The Th.D. and Innovation at University Hospitals: Advice From The Wizard of Oz

| 3 March 2015

The Th.D. and Innovation at University Hospitals: Advice From The Wizard of Oz Wizard of Oz: Why, anybody can have a brain. That's a very mediocre commodity. Every pusillanimous creature that crawls on the earth, or slinks through slimy seas has a brain! Back where I come from we have universities - seats of great learning - where men go to become great thinkers. And when they come out, they think deep thoughts, and with no more brains than you have. But - they have one thing you haven't got - a diploma! Therefore, by virtue of the authority vested in me by the Universita Committeeatum E Pluribus Unum, I hereby confer upon you the honorary degree of Th.D. Scarecrow: Th.D.? Wizard: Yeah - that - that's Dr. of Thinkology

The University Hospital is an institution that has served human health well. Virtually every modern medical or surgical innovation was developed or refined in a University hospital. Many of the tools we use every day were invented by basic and clinical scientists who together compromise the faculty of our Universities. The manufacturing and marketing of drugs and devices is done by colleagues in industry. These individuals also play an invaluable role in the innovation cycle. However, many of the scientists and physicians in the BioMedical industries cut their teeth in academia, working in or training at Universities and University hospitals. Indeed, government-funded research, supported by agencies such as CIHR, NSERC and NIH, is a rich source of intellectual property that is ultimately commercialized by industry. So is it a smooth road from Bench to Bedside? Academics discover, Industry creates and commercializes? Not so fast! Not everyone views the modern University hospitals as a laboratory for invention, discovery and experimental medicine (testing of new drugs and devices in patients). The opposition to innovation is indirect and insidious, but quite effective. The enemy of innovation is often the belief that innovation is expensive and not evidence-based (an oxymoron that ignores the fact that research and innovation are the only generators of “evidence”). Some that oppose innovation consider it as a meritorious activity but one that it is best done “elsewhere”. Innovation is disruptive, demands a willingness to change and may incur cost. Siloed budgets mean that a drug or device that saves lives and increases productive life years, such as the stent extractor for stroke (described subsequently in this blog), may simply show up as a deficit on an administrator’s budget sheet. As for “evidence”, a quick review of my textbooks (Meds ‘81) reveals that most of what we knew (our evidence) was wrong or at best, incomplete. Innovation rapidly and completely transforms what we hold to be true. There is, in fact, no tension between the three pillars of a well-run hospital (the practice of evidence-based medicine, the implementation of quality programs, including Choosing Wisely®, and fiscal responsibility) and Innovation. Evidence-based care and Choosing Wisely® reflect the application of earlier Innovation and Discovery (i.e., they are the Knowledge translation fruits of prior research). Some pundits would manufacture a tension between Evidence and Innovation. There is none in reality for evidence-based practice can only follow in the path that research and innovation has broken. Likewise, fiscal responsibility must be judged more holistically…a percutaneous procedure that reverses the damage caused by a major stroke is expensive but is offset by reduced hospital days and the restoration of personal autonomy to the patient. Accounting can be complex and often exposes flaws in the design of our health care system. The expense caused by a new therapy or device used in hospital hits the hospital budget; however, in truth, the deficit of innovation for the hospital is often a huge gain in the outpatient system and may be a bargain for society. This math is not problematic provided the health care system is integrated across in-patient, outpatient and societal registers. For example, the new devices for extracting a clot from middle cerebral arteries are transformative, saving lives and returning people to work. However, these societal savings come at a cost to the budgets of University Hospitals. Clearly innovation is required to make a more integrated way of accounting for the Innovation benefits (and the true cost of failing to innovate). As to the notion that Innovation can be done elsewhere: this is hokum. In Medicine you either lead or you fall behind; there is no holding still in the strong current of medical progress. The best and brightest in all fields aspire to work somewhere near the cutting edge. Try and remain static and your best students and faculty will drift away to your competitors. I would argue that any University Hospital that cannot point to 10 innovative programs in short order is at risk of being irrelevant. While the cost of innovative programs, new drugs and the latest technology may be easily measured, the cost of mediocrity and holding to the status quo is profound-albeit hard to measure. The best students, doctors, nurses, technologists, pharmacists, Department Heads, CEOs, and Deans gravitate to centers that aspire to push the envelope. Offering medical staff the chance to innovate gives them license to be fully engaged and creative. Let’s use our Th.D. training and consider some examples of innovation. I have selected examples from the world of neurology and cardiology. Atrial Fibrillation as a Cause of Cryptogenic Stroke Finding the needle in the haystack: For many years we have used Holter monitors to detect rhythm disturbances. These external monitors work well for 24-48 hours and usually can capture events that are frequent. However, physicians often need longer periods of observation to detect heart rhythm problems that are less common and may occur only after months of observation. These rare heart rhythm problems can have serious consequences. For example we recently learned that many (>1/3) of unexplained or “cryptogenic” strokes are in fact associated with paroxysmal atrial fibrillation.

The new Reveal LINQ from Medtronic, is an injectable loop recorder of the size of a “pen clip” that is placed in the left side of the thorax using a simple syringe (below).

Dr. Baranchuk, a cardiac electrophysiologist at Queen’s University notes, “It requires small amounts of local anesthesia, a Band-Aid and less than 3 minutes for the insertion. It monitors the heart 24/7 for a full 3 years period. KGH is proud to offer this high technology cardiac monitoring to its patients.”

Detection of atrial fibrillation can lead to effective stroke prevention using warfarin or a novel oral anticoagulant. However, the incidence of atrial fibrillation is low in 48 hours and increases greatly when one observes the patient’s EKG for a longer interval, as shown in a study by Dr. Jin and colleagues.

Gladstone and the EMBRACE trial team (including Dr. Jin) performed a study of prolonged monitoring for atrial fibrillation in patients with an unexplained (cryptogenic) stroke. Their study was funded by the Canadian Stroke Network. They discovered that “Among patients with a recent cryptogenic stroke or TIA who were 55 years of age or older, paroxysmal atrial fibrillation was common. Noninvasive ambulatory ECG monitoring for a target of 30 days significantly improved the detection of atrial fibrillation by a factor of more than five and nearly doubled the rate of anticoagulant treatment, as compared with the standard practice of short-duration ECG monitoring.” N Engl J Med 2014; 370:2467-2477 (ClinicalTrials.gov number, NCT00846924.) An accompanying paper in the same June 2014 issue showed that even longer periods of observation, using an implantable monitor (ICM), yielded a 6 folder higher incidence of atrial fibrillation than conventional measurement and concluded “ECG monitoring with an ICM was superior to conventional follow-up for detecting atrial fibrillation after cryptogenic stroke.” N Engl J Med 2014; 370:2478-2486 (Funded by Medtronic; CRYSTAL AF ClinicalTrials.gov number, NCT00924638.) The new injectable loop recorder that we describe above subsequently may offer a simple way of detecting atrial fibrillation in patients with TIAs and cryptogenic strokes. Rhythm without the blues: Earl Bakken was an electrical engineer in Minneapolis who invented the first wearable, battery-operated pacemaker:

Earl Bakken on the development of the pacemaker: Ready Fire Aim

He worked closely with a pioneering surgeon, C. Walton Lillehei at the University of Minnesota. Dr. Lillehei needed pacemakers for his own innovative practice (early cardiac surgery). In the 1950s these devices were large and ran off of electricity from wall plugs. A power failure in Minneapolis endangered one of Lillehei’s patients and he asked Bakken to create a battery-operated device.

Dr. C. Walton Lillehei at the University of Minnesota.

The first battery-operated pacemaker

Subsequently these medical devices evolved so that they could be permanently implanted and this innovative device has saved many lives. Today the placement of a pacemaker is an outpatient procedure. The generators have become smaller, thinner and the batteries lasted longer. However, innovators are never content with “good”. Despite 50 years of evolution, pacemakers in 2015 still require surgical insertion of the battery (a pulse generator) in a pocket created in the left upper chest just anterior to the pectorals fascia. The procedure still requires placement of lead(s) connecting the battery to the heart. These polyurethane or silicone-coated wires travel from the generator, via the subclavian or axillary vein, into the right heart, where they are secured with a screw. This configuration can lead to serious complication in ~5% of patients, including infections of the pacemaker pocket, fracture of the lead and or infection/thrombosis of the lead.

Diagram showing the placement of a conventional pacemaker

Dr. Chris Simpson of Queen’s notes, “One of the Achilles' heels of pacemaker implantation has been infection originating in the “pocket” and another is damage to the tricuspid valve caused by the pacemaker lead. Because there is an incision, the risk of infection is not insignificant and ranges from 0.25-1% for de novo implants all the way up to 1-4% for replacements. Many patients also complain of discomfort related to the presence of a foreign body under the skin and the mechanical friction-related symptoms that can result with movement of the shoulder.” St. Jude Medical is one of two manufacturers who are working on leadless pacemakers, and their offering is now undergoing clinical evaluation in a select few centres around the world, including Kingston General hospital. The new leadless pacemakers are implanted via the right femoral vein, via a catheter delivery system inserted through an 18 French sheath. In skilled hands, the procedure can be completed in 15 minutes, with no incision to care for afterwards. That’s innovation-no leads, no pocket-hopefully faster recovery and few complications.

This Figure shows the miniaturization of pacemakers culminating in 2014 with the leadless device (St Jude Medical).

To watch a video showing how the procedure is done click here. Stroke: We have previously talked about stroke therapies and the role of the multidisciplinary team for stroke care in this blog. Fortunately, accelerating innovation continues to create new treatments for this devastating illness. The ability to treat strokes caused by obstruction of the main cerebral artery took a major leap forward with the application of thrombolytics, like tPA. However, these clot-dissolving drugs do not work well for clots lodged in the M1 branch of the middle cerebral arteries or the posterior circulation. Enter new technologies that are essentially catheters carrying stents that capture the clot that causes stroke and allows the operator to remove the clot mechanically and restore blood flow. This patient presented at the Saint John Regional Hospital, speechless from an MCA stroke that followed a cardioversion.

The prognosis for a patient like this with conventional therapy is very poor. These patients will often still suffer devastating deficits (and this gentleman did succumb to his other comorbidities), but at long last there is the beginning of effective intervention. “Approximately 70% of these patients with strokes like this will end up severely disabled or dead. With these new catheter techniques up to 20% of them will instead leave the hospital and lead independent and normal lives.”, says Brian Archer, an interventional radiologist (Queen's Meds ‘88) who performs these procedures in Saint John. “This is hopefully just the beginning of more innovation in prevention, neuroprotection and … salvage treatments”.

Image shows TREVO device (Stryker). A similar device is made by Covidien (Solitaire). The self-expanding stent is welded to an 0.014 wire, and deployed in the target artery. The operator waits 5 minutes for incorporation of the clot into the stent and then slowly removes the stent and clot, (hopefully) restoring blood flow.

This technology is a great example of the cost of innovation being born by the hospital but the savings to society are huge. Clearly a more sophisticated and holistic form of “accounting” is required to value the return of an individual to life and work; rather than consignment to a life of low quality spent in an institution. This is a technique we do not yet offer at KGH but it is sweeping across the country. For a review of the literature on the 3 trails showing benefit from thrombectomy for certain types of stroke see an excellent blog by Larry Husten. I am impressed with the investments the Saint John hospital made to allow their stroke program to thrive...notably including the construction of a state of the art hybrid room that allows them to conduct these procedures:

Hydrid Room in the Saint John Regional Hospital

It’s in your hands now, doctor: In a former life, I used to direct an ultrasound laboratory in Minneapolis. I LOVE imaging. It's amazing to see the advances from M-mode to 2-D imaging to colour imaging and now 3-D imaging of the human heart. The latest innovation is moving the cardiac ultrasound into the doctor’s pocket. Dr Amer Johri and team are now teaching our medical students and residents how to image the heart and make cardiac diagnoses at the bedside using hand-held ultrasound units that are not much larger than an iPhone 6. Watch this CTV news story. If you were trained in the 1980s, it makes you wish this innovation had been around as you struggled to hear that soft murmur of mitral regurgitation. It is noteworthy that patients consider this type of miniaturization and portability to be a tangible manifestation of patient-centered care. Dr. Johri and his team of residents and medical students working for the CINQ recently developed a free training module using the iBook format which can be found here.

Dr Amer Johri, Assistant Professor of Medicine (Cardiology) and Jeff Wilkinson (Cardiology Resident) using hand held ultrasound to image a patient.

In closing, University hospitals exist to discover and innovate. Each of us, as faculty members or administrators, is responsible for doing our part to help make these discoveries or to create the environment where discovery and innovation are welcomed and supported. In 2015 we are tasked with creating the “Evidence-Based Medicine” of 2020 and training the physicians and nurses that will create the “Evidence-Based Medicine” of 2030. It is time to use our Th.D.s and accelerate innovation for the benefit of our patients. If you want a booster shot to reinforce the latest in Innovation at Queen’s, plan to attend the Department of Medicine’s Second Annual CME Day on May 13, 2015. This event promises to bring together leaders in medicine from Kingston and Area. Attendees will have the opportunity to work together in a variety of formats. This year, in addition to sharing pearls of innovation, the event will offer SIM lab experiences, interactive workshops, and a fun and educational Jeopardy-style challenge to wrap up this exciting event! A full program for the event and registration information can be found here.