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1.
J Am Coll Cardiol ; 73(21): 2647-2655, 2019 Jun 04.
Artigo em Inglês | MEDLINE | ID: mdl-31146808

RESUMO

BACKGROUND: Transcatheter aortic valve replacement (TAVR) for degenerated surgical bioprosthetic aortic valves is associated with favorable early outcomes. However, little is known about the durability and longer-term outcomes associated with this therapy. OBJECTIVES: The aim of this study was to examine late outcomes after valve-in-valve TAVR. METHODS: Patients with symptomatic degeneration of surgical aortic bioprostheses at high risk (≥50% major morbidity or mortality) for reoperative surgery were prospectively enrolled in the multicenter PARTNER (Placement of Aortic Transcatheter Valves) 2 valve-in-valve and continued access registries. Three-year clinical and echocardiographic follow-up was obtained. RESULTS: Valve-in-valve procedures were performed in 365 patients. The mean age was 78.9 ± 10.2 years, and the mean Society of Thoracic Surgeons score was 9.1 ± 4.7%. At 3 years, the overall Kaplan-Meier estimate of all-cause mortality was 32.7%. Aortic valve re-replacement was required in 1.9%. Mean transaortic gradient was 35.0 mm Hg at baseline, decreasing to 17.8 mm Hg at 30-day follow-up and 16.6 mm Hg at 3-year follow-up. Baseline effective orifice area was 0.93 cm2, increasing to 1.13 and 1.15 cm2 at 30 days and 3 years, respectively. Moderate to severe aortic regurgitation was reduced from 45.1% at pre-TAVR baseline to 2.5% at 3 years. Importantly, moderate or severe mitral and tricuspid regurgitation also decreased (33.7% vs. 8.6% [p < 0.0001] and 29.7% vs. 18.8% [p = 0.002], respectively). Baseline left ventricular ejection fraction was 50.7%, increasing to 54.7% at 3 years (p < 0.0001), while left ventricular mass index was 136.4 g/m2, decreasing to 109.1 g/m2 at 3 years (p < 0.0001). New York Heart Association functional class improved, with 90.4% in class III or IV at baseline and 14.1% at 3 years (p < 0.0001), and Kansas City Cardiomyopathy Questionnaire overall score increased (43.1 to 73.1; p < 0.0001). CONCLUSIONS: At 3-year follow-up, TAVR for bioprosthetic aortic valve failure was associated with favorable survival, sustained improved hemodynamic status, and excellent functional and quality-of-life outcomes. (The PARTNER II Trial: Placement of Aortic Transcatheter Valves II - PARTNER II - Nested Registry 3/Valve-in-Valve [PII NR3/ViV]; NCT03225001).

2.
EuroIntervention ; 15(6): e531-e538, 2019 Aug 09.
Artigo em Inglês | MEDLINE | ID: mdl-31186220

RESUMO

AIMS: The impact of an occluded right coronary artery (RCA) in patients with left main coronary artery disease (LMCAD) undergoing revascularisation is unknown. We compared outcomes for patients with LMCAD randomised to percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) according to the presence of an occluded RCA in the EXCEL trial. METHODS AND RESULTS: The EXCEL trial randomised 1,905 patients with LMCAD and SYNTAX scores ≤32 to PCI with everolimus-eluting stents versus CABG. Patients were categorised according to whether they had an occluded RCA at baseline, and their outcomes were examined using multivariable Cox proportional hazards regression. The primary endpoint was a composite of death, stroke, or myocardial infarction at three years. Among 1,753 patients with a dominant RCA by core laboratory analysis, the RCA was occluded in 130 (7.4%) at baseline. PCI was attempted in 34 of 65 patients with an occluded RCA (52.3%) and was successful in 27 (79.4% of those attempted; 41.5% of all RCAs recanalised). The RCA was bypassed in 42 of 65 patients with an occluded RCA (64.6%; p=0.0008 versus PCI). The three-year absolute and relative rates of the primary endpoint were similar between PCI and CABG, in patients with or without an occluded RCA (pinteraction=0.92). CONCLUSIONS: In the EXCEL trial, the presence of an occluded RCA at baseline did not confer a worse three-year prognosis in patients undergoing revascularisation for LMCAD and did not affect the relative outcomes of PCI versus CABG in this high-risk patient cohort.


Assuntos
Ponte de Artéria Coronária/métodos , Doença da Artéria Coronariana/terapia , Stents Farmacológicos , Oclusão de Enxerto Vascular , Intervenção Coronária Percutânea/métodos , Acidente Vascular Cerebral/epidemiologia , Humanos , Prognóstico , Fatores de Tempo , Resultado do Tratamento
3.
J Am Coll Cardiol ; 73(15): 1877-1886, 2019 Apr 23.
Artigo em Inglês | MEDLINE | ID: mdl-30999989

RESUMO

BACKGROUND: Although results of percutaneous coronary intervention (PCI) have been steadily improving, whether surgical outcomes have improved over time is not fully elucidated. OBJECTIVES: This study sought to compare the current outcomes of patients undergoing coronary artery bypass grafting (CABG) with prior surgical results, in the context of randomized trials including the left main (LM) coronary artery stem. METHODS: The authors performed a propensity-matched analysis of patients randomized to CABG in the SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) (enrollment period 2005 to 2007) and EXCEL (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) (enrollment period 2010 to 2014) trials. All patients had left main (LM) disease with or without multivessel disease. Adjustment was based on 15 clinical and angiographic variables, including anatomic SYNTAX score, with a 2:1 ratio for the EXCEL and SYNTAX trials, collectively analyzing 909 subjects (n = 580 and n = 329, respectively). The primary endpoint was the composite of all-cause death, myocardial infarction (MI), stroke, or ischemia-driven revascularization at 3 years. RESULTS: Baseline characteristics, anatomic SYNTAX score, number and types of grafts, and duration of hospitalization for the procedures were similar in both groups. CABG procedures in the EXCEL compared with the SYNTAX trial were more often off-pump (29.6% vs. 15.4%; p < 0.001), and guideline-directed medical therapies were used more frequently in the EXCEL surgical cohort. The primary endpoint occurred in 14.0% and 20.9% (p = 0.008) of patients in the EXCEL and SYNTAX trials, respectively. With the exception of MI (4.1% vs. 3.7%), all nonhierarchical events tended to contribute to the improved outcomes in the more recent trial: all-cause death (5.5% vs. 8.5%), stroke (3.1% vs. 5.1%), and ischemia-driven revascularization (7.1% vs. 9.4%) in the EXCEL and SYNTAX trials, respectively. CONCLUSIONS: Over a 5- to 7-year period, significant improvement in event-free survival after surgical revascularization for LM disease at 3 years was noted between the SYNTAX and EXCEL trials, consistent with improving results with cardiac surgery over time. (Synergy Between PCI With Taxus and Cardiac Surgery [SYNTAX]; NCT00114972; Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization [EXCEL]; NCT01205776).

4.
J Am Coll Cardiol ; 73(13): 1616-1628, 2019 Apr 09.
Artigo em Inglês | MEDLINE | ID: mdl-30947913

RESUMO

BACKGROUND: The randomized EXCEL (Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial reported a similar rate of the 3-year composite primary endpoint of death, myocardial infarction (MI), or stroke in patients with left main coronary artery disease (LMCAD) and site-assessed low or intermediate SYNTAX scores treated with percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG). Whether these results are consistent in high-risk patients with diabetes, who have fared relatively better with CABG in most prior trials, is unknown. OBJECTIVES: In this pre-specified subgroup analysis from the EXCEL trial, the authors sought to examine the effect of diabetes in patients with LMCAD treated with PCI versus CABG. METHODS: Patients (N = 1,905) with LMCAD and site-assessed low or intermediate CAD complexity (SYNTAX scores ≤32) were randomized 1:1 to PCI with everolimus-eluting stents versus CABG, stratified by the presence of diabetes. The primary endpoint was the rate of a composite of all-cause death, stroke, or MI at 3 years. Outcomes were examined in patients with (n = 554) and without (n = 1,350) diabetes. RESULTS: The 3-year composite primary endpoint was significantly higher in diabetic compared with nondiabetic patients (20.0% vs. 12.9%; p < 0.001). The rate of the 3-year primary endpoint was similar after treatment with PCI and CABG in diabetic patients (20.7% vs. 19.3%, respectively; hazard ratio: 1.03; 95% confidence interval: 0.71 to 1.50; p = 0.87) and nondiabetic patients (12.9% vs. 12.9%, respectively; hazard ratio: 0.98; 95% confidence interval: 0.73 to 1.32; p = 0.89). All-cause death at 3 years occurred in 13.6% of PCI and 9.0% of CABG patients (p = 0.046), although no significant interaction was present between diabetes status and treatment for all-cause death (p = 0.22) or other endpoints, including the 3-year primary endpoint (p = 0.82) or the major secondary endpoints of death, MI, or stroke at 30 days (p = 0.61) or death, MI, stroke, or ischemia-driven revascularization at 3 years (p = 0.65). CONCLUSIONS: In the EXCEL trial, the relative 30-day and 3-year outcomes of PCI with everolimus-eluting stents versus CABG were consistent in diabetic and nondiabetic patients with LMCAD and site-assessed low or intermediate SYNTAX scores.(Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization [EXCEL]; NCT01205776).

5.
Eur Heart J ; 40(24): 1930-1941, 2019 Jun 21.
Artigo em Inglês | MEDLINE | ID: mdl-30919909

RESUMO

AIMS: The prognostic implications of periprocedural myocardial infarction (PMI) after percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) remain controversial. We examined the 3-year rates of mortality among patients with and without PMI undergoing left main coronary artery intervention randomized to PCI with everolimus-eluting stents vs. CABG in the large-scale, multicentre, prospective, randomized EXCEL trial. METHODS AND RESULTS: By protocol, PMI was defined using an identical threshold for PCI and CABG [creatinine kinase-MB (CK-MB) elevation >10× the upper reference limit (URL) within 72 h post-procedure, or >5× URL with new Q-waves, angiographic vessel occlusion, or loss of myocardium on imaging]. Cox proportional hazards modelling was performed controlling for age, sex, hypertension, diabetes mellitus, left ventricular ejection fraction, SYNTAX score, and chronic obstructive pulmonary disease (COPD). A total of 1858 patients were treated as assigned by randomization. Periprocedural MI occurred in 34/935 (3.6%) of patients in the PCI group and 56/923 (6.1%) of patients in the CABG group [odds ratio 0.61, 95% confidence interval (CI) 0.40-0.93; P = 0.02]. Periprocedural MI was associated with SYNTAX score, COPD, cross-clamp duration and total procedure duration, and not using antegrade cardioplegia. By multivariable analysis, PMI was associated with cardiovascular death and all-cause death at 3 years [adjusted hazard ratio (HR) 2.63, 95% CI 1.19-5.81; P = 0.02 and adjusted HR 2.28, 95% CI 1.22-4.29; P = 0.01, respectively]. The effect of PMI was consistent for PCI and CABG for cardiovascular death (Pinteraction = 0.56) and all-cause death (Pinteraction = 0.59). Peak post-procedure CK-MB ≥10× URL strongly predicted mortality, whereas lesser degrees of myonecrosis were not associated with prognosis. CONCLUSION: In the EXCEL trial, PMI was more common after CABG than PCI, and was strongly associated with increased 3-year mortality after controlling for potential confounders. Only extensive myonecrosis (CK-MB ≥10× URL) was prognostically important.

6.
Am Heart J ; 210: 49-57, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30738244

RESUMO

BACKGROUND: The prognostic impact of high-sensitivity C-reactive protein (CRP) levels in patients with left main coronary artery disease (LMCAD) treated with percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) is unknown. We sought to determine the effect of elevated baseline CRP levels on the 3-year outcomes after LMCAD revascularization and to examine whether CRP influenced the relative outcomes of PCI versus CABG. METHODS: In the EXCEL trial, patients with LMCAD and Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) scores ≤32 were randomized to PCI versus CABG. The primary composite outcome of death, myocardial infarction (MI), or stroke was analyzed according to baseline CRP levels. RESULTS: Among 999 patients with available CRP levels, median CRP was 3.10 mg/L (interquartile range 1.12-6.40 mg/L). The rate of the primary composite end point of death, MI, or stroke at 3 years steadily increased with greater baseline CRP levels. The adjusted relationship between the 3-year composite rate of death, MI, or stroke and baseline CRP modeled as a continuous log-transformed variable demonstrated steadily increasing event rates with greater CRP levels (adjusted hazard ratio, 1.26, 95% CI 1.10-1.44, P = .0008). Similarly, patients with CRP ≥10 mg/L had a 3-fold higher risk of the 3-year primary end point compared to patients with lower CRP levels (adjusted hazard ratio 2.92, 95% CI 1.88-4.54, P < .0001). The association between an elevated CRP level and the adjusted 3-year risk of the primary composite end point did not differ according to revascularization strategy (Pinteraction = .75). CONCLUSIONS: In patients with LMCAD undergoing revascularization, elevated baseline CRP levels were strongly associated with subsequent death, MI, and stroke at 3 years, irrespective of the mode of revascularization. Further studies are warranted to determine whether anti-inflammatory therapies may improve the prognosis of high-risk patients with LMCAD following revascularization.

7.
JACC Cardiovasc Interv ; 11(21): 2207-2216, 2018 Nov 12.
Artigo em Inglês | MEDLINE | ID: mdl-30409278

RESUMO

OBJECTIVES: The aim of this study was to further evaluate clinical outcomes in patients with and without PCS. BACKGROUND: Prior cardiac surgery (PCS) is associated with increased surgical risk and post-operative complications following surgical aortic valve replacement (SAVR), but whether this risk is similar in transcatheter aortic valve replacement (TAVR) is unclear. METHODS: In the PARTNER 2A (Placement of Aortic Transcatheter Valve) trial, 2,032 patients with severe aortic stenosis at intermediate surgical risk were randomized to TAVR with the SAPIEN XT valve or SAVR. Adverse clinical outcomes at 30 days and 2 years were compared using Kaplan-Meier event rates and multivariate Cox proportional hazards regression models. The primary endpoint of the PARTNER 2 trial was all-cause death and disabling stroke. RESULTS: Five hundred nine patients (25.1%) had PCS, mostly (98.2%) coronary artery bypass grafting. There were no significant differences between TAVR and SAVR in patients with or without PCS in the rates of the primary endpoint at 30 days or 2 years. Nevertheless, an interaction was observed between PCS and treatment arm; whereas no-PCS patients treated with TAVR had higher rates of 30-day major vascular complications than patients treated with SAVR (adjusted hazard ratio: 2.66; 95% confidence interval: 1.68 to 4.22), the opposite was true for patients with PCS (adjusted hazard ratio: 0.27; 95% confidence interval: 0.11 to 0.66) (pinteraction <0.0001). A similar interaction was observed for life-threatening or disabling bleeding. CONCLUSIONS: In the PARTNER 2A trial of intermediate-risk patients with severe aortic stenosis undergoing SAVR versus TAVR, the relative risk for 2-year adverse clinical outcomes was similar between TAVR and SAVR in patients with or without PCS.

8.
Artigo em Inglês | MEDLINE | ID: mdl-30489011

RESUMO

OBJECTIVES: We aimed to evaluate the safety and efficacy of the dedicated Tryton side branch (SB) stent for the treatment of true bifurcations involving large SBs. BACKGROUND: Bifurcation lesions are associated with lower procedural success and a higher risk of adverse cardiac events. Provisional stenting (PS) is currently the default approach for the treatment of bifurcation lesions. The Tryton stent is a dedicated bifurcation stent system for the treatment of true bifurcation lesions. METHODS: We performed an individual-patient-data pooled post-hoc analysis of the Tryton Pivotal randomized controlled trial and post-approval Confirmatory Study. Only patients with true bifurcations involving a SB ≥ 2.25 mm in diameter were included. The primary endpoint was non-inferiority of Tryton compared with PS for target vessel failure (TVF) at 1 year. RESULTS: Of the 411 patients meeting the criteria for enrolment, 287 patients were treated with the Tryton stent and 124 with PS. Procedural success was higher in the Tryton group (95.4 versus 82.3%, P < 0.0001). TVF at 1 year was 8.1% in the Tryton group and 9.7% in the PS group, meeting the pre-specified criteria for non-inferiority established for the randomized controlled trail (pnon-inferiority = 0.02). At 9-month angiographic follow-up, SB diameter stenosis was significantly lower in the Tryton group (29.3 ± 21.9 versus 41.1 ± 17.5, P = 0.0008) and in-segment binary restenosis (diameter stenosis ≥ 50%) was higher in the PS group (19.0 versus 34.2%, respectively, P = 0.052). CONCLUSIONS: In patients with true bifurcations involving a large SB, treatment with the Tryton SD Stent was clinically non-inferior to PS and showed favorable angiographic outcomes.

9.
Artigo em Inglês | MEDLINE | ID: mdl-30165487

RESUMO

OBJECTIVES: Observational data suggest that the use of a single internal thoracic artery (SITA) may result in inferior outcomes compared with bilateral internal thoracic artery (BITA) use for coronary artery bypass grafting (CABG)-a finding not yet supported by randomized trial outcomes. However, the optimal number of internal thoracic artery grafts in patients with left main coronary artery disease has not been investigated. METHODS: The EXCEL trial randomized 1905 patients with left main coronary artery disease to percutaneous coronary intervention with everolimus-eluting stents versus CABG. Among the 905 patients undergoing CABG, 688 (76.0%) received SITA and 217 (24.0%) received BITA. Differences in clinical event rates were estimated using the Kaplan-Meier method and compared with the log-rank test. Multivariable Cox regression was used to adjust for differences in baseline covariates. RESULTS: Compared to SITA, patients treated with BITA were younger (66.1 ± 9.5 vs 64.5 ± 9.3 years, P = 0.020), were less likely female (24.3% vs 14.3%, P = 0.002) and diabetic (28.8% vs 15.2%, P < 0.001), and had a lower prevalence of peripheral vessel disease (10.2% vs 5.5%, P = 0.040). The unadjusted 3-year composite primary endpoint of death, stroke or myocardial infarction (MI) occurred in 15.6% of SITA vs 11.6% of BITA patients (P = 0.17). The SITA group tended to have a higher 3-year rate of all-cause death compared with the BITA group (6.7% vs 3.3%; P = 0.070). Stroke, MI and ischaemia-driven revascularization outcomes were not significantly different between groups. After adjusting for baseline differences, neither the composite of death, stroke or MI [hazard ratio (HR) 1.12, 95% confidence interval (CI) 0.71-1.78; P = 0.62] nor mortality (HR 1.36, 95% CI 0.60-3.12; P = 0.46) was significantly higher with SITA. The rehospitalization rate after 3 years was higher in the SITA group (35.8% vs 26.0%, P = 0.008), a difference which was no longer present after multivariable adjustment (HR 1.27, 95% CI 0.93-1.74; P = 0.13). Sternal wound dehiscence within 30 days did not occur more often in the BITA group compared to the SITA group (1.8% vs 2.2%, P > 0.99). CONCLUSIONS: In the EXCEL trial, there were no clinical differences at 3 years between SITA or BITA revascularization in patients with left main coronary artery disease.

10.
Circ Cardiovasc Interv ; 11(7): e006488, 2018 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-30006331

RESUMO

BACKGROUND: Despite advances in technology and technique, a substantial proportion of patients still die within several years after percutaneous coronary intervention (PCI). The relative rates of cardiovascular and noncardiovascular death after PCI remain uncertain. METHODS AND RESULTS: We pooled individual patient-level data from 21 randomized clinical trials of PCI performed in 32 882 patients. All studies had independent adjudication of clinical events. We calculated the relative ratio of cardiovascular to noncardiovascular death in each trial up to 5 years and identified predictors of all-cause, cardiovascular, and noncardiovascular death. At the end of the follow-up period, 1980 patients had died (Kaplan-Meier estimated mortality rate, 9.19%). The rates of cardiovascular and noncardiovascular mortality at 5 years were 4.23% (945) and 5.17% (1035), respectively. The rate of cardiovascular death was higher than noncardiovascular death in the first 30 days after PCI (relative ratio, 6.99; 95% confidence interval, 3.16-15.42; P<0.001), similar between 30 days and 1 year, and lower between 1 and 5 years (relative ratio, 0.70; 95% confidence interval, 0.58-0.84; P=0.0005). Any adverse cardiac event (definite stent thrombosis, spontaneous myocardial infarction, or repeat revascularization) preceded cardiovascular and noncardiovascular mortality in 292 (30.9%) and 151 (14.6%) patients, respectively. In a multivariable model with adverse events entered as time-adjusted covariates, myocardial infarction and definite ST were associated with early and late all-cause and cardiovascular mortality but not noncardiovascular mortality. CONCLUSIONS: In this large-scale study of patients undergoing PCI, the 5-year rates of cardiovascular and noncardiovascular mortality were similar, but their relative timing was different.

11.
JACC Cardiovasc Interv ; 11(12): 1154-1160, 2018 Jun 25.
Artigo em Inglês | MEDLINE | ID: mdl-29929637

RESUMO

OBJECTIVES: The aim of this study was to assess the implications of concomitant tricuspid regurgitation (TR) in patients undergoing valve-in-valve (VIV) transcatheter aortic valve replacement. BACKGROUND: Patients undergoing VIV transcatheter aortic valve replacement with concomitant TR may have worse outcomes, and optimal management remains undetermined. METHODS: The multicenter PARTNER 2 (Placement of Aortic Transcatheter Valves) VIV trial enrolled patients with symptomatic degenerated surgical aortic bioprostheses who were at high risk for reoperation. Outcomes were assessed between patients with mild or no TR versus moderate or severe TR. RESULTS: A total of 237 patients underwent VIV procedures (mean age 78.7 ± 10.8 years, mean Society of Thoracic Surgeons score 9.1 ± 4.8%). In this cohort, 162 patients (68.4%) had mild or no TR, and 75 patients (31.6%) had moderate or severe TR. Although there was no difference in New York Heart Association functional class III or IV symptomatic status (89.3% vs. 91.4%; p = 0.62) or moderate or severe right ventricular dysfunction (9.4% vs. 16.9%; p = 0.11), patients with moderate or severe TR were more likely to be at high surgical risk, with a Society of Thoracic Surgeons score of >8 (62.7% vs 46.9%; p = 0.02). There was no difference in a composite endpoint of death and rehospitalization between moderate or severe TR and mild or no TR, either at 30 days (10.7% vs. 9.9%; p = 0.85) or at 1-year follow-up (24.1% vs. 23.2%; p = 0.80). There was a significant reduction in overall moderate or severe TR from baseline at 30 days (31.1% vs. 21.1%; p = 0.002), which was sustained at 1-year follow-up (38.0% vs. 22.8%; p = 0.004). CONCLUSIONS: Despite higher predicted surgical risk, the presence of TR was not a predictor of long-term outcomes. Importantly, there was significant reduction in TR severity at both short- and long-term follow-up. In selected patients undergoing VIV transcatheter aortic valve replacement, it may be appropriate to conservatively manage concomitant TR.

12.
EuroIntervention ; 14(7): 806-814, 2018 Sep 20.
Artigo em Inglês | MEDLINE | ID: mdl-29790478

RESUMO

AIMS: Randomised controlled trials have reported instantaneous wave-free ratio (iFR) to be non-inferior to fractional flow reserve (FFR) for major adverse cardiovascular events at one year; however, iFR is limited by sensitive landmarking of the pressure waveform, and the assumption that maximal flow and minimal resistance occur during a fixed period of diastole. We sought to validate the resting full-cycle ratio (RFR), a novel non-hyperaemic index of coronary stenosis severity based on unbiased identification of the lowest distal coronary pressure to aortic pressure ratio (Pd/Pa), independent of the ECG, landmark identification, and timing within the cardiac cycle. METHODS AND RESULTS: VALIDATE-RFR was a retrospective study designed to derive and validate the RFR. The primary endpoint was the agreement between RFR and iFR. RFR was retrospectively determined in 651 waveforms in which iFR was measured using a proprietary Philips/Volcano wire. RFR was highly correlated to iFR (R2=0.99, p<0.001), with a mean bias of -0.002 (95% limits of agreement -0.023 to 0.020). The diagnostic performance of RFR versus iFR was diagnostic accuracy 97.4%, sensitivity 98.2%, specificity 96.9%, positive predictive value 94.5%, negative predictive value 99.0%, area under the receiver operating characteristic curve of 0.996, and diagnostically equivalent within 1% (mean difference -0.002; 95% CI: -0.009 to 0.006, p=0.03). The RFR was detected outside diastole in 12.2% (341/2,790) of all cardiac cycles and 32.4% (167/516) of cardiac cycles in the right coronary artery where the sensitivity of iFR compared to FFR was lowest (40.6%). CONCLUSIONS: RFR is diagnostically equivalent to iFR but unbiased in its ability to detect the lowest Pd/Pa during the full cardiac cycle, potentially unmasking physiologically significant coronary stenoses that would be missed by assessment dedicated to specific segments of the cardiac cycle.

13.
Circulation ; 2018 Apr 17.
Artigo em Inglês | MEDLINE | ID: mdl-29666071

RESUMO

Background -Elevated B-type natriuretic peptide (BNP) is reflective of impaired cardiac function and is associated with worse prognosis among patients with coronary artery disease (CAD). We sought to assess the association between baseline BNP, adverse outcomes, and the relative efficacy of percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG) in patients with left main (LM) CAD. Methods -The EXCEL trial randomized patients with LMCAD and low or intermediate SYNTAX scores to PCI with everolimus-eluting stents versus CABG. The primary endpoint was the composite of all-cause death, myocardial infarction (MI) or stroke. We used multivariable Cox proportional hazards regression to assess the associations between normal versus elevated BNP (≥100 pg/mL), randomized treatment, and the 3-year risk of adverse events. Results -BNP at baseline was elevated in 410 of 1037 (39.5%) patients enrolled in EXCEL. Patients with elevated BNP levels were older and more frequently had additional cardiovascular risk factors and lower LVEF than those with normal BNP, but had similar SYNTAX scores. Patients with elevated BNP had significantly higher 3-year rates of the primary endpoint (18.6% vs. 11.7%, adjusted HR 1.62, 95% CI 1.16-2.28, P=0.005), and higher mortality (11.5% vs. 3.9%, adjusted HR 2.49, 95% CI 1.48-4.19, P=0.0006), both from cardiovascular and non-cardiovascular causes. In contrast, there were no significant differences in the risks of MI, stroke, ischemia-driven revascularization, stent thrombosis, graft occlusion, or major bleeding. A significant interaction (Pinteraction=0.03) was present between elevated versus normal BNP and treatment with PCI versus CABG for the adjusted risk of the primary composite endpoint at 3 years among patients with elevated BNP (adjusted HR for PCI versus CABG 1.54, 95% CI 0.96-2.47) versus normal BNP (adjusted HR 0.74, 95% CI 0.46-1.20). This interaction was stronger when log(BNP) was modeled as a continuous variable (Pinteraction=0.002). Conclusions -In the EXCEL trial, elevated baseline BNP levels in patients with LMCAD undergoing revascularization were independently associated with long-term mortality but not non-fatal adverse ischemic or bleeding events. The relative long-term outcomes after PCI vs. CABG for revascularization of LMCAD may be conditioned by the baseline BNP level. Clinical Trial Registration -URL: http://www.clinicaltrials.gov. Unique identifier: NCT01205776.

14.
Int J Cardiol ; 253: 20-24, 2018 02 15.
Artigo em Inglês | MEDLINE | ID: mdl-29306465

RESUMO

BACKGROUND: QRS fragmentation (fQRS) is believed to reflect myocardial scar formation in patients with coronary disease. Whether early formation of fQRS in patients with ST-segment elevation myocardial infarction (STEMI) treated with percutaneous coronary intervention (PCI) is correlated with infarct size and prognosis is unknown. We assessed the prognostic value of fQRS at 60min post-PCI and its correlation with infarct size in patients with anterior STEMI managed with primary PCI. METHODS: The INFUSE-AMI trial enrolled 452 patients with anterior STEMI undergoing primary PCI. Electrocardiograms (ECGs) were performed at baseline and 60min post-PCI. Infarct size was evaluated using cardiac magnetic resonance imaging at 30days post-PCI. Target vessel failure (TVF) was defined as the composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target vessel revascularization. Study groups were defined as patients with versus without fQRS at 60min post-PCI. RESULTS: Out of 421 patients with ECG data 60min post-PCI, 68 patients (16.2%) had fQRS. Patients with versus without fQRS had similar baseline characteristics and infarct size (16.9%±8.7% vs. 16.1%±10.5%, p=0.62), but patients with fQRS had higher adjusted risk of 1-year TVF (adjusted HR 2.27, 95% CI 1.06-4.89, p=0.036) and a trend toward a higher risk of the composite cardiac death or target vessel myocardial infarction (9.0% vs. 4.1%, p=0.08) at 1year. CONCLUSION: fQRS in patients with STEMI is associated with TVF but does not correlate with infarct size.


Assuntos
Eletrocardiografia/métodos , Intervenção Coronária Percutânea/métodos , Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico por imagem , Infarto do Miocárdio com Supradesnível do Segmento ST/fisiopatologia , Idoso , Angiografia Coronária/métodos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Prognóstico , Infarto do Miocárdio com Supradesnível do Segmento ST/cirurgia , Método Simples-Cego , Resultado do Tratamento
15.
JACC Cardiovasc Interv ; 11(1): 13-20, 2018 Jan 08.
Artigo em Inglês | MEDLINE | ID: mdl-29301644

RESUMO

OBJECTIVES: The purpose of this study was to identify sex-specific outcomes of intermediate risk patients undergoing transcatheter aortic valve replacement with the SAPIEN 3 valve. BACKGROUND: A survival difference has been observed in women as compared with men in inoperable and high-risk patients receiving early-generation balloon-expandable valves for transcatheter aortic valve replacement (TAVR). Whether a sex-specific outcome difference persists with newer-generation valves and in lower-risk patients is unknown. METHODS: The PARTNER (Placement of Aortic Transcatheter Valves) II S3 trial included high-risk (HR) (Society of Thoracic Surgeons risk score >8% or heart team determination) and intermediate-risk (IR) (Society of Thoracic Surgeons risk score 4% to 8% or heart team determination) patients with severe symptomatic aortic stenosis who were treated with TAVR with the SAPIEN 3 valve. Patient characteristics and clinical outcomes at 30 days and 1 year were compared by sex. RESULTS: Between October 2013 and December 2014, 1,661 patients were enrolled: 583 were HR (338 men, 245 women) and 1,078 were IR (666 men, 412 women). In both cohorts, women were more likely than men to be frail (22% vs. 13%; p < 0.001), but less likely to have comorbid conditions of renal insufficiency, coronary artery disease, atrial fibrillation, or chronic obstructive pulmonary disease. Women were more likely to receive ≤23-mm valves (74.1% vs. 11.1%; p < 0.001) and were less likely to receive 29-mm valves (1.4% vs. 35.1%; p < 0.001). In the combined cohorts, there was no difference in mortality for women compared with men at 30 days (2.0% vs. 1.2%; p = 0.20) or 1 year (9.3% vs. 10.2%; p = 0.59). There were no differences in disabling stroke or any stroke at 30 days or 1 year; however, women had an increased rate of minor stroke at 30 days (2.1% vs. 0.7%; p = 0.01). Female sex was associated with increased major vascular complications (7.9% vs. 4.4%; p = 0.003), but not with moderate or severe paravalvular regurgitation. Notably, similar outcomes regarding sex-specific outcomes were obtained within stratified analyses of the HR and IR cohorts. CONCLUSIONS: The study found no apparent sex-specific differences in survival or stroke in this trial of TAVR. This may reflect the changing demographic of patients enrolled, use of newer-generation valves with more sizes available, and more accurate valve sizing techniques.

16.
Eur Heart J Acute Cardiovasc Care ; 7(4): 339-347, 2018 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-28828881

RESUMO

BACKGROUND: The determinants and significance of early (30-day) heart failure symptoms after primary percutaneous coronary intervention for ST-segment elevation myocardial infarction (STEMI) remain unclear. We investigated the clinical and imaging correlates of early post-discharge heart failure in patients with STEMI, and evaluated its impact on clinical outcomes. METHODS: Patients from the INFUSE-AMI trial were categorized according to New York Heart Association (NYHA) functional classification at their 30-day visit (NYHA class ≥2 versus 1). Independent correlates of NYHA class ≥2 were determined by multivariable logistic regression. A landmark analysis beyond 30 days was performed to assess the impact of 30-day NYHA class ≥2 on 1-year risk of death or hospitalization for heart failure. RESULTS: Among 402 patients enrolled in the INFUSE-AMI trial with data on NYHA class at 30 days, 76 (18.9%) had NYHA class ≥2. Independent correlates of 30-day NYHA class ≥2 were age, Killip class ≥2 at presentation, heart rate at presentation, intraprocedural no-reflow, and 30-day infarct size (% total ventricular mass). After adjustment for infarct size, patients with NYHA class ≥2 remained at higher risk of death or hospitalization for heart failure at 1-year follow-up compared to those in NYHA class 1 (11.8% vs. 2.8%, adjusted hazard ratio 3.78, 95% confidence interval 1.16-12.22, P=0.03). CONCLUSIONS: Clinical, procedural, and imaging variables predict the development of clinical heart failure after primary percutaneous coronary intervention in patients with STEMI. Early post-discharge heart failure symptoms identify a high-risk patient cohort for subsequent heart failure hospitalization and death, independent of infarct size. TRIAL REGISTRATION: ClinicalTrials.gov ; NCT00976521.


Assuntos
Insuficiência Cardíaca/etiologia , Intervenção Coronária Percutânea/efeitos adversos , Medição de Risco , Infarto do Miocárdio com Supradesnível do Segmento ST/cirurgia , Idoso , Áustria/epidemiologia , Causas de Morte/tendências , Angiografia Coronária , Eletrocardiografia , Feminino , Seguimentos , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/epidemiologia , Humanos , Incidência , Imagem Cinética por Ressonância Magnética , Masculino , Pessoa de Meia-Idade , Polônia/epidemiologia , Prognóstico , Estudos Prospectivos , Quebeque/epidemiologia , Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico , Infarto do Miocárdio com Supradesnível do Segmento ST/mortalidade , Método Simples-Cego , Taxa de Sobrevida/tendências , Fatores de Tempo , Estados Unidos/epidemiologia
17.
Echocardiography ; 35(2): 142-147, 2018 02.
Artigo em Inglês | MEDLINE | ID: mdl-29193376

RESUMO

BACKGROUND: In patients with severe aortic regurgitation (AR), the left ventricular ejection fraction (LVEF) and left ventricle (LV) size are crucial for determining clinical prognosis and timing of valve intervention. In clinical practice, LV internal diameters obtained at end-diastole are used to assess the degree of LV dilatation. Whether quantification of LV volumes would provide more robust information as compared to LV linear dimensions is unknown. METHODS: We retrospectively analyzed preoperative and postoperative transthoracic echocardiograms of patients who underwent aortic valve replacement (AVR) for severe AR. Indexed linear LV end-diastolic and end-systolic diameters along with indexed LV end-diastolic and end-systolic volumes were obtained as per current guidelines. Post-AVR LV reverse remodeling, defined as ≥10% reduction in measures of LV volumes (Teichholz and Simpson's methods), was determined. Positive and negative agreement was calculated between the volume- and diameter-based LV reverse remodeling. RESULTS: Sixty-two consecutive patients were included. Nine patients (17%) without LV reverse remodeling based on Teichholz were reclassified as having LV reverse remodeling based on Simpson (positive agreement 0.846 [95% CI 0.772, 0.921], negative agreement 0.200 [95% CI -0.350, 0.435]). Left ventricle (LV) reverse remodeling assessed by the Teichholz method was underestimated by a mean of 31 mL/m2 (ß = -0.65 [95% CI -1.06 to -0.24], P = .003) compared to Simpson method. CONCLUSION: Compared to the volume-based method, diameter-based LV measurement incorrectly identified LV reverse remodeling post-AVR in 17% of patients with severe AR. Left ventricle (LV) volume may be a better measure to assess LV remodeling post-AVR than LV diameter-based measurements.


Assuntos
Insuficiência da Valva Aórtica/fisiopatologia , Insuficiência da Valva Aórtica/cirurgia , Ecocardiografia/métodos , Implante de Prótese de Valva Cardíaca , Ventrículos do Coração/diagnóstico por imagem , Remodelação Ventricular/fisiologia , Valva Aórtica/fisiopatologia , Feminino , Próteses Valvulares Cardíacas , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos
18.
JACC Cardiovasc Interv ; 10(23): 2414-2422, 2017 Dec 11.
Artigo em Inglês | MEDLINE | ID: mdl-29217004

RESUMO

OBJECTIVES: The authors sought to evaluate the impact of transapical (TA) transcatheter aortic valve replacement (TAVR) on mortality, left ventricular (LV) ejection fraction (LVEF) improvement, and functional recovery in patients with LV dysfunction. BACKGROUND: LV injury inherent to TA access for structural heart disease interventions may be particularly detrimental to the LV, functional recovery, and survival in patients with LV dysfunction. METHODS: The study included patients enrolled within the PARTNER I (Placement of Aortic Transcatheter Valves) trial that underwent transfemoral (TF) or TA TAVR. Analyses of clinical outcomes were stratified by the presence of baseline LV dysfunction (LVEF<50%) and adjusted for the propensity of receiving TA TAVR. RESULTS: Of 2,084 subjects, 1,057 underwent TA TAVR. TA access was associated with increased 2-year all-cause mortality in those with (adjusted hazard ratio [HRadjusted]: 1.52; 95% confidence interval [CI]: 1.12 to 2.07; p = 0.008) and without (HRadjusted: 1.38; 95% CI: 1.10 to 1.74; p = 0.006) LV dysfunction. TA TAVR portended increased 2-year cardiac mortality in subjects with LVEF<50% (HRadjusted: 1.92; 95% CI: 1.21 to 3.05; p = 0.006), but not with LVEF≥50% (HRadjusted: 1.29; 95% CI: 0.87 to 1.90; p = 0.21). In those with LVEF<50%, greater improvements in LVEF (TF-TA difference +4.04%, 95% CI: 2.39% to 5.69%; p < 0.0001) and 6-min walk distance (TF-TA difference +45.1 m, 95% CI: 18.4 to 71.9 m; p = 0.001) occurred within 30 days after TF versus TA TAVR. CONCLUSIONS: Compared with TF TAVR, TA TAVR is associated with a disproportionate risk of cardiac mortality in patients with LV dysfunction and with delayed and less robust improvement in LV function and overall functional status. Caution is warranted when considering TA access for structural heart disease interventions, particularly in patients with LV dysfunction. (Placement of Aortic Transcatheter Valves [PARTNER]; NCT00530894).


Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Substituição da Valva Aórtica Transcateter/mortalidade , Disfunção Ventricular Esquerda/fisiopatologia , Função Ventricular Esquerda , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/mortalidade , Estenose da Valva Aórtica/fisiopatologia , Distribuição de Qui-Quadrado , Tomada de Decisão Clínica , Ecocardiografia , Feminino , Humanos , Estimativa de Kaplan-Meier , Modelos Lineares , Masculino , Pontuação de Propensão , Modelos de Riscos Proporcionais , Recuperação de Função Fisiológica , Sistema de Registros , Medição de Risco , Fatores de Risco , Índice de Gravidade de Doença , Volume Sistólico , Fatores de Tempo , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/métodos , Resultado do Tratamento , Disfunção Ventricular Esquerda/diagnóstico por imagem , Disfunção Ventricular Esquerda/mortalidade
19.
Int J Cardiol ; 248: 97-102, 2017 Dec 01.
Artigo em Inglês | MEDLINE | ID: mdl-28818353

RESUMO

BACKGROUND: Increasing coronary lesion calcification is thought to be associated with adverse percutaneous coronary intervention (PCI) and clinical outcomes. We investigated the effects of calcium burden on culprit lesion morphology and clinical events after intravascular ultrasound (IVUS)-guided PCI in the ADAPT-DES study. METHODS: ADAPT-DES was a prospective, multicenter registry of 8582 consecutive patients undergoing successful PCI using DES. A pre-specified virtual histology (VH)-IVUS substudy of 638 culprit lesions (638 patients) had both pre- and post-PCI VH-IVUS. We divided lesions into tertiles according to pre-PCI percent dense calcium volume (DCV%=dense calcium/plaque volume×100). RESULTS: Compared with low and intermediate DCV% tertiles, patients in the high DCV% tertile had the largest arc of superficial calcium, highest percentage of necrotic core volume, and smallest remodeling index; they were also more likely to have advanced lesion morphology such as attenuated plaque and VH thin-cap fibroatheromas. In the high DCV% tertile IVUS guidance was associated with a minimum stent area that was smaller than tertiles with less calcium (p=0.01), but acceptable range, and similar stent expansion (73.8±16.8% vs. 74.0±19.2% vs. 72.4±17.3%, p=0.62) after more frequent use of rotational atherectomy and higher maximum inflation pressure. There was no significant association between pre-PCI DCV% and 2-year target lesion revascularization or major adverse cardiac events (cardiac death, myocardial infarction, or stent thrombosis). CONCLUSIONS: Increasing coronary artery calcification burden was associated with more advanced, complex VH-IVUS lesion morphology, but not with adverse clinical outcomes, perhaps due to more aggressive PCI techniques that optimized stent expansion.


Assuntos
Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/terapia , Intervenção Coronária Percutânea/tendências , Sistema de Registros , Calcificação Vascular/diagnóstico por imagem , Calcificação Vascular/terapia , Idoso , Cálcio , Stents Farmacológicos/tendências , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Inibidores da Agregação de Plaquetas/uso terapêutico , Estudos Prospectivos
20.
JACC Cardiovasc Interv ; 10(15): 1578-1587, 2017 Aug 14.
Artigo em Inglês | MEDLINE | ID: mdl-28734891

RESUMO

OBJECTIVES: This study sought to determine if indexed effective orifice area (EOAi), using left ventricular outflow tract measured from computed tomography (EOAiCT), reclassified prosthesis-patient mismatch (PPM) compared with conventional echocardiogram-defined measurements (EOAiTTE). BACKGROUND: PPM does not predict mortality following transcatheter aortic valve replacement (TAVR). However, it is unknown if the EOAiCT of the left ventricular outflow tract improves risk stratification. METHODS: A total of 765 TAVR patients from the PARTNER II (Placement of Aortic Transcatheter Valves II) trial S3i cohort were evaluated. EOAi was calculated using the continuity equation, and the left ventricular outflow tract area was derived from baseline computed tomography. Traditional echocardiographic categories defined PPM: absent (>0.85 cm2/m2), moderate (≥0.65 and ≤0.85 cm2/m2), or severe (≤0.65 cm2/m2). Correlation of EOAiCT and EOAiTTE to 1-year outcomes was performed. RESULTS: The incidence of PPM was 24% with EOACT compared with 45% with EOAiTTE. Only 6% of PPM was graded severe by EOAiCT compared with 9% by EOAiTTE. EOAiTTE, but not EOAiCT, defined PPM showed association with reduced left ventricular mass regression (p = 0.03 vs. p = 0.52). There was no association between PPM and death or rehospitalization at 1 year with either modality. EOACT was associated with minor stroke at 1 year (log-rank p = 0.04), and EOAiTTE with stroke/transient ischemic attack (log-rank p = 0.030). Furthermore, when subjects with mild or greater paravalvular regurgitation were excluded, the presence of PPM did not show association with any outcome. CONCLUSIONS: EOAiCT downgrades frequency and severity of PPM in patients after TAVR, and was not associated with mortality 1 year after TAVR. EOAiTTE, but not EOAiCT, was associated with less left ventricular mass regression.


Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Próteses Valvulares Cardíacas , Complicações Pós-Operatórias/diagnóstico por imagem , Tomografia Computadorizada por Raios X , Substituição da Valva Aórtica Transcateter/instrumentação , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/mortalidade , Estenose da Valva Aórtica/fisiopatologia , Área Sob a Curva , Ecocardiografia Doppler , Feminino , Humanos , Hipertrofia Ventricular Esquerda/diagnóstico por imagem , Hipertrofia Ventricular Esquerda/fisiopatologia , Estimativa de Kaplan-Meier , Masculino , Complicações Pós-Operatórias/mortalidade , Complicações Pós-Operatórias/fisiopatologia , Complicações Pós-Operatórias/prevenção & controle , Valor Preditivo dos Testes , Desenho de Prótese , Curva ROC , Sistema de Registros , Reprodutibilidade dos Testes , Medição de Risco , Fatores de Risco , Índice de Gravidade de Doença , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/mortalidade , Resultado do Tratamento
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