Safe, reliable, accurate and affordable respiratory control technology to protect patients during imaging and radiotherapy
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Introduction – Breath Hold
The Breath Hold ES, developed by Medspira and physicians at a leading US hospital, uses a biofeedback and display technique that enables patients to self-monitor their breath-holds or to control breaths during periods of shallow breathing (1,2). Pentland Medical are marketing this device in the UK as Breath Hold (3).
Breath Hold is used by patients undergoing procedures where breath control is required or is beneficial. These diagnostic and therapeutic procedures include:
- Imaging – of the breast, chest wall, lungs and upper abdomen.
- Image-guided biopsy – of the breast, chest wall, lungs and upper abdomen.
- Image-guided radiotherapy (IGRT) – of the breast, chest wall, lungs and upper abdomen.
- Radiotherapy – of the breast.
In radiation therapy planning and within the context of image-guided radiotherapy (IGRT), it is important to have images of the highest possible quality. By breath-holding, it is possible to minimise or eliminate breathing artefacts and distortions, resulting in better quality images.
Magnetic resonance imaging (MRI) is becoming more prevalent, replacing computed tomography (CT), because it is safer for the patient, reducing potentially harmful radiation exposure. The use of Breath Hold has the potential to reduce the time needed for imaging a patient, and so reduce the radiation dose even further.
Breath Hold is cost-saving as it reduces the requirement for repeat imaging due to chest wall movement during image capture.
In image-guided diagnostic procedures, such as biopsy and fine needle aspiration (FNA) cytology, the device has the potential to reduce the rate of false-negative or inadequate biopsy diagnoses; both of which can occur when the sampling needle misses the tissue abnormality, due to respiratory movements (4).
Breath Hold and the Patient
Breath Hold works by measuring changes in the patient’s abdominal girth with each respiration. Breath Hold uses an expandable ‘bellows’ system attached to a transducer tube, which wraps around the patient’s chest or stomach to assess respiratory pressure.
In the ‘breath monitoring’ process, a reference point is selected which is typically either an inhale or exhale point. After point selection, the Breath Hold monitor indicates when the patient has their respiratory targets; additional visual alerts let the patient know if they have moved from the desired ‘hold’ position. To support a reproducible shallow respiratory pattern, patients use the visual cues from the Breath Hold monitor to maintain their breathing within a certain range.
The clinical problem of control of respiratory motion will be familiar to healthcare professionals who work in imaging and radiotherapy specialties (4).
In summary, the advantages to the patient and the healthcare practitioner of Breath Hold are:
- Consistent breath-holds or shallow, controlled breathing.
- Reduction of target tissue mobility during diagnostic biopsy procedures.
- Biofeedback allows proactive breathing control for patients.
- Increased patient comfort and ease of use when compared with other respiratory motion control technologies in imaging and radiotherapy.
- Provides respiratory motion control for interventional radiology.
- Portable, stand-alone system.
- Ease of set-up for each patient.
- Affordably priced (5).
Published Evidence to Support the Clinical Benefit of Breath-Holding Devices
1) Radiation damage to the heart in breast cancer patients could be prevented or reduced by targeted radiation therapy assisted by controlled breath-holding
In 2014, an estimated 235,000 new cases of breast cancer were diagnosed and each year approximately 40,000 women worldwide will die from breast cancer (6). Adjuvant radiation therapy, following either breast-conserving surgery or mastectomy is used to reduce the risk of local cancer recurrence.
Radiation therapy to the breast and the chest causes radiation-related morbidity and mortality that may offset some of the benefits of radiation therapy (7). An important consequence of left-sided radiation therapy is damage to the heart (7). The effects of radiation on the heart can result in a spectrum of changes now termed, ‘radiation-induced heart disease’ (RIHD) (7). The chronic effects of cardiac radiation damage include pericarditis, myocardial fibrosis, coronary artery disease, pericardial effusions, valvular disease, and cardiac arrhythmia (7). Radiation damage to small- and medium-sized cardiac blood vessels results in a form of ischaemic heart disease (IHD) (8).
Since 2001, studies have shown that deep inspirational breath holding during tangential breast radiotherapy can reduce the amount of irradiated cardiac tissue (9). In 2011, a CT imaging study quantified the reduction of radiation dose to the heart and lung, using deep inspiration breath-hold (10). This study concluded that cardiac and pulmonary radiation doses were reduced without compromising the target coverage (10).
In 2012, deep inspiration breath holding was shown to significantly reduce the radiation dose to the heart during left breast radiotherapy (11). In 2013, a study including more than 2,000 women was published in the New England Journal of Medicine (12). The study showed that exposure of the heart to ionizing radiation during radiotherapy for breast cancer increased the patient’s subsequent risk of ischaemic heart disease (IHD) (12). This study found that the risk of IHD post-radiotherapy was proportional to the mean radiation dose to the heart (12). The damage was thought to begin within a few years after radiation exposure and to continue for at least a further 20 years (8). This research was partly funded by Cancer Research UK (CRUK) (12).
Following this publication, there was increased recognition of the problem of inadvertent radiation damage to the heart (12,13). Some reports in the media called for recognition of this serious cardiac complication and called for greater measures to limit the development of cardiac radiation damage (13).
In 2013, the results of the UK HeartSpare Study were published (14). HeartSpare was a randomised controlled study to evaluate voluntary deep inspiratory breath-hold in women undergoing breast radiotherapy (14). Two techniques were compared, voluntary deep inspiratory breath-hold and deep inspiratory breath-hold using a breathing coordinator device. Both techniques were comparable in terms of normal tissue sparing, positional reproducibility and feasibility of delivery in this study (14).
In 2014, Bartlett and colleagues published data to support the reduction of the amount of radiation received by the heart during tangential-field radiotherapy using breath-holding techniques (15). In this publication, it was stated that:
‘Despite clear dosimetric benefits, these techniques are not yet in widespread use’ (15).
2) Controlled breath-holding results in increased accuracy in image-guided radiotherapy to the upper abdomen
The organs of the upper abdomen, including the liver, stomach and kidneys, move with the respiratory movements of the chest and diaphragm. The diagnostic and therapeutic problems caused by the respiratory movement has recently been termed the ‘respiratory related target motion and set up error’ (16).
Recent publications have shown that breath-holding techniques allow for greater accuracy in localising radiotherapy to the liver and stomach when used with imaging techniques (16,17). Unless breath-holding is used, there will be a large margin of irradiated normal tissue due to respiratory movement, particularly around highly mobile organs such as the stomach (16).
3) Image-guided biopsy procedures are more accurate and take less time when assisted by controlled breath-holding
Interventional radiologists at the University of California, San Diego, have used Breath Hold to improve targeted biopsy accuracy for complex image-guided procedures of the lungs and liver (18). Another procedure that is optimised through the use of the biofeedback characteristics of Breath Hold is ‘localisation biopsy,’ which is the insertion of localising needles or hooked wires to mark tumours for surgical excision. Breath Hold has been reported to be invaluable during these types of localisation biopsy procedures, which are affected by respiratory motion (18).
4) Potential cost savings to the NHS with the use of Breath Hold
Breath Hold has a wide range of potential benefits for patients requiring targeted diagnostic or treatment procedures. The cost benefits to the NHS include reduction of procedure times and the greater accuracy of imaging and treatment procedures.
There are long-term cost benefits too (5). The UK has an increasing number of cancer survivors, who now live with the long-term consequences of cancer treatment (19). This population of cancer survivors is likely to increase as early cancer detection rates increase (19). It makes economic sense to reduce the long-term complications of radiation damage to normal tissues, such as the heart (12).
Cost: the Breath Hold system
The Breath Hold system is priced at between £10,000 to £14,000 and with negligible running costs.
In conclusion, in the present climate of NHS cost-savings, combined with increased patient safety concerns, Breath Hold is a device that a modern health service cannot afford to be without.
This report has been received and reviewed by Medspira,
July 2nd 2015, prior to online publication.
If you would like to comment on any of the issues raised by this article, particularly from your own experience or insight, Healthcare-Arena would welcome your views.
(1) Medspira, Minnesota, USA. website. http://medspira.com Accessed June 26th, 2015
(2) Medspira Breath Hold ES. Product Information. http://medspira.com/products/breath-hold/respiratory-motion-control-for-radiation-therapy/ Accessed June 26th, 2015
(3) Pentland Medical. Enhanced breathing precision for procedures targeting the lungs and upper abdomen with Breath Hold. Product Information. http://www.pentlandmedical.co.uk/index.php/products/radiation-therapy-ct/medspira-breath-hold/ Accessed June 26th, 2015
(4) American Association of Physicists in Medicine. Task Group. The Management of Respiratory Motion in Radiation Oncology. AAPM. Published, July 2006. https://www.aapm.org/pubs/reports/RPT_91.pdf Accessed June 26th, 2015
(5) Kaplan RS, Porter ME. How to solve the cost crisis in health care. Harv Bus Rev. 2011;89:47–64. http://www.ncbi.nlm.nih.gov/pubmed/21939127 Accessed June 26th, 2015
(6) Siegel R, Ma J, Zou Z, Jemal A. Cancer statistics, 2014. CA Cancer J Clin (2014) 64(1):9–2910. http://www.ncbi.nlm.nih.gov/pubmed/24399786 Accessed June 26th, 2015
(7) Early Breast Cancer Trialists’ Collaborative Group (EBCTCG). Effect of radiotherapy after breast-conserving surgery on 10-year recurrence and 15-year breast cancer death: meta-analysis of individual patient data for 10 801 women in 17 randomised trials. Lancet. 2011;378(9804):1707-1716. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3254252/ Accessed June 29th, 2015
(8) Taunk NK, Haffty BG, Kostis JB, Goyal S. Radiation-Induced Heart Disease: Pathologic Abnormalities and Putative Mechanisms. Frontiers in Oncology. 2015;5:39-44. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4332338/ Accessed June 29th, 2015
(9) Sixel K, Aznar MC, Ung YC. Deep inspiration breath hold to reduce irradiated heart volume in breast cancer patients. Int J Radiat Oncol Biol Phys 2001;49:199–204. http://www.ncbi.nlm.nih.gov/pubmed/?term=11163515 Accessed June 29th, 2015
(10) Vikstrom J, Hjelstuen MH, Mjaaland I, Dybvik KI. Cardiac and pulmonary dose reduction for tangentially irradiated breast cancer, utilizing deep inspiration breath-hold with audio-visual guidance, without compromising target coverage. Acta Oncol. 2011;50:42–50. http://informahealthcare.com/doi/abs/10.3109/0284186X.2010.512923 Accessed June 29th, 2015
(11) Hayden AJ, Rains M, Tiver K. Deep inspiration breath hold technique reduces heart dose from radiotherapy for left-sided breast cancer. J Med Imaging Radiat Oncol. 2012;56:464–472. http://onlinelibrary.wiley.com/doi/10.1111/j.1754-9485.2012.02405.x/full Accessed June 29th, 2015
(12) Darby SC, Ewertz M, McGale P et al. Risk of Ischemic Heart Disease in Women after Radiotherapy for Breast Cancer. NEJM 2013;368:987-998. http://www.nejm.org/doi/full/10.1056/NEJMoa1209825 Accessed June 26th, 2015
(13) Lambert C. Holding your breath can beat lethal side-effect of breast radiotherapy. Daily Mail. May 19, 2015. http://www.dailymail.co.uk/health/article-3086794/Holding-breath-beat-lethal-effect-breast-radiotherapy.html Accessed June 26th, 2015
(14) Bartlett FR, Colgan RM, Carr K et al. The UK HeartSpare Study: Randomised evaluation of voluntary deep-inspiratory breath-hold in women undergoing breast radiotherapy. Radiother. Oncol. 2013;108:242–247. http://www.ncbi.nlm.nih.gov/pubmed/23726115 Accessed June 29th, 2015
(15) Bartlett FR, Colgan RM, Donovan EM, et al. Voluntary Breath-hold Technique for Reducing Heart Dose in Left Breast Radiotherapy. Journal of Visualized Experiments : JoVE. 2014;(89):51578. doi:10.3791/51578. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4211647/ Accessed June 29th, 2015
(16) Hu W, Ye J, Wang J, Xu Q, Zhang Z. Incorporating breath holding and image guidance in the adjuvant gastric cancer radiotherapy: a dosimetric study. Radiat Oncol. 2012;7:98. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3439279/ Accessed June 29th, 2015
(17) Bloemen-van Gurp E, et al. Active breathing control in combination with ultrasound imaging: a feasibility study of image guidance in stereotactic body radiation therapy of liver lesions. Int. J. Radiat. Oncol. Biol. Phys. 2013;85:1096–1102. http://www.redjournal.org/article/S0360-3016(12)03402-5/fulltext Accessed June 29th, 2015
(18) Case Study: Interventional Radiology. Biofeedback Device Helps Put Respiratory Motion on Hold. Nationally Recognized Interventional Radiologist Calls Breath Hold a ‘Game Changer.’ http://www.memed.at/download/atemtriggerung/casestudy.pdf Accessed June 29th, 2015
(19) Maddams J, Utley M, Moller H. Projections of cancer prevalence in the United Kingdom, 2010-2040. Br. J. Cancer. 2012;107:1195–1202. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3461160/ Accessed June 29th, 2015