Cardiovascular Revascularization Medicine 12 (2011) 271–272

Guest Editorial

Innovation in interventional cardiology: a thing of the past?

Every week it seems that we get new information fromour friends at the American Medical Association orAmerican College of Cardiology about the pending paycuts for Medicare providers. If that is not enough, it seems ona monthly basis there are new attacks in the media or throughmedical journals regarding overutilization of percutaneouscoronary intervention (PCI) [1–8].

The few of us out there who have been performingPCI now for over 30 years sometimes find it hard not tolook at these articles and laugh. Of course, electiveangioplasty is all about quality of life and relief of angina.It has nothing to do with reducing mortality or evenimproving left ventricular function. We have shown thatPCI in patients who present with acute coronary syndromecan result in a reduction in mortality. As one of the firstto report reduction in mortality in patients with cardio-genic shock, I know that PCI in these patients is thestandard of care [9].

In the 1970s, 1980s, and 1990s, we saw a revolution ininterventional cardiology. The revolution was brought on bypioneers in the field who were working in a differentregulatory environment. Dr. Edward Diethrich and I cameupon the idea of perhaps reducing restenosis by placingpolytetrafluoroethylene (PTFE) covered stents in the cor-onary arteries [10].

As soon as reports came out, a number of interventionalgods, such as Antonio Colombo and Steve Ellis, were askingme when we would have a commercially available device.After our report, it only took 3 or 4 years before severalmanufacturers had commercially available PTFE coveredstents that have been primarily utilized as emergencytreatment. Now they are an integral part of everycatheterization laboratory that does interventional therapy.In 1993, with the help of engineers at Boston Scientific, ourgroup developed the first hydrophilic coronary wire [11]. Ittook just a few years before wires of this type becamecommercially available and are probably used in about 10%of angioplasties performed in the United States. These wiresare also frequently used in chronic total occlusion (CTO)procedures, but more on that later.

In the early 1990s, working with a Japanese engineer, wedeveloped the first radiofrequency wire. Within 5 or 6 years,

1553-8389/11/$ – see front matter © 2011 Elsevier Inc. All rights reserved.doi:10.1016/j.carrev.2011.08.002

radiofrequency wires became commercially available witha sophisticated imaging system [12,13].

As an inventor, it seems over the last 4 or 5 years thatthings have ground to a halt in the United States. In the past,one could present technology such as these mentioned andwithin a very short period of time an agreement has occurredand the companies begin making prototypes for you. Now itappears one must spend a substantial amount of money to getthrough the approval process before sales can occur. Werecently successfully did this with a snare device that wedeveloped both for large vessels and for CTOs [14].

There certainly is a need for innovation in interventionalcardiology today. Drug-eluting balloons and resorbablestents are being utilized in various applications; however,from a regulatory standpoint, the question is how long isthis going to take for their approval to take place in theUnited States. We are clearly lagging behind our Europeancolleagues as well as the rest of the world with ourregulatory process.

Percutaneous valves are here, but again mainly utilizedoutside the United States. However, from an innovationstandpoint there are opportunities, since the vascularcomplications are still too high and embolic phenomenonoccur frequently, which is why a number of us have beenworking on various embolic protection and vascularimprovements [15].

Clearly, there are opportunities for improvement intechnology, but one thing has to be clear: you need toshow that whatever device you develop it must be costeffective. The days of expensive technology for technologysake are over.

In terms of innovation, the so-called final frontier ofinterventional cardiology is CTO PCI. This population,which is the single reason most patients undergo bypasstoday, introduces great opportunities for innovation. This iswhat prompted us to develop new wires and supportcatheters over the years [16]. This is one of the reasonswhy we are excited at Cardiovascular Research Technolo-gies (CRT) to put together a CTO group in the United Statesworking with European and Japanese colleagues. We arelooking forward to resurrecting the CTO Club at CRT inMarch of 2012. Stay tuned.

272 Guest Editorial / Cardiovascular Revascularization Medicine 12 (2011) 271–272

Innovation in CTO I think will continue in the future, andI think it has potential to bare fruit. On the other hand, anynew device needs to be cost effective and make theprocedure easier, safer, and/or quicker.

When one thinks about innovation, are you born aninnovator or can it be developed? The Biodesign Group atStanford has put together a program for fellows, bothengineers and physicians, to learn the process. The process isnot as simple as one thinks. Sometimes the nonscientist, butthe great observer, can make a contribution that is notseen by the interventionist for he/she cannot see the forestthrough the trees. We think that programs such as the one atStanford are one way to teach people to be innovators. Weare so excited about this that we are starting a similarprogram, Phoenix Medical Device Innovation Fellowship,which we hope to start next year. Through groups like thegroups at Stanford, as well as through our program, we thinkinnovation can occur in the 21st century not only ininterventional cardiology, but also in other aspects ofmedicine. However, this is a different regulatory environ-ment than in the past. Patient safety is paramount and it isalso going to take more time and more expense and moreknow-how to be able to move even a blockbuster medicaldevice forward.

Richard Heuser, FACC, FACP, FESC, FSCAIE-mail address: RHeuser@iasishealthcare.com

References

[1] Chan P, Patel M, Klein L, Krone R, Dehmer G, et al. Appropriate-ness of percutaneous coronary intervention. JAMA 2011;306(1):52–61.

[2] Cadet J. AHA adjusts angioplasty stats to lower annual figure.Cardiovascular business Web site. http://www.cardiovascularbusiness.com/index.php?option=com_articles&articles=25634&publicaction=22&view=portals. December 19, 2010. Accessed January 20, 2011.

[3] Mahoney EM, Wang K, Arnold SV, et al. Cost-effectiveness ofprasugrel versus clopidogrel in patients with acute coronary syndromesand planned percutaneous coronary intervention: results from the trialto assess improvement in therapeutic outcomes by optimizing plateletinhibition with prasugrel—Thrombolysis in Myocardial InfarctionTRITON-TIMI 38. Circulation 2010;121(1):71–9.

[4] Boden WE, O'Rourke RA, Teo KK, et al. COURAGE Trial ResearchGroup. Optimal medical therapy with or without PCI for stablecoronary disease. N Engl J Med 2007;356(15):1503–16.

[5] Hilborne LH, Leape LL, Bernstein SJ, et al. The appropriateness ofuse of percutaneous transluminal coronary angioplasty in New YorkState. JAMA 1993;269(60):761–5.

[6] Yim J, Khang YH, Oh BH, Kim YI, Kim CY. The appropriateness ofpercutaneous transluminal coronary angioplasty in Korea. Int J Cardiol2004;95(2-3):199–205.

[7] Hemingway H, Crook AM, Dawson JR, et al. Rattling theappropriateness of coronary angiography, coronary angioplasty andcoronary artery bypass grafting: the ACRE study. J Public Health Med1999;21(4):421–9.

[8] Patel MR, Dehmer GJ, Hirshfield JW, Smith PK, Spertus JA.American College of Cardiology Foundation Appropriateness CriteriaTask Force; Society for Cardiovascular Angiography and Interven-tions; Society of Thoracic Surgeons; American Association forThoracic Surgery; American Heart Association, and the AmericanSociety of Nuclear cardiology Endorsed by the American Society ofEchocardiography; Heart Failure Society of America; Society ofComputed Tomography. ACCF/SCAI/STS/AATS/AHA/ASNC. 2009Appropriateness Criteria for Coronary Revascularization: a report bythe American College of Cardiology Foundation AppropriatenessCriteria Task Force, Society for Cardiovascular Angiography andInterventions; Society of Thoracic Surgeons; American Association forThoracic Surgery; American Heart Association, and the AmericanSociety of Nuclear cardiology Endorsed by the American Society ofEchocardiography; Heart Failure Society of America; Society ofComputed Tomography. J Am Cardiol 2009;53(6):530–53.

[9] Heuser RR. Cardiogenic shock treated by PTCA. Cardiology 1987;4:64–6.

[10] Heuser RR, Woodfield SL, Lopez AN. Obliteration of a coronaryartery aneurysm with a PTFE-covered stent: endoluminal graft forcoronary disease revisited. Catheter Cardiovasc Interv 1999;46:113–6.

[11] Heuser RR. The use of a new wire in a ten-year-old coronary arteryocclusion: The Jagwire Recanalization Guidewire. Cathet CardiovascDiagn 1993;29:173–6.

[12] Cordero H, Warburton KD, Underwood PL, Heuser RR. Initialexperience and safety in the treatment of chronic total occlusions withfiberoptic guidance technology: optical coherent reflectometry.Catheter Cardiovasc Interv 2001;54:180–7.

[13] Baim DS, Baden G, Heuser RR, Opoma JJ, Cutlip DE, Massaro JM,Marulkar S, Arvay LJ, Kuntz RE. Utility of the safe-cross-guidedradiofrequency total occlusion crossing system in chronic coronarytotal occlusions (Results from the Guided Radio Frequency EnergyAblation of Total Occlusions Registry Study). Am J Cardiol 2004;94:853–8.

[14] Small diameter snare; Patent granted April 29, 2003; Number:6,554,842.

[15] Catheter introducer system patent granted January 23, 2007; number 7,166,088. Embolism prevention device; patent granted April 2, 2002;number: 6,364,900.

[16] Catheter guidewire system using concentric wires; patent grantedJuly 22, 2008; number 7,402,141. Catheter introducer system patentgranted on March 29, 2011; number 7,914,492B2.