Long term clinical outcome of sirolimus drug coated balloons in large coronary vessels.

BACKGROUND: Studies evaluating the safety and efficacy of drug coating balloons (DCB) for the treatment of lesions in large coronary vessel are limited. AIMS: Our study aimed to evaluate the performance of a sirolimus DCB in large coronary arteries. METHODS: We analyzed all the procedures included in the EASTBOURNE Registry (NCT03085823) enrolling patients with a clinical indication to percutaneous coronary intervention performed by a sirolimus DCB according to investigator judgment. In the present analysis, a cut-off of 2.75 mm was used to define large coronary arteries. Primary endpoint of the study was clinically driven target lesion revascularization (TLR) at 24 months whereas secondary endpoint included procedural success, myocardial infarction (MI), cardiac death and total mortality. RESULTS: Among the 2123 patients and 2440 lesions enrolled in the EASTBOURNE study between 2016 and 2020, 757 patients/810 lesions fulfilled the criteria for the present analysis. Mean reference vessel diameter was 3.2 ± 0.3 mm with mean lesion length of 22 ± 7 mm. Procedural success was high (96%) and at 2-year follow up the device showed a good efficacy with a TLR rate of 9%. There were 34 deaths (4.5%), 30 MIs (4%) and 8 BARC type 3-5 bleedings (1.1%). In-stent restenosis (629 lesions) and de novo lesions (181) were associated with 11% and 4% rates of TLR at 2 years, respectively (p = 0.003). CONCLUSIONS: Clinical performance of a sirolimus DCB in large coronary artery vessels shows promising signals at 2-year follow up, both in de novo and in-stent restenosis lesions.

A Prospective, Multicenter, Real-World Registry of Coronary Lithotripsy in Calcified Coronary Arteries: The REPLICA-EPIC18 Study.

BACKGROUND: Intravascular lithotripsy (IVL) has demonstrated effectiveness in the treatment of calcified lesions in selected patients with stable coronary disease. OBJECTIVES: The authors sought to assess the performance of coronary IVL in calcified coronary lesions in a real-life, all comers, setting. METHODS: The REPLICA-EPIC18 study prospectively enrolled consecutive patients treated with IVL in 26 centers in Spain. An independent core laboratory performed the angiographic analysis and event adjudication. The primary effectiveness endpoint assessed procedural success (successful IVL delivery, final diameter stenosis <20%, and absence of in-hospital major adverse cardiovascular events [MACE]). The primary safety endpoint measured freedom from MACE at 30 days. A predefined substudy compared outcomes between acute coronary syndrome (ACS) and chronic coronary syndrome (CCS) patients. RESULTS: A total of 426 patients (456 lesions) were included, 63% of the patients presenting with ACS. IVL delivery was successful in 99% of cases. Before IVL, 49% of lesions were considered undilatable. The primary effectiveness endpoint was achieved in 66% of patients, with similar rates among CCS patients (68%) and ACS patients (65%). Likewise, there were no significant differences in angiographic success after IVL between CCS and ACS patients. The rate of MACE at 30 days (primary safety endpoint) was 3% (1% in CCS and 5% in ACS patients [P = 0.073]). CONCLUSIONS: Coronary IVL proved to be a feasible and safe procedure in a "real-life" setting, effectively facilitating stent implantation in severely calcified lesions. Patients with ACS on admission showed similar angiographic success rates but showed a trend toward higher 30-day MACE compared with patients with CCS. (REPLICA-EPIC18 study [Registry of Coronary Lithotripsy in Spain]; NCT04298307).

Sirolimus-coated balloon in acute and chronic coronary syndromes: subanalysis of the EASTBOURNE registry.

INTRODUCTION AND OBJECTIVES: The PEACE study (Performance of a sirolimus-eluting balloon strategy in acute and chronic coronary syndromes) investigated for the first time whether a sirolimus-coated balloon (SCB) (Magic Touch, Concept Medical, India) is associated with different outcomes depending on whether it is used in acute coronary syndromes (ACS) or chronic coronary syndromes (CCS). METHODS: This was a post-hoc analysis from the all-comers EASTBOURNE Registry (NCT03085823). Out of 2083 patients enrolled, an SCB was used to treat 968 (46.5%) ACS and 1115 (53.5%) CCS patients. The primary endpoint was target lesion revascularization at 12 months, while secondary endpoints were angiographic success and major adverse cardiovascular events. RESULTS: Baseline demographics, mean reference vessel diameter and mean lesion length were comparable between ACS and CCS. Predilatation was more commonly performed in ACS (P=.007). SCB was inflated at a standard pressure in both groups with a slight trend toward longer inflation time in ACS. Angiographic success was high in both groups (ACS 97.4% vs CCS 97.7%, P=.820) with limited bailout stenting. Similarly, at 12 months the cumulative incidence of target lesion revascularization (ACS 6.6% vs CCS 5.2%, P=.258) was comparable between ACS and CCS. Conversely, a higher rate of major adverse cardiovascular events in acute presenters was mainly driven by myocardial infarction recurrencies (ACS 10.4% vs CCS 8.3%, P=.009). In-stent restenosis showed a higher proportion of target lesion revascularization and major adverse cardiovascular events than de novo lesions, independently of the type of presentation at the index procedure. CONCLUSIONS: This SCB shows good performance in terms of acute and 1-year outcomes independently of the clinical presentation.

Sirolimus-Coated Balloon in an All-Comer Population of Coronary Artery Disease Patients: The EASTBOURNE Prospective Registry.

BACKGROUND: Drug-coated balloons (DCB) represent 1 of the most promising innovations in interventional cardiology and may represent a valid alternative to drug-eluting stents. Currently, some sirolimus-coated balloons (SCB) are being investigated for several coronary artery disease applications. OBJECTIVES: This study sought to understand the role of a novel SCB for the treatment of coronary artery disease. METHODS: EASTBOURNE (All-Comers Sirolimus-Coated Balloon European Registry) is a prospective, multicenter, investigator-driven clinical study that enrolled real-world patients treated with SCB. Primary endpoint was target lesion revascularization (TLR) at 12 months. Secondary endpoints were procedural success, myocardial infarction (MI), all-cause death, and major adverse clinical events (a composite of death, MI, and TLR). All adverse events were censored and adjudicated by an independent clinical events committee. RESULTS: A total population of 2,123 patients (2,440 lesions) was enrolled at 38 study centers in Europe and Asia. The average age was 66.6 ± 11.3 years, and diabetic patients were 41.5%. De novo lesions (small vessels) were 56%, in-stent restenosis (ISR) 44%, and bailout stenting occurred in 7.7% of the patients. After 12 months, TLR occurred in 5.9% of the lesions, major adverse clinical events in 9.9%, and spontaneous MI in 2.4% of the patients. The rates of cardiac/all-cause death were 1.5% and 2.5%, respectively. The primary outcome occurred more frequently in the ISR cohort (10.5% vs 2.0%; risk ratio: 1.90; 95% CI: 1.13-3.19). After multivariate Cox regression model, the main determinant for occurrence of the primary endpoint was ISR (OR: 5.5; 95% CI: 3.382-8.881). CONCLUSIONS: EASTBOURNE, the largest DCB study in the coronary field, shows the safety and efficacy of a novel SCB in a broad population of coronary artery disease including small vessels and ISR patients at mid-term follow-up. (The All-Comers Sirolimus-Coated Balloon European Registry [EASTBOURNE]; NCT03085823).

Changes in the Treatment Strategy Following Intracoronary Pressure Wire in a Contemporaneous Real-Life Cohort of Patients With Intermediate Coronary Stenosis. Results From a Nationwide Registry.

BACKGROUND: Intracoronary pressure wire is useful to guide revascularization in patients with coronary artery disease. AIMS: To evaluate changes in diagnosis (coronary artery disease extent), treatment strategy and clinical results after intracoronary pressure wire study in real-life patients with intermediate coronary artery stenosis. METHODS: Observational, prospective and multicenter registry of patients in whom pressure wire was performed. The extent of coronary artery disease and the treatment strategy based on clinical and angiographic criteria were recorded before and after intracoronary pressure wire guidance. 12-month incidence of MACE (cardiovascular death, non-fatal myocardial infarction or new revascularization of the target lesion) was assessed. RESULTS: 1414 patients with 1781 lesions were included. Complications related to the procedure were reported in 42 patients (3.0 %). The extent of coronary artery disease changed in 771 patients (54.5 %). There was a change in treatment strategy in 779 patients (55.1 %) (18.0 % if medical treatment; 68.8 % if PCI; 58.9 % if surgery (p < 0.001 for PCI vs medical treatment; p = 0.041 for PCI vs CABG; p < 0.001 for medical treatment vs CABG)). In patients with PCI as the initial strategy, the change in strategy was associated with a lower rate of MACE (4.6 % vs 8.2 %, p = 0.034). CONCLUSIONS: The use of intracoronary pressure wire was safe and led to the reclassification of the extent of coronary disease and change in the treatment strategy in more than half of the cases, especially in patients with PCI as initial treatment.

Prospective application of a bleeding and ischemic risks-adjusted antithrombotic protocol in elderly patients revascularized with everolimus-eluting stents: EPIC05-Sierra75 study.

OBJECTIVES: Elderly patients show a higher incidence of ischemic and bleeding events after percutaneous transluminal coronary intervention (PCI). We sought to investigate outcomes in elderly patients treated with antithrombotic strategy guided by bleeding and ischemic risks after revascularization with last generation everolimus-eluting stent (EES). METHODS: Prospective multicenter registry including patients over 75 years revascularized with EES and antithrombotic therapy guided by clinical presentation, PCI complexity and PRECISE DAPT score. Co-primary safety endpoints were: (1) composite of cardiac death, myocardial infarction and stent thrombosis and; (2) bleeding (BARC 2-5). Primary efficacy endpoint was target lesion revascularization. A matched group of patients revascularized with current drug-eluting stents and no such tailored antithrombotic therapy was used as control. RESULTS: Finally, 1064 patients were included in SIERRA-75 cohort, 80.8 ± 4.2 years, 36.6% women, 71% acute coronary syndromes (ACS) and 53.6% complex PCI. Co-primary safety endpoint of major adverse cardiovascular events was met in 6.2%, co-primary safety endpoint of bleeding in 7.8% and primary efficacy endpoint of TKLR in 1.5%. The multivariable adjusted model showed no significant association of the prescribed short/long dual antiplatelet therapy (DAPT) durations with any endpoint suggesting a well tailored therapy. No stent thrombosis reported in the subgroup with 1-3 months DAPT duration. As compared to control group, bleeding BARC 2-5 was significantly lower in SIERRA-75 group (7.4% vs. 10.2%, P = 0.04) as well as the net safety-efficacy endpoint (14.3% vs. 18.5%, P = 0.02). CONCLUSIONS: In elderly population, the application of this risks-adjusted antithrombotic protocol after revascularization with last generation EES seems to be associated with an improved prognosis in terms of ischemic and bleeding outcomes.

Angiography-derived physiology guidance vs usual care in an All-comers PCI population treated with the healing-targeted supreme stent and Ticagrelor monotherapy: PIONEER IV trial design.

BACKGROUND: Current ESC guidelines recommend the use of intra-coronary pressure guidewires for functional assessment of intermediate-grade coronary stenoses. Angiography-derived quantitative flow ratio (QFR) is a novel method of assessing these stenoses, and guiding percutaneous coronary intervention (PCI). METHODS/DESIGN: The PIONEER IV trial is a prospective, all-comers, multi-center trial, which will randomize 2,540 patients in a 1:1 ratio to PCI guided by angiography-derived physiology or usual care, with unrestricted use in both arms of the Healing-Targeted Supreme sirolimus-eluting stent (HT Supreme). The stent's fast, biologically healthy, and robust endothelial coverage allows for short dual-antiplatelet therapy (DAPT); hence the antiplatelet regimen of choice is 1-month DAPT, followed by ticagrelor monotherapy. In the angiography-derived physiology guided arm, lesions will be functionally assessed using on-line QFR, with stenting indicated in lesions with a QFR ≤0.80. Post-stenting, QFR will be repeated in the stented vessel(s), with post-dilatation or additional stenting recommended if the QFR<0.91 distal to the stent, or if the delta QFR (across the stent) is >0.05. Usual care PCI is performed according to standard clinical practice. The primary endpoint is a non-inferiority comparison of the patient-oriented composite endpoint (POCE) of all-cause death, any stroke, any myocardial infarction, or any clinically, and physiologically driven revascularization with a non-inferiority risk-difference margin of 3.2%, at 1-year post-procedure. Clinical follow-up will be up to 3 years. SUMMARY: The PIONEER IV trial aims to demonstrate non-inferiority of QFR-guided PCI to usual care PCI with respect to POCE at 1-year in patients treated with HT Supreme stents and ticagrelor monotherapy. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov UNIQUE IDENTIFIER: NCT04923191 CLASSIFICATIONS: Interventional Cardiology.

Amphilimus- vs. zotarolimus-eluting stents in patients with diabetes mellitus and coronary artery disease: the SUGAR trial.

AIM: Patients with diabetes mellitus are at high risk of adverse events after percutaneous revascularization, with no differences in outcomes between most contemporary drug-eluting stents. The Cre8 EVO stent releases a formulation of sirolimus with an amphiphilic carrier from laser-dug wells, and has shown clinical benefits in diabetes. We aimed to compare Cre8 EVO stents to Resolute Onyx stents (a contemporary polymer-based zotarolimus-eluting stent) in patients with diabetes. METHODS AND RESULTS: We did an investigator-initiated, randomized, controlled, assessor-blinded trial at 23 sites in Spain. Eligible patients had diabetes and required percutaneous coronary intervention. A total of 1175 patients were randomly assigned (1:1) to receive Cre8 EVO or Resolute Onyx stents. The primary endpoint was target-lesion failure, defined as a composite of cardiac death, target-vessel myocardial infarction, and clinically indicated target-lesion revascularization at 1-year follow-up. The trial had a non-inferiority design with a 4% margin for the primary endpoint. A superiority analysis was planned if non-inferiority was confirmed. There were 106 primary events, 42 (7.2%) in the Cre8 EVO group and 64 (10.9%) in the Resolute Onyx group [hazard ratio (HR): 0.65, 95% confidence interval (CI): 0.44-0.96; Pnon-inferiority < 0.001; Psuperiority = 0.030]. Among the secondary endpoints, Cre8 EVO stents had significantly lower rate than Resolute Onyx stents of target-vessel failure (7.5% vs. 11.1%, HR: 0.67, 95% CI: 0.46-0.99; P = 0.042). Probable or definite stent thrombosis and all-cause death were not significantly different between groups. CONCLUSION: In patients with diabetes, Cre8 EVO stents were non-inferior to Resolute Onyx stents with regard to target-lesion failure composite outcome. An exploratory analysis for superiority at 1 year suggests that the Cre8 EVO stents might be superior to Resolute Onyx stents with regard to the same outcome. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov: NCT03321032.

Clinical performance of a novel sirolimus-coated balloon in coronary artery disease: EASTBOURNE registry.

AIMS: The purpose of the EASTBOURNE registry is to evaluate the immediate and long-term clinical performance of a novel sirolimus-coated balloon (SCB) in a real-world population of patients with coronary artery disease. We here present the prespecified interim analysis after the enrollment of the first 642 patients who obtained 1-year clinical follow-up. METHODS: EASTBOURNE is a prospective, international, multicenter, all-comer investigator-driven clinical registry, which is enrolling consecutive patients treated with SCB at 42 European and Asiatic centers. Primary study endpoint is target-lesion revascularization (TLR) at 12 months. Secondary endpoints are procedural success and major adverse cardiac events through 36 months. RESULTS: Diabetes mellitus was present in 41% of patients. Acute coronary syndrome was present in 45% of patients and de novo lesions were 55%; 83% of the in-stent restenosis (ISR) patients had drug-eluting stents restenosis. Lesion predilatation was performed in 95% of the cases and bailout stenting occurred in 7.5%. So far, 642 patients have a complete 12-month follow-up. TLR occurred in 2.5%, myocardial infarction in 2.3%, total death in 1% and major adverse cardiac events in 5.8% of patients. A prespecified analysis of comparison between ISR and de-novo lesions showed a significantly higher occurrence of TLR in the ISR population (5.4 vs. 0.2%, P = 0.0008). CONCLUSION: The current interim analysis of 12-month follow-up of the EASTBOURNE registry shows good immediate performance and an adequate and encouraging safety profile through 12 months for this novel SCB.

Systematic Scoring Balloon Lesion Preparation for Drug-Coated Balloon Angioplasty in Clinical Routine: Results of the PASSWORD Observational Study.

INTRODUCTION: Scoring balloon angioplasty (SBA) for lumen gain prior to stent implantations or drug-coated balloon angioplasty (DCB) is considered an essential interventional tool for lesion preparation. Recent evidence indicates that SBA may play a pivotal role in enhancing the angiographic and clinical outcomes of DCB angioplasty. METHODS: We studied the systematic use of SBA with a low profile, non-slip element device prior to DCB angioplasty in an unselected, non-randomized patient population. This prospective, all-comers study enrolled patients with de novo lesions as well as in-stent restenotic lesions in bare metal stents (BMS-ISR) and drug-eluting stents (DES-ISR). The primary endpoint was the target lesion failure (TLF) rate at 9 months (ClinicalTrials.gov Identifier NCT02554292). RESULTS: A total of 481 patients (496 lesions) were recruited to treat de novo lesions (78.4%, 377), BMS-ISR (4.0%, 19), and DES-ISR (17.6%, 85). Overall risk factors were acute coronary syndrome (ACS, 20.6%, 99), diabetes mellitus (46.8%, 225), and atrial fibrillation (8.5%, 41). Average lesion lengths were 16.7 ± 10.4 mm in the de novo group, and 20.1 ± 8.9 mm (BMS-ISR) and 16.2 ± 9.8 mm (DES-ISR) in the ISR groups. Scoring balloon diameters were 2.43 ± 0.41 mm (de novo), 2.71 ± 0.31 mm (BMS-ISR), and 2.92 ± 0.42 mm (DES-ISR) whereas DCB diameters were 2.60 ± 0.39 mm (de novo), 3.00 ± 0.35 mm (BMS-ISR), and 3.10 ± 0.43 mm (DES-ISR), respectively. The overall accumulated TLF rate of 3.0% (14/463) was driven by significantly higher target lesion revascularization rates in the BMS-ISR (5.3%, 1/19) and the DES-ISR group (6.0%, 5/84). In de novo lesions, the TLF rate was 1.1% (4/360) without differences between calcified and non-calcified lesions (p = 0.158) and small vs. large reference vessel diameters with a cutoff value of 3.0 mm (p = 0.901). CONCLUSIONS: The routine use of a non-slip element scoring balloon catheter to prepare lesions suitable for drug-coated balloon angioplasty is associated with high procedural success rates and low TLF rates in de novo lesions.

[Primary percutaneous angioplasty. An analysis of reperfusion delays, their determining factors and their prognostic implications]. / Angioplastia primaria en nuestro medio. Análisis de los retrasos hasta la reperfusión, sus condicionantes y su implicación pronóstica.

INTRODUCTION AND OBJECTIVES: The optimum treatment for patients with ST-segment elevation acute myocardial infraction (AMI) is primary percutaneous coronary intervention (PCI), provided that the door-to-balloon time is less than 90 min. The aims of this study were to determine actual treatment times in our patients, to investigate the effect of different factors in reducing those times, and to evaluate the impact of any delay on prognosis. METHODS: The study involved patients who underwent primary or rescue PCI at our center between January 2005 and October 2007. Treatment times, clinical and angiographic characteristics, and follow-up findings at 1 and 12 months were recorded prospectively. RESULTS: Overall, 389 PCIs were performed: 361 primary and 28 rescue interventions. The median total duration of ischemia was 235 [interquartile range, 170-335] min. The median door-to-balloon time was 79 [53-104] min. The door-to-balloon time was shorter when the ambulance service was able to notify the on-duty cardiologist, who alerted the interventional cardiology team. The difference was 30 [60-90] min (P< .01). Patients who arrived at the emergency department by their own means had the longest door-to-balloon time (100 min vs. 74 min; P< .01). A door-to-balloon time >120 min was associated with higher mortality at 30 days; multivariate analysis showed a clearly increasing trend. CONCLUSIONS: The door-to-balloon time at our center was in line with current recommendations, with the time being markedly shorter for patients for whom the ambulance service was able to give advanced warning. A shorter time was associated with a trend towards lower 30-day mortality.

Angioplastia primaria en nuestro medio. Análisis de los retrasos hasta la reperfusión, sus condicionantes y su implicación pronóstica / Primary percutaneous angioplasty. An analysis of reperfusion delays, their determining factors and their prognostic implications

Introducción y objetivos. El mejor tratamiento para el IAM con elevación del ST es la ICPP siempre que el tiempo puerta-balón sea < 90 min. Presentamos nuestros tiempos reales y valoramos la influencia de determinados factores en su reducción, y la evolución en relación con el tiempo de demora. Métodos. Hemos recogido de manera prospectiva los tiempos, los datos clínicos y angiográficos y el seguimiento a 1 y 12 meses de los pacientes a los que se realizó una ICPP o de rescate en nuestro centro de enero de 2005 a octubre de 2007. Resultados. Se realizaron 389 angioplastias, 361 primarias y 28 de rescate. La mediana del tiempo de isquemia fue 235 [percentiles 25-75, 170-335] min. La mediana del TPG fue 79 [53-104] min. El TPG fue menor cuando el servicio de transporte urgente avisó al cardiólogo de guardia, quien puso en marcha la alerta de hemodinámica, con una diferencia de 30 [90-60] min (p < 0,01). Los pacientes que llegaron a la urgencia por sus propios medios presentaron el mayor tiempo puerta-guía (100 frente a 74 min; p < 0,01). El tiempo puerta-guía > 120 min se asoció a mayor mortalidad a 30 días y a una clara tendencia a aumentarla en el análisis multivariable. Conclusiones. El tiempo puerta-guía en nuestro medio se ajusta a las recomendaciones vigentes, con una clara reducción cuando el servicio de transporte urgente avisa con antelación. Su reducción se relaciona con una tendencia a una menor mortalidad a 30 días (AU)

Introduction and objectives. The optimum treatment for patients with ST-segment elevation acute myocardial infraction (AMI) is primary percutaneous coronary intervention (PCI), provided that the door-to-balloon time is less than 90 min. The aims of this study were to determine actual treatment times in our patients, to investigate the effect of different factors in reducing those times, and to evaluate the impact of any delay on prognosis. Methods. The study involved patients who underwent primary or rescue PCI at our center between January 2005 and October 2007. Treatment times, clinical and angiographic characteristics, and follow-up findings at 1 and 12 months were recorded prospectively. Results. Overall, 389 PCIs were performed: 361 primary and 28 rescue interventions. The median total duration of ischemia was 235 [interquartile range, 170-335] min. The median door-to-balloon time was 79 [53-104] min. The door-to-balloon time was shorter when the ambulance service was able to notify the on-duty cardiologist, who alerted the interventional cardiology team. The difference was 30 [60-90] min (P<.01). Patients who arrived at the emergency department by their own means had the longest door-to-balloon time (100 min vs. 74 min; P<.01). A door-to-balloon time >120 min was associated with higher mortality at 30 days; multivariate analysis showed a clearly increasing trend. Conclusions. The door-to-balloon time at our center was in line with current recommendations, with the time being markedly shorter for patients for whom the ambulance service was able to give advanced warning. A shorter time was associated with a trend towards lower 30-day mortality (AU)

[Unusual complications of cardiac catheterization via the radial artery]. / Complicaciones inusuales del cateterismo por vía radial.

Use of the radial artery for cardiac catheterization has significantly reduced the incidence and severity of complications at the access site. Nevertheless, occasionally unusual complications or atypical responses to treatment are observed. We describe two cases: a radial artery pseudoaneurysm that was unresponsive to compression treatment and a foreign-body inflammatory reaction at the radial artery access site. The characteristics, development and treatment of the 2 cases are described, and the pathogenic mechanisms are discussed.

Complicaciones inusuales del cateterismo por vía radial / Unusual complications of cardiac catheterization via the radial artery

El uso de la vía transradial para el cateterismo cardíaco ha reducido drásticamente la incidencia y la gravedad de las complicaciones relacionadas con el acceso. No obstante, en ocasiones se producen complicaciones inusuales o cuya respuesta al tratamiento es atípica. Describimos 2 casos: un seudoaneurisma radial refractario al tratamiento compresivo y una reacción inflamatoria a cuerpo extraño en el lugar de la punción arterial. Se ilustran ambos casos, se detallan su evolución y tratamiento y se discute su mecanismo patogénico

Use of the radial artery for cardiac catheterization has significantly reduced the incidence and severity of complications at the access site. Nevertheless, occasionally unusual complications or atypical responses to treatment are observed. We describe two cases: a radial artery pseudoaneurysm that was unresponsive to compression treatment and a foreign-body inflammatory reaction at the radial artery access site. The characteristics, development and treatment of the 2 cases are described, and the pathogenic mechanisms are discussed

Vasoreactivity of the radial artery after transradial catheterization.

The vasomotor response was used to assess the degree of radial artery injury after transradial catheterization. Vasoreactivity was studied by ultrasound before catheterization, 24 hours after, at 1 week and at 1 month in 18 patients. Mean radial artery diameter increased from 2.56+/-0.45 mm before catheterization to 2.86+/-0.48 mm at 24 hours (p=0.001) and returned to baseline values at 1-month (2.60+/-0.27 mm; p=0.95). Hyperemia-induced vasodilation did not change significantly (2.7+/-4.7% at baseline; 3.4+/-3.7% at 24 hours, 3.5+/-3.9% at 1 week and 4.8+/-4.7% at 1 month; p=0.59). Nitroglycerin-induced vasodilation was significantly attenuated at 24 hours (from 14.1+/-7.9% at baseline to 6.5+/-8.4% at 24 hours; p=0.01), but improved after 1 week (9.8+/-8.5%; p=0.1, compared to baseline) and after 1 month (13.0+/-8.9%; p=0.51, compared to baseline). Thus, soon after transradial catheterization vasoreactivity is impaired, but generally recovers as early as 1 month after the procedure.

Validation of 4 French catheters for quantitative coronary analysis: in vivo variability assessment using 6 French guiding catheters as reference scaling devices.

UNLABELLED: Although numerous studies have established the utility of 4 F catheters for routine coronary angiography, its adequacy for automatic quantitative coronary analysis has not been previously assessed. METHODS: In 32 consecutive patients, coronary angiography was performed sequentially with 4 F diagnostic catheters and 6 F guiding catheters after intracoronary nitroglycerin. A total of 43 lesions were evaluated for quantitative analysis using both types of catheter as scaling devices. Possible differences in the reference diameter, minimal luminal diameter and percent diameter stenosis were evaluated. All measurements were performed offline by the same operator and intraobserver variability estimation was performed by repeating the evaluation in 12 lesions randomly selected after 1 month. RESULTS: The mean reference diameter was 2.98+/-0.48 mm, mean minimal luminal diameter was 1.00+/-0.52 mm and percent diameter stenosis was 67.1+/-15.3%. Accuracy (mean difference of values) was 0.009 mm for reference diameter, 0.005 mm for minimal luminal diameter and 0.25% for percent diameter stenosis. Precision (mean standard deviation of the differences) was 0.17 mm for reference diameter, 0.19 mm for minimal luminal diameter and 5.93% for percent stenosis. Linear correlation for these three variables was 0.94, 0.93 and 0.93, respectively. Intraobserver variability analysis showed similar values for accuracy, precision and linear correlation. CONCLUSIONS: Angiography with 4 F catheters allows adequate quantification of luminal diameters as compared to most accepted clinical standards. These results may have implications for the selection of diagnostic catheters for routine follow-up assessment of percutaneous coronary interventions.

Clinical findings as predictors of positivity of head-up tilt table test in neurocardiogenic syncope.

BACKGROUND: Neurocardiogenic (vasovagal) syncope occurs frequently and can be diagnosed with the head-up tilt table (HUTT) test. Our objective in this study was to identify clinical predictors of the positivity of HUTT test in neurocardiogenic syncope. METHODS: We conducted a prospective study of 117 cases (81 women and 36 men, 13-85 years of age) referred to our Institution for HUTT testing. The ability of 10 symptoms and signs of clinical history to predict HUTT positivity were evaluated using logistic regression analysis. RESULTS: We observed a low rate of test-negative cases (24%) and 89 positives. Nearly all positives (87/89) were neurocardiogenic, principally of vasodepressor and mixed types (43 and 34 cases, respectively) and a few were cardioinhibitory (10, mostly young males). Regression analysis established that dizziness, nausea, and diaphoresis in past history were associated with HUTT positivity nearly 25 times more frequently than when absent. CONCLUSIONS: Our three conclusions are that syncope in absence of heart disease accompanied by dizziness, nausea, and diaphoresis may be treated as neurocardiogenic in settings where no HUTT is available. In addition, our low rate of negative tests may have been the result of our reexamining referrals prior to deciding test performance, and high frequency of young males in cardioinhibitory syncope needs further research.

[Value of gated-SPECT in defining the post-revascularization prognosis of patients with ischemic cardiomyopathy]. / Valor del gated-SPECT para definir el pronóstico tras la revascularización en una población con cardiopatía isquémica.

INTRODUCTION AND OBJECTIVES: Gated-SPECT simultaneously evaluates perfusion and ventricular function and could provide important prognostic information in ischemic cardiomyopathy. Our aim was to study the value of gated-SPECT performed before revascularization in a cardioischemic population to predict the outcome of revascularization. METHODS: One hundred and ten patients who had undergone percutaneous (n = 100) or surgical revascularization were included. Patients underwent sestamibi gated-SPECT before revascularization. After revascularization, they were followed-up for at least 12 months (mean 23.7 months, maximum 44 months). We recorded deaths and a combined clinical event of death, non-fatal infarction, and hospital re-admission for cardiac reasons. We analyzed the prognostic value of clinical, angiographic, and gated-SPECT variables. RESULTS: During follow-up, there were 14 deaths (6.4%/ year) and 36 cases of combined events (16.5%/year). Multivariate analysis showed that depressed gated-SPECT ejection fraction (threshold 0.30) was the only variable independently related to death (OR = 4.8; 95%CI, 1.6-14.6) and combined event (OR = 2.5; 95%CI, 1.2-4.8). Survival analysis showed that patients with ejection fraction < or = 0.30% had a significantly shorter period of time free of death (33 months [28-38] versus 42 months [40-44]; p = 0.002) and combined events (28 months [23-32] versus 36 months [33-39]; p = 0.007). CONCLUSIONS: Gated-SPECT, due to the information it provides about left ventricular function, predicts the prognosis of patients after coronary revascularization.