Heart Valve Replacement

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S.p. Hoerstrup - One of the best experts on this subject based on the ideXlab platform.

  • next generation tissue engineered Heart Valves with repair remodelling and regeneration capacity
    Nature Reviews Cardiology, 2020
    Co-Authors: Emanuela S Fioretta, Fpt Frank Baaijens, S.p. Hoerstrup, Volkmar Falk, Sarah E Motta, Valentina Lintas, Sandra S Loerakker, Kevin Kit Parker, Maximilian Y. Emmert
    Abstract:

    Valvular Heart disease is a major cause of morbidity and mortality worldwide. Surgical Valve repair or Replacement has been the standard of care for patients with valvular Heart disease for many decades, but transcatheter Heart Valve therapy has revolutionized the field in the past 15 years. However, despite the tremendous technical evolution of transcatheter Heart Valves, to date, the clinically available Heart Valve prostheses for surgical and transcatheter Replacement have considerable limitations. The design of next-generation tissue-engineered Heart Valves (TEHVs) with repair, remodelling and regenerative capacity can address these limitations, and TEHVs could become a promising therapeutic alternative for patients with valvular disease. In this Review, we present a comprehensive overview of current clinically adopted Heart Valve Replacement options, with a focus on transcatheter prostheses. We discuss the various concepts of Heart Valve tissue engineering underlying the design of next-generation TEHVs, focusing on off-the-shelf technologies. We also summarize the latest preclinical and clinical evidence for the use of these TEHVs and describe the current scientific, regulatory and clinical challenges associated with the safe and broad clinical translation of this technology. Next-generation tissue-engineered Heart Valves (TEHVs) are a promising therapeutic option for patients with valvular Heart disease. In this Review, Emmert and colleagues discuss the current Heart Valve Replacement options, describe the design of TEHVs and summarize the data from preclinical and clinical studies on the use of TEHVs.

  • The future of Heart Valve Replacement: recent developments and translational challenges for Heart Valve tissue engineering
    Journal of Tissue Engineering and Regenerative Medicine, 2017
    Co-Authors: Emanuela S Fioretta, Maximilian Y. Emmert, Petra E. Dijkman, S.p. Hoerstrup
    Abstract:

    Heart Valve Replacement is often the only solution for patients suffering from valvular Heart disease. However, currently available Valve Replacements require either life-long anti-coagulation or are associated with Valve degeneration and calcification. Moreover, they are suboptimal for young patients, because they do not adapt to the somatic growth. Tissue-engineering has been proposed as a promising approach to fulfill the urgent need for Heart Valve Replacements with regenerative and growth capacity. This review will start with an overview on the currently available Valve substitutes and the techniques for Heart Valve Replacement. The main focus will be on the evolution of and different approaches for Heart Valve tissue-engineering, namely the in-vitro, in-vivo, and in-situ approach. More specifically, several Heart Valve tissue-engineering studies will be discussed with regard to their shortcomings or successes and their possible suitability for novel minimally invasive implantation techniques. As in-situ Heart Valve tissue engineering based on cell-free functionalized starter materials is considered to be a promising approach for clinical translation, this review will also analyze the techniques used to tune the inflammatory response and cell recruitment upon implantation in order to stir a favorable outcome: controlling the blood-material interface, regulating the cytokine release, and influencing cell adhesion and differentiation. In the last section the authors provide their opinion about the future developments and the challenges towards clinical translation and adaptation of Heart Valve tissue engineering for Valve Replacement.

  • Regenerating Heart Valves
    Regenerating the Heart, 2011
    Co-Authors: Benedikt Weber, S.p. Hoerstrup
    Abstract:

    Valvular Heart disease is a significant cause of morbidity and mortality worldwide. Current options for surgical Heart Valve Replacement are associated with several major disadvantages as clinically available Valve prostheses represent nonviable structures and lack the potential to grow, repair, and remodel. Heart Valve tissue engineering represents a promising scientific concept to overcome these limitations, aiming at the fabrication of living autologous Heart Valves with a thromboresistant surface and a viable interstitium with repair and remodeling capabilities. Following the in vitro tissue engineering concept, autologous cells are harvested and seeded onto three-dimensional matrices followed by biomimetic conditioning enabling the development of neo-Heart Valve tissue. Here, we review the concept of both in vitro and in vivo Heart Valve tissue engineering, focusing in particular on different synthetic scaffold materials and available cell sources for the fabrication of living autologous Heart Valve substitutes.

  • In vitro Heart Valve tissue engineering.
    Methods in Molecular Medicine™, 2008
    Co-Authors: Dörthe Schmidt, Anita Mol, Jens M. Kelm, S.p. Hoerstrup
    Abstract:

    Heart Valve Replacement represents the most common surgical therapy for end-stage valvular Heart diseases. A major drawback all contemporary Heart Valve Replacements have in common is the lack of growth, repair, and remodeling capabilities. To overcome these limitations, the emerging field of tissue engineering is focusing on the in vitro generation of functional, living Heart Valve Replacements. The basic approach uses starter matrices of either decellularized xenogeneic or biopolymeric materials configured in the shape of the Heart Valve and subsequent cell seeding. Moreover, in vitro strategies using mechanical loading in bioreactor systems have been developed to improve tissue maturation. This chapter gives a short overview of the current concepts and provides detailed methods for in vitro Heart Valve tissue engineering.

Reiner Koerfer - One of the best experts on this subject based on the ideXlab platform.

  • international normalized ratio self management lowers the risk of thromboembolic events after prosthetic Heart Valve Replacement
    The Annals of Thoracic Surgery, 2008
    Co-Authors: Thomas Eitz, Heinrich Koertke, Otto Wagner, Soren Schenk, Dirk Fritzsche, Andreas Bairaktaris, Reiner Koerfer
    Abstract:

    Background Although prosthetic Valves are durable and easy to implant, the need for lifetime warfarin-based anticoagulation restricts their exclusive usage. We investigated if anticoagulation self-management improves outcome in a single-center series. Methods Between 1994 and 1998, 765 patients with prosthetic Valve Replacements were prospectively enrolled and randomized to receive conventional anticoagulation management by their primary physician (group 1, n=295) or to pursue anticoagulation self-management (group 2, n=470). A study head office was implemented to coordinate and monitor anticoagulation protocols, international normalized ratios (INR), and adverse events. Patients were instructed on how to obtain and test their own blood samples and to adjust warfarin dosages according to the measured INR (target range, 2.5 to 4). Results Mean INR values were slightly yet significantly smaller in group 1 than in group 2 (2.8 ± 0.7 vs 3.0 ± .6, p p p = 0.008). Bleeding events were similar in both groups. Time-related multivariate analysis identified INR self-management and higher INR as independent predictors for better outcome. Conclusions Anticoagulation self-management can improve INR profiles up to 2 years after prosthetic Valve Replacement and reduce adverse events. Current indications of prosthetic rather than biologic Valve implantations may be extended if the benefit of INR self-management is shown by future studies with longer follow-up.

  • self management of oral anticoagulation therapy improves long term survival in patients with mechanical Heart Valve Replacement
    The Annals of Thoracic Surgery, 2007
    Co-Authors: Heinrich Koertke, Otto Wagner, Armin Zittermann, Reiner Koerfer
    Abstract:

    Background The Early Self-Controlled Anticoagulation Trial has demonstrated that in patients with mechanical Heart Valve Replacement self-management of oral anticoagulation results in less major thromboembolic events than conventional measurement by the general practitioner. However, the effects of self-management on long-term survival are currently not known. Methods Nine hundred thirty patients participated in a follow-up study of the aforementioned trial (488 from the self-management group and 442 from the conventional group). Long-term survival was assessed 12 years after the study began using the intent-to treat analysis as well as the per protocol analysis. Univariate and multivariate analyses were performed in order to assess independent predictors of survival. Results In total, the 930 patients accrued 8,315 patient-years of observation. During follow-up, 236 patients died. According to the intent-to treat analysis, 10-year survival was 76.1% in the conventional group and 84.5% in the self-management group. The corresponding values for the per protocol analysis were 67.7% and 80.6%, respectively. Age, kind of Valve surgery, and study group were independent predictors of survival. Self-management of oral anticoagulation increased long-term survival by 23% (intent-to-treat analysis) and 33% (per protocol analysis), respectively, compared with conventional measurement by the general practitioner. Possible reasons for these advantageous results in the self-management group are fewer thromboembolic events due to a higher percentage of international normalized ratio values lying in the target range compared with the conventional group. Conclusions Data indicate that self-management of oral anticoagulation is a promising strategy in order to increase long-term survival in patients with mechanical prosthetic Valves.

Maximilian Y. Emmert - One of the best experts on this subject based on the ideXlab platform.

  • next generation tissue engineered Heart Valves with repair remodelling and regeneration capacity
    Nature Reviews Cardiology, 2020
    Co-Authors: Emanuela S Fioretta, Fpt Frank Baaijens, S.p. Hoerstrup, Volkmar Falk, Sarah E Motta, Valentina Lintas, Sandra S Loerakker, Kevin Kit Parker, Maximilian Y. Emmert
    Abstract:

    Valvular Heart disease is a major cause of morbidity and mortality worldwide. Surgical Valve repair or Replacement has been the standard of care for patients with valvular Heart disease for many decades, but transcatheter Heart Valve therapy has revolutionized the field in the past 15 years. However, despite the tremendous technical evolution of transcatheter Heart Valves, to date, the clinically available Heart Valve prostheses for surgical and transcatheter Replacement have considerable limitations. The design of next-generation tissue-engineered Heart Valves (TEHVs) with repair, remodelling and regenerative capacity can address these limitations, and TEHVs could become a promising therapeutic alternative for patients with valvular disease. In this Review, we present a comprehensive overview of current clinically adopted Heart Valve Replacement options, with a focus on transcatheter prostheses. We discuss the various concepts of Heart Valve tissue engineering underlying the design of next-generation TEHVs, focusing on off-the-shelf technologies. We also summarize the latest preclinical and clinical evidence for the use of these TEHVs and describe the current scientific, regulatory and clinical challenges associated with the safe and broad clinical translation of this technology. Next-generation tissue-engineered Heart Valves (TEHVs) are a promising therapeutic option for patients with valvular Heart disease. In this Review, Emmert and colleagues discuss the current Heart Valve Replacement options, describe the design of TEHVs and summarize the data from preclinical and clinical studies on the use of TEHVs.

  • The future of Heart Valve Replacement: recent developments and translational challenges for Heart Valve tissue engineering
    Journal of Tissue Engineering and Regenerative Medicine, 2017
    Co-Authors: Emanuela S Fioretta, Maximilian Y. Emmert, Petra E. Dijkman, S.p. Hoerstrup
    Abstract:

    Heart Valve Replacement is often the only solution for patients suffering from valvular Heart disease. However, currently available Valve Replacements require either life-long anti-coagulation or are associated with Valve degeneration and calcification. Moreover, they are suboptimal for young patients, because they do not adapt to the somatic growth. Tissue-engineering has been proposed as a promising approach to fulfill the urgent need for Heart Valve Replacements with regenerative and growth capacity. This review will start with an overview on the currently available Valve substitutes and the techniques for Heart Valve Replacement. The main focus will be on the evolution of and different approaches for Heart Valve tissue-engineering, namely the in-vitro, in-vivo, and in-situ approach. More specifically, several Heart Valve tissue-engineering studies will be discussed with regard to their shortcomings or successes and their possible suitability for novel minimally invasive implantation techniques. As in-situ Heart Valve tissue engineering based on cell-free functionalized starter materials is considered to be a promising approach for clinical translation, this review will also analyze the techniques used to tune the inflammatory response and cell recruitment upon implantation in order to stir a favorable outcome: controlling the blood-material interface, regulating the cytokine release, and influencing cell adhesion and differentiation. In the last section the authors provide their opinion about the future developments and the challenges towards clinical translation and adaptation of Heart Valve tissue engineering for Valve Replacement.

Emanuela S Fioretta - One of the best experts on this subject based on the ideXlab platform.

  • next generation tissue engineered Heart Valves with repair remodelling and regeneration capacity
    Nature Reviews Cardiology, 2020
    Co-Authors: Emanuela S Fioretta, Fpt Frank Baaijens, S.p. Hoerstrup, Volkmar Falk, Sarah E Motta, Valentina Lintas, Sandra S Loerakker, Kevin Kit Parker, Maximilian Y. Emmert
    Abstract:

    Valvular Heart disease is a major cause of morbidity and mortality worldwide. Surgical Valve repair or Replacement has been the standard of care for patients with valvular Heart disease for many decades, but transcatheter Heart Valve therapy has revolutionized the field in the past 15 years. However, despite the tremendous technical evolution of transcatheter Heart Valves, to date, the clinically available Heart Valve prostheses for surgical and transcatheter Replacement have considerable limitations. The design of next-generation tissue-engineered Heart Valves (TEHVs) with repair, remodelling and regenerative capacity can address these limitations, and TEHVs could become a promising therapeutic alternative for patients with valvular disease. In this Review, we present a comprehensive overview of current clinically adopted Heart Valve Replacement options, with a focus on transcatheter prostheses. We discuss the various concepts of Heart Valve tissue engineering underlying the design of next-generation TEHVs, focusing on off-the-shelf technologies. We also summarize the latest preclinical and clinical evidence for the use of these TEHVs and describe the current scientific, regulatory and clinical challenges associated with the safe and broad clinical translation of this technology. Next-generation tissue-engineered Heart Valves (TEHVs) are a promising therapeutic option for patients with valvular Heart disease. In this Review, Emmert and colleagues discuss the current Heart Valve Replacement options, describe the design of TEHVs and summarize the data from preclinical and clinical studies on the use of TEHVs.

  • The future of Heart Valve Replacement: recent developments and translational challenges for Heart Valve tissue engineering
    Journal of Tissue Engineering and Regenerative Medicine, 2017
    Co-Authors: Emanuela S Fioretta, Maximilian Y. Emmert, Petra E. Dijkman, S.p. Hoerstrup
    Abstract:

    Heart Valve Replacement is often the only solution for patients suffering from valvular Heart disease. However, currently available Valve Replacements require either life-long anti-coagulation or are associated with Valve degeneration and calcification. Moreover, they are suboptimal for young patients, because they do not adapt to the somatic growth. Tissue-engineering has been proposed as a promising approach to fulfill the urgent need for Heart Valve Replacements with regenerative and growth capacity. This review will start with an overview on the currently available Valve substitutes and the techniques for Heart Valve Replacement. The main focus will be on the evolution of and different approaches for Heart Valve tissue-engineering, namely the in-vitro, in-vivo, and in-situ approach. More specifically, several Heart Valve tissue-engineering studies will be discussed with regard to their shortcomings or successes and their possible suitability for novel minimally invasive implantation techniques. As in-situ Heart Valve tissue engineering based on cell-free functionalized starter materials is considered to be a promising approach for clinical translation, this review will also analyze the techniques used to tune the inflammatory response and cell recruitment upon implantation in order to stir a favorable outcome: controlling the blood-material interface, regulating the cytokine release, and influencing cell adhesion and differentiation. In the last section the authors provide their opinion about the future developments and the challenges towards clinical translation and adaptation of Heart Valve tissue engineering for Valve Replacement.

Heinrich Koertke - One of the best experts on this subject based on the ideXlab platform.

  • international normalized ratio self management lowers the risk of thromboembolic events after prosthetic Heart Valve Replacement
    The Annals of Thoracic Surgery, 2008
    Co-Authors: Thomas Eitz, Heinrich Koertke, Otto Wagner, Soren Schenk, Dirk Fritzsche, Andreas Bairaktaris, Reiner Koerfer
    Abstract:

    Background Although prosthetic Valves are durable and easy to implant, the need for lifetime warfarin-based anticoagulation restricts their exclusive usage. We investigated if anticoagulation self-management improves outcome in a single-center series. Methods Between 1994 and 1998, 765 patients with prosthetic Valve Replacements were prospectively enrolled and randomized to receive conventional anticoagulation management by their primary physician (group 1, n=295) or to pursue anticoagulation self-management (group 2, n=470). A study head office was implemented to coordinate and monitor anticoagulation protocols, international normalized ratios (INR), and adverse events. Patients were instructed on how to obtain and test their own blood samples and to adjust warfarin dosages according to the measured INR (target range, 2.5 to 4). Results Mean INR values were slightly yet significantly smaller in group 1 than in group 2 (2.8 ± 0.7 vs 3.0 ± .6, p p p = 0.008). Bleeding events were similar in both groups. Time-related multivariate analysis identified INR self-management and higher INR as independent predictors for better outcome. Conclusions Anticoagulation self-management can improve INR profiles up to 2 years after prosthetic Valve Replacement and reduce adverse events. Current indications of prosthetic rather than biologic Valve implantations may be extended if the benefit of INR self-management is shown by future studies with longer follow-up.

  • self management of oral anticoagulation therapy improves long term survival in patients with mechanical Heart Valve Replacement
    The Annals of Thoracic Surgery, 2007
    Co-Authors: Heinrich Koertke, Otto Wagner, Armin Zittermann, Reiner Koerfer
    Abstract:

    Background The Early Self-Controlled Anticoagulation Trial has demonstrated that in patients with mechanical Heart Valve Replacement self-management of oral anticoagulation results in less major thromboembolic events than conventional measurement by the general practitioner. However, the effects of self-management on long-term survival are currently not known. Methods Nine hundred thirty patients participated in a follow-up study of the aforementioned trial (488 from the self-management group and 442 from the conventional group). Long-term survival was assessed 12 years after the study began using the intent-to treat analysis as well as the per protocol analysis. Univariate and multivariate analyses were performed in order to assess independent predictors of survival. Results In total, the 930 patients accrued 8,315 patient-years of observation. During follow-up, 236 patients died. According to the intent-to treat analysis, 10-year survival was 76.1% in the conventional group and 84.5% in the self-management group. The corresponding values for the per protocol analysis were 67.7% and 80.6%, respectively. Age, kind of Valve surgery, and study group were independent predictors of survival. Self-management of oral anticoagulation increased long-term survival by 23% (intent-to-treat analysis) and 33% (per protocol analysis), respectively, compared with conventional measurement by the general practitioner. Possible reasons for these advantageous results in the self-management group are fewer thromboembolic events due to a higher percentage of international normalized ratio values lying in the target range compared with the conventional group. Conclusions Data indicate that self-management of oral anticoagulation is a promising strategy in order to increase long-term survival in patients with mechanical prosthetic Valves.

  • low dose international normalized ratio self management a promising tool to achieve low complication rates after mechanical Heart Valve Replacement
    The Annals of Thoracic Surgery, 2005
    Co-Authors: Heinrich Koertke, Kazutomo Minami, Otto Wagner, Arno Krian, Juergen Ennker, U Taborski, Armin Zittermann, G Tenderich, Mahmoud Elarousy, W P Klovekorn
    Abstract:

    Background International normalized ratio (INR) self-management can significantly reduce INR fluctuations, bleeding, and thromboembolic events compared with INR control managed by general practitioners. However, even patients with INR self-management may have an increased risk of bleeding if their INR value is above 3.5. This study evaluated the compliance, clinical complications, and survival of patients after mechanical Heart Valve Replacement with low-dose INR self-management compared with conventional-dose anticoagulation. Methods Group 1 (n = 908) received low-dose anticoagulation with a target INR range of 1.8 to 2.8 for aortic Valve Replacement and 2.5 to 3.5 for mitral or double Valve Replacement. Group 2 (n = 910) received conventional-dose anticoagulation with a target INR range of 2.5 to 4.5 for all Heart Valve prostheses. Results In groups 1 and 2, 76% and 75% of INR values, respectively, were in the target range. Results did not differ according to schooling and age. The rate of thromboembolic events per patient year was 0.18% in group 1 and 0.40% in group 2 ( p = 0.210). The rate of bleeding complications was 0.74% for group 1 and 1.20% for group 2 ( p = 0.502). In most patients with clinically relevant bleeding, these complications occurred although their measured INR values were below 3.5. The survival rate did not differ between the study groups ( p = 0.495). Conclusions Low-dose INR self-management is a promising tool to achieve low hemorrhagic complications without increasing the risk of thromboembolic complications. INR self-management is applicable for all patients in whom permanent anticoagulation therapy is indicated. Even INR values below 3.5 can bear the risk of bleeding complications.

  • inr self management permits lower anticoagulation levels after mechanical Heart Valve Replacement
    Circulation, 2003
    Co-Authors: Heinrich Koertke, Kazutomo Minami, Dietmar Boethig, Th Breymann, Dirk Seifert, Otto Wagner, N Atmacha, Arno Krian, Juergen Ennker, U Taborski
    Abstract:

    Background— The Early Self Controlled Anticoagulation Trial (ESCAT I) showed that anticoagulation self-management after mechanical Heart Valve Replacement decreased complication rates by maintaining INR levels closer to the target range than International Normalized Ratio (INR) home doctor management. The therapeutic range for the INR in that study was between 2.5 and 4.5 for all positions of prosthetic Valves. ESCAT II should find out whether lowering the target range for INR self-management would further reduce complication rates. Methods— ESCAT II is a prospective controlled randomized (Valves: St. Jude Medical Standard or Medtronic Hall, treatment: conventional/low-dose) multicenter study with 3 300 patients. We present interim results of 1 818 patients. 908 were categorized as having a low-dose target range, which was INR 1.8 to 2.8 for prostheses in aortic position and 2.5 to 3.5 for prostheses in mitral position or in combined Valve Replacement. The control group (conventional group) with 910 patie...