Percutaneous PFO Closure with Amplatzer PFO Occluder: Predictors of Residual Shunts at 6 Months Follow‐up

Objective. The objective of this study was to assess predictors of residual shunts after percutaneous patent foramen ovale (PFO) closure with Amplatzer PFO occluder (AGA Medical Corporation, Golden Valley, MN, USA). Methods. All percutaneous PFO closures, using Amplatzer PFO occluder performed at a tertiary center between May 2002 and August 2006, were reviewed. Follow‐up, including saline contrast transesophageal echocardiography, was performed in all patients 6 months after the intervention. Patients. A total of 135 procedures were performed. Mean age of the patients was 51 years. The indication for PFO closure was an ischemic cerebrovascular event in 92%, paradoxical systemic embolism in 4%, and a diving accident in 4%. Recurrent events prior to PFO closure were noted in 34%. A concomitant atrial septal aneurysm was present in 61%. Results. At 6 months follow‐up, a residual shunt was detected in 26 patients (19%). Residual shunts were more common in patients with an atrial septal aneurysm (27 vs. 8%, P= .01) and in patients treated with a 35‐mm compared with a 25‐mm device (39 vs. 15%, P= .01). A concomitant atrial septal aneurysm remained independently associated with residual shunts when controlled for body mass index, gender, age, atrial dimensions, and presence of a Chiari network (odds ratio 4.1, 95% confidence intervals 1.1–15.0). Conclusion. The presence of atrial septal aneurysms in patients undergoing percutaneous PFO closure with an Amplatzer PFO occluder significantly increases the rate of residual shunts at 6 months follow‐up, even if 35‐mm devices are used.     

Single centre experience with GORE-HELEX septal occluder for closure of PFO

Several devices are available for percutaneous patent foramen ovale (PFO) closure. Over the past 3 years our planned treatment strategy of PFO closure has been routine use of the GORE-HELEX septal occluder device, followed by 6 months of aspirin therapy. We present the safety and feasibility of routinely using this device for all patients undergoing percutaneous PFO closure, with 3-month transthoracic echocardiogram (TTE) follow up. In total, 75 adult patients (44.0+/-11.7 years; 45.3% male) were referred for PFO closure during the study period. All patients underwent echocardiography prior to PFO closure. In 5 patients no PFO was found, and 1 patient had an atrial secundum defect closed using the Amplatzer septal occluder. Of the 69 remaining patients with PFO, 68/69 (98.6%) underwent closure with the GORE-HELEX device. Six of 69 cases required device retrieval and 5 of 6 were replaced successfully with a second GORE-HELEX device. One of the 6, a large PFO associated with atrial septal aneurysm, was replaced using the Amplatzer septal occluder. There were no major complications. At 3-month follow up, 65/68 (95.6%) had no residual shunt on TTE, and 3 patients had small residual shunts thought to be related to incomplete endothelialisation at 3 months. In conclusion, percutaneous PFO closure using the GORE-HELEX septal occluder device is safe and feasible, with no major peri-procedural complications and excellent short-term results at 3-month follow up.     

Post-Market Clinical Follow-Up With the Patent Foramen Ovale Closure Device IrisFIT (Lifetech) in Patients With Stroke,Transient Ischemic Attack,or Other Thromboembolic Events

BackgroundA patent foramen ovale (PFO) has been associated with embolic strokes and transient ischemic attacks (TIAs). Catheter closure of PFO is effective in preventing recurrent events. Residual shunts and procedure or device related complications can occur, including atrial fibrillation and thrombus formation. This study examines the initial experience with a new PFO closure device, the IrisFIT PFO-Occluder (Lifetech Scientific, Shenzhen, China).Methods95 patients with indications for PFO closure underwent percutaneous closure with the IrisFIT PFO-Occluder. The primary endpoint was the rate of accurate device placement with no/small residual shunt at 3 or 6 months follow-up. All patients underwent transoesophageal echocardiography (TEE) after 1 to 6 months. In case of a residual shunt, an additional TEE was performed after 12 months. Clinical follow-up was performed up to a mean of 33.1 ± 3.6 months.ResultsThe device was successfully implanted in 95 (100%) patients with no relevant procedural complications. At final TEE follow-up (7.6 ± 3.9 months) the effective closure rate was 96.8% with 1 moderate and 2 large residual shunts. There were 8 cases of new onset atrial fibrillation and 2 TIAs. There were no cases of device embolization or erosion.ConclusionThe IrisFIT occluder is a new PFO closure device with several advantages compared to other devices. In this small study cohort, technical success rate, closure rate and adverse event rate were comparable to other devices. The rate of new onset atrial fibrillation was higher in comparison to other studies and warrants further investigation.     

Percutaneous atrial shunt closure using the novel Occlutech Figulla device: 6-month efficacy and safety

Background: The Occlutech Figulla Occluder is a new innovative device for percutaneous closure of a patent foramen ovale (PFO) and an atrial septum defect (ASD). We describe the safety and efficacy of this new device at 6‐month follow‐up. Methods: All 82 consecutive patients (51% female, mean age 49.0 ± 13.6 years) who underwent percutaneous PFO (n = 48) or ASD (n = 34) closure between October 2008 and October 2009 were included. Results: Implantation success was 100%. The in‐hospital complications were two new onset supraventricular tachycardia (SVT) (2.4%, both ASD patients), nine minimal groin hematoma's (11.0%, 4 PFO and 5 ASD patients), and one transient ST elevation during the procedure (1.2%, ASD patient). During 6 months follow‐up (n = 79), no major complications or reoccurrences of cerebral thrombo‐embolic events did occur. Seven patients (8.9%, 6 PFO and 1 ASD patient) experienced a new SVT. One patient developed a recurrent cerebral hemorrhage 5 months after ASD closure, which appeared not to be related to the procedure. Using contrast transthoracic echocardiography 6 months after PFO closure (n = 45), a residual shunt was present in 30.2% of the patients (small 25.6%, moderate 4.6%, severe 0%). In the ASD group (n = 34), a residual shunt was observed in 32.5% (small 17.7%, moderate 14.7%, severe 2.9%). Conclusion: The Occlutech Figulla Occluder appears to be easy to use, effective, and safe for percutaneous closure of PFO and ASD. We report a low complication rate but a relative high percentage of small residual shunts 6 months after closure. (J Interven Cardiol 2011;24:264–270)     

Implantation of a second closure device in patients with residual shunt after percutaneous closure of patent foramen ovale.

Percutaneous closure of patent foramen ovale (PFO) in patients with presumed paradoxical embolism yields complete occlusion in > 90% of patients using contemporary closure devices. Patients with a residual shunt after percutaneous PFO closure have been found at increased risk for recurrent paradoxical events. Treatment options for such patients include medical treatment using antiplatelet drugs or oral anticoagulation, surgical device removal and patch closure, and percutaneous implantation of a second closure device. We report our experience with implantation of a second closure device in 10 patients with more than a minimal residual shunt < or = 6 months after percutaneous PFO closure. Procedure and fluoroscopy times were similar for the initial and repeat intervention (32 vs. 30 min and 5 vs. 6 min, respectively; P = NS). There were no procedural complications during implantation of the second closure device. Follow-up transesophageal echocardiography 6 months after the second percutaneous intervention revealed complete PFO closure in nine (90%) patients. Therefore, implantation of a second closure device in patients with persistence of more than a residual shunt after percutaneous PFO closure appears safe and effective.     

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.     

Transcatheter closure of patent foramen ovale associated with paradoxical embolism using the amplatzer PFO occluder: initial and intermediate-term results of the U.S. multicenter clinical trial.

Closure of patent foramen ovale (PFO) has been proposed as an alternative to anticoagulation in patients with presumed paradoxical emboli. We report the immediate and mid-term results of the phase 1 U.S. Multicenter Clinical Trial of patients who underwent transcatheter PFO closure for paradoxical embolism using the new Amplatzer PFO device. Fifty patients (28 male/22 female) underwent catheter closure of their PFOs at a mean age of 41 +/- 11 years. Thirty-six patients had ischemic stroke, 10 had transient ischemic attack, and 4 had peripheral embolism. Seventeen patients had atrial septal aneurysm. The implantation procedure was successful in 49/49 patients; one patient did not have a PFO. Complete closure was seen immediately after the procedure in 26/49 patients; 17 had minimal residual shunt, 4 had moderate and 2 had large residual shunts. The median fluoroscopy time was 10.5 min (2.8-43 min). There were no complications related to the device. One patient developed an arteriovenous fistula at the catheter site requiring surgical repair. At a mean follow-up interval of 16.5 +/- 7.2 months, there were no deaths or recurrent neurological or peripheral embolic events. Eight patients reported an episode of dizziness or palpitations (four of them within 18 days of the procedure). No episodes of atrial dysrhythmias were noted. Contrast bubble study at last follow-up documented complete closure in 45/48 patients; one patient had minimal, one had moderate residual shunt, and one had a large shunt. One patient was lost to follow-up. We conclude that catheter closure of PFO associated with stroke/transient ischemic attack or peripheral embolism using the new Amplatzer PFO device is a safe and effective method in preventing recurrence of such episodes. Randomized clinical trials comparing device closure versus continued medical therapy are underway.     

Sustained long‐term benefit of patent foramen ovale closure on migraine

Objectives : This single‐center, observational, prospective study evaluated the impact of patent foramen ovale (PFO) closure on migraine attacks over time. Background : PFO closure may reduce the frequency and severity of migraine headaches in patients with significant right‐to‐left shunts. Methods : Between May 2000 and September 2009, 305 consecutive patients (mean age, 43 ± 12 years; 54.5% women) with a prior embolic cerebrovascular event underwent PFO closure with the Amplatzer PFO occluder for recurrence prevention. All patients had right‐to‐left shunts; the shunts were associated with migraine symptoms in 77 (25%), either alone (n = 64, 83%) or with aura (n = 13, 17%). Septal aneurysm was present in 15 (19.5%) migraine patients, and 43 (56%) had a previous transient brain ischemic attack. All migraine patients had a computed tomography scan or magnetic resonance imaging, indicating a previous brain ischemic lesion. All 305 patients underwent transthoracic echocardiography with clinical follow‐up at 24 hr, at 3, 6, and 12 months, and then yearly. Results : An acute migraine attack occurred 24–48 hr after PFO closure in 28 (36.4%) of 77 patients. There was a significant reduction (>50%) in the number and intensity of attacks in 46 (60.5%) of 77 patients at the 3‐month follow‐up. At the 12‐month follow‐up, migraine had ceased in 23 (46%) patients, and 20 (40%) had a reduction in the migraine recurrence rate and disabling symptoms. These results were maintained at follow‐up (mean, 28 ± 27 months). There was overall improvement in migraine in 89% of the treated patients. Conclusions : Percutaneous PFO closure in migraineurs may provide beneficial mid‐term and long‐term results, with significant reduction in the intensity and frequency of headache symptoms. © 2010 Wiley‐Liss, Inc.     

Safety and feasibility of percutaneous closure of patent foramen ovale without intra-procedural echocardiography in 825 patients

BACKGROUND: Percutaneous closure of patent foramen ovale (PFO) is generally performed using intra-procedural guidance by transoesophageal (TEE) or intracardiac (ICE) echocardiography. While TEE requires sedation or general anaesthesia, ICE is costly and adds incremental risk, and both imaging modalities lengthen the procedure. METHODS: A total of 825 consecutive patients (age 51 +/- 13 years; 58% male) underwent percutaneous PFO closure solely under fluoroscopic guidance, without intra-procedural echocardiography. The indications for PFO closure were presumed paradoxical embolism in 698 patients (95% cerebral, 5% other locations), an embolic event with concurrent aetiologies in 47, diving in 51, migraine headaches in 13, and other reasons in 16. An atrial septal aneurysm was associated with the PFO in 242 patients (29%). RESULTS: Permanent device implantation failed in two patients (0.2%). There were 18 procedural complications (2.2%), including embolization of the device or parts of it in five patients with successful percutaneous removal in all cases, air embolism with transient symptoms in four patients, pericardial tamponade requiring pericardiocentesis in one patient, a transient ischaemic attack with visual symptoms in one patient, and vascular access site problems in seven patients. There were no long-term sequelae. Contrast TEE at six months showed complete abolition of right-to-left shunt via PFO in 88% of patients, whereas a minimal, moderate or large residual shunt persisted in 7%, 3%, and 2%, respectively. CONCLUSIONS: This study confirms the safety and feasibility of percutaneous PFO closure without intra-procedural echocardiographic guidance in a large cohort of consecutive patients.     

A case of platypnea-orthodeoxia syndrome caused by the interaction between the presence of corrected transposition of the great arteries and patent foramen ovale

A 42-year-old was admitted to our institution for recurrent episodic dyspnea on exertion. The patient had also a history of recurrent transient ischemic attacks. Careful history taking revealed that she developed dyspnea in an upright position, whereas the symptoms were relieved in a supine position (platypnea). The patient was given the diagnosis of platypnea-orthodeoxia syndrome. Transthoracic echocardiography showed cardiac situs solitus levocardia with great artery transposition with intact interventricular septum, patent foramen ovale (PFO) and moderate right atrial dilatation. Agitated saline contrast injection demonstrated the presence of spontaneous right-to-left shunt. The patient underwent transcatheter closure of PFO. After percutaneous closure of PFO patient became asymptomatic and hypoxemia induced by orthostatic conditions did not appear again. A transthoracic echocardiography performed after two months, showed the complete closure of PFO, without residual shunt.     

Transnasal transesophageal echocardiography: A new approach for the PFO occlusion in awake patients

Objectives : To reduce risks, discomfort, cost, and operative time for percutaneous patent foramen ovale (PFO) closure, we propose to perform this procedure under transesophageal echo‐guidance using a 10 Fr. catheter introduced through nasal way (TEENW). Background : Transesophageal or intracardiac echocardiography is commonly used to guide percutaneous PFO closure. Sedation needed quite frequently during transesophageal echocardiography, increased patients' discomfort, procedure prolongation, costs, use of both femoral veins, and additional intracardiac manipulations are the main limitations of standard techniques. Methods : We enrolled 20 consecutive patients with a history of cerebral ischemia and PFO with right‐to‐left shunt. In 15 patients Amplatzer® PFO occluder was used, whereas in five patients with longer PFO tunnel (>10 mm) Cardia Intrasept® was selected. Without sedation, a multifrequency monoplane probe, developed for intracardiac echocardiography, was introduced into the nostril and advanced forward the esophagus. Then under echo guidance, the closing device was presented, opened and released. Results : Procedure lasted for an average of 33.3 min, and no complications were seen. At procedure's completion, six patients showed persistence of reduced shunt during Valsalva manoeuvre. At six‐month follow‐up, shunts disappeared in all patients. Conclusion : TEENW is safe and well tolerated, and images' quality is high enough to deserve widespread adoption of this technique for PFO closure. © 2008 Wiley‐Liss, Inc.     

Encerramento percutâneo de defeitos do septo interauricular guiado por ecocardiograma intracardíaco − A experiência de um centro

IntroductionDevice closure of interatrial communications has become a well-established technique to treat left-to-right shunt associated with atrial septal defect (ASD) and to prevent paradoxical embolism in patients with patent foramen ovale (PFO). Guidance by transesophageal echocardiography (TEE) is the standard practice but intracardiac echocardiography (ICE) is a feasible and safe alternative for monitoring these procedures.ObjectivesTo report our experience in the percutaneous closure of ASD and PFO guided by ICE.MethodsWe retrospectively reviewed all patients with ASD or PFO who underwent percutaneous closure guided exclusively by ICE between January 2008 and December 2010. All patients were followed clinically with regular echocardiographic evaluation (at discharge, one month, three, six and twelve months) to exclude residual shunt and device malposition.ResultsA total of 127 patients (mean age 46.6±12.2 years; 71% female) underwent transcatheter device closure of ASD or PFO during the study period. Device deployment with ICE monitoring was 100% successful, with a low rate of complications and eliminating the need for additional imaging techniques.ConclusionsICE provides anatomical detail of ASD/PFO and cardiac structures, facilitating congenital cardiac interventional procedures. It eliminates the major drawbacks associated with TEE and enables the interventional cardiologist to control all aspects of the procedure without relying on additional echocardiographic support.     

Patent foramen ovale closure in India; Feasibility,challenges and mid-term outcomes

Patent foramen ovale closure (PFO) is an underutilized therapy, and our study explored the challenges and feasibility of PFO closure in the Indian setting.Eighty patients with Embolic Stroke of Undetermined Source (ESUS) were screened by transcranial Doppler (TCD) for PFO. Twenty-nine patients underwent successful closure.High-risk features of a long tunnel, inter-atrial septal aneurysm, and large defect were present in 31%, 28%, and 59%. Transcranial Doppler had a sensitivity and specificity of 78% and 53% (p = 0.02) to detect PFO. Anticoagulation was withdrawn in 85% of patients post closure. Two patients had residual shunts at follow-up of 19 (9,34) months.     

Transcranial Doppler Quantification of Residual Shunt after Percutaneous Patent Foramen Ovale Closure. Comparison of Two Devices

Background: Recurrent paradoxical embolism after catheter‐based closure of right‐to‐left shunt (RLS) can be related to residual RLS. To improve closure success, we need a better understanding of the anatomic and device‐related factors associated with closure efficacy. Methods: Patients with cryptogenic neurologic events and severe RLS (Valsalva Spencer transcranial Doppler [TCD] grade 5/5+) who underwent patent foramen ovale (PFO) closure by either central pin (Amplatzer^® PFO [A‐PFO]) or central occluding (Amplatzer^® SO [A‐SO]) devices were evaluated for residual shunt by quantitative TCD evaluation at 3 months. The findings were correlated with atrial septal aneurysm (ASA), device type, and device size. Results: We closed 628 consecutive patients with either the A‐PFO (n = 327) or A‐SO (n = 301) device. The frequency of large defects, small defects, and ASA was 12%, 88%, and 44% of cases, respectively. Severe residual shunt was detected in 13% of A‐PFO and 7% of A‐SO recipients (P = 0.005). This difference was attributable to a much higher frequency of severe residual shunt among patients with large defects closed with the A‐PFO compared to the A‐SO device (12 out of 29 [41%] vs. 3 out of 42 [7%], respectively; P < 0.001). There was no significant difference in device failure frequency for small defects. The presence of ASA increased the frequency of severe residual shunt compared to those without this feature (36 out of 275 [13%] vs. 28 out of 353 [8%], respectively; P = 0.046) but did not influence device‐related differences. Conclusions: (1) Both noncentering and central occluding closure devices effectively reduce RLS after PFO closure. (2) Large PFO defects with or without ASA have lower residual shunt grades at 3 months when closed by central occluding devices. (J Interven Cardiol 2010;23:575–580)     

Closure of patent foramen ovale for paradoxical emboli: intermediate-term risk of recurrent neurological events following transcatheter device placement

OBJECTIVES: We report the largest and the longest follow-up to date of patients who underwent transcatheter patent foramen ovale (PFO) closure for paradoxical embolism. BACKGROUND: Closure of a PFO has been proposed as an alternative to anticoagulation in patients with presumed paradoxical emboli. METHODS: Data were collected for patients following PFO closure with the Clamshell, CardioSEAL or Buttoned Devices at two institutions. RESULTS: There were 63 patients (46 +/- 18 years) with a follow-up of 2.6 +/- 2.4 years. Fifty-four (86%) had effective closure of the foramen ovale (trivial or no residual shunt by echocardiography) while seven (11%) had mild and two (3%) had moderate residual shunting. There were four deaths (leukemia, pulmonary embolism, sepsis following a hip fracture and lung cancer). There were four recurrent embolic neurological events following device placement: one stroke and three transient events. The stroke occurred in a 56-year-old patient six months following device placement. A follow-up transesophageal echocardiogram showed a well seated device without residual shunting. Two of the four events were associated with suboptimal device performance (one patient had a significant residual shunt and a second patient had a "friction lesion" in the left atrial wall associated with a displaced fractured device arm). The risk of recurrent stroke or transient neurological event following device placement was 3.2% per year for all patients. CONCLUSION: Transcatheter closure of PFO is an alternative therapy for paradoxical emboli in selected patients. Improved device performance may reduce the risk of recurrent neurological events. Further studies are needed to identify patients most likely to benefit from this intervention.     

卵圆孔未闭结构特征对介入治疗封堵器选择的影响

目的 探讨卵圆孔未闭（PFO）结构特征对介入治疗封堵器选择的影响。方法 回顾性分析98例拟进行PFO封堵治疗患者临床资料,按经胸超声心动图(TTE)和（或）经食管超声心动图(TEE)检查结果分为简单PFO组和复杂PFO组,比较两组患者封堵器的选择及疗效。结果 PFO患者98（男41,女57）例,年龄8~74(41±14)岁。92例封堵成功,6例未成功,其中导丝无法到达左房4例,肺动静脉瘘1例,并发肺动脉高压患者1例。手术总成功率为94%。简单PFO组42例,复杂PFO组56例,简单PFO以18/25 mm PFO封堵器为主,复杂PFO以30/30 mm和25/35 mm PFO封堵器为主,两组间封堵器的选择有显著差异（P<0.01）。术后半年复查经胸超声心动图声学造影（cTTE）,完全堵闭65例（71%）,Valsalva动作后有右向左分流（RLS）27例（29%）,其中少量20例(22%),中量4例(4%),大量3例(3%)。大量RLS均发生在复杂PFO组应用30/30 mm和25/35 mmPFO封堵器的患者。复杂PFO组有1例新发阵发性心房纤颤。结论 封堵器选择与PFO特征有关,简单PFO以18/25 mm PFO封堵器为主,复杂PFO以30/30 mm和25/35 mm PFO封堵器为主。     

A suture not always the ideal solution: Problems encountered in developing a suture‐based PFO closure technique

Objectives: To summarize our experiences with the first‐in‐man suture‐based patent foramen ovale (PFO) closure technique. Background: PFO is often present with the occurrence of cryptogenic stroke and migraine with aura. Successful PFO closure can be performed percutaneously using catheter techniques with many different closure devices. The described novel closure system is intended to deliver, via endovascular access, a suture into the atrial septal wall tissue for closure of PFO. Methods: Eleven patients, between 22 and 58 years of age (mean 46.6 ± 9.6), who had a cryptogenic ischemic stroke, TIA, or a peripheral embolism and a PFO were considered for percutaneous closure with this technique. Results: The mean stretched diameter of the defect evaluated during balloon sizing was 8.8 ± 0.4 mm (range 7–12.5). Delivery of the suture was successful in all patients. No intraprocedural complications occurred. During the follow up, complete closure could be achieved in one patient. Six patients with significant residual shunting during follow‐up had successful closure using a conventional device. One patient was lost for follow‐up after the 3‐month visit. The residual shunt in the remaining three patients was very small and they declined to be treated with a conventional device. No complications occurred during the follow up. Conclusions: Transcatheter application of a suture for closure of PFO is technically feasible and safe. However, despite successful suturing of the septum primum to the septum secundum, the PFO did not close in most of the patients. © 2008 Wiley‐Liss, Inc.     

Prevalence of patent foramen ovale and usefulness of percutaneous closure device in carcinoid heart disease

The aim of this study was to assess (1) the incidence of patent foramen ovale (PFO) in carcinoid syndrome (CS) and (2) the feasibility of percutaneous closure procedure in selected patients with CS. One hundred eight patients were prospectively studied: 54 with CS and an age- and gender-matched control group. All patients underwent conventional and contrast echocardiography. Patients with clinical signs of dyspnea (New York Heart Association class > or =III), cyanosis, carcinoid heart disease (CHD), and severe PFO were referred for the percutaneous closure of PFO. The prevalence of PFO was 41% in patients with CS and 22% in the control group (p = 0.03) and was significantly higher in patients with CHD (59%, p = 0.009). Four patients (14% of those with CHD) were referred for the percutaneous closure of PFO, and 3 patients ultimately underwent PFO closure (using Amplatzer septal occluders). At 6-month follow-up, New York Heart Association class was improved in all patients, as well as arterial blood gas results (p = 0.04) and 6-minute walking distance (p = 0.03), but all patients presented residual right-to-left shunts. In conclusion, this prospective study demonstrates that in patients with CHD, the prevalence of PFO is high and that percutaneous closure of PFO is feasible, with a reduction in symptoms but with residual shunting.     

Transcatheter closure of postinfarction ventricular septal defects using the new Amplatzer muscular VSD occluder: Results of a U.S. Registry.

The objective of this study was to assess the immediate and mid-term results of transcatheter closure of postinfarct muscular ventricular septal defects (VSDs) using the new Amplatzer postinfarct muscular VSD device (PIMVSD). Ventricular septal rupture occurs in 0.2% of myocardial infarcts and remains associated with very high morbidity and mortality. Data were prospectively collected for 18 patients who underwent attempted device closure of postinfarction VSDs between 2000 and 2003. Five patients underwent the closure in the acute phase (within 6 days from the infarct); the remaining patients underwent closure on day 14-95 after the diagnosis of the infarct. Outcome parameters included procedural success, evidence of residual shunts on echocardiography, and occurrence of procedure-related complications. The procedure was successful in deploying a device across the VSD in 16 of 18 patients. The 30-day mortality was 28%. Eleven patients are still alive and have been followed up for a median of 332 days. Two patients required a second procedure to close a residual VSD. At the most recent outpatient follow-up, the VSD was completely closed in two patients, six patients had a trivial or small residual shunt, and two patients had a moderate residual shunt. We conclude that percutaneous device closure of postinfarction VSDs using the Amplatzer PIMVSD occluder appears to be safe and effective. Further trials are required to assess long-term efficacy and compare the results with those of surgical closure.     

Outcome after percutaneous closure of a patent foramen ovale using the Intrasept™ device

Objectives : This multi‐centre study reports safety and efficacy of percutaneous patent foramen ovale (PFO) closure, using the fourth generation Intrasept? device. Background : PFO has been associated with paradoxical embolism and cryptogenic stroke. Percutaneous PFO closure seems to reduce the risk for recurrent paradoxical thrombo‐embolism. Currently, different devices are used for PFO closure. Methods : Patients, who underwent a PFO closure with the Intrasept device (Cardia, Eagan, MN) between July 2002 and September 2006, were included in the study. The primary endpoint was defined as reoccurrence of stroke, transient ischemic attack (TIA), or peripheral thrombo‐embolism. Peri‐procedural and mid‐term complications were reported. Results : Four‐hundred thirty patients (mean age 50.7 ± 13.0 years, 231 men) underwent closure. The indications were cryptogenic stroke (69.8%), TIA (23.5%), peripheral embolism (3.3%), and other (3.5%). The median follow‐up time was 0.8 years, range 3.9 years. The primary endpoint occurred in 0.5% for stroke, in 2.5% for TIA, and in none for peripheral embolism. Peri‐procedural complications were reported in 11.5% of cases, from which 0.2% was defined as major. No severe complications occurred during mid‐term follow‐up. A residual shunt was present in 12.5% of patients who did not suffer from a recurrent event, compared to 36.4% of patients who reached the primary endpoint (P = 0.04). Conclusion : This multi‐centre study suggests that percutaneous closure of a symptomatic PFO with the fourth generation Intrasept device is safe and might be effective to prevent the recurrence of paradoxical thrombo‐embolic events. © 2008 Wiley‐Liss, Inc.