FemoSeal Evaluation Registry (FER). Prospective study of femoral arterial closure with a mechanical system on 100 patients who underwent angioplasty procedures

Background

The objective of this study is to evaluate the effectiveness and the safety of the FemoSeal mechanical closure system in order to obtain hemostasis of the puncture site following angioplasty procedures performed through femoral arterial approach.

Method

A single-centre prospective registry was conducted from November 2010 to April 2011, comparing the results of manual compression (n = 111 patients), hemostatic bandages compression (n = 43 patients) and FemoSeal mechanical closure (n = 100 patients). The end points evaluated were the following: successful hemostasis, major and minor complications right after the procedures and major and minor complications at 1 month follow-up. The patients’ feedback about their comfort was also collected right after the procedure and after one month.

Results

Successful hemostasis with FemoSeal was obtained in 93% of the patients (n = 93). Seven patients required additional slight manual compressions or compression bandages. The use of FemoSeal was not associated with any major complications, significantly reducing (P < 0.05) the number of complications compared to other compression techniques over the studied period. Only one minor complication was observed with FemoSeal (a 1.5-cm-hematoma, which reabsorbed spontaneously without any issue).

Conclusion

In our experience, the use of FemoSeal is effective in achieving hemostasis performed through femoral arterial approach up to 7F and is associated with a very low rate of complications.     

El uso del acceso radial en la angioplastia primaria: resultados en 1.029 pacientes consecutivos y análisis en subgrupos desfavorables

Introduction and objectives

The transradial approach is associated with a reduction in vascular access-related complications after primary percutaneous coronary interventions. The purpose of this study was to examine the feasibility of the routine use of transradial access in primary angioplasty and to evaluate how it affects subgroups with less favorable characteristics.

Methods

We analyzed 1029 consecutive patients with an ST-segment elevation acute coronary syndrome treated with primary angioplasty.

Results

Transradial access was the primary approach in 93.1% of the patients. The success rate of primary angioplasty was 95.9%, and 87.6% of the patients were event-free 30 days after the procedure. Crossover was required in 3.0% of the patients with primary transradial access, and this rate remained stable over the years. Predictors of the need for crossover were age older than 75 years (odds ratio=2.50, 95% confidence interval, 1.09–5.71; P=.03) and a history of ischemic heart disease (odds ratio=2.65; 95% confidence interval, 1.12–6.24; P=.02). Primary transfemoral access use was higher in women older than 75 years. Use of the transradial approach in this subgroup did not affect reperfusion time or the success of angioplasty, although there was a greater need for crossover (10.9% vs 2.6%; P=.006). Among patients in cardiogenic shock, the transradial approach was used in 51.5%; reperfusion times and angioplasty success rates were similar to those obtained with transfemoral access, but there was a greater need for crossover.

Conclusions

Transradial access can be used safely and effectively in most primary angioplasty procedures. In older women and in patients in cardiogenic shock, there is a higher crossover requirement, with no detriment to reperfusion time.Full English text available from:www.revespcardiol.org/en     

Complications vasculaires de l’abord artériel fémoral : impact du système de fermeture percutanée Perclose

Introduction

Vascular complications at the femoral access site is an important factor of morbidity. The aims of this study were to evaluate the efficacy and safety of the percutaneous closure device (Perclose) during interventional cardiology procedures.

Patients and methods

All patients with percutaneous closure of the femoral access site by the Perclose system in 2010 were included. We evaluated the indications of the procedures, the success rate of implantation and the bleeding complications according to antithrombotic therapy used.

Results

Three hundred and seventy five patients underwent a percutaneous closure by the Perclose system. Acute coronary syndromes with or without elevation of ST segment were the main indications of procedures (74.9%). The success rate of percutaneous closure of the femoral access site was 97.3%. The rate of minor, moderate, and severe bleeding of the entire cohort according to the GUSTO classification was respectively 4.2%, 0.5% and 1%. Bleeding complications were similar in both groups of patients (2.1% vs 7% P = 0.122). In case of unsuccessful deployment of femoral closure devices, the risk of bleeding complications range from 4.3% to 60% (P = 0.0000036).

Conclusion

The use of the Perclose system is associated with a low rate of severe bleeding at the femoral access site. However, the failures of percutaneous closure increase the risk of bleeding complications.     

Eficacia de los scores de riesgo hemorrágico en el paciente anciano con síndrome coronario agudo

Introduction and objectives

The incidence of acute coronary syndromes is high in the elderly population. Bleeding is associated with a poorer prognosis in this clinical setting. The available bleeding risk scores have not been validated specifically in the elderly. Our aim was to assess predictive ability of the most important bleeding risk scores in patients with acute coronary syndrome aged ≥ 75 years.

Methods

We prospectively included consecutive acute coronary syndromes patients. Baseline characteristics, laboratory findings, and hemodynamic data were collected. In-hospital bleeding was defined according to CRUSADE, Mehran, ACTION, and BARC definitions. CRUSADE, Mehran, and ACTION bleeding risk scores were calculated for each patient. The ability of these scores to predict major bleeding was assessed by binary logistic regression, receiver operating characteristic curves, and area under the curves.

Results

We included 2036 patients, with mean age of 62.1 years; 369 patients (18.1%) were ≥ 75 years. Older patients had higher bleeding risk (CRUSADE, 42 vs 22; Mehran, 25 vs 15; ACTION, 36 vs 28; P<.001) and a slightly higher incidence of major bleeding events (CRUSADE bleeding, 5.1% vs 3.8%; P=.250). The predictive ability of these 3 scores was lower in the elderly (area under the curve, CRUSADE: 0.63 in older patients, 0.81 in young patients; P = .027; Mehran: 0.67 in older patients, 0.73 in younger patients; P = .340; ACTION: 0.58 in older patients, 0.75 in younger patients; P = .041).

Conclusions

Current bleeding risk scores showed poorer predictive performance in elderly patients with acute coronary syndromes than in younger patients.Full English text available from:www.revespcardiol.org/en     

Percutaneous Implantation of the CoreValve Self-expanding Valve Prosthesis in Patients With Severe Aortic Stenosis and Porcelain Aorta: Medium-term Follow-up

Introduction and objectives

There is little information on the use of transcatheter aortic valve implantation in patients with severe aortic stenosis and porcelain aorta. The primary aim of this study was to analyze death from any cause after CoreValve^® implantation in patients with severe aortic stenosis, with and without porcelain aorta.

Methods

In this multicenter, observational prospective study, carried out in 3 hospitals, percutaneous aortic valves were implanted in 449 patients with severely calcified aortic stenosis. Of these, 36 (8%) met the criteria for porcelain aorta. The primary end-point was death from any cause at 2 years.

Results

Patients with porcelain aorta more frequently had extracardiac vascular disease (11 [30.6%] vs 49 [11.9%]; P=.002), prior coronary revascularization (15 [41.7%] vs 98 [23.7%]; P=.017), and dyslipidemia (26 [72.2%] vs 186 [45%]; P=.02). In these patients, there was greater use of general anesthesia (15 [41.7%] vs 111 [16.9%]; P=.058) and axillary access (9 [25%] vs 34 [8.2%]; P=.004). The success rate of the procedure (94.4 vs 97.3%; P=.28) and the incidence of complications (7 [19.4%] vs 48 [11.6%]; P=.20) were similar in both groups. There were no statistically significant differences in the primary end point at 24 months of follow-up (8 [22.2%] vs 66 [16%]; P=.33). The only predictive variable for the primary end point was the presence of complications during implantation (hazard ratio=2.6; 95% confidence interval, 1.5-4.5; P=.001).

Conclusions

In patients with aortic stenosis and porcelain aorta unsuitable for surgery, percutaneous implantation of the CoreValve^® self-expanding valve prosthesis is safe and feasible.     

Triple antiplatelet therapy does not increase femoral access bleeding with vascular closure devices

Background

The use of arteriotomy closure devices (CDs) to achieve hemostasis after femoral artery access in percutaneous coronary intervention is steadily increasing. However, the safety information with these devices in the era of triple antiplatelet therapy is limited.

Methods

We reviewed prospectively collected data from the Do Tirofiban and ReoPro Give Similar Efficacy Outcomes Trial (TARGET), where all patients received aspirin, clopidogrel, and glycoprotein IIb/IIIa inhibitor therapy. At the treating physician's discretion, manual compression (MC) or a vascular hemostasis device was selected following femoral angiography. Patients receiving MC were to have sheaths removed 2 to 6 hours postprocedure when the activated clotting time was ≤ 175 seconds.

Results

Of 4809 patients, 4736 had femoral access, and 985 of these had a CD (Perclose 47%, Angio-Seal 43%, VasoSeal 5%, and other 5%). The MC and CD groups were similar regarding most demographic characteristics, including age, systolic blood pressure, and weight, but those with MC were more often female, diabetic, and had history of peripheral vascular disease. Patients with a CD had a lower ischemic event rate suggesting they were a lower risk cohort overall. There were no differences in major bleeding at the access site (0.4% vs 0.5%, P = .588), minor bleeding at the access site (1.9% vs. 3.1%, P = .142) or transfusions (0.8% vs 1.0%, P = .513) between the MC and CD groups, respectively.

Conclusions

In contemporary percutaneous coronary intervention practice, with appropriate patient selection, a CD can be safely utilized despite aggressive polypharmacy for procedural anticoagulation.     

Ancho de distribución eritrocitaria y predicción adicional del riesgo de hemorragia mayor en el síndrome coronario agudo sin elevación del ST

Introduction and objectives

Red cell distribution width has been linked to an increased risk for in-hospital bleeding in patients with non–ST-segment elevation acute coronary syndrome. However, its usefulness for predicting bleeding complications beyond the hospitalization period remains unknown. Our aim was to evaluate the complementary value of red cell distribution width and the CRUSADE scale to predict long-term bleeding risk in these patients.

Methods

Red cell distribution width was measured at admission in 293 patients with non–ST-segment elevation acute coronary syndrome. All patients were clinically followed up and major bleeding events were recorded (defined according to Bleeding Academic Research Consortium Definition criteria).

Results

During a follow-up of 782 days [interquartile range, 510-1112 days], events occurred in 30 (10.2%) patients. Quartile analyses showed an abrupt increase in major bleedings at the fourth red cell distribution width quartile (> 14.9%; P = .001). After multivariate adjustment, red cell distribution width > 14.9% was associated with higher risk of events (hazard ratio = 2.67; 95% confidence interval, 1.17-6.10; P = .02). Patients with values ≤ 14.9% and a CRUSADE score ≤ 40 had the lowest events rate, while patients with values > 14.9% and a CRUSADE score > 40 points (high and very high risk) had the highest rate of bleeding (log rank test, P < .001). Further, the addition of red cell distribution width to the CRUSADE score for the prediction of major bleeding had a significant integrated discrimination improvement of 5.2% (P < .001) and a net reclassification improvement of 10% (P = .001).

Conclusions

In non–ST-segment elevation acute coronary syndrome patients, elevated red cell distribution width is predictive of increased major bleeding risk and provides additional information to the CRUSADE scale.Full English text available from: www.revespcardiol.org/en     

Importancia de la carga vascular previa en la mortalidad intrahospitalaria y a largo plazo de pacientes con infarto de miocardio y segmento ST elevado

Introduction and objectives

Patients with a current acute coronary syndrome and previous ischemic heart disease, peripheral arterial disease, or cerebrovascular disease are reported to have a poorer outcome than those without these previous conditions. It is uncertain whether this association with outcome is observed at long-term follow-up.

Methods

Prospective observational study, including 4247 patients with ST-segment elevation myocardial infarction. Detailed clinical data and information on previous ischemic heart disease, peripheral arterial disease, and cerebrovascular disease («vascular burden») were recorded. Multivariate models were performed for in-hospital and long-term (median, 7.2 years) all-cause mortality.

Results

One vascular territory was affected in 1131 (26.6%) patients and ≥ 2 territories in 221 (5.2%). The total in-hospital mortality rate was 12.3% and the long-term incidence density was 3.5 deaths per 100 patient-years. A background of previous ischemic heart disease (odds ratio = 0.83; P = .35), peripheral arterial disease (odds ratio = 1.30; P=.34), or cerebrovascular disease (stroke) (odds ratio = 1.15; P = .59) was not independently predictive of in-hospital death. In an adjusted model, previous cerebrovascular disease and previous peripheral arterial disease were both predictors of mortality at long-term follow-up (hazard ratio = 1.57; P < .001; and hazard ratio = 1.34; P = .001; respectively). Patients with ≥ 2 diseased vascular territories showed higher long-term mortality (hazard ratio = 2.35; P < .001), but not higher in-hospital mortality (odds ratio = 1.07; P = .844).

Conclusions

In patients with a diagnosis of ST-segment elevation acute myocardial infarction, the previous vascular burden determines greater long-term mortality. Considered individually, previous cerebrovascular disease and peripheral arterial disease were predictors of mortality at long-term after hospital discharge.Full English text available from: www.revespcardiol.org/en     

Efecto del tratamiento optimizado con insulina en la reactividad plaquetaria tras el alta de pacientes hiperglucémicos con síndrome coronario agudo

Introduction and objectives

Intensive glucose control with insulin in patients with an acute coronary syndrome reduces platelet reactivity during hospitalization, compared to conventional control. However, the effect of strict, long-term glucose control on platelet reactivity in these patients remains uncertain.

Methods

This is a prospective, randomized trial evaluating the effects of optimized glucose control (target glucose, 80-120 mg/dL) with insulin, compared with conventional control (target glucose, <180 mg/dL), on platelet reactivity after hospital discharge in patients with an acute coronary syndrome and hyperglycemia. The primary endpoint was assessment of platelet aggregation after stimulation with adenosine diphosphate 20 μM at 12-month follow-up.

Results

One hundred four patients were randomized to optimized management (n=53) or conventional management (n=51). There were no differences between groups in baseline characteristics or platelet function. After 12 months of follow-up, blood glucose levels were significantly lower in the optimized treatment group (104 vs 119 mg/dL; P<.001). However, platelet aggregation following adenosine diphosphate 20 μM stimulation showed no differences between the groups (54.2% [14.3%] vs 55.1% [18.3%] respectively; P=.81). There were no significant differences for other platelet function tests.

Conclusions

Long-term optimized glucose control with insulin in patients with an acute coronary syndrome did not result in a reduction in platelet reactivity compared to conventional control.Full English text available from:www.revespcardiol.org/en     

Actitud y eficacia de los cardiólogos frente al tabaquismo de los pacientes tras un síndrome coronario agudo

Introduction and objectives

Smoking is one of the most prevalent risk factors in acute coronary syndrome patients. The aim of this study was to assess the attitudes of cardiologists to the smoking habits of these patients

Methods

A prospective multicenter registry of acute coronary syndrome patients. The primary endpoint was defined as smoking abstinence and the secondary endpoint as the incidence of all-cause mortality or nonfatal myocardial infarction.

Results

The study population included 715 patients; 365 were current smokers. During follow-up (median, 375,0 days [interquartile range, 359.3-406.0 days]), 110 patients (30.6%) received smoking cessation support (19.7% at hospital discharge and 37.6% at month 3), specialized units and varenicline being the strategies most frequently used. No clinical differences were observed between patients who received smoking cessation support and those who did not, except for a higher prevalence of previous coronary heart disease in those who received support. In the multivariate analysis, the only variable independently associated with receiving smoking cessation support was previous coronary heart disease (odds ratio =3.16; 95% confidence interval, 1.64-6.11; P<.01). The abstinence rate was 72.3% at month 3 and 67.9% at 1 year; no differences were observed between the patients who received smoking cessation support and those who did not. During follow-up, a nonsignificant trend toward a lower incidence of the secondary endpoint was observed among the patients who were smokers at the time of acute coronary syndrome and who achieved abstinence (P=.07).

Conclusions

Use of smoking cessation support strategies is limited in acute coronary syndrome patients and is more widespread among those with previous coronary heart disease.Full English text available from:www.revespcardiol.org     

Implante percutáneo de la válvula autoexpandible CoreValve en pacientes con estenosis aórtica grave y aorta de porcelana: seguimiento a medio plazo

Introduction and objectives

There is little information on the use of transcatheter aortic valve implantation in patients with severe aortic stenosis and porcelain aorta. The primary aim of this study was to analyze death from any cause after CoreValve^® implantation in patients with severe aortic stenosis, with and without porcelain aorta.

Methods

In this multicenter, observational prospective study, carried out in 3 hospitals, percutaneous aortic valves were implanted in 449 patients with severely calcified aortic stenosis. Of these, 36 (8%) met the criteria for porcelain aorta. The primary end-point was death from any cause at 2 years.

Results

Patients with porcelain aorta more frequently had extracardiac vascular disease (11 [30.6%] vs 49 [11.9%]; P=.002), prior coronary revascularization (15 [41.7%] vs 98 [23.7%]; P=.017), and dyslipidemia (26 [72.2%] vs 186 [45%]; P=.02). In these patients, there was greater use of general anesthesia (15 [41.7%] vs 111 [16.9%]; P=.058) and axillary access (9 [25%] vs 34 [8.2%]; P=.004). The success rate of the procedure (94.4 vs 97.3%; P=.28) and the incidence of complications (7 [19.4%] vs 48 [11.6%]; P=.20) were similar in both groups. There were no statistically significant differences in the primary end point at 24 months of follow-up (8 [22.2%] vs 66 [16%]; P=.33). The only predictive variable for the primary end point was the presence of complications during implantation (hazard ratio=2.6; 95% confidence interval, 1.5-4.5; P=.001).

Conclusions

In patients with aortic stenosis and porcelain aorta unsuitable for surgery, percutaneous implantation of the CoreValve^® self-expanding valve prosthesis is safe and feasible.Full English text available from: www.revespcardiol.org/en     

Aortic coarctation and the retinal microvasculature

Background

Aortic coarctation has been associated with generalized vascular disease, yet little is known about retinal vascular patterns and their changes over time.

Objectives

The aim of this study is to characterize the nature and extent of retinal vascular disease in adults with aortic coarctation, and explore age-related effects and associations with cardiovascular outcomes.

Methods

A prospective cross-sectional seroepidemiological study was conducted on 60 consecutive adults with repaired aortic coarctation, age 42.4 ± 14.1 years, 61.7% male. In addition to detailed questionnaires, imaging studies, and laboratory testing, high-quality retinal images were acquired by 45° nonmydriatic digital funduscopy.

Results

No patient had evidence of hypertensive retinopathy. A distinctive vascular pattern characterized by bilaterally symmetric tortuosity of retinal arteries and veins was observed. Arterial tortuosity was abnormal in 98.3% of patients and decreased with age (P = 0.0005). In patients ≥ 45 years, a 1-point increase in the arterial tortuosity score was associated with a 1.5-fold higher risk of cardiovascular complications (i.e., acute coronary syndrome, stroke, cerebral aneurysm, aortic dissection/rupture) [odds ratio 1.50, 95% CI (1.01, 2.24), P = 0.0496]. Abnormal venous tortuosity was present in 75.0% of patients and non-significantly correlated with higher levels of serum inflammatory markers (C-reactive protein, fibrinogen, interleukin-6, and tumor necrosis factor-alpha). A higher venous tortuosity score was likewise associated with an increased risk of cardiovascular complications [odds ratio 1.86, 95% CI (1.03, 3.35), P = 0.0392].

Conclusions

Adults with repaired aortic coarctation exhibit a unique retinal vascular pattern characterized by excessive arterial and venous tortuosity that regresses with age. Greater tortuosity is associated with adverse cardiovascular outcomes in patients ≥ 45 years.     

Primary angioplasty in Northern Galicia: care changes and results following implementation of the PROGALIAM protocol

Introduction and objectives

To analyze changes in healthcare delivery and results for primary angioplasty at Centro Hospitalario Universitario A Coruña following implementation of the PROGALIAM protocol.

Methods

Observational registry of 1434 patients referred for primary angioplasty between 2003 and 2007. Results under PROGALIAM (May 2005 – December 2007; n=963) were compared with those from the preceding period (January 2003 – April 2005; n=388).

Results

After implementing PROGALIAM, there were increases in the number of primary angioplasty procedures (preceding period, 14.4 cases/month; PROGALIAM, 32.2 cases/month), mean patient age (preceding period, 61.3 (11.9) years; PROGALIAM, 64.2 (11.7) years; P<.001), and the percentage of patients referred from peripheral hospitals and treated after normal working hours. Overall median first medical contact-to-balloon time increased (previous period, 106 min; PROGALIAM, 113 min; P=.02), but decreased significantly among patients referred from noninterventional centers (previous period, 171 min; PROGALIAM, 146 min; P<.001). Percentage of cases with an first medical contact-to-balloon time <120 min remained unchanged among interventional-center patients (preceding period, 69%; PROGALIAM, 71%; P=.56) and increased among patients at noninterventional centers, although it remained low in this subgroup (preceding period, 17%; PROGALIAM, 30%; P=.04). Thirty-day mortality (preceding period, 5.2%; PROGALIAM, 6.2%; P=.85) and 1-year mortality (preceding period, 9.5%; PROGALIAM, 10.2%; P=.96) remained unchanged.

Conclusions

Implementation of PROGALIAM allowed us to increase the percentage of patients receiving primary angioplasty without jeopardizing the clinical results of this treatment.Full English text available from:www.revespcardiol.org     

Supervivencia de pacientes ambulatorios con insuficiencia cardiaca crónica del área mediterránea. Un estudio de base poblacional

Introduction and objectives

Scarce research has been performed in ambulatory patients with chronic heart failure in the Mediterranean area. Our aim was to describe survival trends in our target population and the impact of prognostic factors.

Methods

We carried out a population-based retrospective cohort study in Catalonia (north-east Spain) of 5659 ambulatory patients (60% women; mean age 77 [10] years) with incident chronic heart failure. Eligible patients were selected from the electronic patient records of primary care practices from 2005 and were followed-up until 2007.

Results

During the follow-up period deaths occurred in 950 patients (16.8%). Survival after the onset of chronic heart failure at 1, 2, and 3 years was 90%, 80%, 69%, respectively. No significant differences in survival were found between men and women (P=.13). Cox proportional hazard modelling confirmed an increased risk of death with older age (hazard ratio=1.06; 95% confidence interval, 1.06-1.07), diabetes mellitus (hazard ratio=1.53; 95% confidence interval, 1.33-1.76), chronic kidney disease (hazard ratio=1.73; 95% confidence interval, 1.45-2.05), and ischemic heart disease (hazard ratio=1.18; 95% confidence interval, 1.02-1.36). Hypertension (hazard ratio=0,73; 95% confidence interval, 0,64-0,84) had a protective effect.

Conclusions

Service planning and prevention programs should take into consideration the relatively high survival rates found in our area and the effect of prognostic factors that can help to identify high risk patients.Full English text available from:www.revespcardiol.org/en     

Valor pronóstico de la oclusión total crónica de una arteria no responsable en el infarto agudo de miocardio tratado con angioplastia primaria

Introduction and objectives

The prognostic value of chronic total occlusion in nonculprit coronary arteries in patients with myocardial infarction undergoing primary angioplasty remains controversial. Several publications have described different methodologies and conflicting findings. In addition, causes of death were not reported. Our aim is to analyze the prognostic impact of chronic total occlusion in nonculprit coronary arteries and the role of left ventricular ejection fraction in this analysis.

Methods

Prospective inclusion of consecutive patients with ST-segment elevation myocardial infarction who underwent primary angioplasty. We recorded baseline characteristics, in-hospital clinical course, and mortality and its causes during follow-up. We assessed the impact of chronic total occlusion on mortality using Cox regression analysis.

Results

Chronic total occlusion in nonculprit arteries was present in 125 of 1176 patients (10.6%); in 79 of these 125 patients, chronic total occlusion was present in the proximal segments. The mean follow-up was 339 days; 64 (5.8%) patients died during the first 6 months. Patients with chronic total occlusions had more comorbidities, poorer ventricular function, and higher mortality (hazard ratio=2.79; 95% confidence interval, 1.71-4.56). Chronic total occlusion was also associated with noncardiac death (hazard ratio=3.83; 95% confidence interval, 2.10-7.01). Chronic total occlusion in proximal segments was associated with both cardiac (hazard ratio=3.22; 95% confidence interval, 1.42-7.30) and noncardiac deaths (hazard ratio=3.43; 95% confidence interval, 1.67-7.06). The multivariate analysis performed without including left ventricular ejection fraction showed a significant association between chronic total occlusion and mortality. However, when left ventricular ejection fraction was included in the analysis, this association was nonsignificant (hazard ratio=1.76; 95% confidence interval, 0.85-3.65; P=.166).

Conclusions

Chronic total occlusion in this clinical setting identified patients at higher risk with more comorbidities and higher mortality, but did not behave as an independent predictor of mortality when left ventricular ejection fraction was included in the analysis.Full English text available from:www.revespcardiol.org/en     

Association Between Drug-Eluting Stent Type and Clinical Outcomes in Patients With Chronic Kidney Disease Undergoing Percutaneous Coronary Intervention

Background

The comparative efficacy of first- vs second-generation drug-eluting stents (DESs) in patients with chronic kidney disease (CKD) undergoing percutaneous coronary intervention (PCI) is unknown.

Methods

A retrospective analysis of consecutive patients undergoing PCI at a tertiary PCI center from 2007-2011 was performed, with linkage to administrative databases for long-term outcomes. CKD was defined as creatinine clearance (CrCl) < 60 mL/min. Propensity matching by multivariable scoring method and Kaplan-Meier analyses were performed.

Results

Of 6481 patients with available CrCl values undergoing a first PCI during the study period, 1658 (25%) had CKD. First- and second-generation DESs were implanted in 320 (19.3%) and 128 (7.7%) patients with CKD, respectively. At 2 years, no significant differences were observed between first-generation (n = 126) and second-generation (n = 126) propensity-matched DES cohorts for the outcomes of death (19% vs 16%; P = 0.51), repeat revascularization (10% vs 10%; P = 1.00), and major adverse cardiovascular and cerebrovascular events (MACCE) (36% vs 37%; P = 0.90). The 2-year Kaplan-Meier survival was also similar (P = 0.77). In patients with CKD, second-generation DES type was not an independent predictor for death (P = 0.49) or MACCE (P = 1.00).

Conclusions

Although the use of first- and second-generation DESs was associated with similar 2-year safety and efficacy in patients with CKD, our results cannot rule out a beneficial effect of second- vs first-generation DESs owing to small sample size. Future studies with larger numbers of patients with CKD are needed to identify optimal stent types, which may improve long-term clinical outcomes.     

Higher Neutrophil/Lymphocyte Ratio Is Related to Lower Ejection Fraction and Higher Long-term All-Cause Mortality in ST-Elevation Myocardial Infarction Patients

Background

Neutrophil/lymphocyte ratio (NLR) is a novel biomarker that can single out individuals at risk for vascular events. We assessed whether NLR provides additive prognostic value in patients with ST-elevation myocardial infarction (STEMI).

Methods

NLR was computed from the absolute values of neutrophils and lymphocytes from the complete blood count of patients who underwent primary coronary angioplasty for STEMI. The cohort was divided into 2 groups according to NLR (NLR ≥ 6.5%, NLR < 6.5%) using χ² automatic interaction detection. The association between NLR and in-hospital clinical complications and left ventricular ejection fraction (EF) was assessed using logistic regression. The association between NLR, 30-day and 5-year all-cause mortality were analyzed using Cox regression models, adjusting for potential clinical, metabolic, and inflammatory confounders.

Results

In a group of 538 consecutive STEMI patients, high NLR (NLR ≥ 6.5%) was independently associated with increased 30-day and 5-years mortality rates (odds ratio, 15.8; 95% confidence interval, 1.6-154; P = 0.018; and hazard ratio, 2.2; 95% confidence interval, 1.04-4.8; P = 0.039, respectively). High NLR was also independently associated with lower EF (49 ± 8 vs 46 ± 8; P < 0.001) and fewer hospital complications.

Conclusions

In patients presenting with STEMI, high NLR was independently associated with lower EF, fewer hospital complications, and higher mortality rates up to 5 years. NLR value appears additive to conventional risk factors and commonly used biomarkers.     

Systematic use of a collagen-based vascular closure device immediately after cardiac catheterization procedures in 1,317 consecutive patients.

Despite recent advances in interventional cardiology, vascular access complications continue to be a significant problem. Conventional manual compression of the femoral access site is associated with prolonged immobilization and significant patient discomfort. We investigated the performance of a collagen-based closure device applied immediately after catheterization and its complication rate in 1,317 consecutive patients undergoing cardiac catheterization or coronary angioplasty. Patients undergoing coronary angioplasty (n = 644) received more heparin than patients with diagnostic cardiac catheterization (n = 673; 9,675 +/- 1,144 IU vs. 6,419 +/- 2,211 IU; P < 0.0001). Deployment success rates of the closure device were comparable for patients undergoing diagnostic vs. interventional procedures (95.8% vs. 96.7%; P = 0.46). Complete hemostasis immediately after deployment of the device was achieved in > 90% of all patients, but was lower in the interventional group (93.7% vs. 90.6%; P = 0.05). Major complications including any vascular surgery, major bleeding requiring transfusion, retroperitoneal hematoma, thrombosis or loss of distal pulses, groin infections, significant groin hematoma, and death were observed in 0.53% of all patients, with no differences between diagnostic or interventional patients (0.62% vs. 0.45%; P = 0.953). Subgroup analysis revealed female gender as a predictor of access site complications. Systematic sealing of femoral access sites after both diagnostic and interventional procedures allows for immediate sheath removal with reliable hemostasis. The use of a collagen-based closure device is associated with a low rate of clinically significant complications.     

Initial experience with the Cardiva Boomerang vascular closure device in diagnostic catheterization.

OBJECTIVES: The authors studied the safety and efficacy of the Cardiva Boomerang vascular closure device in patients undergoing diagnostic cardiac catheterization. BACKGROUND: Conventional vascular closure devices (sutures, collagen plugs, or metal clips) have been associated with catastrophic complications including arterial occlusion and foreign body infections; furthermore, they cannot be utilized in patients with peripheral vascular disease or vascular access site in a vessel other than the common femoral artery. The Cardiva Boomerang device facilitates vascular hemostasis without leaving any foreign body behind at the access site, can be used in peripheral vascular disease, and can be used in vessels other than the common femoral artery METHODS: A total of 96 patients undergoing transfemoral diagnostic cardiac catheterization were included in this study, including 25 (26%) patients with contraindications to conventional closure devices. Femoral angiography was performed prior to deployment of the Cardiva Boomerang closure device. Patients were ambulated at 1 hr after hemostasis was achieved. RESULTS: The device was successfully deployed and hemostasis achieved with the device alone in 95 (99%) patients. The device failed to deploy in 1 (1%) patient and required conversion to standard manual compression. Minor complications were observed in 5 (5%) patients. No patients experienced major complications including femoral hematoma > 4 cm, red blood cell transfusion, retroperitoneal bleed, arteriovenous fistula, pseudoaneurysm, infection, arterial occlusion, or vascular surgery. CONCLUSIONS: The Cardiva Boomerang device is safe and effective in patients undergoing diagnostic cardiac catheterization using the transfemoral approach, facilitating early ambulation with low rates of vascular complications.