What is a ramp study in cardiac implants?
A ramp study with a standardized protocol, as described by Uriel et al. (4), was performed as a routine study in new implants once medical therapy was optimized. Ramp studies were also performed for evaluation of patients who had clinically suspected device thrombosis or recurrent heart failure.
What is the rampart study?
What is the RAMPART study? RAMPART is a randomised controlled trial aimed at kidney cancer patients, whose cancer has been removed by surgery and has not spread to other parts of the body.
Do hemodynamic and echocardiographic ramp tests improve patient outcomes?
Conclusions: Use of combined hemodynamic and echocardiographic ramp tests in patients provides objective means of optimizing RPM, and has the potential to guide medical management. It remains to be tested whether this strategy has a beneficial impact on quality of life or clinical outcomes.
Is the ramp test useful for the detection of LVAD device obstruction?
The ramp test is useful for detection of CF-LVAD device obstruction. However, in the presence of abnormal loading conditions, such as that in patients with AI or hypertension, increasing pump speed may not lead to effective decompression of the left ventricle, and the LVEDD slope may be abnormal, even in the absence of device obstruction.
What is a ramp echo?
The testing uses echocardiography ("echo", ultrasound images of the heart) to create heart images and make measurements while gradually increasing the Left Ventricular Assist Device (LVAD) heart pump speed. Each time the pump speed is increased, images and measurements are taken. This is called a ramp test.
What is a HeartMate 3?
The HeartMate 3 LVAD is a novel centrifugal pump which was developed to provide hemodynamic support in heart failure patients, either as a bridge to transplant (BTT), myocardial recovery, or as destination therapy (DT).
What is LVAD in cardiology?
Left ventricular assist device (LVAD) A ventricular assist device (VAD) — also known as a mechanical circulatory support device — is a device that helps pump blood from the lower chambers of your heart (ventricles) to the rest of your body.
What is the leading cause of death for LVAD patients?
Of 89 patients who died with a DT-LVAD, the median (25th–75th percentile) time from left ventricular assist device implantation to death was 14 (4–31) months. The most common causes of death were multiorgan failure (26%), hemorrhagic stroke (24%), and progressive heart failure (21%).
What is the average life expectancy for someone with an LVAD?
A patient may stay alive for 5 and a half years with LVAD. As per research, 80–85% of patients are alive a year after having an LVAD placed and 70–75% of patients are alive for 2 years with an LVAD. Usually, patients without LVAD have a life expectancy of 12 months or less.
What is the longest someone has lived with an LVAD?
At age 84, Gayle, holds the honor of living on a left ventricular assist device (LVAD) for 10 years. Those odds don't always work that kind of wonder for many – only a few patients in the U.S. have achieved that milestone.
Is an LVAD major surgery?
Implanting an LVAD requires major surgery and the need to stay in the hospital for about two weeks. Some risks of the procedure include bleeding, blood clots, stroke, and infection.
Does heart still beat with LVAD?
An impeller within the pump spins thousands of times a minute, resulting in continuous blood flow, which means LVAD patients don't have a pulse or measurable blood pressure. The external components include a controller—the brains of the system—and batteries, which power the system.
How long can a person live with a LVAD HeartMate 3?
Patients with the HeartMate 3 LVAD had a survival rate of 82.8 percent at two years compared to 76.2 percent for those with the HeartMate II LVAD.
What is the difference between HeartMate 2 and 3?
The HeartMate 3 device is a pulsatile-flow system without mechanical bearings, as opposed to the HeartMate II device which is a continuous-flow system with mechanical bearings which has carried the burden of hemocompatibility related complications, including pump thrombosis, stroke, and gastrointestinal bleeding.
How much does a HeartMate 3 cost?
Hospitals pay a range of prices around $80,000 for a HeartWare device, while the HeartMate 3 runs closer to $95,000, according to research by med-tech market analyst Fernando Amador of Decision Resources Group (DRG), which has North American headquarters in Massachusetts.
What does HeartMate 3 weigh?
HeartMate III heart pump design and features The pump weighs 200gm, measuring 50.3mm in diameter and 55.8mm in height, including inflow cannula, connecting the pump to the patient's circulatory system. It operates at speeds of 3,000rpm and 9,000rpm.
What is the most complicated step in RAMP?
Assessing risk is possibly the most complicated step of RAMP because both objective and subjective components must be considered. Risk determination should be informed by unbiased accurate information. To obtain additional data about chemical and physical hazards, seek information from reliable sources such as experienced researchers and/or safety experts. Use authoritative literature and curated websites such as PubChem and CAMEO Chemicals.
What is the purpose of assessing risks relative to a specific experiment?
Assessing risks relative to a specific experiment informs appropriate strategies for the next step – minimizing risk.
What is the GHS pictogram?
Information from the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) found on labels and Safety Data Sheets (SDSs) is a starting point when researching the hazards of chemicals. The GHS pictogram and hazard codes on a container label convey the overall seriousness of the chemical’s hazards immediately. The manufacturer’s SDS for the chemical provides additional hazard recognition information such as signs and symptoms of exposure, reactivity and stability, and toxicity. For detailed information on the GHS, refer to OSHA’s Hazard Communication Standard.
Which is more effective, control methods at the top or bottom?
The idea behind this hierarchy is that the control methods at the top are generally more effective and protective than those at the bottom.
What are experimental hazards?
In laboratories, experimental hazards can result from a variety of agents, conditions, and/or activities. The fact that a chemical may have an inherent hazard does not mean that it cannot be used in the laboratory as long as the hazard is recognized! Laboratory hazards and risks can be managed using RAMP – Recognize hazards, Assess risk, Minimize risk, and Prepare for Emergencies.
What is RAMPART study?
What is the RAMPART study? RAMPART is a randomised controlled trial aimed at kidney cancer patients, whose cancer has been removed by surgery and has not spread to other parts of the body.
What are the groups in RAMPART?
These are known as Groups A, B and C and are shown in the diagram below. Everyone who takes part will be in one of these groups.
How does Durvalumab work?
It works by helping your own immune system to attack the cancer. Durvalumab is currently being tested by itself or in combination with other treatments in many types of cancer. Early studies have shown that durvalumab works well and has side effects that can usually be well controlled.
What is the treatment for cancer called?
Tremelimumab is another immunotherapy treatment for cancer. It may sometimes be called an ‘anti-CTLA4 drug’ or ‘immune checkpoint inhibitor’. It also works by helping your immune system to attack the cancer.
What is randomization in clinical trials?
As described in the About Clinical Trials page, a process called randomisation is used to allocate people to each group. We use a computer program to do this. Doctors will not have any say in which group their patients are allocated.
Why is it important that the patients in each group are as similar as possible at the start of the study?
Because we do not know if the new treatments will be better than the current standard of care ( no treatment), it is important that the patients in each group are as similar as possible at the start of the study.
Is nivolumab effective for cancer?
A similar drug, nivolumab, has been shown to be effective in treating a number of different types of cancer (lung cancer, a type of skin cancer called melanoma and kidney cancer that has spread outside the kidneys).
Abstract
Ramp studies—measuring changes in cardiac parameters as a function of serial pump speed changes (revolutions per minute [rpm])—are increasingly used to evaluate function and malfunction of continuous-flow left ventricular assist devices (CF-LVADs).
Materials and Methods
In this single-center study, 44 CF-LVAD patients, all HeartMate II (Thoratec Corporation, Pleasanton, CA), were studied. Between 2006 and 2009, the patients underwent 80 ramp tests (1.8 ± 1.0 per patient) measuring hemodynamic changes by right heart catheterization (RHC) as a function of pump speed (revolutions per minute [rpm]).
Results
Patient characteristics are shown in Table 1. The cohort predominantly consisted of male patients suffering from nonischemic cardiomyopathy. In 80% of the cases, the CF-LVAD was utilized as bridge to transplantation (BTT). At the day of ramp testing, support duration was 73 ± 72 days.
Discussion
Data from the clinical trials have documented that CF-LVAD implantation enhances exercise tolerance and QOL in HF patients. 8, 9 The relation between functional capacity and central hemodynamic status, however, has not been well described in HF patients treated with mechanical circulatory support.
Conclusions
Hemodynamic responses during ramp testing in CF-LVAD recipients are associated with measures of functional capacity and QOL. We found that patients in NYHA class I–II had a significantly larger increase in CO/ΔRPM and decrease in PCWP/ΔRPM compared with NYHA III–IV patients. Furthermore, increase in CO/ΔRPM was associated with QOL.
What is ramp test?
Currently, ramp tests are used clinically to rule out device obstruction when the LVEDD slope is <–0.16. However, ramp tests are not perfectly predictive of device thrombosis, and we sought to investigate the conditions under which the test may not perform well. One complication of CF-LVADs that can affect ramp test outcome is the development of de novo continuous aortic insufficiency (AI), which imposes an increase in both pre-load and afterload throughout the cardiac cycle (6). As described in previous case reports, this potentially leads to an inability to decompress the left ventricle, with ensuing recurrent heart failure or hemolysis, which results in a scenario mimicking device thrombosis 7, 8. Furthermore, because the flow generated by CF-LVADs varies with the pressure differential across the pump, output depends on both pre-load and afterload; thus, blood pressure control is essential 9, 10.
Why is ramp test important?
The ramp test is useful for detection of CF-LVAD device obstruction. However, in the presence of abnormal loading conditions, such as that in patients with AI or hypertension, increasing pump speed may not lead to effective decompression of the left ventricle, and the LVEDD slope may be abnormal, even in the absence of device obstruction. Longitudinal studies are required to investigate whether abnormal ramp test results in such patients predict negative outcomes.
How many ramp tests were performed?
Of the 78 ramp tests, 15 (19.2%) were performed for evaluation of heart failure and device optimization, 34 (43.6%) were done for evaluation of possible device thrombosis, and 29 (37.2%) were routine tests performed once medical therapy was optimized. Ramp test results are reported in Table 2 according to thrombosis status. The LVEDD slope was significantly less steep when thrombosis was present (p = 0.008). Furthermore, LDH concentrations were significantly higher in the confirmed thrombosis group than in the non-thrombosis group when measured at the time of referral for ramp testing (p < 0.001).
How long are you followed after a ramp test?
All patients with suspected hemolysis had their devices inspected at these time points. Patients were followed for a minimum of 3 months post-ramp test, and no patients were lost to follow-up.
Why is echocardiography important?
Echocardiography plays an important role in the evaluation of such patients. Ramp studies, in which left ventricular end-diastolic diameter (LVEDD) is recorded using echocardiography at increasing LVAD speeds, can be used not only to optimize device speed, but also to evaluate potential device obstruction 4, 5.
How many false positive ramp tests were performed?
Of the 18 false positive ramp tests, 10 tests were performed in 7 patients who were found to have significant AI; 6 tests were in 6 patients who started with a MAP ≥85 mm Hg that remained consistently >85 mm Hg throughout the study; 1 test was in a patient with high cardiac output heart failure in the setting of bacteremia; and, for 1 test, no cause for the abnormal result could be identified. There was no significant difference in mean LVEDD slope between the false positive tests (−0.10 ± 0.06) and the true positive tests (−0.09 ± 0.50; p = 0.45). No significant differences in power, PI, and MAP at baseline were observed. However, mean LDH was significantly lower in false positive ramp tests (954 ± 609 U/l) than in true positive tests (3,379 ± 1,559 U/l; p < 0.001) ( Figure 1 ).
Is ramp study accurate?
The standardized ramp study protocol described by Uriel et al. (4) was accurate for the detection of pump thrombosis when used in combination with LDH levels in 17 patients with suspected device obstruction. All 8 patients whose devices were explanted after an abnormal ramp study (LVEDD slope ≥−0.16) had either a thrombus in the pump or disconnection of the outflow graft bend relief that was responsible for stabilizing the proximal outflow graft. In that study, the mean MAP was 85.3 ± 9.7 mm Hg; the presence of AI was not reported (4).
Study Questions
Can echocardiography be used to help optimize speed or detect thrombosis in patients supported with continuous flow left ventricular assist devices (LVADs)?
Methods
This was a single-center study of patients supported with HeartMate II LVADs who underwent echocardiography with a standardized ramp protocol.
Results
Thirty-nine patients underwent 52 ramp studies. Of these studies, 28 were performed in 22 patients for speed optimization (54% of studies) and 24 (46% of studies) were done in 17 patients to assess for LVAD thrombosis. In the speed optimization group, 17 (61%) tests resulted in device speed changes of a mean absolute value of 424 ± 211 rpm.
Conclusions
The authors concluded that echo ramp testing can be used for LVAD speed optimization and for detection of device malfunction.
Perspective
The LVAD community certainly benefits from studies aimed at detecting device complications and improving device performance.
