Mechanical cardiac support 2000: current applications and future trial design. June 15-16, 2000 Bethesda, Maryland.
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Equipment Design↗
Biomedical subjects
M C Oz
Publications and source records attributed to M C Oz.
Surgical issues in heart failure: what's new?
Despite major advances in inotropic medications and our understanding of their proper use, surgical management of heart failure is the fastest-growing aspect of cardiovascular surgery. In addition to causing 750,000 deaths annually, myocardial infarctions leave an estimated 60,000 more patients in severe congestive heart failure and several times more individuals with compromised ventricular function. As these patients are offered reparative surgical options, surgeons, anesthesiologists, and cardiologists face physiologic challenges that can be optimally overcome only by modifying treatment strategies to address patients who have failed appropriate medical therapy, including milrinone, vasopressin, and nitric oxide. As our comfort with mechanical support increases, the threshold for embarking on these lines of treatment will be altered. Innovative devices have been created to meet this clinical need, but they must provide adequate quality of life to create sustainable value and health for society.
Administration, Inhalation↗
Time course of reverse remodeling of the left ventricle during support with a left ventricular assist device.
BACKGROUND: Support with a left ventricular assist device leads to normalization of left ventricular chamber geometry, regression of myocyte hypertrophy, alterations in left ventricular collagen content, and normalized expression of genes involved with excitation-contraction coupling in patients with heart failure. The objective of this study was to investigate the time course of these processes. METHODS: Passive left ventricular pressure-volume relationships were obtained from explanted hearts of 19 patients with heart failure undergoing transplantation without left ventricular assist device support, 25 patients with heart failure supported before transplantation (duration of support ranging between 8 and 155 days), and 5 normal human hearts not suitable for transplantation. Left ventricular size was indexed by the volume at which left ventricular pressure reached 30 mm Hg. Left ventricular tissue samples were probed for sarcoplasmic endoreticular calcium adenosine triphosphatase 2a expression and processed for analysis of myocyte diameter and relative myocardial collagen content. RESULTS: The volume at which left ventricular pressure reached 30 mm Hg was not significantly different between hearts without and with assist device support for less than 40 days. However, the volume at which left ventricular pressure reached 30 mm Hg in patients with assist devices supported for more than 40 days was significantly smaller than that of the hearts without assist devices but was larger than that of normal hearts. A similar pattern was observed for myocyte diameter. Sarcoplasmic endoreticular calcium adenosine triphosphatase 2a expression increased to normal levels by about 20 days of support with an assist device. Relative collagen content was significantly increased in hearts supported for more than 40 days. CONCLUSION: Maximum structural reverse remodeling by left ventricular assist devices is complete by about 40 days. Molecular reverse remodeling of sarcoplasmic endoreticular calcium adenosine triphosphatase 2a expression is quicker, being complete by about 20 days.
Blotting, Northern↗
Circulatory support with a direct cardiac compression device: a less invasive approach with the AbioBooster device.
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Animals↗
Left ventricular volume reduction surgery for heart failure: a physiologic perspective.
BACKGROUND: Ventricular volume reduction surgery for idiopathic cardiomyopathy fails to improve cardiac output and is associated with a high incidence of recurrent heart failure. Volume reduction surgery achieved by removing akinetic or dyskinetic myocardium after myocardial infarction appears to be associated with better outcomes. The reasons for the differences in outcomes are not clear. METHODS AND RESULTS: The hemodynamic effect of the major forms of volume reduction surgery were predicted by using a composite model of the left ventricle in which 20% of the myocardium was given properties of either weak but contracting muscle, an akinetic scar, or a dyskinetic scar (aneurysm). The end-systolic and end-diastolic pressure-volume relationships were determined numerically for each simulated operation. Any volume reduction procedure reduced chamber size, shifting end-systolic and end-diastolic pressure-volume relationships leftward. With resection of weak but contracting muscle, the leftward shift was greater for the end-diastolic than for the end-systolic pressure-volume relationship. Conversely, with resection of dyskinetic scar, the leftward shift was greater for end-systolic than for end-diastolic pressure-volume relationships. In contrast, resection of stiff scar shifted the 2 relationships equally. The effect on overall pump function was indexed by the relationship between total ventricular mechanical work and end-diastolic pressure. There was a beneficial effect on this relationship of resecting dyskinetic tissue, an equivocal effect of akinetic scar resection, and a negative effect of removing contracting myocardium. CONCLUSIONS: The effect of volume reduction surgery on overall ventricular pumping characteristics is determined by the differential effects on end-systolic and end-diastolic properties, which in turn are determined by the material properties of the region being removed.
Cardiac Surgical Procedures↗
Multicenter clinical evaluation of the HeartMate vented electric left ventricular assist system in patients awaiting heart transplantation.
BACKGROUND: Despite advances in heart transplantation and mechanical circulatory support, mortality among transplant candidates remains high. Better ways are needed to ensure the survival of transplant candidates both inside and outside the hospital. METHODS: In a prospective, multicenter clinical trial conducted at 24 centers in the United States, 280 transplant candidates (232 men, 48 women; median age, 55 years; range, 11-72 years) unresponsive to inotropic drugs, intra-aortic balloon counterpulsation, or both, were treated with the HeartMate Vented Electric Left Ventricular Assist System (VE LVAS). A cohort of 48 patients (40 men, 8 women; median age, 50 years; range, 21-67 years) not supported with an LVAS served as a historical control group. Outcomes were measured in terms of laboratory data (hemodynamic, hematologic, and biochemical), adverse events, New York Heart Association functional class, and survival. RESULTS: The VE LVAS-treated and non-VE LVAS-treated (control) groups were similar in terms of age, sex, and distribution of patients by diagnosis (ischemic cardiomyopathy, idiopathic cardiomyopathy, and subacute myocardial infarction). VE LVAS support lasted an average of 112 days (range, < 1-691 days), with 54 patients supported for > 180 days. Mean VE LVAS flow (expressed as pump index) throughout support was 2.8 L x min(-1) x m(-2). Median total bilirubin values decreased from 1.2 mg/dL at baseline to 0.7 mg/dL (P =.0001); median creatinine values decreased from 1.5 mg/dL at baseline to 1.1 mg/dL (P =.0001). VE LVAS-related adverse events included bleeding in 31 patients (11%), infection in 113 (40%), neurologic dysfunction in 14 (5%), and thromboembolic events in 17 (6%). A total of 160 (58%) patients were enrolled in a hospital release program. Twenty-nine percent of the VE LVAS-treated patients (82/280) died before receiving a transplant, compared with 67% of controls (32/48) (P <.001). Conversely, 71% of the VE LVAS-treated patients (198/280) survived: 67% (188/280) ultimately received a heart transplant, and 4% (10/280) had the device removed electively. One-year post-transplant survival of VE LVAS-treated patients was significantly better than that of controls (84% [158/188] vs 63% [10/16]; log rank analysis P =.0197). CONCLUSION: The HeartMate VE LVAS provides adequate hemodynamic support, has an acceptably low incidence of adverse effects, and improves survival in heart transplant candidates both inside and outside the hospital. The studies of the HeartMate LVAS (both pneumatic and electric) for Food and Drug Administration approval are the only studies with a valid control group to show a survival benefit for cardiac transplantation.
Cohort Studies↗
A regional survey of health insurance coverage for complementary and alternative medicine: current status and future ramifications.
OBJECTIVE: The purpose of this survey is to evaluate the extent of health insurance coverage for complementary and alternative medicine (CAM) within one region in the United States, a study prompted by the increased utilization of CAM. DESIGN: Prospective telephone interview of health insurance representatives. LOCATION: A contiguous three-state area (New York, New Jersey, and Connecticut) in the North-east. RESULTS: Almost all of the insurers surveyed cover chiropractic services. Less than half of the insurers reimburse acupuncture, usually for chronic pain management. Coverage for massage therapy is minimal and usually associated with physical therapy or chiropractic treatment. Other CAM services receive negligible coverage. CONCLUSIONS: Current health insurance coverage of CAM is limited essentially to chiropractic medicine, acupuncture and massage therapy. Coverage of CAM is made confusing by different policies, practitioner requirements, and health plans within each carrier.
Acupuncture↗
Quantitative analysis of reproducible changes in high-voltage electrophotography.
OBJECTIVES: The existence of electromagnetic fields not generated by neuronal action or muscle stimulation remains controversial especially because they are difficulty to detect. We attempted to investigate the existence of electromagnetic fields associated with biologic systems using new image analysis techniques to analyze high-voltage electrophotography. DESIGN/SUBJECTS: Five energy practitioners (three males and two females) and five control subjects (four males and one female) participated in the study. Each practitioner had studied a formal training curriculum and was a professional energy practitioner. Images representing attempts of both energy practitioners and controls to elicit a change in electromagnetic emissions were captured by electrophotographic means. A statistical analysis on the comparison of "ON" vs. "OFF" states for the controls and practitioners in the study was made via digital representation of analogue images. RESULTS: Our interest was threefold: (1) to determine whether corona discharge patterns could be obtained and photographed and be reproducible; (2) to quantify some of the qualitative properties of the coronas; and (3) to determine if individuals can alter, at will, their electrophotographic images. We found a correlation between a change in the electromagnetic emissions for the body and the conscious desire of an energy practitioner to change this state. Analyses of individual finger coronas demonstrate statistically significant differences as analyzed by overall color changes and via analysis of individual sections of the various colors dominating the field. Control subjects were unable to produce statistically significant changes that were reproducible. Physiologic processes, such as changes in skin resistance, sweating, and surface blood constriction, have been suggested as an explanation of the colors and patterns that appear on the film in previous studies, but were not observed in this investigation. CONCLUSIONS: After controlling for the above variables and identifying reproducible and statistically significant changes, we believe the images created in our study represent the interaction of biologically generated electromagnetic fields interacting with the corona discharge created by the electrophotographic device.
Adult↗
The use of muscle flaps to treat left ventricular assist device infections.
Left ventricular assist devices have become an important adjunct in the therapeutic armamentarium for patients with end-stage heart failure. Although they may provide a bridge to transplantation, they are prone to certain problems, expecially infection. Because these are life-sustaining devices, changing the device or simple explantation may be a risky, if not impossible, option. Therefore, we evaluated the effectiveness of a surgical alternative, namely, coverage of infected devices with muscle or myocutaneous flaps. Eighty-two consecutive patients who underwent the insertion of 88 left ventricular assist devices at our institution over a 6.5-year period were evaluated. Follow-up was provided for all patients and ranged from 1 to 7.5 years. The duration of ventricular support ranged from 0 to 434 days. All patients who demonstrated clinical evidence of infection were identified. Overall, 54 patients (66 percent) had infections locally at the device site, at distant sites, or systemically during support. Cultured organisms included gram-positive and -negative bacteria, fungi, and viruses. Of the 56 infections in these 54 patients, 21 (38 percent) were device-related, i.e., in the pocket created by the device, in the device itself, or from the driveline. Thus, 24 percent (21 of 88) of all ventricular support devices inserted demonstrated device infection during use. Therapeutic modalities used to combat device-related infection included both nonsurgical management with antibiotics alone and surgical procedures such as device change or relocation, device explant, and flap coverage. Eight of the 20 patients in whom the 21 device-related infections occurred underwent surgical intervention. Four of these eight patients undenwent local flap coverage of their infected left ventricular assist devices. All four patients also had evidence of systemic infection, or "device endocarditis." Coverage was successfully achieved in all cases with pedicled rectus abdominis flaps. There were no perioperative complications. Two patients later underwent successful transplantation; the other two died from causes unrelated to the flap. In conclusion, the treatment of infected left ventricular assist devices currently includes both nonsurgical and surgical alternatives. Of the latter, muscle flaps should be considered a first-line intervention to assist in eradicating infection by providing well-vascularized tissue. Although there were no perioperative complications, the 50 percent mortality rate is consistent with that reported for patients with "device endocarditis." It may be that flap coverage of infected ventricular assist devices, if instituted at an earlier stage in the therapeutic process, could help prevent systemic infection in these patients and, therefore, improve their overall outcome.
Adolescent↗
Patient evaluation of the hotel function of hospitals.
BACKGROUND: A means of measuring patient satisfaction is essential in the effort to improve the quality of health care delivered in our nation's hospitals. Accurate feedback allows employers to better meet patients' needs and allows hospital administrators to improve service delivery. Patients are empowered by having a voice in the manner in which their health care is delivered. Moreover, improving the efficiency of the health care delivery system decreases health care costs. Hospital comparisons can be made readily available to a large audience through the Internet, resulting in empowerment of the patient and a universal improvement in hospital care. This is the first multi-institutional analysis of patient satisfaction among New York City and northern New Jersey area tertiary care hospitals. In this study, we evaluated the patient-assessed hotel function of hospitals in a single geographic region to determine whether clinically and statistically significant differences would be revealed that could provide beneficial information to stakeholders in the healthcare system. METHODS: Patients (n = 261) who had spent a night during the past year in one of eleven hospitals within 60 miles of New York City were chosen at random from doctors' waiting rooms. On average, 24 patients from each hospital were surveyed. They were asked to complete a questionnaire that rated the various departments in the hospital on qualities such as courtesy, promptness, and cleanliness. The questionnaire also rated important characteristics of the patient experience, such as the ease of parking and the taste of the food. Each item on the survey was coded on a scale of 1 to 10 with 10 being the most positive response. The 26 specific questions were divided into 14 domains. Averages in each domain were compared by gender, age, and hospital identity, attractiveness, and setting. All statistical calculations were performed using SPSS/PC, and means were compared using t-tests. RESULTS: Analysis designed to evaluate outcomes between each of the possible 54 pairs of hospitals comparisons revealed statistically significant differences as often as 44% of the time in some outcomes measures (logistics), but as rarely as 7% of the time in others (billing function). Clinically significant differences (>2 units per scale) were frequently evident, although the ranges differed dramatically depending on the domains surveyed. Although age, gender, and race/ethnicity were generally not predictive of satisfaction, non-urban setting was correlated with greater patient satisfaction. CONCLUSION: By having access to patient satisfaction comparisons among hospitals, patients are empowered to make better choices, employers can identify and adapt to patient preferences, and administrators can improve the services delivered and decrease health care costs by improving efficiency. Although our study was somewhat limited by patient selection biases, the study's results suggest that Internet-based tools of comparison will enable patients to make free and informed decisions about their health care by comparing local hospitals and voting on their impressions of the facilities from which they receive care.
Data Collection↗
A comparison of consecutive off-pump versus conventional coronary artery bypass.
BACKGROUND: Coronary revascularization on the beating heart is an attractive alternative to conventional coronary artery bypass grafts (CCABG), but remains controversial. Our study compares the outcomes of consecutive patients undergoing off-pump CABG (OPCABG) with a group of similar patients undergoing consecutive CCABG. METHODS: A retrospective analysis of 268 patients who underwent elective CABG between July 1998 and July 1999 at St. Michael's Medical Center yielded 134 consecutive patients who underwent OPCABG and 134 consecutive patients who had CCABG. Patients' medical charts were reviewed for age, preoperative risk factors, operative findings, postoperative complications, and length of stay (LOS). RESULTS: The two cohorts were well matched, with similar ages (66.4 +/- 11.2 for OPCABG vs. 65.8 +/- 10 for CCABG, p = 0.66) and preoperative ejection fractions (EF) (44 +/- 13 vs. 44 +/- 12, p = 0.85). There were no hospital mortalities, and there were five conversions to cardiopulmonary bypass. The OPCABG group had a significantly shorter ICU and postoperative LOS. CONCLUSIONS: Our data suggests that a fair number of patients are potential candidates for OPCABG, the only contraindications being technical limitations or the surgeon's comfort level. Six- to twelve-month follow-up indicates that OPCABG can be performed safely with a decrease in LOS, and should be part of the surgeon's armamentarium.
Aged↗
Less invasive surgical management of heart failure by cardiac support device implantation on the beating heart.
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Adult↗
Chronic unloading by left ventricular assist device reverses contractile dysfunction and alters gene expression in end-stage heart failure.
BACKGROUND: Left ventricular (LV) assist devices (LVADs) can improve contractile strength and normalize characteristics of the Ca(2+) transient in myocytes isolated from failing human hearts. The purpose of the present study was to determine whether LVAD support also improves contractile strength at different frequencies of contraction (the force-frequency relationship [FFR]) of intact myocardium and alters the expression of genes encoding for proteins involved in Ca(2+) handling. METHODS AND RESULTS: The isometric FFRs of LV trabeculae isolated from 15 patients with end-stage heart failure were compared with those of 7 LVAD-supported patients and demonstrated improved contractile force at 1-Hz stimulation, with reversal of a negative FFR after LVAD implantation. In 20 failing hearts, Northern blot analysis for sarcoplasmic endoreticular Ca(2+)-ATPase subtype 2a (SERCA2a), the ryanodine receptor, and the sarcolemmal Na(+)-Ca(2+) exchanger was performed on LV tissue obtained before and after LVAD implantation. These paired data demonstrated an upregulation of all 3 genes after LVAD support. In tissue obtained from subsets of these patients, Western blot analysis was performed, and oxalate-supported Ca(2+) uptake by isolated sarcoplasmic reticular membranes was determined. Despite higher mRNA for all genes after LVAD support, only SERCA2a protein was increased. Functional significance of increased SERCA2a was confirmed by augmented Ca(2+) uptake by sarcoplasmic reticular membranes isolated from LVAD-supported hearts. CONCLUSIONS: LVAD support can improve contractile strength of intact myocardium and reverse the negative FFR associated with end-stage heart failure. The expression of genes encoding for proteins involved in Ca(2+) cycling is upregulated (reverse molecular remodeling), but only the protein content of SERCA2a is increased.
Adult↗
Left ventricular assist device implantation augments nitric oxide dependent control of mitochondrial respiration in failing human hearts.
OBJECTIVES: The objective of the study was to evaluate nitric oxide (NO) mediated regulation of mitochondrial respiration after implantation of a mechanical assist device in end-stage heart failure. BACKGROUND: Ventricular unloading using a left ventricular assist device (LVAD) can improve mitochondrial function in end-stage heart failure. Nitric oxide modulates the activity of the mitochondrial electron transport chain to regulate myocardial oxygen consumption (MVO2). METHODS: Myocardial oxygen consumption was measured polarographically using a Clark-type oxygen electrode in isolated left ventricular myocardium from 26 explanted failing human hearts obtained at the time of heart transplantation. RESULTS: The rate of decrease in oxygen concentration was expressed as a percentage of baseline. Results of the highest dose of drug are shown. Decrease in MVO2 was greater in LVAD hearts (n = 8) compared with heart failure controls (n = 18) in response to the following drugs: bradykinin (-34+/-3% vs. -24+/-5%), enalaprilat (-37+/-5% vs. -23+/-5%) and amlodipine (-43+/-13% vs. -16+/-5%; p<0.05 from controls). The decrease in MVO2 in LVAD hearts was not significantly different from controls in response to diltiazem (-22+/-5% in both groups) and exogenous NO donor, nitroglycerin (-33+/-7% vs. -30+/-3%). N(w)-nitro-L-arginine methyl ester, inhibitor of NO synthase, attenuated the response to bradykinin, enalaprilat and amlodipine. Reductions in MVO2 in response to diltiazem and nitroglycerin were not altered by inhibiting NO. CONCLUSIONS: Chronic LVAD support potentiates endogenous NO-mediated regulation of mitochondrial respiration. Use of medical or surgical interventions that augment NO bioavailability may promote myocardial recovery in end-stage heart failure.
Adolescent↗
Infections during left ventricular assist device support do not affect posttransplant outcomes.
BACKGROUND: Although infections acquired during ventricular assist device support may increase the risk of infection and have an impact on transplant survival, their true posttransplant consequences remain to be determined. This study evaluates the impact of an outpatient program, newer devices, and an updated infection management protocol on infection-related patient outcomes after transplant. METHODS AND RESULTS: Eighty-six patients received a left ventricular assist device (LVAD) between June 1996 and June 1999. Fifty patients transplanted during the same period, without prior device support, were used as controls; they were matched to transplanted LVAD recipients by age, sex, diagnosis, and transplant date. The nature of and actuarial freedom from peritransplant and posttransplant infections were compared at 6 months after transplant; actuarial patient survival was compared at 3 years. Infection was defined as leukocytosis or leukopenia, with a positive culture requiring either medical or surgical intervention. Forty-four patients (51%) were successfully discharged home on LVAD support, and 61 (71%) were transplanted. A high incidence of infection during device support did not have an impact on pretransplant or posttransplant mortality, posttransplant infectious rate, or overall patient survival. Active infections at transplant also did not significantly influence 6-month mortality. In comparison, LVAD recipients had a lower freedom from infection than did controls (P:<0.05); however, 3-year survival did not differ: 79% and 87% for the LVAD and control groups, respectively. CONCLUSIONS: Although LVADs increase the risk of infection in the early posttransplant period, this appears not to have an impact on transplantability or patient survival and likely reflects effective infection control in both inpatient and outpatient settings.
Adolescent↗
Pilot study of guided imagery use in patients with severe heart failure.
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Exercise Test↗
cAMP pulse during preservation inhibits the late development of cardiac isograft and allograft vasculopathy.
The causes of transplant-associated coronary artery disease remain obscure, and there is no known treatment. Preservation injury of murine heterotopic vascularized cardiac isografts caused a small, albeit significant, increase in neointimal formation; preservation injury of allografts markedly increased both the incidence and severity of transplant-associated coronary artery disease. As cAMP is an important vascular homeostatic mediator the levels of which decline during organ preservation, buttressing cAMP levels solely during initial preservation both improved acute allograft function and reduced the severity of transplant-associated coronary artery disease in grafts examined 2 months later. Inhibiting the cAMP-dependent protein kinase abrogated these beneficial effects. cAMP treatment was associated with an early reduction in leukocyte infiltration and a reciprocal decrease in superoxide and increase in NO levels. These data indicate that alloantigen-independent injury to the graft, which occurs at the time of cardiac preservation, can set in motion pathological vascular events that are manifest months later. Furthermore, a cAMP pulse during cardiac preservation reduces the incidence and severity of transplant-associated coronary artery disease.
Animals↗
Vasopressin in the treatment of milrinone-induced hypotension in severe heart failure.
The use of phosphodiesterase inhibitors such as milrinone in the treatment of severe heart failure is frequently restricted because they cause vasodilation and hypotension. In patients with decompensated heart failure with hypotension after treatment with milrinone, low doses of vasopressin restored blood pressure without inhibiting the inotropic effect of milrinone.
3',5'-Cyclic-AMP Phosphodiesterases↗