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Archive for the ‘Clinical’ Category

Immunizations

Monday, October 2nd, 2017

By Helen K. Kelley

While some diseases are becoming rare due to vaccinations, it’s important to acknowledge that they haven’t been completely eradicated. The viruses and bacteria that cause measles, mumps, chicken pox, flu, HPV and other illnesses still exist – and can easily be spread by people who have not been immunized.

We recently spoke with two Atlanta-area physicians who discussed the importance of immunizations for children and adults, improvements in vaccines and the challenges physicians face in ensuring that their patients know and understand the significance of receiving appropriate immunizations.

Advocacy for Pediatric Immunizations

Dr. Sam Gold

Dr. Sam Gold

Sam Gold, M.D., chair for pediatrics for WellStar Medical Group, began his career when new vaccines were just coming on the market for many common childhood diseases.

“I remember taking care of children who were in the intensive care unit for pneumococcal meningitis. We saw that scenario often, along with chicken pox and other diseases,” he says. “Seeing the big changes that were brought about by vaccines was exciting to me, and I became an advocate for children’s immunizations.”

Citing a resistance toward immunizations by many parents in the last 15-20 years, Gold says that he and his colleagues on WellStar’s pediatrics leadership team saw the need for improved communication, education and advocacy. This led to the creation of policies that standardize how WellStar pediatricians address the subject of immunizations with parents and deliver them to patients.

“In the past, each office determined how it handled the issue. Some offices allowed for parents who didn’t want to immunize their children, but that created problems with scheduling,” Gold says. “Choosing not to immunize creates risks not only for those kids, but also for others, especially infants who haven’t yet been vaccinated and children with nonfunctioning immune systems. Additionally, some parents would say they wanted to exclude only one particular vaccine.

“But our physicians have found that all childhood vaccines are important,” he adds. “Therefore, we require our patients to have all of the immunizations recommended by the Georgia Department of Health. Also, we have standardized, across the WellStar system, the manufacturers that supply our vaccines. This has helped reduce the potential for errors in efficacy of the vaccines.”

Gold adds that educating the public about immunizations is an important, albeit challenging, part of the advocacy puzzle.

“It is extremely difficult to get the true message out. With the rise of social media, there are many people who, even though they are not experts, can make claims to a large audience. It’s a pushback to science and hard to refute with expert proof,” he says. “We’re seeing a lack of understanding among parents because global health has improved so dramatically in the 20th century due to immunizations. Because they were immunized as children, parents today didn’t experiences measles and mumps and aren’t familiar with those diseases. It’s a double-edged sword. The vaccines have been so effective that they’ve made the reasons for having them seem so remote.”

Immunizations Important for Adults, Too

Dr. Sandra Fryhofer

Dr. Sandra Fryhofer

Sandra Fryhofer, M.D., agrees that education is the key to getting adult patients on board with the immunizations they need to stay healthy.

“Every year, thousands of adult Americans die of diseases that could have been prevented by vaccines. But some people are resistant to getting immunizations, often because they lack information,” she says. “That’s why a recommendation from a physician can go a long way toward helping patients understand why vaccination is important.”

Fryhofer, an internal medicine practitioner, says she includes a discussion of vaccines as a regular part of each patient’s annual physical exam.

“I might mention a particular vaccine and then let the patient read the vaccination statement about why they need it and what the possible risks are, so they can make an informed decision,” she says.

In addition to discussing standard vaccines such as flu, hepatitis B, HPV and pneumococcal pneumonia, Fryhofer counsels patients who are planning international travel about the immunizations they’ll need.

“I routinely ask patients about their travel plans, because talking to a doctor about their trip probably isn’t on their radar,” she says. “Because we live in a developed country with clean water and food, most people haven’t considered the medical dangers of traveling abroad where resources are not as reliable. They also haven’t considered the possibility of bringing some diseases, like measles, back into the U.S., where they can be transmitted to other people.”

Fryhofer encourages those who are planning to travel out of the country to make sure they are up-to-date on basic immunizations like tetanus, Tdap and MMR and to be prepared if they are going to countries where they will need to be immunized against diseases like cholera and yellow fever.

“It’s important to know what you need well in advance. For example, right now there is actually a shortage of YF-VAX, the vaccine for yellow fever, due to a delay in the manufacturing process,” she says. “The good news is, the FDA is allowing the importation of Stamaril, a yellow fever vaccine made in Europe. It’s available only at a limited number of locations, though, so people will have to consult the travel page on the CDC’s website to find those clinics. The best advice physicians can give their patients who are planning to travel abroad is to be informed and not wait until the last minute to get what they need.”

Fryhofer adds that doctors can help their patients and their peers by entering vaccine information into the Georgia Registry of Immunization Transactions and Services (GRITS) database.

“Keeping track of immunization information can be a challenge. When a physician administers a vaccine and enters the information into GRITS, other physicians and public health officials can access it,” she says. “It’s a helpful tool, ensuring that patients are up to date on the immunizations they need to stay healthy.”

New Microneedle Patch for Flu Vaccination

flu microneedle

Applying a dissolving microneedle patch. The microneedles dissolve within minutes after insertion into skin to release encapsulated drug or vaccine. Georgia Tech.

A National Institutes of Health-funded study led by a team from the Georgia Institute of Technology and Emory University has shown that an influenza vaccine can produce robust immune responses and be administered safely with an experimental patch of dissolving microneedles. The method is an alternative to needle-and-syringe immunization; with further development, it could eliminate the discomfort of an injection as well as the inconvenience and expense of visiting a flu clinic.

“This bandage-strip sized patch of painless and dissolvable needles can transform how we get vaccinated,” says Roderic I. Pettigrew, Ph.D., M.D., director of the National Institute of Biomedical Imaging and Bioengineering (NIBIB), which funded the study. “A particularly attractive feature is that this vaccination patch could be delivered in the mail and self-administered. In addition, this technology holds promise for delivering other vaccines in the future.”

The vaccine patch consists of 100 solid, water-soluble needles that are just long enough to penetrate the skin. Adhesive helps the patch grip the skin during the administration of the vaccine, which is encapsulated in the needles and is released as the needle tips dissolve, within minutes. The patch is peeled away and discarded like a used bandage strip.

The researchers enrolled 100 adult participants, dividing them into four random groups: vaccination with microneedle patch given by a healthcare provider; vaccination with microneedle patch self-administered by the study participant; vaccination with intramuscular injection given by a healthcare provider; and placebo microneedle patch given by a healthcare provider. The researchers used an inactivated influenza vaccine formulated for the 2014-15 flu season to inoculate participants other than those in the placebo group.

The researchers found that vaccination with the microneedle patches was safe, with no serious related adverse events reported. Some participants developed local skin reactions to the patches, described as faint redness and mild itching that lasted two to three days.

The results also showed that antibody responses generated by the vaccine, as measured through analysis of blood samples, were similar in the groups vaccinated using patches and those receiving intramuscular injection, and these immune responses were still present after six months. More than 70 percent of patch recipients reported they would prefer patch vaccination over injection or intranasal vaccination for future vaccinations.

The prospective vaccine technology could offer economic and manufacturing advantages. The manufacturing cost for the patch is expected to be competitive with prefilled syringe costs. The patch, however, can dramatically reduce the cost of vaccination, since self-administration can eliminate the need to have health workers oversee the process. It can be easily packaged for transportation, requires no refrigeration and is stable.

The team plans to conduct further clinical trials to pursue the technology’s ultimate availability to patients. They also are working to develop microneedle patches for use with other vaccines, including measles, rubella and polio.

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The Future of Valve Therapies

Monday, October 2nd, 2017

By Vivek Rajagopal, MD; Meredith Brazil, PA-C; Frances Lockwood, PA-C; Morris Brown, MD; Jim Kauten, MD; Christopher Meduri, MD, MPH

 

The gold standard for treating valve disease for decades has been cardiac surgery, but transcatheter valve therapies have proved effective in numerous clinic trials. In particular, clinical trials have shown superior outcomes of transcatheter aortic valve replacement (TAVR) in patients considered at high or extremely high risk for cardiac surgery.

Furthermore, over the last several years, transcatheter aortic valve replacement has proved to be noninferior in patients considered at intermediate risk for cardiac surgery.  Finally, transcatheter aortic valve replacement is being tested in patients considered low risk for cardiac surgery, and transcatheter mitral and tricuspid valve therapies continue to be developed and tested in clinical trials as well.

TRANSCATHETER AORTIC VALVE REPLACEMENT

Since the first transcatheter aortic valve replacement (TAVR) in 2002 by Alain Cribier(1), numerous clinical trials have shown the safety and efficacy of TAVR in a broad range of patients. The first trial, PARTNER B, randomly assigned patients at prohibitive risk for cardiac surgery to continued medical therapy versus TAVR with a balloon-expandable valve, and TAVR reduced one-year mortality from approximately 50 percent to 30 percent(2).

A similar trial using a self-expanding valve also showed marked reduction in mortality compared to that predicted without treatment(3). In patients considered at high risk for cardiac surgery but operable, the PARTNER A trial showed noninferiority of TAVR to surgical AVR(4). Adding to this, another trial of such patients showed superiority of TAVR to surgical AVR with respect to risk of mortality and stroke(5). For these reasons, TAVR has become the standard of care for patients with aortic stenosis who are considered at high or extreme risk for cardiac surgery.

Furthermore, data continues to accumulate for TAVR in even lower-risk patients. For example, the PARTNER IIA trial randomly assigned “intermediate risk” patients to either TAVR or surgical AVR(6). In the entire trial, TAVR was noninferior to surgery with regard to death or disabling stroke, but in the patients who received the transfemoral-access TAVR (least invasive form of TAVR), the rate of death or disabling stroke was actually lower with TAVR.

Because another trial demonstrated noninferiority of TAVR to surgery, it is clear that TAVR is acceptable, and is in fact approved by the FDA, for these patients(7). In the final phase of this revolution, TAVR is now being compared to surgery in patients considered at very low risk for surgery in two clinical trials of different TAVR valves (Figure 1) (8).

Medtronic Evolut TAVR

Figure 1: Medtronic Evolut TAVR

edwards sapien 3 TAVR

Figure 1: Edwards Sapien 3 TAVR

At the Piedmont Heart Institute, we are proud of our team’s contribution to this revolution. Not only have we had excellent experience and outcomes with the TAVR valves tested in these clinical trials, but we are also the only center in the Southeast performing TAVR with cerebral protection in the REFLECT trial, which is aiming to show a reduction in stroke related to TAVR (already infrequent)(9).

TRANSCATHETER MITRAL VALVE REPAIR AND REPLACEMENT

Like those with aortic stenosis, patients with severe mitral valve disease also suffer; they have progressive symptoms of congestive heart failure, with recurrent hospitalizations and increased risk of dying. Although open-heart surgery has been the standard treatment for decades, a substantial proportion of patients are high risk for surgery, and transcatheter valve treatments are playing a greater role in these patients.

mitral valve repair

Figure 2: Catheter-based Mitral Valve Repair

The first approved transcatheter mitral valve therapy was the MitraClip, which reduces mitral regurgitation by simulating a surgical technique called the Alfieri stitch, which binds the leaflets together, thereby allowing better co-aptation (Figure 2). In the EVEREST II trial, MitraClip was safe and effective, although not as effective as surgical therapy (10). Nonetheless, the FDA approved the MitraClip for patients considered high risk for surgery because of its safety, and because patients successfully treated with MitraClip had a marked reduction in risk of heart failure hospitalization after therapy.

In patients with heart failure and mitral regurgitation specifically because of poor left ventricular function, the ongoing COAPT trial is investigating the role of MitraClip for this type of mitral regurgitation (“functional MR”). As the leading enroller of patients for COAPT in the Southeast, Piedmont Heart Institute will continue to advance the science of transcatheter mitral valve repair so that we all can take better care of these patients.

We are also excited to advance the science of transcatheter mitral valve replacement (TMVR), which, like TAVR, is a minimally invasive replacement for the mitral valve and will likely be a viable alternative to MitraClip for patients who would benefit from replacement instead of repair. Many TMVR prostheses have shown promise in early feasibility trials around the world (11). In July 2016, our team at the Piedmont Heart Institute performed the first Medtronic Intrepid valve implantation in the United States, and we continue to lead the country in this early trial.

TRANSCATHETER TRICUSPID VALVE REPAIR

Like aortic and mitral valve disease, tricuspid valve disease can also lead to progressive heart failure.  Patients with tricuspid valve disease, however, are even less likely to receive cardiac surgery because they tend to have right ventricular dysfunction and/or pulmonary hypertension, which are very high-risk features for surgery.

Tri-align system

Figure 3: Tri-align system

For these reasons, development of transcatheter tricuspid valve repair is exceedingly important, and several technologies are in either preclinical development or in early human studies (12). The first early feasibility study published was the SCOUT trial, which investigated the TriAlign system (Figure 3); this system allows physicians to put sutures around the tricuspid annulus and bring the sutures together, thereby shrinking tricuspid annular dimensions with reduction in tricuspid regurgitation (13).

The procedure proved safe in all patients, with dramatic improvement in the New York Heart Association (NYHA) class and Minnesota Living with Heart Failure Questionnaire score. The Piedmont Heart Institute enrolled in this trial and is now the most experienced center in the world with this technology. In fact, our team performed the world’s first transcatheter tricuspid valve repair with the TriAlign system in a patient with a pacemaker lead.

Over the next few years, we will continue to see an explosion in development of transcatheter valve therapies. For patients suffering from valve disease, particularly those who are too old, too frail or too sick for cardiac surgery, this revolution offers comfort, options and hope. We at Piedmont Heart Institute are grateful to be part of this, and we are grateful to our patients for allowing us to care for them.

 

References

  1. Cribier A, Eltchaninoff H, Bash A et al. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation 2002;106:3006-8.
  2. Leon MB, Smith CR, Mack M et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. The New England journal of medicine 2010;363:1597-607.
  3. Popma JJ, Adams DH, Reardon MJ et al. Transcatheter aortic valve replacement using a self-expanding bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery. Journal of the American College of Cardiology 2014;63:1972-81.
  4. Smith CR, Leon MB, Mack MJ et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. The New England journal of medicine 2011;364:2187-98.
  5. Adams DH, Popma JJ, Reardon MJ et al. Transcatheter aortic-valve replacement with a self-expanding prosthesis. The New England journal of medicine 2014;370:1790-8.
  6. Leon MB, Smith CR, Mack MJ et al. Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients. The New England journal of medicine 2016;374:1609-20.
  7. Reardon MJ, Van Mieghem NM, Popma JJ et al. Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients. The New England journal of medicine 2017;376:1321-1331.
  8. Saji M, Lim DS. Transcatheter Aortic Valve Replacement in Lower Surgical Risk Patients: Review of Major Trials and Future Perspectives. Current cardiology reports 2016;18:103.
  9. clinicaltrials.gov. The REFLECT Trial: Cerebral Protection to Reduce Cerebral Embolic Lesions After Transcatheter Aortic Valve Implantation. 2017.
  10. Feldman T, Kar S, Elmariah S et al. Randomized Comparison of Percutaneous Repair and Surgery for Mitral Regurgitation: 5-Year Results of EVEREST II. Journal of the American College of Cardiology 2015;66:2844-54.
  11. Regueiro A, Granada JF, Dagenais F, Rodes-Cabau J. Transcatheter Mitral Valve Replacement: Insights From Early Clinical Experience and Future Challenges. Journal of the American College of Cardiology 2017;69:2175-2192.
  12. Rodes-Cabau J, Hahn RT, Latib A et al. Transcatheter Therapies for Treating Tricuspid Regurgitation. Journal of the American College of Cardiology 2016;67:1829-45.
  13. Hahn RT, Meduri CU, Davidson CJ et al. Early Feasibility Study of a Transcatheter Tricuspid Valve Annuloplasty: SCOUT Trial 30-Day Results. Journal of the American College of Cardiology 2017;69:1795-1806.
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Glaucoma:

Wednesday, August 30th, 2017

Increasingly Common as the Population Ages but Treatment Has Never Been Better!

By Elma Chang, M.D. and Reay Brown, M.D.

Three million people in the U.S have glaucoma – an asymptomatic, blinding eye disease. At least 1 million of these victims don’t even know they have it, which is why glaucoma is called the “Thief in the Night.” Detecting glaucoma is one of the main reasons we recommend an eye exam every 1 or 2 years, even for people who feel like they are seeing very well.

The fluid inside the eye has a natural circulation designed to achieve a normal internal pressure. Normal pressure should be defined as any pressure that does not cause optic nerve damage with a corresponding visual field defect. Using this argument, the previously accepted thought that a patient cannot have glaucoma if the eye pressure is below 21 is false. In the same way, if a patient has an eye pressure above 21 but no coexisting optic nerve damage, the patient is diagnosed with ocular hypertension and not glaucoma.

In a patient where it has been established that the optic nerve has thinning that corresponds with a visual field loss, visual fields are obtained on an annual basis. Peripheral vision is slowly – and imperceptibly – lost. If undetected and untreated, the eye may become totally blind. Since glaucoma is usually bilateral, patients too often present with blindness in one eye and advanced visual loss in the other. However, this progressive damage can be slowed or stopped completely by treatments that reduce the eye pressure to a normal level.

Fortunately, we have many excellent treatments for glaucoma. Eye drops are usually the first line of treatment. These lower pressure by enhancing outflow and reducing the fluid production. The next step is laser treatment – a very safe and effective option that is performed in the office and only takes a few minutes.

Cataract surgery has been found to be a very effective intervention for lowering eye pressure even though its main goal is to improve vision. We also have several devices (iStent, CyPass, and Xen implants) that we can place at the time of cataract surgery, and these have been breakthroughs in glaucoma treatment. Patients who need further pressure lowering will receive a trabeculectomy or a tube-shunt.

Medications – Both Now and the Future

Eye drops that decrease fluid production are beta-blockers (timolol maleate, Betimol, Timoptic), adrenergic agonists (brimonidine, Alphagan) or topical and oral carbonic anhydrase inhibitors (dorzolamide, Azopt, acetazolamide, Diamox). Medicines that promote outflow are cholinergic agonists (Pilocarpine), adrenergic agonists and prostaglandin analogs (latanoprost, Lumigan, Travatan, and Xalatan).

Rhopressa is a newer topical medication that is awaiting final FDA approval and will be available soon. It acts via rhokinase inhibition. This has been found to increase both aqueous outflow through the trabecular meshwork and reduce episcleral venous pressure.

Newer Delivery Systems

Eye drops require that patients use them once or twice daily. Compliance has been a major obstacle in treating glaucoma patients. Studies have shown that as many as 80 percent of patients forget to take their eye drops. Sustained drug delivery devices may be one key to improving compliance.

One device is a ring that is placed under the upper and lower lids. Another device is placed in the tear punctum in the lower lid. These devices are in studies and have shown good results.in reducing intraocular pressure (IOP) for up to 6 months.

Other studies have examined the use of particulate drug delivery systems or injectable formulations such as microspheres, liposomes and nanospheres/nanoparticles. This involves trapping the drug in the nanocarrier matrix and releasing the bioactive agent in a controlled fashion after administration.

It is impossible to know which of these technologies will emerge as the best option, but it is clear that longer duration treatments are a critical unmet need. We will continue to see rapid improvement in these technologies.

Laser Surgery

Laser surgery has traditionally been used as an intermediate step between topical therapy and incisional surgery. Laser therapy can increase outflow of fluid through the trabecular meshwork (laser trabeculoplasty) or decrease aqueous production from the ciliary body (diode laser cyclophotocoagulation). Laser trabeculoplasty can easily be performed in the office setting.

The Micropulse laser is a newer laser technology that seeks to improve the safety of the traditional diode cyclophotocoagulation while preserving the pressure-lowering.

Cataract Surgery with MIGS

One of the major recent advances in glaucoma treatment has been the discovery that cataract surgery lowers pressure and that the magnitude of pressure reduction was proportional to the pre-op intraocular pressure. In other words, cataract surgery is also a glaucoma operation that lowers pressure best in patients who need it the most.

There are 3.5 million cataract operations each year in the U.S., and studies show that as many as 20 percent of these patients have a concurrent diagnosis of glaucoma. So, this is all very good news for glaucoma patients.

Cataract and glaucoma are also linked because the two new devices that have been approved for glaucoma treatment – the iStent and CyPass – are restricted for use only at the time of cataract surgery. They can be used “off-label” as stand-alone procedures, but insurance coverage is more uncertain.

Image 1

The iStent (Image 1) and CyPass (Image 2) are the first devices in the category of micro-incisional glaucoma surgery or MIGS. MIGS is a revolution in glaucoma treatment. MIGS approaches are much safer than conventional glaucoma surgery.

One of the key differences between MIGS and traditional glaucoma surgeries is the approach to the eye’s outflow system. Specifically, an ab interno approach is used in MIGS where the surgeon is able to access the trabecular meshwork (iStent) or suprachoroidal space (CyPass) via a corneal incision. Previously, the outflow system was approached via an ab externo approach, which meant that the outflow system was accessible only after resecting back conjuntival and scleral tissues.

There are many new approaches in the MIGS category. These include the ability to thread a catheter in the space behind the trabecular meshwork (canaloplasty) and then pull the catheter through the meshwork and creating an opening in the trabecular meshwork (goniotomy). A similar goniotomy effect can be achieved with several new technologies – the Trabectome, the Kahook blade and the Trab360 device.

Image 2

Incisional Surgeries – Now and What’s on the Horizon

In some cases, treatment with eye drops, laser, cataract surgery and MIGS may not be enough to halt glaucoma damage. The next step is a trabeculectomy or a tube implant. These procedures create a pathway – essentially a hole – from inside the eye to a bleb (a fluid-filled bump) on the ocular surface. This can achieve profound pressure reduction but has a greater risk of infection, IOP being too low for clear vision, double vision and failure.

Finally, the newest device to achieve FDA approval is the Xen gel implant. This device is also implanted ab interno via a corneal incision. It is a newer and less invasive way to perform the trabeculectomy. The goal is to implant a gel-like Xen material in the subconjunctival space. The implant itself maintains a passageway between the anterior chamber and the subconjunctival space. The hope is that this will be safer than a traditional trabeculectomy but just as effective in lowering IOP.

The pace of innovation in glaucoma treatment is accelerating – both for topical therapy and for surgery. Most glaucoma surgeons still perform traditional glaucoma surgeries (trabeculectomies and tube implantations), but the acceptance of MIGS devices and technology is growing.

Our practice has been involved with some of the research that led to the development of the iStent and with the studies that led to the approval of the CyPass. We believe that MIGS is fundamentally changing the glaucoma treatment paradigm with surgical approaches becoming more common.

But these innovations are just the beginning. We have never had so many outstanding options for treating glaucoma and tailoring the approach to each patient. No one should ever become blind from glaucoma.

 


Radcliffe NM, Lynch MG, Brown RH. Ab interno stenting procedures. J Cataract Refract Surg 2014;40:1273–1280.

Brown RH, Zhong L, Lynch, MG. Lens-based glaucoma surgery: Using cataract surgery to reduce intraocular pressure. J Cataract Refract Surg 2014;40:1255–1262.

Brown RH, Zhong L, Lynch MG. Clear lens extraction as treatment for uncontrolled primary angle-closure glaucoma. J Cataract Refract Surg 2014;40:840–841.

Brown RH, Zhong L, Whitman AL, Lynch MG, Kilgo PD, Hovis KL. Reduced intraocular pressure after cataract surgery in patients with narrow angles and chronic angle-closure glaucoma. J Cataract Refract Surg, 2014; 40:1610-1614

Brown RH, Gibson Z, Zhong L, Lynch MG. Intraocular pressure reduction after cataract surgery with implantation of a trabecular microbypass device. J Cataract Refract Surg, 2015 41: 318-319

Vold S, Ahmed IK, Craven R, Mattox C, Stamper R, Packer M, Brown RH, Ianchulev T. For the CyPass Study Group, Minimally invasive surgical treatment for glaucoma: 2-year pivotal RCT results of supraciliary microstenting. Ophthalmology 2016; 1-10.

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Cosmetic Applications of Lasers and Light/Energy-based Devices

Wednesday, August 30th, 2017

By Rutledge Forney, M.D.

Helping children with facial port wine stains was the first cosmetic usage of laser energy. Since then, our understanding of energy in the skin has grown exponentially.

Today, lasers and other light/energy-based devices have dozens of cosmetic applications. From hair to brown spots to wrinkles and much more, demand for non-invasive (non-surgical) procedures has exploded as the baby boomers have aged.

A laser wavelength targets and destroys a specific “chromaphore,” or colored molecule, and can focus at different levels in the skin to minimize damage. Research into tissue temperature sensitivity has brought new ways to tighten skin and “kill” fat. Cosmetic market competition is strong, so these devices have to be effective to replace surgery and older technology. This article will provide an overview and act as a primer for the reader.

Vascular Targets

Pulsed dye and KTP lasers are the gold standards for facial veins and redness. Birthmarks, rosacea, angiomas and sun damage respond well to the 532, 585 and 595 nanosecond wavelengths. Multiple manufacturers make devices with these settings, with the differences being the method of cooling the skin, spot sizes and pulse length.

Leg veins are harder to treat with lasers due to thick skin and pressure in the legs from gravity. 1064 NdYag lasers are marketed to help leg veins, but every lecture I go to on leg veins and lasers confirms that the gold standard for leg veins is still sclerotherapy.

Brown Spots

All brown spots are not created equal! Some are sun damage, some are genetic. Some are superficial, some deep. Some are from hormones, some from acne or trauma. But all brown spots are universally despised. Lasers can help some, not all, brown spots. Lasers can darken brown spots from hormones (melasma).

Many different lasers and light-based devices target brown spots. Classically, intense pulsed light (IPL) – not a laser but a spectrum of light – is used to treat an area of sun damage, principally on the face, neck, chest and arms. Over a few days, obvious and not-so-obvious brown spots disappear. Remaining brown spots may be cleaned up individually with new picosecond lasers and 810 and 1064 wavelengths lasers.

Hair Reduction

The most common use of cosmetic laser therapy today is hair reduction. Dark hair in light skin can be treated effectively. Unfortunately, light hair does not have a “chromophore” to attract a laser, and dark hair in dark skin cannot be “seen” by the laser. Hair reduction wavelengths are commonly 810 in lighter skin, 1064 in darker skin. IPL is used for hair reduction but with a higher risk of hyperpigmentation and blistering due to multiple wavelengths hitting unintended targets.

Skin Texture, Wrinkles and Collagen Refreshment

Aging, primarily sun damage, causes large pores, wrinkles/crinkles and droopy skin. Compare the skin on your lower abdomen or buttocks (which typically has less sun damage) to that of your hands or face. A biopsy of 60-year-old sun-damaged skin compared to young sun-protected skin shows frayed, crinkled collagen and increased elastin. Anyone can tell the difference.

According to The New York Times, collagen production is stimulated by three things. One: laser resurfacing, which gets energy into the dermis where most damaged collagen is found. Two: prolonged use of tretinoin. Three, dermal fillers, which are used to plump thin lips, enhance contours, soften facial creases, remove wrinkles and improve the appearance of recessed scars. Enough said.

In the 1990s, two laser wavelengths were used for full face resurfacing, CO2 and Erbium Yag. They completely removed the epidermis and tightened the dermis. Folks who got a great result were thrilled, but not all got a home run. Poor healing and infection could impair results. It was expensive and usually required general anesthesia. Patients needed to lay low for 3 weeks, keeping the face moist, covered and out of the sun until the epidermis reformed. Scarring and hypopigmentation were not uncommon. Still, the demand for improvement in aged skin motivated research into other options.

In 2005, the fractionated laser was born. It lasered 20 percent, not all of the epidermis and superficial dermis, leaving columns of lasered skin surrounded by normal skin. This assured that the lasered skin was excreted and the damage healed quickly without scarring or hypopigmentation. The original wavelength was 1550; five treatments resurfaced the face for maximum results. Fractionated lasers now include 1550, CO2 and Erbium Yag. Multiple treatments are necessary, with some downtime, but not the risks of non-fractionated lasers.

Skin Tightening

Radiofrequency and ultrasound are now used to tighten skin without surgery. Both go through the epidermis into the dermis without damaging the skin, so they have no downtime. Radiofrequency heat contracts dermal collagen while ultrasound focuses on lower levels of the dermis. Some devices add microneedles to wound the epidermis and deliver focused radiofrequency waves deeper in the skin to tighten both epidermis and dermis.

Fat Destruction and Body Sculpting

Fat is the latest frontier in noninvasive, in-office procedures. Liposuction has been used for decades to remove fat cells in localized fat pockets. Laser-assisted liposuction was developed about 15 years ago to make the process less traumatic and to tighten skin from the inside. Knowledge that fat is temperature sensitive led the developers of the fractionated laser to focus on ways to destroy fat noninvasively. A technique to freeze fat while protecting the overlying skin and underlying muscle was first approved by the FDA in 2010 and is now considered by many to be the gold standard for noninvasive fat destruction. It takes three months to see results; the tradeoff is no cuts, stitches and invasive suction, which is worth it to many.

Cold kills fat, but so do heat and ultrasound! Radiofrequency waves and focused 1064 lasers are used to heat fat. Deep ultrasound is being used to target fat pockets as well.

Tattoo Removal

Tattoo removal is challenging. It involves multiple chromophores (colors), hence multiple wave lengths. The science is that the laser hits the ink and breaks it into smaller pieces, which the body’s macrophages carry away. It typically involves multiple treatments about every 2 months, with eight to 20 total treatments necessary.

A breakthrough in tattoo removal came with the development of a picosecond laser. (All conventional cosmetic lasers are nanoseconds.) This extraordinarily fast laser adds acoustic energy, breaking ink into smaller pieces so it is removed faster, requiring only three to eight treatments.

Obviously, there are many devices and methods that improve the appearance of skin and the body. Young skin reflects light, is smooth and one color. Photo-aging results in dyschromia (multiple colors in the skin: reds and browns of multiples shades), prominent vessels, a rough texture, enlarged oil glands and folds in the skin. The skin is dull with permanent lines from smiling and frowning (motion).

The underlying problems are that collagen and blood vessel walls are damaged by sun and free radicals, and the body’s protective pigmentation eventually cannot be totally removed because the removal processes are tired and worn out.

Not every machine is right for every person. The physician directing treatment must understand the color of the skin. Though operating lasers and other cosmetic devices can be delegated, the devices discussed here require the direction of a physician.

Remember that if one only has a hammer, then everything will look like a nail. Make sure that the physician understands the patient’s goals and that the physician and the patient are sure that the treatment is right for that patient.

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From Office Surgery to Face Lifts

Wednesday, July 19th, 2017

By Elizabeth Morgan, MD PhD FACS

“Can it be done in the office?” and “Do I need a face lift?” are two common questions that cosmetic surgery patients ask us.

Today, short-acting general anesthetics and advanced monitoring make general anesthesia very safe, safer than intravenous sedation — one reason that anesthesiologists prefer this approach. Indeed the dangers of sedation without airway control are such that the American Society of Plastic Surgeons requires members to restrict its use to accredited out-patient surgery centers. But most people dislike the cost of a surgery center, as well as the recovery from general anesthesia, and avoid it if possible.

What can a plastic surgeon today offer the patient who wants the lower cost and faster recovery of a procedure done in the office with local anesthesia, perhaps with one or two light sedative pills at most?

Surprisingly we can offer a lot of safe office operations. This isn’t just our ingenuity but our response to patients wanting solutions to a wider range of cosmetic issues. Today I can safely offer my patients 50 such procedures with continuous monitoring of pulse, blood pressure and pulse oxygenation to ensure the surgery is in fact safe.

Such operations include small-volume liposuction, small-volume fat transfers, lip lifts, lip implants, buccal fat reductions, face lift revisions, skin-only tummy tucks, ear lobe repairs and reductions, chin implants, elbow lifts, buttock lifts, upper lid lifts, lower lid lifts, correction of nipple eversion and inversion, labiaplasties, brow lifts, alar nose reduction, ear setbacks, implant exchanges and much more.

Figure 1A

Figure 1B

Not every patient or problem is suited for local anesthesia surgery, but what can be done is remarkable. Incremental advances in our understanding of local anesthetics and cosmetic surgery have expanded our patients’ options while making these procedures almost painless.

Indeed the pain from many of these operations is much less than for filler, Botox or Kybella injections. For instance, pain from local anesthesia for a lip lift (see Figure 1 A and B) is two spot skin injections or four seconds, compared to the severe pain from Kybella fat injection of the neck (see Figure 2 A and B),which lasts five minutes. This is 75 fold less pain!

Figure 2A

Figure 2B

Indeed the ease and recovery from such procedures makes patients want all cosmetic surgery done this way. The day may come — but it’s not here yet. Why not? Office surgery should take not much more than two hours for patient comfort, cannot be safely done in a hypertensive or hyper-anxious patient or if there is a risk of fluid shifts, unexpected bleeding, unsafe levels of local anesthetic or damage to vital structures. Major surgery with these risks belong in an accredited surgery center.

Although mini-face lifts can be done in the office, surgery tends to be limited and results less durable. So far in my practice, an in-office mini-face lift seems a poorer choice than a well-done standard face lift in a surgery center, which will typically produce good to outstanding durable results with a low risk of complications. (See Figure 3A and B.)

Figure 3A

Figure 3B

This leads to the question — what is a standard face lift? It is a ‘bespoke’ or ‘designer’ lift, based on the patient’s facial changes and the available techniques. Here is how that approach is evolving.

From the early 1910s to 1968, face lifts just tightened skin. By the late 1960s, all of the neck skin and much of the facial skin was being raised off the deep layers beneath. Results could be good but were unpredictable.

In 1968, Tord Skoog, a Norwegian plastic surgeon, introduced his deep layer face lift. By raising and tightening the deep layer of the face — a fascial layer he called the submusculo-aponeurotic system (SMAS) — he improved face lift results and durability. But the SMAS flap was often fragile and hard to suture. Facial nerves travel under the SMAS and could be injured. So face lifting branched in two directions, less and more. Which approach a modern plastic surgeon uses depends on her/his assessment of risk and of the patient’s needs.

Doing less led to SMAS excision or plication — tightening with SMAS without lifting it. Nerve injuries were rarer, and results were very good. This then led to the ‘mini-lift,’ which uses a short incision in front of the ear to tighten just the SMAS. The results are less durable and eventually led to ‘suture’ and ‘thread’ lifts, a recurring ‘face lift’ fad with little durability.

Doing more led to sub-periosteal face lifts, which lifted the facial tissues off the bone, now largely replaced by the composite face lift championed by Dr. Hamra. This procedure leaves the skin attached to the SMAS and extends further into the mid-cheek and lifts the lower lid and brow as well. Results can be superb, but the extent of surgery, longer recovery and greater risk led many surgeons to only incorporate elements of this lift into their face lifts, as needed.

Figure 3

Meanwhile back in the lab, plastic surgeons were dissecting cadaver faces to understand facial aging. Why do our faces age differently from those of all other animals? Faces of the dog and cat, mandrill and camel do not sag as ours do. (See Figure 3.) Here’s what we learned.

First we learned that aging causes loss of facial fat, deflating the face. The advent of fillers, fat injections and soft solid silicone implants allows us to restore some of this youthful facial fullness. But this is only part of a fascinating story.

Another part is that our muscles of facial expression differentiate us from other animals. These muscles lie in the SMAS, kept in place with ligaments that attach skin and SMAS to bone beneath along a line going from lateral brow to angle of the jaw. These ligaments separate the mobile, expressive front of our face from the immobile sides.

In front of each ligament is a ‘potential space,’ a glide plane that allows the muscles to move. We move them constantly! This repetitive motion plus aging and sun damage will stretch the skin, subcutaneous fat and SMAS, causing them all to bulge out over the ligaments, forming the jowls, facial folds, saggy cheeks and bulgy lower lids of “age.”

Further, aging causes thinning, weakening and absorption of tissue in every layer of the face, from skin and fat to periosteum and bone. By our mid-20s, signs of aging are seen in Caucasian women. Because of men’s thicker tissues, these changes are seen later, in the early 30s. Those with even thicker facial tissues have even later visible signs of aging, as is evident in many Americans of Asian and African descent.

But no worries for early agers, right? Now that we know the anatomy in detail, can’t we just tighten those SMAS tissues around the ligaments? Not so fast! The nerves lie in the ligaments. Releasing ligaments can cut those nerves.

But our new knowledge does provide an answer. We now know how to find the glide planes between the ligaments — these are safe spaces where SMAS and skin can be tightened away from ligaments and nerves. This approach provides a limited dissection, less risky composite face lift, an approach being incorporated in face lifts today — yet another important incremental step forward.

Meanwhile, plastic surgeons and others are exploring another avenue: stem cells and other biotechnology to rejuvenate aging tissues. The ultimate irony for plastic surgeons would be if our own research leads to pills, creams or safe injections that restore the face to a youthful appearance permanently without surgery, injections or implants.

While we await this Fountain of Youth, we have ever better face lifts and a panoply of office procedures to offer our patients. It’s astonishing progress from the introduction of general anesthesia in 1844 and local anesthesia in 1888!

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Gynecology Spotlight

Wednesday, July 19th, 2017

By Helen K. Kelley

Atlanta Medicine recently spoke with some Atlanta-area gynecologists to learn about new effective surgical techniques, comparisons of surgeries in terms of costs and advantages, and how conversations about family planning and contraception choices are reducing the number of unintended pregnancies among their patients.

New tissue removal techniques for hysterectomy

Algernon O. Steele, a board-certified gynecologist with Southeast Permanente Medical Group, says that new techniques for removing tissue have allowed a return to minimally invasive surgery for hysterectomies.

Dr. Algernon Steele

“One of the problems we had in the progression of minimally invasive gynecological surgery was the ability to remove larger uteruses and fibroid tumors from the body,” he says. “This tissue removal was greatly facilitated by the use of a power tissue morcellator, which allowed us to cut the tissue into smaller pieces that could then be removed through a small laparoscopic incision. However, in the last three years, the FDA discouraged its use for uterine procedures, issuing a warning that morcellators may spread occult cancer in the course of surgery. As a result, some hospitals chose to completely ban the device.”

With the morcellator out of commission for gynecological use, what would have been laparoscopic hysterectomies in some cases became total abdominal hysterectomies. The abdominal surgeries included longer recovery times, larger blood loss and higher morbidity rates.

Steele says that new tissue removal techniques have allowed gynecologists to return to performing minimally invasive hysterectomies.

“We can now use tissue containment bags that can be used through a small incision to manually remove a larger uterus or fibroid in a contained way,” he says. “We put the specimen in the bag, use a scalpel to cut it into smaller pieces and remove them through the incision.”

Newer devices are being developed that will allow power morcellation to take place within a bag. Steele adds that the banning of the tissue morcellator is still a controversial topic.

“For women under age 50, the known risk of spreading cancer by using a morcellator is very low,” he says. “However, the data is still being collected. And if it happens to even one person, there are people who would say that is one too many.”

 

Comparative study of vaginal, abdominal and robotic laparoscopic hysterectomy

During a presentation at the 65th annual meeting of the American College of Gynecology in May, Magdi Hanafi, M.D., a board-certified gynecologist with Gyn & Fertility Specialists, spoke about a comparative study he conducted among vaginal, abdominal and robotic laparoscopic hysterectomies. The study, which included 122 patients with symptomatic leiomyomata at Saint Joseph’s Hospital of Atlanta (now Emory Saint Joseph’s Hospital) took place from February 2007 to June 2009. Participants underwent either robotic-assisted laparoscopic myomectomy or abdominal myomectomy.

Dr. Magda Hana

The study compared short-term surgical outcomes of robotic and abdominal myomectomy and analyzed the factors affecting the short-term outcomes. The variables investigated included the type of surgery, age, body mass index, gravity, parity, number of leiomyomata, diameter of largest tumor size, total operative time, estimated blood loss and length of hospital stay.

“The study found there were no significant differences between the two groups regarding age, gravity and parity. However, BMI, numbers of leiomyomata and tumor sizes were significantly higher in abdominal myomectomy compared with robotic-assisted laparoscopic myomectomy,” Hanafi says. “While the total operative time was significantly longer in robotic-assisted laparoscopic myomectomy compared with abdominal myomectomy, estimated blood loss and length of hospital stay were significantly lower. We concluded that blood loss, post-operative pain, length of hospital stay and cost were significantly higher for abdominal hysterectomy versus all other methods.”

Hanafi adds that robotic surgery has many advantages for both patient and surgeon.

“First, robotic surgery has reduced the number of open surgeries. We have improved visibility and are able to do more precise work as surgeons,” he says. “This results in an improved quality of post-operative care and better outcomes for patients.”

 

Long-acting contraceptive methods, family planning

Long-acting reversible contraceptives (LARC) – methods of birth control that provide effective contraception for an extended period without requiring user action – include intrauterine devices (IUDs) and subdermal contraceptive implants. According to Fonda Mitchell, M.D., a gynecologist with Southeast Permanente Medical Group and clinical assistant professor at the department of obstetrics and gynecology for the GRU/UGA partnership at Medical College of Georgia, LARC have made a significant impact toward decreasing the number of teenage and unintended pregnancies.

Dr. Fonda Mitchell

“Intrauterine devices and subdermal implants have minimal side effects, can be placed in the physician’s office and can provide good contraception for three to five years,” she says. “These methods have proved very successful for our younger patients who want a reliable form of contraception that they don’t have to think about daily or for those who may not necessarily be compliant with taking medication.”

Mitchell adds that opening up a dialogue with patients provides an opportunity to educate them and help them make an informed decision about contraception and even their future.

“In our practice, most of our conversations with reproductive-age women now center around the question, ‘Are your plans to conceive this year or not to conceive this year?’” she says. “We talk about options for contraception and their ability to actively participate in family-planning goals. And we tell them [that] if their desire is to complete high school and/or college, we can offer them a contraceptive that will allow them to focus on their future. When a young woman has that conversation with her clinician, she has the opportunity to learn about all of the alternatives available to her to help ensure she achieves her goals.”

Fellowships in family planning are now available in obstetrics and gynecology programs at many medical schools around the country. Mitchell says that the additional two years of study allows residents to hone their knowledge of family-planning alternatives.

“As the millennials are completing residency training, they’re telling us that they are enhancing their fund of knowledge in the family planning arena,” she says. “They are learning more about how to counsel patients, as well as how to identify good candidates for various forms of contraception. And they are running clinics in areas that have a high-risk population for unintended pregnancy.”

 

Conflicting advice regarding pelvic exams

Two physician associations have released differing opinions when it comes to annual pelvic exams for women.

The American College of Obstetricians and Gynecologists (ACOG) recommends an annual pelvic examination for women age 21 and older as “a fundamental part of medical care,” and that it is “valuable in promoting prevention practices, recognizing risk factors for disease, identifying medical problems and establishing the clinician–patient relationship.” The exam is recommended regardless of whether the woman shows any symptoms of disease or not.

Meanwhile, the American College of Physicians (ACP) recommends against performing screening pelvic examination in asymptomatic, nonpregnant, adult women. The ACP cites harms, including overdiagnosis, overtreatment, diagnostic procedure–related harms, fear, anxiety, embarrassment, pain and discomfort as the reasons for its recommendation.

A recent study published in the American Journal of Obstetrics & Gynecology found that when women were informed that one prominent medical association recommended against the yearly exam, it substantially reduced their desire to have one.

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Urology Spotlight

Monday, June 19th, 2017

An interview with Drs. Drew Freilich, Mehrdad Alemozaffar, and John G. Pattaras

By Helen Kelley

Advancing technologies and noninvasive treatments, along with more open communication between physicians and patients, are improving the lives of people with urological conditions and diseases, from incontinence to cancer. Atlanta Medicine recently spoke with specialists who are excited to share their knowledge of the changing landscape of urology.

Minimally invasive procedures for benign prostatic hyperplasia

A growing number of older and younger adults are willing to seek out treatment for chronic conditions that have had a long-term negative impact on their quality of life, says Drew Freilich, M.D., a urologist with Urology Specialists of Atlanta.

“We’re seeing a trend of patients of all ages who are willing to be more aggressive in the treatments they want. They don’t want to continue using catheters and they are more open to accept the risks of undergoing anesthesia for procedures that can help them,” he said. “We’re also finding that cardiologists are more open to clearing older and sicker patients to go into the O.R.”

One example is men who suffer from an enlarged prostate, which causes inability to urinate and often requires them to stay catheterized and/or to take multiple medications. Freilich cites some minimally invasive procedures that are effectively reducing prostate size in cases of benign prostatic hyperplasia (BPH).

Drew Freilich, M.D

“Historically, in cases of benign prostatic hyperplasia, if the prostate grew to a certain size — over 80 grams — open surgery would be performed to remove it. Today, we use a GreenLight laser to remove prostate tissue,” he explained. “The laser technology has been around for several years now. The procedure involves inserting a small fiber into the urethra through a cystoscope and basically ‘vaporizing’ the tissue. The procedure has lower risk of bleeding than previous treatments and improves urinary flow immediately.”

Freilich says two newer procedures — UroLift and Rezūm — are also effective treatments for relieving the symptoms of BPH with minimal risks for the patient.

“UroLift is sort of a ‘glorified stapler.’ We place implants that hold the enlarged prostate tissue out of the way to relieve compression on the urethra,” Freilich said. “Rezūm is an ablation procedure that uses radiofrequency general thermal therapy, or ‘hot steam,’ to destroy the extra prostate tissue that is causing the symptoms.”

Freilich says both procedures quickly improve urinary flow and have minimal side effects.

“UroLift and Rezūm both have good long-term outcomes,” he said. “The low risks and fast recovery time make this procedure popular with both older and younger men.”

Freilich adds that a large part of his practice is comprised of people who have finally sought help after suffering long-term from conditions such as BPH, urinary incontinence and erectile dysfunction.

“Many of them don’t know there is help for their conditions or have been too embarrassed to bring it up,” he said. “As physicians, we must be more proactive about having open discussions so that patients will understand there are options available to them that can improve their quality of life.”

Robotics improve cancer treatments

“Almost every case I’ve done this week has used a scope,” says John G. Pattaras, M.D., Associate Professor of Urology at the Emory University School of Medicine and Chief of Emory Urology services at Emory Saint Joseph’s Hospital. Pattaras, who started the laparoscopic and robotic urologic surgery at Emory 17 years ago, adds that technology has evolved to make a wide variety of surgeries — including those for kidney, prostate and bladder cancers — more effective.

John G. Pattaras, M.D

“Robotics allow us to see better inside the patient. It’s not just diagnostic; it’s changed our ability to do reconstructive surgery,” he said.

Pattaras says that robotic surgery has made treatment of kidney cancer, in particular, more successful.

“In the last several years, we have seen mounting evidence that if we could remove the cancerous tumor from the kidney and spare the organ itself, the patient has a longer life expectancy. For certain size and stage tumors, removing the kidney itself has equal outcomes as far as cancer control. But this is not a good option for people who have only one kidney,” he said. “Robotic surgery gives us the precision to remove tumors, curing the cancer while preventing further deterioration of the kidney.”

For prostate cancer, the surgery that has employed robotics for years, improvements have also occurred as the technology has evolved.

“This is a very compact operation, with a complex reconstruction process to restore urination and erectile function. The robot became popular about 10 years ago as an alternative to open surgery for prostate cancer,” Pattaras said. “With today’s technology, we are able to do bigger surgeries with the same number of small holes and we’re managing more aggressive cancer. Robotics allow less invasive, lower morbidity surgeries.”

New methods for detecting and treating cancer

Mehrdad Alemozaffar, M.D

Mehrdad Alemozaffar, M.D., urologic oncology surgeon and Assistant Professor of Urology, Emory School of Medicine, says there are several recent technologies that now allow urologists to more easily detect and successfully treat various cancers.

“Bladder cancer is a good example of how a new technology is helping us locate and treat cancers more effectively. Sometimes we have difficulty finding tumors in the bladder because they can be very small and might not be readily seen using a standard cystoscope,” he said. “But we now have blue light cystoscopy, which is an enhanced imaging procedure that increases our ability to detect cancers that might be missed under regular light. It involves injecting a fluorescent agent into the bladder an hour before the procedure. The blue light cystoscope then picks up areas where the fluorescence has been taken up, which is preferentially cancerous cells.”

Alemozaffar cites another technology, targeted biopsies, as a very important tool in diagnosing prostate cancer.

“When a patient comes in with an elevated PSA (prostate-specific antigen) level, the only way we can truly diagnose cancer is with a biopsy. Traditionally the way we have done that is to take tissue samples from 12 different areas of the prostate in a somewhat ‘blind’ method,” he said. “Today, we have the ability to target actual lesions seen on an MRI. The MRI determines the probability of cancer using the prostate imaging reporting and data system (PI-RADS). We are then able to see inside the prostate using a combination of the MRI and ultrasound imaging and can zoom in on the targeted area to obtain a much more precise biopsy.”

Alemozaffar adds that the targeted biopsy, which allows him to see three-dimensional images of the prostate lesions, has been a game changer for detecting prostate cancer.

“I’m able to find more clinically significant cancers using this technology than I did in the past with the blind sampling biopsy,” he said.

Fluciclovine PET/CT improves radiotherapy targeting for recurrent prostate cancer

A clinical investigation article in the March 2017 issue of the Journal of Nuclear Medicine demonstrates that the PET radiotracer fluciclovine (fluorine-18; F-18) can help guide and monitor targeted treatment for recurrent prostate cancer, allowing for individualized, targeted therapy.

“This is the first study of its kind demonstrating changes in post-surgery radiotherapy target design with advanced molecular imaging in recurrent prostate cancer, with no demonstrated increase in early radiotherapy side effects,” explains Ashesh B. Jani, M.D., of the Winship Cancer Institute of Emory University.

According to the American Cancer Society, one in seven men will develop prostate cancer in his lifetime. In 2017, more than 161,000 new cases of prostate cancer are expected to be diagnosed in the U.S., and about 26,730 deaths from the disease are anticipated.

For the study, 96 patients were enrolled in a clinical trial of radiotherapy for recurrent prostate cancer after prostatectomy. All patients underwent initial treatment planning based on results from conventional abdominopelvic imaging (CT or MRI). Forty-five of the patients then underwent treatment-planning modification (better defining the tumor-targeted area) after additionally undergoing abdominopelvic F-18-fluciclovine PET/CT. No increase in toxicity was observed with this process.

The Emory researchers determined that the inclusion of F-18-fluciclovine PET information in the treatment planning process leads to significant differences in target volumes (the areas to receive radiotherapy). It did result in a higher radiation dose delivered to the penile bulb, but no significant differences in bladder or rectal radiation dose or in acute genitourinary or gastrointestinal toxicity.

These are preliminary results in a three-year study, which hypothesizes that there will be an increase in disease-free survival for patients in the F-18-fluciclovine-modified treatment group over those in the standard treatment group.

This study could have implications beyond prostate cancer. Jani points out, “Our methodology is readily applicable to other novel imaging agents, and it may potentially facilitate improvement of cancer control outcomes.”

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Diabetic Retinopathy Update

Monday, June 19th, 2017

By Paul Walia, M.D. of Georgia Retina

Diabetic retinopathy affects nearly one-third of all patients with diabetes and is the leading cause of visual impairment and blindness in working-aged adults. The Centers for Disease Prevention and Control (CDC) estimates that currently the healthcare costs associated with the treatment for diabetic retinopathy is around $500 million annually. Projections forecast that from 2010 to 2050, the number of Americans with diabetic retinopathy is expected to nearly double, from 7.7 million to 14.6 million, mirroring trends with obesity and metabolic syndrome.

Diabetic retinopathy often begins without symptoms. It invariably affects both eyes and is usually symmetric. If asymmetric disease is present with one eye having severe changes and the other eye not showing manifestation, the ophthalmologist must be alerted to unilateral hypoperfusion, specifically carotid artery insufficiency or blockage.

Patients may have relatively good and even perfect vision at initial presentation. However as the disease progresses, patients may experience distortion of vision, floaters and decrease of vision from mild diminution to total loss of vision.

The pathophysiology of diabetic retinopathy is complex. Hyperglycemia induces vascular pericyte deficiency, which leads to an increased vascular permeability and leakage and release of pro-inflammatory cytokines. This leads to local ischemia. Clinically, increased vascular permeability is most evident as microaneurysms, cotton-wool spots, intraretinal hemorrhages, the presence of exudates and macular edema. Ischemia is discernible as the presence of neovascularization.

Figure 1: Macular Edema

The two sight-threatening consequences are diabetic macular edema and proliferative diabetic retinopathy.  Diabetic macular edema (Figure 1) affects the macula, and thus the central vision is reduced. Focal laser treatment to photocoagulate the leaking microaneurysms has long been proven an effective therapy. Advances in pharmacotherapy have allowed intravitreal injections of medication to revolutionize the treatment paradigm. (See Figure 2.)

Medications such as anti-VEGF monoclonal antibodies and corticosteroids are vital tools in the retina specialists’ tool chest to treat diabetic macular edema. A challenge with these medications, however, is that they require multiple and ongoing injections at various intervals based on their pharmacokinetics. Promising research is ongoing about other drug-delivery vehicles, such as implantable biodegradable implants, that can allow sustained delivery of medication and reduce the frequency of injections. Additionally, there are several oral medications being studied that in conjunction with intravitreal injections may reduce the treatment burden.

Figure 2: Intravitreal Injection

Proliferative diabetic retinopathy is marked by the presence of neovascularization. (See Figure 3.) The new compensatory vessels that develop in response to ischemia lack structural integrity. They can burst and result in massive vitreous hemorrhage or fibrose and cause traction retinal detachments. Treatment options include intravitreal injection, pan-retinal laser photocoagulation of ischemic retina and vitrectomy to  remove vitreous hemorrhages and delaminate the tractional tissue from the retinal surface. Improvements in vitreoretinal surgery, including small-gauge incisions, improving viewing systems and enhancements to microsurgical instruments, have allowed retina surgeons to achieve superior outcomes.

While specialists who care for retinal diseases have a variety of treatment options to address diabetic retinopathy, prevention remains crucial. Early detection is essential to reducing the devastating consequences that can occur. Estimates suggest that a routine comprehensive dilated eye exam at least once a year can reduce the risk of eye disease by 54 percent to 76 percent and lead to the early detection of eye disease.

Figure 3: proliferative diabetic retinopathy

Of paramount importance in the treatment of diabetic retinopathy is the optimization of hyperglycemia. According to The Diabetes Control and Complications Trial, controlling diabetes and maintaining the HbA1c level in the 6 percent to 7 percent range can  delay the onset or substantially reduce the progression of diabetic retinopathy. Additional risk factors for progression of diabetic retinopathy include male sex, longer duration of diabetes, insulin use and higher systolic blood pressure as well as African-American or Hispanic ethnicity.

As the number of patients with diabetes escalates, all physicians taking care of diabetic patients will be faced with the challenge of managing this chronic disease. With early detection, systemic control and retinal therapeutics, ophthalmologists who focus on retinal care are prepared to handle the fight against diabetic retinopathy.

 

Note- Figures 1 and 3 are courtesy of the Wills Eye Manual.

 

References

Saaddine JB, Honeycutt AA, Narayan KM, et al. Projection of diabetic retinopathy and other major eye diseases among people with diabetes mellitus: United States, 2005–2050. Arch Ophthalmol 2008;126(12):1740–1747.

The Wills Eye Manual : Office and Emergency Room Diagnosis and Treatment of Eye Disease. Sixth Edition. Philadelphia :Lippincott, Williams, and Wilkins. 2012.

King P, Peacock I, Donnelly R. The UK Prospective Diabetes Study (UKPDS): clinical and therapeutic implications for Type 2 Diabetes. Br J Clin Pharmacol. 1999. 48: 643-8.

Nathan D. The Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Study at 30 Years: Overview. Diabetes Care. 2014. 37: 9-16

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Arrive Alive

Wednesday, May 17th, 2017

By Charles Wilmer, M.D. MAA President-elect, and Natalie Wilmer

Handheld smartphones – i.e., smartphones that the driver is able to touch while a vehicle is in motion – pose the greatest and most unprecedented form of danger ever seen on the road.

And smartphone ownership is growing. In 2011, 52 percent of drivers reported owning a smartphone, and by 2014 that number had grown to 80 percent. The greatest increases in smartphone ownership are among adults age 40 and older.[i] However, our nation’s youth are catching up, and their numbers are growing.

Distracted driving activities include things like using a cell phone, texting and eating. Using in-vehicle technologies (such as navigation systems) can also be sources of distraction. While any of these distractions can endanger the driver and others, texting while driving is especially dangerous because it combines all three types of distraction. (Text messaging requires visual, manual, and cognitive attention from the driver.)[ii]

Drivers allowed to manually operate a smartphone when driving are killing the innocent drivers next to them. When texting, the average time your eyes are off the road is five seconds. When traveling at 55 mph, that’s enough time to cover the length of a football field blindfolded.[iii] It is not surprising then that distracted drivers veer out of their lane and into oncoming traffic.

At any given daylight moment across America, approximately 660,000 drivers are using cell phones or manipulating electronic devices while driving, a number that has held steady since 2010.[iv] A quick look at YouTube shows multiple examples of the tragedies that ensue.

Distracted driving is killing more people in Georgia, every year. More than 1,559 people died on Georgia’s roads in 2016. That’s 127 more than in 2015, and 389 more than in 2014. Twenty-five percent more people died in Georgia in 2016 compared to 2014 because of distracted driving.[v]

The Georgia Department of Transportation (GDOT) found 74 percent of the above accidents were directly tied to the driver’s behavior, often texting and driving. Sixty-five percent of the accidents were also caused by the driver failing to stay in their lane. In comparison, only 39 percent of fatalities had to do with car occupants not wearing any seat belts, according to GDOT.[vi]

These fatalities do not even take into account those “non-fatalities” in distracted-driving crashes, people who are never able to live a normal life as the result. Thousands of Americans struggle with back pain caused by motor vehicle accidents due to distracted driving, many of whom were the innocent victim.

Other states are enacting laws to prevent these fatalities and life-altering injuries.

  • Talking on a handheld cellphone while driving is banned in 14 states and the District of Columbia.[vii]
  • The use of all cellphones by novice drivers is restricted in 37 states and the District of Columbia.[viii]
  • Text messaging is banned for all drivers in 46 states and the District of Columbia.[ix]

For example:[x] In 2016, the Massachusetts Senate passed a bill banning the use of handheld cellphones while driving. The bill, S.2093, requires anyone who wants to use a phone while driving to use hands-free technology to both dial a number and to talk. The bill prohibits a driver from holding a phone while talking, inputting an address into a GPS, or composing or reading an electronic message.

The fines would be $100 for a first offense, $250 for a second offense and $500 for a third offense. These are the same fines that currently exist for texting while driving. There is an exception in case of an emergency.

When comparing data from other states or countries that have a handheld device ban, the U.S. appears to have the biggest death wish when it comes to driving while using cellphones, with Europe close behind. European governments are responding to the challenge with increasing fines and jail time. In London, the fine for a first-time offense is approximately $300 dollars and 6 points – the loss of a driver’s license for a young driver.

This proposal is meant to save lives by banning the physical use of smartphones while the vehicle is being driven, not removing the use of cell phone capabilities (such as verbal communication and maps). The use of smart phones for non-physical capabilities (e.g phone calls, navigation, etc.) is still allowed via Bluetooth technology or verbal commands.

Fatalities and recklessness related to distracted driving is primarily the result of someone taking their eyes off the road to physically hold and operate a smartphone, resulting in loss of vision for the length of a football field while operating a two-ton missile. That is what needs to change. Unless there is a law in place that allows police to cite people for touching their phones while the vehicle is in operation, people will not voluntarily change what they find easy until they or a loved one are involved in a life-altering collision due to distracted driving.

Some of my patients have asked why doctors do not stand up for the safety of their patients and stop this carnage. I have come face-to-face with this issue myself. We lost one of our finest physicians this past year due to a distracted driver who ran over him while he was biking with friends. His wife lost a husband, his children lost their father, and the community lost one of their best physicians. More than 3,000 patients will be forced to find another doctor, never again to see the one they loved for so many years.

The time to act is now at hand. Let us be bold to realize our weakness with cellphones and put them down before another tragic loss of life occurs. It may just save our life or that of a loved one.

 

[i] http://www.multivu.com/players/English/7292854-state-farm-distracted-driving-survey-cellphone-use/

[ii] National Highway Traffic Safety Administration. Facts and Statistics. [cited 2016 Feb 23]; Available from: http://www.distraction.gov/stats-research-laws/facts-and-statistics.html.

[iii] https://www.vtnews.vt.edu/articles/2009/07/2009-571.html

[iv] https://crashstats.nhtsa.dot.gov/Api/Public/ViewPublication/811719

[v] http://www.dot.ga.gov/DS/SafetyOperation/DAAA – calculation done compared 1559 deaths in 2016 to 1170 deaths in 2014.

[vi] http://patch.com/georgia/alpharetta/impact-texting-driving-georgia

[vii] http://www.iihs.org/iihs/topics/laws/cellphonelaws

[viii] http://www.iihs.org/iihs/topics/laws/cellphonelaws

[ix] http://www.iihs.org/iihs/topics/laws/cellphonelaws

[x] http://www.masslive.com/politics/index.ssf/2016/01/massachusetts_senate_passes_ba.html

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What’s happening in Ophthalmology? More Than the Eye Can See.

Wednesday, May 17th, 2017

By Michael Jacobson, M.D.

Dr. Michael Jacobson

In this edition, we will explore and provide you insight into a wide range of ophthalmology topics. We will start at the front of the eye, the cornea, then delve deeper to discuss the lens and ciliary body. Lastly we’ll finish our eye edition focused on the back of the eye, the retina.

Hold tight onto this issue, as we will give you a whirlwind tour of these wide-ranging and fascinating topics that have meaning for all of us, not just our patients. After all, if you live a long life, you will invariably develop one of these problems.

We will discuss the latest and most exciting developments when it comes to refractive surgery, which gives individuals the opportunity to reduce their dependency on glasses or contact lenses. We’ve come a long way since radial keratotomy (RK) surgery of the 1980s. With the advent of newer techniques like laser-assisted in situ keratomileusis (LASIK) and photorefractive keratectomy (PRK), we now have procedures that permit more consistent, predictable and sustained results.

This field is burgeoning, and the population of people that may be good candidates for some type of refractive procedure is enlarging. Even solutions for presbyopia, or farsightedness caused by loss of elasticity of the lens of the eye that compels most of us over age 40 to turn to reading glasses, is being addressed with surgical options. The future may even be more promising and is likely to surpass the vision correction results that we obtain with LASIK and PRK.

Did you know that 3 million people in the U.S. have glaucoma and that this blinding eye disease progresses insidiously because there are usually no symptoms?? Did you know you can have glaucoma but have normal pressure?

Increased pressure in the eye leads to blindness, and eye drops are usually the first line of treatment. New drug classes, each with a unique mechanism, has led to a diversity of eye drop options that we have used for the past 3 decades without any big developments. However there is a new drug class awaiting FDA approval which you can read more about in this issue.

Compliance has been a major obstacle in treating glaucoma patients with drops. Innovative sustained drug delivery devices may lead to improved outcomes, and these are addressed.

For those in whom drops are not enough, laser therapy remains effective to increase outflow or decrease inflow, but there have not been new big breakthroughs here. A momentous advance in glaucoma treatment has been the discovery that cataract surgery lowers pressure. This has been very good news for glaucoma patients as that can sometimes be enough of a drop in pressure to make a difference.

If that is not thought to be enough pressure reduction, then the opening of the eye during cataract surgery now affords the opportunity to insert micro-incisional devices to facilitate the drainage of fluid out of the eye. Our authors have been involved in their development. Additional novel approaches in this micro-incisional surgery arena will be highlighted.

More advanced glaucoma damage requires larger scale, macro surgery. These procedures create a pathway – essentially a hole – from inside the eye to a bleb (a fluid-filled bump) on the ocular surface, and they can achieve profound pressure reduction. Alternate fluid pathways procedures continue to evolve year by year now. If patients undergo frequent eye exams as they grow older as recommended and when necessary, and we use the aforementioned treatments, we can hopefully prevent blindness from this terrible disease.

A cataract is formed as the lens of the eye becomes dense and opacified with age. Less light is able to enter the eye, causing diminished light perception, dulling of colors and blurry vision. Light becomes diffracted, resulting in glare. As the No. 1 cause of reversible vision loss worldwide, a great deal of time and effort has been spent on developing a safe, efficient and accurate surgical treatment.

The evolution of cataract surgery to become the operation it is today is one of the most interesting stories in all of medicine, and that journey is what the authors will share with you, taking you from ancient couching to incisional surgery where the entire cataract was removed.

The invention of intraocular implants allowed the “Coke bottle” glasses of your great grandparents to disappear. Techniques advanced allowing partial removal of the lens. Then ultrasonic dissolution and aspiration evolved to permit smaller and smaller incisions.

Very recently, a unique laser has enhanced and “simplified the surgical technique whereby the laser can make precise computer-designed incisions and dissolve the cataract. Incision size can be as small as 2mm (less than 1/10 inch), still large enough to remove the old cataract and insert a foldable lens implant substitute. Anesthesia has evolved from required general anesthesia to retrobulbar shots and now simply topical. That makes it infinitely safer for all patients.

While risks of surgery exist, this surgery offers very high levels of postoperative satisfaction. Astigmatism-correcting intraocular lenses (IOLs), refractive multifocal IOLs and presbyopia-correcting ones are available. Models have improved rapidly particularly over the past decade, and there is an excellent chance of finding a precise internal vision correction that makes the patient much less eyeglass-dependent. Essentially, a patient with healthy retina can request and choose crisp near vision or crisp distance vision. If that is not the desired endpoint, then there are multifocal IOL options that try to achieve a hybrid of both. The authors explain how cataract surgery of 2017 should preserve one’s active lifestyles like never before.

Diabetic retinopathy (DR) affects nearly one-third of all patients, and diabetes is the leading cause of blindness in our working-age population. This disease is epidemic, particularly here in Georgia.

A retina specialist will provide you with a succinct understanding of how this condition is managed. He emphasizes how all of us need to work collectively to get our patients motivated to not only achieve good A1c levels, but to address the other factors that accelerate this disease, particularly hyperlipidemia, hypertension and tobacco use.

All of us now know that what was considered an acceptable A1c of 8 in the past is not acceptable and the postponement of nephropathy, neuropathy and retinopathy depend on true tight control. Today he will report that compliant patients seldom end up blind, thanks to more tools in the retinal surgical tool box (small gauge surgery, improved pre-op pharmacology).

I recall during my fellowship and will never forget that one of my friends, in the midst of his neuroradiology fellowship, developed Type I diabetes mellitus. He diagnosed himself. It was ironic that he came down with this, given that his father, a professor of endocrinology, was also the president of the American Diabetes Association. Initially, he went into a deep depression concerned that he ultimately would lose the ability to read X-rays and catastrophizing how his life was doomed. Today such thinking hopefully is truly a thing of the past.

Age-related macular degeneration (AMD) is a very big deal because the aggressive forms of the disease lead to legal blindness (20/200 vision). This represents a severe handicap to our aging population who will lose the ability to drive, read or recognize faces.

Unless you are a pediatrician, you will encounter these visually handicapped patients. Now over 9 million people here in the U.S. have AMD, but 18 million people will have this condition by 2050. That is staggering! Knowing that QALY surveys find that people would rather have AIDS or advanced congestive heart failure than face the prospect of blindness, I am pleased to report that we have made great strides in managing this horrific condition, and a retinal specialist will share the good news with you and what we hope to achieve tomorrow.

No longer are ophthalmologists serving like psychiatrists trying to help these patients cope with their depression that such visual loss brings. Intravitreal injections of anti-VEGF drugs remain the standard of care for wet AMD. Yes, shots directly into the eye. Ninety percent of patients benefit, and of those, almost half experience some vision improvement. Considering 10 years ago when we relied on laser, we could only help 10 percent of patients, this is a revolutionary breakthrough. However, there is still room for improvement in AMD treatments since only the minority of patients experience significant visual gains and the treatment burden of frequent injections is high.

Breakthroughs for patients blinded by retinitis pigmentosa (RP) may include a retinal prosthetic device akin to a cochlear implant, called the Argus. In a different direction, we soon may be able to repopulate compromised/degenerated retinal cells using stem cell replacement, injected under the retina. 3-D printers using living cells placed on a substrate may even build networks of retinal cells that mimic the complex retinal hierarchal structure. Gene therapy provided by a viral vector (adeno-associated virus) has been recently used successfully in Leber’s Congenital Amaurosis (LCA), a blinding eye disease of children, and now may be modified to insert enhanced cells that may suppress natural VEGF production and allow our body to better defend against the onset of wet AMD.

As a consequence of the human genome project, each day more single-nucleotide polymorphisms (SNPs) of DNA are being investigated to find their relationship to eye disease. These discoveries will allow us to explore how we can synthesize protein inhibitors or promoters to prevent or cure disease.

Such research is robustly underway, including biotech company Spark Therapeutics, which is screening large populations to attack some rarer but devastating blinding eye disease such as choroideremia, RP and LCA. Enjoy the this eye edition.

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