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Potential Complications With HIFU

Every treatment options bears the face of options, alternatives, risks and potential complications

Post HIFU complications are not much different from those seen with other treatments for prostate cancer or other urologic procedures. The etiology and management of such potential complications are not any different from if they occurred on their own, independent of HIFU. They are listed below under 1) Complication, 2) Etiology 3) Management. These are separated into early complications that are more likely to occur in the first 3-6 months after HIFU, and late complications that are more likely to occur after 6 months from treatment.

To exclude the potential of such complications would be misleading and truly unconscionable by a HIFU certified physician. The following is a composite of my personal experience as the first urologist in North America to perform HIFU since 2001 and in having treated more patients then any other single urologist.

POTENTIAL EARLY COMPLICATIONS

Management of the Suprapubic (S.P.) Catheter: The S.P. catheter will serve as the drainage apparatus until spontaneous voiding is resumed. After day five post HIFU the S.P. catheter should be closed off and self-voiding trial initiated. The patient should attempt voiding on his own. The S.P. tube should be opened after each voiding attempt. The patient should maintain a voiding diary documenting voided volume and post voided residual. Once the patient is voiding > 80 percent of the residual volume for 2-3 consecutive days, one can consider S.P. removal. Wound care of the S.P. tube consists of daily cleansing with soup and water and hydrogen peroxide, followed by Triple antibiotic ointment or Neosporin twice per day. Gauze with paper tape is recommended for wound coverage.

Upon removal of the S.P. catheter, the puncture site should close spontaneously within 24-48 hours. Lack of spontaneous closure may be indicative of a bladder outlet obstruction. In which case a cystoscopy should be performed to ascertain any such problems. Placement of a temporary Foley Catheter (48-72 hours) may assist in faster closure of the site. But is typically not recommended.


Urinary Retention: Immediately post HIFU:

Etiology: Urinary retention is normal in the immediate post HIFU period lasting anywhere from 7-21 days to several weeks. This is a result of edema and swelling secondary to the thermal effect from the HIFU treatment on the prostate. After HIFU, most patients will have a Percutaneous Suprapubic catheter (SP tube) with a valve that remains opened to gravity drainage in the first few days after the procedure. The catheter is closed off to drainage when the patient is to begin their voiding trial. This typically is initiated at day five after the treatment. The S.P. tube is secured within the bladder by a fluid filled balloon, as well as sutured to the skin. NOTE: There and several types of S.P. catheters. Occasionally a patient may have a standard Foley catheter instead of the SP tube. (See contraindications for S.P. catheter below)

Management: If the S.P. stops draining, check the tubing for visible kinks or blood clots and/or tissue debris. Vigorous irrigation with a catheter tip syringe may be required. If obstruction is not resolved with flushing, consider that the S.P. may have become dislodged.


Inadvertent dislodgement of Foley catheter/ Suprapubic Tube:

Etiology: Inadvertent dislodgement of the drainage catheter will most likely result in urinary retention that will require the placement of either a Foley Catheter or a new SP Tube.

Management: Catheterization in this early post HIFU period may be difficult due to edema and/or swelling. The use of a well lubricated Coude’ Tip Catheter will facilitate easier placement. In the event a urethral catheter may not be placed with ease, it is better to abandon any further attempts at transurethral placement that may cause additional urethral trauma, stricture/scar formation, or risk rectal injury. Direct visualization with flexible cystoscopy and the placement of a catheter over a guide wire is recommended as opposed to “blind instrumentation.” Urethral sounds or a catheter guide wire is absolutely contraindicated. CAUTION: The recently treated prostate with HIFU is friable and susceptible to rectal injury and potentially result in a prostatic-rectal fistula.

In order to prevent inadvertent dislodgement of Foley catheter/Suprapubic Tube, the catheter should be additionally secured to the body with either a catheter strap or silk tape. The patient should be advised to “hand hold secure” the catheter when ambulating or with any abrupt movement such as getting in and out of bed or from a sitting to standing position.


Urinary Retention after the drainage catheter has been removed:

Etiology: Urinary retention may occur at any time after the drainage catheter is been removed. The causes may be: 1) Sloughing of necrotic tissue, debris or a mucus/tissue plug. 2) Scar tissue from a urethral stricture or bladder neck contraction.

Management: In the event the tissue is not expelled, a temporary Foley catheter may be placed for 48-72 hours. This will relieve the retention, as well dislodge the tissue. Typically the patient will easily void thereafter. Cystoscopic findings in the first 3-6 months after HIFU will reveal variable debris like appearance of the ablated necrotic tissue or tissue plug. Conservative management with temporary Foley catheter placement is the recommended treatment as opposed to tissue resection (TURP), which carries a potential risk of injury to the sphincter and subsequent urinary incontinence.

The phenomenon of “tissue plug” may occur on more than one occasion during the post HIFU period, as the ablated tissue, or necrotic material, may take several months to eliminate. A mucus/tissue plug may pass on its own. In which case the patient is encouraged to drink lots of water, and take a 20-30 minutes warm sitz bath once or twice daily. It is only after more than three or more such conservative attempts that a transurethral intervention should be considered. CAUTION: During this early period after HIFU, the anatomic landmarks of the prostate may be difficult to identify, i.e.: bladder neck and veru montanum: making it riskier to cause inadvertent injury to these structures. In the event intervention is required, using the cold TURP loop one can dislodge the tissue into the bladder and irrigate it out with a catheter tip syringe.


Urethral Stricture Disease (USD):

Etiology: Urethral strictures may occur from the simple passage of a Foley catheter and/or any urethral instrumentation, and to a certain degree is common to all therapeutic modalities in the treatment of prostate cancer. Generally, urethral strictures occur as the result of injury or trauma to the urethral mucosa. In the HIFU patient, this can arise secondary to catherization and/or to infection/inflammatory process. However, it is more likely to occur as a result of HIFU energy delivered outside the prostate in the peri-prostatic tissue. The post HIFU strictures are most common at the apex. Where the tissue has a smaller diameter, and where any energy outside the prostate will result in thermal injury and devascularization of peri-prostatic fat. This is particularly true when HIFU energy is inadvertently delivered anterior and/or above the apex. This will result in necrotic avascular-scarred tissue of prostate and peri-prostatic (fatty) tissue.

The other etiology of USD may be from misdirected energy into the most distal part of the apex: either directly or inadvertently by scatter from calcifications, pre-focal heating or Brachytherapy seeds. Technical adjustment using the stacking/update software may prevent this from happening. One important precautionary measure is to pause, stack and update at twenty-five to thirty percent into the initial treatment of each zone. The significance of this is that often times the gland will swell or move toward the base. Thereby, resulting in HIFU lesions have frontage above and anterior to the apex. The response of fatty tissue is different from prostate tissue. As different types of tissue will have a difference in response due to characteristic and coefficient of absorption unique to the tissue. The union of devascularized prostate and fat leads to an extrinsic scarring onto the apex, peri-prostatic tissue and urethra itself. Similarly, to a bone in steak or bacon: the meat and the fat simply do not cook alike.

Management: The standard treatment of strictures is: 1) Urethral dilation, ideally soft dilation, with sounds reserved as a last measure) 2) Internal Optic Urethrotomy, 3) Primary Urethral-urethrostomy is rarely necessary. Most commonly, strictures can be managed by initial soft dilation, with possibly needing subsequent or intermittent self-catheterization (ISC) for a short period. An internal optic urethrotomy with a cold knife or Holmium laser with/without subsequent dilation may be necessary if conservative management fails. The use of Intermittent self catheterization (ISC) is preferred as opposed to prolonged indwelling catheter in preventing UTI’s, urethritis and risk of aggravating further stricture formation. When an indwelling catheter is required, typically 2-3 days are sufficient. Urine culture and antibiotics suppression is recommended.


Bladder Neck Contraction:

Bladder neck contraction (BNC) post HIFU may result from misdirected energy into the bladder neck; either directly or inadvertently by scatter from calcifications, pre-focal heating or Brachytherapy seeds. By maintaining the bladder full during the procedure, misdirected HIFU energy or lesion should be defused by the “heat sink” effect of the fluid filled bladder and should prevent BNC. To prevent bladder over distention, 50-100 cc’s of fluid should be drained from the SP tube between treatment zones.

Management: The initial management of the post HIFU BNC should be soft catheter dilation. If these conservative measures are unsuccessful, a standard bladder neck incision can be made at five and seven O’clock, and should release the BNC.This can be performed with either a cold knife urethrotomy, TURP of BNC or Holmium laser.


Urinary Tract Infection:

Etiology: A urinary tract infection (UTI) may occur upon the simple placement of the indwelling catheter and/or Suprapubic tube. Acquired UTI may also occur because of the prolonged indwelling catheter. Suppressive antibiotics may cause the growth of resistance bacteria and/or colonization, making for another clinical challenge. Immediately after HIFU, patients are maintained on suppressive antibiotic therapy. Ideally, a urine culture should be obtained 48-72 hours prior to removing the catheter/Suprapubic tube. The catheter/SP tube should never be removed unless there is no infection as confirmed by a negative culture. If sensitivity of a positive culture mandates a different antibiotic, the voiding efforts should be discontinued with drainage catheter placed again to gravity drainage, and not removed until the infection is resolved.

Management: An infection that occurs after the drainage catheter has been removed should be treated in the same fashion as all urinary infections as per culture and sensitivity. CAUTION: A post void residual should be performed to determined/rule out urinary retention that may promote the infection or resist antibiotic therapy. As high residual urine provide an excellent growth media for bacteria.


Epididymitis/Orchitis:

Etiology: The etiology of epididymal-orchitis is an underlying urinary tract infection that has spread to the testicles.

Management: Epididymal-orchitis should be treated with standard broad-spectrum antibiotics until definitive culture and sensitivity are available. Additional use of non-steroidal anti-inflammatory therapy may be helpful.


Gross Hematuria, Immediate versus Delayed:

Etiology: Post HIFU gross hematuria with potential clot retention may occur in the immediate post HIFU treatment as a result of inadvertent piercing a prominent vascular structure during the placement of the S.P. catheter.

Management: This may resolve with catheter irrigation and by adding water to the S.P. balloon while placing it on slight to moderate traction. Placement of a Foley catheter and establishing three-way continuous bladder irrigation may assist in resolving the problem. Cystoscopic-guided cauterization of a bleeder at the S.P tube entrance site may be necessary if conservative traction does not resolve the bleeding. Cystoscopic findings typically reveal a small venous bleeder adjacent to the S.P. puncture site.

Delayed hematuria may occur at anytime in the ensuing months after HIFU. The etiology may be from dislodgement of necrotic tissue, an isolated prostatic bed bleeder and/or hemorrhagic prostatitis. Increased fluid intake (8-10 glasses of water/day), discontinuing of any anticoagulants may resolve the problem. Otherwise, an indwelling three-way catheter may be placed in anticipation that continuous bladder irrigation will be necessary. If unresolved, cystoscopy with evacuation of clots and possible cauterization may be required. Hemorrhagic prostatitis may respond to double doses of Avodart (One or two BID)


Preventing the above Co-morbidities:

An alternative to dealing with the potential co-morbidities of necrotic debris, mucous plugs, gross hematuria, urinary tract infections and prolonged catheter time, as well as lower tract obstructive (bother/irritive) symptoms is to consider a pre-HIFU debulking procedure, such as a XPS GreenLight laser, as a preferred treatment of choice in an outpatient setting or a TURP. This will decrease the risk of all of the above co- morbidities. Additionally, by creating an empty intra-prostatic cavity will result in the normal intra-operative HIFU tissue swelling that takes place inward toward the cavity, and not outward (HIFU swelling). This will decrease the risk of normal swelling/expansion of tissue toward the base, A.P and/or lateral borders. A well-performed debulking procedure, particularly with the new XPSGreenLight laser, will also decrease HIFU operative time by allowing compression of the gland.


Rectal Injury:

The incidence of rectal injury after HIFU with the SB-500 is less than 0.3 %.

Etiology: The etiology of rectal injury may occur secondary to inadvertent energy/thermal injury into the rectum. This can occur as a direct result of High-energy on the rectum or on Denonviller’s fascia. The most susceptible areas of injury to the rectum are the two lateral borders and the apex of the prostate where the anatomy “tents” or curves. The probe can be re-positioned using the stepper to accommodate these anatomic landmarks. Rectal injury may also occur secondary to the scatter of energy bouncing off calcifications, pre-focal heating or in the presence previously placed radioactive seeds. Another form of thermal rectal injury may also occur from the accumulation of heat close to the rectal wall via a secondary medium such as feces, excess gel or lubrication. These may act as a conduit for heat accumulation.

Management: Minor rectal mucosal burns or irritation may be managed by local therapy consisting of warm sitz bath and local proctofoam-type application and high fiber/residue diet. It is not much different from local treatment of hemorrhoids or a minor rectal fissure. Although rare there is a risk of a prostatic-rectal fistula. A small fistula may be managed conservatively with urinary (catheter and/or SP tube Diversion) for 4 – 6 weeks, suppressive antibiotics, anticholinergics and a high residue fiber diet. A larger, or non-healing fistula may require a temporary colostomy and urinary diversion with eventual repair with a potential need for an anal rectal flap. However, the incidence of fistula with the Sonablate – 500 is rare and reported at < 0.3 percent. I am not aware of any fistula associated with the SB-500 that has required anything other than conservative management. In contrast, a much higher incidence of fistulas have been reported with the Ablatherm (EDAP) HIFU technology, as well as the need for surgical intervention. This is more likely due to the larger (both height and width) Ablatherm HIFU lesion. Thereby, creating a larger defect and greater likelihood for a need for more aggressive management and/or surgical intervention. Any type of blind transrectal procedure is contraindicated until after three months post HIFU. No instrumentation should be done unless under direct vision. Blind instrumentation is a high risk to a fistula or rectal injury.


POTENTIAL DELAYED POST HIFU COMPLICATIONS

The potential late complications after HIFU are similar to other treatment modalities for prostate cancer, but according to peer review medical journals occur with less frequency with HIFU.

Erectile Dysfunction:

Etiology: The etiology of erectile dysfunction in the post HIFU is similar to other therapies for localized prostate cancer: inadvertent injury to the neurovascular bundle (NVB). The injury may be as a result of direct HIFU energy on the NVB, or from secondary scatter of energy such as pre-focal heating or energy bouncing off calcifications or Brachytherapy seeds. HIFU with the Sonablate – 500 has the ability to utilize an embedded Doppler that will assist in identifying the NVB. Nonetheless, the risk of injury to the NVB is always possible.


Penile rehabilitation: as a proactive measure to decrease the risk of erectile dysfunction has demonstrated to decrease the incidence of potency, as well as decrease the incidence of penile atrophy or shortening. Which I have never seen with HIFU, but have with just about every other treatment modalities. Penile rehabilitation in the post prostate cancer treated patient consists of starting the patient on one of the PDE-5 Inhibitors (Cialis, Viagra, Levitra or Staxyn) upon removal of the catheter. Ideally, the simultaneous use of a Vacuum Constriction Device (VCD) is recommended. Restoration of blood flow is essential in “penile rehabilitation”. In the event erectile function is not returned to baseline function at 3 months post HIFU, the patient may be considered for additional medical therapy with intraurethral Muse or direct penile injection of Caverject/Tri- mix. A one-year conservative management is recommended before initiating a surgical intervention (inflatable penile implant), as most patients will return to baseline function three to 12 month – one-year mark from treatment date.


Urinary incontinence:

Etiology: The etiology of urinary incontinence in the post HIFU patient is similar to other therapies for localized prostate cancer and results from injury to the external urinary sphincter. According to peer review medical journals reports, urinary incontinence is the least often of quality of life complications associated with HIFU.

Management: The first step in evaluating urinary incontinence in the post HIFU patient is to rule out the possibility of “over flow” incontinence secondary to urinary retention. The best way to determine this is by the use of a post-void ultrasound of the bladder (bladder scan), and rule out bladder outlet obstruction by direct visual cystoscopy. The possibility of an infection must also be ruled out, as it can cause irritive symptoms, urgency and urge incontinence.

The initial treatment for urinary incontinence should be initiated with Kegel exercises along with medical therapy with one of the many drugs available for the treatment of overactive bladder or incontinence. A minimum of 1 year of conservative management is recommended before initiating a corrective surgical alternative, as most patients will regain urinary control.


Osteitis Pubica (Pubis):

Osteitis Pubica is defined as an inflammatory process of the pubic bone it is rarely associated with HIFU, and is completely preventable.

Etiology: It occurs when direct or inadvertent energy is delivered to the pubic bone. Likewise, it can occur secondary to misdirected energy “bouncing-off” calcifications, radioactive seeds or pre-focal heating. This can be prevented by continuously observing the delivery of HIFU energy, stacking, and update stacking with editing the new images as necessary. The space between the anterior capsule of the gland is minimal, (particularly in the thin patient) and consists of peri-prostatic tissue and the Dorsal Vein Complex. HIFU Treatment should never extend above and/or anterior to the anatomic capsule. Acute and severe pelvic pain is the most common clinical presentation of Osteitis Pubica. Without immediate treatment and progression, it may progress to destabilization of the pelvic anatomy, difficulties ambulating and potentially a permanent gaited walk. Diagnosis is based on the clinical history and imaging studies of a KUB, CT scan or MRI. A review of the actual HIFU case from the hard drive will document if the treatment extended into the bony structure of the pelvic bone.

Management: The clinical management of minor cases is based on physical therapy, Non- Steroidal aniti- inflammatory, and possibly direct injection of the site with steroid. In more severe cases, or if conservative therapy is unsuccessful, debridement of the affected tissue, with bone graft and or orthopedic stabilization with hardware may be required.


Post HIFU elevated PSA Nadir:

PSA has clearly been demonstrated to be prostate specific and not prostate cancer specific. Thereby, the post HIFU PSA nadir at three months is considered a surrogate value to treatment outcome. The ideal post HIFU PSA nadir should be less than 0.5 and preferably < 0.2. However, even with total whole-gland ablation of the prostate, there may remain residual in-situ prostate tissue that is capable of producing benign PSA levels. A nadir at three months post HIFU of greater than 0.5 ngm and/or three progressive nadir elevations 3 months apart should be considered as a potential residual or recurrent cancer and mandate a prostate biopsy. A PSA is recommended every three to four months post HIFU for a minimum of five years. Subsequent PSA determinations may be extended to every six months, but remains at the physician discretion. Three progressive PSA elevations is an indication for a prostate biopsy.


Contraindications for S.P. catheter

In certain situations there may be contraindications to the placement of a S.P catheter. These include a history of extensive pelvic surgery, a history of bladder cancer, obesity that precludes identification of important anatomic landmarks for safe placement of S.P. catheter. IN such cases, one can treat the anterior and middle section without a catheter. It is recommended that a Coude Foley catheter be place before initiating the treatment of the posterior zone. This will allow introduction of the catheter with greater ease.

NOTE: The above guidelines are the opinions/suggestions of The International HIFU Society (www.InternationalHIFU.com), a 501(c) 3, a not for profit organization, (established in 2001, accepted by the IRS 2004) and do not represent the views and/or opinions of any other entity.The recommendations for treatment are, and should be tailored to the individual patient and remain at the discretion of the treating physician.

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