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Background Cerebral microemboliazations remain a major concern peri-operatively and following Transcatheter Aortic Valve Implantation (TAVI). We evaluated whether atrial fibrillation may predispose to an increased number of cerebrovascular emboli during the procedure. Purpose The aim of the study was to evaluate, using a transcranial doppler, the effect of atrial fibrillation on transient high-intensity signals to middle cerebral arteries during transcatheter aortic valve implantation. Methods Consecutive patients who underwent transfemoral TAVI with Evolut™ R bioprosthesis, were categorized into two groups. Group A patients with permanent atrial fibrillation (AF) on anticoagulation, Group B patients with sinus rhythm (SR). Dual antiplatelet therapy with aspirin and clopidogrel was administered to all patients 24 hours prior to the procedure at loading dose, with patients in Group A receiving in addition low-molecular-weight-heparin. The number of detected High Intensity Transient Signals (HITS) was assessed using Rimed Digi-Lite™ Transcranial Doppler on both cerebral arteries during the following phases of the procedure; Phase 0: 30 minutes prior to procedure initiation, Phase I: between access site puncture and introduction of the delivery system, Phase II: during the implantation of the bioprosthesis, until the removal of the delivery system. All implantations were performed without predilation. Furthermore, patients were evaluated by neurologist before TAVI and on discharge day. Safety was evaluated according to VARC-2 criteria. Results Twenty-eight patients were evaluated (81±6 years, 16 males (57.1%)). Group A had higher number of total (786±95 vs. 604±103, p=0.002) as well as Phase I HITS (393±94 vs. 285±86, p=0.002). One cerebrovascular event was recorded in Group A and one patient categorized to Group B developed major bleeding due to conversion to femoral surgical cut-down. The average number of received blood units, was higher in AF compared to SR Group (Group 1: 0.8±1.9 vs. Group 2: 0.5±0.7, p: 0.886), without however, reaching statistical significance. Conclusion Patients with atrial fibrillation had larger burden of embolic HITS during TAVI indicating high risk patients for embolic cerebrovascular events. This may has implications for future strategies for cerebral embolic protection. Funding Acknowledgement Type of funding sources: Public hospital(s). Main funding source(s): Ippokrateio General Hospital of Athens

Objectives The aim of this study was to compare the implantation of a self-expanding valve with or without balloon aortic valvuloplasty (BAV) in an open-label, noninferiority, randomized trial. Background There are no randomized studies comparing the implantation of a self-expanding valve with (pre-BAV) or without BAV. Methods Consecutive patients with severe aortic stenosis were randomly assigned to undergo transcatheter aortic valve replacement with the use of self-expanding prostheses with (pre-BAV) or without (no-BAV) pre-dilatation. The primary endpoint was device success according to the Valve Academic Research Consortium 2 criteria. Secondary endpoints included periprocedural mortality and stroke, new permanent pacemaker implantation, vascular complications, and 1-year mortality. The trial was scheduled to show noninferiority (Δ = 15%) of the direct versus the pre-BAV approach. Results A total of 171 patients were randomized at 4 centers. Of these, 86 underwent transcatheter aortic valve replacement with pre-dilatation and 85 without. Device success was noninferior in the no-BAV group compared with the pre-BAV group (65 of 85 [76.5%] for no-BAV vs. 64 of 86 [74.4%] for pre-BAV; mean difference 2.1%; 90% confidence interval: −8.9% to 13%). In the no-BAV group, 25 patients (29.4%) underwent post-balloon dilatation, and in the pre-BAV group, 13 patients (15.1%) underwent post-balloon dilatation (p = 0.03). Regarding major vascular complications and permanent pacemaker implantation, there was no difference between the 2 groups (log-rank p = 0.49, log-rank p = 0.54). In 1-month completed follow-up for all patients, there was 1 periprocedural stroke (0.5%), without any deaths. Conclusions Direct, without balloon pre-dilatation, transcatheter aortic valve replacement with a self-expanding prosthesis system is noninferior to the pre-dilatation procedure. Lower post-dilatation rates were encountered in the group with pre-dilatation. (The Predilatation in Transcatheter Aortic Valve Implantation Trial [DIRECT]; NCT02448927)

The impact of the antiplatelet regimen and the extent of associated platelet inhibition on cerebrovascular microembolic events during transcatheter aortic valve implantation (TAVI) are unknown. Our aim was to evaluate the effects of ticagrelor versus clopidogrel and of platelet inhibition on the number of cerebrovascular microembolic events in patients undergoing TAVI. Patients scheduled for TAVI were randomized previous to the procedure to either aspirin and ticagrelor or to aspirin and clopidogrel. Platelet inhibition was expressed in P2Y12 reaction units (PRU) and percentage of inhibition. High intensity transient signals (HITS) were assessed with transcranial Doppler (TCD). Safety outcomes were recorded according to the VARC-2 definitions. Among 90 patients randomized, 6 had an inadequate TCD signal. The total number of procedural HITS was lower in the ticagrelor group (416.5 [324.8, 484.2]) (42 patients) than in the clopidogrel group (723.5 [471.5, 875.0]) (42 patients), p0.001. After adjusting for the duration of the procedure, diabetes, extra-cardiac arteriopathy, BMI, hypertension, aortic valve calcium content, procedural ACT, and pre-implantation balloon valvuloplasty, patients on ticagrelor had on average 256.8 (95% CI: [-335.7, -176.5]) fewer total procedural HITS than patients on clopidogrel. Platelet inhibition was greater with ticagrelor 26 [10, 74.5] PRU than with clopidogrel 207.5 (120 to 236.2) PRU, p0.001, and correlated significantly with procedural HITS (r = 0.5, p0.05). In conclusion, ticagrelor resulted in fewer procedural HITS, compared with clopidogrel, in patients undergoing TAVI, while achieving greater platelet inhibition.

ObjectivesTo evaluate the effects of ticagrelor versus clopidogrel and of platelet inhibition on the number of cerebrovascular microembolic events, in patients undergoing transcatheter aortic valve replacement (TAVR).BackgroundThe impact of the antiplatelet regimen and the extent of associated platelet inhibition on cerebrovascular microembolic events during TAVR are unknown.MethodsPatients scheduled for TAVR were randomized prior to the procedure to either aspirin and ticagrelor or to aspirin and clopidogrel. Platelet inhibition was expressed in P2Y12 Reaction Units (PRU) and percentage of inhibition. High intensity transient signals (HITS) were assessed with transcranial Doppler (TCD). Safety outcomes were recorded according to the VARC-2 definitions.ResultsAmong 90 patients randomized, six had inadequate TCD signal. The total number of procedural HITS was lower in the ticagrelor group (416.5 [324.8, 484.2]) (42 patients) than in the clopidogrel group (723.5 [471.5, 875.0]) (42 patients), p< 0.001. After adjusting for the duration of the procedure, diabetes, extra-cardiac arteriopathy, BMI, and aortic valve calcium content, patients on ticagrelor had on average 255.9 (95% CI: [-335.4, -176.4]) fewer total procedural HITS, than did patients on clopidogrel. Platelet inhibition was greater in those randomized to ticagrelor 26 [10, 74.5] PRU than in those randomized to clopidogrel 207.5 [120-236.2] PRU, pConclusionsTicagrelor resulted in fewer procedural HITS, compared to clopidogrel, in patients undergoing TAVR, while achieving greater platelet inhibition, without increasing the risk for complications.Clinical Trial(ClinicalTrials.gov Identifier: NCT02989558)CONDENSED ABSTRACTWe conducted a two-center, prospective, open label, randomized, controlled clinical trial to compare the efficacy of ticagrelor vs clopidogrel in preventing cerebrovascular embolic events as assessed by transcranial Doppler during TAVR.The total number of procedural HITS was lower in the ticagrelor group (416.5 [324.8, 484.2]) than in the clopidogrel group (723.5 [471.5, 875.0]), p< 0.001. Patients on ticagrelor had on average 255.9 (95% CI: [-335.4, -176.4]) fewer total procedural HITS than those on clopidogrel. This protective effect was not associated with an increase in complications.

Introduction The DIRECT trial (Predilatation in Transcatheter Aortic Valve Implantation Trial) evaluated in a randomized fashion the safety and efficacy of direct (without balloon pre-dilatation) implantation of a self-expanding valve in all comers undergoing TAVI. Purpose To investigate the impact of direct implantation of a self-expanding valve on one-year clinical outcomes. Methods DIRECT trial randomized consecutive patients with severe aortic stenosis at 4 tertiary centers to undergo TAVI with the use of self-expanding prostheses with (pre-BAV) or without pre-dilatation (no-BAV). The primary endpoint was device success according to the VARC-2 criteria. Secondary endpoints included periprocedural mortality and stroke, new permanent pacemaker implantation and vascular complications. All cause death, cardiac death, stroke and heart failure hospitalizations were recorded at one year and compared between the two groups using Kaplan-Meier plots. Results In total 171 patients were randomized in 4 centers. In the intention to treat analysis 86 patients were randomized to the pre-BAV group and 85 patients to the no-BAV TAVI group. The device success according to the VARC-2 criteria was non-inferior in the no-BAV group compared to the pre-BAV group (65/85 - 76.5% for no-BAV versus 64/86 – 74.4% for pre-BAV, mean difference = 2.1%, 90% CI: −8.9 to 13). In the no-BAV group 25 (29.4%) patients underwent post balloon dilatation and in the pre-BAV group 13 patients (15.1%) (p=0.03). At one year 4 deaths were recorded in pre-BAV group (4.7%) and 3 deaths in no-BAV group (3.5%). There was no difference in Kaplan-Meier plots between the two groups in all-cause mortality (log-rank p=0.72, figure). Similarly, there was no difference in one-year incidence of stroke (1 in pre-BAV and 2 in no-BAV group, log-rank p=0.55), cardiac death (log-rank p=0.66), non-cardiac death (log-rank p=0.98) and heart failure hospitalizations (1 in pre-BAV versus 3 in no-BAV group, log-rank p=0.31). Lastly, there was no difference in the incidence of permanent pacemaker implantation between the two groups at one year (27/67 in no-BAV group versus 20/69 in pre-BAV group, log-rank p=0.24) Conclusions Direct transcatheter aortic valve implantation is non-inferior to the procedure with pre-dilatation in self-expanding valve. Despite the overall low rate of events, direct procedure has no impact on clinical outcomes at one year. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Medtronic

Background Transcatheter aortic valve implantation (TAVI) has seen an unprecedented rise in the past decade and has become the gold-standard therapy for inoperable, high- and intermediate-risk patients with aortic valve stenosis. Purpose To investigate the long-term clinical outcomes (5-year survival and beyond) of patients undergoing TAVI. Methods Consecutive patients who underwent TAVI with a self-expanding valve between 2012 - 2015 were included in the study. Patients with bicuspid valves and valve-in-valve procedures were excluded. Clinical follow-up was performed at specified time intervals (30-day post TAVI and yearly thereafter). The primary endpoint of this study was to evaluate survival rates in the long-term (≥5 years). Secondary endpoints were echocardiographic findings and clinical status at 5 years. All endpoints were considered as per the VARC-2 criteria and the latest consensus documents. Results In total, 267 patients were included in the study. Complete follow-up was complete in 189 (70%) patients. The mean age at implantation was 80.71±6.81 years, 129 (48%) were female, mean logistic EuroSCORE was 24.28±8.64% and 73% of patients were at NYHA Class III. The median follow-up was 4.0±1.5 years. Before the procedure, ejection fraction (EF) was 49.92±9.37%, mean gradient was 48.83±14.68mmHg, pulmonary artery systolic pressure (PASP) was 44.31±12.72mmHg and aortic valve area was 0.98±5.02cm2. All patients received the self-expanding valve (mean valve size was 27.60±2.12mm), with the majority of them undergoing transfemoral TAVI (71%). Predilation was performed in 77% of the population and post TAVI dilation was performed in 20%. Compared to pre TAVI values, EF was higher at 50.66±9.37% (p=0.041), mean gradient was lower at 9.41±4.65mmHg (p At the end of the fifth year, 160 (60%) patients were alive. Mean survival post TAVI was 32 months (median: 32.2 months, range: 0–91.2 months) and the majority of deaths were non-cardiac in nature (78%). Also, 43% patients of patients were at NYHA Class I, 50% were at NYHA Class II and 7% were at NYHA Class III. At multivariate analysis, sole independent predictor of death at 5 years was baseline PASP levels (OR 1.027, 95% CI: 1–1.054, p=0.049). Conclusion Transcatheter aortic valve implantation offers a viable solution for aortic stenosis patients and long-term results beyond 5 years are reassuring. Further studies are necessary in order to shed a light for very long-term outcomes. Funding Acknowledgement Type of funding source: None

Introduction Transcatheter aortic valve implantation (TAVI) has become the standard of care for high-risk and inoperable surgical patients and a valid alternative in intermediate-risk patients with severe aortic stenosis.The DIRECT trial (Predilatation in Transcatheter Aortic Valve Implantation Trial) was a multicenter, randomized, clinical trial designed to evaluate the safety and efficacy of TAVI with or without balloon aortic valvuloplasty (BAV) in patients with symptomatic, severe aortic valve stenosis. Purpose To compare the one year echocardiographic findings among patients, who underwent TAVI using a self-expanding valve with or without BAV. Methods A total of 171 patients with severe aortic stenosis were randomly assigned at 4 tertiary centers to undergo TAVI with the use of self-expanding prostheses with (pre-BAV) or without pre-dilatation (no-BAV). Follow up transthoracic echocardiography was performed 1 year after TAVI. Results Of 171 patients, 86 patients were randomized to pre-BAV group and 85 to no-BAV group. One year echocardiographic follow up was available in 146 patients. In one year follow up there was no significant difference between pre-BAV and no-BAV group in aortic valve area (1.84±0.39cm2 vs. 1.85±0.44cm2, p=0.79), peak aortic valve gradient (15.95±9.97 mmHg vs. 14.51±6.60 mmHg, p=0.35), mean aortic valve gradient (8.37±5.01 mmHg vs. 7.99±4.04 mmHg, p=0.64), aortic valve peak velocity (1.90±0.51 m/s vs. 1.80±0.42m/s, p=0.24), ejection fraction (54.19±8.36% vs. 53.19±9.58%, p=0.52) and pulmonary artery systolic pressure (41.86±14.34 mmHg vs. 40.71±12.40 mmHg, p=0.64). The incidence of moderate or severe paravalvular regurgitation (PVL) in 1 year follow up was 6.2% without significant difference between the 2 study groups (5.7% in the no-BAV group vs. 6.6% in the pre-BAV group, p=0.83). Conclusions Direct transcatheter aortic valve implantation has no impact on one-year prosthesis function and PVL in patients undergoing TAVI with self-expanding valve Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Medtronic

Introduction The DIRECT trial (Predilatation in Transcatheter Aortic Valve Implantation (TAVI) Trial) was a multicenter, randomized, clinical trial designed to evaluate the safety and efficacy of TAVI with or without balloon aortic valvuloplasty (BAV) in patients with symptomatic, severe aortic valve stenosis. Purpose To investigate by echocardiography the functional changes of self-expanding prosthetic valves during the first year after TAVI with or without BAV. Methods One hundred seventy one consecutive patients with severe aortic stenosis were enrolled at 4 centers and randomized to TAVI using self-expanding prostheses with (pre-BAV) or without pre-dilatation (no-BAV). Transthoracic echocardiography was obtained at baseline, 30 days and 1 year after TAVI. Results Of 171 patients, 86 patients were randomized to pre-BAV group and 85 to no-BAV group. Over the one year, 7 (4%) patients died and in 18 (10%) there was no available paired 30 day/1 year echo. At baseline echocardiography the peak and mean aortic valve gradient and the aortic valve area (AVA) in no-BAV group were 77.31±22.56 mmHg, 47.23±14.98 mmHg and 0.69±0.16cm2 and in pre-BAV group 81.97±23.17 mmHg, 49.39±14.78 mmHg and 0.65±0.15cm2 respectively. One year after TAVI, patients in no-BAV and pre-BAV group showed stable peak and mean aortic valve gradients similar to those at 30 days (from 16.36±7.88 to 14.51±6.6 mmHg vs. 17.17±8.88 to 15.95±9.97 mmHg and from 8.87±4.23 to 7.99±4.04 mmHg vs. 9.39±4.79 to 8.38±5.02 mmHg respectively, P Conclusions In both pre-BAV and no-BAV groups the improvement in hemodynamics of self-expanding prosthetic valves remained durable during the one year echocardiographic follow up assessment. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): MEDTRONIC

Background It has been shown that high Residual Platelet Reactivity (RPR) may contribute to platelet aggregation which propagates thrombosis on implanted materials. Therefore, we evaluated whether high RPR may predispose to an increased number of cerebrovascular emboli during Transcatheter Aortic valve Implantation (TAVI). Methods Consecutive patients who underwent transfemoral TAVI with a self-expandable valve were prospectively studied. A loading dose of P2Y12 inhibitor 24 hours preprocedurally was given. Additionally, aspirin was started one week prior to procedure in all patients. Platelet inhibition was assessed with P2Y12 reaction units (PRU) (Verify Now assay) as well as percentage of inhibition 30 minutes prior to procedure initiation. The number of High intensity transient signals (HITS) was assessed with Rimed Digi-Lite™ transcranial Doppler, setting a threshold for detection of HITS at 3dB, continuously, on both middle cerebral arteries during the whole procedure. Two observers reviewed offline the number of HITS. Results In total, 84 patients underwent TAVI (53 males, mean age=81.9yrs old ±8,98). Mean baseline PRU and percentage of platelet inhibition was 258,24±43,03 (156–376) and 48,51%±40.05 (0–100%) respectively. In the treated patients the mean absolute total number of HITS and the number of HITS per minute recorded, was 566,63±272,32, (136–1432) and 6.7/min±3.3 (2.09–13.24) respectively. Significant positive correlation was found between baseline PRU levels and number of total HITS (r=0.261, p=0.017), (Figure 1). Multivariate regression analysis revealed that PRU was independent prognostic factor of total HITS (β=0.708, p=0.06), In order to clarify the predictive role of platelet inhibition in the total number of recorded HITS a ROC analysis was performed, obtaining an area under the curve of 0.646 (95% CI 0.518 to 0.773, p=0.047). PRU-levels≥169 were shown to predict number of HITS at the upper quartile with 76% sensitivity and 65% specificity. Conclusion High RPR after dual antiplatelet loading with a P2Y12 inhibitor and aspirin, resulted in larger burden of embolic HITS during TAVI procedure. A cut off point of 169 PRU units with 76% sensitivity and 65% specificity predicted detection of HITS at the higher quartile. PRU-HITS Correlation Funding Acknowledgement Type of funding source: None

The aim of this study was to compare the implantation of a self-expanding valve with or without balloon aortic valvuloplasty (BAV) in an open-label, noninferiority, randomized trial.There are no randomized studies comparing the implantation of a self-expanding valve with (pre-BAV) or without BAV.Consecutive patients with severe aortic stenosis were randomly assigned to undergo transcatheter aortic valve replacement with the use of self-expanding prostheses with (pre-BAV) or without (no-BAV) pre-dilatation. The primary endpoint was device success according to the Valve Academic Research Consortium 2 criteria. Secondary endpoints included periprocedural mortality and stroke, new permanent pacemaker implantation, vascular complications, and 1-year mortality. The trial was scheduled to show noninferiority (Δ = 15%) of the direct versus the pre-BAV approach.A total of 171 patients were randomized at 4 centers. Of these, 86 underwent transcatheter aortic valve replacement with pre-dilatation and 85 without. Device success was noninferior in the no-BAV group compared with the pre-BAV group (65 of 85 [76.5%] for no-BAV vs. 64 of 86 [74.4%] for pre-BAV; mean difference 2.1%; 90% confidence interval: -8.9% to 13%). In the no-BAV group, 25 patients (29.4%) underwent post-balloon dilatation, and in the pre-BAV group, 13 patients (15.1%) underwent post-balloon dilatation (p = 0.03). Regarding major vascular complications and permanent pacemaker implantation, there was no difference between the 2 groups (log-rank p = 0.49, log-rank p = 0.54). In 1-month completed follow-up for all patients, there was 1 periprocedural stroke (0.5%), without any deaths.Direct, without balloon pre-dilatation, transcatheter aortic valve replacement with a self-expanding prosthesis system is noninferior to the pre-dilatation procedure. Lower post-dilatation rates were encountered in the group with pre-dilatation. (The Predilatation in Transcatheter Aortic Valve Implantation Trial [DIRECT]; NCT02448927).

BACKGROUND: Inflammation plays an important role in the initiation and progression of acute aortic dissection (AAD). New inflammatory indices derived from full cell blood count and its differential may be associated with increased risk. We evaluated platelet‐lymphocyte (PLR), red cell distribution width (RDW) and RDW/PLT's (platelets) (RPR) in AAD. METHODS: We studied 120 consecutive patients with AAD type I admitted for emergency surgery (group I), 121 consecutive patients with aortic aneurysms of the ascending aorta prior to elective repair (group II) and 121 controls (group III), age and sex matched. RESULTS: PLR was significantly higher in group I vs both groups II and III (P

Whether non-thienopyridines may protect patients more efficiently from microembolic events during TAVI has not been investigated. We hypothesized that ticagrelor+ASA will reduce the number of microemboli towards the cerebral circulation during TAVI comparing to the combination of clopidogrel+ASA.