This content is only for readers outside of the US as it discusses a device that is not FDA approved.
On February 12, 2019, Edwards Lifesciences received the CE mark for its PASCAL transcatheter valve repair system for managing mitral regurgitation.1 In this article, Cardiovascular News reviews how the system works and speaks to Dr Stephan von Bardeleben (Head of Heart Valve Center Mainz, Center of Cardiology, University Medical Center, Mainz, Germany) about his experience with the PASCAL repair system.
The PASCAL implant consists of a central spacer that is designed to fill the regurgitant orifice area and with paddles that are intended to maximise coaptation and reduce stress on the native leaflets. The implant also has clasps that allow for independent leaflet capture and offer the possibility to finetune leaflet positioning.2 Furthermore, its 22F delivery system includes independent catheters that enable simplified manoeuvring in three planes, and stabilisers that lock handles in place for procedural ease.
Dr von Bardeleben says the PASCAL repair system is an “innovative step towards treating mitral regurgitation”. He explains that a major benefit of the central spacer is that the operator does not have to “pull the leaflets of the mitral valve as far together as you would with a conventional surgical approach or already available transcatheter systems”. He adds that the paddles, which go on the outside of the valve, (“together with the spacer”) help repair the valve in its coaptation deficit and better distribute the forces of the system over a larger area of the native valve leaflets. “That is a very important part of the system,” he notes. Furthermore, the paddles flex on every heart beat “so that the system dynamically flexes as the valve opens and closes”.
According to Dr von Bardeleben, the independent clasping function of the PASCAL repair system also has unique benefits: “We can individually control each side of the clasp mechanism, which is completely new to the market. This means that we can reopen one side of the clasp while keeping the other clasp in its fixed position. This allows you to move the system to the more defective, weaker leaflet, optimise its capture and reclose the system for optimal results. This independent leaflet capture feature enhances the efficacy of the PASCAL repair system,” he explains.
As with all transcatheter systems, the PASCAL repair system is a less invasive approach for patients. For example, the entry point into the groin is 0.7–0.8cm, whereas the smallest access for a surgeon is 3–6cm (which would be regarded as “a small approach” in surgical terms). Additionally, the patient is immediately extubated after the procedure (while still in the cath lab) and sent to a normal ward. There is no need for pain medication (unlike with valve surgery), the patient can already be mobilised within 12 hours after the procedure, and they can be discharged after two days. Dr von Bardeleben says, “We make sure there is no bleeding and no issues at the puncture site and then the patient can be discharged. We have even had patients aged 82 years leave two days after implantation. The patient will not see anything from the procedure after one week, not even a scar. They can go back to their normal activity within five days.”
Planning and performing transcatheter valve repair with the PASCAL repair system
The Heart Valve Center Mainz has performed 22 implants of the PASCAL repair system overall—including 13 procedures after the CE mark was granted. In line with the 2017 European Society of Cardiology (ESC) guidelines for valvular heart disease, in its capacity as a heart valve centre of excellence, a multidisciplinary heart team makes the decision about whether a patient is a suitable candidate for undergoing transcatheter repair with the PASCAL repair system.3 Dr von Bardeleben explains: “In our heart team, there is an interventional cardiologist [Dr von Bardeleben], a cardiac surgeon who has experience of performing mitral valve repair, a cardiac imaging specialist, and an anaesthesiologist. Sometimes, we also have a geriatrician or a heart failure specialist.”
Prior to implanting the PASCAL repair system, the Heart Valve Center Mainz heart team assesses the patient to exclude and/or control coronary artery disease. They then use transthoracic and transoesophageal echocardiography to plan the procedure. During the procedure itself, transoesophageal echocardiography is used alongside fluoroscopy (according to Dr von Bardeleben, the ratio is 80% to 20%, respectively). Dr von Bardeleben says that the transoesophageal echocardiography “gives us brilliant images of the mitral valve, which is 5cm to 6cm away from the oesophagus”, adding that the image quality is so good “that it is like a virtual Hollywood movie”. Of note, contrast is not needed, and this makes implanting PASCAL “a soft and harmless procedure for the renal function of the patient”.
The typical patient who receives transcatheter valve repair either has functional mitral regurgitation between 50 and 90 years of age, or is an older patient with degenerative mitral regurgitation disease. However, at the Heart Valve Center Mainz, so far, patients who have undergone transcatheter valve repair with the PASCAL repair system have been between 75 and 92 years of age (with either degenerative or functional mitral regurgitation). Dr von Bardeleben comments: “In all cases, the PASCAL repair system was easy to implant because of the ease of use, the ability to manoeuvre, the independent clasping, the elongation ability and the contoured paddles.” If heart centres are looking to start implanting the PASCAL repair system, Dr von Bardeleben believes the learning curve depends on the operator’s experience. He notes that, compared with valve surgery, transcatheter procedures are “unique” and imaging training is needed to guide the procedure. “With the PASCAL repair system, the training concept is that you will become an experienced implanter within 15 to 20 procedures if you do not have already advanced experience of implanting transcatheter therapies. But if you have prior experience, you can become very experienced after 10 implants.”
In his experience of implanting the PASCAL repair system, Dr von Bardeleben has seen an immediate change in patients after the procedure. “Typically, we see a rise in blood pressure—blood pressure is one of the quality assurance controls—and we also typically see a reduction in pressure in the left atrium by about 6–9mmHg. Using colour Doppler, we observe a reduction in effective regurgitant orifice area.” He adds that, following the procedure, New York Heart Association (NYHA) functional class values “go back by one or two grades” and patients are able to “perform better” without experiencing dyspnoea. “The six-minute walk test is important to evaluate the exercise capacity of the patient. We do a baseline six-minute walk test and patients are usually able to walk 250m. But after the procedure, we see these distances increase by about 40m to 80m.”
When Cardiovascular News spoke to Dr von Bardeleben (April 2019), he had one-month follow-up data for the first five patients with functional mitral regurgitation who received the implant after the CE mark was granted. He says that they are all “doing very well” and have “trace to mild grade residual mitral regurgitation”.
1. Cision PR Newswire. Edwards PASCAL Transcatheter system receives CE mark. https://prn.to/2ShEB4D (date accessed 5 April 2019).
2. U Schaefer. Early outcomes from the multicentre, prospective study with the novel PASCAL transcatheter mitral repair system for patients with mitral regurgitation. DGK 2019.
3. H Baumgartner, V Falk, JJ Bax, et al. 2017 ESC/EACTS Guidelines for the management of valvular heart disease. European Heart Journal 2017; 38: 2739–91.