Reverse endoventricular artificial obturator in tricuspid valve position. Experimental feasibility research study.

The concept of vena contracta space reduction in tricuspid valve position was tested in an animal model. Feasibility of specific artificial obturator body (REMOT) fixed to the right ventricular apex and interacting with tricuspid valve leaflets was evaluated in three different animal studies. Catheter-based technique was used in three series of experiment in 7 sheep. First acute study was designed for evaluation if the screwing mode of guide wire anchoring to the right ventricular apex is feasible for the whole REMOT body fixing. Longer study was aimed to evaluate stability of the REMOT body in desired position when fixing the screwing wire on its both ends (to the right ventricular apex and to the skin in the neck area). X-ray methods and various morphological methods were used. The third acute study was intended to the REMOT body deployment without any fixing wire. In all of 7 sheep the REMOT was successfully inserted into the right heart cavities and then fixed to the right ventricular apex area. When the REMOT was left in situ more than 6 months it was stable, induced adhesion to the tricuspid valve leaflet and was associated with a specific cell invasion. Releasing of the REMOT from the guiding tools was also successfully verified. Deployment of the obturator body in the aim to reduce the tricuspid valve orifice is feasible and well tolerated in the short and longer term animal model. Specific cell colonization including neovascularization of the obturator body was observed.

Small intestinal submucosa sandwich Zilver stent-grafts for TIPS: experimental pilot study in swine.

The aim of this study was the evaluation of preliminary suitability of the piglet small intestinal submucosa (SIS) sandwich Zilver endograft for experimental transjugular intrahepatic portosystemic shunt (TIPS) creation. TIPS was created in six swine. The five surviving animals underwent the follow-up portogram and were sacrificed at four weeks after TIPS creation. Gross and histologic examination was performed in all animals. TIPS creation was successful in all animals. One animal died four days after TIPS creation. In the five surviving animals, one shunt was occluded and four shunts were stenosed on the follow-up portogram. The mean percentage narrowing of the most advanced stenoses was 72% (range, 60%-100%). The most advanced stenosis was located in the parenchymal tract in three shunts and in the hepatic vein portion in one shunt. Gross and histologic examination showed abundant neointimal formation composed mainly of fibroblasts leading to the significant shunt stenoses. The piglet SIS sandwich Zilver stent-graft was found to offer only limited TIPS patency and should not be used for the definitive long-term TIPS study.

Late complications and shape changes of the endografts after gigantic thoracic aortic aneurysm repair over a 7-year follow-up.

This report details a 7 years follow up observations in a 71-year-old patient treated with custom made endograft for gigantic thoracic aortic aneurysm (TAA). Progressive changes of the thoracic aorta and aneurysm after endograft placement led to two late complications including proximal stent graft prolapse into the aneurysm and extreme kinking of the endograft and aorta 28 and 51 months after treatment, respectively. Both complications were successfully treated with new endografts placement. Percutaneous endovascular repair is a promising, minimally invasive alternative to exclude TAA. This technique allows long-term treatment of patients who are unsuitable for conventional surgical procedures.

Progesterone regulation of vascular thromboxane A(2) receptors in rhesus monkeys.

We hypothesized that progesterone regulates thromboxane A(2) receptor (TxA(2)R) density in primate vascular muscle and that TxA(2)R density correlates with coronary reactivity in vivo and in vitro. Reactivity to serotonin + U-46619 was determined by angiography in surgically postmenopausal [ovariectomized (Ovx)] rhesus monkeys without progesterone replacement and after 2-wk progesterone treatment (1-2 ng/ml). In untreated Ovx animals, 100 micromol/l serotonin + 1 micromol/l U-46619 (syringe concentrations) provoked vasospasm-like constrictions in six of six monkeys; zero of six progesterone-treated monkeys developed vasospasms. Sustained Ca(2+) responses in vascular muscle cells isolated from Ovx coronaries (208 +/- 63% of basal 20 min after stimulation) treated with serotonin + U-46619 contrasted with transient Ca(2+) responses (143 +/- 18% of basal and decreasing 5 min after stimulation) in progesterone-treated monkeys. The maximum density of [1S-(1I,2J(5Z),3I(1E,3R*),4I)]-7-[3-(3-hydroxy-4-(4'-[(125)I]iodophenoxy)- 1-butenyl)-7-oxabicyclo[2.2.1]heptan-2-yl]-5-heptenoic acid ([(125)I]-BOP) binding was greater (P < 0.01) in carotid arteries and aortic membranes from Ovx (109 +/- 11 fmol/mg) compared with progesterone-treated (43 +/- 15 fmol/mg) monkeys. TxA(2)R immunolabeling revealed greater coronary TxA(2)R labeling in Ovx compared with progesterone-treated monkeys. The results suggest that progesterone can decrease arterial TxA(2)R in Ovx monkeys.

Endoluminal treatment of ruptured abdominal aortic aneurysm with small intestinal submucosa sandwich endografts: a pilot study in sheep.

PURPOSE: To evaluate efficacy of small intestinal submucosa (SIS) Sandwich endografts for the treatment of acute rupture of abdominal aortic aneurysms (AAA) and to explore the short-term reaction of the aorta to this material. METHODS: In eight adult sheep, an infrarenal AAA was created transluminally by dilation of a short Palmaz stent. In six sheep, the aneurysm was then ruptured by overdilation of the stent with a large angioplasty balloon. Two sheep with AAAs that were not ruptured served as controls. A SIS Sandwich endograft, consisting of a Z stent frame with 5 bodies and covered inside and out with SIS, was used to exclude the ruptured and non-ruptured AAAs. Follow-up aortography was done immediately after the procedure and before sacrifice at 4, 8, or 12 weeks. Autopsy and histologic studies followed. RESULTS: Endograft placement was successful in all eight sheep. Both ruptured and non-ruptured AAAs were successfully excluded. Three animals with AAA rupture developed hind leg paralysis due to compromise of the arterial supply to the lower spinal cord and were sacrificed 1 day after the procedure. In five animals, three with rupture and two controls, follow-up aortograms revealed no aortic stenoses and no perigraft leaks. Gross and histologic studies revealed incorporation of the endografts into the aortic wall with replacement of SIS by dense neointima that was completely endothelialized in areas where the endograft was in direct contact with the aortic wall. In central portions of the endograft, in contact with the thrombosed aneurysm, endothelialization was incomplete even at 12 weeks. CONCLUSION: The SIS Sandwich endografts effectively excluded simple AAAs and ruptured AAAs. They were rapidly incorporated into the aortic wall. A detailed long-term study is warranted.

Bifurcated drum occluder endograft for treatment of abdominal aortic aneurysm: an experimental study in dogs.

PURPOSE: To evaluate a new, low profile, home-made, bifurcated drum occluder endograft (BDOEG), designed for percutaneous, transcatheter treatment of abdominal aortic aneurysm (AAA). MATERIALS AND METHODS: AAA was created in 10 dogs with over-dilated Palmaz stents. To prevent back filling, the lumbar arteries, inferior mesenteric artery, and common internal iliac arteries were embolized. The BDOEG was constructed of a drum occluder device and two PTFE endografts. The drum device consisted of a modified Z stent with Dacron stretched across and held within the ends of the stent, each with two 8 x 6-mm slits through which PTFE endografts were delivered. The PTFE endografts were 8 mm in diameter and 9.5 cm in length. Preloaded, the BDOEG was delivered through a 10-F sheath from both femoral arteries in a three-step procedure. All 10 animals were treated with BDOEG. Aortography was performed immediately, 6 weeks, and 12 weeks after stent-graft placement. Five animals were killed at 6 weeks and five were killed at 3 months. Gross and histologic evaluation was performed. RESULTS: The infrarenal aortic diameters and both external iliac arteries ranged from 8.0 mm to 10.3 mm (mean, 9.4 mm +/- 0.6) and from 5.2 mm to 6.8 mm (mean, 5.8 mm +/- 0.5), respectively. Creation of the AAA was successful in all 10 dogs. AAA diameters ranged from 13.7 mm to 15.9 mm (mean, 14.9 mm +/- 0.7). Complete exclusion of the AAA was achieved immediately after BDOEG placement and aneurysms remained excluded without perigraft leak to the time of killing in all 10 animals. There was a high incidence of aortoiliac limb occlusion. Occlusion of 12 aortoiliac limbs (60%) caused by intimal hyperplasia at the distal end of the endografts in iliac arteries developed in nine animals (90%). In six animals (60%), one limb occluded and, in three animals (30%), there was occlusion of both limbs. CONCLUSION: This study suggests a new approach for treatment of AAA. BDOEG use reduces sheath size for endograft delivery and may eliminate the need for a surgical cut down on femoral arteries. Tapering of the iliac ends of endografts to the size of the artery will be needed to prevent distal intimal hyperplasia.

Effects of intraarterial thrombin in the swine model.

PURPOSE: To evaluate the effects of catheter-directed thrombin in the peripheral arterial circulation of swine. MATERIALS AND METHODS: Thrombin was injected into a single femoral artery in 20 domestic swine. Each of five animals from four dose groups received 50, 150, 250, or 1,000 U as a single dose. Bilateral femoral arterial flow was monitored for as long as 4 hours and evaluated relative to baseline and contralateral limb flow. Interval arteriographic results were evaluated by segmental patency and a numeric angiographic score. RESULTS: Mean baseline flow was 136 mL/min +/- 44, with an internal arterial diameter of 3.4 mm +/- 0.5. A transient increase in blood flow after thrombin administration was followed by diminished flow and thrombosis. These findings varied directly with dose and inversely with baseline flow. Angiographic and flow abnormalities generally improved with time and recovery was generally better in swine that received 50 or 1,000 U than in other groups. However, one animal that received 1,000 U (13.2 U/mL/min) developed stable, complete limb thrombosis. The degree of recovery varied with thrombin dose and thrombus location. At doses greater than 50 U (0.33 U/mL/min +/- 0.05), abnormalities were commonly persistent. Animals receiving the 150-U dose (1.33 U/mL/min +/- 0.41) had a higher incidence of persistent distal occlusion. Distal occlusions were less likely to resolve than proximal occlusions. CONCLUSIONS: The effect of intraarterial thrombin is directly related to dose and inversely related to baseline blood flow. In swine, a threshold for significant flow disruption and thrombosis exists above a dose of 50 U (0.33 U/mL/min +/- 0.05). A threshold dose for irreversible occlusion may also exist. Although small amounts of thrombin in a high-flow vessel may not cause significant complication, administration into the arterial circulation should be avoided.

The cutting pericardiotome: another option for pericardiopleural draining in recurrent pericardial effusion. Initial experience.

Large recurrent pericardial effusion can be managed by repeat pericardiocentesis or by surgery. A relatively new, catheter-based method uses a balloon catheter (percutaneous balloon pericardiotomy) for drainage from the pericardial sac to the pleural space. As an alternative, we present a newly developed device: Cutting pericardiotome.

Square stent: a new self-expandable endoluminal device and its applications.

The square stent is a new, simply constructed, self-expanding device that has recently been described. Compared with other stents, the square stent has a minimal amount of metal and thus requires a smaller-diameter catheter for introduction. Despite the small amount of metal present, the square stent has adequate expansile force. We have been evaluating the square stent for various interventional applications. In addition to the basic square stent, combinations of square stents and coverings for square stents were developed and evaluated to expand its uses and indications. One of the coverings tested is a new biomaterial: small intestinal submucosa (SIS). This paper will discuss the various applications of the square stent, which include a retrievable inferior vena cava filter, vascular occluder, graft adapter, and venous and aortic valves. In addition, we will review the important properties of SIS as a covering for the square stent.

Small intestinal submucosa covered expandable Z stents for treatment of tracheal injury: an experimental pilot study in swine.

PURPOSE: To evaluate efficacy of small intestinal submucosa (SIS) as a stent covering in healing experimentally created tracheal defects and to explore the trachea's reaction to placement of SIS-covered stents. MATERIAL AND METHODS: A tracheal defect with a diameter of approximately 10 mm was created in six swine with use of a blade or electrocauterization. A double-body, self-expandable SIS-covered Gianturco Rösch Z stent was placed into the trachea to cover the defect. The animals were observed, and were killed when they developed respiratory problems. Autopsy and histologic studies were performed. RESULTS: The SIS-covered stents were accurately placed without immediate complications related to placement. All animals developed respiratory problems on follow-up. One animal died 9 days after procedure because of pneumonia, the others five were killed at 12, 17, 18, 28, and 56 days because of stridor, wheezing, and cough. At autopsy and histology, the tracheal defects were found to be completely healed, with epithelial lining and regeneration of submucosal glands. Animals whose defects were created with a blade demonstrated cartilage remodeling between 9 and 18 days, and apparent deposition of new cartilage at 28 days after SIS placement. The defects made by electrocauterization showed only fibrous tissue with no cartilage regeneration. The tracheal lumen was narrowed by overgrowth of granulation tissue, particularly at the end wires of the stents. In three animals, polypoid masses caused 60%, 70%, and 80% tracheal obstruction, respectively. CONCLUSION: Placement of SIS-covered stents contributed to rapid and effective healing of large tracheal defects. Rigidity and oversizing of Gianturco Rösch Z stents led to secondary changes of the tracheal wall, causing significant airway obstructions. Smaller size and flexible stents should be selected for future work.

Percutaneous transcatheter aortic disc valve prosthesis implantation: a feasibility study.

PURPOSE: Over the past 30 years there have been experimental efforts at catheter-based management of aortic valve regurgitation with the idea of extending treatment to nonsurgical candidates. A new catheter-based aortic valve design is described. METHODS: The new catheter-delivered valve consists of a stent-based valve cage with locking mechanism and a prosthetic flexible tilting valve disc. The valve cage is delivered first followed by deployment and locking of the disc. In acute experiments, valve implantation was done in four dogs. RESULTS: Valve implantation was successful in all four animals. The implanted valve functioned well for the duration of the experiments (up to 3 hr). CONCLUSION: The study showed the implantation feasibility and short-term function of the tested catheter-based aortic disc valve. Further experimental studies are warranted.

The square stent-based large vessel occluder: an experimental pilot study.

PURPOSE: The purpose of this study is in vitro and in vivo experimental evaluation of a square stent-based vascular occlusion device for large vessels. MATERIALS AND METHODS: Square stent-based large vessel occluders (LVO) 5 mm-50 mm in size were constructed from stainless-steel square stents covered by porcine small intestine submucosa (SIS). The LVOs with two back-side barbs were delivered through a guiding catheter. The LVOs with two back-side barbs and two frontal barbs were front-loaded and delivered coaxially. A pusher with a retention mechanism at its end was used for deployment. In vitro testing for competency was performed with use of a flow model with pressure increases. In an experimental pilot study in seven pigs and five dogs, 16 LVOs were placed into the aorta (n = 4), common iliac artery (n = 2), pulmonary artery (n = 4), and medial sacral artery (n = 6). Four animals received two LVOs in different locations. Angiography was performed before and after placement of each LVO. Animals were followed for as long as 3 months with use of angiography and were then killed for gross and histologic evaluation. RESULTS: In vitro LVOs with two and four barbs were easily collapsed and pushed through or front-loaded into guiding catheters (6-F for a 5-mm occluder, 10-F for a 50-mm occluder). A 20-mm LVO adapted to tubular structures 10-15 mm in diameter, forming polygons 17-18.5 mm in length. In the flow model, LVOs endured pressure increases to 300 mm Hg. In vivo, the LVOs self-expanded and adapted to the vessel without migration in all cases. The locking pusher allowed precise LVO placement and engagement of its barbs into the vessel wall before complete deployment, preventing dislodgment by blood flow. Complete arterial occlusion occurred within 10-20 minutes and arteries remained occluded until the animal was killed in all cases. After 2 months, histologic evaluation revealed replacement of SIS by host tissue and its remodeling with variable fibrocytes, fibroblasts, and some inflammatory cells. Complete endothelialization was seen on both sides of the LVO. CONCLUSION: The SIS LVO is effective and reliable for acute and chronic occlusion in a high flow model in an experimental animal.

Autologous vein stent-graft: feasibility study.

PURPOSE: To evaluate expandable stents healed into vein wall as autologous vein stent-grafts for endoluminal grafting. MATERIALS AND METHODS: Balloon expandable stents were placed into external jugular veins of eight dogs. Stent and vein patency was followed by ultrasonography. Five weeks after stent placement, jugular veins with endothelialized stent were harvested. The autologous vein stent-grafts were divided into two groups. In group A, autologous vein stent-grafts (n = 3) were placed immediately into Baker solution for microscopic examination. In group B, autologous vein stent-grafts (n = 3) underwent mechanical manipulation; they were compressed, mounted on angioplasty balloon, pushed through a 9-F sheath and dilated. The autologous vein stent-graft endothelialization and changes after mechanical manipulation were evaluated by light and electron microscopy. RESULTS: Stent placement was successful in seven dogs. One stent migrated into the pulmonary artery. One well placed stent was damaged by compression dressing and thrombosed. At 5 weeks, gross and microscopic examinations revealed the autologous vein stent-grafts were fully covered by a 0.115- +/- 0.036-mm-thick neointimal layer. Small wall thrombus was observed in one autologous vein stent-graft. Repeated manipulations did not result in any intimal damage or stent loosening in the autologous vein stent-grafts. CONCLUSION: Expandable stents healed into a vein have potential to be used as autologous vein stent-grafts for endoluminal grafting without risk of disruption during percutaneous transcatheter introduction.

Aortic and venous valve for percutaneous insertion.

The purpose of this paper is to present in vitro and in vivo experimental evaluation of a new, artificial, bicuspid, aortic and venous valve. Valves were constructed from square stents with barbs covered by porcine small intestine submucosa (SIS). A valve 15 mm in diameter was tested in a flow model (2.5 l/min) with pressure measurement. A 100-ml rubber bag attached to a side arm of the flow model simulated heart ejection fraction. In acute (n=6) and short-term (n=3) experiments conducted in four swine and four dogs, valves ranging from 16-28 mm in diameter were placed into the ascending aorta through 10 F sheaths; three were placed subcoronary and six in a supracoronary position. Function and stability of the valves were studied with pressure measurements and aortograms. Three short-term animals were sacrificed for gross and histologic evaluation at one, two and four weeks respectively. In an acute experiment, venous valves with four barbs were placed into the IVC through an 8 F guiding catheter in three dogs. For longer-term testing, valves were placed into the IVCs and iliac veins of three young swine. The animals were followed up after two weeks with venograms, then were sacrificed for gross and histologic evaluation.

Percutaneous transjugular kidney biopsy in swine with use of a side-cutting needle with a blunt-tipped stylet.

PURPOSE: To evaluate a new 19-gauge blunt-tipped, side-cutting, single throw transjugular biopsy needle for transvenous kidney biopsies. MATERIALS AND METHODS: Transjugular transvenous kidney biopsies were performed with a modified 70-cm biopsy needle utilizing fluoroscopic guidance in nine swine. Three tissue specimens were obtained with four biopsy device passes in five animals and three biopsy device passes in four animals. Renal arteriography and venography were performed immediately before and after renal biopsy. Five animals were killed immediately after biopsy. Four animals were allowed to recover and underwent arteriography and venography prior to being killed, which varied from 1 to 6 weeks. Gross and histologic examinations of the biopsied kidney were performed after euthanasia. A pathologist reviewed all biopsy specimens for quality based on the number of glomeruli present. RESULTS: Results of immediate and delayed arteriography and venography were normal in all cases. Histologic evaluation of all biopsy specimens demonstrated a range of two to 13 glomeruli per sample (mean, 6.5), with successful acquisition of the cortex. In one animal killed immediately after biopsy, a small subcapsular hematoma was present. CONCLUSION: The 19-gauge, side-cut biopsy needle with a blunt-tip stylet proved to be efficacious for obtaining renal cortical samples in right swine kidneys via a transjugular approach.

Twin-tube endografts for aortic aneurysms: an experimental feasibility study.

PURPOSE: To explore feasibility of twin-tube endografts (TTEGs) for treatment of abdominal aortic aneurysm (AAA). MATERIALS AND METHODS: AAAs were created in six dogs by overdilation of Palmaz stents. TTEGs made of seven 9.5-mm-diameter Gianturco Rösch Z (GRZ) stents and covered with PTFE were deployed simultaneously from both femoral arteries through 10-F sheaths to exclude the AAA. Follow-up aortography was performed immediately and at 2, 4, and 8 weeks. Two dogs were killed at 4 weeks and four were killed at 8 weeks. Gross and histologic examinations were performed. RESULTS: AAA creation and TTEG placement were successful in all six dogs. TTEGs completely excluded AAAs in five dogs. Minor temporary perigraft leak was seen in one dog immediately after stent placement. Four dogs had TTEGs patent to termination at 8 weeks. In two dogs with oversized TTEGs, one of the twin endografts occluded at 2 weeks. At autopsy, TTEGs were formed in semicircular shape and histology did not show any significant inflammatory reaction. CONCLUSION: TTEGs show promise for treatment of AAA, with the potential of reducing the introductory sheath size. Further experimental studies, particularly with TTEGs extended into iliac arteries, are warranted.

Retrievable IVC square stent filter: experimental study.

PURPOSE: In vitro and in vivo evaluation of a new retrievable, home-made, inferior vena cava (IVC) Square stent filter (SSF) with two trapping levels. METHODS: In vitro, the SSF was compared in a flow model with the stainless steel Greenfield filter (SGF) for emboli-trapping efficiency by serially passing 300 emboli of 3 and 6 mm in diameter and 15-30 mm in length in each type of filter. Nine swine were used for the in vivo testing of the SSF for deployment and retrievability, emboli-trapping efficiency, stability, and self-centering ability and two were used (total of 11 swine) for testing repositioning and retrievability of the SSF at 2 weeks and for gross and histologic IVC changes at 2 months. RESULTS: In vitro, the SSF and SGF had similar efficiency in trapping large emboli but the SSF had significantly better efficiency than the SGF for trapping all sizes of emboli (91.7% vs 81%), medium size emboli (93% vs 80%), and small emboli (86% vs 69%). Efficiency decreased in both filters from the first to the fifth embolus in each series but was still significantly better for the SSF. With the SSF, 89% of emboli were caught at the primary and 11% at the secondary filtration level. In the nine animals used for acute studies, the SSF was easily placed in all 27 attempts, assumed a central position 26 times, and was easily retrieved in 21 of 22 attempts. One tilted filter needed additional manipulation for retrieval. During emboli injection in five swine, the SSF had 97.2% emboli-trapping efficiency and demonstrated good stability. In the two animals used for longer-term evaluation, the filters were easily retrieved 2 weeks after implantation. Histologic evaluation at 2 months showed neointimal proliferation around the SSF wires in contact with the IVC wall, which was otherwise normal. CONCLUSION: The SSF is a promising filter. It is easy to place and retrieve, is stable after placement, and has high efficiency for trapping emboli. Promising results justify further experimental and eventual clinical studies with a commercially manufactured SSF.

Polyurethane-coated Dacron-covered stent-grafts for TIPS: results in swine.

PURPOSE: To evaluate shunt patency after placing a new polyurethane-coated Dacron-covered spiral Z stent-graft to create a transjugular intrahepatic portosystemic shunt (TIPS). METHODS: TIPS stent-grafts were placed in six young swine, using polyurethane-coated, Dacron-covered spiral Z stent-grafts. Animals were followed weekly by transhepatic portal venography until shunt occlusion or up to 6 weeks, then were sacrificed for gross and histologic evaluation. RESULTS: Five of six TIPS stent-grafts were found to be occluded by 3 weeks and none were patent at 6 weeks. Histologic evaluation demonstrated a marked foreign body reaction with superimposed thrombosis occluding the graft lumen. CONCLUSION: Polyurethane-coated Dacron-covered stent-grafts do not improve TIPS patency.

Idiopathic enlargement of the right atrium.

A case of aneurysmal enlargement of the right atrium was found accidentally during a routine examination. The patient was asymptomatic and free of palpitations or proven rhythm disturbances. The results of echocardiography, magnetic resonance imaging, and cardiac catheterization excluded cardiac malformation, which could have caused secondary enlargement of the right atrium. A partial pericardial defect as a likely cause of herniation of the right atrium was ruled out by magnetic resonance imaging. In keeping with these results, isolated aneurysmal enlargement of the right atrium was diagnosed.