RESUMEN
BACKGROUND: Paravalvular regurgitation (PVR) is a common complication after transcatheter aortic valve replacement, posing an increased risk of heart failure and mortality. Accurate intraprocedural quantification of PVR is challenging. Both hemodynamic indices and videodensitometry can be used for intraprocedural assessment of PVR. We compared the predictive value of the isolated versus combined use of the hemodynamic index diastolic delta (DD) and videodensitometry for the incidence of relevant PVR 1 month after transcatheter aortic valve replacement. METHODS AND RESULTS: In this prospective cohort study, patients underwent periprocedural PVR assessment by DD and videodensitometry (using left ventricular outflow tract-aortic regurgitation [LVOT-AR]). Cardiac magnetic resonance served as reference modality for PVR assessment. Relevant PVR was defined as cardiac magnetic resonance-regurgitant fraction >20%. Fifty-one patients were enrolled in this study. Mean age was 80.6±5.2 years and 45.1% of patients were men. Mean LVOT-AR and cardiac magnetic resonance-regurgitant fraction were 8.2%±7.8% and 11.7%±9.6%, respectively. The correlation between DD and LVOT-AR was weak (r=-0.36). DD and LVOT-AR showed a comparable accuracy to predict relevant PVR (area under the curve 0.82, 95% CI: 0.69-0.95 versus area area under the time-density curve 0.80, 95% CI: 0.62-0.99). The combination of DD and LVOT-AR improved the prediction of relevant PVR (area under the time-density curve, 0.90, 95% CI: 0.81-0.99), and resulted in an increased concordance (86.3%) and positive predictive value (75%) compared with DD alone (76.5% and 40%, respectively), or LVOT-AR alone (82.3% and 50%, respectively). CONCLUSIONS: DD and videodensitometry are both accurate and feasible modalities for the assessment of PVR after transcatheter aortic valve replacement. The synergistic use of both techniques increases the predictive value for relevant PVR after transcatheter aortic valve replacement. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04281771.
Asunto(s)
Insuficiencia de la Válvula Aórtica , Valor Predictivo de las Pruebas , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Masculino , Femenino , Insuficiencia de la Válvula Aórtica/etiología , Insuficiencia de la Válvula Aórtica/fisiopatología , Insuficiencia de la Válvula Aórtica/diagnóstico , Insuficiencia de la Válvula Aórtica/diagnóstico por imagen , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Estudios Prospectivos , Anciano de 80 o más Años , Anciano , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/fisiopatología , Válvula Aórtica/cirugía , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/fisiopatología , Hemodinámica/fisiología , Diástole , Resultado del Tratamiento , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/diagnósticoAsunto(s)
Puente de Arteria Coronaria , Enfermedad de la Arteria Coronaria , Intervención Coronaria Percutánea , Humanos , Intervención Coronaria Percutánea/métodos , Enfermedad de la Arteria Coronaria/cirugía , Enfermedad de la Arteria Coronaria/terapia , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Puente de Arteria Coronaria/métodos , Angiografía Coronaria , Toma de Decisiones Clínicas , Resultado del Tratamiento , Índice de Severidad de la Enfermedad , Reserva del Flujo Fraccional MiocárdicoRESUMEN
Intravascular ultrasound and optical coherence tomography are used with increasing frequency for the care of coronary patients and in research studies. These imaging tools can identify culprit lesions in acute coronary syndromes, assess coronary stenosis severity, guide percutaneous coronary intervention (PCI), and detect vulnerable plaques and patients. However, they have significant limitations that have stimulated the development of multimodality intracoronary imaging catheters, which provide improvements in assessing vessel wall pathology and guiding PCI. Prototypes combining 2 or even 3 imaging probes with complementary attributes have been developed, and several multimodality systems have already been used in patients, with near-infrared spectroscopy intravascular ultrasound-based studies showing promising results for the identification of high-risk plaques. Moreover, postmortem histology studies have documented that hybrid imaging catheters can enable more accurate characterization of plaque morphology than standalone imaging. This review describes the evolution in the field of hybrid intracoronary imaging; presents the available multimodality catheters; and discusses their potential role in PCI guidance, vulnerable plaque detection, and the assessment of endovascular devices and emerging pharmacotherapies targeting atherosclerosis.
Asunto(s)
Enfermedad de la Arteria Coronaria , Vasos Coronarios , Imagen Multimodal , Intervención Coronaria Percutánea , Placa Aterosclerótica , Valor Predictivo de las Pruebas , Tomografía de Coherencia Óptica , Ultrasonografía Intervencional , Humanos , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/terapia , Vasos Coronarios/diagnóstico por imagen , Vasos Coronarios/patología , Intervención Coronaria Percutánea/instrumentación , Diseño de Equipo , Catéteres Cardíacos , Difusión de Innovaciones , Cateterismo Cardíaco/instrumentación , Espectroscopía Infrarroja Corta , AnimalesRESUMEN
BACKGROUND: The long-term impact of drug-coated balloon (DCB) angioplasty for the treatment of patients with de novo coronary artery lesions remains uncertain. We aimed to assess the non-inferiority of DCB angioplasty with rescue stenting to intended drug-eluting stent (DES) deployment for patients with de novo, non-complex coronary artery lesions. METHODS: REC-CAGEFREE I was an open-label, randomised, non-inferiority trial conducted at 43 sites in China. After successful lesion pre-dilatation, patients aged 18 years or older with de novo, non-complex coronary artery disease (irrespective of target vessel diameter) and an indication for percutaneous coronary intervention were randomly assigned (1:1), via a web-based centralised system with block randomisation (block size of two, four, or six) and stratified by site, to paclitaxel-coated balloon angioplasty with the option of rescue stenting due to an unsatisfactory result (DCB group) or intended deployment of second-generation thin-strut sirolimus-eluting stents (DES group). The primary outcome was the device-oriented composite endpoint (DoCE; including cardiovascular death, target vessel myocardial infarction, and clinically and physiologically indicated target lesion revascularisation) assessed at 24 months in the intention-to-treat (ITT) population (ie, all participants randomly assigned to treatment). Non-inferiority was established if the upper limit of the one-sided 95% CI for the absolute risk difference was smaller than 2·68%. Safety was assessed in the ITT population. This study is registered with ClinicalTrials.gov, NCT04561739. It is closed to accrual and extended follow-up is ongoing. FINDINGS: Between Feb 5, 2021, and May 1, 2022, 2272 patients were randomly assigned to the DCB group (1133 [50%]) or the DES group (1139 [50%]). Median age at the time of randomisation was 62 years (IQR 54-69), 1574 (69·3%) of 2272 were male, 698 (30·7%) were female, and all patients were of Chinese ethnicity. 106 (9·4%) of 1133 patients in the DCB group received rescue DES after unsatisfactory DCB angioplasty. As of data cutoff (May 1, 2024), median follow-up was 734 days (IQR 731-739). At 24 months, the DoCE occurred in 72 (6·4%) of 1133 patients in the DCB group and 38 (3·4%) of 1139 in the DES group, with a risk difference of 3·04% in the cumulative event rate (upper boundary of the one-sided 95% CI 4·52; pnon-inferiority=0·65; two-sided 95% CI 1·27-4·81; p=0·0008); the criterion for non-inferiority was not met. During intervention, no acute vessel closures occurred in the DCB group and one (0·1%) of 1139 patients in the DES group had acute vessel closure. Periprocedural myocardial infarction occurred in ten (0·9%) of 1133 patients in the DCB group and nine (0·8%) in the DES group. INTERPRETATION: In patients with de novo, non-complex coronary artery disease, irrespective of vessel diameter, a strategy of DCB angioplasty with rescue stenting did not achieve non-inferiority compared with the intended DES implantation in terms of the DoCE at 2 years, which indicates that DES should remain the preferred treatment for this patient population. FUNDING: Xijing Hospital and Shenqi Medical. TRANSLATION: For the Chinese translation of the abstract see Supplementary Materials section.
Asunto(s)
Angioplastia Coronaria con Balón , Enfermedad de la Arteria Coronaria , Stents Liberadores de Fármacos , Paclitaxel , Humanos , Masculino , Femenino , Persona de Mediana Edad , Angioplastia Coronaria con Balón/métodos , Paclitaxel/administración & dosificación , Paclitaxel/uso terapéutico , Enfermedad de la Arteria Coronaria/terapia , Anciano , Sirolimus/uso terapéutico , Sirolimus/administración & dosificación , Resultado del Tratamiento , Materiales Biocompatibles Revestidos , China/epidemiología , Intervención Coronaria Percutánea/métodosRESUMEN
BACKGROUND: The relationship between long-term outcomes and operator experience for left atrial appendage occlusion (LAAO) is still unknown. OBJECTIVES: This study sought to explore the association between operator LAAO experience and one-year clinical outcomes. METHODS: The RECORD study (Registry to Evaluate Chinese Real-World Clinical Outcomes in Patients With AF Using the WATCHMAN Left Atrial Appendage Closure Technology; NCT03917563) was a multicenter, prospective registry that included patients with the WATCHMAN LAAO device (Boston Scientific) in China from April 1, 2019, to October 31, 2020. The current analyses included patients with solely LAAO from the registry; those who had concomitant LAAO and ablation/other procedures were excluded. The primary outcome was a composite endpoint of death, stroke, systemic embolism, and Bleeding Academic Research Consortium (BARC)-defined type 3 or 5 bleeding at 1 year. RESULTS: A total of 1,547 LAAO patients and 111 operators were included. The mean ± SD CHA2DS2-VASc and HAS-BLED scores of patients were 4.0 ± 1.8 and 2.5 ± 1.1, respectively. The mean ± SD age of operators was 47.0 ± 7.2 years, 15 (13.5%) were female, and 52 (46.8%) were electrophysiologists. Utilizing maximally selected log-rank statistics, the thresholds to categorize an experienced operator were performing ≥32 LAAOs annually or ≥134 LAAOs in total. Performing ≥32 LAAOs annually is the better criterion than ≥134 LAAOs in total (absolute net reclassification index: 25.79%; P < 0.001). Compared with the ≥32 LAAO annually group, the <32 group was associated with a 1.8-fold (HRadjusted: 1.79; 95% CI: 1.16-2.78; P = 0.009) increase in the risk of the primary endpoint, and such risk in the <32 group can be reduced by â¼12% after performing each additional 5 cases (HRadjusted per 5 cases: 0.88; 95% CI: 0.78-0.99; P = 0.033). CONCLUSIONS: Performing ≥32 LAAOs annually could be a threshold to categorize an experienced operator. Before reaching this threshold, the risk of death, stroke, systemic embolism, and BARC-defined type 3 or 5 bleeding decreased by 12% after every 5 cases performed.
Asunto(s)
Angiografía Coronaria , Valor Predictivo de las Pruebas , Humanos , Reproducibilidad de los Resultados , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/terapia , Índice de Severidad de la Enfermedad , Circulación Coronaria , Vasos Coronarios/diagnóstico por imagen , Reserva del Flujo Fraccional Miocárdico , PronósticoRESUMEN
OBJECTIVES: This study aimed to investigate the impact of calcific (Ca) on the efficacy of coronary computed coronary angiography (CTA) in evaluating plaque burden (PB) and composition with near-infrared spectroscopy-intravascular ultrasound (NIRS-IVUS) serving as the reference standard. MATERIALS AND METHODS: Sixty-four patients (186 vessels) were recruited and underwent CTA and 3-vessel NIRS-IVUS imaging (NCT03556644). Expert analysts matched and annotated NIRS-IVUS and CTA frames, identifying lumen and vessel wall borders. Tissue distribution was estimated using NIRS chemograms and the arc of Ca on IVUS, while in CTA Hounsfield unit cut-offs were utilized to establish plaque composition. Plaque distribution plots were compared at segment-, lesion-, and cross-sectional-levels. RESULTS: Segment- and lesion-level analysis showed no effect of Ca on the correlation of NIRS-IVUS and CTA estimations. However, at the cross-sectional level, Ca influenced the agreement between NIRS-IVUS and CTA for the lipid and Ca components (p-heterogeneity < 0.001). Proportional odds model analysis revealed that Ca had an impact on the per cent atheroma volume quantification on CTA compared to NIRS-IVUS at the segment level (p-interaction < 0.001). At lesion level, Ca affected differences between the modalities for maximum PB, remodelling index, and Ca burden (p-interaction < 0.001, 0.029, and 0.002, respectively). Cross-sectional-level modelling demonstrated Ca's effect on differences between modalities for all studied variables (p-interaction ≤ 0.002). CONCLUSION: Ca burden influences agreement between NIRS-IVUS and CTA at the cross-sectional level and causes discrepancies between the predictions for per cent atheroma volume at the segment level and maximum PB, remodelling index, and Ca burden at lesion-level analysis. CLINICAL RELEVANCE STATEMENT: Coronary calcification affects the quantification of lumen and plaque dimensions and the characterization of plaque composition coronary CTA. This should be considered in the analysis and interpretation of CTAs performed in patients with extensive Ca burden. KEY POINTS: Coronary CT Angiography is limited in assessing coronary plaques by resolution and blooming artefacts. Agreement between dual-source CT angiography and NIRS-IVUS is affected by a Ca burden for the per cent atheroma volume. Advanced CT imaging systems that eliminate blooming artefacts enable more accurate quantification of coronary artery disease and characterisation of plaque morphology.
RESUMEN
Background: Coronary artery calcium score (CACS) is an established marker of coronary artery disease (CAD) and has been extensively used to stratify risk in asymptomatic individuals. However, the value of CACS in predicting plaque morphology in patients with advanced CAD is less established. The present analysis aims to assess the association between CACS and plaque characteristics detected by near-infrared spectroscopy-intravascular ultrasound (NIRS-IVUS) imaging in patients with obstructive CAD. Methods: Seventy patients with obstructive CAD underwent coronary computed tomography angiography (CTA) and 3-vessel NIRS-IVUS imaging were included in the present analysis. The CTA data were used to measure the CACS in the entire coronary tree and the segments assessed by NIRS-IVUS, and these estimations were associated with the NIRS-IVUS measurements at a patient and segment level. Results: In total, 65 patients (188 segments) completed the study protocol and were included in the analysis. A weak correlation was noted between the CACS, percent atheroma volume (r = 0.271, P = .002), and the calcific burden measured by NIRS-IVUS (r = 0.648, P < .001) at patient-level analysis. Conversely, there was no association between the CACS and the lipid content, or the incidence of high-risk plaques detected by NIRS. Linear regression analysis at the segment level demonstrated an association between the CACS and the total atheroma volume (coefficient, 0.087; 95% CI, 0.024-0.149; P = .008) and the calcific burden (coefficient, 0.117; 95% CI, 0.048-0.186; P = .001), but there was no association between the lipid content or the incidence of high-risk lesions. Conclusions: In patients with obstructive CAD, the CACS is not associated with the lipid content or plaque phenotypes. These findings indicate that the CACS may have a limited value for screening or stratifying cardiovascular risk in symptomatic patients with a high probability of CAD.
RESUMEN
INTRODUCTION: The higher scaffold thrombosis rates observed with the first-generation bioresorbable scaffolds (BRSs) compared to conventional drug-eluting stents were likely due in part to bioresorbable polymers having insufficient radial strength, necessitating larger strut profiles. Meta-analysis of the long-term outcomes from the first-generation Absorb bioresorbable vascular scaffold (BVS) showed that this period of excess risk ended at 3 years. Therefore, current attention has been focused on improving early outcomes by increasing the scaffold's tensile strength and reducing strut thickness. AREAS COVERED: This review summaries the lessons learned from the first-generation BRS. It updates the long-term clinical outcomes of trials evaluating the ABSORB BVS and metallic alloy-based BRS. In addition, it reviews the next-generation BRSs manufactured in Asia. EXPERT OPINION: Critical areas to improve the performance and safety of biodegradable scaffolds include further development in material science, surface modification, delivery systems, and long-term follow-up studies.
Asunto(s)
Implantes Absorbibles , Diseño de Prótesis , Andamios del Tejido , Humanos , Factores de Tiempo , Stents Liberadores de Fármacos/efectos adversos , Resistencia a la Tracción , Enfermedad de la Arteria Coronaria/terapia , Enfermedad de la Arteria Coronaria/cirugía , Polímeros , Intervención Coronaria Percutánea/métodos , Intervención Coronaria Percutánea/efectos adversos , AnimalesRESUMEN
BACKGROUND: Coronary artery lumen volume (V) to myocardial mass (M) ratio (V/M) can show the mismatch between epicardial coronary arteries and the underlying myocardium. METHODS: The V, M and V/M were obtained from the coronary computed tomography angiography (CCTA) of patients in the FAST-TRACK CABG study, the first-in-human trial of coronary artery bypass grafting (CABG) guided solely by CCTA and fractional flow reserve derived from CCTA (FFRCT) in patients with complex coronary artery disease (CAD). The correlations between V/M ratios and baseline characteristics were determined and compared with those from the ADVANCE registry, an unselected cohort of historical controls with chronic CAD. RESULTS: The V/M ratio was obtained in 106 of the 114 pre-CABG CCTAs. Mean age was 65.6 years and 87% of them were male. The anatomical SYNTAX score from CCTA was significantly higher than the functional SYNTAX score derived using FFRCT [43.1 (15.2) vs 41.1 (16.5), p â< â0.001]. Mean V, M, and V/M were 2204 âmm3, 137 âg, and 16.5 âmm3/g, respectively. There were weak negative correlations between V and anatomical and functional SYNTAX scores (Pearson's r â= â-0.26 and -0.34). V and V/M had a strong correlation (r â= â0.82). The V/M ratio in the current study was significantly lower than that in the ADVANCE registry (median 16.1 vs. 24.8 [1st quartile 20.1]). CONCLUSION: Systematically smaller V/M ratios were found in this population with severe CAD requiring CABG compared to an unselected cohort with chronic CAD. The V/M ratio could provide additional non-invasive assessment of CAD especially when combined with FFRCT.
Asunto(s)
Angiografía por Tomografía Computarizada , Angiografía Coronaria , Puente de Arteria Coronaria , Enfermedad de la Arteria Coronaria , Vasos Coronarios , Reserva del Flujo Fraccional Miocárdico , Valor Predictivo de las Pruebas , Sistema de Registros , Índice de Severidad de la Enfermedad , Humanos , Masculino , Femenino , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/fisiopatología , Anciano , Persona de Mediana Edad , Vasos Coronarios/diagnóstico por imagen , Vasos Coronarios/fisiopatología , Reproducibilidad de los Resultados , Tomografía Computarizada MultidetectorRESUMEN
INTRODUCTION: The baseline characteristics affecting mortality following percutaneous or surgical revascularization in patients with left main and / or 3vessel coronary artery disease (CAD) observed in realworld practice differ from those established in randomized controlled trials (RCTs) due to the constraints of inclusion / exclusion criteria. OBJECTIVES: This study aimed to assess whether systematic screening enables identification of novel and registryspecific baseline patient characteristics influencing longterm mortality. PATIENT AND METHODS: Least absolute shrinkage and selection operator (LASSO) regression was used to screen 42 baseline patient characteristics shared by the SYNTAX (Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery) trial and a singlecenter Polish registry of 1035 consecutive patients with complex CAD who received revascularization and were followed-up for 5 years. After screening, a classic Cox regression analysis was performed to examine the suitability of a linear model for predicting 5year mortality, which was then compared with the mortality predicted in the same cohort using the SYNTAX score II 2020 (SS2020). RESULTS: The 5year mortality rate in the registry was 12.3%, and the strongest predictors were pulmonary hypertension, chronic obstructive pulmonary disease, and insulindependent diabetes. In an internal validation, the linear model constructed after LASSO screening and combined with a classic Cox regression analysis improved the prediction of 5year mortality, as compared with the SS2020 (concordance index of 0.92 and 0.75, respectively). CONCLUSIONS: A machine learning approach improved the detection of registryspecific risk factors in allcomer patients amenable to surgical or percutaneous revascularization who were evaluated by a heart team. The risk factors identified in RCTs are not necessarily the same as those detected in real clinical practice when systematic screening is applied.
Asunto(s)
Enfermedad de la Arteria Coronaria , Aprendizaje Automático , Intervención Coronaria Percutánea , Humanos , Enfermedad de la Arteria Coronaria/cirugía , Enfermedad de la Arteria Coronaria/mortalidad , Masculino , Femenino , Anciano , Persona de Mediana Edad , Factores de Riesgo , Sistema de Registros , Revascularización Miocárdica , PoloniaRESUMEN
BACKGROUNDS: The impact of quantitative assessment to differentiate total occlusions (TOs) from severe stenoses on coronary computed tomography angiography (CCTA) remains unknown. OBJECTIVE: This study investigated whether quantitative characteristics assessed on CCTA could help differentiate a TO from a severe stenosis on invasive coronary angiography (ICA). METHODS: This study is a sub-analysis of the FASTTRACK CABG (NCT04142021) in which both CCTA and ICA were routinely performed. Quantitative analysis was performed with semi-automated CCTA plaque-analysis software. Blinded analysts compared TOs on CCTA, defined as a complete lack of contrast opaciï¬cation within the coronary occlusion, with corresponding ICA. RESULTS: Eighty-four TOs were seen on CCTA in 59 of the 114 patients enrolled in the trial. The concordance in diagnosing a TO between ICA and CCTA was 56.0% (n â= â47). Compared to severe stenoses, TOs had a significantly longer lesion length (25.1 â± â23.0 âmm vs 9.4 â± â11.2 âmm, P â< â0.001). The best cut-off value to differentiate a TO from severe stenosis was a lesion length of 5.5 âmm (area under the curve 0.77, 95% CI: 0.66-0.87), with a 91.1% sensitivity and 61.1% specificity. Dense calcium percentage atheroma volume (PAV) was significantly higher in TOs compared to severe stenoses (18.7 â± â19.6% vs. 6.6 â± â13.0%, P â< â0.001), whilst the opposite was seen for fibro-fatty PAV (31.3 â± â14.2% vs. 19.5 â± â10.5%, P â< â0.001). On a multivariable logistic regression analysis, lesion length (>5.5 âmm) was the only parameter associated with differentiating a TO from a severe stenosis. CONCLUSION: In quantitative CCTA analysis, a lesion length >5.5 âmm was the only independent predictor differentiating a TO from a severe stenosis. NCT REGISTRATION NUMBER: NCT04142021.
Asunto(s)
Angiografía por Tomografía Computarizada , Angiografía Coronaria , Oclusión Coronaria , Estenosis Coronaria , Vasos Coronarios , Placa Aterosclerótica , Valor Predictivo de las Pruebas , Índice de Severidad de la Enfermedad , Humanos , Estenosis Coronaria/diagnóstico por imagen , Masculino , Femenino , Persona de Mediana Edad , Anciano , Diagnóstico Diferencial , Vasos Coronarios/diagnóstico por imagen , Oclusión Coronaria/diagnóstico por imagen , Reproducibilidad de los Resultados , Tomografía Computarizada Multidetector , Interpretación de Imagen Radiográfica Asistida por ComputadorRESUMEN
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 1â¢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 10â¢44% and assuming an event rate of 26â¢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 80â¢0 years (SD 5â¢7) for those treated with the Myval THV and 80â¢4 years (5â¢4) for those treated with a contemporary THV. Median Society of Thoracic Surgeons scores were the same in both groups (Myval 2â¢6% [IQR 1â¢74â¢0] vs contemporary 2â¢6% [1â¢74â¢0]). The primary endpoint showed non-inferiority of the Myval (25%) compared with contemporary THV (27%), with a risk difference of 2â¢3% (one-sided upper 95% CI 3â¢8, pnon-inferiority<0â¢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.
RESUMEN
Inferior outcomes with ACURATE neo, a self-expanding transcatheter heart valve (THV) for the treatment of severe aortic stenosis, were mainly driven by higher rates of moderate/severe paravalvular leak (PVL). To overcome this limitation, the next-generation ACURATE neo2 features a 60% larger external sealing skirt. Data on long-term performance are limited; however, clinical evidence suggests improved short-term performance which is comparable to contemporary THVs. This report reviews data on short-term clinical and echocardiographic outcomes of ACURATE neo2. A PubMed search yielded 13 studies, including 5 single arm and 8 nonrandomized comparative studies with other THVs which reported in-hospital or 30-day clinical and echocardiographic outcomes. In-hospital or 30-day all-cause mortality was ≤3.3%, which is comparable to other contemporary THVs. The rates of postprocedural â§moderate PVL ranged 0.6%-4.7%. In multicenter propensity-matched analyses, neo2 significantly reduced the rate of â§moderate PVL compared to neo (3.5% vs. 11.3%, p < 0.01), whereas rates were comparable to Evolut Pro/Pro+ (Neo2: 2.0% vs. Pro/Pro+: 3.1%, p = 0.28) and SAPIEN 3 Ultra (Neo2: 0.6% vs. Ultra: 1.1%, p = 0.72). The rate of permanent pacemaker implantation with neo2 was consistently low (3.3%-8.6%) except in one study, and in propensity-matched analyses were significantly lower than Evolut Pro/Pro+ (6.7% vs. 16.7%, p < 0.01), and comparable to SAPIEN 3 Ultra (8.1% vs. 10.3%, p = 0.29). In conclusion, ACURATE neo2 showed better short-term performance by considerably reducing PVL compared to its predecessor, with short-term clinical and echocardiographic outcomes comparable to contemporary THVs.
RESUMEN
BACKGROUND: There are different definitions of periprocedural myocardial infarction (PPMI) both in terms of thresholds for cardiac biomarkers and the ancillary criteria for myocardial ischemia. Cardiac Troponin I (cTnI) and cardiac Troponin T (cTnT) are used interchangeably to diagnose PPMI. OBJECTIVES: This study evaluated the frequency of periprocedural myocardial injury and infarction as defined by the Society of Cardiovascular Angiography & Interventions (SCAI), the Academic Research Consortium-2 (ARC-2), and the 4th Universal definition of MI (4UDMI) stratified using cTnT versus cTnI, among patients with chronic coronary syndrome (CCS) and unstable angina. RESULTS: Among 830 patients, PPMI rates according to the SCAI, ARC2 and 4UDMI criteria were 4.34 %, 2.05 %, and 4.94 % respectively, with higher rates seen for all definitions when using cTnI versus cTnT (SCAI: 9.84 % vs. 1.91 %, p < 0.001; ARC 2: 3.15 % vs. 1.56 %, p = 0.136; and 4UDMI 5.91 % vs. 4.51 %, p = 0.391). Minor and major periprocedural myocardial injury was respectively observed in 58.31 % and 27.10 % of patients, with rates of both significantly higher when using cTnI versus cTnT (Minor: 69.29 % vs. 53.47 %, p < 0.001, Major: 49.21 % vs. 17.36 %, p < 0.001). CONCLUSIONS: Among patients with CCS and unstable angina, PPMIs defined by SCAI occurred more frequently when using cTnI as opposed to cTnT, whereas the type of troponin had no impact on the incidence of PPMIs according to the ARC-2 and 4UDMI.
RESUMEN
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 2-4), 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 1·7-4·0] vs contemporary 2·6% [1·7-4·0]). 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. FUNDING: Meril Life Sciences.
Asunto(s)
Estenosis de la Válvula Aórtica , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/cirugía , Complicaciones Posoperatorias/epidemiología , Estudios Prospectivos , Diseño de Prótesis , Índice de Severidad de la Enfermedad , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Resultado del TratamientoRESUMEN
BACKGROUND: Microvascular resistance reserve (MRR) can characterize coronary microvascular dysfunction (CMD); however, its prognostic impact in ST-segment elevation myocardial infarction (STEMI) patients remains undefined. OBJECTIVES: This study sought to investigate the prevalence of CMD in STEMI patients and to elucidate the prognostic performance of MRR. METHODS: This prospective cohort study enrolled 210 STEMI patients with multivessel disease who underwent successful revascularization and returned at 3 months for coronary physiology assessments with bolus thermodilution. The prevalence of CMD (MRR <3) and the association between MRR and major adverse cardiovascular and cerebrovascular events (MACCEs) at 12 months were investigated. RESULTS: The median age of patients was 65 years, and 59.5% were men. At the 3-month follow-up, 56 patients (27%) had CMD (MRR <3.0). The number of MACCEs at 12 months was higher in patients with vs without CMD (48.2% vs 11.0%; P < 0.001). MRR was independently associated with 12-month MACCEs (HR: 0.45 per unit increase; 95% CI: 0.31-0.67; P < 0.001) and with stroke, heart failure, and poorer recovery in left ventricular systolic function. The areas under the receiver-operating characteristic curves for predicting MACCEs at 12 months with fractional flow reserve, coronary flow reserve (CFR), the index of microvascular resistance (IMR), and MRR were 0.609, 0.762, 0.781, and 0.743, respectively. The prognostic performance of CFR, IMR, and MRR were all comparable. CONCLUSIONS: The novel parameter MRR is a prognostic marker of MACCEs in STEMI patients with a comparable performance to CFR and IMR. (Impact of TMAO Serum Levels on Hyperemic IMR in STEMI Patients [TAMIR]; NCT05406297).
Asunto(s)
Enfermedad de la Arteria Coronaria , Circulación Coronaria , Microcirculación , Intervención Coronaria Percutánea , Valor Predictivo de las Pruebas , Infarto del Miocardio con Elevación del ST , Termodilución , Resistencia Vascular , Humanos , Masculino , Infarto del Miocardio con Elevación del ST/fisiopatología , Infarto del Miocardio con Elevación del ST/terapia , Infarto del Miocardio con Elevación del ST/mortalidad , Infarto del Miocardio con Elevación del ST/diagnóstico , Femenino , Estudios Prospectivos , Anciano , Persona de Mediana Edad , Resultado del Tratamiento , Factores de Tiempo , Factores de Riesgo , Intervención Coronaria Percutánea/efectos adversos , Enfermedad de la Arteria Coronaria/fisiopatología , Enfermedad de la Arteria Coronaria/terapia , Enfermedad de la Arteria Coronaria/mortalidad , Enfermedad de la Arteria Coronaria/diagnóstico , Prevalencia , Vasos Coronarios/fisiopatología , Vasos Coronarios/diagnóstico por imagen , Medición de RiesgoRESUMEN
The 2023 European Bifurcation Club (EBC) meeting took place in Warsaw in October, and the latest evidence for the use of intravascular ultrasound (IVUS) and optical coherence tomography (OCT) to optimise percutaneous coronary interventions (PCI) on coronary bifurcation lesions (CBLs) was a major focus. The topic generated deep discussions and general appraisal on the potential benefits of IVUS and OCT in PCI procedures. Nevertheless, despite an increasing recognition of IVUS and OCT capabilities and their recognised central role for guidance in complex CBL and left main PCI, it is expected that angiography will continue to be the primary guidance modality for CBL PCI, principally due to educational and economic barriers. Mindful of the restricted access/adoption of intracoronary imaging for CBL PCI, the EBC board decided to review and describe a series of tips and tricks which can help to optimise angiography-guided PCI for CBLs. The identified key points for achieving an optimal angiography-guided PCI include a thorough analysis of pre-PCI images (computed tomography angiography, multiple angiographic views, quantitative coronary angiography vessel estimation), a systematic application of the technical steps suggested for a given selected technique, an intraprocedural or post-PCI use of stent enhancement and a low threshold for bailout use of intravascular imaging.
Asunto(s)
Consenso , Angiografía Coronaria , Enfermedad de la Arteria Coronaria , Intervención Coronaria Percutánea , Tomografía de Coherencia Óptica , Ultrasonografía Intervencional , Humanos , Intervención Coronaria Percutánea/métodos , Angiografía Coronaria/métodos , Ultrasonografía Intervencional/métodos , Ultrasonografía Intervencional/normas , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/terapia , Tomografía de Coherencia Óptica/métodos , Vasos Coronarios/diagnóstico por imagen , Vasos Coronarios/cirugíaRESUMEN
Evidence regarding the comparative efficacy of the different methods to determine the significance of coronary stenoses in the catheterization laboratory is lacking. We aimed to compare all available methods guiding the decision to perform percutaneous coronary intervention (PCI). We searched Medline, Embase, and CENTRAL until October 5, 2023. We included trials that randomized patients with greater than 30% stenoses who were considered for PCI and reported major adverse cardiovascular events (MACE). We performed a frequentist random-effects network meta-analysis and assessed the certainty of evidence using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. We included 15 trials with 16,333 participants with a mean weighted follow-up of 34 months. The trials contained a median of 49.3% (interquartile range: 32.6%, 100%) acute coronary syndrome participants. Quantitative flow ratio (QFR) was associated with a decreased risk of MACE compared with coronary angiography (CA) (risk ratio [RR] 0.68, 95% confidence interval [CI] 0.56 to 0.82, high certainty), fractional flow reserve (FFR) (RR 0.73, 95% CI 0.58 to 0.92, moderate certainty), and instantaneous wave-free ratio (iFR) (RR 0.63, 95% CI 0.49 to 0.82, moderate certainty), and ranked first for MACE (88.1% probability of being the best). FFR (RR 0.93, 95% CI 0.82 to 1.06, moderate certainty) and iFR (RR 1.07, 95% CI 0.90 to 1.28, moderate certainty) likely did not decrease the risk of MACE compared with CA. Intravascular imaging may not be associated with a significant decrease in MACE compared with CA (RR 0.85, 95% CI 0.62 to 1.17, low certainty) when used to guide the decision to perform PCI. In conclusion, a decision to perform PCI based on QFR was associated with a decreased risk of MACE compared with CA, FFR, and iFR in a mixed stable coronary disease and acute coronary syndrome population. These hypothesis-generating findings should be validated in large, randomized, head-to-head trials.
Asunto(s)
Angiografía Coronaria , Estenosis Coronaria , Reserva del Flujo Fraccional Miocárdico , Metaanálisis en Red , Intervención Coronaria Percutánea , Ensayos Clínicos Controlados Aleatorios como Asunto , Humanos , Síndrome Coronario Agudo/terapia , Síndrome Coronario Agudo/cirugía , Estenosis Coronaria/cirugía , Estenosis Coronaria/fisiopatología , Reserva del Flujo Fraccional Miocárdico/fisiología , Intervención Coronaria Percutánea/métodosRESUMEN
Iatrogenic aortic dissection is a rare but life-threatening complication of coronary artery bypass surgery. We report a case with incidentally detected iatrogenic aortic dissection related to aorta cross-clamping that was successfully managed with watchful follow-up. The decision making was based on 3-dimensional holographic and fluid dynamic analysis guidance.