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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.
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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.
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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.
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Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/cirurgia , Complicações Pós-Operatórias/epidemiologia , Estudos Prospectivos , Desenho de Prótese , Índice de Gravidade de Doença , Substituição da Valva Aórtica Transcateter/métodos , Resultado do TratamentoRESUMO
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.
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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.
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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.
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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).
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Doença da Artéria Coronariana , Circulação Coronária , Microcirculação , Intervenção Coronária Percutânea , Valor Preditivo dos Testes , Infarto do Miocárdio com Supradesnível do Segmento ST , Termodiluição , Resistência Vascular , Humanos , Masculino , Infarto do Miocárdio com Supradesnível do Segmento ST/fisiopatologia , Infarto do Miocárdio com Supradesnível do Segmento ST/terapia , Infarto do Miocárdio com Supradesnível do Segmento ST/mortalidade , Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico , Feminino , Estudos Prospectivos , Idoso , Pessoa de Meia-Idade , Resultado do Tratamento , Fatores de Tempo , Fatores de Risco , Intervenção Coronária Percutânea/efeitos adversos , Doença da Artéria Coronariana/fisiopatologia , Doença da Artéria Coronariana/terapia , Doença da Artéria Coronariana/mortalidade , Doença da Artéria Coronariana/diagnóstico , Prevalência , Vasos Coronários/fisiopatologia , Vasos Coronários/diagnóstico por imagem , Medição de RiscoRESUMO
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.
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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.
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Doença da Artéria Coronariana , Aprendizado de Máquina , Intervenção Coronária Percutânea , Humanos , Doença da Artéria Coronariana/cirurgia , Doença da Artéria Coronariana/mortalidade , Masculino , Feminino , Idoso , Pessoa de Meia-Idade , Fatores de Risco , Sistema de Registros , Revascularização Miocárdica , PolôniaRESUMO
Balloon angioplasty achieves luminal enlargement by fracturing the atherosclerotic intima at its point of least resistance, thereby creating a dissection plane and space with dehiscence of the intima from the media. This barotraumatic dissection triggers an inflammatory and proliferative reaction, resulting in a restenosis process at medium-term. In the era of plain old balloon angioplasty, quantitative angiographic studies at follow-up demonstrated that - the greater the acute luminal gain was after balloon angioplasty, the greater the late luminal loss was at follow-up. The interventional cardiologists coined the following motto "the more you gain, the more you lose". However, in the current era of drug coated balloon (DCB), it appears that this vexing conundrum could have been abrogated. A recently published DCB study in small de novo vessel has demonstrated that there was a slightly negative correlation between the volume of dissection assessed by optical coherence tomography and the angiographic late luminal loss (now gain) after Paclitaxel coated balloon treatment. In other words, the barotraumatic dissection does not necessarily herald a restenosis process in the era of DCB. This article revisits the mechanism of balloon angioplasty and explores how DCB with Paclitaxel may change the paradigm of balloon angioplasty as default treatment in CAD percutaneous treatment.
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BACKGROUND AND AIMS: In patients with three-vessel disease and/or left main disease, selecting revascularization strategy based on coronary computed tomography angiography (CCTA) has a high level of virtual agreement with treatment decisions based on invasive coronary angiography (ICA). METHODS: In this study, coronary artery bypass grafting (CABG) procedures were planned based on CCTA without knowledge of ICA. The CABG strategy was recommended by a central core laboratory assessing the anatomy and functionality of the coronary circulation. The primary feasibility endpoint was the percentage of operations performed without access to the ICA. The primary safety endpoint was graft patency on 30-day follow-up CCTA. Secondary endpoints included topographical adequacy of grafting, major adverse cardiac and cerebrovascular (MACCE), and major bleeding events at 30 days. The study was considered positive if the lower boundary of confidence intervals (CI) for feasibility was ≥75% (NCT04142021). RESULTS: The study enrolled 114 patients with a mean (standard deviation) anatomical SYNTAX score and Society of Thoracic Surgery score of 43.6 (15.3) and 0.81 (0.63), respectively. Unblinding ICA was required in one case yielding a feasibility of 99.1% (95% CI 95.2%-100%). The concordance and agreement in revascularization planning between the ICA- and CCTA-Heart Teams was 82.9% with a moderate kappa of 0.58 (95% CI 0.50-0.66) and between the CCTA-Heart Team and actual treatment was 83.7% with a substantial kappa of 0.61 (95% CI 0.53-0.68). The 30-day follow-up CCTA in 102 patients (91.9%) showed an anastomosis patency rate of 92.6%, whilst MACCE was 7.2% and major bleeding 2.7%. CONCLUSIONS: CABG guided by CCTA is feasible and has an acceptable safety profile in a selected population of complex coronary artery disease.
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Angiografia por Tomografia Computadorizada , Angiografia Coronária , Ponte de Artéria Coronária , Doença da Artéria Coronariana , Estudos de Viabilidade , Humanos , Ponte de Artéria Coronária/métodos , Masculino , Feminino , Pessoa de Meia-Idade , Doença da Artéria Coronariana/cirurgia , Doença da Artéria Coronariana/diagnóstico por imagem , Idoso , Angiografia por Tomografia Computadorizada/métodos , Angiografia Coronária/métodos , Estudos Prospectivos , Grau de Desobstrução Vascular/fisiologiaRESUMO
BACKGROUND: Recently, machine learning algorithms have identified preprocedural γ-glutamyl transferase (GGT) as a significant predictor of long-term mortality after coronary revascularization in the SYNTAX (Synergy Between PCI [Percutaneous Coronary Intervention] With Taxus and Cardiac Surgery) trial. The aim of the present study is to investigate the impact of preprocedural GGT on 10-year all-cause mortality in patients with complex coronary artery disease after revascularization. METHODS AND RESULTS: The SYNTAX trial was a randomized trial comparing PCI with coronary artery bypass grafting in 1800 patients with complex coronary artery disease. The present report is a post hoc subanalysis of the SYNTAXES (Synergy Between PCI With Taxus and Cardiac Surgery Extended Survival) trial, an investigator-driven extended 10-year follow-up of the SYNTAX trial. The association between preprocedural GGT and 10-year all-cause mortality was investigated. The mean values of GGT for men and women were 43.5 (SD, 48.5) and 36.4 (SD, 46.1) U/L, respectively. In multivariable Cox regression models adjusted by traditional risk factors, GGT was an independent predictor for all-cause death at 10-year follow-up, and each SD increase in log-GGT was associated with a 1.24-fold risk of all cause death at 10-year follow-up (95% CI, 1.10-1.40). According to previously reported sex-related GGT thresholds, patients with higher GGT level had a 1.74-fold risk of all-cause death at 10-year follow-up (95% CI, 1.32-2.29) compared with patients with lower GGT level. CONCLUSIONS: Preprocedural GGT is an independent predictor of 10-year mortality after coronary revascularization in patients with complex coronary artery disease. In patients with elevated GGT, strong secondary prevention may be required after revascularization and must be studied prospectively. REGISTRATION: URL: https://clinicaltrials.gov/study/NCT03417050.
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Doença da Artéria Coronariana , Intervenção Coronária Percutânea , Masculino , Humanos , Feminino , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/cirurgia , gama-Glutamiltransferase , Resultado do Tratamento , Fatores de Risco , FígadoRESUMO
Background: The ASET (Acetyl-Salicylic Elimination Trial) pilot studies recently investigated P2Y12 inhibitor monotherapy without aspirin immediately after percutaneous coronary intervention (PCI) in Brazil and Japan. Objectives: This comparative analysis of the 2 ASET pilot studies aimed to summarize clinical outcomes and assess geographic and ethnic differences in baseline demographics and procedures. Methods: Patients undergoing successful platinum-chromium everolimus-eluting stent implantation for chronic coronary syndrome were included. Following the index PCI, patients received prasugrel monotherapy with a maintenance dose of 10 mg/day in Brazil and 3.75 mg/day in Japan. The primary ischemic endpoint was the composite of cardiac death, spontaneous target vessel myocardial infarction, or deï¬nite stent thrombosis. The primary bleeding endpoint was Bleeding Academic Research Consortium types 3 and 5 bleeding at up to 3 months. Results: Of 409 enrollments, 3-month follow-up was completed in 406 patients. Mean age was 64.3 ± 8.4 years, and 73% were men. Overall, post-TIMI flow grade 3 was achieved in 99.8%. Intravascular imaging for poststent optimization was used in 16.8% and 99.6% of treated lesions in Brazil and Japan, respectively. The primary ischemic and bleeding endpoints occurred in the same patient (0.2%). No stent thrombosis events occurred. Conclusions: Prasugrel monotherapy following PCI was safe and feasible in selected low-risk chronic coronary syndrome patients after optimal platinum-chromium everolimus-eluting stent implantation regardless of the ethnic and geographic differences in baseline demographics, procedures, and prasugrel dosage. Randomized controlled trials will be needed to compare P2Y12 inhibitor monotherapy without aspirin with the current standard of care.
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Aims: Mixed reality (MR) holograms can display high-definition images while preserving the user's situational awareness. New MR software can measure 3D objects with gestures and voice commands; however, these measurements have not been validated. We aimed to assess the feasibility and accuracy of using 3D holograms for measuring the length of coronary artery bypass grafts. Methods and results: An independent core lab analyzed follow-up computer tomography coronary angiograms performed 30 days after coronary artery bypass grafting in 30 consecutive cases enrolled in the FASTTRACK CABG trial. Two analysts, blinded to clinical information, performed holographic reconstruction and measurements using the CarnaLife Holo software (Medapp, Krakow, Poland). Inter-observer agreement was assessed in the first 20 cases. Another analyst performed the validation measurements using the CardIQ W8 CT system (GE Healthcare, Milwaukee, Wisconsin). Seventy grafts (30 left internal mammary artery grafts, 31 saphenous vein grafts, and 9 right internal mammary artery grafts) were measured. Holographic measurements were feasible in 97.1% of grafts and took 3â minutes 36â s ± 50.74â s per case. There was an excellent inter-observer agreement [interclass correlation coefficient (ICC) 0.99 (0.97-0.99)]. There was no significant difference between the total graft length on hologram and CT [187.5â mm (157.7-211.4) vs. 183.1â mm (156.8-206.1), P = 0.50], respectively. Hologram and CT measurements are highly correlated (r = 0.97, P < 0.001) with an excellent agreement [ICC 0.98 (0.97-0.99)]. Conclusion: Real-time holographic measurements are feasible, quick, and accurate even for tortuous bypass grafts. This new methodology can empower clinicians to visualize and measure 3D images by themselves and may provide insights for procedural strategy.
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BACKGROUND: The geographical disparity in the pathophysiological pattern of coronary artery disease (CAD) among patients undergoing percutaneous coronary intervention (PCI) is unknown. OBJECTIVES: To elucidate the geographical variance in the pathophysiological characteristics of CAD. METHODS: Physiological indices derived from angiography-based fractional flow reserve pullbacks from patients with chronic coronary syndrome enrolled in the ASET Japan (n = 206) and ASET Brazil (n = 201) studies, which shared the same eligibility criteria, were analysed. The pathophysiological patterns of CAD were characterised using Murray law-based quantitative flow ratio (µQFR)-derived indices acquired from pre-PCI angiograms. The diffuseness of CAD was defined by the µQFR pullback pressure gradient index. RESULTS: Significant functional stenoses pre-PCI (µQFR ≤0.80) were more frequent in ASET Japan compared to ASET Brazil (89.9% vs. 67.5%, p < 0.001), as were rates of a post-PCI µQFR <0.91 (22.1% vs. 12.9%, p = 0.013). In the multivariable analysis, pre-procedural µQFR and diffuse disease were independent factors for predicting a post-PCI µQFR <0.91, which contributed to the different rates of post-PCI µQFR ≥0.91 between the studies. Among vessels with a post-PCI µQFR <0.91, a consistent diffuse pattern of CAD pre- and post-PCI occurred in 78.3% and 76.7% of patients in ASET Japan and Brazil, respectively; only 6.3% (Japan) and 10.0% (Brazil) of vessels had a major residual gradient. Independent risk factors for diffuse disease were diabetes mellitus in ASET Japan, and age and male gender in Brazil. CONCLUSIONS: There was geographic disparity in pre-procedural angiography-based pathophysiological characteristics. The combined pre-procedural physiological assessment of vessel µQFR and diffuseness of CAD may potentially identify patients who will benefit most from PCI.
Assuntos
Doença da Artéria Coronariana , Reserva Fracionada de Fluxo Miocárdico , Intervenção Coronária Percutânea , Humanos , Masculino , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/epidemiologia , Intervenção Coronária Percutânea/efeitos adversos , Reserva Fracionada de Fluxo Miocárdico/fisiologia , Angiografia Coronária , Resultado do Tratamento , Vasos Coronários , Valor Preditivo dos TestesRESUMO
Background: Aortic regurgitation (AR) following transcatheter aortic valve replacement (TAVR) is a major predictor of short- and long-term survival. Thus far, no independent quantitative comparison of AR among commercially available transcatheter heart valves (THVs) has been performed. Objectives: We sought to assess and compare the degree of acute AR following TAVR between 11 commercially available THVs and update our previous multicenter, pooled analysis. Methods: Analyses were performed by an independent academic core lab using quantitative videodensitometry, a technique relying solely on the aortogram acquired after TAVR. The pooled analysis (n = 2665) included data from the initial cohort of 7 valves (Lotus [n = 546], Evolut PRO [n = 95], SAPIEN 3 [n = 397], Evolut R [n = 295], SAPIEN XT [n = 239], ACURATE neo [n = 120], and CoreValve [n = 532]) to which data from 4 new valves were added (ACURATE neo2 [n = 120], Myval [n = 108], VitaFlow [n = 105], and Venus-A [n = 113]). Results: The Lotus valve had the lowest mean AR (3.5% ± 4.4%) followed by ACURATE neo2 (4.4% ± 4.8%), VitaFlow (6.1% ± 6.4%), Myval (6.3% â± â6.3%), Evolut PRO (7.4% ± 6.5%), SAPIEN 3 (7.6% ± 7.1%), Evolut R (7.9% ± 7.4%), SAPIEN XT (8.8% ± 7.5%), Venus-A (8.9% â± â10%), ACURATE neo (9.6% ± 9.2%), and CoreValve (13.7% ± 10.7%, analysis of variance P-value < .001). The only valves that statistically differed from all their counterparts were Lotus, with the lowest regurgitation in comparison to other valves except ACURATE neo2, which had less regurgitation compared with SAPIEN 3, Evolut R, SAPIEN XT, Venus-A, ACURATE neo, and CoreValve. CoreValve had the highest mean of AR, with the rates of moderate/severe AR: ACURATE neo2 (1.7%), Lotus (2.2%), Myval (2.8%), VitaFlow (4.7%), Evolut PRO (5.3%), SAPIEN 3 (8.3%), Evolut R (8.8%), SAPIEN XT (10.9%), ACURATE neo (11.3%), Venus-A (14.2%), and CoreValve (30.1%)-χ2 P-value < .001. Conclusions: In this updated pooled analysis, the Lotus valve had the lowest mean AR, while ACURATE neo2 had the lowest rate of moderate/severe AR. Myval, VitaFlow, and Venus-A THVs showed promising results.
RESUMO
Background: Personalized prognosis plays a vital role in deciding between percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) in patients with three-vessel disease (3VD). The aim of this study is to compare the modality of revascularization chosen by the local heart team to that recommended by using individualized predictions of medium, and long-term all-cause mortality amongst patients with 3VD screened in the Multivessel TALENT trial. Methods: The SYNTAX score II (SS-II) and SS-2020 were evaluated in 200 consecutive patients by a core laboratory and compared to the decision of the "on site" heart team. Results: According to the SS-II, CABG was the recommended treatment in 51 patients (25.5%) however 34 (66.6%) of them received PCI. According to SS-2020 the predicted absolute risk differences (ARD) between PCI and CABG were significantly higher in patients receiving CABG compared to those treated by PCI for major adverse cardiovascular and cerebrovascular events, a composite of all-cause mortality, stroke or myocardial infarction at 5-years (8.8 ± 4.6% vs 6.0 ± 4.0%, p < 0.001) and all-cause mortality at 5- (5.2 ± 3.5% vs 3.7 ± 3.0%, p = 0.008) and 10-years (9.3 ± 4.8% vs 6.2 ± 4.2%, p < 0.001). Based on the novel threshold of equipoise (individual absolute risk differences [ARD] < 4.5%), 133 patients were eligible for PCI however 23 of them underwent CABG; conversely, amongst the 67 patients where CABG was recommendation (individual ARD > 4.5%), only 19 received it. Conclusions: Despite the robustness of the risk models proposed for screening, several deviations from the recommended mode of revascularization were observed by the core laboratory among the first 200 patients with 3VD screened in the Multivessel TALENT trial. Clinical Trial Registration: ClinicalTrials.gov reference: NCT04390672.