The SynCardia Total Artificial Heart (TAH, SynCardia Systems, Tucson, AZ) is the only biventricul... more The SynCardia Total Artificial Heart (TAH, SynCardia Systems, Tucson, AZ) is the only biventricular cardiac replacement approved for bridge to transplantation by the U.S. Food and Drug Administration (FDA) and which carries the European Union CE mark. It has been implanted in about 2000 patients. In experienced centers, 60 to 80 % of implanted patients have been transplanted and over 80 % of those transplanted have lived for over 1 year. The SynCardia TAH has supported potential cardiac recipients with irreversible biventricular failure for up to 6 years, providing physiologic pulsatile flows of 6 to 8 L/min at filling pressures of less than 10 mmHg allowing for optimal perfusion and recovery of organs such as the kidneys and liver. It is a tested device that provides a method for recovering potential transplant candidates who rapidly decompensate from biventricular failure or who have chronic cardiac failure from a variety of etiologies. This article covers the history, mechanical ...
Mechanical circulatory support devices have been increasingly used for long-term support. We revi... more Mechanical circulatory support devices have been increasingly used for long-term support. We reviewed outcomes in all patients supported with a SynCardia total artificial heart (TAH) for more than 1 year to assess its safety in long-term support. As of December 2011, all 47 patients who received the TAH from 10 centers worldwide were included in this retrospective study. Clinical data were collected on survival, infections, thromboembolic and hemorrhagic events, device failures, and antithrombotic therapy. The mean age of patients was 50 ± 1.57 years, the median support time was 554 days (range 365-1373 days). The primary diagnosis was dilated cardiomiopathy in 23 patients, ischemic in 15, and "other" in 9. After a minimum of 1 year of support, 34 patients (72%) were successfully transplanted, 12 patients (24%) died while on device support, and 1 patient (2%) is still supported. Five patients (10%) had a device failure reported. Major complications were as follows: systemic infections in 25 patients (53%), driveline infections in 13 patients (27%), thromboembolic events in 9 patients (19%), and hemorrhagic events in 7 patients (14%). SynCardia TAH has proven to be a reliable and effective device in replacing the entire heart. In patients who reached a minimum of 1 year of support, device failure rate is acceptable and only in two cases was the leading cause of death. Infections and hemorrhagic events were the major causes of death. Patients who remain supported beyond 1 year are still likely to survive to transplantation.
BackgroundRecent evidence has demonstrated that transplantation of hearts with blood culture posi... more BackgroundRecent evidence has demonstrated that transplantation of hearts with blood culture positive donors (BCPDs) to pediatric recipients is safe and effective. Few studies have analyzed the effect of BCPD on adult heart transplant recipients.MethodsThe United Network for Organ Sharing (UNOS) database was retrospectively reviewed from September, 1987 to March, 2021. Exclusion criteria included pediatric donors/recipients, donor ejection fraction <10% or >85%, inactive listed recipients, donors missing blood cultures, and recipients missing follow‐up time. Outcomes were compared with fully adjusted logistic models. To account for discrepancies in BCPD and non‐BCPD covariates, an inverse proportionally weighted model with regression adjustment (IPWRA) was used.ResultsA total of 60 592 donors were non‐BCPD, while 4009 were BCPD. 7% of hearts not transplanted were BCPD, while 6% of hearts transplanted were BCPD (p = .001). These rates have been nearly constant since 2005. There...
The artificial heart has stirred considerable interest and controversy in the lay and medical pre... more The artificial heart has stirred considerable interest and controversy in the lay and medical press. The controversy arising from stroke complications and quality of life issues has stalled efforts to implant the device permanently. The clinical indications for the artificial heart are now largely limited to “bridge to transplantation.”
Three recent cases from one institution using the total artificial heart (TAH) before transplanta... more Three recent cases from one institution using the total artificial heart (TAH) before transplantation are reviewed. The first patient was implanted for 12 hours with the pneumatic Phoenix total artificial heart after failure of a donor heart 1 day after transplant. Following retransplantation the patient died from severe pulmonary edema, pulmonary hypertension, right ventricular failure, and Pseudomonas septicemia. The second patient was implanted with the Jarvik-7 total artificial heart for rapidly deteriorating idiopathic cardiomyopathy. Major complications during the 9 1/2-day implant consisted of severe pulmonary edema for the first 4 days and a multifocal cerebral embolic event on the seventh day after implantation from which he fully recovered. Major problems after transplant included disseminated toxoplasmosis and two mild episodes of rejection. The patient was discharged 68 days after surgery and remains well. The third patient was a 40-year-old woman with rapidly progressin...
The Cardio West Total Artificial Heart (TAH) is the only device in its class currently used world... more The Cardio West Total Artificial Heart (TAH) is the only device in its class currently used worldwide as a bridge to heart transplantation. It is a pneumatic device that totally replaces the failing ventricles. Patient selection criteria include: patient must be a transplant candidate; cardiac index (CI) 1.7m2; maximal inotropic support including the use of the intra-aortic balloon pump; and evidence of biventricular failure. A total of 79 patients have received the TAH in 10 centers around the world, with the intention to bridge to heart transplantation. The patient demographics include: 73 males, 6 females; average age 45 years (range 16–63 years); average BSA 1.94m2 (n = 59); average preoperative cardiac index (CI) 1.841 · min-1 · m-2 (n = 43); and average length of implantation 34 days (1–186 days). Fifty-five patients underwent heart transplantation, and 50 patients were eventually discharged home, 21 patients died on the device, and 3 patients remain on the TAH waiting to be transplanted. The overall survival of patients on the TAH is 66%, and 91% if the patient reaches transplantation. The most common cause of death while the patient is on the TAH is multiple organ failure. The survival rate with the Cardio West TAH is comparable with the survival rates of other mechanical assist devices currently available. This is the result of careful patient selection.
From March 1, 1979 thru September 30, 1984 we performed 56 cardiac transplants (Tx). The first 32... more From March 1, 1979 thru September 30, 1984 we performed 56 cardiac transplants (Tx). The first 32 patients received conventional immunosuppression therapy consisting of azathioprine/prednisone (I/P), while the subsequent 24 patients received cyclosporine/prednisone (C/P). Twenty-one of 32 I/P patients ages 39 +/- 3 years (SEM), and 16 of 24 eligible C/P patients ages 36 +/- 3 years, survived one year with follow-up through September 30, 1985. The one year post-transplant course of these 37 patients was evaluated by chart review. While donor ages are similar, ischemic time was shorter in the conventionally treated patients. The initial hospital stay for I/P vs C/P was 67 +/- 6 vs 33 +/- 3 days (p less than .05), at a total cost of $49,900 +/- $5,800 vs $53,800 +/- $10,000. During the first year following transplantation, the I/P patients required an additional 34 +/- 7 days of hospitalization, while C/P patients required 16 +/- 10 days. Over the first year, the number of infections and rejections differed at 2.8 +/- 0.6 per I/P patient vs 1.2 +/- 0.3 per C/P patient, and 2.5 +/- 0.4 per patient vs 1.5 +/- 0.3 per patient respectively (p less than .05). Renal function test results were better in the I/P group. Results of cardiac catheterization performed at one year were similar except for cardiac index and stroke volume index, both being higher in the C/P group. Coronary anatomy was considered normal in all. These data indicate that while overall survival is similar, a shortened post-transplant hospital course with fewer necessary hospitalizations, rejection episodes and infection episodes characterizes the first year in survivors receiving C/P immunosuppression. While both groups had multiple hemo-dynamic abnormalities as compared to normal subjects, cardiac index and stroke volume index were improved in the C/P group. Therapy with C/P represents an advance in immunosuppression for cardiac transplantation as compared to I/P; however, decreased renal function and diastolic hypertension were problems in the C/P group.
The SynCardia Total Artificial Heart (TAH, SynCardia Systems, Tucson, AZ) is the only biventricul... more The SynCardia Total Artificial Heart (TAH, SynCardia Systems, Tucson, AZ) is the only biventricular cardiac replacement approved for bridge to transplantation by the U.S. Food and Drug Administration (FDA) and which carries the European Union CE mark. It has been implanted in about 2000 patients. In experienced centers, 60 to 80 % of implanted patients have been transplanted and over 80 % of those transplanted have lived for over 1 year. The SynCardia TAH has supported potential cardiac recipients with irreversible biventricular failure for up to 6 years, providing physiologic pulsatile flows of 6 to 8 L/min at filling pressures of less than 10 mmHg allowing for optimal perfusion and recovery of organs such as the kidneys and liver. It is a tested device that provides a method for recovering potential transplant candidates who rapidly decompensate from biventricular failure or who have chronic cardiac failure from a variety of etiologies. This article covers the history, mechanical ...
Mechanical circulatory support devices have been increasingly used for long-term support. We revi... more Mechanical circulatory support devices have been increasingly used for long-term support. We reviewed outcomes in all patients supported with a SynCardia total artificial heart (TAH) for more than 1 year to assess its safety in long-term support. As of December 2011, all 47 patients who received the TAH from 10 centers worldwide were included in this retrospective study. Clinical data were collected on survival, infections, thromboembolic and hemorrhagic events, device failures, and antithrombotic therapy. The mean age of patients was 50 ± 1.57 years, the median support time was 554 days (range 365-1373 days). The primary diagnosis was dilated cardiomiopathy in 23 patients, ischemic in 15, and &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot;other&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot; in 9. After a minimum of 1 year of support, 34 patients (72%) were successfully transplanted, 12 patients (24%) died while on device support, and 1 patient (2%) is still supported. Five patients (10%) had a device failure reported. Major complications were as follows: systemic infections in 25 patients (53%), driveline infections in 13 patients (27%), thromboembolic events in 9 patients (19%), and hemorrhagic events in 7 patients (14%). SynCardia TAH has proven to be a reliable and effective device in replacing the entire heart. In patients who reached a minimum of 1 year of support, device failure rate is acceptable and only in two cases was the leading cause of death. Infections and hemorrhagic events were the major causes of death. Patients who remain supported beyond 1 year are still likely to survive to transplantation.
BackgroundRecent evidence has demonstrated that transplantation of hearts with blood culture posi... more BackgroundRecent evidence has demonstrated that transplantation of hearts with blood culture positive donors (BCPDs) to pediatric recipients is safe and effective. Few studies have analyzed the effect of BCPD on adult heart transplant recipients.MethodsThe United Network for Organ Sharing (UNOS) database was retrospectively reviewed from September, 1987 to March, 2021. Exclusion criteria included pediatric donors/recipients, donor ejection fraction <10% or >85%, inactive listed recipients, donors missing blood cultures, and recipients missing follow‐up time. Outcomes were compared with fully adjusted logistic models. To account for discrepancies in BCPD and non‐BCPD covariates, an inverse proportionally weighted model with regression adjustment (IPWRA) was used.ResultsA total of 60 592 donors were non‐BCPD, while 4009 were BCPD. 7% of hearts not transplanted were BCPD, while 6% of hearts transplanted were BCPD (p = .001). These rates have been nearly constant since 2005. There...
The artificial heart has stirred considerable interest and controversy in the lay and medical pre... more The artificial heart has stirred considerable interest and controversy in the lay and medical press. The controversy arising from stroke complications and quality of life issues has stalled efforts to implant the device permanently. The clinical indications for the artificial heart are now largely limited to “bridge to transplantation.”
Three recent cases from one institution using the total artificial heart (TAH) before transplanta... more Three recent cases from one institution using the total artificial heart (TAH) before transplantation are reviewed. The first patient was implanted for 12 hours with the pneumatic Phoenix total artificial heart after failure of a donor heart 1 day after transplant. Following retransplantation the patient died from severe pulmonary edema, pulmonary hypertension, right ventricular failure, and Pseudomonas septicemia. The second patient was implanted with the Jarvik-7 total artificial heart for rapidly deteriorating idiopathic cardiomyopathy. Major complications during the 9 1/2-day implant consisted of severe pulmonary edema for the first 4 days and a multifocal cerebral embolic event on the seventh day after implantation from which he fully recovered. Major problems after transplant included disseminated toxoplasmosis and two mild episodes of rejection. The patient was discharged 68 days after surgery and remains well. The third patient was a 40-year-old woman with rapidly progressin...
The Cardio West Total Artificial Heart (TAH) is the only device in its class currently used world... more The Cardio West Total Artificial Heart (TAH) is the only device in its class currently used worldwide as a bridge to heart transplantation. It is a pneumatic device that totally replaces the failing ventricles. Patient selection criteria include: patient must be a transplant candidate; cardiac index (CI) 1.7m2; maximal inotropic support including the use of the intra-aortic balloon pump; and evidence of biventricular failure. A total of 79 patients have received the TAH in 10 centers around the world, with the intention to bridge to heart transplantation. The patient demographics include: 73 males, 6 females; average age 45 years (range 16–63 years); average BSA 1.94m2 (n = 59); average preoperative cardiac index (CI) 1.841 · min-1 · m-2 (n = 43); and average length of implantation 34 days (1–186 days). Fifty-five patients underwent heart transplantation, and 50 patients were eventually discharged home, 21 patients died on the device, and 3 patients remain on the TAH waiting to be transplanted. The overall survival of patients on the TAH is 66%, and 91% if the patient reaches transplantation. The most common cause of death while the patient is on the TAH is multiple organ failure. The survival rate with the Cardio West TAH is comparable with the survival rates of other mechanical assist devices currently available. This is the result of careful patient selection.
From March 1, 1979 thru September 30, 1984 we performed 56 cardiac transplants (Tx). The first 32... more From March 1, 1979 thru September 30, 1984 we performed 56 cardiac transplants (Tx). The first 32 patients received conventional immunosuppression therapy consisting of azathioprine/prednisone (I/P), while the subsequent 24 patients received cyclosporine/prednisone (C/P). Twenty-one of 32 I/P patients ages 39 +/- 3 years (SEM), and 16 of 24 eligible C/P patients ages 36 +/- 3 years, survived one year with follow-up through September 30, 1985. The one year post-transplant course of these 37 patients was evaluated by chart review. While donor ages are similar, ischemic time was shorter in the conventionally treated patients. The initial hospital stay for I/P vs C/P was 67 +/- 6 vs 33 +/- 3 days (p less than .05), at a total cost of $49,900 +/- $5,800 vs $53,800 +/- $10,000. During the first year following transplantation, the I/P patients required an additional 34 +/- 7 days of hospitalization, while C/P patients required 16 +/- 10 days. Over the first year, the number of infections and rejections differed at 2.8 +/- 0.6 per I/P patient vs 1.2 +/- 0.3 per C/P patient, and 2.5 +/- 0.4 per patient vs 1.5 +/- 0.3 per patient respectively (p less than .05). Renal function test results were better in the I/P group. Results of cardiac catheterization performed at one year were similar except for cardiac index and stroke volume index, both being higher in the C/P group. Coronary anatomy was considered normal in all. These data indicate that while overall survival is similar, a shortened post-transplant hospital course with fewer necessary hospitalizations, rejection episodes and infection episodes characterizes the first year in survivors receiving C/P immunosuppression. While both groups had multiple hemo-dynamic abnormalities as compared to normal subjects, cardiac index and stroke volume index were improved in the C/P group. Therapy with C/P represents an advance in immunosuppression for cardiac transplantation as compared to I/P; however, decreased renal function and diastolic hypertension were problems in the C/P group.
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