Usefulness of Intracardiac Echocardiography with a Mechanical Probe for Catheter-Based Interventions: A 10-year Prospective Registry Gianluca Rigatelli, MD, PhD,1 Fabio Dell’Avvocata, MD,1 Massimo Giordan, MD,1 Nicola Viceconte, MD,2 Rocco Aldo Osanna, MD,2 Gabriele Braggion, MD,1 Silvio Aggio, MD,1 Paolo Cardaioli, MD,1 Jack P. Chen, MD3 1
Section of Adult Congenital and Adult Heart Disease, Cardiovascular Diagnosis and Endoluminal Interventions, Rovigo General Hospital, Rovigo, Italy 2 Interventional Cardiology Department, S. Carlo Hospital, Potenza, Italy 3 Saint Joseph’s Translational Research Institute, Atlanta, GA Received 5 December 2013; accepted 6 May 2014
ABSTRACT: Background. The clinical outcome benefit of intracardiac echocardiography (ICE) with a mechanical probe during congenital heart disease interventions has not been fully investigated. We reported the long-term results of a prospective registry of interatrial shunt closure guided by mechanical ICE. Methods. We enrolled 537 patients (mean age 48 6 19.0 years, 378 females) submitted to ICE-aided procedures in a prospective registry over a 10-year period (September 2003-September 2013). All patients underwent transesophageal echocardiography (TEE) before the planned procedure. We evaluated (1) structure identification capability, (2) fossa ovale and interatrial septum component measurement, (3) procedure monitoring capability, (4) procedural and fluoroscopy times, and radiograph dose, (5) probe-related complications. Results. ICE was successfully performed and was able to correctly identify the structures previously assessed by TEE in all patients. In 24 patients (4.5%), ICE allowed better anatomy definition than TEE. In 35 other patients (6.5%), ICE identified structures not observed by TEE, which led to change indications to interventions or the operative technique to be used. In 131 patients (24.4%), ICE evaluation led to change the planned device to be implanted. There was only one probe-related complication (0.2%). Conclusions. Mechanical ICE may offer a valid alternative to conventional TEE in guiding congenital C 2014 Wiley heart disease interventional procedures. V
Periodicals, Inc. J Clin Ultrasound 42:534–543, 2014; Published online in Wiley Online Library (wileyonlinelibrary.com). DOI: 10.1002/jcu.22177 Keywords: atrial septal defect; patent foramen ovale; echocardiography; anatomy
P
recisely assessing the anatomy of the right and left atrium and interatrial septum is becoming increasingly important in interventional cardiology of structural heart disease in the adult, as demonstrated by the increasing use of transesophageal echocardiography (TEE), intracardiac echocardiography (ICE), or MRI,1–3 in particular, in order to decrease the complication incidence of catheter-based closure, such as erosion and device embolization. ICE is emerging as an important imaging tool in the cath-lab, not only for interatrial shunt closure but also for left atrial appendage closure, mitral valve percutaneous repair, and transseptal puncture. Although electronic ICE probes are now available and accepted,4,5 the performance of the older and less expansive mechanical probes, which have been validated against MRI, has not been fully investigated.6 We evaluated the performance of ICE with a mechanical probe in a prospective 10-year multicenter registry. METHODS
Correspondence to: G. Rigatelli C V
2014 Wiley Periodicals, Inc.
534
We enrolled 537 patients (mean age 48 6 19.0 years, 378 females), submitted to ICE-aided JOURNAL OF CLINICAL ULTRASOUND
MECHANICAL INTRACARDIAC ECHOCARDIOGRAPHY TABLE 1 Demographic and Clinical Data Mean 6 SD or Number (%) Age (years) Male/female Secumdum atrial septal defect Cribrosus atrial septal defect Multiple ASD (>2 ASD) Mean right ventricle diameter (mm) Mean Qp/Qs Mean pulmonary artery pressure (mmHg) Residual shunt after surgery Patent foramen ovale Previous stroke Migraine with aura Migraine with no aura Positive cerebral magnetic resonance imaging Transcranial Doppler curtain pattern Transcranial Doppler shower pattern Platypnea orthodeoxya Contraindication to scheduled neurosurgery
48 6 19.1 138/399 (34.6%) 169/537 (31.4%) 65/169 (38.4%) 18/169 (10.6%) 49 6 21.8 2.4 6 0.8 39 6 11.3 1/169 (0.6%) 368/537 (68.5%) 356/368 (96.7%) 78/368 (21.1%) 51/368 (13.8%) 362/368 (98.3%) 267/368 (72.5%) 101/368 (28.5%) 3/368 (0.8%) 3/368 (0.8%)
procedures, in a prospective registry over a 10year period (September 2003-September 2013). All the patients underwent TEE before the planned procedure, which was patent foramen ovale (PFO) closure in 368 patients and secundum atrial septal defect (ASD) closure in 169 patients (Table 1). In line with our institutional protocol, all patients were screened with TEE prior to the intervention. Inclusion criteria for percutaneous ASD closure included: Qp/ Qs > 1.5, enlargement of right atrium (>16.84 mm2 area) and ventricle (inflow tract of right ventricle > 35 mm2),7 and ASD < 40 mm. Indications for percutaneous closure of PFO included a concurrent “shower” or “curtain” shunt pattern on transcranial Doppler (TCD)8 with or without Valsalva maneuver, positive (single or multiple ischemic foci) cerebral MRI or previous clinical stroke or transient ischemic attack, and medium or large PFO on TEE.9 All patients with secundum ASD and/or PFO were investigated by transthoracic echocardiography (TTE) and TCD, respectively, before TEE. The hospital ethical board approved the study. Written informed consent was obtained from all patients enrolled in the study. All the ICE studies were reviewed and analyzed by two independent observers with extensive experience in ICE (with an interobserver variability of 99.8%), evaluating (1) the structure identification capability, (2) the accuracy of interatrial septum and atrial component measurement, (3) the procedure monitoring capability, (4) the procedural and fluoroscopy times, and patients’ radiograph dose, (5) probe-related complications. VOL. 42, NO. 9, NOVEMBER/DECEMBER 2014
Discrepancies between TEE and ICE findings were resolved by MRI. Echocardiography Protocols Transesophageal Echocardiography. TEE was conducted using a Vivid 7 system (GE Healthcare, Milwaukee, WI). ASD was measured with Doppler at end-diastole, checking out the type of defect and possible anomalous pulmonary venous return. PFO diameter was assessed by measuring with electronic calipers the maximum opening of the foramen ovale at end diastole. After sonographic contrast medium was injected intravenously under local anesthesia, Valsalva maneuver was performed and right-to-left shunt was defined as permanent, small, medium, or large according to standard nomenclature,10 whereas atrial septal aneurysm (ASA) was defined according to recommendations from Olivares et al.11 Intracardiac Echocardiography Study and Monitoring. All patients underwent intracardiac echo-guided procedure by means of mechanical 9-F 9-MHz 360 scan probe (UltraICE; EP Technologies, Boston Scientific Corporation, San Jose, CA). Choice of this particular system was driven by economical issues and the need of a simple standardized protocol of study,12 which was not available for electronic probes at the start of the study in 2003. For ICE, the Ultra ICE catheter was inserted via a 55 precurved 8.5-F long venous sheath (Convoy; EP Technologies, Boston Scientific Corporation) from the left femoral vein and advanced through the inferior vena cava into the right atrium, in order to obtain the aforementioned two orthogonal planes, and subsequently withdrawing it through the body of the right atrium toward the inferior vena cava. The transducer was placed on the horizontal plane of the body and on the short axis of the right atrium. To appropriately display the images, it had to be rotated to comply with anatomic or cardiac MR standards. A few specific anatomic landmarks could be used for that purpose: the ascending aorta at 2 o’clock, the crista terminalis at 10 o’clock, and the right atrial auricle at 12 o’clock on the screen. With the probe in this neutral position and the transducer positioned between the sixth and the seventh thoracic intervertebral disks, the aortic valve plane view was obtained at the level of the fossa ovalis (Figure 1A). The four-chamber view was obtained with a 55 precurved introducer sheath advanced up to the end of the catheter 535
RIGATELLI ET AL
and turned posterior and leftward, with the transducer orientation perpendicular to the long axis of the heart in order to longitudinally scan the atrial septum (Figure 1B). The ICE study
FIGURE 1. Aortic valve plane (A) and four-chamber plane (B) as seen on intracardiac echocardiography. The left-sided structures are displayed on the viewer’s right; the right-sided structures are displayed on the viewer’s left. The anterior-sided structures are at the top of the screen and the posterior-sided structures are at the bottom of the screen. AO, ascending aorta; FO, fossa ovalis; LA, left atrium; MV, mitral valve; RA, right atrium; RUPV, right upper pulmonary vein; SVC, superior vena cava; TV, tricuspid valve.
was conducted in these two projections, measuring diameters of the fossa ovalis, the entire atrial septum length, rims, and thickness with electronic calipers edge-to-edge. Sizing of ASD and PFO was calculated under ICE as previously described using the concept of “supportive rim” for ASD13 without the aid of sizing balloon, and measuring the mean diameter of the fossa ovalis in two orthogonal projections for PFO. Five types of device were used for ASD/PFO closure, including stiff full nitinol device (Amplatzer ASD Occluder, Amplatzer ASD Cribriform Occluder, Amplatzer PFO Occluder; St. Jude Med. Corp.), semirigid mixed tissue/nitinol frame device (Gore Septal Occluder; Gore Inc., Flagstaff, Arizona, USA), soft mixed tissue/nitinol frame device (Premere Occlusion System, St. Jude Med. Corp.), and a soft bioadsorbable device (Biostar, NMT, Boston, USA). Each device was selected by the operator on the basis of the anatomic findings on ICE study: tunnelized PFO, secundum fenestrated ASD, or pure ASD associated or not with hypertrophy of the rim and different degree of ASA. Evaluation of Anatomic and Procedural Parameters. Measurements of diameter of the fossa ovalis or ASD were performed, and the presence and severity of ASA were assessed (according to Olivares et al11), as well as the presence of hypertrophic rims (defined as having a thickness 8 mm, whereas lipomatosis was defined as thickness of 15 mm14), the length of tunnel-type PFO (defined as length 10 mm), the presence of a prominent Eustachian valve (defined as a valve with thickness >1 mm that protruded for at least 10 mm within the right atrium from the border of the inferior vena cava), or a large Chiari network (defined as Eustachian valve with thickness
TABLE 2 Comparison Between Preoperative Transesophageal Echocardiography and Intraoperative Intracardiac Echography Identification of Anatomical Structures Anatomical Structures (%) ASD floppy rims (1 or >1) Embryonic remnant Deficient rims (1 or >1) Atrial septal aneurysm, 1–3 Atrial septal aneurysm, 4–5 Tunnel >10 mm Eustachian valve/Chiari network Other pathologic findings*
TEE
ICE
p
24/537 (5.2%) 3/537 (0.5%) 48/537 (8.9%) 201/537 (37.4%) 78/537 (14.5%) 88/537 (16.3%) 81/537 (15.0%) 1/537 (0.2%)
23/537 (4.2%) 21/537 (3.9%) 64/537 (11.9%) 169/537 (31.4%) 121/537 (22.5%) 129/537 (24.0%) 132/537 (24.5%) 11/537 (2.0%)
ns
Section of Adult Congenital and Adult Heart Disease, Cardiovascular Diagnosis and Endoluminal Interventions, Rovigo General Hospital, Rovigo, Italy 2 Interventional Cardiology Department, S. Carlo Hospital, Potenza, Italy 3 Saint Joseph’s Translational Research Institute, Atlanta, GA Received 5 December 2013; accepted 6 May 2014
ABSTRACT: Background. The clinical outcome benefit of intracardiac echocardiography (ICE) with a mechanical probe during congenital heart disease interventions has not been fully investigated. We reported the long-term results of a prospective registry of interatrial shunt closure guided by mechanical ICE. Methods. We enrolled 537 patients (mean age 48 6 19.0 years, 378 females) submitted to ICE-aided procedures in a prospective registry over a 10-year period (September 2003-September 2013). All patients underwent transesophageal echocardiography (TEE) before the planned procedure. We evaluated (1) structure identification capability, (2) fossa ovale and interatrial septum component measurement, (3) procedure monitoring capability, (4) procedural and fluoroscopy times, and radiograph dose, (5) probe-related complications. Results. ICE was successfully performed and was able to correctly identify the structures previously assessed by TEE in all patients. In 24 patients (4.5%), ICE allowed better anatomy definition than TEE. In 35 other patients (6.5%), ICE identified structures not observed by TEE, which led to change indications to interventions or the operative technique to be used. In 131 patients (24.4%), ICE evaluation led to change the planned device to be implanted. There was only one probe-related complication (0.2%). Conclusions. Mechanical ICE may offer a valid alternative to conventional TEE in guiding congenital C 2014 Wiley heart disease interventional procedures. V
Periodicals, Inc. J Clin Ultrasound 42:534–543, 2014; Published online in Wiley Online Library (wileyonlinelibrary.com). DOI: 10.1002/jcu.22177 Keywords: atrial septal defect; patent foramen ovale; echocardiography; anatomy
P
recisely assessing the anatomy of the right and left atrium and interatrial septum is becoming increasingly important in interventional cardiology of structural heart disease in the adult, as demonstrated by the increasing use of transesophageal echocardiography (TEE), intracardiac echocardiography (ICE), or MRI,1–3 in particular, in order to decrease the complication incidence of catheter-based closure, such as erosion and device embolization. ICE is emerging as an important imaging tool in the cath-lab, not only for interatrial shunt closure but also for left atrial appendage closure, mitral valve percutaneous repair, and transseptal puncture. Although electronic ICE probes are now available and accepted,4,5 the performance of the older and less expansive mechanical probes, which have been validated against MRI, has not been fully investigated.6 We evaluated the performance of ICE with a mechanical probe in a prospective 10-year multicenter registry. METHODS
Correspondence to: G. Rigatelli C V
2014 Wiley Periodicals, Inc.
534
We enrolled 537 patients (mean age 48 6 19.0 years, 378 females), submitted to ICE-aided JOURNAL OF CLINICAL ULTRASOUND
MECHANICAL INTRACARDIAC ECHOCARDIOGRAPHY TABLE 1 Demographic and Clinical Data Mean 6 SD or Number (%) Age (years) Male/female Secumdum atrial septal defect Cribrosus atrial septal defect Multiple ASD (>2 ASD) Mean right ventricle diameter (mm) Mean Qp/Qs Mean pulmonary artery pressure (mmHg) Residual shunt after surgery Patent foramen ovale Previous stroke Migraine with aura Migraine with no aura Positive cerebral magnetic resonance imaging Transcranial Doppler curtain pattern Transcranial Doppler shower pattern Platypnea orthodeoxya Contraindication to scheduled neurosurgery
48 6 19.1 138/399 (34.6%) 169/537 (31.4%) 65/169 (38.4%) 18/169 (10.6%) 49 6 21.8 2.4 6 0.8 39 6 11.3 1/169 (0.6%) 368/537 (68.5%) 356/368 (96.7%) 78/368 (21.1%) 51/368 (13.8%) 362/368 (98.3%) 267/368 (72.5%) 101/368 (28.5%) 3/368 (0.8%) 3/368 (0.8%)
procedures, in a prospective registry over a 10year period (September 2003-September 2013). All the patients underwent TEE before the planned procedure, which was patent foramen ovale (PFO) closure in 368 patients and secundum atrial septal defect (ASD) closure in 169 patients (Table 1). In line with our institutional protocol, all patients were screened with TEE prior to the intervention. Inclusion criteria for percutaneous ASD closure included: Qp/ Qs > 1.5, enlargement of right atrium (>16.84 mm2 area) and ventricle (inflow tract of right ventricle > 35 mm2),7 and ASD < 40 mm. Indications for percutaneous closure of PFO included a concurrent “shower” or “curtain” shunt pattern on transcranial Doppler (TCD)8 with or without Valsalva maneuver, positive (single or multiple ischemic foci) cerebral MRI or previous clinical stroke or transient ischemic attack, and medium or large PFO on TEE.9 All patients with secundum ASD and/or PFO were investigated by transthoracic echocardiography (TTE) and TCD, respectively, before TEE. The hospital ethical board approved the study. Written informed consent was obtained from all patients enrolled in the study. All the ICE studies were reviewed and analyzed by two independent observers with extensive experience in ICE (with an interobserver variability of 99.8%), evaluating (1) the structure identification capability, (2) the accuracy of interatrial septum and atrial component measurement, (3) the procedure monitoring capability, (4) the procedural and fluoroscopy times, and patients’ radiograph dose, (5) probe-related complications. VOL. 42, NO. 9, NOVEMBER/DECEMBER 2014
Discrepancies between TEE and ICE findings were resolved by MRI. Echocardiography Protocols Transesophageal Echocardiography. TEE was conducted using a Vivid 7 system (GE Healthcare, Milwaukee, WI). ASD was measured with Doppler at end-diastole, checking out the type of defect and possible anomalous pulmonary venous return. PFO diameter was assessed by measuring with electronic calipers the maximum opening of the foramen ovale at end diastole. After sonographic contrast medium was injected intravenously under local anesthesia, Valsalva maneuver was performed and right-to-left shunt was defined as permanent, small, medium, or large according to standard nomenclature,10 whereas atrial septal aneurysm (ASA) was defined according to recommendations from Olivares et al.11 Intracardiac Echocardiography Study and Monitoring. All patients underwent intracardiac echo-guided procedure by means of mechanical 9-F 9-MHz 360 scan probe (UltraICE; EP Technologies, Boston Scientific Corporation, San Jose, CA). Choice of this particular system was driven by economical issues and the need of a simple standardized protocol of study,12 which was not available for electronic probes at the start of the study in 2003. For ICE, the Ultra ICE catheter was inserted via a 55 precurved 8.5-F long venous sheath (Convoy; EP Technologies, Boston Scientific Corporation) from the left femoral vein and advanced through the inferior vena cava into the right atrium, in order to obtain the aforementioned two orthogonal planes, and subsequently withdrawing it through the body of the right atrium toward the inferior vena cava. The transducer was placed on the horizontal plane of the body and on the short axis of the right atrium. To appropriately display the images, it had to be rotated to comply with anatomic or cardiac MR standards. A few specific anatomic landmarks could be used for that purpose: the ascending aorta at 2 o’clock, the crista terminalis at 10 o’clock, and the right atrial auricle at 12 o’clock on the screen. With the probe in this neutral position and the transducer positioned between the sixth and the seventh thoracic intervertebral disks, the aortic valve plane view was obtained at the level of the fossa ovalis (Figure 1A). The four-chamber view was obtained with a 55 precurved introducer sheath advanced up to the end of the catheter 535
RIGATELLI ET AL
and turned posterior and leftward, with the transducer orientation perpendicular to the long axis of the heart in order to longitudinally scan the atrial septum (Figure 1B). The ICE study
FIGURE 1. Aortic valve plane (A) and four-chamber plane (B) as seen on intracardiac echocardiography. The left-sided structures are displayed on the viewer’s right; the right-sided structures are displayed on the viewer’s left. The anterior-sided structures are at the top of the screen and the posterior-sided structures are at the bottom of the screen. AO, ascending aorta; FO, fossa ovalis; LA, left atrium; MV, mitral valve; RA, right atrium; RUPV, right upper pulmonary vein; SVC, superior vena cava; TV, tricuspid valve.
was conducted in these two projections, measuring diameters of the fossa ovalis, the entire atrial septum length, rims, and thickness with electronic calipers edge-to-edge. Sizing of ASD and PFO was calculated under ICE as previously described using the concept of “supportive rim” for ASD13 without the aid of sizing balloon, and measuring the mean diameter of the fossa ovalis in two orthogonal projections for PFO. Five types of device were used for ASD/PFO closure, including stiff full nitinol device (Amplatzer ASD Occluder, Amplatzer ASD Cribriform Occluder, Amplatzer PFO Occluder; St. Jude Med. Corp.), semirigid mixed tissue/nitinol frame device (Gore Septal Occluder; Gore Inc., Flagstaff, Arizona, USA), soft mixed tissue/nitinol frame device (Premere Occlusion System, St. Jude Med. Corp.), and a soft bioadsorbable device (Biostar, NMT, Boston, USA). Each device was selected by the operator on the basis of the anatomic findings on ICE study: tunnelized PFO, secundum fenestrated ASD, or pure ASD associated or not with hypertrophy of the rim and different degree of ASA. Evaluation of Anatomic and Procedural Parameters. Measurements of diameter of the fossa ovalis or ASD were performed, and the presence and severity of ASA were assessed (according to Olivares et al11), as well as the presence of hypertrophic rims (defined as having a thickness 8 mm, whereas lipomatosis was defined as thickness of 15 mm14), the length of tunnel-type PFO (defined as length 10 mm), the presence of a prominent Eustachian valve (defined as a valve with thickness >1 mm that protruded for at least 10 mm within the right atrium from the border of the inferior vena cava), or a large Chiari network (defined as Eustachian valve with thickness
TABLE 2 Comparison Between Preoperative Transesophageal Echocardiography and Intraoperative Intracardiac Echography Identification of Anatomical Structures Anatomical Structures (%) ASD floppy rims (1 or >1) Embryonic remnant Deficient rims (1 or >1) Atrial septal aneurysm, 1–3 Atrial septal aneurysm, 4–5 Tunnel >10 mm Eustachian valve/Chiari network Other pathologic findings*
TEE
ICE
p
24/537 (5.2%) 3/537 (0.5%) 48/537 (8.9%) 201/537 (37.4%) 78/537 (14.5%) 88/537 (16.3%) 81/537 (15.0%) 1/537 (0.2%)
23/537 (4.2%) 21/537 (3.9%) 64/537 (11.9%) 169/537 (31.4%) 121/537 (22.5%) 129/537 (24.0%) 132/537 (24.5%) 11/537 (2.0%)
ns
