Jose Diez

Transcatheter aortic valve replacement using a self-expanding bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery

OBJECTIVES This study sought to evaluate the safety and efficacy of the CoreValve transcatheter heart valve (THV) for the treatment of severe aortic stenosis in patients at extreme risk for surgery. BACKGROUND Untreated severe aortic stenosis is a progressive disease with a poor prognosis. Transcatheter aortic valve replacement (TAVR) with a self-expanding bioprosthesis is a potentially effective therapy. METHODS We performed a prospective, multicenter, nonrandomized investigation evaluating the safety and efficacy of self-expanding TAVR in patients with symptomatic severe aortic stenosis with prohibitive risks for surgery. The primary endpoint was a composite of all-cause mortality or major stroke at 12 months, which was compared with a pre-specified objective performance goal (OPG). RESULTS A total of 41 sites in the United States recruited 506 patients, of whom 489 underwent attempted treatment with the CoreValve THV. The rate of all-cause mortality or major stroke at 12 months was 26.0% (upper 2-sided 95% confidence bound: 29.9%) versus 43.0% with the OPG (p < 0.0001). Individual 30-day and 12-month events included all-cause mortality (8.4% and 24.3%, respectively) and major stroke (2.3% and 4.3%, respectively). Procedural events at 30 days included life-threatening/disabling bleeding (12.7%), major vascular complications (8.2%), and need for permanent pacemaker placement (21.6%). The frequency of moderate or severe paravalvular aortic regurgitation was lower 12 months after self-expanding TAVR (4.2%) than at discharge (10.7%; p = 0.004 for paired analysis). CONCLUSIONS TAVR with a self-expanding bioprosthesis was safe and effective in patients with symptomatic severe aortic stenosis at prohibitive risk for surgical valve replacement. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902).

2-Year Outcomes After Iliofemoral Self-Expanding Transcatheter Aortic Valve Replacement in Patients With Severe Aortic Stenosis Deemed Extreme Risk for Surgery

BACKGROUND We reported favorable 1-year outcomes in patients unsuitable for surgery who underwent self-expanding transcatheter aortic valve replacement (TAVR) compared with an objective performance goal. Longer-term outcomes in these patients are not known. OBJECTIVES This study sought to evaluate the 2-year safety and efficacy in patients with severe aortic stenosis (AS) at extreme risk of surgery treated with self-expanding TAVR. METHODS We performed a prospective, multicenter, controlled, nonrandomized investigation of self-expanding TAVR in patients with severe AS and prohibitive surgical risk. We report the 2-year clinical outcomes in these patients. RESULTS A total of 489 extreme-risk patients were treated transfemorally with a self-expanding aortic bioprosthesis at 41 centers. The rate of all-cause mortality or major stroke was 38.0% at 2 years (all-cause mortality, 36.5%; major stroke, 5.1%). The rates of all-cause mortality, cardiovascular mortality, and major stroke were 36.6%, 26.2%, and 5.1%, respectively, at 2 years. Between 1 and 2 years, the incremental all-cause mortality, cardiovascular mortality, and major stroke rates were 12.3%, 7.9%, and 0.8%, respectively. Multivariable predictors of all-cause mortality at 2 years included the presence of coronary artery disease and admission from an assisted living center. A Society of Thoracic Surgeons score >15% was also predictive of 2-year all-cause mortality. At 2 years, 94% of patients had New York Heart Association functional class I or II symptoms. The frequency of moderate or severe paravalvular regurgitation (4.3% at 1 year; 4.4% at 2 years) was unchanged between the first and second year. CONCLUSIONS Patients with severe AS at extreme surgical risk treated with self-expanding TAVR continued to show good clinical outcomes and hemodynamic valve performance at 2 years. The presence of comorbid conditions rather than valve performance affected 2-year outcomes in these patients. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902).

Ticagrelor: the evidence for its clinical potential as an oral antiplatelet treatment for the reduction of major adverse cardiac events in patients with acute coronary syndromes.

Introduction: Ticagrelor, the first direct-acting, reversibly binding oral P2Y12 receptor antagonist, appears to have a favorable efficacy and safety profile. Aims: To update the evidence and provide an overview of the available data on ticagrelor. Evidence review: Peer reviewed articles published and listed under Medline Search, and published updated guidelines for pharmacotherapies in acute coronary syndromes were reviewed. Place in therapy: Clinical evidence is increasing to support the use of new thienopyridines and the direct-acting P2Y12 receptor in the setting of acute coronary syndromes. Conclusion: The options for drugs to inhibit the platelet P2Y12 receptor for adenosine diphosphate are rapidly expanding. Ticagrelor has shown benefits in clinical trials. Its rapid onset of platelet inhibition and short half-life make it an attractive alternative to thienopyridines, especially when rapid inhibition of platelet aggregation or its quick reversal are required.

Practical Strategies for the Management of Anticoagulation Therapy: Unsolved Issues in the Cardiac Catheterization Laboratory

PurposePercutaneous coronary intervention (PCI) is the preferred reperfusion strategy in the management of patients with ST-elevation myocardial infarction (STEMI) and higher-risk patients with unstable angina/non-STEMI (UA/NSTEMI). Recent updates have been issued for guidelines from the American College of Cardiology and American Heart Association delineating the appropriate use of anticoagulants as ancillary therapies to PCI. This manuscript reviews the recent clinical trial data supporting the updated guidelines and highlights remaining areas of uncertainty.MethodsSCOPUS and Pubmed were searched for relevant English-language reports of clinical trials, registries, articles and case reports. Search terms included but were not limited to: PCI, anticoagulation, ancillary, STEMI, NSTEMI, angina, acute coronary syndrome. The reference lists of identified articles were searched for additional relevant publications.ResultsUnfractionated heparin (UFH), the historical standard of care for anticoagulation in STEMI and NSTEMI patients undergoing PCI, is sub-optimal and the list of anticoagulants recommended for alternatives in the current guidelines has expanded to include superior anticoagulants, including the low-molecular-weight heparin enoxaparin and the direct thrombin inhibitor bivalirudin. Additionally, fondaparinux is recommended if supplemented during PCI by an additional agent with anti-IIa activity.However, uncertainties in the guidelines remain. Clinical discretion is still required when deciding which anticoagulant to use, ensuring seamless transitions throughout the care pathway, and how to correctly identify the risk status of a patient and modify anticoagulant regimens accordingly, such as in special patient populations.ConclusionsThe published evidence supports the updates to the guidelines. Updated guidelines still have knowledge gaps which require the application of clinical discretion by the cardiologist.

Transcatheter Aortic Valve-in-Valve Replacement Instead of a 4th Sternotomy in a 21-Year-Old Woman with Aortic Homograft Failure.

Transcatheter aortic valve replacement (TAVR) is a well-established method for replacing native aortic valves; however, it was conceived for elderly patients with aortic valve stenosis, and the lack of data on long-term durability has led practitioners to restrict the use of TAVR to patients who have short life expectancies. Here, we describe the case of a 21-year-old woman who had undergone 3 previous open aortic valve replacements and who presented with symptoms of recurrent valvular failure. Transthoracic echocardiograms and computed tomographic angiograms revealed a degenerating aortic root homograft with substantial calcification, moderate-to-severe aortic valve stenosis, and severe aortic valve regurgitation. Open surgical valve replacement posed substantial risk to our patient, so we decided to perform valve-in-valve TAVR with use of the Edwards Sapien XT Transcatheter Heart Valve. The patients pulmonary artery pressure, valvular regurgitation, and symptoms improved substantially thereafter. We found that valve-in-valve TAVR into a failing aortic root homograft was less invasive than repeat surgical valve replacement in this young patient who had congenital vascular anomalies and a complex surgical history.

Incidencia de trombosis de stents coronarios en el ®mundo real¼

Antecedentes la evidencia disponible de stents liberadores de medicamento proviene de estudios controlados con estrictos criterios de inclusion, limitando sus conclusiones y haciendo dificil la aplicacion de sus resultados en el mundo real. Objetivo determinar la incidencia de trombosis de stents liberadores y no liberadores de medicamento en pacientes del «mundo real». Metodologia estudio de incidencia para determinar el numero de casos de trombosis de stents implantados, mediante informacion obtenida a partir de historias clinicas, bases de datos y seguimiento clinico, y con base en caracteristicas demograficas, factores de riesgo, consumo de clopidogrel y casos de trombosis del stent con un seguimiento de cero dias a un ano. Resultados 640 stents implantados (69,2% no medicados, 30,8% medicados de los cuales 18,9% eran medicados con placlitaxel y 11,9% medicados con sirolimus). Se identificaron doce eventos de trombosis (siete stents medicados y cinco no medicados). La incidencia de trombosis con cualquier tipo de stent fue de 1,88% (IC 95% 0,97–3,28). La incidencia de trombosis con stent medicado fue 3,55% (IC 95% 1,43–7,32), y con stent no medicado 1,13% (IC 95% 0,37–2,64) p =0,000. El riesgo relativo de trombosis con stent medicado es de 3,14 (IC 95% 1,01–9,78) p=0,037. El riesgo relativo de presentar trombosis con stent medicado en infarto agudo del miocardio es 8,11 (IC 95% 2,32–28,31) p=0,001. Conclusiones la incidencia de trombosis del stent aumenta en el mundo real, y existe mayor riesgo de trombosis de stents medicados especialmente cuando son implantados en el contexto de un infarto agudo del miocardio. Es necesario realizar estudios futuros que involucren una poblacion de pacientes mas amplia y con seguimiento a largo plazo.