| 1. |
- Karason, Kristjan, 1962, et al.
(författare)
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Randomized trial of a left ventricular assist device as destination therapy versus guideline-directed medical therapy in patients with advanced heart failure. Rationale and design of the SWEdish evaluation of left Ventricular Assist Device (SweVAD) trial
- 2020
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Ingår i: European Journal of Heart Failure. - : Wiley. - 1388-9842 .- 1879-0844. ; 22:2, s. 739-50
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Tidskriftsartikel (refereegranskat)abstract
- Aims Patients with advanced heart failure (AdHF) who are ineligible for heart transplantation (HTx) can become candidates for treatment with a left ventricular assist device (LVAD) in some countries, but not others. This reflects the lack of a systematic analysis of the usefulness of LVAD systems in this context, and of their benefits, limitations and cost-effectiveness. The SWEdish evaluation of left Ventricular Assist Device (SweVAD) study is a Phase IV, prospective, 1:1 randomized, non-blinded, multicentre trial that will examine the impact of assignment to mechanical circulatory support with guideline-directed LVAD destination therapy (GD-LVAD-DT) using the HeartMate 3 (HM3) continuous flow pump vs. guideline-directed medical therapy (GDMT) on survival in a population of AdHF patients ineligible for HTx. Methods A total of 80 patients will be recruited to SweVAD at the seven university hospitals in Sweden. The study population will comprise patients with AdHF (New York Heart Association class IIIB-IV, INTERMACS profile 2-6) who display signs of poor prognosis despite GDMT and who are not considered eligible for HTx. Participants will be followed for 2 years or until death occurs. Other endpoints will be determined by blinded adjudication. Patients who remain on study-assigned interventions beyond 2 years will be asked to continue follow-up for outcomes and adverse events for up to 5 years. Conclusion The SweVAD study will compare survival, medium-term benefits, costs and potential hazards between GD-LVAD-DT and GDMT and will provide a valuable reference point to guide destination therapy strategies for patients with AdHF ineligible for HTx.
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| 2. |
- Sundbom, Per, 1981-
(författare)
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Acoustic and afterload evaluation of left ventricular assist devices
- 2019
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Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
- Background: Heart Failure is a serious condition with consequences not only for the individual patient but also for the society with a 5-year mortality rate of 45-60%, and a substantial economic burden. The estimated prevalence in Sweden is 2.2% and the age adjusted prevalence increases with higher age. The fundamental treatment for heart failure is pharmaceutical in combination with life-style changes, and physiotherapy. For patients with advanced heart failure, the use of long-term circulatory support can be an option as a bridge to transplantation, or as destination therapy. However, this treatment entails a risk of multiple adverse events. The incidence of pump thrombosis increased as a clinical problem in 2012 and the need for diagnostic methods were desired. The aim of this thesis was to develop and to evaluate the use of a mock loop circuit to study the acoustics of left ventricular assist devices, to evaluate different recording devices and to study the effect of afterload on pump function.Methods: Two different mock loops, with the possibility to insert artificial thrombus and to adjust preload and afterload were created to facilitate recording of the left ventricular assist devices. An iPhone/iPodTM was used as recording device since remote monitoring is desirable. The sounds from HeartMate IITM during different conditions were studied. The iPhone/iPod was evaluated in comparison to dedicated recording equipment, and the mock loop recordings to clinical situation. The sound from HeartMate 3TM was studied, compared between in vivo and in vitro recordings, and the use of an electronic stethoscope was evaluated. The impact of afterload on left ventricular assist devices was studied in a mock loop circuit with different changes in preload and afterload.Results: Mock loop circuit is a promising method to safely change the surrounding conditions as the pump is working. The sound from both HeartMate IITM and HeartMate 3TM can be recorded and analyzed in frequency and time domain. When inserting artificial thrombus in a HeartMate IITM the frequency spectrum is altered. The use of dedicated recording devices is superior to both electronic stethoscope and iPhone/iPodTM, but these handheld devices can be used in clinical settings. The recordings from mock loop circuit and patients appear similar for both HeartMate IITM and HeartMate 3TM. The flow of the devices is affected by the afterload. The HeartMate 3TM is more resistant to increased clot analogs within the pump. For both pumps, best efficacy is seen for clean circuits. The flow rate from the monitor might be misleading since the measured flow rate and the flow rate from monitor can differ due to surrounding conditions. The estimated flow might be adjusted by fitting a parabolic curve.Conclusion: The use of mock loop circuit to study both flow and sound under different conditions is valid. It is possible to record and study the sound from both HeartMate IITM and HeartMate 3TM. The sound holds information of pump function and appears similar in vivo and in vitro. All recording devices can be used, but dedicated equipment is superior to the more handheld devices, although these might have a function as a screening device. The flow measurement on the monitor might not be valid and optimization of fluid status and afterload can further increase pump efficiency.
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| 3. |
- Sundbom, Per, 1981-, et al.
(författare)
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Sound analysis of the magnetically levitated left ventricular assist device HeartMate 3™
- 2019
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Ingår i: International Journal of Artificial Organs. - : Sagamore Publishing. - 0391-3988 .- 1724-6040. ; 42:12, s. 717-724
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Tidskriftsartikel (refereegranskat)abstract
- INTRODUCTION: The HeartMate 3™ has shown lower rates of adverse events compared to previous devices due to the design and absence of mechanical bearings. For previous devices, sound analysis emerged as a way to assess pump function. The aims of this study were to determine if sound analysis can be applied to the HeartMate 3 in vivo and in vitro and to evaluate an electronic stethoscope.METHOD: Sound recordings were performed with microphones and clinical accessible electronic stethoscope. The recordings were studied in both the time and the frequency domains. Recordings from four patients were performed to determine if in vivo and in vitro recordings are comparable.RESULTS: The results show that it is possible to detect sound from HeartMate 3 and the sound spectrum is clear. Pump frequency and frequency of the pulsatile mode are easily determined. Frequency spectra from in vitro and in vivo recordings have the same pattern, and the major proportion (96.7%) of signal power is located at the pump speed frequency ±40 Hz. The recordings from the patients show low inter-individual differences except from location of peaks originating from pump speed and harmonics. Electronic stethoscopes could be used for sound recordings, but the dedicated equipment showed a clearer sound spectrum.DISCUSSION: The results show that acoustic analysis can also be performed with the HeartMate 3 and that in vivo and in vitro sound spectrum is similar. The frequency spectra are different from previous devices, and methods for assessing pump function or thrombosis need further evaluation.
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| 4. |
- Broström, Anders, 1963-, et al.
(författare)
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Effects of Long-term Nocturnal Oxygen Treatment in Patients With Severe Heart Failure
- 2005
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Ingår i: Journal of Cardiovascular Nursing. - Philadelphia : Lippincott Williams & Wilkins. - 0889-4655 .- 1550-5049. ; 20:6, s. 385-395
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Tidskriftsartikel (refereegranskat)abstract
- Sleep-disordered breathing (SDB) is common in patients with heart failure (HF) and leads to disturbed sleep. The objective of this study was to determine the persistent effects of long-term nocturnal oxygen treatment in patients with severe HF regarding (1) objective outcomes, such as steep. SDB, cardiac function, and functional capacity; (2) subjective outcomes, such as self-assessed sleep difficulties, daytime sleepiness, and health-related quality of life (HRQOL); and (3) the relationship between objective and subjective outcomes. In this open nonrandomized experimental study, 22 patients, median age 71 years, with severe HF were studied before and after 3 months of receiving nocturnal oxygen. The measures used were overnight polysomnography, echocardiography, 6-minute walk test, self-assessed sleep difficulties (Uppsala Sleep Inventory-HF), daytime sleepiness (Epworth Sleepiness Scale), and HRQOL (36-ltem Short Form Health Survey and Minnesota Living with Heart Failure Questionnaire). SDB, with a 90% dominance of central sleep apnea, occurred in 41 % of the patients with severe HF before intervention. After intervention, functional capacity improved for both the whole group of patients with HF (P < .01) and HF patients with SDB (P < .05). No improvements regarding cardiac function, objective sleep, subjective sleep, or SDB were seen, except for a decrease of ‚â•4% desaturations (P < 05). HRQOL did not differ significantly between HF patients with and without SDB before or after intervention with nocturnal oxygen. Long-term nocturnal oxygen treatment improved functional capacity in patients with severe HF, with or without SDB. No improvements were seen regarding sleep, daytime sleepiness, SDB, cardiac function, or HRQOL.
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| 5. |
- Hedayati, E., et al.
(författare)
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Outcome and presentation of heart failure in breast cancer patients : Findings from a Swedish register-based study
- 2020
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Ingår i: European Heart Journal - Quality of Care and Clinical Outcomes. - : Oxford University Press. - 2058-5225 .- 2058-1742. ; 6:2, s. 147-155
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Tidskriftsartikel (refereegranskat)abstract
- Aims: Heart failure (HF) patients diagnosed with breast cancer (BC) may have a higher risk of death, and different HF presentation and treatment than patients without BC.Methods and results: A total of 14 998 women with incident HF (iHF) or prevalent HF (pHF) enrolled in the Swedish HF Registry within and after 1 month since HF diagnosis, respectively, between 2008 and 2013. Patients were linked with the National Patient-, Cancer-, and Cause-of-Death Registry. Two hundred and ninety-four iHF and 338 pHF patients with BC were age-matched to 1470 iHF and 1690 pHF patients without BC. Comorbidity and treatment characteristics were compared using the χ2 tests for categories. Cox proportional hazard models assessed the hazard ratio (HR) and 95% confidence intervals (95% CIs) of all-cause and cardiovascular mortality among HF patients with and without BC. In the pHF group, BC patients had less often myocardial infarction (21.6% vs. 28.6%, P < 0.01) and received less often aspirin (47.6% vs. 55.1%, P = 0.01), coronary revascularization (11.8% vs. 16.2%, P < 0.01), or device therapy (0.9% vs. 3.0%, P = 0.03). After median follow-up of 2 years, risk of all-cause mortality (iHF: HR = 1.04, 95% CI = 0.83-1.29 and pHF: HR = 0.94, 95% CI = 0.79-1.12), cardiovascular mortality (iHF: HR = 0.94, 95% CI = 0.71-1.24 and pHF: HR = 0.89, 95% CI = 0.71-1.10), and HF mortality (iHF: HR = 0.80, 95% CI = 0.34-1.90 and pHF: HR = 0.75, 95% CI = 0.43-1.29) were similar for patients with and without BC in the iHF and pHF groups.Conclusion: Risk of all-cause and cardiovascular mortality in HF patients did not differ by BC status. Differences in pre-existing myocardial infarction and HF treatment among pHF patients with and without BC may suggest differences in pathogenesis of HF.
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| 8. |
- Sundbom, Per, 1981-, et al.
(författare)
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Progressive multifocal leukoencephalopathy after heart transplantation: 4 years of clinically stable infection on low-dose immunosuppressive therapy
- 2017
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Ingår i: Oxford Medical Case Reports. - : Oxford Academic. - 2053-8855. ; 2017:2, s. 15-17
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Tidskriftsartikel (refereegranskat)abstract
- Progressive multifocal leukoencephalopathy (PML), caused by reactivation of JC-virus is a relatively rare complication seen in patients with compromised immune system. There are no evidence-based treatment available and prognosis is poor. Withdrawal of immunosuppressant can result in further neurological deterioration and for patients with solid organ transplantations, fatal graft rejection. We report a 52-year-old women that presented with seizures within 1 month after heart transplantation. Initial diagnosis was vascular disease. After clinical deterioration 10 months after transplantation, further examinations led to the diagnosis. Minimizing tacrolimus, to a concentration of 2 ng/ml, and extensive physical therapy has improved the physical capacity of the patient. The patient has now been clinically stable for 4 years and extended survival for 5 years. This case adds to the limited adult cases of PML within the population of heart transplant recipients and the need for increased awareness to minimize diagnosis delay.
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