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Background: The primary objective of this study was to evaluate the initial experience in Germany with the Meril Myval™ (MM) transcatheter heart valve (THV) system for the treatment of severe symptomatic aortic valve stenosis. The MM THV is a novel balloon-expandable valve with an expanded sizing matrix. Contemporary patients undergoing TAVI with the established Edwards Sapien™ (ES) THV served as the comparator group. Methods: Between 1st March and 31 August 2020 a total of 134 patients (33% female, 80.1 ± 6.7 years; EuroScore II 4.7 ± 4.8) underwent TAVI with an MM (95% transfemoral) for severe aortic stenosis at six German tertiary care centers. Results: Correct positioning of the THV was achieved in 98.5% (n = 132). Mean aortic gradients (MPG) were reduced from 42 ± 14 mmHg to 11 ± 5 mmHg. Mild postprocedural paravalvular leak (PVL) was observed in 62% (n = 82) patients, whereas only one patient had more than mild PVL. New permanent pacemaker implantation (PPI) was indicated in 15 patients (11%). Major vascular complications occurred in 6.7% (n = 9) patients. The in-hospital combined incidence of all-cause death and stroke was 4.5% (n = 6). In the comparator group that included 268 patients, the 30-day incidences of PPI, major vascular complications, and the composite of all-cause death and stroke were 16%, 1.9%, and 7.1%, respectively; MPGs were reduced from 44 ± 15 mmHg to 12.8 ± 4.6 mmHg and the more than mild PVL occurred in 0.7%. Conclusions: The MM is a promising novel THV system, with performance comparable to the established ES THVs. These findings await confirmation by ongoing randomized trials.
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BACKGROUND: A short dual antiplatelet therapy (DAPT) duration has been proposed for patients at high bleeding risk (HBR) undergoing drug-eluting coronary stent (DES) implantation. Whether this strategy is safe and effective after a non-ST-segment elevation acute coronary syndrome (NSTE-ACS) remains uncertain. AIMS: We aimed to compare the impact of 1-month versus 3-month DAPT on clinical outcomes after DES implantation among HBR patients with or without NSTE-ACS. METHODS: This is a prespecified analysis from the XIENCE Short DAPT programme involving three prospective, international, single-arm studies evaluating the safety and efficacy of 1-month (XIENCE 28 USA and Global) or 3-month (XIENCE 90) DAPT among HBR patients after implantation of a cobalt-chromium everolimus-eluting stent. Ischaemic and bleeding outcomes associated with 1- versus 3-month DAPT were assessed according to clinical presentation using propensity score stratification. RESULTS: Of 3,364 HBR patients (1,392 on 1-month DAPT and 1,972 on 3-month DAPT), 1,164 (34.6%) underwent DES implantation for NSTE-ACS. At 12 months, the risk of the primary endpoint of death or myocardial infarction was similar between 1- and 3-month DAPT in patients with (hazard ratio [HR] 1.09, 95% confidence interval [CI]: 0.71-1.65) and without NSTE-ACS (HR 0.88, 95% CI: 0.63-1.23; p-interaction=0.34). The key secondary endpoint of Bleeding Academic Research Consortium (BARC) Type 2-5 bleeding was consistently reduced in both NSTE-ACS (HR 0.57, 95% CI: 0.37-0.88) and stable patients (HR 0.84, 95% CI: 0.61-1.15; p-interaction=0.15) with 1-month DAPT. CONCLUSIONS: Among HBR patients undergoing implantation of an everolimus-eluting stent, 1-month, compared to 3-month DAPT, was associated with similar ischaemic risk and reduced bleeding at 1 year, irrespective of clinical presentation.
Subject(s)
Acute Coronary Syndrome , Drug-Eluting Stents , Dual Anti-Platelet Therapy , Hemorrhage , Percutaneous Coronary Intervention , Platelet Aggregation Inhibitors , Humans , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/methods , Percutaneous Coronary Intervention/instrumentation , Acute Coronary Syndrome/therapy , Platelet Aggregation Inhibitors/therapeutic use , Platelet Aggregation Inhibitors/adverse effects , Platelet Aggregation Inhibitors/administration & dosage , Male , Middle Aged , Aged , Female , Hemorrhage/chemically induced , Treatment Outcome , Dual Anti-Platelet Therapy/methods , Prospective Studies , Time Factors , Risk Factors , Non-ST Elevated Myocardial Infarction/therapy , Non-ST Elevated Myocardial Infarction/mortalityABSTRACT
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: The ISAR-REACT 5 trial compared the efficacy and safety of ticagrelor and prasugrel in patients with ACS managed invasively. The present study sought to investigate the impact of ticagrelor and prasugrel on the incidence and pattern of urgent revascularization in acute coronary syndromes (ACS) patients undergoing percutaneous coronary intervention (PCI). METHODS AND RESULTS: This post-hoc analysis of the ISAR-REACT 5 trial included all ACS patients who underwent PCI. The primary endpoint for this analysis was the incidence of urgent revascularization at 12-month follow-up. Secondary outcome was the pattern of urgent revascularization procedures (namely, urgent target vessel/non-target vessel revascularization - TVR/NTVR). Among 3,377 ACS patients who underwent PCI, 1,676 were assigned to ticagrelor and 1,701 to prasugrel before PCI. After 12 months, the incidence of urgent revascularization was higher among patients assigned to ticagrelor as compared to prasugrel (6.8% vs. 5.2%; hazard ratio [HR] = 1.32, 95% confidence interval [CI] 1.00-1.75; p = 0.051), mostly attributable to significantly more urgent NTVR in the ticagrelor group (3.8% vs. 2.4%; HR = 1.62 [1.09-2.41]; p = 0.017). The risk of urgent TVR did not differ between treatment groups (3.3% vs. 3.0%; HR = 1.13 [0.77-1.65]; p = 0.546). CONCLUSIONS: In ACS patients treated with PCI, the cumulative rate of urgent revascularizations after 12 months is higher with ticagrelor compared to prasugrel, due to a significant increase in urgent revascularizations involving remote coronary vessels.
Subject(s)
Acute Coronary Syndrome , Percutaneous Coronary Intervention , Platelet Aggregation Inhibitors , Prasugrel Hydrochloride , Ticagrelor , Humans , Ticagrelor/therapeutic use , Prasugrel Hydrochloride/therapeutic use , Acute Coronary Syndrome/therapy , Acute Coronary Syndrome/surgery , Male , Female , Percutaneous Coronary Intervention/methods , Middle Aged , Incidence , Platelet Aggregation Inhibitors/therapeutic use , Treatment Outcome , Aged , Follow-Up Studies , Time FactorsABSTRACT
Background: The goal of our study is to evaluate a method to quantify aortic valve calcification (AVC) in contrast-enhanced computed tomography for patients with suspected severe aortic stenosis pre-interventionally. Methods: A total of sixty-five patients with aortic stenosis underwent both a native and a contrast-enhanced computed tomography (CECT) scan of the aortic valve (45 in the training cohort and 20 in the validation cohort) using a standardized protocol. Aortic valve calcification was semi-automatically quantified via the Agatston score method for the native scans and was used as a reference. For contrast-enhanced computed tomography, a calcium threshold of the Hounsfield units of the aorta plus four times the standard deviation was used. Results: For the quantification of aortic valve calcification in contrast-enhanced computed tomography, a conversion formula (691 + 1.83 x AVCCECT) was derived via a linear regression model in the training cohort. The validation in the second cohort showed high agreement for this conversion formula with no significant proportional bias (Bland-Altman, p = 0.055) and with an intraclass correlation coefficient in the validation cohort of 0.915 (confidence interval 95% 0.786-0.966) p < 0.001. Conclusions: Calcium scoring in patients with aortic valve stenosis can be performed using contrast-enhanced computed tomography with high validity. Using a conversion factor led to an excellent agreement, thereby obviating an additional native computed tomography scan. This might contribute to a decrease in radiation exposure.
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BACKGROUND: Among low-risk patients with severe, symptomatic aortic stenosis who are eligible for both transcatheter aortic-valve implantation (TAVI) and surgical aortic-valve replacement (SAVR), data are lacking on the appropriate treatment strategy in routine clinical practice. METHODS: In this randomized noninferiority trial conducted at 38 sites in Germany, we assigned patients with severe aortic stenosis who were at low or intermediate surgical risk to undergo either TAVI or SAVR. Percutaneous- and surgical-valve prostheses were selected according to operator discretion. The primary outcome was a composite of death from any cause or fatal or nonfatal stroke at 1 year. RESULTS: A total of 1414 patients underwent randomization (701 to the TAVI group and 713 to the SAVR group). The mean (±SD) age of the patients was 74±4 years; 57% were men, and the median Society of Thoracic Surgeons risk score was 1.8% (low surgical risk). The Kaplan-Meier estimate of the primary outcome at 1 year was 5.4% in the TAVI group and 10.0% in the SAVR group (hazard ratio for death or stroke, 0.53; 95% confidence interval [CI], 0.35 to 0.79; P<0.001 for noninferiority). The incidence of death from any cause was 2.6% in the TAVI group and 6.2% in the SAVR group (hazard ratio, 0.43; 95% CI, 0.24 to 0.73); the incidence of stroke was 2.9% and 4.7%, respectively (hazard ratio, 0.61; 95% CI, 0.35 to 1.06). Procedural complications occurred in 1.5% and 1.0% of patients in the TAVI and SAVR groups, respectively. CONCLUSIONS: Among patients with severe aortic stenosis at low or intermediate surgical risk, TAVI was noninferior to SAVR with respect to death from any cause or stroke at 1 year. (Funded by the German Center for Cardiovascular Research and the German Heart Foundation; DEDICATE-DZHK6 ClinicalTrials.gov number, NCT03112980.).
Subject(s)
Aortic Valve Stenosis , Transcatheter Aortic Valve Replacement , Aged , Female , Humans , Male , Aortic Valve/surgery , Aortic Valve Stenosis/surgery , Aortic Valve Stenosis/mortality , Heart Valve Prosthesis , Heart Valve Prosthesis Implantation/adverse effects , Heart Valve Prosthesis Implantation/methods , Heart Valve Prosthesis Implantation/mortality , Kaplan-Meier Estimate , Stroke/epidemiology , Stroke/etiology , Stroke/mortality , Transcatheter Aortic Valve Replacement/adverse effects , Transcatheter Aortic Valve Replacement/instrumentation , Transcatheter Aortic Valve Replacement/methods , Transcatheter Aortic Valve Replacement/mortality , Risk Factors , GermanyABSTRACT
PURPOSE: Patient-specific simulations of transcatheter aortic valve (TAV) using computational fluid dynamics (CFD) often rely on assumptions regarding proximal and distal anatomy due to the limited availability of high-resolution imaging away from the TAV site and the primary research focus being near the TAV. However, the influence of these anatomical assumptions on computational efficiency and resulting flow characteristics remains uncertain. This study aimed to investigate the impact of different distal aortic arch anatomies-some of them commonly used in literature-on flow and hemodynamics in the vicinity of the TAV using large eddy simulations (LES). METHODS: Three aortic root anatomical configurations with four representative distal aortic arch types were considered in this study. The arch types included a 90-degree bend, an idealized distal aortic arch anatomy, a clipped version of the idealized distal aortic arch, and an anatomy extruded along the normal of segmented anatomical boundary. Hemodynamic parameters both instantaneous and time-averaged such as Wall Shear Stress (WSS), and Oscillatory Shear Index (OSI) were derived and compared from high-fidelity CFD data. RESULTS: While there were minor differences in flow and hemodynamics across the configurations examined, they were generally not significant within our region of interest i.e., the aortic root. The choice of extension type had a modest impact on TAV hemodynamics, especially in the vicinity of the TAV with variations observed in local flow patterns and parameters near the TAV. However, these differences were not substantial enough to cause significant deviations in the overall flow and hemodynamic characteristics. CONCLUSIONS: The results suggest that under the given configuration and boundary conditions, the type of outflow extension had a modest impact on hemodynamics proximal to the TAV. The findings contribute to a better understanding of flow dynamics in TAV configurations, providing insights for future studies in TAV-related experiments as well as numerical simulations. Additionally, they help mitigate the uncertainties associated with patient-specific geometries, offering increased flexibility in computational modeling.
Subject(s)
Aorta, Thoracic , Aortic Valve , Hemodynamics , Models, Cardiovascular , Patient-Specific Modeling , Humans , Aorta, Thoracic/anatomy & histology , Aorta, Thoracic/physiology , Aorta, Thoracic/diagnostic imaging , Aortic Valve/anatomy & histology , Aortic Valve/diagnostic imaging , Hydrodynamics , Transcatheter Aortic Valve Replacement , Computer Simulation , Blood Flow Velocity , Regional Blood Flow , Stress, MechanicalABSTRACT
This analysis aimed to evaluate the effect of 1- versus 3-month dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) in older patients. Data from 3 prospective, single-arm studies (XIENCE Short DAPT Program), including patients with high bleeding risk successfully treated with an everolimus-eluting stent (XIENCE, Abbott) were analyzed. DAPT was discontinued at 1 or at 3 months in patients free from ischemic events and adherent to DAPT. Patients were stratified according to age (≥75 and <75 years). The primary end point was all-cause death or myocardial infarction (MI). The key secondary end point was Bleeding Academic Research Consortium type 2 to 5 bleeding. The outcomes were assessed from 1 to 12 months after index PCI. Of 3,364 patients, 2,241 (66.6%) were aged ≥75 years. The risk of death or MI was similar with 1- versus 3-month DAPT in patients aged ≥75 (8.5% vs 8.0%, adjusted hazard ratio [HR] 0.95, 95% confidence interval [CI] 0.69 to 1.30) and <75 years (6.9% vs 7.8%, adjusted HR 0.97, 95% CI 0.60 to 1.57, interaction p = 0.478). Bleeding Academic Research Consortium type 2 to 5 bleeding was consistently lower with 1- than with 3-month DAPT in patients aged ≥75 years (7.2% vs 9.4%, adjusted HR 0.66, 95% CI 0.48 to 0.91) and <75 years (9.7% vs 11.9%, adjusted HR 0.86, 95% CI 0.57 to 1.29, interaction p = 0.737). In conclusion, in patients at high bleeding risk who underwent PCI, patients older and younger than 75 years derived a consistent benefit from 1- compared with 3-month DAPT in terms of bleeding reduction, with no increase in all-cause death or MI at 1 year.
Subject(s)
Drug-Eluting Stents , Myocardial Infarction , Percutaneous Coronary Intervention , Humans , Aged , Platelet Aggregation Inhibitors/therapeutic use , Percutaneous Coronary Intervention/adverse effects , Prospective Studies , Drug Therapy, Combination , Hemorrhage/epidemiology , Hemorrhage/chemically induced , Myocardial Infarction/epidemiology , Myocardial Infarction/drug therapy , Treatment OutcomeABSTRACT
BACKGROUND: The prognostic impact of contrast-associated acute kidney injury (CA-AKI) in patients undergoing chronic total occlusion (CTO) percutaneous coronary intervention (PCI) remains underestimated. METHODS: We examined 2707 consecutive procedures performed in a referral CTO center between 2015 and 2019. CA-AKI was defined as an increase in serum creatinine ≥ 0.3 mg/dL or ≥ 50% within 48 h post-PCI. Primary endpoints were in-hospital major adverse cardiac and cerebrovascular events (MACCE, composite of all-cause death, myocardial infarction, target vessel revascularization, stroke) and at one year of follow-up. RESULTS: The overall incidence of CA-AKI was 11.5%. Technical success was comparable (87.2% vs. 90.5%, p = 0.056) whereas procedural success was lower in the CA-AKI group (84.3% vs. 89.7%, p = 0.004). Overall in-hospital MACCE was 1.3%, and it was similar in patients with and without CA-AKI (1.6% vs. 1.3%, p = 0.655); however, the rate of pericardial tamponade requiring pericardiocentesis was significantly higher in patients with CA-AKI (2.2% vs. 0.5%, p = 0.001). In multivariate analysis, CA-AKI was not independently associated with higher risk for in-hospital MACCE (adjusted odds ratio [OR] 1.34, 95% confidence intervals [CI] 0.45-3.19, p = 0.563). At a median follow-up time of 14 months (interquartile range [IQR], 11 to 35 months), one-year MACCE was significantly higher in patients with vs. without CA-AKI (20.8% vs. 12.8%, p < 0.001), and CA-AKI increased the risk for one-year MACCE (adjusted hazard ratio [HR] 1.46, 95% CI 1.07-1.95, p = 0.017) following CTO PCI. CONCLUSIONS: CA-AKI in patients undergoing CTO PCI occurs in approximately one out of 10 patients. Our study highlights that patients developing CA-AKI are at increased risk for long-term MACCE.
Subject(s)
Acute Kidney Injury , Coronary Occlusion , Myocardial Infarction , Percutaneous Coronary Intervention , Humans , Treatment Outcome , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/methods , Myocardial Infarction/etiology , Prognosis , Acute Kidney Injury/chemically induced , Acute Kidney Injury/diagnosis , Acute Kidney Injury/epidemiology , Coronary Occlusion/diagnosis , Coronary Occlusion/surgery , Coronary Occlusion/etiology , Risk FactorsABSTRACT
BACKGROUND: Estimation of regurgitant fraction by videodensitometry (VD-AR) of aortic root angiograms is a new tool for objective grading of paravalvular regurgitation (PVR) after transcatheter aortic valve implantation (TAVI). Stratification with boundaries at 6% and 17% has been proposed to reflect "none/trace", "mild" and "moderate or higher" PVR. OBJECTIVE: We sought to investigate the association of strata of VD-AR with 3-year mortality and to compare VD-AR with visual grading of angiograms. METHODS: We interrogated our database for patients undergoing transfemoral TAVI from 2008 to 2018. Vital status of the patients was obtained from population registers. To test differences in survival and estimate adjusted hazard ratios (HRs) we fitted Cox models. RESULTS: Our retrospective study included 699 patients with evaluable angiograms at completion of the TAVI procedure. Cumulative 3-year mortality was 35.0% in 261 (37.3%) patients with VD-AR < 6%, 33.9% in 325 (46.5%) patients with VD-AR between 6 and 17% (HR [95% confidence interval] 1.06 [0.80-1.42]; P = 0.684) and 47.2% in 113 (16.2%) patients with VD-AR > 17% (HR 1.57 [1.11-2.22]; P = 0.011). Visually, PVR was graded as "none/trace" in 470 (67.2%) patients, as "mild" in 219 (31.3%) and as "moderate" in 10 (1.4%). Both mild PVR and moderate PVR on visual grading were significantly associated with mortality (HRs 1.31 [1.12-1.54]; P = 0.001 and 1.92 [1.13-3.24]; P = 0.015; respectively). CONCLUSIONS: VD-AR > 17%, but not VD-AR 6-17%, was independently associated with mortality. Compared with subjective visual evaluation, VD-AR resulted in a smaller proportion of patients with PVR classified as prognostically relevant.
Subject(s)
Aortic Valve Insufficiency , Aortic Valve Stenosis , Heart Valve Prosthesis , Transcatheter Aortic Valve Replacement , Humans , Transcatheter Aortic Valve Replacement/methods , Retrospective Studies , Angiography , Proportional Hazards Models , Aortic Valve Stenosis/surgery , Aortic Valve/surgery , Treatment Outcome , Severity of Illness IndexABSTRACT
Background: We aimed to evaluate the feasibility of a non-contrast time-of-flight magnetic resonance angiography (TOF-MRA) protocol for the pre-procedural access route assessment of transcatheter aortic valve implantation (TAVI) in comparison with contrast-enhanced cardiac dual-source computed tomography angiography (CTA). Methods and Results: In total, 51 consecutive patients (mean age: 82.69 ± 5.69 years) who had undergone a pre-TAVI cardiac CTA received TOF-MRA for a pre-procedural access route assessment. The MRA image quality was rated as very good (median of 5 [IQR 4-5] on a five-point Likert scale), with only four examinations rated as non-diagnostic. The TOF-MRA systematically underestimated the minimal effective vessel diameter in comparison with CTA (for the effective vessel diameter in mm, the right common iliac artery (CIA)/external iliac artery (EIA)/common femoral artery (CFA) MRA vs. CTA was 8.04 ± 1.46 vs. 8.37 ± 1.54 (p < 0.0001) and the left CIA/EIA/CFA MRA vs. CTA was 8.07 ± 1.32 vs. 8.28 ± 1.34 (p < 0.0001)). The absolute difference between the MRA and CTA was small (for the Bland-Altman analyses in mm, the right CIA/EIA/CFA was -0.36 ± 0.77 and the left CIA/EIA/CFA was -0.25 ± 0.61). The overall correlation between the MRA and CTA measurements was very good (with a Pearson correlation coefficient of 0.87 (p < 0.0001) for the right CIA/EIA/CFA and a Pearson correlation coefficient of 0.9 (p < 0.0001) for the left CIA/EIA/CFA). The feasibility agreement between the MRA and CTA for transfemoral access was good (the right CIA/EIA/CFA agreement was 97.9% and the left CIA/EIA/CFA agreement was 95.7%, Kohen's kappa: 0.477 (p = 0.001)). Conclusions: The TOF-MRA protocol was feasible for the assessment of the access route in an all-comer pre-TAVI population. This protocol might be a reliable technique for patients at an increased risk of contrast-induced nephropathy.
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BACKGROUND: The optimal duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) in patients on long-term oral anticoagulation (OAC) therapy is still uncertain. OBJECTIVES: The aim of this analysis was to assess the effects of 1- vs 3-month DAPT in patients with and those without concomitant OAC included in the XIENCE Short DAPT program. METHODS: The XIENCE Short DAPT program enrolled patients with high bleeding risk who underwent successful PCI with a cobalt-chromium everolimus-eluting stent. DAPT was discontinued at 1 or 3 months in patients free from ischemic events and adherent to treatment. The effect of 1- vs 3-month DAPT was compared in patients with and those without OAC using propensity score stratification. The primary endpoint was all-cause death or any myocardial infarction (MI). The key secondary endpoint was Bleeding Academic Research Consortium (BARC) types 2 to 5 bleeding. Outcomes were assessed from 1 to 12 months after index PCI. RESULTS: Among 3,364 event-free patients, 1,462 (43%) were on OAC. Among OAC patients, the risk for death or MI was similar between 1- and 3-month DAPT (7.4% vs 8.8%; adjusted HR: 0.74; 95% CI: 0.49-1.11; P = 0.139), whereas BARC types 2 to 5 bleeding was lower with 1-month DAPT (adjusted HR: 0.71; 95% CI: 0.51-0.99; P = 0.046). These effects were consistent in patients with and those without OAC (P for interaction = NS). CONCLUSIONS: Between 1 and 12 months after PCI, 1-month compared with 3-month DAPT was associated with similar rates of all-cause death or MI and a reduced rate of BARC types 2 to 5 bleeding, irrespective of OAC treatment.
Subject(s)
Drug-Eluting Stents , Myocardial Infarction , Percutaneous Coronary Intervention , Humans , Platelet Aggregation Inhibitors/adverse effects , Drug-Eluting Stents/adverse effects , Percutaneous Coronary Intervention/adverse effects , Treatment Outcome , Drug Therapy, Combination , Anticoagulants/adverse effects , Myocardial Infarction/etiology , Hemorrhage/chemically inducedABSTRACT
The EVOLVE Short DAPT study demonstrated the safety of truncated dual antiplatelet therapy (DAPT) in patients with a high bleeding risk (HBR) treated with SYNERGY stent(s) (Boston Scientific Company, Marlborough, Massachusetts). In this population, bleeding and ischemic risk prediction may further inform DAPT decisions. This post hoc analysis of the EVOLVE Short DAPT study identified predictors of ischemic and bleeding events up to 15 months using Cox proportional hazard models. The predicted probabilities of bleeding were calculated using the Breslow method. Of 2,009 enrolled patients, 96.9% of the patients met at least 1 HBR criteria. At 15 months, the cumulative incidences of bleeding and ischemic events were 6.3% and 6.0%, respectively. The risk of bleeding was increased in patients who received oral anticoagulants (hazard ratio [HR] 2.24, 95% confidence interval [CI] 1.50 to 3.36, p <0.001) or had peripheral vascular disease (HR 1.61, 95% CI 1.01 to 2.56, p = 0.045). The risk of ischemic events was increased in patients with diabetes (HR 1.86, 95% CI 1.24 to 2.78, p <0.01) or congestive heart failure (HR 2.06, 95% CI 1.39 to 3.04, p <0.001). Renal insufficiency/failure was associated with both endpoints. There was a strong positive correlation between the predicted probability of ischemic and bleeding events (R = 0.77, p <0.001). In 617 patients with a predicted bleeding risk <4%, ischemic events predominated, and the ischemic and bleeding rates were higher in patients with a predicted bleeding risk ≥4%. Within an HBR cohort, specific characteristics identify patients at a higher risk for ischemic and separately, bleeding events. Increased bleeding risk is tied to increased ischemic risk. In conclusion, standardized risk models are needed to inform DAPT decisions in patients with a higher risk. Clinical Trial Registration: NCT02605447.
Subject(s)
Dual Anti-Platelet Therapy , Hemorrhage , Humans , Drug Therapy, Combination , Dual Anti-Platelet Therapy/adverse effects , Dual Anti-Platelet Therapy/methods , Hemorrhage/chemically induced , Hemorrhage/epidemiology , Incidence , Platelet Aggregation Inhibitors/therapeutic use , Stents , Treatment OutcomeABSTRACT
BACKGROUND: In patients with ST-segment elevation myocardial infarction (STEMI) with multivessel coronary artery disease, the time at which complete revascularization of nonculprit lesions should be performed remains unknown. METHODS: We performed an international, open-label, randomized, noninferiority trial at 37 sites in Europe. Patients in a hemodynamically stable condition who had STEMI and multivessel coronary artery disease were randomly assigned to undergo immediate multivessel percutaneous coronary intervention (PCI; immediate group) or PCI of the culprit lesion followed by staged multivessel PCI of nonculprit lesions within 19 to 45 days after the index procedure (staged group). The primary end point was a composite of death from any cause, nonfatal myocardial infarction, stroke, unplanned ischemia-driven revascularization, or hospitalization for heart failure at 1 year after randomization. The percentages of patients with a primary or secondary end-point event are provided as Kaplan-Meier estimates at 6 months and at 1 year. RESULTS: We assigned 418 patients to undergo immediate multivessel PCI and 422 to undergo staged multivessel PCI. A primary end-point event occurred in 35 patients (8.5%) in the immediate group as compared with 68 patients (16.3%) in the staged group (risk ratio, 0.52; 95% confidence interval, 0.38 to 0.72; P<0.001 for noninferiority and P<0.001 for superiority). Nonfatal myocardial infarction and unplanned ischemia-driven revascularization occurred in 8 patients (2.0%) and 17 patients (4.1%), respectively, in the immediate group and in 22 patients (5.3%) and 39 patients (9.3%), respectively, in the staged group. The risk of death from any cause, the risk of stroke, and the risk of hospitalization for heart failure appeared to be similar in the two groups. A total of 104 patients in the immediate group and 145 patients in the staged group had a serious adverse event. CONCLUSIONS: Among patients in hemodynamically stable condition with STEMI and multivessel coronary artery disease, immediate multivessel PCI was noninferior to staged multivessel PCI with respect to the risk of death from any cause, nonfatal myocardial infarction, stroke, unplanned ischemia-driven revascularization, or hospitalization for heart failure at 1 year. (Supported by Boston Scientific; MULTISTARS AMI ClinicalTrials.gov number, NCT03135275.).
Subject(s)
Coronary Artery Disease , Percutaneous Coronary Intervention , ST Elevation Myocardial Infarction , Humans , Coronary Artery Disease/complications , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/surgery , Coronary Vessels/surgery , Europe , Heart Failure/etiology , Myocardial Infarction/etiology , Myocardial Infarction/surgery , Myocardial Revascularization/adverse effects , Myocardial Revascularization/methods , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/methods , Percutaneous Coronary Intervention/mortality , ST Elevation Myocardial Infarction/etiology , ST Elevation Myocardial Infarction/mortality , ST Elevation Myocardial Infarction/surgery , Stroke/etiology , Time Factors , Treatment Outcome , Time-to-TreatmentABSTRACT
Recent data suggest that uric acid (UA) might be an independent predictor of clinical outcomes following percutaneous coronary intervention (PCI). The predictive value of uric acid in patients undergoing PCI for chronic total occlusions (CTO) is unknown. We included patients with CTO who underwent PCI at our center in 2005 and 2012, with available uric acid levels before angiography. Subjects were divided into groups according to uric acid tertiles (<5.5 mg/dL, 5.6-6.9 mg/dL, and >7.0 mg/dL), and outcomes were compared among the groups. Out of the 1963 patients (mean age 65.2 ± 11 years), 34.7% (n = 682) had uric acid concentrations in the first tertile, 34.3% (n = 673) in the second tertile, and 31% (n = 608) in the third tertile. Median follow-up was 3.0 years. Uric acid levels in the first tertile were associated with significantly lower all-cause mortality, as compared to the third tertile, with an adjusted hazard ratio (HR) of 0.67 (95% confidence interval (CI): 0.49 to 0.92; p = 0.012). No significant differences regarding all-cause mortality were found between patients in the first and second tertiles (HR: 0.96 [95% CI: 0.71 to 1.3; p = 0.78]). High levels of uric acid emerged as an independent predictor of all-cause mortality in patients with chronic total occlusion treated with PCI. Hence, uric acid levels should be incorporated into the risk assessment of patients with CTO.
ABSTRACT
The study sought to assess the procedural success of rotational atherectomy (RA) in coronary chronic total occlusion (CTO) and to investigate the in-hospital and one-year outcomes following RA. From 2015 to 2019, patients undergoing percutaneous coronary intervention for CTO (CTO PCI) were retrospectively included into the hospital database. The primary endpoint was procedural success. Secondary endpoints were in-hospital and one-year major adverse cardiovascular and cerebral event (MACCE) rates. During the study period of 5 years, 2.789 patients underwent CTO PCI. Patients treated with RA (n = 193, 6.92%) had a significantly higher procedural success (93.26% vs. 85.10%, p = 0.0002) compared to those treated without RA (n = 2.596, 93.08%). Despite a significantly higher rate of pericardiocentesis (3.11% vs. 0.50%, p = 0.0013) in the RA group, the in-hospital and one-year MACCE rate was similar in both groups (4.15% vs. 2.77%, p = 0.2612; 18.65% vs. 16.72%, p = 0.485). In conclusion, RA is associated with higher procedural success for CTO PCI, but has higher risks for pericardial tamponade than CTO PCI without the need for RA. Nevertheless, in-hospital and one-year MACCE rates did not differ in-between both groups.
ABSTRACT
Aim: This study sought to develop and validate diagnostic models to identify individuals with atrial fibrillation (AF) using amplified sinus-p-wave analysis. Methods: A total of 1,492 patients (491 healthy controls, 499 with paroxysmal AF and 502 with persistent AF) underwent digital 12-lead-ECG recording during sinus rhythm. The patient cohort was divided into training and validation set in a 3:2 ratio. P-wave indices (PWI) including duration of standard p-wave (standard PWD; scale at 10 mm/mV, sweep speed at 25 mm/s) and amplified sinus-p-wave (APWD, scale at 60-120 mm/mV, sweep speed at 100 mm/s) and advanced inter-atrial block (aIAB) along with other clinical parameters were used to develop diagnostic models using logistic regression. Each model was developed from the training set and further tested in both training and validation sets for its diagnostic performance in identifying individuals with AF. Results: Compared to standard PWD (Reference model), which achieved an AUC of 0.637 and 0.632, for training and validation set, respectively, APWD (Basic model) importantly improved the accuracy to identify individuals with AF (AUC = 0.86 and 0.866). The PWI-based model combining APWD, aIAB and body surface area (BSA) further improved the diagnostic performance for AF (AUC = 0.892 and 0.885). The integrated model, which further combined left atrial diameter (LAD) with parameters of the PWI-based model, achieved optimal diagnostic performance (AUC = 0.916 and 0.902). Conclusion: Analysis of amplified p-wave during sinus rhythm allows identification of individuals with atrial fibrillation.
ABSTRACT
BACKGROUND: Evidence on the optimal timing of RA is scarce, although increased periprocedural complications for unplanned procedures have been reported. AIMS: To compare planned versus unplanned use of rotational atherectomy (RA) for plaque modification in patients with severely calcified coronary lesions. METHODS: Procedural and 1-year follow-up data of planned (n = 562 lesions in 448 vessels of 416 patients) and unplanned (n = 490 lesions in 435 vessels of 403 patients) RA between 2008 and 2020 were analyzed using the propensity score methods. The primary composite endpoint was target lesion failure (TLF), defined as cardiovascular death (CVD), target vessel myocardial infarction (TVMI), or target lesion revascularization (TLR). RESULTS: Angiographic success was > 99% in both groups. Fluoroscopy time and contrast volume were significantly lower in planned RA (p < 0.001). Periprocedural complications including slow-flow, coronary dissection, and MI occurred in 4.8% after planned, and in 5.7% after unplanned RA. TLF occurred in 18.5% after planned, and in 14.7% after unplanned RA. Weighted subdistribution hazard ratios for TLFs revealed an unfavorable 1-year outcome for planned RA (sHR 1.62 [1.07-2.45], p = 0.023), which was driven by TLR (sHR 2.01 [1.18-3.46], p = 0.011), but not by CVD, or TVMI. No differences were observed in all-cause mortality. CONCLUSIONS: Unplanned RA was associated with favorable outcome when compared to planned RA. Thus, RA can safely be reserved for lesions that prove untreatable by conventional means. Randomized and prospective trials are needed to evaluate a predominant use of rotational atherectomy as a bailout strategy in the future.
Subject(s)
Atherectomy, Coronary , Coronary Artery Disease , Myocardial Infarction , Percutaneous Coronary Intervention , Plaque, Atherosclerotic , Vascular Calcification , Humans , Atherectomy, Coronary/adverse effects , Atherectomy, Coronary/methods , Coronary Artery Disease/diagnosis , Coronary Artery Disease/surgery , Prospective Studies , Treatment Outcome , Vascular Calcification/diagnosis , Vascular Calcification/surgery , Time Factors , Coronary Angiography , Retrospective StudiesABSTRACT
AIMS: Transseptal puncture (TP) for left-sided catheter ablation procedures is routinely performed under fluoroscopic or echocardiographic guidance [transoesophageal echocardiography (TEE) or intracardiac echocardiography (ICE)], although three-dimensional (3D) mapping systems are readily available in most electrophysiology laboratories. Here, we sought to assess the feasibility and safety of a right atrial (RA) 3D map-guided TP. METHODS AND RESULTS: In 104 patients, 3D RA mapping was performed to identify the fossa ovalis (FO) using the protrusion technique. The radiofrequency transseptal needle was visualized and navigated to the desired potential FO-TP site. Thereafter, the interventionalist was unblinded to TEE and the potential FO-TP site was reassessed regarding its convenience and safety. After TP, the exact TP site was documented using a 17-segment-FO model. Reliable identification of the FO was feasible in 102 patients (98%). In these, 114 3D map-guided TP attempts were performed, of which 96 (84%) patients demonstrated a good position and 18 (16%) an adequate position after TEE unblinding. An out-of-FO or dangerous position did not occur. A successful 3D map-guided TP was performed in 110 attempts (97%). Four attempts (3%) with adequate positions were aborted in order to seek a more convenient TP site. The median time from RA mapping until the end of the TP process was 13 (12-17) min. No TP-related complications occurred. Ninety-eight TP sites (85.1%) were in the central portion or in the inner loop of the FO. CONCLUSION: A 3D map-guided TP is feasible and safe. It may assist to decrease radiation exposure and the need for TEE/ICE during left-sided catheter ablation procedures.