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BACKGROUND: Anecdotal evidence suggests that transcatheter aortic valve implantation (TAVI) is being used beyond pre-market label indications. METHODS: To assess the frequency and outcomes associated with 'off-label' use of TAVI, we conducted a retrospective study, examining adherence to patient selection criteria in 63 patients undergoing implantation with the 18F CoreValve ReValving System (CRS). Label status (on-label vs off-label) was determined by following (1) inclusion/exclusion criteria indicated in the 18F CRS safety and efficacy trial and (2) a patient selection matrix indicating anatomical boundaries to guide patient selection. Off-label use was defined as the presence of at least one exclusion criterion or 'non-acceptable' criteria based on the patient selection matrix. RESULTS: Off-label implantation was identified in 42 patients (67%)-40% had one, 19% had two and 8% had three or more off-label criteria. Baseline demographics were similar between the groups except for a higher logistic EuroSCORE in the on-label group (19.8 (11.2) vs 14.5 (7.3), p = 0.029). There was no significant difference in the procedural success rates between the on-label and off-label groups (91% vs 95%, respectively, p = 0.47). The frequency of angiographic moderate-severe aortic regurgitation, post-implant dilatation or implantation of a second valve was also similar between the groups. At 30 days, the cumulative death rate was 10%; there were four deaths in the 'on-label' and three deaths in the 'off-label' group. CONCLUSION: In this study we found that 'off-label' implantation of the CRS was common. Further studies are needed to evaluate the consequences of 'label status' for patients undergoing TAVI. [ABSTRACT FROM AUTHOR]

Background: Anecdotal evidence suggests that transcatheter aortic valve implantation (TAVI) is being used beyond pre-market label indications. Methods: To assess the frequency and outcomes associated with "off-label" use of TAVI, we conducted a retrospective study, examining adherence to patient selection criteria in 63 patients undergoing implantation with the 18F CoreValve ReValving System (CRS). Label status (on-label vs off-label) was determined by following (1) inclusion/exclusion criteria indicated in the 18F CRS safety and efficacy trial and (2) a patient selection matrix indicating anatomical boundaries to guide patient selection. Off-label use was defined as the presence of at least one exclusion criterion or "non-acceptable" criteria based on the patient selection matrix. Results: Off-label implantation was identified in 42 patients (67%)-40% had one, 19% had two and 8% had three or more off-label criteria. Baseline demographics were similar between the groups except for a higher logistic EuroSCORE in the on-label group (19.8 (11.2) vs 14.5 (7.3), p=0.029). There was no significant difference in the procedural success rates between the on-label and off-label groups (91% vs 95%, respectively, p=0.47). The frequency of angiographic moderate-severe aortic regurgitation, post-implant dilatation or implantation of a second valve was also similar between the groups. At 30 days, the cumulative death rate was 10%; there were four deaths in the "on-label" and three deaths in the "off-label" group. Conclusion: In this study we found that "off-label" implantation of the CRS was common. Further studies are needed to evaluate the consequences of "label status" for patients undergoing TAVI. [ABSTRACT FROM AUTHOR]

Objective: To assess the potential relation between plaque composition and vascular remodelling by using spectral analysis of intravascular ultrasound (IVUS) radiofrequency data. Methods and Results: 41 coronary vessels with non-significant (< 50% diameter stenosis by angiography), < or = 20 mm, non-ostial lesions located in non-culprit vessels underwent IVUS interrogation. IVUS radiofrequency data obtained with a 30 MHz catheter, were analysed with IVUS virtual histology software. A remodelling index (RI) was calculated and divided into three groups. Lesions with RI > or = 1.05 were considered to have positive remodelling and lesions with RI < or = 0.95 were considered to have negative remodelling. Lesions with RI > or = 1.05 had a significantly larger lipid core than lesions with RI 0.96-1.04 and RI < or = 0.95 (22.1 (6.3) v 15.1 (7.6) v 6.6 (6.9), p < 0.0001). A positive correlation between lipid core and RI (r = 0.83, p < 0.0001) and an inverse correlation between fibrous tissue and RI (r = -0.45, p = 0.003) were also significant. All of the positively remodelled lesions were thin cap fibroatheroma or fibroatheromatous lesions, whereas negatively remodelled lesions had a more stable phenotype, with 64% having pathological intimal thickening, 29% being fibrocalcific lesions, and only 7% fibroatheromatous lesions (p < 0.0001). Conclusions: In this study, in vivo plaque composition and morphology assessed by spectral analysis of IVUS radiofrequency data were related to coronary artery remodelling. [ABSTRACT FROM AUTHOR]

Objective: To compare clinical outcome of paclitaxel eluting stents (PES) versus sirolimus eluting stents (SES) for the treatment of acute ST elevation myocardial infarction. Design and patients: The first 136 consecutive patients treated exclusively with PES in the selling of primary percutaneous coronary intervention for acute myocardial infarction in this single centre registry were prospectively clinically assessed at 30 days and one year. They were compared with 186 consecutive patients treated exclusively with SES in the preceding period. Setting: Academic tertiary referral centre. Results: At 30 days, the rate of all cause mortality and reinfarction was similar between groups (6.5% v 6.6% for SES and PES, respectively, p = 1.0). A significant difference in target vessel revascularisation (TVR) was seen in favour of SES (1.1% v 5.1% for PES, p = 0.04). This was driven by stent thrombosis (n = 4), especially in the bifurcation stenting (n = 2). At one year, no significant differences were seen between groups, with no late thrombosis and 1.5% in-stent restenosis (needing TVR) in PES versus no reinterventions in SES (p = 0.2). One year survival free of major adverse cardiac events (MACE) was 90.2% for SES and 85% for PES (p = 0.16). Conclusions: No significant differences were seen in MACE-free survival at one year between SES and PES for the treatment of acute myocardial infarction with very low rates of reintervention for restenosis. Bifurcation stenting in acute myocardial infarction should, if possible, be avoided because of the increased risk of stent thrombosis. [ABSTRACT FROM AUTHOR]

Objective: To describe the association between cognitive outcome in the first postoperative week and that at three months after both off-pump and on-pump coronary bypass surgery, and to make a direct comparison of early cognitive outcome after off-pump versus on-pump surgery. Design: Randomised trial with an additional prediction study within the two randomised groups. Setting: Three centres for heart surgery in the Netherlands. Patients: 281 patients, mean age 61 years. Interventions: Participants were randomly assigned to off-pump or on-pump coronary bypass surgery. Main outcome measures: Cognitive outcome, assessed by psychologists who administered neuropsychological tests one day before and four days and three months after surgery. A logistic regression model was used to study the predictive association between early cognitive outcome, together with eight clinical variables, and cognitive outcome after three months. Results: Cognitive outcome in the first week after surgery was determined for 219 patients and was a predictor of cognitive decline after three months. This association was stronger in on-pump patients (odds ratio (OR) 5.24, p < 0.01) than in off-pump patients (OR 1 .80, p = 0.23). Early decline was present in 54 patients (49%) after off-pump surgery and 61 patients (57%) after on-pump surgery (OR 0.73, p = 0.25). Conclusions: In patients undergoing first time coronary bypass surgery, early cognitive decline predicts cognitive outcome after three months. Early cognitive decline is not significantly influenced by the use of cardiopulmonary bypass. [ABSTRACT FROM AUTHOR]

OBJECTIVE--To study the immediate and long-term clinical success of percutaneous transluminal coronary angioplasty in patients aged 35 years or less. DESIGN--Patients undergoing percutaneous transluminal angioplasty were prospectively entered into a dedicated database. Clinical and angiographic data on all patients aged 35 years or less were reviewed. Follow up data were collected by interview during outpatient visits, by questionnaire, or from referring physicians. SETTING--A tertiary referral cardiac centre. PATIENTS--57 patients aged 35 years or less (median 33, range 22-35) underwent coronary angioplasty because of unstable angina (32 patients), stable angina (23 patients), acute myocardial infarction (1 patient), and documented ischaemia in a cardiac transplant patient. RESULTS--The primary clinical success rate (reduction in diameter stenosis to < 50% without in-hospital events) was 88%. A major procedure related complication occurred in 5 patients (9%): one patient died, two patients sustained an acute myocardial infarction, two patients underwent emergency bypass surgery, and in three patients repeat angioplasty was performed before hospital discharge. In 2 patients (4%) coronary angioplasty did not significantly reduce the diameter stenosis but there were no associated complications. A total of 60 lesions were attempted (balloon angioplasty in 57, directional atherectomy in 2). The initial angiographic success rate was 92%. The median (SD) follow up was 4.7 (3.0) years. During follow up 7 patients (12%) died, 10 sustained a myocardial infarction (18%), and 28 patients (49%) underwent repeat revascularisation (coronary artery bypass grafting in 7 (12%) and repeat angioplasty in 21 (37%)). The estimated 5 year survival and event-free survival (Kaplan-Meier method) was 87 (9)% and 50 (13)%, respectively. Multivariate logistic regression analysis showed that hypertension and the extent of vessel disease were the only independent predictive factors for event free survival. CONCLUSIONS--In young patients coronary angioplasty had a high immediate success rate but many needed repeat revascularisation procedures during the follow up period and survival was not improved. Coronary angioplasty in young patients should be regarded as a palliative procedure. [ABSTRACT FROM PUBLISHER]

OBJECTIVE--To study the immediate and long term clinical success of percutaneous transluminal coronary balloon angioplasty in patients over 70 years old. DESIGN--Patients undergoing percutaneous transluminal angioplasty were prospectively entered in a specially designed database. The clinical and angiographic data of all patients over 70 were reviewed. Follow up data were collected by interview, during outpatient visits, by questionnaire, or through the referring physician. SETTING--A tertiary referral cardiac centre. PATIENTS--166 patients over 70 (median 73, range 70-84) underwent coronary angioplasty because of unstable angina (81 patients), stable angina (76 patients), or acute myocardial infarction (nine patients). RESULTS--The initial clinical success rate was 86% (142 of 166 patients). A major procedural complication occurred in 10 patients (6%): four patients (2%) died, six patients (4%) underwent emergency bypass surgery, and five patients (3%) sustained an acute myocardial infarction. In 14 patients (8%) coronary angioplasty did not significantly reduce the diameter stenosis but there were no associated complications. A total of 226 lesions were attempted. The initial angiographic success rate was 192 out of 226 lesions (85%). The median follow up was 21 (range 0.5-66) months. Sixteen patients (10%) died during follow up, eight patients (5%) sustained a non-fatal myocardial infarction, 21 patients (13%) underwent a second or third balloon dilatation, and 17 patients (10%) underwent elective bypass surgery. Of the 146 survivors, 99 patients (68%) had sustained clinical improvement. The estimated survival at four years (Kaplan-Meier method) was 89 (SD 4)%. The event free survival at four years for the total study population was 61 (8)%. Multivariate logistic regression analysis showed that the extent of vessel disease was the only independent predictive factor for event free survival: the event free survival rate was 81 (10)% at four years for patients with single vessel disease, compared with 45 (12)% for patients with multivessel disease. CONCLUSIONS--Coronary angioplasty in patients over 70 was a safe and effective treatment for obstructive coronary artery disease. The extent of vessel disease, and not the completeness of revascularisation, was the only independent predictive factor for event free survival. [ABSTRACT FROM PUBLISHER]

Thirty three consecutive patients with clinically suspected endocarditis were studied by both precordial cross sectional echocardiography and transoesophageal echocardiography. The diagnostic value of both techniques was assessed. The data were compared with findings at operation in 25 patients. In 21 patients with native valve endocarditis precordial echocardiography showed evidence of vegetations in six patients and suggested their presence in nine. Transoesophageal echocardiography identified vegetations in 18 patients. Complications were seen in four patients at precordial echocardiography and in nine patients at transoesophageal echocardiography. Precordial echocardiography did not show vegetations in any of the 12 patients with prosthetic valve endocarditis whereas transoesophageal echocardiography showed vegetations in four. Complications were seen in four patients at precordial echocardiography and in 10 at transoesophageal echocardiography. Echocardiographic findings were confirmed at operation in all 25 operated patients. In two patients both echocardiographic techniques had missed the perforation of the cusps of the aortic valve that was seen at operation, but this had no effect on patient management. Transoesophageal echocardiography is the best diagnostic approach when infective endocarditis is suspected in patients with either native or prosthetic valves. [ABSTRACT FROM PUBLISHER]

OBJECTIVE To describe the long term clinical outcome (up to 11 years) after coronary stenting. DESIGN A single centre observational study encompassing 1000 consecutive patients with a first stent implantation (1560 stents) between 1986 and 1996, who were followed for at least one year with a median follow up of 29 months (range 12–132 months). RESULTS Up to July 1997 the cumulative incidence of the major adverse cardiac events (MACE) of death, non-fatal acute myocardial infarction, coronary artery bypass grafting, and repeat percutaneous transluminal coronary angioplasty was 8.2%, 12.8%, 13.1%, and 22.4%, respectively. Survival at one, three, and five years was 95%, 91%, and 86%, respectively. Comparison of MACE incidence during the “anticoagulant era” and the “ticlopidine era” revealed significantly improved event free survival with ticlopidine (27% 13%; p < 0.005). Multivariable analyses showed that ejection fraction < 50% (relative risk (RR) 4.1), multivessel disease (RR 3.0), diabetes (RR 2.9), implantation in saphenous vein graft (RR 2.1), indication for unstable angina (RR 1.9), and female sex (RR 1.7) were independent predictors of increased mortality after stenting. Independent predictors of any MACE were multivessel stenting (RR 2.0), implantation in saphenous bypass graft (RR 1.6), diabetes (RR 1.5), anticoagulant treatment (versus ticlopidine and aspirin) (RR 1.5), bailout stenting (RR 1.5), multivessel disease (RR 1.4), and multiple stent implantation (RR 1.5). CONCLUSIONS Long term survival and infarct free survival was good, particularly in non-diabetic men with single vessel disease and good ventricular function, who had a single stent implanted in a native coronary artery. A dramatic improvement was observed in event free survival, both early and late, with the replacement of anticoagulation by ticlopidine. This, of course, cannot be separated from improved stent implantation techniques between 1986 and 1995. Ultimately, almost 40% of the patients experienced an adverse cardiac event (mainly repeat intervention) in the long term. New advances in restenosis treatments and in secondary prevention must be directed at this aspect of patient management after stenting. [ABSTRACT FROM PUBLISHER]