The association of different right atrium anatomical-functional characteristics correlates with the risk of paradoxical stroke: an intracardiac echocardiographic study

Background: The contribution of different right atrium anatomical-functional characteristics to the risk of paradoxical stroke has not been extensively investigated, probably in part because of the limits of standard echocardiography.
Objective: We sought to assess, using intracardiac echocardiography (ICE), the right atrium anatomical-functional characteristics and their role in the pathophysiology of paradoxical embolism in a sample of patent foramen ovale (PFO) patients undergoing transcatheter PFO closure.
Methods: Over a 36-month period, we prospectively enrolled 114 consecutive patients (mean age 38+/− 10.5 years, 67 female) referred to our center for PFO catheter-based closure. On ICE study, all sensible characteristics other than PFO and mild ASA were recorded, including prominent EV or large CN, basal shunt without Valsalva maneuver, moderate to severe ASA, and multiperforated fossa ovalis.
Results: After TEE and ICE study and measurements, a prominent EV or CN was diagnosed on ICE in 73%, a basal shunt was present in 48%, a moderate to severe ASA in 47%, and a multiperforated FO in 24% of patients. A tight correlation between number of concurrent factors and proportion of patients with curtain pattern on TC Doppler, larger right-to-left shunt, recurrent cerebral paradoxical embolism before closure, and migraine with aura was clearly evident (r ≥= 0.97). Basal shunt and concurrent ≥= 3 anatomical functional right atrium characteristics resulted as independent predictors of recurrent paradoxical embolisms.
Conclusions: Our data suggest that right atrium anatomical-functional characteristics other than PFO and mild ASA as assessed by ICE deeply affect the pathophysiology of paradoxical stroke.     

Abnormalities of the Interatrial Septum as a Potential Cardiac Source of Embolism:

Stroke is a common and often devastating medical condition for the inflicted patient and his/her family. Certain abnormalities of the interatrial septum have recently been considered as potential causes for cerebral ischemic events. These abnormalities include atrial septal aneurysm (ASA) and patent foramen ovale (PFO). ASA is described as a bulging of the interatrial septum involving the region of the fossa ovalis. The prevalence of ASA is higher in patients undergoing transesophageal echocardiography (TEE) due to unexplained cerebral ischemia (15%) when compared to that of patients who had TEE performed for other reasons (4%). This apparently strong association between ASA and cerebral embolism has led to the consideration of ASA as a potential source of embolism. TEE appears to be more sensitive than transthoracic echocardiography (20% vs 6%) in detecting PFO. As with ASA, the prevalence of PFO is higher in those patients referred for unexplained cerebral ischemia than in those undergoing transesophageal studies for other reasons. Although a strong association between ASA, PFO, and stroke has been shown, the prognostic implications of these abnormalities are unclear. Therefore, longitudinal, prospective, and large scale studies are needed to evaluate the prognosis and clinical significance of these abnormalities.     

Intracardiac echocardiography-guided transcatheter closure of secundum atrial septal defect: a new efficient device selection method

OBJECTIVES: We assessed the use of intracardiac echocardiography (ICE) as the primary means for both selection of the Amplatzer Septal Occluder (ASO) and the guidance of transcatheter closure of secundum atrial septal defects (ASDs). BACKGROUND: The standard method for transcatheter closure of ASDs requires balloon-sizing maneuver and transesophageal echocardiographic (TEE) monitoring. The role of ICE during transcatheter closure of ASDs has not yet been established. METHODS: In 91 patients with ASDs, two standardized orthogonal sections were used to obtain ICE-derived measurements of the fossa ovalis and to assess optimal device deployment: the transverse section on the aortic valve plane, and the longitudinal section on the four-chamber plane. RESULTS: In all patients, ICE planes were identified with excellent resolution, providing proper measurements of the fossa ovalis, from which to derive geometric assumptions for the selection of an appropriately sized device. The ASO waist diameter was chosen on the basis of the r value (r = [square root c(2) + p(2)], where r is the radius of an ideal circle that intersects the elliptical fossa ovalis in its semi-latus rectum, c is the foci half-distance of the fossa ovalis, and p is its semi-latus rectum). During the procedure, the four-chamber plane allowed us to obtain easily interpretable images of all stages of device deployment. Midterm complete occlusion rate was 97.8%. No ICE-related complications occurred. CONCLUSIONS: The ICE evaluation of ASDs allows quantitative and qualitative information for both proper ASO selection and optimal device placement, thus eliminating the cumbersome balloon-sizing maneuver and the need for general anesthesia during TEE monitoring.     

Catheter closure of perforated secundum atrial septal defect under intracardiac echocardiographic guidance using a single amplatzer device: feasibility of a new method

OBJECTIVES: Little is known about the feasibility and effectiveness of perforated secundum atrial septal defects (ASDs) transcatheter closure. This study tested whether this type of fenestration can be percutaneously closed using a single Amplatzer PFO or Cribriform Occluder device in a patch-like fashion under intracardiac echocardiographic (ICE) guidance and monitoring. METHODS: Twenty-four adult patients with perforated ASDs underwent transcatheter single Amplatzer PFO or Cribriform Occluder device closure by using ICE as the primary imaging tool, both for crossing the flap valve and monitoring each stage of the procedure. The entire atrial septum and fossa ovalis end diastolic dimensions on 2 orthogonal ICE planes, as well as the distance between the eccentric guidewire passage and the more adjacent rim of the fossa ovalis on the longitudinal ICE plane, have been measured. RESULTS: On the basis of the ICE fossa ovalis size and its geometric evaluation, in order to completely cover the fossa ovalis with a single device, 2 Amplatzer PFO Occluders 25 mm, 9 Amplatzer PFO Occluders 35 mm, and 13 Amplatzer Cribriform Occluders (four 25 mm and nine 35 mm) have been implanted successfully. During follow-up (31.4, 7.2 months), complete closure by contrast echo color Doppler occurred in 16/24 (67%) patients after 24 hours, 19/24 (79%) after 1 mouth, 20/24 (83%) after 3 months, 22/24 (92%) after 1 year, and 23/24 (96%) after 2 years. CONCLUSIONS: Transcatheter closure of perforated ASDs using a single Amplatzer Occluder device under ICE guidance appears to be a suitable procedure, providing a low rate of residual shunting.     

Randomized study comparing mechanical with electronic 2-dimensional intracardiac ultrasound monitoring (MEDIUM) during percutaneous closure of patent foramen ovale in adult patients with cryptogenic stroke

BACKGROUND: Previous studies have shown that mechanical and electronic intracardiac echocardiography (ICE) improves ultrasound monitoring during transcatheter patent foramen ovale (PFO) interventional closure. OBJECTIVES: This study sought to compare the procedural data, clinical imaging quality, and effectiveness PFO closure by using two different ICE monitoring modalities. METHODS: Patients referred for PFO closure (n = 82) were randomly assigned to mechanical (group 1) or electronic (group 2) ICE monitoring of Amplatzer device implantation. The digital ICE images were evaluated offline by means of absolute visual grading analysis score (VGAS(abs)), and the residual shunting at follow-up were assessed by means of contrast echocardiographic studies, all blinded regarding the ICE closure monitoring modality. RESULTS: The two groups were comparable with respect to clinical baseline characteristics, intracardiac fossa ovalis measurements, and procedural data (fluoroscopy time, procedure time and measurement of the amount of radiation that the patients absorbed). The total VGAS(abs) ranked the mechanical clinical images in a higher order than the electronic ones (3.78 +/- 0.09 vs 3.58 +/- 0.12, P = 0.005); additionally, three patients (7.3%) of group 2 needed to cross over to mechanical ICE monitoring because a right-convex atrial septal aneurysm configured itself incompletely. No differences in rates of residual shunting were observed at 12 months follow-up between the two groups (97.5% vs 94.7%, P = 0.951). CONCLUSIONS: Electronic monitoring of PFO closure performed a less diagnostic impact than the mechanical one while maintaining comparable procedural data and clinical outcome. These results represent an important step in validating these new intracardiac ultrasound imaging modalities.     

Importance of Performing Transesophageal Echocardiography in Acute Stroke Patients older than Fifty

Background: The purpose of this study was to determine the value of transesophageal echocardiography (TEE) in determining the presence of cardiac manifestations that required anticoagulation in patients presenting with acute stroke. Methods: Of 626 consecutive stroke patients who underwent TEE, 188 patients with no obvious etiology for stroke were subcategorized according to age. TEE results were analyzed for cardiac findings suggestive of a cause for embolic stroke, including complex atheromas in the arch/ascending aorta, patent foramen ovale (PFO), atrial septal aneurysm (ASA), and intracavitary thrombi. Data were analyzed using Fisher's exact test. Results: Of 188 patients, 66% (125/188) were older than 50 years and 34% (63/188) were younger than 50 years. The incidence of complex atheroma was 12.8% (16/125) in patients older than 50 years as compared to 0% (0/63) in patients who were younger than 50 years (P = 0.002). In patients older than 50 years, findings that indicated a need for anticoagulation based on TEE results were found in 22.4% (28/125) (atheroma = 16, PFO = 12, ASA = 5, thrombus = 3, PFO + ASA = 1) compared to 14.3% (9/63) (atheroma = 0, PFO = 5, ASA = 2, thrombus = 2, PFO + ASA = 1) in patients younger than 50 years. Conclusions: TEE plays an important role in suspected embolic stroke patients of all age groups. Due to the higher incidence of complex atheromas in patients older than 50 years of age, TEE might be of added importance in identifying the candidates who may benefit from anticoagulation. (Echocardiography 2010;27:1086‐1092)     

Intracardiac versus transesophageal echocardiography for left atrial appendage occlusion with watchman

Background: Left atrial appendage occlusion (LAAO) is mostly performed by transesophageal echocardiography (TEE) guidance. Intracardiac echocardiography (ICE) may be an alternative imaging modality for LAAO that precludes the need for general anesthesia or sedation. Methods and Results: All consecutive single center, single operator LAAO candidates were analyzed. Baseline clinical and procedural characteristics and in‐hospital outcomes were compared between patients in whom a Watchman was implanted with ICE vs. TEE guidance. In 76 consecutive patients the Watchman device was deployed under ICE in 32 patients (42%) and under TEE guidance in 44 patients (58%). Baseline characteristics were comparable between groups, except that patients in the TEE group were older (81 [75–85] years vs. 75 [68–80] years, P = 0.007). Total injected contrast media as well as fluoroscopy time were comparable between groups (90 ml [54–140] vs. 85 ml [80–110], P = 0.86 and 7.9 min [6.4–15.5] vs. 9.8 min [7.0–13.2], P = 0.51, for TEE vs. ICE, respectively). However, time from femoral venous puncture to transseptal puncture and to closure was longer in the ICE group (14 min [7.3–20] vs. 6 min [3.3–11], P = 0.007 and 48 min [40–60] vs. 34.5 min [27–44], P = 0.003, respectively). In the TEE group one patient suffered esophageal erosion with bleeding, which was managed conservatively and one non‐LAAO related in‐hospital mortality occurred in an 88‐year‐old patient. Device implantation success rate was 100% in both groups. No device embolization, no significant peri‐device leak, no tamponade, no stroke, and no access site bleeding occurred in any patient. Total hospital stay for stand‐alone LAAO was comparable between groups (2 days [2–2] vs. 2 days [2–3.3], P = 0.17, in ICE vs. TEE, respectively). Conclusions: ICE guidance for LAAO with the Watchman device is feasible and comparable to TEE and may become the preferred imaging modality for LAAO. © 2016 Wiley Periodicals, Inc.     

Initial clinical experience with intracardiac echocardiography in guiding transcatheter closure of perimembranous ventricular septal defects: feasibility and comparison with transesophageal echocardiography.

Over the last several years, intracardiac echocardiography (ICE) has been employed successfully in guiding transcatheter device closure of a secundum atrial septal defect (ASD) or patent foramen ovale (PFO). Nothing is known regarding the use of ICE to guide catheter device closure of a perimembranous ventricular septal defect (PMVSD). Twelve patients (seven female/five male) who had a PMVSD (among them, three patients with associated atrial communications: two with an ASD and one with a PFO) underwent attempts at transcatheter device closure using the Amplatzer membranous VSD device of their defects, using sequential transesophageal echocardiography (TEE) and ICE guidance with general endotracheal anesthesia (five patients) and using ICE alone with conscious sedation (seven patients). The mean age of patients was 16.9 +/- 3.7, and their mean weight was 42.4 +/- 6.6. Their mean left ventricular end-diastolic dimension preclosure was 45.7 +/- 2.5. The Qp/Qs ratio ranged from 1.0 to 1.8:1. During the procedure, the ICE catheter was positioned in the right atrium (RA) in all 12 patients and the ICE catheter was advanced to the left atrium to obtain a view of the ventricular septum in 3. Both TEE and ICE provided similar anatomical views of the position of the PMVSD. Furthermore, the relationship of the defect to the aortic valve and tricuspid valves, the measured size of defect, and the guidance of various stages of device deployment were comparable by TEE and ICE. There were no complications encountered during or after closure. We conclude that ICE provides unique images of the PMVSD and measurements similar to those obtained by TEE. ICE potentially could replace TEE in most patients as a guiding imaging tool for PMVSD device closure, thus eliminating the need for general endotracheal anesthesia.     

Transcatheter closure of atrial septal defects and patent foramen ovale under intracardiac echocardiographic guidance: feasibility and comparison with transesophageal echocardiography.

Transesophageal echocardiography (TEE) has been employed successfully for guiding transcatheter device closure of secundum atrial septal defect (ASD) and patent foramen ovale (PFO). However, the use of TEE for device closure requires general anesthesia. Intracardiac echocardiography (ICE) can provide similar anatomical views that might replace the use of TEE for device closure. Eleven patients (eight female/three male) with secundum ASD and PFO associated with strokes underwent attempts at transcatheter closure of their defects under sequential TEE and ICE guidance (six patients) and under ICE alone (five patients). The ages of the patients ranged from 6.6 to 74.7 yr, and their weights ranged from 23 to 124.5 kg. The sizes of the defects, as measured by TEE (six patients), ranged from 3 to 27 mm and, as measured by ICE (11 patients), from 3 to 27 mm. The balloon-stretched diameter of the ASD, as measured by TEE (six patients), ranged from 16 to 38 mm and, as measured by ICE (11 patients), from 16 to 35 mm. Both techniques correlated well for the measured two-dimensional diameter and for the balloon-stretched diameter (r = 0.97 and 0.98, respectively). Both TEE and ICE provided similar views of the defects and the various stages of device deployment. Owing to the proximity of the left atrium to the esophagus, however, the images obtained by ICE were more helpful and informative than those obtained by TEE. All patients experienced successful device placement (six patients under both TEE and ICE; five patients under ICE guidance alone); complete closure of the defects was effected in nine patients, whereas two patients had small residual shunts. There were no complications. We conclude that ICE provides unique images of the atrial communications and measurements similar to those obtained by TEE. ICE potentially could replace TEE as a guiding imaging tool for ASD and PFO device closure, thus eliminating the need for general anesthesia.     

Intracardiac versus transesophageal echocardiography to guide transcatheter closure of interatrial communications: Nationwide trend and comparative analysis

Objectives

This study aimed to assess current temporal trends in utilization of ICE versus TEE guided closure of interatrial communications, and to compare periprocedural complications and resource utilization between the two imaging modalities.

Background

While transesophageal echocardiography (TEE) has historically been used to guide percutaneous structural heart interventions, intracardiac echocardiography (ICE) is being increasingly utilized to guide many of these procedures such as closure of interatrial communications.

Methods

Using the Nationwide Inpatient Sample, all patients aged >18 years, who underwent ASD or PFO closure with either ICE or TEE guidance between 2003 and 2014 were included. Comparative analysis of outcomes and resource utilization was performed using a propensity score‐matching model.

Results

ICE guidance for interatrial communication closure increased from 9.7% in 2003 to 50.6% in 2014. In the matched model, the primary endpoint of major adverse cardiovascular events occurred less frequently in the ICE group versus the TEE group (11.1% vs 14.3%, respectively, P = 0.008), mainly driven by less vascular complications in the ICE group (0.5% vs 1.3%, P = 0.045). Length of stay was shorter in the ICE group (3 ± 4 vs 4 ± 4 days, P < 0.0001). Cost was similar in the two groups 18 454 ± 17 035$ in the TEE group vs 18 278 ± 15 780$ in the ICE group (P = 0.75).

Conclusions

Intracardiac echocardiogram utilization to guide closure of interatrial communications has plateaued after a rapid rise throughout the 2000s. When utilized to guide interatrial communication closure procedure, ICE is as safe as TEE and does not increase cost or prolonged hospitalizations.

     

Figulla PFO occluder versus Amplatzer PFO occluder for percutaneous closure of patent foramen ovale

Background : Percutaneous closure of patent foramen ovale (PFO) has been shown safe and feasible using several devices. The Occlutech Figulla single layer PFO Occluder (FPO) constitutes an alternative to the Amplatzer PFO Occluder (APFO). Objectives : We report our experience with both devices in a single‐center case–control study. Methods : Twenty patients undergoing percutaneous PFO closure using an FPO for secondary prevention of paradoxical embolism or diving were blindly matched with 20 patients receiving an APFO during the same time period. Contrast transesophageal echocardiography (TEE) was performed 6 months after device implantation to assess for residual shunting and device‐associated thrombus. Results : Patient baseline characteristics were well matched by study design. Procedural success was 95% with FPO vs. 100% for APFO (P = 1.0), with 3 (15%) peri‐procedural complications with FPO vs. none with APFO (P = 0.24). These comprised one asymptomatic device embolization in the descending aorta with percutaneous retrieval, one transient ischemic attacks, and one suspected device endocarditis. Contrast TEE at 6 months showed significantly more residual shunts in the FPO‐group (39% vs. 0%; P = 0.01). Two FPO patients with a moderate residual shunt underwent implantation of a second device (APFO 25 mm) vs. none in the APFO group (P = 0.48). No thrombi were observed in either group. During 1.7 ± 0.7 years of follow‐up, no death or recurrent embolic event occurred. Conclusions : According to this single‐center case–control study, PFO closure with the FPO appears less efficacious than with the APFO. © 2010 Wiley‐Liss, Inc.     

Modified percutaneous suture‐mediated patent fossa ovalis closure for prevention of cerebral ischemic events

Percutaneous suture‐mediated transcatheter patent fossa ovalis (PFO) closure has been shown to be an effective and safe technique with self‐evident advantages due to the lack of a permanent device heart implant. The success of this novel technique relies on an optimal catch of the interatrial septa, especially the septum primum which is floppier than the bulkier muscular septum secundum. We hypothesized that double suture of septum primum would further improve the efficacy of the procedure by increasing the surface contact between the septa when the septum primum is bent into the right atrium. We have provided proof of this concept by implementing a modified technique in two patients with PFO and cerebral ischemic events.     

Transesophageal Contrast Echocardiography is Not Always the Gold Standard Method in the Identification of a Patent Foramen Ovale: A Clinical Case

In the embryo, Eustachian valve is a crescent-shaped membrane extending from the lower margin of the inferior vena cava and the ostium of the coronary sinus into the right atrium toward fossa ovalis and tricuspid valve. At birth, after the functional closure of the foramen ovale, the Eustachian valve loses its function, reducing to an embryo remnant.According to growing evidence, a persistent Eustachian valve is a frequent finding in patients with a patent foramen ovale (PFO). By directing the blood from the inferior cava to the interatrial septum, it may prevent the spontaneous closure of PFO after birth and indirectly predispose to paradoxical embolism.Transesophageal contrast enhanced echocardiography (cTEE) is considered the gold standard to diagnose a PFO in postnatal life, but its accuracy maybe is not so high in the presence of a persistent Eustachian valve.In these cases, color Doppler TEE is more sensitive and simplifies the diagnostic process, reducing the duration of TEE and improving the patient compliance.     

Premere occlusion system for transcatheter patent foramen ovale closure: Mid‐term results of a single‐center registry

Background: Transcatheter closure of patent foramen ovale (PFO) with rigid devices may be problematic in patients with long channel PFO: alternative devices with asymmetrical opening and more physiological positioning may be preferable in such cases. We present the mid‐term results of transcatheter closure of PFO with Premere Occlusion System, a device studied for this specific anatomy, in a single‐center registry of adults with previous cerebral ischemia. Methods: During a 53‐months period (July 1, 2005 to December 1, 2009) 70 patients (48 females and 22 males, mean age 38 ± 6.7 years) with previous stroke were admitted in our center for transcatheter closure of PFO with Premere Occlusion System on the basis of absence of moderate or severe atrial septal aneurysm (ASA) on Transesophageal echocardiography and intracardiac echocardiography (< 3RL or 3LR ASA and length of PFO channel >10 mm). Results: The procedure was successful in all of the patients with no peri‐operative and in‐hospital complications. Forty‐six 20 mm and twenty‐four 25 mm Premere devices were implanted. Rates of procedural success, predischarge occlusion, and complication were: 100%, 95.7% and 0%, respectively. On mean follow‐up of 40 ± 10.9 months (range 6–54), the follow‐up occlusion rate was 98.5%. During follow‐up, no cases of permanent atrial fibrillation, aortic/atrial erosion, device thrombosis, or atrioventricular valve inferences were noted. Conclusion: The mid‐term outcomes of our registry suggests that the Premere Occlusion System may be an excellent device for patients with long‐channel PFO and absence of moderate/severe ASA, offering a physiological and anatomically respective closure of PFO also in patients with hypertrophic rims. © 2010 Wiley‐Liss, Inc.     

Is routine ultrasound guidance really necessary for closure of patent foramen ovale using the Amplatzer PFO occluder?

Objectives:

The aim of the study was to evaluate safety, efficacy, and long‐term clinical outcome of percutaneous closure of patent foramen ovale (PFO closure) in a low volume center using the Amplatzer PFO occluder without echocardiographic guidance.

Background:

Most centers perform PFO closure either by transesophageal echocardiography (TEE) or intracardiac echocardiography (ICE) guidance for optimal device selection. As TEE is poorly tolerated by patients in supine position and ICE is a costly alternative that increases vascular access complications, we wanted to assess the safety and efficacy of PFO closure by fluoroscopic guidance only.

Methods:

Before PFO closure, all patients had a diagnostic contrast‐TEE and morphological classification of PFO. All PFO closures were performed using the 25‐mm Amplatzer PFO occluder with fluoroscopic guidance only. Intraprocedural echocardiography was replaced by right atrial opacification using contrast angiography. Contrast TEE was done after 6 weeks, contrast TTE after 3, 6, and 12 months postprocedural.

Results:

In all 92 patients (52.4 ± 1.5 years), a 25‐mm Amplatzer PFO occluder was implanted in the correct position. Total fluoroscopic time was 8.4 ± 0.6 minutes and the application of contrast medium was 122.5 ± 5.8 mL. By contrast‐TEE, 12 patients (13 %) showed a small residual shunt (grade 1). During follow‐up (2.09 ± 0.13 years) two patients (2.1%) suffered from a recurrent event (TIA in both cases).

Conclusions:

Percutaneous closure of PFO using the 25‐mm Amplatzer PFO occluder guided by fluoroscopy only is a safe and efficacious intervention for nearly all patients. © 2009 Wiley‐Liss, Inc.     

Device-less patent foramen ovale closure by radiofrequency thermal energy

The goal of this study was to assess the feasibility, safety and success of a system which uses radiofrequency energy (RFE) rather than a device for percutaneous closure of patent foramen ovale (PFO). METHODS: Sixteen patients (10 men, 6 women, mean age 50 years) were included in the study. All of them had a proven PFO with documented right-to-left shunt (RLS) after Valsalva manoeuvre (VM) during transoesophageal echocardiography (TEE). The patients had an average PFO diameter of 6 +/- 2 mm at TEE and an average of 23 +/- 4 microembolic signals (MES) in power M-mode transcranial Doppler sonography (pm-TCD), measured over the middle cerebral artery. An atrial septal aneurysm (ASA) was present in 7 patients (44%). Balloon measurement, performed in all patients, revealed a stretched PFO diameter of 8 +/- 3 mm. In 2 patients (stretched diameter 11 and 14 mm respectively, both with ASA >10 mm), radiofrequency was not applied (PFO too large) and the PFO was closed with an Amplatzer PFO occluder instead. A 6-month follow-up TEE was performed in all patients. RESULTS: There were no serious adverse events during the procedure or at follow-up (12 months average). TEE 6 months after the first RFE procedure showed complete closure of the PFO in 50% of the patients (7/14). Closure appeared to be influenced by PFO diameter, complete closure being achieved in 89% (7/8) with a balloon-stretched diameter < or =7 mm but in none of the patients >7 mm. Only one of the complete closure patients had an ASA. Of the remainder, 4 (29%) had an ASA. Although the PFO was not completely closed in this group, some reduction in the diameter of the PFO and in MES was documented by TEE and pm-TCD with VM. Five of the 7 residual shunt patients received an Amplatzer PFO occluder. Except for one patient with a minimal residual shunt, all showed complete closure of PFO at 6-month follow-up TEE and pm-TCD with VM. The other two refused a closure device. CONCLUSIONS: The results confirm that radiofrequency closure of the PFO is safe albeit less efficacious and more complex than device closure. The technique in its current state should not be attempted in patients with a balloon-stretched PFO diameter >7 mm and an ASA.     

Patent foramen ovale in a large population of ischemic stroke patients: diagnosis, age distribution, gender, and race

BACKGROUND: Patent foramen ovale (PFO) is a well-recognized risk factor for ischemic strokes. The true prevalence of PFO among stroke patients is still under debate. Transesophageal echocardiography (TEE) is the "gold standard" in diagnosing PFO but the physiology requires right-to-left atrial shunting. In this report, we evaluate the prevalence of PFO in a diverse group of ischemic stroke patients studied by TEE. METHODS: TEE of 1,663 ischemic stroke patients were reviewed for cardiac source of embolism, including PFO and atrial septal aneurysm (ASA). Agitated saline bubble injection was performed to look for right to left atrial shunting. Success of maneuvers to elevate right atrial pressure (RAP) was noted by looking at the atrial septal bulge. RESULTS: Among 1,435 ischemic stroke patients analyzed, the presence or absence of PFO could not be determined in 32.1% because bulging of the septum could not be demonstrated in patients with negative contrast study despite aggressive maneuvers to elevate RAP. Of the remaining 974 patients, 294 patients (30.2%) had a PFO. The mean age was 61.5 years in both groups, with a bimodal distribution of PFO and the highest prevalence occurring in < or =30-year-old group. Prevalence of PFO was similar in men (32.4%) and women (28.15%, P = 0.15); and in Caucasian (32.1%) and African American (27.7%; P = 0.15). ASA was present in 2.02% and hypermobile septum in 2.49% of the 1,435 patients. PFO was seen in 79.3% of the patients with ASA. CONCLUSION: Successful elevation of RAP cannot be achieved in a significant number of patients undergoing TEE and determination of PFO may be difficult. In our series, the true prevalence of PFO among ischemic stroke patients was 30.2% taking into account only those patients who showed no shunting despite bulging of the atrium septum into the left atrium (PFO absent group) during the contrast study. There was no gender or racial difference in the prevalence of PFO, but there was a bimodal distribution in prevalence with age.     

Use of Intracardiac Compared With Transesophageal Echocardiography for Left Atrial Appendage Occlusion in the Amulet Observational Study

ObjectivesThe aim of this study was to compare patient and procedural characteristics, clinical events, and left atrial appendage (LAA) occlusion rates among implantation procedures guided either by intracardiac echocardiography (ICE) or by transesophageal echocardiography (TEE) in the Amulet Observational Study.BackgroundTEE is standard for intraprocedural imaging during LAA occlusion. ICE is an alternative enabling local rather than general anesthesia.MethodsThe Amulet Observational Study is a prospective, multicenter, post-market study of the Amulet device in patients with atrial fibrillation at risk for thromboembolism from the LAA. Procedures were guided by ICE in the left atrium or TEE. A clinical events committee adjudicated serious adverse events. LAA closure was assessed by a core laboratory 1 to 3 months post-implantation.ResultsNine hundred fifty-five procedures were TEE guided and 130 (12%) were ICE guided. Local anesthesia was used in 93% of ICE-guided cases. Implantation success was >99% in both groups (p = 1.00). The procedure was longer (40 ± 31 min vs. 33 ± 21 min; p = 0.01) and contrast use higher (145 ± 157 ml vs. 98 ± 76 ml; p < 0.01) for ICE cases. LAA closure rate was 100% using ICE and 98% using TEE. Vascular access serious adverse events occurred in 0.8% of ICE patients and 1.5% of TEE patients (p = 0.52). Pericardial effusions or tamponade was observed at rates of 2.5% per year and 1.7% per year in ICE and TEE patients, respectively (p = 0.57). Rates of ischemic stroke (4.1% per year vs. 2.6% per year; p = 0.37) and major bleeding (8.2% per year vs. 10.6% per year; p = 0.44) did not differ significantly between ICE and TEE patients.ConclusionsAmulet LAA occlusion procedures guided by ICE and TEE resulted in comparable clinical event and LAA closure rates, without differences in procedural or vascular complications despite longer procedures and more contrast use.     

Transesophageal echocardiography through nasal way as a guide to percutaneous closure of patent foramen ovale

Percutaneous device closure of patent foramen ovale (PFO) has become an effective and safe alternative to medical or surgery treatment. Transesophageal echocardiography (TEE), as commonly used to guide this procedure, has the limitation to require general anesthesia. Recently, intracardiac echocardiography (ICE) with AcuNav probe was used to guide percutaneous PFO closure. We report a 42 year-old man with two previous cryptogenetic strokes in whom both diagnosis and guidance of PFO closure were performed by means of TEE using the AcuNav catheter introduced through nasal way (TEENW). This technique, that does not require general anesthesia, provided adequate and complete view of the Amplatzer procedure. TEENW might offer a feasible and equivalent echocardiographic alternative either to standard TEE or ICE as a guide to percutaneous PFO closure.     

Role of intracardiac echocardiographic guidance in transcatheter closure of atrial septal defects and patent foramen ovale using the Amplatzer device

Transesophageal echocardiography (TEE) has been successfully used for guiding transcatheter device closure of secundum atrial septal defect (ASD) and patent foramen ovale (PFO). However, the use of TEE for device closure requires general anesthesia. Experience with intracardiac echocardiographic (ICE) guidance to close ASD and PFO is limited. One hundred eleven patients (76 female/35 male) with secundum ASD (82 patients) and PFO (29 patients) associated with a stroke underwent an attempt of transcatheter closure of their defects under ICE guidance using the new AcuNav catheter. The median age of patients was 40 years (range 2.5-80.7) and the median weight was 66 kg (range 12.7-128 kg). The median two-dimensional size of secundum defects as measured by ICE was 17 mm (range 3-32 mm). The median balloon stretched diameter of the ASDs was 22 mm (range 4-36 mm). Five patients had more than one defect that required placement of two devices to close the defects. The median Qp/QS ratio for patients with secundum ASD was 2.1 (range 1-18). ICE provided adequate views of the defects and surrounding structures and the various stages of device deployment. All patients had successful device placement, including the patients who received simultaneous two devices with immediate complete closure of the defects in 100 patients, whereas four and seven patients had trivial and small residual shunt, respectively. The median fluoroscopy time was 10.2 minutes (range 3.7-38.4 minutes) and the median total procedure time was 60 minutes (range 28-180 minutes). There were no complications related to the use of the AcuNav catheter. We conclude that ICE provided unique images of the atrial communications and facilitated device closure of secundum ASD and PFO in children and adults. We believe ICE should replace TEE as a guiding imaging tool for ASD and PFO device closure, thus eliminating the need for general anesthesia.