HIFU Expert: George M. Suarez, MD, FACS, FA AP

Known as one of the world’s leading experts and practitioners in HIFU, Dr. Suarez has performed over 2,000 HIFU procedures and has personally trained more than 400 doctors in this life-changing technology. Dr. Suarez is a Board certified urologist who practices in Miami, Florida, and is a former faculty member of the University of Miami department of Urology. Dr. Suarez completed his training in general surgery at Northwestern University in Chicago, Illinois, and his urology residency and fellowship at Tulane University School of Medicine in New Orleans, Louisiana. Dr. Suarez is Co-Founder and former Medical Director of SonaCare Medical, where he played an instrumental role in the development of their HIFU technology and in the design of FDA trials. He is trained in both Sonablate and Ablatherm, the two HIFU technologies that are now FDA approved. Dr. Suarez is also the Medical Director for HIFU facilities in George Town, Cayman and the Dominican Republic. He has received numerous awards including the S.E.S American Urology Association’s prestigious Montague Boyd award for excellence in research. More information on Dr. Suarez and his practice can be found at www.HIFUmedicalexpert.com.



Suarez180Q: When and how did you first get interested in HIFU for the prostate?
I learned about HIFU via a European Urologic Association meeting about 15 years ago. I immediately became very interested and very excited about it since it was the only treatment I had seen that was non-invasive, preserved quality of life, and was extremely effective with regard to eradicating the cancer and achieving long-term results. Soon after, back in 2003, I placed the very first HIFU machine in the Americas – in the Dominican Republic specifically – and for the first two years I was the only US urologist practicing HIFU. It was a lonely time. Medicine outside the US is not as averse to accepting new technologies of course, and medical tourism was the only option for Americans seeking HIFU for the prostate. I started training other physicians and eventually opened HIFU centers in Mexico, Canada, South America, Europe and the Caribbean as well. In the last 13 years I’ve personally performed more HIFU procedures than any other physician.

Q: What is it like to use the technology? Do you have a preferred method or system?
I initially trained on the Sonablate device, but I am also fully trained on the Ablatherm device and they’re both excellent. The bottom line is that HIFU offers oncologic outcomes that are equivalent to any of the standard therapies such as surgery and radiation. But more importantly, it offers a procedure that preserves quality of life issues like impotence and urinary incontinence. In this regard, the rates of preserving these functions are exceedingly higher than any other therapy option. The “focused” in “focused ultrasound” of course means that it treats the targeted tissue without emitting energy to the surrounding healthy tissues. It is based on a computer-assisted, image-guided process that human hands simply cannot do. You’re essentially taking a scalpel out of the surgeon’s hand and you’re putting a computer image-guided therapy in place that is more precise than human skill is capable of. However, HIFU, similar to operating any medical device, is operator-dependent and in the hands of an experienced physician it will result in great outcomes. However just like an airplane or automobile, in the hands of improperly trained or novice operator, it’s more like “anything can happen.” I say this not to sound negative, but to emphasize the importance of proper training and experience.

Q: Please describe the current nature and scope of any focused ultrasound research for treating the prostate that you are involved in.
I am looking into adjunct immunotherapy in combination with HIFU as it relates to enhancing tumoricidal effect of the combined therapies.

Q: How important is the FDA approval of HIFU for the ablation of prostate tissue?
The approval of HIFU by the FDA is enormously important for American men, as it offers an alternative treatment that has fewer incidences of complications. Moreover, Americans will no longer need to travel outside the country for treatment, and quite honestly, I too am happy to no longer need to travel to perform treatments. However, I am fortunate to have had the opportunity to bring awareness of this technology to the US, and it’s certainly rewarding to have been a part of the process. Interestingly, and unbeknownst to most people, none of the existing prostate therapies have FDA approval. Instead they are accepted as “Grand-fathered approved” prior to the FDA sanctioning medical devices. If these treatments were to undergo the rigors of an FDA trial, one can’t help but wonder if they would receive approval.

Q: Why did the FDA take so long to approve HIFU?
We, as well as the FDA, had many challenges designing the clinical trial. Initially the FDA recommended we compare HIFU to Cryosurgery. However, we were not able to enroll patients in the Cryo arm. They then suggested possibly Brachytherapy. This too did not work out either for SonaCare or for EDAP. SonaCare ended up doing the trial in radiation salvage patients and EDAP bypassed a comparative arm altogether. Incidentally, HIFU treatment in the post-radiated patient is more challenging than in a primary newly diagnosed patient. But suffice it to say both companies struggled with enrollment. Additionally, by the time it came to present to the FDA panel, there had been many modifications by the AUA on the importance of Gleason 6, and if it merits treatment versus watchful waiting. The panel also expressed some concerns about complications, and this is why I place such emphasizes on training, experience and operator dependent issue. With proper training and experience, HIFU related complications are few if not rare.

Q: Where do you think HIFU should fit in the treatment of prostate cancer?
Undoubtedly HIFU is the optimal treatment for men diagnosed with prostate cancer. As a man and a urologist, I know I would choose HIFU over any other therapy. When it comes to prostate cancer I see many, many unhappy patients who have previously been treated with surgery or radiation, but very few who are unhappy men who’ve been treated with HIFU. I might add that there are also numerous evolving applications for the technology for the treatment of other medical conditions that are being explored by researchers around the world. Without a doubt, I think the future of many medical and surgical treatments, beyond prostate cancer, will be replaced by some form of application related to energy derived ablative technology similar to HIFU. The concept holds an incredible future for medical care.

 

Q: Are all prostate cancer patients candidates for HIFU?
Absolutely not! The qualifications for the ideal HIFU candidate are no different than those men be considering other treatments for localized prostate cancer. There are some considerations that must be taken into consideration such as: prostate volume, history of rectal injury, surgery or fistula. In patients with prior urologic intervention, a cystoscopy exam is recommended.

Q: Please describe the status of focal therapy for men with prostate cancer, in terms of your research and the general trends in the field right now.
I am a believer in focal therapy but only under the strict criteria that include MRI image-guided biopsy and saturated number of biopsies. Without a doubt prostate cancer has undergone a very critical paradigm shift in both diagnosing and treating it. Focal or targeted HIFU therapy continues to gain acceptance and has become part of the mainstream of treatment options. There are some very similarities to breast cancer in that focal HIFU has become the “Male Lumpectomy” for prostate cancer. Within the alternatives of focal therapy, HIFU is the most precise in that there is no propagation or scatter of energy beyond the target region with the precision of lesions that are 1 cm in height and 3 cm in weight.

Q: What are the questions a patient should ask a potential doctor or operator to determine if HIFU is the best choice?
This is a great question, and there are a number of key factors. The ideal candidate has organ confined prostate cancer and falls into the strata of low to median risks of recurrence with reference to PSA and Gleason score. However, unlike many that reference HIFU as a procedure reserved for non-surgical candidates, this is far from the truth. In addition to the clinical staging, the ideal candidate is the patient who wishes to preserve his dignity, quality of life and lifestyle as it refers to erectile function and urinary control. It also includes someone who wants to undergo a non-invasive, painless outpatient treatment that can allow him to return to full function and lifestyle in less than 24 hours. We have all heard about potency sparring surgery and men having immediate post op recovery of their erections, however, these outcomes are limited to the skills of few urologic surgeons. HIFU, by being a computer/image-guided modality has limited need for intuitive surgical skills.

Q: What kind of complications can men undergoing HIFU expect?
The most common complication after HIFU is urinary retention. This is as a result of swelling and edema of the prostate secondary to heating of the tissue. Additional complications are no different than those commonly experienced in other prostate cancer treatment modalities. However, with HIFU there is a significantly lower incidence of compromise of quality of life issues. A review of my personal ten-year outcome data revealed the following: erectile dysfunction, 2%; urinary incontinence, 0.4%; urethral stricture, 2%; urinary tract infection, 2%; urinary retention, 100%; post-HIFU average number of days with catheter, 3 days with pre-HIFU TURP performed and 10-21 days with no TURP performed.

In my experience the incidence of complications equates to the length of catheter time. Therefore, I routinely recommend a PRE-HIFU TURP. This is not the standard debulking TURP, but more intended to create a channeling effect that will reduce the length of catheter time.

Q: What are the clinical statistics regarding HIFU success?
I think that cure rates should be stratified in intervals of time by benchmarks of five-, ten- and fifteen-year intervals. There are numerous peer review articles that have reported fifteen-year statistics and outcomes comparable to other treatments. Due to my position as Co-Founder and Medical Director of SonaCare, I voluntarily held back from publishing any of my personal outcomes so as not to be perceived as conflict of interest. But there is sufficient data to substantiate HIFU as a viable alternative for the treatment of prostate cancer.

Q: How do you envision HIFU evolving in the mainstream of prostate cancer treatments?
The fact that thousands of men sought HIFU as their treatment of choice, which required them to pay for their treatment and travel outside the country to be treated by a procedure that was not FDA approved, speaks volumes about patients’ desire to be treated with HIFU. This is still very much a patient-driven treatment. Fifteen years ago when I was the only American urologist performing HIFU in the entire whole of the Americas, there was greater patient interest in seeking treatment than physician curiosity. With FDA approval, public awareness and education, it still remains a consumer-driven treatment. However, with FDA approval and physicians’ newfangled desire to learn about HIFU, I am convinced that it will become as much as a part of the armamentarium for prostate cancer as existing modalities. The reality is that more men are spending more time in researching alternatives treatments that offer a cure with less risk of compromise of quality of life factors.

 

 

     

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+1 #2 Charles Harman 2016-09-07 01:51
Now that you have FDA approval, do you expect the medical vacations to DR and Mexico to diminish and the treatments become more localized? This is particular interest to me as the FDA has been perceived to stand in the way of new modalities and treatment options.
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0 #1 Jan Dennis Mayer 2016-09-04 15:25
Where is the proposed TURP done and how much time must there be between the TURP and the Hifu. I have med to high BPH. is this an issue I am am to have the Hifu successfully done?
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