Safety and feasibility of early discharge after transcatheter aortic valve implantation with ACURATE Neo-the POLESTAR trial.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) serves a growing range of patients with severe aortic stenosis (AS). TAVI has evolved to a streamlined procedure minimizing length of hospital stay. AIMS: To evaluate the safety and efficacy of an early discharge (ED) strategy after TAVI. METHODS: We performed an international, multi-center, prospective observational single-arm study in AS patients undergoing TAVI with the ACURATE valve platform. Eligibility for ED was assessed prior to TAVI and based on prespecified selection criteria. Discharge ≤ 48 h was defined as ED. Primary Valve Academic Research Consortium (VARC)-3-defined 30-day safety and efficacy composite endpoints were landmarked at 48 h and compared between ED and non-ED groups. RESULTS: A total of 252 patients were included. The median age was 82 [25th-75th percentile, 78-85] years and the median Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) score was 2.2% [25th-75th percentile, 1.6-3.3]. ED and non-ED were achieved in 173 (69%) and 79 (31%) patients respectively. Monitoring for conduction disturbances was the principal reason for non-ED (33%). Overall, at 30 days, all-cause mortality was 1%, new permanent pacemaker rate was 4%, and valve- or procedure-related rehospitalization was 4%. There was no difference in the primary safety and efficacy endpoint between the ED and non-ED cohorts (OR 0.84 [25th-75th percentile, 0.31-2.26], p = 0.73, and OR 0.97 [25th-75th percentile, 0.46-2.06], p = 0.94). The need for rehospitalization was similarly low for ED and non-ED groups. CONCLUSION: Early discharge after TAVI with the ACURATE valve is safe and feasible in selected patients. Rhythm monitoring and extended clinical observation protracted hospital stay.

Transcatheter aortic valve implantation versus surgical aortic valve replacement in severe aortic stenosis patients at low surgical mortality risk: a cost-effectiveness analysis in Belgium.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) with the SAPIEN 3 device has recently shown significant clinical benefits, compared to surgical aortic valve replacement (SAVR), in patients at low risk for surgical mortality (PARTNER 3 trial, NCT02675114). Currently in Belgium, TAVI use is restricted to high-risk or inoperable patients with severe symptomatic aortic stenosis (sSAS). This cost-utility analysis aimed to assess whether TAVI with SAPIEN 3 could lead to potential cost-savings compared with SAVR, in the low-risk sSAS population in Belgium. METHODS: A previously published, two-stage, Markov-based cost-utility model was used. Clinical outcomes were captured using data from PARTNER 3 and the model was adapted for the Belgian context using cost data from the perspective of the Belgian National Healthcare System, indexed to 2022. A lifetime horizon was chosen. The model outputs included changes in direct healthcare costs, survival and health-related quality of life using TAVI versus SAVR. RESULTS: TAVI with SAPIEN 3 provides meaningful clinical and cost benefits over SAVR, in terms of an increase in quality-adjusted life years (QALYs) of 0.94 and cost-saving of €3 013 per patient. While initial procedure costs were higher for TAVI compared with SAVR, costs related to rehabilitation, disabling stroke, treated atrial fibrillation, and rehospitalization were lower. The cost-effectiveness of TAVI over SAVR remained robust in sensitivity analyses. CONCLUSION: TAVI with SAPIEN 3 may offer a meaningful alternative intervention to SAVR in Belgian low-risk patients with sSAS, showing both clinical benefits and cost savings associated with post-procedure patient management.

Bleeding and thrombotic risk of different antiplatelet regimens posttranscatheter edge-to-edge mitral valve repair in patients with an indication for oral anticoagulation: Results from an all-comers national registry.

BACKGROUND: Evidence-based recommendations for antithrombotic treatment in patients who have an indication for oral anticoagulation (OAC) after transcatheter edge-to-edge mitral valve repair (TEER) are lacking. AIMS: To compare bleeding and thrombotic risk for different antithrombotic regimens post-TEER with MitraClip in an unselected population with the need for OACs. METHODS: Bleeding and thrombotic complications (stroke and myocardial infarction) up to 3 months after TEER with mitraclip were evaluated in 322 consecutive pts with an indication for OACs. These endpoints were defined by the Mitral Valve Academic Research Consortium criteria and were compared between two antithrombotic regimens: single antithrombotic therapy with OAC (single ATT) and double/triple ATT with a combination of OAC and aspirin and/or clopidogrel (combined ATT). RESULTS: Collectively, 108 (34%) patients received single ATT, 203 (63%) received double ATT and 11 (3%) received triple ATT. Bleeding events occurred in 67 patients (20.9%), with access site related events being the most frequent cause (37%). Bleeding complications were observed more frequently in the combined ATT group than in the single ATT group: 24% versus 14% [p = 0.03, adjusted RR: 0.55 (0.3-0.98)]. Within the combined group, the bleeding risk was 23% in the double ATT and 45% in the triple ATT group. Thrombotic complications occurred in only three patients (0.9%), and all belonged to the combined ATT group. CONCLUSIONS: In patients with an indication for OACs, withholding of antiplatelet therapy post-TEER with Mitraclip was associated with a 45% reduction in bleeding and without a signal of increased thrombotic risk.

Periprocedural continuation versus interruption of oral anticoagulant drugs during transcatheter aortic valve implantation: rationale and design of the POPular PAUSE TAVI trial.

About one-third of patients undergoing transcatheter aortic valve implantation (TAVI) use oral anticoagulants (OAC), mainly due to atrial fibrillation. General guidelines advise interrupting OAC in patients with a high risk of bleeding undergoing interventions. However, preliminary observational data suggest that the continuation of OAC during TAVI is safe and may reduce the risk of periprocedural thromboembolic events. The Periprocedural Continuation Versus Interruption of Oral Anticoagulant Drugs During Transcatheter Aortic Valve Implantation (POPular PAUSE TAVI) is a multicentre, randomised clinical trial with open-label treatment and blinded endpoint assessment. Patients are randomised 1:1 to periprocedural continuation versus interruption of OAC and are stratified for vitamin K antagonist or direct oral anticoagulant use. The primary endpoint is a composite of cardiovascular mortality, all stroke, myocardial infarction, major vascular complications and type 2-4 bleeding within 30 days after TAVI, according to the Valve Academic Research Consortium-3 criteria. Secondary endpoints include separate individual and composite outcomes, quality of life and cost-effectiveness. Since continuation of OAC is associated with the ancillary benefit that it simplifies periprocedural management, the primary outcome is first analysed for non-inferiority; if non-inferiority is proven, superiority will be tested. Recruitment started in November 2020, and the trial will continue until a total of 858 patients have been included and followed for 90 days. In summary, POPular PAUSE TAVI is the first randomised clinical trial to assess the safety and efficacy of periprocedural continuation versus interruption of OAC in patients undergoing TAVI.

Incidence, Predictors, and Prognostic Impact of New Permanent Pacemaker Implantation After TAVR With Self-Expanding Valves.

OBJECTIVES: The authors sought to evaluate the incidence, predictors, and outcomes of new permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement (TAVR) with contemporary self-expanding valves (SEV). BACKGROUND: Need for PPI is frequent post-TAVR, but conflicting data exist on new-generation SEV and on the prognostic impact of PPI. METHODS: This study included 3,211 patients enrolled in the multicenter NEOPRO (A Multicenter Comparison of Acurate NEO Versus Evolut PRO Transcatheter Heart Valves) and NEOPRO-2 (A Multicenter Comparison of ACURATE NEO2 Versus Evolut PRO/PRO+ Transcatheter Heart Valves 2) registries (January 2012 to December 2021) who underwent transfemoral TAVR with SEV. Implanted transcatheter heart valves (THV) were Acurate neo (n = 1,090), Acurate neo2 (n = 665), Evolut PRO (n = 1,312), and Evolut PRO+ (n = 144). Incidence and predictors of new PPI and 1-year outcomes were evaluated. RESULTS: New PPI was needed in 362 patients (11.3%) within 30 days after TAVR (8.8%, 7.7%, 15.2%, and 10.4%, respectively, after Acurate neo, Acurate neo2, Evolut PRO, and Evolut PRO+). Independent predictors of new PPI were Society of Thoracic Surgeons Predicted Risk of Mortality score, baseline right bundle branch block and depth of THV implantation, both in patients treated with Acurate neo/neo2 and in those treated with Evolut PRO/PRO+. Predischarge reduction in ejection fraction (EF) was more frequent in patients requiring PPI (P = 0.014). New PPI was associated with higher 1-year mortality (16.9% vs 10.8%; adjusted HR: 1.66; 95% CI: 1.13-2.43; P = 0.010), particularly in patients with baseline EF <40% (P for interaction = 0.049). CONCLUSIONS: New PPI was frequently needed after TAVR with SEV (11.3%) and was associated with higher 1-year mortality, particularly in patients with EF <40%. Baseline right bundle branch block and depth of THV implantation independently predicted the need of PPI.

Incidence, predictors, and prognostic impact of new permanent pacemaker implantation after TAVR with self-expanding valves

OBJECTIVES: The authors sought to evaluate the incidence, predictors, and outcomes of new permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement (TAVR) with contemporary self-expanding valves (SEV). BACKGROUND: Need for PPI is frequent post-TAVR, but conflicting data exist on new-generation SEV and on the prognostic impact of PPI. METHODS: This study included 3,211 patients enrolled in the multicenter NEOPRO (A Multicenter Comparison of Acurate NEO Versus Evolut PRO Transcatheter Heart Valves) and NEOPRO-2 (A Multicenter Comparison of ACURATE NEO2 Versus Evolut PRO/PRO+ Transcatheter Heart Valves 2) registries (January 2012 to December 2021) who underwent transfemoral TAVR with SEV. Implanted transcatheter heart valves (THV) were Acurate neo (n = 1,090), Acurate neo2 (n = 665), Evolut PRO (n = 1,312), and Evolut PRO+ (n = 144). Incidence and predictors of new PPI and 1-year outcomes were evaluated. RESULTS: New PPI was needed in 362 patients (11.3%) within 30 days after TAVR (8.8%, 7.7%, 15.2%, and 10.4%, respectively, after Acurate neo, Acurate neo2, Evolut PRO, and Evolut PRO+). Independent predictors of new PPI were Society of Thoracic Surgeons Predicted Risk of Mortality score, baseline right bundle branch block and depth of THV implantation, both in patients treated with Acurate neo/neo2 and in those treated with Evolut PRO/PRO+. Predischarge reduction in ejection fraction (EF) was more frequent in patients requiring PPI (P = 0.014). New PPI was associated with higher 1-year mortality (16.9% vs 10.8%; adjusted HR: 1.66; 95% CI: 1.13-2.43; P = 0.010), particularly in patients with baseline EF <40% (P for interaction = 0.049). CONCLUSIONS: New PPI was frequently needed after TAVR with SEV (11.3%) and was associated with higher 1-year mortality, particularly in patients with EF <40%. Baseline right bundle branch block and depth of THV implantation independently predicted the need of PPI.

Titanium-Nitride-Oxide-Coated vs Everolimus-Eluting Stents in Acute Coronary Syndrome: 5-Year Clinical Outcomes of the TIDES-ACS Randomized Clinical Trial.

Importance: Titanium-nitride-oxide (TiNO)-coated stents show faster strut coverage compared with drug-eluting stents without excessive intimal-hyperplasia observed in bare metal stents. It is important to study long-term clinical outcomes after treatment of patients with an acute coronary syndrome (ACS) by TiNO-coated stents, which are neither drug-eluting stents nor bare metal stents. Objective: To compare the rate of main composite outcome of cardiac death, myocardial infarction (MI), or ischemia-driven target lesion revascularization at 5 years in patients with ACS randomized to receive either a TiNO-coated stent or a third-generation everolimus-eluting stent (EES). Design, Setting, and Participants: This multicenter, randomized, controlled, open-label trial was conducted in 12 clinical sites in 5 European countries and enrolled patients from January 2014 to August 2016. Patients presenting with ACS (ST-segment elevation MI, non-ST-segment elevation MI, and unstable angina) with at least 1 de novo lesion were randomized to receive either a TiNO-coated stent or an EES. The present report analyzes the long-term follow-up for the main composite outcome and its individual components. Analysis took place between November 2022 to March 2023. Main outcome: The primary end point was a composite of cardiac death, MI, or target lesion revascularization at 12-month follow-up. Results: A total of 1491 patients with ACS were randomly assigned to receive either TiNO-coated stents (989 [66.3%]) or EES (502 [33.7%]). The mean (SD) age was 62.7 (10.8) years, and 363 (24.3%) were female. At 5 years, the main composite outcome events occurred in 111 patients (11.2%) in the TiNO group vs 60 patients (12%) in the EES group (hazard ratio [HR], 0.94; 95% CI, 0.69-1.28; P = .69). The rate of cardiac death was 0.9% (9 of 989) vs 3.0% (15 of 502) (HR, 0.30; 95% CI, 0.13-0.69; P = .005), the rate of MI was 4.6% (45 of 989) vs 7.0% (35 of 502) (HR, 0.64; 95% CI, 0.41-0.99; P = .049), the rate of stent thrombosis was 1.2% (12 of 989) vs 2.8% (14 of 502) (HR, 0.43; 95% CI, 0.20-0.93; P = .034), and the rate of target lesion revascularization was 7.4% (73 of 989) vs 6.4% (32 of 502) (HR, 1.16; 95% CI, 0.77-1.76; P = .47) in the TiNO-coated stent arm and in the EES arm, respectively. Conclusion and relevance: In this study, patients with ACS had a main composite outcome that was not different 5 years after TiNO-coated stent or EES. Trial Registration: ClinicalTrials.gov Identifier: NCT02049229.

Temporal Trends and Contemporary Outcomes After Transcatheter Aortic Valve Replacement With Evolut PRO/PRO+ Self-Expanding Valves: Insights From the NEOPRO/NEOPRO-2 Registries.

BACKGROUND: In recent years, transcatheter aortic valve replacement (TAVR) techniques and technology have continuously improved. Data regarding the impact of these advancements on outcomes in large real-world settings are still limited. The aim of this study was to investigate temporal trends and assess contemporary outcomes after TAVR with Evolut PRO/PRO+ supra-annular self-expanding valves. METHODS: This study included patients enrolled in the multicenter NEOPRO (A Multicenter Comparison of Acurate NEO Versus Evolut PRO Transcatheter Heart Valves) and NEOPRO-2 (A Multicenter Comparison of ACURATE NEO2 Versus Evolut PRO/PRO+ Transcatheter Heart Valves 2) registries who underwent transfemoral TAVR with Evolut PRO/PRO+. Procedural dates (August 2017 through November 2021) were stratified in quartiles (Q) and used to investigate temporal trends in TAVR outcomes. Predischarge, 30-day Valve Academic Research Consortium-3 defined, and 1-year outcomes were evaluated. RESULTS: In total, 1616 patients from 28 centers were included. Over time, patients had lower Society of Thoracic Surgeon-Predicted Risk of Mortality score (Q1-4, 4.1% [2.8-6.3%], 3.7% [2.6-5.3%], 3.3% [2.4-4.9%], 2.9% [2.2-4.3%]; P<0.001) and more moderate or heavy valve calcification (Q1-4, 80%, 80%, 82%, 88%; P=0.038). Overall Valve Academic Research Consortium-3 technical success was 94.1%, with 30-day and 1-year all-cause mortality of 2.4% and 10%, respectively. Throughout the study period, procedures were associated with higher rates of 30-day device success (Q1-4, 81.2%, 82.2%, 82.0%, 88.0%; Cochran-Armitage P=0.023) and early safety (Q1-4, 66.8%, 67.5%, 74.0%, 77.6%; Cochran-Armitage P<0.001), with fewer permanent pacemaker implantations (Q1-4: 15.3%, 20.0%, 12.1%, 11.6%; Cochran-Armitage P=0.023) and residual mild or greater paravalvular leaks (Q1-4, 50.4%, 42.1%, 36.5%, 35.8%; Cochran-Armitage P<0.001). CONCLUSIONS: TAVR with Evolut PRO/PRO+ self-expanding valve is safe and effective. Despite the treatment of heavier calcified anatomies, procedural outcomes are improving over time with less need for pacemaker implantation and less significant paravalvular leaks.

Comparison of transcatheter aortic valve replacement with the ACURATE neo2 versus Evolut PRO/PRO+ devices.

BACKGROUND: The ACURATE neo2 (NEO2) and Evolut PRO/PRO+ (PRO) bioprostheses are new-generation self-expanding valves developed for transcatheter aortic valve replacement (TAVR). AIMS: We sought to compare the performance of the ACURATE neo2 and Evolut PRO/PRO+ devices. METHODS: The NEOPRO-2 registry retrospectively included patients who underwent TAVR for severe aortic stenosis with either the NEO2 or PRO devices between August 2017 and December 2021 at 20 centres. In-hospital and 30-day Valve Academic Research Consortium (VARC)-3 defined outcomes were evaluated. Propensity score (PS) matching and binary logistic regression were performed to adjust the treatment effect for PS quintiles. A subgroup analysis assessed the impact of aortic valve calcification. RESULTS: A total of 2,175 patients (NEO2: n=763; PRO: n=1,412) were included. The mean age was 82±6.2 years and the mean Society of Thoracic Surgeons score was 4.2%. Periprocedural complications were low, and both groups achieved high rates of technical success (93.1% vs 94.1%; p=0.361) and predischarge intended valve performance (96.0% vs 94.1%; p=0.056), both in the unmatched and matched analysis (452 pairs). Device success at 30 days was comparable (84.3% vs 83.6%; p=0.688), regardless of aortic valve calcification severity (p>0.05 for interaction). A suggestion for higher VARC-3 early safety in the NEO2 group was mainly driven by reduced rates of new permanent pacemaker implantation (7.7% vs 15.6%; p<0.001). CONCLUSIONS: This retrospective analysis reports a similar short-term performance of the ACURATE neo2 platform compared with the new-generation Evolut PRO/PRO+ devices. Randomised studies are needed to confirm our exploratory findings.

Haemodynamic performance and clinical outcomes of transcatheter aortic valve replacement with the self-expanding ACURATE neo2.

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

Rationale and Design of the Project to Look for Early Discharge in Patients Undergoing TAVR With ACURATE (POLESTAR Trial).

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is now an established treatment strategy for elderly patients with symptomatic aortic stenosis (AS) across the entire operative risk spectrum. Streamlined TAVR protocols along with reduced procedure time and expedited ambulation promote early hospital discharge. Selection of patients suitable for safe early discharge after TAVR might improve healthcare efficiency. STUDY DESIGN: The POLESTAR trial is an international, multi-center, prospective, observational study which aims to evaluate the safety of early discharge in selected patients who undergo TAVR with the supra-annular functioning self-expanding ACURATE Neo transcatheter heart valve (THV). A total of 250 patients will be included based on a set of baseline criteria indicating potential early discharge (within 48 h post-TAVR). Primary study endpoints include Valve Academic Research Consortium (VARC)-3 defined safety at 30 days and VARC-3 defined efficacy at 30 days and 1 year. Endpoints will be compared between early discharge and non-early discharge cohorts with a distinct landmark analysis at 48 h post-TAVR. Secondary endpoints include quality of life assessed using EQ5D-5L and Kansas City Cardiomyopathy Questionnaire (KCCQ) questionnaires and resource costs compared between discharge groups. SUMMARY: The POLESTAR trial prospectively evaluates safety and feasibility of an early discharge protocol for TAVR using the ACURATE Neo THV.

Latent Pulmonary Vascular Disease May Alter the Response to Therapeutic Atrial Shunt Device in Heart Failure.

BACKGROUND: In REDUCE LAP-HF II (A Study to Evaluate the Corvia Medical, Inc IASD System II to Reduce Elevated Left Atrial Pressure in Patients With Heart Failure), implantation of an atrial shunt device did not provide overall clinical benefit for patients with heart failure with preserved or mildly reduced ejection fraction. However, prespecified analyses identified differences in response in subgroups defined by pulmonary artery systolic pressure during submaximal exercise, right atrial volume, and sex. Shunt implantation reduces left atrial pressures but increases pulmonary blood flow, which may be poorly tolerated in patients with pulmonary vascular disease (PVD). On the basis of these results, we hypothesized that patients with latent PVD, defined as elevated pulmonary vascular resistance during exercise, might be harmed by shunt implantation, and conversely that patients without PVD might benefit. METHODS: REDUCE LAP-HF II enrolled 626 patients with heart failure, ejection fraction ≥40%, exercise pulmonary capillary wedge pressure ≥25 mm Hg, and resting pulmonary vascular resistance <3.5 Wood units who were randomized 1:1 to atrial shunt device or sham control. The primary outcome-a hierarchical composite of cardiovascular death, nonfatal ischemic stroke, recurrent HF events, and change in health status-was analyzed using the win ratio. Latent PVD was defined as pulmonary vascular resistance ≥1.74 Wood units (highest tertile) at peak exercise, measured before randomization. RESULTS: Compared with patients without PVD (n=382), those with latent PVD (n=188) were older, had more atrial fibrillation and right heart dysfunction, and were more likely to have elevated left atrial pressure at rest. Shunt treatment was associated with worse outcomes in patients with PVD (win ratio, 0.60 [95% CI, 0.42, 0.86]; P=0.005) and signal of clinical benefit in patients without PVD (win ratio, 1.31 [95% CI, 1.02, 1.68]; P=0.038). Patients with larger right atrial volumes and men had worse outcomes with the device and both groups were more likely to have pacemakers, heart failure with mildly reduced ejection fraction, and increased left atrial volume. For patients without latent PVD or pacemaker (n=313; 50% of randomized patients), shunt treatment resulted in more robust signal of clinical benefit (win ratio, 1.51 [95% CI, 1.14, 2.00]; P=0.004). CONCLUSIONS: In patients with heart failure with preserved or mildly reduced ejection fraction, the presence of latent PVD uncovered by invasive hemodynamic exercise testing identifies patients who may worsen with atrial shunt therapy, whereas those without latent PVD may benefit.

Treatment of Resistant Hypertension With Endovascular Baroreflex Amplification: 3-Year Results From the CALM-FIM Study.

OBJECTIVES: The aim of this study was to evaluate the long-term (3-year) safety and effectiveness of endovascular baroreflex amplification (EVBA) from both the European and American CALM-FIM cohorts. BACKGROUND: The CALM-FIM study demonstrated that EVBA in patients with resistant hypertension significantly lowered blood pressure (BP) with an acceptable safety profile during 6-month follow-up. METHODS: The CALM-FIM studies were prospective, nonrandomized, first-in-human studies that enrolled patients with resistant hypertension (office systolic BP ≥160 mm Hg and mean 24-hour ambulatory BP ≥130/80 mm Hg despite a stable regimen of ≥3 antihypertensive medications, including a diuretic agent). The incidence of (serious) adverse events and changes in BP, heart rate, and prescribed antihypertensive medication up to 3 years after implantation were determined. RESULTS: The Mobius device was implanted in 47 patients (30 in Europe, 17 in the United States; mean age 54 years, 23 women). Five serious adverse events (hypotension, n = 2; hypertension, n = 1; vascular access complications, n = 2) and 2 transient ischemic attacks occurred within 30 days postprocedure. Two strokes and 1 transient ischemic attack occurred more than 2 years postimplantation. Mean office BP at baseline was 181 ± 17/107 ± 16 mm Hg and decreased by 25/12 mm Hg (95% CI: 17-33/8-17 mm Hg) at 6 months and 30/12 mm Hg (95% CI: 21-38/8-17 mm Hg) at 3 years. Mean 24-hour ambulatory BP at baseline was 166 ± 16/98 ± 15 mm Hg and decreased by 20/11 mm Hg (95% CI: 14-25/8-15 mm Hg) at 6 months. CONCLUSIONS: EVBA with the MobiusHD was effective in reducing BP at 3-year follow-up and appears to have an acceptable safety profile in patients with uncomplicated implantation, although data from randomized sham-controlled trials are needed to further evaluate the risk-benefit profile. (Controlling and Lowering Blood Pressure With the MobiusHD™ [CALM-FIM_EUR], NCT01911897; Controlling and Lowering Blood Pressure With the MobiusHD™ [CALM-FIM_US], NCT01831895).

Transcatheter Edge-to-Edge Repair in Proportionate Versus Disproportionate Functional Mitral Regurgitation.

BACKGROUND: Functional mitral regurgitation (FMR) can be subclassified on the basis of its proportionality relative to left ventricular (LV) volume and function, indicating potential differences in underlying etiology. The aim of this study was to evaluate the association of FMR proportionality with FMR reduction, heart failure hospitalization and mortality after transcatheter edge-to-edge mitral valve repair (TEER). METHODS: This multicenter registry included 241 patients with symptomatic heart failure with reduced LV ejection fraction treated with TEER for moderate to severe or greater FMR. FMR proportionality was graded on preprocedural transthoracic echocardiography using the ratio of the effective regurgitant orifice area to LV end-diastolic volume. Baseline characteristics, follow-up transthoracic echocardiography, and 2-year clinical outcomes were compared between groups. RESULTS: Median LV ejection fraction, effective regurgitant orifice area and LV end-diastolic volume index were 30% (interquartile range [IQR], 25%-35%), 27 mm2, and 107 mL/m2 (IQR, 90-135 mL/m2), respectively. Median effective regurgitant orifice area/LV end-diastolic volume ratio was 0.13 (IQR, 0.10-0.18). Proportionate FMR (pFMR) and disproportionate FMR (dFMR) was present in 123 and 118 patients, respectively. Compared with patients with pFMR, those with dFMR had higher baseline LV ejection fractions (median, 32% [IQR, 27%-39%] vs 26% [IQR, 22%-33%]; P < .01). Early FMR reduction with TEER was more pronounced in patients with dFMR (odds ratio, 0.45; 95% CI, 0.28-0.74; P < .01) than those with pFMR, but not at 12 months (odds ratio, 0.93; 95% CI, 0.53-1.63; P = .80). Overall, in 35% of patients with initial FMR reduction after TEER, FMR deteriorated again at 1-year follow-up. Rates of 2-year all-cause mortality and heart failure hospitalization were 30% (n = 66) and 37% (n = 76), with no differences between dFMR and pFMR. CONCLUSIONS: TEER resulted in more pronounced early FMR reduction in patients with dFMR compared with those with pFMR. Yet after initial improvement, FMR deteriorated in a substantial number of patients, calling into question durable mitral regurgitation reductions with TEER in selected patients. The proportionality framework may not identify durable TEER responders.

Aspirin with or without Clopidogrel after Transcatheter Aortic-Valve Implantation.

BACKGROUND: The effect of single as compared with dual antiplatelet treatment on bleeding and thromboembolic events after transcatheter aortic-valve implantation (TAVI) in patients who do not have an indication for long-term anticoagulation has not been well studied. METHODS: In a randomized, controlled trial, we assigned a subgroup of patients who were undergoing TAVI and did not have an indication for long-term anticoagulation, in a 1:1 ratio, to receive aspirin alone or aspirin plus clopidogrel for 3 months. The two primary outcomes were all bleeding (including minor, major, and life-threatening or disabling bleeding) and non-procedure-related bleeding over a period of 12 months. Most bleeding at the TAVI puncture site was counted as non-procedure-related. The two secondary outcomes were a composite of death from cardiovascular causes, non-procedure-related bleeding, stroke, or myocardial infarction (secondary composite 1) and a composite of death from cardiovascular causes, ischemic stroke, or myocardial infarction (secondary composite 2) at 1 year, with both outcomes tested sequentially for noninferiority (noninferiority margin, 7.5 percentage points) and superiority. RESULTS: A total of 331 patients were assigned to receive aspirin alone and 334 were assigned to receive aspirin plus clopidogrel. A bleeding event occurred in 50 patients (15.1%) receiving aspirin alone and in 89 (26.6%) receiving aspirin plus clopidogrel (risk ratio, 0.57; 95% confidence interval [CI], 0.42 to 0.77; P = 0.001). Non-procedure-related bleeding occurred in 50 patients (15.1%) and 83 patients (24.9%), respectively (risk ratio, 0.61; 95% CI, 0.44 to 0.83; P = 0.005). A secondary composite 1 event occurred in 76 patients (23.0%) receiving aspirin alone and in 104 (31.1%) receiving aspirin plus clopidogrel (difference, -8.2 percentage points; 95% CI for noninferiority, -14.9 to -1.5; P<0.001; risk ratio, 0.74; 95% CI for superiority, 0.57 to 0.95; P = 0.04). A secondary composite 2 event occurred in 32 patients (9.7%) and 33 patients (9.9%), respectively (difference, -0.2 percentage points; 95% CI for noninferiority, -4.7 to 4.3; P = 0.004; risk ratio, 0.98; 95% CI for superiority, 0.62 to 1.55; P = 0.93). A total of 44 patients (13.3%) and 32 (9.6%), respectively, received oral anticoagulation during the trial. CONCLUSIONS: Among patients undergoing TAVI who did not have an indication for oral anticoagulation, the incidence of bleeding and the composite of bleeding or thromboembolic events at 1 year were significantly less frequent with aspirin than with aspirin plus clopidogrel administered for 3 months. (Funded by the Netherlands Organization for Health Research and Development; POPular TAVI EU Clinical Trials Register number, 2013-003125-28; ClinicalTrials.gov number, NCT02247128.).

Titanium-Nitride-Oxide-Coated Versus Everolimus-Eluting Stents in Acute Coronary Syndrome: The Randomized TIDES-ACS Trial.

OBJECTIVES: This study sought to compare next-generation cobalt-chromium-based titanium-nitride-oxide (TiNO)-coated stents with a platinum-chromium-based biodegradable polymer everolimus-eluting stent (EES) in patients with acute coronary syndrome (ACS). BACKGROUND: Previous generation TiNO-coated stents showed acceptable performance in patients with ACS. METHODS: In a multicenter, randomized trial, we randomly assigned 1,491 ACS patients (2:1) to receive either a TiNO-coated stent (n = 989) or EES (n = 502). The primary endpoint was the rate of a composite of cardiac death, myocardial infarction (MI), or ischemia-driven target lesion revascularization at 12-month follow-up. The co-primary endpoint was a composite of cardiac death, MI, or major bleeding at 18 months. RESULTS: A primary endpoint event occurred in 6.3% of patients in the TiNO-coated stent group versus in 7.0% in the EES group (hazard ratio: 0.93; 95% confidence interval: 0.71 to 1.22; p = 0.66 for superiority; p < 0.001 for noninferiority). A co-primary endpoint event occurred in 3.7% of the patients in the TiNO group and in 7.8% in the EES group (hazard ratio: 0.64; 95% confidence interval: 0.51 to 0.80; p = 0.001). TiNO-coated stents were associated with lower rates of cardiac death (0.6% vs. 2.6%; p = 0.002) and MI (2.2% vs. 5.0%; p = 0.007) at 18 months of follow-up. Rates of target lesion revascularization were not significantly different at 18 months (5.8% vs. 4.4%; p = 0.27). CONCLUSIONS: In patients with ACS, cobalt-chromium-based TiNO-coated stents were noninferior to platinum-chromium-based biodegradable polymer EES for major cardiac events at 12 months, and were superior for the co-primary endpoint of cardiac death, MI, and bleeding at 18 months. (Comparison of Titanium-Nitride-Oxide-Coated Bio-Active-Stent (Optimax™) to the Drug (Everolimus) -Eluting Stent (Synergy™) in Acute Coronary Syndrome [TIDES-ACS]; NCT02049229).

Impact of predilatation prior to transcatheter aortic valve implantation with the self-expanding acurate neo device (From the Multicenter NEOPRO Registry)

Safety and feasibility of transfemoral Acurate neo implantation without systematic predilatation are not fully investigated. Our aim was to evaluate the use and impact of pre-implantation balloon aortic valvuloplasty (pre-BAV) before transcatheter aortic valve implantation (TAVI) with Acurate neo. The NEOPRO Registry retrospectively included 1,263 patients who underwent transfemoral TAVI with Acurate neo at 18 centers between January 2012 and March 2018. Information on preBAV was available for 1,262 patients (99.9%). Primary endpoints were pre-discharge moderate-tosevere paravalvular aortic regurgitation (PAR II+), 30-day new permanent pacemaker implantation (PPI), and 30-day all-cause mortality or stroke. A total of 1,262 patients who underwent TAVI with (n=1,051) or without predilatation (n=211) were included. A reduction in the pre-BAV rate was observed during the study period (from 95.7% in the first date quintile to 78.4% in the last date quintile). Patients who underwent pre-BAV had higher degrees of aortic valve (AV) and left ventricular outflow tract (LVOT) calcification. Primary endpoints were similar between pre-BAV and no pre-BAV groups (PAR II+ 5.5% vs. 3.4%, p=0.214; 30-day PPI 9.0% vs. 8.0%, p=0.660; 30-day death or stroke 4.9% vs. 4.4%, p=0.743). The need for postdilatation and other procedural outcomes were comparable between groups. Predilatation did not have a significant impact on primary endpoints across AV and LVOT calcification subgroups (subgroup analyses) and was not independently associated with primary endpoints (multivariate analyses). In conclusion, transfemoral Acurate neo implantation without predilatation appears to be feasible and safe, especially in patients with milder degrees of AV and LVOT calcification. (AU)

Left Ventricular End-Systolic Dimension and Outcome in Patients With Heart Failure Undergoing Percutaneous MitraClip Valve Repair for Secondary Mitral Regurgitation.

Recent MitraClip heart failure (HF) trials suggest that baseline left ventricular (LV) remodeling may be critical for patient selection. We, therefore, investigated whether baseline LV remodeling affects safety, efficacy, and clinical outcomes in HF patients with symptomatic secondary mitral regurgitation (MR) undergoing percutaneous mitral valve repair using MitraClip. LV remodeling was assessed by LV end-systolic dimension index (LVESDi) on transthoracic baseline echocardiography. Early and late outcome was reported using Mitral Valve Academic Research Consortium-criteria. A total of 107 consecutive HF patients (73 ± 10 years, 70% male) who underwent MitraClip intervention for secondary MR were studied. The study population was stratified by median LVESDi between nonadvanced (<28 mm/m², n = 49) and advanced LV remodeling (≥28 mm/m², n = 58). Both groups had similar acute procedural success, in hospital bleeding and nonbleeding complications and significant improvement in MR severity and symptoms, sustained up to 36 months (all p >0.05). LVESDi, but not LV end-diastolic diameter index nor LV ejection fraction, independently related to HF hospitalization (hazard ratio 1.11, 95% confidence interval 1.05 to 1.16, p <0.001) and mortality (hazard ratio 1.11, 95% confidence interval 1.06 to 1.17, p <0.001). At 1 and 3 years, survival free of HF hospitalization was higher in patients without versus with advanced LV remodeling (89% vs 66% and 65% vs 37%, p = 0.002) and mortality was lower (9% vs 24% and 36% vs 47%, p = 0.074), respectively. Annual HF hospitalization rate only decreased in the nonadvanced LV remodeling group (-43%, p = 0.025). Advanced LV remodeling, assessed by LVESDi, in HF patients who underwent MitraClip therapy does not influence therapeutic safety nor efficacy, but implies increased HF hospitalization and mortality risk. This parameter may be valuable for MitraClip therapy patient selection.