[Surgical Left Atrial Ablation Through the Left Atrial Appendage During Aortic Valve Replacement].

This is a 2-case report of concomitant left atrial( LA) surgical ablation through the left atrial appendage( LAA) for atrial fibrillation( AF) during aortic valve replacement( AVR). Case 1, a 74-year-old man, and Case 2, an 85-years-old woman, were presented for AVR and AF. Under the cardio-pulmonary bypass, right and left pulmonary vein isolations( PVIs) were performed with radiofrequency( RF) ablation devices. Through the opened LAA, an RF lesion was placed to connect the bilateral PVIs and the LAA, and another RF line was placed toward the mitral annulus. A right atrial( RA) isthmus ablation was also performed through a RA incision. Postoperatively, sinus rhythm and both RA and LA contraction were obtained, and have been maintained for 7.5 and 5 years without classⅠ/Ⅲ antiarrhythmic drugs in Case 1 and 2, respectively. This procedure is considered to be effective and safe, although further study is needed.

[Tricuspid Valve Ring Annuloplasty with Posterior Annular Plication for Functional Tricuspid Regurgitation].

This report presents a modified procedure of tricuspid valve ring annuloplasty (R-TAP) with posterior annular plication for functional tricuspid regurgitation (TR). Sutures on the native annulus were placed by a standard fashion in R-TAP, and those on the posterior annulus and its bilateral commissures were passed through in a narrow range between the 3 and 4 o'clock positions of the 26-mm ring. The other sutures were done with an usual manner and the ring was fixed to the annulus, resulting in the posterior annular plication( bicuspidization). Follow-up was performed for more than 5 years( mean: 7.9 years, range:5.5~11.5 years) by echocardiography in 13 cases. Postoperative TR reduced significantly to less than moderate, which was maintained during the entire follow-up period, even in the case with atrial fibrillation. There was no sign of tricuspid stenosis. R-TAP with posterior annular plication was feasible, reproducible, and effective, although further investigation is needed.

[Preservation of the Spinal Perfusion Artery during Descending Thoracic and Thoracoabdominal Aortic Surgery].

This is a 3-case report of successful descending thoracic and thoracoabdominal aortic surgery by preserving the spinal perfusion artery (SPA) identified preoperatively. In Case 1, an 85-year-old woman, computed tomography (CT) showed Crawford type Ⅴ thoracoabdominal aortic aneurysm (TAAA:60 mm) and a SPA originated from L2. In Case 2, a 76-year-old man, CT revealed type Ⅳ TAAA( 58 mm) and a SPA originated from Th11. In Case 3, a 74-year-old man, CT detected an infectious pseudoaneurysm(44 mm) in the descending thoracic aorta with 2 SPAs originating from Th10 and L2. The ranges of graft replacement were Th7-Th12, Th12-L4, and Th8-Th10, respectively, while preserving all SPAs. All patients recovered well without postoperative neurological deficits. Although the protective effect of the SPA preservation against the spinal cord ischemia is still controversial, preoperative identification of the SPA was useful for planning a surgical strategy for descending thoracic and thoracoabdominal aortic repair surgery.

[Mitral Valve Replacement with the On-X Valve].

This is a 3-case report of mitral valve replacement (MVR) with an On-X mechanical valve followed up to 10 years. Case 1(64-year-old man) and case 2 (66-year-old woman) experienced traffic accident and traumatic event, respectively, in their chronic phase after MVR. Case 1 had multiple bone fractures of the bilateral lower limbs, which was followed by systemic infection and pyogenic spondylitis. He needed long-term antibiotics therapy for more than 4 years. Case 2 fell down at home and severely hit her head, which resulted in a traumatic subarachnoid hemorrhage. She was in a deep coma, and needed discontinuation of anticoagulation therapy for 4 weeks. Case1, 2, and 3(54-year-old man) are doing well in New York Heart Association functional class I without any valve-related thromboembolic or hemorrhagic events at 10, 9 and 8 years after MVR, respectively. On-X valve performance has also been found well maintained in all cases by echocardiography, even after traumatic accident or discontinuation of anticoagulation in Case 1 and 2. In this report, the On-X mechanical valve demonstrated good midterm result of its valve performance in the mitral position and its potential advantages in antithrombogenicity.

[Retrosternal Giant Aortic Aneurysm;Report of Two Cases].

This is a 2-case report of successful aortic repair surgery for the retrosternal giant aortic aneurysm. Our surgical strategy is "deep hypothermia and left ventricular( LV) unloading under cardiopulmonary bypass before approaching to the aortic aneurysm" in case of possible catastrophic bleeding. Case 1, a 64-year-old woman, had a retrosternal pseudoaneurysm (80 mm) at the distal anastomosis of a Dacron graft used to replace the ascending aorta 7 years before. An LV vent tube was cannulated via the right upper pulmonary vein through an inferior T-shaped ministernotomy. Case 2, an 86-year-old woman, had a retrosternal chronic aortic dissecting aneurysm (66 mm). An LV vent cannula was inserted via the LV apex through a left minithoracotomy. Arch replacement and ascending aorta replacement were performed in Case 1 and 2, respectively, without cardiac, neurological, or any other complications. This strategy is safe and useful in a case with complex aortic disease.

[Intraoperative Endoscopic Evaluation of the Aortic Valve in Aortic Valve Repair].

This report discusses intraoperative endoscopic evaluation of the aortic valve performed in 2 cases of aortic valve repair. The "direct" or real image by the endoscopy helped to confirm the preoperatively-known lesion and even to detect a new legion which was not detected preoperatively. The endoscopy also enabled the evaluation of the aortic valve under the pressure-loaded condition without releasing the aortic clamp. Postoperative aortic regurgitation was grade I or less in both cases, although it progressed to grade II at 1 year in case 2. Echocardiographic parameters demonstrated no change in the size of the aortic root configuration for 8 and 5 years in case 1 and case 2, respectively. Intraoperative aortic endoscopy was useful to define the pathogenesis of aortic regurgitation and to evaluate the cusp repair procedures, which may contribute to a good mid-term result of aortic valve repair.

[Aortic arch replacement placing priority on cardiac and cerebral reperfusion].

In this report, aortic arch replacement was performed successfully in 2 cases with our modified method placing priority on the cardiac and cerebral reperfusion, resulting in no postoperative cardiac or neurological complication. One was a 63-year-old man with old cerebral infarction and ischemic heart disease, and the other was a 72-year-old man with severe stenosis of the left common carotid arteries. Our method is similar to so-called "arch first technique". First, the ascending aorta is clamped and proximal anastomosis is accomplished during core cooling, followed by reconstruction of the brachiocephalic arteries under deep hypothermic circulatory arrest. Then perfusion of the heart and brain is restarted, while distal anastomosis is performed. It was proved that the method had several possible advantages such as minimized duration of brain ischemia and deep hypothermia, and elimination of direct cannulation to the branches of the aortic arch and a separate perfusion circuit for the brain.

[Three-dimensional demonstration of the spinal cord artery with 64-row computed tomography].

This is a report of 2 cases, in which preoperative 3-dimentional demonstration of the spinal cord artery with 64-row computed tomography was feasible, less invasive, less time-consuming, and helpful in making an interventional strategy for complex aortic disease, resulting in no postoperative paraplegia One was a 63-year-old man, who underwent total arch replacement and a long elephant trunk method for arch and descending aortic aneurysms. The length of the long elephant trunk was so determined that it ended between the descending aortic aneurysm and the origin of the spinal cord artery. The second case was a 59-year-old man, who underwent descending thoracic aorta replacement for type B aortic dissection. During the distal anastomosis, the dissection septa were trimmed in order to perfuse the blood into the true and 2 false channels, one of which was connected to the spinal cord artery. In this report, we are not suggesting that preservation of the demonstrated spinal cord artery is enough for spinal cord protection, because it is still controversial. Further study is needed to confirm the reliability and reproducibility of our methods.

Predictors of severe right ventricular failure after implantable left ventricular assist device insertion: analysis of 245 patients.

BACKGROUND: Insertion of an implantable left ventricular assist device (LVAD) complicated by early right ventricular (RV) failure has a poor prognosis and is largely unpredictable. Prediction of RV failure after LVAD placement would lead to more precise patient selection and optimal device selection. METHODS AND RESULTS: We reviewed data from 245 patients (mean age, 54+/-11 years; 85% male) with 189 HeartMate (77%) and 56 Novacor (23%) LVADs. Ischemic cardiomyopathy predominated (65%), and 29% had dilated cardiomyopathy. Overall, RV assist device (RVAD) support was required after LVAD insertion for 23 patients (9%). We compared clinical and hemodynamic parameters before LVAD insertion between RVAD (n=23) and No-RVAD patients (n=222) to determine preoperative risk factors for severe RV failure. By univariate analysis, female gender, small body surface area, nonischemic etiology, preoperative mechanical ventilation, circulatory support before LVAD insertion, low mean and diastolic pulmonary artery pressures (PAPs), low RV stroke work (RVSW), and low RVSW index (RVSWI) were significantly associated with RVAD use. Elevated PAP and pulmonary vascular resistance were not risk factors. Risk factors by multivariable logistic regression were preoperative circulatory support (odds ratio [OR], 5.3), female gender (OR, 4.5), and nonischemic etiology (OR, 3.3). CONCLUSIONS: The need for circulatory support, female gender, and nonischemic etiology were the most significant predictors for RVAD use after LVAD insertion. Regarding hemodynamics, low PAP and low RVSWI, reflecting low RV contractility, were important parameters. This information may lead to better patient selection for isolated LVAD implantation.

Reduction of mitral regurgitation using the Coapsys device: a novel ex vivo method using excised recipients' hearts.

The purpose of this study was to evaluate the ex vivo effects of the Coapsys device upon functional mitral regurgitation (MR) in human hearts. We used seven excised hearts from patients who underwent cardiac transplantation. All patients had functional MR of grade 2 or greater associated with dilated (n = 3) or ischemic (n = 4) cardiomyopathy. After the aortic valve was removed, the left ventricle was pressurized from the aorta with saline at a constant pressure. The degree of MR was then subjectively graded from the opened left atrium (from 0 to 4). The last three studies included volumetric measurements of MR. By tightening the device, the mean MR grade was reduced from 3.3 +/- 0.8 to 1.1 +/- 0.4 (p = 0.0002). In the quantitative analysis, mean regurgitation volume was reduced from 1,108 +/- 1,134 ml/min to 236 +/- 89 ml/min (p = not significant). The mitral annular septal-lateral dimension decreased from 2.0 +/- 0.3 cm to 1.6 +/- 0.5 (p = 0.043). The Coapsys device reduced functional MR in the ex vivo study using excised dilated hearts.

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.

Neurohormonal response to left ventricular reconstruction surgery in ischemic cardiomyopathy.

OBJECTIVES: Activation of the neuroendocrine axis in congestive heart failure is of prognostic significance, and neurohumoral blocking therapy prolongs survival. The hypothesis that surgical reduction of left ventricular size and function decreases neuroendocrine activation is less established. We evaluated the neurohormonal response to left ventricular reconstruction surgery in ischemic cardiomyopathy. METHODS: Norepinephrine, plasma renin activity, and angiotensin II were measured in 10 patients before and 12 months after left ventricular reconstruction. In an additional 5 patients, brain natriuretric peptide was measured before and 3 months postoperatively. Three-dimensional cardiovascular imaging was used to assess ejection fraction and left ventricular end-diastolic volume index. RESULTS: Concurrent with improvements of New York Heart Association functional class (2.9 +/- 0.5 preoperatively vs 2.0 +/- 0.4 postoperatively, P <.001), ejection fraction (23.9% +/- 6.6% vs 36.2% +/- 6.2%, P <.01), and left ventricular end-diastolic volume index (140.8 +/- 33.8 mL/m(2) vs 90.6 +/- 18.3 mL/m(2), P <.01), considerable reductions were observed for median plasma profiles of norepinephrine (562.0 pg/mL vs 319.0 pg/mL, P <.05), plasma renin activity (5.75 microg/L/h vs 3.45 microg/L/h, P <.05), angiotensin II (41.0 ng/mL vs 23.0 ng/mL, P =.051), and brain natriuretric peptide (771.0 pg/mL vs 266.0 pg/mL, P <.05). The more plasma renin activity or angiotensin II decreased after left ventricular reconstruction, the higher was the increase in ejection fraction (R = -.745, P <.05 [plasma renin activity]; R = -.808, P <.05 [angiotensin II]). CONCLUSIONS: Surgical improvements of ejection fraction and left ventricular end-diastolic volume index by left ventricular reconstruction were accompanied by improvement of both the neuroendocrine activity and the functional status in patients with congestive heart failure. Whether this favorable neurohormonal response is predictive of an improved survival requires further evaluation.

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.

Echocardiographic assessment of regional ventricular function after device-based change of left ventricular shape.

We assessed the effects of implantation of Myosplint (Myocor, Maple Grove, Minn), a device that changes left ventricular (LV) cross-sectional shape from circular to bilobar, on regional LV function. A total of 10 open-chest dogs with tachycardia-induced cardiomyopathy were studied before and after Myosplint implantation. LV cross-sectional epicardial echocardiography at the papillary muscle level was performed along with acquisition of hemodynamic data. LV normalized thickening, fractional thickening, end-diastolic thickness, and end-diastolic curvatures were calculated for 10 LV segments. Myosplint implantation did not affect LV hemodynamics, but decreased average end-diastolic curvature (P <.0001) and increased its segmental heterogeneity (P <.0001). There was no change in average fractional thickening, whereas normalized thickening increased (P =.05). In contrast, segmental heterogeneity of both normalized and fractional thickening increased (P =.02 and P =.01, respectively). Structural modeling confirmed that Myosplint implantation increases regional stress heterogeneity and curvature heterogeneity. LV cross-sectional shape markedly affects regional LV performance.

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 vitro controllability of the MagScrew total artificial heart system.

The purpose of this study was to evaluate the in vitro responses to preload and afterload of our total artificial heart (TAH), the MagScrew TAH. The TAH consists of two blood pumps and a control logic, developed at the Cleveland Clinic, OH, and the MagScrew actuator and its electronic control system, developed by Foster-Miller Technologies, Inc., Albany, NY. Tests were performed on a mock circulatory loop, using water as a test fluid. Preload sensitivity of the Mag-Screw TAH demonstrated a Frank-Starling response to preload in automatic mode. A peak flow of 10 L/min was obtained, with a left atrial pressure of 13 mm Hg. The relationship between right atrial pressure and left atrial pressure was well balanced when tested with a left bronchial shunt flow of 5% and a range of pulmonary artery and aortic pressures. With respect to afterload response, the left pump showed a relatively low sensitivity, which allowed the pump to maintain perfusion over a wide range of aortic pressures. The right pump, on the other hand, was much more sensitive to pulmonary artery pressure, which provided a measure of protection against pulmonary congestion. The very effective physiologic response of the MagScrew TAH is believed to result from employment of a left master, alternating ejection control logic, high inherent sensitivity of the blood pumps to atrial pressure, a lower effective stroke volume for the right pump, and a scaling of right side motor ejection voltage to 80% of that used for the left side ejection.

Device based left ventricular shape change: validation of conductance technology in shape changed hearts.

We have reported that device based left ventricular (LV) shape change, accomplished by Myosplint, improved LV systolic function by three-dimensional echocardiography (3-D echo). However, evaluation of this device using the pressure-volume relationship is still important. This study was conducted to validate the use of conductance technology for this evaluation in shape-changed hearts. An ex vivo study using excised ovine hearts (n = 11) and an in vivo study using a canine pacing-induced heart failure model (n = 11) were performed. Three Myosplints were implanted. Before and after the shape changes, volumes measured by a conductance catheter were compared with volumes measured by the amount of saline in the ex vivo study or by 3-D echo in the in vivo study. The conductance volumes were linearly correlated with the saline volumes (r2 = 0.961+/-0.046; p < 0.0001) in the ex vivo study and with 3-D echo volumes (r2 = 0.757+/-0.220; p < 0.0001) in the in vivo study. The conductance volumes were linearly correlated with LV volumes even in the shape-changed hearts. This technology can be used to evaluate pressure-volume loops in the shape-changed hearts as long as the conductance volume is calibrated by a reliable method.

In vivo studies of the MagScrew total artificial heart in calves.

The purpose of this study was to evaluate the in vivo pump performance of our total artificial heart (TAH), the "MagScrew TAH." The TAH consists of a blood pump and control logic developed at the Cleveland Clinic and the MagScrew actuator and electronic control system developed by Foster-Miller Technologies, Inc. (Albany, NY). MagScrew TAH implantation was performed in two calves. Study durations were 50 and 5 days. The causes of termination were prosthetic valve endocarditis in one case and cable failure in the other. Mean left pump flow ranged from 8.0 to 9.7 L/min, with left atrial pressure of 3.0 to 16.0 mm Hg. Preload sensitivity of the MagScrew TAH demonstrated a Frank-Starling response to preload in automatic mode. The relationship between right and left atrial pressure was well balanced. Mean arterial pressure and mean pulmonary artery pressure were maintained within physiologic ranges over study duration. There were no signs of bleeding, hemolysis, or organ failure. The MagScrew TAH showed physiologic pump performance, and hemodynamics were well maintained without any organ failure. Further development testing will bring the MagScrew TAH to the point of preclinical readiness testing.

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.