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1.
J Heart Lung Transplant ; 19(2): 121-6, 2000 Feb.
Article in English | MEDLINE | ID: mdl-10703686

ABSTRACT

BACKGROUND: Left ventricular assist devices (LVAD) have been used successfully as a life-sustaining bridge to transplantation in adults with end-stage heart failure. Long-term implantable cardiac assist devices for smaller adolescent patients are not yet available in the United States. METHODS: This study reviews the experience with patients less than 21 years old that received HeartMate LVADs (TCI) at our institution. Twelve patients were implanted with 13 LVADs. The patients ranged in age from 11 to 20 years (mean 16 years). Body surface area ranged from 1.4 to 2.2 m2 (mean 1.8 m2). Patients were selected for LVAD placement based on eligibility for heart transplant and evidence of end-organ dysfunction. Device placement in small patients was facilitated with prosthetic graft abdominal wall closure. No patient received systemic anticoagulation. RESULTS: The duration of LVAD support ranged from 0 to 397 days (mean 123 days). Seven of the 8 patients eligible for discharge from the hospital with a vented-electric LVAD were supported at home while awaiting transplantation. Outcomes of LVAD support were: LVAD explantation in 2 cases (15%), expiration with LVAD in place in 3 cases (23%), and successful transplantation in 8 cases (62%). Complications included 4 patients with systemic infection, 3 re-operations for hemorrhage, 1 embolic event, and 1 intraoperative air embolus that proved fatal. One explanted patient required a subsequent LVAD and the other expired 4 months after explantation. Six of the 8 transplanted patients are alive and well with follow-up ranging from 8 to 43 months. CONCLUSIONS: Adolescent patients with heart failure can be successfully supported on a long-term basis to heart transplantation with the HeartMate LVAD. The wearable device allows for discharge home while awaiting transplantation. Device explantation without subsequent transplantation can be unpredictable. The incidence of thromboembolism remains low despite the absence of systemic anticoagulation. The technique of prosthetic graft closure of the abdominal wall facilitates the use of this device in smaller patients.


Subject(s)
Heart Transplantation , Heart-Assist Devices , Adolescent , Adult , Cardiomyopathies/surgery , Cardiomyopathy, Hypertrophic/surgery , Child , Female , Humans , Male , Retrospective Studies
2.
J Thorac Cardiovasc Surg ; 119(2): 251-9, 2000 Feb.
Article in English | MEDLINE | ID: mdl-10649200

ABSTRACT

OBJECTIVE: With increasing numbers of implantations, left ventricular assist device programs can put a financial strain on a hospital unless an efficient and safe outpatient program is developed. However, the left ventricular assist device is not widely recognized in the medical community as being reliable enough to support a patient at home. We reviewed our experience with these patients at home to assess the safety and the benefits of such a program. METHODS: Our institutional 6-year experience with 90 consecutive recipients of a wearable left ventricular assist device was analyzed. RESULTS: Forty-four (49%) of the 90 patients who received TCI vented-electric left ventricular assist devices (Thermo Cardiosystems, Inc, Woburn, Mass) were discharged, spending a total of 4546 days (12.5 years) at home with an average of 103 +/- 16 days of outpatient support (range 9-436 days). Of these 44 patients, all were successfully bridged to transplantation (42 patients, 96%) or planned explantation (2 patients, 4%). None of the outpatients died. The cumulative events per outpatient month were 0.020 for bleeding, 0.053 for device infection, 0.0068 for thromboembolus, and 0.020 for major malfunctions. Our estimated average cost to bridge a patient to transplantation or explantation once discharged is $13,200 and as an inpatient over the same length of time, including only room and board, is $165,200. Thirty percent of outpatients were able to return to work or school, 33% to sexual activity, and 44% to driving. All outpatients performed activities of daily living. CONCLUSION: Current left ventricular assist device technology provides effective and economical outpatient support and is associated with limited morbidity and a satisfactory quality of life.


Subject(s)
Ambulatory Care/economics , Heart Failure/therapy , Heart-Assist Devices , Outpatients , Ambulatory Care/standards , Cost-Benefit Analysis , Female , Follow-Up Studies , Heart-Assist Devices/economics , Heart-Assist Devices/standards , Humans , Male , Middle Aged , Quality of Life , Recurrence , Retrospective Studies , Safety , Treatment Outcome
3.
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
4.
J Am Coll Cardiol ; 33(7): 1903-8, 1999 Jun.
Article in English | MEDLINE | ID: mdl-10362191

ABSTRACT

OBJECTIVES: Implantation of left ventricular assist devices (LVADs) early after acute myocardial infarction (MI) has traditionally been thought to be associated with high mortality rates due to technical limitations and severe end-organ dysfunction. At some experienced centers, doctors have refrained from earlier operation after MI to allow for a period of hemodynamic and end-organ stabilization. METHODS: We retrospectively investigated the effect of preoperative MI on the survival rates of 25 patients who received a Thermocardiosystems Incorporated LVAD either <2 weeks (Early) (n = 15) or >2 weeks (Late) (n = 10) after MI. Outcome variables included perioperative right ventricular assistance (and right-sided circulatory failure), hemodynamic indexes, percent transplanted or explanted, and mortality. RESULTS: No statistically significant differences were demonstrated between demographic, perioperative or hemodynamic variables between the Early and Late groups. Patients in the Early group demonstrated a lower rate of perioperative mechanical right ventricular assistance, but had a higher rate of perioperative inhaled nitric oxide use. In addition, 67% of patients in the Early group survived to transplantation and 7% to explantation, findings comparable to those in the Late group (60% and 0% respectively). CONCLUSIONS: This clinical experience suggests that patients may have comparable outcomes whether implanted early or late after acute MI. These data therefore support the early identification and timely application of this modality in post-MI LVAD candidates, as this strategy may also reveal a subgroup of patients for whom post-MI temporary LVAD insertion may allow for full ventricular recovery.


Subject(s)
Heart-Assist Devices , Myocardial Infarction/mortality , Myocardial Infarction/therapy , Prosthesis Implantation , Adult , Aged , Follow-Up Studies , Hemodynamics , Humans , Middle Aged , Myocardial Infarction/physiopathology , Prognosis , Retrospective Studies , Survival Rate
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 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
7.
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
8.
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
9.
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
10.
ASAIO J ; 42(5): M576-9, 1996.
Article in English | MEDLINE | ID: mdl-8944946

ABSTRACT

Since 1986, the HeartMate left ventricular assist system (LVAS) has been widely used as a bridge to transplantation. Recently, a multicenter study was undertaken to evaluate the safety of allowing patients supported by the vented electric (VE) LVAS to await transplantation at home. Eligible patients progressed from 1 day to 3 day passes, then were discharged from the hospital. Twenty-nine patients at four centers were evaluated for incidence of adverse events and change in quality of life. Mean time of support was 193.7 +/- 138 days (range, 35-504 days). Patients spent a total of 2,922 days at home: 344 1 day passes and 150 3 day passes were issued; 21 patients were discharged from the hospital. There were 15 readmissions to the hospital: 9 for medical reasons and 6 for device related problems. Patients were able to resolve numerous technical problems at home. No deaths occurred outside of the hospital. Two patients returned to full-time employment, and all patients resumed an active lifestyle. Although adverse events occurred, the results of this study appear to demonstrate that patients may safely await transplantation at home while supported by a HeartMate VE-LVAS.


Subject(s)
Heart-Assist Devices , Adolescent , Adult , Aged , Ambulatory Care , Cardiomyopathies/rehabilitation , Cardiomyopathies/surgery , Clinical Protocols , Female , Heart Transplantation , Heart-Assist Devices/adverse effects , Humans , Infections/etiology , Male , Middle Aged , Quality of Life , Thromboembolism/etiology , Time Factors
11.
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
12.
ASAIO J ; 42(3): 150-3, 1996.
Article in English | MEDLINE | ID: mdl-8725680

ABSTRACT

Left ventricular assist devices effectively improve hemodynamic function and reverse renal and hepatic dysfunction; however, their effects upon the gastrointestinal (Gl) system have not been addressed. We evaluated Gl function in 27 left ventricular assist device recipients using interviews, Gl contrast studies, endoscopy, and 99mTc sulfur colloid studies of esophageal transit and gastric emptying. While on left ventricular assist device support (mean duration of 84 days), 19 patients reported early satiety and/or nausea, and 1 was unable to tolerate oral intake. Esophageal transit time (normal, < 10 sec) was borderline slow at 14 +/- 4 (mean +/- standard error of the mean) and gastric emptying (normal < 90 min) was prolonged (range of 106-506 min, mean = 283 +/- 69 min). In a 1-38 month follow-up, gastric function subjectively improved in all. Six patients had intraperitoneal device placement. One died of aspiration pneumonia secondary to small bowel obstruction, and one had prolonged inability to tolerate oral intake, which required feeding jejunostomy tube placement. The 21 patients with pre peritoneal placement of the device did not require Gl operative interventions and had no catastrophic Gl events; they had mild to no Gl complaints. Pre peritoneal placement may mitigate early satiety and obviate serious Gl complications.


Subject(s)
Gastric Emptying/physiology , Gastrointestinal Diseases/etiology , Gastrointestinal Transit/physiology , Heart-Assist Devices/adverse effects , Digestive System Physiological Phenomena , Endoscopy, Gastrointestinal , Heart-Assist Devices/standards , Hemodynamics/physiology , Humans , Isotope Labeling , Postoperative Complications , Retrospective Studies , Severity of Illness Index , Technetium
13.
J Heart Lung Transplant ; 15(4): 423-9, 1996 Apr.
Article in English | MEDLINE | ID: mdl-8732603

ABSTRACT

BACKGROUND: As early perioperative survival with left ventricular assist device support improves, additional emphasis must be placed on patient rehabilitation. Especially as mean left ventricular assist device support times exceed 100 days, it is essential for health professionals to mobilize patients to prevent the incidence of the deleterious effects of bedrest. The timing of optimal functional performance and the safety of rehabilitation has not been described. METHODS: We retrospectively studied patients surviving left ventricular assist device implantation (34 of 41 patients; 27 men, 7 women; age 51 +/- 11 years). Physical therapy consisted of progressive mobilization leading to treadmill exercise or cycling. All patients exercised in the "pump on full" mode with flows >or= 3.0 L/min. RESULTS: Twenty of thirty-four patients initiated ambulation at 7 to 10 days with independent ambulation by 14 days in 55% of the group. Treadmill exercise was tolerated by 82% of the patients, begun at postoperative day 21 by eighteen patients. The greatest improvement in exercise performance was seen by 6 to 8 weeks (20 to 30 minutes at 3.17 +/- 0.79 metabolic equivalents). Maximal functional capacity achieved was influenced by medical complications. A total of 1878 treatment sessions lasting 1390 hours was performed. Only four minor incidents occurred representing 2.9 incidents/1000 patient hours; all involved a transient decrease in pump flow. None of these events resulted in an increase in morbidity or mortality. CONCLUSIONS: Progressive mobilization in patients with left ventricular assist device is safe. Patients return to independence in activities of daily living and tolerate prolonged workloads of up to 5 metabolic equivalents. There is rapid improvement in functional capacity until 6 weeks after operation. Delay in transplantation until this time may optimize postoperative recovery.


Subject(s)
Early Ambulation , Exercise Therapy , Heart Failure/rehabilitation , Heart Transplantation , Heart-Assist Devices , Activities of Daily Living , Exercise Tolerance , Female , Humans , Male , Middle Aged , Retrospective Studies , Time Factors
14.
Circulation ; 92(9 Suppl): II169-73, 1995 Nov 01.
Article in English | MEDLINE | ID: mdl-7586403

ABSTRACT

BACKGROUND: Although use of long-term implantable left ventricular assist devices (LVAD) is becoming more popular, further reduction of the mortality rate accompanying device insertion through improved patient selection would make this alternative even more appealing. We sought to develop a scoring system that was based on criteria obtainable at the time of evaluation and predictive of successful early outcome and simple to apply. METHODS AND RESULTS: Patients (n = 56) undergoing LVAD insertion between 1990 and 1994 were screened for easily obtainable preoperative risk factors. To test the association between survival and each risk factor, a chi 2 analysis was performed, and relative risks were estimated. Oliguria, ventilator dependence, elevated central venous pressure, elevated prothrombin time, and reoperation stats had low probability values and high estimated relative risks. On the basis of these relations, a risk factor-selection scale (RFSS) (range, 0 to 10) was developed by computing appropriate weights for each risk factor. The distribution of patients for each scale score reveal that with RFSS > or = 5, most device recipients will die (P < .001). The average RFSS (+/- SD) of survivors (n = 42) was 2.45 +/- 1.73 compared with 5.43 +/- 2.85 in nonsurvivors (n = 14) (P < .0001). Univariate logistical regression was also significant (score statistic, 16.2; df = 1; P = .001). CONCLUSIONS: The RFSS is simple, easy to apply, and statistically valid. Physicians could use the scale as a starting point in discussing the suitability for LVAD implantation in a specific patient and as a basis for comparing patient outcomes.


Subject(s)
Heart Diseases/classification , Heart-Assist Devices , Patient Selection , Ventricular Function, Left , Adolescent , Adult , Aged , Chi-Square Distribution , Female , Humans , Logistic Models , Male , Middle Aged , Prognosis , Prostheses and Implants , Risk Factors , Survival Analysis
15.
Ann Surg ; 222(2): 203-7, 1995 Aug.
Article in English | MEDLINE | ID: mdl-7639586

ABSTRACT

OBJECTIVE: The authors describe their experience with left ventricular assist-device (LVAD) recipients undergoing noncardiac surgery and delineate surgical, anesthetic, and logistic factors important in the successful intraoperative management of these patients. SUMMARY BACKGROUND DATA: Left ventricular assist-devices have become part of the armamentarium in the treatment of end-stage heart failure. As the numbers of patients chronically supported with long-term implantable devices grows, general surgical problems that are commonly seen in other hospitalized patients are becoming manifest. Of particular interest is the intraoperative management of patients undergoing elective noncardiac surgical procedures. METHODS: The anesthesia records and clinical charts were reviewed for eight ventricular assist-device recipients undergoing general surgical procedures between August 1, 1990 and August 31, 1994. RESULTS: A total of 12 procedures were performed in 6 men and 2 women averaging 52.7 years of age. Mean time elapsed from device implantation to operation was 68 +/- 35 days. Conventional inhalational and intravenous anesthetic techniques were well tolerated in these patients undergoing diverse surgical procedures. No perioperative mortality was observed. Five of eight patients went on to successful cardiac transplantation. CONCLUSIONS: Hemodynamic recovery after LVAD insertion has defined a new group of patients who develop noncardiac surgical problems often seen in other critically ill patients. Recognition of the unique potential problems that the LVAD recipient may encounter in the perioperative period--in particular patient positioning, device limitations, and fluid and inotropic management--will ensure an optimal surgical outcome for LVAD recipients undergoing noncardiac surgery.


Subject(s)
Heart-Assist Devices , Intraoperative Care , Surgical Procedures, Operative , Adult , Aged , Anesthesia, Endotracheal , Anesthesia, Intravenous , Blood Loss, Surgical , Female , Fluid Therapy , Heart Rate , Heart Transplantation , Humans , Male , Middle Aged , Monitoring, Intraoperative , Postoperative Complications , Posture , Survival Rate , Treatment Outcome , Ventricular Function, Left
16.
ASAIO J ; 41(3): M277-80, 1995.
Article in English | MEDLINE | ID: mdl-8573805

ABSTRACT

Left ventricular assist devices can be successfully used in the pediatric population if currently available devices are used appropriately. To highlight their management strategies, the authors' experience with pediatric left ventricular assist devices is reviewed, with case studies documenting options for device use. A retrospective study was conducted for all patients supported at the authors' institutions. Nine pediatric patients received devices during this time, with ages ranging from 12 days to 15 years. There was considerable size differences in our patients, with weights ranging between 2.5 and 73 kg. Either the Abiomed BVS 5000 (Abiomed Cardiovascular, Inc, Danvers, MA) or the Biomedicus centrifugal pump (Bio-Medicus, Inc, Eden Prairie, MN) were used for all patients. Patients were supported for an average of 5 days (range 1-11 days). Eight patients were successfully weaned from the device, with four undergoing transplant. Four patients were discharged and are long-term survivors, and one is still recovering post transplant. Neurologic sequelae were the most common complications in these patients, with four patients having events. Pediatric ventricular assist devices are limited because of size considerations, although current devices can be successfully used for bridging to recovery or transplantation. New devices are needed to meet the flow and size characteristics for pediatric patients. Successful use of assist devices, as has been recognized in adults, is possible in pediatric patients if these requirements are met.


Subject(s)
Heart-Assist Devices , Adolescent , Adult , Cardiac Output , Cardiomyopathy, Dilated/therapy , Child , Evaluation Studies as Topic , Female , Heart Transplantation , Heart-Assist Devices/adverse effects , Hemorrhage/etiology , Humans , Infant , Infant, Newborn , Male , Nervous System Diseases/etiology , Retrospective Studies , Shock, Cardiogenic/therapy , Thromboembolism/etiology , Time Factors
17.
Ann Thorac Surg ; 59(5): 1063-7; discussion 1068, 1995 May.
Article in English | MEDLINE | ID: mdl-7537489

ABSTRACT

Aprotinin, a bovine protease inhibitor, has been used extensively in patients undergoing cardiac surgical procedures in an effort to minimize blood loss and prevent the complications associated with blood replacement. We sought to evaluate the effect of aprotinin on postoperative blood loss, renal function, and the incidence of right ventricular failure in patients undergoing placement of a TCI Heartmate left ventricular assist device as a bridge to cardiac transplantation. Retrospective data analysis in 142 patients (42 receiving aprotinin and 100 untreated) demonstrated that the use of aprotinin was associated with a significant decrease in postoperative blood loss (p = 0.019) and in the intraoperative packed red blood cell transfusion (p = 0.019) and total blood product (p = 0.016) requirements. A transient, yet significant, increase in the postoperative creatinine level in the aprotinin group (p = 0.0006), but not in blood urea nitrogen level (p = 0.22), was noted. Interestingly, we noted an association between blood loss and the subsequent development of right ventricular failure; patients who required a right ventricular assist device bled significantly more than did those who did not suffer right ventricular failure (p = 0.02). Additionally, aprotinin recipients benefited by a reduction of nearly one half in the incidence of the need for a right ventricular assist device. The incidence of perioperative mortality was reduced in those receiving aprotinin compared with that in untreated patients, (p = 0.05). We conclude that aprotinin is safe and effective in decreasing postoperative blood loss and intraoperative blood product requirements, and in reducing perioperative mortality in patients undergoing left ventricular assist device placement as a bridge to cardiac transplantation.


Subject(s)
Aprotinin/administration & dosage , Blood Loss, Surgical/prevention & control , Blood Transfusion , Heart-Assist Devices , Postoperative Complications/mortality , Adult , Blood Urea Nitrogen , Creatinine/blood , Female , Humans , Male , Retrospective Studies , Ventricular Function, Right
18.
J Heart Lung Transplant ; 14(1 Pt 1): 186-91, 1995.
Article in English | MEDLINE | ID: mdl-7727468

ABSTRACT

BACKGROUND: Despite advances in the perioperative treatment of both heart transplant and left ventricular assist device recipients, right-sided circulatory failure refractory to medical management remains a major source of morbidity in the immediate postoperative period. In addition, hypervolemia is a frequent complication encountered in the treatment of these patients because of their large fluid intake requirements and relative potential for kidney failure. METHODS: Previous reports have documented the use of continuous-flow devices to support the failing right-sided circulation of patients after both left ventricular assist device insertion and orthotopic heart transplantation. However, such continuous-flow devices may carry the attendant risks of hemolysis and bleeding and may further require 24-hour monitoring by trained personnel. We report the temporary-use pulsatile Abiomed BVS 5000 right ventricular assist device and continuous arteriovenous hemodialysis in the recipient of a pulsatile TCI HeartMate 1000 IP left ventricular assist device both after left ventricular assist device implantation and after orthotopic heart transplantation. RESULTS: The patient was well at 13 months follow-up. CONCLUSIONS: The use of right ventricular assist devices and continuous arteriovenous hemodialysis in both transplant and left ventricular assist device recipients undoubtedly will remain important as the popularity of these two therapeutic modalities continues to grow.


Subject(s)
Heart Failure/therapy , Heart Transplantation , Heart-Assist Devices , Postoperative Complications/therapy , Renal Dialysis/methods , Ventricular Dysfunction, Right/therapy , Equipment Design , Humans , Male , Middle Aged , Pulsatile Flow/physiology
19.
J Am Coll Cardiol ; 24(7): 1688-91, 1994 Dec.
Article in English | MEDLINE | ID: mdl-7963116

ABSTRACT

OBJECTIVES: We sought to quantitate the incidence of malignant ventricular arrhythmias and to identify subsequent hemodynamic changes and untoward events in patients who have received an implantable left ventricular circulatory assist device as an extended bridge to heart transplantation. BACKGROUND: Implantable long-term mechanical circulatory assist devices have been used clinically with increasing frequency and success for the past 4 years. Previous investigators have suggested that patients with malignant ventricular arrhythmias receiving a left ventricular assist device will require both left and right ventricular assistance to maintain vital organ perfusion. METHODS: We reviewed our 4-year experience with 21 patients who underwent implantation of a left ventricular assist device. Device flows and mean arterial pressure were used to assess systemic perfusion; central venous pressure provided a gauge of right ventricular function. Charts were screened for evidence of end-organ injury resulting from malignant ventricular arrhythmias. RESULTS: Malignant ventricular arrhythmias occurred in 4 patients (19%) before device placement and in 9 patients (43%) during device support. The latter nine patients formed the final study group; their arrhythmias occurred 0 to 186 days after device implantation and had a duration of 10 min to 12 days. The patients reported weakness or palpitation; however, none reported syncope or dyspnea. Mean arterial pressure and central venous pressure were insignificantly changed by the arrhythmias. Device flow decreased by 1.4 +/- 0.6 liters/min (p < 0.05) at the onset of the arrhythmias but returned to normal after cardioversion. No thromboembolic events or significant end-organ dysfunction occurred. CONCLUSION: Absence of right ventricular contraction during malignant ventricular arrhythmias is well tolerated in recipients of a left ventricular assist device. The diagnosis of malignant arrhythmia should be suspected if an unexplained decrease in left ventricular assist device flow occurs. Early electrical cardioversion is warranted to avoid both thrombus formation in the native heart and right ventricular myocardial injury from prolonged fibrillation.


Subject(s)
Cardiomyopathy, Dilated/surgery , Heart-Assist Devices , Tachycardia, Ventricular/physiopathology , Ventricular Fibrillation/physiopathology , Adolescent , Adult , Cardiomyopathy, Dilated/physiopathology , Female , Hemodynamics , Humans , Male , Middle Aged , Postoperative Complications/physiopathology , Stroke Volume , Tachycardia, Ventricular/etiology , Treatment Outcome , Ventricular Fibrillation/etiology
20.
Ann Thorac Surg ; 58(5): 1515-20, 1994 Nov.
Article in English | MEDLINE | ID: mdl-7979685

ABSTRACT

Left ventricular assist devices (LVADs) increasingly are being used as a bridge to transplantation. We studied changes in New York Heart Association class, mean arterial pressure, resting cardiac output, end-organ function, exercise oxygen consumption, and exercise cardiac output in 12 LVAD recipients. In addition, resting levels of neurohormonal factors were evaluated 4 to 16 weeks after implantation. Two of the 12 patients died of right heart failure and 1 of aspiration; all deaths occurred in the first 2 weeks after LVAD implantation. Of the other 9 patients, 8 improved to New York Heart Association class I and 1 to class II, all of whom were in class IV preoperatively. The 4 patients who underwent exercise testing achieved an exercise oxygen consumption of 15.0 +/- 2.7 mL.kg-1.min-1, which was paralleled by an increase in resting cardiac output from 3.07 +/- 0.9 L.min-1 preoperatively to 5.66 +/- 1.1 L.min-1 at 2 months, and mean arterial pressure from 60 +/- 8 to 91 +/- 10 mm Hg at 2 months, a benefit that was maintained for up to 10 months. End-organ function revealed comparable improvement at 2 months for both creatinine (1.68 +/- 0.7 to 1.0 +/- 0.19 mg.dL-1) and total bilirubin (1.37 +/- 1.17 to 0.54 +/- 0.26 mg.dL-1) levels. Levels of neurohormones were within normal limits. Adverse clinical events after the perioperative period were minimal, and no thromboembolic complications occurred.(ABSTRACT TRUNCATED AT 250 WORDS)


Subject(s)
Ambulatory Care , Heart-Assist Devices , Adolescent , Adult , Aged , Female , Heart-Assist Devices/adverse effects , Hemodynamics , Humans , Male , Middle Aged , Patient Selection , Waiting Lists
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