Predictors of long-term survival after percutaneous aortic valvuloplasty: Report of the mansfield scientific balloon aortic valvuloplasty registry

AbstractPercutaneous balloon aortic valvuloplasty was used to prospectively treat 492 elderly, symptomatic, nonsurgical patients suffering from severe aortic stenosis in 27 centers in North America and Europe. At 1 year the overall survival rate was 64% and the event-free survival rate (survival free of valve replacement or repeat valvuloplasty) was 43%. Clinical, catheterization and procedural variables were assessed to define prognostic variables.Univariate analysis revealed that patients who survived had a lesser frequency of previous myocardial infarction (2% versus 6%, p < 0.005), lower incidence of severe ventricular dysfunction (22% versus 48%, p < 0.001) and lower incidence of symptoms of heart failure (60% versus 75%, p < 0.02). History of angina (56% versus 45%, p = NS) and syncope (23% versus 16%, p = NS) were similar for both groups. Values obtained at cardiac catheterization that differed in survivors and nonsurvivors included lower pulmonary artery systolic pressure (43 ± 1 versus 54 ± 2 mm Hg, p < 0.001), lower mean pulmonary artery pressure (28 ± 1.0 versus 36 ± 1.0 mm Hg, p < 0.001) and larger initial valve area (0.52 ± 0.01 versus 0.47 ± 0.02 cm2, p = 0.006).Discriminate function analysis was performed to identify variables that independently predicted improved probability of survival. Eight variables were significantly and independently predictive. These included age, initial cardiac output, initial left ventricular systolic pressures, initial left ventricular end-diastolic pressures, presence of coronary artery disease, New York Heart Association dyspnea classification, number of balloon inflations and final valve area. From this analysis, patient survival probabilities at 1 year varying between 80% and 20% could be calculated. Although both initial and final severity of aortic stenosis were prognostically important on univariate analysis, discriminant function analysis revealed that only final severity of aortic stenosis was prognostic.These observations suggest that subgroups of patients with lower or higher mortality rates can be identified after balloon aortic valvuloplasty. The presence of left ventricular dysfunction, the presence of coronary artery disease and the use of multiple balloon inflations adversely affect long-term prognosis. Conversely, effective valvuloplasty provides modest improvement in survival probability

Role of percutaneous transluminal coronary angioplasty in acute myocardial infarction

Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/26656/1/0000200.pd

Comparison of a New bioprosthetic Mitral Valve to Other Commercially Available Devices Under Controlled Conditions in a Porcine Mode

BACKGROUND/AIM: To evaluate three mitral bioprostheses (of comparable measured internal diameters) under controlled, stable, hemodynamic and surgical conditions by bench, echocardiographic, computerized tomography and autopsy comparisons pre‐ and postvalve implantation. METHODS: Fifteen similar‐sized Yorkshire pigs underwent preprocedural computerized tomography anatomic screening. Of these, 12 had consistent anatomic features and underwent implantation of a mitral bioprosthesis via thoracotomy on cardiopulmonary bypass (CPB). Four valves from each of three manufacturers were implanted in randomized fashion: 27‐mm Epic, 27‐mm Mosaic, and 25‐mm Mitris bioprostheses. After CPB, epicardial echocardiographic studies were performed to assess hemodynamic function and define any paravalvular leaks, followed by postoperative gated contrast computerized tomography. After euthanasia, animals underwent necropsy for anatomic evaluation. RESULTS: All 12 animals had successful valve implantation with no study deaths. Postoperative echocardiographic trans‐valve gradients varied among bioprosthesis manufacturers. The 25‐mm Mitris (5.1 ± 2.7)/(2.6 ± 1.3 torr) had the lowest peak/mean gradient and the 27‐mm Epic bioprosthesis had the highest (9.2 ± 3.7)/(4.6 ± 1.9 torr). Surgical valve opening area (SOA) varied with the 25‐mm Mitris having the largest SOA (2.4 ± 0.15 cm(2)) followed by the 27‐mm Mosaic (2.04 ± 0.23 cm(2)) and the 27‐mm Epic (1.8 ± 0.27 cm(2)) valve. Bench device orthogonal internal diameter measurements did not match manufacturer device size labeling: 25‐mm Mitris (23 × 23 mm), 27‐mm Mosaic (23 × 22 mm), 27‐mm Epic (21 × 21 mm). CONCLUSIONS: Current advertisement/packaging of commercial surgical mitral valves is not uniform. This study demonstrates marked variations in hemodynamics, valve opening area and anatomic dimensions between similar sized mitral bioprostheses. These data suggest a critical need for standardization and close scientific evaluation of surgical mitral bioprostheses to ensure optimal clinical outcomes

Caval-Aortic Access to Allow Transcatheter Aortic Valve Replacement in Otherwise Ineligible Patients Initial Human Experience

ObjectivesThis study describes the first use of caval-aortic access and closure to enable transcatheter aortic valve replacement (TAVR) in patients who lacked other access options. Caval-aortic access refers to percutaneous entry into the abdominal aorta from the femoral vein through the adjoining inferior vena cava.BackgroundTAVR is attractive in high-risk or inoperable patients with severe aortic stenosis. Available transcatheter valves require large introducer sheaths, which are a risk for major vascular complications or preclude TAVR altogether. Caval-aortic access has been successful in animals.MethodsWe performed a single-center retrospective review of procedural and 30-day outcomes of prohibitive-risk patients who underwent TAVR via caval-aortic access.ResultsBetween July 2013 and January 2014, 19 patients underwent TAVR via caval-aortic access; 79% were women. Caval-aortic access and tract closure were successful in all 19 patients; TAVR was successful in 17 patients. Six patients experienced modified VARC-2 major vascular complications, 2 (11%) of whom required intervention. Most (79%) required blood transfusion. There were no deaths attributable to caval-aortic access. Throughout the 111 (range 39 to 229) days of follow up, there were no post-discharge complications related to tract creation or closure. All patients had persistent aorto-caval flow immediately post-procedure. Of the 16 patients who underwent repeat imaging after the first week, 15 (94%) had complete closure of the residual aorto-caval tract.ConclusionsPercutaneous transcaval venous access to the aorta allows TAVR in otherwise ineligible patients, and may offer a new access strategy for other applications requiring large transcatheter implants