Fly Boys, Fusion Artists or Cool Guys: Testing the Boundaries of Imagination.
Introductory note: A few months ago, a Chinese research team submitted a manuscript detailing its pioneer work of combining many diagnostic and interventional procedures to the Journal of Geriatric Cardiology. The combined procedures included (1) coronary angiogram, coronary angioplasty and stenting (PCI) and pacemaker implantation, (2) PCI and catheter ablation for supraventricular tachycardia, (3) PCI and alcohol septal ablation for hypertrophic cardiomyopathy (HCM), (4) PCI plus carotid angioplasty and stenting, etc. The paper was reviewed and criticized ferociously by the Chinese peer-reviewers so the editor-in-chief sent me the paper and asked me to write an editorial from the US perspective. As a young Confucianist scholar who practices martial art by staying late and reading the Kiem Hiep stories of Kim Dung, I followed the foot step of Mao Ton Cuong and wrote this editorial to the ipod generation.
Thach Nguyen MD FACC FACP FSCAI
In the early years of coronary intervention, when a single lesion was found, the question was then asked whether it was feasible and safe to immediately dilate the lesion with plain old balloon angioplasty (ad hoc POBA), or to call in a senior interventional cardiologist to do POBA on a later date. If lesions were found in more than one coronary artery location, then the interventional cardiologist would pull his or her hair and ask whether it was feasible and safe to dilate the other lesion(s) at the same session. Now 20 years later, with nearly perfect outcomes due to stent availability and high level of operator experience, the question of multiple coronary stenting in one session is neither problematic nor relevant. However, if not all lesions are taken care of immediately or in near future sessions, the question would now be whether the patient receives standard of care, as there is no complete revascularization.
During any intervention, on the way to the coronary system, an obstructive lesion could be found incidentally in the iliac artery (from the femoral approach), or in the subclavian artery (from the radial approach); one would ask whether there is indication to intervene before or after the coronary intervention (PCI). In these situations, the purpose of the peripheral intervention is not only to save time, contrast, discomfort, and money, it is a question of procedural success and access for equipment, especially if prolonged indwelling of an intra-aortic balloon pump is needed.
During an elective or emergent PCI, if the manipulation of various hardware across different vascular territories was smooth, without any minor hint of obstruction, then the peripheral vascular system is assumed to be without abnormality. Then as it was told or whispered that not in rare occasions, a proud (or arrogant) interventional cardiologist came and reported a perfect outcome of PCI to the family and referring physician. However, a few months later, the patient died from a lung tumor or from a ruptured aortic aneurysm (AAA), which was not discovered during the elective hospitalization for PCI. Did the interventional cardiologist miss the lung tumor while taking the history and doing the physical examination of the patient? Did the interventional cardiologist miss the AAA when manipulating the catheter across the abdominal aorta?
In this issue of the Journal of Geriatric Cardiology, C.Y. Lu et al. reported their experience of systematic combined percutaneous diagnostic procedures and interventions in elderly patients. I presume that all coronary lesions were taken care of in either one or staged sessions. There are 3 questions about this concept of combined procedures.
The first hot (or sexy) question is whether patients have complete revascularization even when the authors performed all the vascular interventions. As a scientist, the answer is NEVER. As a clinician, the answer is YES. Why is there a contradiction? The interventional cardiologists can stent all significant lesions in all vascular beds. This is considered a complete job (or revascularization). A scientist with an intravascular ultrasound can prove that all arteries are still full with plaques which can rupture and cause occlusion (including myocardial infarction) at any time. This is eternally incomplete revascularization. As a manipulative statistician who considers success if there is a difference of 1% of data in a period of 1 day, 7 days, one month, one year or maximally 5 years ( as in all randomized cardiovascular trials), then I believe interventional cardiologists did do a good job as judged by human criteria (and errors).
The second question for the authors is concerning their manual dexterity and our frequently bragged-about ability. All patients had PCI combined with interventions in another vascular bed (renal, carotid or lower peripheral vasculature), PCI with alcohol septal ablation, or PCI with electrophysiologic study (EP) and interventions (including pacemaker insertion). The follow-up showed perfect results with no mortality and no major adverse events. Was the success due to individual skill of the operators or perfect strategic planning? Can an average interventional cardiologist duplicate the same results?
Any interventional technique or strategy can only become popular, and stock of the manufacturing company can only soar if the technique can be applied daily by the average interventional cardiologist. I never doubted the genius (and hard work) of the inventor of the percutaneous aortic valve. However, the procedure will never take off and fly high unless an average Doe interventional cardiologist from the Midwest, South America, Asia, or Eastern Europe can enjoy and play with his or her toy every day with success. Until then, the manufacturing company could apply orphan status for its devices with the Food and Drug Administration. The same question is why many esteemed interventional radiologist friends cannot do the PCI or combined procedures as the authors did? The answer lies in the level of clinical competence. Technically, interventional radiologists can manipulate any catheter, wire, stent, device, as best (or better than) anybody else; however, PCI requires online clinical judgment as the patient is (or should) never be off-line during the procedure unless after a successful PCI prior to transfer or after a failed dramatic Code Blue. One minor note from the US point of view: No interventional cardiologists on this side of the Pacific are competent with both PCI and EP studies or interventions. It is a question of either and not both. So the Chinese data could not be duplicated here if they wish to randomize both coronary and EP patients.
The third question is whether it is beneficial to do combined procedures. Financially, it is. A patient who separately has an angiogram, a PCI, an EP study, or pacemaker insertion occupies on separate occasions a hospital bed for x number of hours. Now with combined procedures, all bundled on the same bed within the same period of time, the money generated by that bed is double or triple. US payment is based on the DRG system, so separate procedures bring more monies then combined procedures. This is why Medicare (the largest insurance system for the elderly by the US government) promotes bundling of procedures while it prosecutes unbundling of charges.
As physicians, what should we do? By combining procedures, we save monies for patients (who pay us and the hospital through insurance), and then use cost-effectively the health care dollars which all come from taxes (including mine and yours). By combining procedures, we minimize the discomfort to the patient with less manipulation. However, all the decisions need to be clinically centered. Did the patient have indications or was the procedure done because of our innate oculo-stenotic reflex? Was the lesion incidentally discovered because we are fly boys on auto-pilot passing by? Are we pioneers running ahead of the pack, always edging for something sexy or exciting? Do we love raising the bar higher or testing or pushing further the boundaries of religious, political, social, emotional, technical or interventional limit? Knowing the American mentality, the answer to the last question is all of the above. I believe combined procedure is here to stay and will be the norm of the future.
Nguyễn Ngọc Thạch