Lyme disease is a multisystem inflammatory disease caused by the spirochete Borrelia burgdorferi and transmitted by the bite of an infected Ixodes scapularis (northeastern U.S.) or Ixodes pacificus (Pacific coast, most common in Northern California) tick. The disease is characterized by stages, beginning with localized infection of the skin (erythema migrans), which may be followed by dissemination to many sites. Diagnostic testing for Lyme disease is challenging, and there is the potential for overdiagnosis and overtreatment.

Endogenous erythropoietin is a glycoprotein hematopoietic growth factor that regulates hemoglobin levels in response to changes in the blood oxygen concentration. Erythropoiesis-stimulating agents (ESAs; eg, epoetin alfa, pegylated epoetin beta, darbepoetin) are produced using recombinant DNA technologies and have pharmacologic properties similar to endogenous erythropoietin. The primary clinical use of ESAs is to treat chronic anemia.

Cannabis describes organic products (eg, cannabinoids, marijuana, hemp) that are derived from the Cannabis sativa plant. There is a wide variety of proposed benefits of cannabis, and some pharmaceutical cannabis products have received approval from the U.S. Food and Drug Administration for very specific medical indications. Most studies on medical cannabis have been conducted with pharmaceutical formulations, which can provide indirect evidence for cannabis preparations that are available through medical marijuana programs in some states. This evidence review focuses on some of the strongest evidence of medical cannabis in the treatment of chronic non-cancer pain, cancer pain, acute post-operative pain, and spasticity associated with multiple sclerosis (MS).

Postpartum depression (PPD) is a serious and debilitating condition that is characterized by a major depressive episode temporally and pathophysiologically related to pregnancy. It is similar to other forms of depression and characterized by sadness and/or anhedonia and may present with symptoms such as cognitive impairment, feelings of worthlessness or guilt, or suicidal ideation. Brexanolone is chemically similar to the endogenous hormone allopregnanolone, which is a positive allosteric modulator of GABAA (γ aminobutyric acid-ligand gated chloride channel) receptors. The level of endogenous allopregnanolone increases during pregnancy, reaches a peak during the third trimester but falls abruptly after delivery. It is hypothesized that a one-time administration of brexanolone infusion ameliorates symptoms of PPD via positive allosteric modulation of both synaptic and extrasynaptic GABAA receptors.

Migraine is a headache disorder characterized by recurrent moderate to severe headaches with associated symptoms. For individuals who experience more than 4 migraine days per month, preventive treatment may be recommended. Cluster headache is a disabling primary headache disorder that is characterized by attacks of intense headache on 1 side of the head, with associated agitation or restlessness, as well as by cranial autonomic symptoms. Treatment of acute headache is pain relief as well as a preventive therapy at the onset of a cluster episode to reduce the frequency of attacks. Evidence implicates calcitonin gene-related peptide (CGRP) in migraine and cluster headache. Monoclonal antibodies (mAbs) for the CGRP receptor and molecule have been developed for migraine and cluster headache.

The tropomyosin receptor kinase (TRK)-receptor family is encoded by the 3 neurotrophic receptor tyrosine kinase (NTRK) genes (NTRK1, NTRK2, and NTRK3) that code for 3 proteins. In healthy tissue, the TRK pathway is involved in the development and functioning of the nervous system as well as cell survival. However, NTRK gene fusions, which are rare kinase fusion events, create oncogenic proteins which activate a signaling cascade implicated in cell proliferation, survival, and angiogenesis. Both larotrectinib and entrectinib disrupt the activity of tropomyosin receptor kinase TRK proteins. However, entrectinib additionally inhibits 2 other kinases; anaplastic lymphoma kinase and proto-oncogene tyrosine-protein kinase.

Hereditary transthyretin-mediated amyloidosis (hATTR) is a rare, progressive, and fatal autosomal dominant genetic disease in which a variant in the transthyretin gene results in the production of misfolded insoluble transthyretin protein which accumulates as amyloid fibrils (i.e., amyloidosis) in multiple organs of the body such as the liver, nerves, heart, and kidneys causing disruption of organ tissue structure and function. Historically, hATTR was classified into familial amyloid polyneuropathy or familial amyloid cardiomyopathy. However, it is now recognized that most patients manifest signs and symptoms of both syndromes over the course of their disease and therefore the current clinical approach treats familial amyloid polyneuropathy and familial amyloid cardiomyopathy as 1 hereditary disease (polyneuropathy of hATTR) with a spectrum of clinical manifestations.

Buprenorphine is a partial μ-opioid agonist used to treat patients with an opioid addiction. Administered transmucosally, buprenorphine can be used with or without naloxone, which is an opioid antagonist. Though effective, a clinical strategy of using transmucosal buprenorphine is prone to nonadherence, diversion, abuse, and accidental misuse. To lower these risks and improve adherence. A buprenorphine (Probuphine) implant has been developed to provide sustained delivery of buprenorphine for up to 6 months via 4 subdermally inserted rods. Probuphine is intended as a maintenance treatment for a select subgroup of opioid-dependent patients who are clinically stable on a low dose of transmucosal buprenorphine (≤8 mg/d). These implants are inappropriate for new treatment recipients and those who do not have sustained and prolonged clinical stability while being maintained on a generic equivalent of buprenorphine.

Duchenne muscular dystrophy is an inherited disorder that results in progressive muscle weakness and loss of muscle mass, primarily affecting males. Duchenne muscular dystrophy results from non-sense or frame-shifting variant(s) in the Duchenne muscular dystrophy gene which is responsible for producing dystrophin, a cohesive protein essential for maintaining muscle support and strength. Antisense oligonucleotides are short, synthetic, single-stranded oligodeoxynucleotides that selectively bind to specific exons of the dystrophin pre-messenger RNA causing the exon to be skipped and thereby repairing the mutated reading frame resulting in production of an internally truncated, yet functional, dystrophin protein. Four antisense oligonucleotides—eteplirsen, golodirsen, viltolarsen, and casimersen have been approved by the U.S. Food and Drug Administration (FDA) for the treatment of Duchenne muscular dystrophy. Each targets a specific exon. For example, eteplirsen targets skipping of exon 51, golodirsen and viltolarsen target skipping of exon 53, and casimersen targets skipping of exon 45.

Testosterone replacement therapy is the primary treatment for androgen deficiency in men. Testosterone replacement is intended to counter the adverse effects of low testosterone levels with clinical signs and symptoms of hypogonadism. A variety of testosterone preparations are available for clinical use.

Spinal muscular atrophy is an inherited disorder caused by homozygous deletions or variants in the SMN1 gene. As a consequence of absent or low levels of survival motor neuron 1 protein, the motor neurons in the spinal cord degenerate, resulting in atrophy of the voluntary muscles of the limbs and trunk. Treatments in this review include 1) Nusinersen which is a synthetic antisense oligonucleotide designed to bind to a specific sequence in exon 7 of the SMN2 transcript causing the inclusion of exon 7 in the SMN2 transcript, leading to the production of full-length functional survival motor neuron 2 protein, which is very similar to SMN1. 2) Onasemnogene abeparvovec-xioi which is intended as a one-time gene replacement therapy designed to deliver a functional copy of the SMN1 gene to motor neuron cells of patients with spinal muscular atrophy. Because motor neurons are nondividing cells, it is postulated that once the SMN1 gene is incorporated in the cells, it would be retained over time and potentially allow for long-term, sustained survival motor neuron protein expression. 3) Risdiplam which is a once-daily self-administered oral therapy. It is a selective SMN2 splicing modifier designed to bind with specificity to SMN2 pre-mRNA to modulate SMN2 pre-mRNA splicing towards the production of full-length SMN2 mRNA.

Pertuzumab (Perjeta), a monoclonal antibody, is a human epidermal growth factor receptor 2 (HER2) antagonist. It is approved by the U.S. Food and Drug Administration (FDA) for (1) treatment of HER2-positive metastatic breast cancer in combination with trastuzumab and docetaxel (2) as neoadjuvant treatment of HER2-positive locally advanced, inflammatory, or early-stage breast cancer in combination with trastuzumab and chemotherapy and (3) as adjuvant treatment of HER2-positive early breast cancer at high risk of recurrence in combination with trastuzumab and chemotherapy. The combination of 2 HER2-active agents targeting different subdomains of HER2 (pertuzumab targets subdomain II and trastuzumab targets subdomain IV) may provide a more comprehensive blockade of the HER2 protein and its pathways and, thus, may lead to greater treatment effect.

Ado-trastuzumab emtansine, also known as trastuzumab-DM1 (T-DM1), is an antibody-drug conjugate that links the human epidermal growth factor receptor 2 (HER2) antagonist activity of trastuzumab to the cytotoxic activity of emtansine (DM1). The HER2 antagonist is intended as a treatment for patients with HER2-overexpressing breast cancers, and it may have applications for other HER2-positive malignancies.

The medication vandetanib is an inhibitor of the "tyrosine kinase" which is selectively targeted to RET proto oncogene, blocking VEGFR (Vascular Endothelial Growth Factor Receptor) and EGFR (Epidermal Growth Factor Receptor), preventing the progression and angiogenesis. Caprelsa is a kinase inhibitor indicated for symptomatic or progressive medullary thyroid cancer in patients 18 years of age or older, with unresectable locally advanced or metastatic disease. Caprelsa should not be used in patients with hypocalcemia, hypokalemia, hypomagnesemia, or congenital long QT syndrome. Hypocalcemia, hypokalemia, and/or hypomagnesemia must be corrected prior to Caprelsa administration and should be periodically monitored. The Risk Evaluation and Mitigation Strategy (REMS) program for Caprelsa is required by the FDA Off label indication; Non-Small Cell Lung Cancer ; Patient’s tumor is confirmed to have RET gene rearrangements <a id="

From the decade of 1990 the advances in molecular biology have shown new approaches to the treatment for rheumatoid arthritis and after systemic inflammatory conditions associated to autoimmunity. The main approaches include agents that: · Interfere with the function of cytokines · Inhibit the "second signal" required for the activation of the T cells · Deplete the T cells T (Th) cells secrete specific cytokines that in turn influence or perpetuate systemic inflammation. Th cells and their cytokines can be divided in two subgroups, called Th1 and Th2. The cytokines generated by Th1 or Th2 inhibit the cellular function of the other phenotype, for example, Interlukin 10, a cytokine segregated by Th2 inhibits the cellular function of Th1 and interferon gamma and Interlukin 12 produced by Th1 inhibit the proliferation of Th2 cells. Many of the biological therapies that have been developed aim to lower pro-inflammatory response of Th1 or increase the anti-inflammatory production of Th2 cytokine. The Th1 lymphocytes participate in a wide variety of inflammatory processes such as rheumatoid arthritis, psoriasis, psoriatic arthritis, rejection of grafts, and others. The pro-inflammatory mediators produced by Th1cells include: · Interlukin (IL)-12 · Interferon gamma · TNF · IL-15 · IL-9 · IL-10 · Il-13 The Th2 lymphocytes stimulate the production of antibodies by the B cells and increase the eosinophilic response. Activation of Th2 cells contributes to the development of chronic rejection, systemic erythematosus lupus and systemic sclerosis. The mediators produced by Th2 cells include: · IL-4 · IL-5 · IL-9 · IL-10 · IL-13 The tumor necrosis factor (TNF) and Interleukin-1 beta (IL-1) are two cytokines that intervene in the pathogenesis of rheumatoid arthritis and other chronic inflammatory conditions. When they are secreted by the synovial macrophages, TNF and IL-1 stimulate the proliferation of the synovial cells and the production of collagenase inducing the degradation of the cartilage, the resorption of the bone and inhibits the repair of the cartilage. TNF and IL_1 induce the molecular expression of cell adhesion resulting in intensification and release of additional cytokines such as IL-6, additional IL-1 and metabolites of arachidonic acid. The TNF inhibitors have been approved by FDA for the treatment of some rheumatic diseases. Abatacept (CTLA4-Ig) is a protein of soluble fusion that is formed by the Antigen 4 of the lymphocytes T and by the portion Fc of IgG1 that prevents or decreases the arthritis associated to the collagen. <a id="

Bevacizumab is a humanized monoclonal antibody directed against Vascular Endothelial Growth Factor A (VEGF-A). Vascular Endothelial Growth Factors (VEGF) and their receptors (VEGF-R) contribute to the tumor growth and to the metastasis through the promotion of the angiogenesis. <a id="

Monoclonal antibodies targeted to cancer-associated antigens have been approved by the U.S. Food and Drug Administration (FDA) for various uses in oncology. In some cases, these agents are used in settings outside of the approved label (ie, off-label use). This evidence review is limited to 3 CD20 antigen-directed monoclonal antibodies (rituximab, ofatumumab, and obinutuzumab) used for patients with non-Hodgkin lymphoma. Ibritumomab (Zevalin), which combines a CD20-directed antibody with a radioactive agent, and monoclonal antibodies that target other antigens besides CD20, are not addressed here.

Pulmonary hypertension (PH) is a chronic, progressive condition characterized by abnormally high pulmonary vascular pressure. Advanced therapies for PH are specialty medications intended to alter the natural history of the disease. These medications have been approved by the U.S. Food and Drug Administration (FDA) for 2 classes of PH: pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH). Pulmonary arterial hypertension is a rare and debilitating disease associated with abnormal proliferation of smooth muscle cells in the pulmonary arterial system, causing progressive right ventricular dilation and low cardiac output. Advanced therapy medications approved for PAH can be used as single agents or in combination. Chronic thromboembolic pulmonary hypertension is characterized by residual organized thrombi obstructing the pulmonary vasculature following acute or chronic pulmonary embolism. Currently, only 1 medication, the soluble guanylate cyclase stimulator riociguat, has been FDA approved for treatment of CTEPH.

Intravenous (IV) infusion of lidocaine or ketamine has been investigated for the treatment of migraine and chronic daily headache, fibromyalgia, and chronic neuropathic pain. Chronic neuropathic pain disorders include phantom limb pain, post-herpetic neuralgia, complex regional pain syndrome, diabetic neuropathy, and pain related to stroke or spinal cord injuries. An IV infusion of ketamine has also been investigated for treatment-resistant depression and obsessive-compulsive disorder (OCD)..

In certain cancers, the human epidermal growth factor receptor 2 (HER2) gene is amplified and overexpressed. Trastuzumab (Herceptin) is a humanized monoclonal antibody that doubles as a HER2-receptor antagonist used to treat various cancers including breast and metastatic gastric or gastroesophageal junction adenocarcinoma.

OF EVIDENCE

Respiratory syncytial virus (RSV) is the most common cause of lower respiratory tract infections in children. Several factors that put certain children at a higher risk for contracting RSV have been identified: they are age (<2 years old), prematurity, chronic lung disease of prematurity (formerly known as bronchopulmonary dysplasia), congenital heart disease, immunodeficiencies, and multiple congenital anomalies. Immune prophylaxis against RSV is a preventive strategy to reduce the incidence of infection and its associated morbidity, including hospitalization, in high-risk infants.

Infliximab (Remicade®) is a tumor necrosis factor α (TNF-α) blocking agent approved by the U.S. Food and Drug Administration (FDA) for the treatment of rheumatoid arthritis, Crohn's disease, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, and ulcerative colitis. Infliximab is also being considered as an off-label treatment for systemic juvenile idiopathic arthritis, select rheumatic and autoimmune conditions, vasculitides, and nonrheumatic musculoskeletal conditions. This evidence review focuses on the off-label group of indications.

Immunoglobulins are derived from human donor plasma and used to treat an array of disorders, including primary and secondary immune deficiency states and various autoimmune and inflammatory disorders. Human immunoglobulin therapy provides a broad spectrum of opsonizing and neutralizing immunoglobulin G antibodies against a wide variety of bacterial and viral antigens. This evidence review addresses the use of human immunoglobulin therapy for preventing and/or treating disorders in inpatient and outpatient settings. Both intravenous immunoglobulin (IVIG) infusion and subcutaneous immunoglobulin (SCIG) infusion are addressed. However, the review only considers nonspecific pooled preparations of IVIG; it does not consider other preparations used for passive immunization to specific antigens.

The use of blood-derived growth factors, including recombinant platelet-derived growth factors (PDGFs) and platelet-rich plasma (PRP), has been suggested as a treatment for wounds or other miscellaneous non-orthopedic conditions, including but not limited to, diabetic ulcers, pressure ulcers, venous stasis ulcers, and surgical and traumatic wounds.

Recombinant human growth hormone (GH) is approved by the U.S. Food and Drug Administration (FDA) for various indications and is also proposed for various off-label indications, such as cystic fibrosis and treatment of older adults without documented growth hormone deficiency (GHD). This evidence review will focus specifically on various off-label indications to evaluate the net health outcome when human growth hormone is used compared with the standard therapy for these conditions.

Botulinum is a family of toxins produced by the anaerobic organism Clostridia botulinum. Multiple formulations of botulinum toxin have been approved by the U.S. Food and Drug Administration (FDA). Labeled indications of these agents differ. Botulinum toxin products are also used for a range of off-label indications. The scope of the evidence review is limited to off-label use of 5 botulinum toxin agents currently available and approved by the FDA for medical use. These include onabotulinumtoxinA (Botox), abobotulinumtoxinA (Dysport), incobotulinumtoxinA (Xeomin), rimabotulinumtoxinB (Myobloc), and daxibotulinumtoxinA (Daxxify).

A person is considered infertile if he or she is unable to conceive or produce conception after 1 year of frequent, unprotected heterosexual sexual intercourse, or 6 months of frequent, unprotected heterosexual sexual intercourse if the female partner is over age 35 years. Alternately, a woman without a male partner may be considered infertile if she is unable to conceive or produce conception after at least 12 cycles of donor insemination (6 cycles for women aged 35 or older). <a id="

This policy addresses gender affirming surgery (also known as sex affirmation surgery, gender or sex reassignment surgery, gender or sex confirmation surgery). Gender affirming surgery is a treatment option for gender dysphoria, a condition in which a person experiences persistent incongruence between gender identity and sexual anatomy at birth. Gender affirming surgery is not an isolated intervention; it is part of a complex process involving multiple medical, psychiatric and psychologic, and surgical specialists working in conjunction with each other and the individual to achieve successful behavioral and medical outcomes. Before undertaking gender affirming surgery, medical and psychological evaluations, medical therapies and behavioral trials are undertaken to help ensure that surgery is an appropriate treatment choice for the individual. <a id="

Fetal surgery is used for specific congenital abnormalities associated with a poor postnatal prognosis. Prenatal surgery typically involves opening the gravid uterus (with a Cesarean surgical incision), surgically correcting the abnormality, and returning the fetus to the uterus and restoring uterine closure. Minimally invasive procedures through single or multiple fetoscopic port incisions are also being developed. Due to a number of factors, including the rarity of the conditions and the small number of centers specializing in fetal interventions, the evidence on fetal surgery is limited. Fetal surgery for many congenital conditions, including congenital diaphragmatic hernia (CDH) and heart defects, has not been shown to improve health outcomes compared with postnatal treatment. The available evidence is insufficient to demonstrate that fetal tracheal occlusion for CDH and fetal intervention for evolving hypoplastic left heart syndrome (HLHS) and critical pulmonary stenosis or pulmonary atresia provides improved health outcomes. For these and other applications of fetal surgery that are currently considered investigational, additional studies are needed to identify appropriate candidates and to evaluate longer term outcomes compared with postnatal management. For conditions leading to fetal hydrops (certain cases of congenital cystic adenomatoid malformation, bronchopulmonary sequestration, or sacrococcygeal teratoma), for which mortality approaches 100%, fetal surgery may be considered medically necessary. For bilateral urinary tract obstruction, evidence from retrospective and prospective cohort studies summarized in the 2011 Agency for Healthcare Research and Quality technology assessment on fetal surgery suggests that vesicoamniotic shunting improves survival, at least in the short term. A recent small, randomized controlled trial evaluating the use of vesicoamniotic shunting found limited benefit from the procedure when data were analyzed by intention-to-treat analysis. However, the study’s significant limitations, including low enrollment leading to early cessation of the study and significant crossover between treatment and control groups, make it difficult to draw firm conclusions from its findings. As such, vesicoamniotic shunting for bilateral urinary tract obstruction may also be considered medically necessary to minimize the effects of this condition on kidney and lung development. Additional studies for these surgeries are needed to better define the appropriate surgical candidates, the most effective timing of the interventions, and the long-term health outcomes in surviving children. Data from the MOMS trial showed that prenatal repair of myelomeningocele reduces the need for shunting in the first 12 months after delivery and improves a composite measure of mental and motor function, with adjustment for lesion level, at 30 months of age. Prenatal surgery also improves the degree of hindbrain herniation and the likelihood of being able to walk independently when compared with postnatal surgery. The long-term impact on function needs to be evaluated, and benefits must be balanced against risks to mother and child. Thus, fetal surgery may be considered medically necessary following informed decision making for cases of prenatal myelomeningocele that meet the criteria of the MOMS trial.

The intrauterine device (IUD) is the most commonly used method of long-acting reversible contraception because of its high efficacy, safety, ease of use, and cost effectiveness. It provides a nonsurgical option for pregnancy prevention that is as effective as surgical sterilization without the risk of surgery. The most frequently used intrauterine devices have a plastic frame and release either copper or a progestin to enhance the contraceptive action of the device. Several terms are used to describe IUDs, including IUD and intrauterine contraception; the hormonal IUD or progestin-containing device is also referred to as an intrauterine system. Types of IUDs — Two types of IUDs are available in the United States, copper containing and levonorgestrel releasing: ●Copper IUD – The copper IUD is a T-shaped device which contains 380 mm2 copper (abbreviated TCu380A, commercial name ParaGard) . It is approved by the US Food and Drug Administration (FDA) for 10 years of use. There are other copper-containing IUDs, but none are currently FDA approved for use in the United States. ●Levonorgestrel IUDs – The levonorgestrel IUDs are T-shaped devices that release levonorgestrel (LNg). There are four FDA-approved LNg IUDs available in the United States, which release a varying amount of LNg. The LNg-releasing IUDs are available in three different formulations in the United States. Four levonorgestrel IUD are FDA approved in the US: A 52 mg LNg IUD (Mierena IUD 52/5/Liletta IUD 52/5), a 19.5 mg LNg IUD (Kyleena IUD 19.5/5 ), and a 13.5 mg LNg IUD (Skyla IUD 13.5/3). <a id="

Obstetric Ultrasonography is an ultrasound examination with an instrument in real time, using transabdominal or transvaginal approach or both. Real -time ultrasonography is needed to confirm fetal vitality by observing fetal cardiac activity and fetal movement. Selecting transduce frequency is a compromise between penetration and resolution of this. Several types of tests, standard or basic, limited, and specialized (or detailed level II) these types of sonograms are performed in the second and third trimester of pregnancy. The first quarter is different and is discussed separately. <a id="

In the decade of the ‘80s, the idea of having a military ambulance in the battlefield; equipped with a robot so that a surgeon in a hospital "Mobile Army Surgical Hospital" (MASH), located many miles away could operate a wounded soldier. In this way, saves his life by preventing blood loss and other physiological damages, avoiding disasters. The National Aeronautics and Space Administration (NASA) had a similar vision, displaying a robot operating an astronaut with acute appendicitis in a space station. By 1990’s, with the advent of laparoscopic surgery, the idea that this kind of surgery could be performed using a robot was conceived. But there were severe limitations. Many anastomosis, particularly of microscopic range, could not be performed well. These instruments are rigid tools, which can only move in two planes, in, out or turning in favor or against clockwise. However, they could not duplicate the movement of the hand and wrist of the surgeon; that is, tilt or move the instruments at different angles. In 1999 it was introduced the da Vinci Surgical System, the only commercial system for gynecological surgery. In 2005, FDA gave approval for this use. The current system consists of four components: 1. A console where the surgeon sits watches a screen and controls the instruments through digital potholders and pedals. 2. The cart with three or four arms that grip interactive ranging trocars the patient. 3. A vision system in three dimensions. 4. A computerized system algorithms that converts the movement of the fingers and hands of the surgeon to the trocars within the patient's abdomen. The potential advantages of this system are: improved depth perception in three dimensions, elimination of tremor, tele potential use in surgery, shorter hospital stays and less blood loss. The disadvantages are: high cost (more than one million dollars) in the initial acquisition of equipment, increased operating time, loss of tactile sensitivity surgeon, inability to reposition the patient, space occupied by the robot, difficult to maneuver the wizard and difficulty to train residents. Applications of robotic surgery are developing rapidly, but experience with this technology is very limited at present. <a id="

Preterm birth is the leading cause of neonatal morbidity and mortality, and effective primary preventive interventions have remained elusive. In recent years, there has been renewed interest in the use of progesterone (injectable and intravaginal formulations) to prevent preterm birth.

Pelvic congestion syndrome is characterized by chronic pelvic pain that is often aggravated by standing; diagnostic criteria for this condition are not clearly defined. Endovascular occlusion (eg, embolization, sclerotherapy) of the ovarian and internal iliac veins has been proposed as a treatment for individuals who fail medical therapy.

Various minimally invasive treatments for uterine fibroids have been proposed as alternatives to surgery. Among these approaches are laparoscopic ,percutaneous, and transcervical techniques to induce myolysis, which includes radiofrequency ablation (RFA), laser and bipolar needles, cryomyolysis, and magnetic resonance imaging-guided laser ablation.

The home uterine activity monitor (HUAM) is a device that can be worn by pregnant women and is intended to detect preterm labor early. There is a substantial evidence base on home uterine activity monitoring for reducing preterm birth in high-risk pregnant women. Numerous RCTs have been performed prior to the year 2000. The trials that were the largest in size and highest in quality have not reported a benefit for HUAM, and systematic reviews of the available trials have not concluded that health outcomes are improved. The available evidence suggests that HUAM does not improve health outcomes, and HUAM is not recommended by national organizations. Thus, home uterine activity monitoring can be considered not medically necessary. <a id="

In humans as well as in animals, the fetal heart rate pattern, activity level, and degree of fetal muscle tone are sensitive to hypoxemia and acidemia. Various techniques such as cardiotocography, real-time ultrasonography, and maternal perception help to identify a fetus that is sub optimally oxygenated, with a significant degree of placental or acidemia dysfunction. These techniques allow us to intervene and prevent a progressive acidosis from ending in stillbirth. The "Non- Stress Test" (NST) is one of the fetal well-being evaluation tests used during the prenatal period. • This test uses the fetal heart rate (FHR), at which its baseline, accelerations, combined (15 beats in 15 seconds), associated with fetal movements or auditory stimulation, as well as decelerations associated with uterine contractions are evaluated. . Fetal biophysical profile-consists of four real-time ultrasonographic observations where the following are evaluated: • Fetal respiratory movements- one movement or more than 30 seconds in a 30-minute period • Fetal movements- three or more body or limb movements in a 30-minute period • Fetal tone- one or more episodes of extension with return to flexion of a limb or opening and closing of a hand • Determination of amniotic fluid volume. <a id="

Digital health technologies is a broad term that includes categories such as mobile health, health information technology, wearable devices, telehealth and telemedicine, and personalized medicine. These technologies span a wide range of uses, from applications in general wellness to applications as a medical device, and include technologies intended for use as a medical product, in a medical product, as companion diagnostics, or as an adjunct to other medical products (devices, drugs, and biologics). The scope of this review includes only those digital technologies that are intended to be used for therapeutic application and meet the following 3 criteria: 1) Must meet the definition of "Software as a medical device" which states that software is intended to be used for a medical purpose, without being part of a hardware medical device or software that stores or transmits medical information. 2) Must have received marketing clearance or approval by the U.S. Food and Drug Administration (FDA) either through the de novo premarket process or 510(k) process or pre-market approval and 3) Must be prescribed by a healthcare provider. This review will assess whether digital therapy in the form of a computer game can improve attention in children with ADHD.

The World Health Organization defines substance use disorder as “the harmful or hazardous use of psychoactive substances”, which include alcohol, cocaine, marijuana, stimulants, benzodiazepines and opiates. Treatments for drug addiction include behavioral counseling and skills training, which can be given as part of a cognitive-behavioral approach. The first prescription mobile app, developed to supplement or replace individual or group therapy, delivers a cognitive-behavioral approach developed specifically for substance use disorder in a series of interactive lessons.

Patients with attention-deficit/hyperactivity disorder (ADHD) may have alterations in their brain wave patterns that can be measured by quantitative electroencephalography (EEG). A commercially available system, the Neuropsychiatric EEG-based ADHD Assessment Aid, measures the resting theta/beta ratio of the electroencephalogram. This technology is being evaluated to aid in the diagnosis of ADHD in adolescents and children for whom there is a clinical suspicion of ADHD. Quantitative EEG is also being evaluated to aid in the diagnosis of other disorders such as in individuals with cognitive impairment (eg, dementia) and autism spectrum disorder. This evidence review does not address the use of quantitative EEG in epilepsy or emergent intraoperative settings.

Home psychiatric services are those psychiatric, psychological or psychotherapeutic services rendered by a licensed professional to a patient restricted to his home or residence. These services are considered for payment when the patient has a psychiatric or psychological condition for which leaving his place of residence is psychologically or medically contraindicated. These services include therapies in the home as well as emergency consultations. <a id="

Psychiatric evaluation Psychiatric evaluation is the method by which the physician establishes a diagnosis of mental disorder and plan an intervention. In this assesment the physician investigates the symptoms of the person consulting and the factors that contribute to their emergence and maintenance, which can be briefly classified as psychological, social and somatic. This evaluation of the disorders uses a multiaxial system with base in several axes (I-II-III-IV-V) each one of which refers to a different information domain and that can help the physician to raise the treatment and to foresee the clinical evolution. Namely the axes are: I- Clinical disorders II- Personality disorders III- General physical states IV- Psychosocial problems V- Global Function Evaluation The central objective of a psychiatric evaluation should be: Establish a diagnosis Evaluate its severity and risk Evaluate the causes Establish a management plan Estimate a prognosis The integrated psychiatric evaluation has the form of a semi-structured interview with the patient and often with their family and closest friends and complemented by a general medical history, past medical and psychiatric history, use of controlled substances history, psychosocial and sociocultural history, occupational and military history, legal history, systems review, physical and mental examination, basic laboratory analysis and chest X-rays. Psychotherapy Psychotherapy is the treatment of mental illness and conduct disorders where the physician and other qualified healthcare professionals using a specified therapeutic communication, attempt to relieve emotional disturbances, revert or change deviant behavior patterns and promote the development and growth of the personality. Psychiatric documentation must include sufficient data justifying the medical necessity of the encounter, and enough information (history and examination) that leads to the diagnosis and treatment plan. The notes must show specific therapeutic interventions, how they are applied and treatment strategy. This documentation is essential to demonstrate the quality of service and good use. The documentation of an iteration plan is indispensable with short, medium and long term objectives. Evaluation and Management (E/M) The evaluation and management (E/M) services are documented and coded according to the nature of the problem that they present and the key components in the service. These components include clinical history, physical examination, and medical decision making, considering the complexity and/or severity of the situation. They must contain sufficient information to justify medical necessity and what is appropriate of the treatment. It also includes counseling and coordination of care. Notes of E/M must be kept separate from those of psychotherapy, but on the same record, for purposes of future audits. Counseling Counseling includes one or more of the following: · Discussion of studies results, impressions or recommendations of diagnostic studies · Prognosis · Risks and benefits of treatment options · Instructions related to the management of patient, and treatment options · Reduction of risk factors · Education of patient and his relatives Crisis Psychotherapy in a crisis situation is an urgent evaluation of the history that led to the situation, the mental state of the patient and the disposition of the case. The treatment includes psychotherapy, mobilization of resources necessary to resolve the crisis, restore the safety and implement the psychotherapeutic interventions necessary to minimize the potential psychological trauma. The problem usually represents a threat to the life and requires immediate attention. <a id="

The description of codes 90785-90840 contemplates the treatment of a mental condition or behavioral disturbance. In these the clinician establishes a professional contact (face to face) through therapeutic communication with the patient. The purpose is to alleviate, change or reverse patterns of misbehavior-adapted and encourage the growth and development of personality. <a id="

The diagnosis of congenital hearing loss was previously made at an average age of 13 months for infants with severe to profound bilateral loss (SNHL) and at 17 months for those with mild to moderate loss. Children with hearing loss show delayed language development, learning and speech. This lag exists or becomes evident at the age of 3, but the consequences can be lifelong, leading to inadequate reading ability, poor school performance, unemployment, or poor job opportunity. Between 50% to 75% of children with moderate to profound bilateral deafness (SNHL) have one or more specific risk factors. Until recently, programs in the E.U. They focused on identifying and screening high-risk populations. However, these programs failed to identify the high-risk population, the questionnaire was not administered, or the follow-up of already identified populations was lost. In addition, affected children who do not show risk factors are not diagnosed. Currently, two types of tests are performed: otoacoustic emissions (OAE) and auditory brain stem response (ABR). Most screening programs have two stages: 1. Repeat OAE twice 2. Perform an OAE and then ABR or the ABR repeated twice. The results are sensitive to the following factors: · Team · Staff training · Quality control Single stage screening with ABR or OAE can detect between 80% to 95% of the affected cases. The protocol with OAE and ABE was more specific than the test of ABR or AOE performed alone. In low-risk populations, there are more false positives than positives true. About 6.7% of infants in the general population not diagnosed at the hospital they were eventually diagnosed with bilateral deafness (SNHL). In the population of low risk only 2% were not diagnosed in the hospital, but their diagnosis was carried out out eventually too. In those children not evaluated in the hospital, it is recommended that the test be carried out between 2 to 8 weeks after the discharge date. Positive results to these tests are subsequently validated by consultation otolaryngology and audiology, ABR, or other electrophysiology tests (as early as as the age of 3 months). Audiometry with visual reinforcement can be performed effectively at the age of 8 to 9 months. There are no prospective controlled studies that directly demonstrate proportionally, that the neonatal screening intervention and early intervention result in increased language development, learning, etc. In the low-risk population there are around 25% to 50% of false positives for each case of actual hearing loss. In many cases the diagnosis audiological was incorrect (7%), and eventually the infants demonstrated hearing normal when reexamined at four and 10 months. <a id="

Peripheral nerve stimulation (PNS) is a percutaneous system consisting of leads, electrodes, and a pulse transmitter that delivers electrical impulses to peripheral nerves. Leads are placed using ultrasound guidance and can be placed for temporary or permanent use in an outpatient procedure.

Neuropsychology is defined as the study (knowledge, evaluation and modification) of the brain-behavior relationship. Neuropsychology seeks to understand how the brain, through the neural network, produces and controls the behavior and mental processes including emotions, personality, thinking, learning, memory, focus, problem solving and knowledge. This discipline tries to identify the biological reasons for the behavior. Among other purposes, it seeks to clarify how diseased or damaged brain structures alter behavior and interfere with the mental process and cognitive functions. The neuropsychological tests try to measure the deficit in cognitive function and the behavioral capacity that can result from brain damage by trauma, attention deficit, exposure to toxic chemicals, alcohol, convulsive disturbances, Parkinson's disease, stroke, dementia, psychosis, etc. These tests evaluate different domain areas, namely: • orientation • memory • attention / concentration • perception • language • praxis • calculation • visuoconstructive skills • visual perception • executive / adaptive functions • emotional domain These tests do not establish a diagnosis, but quantify the severity of the alteration of certain intellectual activities. The diagnosis must always be made based on the clinical history and according to the criteria of Diagnostic Statistical Manual-IV-TR (known by its acronym in English as DSM-IV-TR). <a id="

The autonomic nervous system (ANS) controls physiologic processes that are not under conscious control. Autonomic nervous system testing consists of a battery of tests intended to evaluate the integrity and function of the ANS. These tests are intended as adjuncts to clinical examination in the diagnosis of ANS disorders.

An electroencephalogram (EEG) is a recording of electrical current potentials spontaneously from nerve cells in the brain onto the skull. Variations in wave characteristics correlate with neurological conditions and are used to diagnose conditions. EEGs can be transmitted by telephone in which electrical brain activity is recorded and transmitted to an off-site center for interpretation and report or by radio or cable in the diagnosis of complex seizure variants which require inpatient monitoring, but do not require the patient to be in bed. EEGs can be recorded by 24-hour ambulatory cassette. Twenty-four-hour ambulatory cassette-recorded EEGs offer the ability to record the EEG on a long-term, outpatient basis. Electrodes for at least 4 recording channels are secured on the patient. The cassette recorder is attached to the patient’s waist or on a shoulder harness. Recorded electrical activity is analyzed by playback through an audio amplifier system and video monitor. Electroencephalographic video monitoring is the simultaneous recording of the EEG and video monitoring of patient behavior. This allows for the correlation of ictal and interictal electrical events with demonstrated or recorded seizure symptomology. This type of monitoring allows the patient’s face or entire body to be displayed on a video screen. <a id="

It is the technological method of acquiring and recording the electroencephalogram without the use of paper. Through the use of computers, the EEG waves are recorded and stored in a format digital, which, when projected on a screen, appears again in the form of waves, the preparations and details during the recording of the track are identical to those in the studio conventional. ▪ Advantages o Allows the horizontal and vertical amplification of the recording or segment of the itself and thus increases the flexibility of reading. o Allows, through a computer network, access to traces stored in remote locations. o Does not use paper ▪ Disadvantages o Some loss of detail may occur particularly in the "settings" of lowest sensitivity

Evoked potentials are somatosensory stimuli, Visual and/or auditory. The same, when applied activate corresponding anatomical areas, resulting in a cortical potential. Latency, duration, and amplitude of the responses reflect the physiological integrity of the sensory pathways examined. <a id="

Repetitive nerve stimulation (RNS) and single-fiber electromyography (SFEMG) are important confirmatory tests for the diagnosis of disorders of the nicotinic neuromuscular junction, particularly for myasthenia gravis, Lambert-Eaton myasthenic syndrome (LEMS), and botulism. Repetitive nerve stimulation – Repetitive nerve stimulation (RNS) represents a modification of conventional motor nerve conduction studies. The interval between repeated motor nerve stimulations is designed to maximally stress the neuromuscular junction safety factor. (See 'Repetitive nerve stimulation' above.) •Slow RNS – Slow rates of RNS (1 to 5 Hz) deplete the number of quanta of acetylcholine available for release with subsequent depolarizations. In pathologic states where the safety factor for neuromuscular junction transmission is considerably reduced, some muscle fibers will fail to depolarize in the later stimuli of a train and the compound muscle action potential (CMAP) amplitude will drop, which is referred to as a decremental response (waveform 1). A reproducible decrement of >10 percent is considered abnormal in most muscles. •Rapid RNS – In disorders of the presynaptic terminal of the neuromuscular junction, where the number of released vesicles is markedly reduced, voluntary maximal isometric muscle contraction or high-frequency RNS can markedly increase the release of acetylcholine and thus enlarge the size of the resultant CMAP amplitude and area, which is referred to as an incremental response (waveform 2). <a id="

Obstructive sleep apnea (OSA) syndrome is characterized by repetitive episodes of upper airway obstruction due to the collapse of the upper airway during sleep. Conventional medical management of OSA includes weight loss, avoidance of stimulants, body position adjustment, oral appliances, and use of continuous positive airway pressure (CPAP) during sleep. Novel treatments include nasal expiratory positive airway pressure (EPAP) and oral pressure therapy.

Respiratory failure is characterized by low arterial blood oxygen (hypoxemia, PaO2) and/or high arterial carbon dioxide (hypercapnia, PaCO2 >45 mmHg). Chronic respiratory insufficiency or failure can occur with chronic obstructive pulmonary disease (COPD), thoracic restrictive disorders, and hypoventilation syndromes, and may result in poor quality of life, sleepiness, hospital admission, intubation, and death. Non-invasive positive airway pressure ventilation (NPPV) including continuous positive airway pressure (CPAP), bilevel positive airway pressure (BPAP), and home mechanical ventilators (HMV) that are pressure, rate and volume targeted are proposed for the treatment of COPD and other forms of chronic hypoventilation.

Obstructive sleep apnea (OSA) syndrome is characterized by repetitive episodes of upper airway obstruction due to the collapse of the upper airway during sleep. Polysomnography and portable sleep apnea testing (with sensors for respiratory effort, airflow, and oxygen saturation, or alternatively with peripheral arterial tone [PAT], actigraphy, and oxygen saturation) are established methods for diagnosing OSA. Other proposed methods of diagnosing OSA include limited channel home sleep monitors.

Pulse oximetry is a non-invasive way to measure oxygen levels in the blood. It may be used in a home, office or medical facility setting to monitor the health of people with certain medical conditions that can affect their blood oxygen levels. A pulse oximeter is a device that attaches to the fingertip or earlobe and uses wavelengths of light to measure blood oxygen levels and heart rate. Continuous pulse oximetry measures oxygen levels for longer periods of time (1 hour or more). Pulse oximetry provides estimates of arterial oxyhemoglobin saturation (SaO2) by utilizing selected wavelengths of light to noninvasively determine the saturation of oxyhemoglobin (SpO2). An oximeter can be used to monitor and manage patients who require ventilator support, and patients with chronic lung disease (e.g. bronchopulmonary dysplasia, chronic obstructive pulmonary disease). An oximeter is also used by various health care personnel as an assessment tool. <a id="

Chronic Obstructive Pulmonary Disease, or COPD, is a condition caused by damage to the airways or other parts of the lung. This damage leads to inflammation and other problems that block airflow and make it hard to breathe. COPD refers to wo main conditions: Emphysema and Chronic (long term) bronchitis. The main test to diagnose COPD is spirometry. Pulmonary function tests allow physicians to evaluate the respiratory function of their patients in many clinical situations and when there are risk factors for lung disease, occupational exposures, and pulmonary toxicity. These are done with the patient breathing normally, in inspiration and forced expiration and trying to keep as much air as possible in the lung. The results of the PFTs are affected by the effort of the patient. PFTs do not provide a specific diagnosis; the results should be combined with relevant history, physical exam, and laboratory data to help reach a diagnosis. PFTs also allow physicians to quantify the severity of the pulmonary disease, follow it up over time, and assess its response to treatment. <a id="

Percutaneous electrical nerve field stimulation involves the transmission of electrical impulses to cranial nerve bundles in the ear targeting brain areas involved in processing pain. In the case of patients with irritable bowel syndrome, nerves processing pain for the abdominal region are targeted.

Skin biopsy is used to assess the density of epidermal (intraepidermal) and sweat gland (sudomotor) nerve fibers using antibodies to a marker found in peripheral nerves. This procedure is proposed as an objective measure of small fiber neuropathy by identifying a reduction in the density of nerve fibers.

Radiofrequency energy has been investigated as a minimally invasive treatment of fecal incontinence, in a procedure referred to as the Secca procedure. In this outpatient procedure using conscious sedation, radiofrequency energy is delivered to the sphincteric complex of the anal canal to create discrete thermal lesions. Over several months, these lesions heal and the tissue contracts, changing the tone of the tissue and improving continence. For individuals who have fecal incontinence who receive transanal radiofrequency treatment, the evidence includes 8 nonrandomized studies. Relevant outcomes are symptoms, change in disease status, quality of life, and treatment-related morbidity. Studies include a small number of patients, and estimates of treatment differences are very imprecise. Study follow-up periods vary and need to be considerably longer and involve larger numbers of patients to evaluate long-term outcomes properly. Three-year follow-up of a small cohort showed decrement in response over time. Multicenter randomized controlled trials with sufficient power are required to evaluate the continuing use of this procedure as an alternative to other surgical interventions, physical therapies, or as an adjunctive treatment option for fecal incontinence. The evidence is insufficient to determine the effects of the technology on health outcomes.

Transesophageal endoscopic therapies are being developed for the treatment of gastroesophageal reflux disease (GERD). A variety of procedures are being evaluated, including transesophageal (or transoral) incisionless fundoplication (TIF), application of radiofrequency energy, and injection/implantation of prosthetic devices or bulking agents.

The wireless capsule endoscopy (CE) uses a noninvasive device to visualize segments of the gastrointestinal (GI) tract. Patients swallow a capsule that records images of the intestinal mucosa as it passes through the GI tract. The capsule is collected after being excreted and images are interpreted.

Esophageal pH monitoring, using wired or wireless devices, can record the pH of the lower esophagus for a period of several days. Impedance pH monitoring measures electrical impedance in the esophagus to evaluate reflux episodes concurrent with changes in pH. These tests are used for certain clinical indications in the evaluation of gastroesophageal reflux disease (GERD).

The spontaneous regression of certain cancers (eg, melanoma) supports the idea that an affected individual's immune system can delay tumor progression and, on rare occasions, eliminate tumors altogether. These observations have led to research into various immunologic therapies designed to stimulate a person's own immune system. Adoptive immunotherapy is a method of activating lymphocytes and/or other types of cells for the treatment of cancer and other diseases. This particular type of therapy removes cells from the affected individual, processes them for a period of time, and then infuses them back into the individual. This review focuses specifically on adoptive immunotherapy using tumor-infiltrating lymphocytes in individuals with melanoma.

Surgery and radiotherapy for breast cancer can lead to lymphedema and are some of the most common causes of secondary lymphedema. Lymphedema is associated with a significant impact on quality of life, and there is no cure for lymphedema. Axillary reverse mapping, also called reverse lymphatic mapping, has been developed with the intent of sparing axillary lymph nodes and lymphatics during breast cancer surgery, minimizing disruption and potentially reducing the risk of subsequent lymphedema development.

Cytoreductive surgery (CRS) includes peritonectomy (ie, peritoneal stripping) procedures and multivisceral resections, depending on the extent of intra-abdominal tumor dissemination. Cytoreductive surgery may be followed by infusion of intraperitoneal chemotherapy with or without heating, which is intended to improve the tissue penetration of the chemotherapy. When heated, this is referred to as hyperthermic intraperitoneal chemotherapy (HIPEC). Cytoreductive surgery and HIPEC have been proposed for a number of intra-abdominal and pelvic malignancies such as pseudomyxoma peritonei and peritoneal carcinomatosis from colorectal, gastric, or endometrial cancer.

Transcatheter arterial chemoembolization (TACE) of the liver is a proposed alternative to conventional systemic or intra-arterial chemotherapy and to various nonsurgical ablative techniques to treat resectable and nonresectable tumors. Transcatheter arterial chemoembolization combines the infusion of chemotherapeutic drugs with particle embolization. Tumor ischemia secondary to the embolization raises the drug concentration compared with infusion alone, extending the retention of the chemotherapeutic agent and decreasing systemic toxicity. The liver is especially amenable to such an approach, given its distinct lobular anatomy, the existence of 2 independent blood supplies, and the ability of healthy hepatic tissue to grow and thus compensate for tissue mass lost during chemoembolization.

Hematopoietic cell transplantation (HCT) is a procedure in which hematopoietic stem cells are infused to restore bone marrow function in cancer patients who receive bone-marrow-toxic doses of drugs, with or without whole body radiotherapy. Stem cells may be obtained from the transplant recipient (autologous HCT) or harvested from a donor (allogeneic HCT). Stem cells may be harvested from bone marrow, peripheral blood, or umbilical cord blood shortly after delivery of neonates.

Hematopoietic cell transplantation (HCT) is an established treatment for certain hematologic malignancies and has been investigated for a variety of adult solid tumors. Interest continues in exploring nonmyeloablative allogeneic HCT (allo-HCT) for a graft-versus-tumor effect of donor-derived T-cells in metastatic solid tumors.

Description- Intro Therapy for germ cell tumors is generally dictated by several factors, including disease stage, tumor histology, primary site of tumor, and response to chemotherapy. Patients with unfavorable prognostic factors may be candidates for hematopoietic cell transplantation (HCT).

The use of hematopoietic cell transplantation (HCT) has been investigated to treat individuals with epithelial ovarian cancer. Hematopoietic stem cells are infused to restore bone marrow function after cytotoxic doses of chemotherapeutic agents with or without whole body radiotherapy. Stem cell transplantation to treat germ cell tumors of the ovary is considered separately in evidence review 8.01.35.

Congenital athymia is an ultra rare condition in which infants are born without a functioning thymus. The thymus is crucial for the development, selection, and maturation of T cells, which are essential in effectively fighting infection and regulating the immune system. Without a functioning thymus, children develop severe immunodeficiency, susceptible to life-threatening infections. Without adequate medical treatment and management, children with congenital athymia usually do not live past the first few years of life. Multiple genetic and syndrome disorders, mutations, and deficiencies are associated with congenital athymia. Supportive care, such as strict prevention measures, prophylactic antimicrobials, immunoglobulin replacement, and isolation have been the mainstay management of children with congenital athymia. Allogeneic processed thymus tissue-agdc (Rethymic) is a regenerative tissue-based therapy that is indicated for immune reconstitution in pediatric individuals with congenital athymia. The reengineered tissue is implanted in the thigh muscle to help a child with congenital athymia build a functioning immune system to reduce the number of potentially life-threatening infections.

Intravascular lithotripsy (IVL) delivers unfocused, circumferential, pulsatile mechanical energy to safely disrupt calcium deposits within the target lesion. The IVL catheter is guided to the target lesion and an integrated balloon is inflated to four atmospheres. Once the catheter is in place, an electrical discharge vaporizes fluid inside the balloon. This action creates a rapidly expanding and collapsing bubble, generating sonic pressure waves. The sonic pressure waves travel through soft vascular tissue, cracking the intimal and medial calcium within the vessel wall. The balloon may be used to dilate the target lesion at a low pressure to maximize luminal gain. Angioplasty is included, when performed. Coronary intravascular lithotripsy is used to prepare stenotic, calcified de novo coronary vessels for stent placement. Ultrasound waves are applied intravascularly to selectively breakup calcium deposits to aid with stent placement. The physician treats coronary artery calcification, which is known to hinder other percutaneous coronary interventions, with percutaneous transluminal coronary lithotripsy. This procedure is performed in conjunction with other percutaneous transluminal or transcatheter coronary procedures (angioplasty, atherectomy, stent placement, revascularization of bypass graft or occlusion, or thrombolysis). Following femoral or radial access and using a proprietary intravascular lithotripsy (IVL) device, the physician advances the coronary catheter to the target lesion. An integrated balloon is inflated with fluid at a low pressure to contact the arterial wall. IVL is then activated, creating a small bubble within the catheter balloon that rapidly expands and collapses, resulting in shockwaves that travel through the innermost layer of the vessel wall, where it cracks the calcium by creating microfractures.