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1.
J Invasive Cardiol ; 2021 Feb 18.
Artigo em Inglês | MEDLINE | ID: mdl-33600353

RESUMO

OBJECTIVES: To determine the occurrence of vascular complications (VCs) following transfemoral transcatheter aortic valve replacement (TAVR) with new-generation devices according to the use of a crossover technique (COT). BACKGROUND: The use of a COT (with/without balloon) has been associated with a reduction of VCs in TAVR patients. However, scarce data support its use with second-generation devices. Also, its potential benefit in obese patients (at high-risk of VCs) has not been elucidated. METHODS: A multicenter study including 2214 patients who underwent full percutaneous transfemoral TAVR (COT, 1522 patients; no COT, 692 patients). Thirty-day events were evaluated according to the use of a COT using a multivariate logistic regression model. A subanalysis was performed in obese patients. RESULTS: Primary access major VCs (3.5% COT vs 3.9% no COT; P=.19), major/life-threatening bleeding (3.4% COT vs 2.0% no COT; P=.33), and mortality rates (2.4% COT vs 2.6% no COT; P=.23) were similar between groups. However, minor VCs (11.7% COT vs 5.9% no COT; P<.001) and postprocedural acute renal failure (8.9% COT vs 3.9% no COT; P<.001) were higher in patients undergoing the COT. In the overall cohort, percutaneous closure device failure was more frequent in obese patients (4.0% in the obese group vs 1.9% in the non-obese group; P<.01), but these differences were no longer significant in those undergoing a COT (3.4% in the obese group vs 2.0% in the non-obese group; P=.12). Indeed, in the subset of obese patients, the COT tended to be associated with fewer VCs (3.4% COT vs 5.9% no COT; P=.09). CONCLUSIONS: The use of a COT was not associated with a reduction of major VCs or improved outcomes. However, some patient subsets, such as those with higher body mass index, may benefit from the use of a COT. These findings would suggest the application of a tailored strategy, following a risk-benefit assessment in each TAVR candidate.

2.
Artigo em Inglês | MEDLINE | ID: mdl-33539048

RESUMO

AIMS: We aimed to update the logistic clinical SYNTAX score to predict 2 year all-cause mortality after contemporary percutaneous coronary intervention (PCI). METHODS AND RESULTS: We analyzed 15,883 patients in the GLOBAL LEADERS study who underwent PCI. The logistic clinical SYNTAX model was updated after imputing missing values by refitting the original model (refitted original model) and fitting an extended new model (new model, with, selection based on the Akaike Information Criterion). External validation was performed in 10,100 patients having PCI at Fu Wai hospital. Chronic obstructive pulmonary disease, prior stroke, current smoker, hemoglobin level, and white blood cell count were identified as additional independent predictors of 2 year all-cause mortality and included into the new model. The c-indexes of the original, refitted original and the new model in the derivation cohort were 0.74 (95% CI 0.72-0.76), 0.75 (95% CI 0.73-0.77), and 0.78 (95% CI 0.76-0.80), respectively. The c-index of the new model was lower in the validation cohort than in the derivation cohort, but still showed improved discriminative ability of the newly developed model (0.72; 95% CI 0.67-0.77) compared to the refitted original model (0.69; 95% CI 0.64-0.74). The models overestimated the observed 2 year all-cause mortality of 1.11% in the Chinese external validation cohort by 0.54 percentage points, indicating the need for calibration of the model to the Chinese patient population. CONCLUSIONS: The new model of the logistic clinical SYNTAX score better predicts 2 year all-cause mortality after PCI than the original model. The new model could guide clinical decision making by risk stratifying patients undergoing PCI.

3.
Clin Cardiol ; 2021 Jan 19.
Artigo em Inglês | MEDLINE | ID: mdl-33465269

RESUMO

BACKGROUND: Acute coronary syndrome (ACS) remains one of the leading causes of mortality for women, increasing with age. There is an unmet need regarding this condition in a fast-growing and predominantly female population, such as nonagenarians. HYPOTHESIS: Our aim is to compare sex-based differences in ACS management and long-term clinical outcomes between women and men in a cohort of nonagenarians. METHODS: We included consecutive nonagenarian patients with ACS admitted at four academic centers between 2005 and 2018. The study was approved by the Ethics Committee of each center. RESULTS: A total of 680 nonagenarians were included (59% females). Of them, 373 (55%) patients presented with non-ST-segment elevation ACS and 307 (45%) with ST-segment elevation myocardial infarction (STEMI). Men presented a higher disease burden compared to women. Conversely, women were frailer with higher disability and severe cognitive impairment. In the STEMI group, women were less likely than men to undergo percutaneous coronary intervention (PCI) (60% vs. 45%; p = .01). Overall mortality rates were similar in both groups but PCI survival benefit at 1-year was greater in women compared to their male counterparts (82% vs. 68%; p = .008), persisting after sensitivity analyses using propensity-score matching (80% vs. 64%; p = .03). CONCLUSION: Sex-gender disparities have been observed in nonagenarians. Despite receiving less often invasive approaches, women showed better clinical outcomes. Our finding may help increase awareness and reduce the current gender gap in ACS management at any age.

4.
EuroIntervention ; 2021 Jan 12.
Artigo em Inglês | MEDLINE | ID: mdl-33433389

RESUMO

AIMS: To evaluate the efficacy of the new BioFreedom Ultra™ drug-coated stent with a thin-strut cobalt-chromium platform (BF-CoCr) compared to the BioFreedom™ drug-coated stent with a stainless-steel platform (BF-SS) in an all-comers population undergoing percutaneous coronary interventions (PCI). METHODS AND RESULTS: This was a prospective, multi-center, non-inferiority trial. The primary endpoint was in-stent late lumen loss (LLL) as determined by quantitative coronary angiographic at 9-month follow-up. Clinical evaluation was performed at 1 year. A total of 200 patients were randomized (1:1) to either the BF-CoCr or the BF-SS stent at 8 centers in Spain and Denmark. Baseline clinical and lesion characteristics were similar among the groups. Mean age was 66 years and 23% were females. The mean number of stents implanted per patient was 1.5. At 9-month follow-up, mean in-stent LLL was 0.34±0.49mm in BF-CoCr versus 0.29±0.37mm in the BF-SS, p=0.005 for non-inferiority. At 1-year, target lesion failure was similar between groups (7.3% in Bf-CoCr vs 9.3% in the BF-SS group; p=0.60). CONCLUSIONS: The BF-CoCr was non-inferior to the BF-SS in terms of in-stent LLL at 9 months. Larger studies powered for clinical endpoints are warranted to compare the efficacy of this new platform with currently available DES.

5.
J Invasive Cardiol ; 33(1): E2-E8, 2021 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-33385980

RESUMO

BACKGROUND: Chronic total occlusions (CTOs) are prevalent angiographic findings in patients with suspected coronary artery disease. Conflicting results of randomized controlled trials and registries have not clarified the therapeutic approach for patients with CTO in clinical practice. Therefore, we sought to analyze variables influencing the decision-making process and their relationship with clinical outcomes according to the type of selected therapy. METHODS: A total of 1248 consecutive patients with at least 1 CTO were identified between 2010 and 2014 at our institution. Clinical and angiographic variables were collected to allow the calculation of several predictive scores. Primary outcome was all-cause death at the longest follow-up available. Other endpoints of interest included cardiac mortality and myocardial infarction. Medical therapy (MT) alone was indicated in 719 patients (58%), whereas percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) were used in 240 (19%) and 298 (24%), respectively. Age, acute myocardial infarction, previous CABG, and age, creatinine, ejection fraction (ACEF) score were independently associated with the decision for MT alone. Conversely, the presence of multivessel disease, left main coronary artery involvement, and high SYNTAX score favored the decision for CABG. At a median follow-up of 4.3 years, revascularization strategies were independently associated with all-cause mortality and cardiac mortality (hazard ratio [HR], 0.42; 95% confidence interval [CI] 0.27-0.65; P<.001 and HR, 0.32; 95% CI, 0.17-0.60; P<.001, respectively) for PCI and (HR, 0.39; 95% CI, 0.26-0.58 and HR, 0.51; 95% CI, 0.32-0.81; P<.01, respectively) for CABG. CONCLUSION: Several clinical and angiographic parameters influence the decision-making process of patients with CTO. CTO revascularization with either PCI or CABG appeared to be associated with improved clinical outcomes at long-term follow-up as compared with MT alone.

7.
Artigo em Inglês | MEDLINE | ID: mdl-33160894

RESUMO

BACKGROUND/PURPOSE: Everolimus-eluting stents (EES) are established as latest generation drug eluting stents. However, optical coherence tomography (OCT) assessment of neointimal distribution after EES implantation is lacking. We aimed to assess the longitudinal neointimal distribution pattern after EES implantation using OCT. METHODS: Data from 3 prospective studies (HEAL-EES, REVER and RESERVOIR), including patients with EES implantation and OCT follow-up study, were merged. Analyzed stents were divided into 3 segments of equal length (distal, medial, proximal). Longitudinal neointimal distribution patterns were compared between the 3 segments using generalized estimating equation. Neointimal thickness (NIT), neointimal area obstruction, and uncovered or malapposed struts were analyzed. RESULTS: In total, 86 patients (92 lesions) were analyzed. Time of OCT follow-up was 9.0 ± 1.5 months. NIT was 101.7 ± 65.4 µm and neointimal obstruction area was 12.2 ± 7.6%. The number of assessed struts was the same in all three segments. NIT tended to be higher at the medial segment (108.8 ± 71.1 µm) compared to distal (103.0 ± 63.4 µm) and proximal (93.3 ± 61.1 µm) (p = 0.076). Neointimal area obstruction was significantly different between the 3 segments (12.4 ± 7.5% [distal], 13.1 ± 7.7% [medial], 11.1 ± 7.5% [proximal]; p = 0.037). In the proximal segment, there was a significantly higher frequency of uncovered struts compared to medial and distal segments (3.9% vs. 2.1% vs. 2.5%, p = 0.009). The distribution of malapposed struts was not significantly different. CONCLUSIONS: Distribution of neointimal hyperplasia seems to be different between stent segments, being higher in the medial segment as compared to proximal and distal. Whether this may reflect a response to local pre-interventional plaque burden centrally covered by the stent should be confirmed in a future study. MANUSCRIPT SUMMARY: As optical coherence tomography based assessment of neointimal distribution after everolimus-eluting stent implantation is lacking, we analyzed data of 86 patients (92 lesions) from 3 prospective trials to evaluate neointimal distribution in distal, medial and proximal stent segments. Neointimal hyperplasia seemed to be different between the three segments, with a higher burden in the medial stent segment. Whether this reflects a response to local pre-interventional plaque burden centrally covered by the stent should be confirmed in a future study.

8.
Artigo em Inglês | MEDLINE | ID: mdl-33175478

RESUMO

OBJECTIVES: To compare the predictive performances of the prewiring, postwiring MI-SYNTAX scores, prewiring, and postwiring Updated Logistic Clinical SYNTAX score (LCSS) for 2-year all-cause mortality post percutaneous coronary intervention (PCI) in ST-elevation myocardial infarction (STEMI) patients. BACKGROUND: In patients with STEMI and undergoing primary PCI, coronary stenosis(es) distal to the culprit lesion is often observed after the restoration of coronary flow. To address comprehensively the complex coronary anatomy in these patients, prewiring and postwiring MI-SYNTAX scores have been reported in the literature. Furthermore, to enable individualized risk estimation for long-term all-cause mortality, the Updated LCSS has been developed by combining the anatomical SYNTAX score and clinical factors. METHODS: In the randomized GLOBAL LEADERS trial, anatomical SYNTAX score analysis was performed by an independent angiographic corelab for the first 4,000 consecutive patients as a prespecified analysis; of these, 545 presented with STEMI. The efficacy of the mortality predictions of the four scores at 2 years were evaluated based on their discrimination and calibration abilities. RESULTS: Complete data was available in 512 patients (93.9%). When the patients were stratified into two groups based on the median of the scores, the prewiring and postwiring Updated LCSSs demonstrated that the high-score groups were associated with higher rates of 2-year all-cause mortality compared to the low-score groups (6.6 vs. 1.2%; log-rank p = .001 and 6.6 vs. 1.2%; log-rank p = .001, respectively). There were no statistically significant differences for predicting the mortality between the prewiring (area under the curve [AUC] 0.625), postwiring MI-SYNTAX score (AUC 0.614), prewiring (AUC 0.755), and postwiring Updated LCSS (AUC 0.757). In the integrated discrimination improvement (IDI), the prewiring MI-SYNTAX score had a better discrimination for the mortality than the postwiring MI-SYNTAX score (IDI -0.0082; p = .029). The four scores had acceptable calibration abilities for 2-year all-cause mortality. CONCLUSIONS: The prewiring Updated LCSS predicts long-term all-cause mortality with clearly useful discrimination and acceptable calibration. Since the postwiring MI-SYNTAX score does not improve mortality prediction, the prewiring MI-SYNTAX score may be preferred for the 2-year mortality prediction using the Updated LCSS.

9.
EuroIntervention ; 2020 Nov 10.
Artigo em Inglês | MEDLINE | ID: mdl-33164895

RESUMO

AIMS: To evaluate the impact of pulmonary ridge (PR) coverage on both clinical and imaging follow-up outcomes in patients undergoing left atrial appendage occlusion (LAAO). METHODS AND RESULTS: The study included consecutive patients with non-valvular atrial fibrillation who underwent LAAO with disc and lobe devices. Patients were classified in two groups according to the PR coverage. A total of 147 patients were included. Among them, PR was covered in 109 (74%) and uncovered in 38 (26%). Successful implantation was achieved in 98.6%. No differences in procedural outcomes were observed among groups. The rate of procedural major adverse events was 3% (only major bleedings and/or vascular access complications). No device embolization, cardiac tamponade or in-hospital mortality was observed. After a mean follow-up of 1.77±2.2 years, the annualized ischemic stroke and major bleeding rate was 1.3%/year and 6.5%/year respectively without differences among groups. At follow-up, patients with a covered PR presented a lower incidence of device related thrombosis (DRT) (1%) than those with uncovered PR (27%); p<0.001. In multivariable analysis, the presence of PR coverage emerged as an independent predictor of DRT. CONCLUSIONS: Pulmonary ridge coverage was associated with a lower incidence of DRT after LAAO. Procedural and follow-up clinical outcomes did not differ among covered-PR and uncovered-PR patients.

10.
EuroIntervention ; 2020 Oct 27.
Artigo em Inglês | MEDLINE | ID: mdl-33106225

RESUMO

AIMS: Cardiogenic shock (CGS) occurs in 6-10% of patients with acute coronary syndromes (ACS). Mortality has fallen over time from 80% to approximately 50% consequent on acute revascularization but plateaued since the 1990s. Once established, patients with CGS develop adverse compensatory mechanisms that contribute to the downwards spiral towards death, which becomes difficult to reverse. METHODS AND RESULTS: The "EURO SHOCK' trial will test the benefit or otherwise of mechanical cardiac support using veno-arterial extra-corporeal membrane oxygenation (VA-ECMO), initiated early after acute percutaneous coronary intervention (PCI) for CGS. The trial sets out to randomize 428 patients with CGS complicating ACS, following primary PCI (P-PCI), to either very early ECMO plus standard pharmacotherapy, or to standard pharmacotherapy alone. It will be conducted in 39 European centers. The primary endpoint is 30-day all-cause mortality with key secondary endpoints: 1) 12-month all-cause mortality or admission for heart failure, 2) 12-month all-cause mortality, 3) 12-month admission for heart failure. Cost-effectiveness analysis (including quality of life measures) will be embedded. Mechanistic and hypothesis-generating sub-studies will be undertaken. CONCLUSIONS: The EURO SHOCK trial will determine whether early initiation of VA-ECMO in patients presenting with ACS-CGS persisting after PCI, improves mortality and morbidity.

11.
Am J Cardiol ; 2020 Oct 13.
Artigo em Inglês | MEDLINE | ID: mdl-33065080

RESUMO

Patients undergoing staged percutaneous coronary intervention (SPCI) are exposed to extended duration of antiplatelet therapy, and a novel aspirin-free antiplatelet regimen after SPCI should be specifically evaluated among these patients. This is a prespecified substudy of the GLOBAL LEADERS which is a randomized, open-label trial, comparing an experimental regimen of 1-month dual antiplatelet therapy (DAPT; ticagrelor and aspirin) followed by 23-month ticagrelor monotherapy to a reference regimen of 12-month DAPT followed by 12-month aspirin monotherapy. Patients were stratified according to whether or not SPCI was performed. The impact of the timing of SPCI on clinical outcomes was also investigated. Of 15,968 randomized patients, 1,651 patients underwent SPCI within 3 months. These patients with SPCI had a significantly higher risk of bleeding and ischemic endpoints than those without SPCI. In patients undergoing SPCI, the primary endpoint (composite of all-cause death or new Q-wave myocardial infarction at 2 years) and secondary safety endpoint (Bleeding Academic Research Consortium [BARC]-defined bleeding 3 or 5) were similar in the 2 regimens. However, in patients presenting with acute coronary syndrome (ACS), the experimental regimen reduced a risk of BARC 3 or 5 bleeding (1.8% vs 4.5%; HR 0.387; 95% CI 0.179 to 0.836; p = 0.016). In patients undergoing SPCI later than 10 days after index procedure, this risk reduction was still prominent (0.8% vs 2.3%; HR 0.321; 95% CI 0.116 to 0.891; p = 0.029). In conclusion, patients undergoing SPCI are at high risk and may need special attention from clinicians. In ACS patients undergoing SPCI, a novel aspirin-free antiplatelet regimen appears to be associated with a lower bleeding risk than with standard DAPT.

12.
J Am Coll Cardiol ; 76(14): 1609-1621, 2020 Oct 06.
Artigo em Inglês | MEDLINE | ID: mdl-33004126

RESUMO

BACKGROUND: Varying definitions of procedural myocardial infarction (PMI) are in widespread use. OBJECTIVES: This study sought to determine the rates and clinical relevance of PMI using different definitions in patients with left main coronary artery disease randomized to percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG) surgery in the EXCEL (Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial. METHODS: The pre-specified protocol definition of PMI (PMIProt) required a large elevation of creatine kinase-MB (CK-MB), with identical threshold for both procedures. The Third Universal Definition of MI (types 4a and 5) (PMIUD) required lesser biomarker elevations but with supporting evidence of myocardial ischemia, different after PCI and CABG. For the PMIUD, troponins were used preferentially (available in 49.5% of patients), CK-MB otherwise. The multivariable relationship between each PMI type and 5-year mortality was determined. RESULTS: PMIProt occurred in 34 of 935 (3.6%) patients after PCI and 56 of 923 (6.1%) patients after CABG (difference -2.4%; 95% confidence interval [CI]: -4.4% to -0.5%; p = 0.015). The corresponding rates of PMIUD were 37 (4.0%) and 20 (2.2%), respectively (difference 1.8%; 95% CI: 0.2% to 3.4%; p = 0.025). Both PMIProt and PMIUD were associated with 5-year cardiovascular mortality (adjusted hazard ratio [HR]: 2.18 [95% CI: 1.13 to 4.23] and 2.87 [95% CI: 1.44 to 5.73], respectively). PMIProt was associated with a consistent hazard of cardiovascular mortality after both PCI and CABG (pinteraction = 0.86). Conversely, PMIUD was strongly associated with cardiovascular mortality after CABG (adjusted HR: 11.94; 95% CI: 4.84 to 29.47) but not after PCI (adjusted HR: 1.14; 95% CI: 0.35 to 3.67) (pinteraction = 0.004). Results were similar for all-cause mortality and with varying PMIUD biomarker definitions. Only large biomarker elevations (CK-MB ≥10× upper reference limit and troponin ≥70× upper reference limit) were associated with mortality. CONCLUSIONS: The rates of PMI after PCI and CABG vary greatly with different definitions. In the EXCEL trial, the pre-specified PMIProt was associated with similar hazard after PCI and CABG, whereas PMIUD was strongly associated with mortality after CABG but not after PCI. (EXCEL Clinical Trial [EXCEL]; NCT01205776).

14.
Atherosclerosis ; 312: 79-89, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-32979635

RESUMO

BACKGROUND AND AIMS: The impact of endothelial shear stress (ESS) on vessel remodeling in vessels implanted with bioresorbable scaffold (BRS) as compared to metallic drug-eluting stent (DES) remains elusive. The aim of this study was to determine whether the relationship between ESS and remodeling patterns differs in BRS from those seen in metallic DES at 3-year follow-up. METHODS: In the ABSORB II randomized trial, lesions were investigated by serial coronary angiography and intravascular ultrasound (IVUS). Three-dimensional reconstructions of coronary arteries post-procedure and at 3 years were performed. ESS was quantified using non-Newtonian steady flow simulation. IVUS cross-sections in device segment were matched using identical landmarks. RESULTS: Paired ESS calculations post-procedure and at 3 years were feasible in 57 lesions in 56 patients. Post-procedure, median ESS at frame level was higher in BRS than in DES, with marginal statistical significance (0.97 ± 0.48 vs. 0.75 ± 0.39 Pa, p = 0.063). In the BRS arm, vessel area and lumen area showed larger increases in the highest tercile of median ESS post-procedure as compared to the lowest tercile. In contrast, in DES, no significant relationship between median ESS post-procedure and remodeling was observed. In multivariate analysis, smaller vessel area, larger lumen area, higher plaque burden post-procedure, and higher median ESS post-procedure were independently associated with expansive remodeling in matched frames. Only in BRS, younger age was an additional significant predictor of expansive remodeling. CONCLUSIONS: In a subset of lesions with large plaque burden, shear stress could be associated with expansive remodeling and late lumen enlargement in BRS, while ESS had no impact on vessel dimension in metallic DES.

15.
EuroIntervention ; 2020 Sep 15.
Artigo em Inglês | MEDLINE | ID: mdl-32928717

RESUMO

AIMS: The purpose of the Multivessel TALENT trial is to compare clinical outcomes of novel SUPRAFLEX Cruz stent with those of SYNERGY stent in patients with three vessel disease (3VD) undergoing state-of-the-art percutaneous coronary intervention (PCI). METHODS AND RESULTS: In this prospective, randomized, 1:1 balanced, multi-center, open-label trial, 1550 patients with de novo 3VD without left main disease are assigned to the SUPRAFLEX Cruz or SYNERGY arm. The following treatment principles of the "best practice" PCI will be applied: Heart Team consensus based on SYNTAX Score II treatment recommendation, functional lesion evaluation by quantitative flow ratio (QFR), stent optimization by intravascular imaging, optimal pharmacological treatment and prasugrel monotherapy. The primary endpoint is a non-inferiority comparison of patient-oriented composite endpoint (POCE) of all-cause death, any stroke, any myocardial infarction, or any revascularization, at 12 months post-procedure. The powered secondary endpoint is a superiority comparison of vessel-oriented composite endpoint (VOCE) defined as vessel-related cardiovascular death, vessel-related myocardial infarction, or clinically and physiologically-indicated-target vessel revascularization, at 24 months. CONCLUSIONS: The Multivessel TALENT trial will be evaluating a novel treatment strategy for complex coronary artery disease with state-of-the-art PCI based on angiography-derived QFR with novel ultra-thin SUPRAFLEX Cruz stents, compared with the SYNERGY stents.

16.
Int J Cardiol ; 2020 Sep 28.
Artigo em Inglês | MEDLINE | ID: mdl-32991944

RESUMO

BACKGROUND: Optimal timing of antithrombotic therapy for patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI) is unclear. We analyzed the impact of pre-angioplasty administration of unfractionated heparin (UFH) on infarct-related artery (IRA) patency and mortality. METHOD: Multicenter prospective observational study of 3520 STEMI patients treated with PPCI from 2016 to 2018. Subjects were divided into four groups according to the elapsed time from heparin administration to PPCI: Group 1: Upon arrival at catheterization laboratory or ≤ 30 min (n = 800; 22.7%); Group 2: 31 to 60 min (n = 994; 28.2%); Group 3: 61 to 90 min (n = 1091; 31%); Group 4: >90 min (n = 635; 18%). IRA patency was defined as thrombolysis in myocardial infarction (TIMI) flow grade 2-3. Multivariate analyses assessed factors associated with IRA patency and both 30-day and 1-year mortality. RESULTS: UFH administration at STEMI diagnosis was an independent predictor of IRA patency especially when administered more than 60 min before the PPCI (OR 1.43; 95% CI 1.14-1.81), either an independent predictor of 30-day (HR 0.63; 95% CI 0.42-0.94) and 1-year (HR 0.57; 95% CI 0.41-0.80) mortality. The effect of UFH on IRA patency was higher when administered earlier from the symptom onset. CONCLUSION: UFH administration at STEMI diagnosis improves coronary reperfusion prior to PPCI and this benefit seems associated with superior clinical outcomes. The presented results highlight a time-dependent effectiveness of UFH, since its reported effect is greater the sooner UFH is administered after symptom onset.

17.
J Invasive Cardiol ; 32(8): 283-288, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32737263

RESUMO

OBJECTIVES: The crossover balloon occlusion technique (CBOT) facilitates primary access hemostasis in patients undergoing transfemoral transcatheter aortic valve replacement (TAVR). The CBOT is usually performed through the contralateral femoral artery. The aim of this study was to evaluate, in patients undergoing TAVR, the safety and feasibility of transradial CBOT using the new Oceanus balloon dilatation catheter (iVascular). METHODS: This multicenter study included 104 patients (mean age, 81 ± 7 years; 43% women) undergoing transfemoral TAVR. A modified CBOT through the radial artery was performed in all patients with the Oceanus balloon catheter. Data regarding transradial CBOT, balloon performance, vascular complications, and 30-day clinical events were recorded. RESULTS: Up to 21% of patients had a height >170 cm and 17% presented with severe aortic/iliofemoral tortuosity. The transradial CBOT (left radial 74%, right radial 26%) was performed using either the 140 cm Oceanus (37.5%) or the 200 cm Oceanus (62.5%) balloon catheter. The balloon reached the femoral artery in all patients, and balloon inflation achieved an appropriate vessel closure in 98%. There were no complications related to the balloon catheter, and only 1 patient (1.0%) suffered a minor vascular complication related to the secondary radial access. The 30-day rates of primary access major vascular complications and death were 3.8% and 1.9%, respectively. CONCLUSION: In patients undergoing transfemoral TAVR, transradial CBOT with the Oceanus balloon dilatation catheter was feasible and safe. A balloon length up to 200 cm allowed the use of this technique (from right or left radial access) in all patients regardless of patient height or the presence of a challenging vascular anatomy.

18.
Am Heart J ; 227: 111-117, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32739537

RESUMO

BACKGROUND: Complete revascularization in patients with an acute coronary syndrome and multivessel disease is superior compared to culprit-only treatment. However, it is unknown whether direct complete or staged complete revascularization should be pursued. METHODS: The BIOVASC study is an investigator-initiated, prospective, multicenter, randomized, 2-arm, international, open-label, noninferiority trial. We will randomize 1,525 patients 1:1 to immediate complete revascularization (experimental arm) or culprit-only plus staged complete revascularization (control arm). Patients will be enrolled in approximately 30 sites in Belgium, Italy, the Netherlands, and Spain. The primary end point is a composite of all-cause mortality, nonfatal myocardial infarction, any unplanned ischemia-driven revascularization (excluding staged procedures in the control arm at the predetermined time), and cerebrovascular events (MACCE) at 1 year post index procedure. CONCLUSIONS: The BIOVASC study aims to further refine the treatment algorithm for acute coronary syndrome patients with multivessel disease in terms of optimal timing for complete revascularization (Clinicaltrials.gov NCT03621501).


Assuntos
Síndrome Coronariana Aguda/tratamento farmacológico , Síndrome Coronariana Aguda/cirurgia , Stents Farmacológicos , Intervenção Coronária Percutânea , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Sirolimo/administração & dosagem , Implantes Absorvíveis , Estudos de Equivalência como Asunto , Humanos , Estudos Multicêntricos como Assunto , Polímeros , Estudos Prospectivos , Desenho de Prótese
19.
Transl Res ; 2020 Aug 22.
Artigo em Inglês | MEDLINE | ID: mdl-32835905

RESUMO

Right ventricle (RV) dysfunction is a main determinant of morbidity and mortality in postcapillary pulmonary hypertension (PH). However, currently there are not available therapies. Since reduced nitric oxide (NO) availability and cyclic guanylate monophosphate (cGMP) levels are central in this disease, therapies targeting the NO pathway might have a beneficial effect on RV performance. In this regard, sildenafil has shown contradictory results. Our objective was to evaluate the effect of sildenafil on RV performance in an experimental pig model of postcapillary PH induced by a fixed banding of the venous pulmonary confluent. Animals were evaluated by right heart catheterization and cardiac magnetic resonance before randomization and after 8 weeks on sildenafil (n = 8) or placebo (n = 8), and myocardial tissues were analyzed with histology and molecular biology. At the end of the study, animals receiving sildenafil showed better RV performance as compared with those on placebo (improvement in RV ejection fraction of 7.3% ± 5.8% versus -0.6% ± 5.0%, P= 0.021) associated with less apoptotic cells and gene expression related with reduced oxidative stress and increased anti-inflammatory activity in the myocardium. No differences were observed in pulmonary hemodynamics. In conclusion, in a translational large animal model of chronic postcapillary PH, sildenafil improved RV systolic function independently of afterload. Further research with pharmacological approaches able to manipulate the NO-cGMP axis are needed to confirm this potential cardioprotective effect.

20.
Artigo em Inglês | MEDLINE | ID: mdl-32771401

RESUMO

BACKGROUND: Chronic total occlusion (CTO) is common among patients with coronary artery disease. Very few studies have focused on outcomes of patients with CTO and reduced left ventricular ejection fraction (LVEF), according to treatment applied. The aim of our study was to determine the potential influence of the selected treatment on the prognosis in patients with CTO associated with reduced LVEF. METHODS: Between June 2010 and October 2013, all consecutive patients with at least one CTO and reduced LVEF (<40%) were enrolled. Major adverse cardiac events (MACE), defined as the composite of cardiac mortality or myocardial infarction (MI) and its individual components, were compared between three treatment groups: medical therapy (MT), percutaneous coronary intervention (PCI), and coronary bypass graft (CABG). RESULTS: In 256 included patients, the follow-up was 1129 ± 556 days. The incidence of MACE was 40% in the MT group, compared with PCI (20.3%) and CABG (16.7%); p < 0.001. All-cause and cardiac mortality were also higher in the MT group (40.7% and 33.3%, respectively) versus the PCI (21.9% and 15.6%) and CABG (11.9% and 9.5%) groups (p < 0.001 for both endpoints); MI rate did not differ among groups. In the adjusted multivariate analysis, CABG had lower MACE risk, compared with MT (HR = 0.39, 0.17-0.91; p = 0.029); successful PCI also trended toward lower risk of MACE, compared with MT. CONCLUSIONS: Patients with CTO and reduced LVEF treated with MT had a worse prognosis than those treated with revascularization (either CABG or PCI). Patients with an indication for CABG appeared to perform best during long-term follow-up.

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