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In the following part we describe the protocol steps of clinical and imaging evaluation of atrial communications before transcatheter closure based on international clinical guidelines. These protocols follow the guidelines of the Semmelweis University Regional and Institutional Committee of Science and Research Ethics. Informed written patient consent is needed.
1. Clinical evaluation and workflow of cryptogen stroke and PFO for transcatheter closure
- For the diagnostic work-up of stroke, determine whether the stroke is ischemic or hemorrhagic in origin using computed tomography scan (CT) or magnetic resonance brain imaging (MRI).
- In case of ischemic etiology, perform subsequent CT- or MR-angiography of the head and neck to exclude any intracranial- and cerebral- or extracerebral vascular pathology, which would warrant specific therapy.
- Perform blood work to test for a hypercoagulable state, most importantly an antiphospholipid syndrome or other genetic alterations leading to a coagulation disorder. A patient with hypercoagulability is not a good candidate for closure, as thrombus formation could occur on the surface or near the implanted device in these cases4,5.
- Use inpatient ECG monitoring to rule out atrial fibrillation.
NOTE: Further extended outpatient rhythm monitoring with an ambulatory 24-36-hour Holter, with an external event recorder or even with an insertable monitoring device, should be considered to detect the occurrence of atrial fibrillation, which is silent in a considerable proportion of stroke patients.
- Perform a TTE scan to exclude cardioembolic sources other than atrial fibrillation, such as non-compaction cardiomyopathy, dilated cardiomyopathy with severely depressed left ventricular ejection fraction, any intracardiac mass, vegetation or intracavitary thrombus and to assess the morphology of the interatrial septum for the presence of septal aneurysm.
NOTE: The latter can raise the suspicion for the presence of PFO.
- For the final work-up step in patient selection for PFO closure, make a multidisciplinary team decision involving the neurologist, the cardiologist and the cerebral imaging specialist.
2. Clinical evaluation and workflow of ASD for transcatheter closure
- Perform preprocedural cardiac MR (CMR) and right heart catheterisation (RHC) to diagnose complex congenital heart disease, where an ASD is only one element of a complex case. In these cases, closure of the ASD is usually part of a complex surgical repair procedure, rather than a transcatheter one.
NOTE: Simple, secundum type ASDs with a volume-overloaded RV due to a pulmonary/systemic flow (Qp/Qs) ratio of >1.5 and not elevated RV pressure are suitable for a single-step transcatheter closure if surrounded by a minimum rim of 5 mm6. Multi-fenestrated defects are often amenable for closure with multiple devices.
- Measure pulmonary vascular resistance (PVR) at baseline by RHC when shunting is excessive and there is elevated RV systolic pressure.
- In case of moderately elevated PVR (4-8 Wood units), perform a staged transcatheter closure by implanting a fenestrated closure device first to reduce the amount of initial shunting. Perform full closure after improvement of RV function and a decrease in PVR a couple of months later in a second step. Markedly elevated baseline PVR values above 8 Wood units usually form a contraindication for closure, as this would deteriorate RV function even further.
3. 2D transthoracic echocardiography imaging for the interatrial septum
NOTE: The assessment of interatrial septum is recommended according to the 2015 ASE guidelines2. The patient is lying in the left decubitus position with the left arm placed under the head. Standard parasternal, apical and subcostal views are obtained.
- Use the subxiphoid frontal four-chamber view; it provides good axial resolution to measure the diameter of the defect along its long axis.
- Use the subxiphoid sagittal view to visualize the atrial septum along its superior–inferior axis.
- Use the apical four-chamber view to estimate haemodinamic consequencies of interatrial left to right shunting including RA, RV dilation and RV pressure.
- Use the parasternal short-axis view to measure the aortic and posterior rim of the septal defect.
4. 2D/3D Transthoracic Echocardiography Imaging for the anatomical and functional quantification of heart chambers
NOTE: Assessment of atria is recommended according to the consensus statement from the ASE and EACVI on chamber quantification7.
- Perform conventional volumetric and functional LA measurement.
- Perform advanced echocardiography techniques using speckle tracking. Optimize acquisition frame rates for speckle tracking to provide the highest frame rate per cardiac cycle without significantly decreasing spatial resolution.
- In the 2D LA strain curve, set the zero strain reference at the left ventricular end-diastole. Calculate the LA strain values of each phase as the difference of two of these measurements8. LA function is divided into reservoir, conduit and contraction phase. All considerations made for LA measurements can be applied for RA assessment as well.
- Measure the tricuspid annular plane systolic excursion, the RV fractional area change, the Doppler tissue imaging (DTI) S’ velocity, and the RV ejection fraction from 3D volumetric evaluation. Perform 2D speckle tracking analysis with RV strain parameters for the evaluation of RV systolic function9.
NOTE: RV measurements are highly important in case of hemodynamically significant ASD, when RV function can be impaired and significant pulmonary hypertension can occur.
- Obtain electrocardiographically gated full-volume 3D data sets from apical four chamber view for 3D LA, LV and RV volume and function measurement, representing parameters of incremental prognostic value over 2D LA parameters10,11.
- Perform conventional volumetric and functional LV measurements, including LV diastolic function assessment using mitral inflow and annular tissue Doppler imaging.
NOTE: In case of diastolic dysfunction, acute heart failure may develope after ASD closure due to LV volume overload.
- Assess LV global longitudinal strain due to its prognostic value.
NOTE: However, circumferential and radial strain can be also assessed12,13.
5. Transesophageal echocardiography imaging for the interatrial septum
- Perform TEE examination in patients clinically suitable for potential percutaneous device closure to assess technical feasibility of the closure as well. Otherwise, perform TTE examination or transcranial doppler (TCD) using agitated saline to prove the presence of an interatrial shunt2,14,15,16. Informed written patient consent is mandatory before TEE examination.
- Position the patient on the left lateralis decubitus in case of preoperative screening TEE and on the back position in case of intraoperative TEE. Ensure that patients fast for at least 4 h and remove dental fixtures.
- Use topical oropharyngeal anesthesia (such as lidocaine) and intravenous sedatives (such as midazolam, typical dose 1-5mg) before screening TEE. The intraoperative guiding TEE is performed usually under general anaesthesia.
- Monitor ECG, blood pressure and oxygen saturation. Furthermore, availability and experience with resuscitation equipment is mandatory.
- Define the number, size and location of defects as well as the surrounding atrial septal tissue (rims) and the presence of atrial septal aneurysm. Determine the hemodynamic consequences of atrial septal defects using conventional 2D TEE views, of which midesophageal bicaval and aortic valve short axis view are the most important (Figure 2).
- Verify communication through the foramen using agitated saline contrast during the Valsalva maneuver, when the right atrial pressure temporarily increases, the overlapping septum primum and secundum opens, and the bubbles can cross the canal of PFO from the right atria to the left atria within 3 cardiac cycles.
NOTE: The amount of crossing bubbles depends on the size of PFO. A large (grade III) shunt is defined when the number of bubbles exceeds 20.
- Use 3D TEE acquisition methods mainly from the midesophageal short axis view or the bicaval view. Use the narrow-angled (zoomed) and wide-angled (full volume) mode to obtain additional information on the complex and dynamic anatomy of interatrial septum. Measure the size of atrial septal defect at the atrial end-diastole and end-systole in en face views from either the RA or LA (Figure 3).
- Use intraoperative transesophageal echocardiography to guide all steps of the procedure mainly from midesophageal bicaval and short axis view, including advancing the guidewire through the PFO tunnel or ASD and closure device delivery (Figure 1, Figure 4, Figure 5).
- Perform balloon sizing of the stretched diameter of ASD using fluoroscopy and TEE as well.
NOTE: The maximum size of the closure device is 90% of the atrial septal length; nevertheless, the ratio of the device to defect should not exceed 2:1 (Figure 6).
- Before the delivery system detachment, evaluate the presence of the residual shunt evaluation and measure the atrial septal tissue rim and atrial roof to closure device distance using a four chamber, short axis and bicaval TEE view.
6. Postoperative follow-up
- Perform the TTE study before hospital discharge and repeat within 1 month to assess device position, residual shunt and pericardial effusion due to device errosion.
- Perform TTE examination and 12-lead electrocardiography follow up studies at 6, and 12 months, with a subsequent evaluation every year.
- Measure conventional Doppler parameters to evaluate the effect of transcatheter ASD closure on left-sided chambers.
- Measure atrial and ventricular volumetric changes and longitudinal strain parameters are measured in order to track cardiac remodelling (Figure 7, Figure 8). Atrial arrhythmias occur mainly within 1 month after device deployment17.