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eRounds _ Fall 2011

Breakthrough: Transcather Aortic Valve Replacement

Cleveland Clinic interventional cardiologists E. Murat Tuzcu, MD, and Samir Kapadia, MD, and cardiothoracic surgeon Lars Svensson, MD, have taken a leadership role in developing and testing this technology through the Placement of Aortic Transcatheter Valves (PARTNER) trial. Results of the first arm, PARTNER B, were released in September 2010 and secured TAVR as an effective treatment for patients deemed inoperable due to comorbidities. In June 2011, PARTNER A results were released, which compared TAVR to surgery in high-risk patients. Dr. Tuzcu, Cardiovascular Medicine Department Vice-Chairman, provides an update:

How did TAVR fare in high-risk patients?

PARTNER’s second arm showed TAVR wasn’t inferior to aortic valve replacement surgery in terms of survival and stroke-free survival among patients whose predicted risk of mortality with standard open heart surgery for aortic valve replacement was quite high. That makes TAVR an acceptable alternative to surgery in very high-risk patients. It doesn’t mean all patients should have TAVR.

Is the risk of stroke with TAVR a concern?

Risk of any serious complication is concerning, but the risks must be put in perspective. In the PARTNER A trial, the major stroke risk was numerically higher with TAVR, whereas the risk of dying was lower. However, neither difference was statistically significant. Moreover, when we look at the combined endpoint of risk of death or major stroke, there was no difference.

How is evaluation of TAVR proceeding?

Major vascular complications were high in patients who underwent transapical TAVR, primarily due to the large catheters required. Edwards Life science has since developed a newer valve with a smaller delivery catheter. The PARTNER IIB trial is now comparing the new valve and delivery system with the already-tested TAVR system in inoperable patients. In this trial, there is no randomization to medical therapy.

PARTNER IIA is being planned to test the new valve and delivery system in moderately high-risk patients who are candidates for surgical AVR.

When do you see TAVR being used in normal-risk patients?

We must meticulously investigate this technique, testing it in different risk groups. Right now our focus is on higher-risk patients. Using TAVR in normal-risk patients would require demonstrating that it’s as good as surgery, which is a safe, effective and, most importantly, durable therapy for these patients. It will require a lot of work before we can say that TAVR is as good in such a patient.

What is Cleveland Clinic's opinion of TAVR today?

TAVR is an exciting technology that is part of a comprehensive service for patients with high-risk aortic valve disease and complex comorbidities. It’s one of several options for patients at high risk for surgery, including optimization of clinical status before treatment and ICU management.

Dr. Kapadia can be reached at 216.444.6735, Dr. Tuzcu can be reached at 216.444.8130 and Dr. Svensson can be reached at 216.445.4813.

New Service: Endocrine Calcium Clinic

The clinic, based in the Department of Diabetes, Endocrinology and Metabolism, will benefit patients with:

  • Common problems such as hypocalcemia, Vitamin D deficiency, hyperparathyroidism, osteopenia, primary osteoporosis, renal stones and abnormal DXA results
  • Bone disorders such as Paget’s disease, secondary osteoporosis and other rare diseases
  • Complex underlying problems that increase the risk of metabolic abnormalities, such as inflammatory bowel disease, cancer and renal failure
  • Metabolic abnormalities that occur after bariatric surgery and organ transplantation

Thorough evaluations include DXA bone density scans performed and interpreted by certified specialists. An on-site laboratory is equipped to test markers of bone turnover, mineral and nutrient deficiencies as well as hormonal abnormalities. An infusion center allows patients to receive injections or infusions of up-to-date therapies such as zoledronic acid (Reclast®) and denosumab (Prolia®). The Calcium Clinic is staffed by a wide range of physicians in several disciplines, providing patients with the most advanced care possible.

Staffing the clinic are three endocrinologists, Consultant Director Angelo A. Licata MD, PhD, FACP, FACE, Krupa Doshi, MD, CCD, and Leila Khan, MD, CCD, and internist Susan E. Williams, MS, MD, CCD, FACN, FACP, an expert on nutrition and bariatric bone disease.

The specialists in the Calcium Clinic can be reached at 216.444.6568.

Study: Kidney Cancer Treatment Promising

The global, randomized, Phase III trial of axitnib versus sorafenib as a second-line therapy for mRCC, led by Brian Rini, MD, found that axitinib was superior to sorafenib in the primary endpoint of median progression-free survival (PFS). Axitinib was also superior when considering patient-reported quality of life measures.

This Phase III trial, also called AXIS 1032, was an international study involving 723 patients with clear-cell advanced kidney cancer who had disease progression on one prior standard regimen (cytokines, sunitinib, bevacizumab or temsirolimus). Patients were randomized to receive axitinib 5 mg twice daily or sorafenib 400 mg twice daily. Patient questionnaires (Functional Assessment of Cancer Therapy-Kidney Cancer Symptom Index [FKSI-15]) and its disease-related symptoms subscale [FKSI-DRS] were administered at several points during the study.

The results showed a median PFS of 6.7 months with axitinib compared to 4.7 months for sorafenib, with benefit maintained in all patient subgroups. Complete or partial response to treatment more than doubled in patients treated with axitinib (19 percent versus nine percent) compared to sorafenib.

This was the first trial to compare targeted therapies against each other in kidney cancer patients. All prior phase III studies of targeted drugs compared their effectiveness against either placebo or cytokines. Given that axitinib is biochemically more potent against the VEGF receptor, this trial supports that biochemical potency translates into clinical efficacy in this setting.

A Phase III trial has also accrued of front-line trial axitinib vs sorafenib with results expected in the next one to two years.

To refer a kidney cancer patient to Taussig, call 216.444.HOPE (4673) or 866.223.8100.

Primary Stroke Center Recertified

The advanced use of information technology to track and drive improvement in stroke care, as well as telemedicine services to support rapid stroke treatment, were also acknowledged by the surveyor as areas that made an impression.

“The Joint Commission recertifying Cleveland Clinic as a Primary Stroke Center validates our commitment and efforts to providing the highest-quality stroke care to our patients,” says M. Shazam Hussain, MD, FRCPC, Director, Primary Stroke Center.

“This recertification is due in large part to the team of experts providing stroke care across Cleveland Clinic’s system,” says Peter Rasmussen, MD, Director, Cerebrovascular Center. “Everyone — from the neurologists, neurosurgeons and interventional neuroradiologists who specialize in stroke care to neuroradiology, rehabilitation, emergency medicine, nursing, critical care transport and laboratory medicine — is dedicated to elevating the level of stroke care at Cleveland Clinic.”

Cleveland Clinic offers six Primary Stroke Centers throughout Northeast Ohio to provide consistent, high-quality stroke care and treatment. In addition to main campus, Euclid, Fairview, Hillcrest, Lakewood and Marymount hospitals are Primary Stroke Centers.

The Joint Commission's Primary Stroke Center certification program was developed in collaboration with the American Stroke Association. The program is based on the Brain Attack Coalition's "Recommendations for the Establishment of Primary Stroke Centers."

Your patients can make an appointment with one of our stroke specialists by calling 866.588.2264.