Transapical Transcatheter Aortic Valve Implantation Research Articles

RETRACTED: Thoracoabdominal nerves block through perichondral approach for transapical transcatheter aortic valve implantation

This article has been retracted: please see Elsevier Policy on Article Withdrawal (http://www.elsevier.com/locate/withdrawalpolicy). This article has been retracted at the request of the Editor-in-Chief as it contains fabricated/falsified data. The Editor-in-Chief decision was based on the investigation by the Japanese Society of Anesthesiologists which concluded that no research was conducted and all the data including patient backgrounds were fabricated. The investigation report can be found here.

RETRACTED: Rhomboid intercostal and subserratus plane block for transapical transcatheter aortic valve implantation

RETRACTED: Rhomboid intercostal and subserratus plane block for transapical transcatheter aortic valve implantation

VD01 A CASE OF “VERY” SIMULTANEOUS TRANSAPICAL TRANSCATHETER AORTIC AND MITRAL VALVE IMPLANTATION

Abstract The ever widening diffusion of biological prostheses and the achievement of higher mean age have focused attention on new possible scenario: off-label use of transcatheter valve implantation (TAVI) via a valve-in-valve procedure as an alternative strategy to standard surgery redo valve replacement. We report the first simultaneous Transapical Transcatheter Aortic and Mitral Valve Implantation performed after contemporary wires positioning in aortic and mitral size. After apical puncture, soft and subsequent stiff guidewires were inserted trans-apically through the 2 prosthesis. The first wire was advanced through the aortic prosthesis and placed in femoral artery. The second one was inserted through the mitral prosthesis and placed in right superior pulmonary vein. The aortic prosthesis was introduced through a trans-apically placed sheath, positioned, and then deployed into the degenerated aortic bioprosthesis under fluoroscopic guidance. The same procedure was used for mitral prosthesis using the previous positioned wire.

VD20 TWO-STAGES POSITIONING AND INFLATION OF THE BALLOON EXPANDING THE BIOPROSTHESIS IN TRANSCATHETER AORTIC VALVE IMPLANTATION IN A SMALL PORCELAIN AORTA

Abstract We propose a two-stages positioning and inflation of the balloon expanding the Edwards SAPIEN 3 prosthesis during Transcatheter Aortic Valve Implantation (TAVI) in case of a small porcelain aorta, to avoid aortic root (AR) rupture. We scheduled for Trans-apical TAVI an 85-year-old high-risk woman with a narrow and heavily calcified AR (19 × 20 mm at sino-tubular junction). A 23 mm Edwards Sapien3 prosthesis was directly implanted (without pre-valvuloplasty). First balloon-dilatation was performed in standard position till 70% of nominal inflation volume, in order to hook the prosthesis within the native calcified valve in the correct position. Then the balloon was completely deflated and withdrawn down into the left ventricle, with the distal tip just below the calcified and small aortic sino-tubular junction. In this position, a second balloon-dilatation was performed till 100% of nominal inflation volume to complete prosthesis expansion. Peri-operative trans-esophageal echocardiography showed no paravalvular leak and good trans-prosthesis gradients.

Changes in left ventricular function in patients with aortic regurgitation 12 months after transapical transcatheter aortic valve implantation.

Transcatheter aortic valve implantation (TAVI) is an established treatment for high surgical risk aortic stenosis patients; in recent years, it has also been used in patients with pure/dominant aortic regurgitation (AR). This study aimed to determine the impact of transapical TAVI on left ventricle myocardial mechanics in AR patients. Thirty AR patients (70% men; mean age, 72.8 ± 4.3years) were enrolled. Conventional echocardiography was performed on all patients before and 12months after TAVI. Three-dimensional speckle tracking was accomplished in 20 AR patients for the evaluation of global longitudinal strain, global circumferential strain, twist, torsion, apical rotation and basal rotation. Preoperative left ventricular ejection fraction (LVEF), global longitudinal strain (GLS), global circumferential strain (GCS), twist, torsion and apical rotation were impaired in AR patients compared with controls. Mean left ventricular (LV) end-diastolic diameter (from 62.9 ± 7.3 to 52.0 ± 6.8mm, p < 0.001), LV end-diastolic volume (from 199.4 ± 55.0 to 130.1 ± 48.9mL, p < 0.001), and LV mass index (179.8 ± 52.2-134.4 ± 42.5g/m2, p = 0.001) decreased 12months after TAVI. Interestingly, GLS (from - 17.2 ± 3.2 to - 18.9 ± 3.7, p = 0.007) and GCS (from - 23.9 ± 4.9 to - 25.7 ± 5.0, p = 0.008) improved significantly, but LVEF did not significantly improve. In terms of the rotational mechanics, twist, rotation and basal rotation remained almost unchanged, whereas apical rotation (from 7.4 ± 4.0 to 5.5 ± 3.9, p = 0.009) was significantly impaired after transapical TAVI. Our results indicate that LV function was improved in terms of myocardial deformation but worsened in terms of apical rotation 12months after TAVI in AR patients. Three-dimensional speckle tracking echocardiography appears to be a sensitive method for detecting subtle cardiac remodeling after TAVI.

Comparison of Outcomes of Transfemoral Versus Transapical Approach for Transcatheter Aortic Valve Implantation

Post hoc analyses of clinical trials have shown superior outcomes for a transfemoral (TF) compared with a transapical (TA) approach for transcatheter aortic valve implantation (TAVI). There are few contemporary data on utilization and outcomes of TF versus TA TAVI in real-world patient populations. Using the National Inpatient Sample 2011 to 2014, we identified TF-TAVI and TA-TAVI procedures using ICD-9 procedure codes 35.05 and 35.06, respectively. A propensity-matched cohort of TF and TA TAVI procedures balanced on 23 baseline characteristics was assembled. Outcomes included in-hospital mortality, acute kidney injury (AKI), AKI requiring dialysis (AKI-D) and postoperative stroke. A total of 7,973 TAVI procedures representative of 39,745 procedures nationally were included in the study. Of these, 80.2% were performed using a TF approach while 19.8% used a TA approach. Patients in the TF-TAVI group were older (mean age 81.7 vs 80.4 years, p < 0.001), with a higher prevalence of heart failure (12.7% vs 7.6%, p < 0.001) and lower prevalence of peripheral vascular disease (28.0% vs 35.5%, p < 0.001) compared with the TA-TAVI group. In 1,576 propensity-matched pairs of TF-TAVI and TA-TAVI procedures, TF-TAVI was associated with significantly lower in-hospital mortality (odds ratio [OR] 0.61, 95% confidence interval [CI] 0.42 to 0.88, p = 0.01), lower rates of AKI (0.53, 95% CI 0.44 to 0.63, p < 0.001), similar rates of AKI-D (OR 0.77, 95% CI 0.44 to 1.38, p = 0.38) and postoperative stroke (OR 1.19, 95% CI 0.67 to 2.10, p = 0.56) compared with TA-TAVI. In conclusion, TF-TAVI is associated with lower rates of in-hospital mortality and AKI compared with TA-TAVI. A TF approach should be preferred over a TA approach for TAVI whenever possible.

Comparison of Causes and Associated Costs of 30-Day Readmission of Transcatheter Implantation Versus Surgical Aortic Valve Replacement in the United States (A National Readmission Database Study)

Our current knowledge about comparative differences in 30-day readmissions and the impact of readmissions on overall costs after transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) is largely derived from clinical trials. The objectives of this study were to compare readmissions and costs for TAVI and SAVR in a nationally representative population-based sample. The Healthcare Cost and Utilization Project's National Readmission Database was used for the study. Hierarchical multivariable regression analyses were used to examine differences in the propensity score 1:1 matched cohort. The matched cohort included 4,682 patients who survived index procedures done from January through November 2013. Compared with SAVR, the rate of 30-day readmission was not significantly different for endovascular TAVI (16% vs 18%; p = 0.19); and was higher for the transapical TAVI (22% vs 17%; p <0.01) group. The 30-day cumulative costs were higher for the 2 endovascular TAVI ($51,025 vs $46,228; p = 0.03) and transapical TAVI ($59,575 vs $45,792; p <0.01). In multivariable analyses, the risk of 30-day readmission was similar for endovascular TAVI (odds ratio [OR] 0.93; 95% confidence interval [CI] 0.78 to 1.12) and was 27% higher for transapical TAVI (OR 1.27; 95% CI 1.02 to 1.57). Cumulative costs (index plus readmission costs) were 13% (β 0.13; 95% CI 0.10 to 0.15) and 19% (β 0.19; 95% CI 0.16 to 0.23) higher for the endovascular TAVI and transapical TAVI, respectively. In conclusion, the rate of readmissions was similar for endovascular TAVI and SAVR but the costs were 26% higher for TAVI than for SAVR.

Minimally invasive versus transapical versus transfemoral aortic valve implantation: A one-to-one-to-one propensity score–matched analysis

ObjectivesAlthough transcatheter aortic valve implantation was the treatment of choice in inoperable and high-risk patients, the effect of transcatheter aortic valve implantation relative to conventional aortic valve replacement via ministernotomy in patients with moderate surgical risk remains unclear. MethodsWe consecutively enrolled patients who underwent minimally invasive aortic valve replacements via ministernotomy (n = 1929), transapical (n = 607), and transfemoral (n = 1273) aortic valve implantations from a single center during the period from July 2009 to July 2017. Of those, we conducted a 1:1:1 propensity score matching according to 23 preoperative risk factors. ResultsWe were able to find 177 triplets (n = 531). The median European System for Cardiac Operative Risk Evaluation II was 3.0% versus 3.4% versus 2.9%, and Society of Thoracic Surgeons Predicted Risk of Mortality was 3.2% versus 3.6% versus 3.4%, respectively. According to the Valve Academic Research Consortium 2 criteria, there were no significant periprocedural differences regarding 30-day mortality (2.3% minimally invasive aortic valve replacement vs 4.5% transapical transcatheter aortic valve implantation vs 1.7% transfemoral transcatheter aortic valve implantation, P = .34), stroke (1.1% minimally invasive aortic valve replacement vs 0.6% transapical transcatheter aortic valve implantation vs 1.7% transfemoral transcatheter aortic valve implantation, P = .84), or myocardial infarction (0.6% minimally invasive aortic valve replacement vs 0.0% transapical transcatheter aortic valve implantation vs 0.0% transfemoral transcatheter aortic valve implantation, P = .83). Both intensive care and hospitalization times were significantly longer in the transapical group. Regarding midterm survival, transapical transcatheter aortic valve implantation was associated with a tendency toward a less favorable outcome (hazard ratio, 1.48; 95% confidence interval, 0.95-2.31; P = .17) compared with minimally invasive aortic valve replacement. ConclusionsIn this real-world propensity score–matched minimally invasive aortic valve replacement, transapical transcatheter aortic valve implantation, transfemoral transcatheter aortic valve implantation cohort of intermediate-risk patients, early mortality was not significantly different, whereas the rates of periprocedural complications were different depending on the approach. During follow-up, there was a tendency in the transapical transcatheter aortic valve implantation group toward a less favorable survival outcome, although there was no significant difference among the 3 groups.

RETRACTED: Transapical transcatheter aortic valve implantation performed with an erector spinae plane block

RETRACTED: Transapical transcatheter aortic valve implantation performed with an erector spinae plane block

Continuous PECS II block for postoperative analgesia in patients undergoing transapical transcatheter aortic valve implantation

It has been reported that PECS II block can alleviate postoperative pain following transapical transcatheter aortic valve implantation (TA-TAVI). However, the effectiveness of continuous PECS II block with catheterization has not yet been reported on the postoperative pain in patients undergoing TA-TAVI. We experienced two cases of TA-TAVI who received PECS II block with catheterization to manage postoperative pain. In the first case, a bolus injection for intraoperative pain and subsequent catheterization were performed before the implantation. However, the patient developed severe pain postoperatively in spite of the continuous block due to displacement of the catheter. In the second case, a bolus injection and the catheterization for the continuous block were performed before and after the implantation, respectively, which provided high-quality pain control. Continuous PECS II block may be useful to control perioperative pain associated with TA-TAVI. The insertion of the catheter after the implantation could be useful to avoid its displacement during the surgery.

Cost effectiveness of transcatheter aortic valve implantation in patients with aortic stenosis in Japan

BackgroundTranscatheter aortic valve implantation (TAVI) is a less invasive treatment for elderly patients with aortic stenosis. However, the cost of TAVI is a major issue. This study analyzed the cost effectiveness of TAVI in Japan. MethodsWe developed an economic model to evaluate the quality-adjusted life years (QALYs) and costs of TAVI, surgical aortic valve replacement (SAVR), and medical therapy over a 10-year time horizon from the perspective of Japanese public healthcare payers. The first model compared transapical or transfemoral TAVI with Sapien valve implantation and medical therapy in inoperable patients. The second model compared transfemoral TAVI with Sapien XT valve implantation and SAVR in operable patients with intermediate surgical risk. We assumed a cost-effectiveness threshold of 5,000,000yen per QALY, and assessed the cost-effectiveness probability with 100,000 simulations. We performed a broad sensitivity analysis to assess the effect of uncertainty on our results. ResultsAmong inoperable patients, the incremental cost-effectiveness ratio for TAVI compared with medical therapy was 3,918,808yen per QALY. In operable patients, the incremental cost-effectiveness ratio for TAVI compared with SAVR was 7,523,821yen per QALY. The cost-effectiveness probability of TAVI was 60% for inoperable patients and 46% for operable patients. Among inoperable patients, the cost-effective threshold of TAVI was <7,759,085yen. Among operable patients, the cost-effective threshold of TAVI was <5,427,439yen. ConclusionsThis study suggests that TAVI has good cost effectiveness for inoperable patients, but not for operable patients.

Balloon-expandable transaortic transcatheter aortic valve implantation with or without predilation

ObjectiveIt has been reported that balloon aortic valvuloplasty immediately before transfemoral or transapical transcatheter aortic valve implantation has mostly little to no clinical value. We aimed to provide data on the need for balloon aortic valvuloplasty in patients undergoing transaortic transcatheter aortic valve implantation. MethodsPatients undergoing transaortic transcatheter aortic valve implantation with the Edwards SAPIEN XT (Nyon, Switzerland) or 3 transcatheter heart valve were prospectively included at 18 sites across Europe. In the present analysis, we compare the periprocedural and 30-day outcomes of patients undergoing conventional (+ balloon aortic valvuloplasty) versus direct (− balloon aortic valvuloplasty) transaortic transcatheter aortic valve implantation. ResultsOf the 300 patients enrolled, 222 underwent conventional and 78 underwent direct transaortic transcatheter aortic valve implantation. Peak and mean transvalvular gradients were improved in both groups with no significant difference between groups. Procedural duration, contrast agent volume, and requirement for postdilation were also comparable. A trend toward fewer periprocedural complications was evident in the direct group (3.9% vs 11.3%; P = .053), with significantly lower rates of permanent pacemaker implantation (0% vs 5.0%; P = .034). Balloon aortic valvuloplasty omission had no significant effect on any of the 30-day safety and efficacy outcomes, including Valve Academic Research Consortium-2 composite end points (early safety events: 22.7% vs 17.4%, odds ratio, 1.17, 95% confidence interval, 0.53-2.62; clinical efficacy events: 20.5% vs 18.7%, odds ratio, 1.14, 95% confidence interval, 0.51-2.55). ConclusionsFor many patients, balloon aortic valvuloplasty predilation seems to have little clinical value in transaortic transcatheter aortic valve implantation using a balloon expandable transcatheter valve and may result in a higher rate of periprocedural complications, particularly in terms of permanent pacemaker implantation.

EuroSCORE II and the STS score are more accurate in transapical than in transfemoral transcatheter aortic valve implantation.

The European System for Cardiac Operative Risk Evaluation II (EuroSCORE II) and the Society of Thoracic Surgeons (STS) score are currently used to estimate periprocedural risk of death in patients undergoing transcatheter aortic valve implantation (TAVI). However, data regarding the predictive ability and usefulness of these scores for TAVI are controversial, especially for different access sites. Between 2008 and 2016, 1192 consecutive patients undergoing TAVI [transfemoral (TF): n = 607 (51%); transapical (TA): n = 585 (49%)] at 2 centres were included. All-cause mortality was assessed at a median of 533 days (interquartile range 153-1036). The value of the EuroSCORE II and the STS score in terms of predicting 30-day and cumulative mortality according to access site was investigated. The mean age was 83 (interquartile range 79-86) years. Overall, the 30-day mortality rate was 7.6% (n = 90), and the cumulative all-cause mortality rate was 35.1% (n = 418). The EuroSCORE II and the STS score were significantly increased in non-survivors compared with survivors (P < 0.001). The EuroSCORE II and the STS score emerged as independent predictors of 30-day mortality [EuroSCORE II: odds ratio (OR) 1.039, 95% confidence interval (CI) 1.013-1.065; P = 0.003; STS score: OR 1.055, 95% CI 1.023-1.088; P = 0.001] and cumulative all-cause mortality [EuroSCORE II: hazard ratio (HR) 1.026, 95% CI 1.013-1.038; P < 0.001; STS score: HR 1.05, 95% CI 1.03-1.06; P < 0.001]. In contrast to TF TAVI, the EuroSCORE II (OR 1.038, 95% CI 1.009-1.068; P = 0.010) and the STS score (OR: 1.063, 95% CI 1.025-1.102; P = 0.001) were independent predictors of 30-day mortality and cumulative mortality (EuroSCORE II: HR 1.023, 95% CI 1.009-1.037; P = 0.001; STS score: HR 1.055, 95% CI 1.037-1.073; P < 0.001) in patients undergoing TA TAVI. The EuroSCORE II and the STS score were independent predictors of 30-day and cumulative mortality rates in patients undergoing TAVI. The EuroSCORE II and the STS score were associated with 30-day mortality and mortality during follow-up period only in TA TAVI.

Transapical transcatheter aortic valve implantation in patients with a low ejection fraction.

It may be expected that patients with left ventricular dysfunction may be at greater risk of complications after transcatheter aortic valve implantation (TAVI) via transapical (TA) access compared with via transfemoral (TF) access. There is a lack of data comparing the outcomes of TAVI using TA and TF access in patients with a reduced left ventricular ejection fraction (EF). This is a retrospective analysis of data from a high-volume heart centre in Germany. TAVI access route assignment was based on a 'best for TF' approach, where only patients who met a strict set of criteria underwent TF-TAVI, with the remainder receiving TA-TAVI. For this analysis, patients were included if they had a pre-TAVI EF of ≤ 40%. Early mortality and late (1-year) mortality were compared through multivariate logistic regression. A total of 342 patients in the registry had an EF of ≤ 40%, of which 74.9% underwent TA-TAVI and 25.1% underwent TF-TAVI. Higher proportions of the TA group presented with certain comorbidities, and their logistic EuroSCORE and Society of Thoracic Surgeons (STS) risk scores were higher than in the TF group. At 1 year, TA access was associated with greater mortality in the univariate analysis (odd ratio 2.43; 95% confidence interval 1.04-5.69). However, after multivariate adjustment, no significant differences were found in either 30-day or 1-year mortality rates. The data suggest that, for patients with a reduced EF, TA-TAVI is not associated with a poorer outcome compared with TF-TAVI. Therefore, TA access should not be discounted based on the presence of left ventricular dysfunction alone.

Transapical approach for transcatheter aortic valve implantation.

With the advancement of device technology and procedural techniques, most transcatheter aortic valve implantation (TAVI) procedures have been performed with the transfemoral approach in recent years (1). However, alternative approaches such as transapical, trans-subclavian, direct aortic and others still play an important role in patients with poor vascular access. Transapical approach is the only antegrade approach and provides easy wiring and excellent controllability. In contrast, the transapical approach has some potential drawbacks including apical bleeding risk and postoperative pain. Herein, we introduce technical tips for fast and safe transapical TAVI.

Identification of Periprocedural Myocardial Infarction Using a High-Sensitivity Troponin I Assay in Patients Who Underwent Transcatheter Aortic Valve Implantation

Periprocedural myocardial infarction (MI), a rare complication after transcatheter aortic valve implantation (TAVI), is associated with worse outcome. According to the Valve Academic Research Consortium (VARC-2), MI is defined by an increase in cardiac troponin (cTn) and creatine kinase MB (CK-MB) levels; however, many patients show periprocedurally elevated cTn without clinical evidence of MI. The aims of this study were to establish reference values of cardiac troponin I measured with a high-sensitivity assay (hs-cTnI) and to assess the periprocedural diagnostic value of this biomarker in patients who underwent TAVI. Hs-cTnI and CK-MB levels were assessed before and up to 3 days after transfemoral (TF) or transapical (TA) TAVI in 515 patients. A high proportion (61.2%) of patients had elevated hs-cTnI at baseline. According to VARC-2 criteria, almost all TA-patients (99.5%) showed an MI based on hs-cTnI compared with 4.2% based on CK-MB. In TF-patients, 81.1% had an MI based on hs-cTnI compared with 9.0% based on CK-MB. Only 10 patients (2%), however, had a type 1 MI. The ninety-ninth percentile for hs-cTnI was 285 ng/L in the TAVI cohort. After applying a TAVI-specific cutoff the frequency of MI was lower and more realistic (TF: 5% vs 81.1%; p <0.001; TA: 22.2% vs 99.5%; p <0.001). In conclusion, the VARC-2 definition leads to an overestimation of periprocedural MI. Our new TAVI-specific reference values yield a more realistic estimation of the myocardial ischemic risk. hs-cTnI, however, does not seem to be the biomarker of choice for MI detection in this setting.

Pitfalls in TAMVI: experience with the repositionable Lotus\xae Valve System

BackgroundSimultaneous transapical implantation of transcatheter heart valves in the native mitral and aortic position may be considered as an alternative to surgical valve replacement in high-risk patients presenting with combined valve disease.Case presentationA 59-year-old female with severe aortic stenosis, severe mitral stenosis with mild mitral insufficiency, persistent atrial fibrillation, severe chronic obstructive pulmonary disease and NYHA class of IV was evaluated by our interdisciplinary heart team. Due to the calculated Euroscore II, logistic Euroscore with 10% and 17% a decision was made towards a transapical TAVI approach. The implantation of a Sapien 3 (Edwards Lifesciences) valve in the aortic position was performed and the perioperative TEE showed a good result. The preoperative imaging revealed a narrow LVOT with risk for post interventional left ventricular outflow tract obstruction. Accordingly, it was decided against the use of balloon-expanding valves for the mitral valve position in the interdisciplinary team, as it is not repositionable. Instead, it was decided for the use of a Lotus (Boston Scientific) valve, as it is repositionable and therefore possible to retract in case of LVOT obstruction. In the present case of double valve intervention, the implantation attempt of a fully repositionable transcatheter heart valve into the native mitral annulus resulted in acute LVOT obstruction requiring immediate removal of the device. The patient was extubated and experienced uneventful postoperative recovery.ConclusionsThe case shows that improved preoperative work-up is necessary for better prediction of significant LVOT obstruction following transcatheter mitral valve implantation. In borderline cases, the use of a fully repositionable device is preferred.

Predictors of length of stay and duration of tracheal intubation after transcatheter aortic valve implantation.

While short-term outcomes for patients undergoing transcatheter aortic valve implantation (TAVI) have long been studied, there is very little data on their predictors. We aimed to identify the predictors of outcomes, such as intensive care unit (ICU) and in-hospital length of stay (LOS), duration of postoperative intubation and in-hospital mortality, after TAVI procedures. We conducted a retrospective cohort study of 162 consecutive patients with aortic valve disease, who were admitted to a tertiary hospital of Liverpool for TAVI, during a five-year period. The data was collected using of the hospital's structured database on November 2014. By using a multivariate analysis we found that any postoperative bleeding [odds ratio (OR) 2.71; 95% confidence interval (CI): 1.41-5.24] was the independent predictor of prolonged ICU-LOS, while older age (OR 1.11; 95% CI: 1.05-1.17) and transapical TAVI (OR 4.11; 95% CI: 1.94-8.71) were the predictors of prolonged in-hospital LOS. Additionally, patients treated with oral inotropic agents, preoperatively (OR 5.77; 95% CI: 2.21-15.01), non-diabetics (OR 3.07; 95% CI: 1.12-8.42) and those with any postoperative bleeding (OR 3.53; 95% CI: 1.68-7.43) had a significantly greater probability in remaining intubated postoperatively. The multivariate analysis did not reveal any predictor of in-hospital mortality. The above predictors permit the early identification of TAVI patients at high risk for longer hospitalization and increased mechanical ventilation. This piece of information is crucial for clinicians and administrators contributing to more efficient patient care planning and better allocation of healthcare resources.

Transaortic transcatheter aortic valve implantation as a first-line choice or as a last resort? An analysis based on the ROUTE registry.

Transaortic transcatheter aortic valve implantation (TAo-TAVI) is a recently developed alternative to transapical (TA) or transfemoral (TF) TAVI. We aimed to analyse the effectiveness and safety of TAo-TAVI as a first line approach and to compare it to patients receiving TAo-TAVI as a last resort, which is current practice. ROUTE is a prospective, multicentre registry to assess the clinical outcomes of TAo-TAVI. Patients without contraindications for TA- and TF-TAVI (TAo-first) were compared to patients with contraindications for both of these access routes (TAo-last). Outcome analysis was based on VARC II defined clinical end-points. Three hundred and one patients were included, of which 224 patients met TAo-first and 77 TAo-last criteria. The valve was delivered and catheter retrieved successfully in all patients. In the TAo-first group, rates of conversion to open surgery and requirement for a second valve were low and not different compared to TAo-last patients (1% vs. 3%, P = 0.46 and 1% vs. 3%, P = 0.46, respectively). This was also true for the rate of paravalvular regurgitation (≥ moderate: 4% vs. 3%). All-cause mortality at 30-days was 6% vs. 5% ( P = 0.76), rates of stroke 2% vs. 0% ( P = 0.24), pacemaker implantation (11% vs. 4%, P = 0.093), and life-threatening bleeding 4% vs. 3% ( P = 0.70). Valve safety (both 85%, P = 0.98) and clinical efficacy (80% vs. 82%; P = 0.73) did not differ between groups. Although comparative data to TA and TF procedures were not available in the present analysis, findings suggest that TAo may be considered not only as a last resort strategy when classical access routes are deemed unfeasible, but also as a potential first-line option, with only low rates of paravalvular regurgitation and permanent pacemaker implantation. NCT01991431.

Transapical transcatheter aortic valve implantation using the J-Valve system: A 1-year follow-up study

ObjectiveTranscatheter aortic valve implantation has become a routine procedure to treat screened inoperable or high-risk patients. In this study, we present the first outcome of echocardiographic midterm using a new second-generation transcatheter aortic valve implantation system, the J-Valve system (Jie Cheng Medical Technologies, Suzhou, China), in patients with aortic stenosis or aortic regurgitation. MethodsFrom July 2014 to June 2015, 21 patients with isolated aortic valve disease at high risk for open surgery received transapical transcatheter aortic valve implantation using the J-Valve system. The primary end point was a combined efficacy end point after 1 year, which included all-cause mortality after more than 30 days and failure of current therapy for aortic stenosis or aortic regurgitation requiring hospitalization for symptoms of valve-related cardiac decompensation or prosthetic heart valve dysfunction. Secondary end points were cardiovascular mortality, major stroke, and life-threatening, disabling, or major bleeding after 6 and 12 months. ResultsThe mean age of the study cohort was 75.52 ± 5.22 years, the European System for Cardiac Operative Risk Evaluation II score was 11.33% ± 1.28%, and the mean logistic European System for Cardiac Operative Risk Evaluation I score was 31.13% ± 9.68%. Transcatheter aortic valve implantation with the J-Valve system was successfully performed in 19 of the 21 patients (90.5%). For patients with aortic stenosis, 12-month follow-up echocardiography demonstrated an increase in mean effective valve area from 0.62 ± 0.17 cm2 to 1.52 ± 0.35 cm2 and a decrease in transvalvular mean gradient from 61 ± 15 mm Hg to 18 ± 9 mm Hg. All surviving patients (n = 18) reported improvements in at least 1 of the New York Heart Association classes. The combined ratio of successful implantation and absence of adverse events in our cohort (n = 21) was 76.19%. ConclusionsThe J-Valve system exhibits a convincing midterm performance and is a safe and feasible procedure with low perioperative and postoperative complications.