What is the mechanism of action of IVL?
Due to its unique mechanism of action, our IVL technology cracks both medial and intimal calcium while minimizing trauma to the vessel wall. If playback doesn't begin shortly, try restarting your device.
Should adjunctive IVL be used before definitive intravascular stenting for celiac stenting?
In a case-report, Cheng and colleagues (2021) presented the novel use of adjunctive IVL before definitive intravascular stenting of a heavily calcified celiac artery ostial occlusion. This case entailed a 79-year old woman who presented with chronic post-prandial abdominal pain and weight loss.
Is intravascular lithotripsy a feasible therapeutic option for calcified femoro-popliteal lesions?
Recently, intravascular lithotripsy of calcified lesions at the femoro-popliteal segment with the Shockwave balloon was introduced as a feasible therapeutic option for these complex lesions. The authors also described the Tack Endovascular System, the first-of-its-type, for the repair of post-angioplasty dissections.
Can femoro-popliteal lesions be treated with endovascular interventions for peripheral artery disease?
Giannopoulos and Armstrong (2019) noted that femoro-popliteal lesions account for a significant proportion of endovascular interventions for peripheral artery disease (PAD). These investigators reviewed the literature on the application of newly approved devices in the treatment of atherosclerotic lesions at this segment.
What is IVL treatment?
Intravascular lithotripsy (IVL) is a novel technique based on an established treatment strategy for renal calculi, in which multiple lithotripsy emitters mounted on a traditional catheter platform deliver localized pulsatile sonic pressure waves to circumferentially modify vascular calcium.
When should I take IVL?
Indications for Use— The Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave C2 Coronary IVL Catheter is indicated for lithotripsy-enabled, low-pressure balloon dilatation of severely calcified, stenotic de novo coronary arteries prior to stenting.
What is the approach value for coronary intravascular lithotripsy?
New FY22 Code: Coronary Intravascular Lithotripsy (IVL)Body PartApproachDevice0 Coronary Artery, One Artery 1 Coronary Artery, Two Arteries 2 Coronary Artery, Three Arteries 3 Coronary Artery, Four or More Arteries3 PercutaneousZ No DeviceJun 22, 2021
What does shock wave medical do?
Shockwave is an acoustic wave which carries high energy to painful spots and myoskeletal tissues with subacute, subchronic and chronic conditions. The energy promotes regeneration and reparative processes of the bones, tendons and other soft tissues.
How do you use IVL?
0:342:57Shockwave Intravascular Lithotripsy (IVL) System, Mechanism of Action ...YouTubeStart of suggested clipEnd of suggested clipIn a standard technique the ivl catheter is advanced and placed at the lesion using marker bandsMoreIn a standard technique the ivl catheter is advanced and placed at the lesion using marker bands under angiography. With the integrated balloon expanded to sub nominal pressure of 4 atmospheres.
What is Shockwave IVL?
The Shockwave C2 Coronary IVL Catheter is used before implanting a stent, to open the arteries that supply blood to the heart (coronary arteries) that are narrowed or blocked due to calcification.
What is a calcified coronary lesion?
Coronary calcification occurs when calcium builds up in the plaque found in the walls of the coronary arteries, which supply blood to the heart muscle. The presence of coronary calcification can be an early sign of coronary artery disease, which can cause a heart attack.
How often can you have shockwave therapy?
Most patients require three sessions of shockwave therapy, each a week apart, before significant pain relief is noticed. Some conditions may require five treatments. Your specialist will be able to discuss your particular case and expectations with you.
Who should not get shockwave therapy?
Malignant tumors, metastasis, multiple myeloma, and lymphoma in the treatment area have to be seen as contraindications for treatment with radial and focused shock waves with low and high energy. Cancer itself, in the form of the underlying disease, is not a contraindication for ESWT [4].
What is the difference between shockwave therapy and ultrasound therapy?
While a sound wave/ultrasound can be described as the ripples (sinusoidal waves) created when a small rock is dropped in water, a shock wave is faster and not as smooth. Due to their high intensity and faster nature, the shock waves look more similar to the V-shaped bow wave of a boat.
What every physician needs to know
Intravascular large B-cell lymphoma (IVLBCL) is a rare form of an extranodal malignant non-Hodgkin lymphoma (NHL) that involves the growth of lymphoma cells within the lumina of capillaries, small arteries and small veins which plug these vessels. The diagnosis is characteristically established on extranodal tissue.
Are you sure your patient has intravascular large B-cell lymphoma? What should you expect to find?
The diagnosis is established by a tissue biopsy incorporating immunohistochemical stains or flow cytometry. The biopsy demonstrates malignant cells in the lumens of small or intermediate blood vessel walls. There should be minimal extravascular involvement.
Beware of other conditions that can mimic intravascular large B-cell lymphoma
This lymphoproliferative disorder is one of the real masqueraders in lymphoma.
Which individuals are most at risk for developing intravascular large B-cell lymphoma
There are no known risk factors for the development of this particular lymphoma.
What laboratory studies should you order to help make the diagnosis and how should you interpret the results?
The diagnosis is established with a tissue biopsy, which demonstrates the malignant cells in the lumens of small or intermediate vessel walls. Immunohistochemical staining confirms the diagnosis. IVLBCL is CD20 positive and is accompanied by monoclonal kappa or lambda light chain restriction.
What imaging studies (if any) will be helpful in making or excluding the diagnosis of intravascular large B-cell lymphoma?
Contrasted whole-brain magnetic resonance imaging (MRI) of the head and contrasted total-body computed tomography (CT) of the chest, abdomen, and pelvis or FDG-positron emission tomography (PET) scanning with CT fusion are utilized recommended in the diagnosis and staging of this disorder.
If you decide the patient has intravascular large B-cell lymphoma, what therapies should you initiate immediately?
The therapy is dependent upon the histologic subtype of the lymphoma and the sites of involvement.
What is IVL in medical terms?
IVL is a rare aggressive systemic B-cell lymphoma which over time can obstruct arterial blood flow to distal locations causing ischemia in various organs and subsequently systemic symptoms, neurological deficits or both . This study population consisted of 654 patients with IVL spanning over five decades. The aim of this study was to document the spectrum of clinical symptoms and their respective frequencies to help create a clinical framework for the prompt diagnosis of IVL. The majority of cases showed neurological symptoms (52 % of patients in this study). Of the patients presenting with neurological symptoms, the most common presentation was cognitive impairment/dementia (60.9 %). Paralysis (22.1 %) and seizures (13.4 %) were the second and third most common neurological presentations which were seen more frequently than stroke-like presentations (7.8 %). We did not find significant differences between Asian and non-Asian populations in regard to time from initial symptoms to death, overall survival or type of treatment. Due to the rarity of this tumor and lack of sensitive diagnostic methods, it is difficult to diagnose IVL in a timely fashion and therefore proper understanding of the disease presentation will allow early diagnosis and prompt intervention. Due to the findings in this study, we conclude that when a patient presents with rapidly progressive neurological manifestations or neurological manifestations that cannot be explained, IVL should be suspected. At a minimum, we hope that our analysis will serve as a basis for future prospective studies of CNS IVL.
How many cases of IVL were published?
A comprehensive meta-analysis of 654 cases of IVL published between 1957 and 2012 was performed to provide better insight into the neurological presentations of this disease. Neurologic complications were mainly divided into central nervous system (CNS) and peripheral nervous system (PNS) presentations.
What is intravascular lymphoma?
Intravascular lymphoma (IVL) is a rare , aggressive systemic B-cell lymphoma first described by Pfleger and Tappeiner in 1959 [ 1 ]. IVL has an estimated annual incidence of 0.5 cases per 1,000,000 population [ 2 ]. The disease is characterized by selective growth of lymphoma cells within the lumina of vessels, particularly small- and medium-sized blood vessels [ 3 ]. The unique tropism of these cells to those sites is due to the absence of CD29 and CD54 surface ligands, which may possibly limit the ability to cross the endothelium. Proliferations of large lymphoma cells within the lumen of small- to medium-sized vessels are usually observed [ 3 ]. Over time, these tumor foci may obstruct the arterial blood supply to the distal locations causing ischemia in various organs, resulting in systemic symptoms, neurological deficits, or both.
Is IVL a neurological disease?
Patients with intravascular lymphoma (IVL) frequently have neurological signs and symptoms. Prompt diagnosis and treatment is therefore crucial for their survival. However, the spectrum of neurological presentations and their respective frequencies have not been adequately characterized. Our aim is to document the spectrum of clinical symptoms and their respective frequencies and to create a clinical framework for the prompt diagnosis of IVL.
Policy
Aetna considers mechanical or laser peripheral atherectomy (atheroablation) medically necessary in members who meet all of the following criteria:
Background
Atherectomy was introduced in 1985 to improve upon the limitations of balloon angioplasty, primarily, abrupt reclosure and restenosis. Atherectomy devices cut and remove atherosclerotic plaque from a vessel wall or grind the atheroma into small particles, allowing them to embolize distally.
The above policy is based on the following references
Adams G, Shammas N, Mangalmurti S, et al. Intravascular Lithotripsy for Treatment of Calcified Lower Extremity Arterial Stenosis: Initial Analysis of the Disrupt PAD III Study. J Endovasc Ther. 2020;27 (3):473-480.
What Is It?
- The Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter consists of the Shockwave C2 Coronary IVL Catheter, IVL Connector Cable, and IVL Generator. The catheter is a tube-like device called a balloon catheter that contains integrated lithotripsy emitters, which can break up hard m...
How Does It Work?
- The doctor delivers the catheter to the heart by making a small cut (incision) in the patient’s arm or leg. The lithotripsy emitters at the end of the catheter create pressure waves that are intended to break up the calcification that is restricting the blood flow in the vessels of the heart. This helps open the blood vessels when the balloon is inflated (angioplasty). After using the Shockwave sy…
When Is It used?
- The Shockwave C2 Coronary IVL Catheter is used before implanting a stent, to open the arteries that supply blood to the heart (coronary arteries) that are narrowed or blocked due to calcification.
What Will It Accomplish?
- The device allows for the opening of calcified arteries to allow stent implantation. In the clinical trial of 384 patients, 92% of them were able to receive the stent and survived without a heart attack or another procedure for 30 days. After one year, approximately 75% of patients had survived without a heart attack or additional procedure.
When Should It Not Be used?
- The Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave C2 Coronary IVL Catheter should not be used: 1. to deliver a stent, or 2. in vessels of the neck or brain.
Additional Information (Including Warnings, Precautions, and Adverse Events)