Sees boundaries melting between imaging, surgery

Alexander Leber, MD, was named director of cardiology for Siemens Healthcare (Erlangen, Germany) in March, with responsibilities for not only the company's traditional offerings for high-end imaging but new areas created when Siemens aggressively entered molecular diagnostics with rapid-fire acquisitions of three companies to vault into the second-place position in that rapidly expanding market.

A renown expert, and even among the pioneers in the field of cardiac computed tomography (CT) and magnetic resonance imaging (MRI) of atherosclerosis and cardiac diseases, Leber brings a powerful experience to Siemens in the development and implementation of new treatment and diagnosis strategies.

For 10 years prior to joining Siemens, Leber was a cardiologist at

University Hospital Grosshadern (Munich, Germany), performing both invasive and noninvasive procedures for high-end patient care.

Co-chair for cardiac CT at the research laboratory of the Medizinische Klinik I at the University of Munich, Leber also served for a year as a research coordinator for cardiac CT and MRI at Mount Sinai Medical Center (New York) with the group led by V. Fuster.

Back in Munich, he organized and served as director for the Cardiac CT-Course at University Hospital Grosshadern and was the head of the cardiac imaging unit and research laboratory at the department of cardiology for the University of Munich.

Leber is the author or co-author of 15 reviewed articles or book chapters in scientific journals or medical textbooks, 36 peer-reviewed articles in scientific journals, and more than 95 peer-reviewed, scientific abstracts. He met with Biomedical Business & Technology during the annual congress of the European Society of Cardiology in Munich in September.

BB&T: Both you and the Cardiology Program are new to Siemens. Can you describe what is different in the approach the company is taking?

Leber: Two years ago Siemens created the cardiology program focus. Previously the company was aligned according to its modalities for MRI, CT, angiography, ultrasound, and so on. Each business unit had its own focus without a cross-business unit interaction.

Today I head a very horizontal unit focused exclusively on cardiology, which is absolutely important for customers. I am a cardiologist and my team is made up only of cardiologists. Now in our sales process we are speaking to customers about solutions across the entire Siemens portfolio, with the advantages of each modality.

If a customer wants a 100% Siemens solution, the portfolio today covers the entire hospital from lab chemistry to imaging to nuclear medicine. We can build a hybrid operating room or cath labs that can feature remotely operated magnetic navigation for electrophysiology.

The only thing we do not have is ECG, that's it. Yet we have formed a partnership with Dr ger Medical (L beck, Germany) for monitoring and ECG, so we can speak with confidence about these products as well.

We also do not have intravenous ultrasound (IVUS). Yet Volcano (San Diego) machines, for example, can be integrated into the Siemens Cath Lab. We have the interfaces to support it and you would not recognize that there is any difference. As for optical coherence tomography (OCT), I cannot strictly say we are not interested, but I am not aware of any developments in this modality at Siemens.

We also have an entire information system that starts with a cardiology information system and link to the hospital system. So Siemens is today able to consult with customers from the bedside care down to the clinical workflow.

BB&T: What is the opportunity that Siemens sees in this market?

Leber: Cardiology sales are a growing area for Siemens. Previously if there had been a focus we might have called it angiography-plus. This narrow perspective is far from true today, where we are speaking about multiple modalities like CT and MRI with specific cardiology applications.

Another important change is that in the past, imaging had been 100% driven by radiology, bought by radiology, and run by radiology, and certainly not by cardiology. But now with the utilization numbers coming out of cardiology, that all is changing. Today there is a need for CT scanner and MRI units that serve only the demand coming out of the cardiology community of a medical center. Think only of the demand for screenings that need imaging for earlier diagnosis.

Today in cardiology we have the hybrid operating room that combines the cath lab with surgery. This is a perfect example of how boundaries are melting.

This is not to say cardiologists are interested in running these departments, but cardiology imaging is clearly emerging as a subspecialty similar to what we have already seen in neurologic imaging, and there is now the suggestion of a need for a "hybrid doctor," if you will, a cardiologist with expertise in radiology. This is seriously being considered.

BB&T: Cardiac imaging not only is moving out of the radiology department, but even out of the hospital. The lightweight portable ultrasound Siemens introduced last year and which was challenged here at ESC with the launch of the Philips CX50, is part of a trend that is driving double-digit sales growth. Where is this trend taking cardiology?

Leber: Ultrasound is now a cardiology-specific domain, no question. The success of the Acuson P10 pocket transducer from Siemens is proof enough. I would not go so far as to say we have seen the end of the stethoscope, which gives a lot of information for very little money. But diagnoses today do require greater precision and especially the evidence on which the cardiologist can base his or her decision for treatment.

MRI is certainly an expensive way to go about this for routine practice, so the introduction of portable ultrasound that moves with the doctor within the hospital or to a patient's bedside becomes a huge advantage. It is not always able to provide the true depth of a fully enabled echocardiography machine, but for consultations it has become essential.

Another very important application of these portable devices in cardiology is in private practice. In Europe we still make house calls, you know. In fact in Germany with the intense competition among the cardiologists it is seen as a value-added service. Also, increasingly patients are being moved to their homes by hospitals where the care continues. So to be able to bring a diagnostic tool to the home becomes not just a nice thing to do, but essential for practice.

To cite the example of the P10 again, this is the most portable and least expensive of ultrasound tools. You can put it in your pocket. Or you can move up to a notebook size with the P50 with a lot of software-driven features where the user in the care setting of a home does not need to be an expert to be able to acquire the information, see that it is within expected parameters and bring the captured data back for the cardiologist to review. Or even transmit it to the cardiologist.

The diagnostic sophistication on portable devices is growing. Siemens machines can image vector velocity, left ventricular segment models, ejection fraction and wall motion deficiencies.

Increasingly these less-than-expert readers with a portable ultrasound are general practitioners, and this can be an essential tool in the primary care setting to be used for screenings for heart disease. These doctors can be trained and may choose to become more expert operators, of course. The mobility creates a lot of opportunities.

BB&T: In your new organization you said you also oversee the new products for cardiology acquired from diverse companies such as the former Dade-Behring, (Diagnostic Products Corp. and Bayer Diagnostics.

Leber: You mean we are not yet No. 1? Perhaps we will need to buy Roche.

On one level, these tests represent a very different business model for Siemens, and one that is a welcome change. Here the customer pays us every month for these tests and that is a very comfortable position. Where in the traditional imaging business we may sell a machine to an institution once every eight or 10 years, here we come into regular contact with them and stay very close to their developments.

These are very important tools for triage diagnosis, for determining whether the patient we are dealing with is suffering ischemia or myocardial infarction, for example. In cath lab diagnostics, there are tests to determine heparin level for anticoagulation management and rapid diagnosis of anti-platelet resistance during procedures.

This is my area as well, and where cardiologists will likely never be the primary customer for our lab equipment offering, the point-of-care systems are vitally important for diagnostics, in the cath lab and for therapies.

We do not like to say we are involved in disease prevention, which was a big part of my focus as a practicing cardiologist, because it is the cardiologist who does prevention or initiates treatment. What we do is provide the tools for early diagnosis with in vitro testing of predispositions, and then help to select the appropriate treatment, which is a kind of secondary prevention. We also have tools that help with follow-up care for coronary artery disease, heart failure and so on.

BB&T: Siemens suddenly is the second-largest player in the in vitro diagnostic space for cardiology. How does this fit with Siemens' traditional approach?

Leber: Siemens Healthcare Diagnostics offers POC biomarker tests important for prognosis, such as high sensitivity C-reactive protein (hsCRP) developed by Dade-Behring, the first to have a cardiac specific claim as an independent marker for risk assessment and risk stratification.

From Bayer Diagnostics, Siemens offers TnI-Ultra, a highly sensitive troponin assay for acute coronary syndromes that plays a crucial role in serial testing. We now need only three hours for serial testing, as opposed to the seven to eight hours needed with previous tests. Beds can fill up quickly in an urgent care center, especially on weekends with big football matches. When an older football fan comes in complaining of chest pains, he will occupy a bed for seven to eight hours before the serial test results confirm that he can be released. If we reduce that time to three hours with the confidence necessary to release the patient, then there is a great benefit to both the patient and the care center.

There is a lot coming from Siemens Diagnostics now on the other side in treatment with stem cell and gene therapies. Hopefully in the future, such therapies may help avoid the dramatic interventions and treatments we see today.

We have a very full pipeline and there are hundreds of potential products, from biomarkers to imaging, including my field of cardiac CT that today lets us look into the arteries in a detailed way and diagnosis conditions earlier.

Yet as exciting as all these developments may be, as a cardiologist I still want to push prevention. I wish I was able to show everyone making poor lifestyle choices, such as smokers, the calcification of their arteries that is possible today very immediately and very personally.