Phasic coronary blood flow patterns in dogs vs. pigs: an acute ischemic heart study.

BACKGROUND: Canine and porcine hearts have been widely used to investigate diagnoses, interventions, and surgical therapies for ischemic heart disease. Dogs and pigs are known to vary with regard to the anatomic distribution of their coronary arteries. However, the mechanisms of these differences and the differing phasic coronary blood flow patterns between the two species are not well characterized. MATERIAL/METHODS: Phasic coronary blood flow patterns and hemodynamic data were analyzed using three flow probes placed around the left anterior descending (LAD), left circumflex (LCX), and right coronary (RCA) arteries in both canine and porcine models. RESULTS: Systolic left ventricular pressure, arterial pressure, and systemic vascular resistance in dogs were higher than in pigs. Likewise, total coronary blood flow, LAD flow, and LCX flow were higher in dogs than in pigs. LCX flow was higher in dogs, but RCA flow was higher in pigs. Diastolic fraction and diastolic/systolic peak velocity ratio of the LAD, LCX, and RCA showed no significant differences at baseline between dogs and pigs. Systolic LAD flow in dogs decreased after the creation of an LAD stenosis, whereas systolic LAD flow in pigs increased. CONCLUSIONS: Coronary blood flow patterns in dogs and pigs are quite different. These findings are potentially relevant to understanding the physiology of myocardial blood perfusion in dogs and pigs with ischemic heart disease.

Transmural distribution of myocardial blood perfusion and phasic coronary blood flow pattern in a canine model of acute ischemia.

BACKGROUND: Although several investigators have analyzed coronary artery blood flow under various conditions, almost all these studies have measured only some branches of the left anterior descending (LAD), left circumflex (LCX), or right coronary (RCA) artery. METHODS: In a canine model of acute ischemia (n = 5), we simultaneously assessed (a) regional myocardial blood perfusion using microspheres and (b) phasic coronary blood flow patterns as measured by three epicardial flow probes placed around the LAD, LCX, and RCA. RESULTS: The results from this study indicated that the LAD supplies blood to the epicardial (r = 0.687, p<0.0001), midwall (r = 0.556, p = 0.0021), and endocardial layers (r = 0.666, p = 0.0001) of the LAD area; the LCX supplies the midwall (r = 0.514, p = 0.0051) and endocardial layer (r = 0.621, p = 0.0004) of the LCX area, antero-lateral papillary muscle (r = 0.548, p = 0.0025), and postero-medial papillary muscle (r = 0.641, p = 0.0002), especially during the diastolic phase; and the RCA supplies the right ventricular apex (r=0.559, p=0.0020), left atrium (r = 0.618, p = 0.0005), right atrium (r = 0.471, p = 0.0114), and postero-medial papillary muscle (r = 0.486, p = 0.0088), especially during the systolic phase. CONCLUSIONS: These results are potentially relevant to understanding the physiology of myocardial blood perfusion and to improving treatment of acute myocardial ischemia and infarction.

Experimental study of new diagnostic system for coronary artery disease using coronary transit index.

OBJECTIVES: Noninvasive cardiac imaging techniques have had an increasing role in the diagnosis of coronary artery disease. However, these techniques are not widely available as a tool in the office setting. The purpose of this study was to provide an accurate assessment of coronary artery disease for screening purposes using Coronary Transit Index (CTI) assessment with small, high-resolution gamma cameras. METHODS: Total coronary blood flow was measured with ultrasonic flow probes placed around the left anterior descending coronary artery, left circumflex coronary artery, and right coronary artery in a total of 33 conditions in 5 healthy mongrel dogs. The coronary blood flow was reduced stepwise with vascular occluders placed around the coronary arteries. The procedure for obtaining CTI included 4 parts: 1) The animal was injected intravenously with a bolus of a radioactive tracer (2.5-5.0 mCi of (99m)Tc-DTPA); 2) Dedicated gamma sensors monitored the passage of the injected bolus; 3) Time-activity curves were measured at the left ventricle with and without its wall; 4) The ratio of the washout rates of the 2 curves determined the CTI. RESULTS: Coronary Transit Index was successfully obtained from the left ventricle. The coronary blood flows measured by flow probes were well correlated with the regional myocardial blood flow. The percentage of the baseline value of the total coronary blood flow had the highest correlation (R=0.807, p<0.0001) with the Coronary Transit Index. CONCLUSIONS: These data indicated that a new diagnostic system using CTI successfully identified reduced coronary blood flow.

Development of patient-specific three-dimensional pediatric cardiac models.

The availability of algorithms to create three-dimensional (3D) models from medical images has made it possible to render and build patient-specific reconstructions of individual body parts. In the present study, this technology was used to create 3D models of pediatric hearts for use in medical device development. Digital models were created using CT datasets of pediatric hearts and commercially available 3D image processing software. Using this software, stacked CT data were viewed, and pixels representing the heart and rib cage were selected and rendered as 3D models. Stereolithography and 3D printing technology were used to create rigid and flexible physical heart models (biomodels) from the digital models. Twelve on-screen models of the thorax and cardiac structures were created from cardiac CT scans obtained from 11 patients with and without congenital heart disease (median age, 3 years; range, 2 days to 13 years). Rigid and flexible physical heart models were generated from the digital models to provide tactile and visual information. 3D models of pediatric cardiac and chest anatomy provide enhanced understanding and tactile representation of complex anatomy. Precise representation of the spatial relationships between anatomic structures is particularly useful during the development and placement of medical devices.

The PediPump: development status of a new pediatric ventricular assist device: update II.

The PediPump is a new ventricular assist device with a hydraulic output range designed for children from newborn infants to adolescents. The design is based on a mixed-flow rotary pump; the rotating assembly consists of a front impeller, front and rear radial magnetic bearings, and a central motor magnet. Two different implantable pumps were designed initially: an intravascular pump measuring 7 x 75 mm and an extravascular pump measuring 14 x 85 mm. Current prototypes are substantially smaller: The current intravascular version measures 4.5 x 55 mm, whereas the current extravascular version measures 11 x 70 mm. Both devices provide pressure and flows capable of supporting adults, far exceeding the initially defined physiologic requirements for children weighing 2 to 25 kg. This basic pump design may be used in acute or chronic clinical settings to provide right ventricular, left ventricular, or biventricular support. There are three objectives for the PediPump development program: 1) determination of basic engineering requirements for hardware and control logic including design analysis for system sizing, evaluation of control concepts, and bench testing of prototypes; 2) performance of preclinical anatomic fitting studies using CT-based 3D modeling; and 3) animal studies to provide characterization and reliability testing of the device.

Replacement of the left-side valves of an implanted total artificial heart.

The MagScrew total artificial heart (TAH) is under development. Despite its anticipated durability and reliability, the possibility of a bioprosthetic valve malfunction exists. As a result, the potential for valve replacement surgery, instead of device replacement, would be desirable after a TAH implant. In two of our 90-day animal experiments, we successfully replaced the left-side valves through a left thoracotomy opposite to the right-sided incision site for the initial TAH implant. The results of these cases suggest that the left-side valves could also be replaced through a left thoracotomy approach in humans. To confirm the ability to access the left-side valves in humans, four human cadaver studies were performed with the use of a mock pump designed for human application. This report describes the operative techniques for left-side valve replacement in animals and discusses the advantages of a left thoracotomy in clinical situations, based on results from the human cadaver studies.

A novel technique for functional mitral regurgitation therapy: mitral annular remodeling.

BACKGROUND: Functional mitral regurgitation (AIR) plays a pivotal role in the pathophysiology of congestive heart failure, a major cause of cardiac morbidity and mortality. We have developed a mitral annular remodeling procedure through injection of a nonabsorbable substance into the peri-annular tissue of the posterior mitral annulus to reduce the mitral annular dimension in the septal-lateral axis. The purpose of this study is to describe a novel procedure for treatment of functional AIR and report its effects on the geometry of the mitral annulus and degree of AIR. METHODS: Seven preliminary studies were performed using an epicardial approach in a healthy dog model to establish the feasibility of this injection procedure. Unexpectedly, 2 of 7 healthy dogs had a functional AIR of grade 1 to 2+. In these 2 cases, the hemodynamic, angiographic, and echocardiographic assessments were conducted. RESULTS: A nonabsorbable substance injection was successfully performed on a beating heart without instability of hemodynamics or any evidence of myocardial ischemia in all 7 dogs. In the 2 dogs with a functional AIR, it was confirmed that the septal-lateral dimension decreased from 3.2 +/- 0.2 to 2.6 +/- 0.5 cm and the observed MR was reduced (AIR area from 1.2 +/-0.1 to 0 cm2) without any adverse effects on hemodynamics or coronary circulation (circumflex artery flow, 36.5 +/- 0.4 to 40.5 +/- 0.1 mL/min). CONCLUSION: Off-pump mitral annular remodeling through substance injection may be one procedural option for treatment of functional AIR.

Phasic coronary blood flow pattern during a continuous flow left ventricular assist support.

OBJECTIVE: Continuous flow left ventricular assist devices (LVADs) have been introduced and tested as a bridge to heart transplantation, bridge to recovery, and destination therapy, and several studies have been conducted to assess the physiologic effects of continuous flow LVADs. However, the effect of reduced pulsatility on the phasic coronary blood flow pattern is unknown. The aim of this study was to investigate the phasic coronary blood flow patterns during continuous flow LVAD support. METHODS: Phasic coronary blood flow patterns and hemodynamic data were analyzed using three flow probes placed around the left anterior descending coronary artery (LAD), left circumflex coronary artery (LCX), and the right coronary artery (RCA) in 16 pigs before and after initiating the LVAD support with or without creating LAD stenosis. RESULTS: The total coronary blood flow (TCBF, 112.8+/-31.4 mL/min) gradually decreased when the continuous flow LVAD support increased to 2.0 L/min (110.7+/-29.0 mL/min, P = 0.571), 2.5 L/min (103.7+/-26.1 mL/min, P = 0.079), and 3.0 L/min (101.5+/-27.2 mL/min, P = 0.027) because of decreases in LAD flow and LCX flow. LVAD support caused decrease in systolic and peak systolic LAD flow, LCX flow, and RCA flow, whereas diastolic RCA flow increased. In the presence of LAD stenosis, the TCBF (97.7+/-36.1 mL/min) decreased when the continuous flow LVAD support increased to 2.0 L/min (83.9+/-22.1 mL/min, P = 0.029), 2.5 L/min (83.2+/-25.2 mL/min, P = 0.012), and 3.0 L/min (87.6+/-23.4 mL/min, P = 0.005) because of decreases in LCX flow. CONCLUSION: Use of a continuous flow LVAD decreased TCBF, LAD flow, and LCX flow secondary to reduced systolic LAD flow and LCX flow, and decreased TCBF and LCX flow in the presence of LAD stenosis. These findings are potentially relevant to understanding the physiology of myocardial blood perfusion during continuous flow LVAD support especially in patients with coronary artery disease.

The pedipump: development status of a new pediatric ventricular assist device.

The PediPump is a new rotary dynamic ventricular assist device designed specifically for pediatric applications. Although it is capable of providing support for adults, the small size of the PediPump makes it suitable for newborn circulatory support while retaining excellent hemodynamics. Current and future development plans include: (1) determination of the basic engineering requirements for hardware and control logic, including design analysis for system sizing, evaluation of control concepts and bench testing of prototypes; (2) performance of preclinical anatomical fitting studies using computed tomography-based three-dimensional modeling; and, (3) evaluation with animal studies to provide characterization and reliability testing of the device.

Optimal mitral annular and subvalvular shape change created by the Coapsys device to treat functional mitral regurgitation.

We have reported that the Myocor Coapsys (Myocor, Inc, Maple Grove, MN) device treated functional mitral regurgitation (MR) by reducing mitral annular dimension and repositioning papillary muscles. This study was conducted to evaluate the optimal Coapsys device sizing level. The Coapsys device was implanted in seven dogs after induction of MR by rapid ventricular pacing. The device consists of anterior and posterior pads connected by a subvalvular cord. The device was tightened in 5% increments of the left ventricular epicardial to epicardial dimension up to 40%. Hemodynamic and echocardiographic measurements were repeated at each tightening level. The Coapsys significantly reduced or eliminated functional MR, and the reduction was maximized at the 30% tightening level or lower in all cases. Although the left ventricular end diastolic volume decreased significantly, forward stroke volume was maintained until the 35% tightening level. The forward ejection fraction significantly increased from 33 +/- 24% at baseline to 62 +/- 42% at 40% tightening level. Mean aortic pressure decreased slightly but significantly. The Coapsys device can be applied over a broad range of tightening levels with significant reduction in MR without negative physiologic impact. This feature makes the device usable [corrected] in a variety of clinical settings.

Development of a small implantable right ventricular assist device.

The purpose of this program is to design, develop, and clinically evaluate a new, implantable right ventricular assist device (RVAD) that can be used as a component of an implantable biventricular assist device for patients with severe biventricular heart failure. The initial phase of this program resulted in a prototype RVAD, named DexAide, a modified version of the CorAide left ventricular assist device. In vitro testing was performed in a stand-alone circuit and in a true RVAD mode to evaluate pump performance. Pump flow and power were measured under various afterload and pump speed conditions. The pump performance requirements of 2 to 6 l/min and a pressure rise of 20 to 60 mm Hg were successfully met with pump speeds between 1,800 and 3,200 rpm. The nominal design point of 4 l/min and 40 mm Hg pressure rise was achieved at 2,450 +/- 70 rpm with a power consumption of 3.0 +/- 0.2 W. The initial in vitro testing met the design criteria for the new DexAide RVAD. Initial in vivo testing is under way, which will be followed by preclinical readiness testing and a pilot clinical trial in this 5-year program.

Initial in vivo evaluation of the DexAide right ventricular assist device.

Despite the increasing use of left ventricular assist devices for patients with end-stage congestive heart failure, no implantable, centrifugal right ventricular assist devices (RVADs) are available for those patients with significant right ventricular failure. The DexAide RVAD was developed to provide an implantable RVAD option to surgeons. The aim of this study was to evaluate pump performance in an acute in vivo model. The DexAide RVAD, developed as a modified CorAide left ventricular assist device, was implanted between the right ventricle and the pulmonary artery in four healthy calves. Pump speed was varied from 1800 rpm to 3600 rpm. RVAD performance was analyzed acutely at baseline and under conditions of low circulating volume, high contractility, high pulmonary arterial pressure, vasodilation, and low contractility. Pump flow was well maintained even under conditions of high pulmonary arterial pressure and vasodilation, with the exception of low circulating volume. Under all conditions, pulmonary arterial pressures were not affected by changing pump speed. The DexAide RVAD demonstrated acceptable hemodynamic characteristics for use as an implantable RVAD in the initial acute studies. Further studies are ongoing to examine the biocompatibility of the pump under chronic conditions.

In vitro performance of the novel coronary sinus AutoRetroPerfusion Cannula.

Myocardial salvage through coronary sinus intervention has been documented. The AutoRetroPerfusion Cannula is a novel device that is able to perfuse the coronary bed retrogradely through the coronary sinus with arterial blood generated from a peripheral artery with no need for a pump. The cannula consists of a distal end that, once secured in the coronary sinus, opens an umbrella-like membrane to create pressure in the coronary sinus, and at the same time has small channels directed backwards to the right atrium to provide pressure relief. The cannula is introduced from the axillary vein under local anesthesia and the proximal end, which consists of a graft, is anastomosed to the axillary artery to start autoperfusion once the distal end is secured in the coronary sinus and the occluding membrane is open. The AutoRetroPerfusion Cannula was tested in the in vitro mock loop under 50-120 mm Hg of proximal pressure and 50, 100, and 150 ml/min of total flow in the cannula. We were able to achieve the nominal design point of 40-80 mm Hg of distal pressure and 50-150 ml/min of distal flow by adjusting the number, diameter, and length of the small backwards channels.

The Coapsys device to treat functional mitral regurgitation: in vivo long-term canine study.

OBJECTIVE: We evaluated the capability of the Myocor Coapsys device (Myocor, Inc, Maple Grove, Minn) to reduce functional mitral regurgitation in a canine model of dilated cardiomyopathy. METHODS: Functional mitral regurgitation with heart failure was induced in 7 dogs by rapid ventricular pacing. The Coapsys device, which consists of anterior and posterior epicardial pads connected by a subvalvular chord, was then implanted. Heart failure was maintained by continued pacing for 8 weeks. Hemodynamic and echocardiographic measurements were performed at pre- and postsizing and after 8 weeks. The Coapsys subvalvular chord was cut to verify that maintenance of valve competency was due to the device. RESULTS: All implants were performed off-pump without atriotomy. Mitral regurgitation was reduced in all animals; mean mitral regurgitation grade was reduced from 2.9 +/- 0.7 to 0.7 +/- 0.8 (P =.00005) and was maintained at 0.8 +/- 0.8 after 8 weeks, without hemodynamic compromise or structural damage to the mitral valve. Mitral regurgitation returned to 3.6 +/- 0.8 (P =.102 versus presizing) after cutting the Coapsys subvalvular chord. CONCLUSION: The Coapsys device consistently and chronically reduced functional mitral regurgitation. This device is in clinical trials in the United States.

Preclinical readiness testing of the Arrow International CorAide left ventricular assist system.

BACKGROUND: Left ventricular assist system technologies are currently being developed as effective alternatives to cardiac transplantation. In this study, in vivo testing of the Arrow International CorAide left ventricular assist system was conducted to determine its preclinical readiness based on demonstrated system performance and biocompatibility. METHODS: Arrow International CorAide blood pump assemblies were implanted in 7 calves for 1-month (n = 4) and 3-month (n = 3) durations without the use of chronic anticoagulation therapy. Hemodynamic performance, physiologic pump control, end-organ function, and device-related adverse events were evaluated during the studies and at autopsy. RESULTS: Hemodynamics were stable in all cases with a mean pump flow of 4.1 +/- 0.8 L/min and a mean arterial pressure of 101 +/- 4 mm Hg. In all calves, renal and hepatic function remained normal with no incidence of hemolysis, infection, bleeding, or embolism. The CorAide physiologic control algorithm demonstrated appropriate pump speed and flow adjustments in response to physiologically induced inputs, and the system's external electronic components demonstrated no hardware or software malfunction. All 7 cases were sacrificed electively. Autopsy revealed no sign of end-organ disease on gross and histologic examinations, and no device failure, malfunction, or mechanical wear of the pump blood-bearing surfaces was found. CONCLUSIONS: The Arrow CorAide left ventricular assist system demonstrated effective pump performance and good biocompatibility with no incidence of device-related adverse events. This system has completed its preclinical readiness testing and is approved for clinical trials in Europe in 2003.

Off-pump mitral valve repair using the Coapsys device: a pilot study in a pacing-induced mitral regurgitation model.

PURPOSE: The purpose of this study was to evaluate the ability of the Myocor Coapsys device to restore leaflet apposition and valve competency off-pump in a canine model of functional mitral regurgitation (MR). DESCRIPTION: The Coapsys device was surgically implanted in 10 dogs after MR induction by rapid ventricular pacing. The Coapsys consists of anterior and posterior epicardial pads connected by a subvalvular chord. The annular head of the posterior pad was positioned at the annular level to draw the posterior leaflet and annulus toward the anterior leaflet. Final device size was selected when MR was minimized or eliminated as assessed by color flow Doppler echocardiography. EVALUATION: All implants were placed off-pump without atriotomy, and mean MR grade was reduced from 2.9 +/- 0.7 to 0.6 +/- 0.7 (p < 0.001) acutely. No hemodynamic compromise was noted. CONCLUSIONS: The Coapsys device consistently and significantly reduced or eliminated functional MR acutely. Further study will be required to assess the chronic stability of the repair in this animal model.

Changes in mitral annular and left ventricular dimensions and left ventricular pressure-volume relations after off-pump treatment of mitral regurgitation with the Coapsys device.

OBJECTIVE: The objective of this study was to evaluate the changes in mitral annular and left ventricular dimensions and left ventricular pressure-volume relations produced by the Myocor Coapsys device that has been developed to treat functional mitral regurgitation (MR) off-pump. METHODS: The Coapsys device, which consists of anterior and posterior epicardial pads connected by a sub-valvular chord, was implanted in seven dogs with functional MR resulting from pacing induced cardiomyopathy. The Coapsys device was then sized by drawing the posterior leaflet and annulus toward the anterior leaflet. During sizing, MR grade was assessed using color flow Doppler echocardiography. Final device size was selected when MR was eliminated or minimized. Following implantation, heart failure was maintained by continued pacing for a period of 8 weeks. Mitral annular and left ventricular dimensions and left ventricular pressure-volume relations were evaluated by two-dimensional echocardiography and a conductance catheter, respectively, at pre-sizing, post-sizing, and after 8 weeks. RESULTS: All implants were performed on beating hearts without cardiopulmonary bypass. Mean MR grade was reduced from 2.9+/-0.7 at pre-sizing to 0.7+/-0.8 at post-sizing (P<0.001), and was maintained at 0.8+/-0.8 after 8 weeks (P<0.01). The septal-lateral dimensions were significantly reduced at both mitral annular level [2.4+/-0.2 cm at pre-sizing, 1.5+/-0.3 cm at post-sizing (P<0.001) and 1.8+/-0.3 cm after 8 weeks (P<0.05)] and mid-papillary level [4.1+/-0.4 cm at pre-sizing, 2.4+/-0.2 cm at post-sizing (P<0.001) and 3.3+/-0.4 cm after 8 weeks (P<0.001)]. The end-systolic pressure-volume relation shifted leftward at post-sizing with a significantly steeper slope (P=0.03). There was a significant (P=0.03) leftward shift of the end-diastolic pressure-volume relation at post-sizing. After 8 weeks, these changes in pressure-volume relations tended to return to pre-sizing relations. CONCLUSIONS: The Coapsys device significantly reduced MR by treating both the mitral annular dilatation and the papillary muscle displacement. Despite these significant dimensional changes, the Coapsys device did not negatively affect the left ventricular pressure-volume relations.

In vivo performance and biocompatibility of the MagScrew ventricular assist device.

Currently available ventricular assist devices (VADs) have limitations in long-term durability and blood compatibility. We evaluated a prototype of a pulsatile MagScrew VAD for in vivo hemodynamic performance and biocompatibility. The device is composed of an actuator, blood pump housing, diaphragm, pusher plate, and bioprosthetic valves. Its protein-coated ("biolized") blood-contacting surface inhibits clot formation. Forces between moving parts of the actuator are transmitted magnetically, eliminating a primary source of friction and wear. The pump fills passively and is highly preload sensitive. The device was implanted into three calves for 90, 10, and 57 days, respectively. No anticoagulants were given postoperatively. The device functioned without technical problems during the entire course of each experiment, with mean device flow ranging between 5.4 and 9.0 L/min. Autopsy of the first two calves revealed no sign of embolization and clean blood-contacting surfaces of the devices. The third experiment was complicated by a prosthetic valve endocarditis with infectious embolization, and a few small depositions were found in the pump. In conclusion, the MagScrew VAD has demonstrated a high level of performance and biocompatibility in three calves studied for 10-90 days. Vigorous development is in progress to bring this device to preclinical readiness and thus provide surgeons with the VAD of choice for permanent implantation.

Mitral valve repair without cardiopulmonary bypass or atriotomy using the coapsys device: device design and implantation procedure in canine functional mitral regurgitation model.

BACKGROUND: Myocor developed a unique system, the Coapsys annuloplasty system, to treat functional mitral regurgitation (MR) without cardiopulmonary bypass (CPB). This study was conducted to test the feasibility of the Coapsys implantation procedure in a canine functional MR model. METHODS: Functional MR with heart failure was induced in 9 dogs by rapid ventricular pacing (230 beats/min for 30 +/- 4 days). The Coapsys device, which consists of anterior and posterior epicardial pads connected by a subvalvular chord, was then surgically implanted. Under epicardial echocardiographic guidance, we placed the Coapsys device across the left ventricular chamber using the delivery instrument and needle assembly. We sized the Coapsys device by drawing the posterior leaflet and annulus toward the anterior leaflet with the sizing instrument. Final device size was selected when MR was minimized or eliminated as assessed by 2-dimensional color Doppler echocardiography. RESULTS: In all cases, we successfully implanted the Coapsys device without CPB or atriotomy. MR was reduced an average of 2 grades. No adverse events, such as hemodynamic compromise or structural valve damage, were noted. CONCLUSION: Coapsys device implantation was feasible and safe on a beating canine heart. All accessory tools used for device implantation were found useful.

Acute reduction of functional mitral regurgitation in canine model using an epicardial device.

PURPOSE: This study evaluated the short-term feasibility of a novel epicardial device that treats functional mitral regurgitation by simultaneously changing the mitral and the left ventricular geometry. DESCRIPTION: We implanted a prototype device that consists of 2 tissue anchors, a deflector, and a flexible tightening chord in 7 mongrel dogs with heart failure and functional mitral regurgitation induced by rapid ventricular pacing. Hemodynamic and echocardiographic data were obtained before and after device implantation. EVALUATION: The device acutely reduced the mitral regurgitation grade from 3.2 +/- 0.3 to 0.9 +/- 0.5 (p < 0.001). Left ventricular end-diastolic volume (79.6 +/- 23.6 to 61.2 +/- 16.9 mL; p = 0.004) and end-systolic volume (63.1 +/- 17.3 to 49.2 +/- 12.3 mL; p = 0.006) decreased substantially. End-systolic elastance significantly increased from 1.9 +/- 1.0 to 2.6 +/- 1.4 mm Hg/mL (p = 0.02). Device implantation did not alter coronary perfusion. CONCLUSIONS: The epicardial device acutely reduced functional mitral regurgitation and improved left ventricular geometry. Further studies are required to demonstrate the long-term safety and efficacy of this concept.