View on Amazon.com
https://www.amazon.com/dp/B0BPRDLFNH
Audio y Texto
- Original Volume Six: Interventional Cardiology for Disease Diagnosis and Cardiac Surgery for Condition Treatment
-
NEW GENRE Volume Six: Interventional Cardiology for Disease Diagnosis and Cardiac Surgery for Condition Treatment
This volume has the following three parts:
PART A: The eTOCs in Spanish in Audio format
PART B: The eTOCs in Bi-lingual format: Spanish and English in Text format
PART C: The Editorials of the original e-Books in English in Audio format
PART A: The eTOCs in Spanish in Audio format
Serie A: libros electrónicos acerca de las enfermedades cardiovasculares
SEXTO VOLUMEN
Cardiología intervencionista para el diagnóstico de enfermedades y cirugía cardíaca para el tratamiento de afecciones
(LIBRO 6 DE LA SERIE DE LIBROS ELECTRÓNICOS SOBRE BIOMEDICINA)
Traducción a español Montero Language Services
Disponible en Amazon.com desde el 24/12/2018
2018
https://www.amazon.com/dp/B07MKHDBHF
Justin D. Pearlman, MD, PhD, FACC
Editorials and Clinical Pearls, Author
y
Leaders in Pharmaceutical Business Intelligence
avivalev-ari@alum.berkeley.edu
Redactora jefe
Indice de contenidos electrónico (IDCe)
Los enlaces indicados llevan al contenido original en inglés
| MD | Licenciado/a en medicina y cirugía (Estados Unidos) |
| PhD | Doctorado/a |
| FCAP | Miembro distinguido del Colegio de anatomopatólogos de los Estados Unidos |
| FACC | Miembro distinguido del Colegio de cardiólogos de los Estados Unidos |
| RN | Enfermero/a titulado/a |
Listado de colaboradores
- Co-Editor, Series A Content Consultant, Author of Preface, Introduction and Summary to Part One and Part two, Epilogue, Author of Articles and Clinical Pearls:
Justin D. Pearlman MD ME PhD MA FACC
- Co-Editor, Author and Curator
- Co-Editor, Author and Curator, Editor-in-Chief, BioMed e-Series, 16 Volumes, Curator of Series A, Volumes 5 & Volume 6 electronic Table of Contents (eTOCs), Articles Curator and Lead Scientific Reporter
PREFACIO
por Justin D. Pearlman, MD, PhD, FACC
El alcance de lo expuesto a continuación aborda la cardiología intervencionista y la cirugía cardíaca desde varias perspectivas, incluida la experiencia personal de pacientes e intervencionistas, además de los aspectos médicos, sociales y empresariales, incluidos los principales avances biotécnicos.
Introducción del libro por Justin D. Pearlman, MD, PhD, FACC
Primera parte:
Tendencias en cardiología intervencionista y cirugía cardíaca
Introducción por Justin D. Pearlman, MD, PhD, FACC
Capítulo 1: Lecciones del pasado. Reconocimiento a los pioneros que contribuyeron al estudio del corazón humano
Capítulo 2: Atención sanitaria cardiovascular: valor y carga económica
Capítulo 3: Ensayos clínicos y aprobación de productos sanitarios por la FDA
Resumen por Justin D. Pearlman, MD, PhD, FACC
Los puntos clave de lo anterior son: compartir el impacto personal de tener o tratar una afección cardiovascular potencialmente letal; la importancia vital de las innovaciones para poder cambiar los resultados, y los retos y adversidades que afrontan tanto el paciente como el cuidador y los innovadores médicos. Se realizó un análisis de la carga que suponen las enfermedades cardiovasculares, y de las oportunidades, obstáculos y protecciones que hay en el camino hacia la difusión de soluciones.
Segunda parte:
Enfermedades cardiovasculares. Etiología,
diagnóstico y opciones de tratamiento
Introducción por Justin D. Pearlman, MD, PhD, FACC
Los siguientes capítulos se centran en las causas y los mecanismos de las enfermedades cardiovasculares, información que resulta crucial para identificar las oportunidades de prevención y mejora. La comprensión de los fundamentos genéticos (las plantillas de todas las proteínas implicadas) no solo clarifica el ajuste fino de la regulación por biorretroalimentación sino que también aporta “biomarcadores” (análisis de sangre) que aclaran el estado del paciente y su respuesta a los tratamientos. El proceso de gestión del contenido (un recorrido guiado por expertos con vínculos a las fuentes originales) se ha centrado particularmente en tres aspectos fundamentales: la enfermedad coronaria, los coágulos sanguíneos y la insuficiencia cardíaca. Los temas tratados son:
I. Enfermedades cardiovasculares: etiología
Capítulo 4: Arteriopatía coronaria e intervenciones coronarias
Capítulo 5: Genómica y biomarcadores de las enfermedades cardiovasculares
Capítulo 6: Circulación, coagulación y trombosis
Capítulo 7: Insuficiencia ventricular: dispositivos de asistencia quirúrgicos y no quirúrgicos
II. Enfermedades cardiovasculares: diagnóstico de episodios cardíacos urgentes
Capítulo 8: Imágenes cardíacas y principales modalidades del diagnóstico cardiovascular
Capítulo 9: Episodios cardíacos urgentes
III. Enfermedades cardiovasculares: diagnóstico y tratamiento de los trastornos cardiovasculares crónicos
Capítulo 10: Trastornos cardiovasculares crónicos
IV. Enfermedades cardiovasculares: opciones de tratamiento
Capítulo 11: Comparación de la cirugía de revascularización coronaria (CRC) con la intervención coronaria percutánea (ICP) o angioplastia coronaria
Capítulo 12: Tecnologías para mantener la circulación: ensanchamiento de una arteria estrechada mediante stents y armazones
Capítulo 13: Reemplazo, implante y reparación valvular
Capítulo 14: Modificación de la anatomía original del corazón: revolución en las tecnologías y métodos
Resumen por Justin D. Pearlman, MD, PhD, FACC
EPÍLOGO POR Justin D. Pearlman, MD, PhD, FACC
Gracias por acompañarnos en este viaje a través de las numerosas facetas de las enfermedades cardiovasculares y sus repercusiones. Si es o se convierte usted en un paciente o defensor del paciente, se enfrentará a decisiones importantes. Esperamos que la presentación del conocimiento de vanguardia sobre las diferentes opciones a su alcance le ayude a tomar la mejor decisión en cada momento.
- Si es usted un innovador, esperamos que la presentación mediante ejemplos, además de los aspectos comerciales y normativos, le ayude a seguir contribuyendo a la mejora del manejo de la carga prevalente que suponen las enfermedades cardiovasculares.
- Si usted es un político o legislador, también esperamos que este viaje le ayude a realizar aportaciones significativas. El formato electrónico permite realizar actualizaciones continuas, por lo que le invitamos a que vuelva y a seguir leyendo en el futuro, no solo con el fin de repasar sino también para mantenerse al día.
- Tanto si es usted cardiólogo extra o intrahospitalario, residente de cardiología o estudiante de medicina, este volumen le resultará de VALOR INCALCULABLE en cada uno de los temas tratados.
Cardiología intervencionista para el diagnóstico de enfermedades y cirugía cardíaca para el tratamiento de afecciones
(LIBRO 6 DE LA SERIE DE LIBROS ELECTRÓNICOS SOBRE BIOMEDICINA)
Interventional Cardiology for Disease Diagnosis and
Cardiac Surgery for Condition Treatment
Disponible en Amazon.com desde el 24/12/2018
2018
https://www.amazon.com/dp/B07MKHDBHF
PART B: The eTOCs in Bi-lingual format:
Spanish and English in Text format
Serie A: libros electrónicos acerca de las enfermedades cardiovasculares
SEXTO VOLUMEN
Cardiología intervencionista para el diagnóstico de enfermedades y cirugía cardíaca para el tratamiento de afecciones
(LIBRO 6 DE LA SERIE DE LIBROS ELECTRÓNICOS SOBRE BIOMEDICINA)
Traducción a español Montero Language Services
Disponible en Amazon.com desde el 24/12/2018
2018
https://www.amazon.com/dp/B07MKHDBHF
Justin D. Pearlman, MD, PhD, FACC
Editorials and Clinical Pearls, Author
y
Leaders in Pharmaceutical Business Intelligence
avivalev-ari@alum.berkeley.edu
Redactora jefe
Series A: e-Books on Cardiovascular Diseases
VOLUME SIX
Interventional Cardiology for Disease Diagnosis and
Cardiac Surgery for Condition Treatment
(BIOMED E-BOOKS BOOK 6)
Available on Amazon.com since 12/24/2018
2018
https://www.amazon.com/dp/B07MKHDBHF
Justin D. Pearlman, MD, PhD, FACC
Editorials and Clinical Pearls, Author
and
Leaders in Pharmaceutical Business Intelligence
avivalev-ari@alum.berkeley.edu
Editor-in-Chief
Indice de contenidos electrónico (IDCe)
electronic Table of Contents
Los enlaces indicados llevan al contenido original en inglés
| MD | Licenciado/a en medicina y cirugía (Estados Unidos) |
| PhD | Doctorado/a |
| FCAP | Miembro distinguido del Colegio de anatomopatólogos de los Estados Unidos |
| FACC | Miembro distinguido del Colegio de cardiólogos de los Estados Unidos |
| RN | Enfermero/a titulado/a |
Listado de colaboradores
List of Contributors and Contributors’ Biographies
- Co-Editor, Series A Content Consultant, Author of Preface, Introduction and Summary to Part One and Part two, Epilogue, Author of Articles and Clinical Pearls:
Justin D. Pearlman MD ME PhD MA FACC
- Co-Editor, Author and Curator
Larry H Bernstein, MD, FCAP
- Co-Editor, Author and Curator, Editor-in-Chief, BioMed e-Series, 16 Volumes, Curator of Series A, Volumes 5 & Volume 6 electronic Table of Contents (eTOCs), Articles Curator and Lead Scientific Reporter
Aviva Lev-Ari, PhD, RN
ArticleID by Authors, Curators and Scientific Reporters
- 154 authored and curated articles
- 194 Scientific reports
In Total, 348 ArticleIDs
· Guest Authors & Live Link to Biographies: N = 9 articles
| Ed Kislauskis, PhD
N = 1 |
1.3.9 |
| Demet Sag, PhD. et al.
N = 3 |
6.1.1, 6.1.2, 6.1.3 |
| Stephen J. Williams, PhD
N = 1 |
6.2.2 |
| Aviral Vatsa, PhD, MBBS
N = 1 |
7.4.1 |
| Dror Nir, PhD
N = 1 |
8.1.2 |
| Tilda Barliya, PhD
N = 2 |
11.2.5, 14.4.1 |
· Lead Authors and Curators: N = 145 articles
· Lead Scientific Reporter: N = 194 articles
| Author & Curator:
Justin D. Pearlman, MD, PhD, FACC N = 3 |
4.1.2, 4.1.3, 8.1.1 | |
| Author and Curator:
Larry H Bernstein, MD, FCAP N = 32 |
1.1.1, 1.1.2, 1.1.3, 1.2.4, 1.3.3, 2.4, 3.2.1, 3.3.4.1, 3.3.5.4, 5.1.1, 5.1.2, 5.1.9, 5.2.1, 5.2.2, 5.2.5, 6.2.1, 6.2.4, 6.2.5, 6.2.11, 7.3.2, 9.1, 9.6.1, 9.6.2, 9.6.5, 10.3.2.1, 10.3.2.4, 12.4.2.5, 14.1.1, 14.1.2, 14.2.5, 14.2.7, 14.3.1 | |
| Curators:
Larry H. Bernstein, MD, FCAP and Aviva Lev-Ari, PhD, RN N = 35 |
1.2.3, 1.3.6, 3.3.5.1, 3.3.5.2, 3.3.5.3, 4.4.2, 6.2.8, 6.2.9, 7.2.3, 7.2.6, 9.4.1, 9.6.4, 9.6.6, 10.1.1, 10.1.6, 10.1,7, 10.1.8, 10.1.9, 10.1.11, 10.1.14, 10.2.1.3, 11.1.2, 11.1.3, 11.2.6, 12.3.1.2, 12.3.4.2, 12.3.4.3, 12.3.4.5, 12.4.1.1, 12.4.2.1, 13.2.12, 13.2.13, 13.4.1, 14.3.2, 14.3.5 | |
| Author:
Justin Pearlman, MD, PhD, FACC, Author and Curator: Larry H Bernstein, MD, FCAP, and Curator: Aviva Lev-Ari, PhD, RN N = 1 |
2.6 | |
| Curators:
Justin D. Pearlman, MD, PhD, FACC and Aviva Lev-Ari, PhD, RN N = 13
|
2.7, 4.1.4, 4.1.5, 8.4.2, 8.4.4, 8.4.5, 8.5.1, 8.5.2, 8.7.4, 8.8.1, 10.1.10, 11.1.7, 13.3.2 | |
| Co-Editor:
Larry H Bernstein, MD, FCAP, and Co-Editor: Justin Pearlman, MD, PhD, FACC N = 2 |
2.8, 7.2.2 | |
| Curators:
Aviva Lev-Ari, PhD, RN and Larry H. Bernstein, MD, FCAP N = 1 |
9.4.5 | |
| Authors:
Larry H Bernstein, MD, FCAP, Justin Pearlman, MD, PhD, FACC, and Curator: Aviva Lev-Ari, PhD, RN N = 2 |
3.3.5.5, 10.1.4 | |
| Aviva Lev-Ari, PhD, RN
Curations: N = 56 Scientific Reports: N = 194 ArticleIDs in Series A, Volume 6: N = 250 |
Curations
N = 56
1.3.2, 2.1, 3.1.1, 3.1.2, 3.1.3, 3.1.4, 3.2.4, 3.2.6, 3.3.2.8, 3.3.2.12, 3.3.2.13, 3.3.3.2, 3.3.4.2, 3.3.5.6, 4.1.6, 4.3.2, 5.1.3, 5.1.4, 5.1.5, 6.2.7, 7.1.1, 7.2.4, 8.1.3, 8.1.6, 8.1.17, 8.4.1, 8.6.5, 8.9.2, 9.4.9, 9.5.1, 10.1.3, 10.1.5, 10.2.2.1, 10.2.2.3, 10.2.2.5, 10.3.1.5, 11.1.1, 11.1.5, 11.1.6, 11.2.2, 11.2.3, 11.2.4, 11.2.7, 11.3.1, 11.3.7, 11.3.10, 11.3.11, 12.1, 12.3.1.1. 12.3.2.2, 12.3.2.3, 12.3.4.7, 12.4.1.3, 13.1.8, 13.3.5, 14.6.1 |
|
| Aviva
Lev-Ari, PhD, RN
Curations: N = 56
Scientific Reports: N = 194 ArticleIDs in Series A, Volume 6: N = 250 |
Scientific Reporting
N = 194 1.1.4, 1.2.1, 1.2.2, 1.3.1, 1.3.4, 1.3.5, 1.3.7, 1.3.8, 1.3.10, 2.2, 2.3, 2.5, 2.9, 2.10, 2.11, 3.1.5, 3.2.2, 3.2.3, 3.2.5, 3.3.1.1, 3.3.1.2, 3.3.1.3, 3.3.2.1, 3.3.2.2, 3.3.2.3, 3.3.2.4, 3.3.2.5, 3.3.2.6, 3.3.2.7, 3.3.2.9, 3.3.2.10, 3.3.2.11, 3.3.2.14, 3.3.3.1, 4.1.1, 4.1.7, 4.2.1, 4.2.2, 4.3.1, 4.4.1, 4.4.3, 5.1.6, 5.1.7, 5.1.8, 5.1.10, 5.1.11, 5.1.12, 5.1.13, 5.2.3, 5.2.4, 6.2.3, 6.2.6, 6.2.10, 6.3.1, 6.3.2, 6.3.3, 7.1.2, 7.1.3, 7.2.1, 7.2.5, 7.3.1, 8.1.4, 8.1.5, 8.1.7, 8.1.8, 8.1.9, 8.1.10, 8.1.11, 8.1.12, 8.1.13, 8.1.14, 8.1.15, 8.1.16, 8.2.1, 8.2.2, 8.2.3, 8.2.4, 8.2.5, 8.3.1, 8.3.2, 8.3.3, 8.3.4, 8.3.5, 8.3.6, 8.4.3, 8.4.6, 8.4.7, 8.6.1, 8.6.2, 8.6.3, 8.6.4, 8.7.1, 8.7.2, 8.7.3, 8.7.5, 8.9.1, 8.10.1, 8.11.1, 9.2, 9.3, 9.4.2, 9.4.3, 9.4.4, 9.4.6, 9.4.7, 9.4.8, 9.6.3, 10.1.2, 10.1.12, 10.1.13, 10.2.1.1, 10.2.1.2, 10.2.1.4, 10.2.2.2, 10.2.2.4, 10.2.2.6, 10.2.2.7, 10.3.1.2, 10.3.1.3, 10.3.1.4, 10.3.2.2, 10.3.2.3, 11.1.4, 11.1.8, 11.1.9, 11.1.10, 11.2.1, 11.2.8, 11.2.9, 11.2.10, 11.3.2, 11.3.3, 11.3.4, 11.3.5, 11.3.6, 11.3.8, 11.3.9, 12.2, 12.3.1.3, 12.3.1.4, 12.3.2.1, 12.3.3.1, 12.3.3.2, 12.3.4.1, 12.3.4.4, 12.3.4.6, 12.4.1.2, 12.4.2.2,12.4.2.3, 12.4.2.4, 12.4.2.6, 12.4.2.7, 12.4.2.8, 13.1.1, 13.1.2, 13.1.3, 13.1.4, 13.1.5, 13.1.6, 13.1.7, 13.1.9, 13.2.1, 13.2.2, 13.2.3, 13.2.4, 13.2.5, 13.2.6, 13.2.7, 13.2.8, 13.2.9, 13.2.10, 13.2.11, 13.2.14, 13.2.15, 13.2.16, 13.2.17, 13.2.18, 13.3.1, 13.3.3, 13.3.4, 13.3.6, 13.3.7, 13.5.1, 13.5.2, 13.6.1, 14.2.1, 14.2.2, 14.2.3, 14.2.4, 14.2.6, 14.3.3, 14.3.4, 14.5.1, 14.5.2 |
|
PREFACIO
por Justin D. Pearlman, MD, PhD, FACC
PREFACE
by Justin D. Pearlman, MD, PhD, FACC
El alcance de lo expuesto a continuación aborda la cardiología intervencionista y la cirugía cardíaca desde varias perspectivas, incluida la experiencia personal de pacientes e intervencionistas, además de los aspectos médicos, sociales y empresariales, incluidos los principales avances biotécnicos.
The scope of the following addresses interventional cardiology and cardiac surgery from many aspects, including the personal experience from patients and interventionalists, plus medical, societal and business aspects, including major biotechnical advances.
Introducción del libro por Justin D. Pearlman, MD, PhD, FACC
Book Introduction by Justin D. Pearlman, MD, PhD, FACC
Primera parte:
Tendencias en cardiología intervencionista y cirugía cardíaca
Part One:
Trends in Intervention Cardiology and Cardiac Surgery
Introducción por Justin D. Pearlman, MD, PhD, FACC
Introduction by Justin D. Pearlman, MD, PhD, FACC
Análisis de las contribuciones al conocimiento de vanguardia por parte de instituciones y particulares, personalizando el recorrido por las capacidades actuales y señalando el camino hacia nuevos avances. También se tratan los aspectos empresariales y la FDA.
A review of contributions to the current state of the art from institutions and individuals personalizes a tour of the current capabilities and points to avenues for further advances. Business aspects and FDA are also covered.
Capítulo 1: Lecciones del pasado. Reconocimiento a los pioneros que contribuyeron al estudio del corazón humano
Chapter 1: Lessons from the Past – Recognition of Pioneering Contributors to the Study of the Human Heart
Capítulo 2: Atención sanitaria cardiovascular: valor y carga económica
Chapter 2: Cardiovascular Healthcare: Value and Cost Burden
Capítulo 3: Ensayos clínicos y aprobación de productos sanitarios por la FDA
Chapter 3: Clinical Trials and FDA Approval of Medical Devices
Resumen por Justin D. Pearlman, MD, PhD, FACC
Summary by Justin D. Pearlman, MD, PhD, FACC
Los puntos clave de lo anterior son: compartir el impacto personal de tener o tratar una afección cardiovascular potencialmente letal; la importancia vital de las innovaciones para poder cambiar los resultados, y los retos y adversidades que afrontan tanto el paciente como el cuidador y los innovadores médicos. Se realizó un análisis de la carga que suponen las enfermedades cardiovasculares, y de las oportunidades, obstáculos y protecciones que hay en el camino hacia la difusión de soluciones.
Take home messages from the above include sharing the personal impact of having or treating a life-threatening cardiovascular condition, the vital importance of innovations to change the outcomes, and the trials and tribulations of both the patient, the caretaker, and the medical innovators. The burden of cardiovascular disease was reviewed, as well as the opportunities, hurdles and protections in the path of disseminating solutions.
Segunda parte:
Enfermedades cardiovasculares. Etiología,
diagnóstico y opciones de tratamiento
Part Two:
Cardiovascular Diseases – Etiology,
Diagnostics and Treatment Options
Introducción por Justin D. Pearlman, MD, PhD, FACC
Introduction by Justin D. Pearlman, MD, PhD, FACC
Los siguientes capítulos se centran en las causas y los mecanismos de las enfermedades cardiovasculares, información que resulta crucial para identificar las oportunidades de prevención y mejora. La comprensión de los fundamentos genéticos (las plantillas de todas las proteínas implicadas) no solo clarifica el ajuste fino de la regulación por biorretroalimentación sino que también aporta “biomarcadores” (análisis de sangre) que aclaran el estado del paciente y su respuesta a los tratamientos. El proceso de gestión del contenido (un recorrido guiado por expertos con vínculos a las fuentes originales) se ha centrado particularmente en tres aspectos fundamentales: la enfermedad coronaria, los coágulos sanguíneos y la insuficiencia cardíaca. Los temas tratados son:
The following chapters focus on the causes and mechanisms of cardiovascular diseases, information crucial to identifying opportunities for prevention and amelioration. Understanding the genetic underpinnings (the templates for all proteins involved) not only clarifies the fine-tuning of biofeedback regulation, but also provides “biomarkers” (blood tests) that clarify patient status and responses to treatments. Three large topics – coronary disease, blood clots, and heart failure, receive particular attention by the process of curation (expert guided tour linked to original source materials). The topics covered are:
I. Enfermedades cardiovasculares: etiología
I. Cardiovascular Diseases – Etiology
Capítulo 4: Arteriopatía coronaria e intervenciones coronarias
Chapter 4: Coronary Arteries Disease and Interventions
Capítulo 5: Genómica y biomarcadores de las enfermedades cardiovasculares
Chapter 5: Genomics and Biomarkers of Cardiovascular Diseases
Capítulo 6: Circulación, coagulación y trombosis
Chapter 6: Circulation, Coagulation and Thrombosis
Capítulo 7: Insuficiencia ventricular: dispositivos de asistencia quirúrgicos y no quirúrgicos
Chapter 7: Ventricular Failure: Assist Devices, Surgical and Non-Surgical
II. Enfermedades cardiovasculares: diagnóstico de episodios cardíacos urgentes
II. Cardiovascular Diseases – Diagnostics for Emergent Cardiac Events
Capítulo 8: Imágenes cardíacas y principales modalidades del diagnóstico cardiovascular
Chapter 8: Cardiac Imaging and Cardinal Modalities of Cardiovascular Diagnostics
Capítulo 9: Episodios cardíacos urgentes
Chapter 9: Emergent Cardiac Events
III. Enfermedades cardiovasculares: diagnóstico y tratamiento de los trastornos cardiovasculares crónicos
III. Cardiovascular Diseases – Diagnostics and Management of Chronic Cardiovascular Disorders
Capítulo 10: Trastornos cardiovasculares crónicos
Chapter 10: Chronic Cardiovascular Disorders
IV. Enfermedades cardiovasculares: opciones de tratamiento
IV. Cardiovascular Diseases – Treatment Options
Capítulo 11: Comparación de la cirugía de revascularización coronaria (CRC) con la intervención coronaria percutánea (ICP) o angioplastia coronaria
Chapter 11: Comparison of Coronary Artery Bypass Graft (CABG) and Percutaneous Coronary Intervention (PCI) / Coronary Angioplasty
Capítulo 12: Tecnologías para mantener la circulación: ensanchamiento de una arteria estrechada mediante stents y armazones
Chapter 12: Technologies to sustain Circulation: Enlargement of a Narrowing Artery by Stenting and Scaffolding
Capítulo 13: Reemplazo, implante y reparación valvular
Chapter 13: Valve Replacement, Valve Implantation and Valve Repair
Capítulo 14: Modificación de la anatomía original del corazón: revolución en las tecnologías y métodos
Chapter 14: Modification of Heart Original Anatomy – Revolution in Technologies and Methods
Resumen por Justin D. Pearlman, MD, PhD, FACC
Summary by Justin D. Pearlman, MD, PhD, FACC
EPÍLOGO POR Justin D. Pearlman, MD, PhD, FACC
EPILOGUE by Justin D. Pearlman, MD, PhD, FACC
Gracias por acompañarnos en este viaje a través de las numerosas facetas de las enfermedades cardiovasculares y sus repercusiones. Si es o se convierte usted en un paciente o defensor del paciente, se enfrentará a decisiones importantes. Esperamos que la presentación del conocimiento de vanguardia sobre las diferentes opciones a su alcance le ayude a tomar la mejor decisión en cada momento.
Thank you for joining us on a journey through the numerous facets of cardiovascular disease and its impact. If you are or become a patient, or a patient advocate, you will face important decisions. We hope the presentation of the state of the art in competing options will help you make the best decision at the time.
- Si es usted un innovador, esperamos que la presentación mediante ejemplos, además de los aspectos comerciales y normativos, le ayude a seguir contribuyendo a la mejora del manejo de la carga prevalente que suponen las enfermedades cardiovasculares.
- If you are an innovator, we hope the presentation by examples plus business and regulation aspects helps you contribute further improvements to the management of the prevalent burden of cardiovascular diseases.
- Si usted es un político o legislador, también esperamos que este viaje le ayude a realizar aportaciones significativas. El formato electrónico permite realizar actualizaciones continuas, por lo que le invitamos a que vuelva y a seguir leyendo en el futuro, no solo con el fin de repasar sino también para mantenerse al día.
- If you are a politician or policy maker, we likewise hope this journey helps you form significant contributions. The electronic format enables continual updates, so come back and read more in the future, not just for review, but to keep up to date.
- Tanto si es usted cardiólogo extra o intrahospitalario, residente de cardiología o estudiante de medicina, este volumen le resultará de VALOR INCALCULABLE en cada uno de los temas tratados.
- If you are a Cardiologist in the Community or a Fellow in Cardiology, a Resident in Cardiology or a medical student – for you this volume is INVALUABLE on every topic that it covers.
Cardiología intervencionista para el diagnóstico de enfermedades y cirugía cardíaca para el tratamiento de afecciones
(LIBRO 6 DE LA SERIE DE LIBROS ELECTRÓNICOS SOBRE BIOMEDICINA)
Interventional Cardiology for Disease Diagnosis and
Cardiac Surgery for Condition Treatment
Disponible en Amazon.com desde el 24/12/2018
2018
https://www.amazon.com/dp/B07MKHDBHF
PART C: The Editorials of the original e-Books in
English in Audio format
The Voice of Aviva Lev-Ari, PhD, RN
- Editor-in-Chief, BioMed e-Series, 2013-2021 and
- Editor-in-Chief, NEW GENRE BioMed e-Series Edition, Spanish Audio, Bilingual English-Spanish Text and English Audio, 2022
Interventional Cardiology for Disease Diagnosis and
Cardiac Surgery for Condition Treatment
This is Volume Six in Series A: Cardiovascular Diseases. It consists of 154 authored and curated articles and 194 Scientific reports, in Total, 348 articleIDs are included in the electronic Table of Contents (eTOCs).
This is PART C of Volume Six in the NEW GENRE Edition: The Editorials of the original e-Books in English in Audio format.
In addition to the Editorials, we selected to feature a selection of the articles included in the original e-Book published in 2018. The original articleIDs are maintained to assist the e-Reader that will be stimulated by the Audio Editorials and will decide to read selectively articles in the original volume.
PREFACE by Justin D. Pearlman MD ME PhD MA FACC
Volume Six addresses Interventional Cardiology, Cardiac Imaging and Cardiac Surgery.
In lay terms, all patient interactions might be considered interventions, but in medicine, that term is reserved for procedures that directly produce physical changes. Surgical interventions for cardiovascular diseases include heart or heart and lung transplant, implantation of cardiac assist devices, shock devices and pacemakers, bypass grafts for coronary or other arteries, valve repairs or replacement, removal of plaque (endarterectomy), removal of tumors, and repair or palliation of injuries or of congenital anomalies. All of these interventions are continually studied and improved, with a major effort at minimizing the risk, reducing recovery time and reducing the size of entry scar, for example by use of video scopes instead of direct visualization, and mechanical devices and robotics instead of direct manual access. Interventional Cardiology refers to an often competing, non-surgical approach in which access is limited to entry by vein or artery (catheterization). The two teams have joined forces to achieve a major success in replacing aortic valves by femoral artery access without opening the chest at all (TAVR), with on-going progress towards a similar approach to mitral valve replacement.
Book Introduction by Justin D. Pearlman MD ME PhD MA FACC
Volume Six: Interventional Cardiology and Cardiac Surgery for Disease Diagnosis and Guidance of Treatment addresses disease prevalence, personalized patient and doctor experiences with Cardiac Surgery, the role of transfusion, status of the MedTech market, and a review of major accomplishments from pathology, anesthesiology, radiology, cardiology and surgery. The contributions of specific groups, such as the Texas Heart Institute, the Dalio Institute at New York Presbyterian/Weill Cornell, the Cleveland Clinic, and the Scripps Institute are reviewed. Individual contributions from Eric Topol, Arthur Moss, Paul Zoll, Tim Wu, and Earl E. Bakken (Medtronic co-founder) are included. Discoveries in relevant biology, including ATP (the metabolic paycheck) and plasma metabolomics, and novel technologies such as tethered-liquid perfluorocabon surface biocoating to prevent clotting are further subjects of curation. Additional curations present views of cardiothoracic surgeons, of cath lab “jockeys”, and engineering of replacement body parts. An aside presents poetic views expressed in a discussion between Dr. John M. Mandrola and Dr. Abraham Verghese. Business aspects are addressed by review of costs, prevalence, payment methods, prevention impact and business models. Decision support tools are also reviewed, and changes in guidelines.
Overall, there were 2.2 million hospitalizations nationwide for cardiovascular events in 2016, resulting in $32.7 billion in costs and 415,480 deaths.
Data from sources including Healthcare Cost and Utilization Project databases and the National Vital Statistics System show that as many as 805,000 of the 2016 hospitalizations and 75,245 deaths occurred among adults under age 65 years.
“Many of these cardiovascular events are happening to middle-aged adults — who we wouldn’t normally consider to be at risk,” Schuchat said. “Most of these events can be prevented through daily actions to help lower risk and better manage medical conditions.”
The highest morality rates were seen among non-Hispanic blacks (211.6 per 100,000), and men had the highest hospitalization rates (989.6 per 100,000), with mortality rates of 172.3 per 100,000, and the rates increased with age.
The study also provides state-level data on nonfatal cardiovascular events — and showed surprisingly substantial variations in numerous measures: Rates of emergency department visits for cardiovascular events in 2016, for instance, per 100,000, ranged from 56.4 in Connecticut to as high as 274.8 in Kentucky; hospitalizations, per 100,000, ranged from 484.0 in Wyoming to 1670.3 in Washington, DC; and mortality, per 100,000, ranged from 11.2 in Vermont to 267.3 in Mississippi.
“This is one of the first studies to demonstrate striking state-level variation in nonfatal cardiovascular event rates and hospitalization costs using data collected among adults of all ages and across all payer types, including the uninsured,” the authors said.
SOURCE
Cardiovascular Event Rates High in Middle Age: CDC by Nancy A. Melville, September 11, 2018
We start this book by sharing with the e-Reader three case studies on Cardiac Patient experience with Open Heart Surgery
The Voice of Open Heart Surgery Survivors
- A Patient’s Perspective: On Open Heart Surgery from Diagnosis and Intervention to Recovery – A New Day, a New Lease and Unfolding Questions!
- Triple-bypass operation at age 69 – Ralph’s Story: An Entertainer at Heart
- A Fantastic Vessel-Clearing Innovation on The vessel-clearing device, U.S. Patent No. 8,663,209
These three articles are in Chapter 8: Cardiac Surgery, in
The VOICES of Patients, Hospitals CEOs, Health Care Providers, Caregivers and Families: Personal Experience with Critical Care and Invasive Medical Procedures, 2017. On Amazon.com since 10/16/2017
https://www.amazon.com/dp/B076HGB6MZ
We proceed by sharing with the e-Reader the expertise our members of the Team has in Cardiovascular Diseases and all the other aspects of Medicine that are dealing with co-morbidities causing cardiac maladaptations and dysfunctions. We express that expertise by a series of commentaries created to highlight the frontiers of Cardiology and of biological sciences as we have organized in a Series of 18 volumes in BioMedicine. Our focus is to demonstrate how each of the books is contributing to the education of Patients and of medical stuff is the complexities of cardiovascular diseases. We demonstrate and analyze the context in which the Cardiovascular and Cardiac fields had been developed and what are the breakthrough innovations emerging in these interrelated fields.
Please start by reviewing the following articles for broader edification with our approach to this e-Book subject matter:
· Commentaries on each Volume’s Contribution to Medical Education by L.H. Bernstein, MD, FCAP and Aviva Lev-Ari, PhD, RN – BioMedical e-Books e-Series: Multiple Volumes in Five e-Series
Authors: Larry H. Bernstein, MD, FCAP and Aviva Lev-Ari, PhD, RN
· An Overview of the Heart Surgery Specialty: heart transplant, lung transplant, heart-lung transplantation, aortic valve surgery, bypass surgery, minimally invasive cardiac surgery, heart valve surgery, removal of cardiac tumors, reoperation valve surgery
Reporter: Aviva Lev-Ari, PhD, RN
· No evidence to change current transfusion practices for adults undergoing complex cardiac surgery: RECESS evaluated 1,098 cardiac surgery patients received red blood cell units stored for short or long periods
Reporter: Aviva Lev-Ari, PhD, RN
Example of novel technologies
Tethered–Liquid Perfluorocarbon surface (TLP): Biocoating Prevents Blood from Clotting on Implantables
Reporter: Aviva Lev-Ari, PhD, RN
MIT’s Promise for the MI Patient: A new cardiac patch uses Gold Nanowires to enhance Electrical Signaling between heart cells
Curator: Aviva Lev-Ari, PhD, RN
Claimers:
- Some articles mentioned above as Repository of Sources, received an articleID and were sorted among the various Chapters in the e-Book since they provide a unique perspective and context for the content of the e-Book itself.
- One articles, 3.3.2.8 is identical to 10.2.2.5. In Chapter 3, this article represents a case for the process that a Medical Device is subjected to for being granted FDA Clearance. In Chapter 10, this article represents a technology used to treat refractory hypertension and the function of the cardiac-renal axis play in treatment for this condition by renal denervation.
- All Videos references in this e-Book are courtesy of Youtube.com
- Cardiac Imaging for diagnosis is a large part of this e-Book. We acknowledge the expertise of e-Book Co-Editor, Justin D. Pearlman MD ME PhD MA FACC in Cardiac Imaging.
- This is the only e-Book in existence that covers in depth Cardiac Surgery, Interventional Cardiology and Cardiac Imaging. These three practitioners are affiliated to three different professional societies.
- This is the only e-Book in existence that covers in depth Cardiac Repair Medical Devices and Cardiac Surgery, Interventional Cardiology and Cardiac Imaging in ONE volume.
- We decided to include in addition to all modalities of Cardiac Repair also Vascular Repair, which represents a fourth surgical specialty using endo-vascular interventions and stent insertion in the systemic vasculature of the Brain, Head and Neck and the entire human body (Abdomen and Extremities), excluding the Heart which is under the care of Cardiac Surgeons (Cardio-thoracic Surgery Specialty) and Interventional Cardiologists. Interventional Radiologists deal with the systemic vasculature and work in tandem with Vascular surgeons.
The VOICE of Dr. Pearlman is presented in ITALICS
PREFACE
by Justin D. Pearlman MD ME PhD MA FACC
Trends in interventional cardiology and cardiac surgery presents a curation, or guided tour, of original updates on the state of the art and the pathways linking past-present-future for structural changes by catheter or knife to address cardiovascular impairments. It begins with a personal touch, heart-felt views from patient and doctor. That is followed by a tour through major contributions from centers and individuals. Many of the solutions involve devices, so a survey of companies, products, market share, and company focuses is covered, as well as clinical trial and FDA approval issues. Opportunities are addressed by presenting updates on the mechanisms of disease, intervention, and response monitoring, along with innovations and discoveries pointing a path for the future.
Part One
Trends in Intervention Cardiology and Cardiac Surgery
Introduction
Justin D. Pearlman MD ME PhD MA FACC
Atul Gawande authored “Complications: A Surgeon’s Notes on an Imperfect Science” as he completed his residency in cardiothoracic surgery. It presents a lively, prescient and candid first hand experience, trials and tribulations, in the cardiothoracic surgeon’s view of patient care. Dick Cheney co-authored with Jonathan Reiner M.D. Heart: An American Medical Odyssey, which reviews his struggles with multiple heart attacks and near death experiences from heart failure, treated with an assist device and then transplantation. These two perspectives personalize major issues extant in Cardiology, and lay a strong foundation for delving deeply into the state of the art which is covered subsequently by curation of numerous relevant topics from individual and institutional contributions, ground breaking discoveries and advances.
Dick Cheney, the former vice president, had the first of five heart attacks in 1978, when he was 37 years old and running in his first political campaign, to become a Republican in the House of Representatives in Wyoming. As consequences of multiple heart attacks, he became pacemaker dependent and then mechanical assist device dependent. He lived with the fear that enemies of the state might try to use RF reprogramming to kill him by reprogramming his pacemaker, so he had his doctors disable that feature. In 2010 the former vice president was within hours of dying from heart failure <http://www.usatoday.com/story/news/politics/2013/10/20/cheney-head–and-heart-strong/3107049/#>, when he was saved by urgent surgery to implant a left ventricular assist device with an external battery that kept him alive while he waited for a heart transplant. He received the call that he reached the top of the recipient list and a donor heart available for him 20 months later. “As I think about the future, I’m back where most people live their lives,” he told USA TODAY in an extended interview about Heart: An American Medical Odyssey, a new book he co-authored with cardiologist Jonathan Reiner. “Which is death is not imminent, and that’s different.”
A selective Selection of articles from the Original e-Book
are presented below, some had been selected to be featured because of the Editorials written about them and the others because they are of salient importance to the discipline.
Aviva Lev-Ari, PhD, RN
Chapter 1: Lessons from the Past – Recognition of Pioneering Contributors to the Study of the Human Heart
1.1 In Service by the Cardiology Profession
1.1.1 Outstanding Achievement in Pathology
Curator: Larry H Bernstein, MD, FCAP
The Olympus microscope company created an award for unsung heroes in pathology. Dr. Tracey Corey Handy was recognized for her contributions as medical examiner for child abuse, by probing deeply into causes of child mortality, adding routine screening for metabolic defects apparent in conditions otherwise attributed to Sudden Infant Death Syndrome (SIDS). Dr. Matthew Zarka was recognized for his OB/GYN outreach work on behalf of extremely poor Mexican-Indian population in the remote mountain regions of Oaxaca, Mexico. The contributions of Steven L. Gonias, M.D., Ph.D. apply to the heart in the more direct sense for identifying and characterizing novel pathways of proteases and their cell-surface receptors. The laboratory of David A. Herold, M.D., Ph.D. improved mass spectrometry applications to clinical diagnostics, including for prostaglandins, trace metal and steroids, in particular testosterone. The laboratory of David Cheresh Ph.D. has identified a series of critical microRNAs that regulate the growth of blood vessels (angiogenesis).
1.1.2 Outstanding Achievement in Anesthesiology
Curator: Larry H Bernstein, MD, FCAP
Dr. Arthur Bert is a cardiac anesthesiologist for children and adults who participated in a research team growing tissue-engineered heart valves. Dr. Henrik Kehlet, M.D., Ph.D. was recognized for advances in pain prevention (pre-emptive analgesia) and speedy recovery from surgery (fast track enhanced recovery after surgery).
1.1.3 Outstanding Achievements in Radiology or Radiotherapy
Curator: Larry H Bernstein, MD, FCAP
Radiation oncologists Dr. Lawrence Marks, Julian Rosenman and Joel Tepper are among 22 UNC-affiliated oncologists honored by Newsweek magazine. Dr. Timothy Zagar received ASTRO research award for assessing risk benefit of radiation versus alternative therapies. John C. Baumann, M.D. was honored for his quality rating as the chief of radiation oncology at the Walter Reed Medical Center.
1.1.4 American College of Cardiology 2015 Annual Meeting: Simon Dack Lecture: “I Carry Your Heart” by Abraham Verghese, MD
Reporter: Aviva Lev-Ari, PhD, RN
Dr. Abraham Verghese introduced a session of the American College of Cardiology (ACC) Scientific Sessions with an E.E Cumings poem about heart: “I Carry Your Heart with Me,” which focuses on the power and unity of love, and how love connects not just two individuals but also the world at large.
1.2.1 Texas Heart Institute: 50 Years of Accomplishments
Reporter: Aviva Lev-Ari, PhD, RN
The Texas Heart Institute has passed its 50-year milestone, having performed more than 100,000 open heart operations, 200,000 cardiac catheterizations, and 1,000 heart transplants, with 20 consecutive years ranked as one of the top 10 heart centers in America (“America’s Best Hospitals,” U.S. News & World Report). This curation reviews its structure, history, and accomplishments.
1.2.2 Dalio Institute of Cardiovascular Imaging @ NewYork-Presbyterian Hospital and Weill Cornell Medical College
Reporter: Aviva Lev-Ari, PhD, RN
The Dalio Institute for Cardiovascular Imaging, a joint venture from New York-Presbyterian Hospital and Weill Cornell Medicine, has focused on improvements in cardiac imaging and risk assessment, including a focus on vulnerable plaque. Vulnerable plaque is a major as yet unsolved issue due to the observation that while half of heart attacks occur as consequences of observable and stress test detectable blockages or “significant stenosis,” the other half of patients who had recent prior coronary imaging did not have flow limiting blockages, but rather had lesions minor in degree of obstruction that proved major in their consequences. Thus, prevention for that category needs to identify and remedy “unstable plaque,” consisting of lesions that are not currently severe but are prone to fracture, plaque hemorrhage, and thrombogenesis, as causes of heart attacks.
1.2.3 ATP – the universal energy carrier in the living cell: Reflections on the discoveries and applications in Medicine
Curators: Larry H. Bernstein, MD, FCAP and Aviva Lev-Ari, PhD, RN
This curation tracks the discoveries that identified and elucidated the roles of ATP as the biologic paycheck for energizing cell activities, including enabling the beating of the heart.
1.2.4 A Future for Plasma Metabolomics in Cardiovascular Disease Assessment
Curator: Larry H Bernstein, MD, FCAP
In a search for early markers of heart attacks, peripheral plasma from Non ST Segment Elevation Acute Coronary Syndrome patients and healthy controls were analyzed by gas chromatography – mass spectrometry which identified 15 metabolites with statistical differences (p<0.05) between experimental groups.
1.3 Leadership in Cardiology and in Design of Medical Devices
1.3.1 For Accomplishments in Cardiology and Cardiovascular Diseases: 2015 The Arrigo Recordati International Prize for Scientific Research
Reporter: Aviva Lev-Ari, PhD, RN
The Arrigo Recordati International Prize for Scientific Research (in memory of the Italian pharmaceutical entrepreneur) awarded 100,000 Euros to Professor John Joseph Valentine McMurray of Glasgow, Scotland, UK and Professor Salim Yusuf, of Hamilton, Canada for their contributions to population research into cardiovascular risk reduction.
Chapter 2: Cardiovascular Healthcare: Value and Cost Burden
2.9 CT Angiography (CCTA) Reduced Medical Resource Utilization compared to Standard Care reported in JACC
Minimally invasive x-ray imaging of coronary artery disease (computed tomography instead of arterial catheterization cinefluoroscopy) provides lower quality images at similar or higher radiation and similar or higher contrast agent load without the opportunity for concurrent intervention. However, it does provide 3D data, does not require arterial catheterization with risks of vessel damage, is faster and easier, and there is progress reducing the radiation hazard. Recent advances add the ability to analyze intensity versus time to get prefusion data analogous to “flow reserve.”
Chapter 3: Clinical Trials and FDA Approval of Medical Devices
3.2 USPTO – Issues in Patenting Innovations
3.2.1 USPTO Guidance On Patentable Subject Matter
Curator and Reporter: Larry H Bernstein, MD, FCAP
https://pharmaceuticalintelligence.com/2014/07/03/uspto-guidance-on-patentable-subject-matter/
3.2.2 Patent Dispute over Heart Defect Repair Technology: Appeals court Upholds Gore win over St. Jude Medical – Helex septal occluder competes with the Amplatzer device made by AGA/St. Jude
Reporter: Aviva Lev-Ari, PhD, RN
3.2.3 CardioMEMS sold to St. Jude Medical: Boston Millennia Partners announced that St. Jude Medical (NYSE: STJ) is acquiring the remaining 81 percent of CardioMEMS, Inc. it does not own for $375 million
Reporter: Aviva Lev-Ari, PhD, RN
3.2.4 Transcatheter Valve Competition in the United States: Medtronic CoreValve infringes on Edwards Lifesciences Corp. Transcatheter Device Patents
Curator: Aviva Lev-Ari, PhD, RN
3.2.5 Settled Heart Valve Lawsuit: Medtronic to Pay Edwards: Edwards Lifesciences’ Sapien XT beat out Medtronic’s CoreValve
Reporter: Aviva Lev-Ari, PhD, RN
3.2.6 Spectranetics, a Technology Leader in Medical Devices for Coronary Intervention, Peripheral Intervention, Lead Management to be acquired by Philips for 1.9 Billion Euros
Reporter and Curator: Aviva Lev-Ari, PhD, RN
3.3 FDA – Issues in Clinical Trials and Approval of Medical Devices
3.3.1 Policy Issues
3.3.1.1 FDA on Medical Devices: Part 1 – User Fee Act (MDUFA) III and Part 2 – Expedited Access Program for Medical Devices that Address Unmet Medical Needs
Reporter: Aviva Lev-Ari, PhD, RN
3.3.1.2 Boston Scientific implant designed to occlude the heart’s left atrial appendage implicated with embolization – Device Sales in Europe halts
Reporter: Aviva Lev-Ari, PhD, RN
3.3.1.3 Steps to minimise replacement of cardiac implantable electronic devices
Reporter: Aviva Lev-Ari, PhD, RN
3.3.2 Medical Devices: The 510(k) Clearance Process
3.3.2.1 Gaps, Tensions, and Conflicts in the FDA Approval Process: Implications for Clinical Practice
Reporter: Aviva Lev-Ari, PhD, RN
3.3.2.2 Expanded Stroke Thrombectomy Guidelines: FDA expands treatment window for use (Up to 24 Hours Post-Stroke) of clot retrieval devices (Stryker’s Trevo Stent) in certain stroke patients
Reporter: Aviva Lev-Ari, PhD, RN
3.3.2.3 Medical Devices Early Feasibility FDA’s Pathway – Accelerated Recruitment for Randomized Clinical Trials: Replacement and Repair of Mitral Valves
Reporter: Aviva Lev-Ari, PhD, RN
3.3.2.4 Clinical Trials for Feasibility FDA’s Pathway Annulus Repairs and TAVR: CT Structural Software for Procedural Planning and Anatomical Assessments
Reporter: Aviva Lev-Ari, PhD, RN
3.3.2.5 Abbott’s Bioabsorbable Stent met its Primary Endpoint in a U.S. Clinical Trial, applications for FDA Approval follows
Reporter: Aviva Lev-Ari, PhD, RN
3.3.2.6 New Era for PAD as FDA approval in the US of 1st Drug-coated Balloon (DCB) for PDA – CAD Indication for DCB will follow
Reporter: Aviva Lev-Ari, PhD, RN
3.3.2.7 An FDA advisory committee unanimously recommended approval of the Lutonix drug-coated balloon PTA catheter for the treatment of patients with femoropopliteal occlusive disease.
Reporter: Aviva Lev-Ari, PhD, RN
3.3.2.8 Market Impact on Global Suppliers of Renal Denervation Systems by Pivotal US Trial: Metronics’ Symplicity Renal Denervation System FAILURE at Efficacy Endpoint
Curator and Reporter: Aviva Lev-Ari, PhD, RN
3.3.2.9 Hybrid Cath Lab/OR Suite’s da Vinci Surgical Robot of Intuitive Surgical gets FDA Warning Letter on Robot Track Record
Reporter: Aviva Lev-Ari, PhD, RN
3.3.2.10 Clinical Trials on transcatheter aortic valve replacement (TAVR) to be conducted by American College of Cardiology and the Society of Thoracic Surgeons
Reporter: Aviva Lev-Ari, PhD, RN
3.3.2.11 FDA Approval for Under-Skin Defibrillator goes to Boston Scientific Corporation
Reporter: Aviva Lev-Ari, PhD, RN
3.3.2.12 FDA Pending 510(k) for The Latest Cardiovascular Imaging Technology
Curator: Aviva Lev-Ari, PhD, RN
3.3.2.13 Minimally Invasive Structural CVD Repairs: FDA grants 510(k) Clearance to Philips’ EchoNavigator – X-ray and 3-D Ultrasound Image Fused.
Curator: Aviva Lev-Ari, PhD, RN
3.3.2.14 FDA: Strengthening Our National System for Medical Device Post-market Surveillance
Reporter: Aviva Lev-Ari, PhD, RN
3.3 FDA – Issues in Clinical Trials and Approval of Medical Devices
3.3.3 Transcatheter Aortic Valve Replacement (TAVR)
3.3.3.1 Transcatheter Aortic Valve Implantation (TAVI): FDA approves expanded indication for two transcatheter heart valves for patients at intermediate risk for death or complications associated with open-heart surgery
Reporter: Aviva Lev-Ari, PhD, RN
3.3.3.2 Clinical Trials on Transcatheter Aortic Valve Replacement (TAVR) to be conducted by American College of Cardiology and the Society of Thoracic Surgeons
Curator: Aviva Lev-Ari, PhD, RN
3.3.5 From Lab to Bedside: Translational, Post-Translational and Regenerative Medicine in Cardiology
3.3.5.1 Introduction to Translational Medicine (TM) – Part 1: Translational Medicine
Author and Curator: Larry H Bernstein, MD, FCAP and Curator: Aviva Lev-Ari, PhD, RN
https://pharmaceuticalintelligence.com/2014/04/25/introduction-to-translational-medicine-tm-part-1/
3.3.5.2 Summary of Translational Medicine – e-Series A: Cardiovascular Diseases, Volume Four – Part 1
Author and Curator: Larry H Bernstein, MD, FCAP and Curator: Aviva Lev-Ari, PhD, RN
3.3.5.3 Introduction to e-Series A: Cardiovascular Diseases, Volume Four Part 2: Regenerative Medicine
Author and Curator: Larry H Bernstein, MD, FCAP and Curator: Aviva Lev-Ari, PhD, RN
3.3.5.4 Summary – Volume 4, Part 2: Regenerative Medicine in Cardiovascular Diseases
Author and Curator: Larry H Bernstein, MD, FCAP
3.3.5.5 Epilogue: Volume 4 – Translational, Post-Translational and Regenerative Medicine in Cardiology
Larry H Bernstein, MD, FCAP, Author and Curator, Content Consultant for Series B,C,D,E
Justin Pearlman, MD, PhD, FACC, Author and Curator, Content Consultant for Series A: Cardiovascular Diseases
Aviva Lev-Ari, PhD, RN, Co-Editor and Editor-in-Chief, BioMed e-Series
3.3.5.6 Stem Cells and Cardiac Repair: Scientific Reporting by Aviva Lev-Ari, PhD, RN
Curator: Aviva Lev-Ari, PhD, RN
Summary to Part One:
by Justin D. Pearlman MD ME PhD MA FACC
Curated updates in cardiovascular disease and interventions by catheter or knife presented expert guided tours of literature addressing current treatments, new treatments available only at specialized centers, and pathways to upcoming improvements. The use of stem cells to repair previously permanent injuries from heart attacks is a particularly exciting arena. Reduced risk and recovery time by catheter-based aortic valve replacement is becoming a mainstream offering, initially for just patients who were deemed excessive risk for open surgery, but now becoming a desired alternative for patients not requiring concurrent surgery, e.g., for coronary artery bypasses (CABG). Trans-catheter repair of mitral regurgitation (MITRA) on the other hand has so far been less compelling due to less than stellar outcomes. The materials presented include companies, market shares, FDA and trial hurdles, and opportunities. The electronic format enables periodic updates, so return here not only to review, but to track progress and guides to further opportunities.
Part Two
Cardiovascular Diseases – Etiology,
Diagnostics and Treatment Options
Introduction
Justin D. Pearlman MD ME PhD MA FACC
Curation of the topics addressing causes, diagnoses and treatment options starts with the cause of heart attacks – arterial plaques, and also covers hypertension, the two most common causes of heart failure. Subtopics include medication versus catheter intervention, endovascular intervention, tissue engineering, genomics and gene therapies. The understanding of disease mechanisms, treatments and opportunities to define status and response to interventions continuously evolves. Wise investment, further innovation, and decision-making benefits from a mastery of every level of the curated data presented.
Chapter 4: Coronary Arteries Disease (CAD) and Interventions
4.1 Thought Leadership on CAD
4.1.1. 2017 World Medical Innovation Forum: Cardiovascular, May 1-3, 2017, Partners HealthCare, Boston, at the Westin Hotel, Boston
Reporter: Aviva Lev-Ari, PhD, RN
4.1.2 Unstable Arterial Plaques
Curator & Author: Justin D Pearlman, MD, PhD, FACC
https://pharmaceuticalintelligence.com/2014/06/08/unstable-arterial-plaques/
4.1.3 Coronary Artery Interventions: balloon, stent, drug-eluting and antiplatelet demand
Curator: Justin D Pearlman, MD, PhD, FACC
4.1.4 State of Cardiology on Wall Stress, Ventricular Workload and Myocardial Contractile Reserve: Aspects of Translational Medicine (TM)
Curators: Justin D. Pearlman, MD, PhD, FACC and Aviva Lev-Ari, PhD, RN
4.1.5 Hypertension and Vascular Compliance: 2013 Thought Frontier – An Arterial Elasticity Focus
Curators: Justin D. Pearlman, MD, PhD, FACC and Aviva Lev-Ari, PhD, RN
4.1.6 Coronary artery disease in symptomatic patients referred for coronary angiography: Predicted by Serum Protein Profiles
Curator: Aviva Lev-Ari, PhD, RN
4.2 Drug Therapy vs Angioplasty
4.2.1 Ischemic Stable CAD: Medical Therapy and PCI no difference in End Point: Meta-Analysis of Contemporary Randomized Clinical Trials
Reporter: Aviva Lev-Ari, PhD, RN
4.2.2 Fractional Flow Reserve–Guided PCI vs Drug Therapy for Stable Coronary Artery Disease
Reporter: Aviva Lev-Ari, PhD, RN
4.3 In Search for CAD Causes
4.3.1 Females and Non-Atherosclerotic Plaque: Spontaneous Coronary Artery Dissection – New Insights from Research and DNA Ongoing Study
Reporter: Aviva Lev-Ari, PhD, RN
4.3.2 Clinical Trials Results for Endothelin System: Pathophysiological role in Chronic Heart Failure, Acute Coronary Syndromes and MI – Marker of Disease Severity or Genetic Determination?
Curator: Aviva Lev-Ari, PhD, RN
4.4 Milestones in CAD Therapy: Vascular Repair and Devices
4.4.1 Endo-vascular Aortic Repair: A New Tool for Procedure Planning
Reporter: Aviva Lev-Ari, PhD, RN
4.4.2 Biomaterials Technology: Models of Tissue Engineering for Reperfusion and Implantable Devices for Revascularization
Author and Curator: Larry H Bernstein, MD, FACP and Curator: Aviva Lev-Ari, PhD, RN
https://pharmaceuticalintelligence.com/2013/05/05/bioengineering-of-vascular-and-tissue-models/
4.4.3 Advanced Peripheral Artery Disease (PAD): Axillary Artery PCI for Insertion and Removal of Impella Device
Reporter: Aviva Lev-Ari, PhD, RN
Chapter 5: Genomics and Biomarkers of Cardiovascular Diseases
5.1 Genomics as a Determinant and Gene Therapy Potential
5.1.1 Summary of Genomics and Medicine: Role in Cardiovascular Diseases
Author: Larry H. Bernstein, MD, FCAP
5.1.2 Gene-Silencing and Gene-Disabling in Pharmaceutical Development
Curator: Larry H. Bernstein, MD, FCAP
5.1.3 Synthetic Biology: On Advanced Genome Interpretation for Gene Variants and Pathways: What is the Genetic Base of Atherosclerosis and Loss of Arterial Elasticity with Aging
Curator: Aviva Lev-Ari, PhD, RN
5.1.4 “Sudden Cardiac Death,” SudD is in Ferrer inCode’s Suite of Cardiovascular Genetic Tests to be Commercialized in the US
Curator: Aviva Lev-Ari, PhD, RN
5.1.5 Calcium Cycling (ATPase Pump) in Cardiac Gene Therapy: Inhalable Gene Therapy for Pulmonary Arterial Hypertension and Percutaneous Intra-coronary Artery Infusion for Heart Failure: Contributions by Roger J. Hajjar, MD
Curator: Aviva Lev-Ari, PhD, RN
5.1.6 Genetics of Aortic and Carotid Calcification: The Role of Serum Lipids
Reporter: Aviva Lev-Ari, PhD, RN
5.1.7 Transposon-mediated Gene Therapy improves Pulmonary Hemodynamics and attenuates Right Ventricular Hypertrophy: eNOS gene therapy reduces Pulmonary vascular remodeling and Arterial wall hyperplasia
Reporter: Aviva Lev-Ari, PhD, RN
5.1.8 Lysyl Oxidase (LOX) gene mis-sense mutation causes Thoracic Aortic Aneurysm and Dissection (TAAD) in Humans because of inadequate cross-linking of collagen and elastin in the aortic wall. Mutation carriers may be predisposed to vascular diseases because of weakened vessel walls under stress conditions
Reporter: Aviva Lev-Ari, PhD, RN
5.1.9 The Implications of a Newly Discovered CYP2J2 Gene Polymorphism Associated with Coronary Vascular Disease in the Uygur Chinese Population
Author, Curator: Larry H Bernstein, MD, FCAP
5.1.10 Elastin Arteriopathy: The Genetics of Supravalvular Aortic Stenosis
Reporter: Aviva Lev-Ari, PhD, RN
5.1.11 Abdominal Aortic Aneurysm: Matrix Metalloproteinase-9 Genotype as a Potential Genetic Marker
Reporter: Aviva Lev-Ari, PhD, RN
5.1.12 Gene, Meis1, Regulates the Heart’s Ability to Regenerate after Injuries
Reporter: Aviva Lev-Ari, PhD, RN
5.1.13 CT Angiography & TrueVision™ Metabolomics (Genomic Phenotyping) for new Therapeutic Targets to Atherosclerosis
Reporter: Aviva Lev-Ari, PhD, RN
5.2 Role of Cardiac Biomarkers in Disease Diagnosis
5.2.1 Diagnostic Value of Cardiac Biomarkers
Author and Curator: Larry H Bernstein, MD, FCAP
https://pharmaceuticalintelligence.com/2014/01/04/diagnostic-value-of-cardiac-biomarkers/
5.2.2 Assessing Cardiovascular Disease with Biomarker
Author and Curator: Larry H Bernstein, MD, FCAP
https://pharmaceuticalintelligence.com/2012/12/25/assessing-cardiovascular-disease-with-biomarkers/
5.2.3 Cardiovascular Risk Inflammatory Marker: Risk Assessment for Coronary Heart Disease and Ischemic Stroke – Atherosclerosis
Reporter: Aviva Lev-Ari, PhD, RN
Serum Pentraxin 3 Levels, a newly identified inflammatory marker, indicate the complexity and severity of Coronary Artery Disease (CAD), for patients with stable angina
5.2.4 15 Novel Risk Loci for Coronary Artery Disease: found by International Consortium
Reporter: Aviva Lev-Ari, PhD, RN
5.2.5 Identification of Biomarkers that are Related to the Actin Cytoskeleton
Curator and Writer: Larry H Bernstein, MD, FCAP
Chapter 6: Circulation, Coagulation, Stroke, Thrombosis and Thrombectomy
6.2 Coagulation and Circulatory Disorders: Determinants of Thrombotic Risk
Artery walls use a simple molecule, nitric oxide, as a signal to adjust the diameter of each vessel appropriately for the variable demands of blood delivery.
6.2.1 Biochemistry of the Coagulation Cascade and Platelet Aggregation: Nitric Oxide: Platelets, Circulatory Disorders, and Coagulation Effects
Curator/Editor/Author: Larry H. Bernstein, MD, FCAP
6.2.3 ATVB (Arteriosclerosis, Thrombosis and Vascular Biology) 2014 Conference 5/1 – 5/3/2014, Sheraton Centre Toronto – Toronto, Ontario
Reporter: Aviva Lev-Ari, PhD, RN
6.2.4 Hyperhomocysteinemia interaction with Protein C and Increased Thrombotic Risk
Reporter and Curator: Larry H Bernstein, MD, FCAP
6.2.5 Triggering of Plaque Disruption and Arterial Thrombosis
Curator and Reporter: Larry H Bernstein, MD, FCAP
6.2.6 Is Pharmacogenetic-based Dosing of Warfarin Superior for Anticoagulation Control?
Reporter: Aviva Lev-Ari, PhD, RN
6.2.7 Cardiovascular Risk: C-Reactive Protein BioMarker and Plasma Fibrinogen
Curator & Reporter: Aviva Lev-Ari, PhD, RN
6.2.8 What is the Role of Plasma Viscosity in Hemostasis and Vascular Disease Risk?
Author: Larry H Bernstein, MD and Curator: Aviva Lev-Ari, PhD, RN
6.2.9 Special Considerations in Blood Lipoproteins, Viscosity, Assessment and Treatment
Author: Larry H. Bernstein, MD, FCAP and Curator: Aviva Lev-Ari, PhD, RN
The cardiovascular system is spread over a larger territory – the entire body. Coordination of functions requires signals be sent by either the nervous system or in the blood. A very small molecule, nitric oxide, controls dilation or contraction of muscular blood vessels, to adjust flow impedance, blood pressure, target tissue perfusion, and workload on the heart.
6.2.10 Prostacyclin and Nitric Oxide: Adventures in vascular biology – a tale of two mediators
Reporter: Aviva Lev-Ari, PhD, RN
6.2.11 Coagulation: Transition from a familiar model tied to Laboratory Testing, and the New Cellular-driven Model
Curator: Larry H. Bernstein, MD, FCAP
6.3 Thrombus Aspiration and Filters
6.3.1 Expanded Stroke Thrombectomy Guidelines: FDA expands treatment window for use (Up to 24 Hours Post-Stroke) of clot retrieval devices (Stryker’s Trevo Stent) in certain stroke patients
Reporter: Aviva Lev-Ari, PhD, RN
6.3.2 Thrombectomy Guidelines Filters: Device for Prevention of Pulmonary Embolism and Thrombosis
Reporter: Aviva Lev-Ari, PhD, RN
6.3.3 Thrombus Aspiration for Myocardial Infarction: What are the Outcomes One Year After
Reporter: Aviva Lev-Ari, PhD, RN
Chapter 7: Ventricular Failure: Assist Devices, Surgical and Non-Surgical
7.1 Trends in the Industry
The Voice of Series A Content Consultant: Justin D. Pearlman, MD, PhD, FACC
In addition to minimally invasive treatments for coronary disease and valve disease, there are minimally invasive alternatives to heart transplant for the dangerously weak heart (extreme heart failure) which can otherwise result in Cardiogenic Shock. These involve various means to augment or complement the pumping function of the heart, such as a Ventricular Assist Device (VAD).
With respect to the performance of Mitral Valve Replacement, the current practice favors bioprosthetic valves over mechanical valve replacement for most patients, initially just used for elderly to avoid need for coumadin, but now used at younger ages due to improvements in longevity of the bioprosthetic valves, plus less damage to red cells.
7.1.2 Percutaneous Endocardial Ablation of Scar-Related Ventricular Tachycardia
Reporter: Aviva Lev-Ari, PhD, RN
7.1.3 Implantable Synchronized Cardiac Assist Device Designed for Heart Remodeling: Abiomed’s Symphony
Reporter: Aviva Lev-Ari, PhD, RN
7.2 Left Ventricular Failure
7.2.1 Entire Family of Impella Abiomed Impella® Therapy Left Side Heart Pumps: FDA Approved To Enable Heart Recovery
Reporter: Aviva Lev-Ari, PhD, RN
7.2.2 Treatment Options for Left Ventricular Failure –Temporary Circulatory Support: Intra-aortic balloon pump (IABP) – Impella Recover LD/LP 5.0 and 2.5, Pump Catheters (Non-surgical) vs Bridge Therapy: Percutaneous Left Ventricular Assist Devices (pLVADs) and LVADs (Surgical)
Author: Larry H Bernstein, MD, FCAP And Curator: Justin D Pearlman, MD, PhD, FACC
7.2.3 Ventricular Assist Device (VAD): A Recommended Approach to the Treatment of Intractable Cardiogenic Shock
Author: Larry H Bernstein, MD, FCAP and Curator: Aviva Lev-Ari, PhD, RN
7.2.4 Experimental Therapy (Left inter-atrial shunt implant device) for Heart Failure: Expert Opinion on a Preliminary Study on Heart Failure with preserved Ejection Fraction
Article Curator: Aviva Lev-Ari, PhD, RN
7.3 Right Ventricular Failure
7.3.1 Dilated Cardiomyopathy: Decisions on implantable cardioverter-defibrillators (ICDs) using left ventricular ejection fraction (LVEF) and Midwall Fibrosis: Decisions on Replacement using late gadolinium enhancement cardiovascular MR (LGE-CMR)
Reporter: Aviva Lev-Ari, PhD, RN
Amyloidosis and Right Ventricular Hypertrophy
Amyloidosis inserts abnormal proteins into tissues – in the heart, that results in an insidious decline cardiac function marked by increased stiffness (requiring high filling pressures that wet the lungs) and decreased contractility or inotropy (pumping ability), resulting in poor circulation of nutrients to tissues and organs. Amyoloidosis is suspected when imaging shows thickened heart muscle and thickened valves with reduced function, but thickened muscle also occurs as a reaction to incomplete control of elevated blood pressures, as well as by other infiltrative disorders.
7.3.2 Amyloidosis with Cardiomyopathy
Author: Larry H Bernstein, MD, FACP
https://pharmaceuticalintelligence.com/2013/03/31/amyloidosis-with-cardiomyopathy/
Protein malnutrition lowers the oncotic (partical) pressure that keeps fluid in circulation, resulting in edema unrelated to heart failure. Transthyretin (pre-albumin) is used as a biomarker because its rapid clearance increases the significance of its concentration. However, it is also an “acute phase reactant” which means acute illness can temporarily spoil its value as a biomarker of chronic states.
Cardiovascular Diseases – Diagnostics for Emergent Cardiac Events
Chapter 8: Cardiac Imaging Diagnostic Modalities for Cardiovascular Disease Diagnosis
The Voice of Justin D. Pearlman, MD, PhD, FACC
Decisions about management of cardiovascular disease can get complex, and computer models may be useful. The following article discusses cost-benefit analysis, decision trees, and computer decision support systems, with specific examples.
Clinical Decision Support Systems for Management Decision Making of Cardiovascular Diseases
8.1 Diagnosis with Medical Imaging
8.1.1 Cardiovascular Imaging
Author: Justin D. Pearlman, MD, PhD, FACC
https://pharmaceuticalintelligence.com/2013/02/04/cardiovascular-imaging/
8.1.2 The Role of Medical Imaging in Personalized Medicine
Author & Reporter: Dror Nir, PhD
8.1.3 Risks for Patients’ and Physician’s Health in the Cath Lab
Reporter and Curator: Aviva Lev-Ari, PhD, RN
8.1.4 Among those 26 exams deemed low-value, 12 involve medical imaging, in tests that range from preoperative chest radiography to carotid artery screening for asymptomatic patients, imaging for back pain, and CT for headache and rhinosinusitis (JAMA Internal Medicine, May 12, 2014)
Reporter: Aviva Lev-Ari, PhD, RN
8.1.5 Echocardiogram Quantification: Quest for Reproducibility and Dependability
Reporter: Aviva Lev-Ari, PhD, RN
8.1.6 CVD Prevention and Evaluation of Cardiovascular Imaging Modalities: Coronary Calcium Score by CT Scan Screening to justify or not the Use of Statin
Curator: Aviva Lev-Ari, PhD, RN
8.1.17 Acute Chest Pain/ER Admission: Three Emerging Alternatives to Angiography and PCI – Corus CAD, hs cTn, CCTA
Curator: Aviva Lev-Ari, PhD, RN
8.2 Fractional Flow Reserve (FFR) CT vs Invasive FFR for PCI
8.2.1 What is the Atheroma (TCFA) of Noninvasive Diagnostic Fractional Flow Reserve (FFR) CT vs Invasive FFR for PCI?
Reporter: Aviva Lev-Ari, PhD, RN
8.2.2 Fractional Flow Reserve vs. Angiography in Non-ST-segment Elevation Myocardial Infarction
Reporter: Aviva Lev-Ari, PhD, RN
8.2.3 Fractional Flow Reserve–Guided PCI vs Drug Therapy for Stable Coronary Artery Disease
Reporter: Aviva Lev-Ari, PhD, RN
8.2.4 Asymptomatic Patients After Percutaneous Coronary Intervention: Low Yield of Stress Imaging – Population-Based Study
Reporter: Aviva Lev-Ari, PhD, RN
8.2.5 Females and Non-Atherosclerotic Plaque: Spontaneous Coronary Artery Dissection – New Insights from Research and DNA Ongoing Study
Reporter: Aviva Lev-Ari, PhD, RN
8.3.1 Chest Pain: Cardiac MRI provides the Picture of MI
Reporter: Aviva Lev-Ari, PhD, RN
https://pharmaceuticalintelligence.com/2014/06/03/chest-pain-cardiac-mri-provides-the-picture-of-mi/
8.3.2 Stanford University researchers have developed a scanner that unites optical, radioluminescence, and photoacoustic imaging to evaluate for Thin-Cap Fibro Atheroma (TCFA)
Reporter: Aviva Lev-Ari, RN
8.3.3 Hybrid Imaging 3D Model of a Human Heart by Cardiac Imaging Techniques: CT and Echocardiography
Reporter: Aviva Lev-Ari, PhD, RN
8.3.4 Low-dose and High-resolution Cardiac Imaging with Revolution™ CT
Reporter: Aviva Lev-Ari, PhD, RN
8.3.5 Coronary CT Angiography versus Standard Evaluation in Acute Chest Pain
Reporter: Aviva Lev-Ari, PhD, RN
8.3.6 ‘Mammogram for the heart’ can predict heart attack by Dr. James Min, Director of the Dalio Institute of Cardiovascular Imaging at New York-Presbyterian Hospital and Weill Cornell Medical College
Reporter: Aviva Lev-Ari, PhD, RN
8.4.2 Coronary Circulation Combined Assessment: Optical Coherence Tomography (OCT), Near-Infrared Spectroscopy (NIRS) and Intravascular Ultrasound (IVUS) – Detection of Lipid-Rich Plaque and Prevention of Acute Coronary Syndrome (ACS)
Author, and Content Consultant to e-SERIES A: Cardiovascular Diseases: Justin Pearlman, MD, PhD, FACC and Article Curator: Aviva Lev-Ari, PhD, RN
The Voice of Justin D Pearlman, MD, PhD, FACC
Therapeutic endpoints for treatment of atherosclerosis have relied on lipid blood tests, but benefits of statins occur in patients with normal “target” levels prior to therapy. Some have argued the benefits relate not only to changes in blood lipids but also anti-inflammatory effects of statins. Carotid intimal thickness by high frequency ultrasound has been offered as an alternative method to guide success of halting and/or reversing plaque buildup in arteries. The following article aims to offer another method which can be applied to coronary arteries, the aorta, and other vessels not reachable by surface high frequency ultrasound.
8.4.4 Normal and Anomalous Coronary Arteries: Dual Source CT in Cardiothoracic Imaging
Reporters: Justin D Pearlman, MD, PhD, FACC and Aviva Lev-Ari, PhD, RN
The Voice of Justin D. Pearlman, MD, PhD, FACC
The adequacy of coronary arteries (blood supply to the heart) to adapt to challenges is measured as fractional flow reserve. That measurement use to require catheterization, but now that can be computed from CT imaging. That method helps identify if a lesion is “Flow Limiting” rather than rely only on anatomic stenosis severity.
Chapter 9: Emergent Cardiac Events – Unstable Angina, Acute Myocardial Infarction (AMI), Asystole (cardiac arrest rhythm), Acute Coronary Syndrome
What is the treatment for Asystole? – “Sudden Cardiac Death,” SudD
The advanced cardiac life support (ACLS) 2010 guidelines allow vasopressin 40 IU IV as a 1-time dose treatment option in VF and asystole. This treatment can be given either before epinephrine or after the first dose of epinephrine. Dec 26, 2015
9.1 Accurate Identification and Treatment of Emergent Cardiac Events
Curator: Larry H Bernstein, MD, FCAP
9.2 Protein Clue to Sudden Cardiac Death: Research @Oxford University
Reporter: Aviva Lev-Ari, PhD, RN
9.3 Evidence for Overturning the Guidelines in Cardiogenic Shock
Reporter: Aviva Lev-Ari, PhD, RN
9.4 Acute Myocardial Infarction
9.4.1 Previously undiscerned value of hs-troponin
Curators: Larry H. Bernstein, MD, FCAP and Aviva Lev-Ari, PhD, RN
https://pharmaceuticalintelligence.com/2016/06/18/previously-undiscerned-value-of-hs-troponin/
9.4.2 What is the history of STEMI? What is the current treatment for Cardiogenic Shock? The Case Study of Detroit Cardiogenic Shock Initiative
Reporter: Aviva Lev-Ari, PhD, RN
9.4.3 Thrombus Aspiration for Myocardial Infarction: What are the Outcomes One Year After
Reporter: Aviva Lev-Ari, PhD, RN
9.4.4 On-Hours vs Off-Hours: Presentation to ER with Acute Myocardial Infarction – Lower Survival Rate if Off-Hours
Reporter: Aviva Lev-Ari, PhD, RN
9.4.5 Acute Myocardial Infarction: Curations of Cardiovascular Original Research – A Bibliography
Curators: Aviva Lev-Ari, PhD, RN and Larry H Bernstein, MD, FCAP
9.4.6 Culprit-Lesion Over Multivessel PCI in STEMI Patients
Reporter: Aviva Lev-Ari, PhD, RN
9.4.7 Myocardial Infarction: The New Definition After Revascularization
Reporter: Aviva Lev-Ari, PhD, RN
9.4.8 New Definition of MI Unveiled, Fractional Flow Reserve (FFR) CT for Tagging Ischemia
Reporter: Aviva Lev-Ari, PhD, RN
A novel approach uses micoscopic gold particles to impart electric signal to the heart of MI patients.
9.4.9 MIT’s Promise for the MI Patient: A new cardiac patch uses Gold Nanowires to enhance Electrical Signaling between heart cells
Curator: Aviva Lev-Ari, PhD, RN
9.5 The Warning Symptoms for a Diagnosis in Suspect
9.5.1 Acute Chest Pain/ER Admission: Three Emerging Alternatives to Angiography and PCI
Curator: Aviva Lev-Ari, PhD, RN
9.6 The Biomarker Troponin
9.6.1 Recent Insights into the High Sensitivity Troponins for Acute Coronary Syndromes
Curator: Larry H Bernstein, MD, FCAP
9.6.2 More on the Performance of High Sensitivity Troponin T and with Amino Terminal Pro BNP in Diabetes
Writer and Curator: Larry H. Bernstein, MD, FCAP
9.6.3 Atherosclerosis Risk and Highly Sensitive Cardiac Troponin-T Levels in European Americans and Blacks: Genome-Wide Variation Association Study
Reporter: Aviva Lev-Ari, PhD, RN
9.6.4 Troponin I in acute decompensated heart failure: insights from the ASCEND-HF study
Writer and Curator: Larry H Bernstein, MD, FCAP and Curator: Aviva Lev-Ari, PhD, RN
https://pharmaceuticalintelligence.com/2013/06/30/troponin-i-in-acute-decompensated-heart-failure/
9.6.5 Preparing the United States for High-Sensitivity Cardiac Troponin Assays
Curator: Larry Bernstein, MD, FCAP
https://pharmaceuticalintelligence.com/2013/06/13/high-sensitivity-cardiac-troponin-assays/
9.6.6 Dealing with the Use of the High Sensitivity Troponin (hs cTn) Assays: Preparing the United States for High-Sensitivity Cardiac Troponin Assays
Author and Curator: Larry H Bernstein, MD, FCAP and Author and Curator: Aviva Lev-Ari, PhD, RD
https://pharmaceuticalintelligence.com/2013/05/18/dealing-with-the-use-of-the-hs-ctn-assays/
Cardiovascular Diseases – Diagnostics and Management of Chronic Cardiovascular Disorders
Chapter 10: Management of Chronic Cardiovascular Disorders: Heart Failure (HF), CHF, Need for Heart Transplant (HT)
10.1 End-stage Heart Failure: The Heart Transplant Process, Devices and Survival post implantation
Heart & Heart-Lung Transplant:
Voices of Larry H. Bernstein, MD, FCAP and Justin Pearlman MD, PhD, FACC
While heart surgery is the primary means to improve quality and quantity of life from severe valve disease and/or heart failure, there is a momentum building for less invasive competition, with newer options analogous to the alternatives to surgery achieved by the catheter approach to coronary artery disease. There are a growing number of mechanical means of supporting a failing heart that can delay or possibly serve as an alternative to transplantation.
This section presents examples of achievements relating to preparation for or performance of heart or heart lung transplants lead by centers of excellence in cardiothoracic and vascular surgery, without any intention of ranking or subjugating the numerous other centers of excellence. For example, the Mayo Clinic in Rochester Minnesota has fame for excellence, but it also has very strong competition from Rush Medical Center in Chicago, the University of Michigan, Ann Arbor, the Henry Ford Hospital and the William Beaumont Hospital in Oakland, Michigan, to name a few other centers of excellence in the region. Similarly, Centers of Excellence in San Diego have regional competition from UCLA, Cedars-Sinai, Stanford and UC San Francisco. The Cleveland Clinic is now developing an educational venture with the outstanding Western-Reserve Medical School, a short distance away, in Cleveland, Ohio.
10.1.8 Mechanical Circulatory Assist Devices as a Bridge to Heart Transplantation or as “Destination Therapy“: Options for Patients in Advanced Heart Failure
Author and Curator: Larry H. Bernstein, MD, FCAP and Curator: Aviva Lev-Ari, PhD, RN
https://pharmaceuticalintelligence.com/2013/06/30/advanced-heart-failure/
The Voice of Larry H. Bernstein, MD, FCAP on Immune suppression and Heart Transplants
Heart transplants (and heart lung transplants) require immune suppression so that the body defenses against foreign cell activities such as infection, cancer or transplants to not succeed in rejecting the transplant. Thus transplant patients have risks not only of organ rejection (autoimmune attack) but also serious infections and cancers. Replacing the original organ with one from a donor (orthotopic transplant) comes with serious complications. In addition to transplant rejection, infection, cancer, accelerated atherosclerosis, also vasoplegia is a serious problem of increased vascular resistance thought to be due to dysregulation of endothelial homeostasis and subsequent endothelial dysfunction secondary to direct and indirect effects of multiple inflammatory mediators. Vasoplegia has been observed in all age groups and in other clinical settings besides transplants; vasoplegia has also been associated with protamine reaction, other anaphylaxis, sepsis, hemorrhagic shock, or hemodialysis and cardiac surgery.
10.1.9 After Cardiac Transplantation: Sirolimus acts as immunosuppressant Attenuates Allograft Vasculopathy
Author and Curator: Larry H Bernstein, MD, FCAP and Curator: Aviva Lev-Ari, PhD, RN
The Voice of Justin D. Pearlman, MD, PhD, FACC on Electric System of the Heart: Pacemakers & Implantable Cardiac Defibrillators (ICD)
The electric system of the heart communicates when each portion of the heart should contract (beat). An enlarged failing heart has longer and slower pathways often with the complication of asynchronous contraction (poorly timed electric activation of muscle movement), so different parts activate staggered over time instead of as a coordinated effort, resulting in a relatively uncoordinated wobble rather than a maximally effective beat. Cardiac Resynchronization consists of inserting a plurality of pacemaker wires designed and adjusted to compensate for bad timing so that the contraction effort is more synchronized. If the electrical activation is asynchronous, then assuming that the axis of maximal difference in timing is parallel to one of the electrocardiogram (ECG) lead views, then the ECG will show wide activation in at least one lead (QRS duration > 120 msec). Both MRI and Echo imaging have been applied to identify the axis of maximal difference in timing to help guide placement of lead wires in the heart and timing offsets between the lead wire stimulations of regional heart contraction (a topic studied by Dr. Pearlman using MRI and TEE). Unfortunately, remedy is limited – if leads are placed by catheter, the location choices are limited to the apex of the right ventricle, and a left ventricular branch of the coronary sinus. At surgery, there is greater freedom to place epicardial leads at favorable locations in viable myocardium. If the heart is prone to dangerous dysrhythmias such as ventricular tachycardia or ventricular fibrillation, pacing can sometimes help, but the surest method is delivery of an electric shock to stop the bad rhythm, and resynchronize preparation for a better rhythm. The decision of when to burst pace and when to shock is computed by an implantable computer chip as part of an implantable cardiac defibrillator (ICD). Patients with irreversible heart failure with ejection fraction remaining <35% after >3 months of optimized triple therapy (beta blocker, angiotensin-converting-enzyme inhibitor, aldosterone inhibitor) are prone to death from arrhythmia, and may live considerably longer with an ICD.
10.1.10 Cardiac Resynchronization Therapy (CRT) to Arrhythmias: Pacemaker/Implantable Cardioverter Defibrillator (ICD) Insertion
Curators: Justin D. Pearlman, MD, PhD, FACC and Aviva Lev-Ari, PhD, RN
The Voice of Justin D. Pearlman, MD, PhD, FACC
Patients with heart failure develop abnormal breathing patterns mediated by the phrenic nerve which controls diaphragm contractions. Nerve stimulators enable computer control to change such patterns. In particular, there is an abnormal pattern of breathing called Cheyne-Stokes Respiration characterized by progressively deeper and/or faster breathing followed by a decrease leading to a brief stoppage of breathing. Investigators have looked at taking control of the phrenic nerve to alleviate the Cheyne-Stokes abnormal respiration pattern.
10.2.2 Refractory Hypertension, Renal Artery Denervation Procedures and Alternatives in Device/Tool Design – Industry Trends
10.2.2.1 Renal Sympathetic Denervation: Updates on the State of Medicine
Curator: Aviva Lev-Ari, PhD, RN
10.2.2.2 PAD and Resistance Hypertension: Renal Artery Intervention using Stenting
Reporter: Aviva Lev-Ari, PhD, RN
10.2.2.3 Treatment of Refractory Hypertension via Percutaneous Renal Denervation
Curator: Aviva Lev-Ari, PhD, RN
10.2.2.4 Potential Explanation to Lack of Efficacy Results of SYMPLICITY HTN-3 Study that Contradict Most Published Data on Renal Denervation
Reporter: Aviva Lev-Ari, PhD, RN
10.2.2.5 Market Impact on Global Suppliers of Renal Denervation Systems by Pivotal US Trial: Metronics’ Symplicity Renal Denervation System FAILURE at Efficacy Endpoint
Curator and Reporter: Aviva Lev-Ari, PhD, RN
10.2.2.6 St. Jude’s CEO is still betting on EnligHTN IV Study Renal Denervation System, despite Medtronic’s setback related to SYMPLICITY Phase IV
Reporter: Aviva Lev-Ari, PhD, RN
10.2.2.7 Renal Denervation Technology of Vessix Vascular, Inc. been acquired by Boston Scientific Corporation (BSX) to pay up to $425 Million
Reporter: Aviva Lev-Ari, PhD, RN
Cardiovascular Diseases – Treatment Options
Introduction to Invasive Procedures by Surgery versus Catheterization
The Voice of Series A Content Consultant: Justin D. Pearlman, MD, PhD, FACC
Coronary artery disease (blockages in blood supply) causes heart attacks by two methods: (1) severe narrowing that provides insufficient nutrition and oxygen to a region of heart muscle compared to its needs (hence the tissue commits a form of hara-kari called apoptosis), or (2) unstable plaque that can crack, cause localized hemorrhage into the wall of a coronary artery, and clot, suddenly stopping blood supply to a region of heart muscle, also triggering apoptosis and cell death with replacement of heart muscle by scar tissue. As little as ten minutes of stopped blood supply can trigger cell death (myocardial infarction), hence the phrase “time is muscle” with urgency to relieve problems by nitrates and catheterization. The blood supply to the heart consists of the left main (LM, a short vessel that promptly branches to the left anterior descending (LAD), and the left circumflex (LCX)), and the right coronary (RCA) which often gives rise to the posterior descending artery (PDA) (10% of patients get PDA blood supply as an extension of the LCX). Based on the normal branching pattern of blood supply to the heart, lesions causing blockage may cause heart attacks affecting different regions:
As one in four people eventually get a heart attack (myocardial infarction, death of heart muscle), and a third die from that, there have been great efforts at prevention. Heart attacks can be prevented by
(1) not smoking,
(2) small waist (<35 inches for women, <40 inches for men),
(3) prevent or control of diabetes,
(4) control of lipids/cholesterol.
(5) control of inflammation (limited data favors keeping hs-CRP below 2.0)
Additional benefits have been demonstrated from fish oil (controversy about inconsistent association with prostate cancer not withstanding), alcohol (1/2 to 2 drinks daily elevates apoproteins and HDL which reverses lipid deposits in arterial walls), and statins even if LDL is not high, and possibly red wine or grape congeners, and possibly an anti-inflammatory biologic (canakinumab – but the FDA declined allowing that benefit label). All of this aims to prevent the development of blockages. Once blockages do develop, one may consider balloon angioplasty to open the obstruction, bare metal stent to keep it propped open, drug-eluting stent to inhibit reactive tissue growth, or bypass surgery.
While heart surgery is the primary means to improve quality and quantity of life from severe valve disease, there is a momentum building for less invasive competition analogous to the catheter approach to coronary artery disease.
Introduction to Cardiothoracic Surgery
The Voice of Series A Content Consultant: Justin D. Pearlman, MD, PhD, FACC
VIEW VIDEOS – Courtesy of YouTube as well as the individual sponsors of the links cited below.
- VIDEO: Cardiac Surgery Simulation – Graphics Hardware meets Congenital Heart Disease
- VIDEO: SPY Imaging: Quality in Heart Bypass Surgery
The major cardiovascular surgeries include (1) coronary artery bypass grafting (CABG), (2) heart valve repair or replacement, (3) repair of a defect in the heart or a blood vessel, (4) reconstructions to compensate for a congenital defect, (5) insertion of a device to modify electric, pump or blood pressure control activities. Surgery on blood vessels outside the chest constitutes a separate specialty distinct from cardiothoracic.
The word bypass in relation to CABG has two meanings: (1) a bypass route to delivery blood around a narrow or obstructed segment, and (2) use of a bypass pump that circumvents the pumping role of the heart and the oxygenation role of the lungs so that the heart may be stopped for several hours with minimal interruption of delivery of oxygenated blood to the brain and the rest of the body (the brain does not tolerate >5-10 minutes interruption unless it is chilled). Venous blood is diverted to the bypass pump which oxygenates the blood
Cardiothoracic Surgery at Tertiary Academic Hospitals in the US
The Voice of Co-Editor of LPBI Group’s 18-Volume BioMed e-Series, Larry H. Bernstein, MD, FCAP
The following articles are a review of a decade of cardiovascular surgery and interventional cardiology at the Presbyterian Hospital, Columbia University Medical Center and Weill Cornell Medical Center.
This section includes analysis of morbidity and mortality, including 10 year survival rates for coronary artery bypass grafts (CABG heart surgery) versus percutaneous catheter interventions (PCI), presented along with discussion of deficiencies inherent in such studies, and conclusions. The first major comparison addresses CABG vs Plain Old Balloon Angioplasty (POBA), showing similar survival rates at 10 years for patients qualifying for either procedure. The high rate of re–stenosis observed in PCI, requiring a second procedure, declined substantially in the time since the initial comparisons as a result of technological innovations instent design and in diameter of insertion device. The comparisons involve moving targets, as drug-eluting stents (DES) continue to improve. These studies involve 10,000 matched patients.
Mortality rates were adjusted using Cox proportional hazards method, adjusting for
- severity of disease
- comorbidity
- LAD only
- multiple vessel disease
As most patients are presented the options of catheter interventions versus bypass surgery, the results impact patient shared decision-making. An early study of CABG versus medical therapy was biased in favor of medical therapy, achieved by stringent exclusion criteria eliminating large percentage of patients with left main CAD and an ejection fraction of < 0.40. Many of these patients would have crossed over to CABG. The study was done prior to advances in medical therapy, as well as advances in imaging, myocardial protection, anesthesia, and LIMA.
The important findings are as follows:
- The long-term survival rates of CABG and PCI are comparable, if we compare a patient cohort that qualifies for both procedures.
- The Achille’s heel of PCI has been restenosis, but the risk of re-stenosis has declined with improved devices.
- The risk-adjusted in-hospital mortality for CABG vs stent was found to be comparable. There is an advantage to stenting, when:
- Patient is > 65 years
- Not an insulin-dependent diabetic
- Patient also has significant non-coronary vascular disease.
There is no intermediate-term survival advantage of CABG over stenting in patients with normal ejection fraction who have multivessel disease that can be treated percutaneously.
Randomized clinical trials established advantages of CABG over medical therapy in patients with
- triple-vessel CAD
- left main coronary artery stenosis
- double-vessel CAD with proximal left anterior descending (LAD) coronary artery stenosis
- left ventricular dysfunction
- insulin dependent diabetics
The Duke database study showed better survival rates with PTCA than with CABG in patients with single-vessel CAD, whereas CABG produced better survival than did PTCA in patients with severe, triple-vessel CAD. There are important considerations when reviewing these trials:
- stents were not used in the PTCA patients
- operative mortality rates for the CABG groups were higher than the rates currently found in the Society of Thoracic Surgeons (STS) database
- the inclusion/exclusion criteria of these studies eliminated a high percentage of those patients who might have benefited more from CABG than from PTCA
11.1 Hybrid Cath Lab/OR Suite
VIEW VIDEOS:
- The New Hyrid Operating Room. Westchester Medical Ceneter
- Hybrid Operating Room Installation. Maquet
https://www.youtube.com/watch?v=Se_NpFTCFRc The Corpus Christi-Medical Center, TX
The Voice of Series A Content Consultant: Justin D. Pearlman, MD, PhD, FACC
In an uncommon reversal of opinion, the combined forces of the American Heart Association (AHA) and the American College of Cardiology (ACC) reviewed compelling data and reversed a prior assessment on the need for an on-site cardiovascular surgery support for sites offering interventional cardiac catheterization. The data show that sites offering the intervention without a surgeon achieve better results that sites that ship patients out for the interventions, and that the risk without on-site thoracic surgery backup is negligible.
11.1.6 Patients with Heart Failure & Left Ventricular Dysfunction: Life Expectancy Increased by coronary artery bypass graft (CABG) surgery: Medical Therapy alone and had Poor Outcomes
Curator: Aviva Lev-Ari, PhD, RN
The Voice of Series A Content Consultant: Justin D. Pearlman, MD, PhD, FACC
As minimally interventional techniques improve, patients are offered a choice of invasive surgical remedies or less invasive procedures (video assisted, robotic, or percutaneous). The decision should not rest on the size of the scar or even the upfront risk and discomfort, but rather should weigh all aspects of the risks and benefits. In addition to the risks and benefits for the current problem, one should also consider why the problem occurred and its likelihood of recurrence. Open chest surgery has a clear disadvantage when it comes to recurrences, as the scars from first surgery interfere with second surgery. Opening the chest (sternotomy) for a second or third time poses elevated risks analyzed herein. This article reviews data from major centers addressing the risks from repeat sternotomy and from minimally invasive cardiovascular surgeries. Any invasion of the body elevates risk of infection, which can lead to sepsis and possible death, so that risk is also addressed.
11.2.5 Nitric Oxide and it’s impact on Cardiothoracic Surgery
Author, curator: Tilda Barliya PhD
The Voice of Series A Content Consultant: Justin D. Pearlman, MD, PhD, FACC
Comparison of the 10-year and 15-year survivals after CABG demonstrated benefit from a change in graft sources used at the Mayo Clinic and widely adapted by others: vascular grafts from the left internal mammary artery (LIMA) instead of just leg veins, for multiple grafts (up to 3), LIMA-to-LAD plus grafts using LIMA or radial artery vs LIMA/saphenous vein (SV).
11.2.6 CABG Survival in Multivessel Disease Patients: Comparison of Arterial Bypass Grafts vs Saphenous Venous Grafts
Author and Curator: Larry H. Bernstein, MD, FCAP and Curator: Aviva Lev-Ari, PhD, RN
11.3 Coronary Angioplasty: Percutaneous Coronary Intervention (PCI)
The Voice of Series A Content Consultant: Justin D. Pearlman, MD, PhD, FACC
Arterial access typically starts by passing a needle through skin into an access artery, such as the femoral artery in the groin, or the radial artery at the wrist or brachial artery at the inside of the elbow. A wire is passed through the needle (Seldinger technique) to serve as a guide wire conducting hollow items into the artery. Once the wire is in place the needle is pulled off over the wire while the wire remains threaded into the artery, then the needle is replaced by plastic tubing, called an introducer, threaded over the guide wire. Large diameter tubing may require surgical cut down into the artery, and subsequent arterial repair (there are mechanical inserts that facilitate artery wall closure and repair). What occurs next depends on the target of treatment. To diagnose coronary artery obstructions, there are different designs of catheters consisting of long hollow tubing pre-shaped to catch the entrance of the left or right coronary arteries. To place a balloon across a lesion within a coronary artery is more challenging, so a longer thin guide wire is threaded down the catheter through the lesion, and a new catheter is threaded over that wire to place a balloon, and later a balloon with a stent on it, centered in the lesion, for deployment.
For percutaneous access (path starting by skin penetration into a blood vessel) to replace the aortic valve, the path is very similar to that for coronary arteries: femoral artery, up the aorta, around the arch of the aorta, to the aortic root. In theory, the mitral valve could be reached by passing through the aortic valve across the left ventricle, to the mitral valve, but the submitral apparatus would be hard to navigate. Alternatively, one may use venous access: femoral vein to inferior vena cava to right atrium, then pass through the foramen ovale (a trap door between right and left atria, normally closed after birth) into the left atrium, to the mitral valve, with no interference from the submitral (left ventrcular) apparatus of chordae and papilllary muscles.
Once the catheter is in place, it can be used to perform a number of procedures including
- coronary angiography
- flow reserve measurement
- balloon angioplasty (dilation and cracking of obstructions)
- stent placement
- balloon septostomy (creating an opening in the interatrial septum, to modify circulation impeded by congenital abnormalities)
- embolization to occlude a vessel or to inject alcohol to kill obstructive musle
- localize delivery of a thrombolytic or anti-spasm medication or angiogenesis or vasculogenesis or stem cell therapies
- percutaneous closure of a septal defect
- electrophysiology study
- ablation of dysfunctional electro-conductive pathways or arrhythmia riggers
- valvuloplasty
- valve placement
- aneurysm repair tube graft
The decision to intervene on a vascular lesion considers:
- length of the abnormal segment
- flow reserve (physiologic impact)
- patient age and co-morbidities (ailments)
- extent of calcification
- renal function
- pathway to the lesion
- branch anatomy that may be affected by the planned intervention
There has been considerable controversy about the role of catheterization (percutaneous catheter intervention or PCI) as an alternative to coronary artery bypass surgery (CABG). PCI has clearly been vital when applied within the first hour of a discrete coronary occlusion (heart attack) and may be as valuable even out to 12 or more hours, particularly with incomplete injuries (“stuttering heart attack”). Both PCI and CABG relieve chest pain due to impaired blood supply to the heart (ischemia). CABG provides alternate routes for blood delivery competing with the diseased segments, while PCI repairs (recanulates) selected obstructed segments of coronary arteries. PCI is faster and may be repeated far more often in the future. Benefits on life expectancy have been more challenging to demonstrate. While early comparisons demonstrated advantage of surgery for diabetics and patients with 3 vessel obstruction or left main obstruction or equivalent, the continual changes in technique for both surgery and PCI require updated comparisons. PCI has evolved from plain old balloon angioplasty (POBA), which lead to early restenosis (recurrence of narrowing in the arterial channel) and/or thrombosis (clot formation), requiring repeated interventions often within 6 months. Stents (wire cages to keep the vessels open) addressed the early restenosis problem, but reaction to the metal results in another mechanism for early failure: endothelial tissue in-growth (in-stent stenosis) as well as more frequent thrombosis. Use of stronger anti-platelet medications (e.g., aspirin plus clopidogrel) reduced the thrombosis issue, and addition of medications in the stent to block endothelial growth (drug-eluting stents, DES) reduced the problem with in-stent stenosis but prolonged the problem with thrombosis.
As a general clinical rule, the aspirin and clopidogrel interfere with platelet function sufficient to put off any surgeries – the anti-platelet treatment after stent is deemed uninterruptable for 1-2 months after a bare metal stent, and 6-12 months after a drug-eluting stent, with fading benefit thereafter over 2 years (then aspirin alone can suffice). Genetic studies identified that some patients are not protected by clopidogrel plus aspirin, so further studies investigate alternatives such as prasugrel and ticagrelor. Clopidogrel is a thienopyridine which selectively and irreversibly inhibits the platelet adenosine 5’-diphosphate (ADP) P2Y12 receptor, further inhibiting platelet aggregation (the “white” component of blood clots) over aspirin alone. The Clopidogrel in Unstable angina to prevent Recurrent Events (CURE) trial, randomly assigned 12,562 patients with acute coronary syndrome (ACS) to receive clopidogrel (300 mg loading followed by 75 mg once daily) or placebo in addition to aspirin for 3 to 12 months; after an average follow-up of 9 months, the major adverse cardiovascular event rate (MACE= death from cardiovascular causes, myocardial infarction or stroke) occurred in 9.3% vs 11.4%, respectively (P < 0.001), due to fewer myocardial infarctions in those treated with clopidogrel (5.2% vs 6.7%, P < 0.001). Prasugrel is a thienopyridine ADP receptor inhibitor, which irreversibly binds to the P2Y12 receptor. In comparison to clopidogrel, prasugrel acts more quickly, more consistently, and more potently, and its value was examined in the Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition with Prasugrel-TRITON-TIMI 38. Analysis of 13,608 patients treated with Prasugrel 60 mg loading dose and a 10 mg daily maintenance dose versus clopidogrel 300 mg loading dose and a 75 mg daily maintenance dose showed prasugrel more was effective than clopidogrel in reducing MACE.
12.3.4 Vascular & Peripheral Artery Disease
The Voice of Series A Content Consultant: Justin D. Pearlman, MD, PhD, FACC
Peripheral Vascular Disease commonly refers to problems with branch vessels from the aorta to the head and limbs, but often is extended to include problems in the aorta such as excessive regional dilation (aneurysm). While less widely distributed than coronary artery treatment centers, there are numerous centers with varied offerings to treat peripheral vascular disease. The examples cited are with no intended prejudice regarding other quality centers.
As with catheter intervention versus bypass surgery, left ventricular assist devices (LVAD) versus heart transplant, percutaneous valve replacement versus heart valve surgery, so too, there are advances in less invasive treatment of blocked arteries to the brain or to the limbs. The use of stents to revascularize the arteries to the brain raised grave concerns about emboli (blood born debris) but results have been quite good.
We have seen in the evolution of endovascular surgery mirroring the advances applied to coronary artery stenosis treatments, starting with balloon dilation, then stents (wire cages to keep the vessel open) then drug-eluting stents (DES) to suppress problems from tissue reaction to stents. Peripheral arteries have larger diameter than coronary arteries so there are problems with insertion and post-insertion restenosis. The stent diameters require a wide range to fit the need.
Onyx glue has been successful for sealing leaks after endovascular repair.
The Voice of Larry H. Bernstein, MD, FCAP on Peripheral Vascular Disease and Vascular Surgery
There are many famous centers focused on the treatment of vascular disease. The clear benefit of completing revascularization within one hour of onset of a heart attack has promoted dissemination of catheter interventions and cardiac surgery throughout the country. There are fewer centers of excellence for peripheral vascular disease. Without prejudice, we discuss details of the offerings at specific centers.
This series depicts the scientific and medical contributions of the Vascular Surgery Section at Massachusetts General Hospital, including carotid artery, thoracic aorta and abdominal aortic aneurysm, under Dr. Richard Cambria. The published work ranges from standards definition related to the type of procedure and complexity based on comorbidities and surgical volume to special problems encountered in endovascular surgery of thoracic aorta, abdomenal aorta, carotid artery, and vessels of the lower extremities. These are topics discussed:
1. Impact of hospital volume and type on outcomes of open and endovascular repair of descending thoracic aneurysms in the United States Medicare population.
2. Why calls for more routine carotid stenting are currently inappropriate: an international, multispecialty, expert review and position statement; Predictors of clamp-induced electroencephalographic changes during carotid endarterectomies; Centers for Medicare and Medicaid Services conducts a medical evidence development and coverage advisory committee meeting on carotid atherosclerosis. Centers for Medicare and Medicaid Services conducts a medical evidence development and coverage advisory committee meeting on carotid atherosclerosis: executive summary.
3. Commentary regarding “lower-extremity endovascular interventions for Medicare beneficiaries: comparative effectiveness as a function of provider specialty” by Zafar et al. J Vasc Interv Radiol 2012; 23:3-9.
4. Impact of chronic kidney disease on outcomes after abdominal aortic aneurysm repair.
5. Improved results using Onyx glue for the treatment of persistent type 2 endoleak after endovascular aneurysm repair.
There are key points to be learned in this material offered. Hospitals that have volumes are not only less restrictive in the procedures they handle, but also they have a staff that can handle the most difficult cases. The special problems of carotid stenting are made clear, and special problems of endovascular surgery on the aorta near the origin of the renal arteries are discussed.
The characteristics of a peripheral target artery that influence graft patency include:
- the diameter of the target artery
- the presence or absence of diffuse disease within the artery
- whether or not the artery requires endarterectomy
12.3.4.1 Resistance Hypertension: Renal Artery Intervention using Stenting
Reporter: Aviva Lev-Ari, PhD, RN
12.3.4.3 Open Abdominal Aortic Aneurysm (AAA) repair (OAR) vs. Endovascular AAA Repair (EVAR) in Chronic Kidney Disease (CKD) Patients – Comparison of Surgery Outcomes
Author and Curator: Larry H. Bernstein, MD, FCAP and Curator: Aviva Lev-Ari, PhD, RN
The Voice of Justin D. Pearlman, MD, PhD, FACC
Minimally invasive repair of the aorta: Whereas atherosclerosis offers potentially somewhat protective stiffening of the arterial wall, it can promote clots, athero-emboli, and failure of the remodeling can lead to an outward ballooning, or aneurysm, that promotes both clot formation and wall or lining tears or rupture (a cause of sudden death). Passage of a needle, then wire, then catheter, then stent delivery system, can offer repair without surgery.
Chapter 13: Valve Replacement, Valve Implantation and Valve Repair
The Voice of Series A Content Consultant: Justin D. Pearlman, MD, PhD, FACC
As catheter techniques evolved to compete with bypass surgery they progressed from balloon cracking of obstructive lesions (POBA=plain old balloon angioplasty) to placement of stents (wire fences). Surgeons sometimes use in-stent valves, and now devices analogous to in-stent valves can be placed by catheter for valve replacement in patients with too much co-morbidity to go through heart surgery. Aortic valve replacement by stent (TAVR) has had sufficient success to be considered for all patients who have sufficient impairment to merit intervention. The diameter is large, so a vascular surgeon participates in the arterial access and repair of the access site.
13.3 Mitral Valve
13.3.1 Transcatheter Mitral Valve (TMV) Procedures: Centers for Medicare & Medicaid Services (CMS) proposes to cover Transcatheter Mitral Valve Repair (TMVR)
Reporter: Aviva Lev-Ari, PhD, RN
13.3.2 Mitral Valve Repair: Who is a Patient Candidate for a Non-Ablative Fully Non-Invasive Procedure?
Author, and Content Consultant to e-SERIES A: Cardiovascular Diseases: Justin Pearlman, MD, PhD, FACC and Article Curator: Aviva Lev-Ari, PhD, RN
13.3.3 Replacement of the Mitral Valve: Using the Edwards’ Sapien Aortic Valve Device
Reporter: Aviva Lev-Ari, PhD, RN
13.3.4 Less is More: Minimalist Mitral Valve Repair: Expert Opinion of Prem S. Shekar, MD, Chief, Division of Cardiac Surgery, BWH – #7, 2017 Disruptive Dozen at #WMIF17
Reporter: Aviva Lev-Ari, PhD, RN
13.3.5 Moderate Ischemic Mitral Regurgitation: Outcomes of Surgical Treatment during CABG vs CABG without Mitral Valve Repair
Curator: Aviva Lev-Ari, PhD, RN
13.3.6 Prospects for First-in-man Implantation of Transcatheter Mitral Valve by Direct Flow Medical
Reporter: Aviva Lev-Ari, PhD, RN
13.3.7 Abbott’s percutaneous MitraClip mitral valve repair device SUPERIOR to Pacemaker or Implantable Cardioverter Defibrillator (ICD) for reduction of Ventricular Tachyarrhythmia (VT) episodes
Reporter: Aviva Lev-Ari, PhD, RN
13.4 Valve-in-Valve (Aortic and Mitral) Replacements
13.4.1 First case in the US: Valve-in-Valve (Aortic and Mitral) Replacements with Transapical Transcatheter Implants – The Use of Transfemoral Devices
Author: Larry H Bernstein, MD, FCAP and Curator: Aviva Lev-Ari, PhD, RN
13.5 Tricuspid Valve
13.5.1 First-in-Man Mitral Valve Repairs Device used for Tricuspid Valve Repair: Cardioband used by University Hospital Zurich Heart Team
Reporter: Aviva Lev-Ari, PhD, RN
Chapter 14: Revolution in Technologies and Methods for Modification of the Original Anatomy of the Heart
Volume Summary by Justin D. Pearlman MD ME PhD MA FACC
Chapters 4-6 addressed clinical trial data in coronary disease, biomarkers of cardiovascular disorders, coagulation including top roles of nitric oxide, C-reative protein, protein C, aprotinin and thrombin). Chapters 7-8 covered amyloidosis, atherosclerosis, valve disease, flow reserve, atrial fibrillation and roles for advanced imaging. Chapters 9-10 covered unstable angina, transplants, and ventricular assist devices. Chapters 11-14 span interventions on the aorta, peripheral arteries, and coronary arteries, valve surgery and percutaneous valve repair or replacement, plus the growing role of prosthetics and repair by stem cells and tissue engineering.
EPILOGUE by Justin D. Pearlman MD ME PhD MA FACC
Thank you for joining us in coverage of basic and advanced status analysis, methods, outcomes, and future opportunities in cardiovascular disease diagnosis, mechanisms, impact and opportunities. Coverage includes trends in societal impact, and the basis for improvement in adverse events.
We use the present tense, because these are electronic documents that update periodically to stay fresh, so you can come back not only for review but also for updates.
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