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Archive for August, 2013

MAA – Annual Joint Legislative Meeting

Sunday, August 25th, 2013

August 25, 2013 at the Cobb Galleria. For more information, visit Annual Joint Legislative Meeting.

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Annual Joint Legislative Meeting: MAA, Cobb Medical and Atlanta Area Medical Societies

Sunday, August 25th, 2013

August 25, 2013, Atlanta. For more information, visit Annual Joint Legislative Meeting

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GAFP Summer Committee Conclave and Board Meeting

Saturday, August 24th, 2013

August 24-25, 2013, Athens, Ga. For more information, visit Georgia Association of Family Physicians

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Georgia OBGyn Society Annual Meeting

Thursday, August 22nd, 2013

August 22-25, 2013, Reynolds Plantation. For more information, visit Georgia OBGyn Society

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Emory Eye Center’s Research Contributes to Findings on AMD

Thursday, August 22nd, 2013

Emory Eye Center clinical research contributed to the recent findings of a multi-year National Eye Institute (NEI) study, AREDS2 (Age-Related Eye Disease Study). Results concluded that adding omega-3 fatty acids did not improve a combination of nutritional supplements commonly recommended for treating age-related macular degeneration (AMD), a major cause of vision loss among older Americans. The new information is based on an NEI study from the National Institutes of Health (NIH). The plant-derived antioxidants lutein and zeaxanthin also had no overall effect on AMD when added to the combination; however, they were safer than the related antioxidant beta-carotene, according to the study published online May 5 in the Journal of the American Medical Association.

“Millions of older Americans take nutritional supplements to protect their sight without clear guidance regarding benefit and risk,” said NEI director Paul A. Sieving, MD, PhD. “This study clarifies the role of supplements in helping prevent advanced AMD, an incurable, common, and devastating disease that robs older people of their sight and independence.”

AMD

AMD breaks down cells in the layer of tissue called the retina in the back of the eye that provide sharp central vision, which is necessary for tasks such as reading, driving, and recognizing faces. Advanced AMD can lead to significant vision loss and, in the United States, is the leading cause of blindness. About two million Americans have advanced AMD; another eight million are at risk.

“This is helpful information for our patients with AMD or those at high risk for it,” says Baker Hubbard, Thomas M. Aaberg Professor of Ophthalmology and director, Vitreoretinal Surgery & Diseases, who was principal investigator at Emory. “It is important that they have good information on which to base their dietary supplement intake. This study is the culmination of many years of work and gives us answers to questions about the best way to reduce the risk of vision loss from this common disease.”

First study

AREDS, led by the NEI and concluded in 2001 at Emory and other sites, established that daily high doses of vitamins C and E, beta-carotene, and the minerals zinc and copper—called the “AREDS formulation”—can help slow the progression to advanced AMD. The American Academy of Ophthalmology now recommends use of the AREDS formulation to reduce the risk of advanced AMD.  However, beta-carotene use has been linked to a heightened risk of lung cancer in smokers. And there have been concerns that the high zinc dose in AREDS could cause minor side effects, such as stomach upset, in some people.

Second study: pharmacology

In 2006 the NEI launched AREDS2, a five-year study designed to test whether the original AREDS formulation could be improved by adding omega-3 fatty acids; adding lutein and zeaxanthin; removing beta-carotene; or reducing zinc. The study also examined how different combinations of the supplements performed.

The candidates

More than 4,000 people, ages 50 to 85 years, who were at risk for advanced AMD participated in AREDS2 at 82 clinical sites across the country, including Emory. Eye care professionals assess risk of developing advanced AMD in part by looking for yellow deposits called drusen in the retina. The appearance of small drusen is a normal part of aging, but the presence of larger drusen indicates AMD and a risk of associated vision loss. Over time, the retina begins to break down in areas where large drusen are present during a process called geographic atrophy. AMD can also spur the growth of new blood vessels beneath the retina, which can leak blood and fluid, resulting in sudden vision loss. These two forms of AMD are often referred to as dry AMD and wet AMD respectively.

Those patients with large drusen in both eyes or large drusen in one eye and advanced AMD in the other eye were candidates. Those excluded were patients with ocular disease in either eye, other than AMD (glaucoma, etc.); those with previous retinal or other ocular surgical procedures (except for cataract surgery, YAG capsulotomy, laser or other treatments for advanced AMD); and those with any systemic disease with a limited five-year survival.

The supplements

Omega-3 fatty acids are produced by plants, including algae, and are present in oily fish such as salmon. Lutein and zeaxanthin are carotenoids, a class of plant-derived vitamins that includes beta-carotene; both are present in leafy green vegetables and, when consumed, they accumulate in the retina. Prior studies had suggested that diets high in lutein, zeaxanthin and omega-3 fatty acids protect vision. Before the AREDS2 study finished, manufacturers began marketing supplements based on the study design.

In AREDS2, participants took one of four AREDS formulations daily for five years:

• One group took the original AREDS included 500 milligrams vitamin C, 400 international units of vitamin E, 15 milligrams beta carotene, 80 milligrams zinc, and two milligrams copper

• Another group took AREDS with no beta-carotene

• Another, AREDS with low zinc (25 milligrams) or

• Another, AREDS with no beta-carotene and low zinc

Participants in each AREDS group also took one of four additional supplements or combinations: these included lutein/zeaxanthin (10 milligrams/ 2 milligrams), omega-3 fatty acids (1,000 milligrams), lutein/zeaxanthin and omega-3 fatty acids or placebo. Progression to advanced AMD was established by examination of retina photographs or treatment for advanced AMD.

Results: 2001 and 2013

•  In the first AREDS trial (2001), participants with AMD who took the AREDS formulation were found to be 25 percent less likely to progress to advanced AMD over the five-year study period, compared with participants who took a placebo.

•  In AREDS2 (2013), there was no overall additional benefit from adding omega-3 fatty acids or a 5-to-1 mixture of lutein and zeaxanthin to the formulation. However, the investigators did find some benefits when they analyzed two subgroups of participants: those not given beta-carotene, and those who had very little lutein and zeaxanthin in their diets.

Lutein and zeaxanthin seem to help

“When we looked at just those participants in the study who took an AREDS formulation with lutein and zeaxanthin but no beta-carotene, their risk of developing advanced AMD over the five years of the study was reduced by about 18 percent, compared with participants who took an AREDS formulation with beta-carotene but no lutein or zeaxanthin,” said Emily Chew, M.D., deputy director of the NEI Division of Epidemiology and Clinical Applications and the NEI deputy clinical director.

“Further analysis showed that participants with low dietary intake of lutein and zeaxanthin at the start of the study, but who took an AREDS formulation with lutein and zeaxanthin during the study, were about 25 percent less likely to develop advanced AMD compared with participants with similar dietary intake who did not take lutein and zeaxanthin.”

Because carotenoids can compete with each other for absorption in the body, beta-carotene may have masked the effect of the lutein and zeaxanthin in the overall analysis, Chew said. Participants who took all three nutrients had lower levels of lutein and zeaxanthin in their blood compared to participants who took lutein and zeaxanthin without beta-carotene.

Removing beta-carotene from the AREDS formulation did not curb the formulation’s protective effect against developing advanced AMD, an important finding because several studies have linked taking high doses of beta-carotene with a higher risk of lung cancer in smokers. Although smokers were not given a formulation with beta-carotene in AREDS2, the study showed an association between beta-carotene and risk of lung cancer among former smokers. About half of AREDS2 participants were former smokers.

“Removing beta-carotene simplifies things,” said Wai T. Wong, MD, PhD, chief of the NEI Neuron-Glia Interactions in Retinal Disease Unit and a co-author of the report. “We have identified a formulation that should be good for everyone regardless of smoking status,” he said. Adding omega-3 fatty acids or lowering zinc to the AREDS formulation also had no effect on AMD progression.

Many factors contribute to the development of AMD and cataract, including genetics, diet, and smoking. Scientists are unsure how supplements in the AREDS formulation exert their protective effects. However, an April 2013 report in the journal Ophthalmology by the AREDS Research Group shows the beneficial effects of taking the AREDS vitamins are long-lasting. The report describes a follow-up study of AREDS participants. Those who took the AREDS formulation during the initial five-year trial were 25 to 30 percent less likely to develop advanced AMD—mostly due to a reduction in the number of neovascular, or “wet,” AMD cases—over the next five years, compared with participants who took placebo during AREDS. Seventy percent of all participants were taking the original AREDS formula by the end of the follow-up period.

“Long-term use of AREDS supplements appears safe and protective against advanced AMD,” said Chew. “While zinc is an important component of the AREDS formulation, based on evidence from AREDS2 it is unclear how much zinc is necessary. Omega-3 fatty acids and beta-carotene clearly do not reduce the risk of progression to advanced AMD; however, adding lutein and zeaxanthin in place of beta-carotene may further improve the formulation.”

The AREDS2 study results provide physicians and patients with new information about preventing vision loss from AMD. People over 60 years old should get a dilated eye exam at least once a year and should discuss with their eye care professional whether taking AREDS supplements is appropriate.

For more information about AREDS2, visit Age-Related Eye Disease Study.

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New Approach Achieves Similar Outcomes to Fully HLA-Matched Conventional Donors

Thursday, August 22nd, 2013

by Asad Bashey, M.D., Ph.D.

From ATLANTA Medicine, 2013, Transplantation, Vol. 84, No. 1

Hematopoietic (marrow or peripheral blood stem cell) transplants from allogeneic donors (allo-HCT) can cure several hematological malignancies and some non-malignant diseases of the bone marrow or lymphoid system that are incurable with standard therapies. Traditionally, donors for allo-HCT have comprised either a matched (HLA-genoidentical) sibling (MRD) or an HLA-matched unrelated volunteer (MUD).  Only one of every four full siblings will be a MRD and thus given the size of the average American family, MRD are available for only 25-30% of patients.  Best results using MUD are achieved when the donor is fully matched with the recipient at least 8 of 8 HLA-A, B, C and DRB1 loci. Suitably matched MUD may be available for 70% of Caucasian patients if sufficient time is available to complete a formal donor search which can take up to 4-6 months.

However, many patients are in short-lived remissions from their malignancy and cannot afford to wait for the time required. For patients from ethnic minorities and mixed-race backgrounds optimally matched MUD are much less commonly found and this problem is particularly severe for African American patients.

Cryopreserved umbilical cord blood (UCB) has been used as an alternative donor source for such patients.  However, single UCB units often contain insufficient cells for an adult recipient. Two UCB units have been used to overcome this problem but the acquisition of two such units can be prohibitively expensive. Furthermore, UCB transplants can be associated with slow immunological recovery in adult recipients with associated prolonged risk of opportunistic infections and other post-transplant complications.

Partially-matched related donors, i.e. family donors with whom the patient shares an HLA-haplotype (also known as haploidentical donors) have also been investigated as an alternative donor source in patients who lack MRD and MUD.  Almost all patients who need an allo-HCT have a first degree relative with whom they share a HLA-haplotype.

Original studies performed in Seattle  in the 1970s and 80s demonstrated that un-manipulated allo-HCT from such haploidentical donors using the same regimens used  for MRD and MUD transplants  resulted in unacceptable rates of graft rejection and severe graft-versus-host disease (GVHD) due to aggressive bidirectional alloreactivity against the mismatched HLA-antigens. This led to the abandonment of haploidentical donor transplantation for several years.  Subsequently, investigators in Perugia, Italy developed an approach to allo-HCT from haploidentical donors that utilizes stringent depletion of T-cells from the graft to prevent GVHD and very intensely cytotoxic preparative regimens with anti-thymocyte globulin to prevent graft-rejection.  Although such transplants have been shown to be feasible and can cure some patients with acute leukemia, they are associated with high-rates of regimen-related toxicity and very slow immunological recovery with associated high rates of treatment related mortality1,2. Furthermore, the procedure is relatively complex and not easily replicated in other centers.

More recently an alternative approach to allo-HCT from haploidentical donors has been developed initially by Ephraim Fuchs and colleagues at Johns Hopkins University which uses unmanipulated (T-cell replete) bone marrow as the stem cell source in conjunction with a reduced-intensity (non-myeloablative) preparative regimen.  The procedure relies instead on the use of post-transplant cyclophosphamide (ptCy) to control bi-directional T-cell alloreactivity. Cyclophosphamide is an alkylating agent that is relatively sparing to hematopoietic stem cells and seems to preferentially target T-cells that are undergoing   activation and expansion in response to antigen stimulation. The approach administers high-dose cyclophosphamide on day +3 and +4 following the transplant when alloreactive T-cells are proliferating in response to the presence of mismatched HLA-antigens.

This process appears to selectively eliminate alloreactive T-cells responsible for graft-rejection and GVHD, while preserving other T-cells that are important for immunologic recovery3,4. Haplo-ptCy have been shown to result in low rates of GVHD, infections and  treatment related mortality in single and multi-center trials including a parallel phase-II comparison to UCB transplantation conducted by the Blood and Marrow Transplantation Clinical Trials Network (BMT-CTN)5. However, Haplo-ptCy have not been formally compared to allo-HCT performed using conventional MRD or MUD donors.

Successful haploidentical donor transplantation would be of particular benefit to the population of metropolitan Atlanta because of the relatively large proportion of minority, and in particular African-American, patients who reside in this area. At the BMT Program at Northside Hospital, we have studied the use of Haplo-ptCy transplants since 2005.  In addition to the non-myeloablative regimen originally developed at Johns Hopkins University, we have pioneered myeloablative regimens for Haplo-ptCy in patients with more aggressive and refractory malignancies in whom the non-myeloablative approach is unsatisfactory. We have demonstrated that the approach can be safe and effective with a low treatment related mortality and excellent disease-free survival in patients with advanced and refractory malignancies6.

However, despite the promising results of phase II studies of Haplo-ptCy transplantation, it has been unclear how the outcomes of such transplants compare to allogeneic hematopoietic transplants performed using optimally matched MRD and MUD.  In order to address this question we analyzed outcomes of 271 consecutive first allo-HCT performed for hematologic malignancy at Northside hospital between February 2005 and October 2010. Specifically, we compared outcomes following 53 consecutive Haplo-ptCy to 117 consecutive allo-HCT from MRD and 101 from MUD respectively performed at our center.

All transplants were performed contemporaneously at Northside Hospital using identical supportive care measures. The patients undergoing allo-HCT from the three types of donor were well matched with respect to age, gender, diagnosis, risk-profile of malignancy and co-morbidities. Haplo-ptCy patients were more likely to receive bone marrow rather than peripheral blood stem cell grafts and more likely to receive reduced intensity versus myeloablative preparative conditioning for transplant. A Cox proportional hazards analysis was conducted and outcome measures were adjusted for any difference in confounding variables between the three groups.  The results demonstrated that patients who underwent Haplo-ptCy transplants had similar overall and disease-free survival to patients transplanted from MRD and MUD.

Adjusted 24-month estimated survival rates were 76%, 67% and 64% for MRD, MUD and Haplo donor transplants respectively (p=n.s.). The corresponding 24-month rates of disease-free survival were 53%, 52% and 60% respectively. Cumulative incidences of non-relapse-mortality and relapse of malignancy were also not significantly different between the three groups. Rates and severity of acute GVHD were similar but cumulative incidence of extensive and severe chronic GVHD were lower in Haplo-ptCy transplant patients.  These results were presented at an oral session at the 53rd annual meeting of the American Society of Hematology meeting (December 2011, San Diego, CA, Abstract 833; Blood vol 118 (21) p380)

This study is the first to compare a large number of allo-HCT performed using Haplo-ptCy to contemporaneous allo-HCT performed from MRD and MUD at the same center. It shows that Haplo-ptCy transplantation produces similar outcomes to transplants performed from conventional donors. Thus, it establishes Haplo-ptCY transplantation as a valid standard of care in patients who lack a conventional donor. Because Haplo-ptCy transplantation avoids the purchase expense of an unrelated donor graft or unrelated cord blood units, and it does not require expensive ex-vivo T-cell depletion, its use has the potential to significantly alter the algorithm for donor selection for allo-HCT.  Haplo-ptCy transplantation is being compared to double UCB transplantation in an ongoing randomized phase III trial conducted by the Blood and Marrow Transplantation Clinical Trials Network (BMT-CTN trial 1101). Haplo-ptCy hematopoietic cell transplantation is also being explored as a means of establishing graft tolerance in recipients prior to solid organ transplantation.

References

1. Aversa F, Terenzi A, Tabilio A, et al: Full haplotype-mismatched hematopoietic stem-cell transplantation: a phase II study in patients with acute leukemia at high risk of relapse. J Clin Oncol 23:3447-54, 2005

2. Ciceri F, Labopin M, Aversa F, et al: A survey of fully haploidentical hematopoietic stem cell transplantation in adults with high-risk acute leukemia: a risk factor analysis of outcomes for patients in remission at transplantation. Blood 112:3574-81, 2008

3. Kasamon YL, Luznik L, Leffell MS, et al: Nonmyeloablative HLA-haploidentical bone marrow transplantation with high-dose posttransplantation cyclophosphamide: effect of HLA disparity on outcome. Biol Blood Marrow Transplant 16:482-9, 2010

4. Luznik L, O’Donnell PV, Symons HJ, et al: HLA-haploidentical bone marrow transplantation for hematologic malignancies using nonmyeloablative conditioning and high-dose, posttransplantation cyclophosphamide. Biol Blood Marrow Transplant 14:641-50, 2008

5. Brunstein CG, Fuchs EJ, Carter SL, et al: Alternative donor transplantation after reduced intensity conditioning: results of parallel phase 2 trials using partially HLA-mismatched related bone marrow or unrelated double umbilical cord blood grafts. Blood 118:282-8, 2011

6. Solomon SR, Matthews RH, Barreras AM, et al: Outpatient myeloablative allo-SCT: a comprehensive approach yields decreased hospital utilization and low TRM. Bone Marrow Transplant 45:468-75, 2010

 

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Dr. Miles Mason III Honored for Dedication to Quality Healthcare

Wednesday, August 21st, 2013

At its annual summer meeting, the Georgia Hospital Association (GHA) presented its prestigious Chairman’s Award to Miles Mason III, M.D., past president of the Gwinnett Medical Center (GMC) medical staff. Dr. Mason was recognized for long-time dedication to the hospital system and for bringing quality care to his community.

Candidates for the award are hospital trustees or executives who have made significant contributions to improving health care in Georgia. Dr. Mason has been a leader in the Gwinnett community for decades.

Dr. Mason opened a general surgery practice in 1979 and, two years later, was appointed as Gwinnett Health System’s medical staff president. He served in this capacity for seven years. He accepted the position again in 2000, serving for another 12 years.

In addition to his leadership role within the health system, Dr. Mason is a leader in his community. The youth of Gwinnett County have benefited from Dr. Mason’s work. In the early 1990s, he helped initiate a program to offer free sports physicals to students in the community and recruited colleague physicians to participate. In that decade, he screened hundreds of the county’s student athletes. The program was the seed for what has become the GMC Sports Medicine program, which provides full-time certified athletic trainers at local high schools and makes special concussion testing known as ImPACT (immediate post-concussion assessment and cognitive testing) available to thousands of student athletes.

Dr. Mason received his medical degree from and completed a residency at the Medical College of Georgia. He also completed a residency at Baylor University Medical Center. Prior to opening his general surgery practice, Dr. Mason served as a ship’s surgeon in the U.S. Navy and as a staff surgeon at Naval Medical Center Portsmouth.

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American Anesthesiology Physicians Develop Patient Safety Initiative

Wednesday, August 21st, 2013

American Anesthesiology, a national medical group based in Sunrise, Fla., is taking steps to improve patient care and outcomes through an innovative Patient Safety Initiative at its Atlanta-based practice.

The Patient Safety Initiative, a critical step in improving patient outcomes, is a comprehensive program designed to ensure that a “culture of safety” exists throughout the entire perioperative process. The program encompasses the same principles found in High Reliability Organizations (HRO), such as those in the aerospace and aviation industries. The Patient Safety Initiative was developed in conjunction with several former top-gun pilots who use these principles every day to ensure a culture of safety in the cockpit.

“Aviation is considered an HRO and healthcare should use aviation as a model to become one,” states Dr. Jeff Shapiro, medical director of American Anesthesiology’s practice at Piedmont Atlanta Hospital. “In both aviation and healthcare, safety is crucial in protecting lives and the need to be consistent and manage the unexpected is a constant.”

Shapiro’s practice is the pilot program for a national roll-out to the company’s 1,600 anesthesia providers throughout eight states.

American Anesthesiology’s Patient Safety Initiative, and its already proven results, could impact millions of patients across the country when rolled-out nationwide.  The foundational principles of the program are based on aviation’s tested Crew Resource Management training, which uses teamwork, communication, clearly defined roles, situational awareness, debriefing, checklists and permission to challenge. The program is already impacting and enhancing the culture of safety at his practice and in surgical patient care at Piedmont Atlanta Hospital.

“To Err is Human,” a report done in 1999 by the Institute of Medicine, states that healthcare in the U.S. is not as safe as it should be, and that nearly 100,000 people die in hospitals every year as a result of medical error. Beyond the cost of human lives are other “tolls” including billions spent on additional care necessitated by the errors; lost income, productivity and health status levels; loss of trust in the healthcare system; and loss of morale by healthcare professionals.

With an expected reduction in morbidity and complications associated with surgery, patient safety programs like this one are expected to reduce the aforementioned “tolls” and ultimately benefit practices, hospitals, insurance companies and most importantly – patients.

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Robotic Technology Allows Minimally Invasive Spine Surgery

Wednesday, August 21st, 2013

Physicians at North Fulton Hospital are now offering adults needing spine surgery a minimally invasive procedure using the Mazor Robot. This advanced technology, combined with the expertise of the hospital’s board certified orthopedic spine surgeons and neurosurgeons, may provide less rehabilitation from surgery and get patients back to normal activities much more quickly. Surgeons performed the first procedure using the robotic technology at the hospital on August 20.

Minimally invasive surgery means less pain, smaller incisions, shorter hospitalizations and faster recovery for the patient. But minimally invasive surgeries are also challenging due to the surgeon’s lack of direct line-of-vision, often requiring many intraoperative X-rays. The Renaissance™ Mazor Robotic spine system overcomes the issue of multiple x-rays, providing patients with the best possible clinical results with minimal intraoperative radiation.

The Renaissance™ is used to plan the surgery in a virtual 3D environment before anyone enters the operating room. This plan is then used to actively guide the surgeon during the procedure, allowing for much greater accuracy than traditional surgeries. Because the hardware and software tools enable a variety of spine procedures, it has a wide range of clinical applications including open surgeries, minimally invasive surgeries, osteotomies and biopsies. It is also particularly useful in surgeries involving pedicle screws for spinal fusions, disc replacement, scoliosis, and other complex spinal deformities.

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Canton Facility Offers Cardiac Catheterization and Interventional Radiology

Tuesday, August 20th, 2013

Northside Hospital-Cherokee has added a second suite to its Cardiac Catheterization/ Interventional Radiology Laboratory, located on the hospital’s campus in Canton.  Northside Hospital-Cherokee is the only provider of cardiac catheterization and interventional radiology services in Cherokee County. Annually, Northside Hospital-Cherokee performs approximately 1,000 cardiac and interventional radiology procedures.

Cardiac catheterization examines patients for blockages in the heart and coronary arteries.  The test examines blood flow in the arteries, blood flow and blood pressure in the chambers of the heart, and function of the heart.  Interventional Radiology is a subspecialty that allows specially-trained radiologists to see inside the body while guiding catheters and other instruments through blood vessels and other pathways of the body to perform minimally invasive procedures.

Northside Hospital-Cherokee’s Cardiac Cath Lab is staffed by specialized cardiac and radiology-trained nurses and technologists, who use state-of-the-art digital imaging technology to perform heart catheterization, interventional radiology procedures and other cardiac services including PCI (Percutaneous Coronary Interventions, or angioplasty), implantation of permanent pacemakers and AICDs (automatic internal cardiac defibrillators), stress tests, echocardiograms, nuclear medicine cardiac studies and more.

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