Femoral artery hemostasis using an implantable device (Angio-Seal) after coronary angioplasty.

Coronary catheter interventional procedures are associated with risk of access site complications. We report our experience with Angio-Seal, an implantable hemostasis device, when used in the femoral artery after coronary angioplasty procedures. Sixty-eight patients were studied. Their average age was 63 years; 84% of the patients were male. All had 8 French access sheaths and received bolus heparin (mean dose 12,690 U). The arterial sheaths were removed an average of 455 min after the conclusion of the procedure, when the activated clotting time was 220 +/- 94 sec (range 97-503 sec). The hemostasis device was successfully deployed in 63 patients (93%). The average time to achieve complete arterial hemostasis was 4.4 +/- 8.9 min (range 0-45). Immediate, total hemostasis without requiring any form of external pressure was obtained in 37 of these patients (54%). the incidence of complications was as follows: significant bleeding occurred in 9 patients (13%); there were 2 hematomas (3%); there were no vascular or infectious complications. One device embolization occurred when the connecting suture broke and the intravascular anchor was lost; no clinical sequelae resulted, and manual hemostasis was successful. In four other patients, the device did not deploy and was removed entirely, followed by uneventful manual hemostasis. Follow-up for 2 months revealed no late sequelae in any patient, and complete absorption of the device was documented by ultrasound study in all cases. We conclude that this implantable device can achieve arterial hemostasis quickly and safety when used in anticoagulated patients after coronary interventional procedures.

Rapid arterial hemostasis and decreased access site complications after cardiac catheterization and angioplasty: results of a randomized trial of a novel hemostatic device.

OBJECTIVES: This study was performed to test the safety and efficacy of a novel bioabsorbable hemostatic puncture closure device deployed through an arterial sheath. BACKGROUND: Cardiac catheterization procedures are associated with a risk of complications at the arterial access site. Increasing numbers of interventional procedures requiring large sheaths or intense anticoagulation underline the need for secure, rapid methods of obtaining hemostasis at the time of sheath removal. METHODS: We conducted a randomized, multicenter trial in 435 patients undergoing cardiac catheterization or angioplasty at eight participating centers. In 218 patients, hemostasis was achieved using the device (group I); 217 patients were assigned to the manual pressure control group (group II). RESULTS: There were no significant differences in baseline characteristics. Time to hemostasis was considerably shorter in group I (2.5 +/- 15.2 vs. 15.3 +/- 11.7 min [mean +/- SD], p < 0.0001). The deployment success rate for the device was 96%, and 76% of group I patients experienced immediate (within 1 min) hemostasis. Complication rates were lower in group I for bleeding, hematoma and occurrence of any complication. There was no difference in the small incidence of pseudoaneurysm formation. There was no change in either group in the ankle/brachial systolic blood pressure index. Ultrasound follow-up studies 60 days after device deployment revealed complete absorption of the device in all cases. Subgroup analysis revealed particular benefit in patients undergoing interventional procedures. The administration of heparin was associated with a significantly higher complication rate in the manual pressure control group, whereas heparin had no effect on hemostasis time or complication rates in the device group. CONCLUSIONS: This sheath-deployed, bioabsorbable device provides a safe and effective means of obtaining rapid arterial hemostasis after cardiac catheterization procedures. It appears to be particularly useful in those patients most at risk for access site complications.

Immediate arterial hemostasis after cardiac catheterization: initial experience with a new puncture closure device.

A novel device for obtaining arterial hemostasis after invasive procedures was tested in 30 patients undergoing diagnostic catheterization (26 patients) or coronary angioplasty (4 patients). The device is deployed through an arterial sheath and forms a positive mechanical seal both inside and outside the defect in the arterial wall. The components are all bioabsorbable. Thirteen patients received a heparin bolus during the catheterization procedure. The activated clotting time recorded in 15 patients just prior to device deployment averaged 264 sec. 29 of 32 attempted device deployments were successful (91%); and the remaining 3 devices pulled completely out as called for by design in the event of incomplete deployment. Twenty-nine patients ultimately achieved successful hemostasis using the device, with the other patient receiving manual hemostasis. Of these 29, hemostasis was immediate and complete in 19 patients. Light digital pressure was required in another 8 patients for less than 5 min. There was minor delayed bleeding requiring supplemental light pressure in several cases. A total of 11 patients required supplemental pressure in addition to the hemostasis device. The use of bolus heparin was significantly (P = 0.05, Fisher's exact test) related to the requirement for supplemental pressure. Three patients developed hematomas, one of which was present prior to device deployment. The other two patients had received bolus heparin. No patient required transfusion or surgical repair. There was no change in the ankle/brachial systolic blood pressure index after device deployment or at late (30-60 day) follow-up. Ultrasound studies revealed no significant pathology relative to the device.(ABSTRACT TRUNCATED AT 250 WORDS)

Atrial pacing during percutaneous transluminal coronary angioplasty: results and comparison with exercise treadmill testing.

Right atrial pacing (RAP) was used to immediately assess improvement in threshold for myocardial ischemia in 23 patients undergoing angiographically successful percutaneous transluminal coronary angioplasty (PTCA). Multiple coronary lesions were present in 19 patients, and 15 had incomplete revascularization. All patients had RAP done immediately before and after completion of all dilatations, and in 13 patients pre- and post-PTCA exercise treadmill tests (ETT) were also performed. Angina occurred in 16 (70%) patients during pre-PTCA RAP, but in only 4 (17%) after PTCA (p less than .05). The electrocardiogram was positive for ischemia (horizontal or downsloping ST depression greater than or equal to 1 mm) in 18 patients (78%) during pre-PTCA RAP. However, 13 patients (57%) continued to have an ischemic response during post-PTCA RAP (not significant-NS). In 4 patients with multiple coronary lesions who had sequential pacing studies after PTCA of each lesion, the maximum degree of ST depression decreased by 1 mm or more after each dilatation in 3 patients but remained greater than or equal to 1 mm in all. In the 13 patients undergoing both RAP and ETT, angina developed in 7 during pre-PTCA RAP and in 2 after PTCA (p less than .05), compared with 8 and 3 (p less than .05) during pre- and post-PTCA ETT, respectively. Ischemic ST depression occurred in 9 patients during pre-PTCA RAP and in 6 after PTCA (NS), and in 8 and 6 (NS) during pre- and post-PTCA ETT, respectively. Concordance between the two tests was good.(ABSTRACT TRUNCATED AT 250 WORDS)

Pseudonormalization of T-waves during coronary angioplasty.

Myocardial ischemia has been reported occasionally to produce transient T-wave normalization in certain patients. We present a case of "pseudonormalization" of T-waves occurring in the setting of coronary angioplasty. This case illustrates the potential of the transient coronary occlusion which occurs during coronary angioplasty as a model for understanding acute myocardial ischemia.

Immediate and short-term benefit of multilesion coronary angioplasty: influence of degree of revascularization.

The safety and short-term therapeutic benefit of multilesion percutaneous transluminal coronary angioplasty was assessed in 135 patients, 66 of whom had a minimum of 6 months of follow-up study. Primary success, defined as successful dilation of the most critical lesion or all lesions attempted without major in-hospital complications was obtained in 117 (87%) of the 135 patients. Cardiac complications associated with the procedure were uncommon; prolonged angina occurred in 5% and myocardial infarction in 3%; emergency coronary bypass surgery was performed in 4% of the patients. There were no deaths. Complete revascularization was achieved in 46% of the 117 patients with a primary success. Of the 66 patients eligible for 6 month follow-up, 80% had an uncomplicated course and required no further procedures. Clinical improvement by at least one angina functional class was observed in 90% of the patients. Cardiac events such as the need for a second revascularization procedure were significantly more common in patients who had incomplete versus complete revascularization (35 versus 9%; p = 0.018). Repeat coronary angiography performed an average of 5 months after angioplasty revealed restenosis in 18 of 22 symptomatic patients and 3 of 9 asymptomatic patients. Restenosis occurred at the site of a single dilation in 12 patients, at two sites in 8 patients and at three sites in 1 patient. Thus, multilesion coronary angioplasty is an important therapeutic option for selected patients with multivessel disease and can be performed with relatively low risk. Improvement in angina status can be expected even in patients who have incomplete revascularization.(ABSTRACT TRUNCATED AT 250 WORDS)

The effects of Valsalva maneuver on global and segmental left ventricular function in presence and absence of coronary artery disease.

To determine the effects of the Valsalva maneuver on global and regional left ventricular function, single-plane left ventriculograms were performed in the 30-degree right anterior oblique projection in 50 patients during normal breath holding and during the late strain phase of the Valsalva maneuver. Thirty-one patients had significant coronary artery disease (greater than 70% luminal narrowing in a major coronary artery). Ventriculograms were analyzed for determination of ejection fraction, end-diastolic, and end-systolic volumes. Regional wall motion was analyzed by a chord method of calculating segmental fractional shortening. Ejection fraction increased significantly in the entire group of patients (62 +/- 16% to 70 +/- 19%, p less than 0.0001), while both end-diastolic (105 +/- 33 cc to 88 +/- 34 cc, p less than 0.0001) and end-systolic volumes (43 +/- 29 cc to 30 +/- 29 cc, p less than 0.0001) showed striking reductions with Valsalva maneuver. Patients without significant coronary disease usually exhibited global augmentation in left ventricular function, while those with coronary disease often exhibited only segmental improvement. This augmentation appeared to be dependent on the patency of the supplying coronary vessel.

The occurrence of angiographically detected intracoronary thrombus in patients with unstable angina pectoris.

To examine the role of intracoronary thrombus (ICT) in unstable angina, we reviewed the coronary arteriograms of 83 patients with unstable angina (group I) and 37 patients with stable angina (group II) for angiographic evidence of ICT. Group I and group II patients were similar with respect to mean age, presence of single and multiple vessel disease, and past history of myocardial infarction. Group I patients had no ECG or creatine kinase enzyme evidence of acute myocardial infarction. The angiographic criteria for ICT included an intracoronary filling defect, intraluminal staining, and total coronary artery occlusion with convex dye outline. ICT was found in 10 of 83 patients in group I (12.0%) vs 0 of 37 patients in group II (p less than 0.05). These findings suggest that in some patients coronary artery thrombosis plays an important role in the pathogenesis of unstable angina.

Embolus to the right atrium simulating myxoma.

A space-occupying mass of the right atrium was found by two-dimensional echocardiography and angiography in a 68-year-old woman whose clinical diagnosis indicated multiple pulmonary emboli. Since right heart myxomas frequently cause pulmonary thromboembolism, the patient was initially diagnosed by noninvasive and invasive techniques as having a right atrial myxoma. Surgery, however, revealed the pathologic findings of large thrombi of the right atrium, femoral and iliac veins, and pulmonary arteries. This case vividly demonstrates that deep venous thrombosis may embolize and lodge in the right atrial cavity simulating a right atrial myxoma.