Assessment of Coronary Artery Obstruction Risk During Transcatheter Aortic Valve Replacement Utilising 3D-Printing.

BACKGROUND: Current imaging techniques may inadequately rule out coronary artery obstruction (CAO), a potentially fatal complication during transcatheter aortic valve replacement (TAVR). Advancements in three-dimensional (3D)-printing allow the development of models capable of replicating cardiac anatomy and predicting CAO. We sought to simulate TAVR utilising 3D-printed cardiac models to improve CAO risk assessment and procedural safety. METHODS: Thirteen (13) patients with aortic stenosis at high-risk of CAO during TAVR were selected for 3D-printed modelling. The relevant anatomy for TAVR was precisely reconstructed with Materialise Heart Print-Flex (Materialse, Leuven, Belgium) technology. An appropriately sized valve prosthesis was deployed in each 3D-model and coronary ostia assessed for obstruction. RESULTS: Model-derived results were compared to clinical outcomes in 13 cases. One high-risk case underwent TAVR resulting in left main obstruction and subsequent stenting. This outcome was accurately predicted by the 3D-model simulation. Two (2) high-risk TAVR cases were abandoned following transient CAO during balloon aortic valvuloplasty (BAV). The 3D-model simulations correlated with these findings, demonstrating CAO either by a calcium nodule or the native valve leaflet. In another two cases, BAV was uncertain, however the 3D-simulation demonstrated patency and successful TAVR was undertaken. In remaining cases, no obstruction was demonstrated in-vitro, and all underwent uncomplicated TAVR. CONCLUSIONS: In this proof-of-concept study, 3D-model TAVR simulation correlates well to clinical outcomes. 3D-models of patients at high-risk of CAO may be utilised in pre-procedural planning to accurately predict this complication. As lower-risk surgical cohorts are considered for TAVR, 3D-models may minimise complications leading to safer patient outcomes.

First-in-man transfemoral transcatheter aortic valve replacement with the 29 mm Edwards SAPIEN XT valve.

OBJECTIVES: 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. BACKGROUND: TAVR has undergone significant advances in device technology resulting in smaller profile sheaths and delivery systems, allowing transfemoral delivery of a 29 mm valve. METHODS: 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. RESULTS: 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 < 0.001). There were two major vascular complications; however, there were no in-hospital or 30-day neurological events, need for pacemaker insertion, or mortality. CONCLUSIONS: Transfemoral TAVR with the 29 mm Edwards SAPIEN XT valve and Novaflex + delivery system through a 20F expandable sheath was feasible with acceptable short-term outcomes.

Oversizing in transcatheter aortic valve replacement, a commonly used term but a poorly understood one: dependency on definition and geometrical measurements.

BACKGROUND: In transcatheter aortic valve replacement, prosthesis oversizing is essential to prevent paravalvular regurgitation. However, the estimated extent of oversizing strongly depends on the measurement used for annular sizing. PURPOSE: The aim was to investigate the influence of geometrical parameters for calculation of relative oversizing in transcatheter aortic valve replacement, reported as percentage in relation to the native annulus size, to standardize reporting. METHODS: Electrocardiogram-gated cardiac dual-source CT data of 130 consecutive patients with severe aortic stenosis (mean age, 81 ± 8 years; 56 men; mean aortic valve area, 0.67 ± 0.18 cm2) were included. Aortic annulus dimensions were quantified by means of planimetry that yielded area and perimeter at the level of the basal attachment points of the aortic cusps during systole. Area- and perimeter-derived diameters were calculated as DA = 2 × âˆš(A/π) and DP = P/π. Hypothetical prosthesis sizing was based on DA (23-mm prosthesis for 19-22 mm; 26-mm prosthesis for 22-25 mm; 29-mm prosthesis for 25-28 mm). Relative oversizing for hypothetical prosthesis selection was calculated as percentage in relation to the native annulus size. RESULTS: Mean annulus area was 492.12 ± 94.9 mm2 and mean perimeter was 80.1 ± 7.6 mm. DP was significantly larger than DA (25.5 ± 2.4 mm vs 24.9 ± 2.4 mm; P < .001). Mean maximum diameter was 28.1 ± 3.0 mm and mean minimal diameter was 22.8 ± 2.4 mm. Calculated eccentricity index [EI = 1 - minimal diameter/maximum diameter)] was 0.19 ± 0.06. Difference between DP and DA correlated significantly with EI (r = 0.67; P < .001). Relative oversizing was 10.2% ± 3.8% and 21.6% ± 8.4% by DA and area, and 7.8% ± 3.9% by both DP and perimeter. CONCLUSION: For planimetric assessment of aortic annulus dimensions with CT, the percentage oversizing calculated strongly depends on the geometrical variable used for quantifying annular dimensions. Standardized nomenclature seems warranted for comparison of future studies.

Transcatheter aortic valve replacement with a new self-expanding transcatheter heart valve and motorized delivery system.

OBJECTIVES: 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. BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Transcatheter aortic valve replacement with the SAPIEN 3: a new balloon-expandable transcatheter heart valve.

OBJECTIVES: 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). BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Impact of post-implant SAPIEN XT geometry and position on conduction disturbances, hemodynamic performance, and paravalvular regurgitation.

OBJECTIVES: This report sought to study the impact of the balloon-expandable SAPIEN XT (Edwards Lifesciences, Irvine, California) transcatheter heart valve (THV) stent frame geometry and position on outcomes of transcatheter aortic valve replacement (TAVR). BACKGROUND: Post-implant THV geometry and position might impact atrioventricular conduction, hemodynamic performance, and annular sealing. METHODS: Eighty-nine consecutive patients who underwent TAVR with a Sapien XT THV had pre- and post-implant multidetector computed tomography, transthoracic echocardiography, and electrocardiograms performed to assess THV stent geometry, atrioventricular conduction, and hemodynamic performance. RESULTS: The THV Circularity (THV eccentricity <10% [eccentricity = minimum stent diameter/maximum stent diameter]) and under-expansion (THV area/nominal THV area <90%) were present in 97.8% (2 of 89) and 0%, respectively. Low THV implantation was associated with new left bundle branch block and complete heart block (3.4 ± 2.0 mm vs. 5.5 ± 2.9 mm, p = 0.01) and with the need for permanent pacemaker implantation (3.5 ± 2.0 mm vs. 7.1 ± 2.5 mm, p = 0.001). In contrast, labeled THV size and THV area oversizing was not associated with atrioventricular conduction disturbances. The relation between inflow stent frame area and annular area was related to paravalvular regurgitation (p = 0.025). Labeled prosthesis size but not prosthesis expansion or eccentricity was related to valve gradient (p = 0.005) and effective orifice area (p < 0.001). CONCLUSIONS: Low implantation depth of balloon-expandable THVs is associated with clinically significant new conduction disturbances and permanent pacemaker implantation. Importantly, annular area oversizing was not associated with these complications.

Multidetector CT predictors of prosthesis-patient mismatch in transcatheter aortic valve replacement.

BACKGROUND: Prosthesis-patient mismatch (PPM) is a predictor of mortality after aortic valve replacement (AVR). OBJECTIVE: We examined whether accurate 3-dimensional annular sizing with multidetector CT (MDCT) is predictive of PPM after transcatheter AVR (TAVR). METHODS: 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. RESULTS: 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 < .001; AUC, 0.66). CONCLUSIONS: PPM is frequent after TAVR. Appropriate annular oversizing does not reduce the rate or severity of PPM. Patient annulus size mismatch, identified by indexed MDCT annular area, is a significant predictor of PPM.

The impact of integration of a multidetector computed tomography annulus area sizing algorithm on outcomes of transcatheter aortic valve replacement: a prospective, multicenter, controlled trial.

OBJECTIVES: This study prospectively investigated the impact of integration of a multidetector computed tomography (MDCT) annular area sizing algorithm on transcatheter aortic valve replacement (TAVR) outcomes. BACKGROUND: Appreciation of the 3-dimensional, noncircular geometry of the aortic annulus is important for transcatheter heart valve (THV) sizing. METHODS: Patients being evaluated for TAVR in 4 centers underwent pre-procedural MDCT. Recommendations for balloon-expandable THV size selection were based on an MDCT sizing algorithm with an optimal goal of modest annulus area oversizing (5% to 10%). Consecutive patients who underwent TAVR with the algorithm (MDCT group) were compared with consecutive patients without the algorithm (control group). The primary endpoint was the incidence of more than mild paravalvular regurgitation (PAR), and the secondary endpoint was the composite of in-hospital death, aortic annulus rupture, and severe PAR. RESULTS: Of 266 patients, 133 consecutive patients underwent TAVR (SAPIEN XT THV) in the MDCT group and 133 consecutive patients were in the control group. More than mild PAR was present in 5.3% (7 of 133) of the MDCT group and in 12.8% (17 of 133) in the control group (p = 0.032). The combined secondary endpoint occurred in 3.8% (5 of 133) of the MDCT group and in 11.3% (15 of 133) of the control group (p = 0.02), driven by the difference of severe PAR. CONCLUSIONS: The implementation of an MDCT annulus area sizing algorithm for TAVR reduces PAR. Three-dimensional aortic annular assessment and annular area sizing should be considered for TAVR.

Percutaneous aortic valve replacement: vascular outcomes with a fully percutaneous procedure.

OBJECTIVES: The aim of this study was to evaluate vascular complications in a consecutive patient population undergoing transfemoral percutaneous aortic valve replacement (PAVR) applying current Valve Academic Research Consortium definitions. BACKGROUND: Vascular complications have been the major cause of mortality and morbidity associated with PAVR. Both open surgical and fully percutaneous access site strategies have been advocated. METHODS: All patients undergoing transfemoral PAVR during fiscal years 2009 and 2010 were prospectively evaluated at baseline, after the procedure, and at 30 days. RESULTS: PAVR was performed in 137 consecutive patients. All but 1 patient underwent planned arteriotomy closure using a percutaneous pre-closure technique. Smaller sheaths, rigorous angiographic and computed tomographic screening and patient selection, and percutaneous vascular repair techniques were increasingly used over this period. From 2009 to 2010, major vascular complications decreased from 8% to 1% (p = 0.06), minor vascular complications decreased from 24% to 8% (p < 0.01), major bleeds fell from 14% to 1% (p < 0.01), and unplanned surgery decreased from 28% to 2% (p < 0.01). A minimal artery diameter smaller than the external sheath diameter, moderate or severe calcification, and peripheral vascular disease were associated with higher vascular complication rates. CONCLUSIONS: Vascular complications occur more often if the minimal artery diameter is smaller than the external sheath diameter, in the presence of moderate or severe calcification, and in patients with peripheral vascular disease. With careful patient selection, advanced interventional techniques, and a fully percutaneous procedure, marked reductions in vascular and bleeding complications can be achieved.

Structural integrity of balloon-expandable stents after transcatheter aortic valve replacement: assessment by multidetector computed tomography.

OBJECTIVES: This study sought to evaluate the structural integrity of balloon-expandable stents used in transcatheter aortic valve replacement. BACKGROUND: Underexpansion, deformation, or fracture of stent frames may affect transcatheter heart valve (THV) function and durability. METHODS: 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 <90% (multidetector computed tomography derived external valve area/nominal external valve area). Echocardiography was performed after implantation and annually. RESULTS: Fifty patients underwent multidetector computed tomography at an average of 2.5 ± 0.9 years after transcatheter aortic valve replacement (35 Sapien, 8 Sapien XT, and 7 Cribier-Edwards valves [all Edwards Lifesciences, Irvine, California). The mean external diameter for the 23- and 26-mm valves was 23.3 ± 0.9 mm and 25.9 ± 0.9 mm, respectively. Circularity was present in 96% (48 of 50) and median eccentricity was 2.0% (interquartile range: 1.2% to 3.0%). Mean THV expansion was 104.1 ± 7.4%, which increased from stent inflow to outflow (100.8 ± 7.6% vs. 108.1 ± 6.9%, p < 0.001). Stent fracture was not observed. Underexpanded valves (8% [4 of 50]) and noncircular valves (4% [2 of 50]) demonstrated stable hemodynamic function on annual echocardiography. CONCLUSIONS: Balloon-expandable aortic valves have excellent rates of circularity with low eccentricity and maintain full expansion without stent fracture at an average 2.5 years after implantation.

Computed tomography-based sizing recommendations for transcatheter aortic valve replacement with balloon-expandable valves: Comparison with transesophageal echocardiography and rationale for implementation in a prospective trial.

BACKGROUND: Computed tomography (CT) annular measurements are predictive of paravalvular regurgitation after transcatheter aortic valve replacement (TAVR) which is a predictor of mortality and morbidity. OBJECTIVES: To demonstrate the rationale and potential implications of new CT sizing recommendations for TAVR. METHODS: The CT sizing recommendations aim to ensure routine transcatheter heart valve (THV) oversizing of the aortic annular area [(THV external area/systolic annular area - 1) × 100; range, 1%-20%; target, 10%-15%]. Consecutive patients (n = 120) underwent CT before TAVR with balloon-expandable valves sized by transesophageal echocardiography (TEE). Retrospectively, the CT-recommended THV size was compared with the actual size implanted. RESULTS: Compared with TEE, application of the newly developed CT-based sizing recommendations would have led to implantation of a larger valve in 33.3% (40/120), no change in valve size in 55.8% (67/120), and a smaller valve in 10.8% (13/120). In patients when CT recommended a larger valve, the incidence of at least moderate paravalvular regurgitation was 25% (10/40) compared with 4.5% (3/67; P < 0.01) when both TEE and CT recommendations were in agreement. Using diastolic versus systolic CT measurements results in 20% of patients receiving smaller THVs. TEE sizing resulted in 33.3% (40/120) of valves being undersized (THV area < CT systolic annular area) with a mean annular oversizing of 9.4% ± 17.4% (range: -21.5% to 65.9%) without annular rupture. In contrast, the CT sizing recommendations results in mean annular oversizing of 13.9% ± 8.0% (range, 1.3%-29.8%). CONCLUSION: These CT sizing recommendations enable standardized moderate overexpansion of the aortic annulus. Clinical outcomes from these recommendations are being prospectively assessed in a multicenter trial.

Sex differences in mortality after transcatheter aortic valve replacement for severe aortic stenosis.

OBJECTIVES: The aim of this study was to examine sex differences in outcome after transcatheter aortic valve replacement (TAVR) with real-world data from 2 large centers in Canada. BACKGROUND: Transcatheter aortic valve replacement is an effective alternative to surgical valve replacement in symptomatic patients with severe aortic stenosis, but the impact of sex on outcomes remains unclear. The PARTNER (Placement of Aortic Transcatheter Valves) 1A trial demonstrated greater benefit of TAVR over surgery in women, but whether this was due to the poorer surgical outcome of women or better TAVR outcome, compared with men, is unknown. METHODS: Consecutive patients (n = 641) undergoing TAVR in Vancouver and Quebec City, Canada, were evaluated. Differences in all-cause mortality were examined with Kaplan-Meier estimates, adjusted logistic regression, and proportional hazards models. RESULTS: Women comprised 51.3% of the cohort. Balloon-expandable valves were used in 97% of cases, with transapical approach in 51.7 % women and 38.1% men. Women had more major vascular complications (12.4% vs. 5.4%, p = 0.003) and borderline significantly more major/life-threatening bleeds (21.6% vs. 15.8%, p = 0.08). At baseline, women had higher aortic gradients and worse renal function but better ejection fractions. Men had more comorbidities: prior myocardial infarction, prior revascularization, and chronic obstructive pulmonary disease. The adjusted odds ratio for 30-day all-cause mortality favored women, 0.39 (95% confidence interval: 0.19 to 0.80; p = 0.01), and this benefit persisted for 2 years, hazard ratio 0.60 (95% confidence interval: 0.41 to 0.88; p = 0.008). CONCLUSIONS: Female sex is associated with better short- and long-term survival after TAVR. Added to the PARTNER 1A findings, these results suggest TAVR might be the preferred treatment option for elderly women with symptomatic severe aortic stenosis.

Transcatheter valve-in-valve implantation for failed balloon-expandable transcatheter aortic valves.

OBJECTIVES: This study sought to evaluate outcomes after implantation of a second transcatheter heart valve (THV-in-THV) for acute THV failure. BACKGROUND: Aortic regurgitation after transcatheter aortic valve replacement (TAVR) may be valvular due to prosthetic leaflet dysfunction or paravalvular due to poor annular sealing. METHODS: Patients undergoing aortic balloon-expandable TAVR at 3 centers were prospectively evaluated at baseline, intraprocedurally, at hospital discharge, and annually. RESULTS: Of 760 patients undergoing TAVR, 21 (2.8%) received a THV-in-THV implant due to acute, severe regurgitation. Aortic regurgitation was paravalvular in 18 patients and transvalvular in the remaining 3 patients. THV-in-THV implantation was technically successful in 19 patients (90%) and unsuccessful in 2 patients (10%), who subsequently underwent open heart surgery. Mortality at 30 days and 1 year was 14.3% and 24%, respectively. After successful THV-in-THV, mean aortic valve gradient fell from 37 ± 12 mm Hg to 13 ± 5 mm Hg (p < 0.01); aortic valve area increased from 0.64 ± 0.14 cm(2) to 1.55 ± 0.27 cm(2) (p < 0.01); and paravalvular aortic regurgitation was none in 4 patients, mild in 13 patients, and moderate in 2 patients. At 1-year follow-up, 1 patient had moderate and the others had mild or no paravalvular leaks. The mean transvalvular gradient was 15 ± 4 mm Hg, which was higher than in patients undergoing conventional TAVR (11 ± 4 mm Hg, p = 0.02). CONCLUSIONS: THV-in-THV implantation is feasible and results in satisfactory short- and mid-term outcomes.

Transcatheter aortic valve replacement with the St. Jude Medical Portico valve: first-in-human experience.

OBJECTIVES: The purpose of this study was to demonstrate the feasibility and procedural outcomes with a new self-expanding and repositionable transcatheter heart valve. BACKGROUND: Transcatheter aortic valve replacement is a viable option for selected patients with severe symptomatic aortic stenosis. However, suboptimal prosthesis positioning may contribute to paravalvular regurgitation, atrioventricular conduction block, and mitral or coronary compromise. METHODS: The repositionable Portico valve (St. Jude Medical, Minneapolis, Minnesota) was implanted in 10 patients with severe aortic stenosis utilizing percutaneous femoral arterial access. Patients underwent transthoracic and transesophageal echocardiography and multidetector computed tomography before and after valve implantation. Clinical and echocardiographic follow-up was obtained at 30 days. RESULTS: Device implantation was successful in all patients. Prosthesis recapture and repositioning was performed in 4 patients. Intermittent prosthetic leaflet dysfunction in 1 patient required implantation of a second transcatheter valve. There was 1 minor stroke. At 30-day follow-up, echocardiographic mean transaortic gradient was reduced from 44.9 ± 16.7 mm Hg to 10.9 ± 3.8 mm Hg (p < 0.001), and valve area increased from 0.6 ± 0.1 cm(2) to 1.3 ± 0.2 cm(2) (p < 0.001). Paravalvular regurgitation was mild or less in 9 patients (90%) and moderate in 1 patient (10%). There were no major strokes, major vascular complications, major bleeds, or deaths. No patient required pacemaker implantation. All patients were in New York Heart Association functional class II or less. CONCLUSIONS: Transcatheter aortic valve replacement with the repositionable Portico transcatheter heart valve is feasible, with good short-term clinical and hemodynamic outcomes.

3-dimensional aortic annular assessment by multidetector computed tomography predicts moderate or severe paravalvular regurgitation after transcatheter aortic valve replacement: a multicenter retrospective analysis.

OBJECTIVES: This study sought to analyze multidetector computed tomography (MDCT) 3-dimensional aortic annular dimensions for the prediction of paravalvular aortic regurgitation (PAR) following transcatheter aortic valve replacement (TAVR). BACKGROUND: Moderate or severe PAR after TAVR is associated with increased morbidity and mortality. METHODS: A total of 109 consecutive patients underwent MDCT pre-TAVR with a balloon expandable aortic valve. Differences between transcatheter heart valve (THV) size and MDCT measures of annular size (mean diameter, area, and circumference) were analyzed concerning prediction of PAR. Patients with THV malposition (n = 7) were excluded. In 50 patients, MDCT was repeated after TAVR to assess THV eccentricity (1 - short diameter/long diameter) and expansion (MDCT measured THV area/nominal THV area). RESULTS: Moderate or severe PAR (13 of 102) was associated with THV undersizing (THV diameter - mean diameter = -0.7 ± 1.4 mm vs. 0.9 ± 1.8 mm for trivial to mild PAR, p < 0.01). The difference between THV size and MDCT annular size was predictive of PAR (mean diameter: area under the curve [AUC]: 0.81, 95% confidence interval [CI]: 0.68 to 0.88; area: AUC: 0.80, 95% CI: 0.65 to 0.90; circumference: AUC: 0.76, 95% CI: 0.59 to 0.91). Annular eccentricity was not associated with PAR (AUC: 0.58, 95% CI: 0.46 to 0.75). We found that 35.3% (36 of 102) and 45.1% (46 of 102) of THVs were undersized relative to the MDCT mean diameter and area, respectively. THV oversizing relative to the annular area was not associated with THV eccentricity or underexpansion (oversized vs. undersized THVs; expansion: 102.7 ± 5.3% vs. 106.1 ± 5.6%, p = 0.03; eccentricity: median: 1.7% [interquartile range: 1.4% to 3.0%] vs. 1.7% [interquartile range: 1.1% to 2.7%], p = 0.28). CONCLUSIONS: MDCT-derived 3-dimensional aortic annular measurements are predictive of moderate or severe PAR following TAVR. Oversizing of THVs may reduce the risk of moderate or severe PAR.

Transcatheter aortic valve replacement: outcomes of patients with moderate or severe mitral regurgitation.

OBJECTIVES: The aim of this study was to evaluate the impact of mitral regurgitation (MR) on outcomes after transcatheter aortic valve replacement (TAVR) and the impact of TAVR on MR. BACKGROUND: Little is known of the influence of MR on outcomes after TAVR. METHODS: The outcomes of patients with mild or less (n = 319), moderate (n = 89), and severe (n = 43) MR were evaluated after TAVR at 2 Canadian centers. RESULTS: Patients with moderate or severe MR had a higher mortality rate than those with mild or less MR during the 30 days after TAVR (adjusted hazard ratio: 2.10; 95% confidence interval: 1.12 to 3.94; p = 0.02). However, the mortality rates after 30 days were similar (adjusted hazard ratio: 0.82; 95% confidence interval: 0.50 to 1.34; p = 0.42). One year after TAVR, moderate MR had improved in 58%, remained moderate in 17%, and worsened to severe in 1%, and 24% of patients had died. Severe MR had improved in 49% and remained severe in 16%, and 35% of patients had died. Multivariate predictors of improved MR at 1 year (vs. unchanged MR, worse MR, or death) were a mean transaortic gradient ≥ 40 mm Hg, functional (as opposed to structural) MR, the absence of pulmonary hypertension, and the absence of atrial fibrillation. CONCLUSIONS: Moderate or severe MR in patients undergoing TAVR is associated with a higher early, but not late, mortality rate. At 1-year follow-up, MR was improved in 55% of patients with moderate or severe MR at baseline. Improvement was more likely in patients with high transaortic gradients, with functional MR, without pulmonary hypertension and without atrial fibrillation.

Transcatheter valve-in-valve implantation for failed surgical bioprosthetic valves.

When bioprosthetic cardiac valves fail, reoperative valve replacement carries a higher risk of morbidity and mortality compared with initial valve replacement. Transcatheter heart valve implantation may be a viable alternative to surgical aortic valve replacement for high-risk patients with native aortic stenosis, and valve-in-valve (V-in-V) implantation has been successfully performed for failed surgical bioprostheses in the aortic, mitral, pulmonic, and tricuspid positions. Despite some core similarities to transcatheter therapy of native valve disease, V-in-V therapy poses unique clinical and anatomic challenges. In this paper, we review the challenges, selection criteria, techniques, and outcomes of V-in-V implantation.

Outcomes and complications of transcatheter aortic valve replacement using a balloon expandable valve according to the Valve Academic Research Consortium (VARC) guidelines.

AIMS: There is heterogeneity in the reporting of procedural outcomes and complications following transcatheter aortic valve replacement (TAVR). Recently, new definitions have been proposed by the Valve Academic Research Consortium (VARC) in an effort to standardise these outcomes and improve the quality of future clinical research. The aim of this study is to report the procedural outcomes and complication rates following TAVR in a large sequential patient cohort using a balloon expandable valve according to the new VARC definitions. METHODS AND RESULTS: Three hundred and ten consecutive patients undergoing TAVR were assessed, including patients forming our early historical series at the infancy of TAVR. All complication rates were re-evaluated according to VARC definitions. Mean age was 82.2 ± 8.1 years and the Society of Thoracic Surgeons score was 9.4 ± 5.7%. Transfemoral 30-day mortality was 6.8% (3.8% in the second half of the cohort) and transapical 30-day mortality was 13.7% (9.4% in the second half of the cohort). Cardiovascular 30-day mortality was 7.4% and the composite safety endpoint at 30-days was 18.4%. Device success was 80% (post-procedural valve area ≤ 1.2 cm2 in 9.7%). Failure to deliver and deploy a valve occurred in only 3.5%, with 82% (nine cases) occurring in the first half of the experience. Of those who did not meet echocardiographic criteria for device success (valve area ≤ 1.2 cm2, transaortic gradient ≥ 20 mmHg or ≥ moderate aortic incompetence), 90% achieved a New York Heart Association class I/II. Life threatening bleeding complications occurred in 8.4%. In 7.7% of patients, red blood cell transfusions were given without evidence of overt bleeding. Major strokes occurred in 2.3% and acute kidney injury occurred in 6.5%. CONCLUSIONS: The VARC consensus guidelines provide a standardised reporting framework for clinical endpoints and complications post TAVR. We report the first series to our knowledge of 30-day outcomes using these definitions utilising a balloon expandable valve system.

Aortic annulus diameter determination by multidetector computed tomography: reproducibility, applicability, and implications for transcatheter aortic valve implantation.

OBJECTIVES: This study sought to determine the most reproducible multidetector computed tomography (MDCT) measurements of the aortic annulus and to determine methods to improve the applicability of these measurements for transcatheter aortic valve implantation. BACKGROUND: The reproducibility and applicability of MDCT annular measurements to guide transcatheter aortic valve implantation remain unclear. METHODS: Annular measurements were performed in 50 patients planed for transcatheter aortic valve implantation in multiple planes: basal ring (short- and long-axis, mean diameter, area-derived diameter), coronal, sagittal, and 3-chamber projections. A theoretical model was developed taking into account the differences between the most reproducible MDCT measurements and transesophageal echocardiography to guide valve size choice. RESULTS: The most reproducible measurements were the area-derived diameter and basal ring average diameter (inter-reader intraclass correlation coefficient: 0.87 [95% confidence interval: 0.81 to 0.92] and 0.80 [95% confidence interval: 0.70 to 0.87]; respectively; intrareader >0.90 for all readers). These were generally larger than transesophageal echocardiography diameters (mean difference of 1.5 ± 1.6 mm and 1.1 ± 1.7 mm, respectively). When a strategy of valve-sizing is undertaken using these CT measurements using an echocardiographic sizing scale, a different THV size would be selected in 44% and 40% of cases, respectively. When adjusting the sizing cutoffs to account for the differences in observed diameters, this was reduced to 10% to 12% (p < 0.01 for both, respectively). CONCLUSIONS: The most reproducible MDCT measurements of the annulus are the area-derived diameter and basal ring average diameter, with derived values generally larger than those obtained with echocardiography. If MDCT is used for valve sizing, a strategy incorporating these differences may be important. MDCT using these easily derived measurements may be ideally suited to sizing transcatheter aortic valves as they account for the eccentricity of the aortic annulus, are reproducible, and are noninvasive.

Door-to-balloon times are reduced in ST-elevation myocardial infarction by emergency physician activation of the cardiac catheterisation laboratory and immediate patient transfer.

OBJECTIVES: To assess whether a collaborative interdepartmental pathway involving emergency department (ED) physicians activating the cardiac catheterisation laboratory (CCL) with immediate patient transfer to the CCL reduces door-to-balloon (DTB) times for patients with suspected ST-elevation myocardial infarction (STEMI). DESIGN, SETTING AND PARTICIPANTS: A quasi-experimental before-and-after observational study using a prospective database, supplemented by chart review, of consecutive patients transferred from the ED to the CCL for suspected STEMI, from January 2007 to October 2009, at Sir Charles Gairdner Hospital, an adult tertiary-care hospital, Western Australia. MAIN OUTCOMES MEASURES: Median DTB time and proportion of patients with DTB time of < 90 minutes. Secondary outcomes, based on analysis of predefined subgroups, included door-to-activation time, activation-to-balloon time and false-positive activations of the CCL. RESULTS: Two hundred and thirty-four patients underwent emergency coronary angiography for suspected STEMI, with 188 (80%) undergoing percutaneous coronary intervention (118 before and 70 after implementation of the new pathway). Following implementation of the new pathway, median DTB time reduced from 97 to 77 minutes (P < 0.001), median door-to-activation time from 28 to 15 minutes (P = 0.002) and median activation-to-balloon time from 66 to 53 minutes (P < 0.001). The proportion of patients with recommended DTB time of < 90 minutes increased from 41% to 77% (P < 0.001) with no change in false positive CCL activation rates (12% v 11%; P = 0.38). CONCLUSION: ED physician activation of CCL with immediate patient transfer is associated with highly significant improvements in DTB time without increased false positive rates.