EXTRACORPOREAL SHOCK-WAVE LITHOTRIPSY WITH LITHOSTAR LITHOTRIPTOR NELSON RODRIGUES NETTO, GUSTAV0 C. LEMOS, M.D. JOAQUIM E A. CLARO, M.D.
JR., M.D.
From the Division of Urology, Hospital Albert Einstein, Sao Paulo, Brazil
Israelita
ABSTRACT-Initial experience of extracorporeal shock-wave lithotripsy (ESWL) using the Lithostar lithotriptor is reported; 193 patients underwent 248 treatments for 210 stones. A total of 139 renal calculi (126 patients) and 71 ureteral stones (67 patients) were analyzed. Treatments were performed without anesthesia in 65 calculi (27.6%), with intravenous sedation in 91 (42.5 %), and under epidural anesthesia in 34 calculi (29.9 %). A three-month follow-up showed a success rate of 88.0 percent for renal calculi and 95.5 percent for ureteral calculi treated in situ. Renal stone fragmentation was achieved with a mean of 4,890 shocks at 17.4 kV and ureteral calculi were fragmented with a mean number of 4,798 shocks at a mean of 18.3 kV Auxiliary procedures after ESWL were required in 2 patients with renal stones and in 1 with ureteral calculi. A comparison between stone size and number of shock waves required to achieve stone fragmentation revealed a linear relationship. Hospitalization was not necessary in 84.4 percent of renal calculi and 89.6 percent of ureteral calculi. Retreatments were necessary in 22 (15.8 %) of the renal calculi (18 had 2 sessions, 3 had 3 sessions, and 1 had 4 sessions). Of the ureteral calculi, 8 (11.3 %) underwent retreatment (6 had 2 sessions, 1 had 3 sessions, and 1 had 4 sessions). The low morbidity with a large number of patients treated on an outpatient basis, minimizing the need for anesthesia, demonstrated a favorable initial successful experience with the Lithostar.
Extracorporeal shock-wave lithotripsy (ESWL) has become the major treatment modality for renal stones. Because of the success with this technique in the treatment of renal stones, attempts also have been made to disintegrate ureteral stones. The initial results were of limited success when the Dornier HM3” lithotriptor dominated early experience with ESWL. l However, a second-generation lithotriptor was introduced in 1986. Recent attention has been directed to determine the relationship of location and size of stones and the amount of energy (number of shocks and kilovoltage) used for disintegration. We report our experience with the *Dornier
430
Medical
Systems,
Inc.,
Marietta,
Georgia.
Siemens Lithostar? in the management calculi and ureteric calculi in situ. Material
of renal
and Methods
The first electromagnetic acoustic shockwave unit (EMAS) in Brazil was delivered in October 1987 to Hospital Israelita Albert Einstein in Sao Paulo. Between December 1987 and December 1989, 193 patients were given 248 treatments for 210 calculi. In this clinical trial, the mean age of the 105 men and 88 women was forty-five years (range 6 to 86 years). There were 139 renal calculi (66.2 % ); TSiemens Medical
UROLOGY
/
Systems,
NOVEMBER
Inc.,
1992
Iselin,
New Jersey.
/ VOLUME
40. NUMBER
5
TABLE I.
Data stratified by stone size and localization 1 I
I TOTAL
STONESIZE
~______________-__________--______--___--~
I ( 1 CR ,I 1 -2 cn I LOCALIZATION _________________________________~__-_________~_____________I_______--___, I 21 : 31 : N CALCULI PELVIC
12CR
I II I : I a______ 1
I 68 16 6,200 t 2,000-11,400: t 79.41 81.25 I ‘_____________:_______~
: ,I I I
3 I 5,200 I : 5,000-5,400 100 I
I 19 I I I 89.47
I I I I
4 I 1 ItlDDLE N CALCULI : b I : 6,000 HEAN NURBER SHOCKS! 3,000 I 5,000 1 RANNGE 1 l,OOO-4,000 I 3,000-8,000 t 100 SUCCESS Z i 83.33 I 75.00 _________________________________I______________~_____*_______~_______-____-~_-___--~
t 11 I I f 81.92
: I I :
I 41 I
I I I I
4,034 NEAN NURBER SHOCKS; 4,077 1 : 3,000-9,400 I 1,800-12,OOOT RANHIGE f 76.19 I 80.65 SUCCESS Z _________________________________:__________---_~__-----------, CALM:
UPPER
LOWER
I N CALCULI REAN NUHBER SHOCKS: I RANGE : SUCCESS I
N CALCULI NEIlN NMBER RANGE SUCCESS Z
e 1,987 500~4,bOO 97.50
1 20 SHOCKS! 3,255 I 500-9,000 T 75.00
B : 3,775 : I 3,000~6,200 97.50 I
19 I ‘I 4,400 I 2,000~8,000 I 73.69
:
I 2 f 11,500 I 3,000-20,000: I 50.00
I 73.17
,
URETERMPER
N MLCULI ftE4N RUHBER SHOCKS! RANGE SUCCESS % ____________________-____________) RIDDLE
LOWER
N CALCULI HEI\N NMBER RANGE SUCCESS %
17 I 2 I 30 ‘r 11 ! f 5,750 : I 4,000 : 3,964 1 : 2,000-6,000: 3,000~S,OOOi 5,500~6,000 I I 100 I 96.67 I 1 100 I 94.12 _____________~_____________I______________~_______~
:
: SHOCKS1 : i
N CALCULI , REAN NUYBER SHOCKS! RANGE : SUCCESS Z f
11 I 2 f lb 3 I I 10,500 I 2,800 I 4,818 2,400-3,000: 3,000~8,000 I lO,OOO-11,000: 100
17 3,558 500-9,000 68.24
68 stones (48.9 %) were in the renal pelvis and 71 (51.1%) were caliceal stones. There were 19 calculi in the upper calix, 11 in the middle calix, and 41 in the lower calix. Of the 71 (33.8%) ureteric stones, 30 (42.3 % ) were sited in the upper third, 16 (22.5%) in the mid, and 25 (35.2 % ) in the lower ureter. Patients were divided according to stone size into three groups: stones smaller than 1 cm, between 1 and 2 cm, and larger than 2 cm. Patients with a stone in the proximal ureter were placed in the standard supine position, while
UROLOGY
i
NOVEMBER
1992
i
I
VOLUME 40, NUMBER 5
12.73
7 : I 3,800 I 3,000-5,000 100 t
I
100
, I I
4,000 -
I
1
0
I 81.25
I I
I f
: ! I
1 88.00
I
I
25
f I
those with a stone overlying the pelvic brim were placed in the prone position, and those with the stone in the distal ureter were placed in the supine position but rotated head to foot on the table. ESWL was used, and no attempts were made to manipulate these calculi back into the kidney (push back procedure). No ureteral catheter was used. Secondary ureteral stone fragments after previous renal ESWL were not included in this study. Of a total of 139 renal calculi, 22 were larger than 2 cm. In these patients a Double-J catheter
431
TABLE II.
Results of ESWL treatment
Renal
Caliceal
Ureter al
No. of pts.
60
66
67
No. calculi cleared at 3 mos. Success ( %) No. of treatments 1 session 2 sessions 3 sessions 4 sessions Hospitalization (%) Outpatient (%) Anesthesia No (%) Sedation (%) Epidural (%) General (%) Shocks * Kilovolts *
i!(91.7)
;; (84.8)
;: (95.5)
61 (85.9) 7 (9.9) 2 (2.8) 1 (1.4) 4 (6.1) 62 (93.9)
63 (88.7) 6 (8.5) 1 (1.4) 1 (1.4) 7 (10.4) 60 (89.6)
24 (36.4) 30 (45.5) 12 (18.2)
24 (35.8) 33 (49.3) 9 (13.4) 1 (1.5) 4,790 18.3
56 (82.3) 11 (16.1) 1 (1.5) 15 (25.0) 45 (75.0) 17 (28.3) 28 (46.7) 13 (21.7) 2 (3.3) 4,860 17.2
4,900
17.6
*Average number,
was placed which was kept in place until the stones were completely cleared or up to the end of the third postoperative month. Before treatment, each patient underwent investigation which included a baseline plain film of the kidneys, ureters, and bladder and an intravenous urogram. At the end of the procedure a plain abdominal radiograph was obtained. All patients had plain abdominal films or a nephrotomogram performed on the first day after ESWL and monthly until the stones were completely cleared. The radiographs were reviewed by ourselves and by the radiologists at our institution. Stone clearance was defined as the absence of kidney stone fragments on the nephrotomogram or on a plain abdominal radiograph for ureteral calculi. Our data were stratified to analyze the relationship between stone size and site and the number of shock waves required for stone disintegration (Table I). The greatest diameter was the criterion utilized for stone measurement. Results The treatment was considered successful if radiologic study showed complete removal of all calculous material. Results were analyzed separately for pelvic, caliceal, and ureteral calculi. The success in stone removal, hospitalization, anesthesia, size of the stone, average number of shocks and kilovolts are shown in Table II. Follow-up at three months was available for all patients, and 175 (90.7%) of them were free of stones.
432
Retreatments were performed in 30 (15.5 % ) patients. Of a total of 126 patients with renal calculi, in 41 (32.5%) the treatment was well tolerated with only mild discomfort and the procedure was carried out without anesthesia, 58 (46.0 %) received intravenous sedation (diazepam plus fentanyl), 25 (19.8%) had epidural anesthesia, and 2 (1.6 %) had general anesthesia. Of 67 patients with ureteral stone, 9 (13.4 %) patients needed epidural anesthesia, 33 (49.3%) needed intravenous sedation, 1 (1.5 % ) needed general anesthesia, and in 24 (35.8 % ) the procedure was performed without anesthesia (Table II). Of a total of 126 patients with renal calculi, 107 (84.9%) were treated without hospitalization. Indeed, 3 patients required hospitalization after ESWL, 1 of whom required percutaneous nephrostomy due to obstruction and severe kidney dilation, and 2 for the treatment of persistent steinstrasse. The average hospital stay for this group was one day. Among 67 patients with ureteral calculi, 60 were treated without hospitalization (89.6%) and 7 patients (10.4%) were hospitalized for a mean period of one day. Retreatment was necessary in 12 (17.6%) of the 68 renal pelvic calculi, 11 had 2 sessions and 1 underwent 3 sessions. Of the 71 caliceal stones, 10 (14.1%) underwent retreatment. A total of 7 had 2 sessions, 2 had 3 sessions, and 1 had 4 sessions. Among the 71 ureteral calculi, 8 (11.2%) underwent retreatment while 6 had 2 sessions, 1 underwent 3 sessions, and 1 had 4 sessions,
UROLOGY
/
NOVEMBER
1992
/
VOLUME 40, NUMBER 5
TABLE
III.
Comparison
Series Drach et al., 19863 W!Z~?Zra!I”Z874 ’ (Lithostar) Clayman and McClennan, (Lithostar) Rassweiller et al., 1988e (Lithostar) Grace et al., 198g7 (Lithostar) Netto, Lemos, Claro (Lithostar)
of results of ESWL
No. of Pts.
Stone Disintegration (%)
Auxiliary Procedures After ESWL (%)
Secondary Treatment (%)
Stone-Free After 3 Mos. (%)
2,501
92
17
16
66.2
400
96
12
12
98
175
87
16
20.6
59
628
97
11.4
69
145
90
19
88
193
94
1.5
18.6
91
10.7
16.3
81
19885
1,541
TOTAL
Correlation between stone size and shock waves delivered to achieve stone fragmentation is demonstrated in Table I. The mean number of shock waves was 4,844 for all the stones. A positive correlation exists between renal stone size and the number of shocks required to fragment the stone (r = 0.30, p
JR., M.D.
From the Division of Urology, Hospital Albert Einstein, Sao Paulo, Brazil
Israelita
ABSTRACT-Initial experience of extracorporeal shock-wave lithotripsy (ESWL) using the Lithostar lithotriptor is reported; 193 patients underwent 248 treatments for 210 stones. A total of 139 renal calculi (126 patients) and 71 ureteral stones (67 patients) were analyzed. Treatments were performed without anesthesia in 65 calculi (27.6%), with intravenous sedation in 91 (42.5 %), and under epidural anesthesia in 34 calculi (29.9 %). A three-month follow-up showed a success rate of 88.0 percent for renal calculi and 95.5 percent for ureteral calculi treated in situ. Renal stone fragmentation was achieved with a mean of 4,890 shocks at 17.4 kV and ureteral calculi were fragmented with a mean number of 4,798 shocks at a mean of 18.3 kV Auxiliary procedures after ESWL were required in 2 patients with renal stones and in 1 with ureteral calculi. A comparison between stone size and number of shock waves required to achieve stone fragmentation revealed a linear relationship. Hospitalization was not necessary in 84.4 percent of renal calculi and 89.6 percent of ureteral calculi. Retreatments were necessary in 22 (15.8 %) of the renal calculi (18 had 2 sessions, 3 had 3 sessions, and 1 had 4 sessions). Of the ureteral calculi, 8 (11.3 %) underwent retreatment (6 had 2 sessions, 1 had 3 sessions, and 1 had 4 sessions). The low morbidity with a large number of patients treated on an outpatient basis, minimizing the need for anesthesia, demonstrated a favorable initial successful experience with the Lithostar.
Extracorporeal shock-wave lithotripsy (ESWL) has become the major treatment modality for renal stones. Because of the success with this technique in the treatment of renal stones, attempts also have been made to disintegrate ureteral stones. The initial results were of limited success when the Dornier HM3” lithotriptor dominated early experience with ESWL. l However, a second-generation lithotriptor was introduced in 1986. Recent attention has been directed to determine the relationship of location and size of stones and the amount of energy (number of shocks and kilovoltage) used for disintegration. We report our experience with the *Dornier
430
Medical
Systems,
Inc.,
Marietta,
Georgia.
Siemens Lithostar? in the management calculi and ureteric calculi in situ. Material
of renal
and Methods
The first electromagnetic acoustic shockwave unit (EMAS) in Brazil was delivered in October 1987 to Hospital Israelita Albert Einstein in Sao Paulo. Between December 1987 and December 1989, 193 patients were given 248 treatments for 210 calculi. In this clinical trial, the mean age of the 105 men and 88 women was forty-five years (range 6 to 86 years). There were 139 renal calculi (66.2 % ); TSiemens Medical
UROLOGY
/
Systems,
NOVEMBER
Inc.,
1992
Iselin,
New Jersey.
/ VOLUME
40. NUMBER
5
TABLE I.
Data stratified by stone size and localization 1 I
I TOTAL
STONESIZE
~______________-__________--______--___--~
I ( 1 CR ,I 1 -2 cn I LOCALIZATION _________________________________~__-_________~_____________I_______--___, I 21 : 31 : N CALCULI PELVIC
12CR
I II I : I a______ 1
I 68 16 6,200 t 2,000-11,400: t 79.41 81.25 I ‘_____________:_______~
: ,I I I
3 I 5,200 I : 5,000-5,400 100 I
I 19 I I I 89.47
I I I I
4 I 1 ItlDDLE N CALCULI : b I : 6,000 HEAN NURBER SHOCKS! 3,000 I 5,000 1 RANNGE 1 l,OOO-4,000 I 3,000-8,000 t 100 SUCCESS Z i 83.33 I 75.00 _________________________________I______________~_____*_______~_______-____-~_-___--~
t 11 I I f 81.92
: I I :
I 41 I
I I I I
4,034 NEAN NURBER SHOCKS; 4,077 1 : 3,000-9,400 I 1,800-12,OOOT RANHIGE f 76.19 I 80.65 SUCCESS Z _________________________________:__________---_~__-----------, CALM:
UPPER
LOWER
I N CALCULI REAN NUHBER SHOCKS: I RANGE : SUCCESS I
N CALCULI NEIlN NMBER RANGE SUCCESS Z
e 1,987 500~4,bOO 97.50
1 20 SHOCKS! 3,255 I 500-9,000 T 75.00
B : 3,775 : I 3,000~6,200 97.50 I
19 I ‘I 4,400 I 2,000~8,000 I 73.69
:
I 2 f 11,500 I 3,000-20,000: I 50.00
I 73.17
,
URETERMPER
N MLCULI ftE4N RUHBER SHOCKS! RANGE SUCCESS % ____________________-____________) RIDDLE
LOWER
N CALCULI HEI\N NMBER RANGE SUCCESS %
17 I 2 I 30 ‘r 11 ! f 5,750 : I 4,000 : 3,964 1 : 2,000-6,000: 3,000~S,OOOi 5,500~6,000 I I 100 I 96.67 I 1 100 I 94.12 _____________~_____________I______________~_______~
:
: SHOCKS1 : i
N CALCULI , REAN NUYBER SHOCKS! RANGE : SUCCESS Z f
11 I 2 f lb 3 I I 10,500 I 2,800 I 4,818 2,400-3,000: 3,000~8,000 I lO,OOO-11,000: 100
17 3,558 500-9,000 68.24
68 stones (48.9 %) were in the renal pelvis and 71 (51.1%) were caliceal stones. There were 19 calculi in the upper calix, 11 in the middle calix, and 41 in the lower calix. Of the 71 (33.8%) ureteric stones, 30 (42.3 % ) were sited in the upper third, 16 (22.5%) in the mid, and 25 (35.2 % ) in the lower ureter. Patients were divided according to stone size into three groups: stones smaller than 1 cm, between 1 and 2 cm, and larger than 2 cm. Patients with a stone in the proximal ureter were placed in the standard supine position, while
UROLOGY
i
NOVEMBER
1992
i
I
VOLUME 40, NUMBER 5
12.73
7 : I 3,800 I 3,000-5,000 100 t
I
100
, I I
4,000 -
I
1
0
I 81.25
I I
I f
: ! I
1 88.00
I
I
25
f I
those with a stone overlying the pelvic brim were placed in the prone position, and those with the stone in the distal ureter were placed in the supine position but rotated head to foot on the table. ESWL was used, and no attempts were made to manipulate these calculi back into the kidney (push back procedure). No ureteral catheter was used. Secondary ureteral stone fragments after previous renal ESWL were not included in this study. Of a total of 139 renal calculi, 22 were larger than 2 cm. In these patients a Double-J catheter
431
TABLE II.
Results of ESWL treatment
Renal
Caliceal
Ureter al
No. of pts.
60
66
67
No. calculi cleared at 3 mos. Success ( %) No. of treatments 1 session 2 sessions 3 sessions 4 sessions Hospitalization (%) Outpatient (%) Anesthesia No (%) Sedation (%) Epidural (%) General (%) Shocks * Kilovolts *
i!(91.7)
;; (84.8)
;: (95.5)
61 (85.9) 7 (9.9) 2 (2.8) 1 (1.4) 4 (6.1) 62 (93.9)
63 (88.7) 6 (8.5) 1 (1.4) 1 (1.4) 7 (10.4) 60 (89.6)
24 (36.4) 30 (45.5) 12 (18.2)
24 (35.8) 33 (49.3) 9 (13.4) 1 (1.5) 4,790 18.3
56 (82.3) 11 (16.1) 1 (1.5) 15 (25.0) 45 (75.0) 17 (28.3) 28 (46.7) 13 (21.7) 2 (3.3) 4,860 17.2
4,900
17.6
*Average number,
was placed which was kept in place until the stones were completely cleared or up to the end of the third postoperative month. Before treatment, each patient underwent investigation which included a baseline plain film of the kidneys, ureters, and bladder and an intravenous urogram. At the end of the procedure a plain abdominal radiograph was obtained. All patients had plain abdominal films or a nephrotomogram performed on the first day after ESWL and monthly until the stones were completely cleared. The radiographs were reviewed by ourselves and by the radiologists at our institution. Stone clearance was defined as the absence of kidney stone fragments on the nephrotomogram or on a plain abdominal radiograph for ureteral calculi. Our data were stratified to analyze the relationship between stone size and site and the number of shock waves required for stone disintegration (Table I). The greatest diameter was the criterion utilized for stone measurement. Results The treatment was considered successful if radiologic study showed complete removal of all calculous material. Results were analyzed separately for pelvic, caliceal, and ureteral calculi. The success in stone removal, hospitalization, anesthesia, size of the stone, average number of shocks and kilovolts are shown in Table II. Follow-up at three months was available for all patients, and 175 (90.7%) of them were free of stones.
432
Retreatments were performed in 30 (15.5 % ) patients. Of a total of 126 patients with renal calculi, in 41 (32.5%) the treatment was well tolerated with only mild discomfort and the procedure was carried out without anesthesia, 58 (46.0 %) received intravenous sedation (diazepam plus fentanyl), 25 (19.8%) had epidural anesthesia, and 2 (1.6 %) had general anesthesia. Of 67 patients with ureteral stone, 9 (13.4 %) patients needed epidural anesthesia, 33 (49.3%) needed intravenous sedation, 1 (1.5 % ) needed general anesthesia, and in 24 (35.8 % ) the procedure was performed without anesthesia (Table II). Of a total of 126 patients with renal calculi, 107 (84.9%) were treated without hospitalization. Indeed, 3 patients required hospitalization after ESWL, 1 of whom required percutaneous nephrostomy due to obstruction and severe kidney dilation, and 2 for the treatment of persistent steinstrasse. The average hospital stay for this group was one day. Among 67 patients with ureteral calculi, 60 were treated without hospitalization (89.6%) and 7 patients (10.4%) were hospitalized for a mean period of one day. Retreatment was necessary in 12 (17.6%) of the 68 renal pelvic calculi, 11 had 2 sessions and 1 underwent 3 sessions. Of the 71 caliceal stones, 10 (14.1%) underwent retreatment. A total of 7 had 2 sessions, 2 had 3 sessions, and 1 had 4 sessions. Among the 71 ureteral calculi, 8 (11.2%) underwent retreatment while 6 had 2 sessions, 1 underwent 3 sessions, and 1 had 4 sessions,
UROLOGY
/
NOVEMBER
1992
/
VOLUME 40, NUMBER 5
TABLE
III.
Comparison
Series Drach et al., 19863 W!Z~?Zra!I”Z874 ’ (Lithostar) Clayman and McClennan, (Lithostar) Rassweiller et al., 1988e (Lithostar) Grace et al., 198g7 (Lithostar) Netto, Lemos, Claro (Lithostar)
of results of ESWL
No. of Pts.
Stone Disintegration (%)
Auxiliary Procedures After ESWL (%)
Secondary Treatment (%)
Stone-Free After 3 Mos. (%)
2,501
92
17
16
66.2
400
96
12
12
98
175
87
16
20.6
59
628
97
11.4
69
145
90
19
88
193
94
1.5
18.6
91
10.7
16.3
81
19885
1,541
TOTAL
Correlation between stone size and shock waves delivered to achieve stone fragmentation is demonstrated in Table I. The mean number of shock waves was 4,844 for all the stones. A positive correlation exists between renal stone size and the number of shocks required to fragment the stone (r = 0.30, p
