ABSTRACT
BACKGROUND AND AIM: Elderly patients are at increased risk of hemorrhagic and thrombotic complications after an acute coronary syndrome (ACS). Frailty, comorbidities and low body weight have emerged as conditioning the prognostic impact of dual antiplatelet therapy (DAPT). The aim of the present study was to investigate the prognostic impact of body mass index (BMI) on clinical outcome among patients included in the Elderly-ACS 2 trial, a randomized, open-label, blinded endpoint study comparing low-dose (5 mg) prasugrel vs clopidogrel among elderly patients with ACS. METHODS AND RESULTS: Our population is represented by 1408 patients enrolled in the Elderly-ACS 2 trial. BMI was calculated at admission. The primary endpoint of this analysis was cardiovascular (CV) mortality. Secondary endpoints were all-cause death, recurrent MI, Bleeding Academic Research Consortium (BARC) type 2 or 3 bleeding, and re-hospitalization for cardiovascular reasons or stent thrombosis within 12 months after index admission. Patients were grouped according to median values of BMI (Subject(s)
Acute Coronary Syndrome/therapy
, Body Mass Index
, Clopidogrel/administration & dosage
, Non-ST Elevated Myocardial Infarction/therapy
, Percutaneous Coronary Intervention
, Platelet Aggregation Inhibitors/administration & dosage
, Prasugrel Hydrochloride/administration & dosage
, ST Elevation Myocardial Infarction/therapy
, Acute Coronary Syndrome/diagnostic imaging
, Acute Coronary Syndrome/mortality
, Age Factors
, Aged
, Aged, 80 and over
, Cause of Death
, Clopidogrel/adverse effects
, Comorbidity
, Female
, Frail Elderly
, Geriatric Assessment
, Hemorrhage/chemically induced
, Hemorrhage/mortality
, Humans
, Italy
, Male
, Non-ST Elevated Myocardial Infarction/diagnostic imaging
, Non-ST Elevated Myocardial Infarction/mortality
, Percutaneous Coronary Intervention/adverse effects
, Percutaneous Coronary Intervention/mortality
, Platelet Aggregation Inhibitors/adverse effects
, Prasugrel Hydrochloride/adverse effects
, Recurrence
, Risk Assessment
, Risk Factors
, ST Elevation Myocardial Infarction/diagnostic imaging
, ST Elevation Myocardial Infarction/mortality
, Time Factors
, Treatment Outcome
ABSTRACT
BACKGROUND: Elderly patients are at elevated risk of both ischemic and bleeding complications after an acute coronary syndrome and display higher on-clopidogrel platelet reactivity compared with younger patients. Prasugrel 5 mg provides more predictable platelet inhibition compared with clopidogrel in the elderly, suggesting the possibility of reducing ischemic events without increasing bleeding. METHODS: In a multicenter, randomized, open-label, blinded end point trial, we compared a once-daily maintenance dose of prasugrel 5 mg with the standard clopidogrel 75 mg in patients >74 years of age with acute coronary syndrome undergoing percutaneous coronary intervention. The primary end point was the composite of mortality, myocardial infarction, disabling stroke, and rehospitalization for cardiovascular causes or bleeding within 1 year. The study was designed to demonstrate superiority of prasugrel 5 mg over clopidogrel 75 mg. RESULTS: Enrollment was interrupted, according to prespecified criteria, after a planned interim analysis, when 1443 patients (40% women; mean age, 80 years) had been enrolled with a median follow-up of 12 months, because of futility for efficacy. The primary end point occurred in 121 patients (17%) with prasugrel and 121 (16.6%) with clopidogrel (hazard ratio, 1.007; 95% confidence interval, 0.78-1.30; P=0.955). Definite/probable stent thrombosis rates were 0.7% with prasugrel versus 1.9% with clopidogrel (odds ratio, 0.36; 95% confidence interval, 0.13-1.00; P=0.06). Bleeding Academic Research Consortium types 2 and greater rates were 4.1% with prasugrel versus 2.7% with clopidogrel (odds ratio, 1.52; 95% confidence interval, 0.85-3.16; P=0.18). CONCLUSIONS: The present study in elderly patients with acute coronary syndromes showed no difference in the primary end point between reduced-dose prasugrel and standard-dose clopidogrel. However, the study should be interpreted in light of the premature termination of the trial. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01777503.
Subject(s)
Acute Coronary Syndrome/mortality , Acute Coronary Syndrome/therapy , Clopidogrel/administration & dosage , Myocardial Infarction/mortality , Myocardial Infarction/therapy , Prasugrel Hydrochloride/administration & dosage , Aged , Aged, 80 and over , Clopidogrel/adverse effects , Disease-Free Survival , Female , Hemorrhage/chemically induced , Hemorrhage/mortality , Humans , Male , Percutaneous Coronary Intervention , Prasugrel Hydrochloride/adverse effects , Survival RateABSTRACT
BACKGROUND: In the first report from the MitraBridge registry, MitraClip as a bridge to heart transplantation (HTx) proved to be at 1-year an effective treatment strategy for 119 patients with advanced heart failure (HF) who were potential candidates for HTx. We aimed to determine if benefits of MitraClip procedure as a bridge-to-transplant persist up to 2-years. METHODS: By the end of the enrollment period, a total of 153 advanced HF patients (median age 59 years, left ventricular ejection fraction 26.9 ± 7.7%) with significant secondary mitral regurgitation, who were potential candidates for HTx and were treated with MitraClip as a bridge-to-transplant strategy, were included in the MitraBridge registry. The primary endpoint was the 2-year composite adverse events rate of all-cause death, first hospitalization for HF, urgent HTx or LVAD implantation. RESULTS: Procedural success was achieved in 89.5% of cases. Thirty-day mortality was 0%. At 2-year, Kaplan-Meier estimates of freedom from primary endpoint was 47%. Through 24 months, the annualized rate of HF rehospitalization per patient-year was 44%. After an overall median follow-up time of 26 (9-52) months, elective HTx was successfully performed in 30 cases (21%), 19 patients (13.5%) maintained or obtained the eligibility for transplant, and 32 patients (22.5%) no longer had an indication for HTx because of significant clinical improvement. CONCLUSIONS: After 2-years of follow-up, the use of MitraClip as a bridge-to-transplant was confirmed as an effective strategy, allowing elective HTx or eligibility for transplant in one third of patients, and no more need for transplantation in 22.5% of cases.
Subject(s)
Heart Failure , Heart Transplantation , Heart Valve Prosthesis Implantation , Mitral Valve Insufficiency , Humans , Middle Aged , Stroke Volume , Ventricular Function, Left , Time Factors , Heart Transplantation/adverse effects , Treatment Outcome , Mitral Valve Insufficiency/diagnostic imaging , Mitral Valve Insufficiency/surgery , Heart Failure/diagnosis , Heart Failure/surgery , Registries , Heart Valve Prosthesis Implantation/methodsABSTRACT
BACKGROUND: The optimal antiplatelet regimen in elective patients undergoing complex percutaneous coronary interventions (PCIs) is uncertain. We aimed to assess the impact of glycoprotein IIb/IIIa (GpIIb/IIIa) inhibition with eptifibatide in clinically stable subjects with diffuse coronary lesions. METHODS: Patients with stable coronary artery disease undergoing PCI by means of implantation of >33 mm of drug-eluting stent were single-blindedly randomized to heparin plus eptifibatide versus heparin alone. The primary end point was the rate of abnormal post-PCI creatine kinase-MB mass values. Secondary end points were major adverse cardiovascular events (MACEs) (ie, cardiac death, myocardial infarction, or urgent revascularization) and MACE plus bailout GpIIb/IIIa inhibitor use. RESULTS: The study was stopped for slow enrollment and funding issues after including a total of 91 patients: 44 were randomized to heparin plus eptifibatide, and 47, to heparin alone. Analysis for the primary end point showed a trend toward lower rates of abnormal post-PCI creatine kinase-MB mass values in the heparin-plus-eptifibatide group (18 [41%]) versus the heparin-alone group (26 [55%], relative risk 0.74 [95% CI 0.48-1.15], P = .169). Similar nonstatistically significant trends were found for rates of MACE, their components, or MACE plus bailout GpIIb/IIIa inhibitors (all P > .05). Notably, heparin plus eptifibatide proved remarkably safe because major bleedings or minor bleeding was uncommon and nonsignificantly different in both groups (all P > .05). CONCLUSIONS: Given its lack of statistical power, the INSTANT study cannot definitively provide evidence against or in favor of routine eptifibatide administration in stable patients undergoing implantation of multiple drug-eluting stent for diffuse coronary disease. However, the favorable trend evident for the primary end point warrants further larger randomized studies.
Subject(s)
Angioplasty, Balloon, Coronary/methods , Coronary Stenosis/therapy , Drug-Eluting Stents , Myocardial Infarction/prevention & control , Peptides/administration & dosage , Aged , Angioplasty, Balloon, Coronary/adverse effects , Angioplasty, Balloon, Coronary/mortality , Coronary Angiography/methods , Coronary Stenosis/diagnostic imaging , Coronary Stenosis/mortality , Eptifibatide , Female , Follow-Up Studies , Heparin/administration & dosage , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Myocardial Infarction/pathology , Platelet Aggregation Inhibitors/administration & dosage , Proportional Hazards Models , Risk Assessment , Severity of Illness Index , Single-Blind Method , Statistics, Nonparametric , Survival Analysis , Treatment OutcomeABSTRACT
Hemoglobin (Hb) levels have emerged as a useful tool for risk stratification and the prediction of outcome after myocardial infarction. We aimed at evaluating the prognostic impact of this parameter among patients in advanced age, where the larger prevalence of anemia and the higher rate of comorbidities could directly impact on the cardiovascular risk. METHODS: All the patients in the ELDERLY-2 trial, were included in this analysis and stratified according to the values of hemoglobin at admission. The primary endpoint of this study was cardiovascular mortality within one year. The secondary endpoints were all-cause mortality, MI, Bleeding Academic Research Consortium (BARC) type 2-3 or 5 bleeding, any stroke, re-hospitalization for cardiovascular event or stent thrombosis (probable or definite) within 12 months after index admission. RESULTS: We included in our analysis 1364 patients, divided in quartiles of Hb values (<12.2; 12.2-13.39; 13.44-14.49; ≥ 4.5 g/dl). At a mean follow- up of 330.4 ± 99.9 days cardiovascular mortality was increased in patients with lower Hb (HR[95%CI] = 0.76 [0.59-0.97], p = 0.03). Results were no more significant after correction for baseline differences (adjusted HR[95%CI] = 1.22 [0.41-3.6], p = 0.16). Similar results were observed for overall mortality. At subgroup analysis, (according to Hb median values) a significant interaction was observed only with the type of antiplatelet therapy, but not with major high-risk subsets of patients. CONCLUSIONS: Among elderly patients with acute coronary syndrome managed invasively, lower hemoglobin at admission is associated with higher cardiovascular and all-cause mortality and major ischemic events, mainly explained by the higher risk profile.
Subject(s)
Acute Coronary Syndrome , Percutaneous Coronary Intervention , Acute Coronary Syndrome/diagnosis , Acute Coronary Syndrome/drug therapy , Aged , Clopidogrel , Hemorrhage/epidemiology , Hospitalization , Humans , Percutaneous Coronary Intervention/adverse effects , Platelet Aggregation Inhibitors , Prasugrel Hydrochloride , Treatment OutcomeABSTRACT
BACKGROUND: Worse outcomes have been reported for women, compared with men, after an acute coronary syndrome (ACS). Whether this difference persists in elderly patients undergoing similar invasive treatment has not been studied. We investigated sex-related differences in 1-year outcome of elderly acute coronary syndrome patients treated by percutaneous coronary intervention (PCI). METHODS: Patients 75 years and older successfully treated with PCI were selected among those enrolled in 3 Italian multicenter studies. Cox regression analysis was used to assess the independent predictive value of sex on outcome at 12-month follow-up. RESULTS: A total of 2035 patients (44% women) were included. Women were older and most likely to present with ST-elevation myocardial infarction (STEMI), diabetes, hypertension, and renal dysfunction; men were more frequently overweight, with multivessel coronary disease, prior myocardial infarction, and revascularizations. Overall, no sex disparity was found about all-cause (8.3% vs 7%, P = .305) and cardiovascular mortality (5.7% vs 4.1%, P = .113). Higher cardiovascular mortality was observed in women after STEMI (8.8%) vs 5%, P = .041), but not after non ST-elevation-ACS (3.5% vs 3.7%, P = .999). A sensitivity analysis excluding patients with prior coronary events (N = 1324, 48% women) showed a significantly higher cardiovascular death in women (5.4% vs 2.9%, P = .025). After adjustment for baseline clinical variables, female sex did not predict adverse outcome. CONCLUSIONS: Elderly men and women with ACS show different clinical presentation and baseline risk profile. After successful PCI, unadjusted 1-year cardiovascular mortality was significantly higher in women with STEMI and in those with a first coronary event. However, female sex did not predict cardiovascular mortality after adjustment for the different baseline variables.
Subject(s)
Acute Coronary Syndrome , Percutaneous Coronary Intervention , Risk Assessment , Sex Factors , Acute Coronary Syndrome/diagnosis , Acute Coronary Syndrome/mortality , Acute Coronary Syndrome/surgery , Aged , Female , Humans , Hypertension/epidemiology , Italy/epidemiology , Male , Mortality , Overweight/epidemiology , Percutaneous Coronary Intervention/methods , Percutaneous Coronary Intervention/statistics & numerical data , Prognosis , Risk Assessment/methods , Risk Assessment/statistics & numerical data , Risk Factors , ST Elevation Myocardial Infarction/diagnosis , ST Elevation Myocardial Infarction/epidemiology , Severity of Illness IndexABSTRACT
OBJECTIVES: The aim of this study was to assess the characteristics, predictors, evolution, and neurocognitive effects of silent cerebral ischemic lesions (SCILs). BACKGROUND: Most patients undergoing transcatheter aortic valve replacement (TAVR) develop SCILs detectable on magnetic resonance imaging (MRI). The natural history and clinical relevance of SCILs are not well established. METHODS: Cerebral MRI was performed within 7 days before TAVR to assess baseline status and age-related white matter change score. MRI was repeated post-operatively to assess the occurrence, location, number, and dimensions of SCILs. Patients developing SCILs underwent a third MRI examination at 3- to 5-month follow-up. A neurocognitive evaluation was performed before TAVR, at discharge, and at 3-month follow-up. RESULTS: Of the 117 patients enrolled, 96 underwent post-procedural MRI; SCILs were observed in 76% of patients, distributed in all vascular territories, with a median number of 2 lesions, a median diameter of 4.5 mm, and a median total volume of 140 mm3. Independent predictors of SCIL occurrence were higher baseline age-related white matter change score and the use of self-expanding or mechanically expanded bioprostheses. Among 47 patients who underwent follow-up MRI, only 26.7% of post-procedural SCILs evolved into gliotic scar. SCIL occurrence was associated with a more pronounced transient neurocognitive decline early after TAVR and with lower recovery at follow-up. CONCLUSIONS: SCILs occur in the vast majority of patients undergoing TAVR and are predicted by more diffuse white matter damage at baseline and by the use of non-balloon-expandable prostheses. Although most SCILs disappear within months, their occurrence has a limited but significant impact on neurocognitive function.
Subject(s)
Aortic Valve Stenosis/surgery , Cognition , Intracranial Embolism/etiology , Neurocognitive Disorders/etiology , Transcatheter Aortic Valve Replacement/adverse effects , Aged , Aged, 80 and over , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/mortality , Asymptomatic Diseases , Databases, Factual , Female , Humans , Intracranial Embolism/diagnostic imaging , Italy , Magnetic Resonance Imaging , Male , Neurocognitive Disorders/diagnosis , Neurocognitive Disorders/psychology , Neuropsychological Tests , Prospective Studies , Risk Assessment , Risk Factors , Time Factors , Treatment OutcomeABSTRACT
BACKGROUND: Patients awaiting heart transplantation (HTx) often need bridging therapies to reduce worsening and progression of underlying disease. Limited data are available regarding the use of the MitraClip procedure in secondary mitral regurgitation for this clinical condition. METHODS: We evaluated an international, multicenter (17 centers) registry including 119 patients (median age: 58 years) with moderate-to-severe or severe secondary mitral regurgitation and advanced heart failure (HF) (median left ventricular ejection fraction: 26%) treated with MitraClip as a bridge strategy according to 1 of the following criteria: (1) patients active on HTx list (in list group) (nâ¯=â¯31); (2) patients suitable for HTx but awaiting clinical decision (bridge to decision group) (nâ¯=â¯54); or (3) patients not yet suitable for HTx because of potentially reversible relative contraindications (bridge to candidacy group) (nâ¯=â¯34). RESULTS: Procedural success was achieved in 87.5% of cases, and 30-day survival was 100%. At 1 year, Kaplan-Meier estimates of freedom from the composite primary end-point (death, urgent HTx or left ventricular assist device implantation, first rehospitalization for HF) was 64%. At the time of last available follow-up (median: 532 days), 15% of patients underwent elective transplant, 15.5% remained or could be included in the HTx waiting list, and 23.5% had no more indication to HTx because of clinical improvement. CONCLUSIONS: MitraClip procedure as a bridge strategy to HTx in patients with advanced HF with significant mitral regurgitation was safe, and two thirds of patients remained free from adverse events at 1 year. These findings should be considered exploratory and hypothesis-generating to guide further study for percutaneous intervention in high-risk patients with advanced HF.
Subject(s)
Heart Failure/surgery , Heart Transplantation , Heart Valve Prosthesis Implantation/methods , Mitral Valve Insufficiency/surgery , Mitral Valve/surgery , Registries , Female , Heart Failure/complications , Humans , Male , Middle Aged , Mitral Valve Insufficiency/complications , Prosthesis Design , Risk Factors , Time Factors , Treatment OutcomeABSTRACT
OBJECTIVES: To analyze the effectiveness of the transradial approach in reducing bleeding rates following urgent percutaneous coronary intervention (PCI) in patients with acute coronary syndromes treated with glycoprotein IIb/IIIa inhibitors (GPIs). BACKGROUND: PCI and use of GPIs are recommended in acute coronary syndromes, but are strong predictors of severe hemorrhagic complications, which, in turn, are associated with reduced survival. The transradial approach represents a simple and effective solution to reduce vascular access site bleedings, particularly with GPIs. METHODS: All consecutive patients undergoing urgent transradial PCI under GPI treatment were enrolled in the registry. No patients were excluded. In addition, we performed a case-matched comparison of the transradial versus transfemoral approach using propensity analysis to adjust for known risk factors for bleeding. The primary end point was the rate of bleedings, graded according to the Thrombolysis in Myocardial Infarction (TIMI) classification. RESULTS: Five hundred thirty-one consecutive patients were prospectively enrolled in the registry. TIMI major, minor, and minimal bleedings were 0.2%, 1.7%, and 6.4%, respectively. Transfusion rate was 0.8%. After propensity-matched analysis, the transradial approach was associated with significantly lower rates of all types of bleedings, while the transfemoral approach was the strongest predictor of TIMI major/minor bleedings (odds ratio 6.67; 95% confidence interval 1.72-25; P = 0.006). CONCLUSIONS: The transradial approach dramatically reduces access site bleedings, including TIMI major and minor bleedings, and transfusion rate, while preserving procedural success and clinical outcome. The transradial approach is an attractive solution to reduce bleeding complications in patients treated with GPIs.
Subject(s)
Acute Coronary Syndrome/therapy , Angioplasty, Balloon, Coronary/adverse effects , Femoral Artery , Hemorrhage/prevention & control , Platelet Aggregation Inhibitors/adverse effects , Platelet Glycoprotein GPIIb-IIIa Complex/antagonists & inhibitors , Radial Artery , Acute Coronary Syndrome/blood , Acute Coronary Syndrome/mortality , Aged , Aged, 80 and over , Angioplasty, Balloon, Coronary/methods , Angioplasty, Balloon, Coronary/mortality , Blood Transfusion , Emergency Treatment , Female , Hemorrhage/etiology , Hemorrhage/mortality , Humans , Logistic Models , Male , Middle Aged , Odds Ratio , Prospective Studies , Punctures , Registries , Risk Assessment , Risk Factors , Severity of Illness IndexABSTRACT
BACKGROUND: Large prospective studies on the use of bioresorbable vascular scaffolds (BVS) for diffuse coronary artery disease are lacking. IT DISAPPEARS is a large multicentre prospective registry investigating the short and long-term outcomes of everolimus-eluting BVS in patients with long coronary lesions and/or multivessel coronary artery disease (ClinicalTrials.gov: NCT02004730). We hereby report the 2-year outcomes of the registry. METHODS: We enrolled 1002 patients with complex lesions undergoing implantation of 2040 BVS with a prespecified technique including predilation, correct sizing, and postdilation with non-compliant balloons. The primary endpoint was the rate of device-oriented composite endpoint (DOCE), consisting of cardiac death, target vessel-related myocardial infarction (MI), and ischaemia-driven target lesion revascularization (TLR). Secondary endpoints included: 1) patient-oriented composite endpoint (POCE), consisting of all-cause mortality, all infarctions and all revascularisations; 2) definite/probable scaffold thrombosis. RESULTS: Clinical presentation was an acute coronary syndrome in 59.8% of patients. Total BVS length implanted was 47⯱â¯22â¯mm. Postdilation of all scaffolds per patient was performed in 96.8%, while optimal implantation as per study guidelines was applied in 71.4%. Through 2-year follow-up, DOCE occurred in 9.5% of patients (cardiac death 0.6%, target vessel-related MI 5.3%, TLR 6.6%). The rate of POCE was 16.6% and of scaffold thrombosis 1.1%. Female gender, total length of coronary lesions, treatment of bifurcation lesions and use of 2.5â¯mm scaffolds were independent predictors of DOCE. CONCLUSIONS: The 2-year results of IT-DISAPPEARS show that BVS may yield acceptable clinical outcomes in patients with complex coronary lesions when the implantation technique is appropriate.
Subject(s)
Absorbable Implants/trends , Acute Coronary Syndrome/epidemiology , Acute Coronary Syndrome/therapy , Drug-Eluting Stents/trends , Everolimus/administration & dosage , Registries , Aged , Female , Follow-Up Studies , Humans , Italy/epidemiology , Male , Middle Aged , Prospective Studies , Time Factors , Tissue Scaffolds/trends , Treatment OutcomeABSTRACT
INTRODUCTION: Acute coronary syndromes (ACS) have been classified according to the finding of ST-segment elevation on the presenting electrocardiogram, with different treatment strategies and practice guidelines. However, a comparative description of the clinical characteristics and outcomes of acute coronary syndrome elderly patients undergoing percutaneous coronary intervention during index admission has not been published so far. METHODS: Retrospective cohort study of patients enrolled in the Elderly ACS-2 multicenter randomized trial. Main outcome measures were crude cumulative incidence and cause-specific hazard ratio (cHR) of cardiovascular death, noncardiovascular death, reinfarction, and stroke. RESULTS: Of 1443 ACS patients aged >75 years (median age 80 years, interquartile range 77-84), 41% were classified as ST-elevation myocardial infarction (STEMI), and 59% had non-ST-elevation ACS (NSTEACS) (48% NSTEMI and 11% unstable angina). As compared with those with NSTEACS, STEMI patients had more favorable baseline risk factors, fewer prior cardiovascular events, and less severe coronary disease, but lower ejection fraction (45% vs 50%, P < .001). At a median follow-up of 12 months, 51 (8.6%) STEMI patients had died, vs 39 (4.6%) NSTEACS patients. After adjusting for sex, age, and previous myocardial infarction, the hazard among the STEMI group was significantly higher for cardiovascular death (cHR 1.85; 95% confidence interval [CI], 1.02-3.36), noncardiovascular death (cHR 2.10; 95% CI, 1.01-4.38), and stroke (cHR 4.8; 95% CI, 1.7-13.7). CONCLUSIONS: Despite more favorable baseline characteristics, elderly STEMI patients have worse survival and a higher risk of stroke compared with NSTEACS patients after percutaneous coronary intervention.
Subject(s)
Acute Coronary Syndrome/therapy , Electrocardiography , Myocardial Infarction/therapy , Percutaneous Coronary Intervention/adverse effects , Aged , Aged, 80 and over , Cohort Studies , Female , Humans , Male , Retrospective Studies , Stroke/etiology , Treatment OutcomeSubject(s)
Aortic Valve Stenosis , Atrial Fibrillation , Heart Valve Prosthesis Implantation , Transcatheter Aortic Valve Replacement , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/surgery , Atrial Fibrillation/diagnosis , Atrial Fibrillation/etiology , Atrial Fibrillation/therapy , Heart Valve Prosthesis Implantation/adverse effects , Humans , Transcatheter Aortic Valve Replacement/adverse effects , Treatment OutcomeABSTRACT
BACKGROUND: Despite promising results following transcatheter aortic valve implantation (TAVI), several relevant challenges still remain. To overcome these issues, new generation devices have been developed. The purpose of the present study was to determine whether TAVI with the new self-expanding repositionable Evolut R offers potential benefits compared to the preceding CoreValve, using propensity matching. METHODS: Between June 2007 and November 2015, 2148 consecutive patients undergoing TAVI either CoreValve (n=1846) or Evolut R (n=302) were prospectively included in the Italian TAVI ClinicalService® project. For the purpose of our analysis 211 patients treated with the Evolut R were matched to 211 patients treated with the CoreValve. An independent core laboratory reviewed all angiographic procedural data and an independent clinical events committee adjudicated all events. RESULTS: Patients treated with Evolut R experienced higher 1-year overall survival (log rank test p=0.045) and a significantly lower incidence of major vascular access complications, bleeding events and acute kidney injury compared to patients treated with the CoreValve. Recapture manoeuvres to optimize valve deployment were performed 44 times, allowing a less implantation depth for the Evolut R. As a consequence, the rate of more than mild paravalvular leak and new permanent pacemaker was lower in patients receiving the Evolut R. CONCLUSION: In this matched comparison of high surgical risk patients undergoing TAVI, the use of Evolut R was associated with a significant survival benefit at 1year compared with the CoreValve. This was driven by lower incidence of periprocedural complications and higher rates of correct anatomic positioning.
Subject(s)
Aortic Valve Stenosis/surgery , Heart Valve Prosthesis/standards , Prosthesis Design/standards , Transcatheter Aortic Valve Replacement/instrumentation , Transcatheter Aortic Valve Replacement/standards , Aged , Aged, 80 and over , Aortic Valve Stenosis/mortality , Female , Follow-Up Studies , Humans , Male , Postoperative Complications/etiology , Postoperative Complications/mortality , Postoperative Complications/prevention & control , Prospective Studies , Retrospective Studies , Survival Rate/trends , Transcatheter Aortic Valve Replacement/adverse effectsABSTRACT
OBJECTIVES: The aim of this study was to evaluate the use of transcatheter heart valves (THV) for the treatment of noncalcific pure native aortic valve regurgitation (NAVR) and failing bioprosthetic surgical heart valves (SHVs) with pure severe aortic regurgitation (AR). BACKGROUND: Limited data are available about the "off-label" use of transcatheter aortic valve replacement (TAVR) to treat pure severe AR. METHODS: The study population consisted of patients with pure severe AR treated by TAVR at 18 different centers. Study endpoints were device success, early safety, and clinical efficacy at 30 days, as defined by Valve Academic Research Consortium 2 criteria. RESULTS: A total of 146 patients were included, 78 patients in the NAVR group and 68 patients in the failing SHV group. In the NAVR group, device success, early safety, and clinical efficacy were 72%, 66%, and 61%, respectively. Device success and clinical efficacy were significantly better with newer generation THVs compared with old-generation THVs (85% vs. 54% and 75% vs. 46%, respectively, p < 0.05); this was mainly due to less second THV implantations and a lower rate of moderate to severe paravalvular regurgitation (10% vs. 24% and 3% vs. 27%, respectively). Independent predictors of 30-day mortality were body mass index <20 kg/m2, STS surgical risk score >8%, major vascular or access complication, and moderate to severe AR. In the failing SHV group, device success, early safety, and clinical efficacy were 71%, 90%, and 77%, respectively. CONCLUSIONS: TAVR for pure NAVR remains a challenging condition, with old-generation THVs being associated with THV embolization and migration and significant paravalvular regurgitation. Newer generation THVs show more promising outcomes. For those patients with severe AR due to failing SHVs, TAVR is a valuable therapeutic option.
Subject(s)
Aortic Valve Insufficiency/surgery , Aortic Valve/surgery , Bioprosthesis , Heart Valve Prosthesis Implantation/instrumentation , Heart Valve Prosthesis , Prosthesis Failure , Transcatheter Aortic Valve Replacement/instrumentation , Aged , Aged, 80 and over , Aortic Valve/diagnostic imaging , Aortic Valve/physiopathology , Aortic Valve Insufficiency/diagnostic imaging , Aortic Valve Insufficiency/mortality , Aortic Valve Insufficiency/physiopathology , Coronary Angiography , Echocardiography , Female , Heart Valve Prosthesis Implantation/adverse effects , Heart Valve Prosthesis Implantation/mortality , Humans , Male , Middle Aged , Registries , Risk Factors , Time Factors , Transcatheter Aortic Valve Replacement/adverse effects , Transcatheter Aortic Valve Replacement/mortality , Treatment OutcomeABSTRACT
AIMS: Transcatheter aortic valve implantation (TAVI) represents a valid therapeutic alternative for patients with severe aortic stenosis at high surgical risk. However, there is no general consensus regarding the role of anaesthesia in TAVI management. The goal of this clinical project was to assess the safety and non-inferiority of local anaesthesia (LA) versus general anaesthesia (GA) in a large cohort of patients undergoing TAVI. METHODS AND RESULTS: All 1,316 consecutive patients who underwent TAVI at seven high-volume Italian centres were enrolled. The anaesthetic regimen consisted of GA in 355 (26.9%) patients or LA in 961 (73.0%) patients. Baseline demographics were similar between the two groups except for a higher median logistic EuroSCORE (p=0.004) and peripheral artery disease (p<0.001) in the GA group. The two groups showed similar device success with no significant difference in terms of mortality, stroke and myocardial infarction. The overall procedural time was longer with the use of GA (p<0.001). The LA group showed a lower incidence of major access-site complications (p=0.01) and major (p=0.03) and life-threatening bleedings (p<0.001) with a lower occurrence of acute kidney injury stage 3 (p=0.002). Consistently, we observed a significantly shorter length of hospital stay in LA patients (8 days [7-13] vs. 7 days [6-10], GA vs. LA; p<0.001). As the GA patients were found to be at higher risk due to a higher prevalence of peripheral artery disease we carried out a propensity matching to obtain two comparable groups. This sub-analysis confirmed the same results previously observed in the overall population. As expected, in the GA group we observed longer procedural time, higher use of a surgical vascular access, higher incidence of acute kidney injury stage 3 and higher rate of bleeding and major vascular access-site complications. CONCLUSIONS: Our study indicates that, in experienced centres which have gone beyond their initial learning curve with TAVI, the use of local anaesthesia in a selected patient population can be associated with good clinical outcomes. Nevertheless, as severe procedural complications are possible, an anaesthesiologist should always be present as part of the team.
Subject(s)
Anesthetics , Aortic Valve Stenosis/surgery , Heart Valve Prosthesis Implantation , Transcatheter Aortic Valve Replacement , Aged , Aged, 80 and over , Anesthetics/adverse effects , Female , Heart Valve Prosthesis Implantation/adverse effects , Heart Valve Prosthesis Implantation/methods , Humans , Incidence , Italy , Length of Stay/statistics & numerical data , Male , Postoperative Complications/epidemiology , Registries , Risk Factors , Transcatheter Aortic Valve Replacement/adverse effects , Transcatheter Aortic Valve Replacement/methods , Treatment OutcomeABSTRACT
BACKGROUND: Epidemiological studies have shown a higher risk of cardiovascular mortality associated with early menopause, but the relation between menopausal age and extent of coronary artery disease after menopause is unknown. We assessed the relation between menopausal age and extent of coronary disease in postmenopausal women with an acute coronary syndrome. METHODS: A prospective study was conducted in patients ≥55 years old undergoing coronary angiography for an acute coronary syndrome. Enrollment was stratified by sex (women/men ratio 2:1) and age (55-64, 65-74, 75-85, and >85 years). Women were administered menopause questionnaires during admission. An independent core lab quantified coronary artery disease extent using the Gensini Score, which classifies both significant (>50%) and nonsignificant lesions. Linear correlation was used to appraise the association between the Gensini score and menopausal age. RESULTS: We enrolled 675 patients, 249 men and 426 women (mean age 74 years). The mean Gensini score was 60 ± 36 in men vs 50 ± 32 in women (P <.001), being higher among men at any age. The median menopausal age of women was 50 years. Risk factors and age at first acute coronary syndrome were identical among women below and above the median menopausal age. The Gensini score in women showed a weak association with age (R = 0.127; P = .0129), but not with menopausal age (R = 0.063; P = .228). At multivariable analysis, ejection fraction, female sex, and ST elevation myocardial infarction were independent predictors of the Gensini score in the overall population. CONCLUSIONS: Menopausal age was not associated with the extent of coronary artery disease. Age at first acute coronary syndrome presentation, risk factors, and prior cardiovascular events were not affected by menopausal age. (The LADIES ACS study: NCT01997307).
Subject(s)
Acute Coronary Syndrome/diagnostic imaging , Coronary Artery Disease/diagnostic imaging , Menopause , Age Factors , Aged , Aged, 80 and over , Coronary Angiography , Female , Humans , Linear Models , Middle Aged , Postmenopause , Prospective Studies , Severity of Illness IndexABSTRACT
OBJECTIVES: This study sought to investigate sex-related differences in treatment and outcomes in elderly patients with non-ST-segment elevation acute coronary syndromes (NSTEACS). BACKGROUND: Female sex and older age are usually associated with worse outcome in NSTEACS. The Italian Elderly ACS study enrolled NSTEACS patients aged 75 years of age and older in a randomized trial comparing an early aggressive with an initially conservative strategy and in a registry of patients with ≥1 exclusion criteria of the trial. METHODS: We compared sexes in the pooled populations of the trial and registry. RESULTS: A total of 645 patients (313 from the trial and 332 from the registry), including 301 women (47%), were enrolled. Women were slightly older than men (82.1 ± 5.0 years vs. 81.2 ± 4.5 years; p = 0.02), had lower hemoglobin levels (12.5 ± 1.6 g/dl vs. 13.3 ± 1.9 g/dl; p < 0.001), and underwent fewer coronary revascularizations during the index admission (37.2% vs. 45.0%; p = 0.04). In-hospital adverse event rates were similar in both sexes; severe bleeding was uncommon (0.3% vs. 0%). The 1-year primary endpoint (composite of death, nonfatal myocardial infarction, disabling stroke, cardiac rehospitalization, and severe bleeding) occurred less often in women (27.6% vs. 38.7%; p < 0.01). Women not undergoing revascularization showed a 3-fold higher mortality, both in-hospital (8.5% vs. 2.7%; p = 0.05) and at 1 year (21.6% vs. 8.1%; p = 0.002). CONCLUSIONS: Elderly women had a similar in-hospital outcome and better 1-year outcome compared with men. Coronary revascularization in women was associated with lower 1-year mortality, without an increase in severe bleeding. Elderly women with NSTEACS should always be considered for early revascularization.
Subject(s)
Acute Coronary Syndrome/therapy , Health Status Disparities , Healthcare Disparities , Myocardial Revascularization , Acute Coronary Syndrome/diagnosis , Acute Coronary Syndrome/mortality , Age Factors , Aged , Aged, 80 and over , Female , Hemorrhage/etiology , Hemorrhage/mortality , Hospital Mortality , Humans , Italy , Male , Myocardial Revascularization/adverse effects , Myocardial Revascularization/mortality , Patient Selection , Registries , Risk Assessment , Risk Factors , Sex Factors , Time Factors , Treatment OutcomeABSTRACT
BACKGROUND: Carotid artery stenting (CAS) is a worldwide diffuse intervention, but may be associated with distal plaque component embolization, and sometimes major and minor stroke. Statin use has been demonstrated to reduce atherosclerotic plaque burden, but its effect in reducing distal embolization during carotid stenting has not yet been well validated. AIMS: With the Rosuvastatin Pretreatment to Reduce Embolization during Carotid Artery Stenting trial, we aim to discover if a pretreatement with high doses of rosuvastatin in dyslipidemic patients is able to reduce periprocedural cerebral ischemic complications following carotid stenting. METHODS: This is a phase III prospective, randomized controlled trial. All consecutive patients with asymptomatic carotid stenosis at least 80% will be randomized to a 6-week rosuvastatin treatment followed by carotid stenting, and to direct carotid stenting. Carotid stenting will be performed following common practice with distal or proximal embolic protection. The primary efficacy end point of the trial will be the prevalence of 'relevant' embolization during CAS, as a surrogate end point for cerebral ischemic complications. Other laboratory and clinical data will be registered and patients will be followed up to 1 year. In order to obtain the expected superiority of statin pretreatment on primary end point, a population of 130 patients will be enrolled into the study. CONCLUSION: In conclusion, with the Rosuvastatin Pretreatment to Reduce Embolization during Carotid Artery Stenting trial, we want to evaluate whether a high dose of rosuvastatin for 6 weeks before CAS in asymptomatic patients with severe carotid stenosis is able to reduce the rate of plaque embolization during the procedure, thus suggesting a possible reduction in cerebral ischemic complications.