Publications (78) View all
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Article: Transcatheter Aortic Valve Replacement With the SAPIEN 3: A New Balloon-Expandable Transcatheter Heart Valve.
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ABSTRACT: The aim of this study was to demonstrate the first-in-human feasibility and short-term clinical outcomes with a new balloon-expandable transcatheter heart valve (THV). The SAPIEN 3 (S3) THV incorporates a paravalvular sealing system, an active 3-dimensional coaxial positioning catheter, and is compatible with a 14-F expandable sheath. The S3 THV was implanted in 15 patients with symptomatic severe aortic stenosis via femoral arterial access. Multidetector computed tomography before and after valve implantation allowed assessment of a novel annular area sizing algorithm. Clinical and echocardiographic data were obtained at baseline, discharge, and 30 days. All 15 device implants were successful. Multidetector computed tomography estimated an aortic annular area of 4.9 ± 0.4 cm(2), predicting 9.7 ± 6.9% THV oversizing. Post-transcatheter aortic valve replacement multidetector computed tomography showed consistently symmetrical and circular THVs. Aortic valve area increased from 0.7 ± 0.2 cm(2) to 1.5 ± 0.2 cm(2) (p < 0.001), and mean transaortic gradient decreased from 42.2 ± 10.3 mm Hg to 11.9 ± 5.3 mm Hg (p < 0.001). No patient had more than mild paravalvular aortic regurgitation. Hospital discharge occurred at a median of 3 (range 2 to 12) hospital days. At 30 days there were no deaths, strokes, vascular complications, bleeds, or transfusions, although 1 patient (6.7%) required a new pacemaker. All patients were in New York Heart Association functional class I or II. The S3 THV and delivery system might facilitate fully percutaneous implantation in a broader range of patients with the potential for more accurate positioning and less paravalvular regurgitation.03/2013; 6(3):293-300. · 1.07 Impact Factor -
Article: Transcatheter aortic valve replacement with a new self-expanding transcatheter heart valve and motorized delivery system.
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ABSTRACT: The aim of this study was to demonstrate feasibility and short- and midterm clinical outcomes with a new self-expanding transcatheter heart valve and motorized delivery system. Refining transcatheter aortic valve replacement with newly designed bioprostheses and delivery systems is anticipated to facilitate the procedure, reduce the risk of complications, improve outcomes, and widen applicability. The CENTERA valve (Edwards Lifesciences, Irvine, California) was implanted in 15 patients with symptomatic severe aortic stenosis via femoral or axillary arterial percutaneous access. Patients underwent transesophageal echocardiography during and transthoracic echocardiography and multidetector computed tomography before and after valve implantation. Clinical and echocardiographic follow-up was obtained at 30 days and for the initial 10 patients after 1 year. All 15 device implants were successful. Aortic valve area increased from 0.7 ± 0.1 cm(2) to 1.6 ± 0.4 cm(2) post-procedure (p < 0.01) and 1.8 ± 0.3 cm(2) at 1 year. Mean transaortic gradient decreased from 36.3 ± 14.2 mm Hg to 10.6 ± 5.4 mm Hg post-procedure (p < 0.001) and 10.8 ± 4.1 mm Hg at 1 year. Paravalvular aortic regurgitation at 30-day follow-up was none/trivial in 3 (23%), mild in 9 (69%), and moderate in 1 (8%) patient. Four patients (27%) received a new permanent pacemaker. Survival was 87% at 30 days and 80% at 1 year. All surviving patients were in New York Heart Association functional class I (25%) or II (75%) at 1 year. Transcatheter aortic valve replacement with the CENTERA transcatheter heart valve and motorized delivery system is feasible and can lead to good short- and midterm clinical and hemodynamic outcomes.03/2013; 6(3):301-7. · 1.07 Impact Factor -
Article: Cardiovascular Risk among Stable Individuals Suspected of Having Coronary Artery Disease with No Modifiable Risk Factors: Results from an International Multicenter Study of 5262 Patients.
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ABSTRACT: Purpose:To assess the prevalence, extent, severity, and risk of coronary artery disease (CAD) in patients suspected of having CAD but with no medically modifiable risk factors.Materials and Methods:Institutional review board approval or waiver of consent was obtained at each center. This study was HIPAA compliant. From an international multicenter cohort study of 27 125 subjects undergoing coronary computed tomographic (CT) angiography from 12 centers, 5262 patients without known CAD and without modifiable risk factors were identified. CAD severity was defined as none (0%), mild (1%-49%), or obstructive (≥50%) on a per-patient, per-vessel, and per-segment basis. CAD presence, extent, and severity were related to incidence of major adverse cardiovascular event (MACE) by using Cox proportional hazards models.Results:At a mean follow-up of 2.3 years ± 1.2 (standard deviation), MACE occurred in 106 patients. CAD was common for nonobstructive (n = 1452, 27%) and obstructive (n = 629, 12%) CAD. In risk-adjusted analysis, per-patient obstructive CAD (hazard ratio [HR], 6.64; 95% confidence interval [CI]: 3.68, 12.00; P ≤ .001) was related to MACE. MACE was associated with a dose-response relationship to the number of vessels exhibiting obstructive CAD, increasing risk for obstructive one-vessel (HR, 6.11; 95% CI: 3.22, 11.6; P ≤ .001), two-vessel (HR, 5.86; 95% CI: 2.75, 12.5; P ≤ .0001), or three-vessel or left main (HR, 11.69; 95% CI: 5.38, 25.4; P ≤ .001) CAD. The increased hazard for MACE of obstructive disease holds true for symptomatic (HR, 11.9; 95% CI: 4.81, 29.6; P ≤ .001) and asymptomatic (HR, 6.3; 95% CI: 2.4, 16.7; P ≤ .001) patients. No CAD at coronary CT angiography was associated with a low annualized MACE rate: 0.31% versus 2.06% with obstructive disease.Conclusion:Among individuals suspected of having CAD but without modifiable risk factors, CAD is common, with significantly increased hazards for MACE and mortality.© RSNA, 2013.Radiology 02/2013; · 5.73 Impact Factor -
Article: Reply: beneficial effects of angiotensin receptor blockade in chronic obstructive pulmonary disease.
American Journal of Respiratory and Critical Care Medicine 02/2013; 187(3):328. · 11.08 Impact Factor -
Article: Determination of the Aortic Annulus Plane in CT Imaging-A Step-by-Step Approach.
JACC. Cardiovascular imaging 02/2013; 6(2):275-278. · 14.29 Impact Factor
