Percutaneous Application of Fibrin Sealant to Achieve Hemostasis Following Arterial Catheterization.

OBJECTIVES: The present study sought to investigate the safety and efficacy of a new fibrin sealant using percutaneous delivery techniques. BACKGROUND: The femoral approach has become the preferred means of access for percutaneous diagnostic and interventional procedures. Control of access site bleeding following catheterization, however, remains a significant problem in interventional cardiology. METHODS: Adult mongrel dogs were used in this study. Series 1 compared the effectiveness of fibrin sealant vs. manual compression alone in the presence of anticoagulants, thrombolytic, and antiplatelet agents. Series 2 assessed fibrin sealant safety. Series 3 examined fibrin sealant performance under elevated blood pressure levels. RESULTS: Series 1: Hemostasis was achieved in all fibrin sealant sites in significantly less time (8.5 +/- 4.3 min) with no major complications compared to manual compression sites (65.2 +/- 19.3 min) accompanied by serious complications. For all adjunctive agents employed, hemostasis was achieved in fibrin sealant sites in significantly less time (warfarin 9.9 +/-.2, urokinase 11.2 +/- 5.6, ReoProª 10.5 +/- 6.3 min) than for manual compression sites (warfarin 86.5 +/- 21.4, urokinase 89.8 +/- 36.3, ReoPro 77.9 +/- 26.5 min). Series 2: I25 iodine-labeled fibrinogen sealant was applied to puncture sites with no traces of circulating radioactivity observed over a one-hour period. Series 3: hemostasis was achieved under elevated blood pressure conditions in all animals. Histologic studies showed complete re-absorption of fibrin sealant 28 days post-procedure with no evidence of foreign body reaction. CONCLUSIONS: Percutaneous application of fibrin sealant to achieve hemostasis following catheterization appears to be a simple, safe, and highly effective procedure in a canine model.

Long- and short-term effects of transmyocardial laser revascularization in acute myocardial ischemia.

BACKGROUND AND OBJECTIVE: This study examined the effect of transmyocardial laser revascularization (TMLR) on infarct size and global and regional left ventricular (LV) function. STUDY DESIGN/MATERIALS AND METHODS: Acute ischemia was induced in 24 dogs by ligating the left anterior descending artery. TMLR was done through a left thoracotomy in 12 dogs. The 12 control dogs had ligation only. Global and regional LV function were measured before ligation, then at 6 hours or 3 months after ligation. We calculated the volumetric ratio of damaged myocardium to myocardium at risk (Vd/Vr). RESULTS: At 6 hours, global compensation despite regional dyskinesia was universal; Vd/Vr was the same in control and TMLR dogs. At 3 months, global function during stress was significantly higher in TMLR dogs than in control dogs (P < .05); regional contractions were synergic only in TMLR dogs; mean Vd/Vr was significantly lower in TMLR dogs. CONCLUSION: TMLR limits infarct expansion and improves long-term global and regional function after acute ischemia.

Five month survival in a calf supported with an intraventricular axial flow blood pump.

We are studying in vivo an intraventricular axial flow blood pump (Jarvik 2000) designed for long-term left ventricular support. The small (25 cc, 85 g) valveless pump has been placed intraventricularly in seven calves; pumps have functioned for as long as 5 months. In the four most recent long-term studies completed, calves have survived for 70, 120, 155, and 162 days (in that order); weight gain has averaged 0.56 kg/day. One study is ongoing at more than 30 days. Under resting physiologic conditions in the normal calf, the continuous flow pump produces flows of 5-6 L/min with a decreased arterial pulse contour. The device has caused no physiologic complications. Calves in the completed studies had mean free plasma hemoglobin levels of 11.4, 7.1, 6.5, and 4.3 mg/dl, respectively. We have modified the inflow structures of the device, and these results suggest that a thrombus free design with no pannus at or around the inlet of the pump can be achieved. Histopathologic analyses of the heart and kidneys in studies of as long as 5 months show no deleterious effects of this device. These studies demonstrate the feasibility of a small implanted intraventricular blood pump for long-term use. Future developments for permanent implantation will include implanted physiologic control systems, transcutaneous energy transmission systems, and implanted batteries.

Hospital charges for conventional therapy versus left ventricular assist system therapy in heart transplant patients.

An important goal of a left ventricular assist system (LVAS) is to provide long-term, safe, cost-effective mechanical circulatory support. The Heartmate LVAS (Thermo Cardiosystems, Inc., Woburn, MA), used in recent clinical trials as a bridge to transplantation, has proven extremely reliable for long periods, and its use has improved the survival rates in patients who subsequently received a donor heart. Patients who have been implanted with an LVAS often have significantly improved physical status and can leave the intensive care unit (ICU) and be treated at less expense elsewhere in the hospital. In this preliminary report, the authors analyzed hospital charges for three groups of patients: heart transplant patients who received conventional medical therapy before transplantation (Group 1), transplant patients who received in-hospital LVAS therapy (Group 2), and one patient who awaited transplantation at home while undergoing LVAS support. Group 1 patients (n = 6) received intraaortic balloon pump (IABP) support and inotropic therapy in an ICU before transplantation. Group 2 (n = 6) patients were receiving IABP support and inotropic therapy when the LVAS was implanted and eventually underwent heart transplantation. The length of hospital stay in Group 1 (51 days) was significantly shorter than in Group 2 (185 days). Mean hospital charge in Group 1 was $5,150/day; in Group 2, $3,178/day. The patient living at home incurred an average medical expense of $27/day. Although LVAS supported patients remain in the hospital much longer than do medically treated patients, their average daily in-hospital charges are much less. If the LVAS could be used as an alternative to transplantation, it might offer not only a longer, better quality life, but also a potential cost savings to patients with end-stage heart failure.

Use of a left ventricular assist device in an outpatient setting.

The vented electric Heartmate LVAD (VE-LVAD) (Thermo Cardiosystems, Inc., Woburn, MA) is a reliable, fully portable system that allows selected patients with end-stage cardiomyopathy to undergo outpatient treatment while waiting for heart transplantation. This implantable, pusher-plate LVAD is actuated by an electric motor located within the pump housing. The patient wears external batteries and a system controller, which power and control the LVAD motor through a percutaneous lead. Since May 1991, four men have been supported with the VE-LVAD. They ranged in age from 33 to 50 years (mean, 44.3 years); two had idiopathic cardiomyopathy, and two had ischemic cardiomyopathy. Of the four patients, three underwent support of 196, 219, and 504 days; support in the fourth patient is ongoing at more than 90 days. All four patients were fully rehabilitated to New York Heart Association Class I status. Because they were well and fully mobile, the protocol was amended to allow these patients to leave the hospital in a four phase program that begins with 16 hr day passes and leads to hospital discharge. When patients leave the hospital, they are accompanied by trained family members or friends. The patients who have participated in the program have performed routine activities, attended social events, and spent the night at home. The VE-LVAD system seems safe and appropriate for the outpatient setting in selected patients. Patients have been able to manage the system without assistance from medical or engineering personnel. This initial positive experience with outpatient LVAD treatment demonstrates the potential for providing long-term cardiac support with this type of implantable technology.