The Oft Forgotten “Innovation” in Patient Centred Care: Curing Atrial Fibrillation through I-PCC

| 5 September 2017

Atrial fibrillation affects 350,000 Canadians and triples risk of stroke-Heart and Stroke Foundation Patient Centred Care (PCC), a phrase that means different things to different people. Too often it is used as code for health care delivered in a convenient location and/or delivered competently in a courteous and timely manner. These are unequivocally attributes of PCC. However, there is an often-overlooked foundation of PCC that is particularly relevant to academic medical centres, such as Kingston Health Sciences Centre at Queen’s University (KHSC-QU). Here PCC also means providing the patient with very best in diagnostic modalities and therapeutic options. You see the difference in these definitions? Offering a leech or blood letting to a patient with heart failure due to atrial fibrillation (AF) in a courteous and prompt matter is not PCC; offering a procedure to cure the rhythm problem would be both innovative and patient centred. Let’s refer to this latter option as innovative patient centred care (I-PCC). Of course, one would also hope the curative I-PCC procedure would be offered locally in a timely and courteous manner. Is this PCC vs I-PCC distinction just semantics? No, because if an academic medical centre aspires to offer I-PCC (innovative patient centred care) it requires vision that must be reflected in the hospital’s mission statement because providing I-PCC is neither easy nor cheap. To provide I-PCC academic medical centers must invest in state of the art technology and their partner Universities must hire world-class clinicians and scientists. These are both tall orders. Hospitals are budget-constrained and Canada is not training sufficient numbers of the medical and surgical specialists required to meet our needs (in my opinion). Once you embrace I-PCC the search for new hospital funding streams and the hunt for medical and scientific talent becomes continuous. The flame of ambition that drives us to innovate must be fanned as it is easily extinguished by a nonresponsive bureaucracy. Let me illustrate I-PCC by telling the story of a patient with a very common but troublesome heart rhythm problem, permanent atrial fibrillation. I could have used any number of examples, such as live donor renal transplantation, allogeneic bone arrow transplantation, transaortic valve replacement, epilepsy surgery. In each case, conventional care offers some benefit and one would hope could be delivered in a patient centred manner. However, in many patients conventional care will yield suboptimal results. In the case of a patient with AF, conventional PCC may result in poor control of rhythm or heart rate and/or expose the patient to adverse drug reactions. By assembling a team of innovative physicians, nurses and technologists in a state of the art electrophysiology laboratory we can now often eliminate the atrial fibrillation. In this story a patient with chronic AF is cured by a hybrid procedure involving the combined efforts of a cardiac surgeon and electrophysiologist (cardiologist). This blog offers the back-story of a first-in-Canada hybrid procedure. We have become rather nonchalant and perhaps even cynical about news stories describing medical innovations. Often the news flash, “Doctors at your favourite hospital have discovered this or cured that” is met with apathy. When you hear this headline do you think of the passion, the human capital, the funding and the organization required for this “cure” to have occurred? Unless the I-PCC affects us or a loved one we often fail to consider the back-story. Indeed, unless physicians and medical centres that have embraced I-PCC they may be unaware of new and improved diagnostic and therapeutic options. When we hear a story of medical innovation we would do well to ask 8 simple questions:

“Why is (or isn’t) this being done at my hospital?”
“Who are the doctors that did this and where did they train?”
“How did they get the idea to do this?”
“Is this funded by the ministry of health and long term care (MOHLTC)?”
“What challenges did the team overcome to perform this procedure?”
“Who was the brave patient who had the procedure performed?”
“Did it really help the patient?”
“Are there clinical trial data to support this new procedure becoming the gold standard?”

Before meeting our patient a primer on AF. AF is the world’s most common heart rhythm problem. It can cause minor symptoms (palpitations), major cardiac dysfunction (congestive heart failure) or lead to stroke. The heart normally functions as a two-stage pump. The electrical system activates the heart in a coordinated sequence. In the normal heart rhythm (called normal sinus rhythm-NSR) the upper cardiac chambers contract when they are stimulated by electricity from the sinoatrial node of the right atrium. After an appropriate delay, the atria fill the ventricles muscular lower pumping chambers that deliver blood to the lung (right ventricle) and body (left ventricle). The electrical activation pattern that ensures coordination of blood flow from the upper and lower chambers in NSR can be seen on a simple EKG. The atrial contraction is triggered by a “P-wave” (see EKG below) and then the ventricle is triggered to contract by the “QRS complex”. The delay between the P wave and the QRS complex is mediated by the AV node (see-diagram of heart below), a special tissue that slows electrical conduction so that heartbeats don’t come too swiftly. The AV node allows time (the PR interval) for the mechanical filling of the ventricle from the atrium. In AF the P-wave disappears and the atrium fibrillates (wiggles). The loss of the atrial contraction can reduce total cardiac output by a third! This often causes fatigue or shortness of breath and can lead to heart failure. In addition, in AF the atrium generates hundreds of abnormal electrical signals per minute. These electrical waves bombard the AV node and too many of these signals pass through, causing the patient to experience a fast and irregular heart beat (palpitations). Decorative Image In addition, the reduction of atrial contraction causes blood to pool and allows clot formation. The Figure below shows clots in the left atrial appendage. When these clots dislodge strokes can occur. The annual risk of stroke is increased 6-fold by AF. Although AF is not usually lethal it is a significant problem and we (the medical profession) are officially in favour of preventing or eliminating AF! The approach to AF begins with prevention (keep your heart healthy-exercise, minimize alcohol use, avoid smoking, and stay lean). If one has AF we can take a rate control approach and use medications to slow the rate heart (by slowing electrical conduction through the AV node (e.g. metoprolol or diltiazem) while preventing blood clots using anticoagulants, such as warfarin, or newer drugs, called NOACs (e.g. rivaroxaban). Alternatively, we can take a rhythm control approach and try and restore NSR. Sometimes we can restore sinus rhythm by electrical cardioversion (a shock delivered while the patient is sedated) and/or by the use of drugs that sustain sinus rhythm (such as amiodarone). However, cardioversion doesn’t not work well in chronic AF and the drugs that maintain sinus rhythm are even less effective and bring with them a host of complications. In the last decade cardiac electrophysiologists, a specialized type of cardiologist have developed catheter based techniques that allow restoration of NSR in many patients. They use sophisticated electrical mapping systems to identify the anatomical origin of AF within the left atrium. They then hunt the arrhythmia down and determine its origins. Using a specialized catheter that delivers low temperature or microwave energy they then destroy the offending atrial tissue and “ablate” the AF. This works ~60% of the time and, when it works, may improve life style and allow the patient to stop many medications, a clear example of I-PCC. However, AF ablation often fails when patients have long-standing AF in whom the abnormal drivers of AF are often spread diffusely and are buried deep within the heart, inaccessible to transvenous ablation catheters…the case in our patient! So, now that you are an honorary cardiologist, let’s hear from the patient, Mr. Ellis

Decorative Image

Mr. and Mrs. Ellis

Mr. Ellis is an avid gardener, camper, grandfather and great grandfather. He enjoys an active lifestyle and is a passionate repairer and tuner of pianos. His quality of life decreased drastically 8-years ago when he developed AF. He was often exhausted and had reduced stamina. He struggled to keep up with his piano passion and recalls being exhausted just looking at the stairs in his house. He persevered but life became more difficult. In May 2017 Dr. Bisleri from KHSC-QU called Mr. Ellis to inform him that he was at the top of the list for a new therapy for patients with chronic AF. This new procedure is called an AF Hybrid Ablation. The procedure is offered by Drs. Bisleri, a recently hired cardiac surgeon from Italy, and Dr. Ben Glover, a cardiac electrophysiologist, recently recruited from Ireland. Mr. Ellis and his family were told that this new procedure is performed in the operating room and allows the team access to both the inside and outside surface of the heart simultaneously. This allows them to better reach (and ablate) the electrical “short circuits” that allow atrial fibrillation to persist. Mr Ellis was thrilled to accept the surgery. In June 2017, Mr. Ellis had the procedure. He was in the hospital for 3 days post-surgery and returned home to continue his recovery. The surgery eliminated the AF. He now feels stronger by the day. This is I-PCC. Mr. Ellis noted that “Drs. Bisleri and Glover and their nursing staff were tremendous. The surgery was well explained and the utmost attention was given to making me feel comfortable.” This is conventional PCC.

Now click the above image to hear from the doctors who led the team and performed this unique procedure. Drs. Bisleri summarizes their work as follows: “This procedure allows the operator to access the inside surface and the outside surface of the heart so that we can create deeper burns across the heart and more successfully target short circuits in areas which were previously not easily accessible. We hope that this will allow us to increase the success of the procedure. This should result in an improvement in patients symptoms and potentially allow us to close areas of the heart where clots are more likely to form.” The latter comment refers to surgical closure of the left atrial appendage, which is where most clots form in AF (as seen in the Figure above). By closing the appendage stroke risk should be reduced. “By combining technology with the knowledge and expertise of our medical teams, we are able to treat complex cases with a high success rate in a minimally invasive manner, notes Dr. Glover

Picture of procedure from KGH Connect

Below is the electrical map of the left atrium showing the success of the procedure. Decorative Image

A map of the electrical activity in the left atrium.

This image shows electrical isolation of the back wall of the left atrium, including the pulmonary veins where the short circuits (potential triggers) that atrial fibrillation often originate. This electrical map is recorded from specialized wires positioned within the heart. Regions in red were electrically disconnected from the rest of the left atrium (seen in the other colours) by the hybrid ablation. This isolation prevents the initiation of atrial fibrillation Returning to the backstory and how this example of I-PCC came to KHSC-QU, let’s answer the questions posed earlier in the blog. Why is (or isn’t) this being done at my hospital? This procedure is being done based on the recognition by the team of doctors and their colleagues that the standard therapy was inadequate. Their ambition and passion led them to innovate to create a treatment that offered a patient centered procedure customized to meet the needs of Mr. Ellis and people like him. To be clear they were not told to do this procedure nor are they differentially reimbursed for doing it. The impetus originates from curiosity and a passion for improvement in the care they deliver. Who are the doctors that did this and where did they train? The point may be controversial, but as a Canadian, trained at Queen’s University I believe we are not training highly specialized physicians in adequate numbers to allow domestic recruitment of the type of faculty required to envision and implement these innovative PCCC programs. I say this having hired over 30 new faculty members since beginning my term as Head of the Department of Medicine in November 2012. Witness the fact that the Department of Surgery had to recruit Dr. Bisleri from Italy and I had to recruit Dr. Glover from Ireland. Generalism is in fashion in the training of doctors in Ontario and generalism certainly is important to the health of the populace as a whole. However, as Medicine offers more and more innovative and definitive cures, Medical schools and residency training programs need to provide increased numbers of sub-specialty oriented trainees. This is only controversial in the abstract. When one is sick oneself the value of the “super-expert” is intuitive! Decorative Image

An Italian Physician and an Irish Physician Team up to Perform a Canadian First

How did they get the idea to do this? The procedure is a hybrid of arrhythmia surgery and catheter ablation. Arrhythmia surgery for AF is often anatomically based and is done without direct electrophysiology physician collaboration. Its limited success relates in part to failure to map the origin of the AF and confirm that it is truly ablated. Pure catheter based techniques are guided by exquisite mapping but often can’t reach the arrhythmogenic target tissue safely. A hybrid is logical and only required two colleagues to focus on the good of the patient and put aside speciality turf to devise a solution that was truly patient centred.

Does the Hospital receive MOHLTC funding for this procedure? No specific funding exists yet for this program. Indeed, hospitals are challenged to offer such costly therapies in the absence of targeted innovation funding. Often programs like this begin with deficit funding or rely on seed money from Hospital Foundations. Eventually, if the MOHLTC determines the procedure is the standard of care they may provide funding. It is reasonable that broader evaluation of this complex and expensive technique be performed to better define the cost/benefit ratio and present the MOHLTC with a case for funding. However, an innovation fund to pilot new procedures would be an ideal catalyst to allow academic medical centres to test candidate forms of I-PCC. What challenges did they overcome to perform this procedure? This step forward would not have bene possible without over a decade of investment in our Cardiac Sciences program, specifically in the building a complex arrhythmia service and our cardiovascular surgical Division. This program required cooperation of academic Department Heads (Surgery-John Rudan, Anesthesia Joel Parlow, Diagnostic Imaging Annette McCallum). It involved support from leaders of the Cardiology Division in the Department of Medicine (Dr. Chris Simpson and more recently Dr. Cathy McLellan) and the Cardiovascular Division of Surgery (Dr. Andrew Hamilton and more recently Dr. Dimitri Petsikas). It required visionary leadership for the electrophysiology program (Dr. Damian Redfearn and more recently Dr. Ben Glover). It required the hospital to build and staff a state of the art electrophysiology laboratory and the electrophysiology team to perfect their use of catheter-based ablation of AF. Who was the brave patient who had the procedure performed? You have read Mr. Ellis’ story. Kudos to him for having the trust/courage to be an early adopter of a promising therapy which was aimed at helping him. Did it really help the patient? It is early days and the proof that this procedure is superior to standard care will require evidence of sustained benefit. Moreover, clinical trials are needed to determine which patients benefit from the procedure and whether the risk/benefit ratio (relative to conventional therapy) is favorable when the procedure is applied more broadly. Are there clinical trial data to support this new procedure becoming the gold standard? To become the gold standard this procedure will no doubt require randomized clinical trial assessment and/or be evaluated in a case registry. Similar evaluations have occurred with technologies such as percutaneous placement of aortic valves, TAVI also started as locally funded initiative and evolved over time to become standard of care, MOHLTC-funded program. However, if academic medical centres fail to adopt these programs early on they often are left behind when provincial funding is made available. Thus, a culture of innovation in academic medical centres and their University partners is required to support I-PCC. In conclusion, the story thus really began long before the headline with the recruitment of talented physicians, the equipping of the hospital with state of the art equipment and the creation of a culture that challenges the status quo and values medical innovation. KHSC is about to build a new wing to modernize KHSC, the so-called Phase 2 project. The community and government will partner in this $600 million expansion. At the heart of the bricks and mortar are the rooms, technology and people who will invent and deliver new programs of innovative PCC. Stay tuned and be prepared to advocate and donate to the cause!