LANDMARK comparison of early outcomes of newer-generation Myval transcatheter heart valve series with contemporary valves (Sapien and Evolut) in real-world individuals with severe symptomatic native aortic stenosis: a randomised non-inferiority trial

BACKGROUND Transcatheter aortic valve implantation is an established, guideline-endorsed treatment for severe aortic stenosis. Precise sizing of the balloon-expandable Myval transcatheter heart valve (THV) series with the aortic annulus is facilitated by increasing its diameter in 1•5 mm increments, compared with the usual 3 mm increments in valve size. The LANDMARK trial aimed to show non-inferiority of the Myval THV series compared with the contemporary THVs Sapien Series (Edwards Lifesciences, Irvine, CA, USA) or Evolut Series (Medtronic, Minneapolis, MN, USA). METHODS In this prospective, multinational, randomised, open-label, non-inferiority trial across 31 hospitals in 16 countries (Germany, France, Sweden, the Netherlands, Italy, Spain, New Zealand, Portugal, Greece, Hungary, Poland, Slovakia, Slovenia, Croatia, Estonia, and Brazil), 768 participants with severe symptomatic native aortic stenosis were randomly assigned (1:1) to the Myval THV or a contemporary THV. Eligibility was primarily decided by the heart team in accordance with 2021 European Society of Cardiology guidelines. As per the criteria of the third Valve Academic Research Consortium, the primary endpoint at 30 days was a composite of all-cause mortality, all stroke, bleeding (types 3 and 4), acute kidney injury (stages 2­4), major vascular complications, moderate or severe prosthetic valve regurgitation, and conduction system disturbances resulting in a permanent pacemaker implantation. Non-inferiority of the study device was tested in the intention-to-treat population using a non-inferiority margin of 10•44% and assuming an event rate of 26•10%. This trial is registered with ClinicalTrials.gov, NCT04275726, and EudraCT, 2020-000137-40, and is closed to new participants. FINDINGS Between Jan 6, 2021, and Dec 5, 2023, 768 participants with severe symptomatic native aortic stenosis were randomly assigned, 384 to the Myval THV and 384 to a contemporary THV. 369 (48%) participants had their sex recorded as female, and 399 (52%) as male. The mean age of participants was 80•0 years (SD 5•7) for those treated with the Myval THV and 80•4 years (5•4) for those treated with a contemporary THV. Median Society of Thoracic Surgeons scores were the same in both groups (Myval 2•6% [IQR 1•7­4•0] vs contemporary 2•6% [1•7­4•0]). The primary endpoint showed non-inferiority of the Myval (25%) compared with contemporary THV (27%), with a risk difference of ­2•3% (one-sided upper 95% CI 3•8, pnon-inferiority<0•0001). No significant difference was seen in individual components of the primary composite endpoint. INTERPRETATION In individuals with severe symptomatic native aortic stenosis, the Myval THV met its primary endpoint at 30 days.

Temporal Trends, Characteristics, and Outcomes of Infective Endocarditis After Transcatheter Aortic Valve Replacement

BACKGROUND: Procedural improvements combined with the contemporary clinical profile of patients undergoing transcatheter aortic valve replacement (TAVR) may have influenced the incidence and outcomes of infective endocarditis (IE) following TAVR. We aimed to determine the temporal trends, characteristics, and outcomes of IE post-TAVR. METHODS: Observational study including 552 patients presenting definite IE post-TAVR. Patients were divided in 2 groups according to the timing of TAVR (historical cohort [HC]: before 2014; contemporary cohort [CC]: after 2014). RESULTS: Overall incidence rates of IE were similar in both cohorts (CC vs HC: 5.45 vs 6.52 per 1000 person-years; P = .12), but the rate of early IE was lower in the CC (2.29‰ vs 4.89‰, P < .001). Enterococci were the most frequent microorganism. Most patients presented complicated IE (CC: 67.7%; HC: 69.6%; P = .66), but the rate of surgical treatment remained low (CC: 20.7%; HC: 17.3%; P = .32). The CC exhibited lower rates of in-hospital acute kidney injury (35.1% vs 44.6%; P = .036) and in-hospital (26.6% vs 36.4%; P = .016) and 1-year (37.8% vs 53.5%; P < .001) mortality. Higher logistic EuroScore, Staphylococcus aureus etiology, and complications (stroke, heart failure, and acute renal failure) were associated with in-hospital mortality in multivariable analyses (P < .05 for all). CONCLUSIONS: Although overall IE incidence has remained stable, the incidence of early IE has declined in recent years. The microorganism, high rate of complications, and very low rate of surgical treatment remained similar. In-hospital and 1-year mortality rates were high but progressively decreased over time.

Infective endocarditis following transcatheter aortic valve replacement: comparison of balloon- versus self-expandable valves

BACKGROUND: No data exist about the characteristics of infective endocarditis (IE) post-transcatheter aortic valve replacement (TAVR) according to transcatheter valve type. We aimed to determine the incidence, clinical characteristics, and outcomes of patients with IE post-TAVR treated with balloon-expandable valve (BEV) versus self-expanding valve (SEV) systems. METHODS: Data from the multicenter Infectious Endocarditis After TAVR International Registry was used to compare IE patients with BEV versus SEV. RESULTS: A total of 245 patients with IE post-TAVR were included (SEV, 47%; BEV, 53%). The timing between TAVR and IE was similar between groups (SEV, 5.5 [1.2-15] months versus BEV, 5.3 [1.7-11.4] months; P=0.89). Enterococcal IE was more frequent in the SEV group (36.5% versus 15.4%; P<0.01), and vegetation location differed according to valve type (stent frame, SEV, 18.6%; BEV, 6.9%; P=0.01; valve leaflet, SEV, 23.9%; BEV, 38.5%; P=0.01). BEV recipients had a higher rate of stroke/systemic embolism (20.0% versus 8.7%, adjusted OR: 2.46, 95% CI: 1.04-5.82, P=0.04). Surgical explant of the transcatheter valve (SEV, 8.7%; BEV, 13.8%; P=0.21), and in-hospital death at the time of IE episode (SEV, 35.6%; BEV, 37.7%; P=0.74) were similar between groups. After a mean follow-up of 13±12 months, 59.1% and 54.6% of the SEV and BEV recipients, respectively, had died (P=0.66). CONCLUSIONS: The characteristics of IE post-TAVR, including microorganism type, vegetation location, and embolic complications but not early or late mortality, differed according to valve type. These results may help to guide the diagnosis and management of IE and inform future research studies in the field. (AU)

Impact of Preexisting Left Bundle Branch Block in Transcatheter Aortic Valve Replacement Recipients

BACKGROUND: The impact of preexisting left bundle branch block (LBBB) in transcatheter aortic valve replacement (TAVR) recipients is unknown. The aim of this study was to determine the impact of preexisting LBBB on clinical outcomes after TAVR. METHODS AND RESULTS: This multicenter study evaluated 3404 TAVR candidates according to the presence or absence of LBBB on baseline ECG. TAVR complications and causes of death were defined according to Valve Academic Research Consortium-2 definitions. Follow-up outpatient visits or telephone interviews were conducted at 30 days, 12 months, and yearly thereafter. Echocardiography examinations were performed at baseline, at hospital discharge, and at 1-year follow-up. Preexisting LBBB was present in 398 patients (11.7%) and was associated with an increased risk of permanent pacemaker implantation (PPI; 21.1% versus 14.8%; adjusted odds ratio, 1.51; 95% CI, 1.12­2.04) but not death (7.3% versus 5.5%; adjusted odds ratio, 1.33; 95% CI, 0.84­2.12) at 30 days. At a mean follow-up of 22±21 months, there were no differences between patients with and without preexisting LBBB in overall mortality (adjusted hazard ratio, 0.94; 95% CI, 0.75­1.18) and cardiovascular mortality (adjusted hazard ratio, 0.90; 95% CI, 0.68­1.21). In a subanalysis of 2421 patients without PPI at 30 days and with complete follow-up about the PPI, preexisting LBBB was not associated with an increased risk of PPI or sudden cardiac death. Patients with preexisting LBBB had a lower left ventricular ejection fraction (LVEF) at baseline and at 1-year follow-up (P <0.001 for both), but those with low LVEF exhibited a similar increase in LVEF over time after TAVR compared with patients with no preexisting LBBB (P=0.327). CONCLUSIONS: Preexisting LBBB significantly increased the risk of early (but not late) PPI after TAVR, without any significant effect on overall mortality or cardiovascular mortality. Preexisting LBBB was associated with lower LVEF pre-TAVR but did not prevent an increase in LVEF post-TAVR similar to patients without LBBB.

The Learning Curve and Annual Procedure Volume Standards for Optimum Outcomes of Transcatheter Aortic Valve Replacement: Findings From an International Registry

OBJECTIVES: The authors aimed to determine the procedural learning curve and minimum annual institutional volumes associated with optimum clinical outcomes for transcatheter aortic valve replacement (TAVR).BACKGROUND: Transcatheter aortic valve replacement (TAVR) is a complex procedure requiring significant training and experience for successful outcome. Despite increasing use of TAVR across institutions, limited information is available for its learning curve characteristics and minimum annual volumes required to optimize clinical outcomes. METHODS: The study collected data for patients at 16 centers participating in the international TAVR registry since initiation of the respective TAVR program. All cases were chronologically ordered into initial (1 to 75), early (76 to 150), intermediate (151 to 225), high (226 to 300), and very high (>300) experience operators for TAVR learning curve characterization. In addition, participating institutions were stratified by annual TAVR case volume into low-volume (<50), moderate-volume (50 to 100), and high-volume (>100) groups for comparative analysis. Procedural and 30-day clinical outcomes were collected and multivariate regression analysis performed for 30-day mortality and the early safety endpoint. RESULTS: A total of 3,403 patients comprised the study population. On multivariate analysis, all-cause mortality was significantly higher for initial (odds ratio [OR]: 3.83; 95% confidence interval [CI]: 1.93 to 7.60), early (OR: 2.41; 95%CI: 1.51 to 5.03), and intermediate (OR: 2.53; 95% CI: 1.19 to 5.40) experience groups compared with the very high experience operators. In addition, the early safety endpoint was significantly worse for all experience groups compared with the very high experience operators. Low annual volume (<50) TAVR institutions had significantly higher all-cause30-day mortality (OR: 2.70; 95% CI: 1.44 to 5.07) and worse early safety endpoint (OR: 1.60; 95% CI: 1.17 to 2.17) compared with the moderate- and high-volume groups. There was no difference in patient outcomes between intermediate and high annual volume groups. CONCLUSIONS: TAVR procedures display important learning curve characteristics with both greater procedural safety and a lower mortality when performed by experienced operators. In addition, TAVR performed at low annual volume (<50 procedures) institutions is associated with decreased procedural safety and higher patient mortality. These findings have important implications for operator training and patient care at centers performing TAVR.

Clinical impact of baseline right bundle branch block in patients undergoing transcatheter aortic valve replacement

This study sought to assess the influence of baseline right bundle branch block (RBBB) on all-cause and cardiovascular mortality as well as sudden cardiac death (SCD) among patients undergoing transcatheter aortic valve replacement (TAVR). Few data exist regarding the late clinical impact of pre-existing RBBB in TAVR recipients. A total of 3,527 patients (mean age 82 8 years, 50.1% men) were evaluated according to the presence of RBBB on baseline electrocardiography. Intraventricular conduction abnormalities were classified according to the American Heart Association, American College of Cardiology Foundation, and Heart Rhythm Society recommendations for standardization and interpretation of the electrocardiogram. TAVR complications and causes of death were defined according to Valve Academic Research Consortium 2 definitions. RBBB was present on baseline electrocardiography in 362 patients (10.3%) and associated with higher 30-day rates of permanent pacemaker implantation (PPI) (40.1% vs. 13.5%; p < 0.001) and death (10.2% vs. 6.9%; p » 0.024). At a mean follow-up of 20 18 months, pre-existing RBBB was independently associated with all-cause mortality (hazard ratio [HR]: 1.31; 95% confidence interval [CI]: 1.06 to 1.63; p » 0.014) and cardiovascular mortality (HR: 1.45; 95% CI: 1.11 to 1.89; p » 0.006) but not with SCD (HR: 0.71; 95% CI: 0.22 to 2.32; p » 0.57). Patients with pre-existing RBBB and without PPI at discharge from the index hospitalization had the highest 2-year risk for cardiovascular death (27.8%; 95% CI: 20.9% to 36.1%; log-rank p » 0.007). In a subanalysis of 1,245 patients without PPI at discharge from the index hospitalization and with complete follow-up regarding the need for PPI, pre-existing RBBB was independently associated with the composite of SCD and PPI (HR: 2.68; 95% CI: 1.16 to 6.17; p » 0.023)

Association between transcatheter aortic valve replacement and subsequent infective endocarditis and in-hospital death

IMPORTANCE: Limited data exist on clinical characteristics and outcomes of patients who had infective endocarditis after undergoing transcatheter aortic valve replacement (TAVR). OBJECTIVE: To determine the associated factors, clinical characteristics, and outcomes of patients who had infective endocarditis after TAVR. DESIGN, SETTING, AND PARTICIPANTS: The Infectious Endocarditis after TAVR International Registry included patients with definite infective endocarditis after TAVR from 47 centers from Europe, North America, and South America between June 2005 and October 2015. EXPOSURE: Transcatheter aortic valve replacement for incidence of infective endocarditis and infective endocarditis for in-hospital mortality. MAIN OUTCOMES AND MEASURES: Infective endocarditis and in-hospital mortality after infective endocarditis. RESULTS: A total of 250 cases of infective endocarditis occurred in 20 006 patients after TAVR (incidence, 1.1% per person-year; 95% CI, 1.1%-1.4%; median age, 80 years; 64% men). Median time from TAVR to infective endocarditis was 5.3 months (interquartile range [IQR], 1.5-13.4 months). The characteristics associated with higher risk of progressing to infective endocarditis after TAVR was younger age (78.9 years vs 81.8 years; hazard ratio [HR], 0.97 per year; 95% CI, 0.94-0.99), male sex (62.0% vs 49.7%; HR, 1.69; 95% CI, 1.13-2.52), diabetes mellitus (41.7% vs 30.0%; HR, 1.52; 95% CI, 1.02-2.29), and moderate to severe aortic regurgitation (22.4% vs 14.7%; HR, 2.05; 95% CI, 1.28-3.28). Health care-associated infective endocarditis was present in 52.8% (95% CI, 46.6%-59.0%) of patients...

Late cardiac death in patients undergoing transcatheter aortic valve replacement

BACKGROUND Little evidence exists of the burden and predictors of cardiac death after transcatheter aortic valvereplacement (TAVR).OBJECTIVES The purpose of this study was to assess the incidence and predictors of cardiac death from advancedheart failure (HF) and sudden cardiac death (SCD) in a large patient cohort undergoing TAVR.METHODS The study included a total of 3,726 patients who underwent TAVR using balloon (57%) or self-expandable(43%) valves. Causes of death were defined according to the Valve Academic Research Consortium–2.RESULTS At a mean follow-up of 22 18 months, 155 patients had died due to advanced HF (15.2% of total deaths,46.1% of deaths from cardiac causes) and 57 had died due to SCD (5.6% of deaths, 16.9% of cardiac deaths). Baselinecomorbidities (chronic obstructive pulmonary disease, atrial fibrillation, left ventricular ejection fraction #40%, lowermean transaortic gradient, pulmonary artery systolic pressure >60 mm Hg; p 160 ms had a greater SCD risk (HR: 4.78, 95% CI: 1.56 to 14.63; p » 0.006).CONCLUSIONS Advanced HF and SCD accounted for two-thirds of cardiac deaths in patients after TAVR.Potentially modifiable or treatable factors leading to increased risk of mortality for HF and SCD were identified. Future.

Obstrução coronária após implante de válvula aórtica por cateter para o tratamento de bioprótese valvular cirúrgica com disfunção: revisão sistemática da literatura / Coronary obstruction following transcatheter aortic valve implantation for degenerative bioprosthetic surgical valves: A systematic literature review

INTRODUÇÃO: Há poucos dados na literatura que avaliam a obstrução coronária após implante transcateter de válvula aórtica (TAVI, do inglês transcatheter aortic valve implantation) para o tratamento de disfunção de bioprótese aórtica (valve-in-valve - ViV). O presente estudo avaliou, por meio de revisão sistemática da literatura, as características clínicas, o manejo e os desfechos clínicos de pacientes com obstrução coronária após TAVI-ViV. MÉTODOS: Estudos publicados entre 2002 e 2013 avaliando a obstrução coronária como complicação de TAVI-ViV foram identificados por meio de busca eletrônica sistemática. Foram avaliados dados basais sobre as características clínicas e do procedimento, manejo da complicação e desfechos clínicos. RESULTADOS: Foram identificadas, no total, quatro publicações descrevendo sete pacientes. A maioria dos pacientes era do sexo feminino (71%), sendo a média de idade de 82 ± 5 anos, com STS-PROM de 9,4 ± 2,6%. As médias da altura do tronco da artéria coronária esquerda (TCE) e o diâmetro médio da raiz aórtica foram de 8,8 ± 1,5 mm e 28,0 ± 5,0 mm, respectivamente. A maioria dos pacientes apresentava biopróteses com suporte e folhetos montados externamente, ou eram próteses sem suporte (stentless) e o TCE foi envolvido em todos os casos. A intervenção coronária percutânea (ICP) foi tentada em todos os pacientes, tendo sucesso em quatro deles (57%). A mortalidade intra-hospitalar foi 42,9% (três casos), todos após ICP sem sucesso. CONCLUSÕES: A obstrução coronária após TAVI-ViV ocorreu mais frequentemente em mulheres com bioprótese com suporte e folheto montado externamente ou com bioprótese sem suporte. O TCE foi envolvido em todos os casos e a ICP foi realizada com sucesso em 60% deles. Esforços contínuos poderão auxiliar na detecção dos fatores associados a essa complicação, no intuito de se implementarem medidas apropriadas para sua prevenção.

BACKGROUND: Very few data exist on coronary obstruction following transcatheter aortic valve implantation (TAVI) for degenerative bioprosthetic valves (valve-in-valve - ViV). The present study evaluated, through a systematic review of the literature, the clinical characteristics, management and clinical outcomes of patients with coronary obstruction after ViV-TAVI. METHODS: Studies published between 2002 and 2013 evaluating coronary obstruction as a complication of ViV-TAVI were identified using a systematic electronic search. Data on the clinical and procedural characteristics, management of the complication, and clinical outcomes were analyzed. RESULTS: A total of four publications describing seven patients were identified. Most patients (71%) were women, with mean age of 82 ± 5 years, and STS-PROM score of 9.4 ± 2.6%. Mean left coronary artery (LCA) ostium height and aortic root width were 8.8 ± 1.5 mm and 28.0 ± 5.0 mm, respectively. Most patients had stented bioprosthetic valves with externally mounted leaflets or stentless aortic bioprosthesis, and the LCA was involved in all patients. Percutaneous coronary intervention (PCI) was attempted in all patients and was successful in four (57%). In-hospital mortality was 42.9% (three cases), all of them after failed PCI. CONCLUSIONS: Coronary obstruction following ViV-TAVI occurred more frequently in women with stented bioprosthetic valves with externally mounted leaflets or with stentless bioprosthesis. The LCA was involved in all cases and PCI was successful in 60% of them. Continued efforts may help identify the factors associated with this complication so that appropriate prevention measures may be implemented.