Paravalvular leak closure under intracardiac echocardiographic guidance.

OBJECTIVES: The objective of this study was to determine the safety and efficacy of intracardiac echocardiography (ICE) to guide percutaneous paravalvular leak (PVL) closure. BACKGROUND: PVL following surgical valve replacement occurs in 2%-15% of patients. Percutaneous treatment is an accepted management strategy in patients deemed to be too high risk for redo surgery. This is most commonly performed with transesophageal (TOE) guidance requiring general anesthesia that both potentially further increase the risk of intervention. ICE can be used to guide intervention, facilitating procedures to be performed under local anesthesia without esophageal intubation potentially making procedures shorter and safer and further enabling the treatment of patients that may have been turned down for intervention. METHODS: All patients that underwent ICE-guided percutaneous transcatheter PVL closure between 2006 and 2016 at the John Radcliffe Hospital, Oxford, United Kingdom were retrospectively analyzed. RESULTS: Twenty-one procedures were performed in 18 patients during the study period. Fourteen patients (77.8%) underwent successful ICE guided PVL closure. There were no ICE-related complications. Eleven patients (78.6%) reported symptomatic improvement of at least one New York Heart Association (NYHA) Class and the remaining 3 patients had no change. No patient demonstrated objective evidence of persistent hemolysis following successful closure. There was one death within 30 days of the procedure and 1 year survival was 71.4%. CONCLUSIONS: Percutaneous paravalvular leak closure guided by ICE without the requirement of general anesthesia is feasible, safe, and associated with acceptable procedural success rates.

Percutaneous Device Closure of Paravalvular Leak: Combined Experience From the United Kingdom and Ireland.

BACKGROUND: Paravalvular leak (PVL) occurs in 5% to 17% of patients following surgical valve replacement. Percutaneous device closure represents an alternative to repeat surgery. METHODS: All UK and Ireland centers undertaking percutaneous PVL closure submitted data to the UK PVL Registry. Data were analyzed for association with death and major adverse cardiovascular events (MACE) at follow-up. RESULTS: Three hundred eight PVL closure procedures were attempted in 259 patients in 20 centers (2004-2015). Patient age was 67±13 years; 28% were female. The main indications for closure were heart failure (80%) and hemolysis (16%). Devices were successfully implanted in 91% of patients, via radial (7%), femoral arterial (52%), femoral venous (33%), and apical (7%) approaches. Nineteen percent of patients required repeat procedures. The target valve was mitral (44%), aortic (48%), both (2%), pulmonic (0.4%), or transcatheter aortic valve replacement (5%). Preprocedural leak was severe (61%), moderate (34%), or mild (5.7%) and was multiple in 37%. PVL improved postprocedure (P<0.001) and was none (33.3%), mild (41.4%), moderate (18.6%), or severe (6.7%) at last follow-up. Mean New York Heart Association class improved from 2.7±0.8 preprocedure to 1.6±0.8 (P<0.001) after a median follow-up of 110 (7-452) days. Hospital mortality was 2.9% (elective), 6.8% (in-hospital urgent), and 50% (emergency) (P<0.001). MACE during follow-up included death (16%), valve surgery (6%), late device embolization (0.4%), and new hemolysis requiring transfusion (1.6%). Mitral PVL was associated with higher MACE (hazard ratio [HR], 1.83; P=0.011). Factors independently associated with death were the degree of persisting leak (HR, 2.87; P=0.037), New York Heart Association class (HR, 2.00; P=0.015) at follow-up and baseline creatinine (HR, 8.19; P=0.001). The only factor independently associated with MACE was the degree of persisting leak at follow-up (HR, 3.01; P=0.002). CONCLUSION: Percutaneous closure of PVL is an effective procedure that improves PVL severity and symptoms. Severity of persisting leak at follow-up is independently associated with both MACE and death. Percutaneous closure should be considered as an alternative to repeat surgery.

Percutaneous left atrial appendage occlusion using different technologies in the United Kingdom: A multicenter registry.

OBJECTIVES: This study aimed at assessing the feasibility and long-term efficacy of left atrial appendage occlusion (LAAO) in a "real world" setting. BACKGROUND: Although LAAO has recently emerged as an alternative to oral anticoagulants in patients with atrial fibrillation for the prevention of thromboembolic stroke, "real world" data about the procedure with different devices are lacking. METHODS: Eight centers in the United Kingdom contributed to a retrospective registry for LAAO procedures undertaken between July 2009 and November 2014. RESULTS: A total of 371 patients (72.9 ± 8.3 years old, 88.9% males) were enrolled. The overall procedure success was 92.5%, with major events in 3.5% of cases. The device choice was Watchman in 63% of cases, Amplatzer Cardiac Plug in 34.7%, Lariat in 1.7%, and Coherex WaveCrest in 0.6%. A significant improvement in procedure success (from 89.2% to 95.7%; P = 0.018) and reduction of acute major complications (from 6.5% to 0.5%; P = 0.001) were observed between procedures in the first and the second half of the recruitment time. An annual 90.1% relative risk reduction (RRR) for ischemic stroke, an 87.2% thromboembolic events RRR, and a 92.9% major bleeding RRR were observed, if compared with the predicted annual risks based on CHADS2, CHA2DS2-Vasc, and HAS-BLED scores, respectively, over a follow-up period of 24.7 ± 16.07 months. CONCLUSIONS: LAAO can be performed safely in a real world setting with good implant success rates and procedural outcomes. The long-term benefits of the procedure are reassuring in terms of both ischemic events and avoidance of severe bleeding associated with anticoagulation in this patient group. © 2016 Wiley Periodicals, Inc.

Patent foramen ovale closure with the Gore septal occluder: initial UK experience.

OBJECTIVES: To report procedural outcome and short-term follow-up data for the Gore septal occluder (GSO), a new device for closure of patent foramen ovale (PFO). BACKGROUND: Transcatheter closure of PFO is an established treatment modality but no current device provides a perfect solution. The GSO has a number of design features, which make it potentially attractive for closure of defects in the atrial septum. METHODS: Data from 9 centers in the United Kingdom implanting the GSO device, submitted to an electronic registry for evaluation. RESULTS: Two hundred twenty-nine patients undergoing PFO closure from June 2011 to October 2012 were included. Indications for closure were secondary prevention of paradoxical cerebral emboli (83.4%), migraine (2.1%), platypnoea orthodeoxia (3.9%), and other (10.5%). Median PFO size was 8 mm and 34 and 39%, respectively, had long tunnel anatomy or atrial septal aneurysms. A GSO was successfully implanted in all cases. A single device was used in 98% but in 4 patients the initial device was removed and a second device required. Procedural complications occurred in 3% and later complications (e.g., atrial fibrillation, atrial ectopics, and device thrombus) in 5.7% of cases. All patients have undergone clinical and echocardiographic follow-up and all devices remain in position. Early bubble studies (median 0 months) with Valsalva maneuver in 67.2% were negative in 89%. CONCLUSIONS: The GSO is an effective occlusion device for closure of PFO of all types. Longer-term follow-up particularly to document later closure rates are required.

Initial use of the new GORE(®) septal occluder in patent foramen ovale closure: implantation and preliminary results.

BACKGROUND: A number of devices are available for percutaneous closure of a clinically significant patent foramen ovale (PFO). The new GORE(®) septal occluder (GSO) is a nonself-centering device consisting of an expanded polytetrafluoroethylene tube supported by a frame of nitinol wire conforming into a double disk. This study reports the first clinical GSO implantation experience. METHODS: GSO implantation in 20 consecutive patients is reported. Inclusion criteria were all patients referred with a significant PFO implicated in paradoxical embolism or transient right to left shunting causing desaturation. Procedures were performed under local anaesthesia and intracardiac echocardiography (ICE) in addition to fluoroscopy. Procedural data, acute and early closure rates were examined. RESULTS: All patients underwent successful day-case device implantation. Eleven patients had previous stroke, five had transient ischemic attacks, two had a history suspicious of PFO-related desaturation, and two had a history suspicious of PFO-related peripheral thromboembolism. Acute closure rates on IVC injection bubble testing were 100% at implant and 100% (14/14) at 1 month. Average PFO balloon size was 8.0 ± 3.6(range 2.0-16.7) mm, mean fluoroscopic implantation time 3.0 ± 1.7(range 0.7-6.3) min, radiation dose 283 ± 340 (range 6-1,431) µGym(2), and total procedural time 34.8 ± 8.0 (range 22-53) min. 5 × 20 mm(2), 7 × 25 m(2), 8 × 30 mm(2) GSO devices were implanted, aiming for device size at least twice balloon PFO size. Cases included aneurysmal septums with up to 30 mm deviation and tunnels up to 12 mm long. Removal and repositioning of two devices was performed on two occasions after uncertainty about device locking. At 1 month follow-up, two patients had brief self-terminating episodes of suspected atrial fibrillation, all had normal resting ECGs. No thromboembolic/neurological events were reported. CONCLUSIONS: The GSO can be implanted under local anaesthesia and ICE with low procedural and fluoroscopy times with high procedural success as a day case. No residual shunts were seen. This initial experience suggests that it is a safe and effective device for PFO closure.

Echocardiographic assessment and critical care management of peri-partum women with unexpected left ventricular failure.

Introduction: Cardiac disease remains the largest single cause of maternal death. Whilst uncommon, left ventricular failure during pregnancy and delivery can be devastating to both mother and child. Echocardiography can play a significant role in rapidly establishing a diagnosis, guiding initial therapy and then monitoring response. Clinical vignettes: The history, presentation and management of three cases of peri-partum left ventricular failure is examined: stress cardiomyopathy in a 34 year old with twins, left ventricular dysfunction secondary to pre-eclampsia in a 22 year old with a singleton pregnancy and a true peri-partum cardiomyopathy in a 42 year old with IVF twins. The defining risk factors, presenting characteristics and echocardiographical findings for each pathology are highlighted. Conclusion: Echocardiography is playing an increasingly important role in the immediate assessment and management of left ventricular failure. This is especially true in the peri-partum woman, where establishing the correct therapy is both challenging and crucial due to the significant cardiovascular changes that occur around the time of delivery. To this end we believe that echocardiography should be rapidly available to guide the management of these patients by a multidisciplinary team made up of obstetricians, cardiologists, anaesthetists and intensive care physicians.

Intracardiac echocardiography off piste? Closure of the left atrial appendage using ICE and local anesthesia.

Left atrial appendage (LAA) occlusion is increasingly accepted to reduce the risk of stroke in patients with atrial arrhythmia who are unsuitable for routine anticoagulation. It is generally performed under general anesthesia, guided by transoesophageal echocardiography with accurate imaging being essential for correct deployment of the device. We present a case where LAA occlusion was done under local anesthesia in a high-anesthetic risk patient, using novel placement of an intracardiac echo probe via a Mullins sheath in the right ventricular outflow tract and pulmonary artery. This allowed accurate visualization of device deployment in the LAA. This technique may increase the spectrum of patients who may benefit from the procedure and decrease procedure time, fluoroscopy, and procedure-related morbidity.

Left atrial appendage closure with Amplatzer cardiac plug in atrial fibrillation: initial European experience.

BACKGROUND: In most patients with atrial fibrillation (AF) and stroke, there is thrombotic embolization from the left atrial appendage (LAA). Percutaneous closure of the LAA is a novel alternative for the treatment of patients with AF at a high risk of stroke, in whom long-term anticoagulation therapy is not possible or not desired. This study details the initial experience with the Amplatzer Cardiac Plug (ACP) in humans. METHODS: Investigator-initiated retrospective preregistry data collection to evaluate procedural feasibility and safety up to 24 hr after implantation of the ACP, a nitinol device designed for percutaneous trans-septal implantation in LAA of patients with paroxysmal, permanent, or persistent AF. RESULTS: In 137 of 143 patients, LAA occlusion was attempted, and successfully performed in 132 (96%). There were serious complications in 10 (7.0%) patients (three patients with ischemic stroke; two patients experienced device embolization, both percutaneously recaptured; and five patients with clinically significant pericardial effusions). Minor complications were insignificant pericardial effusions in four, transient myocardial ischemia in two, and loss of the implant in the venous system in one patient. CONCLUSION: The implantation of the ACP device is a feasible method for percutaneous occlusion of the LAA.

Prominence of the Eustachian valve in paradoxical embolism.

AIMS: to investigate the relationship between Eustachian valve (EV) length and degree of atrial septal movement in patients with patent foramen ovale (PFO) and presumed paradoxical cerebral embolism. PFO is a well-established risk factor for cryptogenic stroke. However, due to the high prevalence of PFO, many of these are bystanders rather than true pathological entities. Other studies have sought to define which patients with PFO are particularly at risk of cryptogenic stroke by measuring various parameters of right atrial anatomy. We investigated the relationship between EV length and atrial septal movement. METHODS AND RESULTS: measurements of EV length and atrial septal movement were made prospectively from 72 consecutive patients referred to our centre for PFO closure following presumed cryptogenic stroke, by intracardiac phased array echocardiography. The most significant finding from this study was that patients with fewer than 10 mm atrial septal movement had significantly longer EVs than those in whom there was >10 mm septal movement (P = 0.003). The mean EV length with >10 mm septal movement is 6.35 mm, and 13.33 mm with fewer than 10 mm movement. The prevalence of septal movement beyond 10 mm was significantly less in our series than in previously published papers. CONCLUSION: we propose that while a large degree of atrial septal movement significantly increases propensity to cerebral embolism in patients with PFO, its absence does not negate this risk. We have shown that long EV may function independently from atrial septal movement to potentiate paradoxical embolism.

Stent-graft repair of coronary vein graft aneurysm.

The authors describe treating a 6-cm right coronary artery bypass graft aneurysm that was causing recurrent angina. With use of the combined skills of interventional radiologists and cardiologists, the aneurysm was successfully occluded by using a stent-graft typically used to treat aneurysms in the peripheral circulation. One month after the procedure, the aneurysm had sealed at follow-up computed tomographic angiography.

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.

Percutaneous closure of an iatrogenic atrial septal defect.

We report the successful percutaneous closure of an iatrogenic atrial septal defect in a 71-year-old woman. The patient had undergone mitral valve replacement and coronary artery bypass grafting, followed by redo surgery to repair a para-valvular mitral leak. Post-operatively she remained significantly limited by dyspnoea. Repeat transoesophageal echocardiography documented a large iatrogenic atrial septal defect. The patient underwent percutaneous, trans-femoral closure of the defect using the Helex septal occluder (W.L. Gore, Newark, Delaware, USA) with dramatic clinical improvement.

Ventricular septal rupture following abciximab infusion.

Ventricular septal rupture is a rare complication of myocardial infarction. Despite a significant reduction in its incidence with reperfusion therapy, thrombolysis has been implicated in the pathogenesis of septal rupture. There is little information regarding the impact of glycoprotein IIb-IIIa receptor blockers on ventricular septal rupture. We report a case of rupture of the ventricular septum occurring after treatment with the glycoprotein IIb-IIIa receptor blocker abciximab, in the absence of thrombolysis.

Mammoth interatrial septal aneurysm in the ICE age.

BACKGROUND: Intracardiac echocardiography (ICE) is a useful imaging modality that is now being used more widely to assist in the percutaneous closure of atrial septal defects (ASD) and patent foramen ovales (PFO). CASE PRESENTATION: A 42 year old lady with a history of transient ischaemic attacks and migraine underwent percutaneous closure of an ASD. Intraprocedural ICE demonstrated a mammoth billowing multiperforated interatrial septal aneurysm in association with a secondum ASD. CONCLUSION: ICE provides excellent adjuvant imaging during percutaneous closure of intracardiac shunts, in this case demonstrating a 'mammoth' interatrial septal aneurysm.