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1.
Circulation ; 100(19 Suppl): II236-43, 1999 Nov 09.
Article in English | MEDLINE | ID: mdl-10567310

ABSTRACT

BACKGROUND: Biventricular direct cardiac compression (DCC) has the potential to support the failing heart without the complications associated with a blood/device interface encountered with the use of current ventricular assist devices. A clinically designed DCC device that provides compression pressure around the base of the heart in synchrony with native ventricular contractions was evaluated with the use of an ex vivo and in vivo canine model of heart failure. METHODS AND RESULTS: The device was tested over a series of ventricular preloads with the use of an ex vivo canine heart preparation and computerized afterload system that mimicked the conditions of heart failure. The end-systolic pressure-volume relation of the left and right ventricles was shifted upward in parallel by DCC, with the magnitude of the shift averaging 40% of the device compression pressure. The device was tested in vivo with the use of a canine model of acute ischemic heart failure in which graded reductions in ventricular function were created through serial coronary artery embolizations. Under the most severe condition of heart failure, DCC improved cardiac output (CO) by 104% (0.80+/-0.33 to 1.63+/-0.40 L/min) and mean arterial pressure by 95% (45.6+/-11 to 89.0+/-18.2 mm Hg). The CO was typically restored to approximately 60% of the normal baseline value, despite attempts to further increase CO by increasing the amount or duration of compression pressure. CONCLUSIONS: Nonuniform DCC significantly improves the left and right ventricular pressure-generating capability and, in the setting of acute heart failure, can increase CO and mean arterial pressure. Such DCC devices can potentially avoid the complications associated with currently available ventricular support devices that involve a blood/device interface.


Subject(s)
Heart-Assist Devices , Shock, Cardiogenic/physiopathology , Shock, Cardiogenic/therapy , Animals , Dogs , Echocardiography , Hemodynamics , Male , Ventricular Function, Left
2.
Ann Thorac Surg ; 68(2): 688-94, 1999 Aug.
Article in English | MEDLINE | ID: mdl-10475472

ABSTRACT

BACKGROUND: The use of left ventricular assist devices (LVADs) as bridge to transplantation is now accepted as a standard of care for a subset of end-stage heart failure patients. Our interim experience with both pneumatically and electrically powered ThermoCardiosystems LVADs is presented to outline the benefits and limitations of device support as well as discuss its potential role as bridge to recovery and as destination therapy. METHODS AND RESULTS: Detailed records were kept prospectively for all patients undergoing LVAD insertion. One hundred LVADs were inserted over 7 years into 95 patients, with an overall survival rate of 75% and a transplantation rate of 70%. Four patients underwent device explant for recovered myocardial function. Three patients received LVADs as destination therapy in the ongoing REMATCH (Randomized Evaluation of Mechanical Assist Treatment for Congestive Heart failure) trial. Overall mean patient age was 51 years, and mean duration of support was 108 days. There were 25 device-related infections including the drive line, device pocket, and blood-contacting surfaces. Cerebral vascular accidents and other embolic events occurred in 7 patients with six deaths. There were four device malfunctions and nine graft-related hemorrhages, resulting in six reoperations and three deaths. CONCLUSIONS: The use of long-term implantable LVADs will likely not be limited to bridge to transplantation. The REMATCH trial has commenced to study the role LVADs may have as an alternative to medical management. Furthermore, as the issues of myocardial recovery are examined, the "bridge to recovery" may be an important additional role for these assist devices.


Subject(s)
Heart Failure/surgery , Heart-Assist Devices , Cause of Death , Equipment Failure , Female , Follow-Up Studies , Heart Failure/etiology , Heart Failure/mortality , Heart Transplantation , Hospital Mortality , Hospitals, University , Humans , Long-Term Care , Male , Middle Aged , New York City , Survival Rate
3.
Circulation ; 99(16): 2177-84, 1999 Apr 27.
Article in English | MEDLINE | ID: mdl-10217660

ABSTRACT

BACKGROUND: Biventricular direct cardiac compression (DCC) can potentially support the failing heart without the complications associated with a blood/device interface. The effect of uniform DCC on left and right ventricular performance was evaluated in 7 isolated canine heart preparations. METHODS AND RESULTS: A computer-controlled afterload system either constrained the isolated heart to contract isovolumically or simulated hemodynamic properties of physiological ejection. Biventricular DCC was provided by a chamber surrounding the heart that allowed adjustment of the compression pressure, onset time, and duration. Through a series of ventricular preloads, the effect of DCC on the end-systolic pressure-volume relationship (ESPVR) was evaluated under isovolumic and ejecting conditions. Under both conditions, DCC shifted the ESPVR of the left and right ventricles upward by an amount approximately equal to the compression pressure. The augmentation of end-systolic pressure for each initial preload tested, however, was less under ejecting conditions, because reductions in end-systolic and end-diastolic volumes occurred with ejection. Nevertheless, the net effect was to increase stroke volume. Measurement of M&f1;O2 demonstrated that at a given ventricular volume, M&f1;O2 did not change with DCC; however, peak ventricular pressure increased substantially, so that the effective pressure-volume area increased. CONCLUSIONS: Biventricular DCC can augment end-systolic pressure with no added costs of M&f1;O2. Under ejecting conditions, this augmentation of ventricular contracting ability manifests as increases in stroke volume. Thus, DCC represents a feasible alternative form of ventricular assist, and devices that support the heart in this manner should be further explored.


Subject(s)
Heart/physiology , Hemodynamics/physiology , Myocardial Contraction/physiology , Stroke Volume/physiology , Animals , Blood Pressure , Dogs , In Vitro Techniques , Male , Shock, Cardiogenic/physiopathology , Systole , Ventricular Function , Ventricular Function, Right/physiology
4.
Ann Thorac Surg ; 65(2): 340-5, 1998 Feb.
Article in English | MEDLINE | ID: mdl-9485226

ABSTRACT

BACKGROUND: Pulmonary vascular resistance is often elevated in patients with congestive heart failure, and in those undergoing left ventricular assist device (LVAD) insertion, it may precipitate right ventricular failure and hemodynamic collapse. Because the effectiveness of inotropic and vasodilatory agents is limited by systemic effects, right ventricular assist devices are often required. Inhaled nitric oxide (NO) is an effective, specific pulmonary vasodilator that has been used successfully in the management of pulmonary hypertension. METHODS: Eleven of 23 patients undergoing LVAD insertion met criteria for elevated pulmonary vascular resistance on weaning from cardiopulmonary bypass (mean pulmonary artery pressure > 25 mm Hg and LVAD flow rate < 2.5 L x min[-1] x m[-2]) and were randomized to receive either inhaled NO at 20 ppm (n = 6) or nitrogen (n = 5). Patients not manifesting a clinical response after 15 minutes were given the alternative agent. RESULTS: Hemodynamics for the group at randomization were as follows: mean arterial pressure, 72 +/- 6 mm Hg; mean pulmonary artery pressure, 32 +/- 4 mm Hg; and LVAD flow, 2.0 +/- 0.3 L x min(-1) x m(-2). Patients receiving inhaled NO exhibited significant reductions in mean pulmonary artery pressure and increases in LVAD flow, whereas none of the patients receiving nitrogen showed hemodynamic improvement. Further, when the nitrogen group was subsequently given inhaled NO, significant hemodynamic improvements ensued. There were no significant changes in mean arterial pressure in either group. CONCLUSIONS: Inhaled NO induces significant reductions in mean pulmonary artery pressure and increases in LVAD flow in LVAD recipients with elevated pulmonary vascular resistance. We conclude that inhaled NO is a useful intraoperative adjunct in patients undergoing LVAD insertion in whom pulmonary hypertension limits device filling and output.


Subject(s)
Heart-Assist Devices , Hypertension, Pulmonary/drug therapy , Nitric Oxide/administration & dosage , Vasodilator Agents/administration & dosage , Administration, Inhalation , Blood Pressure/drug effects , Cardiopulmonary Bypass , Double-Blind Method , Female , Heart Failure/complications , Humans , Hypertension, Pulmonary/complications , Hypertension, Pulmonary/physiopathology , Male , Middle Aged , Pulmonary Artery , Vascular Resistance/drug effects
5.
J Am Coll Cardiol ; 30(7): 1773-7, 1997 Dec.
Article in English | MEDLINE | ID: mdl-9385906

ABSTRACT

OBJECTIVES: Our recent experience with outpatient left ventricular assist device (LVAD) support is presented to demonstrate the possibilities and limitations of long-term outpatient mechanical circulatory assistance. BACKGROUND: The experience with inpatient LVAD support as a bridge to transplantation has proved the efficacy of such therapy in improving circulatory hemodynamic status, restoring normal end-organ function and facilitating patient rehabilitation. With miniaturization of the power supplies and controllers, such mechanical circulatory support can now be accomplished in an outpatient setting. METHODS: Between March 1993 and February 1997, 32 patients (26 male, 6 female, mean [+/-SEM] age 49 +/- 15 years) underwent implantation of the ThermoCardiosystems (TCI) Heartmate vented electric (VE) LVAD. The VE LVAD is powered by batteries worn on shoulder holsters and is operated by a belt-mounted system controller, allowing unrestricted patient ambulation and hospital discharge. RESULTS: Mean duration of support was 122 +/- 26 days (range 3 to 605), with a survival rate to transplantation or explantation of 78%. Nineteen patients were discharged from the hospital on mean postoperative day 41 +/- 4 (range 17 to 68), for an outpatient support time of 108 +/- 30 days (range 2 to 466). Four patients underwent early transplantation and could not participate in the discharge program, and three patients currently await discharge. The complication rate was not statistically different from that encountered in our previous 52 patients with a pneumatic LVAD. CONCLUSIONS: Outpatient LVAD support is safe and provides improved quality of life for patients awaiting transplantation. Wearable and totally implantable LVADs should be studied as permanent treatment options for patients who are not candidates for heart transplantation.


Subject(s)
Heart Failure/therapy , Heart Transplantation , Heart-Assist Devices , Ambulatory Care , Equipment Design , Female , Heart Failure/mortality , Humans , Male , Middle Aged , Patient Discharge , Patient Selection , Survival Rate , Time Factors
6.
J Thorac Cardiovasc Surg ; 114(4): 627-34, 1997 Oct.
Article in English | MEDLINE | ID: mdl-9338649

ABSTRACT

OBJECTIVES: Right-sided circulatory failure resulting from severe preoperative pulmonary hypertension is a source of mortality early after cardiac transplantation. We undertook the present study (1) to analyze the association of elevated pulmonary hemodynamic indices with 30-day mortality, (2) to define threshold ranges associated with an increase in 30-day mortality, and (3) to evaluate the effect of vasodilator reversibility on 30-day mortality. METHODS: Preoperative hemodynamic profiles were evaluated in 476 patients who ultimately underwent cardiac transplantation. From these data, receiver-operating characteristic curves and stratum-specific likelihood ratios were generated to compare the efficacy of each hemodynamic index. A subset of patients with elevated hemodynamic profiles at baseline additionally underwent graded sodium nitroprusside infusion. RESULTS: Analysis of receiver-operating characteristic curves demonstrated no statistically significant difference among the indices in their ability to predict 30-day mortality. Analysis of stratum-specific likelihood ratios demonstrated three risk strata that correlated with significant differences in 30-day mortality, with patients in the high-risk stratum having a 3.2 to 4.4 increase in odds of 30-day mortality when compared with patients in the low-risk stratum. Nitroprusside data demonstrated that although 30-day mortality was better in patients with reversible pulmonary hypertension than in those with fixed pulmonary hypertension, it was not comparable with that of patients without pulmonary hypertension at baseline. CONCLUSIONS: Candidates for cardiac transplantation may be categorized into three risk strata on the basis of their preoperative pulmonary hemodynamic profile; the association of this profile with 30-day mortality is not linear. Reversibility with nitroprusside appears to confer some improvement in the risk of 30-day mortality, but it may not eliminate the risk entirely.


Subject(s)
Heart Transplantation/mortality , Hypertension, Pulmonary/epidemiology , Cardiac Catheterization , Case-Control Studies , Cohort Studies , Female , Humans , Hypertension, Pulmonary/drug therapy , Likelihood Functions , Logistic Models , Male , Middle Aged , Nitroprusside/therapeutic use , Pulmonary Circulation/drug effects , Pulmonary Circulation/physiology , ROC Curve , Retrospective Studies , Risk Factors , Time Factors , Vasodilator Agents/therapeutic use
7.
J Heart Lung Transplant ; 16(8): 822-31, 1997 Aug.
Article in English | MEDLINE | ID: mdl-9286774

ABSTRACT

BACKGROUND: Mechanical cardiac assistance has recently emerged as a tenable option in the treatment of end-stage heart failure. In spite of recent technical improvements that have reduced the incidence of life-threatening complications, the reported frequency of infections in these patients has remained high. METHODS: Over a 5-year period, 60 patients underwent insertion of a left ventricular assist device (LVAD) at our institution. Detailed medical records were kept prospectively for all patients, and a variety of endpoints were analyzed, including the incidence, nature, and sequelae of infections before and after LVAD implantation and after transplantation. RESULTS: Twenty-nine of 60 patients (48%) undergoing LVAD insertion subsequently had development of infections. The most frequent sites of infection were blood, LVAD drivelines, and central venous catheters, representing 61% of all infections. At the time of LVAD implantation, 13 of 60 patients (22%) had culture-proven infections. In spite of an increased incidence of subsequent infection (77% vs 40%), there were no differences in rates of mortality (31% vs 26%), LVAD endocarditis, (23% vs 11%) and eventual transplantation (62% vs 57%) between these patients and those without periimplantation infections. Although the overall mortality rate was not influenced by infections during LVAD support (28% vs 26%), the development of LVAD endocarditis was associated with a high mortality rate. Finally, although patients with infections during LVAD support had significantly longer median support times than those who remained infection free (101 vs 49 days, respectively), there was no difference in the rate of successful transplantation (59% vs 58%) or in the rate of infection after transplantation (35% vs 28%). CONCLUSIONS: Infections are common in patients undergoing LVAD support, but they do not adversely affect survival, the rate of successful transplantation, or the incidence of posttransplantation infection. Periimplantation infections may increase the risk of subsequent infections, but they also do not influence survival or transplantability. Patients with development of LVAD endocarditis are at increased risk for morbidity and death and require early and aggressive therapy, potentially including device explantation.


Subject(s)
Cross Infection/mortality , Heart Failure/surgery , Heart Transplantation/mortality , Heart-Assist Devices , Opportunistic Infections/mortality , Postoperative Complications/mortality , Surgical Wound Infection/mortality , Adolescent , Adult , Aged , Cause of Death , Cross Infection/etiology , Endocarditis, Bacterial/etiology , Endocarditis, Bacterial/mortality , Female , Heart Failure/mortality , Humans , Male , Middle Aged , Opportunistic Infections/etiology , Postoperative Complications/etiology , Risk Factors , Surgical Wound Infection/etiology , Survival Analysis , Survival Rate
9.
J Thorac Cardiovasc Surg ; 113(6): 1091-9, 1997 Jun.
Article in English | MEDLINE | ID: mdl-9202690

ABSTRACT

OBJECTIVE: The purpose of this study was to quantify the magnitude of interaction between the right and left ventricles in conditions of heart failure. METHODS: Human hearts were taken from transplant recipients diagnosed with diluted cardiomyopathy at the time of transplantation and were restored to beating condition with use of an isolated perfusion circuit. Left ventricular-right ventricular interaction was determined by ramping volume in the left ventricle while holding right ventricular volume constant. Right ventricular pressure gain was plotted against left ventricular pressure and the slope of the linear regression determined the left ventricular-right ventricular interaction. A similar procedure was used to determine right ventricular-left ventricular interaction. Two normal hearts were obtained from transplant donors not suitable for cardiac donation to serve as control hearts. RESULTS: Mean left ventricular-right ventricular interaction was 0.22 in the hearts with dilated cardiomyopathy compared with 0.06 in the control hearts. Mean right ventricular-left ventricular interaction was 0.14 in the hearts with dilated cardiomyopathy compared with 0.09 in the control hearts. A marked increase in left ventricular-right ventricular interaction was noted in the hearts with dilated cardiomyopathy compared with control hearts. Although observed values of right ventricular-left ventricular interaction also correspond to previously published results, no significant increase was observed in the dilated cardiomyopathy condition. CONCLUSIONS: These studies confirm previously published values for systolic ventricular interaction obtained with animal models and demonstrate a marked increase in the dependence of the right ventricle on left ventricular function to maintain systolic pressure generation during conditions of dilated cardiomyopathy.


Subject(s)
Cardiomyopathy, Dilated/physiopathology , Heart/physiology , Ventricular Function , Cardiomyopathy, Dilated/surgery , Elasticity , Heart Transplantation , Humans , In Vitro Techniques , Linear Models , Systole , Ventricular Function, Left , Ventricular Function, Right , Ventricular Pressure
11.
Circulation ; 95(7): 1844-52, 1997 Apr 01.
Article in English | MEDLINE | ID: mdl-9107172

ABSTRACT

BACKGROUND: If long-term use of left ventricular assist devices (LVADs) as bridges to transplantation is successful, the issue of permanent device implantation in lieu of transplantation could be addressed through the creation of appropriately designed trials. Our medium-term experience with both pneumatically and electrically powered ThermoCardiosystems LVADs is presented to outline the benefits and limitations of device support in lieu of transplantation. METHODS AND RESULTS: Detailed records were kept prospectively for all patients undergoing LVAD insertion. Fifty-eight LVADs were inserted over 5 years, with a survival rate of 74%. Mean patient age was 50 years, and duration of support averaged 98 days. Although common, both preexisting infection and infection during LVAD support were not associated with increased mortality or decreased rate of successful transplantation. Thromboembolic complications were rare, occurring in only three patients (5%) despite the absence of anticoagulation. Ventricular arrhythmias were well tolerated in all patients except in cases of early perioperative right ventricular failure, with no deaths. Right ventricular failure occurred in one third of patients and was managed in a small percentage by right ventricular assist device (RVAD) support and/or inhaled nitric oxide therapy. There were no serious device malfunctions, but five graft-related hemorrhages resulted in two deaths. Finally, a variety of noncardiac surgical procedures were performed in LVAD recipients, with no major morbidity and mortality. CONCLUSIONS: Over all, our medium-term experience with implantable LVAD support is encouraging. Although additional areas of investigation exist, improvements in patients selection and management together with device alterations that have reduced the thromboembolic incidence and facilitated patient rehabilitation lead us to believe that a prospective, randomized trial is indicated to study the role that LVADs may have as an alternative to medical management.


Subject(s)
Assisted Circulation , Heart Failure/surgery , Heart Transplantation , Heart-Assist Devices , Prostheses and Implants , Aged , Arrhythmias, Cardiac/etiology , Assisted Circulation/economics , Assisted Circulation/instrumentation , Assisted Circulation/rehabilitation , Cardiomyopathies/complications , Combined Modality Therapy , Comorbidity , Cost-Benefit Analysis , Endocarditis/epidemiology , Endocarditis/etiology , Equipment Design , Female , Follow-Up Studies , Heart Failure/complications , Heart Failure/economics , Heart-Assist Devices/economics , Hemorrhage/etiology , Hemorrhage/mortality , Humans , Infections/epidemiology , Length of Stay , Male , Middle Aged , Nitric Oxide/therapeutic use , Postoperative Complications/epidemiology , Prospective Studies , Survival Analysis , Thromboembolism/epidemiology
12.
J Heart Lung Transplant ; 16(4): 449-53, 1997 Apr.
Article in English | MEDLINE | ID: mdl-9154956

ABSTRACT

BACKGROUND: Whether increased cardiac output during chronic circulatory support with a left ventricular assist device (LVAD) is associated with improved metabolic vasodilation in the peripheral circulation of patients with congestive heart failure is unknown. METHODS: Forearm blood flow, determined by venous occlusion plethysmography, mean arterial pressure, and cardiac output were measured at rest and after 5 minutes of arterial occlusion (a maximal metabolic vasodilatory stimulus) in 14 patients with severe heart failure before LVAD implantation, and in the early (<4 weeks) and late (8 to 12 weeks) postoperative recovery phases after LVAD implantation. Nine normal subjects served as controls. Vascular conductance was calculated as the ratio of forearm blood flow and mean arterial pressure. RESULTS: Mean arterial pressure and cardiac output increased to normal values in the early and late recovery phases after LVAD implantation. Resting forearm blood flow and vascular conductance were similar to normal subjects in the early and late recovery phases after LVAD implantation. Peak forearm blood flow and vascular conductance were significantly less than control subjects in the early preoperative recovery phase (p < 0.05) but were similar to control subjects in the late postoperative recovery phase after LVAD implantation. CONCLUSIONS: In spite of early normalization of cardiac output, mean arterial pressure, and resting forearm blood flow during chronic circulatory support with the LVAD, peak forearm blood flow, and peak vascular conductance did not increase to values similar to those observed in normal subjects until the late postoperative recovery period. The delayed effect of the LVAD on metabolic vasodilation may be related to flow-dependent changes in the peripheral vasculature of patients with heart failure.


Subject(s)
Energy Metabolism/physiology , Heart Failure/surgery , Heart-Assist Devices , Shock, Cardiogenic/surgery , Vasodilation/physiology , Adolescent , Adult , Aged , Blood Pressure/physiology , Cardiac Output/physiology , Exercise Test , Female , Forearm/blood supply , Heart Failure/physiopathology , Hemodynamics/physiology , Humans , Male , Middle Aged , Postoperative Complications/physiopathology , Shock, Cardiogenic/physiopathology , Ventricular Function, Left/physiology
13.
Circulation ; 95(5): 1122-5, 1997 Mar 04.
Article in English | MEDLINE | ID: mdl-9054839

ABSTRACT

BACKGROUND: The hypotension of septic shock is due to systemic vasodilation. On the basis of a clinical observation, we investigated the possibility that a deficiency in vasopressin contributes to the vasodilation of septic shock. METHODS AND RESULTS: In 19 patients with vasodilatory septic shock (systolic arterial pressure [SAP] of 92 +/- 2 mm Hg [mean +/- SE], cardiac output [CO] of 6.8 +/- 0.7 L/min) who were receiving catecholamines, plasma vasopressin averaged 3.1 +/- 1.0 pg/mL. In 12 patients with cardiogenic shock (SAP, 99 +/- 7 mm Hg; CO, 3.5 +/- 0.9 L/min) who were also receiving catecholamines, it averaged 22.7 +/- 2.2 pg/mL (P < .001). A constant infusion of exogenous vasopressin to 2 patients with septic shock resulted in the expected plasma concentration, indicating that catabolism of vasopressin is not increased in this condition. Although vasopressin is a weak pressor in normal subjects, its administration at 0.04 U/min to 10 patients with septic shock who were receiving catecholamines increased arterial pressure (systolic/diastolic) from 92/52 to 146/66 mm Hg (P < .001/P < .05) due to peripheral vasoconstriction (systemic vascular resistance increased from 644 to 1187 dyne.s/cm5; P < .001). Furthermore, in 6 patients with septic shock who were receiving vasopressin as the sole pressor, vasopressin withdrawal resulted in hypotension (SAP, 83 +/- 3 mm Hg), and vasopressin administration at 0.01 U/min, which resulted in a plasma concentration (approximately 30 pg/mL) expected for the level of hypotension, increased SAP from 83 to 115 mm Hg (P < .01). CONCLUSIONS: Vasopressin plasma levels are inappropriately low in vasodilatory shock, most likely because of impaired baroreflex-mediated secretion. The deficiency in vasopressin contributes to the hypotension of vasodilatory septic shock.


Subject(s)
Hemodynamics , Shock, Cardiogenic/physiopathology , Shock, Septic/physiopathology , Vasodilation , Vasopressins/deficiency , Adult , Blood Pressure , Cardiac Output , Dopamine/blood , Epinephrine/blood , Heart Rate , Humans , Norepinephrine/blood , Shock, Cardiogenic/blood , Shock, Septic/blood , Sodium/blood , Vascular Resistance , Vasopressins/blood
14.
Ann Thorac Surg ; 64(6): 1757-62; discussion 1762-3, 1997 Dec.
Article in English | MEDLINE | ID: mdl-9436568

ABSTRACT

BACKGROUND: Over the past decade, the use of mechanical circulatory support in patients with postcardiotomy cardiogenic shock has resulted in hospital discharge rates of 25% to 40%. In an attempt to improve patient survival, we initiated a program of early insertion of an implantable Thermocardiosystems Incorporated Heartmate left ventricular assist device in patients who have circulatory failure after having undergone high-risk cardiac operations. METHODS: Between April 1993 and February 1997, 12 patients underwent insertion of an implantable left ventricular assist device for postcardiotomy cardiogenic shock after coronary artery bypass grafting. Indications for insertion included postoperative cardiogenic shock (7 patients), postoperative cardiac arrest (3 patients), and failure to wean from cardiopulmonary bypass (2 patients). RESULTS: The median time to device insertion was 3.5 days. The mean duration of left ventricular assist device support was 103 +/- 19 days (range, 2 to 225 days). Nine of 11 patients (82%) survived to undergo either transplantation (8 patients) or explantation (1 patient), with successful hospital discharge of all 9 patients. The major complication was device-related infection (42%). A single thromboembolism occurred in a patient with an infection. CONCLUSIONS: Long-term outcome after postcardiotomy cardiogenic shock is improved substantially with the use of an implantable left ventricular assist device early in the postoperative course. Access to such a device is an important consideration before undertaking a high-risk cardiac operation, and early implantation of the device is a critical factor in ensuring long-term survival.


Subject(s)
Cardiac Surgical Procedures/adverse effects , Heart-Assist Devices , Shock, Cardiogenic/therapy , Algorithms , Female , Heart-Assist Devices/adverse effects , Humans , Male , Middle Aged , Shock, Cardiogenic/etiology , Time Factors , Treatment Outcome
15.
J Heart Lung Transplant ; 15(11): 1151-7, 1996 Nov.
Article in English | MEDLINE | ID: mdl-8956124

ABSTRACT

BACKGROUND: Left ventricular assist devices have become an important tool in the successful treatment of heart failure as bridges to transplantation. The optimal duration of device support before heart transplantation is debated. We report the effect of left ventricular device support duration on survival after heart transplantation. METHODS: All patients bridged to heart transplantation with the ThermoCardiosystems Heartmate 1,000 IP left ventricular assist device between January 1, 1986, and October 15, 1994, were included in our study. Parameters studied included duration of support, measures of end-organ function, and complications while supported with the device. Patients supported < 30 days were compared with patients supported > 30 days before undergoing transplantation. RESULTS: Patients supported for < 30 days had a threefold increased perioperative mortality compared with patients supported > 30 days (p = 0.031). Laboratory values of end-organ function were similar before left ventricular device insertion in both groups, although at the time of transplantation patients supported < 30 days had a significantly elevated bilirubin level compared with patients supported > 30 days (p < 0.001). Patients supported > 30 days had significantly more infections than the < 30 days group (p = 0.0345). CONCLUSIONS: Patients supported for > 30 days with left ventricular assist devices have improved post-transplant perioperative survival because of normalization of end-organ function and improved physiologic status secondary to aggressive physical rehabilitation. Patients should be supported for > 30 days in combination with physical rehabilitation, to improve early survival after heart transplantation.


Subject(s)
Heart Transplantation/physiology , Heart-Assist Devices , Tissue Survival/physiology , Adult , Female , Heart Transplantation/mortality , Heart Transplantation/statistics & numerical data , Heart-Assist Devices/adverse effects , Heart-Assist Devices/statistics & numerical data , Humans , Male , Middle Aged , Preoperative Care/statistics & numerical data , Retrospective Studies , Survivors , Time Factors
16.
Ann Thorac Surg ; 62(5): 1321-7; discussion 1328, 1996 Nov.
Article in English | MEDLINE | ID: mdl-8893563

ABSTRACT

BACKGROUND: A major limitation of cardiac assist devices has been the high incidence of thromboembolic events and their requirement for systemic anticoagulation. The Thermo Cardiosystems HeartMate 1000 IP left ventricular assist device (LVAD) employs a design that may reduce thromboembolic risk and obviate the need for systemic anticoagulation. METHODS: Two hundred twenty-three patients with nonreversible heart failure were supported with the HeartMate LVAD as a bridge to heart transplantation. All patients were monitored prospectively for thromboembolic events. Anticoagulation regimens and occurrence of subclinical thromboembolic events, including those seen by transcranial Doppler examinations in selected patients, were also recorded. RESULTS: Total time of LVAD support use was 531.2 patient-months. Twenty-three patients (10%) received warfarin postoperatively for 42.4 patient-months (8.2% of total support time). Six patients (2.7%) had thromboembolic events, representing 0.011 events per patient-month of device use. CONCLUSIONS: The thromboembolic complication rate associated with this LVAD is acceptably low despite the minimal anticoagulation employed in this series, allowing consideration of long-term device use for the treatment of heart failure.


Subject(s)
Heart Failure/surgery , Heart-Assist Devices/adverse effects , Thromboembolism/etiology , Adolescent , Adult , Aged , Anticoagulants/therapeutic use , Equipment Design , Female , Heart Transplantation , Humans , Incidence , Male , Middle Aged , Prospective Studies , Risk Factors , Thromboembolism/diagnostic imaging , Time Factors , Ultrasonography, Doppler, Transcranial , Waiting Lists
17.
Gen Hosp Psychiatry ; 18(6 Suppl): 30S-35S, 1996 Nov.
Article in English | MEDLINE | ID: mdl-8937921

ABSTRACT

Left ventricular assist devices (LVADs) driven by external sources and capable of sustaining life over weeks to months as a bridge to heart transplantation have been implanted in over 300 patients in the United States. Because of the limited availability of organs for transplantation, the remarkable degree to which LVADs reverse end-organ dysfunction, and patient acceptance, proposals for home LVAD treatment and for use of the LVAD as a permanent treatment for heart failure are being considered. LVAD therapy is associated with characteristic psychiatric and psychosocial problems, however, which must be addressed to optimize results. Among the first 30 LVAD patients treated at our center, psychiatric interventions were frequently required for family stress, major depression, organic mental syndromes, and serious adjustment disorders. Psychiatric problems most often occurred in patients with ongoing medical complications following LVAD implantation, and often significantly impaired rehabilitation. Both depression and organic mental syndromes were frequently associated with preexisting cerebrovascular disease, which was sometimes occult, and with strokes complicating LVAD therapy. Aggressive treatment of depression played a major role in improving functional status. LVADs may decompress heart transplant waiting lists and make it possible to optimize patients' physiological and functional status before transplantation. With increased LVAD use, however, neuropsychiatric factors can be expected to play a large role in determining quality of life and outcome both before and after heart transplantation.


Subject(s)
Cost of Illness , Heart Transplantation/psychology , Heart-Assist Devices/adverse effects , Mental Disorders/etiology , Waiting Lists , Activities of Daily Living , Adult , Aged , Female , Follow-Up Studies , Humans , Male , Mental Disorders/diagnosis , Mental Disorders/therapy , Middle Aged , Outcome Assessment, Health Care , Quality of Life , Referral and Consultation
18.
Ann Thorac Surg ; 62(3): 646-52; discussion 653, 1996 Sep.
Article in English | MEDLINE | ID: mdl-8783988

ABSTRACT

BACKGROUND: To evaluate the feasibility and efficacy of outpatient left ventricular assist devices as a bridge to transplantation, we reviewed the initial clinical experience with this modality at our institution. METHODS: During January 1993 to November 1995, 12 male and 2 female patients with an average age of 47 +/- 17 years were supported for an average of 117 +/- 24 days with the Thermo Cardiosystems VE wearable left ventricular assist device. Seven patients were discharged home an average of 35 +/- 4 days after implantation. RESULTS: No device failures occurred, although 29 controller malfunctions were identified during 1,640 total support days. All patients were able to safely maintain their devices. Outflow graft bleeding and driveline infection were responsible for two readmissions. No long-term anticoagulation treatment was used; one small thromboembolic episode occurred, but without significant long-term sequelae. CONCLUSIONS: None of the 7 patients released from the hospital died, and all were able to successfully maintain their devices at home. Hospital discharge of patients supported with left ventricular assist devices has allowed long-term evaluation of this technology, and the findings should prompt study of their use as a long-term alternative treatment to medical management for congestive heart failure.


Subject(s)
Ambulatory Care , Heart Transplantation , Heart-Assist Devices , Adolescent , Adult , Cardiac Output, Low/etiology , Cardiac Output, Low/therapy , Equipment Failure , Exercise Test , Feasibility Studies , Female , Heart-Assist Devices/adverse effects , Hemodynamics , Humans , Male , Middle Aged , Prostheses and Implants , Quality of Life , Time Factors
19.
J Heart Lung Transplant ; 15(8): 840-2, 1996 Aug.
Article in English | MEDLINE | ID: mdl-8998278

ABSTRACT

A 19-year-old man who had fulminant heart failure caused by an idiopathic dilated cardiomyopathy was supported with a left ventricular assist device for 183 days as a bridge to heart transplantation. At the time of intended transplantation it was noted that the patient's heart had returned to normal size, had a normal ejection fraction, and was able to maintain normal pressures and flows. In view of the apparent recovery of cardiac properties, the left ventricular assist device was explanted and the transplantation was not performed. However, the heart dilated, ejection fraction worsened, and the patient died of heart failure exacerbated acutely by a systemic viral illness. Although such recovery of systolic function is uncommon, as use of the left ventricular assist devices becomes more widespread other physicians might encounter similar findings and, in this regard, they might find our experience useful as they contemplate their treatment options.


Subject(s)
Cardiomyopathy, Dilated/therapy , Diastole/physiology , Heart-Assist Devices , Systole/physiology , Ventricular Dysfunction, Left/physiopathology , Adult , Cardiac Catheterization , Cardiomyopathy, Dilated/diagnosis , Cardiomyopathy, Dilated/physiopathology , Echocardiography, Doppler , Fatal Outcome , Humans , Male , Ventricular Dysfunction, Left/diagnosis , Ventricular Dysfunction, Left/therapy
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