line and connect to 500 CC of sodium chloride, then fix the arms and legs of the patient.Initiate the ECG, peripheral oxygen saturation and pulse measurements. Perform sterilization of the right groin using an iodine-based solution. Prepare sterile equipment with the materials required by the catheter assistant or nurse.Cover the sterilized femoral access site with a transparent foil plaster. Apply local anesthesia to the oropharyngeal region five to 10 times, then apply bite protection. Prepare ultrasound guidance under sterile conditions.Access the right femoral vein through palpation, fluoroscopic, or ultrasound guidance. Provide subcutaneous anesthesia. Perform the venous puncture of the groin.Then introduce a standard wire with a J-Tip and a five French multipurpose catheter into the superior vena cava. Perform an arterial puncture of the femoral artery and introduce a four French sheath for pressure monitoring. Many interventional cardiologists may find non-invasive blood pressure monitoring reliable in stable patients or use a radial access.Once the arterial blood pressure measurement is established, start the conscious sedation of the patient with midazolam and propofol as described in the text manuscript. Measure the pressure in the right atrium. The CVP should be in a normal range of around six to 12 millimeters of mercury.If the main CVP is lower, give a sodium chloride infusion until the CVP reaches a minimum of six millimeters of mercury to avoid air embolism during the procedure. Introduce the TEE probe and assess possible preexisting pericardial effusion in a four-chamber view and set the bicaval view to include the PFO. Advance, a J-Tip standard wire and the multipurpose catheter into the left atrium by slightly pushing forward the wire and placing it in the left upper pulmonary vein under fluoroscopy and TEE guidance.Obtain optimal TEE imaging by sweeping from 30 degree to 110 degree. Obtain a 45-degree left anterior oblique view as this may be helpful. Once the catheter is introduced into the left atrium, administer a bolus injection of 100 IU heparin per kilogram body weight to reach an activated clotting time of around 250 seconds.The activated clotting time should be controlled after around five minutes by a point-of-care ACT analyzer. Measure the left atrial pressure via the multipurpose catheter. If it is below five millimeters of mercury, administer IV fluid to reach a mean left atrial pressure of five to 10 millimeters of mercury.Advance a stiff, long guide wire with a soft tip along the catheter into the left atrium, targeting the upper pulmonary vein. Then deair the balloon carefully with one-fourth to two-fourth contrast dye and saline mix outside the patient. Exchange the multipurpose catheter for a 24-millimeter sizing balloon.Position the balloon across the PFO and inflate it with a 0.9%sodium chloride in the contrast agent solution in a three-to-one ratio. Use two perpendicular TEE projections for the PFO measurement. Confirm the dimensions by angiography images.In both cases, the measurement of the smallest balloon tail is crucial. Use a sizing chart to select the size and type of the PFO-occluded device using the PFO size and total septum length assessed by TEE or TTE according to the manufacturer's instructions. Prepare an adequately-sized closure device as described in the text manuscript.And flush properly to eliminate air bubbles. Deflate the sizing balloon and exchange it for the delivery sheath. Introduce the delivery sheath via the stiff guide wire.Then remove the introducer and wire. After the aspiration of blood, ensure a wet-to-wet connection between the sheath and the PFO closure device to guarantee air bubble-free advancement of the device. Introduce the closure device through the sheath via a wet-to-wet connection by flushing saline through the side port and ensuring back bleeding from the sheath.Then push the device forward into the sheath. Once the device is visible within the sheath, observe if there is no air bubble in front of the device. Then pull the device back approximately two centimeters to confirm the attachment of the device to the delivery cable.Push the device forward into the left atrium and carefully retract the sheath into the mid-left atrium in a push and pull movement and the echocardiographic guidance, which allows the left-sided disc to unfold. Here, TEE guidance, instead of angiography, is sufficient and recommended to reduce the radiation dose. We draw the left-sided disc toward the interatrial septum until a subtle resistance is felt and the left-sided disc is seen on the septum by TEE.Under discreet tension, pull the sheath back into the right atrium, expanding the right-sided disc. Push the device gently against the interatrial septum until the discs attach. Assess the correct position of the closure device with TEE and angiography.With the latter, the Pacman sign indicates the correct device placement. Inspect the edges of the device thoroughly for any misalignments concerning the aorta or the roof of the left atrium, which may lead to localized compression damage. A push-pull tug test can help to show the stability of the device.Once the position of the device is correct, disconnect the delivery cable and remove the sheath. Close the femoral vein with the resorbing suture using a figure of eight stitch of the subcutaneous tissue material or a vessel closure device. Use a tight-sitting pressure bandage to prevent local bleeding.After removing the arterial blood pressure monitoring device, perform manual compression of the common femoral artery or use a closure device followed by applying a tight bandage. Continue non-invasive monitoring of the blood pressure and heart rate for 24 hours. Provide heparin for 24 hours as described in the text manuscript.In young patients, less than 65 years old, a lower risk for recurrent strokes and mortality was observed after interventional PFO closure compared to medical therapy only. Peri-interventional complications in PFO closure were rare. Pericardial tamponade rarely occurred in the RESPECT and REDUCE trials at a rate of 0.4 and 0.2%respectively.Cardiac perforation was a severe complication that occurred in 0.25%of patients in the CLOSURE-I trial and 0.2%in the RESPECT trial. It is crucial that the device opening and positioning is done under TEE control to obtain the best possible result. If TEE is unavailable, the device position can also be checked by contrast dye injection.

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Medicine

The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation

Atrial fibrillation (AF) is the most common cardiac arrhythmia, affecting an estimated 6 million people in the United States 1. Since AF affects primarily elderly people, its prevalence increases parallel with age. As such, it is expected that 15.9 million Americans will be affected by the year 2050 2. Ischemic stroke occurs in 5% of non-anticoagulated AF patients each year. Current treatments for AF include rate control, rhythm control and prevention of stroke 3.
The American College of Cardiology, American Heart Association, and European Society of Cardiology currently recommended rate control as the first course of therapy for AF 3. Rate control is achieved by administration of pharmacological agents, such as &beta;-blockers, that lower the heart rate until it reaches a less symptomatic state 3. Rhythm control aims to return the heart to its normal sinus rhythm and is typically achieved through administration of antiarrhythmic drugs such as amiodarone, electrical cardioversion or ablation therapy. Rhythm control methods, however, have not been demonstrated to be superior to rate-control methods 4-6. In fact, certain antiarrhythmic drugs have been shown to be associated with higher hospitalization rates, serious adverse effects 3, or even increases in mortality in patients with structural heart defects 7. Thus, treatment with antiarrhythmics is more often used when rate-control drugs are ineffective or contraindicated. Rate-control and antiarrhythmic agents relieve the symptoms of AF, including palpitations, shortness of breath, and fatigue 8, but don't reliably prevent thromboembolic events 6.
Treatment with the anticoagulant drug warfarin significantly reduces the rate of stroke or embolism 9,10. However, because of problems associated with its use, fewer than 50% of patients are treated with it. The therapeutic dose is affected by drug, dietary, and metabolic interactions, and thus requires detailed monitoring. In addition, warfarin has the potential to cause severe, sometimes lethal, bleeding 2. As an alternative, aspirin is commonly prescribed. While aspirin is typically well tolerated, it is far less effective at preventing stroke 10. Other alternatives to warfarin, such as dabigatran 11 or rivaroxaban 12 demonstrate non-inferiority to warfarin with respect to thromboembolic events (in fact, dabigatran given as a high dose of 150 mg twice a day has shown superiority). While these drugs have the advantage of eliminating dietary concerns and eliminating the need for regular blood monitoring, major bleeding and associated complications, while somewhat less so than with warfarin, remain an issue 13-15.
Since 90% of AF-associated strokes result from emboli that arise from the left atrial appendage (LAA) 2, one alternative approach to warfarin therapy has been to exclude the LAA using an implanted device to trap blood clots before they exit. Here, we demonstrate a procedure for implanting the WATCHMAN Left Atrial Appendage Closure Device. A transseptal cannula is inserted through the femoral vein, and under fluoroscopic guidance, inter-atrial septum is crossed. Once access to the left atrium has been achieved, a guidewire is placed in the upper pulmonary vein and the WATCHMAN Access Sheath and dilator are advanced over the wire into the left atrium. The guidewire is removed, and the access sheath is carefully advanced into the distal portion of the LAA over a pigtail catheter. The WATCHMAN Delivery System is prepped, inserted into the access sheath, and slowly advanced. The WATCHMAN device is then deployed into the LAA. The device release criteria are confirmed via fluoroscopy and transesophageal echocardiography (TEE) and the device is released.

The accompanying video describes a procedure for percutaneous placement of the WATCHMAN Left Atrial Appendage (LAA) Device. The WATCHMAN is a nitinol device designed to be permanently implanted at, or slightly distal to, the opening of the left atrial appendage (LAA) to trap blood clots before they exit the LAA, preventing thromboembolic stroke.

Atrial fibrillation (AF) is the most common cardiac arrhythmia, affecting an estimated 6 million people in the United States 1. Since AF affects primarily ...

Catheter Ablation in Combination With Left Atrial Appendage Closure for Atrial Fibrillation

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia, affecting millions of individuals worldwide 1-3. The rapid, irregular, and disordered electrical activity in the atria gives rise to palpitations, fatigue, dyspnea, chest pain and dizziness with or without syncope 4, 5. Patients with AF have a five-fold higher risk of stroke 6.
Oral anticoagulation (OAC) with warfarin is commonly used for stroke prevention in patients with AF and has been shown to reduce the risk of stroke by 64% 7. Warfarin therapy has several major disadvantages, however, including bleeding, non-tolerance, interactions with other medications and foods, non-compliance and a narrow therapeutic range 8-11. These issues, together with poor appreciation of the risk-benefit ratio, unawareness of guidelines, or absence of an OAC monitoring outpatient clinic may explain why only 30-60% of patients with AF are prescribed this drug 8.
The problems associated with warfarin, combined with the limited efficacy and/or serious side effects associated with other medications used for AF 12,13, highlight the need for effective non-pharmacological approaches to treatment. One such approach is catheter ablation (CA), a procedure in which a radiofrequency electrical current is applied to regions of the heart to create small ablation lesions that electrically isolate potential AF triggers 4. CA is a well-established treatment for AF symptoms 14, 15, that may also decrease the risk of stroke. Recent data showed a significant decrease in the relative risk of stroke and transient ischemic attack events among patients who underwent ablation compared with those undergoing antiarrhythmic drug therapy 16.
Since the left atrial appendage (LAA) is the source of thrombi in more than 90% of patients with non-valvular atrial fibrillation 17, another approach to stroke prevention is to physically block clots from exiting the LAA. One method for occluding the LAA is via percutaneous placement of the WATCHMAN LAA closure device. The WATCHMAN device resembles a small parachute. It consists of a nitinol frame covered by fabric polyethyl terephthalate that prevents emboli, but not blood, from exiting during the healing process. Fixation anchors around the perimeter secure the device in the LAA (Figure 1). To date, the WATCHMAN is the only implanted percutaneous device for which a randomized clinical trial has been reported. In this study, implantation of the WATCHMAN was found to be at least as effective as warfarin in preventing stroke (all-causes) and death (all-causes) 18. This device received the Conformit&eacute; Europ&eacute;enne (CE) mark for use in the European Union for warfarin eligible patients and in those who have a contraindication to anticoagulation therapy 19.
Given the proven effectiveness of CA to alleviate AF symptoms and the promising data with regard to reduction of thromboembolic events with both CA and WATCHMAN implantation, combining the two procedures is hoped to further reduce the incidence of stroke in high-risk patients while simultaneously relieving symptoms. The combined procedure may eventually enable patients to undergo implantation of the WATCHMAN device without subsequent warfarin treatment, since the CA procedure itself reduces thromboembolic events. This would present an avenue of treatment previously unavailable to patients ineligible for warfarin treatment because of recurrent bleeding 20 or other warfarin-associated problems.
The combined procedure is performed under general anesthesia with biplane fluoroscopy and TEE guidance. Catheter ablation is followed by implantation of the WATCHMAN LAA closure device. Data from a non-randomized trial with 10 patients demonstrates that this procedure can be safely performed in patients with a CHADS2 score of greater than 1 21. Further studies to examine the effectiveness of the combined procedure in reducing symptoms from AF and associated stroke are therefore warranted.

Catheter ablation is combined with placement of the WATCHMAN Left Atrial Appendage Closure Device to prevent ischemic stroke in a patient with non-valvular atrial fibrillation.

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia, affecting millions of individuals worldwide 1-3. The rapid, irregular, and ...

Using Quantitative Real-time PCR to Determine Donor Cell Engraftment in a Competitive Murine Bone Marrow Transplantation Model

Murine bone marrow transplantation models provide an important tool in measuring hematopoietic stem cell (HSC) functions and determining genes/molecules that regulate HSCs. In these transplant model systems, the function of HSCs is determined by the ability of these cells to engraft and reconstitute lethally irradiated recipient mice. Commonly, the donor cell contribution/engraftment is measured by antibodies to donor- specific cell surface proteins using flow cytometry. However, this method heavily depends on the specificity and the ability of the cell surface marker to differentiate donor-derived cells from recipient-originated cells, which may not be available for all mouse strains. Considering the various backgrounds of genetically modified mouse strains in the market, this cell surface/ flow cytometry-based method has significant limitations especially in mouse strains that lack well-defined surface markers to separate donor cells from congenic recipient cells. Here, we reported a PCR-based technique to determine donor cell engraftment/contribution in transplant recipient mice. We transplanted male donor bone marrow HSCs to lethally irradiated congenic female mice. Peripheral blood samples were collected at different time points post transplantation. Bone marrow samples were obtained at the end of the experiments. Genomic DNA was isolated and the Y chromosome specific gene, Zfy1, was amplified using quantitative Real time PCR. The engraftment of male donor-derived cells in the female recipient mice was calculated against standard curve with known percentage of male vs. female DNAs. Bcl2 was used as a reference gene to normalize the total DNA amount. Our data suggested that this approach reliably determines donor cell engraftment and provides a useful, yet simple method in measuring hematopoietic cell reconstitution in murine bone marrow transplantation models. Our method can be routinely performed in most laboratories because no costly equipment such as flow cytometry is required.

Determining donor cell engraftment presents a challenge in mouse bone marrow transplant models that lack well-defined phenotypical markers. We described a methodology to quantify male donor cell engraftment in female transplant recipient mice. This method can be used in all mouse strains for the study of HSC functions.

Murine bone marrow transplantation models provide an important tool in measuring hematopoietic stem cell (HSC) functions and determining genes/molecules ...

A Possible Zebrafish Model of Polycystic Kidney Disease: Knockdown of wnt5a Causes Cysts in Zebrafish Kidneys

Polycystic kidney disease (PKD) is one of the most common causes of end-stage kidney disease, a devastating disease for which there is no cure. The molecular mechanisms leading to cyst formation in PKD remain somewhat unclear, but many genes are thought to be involved. Wnt5a is a non-canonical glycoprotein that regulates a wide range of developmental processes. Wnt5a works through the planar cell polarity (PCP) pathway that regulates oriented cell division during renal tubular cell elongation. Defects of the PCP pathway have been found to cause kidney cyst formation. Our paper describes a method for developing a zebrafish cystic kidney disease model by knockdown of the wnt5a gene with wnt5a antisense morpholino (MO) oligonucleotides. Tg(wt1b:GFP) transgenic zebrafish were used to visualize kidney structure and kidney cysts following wnt5a knockdown. Two distinct antisense MOs (AUG - and splice-site) were used and both resulted in curly tail down phenotype and cyst formation after wnt5a knockdown. Injection of mouse Wnt5a mRNA, resistant to the MOs due to a difference in primary base pair structure, rescued the abnormal phenotype, demonstrating that the phenotype was not due to &#8220;off-target&#8221; effects of the morpholino. This work supports the validity of using a zebrafish model to study wnt5a function in the kidney.

A Possible Zebrafish Model of Polycystic Kidney Disease: Knockdown of wnt5a Causes Cysts in Zebrafish Kidneys

We describe a method of generating a possible zebrafish model of polycystic kidney disease. We used Tg(wt1b:GFP) fish to visualize kidney structure. Knockdown of wnt5a was by morpholino injection. Pronephric cyst formation after wnt5a knockdown was observed in this GFP transgenic zebrafish.

Polycystic kidney disease (PKD) is one of the most common causes of end-stage kidney disease, a devastating disease for which there is no cure. The ...

Network Analysis of Foramen Ovale Electrode Recordings in Drug-resistant Temporal Lobe Epilepsy Patients

Approximately 30% of epilepsy patients are refractory to antiepileptic drugs. In these cases, surgery is the only alternative to eliminate/control seizures. However, a significant minority of patients continues to exhibit post-operative seizures, even in those cases in which the suspected source of seizures has been correctly localized and resected. The protocol presented here combines a clinical procedure routinely employed during the pre-operative evaluation of temporal lobe epilepsy (TLE) patients with a novel technique for network analysis. The method allows for the evaluation of the temporal evolution of mesial network parameters. The bilateral insertion of foramen ovale electrodes (FOE) into the ambient cistern simultaneously records electrocortical activity at several mesial areas in the temporal lobe. Furthermore, network methodology applied to the recorded time series tracks the temporal evolution of the mesial networks both interictally and during the seizures. In this way, the presented protocol offers a unique way to visualize and quantify measures that considers the relationships between several mesial areas instead of a single area.

This protocol describes a procedure to track the evolution of mesial network measures in temporal lobe epilepsy (TLE) patients. It is based on the combination of intracranial recordings with a novel numerical technique for data analysis. Specifically, we present a protocol for network analyses of foramen ovale recordings.

Approximately 30% of epilepsy patients are refractory to antiepileptic drugs. In these cases, surgery is the only alternative to eliminate/control ...

A Case Series of Successful Abdominal Closure Utilizing a Novel Technique Combining a Mechanical Closure System with a Biologic Xenograft that Accelerates Wound Healing

In the acute setting, once intra-abdominal injuries have been addressed, the next great hurdle is restoring a functional and intact abdominal compartment. The short and long-term consequences of living with a chronically open abdominal compartment include pulmonary, musculoskeletal, gastrointestinal, and emotional disability. The closure of catastrophic open abdomens presents a challenge to the surgeon. We present a technique utilizing a mechanical abdominal closure device in conjunction with biologic xenograft in closing complex open abdomens. This technique offers another option for definitive fascial closure and accelerated wound healing in this difficult patient population. The dynamic tissue system (DTS) is installed after control of original intraabdominal pathology. A porcine urinary bladder matrix (PUBM) is then placed in the subcutaneous space once fascial closure is achieved. Overall, primary myofascial closure was achieved in 100% of patients at a mean of 9.36 days.

Closure of catastrophic open abdominal wounds presents a challenge to the surgeon. We present a surgical technique utilizing a combination of mechanical and biologic xenograft closure systems in closing complex open abdominal wounds. This technique offers another option to the surgeon for definitive fascial closure and accelerated wound healing.

In the acute setting, once intra-abdominal injuries have been addressed, the next great hurdle is restoring a functional and intact abdominal compartment. ...

Echocardiographic Evaluation of Atrial Communications before Transcatheter Closure

Transthoracic (TTE) and transesophageal echocardiography (TEE) is the standard imaging method for atrial septal defect (ASD) and patent foramen ovale (PFO) detection, for patient selection for transcatheter ASD/PFO closure,&#160;for intraoperative guidance and for long-term follow-up. The size, shape, location and the number of the atrial communications schould be determined. The accuracy of PFO detection can be improved by using agitated saline together with maneuvers to transiently increase the right atrial (RA) pressure. The appearance of microbubbles in the left atrium (LA) within 3 cardiac cycles after opacification of the RA is considered positive for the presence of an intracardiac shunt. Three dimensional TEE identifies further septal fenestrations and describes the dynamic morphology of ASD/PFO and atrial septal aneurysm. Follow-up evaluations with TTE is recommended at 1, 6, and 12 months after the procedure, with a subsequent evaluation every year. Previous studies showed an increased incidence of atrial arrhythmias early after device closure. Speckle tracking analysis may help to understand functional left atrial remodeling following percutaneous closure and its impact on atrial arrhythmias.

Transthoracic (TTE) and transesophageal (TEE) echocardiography represent the basic imaging tools for interatrial septum examination. Three dimensional (3D) TEE provides incremental information in the assessment of the interatrial septum. Further advanced echocardiography techniques using speckle tracking echocardiography are applied for sensitive volumetric and functional assessment of the heart chambers.&#160;

Transthoracic (TTE) and transesophageal echocardiography (TEE) is the standard imaging method for atrial septal defect (ASD) and patent foramen ovale ...

Preparation of a Non-Cardiomyocyte Cell Suspension for Single-Cell RNA Sequencing from a Post-Myocardial Infarction Adult Mouse Heart

Myocardial infarction (MI) is one of the most common cardiovascular diseases, with increasing mortality worldwide. Non-cardiomyocytes account for more than half of the total cardiac cell population, and they contribute to adaptive compensations upon myocardial injury, including inflammatory responses, tissue repair, and scar formation. To study the post-MI cardiac microenvironment, single-cell RNA sequencing (scRNA-seq) is widely used to identify different cardiac cell types and intercellular communications. Among the procedures of scRNA-seq sample preparation, preparing the cell suspension is one of the most critical steps, because the cell viability can affect the quality of the scRNA-seq results. Therefore, we designed an experimental protocol for preparing a non-cardiomyocyte cell suspension from post-MI mouse hearts with an extra focus on improving the cell viability by choosing mild digestive enzymes, controlling the digestion time, and applying fluorescence-activated cell sorting (FACS). Finally, we isolated CD45+ cells from the non-cardiomyocyte cell suspension obtained through this protocol, and then we performed scRNA-seq.

Here, we describe a protocol to isolate a sufficient amount of single non-cardiomyocytes with high viability from a post-myocardial infarction (MI) mouse heart. This can be used for subsequent single-cell sequencing, flow cytometry analysis, and primary cell culture.

Myocardial infarction (MI) is one of the most common cardiovascular diseases, with increasing mortality worldwide. Non-cardiomyocytes account for more ...

3D Printing Model of a Patient's Specific Lumbar Vertebra

Selective dorsal rhizotomy (SDR) is a difficult, risky, and sophisticated operation, in which a laminectomy should not only expose an adequate surgical field of view but also protect the patient&#39;s spinal nerves from injury. Digital models play an important role in the pre-and intra-operation of SDR, because they can not only make doctors more familiar with the anatomical structure of the surgical site, but also provide precise surgical navigation coordinates for the manipulator. This study aims to create a 3D digital model of a patient-specific lumbar vertebra that can be used for planning, surgical navigation, and training of the SDR operation. The 3D printing model is also manufactured for more effective work during these processes.
Traditional orthopedic digital models rely almost entirely on computed tomography (CT) data, which is less sensitive to soft tissues. Fusion of the bone structure from CT and the neural structure from magnetic resonance imaging (MRI) is the key element for the model reconstruction in this study. The patient&#39;s specific 3D digital model is reconstructed for the real appearance of the surgical area and shows the accurate measurement of inter-structural distances and regional segmentation, which can effectively help in the preoperative planning and training of SDR. The transparent bone structure material of the 3D-printed model allows surgeons to clearly distinguish the relative relationship between the spinal nerve and the vertebral plate of the operated segment, enhancing their anatomical understanding and spatial sense of the structure. The advantages of the individualized 3D digital model and its accurate relationship between spinal nerve and bone structures make this method a good choice for preoperative planning of SDR surgery.

3D Printing Model of a Patient&#039;s Specific Lumbar Vertebra

This study aims to create a 3D-printed model of a patient-specific lumbar vertebra, which contains both the vertebra and spinal nerve models fused from high-resolution computed tomography (HRCT) and MRI-Dixon data.

Selective dorsal rhizotomy (SDR) is a difficult, risky, and sophisticated operation, in which a laminectomy should not only expose an adequate surgical ...

In Vitro Application of a Wireless Sensor in Flexion-Extension Gap Balance of Unicompartmental Knee Arthroplasty

Unicompartmental knee arthroplasty (UKA) is an effective treatment for end-stage anteromedial osteoarthritis (AMOA). The key to UKA is the flexion-extension gap balance, which is closely related to postoperative complications such as bearing dislocation, bearing wear, and arthritis progression. The traditional gap balance assessment is performed by indirectly sensing the tension of the medial collateral ligament by a gap gauge. It relies on the surgeon's feel and experience, which is imprecise and difficult for beginners. To accurately assess the flexion-extension gap balance of UKA, we developed a wireless sensor combination consisting of a metal base, a pressure sensor, and a cushion block. After osteotomy, the insertion of a wireless sensor combination allows the real-time measurement of intra-articular pressure. It accurately quantifies the flexion-extension gap balance parameters to guide further femur grinding and tibia osteotomy, to improve the accuracy of gap balance. We conducted an in vitro experiment with the wireless sensor combination. the results showed that there was a difference of 11.3 N after applying the traditional method of flexion-extension gap balance performed by an experienced expert.

In Vitro Application of a Wireless Sensor in Flexion-Extension Gap Balance of Unicompartmental Knee Arthroplasty

This protocol presents a cadaveric study of a wireless sensor used in medial unicompartmental knee arthroplasty. The protocol includes the installation of an angle measuring device, standardized Oxford unicompartmental knee arthroplasty osteotomy, preliminary assessment of flexion-extension balance, and application of the sensor to measure flexion-extension gap pressure.