My name is Santiago Garcia. I'm an interventional cardiologist at the Christ Hospital in Cincinnati Ohio.

Could you tell us about the PASCAL System?

The PASCAL Precision System is a novel device that was introduced commercially in the United States two years ago. It has four salient features: it has a central spacer, it has a [illegible] configuration, it has the ability to completely elongate and that helps navigate dense chordal structures in the [illegible] apparatus, and finally, it has a single row of frictional elements that is designed to lead to atraumatic leaflet clasping.

What was the study design and patient population?

This was an observational study that leveraged on the capabilities of the STS/ACC TVT Registry. This is an important tool for post-market approval of new technologies in the United States. So we leveraged that registry, included about 2,000 patients treated over a two-year period at 181 sites, with access to this technology.

The key results, the key takeaways of this observational study are as follows. Number one, device success was very high: 97%. Serious adverse events, intra-procedural such as single leaflet detachment, mitral valve intervention and surgery were very uncommon: less than 1%.

And finally, safety events of 30 days were also very favorable with cardiovascular mortality of around 1%, stroke of around 1% as well and low rates of rehospitalisation for heart failure.

What are the key outcomes?

Well in addition to clinical outcomes, we obviously wanted to look at the effectiveness of this device in terms of reductions of mitral regurgitation. And we observed that at 30 days sites reported that 72% of patients had mild or less mitral regurgitation which is remarkable. And 94% of patients had two plus or less mitral regurgitation. This is the population of patients with primary mitral regurgitation.

All of these patients had either primary MR or mixed DMR and functional mitral regurgitation in about 11% of patients. The device right now has a narrow indication for patients who are at prohibited risk for surgery. And about 2/3 of these patients had at least one feature of anatomical complexity. So given those characteristics I think the degree of MR reduction that we have seen is remarkable.

In terms of improvement in symptoms, the majority of patients, 80 plus percent of patients, were in New York Heart Association Functional Class I or II at 30 days. And there was a significant improvement in quality of life as measured by the Kansas City Cardiomyopathy Questionnaire overall score, which increased on average about 20 points between baseline and 30 days.

What are the potential clinical implications of these findings?

We always look at new technologies with interest when they roll out from the clinical trial setting to the commercial setting to make sure that the results can be generalisable to the general population. And I think the answer is unequivocally yes.

We have seen results, at least in the first two years, of this technology rolling out to the US Market that are very encouraging and in line with what was seen in the CLASP IID trial.

What further study is needed, and what are the next steps?

Well, there are two ongoing studies looking at this technology, the PASCAL Precision System, in patients with functional mitral regurgitation. These are patients that have regurgitation as a consequence of cardiomyopathy.

They have different anatomy, different substrates. That study is still ongoing. And then there is also the CLASP II TR, which is looking at PASCAL Precision System as a therapy for patients with severe tricuspid regurgitation. So, those are very important studies that hopefully will be presented soon, hopefully next year.