If we are to revolutionize heart surgery, we have to do it right!

May 2, 2018

This was the motivation to initiate the survey Cardiaccs did with Cetas Healthcare and Shane West of Skuld Insight. The product has clear advantages, but are they the attributes sought for by the cardiac surgeons?

Article from Norway Health Tech member Cardiaccs on their road to targeted clinical trials:

Cardiovascular related diseases are the leading cause of hospitalization and death worldwide, accounting for more than 17 million deaths per year*. Due to an aging population, there is an increase in patients with complex cases where open heart surgeries are required. For these patients, there is an urgent need for better cardiac monitoring to reduce morbidity and mortality. This is the challenge Cardiaccs has taken on.

We develop a new technology that allows continuous monitoring of the heart function, during and after cardiac surgery, called CardiSense. CardiSense is a combined bipolar temporary pace lead and sensor that measures myocardial contractility – a vital parameter for monitoring of the cardiac function. With CardiSense, we will reduce hospital costs, patient morbidity and mortality associated with cardiac surgery through a unique monitoring technology requiring no additional procedures, no changes in staff behaviour and very limited staff training  We are soon ready to go into clinical studies, but we wanted to ensure that we are testing the right way looking for the right things, so we wanted to talk to the people using existing equipment that Cardiaccs is looking to replace, namely the cardiac surgeons. We concentrated on two major markets; the US and Germany.

Standard monitoring used today

Today there are many approaches to monitor the heart intra-and post-surgery such as ECG, invasive pressure catheters, and echocardiographic imaging. For detailed and continuous heart function monitoring, a pulmonary artery catheter, also known as a Swan Ganz, can be used both intra-and post-surgery, but this is associated with a high risk of complications. One of the findings in the survey is that there is a difference in the use of these catheters between the markets, as it is used in approximately 90-95 % of the patients in the US, while rarely used in Germany (approx. 5%). The feedback from the surgeons that use Swan Ganz is that they are quite happy with it, but it has a high risk of bleeding due to high invasiveness. It is also time demanding to install and administer, as well as having high investment and maintenance costs.

“One of the disadvantages is that a catheter needs to be placed in the pulmonary vein. In the lung flow area with a balloon which bears the risk for arrhythmia, lung embolisms and infections. Therefore, in my opinion the disadvantages outweigh the benefit in most cases and therefore it has become so rare.” (German respondent)

The challenge and unmet medical need

We asked the surgeons what pain points they are experiencing today. They divided this into two categories; monitoring and drug administration. With the monitoring, the challenges with Swan Ganz were high bleeding risk and it being very invasive. It also challenges the staff to be highly experienced as it is complicated to administer. Other issues were thick cables and post-op complications in arterial lines.

With drug administration the main difficulty was that it required high experience to do it right.

“If there would be the possibility to say that as of these measured values the drug dosage will be modified, it would be an interesting approach.” (German respondent)

We asked what they would consider being the features of an ideal monitoring technology, and the three most important ones were less- or-non-invasive monitoring, wireless data transfer and analysing software.

Perception of the concept

So, with the today situation mapped, we asked the respondents to look at our concept. Driven by the prospect of a lower complication rate due to early detection, there was a high willingness in both markets to try CardiSense.

The drivers for usage were early detection of complications, measurement of contractility, lower complication rate and as provider of critical information.

There were also barriers; anticipated high costs, lack of clinical data, bleeding risk and all physicians at the department must agree – however, the barriers were perceived lower than the drivers. Their feedback on the potential use of CardiSense were to replace Swan Ganz, echocardiography or epicardial pacemaker.

The large majority of respondents found the CardiSense concept interesting and understood the measurement of the cardiac contractility. The responses were mainly positive: direct measurement of cardiac muscle mobility and a very good/interesting concept.

The main perceived advantage was the visibility of the contractility of the myocardium and therefore early detection of myocardial ischemia.

“It is an additional information that could reveal problems or complications faster than other parameters which have to be detected after a problem is suspected, e.g. a TEE (TransEsophageal Echocardiography , ultrasound through the throat) is performed. I could imagine that a problem could be signaled at an earlier stage.” (Resp.5)

The respondents found the approach of data generation by using pacemaker electrodes highly interesting.

Some conclusions

The concept of CardiSense was received positively by both groups of respondents but gave some clear issues to address. To address the potential barriers, crucial data which would remove remaining concerns were asked for. Most of this is implemented in Cardiaccs study outline for the upcoming trial.

The required data is mandatory for the purchase decision at hospitals. The respondents also outlined that training offers would be greatly appreciated. Although service offers are nice to have, they are not crucial decision factors.

Most respondents would use CardiSense as an add-on monitoring and prefer to have the data implemented into current monitors. That would make it easier to compare and analyse the data, having it all handy at a glance. However, it is important that it do not crowd the monitor, that could only complicate things.

The survey gave clear indications on the direction of our clinical study. It stated quite clearly that the two markets are very different, and we need to position ourselves differently. It also underlines that our concept has greater impact on a on sub-groups of patients with highest risk of complications.  We will complete a cost-benefit analysis for this group and address the general cardiac surgical patients after this.

Another key finding is that we need to be even clearer on the benefits and usage of CardiSense. Once it was properly explained the responses were very positive.

We were happy to conclude that the survey also confirmed some of our assumptions and made us sure of our product’s potential. There is currently no monitoring technique available today that can continuously and reliably detect the early signs of post cardiac surgery complications.

Next step now is to do our clinical trial, with the findings of the survey implemented – it will be a better trial leading to a solid product that meets unmet medical need and solves challenges experienced by cardiac surgeons.

We received funding through Norway Health Tech’s EU funded project INNOLABS (691556) to do the survey. It would not have been possible for us to do this without this support and the guidance from Shane West and Cetas.