Hemostasis Device Research Articles

Endoscopic conjunctivodacryocystorhinostomy with Jones tube placement

Objective Conjunctivodacryocystorhinostomy (CDCR) with Jones tube placement as described by Jones has traditionally been performed as an “open” or external procedure by means of medial canthal incision. Application of endoscopic technique for CDCR with Jones tube placement has not been well described in the peer-reviewed literature. Design Retrospective nonrandomized comparative trial. Participants Ten patients with epiphora secondary to canalicular stenosis. Methods A total of 13 consecutive CDCR with Jones tube procedures were reviewed. Five procedures (performed predominantly in the early study period) were done by means of a traditional external approach with a medial canthal incision. Eight procedures were performed with an intranasal endoscopic approach and instrumentation with Jones tube placement under direct endoscopic visualization. Main outcome measures Total operative time, estimated blood lost, intraoperative, and postoperative complications and need for secondary surgery were evaluated. Results All procedures were successfully completed with no intraoperative complications. Average operative time was 59 minutes in the endoscopic group and 74 minutes in the external group. Average blood loss was 3.5 ml and 4.4 ml in the endoscopic and external groups, respectively. Postoperative adjustment of tube size or position (performed as an office procedure with topical/local anesthesia) was common: five of eight endoscopic and three of five external approach. Two patients in the endoscopic group required secondary surgery for anatomic reasons. Ultimately, all cases in both groups demonstrated patent, retained Jones tubes and relief of epiphora. Conclusion Endoscopic technique appears to be a reasonable approach for CDCR with Jones tube placement. Operative time and blood loss were comparable in the two groups, with the endoscopic group being slightly lower for each variable. Endoscopic Jones tube placement can be accomplished with readily available instrumentation. In this series, we did not find it necessary to use laser, radiofrequency, or monopolar devices for intranasal hemostasis.

The efficacy of laparosonic coagulating shears for arterial division and hemostasis in porcine arteries.

Recently, the laparosonic coagulating shears (LCS) have been used widely in laparoscopic surgery. In the current study, the usefulness of LCS for arterial division and hemostasis was examined in porcine arteries. Porcine arteries of several diameters (1, 3, and 5 mm) were removed and divided using LCS with different blade modes: shear, blunt, and flat. The division time and bursting pressure were registered. Additionally, divided sections stained by the Azan-Mallory method were observed microscopically. The division time was dependent on the blade modes used. With the flat mode, the bursting pressure of 5-mm arteries was significantly higher than the bursting pressure with shear and blunt modes. Histologically, cavitation and mild degeneration of the vessel walls occurred adjacent to the cutting edge. The LCS is a safe and useful device for arterial division and hemostasis for 5-mm arteries if an adequate blade mode is used.

Complications Related to Vascular Hemostasis Devices

Complications Related to Vascular Hemostasis Devices

Vasoseal hemostasis following coronary interventions with Abciximab.

Femoral arteriotomy management using a collagen vascular hemostasis device (VasoSeal) was studied in 50 consecutive patients following interventional coronary procedures performed with Abciximab (ReoPro). Low dose weight adjusted or no heparin was employed. The first 25 patients were permitted to sit up after 6 hours with ambulation the following day. The second 25 patients were allowed to sit up after 1 hour and ambulate after 6 hours. Despite early activity and ambulation, there were no hemorrhagic complications including hematoma, pseudoaneurysm, blood transfusion, or surgical repair. Hemoglobin and platelet counts remained stable overnight prior to discharge. This pilot study demonstrates the potential efficacy of VasoSeal in achieving early sheath removal and ambulation in patients undergoing interventional procedures using ReoPro.

Vasoseal hemostasis following coronary interventions with Abciximab

Femoral arteriotomy management using a collagen vascular hemostasis device (VasoSeal, Datascope Corporation, Montvale, New Jersey) was studied in 50 consecutive patients following interventional coronary procedures performed with abciximab (ReoPro, Eli Lilly and Company, Indianapolis, Indiana). Low-dose weight-adjusted or no heparin was employed. The first 25 patients were permitted to sit up after 6 hours with ambulation the following day. The second 25 patients were allowed to sit up after 1 hour and ambulate after 6 hours. Despite early activity and ambulation, there were no hemorrhagic complications including hematoma, pseudoaneurysm, blood transfusion, or surgical repair. Hemoglobin and platelet counts remained stable overnight prior to discharge. This pilot study demonstrates the potential efficacy of VasoSeal in achieving early sheath removal and ambulation in patients undergoing interventional procedures using ReoPro.

Improved Clinical Effectiveness With a Collagen Vascular Hemostasis Device for Shortened Immobilization Time Following Diagnostic Angiography and Percutaneous Transluminal Coronary Angioplasty

This study prospectively compared immobilization time followed by use of a vascular hemostasis device (VasoSeal) versus manual compression to achieve hemostasis at the arterial puncture after angiography and percutaneous transluminal coronary angioplasty (PTCA). The trial shows that use of a vascular hemostasis device results in earlier mobilization, even in highly anticoagulated PTCA patients compared with manual compression, with no statistically significant complications.

Groin complications associated with collagen plug closure of femoral arterial puncture sites in anticoagulated patients.

A retrospective study was conducted to determine the frequency and nature of groin complications when the Vasoseal (Datascope Corp., NJ) hemostasis device was used on 204 occasions to enable removal of the groin sheath in anticoagulated patients. The patients had undergone balloon angioplasty (53%), coronary stenting (20%), and diagnostic angiography (27%). Complications included vascular surgery in 5% including 2 embolized collagen plugs, failure to achieve hemostasis (2%), late external bleeding (2%), purulent discharge (1.5%), a minor ooze of blood (7%), hematomas >6 cm (6%), and hematomas < or = 6 cm (7%). One or more complications occurred with 64 of 204 (30.5%) uses. Multivariate analysis identified diagnostic angiography to be associated with a reduced risk of complications [odds ratio (OR) 0.25], while stent procedure (OR 2.7) and female gender (OR 2.5) were associated with increased risk. This complication rate is similar to other reported series except for a higher rate of vascular surgery. The high incidence of anticoagulation in our study patients (94%) may explain this difference. We recommend caution and adherence to the recommended technique when the device is used in anticoagulated patients.

Radical Cystectomy Using Endoscopic Stapling Devices: Preliminary Experience With a Simple and Reliable Technique

We introduce a new technique to decrease operative time and blood loss during radical cystectomy. We used endoscopic stapling devices for secure hemostasis, as well as rapid division of the bladder and prostatic lateral ligaments, and the deep dorsal vein complex during radical cystectomy in 16 patients with bladder or urethral cancer compared to 11 who underwent cystectomy via a conventional method, consisting of incision and ligation with sutures. In most cases the endoscopic staplers were useful for sufficient hemostasis and rapid division of the ligaments and/or venous plexus. Mean total operative time with the stapling technique was significantly shorter than that with the standard technique (p = 0.003), and mean total blood loss was less than with the standard technique but the difference was not statistically significant. Although our study was not designed in a randomized manner, we believe that endoscopic stapling devices facilitate radical cystectomy.

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.

Novel Collagen Vascular Plug for Femoral Arteriotomy Sealing: Acute and Chronic In Vivo Studies

Background: The current use of collagen vascular hemostasis devices to percutaneously seal femoral arteriotomy sites is limited by a significant incidence of vascular complications. The purpose of the present study was to assess the efficacy of new collagen plug specifically designed to avoid these complications by accurately gauging the depth of the femoral artery and by minimizing the risk of intra‐arterial collagen deployment. Methods: The hemostasis device used in this study consists of a multicomponent collagen plug with an external rigid collagen tube lined by an inner layer of absorptive sponge collagen. Placement of this plug is facilitated with a specialized two‐lumen dilator, which localizes the arterial surface using a “bleedback” mechanism from one of the lumens, and prevents the placement of collagen through the arteriotomy site. The acute efficacy of this device was assessed in 26 adult dogs in which 36 collagen plugs were used to seal 8Fr femoral arteriotomies. An additional 16 arteriotomies treated with standard manual compression served as study controls. Following plug placement or manual compression, all puncture sites were observed for bleeding and hematoma formation over a 45‐minute period. Patency of each instrumented artery was assessed with serial femoral angiography and localization of each plug was confirmed with surgical cutdown at the puncture site. The chronic efficacy of this device was assessed in three pigs in which three collagen plugs were used to seal 8Fr femoral arteriotomies. The three animals were subsequently sacrificed at 7,14, and 30 days, respectively, for histologic analysis. Results: In acute animals, all 36 plugs were successfully placed without evidence of vascular compromise or intra‐arterial collagen deployment. In nonanticoagulated animals, hemostasis was achieved within 5 minutes in 10 of 10 plugs placed with a skin‐to‐arlery distance &gt; 1.8 cm, in 4 of 7 plugs with a skin‐to‐artery distance of 1.2–1.7 cm, and in 0 of 9 plugs with a skin‐to‐artery distance &lt; 1.2 cm. In anticoagulated animals, hemostasis within 5 minutes was demonstrated with 8 of 10 plugs with a skin‐to‐artery distance &gt; 1.8 cm; small hematomas occurred in the remaining two animals in the setting of a PTT &gt; 100 seconds. Time to hemostasis was significantly less for collagen plugs than manual compression in both nonanticoagulated animals (plug 17 ± 16 minutes; manual compression 28 ± 5 minutes; P &lt; 0.03) and anticoagulated animals (plug 6 ± 2 minutes; manual compression 42 ± 4 minutes; P &lt; 0.01). Chronic studies demonstrated femoral artery patency in all three pigs. Histologic analysis demonstrated progressive collagen resorption with no difference between collagen plug placement or manual compression at 30 days. Conclusions: The local hemostasis device utilized in this study resulted in accurate placement of a collagen plug immediately adjacent to the arteriotomy site with no evidence of acute or chronic vascular compromise or intra‐arterial collagen deposition. Hemostasis with shorter compression times than with standard manual techniques was achieved at puncture sites in which the skin‐to‐artery distance was &gt; 1.8 cm and the anticoagulation profile was not excessive. At 1 month postplacement, there is no histologic difference between plug use and standard manual compression. (J Interven Cardiol 1996;9:25–33)

Preliminary assessment of a hemoclip device for hemostasis

Preliminary assessment of a hemoclip device for hemostasis

Collagen application versus manual compression: A prospective randomized trial for arterial puncture site closure after coronary angioplasty

Objectives. This study evaluated the safety and efficacy of a newly developed puncture-sealing device consisting of subcutaneous bovine collagen application designed to facilitate local hemostasis after coronary angioplasty.Background. The most common local homostatic procedure after coronary angioplasty consists of heparin discontinuation and delayed sheath removal followed by mechanical compression at the puncture site.Methods. Between December 1991 and February 1993, 124 patients undergoing coronary angioplasty with either a 6F guiding catheter followed by a heparin infusion for > 12 h or a 7F or 8F guiding catheter with optional heparin infusion were prospectively randomized to either delayed sheath removal followed by manual compression (n = 62) or sheath removal immediately after angioplasty combined with bovine collagen application for puncture site closure (n = 62). Half of the collagen plugs were delivered using measured and half using estimated skin-artery distance. Clinical and duplex sonographic evaluations of the puncture site were performed 24 h later.Results. No significant difference in the incidence of local hematomas was observed. Major complications were false aneurysm, venous thrombosis and arterial occlusion. The incidence of false aneurysm was the same in both groups (4 [7%] of 62). Venous thrombosis (2%) and arterial occlusion (2%) were each recorded in one patient, both in the collagen application group.Conclusions. Sheath removal and collagen application with this new vascular hemostasis device used directly after coronary angioplasty are not superior to delayed sheath removal after heparin discontinuation followed by mechanical compression. Arterial collagen sealing with this device in its current form is associated with a small but worrisome risk of arterial occlusion.

Use of a mechanical pressure device for hemostasis following cardiac catheterization

Peripheral vascular complications that can occur after cardiac catheterization are costly and cause patient discomfort. To determine the difference in frequency of vascular complications in a convenience sample of cardiac catheterization patients who had mechanical pressure vs digital pressure for postprocedural hemostasis. A quasi-experimental design was used. The study group consisted of 100 patients on whom a mechanical clamp was used to effect hemostasis; the control group consisted of 100 patients who received digital pressure for hemostasis. Data from the control group were obtained retrospectively through review of cardiac catheterization charts. The two groups showed statistically significant differences for the number of catheters used, mean time elapsed between arterial entry and catheter removal, and compression time. There was no significant difference in complication rate between the groups. Complications including hematoma formation, arterial occlusion, ischemia and traumatic neuropathy were monitored. The mechanical pressure device is a safe, cost-effective alternative to digital pressure for hemostasis following cardiac catheterization. Further studies are needed to verify these results and the effectiveness of the device following other percutaneous intra-arterial procedures.

A multicenter randomized trial comparing a percutaneous collagen hemotasis device with conventional manual compression after diagnostic angiography and angioplasty

Objectives. A new percutaneous collagen hemostasis device was compared with conventional compression techniques after diagnostic catheterization and angioplasty.Background. Peripheral vascular complications diagnostic catheterization or more complex interventional procedures, as well as the discomfort of manual compression and prolonged bed rest, represent significant morbidity for invasive cardiac procedures.Methods. A prospective, multicenter, randomized trial was designed to compare the hemostasis time in minutes and the incidence of vascular complications in patients receiving a vascular hemostasis device with those undergoing conventional compression techniques.Results. After diagnostic catheterization, hemostasis time was significantly less with the vascular hemostasis device than with conventional manual compression (4.1 ± 2.8 min [n = 90 patients] vs. 17.6 ± 9.2 min [n = 75], p < 0.0001). This difference was greater in patients undergoing angioplasty and was unrelated to the anticoagulation states (4.3 ± 3.7 min [n = 71 not receiving heparin], 7.6 ± 11.6 min [n = 85 receiving heparin], 33.6 ± 24.2 min [n = 134 control patients not receiving heparin], p < 0.0001 vs. control patients). The time from the start of the procedure to ambulation was slightly less after diagnostic catheterization in patients treated with the device (13.3 ± 12.1 h vs. 19.2 ± 17.8 h, p < 0.05). It was also less in patients who underwent angioplasty when the device was used after discontinuation of anticoagulation (23.0 ± 11.1 h, without heparin), as compared with control compression techniques (32.7 ± 18.8 h, p < 0.0001). Time to ambulation was even shorter (16.1 ± 11.1 h, p < 0.0001) in patients in whom the device was placed immediately after angioplasty while they were still fully anticoagulated with a prolonged activated clotting time (336 ± 85 s). There were no major complications (surgery or transfusion) after diagnostic catheterization and a low incidence of major complications in patients who underwent angioplasty (0.7% in control patients, 1.4% with the device without heparin, 1.2% with the device and heparin, p = NS). After angioplasty, there was a trend toward fewer hematomas when the device was used in the absence of heparin (4.2% vs. 9.7% in control patients, p = 0.14).Conclusions. A new vascular hemostasis device can significantly reduce the puncture site hemostasis time and the time to ambulation without significantly increasing the risk of peripheral vascular complications. The role of this technology in reducing complications, length of hospital stay and cost remains to be determined.

Percutaneous vascular hemostasis device for interventional procedures.

A new 11.5F over-the-wire vascular hemostasis device was compared to conventional manual compression in normal swine femoral arteries. Using percutaneous techniques, the collagen was deposited and hemostasis achieved in 7 vessels after 1 minute total, plus 4 minutes partial compression, while control manual compression required more than 5 minutes total compression to avoid hematoma formation. One month follow-up of treated arteries (n = 4) and controls (n = 3) showed no impairment in distal pulse or differences in histology at the puncture site in the control and treated arteries. Thus, the vascular hemostasis device technique is safe and effective, achieves hemostasis with less compression time and complications, and does not interfere with arterial wall healing or compromise the lumen.

Initial experience with a new compression device for hemostasis after femoral arterial puncture.

We evaluated a new hemostasis device to maintain focused pressure over the femoral artery puncture site for 2-6 hours in 330 cases after diagnostic catheterization or coronary angioplasty. No patient developed later hematoma or vascular complications. The initial favorable experience suggests that this hemostasis device has advantageous features of stability and site visualization and is a suitable adjunct to current methods of maintaining puncture site pressure after brief manual compression following arterial catheterization.

First clinical evaluation and experimental study of a new mechanical suture device for endoscopic hemostasis

First clinical evaluation and experimental study of a new mechanical suture device for endoscopic hemostasis

Fibrin Foam as a Hemostatic Agent in Suprapubic Prostatectomy

OF THE many problems presented by the operation of prostatectomy none are of more importance than that of the adequate control of bleeding from the prostatic cavity after the gland has been enucleated. Whether the prostate is approached through the urethra, by way of the perineum or by the suprapubic route, this problem remains of equal importance and difficulty. The literature of prostatic surgery abounds with many methods and devices for hemostasis that need no elaboration. In general at the present such devices consist of one sort or another of catheters and elastic dilatable bags, which after distention with fluid . . .