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Ziyad M Hijazi - One of the best experts on this subject based on the ideXlab platform.
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multiple amplatzer septal occluder Devices for multiple atrial communications immediate and long term follow up results
Catheterization and Cardiovascular Interventions, 2007Co-Authors: Sawsan Awad, Francisco Garay, Qiling Cao, Ziyad M HijaziAbstract:Objectives: We report on the feasibility, effectiveness, and long-term outcome of transcatheter closure of multiple ASD's using multiple ASO Devices. Background: Little is known about the use and long-term outcome of multiple Amplatzer Septal Occluder (ASO) Devices to close multiple atrial septal defects (ASD's). Methods: From May 1997 to June 2006, 33 patients (mean age 38.9 years and mean weight 68 kg) underwent transcatheter closure of multiple ASD's under transesophageal (TEE) or intracardiac echocardiographic (ICE) guidance. Results: Unless not available, the Device size chosen to be deployed was ±2 mm larger than the stretched diameter or no more than 30–40% larger than the ICE/TEE 2D diameter. Sixty-seven Devices were deployed in 33 patients. The mean diameters of the larger and smaller defects were 12.9 and 7.7 mm, and the corresponding mean balloon stretched diameters were 19.2 and 12.0 mm, respectively. The mean larger and smaller Device diameters were 19.0 and 13.4 mm, respectively. The mean QP: Qs ratio was 1.8:1. The mean fluoroscopy time, and procedure time were 16.4 and 81.6 min respectively. Immediately after the procedure 15 patients had complete closure, 8 had trivial shunt, 9 had small shunt and one had large shunt. Complications included a Device Embolization within 24 hr and left atrial-aortic wall erosion and pericardial effusion at 2 years. The mean follow-up interval was 34.8 + 25.7 months. Conclusions: Device closure of multiple ASD's using multiple ASO's is safe and effective. Continued follow-up is important to assess the long-term outcome. © 2007 Wiley-Liss, Inc.
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evaluation of the amplatzer vascular plug for Embolization of peripheral vascular malformations associated with congenital heart disease
Catheterization and Cardiovascular Interventions, 2006Co-Authors: Sharon L Hill, William E. Hellenbrand, Ziyad M Hijazi, John P CheathamAbstract:Objective: The purpose of this study is to evaluate the recently FDA-approved AMPLATZER® Vascular Plug in the Embolization of vascular lesions associated with congenital heart disease (CHD). Background: Fistulas and arteriovenous malformations have been occluded using various Devices. The AMPLATZER Vascular Plug is a self-expandable, cylindrical Device, used for Embolization in the peripheral vasculature. Methods: A total of 84 vessels in 52 patients with CHD from 11 centers were occluded with 89 AMPLATZER Vascular Plugs, delivered through a coronary guide catheter in various vascular sites, including collaterals, pulmonary arterio-venous and coronary artery fistulas, transhepatic tracts, central shunts, patent ductus arteriosus (PDA), and excluded hepatic vein. Complete vessel occlusion was demonstrated within 10 min in 94% of patients. Results: There was no Device Embolization, vascular disruption, or procedure-related complication. One vascular plug implanted in a large type C PDA required surgical removal followed by PDA ligation, after 5 weeks from successful implant because of significant residual flow through the Device. Conclusions: The AMPLATZER Vascular Plug is an effective transcatheter occlusion Device in the Embolization of a wide variety of vascular lesions associated with CHD. Based on our early experience, caution should be used when considering the Vascular Plug as a closure Device for large PDA. © 2005 Wiley-Liss, Inc.
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transcatheter closure of large secundum atrial septal defects using the 40 mm amplatzer septal occluder results of an international registry
Catheterization and Cardiovascular Interventions, 2005Co-Authors: Keila Lopez, Qiling Cao, Bharat Dalvi, David T Balzer, John L Bass, Tarek Momenah, Ziyad M HijaziAbstract:Little is known about the efficacy and safety of the 40 mm Amplatzer septal occluder (ASO). Thirty-three patients (22 female, 11 male) with a large secundum atrial septal defect (ASD) underwent attempted Device closure using the 40 mm ASO at a median age of 40 years (range, 14-81 years) and median weight of 65 kg (range, 48-98 kg). The median size of the ASD measured on 2D transesophageal echocardiography (27 patients) or intracardiac echocardiography (6 patients) was 30.5 mm (range, 24-39 mm) and the median balloon-stretched diameter was 37.7 mm (range, 32-43.7 mm). The median Qp:Qs ratio was 3.2:1 (range, 1.4-6.2). The attempt was unsuccessful in five patients; two had Device Embolization and one had left atrial wall perforation due to the sheath; all three required emergent surgery. The attempt was successful in the 28 remaining patients, resulting in complete immediate closure in 14 and a trivial residual shunt in 14. Fluoroscopy time ranged from 8.6 to 37.8 min (median, 12.2 min). At 24-hr follow-up, 2D transthoracic echocardiography with color flow Doppler revealed complete closure in 23 patients, and 5 had a trivial residual shunt. There were no complications encountered in patients who received the Device. On follow-up, all patients are doing well. We conclude that the 40 mm ASO is safe and effective in most patients with a large ASD up to a diameter of 39 mm. However, the use of this Device requires careful attention as the procedure may be unsuccessful or the Device may embolize.
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Device closure of muscular ventricular septal defects using the amplatzer muscular ventricular septal defect occluder immediate and mid term results of a u s registry
Journal of the American College of Cardiology, 2004Co-Authors: Ralf J Holzer, Ziyad M Hijazi, David T Balzer, Ken Lock, Amplatzer Muscular Ventricular Septal Defect InvestigatorsAbstract:Abstract Objectives We sought to report the results of a U.S. registry of Device closure of congenital muscular ventricular septal defects (VSDs) using the new Amplatzer mVSD occluder (AGA Medical Corp., Golden Valley, Minnesota). Background Muscular VSDs pose a significant surgical challenge with increased morbidity and mortality. Methods Data were prospectively collected from 83 procedures involving 75 patients who underwent an attempt of percutaneous (70 [93.3%] of 75) and/or perventricular (surgical) (6 [8.0%] of 75) Device closure of hemodynamically significant muscular VSDs. The patients' median age was 1.4 years (range 0.1 to 54.1 years). Outcome parameters were procedural success, evidence of residual shunts on echocardiography, and occurrence of procedure-related complications. The median follow-up was 211 days (range 1 to 859 days). Results The median size of the primary VSD was 7 mm (range 3 to 16 mm) and in 34 of 78 (43.6%) procedures, patients had multiple VSDs (range 2 to 7). The Device was implanted successfully in 72 of 83 (86.7%) procedures. In 17 of 83 (20.5%) procedures, multiple Devices were implanted (range 2 to 3). Procedure-related major complications occurred in 8 of 75 (10.7%) patients. Device Embolization occurred in two patients and cardiac perforation in one patient. There were two (2.7%) procedure-related deaths. The 24-h postprocedural complete closure rate was 47.2% (34 of 72 patients), increasing to 69.6% (32 of 46 patients) at 6 months and 92.3% (24 of 26 patients) at 12 months. Six patients underwent successful closure using the perventricular surgical (beating heart) approach, with complete closure at day 1 in three patients and trivial/small residual shunts in the remainder of the patients. Conclusions The Amplatzer mVSD Device (AGA Medical Corp.) offers excellent closure rates and low mortality when used to close congenital muscular VSDs. The Device appears to be safe and effective.
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transcatheter left atrial appendage occlusion with amplatzer Devices to obviate anticoagulation in patients with atrial fibrillation
Catheterization and Cardiovascular Interventions, 2003Co-Authors: Bernhard Meier, David Keane, Carlos E Ruiz, Martin Rotter, Igor F. Palacios, Stephan Windecker, Ziyad M HijaziAbstract:It is assumed that over 90% of clinically apparent embolisms in atrial fibrillation originate from the left atrial appendage. Recently, a percutaneous method (PLAATO technique) to occlude the left atrial appendage to the end of preventing thromboembolic complications of atrial fibrillation has been introduced into clinical practice. This technique is quite intricate and requires general anesthesia. The Amplatzer atrial septal occluder lends itself for a more simple approach to this intervention. The first 16 patients treated at four centers are described. Their age varied from 58 to 83 years. All suffered from atrial fibrillation but eight of them were in sinus rhythm at the time of implantation. All but two procedures were done under local anesthesia of the groin only. There was one technical failure (Device Embolization) requiring surgery. All other patients left the hospital a day after the procedure without complications. There were no problems or embolic events during an overall follow-up of 5 patient-years and all left atrial appendages were completely occluded without evidence of thrombosis at the atrial side of the Device at the latest follow-up echocardiography. With the Amplatzer technique, the left atrial appendage can be percutaneously occluded with a venous puncture under local anesthesia, without echocardiographic guidance, and at a reasonable risk. It remains to be evaluated in larger series or randomized trials how the simpler Amplatzer technique compares with the complex PLAATO technique, and whether left atrial appendage closure is competitive with oral anticoagulation with warfarin or the novel ximelagatran to prevent thromboembolism in atrial fibrillation. Catheter Cardiovasc Interv 2003;60:417–422. © 2003 Wiley-Liss, Inc.
Apostolos Tzikas - One of the best experts on this subject based on the ideXlab platform.
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incidence and clinical impact of Device associated thrombus and peri Device leak following left atrial appendage closure with the amplatzer cardiac plug
Jacc-cardiovascular Interventions, 2017Co-Authors: Jacqueline Saw, Joelle Kefer, Apostolos Tzikas, Adel Aminian, Heyder Omran, Samera Shakir, Sameer Gafoor, Jens Erik Nielsenkudsk, Sergio Berti, Gennaro SantoroAbstract:Abstract Objectives Routine Device surveillance after successful left atrial appendage closure is recommended to evaluate for intermediate to late complications. The aim of this study was to assess the incidence and clinical impact of these complications on cardiovascular events. Methods Centers participating in the Amplatzer Cardiac Plug multicenter study were requested to submit their post-procedural transesophageal echocardiograms for independent adjudication. Thirteen of 22 centers contributed all their post-procedural echocardiograms, which included 344 from 605 consecutive patients. These images were submitted to a core laboratory and reviewed by 2 independent experts for peri-Device leak, Device-associated thrombus, Device Embolization, Device migration, left atrial appendage thrombus, and left atrial thrombus. Clinical events were prospectively collected by each center. Results Of the 344 transesophageal echocardiograms, 339 were deemed analyzable. Patients’ mean age was 74.4 ± 7.5 years, and 67.3% were men. The mean CHADS2 score was 2.7 ± 1.3, the mean CHA2DS2-VASc score was 4.3 ± 1.5, and the mean HAS-BLED score was 3.0 ± 1.2. Amplatzer Cardiac Plug implantation was successful in all patients. Periprocedural major adverse events occurred in 2.4%. Median clinical follow-up duration was 355 days (range 179 to 622 days). Follow-up transesophageal echocardiography was performed after a median of 134 days (range 88 to 227 days). Device-associated thrombus was observed in 3.2% and peri-Device leak in 12.5% (5.5% minimal, 5.8% mild, 0.6% moderate, 0.6% severe). Neither Device-associated thrombus nor peri-Device leak was associated with an increased risk for cardiovascular events. Independent predictors of Device-associated thrombus were smoking (odds ratio: 5.79; p = 0.017) and female sex (odds ratio: 4.22; p = 0.027). Conclusions Following successful left atrial appendage closure with the Amplatzer Cardiac Plug, the presence of peri-Device leak was relatively low, and Device-associated thrombus was infrequent. Neither was associated with increased risk for thromboembolism.
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incidence and clinical impact of Device associated thrombus and peri Device leak following left atrial appendage closure with the amplatzer cardiac plug
Jacc-cardiovascular Interventions, 2017Co-Authors: Apostolos Tzikas, Joelle Kefer, Adel Aminian, Heyder Omran, Samera Shakir, Sameer Gafoor, Jens Erik Nielsenkudsk, Sergio Berti, Gennaro Santoro, Fabian NietlispachAbstract:Abstract Objectives Routine Device surveillance after successful left atrial appendage closure is recommended to evaluate for intermediate to late complications. The aim of this study was to assess the incidence and clinical impact of these complications on cardiovascular events. Methods Centers participating in the Amplatzer Cardiac Plug multicenter study were requested to submit their post-procedural transesophageal echocardiograms for independent adjudication. Thirteen of 22 centers contributed all their post-procedural echocardiograms, which included 344 from 605 consecutive patients. These images were submitted to a core laboratory and reviewed by 2 independent experts for peri-Device leak, Device-associated thrombus, Device Embolization, Device migration, left atrial appendage thrombus, and left atrial thrombus. Clinical events were prospectively collected by each center. Results Of the 344 transesophageal echocardiograms, 339 were deemed analyzable. Patients’ mean age was 74.4 ± 7.5 years, and 67.3% were men. The mean CHADS2 score was 2.7 ± 1.3, the mean CHA2DS2-VASc score was 4.3 ± 1.5, and the mean HAS-BLED score was 3.0 ± 1.2. Amplatzer Cardiac Plug implantation was successful in all patients. Periprocedural major adverse events occurred in 2.4%. Median clinical follow-up duration was 355 days (range 179 to 622 days). Follow-up transesophageal echocardiography was performed after a median of 134 days (range 88 to 227 days). Device-associated thrombus was observed in 3.2% and peri-Device leak in 12.5% (5.5% minimal, 5.8% mild, 0.6% moderate, 0.6% severe). Neither Device-associated thrombus nor peri-Device leak was associated with an increased risk for cardiovascular events. Independent predictors of Device-associated thrombus were smoking (odds ratio: 5.79; p = 0.017) and female sex (odds ratio: 4.22; p = 0.027). Conclusions Following successful left atrial appendage closure with the Amplatzer Cardiac Plug, the presence of peri-Device leak was relatively low, and Device-associated thrombus was infrequent. Neither was associated with increased risk for thromboembolism.
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Embolization of left atrial appendage closure Devices a systematic review of cases reported with the watchman Device and the amplatzer cardiac plug
Catheterization and Cardiovascular Interventions, 2015Co-Authors: Adel Aminian, Jacques Lalmand, Edouard Benit, Apostolos Tzikas, Werner Budts, Joelle KeferAbstract:Objectives We sought to provide a systematic review of reported cases of LAA closure Device Embolization by focusing on the two most commonly implanted Devices: the Watchman (WM) Device and the Amplatzer Cardiac Plug (ACP). Methods A comprehensive search of the Pubmed database was conducted until October 1, 2014. Studies were included if they described at least 1 case of Embolization of the WM and/or the ACP. Results A total of 20 studies reporting 31 cases of Device Embolization were identified, including 13 cases with WM and 18 cases. The timing of Embolization was described in 29 cases and was categorized as acute in 20 cases (65%) and late in 9 cases (30%). The anatomical location of embolized Devices was reported in 21 cases: into the aorta in 9 cases, into the left ventricle (LV) in 9 cases and into the left atrial cavity in 3 cases. As compared to Embolization into the aorta or the left atrial cavity, Device Embolization into the LV was associated with a higher rate of surgical retrieval (8/9 vs 2/12; 88% vs 17%, P = 0.0019). Major adverse events related to Device Embolization occurred in three patients (9.6%). Conclusions LAA closure Device Embolization occurs mainly in the periprocedural period but late Embolizations are not uncommon. Although Embolization into the aorta or the left atrium can be successfully managed by percutaneous techniques in most cases, Device Embolization into the LV is associated with a higher rate of surgical retrieval, increasing thereby procedure-related morbidity. © 2015 Wiley Periodicals, Inc.
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left atrial appendage occlusion initial experience with the amplatzer amulet
International Journal of Cardiology, 2014Co-Authors: Apostolos Tzikas, Xavier Freixa, Ali Abualsaud, Jason Chan, Mohamed Nosair, Patrick Garceau, Arsene Basmadjian, Reda IbrahimAbstract:Abstract 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 1–3months. Results Between July-2012 and June-2013, 25 patients with a mean CHA 2 DS 2 -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.
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the chicken wing morphology an anatomical challenge for left atrial appendage occlusion
Journal of Interventional Cardiology, 2013Co-Authors: M Xavier D Freixa, Apostolos Tzikas, M Arsene D Basmadjian, M Patrick D Garceau, M Reda D IbrahimAbstract:Objectives To describe the particular assessment and closure strategy that was followed in patients with left atrial appendages (LAA) with an early and severe bend. Background The presence of a chicken-wing morphology with an early and severe bend constitutes one of the most difficult anatomical settings for transcatheter LAA occlusion. Methods Between November 2009 and December 2012, patients who presented chicken-wing LAA with an early (<20 mm from the ostium) and severe bend (<180°) were identified and included in the analysis. A particular implanting strategy consisting of deploying the distal lobe of the Device inside the chicken-wing bend was used in all cases. Results Among 42 patients who underwent LAA occlusion during the study period, 5 (12%) presented the pre-specified anatomy. Following the mentioned implanting strategy, all patients underwent successful LAA occlusion using the Amplatzer Cardiac Plug (n = 2) and the Amplatzer Amulet (n = 3). Successful occlusion was achieved in all patients. None of them presented any procedural complication. Follow-up transesophageal echocardiography at 3 months showed successful LAA sealing in all patients and no Device Embolization or thrombosis. Conclusions According to our results, the pre-specified closing implantation technique for chicken-wing LAAs with an early and severe bend might be a valid strategy for this challenging anatomical setting. Further cases will be necessary to confirm the results. (J Interven Cardiol 2013;26:509-514)
Gennaro Santoro - One of the best experts on this subject based on the ideXlab platform.
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intracardiac versus transesophageal echocardiographic guidance for left atrial appendage occlusion the laao italian multicenter registry
Jacc-cardiovascular Interventions, 2018Co-Authors: Sergio Berti, Gennaro Santoro, Luigi Emilio Pastormerlo, Elvis Brscic, Matteo Montorfano, Luigi Vignali, Paolo Danna, Claudio Tondo, Marco Rezzaghi, Gianpiero DamicoAbstract:Abstract Objectives This study sought to evaluate the feasibility, safety, and efficacy of intracardiac echocardiography (ICE)–guided versus transesophageal echocardiography (TEE)–guided left atrial appendage occlusion (LAAO) by the use of Amplatzer Cardiac Plug or Amulet Devices included in a large Italian registry. Background TEE is widely used for LAAO procedure guidance. ICE may be a potential alternative imaging modality in LAAO. Methods Data from 604 LAAO procedures performed in 16 Italian centers were reviewed. ICE-guided LAAO was performed in 187 patients, whereas TEE was used in 417 patients. Procedural success was defined as LAAO without occurrence of pericardial tamponade, stroke, systemic embolism with end organ damage, major bleeding, and Device Embolization. Stroke, transient ischemic attack, major bleeding, overall and cardiovascular death were analyzed. Results CHA 2 DS 2 -VASc (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, prior stroke or transient ischemic attack or thromboembolism, vascular disease, age 65 to 74 years, sex category) and HAS-BLED (hypertension, abnormal renal and liver function, stroke, bleeding, labile international normalized ratio, elderly, drugs or alcohol) scores were similar between the ICE and TEE groups. TEE implied lower procedural (delta 12 min) and fluoroscopy time (delta 5 min) when compared with ICE. Procedural success was similarly high (≥94%) between the TEE and ICE groups with a complication rate of 6.5% for TEE versus 4.2% for ICE (odds ratio: 1.468; 95% confidence interval: 0.681 to 3.166; p = 0.327). At median follow-up of 451 days (interquartile range: 162 to 899 days), the rate of cerebral ischemic events was similar between TEE-guided and ICE-guided procedures. Conclusions ICE-guided LAAO by means of Amplatzer Devices may represent a second alternative imaging modality after an appropriate learning curve and bearing in mind that pre-procedural computed tomography imaging is mandatory. When comparing ICE with TEE, TEE remains the gold standard.
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incidence and clinical impact of Device associated thrombus and peri Device leak following left atrial appendage closure with the amplatzer cardiac plug
Jacc-cardiovascular Interventions, 2017Co-Authors: Jacqueline Saw, Joelle Kefer, Apostolos Tzikas, Adel Aminian, Heyder Omran, Samera Shakir, Sameer Gafoor, Jens Erik Nielsenkudsk, Sergio Berti, Gennaro SantoroAbstract:Abstract Objectives Routine Device surveillance after successful left atrial appendage closure is recommended to evaluate for intermediate to late complications. The aim of this study was to assess the incidence and clinical impact of these complications on cardiovascular events. Methods Centers participating in the Amplatzer Cardiac Plug multicenter study were requested to submit their post-procedural transesophageal echocardiograms for independent adjudication. Thirteen of 22 centers contributed all their post-procedural echocardiograms, which included 344 from 605 consecutive patients. These images were submitted to a core laboratory and reviewed by 2 independent experts for peri-Device leak, Device-associated thrombus, Device Embolization, Device migration, left atrial appendage thrombus, and left atrial thrombus. Clinical events were prospectively collected by each center. Results Of the 344 transesophageal echocardiograms, 339 were deemed analyzable. Patients’ mean age was 74.4 ± 7.5 years, and 67.3% were men. The mean CHADS2 score was 2.7 ± 1.3, the mean CHA2DS2-VASc score was 4.3 ± 1.5, and the mean HAS-BLED score was 3.0 ± 1.2. Amplatzer Cardiac Plug implantation was successful in all patients. Periprocedural major adverse events occurred in 2.4%. Median clinical follow-up duration was 355 days (range 179 to 622 days). Follow-up transesophageal echocardiography was performed after a median of 134 days (range 88 to 227 days). Device-associated thrombus was observed in 3.2% and peri-Device leak in 12.5% (5.5% minimal, 5.8% mild, 0.6% moderate, 0.6% severe). Neither Device-associated thrombus nor peri-Device leak was associated with an increased risk for cardiovascular events. Independent predictors of Device-associated thrombus were smoking (odds ratio: 5.79; p = 0.017) and female sex (odds ratio: 4.22; p = 0.027). Conclusions Following successful left atrial appendage closure with the Amplatzer Cardiac Plug, the presence of peri-Device leak was relatively low, and Device-associated thrombus was infrequent. Neither was associated with increased risk for thromboembolism.
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incidence and clinical impact of Device associated thrombus and peri Device leak following left atrial appendage closure with the amplatzer cardiac plug
Jacc-cardiovascular Interventions, 2017Co-Authors: Apostolos Tzikas, Joelle Kefer, Adel Aminian, Heyder Omran, Samera Shakir, Sameer Gafoor, Jens Erik Nielsenkudsk, Sergio Berti, Gennaro Santoro, Fabian NietlispachAbstract:Abstract Objectives Routine Device surveillance after successful left atrial appendage closure is recommended to evaluate for intermediate to late complications. The aim of this study was to assess the incidence and clinical impact of these complications on cardiovascular events. Methods Centers participating in the Amplatzer Cardiac Plug multicenter study were requested to submit their post-procedural transesophageal echocardiograms for independent adjudication. Thirteen of 22 centers contributed all their post-procedural echocardiograms, which included 344 from 605 consecutive patients. These images were submitted to a core laboratory and reviewed by 2 independent experts for peri-Device leak, Device-associated thrombus, Device Embolization, Device migration, left atrial appendage thrombus, and left atrial thrombus. Clinical events were prospectively collected by each center. Results Of the 344 transesophageal echocardiograms, 339 were deemed analyzable. Patients’ mean age was 74.4 ± 7.5 years, and 67.3% were men. The mean CHADS2 score was 2.7 ± 1.3, the mean CHA2DS2-VASc score was 4.3 ± 1.5, and the mean HAS-BLED score was 3.0 ± 1.2. Amplatzer Cardiac Plug implantation was successful in all patients. Periprocedural major adverse events occurred in 2.4%. Median clinical follow-up duration was 355 days (range 179 to 622 days). Follow-up transesophageal echocardiography was performed after a median of 134 days (range 88 to 227 days). Device-associated thrombus was observed in 3.2% and peri-Device leak in 12.5% (5.5% minimal, 5.8% mild, 0.6% moderate, 0.6% severe). Neither Device-associated thrombus nor peri-Device leak was associated with an increased risk for cardiovascular events. Independent predictors of Device-associated thrombus were smoking (odds ratio: 5.79; p = 0.017) and female sex (odds ratio: 4.22; p = 0.027). Conclusions Following successful left atrial appendage closure with the Amplatzer Cardiac Plug, the presence of peri-Device leak was relatively low, and Device-associated thrombus was infrequent. Neither was associated with increased risk for thromboembolism.
Sergio Berti - One of the best experts on this subject based on the ideXlab platform.
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intracardiac versus transesophageal echocardiographic guidance for left atrial appendage occlusion the laao italian multicenter registry
Jacc-cardiovascular Interventions, 2018Co-Authors: Sergio Berti, Gennaro Santoro, Luigi Emilio Pastormerlo, Elvis Brscic, Matteo Montorfano, Luigi Vignali, Paolo Danna, Claudio Tondo, Marco Rezzaghi, Gianpiero DamicoAbstract:Abstract Objectives This study sought to evaluate the feasibility, safety, and efficacy of intracardiac echocardiography (ICE)–guided versus transesophageal echocardiography (TEE)–guided left atrial appendage occlusion (LAAO) by the use of Amplatzer Cardiac Plug or Amulet Devices included in a large Italian registry. Background TEE is widely used for LAAO procedure guidance. ICE may be a potential alternative imaging modality in LAAO. Methods Data from 604 LAAO procedures performed in 16 Italian centers were reviewed. ICE-guided LAAO was performed in 187 patients, whereas TEE was used in 417 patients. Procedural success was defined as LAAO without occurrence of pericardial tamponade, stroke, systemic embolism with end organ damage, major bleeding, and Device Embolization. Stroke, transient ischemic attack, major bleeding, overall and cardiovascular death were analyzed. Results CHA 2 DS 2 -VASc (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, prior stroke or transient ischemic attack or thromboembolism, vascular disease, age 65 to 74 years, sex category) and HAS-BLED (hypertension, abnormal renal and liver function, stroke, bleeding, labile international normalized ratio, elderly, drugs or alcohol) scores were similar between the ICE and TEE groups. TEE implied lower procedural (delta 12 min) and fluoroscopy time (delta 5 min) when compared with ICE. Procedural success was similarly high (≥94%) between the TEE and ICE groups with a complication rate of 6.5% for TEE versus 4.2% for ICE (odds ratio: 1.468; 95% confidence interval: 0.681 to 3.166; p = 0.327). At median follow-up of 451 days (interquartile range: 162 to 899 days), the rate of cerebral ischemic events was similar between TEE-guided and ICE-guided procedures. Conclusions ICE-guided LAAO by means of Amplatzer Devices may represent a second alternative imaging modality after an appropriate learning curve and bearing in mind that pre-procedural computed tomography imaging is mandatory. When comparing ICE with TEE, TEE remains the gold standard.
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incidence and clinical impact of Device associated thrombus and peri Device leak following left atrial appendage closure with the amplatzer cardiac plug
Jacc-cardiovascular Interventions, 2017Co-Authors: Jacqueline Saw, Joelle Kefer, Apostolos Tzikas, Adel Aminian, Heyder Omran, Samera Shakir, Sameer Gafoor, Jens Erik Nielsenkudsk, Sergio Berti, Gennaro SantoroAbstract:Abstract Objectives Routine Device surveillance after successful left atrial appendage closure is recommended to evaluate for intermediate to late complications. The aim of this study was to assess the incidence and clinical impact of these complications on cardiovascular events. Methods Centers participating in the Amplatzer Cardiac Plug multicenter study were requested to submit their post-procedural transesophageal echocardiograms for independent adjudication. Thirteen of 22 centers contributed all their post-procedural echocardiograms, which included 344 from 605 consecutive patients. These images were submitted to a core laboratory and reviewed by 2 independent experts for peri-Device leak, Device-associated thrombus, Device Embolization, Device migration, left atrial appendage thrombus, and left atrial thrombus. Clinical events were prospectively collected by each center. Results Of the 344 transesophageal echocardiograms, 339 were deemed analyzable. Patients’ mean age was 74.4 ± 7.5 years, and 67.3% were men. The mean CHADS2 score was 2.7 ± 1.3, the mean CHA2DS2-VASc score was 4.3 ± 1.5, and the mean HAS-BLED score was 3.0 ± 1.2. Amplatzer Cardiac Plug implantation was successful in all patients. Periprocedural major adverse events occurred in 2.4%. Median clinical follow-up duration was 355 days (range 179 to 622 days). Follow-up transesophageal echocardiography was performed after a median of 134 days (range 88 to 227 days). Device-associated thrombus was observed in 3.2% and peri-Device leak in 12.5% (5.5% minimal, 5.8% mild, 0.6% moderate, 0.6% severe). Neither Device-associated thrombus nor peri-Device leak was associated with an increased risk for cardiovascular events. Independent predictors of Device-associated thrombus were smoking (odds ratio: 5.79; p = 0.017) and female sex (odds ratio: 4.22; p = 0.027). Conclusions Following successful left atrial appendage closure with the Amplatzer Cardiac Plug, the presence of peri-Device leak was relatively low, and Device-associated thrombus was infrequent. Neither was associated with increased risk for thromboembolism.
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incidence and clinical impact of Device associated thrombus and peri Device leak following left atrial appendage closure with the amplatzer cardiac plug
Jacc-cardiovascular Interventions, 2017Co-Authors: Apostolos Tzikas, Joelle Kefer, Adel Aminian, Heyder Omran, Samera Shakir, Sameer Gafoor, Jens Erik Nielsenkudsk, Sergio Berti, Gennaro Santoro, Fabian NietlispachAbstract:Abstract Objectives Routine Device surveillance after successful left atrial appendage closure is recommended to evaluate for intermediate to late complications. The aim of this study was to assess the incidence and clinical impact of these complications on cardiovascular events. Methods Centers participating in the Amplatzer Cardiac Plug multicenter study were requested to submit their post-procedural transesophageal echocardiograms for independent adjudication. Thirteen of 22 centers contributed all their post-procedural echocardiograms, which included 344 from 605 consecutive patients. These images were submitted to a core laboratory and reviewed by 2 independent experts for peri-Device leak, Device-associated thrombus, Device Embolization, Device migration, left atrial appendage thrombus, and left atrial thrombus. Clinical events were prospectively collected by each center. Results Of the 344 transesophageal echocardiograms, 339 were deemed analyzable. Patients’ mean age was 74.4 ± 7.5 years, and 67.3% were men. The mean CHADS2 score was 2.7 ± 1.3, the mean CHA2DS2-VASc score was 4.3 ± 1.5, and the mean HAS-BLED score was 3.0 ± 1.2. Amplatzer Cardiac Plug implantation was successful in all patients. Periprocedural major adverse events occurred in 2.4%. Median clinical follow-up duration was 355 days (range 179 to 622 days). Follow-up transesophageal echocardiography was performed after a median of 134 days (range 88 to 227 days). Device-associated thrombus was observed in 3.2% and peri-Device leak in 12.5% (5.5% minimal, 5.8% mild, 0.6% moderate, 0.6% severe). Neither Device-associated thrombus nor peri-Device leak was associated with an increased risk for cardiovascular events. Independent predictors of Device-associated thrombus were smoking (odds ratio: 5.79; p = 0.017) and female sex (odds ratio: 4.22; p = 0.027). Conclusions Following successful left atrial appendage closure with the Amplatzer Cardiac Plug, the presence of peri-Device leak was relatively low, and Device-associated thrombus was infrequent. Neither was associated with increased risk for thromboembolism.
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long term results of a randomized trial comparing three different Devices for percutaneous closure of a patent foramen ovale
European Heart Journal, 2013Co-Authors: Marius Hornung, Margaret Taaffe, Stefan C Bertog, Jennifer Franke, Dani Id, Nina Wunderlich, Laura Vaskelyte, Ilona Hofmann, Horst SievertAbstract:Aims Percutaneous patent foramen ovale (PFO) closure for secondary stroke prevention is discussed controversially. Long-term data comparing different closure Devices are limited. The objective is the prospective comparison of procedural complications and long-term results after PFO closure in patients with cryptogenic stroke randomized to three different closure Devices. Methods and results Between January 2001 and December 2004, 660 patients with cryptogenic stroke were randomized to three different closure Devices (Amplatzer, CardioSEAL-STARflex, and Helex occluder, 220 patients per group). The primary endpoint was defined as recurrent cerebral ischaemia [stroke, transient ischaemic attacks (TIA), or Amaurosis fugax], death from neurological cause, or any other paradoxical embolism within 5 years after the index procedure. Device implantation was technically successful in all interventions ( n = 660; 100%). The procedure was complicated by pericardial tamponade requiring surgery in one patient (Amplatzer group) and Device Embolization in three patients (all Helex group). Thrombus formation on the Device was detected in 12 cases (11 CardioSEALSTARflex, 1 Helex, 0 Amplatzer; P < 0.0001), of which 2 required surgery. Complete closure after single Device implantation was more common with the Amplatzer and with the CardioSEAL-STARflex than with the Helex occluder: Amplatzer vs. Helex vs. CardioSEAL-STARflex: n = 217 (98.6%) vs. n = 202 (91.8%) vs. n = 213 (96.8%; P = 0.0012). Within 5 years of follow-up, the primary endpoint occurred in 25 patients (3.8%; 10 TIAs, 12 strokes and 3 cases of cerebral death). Compared with the CardioSEAL-STARflex (6%; 6 TIAs, 6 strokes, 1 cerebral death) and Helex groups (4%; 4 TIAs, 4 stroke, 1 cerebral death), significantly fewer events ( P = 0.04) occurred in the Amplatzer group (1.4%; 2 strokes, 1 cerebral death). Conclusion Although procedural complications and long-term neurological event rates are low regardless of the Device used, the recurrent neurological event rate was significantly lower after Amplatzer than after CardioSEAL-STARflex or Helex implantation. This has important implications regarding the interpretation of trials comparing PFO closure with medical management.
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closure of atrial septal defect with the amplatzer septal occluder in adults
American Journal of Cardiology, 2009Co-Authors: Nicolas Majunke, Nina Wunderlich, Jacek Bialkowski, Neil Wilson, Malgorzata Szkutnik, Jacek Kusa, Andreas Baranowski, Corinna Heinisch, Stefan Ostermayer, Horst SievertAbstract:Transcatheter closure of atrial septal defects (ASDs) was performed mainly in children and adolescents. Information about outcome and complications in adults was limited. From November 1997 to November 2005, percutaneous closure of ASDs using the Amplatzer septal occluder was attempted in 650 consecutive adult patients. Median patient age was 45.8 ± 16.2 years (range 18 to 90), mean systolic artery pressure was 33.3 ± 10.6 mm Hg (range 11 to 85), and mean pulmonary and systemic blood flow (Qp/Qs) ratio was 1.9 ± 0.7 (range 0.8 to 6.6). Mean stretched diameter of the ASD was 21.2 ± 5.1 mm (range 3.1 to 43). Seventy-eight patients (12%) had multiple defects. Of 572 patients with a single ASD, Device implantation was successful in 563 patients (98%). During follow-up, complete closure could be achieved in 96% of patients with a single ASD and 71% of patients with multiple defects. Mean systolic artery pressure decreased to 28.3 ± 10.1 mm Hg and mean Qp/Qs ratio decreased to 1 ± 0.3. The 3 complications that occurred during the procedure were Device Embolization (2 patients; 0.3%) and transient ST depression (1 patient; 0.2%). The most common complication immediately after the procedure and during follow-up was new-onset atrial fibrillation (28 patients; 4.3%). Electrical cardioversion was successfully in most. Complications requiring emergency or elective surgery occurred in 6 patients (0.9%; hemopericardium, 2 patients, 0.3%; Device Embolization, 3 patients, 0.5%, and pericardial tamponade, 1 patient, 0.2%). In conclusion, closure of ASDs using the Amplatzer septal occluder in adults was efficient and safe, with excellent long-term success rates. Serious complications were rare.
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percutaneous left atrial appendage transcatheter occlusion to prevent stroke in high risk patients with atrial fibrillation early clinical experience
Circulation, 2002Co-Authors: Horst Sievert, Michael D Lesh, Thomas Trepels, Heyder Omran, Antonio L Bartorelli, Paola Della Bella, Toshiko Nakai, Mark Reisman, Carlo Dimario, Peter C BlockAbstract:Background— Thromboembolism due to atrial fibrillation (AF) is a frequent cause of stroke. More than 90% of thrombi in AF form in the left atrial appendage (LAA). Obliteration of the appendage may prevent embolic complications. Methods and Results— We evaluated the feasibility and safety of implanting a novel Device for percutaneous left atrial appendage transcatheter occlusion (PLAATO). LAA occlusion using the PLAATO system was attempted in 15 patients with chronic AF at high risk for stroke, who are poor candidates for long-term warfarin therapy. The implant consists of a self-expanding nitinol cage covered with a polymeric membrane (ePTFE). The LAA was successfully occluded in 15/15 patients (100%). Angiography and transesophageal echocardiography (TEE) during the procedure showed that the Device was well-seated in all patients and that there was no evidence of perforation, Device Embolization, or interference with surrounding structures. In 1 patient, the first procedure was complicated by a hemoperic...
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transcatheter closure of atrial septal defect and patent foramen ovale with the asdos Device a multi institutional european trial
American Journal of Cardiology, 1998Co-Authors: Horst Sievert, Uros U Babic, Gerd Hausdorf, Martin Schneider, Hans W Hopp, Dietrich Pfeiffer, Matthias Pfisterer, Beat Friedli, Philip UrbanAbstract:A clinical trial was conducted to assess the feasibility, safety, and efficacy of the atrial septal defect (ASD) occlusion system for transcatheter closure of secundum ASD and patent foramen ovale (PFO) after episodes of cerebral embolism. Occlusion was attempted in 200 patients aged 1 to 74 years (mean 32). The procedure failed in 26 patients (13%); the Device was retrieved through a catheter in 20 and through surgery in 6 patients. Procedure-related complications necessitating surgical removal of the Device included Device Embolization in 2, Device entrapment within the Chiari network in 1, frame fracture in 1, and perforation of atrial wall in 2. All 6 patients experienced an uneventful postoperative course. An additional 11 patients (6%) underwent surgical removal of the Device during follow-up. There were 163 patients (81%) with an implanted ASD occlusion system at follow-up of from 6 to 36 months (mean 17). Thrombus formation around the Device was detected by transesophageal echocardiography in 9 patients 1 to 4 weeks after implantation. One of these patients (who had a coagulation factor XII deficiency) suffered a cerebral thromboembolism. Late atrial wall perforation (5, 6, and 8 months after implantation) occurred in 3 adult patients. Infectious endocarditis developed in 2 adult patients (1%). No late Device Embolization and no atrioventricular valve injury occurred. An asymptomatic Device frame fracture was found in 14% and frame deformity in 4% of all patients during the follow-up period of >230 patient-years. Immediately after closure, a moderate/large residual shunt remained in 8% and a small shunt in 29% of patients. After 1 year, a moderate/large shunt was present in 2% and a small one in 26% of patients. During a total follow-up of 49 patient-years, only 1 of 46 patients with PFO had a transient neurologic event after the closure. The study indicates that patients with centrally situated secundum ASD and those with PFO after cerebral embolism can be treated with this system with a high success rate and an acceptable morbidity.