Relative Role of ESWL, Retrograde Ureteroscopy and PCNL for Urolithiasis John D Denstedt, MD, FRCSC, FACS Professor of Urology Schulich School of Medicine & Dentistry Western University London, Canada Hippocrates Oath I shall not use the knife for patients but trust them to artisans who set themselves to curing these problems 1
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Modern Stone Age Percutaneous approach (Johansson, 1976) Intracorporeal Lithotripsy (Alken, 1978) Ureteroscopy (Perez-Castro, 1980) SWL (Chaussey, 1980) Holmium:YAGLaser (Denstedt 1993) 3
Treatment of Upper Urinary Tract Calculi Factors to consider: Stone size Location Composition Anatomic factors Failure of other therapies Renal function Age Sex Factors to consider: Body habitus, comorbidities Ureteral access issues SWL availability, operator experience Ureteroscopy, PCNL experience Chances of being stone free 7 Treatment Decisions by Stone Burden Stone burden is the single most important factor in determining outcome and treatment modality When stone burden increases, stone free rates decrease and need for ancillary procedures and re-treatment increases The presence of multiple stones also adversely affects the results of SWL 4
Non-Staghorn Calculi Treated with SWL: Stratified by Size % 100 90 80 70 60 50 40 30 20 10 0 <11 mm 11-20 mm 21-30 mm >30 mm Stone Free Retreatment Ancillary Procedures Residual Fragments Following SWL SWL increases stone surface area may enhance stone growth Higher stone recurrence rate in patients treated with SWL than PCNL Carr et al, J Urol 1998 Significant number of patients with fragments (43%) develop symptoms or require treatment within 2 years Streem et al, J Urol 1996 5
Renal Anatomy and Stone Disease UPJ obstruction Horseshoe kidney Ectopic / fusion abnormalities Calyceal diverticulum Lower pole calyx Any cause of hydronephrosis Any alteration in anatomy decreases success with SWL Treatment Decision by Stone Composition Resistance to SWL Most to Least Cystine Brushite CaOx Monohydrate Struvite CaOx Dihydrate Uric Acid 6
Shockwave Lithotripsy Advantages Non-invasive Low complication rate Out-patient procedure Limitations Lower stone-free rate SWL: Effects On Blood Pressure Conflicting Results! Measurable Effect On BP No Difference in BP Lingeman et al JAMA 263:1990 Yokoyamo et al J UROL 553: 1992 Claro et al J UROL 150: 1993 Jewett et al J UROL 160: 1998 Elves et al BJU 85: 2000 Janetschek et al (Patients < 60) J UROL 158: 1997 7
Retrospective review 261 SWL pts, compared to Statistics Canada data Univariate analysis: Unmodified HM3 associated with DM! Hypertension more prevalent in litho patients Multivariate analysis: NO correlation!!! How can we maximize the effectiveness of ESWL? Patient selection ESWL technique Adjuvant treatments New technology 8
Predicting SWL Success: HU SWL Renal Calculi (< 20 mm) Lithostar Multiline HU % Stone Free < 500 100 500-1000 86 > 1000 55 Joseph et al, J Urol 2002 Predicting Effectiveness of SWL by Stone Attenuation Value 99 patients divided into 2 groups HU > 1200 (57) or < 1200 (42) Statistical differences Mean number of shocks Mean shock intensity Retreatment rate Efficiency quotient Encourages alternative approach if HU > 1200 M Desai et al, J Endourol July 2010 9
Predicting SWL Success: SSD Skin-to-stone distance Doli S lithotriptor (EM) Calculated by measuring 3 distances by NCCT scan from the center of the stone to the skin 0, 45, 90 degrees for LP stones (size 0.5 1.5 cm) SSD BMI HU density SF (30 pts) 8.12 26.1 66.3 RS (34 pts) 11.53 28.5 92.5 An SSD > 10 cm predicted treatment failure Pareek et al, Urology 2005 Stone Attenuation Skin-to-Stone Distance Perks et al, Urology 72, 2008 10
Stone Attenuation Skin-to-Stone Distance Retrospective study of 111 patients who underwent SWL Stone attenuation of < 900 HU and SSD < 9 cm predict success of SWL independent of stone size, location and BMI Success rates < 900 HU / < 9 cm 91% < 900 HU / > 9 cm 79% > 900 HU / < 9 cm 58% > 900 HU / > 9 cm 41% Skin to stone Distance Stone Density Ellipsoid stone volume (Diameter) J Endo February 2015 22 11
96.1% 78.7% Stone Free Rate Average SFR 57.1% 21.4% 41.3% Tripe D Score 23 J Endo February 2015 9 RCT s including 1,572 cases 120 vs 90, 120 vs 60 and 90 vs 60 Slower is better for stones > 1 cm, p<0.001 No difference for stones < 1 cm 90 Hz is optimal frequency for > 1cm 120 Hz is adequate for < 1 cm 12
Optical Coupling Control in SWL: First Clinical Experience Blind swiping vs visual control swiping Camera in therapy head à identify air bubbles in coupling area à removed under visual control Total applied energy 38.0% for renal stones Air free coupling increases SWL efficiency! Renal Stones Required SW -25.4% -25.5% Energy level -23.1% -22.5% Ureteral Stones Tai l l y et al, J Endo, November 2014 519 pre-training vs 83 post-training SWL Overall success rate: 66.3 à 87.2 (P<0.0001). Mean # of SWL treatments: 1.8 1.8 à 1.4 1.3 (P = 0.01) Lithotripsy training is essential to achieve optimal results with SWL 26 13
In vitro stone model, phantom calyx and pelvis Acoustic radiation force, focused beam along propagation axis, 5-40 W acoustic power, US guided Stone moves from calyx to pelvis at 1cm/s 10W is required to move 8mm stone 27 Role of Medical Expulsive Therapy Zhu et al, BJU Int 106, 2009 14
Medical Expulsive Therapy RCT considered 7 trials with 484 patients Available studies characterised by Heterogeneity Lack of placebo arm All used Tamsulosin at either 0.2 or 0.4mg MET superior in terms of: Stone clearance (NNT=6) Time to stone expulsion Reduced analgesic requirement Well designed, placebo controlled RCT required 15
J Urol 193; 2015 BJU Int 113(3), 2014 16
ESWL Cases Number of ESWL procedures performed per year at St. Joseph s Health Care London, Ontario 3000 2500 2000 1500 1000 500 0 1990 1995 2000 Number of ESWL procedures 2005 2010 2015 Year 33 Indications for PCNL Large stone volume Staghorn calculi Cystine composition Associated distal obstruction UPJO, Tic, etc Renal anomalies Horseshoe, pelvic Morbidly obese or orthopedic condition Certainty of result Aviators, struvite Other modality failure 17
Results: Stone Free Rates Stratified According to Surface Area Surface Area (mm 2 ) PCNL% Stone free % 1-500 52.7 97.9 501-1000 26.7 94.6 1001-1500 9.4 92.9 >1500 11.2 88.6 Duvdevani et al, J Endourol 21:824-829, 2007 18
CROES PCNL Global study 5803 Patients at 96 centers 27.5% Staghorn caculi 90% Access by urologist 1.5% Above 11th rib 15.2% Above the 12 th 8% Multiple tracts 41.1% Balloon dilation Lithotrite Pneumatic 41.6%, US 24%, combined 18.3%, Laser 7.0%, EHL 1.0% 1304 940 2603 956 37 CROES PCNL Global study Nephrostomy tube 91.2%, DJ 42.7% Complications Fever >38.5 C 10.5% Significant bleeding 7.8% Blood transfusion 5.7% Renal pelvis perforation 3.4% Hydrothorax 1.8% Stone free rate 75.7% Additional treatment in 15% Low major complication rate High success rate 19
AUA Guidelines on Management of Staghorn Calculi Recommendations Percutaneous nephrolithotomy should be the first treatment utilized for most patients If combination therapy is undertaken percutaneous nephroscopy should be the last procedure for most patients Shock wave lithotripsy monotherapy should not be used for most patients Open surgery should not be used for most patients 20
PCNL for Staghorn Calculi Percutaneous Nephrolithotomy for Staghorn Calculi: A Single Center s Experience over 15 Years Frédéric Soucy, Raymond Ko, Mordechai Duvdevani, Linda Nott, John D. Denstedt, Hassan Razvi Series of 509 patients with partial or complete staghorn calculi Stone clearance achieved with single tract in 84% SFR 78% at discharge 91% at 3 months No difference seen in terms of Transfusion rates (0.8% in staghorn group) Pulmonary / hemorrhagic complications J Endourology October 2009 41 Management Options for Lower Pole Renal Calculi Lower pole stones smaller than 1 cm can be managed with observation, SWL or ureteroscopy Lower pole stones 1-2 cm best managed by PCNL Ureteroscopy is an option in selected patients Patients with lower pole stones > 2 cm best managed by PCNL Body habitus, renal anatomy, cost and patient preference should be considered when determining optimal treatment Raman and Pearle, Curr Opin Urol 2008 42 21
Advances in Percutaneous Nephrolithotripsy Urologist performed access Upper pole approach Improved endoscope design Improved intracorporeal lithotriptors Secondary nephroscopy techniques Decreased size & duration of nephrostomy (Bellman) 43 Prospective data on 5724 patients entered into CROES database 96 centers Overall 20.5% complications (n=1175 patients) 44 22
Overall 54% of complications were Clavien Grade 1 45 Fever > 38.5 C 10.5% Bleeding 7.8% Blood transfusion 5.7% Renal Pelvic Perforation 3.4% Hydrothorax 1.8% Mortality 0.0003% (n=2) 46 23
NIS data, 1999-2009, 80,097 pts PCNL use has increased in both and : 3.03/100000 à 3.63/100000 : 2.99/100000 à 4.07/100000 Complication rate : 12.2 à15.6% Sepsis rate : 1.2% à 2.4% Mortality rate stable Patients treated are older (51 à 55y) and have more comorbidities (22.3 à 33.2%) 47 Percutaneous Nephrolithotomy of Calyceal Diverticular Calculi: PCNL A for Single Staghorn Centre Experience Calculi Carlos E. Méndez-Probst, Andrew Fuller, Linda Nott, John D. Denstedt, Hassan Razvi 76 calyceal stones treated with PCNL Mean stone area was 583 mm 2 Surgical approach Direct puncture - 47 Trans diverticular - 20 Retrograde - 8 Unknown - 1 patient Average duration of surgery 75 min (23 to 169) Mean hospital stay of 4.7 days Stone free rates were 77% and 89% for direct puncture and trans diverticular approaches respectively 48 J Endourol, August 2011 24
Percutaneous Nephrolithotripsy in Patients with Urinary Diversions: A Case-Control PCNL for Comparison Staghorn of Perioperative Calculi Outcomes Alfonso Fernandez, Kirsten Foell, Linda Nott, John D. Denstedt, Hassan Razvi 33 PCNL procedures on 25 patients with urinary diversion Urinary diversion associated with Higher likelihood of Radiologist access (40% vs 0%, p<0.001) Increased need for second look nephroscopy (36% vs 16%, p=0.046) Struvite stone composition (80% vs 12.5%, p=0.006) Higher risk of post-operative sepsis (8% vs 0%, p=0.038) No significant difference seen with regard to Stone free rates Complications Transfusion rates Length of hospital stay J Endourol, October 2011 49 Treatment of Ureteral Stones Therapeutic Options Spontaneous passage Medical therapy SWL Ureteroscopy Open surgery Laparoscopic Special Considerations Anticoagulated Pregnant Obese Pediatrics To stent or not? Post ureteroscopy imaging necessary? 50 25
Spontaneous Stone Rates According to Passage Size 100% Spontaneous Stone Passage (%) 80% 60% 40% 20% 0% 1 mm 2-4 mm 5-7 mm 7-9 mm >9 mm Stone size (mm) Coll Am J Roentgenol 2002 Results of Expulsive Therapy Author Agent(s) Agent(s) Agent(s) Recommend Borghi J Urol 1994 N=86 Dellabella J Urol 2003 N=60 Dellabella J Urol 2005 N=210 Dellabella Urology 2005 N=60 Prednisolone + nifedipine 87% 11.2 d 65% / 16.4 d Tamsulosin Prednisolone + placebo Steroid + Ca++ blocker Floroglucinetrimetossibenzene (anti-spasmodic) 100% 2.75 d 70%: 4.6 d Phloroglucinol 64% 5 d Tamsulosin 90% 5 d Tamsulosin 97% 3 d Corticosteroid + Tamsulosin 97% 3 d Nifedipine 77% 5 d Tamsulosin Tamsulosin Tamsulosin + Steroid time 52 26
Patients were randomized into 3 groups: 378 patients received 0.4 mg Tamsulosin 379 patients received 30 mg Nifedipine 379 patients received placebo Follow-up in 4 weeks The need for intervention was used as a surrogate to stone passage No radiological follow-up performed Compliance with medication intake was not assessed Lancet, July 2015 53 54 Lancet, July 2015 27
Counseling Patients Observation Shockwave lithotripsy Ureteroscopy Success Risk 55 SWL Pros Pros and Cons of Shockwave Lithotripsy Least invasive Avoid general anesthetic Outpatient procedure Low complication rate SWL Cons Stone-free rates > 80% but not as high as ureteroscopy Higher re-treatment / ancillary procedure rates - higher cost Not available in every centre 56 28
Pros and Cons of Ureteroscopy Ureteroscopy Pros Close to 100% stone-free rates Negligible re-treatment rates Less costly? Available to most urologists Ureteroscopy Cons More invasive Higher complication rate? ie strictures Need for a general anaesthetic? 57 Ureteral stones 29
Upper Ureteral Stone Management Reason Not to Use SWL Previous shock wave failure Large stones Hard stones Obstruction and stone Certainly of final result Obesity or other patient factors Trend in 2016 is towards more ureteroscopy and less SWL 59 ENDOUROLOGY Its about having the right instrument in your hand x ureteral 30
Digital Endoscopes The Way of the Future DUR-D Digital ureteroscope 9.3-8.7 Fr tapered shaft 3.6 Fr working channel 250 0 primary deflection 80 0 field of view Larger image No camera LithoVue Disposable Flexible Ureteroscope Single-use Eliminates concerns of fragile, short-lifespan ureteroscopes Dynamic Can reliably get to the entirety of the renal collecting system Digital 31
Objective A novel single use flexible ureteroscope, promises the optical characteristics and maneuverability of a non-disposable 4 th generation flexible ureteroscope. The single use flexible ureteroscope (LithoVue, Boston Scientific) was directly compared to contemporary flexible ureteroscopes, with regards to optics, ureteroscope deflection and irrigation flow. COMPARISON LithoVue (Single Use, Boston Scientific, USA) Flex-Xc (Karl Storz, Germany) Cobra (Richard Wolf, Germany) 32
OPTICS Comparison The LithoVue showed the largest field of view, with excellent resolution, image distortion and depth of field. Image Resolution OPTICS Comparison BSc LithoVue Storz Flex-Xc Wolf Cobra Platform Digital Digital Fiberoptic Resolution at 10mm (lines/mm) 7.13 8.00 4.00 33
OPTICS Comparison Image Distortion BSc LithoVue Storz Flex-Xc Wolf Cobra Platform Digital Digital Fiberoptic Image Distortion 3.6% 22.6% 16.7% OPTICS Comparison Depth of Field and Field of View BSc LithoVue Storz Flex-Xc Wolf Cobra Platform Digital Digital Fiberoptic Depth of Field 4.5mm 6.0mm 4.0mm Field of View 15.75mm 10.45mm 14.25mm 68 34
DEFLECTION Comparison The LithoVue maintained full deflection ability with all instruments, though the Flex-Xc and Cobra showed loss of deflection ranging from 2 to 27 depending on the instrument placed. BSc LithoVue Storz Flex- Xc Empty 276 263 253 Laser (200um) 274 254 251 Basket (1.9F) 271 263 248 NPL probe (2.0F) 274 256 250 Wolf Cobra NPL probe (2.4F) 273 236 234 69 IRRIGATION FLOW COMPARISION 45 40 35 30 25 20 15 10 5 0 P=0.003 P<0.001 P=0.12 Empty 200um laser Basket Lithoview Flex-Xc Wolf Note: Flex-Xc and LithoVue have 3.6F working channels. Wolf has dual 3.3F working channels. 70 35
Ho:YAG in 23 URS and in 4 flexible nephroscopies during PCNL 92% success rate, 1 ureteral perforation due to laser Successful in fragmenting stones of any stone composition Laser set-up is quick and simple, targeting beam is easily seen, allowing precise placement of the fiber on the stone 71 71 patients Mean stone size 7.4 mm Intraoperative complications 2.8% (2/71) Postoperative complications 8.7% (6/71) 3 UTI, 2 AUR, 1 pulmonary edema Overall Stone free rate 95% Stone free rate 100% for stones < 1cm J Urol January, 2015 72 36
149 patients 1-2 cm renal stones Flexible ureteroscopy SFR 91.4% and 6.3% complication Renal stones with mean size of 2.5 cm Average stone free rate 93.7% Range 77% to 96.7% Average 1.6 procedures/patient Overall complications 10.1% 5.3% major 4.8% minor 37
7 studies 131 patients, 136 renal units Treated with furs Mean age 53.3 (19-67) years Mean BMI 42.2 (30.13-65.2) kg/m 2 Mean stone size 1.37 (0.4-7.2) cm Most stones fragmented using Holmium:YAG laser BJU Int 2012 75 Stone free rate 87.5% Complication rate 11.4% All Clavien I or II except for one patient with ureteric perforation (grade III) BJU Int 2012 76 38
systematic review 6 studies (282 pts) of furs in children with renal stones The mean age was 7.3 yrs Stone size range from 1-30mm Stone free average 85.5% (range 58-93%) after initial URS Preoperative stenting was required in 26% - 96% 77 14 studies 108 patients 9 complications, no difference to complication rate as compared to multinational meta-analysis of ureteroscopy in nonpregnant women J Urol, (181) 2009 78 39
Uncorrected Bleeding Diathesis Option for URS Watterson et al reported flexible URS in 25 patients with upper tract stones 100% had uncorrected bleeding diatheses Stone free rate was 96% 0% bleeding complications in the 23 treated with Holmium laser Watterson et al, J Urology 2002 79 Ureteral Stent Discomfort is Common and Debilitating Stent-related pain (80%) Urinary symptoms (78%) Reduced work capacity (58%) Sexual dysfunction (32%) Flank pain (25%) Irritative bladder symptoms (19%) Hematuria (18%) Bacteriuria (15%) Fever (12%) R Damiano et al, Urology Int 2002 HB Joshi et al, J Urology 2003 40
58 Patients enrolled prospectively Surgery: 6.9Fr rigid or 7.5Fr flexible ureteroscope holmium laser or electrohydraulic lithotripsy patient randomized if procedure uncomplicated All patients followed at one, six and twelve weeks post-operatively Stented patients have stents removed at first visit with flexible cystoscopy 343 Randomized Patients Pain/LUTS Authors Denstedt et al, 2001 Borboroglu et al, 2001 Byrne et al, 2002 # of Pts Stent / No Stent Flank Pain LUTS 29 / 29 in stented in stented 53 / 54 in stented in stented 38 / 22 (renal units) in stented in stented (day 6 only) Chen et al, 2002 30 / 30 No difference in stented Cheung et al, 2003 29 / 29 in stented (overall pain) in stented p 0.05 for all groups 41
578 Randomized Patients Stone-Free Rate Authors # of Pts Stent / No Stent Stent No Stent Denstedt et al, 2001 29 / 29 100% 100% Netto et al, 2001 133 / 162 98.5% 97.5% Borboroglu et al, 2001 53 / 54 99.1% (Overall) Chen et al, 2002 30 / 30 100% 100% Cheung et al, 2003 29 / 29 97% (IVP) 97% (IVP) Admissions Secondary Stent Insertion Authors # of Pts Stent / No Stent Readmission (%) Stent / No Stent Secondary Stent Insertion (%) Denstedt et al, 2001 29 / 29 3.4 / 0 0 Borboroglu et al, 2001 53 / 54 0 / 7.4 3.7 Byrne et al, 2002 38 / 22 (renal units) 2.6 / 9.1 4.5 Chen et al, 2002 30 / 30 0 / 0 0 42
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