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“Why Cleveland Clinic Believes It Can (at Least) Triple a $1.5 Million Investment in This Startup”

http://www.inc.com/ilan-mochari/cleveland-clinic-startup-tatara-vascular.html

Thoracoabdominal stent grafts off the shelf: link

Congratulations to Dr. Gustavo Oderich who has implanted the Gore off the shelf TAAA device at Mayo.

The VEITH Symposium has been my favorite meeting since I was a junior resident back in the 90’s. This year is no different. I finally figured out why I like it so. VEITH is organized like the Iowa State Fair with all the charms and chaos that makes that fair one of the top 10 things to do in the US. There is the location at the Hilton Midtown which puts it in the center of all the commercial and tourist chaos that makes NY amazing. It is a high end version of the midway at the Iowa State Fair on East Side night, but instead of fried Snickers and bad teeth, you have perfectly crafted international foods and people from everywhere. Like the Iowa State Fair, everything is happening at the same time and you have to plan out your day in great detail. And there are the must sees like the debates between the giants of the field and the 20 surgeon panels sitting on stage no different from the 1000 pound pig and the handsomest cow. Then there is industry, but rather than tractors in green or blue flavors, we get seven different kinds of stent grafts at my last count. You learn how to pick out the signal from the noise, not always by counting the N of individual papers, but in the trends of the numbers of presentations that generally agree, like the hot new Fair food that catches and gets easier to buy every subsequent year. A true free market of ideas. And finally, like you can run into friends who moved to Dubuque, you run into people who were important on your life path, Jedi and Sith masters and padawans, and you have large unhealthy dinners together. What’s not to like? Next year, at VEITH!

The picture above shows a vascular anastomosis created by an ingenious gadget that has struggled to find a place in my personal kit despite performing well. It really works well when you don’t have an assistant to follow your running suture to apply tension and keep the suture out of the way. I have have come up with four reasons why I don’t use it every day even though I like the device, find it performs well, and have used it in the past.
1. Training Vascular Surgeons- The vascular anastomosis is over a century old, and the various forms it takes, interrupted suture, continuous, end to side, end to end, side to side, native to prosthetic and so on, all have to be taught so that the trainee can function even in the absence of such gadgets.
2. Cost- The cost of the device is subsumed by the hospital and ultimately the healthcare system. Using the device is the equivalent of turning the air-conditioning on when opening the window will do.
3. Time savings- If operating room time were metered like taxi time, then there might be an argument for this device, but the difference in the end is still trivial. A hand sewn anastomosis, even done slowly, takes usually no more than 20 minutes. Using this device, the times are reduced to about 1-5 minutes. This almost never is enough to make a difference, unless ischemia sensitive tissues are being repaired, but no one would use this device to sew a graft to a renal artery.
4. Results- The argument that an interrupted anastomosis is superior to a running one only works when native tissues are sewn to native tissues. A prosthetic to artery anastomosis will not adapt and frankly is the easiest to create a technically acceptable anastomosis with. An interrupted anastomosis done by hand can be done in as much time as a running one (figure below).

There are many wonderful and ingenious inventions like this. Whole specialties and institutes are built around implantation of ingenious and life saving devices. Yet the costs are increasingly astronomical and unsustainable.

Can there be innovation without sticker shock? The answer is a qualified yes. To make this a reality, there has to be several changes in the way that devices and procedures are vetted and approved. It will not be easy.

To bring a new drug to the market, the Tufts Center for the Study of Drug Development estimates in 2014 that it costs $2.5 Billion. This barrier which we have erected against ourselves insures that pharmaceutical development is channeled through a narrow group of players. On the device side, there are similar barriers and price tags to bringing a discovery to market. There is a six letter C-word to describe this situation, but it isn’t polite to use.

It used to be that breakthroughs in surgery were not directly monetizable. The carotid endarterectomy didn’t make DeBakey or Eastcott anything but fame among a small group of surgeons, but there was great good from that. A lot of time and effort and money has been used in an effort to supplant the carotid endarterectomy with carotid stenting, but the devices come at a greater cost for dubious benefit except in very particular situations. I recently performed an eversion carotid endarterectomy in about an hour’s time closing with no patch or shunt. The procedure cost the price of 6-0 suture to repair the artery, and several packs of an absorbable suture to close the skin. Add to this some disposable drapes, suction tubing, a cautery and an energy device. Compare this to a carotid stent procedure that uses a stent (4 figures), wires (up to 4 figures), protection device (4 figures), sheaths, balloons and catheters (3-4 figures), resulting in upwards of 5 figures of cost. This is for a procedure that in head to head comparisons results in a higher stroke rate, the very complication it is meant to prevent.

Health care innovation will have to have cost disruption as a necessary condition for its adoption. Whatever is used, has to drop the cost by removing a zero from the end of the price tag while yielding at least as good or better results.