Percutaneous Atrial Septal Defect Closure Using the Occlutech Figulla Device in Adults: More than 800 Patient-Years of Follow-Up.

PURPOSE: The Occlutech Figulla occluder has been proven safe and effective at midterm follow-up after percutaneous atrial septal defect (ASD) closure. We describe the safety and efficacy at long-term follow-up in adults. METHODS: All consecutive adult patients that underwent ASD closure between 2008 and 2015 were included. All complications were registered. Residual left-to-right shunt (LRS) was diagnosed using color-Doppler transthoracic echocardiography (TTE). Right-to-left shunting was diagnosed using contrast TTE. Successful closure was defined as no LRS at follow-up. RESULTS: In total, 166 patients (mean age 56.7 ± 16.1 years; 62% female) underwent percutaneous ASD closure using the Occlutech Flex I (70%) or Flex II (30%) device (diameter 24 mm; range 10-40 mm) under general anaesthesia and transoesophageal echocardiographic guidance. Long-term follow-up data were available for 144 patients (87%) with a mean follow-up of 5.9 ± 2.6 years, a total of 814 patient-years. During hospitalization, device embolization occurred in three patients (1.8%) with successful extraction in all. During the long-term follow-up, 15 patients (9.8%) suffered new-onset atrial fibrillation and stroke occurred in 2.1%. There was no residual LRS at 12-month follow-up. No device embolization occurred during the long-term follow-up. CONCLUSION: Percutaneous ASD closure using the Occlutech device appears to be safe at long-term follow-up with a high successful closure rate at one year.

Five-year results of the complete versus culprit vessel percutaneous coronary intervention in multivessel disease using drug-eluting stents II (CORRECT II) study: a prospective, randomised controlled trial.

OBJECTIVES/BACKGROUND: In patients with multivessel coronary artery disease (MVD) the decision whether to treat a single culprit vessel or to perform multivessel revascularisation may be challenging. The purpose of this study was to evaluate the long-term outcome of multivessel percutaneous coronary intervention (MV-PCI) versus culprit vessel only (CV-PCI) in patients with stable coronary artery disease or non-ST elevation acute coronary syndrome. METHODS: In this dual-centre, prospective, randomised study a total 215 patients with MVD were randomly assigned to MV-PCI or CV-PCI. The primary endpoint was the occurrence of major adverse cardiac events (MACE) including death, myocardial infarction (MI), and repeat revascularisation. Secondary endpoints were the combined endpoint of death or MI, the individual components of the primary endpoint, and the occurrence of stent thrombosis. Patients were followed up to 5 years after enrolment. RESULTS: The occurrence of the primary endpoint was similar at 28% versus 31% in the MV-PCI and CV-PCI group, respectively (hazard ratio [HR] 0.87, 95% confidence interval [CI]: 0.53-1.44, p = 0.59). The rate of repeat revascularisation was 15% versus 24% (HR 0.59, 95% CI 0.32 to 1.11, p = 0.11), whereas definite or probable stent thrombosis occurred in 2% versus 0% (p = 0.44). CONCLUSIONS: In this randomised study comparing the strategies for MV-PCI and CV-PCI in patients with MVD, no difference was found in the occurrence of MACE after 5 years. We observed a numerically higher rate of death or MI and a lower rate of repeat revascularisation after MV-PCI, although these findings were not statistically significant.

Veno-arterial extracorporeal membrane oxygenation in addition to primary PCI in patients presenting with ST-elevation myocardial infarction.

INTRODUCTION: Primary percutaneous coronary intervention (pPCI) in ST-elevation myocardial infarction (STEMI) can cause great haemodynamic instability. Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) can provide haemodynamic support in patients with STEMI but data on outcome and complications are scarce. METHODS: An in-hospital registry was conducted enrolling all patients receiving VA-ECMO. Patients were analysed for medical history, mortality, neurological outcome, complications and coronary artery disease. RESULTS: Between 2011 and 2016, 12 patients underwent pPCI for STEMI and received VA-ECMO for haemodynamic support. The majority of the patients were male (10/12) with a median age of 63 (47-75) years and 4 of the 12 patients had a history of coronary artery disease. A cardiac arrest was witnessed in 11 patients. The left coronary artery was compromised in 8 patients and 4 had right coronary artery disease. All patients were in Killip class IV. Survival to discharge was 67% (8/12), 1­year survival was 42% (5/12), 2 patients have not yet reached the 1­year survival point but are still alive and 1 patient died within a year after discharge. All-cause mortality was 42% (5/12) of which mortality on ECMO was 33% (4/12). Patient-related complications occurred in 6 of the 12 patients: 1 patient suffered major neurological impairment, 2 patients suffered haemorrhage at the cannula site, 2 patients had limb ischaemia and 1 patient had a haemorrhage elsewhere. There were no VA-ECMO hardware malfunctions. CONCLUSION: VA-ECMO in pPCI for STEMI has a high survival rate and neurological outcome is good, even when the patient is admitted with a cardiac arrest.

Percutaneous closure of a patent foramen ovale after cryptogenic stroke.

A patent foramen ovale is a common intracardiac finding that is located between the left and right atrium. It can cause right-to-left shunting and has a high prevalence in patients who suffer a cryptogenic stroke. Earlier trials did not show superiority of percutaneous patent foramen ovale closure with standard medical therapy over standard medical therapy alone in the treatment of cryptogenic stroke. Interestingly, several meta-analyses show positive results regarding closure, suggesting underpowering of the individual trials. Recently, two large prospective trials and one long-term follow-up study showed benefit of percutaneous closure over standard medical therapy in treatment of cryptogenic stroke. A larger right-to-left shunt or the presence of an atrial septal aneurysm were predictors for a recurrent event. Therefore, percutaneous patent foramen ovale closure after cryptogenic stroke should be recommended over antiplatelet therapy alone in patients younger than 55 years of age with a high-risk patent foramen ovale.

Feasibility of multiplane microtransoesophageal echocardiographic guidance in structural heart disease transcatheter interventions in adults.

INTRODUCTION: Structural heart interventions are guided by transoesophageal or intracardiac echocardiography (TEE/ICE). MicroTEE, developed for paediatric purposes, is smaller and therefore less invasive and traumatic, avoiding the need for general anaesthesia. We aimed to show feasibility of procedural guidance by comparing image quality of microTEE with standard TEE and ICE during adult transcatheter interventions, and assess the accuracy in obtaining left atrial appendage (LAA) measurements between the microTEE probe and standard TEE. METHODS AND RESULTS: We prospectively included 49 patients (20 women, 64 ± 18 years). Intraprocedural images were obtained by using the microTEE probe and standard (2D and 3D) TEE (LAA closure, MitraClip implantation) or ICE (interatrial communication closure, transseptal puncture for left atrial ablation). Two echocardiographers independently assessed image quality from 1 (excellent) to 4 (poor) and performed LAA measurements. Use of microTEE was not related to significant discomfort. Image quality obtained with the microTEE probe was lower than with standard TEE (2 [1-2] vs. 1 [1-2]; p = 0.04) and comparable with ICE images (2 [1-2] vs. 2 [1-2], p = 0.13). MicroTEE showed a wider field of view than ICE. LAA measurements on images obtained by microTEE were strongly associated with standard TEE. CONCLUSIONS: MicroTEE seems feasible for guidance during transcatheter heart interventions in adults. MicroTEE imaging offers a wider field of view than ICE, and its accuracy is comparable with TEE. In transcatheter interventions performed under conscious sedation, microTEE might be a viable and advantageous alternative to standard TEE or ICE.

Impact of percutaneous coronary intervention timing on 5-year outcome in patients with non-ST-segment elevation acute coronary syndromes. The 'wait a day' approach might be safer.

BACKGROUND: The OPTIMA trial was a randomised multicentre trial exploring the influence of the timing of percutaneous coronary intervention (PCI) on patient outcomes in an intermediate to high risk non-ST-elevation acute coronary syndrome (NSTE-ACS) population. In order to decide the best treatment strategy for patients presenting with NSTE-ACS, long-term outcomes are essential. METHODS: Five-year follow-up data from 133 of the 142 patients could be retrieved (94 %). The primary endpoint was a composite of death and spontaneous myocardial infarction (MI). Spontaneous MI was defined as MI occurring more than 30 days after randomisation. Secondary endpoints were the individual outcomes of death, spontaneous MI or re-PCI. RESULTS: No significant difference with respect to the primary endpoint was observed (17.8 vs. 10.1 %; HR 1.55, 95 % CI: 0.73-4.22, p = 0.21). There was no significant difference in mortality rate. However, spontaneous MI was significantly more common in the group receiving immediate PCI (11.0 vs. 1.4 %; HR 4.46, 95 % CI: 1.21-16.50, p = 0.02). We did not find a significant difference between the groups with respect to re-PCI rate. CONCLUSION: There was no difference in the composite of death and spontaneous MI. The trial suggests an increased long-term risk of spontaneous MI for patients treated with immediate PCI.

TIDES-ACS Trial: comparison of titanium-nitride-oxide coated bio-active-stent to the drug (everolimus)-eluting stent in acute coronary syndrome. Study design and objectives.

Drug-eluting stents (DES), delivering antiproliferative drugs from a durable polymer, have shown to reduce in-stent restenosis after percutaneous coronary intervention (PCI) compared to bare-metal stents (BMS). However, they have been associated with a hypersensitivity reaction, delayed healing, and incomplete endothelialization, which may contribute to an increased risk of late stent thrombosis. Consequently, a prolonged duration of dual antiplatelet therapy (DAPT) is needed, with an increased risk of bleeding complication. A number of stent technologies are being developed in an attempt to modify late thrombotic events and DAPT duration. The Optimax™ stent is such a novel, next generation bioactive stent (BAS), in which a thicker layer of titanium-nitride-oxide coating is inserted over the stent struts. The rationale of this is to obtain more efficient and rapid vascular healing at the site of the stent implantation. The aim of TIDES-ACS Trial is to compare clinical outcome in patients presenting with ACS, treated with PCI using Optimax-BAS versus Synergy™-EES. Second objective is to explore whether the Optimax™-BAS use is superior compared with Synergy™-EES use with respect of hard end points (cardiac death, myocardial infarction [MI] and major bleeding). A prospective, randomized, multicenter trial (ClinicalTrials.gov Identifier: NCT02049229), will be conducted in interventional centres in Finland (six centres), France (five centres) and Holland (two centres), including a total of 1800 patients.

Ultra-thin strut cobalt chromium bare metal stent usage in a complex real-world setting. (SOLSTICE registry).

AIM: To report clinical follow-up at 6 months after implantation of the ultra-thin strut cobalt chromium SolarFlex stent in a real-world setting. METHODS AND RESULTS: Patients (n = 240) with single or multiple vessel coronary artery disease undergoing percutaneous coronary intervention (PCI) at four sites in Europe were enrolled in the SOLSTICE (SolarFlex Stent in Routine Clinical Practice) registry. Follow-up at 6 months was 100 %. Diabetes was present in 29 % of the patients, 30 % presented with acute myocardial infarction and 17 % had unstable angina. Of the patients, 27 % had previously undergone PCI or coronary artery bypass surgery. Lesion complexity was high (50 % B2 + C type lesions). Device success was achieved in 99.7 % of cases and the major adverse cardiac event (MACE) rate was 5.8 % at 6 months of follow-up. Target lesion revascularisation (TLR) was 5.0 % at 6 months. CONCLUSIONS: The SOLSTICE registry showed that in a complex real-world setting the SolarFlex bare metal stent, with ultra-thin struts and customised scaffolding, provided low clinical MACE and TLR rates. These results provide support for the use of the latest generation bare metal stent in contemporary European practice.

High versus standard clopidogrel loading in patients undergoing carotid artery stenting prior to cardiac surgery to assess the number of microemboli detected with transcranial Doppler: results of the randomized IMPACT trial.

AIM: The aim of this study was to compare the effects of 300 mg or 600 mg clopidogrel loading dose, prior to carotid artery stenting (CAS) on the number of transcranial Doppler (TCD)-detected microembolic signals (MES) and to investigate the relationship between the magnitude of platelet reactivity and MES. METHODS: In this prospective randomized, double-blind study, 35 consecutive asymptomatic patients (17.1% females), scheduled for CAS and cardiac surgery were included. The primary endpoint was the number of TCD-detected MES. The secondary endpoints were the absolute magnitude of on-treatment platelet reactivity and the adverse cerebral events. Negative binomial regression to find predictors for sum of single emboli, the student's t-test to assess the association between platelet function tests and randomized dose of 300 mg or 600 mg clopidogrel, and the R2 calculation for the assessment of the association between platelet function tests and embolic load, were used. RESULTS: No statistically significant difference in the number of TCD-detected MES, in the sum of all the single emboli or showers and platelet aggregation measurements between the two groups was observed (aggregometry: 21.7±18.3 versus 23±18%, P=0.8499 and 45.8±17.5 versus 46.5±14.5%, P=0.9003) (verifyNow P2Y12 assay: 231±93 PRU versus 222±86 PRU, P=0.7704). In one patient a transient ischemic attack occurred. CONCLUSION: A loading dose of 300 mg of clopidogrel in combination with aspirin is as effective as 600 mg of clopidogrel in achieving adequate platelet inhibition and preventing periprocedural events in asymptomatic patients undergoing CAS prior to cardiac surgery.

New bioabsorbable septal repair implant for percutaneous closure of a patent foramen ovale: short-term results of a single-centre experience.

BACKGROUND: Permanent implants for closure of a patent foramen ovale (PFO) have a number of possible disadvantages including erosions, thrombus formation, and allergic reactions. The incidence of adverse events may be lower using a bioabsorbable device. OBJECTIVE: To evaluate the short-term safety and efficacy of a new bioabsorbable closure device. METHODS: All 35 consecutive patients (21 female, mean age 47.9 +/- 10.8 years), who underwent a percutaneous PFO closure between November 2007 and July 2008, were included. All complications were reported. The efficacy was based on the residual shunting the day after implant and at 1 month follow-up and was graded as minimal, moderate, or severe, using contrast transthoracic echocardiography with the Valsalva manoeuvre. RESULTS: The only in-hospital complication was a surgical device retrieval from the femoral vein. Four patients developed a minimal inguinal haematoma. One day after closure, residual shunting was present in 56% of the patients (minimal 27%, moderate 23% and severe 6%). At 1 month follow-up (n = 33), one patient developed a transient neurological deficit and three patients suffered from paroxysmal atrial fibrillation. A residual shunt at 1 month was present in 45% of the patients (minimal 30%, moderate 12%, and severe 3%). CONCLUSIONS: Percutaneous PFO closure using the bioabsorbable closure device seems to be safe. However, a high rate of residual shunting is present at 1 month follow-up. Long-term follow-up data are necessary to evaluate the efficacy and safety of this device.

Long-term outcome after balloon angioplasty of coarctation of the aorta in adolescents and adults: Is aneurysm formation an issue?

OBJECTIVES: The purpose was to evaluate long-term outcome following balloon angioplasty for coarctation in adults. BACKGROUND: Long-term results of balloon angioplasty for native coarctation in adults remain incomplete, especially concerning the occurrence of aneurysm formation. METHODS: Long-term follow-up data were collected in consecutive patients retrospectively. Results of balloon angioplasty (29 patients, age 15-71 years, during 1995-2005) for discrete, native coarctation were evaluated, including MRI or CT. RESULTS: Mean follow-up ranged from 2.2 to 13 years (mean 8.5 +/- 3.2). Immediate success was obtained in all patients. Early mortality or complications were not encountered. Peak systolic pressure gradient decreased from 52 +/- 21 to 7.2 +/- 7.6 mm Hg (P < 0.001). Intima tear was detected in eight procedures angiographically, without signs of dissection. Three-month follow-up angiography in these patients showed unchanged (4/8 patients) or diminished abnormalities (4/8 patients). One asymptomatic patient, known with left ventricular dysfunction due to significant aortic valve insufficiency, died suddenly 5 years after balloon angioplasty. Recoarctation occurred in one patient (3%). Late aneurysm formation was excluded by MR in 24/29 and CT in remaining 5/29 patients during follow-up, including those patients in whom intima tear was encountered immediately postangioplasty. In three of seven patients an irregular aortic contour persisted, without indication of progression or aneurysm formation. Hypertension was completely relieved in 67% (14/21 patients) and improved in 33% (7/21 patients). CONCLUSIONS: Balloon angioplasty for native coarctation yields low reintervention probability in adult patients. Despite occurrence of angiographically established intimal tearing, aortic dissection and aneurysm formation were not encountered.

Revascularization strategy in patients with severe concurrent severe carotid and coronary artery disease: ''failure to move forward is reason to regress''.

In the absence of randomized trials, the optimal management of patients with concomitant carotid and coronary artery disease remains disputable. The initial studies of combined or staged carotid endarterectomy in these patients were conceived in an attempt to reduce perioperative mortality. Although encouraging results have been reported with combined carotid endarterectomy and cardiac surgery, this combination requires long operative times and remains a surgical challenge. Recent studies have shown that carotid angioplasty and stenting prior to cardiac surgery is a feasible and effective minimal invasive technique. However, the effect of carotid stenting on the incidence of death and stroke after cardiac surgery is indistinct. Carotid stenting followed by cardiac surgery may provide a valuable treatment for patients with combined carotid and cardiac disease. The high rate of freedom from death and stroke during follow-up supports the long-term durability of this strategy. In the present review, we highlight the available data on carotid stenting and cardiac surgery.

Immediate versus deferred coronary angioplasty in non-ST-segment elevation acute coronary syndromes.

BACKGROUND: The field of acute coronary syndromes is characterised by an increasing tendency towards early invasive catheter-based diagnostics and therapeutics-a practice based on observational and retrospective data. OBJECTIVE: To compare immediate versus deferred angioplasty in patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS) METHODS: A randomised, prospective multicentre trial was performed in patients admitted with NSTE-ACS, eligible for percutaneous coronary intervention (PCI). Interim analysis was performed after enrolment of 251 patients; PCI was appropriate in 142 patients. These patients were randomised to immediate PCI (n = 73) or deferred PCI (24-48 h) (n = 69). Patients received protocol-driven glycoprotein IIb/IIIa blockers, aspirin and clopidogrel. The primary end point was a composite of death, non-fatal myocardial infarction (MI) or unplanned revascularisation, at 30 days. After hospital discharge outpatient follow-up was performed at 30 days and 6 months. RESULTS: The incidence at 30 days of the primary end point was 60% in the group receiving immediate PCI and 39% in the group receiving deferred PCI (relative risk (RR) = 1.5, 95% CI 1.09 to 2.15; p = 0.004). No deaths occurred in either group. MI was significantly more common in the group receiving immediate PCI (60% vs 38%, RR = 1.6, 95% CI 1.12 to 2.28, p = 0.005). Unplanned revascularisation was similar in both groups. The observed difference was preserved over 6-months' follow-up. CONCLUSIONS: Immediate PCI was associated with an increased rate of MI in comparison with a 24-48 h deferred strategy, despite aggressive antithrombotic treatment. The results suggest that PCI for high-risk patients with non-refractory NSTE-ACS should be delayed for at least 24 h after hospital admission. TRIAL REGISTRATION NUMBER: ISRCTN80874637.

Complications and mid-term outcome after percutaneous patent foramen ovale closure in patients with cryptogenic stroke.

BACKGROUND: Percutaneous patent foramen ovale (PFO) closure seems to reduce the risk of recurrent thromboembolism. We report the safety and efficacy of percutaneous PFO closure in our centre. METHODS: All patients, >16 years of age, who underwent a percutaneous PFO closure in our centre were included. Reoccurrence of stroke, transient ischaemic attack (TIA) and peripheral thromboembolism were assessed. Periprocedural and midterm complications are reported. RESULTS: Eighty-three consecutive patients (mean age 49+/-13 years) were included. Indications for PFO closure were cryptogenic stroke (59.0%), TIA (33.7%), peripheral embolism (2.4%) and other (4.8%). For PFO closure, a Cardioseal/Starflex device was used in 63 patients and an Amplatzer PFO occluder device in 20 patients. Stroke recurred in 1.2%, TIA in 3.6%, peripheral embolism in 0% during a mean follow-up of 1.9+/-1.2 years. Major periprocedural complications occurred in 1.2%. The mid-term complication rate was 2.4% and only consisted of minor complications. During follow-up, a residual right-to-left shunt was present in 5.7% of the patients. No significant difference in outcome, complications or residual shunting could be documented between the two device types. CONCLUSION: In our centre, the percutaneous closure of a PFO seems to be a safe and effective procedure to prevent recurrence of paradoxical thrombo-embolic events. (Neth Heart J 2008;16:332-6.).

Will carotid angioplasty become the preferred alternative to staged or synchronous carotid endarterectomy in patients undergoing cardiac surgery?

In the absence of randomized trials, the optimal management of patients who present with concomitant carotid and coronary artery disease remains an enduring controversy, with much of the debate revolving around whether staged or synchronous carotid endarterectomy (CEA) will reduce peri-operative morbidity and mortality after cardiac surgery. Although encouraging results have been reported using either strategy, there remains no consensus as to which is preferable. More recently, however, carotid artery angioplasty with stenting (CAS) has emerged as a potential alternative to CEA. In 'high-risk for CEA' patients, CAS has shown comparable short and long-term outcome rates to CEA. Accordingly, CAS followed by cardiac surgery could offer a less invasive (and safer) therapeutic option in cardiac patients. This paper reviews the evidence to date supporting the use of CAS+CABG, while highlighting potential situations where such a strategy might be harmful. In particular, it will focus on how the need for dual antiplatelet therapy after CAS can be balanced with avoiding unnecessary bleeding complications after cardiac surgery.

Vascular occlusion as a late complication of the Angio-Seal closure device. A review of literature.

Although early vascular complications of the Angio-Seal closure device have been well described, little is known about late vascular complications due to this device. The aim of this paper is to discuss late femoral stenosis associated with the use of the Angio-Seal closure device. A literature search was performed using Medline', Embase' and The Cochrane Library' to identify relevant articles published up to the first of May 2007. Late occlusion was defined as an occlusion after approximately one week after Angio-Seal deployment. All together, eleven relevant papers were available. The reported prevalence of late vascular stenosis associated with Angio-Seal use varies between 1/961 and 4/175. Claudication was the most frequently reported complaint. In most cases, late stenosis due to the use of the Angio-Seal required surgery. Vascular obstruction due to the device has been reported up to 6 months after placement. In conclusion, vascular stenosis due to the use an Angio-Seal closure device is a complication that not only occurs in the first few days after placement, but also in the following months. In every patient developing complaints of arterial insufficiency after using an Angio-Seal, local arterial stenosis due to the device should be considered in the differential diagnosis. It therefore is important to register the use of the device in the patient chart.

The fate of the external carotid artery after carotid artery stenting. A follow-up study with duplex ultrasonography.

OBJECTIVE: To evaluate the long-term effect of carotid angioplasty and stenting (CAS) of the internal carotid artery (ICA) on the ipsilateral external carotid artery (ECA). SUBJECTS AND METHODS: We prospectively registered the pre- and post-interventional duplex scans obtained from 312 patients (mean age 70 years) who underwent CAS. Duplex scans were scheduled the day before CAS, 3 and 12 months post-procedurally and yearly thereafter, to study progression of obstructive disease in the ipsilateral ECA compared to the contralateral ECA. The duplex ultrasound criteria used to identify ECA stenosis >or=50% were Peak Systolic Velocities of >or=125 cm/s. RESULTS: Preprocedural evaluation of the ipsilateral ECA demonstrated >or=50% stenosis in 32.7% of cases vs 30% contralateral. Both ipsilateral and contralateral 3 (1%) ECA occlusions were noted. After stenting 5 (1.8%) occlusions were seen vs 1% contralateral. No additional ipsilateral occlusions and 2 additional contralateral occlusions were noted at extended follow-up. The prevalence of >or=50% stenosis of the ipsilateral ECA (Kaplan-Meier estimates) progressed from 49.1% at 3, to 56.4%, 64.7%, 78.2%, 72.3%, and 74% at 12, 24, 36, 48, and 60 months respectively. Contralateral prevalences were 31.3%, 37.7%, 41.7%, 43.1%, 46.0%, and 47.2% respectively (p<0.001). Progression of stenosis was more pronounced in 234 patients (75%) with overstenting of the carotid bifurcation (p=0.004). CONCLUSION: Our results show that significant progression of >or=50% stenosis in the ipsilateral ECA occurs after CAS. There was greater progression of disease in the ipsilateral compared with the contralateral ECA. Progression of disease in the ECA did not lead to the occurrence of occlusion during follow up.

Inhibition of platelet function by abciximab or high-dose tirofiban in patients with STEMI undergoing primary PCI: a randomised trial.

BACKGROUND: In patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI, few data exist on the magnitude of platelet activation, aggregation and dosing of glycoprotein (GP) IIb/IIIa receptor inhibitors. METHODS: Sixty STEMI patients were randomised to abciximab, to high-dose tirofiban or to no additional GP IIb/IIIa inhibitor treatment. Platelet activation (P-selectin expression) was measured using flow cytometry and the level of inhibition of platelet aggregation was assessed using the Plateletworks assay. Additionally, the PFA-100 with the collagen/adenosine-diphosphate cartridge (CADP) was used to compare the levels of platelet inhibition. All measurements were performed at baseline (T(0)), immediately after (T(1)), 30 minutes (T(2)), 60 minutes (T(3)) and 120 minutes (T(4)) after primary PCI. RESULTS: The level of platelet activation in both GP IIb/IIIa receptor inhibitor treated groups was significantly lower compared with the control group at all time points after primary PCI (p=0.04). Also the administration of the currently recommended dose of abciximab resulted in significantly lower levels of inhibition of aggregation compared with high-dose tirofiban (p<0.0001). In addition, the CADP closure times were significantly prolonged in both GP IIb/IIIa inhibitor treated groups compared with the control group at time points T(1) (p=0.006) and T(4) (p<0.0001). CONCLUSION: The administration of high-dose tirofiban resulted in a significantly higher inhibition of platelet aggregation compared with the currently recommended dose of abciximab. Large clinical trials are needed to assess whether this laboratory superiority of high-dose tirofiban translates into higher clinical efficacy. (Neth Heart J 2007;15:375-81.).

Dutch guidelines for interventional cardiology: institutional and operator competence and requirements for training.

Interventional cardiology is an expanding field within cardiovascular medicine and today it is generally accepted that cardiologists require specific training, knowledge and skills. Hospitals where coronary interventions are performed must be properly equipped and able to provide specialised care. Percutaneous coronary interventions are frequently used for coronary revascularisation. The public should have confidence in the uniformity of high quality care. Therefore, such quality of care should be maintained by certification of the individual operators, general guidelines for institutional requirements and formal audits. The Netherlands Society of Cardiology (NVVC) will be implementing a new registration system for cardiologists with a subspecialisation that will include registration for interventional cardiology. The NVVC asked the Working Group of Interventional Cardiology (WIC) to update the 1994 Dutch guidelines on operator and institutional competence, and requirements for training in interventional cardiology in order to incorporate them into the official directives. The present guidelines represent the expert opinion of the Dutch interventional cardiology community and are in accordance with international regulations. After two rounds of discussion, the NVVC approved the guidelines in November 2004 during the autumn meeting.