Rapid hemostasis of arterial puncture sites with collagen in patients undergoing diagnostic and interventional cardiac catheterization

Despite the continuous reduction of sheath sizes in diagnostic and interventional cardiac catheterizations and the discontinuation of coumadin use after coronary stent implantation, a challenging role remains for hemostatic devices in the sealing femoral puncture sites. Since the introduction of the vascular hemostatic device (VHD) in 1991 and the hemostatic puncture closing device (HPCD) in 1992, numerous studies investigating these devices have been published. The deployment success rates reported in 2,292 patients for VHD is 97%, ranging from 88 to 100%. For HPCD, the mean deployment success rate resulting from 622 published patients leads to an identical result of 97%, ranging between 91 and 100%. For time to hemostasis, data have been analyzed according to the four different clinical situations, depending on level of anticoagulation (none or full) and the time of sheath removal (immediate or delayed). In randomized studies, when compared with the manual control groups, both devices revealed a statistically significant reduction in time to hemostasis: 12 to 16 minutes less for diagnostic catheterization and 14 to 30 minutes less for PTCA. As for minor local complications, no clinically relevant differences seem to exist. None of these devices has been proven to reduce major local complications. Prospective trials addressing early mobilization after percutaneous transluminal coronary angioplasty and the cost effectiveness of arterial closure devices in defined subgroups are warranted.     

False aneurysm with median nerve palsy after iatrogenic brachial artery puncture

We report on a case in which a patient on oral anticoagulation for her aortic valve replacement, with an International Normalised Ratio of 2.13, developed a false aneurysm of the brachial artery after a routine arterial puncture, despite direct pressure to the aspiration site. The false aneurysm was complicated by the development of median nerve palsy.     

Generation of chicken Z-chromosome painting probes by microdissection for screening large-insert genomic libraries

From October 1994 to November 1995, 150 male eligible patients were randomly assigned to Palmaz-Schatz stent implantation through 6 French catheters using the femoral (puncture) (n = 56), radial (puncture) (n = 56), or brachial (cutdown) (n = 38) approach at 6 participating Belgian centers. Acenocoumarol was given for 1 month after stenting. End points: Primary-entry site complications (bleeding, haematoma, transfusion, occlusion, surgery) poststent implantation. Secondary-success rate, stent thrombosis, Q or non Q wave MI, repeat PTCA, CABG, CVA, haemorrage, death. There were no statistically significant differences between the three groups for base line and angiographic patient characteristics, procedural characteristics, in hospital outcome, average hospitalisation time after stenting, events during the month after stenting, or local complications at 1 month follow-up. The only statistically significant difference was the arterial time of the procedure: mean +/- SD (minutes) brachial 31.0 +/- 10.02 *P < 0.001, femoral 42.2 +/- 21.8, radial 55.8 +/- 31.3 **P < 0.0001 (*brachial vs. femoral, **brachial vs. radial). There was a clear trend toward more technical difficulties and more problems with the radial approach. In each group: vascular surgery at entry site: 0%, blood transfusion: 0%. In our study, local complications and length of hospital stay were similar with the three possible approaches, and brachial approach was associated with a shorter arterial time.     

Superselective arterial catheterization in the rabbit

RATIONALE AND OBJECTIVES: To improve the safety and success of selective and superselective arterial catheterization in the rabbit. METHODS: A 2-F catheter introducer system was devised that consisted of the sheath of an 18-gauge, 5.1-cm sheath needle and a hemostatic valve attached to the hub of the sheath. The system was tested in 14 adult male New Zealand white rabbits with regard to ease of insertion and facilitation of superselective arterial catheterization. RESULTS: The introducer system was easily placed in all rabbits, and no bleeding was seen around the sheath at the puncture site. Preshaped 2-F polyethylene catheters were readily inserted through the assembly and sheath. The valve prevented bleeding from around the catheter, and the side-arm flush tube served as a route for heparinization. The system greatly facilitated the manipulation of 2-F angiographic catheters. CONCLUSION: Use of the introducer system with a 2-F polyethylene angiographic catheter improved the success of selective and superselective arterial catheterization in the rabbit.     

Role of anticardiolipin antibodies in young persons with migraine and transient focal neurologic events: a prospective study

OBJECTIVES: The aim of this study was to determine the relative risks of pediatric diagnostic, interventional and electrophysiologic catheterizations. BACKGROUND: The role of the pediatric catheterization laboratory has evolved in the last decade as a therapeutic modality, although remaining an important tool for anatomic and hemodynamic diagnosis. METHODS: A study of 4,952 consecutive pediatric catheterization procedures was undertaken. RESULTS: Patient ages ranged from 1 day to 20 years (median 2.9 years). One or more complications occurred in 436 studies (8.8%) and were classified as major in 102 and minor in 458, with vascular complications (n=189; 3.8% of procedures) the most common adverse event. Arrhythmic complications (n=24) were the most common major complication. Death occurred in seven cases (0.14%) as a direct complication of the procedure and was more common in infants (n=5). Independent risk factors for complications included a young patient age and undergoing an interventional procedure. CONCLUSIONS: Complications continue to be associated with pediatric cardiac catheterization. Efforts should be directed to improving equipment for flexibility and size, and finding alternative methods for vascular access. Patient age and interventional studies are risk factors for morbidity and mortality.     

Morphology of protein-protein interfaces

This study investigated the usefulness of collagen plugging with VasoSeal in patients after PTCA compared to a control group having identical sheath dwell times and therefore comparable levels of anticoagulation. A total of 150 patients were enrolled in this prospective and randomized study. Sheaths were pulled at exactly 5 h after arterial puncture. Time to hemostasis and local complications were determined. There were no statistical differences in baseline characteristics. The mean time to hemostasis in the collagen group was significantly shorter (3 +/- 3 min) than that of the control group (17.4 +/- 7 min). At 24 h, 23% of the collagen group patients had a small, 1% a medium and 4% a large hematoma. In the control group, 32% had a small, 4% a medium sized, but no patient a large hematoma. After collagen, one patient developed a pseudoaneurysm needing vascular surgery. In the control group, no major complication occurred. Compared to patients with manual compression at an identical sheath dwell time and an identical level of anticoagulation, there was a significant reduction in time to hemostasis but no statistical difference regarding local complications. Although the incidence of medium or large hematoma was low, the trend towards a decreased risk of smaller hematomas seemed to be counterbalanced by an increased risk of larger hematomas.     

Splenic hypofunction in cirrhosis is not associated with increased risk for infections

Femoral artery pseudoaneurysm is a major problem in patients undergoing cardiac catheterization. This study describes our experience with 5 French (5 F) and 7 French (7 F) introduction sheaths and 7 investigators at our institution regarding the incidence of pseudoaneurysms. During 54 months (1/1990-6/1994) 8715 consecutive patients after diagnostic cardiac catheterization were first clinically checked for pseudoaneurysm and in case of suspicion a duplex sonography was performed. In 86 (1%) patients, 44 (52%) women and 42 (48%) men, mean age 63 +/- 9.7 years we observed this complication by duplex ultrasound. 54 (62%) patients had arterial hypertension, 18 (20%) diabetes and only 3 (3.6%) had peripheral arteriosclerosis. An antithrombotic medication was used in 60% (52 patients). As compared to a control group of 450 consecutive patients a pseudoaneurysm was significantly more likely to occur in patients with a history of hypertension (63% vs 25%, p < 0.0001). Women are also at higher risk representing 51% of all pseudoaneurysms as compared to 29% in the control group (p < 0.0001). Using 7-F catheters more pseudoaneurysms occurred (82/7183; 1%) than using 5 F (4/1532; 0.2%) introduction sheaths (p = 0.0005). There were also significantly more pseudoaneurysms caused by investigator 1 (21/787; 2.7%) as compared to the other investigators (65/7829; 0.8%), (p = 0.0002). Investigator 1 had a more distal puncture technique than the others. Pseudoaneurysms complicating cardiac catheterization occur 5-times more frequent using 7 F (1%) as compared to 5 F catheters (0.2%). Moreover distal puncture site is associated with a higher frequency of pseudoaneurysms.     

The effect of early ambulation on hematoma formation and vascular complications following 7 French diagnostic cardiac catheterization

OBJECTIVE: To assess the feasibility and safety of early ambulation 3 to 4 h after diagnostic 7 French cardiac catheterization. DESIGN: Randomized, single-blind assignment to one of 3, 4 or 6 h ambulation postcardiac catheterization groups. SETTING: Tertiary care community hospital in an urban region. PATIENTS: Eight hundred and seventy-four consecutive inpatients and out-patients presenting for routine diagnostic cardiac catheterization. INTERVENTION: Hematoma formation and other vascular complications recorded at the time of discharge and 24 h later. MAIN RESULTS: No significant difference in hematoma formation rates was noted among patients mobilized at 3 h (3.6%), 4 h (4.8%) or 6 h (3.2%). Late hematoma formation occurred in 2.3% of patients. Other vascular complications were very rare. Reported rates of hematoma formation varied significantly (P < 0.05) among physicians, ranging from 0.9% to 8.0%. CONCLUSIONS: Early ambulation of patients 3 to 4 h after routine diagnostic 7 French cardiac catheterization is both safe and feasible. These findings could result in more efficient recovery bed utilization, reduced nursing costs and improved patient compliance with bed rest.     

Percutaneous suture closure of the femoral artery access after diagnostic heart catheter examination or coronary intervention

BACKGROUND AND OBJECTIVE: Alternative methods to the conventional one of external compression with a pressure bandage over the site of arterial puncture after percutaneous catheter introduction for coronary angiography or transluminal balloon coronary angioplasty have failed to reduce the rate of vascular complications. This study was undertaken to assess the complication rate of a percutaneously introduced suturing device (Techstar, Perclose). PATIENTS AND METHODS: To achieve immediate haemostasis and thus shorten post-interventional immobilisation the technique of percutaneous suturing of the femoral artery was used in 1030 consecutive patients (793 men, 237 women; mean age 58.6 years) without obstructive vascular disease or local vascular complications. RESULTS: Percutaneous suture closure with primary haemostasis was successful after 137 of 153 coronary angioplasties (89.5%) and after 786 of 977 left heart catheterisations (89.6%). Early mobilisation, after at most 4 hours, was possible in 923 patients with successful suture closure (89.6%). The overall complication rate was 0.78%. CONCLUSION: Percutaneous suture repair of the femoral artery after cardiac catheterisation is a safe and effective method to achieve immediate haemostasis. However, controlled studies are needed to demonstrate harmlessness of early mobilisation.     

Consensus diagnosis and treatment of arterial intermittent claudication. Central Guidance Organization for Peer Review

Intermittent claudication is an indicator of increased risk of cardiac and cerebrovascular morbidity and mortality and as such a reason to look for modifiable risk factors for atherosclerosis. A vascular anamnesis and physical examination can reliably exclude presence of peripheral arterial occlusive disease in the lower extremities, but cannot reliably demonstrate its presence. Certainty about presence or absence of peripheral arterial occlusive disease can be obtained by determination of an ankle-brachial blood pressure index. The main method for the diagnosis of severity and localisation of stenoses and occlusions in the arteries to the legs is the echo-Doppler (duplex) examination. With this method the feasibility of percutaneous transluminal angioplasty (PTA) can also be determined. Consequently, angiography has lost importance as a diagnostic method and is only still indicated as part of an interventional treatment (operation or PTA). Treatment should be aimed at both amelioration of symptoms and reduction of risk factors for atherosclerosis. A key-stone of the treatment is cessation of smoking. The role of pharmacotherapy in reducing symptomatology is only limited. Walking exercise can have a positive effect on walking distance and should always be tried. PTA is the treatment modality of first choice for stenoses in the aortoiliac and femoropopliteal arteries. For segmental occlusions in the iliac pathway, also recanalisation by means of PTA (in combination with stent placement) is a justifiable treatment option. In all other cases operative revascularisations give good functional results. Invasive treatments for patients with intermittent claudication should be performed within a multidisciplinary team.     

Percutaneous cardiac catheterization and atrial balloon septostomy in pediatrics

Between November, 1971, and July, 1975, 688 patients ranging in age from six hours to 21 years have undergone percutaneous transfemoral venous and/or arterial catheterization at the University of Oregon Health Sciences Center. This represents 93% of all venous catheterizations of the right side of the heart and 97% of all arterial catheterizations of the left side of the heart in the pediatric age range. One hundred and ninety-five patients (29% of the group) weighed 5 kg or less and 133 (20% of the group) were neonates. There were virtually no complications following the venous studies. The complication rate following percutaneous arterial studies is lower than is the reported experience with cut-down arteriotomies. Long-term survival following percutaneous atrial balloon septostomy in D-transposition of the great arteries was comparable to that following cut-down balloon septostomy. The ease of accomplishment, significantly lower complication rate, and successful accomplishment of atrial balloon septostomy prompt us to advocate that the percutaneous technique of cardiac catheterization be extended to include the neonate and young infant who weighsless than 5 kg.     

Mechanisms of sudden death and autopsy findings in patients with Arnold-Chiari malformation and ventriculoatrial catheters

Neurological and vascular complications of Arnold-Chiari malformation treated with ventriculoatrial shunting may result in sudden or unexpected death. Two patients with Arnold-Chiari malformation and ventriculoatrial shunting had variable clinical manifestations and diagnostic difficulties. A 3-year-old girl with a 1-day history of right-sided heart failure died unexpectedly soon after cardiac catheterization. At autopsy examination an adherent thrombus around the ventriculoatrial catheter tip, pulmonary infarction, and embolic pulmonary arterial hypertensive changes were found. In the second case, a 21-year-old man died suddenly after a brief episode of dyspnea. He had a 1-year history of "asthma" before death. Autopsy examination confirmed pulmonary infarction and embolic pulmonary arterial hypertensive changes. There was no histological evidence of asthma. Deaths in both cases were due to pulmonary infarction stemming from thromboemboli derived from ventriculoatrial catheterization. Both patients had evidence of long-standing clinically unsuspected vascular disease, which may have contributed to death. Cardiac catheterization may also have precipitated death in the first patient. Other possible problems leading or contributing to sudden death in such patients include pulmonary hypertension with chronic cor pulmonale, airway obstruction from recurrent laryngeal nerve paralysis, and shunt blockage with acute hydrocephalus. Lethal brainstem compression may also accompany relatively minor trauma associated with chronic cerebellar tonsillar herniation in these patients.     

Formation, therapy and prevention of false aneurysm of the femoral artery following diagnostic and interventional heart catheterization

OBJECTIVE: As pseudoaneurysm of the femoral artery after catheter introduction is a frequent complication, its causes and therapeutic options were investigated in a large patient collective. PATIENTS AND METHODS: In a prospective study with colour-Doppler duplex sonography of 6928 patients after diagnostic and of 3764 after interventional cardiac catheterisation, pseudoaneurysms were diagnosed in 80 patients (0.75%), 46 after diagnostic (0.66%) and 34 after interventional (0.9%) catheterisation. RESULTS: The incidence was higher in women than men (1.33% vs 0.58%; P < 0.05). Anticoagulation after sheath removal was the leading risk factor (n = 55, 68.8%), especially after interventional coronary intervention 85.3 vs 56.5%, P < 0.05). Local compression under duplex sonography monitoring was undertaken in 69 patients (86.3%), achieving aneurysmal obliteration in 53 (76.8%). Spontaneous thrombosis occurred in 15 of the remaining 27 patients, and surgical closure became necessary in 12. CONCLUSIONS: These data indicate a risk profile for the occurrence of pseudoaneurysm after cardiac catheterisation which can be dealt with by preventive measures. Local compression under duplex sonographic monitoring was the treatment of choice with a high success rate and low incidence of complications.     

Repair of femoral pseudoaneurysm after cardiac catheterization: utility of extraperitoneal iliac control

Femoral artery lesions may occur after cardiac catheterization or percutaneous transluminal coronary angioplasty (PTCA). The incidence of pseudoaneurysm following transfemoral catheterization ranges from 0.21 to 6.25%. Among 3162 cardiac catheterization procedures thirteen (0.41%) patients presented a femoral pseudoaneurysm requiring surgical repair. The Authors reported their technical consideration about the utility of extraperitoneal iliac control during surgical repair of femoral artery pseudoaneurysm due to cardiac catheterization.     

Registry of activities of the Section of Hemodynamics and Interventional Cardiology in 1997

The results of the Spanish Registry of Hemodynamic and Interventional Cardiology in 1997 are presented. The Registry collects the activity of 83 centers which constitute all the cardiac catheterization laboratories in Spain. The main activity was adult cardiac catheterization in 75 centers and exclusively pediatric cardiac catheterization in 8. A total of 72,370 diagnostic catheterization procedures, 80% coronary angiographies (57,960; 1,462 per million inhabitants), were performed which represents a 13% total increase compared to 1996. Coronary intervention increased by 23% compared to 1996, for a total number of 18,545 procedures. The ratio of coronary interventions per million inhabitants was 468. Success rates of coronary interventions (91.3%) and complications (3.7%) were similar to those registered in previous years. In the specific field of revascularization devices, there has been a dramatic increase in the use of stents. In 1997, coronary stents were employed in 11,417 cases (a 61% increase compared to 1996) which represents 61.5% of all coronary revascularizations procedures. A total of 14,170 prosthesis were implanted, 72% in a elective way, with a low rate of complications (0.95% subacute closure; 1.45% myocardial infarction and 0.75% mortality). Compared to 1996, directional coronary atherectomy (92 procedures) showed a slight decrease, whereas rotational atherectomy (554 procedures) increased by 49% with double the number of centers performing this technique. As in previous years, a slight decrease (7% compared to 1996) in adult valvuloplasties (559 vs 599) was noted. Pediatric interventional procedures decreased by 17% (465 vs 558 procedures) compared to the 1996 Registry.     

The surgical management of catheter injuries of the brachial artery

In 84 patients the wrist pulses were lost after diagnostic left heart catheterization via the brachial artery. Sixty-six of these patients underwent surgical exploration of the brachial artery for restoration of pulsatile arterial flow to the hand. This aim was achieved in 64 instances. In all cases, the artery was found to be occluded by fresh thrombus. In 36 patients, balloon thrombectomy and accurate arterial closure were successful. In the remainder, in addition to thrombectomy, indentification of an area of damage to the arterial wall required additional surgical measures, usually in the form of resection and anastomosis. The surgical approach to this problem and the importance of the recognition and treatment of arterial wall damage by the catheter are stressed in this paper.     

Sheath pulling immediately after PTCA: comparison of two different deployment techniques for the hemostatic puncture closure device: a prospective, randomized study

Sheath pulling immediately after percutaneous transluminal coronary angioplasty (PTCA) increases patients' comfort, decreases burden for the medical staff, and may reduce hospital costs by shortening the length of stay. Immediate sheath pulling in anticoagulated patients with a low risk of bleeding complications is feasible using hemostatic devices. For the hemostatic puncture closing device (HPCD), published data regarding sheath pulling in patients immediately after PTCA is limited. Furthermore, no study addressed the question whether the recommended deployment time (DT) of 30 min can be reduced to a few minutes. We, therefore, performed a prospective study, randomizing 140 patients to a DT of 5 and 30 min, respectively. There were no statistical differences in gender, age, height, weight, or cardiovascular risk factors between the two groups. Blood pressures measured invasively immediately before sheath removal were comparable. Activated coagulation time just prior to sheath removal was 227 +/- 52 sec in the DT-5 group and 223 +/- 37 sec in the DT-30 group. After deployment, 74% of the DT-5 patients and 71% of the DT-30 patients showed immediate and complete hemostasis. The remaining patients showed only little oozing with complete hemostasis at the time of the final device removal. Hematoma size after 24 hr was 6.2 +/- 4.4 cm2 for DT-5 and 6.8 +/- 8.2 cm2 for DT-30 patients. There was no statistical difference between both groups. No severe bleeding or major complications were observed in either group. Thus, the use of a collagen system with an intra-arterial anchor (HPCD) is effective and safe when sheaths are pulled immediately after PTCA. The reduction of deployment time from 30 to 5 min is not related to an increased risk of bleeding or other vascular complications; patients can be transferred much faster to the ward, therefore reducing the burden on the personnel in the catheterization laboratory and increasing patients' comfort by allowing them to return to their rooms without a sheath.     

Transbrachial arterial catheter angiography. Technique, indications, complications

In a large group of patients, most of whom were attending a department of vascular surgery, who underwent arterial digital subtraction angiography (DSA), a transfemoral approach was not possible in 9%. Therefore in 142 cases transbrachial arterial angiography was electively performed with 4-F or 5-F catheters. This method proved to be a safe and reliable alternative, though the examination technique was more demanding and the complication rate somewhat higher. It offers clear advantages over a transaxillary or translumbar approach. Special attention is paid to the role of transbrachial arterial DSA in evaluating the descending aorta and the peripheral outflow in the legs and to its usefulness in certain angioplasty manoeuvres.     

The incidence of artery puncture with central venous cannulation using a modified technique for detection and prevention of arterial cannulation

BACKGROUND: Cannulation of the central circulation is essential for management of patients who require major surgery, and for patients who are critically ill. Arterial puncture is the most frequent complication associated with central venous cannulation, and is potentially fatal. Detection of arterial puncture can be problematic, especially in patients with cyanotic congenital heart disease. METHODS: One thousand eleven consecutive cardiothoracic and vascular surgical patients who required central venous cannulation were studied using a new technique for detection of arterial puncture and prevention of arterial cannulation. This technique involves continuous pressure transduction of the steel introducer needle. Central venous cannulation was attempted in all patients. The sites of attempted catheterizations, number of arterial punctures and cannulations, and the number of successful catheterizations were noted. All patients were treated in accordance with standard anesthetic and surgical techniques in the institution. RESULTS: One thousand one hundred seventy-two central venous catheters were placed. The overall success rate was 99.6%. The incidence of arterial puncture was 9.3% for central venous cannulation attempts of the internal jugular, subclavian, and femoral veins. No arterial cannulation occurred, and none of the patients had significant complications. Congenital heart disease patients had a higher incidence of arterial puncture (14.1%) and a lower rate (96.8%) of successful cannulation. CONCLUSION: Pressure transduction of the steel needle is a useful technique for detecting arterial puncture and preventing arterial cannulation during attempts to achieve central venous cannulation.     

Positioning post-outpatient cardiac catheterization

The optimal positioning post-outpatient cardiac catheterization is a largely unexplored area of research. Traditionally, patients have been placed supine, with the head of the bed (HOB) flat. This study sought to explore the influence of three different post-procedure positions on the incidence of complications and patient perceptions of satisfaction. Sixty-nine patients were randomized into three groups immediately after hemostasis of the arterial puncture site was achieved. Group 1 patients were placed supine with the HOB flat. Group 2 patients were placed on their sides, with the affected extremity straight. Group 3 patients were placed on their backs, with the HOB at 15-30 degrees. Endpoints included the presence of any complication (bleeding, hematoma formation or expansion, back pain and urinary retention) and patient comfort and satisfaction with the randomized position. Patients were asked prior to discharge to select the position they would have preferred post-procedure. Selection of an alternative position was felt to indicate dissatisfaction with the randomized position. Ten patients in Group 1, and nine patients in Group 2 and Group 3 experienced a complication (X2 = 3.682, df = 1, p = 0.05). Eighty-five percent of Group 1 patients selected an alternative position vs. 24% of those patients in Group 2 and Group 3 (X2 = 27.6, df = 1, p < .001). Conclusion: varying patient position post-outpatient cardiac catheterization is at least as safe as the traditional supine position and is more comfortable for patients.