Biomedical subjects

Michael W Kopcak

Publications and source records attributed to Michael W Kopcak.

At least 19 recordsLinked to original sources

PubMed2007

Impact of left atrial appendage exclusion on left atrial function.

OBJECTIVES: We sought to investigate the short-term and midterm effects of left atrial appendage exclusion on left atrial function. Left atrial appendage exclusion is considered a possible therapeutic option for stroke prevention in patients with atrial fibrillation. Favorable outcomes have encouraged widespread use of left atrial appendage exclusion for cardiac surgical patients-even for patients in sinus rhythm who have stroke risk factors; however, the chronic effects on left atrial function of left atrial appendage exclusion are unclear. METHODS: Nineteen mongrel dogs (29.7 +/- 5.2 kg) in sinus rhythm were studied. The Doppler signals from the pulmonary venous flow, transmitral flow, and tissue Doppler imaging of mitral annular motion were obtained before and after left atrial appendage exclusion. Dogs were evaluated in the same manner at 7 days (n = 2), 30 days (n = 7), or 90 days (n = 10) after left atrial appendage exclusion. RESULTS: Except for a significant increase in early diastolic transmitral flow velocity after left atrial appendage exclusion (P = .01), no significant differences were found in any parameters related to the transmitral flow and tissue Doppler imaging measurements throughout follow-up. The systolic components of pulmonary venous flow at follow-up revealed a significant reduction relative to baseline (peak systolic velocity P < .0001, systolic velocity-time integral P < .0001), despite the lack of significant changes in left atrial pressure, left ventricular volume, and stroke volume. CONCLUSION: Left atrial appendage exclusion may affect left atrial reservoir function in the short-term and midterm periods. Further long-term studies with more clinically relevant models are needed.

Animals↗

PubMed2006

Ventral cardiac denervation increased right coronary arterial blood flow.

BACKGROUND: Cardiac denervation accompanied with coronary artery bypass surgery has been widely performed for the treatment of vasospastic angina associated with atherosclerotic coronary artery disease. However, the effect of cardiac denervation on phasic coronary blood flow patterns of the left anterior descending coronary artery (LAD), left circumflex coronary artery (LCX) and right coronary artery (RCA) remains unknown. This study aimed to investigate the effect of cardiac denervation on phasic coronary blood flow patterns of the LAD, LCX and RCA. METHODS: Phasic coronary blood flow patterns were analyzed using three flow probes placed around the LAD, LCX and RCA with and without LAD stenosis. Ventral cardiac denervation (VCD) was performed in 8 pigs, and 16 pigs were used as control subjects. Autonomic activities before and after the VCD were quantified by wavelet analysis of heart rate variability. RESULTS: The mean LAD flow (34.4+/-9.4 to 32.6+/-7.1 ml/min, p=0.638) and mean LCX flow (26.3+/-10.2 to 27.2+/-6.0 ml/min, p=0.825) showed no significant change after VCD, while the mean RCA flow (31.3+/-9.0 to 38.2+/-11.2 ml/min, p=0.003) significantly increased. The hemodynamic variables in the VCD group were well maintained after creation of LAD stenosis, while they deteriorated in the control group. The low-frequency components, high-frequency components and their ratio did not change after VCD. CONCLUSIONS: VCD prevented the deterioration of cardiac function after creation of an LAD stenosis and resulted in an increase of the mean RCA flow. VCD did not affect autonomic nervous system activity.

Angina Pectoris↗

PubMed2006

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.

Animals↗

PubMed2006

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.

Animals↗

PubMed2006

Evaluation of a novel device for left atrial appendage exclusion: the second-generation atrial exclusion device.

BACKGROUND: The left atrial appendage is a frequent source of thromboemboli in patients with atrial fibrillation. Exclusion of the left atrial appendage may reduce the risk of stroke in patients with atrial fibrillation. The atrial exclusion device, previously developed to perform left atrial appendage exclusion on a beating heart, was modified to accommodate different anatomic patterns of the human left atrial appendage and to ensure uniform pressure and occlusion. The purpose of this study was to evaluate this second-generation atrial exclusion device during a midterm period in a canine model. METHODS: Ten mongrel dogs (mean weight 28.9 +/- 4.6 kg) were used in this study. The atrial exclusion device, constructed from two parallel and rigid titanium tubes and two nitinol springs with a knit-braided polyester fabric, was implanted at the base of the left atrial appendage through a left thoracotomy on a beating heart using a specially designed delivery tool. Dogs were evaluated at 30 days (n = 4) and 90 days (n = 6) by epicardial echocardiography, left atrial and coronary angiography, gross pathology, and histologic inspection. RESULTS: Device implantation was performed without complications in all dogs. Complete left atrial appendage exclusion without device migration or hemodynamic instability was confirmed, and there was no damage to the left circumflex artery or pulmonary artery. Macroscopic and microscopic assessments revealed favorable biocompatibility during midterm follow-up. CONCLUSION: The atrial exclusion device enabled rapid, reliable, and safe exclusion of the left atrial appendage. Clinical application may provide a new therapeutic option for reducing the risk of stroke in patients with atrial fibrillation.

Animals↗

PubMed2005

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.

Animals↗

PubMed2005

MagScrew total artificial heart in vivo performance above 200 beats per minute.

PURPOSE: Downsizing pulsatile devices requires an increase of beat rate if flow capacity is to be maintained. We applied this concept to the preclinical MagScrew total artificial heart (TAH). DESCRIPTION: The device fills passively with a stroke volume of 45 ml and beat rates up to 250 beats per minute (bpm). EVALUATION: Stable hemodynamics were observed during a 30-day bovine implant with a flow of 8.7 +/- 1.2 L/min at beat rates of 204 +/- 18 bpm. Device filling was exceptional up to 250 bpm generating flow of greater than 12 L/min. Beat rate adapted to preload in a way similar to a Frank-Starling response. Left and right atrial pressures were balanced. The aortic pulse pressure was 49-70 mm Hg, which translates to a pulsatility index of 0.49-0.77. Organ functions were preserved and blood damage did not occur. CONCLUSIONS: Increasing the beat rate while downsizing the MagScrew TAH was successful with strong flow generation by passive filling. Pulsatility was maintained at high beat rates. This innovative approach may be used to develop small pulsatile pumps.

Animals↗

PubMed2005

A novel device for left atrial appendage exclusion.

OBJECTIVE: The left atrial appendage is a frequent source of thromboemboli in patients with atrial fibrillation. Exclusion or excision of the left atrial appendage may reduce the risk of stroke in patients with atrial fibrillation. We evaluated the ability of a novel device to exclude the left atrial appendage during early and intermediate follow-up periods in a canine model. METHODS: Eight mongrel dogs (mean weight 29.1 +/- 4.0 kg) were used in this study. The occlusion device, constructed from 2 stainless steel strips covered with a knit braided polyester fabric, was implanted at the base of the left atrial appendage through a left thoracotomy on a beating heart. Dogs were evaluated at 7 days (n = 2), 30 days (n = 2), and 90 days (n = 4) by epicardial echocardiography, left atrial angiography, histologic inspection, and gross pathology. RESULTS: Device implantation was performed without complications in all animals. Complete exclusion of the left atrial appendage from the circulation was confirmed acutely and chronically by echocardiographic and angiographic evaluations. There was no device migration or damage to adjacent structures. CONCLUSION: This novel device enables rapid, reliable, and safe exclusion of the left atrial appendage. The device provides a new therapeutic option for reducing the risk of stroke in patients with atrial fibrillation.

Animals↗

PubMed2005

The PediPump: a new ventricular assist device for children.

Options for mechanical circulatory support for the treatment of end-stage heart failure in children are limited. Ventricular assist devices (VADs), which have revolutionized cardiac care in adults, remain largely unavailable for pediatric applications. The PediPump is a new rotary dynamic VAD designed to provide support for the entire range of patient sizes encountered in pediatrics. Despite being much smaller than currently available VADs, which makes it suitable for even newborn circulatory support, the PediPump demonstrates excellent hemodynamic performance.

Child↗

PubMed2004

Preload-adjusted right ventricular maximal power: concept and validation.

Right ventricular (RV) maximal power (PWR(mx)) is dependent on preload. The objective of this study was to test our hypothesis that the PWR(mx) versus end-diastolic volume (EDV) relationship, analogous to the load-independent stroke work (SW) versus EDV relationship (preload-recruitable SW, PRSW), is linear, with the PWR x-axis intercept (V(0PWR)) corresponding to the PRSW intercept (V(0SW)). If our hypothesis is correct, the preload sensitivity of PWR(mx) could be eliminated by adjusting for EDV and V(0PWR). Ten dogs were instrumented with a pulmonary flow probe, micromanometers, and RV conductance catheter. Data were obtained during bicaval occlusions under various conditions and fitted to PWR(mx) = a.(EDV - V(0PWR))(beta), where a is the slope of the relationship. The PWR(mx) versus EDV relationship did not deviate from linearity (beta = 1.09, P = not significant vs. 1), and V(0PWR) correlated with V(0SW) (r = 0.93, P <0.0001). V(0PRW) was related to steady-state EDV and left ventricular end-diastolic pressure, allowing for estimation of V(0PWR) (V(0Est)) and single-beat PWR(mx) preload adjustment. Dividing PWR(mx) by the difference of EDV and V(0PWR) (PAMP(V0PWR)) eliminated preload dependency down to 50% of the baseline EDV. PWR(mx) adjustment using V(0Est) (PAMP(V0Est)) showed similar preload independency. Enhancing contractility increased PAMP(V0PWR) and PAMP(V0Est) from 176 +/- 52 to 394 +/- 205 W/ml x 10(4) and 145 +/- 51 to 404 +/- 261 W/ml x 10(4), respectively, accompanied by an increase of PRSW from 13.0 +/- 4.5 to 29.7 +/- 16.4 mmHg (all P <0.01). PAMP(V0PWR) and PAMP(V0Est) correlated with PRSW (r = 0.85; r = 0.77; both P <0.001). Numerical modeling confirmed the accuracy of our experimental data. Thus preload adjustment of PWR(mx) should consider a linear PWR(mx) versus EDV relationship with distinct V(0PWR). PAMP(V0PWR) is a preload-independent estimate of RV contractility that may eventually be determined noninvasively.

Animals↗

PubMed2004

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.

Animals↗

PubMed2004

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.

Animals↗

PubMed2004

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.

Animals↗

PubMed2004

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.

Animals↗

PubMed2004

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.

Animals↗

PubMed2003

Determinants of the development of mitral regurgitation in pacing-induced heart failure.

The pacing-induced heart failure model provides an opportunity to assess the structural and functional determinants of mitral regurgitation (MR) in dilated cardiomyopathy. This study aimed to evaluate MR to better understand the multitude of factors contributing to its development. Heart failure was induced by rapid ventricular pacing (230 beats/min) in 40 mongrel dogs. Left ventricular (LV) size and MR were evaluated echocardiographically. LV contractility was analyzed using a conductance catheter. MR increased to mild in 12 animals (regurgitant orifice area, 0.06+/-0.05 cm(2)), moderate in 15 (0.14+/-0.07 cm(2)), and severe in 13 (0.34+/-0.16 cm(2)). The grade of MR had an inverse relationships with E(max) (the slope of the end-systolic pressure-volume relationship, p<0.01) and dE/dt (the slope of the maximum rate of change of pressure-end-diastolic volume [V(ED)] relationship, p<0.01) and positive relationships with V(ED) and end-diastolic cross-sectional areas and lengths (p<0.05) by univariate analysis. The dE/dt had an independently significant (p<0.01) relationship by multivariable logistic regression. Many factors influence the development of MR and because of its similarity to the clinical situation, this model can be used to investigate MR and heart failure, as well as new surgical therapies.

Animals↗

PubMed2002

Chronic evaluation of the Cleveland Clinic CorAide left ventricular assist system in calves.

The Cleveland Clinic CorAide left ventricular assist system is based on a third-generation, implantable, centrifugal pump in which a rotating assembly is suspended fully. To evaluate chronic in vivo system performance and biocompatibility, the CorAide blood pump was implanted in 18 calves for either 1 month or 3 months. Hemodynamics were stable in all calves with a mean pump flow of 5.9 +/- 1.2 L/min and a mean systemic arterial pressure of 98 +/- 5 mm Hg. There were no incidences of bleeding, organ dysfunction, or mechanical failure in any of the 18 calves. Hemolysis occurred in only 1 calf due to outflow graft stenosis. Thrombus inside the pump, seen in 4 of the first 6 cases, was totally eliminated by a final redesign in the remaining cases, including the last 6 implants conducted without anticoagulation therapy. The CorAide blood pump demonstrated good biocompatibility and reliable, effective system performance.

Animals↗

PubMedDate not supplied

Device-based left ventricular geometry change for heart failure treatment: developmental work and current status.

BACKGROUND: Device-based left ventricular (LV) geometry change is a new concept in the treatment of heart failure that reduces LV wall stress and improves cardiac function by reducing effective LV radius. Ventricular geometry change is achieved by placement of three Myosplint devices to bisect the LV and to create two smaller LV chambers. METHODS AND RESULTS: Since the first animal experiment in June 1997, the Myosplint has been tested extensively in a series of animal studies using a pacing-induced, canine dilated cardiomyopathy model. Device-based LV geometry change decreased LV wall stress, improved systolic function, and maintained diastolic function, resulting in an improvement in myocardial energetics. An acute human feasibility study during heart transplant surgery was started in July 1999. While awaiting the arrival of the donor heart, the Myosplint was implanted in the recipient LV in 5 patients. The device was easily applied on a beating heart without complications related to the device or the procedure in any of the patients. LV wall stress was significantly decreased after tightening of the device. Clinical safety studies with chronic Myosplint implantation were begun in Germany in June 2000 and in the United States in February 2001. There have been a total of 21 patients receiving the implant without evidence of bleeding, muscle tearing, severe arrhythmia, or thrombus formation associated with the implant. CONCLUSIONS: Device-based geometry change has been demonstrated to be practical, effective, and safe.

Animals↗