The objective of this study was to compare the incidence of cerebral embolism (CE) as evaluated by diffusion-weighted magnetic resonance imaging (DW-MRI) following transapical (TA) transcatheter aortic valve implantation (TAVI) versus transfemoral (TF) TAVI.
The TA-TAVI approach avoids both the manipulation of large catheters in the aortic arch/ascending aorta and the retrograde crossing of the aortic valve, and this avoidance might lead to a lower rate of CE.
This was a prospective multicenter study including 60 patients who underwent cerebral DW-MRI the day before and within the 6 days following TAVI (TF approach: 29 patients; TA approach: 31 patients). Neurologic and cognitive function assessments were performed at DW-MRI time points.
The TAVI procedure was performed with the Edwards valve and was successful in all cases but one (98%). A total of 41 patients (68%) had 251 new cerebral ischemic lesions at the DW-MRI performed 4 ± 1 days after the procedure, 19 patients in the TF group (66%) and 22 patients in the TA group (71%; p = 0.78). Most patients (76%) with new ischemic lesions had multiple lesions (median number of lesions per patient: 3, range 1 to 31). There were no differences in lesion number and size between the TF and TA groups. No baseline or procedural factors were found to be predictors of new ischemic lesions. The occurrence of CE was not associated with a measurable impairment in cognitive function, but 2 patients (3.3%) had a clinically apparent stroke within the 24 h following the procedure (1 patient in each group).
TAVI is associated with a high rate of silent cerebral ischemic lesions as evaluated by DW-MRI, with no differences between the TF and TA approaches. These results provide important novel insight into the mechanisms of CE associated with TAVI and support the need for further research to both reduce the incidence of CE during these procedures and better determine their clinical relevance.
To demonstrate the feasibility of transfemoral transcatheter aortic valve replacement (TAVR) with the 29 mm Edwards SAPIEN XT valve and Novaflex™ + delivery system through a 20F expandable sheath (eSheath™, Edwards Lifesciences, USA). In addition, to describe the use of the Novaflex + delivery system and expandable sheath.
TAVR has undergone significant advances in device technology resulting in smaller profile sheaths and delivery systems, allowing transfemoral delivery of a 29 mm valve.
Twelve patients underwent transfemoral TAVR with the 29 mm Edwards SAPIEN XT valve and Novaflex + delivery system through a 20F expandable sheath. Baseline clinical and procedural characteristics are evaluated. In-hospital and 30-day outcomes are reported according to Valve Academic Research Consortium criteria.
All patients were male with a mean aortic annulus diameter of 25.0 ± 1.1 mm and 25.9 ± 1.2 mm, on transesophageal echocardiography and multidetector computerized tomography, respectively. Mean iliofemoral minimal luminal diameter (MLD) was 8.0 ± 0.8 mm. Successful deployment of the valve occurred in 11 out of 12 patients. Valve embolization occurred in one patient. Aortic valve area increased from 0.7 ± 0.2 to 2.0 ± 0.5 cm(2) (P
Comment In: Catheter Cardiovasc Interv. 2013 Oct 1;82(4):671-224078425
Prosthesis-patient mismatch (PPM) is a predictor of mortality after aortic valve replacement (AVR).
We examined whether accurate 3-dimensional annular sizing with multidetector CT (MDCT) is predictive of PPM after transcatheter AVR (TAVR).
One hundred twenty-eight patients underwent MDCT then TAVR. Moderate PPM was defined as an indexed effective orifice area =0.85 cm²/m² and severe =0.65 cm²/m². MDCT annular measurements (area, short and long axis) were compared with the size of the selected transcatheter heart valve (THV) to obtain (1) the difference between prosthesis size and CT-measured mean annular diameter and (2) the percentage of undersizing or oversizing (calculated as 100 × [MDCT annular area--THV nominal area]/THV nominal area). In addition, the MDCT annular area was indexed to body surface area. These measures were evaluated as potential PPM predictors.
We found that 42.2% of patients had moderate PPM and 9.4% had severe PPM. Procedural characteristics and in-hospital outcomes were similar between patients with or without PPM. THV undersizing of the mean aortic annulus diameter was not predictive of PPM (odds ratio [OR], 0.84; 95% CI, 0.65-1.07; P = .16; area under the receiver-operating characteristic curve [AUC], 0.58). THV undersizing of annular area was not predictive of PPM (OR, 0.96; 95% CI, 0.80-1.16; P = .69; AUC, 0.52). Indexed MDCT annular area was, however, predictive of PPM (OR, 0.24; 95% CI, 0.10-0.59; P
This study assessed whether multislice computed tomography (MSCT) could predict optimal angiographic projections for visualizing the plane of the native valve and facilitate accurate positioning during transcatheter aortic valve implantation (TAVI).
Accurate device positioning during TAVI depends on valve deployment in angiographic projections perpendicular to the native valve plane, but these may be difficult to determine.
Twenty patients underwent MSCT before TAVI. Using a novel technique, multiple angiographic projections accurately representing the native valve plane in multiple axes were determined. The accuracy of all predicted projections was determined post-procedure using angiography according to new criteria, based on valve perpendicularity and the degree of strut overlap (defined as excellent, satisfactory, or poor). The accuracy of valve deployment using MSCT was compared with the results of 20 consecutive patients undergoing TAVI without such MSCT angle prediction.
Correct final deployment projections were more frequent in the MSCT-guided compared with non-MSCT-guided group: excellent or satisfactory projections (90% vs. 65%, p = 0.06). The MSCT angle prediction was accurate but dependent on optimal images (optimal images: 93% of predicted angles were excellent or satisfactory, suboptimal images: 73% of predicted angles were poor). A "line of perpendicularity" could be generated with optimal projections across the right-to-left anterior oblique plane by adding the correct cranial or caudal angulation.
Pre-procedural MSCT can predict optimal angiographic deployment projections for implantation of transcatheter valves. An ideal deployment angle curve or "line of perpendicularity" can be generated. Understanding and applying these principles improves the accuracy of valve deployment and may improve outcomes.
This study aims to assess the mid- to long-term follow-up of patients after valve embolization at the time of transcatheter aortic valve implantation (TAVI).
Transcatheter heart valve (THV) embolization is a rare but serious complication during TAVI. Although various techniques have been developed to manage acute complications and reduce periprocedural morbidity/mortality, long-term clinical and hemodynamic consequences after these events are unknown.
Patients who developed THV embolization after TAVI were prospectively assessed. Clinical and echocardiographic characteristics were recorded at baseline and after successful TAVI/surgical aortic valve replacement. The THV migration and strut fractures/degeneration were assessed by computed tomography.
A total of 7 patients had THV embolization, all of which occurred immediately after valve deployment. The embolized THV was repositioned in the aortic arch proximal to the left subclavian artery (n = 2), immediately distal to the left subclavian artery (n = 2), and in the abdominal aorta (n = 3). A second THV was implanted successfully at the same sitting in 4 patients and at the time of a second procedure in 2 patients. Elective conventional aortic valve replacement was performed in 1 patient. Median follow-up was 1,085 days. One patient died during follow-up from an unrelated cause. The remaining 6 survivors were in New York Heart Association functional class I or II at final follow-up. Mid-term computed tomography follow-up (n = 4,591 to 1,548 days) showed that the leaflets of the embolized THV remain open in all phases of the cardiac cycle. There was also no strut fracture or migration of these valves.
Clinical outcomes remain good when THV embolization is managed effectively. There are no apparent hemodynamic consequences of a second valve placed in the series. These embolized valves remain in a stable position with no evidence of strut fractures at mid-term follow-up.
This study sought to evaluate the structural integrity of balloon-expandable stents used in transcatheter aortic valve replacement.
Underexpansion, deformation, or fracture of stent frames may affect transcatheter heart valve (THV) function and durability.
Patients >1 year after transcatheter aortic valve replacement underwent multidetector computed tomography. Geometry of the stent frame was assessed for circularity; eccentricity; minimum and maximum external diameter; and expansion at the inflow, mid-stent, and outflow levels, as well as for stent fracture. THV noncircularity was defined as stent eccentricity >10% (1 - minimum diameter/maximum diameter) and THV underexpansion when expansion
In transcatheter aortic valve replacement (TAVR), the influence of aortic annular assessment with either multidetector computed tomography (MDCT) or conventional transesophageal echocardiography (TEE) on the incidence of postprocedural paravalvular aortic regurgitation (PAR) was evaluated.
PAR remains a major limitation in TAVR. Appropriate selection of transcatheter heart valve (THV) size is crucial to prevent PAR.
Outcomes following TAVR with a balloon-expandable THV were compared in two retrospective cohorts identified according to whether THV size selection was based on TEE (study group 1, n = 80) or MDCT (study group 2, n = 58).
The two study groups were comparable with regard to baseline clinical, risk score, and echocardiographic characteristics. The incidence of moderate/severe PAR was lower in study group 2 than in group 1, 8.6% versus 28.8% (P
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
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