Abstract Background Significant paravalvular leak (PVL) after surgical valve replacement can result in intractable congestive heart failure and hemolytic anemia. Because repeat surgery is performed ...in only few patients, transcatheter reduction of PVL is emerging as an alternative option, but its safety and efficacy remain uncertain. In this study we sought to assess whether a successful transcatheter PVL reduction is associated with an improvement in clinical outcomes. Methods We identified 12 clinical studies that compared successful and failed transcatheter PVL reductions in a total of 362 patients. A Bayesian hierarchical meta-analysis was performed using cardiac mortality as a primary end point. The combined occurrence of improvement in New York Heart Association functional class or hemolytic anemia and the need for repeat surgery, were used as secondary end points. Results A successful transcatheter PVL reduction was associated with a lower cardiac mortality rate (odds ratio OR, 0.08; 95% credible interval CrI, 0.01-0.90) and with a superior improvement in functional class or hemolytic anemia, compared with a failed intervention (OR, 9.95; 95% CrI, 2.10-66.73). Fewer repeat surgeries were also observed after successful procedures (OR, 0.08; 95% CrI, 0.01-0.40). Conclusions A successful transcatheter PVL reduction is associated with reduced all-cause mortality and improved functional class in patients deemed unsuitable for surgical correction.
.1241 Preamble This document has been developed as an Expert Consensus Document (ECD) by the American College of Cardiology Foundation (ACCF), American Association for Thoracic Surgery (AATS), ...Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons in collaboration with the American Heart Association (AHA), American Society of Echocardiography, European Association for Cardio-Thoracic Surgery, Heart Failure Society of America, Society of Cardiovascular Computed Tomography, Society of Cardiac Magnetic Resonance, Society of Cardiovascular Anesthesiologists, and Mended Hearts. Often the topic is the subject of considerable ongoing investigation. ...the reader should view the ECD as the best attempt of the ACCF and document cosponsors to inform and guide clinical practice in areas where rigorous evidence may not yet be available or evidence to date is not widely applied to clinical practice. Conference calls of the writing committee were confidential and attended only by committee members.\n AR = aortic regurgitation AS = aortic stenosis AVA = aortic valve area AVR = aortic valve replacement CAD = coronary artery disease CMR = cardiac magnetic resonance COPD = chronic obstructive pulmonary disease CT = computed tomography EF = ejection fraction EOA = effective orifice area EuroSCORE = European system for cardiac operative risk evaluation LV = left ventricular LVOT = left ventricular outflow pact MDCT = multidetector computed tomography NCDR = National Cardiovascular Data Registry PARTNER = Placement of Aortic Transcatheter Valve trial PH = pulmonary hypertension RV = right ventricular SOURCE = SAPIEN Aortic Biosprosthesis European Outcome registry STS = Society of Thoracic Surgeons TAVR = transcatheter aortic valve replacement TEE = transesophageal echocardiogram TTE = transthoracic echocardiography VARC = Valve Academic Research Consortium * This table represents the relationships of reviewers with industry and other entities that were disclosed at the time of peer review and determined to be relevant. A person is deemed to have a significant interest in a business if the interest represents ownership of >=5% of the voting stock or share of the business entity, or ownership of >=$10,000 of the fair market value of the business entity; or if funds received by the person from the business entity exceed 5% of the person's gross income for the previous year. Names are listed in alphabetical order within each category of review.According to the ACCF/AHA, a person has a relevant relationship IF: a) the relationship or interest relates to the same or similar subject matter, intellectual property or asset, topic, or issue addressed in the document; or b) the company/entity (with whom the relationship exists) makes a drug, drug class, or device addressed in the document, or makes a competing drug or device addressed in the document; or c) the person or a member of the person's household, has a reasonable potential for financial, professional or other personal gain or loss as a result of the issues/content addressed in the document.AATS indicates American Association for Thoracic Surgery; ACCF, American College of Cardiology Foundation; ACE, Accreditation for Cardiovascular Excellence; AHA, American Heart Association; ASE, American Society of Echocardiography; DCRI, Duke Clinical Research Institute; EACTS, European Association for Cardio-Thoracic Surgery; HFSA, Heart Failure Society of America; NCDR-CARE, National Cardiovascular Data Registry-Carotid Artery Revascularization and Endarterectomy; NIH, National Institutes of Health; PARTNER, Placement of Aortic Transcatheter Valve Trial; PI, principal investigator; SCA, Society of Cardiovascular Anesthesiologists; SCAI, Society for Cardiovascular Angiography and Interventions; SCCT, Society of Cardiovascular Computed Tomography; SCMR, Society for Cardiovascular Magnetic Resonance; and STS, Society of Thoracic Surgeons.
Objectives The purpose of this study was to evaluate the feasibility and efficacy of the percutaneous device closure of a consecutive series of patients with periprosthetic paravalvular leaks ...referred to our structural heart disease center with congestive heart failure and hemolytic anemia. Background Clinically significant periprosthetic paravalvular leak is an uncommon but serious complication after surgical valve replacement. Percutaneous closure has been utilized as an alternative to surgical repair of this defect in high-risk surgical patients. Methods This is a retrospective review of 57 percutaneous paravalvular leak closures that were performed in 43 patients (67% male, mean age 69.4 ± 11.7 years) between April 2006 and September 2010. Integrated imaging modalities were used for the evaluation, planning, and guidance of the interventions. Results Closure was successful in 86% of leaks and in 86% of patients. Twenty-eight of 35 patients improved by at least 1 New York Heart Association functional class. The percentage of patients requiring blood transfusions and/or erythropoietin injections post-procedure decreased from 56% to 5%. Clinical success was achieved in 89% of the patients in whom procedure was successful. The survival rates for patients at 6, 12, and 18 months after paravalvular leak closures were 91.9%, 89.2%, and 86.5%, respectively. Freedom from cardiac-related death at 42 months post-procedure was 91.9%. Conclusions Percutaneous closure of symptomatic paravalvular leaks, facilitated by integrated imaging modalities has a high rate of acute and long-term success and appears to be effective in managing symptoms of heart failure and hemolytic anemia.
ACC/AHA Task Force Members Jeffrey L. Anderson, MD, FACC, FAHA, Chair, Jonathan L. Halperin, MD, FACC, FAHA, Chair-Elect, Nancy M. Albert, PhD, CCNS, CCRN, FAHA, Biykem Bozkurt, MD, PhD, FACC, FAHA, ...Ralph G. Brindis, MD, MPH, MACC, Mark A. Creager, MD, FACC, FAHA§§Task Force member during the writing effort., Lesley H. Curtis, PhD, FAHA, David DeMets, PhD, Robert A. Guyton, MD, FACC§§, Judith S. Hochman, MD, FACC, FAHA, Richard J. Kovacs, MD, FACC, FAHA, E. Magnus Ohman, MD, FACC, Susan J. Pressler, PhD, RN, FAHA, Frank W. Sellke, MD, FACC, FAHA, Win-Kuang Shen, MD, FACC, FAHA, William G. Stevenson, MD, FACC, FAHA§§, Clyde W. Yancy, MD, FACC, FAHA§§ Table of Contents Preamble... An organized and directed approach to a thorough review of evidence has resulted in the production of clinical practice guidelines that assist clinicians in selecting the best management strategy for an individual patient. ...clinical practice guidelines can provide a foundation for other applications, such as performance measures, appropriate use criteria, and both quality improvement and clinical decision support tools. ...in view of the increasing number of comparative effectiveness studies, comparator verbs and suggested phrases for writing recommendations for the comparative effectiveness of one treatment or strategy versus another are included for COR I and IIa, LOE A or B only.\n Charney Division of Cardiology; Associate Director, Health Care Center None None None None None None Craig R. Smith Content Reviewer Columbia University College of Physicians and Surgeons--Professor of Surgery; Chair, Department of Surgery; New York-Presbyterian Hospital/Columbia University Medical Center--Surgeon-in-Chief None None None Edwards Lifesciences--PI None None Ruth H. Strasser Content Reviewer--AIG Heart Centre,University Hospital, University of Technology, Dresden--Professor, Director, and Chair, Internal Medicine and Cardiology Clinic; Medical Director, Heart Centre None None None None Abbottdagger AstraZenecadagger Bayerdagger Biosensorsdagger Pfizerdagger None Rakesh Suri Content Reviewer Mayo Clinic--Associate Professor of Surgery None None None None Edwards Lifesciencesdagger Sorindagger St. Jude Medicaldagger None Vinod Thourani Content Reviewer--Surgeon Council Emory University Edward Lifesciences Sorin St. Jude Medical None Apica Cardiovasculardagger Maquet None None Alec Vahanian Content Reviewer Hospital Bichat--Department de Cardiologie Abbott Vascular Edwards Lifesciences Medtronic St. Jude Medical Valtech None None None None None Andrew Wang Content Reviewer Duke University Medical Center--Professor of Medicine None None None Abbott Vascularlow * Edwards Lifescienceslow * None Defendant, Sudden death, 2012 * This table represents the relationships of reviewers with industry and other entities that were disclosed at the time of peer review and determined to be relevant to this document. Names are listed in alphabetical order within each category of review.According to the ACC/AHA, a person has a relevant relationship IF: a) The relationship or interest relates to the same or similar subject matter, intellectual property or asset, topic, or issue addressed in the document; or b) The company/entity (with whom the relationship exists) makes a drug, drug class, or device addressed in the document, or makes a competing drug or device addressed in the document; or c) The person or a member of the person's household, has a reasonable potential for financial, professional or other personal gain or loss as a result of the issues/content addressed in the document.AATS indicates American Association for Thoracic Surgery; ACC, American College of Cardiology; AHA, American Heart Association; AIG, Association of International Governors; ASE, American Society of Echocardiography; DSMB, Data and Safety Monitoring Board; MRI, magnetic resonance imaging; NIH, National Institutes of Health; NYU, New York University; PARTNERS, Placement Of Aortic Transcatheter Valves; PI, Principal Investigator; SCA, Society of Cardiovascular Anesthesiologists; SCAI, Society for Cardiovascular Angiography and Interventions; STS, Society of Thoracic Surgeons; and VA, Veterans Affairs.
2012 ACCF/AATS/SCAI/STS expert consensus document on transcatheter aortic valve replacement Holmes, David R., MD, FACC; Mack, Michael J., MD, FACC; Kaul, Sanjay, MBBS, FACC ...
Journal of thoracic and cardiovascular surgery/The Journal of thoracic and cardiovascular surgery/The journal of thoracic and cardiovascular surgery,
09/2012, Letnik:
144, Številka:
3
Journal Article
Abstract The human glial-cell derived neurotrophic factor (hGDNF) gene transfer by neurotensin (NTS)-polyplex nanoparticles functionally restores the dopamine nigrostriatal system in experimental ...Parkinson's disease models. However, high levels of sustained expression of GDNF eventually can cause harmful effects. Herein, we report an improved NTS-polyplex nanoparticle system that enables regulation of hGDNF expression within dopaminergic neurons. We constructed NTS-polyplex nanoparticles containing a single bifunctional plasmid that codes for the reverse tetracycline-controlled transactivator advanced (rtTA-Adv) under the control of NBRE3x promoter, and for hGDNF under the control of tetracycline-response element (TRE). Another bifunctional plasmid contained the enhanced green fluorescent protein (GFP) gene. Transient transfection experiments in N1E-115-Nurr1 cells showed that doxycycline (100 ng/mL) activates hGDNF and GFP expression. Doxycycline (5 mg/kg, i.p.) administration in rats activated hGDNF expression only in transfected dopaminergic neurons, whereas doxycycline withdrawal silenced transgene expression. Our results offer a specific doxycycline-regulated system suitable for nanomedicine-based treatment of Parkinson's disease.
Abstract The VARC (Valve Academic Research Consortium) for transcatheter aortic valve replacement set the standard for selecting appropriate clinical endpoints reflecting safety and effectiveness of ...transcatheter devices, and defining single and composite clinical endpoints for clinical trials. No such standardization exists for circumferentially sutured surgical valve paravalvular leak (PVL) closure. This document seeks to provide core principles, appropriate clinical endpoints, and endpoint definitions to be used in clinical trials of PVL closure devices. The PVL Academic Research Consortium met to review evidence and make recommendations for assessment of disease severity, data collection, and updated endpoint definitions. A 5-class grading scheme to evaluate PVL was developed in concordance with VARC recommendations. Unresolved issues in the field are outlined. The current PVL Academic Research Consortium provides recommendations for assessment of disease severity, data collection, and endpoint definitions. Future research in the field is warranted.
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