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Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_3737_Библиотеки_им_академика_М_И_Перельмана

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is rapid and complete whiteout of the left sided chambers. To augment venous return and thus accentuate the opening of the PFO, a Valsalva maneuver or cough can be helpful to reveal PFOs that at rest may not be apparent.
The timing of bubble arrival on the left side can be used to delineate whether the shunt is truly intra-cardiac. It is thought that bubbles arriving later (>6 beats after arrival on the right side) may represent extracardiac shunting. However, there may be exceptions to this such as low cardiac out­put states, Valsalva (which during the strain phase lowers venous return), deep inspiration or cough [5]. Alternatively, if the source of bubbles seen on the left side can be ascertained (emanating from a pulmonary vein vs. emanating from the interatrial septum), then this can be used in lieu of the num­ber of beats to differentiate intracardiac vs. extra­cardiac shunting. Then, certain anatomic features can help identify higher risk features such as atrial septal aneurysms (Fig. 2), Chiari networks and prominent Eustachian ridges (Fig.3) [6, 7].
Given the presence of intracardiac shunting on TTE, a TEE is performed for the purpose of iden­tifying high risk features associated with crypto­genic stroke and whether challenges for device closure may be present. Challenges to percutane­ous closure include: redundant tissue, fenestra­tions, thicker/lipomatous septum secundum, small retroaortic rim, the presence of chiari net­works and atypical pulmonary vein anatomy. Of note, PFO size is typically measured by TEE in its maximum diameter with color ow Doppler (Fig.4), however, this underestimates defect size
relative to sizing balloon because PFOs typically remain closed during imaging and gentle ina­tion with a sizing balloon more closely approxi­mates the PFOs true shape and size [8]. On TEE with color doppler, there is intermittent ow across the PFO (Fig.5). A small shunt is seen on TEE bubble study (Fig. 6 and Video 2) no Valsalva is performed. TEE will typically underestimate the degree of shunting due to the effect of sedation on degree of shunting and its effect on lling pressures and provocative maneu­vers. As a result, we primarily use TTE for the assessment of the degree of shunting while rely­ing on TEE to visualize the PFO and detect atrial septal aneurysm. No other intra-cardiac thrombi are noted on the TEE.No atrial septal aneurysm was identied, the retro-aortic rim was >5mm and the septum secundum appeared to be of nor­mal thickness. The Eustachian ridge was promi­nent, but no Chiari networks were seen. Assuming four pulmonary veins, the pulmonary veins were all seen and noted to connect to the left atrium. There were no fenestrations noted in the inter­atrial septum and there was a clear tunnel that measured about 10mm (measured as the length of overlap between the ap and the septum secun­dum). No aortic dilation was noted (Video 3).
Given the high likelihood of PFO (rather than a true atrial septal defect), consideration was given to directly proceeding with PFO closure and intra­cardiac echocardiography at the time of the proce­dure and forgoing preprocedural TEE.However, our institutional operator preference is to under­take pre-procedure TEE to not only ensure the cor-
Fig. 2 Transesophageal image of interatrial septum demonstrating interatrial septal aneurysm with bowing of the septum toward the left atrium. LA left atrium; IASA interatrial septal aneurysm; RA right atrium
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Fig. 3 Transesophageal image of prominent Eustachian ridge. LA left atrium; RA right atrium
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Fig. 4 Intracardiac echo image of interatrial septum with color Doppler over patent foramen ovale, and maximum diameter measured
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rect defect is identied but also for device selection purposes. There have been cases where a PFO was suspected but during the procedure, a complex fenestrated defect was found or a secundum ASD was found, which can dramatically change the procedural plan and device selection. Additionally, TEE has increased sensitivity for other potential sources of cardiac emboli such as left atrial or ven­tricular thrombi, myxoma, papillary broelas-
toma, endocarditis and Lamble’s excrescence. Lastly, the in-hospital evaluation for mechanism is often incomplete for many reasons. There is rarely sufcient length of telemetry monitoring to rule out paroxysmal atrial brillation and thrombo­philia workups are delayed in the setting of acute clot as well and are often not back prior to dis­charge. For these reasons, closure during the index hospitalization is rare.
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Fig. 5 (a) TEE bicaval view of PFO on the left image and (b) TEE bicaval view of PFO with color Doppler on right image showing resting right to left shunt
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Fig. 6 Transesophageal echocardiogram of interatrial septum obtained in mid esophagus in 2 orthogonal planes
ASD: For secundum atrial septal defects (Video 4) in particular, pre-procedure imaging plays an important role in determining whether a defect is appropriate for trans-catheter clo­sure. Our practice is to obtain 3D TEE mea­surements of the defect as this has been shown to correlate closely with 2D balloon sizing (Fig.7). Additionally, even large defects (up to 44 mm) have been closed with transcatheter techniques, particularly if the defect is oval with a shorter minor axis and adequate rims.
During pre- procedure assessment of secun­dum ASDs, important issues to pay attention to are ensuring all four pulmonary veins are visualized as there is an association of partial anomalous pulmonary venous return with secundum ASDs. A sinus venosus defect can be seen in the midesophageal bicaval (120°) view. Ideally, rims should be visualized (as discussed in the intra-procedural guidance section). The degree of mitral regurgitation should be assessed as post-ASD closure, this
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Fig. 7 3D rendering of atrial septal defect with orthogonal B-mode image slices in top 2 panels and short axis of atrial septal defect measured in bottom left panel
can increase due to the increase in left sided volumes and can worsen significant mitral valve disease.
Cross sectional imaging (gated cardiac CT and MRI) is not particularly helpful in evaluation of PFOs but can be helpful in understanding the three-dimensional anatomy of atrial septal defects as well as investigating congenital anom­alies associated with them. This can be particu­larly useful in the identication of complex ASDs that may require multiple devices or lead to sig­nicant interaction with surrounding cardiac structures, such that surgical closure might be more effective and safer. While CT has superior spatial resolution and can be used to plan for clo­sure with virtual placement of devices as well as 3D printing of complex defects to assist with case planning, MRI can be used for these purposes as well as hemodynamic evaluation of ASDs through calculation of cardiac output, shunt frac­tions, and Qp/QS via phase contrast imaging.
Anatomically precise 3D reconstructions of ASD anatomy through pre-procedure cross-sectional imaging have also allowed for increasing use of intraprocedural intra-cardiac echocardiography rather than TEE for guidance of closure. Overall, specically for the purposes of initial PFO and ASD evaluation, echocardiography in its various forms remains the mainstay of diagnostic evalua­tion as well as procedural guidance during percu­taneous closure procedures.
PFO: Importantly, two main scores assessing the likelihood that a cryptogenic stroke was due to a PFO have been developed. The initial Risk of Paradoxical Embolism (RoPE) score was devel­oped and internally validated from 3023 patients in 12 combined databases of patients with cryp­togenic stroke [9]. The resulting parsimonious bedside model incorporates six features of patient history and demographics to determine stroke relatedness to the PFO with a small observational study indicating a cutpoint of 7 (PFO-attributable
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stroke was 0% [95% CI 0–7.5] for RoPE <7 and
71.1% [95% CI: 35–87.3] for ROPE >7). The model has subsequently been validated for the relative risk reduction of device vs. medical ther­apy [10]. Importantly, the RoPE score does not take into account known “high risk” features of PFOs, including atrial septal aneurysm (dened as 10mm excursion of the atrial septum from the midline) or hemodynamic consequence (large shunt was dened as >20 bubbles in the left atrium on TEE). The PASCAL classication sys­tem combines the ROPE score with presence or absence of these high-risk features and was derived and validated from a cohort of 3740 patients in six randomized clinical trials of PFO closure plus medical therapy versus PFO closure alone in patients aged 18–60. The PFO­Associated Stroke Causal Likelihood (PASCAL) Classication System improved upon the ROPE score’s ability to discriminate those that were most likely to benet from PFO closure, indicat­ing the potential importance of high-risk imaging features in determining the potential benet that may be derived from percutaneous PFO closure.
Heart Team Approach andDiscussion
The patient was seen in the multi-disciplinary PFO/stroke clinic to discuss the etiology of her stroke as well as management options. Vascular neurology reviewed her brain imaging and agreed that the location of the stroke as typical of a cardio- embolic stroke and she had no other com­pelling data to suggest an alternative cause such as vasculitis, early atherosclerosis, a hypertensive stroke or that there was an arterial hypercoagula­ble state that may have contributed. Her RoPE [9,
10] score was calculated at eight and her PASCAL
classication [11] was probable given RoPE score of 8 and presence of a large shunt. Taken together, these scores suggests that (1) there is an increased likelihood of her stroke being “PFO­related” and (2) she would derive substantial reduction in recurrent stroke rate with PFO clo­sure and a low risk of peri-procedural atrial bril­lation. Given this, it was felt reasonable to
proceed with closure of the patent foramen ovale to decrease her risk of recurrent stroke with a lower risk of peri-procedure atrial brillation.
The interventional cardiologist then met with the patient to discuss percutaneous closure vs. medical management. At this point, given the variety of percutaneous closure devices available as well as the clinical trial data in support of per­cutaneous PFO closure over antithrombotic or anticoagulant therapy, surgical closure of PFOs is rarely appropriate. The patient and interventional cardiologist discussed the compelling data sup­porting that the patient experienced a stroke due to paradoxical embolization via the patent fora­men ovale was probable. The options of anti­platelet therapy alone or anticoagulation were discussed as part of a shared decision-making process. Given the patients young age and poten­tial for future pregnancies as well as desire to not be on life-long anticoagulation, percutaneous PFO closure was decided upon.
The role of medical therapy in PFO is minimal in patients otherwise deemed appropriate for PFO closure. Current guidelines recommend against anti-thrombotic or anti-coagulation ther­apy instead of PFO closure in patients with PFO related stroke [12]. RESPECT [13] and REDUCE [14, 15] led to the approval of the two currently commercially available devices based on their long-term results. Specically, in longer-term follow up, it was shown that PFO closure reduced the rate of recurrent ischemic strokes. It was a patient-level data meta-analysis [16] that have led to a understanding of the treatment effect with a relative risk of recurrent stroke of 0.42. This and many other similar meta-analyses led to the eventual shift from the term “cryptogenic stroke in the presence of a PFO” to “PFO-related stroke”. Additionally, this meta-analysis showed that there was an increased risk of atrial brilla­tion with device closure. Though no RCT exists, this data has been extended to cover peripheral paradoxical embolization as well.
The other clear indication for PFO closure is hypoxemia with exertion or upright position that cannot be explained by another etiology, platypnea- orthodeoxia syndrome. The mecha­nism is with upright or standing position, intra-
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thoracic and intracardiac conditions cause a PFO to be in an open position, and shunting across the PFO increases, leading to systemic hypoxemia and dyspnea. This is typically also caused by abnormalities that cause the PFO to be deformed such that it is opened to a greater degree or “slides” open; for example: aortic aneurysm, atrial enlargement, paralyzed hemi-diaphragm or mediastinal shifting. Other conditions that lead to increase right atrial pressures may also cause increased right to left shunting via the PFO [17,
18]. In our experience, these shunts are often
massive on TTE and if only a small shunt is noted, one should question the diagnosis of platypnea-orthodeoxia syndrome.
Decompression sickness (DCS) with scuba diving may be more prevalent in divers with PFOs and that closure may reduce this risk. The pathophysiology of DCS causing neurologic symptoms is the formation of nitrogen gas bub­bles in the systemic venous circulatory system during rapid ascent some of which can bypass the lung ltering mechanism when a PFO is present, and subsequent arterial manifestations can include neurologic symptoms, cutaneous changes (Cutis marmorata) and joint “bends”. The current recommendation is counseling on the increased risk of DCS with PFO and avoidance of high-risk diving. SCAI guidelines recommend against PFO closure for prevention of DCS given no clear evi­dence to suggest benet [12] though allow for closure if the patient and physician participate in a shared decision making process.
Perhaps the most controversial condition asso­ciated with PFO is migraine. Migraines are dis­abling and can be incredibly challenging to treat so this has led to many different procedural solu­tions, one of which is PFO closure. PFO stroke study sub-group analyses rst discovered a reduction of migraine days among PFO closure patients. There are many proposed mechanisms by which PFOs are thought to contribute to migraine including chemicals crossing the PFO instead of being blocked by the blood brain bar­rier, micro-emboli and cerebral hypoxia. However, three RCTs testing device closure for treating migraine headaches (MIST [19], PREMIUM [20] and PRIMA [21]) were unable
to achieve their primary outcomes. Despite this, there remains signicant hope that PFO closure might benet this difcult to treat entity. A new study, RELIEF [22], is currently recruiting patients to test whether the Gore CARDIOFORM PFO occluder in patients that have migraines responsive to P2Y12 therapy may derive benet from PFO closure.
ASD: True atrial septal defects can have a sig­nicant degree of left to right shunting and are associated with right sided volume overload; therefore, right sided chamber dilation, pulmo­nary hypertension and atrial arrhythmias can be seen. The indication for ASD closure include the presence of RVE, suggesting signicant left to right shunting, even in the asymptomatic child. Some patients with long-standing untreated ASDs will develop pulmonary vascular disease, that when severe can reverse shunting leading to cyanosis. Decision-making regarding closure is more complex and if pulmonary vascular resis­tance is greater than 8 Woods’ units or two-thirds systemic vascular resistance or mean PA pressure greater than two-thirds of systemic blood pres­sure, closure is not pursued in favor of treating underlying pulmonary hypertension rst [2325]. Iatrogenic ASD’s following different procedures involving transeptal catheterization may sponta­neously close but if it causes substantial shunt­ing, including systemic hypoxemia, closure is indicated.
There are some ndings during initial evalua­tion that are contraindications to PFO and ASD closure until there is resolution. Percutaneous closure should not be pursued in patients who have active thrombi in the ileo-femoral venous system, inferior vena cava or atria as there is risk of embolization. Additionally, active infection is a contraindication due to the risk of device endocarditis.
PFO: There are two commercially available devices in the United States specically for PFO closure. The Abbott Amplatzer PFO Occluder and Gore Cardioform PFO Occluder. PFOs with concomitant septum primum fenestrations can also be treated with the Abbott Amplatzer Cribiform Occluder. Very large PFOs may be amenable to closure with the Abbott Amplatzer
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Septal Occluder used for ASDs. Gore also has developed an ASD occluder which can treat large PFOs as well.
Device selection for PFO and ASD closure is determined by multiple factors including the size and characteristics of the septal defect, the devices that are approved by the regulatory sys­tem of the country, operator experience and pref­erences, and some patient-specic features related to potential complications such as device erosion, nickel allergy, and potential need for future transseptal access to the left atrium. Atrial septal defect sizing often involves balloon sizing, i.e. inating a sizing balloon across the defect until shunting ceases and the “waist” on the bal­loon is measured by ultrasound or X-ray. PFO sizing to select the size of device to be used can utilize balloon sizing but often a stiff wire across the defect holds the septum primum in an open position and allows echocardiographic measure­ment of the PFO size. Atrial septal aneurysms of the septum primum and lipomatous septum secundum are further modiers of PFO device selection. Long tunnels can often be closed by both devices unless the tissue is non-compliant, preventing tunnel collapse and deforming the devices. Under-sizing of the device needed for both ASD and PFO closure can lead to incom­plete closure and even device embolization.
Device sizing recommendations are included in the instructions for use for the Amplatzer device. PFOs that are “simple” with a non­prominent atrial septal aneurysm (<20mm excur­sion), tunnel length <10 mm, and normal thickness septum secundum (<10 mm) can be closed with a 25mm device. Those that do not meet those criteria, will likely require a larger device. All these measurements are easily found on a thorough TEE.
Device selection for PFO closure is based on experience and availability. There are no random­ized data comparing the two PFO closure devices available in the US and they performed well in their respective clinical trials. Some ner points of device selection have been identied. In the presence of a small aortic rim, the Cardioform device may be safer given it is more exible and without rigid edges. Device erosion, often associ-
ated with decient rims, by the Amplatzer PFO Occluder is very rare, more so than with the Amplatzer ASD Occluder. To date, there have been no case reports of erosion with the Cardioform PFO device though there are reports of wire fracture causing tamponade [26]. However, the Cardioform may come with a slightly greater increased risk of atrial brillation in the early post-procedure period after PFO clo­sure [15]. Given the lack of a randomized com­parison involving patients with a diversity of PFO anatomy, it is not possible to say whether the two devices differ in terms of the complete­ness of PFO closure.
The last consideration may be a nickel allergy. Our practice is to counsel the patient regarding the unsettled nature of whether a cutaneous nick allergy is even relevant to the risk of an allergic reaction to an intravascular device. The suspicion of nickel allergy is often uncovered with a through history. Skin patch testing for nickel allergy is standard but does not accurately predict if a systemic reaction may occur from an implanted device containing nitinol, an alloy of nickel and titanium. Therefore, a nickel allergy is not an absolute contraindication to percutaneous device closure but given case reports of systemic reactions after PFO or ASD closure, careful counseling is recommended prior to proceeding with percutaneous PFO closure in patients with signicant nickel allergies. Surgical closure can be entertained in this patient population if there is enough concern and the patient desires PFO clo­sure without nickel containing materials [27]. New techniques of PFO closure using a trans­catheter suture deployment system may be con­sidered, although complete data are not yet available on other outcomes versus device­mediated closure techniques.
The role of PFO closure in patients with hypercoagulable states is less clear. The newest SCAI guidelines do suggest PFO closure in patients with a PFO related stroke, even with thrombophilia requiring anticoagulation [12]. However, the determination of whether a stroke is PFO related versus not in patients with a sig­nicant thrombophilia, such as anti-phospholipid antibody may be quite challenging. Given this, it
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would be reasonable to involve vascular neurol­ogy as well as hematology experts to provide individualized recommendations to patients. PFO closure may be reasonable as an “additive” therapy given there may be instances during which patients who would otherwise be on long­term anticoagulation cannot be on it, but this would need to be weighed against the risk of device related thrombosis.
Heart Team Decision: Percutaneous PFO Closure
In patients who do not have other indications for cardiac surgery, percutaneous closure of patent foramen ovale is recommended as it was in this patient’s case. Surgical closure of a PFO requires surgical access to the heart (sternotomy), cardio­pulmonary bypass, and a prolonged recovery ver­sus device-closure often being performed with conscious sedation on an outpatient basis with minimal recovery.
Intraprocedural Imaging Modalities andMeasurements, (Discussion Between Members oftheHeart Team)
Intraprocedural imaging for closure is usually done with intra-cardiac echocardiography or transesophageal echocardiography. Less fre­quently, the procedure is performed with TTE and angiographic guidance. Though limited in use, uoroscopy only guided closure of PFOs has been shown in small studies to be safe and effec­tive [28, 29].
Trans-esophageal echo cardiography offers the ability to both perform the screening TEE and therapeutic procedure in a single setting but typi­cally this requires deep sedation or general anes­thesia. Intracardiac echocardiography (ICE) allows the performance of the closure procedure to be done with conscious sedation, which may allow for same-day discharge due to faster recov­ery. Studies have shown the two methods to be equivalent [3032].
Typically, if the procedure is performed with ICE guidance, the interventionalist manipulates the catheter and has catheterization laboratory staff operate the imaging console with capture of key images. However, with the advent of 3D ICE, the presence of an echocardiographer experi­enced in acquiring 3D datasets and interpretation can be quite helpful. Regardless of modality, the procedural imaging follows the same general cadence. The use of uoroscopy is also useful to the interventionalist who can see the position of the device relative to cardiac borders and ensure the discs are deployed fully.
First, a repeat assessment of key cardiac struc­tures is performed to ensure no other possible sources of emboli (in the case of stroke patients) are found. TEE offers the advantage of once again assessing for the presence of LA and LV thrombi, which may not be as easily visualized with ICE. On TEE, the inter-atrial septum is imaged in a bicaval and short axis view. On ICE, a septal view is obtained by retroexion and clockwise rotation from the “home” view with the catheter in the right atrium (Video 5) The catheter is then advanced slightly cranial, which shows the SVC rim. Then, a short axis view which is like the TEE short axis view (other than in ICE the right atrium is at the apex of the imag­ing cone whereas in TEE the left atrium is at the apex of the imaging cone) is obtained by rotating clockwise and then retroexing further with slight leftward deection or using newer cathe­ters, with bi-plane of the septal view. This shows the aortic rim in detail [33].
The PFO is then assessed at rest, paying atten­tion to key features: the aortic rim, the presence and excursion of an atrial septal aneurysm, tunnel length, thickness of the septum secundum and degree of shunting by bubble. Not infrequently, if lower extremity injection was not performed as part of the screening TTE or TEE, with a bubble injection into the femoral vein, the degree of shunting becomes far more impressive.
After this, the defect is crossed, often without much effort with a standard J-tipped guidewire and multi-purpose diagnostic catheter. Imaging guidance can assist if there is difculty in ensur­ing the guidewire is positioned in the tunnel to
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cross the PFO (Video 6). If despite visualization of the J-wire in the tunnel, the wire is unable to cross, this may lead one to consider that the PFO may be too small to be the cause of a cryptogenic stroke or certainly, hypoxemia. One can try with hydrophilic guidewires or different shaped cath­eters if there is a strong indication for closure.
After crossing, echo guidance can help posi­tion the wire and catheter in the left upper pulmo­nary vein, which provides the best trajectory for insertion of the delivery sheath. Once positioned in the vein, the wire is exchanged for a stiff guidewire. Echo is used to ensure the wire is indeed in the pulmonary vein as uoroscopically, the left atrial appendage is in a similar position. Should the wire be in the LAA, this can be a cause of perforation given the thin-walled nature of the LAA.At this point, the PFO is maximally “propped” open (Video 7). Measurements of the PFO width are performed by measuring the width of the color jet on the right atrial side (Fig. 8). The tunnel length often also becomes more apparent as one can measure the length of the septum primum from the right atrial entrance to the tip of the primum on the left atrial side. A general rule is the right atrial disc width should be at least two times the width of the PFO or tun­nel length. This is because the PFO devices are not self-centering since the central portion is con-
necting pin rather than a true disc and therefore, when sizing, one must assume that the device may be pushed entirely into one corner of the defect and therefore, the radius of the device must be large enough to close the defect.
Once a device is chosen, echo guidance is used to ensure the delivery sheath tip is free in the left atrium (Video 8). Then, the left atrial disc is unsheathed and then pulled back such that it is pulled against the inter-atrial septum without prolapsing into the tunnel (Videos 9 and 10). Echo guidance is key for this step as if the LA disc falls into the tunnel, the device can be easily recaptured and torqued to allow the LA disc to sit against the septum. Then, while maintaining some tension, the right atrial disc is deployed and pushed against the septum. Again, echo guidance allows for visualization to ensure the entirety of the right atrial disc is on the right atrial side (Videos 11 and 12). At this point, the device is evaluated to ensure that there is no interaction with the aorta or SVC (Video 13), which if seen, is a marker for erosion. Fluoroscopically, in the LAO cranial view, the discs of the device should be separate and there may even be motion of the discs, reecting the motion of the tissue in between the two discs. A push-pull test is per­formed to demonstrate stability. If a disc is seen within the tunnel, then the device should be
Fig. 8 ICE image with color Doppler, wire over interatrial septum with measurements of the PFO width performed by measuring the width of the color jet on the right atrial side
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upsized. If the device is felt to be well positioned and sized, the device is released. Often, with release, there is dramatic shifting in the device as it orients to the natural lie of the inter-atrial sep­tum. The device is re-inspected to ensure both discs remain well positioned. A repeat bubble study can be performed to verify closure. Repeat color doppler should also be performed of the inter-atrial septum to document that there were no “missed” small atrial septal defects.
ASD: In contrast, atrial septal defect closure guidance at our center remains largely guided by TEE except in the cases of well dened, small ASDs with large rims on pre-procedure imaging; most often iatrogenic ASDs. Rims are best assessed with 2D views. For each ASD, we rec­ommend measuring rims in the following views: SVC and IVC rims in the mid-esophageal 90° view (Fig.9), aortic and posterior rims in the 45° mid-esophageal view (Fig.10), mitral and atrial rims in the 0° mid-esophageal view (Fig. 11). Most commonly, as in the case demonstrated here, aortic rims are decient and this is not a contraindication to percutaneous closure. Often, particularly with external referrals, these mea­surements are done on the table at the time of the closure procedure.
During the procedure, the defect size is con­rmed using 3D TEE.Then after crossing, bal-
loon sizing is performed (Fig. 12). The 34 mm balloon can be used for all ASDs since it is longer and will shift less with ination so many tend to only use this size but care must be taken to not over-inate the balloon and rupture the inter­atrial septum.
After sizing, the delivery catheter is advanced into the LA and TEE can be used to ensure the catheter is in the left upper pulmonary vein (Fig. 13). The LA disc is deployed and pulled against the septum (Fig.14), then the RA disc is deployed (Fig. 15). Before release, views are obtained to ensure no signicant leaks (Fig.16) and that there has been no impact on the sur­rounding structures: SVC and IVC ow, mitral valve function and the aortic root. A gentle tug test is performed to ensure stability and if so, the device is released and further evaluation for leaks is performed (Fig. 17) as with shifting of the device, new leaks may be identied as tension from the delivery cable is released.
Both available devices in the United States have been reported to close defects up to 40-44mm in diameter though strictly labeled, the Amplatzer can treat defects up to 38mm and the Gore up to 35mm by stop ow balloon sizing. Typically, with the Amplatzer device, a 5mm rim of tissue is needed for device stability and to decrease the risk of erosion. The major risk fac-
Fig. 9 ICE image of measurements of SVC and IVC rims of ASD in the mid-esophageal 90° view