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https://www.readbyqxmd.com/read/29440625/safety-and-feasibility-of-a-novel-active-fixation-temporary-pacing-lead
#1
Mark Webster, Sanjeevan Pasupati, Nigel Lever, Martin Stiles
OBJECTIVE: This first-in-human study evaluated the safety and technical feasibility of the Tempo temporary cardiac pacing lead (BioTrace Medical), which includes a novel fixation mechanism and soft tip. BACKGROUND: Complications of temporary pacing leads include dislodgment, arrhythmias, and ventricular perforation. Temporary pacing applications have increased with transcatheter aortic valve replacement (TAVR) growth, for rapid pacing during balloon valvuloplasty (BAV) and valve deployment, and for periprocedural bradyarrhythmia support...
February 15, 2018: Journal of Invasive Cardiology
https://www.readbyqxmd.com/read/29432364/per-ventricular-insertion-of-melody-valve-in-valve-in-the-neoaortic-position-in-a-single-ventricle-patient
#2
Nicholas S Clarke, Howaida El-Said, John J Lamberti, Raghav A Murthy
Percutaneous therapies for congenital heart disease have been evolving rapidly despite limited investment from industry. The Melody transcatheter pulmonary valve (Medtronic, Inc, Minneapolis, MN USA) replacement therapy represents an important advancement in this arena. It has been approved in the United States for use in the pulmonary position, on a Humanitarian Device Exemption status. Off-label use of the Melody transcatheter pulmonary valve has extended to the mitral, pulmonary, and aortic valves, especially in previously implanted valves with prosthetic valve degeneration...
February 9, 2018: Innovations: Technology and Techniques in Cardiothoracic and Vascular Surgery
https://www.readbyqxmd.com/read/29401266/randomized-trial-of-the-carpentier-edwards-supra-annular-prosthesis-versus-the-medtronic-mosaic-aortic-prosthesis-10-year-results
#3
Omar Zibdeh, Ian Bugg, Shriyam Patel, Gina Twine, Jonathan Unsworth-White
OBJECTIVES: We performed a prospective randomized study comparing the clinical performance of the Carpentier-Edwards supra-annular valve (CE-SAV) (Edwards Lifesciences, Irvine, CA, USA) and the newer Mosaic (Medtronic Corporation, Minneapolis, MN, USA) porcine bioprostheses in the aortic position over a 10-year period. METHODS: Between January 2001 and March 2005, 398 patients undergoing bioprosthetic aortic valve replacement were randomized to receive either the CE-SAV (n = 193) or the Mosaic (n = 205) prosthesis...
February 1, 2018: European Journal of Cardio-thoracic Surgery
https://www.readbyqxmd.com/read/29395214/transcatheter-pulmonary-valve-replacement-using-the-melody-valve-for-treatment-of-dysfunctional-surgical-bioprostheses-a-multicenter-study
#4
Allison K Cabalka, Jeremy D Asnes, David T Balzer, John P Cheatham, Matthew J Gillespie, Thomas K Jones, Henri Justino, Dennis W Kim, Te-Hsin Lung, Daniel R Turner, Doff B McElhinney
BACKGROUND: Stented bioprosthetic valves (BPVs) are commonly used for surgical pulmonary valve (PV) replacement in postoperative congenital heart disease, but develop structural failure in a time-related fashion. The Melody transcatheter PV (TPV) (Medtronic, Minneapolis, Minn) has been used to treat BPV dysfunction, but there have been few studies in this population. METHODS: We performed a retrospective, multicenter study to evaluate Melody valve function in patients who underwent TPV replacement (TPVR) into a dysfunctional pulmonary BPV...
December 6, 2017: Journal of Thoracic and Cardiovascular Surgery
https://www.readbyqxmd.com/read/29377318/trans-carotid-access-for-tavr-allows-safe-and-rapid-exchange-for-bailout-valve-in-valve-procedures
#5
Enrico Ferrari, Elena Caporali, Giovanni Pedrazzini, Stefanos Demertzis
Trans-carotid access for trans-catheter aortic valve replacement is a valid alternative in patients with aortic valve dysfunction, severe peripheral vascular disease, and high-risk for surgery. However, in the event of the need for a bailout valve-in-valve procedure, the safety of this access site is uncertain. We report a patient with aortic regurgitation, previous coronary surgery, peripheral vascular disease, and impaired ventricular function who underwent a CoreValve Evolut-R (Medtronic Inc, Minneapolis, MN) implantation through the left carotid artery followed by a successful valve-in-valve procedure with a 26-mm Edwards Sapien3 valve (Edwards Lifesciences, Irvine, CA) through the same carotid access site...
January 28, 2018: Journal of Cardiac Surgery
https://www.readbyqxmd.com/read/29352701/bailout-surgical-explantation-of-a-transcatheter-valve-in-valve-for-subacute-thrombosis-when-there-is-no-time-for-anticoagulation-case-report-and-literature-review
#6
Francesco Notaristefano, Matteo Rocco Reccia, Salvatore Notaristefano, Roberto Annunziata, Rocco Sclafani, Giuseppe Ambrosio, Claudio Cavallini
Trancatheter heart valve (THV) thrombosis is effectively treated with anticoagulation but alternative therapies are required when a faster gradient reduction is needed. Open heart surgery has been rarely performed due to the high perioperative mortality and only five cases have been described so far. Here we describe a case of emergent surgical explantation for THV thrombosis after a valve-in-valve. A 67years old man underwent transcatheter aortic valve implantation for a failed surgical bioprosthesis Epic 21mm (St...
December 13, 2017: Cardiovascular Revascularization Medicine: Including Molecular Interventions
https://www.readbyqxmd.com/read/29348010/early-outcomes-with-the-evolut-pro-repositionable-self-expanding-transcatheter-aortic-valve-with-pericardial-wrap
#7
John K Forrest, Abeel A Mangi, Jeffrey J Popma, Kamal Khabbaz, Michael J Reardon, Neal S Kleiman, Steven J Yakubov, Daniel Watson, Susheel Kodali, Isaac George, Peter Tadros, George L Zorn, John Brown, Robert Kipperman, Sara Saul, Hongyan Qiao, Jae K Oh, Mathew R Williams
OBJECTIVES: This study sought to evaluate the Medtronic Evolut PRO Transcatheter Aortic Valve System in patients with severe symptomatic aortic stenosis. BACKGROUND: A next-generation self-expanding transcatheter aortic valve was designed with an external pericardial wrap with the intent to reduce paravalvular leak while maintaining the benefits of a low-profile, self-expanding, and repositionable supra-annular valve. METHODS: The Medtronic Evolut PRO Clinical Study included 60 patients undergoing transcatheter aortic valve replacement with the Evolut PRO valve at 8 investigational sites in the United States...
January 22, 2018: JACC. Cardiovascular Interventions
https://www.readbyqxmd.com/read/29302948/the-hancock%C3%A2-valved-conduit-for-right-ventricular-outflow-tract-reconstruction-in-sheep-for-assessing-new-devices
#8
John P Carney, Lindsey M Zhang, Jeffrey J Larson, Matthew T Lahti, Nicholas A Robinson, Agustin P Dalmasso, Richard W Bianco
BACKGROUND: Xenograft conduits have been used successfully to repair congenital heart defects, but are prone to failure over time. Hence, in order to improve patient outcomes, better xenografts are being developed. When evaluating a conduit's performance and safety it must first be compared against a clinically available control in a large animal model. The study aim was to evaluate a clinically available xenograft conduit used in right ventricular outflow tract (RVOT) reconstruction in a sheep model...
July 2017: Journal of Heart Valve Disease
https://www.readbyqxmd.com/read/29288660/novel-treatment-of-a-degenerated-bioroot-with-the-use-of-the-sutureless-valve-technique
#9
Thijs Stoker, Ahmed Mashhour, Jerry Easo, Kay Kronberg, Jürgen Ennker, Alexander Weymann
We describe three patients with severe aortic regurgitation after aortic root replacement using the Medtronic Freestyle® bioprosthesis. In two cases, the indication was endocarditis. The third case showed rupture of the right coronary cusp. To achieve fewer complications, lower operative risk and save operative and cross-clamp times, implantation of a sutureless bioprosthesis in a valve-in-valve manner was performed. In two cases, a Perceval bioprosthesis and in the other case, a 3f-Enable bioprosthesis were used...
December 27, 2017: Annals of Thoracic Surgery
https://www.readbyqxmd.com/read/29277931/percutaneous-pulmonary-valve-implantation-in-grown-up-congenital-heart-disease-patients-insights-from-the-zurich-experience
#10
Luca Oechslin, Roberto Corti, Matthias Greutmann, Oliver Kretschmar, Oliver Gaemperli
OBJECTIVES: The aim of the study was to assess indications, procedural success, complications, echocardiographic, and clinical outcomes of percutaneous pulmonary valve implantation (PPVI) in adult patients with congenital heart disease (CHD). BACKGROUND: PPVI offers a non-surgical treatment option for failing prosthetic conduits in pulmonary position. However, efficacy and clinical outcomes after PPVI are still underreported. METHODS: From January 2008 to March 2016, 25 adult CHD patients with right ventricular outflow tract (RVOT) stenosis and/or pulmonary regurgitation underwent PPVI in our institution...
December 25, 2017: Journal of Interventional Cardiology
https://www.readbyqxmd.com/read/29260712/in-vitro-hydrodynamic-and-acute-clinical-performance-of-a-novel-self-expanding-thv-in-various-surgical-bioprostheses
#11
Alexander Sedaghat, Jan-Malte Sinning, Nikos Werner, Georg Nickenig, Lenard Conradi, Stefan Toggweiler, Ulrich Schäfer
AIMS: The aim of this study was to assess the in-vitro hydrodynamic performance of a novel self-expanding transcatheter heart valve prosthesis (THV), the NVT AllegraTM, in 5 different surgical bioprostheses. In addition, we present a series of valve-in-valve implantations in the clinical setting using the 23mm AllegraTM prosthesis. METHODS AND RESULTS: The 23mm NVT AllegraTM was implanted in 5 different surgical bioprostheses of 23mm nominal size, namely the Edwards Perimount, the Sorin MitroFlow, the St...
December 19, 2017: EuroIntervention
https://www.readbyqxmd.com/read/29191782/comparison-of-the-hemodynamic-performance-of-the-balloon-expandable-sapien-3-versus-self-expandable-evolut-r-transcatheter-valve-a-case-matched-study
#12
Eduardo Enríquez-Rodríguez, Ignacio J Amat-Santos, Pilar Jiménez-Quevedo, Irene Martín-Morquecho, Gabriela Tirado-Conte, María José Pérez-Vizcayno, José Juan Gómez de Diego, Roman Arnold, Andrés Aldazábal, Paol Rojas, Alberto de Agustín, María Del Trigo, Hipólito Gutiérrez, José A San Román, Carlos Macaya, Luis Nombela-Franco
INTRODUCTION AND OBJECTIVES: The SAPIEN 3 (S3) valve and the Medtronic Evolut R (EVR) are second-generation transcatheter valves, designed to further reduce the rate of paravalvular aortic regurgitation (AoR). The aim of this study was to compare the 2 devices in terms of valve performance in a case-matched study with independent echocardiographic analysis. METHODS: Of a population of 201 patients who underwent transcatheter aortic valve implantation, 144 patients (S3, n = 80; EVR, n = 64) were matched according to aortic annulus diameter and aortic valve calcium score, as assessed by computed tomography...
November 27, 2017: Revista Española de Cardiología
https://www.readbyqxmd.com/read/29174390/direct-aortic-access-for-transcatheter-aortic-valve-replacement-using-a-self-expanding-device
#13
Daniel P O'Hair, Tanvir K Bajwa, Jeffrey J Popma, Daniel R Watson, Steven J Yakubov, David H Adams, Samin Sharma, Newell Robinson, George Petrossian, Michael Caskey, Timothy Byrne, Neal S Kleiman, Angie Zhang, Michael J Reardon
BACKGROUND: Transcatheter aortic valve replacement (TAVR) using a self-expanding valve has been shown to be superior to an open operation in high-risk patients. Extensive iliofemoral peripheral vascular disease can prohibit femoral access. In these cases, direct aortic (DA) implantation may be a suitable option. METHODS: The current analysis compared outcomes in patients undergoing TAVR with the self-expanding CoreValve prosthesis (Medtronic, Minneapolis, MN) by direct aortic (DA) access vs iliofemoral (IF) access...
November 21, 2017: Annals of Thoracic Surgery
https://www.readbyqxmd.com/read/29130587/pushing-boundaries-implantation-of-the-34-mm-medtronic-corevalve-in-patients-with-a-large-aortic-annulus
#14
Adham Elmously, Berhane Worku, S Chiu Wong, Arash Salemi
The relationship between adherence to the recommended CoreValve sizing parameters and clinical outcomes is not well known for the recently released 34 mm valve, which is currently the largest available transcatheter valve. There is a presumed temporal reduction in paravalvular regurgitation in patients who receive an in-range valve, however, certain patients possess annular dimensions that are too large. We therefore describe two patients with annular dimensions larger than the manufacturer recommended range for the 34 mm CoreValve, who despite this underwent transcatheter aortic valve replacement with excellent clinical outcomes...
November 11, 2017: Catheterization and Cardiovascular Interventions
https://www.readbyqxmd.com/read/29118326/incidence-predictors-and-outcome-of-prosthesis-patient-mismatch-after-transcatheter-aortic-valve-replacement-a-systematic-review-and-meta-analysis
#15
Yan-Biao Liao, Yi-Jian Li, Li Jun-Li, Zhen-Gang Zhao, Xin Wei, Jiay-Yu Tsauo, Tian-Yuan Xiong, Yuan-Ning Xu, Yuan Feng, Mao Chen
The aim of this study was to investigate the incidence, predictors and outcome of prosthesis-patient mismatch (PPM) following transcatheter aortic valve replacement (TAVR). A total of 30 articles incorporating 4,691 patients were identified. The pooled incidences of overall, moderate and severe PPM following TAVR were 33.0%, 25.0% and 11.0% respectively. Medtronic CoreValve (MCV) had lower incidence of overall (32% vs: 40%, P < 0.0001) and moderate (23% vs 32%, P < 0.0001) than Edwards Sapien (ESV)...
November 8, 2017: Scientific Reports
https://www.readbyqxmd.com/read/29102579/long-term-health-benefit-of-transcatheter%C3%A2-aortic-valve-replacement-in-patients-with%C3%A2-chronic-lung-disease
#16
Juan A Crestanello, Jeffrey J Popma, David H Adams, G Michael Deeb, Mubashir Mumtaz, Barry George, Jian Huang, Michael J Reardon
OBJECTIVES: This study sought to characterize the long-term effect of chronic lung disease (CLD) on mortality, clinical outcomes, quality of life, and health benefits after transcatheter aortic valve replacement (TAVR) with a self-expanding bioprosthesis. BACKGROUND: The long-term effect of CLD after TAVR is unknown. METHODS: Prevalence and severity of CLD was determined at baseline in high- and extreme-risk patients with aortic stenosis from the CoreValve US Pivotal Trial...
November 27, 2017: JACC. Cardiovascular Interventions
https://www.readbyqxmd.com/read/29101108/transthoracic-echocardiography-is-adequate-for-intraprocedural-guidance-of-transcatheter-aortic-valve-implantation
#17
Renuka Jain, Daniel P O'Hair, Tanvir K Bajwa, Denise Ignatowski, Daniel Harland, Amanda M Kirby, Tracy Hammonds, Suhail Q Allaqaband, Jonathan Kay, Bijoy K Khandheria
BACKGROUND: While transcatheter aortic valve implantation (TAVI) has traditionally been supported intraprocedurally by transoesophageal echocardiography (TOE), transthoracic echocardiography (TTE) is increasingly being used. We evaluated echocardiographic imaging characteristics and clinical outcomes in patients who underwent TTE during TAVI (TTE-TAVI). METHODS AND RESULTS: A select team of dedicated sonographers and interventional echocardiographers performed TTE-TAVI in 278 patients, all of whom underwent TAVI through transfemoral access...
December 2017: Echo Research and Practice
https://www.readbyqxmd.com/read/29100645/subclavian-axillary-access-for-self-expanding-transcatheter-aortic-valve-replacement-renders-equivalent-outcomes-as-transfemoral
#18
Thomas G Gleason, John T Schindler, Robert C Hagberg, G Michael Deeb, David H Adams, John V Conte, George L Zorn, G Chad Hughes, Jia Guo, Jeffrey J Popma, Michael J Reardon
BACKGROUND: Iliofemoral arterial disease can preclude transfemoral (TF) transcatheter aortic valve replacement (TF-TAVR). Transthoracic access by direct aortic or a transapical approach imparts a greater risk of complications and death than TF access. We hypothesized that subclavian/axillary arterial (SCA) access offers equivalent risks and outcomes as TF access. METHODS: The outcomes of 202 patients from the CoreValve (Medtronic, Minneapolis, MN) United States Pivotal Trial Program treated with SCA access were propensity matched with patients treated with TF access and analyzed...
November 1, 2017: Annals of Thoracic Surgery
https://www.readbyqxmd.com/read/29080095/from-corevalve-to-evolut-pro-reviewing-the-journey-of-self-expanding-transcatheter-aortic-valves
#19
REVIEW
Dhruv Mahtta, Islam Y Elgendy, Anthony A Bavry
Transcatheter aortic valve replacement (TAVR) has become standard therapy for patients with severe aortic stenosis who are deemed at least intermediate risk for surgical valve replacement. Over the past decade, several technological advances have taken place to improve the quality and safety of these devices. The current commercially available valves are broadly grouped into balloon expandable and self-expandable valves. The latest iteration of the self-expandable valve is Medtronic's repositionable valve known as the Evolut PRO system...
December 2017: Cardiology and Therapy
https://www.readbyqxmd.com/read/29068129/bicaval-medtronic-melody-valve-implantation-for-treatment-of-severe-mitral-regurgitation-following-the-mustard-repair-a-case-report
#20
Zachary L Steinberg, Brian H Morray, Thomas K Jones
We present a case of successful bicaval Melody valve implantation to treat severe mitral regurgitation in a 44-year-old man with d-transposition of the great arteries, repaired via a Mustard operation. The patient sustained injury to the anterior mitral valve leaflet during laser extraction of a ventricular pacing lead resulting in acute, severe, symptomatic mitral regurgitation. The presence of systemic venous baffles of similar caliber to right ventricular outflow tract conduits allowed for implantation of Melody valves within each baffle...
October 25, 2017: Catheterization and Cardiovascular Interventions
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