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https://www.readbyqxmd.com/read/28988455/safety-profiles-of-percutaneous-left-atrial-appendage-closure-devices-an-analysis-of-the-food-and-drug-administration-manufacturer-and-user-facility-device-experience-maude-database-from-2009-2016
#1
Mohammad-Ali Jazayeri, Venkat Vuddanda, Mohit K Turagam, Valay Parikh, Madhav Lavu, Donita Atkins, Matthew Earnest, Luigi Di Biase, Andrea Natale, David Wilber, Yeruva Madhu Reddy, Dhanunjaya Lakkireddy
BACKGROUND: Percutaneous left atrial appendage closure (LAAC) is a viable option for AF patients who are unable to tolerate long term oral anticoagulation (OAC). OBJECTIVE: We sought to assess the safety of two commonly used percutaneous devices for LAA closure in the United States by analysis of surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database. METHODS: The MAUDE database was queried between May 1, 2006 and May 1, 2016 for LARIAT® (SentreHEART Inc...
October 8, 2017: Journal of Cardiovascular Electrophysiology
https://www.readbyqxmd.com/read/28966159/transcatheter-left-atrial-appendage-occlusion-for-stroke-prevention-in-patients-with-atrial-fibrillation-results-from-the-belgian-registry
#2
Joelle Kefer, Adel Aminian, Paul Vermeersch, Tom De Potter, Francis Stammen, Edouard Benit, Werner Budts, Luc Missault, Benny Drieghe, Ian Buysschaert, Kristoff Cornelis, Jean-Manuel Herzet, Antoine Guedes, Nadia Debbas, Maximo Rivero, Mathieu Lempereur, Stijn Lochy, Ruben Casado-Arroyo, Christophe Laruelle, Philippe Debruyne, Thierry Ledent
AIMS: This study aimed at assessing the safety and efficacy at mid-term follow-up of left atrial appendage occlusion (LAAO) using different devices, in real life in Belgium. METHODS AND RESULTS: Between June 2009 and November 2016, 457 consecutive patients (63% males, 75±12 yrs, CHA2DS2-VASc 4±0.6, HASBLED 3.5±0.7) undergoing LAAO were included. Technical success was 97.1%. There were 19 periprocedural major adverse events (4.1%) including three deaths (0.6%), nine tamponades (1...
October 3, 2017: EuroIntervention
https://www.readbyqxmd.com/read/28928914/reducing-radiation-exposure-in-an-electrophysiology-lab-with-introduction-of-newer-fluoroscopic-technology
#3
Munish Sharma, Koroush Khalighi
The use of fluoroscopic devices exposes patients and operators to harmful effects of ionizing radiation in an electrophysiology (EP) lab. We sought to know if the newer fluoroscopic technology (Allura Clarity) installed in a hybrid EP helps to reduce prescribed radiation dose. We performed radiation dose analysis of 90 patients who underwent various procedures in the EP lab at a community teaching hospital after the introduction of newer fluoroscopic technology in June of 2016. Watchman device insertion, radiofrequency ablation procedures, permanent pacemaker (PPM)/implantable cardioverter defibrillator (ICD) placement and battery changes were included in the study to compare radiation exposure during different procedures performed commonly in an EP lab...
June 7, 2017: Clinics and Practice
https://www.readbyqxmd.com/read/28898453/echocardiographic-guidance-and-monitoring-of-left-atrial-appendage-closure-with-atriclip-during-open-chest-cardiac-surgery
#4
Rachele Contri, Sara Clivio, Tiziano Torre, Tiziano Cassina
Left atrial appendage (LAA) closure prevents thromboembolic risk and avoids lifelong anticoagulation due to atrial fibrillation (AF). Nowadays, AtriClip, a modern epicardial device approved in June 2010, allows external and safe closure of LAA in patients undergoing cardiac surgery during other open-chest cardiac surgical procedures. Such a surgical approach and its epicardial deployment differentiates LAA closure with AtriClip from percutaneous closure techniques such as Watchman (Boston Scientific, Marlborough, MA, USA), Lariat (SentreHEART Inc...
September 12, 2017: Echocardiography
https://www.readbyqxmd.com/read/28877379/short-term-safety-and-efficacy-of-left-atrial-appendage-closure-with-the-watchman-device-in-patients-with-small-left-atrial-appendage-ostia
#5
Ganesh Venkataraman, S Adam Strickberger, Shephal Doshi, Christopher R Ellis, Dhanunjaya Lakkireddy, S Patrick Whalen, Frank Cuoco
INTRODUCTION: Left atrial appendage (LAA) closure with the WATCHMAN device, according to FDA labelling, is recommended in patients with a maximal LAA ostial width between 17 and 31 mm. The safety and efficacy of LAA closure in patients with a maximal LAA ostial width < 17 mm has not been evaluated. The goal of this study was to determine the acute and short-term safety and efficacy of LAA closure with the WATCHMAN device in patients with a maximal LAA ostial width < 17 mm...
September 6, 2017: Journal of Cardiovascular Electrophysiology
https://www.readbyqxmd.com/read/28818408/serial-assessment-of-natriuretic-peptides-in-patients-undergoing-interventional-closure-of-the-left-atrial-appendage
#6
Blerim Luani, Thomas Rauwolf, Thomas Groscheck, Ivan Tanev, Joerg Herold, Berend Isermann, Alexander Schmeisser, Rüdiger C Braun-Dullaeus
BACKGROUND: Closure of the left atrial appendage (LAA) to prevent cardioembolic events is an alternative therapy to oral anticoagulation in patients with non-valvular atrial fibrillation. The LAA is an important source of natriuretic peptides and its exclusion from the circulation may alter the blood level of these hormones, thereby influencing their diagnostic value and clinical effects. METHODS: We aimed to prospectively assess potential changes in mid-regional pro A-type natriuretic peptide (MR-proANP) and N-terminal pro B-type natriuretic peptide (NT-proBNP) levels six weeks and six months after interventional LAA closure using the Watchman device...
August 1, 2017: Heart, Lung & Circulation
https://www.readbyqxmd.com/read/28761682/a-comparative-study-of-different-imaging-modalities-for-successful-percutaneous-left-atrial-appendage-closure
#7
Danny Hf Chow, Gintautas Bieliauskas, Fadi J Sawaya, Oscar Millan-Iturbe, Klaus F Kofoed, Lars Søndergaard, Ole De Backer
OBJECTIVES: Accurate sizing of the left atrial appendage (LAA) is essential when performing percutaneous LAA closure. This study aimed to compare different LAA imaging modalities and sizing methods in order to obtain successful LAA closure. BACKGROUND: Percutaneous LAA closure is an increasingly used treatment strategy to prevent stroke in patients with atrial fibrillation. LAA sizing has typically been done by 2D-transoesophageal echocardiography (TEE). METHODS: Patients who had a preprocedural TEE and preprocedural and postprocedural multislice CT (MSCT) were identified...
2017: Open Heart
https://www.readbyqxmd.com/read/28691913/real-time-fusion-of-echocardiography-and-fluoroscopy-allowing-for-successful-implantation-of-a-watchman-device-without-contrast-injection
#8
Adel Aminian, Mathieu Lempereur, Mohammed Ben Yedder, Philippe Dubois
No abstract text is available yet for this article.
July 11, 2017: EuroIntervention
https://www.readbyqxmd.com/read/28675629/long-term-follow-up-after-left-atrial-appendage-occlusion-with-comparison-of-transesophageal-echocardiography-versus-computed-tomography-to-guide-medical-therapy-and-data-about-postclosure-cardioversion
#9
Benjamin Berte, Christine Attenhofer Jost, Dominik Maurer, Anja Fäh-Gunz, Xavier Pillois, Barbara Naegeli, Monica Pfyffer, Gabor Sütsch, Christoph Scharf
AIMS: The use of left atrial appendage (LAA) occluders in atrial fibrillation is increasing. There are few data on the comparison between transesophageal echocardiography (TEE) and computed tomography (MDCT) assessing peridevice flow and outcome of electrical cardioversion (ECV) in these patients. METHODS AND RESULTS: Single-center prospective registry from 2009 to 2015 including all LAA occluders to analyze success and complications during implantation and follow-up...
October 2017: Journal of Cardiovascular Electrophysiology
https://www.readbyqxmd.com/read/28673783/combined-mitraclip-implantation-and-left-atrial-appendage-occlusion-using-the-watchman-device-a-case-series-from-a-referral-center
#10
Ana Rita G Francisco, Eduardo Infante de Oliveira, Miguel Nobre Menezes, Pedro Carrilho Ferreira, Pedro Canas da Silva, Ângelo Nobre, Fausto J Pinto
INTRODUCTION: Patients referred for percutaneous transcatheter mitral valve repair using the MitraClip(®) system frequently have atrial fibrillation, which imposes additional challenges due to the need for oral anticoagulation. Left atrial appendage occlusion is currently regarded as a non-inferior alternative to anticoagulation in patients with non-valvular atrial fibrillation and both high thromboembolic and bleeding risk. Considering that both MitraClip implantation and left atrial appendage occlusion are percutaneous techniques that require transseptal puncture, it is technically attractive to consider their concomitant use...
July 2017: Portuguese Journal of Cardiology: An Official Journal of the Portuguese Society of Cardiology
https://www.readbyqxmd.com/read/28667807/improved-algorithm-for-ostium-size-assessment-in-watchman-left-atrial-appendage-occlusion-using-three-dimensional-echocardiography
#11
Maximilian Schmidt-Salzmann, Felix Meincke, Felix Kreidel, Tobias Spangenberg, Alexander Ghanem, Karl-Heinz Kuck, Martin W Bergmann
AIMS: Correct sizing of the ostium is a crucial step in left atrial appendage (LAA) occlusion procedures. However, unfavorable anatomy of the ostium often complicates the assessment of the true ostium diameter. We hypothesized that area-derived diameter (ADD) and perimeter-derived diameter (PDD) from three-dimensional transesophageal echocardiogram (3D-TEE) can facilitate this step of the procedure as compared with two-dimensional (2D) measurements. METHODS AND RESULTS: For 55 patients within the ALSTER-LAA registry, retrospective analysis of PDD and ADD was correlated with 2D measurements used during the procedure to ascertain correct size of the Watchman device (Boston Scientific)...
July 2017: Journal of Invasive Cardiology
https://www.readbyqxmd.com/read/28639873/anesthetic-management-of-patients-undergoing-percutaneous-endocardial-and-epicardial-left-atrial-appendage-occlusion
#12
Zeena Husain, Payam Safavi-Naeini, Abdi Rasekh, Mehdi Razavi, Charles D Collard, James M Anton, Daniel A Tolpin
Atrial fibrillation is the most common cardiac arrhythmia in adults affecting almost 6 million adults in the United States. The 2 most common comorbidities associated with atrial fibrillation are heart failure and thromboembolic events. Heart failure symptoms may be treated with rate control, antiarrhythmic medications or by catheter ablation. Unfortunately, despite optimal medical management, thromboembolic events still occur. Recently, there has been a great deal of interest and innovation in finding an alternative to chronic anticoagulation...
June 1, 2017: Seminars in Cardiothoracic and Vascular Anesthesia
https://www.readbyqxmd.com/read/28625383/the-assessment-of-the-watchman-device-in-patients-unsuitable-for-oral-anticoagulation-asap-too-trial
#13
RANDOMIZED CONTROLLED TRIAL
David R Holmes, Vivek Y Reddy, Maurice Buchbinder, Kenneth Stein, Myriah Elletson, Martin W Bergmann, Boris Schmidt, Jacqueline Saw
BACKGROUND: Oral anticoagulants (OACs) reduce stroke risks with nonvalvular atrial fibrillation (AF); however, they are underused because of absolute or relative contraindications due to real or perceived risk of bleeding. Although left atrial appendage closure is increasingly performed in OAC-ineligible patients, this has not been studied in a randomized controlled trial. STUDY OBJECTIVES: The ASAP-TOO study is designed to establish the safety and effectiveness of the Watchman left atrial appendage closure device in patients with nonvalvular AF who are deemed ineligible for OAC...
July 2017: American Heart Journal
https://www.readbyqxmd.com/read/28606886/early-anticoagulation-drug-regimens-after-watchman-left-atrial-appendage-closure-safety-and-efficacy
#14
Martin W Bergmann, Timothy R Betts, Horst Sievert, Boris Schmidt, Evgeny Pokushalov, Stephan Kische, Thomas Schmitz, Felix Meincke, Kenneth M Stein, Lucas V Boersma, Hüseyin Ince
AIMS: While LAA closure has recently been incorporated in both European and US guidelines for stroke prevention, uncertainties regarding post-procedural drug therapy so far limit its adoption. METHODS AND RESULTS: 1005 patients were implanted with a WATCHMAN device in the prospective EWOLUTION study at 47 centers. 73.5% of the patients were deemed contraindicated for long-term OAC therapy. Here we report on 3-months data including the first follow-up TOE exam for 94% of the study population...
June 13, 2017: EuroIntervention
https://www.readbyqxmd.com/read/28595810/successful-percutaneous-retrieval-of-embolized-transcatheter-left-atrial-appendage-closure-device-watchman-using-a-modified-vascular-retrieval-forceps
#15
Zaher Fanari, Sachin Goel, Jeffrey A Goldstein
Transcatheter closure of the left atrial appendage (LAA) is increasingly considered as an alternative to oral anticoagulation in patients with previous major bleeding or at high-risk of bleeding. Device embolization with transcatheter LAA closure is a rare complication. Most cases are asymptomatic, but it can be life threatening. Depending on the location of embolization, percutaneous retrieval is feasible. Snares are usually used for retrieval, but other devices may be used. We report the case of a 63-year gentleman who underwent an uneventful LAA closure with Watchman device and routine testing next day showed embolization to the abdominal aorta...
May 31, 2017: Cardiovascular Revascularization Medicine: Including Molecular Interventions
https://www.readbyqxmd.com/read/28577840/efficacy-and-safety-of-left-atrial-appendage-closure-with-watchman-in-patients-with-or-without-contraindication-to-oral-anticoagulation-1-year-follow-up-outcome-data-of-the-ewolution-trial
#16
Lucas V Boersma, Hueseyin Ince, Stephan Kische, Evgeny Pokushalov, Thomas Schmitz, Boris Schmidt, Tommaso Gori, Felix Meincke, Alexey Vladimir Protopopov, Timothy Betts, David Foley, Horst Sievert, Patrizio Mazzone, Tom De Potter, Elisa Vireca, Kenneth Stein, Martin W Bergmann
BACKGROUND: Left atrial appendage (LAA) occlusion with WATCHMAN has emerged as viable alternative to vitamin K antagonists in randomized controlled trials. OBJECTIVE: EWOLUTION was designed to provide data in routine practice from a prospective multicenter registry. METHODS: A total of 1025 patients scheduled for a WATCHMAN implant were prospectively and sequentially enrolled at 47 centers. Indication for LAA closure was based on European Society of Cardiology guidelines...
May 31, 2017: Heart Rhythm: the Official Journal of the Heart Rhythm Society
https://www.readbyqxmd.com/read/28565887/safety-and-efficacy-of-catheter-based-left-atrial-appendage-closure-in-patients-with-contraindications-for-long-term-anticoagulation
#17
Adrian Seidel, Abdul S Parwani, Florian Krackhardt, Martin Huemer, Philipp Attanasio, Wilhelm Haverkamp, Burkert Pieske, Leif-Hendrik Boldt
BACKGROUND: Percutaneous left atrial appendage closure (LAAC) and the role of post interventional anticoagulation often evokes controversy in daily practice. This study aimed to evaluate LAAC in patients with non-rheumatic atrial fibrillation, high thromboembolic risk and contraindications for long-term anticoagulation in a clinical scenario. METHODS AND RESULTS: Between 2010-2015, LAAC was attempted in 118 patients (47 women). Devices were successfully implanted in 95% (Watchman™ device n=97, St...
May 31, 2017: Minerva Cardioangiologica
https://www.readbyqxmd.com/read/28546017/delayed-left-atrial-appendage-contrast-filling-in-computed-tomograms-after-percutaneous-left-atrial-appendage-occlusion
#18
Yeong-Min Lim, Jung-Sun Kim, Tae-Hoon Kim, Jae-Sun Uhm, Chi Young Shim, Boyoung Joung, Geu-Ru Hong, Moon-Hyoung Lee, Yang-Soo Jang, Hui-Nam Pak
BACKGROUND: The gold standard for the follow-up of left atrial appendage occlusion (LAAO) is performing transesophageal echocardiogram (TEE) at 45 days after LAAO; however, the duration for complete LAA seal-off after percutaneous LAAO is unknown in humans. We retrospectively evaluated the LAA contrast-filling (CF) rate in follow-up cardiac computed tomography (CT) scans after LAAO. METHODS: We included 35 patients (age 67.5±10.9 years, CHA2DS2VASc 4.2±1.6, HAS-BLED 3...
May 22, 2017: Journal of Cardiology
https://www.readbyqxmd.com/read/28544491/rebuttal-with-regards-to-device-associated-thrombus-formation-after-left-atrial-appendage-occlusion-a-systematic-review-of-events-reported-with-the-watchman-the-amplatzer-cardiac-plug-and-the-amulet
#19
M Lempereur, A Aminian, J Saw
No abstract text is available yet for this article.
May 22, 2017: Catheterization and Cardiovascular Interventions
https://www.readbyqxmd.com/read/28537000/advances-in-clinical-cardiology-2016-a-summary-of-the-key-clinical-trials
#20
REVIEW
Alastair Gray, Conor McQuillan, Ian B A Menown
INTRODUCTION: The findings of many new cardiology clinical trials over the last year have been published or presented at major international meetings. This paper aims to describe and place in context a summary of the key clinical trials in cardiology presented between January and December 2016. METHODS: The authors reviewed clinical trials presented at major cardiology conferences during 2016 including the American College of Cardiology (ACC), European Association for Percutaneous Cardiovascular Interventions (EuroPCR), European Society of Cardiology (ESC), European Association for the Study of Diabetes (EASD), Transcatheter Cardiovascular Therapeutics (TCT), and the American Heart Association (AHA)...
July 2017: Advances in Therapy
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