A. F. M. van den Heuvel

Closure of the femoral artery after cardiac catheterization: A comparison of Angio-Seal, StarClose, and manual compression

Objectives: To compare Angio‐Seal (AS) and StarClose (SC) and manual compression (MC) on efficacy of hemostasis, complication rate, safety of early mobilization, and patient comfort. Background: Closure of the femoral artery after cardiac catheterization can be obtained through different methods. Today, physicians can choose from a number of different devices to achieve arterial closure. Methods: In a prospective trial 450 patients were randomized to AS, SC, or MC. Patients were mobilized 1 to 2 hr after device placement, and 6 hr after MC. Data were collected during hospital admission and by telephone at one month after hospital discharge. Results: Devices were used in 138/150 allocated to AS and 124/150 allocated to SC patients (92% vs. 83%, P = 0.015) Patients with MC experienced more pain during sheath removal than patients receiving a device, and rated their period of bed rest as less comfortable. Oozing and need for pressure bandage at the puncture site were observed in 37 AS patients and 57 SC patients (25% vs. 38%, P = 0.002). Hematoma occurred in 15 AS patients, in 17 SC patients, and in 14 MC patients (11 vs. 14 vs. 9%, ns). Conclusion: There is no difference in safety between the three methods of arterial closure. SC was more often not used or successfully deployed. SC patients more often had continuing oozing. On patient comfort, closure devices performed better than MC. Early ambulation in patients with a closure device is safe. AS is the preferred method of arterial closure after cardiac catheterization.

Haemodynamic patterns in ST-elevation myocardial infarction: incidence and correlates of elevated filling pressures

Objectives. We sought to study the incidence and clinical correlates of elevated filling pressures in ST-elevation myocardial infarction (STEMI) patients, without physical signs of heart failure and treated with primary coronary angioplasty.Background. Haemodynamic data, as measured with a Swan-Ganz catheter, are not routinely obtained in STEMI patients. At admission, low blood pressure, increased heart rate, sweating, increased respiration rate, rales, oedema, and a third heart sound are indicative of heart failure.Methods. All consecutive STEMI patients were monitored by a Swan-Ganz catheter and central venous pressure (CVP), pulmonary capillary wedge pressure (PCWP), pulmonary artery pressure (PAS) and cardiac index (CI) were measured. To investigate the clinical correlates of the haemodynamic status patients were classified according to previously defined haemodynamic criteria.Results. We studied 90 patients, aged 60.5±13.1 year, 76% were male. Mortality at 30 days was 2/90 (2.2%). Patients with impaired haemodynamics presented later and had larger myocardial infarct sizes. CVP, PCWP and PAS were above normal in 36 (40%) patients.Conclusion. A large proportion of STEMI patients without physical signs of heart failure have elevation of right- as well as left-sided cardiac filling pressures. (Neth Heart J 2007:15:95-9.)

TAVI in heart failure, how much risk is acceptable?

Transcatheter valve implantations like TAVI and MitraClip implantations are becoming more important treatment options in patients with heart failure who cannot undergo an operation or for whom the operations risk for conventional surgical therapies is considered too high. The PARTNER trial provided evidence that transcatheter aortic valve implantations (TAVI) give a significant survival benefit in patients who are not surgical candidates and give comparable results in patients with high operative risk, compared with surgical aortic valve replacement (SAVR). In recent years the number of TAVI procedures has increased at a high rate. At the moment over 50,000 TAVI procedures have been performed. Due to the success of TAVI, there tends to be a shift towards performing TAVI in lower-risk categories, despite the fact that there is a complete lack of evidence about these groups. Although TAVI gives a significant survival benefit in the previously-described groups, the mortality rates at 1 year are still high. – 4 It is therefore important carefully to select patients who will benefit from the procedure, and even more important to identify those patients who will not benefit from TAVI.

A randomized controlled trial comparing StarClose and AngioSeal vascular closure devices in a district general hospital.

A randomized controlled trial comparing StarClose and AngioSeal vascular closure devices in a district general hospital.

Life-threatening bilateral aorto-ostial coronary artery disease in an octogenarian

Aorto-ostial disease is difficult to approach percutaneously; therefore, a surgical option may be more desirable. We describe a case of an octogenarian in which the clinical arguments and technical approach have been summarised for a successful percutaneous therapeutic strategy. (Neth Heart J 2009;17:30-2.)

Rebuttal: Closure of the Femoral Artery After Cardiac Catheterization: Comparing Angio-Seal, StarClose and Manual Compression

We appreciate the effort made by Mehta and Frutkin to review our article about comparing three ways of obtaining closure of the femoral artery after cardiac catheterization [1]. According to the authors, incidence of hematoma in our study is higher than in the ACUITY study [2]. However, our population consisted of elective patients admitted to the short-stay department, whereas in the ACUITY study patients with acute coronary syndromes were analyzed. Our patients were mobilized at a shorter time interval after cardiac catheterization, possibly resulting in a higher incidence of hematoma. Also concomitant antiplatelet medication differs between the two studies. We would like to stress that in none of our patients, the development of hematoma led to prolonged hospital admission period or surgical intervention. Mehta and Frutkin are correct in their estimation of 638 patients per group to achieve sufficient power, based on 9% versus 14% complication rate. With a study size of 150 patients per group, indeed our study was insufficiently powered for evaluating differences in complication rates in a superiority setting. However, the primary objective was success of hemostasis, the reason for the application of arterial closure, and this showed a statistically significant difference with SC as inferior to AS and MC. When considering AS noninferior to MC with regard to success of hemostasis, an evaluation of the rate of complications in a noninferiority setting will be of more interest. However, such a study will require an even larger study size, of course depending on the level of acceptance of noninferiority. Moreover, the reviewers report a high incidence of oozing and state that this cannot be readily dismissed. We indeed agree that the high incidence of oozing in specifically the StarClose group was one of the reasons to choose for Angio-Seal as preferred closure device at our short-stay department. As with hematoma, oozing was no reason for prolonged hospital stay. After evaluating the comments from Mehta and Frutkin, we still believe that our study implicates that Angio-Seal is the preferred method of hemostasis over StarClose and manual compression in the setting of our short-stay department. We gratefully acknowledge the statistical support received from Nic Veeger, clinical epidemiologist, Research Coordination Centre, University Medical Centre Groningen.