Reducing length of stay after transfemoral transcatheter aortic valve implantation: the FAST-TAVI II trial.

BACKGROUND AND AIMS: The length of stay (LOS) after transcatheter aortic valve implantation (TAVI) remains extremely variable whereas early discharge has been shown to be feasible and safe. The study objective was to evaluate the efficacy and safety of an intervention aimed at reducing LOS after transfemoral TAVI. METHODS: FAST-TAVI II is a prospective, multicentre, cluster, randomized, controlled study including patients with severe symptomatic aortic stenosis, who had transfemoral TAVI. The intervention consisted in a dedicated training programme to implement 10 quality of care measures to reduce LOS with an implementation phase of eight weeks. The primary endpoint was the proportion of patients discharged early within 3 days. Secondary endpoints included: LOS, 30-day mortality and 30-day incidence of readmission for cardiovascular events. RESULTS: During the study period, 969 patients were enrolled in the intervention group and 860 patients in the control group. Mean age was 81.9 ± 6.6 years and mean EuroSCORE II was 4.4 ± 4.5%. Early discharge was achieved in 563 (58.1%) patients in the intervention group vs. 364 (42.3%) patients in the control group (P < .0001). Median LOS was significantly reduced in the intervention group compared to the control group [3 (IQR: 3) vs. 4 days (IQR: 3), P < .0001]. Thirty-day mortality was low and similar in the two groups (0.5% vs. 0.9%, P = .30), as were 30-day readmissions (4.6% vs. 2.8%, P = .28). CONCLUSIONS: The intervention was simple and fast to implement, and was effective and safe to reduce LOS and increase the proportion of patients discharged early after TAVI (NCT04503655).

Mitral transcatheter edge-to-edge repair vs. isolated mitral surgery for severe mitral regurgitation: a French nationwide study.

BACKGROUND AND AIMS: Mitral valve surgery and, more recently, mitral transcatheter edge-to-edge repair (TEER) are the two treatments of severe mitral regurgitation in eligible patients. Clinical comparison of both therapies remains limited by the number of patients analysed. The objective of this study was to analyse the outcomes of mitral TEER vs. isolated mitral valve surgery at a nationwide level in France. METHODS: Based on the French administrative hospital discharge database, the study collected information for all consecutive patients treated for mitral regurgitation with isolated TEER or isolated mitral valve surgery between 2012 and 2022. Propensity score matching was used for the analysis of outcomes. RESULTS: A total of 57 030 patients were found in the database. After matching on baseline characteristics, 2160 patients were analysed in each arm. At 3-year follow-up, TEER was associated with significantly lower incidence of cardiovascular death (hazard ratio 0.685, 95% confidence interval 0.563-0.832; P = .0001), pacemaker implantation, and stroke. Non-cardiovascular death (hazard ratio 1.562, 95% confidence interval 1.238-1.971; P = .0002), recurrent pulmonary oedema, and cardiac arrest were more frequent after TEER. No significant differences between the two groups were observed regarding all-cause death (hazard ratio 0.967, 95% confidence interval 0.835-1.118; P = .65), endocarditis, major bleeding, atrial fibrillation, and myocardial infarction. CONCLUSIONS: Our results suggest that TEER for severe mitral regurgitation was associated with lower cardiovascular mortality than mitral surgery at long-term follow-up. Pacemaker implantation and stroke were less frequently observed after TEER.

Device innovation in cardiovascular medicine: a report from the European Society of Cardiology Cardiovascular Round Table.

Research performed in Europe has driven cardiovascular device innovation. This includes, but is not limited to, percutaneous coronary intervention, cardiac imaging, transcatheter heart valve implantation, and device therapy of cardiac arrhythmias and heart failure. An important part of future medical progress involves the evolution of medical technology and the ongoing development of artificial intelligence and machine learning. There is a need to foster an environment conducive to medical technology development and validation so that Europe can continue to play a major role in device innovation while providing high standards of safety. This paper summarizes viewpoints on the topic of device innovation in cardiovascular medicine at the European Society of Cardiology Cardiovascular Round Table, a strategic forum for high-level dialogue to discuss issues related to the future of cardiovascular health in Europe. Devices are developed and improved through an iterative process throughout their lifecycle. Early feasibility studies demonstrate proof of concept and help to optimize the design of a device. If successful, this should ideally be followed by randomized clinical trials comparing novel devices vs. accepted standards of care when available and the collection of post-market real-world evidence through registries. Unfortunately, standardized procedures for feasibility studies across various device categories have not yet been implemented in Europe. Cardiovascular imaging can be used to diagnose and characterize patients for interventions to improve procedural results and to monitor devices long term after implantation. Randomized clinical trials often use cardiac imaging-based inclusion criteria, while less frequently trials randomize patients to compare the diagnostic or prognostic value of different modalities. Applications using machine learning are increasingly important, but specific regulatory standards and pathways remain in development in both Europe and the USA. Standards are also needed for smart devices and digital technologies that support device-driven biomonitoring. Changes in device regulation introduced by the European Union aim to improve clinical evidence, transparency, and safety, but they may impact the speed of innovation, access, and availability. Device development programmes including dialogue on unmet needs and advice on study designs must be driven by a community of physicians, trialists, patients, regulators, payers, and industry to ensure that patients have access to innovative care.

Overcoming professional barriers encountered by women in interventional cardiology: an EAPCI statement.

Despite the increasing proportion of female medical and nursing students, there is still a significant under-representation of women working as healthcare providers in interventional cardiology, with very few of them reaching senior leadership, academic positions, or acting principal investigators, as well as actively involved in company advisory boards. In this position paper, we will describe the current status of women working in interventional cardiology across Europe. We will also provide an overview of the most relevant determinants of the under-representation of women at each stage of the interventional cardiology career path and offer practical suggestions for overcoming these challenges.

A Controlled Trial of Rivaroxaban after Transcatheter Aortic-Valve Replacement.

BACKGROUND: Whether the direct factor Xa inhibitor rivaroxaban can prevent thromboembolic events after transcatheter aortic-valve replacement (TAVR) is unclear. METHODS: We randomly assigned 1644 patients without an established indication for oral anticoagulation after successful TAVR to receive rivaroxaban at a dose of 10 mg daily (with aspirin at a dose of 75 to 100 mg daily for the first 3 months) (rivaroxaban group) or aspirin at a dose of 75 to 100 mg daily (with clopidogrel at a dose of 75 mg daily for the first 3 months) (antiplatelet group). The primary efficacy outcome was the composite of death or thromboembolic events. The primary safety outcome was major, disabling, or life-threatening bleeding. The trial was terminated prematurely by the data and safety monitoring board because of safety concerns. RESULTS: After a median of 17 months, death or a first thromboembolic event (intention-to-treat analysis) had occurred in 105 patients in the rivaroxaban group and in 78 patients in the antiplatelet group (incidence rates, 9.8 and 7.2 per 100 person-years, respectively; hazard ratio with rivaroxaban, 1.35; 95% confidence interval [CI], 1.01 to 1.81; P = 0.04). Major, disabling, or life-threatening bleeding (intention-to-treat analysis) had occurred in 46 and 31 patients, respectively (4.3 and 2.8 per 100 person-years; hazard ratio, 1.50; 95% CI, 0.95 to 2.37; P = 0.08). A total of 64 deaths occurred in the rivaroxaban group and 38 in the antiplatelet group (5.8 and 3.4 per 100 person-years, respectively; hazard ratio, 1.69; 95% CI, 1.13 to 2.53). CONCLUSIONS: In patients without an established indication for oral anticoagulation after successful TAVR, a treatment strategy including rivaroxaban at a dose of 10 mg daily was associated with a higher risk of death or thromboembolic complications and a higher risk of bleeding than an antiplatelet-based strategy. (Funded by Bayer and Janssen Pharmaceuticals; GALILEO ClinicalTrials.gov number, NCT02556203.).

Trends in aortic valve replacement for aortic stenosis: a French nationwide study.

AIMS: Transcatheter aortic valve replacement (TAVR) as an alternative to surgical aortic valve replacement (SAVR) has profoundly changed the management of patients with aortic valve stenosis (AS). Large unbiased nationwide data regarding TAVR implementation, impact on SAVR and their respective outcomes are scarce. METHODS AND RESULTS: Based on a French administrative hospital-discharge database, we collected data on all consecutive aortic valve replacements (AVRs) performed in France for AS between 2007 and 2019 [106 253 isolated SAVR (49%), 46 514 combined SAVR (21%), and 65 651 TAVR (30%)]. The number of AVR linearly increased between 2007 and 2019 (from 10 892 to 23 109, P for trend < 0.0001) due to a marked increase in TAVR (from 253 to 13 030, P for trend < 0.0001), while SAVR increased up to 2013 and then declined (10 892 in 2007, 12 699 in 2013, and 10 079 in 2019). The Charlson index decreased linearly for TAVR, but in two steps for SAVR (2011 and 2017). In-hospital mortality rates of both SAVR and TAVR declined (both P for trend < 0.0001) and were similar or lower for TAVR than for isolated SAVR in patients 75 years or above in the last 3 years (2017-19). Complication rates of TAVR also declined but permanent pacemaker rates remained high and length of stay substantial (16.7% and median 6 days, respectively, in 2017-19). CONCLUSION: The number of AVR has doubled in a decade and TAVR has become the dominant form of AVR in 2018. The improvement in patient profiles seems to have anticipated the demonstrated benefit of TAVR in intermediate and low-risk patients. In patients 75 years or older, TAVR should be considered as the first option. We also highlight two important areas for improvement, the high permanent pacemaker rates, and the long length of stay even in the contemporary era. Our results may have major implications for clinical practice and policymakers.

Trends in aortic valve replacement for aortic stenosis: a French nationwide study.

AIMS: Transcatheter aortic valve replacement (TAVR) as an alternative to surgical aortic valve replacement (SAVR) has profoundly changed the management of patients with aortic valve stenosis (AS). Large unbiased nationwide data regarding TAVR implementation, impact on SAVR and their respective outcomes are scarce. METHODS AND RESULTS: Based on a French administrative hospital-discharge database, we collected data on all consecutive aortic valve replacements (AVRs) performed in France for AS between 2007 and 2019 [106 253 isolated SAVR (49%), 46 514 combined SAVR (21%), and 65 651 TAVR (30%)]. The number of AVR linearly increased between 2007 and 2019 (from 10 892 to 23 109, P for trend < 0.0001) due to a marked increase in TAVR (from 253 to 13 030, P for trend < 0.0001), while SAVR increased up to 2013 and then declined (10 892 in 2007, 12 699 in 2013, and 10 079 in 2019). The Charlson index decreased linearly for TAVR, but in two steps for SAVR (2011 and 2017). In-hospital mortality rates of both SAVR and TAVR declined (both P for trend < 0.0001) and were similar or lower for TAVR than for isolated SAVR in patients 75 years or above in the last 3 years (2017-19). Complication rates of TAVR also declined but permanent pacemaker rates remained high and length of stay substantial (16.7% and median 6 days, respectively, in 2017-19). CONCLUSION: The number of AVR has doubled in a decade and TAVR has become the dominant form of AVR in 2018. The improvement in patient profiles seems to have anticipated the demonstrated benefit of TAVR in intermediate and low-risk patients. In patients 75 years or older, TAVR should be considered as the first option. We also highlight two important areas for improvement, the high permanent pacemaker rates, and the long length of stay even in the contemporary era. Our results may have major implications for clinical practice and policymakers.

Apixaban vs. standard of care after transcatheter aortic valve implantation: the ATLANTIS trial.

AIMS: The respective roles of oral anticoagulation or antiplatelet therapy following transcatheter aortic valve implantation (TAVI) remain debated. ATLANTIS is an international, randomized, open-label, superiority trial comparing apixaban to the standard of care. METHODS AND RESULTS: After successful TAVI, 1500 patients were randomized (1:1) to receive apixaban 5 mg (2.5 mg if impaired renal function or concomitant antiplatelet therapy) (n = 749) twice daily, or standard of care (n = 751). Randomization was stratified by the need for chronic anticoagulation therapy. Standard-of-care patients received a vitamin K antagonist (VKA) (Stratum 1) or antiplatelet therapy (Stratum 2) if there was an indication for anticoagulation or not, respectively. The primary endpoint was the composite of death, myocardial infarction, stroke or transient ischaemic attack, systemic embolism, intracardiac or bioprosthesis thrombosis, deep vein thrombosis or pulmonary embolism, and life-threatening, disabling, or major bleeding over 1-year follow-up. The primary safety endpoint was major, disabling, or life-threatening bleeding. The primary outcome occurred in 138 (18.4%) and 151 (20.1%) patients receiving apixaban or standard of care, respectively [hazard ratio (HR) 0.92; 95% confidence interval (CI) 0.73-1.16] and there was no evidence of interaction between treatment and stratum (Pinteraction = 0.57). The primary safety endpoint was similar in both groups (HR 1.02; 95% CI 0.72-1.44). In Stratum 1 (n = 451), an exploratory analysis showed no difference for all endpoints between apixaban and VKA. In Stratum 2 (n = 1049), the primary outcome and primary safety endpoint did not differ, but obstructive valve thrombosis was reduced with apixaban vs. antiplatelet therapy (HR 0.19; 95% CI 0.08-0.46), while a signal of higher non-cardiovascular mortality was observed with apixaban. CONCLUSION: After TAVI, apixaban was not superior to the standard of care, irrespective of an indication for oral anticoagulation.

Mitral valve-in-valve and valve-in-ring procedures: Midterm outcomes in a French nationwide registry.

OBJECTIVES: Report contemporary outcomes in patients included in the Mitragister registry and treated with transcatheter mitral valve implantation for failed surgical annuloplasty rings or deteriorated bioprosthesis. BACKGROUND: Midterm survival rates have been reported, but little is known about contemporary morbimortality endpoints. METHODS: The primary safety outcome was the technical success rate. The primary efficacy composite endpoint was a composite of cardiovascular mortality and heart failure hospitalizations. RESULTS: From 2016 to 2021, 102 patients (median age: 81 [74;84] years, 61% female, Euroscore II 11.0% [7.8;16.0]) undergoing valve-in-valve (ViV; n = 89) or valve-in-ring (ViR; n = 13) procedures were consecutively included. At baseline, ViR group patients had worse left ventricular ejection fraction (50% vs. 60%; p = 0.004) and more frequently severe regurgitation (46% vs. 15%; p = 0.014). The primary safety outcome was 95%: 77% and 98% in the ViR and ViV populations, respectively, (p = 0.014). At intermediate follow-up (6-12 months) clinical improvement was notable, 88% of the patients were in NYHA class ≤ II (vs. 25% at baseline; p < 0.001). At a mean follow-up of 17.1 ± 11.0 months, the primary efficacy composite reached 27%. By multivariate analysis, paravalvular leak (PVL) was the only independent predictor (hazard ratio: 2.39, 95% confidence interval: 1.08-5.29; p = 0.031) while ViR was not found statistically associated (p = 0.456). CONCLUSIONS: This study confirms the safety and efficacy of the mitral ViV procedure. ViR patients appear at higher risk of procedural complications. The presence of PVL could be associated with markedly worse midterm prognosis. Whatever the intervention, procedural strategies to reduce PVL incidence remain to be assessed to prevent latter adverse outcomes.

Two-year clinical outcomes after successful transcatheter aortic valve implantation with balloon-expandable versus self-expanding valves: A subanalysis of the GALILEO trial.

BACKGROUND: Midterm data comparing clinical outcomes after successful implantation of self-expanding and balloon-expandable transcatheter heart valves (THV) are limited. We aimed to compare 2-year outcomes after successful transcatheter aortic valve implantation (TAVI) with the Edwards balloon-expandable or the Medtronic self-expanding THV. METHODS: Two-year outcomes were analyzed according to the implanted THV in the GALILEO trial. Major adverse cardiac and cerebrovascular events (MACCE) was a composite of all-cause death or thromboembolic events including stroke, myocardial infarction, symptomatic valve thrombosis, systemic embolism, deep-vein thrombosis, or pulmonary embolism. RESULTS: Among 1644 patients recruited in 136 centers across 16 countries between 2015 and 2018, 499 received a self-expanding and 757 patients received a balloon-expandable THV. Patients treated with a self-expanding THV were more likely to be female, and had higher surgical risk, lower hemoglobin levels, and more frequent valve-in-valve procedures than those with a balloon-expandable THV. After multivariable adjustment, there were no significant differences in major clinical outcomes between self-expanding versus balloon-expandable THV: MACCE (17.0% vs. 13.4%, adjusted-hazard ratios [HR] 1.18, 95% confidence intervals [CI]: 0.82-1.69); all-cause death (11.4% vs. 9.3%, adjusted-HR 1.26; 95% CI: 0.78-2.05); cardiovascular death (8.5% vs. 4.0%, adjusted-HR 1.53; 95% CI: 0.82-2.86), any stroke (5.1% vs. 3.7%, adjusted-HR 0.86; 95% CI: 0.43-1.73); major or life-threatening bleeding (5.9% vs. 6.8%, adjusted-HR 0.93; 95% CI: 0.53-1.63). CLINICAL TRIAL REGISTRATION: https://www. CLINICALTRIALS: gov. NCT02556203. CONCLUSIONS: Two-year follow-up data from the GALILEO trial indicate that successful TAVI either with self-expanding or balloon-expandable THVs according to physician discretion did not show difference in rates of MACCE.

Cost-Effectiveness Analysis of SAPIEN 3 Transcatheter Aortic Valve Implantation Procedure Compared With Surgery in Patients With Severe Aortic Stenosis at Low Risk of Surgical Mortality in France.

OBJECTIVES: The clinical and cost-saving benefits of transcatheter aortic valve implantation (TAVI) over surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis who are at high or intermediate risk of surgical mortality are supported by a growing evidence base. The PARTNER 3 trial (Placement of AoRTic TraNscathetER Valve Trial) demonstrated clinical benefits with SAPIEN 3 TAVI compared with SAVR in selected patients at low risk of surgical mortality. This study uses PARTNER 3 outcomes in combination with a French national hospital claim database to inform a cost-utility model and examine the cost implications of TAVI over SAVR in a low-risk population. METHODS: A 2-stage cost-utility analysis was developed to estimate changes in both direct healthcare costs and health-related quality of life using TAVI with SAPIEN 3 compared with SAVR. Early adverse events associated with TAVI were captured using the PARTNER 3 data set. These data fed into a Markov model that captured longer-term outcomes of patients, after TAVI or SAVR intervention. RESULTS: TAVI with SAPIEN 3 offers meaningful benefits over SAVR in providing both cost saving (€12 742 per patient) and generating greater quality-adjusted life-years (0.89 per patient). These results are robust with TAVI with SAPIEN 3 remaining dominant across several scenarios and deterministic and probabilistic sensitivity analyses. CONCLUSIONS: This model demonstrated that TAVI with SAPIEN 3 was dominant compared with SAVR in the treatment of patients with severe symptomatic aortic stenosis who are at low risk of surgical mortality. These findings should help policy makers in developing informed approaches to intervention selection for this patient population.

Management of antithrombotic therapy in patients undergoing transcatheter aortic valve implantation: a consensus document of the ESC Working Group on Thrombosis and the European Association of Percutaneous Cardiovascular Interventions (EAPCI), in collaboration with the ESC Council on Valvular Heart Disease.

Transcatheter aortic valve implantation (TAVI) is effective in older patients with symptomatic severe aortic stenosis, while the indication has recently broadened to younger patients at lower risk. Although thromboembolic and bleeding complications after TAVI have decreased over time, such adverse events are still common. The recommendations of the latest 2017 ESC/EACTS Guidelines for the management of valvular heart disease on antithrombotic therapy in patients undergoing TAVI are mostly based on expert opinion. Based on recent studies and randomized controlled trials, this viewpoint document provides updated therapeutic insights in antithrombotic treatment during and after TAVI.

Comparison of Self-Expanding Bioprostheses for Transcatheter Aortic Valve Replacement in Patients With Symptomatic Severe Aortic Stenosis: SCOPE 2 Randomized Clinical Trial.

BACKGROUND: Few randomized trials have compared bioprostheses for transcatheter aortic valve replacement, and no trials have compared bioprostheses with supra-annular design. The SCOPE 2 trial (Safety and Efficacy Comparison of Two TAVI Systems in a Prospective Randomized Evaluation 2) was designed to compare the clinical outcomes of the ACURATE neo and CoreValve Evolut bioprostheses for transcatheter aortic valve replacement. METHODS: SCOPE 2 was a randomized trial performed at 23 centers in 6 countries between April 2017 and April 2019. Patients ≥75 years old with an indication for transfemoral transcatheter aortic valve replacement as agreed by the heart team were randomly assigned to receive treatment with either the ACURATE neo (n=398) or the CoreValve Evolut bioprostheses (n=398). The primary end point, powered for noninferiority of the ACURATE neo bioprosthesis, was all-cause death or stroke at 1 year. The key secondary end point, powered for superiority of the ACURATE neo bioprosthesis, was new permanent pacemaker implantation at 30 days. RESULTS: Among 796 randomized patients (mean age, 83.2±4.3 years; mean Society of Thoracic Surgeons Predicted Risk of Mortality score, 4.6±2.9%), clinical follow-up information was available for 778 (98%) patients. Within 1 year, the primary end point occurred in 15.8% of patients in the ACURATE neo group and in 13.9% of patients in the CoreValve Evolut group (absolute risk difference, 1.8%, upper 1-sided 95% confidence limit, 6.1%; P=0.0549 for noninferiority). The 30-day rates of new permanent pacemaker implantation were 10.5% in the ACURATE neo group and 18.0% in the CoreValve Evolut group (absolute risk difference, -7.5% [95% CI, -12.4 to -2.60]; P=0.0027). No significant differences were observed in the components of the primary end point. Cardiac death at 30 days (2.8% versus 0.8%; P=0.03) and 1 year (8.4% versus 3.9%; P=0.01), and moderate or severe aortic regurgitation at 30 days (10% versus 3%; P=0.002) were significantly increased in the ACURATE neo group. CONCLUSIONS: Transfemoral transcatheter aortic valve replacement with the self-expanding ACURATE neo did not meet noninferiority compared with the self-expanding CoreValve Evolut in terms of all-cause death or stroke at 1 year, and it was associated with a lower incidence of new permanent pacemaker implantation. In secondary analyses, the ACURATE neo was associated with more moderate or severe aortic regurgitation at 30 days and cardiac death at 30 days and 1 year. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03192813.

Balloon-Expandable Versus Self-Expanding Transcatheter Aortic Valve Replacement: A Propensity-Matched Comparison From the FRANCE-TAVI Registry.

BACKGROUND: No randomized study powered to compare balloon expandable (BE) with self expanding (SE) transcatheter heart valves (THVs) on individual end points after transcatheter aortic valve replacement has been conducted to date. METHODS: From January 2013 to December 2015, the FRANCE-TAVI nationwide registry (Registry of Aortic Valve Bioprostheses Established by Catheter) included 12 141 patients undergoing BE-THV (Edwards, n=8038) or SE-THV (Medtronic, n=4103) for treatment of native aortic stenosis. Long term mortality status was available in all patients (median 20 months; interquartile range, 14 to 30). Patients treated with BE-THV (n=3910) were successfully matched 1:1 with 3910 patients treated with SE-THV by using propensity score (25 clinical, anatomical, and procedural variables) and by date of the procedure (within 3 months). The first coprimary outcome was ≥ moderate occurrence of paravalvular regurgitation or in-hospital mortality, or both. The second coprimary outcome was 2-year all-cause mortality. RESULTS: In propensity-matched analyses, the incidence of the first coprimary outcome was higher with SE-THV (19.8%) compared with BE-THV (11.9%; relative risk, 1.68 [95% CI, 1.46-1.91]; P<0.0001). Each component of the outcome was also higher in patients receiving SE-THV: ≥ moderate paravalvular regurgitation (15.5% versus 8.3%; relative risk, 1.90 [95% CI, 1.63-2.22]; P<0.0001) and in hospital mortality (5.6% versus 4.2%; relative risk, 1.34 [95% CI, 1.07-1.66]; P=0.01). During follow up, all cause mortality occurred in 899 patients treated with SE-THV (2-year mortality, 29.8%) and in 801 patients treated with BE-THV (2-year mortality, 26.6%; hazard ratio, 1.17 [95% CI, 1.06-1.29]; P=0.003). Similar results were found using inverse probability of treatment weighting using propensity score analysis. CONCLUSION: The present study suggests that use of SE-THV was associated with a higher risk of paravalvular regurgitation and higher in-hospital and 2-year mortality compared with use of BE-THV. These data strongly support the need for a randomized trial sufficiently powered to compare the latest generation of SE-THV and BE-THV. CLINICAL TRIAL REGISTRATION: https://www.clinicaltrials.gov. Unique identifier: NCT01777828.

Percutaneous Repair or Medical Treatment for Secondary Mitral Regurgitation.

BACKGROUND: In patients who have chronic heart failure with reduced left ventricular ejection fraction, severe secondary mitral-valve regurgitation is associated with a poor prognosis. Whether percutaneous mitral-valve repair improves clinical outcomes in this patient population is unknown. METHODS: We randomly assigned patients who had severe secondary mitral regurgitation (defined as an effective regurgitant orifice area of >20 mm2 or a regurgitant volume of >30 ml per beat), a left ventricular ejection fraction between 15 and 40%, and symptomatic heart failure, in a 1:1 ratio, to undergo percutaneous mitral-valve repair in addition to receiving medical therapy (intervention group; 152 patients) or to receive medical therapy alone (control group; 152 patients). The primary efficacy outcome was a composite of death from any cause or unplanned hospitalization for heart failure at 12 months. RESULTS: At 12 months, the rate of the primary outcome was 54.6% (83 of 152 patients) in the intervention group and 51.3% (78 of 152 patients) in the control group (odds ratio, 1.16; 95% confidence interval [CI], 0.73 to 1.84; P=0.53). The rate of death from any cause was 24.3% (37 of 152 patients) in the intervention group and 22.4% (34 of 152 patients) in the control group (hazard ratio, 1.11; 95% CI, 0.69 to 1.77). The rate of unplanned hospitalization for heart failure was 48.7% (74 of 152 patients) in the intervention group and 47.4% (72 of 152 patients) in the control group (hazard ratio, 1.13; 95% CI, 0.81 to 1.56). CONCLUSIONS: Among patients with severe secondary mitral regurgitation, the rate of death or unplanned hospitalization for heart failure at 1 year did not differ significantly between patients who underwent percutaneous mitral-valve repair in addition to receiving medical therapy and those who received medical therapy alone. (Funded by the French Ministry of Health and Research National Program and Abbott Vascular; MITRA-FR ClinicalTrials.gov number, NCT01920698 .).

Stent Size Optimization in the Femoral Bifurcation Using a Fractal Model: A Morphological Analysis.

OBJECTIVES: Stenting of common femoral artery (CFA) bifurcation lesions is complex due to harmonious asymmetric geometry between the CFA and deep or superficial femoral artery. In order to ensure an optimal flow, the stents must be implanted according to the diameter of the CFA and the diameter of the daughter vessels. The aim of this study was to validate a mathematical formula for the CFA bifurcation in order to optimize the implantation of stents in this bifurcation with a fast and efficient method. MATERIALS/METHODS: We retrospectively included all patients who underwent transcatheter aortic valve implantation and who had a healthy CFA bifurcation on the CT-scan. Diameters of the mother vessel (Dm), daughter vessels (Dl: larger vessel; Ds: smaller vessel), and the ratio between the two were calculated. According to the latter, the following linear model was proposed: [Dm = (Dm/Dl + Ds) × (Dl + Ds)] and was compared to the four existing models (Murray, HK, Flow, Finet). Finally, we calculated the relative error between the prediction of the four models and the measurements. RESULTS: Overall, 110 CFA bifurcations were included. Mean CFA diameter was 7.75 ± 1.67 mm. Mean Dl diameter was 5.79 ± 1.21 mm and mean Ds diameter was 5.23 ± 1.09 mm. A reduction of 25 % was seen between the CFA and the larger daughter-vessel. The mean ratio between the CFA and the daughter vessels was 0.71. Our model [Dm = 0.71× (Dl + Ds)] and the flow law were the most accurate (relative difference of 1.59 ± 11.97% and 1.01 ± 11.94%, respectively). However, Murray's law had a statistically significant deviation from the real mother-vessel diameter (P < 0.001). CONCLUSIONS: We developed a simple fractal ratio between CFA and daughter vessels, which could be easily used in daily practice during CFA percutaneous reconstruction to identify the optimal diameters of the diseased vessels.

EAPCI Position Statement on Invasive Management of Acute Coronary Syndromes during the COVID-19 pandemic.

The coronavirus disease 2019 (COVID-19) pandemic poses an unprecedented challenge to healthcare worldwide. The infection can be life threatening and require intensive care treatment. The transmission of the disease poses a risk to both patients and healthcare workers. The number of patients requiring hospital admission and intensive care may overwhelm health systems and negatively affect standard care for patients presenting with conditions needing emergency interventions. This position statements aims to assist cardiologists in the invasive management of acute coronary syndrome (ACS) patients in the context of the COVID-19 pandemic. To that end, we assembled a panel of interventional cardiologists and acute cardiac care specialists appointed by the European Association of Percutaneous Cardiovascular Interventions (EAPCI) and from the Acute Cardiovascular Care Association (ACVC) and included the experience from the first and worst affected areas in Europe. Modified diagnostic and treatment algorithms are proposed to adapt evidence-based protocols for this unprecedented challenge. Various clinical scenarios, as well as management algorithms for patients with a diagnosed or suspected COVID-19 infection, presenting with ST- and non-ST-segment elevation ACS are described. In addition, we address the need for re-organization of ACS networks, with redistribution of hub and spoke hospitals, as well as for in-hospital reorganization of emergency rooms and cardiac units, with examples coming from multiple European countries. Furthermore, we provide a guidance to reorganization of catheterization laboratories and, importantly, measures for protection of healthcare providers involved with invasive procedures.

Outcomes of transfemoral balloon expandable transcatheter aortic valve implantation: Comparison of two subsequent valve generations.

BACKGROUND: The SAPIEN 3 (S3) addresses several limitations of the SAPIEN XT (SXT) for the performance of transfemoral (TF-) balloon expandable transcatheter aortic valve implantation (TAVI). OBJECTIVES: We aimed to determine whether their altered features translate into improved outcomes in a real-world TF-TAVI patient population. METHODS: Data for 3,314 patients were extracted from the European registries SOURCE-XT and SOURCE-3. Patients were propensity-score (PS) matched (n = 1,169/group). RESULTS: In the PS matched comparison, device success was higher in the S3 (99.2%) compared to the SXT group (98.2%; p = .04). S3 patients experienced a lower rate of procedural death (0.7 vs. 2.6%; p = .0004), moderate/severe paravalvular leakage (PVL; 1.4 vs. 5.5%; p < .0001), and procedure-related stroke (1.2 vs. 2.4%; p = .04) while higher rates of mean aortic valve gradients ≥20 mmHg, and new permanent pacemaker implantations were seen. At 30 days a lower rate of all-cause mortality was seen (2.1% vs. 4.3%; p = .003), which was preserved after 1 year (10.7% vs. 14.9%; p = .002). A Cox regression predicting 1-year mortality resulted in a hazard ratio of 0.684 in favor of S3 (p = .0026). The same was true of stroke (2.8% vs. 5.7%; p = .0007), and moderate/severe PVL (2.7 vs. 7.3%; p = .0002) at 1 year. The rate of new pacemaker implantations (13.6% vs. 9.5%; p = .001) and NYHA III/IV (12.8 vs. 8.6%; p = .004) was higher with the S3. CONCLUSIONS: The improved features of the S3 appear to translate into improved survival and reduced rates of adverse complications, with the exception of a higher rate of new pacemaker implantations.

Late discovery of left atrial appendage occluder device embolization: a case report.

BACKGROUND: Left atrial appendage (LAA) closure has been well evaluated in the prevention of stroke in patients with atrial fibrillation. Device embolization remains one of the most common complications. To the best of our knowledge, there have been no reports of late discovery of LAA occluder device embolization at 1.5 years after implantation. CASE PRESENTATION: We describe the case of a 77-year-old man who underwent uneventful LAA closure. Echocardiography performed the next day showed the device in place. The patient was discharged but was then lost to follow-up. 1.5 years later, he was admitted for ischemic stroke. Transesophageal echocardiography showed the absence of the occluder device in the LAA. Computed tomography scan of the abdomen showed the device in the abdominal aorta. Due to the high cardiovascular risk, the device was kept in place and the patient was treated medically. CONCLUSIONS: Per-procedural and late device embolization are not uncommon. Review of the literature however showed no report of late discovery of device embolization at 1.5 years. Follow-up echocardiography is mandatory for the detection of endothelialization or embolization.