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Ann Thorac Surg 2000;70:1774-1778
© 2000 The Society of Thoracic Surgeons

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Supplement: outcomes 2000

Pro: beating-heart surgery for coronary revascularization: is it the most important development since the introduction of the heart-lung machine?

^a Cardiopulmonary Research Science Technology Institute, Dallas, Texas, USA

Address reprint requests to Dr Mack, COR Specialty Associates of North Texas, P.A., 7777 Forest Lane, Suite A-323, Dallas, TX 76230
e-mail: mmack{at}cristi.org

Presented at Outcomes 2000, "The Key West Meeting," Key West, FL, May 24–28, 2000.

It is an honor and a privilege to share the podium with Dr Cooley. Since my years in college in the late 1960s, he has served as a role model and an icon for me and I am humbled by the task of debating him on the merits of a procedure that he pioneered. Nonetheless, I will attempt to make the case that beating-heart surgery is a significant incremental improvement in the performance of coronary artery bypass surgery.

I will concede the debate to Dr Cooley that beating heart surgery is not the most significant advance in coronary revascularization since the heart lung machine! First, it should be noted that beating-heart surgery historically preceded cardiopulmonary bypass (CPB), making CPB the most important advance since beating-heart surgical revascularization [1, 2]! Second, if in fact we evaluate post-CPB, the significance of "new era" minimally invasive (MICS) beating-heart surgery for sake of debate, it ranks only third in my opinion! The introduction of catheter-based therapy by Greuntzig in 1979 and the broader use of arterial grafts as the preferred conduit have had a greater impact on coronary revascularization than beating-heart surgery has yet to date.

Catheter-based coronary revascularization

Catheter-based interventions were introduced in 1979. Within 10 years, due to significant incremental improvements of the original core technology and technique of balloon angioplasty, annual procedural volume eclipsed that of coronary bypass surgery in the United States. Further technological enhancements including low-profile, steerable catheters, stents, closure devices, and pharmacologic adjuncts have minimized procedural morbidity and expanded the applicability so that currently annual case volumes of angioplasty outnumber surgery by a 2:1 ratio and in many centers by 4:1.

Arterial grafting in coronary artery bypass surgery

With regard to arterial grafting, it has been clearly demonstrated by Loop that "use of the left internal thoracic artery is the single most important determinant of survival and event-free survival" [3]. It has further been shown by Lytle that bilateral internal thoracic artery grafting further prolongs survival [4]. Yet in 1997, despite this evidence, only 76% of all coronary operations in the US utilized an arterial graft and only 73% of first operations [5]. Seventy percent of all grafts placed were vein grafts despite this clear evidence. In fact, more than 250,000 catheter-based procedures per year are procedures performed to reopen occluded saphenous vein grafts, thereby not only negatively impacting overall long-term surgical results, but "giving away" intervention to cardiologists.

Beating-heart surgery

There are of course no new ideas, only ideas before their time, now resurfacing to see the light of day. Of course, the original surgical bypass of coronary vessels was performed on a beating heart only without the variety of innovative techniques and enabling instruments to make the procedure easier and with better technical outcomes. CPB provided a significant discontinuous improvement, by allowing surgeons to operate in a bloodless and quiet environment as well as protecting the heart from potential procedure-induced ischemia. This allowed intracardiac surgical procedures to be performed that would still not be possible without CPB. CPB was so successful in achieving these goals, it became adapted universally for all cardiac surgery, rendering a beating-heart approach moot, at least until Gruentzig’s percutaneous transluminal coronary angioplasty (PTCA) came along to introduce a less invasive approach to coronary revascularization. The rapid acceleration of catheter-based procedures along with closer scrutiny of morbidity associated with CPB, especially with respect to neurocognitive outcomes, led to the resurgence of interest in the original beating-heart techniques. Only now, beating-heart bypass facilitated by new technology and techniques demonstrates the superfluous nature of the heart-lung machine to bypass a structure in an epicardial location.

Innovation

Toby Cosgrove said in his recent presidential address at the American Association of Thoracic Surgery, "What we fear most is change" [6]. It took 30 years for cardiac surgeons to embrace change of such significance as MICS. The future of cardiac surgery critically depends on our ability to improve our adaptation rate to change and innovation. It is instructive, therefore, to examine how and why change occurs.

The drivers of change include: a desire to solve an unmet need; a desire to improve quality outcomes; a desire to broaden applicability; a desire to improve user-friendliness; competition (the threat of obsolescence); applicability of new technology to old ideas; and economic incentives (opportunity for profit and need to improve resource-driven outcomes).

All of these factors except for "solving an unmet need" are drivers of innovation that have played a role in catalyzing the renewed interest in beating-heart surgery and MICS in general.

Significant change occurs first by a discontinuous innovation ie, a quantum difference from the continuity that preceded it. However, the value of this discontinuous innovation or breakthrough is only determined by the incremental improvements that follow. Numerous examples of this exist in the introduction of new technology including portable telecommunications, computers, airplanes, and more recently, catheter-based coronary revascularization. The interventional cardiologists demonstrate intimate and profound understanding of this concept. The addition of low-profile, steerable catheters, exchange devices, stents, and adjunctive pharmacologic agents have incrementally improved Greuntzig’s original balloon catheter and created the value of this therapy by broadening applicability, increasing user-friendliness, and minimizing procedural morbidity. They have doubled their procedure rates in only a few years and dramatically improved their own game. Enough value has been created by incremental improvements that results now approach CABG surgery. There are nine randomized trials comparing PTCA versus CABG and a meta-analysis by Pocock [7] and all show the same results, ie, procedural mortality and morbidity are the same with the only difference being the need for repeat revascularization. In the most current study, the ARTS trial, the only difference between PTCA and CABG is the need for repeat revascularization at 1 year. That difference is now only 14% (73% vs 87% 1-year freedom from revascularization) [8]. As a surgeon, one cannot help but notice the statements made by interventional cardiologists such as Patrick Serruys, who predict that there will be no need for cardiac surgery after 2004!

Value

In cardiac surgery, the predominant drive is to increase value, which is the ratio of benefit as measured by longevity divided by cost as defined by procedural mortality and morbidity. Risk-adjusted operative mortality for coronary artery bypass has not changed between 1990 and 1997, and showed only a slight decrease in 1998 [5]. Significant morbidity including stroke, renal failure, and respiratory complications has shown no improvement throughout the 1990s.

The way to increase value is to improve long-term survival by the greater use of arterial conduits to increase longevity or to decrease procedural mortality/morbidity by less invasive surgical techniques such as beating-heart surgery or preferably by doing both. Despite the proven survival benefit of left internal thoracic artery grafting to the left anterior descending coronary artery (LAD) and the added survival benefit of bilateral internal thoracic artery use, the saphenous vein graft still is the conduit used 70% of the time. Evidence is also accumulating rapidly that beating-heart surgery lowers mortality and morbidity, yet is employed only 18% to 20% of the time.

Outcomes of beating-heart surgery

So if beating heart surgery is really an incremental improvement to conventional CAB, what is the evidence, first, that long-term outcomes are not sacrificed under the mantra of less invasiveness and, second, what is the evidence that there is a value-added to beating-heart surgery by decreasing procedural mortality and morbidity?

There are five published series of early angiographic results of left internal mammary artery (LIMA) to LAD grafting performed on a beating heart through a left anterior thoracotomy. We summarized these in a review in 1998 [9]. All series showed that early graft patency in minimally invasive direct coronary artery bypass (MIDCAB) was comparable with arrested-heart conventional bypass surgery with patency rates in the mid to high 90% range. More recently, the results of the POEM study have been presented [10]. This was an 11-center comparative study between MIDCAB and conventional CAB where the primary end-point was 6-month angiographic patency. One hundred twenty patients have now been studied at 6 months, with the LIMA patency rate in 32 conventional CAB patients being 97% and in 88 MIDCAB patients being 96%.

Currently, there are published results of angiographic graft patency in four series of OPCAB procedures [11–15]. Those are summarized in Table 1. All show graft patency to also be in the mid to high 90% range with LIMA graft patency being 100% in some series. Although experience with beating-heart surgery is relatively limited compared with arrested-heart CAB, and although no randomized series exists, I believe that concerns regarding compromise of the operation by beating-heart techniques have been answered and allayed!

• Beating heart surgery has the potential to allow the 80% (5 billion people) who now have no access to bypass surgery to be treated. Just in the last 6 months, several cardiac surgery groups, including Eric Jansen from Utrecht, have introduced beating-heart surgery to under-resourced, low-tech regions such as Murmansk, Tomsk, and Gorki City in the former Soviet Union. • Why use the pump if one can accomplish the same thing without it? • Beating-heart surgery is an incremental step to even less invasive surgery. • There is no compromise of early graft patency compared with arrested heart surgery. I believe the data presented above demonstrate equivalence. • Beating-heart surgery takes less time once experienced • Costs of beating-heart surgery are approximately 20% less than arrested-heart surgery • There are improved neurocognitive outcomes compared with conventional CAB. • There is proven mortality benefit in high-risk subgroups including the elderly. • There is a trend to an overall mortality benefit with beating-heart surgery that will be borne out with more experience, larger series, and randomization. • There is clear evidence, presently, of less blood loss, fewer transfusions, less inotrope, and IABP use in beating-heart compared with conventional CABG.

What is the status of beating-heart surgery in May 2000? There has now been enough experience and evidence to know that beating-heart surgery is safe and effective. Current estimates are that 18% to 20% of the coronary bypass operations performed in the US are off-pump. It is technically possible with current stabilizers and exposure techniques to perform virtually all coronary surgery off-pump. Some centers have reported that the pump has not been used for any coronary surgery and that there has been no need for conversion to the pump in 1999 and 2000 to date (J Hart, personal communication). There are at least 35 articles that show some benefit to beating-heart surgery. Most show a benefit compared with STS historical data, some compared with a concurrent or computer-matched on-pump group, and there are a few, small randomized studies.

What are the demonstrated advantages that there is enough evidence published that we can state with some degree of certainty? Many series have shown that there is less blood loss (n = 10), fewer blood transfusions (n = 10), less inotrope, and less intraaortic balloon use (n = 4) in beating-heart surgery compared with conventional CAB. Nonrandomized but substantial data also exist indicating equivalent graft patency (n = 5), shorter hospital length of stay by about 1 day (n = 4), and a mortality benefit in high-risk subgroups including the elderly (n = 3), women (n = 1), reoperations (n = 1), and patients with significant comorbidities. Eight series have concluded that beating-heart surgery is "safe and effective." Seven series demonstrate equivalency or better compared with on-pump in their initial experience. Decreased inflammatory response is shown in two articles and benefit in "high-risk" patients [4], after acute myocardial infarction [1], in LMCA disease [1], and ability to perform with multiple arterial grafts on a beating heart.

Although there has not yet been unequivocal evidence of an overall mortality benefit, there is a trend in that direction. In review of our results in our practice in Dallas of 8,941 patients undergoing CABG, the use of CPB was an independent risk factor for mortality by multivariate logistic regression analysis with an odds ratio of 3.2:1, with only reoperation being a higher predictor of mortality. Furthermore, analysis of our most recent results of 2,031 CAB operations performed in 1999, of which 30% were performed off-pump, showed an overall operative mortality of 2.96%. The mortality in the off-pump groups was 1.82% (predicted mortality 3.29%). This compared with an on-pump mortality of 3.44% (predicted risk 2.82%). Despite selection of an overall higher risk group of patients to off-pump CABG (higher predicted risk), the observed mortality was markedly lower.

Results from Hart in Harrisburg indicate in the last 331 CAB operations with no selection bias, all performed with the Octopus stabilizer, there was an observed mortality of 0.3%, with a predicted mortality of 2.22% (p < 0.025) (J Hart, personal communication). Furthermore, analysis of charge data shows a 25% decrement in charges of OPCAB compared with on-pump surgery. Data from Puskas also demonstrate a reduction in cost of 22.6% with OPCAB surgery [11].

Neurological outcomes of cardiac surgery

One of the greatest deterrents to the use of CPB relates to the potential for adverse neurological and neurocognitive outcomes. In the widely quoted series by Roach, 6.1% of 2,108 patients undergoing elective CABG on-pump suffered a detectable postoperative neurological deficit, one half a focal defect and one half diffuse [16]. Advanced age and prolonged CPB were the strongest factors predictive of adverse neurological outcomes. Additional studies have demonstrated diminution in cognitive performance in up to 85% of patients undergoing CABG with CPB, many of which persist long term [17].

Although there are many other factors besides the pump that can contribute to adverse neurological outcomes, including general anesthetic agents, manipulation of the aorta, and postoperative atrial fibrillation, use of the pump has multiple causative factors that may contribute to neurologic insult. These include systemic inflammatory response, cerebral hypoperfusion, SCADs from shed mediastinal blood, atheromatous debris from cannulation and flow shear, platelet aggregates, chylomicrons, air bubbles, glove powder, tube fragments, silicon antifoam material, and red blood cell fragment phospholipids [18]. Elimination of CPB has the potential for diminishing the neurologic insult due to these factors. Recognition of CPB as origin to a multiplicity of problems fixable by more incremental innovations has spawned a plethora of new instruments, further enabling improvements in cardiac surgery.

What evidence currently exists that this in fact may be true? There are eight published series comparing neurological and neurocognitive outcomes of on-pump and off-pump surgery (Table 2) [17, 19–25]. Two are randomized and the other six are comparative. Interpretation of results between various series is problematic due to a number of issues including study design and endpoints used. Variability of neurologic outcomes is also dependent on the amount of aortic cross-clamping used, neurologic assessment tools employed, the age of the study groups, and type of statistical analysis (group mean vs incidence) to analyze results. In addition, a common endpoint that has been used as an indicator of brain injury, S100B protein, has recently been demonstrated to be invalid due to the contribution of shed mediastinal blood to the levels [26]. The study of Diegeler and associates from Leipzig is worthy of mention. In this study, 40 patients were randomized to on- or off-pump. Transcutaneous Doppler HITS (high intensive transient signals) averaged 394 on-pump versus 11 off-pump (p < 0.0001) Neurocognitive impairment on testing was detected in 90% of the on-pump cases and none of the off-pump group.

We are in a time of change in cardiac surgery and we can choose to change and adapt or we can follow the road to obsolescence of tuberculosis surgery and surgery for rheumatic heart disease and arrythmias. The future is bright with technologic possibilities never dreamt of just a few years ago, and beating-heart surgery is just the beginning. In his book, Crossing the Chasm, Geoffrey Moore described the route by which technology is introduced [27]. The first users are the innovators, followed by the early adapters. If technology is going to be successfully introduced, it must then "cross the chasm" to the early majority. It is subsequently adopted by the late majority and finally the laggards. Beating-heart surgery has successfully "crossed the chasm" and is now in the early majority phase. But there is a myriad of technological achievements at the innovator stage. From the recent introduction of robotics and computer assistance, to anastomotic facilitators, micropump assist devices, heart failure devices, and minimally invasive atrial fibrillation treatments, the future can be a bright one. The recent performance of a totally percutaneous catheter-delivered aortocoronary bypass with saphenous vein, is indicative of the possibilities at the fingertips of those who innovate.

Again to quote Cosgrove, "It is not the strongest of a species that survives ... but the one most adaptive to change," Charles Darwin. "We are the victims of our own success ... creative thinking is not one of our strengths. We have a bias against innovation" [6].

While I concede to Dr Cooley that although beating-heart coronary bypass surgery in and of itself has not made the same impact that CPB did through its introduction, the momentum for "less invasiveness" can certainly be declared a significant improvement on a theme. And that continuous innovation and incremental improvements can be as important if not more than a discontinuous innovation such as CPB.

I caution that our work towards continuous improvement is not over. While outcomes have reached an all-time high score, other drivers for innovation such as competition and obsolescence should be considered when resistance to change is tempting.

In closing, I am reminded of the remarks made by Dr Cooley in his presidential address to the Society of Thoracic Surgeons in 1994 [28]: "Early in my career, I had adopted a three word motto-modify, simplify, and apply." Isn’t that what we are doing with beating heart surgery, taking the enormous achievements of Dr Cooley and the other pioneers and modifying, simplifying, and applying?

To further quote Dr Cooley in 1994, "We must not become mediocre through overstandardization. We should try to recapture the spirit of challenge and discovery ... we must think independently and question the validity of so-called truths or time honored treatment methods, so that we maintain our specialty’s reputation for progress."

Denton, I could not have said it better!

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