Search

Background: Initial data about the performance of the new-generation SAPIEN 3 Ultra (S3U) valve are highly promising. However, evidence about the longer-term performance and safety of the S3U is scarce., Aims: We aimed to investigate the 1-year clinical and echocardiographic outcomes of transcatheter aortic valve implantation (TAVI) using the S3U compared with its predecessor, the SAPIEN 3 valve (S3)., Methods: The SAPIEN 3 Ultra registry included consecutive patients who underwent transfemoral TAVI at 12 European centres with the S3U or S3 between October 2016 and December 2020. One-to-one propensity score (PS) matching was performed to account for differences in baseline characteristics. The primary outcomes of interest were all-cause death and the composite of all-cause death, disabling stroke and hospitalisation for heart failure at 1 year., Results: The overall study cohort encompassed 1,692 patients treated with either the S3U (n=519) or S3 (n=1,173). The PS-matched population had a total of 992 patients (496 per group). At 1 year, the rate of death from any cause was 4.9% in the S3U group and 6.3% in the S3 group (p=0.743). Similarly, there were no significant differences in the rates of the primary composite outcome (9.5% in the S3 group and 6.6% in the S3U group; p=0.162). The S3U was associated with lower rates of mild paravalvular leak (PVL) compared with the S3 (odds ratio 0.63, 95% confidence interval: 0.44 to 0.88; p<0.01). No significant differences in transprosthetic gradients were observed between the two groups., Conclusions: Compared with the S3, the S3U transcatheter heart valve was associated with similar 1-year clinical outcomes but reduced rates of mild PVL.

Background: Transcatheter aortic valve replacement (TAVR) with the ACURATE neo device has been associated with a non-negligible incidence of paravalvular aortic regurgitation (AR). The new-generation ACURATE neo2 has been designed to mitigate this limitation., Aims: The aim of the study was to compare TAVR with the ACURATE neo and neo2 devices., Methods: The NEOPRO and NEOPRO-2 registries retrospectively included patients undergoing transfemoral TAVR with self-expanding valves at 24 and 20 centres, respectively. Patients receiving the ACURATE neo and neo2 devices (from January 2012 to December 2021) were included in this study. Predischarge and 30-day VARC-3 defined outcomes were evaluated. The primary endpoint was predischarge moderate or severe paravalvular AR. Subgroup analyses per degree of aortic valve calcification were performed., Results: A total of 2,026 patients (neo: 1,263, neo2: 763) were included. Predischarge moderate or severe paravalvular AR was less frequent for the neo2 group (2% vs 5%; p<0.001), resulting in higher VARC-3 intended valve performance (96% vs 90%; p<0.001). Furthermore, more patients receiving the neo2 had none/trace paravalvular AR (59% vs 38%; p<0.001). The reduction in paravalvular AR with neo2 was mainly observed with heavy aortic valve calcification. New pacemaker implantation and VARC-3 technical and device success rates were similar between the 2 groups; there were more frequent vascular and bleeding complications for the neo device. Similar 1-year survival was detected after TAVR (neo2: 90% vs neo: 87%; p=0.14)., Conclusions: TAVR with the ACURATE neo2 device was associated with a lower prevalence of moderate or severe paravalvular AR and more patients with none/trace paravalvular AR. This difference was particularly evident with heavy aortic valve calcification.

Background/purpose: The MANTA is a dedicated plug-based large-bore vascular closure device (VCD) providing safe hemostasis in most patients, but data on the clinical impact and mechanisms of MANTA related complications are limited. This study sought to determine the frequency, impact and predictors of MANTA-related access complications., Methods/materials: This patient-level meta-analysis included data from 2 medical device approval studies and 1 post-approval registry. The primary endpoint was the composite of major and minor access complications. Technical success was defined as hemostasis with MANTA closure device without need for vascular surgery or stenting., Results: Eight hundred ninety-one patients (mean age 80) underwent transcatheter aortic valve replacement (n = 814), endovascular aortic repair (n = 71), balloon aortic valvuloplasty (n = 4) or mechanical circulatory support (n = 2). Technical success was 96.4% and median time to hemostasis was 31 (interquartile range: 17-76) seconds. The primary endpoint occurred 9.1% and bailout vascular surgery or stenting was necessary in 32 patients (3.6%). Female gender (OR: 2.63, CI: 1.46-4.73, p = 0.001), left femoral access (OR: 2.18, CI: 1.17-4.06, p = 0.015) and unfavorable arteriotomy phenotype (combination of a small femoral artery diameter with a deep arteriotomy; OR 2.27: 1.26-4.10, p = 0.006) independently predicted access complications. Access complications most often consisted of vessel dissection, stenosis or occlusion and predominantly occurred in patients with an unfavorable arteriotomy phenotype., Conclusions: Large-bore arteriotomy closure with MANTA VCD provided fast and safe hemostasis with an acceptable complication rate. Refined procedure planning and risk-stratification may further improve MANTA VCD performance., Competing Interests: Declaration of competing interest Dr. Van Mieghem received research grants from Teleflex. Other authors have nothing to declare., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

Objectives: To report on the experience with a selective prophylactic permanent pacemaker (PPx-PPM) implantation strategy in patients with pre-existing right bundle branch block (RBBB) undergoing transcatheter aortic valve replacement (TAVR)., Background: Pre-existing RBBB is an independent predictor for PPM after TAVR and has been linked to increased mortality., Methods: Hospital patient flow and longer-term clinical endpoints were compared for TAVR patients with pre-existing RBBB treated in a period with and without selective PPx-PPM strategy (2013-2020)., Results: A total of 260 patients were included: 170 in the early period without PPx-PPM strategy and 90 patients in the late period with selective PPx-PPM strategy. A PPx-PPM was implanted in 44% of patients in the late period. Overall, 69% versus 80% of all patients in the early versus late period ended up with a PPM (p = .06). Streamlined transfemoral TAVR was routinely used from 2017-in this series of patients, both TAVR procedural time and hospital length of stay (LoS) were significantly shorter in the late versus early period (mean procedural time: 70 vs. 83 min and LoS ≥5 days: 15% vs. 40%; p < .05). No difference in all-cause/cardiovascular mortality was observed between both strategies, whereas cardiac rehospitalization was significantly higher for patients treated in the early versus late period (hazard ratio 2.33 [1.04-5.26]; p = .042)-this mainly due to (sub)acute PPM-implantation early after discharge., Conclusions: Selective prophylactic PPM implantation in TAVR candidates with pre-existing RBBB results in shorter TAVR procedural time and hospital LoS and prevents early cardiac rehospitalization related to complete heart block., (© 2021 Wiley Periodicals LLC.)

Background: Elevated pulmonary artery pressure (PAP) in patients with severe aortic stenosis (AS) is a strong predictor of adverse prognosis. This study sought to assess the relation between PAP and clinical and echocardiographic parameters in elderly patients with severe AS, as well as to identify the determinants of the change in PAP after transcatheter aortic valve implantation (TAVI)., Methods: The study included 170 subjects (age 81 ± 7 years, 45% men) with symptomatic severe AS who were treated by TAVI. They underwent a clinical evaluation and a transthoracic echocardiography before the TAVI procedure and 6 months after., Results: In a multivariable analysis, the independent predictors for baseline PAP were the body mass index (BMI) ( β  = 0.21, p  = .006), COPD GOLD class ( β  = 0.20; p  = .009), the E / e ' ratio ( β  = 0.20; p  = .02) and the degree of aortic regurgitation ( β  = 0.20; p  = .01). After TAVI, there was significantly less (51% vs. 29%, p <.0001) pulmonary hypertension, defined as a tricuspid regurgitation velocity ≥2.8 m/s. The baseline variables related to an improvement in PAP were the tricuspid regurgitation velocity ( p  = .0001) and the E / e ' ( p  = .005). From the parameters potentially modified with TAVI, the only independent predictor of PAP variation was the change in the E / e ' ratio ( β  = 0.23; p  = .01)., Conclusions: Independent predictors for baseline PAP in elderly patients with symptomatic AS were the BMI, GOLD class, the aortic regurgitation and the E / e ' ratio. The baseline predictors for a change in PAP 6 months after TAVI were the baseline PAP and E / e ', with only the change in the E / e ' ratio being correlated to the change in PAP.

Objectives: The aim of this study was to assess the added value and predictive power of the TAVIguide (Added Value of Patient-Specific Computer Simulation in Transcatheter Aortic Valve Implantation) software in clinical practice., Background: Optimal outcome after transcatheter aortic valve replacement (TAVR) may become more important as TAVR shifts toward low-risk patients. Patient-specific computer simulation is able to provide prediction of outcome after TAVR. Its clinical role and validation of accuracy, however, have not yet been studied prospectively., Methods: A prospective, observational, multicenter study was conducted among 80 patients with severe aortic stenosis treated with the Evolut R valve. Simulation was performed in 42 patients and no simulation in 38. A comparison between the valve size (decision 1) and target depth of implantation selected by the operator on the basis of multislice computed tomography and the valve size (decision 2) and target depth of implantation selected after simulation were the primary endpoints. Predictive power was examined by comparing the simulated and observed degree of aortic regurgitation., Results: Decision 2 differed from decision 1 in 1 of 42 patients because of predicted paravalvular leakage, and changes in valve type occurred in 2 of 42. In 39 of 42 patients, decisions 1 and 2 were similar. Target depth of implantation differed in 7 of 42 patients after simulation (lower in 4 and higher in 3). In 16 of 42 patients, simulation affected the TAVR procedure; in 9, the operator avoided additional measures to achieve the target depth of implantation, and in 7 patients, additional measures were performed. There was a trend toward a higher degree of predicted than observed aortic regurgitation (17.5 vs. 12 ml/s; p = 0.13)., Conclusions: Patient-specific computer simulation did not affect valve size selection but did affect the selection of the target depth of implantation and the execution of TAVR to achieve the desired target depth of implantation., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: The indication for transcatheter aortic valve implantation (TAVI) has evolved from inoperable patients to patients at increased surgical risk. In low-risk patients, surgical aortic valve replacement (SAVR) remains the standard of care. The aim of this study was to explore the outcomes of TAVI and SAVR in patients with a Society of Thoracic Surgeons (STS) predicted risk of mortality (PROM) score below 3% in the SURTAVI trial., Methods and Results: In SURTAVI, patients at intermediate surgical risk based on Heart Team consensus were randomised to TAVI or SAVR. We stratified the overall patient population into quintiles based on the STS PROM score; the one-year mortality was correlated with the mean STS PROM score in each quintile. The quintiles were regrouped into three clinically relevant categories of STS score: less than 3%, 3 to <5%, and >5%. All-cause mortality or disabling stroke in each risk stratum was compared between TAVI and SAVR. Linear regressions between mean values of STS PROM in each quintile and observed all-cause mortality at one year showed great association for the global population (r2=0.92), TAVI (r2=0.89) and SAVR cohorts (r2=0.73). All-cause mortality or disabling stroke of TAVI vs. SAVR was 1.5% vs. 6.5% (p=0.04), 6.5% vs. 7.6% (p=0.52) and 13.5% vs. 11.0% (p=0.40) in the <3%, 3-5%, and ≥5% STS score strata, respectively., Conclusions: Among patients at intermediate surgical risk but with an STS PROM <3%, TAVI may achieve superior clinical outcomes compared to SAVR. These findings support the need for an adequately powered randomised trial to compare TAVI with SAVR in patients at low operative risk.

Aims: This analysis aimed to evaluate the incidence and predictors of the need for permanent pacemaker (PPM) implantation following implantation of the repositionable and fully retrievable LOTUS Aortic Valve Replacement System., Methods and Results: The prospective, single-arm, multicentre REPRISE II study with extended cohort enrolled 250 symptomatic, high surgical risk patients with severe aortic stenosis for transfemoral transcatheter aortic valve implantation (TAVI) with a 23 mm or 27 mm LOTUS valve. Echocardiography, computed tomography, and electrocardiography data were evaluated by independent core labs. Post TAVI, 32.0% (72/225) of pacemaker-naïve patients underwent new PPM implantation at 30 days. Most (59/72, 82%) patients were implanted for third-degree atrioventricular block, and >10% overstretch of the LVOT by area was observed in 59.7% (43/72) of PPM patients. Significant independent predictors of PPM at 30 days included baseline RBBB (odds ratio [OR] 12.7, 95% CI: 4.5, 36.2; p<0.001) and LVOT overstretch >10% (OR 3.4, 95% CI: 1.7, 6.7; p<0.001). There was a trend towards a lower 30-day PPM rate in patients with a shallower (≤5 mm) implant depth (23.9% ≤5 mm vs. 36.9% >5 mm depth from LCS; p=0.06)., Conclusions: Careful attention to valve sizing and implant depth may help to reduce the rate of PPM with the LOTUS valve.

Backgkground: The aim of this paper was to explore the determinants of aortic regurgitation (AR) after transcatheter aortic valve implantation (TAVI) using multi-slice computed tomography (MSCT) instead of echocardiography-guided sizing., Methods: Determinants of AR were assessed in 313 consecutive patients who underwent TAVI with the Medtronic (MCS, N.=259) or Edwards Sapien or XT (ESV, N.=54) using MSCT-guided sizing. AR was assessed by angiography immediately after TAVI (N.=313, Sellers) and by echocardiography at discharge (N.=285, VARC-2). Distinction was made between patients with grade 0-1 and grade ≥2 AR post-TAVI., Results: AR≥2 post-TAVI was seen in 91 patients or 29% (MCS 85/259: 33% vs. ESV 6/54:11%) by angiography and 94 patients or 33% (MCS 87/239:36% vs. ESV 7/46:15%) by echocardiography. By univariable analysis, patients with AR≥2 post TAVI had more AR≥2 at baseline (70% vs. 52%, P=0.003), a larger mean and maximal annulus diameter (25.0 [23.5-26.3] vs. 24.0 [22.6-26.0], P=0.025 and 27.9±2.7 mm vs. 27.0±2.8 mm, P=0.018, respectively) and a higher Agatston Score (3.9 [2.9-5.3] vs. 2.6 [1.8-3.8], P≤0.001). AR≥2 post-TAVI was more frequent after MCS than ESV (33% vs. 11%, P=0.001). There was no difference in nominal valve size relative to the patient's annulus, nor depth of implantation. By propensity score adjusted multivariable analysis, AR≥2 at baseline (odds 2.407 [95% CI: 1.472-3.938]) but above all MCS (odds: 6.047 [95% CI; 1.307- 27.976]) were independent determinants of AR≥2 post-TAVI. The latter was also confirmed by propensity score adjusted multivariable analysis in the echocardiography population (N.=285) (odds: 5.259 [95% CI; 1.070-25.851])., Conclusions: AR≥2 is more prevalent after MCS valve implantation and is an independent determinant of AR also when using MSCT guided-sizing.

Best practices for transcatheter aortic valve implantation with CoreValve include patient screening and valve size selection using multislice computed tomography, adherence to manufacturer recommendations for oversizing, control of implant depth to 6 mm or less, and management of conduction disturbances according to international guidelines. The ADVANCE II study implemented these strategies and demonstrated their relation to clinical outcomes. From October 2011 to April 2013, 200 patients with severe aortic stenosis were enrolled, and 194 were implanted. All imaging and electrocardiographic data were analyzed by an independent core laboratory, and adverse events were adjudicated to valve academic research consortium-2 definitions. The mean age was 80.2 ± 6.7 years and the mean Society of Thoracic Surgeons Predicted Risk of Mortality was 7.2 ± 6.8% for the enrolled patients. At 6 months, all-cause mortality was 9.2%, stroke was 2.6%, and permanent pacemaker implantation was 19.2% for class I and II indications. In patients with implant depth ≤6 mm, both mortality and permanent pacemaker implantation were lower than in patients with depth >6 mm (2.5% vs 14.5%, p <0.01 and 18.1% vs 31.7%, p = 0.03, respectively). The rate of moderate and severe paravalvular leak was 9.8% at 7 days after transcatheter aortic valve implantation, decreasing to 4.3% at 6 months (p = 0.02). Valves were significantly more oversized in patients with mild or less paravalvular leak at day 7 compared with those with moderate or severe (15.8 ± 8.0% vs 11.8 ± 4.9%, p = 0.01). In conclusion, findings from the ADVANCE II study reinforce that adherence to best clinical practices improves patient outcomes., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Aims: Our aim was to validate patient-specific software integrating baseline anatomy and biomechanical properties of both the aortic root and valve for the prediction of valve morphology and aortic leaflet calcium displacement after TAVI., Methods and Results: Finite element computer modelling was performed in 39 patients treated with a Medtronic CoreValve System (MCS; n=33) or an Edwards SAPIEN XT (ESV; n=6). Quantitative axial frame morphology at inflow (MCS, ESV) and nadir, coaptation and commissures (MCS) was compared between multislice computed tomography (MSCT) post TAVI and a computer model as well as displacement of the aortic leaflet calcifications, quantified by the distance between the coronary ostium and the closest calcium nodule. Bland-Altman analysis revealed a strong correlation between the observed (MSCT) and predicted frame dimensions, although small differences were detected for, e.g., Dmin at the inflow (mean±SD MSCT vs., Model: 21.6±2.4 mm vs. 22.0±2.4 mm; difference±SD: -0.4±1.3 mm, p<0.05) and Dmax (25.6±2.7 mm vs. 26.2±2.7 mm; difference±SD: -0.6±1.0 mm, p<0.01). The observed and predicted calcium displacements were highly correlated for the left and right coronary ostia (R2=0.67 and R2=0.71, respectively p<0.001)., Conclusions: Dedicated software allows accurate prediction of frame morphology and calcium displacement after valve implantation, which may help to improve outcome.

Aims: We evaluated a novel motion-compensating 3D reconstruction technique applied to rotational angiography (R-angio) which produces MSCT-like images for evaluation of implanted TAVI prostheses without requiring rapid pacing., Methods and Results: Fifty-one consecutive patients were retrospectively identified who were evaluated with rotational angiography (R-angio) using the Siemens Artis zee angiographic C-arm system after TAVI with a Medtronic CoreValve prosthesis. A novel 3D image reconstruction technique was applied which corrects for cardiac motion. CoreValve frame geometry was evaluated according to the same protocol for MSCT and R-angio at the level of: 1) the inflow, 2) the nadirs, 3) central coaptation, and 4) the commissures. The native aortic annulus dimensions were measured at the nadirs of the three leaflets. Sizing ratio, prosthesis expansion and frame ellipticity were assessed. Good quality 3D reconstructions were obtained in 43 patients (84%) and failure was predictable prior to reconstruction in six of the other seven patients (superposition of radiographically dense object n=4, obesity n=2). Prosthesis inflow ellipticity and expansion were correlated with implantation depth (respectively r=-0.46, p<0.01, and r=0.61, p<0.001). Aortic regurgitation grade ≥2 was associated with greater prosthesis ellipticity at the level of central coaptation (median [25th-75th percentile]: 1.15 [1.10-1.20] vs. 1.08 [1.06-1.12], p=0.009). The inter-observer, inter-modality (MSCT, R-angio) variability in measurement at the level of coaptation for minimum diameter, maximum diameter and area were all low (respectively, mean ±SD:1.2% ±1.2; 1.7% ±1.8 and 2.0% ±1.3)., Conclusions: R-angio with motion-compensated reconstruction offers new possibilities for evaluation of the post-implantation geometry of percutaneous structural heart prostheses and the potential clinical effects.

Background: Symptoms in the elderly patients with severe aortic stenosis (AS) and co-morbidities seem to lack in specificity. Therefore, objective parameters for increased left ventricular(LV) filling pressures are needed. The aim of this study was to investigate the correlation between the septal, lateral and average E/e' ratio and the value of the N-terminal pro-hormone of brain natriuretic peptide (NT-proBNP)., Methods: Two-hundred-fifty consecutive symptomatic patients (mean age 80 ± 8 years, 52% men) with severe AS underwent transthoracic echocardiography and NT-proBNP measurement., Results: In the overall population the septal E/e' (r = 0,459, r(2) = 0,21, P <0,0001), lateral E/e' (r = 0,322, r(2) = 0,10, P <0,0001), and the average E/e' (r = 0,432, r(2) = 0,18, P <0,0001) were all significantly correlated to NT-proBNP. After the exclusion of patients with confounders (more than mild aortic or mitral regurgitation, severe renal dysfunction, obesity or severe COPD) the septal E/e' (r = 0,584, r(2) = 0,34, P <0,0001), lateral E/e' (r = 0,377, r(2) = 0,14, P <0,0001), and the average E/e' (r = 0,487, r(2) = 0,24, P <0,0001) were all significantly better correlated to NT-proBNP. In obese patients no significant correlations were seen. Previous bypass surgery did not alter the correlations., Conclusions: In elderly patients with severe symptomatic AS there is a significant correlation between the E/e' ratio and NT-proBNP, in particular after exclusion of confounders. The correlation was best for the septal E/e' ratio and was preserved in patients with a history of bypass surgery.

Objectives: The aim of the CoreValve prospective, international, post-market ADVANCE-II study was to define the rates of conduction disturbances and permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement with the Medtronic CoreValve System (Minneapolis, Minnesota) using optimized implantation techniques and application of international guidelines on cardiac pacing., Background: Conduction disturbances are a frequent complication of transcatheter aortic valve replacement. The rates of PPI in the published reports vary according to bioprosthesis type and the indications for PPI., Methods: The primary endpoint was the 30-day incidence of PPI with Class I/II indications when the Medtronic CoreValve System was implanted at an optimal depth (≤6 mm below the aortic annulus). The timing and resolution of all new-onset conduction disturbances were analyzed., Results: A total of 194 patients were treated. The overall rate of PPI for Class I/II indications was 18.2%. An optimal depth was reached in 43.2% of patients, with a nonsignificantly lower incidence of PPI in patients with depths ≤6 mm, compared with those with deeper implants (13.3% vs. 21.1%; p = 0.14). In a paired analysis, new-onset left bundle branch block and first-degree atrioventricular block occurred in 45.4% and 39.0% of patients, respectively, and resolved spontaneously within 30 days in 43.2% and 73.9%, respectively. In patients with new PPI, the rate of intrinsic sinus rhythm increased from 25.9% at 7 days to 59.3% at 30 days (p = 0.004)., Conclusions: Optimal Medtronic CoreValve System deployment and adherence to international guidelines on cardiac pacing are associated with a lower rate of new PPI after transcatheter aortic valve replacement, compared with results reported in previous studies. (CoreValve Advance-II Study: Prospective International Post-Market Study [ADVANCE II]; NCT01624870)., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: Transcatheter aortic valve implantation (TAVI) is frequently complicated by new left bundle branch block (LBBB). We investigated the development and persistence of LBBB during follow-up and its clinical consequences., Methods and Results: ECGs at baseline, within 24 hours, before discharge and at 12 months after TAVI were assessed in 476 patients without pre-existing LBBB and/or pacemaker before or after TAVI. TAVI-induced new LBBB was categorised based on the timing of the occurrence (within 24 hours [acute], after 24 hours but before discharge [subacute], and after discharge [late]), in addition to persistence (transient or persistent). A total of 175 patients (36.8%) developed new LBBB of which 85.7% occurred within 24 hours after TAVI, 12.0% before and 2.3% after hospital discharge, and was persistent in 111 patients (63.4%). Implantation of the Medtronic CoreValve System (MCS) more frequently led to new LBBB than the balloon-expandable Edwards SAPIEN valve (ES) (53.8% versus 21.7%) with less recovery during follow-up (39.0% versus 9.5%). Late new LBBB was only seen in four patients (0.8%). During a median follow-up of 915 (578-1,234) days, persistent LBBB was associated with a significant increase in mortality as compared to no LBBB and temporary LBBB combined (hazard ratio 1.49, 95% confidence interval, 1.10-2.03; p=0.01)., Conclusions: TAVI-induced new LBBB occurs in almost 40% of patients, almost all before hospital discharge. It occurs three times more frequently after MCS than after ES valve implantation and has a twofold lower tendency to resolve during follow-up. Persistent LBBB is associated with a higher mortality.

Transcatheter aortic valve implantation (TAVI) implies the introduction, positioning, and deployment of a stented bioprosthesis in the (calcified) native aortic valve. We report an at first glance uneventful TAVI with the Medtronic Corevalve System, which was followed by transient electrocardiographic changes suggesting acute left main stem disease. The diagnosis of acute left main stem dissection extending from the left coronary cusp was firmly established by intravascular ultrasound. The ostium of the left main stem was successfully treated with intravascular ultrasound-guided placement of a drug eluting stent., (© 2013 Wiley Periodicals, Inc.)

Objectives: This study sought to compare all-cause mortality in patients at intermediate surgical risk undergoing transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR)., Background: Physicians are selecting "lower" surgical risk patients to undergo TAVI. No clinical data exist about the clinical outcomes of TAVI versus SAVR among intermediate-surgical-risk patients., Methods: We prospectively enrolled symptomatic patients with severe aortic stenosis who underwent TAVI or SAVR. Propensity-score matched pairs of TAVI and SAVR patients with Society of Thoracic Surgeons (STS) scores between 3% and 8% made up the study population. Primary endpoint was all-cause mortality at 1 year., Results: Between November 2006 and January 2010, 3,666 consecutive patients underwent either TAVI (n = 782) or SAVR (n = 2,884). Four hundred five TAVI patients were matched to 405 SAVR patients. Of matched TAVI patients, 99 (24%) patients had STS scores <3%, 255 (63%) had scores between 3% and 8%, and 51 (13%) had scores >8%. Among patients with STS scores between 3% and 8%, 20 (7.8%) versus 18 (7.1%) patients had died up to 30 days (hazard ratio: 1.12, 95% confidence interval: 0.58 to 2.15, p = 0.74) and 42 (16.5%) versus 43 (16.9%) patients had died up to 1 year (hazard ratio: 0.90, 95% confidence interval: 0.57 to 1.42, p = 0.64) after TAVI and SAVR, respectively. Effects of treatment on 1-year mortality were similar across all subgroups except for sex, with some evidence for a beneficial effect of TAVI in women but not in men (test for interaction p = 0.024)., Conclusions: Cumulative all-cause mortality at 30 days and 1 year was similar among propensity-score matched TAVI and SAVR patients at intermediate surgical risk. (Surgical Replacement and Transcatheter Aortic Valve Implantation [SURTAVI]; NCT01586910)., (Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Blood transfusion is associated with acute kidney injury (AKI) after transcatheter aortic valve implantation (TAVI). We sought to elucidate in more detail the relation between blood transfusion and AKI and its effects on short- and long-term mortality., Methods and Results: Nine hundred ninety-five patients with aortic stenosis underwent TAVI with the Medtronic CoreValve or the Edwards Valve in 7 centers. AKI was defined by the Valve Academic Research Consortium (absolute increase in serum creatinine ≥0.3 mg/dL [≥26.4 μmol/L] or ≥50% increase ≤72 hours). Logistic and Cox regression was used for predictor and survival analysis. AKI occurred in 20.7% (n=206). The number of units of blood transfusion ≤24 hours was the strongest predictor of AKI (≥5 units, OR, 4.81 [1.45-15.95], 3-4 units, OR, 3.05 [1.24-7.53], 1-2 units, OR, 1.47 [0.98-2.22]) followed by peripheral vascular disease (OR, 1.48 [1.05-2.10]), history of heart failure (OR, 1.43 [1.01-2.03]), leucocyte count ≤72 hours after TAVI (OR, 1.05 [1.02-1.09]) and European System for Cardiac Operative Risk Evaluation (EuroSCORE; OR, 1.02 [1.00-1.03]). Potential triggers of blood transfusion such as baseline anemia, bleeding-vascular complications, and perioperative blood loss were not identified as predictors. AKI and life-threatening bleeding were independent predictors of 30-day mortality (OR, 3.15 [1.56-6.38], OR, 6.65 [2.28-19.44], respectively), whereas transfusion (≥3 units), baseline anemia, and AKI predicted mortality beyond 30 days., Conclusions: AKI occurred in 21% of the patients after TAVI. The number of blood transfusions but not the indication of transfusion predicted AKI. AKI was a predictor of both short- and long-term mortality, whereas blood transfusion predicted long-term mortality. These findings indicate that outcome of TAVI may be improved by more restrictive use of blood transfusions.

Aims: We compared the measurement of aortic leaflet calcification on contrast and non-contrast MSCT and investigated predictors of the need for balloon post-dilatation after TAVI., Methods and Results: In 110 patients, who had TAVI with a Medtronic CoreValve prosthesis (MCS) for symptomatic aortic stenosis, calcification of the aortic root was measured on non-contrast MSCT (conventionally) and on contrast MSCT (signal attenuation >450 Houndsfield units). Calcium volume was underestimated on contrast- when compared to non-contrast MSCT: median (IQ-range)=759 (466 to 1295) vs. 2016 (1376 to 3262) and the difference between the two methods increased with higher calcium volumes (correlation coefficient r=0.90). Calcium mass was only slightly underestimated on contrast vs. non-contrast MSCT: median (IQ-range)=441 (268 to 809) vs. 555 (341 to 950) and there was no association between the differences and increasing calcium mass (r=0.17). Balloon post-dilatation was performed for significant aortic regurgitation after TAVI in 11 of 110 patients. When compared to controls, the patients who required balloon post-dilatation had higher aortic leaflet calcium on contrast CT (p<0.01), higher aortic annulus diameters (p<0.01) and higher annulus to prosthesis area ratio (p=0.01). ROC curves demonstrated that aortic root or aortic leaflet calcium measured on either contrast- or non-contrast MSCT showed excellent discrimination for the requirement of balloon post-dilatation (area under ROC >0.80 for all), whereas the discriminatory value of aortic annulus dimensions was moderate (area under ROC=0.69) and that of prosthesis to annulus ratio was poor (area under ROC=0.36)., Conclusions: Dense aortic leaflet calcification measured on contrast MSCT discerned well the need for balloon post-dilatation after TAVI with an MCS for significant PAR. Non-contrast MSCT may no longer be needed to quantify aortic root calcium before TAVI.

Background: To investigate the causes of paravalvular aortic regurgitation (PAR) after the implantation of the Medtronic CoreValve prosthesis (MCRS)., Methods and Results: Fifty-six patients underwent MSCT before TAVI with a MCRS and PAR was assessed with transthoracic echocardiography (TTE) between 5 and 10 days after TAVI. The aortic annulus smallest and largest orthogonal diameters and the mean diameter from the area were determined on MSCT on an axial image at the nadir of all three native leaflets. PAR was related to relevant anatomical structures on MSCT according to a clockface in the orientation of the parasternal short axis view on TTE. PAR ≥ 1 was present in 25% of the patients and was associated with a larger annulus, a lower degree of over sizing and with more aortic root calcification. On MSCT post TAVI malapposition was seen predominantly at the aorto-mitral fibrous continuity and the aspect of the largest diameter of the aortic annulus on the inside curve of the ascending aorta. PAR was predominantly seen at these two anatomic locations and less frequent in the area that contains the ventricular membranous septum and the area between the non- and right coronary sinus., Conclusions: Mild to moderate PAR is common after TAVI with the MCRS. The availability of additional (larger) prosthesis sizes in combination with improved sizing based on mean annulus diameter (e.g., D(CSA)) may help to reduce PAR., (Copyright © 2011 Wiley-Liss, Inc.)

A prosthesis-patient mismatch (PPM) is present when the prosthetic valve is too small in relation to the patient's body size. The purpose of the present study was to investigate the frequency of PPM after the implantation of the Medtronic CoreValve System, and its relation to the clinical outcome. The indexed effective orifice area (EOA) was measured in 74 patients with symptomatic severe aortic stenosis, who had undergone successful transcatheter aortic valve implantation with the Medtronic CoreValve System, at baseline and discharge. PPM was defined as severe (indexed EOA <0.65 cm(2)/m(2)) or moderate (indexed EOA 0.65 to 0.85 cm(2)/m(2)). The indexed EOA increased from 0.35 +/- 0.13 to 0.97 +/- 0.34 cm(2)/m(2) after transcatheter aortic valve implantation (p <0.001) and was accompanied by significant clinical improvement. Severe and moderate PPMs were found in 16% and 23% of patients, respectively. Patients with severe PPM were more symptomatic and had a smaller indexed EOA at baseline than those with moderate or no PPM (0.28 +/- 0.09 vs 0.36 +/- 0.12 cm(2)/m(2), p <0.05). Functional status and mortality at 30 days and 6 months was not significantly different between the patients with severe PPM and those with moderate or no PPM. In conclusion, the indexed EOA increased significantly after transcatheter aortic valve implantation. Severe PPM was observed in 16% of the patients and was not associated with the clinical outcome., (Copyright (c) 2010 Elsevier Inc. All rights reserved.)