Transurethral Laser Technology: Treatments for BPH

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1 Transurethral Laser Technology: Treatments for BPH Richard Lee, MD Departments of Urology and Public Health The New York Presbyterian Hospital Weill Medical College of Cornell University

2 Background Traditional surgical approach based on relieving bladder outlet obstruction: Minimally invasive therapies Thermotherapies Novel hybrid therapies Surgical debulking procedures Vaporizers and enucleators Robotics vs. lasers vs. electrosurgical technologies

3 Basic Debulking Concepts All energy modalities employ concepts involving Resection and enucleation techniques Vaporization techniques Techniques vary on mechanism of action of energy modality Can affect efficacy and morbidity Large glands require transurethral surgical skill regardless of technology utilize

4 Traditional Monopolar PK Technology Traditional Bipolar Geavlete, Bogdan. Transurethral resection (TUR) in saline plasma vaporization of the prostate vs. standard TUR of the prostate: the better choice in benign prostatic hyperplasia? BJUI. 2010;

5 Lasers: Effects of Thermal-based Energy Coagulation vs. Vaporization Coagulation: Occurs when heating of tissue is below 100 C. Proteins denature, and necrosis ensues. Coagulation necrosis and gradual atrophy Clinical sloughing of necrotic tissue, i.e. a debulking of the prostate Vaporization: Occurs when heating of tissue is higher than 100 C Causes tissue & water to vaporize Instantaneous debulking of prostatic tissue

6 Current Laser Prostatectomy Wavelengths Holmium (2120 nm wavelength) Frequency and intermittent pulsing regime and power Thulium Laser (2013 nm wavelength) Frequency and continuous pulsing regime and power Greenlight (532 nm wavelength) High power ( Watts) Diode (980 nm wavelength) High power ( Watts)

7 Absorption Spectra of Laser Wavelengths

8 Laser Tissue Effects of Various Wavelengths

9 Theoretical Observations Ablation/Vaporization Greenlight > diode > Nd:YAG > Thulium > Holmium Vaporization/Enucleation vs. Enucleation/Morcellation Best published data is Holmium with Enucleation (thulium probably similar with improved ablative effects) Best vaporization is 532 nm > 980 nm Defect is only as good as committed surgeon who attains it

10 Holmium:YAG laser 2120nm wavelength favors H 2 O as chromophore Absorption by water results in high-temperature vapor bubble explosions with a thermo-mechanical vaporization effect on target tissue pulsatile thermo-mechanical mechanism of action with vaporization of water Up to 50Hz at 2 joules with 550nm endfire fiber Used for lithotripsy, HoLEP, HoLAP, and urethral strictures HoLEP requires morcellation

11 HoLEP

12 Clinical Performance Multiple studies examining HoLEP vs. TURP Gupta, et al. BJU Int 2006; 97: Kuntz,et al. J Urol 2004; 172: Montorsi, et al. J Urol 2004; 172: Tan, et al. J Urol 2003; 170: Shah, et al. BJU Int (1):

13 Meta-analysis of 6 RCTs of HoLEP vs. TURP Yin L, et al. J Endourol 2013 epub ahead of print

14 Yin L, et al. J Endourol 2013 epub ahead of print

15 Yin L, et al. J Endourol 2013 epub ahead of print

16 Yin L, et al. J Endourol 2013 epub ahead of print

17 HoLEP appears to possess superior blood loss, catheterization time, and LOS compared to TURP but at the cost of longer operative time Clinical efficacy superior with HoLEP Problems with meta-analysis Study heterogeneity, varying durations of followup Yin L, et al. J Endourol 2013 epub ahead of print

18 Holmium Laser Summary HoLAP Typically limited to small glands less than 40ml Limited peer review publications HoLEP Excellent safety and efficacy data compared to TURP/ open prostatectomy Good durability Limited to centers of excellence Excellent published data but by dedicated centers Long learning and technical curve Needs morcellators Tan AH, et al. BJU Int 92; 2003: Barski D, et al. World J Urol 2012 epub ahead of print

19 Thulium:YAG laser 2130nm wavelength similar to 2120nm wavelength of holmium Similar favoring of H 2 O as chromophore pulsatile thermomechanical mechanism of action with vaporization of water Also uses endfire fiber Difference is higher power and continuous wave More efficient ablator of tissue but requires morcellator

20 Prospective, single-institution trial of 1080 patients undergoing ThuVEP from Jan 2007 to May 2012 Median prostate size: 51ml (30g resected weight) Median operative time: 56min Prior therapy α-blockers: 69.3% 5α-reductase therapy: 22.7% Gross AJ, et al. Eur Urol 63:2013;

21 Gross AJ, et al. Eur Urol 63:2013;

22 Gross, et al. Eur Urol 63:2013;

23 Equivalent improvement in IPSS: 21.9 to 3.5, p=0.46 Equivalent improvement in Qmax: 8ml/s to 23.7mL/s, p=0.77 Equivalent improvement in PVR: 93ml to 5.2mL, p=0.41 Gross AJ, et al. Eur Urol 63:2013;

24 Major complications 1 patient with MI No deaths Complication rates decreased with learning curve: 41.7% in 1 st 216 cases vs. 19.4% in last 216 cases, p<0.001 Decrease in transfusion rates (3.2% vs. 0%, p<0.007), urinary retention (9.3% vs. 4.2%, p<0.034), and overall morbidity (24.5% vs. 13%, p<0.0017) Gross AJ, et al. Eur Urol 63:2013;

25 Prospective RCT of 100 consecutive patients with BPH randomized to TURP vs. ThuVEP Xia SJ, et al. Eur Urol 53:2008;

26 Xia SJ, et al. Eur Urol 53:2008;

27 No difference in IIEF score, p=0.67 No difference in complication rates Xia SJ, et al. Eur Urol 53:2008;

28 Conclusions ThuVEP equivalent to TURP in terms of clinical efficacy ThuVEP was superior to TURP for decreases in Hb and Na, catheterization time, and length of stay Gross AJ, et al. Eur Urol 63:2013;

29 RCT of 133 patients treated with ThuLEP (n=71 at 70W) vs. HoLEP (n=62 at 90W) Mean prostate volume: 44.7cm 3 Mean preoperative IPSS: 24.1 Mean preoperative Qmax: 7mL/s Mean preoperative PVR: 64.6mL Zhang F, et al. Urology 79:2012;

30 Zhang F, et al. Urology 79:2012;

31 Zhang F, et al. Urology 79:2012;

32 Clinical efficacy of ThuLEP and HoLEP equivalent ThuLEP superior for blood loss at the cost of a longer operative time Zhang F, et al. Urology 79:2012;

33 Diode laser 980nm wavelength with equal absorption by water and oxyhemoglobin compared to holmium and thulium wavelengths Deep optical penetration with Customized pulsing regime (adjustable to continuous) Uses 70º side-fire fiber in near-contact technique

34 Prospective evaluation of 47 consecutive patients with BPH from Sept 2007 to Apr 2008 Underwent VLAP with diode laser at W in continuous mode in near-contact fashion Mean operative time: minutes Mean energy delivered: kJ No differences in pre- vs. postoperative Hb or Na All patients except for n=2 discharged on POD1 Erol A, et al. J Urol 182:2009;

35 Erol A, et al. J Urol 182:2009;

36 Erol A, et al. J Urol 182:2009;

37 VLAP with diode laser shows short-term improvement in LUTS Procedure appears safe with a reasonable rate of adverse events High rate of irritative symptoms postoperative may be due to high optical penetration leading to tissue necrosis effects Erol A, et al. J Urol 182:2009;

38 Greenlight laser 532nm wavelength transmitted with no absorption by water irrigant selectively absorbed by hemoglobin chromophore Laser powers up to 180W Uses side-fire fiber in non-contact technique Excellent vaporization with 1-2mm of coagulation for hemostasis

39 Randomized series PVP vs. TURP Articles Horasanli K, et al. Urology 2008;71(2): Bouchier-Hayes DM, et al. J Endourol 2006;20(8): Randomized vs. open prostatectomy Tasci AI, et al. J Endourol 2008;22(2): Comparative series Alivizatos G, et al. Eur Urol 2007;53(2): Yang et al. Zhonghua Wai Ke Za Zhi 2007;45(14): Verger-Kuhnke AB, et al. Arch Esp Urol 2007;60(2): Bachmann A, et al. Eur Urol 2005;48(6):

40 PVP and Anticoagulant Use Sandhu JS, et al. J Endourol 2005;19(10) : men Warfarin, clopidogrel, aspirin No blood transfusions. Ruszat R, et al. Eur Urol. (2007) 51(4): men Coumarin derivatives, aspirin, clopidogrel. No blood transfusions. Malloy TR, et al. J Urol 2005, 173(4): men dicumarol, warfarin, dipyridamole, enoxaparin, heparin, ticlopidine, clopidogrel, tirofiban, and/or eptifibatide No blood transfusions. Yuan, et al. Postgrad Med J. 2008, 84(987): high-risk patients. Fateri et al. Rev Med Suisse. 2007, 3(136):2794-7

41 Large Glands: Reproducible Results Sandhu et al. Urology. 2004;64(6): Horasanli et al. Urology. 2008;71(2): Alivizatos et al. Eur Urol 2008; 54(2): Rajbabu et al. BJU Int. 2007;100(3): Ruszat et al. Urologe A. 2006;45(7): Tugcu et al. Urol Int. 2007;79(4): Pfitzenmaier et al. BJU Int. 2008;72(1): Chandrasekera, et al. Abstract, EUA, Istanbul, Turkey, 2005 Krishnamoorthy, et al. Abstract, EUA, Paris, France, 2006 Lam, et al. Abstract, ASLMS, Boston, Mass, USA, 2006 Yakupoglu, et al. Abstract #1522, AUA, Atlanta, Georgia, USA, 2006

42 Meta-analysis of 9 studies comparing PVP vs. TURP for treatment of BPH Teng J, et al. BJU Int 111:2012;

43 Teng J, et al. BJU Int 111:2012;

44 No difference seen Teng J, et al. BJU Int 111:2012;

45 Improved EBL (1.33, p<0.0003), catheterization time (2.95, p< ), and length of stay (2.91, p< ) for PVP but longer operative time (-17.94, p=0.004) favoring TURP Teng J, et al. BJU Int 111:2012;

46 Improved transfusion rate (5.88, p=0.002), capsular penetration (9.28, p=0.001), and dilutional hyponatremia (5.31, p=0.03) with PVP Urethral stricture rate equivalent Lower re-intervention rate with TURP (0.24, p=0.002) Teng J, et al. BJU Int 111:2012;

47 Prospective evaluation of 80 patients with BPH >60mL randomized to HPS PVP (n=37) vs. HoLEP (n=43) from Oct 2008 to Oct 2010 Mean prostate volume: 89 vs. 91cc, p=0.6 Erol A, et al. J Urol 182:2009;

48 Erol A, et al. J Urol 182:2009;

49 Erol A, et al. J Urol 182:2009;

50 Erol A, et al. J Urol 182:2009;

51 Subjective clinical outcomes equivalent between HoLEP and PVP Higher conversion ratio with HoLEP surprising given greater learning curve unless one considers that the author institution is considered center of excellence for HoLEP May also account for superior Qmax, PVR, and PSA results Erol A, et al. J Urol 182:2009;

52 Transurethral Laser Enucleation/Incision/Vaporization of Prostate TLEP Ureteral Orifice Verumontanum

53 Summary Evolution of transurethral technologies towards laser-based treatments Holmium, thulium, diode, Greenlight Each laser technology carries specific advantages and disadvantages based on the properties of the laser beam and the interacting tissue Goal is to replicate create a TUR-like defect Defect is only as good as committed surgeon who attains it

54 AUA Symptom Index Score Improvements for Surgical Therapies chapt_3_appendix.pdf

55 Questions?

Submitted: August 15, Accepted: September 10, Published: October 15, 2018.

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