Abstract
Interview by Louise Rishton (Commissioning Editor) and Tanya Stezhka (Assistant Commissioning Editor)
Ganesh Manoharan graduated with Distinction from Queens University of Belfast (UK) in 1993. He completed his training in Cardiology in Belfast and his Advanced Interventional Cardiology Fellowship at the OLV Hospital, Aalst, Belgium. He was appointed as a Consultant Cardiologist at the Royal Victoria Hospital (Belfast, UK) in 2004. Since 2004, he has written service development business cases towards successful implementation of four clinical procedures in Northern Ireland, namely the use of rotational atherectomy (Rotablator®), intracardiac ultrasound (Accunav System®), increased use of PressureWire™ and, more recently, transcatheter aortic valve replacement (TAVR). Dr Manoharan is the clinical lead for the TAVR programme in Northern Ireland and functions as a Clinical Proctor for the Medtronic CoreValve® and the St Jude TAVR Programs. He has successfully started up and trained over 50 Regional Cardiology Centres in Europe, Asia and Australia, and has been involved in over 1000 cases to date. Dr Manoharan also functions as the Educational Supervisor for Cardiology and supervisors both Clinical and Research Fellows. He is actively involved in clinical and experimental research, with numerous publications.
What attracted you to a career in cardiology?
Cardiology presented the opportunity to specialize both in areas of clinical management and in areas that involved a lot of technology for treatment. It also allowed me to use my hands, which is something that I enjoy.
I also found it to have areas with many evolving and emerging subsets, making it quite multifactorial.
Finally, within medicine, it is the cardiovascular field that has arguably the largest amount of data and trials and is home to surely the most number of ‘toys’ for improving patient care.
What would you consider to be your greatest achievement to date?
Professionally, to have brought new and potentially quite groundbreaking therapies to patients in Northern Ireland and the rest of the world.
How did you get involved with transcatheter aortic valve implantation trials & the transfemoral delivery procedure?
When the device first became available commercially 5–6 years ago, we saw it as a procedure to suit our patients and the scope of our department. Our results were good and this in turn resulted in the procedure being funded and approved for use. I then took a sabbatical year t in 2009 to teach and train other clinicians around the world on how to perform transcatheter aortic valve implantation (TAVI); with the CoreValve® system (Medtronic, MN, USA). It was an awesome time of my life and it provided exposure to various individuals and companies. One thing led to another and I am now involved in the new Portico™ (St. Jude Medical, Inc., MN, USA) trial among others. It is a very exciting period.
In terms of the Portico trial, there have been a few modifications to the valve. What do you think are the main benefits of the new valve?
In my view, the key benefit with this device is that you can fully resheath and reposition the valve while you are inside the patient. I think this transfers a certain degree of comfort – the clinician is reassured that if they are not absolutely happy with the positioning on the first attempt, they have the ability to have another go.
The Portico valve currently uses the transfemoral delivery system. Obviously there has been a lot of interest recently in the route of delivery with percutaneous interventions. Do you think the transfemoral method is superior for patients?
I guess the other way of answering this question is that if I was a patient, I would like a procedure I underwent to be as noninvasive as possible, as long as it was safe. The transfemoral approach has been shown to be safe and can be done when the patient is fully conscious under local anesthetic. Other methods are also available and we need to match the right method to the right patient. In our institution, we have a stepwise method that is linked to invasiveness. We discuss each patient at a Heart Team meeting where all cases are discussed in detail: angiograms, echocardiogram and other data are evaluated and all possible access routes are reviewed so that surgeons are fully prepared for all situations.
Would you say it is a system based on the patients?
Yes. Naturally, patient-directed therapies are the preference of the individual. We have developed our unit to ensure we are able to provide any route required for the best outcome for the patient.
What do you think the main goals were when the new valve was designed?
St. Jude’s is traditionally a surgical company and very well linked to surgical approaches for valves. I suspect when they were developing the valve 4–5 years ago, their thinking process was to try to create what surgeons are able to do today – that is, locate the area and position the valve, try it out for size and if necessary, reposition it comfortably.
So, trying to recapture the surgical replacement approach with transcatheter methods?
All the devices are gearing towards that goal. It is about making it as precise as possible with surgical intervention, while making the procedure as noninvasive as possible. To make devices that are intuitive, easy to use, predictable, adaptable for the particular anatomical location and assessable for all patients.
What does TAVI mean for patients with severe aortic stenosis?
Well, with data in the field at the moment, if a patient can receive a valve replacement surgically, then that is the best option for the patient. This is what guidelines say and this is what we observe in the clinic. If we have a young patient that is healthy with no comorbidity, they do very well with open heart surgery. However, in patients that are high-risk for surgery, the transcatheter valve replacement procedure then offers them a new lease of life and the ability to live.
Do you think there are any wider benefits to this procedure? With the recent interest in patient-centered outcomes and cost–effectiveness, what are your feelings on how this relates to TAVI?
The most expensive thing at the moment is the valve itself. Bearing in mind that TAVI is a 7-year-old procedure, it’s early days in terms of truly understanding the costs of the procedure. Nobody is going to offer a groundbreaking, life-changing technology for nothing. There has been a lot of money in developing these technologies and the trials that are still required require money to run from somewhere. Therefore, companies will have to get the balance right between profits and using them to fund next-generation devices and trials. However, patients are now using the third transferomoral CE-marked device on the market and I predict there will be many more over the next 2–3 years. This will create competition, which always works to bring the price down or improve technologies. This will ultimately help clinicians like me in making sure that patients receive the best devices at the right price.
Where do you see the field heading in the next 10 years? What do you think of the move toward widening patient selection for TAVI?
At the moment, the guidelines and commercial funding process has TAVI for patients who are surgically unsuitable. There are ongoing trials that include moderate-risk patients guided by the Society of Thoracic Surgeons’ score or the Euroscore and the results will be released in the next 2–3 years. Data will guide what we end up doing in time but I suspect we will end up treating lower risk (but elderly) patients via TAVI.
As the technology develops, do you think clinicians will be more willing to transplant TAVI in more patients?
I think these trials will be very important in deciding what is safe and what is reasonable. With the developing technology, if the clinician can predictably carry out the procedure in all patients with good results, ultimately I suspect well-informed patients will make the choice. Medicine has always been about informed consent. If the guidelines and the results suggest it is just as effective as open-heart surgery and the cost–benefit ratio is also acceptable, than I think patients may prefer TAVI.
In the next 2–3 years, in my view, it is very important that clinicians make sure that guidelines are adhered to, and do not push the boat out ahead of the data and the trials. I think this will guide the technology to where I believe it should go and ensure that we carry out our responsibilities to the technology and to our patients. I think today, any clinically moderate-risk patient given TAVI should be included in trials and we should not just administer the procedure at the whim of the patient or the clinician.
How has the field of valvular surgery changed over the last decade?
I think most obvious of all, the devices have changed. I think both surgical techniques and anesthetic techniques have improved significantly but also the ability to select appropriate patients has certainly improved. I think that a combination of these factors have improved surgical outcomes.
How has the last year been for you professionally?
Extremely busy; but, it has been good busy. It is what I wanted to do. I have a registrar who joined us last year and whenever I ask him how his day has been, he answers, “living the dream”. My answer would always be the same. All cardiologists want to be involved with new advances and technology and being part of that experience is phenomenal.
What does the following year look like for you?
Hopefully much of the same. There will be a lot of new devices coming out. I think mitral valves will be the big thing this year.
Financial & competing interests disclosure
The author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.
Editorial assistance was provided by St. Jude Medical, Inc. (MN, USA).