Abstract
Objective
We sought to prospectively evaluate long-term follow-up results of intracardiac echocardiography-aided transcatheter closure of interatrial shunts in adults.
Background
Intracardiac echocardiography improves the safety and effectiveness of transcatheter device-based closure of interatrial shunts, but its impact on long-term follow-up is unknown.
Methods
Over a 5-year period, we prospectively enrolled 258 consecutive patients (mean age 48±19.1 years, 169 females) who had been referred to our centre for catheter-based closure of interatrial shunts. All patients were screened with transesophageal echocardiography before the operation. Eligible patients underwent intracardiac echocardiography study and attempted closure.
Results
After intracardiac echocardiography study and measurements, 18 patients did not proceed to transcatheter closure due to unsuitable rims, atrial myxoma not diagnosed by preoperative transesophageal echocardiography or inaccurate transesophageal echocardiography measurement of defects more than 40 mm. The remaining 240 patients underwent transcatheter closure: transesophageal echocardiography-planned device type and size were modified in 108 patients (45%). Rates of procedural success, predischarge occlusion and complication were 100%, 94.2% and 5%, respectively. On mean follow-up of 65±15.3 months, the follow-up occlusion rate was 96.5%. There were no cases of aortic/atrial erosion, device thrombosis or atrioventricular valve inferences.
Conclusions
Intracardiac echocardiography-guided interatrial shunt transcatheter closure is safe and effective and appears to have excellent long-term results, potentially minimizing the complications resulting from incorrect device selection and sizing.
1
Introduction
Due to favorable results achieved by percutaneous closure as compared to medical therapy and surgical closure , transcatheter closure has emerged as the first-line therapy for the management of secundum atrial septal defects. Although indications and effectiveness as regards stroke prevention of patent foramen ovale closure remain questionable, percutaneous patent foramen ovale closure has replaced surgical closure as alternative to medical therapy in recent literature . It has been suggested that intracardiac echocardiography (ICE) improves safety and effectiveness of transcatheter device-based closure of interatrial shunts , but the impact of this technique on long-term follow-up has not yet been evaluated. We sought to prospectively evaluate 5-year follow-up results of ICE-aided transcatheter closure of interatrial shunts in adults.
2
Methods
We prospectively enrolled 258 consecutive patients (mean age 48±19.1 years, 169 females) who had been referred to our centre for catheter-based closure of interatrial shunts over a 5-year period. In line with our institutional protocol, all patients were screened with transesophageal echocardiography (TEE) prior to the intervention. Inclusion criteria for percutaneous closure of atrial septal defects included Qp/Qs more than 1.5, enlargement of right atrium (more than 16.84 mm of area) and ventricle (inflow tract of right ventricle more than 35 mm) and atrial septal defect less than 40 mm. Indications for percutaneous closure of patent foramen ovale defects included the following: a concurrent shower or curtain shunt pattern on transcranial Doppler with or without Valsalva maneuver, positive (single or multiple ischemic foci) cerebral magnetic resonance imaging or previous clinical stroke or transient ischemic attack, and medium or large patent foramen ovale on TEE . All patients with secundum atrial septal defect and/or patent foramen ovale were investigated by transthoracic echocardiography and transcranial Doppler, respectively, before TEE. The Hospital Ethical Board approved the study. Written informed consent was obtained from all patients enrolled in the study.
2.1
Echocardiography protocols
Transesophageal echocardiography was conducted using a GE Vivid 7 (General Electric Corp., Norfolk, VA, USA) with bubble test and Valsalva maneuver under local anesthesia. Patients who met the criteria for secundum atrial septal defect/patent foramen ovale closure were offered an ICE study using the mechanical 9F 9MHz UltraICE catheter (EP Technologies, Boston Scientific Corporation, San Jose, CA, USA). The ICE study was conducted as previously described by performing a manual pullback from the superior vena cava to the inferior vena cava through five sectional planes. Measurements of the diameters of the fossa ovalis, the secundum atrial septal defect, the entire atrial septum length and rims were obtained with electronic caliper edge-to-edge on the aortic valve plane and the four-chamber plane. Patent foramen ovale tunnel length was also measured. Intracardiac echocardiography monitoring of the implantation procedure was conducted on the four-chamber plane. A stretch diameter equivalent was calculated on the basis of rims with at least 1.2 mm of thickness, and secundum atrial septal defect and fossa ovalis diameters were calculated excluding the portion of rims less than 1.2 mm thick. Atrial septal aneurysms were classified according to Olivares et al. ( Fig. 1 ).
2.2
Radiological equipment
We used the GE Medical System Innova 2100 20–20 cm Flat Panel radiological equipment in all cases. Field size used was 20–20 cm. An estimation of the effective dose was obtained from the measurements of the total dose–area product that is automatically recorded by the radiological equipment during the procedures. Fluoroscopy and procedural times were also calculated.
2.3
Closure protocol
Combined antibiotic therapy (gentamicin 80 mg plus ampicillin 1 g, or vancomycin 1 g if there was a documented allergy to penicillin) was administered intravenously 1 h before the procedure. The right femoral vein was catheterized through an 8-French sheath that was used for preoperative right cardiac catheterization, and replaced with a 10- or 12-French long sheath for device implantation, whereas the left femoral vein was catheterized through an 8-French sheath that was replaced with a precurved 9-French long sheath for the ICE study ( Fig. 2 ).
2.4
Intraoperative closure criteria and device selection
On the basis of ICE findings and measurements, the operators selected the Amplatzer Occluder family (PFO Occluder, Cribriform Occluder, ASD Occluder, AGA Medical Corporation, Golden Valley, MN, USA) or the Premere PFO Closure System (St. Jude Medical Inc. GLMT). The Amplatzer PFO occluder was selected when atrial septal aneurysm was moderate with bidirectional excursion (3RL or 3LR atrial septal aneurysm following Olivares et al. ), whereas the Premere occlusion system was chosen when the atrial septal aneurysm was absent or in the case of motionless or unidirectional mild atrial septal aneurysm (1R, 2L atrial septal aneurysm following Olivares et al. ), when patent foramen ovale tunnel length was 10 mm or greater and in all cases of hypertrophy of the interatrial septum rims (more than 10 mm thick). The Amplatzer Cribriform Occluder was selected in the case of multiperforated atrial septal aneurysm, being careful to cross the most central hole in the oval fossa with the guide-wire during ICE guidance as previously described . In order to obtain a complete coverage of the oval fossa on both sides of the atrial septum, this occluder device was also selected when the atrial septal aneurysm was huge with bidirectional excursion (4–5RL atrial septal aneurysm following Olivares et al. ). Care was taken to choose a device with an entire left disk diameter that did not exceed the entire atrial septum length on ICE measurements.
The Amplatzer ASD Occluder was selected in the case of secundum atrial septal defect when anomalous venous return was angiographically excluded. Device sizing was obtained with the “equivalent circle area” method, described by Zanchetta et al. , which is the area of the circular waist equivalent to the elliptical atrial septal defect area obtained by the measurement of the diameter on the aortic valve plane (short axis of an ideally elliptical defect) and the four-chamber plane (long axis of an ideally elliptical defect), which are perfectly orthogonal views. Adding 2 mm to the diameter of this equivalent area, the diameter of the waist of the proper device to be implanted was obtained. This method has been proven to be equivalent to that obtained with balloon sizing and stop-flow technique .
2.5
Follow-up protocol
In patients who underwent closure, TEE was scheduled at 1 month and repeated at 6 months postclosure if there was more than a trivial shunt, to assess for potential erosions or thrombosis and residual shunts. Patients with patent foramen ovale-related syndromes also underwent transcranial Doppler ultrasound and magnetic resonance imaging of the brain prior to and 1 month after the procedure. Transthoracic echocardiography was scheduled at 6 and 12 months after the transcatheter closure to assess midterm residual shunt and the effect of the device on atrial and heart valve function.
Any residual shunt was graded as trivial, small, moderate or severe as previously described . Clinical examination was scheduled at 1, 6 and 12 months.
2.6
Definition
Success was defined as the ability to release the device in a stable position under fluoroscopy and ICE guidance with no more than a trivial shunt on immediate angiography and on transthoracic echocardiography at 24 h after closure. Immediate complications included any degree of groin haematoma, atrial wall perforation and pericardial effusion; entrapment of device or sheath or ICE equipment through venous valves or embryonic remnants; and air embolism. Predischarge occlusion rate was defined as a percentage of complete occlusion (presence of no more than a trivial shunt). Aortic erosion and device removal were included in the midterm complication rate.
2.7
Statistical analysis
χ 2 , corrected χ 2 and Student’s t tests were used to compare frequencies and continuous variables, with a significance level P <.05. Kaplan–Meier curve was employed to evaluate actuarial occlusion rates.
2
Methods
We prospectively enrolled 258 consecutive patients (mean age 48±19.1 years, 169 females) who had been referred to our centre for catheter-based closure of interatrial shunts over a 5-year period. In line with our institutional protocol, all patients were screened with transesophageal echocardiography (TEE) prior to the intervention. Inclusion criteria for percutaneous closure of atrial septal defects included Qp/Qs more than 1.5, enlargement of right atrium (more than 16.84 mm of area) and ventricle (inflow tract of right ventricle more than 35 mm) and atrial septal defect less than 40 mm. Indications for percutaneous closure of patent foramen ovale defects included the following: a concurrent shower or curtain shunt pattern on transcranial Doppler with or without Valsalva maneuver, positive (single or multiple ischemic foci) cerebral magnetic resonance imaging or previous clinical stroke or transient ischemic attack, and medium or large patent foramen ovale on TEE . All patients with secundum atrial septal defect and/or patent foramen ovale were investigated by transthoracic echocardiography and transcranial Doppler, respectively, before TEE. The Hospital Ethical Board approved the study. Written informed consent was obtained from all patients enrolled in the study.
2.1
Echocardiography protocols
Transesophageal echocardiography was conducted using a GE Vivid 7 (General Electric Corp., Norfolk, VA, USA) with bubble test and Valsalva maneuver under local anesthesia. Patients who met the criteria for secundum atrial septal defect/patent foramen ovale closure were offered an ICE study using the mechanical 9F 9MHz UltraICE catheter (EP Technologies, Boston Scientific Corporation, San Jose, CA, USA). The ICE study was conducted as previously described by performing a manual pullback from the superior vena cava to the inferior vena cava through five sectional planes. Measurements of the diameters of the fossa ovalis, the secundum atrial septal defect, the entire atrial septum length and rims were obtained with electronic caliper edge-to-edge on the aortic valve plane and the four-chamber plane. Patent foramen ovale tunnel length was also measured. Intracardiac echocardiography monitoring of the implantation procedure was conducted on the four-chamber plane. A stretch diameter equivalent was calculated on the basis of rims with at least 1.2 mm of thickness, and secundum atrial septal defect and fossa ovalis diameters were calculated excluding the portion of rims less than 1.2 mm thick. Atrial septal aneurysms were classified according to Olivares et al. ( Fig. 1 ).
2.2
Radiological equipment
We used the GE Medical System Innova 2100 20–20 cm Flat Panel radiological equipment in all cases. Field size used was 20–20 cm. An estimation of the effective dose was obtained from the measurements of the total dose–area product that is automatically recorded by the radiological equipment during the procedures. Fluoroscopy and procedural times were also calculated.
2.3
Closure protocol
Combined antibiotic therapy (gentamicin 80 mg plus ampicillin 1 g, or vancomycin 1 g if there was a documented allergy to penicillin) was administered intravenously 1 h before the procedure. The right femoral vein was catheterized through an 8-French sheath that was used for preoperative right cardiac catheterization, and replaced with a 10- or 12-French long sheath for device implantation, whereas the left femoral vein was catheterized through an 8-French sheath that was replaced with a precurved 9-French long sheath for the ICE study ( Fig. 2 ).
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