Left Atrial Appendage Occlusion: Past, Present and Future.

There are several situations whereby oral anticoagulation may be unsuitable for stroke prevention in patients with atrial fibrillation (AF). Percutaneous left atrial appendage (LAA) occlusion has received much attention in this area. Various devices have already been developed and tested for this purpose. Data from registries and cohort studies have indicated favourable short- and long-term outcomes with LAA occlusion, and several international guidelines recommend its use in AF patients with contraindications to oral anticoagulation. However, prospective controlled trials in this very population are lacking. Furthermore, while modelling studies on cost analyses have suggested that LAA occlusion may be a cost-effective strategy compared with standard medical therapy, these have not been performed in high-risk patients who may have limited survival in the medium to long term. Thus, while LAA occlusion offers promise, there is a strong need for additional research to investigate its exact role, its long-term outcomes and cost efficacy.

Patent foramen ovale with complex anatomy: Comparison of two different devices (Amplatzer Septal Occluder device and Amplatzer PFO Occluder device 30/35).

BACKGROUND: Patent foramen ovale (PFO) closure after a cryptogenic cerebral ischemic event is a routinely procedure. The most used device is Amplatzer™ PFO Occluder 25 mm, but PFOs with complex anatomy require larger device for closure. We compared Amplatzer™ Septal Occluder (ASO) device versus Amplatzer™ PFO Occluder 30 or 35 mm (A-PFO 30/35) about the safety of procedure and the presence of residual shunt during the follow-up. METHODS: From June 2002 to July 2016, 355 patients (pts) with PFO undergone closure at our institution. Among these ones, 70 pts (19.7%) had a PFO with complex anatomy and a single device with greater diameter was implanted. In these cases, the following devices were used: Gore® Septal Occluder (GSO) in 4 pts; ASO device in 33 pts (group I) and A-PFO 30/35 in 33 pts (group II). Patients treated with GSO device were excluded by our analysis. RESULTS: Comparing group I and group II, there weren't complications during the procedures. Two patients of group II were lost at follow-up. At last follow-up, 1 pt of group I (3%) and 10 pts of group II (32.3%) had a residual shunt (p < 0.01). 7 of 10 pts of group II and the only 1 of group I with residual shunt underwent a complete closure by Amplatzer™ Vascular Plug (AVP) devices. CONCLUSIONS: ASO devices and A-PFO 30/35 devices are both safe to close complex PFO; but A-PFO 30/35 is associated with a more incidence of residual shunt.

Transesophageal echocardiography and fluoroscopy for percutaneous closure of atrial septal defects: A comparative study.

The aim of the study was to compare transesophageal echocardiography (TEE) and fluoroscopy for percutaneous atrial septal defect (ASD) closure.This was a retrospective analysis of children who underwent percutaneous ASD closure. The procedure was guided by TEE without fluoroscopy in 130 patients (TEE group) and by fluoroscopy in 163 patients (fluoroscopy group). Baseline demographic/clinical characteristics were recorded. Patients were followed until hospital discharge. Outcomes were procedure duration, peri/postoperative complications, hospital stay, and costs.The TEE and fluoroscopy groups showed no significant differences in age (71.7 ±â€Š40.7 vs 62.5 ±â€Š38.8 months), male/female ratio (54/76 vs 66/97), weight (22.0 ±â€Š12.0 vs 20.1 ±â€Š9.0 kg), ASD diameter (9.9 ±â€Š4.2 vs 9.3 ±â€Š3.9 cm), distances to the superior vena cava (13.4 ±â€Š4.6 vs 13.3 ±â€Š4.2 cm), inferior vena cava (13.4 ±â€Š4.3 vs 13.9 ±â€Š4.1 cm) and atrial septal roof (12.1 ±â€Š4.0 vs 12.3 ±â€Š3.2 cm), or atrial septal size (38.2 ±â€Š6.2 vs 39.4 ±â€Š26.6 cm); distance to the mitral valve was greater in the TEE group (13.2 ±â€Š4.4 vs 11.3 ±â€Š3.9 cm; P < .001). The TEE and fluoroscopy groups showed no significant differences in occlusion device size (14.3 ±â€Š4.6 vs 13.8 ±â€Š4.0 cm) or sheath size (8.7 ±â€Š1.8 vs 8.7 ±â€Š0.9 cm), but procedure duration was shorter in the TEE group (21.5 ±â€Š14.6 vs 28.6 ±â€Š10.9 minutes; P < .001). Postoperative fever (>38°C) occurred less frequently in the TEE group than in the fluoroscopy group (0.8% vs 9.2%; P < .001); there were no significant differences for the other complications. No patient had postoperative residual shunt, occlusion device shedding/displacement, or pericardial effusion. The TEE group had longer hospital stay (3.2 ±â€Š0.6 vs 2.9 ±â€Š0.6 days; P < .001) and higher procedure cost (29,687 ±â€Š4218 vs 28,530 ±â€Š1668 CNY (China Yuan); P = .002) than the fluoroscopy group.TEE-guided percutaneous ASD closure can be used as an alternative to fluoroscopy-guided procedures and avoids the use of radiation or contrast agents.

Left atrial appendage occlusion with lambre in atrial fibrillation: Initial European experience.

BACKGROUND: We here report the first European experience with the novel LAmbre left atrial appendage (LAA) occluder, a self-expanding device consisting of an umbrella and a cover connected by a central waist. METHODS AND RESULTS: A total of 60 patients (74.4 ±â€¯8.3 years; 66.7% men; CHA2DS2-VASc: 4.0 ±â€¯1.6, HAS-BLED score: 3.2 ±â€¯1.3) with atrial fibrillation and contraindications to oral anticoagulation underwent left atrial appendage occlusion (LAAO) with the LAmbre device at two German centers between November 2013 and September 2015. Device success defined as correct placement of the device was achieved in all patients (100%). Resizing of the device was necessary in 3 (5%) patients. Device-related complications included 2 (3.3%) pericardial effusions on day 8 and 33 after the index procedure requiring pericardiocentesis. Transesophageal echocardiography at 6 months showed complete sealing of the LAA (residual jet flow of <5 mm) in 51/54 (94.4%) patients. No device-related thrombus was documented. At 12 months transient ischemic attack was observed in 1 patient (1.6%) and minor bleeding in 3 patients (5%). CONCLUSIONS: Although minimizing procedure-related complications remains challenging, LAAO with the LAmbre showed high device success and good mid-term performance regarding prevention of stroke and bleeding.

Left Atrial Appendage Occlusion: The Current Device Landscape and Future Perspectives.

Since the first percutaneous left atrial appendage occlusion (LAAO), many studies have shown the safety and efficacy of this technique to prevent embolic strokes in nonvavular atrial fibrillation. The design, characteristics, and clinical data of the most frequently used devices for LAAO are reviewed, including the Amplatzer cardiac plug and Amulet (Abbott Vascular), the Watchman (Boston Scientific), and the LARIAT device (SentreHEART). Similarly, newer closer devices, such as Ultraseal (Cardia), LAmbre (Lifetech), and Coherex WaveCrest (Johnson & Johnson), are also discussed. Finally, new technologies still in the stage of preclinical study or in the initial clinical experience are also reviewed.

Is the new Occlutech duct occluder an appropriate device for transcatheter closure of patent ductus arteriosus?

AIM: To describe our initial experience with the Occlutech Duct Occluder (ODO) for percutaneous closure of patent ductus arteriosus (PDA). METHODS: Retrospective review of patients undergoing transcatheter PDA closure with the ODO in 2 academic centers. RESULTS: From April 2013 to September 2017, 42 patients underwent PDA closure. Median age at implantation was 34 months (range 4 months-68 years) and median weight was 12 kg (range 4.1-57 kg). Ducts were Krichenko type A duct (n = 34), type E (n = 6), and type C (n = 2). The mean duct diameter was 3.76 mm (range 1.69 to 9.95 mm, median 3.1 mm). Implantation succeeded in all. There was neither device embolization nor hemolysis. At device release, immediate angiogram showed a small residual shunt in 54.7%. During follow-up, Doppler echocardiography demonstrated 71% of full occlusion at day one, rising to 95% at one month and 100% at one year and half after implantation. The mean maximal systolic pressure gradient in left pulmonary artery was 4.2 ±â€¯4.3 mm and across the distal aortic arch 5.4 ±â€¯4.7 mm Hg. No patient had any significant stenosis with clinical relevance. CONCLUSIONS: ODO is safe and effective in transcatheter closure of PDA including relatively large sized ducts. The results are satisfactory with a high level of full occlusion and a low rate of complications. Further evaluation with larger studies and longer follow-up will be required to confirm these preliminary good results.

Patent Ductus Arteriosus closure in preterms less than 2kg: Surgery versus transcatheter.

BACKGROUND: As new devices come into the market, percutaneous techniques improve and interventionalists become more experienced; percutaneous closure gets more common in preterms. In this study we aimed to compare efficacy and safety of Patent Ductus Arteriosus closure surgically versus transcatheter method in preterms <2kg. Best of our knowledge this study is the first one that compares outcomes of surgery and percutaneous Patent Ductus Arteriosus closure in preterms. METHODS & RESULTS: Between the dates July 1997 to October 2014 in our center Patent Ductus Arteriosus of 26 patients <2kg were closed percutaneously (Group A) and 31 less than 2kg operated (Group B). Weight of patients in percutaneous Patent Ductus Arteriosus closure group was significantly more than the surgery group. Mean gestational age of the patients in Group A was 30±1.8weeks, in group B was 28.6±3.5weeks. In group A; all cases were closed successfully except 4 cases: device embolization in 2, cardiac tamponade and iatrogenic aortic coarctation were seen. Pneumomediastinum and chylothorax were the major complications of the surgery group. There was no statistically significance between complication and success rates between two groups. CONCLUSION: Percutaneous Patent Ductus Arteriosus closure is the candidate for taking the place of surgery in preterms. However, it is not applied routinely; can only be done in fully equipped large centers by experienced interventionalists.

Occlutech percutaneous patent foramen ovale closure: Safety and efficacy registry (OPPOSE).

INTRODUCTION: Safety and efficacy data on patent foramen ovale (PFO) closure with the Occlutech Figulla Flex II device are lacking. We undertook a fully monitored prospective Registry on PFO closure using this device. METHODS: 100 patients undergoing PFO closure were enrolled into the OPPOSE Registry at 6 UK centres. The primary endpoint was PFO closure (grade 0 or 1 shunt) at 6-month BCTTE assessed by Corelab. Secondary endpoints included implantation success, complications, and atrial fibrillation during follow-up. RESULTS: 100 patients aged 43.8±11.5years, 53% male, were recruited. Indications for PFO closure included stroke (56%), TIA (29%) systemic embolism (4%) and MI (3%). Closure was undertaken under GA (44%) or LA (56%), with TOE (45%), ICE (31%), no imaging (20%) or TTE (3%). Balloon sizing was used in 98% of cases and showed a tunnel length of 7.3±3.6mm, primum-secundum separation of 7.0±2.9mm and basal inlet width of 8.5±3.5mm. Implantation was successful in all cases using 18mm (9%), 25mm (80%), 30mm (10%) and 35mm (1%) devices. 5 patients were lost to follow-up. 92 patients underwent six-month BCTTE. The primary endpoint of PFO closure (grade 0 or 1 shunt) at six months was 79.3%. One patient developed major bleeding (BARC 3b), one patient required vascular surgery, and in one patient device embolization was noted at six months and a larger device implanted. There was one case of new atrial fibrillation. CONCLUSIONS: This first prospective monitored data for the Occlutech Figulla Flex II device demonstrates good safety and efficacy data at implant and six-month follow-up.

Clinical benefits, echocardiographic and MRI assessment after pulmonary sequestration treatment.

BACKGROUND: This study aimed to explore systematically procedural results, clinical benefits with echocardiographic and chest-MRI assessment of pulmonary sequestration percutaneous treatment. METHODS: 13 consecutive infants and children with diagnosis of isolated pulmonary sequestration (PS) had percutaneous closure of the aberrant artery supplying pulmonary sequestration between 2010 and 2015. By protocol, echocardiographic and chest-MRI assessment was performed before and respectively at 6-12months and 1year with the aim to study the effects of embolization on heart volume overload and regression of pulmonary sequestration. RESULTS: Median age at diagnosis was 1year (95%CI 0-2.6); median age at treatment was 1.3years (95%CI1.01-2.85). In all pts the PS was confirmed by chest-MRI. Procedural success was 100%. After treatment, pts experiencing previously respiratory symptoms/infections remained asymptomatic at 2.9year follow-up. In pts with significant shunt due to PS, treatment resulted in amelioration in left or right cardiac chamber enlargement at 6 and 12month follow-up. At distance from PS closure (median 14months), chest-MRI confirmed the closure of the aberrant artery and PS regression in 12 patients. In one case, despite the acute procedural success and the supplying artery remained closed, MRI detected residual PS revascularization. CONCLUSIONS: Percutaneous PS closure in infants and children is safe and provide regression in respiratory symptoms and heart chamber dilatation if significant shunt is present. MRI is able to define aberrant artery course and PS parenchima, and might represent a valid instrument to study residual PS parenchima during growth.

Patients with intracranial bleeding and atrial fibrillation treated with left atrial appendage occlusion: Results from the Amplatzer Cardiac Plug registry.

BACKGROUND: In patients with non-valvular atrial fibrillation (NVAF), intracranial bleeding (ICB) constitutes a very challenging situation in which the rate of both ischemic and hemorrhagic events is increased. In these patients, left atrial appendage occlusion (LAAO) might represent a very valid alternative. OBJECTIVES: To investigate the procedural safety and long-term outcome of patients undergoing LAAO therapy due to previous ICB. METHODS: Data from the Amplatzer Cardiac Plug multicenter registry on 1047 consecutive patients were analyzed. Patients with previous ICB as indication for LAAO were compared to patients with other indications. RESULTS: A total of 198 patients (18.9%) with previous ICB were identified. The CHA2DS2-VASc score was similar (4.5±1.5 vs. 4.4±1.6, p=0.687) and the HAS-BLED score was higher in patients with previous ICB compared to those without (3.5±1.1 vs. 3.1±1.2, p<0.001). No significant differences in peri-procedural major adverse events were observed (2.5 vs 5.4%, p=0.1). Patients with previous ICB were more frequently on single acetylsalicylic acid therapy after LAAO (42.4% vs. 28.3%; p<0.001). With an average follow-up of 1.3years, the observed annual stroke/TIA rate (procedure and follow-up) for patients with previous ICB was 1.4% (75% relative risk reduction). The observed annual major bleeding rate (procedure and follow-up) for patients with previous ICB was 0.7% (89% relative risk reduction). CONCLUSIONS: In patients with NVAF and previous ICB, LAAO seemed to be a safe procedure and was associated with a significant reduction in stroke/TIA and a remarkably low frequency of major bleeding during follow-up.

Percutaneous closure of patent foramen ovale: safe and effective but underutilized.

With three recently published randomized trials on patent foramen ovale (PFO) closure, the concept of PFO closure to reduce recurrent strokes has been proven; however, PFO closure is currently only considered for secondary prevention. Given the potential devastating consequences of a PFO-related event, we advocate screening for and closure of a PFO for primary prevention in high-risk populations. Such populations include patients who are suffering from a disease that is associated with PFO (e.g., migraine) or patients with high-risk hobbies/professions (e.g., weight-lifters, frequent-flyers, and deep sea divers). Looking at young people with a remaining average life expectancy of 50 years, we have to close 2.4 PFOs to prevent one stroke. This should support a more proactive attitude toward PFO screening and closure.

Left atrial appendage occlusion: initial experience with the Amplatzer™ Amulet™.

BACKGROUND: The Amplatzer™ Amulet™ (Amulet) is the evolution of the Amplatzer™ Cardiac Plug, a dedicated device for percutaneous left atrial appendage (LAA) occlusion. The new device has been designed to facilitate the implantation process, improve the sealing performance and further reduce the risk of complications. The objective of the study was to describe the initial experience with the Amplatzer Amulet for percutaneous LAA occlusion. METHODS: This was a prospective single-center study of patients undergoing percutaneous LAA occlusion. The indication for LAA closure was a formal contraindication for oral anticoagulation or previous history of stroke due to INR lability. All procedures were done under general anesthesia and transesophageal echocardiography (TEE) guidance. Transthoracic echocardiography was performed 24h after the procedure in order to rule out procedural complications before discharge. Further follow-up was done with a clinical visit and TEE at 1-3 months. RESULTS: Between July-2012 and June-2013, 25 patients with a mean CHA2DS2-VASC of 4.3 ± 1.7 underwent LAA occlusion with the Amplatzer Amulet. The device was successfully implanted in 24 patients (96%) without any procedural stroke, pericardial effusion or device embolization. None of the patients presented any clinical event at follow-up. Follow-up TEE showed complete LAA sealing in all patients with no residual leaks >3mm and no device embolization. One patient (4.1%) presented a device thrombosis at follow-up without clinical expression. CONCLUSION: In this initial series of patients, the Amulet showed a remarkable acute and short-term performance in terms of feasibility and safety as depicted by the high successful implantation rate and the low incidence of complications.

Left atrial appendage closure devices. Their role in 2013.

Stroke prevention is the major goal in treating patients with atrial fibrillation. Warfarin therapy, if used appropriately, is highly effective in preventing thromboembolic events, but is simultaneously burdened by a narrow therapeutic window, multiple food and drug interactions, and a substantial bleeding risk. New pharmacological agents show only a modest reduction of bleeding complications compared to warfarin. Percutaneous device left atrial appendage (LAA) closure has now been technologically advanced as an additional and potential alternative to pharmacotherapy in patients with AF. Promising randomized data are obtainable with the WATCHMAN® device, while several other devices are in various stages of clinical and preclinical development. In this article we review the current knowledge and status of this technique.

Percutaneous mitral and aortic paravalvular leak repair: indications, current application, and future directions.

Paravalvular regurgitation (PVR) is a symptomatic or asymptomatic complication after surgical valve replacement. It may be related to calcification, infection or tissue friability and occurs in 5 % to 17 % of surgical implanted heart valves. Reoperation is associated with a higher morbidity and mortality than the index procedure. Percutaneous closure of PVR can be an effective and lower risk alternative to reoperation. However, feasibility for percutaneous closure has to be assessed by defining the shape, size and location of the defect. Echocardiography with three-dimensional defect reconstruction is a cornerstone for guiding percutaneous PVR closure. Access for aortic PVR is usually retrograde via the femoral artery and access to mitral PVR either retrograde from the aorta, transvenous-transseptal or transapical. Meticulous planning and prudent procedural execution by experienced operators ensuring no impingement of the prosthetic leaflets leads to a high success rate of percutaneous PVR repair.

Update on the Amplatzer duct occluder: a 10-year experience in Asia.

Few data exist regarding the efficacy and safety of the Amplatzer ductal occluder (ADO) type 1 device in the Asian region. This retrospective study, conducted between August 2001 and April 2011, attempted device placement for 231 patients (165 females and 66 males) with a median age of 7.4 years (range, 3 months to 64 years) and an average weight of 19.4 kg (range, 4.1-81.0 kg). Among the patients in this study, 66 (28.6%) had pulmonary hypertension, ten (4.3%) had trisomy 21, and eight (3.5%) had other congenital cardiac anomalies. The mean narrowest patent ductus arteriosus (PDA) diameter was 4.2 mm (range, 1.3-10 mm), and the ampulla size was 9.6 mm (range, 4-20 mm). Successful implantation was achieved for 229 patients (99.1%). Complete angiographic occlusion was achieved for 201 patients (87.8%) at the end the procedure. Follow-up data were available for 129 patients (66%). At the follow-up assessment, complete echocardiographic occlusion was seen in 128 patients (99.2%) after 1 month and in 100% of the patients after 6 months. The significant morbidities involved one device embolization and one dislodgment, for which surgical retrieval was performed. No mortalities occurred during the study period, and no late clinical adverse events occurred during the follow-up period. Occlusion of the PDA using ADO is safe, effective, and applicable for a wide range of PDA sizes including large PDAs in small symptomatic infants and in adults. Good outcomes can be attributed to experience of the operators, proper patient selection, and appropriate device size selection.

New directions in device therapies among children and adults with congenital heart.

Innovative, nonthoracotomy, catheter-delivered therapies have redefined the approach to and treatment of congenital heart defects. Starting in the 1960s with the creation of an opening in the atrial septum to permit effective blood mixing and improve oxygen saturation in cyanotic infants, interventional cardiac procedures continue to replace many of the time-honored surgeries that were the mainstay of repair or correction for infants and children with heart defects. Now as those children reach adulthood and still require modifications of their defects, catheter-based interventions are becoming more important. This article examines some of the more recent applications of device therapy currently available to patients with congenital heart, including heart failure, septal defects, vascular problems and heart valves. Device use in deference to surgery, risks and benefits as well as complications associated with such catheter-delivered therapies are discussed.

Advances in paediatric interventional cardiology since 2000.

Interventional paediatric and congenital cardiology is expanding at a rapid pace. Validated techniques (such as aortic or pulmonary valve dilatations and occlusion of persistent ductus arteriosus and atrial septal defects) are improving thanks to the use of smaller introducers and sheaths, low-profile balloons and novel devices. Moreover, catheter-based interventions have emerged as an attractive alternative to surgery in other fields: pulmonary valve replacement, balloon and stent implantation for native and recurrent coarctation, and percutaneous closure of ventricular septal defects. On the other hand, percutaneous interventions in the paediatric population may be limited by patient size or the anatomy of the defect. Hybrid approaches involving both cardiac interventionists and surgeons are being developed to overcome these limitations. Based on a better understanding of cardiac development, fetal cardiac interventions are being attempted in order to alter the history of severe obstructive lesions. Finally, some interventional procedures still carry a low success rate-for example, pulmonary vein stenosis, even with the use of conventional stents. Biodegradable stents and devices are being developed and may find an application in this setting as well as in others. The purpose of this review is to highlight the advances in paediatric interventional cardiology since the beginning of the third millennium.