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Archive for the ‘Clinical’ Category

Innovations in Interventional Pulmonology

Thursday, November 30th, 2017

By Venk Lakshminarayanan, MD, Ph.D.

Traditional bronchoscopy is a procedure allowing direct visualization of the tracheobronchial trees of the airway. Historically, the main types of bronchoscopy are rigid and flexible. Flexible bronchoscopy allows for visualization of the lumen, mucosa of the trachea, proximal airways and segmental airways to the third generation of segmental bronchi.

This device allowed for focused obtainment of specimens as part of the evaluation for infectious, malignant or alternative etiologies. Additionally, it is used to diagnose or treat abnormalities within or adjacent to these airways.

Extrinsic compression of the airway from a mass can be assessed as well as direct sampling of peribronchial masses with transbronchial needle aspiration (TBNA). With the advent and initiation of fluoroscopic guidance, there was increased sensitivity in the ability to biopsy peripheral lung lesions which were not directly visualized in an airway.

Bronchoscopy has evolved greatly over the past decade with advances in endoscopic and pathological technologies. Traditional use of fiberoptic bronchoscopy limited tissue sampling to larger (> 2 cm) and more central lesions. With the development of electromagnetic navigation bronchoscopy (ENB) and radial probe ultrasound guidance, we can now access and obtain diagnostic tissue from the peripheral lung nodules with greater sensitivity and at smaller sizes.

Figure 1 - Interventional Pulmonology

Figure 1: Right lower paratracheal lymph node 4R in a patient with a right upper lobe lung mass right mediastinal lymph adenopathy. The white arrow indicates the lymph node. The blue arrow notes the lower border of the azygous vein. Samples taken by L-EBUS were consistent with non-small cell lung cancer. This was consistent with the previously biopsied right upper lobe mass.

These procedures enable the experienced interventionalist to access most mediastinal lymph nodes to provide a complete staging procedure. ENB, which combines bronchoscopy with electromagnetic navigation, allows the interventional bronchoscopist to sample significantly smaller and more peripheral lesions. The use of a linear probe EBUS (L-EBUS) allows for sampling of enlarged mediastinal, hilar lymph nodes or masses, potentially eliminating the need for mediastinoscopy. Endobronchial ultrasound-guided TBNA is a less-invasive alternative in staging of lung cancer in addition to diagnosis.

The presence of lymph node metastasis remains one of the most adverse factors for prognosis in non-small cell lung cancer (NSCLC). The presence of mediastinal lymph node involvement may indicate the presence of stage IIIA or IIIB, thereby suggesting either inoperability or the need for adjuvant chemotherapy and/or radiotherapy.1

Sampling Lymph Nodes and Peripheral Modules

There are three techniques involved in interventional pulmonology in the diagnosis, staging and treatment of potential lung cancers: endobronchial ultrasound (EBUS), electromagnetic navigational bronchoscopy (EMB) and photodynamic therapy (PDT).

Endobronchial ultrasound (EBUS) is a bronchoscopic technique that uses ultrasound to visualize structures adjacent to the wall of the bronchus. It allows for rapid pathologic staging of mediastinal and hilar lymph nodes,1 as well as for pathologic evaluation of nodal disease, which may be seen during radiographic staging.

EBUS is different than endoscopic ultrasound (EUS). While both visualize and guide sampling of lymph nodes, EBUS is performed during bronchoscopy for mediastinal lymphadenopathy. There are two types of EBUS: radial probe EBUS (RP-EBUS) and linear probe EBUS (L-EBUS). The RP-EBUS provides 360-degree circumferential images of the airway wall and surrounding structures.

Figure 2

Figure 2: Electromagnetic Navigational Bronchoscopy (ENB). Image 2A demonstrates the 3-D reconstructing virtual image of the mass following CT scan. Images 2B, 2C and 2D demonstrate the left lower lobe mass by CT imaging. Figure 2E demonstrates the ENB-generated directed pathway to the nodule.

A major advantage of RP-EBUS is its ability to visualize the layers of the airway wall in detail. In contrast, the L-EBUS provides a view that is parallel to the shaft of the bronchoscope with view 30 degrees forward of oblique. Color flow and Doppler features permit identification of vascular, ductal, and cystic structures. The major advantage of L-EBUS is its ability to guide real-time sampling. Coupled with rapid onsite evaluation (ROSE) by a cytopathologist allows for expedited pathologic staging of lymph node. Figure 1 demonstrates a right lower paratracheal lymph node (4R station) seen with an L-EBUS probe, in a patient with a peripheral lung mass with associated adenopathy.

Another area of interventional pulmonology that has rapidly developed recently is electromagnetic navigation bronchoscopy (ENB). ENB allows for more accurate targeting of peripheral lung lesions for biopsy over traditional bronchoscopy with fluoroscopy.The combined modalities of ENB and RP-EBUS can increase the sensitivity of diagnostic yields, especially with peripheral lung nodules, which is of great advantage for nodules as small as 10 mm.

Figure 2 demonstrates a left lower lobe lung nodule biopsied under ENB. Coupled with L-EBUS, this two-staged procedure allowed for diagnostic sampling of the peripheral lung mass and mediastinal lymph nodes. This allowed pathologic staging of this lung mass, and the mediastinal adenopathy results in an expedited diagnostic pathway with increased sensitivity in lung cancer staging. The goal of these combined modalities is to provide a greater patient experience and reduce time to initiate treatment.

Figure 3

Figure 3A: the initial obstructing right main-stem mass consistent with known metastatic adenocarcinoma.

Surgical resection of some early-stage tumors may be contraindicated because of concerns regarding reduced postoperative pulmonary function, ventilation or poor preoperative functional status. Up to 10 percent of patients successfully resected with lung cancer subsequently develop a second primary lung neoplasm.2

Using varying doses of low-intensity laser irradiation, cell growth functions can be stimulated or inhibited.4 One such treatment strategy used on cancer cells PDT, in which cancer cells are treated with a photosensitizer (PS) in combination with laser irradiation. Individually, they are non-toxic. However, with light-activation, reactive oxygen species are generated inducing cancer cell death.4 Cell-specific photosensitizers are in development for future cancer treatment.

Figure 4

Figure 3B: the mass following Photfrin© and first laser light treatment. The mass appears mucoid and less vascular.

After a photosensitizer is administered and the tumor is visualized, the light fiber is introduced through the working channel of the bronchoscope, and the rigid cylindrical tip of the light fiber is embedded into the lesion. This not only protects healthy mucosa from light exposure, but also delivers more energy to the tumor itself.

When the laser light is applied to the target area at the appropriate wavelength, the photosensitizer is activated, causing ROS generation that results in cancer cell death.5 A repeat bronchoscopy is planned 48 hours after the laser light exposure, when the inflammatory response is decreasing and tumor necrosis is achieved. At that time, all debris should be removed bronchoscopically.6

Figure 5

Figure 3C: the mass following the second light exposure and completion of debridement. Note that the right mainstem is patent and there is minimal scarring noted in the airway.

If a second operation may not be feasible for a patient, PDT can provide a therapeutic alternative that spares functional lung tissue required in lung cancer patients.3 Indications for PDT include treatment of micro-invasive endobronchial NSCLC in patients for whom surgery and radiotherapy are not indicated.3 Additionally, PDT can also be used to palliate symptoms in patients with completely or partially obstructing endobronchial masses due to non-small cell lung cancers.3

Figures 3A, 3B and 3C demonstrate a patient with a large right main-stem lesion recurrent NSCLC. In Figure 3A, the obstructing mass is noted in the right main-stem bronchus. Following the initial laser light therapy, the obstructing tumor was noted to have a more mucoid appearance allowing for initiating of debridement (Figure 3B). Serial light exposure and mechanical debridement allowed for local debridement of the complete obstructing mass (Figure 3C).

Interventional pulmonology is a rapidly burgeoning field providing novel and innovating, less-invasive ways of diagnosing and treating a variety of lung diseases. These are just a few of the novel diagnostic and therapeutic procedures available within the field of interventional pulmonology.


References

1. Spira A, Ettinger DS. Multidisciplinary management of lung cancer. N Engl J Med 2004; 350: 379–392

2. Chiaki E, Akira M, Akira S., et al. Results of Long-term Follow-up of Photodynamic Therapy for Roentgenographically Occult Bronchogenic Squamous Cell Carcinoma. Chest 2009; 136(2):369–375)

3. Moghissi K and K Dixon. Update on the current indications, practice and results of photodynamic therapy (PDT) in early central lung cancer (ECLC). Photodiagnosis Photodyn Ther. 2008 Mar;5(1):10-8

4. Crous, A., and H. Abrahamse: Lung cancer stem cells and low-intensity laser irradiation: a potential future therapy? Stem Cell Res Ther. 2013; 4(5):129.

5. El-Hussein A, Harith H, Abrahamse H. Assessment of DNA damage after photodynamic therapy using a metallophthalocyanine photosensitizer. International Journal of Photoenergy. 2012; 2012:1–10).

6. Edell ES, Cortese DA: Photodynamic therapy. Its use in the management of bronchogenic carcinoma. Clin Chest Med. 1995; 16(3):455).

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Managing Incidentally Identified Pulmonary Nodules

Monday, November 20th, 2017

By Robert J. Albin, MD, FCCP, FAASM

Due to the ubiquitous availability of CT scanners, coupled with the ever-increasing propensity by physicians across all specialties to order advanced imaging studies, the number of incidentally detected pulmonary nodules has been soaring.

Over a recent 7-year stretch, one large integrated health sys-tem reported a 53 percent increase in the number of CT scans ordered. This trend has resulted in more than 1.5 million newly detected lung nodules in the U.S. annually. Exactly how best to manage these nodules has become an important but prickly dilemma, at times pitting the varied and potentially conflicting perspectives of patients, practitioners, medical societies and practice guideline directives against each other.

What has emerged and become clear is that the management of pulmonary nodules should be driven by the importance of distinguishing those that are malignant from those that are not by balancing the desire to intervene quickly for malignant nodules while avoiding and limiting procedures for those that are benign. What is not clear is how best to achieve this goal.

Figure 1: Right upper lobe [RUL] andleft upper lobe [LUL] solid nodules. The RUL nodule is irregular but contains central calcification. The LUL nodule has irregular borders and is non-calcified. These lesions have remained stable on follow-up exam.

One of the first issues to resolve is to be certain that we are all speaking the same language when it comes to describing nodules. The descriptive nomenclature associated with pulmonary nodules, while endeavoring to be more precise and useful, has created an ever-expanding vocabulary of important distinctions.

Nodules may be solid, subsolid, ground-glass or contain a mixture of these components. They may be ovoid, round, smooth-bordered, spiculated or irregular. It is important to state whether they contain calcium or are non-calcified. While some nodules are detected as solitary abnormalities, in other instances, multiple nodules may be identified. Precise size measurement using proper criteria [the average of long and short diameters, both obtained on the same transverse, coronal or sagittal reconstructed images] adds to prognostic significance. Lobar localization is important, as is the presence or absence of emphysema or fibrosis. These distinctions serve the purpose of trying to identify those nodules with a less than 1 percent probability of being malignant (pCA < 1%), in order to avoid unnecessary testing and procedures.

The Fleischner Society, an international multidisciplinary medical society for thoracic radiology founded in 1969, published their latest recommendations for managing pulmonary nodules this year. Its intent was to cut down on unnecessary follow-up exams and procedures. While extremely useful and worthy of summarizing here, they are not without limitations and controversy. These guidelines apply to incidentally detected nodules in individuals at least 35 years of age.

For a single, solid, non-calcified nodule less than 6 mm in a low-risk patient, no further follow-up is recommended. Even in high-risk patients, the likelihood of this nodule being malig-nant is reported as less than 1 percent. However, suspicious morphology or upper lobe location can raise pCA to the 1 percent to 5 percent range, so a 12-month follow-up study can be considered in this subgroup of patients.

For a nodule 6-8 mm in size in a low-risk patient, a 6-12 month follow-up should suffice if stable. If high risk, additional imaging at 18-24 months should be considered. If the nodule is greater than 8 mm, PET-CT at 3 months is recommended as pCA now approaches 3 percent.

If there are multiple solid, non-calcified nodules less than 6 mm, no routine follow-up is recommended, as this typically represents healed granulomas or intrapulmonary lymph nodes. In a high-risk patient, consider a 12-month follow-up. If any nodule is greater than 6 mm, perform 3-6 month follow-up with optional follow-up at 18-24 months.

For a solitary, pure ground-glass opacity [GGO] less than 6 mm, no routine follow-up is recommended, although 2- and 4-year follow-up should be considered in selected high risk populations. If greater than 6 mm in size, 6-12 month follow-up CT is recommended and repeat imaging every 2 years through 5 years total.

For solitary part-solid nodules, no follow-up is necessary if less than 6 mm. If greater than 6 mm with the solid component less than 6 mm, obtain a follow-up scan in 3-6 months and then annually for 5 years. If greater than 6 mm with a solid component greater than 6 mm, obtain a follow-up scan at 3-6 months. For suspicious morphology or a solid component greater than 8 mm, consider PET-CT, biopsy or resection.

For multiple subsolid nodules less than 6 mm, these are likely infectious or inflammatory. If repeat imaging is stable at 3-6 months, consider scanning at 2 and 4 years. If at least one nodule is 6 mm or larger, rescan at 3-6 months. If persistent, consider multiple primary adenocarcinomas as a potential etiology.

If these recommendations seem confusing or even un-sound, take solace in knowing that you are not alone in this opinion. Unfortunately, the guidelines are based upon very low-quality evidence, as clearly stated in the Society paper. However, despite this, they are generally considered to rep-resent best practice parameters.

Additional shortcomings include the inability to accurately define “low-risk” versus “high-risk” populations. Given that the greatest recent percentage jump in the incidence of lung cancer is among never smokers, who then can be considered to be at “low risk”? Also, how can size be an absolute cutoff criterion for benign versus malignant disease? Every lung cancer was less than 6 mm at some point in its biology. In my opinion, size depends upon when, in the history of this nodule, the scan was performed. A single point in time has never been able to predict a trend.

Figure 2: Multiple bilateral ground-glass opacities of varying sizes. Biopsies have proven these to be multicentric lepidic adenocarcinomas. Management has included surgical resection as well as stereotactic body radiation therapy [SBRT].

I take these guidelines for exactly what they are – guidelines. Good clinical judgment and intuition must always weigh into the decision process. From my perspective, there is no nodule (other than a densely calcified, smooth bordered one) that does not merit additional follow-up imaging. While an extra CT(s) does add to the patient’s total radiation exposure burden, I believe the benefit outweighs the risk and so do the majority of patients.

Not surprising to me, a recent report comparing physicians’ assessment of pretest probability of whether a nodule was benign or malignant demonstrated that physicians were better at predicting malignancy than the frequently cited Mayo Clinic or VA prediction calculators. This is a very sobering finding and reaffirms the importance of clinical experience and “gut” instincts.

In the absence of strong evidence upon which to propose guidelines, the perspective and preferences of the patient and the clinician can and should play a critical role in the decision-making process. Successful management of what has now become a commonplace clinical problem depends upon shared values, concerns and frank dialogue between providers and patients.

Looking ahead, enhancing existing prediction calculators by including novel radiographic measurements, as well as analysis of exhaled, serum and bronchoscopic biomarkers, may aid in distinguishing benign from malignant disease. Until then, it might be a good idea to follow this old medical adage – what would you do if this was your mother?


References

1. Guidelines for Management of Incidental Pulmonary Nodules Detected on CT Im-ages: From the Fleischner Society 2017. Radiology 2017.

2. Iaccarino JM, Wiener RS. Pulmonary Nodule Guidelines: What Physicians do When Evidence-Based Guidelines Lack High-Quality Evidence. Chest. 2017; 152(2):232-234.

3. Physician Assessment of Pretest Probability of Malignancy and Adherence with Guidelines for Pulmonary Nodule Evaluation. Chest. 2017; 152(2):263-270.

4. Swensen SJ, Silverstein MD, Edell ES et al. Solitary Pulmonary Nodules: Clinical Prediction Model Versus Physicians. Mayo Clin Proc. 1999; 74(4):319-329

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The Emergence of Sports Cardiology

Wednesday, October 25th, 2017

The Emergence of Sports Cardiology

By Walter E. Mashman, M.D.*, Kathleen Turchin, BSN*, and Jonathan H. Kim, M.D.#

*Piedmont Heart Institute, Atlanta Georgia

#Emory University School of Medicine, Division of Cardiology, Atlanta Georgia

 

In 490 BC, after the Greek town of Marathon successfully defended Persian attack, the messenger Pheidippides is said to have run to Athens to deliver the news. Upon arrival, as he exclaimed “Nike!” (victory, win), Pheidippides collapsed and perished.

While this legendary story represents the premise for the modern-day marathon, it can also be said to lay claim to the first documented case of sudden cardiac death (SCD) in the athlete. Two millennia later, tragic cases of sudden death in athletes still garner significant and appropriate media attention and public scrutiny.

Moreover, the impact of intense exercise on cardiovascular function, cardiovascular disease, and long-term health outcomes remain controversialin certain populations of highly conditioned individuals. As elite athletes, such as Benoît Lecomte (who swam across the Atlantic Ocean and plans to swim across the Pacific Ocean next year), continue to challenge the limits of human physiology and embrace the extremes of physical performance, practitioners charged inthe cardiovascular care of athletes are challenged with providing the most appropriate and evidence-based care to these fittest of individuals.

In 2002, the World Health Organization warned that physical inactivity is a global problem associated with major causes of death and disability in the world.(1) It is well established that physical inactivity correlates with significant cardiovascular morbidity in the United States,including obesity, diabetes, and most cardiovascular diseases. Indeed, as many as 250,000 deaths per year in the United States are attributed to a lack of regular physical activity (2), and a scant few Americans achieve 30 minutes of daily physical activity.(3)

Despite the ongoing epidemic of physical inactivity and obesity present within western society, there is also an expansive growthgroupof individuals who are engaged in high levels of exercise and athletic training far beyond the recommended American Heart Association (AHA) guidelines. Perhaps best representative of this exercise “boom”are the number of individuals participating in U.S. recreational road races.

From 1990-2013, the number of road race participants rose from just over 5 million to 19 million finishers, with female runners now representing the majority of race participants. While these statistics have leveled over the last several years, the interest in fitness and recreational exercise events will likely continue to grow.

Notably, as aging recreational athletes grow in number, cardiovascular disease and risk remain present. Appreciating that the cardiovascular counseling, guidance, and clinical management of athletic patients are different compared to members of the general population represents an important tenet of sports cardiology.

Sports cardiology is generally defined as the preventive cardiovascular care for athletes. While the definition of an athlete is debatable, we choose to define an athlete broadly, as any individual who places a high premium on exercise and athletic performance. As such, competitive athletes at any level (secondary school, collegiate, professional), recreational athletes (participating in community- sponsored events or have a commitment to fitness), and athletes of all ages (youth to master) are consistent with an “athletic patient” who may seek care and counseling in the sports cardiology clinic.

The prevention of SCD in young, competitive athletes represents one of the most important mandates for the sports cardiologist. The causes of SCD during vigorous exercise in young athletes can be divided into structural etiologies (e.g. hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, congenital coronary anomalies, Marfan syndrome), primary electrical disorders (e.g. WPW, long QT syndromes, Brugada syndrome, catecholaminergic polymorphic ventricular tachycardia), and acquired cardiac abnormalities (e.g. myocarditis, commotio cordis, drugs).(5)

While it is reassuring that these events remain rare in occurrence, pre-participation cardiovascular screening represents an essential process for the athlete prior to competitive athletic training. Whether the addition of the 12-lead electrocardiogram (ECG) to the standard targeted history and physical provides additional sensitivity and leads to improved clinical outcomes remains a significant source of controversy.

In the U.S., pre-participation cardiovascular screening guidelines for competitive athletes, endorsed by the American College of Cardiology (ACC) and AHA, currently consist only of a targeted history and physical.(6) However, with recent data suggesting differential risk of SCD in specific collegiate athletic populations,(7) the uncertainty of the best evidenced-based strategy in the cardiac screening of youthful athletes persists.

While screening for occult cardiovascular disease in youthful athletes represents a point of emphasis in sports cardiology, master athletes (in general >35-40 years old) typically represent the majority of patients cared for in the sports cardiology clinic. For master athletes, occult coronary atherosclerosis underlies “the sports paradox” that has been described for many years.

Despite the established cardiovascular health benefits of exercise, there is a small transient increased risk of acute myocardial infarction or SCD during vigorous exercise. More recent data suggest that, in rare cases, extreme endurance exercise in master runners with cardiac risk factors and stable coronary disease may also precipitate a cardiac event.(8)

Additional controversies surrounding master athletes have recently arisen, including the loss of overall mortality benefit for those engaged in extreme levels of exercise, early onset atrial fibrillation, the development of arrhythmogenic and pathologic cardiac remodeling, and accelerated coronary atherosclerosis. (See Figure 1.).(9) While intriguing and provocative, it is important to recognize the limitations of the current available data. Most studies are observational and cross-sectional in nature, limited in subject numbers, and potentially confounded by the lack of carefully controlled data. It remains imperative that we emphasize the overwhelming prognostic benefit of exercise and the lack of causal evidence implicating a truly ‘pathologic’ exercise dose.

Figure 1. Controversies surrounding increased exercise dose from light/moderate to excess and possible pathologic outcomes associated with long-term exposures to strenuous levels of exercise (taken from Kim JH et al. Curr Atheroscler Rep. 2017)9

Figure 1. Controversies surrounding increased exercise dose from light/moderate to excess and possible pathologic outcomes associated with long-term exposures to strenuous levels of exercise (taken from Kim JH et al. Curr Atheroscler Rep. 2017)9

Open physician-patient dialogue and shared decision-making should guide the exercise prescription for active patients presenting with concerns or diagnosed cardiac issues. Athletes who question the safety of ultra-endurance exercise should be provided unbiased counseling based on the most recent evidence and allowed to make the best decisions that fit with medical standards of care and their own expectations and psychological well-being.

In 2011, the growth and recognition of sports cardiology led the ACC to launch its Section of Sports and Exercise Cardiology. Not surprisingly, this section was received with immediate enthusiasm, and current membership has grown to overmore than 4,000 practitioners. This strategic and important step from the ACC has catalyzed intense scientific inquiry in the field and further contributed to the development of the ACC’s annual Care of the Athletic Heart Conference. In 2014, the ACC further highlighted the emergence of sports cardiology in a State-of-the-Art paper.

Within the field of sports cardiology, there remain many important areas of uncertainty that impact the cardiovascular care provided to athletes of all ages and competitive levels. For youthful athletes, refining athletic ECG interpretations and determining the benefit of athlete ECG screening continue to represent critically important future directives.

Many unresolved controversies also exist for master athletes. Future studies will require the inclusion of “athlete-specific” risk factors, detailed phenotyping including imaging and biomarkers, and perhaps most importantly, the development of long-term master athlete registries.

In the Atlanta cardiology community, we are building programs and working with universities, professional sports teams, and rehabilitation, and local athletic organizations aimed at addressing the core tenets and directives of sports cardiology.

REFERENCES

1. Physical inactivity a leading cause of disease and disability. http://www.who.int/mediacentre/news/releases/release23/en/.

2. Myers J. Cardiology patient pages. Exercise and cardiovascular health. Circulation. 2003;107:e2-5.

3. Pucher J, Buehler R, Merom D and Bauman A. Walking and cycling in the United States, 2001-2009: evidence from the National Household Travel Surveys. Am J Public Health. 2011;101 Suppl 1:S310-7.

4. http://www.runningusa.org/statistics.

5. Chandra N, Bastiaenen R, Papadakis M and Sharma S. Sudden cardiac death in young athletes: practical challenges and diagnostic dilemmas. J Am Coll Cardiol. 2013;61:1027-40.

6. Maron BJ, Friedman RA, Kligfield P, Levine BD, Viskin S, Chaitman BR, Okin PM, Saul JP, Salberg L, Van Hare GF, Soliman EZ, Chen J, Matherne GP, Bolling SF, Mitten MJ,Caplan A, Balady GJ, Thompson PD, American Heart Association Council on Clinical C,Advocacy Coordinating C, Council on Cardiovascular Disease in the Y, Council onCardiovascular S, Anesthesia, Council onE, Prevention, Council on Functional G, Translational B, Council on Quality ofC, Outcomes R and American College of C. Assessment of the 12-lead electrocardiogram as a screening test for detection of cardiovascular disease in healthy general populations of young people (12-25 years of age): a scientific statement from the American Heart Association and the American College of Cardiology. J Am Coll Cardiol. 2014;64:1479-514.

7. Harmon KG, Asif IM, Klossner D and Drezner JA. Incidence of sudden cardiac death inNational Collegiate Athletic Association athletes. Circulation. 2011;123:1594-600.

8. Kim JH, Malhotra R, Chiampas G, d’Hemecourt P, Troyanos C, Cianca J, Smith RN, Wang TJ, Roberts WO, Thompson PD, Baggish AL and Race Associated Cardiac Arrest Event Registry Study G. Cardiac arrest during long-distance running races. N Engl J Med. 2012;366:130-40.

9. Kim JH and Baggish AL. Strenuous Exercise and Cardiovascular Disease Outcomes. Curr Atheroscler Rep. 2017;19:1.

10. Lawless CE, Olshansky B, Washington RL, Baggish AL, Daniels CJ, Lawrence SM, Sullivan RM, Kovacs RJ and Bove AA. Sports and exercise cardiology in the United States: cardiovascular specialists as members of the athlete healthcare team. J Am Coll Cardiol. 2014;63:1461-72.

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ExtraCorporal Membrane Oxygenation

Wednesday, October 25th, 2017

by Dr. Peter Barrett 

More than 40 years since it was first used in 1971, ECMO has become an integral part of treatment in the adult critical care community

Extracorporal membrane oxygenation (ECMO) is a rapidly advancing form of mechanical circulatory support. ECMO was first used in 1971 by Dr. Robert Bartlett in the neonatal population for meconium aspiration. The evolution of the technology in terms of pumps and oxygenation membranes has allowed for the adoption of this technology in the adult critical care community.

ECMO is divided into two types of support. VA-ECMO (venoarterial) support consists of draining blood from the right side of the circulation, usually from the femoral vein, and passing the blood through a membrane oxygenator, then returning the blood to the arterial side of the circulation usually via the femoral artery. This can also be done via central cannulation from the right atrium to the ascending aorta. VA-ECMO provides full support for the cardio-pulmonary system.

VV-ECMO (veno-venous) support involves draining blood from the ve-nous circulation, oxygenating it and returning the blood to the venous side of the circulation. VV-ECMO is used when there is isolated respiratory failure. This form of support depends on normal cardiac function.

Indication for VA-ECMO support include but are not limited to cardiogenic shock, septic shock where more than two vasopressors are required, massive pulmonary embolism, acute myocarditis, stunned myocardium post cardiopulmonary bypass and primary graft failure post-orthotopic heart transplant, among other causes. Most often, cannulation is performed at the bedside or in the cath lab. The procedure is performed via the percutaneous approach using the Seldinger technique.

Cannulation does require an initial bolus of heparin, so active GI bleeding or recent neuro-surgery or recent stroke are contraindications for the procedure.

VV ECMO and VA ECMO

Once the patient is on VA-ECMO support, we move rapidly to wean all vasopressors and inotropic support usually within a 4-6 hour window, but this is where an experienced team is important. We work for rapid extubation and early ambulation of these patients.

In our experience at Piedmont Atlanta Hospital, which includes 434 patients since 2009, an average time of sup-port is between 7-14 days for myocardial recovery. De-cannulation is generally performed at the bedside, but depending on circumstances may involve going to the operating room for open cut down and direct surgical repair.

VV-ECMO support involves the same percutaneous cannulation approach but does not involve arterial cannulation. Once we have established adequate oxygenation and carbon dioxide removal, we again work toward rapid ex-tubation if clinical circumstances allow. In our experience, the most common indications for VV-ECMO support are Acute Respiratory Distress Syndrome (ARDS), community-acquired pneumonia (CAP), pulmonary embolism with in-tact cardiac function, near drowning and gastric aspiration.

The time to recovery is longer in VV-ECMO support. We have maintained support up to 67 days, and centers across the country have gone out to several hundred days with lung recovery. If we cannot obtain early extubation, we move to early tracheostomy.

The main contraindication to VV-EC-MO support is an irreversible pulmonary process, for example idiopathic pulmonary fibrosis. Our experienced team of pulmonary physicians and critical care physicians work closely together to make the determination of suitability for VV-ECMO.

The Extracorporeal Life Support Organization (ELSO) maintains the largest database on volumes, outcomes and quality for ECMO support in the world. The volume, outcomes and quality of the ECMO program at Piedmont Atlanta Hospital has earned it a Gold designation from ELSO. The most recent data from 2016 bear this out.

ECMO is a rapidly advancing form of mechanical circulatory support that is used for either cardiopulmonary sup-port or respiratory support. It has a steep learning curve, therefore the benefits of an experienced team of ECMO specialists is invaluable in obtaining excellent quality outcomes.

PAH Outcomes 2016

Program Recognition

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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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