Quality of Life Measures in Aortic Stenosis Research: A Narrative Review.

BACKGROUND: Elderly patients with aortic stenosis (AS) not only have a reduced life expectancy but also a reduced quality of life (QoL). The benefits of an AS intervention may be considered a balance between a good QoL and a reasonably extended life. However, the different questionnaires being used to determine the QoL were generally not developed for the specific situation of patients with AS and come with strengths and considerable weaknesses. The objective of this article was to provide an overview of the available QoL instruments in AS research, describe their strengths and weaknesses, and provide our assessment of the utility of the available scoring instruments for QoL measurements in AS. SUMMARY: We identified and reviewed the following instruments that are used in AS research: Short Form Health Survey (SF-36/SF-12), EuroQol-5D (EQ-5D), the Illness Intrusiveness Rating Scale (IIRS), the HeartQoL, the Kansas City Cardiomyopathy Questionnaire (KCCQ), the Minnesota Living with Heart Failure Questionnaire (MLHF), the MacNew Questionnaire, and the Toronto Aortic Stenosis Quality of Life Questionnaire (TASQ). KEY MESSAGES: There is no standardized assessment of QoL in patients with AS. Many different questionnaires are being used, but they are rarely specific for AS. There is a need for AS-specific research into the QoL of patients as life prolongation may compete for an improved QoL in this elderly patient group.

Midterm outcomes of transaortic and transapical TAVI in patients with unsuitable vascular anatomy for femoral access: A propensity score inverse probability weight study.

AIMS: Transaortic (TAo) and transapical (TA) implantation can be used in transcatheter aortic valve implantation (TAVI) when the transfemoral (TF) approach is precluded. We compare the safety and efficacy of these alternative techniques. METHODS: From October 2007 to February 2016, TAo and TA patients' data were collected. Propensity score inverse probability of treatment weight (IPTW) method was employed to minimize the impact of no-randomization bias. RESULTS: From our single-center non-TF-TAVI registry, 282 patients were included: 235 (83.3%) underwent TAo and 47 (16.7%) TA. Differences in baseline characteristics were statistically significant in age, sex, risk profile according to logistic-EuroSCORE, and previous cardiac surgery. No difference in hospital morbidity and mortality, but lower stroke-rate in TAo (1.27% vs. 8.5% p < .01) was observed. This was confirmed at logistic regression after IPTW adjustment (odds ratio [OR]: 0.16, 95% CI 0.03-0.71, p = .01), together with reduced risk of the paravalvular leak (PVL) (OR: 0.14, 95% confidence interval [CI]: 0.02-0.81, p = .02). Kaplan-Meier estimates did not demonstrate differences in long-term mortality among access routes (logrank test p = .13). At the IPTW-Cox regression model, long-term mortality was related to New York Heart Association III-IV (hazard ratio [HR]: 2.92, 95% CI: 1.15-7.40, p = .026), chronic renal failure (HR: 3.25; 95% CI: 1.02-10.32 p = .046), previous transient ischemic attack/stroke (HR: 2.29, 95% CI: 1.25-4.20 p = .007). Sapien-3 device resulted to be a protective factor, reducing long-term mortality (HR: 0.18, 95% CI 0.04- 0.90 p = .03). CONCLUSIONS: TAo is safe and feasible in case of contraindication to femoral approach demonstrating comparable midterm outcomes to TA, thus representing a central access alternative, to increase the overall safety of high-risk TAVI procedures.

Balloon-expandable transcatheter aortic valve implantation with or without pre-dilation - results of a meta-analysis of 3 multicenter registries.

BACKGROUND: To evaluate the outcomes of transcatheter aortic valve implantation (TAVI) without balloon aortic valvuloplasty (BAV) in a real-world setting through a patient-level meta-analysis. METHODS: The meta-analysis included patients of three European multicenter, prospective, observational registry studies that compared outcomes after Edwards SAPIEN 3 or XT TAVI with (n = 339) or without (n = 355) BAV. Unadjusted and adjusted pooled odds ratios (with 95% confidence intervals) were calculated for procedural and 30-day outcomes. RESULTS: Median procedural time was shorter in the non-BAV group than in the BAV group (73 versus 93 min, p = 0.001), as was median fluoroscopy time (7 versus 11 min, p = 0.001). Post-delivery balloon dilation (15.5% versus 22.4%, p = 0.02) and catecholamine use (9.0% vs. 17.9%; p = 0.016) was required less often in the non-BAV group than in the BAV group with the difference becoming insignificant after multiple adjustment. There was a reduced risk for periprocedural atrioventricular block during the intervention (1.4% versus 4.1%, p = 0.035) which was non-significant after adjustment. The rate of moderate/severe paravalvular regurgitation post-TAVI was 0.6% in the no-BAV group versus 2.7% in the BAV group. There were no between-group differences in the risk of death, stroke or other adverse clinical outcomes at day 30. CONCLUSIONS: This patient-level meta-analysis of real-world data indicates that TAVI performed without BAV is advantageous as it has an adequate device success rate, reduced procedure time and no adverse effects on short-term clinical outcomes.

Incidence and predictors of coronary obstruction following transcatheter aortic valve implantation in the real world.

OBJECTIVES: Coronary obstruction (CO) is a rare but serious complication of transcatheter aortic valve implantation (TAVI). There are very limited data regarding CO following TAVI. The aim of this study was to evaluate the incidence and outcomes of CO after TAVI and identify the predictors including the valve type. METHODS: Between October 2006 and March 2015, 1,203 TAVI cases were performed in our institution. Of them, 814 cases whose coronary height was measured using computed tomography for screening were analyzed in this study. RESULTS: The Edwards SAPIEN/SAPIEN XT (S/XT) was used in 427 (52.4%) cases, the CoreValve in 265 (32.6%), and the S3 in 122 (15.0%). CO occurred in 8 (1.0%) cases, 1.6% with S/XT, 0.4% with CoreValve, and 0% with S3. All instances of CO occurred at the left coronary artery. The 30-day mortality was significantly higher in cases of CO (37.5% vs. 5.8%, P = 0.010). The frequency of CO tended to be lower in recipients of the CoreValve (0.4%) and S3 (0%) compared with the S/XT (1.6%) (P = 0.188 for CoreValve vs. S/XT, P = 0.022 for S3 vs. S/XT). CONCLUSIONS: CO has poor outcomes and identification of patients at risk of CO to take preventive measures is crucial. The preliminary data showing that the occurrence of CO is low in patients receiving the S3 despite increased prosthesis height need further confirmation. © 2017 Wiley Periodicals, Inc.

Is postdilatation useful after implantation of the Edwards valve?

BACKGROUND: Few data are available about postdilatation (PD) for the treatment of significant paravalvular aortic regurgitation (AR) after transcatheter aortic valve implantation of the Edwards valve. METHODS AND RESULTS: A total of 470 patients, aged 83.4 ± 6.4 yrs, with logistic European System for Cardiac Operative Risk Evaluation 21.9 ± 12.3, undergoing transcatheter aortic valve implantation with the Edwards valve were evaluated. PD was performed using the balloon delivery system when significant paravalvular AR was identified. The diameter of the valve was measured from cine acquisition at three different levels. PD was performed in 49 (10.4%) patients with grade 2, 3, or 4 AR as 42.1%, 55.3%, and 2.6%, respectively. After PD, a reduction of at least 1 degree of AR was achieved in 81.5% of cases. Residual AR grades 2, 3, and 4 were observed in 36.8%, 10.5%, and 0%, respectively. A significant increase in the prosthesis diameter was observed at the three valve levels (absolute Δ 3.5%-5.4%, P.< 0.01). For the 23 mm valve, mid level of valve increased from 23.0 ± 0.4 to 24.1 ± 0.5 mm (P < 0.01) and for the 26 mm, from 25.2 ± 0.9 to 26.6 ± 0.9 mm (P < 0.01). Occurrence of annulus rupture (4.1% vs. 1.7%, P = 0.24), cerebrovascular accidents (2.0% vs. 2.1%, P = 0.72), need for new pacemaker (8.2% vs. 5.5%, P = 0.31), and 30-day composite endpoint (24.5% vs. 20.2%, P = 0.48) were not significantly different between PD and non-PD groups. CONCLUSIONS: PD for the treatment of significant paravalvular leak proved to be a feasible treatment allowing a significant increase in valve size and decrease in PVL without increase in stroke rates. This promising approach needs further confirmation.

Prognostic value of aortic root calcification volume on clinical outcomes after transcatheter balloon-expandable aortic valve implantation.

BACKGROUND: Few data are available about whether aortic root calcification may impact the outcomes after transcatheter aortic valve implantation (TAVI). OBJECTIVES: This study sought to evaluate the impact of aortic root calcification volume on clinical outcome after TAVI with balloon expandable Edwards Sapien XT valve (Edwards Lifesciences, Irvine, California). METHODS: A total of 162 TAVI patients (aged 84.0 [Interquartile Range (IQR) 81.0-84.0] years, Logistic EuroSCORE 14.5 [IQR 9.8-25.1]) with preprocedural MDCT were studied. Aortic root calcification volume was measured by MDCT image and using the dedicated software for aortic valve assessment (the automated 3mensio™ Valves 5.1, sp1, 3mensio Pie Medical Imaging BV, Maastricht, the Netherlands). A valve calcification index (VCI) was defined as calcification volume (mm(3))/body surface area (mm(2)). RESULTS: VCI was significantly higher among patients with 30-day mortality. A VCI threshold of 517.4 (area under the curve 0.69, 95% CI 0.50-0.87, P = 0.03) predicted a higher incidence of annulus rupture (9.1 vs. 0.9%, P = 0.02) and cardiac tamponade (12.7 vs. 1.9%, P < 0.01), lower device success (83.6% vs. 95.3%, P < 0.01) and 30-day survival rate (80.0% vs. 97.2%, P < 0.01). Multivariate logistic regression analysis showed only ejection fraction and VCI were identified as independent predictors of 30-day mortality (Odds ratio 0.948 [95% confidence interval 0.909-0.988], P = 0.012, Odds ratio 1.003 [95% confidence interval 1.001-1.005], P = 0.013, respectively). CONCLUSIONS: Significantly worse acute clinical outcomes after Edwards valve implantation were observed in patients with large amount of aortic annulus calcifications quantitatively measured by dedicated MDCT software. Application of VCI may prove helpful in prediction of clinical outcomes after TAVI.

Can we predict postprocedural paravalvular leak after Edwards SAPIEN transcatheter aortic valve implantation?

BACKGROUND: Postprocedural paravalvular leak (PVL) ≥ 2 has been shown to be associated with worse outcomes after transcatheter aortic valve implantation (TAVI). This study sought to identify predictive factors of postprocedural PVL ≥ 2 after TAVI with the Edwards valve. METHODS AND RESULTS: A total of 176 patients with Edwards TAVI (aged 83.4 ± 7.4 years, Logistic EuroSCORE [the Logistic European System for Cardiac Operative Risk Evaluation] 18.8 ± 12.0, transfemoral 54.5%) who had preprocedural multidetector computed tomography (MDCT) were studied. A PVL ≥ 2 was observed in 12.5% of cases. By multivariate analysis, only the valve calcification index (VCI) defined as aortic root calcification volume/body surface area (odds ratio [OR] = 1.002, 95% confidence interval [CI] = 1.001-1.004, P = 0.006) and the valve diameter/the calculated average annulus diameter (CAAD) by MDCT (OR = 0.683, 95% CI = 0.474-0.984, P = 0.041) were identified as independent predictors of postprocedural PVL ≥ 2. A score predicting postprocedural PVL ≥ 2 (PVL score) was determined by allotting one point when the valve diameter/CAAD ratio was <1.055 and one point when VCI was >418.4 mm(3) /m(2) , and summing all points accrued. Area under receiver-operator characteristic curves of PVL score was 0.71 (95% CI = 0.59-0.83, P < 0.01). The incidence of PVL ≥ 2 was 5.3% in patients with a PVL score of 0, 11.8% for a PVL score of 1 and 37.5% for a PVL score of 2. CONCLUSIONS: The only predictors of PVL ≥ 2 after Edwards valve implantation are the valve diameter/CAAD and VCI. The PVL score could prove to be an excellent tool for predicting the risk of PVL.

Usefulness of a Simple Clinical Risk Prediction Method, Modified ACEF Score, for Transcatheter Aortic Valve Implantation.

BACKGROUND: We assessed the predictive accuracy of a simple risk score, modified age, creatinine clearance, ejection fraction (ACEFmodif) score, for outcome of transcatheter aortic valve implantation (TAVI). METHODS AND RESULTS: We prospectively included 703 consecutive patients undergoing TAVI. Patients were divided into low, middle and high ACEFmodif tertiles. Increased ACEFmodif score was associated with a significantly higher 1-year mortality rate (22%, 28% and 36%, P<0.01) and higher risk of acute kidney injury (AKI; 10%, 10% and 22%, P<0.01). On multivariate logistic regression analysis, ACEFmodif score was the only independent predictor of AKI. On multivariate Cox regression, ACEFmodif score was an independent predictor of 1-year cumulative mortality. Although the area under curve (AUC) showed that all risk scores poorly predicted the incidence of AKI and 1-year cumulative mortality, ACEFmodif score was more efficient in predicting the incidence of AKI compared with STS, LES and ES II (AUC, 0.61, 0.55, 0.54, 0.57, respectively). Furthermore, ACEFmodif score had similar accuracy in predicting 1-year mortality compared with other risk scores (AUC, 0.61, 0.61, 0.61, 0.61, respectively). CONCLUSIONS: ACEFmodif score may provide useful information for predicting AKI, 30-day and 1-year mortality in patients undergoing TAVI, but these results need further confirmation.

TAVI and Bicuspid Aortic Valve: Check the Inter-Commissural Space!

Transcatheter aortic valve implantation (TAVI) in cases of bicuspid aortic valve (BAV) with a large aortic annulus remains challenging and is rarely performed due to the risk of residual paravalvular aortic leakage. A SAPIEN 3 prosthesis was successfully implanted in two BAV patients each with a relatively large aortic annulus. The New SAPIEN 3 design, coupled with good sealing at the level of the inter-commissural space of the bicuspid valve, seems to account for the efficiency of TAVI for BAV with a large annulus.

Transcatheter aortic valve implantation in patients of small body size.

AIMS: The aim of this study was to evaluate the efficacy and safety of transcatheter aortic valve implantation (TAVI) in patients of small body size (SB). METHODS AND RESULTS: Between October 2006 and November 2011, 424 patients undergoing TAVI were evaluated. Patients with a small body surface area (BSA; <1.75 m(2)) were defined as the "SB group" (n = 215) and the remaining large BSA patients as the "LB group" (n = 209). In the SB group, mean annulus diameter measured by CT and minimal femoral artery diameter were significantly smaller (23.1 ± 1.92 vs. 24.3 ± 1.91 mm, P < 0.01; 7.59 ± 1.06 vs. 8.29 ± 1.34 mm, P < 0.01, respectively). The logistic EuroSCORE was similar between groups (22.5 ± 10.4 vs. 23.4 ± 12.0; P = 0.43). Equivalent device success (91.2% vs. 91.4%; P = 0.94) and 30-day survival rates (85.1% vs. 87.6%; P = 0.46) were achieved in both groups. Vascular complications and the 30-day combined safety end point rate were significantly higher in the SB group (13.0% vs. 4.3%, P < 0.01; 27.4% vs. 18.3%, P = 0.03, respectively). Similar post-procedural mean pressure gradient was achieved in both groups (10.2 ± 4.3 vs. 11.0 ± 4.6 mmHg; P = 0.12). Multivariate analysis showed that BSA was one of the independent predictors of 30-day combined safety end point (Odds ratio: 0.20; 95% confidence interval (CI): 0.05-0.88; P = 0.03). However, Kaplan-Meier analysis revealed no significant difference in mid-term survival rate between groups (log-rank P = 0.64). CONCLUSIONS: TAVI in SB patients resulted in similar clinical outcomes with effective post-procedural hemodynamics compared with LB patients. Care should be taken to avoid vascular complications in SB patients.

Transaortic transcatheter aortic valve implantation - rationale and design of the multicenter, multinational prospective ROUTE registry.

BACKGROUND: Transaortic transcatheter aortic valve implantation (TAo-TAVI) is a recently developed approach that provides an alternative delivery route for valve replacement in patients with vascular abnormalities or existing comorbidities. While initial studies have shown the principal efficacy and safety, the real world effectiveness and safety of this approach remains to be fully assessed. METHODS/DESIGN: In this regard, the Registry Of the Utilization of the TAo-TAVI approach using the Edwards SAPIEN Valve (ROUTE) represents the first multicenter, multinational prospective documentation of the course and outcome of patients with severe calcific aortic stenosis (AS) undergoing TAo-TAVI. ROUTE commenced in February 2013 with the goal of consecutively enrolling 300 patients at up to 22 sites across Europe. The primary objective of ROUTE is to determine the 30-day mortality associated with TAo-TAVI using the Edwards SAPIEN THV (Edwards Lifesciences, Irvine, CA). In addition, ROUTE aims to quantify complications, predictors of patient outcome and the value of CT guided valve sizing. DISCUSSION: Findings from this landmark registry will provide important information regarding procedural success rates and early mortality in patients undergoing TAo-TAVI. TRIAL REGISTRATION: Identifier: NCT01991431.

Potential mechanism of annulus rupture during transcatheter aortic valve implantation.

Although annulus rupture is one of the most severe complications of transcatheter aortic valve implantation (TAVI), the incidence and mechanism of this complication remain unclear. Out of 387 consecutive TAVI cases in our institution, the incidence of annulus rupture was 1.0% (4/387). The first two patients died because of hemodynamic collapse due to tamponade on day 0. Both surviving patients had undergone preprocedural multidetector computed tomography which revealed large calcifications in the epicardial fat part of the aortic annulus. In both cases, annulus rupture occurred after deployment of a balloon expandable valve suggesting that mechanical compression of this "vulnerable area" by calcification may cause annulus rupture.

Is EuroSCORE II better than EuroSCORE in predicting mortality after transcatheter aortic valve implantation?

OBJECTIVES: The purpose of this study was to examine the performance of the European system for cardiac operative risk evaluation II (ESII) in patients undergoing transcatheter aortic valve implantation (TAVI). BACKGROUND: The ESII was developed recently to improve the predictive value of the original logistic EuroSCORE (LES). METHODS: Between October 2006 and November 2011, 453 consecutive patients with severe aortic stenosis undergoing TAVI with either the Edwards valve or the Corevalve were included in the current analysis. The performance of the ESII, LES, and society of thoracic surgeons predicted risk of mortality score (STS) was evaluated. RESULTS: Mean age was 83.1 ± 6.4 years. The Edwards valve was used in 382 patients (84.3%) of the cohort, transfemoral approach (TF) in 55.0%, transapical approach (TA) in 25.2%, transaortic approach (TAo) 17.8%, transsubclabian approach (SC) 2.0%. The observed 30-day mortality was 12.6% (11.2, 18.4, 7.4, and 22.2% for TF, TA, TAo, SC, respectively). The mean LES, STS, and ESII were 22.4 ± 12.1, 8.1 ± 6.0, and 8.1 ± 5.2, respectively. The Hosmer-Lemeshow test showed ESII was inadequately calibrated for 30-day mortality compared with other risk scores (ESII P = 0.09, LES P = 0.84, STS P = 0.34). By using the area under the receiver operating characteristic curve (AUC), ESII better predicted 30-day mortality, albeit poorly, compared to LES and STS (AUC = 0.68, 0.65, and 0.60, respectively). In the TF cohort, ESII was better in predicting 30-day mortality compared to LES and STS (AUC = 0.74, 0.61, 0.60, respectively). CONCLUSIONS: Although the ESII demonstrated better predictive performance especially in the TF cohort, ESII is still inadequate in predicting mortality after TAVI as are LES and STS.

One year follow-up of the multi-centre European PARTNER transcatheter heart valve study.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) has emerged as a new therapeutic option in high-risk patients with severe aortic stenosis. AIMS: PARTNER EU is the first study to evaluate prospectively the procedural and mid-term outcomes of transfemoral (TF) or transapical (TA) implantation of the Edwards SAPIEN® valve involving a multi-disciplinary approach. METHODS AND RESULTS: Primary safety endpoints were 30 days and 6 months mortality. Primary efficacy endpoints were haemodynamic and functional improvement at 12 months. One hundred and thirty patients (61 TF, 69 TA), aged 82.1 ± 5.5 years were included. TA patients had higher logistic EuroSCORE (33.8 vs. 25.7%, P = 0.0005) and more peripheral disease (49.3 vs. 16.4%, P< 0.0001). Procedures were aborted in four TA (5.8%) and six TF cases (9.8%). Valve implantation was successful in the remaining patients in 95.4 and 96.4%, respectively. Thirty days and 6 months survival were 81.2 and 58.0% (TA) and 91.8 and 90.2% (TF). In both groups, mean aortic gradient decreased from 46.9 ± 18.1 to 10.9 ± 5.4 mmHg 6 months post-TAVI. In total, 78.1 and 84.8% of patients experienced significant improvement in New York Heart Association (NYHA) class, whereas 73.9 and 72.7% had improved Kansas City Cardiomyopathy Questionnaire (KCCQ) scores in TA and TF cohorts, respectively. CONCLUSION: This first team-based multi-centre European TAVI registry shows promising results in high-risk patients treated by TF or TA delivery. Survival rates differ significantly between TF and TA groups and probably reflect the higher risk profile of the TA cohort. Optimal patient screening, approach selection, and device refinement may improve outcomes.

Quality of life after transcatheter or surgical aortic valve replacement using the Toronto Aortic Stenosis Quality of Life Questionnaire.

BACKGROUND: The Toronto Aortic Stenosis Quality of Life Questionnaire (TASQ) is a validated instrument for assessing quality of life (QoL) in patients with severe aortic stenosis (AS). In this study, we evaluated health status outcomes, based on the TASQ, in patients with severe AS undergoing transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). METHODS: The TASQ registry was a prospective observational registry. Patients with severe AS from nine centres in Europe and one in Canada underwent either SAVR or transfemoral TAVR. Patients completed the TASQ, Kansas City Cardiomyopathy Questionnaire and Short Form-12 V.2 prior to the intervention, predischarge, and at 30-day and 3-month follow-ups. Primary end point was the TASQ score. RESULTS: In both the TAVR (n=137) and SAVR (n=137) cohorts, significant increases were observed in all three scores. The overall TASQ score improved as did all but one of the individual domains at 3 months after the intervention (p<0.001). TASQ health expectations were the only domain which worsened (p<0.001). Across TASQ subscores, significant changes were evident from the time of discharge in the TAVR and 30-day follow-up in the SAVR cohort. In a categorical analysis of the TASQ, 39.7% of the TAVR group and 35.0% of the SAVR group had a substantially improved health status at 3 months compared with baseline. CONCLUSIONS: The TASQ captured changes in QoL among patients with severe AS who were treated with TAVR or SAVR. QoL improved substantially after either intervention, as indicated by changes in the TASQ overall score at 3 months. TRIAL REGISTRATION NUMBER: NCT03186339.

Aortic valve replacement: validation of the Toronto Aortic Stenosis Quality of Life Questionnaire.

AIMS: There is no quality of life tool specifically developed for patients with severe aortic stenosis (AS) to assess how this chronic condition and its treatment affect patients. The Toronto Aortic Stenosis Quality of Life Questionnaire (TASQ) has been developed to overcome this gap. The results of the validation of the TASQ in patients undergoing treatment for severe AS are presented. METHODS AND RESULTS: Prospective study at 10 centres in Europe and Canada, which enrolled 274 patients with severe symptomatic AS undergoing surgical or transcatheter aortic valve replacement. Mean TASQ score at baseline was 71.2 points and increased to 88.9 three months after aortic valve implantation (P < 0.001). Increases were seen for the emotional impact (32.0 to 39.0; P < 0.001), physical limitations (14.8 to 22.0; P < 0.001), and physical symptoms (8.5 vs. 11.0; P < 0.001) domains. Internal consistency was good/excellent for overall TASQ score (α = 0.891) and for the physical limitation, emotional impact, and social limitation domains (α = 0.815-0.950). Test-retest reliability was excellent or strong for the overall TASQ (intraclass correlation coefficient of 0.883) and for the physical symptoms, physical limitation, emotional impact, and social limitation domains (intraclass correlation coefficient of 0.791-0.895). Responsiveness was medium overall (Cohen's d = 0.637) and medium/large for physical symptoms, emotional impact, and physical limitations (0.661-0.812). Sensitivity to change was significant for physical symptoms, physical limitations (both P < 0.001), emotional impact (P = 0.003), and social limitations (P = 0.038). CONCLUSIONS: The TASQ is a new, brief, self-administered, and clinically relevant health-specific tool to measure changes in quality of life in patients with AS undergoing an intervention.

Safety and effectiveness of a transaortic approach for TAVI: procedural and midterm outcomes of 265 consecutive patients in a single centre.

OBJECTIVES: Transcatheter aortic valve implantation with a transaortic approach (TAo-TAVI) is an alternative to transapical or femoral access. We studied the procedural and midterm efficacy and safety of TAo-TAVI with Edwards Sapien XT and Medtronic CoreValve devices. METHODS: Among 901 patients receiving TAVI since 2006, 265 consecutive patients underwent TAo-TAVI between January 2011 and September 2014. Procedural and midterm results were evaluated according to Valve Academic Research Consortium-2 criteria. RESULTS: The mean age was 83 ± 5 years. Sapien XT and CoreValve were used in 191 (72.1%) and 74 (27.9%) patients, respectively. Full sternotomy made elective concomitant off-pump coronary artery bypass grafting possible in 38 patients (14.3%) with severe coronary artery disease unsuitable for percutaneous coronary intervention. The device success rate was 95.5%. Postprocedural paravalvular leak ≥2/4 was observed in 16 patients (6.4%). Emergency open chest surgery was required in 10 patients (3.8%) (3 aortic dissections, 3 valve embolizations, 2 LMCA occlusions, 1 aortic annulus rupture and 1 aortic rupture). Cerebrovascular accidents occurred in 3 patients (1.1%). Transfusions ≥4 units were required in 36 patients (13.6%). New pacemakers were implanted in 26 patients (9.8%). Thirty-day and 1-year mortality were 8.7% and 16.2%, respectively. Mean follow-up duration was 24 ± 6 months. At 3 years, freedom from all-cause death was 80% ± 4%. New York Heart Association class

Outcomes after transaortic transcatheter aortic valve implantation: long-term findings from the European ROUTE†.

OBJECTIVES: There is lack of data regarding the longer-term outcomes of patients undergoing transaortic (TAo) transcatheter aortic valve implantation (TAVI). We aimed to provide a contemporary snapshot of the types and frequencies of events in the year following TAo-TAVI. METHODS: The Registry of the Utilization of the TAo-TAVI approach using the Edwards SAPIEN Valve (ROUTE) is a multicentre, European, prospective, observational registry of aortic stenosis patients undergoing TAo-TAVI. Patients were grouped according to the composite end point death, myocardial infarction, stroke/transient ischaemic attack, major vascular complications, life-threatening bleeding, acute kidney injury (AKI) and/or cardiovascular rehospitalization. RESULTS: Two hundred and fifty-three patients with a mean age of 81.5 ± 5.8 years were included, of whom 89 (35.2%) patients met the composite end point (the event group) and 164 (64.8%) patients did not (the event-free group). New York Heart Association (NYHA) class III/IV (85.2% vs 71.8%, P = 0.017), Canadian Cardiovascular Society angina class III/IV (22.6% vs 11.4%; P = 0.021), pulmonary disease (32.6% vs 18.9%; P = 0.015) and renal insufficiency (15.7% vs 3.0%; P < 0.001) were more common in the event group. At 1 year, the most common event was death (19.1%), followed by AKI stage II or III (14.7%). The baseline renal insufficiency was the strongest independent predictor of composite end point achievement [odds ratio (OR) 7.55, 95% confidence interval (CI) 2.33-24.56], followed by NYHA class III/IV (OR 2.316, 95% CI 1.06-5.06) and pulmonary disease (OR 2.91, 95% CI 1.45-5.85). Pulmonary disease was also an independent predictor of 1-year mortality (OR 3.01, 95% CI 1.34-6.75). CONCLUSIONS: Long-term outcomes after TAo-TAVI appear to be similar to those for TAVI via other non-transfemoral access routes. Awareness of characteristics associated with poorer outcomes may aid patient selection and identification of those requiring closer post-procedural monitoring. CLINICAL TRIAL REGISTRATION NUMBER: ClinicalTrials.gov identifier: NCT01991431.

Trial protocol for the validation of the 'Toronto Aortic Stenosis Quality of Life (TASQ) Questionnaire' in patients undergoing surgical aortic valve replacement (SAVR) or transfemoral (TF) transcatheter aortic valve implantation (TAVI): the TASQ registry.

Background: Patients with severe aortic stenosis (AS) have a reduced life expectancy and quality of life (QoL), owing to advanced age and the presence of multiple comorbidities. Currently, there is no AS-specific QoL measurement tool, which prevents an accurate assessment of how this chronic condition and its treatment affect patients. The Toronto Aortic Stenosis Quality of Life Questionnaire (TASQ) was developed in order to address this deficiency. Methods: The present trial protocol was designed to enable validation of the TASQ, which has been produced in five languages (English, French, German, Italian and Spanish) to increase usability. Patients with severe AS who are undergoing surgical aortic valve replacement (SAVR) or transcatheter aortic valve implantation (TAVI) will be asked to complete the TASQ and, for comparative purposes, the Kansas City Cardiomyopathy Questionnaire and the general health-related QoL Short Form-12 questionnaire. The questionnaires will be completed prior to the intervention, at discharge, as well as at 30 days and 3 months follow-up. A total of 290 patients will be recruited across one Canadian and nine European centres. Overall, the protocol validation aims to include 120 patients undergoing transfemoral TAVI (TF-TAVI), 120 undergoing SAVR and up to 50 being treated medically. The primary objective of the registry is to validate the TASQ in five different languages. The secondary objective is to assess the utility of the TASQ for assessing differences in QoL outcome between patients undergoing TF-TAVI, SAVR or medical management for their AS. Discussion: Validation and roll-out of the TASQ will enable clinicians to capture an accurate assessment of how AS and its management affects the QoL of patients and will help them to determine the most appropriate treatment strategy for individual patients. Trial registration number: NCT03186339.

Transcatheter Aortic Valve Replacement in the Catheterization Laboratory Versus Hybrid Operating Room: Insights From the FRANCE TAVI Registry.

OBJECTIVES: This study sought to compare outcomes of patients undergoing transcatheter aortic valve replacement (TAVR) in a catheterization laboratory (cath lab) to those undergoing TAVR in a hybrid operating room (OR). BACKGROUND: TAVR can be performed in a cath lab or in a hybrid OR. Comparisons between these locations are scarce. METHODS: All TAVRs performed in 48 centers across France between January 2013 and December 2015 were prospectively included in the FRANCE TAVI (French Transcatheter Aortic Valve Implantation) registry. The primary endpoint of this study was all-cause mortality at 1 year. Secondary endpoints consisted of 30-day complications and 3-year mortality. All analyses were adjusted for baseline and procedural characteristics. RESULTS: A total of 12,121 patients were included in this study, 62% of which underwent TAVR in a cath lab versus 38% in a hybrid OR. Mean age was 82.9 ± 7.2 years, 48.9% of patients were men, and mean Logistic EuroScore was 17.9% ± 12.3%. Both procedure locations showed similar, below 2% rates of intraprocedural complications. After adjusting for baseline and procedural characteristics, major bleeding and infections were significantly higher in the hybrid OR group (bleeding, 6.3% vs. 4.8%; infection, 6.1% vs. 3.5%; p < 0.05). Adjusted mortality rates at 1 and 3 years did not differ significantly between groups (for cath lab vs. hybrid OR, respectively: 1 year: 16.2% vs. 15.8%; p = 0.91; 3 years: 38.4% vs. 36.4%; p = 0.49). CONCLUSIONS: Midterm mortality after TAVR was similar between the cath lab and the hybrid OR. These findings support the performance of TAVR in either location, which has important implications on health care organization and costs.