Comparison of outcomes in patients with or without ARC-HBR criteria undergoing PCI with polymer-free biolimus coated stents: The BioFreedom France study.

BACKGROUND: The polymer-free biolimus coated stent (BioFreedom) was shown to be superior to bare metal stents in the LEADERS FREE randomized trial in high bleeding risk (HBR) patients treated with 1-month dual antiplatelet therapy (DAPT). However, there is limited outcome data with this device in an all-comers' population. METHODS: We conducted a prospective single-arm study of patients undergoing percutaneous coronary intervention with the polymer-free biolimus coated stent in 25 centers in France with wide inclusion criteria including multivessel disease, complex lesions, and acute coronary syndromes. The primary endpoint was the incidence of target lesion failure (TLF), a composite of cardiac death or target-vessel myocardial infarction (MI) or clinically indicated target lesion revascularization (ci-TLR) at 1-year. The patient population was classified according to the presence (or not) of HBR criteria according to the recent ARC-HBR definition. RESULTS: Between April 2019 and April 2020, 1497 patients were enrolled. TLF occurred in 101 (6.9%) patients, including cardiac death in 35 (2.4%), target vessel MI in 20 (1.4%) and ci-TLR in 65 (4.5%) of them. There were 491 HBR patients (32.8%) and 1006 non-HBR patients. The median duration of DAPT was 74 days in the HBR group versus 348 days in the non-HBR group (p < 0.0001). TLF occurred in 44 (9.2%) of the HBR group and in 57 (5.8%) of the non-HBR group (relative risk 1.62 [95% confidence interval: 1.10-2.41], p = 0015). Compared to the non-HBR group, HBR patients had higher rates of cardiac death (4.4% vs. 1.4%, p = 0.0005) and target vessel MI (2.9% vs. 0.6%, p = 0.0003), but similar rates of ci-TLR. BARC 3-5 bleeding occurred in 6.2% of the HBR group versus 1.4% of the non-HBR group (p < 0.0001). CONCLUSION: In this multicenter all-comers study, HBR patients treated with a polymer-free biolimus coated stent had, compared to non-HBR patients, an increased risk of cardiac death and MI, and despite a shorter duration of DAPT, continued to have higher rates of BARC 3-5 bleeding.

[Chronic Heart Failure and Telemedecine, remote monitoring : Interest and perspectives]. / Intérêt et avenir de la télésurveillance dans l'insuffisance cardiaque chronique.

Chronic heart failure in France is responsible for 160 000 hospitalizations per year. The treatment of chronic heart failure is multidisciplinary. Telemedicine (TLM) reinforces the therapeutic arsenal of this chronic pathology by the use of remote monitoring (TLS) on patients followed outside the care structure. This paradigm has proven its effectiveness with the help of digital networks and specific algorithms, which communicate through connected tools with the ICC patient. Clinical signs of worsening can trigger an alert that will be taken into account by the TLS. Early intervention on these warning signs avoids acute decompensation and a new hospitalization of the patient. The analysis of the results shows a rate of alerts that require the intervention of TLS teams, from 20 to 35% depending on the centers. The ETAPES program has set the regulatory framework for the TLS experiment for 4 years. It will end at the end of 2021. The feedback from the TLS centers is between 6 and 18 months. The satisfaction index of patients followed by TLS is 95%. The intermediate results (2018, 2019) and the evaluation of the ETAPES program, are in favor of TLS management of ICC patients. Therapeutic education and TLS improve patients' quality of life. The Ministry of Health plans a transition to the common law for TLS in 2022.

Current treatment of symptomatic aortic stenosis in elderly patients: Do risk scores really matter after 80 years of age?

BACKGROUND: According to the guidelines, surgical aortic valve replacement (SAVR) is recommended in patients at low surgical risk (EuroSCORE II<4%), whereas for other patients, the decision between transcatheter aortic valve implantation (TAVI) and surgery should be made by the Heart Team, with TAVI being favoured in elderly patients. AIM: The RAC prospective multicentre survey assessed the respective contributions of age and surgical risk scores in therapeutic decision making in elderly patients with severe symptomatic aortic stenosis. METHODS: In September and October 2016, 1049 consecutive patients aged ≥ 75 years were included in 32 centres with on-site TAVI and surgical facilities. The primary endpoint was the decision between medical management, TAVI or SAVR. RESULTS: Mean age was 84±5 years and 53% of patients were female. The surgical risk was classified as high (EuroSCORE II>8%) in 18% of patients, intermediate (EuroSCORE II 4-8%) in 34% and low (EuroSCORE II≤4%) in 48%. TAVI was preferred in 71% of patients, SAVR in 19% and medical treatment in 10%. The choice of TAVI over SAVR was associated with older age (P<0.0001) and a higher EuroSCORE II (P=0.008). However, the weight of EuroSCORE II in therapeutic decision making markedly decreased after the age of 80 years. Indeed, 77% of patients aged ≥ 80 years were referred for TAVI, despite a low estimated surgical risk. CONCLUSIONS: The impact of risk scores depends strongly on age, and decreases considerably after 80 years, most patients being referred for TAVI, independent of their estimated surgical risk. Despite medical advancements, 10% of patients were still denied any intervention.

A novel personalized approach to cardiovascular prevention: The VIVOPTIM programme.

BACKGROUND: Cardiovascular diseases are a leading cause of mortality, but a substantial proportion are preventable. AIMS: The Mutuelle générale de l'éducation nationale (MGEN), a provider of private health insurance in France, has developed the VIVOPTIM programme, a novel digital approach to healthcare based on individualized, multiprofessional, ranked management of cardiovascular risk factors. METHODS: Between November 2015 and June 2016, eligible individuals (age 30-70 years) from two regions of France were invited to participate. Volunteers completed a questionnaire based on the Framingham Heart Study Risk Score and were assigned to one of three cardiovascular risk levels. VIVOPTIM comprises four components: cardiovascular risk assessment, instruction on cardiovascular diseases and associated risk factors, personalized coaching (telephone sessions with a specially trained healthcare professional to provide information on risk factors and disease management, set individual health targets, monitor progress and motivate participants), and e-Health monitoring. RESULTS: Data from 2240 participants were analysed. Significant benefits were observed on mean systolic blood pressure (-3.4mmHg), weight (-1.5kg), smoking (-2.2 cigarettes/day) and daily steps (+1726 steps/day (all P<0.0001)), though not on weekly duration of exercise (-0.2hours/week, P=0.619). CONCLUSION: As a result of the positive mid-to-long-term results of the pilot programme on weight, smoking, blood pressure, and uptake of physical activity, the VIVOPTIM programme was extend to the whole of France in 2018 and has the potential to have a genuine impact on patient care and organization of the healthcare system in France.

Five-year clinical outcome of multicenter randomized trial comparing amphilimus - with paclitaxel-eluting stents in de novo native coronary artery lesions.

OBJECTIVES: Long-term data from randomized studies on polymer-free stents are scarce. Long-term data of Cre8 amphilimus eluting stent are still not available. We sought to investigate contribution of a polymer-free design versus a permanent-polymer one on the long-term. METHODS AND RESULTS: Patients undergoing percutaneous coronary intervention for de novo lesions were randomized 1:1 to Cre8 or Taxus Liberté (323 overall, 126 Cre8). Original primary endpoint (6-month angiographic in-stent late lumen loss) already demonstrated the superiority of Cre8 vs Taxus (0.14 + 0.36 mm vs. 0.34 + 0.40 mm; p < 0.001). Secondary endpoints were the device oriented composite endpoint (DOCE), patient oriented composite endpoint (POCE) up to 5-year. Long-term follow-up data confirmed the superiority shown by Cre8 in the analysis of the angiographic endpoint at 6-month, especially in the diabetic patients, where the device strongly reduced the clinical difference with non-diabetic. Landmark analysis demonstrated that the incidence of DOCE after 1-year and up to 5-year follow up was significantly lower in patients implanted with Cre8 AES (2.1% Cre8 vs. 9.3% Taxus, p = 0.009). While no differences were found in terms of DOCE rate among diabetic and non-diabetic patients treated with the Cre8 AES (HR 1.039; 95%CI 0.320-3.374), this was not true for Taxus (HR 2.64; 95%CI 1.112-6.278). CONCLUSIONS: Cre8 showed favourable safety and efficacy results versus Taxus at 5-years follow-up, with a superior clinical performance for the DOCE endpoint from 1 to 5 years. Cre8, differently from Taxus, has been able to strongly reduce the differences in clinical outcome between diabetic and non-diabetic up to 5 years, suggesting the higher efficacy of Cre8 in the treatment of diabetic patients.

Temporal Trends in Transcatheter Aortic Valve Replacement in France: FRANCE 2 to FRANCE TAVI.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is standard therapy for patients with severe aortic stenosis who are at high surgical risk. However, national data regarding procedural characteristics and clinical outcomes over time are limited. OBJECTIVES: The aim of this study was to assess nationwide performance trends and clinical outcomes of TAVR during a 6-year period. METHODS: TAVRs performed in 48 centers across France between January 2013 and December 2015 were prospectively included in the FRANCE TAVI (French Transcatheter Aortic Valve Implantation) registry. Findings were further compared with those reported from the FRANCE 2 (French Aortic National CoreValve and Edwards 2) registry, which captured all TAVRs performed from January 2010 to January 2012 across 34 centers. RESULTS: A total of 12,804 patients from FRANCE TAVI and 4,165 patients from FRANCE 2 were included in this analysis. The median age of patients was 84.6 years, and 49.7% were men. FRANCE TAVI participants were older but at lower surgical risk (median logistic European System for Cardiac Operative Risk Evaluation [EuroSCORE]: 15.0% vs. 18.4%; p < 0.001). More than 80% of patients in FRANCE TAVI underwent transfemoral TAVR. Transesophageal echocardiography guidance decreased from 60.7% to 32.3% of cases, whereas more recent procedures were increasingly performed in hybrid operating rooms (15.8% vs. 35.7%). Rates of Valve Academic Research Consortium-defined device success increased from 95.3% in FRANCE 2 to 96.8% in FRANCE TAVI (p < 0.001). In-hospital and 30-day mortality rates were 4.4% and 5.4%, respectively, in FRANCE TAVI compared with 8.2% and 10.1%, respectively, in FRANCE 2 (p < 0.001 for both). Stroke and potentially life-threatening complications, such as annulus rupture or aortic dissection, remained stable over time, whereas rates of cardiac tamponade and pacemaker implantation significantly increased. CONCLUSIONS: The FRANCE TAVI registry provided reassuring data regarding trends in TAVR performance in an all-comers population on a national scale. Nonetheless, given that TAVR indications are likely to expand to patients at lower surgical risk, concerns remain regarding potentially life-threatening complications and pacemaker implantation. (Registry of Aortic Valve Bioprostheses Established by Catheter [FRANCE TAVI]; NCT01777828).

Management of Takotsubo cardiomyopathy in non-academic hospitals in France: The Observational French SyndromEs of TakoTsubo (OFSETT) study.

BACKGROUND: Takotsubo cardiomyopathy (TTC) is a rare condition characterized by a sudden temporary weakening of the heart. TTC can mimic acute myocardial infarction and is associated with a minimal release of myocardial biomarkers in the absence of obstructive coronary artery disease. AIMS: To provide an extensive description of patients admitted to hospital for TTC throughout France and to study the management and outcomes of these patients. METHODS: In 14 non-academic hospitals, we collected clinical, electrocardiographic, biological, psychological and therapeutic data in patients with a diagnosis of TTC according to the Mayo Clinic criteria. RESULTS: Of 117 patients, 91.5% were women, mean ± SD age was 71.4 ± 12.1 years and the prevalence of risk factors was high (hypertension: 57.9%, dyslipidaemia: 33.0%, diabetes: 11.5%, obesity: 11.5%). The most common initial symptoms were chest pain (80.5%) and dyspnoea (24.1%). A triggering psychological event was detected in 64.3% of patients. ST-segment elevation was found in 41.7% of patients and T-wave inversion in 71.6%. Anterior leads were most frequently associated with ST-segment elevation, whereas T-wave inversion was more commonly associated with lateral leads, and Q-waves with septal leads. The ratio of peak B-type natriuretic peptide (BNP) or N-terminal prohormone BNP (NT-proBNP) level to peak troponin level was 1.01. No deaths occurred during the hospital phase. After 1 year of follow-up, 3 of 109 (2.8%) patients with available data died, including one cardiovascular death. Rehospitalizations occurred in 17.4% of patients: 2.8% due to acute heart failure and 14.7% due to non-cardiovascular causes. There was no recurrence of TTC. CONCLUSIONS: This observational study of TTC included primarily women with atherosclerotic risk factors and mental stress. T-wave inversion was more common than ST-segment elevation. There were few adverse cardiovascular outcomes in these patients after 1-year follow-up.

Patient exposure to X-rays during coronary angiography and percutaneous transluminal coronary intervention: results of a multicenter national survey.

OBJECTIVES: To evaluate practices for the protection from radiation of patients during coronary angiography (CA) and percutaneous coronary intervention (PCI), and to update reference values for the main radiation dose parameters. BACKGROUND: Few multicenter data from large populations exist on radiation doses to patients during CA and PCI. METHODS: RAY'ACT is a multicenter, nationwide French survey, with retrospective analysis of radiation parameters routinely registered in professional software from 33,937 CAs and 27,826 PCIs performed at 44 centers from January 1, through December 31, 2010. RESULTS: Kerma-area product (KAP) was registered in 91.7% (44/48) of centers and in 91.5% of procedures for CA (median, 27.2 Gy·cm(2) , interquartile range [IQR], 15.5-45.2) and 91.1% for PCI (median, 56.8 Gy·cm(2) , IQR, 32.8-94.6). Fluoroscopy time was registered in 87.5% (42/48) of centers and in 83.1% of procedures (median, 3.7 min, IQR, 2.3-6.3 for CA; 10.3 min, 6.7-16.2 for PCI). Variability across centers was high. Old equipment and routine left ventriculography were more common and number of registered frames and frame rate were higher in centers delivering high doses. The radial route was associated with lower doses than the femoral route (median KAP 26.8 Gy·cm(2) [15.1-44.25] vs. 28.1 [16.4-46.9] for CA, respectively; and 55.6 Gy·cm(2) [32.2-92.1] vs. 59.4 [24.6-99.9] for PCI, respectively; P < 0.01). CONCLUSIONS: This survey showed a very high rate of compliance with dose registration during CA and PCI in French nonacademic hospitals. Updated diagnostic reference values are established for the main dose parameters (KAP, 45 Gy·cm(2) for CA, 95 Gy·cm(2) for PCI).

A multicenter randomized trial comparing amphilimus- with paclitaxel-eluting stents in de novo native coronary artery lesions.

OBJECTIVES: This study sought to demonstrate the noninferiority of polymer-free amphilimus-eluting stents (Cre8, CID, Saluggia, Italy) versus permanent-polymer paclitaxel-eluting stents (Taxus Liberté, Boston Scientific, Natick, Massachusetts) in de novo percutaneous coronary intervention. BACKGROUND: Although the efficacy of the drug-eluting stent has been well established, the risk-benefit balance is still suboptimal, and the safety of polymers remains uncertain. METHODS: Patients undergoing percutaneous coronary intervention for de novo lesions were randomly assigned 1:1 to Cre8 or Taxus Liberté stents. Primary endpoint was 6-month angiographic in-stent late lumen loss (LLL) within a noninferiority scope. Six-month intravascular ultrasound was performed in 20% of the patients. All patients will be clinically followed up to 5 years. RESULTS: Out of 323 patients enrolled, 162 received Cre8 and 161 Taxus Liberté stents. In-stent LLL was significantly lower in Cre8 group (0.14 ± 0.36 mm vs. 0.34 ± 0.40 mm, p noninferiority <0.0001, p superiority <0.0001). Clinical endpoints (cardiac death, myocardial infarction, target lesion revascularization, and stent thrombosis) up to 12 months did not differ significantly between the groups. CONCLUSIONS: The Cre8 stent in de novo lesions showed significantly lower in-stent LLL at 6 months than the Taxus Liberté stent did, with a trend toward better 12-month clinical safety and efficacy results. (International Randomized Comparison Between DES Limus Carbostent and Taxus Drug-Eluting Stents in the Treatment of De Novo Coronary Lesions [NEXT]; NCT01373502).

Early and long-term results of unprotected left main coronary artery stenosis with paclitaxel-eluting stents: the FRIEND (French multicentre RegIstry for stenting of uNprotecteD LMCA stenosis) registry.

AIMS: To evaluate the angiographic and clinical outcome of patients undergoing paclitaxel-eluting stent (PES) implantation for unprotected left main coronary artery (ULMCA) stenosis in a "real-world" multicentre, prospective registry. Percutaneous coronary intervention (PCI) is an increasingly utilised method of revascularisation in patients with ULMCA. METHODS AND RESULTS: A prospective registry including all patients with a significant (>50%) ULMCA stenosis. Of 151 such patients, the target lesion involved the distal bifurcation in 100 patients (66%), which was treated predominantly by a "provisional T-stenting" strategy. In the distal ULMCA disease group, 72% had only one stent implantation while 28% had multiple (either two or three) stents implanted. At a median follow-up of 1,123±80 days, cardiac death occurred in five patients (3.3%) and major adverse cardiac and cerebrovascular events (MACCE) in 32 patients (21.2%). The three-year survival rate was 93.3%. CONCLUSIONS: In the drug-eluting stent era, paclitaxel-eluting stent implantation of ULMCA stenosis provided excellent immediate and long-term results in this selected population, suggesting that this approach may be considered as a safe and effective alternative to CABG for selected patients with ULMCA who are treated in experienced institutions performing large numbers of PCI procedures.

Robotically-assisted coronary artery bypass grafting.

Objectives. Robotic surgery enables to perform coronary surgery totally endoscopically. This report describes our experience using the da Vinci system for coronary artery bypass surgery. Methods. Patients requiring single-or-double vessel revascularization were eligible. The procedure was performed without cardiopulmonary bypass on a beating heart. Results. From April 2004 to May 2008, fifty-six patients were enrolled in the study. Twenty-four patients underwent robotic harvesting of the mammary conduit followed by minimal invasive direct coronary artery bypass (MIDCAB), and twenty-three patients had a totally endoscopic coronary artery bypass (TECAB) grafting. Nine patients (16%) were converted to open techniques. The mean total operating time for TECAB was 372 +/- 104 minutes and for MIDCAB was 220 +/- 69 minutes. Followup was complete for all patients up to one year. There was one hospital death following MIDCAB and two deaths at follow up. Forty-eight patients had an angiogram or CT scan revealing occlusion or anastomotic stenoses (>50%) in 6 patients. Overall permeability was 92%. Conclusions. Robotic surgery can be performed with promising results.

Robotic coronary artery bypass grafting.

Robotically assisted surgery enables coronary surgery to be performed totally or partially endoscopically. Using the Da Vinci robotic technology allows minimally invasive treatments. We report on our experience with coronary artery surgery in our department: patients requiring single or double vessel surgical revascularization were eligible. The procedure was performed without cardiopulmonary bypass on a beating heart. From April 2004 to May 2008, 55 consecutive patients were enrolled in the study, and were operated on by a single surgical team. Operative outcomes included operative time, estimated blood loss, transfusions, ventilation time, intensive care unit (ICU) and hospital length of stay. Average operative time was 270 ± 101 min with an estimated blood loss of 509 ± 328 ml, a postoperative ventilation time of 6 ± 12 h, ICU stay of 52 ± 23 h, and a hospital stay of 7 ± 3 days. Nine patients (16%) were converted to open techniques, and transfusion was required in four patients (7%). Follow-up was complete for all patients up to 1 year. There was one hospital death (1.7%) and two deaths at follow-up. Coronary anastomosis was controlled in 48 patients by either angiogram or computed tomography scan, revealing occlusion or anastomotic stenoses (>50%) in six patients. Overall permeability was 92%. Major adverse events occurred in 12 patients (21%). One-year survival was 96%. Our initial experience with robotically assisted coronary surgery is promising: it avoids sternotomy and with a methodical approach we were able to implement the procedure safely and effectively in our practice, combining minimal mortality with excellent survival.

Future of cardiac surgery: minimally invasive techniques in sutureless valve resection.

Aortic valve replacement with mechanical or biological heart valves is the treatment of choice for aortic valve stenosis when it is symptomatic or with severe aortic stenosis (< or = 0.6 cm(2)/m(2)) or with left ventricular dysfunction. In an effort to improve the outcomes of patients with stented biological valves, stentless valves were introduced to clinical practices in the early 1990s. Theses valves were designed to be less obstructive, and thus result in a lower transvalvular gradient. Technically the implantations of these valves are more demanding resulting in longer cross clamp and bypass times. However, important comorbid conditions in elderly patients referred for aortic valve replacement require alternative treatment options with possible reductions of the extracorporeal bypass time and reliable hemodynamic features. In order to comply with these requirements, percutaneous valves and sutureless surgical valves have been developed. The percutaneous technique has the advantage of being performed without circulatory bypass but leaving the aortic calcifications in place, thereby resulting in a high degree of paravalvular insufficiency, atrioventricular block and strokes. The surgical approach has the advantage of removing all calcifications and the valves can be optimally implanted, resulting in minimal paravalvular leak with a low incidence of atrioventricular block and strokes; however, it requires cardiopulmonary bypass. In addition, it can be performed with a low mortality (<3% in isolated aortic replacement, even in older patients). This article reviews the various techniques, strength and limitations of these sutureless valves implanted in the aortic position.

Sutureless Perceval S aortic valve replacement: a multicenter, prospective pilot trial.

BACKGROUND AND AIM OF THE STUDY: A European, multicenter, prospective, non-randomized, clinical pilot trial was designed to evaluate the feasibility of the Perceval S sutureless aortic valve prosthesis. A clinical and echocardiographic follow up was performed at the time of hospital discharge and subsequently after one, three, six, and 12 months. METHODS: The valve was implanted following sternotomy, extracorporeal circulation (ECC), aortic cross-clamping, cardioplegic arrest, and removal of the native valve. Implantation suturing was not required. Optimal annular sealing was obtained with brief low-pressure balloon dilation. If coronary bypass was indicated, a distal anastomosis was performed first. Between April 2007 and February 2008, 30 patients (mean age: 81 +/- 4 years) underwent aortic valve replacement. The prevalence of pure aortic stenosis was 76.7%, and that of mixed lesion 23.3%. The mean logistic EuroSCORE was 13.18%, and the NYHA class was III and IV in 93.3% and 6.7% of patients, respectively. The implanted valve size was 21 and 23 mm in 37% and 63% of patients, respectively, and 14 (46.7%) underwent coronary artery bypass grafting (11 internal mammary artery, nine vein grafts). RESULTS: The mean aortic cross-clamp and ECC times were 34 +/- 15 min and 59 +/- 21 min, respectively. There was one in-hospital death (3.3%), and three deaths occurred within 12 months of follow up (one death was valve-related, and two deaths were independent of the valve implantation). A total of 28 patients was assessed at one month post-implantation, and 23 after 12 months. No migration or dislodgement of the valve had occurred, but there were two mild paravalvular leakages and two mild intravalvular insufficiencies. CONCLUSION: The preliminary results of the trial confirmed the safety and efficacy of the Perceval S sutureless aortic valve. In this high-risk subset of patients, shortening the aortic cross-clamp and ECC times may help to reduce mortality and morbidity.

First-in-human feasibility and safety study of a true bifurcated stent for the treatment of bifurcation coronary artery lesions (DBS stent): six month angiographic results and five year clinical follow-up.

AIMS: To evaluate the safety and long-term efficacy of a true dedicated bifurcation bare metal stent (DBS) for the treatment of bifurcation coronary artery lesions. METHODS AND RESULTS: Thirty-four patients were enrolled in this prospective multicentre study. The majority of culprit lesions were located on the left anterior descending artery/diagonal bifurcation (n=19) followed by the distal protected left main (n=7), the left circumflex artery/obtuse marginal (n=4) and the distal right coronary artery/posterior descending artery (n=4). Successful delivery of the DBS stent at the bifurcation site was achieved in 32 patients (94%). Angiographic follow-up at six months was complete in 29 patients (91%). Clinical follow-up was achieved at five years in all DBS patients. There were no cardiac deaths or stent thrombosis. At six months, the MACE rate was 6/32 (19%) and the total binary restenosis rate was 10/29 (34%). MACE at 5 years consisted only in target vessel revascularisation and occurred in eight patients (25%). CONCLUSIONS: The DBS bare metal true bifurcated stent can be delivered successfully and safely in selected bifurcated lesions and has demonstrated long-term efficacy in most patients.

Comparison of transradial vs. transfemoral approach in the treatment of acute myocardial infarction with primary angioplasty and abciximab.

Compared to the femoral approach, the use of radial arterial access has been demonstrated to reduce the incidence of access site bleeding complications in staged procedures. The purpose of this study was to evaluate clinical outcomes comparing radial and femoral approaches in the treatment of acute myocardial infarction with primary angioplasty and the GP IIb/IIIa inhibitor abciximab. Between 15 September 1999 and 15 September 2002, we prospectively enrolled 119 consecutive patients undergoing primary angioplasty with abciximab comparing radial (n = 64) and femoral (n = 55) access. In this nonrandomized study, freedom from major cardiac events at 1-month follow-up occurred in 62 (97%) and 52 (94.5%) patients in the radial and the femoral groups, respectively (P = 0.19). There were no major access site bleeding complications in the radial group, as opposed to three (5.5%) in the femoral group (P = 0.03), all requiring transfusions, with surgical repair necessary in two. Uncomplicated clinical course occurred in 62 (97%) of patients in the radial group and 49 (89%) in the femoral group (P = 0.04). Total hospital length of stay was significantly higher in the femoral group (5.9 +/- 2.1 vs. 4.5 +/- 1.2 days; P = 0.05). Cannulation time (from patient arrival at the catheterization laboratory to the effective placement of arterial sheath) and procedural time were not significantly different in the radial and the femoral group (respectively 8.5 +/- 5.2 vs. 9.0 +/- 5.8 min, P = 0.81, and 42 +/- 28 vs. 44 +/- 27 min, P = 0.74). Nevertheless, time of radiation (23.1 +/- 11 vs. 16.5 +/- 10.9 min; P = 0.01) and dose-area product (28,616 +/- 16,571 vs. 18,819 +/- 10,739 R. cm2; P = 0.01) were significantly higher in the radial group. In patients with acute myocardial infarction treated with primary angioplasty and abciximab, the transradial access is efficacious with fewer major access site complications than transfemoral access. Transradial approach produces a shorter length of stay, as compared to the transfemoral approach, although with longer times of radiation and higher dose-area product.

Carbon-coated stents implanted in porcine iliac and renal arteries: histologic and histomorphometric study.

PURPOSE: To test in a pig model the biocompatibility and effectiveness of carbon-coated renal and iliac artery stent systems during implantation procedures and at different follow-up periods. MATERIALS AND METHODS: Twenty-two miniature pigs received carbon-coated balloon-expandable stainless-steel stents in their renal and iliac arteries. Animals were killed at 7, 30, or 180 days for evaluation of acute, subacute, and chronic biologic response to the implanted devices. Histologic, histomorphometric, and scanning electron microscopy (SEM) analyses were performed to assess inflammatory reaction, endothelialization process, and neointimal growth. RESULTS: Forty-four iliac stents and 42 renal stents were successfully implanted. Mural thrombi were not observed by angiography or histologic examinations. Histologically, no significant inflammatory reaction was detected: the stents appeared covered by a thin monolayer of endothelial cells even at 7-day follow-up. The neointima showed homogeneous growth and moderate thickness at 30-day and 180-day explantations (0.09 mm +/- 0.06 and 0.15 mm +/- 0.13, respectively, for renal arteries; 0.12 mm +/- 0.04 and 0.21 mm +/- 0.12, respectively, for iliac arteries). Internal and external elastic laminae were intact in 82 of 86 cases (95%) of stent-implanted arteries. Histologic validations were obtained with SEM observations for each follow-up group. CONCLUSIONS: This study showed good technical results of deployment of carbon-coated renal and iliac stents and very satisfactory biologic behavior in terms of tissue and hematologic compatibility. The devices do not induce thrombus formation.

Aortic pulse pressure and extent of coronary artery disease in percutaneous transluminal coronary angioplasty candidates.

BACKGROUND: Pulse pressure and aortic stiffness are both predictors of coronary artery disease. Whether these parameters are directly related to coronary structural alterations has never been studied. METHODS: From September 1999 to September 2000, the following data were collected from 99 eligible patients: invasive intra-aortic systolic and diastolic blood pressures (BP), extent of coronary artery disease, cardiovascular risk factors, and the incidence of angiographically documented restenosis after coronary angioplasty. RESULTS: In the study population, independent determinants of aortic pulse pressure were age, gender, aortic mean BP, heart rate, and extent of coronary artery disease (r2 = 0.57, P < .0001). In univariate analysis, invasive aortic, but not noninvasive brachial, mean pressure (P = .017) and pulse pressure (P = .027) were significantly associated to the extent of coronary artery disease. In a multiple regression analysis, only male gender (P = .013) and the level of aortic pulse pressure (P = .023) were independently associated with the extent of coronary heart disease. Restenosis was angiographically documented in 11 patients (11%). There was a borderline significant association of restenosis to aortic mean BP (P = .05) and to a past history of multiple previous angioplasties (P = .03). CONCLUSIONS: In this study, aortic pulse pressure was a significant risk factor for the extent of coronary artery disease. There was only a borderline significant association of restenosis to the steady, but not pulsatile, component of aortic BP in the stent era.