Objectives This study sought to assess the impact of baseline left ventricular (LV) outflow, LV ejection fraction (LVEF), and transvalvular gradient on outcomes following transcatheter aortic valve ...replacement (TAVR) in patients with severe aortic stenosis (AS). Background Low flow (i.e., reduced stroke volume index SVi) can occur with both reduced and preserved LVEF. Low flow is often associated with low gradient despite severe stenosis and with worse outcomes following surgical aortic valve replacement. However, there are few data about the impact of low flow on outcomes following TAVR. Methods We retrospectively analyzed the clinical, Doppler-echocardiographic, and outcome data prospectively collected in 639 patients who underwent TAVR for symptomatic severe AS in 2 Canadian centers. Results In this cohort, 334 (52.3%) patients had a low flow (SVi <35 ml/m2 ) and these patients had increased 30-day mortality (11.4 vs. 5.9%, p = 0.01), 2-year all-cause mortality (35.3 vs. 30.9%, p = 0.005), and 2-year cardiovascular mortality (25.7 vs. 16.8%, p = 0.01) compared with patients with normal flow. Reduced flow was an independent predictor of 30-day mortality (odds ratio: 1.94, p = 0.026), cumulative all-cause mortality (hazard ratio: 1.27 per 10 ml/m² SVi decrease, p = 0.016), and cumulative cardiovascular mortality (hazard ratio: 1.29 per 10 ml/m² decrease, p = 0.04). Despite significant association in univariable analyses, low LVEF and low mean gradient were not found to be independent predictors of outcomes in multivariable analyses. Conclusions Low flow but not low LVEF or low gradient is an independent predictor of early and late mortality following TAVR in high-risk patients with severe AS. SVi should be integrated in the risk stratification process of these patients.
Objectives 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. Background 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. Methods 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. Results 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). Conclusions 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.
Objectives This study was undertaken to compare the hemodynamic performance of a percutaneous bioprosthesis to that of surgically implanted (stented and stentless) bioprostheses for the treatment of ...severe aortic stenosis. Methods Fifty patients who underwent percutaneous aortic valve implantation (PAVI) with the Cribier-Edwards or Edwards SAPIEN bioprosthetic valve (Edwards Lifesciences, Inc., Irvine, California) were matched 1:1 for sex, aortic annulus diameter, left ventricular ejection fraction, body surface area, and body mass index, with 2 groups of 50 patients who underwent surgical aortic valve replacement (SAVR) with a stented valve (Edwards Perimount Magna SAVR-ST group), or a stentless valve (Medtronic Freestyle, Medtronic, Minneapolis, Minnesota SAVR-SL group). Doppler echocardiographic data were prospectively obtained before the intervention, at discharge, and at 6- to 12-month follow-up. Results Mean transprosthetic gradient at discharge was lower (p < 0.001) in the PAVI group (10 ± 4 mm Hg) compared with the SAVR-ST (13 ± 5 mm Hg) and SAVR-SL (14 ± 6 mm Hg) groups. Aortic regurgitation (AR) occurred more frequently in the PAVI group (mild: 42%, moderate: 8%) compared with the SAVR-ST (mild: 10%, moderate: 0%) and SAVR-SL (mild: 12%, moderate: 0%) groups (p < 0.0001). At follow-up, the mean gradient in the PAVI group remained lower (p < 0.001) than that of the SAVR-ST group, but was similar to that of the SAVR-SL group. The incidence of severe prosthesis-patient mismatch was significantly lower (p = 0.007) in the PAVI group (6%) compared with the SAVR-ST (28%) and SAVR-SL (20%) groups. However, the incidence of AR remained higher (p < 0.0001) in the PAVI group compared with the 2 other groups. Conclusions PAVI provided superior hemodynamic performance compared with the surgical bioprostheses in terms of transprosthetic gradient and prevention of severe prosthesis-patient mismatch, but was associated with a higher incidence of AR.
Objectives This study sought to: 1) determine the incidence, degree, and timing of the rise in serum cardiac markers of myocardial injury associated with uncomplicated transcatheter aortic valve ...implantation (TAVI); and 2) evaluate the predictive factors and prognostic value of myocardial injury associated with TAVI. Background Very few data exist on the occurrence and clinical relevance of myocardial injury during TAVI procedures. Methods A total of 101 patients who underwent successful TAVI (transfemoral TF approach, n = 38; transapical TA approach, n = 63) were included. Creatine kinase-MB (CK-MB) and cardiac troponin T (cTnT) levels were determined at baseline and at 6 to 12, 24, 48, and 72 h following TAVI. Results TAVI was associated with some degree of myocardial injury in 99% of the patients (TF: 97%, TA: 100%) as determined by a rise in cTnT (maximal value, 0.48 μg/l, interquartile range IQR: 0.24 to 0.82 μg/l) and in 77% of the patients (TF: 47%, TA: 95%) as determined by a rise in CK-MB (maximal value, 18.6 μg/l; IQR: 11.0 to 27.4 μg/l). TA approach and baseline renal dysfunction were associated with a higher increase in biomarkers of myocardial injury (p < 0.01 for both). A larger myocardial injury was associated with a smaller improvement of left ventricular ejection fraction (LVEF) (p < 0.01). The degree of rise in cTnT was an independent predictor of cardiac mortality at 9 ± 10 months of follow-up (hazard ratio: 1.14 per each increase of 0.1 μg/l, 95% confidence interval: 1.02 to 1.28, p = 0.028). Conclusions TAVI was systematically associated with some degree of myocardial injury, with TA approach and baseline renal dysfunction determining a higher increase in biomarkers of myocardial injury. A greater degree of myocardial injury was associated with less improvement in LVEF and a higher cardiac mortality at follow-up.
Objectives This study sought to determine the efficacy of low rate fluoroscopy at 7.5 frames/s (FPS) versus conventional 15 FPS for reduction of operator and patient radiation dose during diagnostic ...coronary angiography (DCA) and percutaneous coronary intervention (PCI) via the transradial approach (TRA). Background TRA for cardiac catheterization is potentially associated with increased radiation exposure. Low rate fluoroscopy has the potential to reduce radiation exposure. Methods Patients undergoing TRA diagnostic angiography ± ad-hoc PCI were randomized to fluoroscopy at 7.5 FPS versus 15 FPS prior to the procedure. Both 7.5 and 15 FPS fluoroscopy protocols were configured with a fixed dose per pulse of 40 nGy. Primary endpoints were operator radiation dose (measured with dosimeter attached to the left side of the thyroid shield in μSievert μSv), patient radiation dose (expressed as dose-area product in Gy·cm2 ), and fluoroscopy time. Results From October 1, 2012 to August 30, 2013, from a total of 363 patients, 184 underwent DCA and 179 underwent PCI. Overall, fluoroscopy at 7.5 FPS compared with 15 FPS was associated with a significant reduction in operator dose (30% relative reduction RR, p < 0.0001); and in patient's dose-area product (19% RR; p = 0.022). When stratified by procedure type, 7.5 FPS compared with 15 FPS was associated with significant reduction in operator dose during both DCA (40% RR; p < 0.0001) and PCI (28% RR; p = 0.0011). Fluoroscopy at 7.5 FPS, compared with 15 FPS, was also associated with substantial reduction in patients' dose-area product during DCA (26% RR; p = 0.0018) and during PCI (19% RR; p = 0.13). Fluoroscopy time was similar in 7.5 FPS and 15 FPS groups for DCA (3.4 ± 2.0 min vs. 4.0 ± 4.7 min; p = 0.42) and PCI (11.9 ± 8.4 min vs. 13.3 ± 9.7 min; p = 0.57), respectively. Conclusions Fluoroscopy at 7.5 FPS, compared with 15 FPS, is a simple and effective method in reducing operator and patient radiation dose during TRA DCA and PCI.
Objectives To study the causes of and to develop a risk score for failure of transradial approach (TRA) for percutaneous coronary intervention (PCI). Background TRA-PCI failure has been reported in ...5% to 10% of cases. Methods TRA-PCI failure was categorized as primary (clinical reasons) or crossover failure. Multivariate analysis was performed to determine independent predictors of TRA-PCI failure, and an integer risk score was developed. Results From January to June 2010, TRA-PCI was attempted in 1,609 (97.3%) consecutive patients, whereas 45 (2.7%) had primary TRA-PCI failure. Crossover TRA-PCI failure occurred in 30 (1.8%) patients. Causes of primary TRA-PCI failure included chronic radial artery occlusion (11%), previous coronary artery bypass graft (27%), and cardiogenic shock (20%). Causes for crossover TRA-PCI failure included: inadequate puncture in 17 patients (57%); radial artery spasm in 5 (17%); radial loop in 4 (13%); subclavian tortuosity in 2 (7%); and inadequate guide catheter support in 2 (7%) patients. Female sex (odds ratio OR: 3.2; 95% confidence interval CI: 1.95 to 5.26, p < 0.0001), previous coronary artery bypass graft (OR: 6.1; 95% CI: 3.63 to 10.05, p < 0.0001), and cardiogenic shock (OR: 11.2; 95% CI: 2.78 to 41.2, p = 0.0011) were independent predictors of TRA-PCI failure. Risk score values from 0 to 7 predicted a TRA-PCI failure rate from 2% to 80%. Conclusions In a high-volume radial center, 2.7% of patients undergoing PCI are excluded from initial TRA on clinical grounds, whereas crossover to femoral approach is required in only 1.8% of the cases. A new simple clinical risk score is developed to predict TRA-PCI failure.
Abstract Background Data regarding the mid- to long-term cognitive trajectory of transcatheter aortic valve (TAVR) recipients are scarce. Objectives Changes in global cognition and specific cognitive ...domains up to 1 year post-TAVR were evaluated. Methods Fifty-one patients (median age 80.0 interquartile range: 72.0 to 85.0 years; 37% women) underwent TAVR and prospective assessment of cognitive function using the Montreal Cognitive Assessment (MoCA) at baseline, short-term (30 days), and 1 year post-TAVR. Processing speed and executive cognitive functions were further evaluated with the digit-symbol substitution test (DSST), Trail Making Tests (TMT), and verbal fluency tests at the same time points. Cognitive decline (CD) was determined by changes in mean scores and as a rate using practice-corrected reliable change index (RCI). Results The baseline mean total MoCA score was 22.71 ± 3.84. Twenty patients (39.2%) were considered cognitively impaired using a cutoff of <23 of 30 points. Mean total MoCA score improved at short-term post-TAVR and remained stable at 1 year (p = 0.022). On the basis of the RCI of total MoCA score, 4 patients (7.8%) presented with short-term CD, which persisted at 1 year in 1 patient (2.0%). Four patients (7.8%) exhibited cognitive improvement at 1 year, increasing to 15% among those with baseline cognitive impairment. No significant changes were observed over time in the mean DSST, TMT, and verbal fluency test scores. On the basis of the RCI, 10 of 40 patients (25%) presented with a reduction in performance of at least 1 test at 30 days that persisted at 1 year in 4 patients (10%). Conclusions TAVR was associated with global improvement in cognitive status, more pronounced among those with cognitive impairment pre-TAVR. However, early decline in some complex cognitive functions was observed in one-quarter of TAVR recipients, persisting at 1 year in 10% of patients.
The purpose of this study was to evaluate the feasibility and initial results of a multidisciplinary percutaneous aortic valve implantation (PAVI) program including the transfemoral approach (TFA) ...and the transapical approach (TAA). This was a prospective registry including all patients with symptomatic severe aortic stenosis who were evaluated for PAVI and those who finally underwent the procedure. All patients were considered very high risk or nonsurgical candidates, and an algorithm based on prespecified criteria was used to determine the most appropriate approach (TFA vs TAA) for each patient. The Edwards-Sapien valve was used in all cases, and all procedures were performed without cardiopulmonary bypass. A total of 29 consecutive patients were evaluated for PAVI, and 22 of them underwent the procedure (mean age 84 ± 7 years, predicted surgical mortality 26 ± 16%), with 11 patients selected for each approach. Reasons for selecting TAA rather than TFA were the following: small diameter and/or severe calcification of the iliofemoral arteries (4 patients), peripheral vascular disease (4 patients), porcelain aorta (2 patients), and horizontal ascending aorta (1 patient). Successful aortic valve implantation was obtained in 91% of the procedures, and procedural and 30-day mortality were 4.3% and 8.7%, respectively. There were no cases of myocardial infarction, vascular complications, or cerebrovascular accident. PAVI was associated with a significant reduction in mean aortic gradient (baseline 34 ± 10 mm Hg, postprocedure 9 ± 3 mm Hg, p <0.001), with no cases of severe aortic regurgitation. After a median follow-up period of 6 months, there were no additional major adverse cardiac events, and no significant changes in hemodynamic aortic valve parameters were observed. In conclusion, this study demonstrates the feasibility and low complication rate of a PAVI program using a prospective strategy for the selection of the TFA or TAA, with half of the patients selected for each approach.
Objectives The objectives were to compare different Doppler echocardiographic methods for the measurement of prosthetic valve effective orifice area (EOA) following transcatheter aortic valve ...implantation (TAVI) and to determine the factors influencing the EOA of transcatheter balloon expandable valves. Background Previous studies have used different methods for the measurement of the valve EOA following TAVI. Factors influencing the EOA of transcatheter valves are unknown. Methods A total of 122 patients underwent TAVI with the use of the Edwards-SAPIEN valve (Edwards Lifesciences, Irvine, California). The EOA was measured by transthoracic echocardiography at hospital discharge, 6 months and 1 year after TAVI with the use of 2 methods as described in previous studies. In Method #1 (EOA1 ), LVOT diameter (LVOTd) entered in the continuity equation was measured at the base of prosthesis cusps whereas, in Method #2 (EOA2 ), LVOTd was measured immediately proximal to the prosthesis stent. Results The average EOA2 (1.57 ± 0.41 cm2 ) was larger (p < 0.01) than the EOA1 (1.21 ± 0.38 cm2 ). Accordingly, incidence of severe PPM (indexed EOA ≤0.65 cm2 /m2 ) was 3-fold lower with the use of EOA2 than with EOA1 (9% vs. 33%; p < 0.001). Mean transprosthetic gradient correlated better (p = 0.03) with indexed EOA2 (r = −0.70, p < 0.0001) than with indexed EOA1 (r = −0.58, p < 0.0001). Intraobserver and interobserver variability were lower for EOA2 compared to EOA1 (intra: 5% vs. 7%, p = 0.06; inter: 6% vs. 14%; p < 0.001). Aortic annulus size was the sole independent determinant (p = 0.01) of prosthetic valve EOA2 . The average EOA varied from 1.37 ± 0.23 cm2 for aortic annulus size <19 mm up to 1.90 ± 0.17 cm2 for size >23 mm. Conclusions When estimating the EOA of Edwards-SAPIEN valves by Doppler-echocardiography, it is recommended to use the LVOT diameter and velocity measured immediately proximal to the stent. The main determinant of the EOA of transcatheter valves is the patient's annulus size and these valves provide excellent hemodynamics even in patients with a small aortic annulus.
Objectives Valve hemodynamics and clinical outcomes among patients with a small aortic annulus who underwent transcatheter aortic valve implantation (TAVI) were examined. Background The presence of a ...small aortic annulus may complicate the surgical management of patients with severe aortic stenosis (AS). TAVI is an alternative to aortic valve replacement (AVR) in high-risk patients, but few data exist on the results of TAVI in patients with a small aortic annulus. Methods Between 2007 and 2010, 35 patients (mean age 79.2 ± 9.4 years) with severe AS and an aortic annulus diameter <20 mm (mean 18.5 ± 0.9 mm) underwent TAVI with a 23-mm Edwards SAPIEN bioprosthesis (Edwards Lifesciences, Inc., Irvine, California). Echocardiographic parameters and clinical outcomes were assessed prior to discharge and at 6, 12, and 24 months. Results Procedural success was achieved in 34 patients (97.1%). There was 1 in-hospital death. Peak and mean transaortic gradients decreased from 76.3 ± 33.0 mm Hg and 45.2 ± 20.6 mm Hg at baseline to 21.8 ± 8.4 mm Hg and 11.7 ± 4.8 mm Hg post-procedure, respectively, both p < 0.0001. Mean indexed effective orifice area (IEOA) increased from 0.35 ± 0.10 cm2 /m2 at baseline to 0.90 ± 0.18 cm2 /m2 post-procedure, p < 0.0001. Severe prosthesis–patient mismatch (IEOA <0.65 cm2 /m2 ) occurred in 2 patients (5.9%). At a mean follow-up of 14 ± 11 months, gradients remained low and 30 of the 31 remaining survivors were in New York Heart Association functional class I or II. Conclusions In high-risk patients with severe AS and a small aortic annulus, TAVI is associated with good post-procedural valve hemodynamics and clinical outcomes. TAVI may provide a reasonable alternative to conventional AVR in elderly patients with a small aortic annulus.
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