Medical Advisory Board
Chief Medical Officer
HemWell MD is pleased to introduce its new technology, an electrosurgical unit FDA approved for treatment of grades 1, 2, 3 and 4 hemorrhoids, all grades of hemorrhoids. No other technology or treatment available has FDA approval for the treatment of the entire spectrum of hemorrhoid disease; those encountered by Family Practitioners, Gastroenterologists and Surgeons.
This report will very briefly discuss the extent of hemorrhoidal disease, normal and pathologic anatomy, and physiology, symptoms and commonly available treatments for symptomatic hemorrhoidal disease. We will spend a good deal of time explaining our procedure, the Hemwellectomy’s mode of action; its effectiveness and complications. In conclusion we will focus on the Risk Benefit ratio of Hemwellectomy compared to other commonly performed treatments.
Hemorrhoidal disease is the fourth leading outpatient gastrointestinal diagnosis, representing approximately 3.3 million ambulatory care visits in the US alone (1). Self-reporting of hemorrhoids in the US is 10 million per year, corresponding to 4.4% of the population with a peak prevalence between ages 45 to 65. Caucasians are affected more frequently than African Americans and higher socioeconomic status is associated with an increased prevalence of disease (2).
Despite hemorrhoids having a low impact on mortality they greatly impact a patient’s quality of life. The most common symptoms include: rectal bleeding, hemorrhoidal prolapse, pain, pruritus or any combination of these symptoms.
The exact cause of hemorrhoidal disease is poorly understood. Previously it was thought hemorrhoids were varicose veins. Today hemorrhoids are thought of as the pathologic herniation of the normal anal cushion into the rectum. The cushion is a highly vascular sinus-like structure which lies below the rectal mucosal wall. It receives blood from the terminal branches of the superior rectal artery. Venous blood drains both into the portal and systemic circulation. In patients with hemorrhoidal disease the arterial branches supplying the hemorrhoid have a significantly larger diameter with increased blood flow compared to normal. The increased blood flow likely contributes to the hemorrhoid’s development and growth (3,4). Pathologic venous dilatation is also present.
Always dietary and lifestyle changes, ointments and/or laxatives are prescribed first, however if ineffective, office procedures are usually recommended. Most commonly these procedures include rubber band ligation, sclerotherapy and infrared coagulation. Of these office procedures rubber band ligation is most commonly performed. Rubber band ligation is an extremely safe and effective procedure BUT is associated with significant side effects, including: pain, mild bleeding, vaso-vagal symptoms, slippage of the band, priapism, difficulty in urination, anal fissure, and chronic longitudinal ulcers (5); all considered minor complications. Very rarely massive bleeding, thrombosed hemorrhoids or severe rectal pain occur. Urinary retention requiring catheterization, sepsis and death have been reported (5). Rubber band ligation has a complication rate of 10-14% (5)(6). Pain lasting a week or more occurs in up to 75% of patients (7). Banding is FDA approved for grades 1, 2, and 3 hemorrhoids.
If office treatments fail to control patient’s symptoms or a grade 4 hemorrhoid is identified surgical treatment may be offered. Surgical hemorrhoidectomy is highly effective with a 90-95% success rate. All the side effects associated with rubber band ligation may occur with surgery including death, but side effects occur much more commonly following surgery. Surgery is always, 100% of the time, associated with severe rectal pain. Patients usually can return to work within 3 weeks Postoperatively the pain is so great it is usually recommended that patients make no plans for at least 1 week. For most patients, pain lasts 4-6 weeks depending on the type of surgery performed. Other common complications include bleeding, urinary retention, and infections (8).
Hemwellectomy is an exciting new FDA approved electrosurgical treatment for all grades of hemorrhoids: those usually treated in offices or operating rooms. Our surgical unit produces an extremely low energy galvanic (DC) current (<0.08 Watts of power) causing profound vasospasm, platelet activation and thrombosis within the terminal branches of the superior rectal artery thus dearterialization the hemorrhoid by electrosurgical ligation of these vessels . A complex electro-biochemical reaction within the hemorrhoid’s serum contributes to Hemwellectomy’s effectiveness. The extremely low energy utilized during Hemwellectomy, on the order of a temporary transvenus pacemaker produces very little tissue destruction, explaining why common complication following other procedures, ie. severe pain, infection, urinary retention have never been reported following Hemwellectomy.
In order to fully understand Hemwellectomy’s mode of action it is necessary to review the applicable basic chemistry and physics and how the procedure is performed. With the patient in the left lateral decubitus position a two pronged round tipped electrode is passed into the rectum and placed at the hemorrhoid’s base. This is the cathode, from which electrons leave the device and enter the patient. Electrons flow through the body toward the anode, a 2”x 4” metal plate placed below the patient’s hip. A saline soaked sponge is positioned between the patient’s skin and the metal electrode to decrease the skin’s resistance to electron flow. The force pushing the electrons from the cathode toward the anode is called Voltage (V). Hemwell’s equipment produces direct current with a very low voltage, 5V.
Water is a poor conductor of electricity unless it contains electrolytes. Extracellular fluid and blood serum are rich in electrolytes including Na+, K+, Cl-, HCO3-, Mg++, etc. These fluids present no resistance to electric current. The skin has the highest resistance to electric current. All other tissues possess a varying degree of resistance between the serum, with no resistance and the skin, with very high resistance.
The maximal current produced by Hemwell’s equipment is 16 milliAmps (mA); because the voltage and current are so low the power output is exceedingly low, less than 0.08 Watts. A TENS unit produces 100x more power than Hemwell’s electrosurgical unit. The very low current produced, does not overwhelm the serum’s ability to accommodate electron flow and no heat is produced. This is similar to electric current flowing within a metal wire, no heat is produced because there is no resistance to current flow. Electrical energy, not converted to heat, is however, transformed into chemical energy. Electrolysis, the production of hydrogen and oxygen gas as direct current is passed through electrolyte rich water (H2O). (fig. 1) Hydrogen gas collects near the cathode, the probe at the base of the hemorrhoid. OH- cannot approach the anode which lies beneath the patient’s hip and so remains in the serum in the form of OH- (fig. 1). Na+ and OH-, a strong base builds up in the serum. The serum’s homeostatic protein systems attempt to maintain the normal acid/base balance but are quickly overwhelmed. the serum becomes increasingly basic. Once the serum’s ph reaches 10 or above saponification occurs. Saponification occurs when triglycerides, in the
presence of a strong base, both in the blood are converted into glycerol and fatty acid salts (fig. 2). Saponification is the production of soap. The production of hydrogen gas and soap within the serum of the submucosal and prolapsed hemorrhoid create white bubbles which can be seen bubbling from the prolapsed hemorrhoid’s surface throughout the procedure. Once the procedure ends any residual soap is easily rinsed away.
To better understand the biologic effects of Hemwell’s galvanic (DC) current lets imagine traveling along with the electrons as they leave the cathode, (positioned in the rectum at the hemorrhoid’s base). The electrons traverse the moist mucosal wall and quickly enter the submucosal cushion. The electrons quickly spread throughout the cushion, to the prolapsed hemorrhoid, to its afferent and efferent circulation and likely beyond. This is similar to what might happen if a lightning bolt strikes sea water. A swimmer 100 feet from the strike would experience a substantial electric shock. Different then a lighting bolt, a continuous flow of electrons enter the submucosal cushion.
The smaller arterial branches and arterioles have a rich smooth muscle media, the larger vessels contain vasa vasorum with a smooth muscle media.
1. Effect on rectal mucus membrane: Moist mucosal membranes offer very little resistance. Electrons easily pass through and around the cells contained in the mucus membrane. Because resistance to flow is minimal no heat is produced. Little effects are seen on this tissue. Following Hemwellectomy examination of the hemorrhoids overlying tissue reveals an intact mucosa.
2. Effect on prolapsed and submucosal cushion, terminal branches of the superior rectal artery and venous circulation: As discussed above saponification and hydrogen gas production can be seen bubbling from the surface of the prolapsed hemorrhoid. Additionally direct current produces contraction of smooth muscle which results in profound vasospasm of the arterial circulation stopping all blood supply to the hemorrhoid effectively dearterialization the hemorrhoid. The veins and cushion contain very little smooth muscle which function mostly as structural support (9) remain open allowing blood to drain from the cushion and prolapsed hemorrhoid. Spasm in the smooth muscle of vasa vasorum stops blood flow to the larger branches of the superior rectal artery.
Prolonged profound vasospasm will activate platelets (10,11) (Fig. 3)
3. Hemwellectomy’s low current will denature serum proteins, endothelial cell membrane protein (12) and activate platelets (13). Hemwellectomy performed at 16mA for a sufficient length of time results in permanent ligation of the terminal branches of the superior hemorrhoidal artery with dearterialization of the hemorrhoid. Permanent ligation is produced as a consequence of the profound vasospasm, platelet activation and endothelial cell injury which in combination cause thrombosis of the hemorrhoid’s arterial blood supply.
If complete dearterialization occurs and the soapy residue is washed away, an intact mucosa can be seen level with the adjacent rectal wall. This confirms that Hemwellectomy does not damage rectal mucosa. At times the overlying mucosa is concave compared to the adjacent wall. This occurs when arterial flow is 100% ligated, and venous drainage, saponification and electrolysis, evacuate almost all of the serum within the prolapsed hemorrhoid and submucosal cushion. If a grade 1 or higher hemorrhoid remains following Hemwellectomy it signals incomplete arterial ligation. Over the ensuing days continued dearterialization with further hemorrhoidal regression frequently continues. The vasospasm and electro-biochemical effects occur immediately on the vasa vasorum, however the effect on large vessel arterial blood flow to the hemorrhoid is delayed because necrosis of these larger arteries occur over time. Larger vessel necrosis resulting from the ligation of their vasa vasorum further decreasing hemorrhoidal blood flow shrinking it further. We consider an asymptomatic residual grade 1 hemorrhoid a successful outcome.
4. The electrons leave the circulation passing through different tissue types, because bone and fat have a high resistance to electric current they likely pass around these tissues rather than through them. Total hip replacement with its metal components will conduct electric current well. We do not know the effects galvanic current will have on a prosthetic hip and therefore total hip replacement within the currents path is a contraindication for Hemwellectomy. While it is highly unlikely electrons will stray to the heart, we recommend cardiac monitoring throughout the procedure. An ICD, implantable cardiac defibrillator, is a relative contraindication for Hemwellectomy. Finally the electrons pass through a broad area of skin overlying the anode completing the circuit.
Hemwellectomy is by far the safest treatment available. When performed following our recommendations there is no damage to the overlying mucosa and therefore infection should not occur. No infectious complications from Hemwellectomy have been reported to our company. No significant nerve or tissue damage occurs, accept within the hemorrhoid itself, and therefore following Hemwellectomy there is usually no pain. A mild ache lasting a day or so may occur. This ache has not significantly impacted the patient’s ability to perform his/her usual activities of daily living. Pain occurs in less than 1% of cases and is resolved with a sitz bath (14). Once fully recovered from anesthesia, the patient may return to work the same day.
Dr Norman, Hemwellectomy’s inventor, published data studying a population of patients with all four grades of hemorrhoids (Grades 1, 2, 3 & 4). 12% of his patient population had recurrent disease following surgical hemorrhoidectomy. Hemwellectomy successfully treated 70-80% of all hemorrhoids with one treatment. 100% of the remaining 20-30% were successfully treated but required 2 or more treatments (14). Others groups also have reported a 100% success rate. ( New Pan African Study) We now recommend anesthesia with the application of 16mA to increase success rate and importantly for patient comfort. When following our recommendations, we expect success rates > 90% with a single treatment.
With one treatment, rubber band ligation’s success rate is 60-80% (medscape.com)(6). Up to 75% of patients experience significant pain lasting up to 1 week (7); other mild side effects occur 10-14% of the time (5)(6), serious complications, described above, are very rare, but are known to occur.
Surgical hemorrhoidectomy has a success rate of 90-95% (15) but always results in severe rectal pain lasting as long as 4-6 weeks. Infection is relatively common compared to rubber band ligation. While death is very rare it is a real and feared complication of this and all surgical procedures.
Hemwellectomy, HemWell’s electrosurgical procedure, is an exciting new FDA approved solution for all grades of hemorrhoids, grades 1-4. 16 mA administered with conscious sedation, successfully dearterializes 90% of patients with one treatment. Serious side effects have not reported and following anesthesia pain occurs in less than 1% of patients and resolves in hours. With repeated treatments success rates approaching 100% can be achieved.
Rubber band ligation is only approved for grades 1-3 hemorrhoids. Compared to rubber band ligation, Hemwellectomy is more effective, safer and less painful.
Surgical hemorrhoidectomy is only indicated if a lesser invasive procedure has failed or a grade 4 hemorrhoid is identified. Hemwellectomy, when compared to surgical hemorrhoidectomy, is far safer, vastly less painful and with repeated treatments; Hemwellectomy’s success rate is equal to or higher than surgical hemorrhoidectomy.
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