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Hans R Figulla - One of the best experts on this subject based on the ideXlab platform.
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transcatheter treatment of tricuspid regurgitation by caval valve implantation experimental evaluation of decellularized tissue valves in central venous position
Catheterization and Cardiovascular Interventions, 2015Co-Authors: Alexander Lauten, Adrian Laube, Harald Schubert, Sabine Bischoff, Sandor Nietzsche, Kim Horstkotter, Bhawana Poudelbochmann, Marcus Franz, Artur Lichtenberg, Hans R FigullaAbstract:BACKGROUND: Caval valve implantation has been suggested for transcatheter treatment of severe tricuspid regurgitation (TR). Combining the interventional technique with the promising surgical experience with decellularized valves, we sought to evaluate the Functional and structural outcome of decellularized pericardial tissue valves (dTVs) in the low-pressure venous circulation in a chronic model of TR. METHODS AND RESULTS: Sixteen pericardial tissue valves were heterotopically implanted in the inferior and superior vena cava in a sheep model (54–98 kg; median 74.5 kg, n = 8) of severe TR. The Devices were assembled using self-expanding nitinol stents and bovine pericardia decellularized by a detergent-based protocol (group dTV; n = 8). Glutaraldehyde-fixed pericardial tissue valves served as control (GaTV, n = 8). After 6 months, Device Function and structural maturation were analyzed using echocardiographic, histologic, immunohistologic, and electron microscopic approaches. After implantation, cardiac output increased significantly from 3.7 ± 1.1 l/min to 4.8 ± 1.1 l/min (P < 0.05) and competent valve Function was verified by angiography. At 6 months, angiographic and echocardiographic evaluation revealed moderate to severe regurgitation in all GaTV. In contrast, five of the eight dTVs Functioned well with only minor regurgitation. In these animals, autopsy revealed preserved valve structure with tender leaflets without signs of thrombosis or calcification. Conversely, GaTV showed severe degeneration with large calcification areas. Microscopic and histologic analysis confirmed endothelial repopulation in both valve types. However, additional interstitial reseeding was observed in decellularized valves. CONCLUSIONS: In the venous circulation in severe TR, decellularized valves show superior Functional performance compared to Ga-fixed tissue valves. Macroscopic and microscopic analyses suggest preserved structural integrity and advanced endothelial and interstitial repopulation with evidence of less degradation in dTV. © 2014 Wiley Periodicals, Inc.
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heterotopic transcatheter tricuspid valve implantation first in man application of a novel approach to tricuspid regurgitation
European Heart Journal, 2011Co-Authors: Alexander Lauten, Markus Ferrari, Khosro Hekmat, Ruediger Pfeifer, G Dannberg, Andreas Ragoschkeschumm, Hans R FigullaAbstract:Aims Transcatheter treatment of heart valve disease is well established today. However, for the treatment of tricuspid regurgitation (TR), no effective catheter-based approach is available. Herein, we report the first human case description of transcatheter treatment of severe TR in a 79-year-old patient with venous congestion and associated non-cardiac diseases. In this patient, surgical treatment had been declined and pharmacological therapy had been ineffective. After ex vivo and animal studies, the treatment of TR was performed by percutaneous caval valve implantation. Methods and results In a transcatheter approach through the right femoral vein, a custom-made self-expanding heart valve was implanted into the inferior vena cava (IVC). The Device was anchored in the IVC at the cavoatrial junction with the level of the valve aligned immediately above the hepatic inflow and protruding into the right atrium. After deployment, excellent valve Function was observed resulting in a marked reduction in caval pressure and an abolition of the ventricular wave in the IVC. Sequential echocardiographic exams over a follow-up period of 8 weeks confirmed continuous Device Function without paravalvular leakage or remaining venous regurgitation. The patient experienced improved physical capacity and was able to resume off-bed activities. There was no recurrence of right heart failure during follow-up and a partial reduction of ascites. The patient was discharged from hospital into a rehabilitation programme. Conclusion Transcatheter treatment of severe TR by caval valve implantation is feasible resulting in an immediate abolition of IVC regurgitation and mid-term clinical improvement. Thus, in selected non-surgical patients, caval valve implantation may become a therapeutic option to treat venous regurgitation and improve associated non-cardiac diseases. Further confirmatory experience with longer follow-up is required to evaluate the long-term clinical benefit of the procedure as well as potential deleterious effects.
Angelo Auricchio - One of the best experts on this subject based on the ideXlab platform.
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recommendations for post implant monitoring of patients with cardiovascular implantable electronic Devices where do we stand today
Europace, 2013Co-Authors: Niraj Varma, Angelo AuricchioAbstract:The 2008 Heart Rhythm Society (HRS)/European Heart Rhythm Association (EHRA) consensus document advocated the necessity of monitoring both Device Function and patient condition post-implantation of a cardiovascular implantable electronic Device (CIED). It recommended a regular calendar-based system of follow-up, but lacked supporting data.1 While generating a huge service commitment, the efficacy of this schedule with regard to patient safety, adherence, incidence of unscheduled encounters, and ability for problem detection were unknown at the time of publication. Furthermore, although follow-up could be accomplished by ‘in person or remote’ methods, the comparative efficacy of these respective techniques in achieving follow-up goals had remained untested until recently. Over the last few years large-scale prospective trials have addressed these questions. These are reviewed by Guedon et al. 2 and the results have been revealing. Moreover, based on such recent evidence, the 2012 EHRA/HRS consensus document has strongly advocated for the use of remote monitoring in patients with cardiac resynchronization therapy (CRT).3 Firstly, replacement of scheduled in-person evaluation with remote follow-up was tested. The underlying concept was that the bulk of conventional in-person scheduled evaluations do not trigger any changes in patient management, i.e. are ‘non-actionable’, and hence could be supplanted with remote follow-up.4 When tested, these theories were confirmed in patient populations implanted with pacemakers, implantable cardioverter defibrillators (ICDs), and CRTs.5–7 For example, TRUST results confirmed that actionability of 3 monthly (3, 6, 9, and 12 month) scheduled calendar-based checks (whether conventionally or remotely managed) was low (<10%), thus replaceable with remote …
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ishne ehra expert consensus on remote monitoring of cardiovascular implantable electronic Devices cieds
Europace, 2012Co-Authors: Sergio Dubner, David L Hayes, Angelo Auricchio, Jonathan S Steinberg, Panos E Vardas, Peter H Stone, Josep Brugada, Ryszard Piotrowicz, Paulus Kirchhof, Gunter BreithardtAbstract:We are in the midst of a rapidly evolving era of technology-assisted medicine. The field of telemedicine provides the opportunity for highly individualized medical management in a way that has never been possible before. Evolving medical technologies using cardiac implantable Devices (CIEDs) with capabilities for remote monitoring permit evaluation of multiple parameters of cardiovascular physiology and risk, including cardiac rhythm, Device Function, blood pressure values, the presence of myocardial ischaemia, and the degree of compensation of congestive heart failure. Cardiac risk, Device status, and response to therapies can now be assessed with these electronic systems of detection and reporting. This document reflects the extensive experience from investigators and innovators around the world who are shaping the evolution of this rapidly expanding field, focusing in particular on implantable pacemakers (IPGs), implantable cardioverter-defibrillators (ICDs), Devices for cardiac resynchronization therapy (CRT) (both, with and without defibrillation properties), loop recorders, and haemodynamic monitoring Devices. This document covers the basic methodologies, guidelines for their use, experience with existing applications, and the legal and reimbursement aspects associated with their use. To adequately cover this important emerging topic, the International Society for Holter and Noninvasive Electrocardiology (ISHNE) and the European Heart Rhythm Association (EHRA) combined their expertise in this field. We hope that the development of this field can contribute to improve care of our cardiovascular patients.
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ishne ehra expert consensus on remote monitoring of cardiovascular implantable electronic Devices cieds
Annals of Noninvasive Electrocardiology, 2012Co-Authors: Sergio Dubner, David L Hayes, Angelo Auricchio, Jonathan S Steinberg, Panos E Vardas, Peter H Stone, Josep Brugada, Ryszard Piotrowicz, Paulus Kirchhof, Gunter BreithardtAbstract:We are in the midst of a rapidly evolving era of technology-assisted medicine. The field of telemedicine provides the opportunity for highly individualized medical management in a way that has never been possible before. Evolving medical technologies using cardiac implantable Devices with capabilities for remote monitoring permit evaluation of multiple parameters of cardiovascular physiology and risk, including cardiac rhythm, Device Function, blood pressure values, the presence of myocardial ischaemia, and the degree of compensation of congestive heart failure. Cardiac risk, Device status, and response to therapies can now be assessed with these electronic systems of detection and reporting. This document reflects the extensive experience from investigators and innovators around the world who are shaping the evolution of this rapidly expanding field, focusing in particular on implantable pacemakers, implantable cardioverter defibrillators, Devices for cardiac resynchronization therapy (both with and without defibrillation properties), loop recorders, and hemodynamic monitoring Devices. This document covers the basic methodologies, guidelines for their use, experience with existing applications, and the legal and reimbursement aspects associated with their use. To adequately cover this important emerging topic, the International Society for Holter and Noninvasive Electrocardiology and the European Heart Rhythm Association combined their expertise in this field. We hope that the development of this field can contribute to improve care of our cardiovascular patients.
Sung Gap Im - One of the best experts on this subject based on the ideXlab platform.
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rollable microfluidic systems with microscale bending radius and tuning of Device Function with reconfigurable 3d channel geometry
ACS Applied Materials & Interfaces, 2017Co-Authors: Sung Gap ImAbstract:Flexible microfluidic system is an essential component of wearable biosensors to handle body fluids. A parylene-based, thin-film microfluidic system is developed to achieve flexible microfluidics with microscale bending radius. A new molding and bonding technique is developed for parylene microchannel fabrication. Bonding with nanoadhesive layers deposited by initiated chemical vapor deposition (iCVD) enables the construction of microfluidic channels with short fabrication time and high bonding strength. The high mechanical strength of parylene allows less channel deformation from the internal pressure for the thin-film parylene channel than bulk PDMS channel. At the same time, negligible channel sagging or collapse is observed during channel bending down to a few hundreds of micrometers due to stress relaxation by prestretch structure. The flexible parylene channels are also developed into a rollable microfluidic system. In a rollable microfluidics format, 2D parylene channels can be rolled around a capi...
Alexander Lauten - One of the best experts on this subject based on the ideXlab platform.
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transcatheter treatment of tricuspid regurgitation by caval valve implantation experimental evaluation of decellularized tissue valves in central venous position
Catheterization and Cardiovascular Interventions, 2015Co-Authors: Alexander Lauten, Adrian Laube, Harald Schubert, Sabine Bischoff, Sandor Nietzsche, Kim Horstkotter, Bhawana Poudelbochmann, Marcus Franz, Artur Lichtenberg, Hans R FigullaAbstract:BACKGROUND: Caval valve implantation has been suggested for transcatheter treatment of severe tricuspid regurgitation (TR). Combining the interventional technique with the promising surgical experience with decellularized valves, we sought to evaluate the Functional and structural outcome of decellularized pericardial tissue valves (dTVs) in the low-pressure venous circulation in a chronic model of TR. METHODS AND RESULTS: Sixteen pericardial tissue valves were heterotopically implanted in the inferior and superior vena cava in a sheep model (54–98 kg; median 74.5 kg, n = 8) of severe TR. The Devices were assembled using self-expanding nitinol stents and bovine pericardia decellularized by a detergent-based protocol (group dTV; n = 8). Glutaraldehyde-fixed pericardial tissue valves served as control (GaTV, n = 8). After 6 months, Device Function and structural maturation were analyzed using echocardiographic, histologic, immunohistologic, and electron microscopic approaches. After implantation, cardiac output increased significantly from 3.7 ± 1.1 l/min to 4.8 ± 1.1 l/min (P < 0.05) and competent valve Function was verified by angiography. At 6 months, angiographic and echocardiographic evaluation revealed moderate to severe regurgitation in all GaTV. In contrast, five of the eight dTVs Functioned well with only minor regurgitation. In these animals, autopsy revealed preserved valve structure with tender leaflets without signs of thrombosis or calcification. Conversely, GaTV showed severe degeneration with large calcification areas. Microscopic and histologic analysis confirmed endothelial repopulation in both valve types. However, additional interstitial reseeding was observed in decellularized valves. CONCLUSIONS: In the venous circulation in severe TR, decellularized valves show superior Functional performance compared to Ga-fixed tissue valves. Macroscopic and microscopic analyses suggest preserved structural integrity and advanced endothelial and interstitial repopulation with evidence of less degradation in dTV. © 2014 Wiley Periodicals, Inc.
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heterotopic transcatheter tricuspid valve implantation first in man application of a novel approach to tricuspid regurgitation
European Heart Journal, 2011Co-Authors: Alexander Lauten, Markus Ferrari, Khosro Hekmat, Ruediger Pfeifer, G Dannberg, Andreas Ragoschkeschumm, Hans R FigullaAbstract:Aims Transcatheter treatment of heart valve disease is well established today. However, for the treatment of tricuspid regurgitation (TR), no effective catheter-based approach is available. Herein, we report the first human case description of transcatheter treatment of severe TR in a 79-year-old patient with venous congestion and associated non-cardiac diseases. In this patient, surgical treatment had been declined and pharmacological therapy had been ineffective. After ex vivo and animal studies, the treatment of TR was performed by percutaneous caval valve implantation. Methods and results In a transcatheter approach through the right femoral vein, a custom-made self-expanding heart valve was implanted into the inferior vena cava (IVC). The Device was anchored in the IVC at the cavoatrial junction with the level of the valve aligned immediately above the hepatic inflow and protruding into the right atrium. After deployment, excellent valve Function was observed resulting in a marked reduction in caval pressure and an abolition of the ventricular wave in the IVC. Sequential echocardiographic exams over a follow-up period of 8 weeks confirmed continuous Device Function without paravalvular leakage or remaining venous regurgitation. The patient experienced improved physical capacity and was able to resume off-bed activities. There was no recurrence of right heart failure during follow-up and a partial reduction of ascites. The patient was discharged from hospital into a rehabilitation programme. Conclusion Transcatheter treatment of severe TR by caval valve implantation is feasible resulting in an immediate abolition of IVC regurgitation and mid-term clinical improvement. Thus, in selected non-surgical patients, caval valve implantation may become a therapeutic option to treat venous regurgitation and improve associated non-cardiac diseases. Further confirmatory experience with longer follow-up is required to evaluate the long-term clinical benefit of the procedure as well as potential deleterious effects.
Gunter Breithardt - One of the best experts on this subject based on the ideXlab platform.
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ishne ehra expert consensus on remote monitoring of cardiovascular implantable electronic Devices cieds
Europace, 2012Co-Authors: Sergio Dubner, David L Hayes, Angelo Auricchio, Jonathan S Steinberg, Panos E Vardas, Peter H Stone, Josep Brugada, Ryszard Piotrowicz, Paulus Kirchhof, Gunter BreithardtAbstract:We are in the midst of a rapidly evolving era of technology-assisted medicine. The field of telemedicine provides the opportunity for highly individualized medical management in a way that has never been possible before. Evolving medical technologies using cardiac implantable Devices (CIEDs) with capabilities for remote monitoring permit evaluation of multiple parameters of cardiovascular physiology and risk, including cardiac rhythm, Device Function, blood pressure values, the presence of myocardial ischaemia, and the degree of compensation of congestive heart failure. Cardiac risk, Device status, and response to therapies can now be assessed with these electronic systems of detection and reporting. This document reflects the extensive experience from investigators and innovators around the world who are shaping the evolution of this rapidly expanding field, focusing in particular on implantable pacemakers (IPGs), implantable cardioverter-defibrillators (ICDs), Devices for cardiac resynchronization therapy (CRT) (both, with and without defibrillation properties), loop recorders, and haemodynamic monitoring Devices. This document covers the basic methodologies, guidelines for their use, experience with existing applications, and the legal and reimbursement aspects associated with their use. To adequately cover this important emerging topic, the International Society for Holter and Noninvasive Electrocardiology (ISHNE) and the European Heart Rhythm Association (EHRA) combined their expertise in this field. We hope that the development of this field can contribute to improve care of our cardiovascular patients.
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ishne ehra expert consensus on remote monitoring of cardiovascular implantable electronic Devices cieds
Annals of Noninvasive Electrocardiology, 2012Co-Authors: Sergio Dubner, David L Hayes, Angelo Auricchio, Jonathan S Steinberg, Panos E Vardas, Peter H Stone, Josep Brugada, Ryszard Piotrowicz, Paulus Kirchhof, Gunter BreithardtAbstract:We are in the midst of a rapidly evolving era of technology-assisted medicine. The field of telemedicine provides the opportunity for highly individualized medical management in a way that has never been possible before. Evolving medical technologies using cardiac implantable Devices with capabilities for remote monitoring permit evaluation of multiple parameters of cardiovascular physiology and risk, including cardiac rhythm, Device Function, blood pressure values, the presence of myocardial ischaemia, and the degree of compensation of congestive heart failure. Cardiac risk, Device status, and response to therapies can now be assessed with these electronic systems of detection and reporting. This document reflects the extensive experience from investigators and innovators around the world who are shaping the evolution of this rapidly expanding field, focusing in particular on implantable pacemakers, implantable cardioverter defibrillators, Devices for cardiac resynchronization therapy (both with and without defibrillation properties), loop recorders, and hemodynamic monitoring Devices. This document covers the basic methodologies, guidelines for their use, experience with existing applications, and the legal and reimbursement aspects associated with their use. To adequately cover this important emerging topic, the International Society for Holter and Noninvasive Electrocardiology and the European Heart Rhythm Association combined their expertise in this field. We hope that the development of this field can contribute to improve care of our cardiovascular patients.