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P M Portner

Publications and source records attributed to P M Portner.

At least 19 recordsLinked to original sources
PubMed2006

Effect of age on outcomes after left ventricular assist device placement.

The influence of age on outcomes after left ventricular assist device (LVAD) implantation is not well studied. To address this question, we assessed 222 patients who underwent LVAD placement and were divided into quartiles based on age (years): group 1, or=60. Eighty-four patients died on LVAD support. Six- and 12-month survivals for the four groups of LVAD patients were 67.7, 73.7, 49.8, and 38.2, and 49.4, 57.3, 42.7, and 26.2, respectively (all P<.01). Older patients showed a higher risk of infections, embolic strokes, and respiratory complications. They were the least likely to undergo reoperations postimplantation (56%, 53%, 50%, 46%, P=.06). After adjusting for baseline differences between the groups, there was a trend toward increasing mortality with age, which did not reach significance (odds ratio 1.93; 95% confidence interval 0.95 to 3.92 for the oldest quartile as compared with the youngest). In conclusion, these results suggest in the absence of other high risk factors, age alone should not be used as an independent contraindication for LVAD implantation.

Adult↗
PubMed2001

Mechanical circulatory support for advanced heart failure: effect of patient selection on outcome.

BACKGROUND: Use of wearable left ventricular assist systems (LVAS) in the treatment of advanced heart failure has steadily increased since 1993, when these devices became generally available in Europe. The aim of this study was to identify in an unselected cohort of LVAS recipients those aspects of patient selection that have an impact on postimplant survival. METHODS AND RESULTS: Data were obtained from the Novacor European Registry. Between 1993 and 1999, 464 patients were implanted with the Novacor LVAS. The majority had idiopathic (60%) or ischemic (27%) cardiomyopathy; the median age at implant was 49 (16 to 75) years. The median support time was 100 days (4.1 years maximum). Forty-nine percent of the recipients were discharged from the hospital on LVAS; they spent 75% of their time out of the hospital. For a subset of 366 recipients, for whom a complete set of data was available, multivariate analysis revealed that the following preimplant conditions were independent risk factors for survival after LVAS implantation: respiratory failure associated with septicemia (odds ratio 11.2), right heart failure (odds ratio 3.2), age >65 years (odds ratio 3.01), acute postcardiotomy (odds ratio 1.8), and acute infarction (odds ratio 1.7). For patients without any of these factors, the 1-year survival after LVAS implantation including the posttransplantation period was 60%; for the combined group with at least 1 risk factor, it was 24%. CONCLUSIONS: Careful selection, specifically implantation before patients become moribund, and improvement of management may result in improved outcomes of LVAS treatment for advanced heart failure.

Adolescent↗
PubMed2001

Improved outcomes with an implantable left ventricular assist system: a multicenter study.

BACKGROUND: Cumulative experience with the Novacor wearable electric left ventricular assist system (LVAS) now exceeds 850 recipients. The pump inflow conduit (IFC) has been implicated in embolic complications. METHODS: Clinical outcomes were compared for two IFC designs in a retrospective, nonrandomized, multicenter study. The original IFC (woven, unsupported, crimped polyester: control group) and an alternative IFC (knitted, gelatin-sealed, integrally supported, uncrimped polyester: test group) were utilized upon availability in North American and European centers. Differences in cerebral embolism to 180 days postimplant were analyzed. RESULTS: Four hundred ninety patients implanted between August 1996 and August 1999, were studied. Two hundred eighty-eight received the control IFC and 202 received the test IFC. The groups (control, test) were well matched for age (48, 49 years), etiology (idiopathic 53%[152 of 288], 55% [112 of 202]; ischemic 34% [97 of 288], 33% [66 of 202]) and mean observation time (97, 91 days). The incidence of embolic cerebrovascular accidents (CVA) was 21% (60 of 288) in the control and 12% (24 of 202) in the test group (p = 0.010). Independent risk factors for embolic CVA were found to be preimplant acute myocardial infarction (odds ratio 4.3), age above 50 years (odds ratio 2.1), and ischemic etiology (odds ratio 1.7). There was no difference in survival between the groups (71% [205 of 288], 68% [137 of 202]). CONCLUSIONS: The alternative (test) IFC has significantly reduced the incidence of embolic CVA. This improvement is likely due to increased resistance to deformation at implant, improved neointimal adhesion, and more favorable blood flow characteristics within the conduit.

Cardiomyopathies↗
PubMed2001

Economics of devices.

BACKGROUND: The economics of devices used for mechanical circulatory support not only involve the patient, the provider, and society as a whole, but also, importantly, the developers and manufacturers of these new technologies. The combined effects of years of development and testing with significant regulatory, reimbursement, and acceptance barriers make this a capital-intensive and high-risk endeavor. In addition, long-term circulatory support is, today, essentially limited to bridge to transplantation, a "market" of only $100 million. Competition is increasing, with new devices under development and entering clinical trials. CONCLUSIONS: Economic health for this new industry is dependent on expanding clinical indications to definitive or destination therapy, and perhaps other applications such as bridge to recovery and assisted medical therapies.

Costs and Cost Analysis↗
PubMed2001

The totally implantable novacor left ventricular assist system.

The Novacor Left Ventricular Assist System (LVAS) (Novacor Corp, Oakland, CA) was initially console-based and has been available since 1993 in a wearable configuration. It has been successfully used for the past 16 years as a bridge to cardiac transplantation in patients with end-stage congestive heart failure. The Stanford experience represents 53 patients (48 male, 5 female) with a mean age of 44 +/- 13 years (16 to 62) and a mean support time of 56 +/- 76 days (1 to 374). Complications with LVAS use consisted predominantly of bleeding (43%), infection, (30%), and embolic cerebrovascular events (24.5%). Sixty-six percent of the supported patients were successfully bridged to cardiac transplantation. In animal studies, 4 sheep had the totally implantable configuration in place for a cumulative duration of 1 year with 1 animal supported for 260 days. The next generation Novacor LVAS will be small, quiet, and fully implantable without the need for volume compensation. It will also provide physiologic pulsatile flow and will be fail-safe.

Adolescent↗
PubMed2001

The Novacor left ventricular assist system: clinical experience from the Novacor registry.

The electrically powered Novacor left ventricular assist (LVAS) system was first used clinically as a bridge to transplant in 1984. The configuration has evolved to the current wearable model used clinically for the first time in 1993. In 1998, the inflow conduit was modified, reducing embolic events by 50%. Over 1100 implants have been performed worldwide with cumulative support greater than 300 patient years, and only 0.7% requiring replacement. The Novacor is a safe and effective device for bridge to transplant, bridge to recovery, or potentially permanent implant with reliable long-term support for periods as long as 4 years.

Adolescent↗
PubMed2000

Long-term mechanical circulatory support with the wearable Novacor left ventricular assist system.

OBJECTIVE: As of July 1st 1999, 36 European patients have lived for more than 1 year supported by the Novacor wearable electric left ventricular assist system (LVAS). All were unresponsive to maximum medical therapy, prior to implantation. These patients offer an unique opportunity to evaluate the feasibility of long-term ambulatory mechanical circulatory support as a therapeutic option for patients in profound cardiac failure. METHODS: Data was obtained from the Novacor European Registry. RESULTS: At the time of implantation, median age was 55 (18-67) years. Aetiology was ischemic (9, 25%) or idiopathic (26, 72%) cardiomyopathy, and myocarditis (1, 3%). Median duration of LVAS support was 1.49 (1. 03-4.10) years. Eight recipients had LVAS support times >2 years, of which two were >3 years and one >4 years. The median time spent outside the hospital was 1.27 (0.58-3.83) years, representing 82% of the duration of LVAS support. No mechanical failure was observed during the entire observation period. One pump was replaced electively after 3.67 years due to pump driver wear-out. Twelve patients (33%) are currently on support while 17 were transplanted (14, 39%) or weaned (3, 8%). Seven (19%) patients died after a median of 1.24 years circulatory support. CONCLUSIONS: Experience with long-term Novacor LVAS recipients has demonstrated effective rehabilitation in this group of patients with refractory advanced heart failure. This suggests that LVAS therapy may offer a safe and realistic option for patients for whom no other effective therapy is available. The patient sub-population that would benefit most from this therapy remains to be defined.

Adolescent↗
PubMed1998

Long-term mechanical circulatory support system reliability recommendation: American Society for Artificial Internal Organs and The Society of Thoracic Surgeons: long-term mechanical circulatory support system reliability recommendation.

Jointly developed by members of the American Society for Artificial Internal Organs and the Society of Thoracic Surgeons along with staff from the Food and Drug Administration, the National Heart, Lung and Blood Institute and other experts, this recommendation describes the reliability considerations and goals for Investigational Device Exemption and Premarket Approval submissions for long-term, mechanical circulatory support systems. The recommendation includes a definition of system failure, a discussion of an appropriate reliability model, a suggested in vitro reliability test plan, reliability considerations for animal implantation tests, in vitro and animal in vivo performance goals, the qualification of design changes during the Investigational Device Exemption clinical trial, the development of a Failure Modes Effects and Criticality Analysis, and the reliability information for surgeons and patient candidates. The document will be periodically reviewed to assess its timeliness and appropriateness within five years.

Animals↗
PubMed1991

Clinical experience with the Novacor ventricular assist system. Bridge to transplantation and the transition to permanent application.

At Stanford University, a Novacor left ventricular assist system (Baxter Healthcare Corporation, Novacor Division, Oakland, Calif.) was placed as a bridge to heart transplantation in 13 patients. During the hospitalization preceding device implantation, all patients were receiving inotropic support for biventricular failure, 11 had pulmonary edema, 6 had life-threatening ventricular arrhythmias, 5 had liver dysfunction with coagulopathy, and 2 had renal failure necessitating artificial support. The mean cardiac index before implantation of the Novacor system was 1.5. All survivors with the Novacor device had a dramatic increase in cardiac output (mean cardiac index = 3.1). One patient with cardiac allograft rejection died during implantation of the left ventricular assist system. Two patients died of pulmonary sepsis and multiorgan failure after the device was implanted. All patients who had the Novacor device implanted for more than 7 days were able to walk and ride stationary bicycles while awaiting transplantation. Ten patients (77%) underwent successful heart transplantation after a mean of 18 days' support with the Novacor device. One patient died of presumed sepsis 2 days after transplantation. Nine patients (90%) are alive 4 months to 6 years after transplantation. In the overall United States experience, 68 patients (as of May 1990) have had a Novacor left ventricular assist device implanted. Five were still being supported, 39 had received a transplant (62%), and 35 patients (90%) survived the transplant hospitalization (1 died later). No instances of device failure have occurred. Overall, the Novacor assist system provided effective bridging to transplantation, with posttransplant survival similar to results after routine transplantation. Modifications and improvements based on this clinical experience have been made in the areas of patient selection, techniques of operative placement, postoperative management, and design of the assist system. Isolated left heart support with a fully implantable left ventricular assist system will be offered as an alternative to heart transplantation for selected patients by 1992.

Adolescent↗
PubMed1989

Implantable electrical left ventricular assist system: bridge to transplantation and the future.

An implantable left ventricular assist system (LVAS) utilizing an electromechanically driven dual pusher-plate blood pump has been employed in a multiinstitutional trial as a bridge to cardiac transplantation. Under development for permanent circulatory support in patients with end-stage heart disease, the LVAS, in this application, derives power and control from an external console via a percutaneous lead. The LVAS was implanted in 20 patients (16 men, 4 women) who were hemodynamically unstable or in refractory cardiogenic shock. The mean age was 44.9 years (range, 25 to 63 years). Preoperative diagnosis was evenly divided between end-stage ischemic disease, cardiomyopathy, and acute myocardial infarction. Implanted in the left upper quadrant within the anterior abdominal wall, the blood pump was connected between the left ventricular apex and ascending aorta. Total support of the systemic circulation and substantial left ventricular unloading were achieved with synchronous counterpulsation for periods up to 90 days (mean, 22.7 days). All patients were stabilized hemodynamically. The mean preoperative cardiac index of 1.5 L/min/m2 increased by a factor of 2. Pulmonary arterial pressures decreased substantially. Serious complications occurred in 16 patients, precluding cardiac transplantation in 10. Most complications (greater than 70%) were in patients who did not receive transplants; the most common complication was bleeding. Twelve of 13 patients with LVAS implants for more than seven days were mobilized, and 4 were fully ambulatory and completely rehabilitated. Orthotopic cardiac transplantation was performed in 10 patients after implants ranging from two to 90 days (mean, 30.3 days).(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1988

Isolated left ventricular assist as bridge to cardiac transplantation.

The electrically driven Novacor implantable left ventricular assist device has been implanted in six patients (four men and two women) since Sept. 7, 1984. In four of the six patients (67%) the device was a successful bridge to cardiac transplantation. One patient died of multiple organ failure and Candida sepsis after 16 days of support with the device. One patient died in the operating room of uncontrollable hemorrhage and biventricular failure caused by severe cardiac rejection. Three patients are alive with cardiac transplants 38, 17, and 10 months after transplantation. One patient died after cardiac transplantation of presumed sepsis. The Novacor left ventricular assist device performed in all cases without mechanical or electrical failure. Excluding the intraoperative death, assist duration ranged from 2 to 16 days. The cardiac index (synonymous with device output) ranged from 2.4 to 3.4 L/min/m2. No embolic events (cerebrovascular or systemic) occurred during assistance with the device. Minimal red cell hemolysis was documented during the period of support. The Novacor left ventricular assist device is a safe and effective bridge to cardiac transplantation in patients with refractory cardiogenic shock.

Adult↗
PubMed1983

The blood interface at artificial surfaces within a left ventricular assist system.

A left ventricular assist system presents a very complex set of interfaces to the blood. The interactions of the various components, their junctions, and fluid dynamic effects have been discussed at a macroscopic, cellular and molecular level. Failure of any part of the system can seriously compromise LVAS function or host response whether due to gross thrombosis with occlusion, proliferative PNI formation, or thromboembolic events. It has been stated that: "When artificial hearts are designed properly, nearly any surface goes." Unfortunately, the blood interface within any circulatory support system, and indeed in much simpler systems, is a much more complex function than design, which includes the surface, materials and many other factors (Table 6).

Adsorption↗