Direct Transcatheter Aortic Valve Implantation Research Articles

Balloon predilation or direct valve implantation in TAVI for women: Insights from the DIRECTAVI study.

The randomized DIRECTAVI trial demonstrated safety and feasibility of transcatheter aortic valve implantation (TAVI) without balloon aortic valvuloplasty (BAV) using SAPIEN 3 balloon-expandable devices. However, the female population with smaller anatomy may have potential higher risk of residual gradient and/or mismatch. We assessed the impact of BAV on the procedural success rate and clinical outcomes in the female population of the DIRECTAVI trial. Between May 2016 and May 2018, 91 of the 250 patients included in the DIRECTAVI trial were women (38.6%), 45 of them (49.5%) were enrolled in the BAV group and 46 of them (50.5%) in the direct TAVI group. The primary endpoint was procedural success rate in women (Valve Academic Research Consortium-2 criteria). The secondary endpoint included evaluation of PPM and 1-month major adverse events according to the implantation stategy in women and comparison between men and women regarding major endpoints. The primary endpoint occurred in 29 women (64.4%) in the BAV group and in 34 women (73.9%) in the direct TAVI group (mean difference 9.47%; 95% confidence interval: 6.5%-25.4%; p = 0.045 for non-inferiority of the direct strategy). One-month major adverse events were similar between the 2 women groups. Procedural success was lower in women vs men (p = 0.01) due to higher incidence of moderate mismatches in women (p = 0.001) but with no significant difference regarding the implantation strategy (p = 0.4). Direct implantation of the balloon-expandable SAPIEN 3 valve was non-inferior to predilatation on procedural success in women. Incidence of moderate mismatch was higher in women but was not related to the implantation strategy.

Direct vs. staged TAVI in the acute management of decompensated severe aortic stenosis

Abstract Funding Acknowledgements None. Background Transcatheter aortic valve implantation (TAVI) has emerged as a preferred treatment for severe aortic stenosis across a spectrum of surgical risks, potentially diminishing the role of balloon aortic valvuloplasty (BAV) as a transient solution or a bridge to definitive intervention. With advancements in TAVI technology and expertise, patients even in unstable conditions are increasingly receiving direct, definitive TAVI, avoiding the risks associated with staged, multiple procedures. Aims The study set out to assess whether immediate TAVI is safer and more effective than BAV followed by elective aortic valve replacement (AVR) in acute severe aortic stenosis. Methods Conducted as a retrospective analysis at a single center, this study encompassed a cohort of consecutive patients who received either urgent or emergency BAV, as bridge to AVR, or TAVI to manage decompensated severe aortic stenosis from May 2012 to May 2023. The primary outcomes were mortality rates at both 30 days and one year following the procedures. Results In this cohort, 258 cases of urgent or emergent percutaneous aortic valvuloplasty were evaluated. BAV was performed in 47 patients, whereas 211 received direct TAVI. A significantly higher proportion of the BAV group (36%) was treated due to cardiogenic shock as the primary indication, compared with just 11% in the TAVI group (p< 0.001). Demographic parameters and comorbid condition profiles were equivalently balanced across both groups. The median age was 81 years (interquartile range: 74-85, p= 0.40), and males constituted 56% of the patient population (p= 0.72). Most patients (65%) presented with left ventricular systolic dysfunction, and nearly half (49%) were diagnosed with obstructive coronary artery disease. The reduction in peak aortic valve gradient was significantly more pronounced in the TAVI group (-56±25 mmHg) compared to the BAV group (-27±19 mmHg, p< 0.001). TAVI recipients also had a higher incidence of VARC-2 minor and major bleeding events (26% versus. 6% for BAV, p<0.001), and a greater occurrence of advanced atrioventricular block necessitating temporary pacing (19% vs. 9% for BAV, p= 0.02). Thirty-day survival rates favored the TAVI group (93%) over BAV (86%). This trend persisted at the one-year mark, with survival rates of 84% for TAVI and 70% for BAV. Furthermore, the one-year hazard ratio for mortality among patients undergoing BAV was 2.01 (95% confidence interval: 1.34–3.01, p< 0.001). Conclusion The data from this retrospective analysis indicate that for patients with decompensated severe aortic stenosis, immediate TAVI may confer a mortality benefit over BAV followed by elective procedures. Despite a higher rate of procedural complications, the direct TAVI approach was associated with better survival rates at both 30 days and one year. These outcomes suggest a potential reevaluation of treatment strategies in acute settings may be warranted.

ACURATE neo2 Transcatheter aortic valve implantation without balloon aortic valvuloplasty - direct ACURATE neo2

BackgroundACURATE neo2 (Neo2) implantation is performed after systematic Balloon Aortic Valvuloplasty (BAV) in most patients. No reports exist about the feasibility and safety of direct Neo2 transcatheter aortic valve implantation (TAVI) in comparison to the standard practice. AimWe aimed to identify the patients' baseline anatomical characteristics, procedural, and early post-procedural outcomes in patients treated using Neo2 with and without BAV. MethodologyThis is a retrospective multicentre analysis of 499 patients with severe aortic stenosis who underwent TAVI using Neo2. The comparison was done according to the performance or omission of BAV. Echocardiography and computed tomography were analysed by an independent Core Lab. Propensity score matching (PSM) was performed based on the annular diameter and AV calcium volume, which identified 84 matched pairs. ResultsAmong the cohort included, 391 (78%) patients received BAV (BAV-yes) and 108 (22%) were not attempted (BAV-no or Direct TAVI). Patients in BAV-no cohort had smaller annular diameter (22.6 vs 23.4 mm; p < 0.001) and lower calcium volume (163 vs 581 mm3; p < 0.001) compared to BAV-yes cohort.In the matched cohort, VARC-3 device technical success was similar (95%) and all other outcome measures were statistically comparable between cohorts. ConclusionDirect TAVI using ACURATEneo2 without pre-TAVI balloon aortic valvuloplasty in patients with mild or less valve calcifications might be feasible and associated with comparable early outcomes compared to patients with similar anatomical features undergoing systematic balloon valvuloplasty.

Up to 6-year performance and clinical outcomes of balloon expandable transcatheter aortic valve according to the implantation strategy: insight from the DIRECTAVI trial

Abstract Background The randomized DIRECTAVI trial demonstrated safety and feasibility of transcatheter aortic valve implantation (TAVI) without balloon aortic valvuloplasty (BAV) using SAPIEN 3 balloon-expandable devices. Purpose To evaluate long-term clinical and hemodynamic results according to the implant strategy (direct TAVI versus BAV) with the SAPIEN 3 balloon-expandable device in patients included in the DIRECTAVI trial. Methods All patients included in the DIRECTAVI trial since 2016 were offered a clinical and echocardiographic follow-up until January 2023. We applied Valve Academic Research Consortium (VARC-3) criteria to define moderate/severe hemodynamic valve deterioration (HVD) as an increase in mean gradient ≥10 mm Hg resulting with a final mean gradient ≥20 mm Hg, or new/worsening aortic regurgitation (AR) of 1 grade resulting in ≥moderate AR. Survival until moderate/severe HVD between the 2 groups was the primary end-point and overall survival between direct TAVI and BAV were compared using logrank tests. Major clinical outcomes at latest follow-up were also assessed using Chi² or Fisher’s tests. Results Among 250 patients included in DIRECTAVI, 228 patients were followed-up during 4.5 ± 1.1 years. Mean age at follow-up was 87 ± 6.7 years. Incidence rates of moderate/severe HVD were similar in the 2 groups (1.45 versus 1.97 per 100 person-years, p=0.6) (Figure). Incidence rates for death were similar between groups (9.19 and 7.34 events per 100 persons-years for BAV and direct TAVI, respectively, p=0.4). No clinically significant differences in outcomes were observed at the latest follow-up, including major stroke (4.4% for BAV versus 2.6% for direct TAVI, p=0.7), hospitalizations for heart failure (15.8% for BAV group and 11.4% for direct TAVI group, p=0.3), permanent pacemaker implantation (37.7% for BAV and 31.6% for direct TAVI, p=0.3). Moderate/severe patient-prosthesis mismatch was also similar between groups (p=0.6). Conclusion Compared to systematic BAV, direct implantation of the SAPIEN 3 device was not associated with an increased risk of moderate/severe valve deterioration or adverse clinical events up to 6-year follow-up. These results encourage wide use of this simplified strategy with balloon-expandable devices, when possible.Survival without valve deterioration

Direct transcatheter aortic valve implantation (TAVI) decreases silent cerebral infarction when compared to routine balloon valvuloplasty.

Silent cerebral infarctions (SCI), as determined by neuron-specific enolase (NSE) elevations, may develop after the transcatheter aortic valve implantation (TAVI) procedure. Our aim in this study was to compare the SCI rates between patients who underwent routine pre-dilatation balloon aortic valvuloplasty (pre-BAV) and patients who underwent direct TAVI without pre-BAV. A total of 139 consecutive patients who underwent TAVI in a single center using the self-expandable Evolut-R valve (Medtronic, Minneapolis, Minnesota, USA) were included in the study. The first 70 patients were included in the pre-BAV group, and the last 69 patients were included in the direct TAVI group. SCI was detected by serum NSE measurements performed at baseline and 12h after the TAVI. New NSE elevations > 12 ng/mL after the procedure were counted as SCI. In addition, SCI was scanned by MRI (magnetic resonance imaging) in eligible patients. TAVI procedure was successful in all of the study population. Post-dilatation rates were higher in the direct TAVI group. Post-TAVI NSE positivity (SCI) was higher in the routine pre-BAV group (55(78.6%) vs. 43(62.3%) patients, p = 0.036) and NSE levels were also higher in this group (26.8 ± 15.0 vs. 20.5 ± 14.8 ng/ml, p = 0.015). SCI with MRI was found to be significantly higher in the pre-BAV group than direct TAVI group (39(55.1%) vs. 31(44.9%) patients). The presence of atrial fibrillation and diabetes mellitus (DM), total cusp calcification volume, calcification at arcus aorta, routine pre-BAV and failure at first try of the prosthetic valve implantation were significantly higher in SCI (+) group. In the multivariate analysis, presence of DM, total cusp calcification volume, calcification at arcus aorta, routine pre-BAV and failure at first try of the prosthetic valve implantation were significantly associated with new SCI development. Direct TAVI procedure without pre-dilation seems to be an effective method and avoidance of pre-dilation decreases the risk of SCI development in patients undergoing TAVI with a self-expandable valve.

Impact of balloon predilatation in patients with reduced versus preserved ejection fraction during transcatheter aortic valve implantation

Although there is a trend toward direct transcatheter aortic valve implantation (TAVI), still balloon predilatation is necessary in some cases, especially in patients with severe calcification. However, predilatation including rapid ventricular pacing may have adverse outcomes, especially in patients with reduced ejection factor (EF). To evaluate the impact of predilatation on in-hospital outcomes in patients with reduced versus preserved EF underwent TAVI. This was a prospective observational study including 110 patients (72 patients with preserved EF (≥50%) and 38 patients with reduced EF (<50%)) who underwent TAVI. The two groups were compared regarding in-hospital outcomes. Predilatation was done routinely in all 110 patients. The mean age was significantly higher in patients with preserved EF (82.76 ± 5.74 vs. 80.13 ± 6.51 years; p = 0.03). The majority (51.4%) of patients with preserved EF were females but the majority (73.7%) of those with reduced EF were males (P < 0.001). Predilatation showed no statistical difference regarding in-hospital mortality (2.6% vs. 1.4%; p = 0.29), hemodynamic instability (5.3% vs. 0.0%; p = 0.11), stroke (0% vs. 1.4%; p = 0.67), conduction defects (13.2% vs. 19.4%; p = 0.29), permanent pacemaker implantation (7.9% vs. 5.5%; p = 0.45), paravalvular leakage (5.3% vs. 2.8%; p = 0.42), vascular complications (7.9% vs. 11.1%; p = 0.43), and acute kidney injury (7.9% vs. 7%; p = 0.4) in patients with reduced versus preserved EF, respectively. When balloon predilatation is inevitable during TAVI it is safe in patients with reduced as well as preserved EF with no added risk of hemodynamic instability or other outcomes.

How to use the aortic valve calcium score to improve the results of transcatheter aortic valve implantation with a self-expanding prosthesis

In recent years, transcatheter aortic valve implantation (TAVI) without predilation (direct TAVI) has become the preferred method for implanting TAVI prostheses. Appropriate patient selection is important to avoid suboptimal outcomes and associated complications. To evaluate whether aortic valve calcification measured with computed tomography predicts suboptimal results from direct TAVI with a self-expanding prosthesis. Single-centre retrospective analysis of patients who received a CoreValve™ prosthesis (Medtronic, Minneapolis, MN, USA) in a direct TAVI procedure between January 2018 and March 2019. Aortic valve calcification assessment (aortic valve calcium score, calcium volume and calcium mass) was calculated from the computed tomography scan before TAVI. Procedural characteristics, need for postdilation and complications were analysed. Of 168 included patients, 18 were postdilated. Aortic valve calcium score (4259 vs. 2578; P<0.001), calcium volume (1184 vs. 647mm3; P<0.001) and calcium mass (642 vs. 368mg; P<0.001) were higher in patients needing postdilation. Aortic valve calcium score (odds ratio 9.73; P=0.004), calcium volume (odds ratio 8.48; P=0.006) and calcium mass (odds ratio 6.21; P=0.006) were independent predictors of suboptimal direct TAVI outcomes. A high aortic valvular calcium score, assessed by computed tomography scan, is an independent predictor of suboptimal prosthesis implantation outcomes in direct TAVI.

Transcatheter Aortic Valve Implantation With or Without Predilation: A Meta-Analysis.

To evaluate the impact of systematic predilation with balloon aortic valvuloplasty (BAV) on transcatheter aortic valve implantation (TAVI). We performed a systematic meta-analysis investigating patients undergoing TAVI with systematic BAV vs no BAV in RCT or in adjusted studies. Device success was the primary endpoint, while all-cause mortality, 30-day moderate/severe aortic regurgitation (AR), stroke, permanent pacemaker implantation (PPI) and acute kidney injury (AKI) were the secondary endpoints. Subanalysis according to design of the study (RCT and adjusted analysis) and to the type of valve (balloon-expandable [BE] vs self-expanding [SE]) were conducted. We obtained data from 15 studies, comprising 16,408 patients: 10,364 undergoing BAV prior to TAVI and 6,044 in which direct TAVI has been performed. At 30-day follow-up, BAV did not improve the rate of device success in the overall population (OR, 1.09; 95% CI, 0.90-1.31), both in SE (OR, 0.93; 95% CI, 0.60-1.45) and in BE (OR, 1.16; 95% CI, 0.88-1.52) valves. Between BAV and direct TAVI, no differences in secondary outcomes were observed neither in overall population nor according to valve type between BAV and direct TAVI strategies. All endpoints results were consistent between RCTs and adjusted studies except for postdilation rate that did not differ in observational studies (OR, 0.70; 95% CI, 0.47-1.04), while it was lower in BAV when only RCTs were included in the analysis (OR, 0.48; 95% CI, 0.24-0.97). Direct TAVI is feasible and safe compared to predilation approach with similar device success rates and clinical outcomes. Direct TAVI could represent a first-choice approach in contemporary TAVI procedures.

Management strategies for acutely decompensated aortic stenosis

Abstract Background Uncertainty exists over the optimal treatment strategy for patients presenting with acutely decompensated severe aortic stenosis (AS). The available options include a bridging balloon aortic valvuloplasty (BAV) or a direct transcatheter aortic valve implantation (TAVI). Purpose Our study compares TAVI outcomes in patients treated with two different strategies in acutely decompensated severe AS: bridged TAVI vs direct TAVI. Methods In this observational study all patients admitted with decompensated severe AS who underwent balloon aortic balloon valvuloplasty (BAV) and/or TAVI on the index admission were included. Comparison was made between bridged TAVI group (defined as initial BAV followed by TAVI) and direct TAVI group (TAVI on the index admission without bridging BAV). For this analysis we excluded patients in cardiogenic shock. Baseline characteristics, echocardiographic and periprocedural data were recorded in hospital database. Major adverse cardiovascular events (MACE) were defined as death, major bleeding, rehospitalisation for heart failure, or stroke). The follow-up data was obtained by outpatient visits and/or telephone calls. Results 178 patients with acutely decompensated AS were analysed: 58 bridged TAVI, 23 direct TAVI, 9 bridged SAVR and 88 destination BAV (defined as BAV non followed by a definite treatment). There was no statistically significant difference between bridged TAVI and direct TAVI group in mean age (83.6±6.6 vs 80.4±8.3 years), the prevalence major comorbidities (coronary, respiratory, neurological or peripheral vascular disease), renal function (eGFR 43.4±18.9 vs 45.2±20.9 ml/min/m2), the mean LV ejection fraction (53.4±13.8 vs 48.6±14.6%) or aortic valve gradient (39.4±13.0 vs 34.1±12.3mmHg), respectively. Direct TAVI patients had a higher mean surgical risk scores (STS 6.1±3.7 vs 9.1±7.0%, logES 18.8±11.5 vs 30.8±20.9%, p=0.01) and higher prevalence of significant aortic regurgitation (5% vs 43%, p=0.0001). The femoral TAVI access was used in 98% of bridged and 78% of direct TAVI patients (p=0.006). The estimated 1-year survival and 1-year MACE-free survival did not differ significantly between the bridged TAVI and direct TAVI groups (86.8% vs 78.3%, p=0.20 and 79.7% vs 64.2%, p=0.11, respectively). Conclusions A large proportion of patients admitted with acutely decompensated AS were not eligible for definite treatment. There is no difference in procedural success, 1-year all-cause mortality and 1-year major adverse cardiovascular events between the bridged TAVI or direct TAVI strategies in acute decompensated aortic stenosis allowing to personalize treatment strategy for individual patient. Funding Acknowledgement Type of funding sources: None. Table 1. Clinical and procedural data

Prior Balloon Valvuloplasty Versus Direct Transcatheter Aortic Valve Replacement: Results From the DIRECTAVI Trial

ObjectivesThe aim of this study was to evaluate device success of transcatheter aortic valve replacement (TAVR) using new-generation balloon-expandable prostheses with or without balloon aortic valvuloplasty (BAV). BackgroundRandomized studies are lacking comparing TAVR without BAV against the conventional technique of TAVR with BAV. MethodsDIRECTAVI (Direct Transcatheter Aortic Valve Implantation) was an open-label noninferiority study that randomized patients undergoing TAVR using the Edwards SAPIEN 3 valve with or without prior balloon valvuloplasty. The primary endpoint was the device success rate according to Valve Academic Research Consortium-2 criteria, which was evaluated using a 7% noninferiority margin. The secondary endpoint included procedural and 30-day adverse events. ResultsDevice success was recorded for 184 of 236 included patients (78.0%). The rate of device success in the direct implantation group (n = 97 [80.2%]) was noninferior to that in the BAV group (n = 87 [75.7%]) (mean difference 4.5%; 95% confidence interval: −4.4% to 13.4%; p = 0.02 for noninferiority). No severe prosthesis-patient mismatch or severe aortic regurgitation occurred in any group. In the direct implantation group, 7 patients (5.8%) required BAV to cross the valve. Adverse events were related mainly to pacemaker implantation (20.9% in the BAV group vs. 19.0% in the direct implantation group; p = 0.70). No significant difference was found between the 2 strategies in duration of procedure, contrast volume, radiation exposure, or rate of post-dilatation. ConclusionsDirect TAVR without prior BAV was noninferior to the conventional strategy using BAV with new-generation balloon-expandable valves, but without procedural simplification. BAV was needed to cross the valve in a few patients, suggesting a need for upstream selection on the basis of patient anatomy. (TAVI Without Balloon Predilatation [of the Aortic Valve] SAPIEN 3 [DIRECTAVI]; NCT02729519)

Transcatheter Aortic Valve Implantation With the Third Generation Balloon-Expandable Bioprosthesis in Patients With Severe Landing Zone Calcium

Device success of earlier generation balloon-expandable transcatheter heart valves (BE-THV) is lower in patients with severe landing zone calcium (LZC). We sought to explore the impact of LZC on the outcome of transcatheter aortic valve implantation (TAVI) with the next generation Edwards Sapien 3 BE-THV. In the present study, severe LZC was defined as severe aortic valve cusp calcium (AVC) and/or left ventricular outflow tract calcium (LVOTC) on computed tomography. Patients who underwent TAVI for pure/predominant aortic regurgitation, bicuspid aortic valve disease, or failed bioprosthetic valve were excluded. Out of 350 patients who underwent TAVI with the Edwards Sapien 3 (age 80.7 ± 6.1, female: 45.1%, Society of Thoracic Surgeons score: 4.9 ± 3.8, transfemoral: 97.4%), 106 (30.3%) had severe LZC; 78 severe AVC (22.3%) and 49 severe LVOTC (14.0%). Severe LZC was associated with lower device success (96.2% vs 100%, p = 0.008) driven by more prosthetic valve regurgitation (PVR, p = 0.008). On multivariable analysis, PVR was associated with severe LVOTC (odds ratio [95% confidence interval] 2.130 [1.092 to 4.158]) but not with severe AVC (1.529 [0.835 to 2.800]). Balloon predilatation (BPreD) was performed in 42.5% of patients with severe LZC (vs 19.3% in nonsevere LZC; p <0.001) and was associated with prolonged procedural time (p = 0.001) and higher irradiation exposure (p = 0.027). Device success (p = 0.311), major procedural complications (p = 0.132), 30-day safety end point (p = 0.815), and PVR (p = 0.684) were not significantly different between patients with severe LZC who underwent BPreD versus direct TAVI. In conclusion, device success of the third generation BE-THV is lower in severe LZC driven by more PVR, especially in patients with severe LVOTC. In those patients, BPreD prolonged the procedure without improving THV performance.

Prior balloon valvuloplasty versus DIRECT transcatheter Aortic Valve Implantation (DIRECTAVI): study protocol for a randomized controlled trial

BackgroundBalloon predilatation of the aortic valve has been regarded as an essential step during the transcatheter aortic valve implantation (TAVI) procedure. However, recent evidence has suggested that aortic valvuloplasty may cause complications and that high success rates may be obtained without prior dilatation of the valve. We hypothesize that TAVI performed without predilatation of the aortic valve and using new-generation balloon-expandable transcatheter heart valves is associated with a better net clinical benefit than TAVI performed with predilatation.Methods/designThe transcatheter aortic valve implantation without prior balloon dilatation (DIRECTAVI) trial is a randomized controlled open label trial that includes 240 patients randomized to TAVI performed with prior balloon valvuloplasty (control arm) or direct implantation of the valve (test arm). All patients with an indication for TAVI will be included excepting those requiring transapical access. The trial tests the hypothesis that the strategy of direct implantation of the new-generation balloon-expandable SAPIEN 3 valve is noninferior to current medical practice using predilatation of the valve. The primary endpoint assessing efficacy and safety of the procedure consists of immediate procedural success and secondary endpoints include complications at 30-day follow-up (VARC-2 criteria). A subgroup analysis evaluates neurological ischemic events with cerebral MRI imaging (25 patients in each strategy group) performed before and between 1 and 3 days after the procedure.DiscussionThis prospective randomized study is designed to assess the efficacy and safety of TAVI performed without prior dilatation of the aortic valve using new-generation balloon-expandable transcatheter heart valves. We aim to provide robust evidence of the advantages of this strategy to allow the interventional cardiologist to use it in everyday practice.Trial registrationClinicalTrials.gov identifier: NCT02729519. Registered on 15 July 2016.

Predilatation Prior to Transcatheter Aortic Valve Implantation: Is it Still a Prerequisite?

Predilatation has been historically considered a mandatory step before transcatheter aortic valve implantation (TAVI) since it facilitates valve crossing and prosthesis delivery, ensures optimal valve expansion and improves hemodynamic stability during valve deployment. However, as a result of procedural evolution over time, direct TAVI (without pre-implantation balloon aortic valvuloplasty) has emerged as an interesting option to simplify the procedure and to avoid potential valvuloplasty-related complications. Several real-world retrospective studies and one small randomised study have shown that direct TAVI (with both self-expanding and balloon-expandable prostheses) is feasible, safe and associated with outcomes similar to standard TAVI with pre-implantation balloon aortic valvuloplasty. In the absence of high-quality, robust evidence, the current review aims to discuss the advantages and disadvantages of omitting predilatation prior to TAVI.

Comparison of Systematic Predilation, Selective Predilation, and Direct Transcatheter Aortic Valve Implantation With the SAPIEN S3 Valve

BackgroundDespite previously described feasibility, direct transcatheter aortic valve implantation (TAVI) with the Edwards SAPIEN S3 device (S3-THV) (Edwards Lifesciences, Irvine, CA) has not been compared with either a systematic or a selective predilation approach. MethodsPatients undergoing predilation were divided into a systematic group (regardless of anatomic features) and a selective group (in the context of high valvular calcium burden). Both groups were matched in a 2:1 fashion to patients who underwent direct TAVI. Outcomes were assessed according to Valve Academic Research Consortium 2 (VARC-2) criteria. ResultsTwo hundred eighty-one patients underwent TAVI with the S3-THV in our centre. Of these patients, 58 underwent predilation before device implantation (systematic, n = 26; selective, n = 32). Procedural success was achieved in all patients. Patients in the selective predilation group had severe valve calcification volume—more than double that of the systematic group (445 ± 306 mm3 vs 970 ± 578 mm3, respectively; P < 0.0001).There was a trend for less dilation after the procedure in the systematic group compared with the selective group (4% vs 19%, respectively; P = 0.09). Device malposition necessitating a second device to be implanted occurred in 3 cases of direct TAVI (5%) and in none of the patients undergoing predilation (P = not significant). Thirty-day and 1-year mortality rates were similar between the patients who underwent direct TAVI and their predilation counterparts. ConclusionsIn patients with a moderate aortic valve calcification burden, direct TAVI appears to be feasible and safe. In those with high calcium burden, predilation should be considered after taking into account individual risk profiles.

Direct transfemoral transcatheter aortic valve implantation without balloon pre-dilatation using the Edwards Sapien XT valve.

To evaluate the feasibility and safety of direct transcatheter aortic valve implantation (TAVI) by the transfemoral approach without balloon pre-dilatation using the Edwards SapienXT valve. TAVI is established in selected high-risk patients with severe aortic stenosis. Balloon aortic valvuloplasty (BAV) is recommended prior to valve implantation, but may contribute to procedural risk. It is unknown whether this is necessary for successful passage and deployment of the device. 81 patients (mean age 84 [95%CI:82-85.8], 62% male, median EuroScore 22.8% [95%CI:20.5-27]) undergoing transfemoral TAVI (35 by direct implantation [direct group]; 46 with balloon pre-dilatation [balloon group]) between 2010 and 2013 were analyzed for efficacy and safety endpoints. Procedural success was 100%. Pre and post-procedural peak gradients in the direct group were 66mmHg (95%CI:59-72.8) and 14mmHg (95%CI:12-17.8)(P < 0.0001) compared to 76.5mmHg (95%CI:73.7-94.0) and 17mmHg (95%CI:16-19)(P < 0.0001) in the balloon group. Post-dilatation was performed in 4/35(11.4%) of the direct group and 3/46(6.5%) of the balloon group (P = 0.83). Post procedure moderate AR was present in 1/35(2.9%) in the direct group and none in the balloon group. In-hospital mortality (2.9% direct vs. 0% balloon group), stroke (2.9% vs. 4.4%), tamponade (2.9% vs. 2.2%), major vascular complications (2.9% vs. 8.7%) and new permanent pacing (2.2% vs. 0) were similar. Pacing time, inflations, radiation dose and contrast use were all significantly lower in the direct group. Direct implantation of the Edwards SapienXT valve during TAVI by the transfemoral route appears safe, efficacious and feasible in those without extreme calcification. © 2016 Wiley Periodicals, Inc.

One-year outcomes after direct transcatheter aortic valve implantation with a self-expanding bioprosthesis. A two-center international experience.

BackgroundBalloon aortic valvuloplasty (BAV) is considered to be an essential part of the transcatheter aortic valve implantation (TAVI) procedure and is being performed routinely. At present there is insufficient long-term data as to the benefits of routine BAV prior to TAVI. AimThe aim of this study was to evaluate the safety of direct TAVI and the mortality rate at 1-year in patients undergoing TAVI with or without BAV with a self-expanding bioprosthesis. MethodsBetween January 2008 and September 2013 consecutive patients undergoing TAVI with the Medtronic CoreValve in two experienced centers in Athens, Greece and in Siegburg, Germany were studied. All data were prospectively collected and retrospectively analyzed. Primary endpoint was mortality at 1year. Procedural data and clinical data (bleeding, vascular complications and echocardiographic parameters) were analyzed. ResultsA total of 210 patients undergoing TAVI were evaluated (non-direct=120 patients, direct=90 patients). All-cause mortality at 30days and at 1year was similar in both groups (4% in non-direct versus 2% in direct, p=0.6 and 15% in non-direct versus 11% in direct, p=0.5, respectively). Device success rate was similar in both groups (77% in non-direct versus 83% in direct, p=0.2). Major vascular complications were comparable for both groups (5% in non-direct versus 3% in direct, p=0.5). The direct group had less moderate/severe paravalvular leakage than the non-direct group after the device implantation (7% versus 33%, p<0.01). ConclusionsPerforming direct TAVI with the self-expanding bioprosthesis is safe and feasible showing similar mortality rates compared to patients undergoing non-direct TAVI at 30days and at 1-year.

Direct Aortic Transcatheter Aortic Valve Implantation: Anaesthesia Attentions

Surgical replacement of aortic valve is the gold standard therapy for severe aortic valve stenosis. Transcatheter Aortic Valve Implantation (TAVI) is less invasive and becomes an alternative therapy reserved for patients with high operative risk. TAVI can be performed via transfemoral, transapical or transaortic approach. Patients with diseased or difficult femoral/iliac vascular access, poor left ventricular function and significant respiratory disease are not suitable for transfemoral or transapical approach. In this scenario, direct transaortic approach of TAVI is a feasible option. This case report presents a case of a 76-year-old man with symptomatic severe aortic valve stenosis who underwent general anaesthesia and was successfully treated by direct transaortic TAVI using Edwards Sapien XT aortic bioprosthesis.

Direct transaortic transcatheter aortic valve implantation

Transcatheter aortic valve implantation (TAVI), has emerged as a new treatment option in patients with severe aortic stenosis who are considered to be high-risk for conventional surgery. In recent years, TAVI has been widely used in Turkey as in all the world. Transaortic approach for TAVI is a new approach in patients with poor peripheral vessels. In this article, we report a 82-year-old female case with severe aortic stenosis and coronary artery disease presenting with several comorbidities who was treated with direct transaortic TAVI and off-pump coronary artery bypass grafting for the first time in Turkey.

Direct transcatheter aortic valve implantation - one-year outcome of a case control study.

IntroductionTransaortic valve implantation (TAVI) has a well-established position in the treatment of high-risk and inoperable patients with severe aortic stenosis (AS). The TAVI protocol requires a pre-dilatation for native valve preparation.AimTo assess the safety and feasibility of TAVI without pre-dilatation and to compare it with the procedure with pre-dilatation.Material and methodsOut of 101 TAVI patients, in 10 the procedure was performed without balloon predilatation, and 8 patients were included in the analysis. The procedural, echocardiographic, and clinical outcomes were compared with a case control matched cohort (1: 2 ratio). A 12-month follow-up was done in all cases.ResultsThe procedure was successfully completed in all patients in the study group (SG), but there was one procedural failure in the control group (CG). All patients received a CoreValve (Medtronic) bioprosthesis. There was a significant immediate decrease in transvalvular gradients (TG) in both study arms after the procedure (SG: mean TG: from 46.0 ±14.0 mm Hg to 10.0 ±4.8 mm Hg, p < 0.001; CG: mean TG: from 55.9 ±12.0 mm Hg to 9.9 ±2.9 mm Hg, p < 0.001). A marked increase in the effective orifice areas was observed in both cohorts (SG: 1.63 ±0.13 cm2 and CG: 1.67 ±0.25 cm2, p = 0.75). The periprocedural complication rate was equally distributed in both arms. The 12-month all-cause mortality was 12.5% in both groups.ConclusionsThe direct TAVI approach seams to be safe and feasible. The clinical and echocardiographic results are not different from those achieved in patients treated with standard TAVI protocol with pre-dilatation.

Cognitive Trajectory After Transcatheter Aortic Valve Implantation

Transcatheter aortic valve implantation (TAVI) is known to be associated with silent cerebral injury, which could contribute to cognitive impairment. Considering its increasing use, thorough longitudinal investigation of cognitive trajectory after TAVI is pivotal. Repeatable battery for the assessment of neuropsychological status was performed before (E1), 3 days (E2), 3 months (E3), 1 (E4) year, and 2 years (E5) after TAVI. Baseline characteristics, procedural data, imaging parameters of brain injury (diffusion-weighted MRI), and the use of conceivable neuroprotective approaches were investigated for their effect on cognitive function. Cognitive performance was investigated in 111 patients (mean log EuroSCORE, 30±13%). Global cognitive function (repeatable battery for the assessment of neuropsychological status total score) increased transiently at E2 (P=0.02) and was comparable with baseline levels at E3, E4, and E5. Six patients (5.4%) demonstrated early cognitive decline. Persistence and late onset were seen infrequently (n=3, 2.7% and n=4, 3.6%, respectively). Hence, early cognitive decline was ruled out in 105 patients (94.6%), and a majority of patients (91%) demonstrated sustained cognitive performance throughout all investigated time points. Interestingly, only patient age (P=0.012), but not prior cerebrovascular events, cognitive status, direct TAVI, cerebral embolism in diffusion-weighted MRI, or the use of a cerebral embolic protection device was found to be independently associated with cognitive decline, linking higher age to cognitive impairment along the first 2 years after TAVI. Long-term cognitive performance was preserved in the great majority (91%) of patients throughout the first 2 years after TAVI, despite the high intrinsic risk for cognitive deterioration. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00883285.