VERVE
Research type
Research Study
Full title
Validation of hEart Rate recoVery as a pEri-operative risk measure (VERVE)
IRAS ID
299559
Contact name
Cara Hughes
Contact email
Sponsor organisation
National Waiting Times Centre Board
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Research Summary
The number of operations the NHS performs increases every year, and patients undergoing operations are becoming sicker. The risk of complications after an operation is dependent on the type of surgery, the patient’s underlying health problems and their physical fitness; doctors use this information to provide a risk assessment for the patient. If an operation is very high risk, a patient may undergo cardiopulmonary exercise testing (CPET) where the patient rides an exercise bike to maximum effort (exhaustion) whilst their heart and lung function is measured. CPET however is not widely available and some patients are unable to perform the test. It can also be very demanding and uncomfortable for patients. We believe there is a “middle-ground” exercise test where patients will not need to exercise until exhaustion yet it may still provide enough information to be able to predict the risk of post-operative complications. For this test, the patient wears a portable non-invasive heart rate monitor. The patient will exercise to approximately two-thirds of their predicted maximum heart rate, and then the rate of recovery of their heart rate (HRR) at the end of exercise is measured. The faster the heart rate recovers, the fitter a patient is. We are aiming to recruit 95 patients over the age of 50 years undergoing intermediate or high risk surgery over one year. We will recruit patients undergoing a range of operations from four hospitals in the West of Scotland. The HRR test will be performed pre-operatively. After the operation we will collect information about post-operative complications to see if HRR is a valid predictive test compared to the measures doctors currently use to predict risk, including CPET. If HRR proves to be a valid measure, it will add valuable information to aid shared decision-making between patients and doctors before an operation.Summary of Results
The study took place at three hospitals in the West of Scotland: Golden Jubilee National Hospital, University Hospital Crosshouse and University Hospital Hairmyres.Purpose of the study
* To see if heart complications after planned surgery can be predicted based on how quickly the heart rate falls (heart rate recovery (HRR)) after moderate exercise.
* To see how HRR compares to the tools currently used to predict complications after surgery.People taking part
84 people aged over 50 took part. These individuals had intermediate/high risk operations. Everyone needed to be able to walk unaided to be included in the study.Results
Heart complications after surgery were predicted by how fast heart rate has fallen one minute after stopping moderate exercise. It was also linked to kidney complications after surgery. However, it was not linked to other complications such as lung problems, infection or length of stay in hospital. Compared to the tools currently in use for assessing risk, HRR was as good as or better. Overall, the results indicate that heart rate recovery one minute after moderate exercise could be useful to help guide risk assessment before an operation.Safety
In this study, researchers found that it was safe to perform the step test before the operation.Why did we do this study?
People who are fitter and can exercise for longer recover better after major operations. Heart rate rises during exercise and then falls back to normal afterwards. Heart rate falls back to normal quicker in fitter people compared to unfit people.
Currently, healthcare staff assess patient fitness by asking patients about their usual activity levels or by asking patients to exercise as hard as they can on an exercise bike whilst measuring breathing, heart rate and blood pressure. These methods give healthcare staff and the patient information about their risk of complications for their upcoming operation. However, not all patients are able to do the exercise test fully and there is evidence that just asking patients about activity levels is not always accurate at predicting risk. Therefore, the researchers wanted to see whether how fast the heart rate falls after moderate exercise could be a useful tool to predict risk.What did the study involve?
Patients exercised in pre-assessment clinic or on the ward to moderate exertion by stepping on and off a box before surgery. Two stickers measuring heart rate were placed on their chest and the researchers looked at how fast their heart rate fell (HRR) when exercise stopped. The researchers tested to see whether HRR predicted injury to the heart muscle either during or after the operation. We also compared it to a blood test, other risk scores and the maximal exercise (bike) test to see whether it was as good a measure as what is currently used in the NHS.
Noone had any problems performing the step test.What were the overall results of the study?
The results showed that the fall in heart rate until one minute after the end of the step test (called heart rate recovery after one minute (HRR1)) was predictive for injury to the heart muscle. We looked at lots of other ways of measuring the fall in heart rate including at different time points after exercise. Although a few more of these measures were also predictive for injury to the heart muscle, HRR1 performed best. We also showed that adding HRR1 to the other tools currently used to assess risk improved their performance.
Heart rate recovery after one minute also demonstrated fair prediction for other postoperative complications including kidney injury and admission to intensive care. However, it did not appear predictive for other heart or lung complications, or for hospital length of stay or how well patients recovered from their surgery.
When compared to the risk prediction measures healthcare staff currently use, HRR1, after the step test, was as good as, or better than most. This included a blood test which looks at heart strain before an operation, a questionnaire on pre-operative activity levels, and scores which are calculated using health history and surgical information.
Overall, the study demonstrated that measuring the fall in heart rate after a step test to moderate exertion predicts injury to the heart muscle after an operation. Measuring the difference in heart rate from the end of exercise to one minute after (HRR1) was comparable to different types of risk measure currently used in the NHS. We hope to publish the main results from this trial in a clinical journal soon.How has this study helped patients and researchers?
How fast the heart rate falls after moderate exercise may be a good measure of fitness in patients who are undergoing surgery. It is easy to measure, easy for a lot of patients to perform and gives valuable information which is currently missing in pre-operative assessment. This study allows us to plan further investigations of submaximal HRR to assess its usefulness in a larger population.
Researchers look at the results of many studies to understand which tools are best for predicting complications after surgery. It takes many people and many studies all around the world to advance medical science. This summary only shows the results from this one study. Other studies may find different results. This study was relatively small and in a small area of the UK. If HRR after moderate exercise is to be used to predict complications after surgery, larger, more widespread studies are required. If a larger study has positive results, it could be introduced to standard care in the NHS.Are there plans for further studies?
Yes, the research group is hoping to perform a larger study to see if these positive results can be repeated in more patients. Also to see if HRR after moderate exercise can be measured using equipment already in use in the NHS. This larger study is currently in the planning stage and is not guaranteed to go ahead.Where can I find more information about this study?
To learn more about this study, visit https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fclinicaltrials.gov%252Fstudy%252FNCT05561608%253Fcond%253DNCT05561608%2526rank%253D1.%2FNBTI%2FU4i_AQ%2FAQ%2F8e872e16-4cf5-4ac1-9e2c-9caff8905860%2F2%2F7oCyjEfVf0&data=05%7C02%7CWales.REC4%40wales.nhs.uk%7C5f8ee83401f7462a340308ddbecb8394%7Cbb5628b8e3284082a856433c9edc8fae%7C0%7C0%7C638876504741079206%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=9jSNBxrn4GVkoqbJR%2B9csioO2B5yz2YtYAPdnepHHJ0%3D&reserved=0 More information may also be available by looking up the official title or reference numbers given above.
For more information about preparing for surgery and risk of operations, visit https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fwww.rcoa.ac.uk%252Fpatients%252Fpatient-information-resources%252Fpreparing-for-surgery.%2FNBTI%2FU4i_AQ%2FAQ%2F8e872e16-4cf5-4ac1-9e2c-9caff8905860%2F3%2FWHpczSZCMK&data=05%7C02%7CWales.REC4%40wales.nhs.uk%7C5f8ee83401f7462a340308ddbecb8394%7Cbb5628b8e3284082a856433c9edc8fae%7C0%7C0%7C638876504741089271%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=m8%2FVdy7C6MOBB10MTmnnBNO7%2Bt2i4trprrBALfV%2FLd4%3D&reserved=0
For more information about research studies, go to:
https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fwww.nhs.uk%252Ftests-and-treatments%252Fclinical-trials%252F%2FNBTI%2FU4i_AQ%2FAQ%2F8e872e16-4cf5-4ac1-9e2c-9caff8905860%2F4%2F_F5zWyIdoY&data=05%7C02%7CWales.REC4%40wales.nhs.uk%7C5f8ee83401f7462a340308ddbecb8394%7Cbb5628b8e3284082a856433c9edc8fae%7C0%7C0%7C638876504741098885%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=dIj1jf9Yi4o89VqN4VUKUg1y66kNXf3sB%2BXYfUjU3BI%3D&reserved=0
https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fwww.clinicaltrials.gov%252Fstudy-basics%252Flearn-about-studies%2FNBTI%2FU4i_AQ%2FAQ%2F8e872e16-4cf5-4ac1-9e2c-9caff8905860%2F5%2FVwec3_VjqL&data=05%7C02%7CWales.REC4%40wales.nhs.uk%7C5f8ee83401f7462a340308ddbecb8394%7Cbb5628b8e3284082a856433c9edc8fae%7C0%7C0%7C638876504741108666%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=Ob04PegllPPxSzH5AuxRyRUaYgUteoiZsIgm51rYWyk%3D&reserved=0REC name
Wales REC 4
REC reference
21/WA/0207
Date of REC Opinion
28 Jul 2021
REC opinion
Further Information Favourable Opinion