Extracorporeal Shock-Wave Lithotripsy and Endoscopy for the Treatment of Pain in Chronic Pancreatitis : A Sham-Controlled, Randomized Trial.

BACKGROUND: No randomized controlled trials have substantiated endoscopic decompression of the pancreatic duct in patients with painful chronic pancreatitis. OBJECTIVE: To investigate the pain-relieving effect of pancreatic duct decompression in patients with chronic pancreatitis and intraductal stones. DESIGN: 24-week, parallel-group, randomized controlled trial (ClinicalTrials.gov: NCT03966781). SETTING: Asian Institute of Gastroenterology in India from February 2021 to July 2022. PARTICIPANTS: 106 patients with chronic pancreatitis. INTERVENTION: Combined extracorporeal shock-wave lithotripsy (ESWL) and endoscopic retrograde pancreatography (ERP) compared with sham procedures. MEASUREMENTS: The primary end point was pain relief on a 0- to 10-point visual analog scale (VAS) at 12 weeks. Secondary outcomes were assessed after 12 and 24 weeks and included 30% pain relief, opioid use, pain-free days, questionaries, and complications to interventions. RESULTS: 52 patients in the ESWL/ERP group and 54 in the sham group were included. At 12 weeks, the ESWL/ERP group showed better pain relief compared with the sham group (mean difference in change, -0.7 [95% CI, -1.3 to 0] on the VAS; P = 0.039). The difference between groups was not sustained at the 24-week follow-up, and no differences were seen for 30% pain relief at 12- or 24-week follow-up. The number of pain-free days was increased (median difference, 16.2 days [CI, 3.9 to 28.5 days]), and the number of days using opioids was reduced (median difference, -5.4 days [CI, -9.9 to -0.9 days]) in the ESWL/ERP group compared with the sham group at 12-week follow-up. Safety outcomes were similar between groups. LIMITATION: Single-center study and limited duration of follow-up. CONCLUSION: In patients with chronic pancreatitis and intraductal stones, ESWL with ERP provided modest short-term pain relief. PRIMARY FUNDING SOURCE: Asian Institute of Gastroenterology and Aalborg University Hospital.

Sex-specific analysis of intravascular lithotripsy for peripheral artery disease from the Disrupt PAD III observational study.

OBJECTIVE: Endovascular therapy of lower extremity peripheral artery disease (PAD) is associated with higher complication rates and worse outcomes in women vs men. Although intravascular lithotripsy (IVL) has shown similarly favorable outcomes in men and women in calcified coronary arteries, there is no published safety and effectiveness data of peripheral IVL differentiated by sex. This study aims to evaluate sex-specific acute procedural safety and effectiveness following IVL treatment of calcified PAD. METHODS: We performed a secondary analysis of the multicenter Disrupt PAD III Observational Study, which assessed short-term procedural outcomes of patients undergoing treatment of symptomatic calcified lower extremity PAD with the Shockwave peripheral IVL system. Adjudicated acute safety and efficacy outcomes were compared by sex using univariate analysis performed with the χ2 test or Fisher exact test, as appropriate. RESULTS: A total of 1262 patients (29.9% women) were included, with >85% having moderate to severe lesion calcification. Women were older (74 vs 71 years; P < .001), had lower ankle-brachial index (0.7 vs 0.8; P = .003), smaller reference vessel size (5.3 vs 5.6 mm; P = .009), and more severe stenosis at baseline vs men (82.3% vs 79.8%; P = .012). Rates of diabetes, renal insufficiency, chronic limb-threatening ischemia, lesion length, and atherectomy use were similar in both groups. Residual stenosis after IVL alone was significantly reduced in both groups. Final residual stenosis was 21.9% in women and 24.7% in men (P = .001). Serious angiographic complications were infrequent and similar in both groups (1.4% vs 0.6%; P = .21), with no abrupt vessel closure, distal embolization, or thrombotic events during any procedure. CONCLUSIONS: The use of IVL to treat calcified PAD in this observational registry demonstrated favorable acute safety and effectiveness in both women and men.

Multi-center experience with intravascular lithotripsy for treatment of severe calcification during transcarotid artery revascularization for high-risk patients.

OBJECTIVE: Transcarotid artery revascularization (TCAR) offers a safe alternative to carotid endarterectomy (CEA), but severe calcification is currently considered a contraindication in carotid artery stenting. This study aims to describe the safety and effectiveness of TCAR with intravascular lithotripsy (IVL) in patients with traditionally prohibitive calcific disease. METHODS: All consecutive patients who underwent TCAR+IVL from 2018-2022 at nine institutions were identified. IVL was combined with pre-dilatation angioplasty to treat calcified vessels before stent deployment. The primary outcome was a new ipsilateral stroke within 30 days. Secondary outcomes included any new ipsilateral neurologic event (stroke/transient ischemic attack [TIA]) at 30 days, technical success, and <30% residual stenosis. RESULTS: Fifty-eight patients (62% male; mean age, 78 ± 6.6 years) underwent TCAR+IVL, with 22 (38%) for symptomatic disease. Fifty-seven patients (98%) met high-risk anatomical or physiologic criteria for CEA. Forty-seven patients had severely calcific lesions. Fourteen patients (30%) had isolated eccentric plaque, 20 patients (43%) had isolated circumferential plaque, and 13 (27%) had eccentric and circumferential calcification. Mean procedure and flow reversal times were 87 ± 27 minutes and 25 ± 14 minutes. The median number of lithotripsy pulses per case was 90 (range, 30-330), and mean contrast usage was 29 mL. No patients had electroencephalogram changes or new deficits observed intraoperatively. Technical success was achieved in 100% of cases, with 98% having <30% residual stenosis on completion angiography. One patient had an in-hospital post-procedural stroke (1.72%). Four patients total had any new ipsilateral neurologic event (stroke/TIA) within 30 days for an overall rate of 6.8%. One TIA and one stroke occurred during the index hospitalization, and two TIAs occurred after discharge. Preoperative mean stenosis in patients with any postoperative neurologic event was 93% (vs 86% in non-stroke/TIA patients; P = .32), and chronic renal insufficiency was higher in patients who had a new neurologic event (75% vs 17%; P = .005). No differences were observed in calcium, procedural, or patient characteristics between the two groups. The mean follow-up was 132 days (range, 19-520 days). Three stents developed recurrent stenosis (5%) on follow-up duplex; the remainder were patent without issue. There were no reported interventions for recurrent stenosis during the study period. CONCLUSIONS: IVL sufficiently remodels calcified carotid arteries to facilitate TCAR effectively in patients with traditionally prohibitive calcific disease. One patient (1.7%) suffered a stroke within 30 days, although four patients (6.8%) sustained any new neurological event (stroke/TIA). These results raise concerns about the risks of TCAR+IVL and whether it is an appropriate strategy for patients who could potentially undergo CEA.

Review of intravascular lithotripsy for treating coronary, peripheral artery, and valve calcifications.

Management of intracoronary calcium (ICC) continues to be a challenge for interventional cardiologists. There have been significant advances in calcium treatment devices. However, there still exists a knowledge gap regarding which devices to choose for the treatment of ICC. The purpose of this manuscript is to review the principles of intravascular lithotripsy (IVL) and clinical data. The technique of IVL will then be compared to alternative calcium treatment devices. Clinical data will be reviewed concerning the treatment of coronary, peripheral artery and valvular calcifications. Controversies to be discussed include how to incorporate IVL into your practice, what is the best approach for treating calcium subtypes, how to approach under-expanded stents, what is the ideal technique for performing IVL, how safe is IVL, whether imaging adds value when performing IVL, and how IVL fits into a treatment program for peripheral arteries and calcified valves.

Current applications, procedural and 1-year outcomes of Rotatripsy for the treatment of calcified coronary lesions.

BACKGROUND: Intravascular lithotripsy (IVL) combined with rotational atherectomy (RA), known as Rotatripsy, is used to treat severe coronary artery calcification (CAC), though data on efficacy, midterm safety and use sequence is limited. We aimed to identify indicators for Rotatripsy use and to assess its safety and success rates, both acutely and at 1-year follow-up. METHODS: Patients undergoing Rotatripsy for severe CAC across six centers from May 2019 to December 2023 were included. Demographic, clinical, procedural and follow-up data were collected. Efficacy endpoints included device success (delivery of the RA-burr and IVL-balloon across the target lesion and administration of therapy without related complications), technical success (TIMI 3 flow and residual stenosis <30% by quantitative coronary analysis) and procedural success [composite of technical success with absence of in-hospital major adverse cardiovascular events (MACE: cardiac death, myocardial infarction or target vessel revascularization). Safety endpoints comprised Rotatripsy-related complications and MACE at 1-year follow-up. RESULTS: A total of 114 patients (75 ± 9 years, 78% male) underwent Rotatripsy for 120 lesions. In the majority of procedures RA was followed by IVL, mostly electively (n = 68, 57%) but also for balloon underexpansion (n = 37, 31%) and stent crossing failure (n = 1, 1%). Diverse and complex target lesions were addressed with an average SYNTAX score of 24.6 ± 13.0. Device, technical and procedural success were 97%, 94% and 93%, respectively. Therapy-related complications included two (2%) coronary perforations, one (1%) coronary dissection and one (1%) burr entrapment. At 1-year follow-up(present in 77(67%) patients), MACE occurred in 7(9%) cases. CONCLUSIONS: Over a 1-year follow-up period, Rotatripsy was safe and effective, predominantly using RA electively before IVL.

Efficacy of intravascular lithotripsy (IVL) in coronary stenosis with severe calcification: A multicenter systematic review and meta-analysis.

BACKGROUND: With heavily calcified coronary and peripheral artery lesions, lesion preparation is crucial before stent placement to avoid underexpansion, associated with stent thrombosis or restenosis and patency failure in the long-term. Intravascular lithotripsy (IVL) technology disrupts superficial and deep calcium by using localized pulsative sonic pressure waves, making it to a promising tool for patients with severe calcification in coronary bed. AIMS: The aim of the study is to systematically review and summarize available data regarding the safety and efficacy of IVL for lesion preparation in severely calcified coronary arteries before stenting. METHODS: This study was conducted according to the PRISMA guidelines. We systematically searched PubMed, SCOPUS, and Cochrane databases from their inception to February 23, 2023, for studies assessing the characteristics and outcomes of patients undergoing IVL before stent implantation. The diameter of the vessel lumen before and after IVL, as well as stent implantation, were analyzed. The occurrence of major adverse cardiovascular events (MACE) was assessed using a random-effects model. RESULTS: This meta-analysis comprised 38 studies including 2977 patients with heavily calcified coronary lesions. The mean age was 72.2 ± 9.1 years, with an overall IVL clinical success of 93% (95% confidence interval [CI]: 91%-95%, I2 = 0%) and procedural success rate of 97% (95% CI: 95%-98%, I2 = 73.7%), while the in-hospital and 30-days incidence of MACE, myocardial infarction (MI), and death were 8% (95% CI: 6%-11%, I2 = 84.5%), 5% (95% CI: 2%-8%, I2 = 85.6%), and 2% (95% CI: 1%-3%, I2 = 69.3%), respectively. There was a significant increase in the vessel diameter (standardized mean difference [SMD]: 2.47, 95% CI: 1.77-3.17, I2 = 96%) and a decrease in diameter stenosis (SMD: -3.44, 95% CI: -4.36 to -2.52, I2 = 97.5%) immediately after IVL application, while it was observed further reduction in diameter stenosis (SMD: -6.57, 95% CI: -7.43 to -5.72, I2 = 95.8%) and increase in the vessel diameter (SMD: 4.37, 95% CI: 3.63-5.12, I2 = 96.7%) and the calculated lumen area (SMD: 3.23, 95% CI: 2.10-4.37, I2 = 98%), after stent implantation. The mean acute luminal gain following IVL and stent implantation was estimated to be 1.27 ± 0.6 and 1.94 ± 1.1 mm, respectively. Periprocedural complications were rare, with just a few cases of perforations, dissection, or no-reflow phenomena recorded. CONCLUSIONS: IVL seems to be a safe and effective strategy for lesion preparation in severely calcified lesions before stent implantation in coronary arteries. Future prospective studies are now warranted to compare IVL to other lesion preparation strategies.

Predictors of persistent pain after extracorporeal shockwave lithotripsy for painful chronic calcific pancreatitis.

BACKGROUND: Extracorporeal shockwave lithotripsy (ESWL) and/or endoscopic retrograde cholangiopancreatography (ERCP) are recommended as first-line therapy for painful uncomplicated chronic pancreatitis with obstructed main pancreatic duct (MPD) in the pancreas head/body. However, predictors of pain relief after ESWL are unknown. We evaluated independent predictors of persistent pain in patients who underwent ESWL for chronic pancreatitis. METHODS: 640 consecutive adult patients with chronic pancreatitis, who underwent successful ESWL with ERCP and pancreatic duct (PD) stent placement, were followed for 12 months. The pain was assessed at baseline and at 12 months using the Izbicki Pain Score, with a score decrease of >50% considered pain relief. Independent predictors of pain relief were derived from logistic regression analysis. RESULTS: Of 640 patients (mean age 36.71 [SD 12.19] years; 60.5% men), 436 (68.1%) had pain relief and 204 (31.9%) had persistent pain. On univariate analysis, older age, male sex, alcohol and tobacco intake, longer duration of symptoms, dilated MPD and MPD stricture were associated with persistent pain at 12 months (P<0.05). Consumption of alcohol (odds ratio [OR] 1.93, 95%CI 1.26-2.97), tobacco (OR 4.09, 95%CI 2.43-6.90), duration of symptoms (OR 1.02, 95%CI 1.01-1.04), MPD size (OR 1.22, 95%CI 1.11-1.33), and MPD stricture (OR 8.50, 95%CI 5.01-14.42) were independent predictors of persistent pain. CONCLUSIONS: Alcohol, tobacco, duration of symptoms, MPD size and stricture were independent predictors of persistent pain after successful ESWL. A multidisciplinary team approach that includes behavioral therapy and surgical options should be considered for such patients.

Predictive markers for infections after extracorporeal shockwave lithotripsy in patients with kidney stone based on a large prospective cohort.

OBJECTIVE: Infections in patients with kidney stones after extracorporeal shockwave lithotripsy (SWL) is a common clinical issue. However, the associated factors are unclear. Therefore, we aim to develop and validate a predictive model for infections after SWL in patients with kidney stone. METHODS: Between June 2020 and May 2022, consecutive kidney stone patients were enrolled. Of them, 553 patients comprised the development cohort. One hundred sixty-five patients comprised the validation cohort. The data were prospectively collected. The stepwise selection was applied using the likelihood ratio test with Akaike's information criterion as the stopping rule; A predictive model was constructed through multivariate logistic regression. The performance was evaluated regarding discrimination, calibration, and clinical usefulness. RESULTS: Predictors of infections after SWL in treating kidney stones included older age (OR = 1.026, p = 0.041), female (OR = 2.066, p = 0.039), higher BMI (OR = 1.072, p = 0.039), lower stone density (OR = 0.995, p < 0.001), and higher grade of hydronephrosis (OR = 5.148, p < 0.001). For the validation cohort, the model showed good discrimination with an area under the receiver operating characteristic curve of 0.839 (95% CI 0.736, 0.941) and good calibration. Decision curve analysis demonstrated that the model was also clinically useful. CONCLUSION: This study indicated that age, gender, BMI, stone density, and hydronephrosis grade were significant predictors of infections after SWL in treating kidney stones. It provided evidence in optimizing prevention and perioperative treatment strategies to reduce the risk of infection after SWL.

Relocation of lower pole renal stones helps improve the stone-free rate during flexible ureteroscopy with a low complication rate.

OBJECTIVE: To compare the efficacy and safety of relocating the lower pole stones to a favorable pole during flexible ureteroscopy with in situ lithotripsy for the treatment of 10-20 mm lower pole stone (LPS). METHODS: This study was a prospective analysis of patient outcomes who underwent an FURS procedure for the treatment of 10-20 mm lower pole renal stones from January 2020 to November 2022. The patients were randomized into a relocation group or in situ group. The LPSs were relocated into a calyx, during lithotripsy in the relocation group was performed, whereas the in situ group underwent FURS without relocation. All the procedures were performed by the same surgeon. The patients' demographic data, stone characteristics, perioperative parameters and outcomes, stone-free rate (SFR), complications, and overall costs were assessed retrospectively. RESULTS: A total of 90 patients were enrolled and analyzed in this study (45 per group) with no significant differences between the two groups in terms of age, gender, BMI, diabetes, hypertension, stone size, number, laterality, composition, and density. The mean operation time, total energy consumption, postoperative stay, and complications were similar between the groups. Both groups had similar SFR at 1 day postoperative follow-up (p = 0.091), while the relocation group achieved significantly higher SFR 3 months later (97.8% vs 84.4%, p = 0.026). The relocation group also had a significantly higher WisQol score than the in situ group (126.98 vs 110.18, p < 0.001). CONCLUSION: A satisfactory SFR with a relatively low complication rate was achieved by the relocation technique during the FURS procedure.

Radiation exposure of patients during endourological procedures.

PURPOSE: Considering the existing gaps in the literature regarding patient radiation dose (RD) and its associated risks, a systematic review of the literature on RD was conducted, focusing on percutaneous nephrolithotomy (PCNL), extracorporeal shock wave lithotripsy (SWL), and ureteroscopy (URS). METHODS: Two authors conducted a literature search on PubMed, Web of Science, and Google Scholar to identify studies on RD during endourological procedures. Two thousand two hundred sixty-six articles were screened. Sixty-five publications met the inclusion criteria using the PRISMA standards. RESULTS: RD was generally highest for PCNL, reaching levels up to 33 mSv, 28,700 mGycm2, and 430.8 mGy. This was followed by SWL, with RD reaching up to 7.32 mSv, 13,082 mGycm2, and 142 mGy. URS demonstrated lower RD, reaching up to 6.07 mSv, 8920 mGycm2, and 46.99 mGy. Surgeon experience and case load were inversely associated with RD. Strategies such as optimizing fluoroscopy settings, implementing ultrasound (US), and following the ALARA (As Low As Reasonably Achievable) principle minimized RD. CONCLUSIONS: This is the first systematic review analyzing RD, which was generally highest during PCNL, followed by SWL and URS. There is no specific RD limit for these procedures. Implementation of strategies such as optimizing fluoroscopy settings, utilizing US, and adhering to the ALARA principle proved effective in reducing RD. However, further research is needed to explore the factors influencing RD, assess their impact on patient outcomes, and establish procedure-specific reference levels for RD.

Ureteral wall thickness as a predictor for non-invasive treatment success for steinstrasse. Can we save time?

PURPOSE: We aimed to define factors affecting the non-invasive overall treatment success (medical expulsive therapy (MET) ± shock wave lithotripsy (SWL)) for uncomplicated ureteral steinstrasse (SS) clearance. METHODS: We retrospectively evaluated consecutive patients who underwent SWL for renal stones between 2017 and 2021. Patients with uncomplicated SS were included. All patient's demographic and radiological data, e.g., age, gender, pre-SWL stenting, SS site, type, leading stone size in widest diameter (< 10 mm and ≥ 10 mm), ureteral wall thickness (UWT) in mm against the leading stone were collected. If SS was diagnosed, medical treatment was given for 4 weeks. In case of MET failure, either SWL for the leading stones + MET or direct URS was done. Non-invasive treatment success (SFR) was considered if complete clearance of SS occurred with no complications or the need for invasive intervention. RESULTS: A total of 145 patients were included with mean age of 45.9 ± 12.4 years. SFR in case of MET only occurred in 27.9%. Complications happened in 26 patients (17.9%). Non-invasive treatment SFR was achieved in 78 patients (53.8%) totally where SS type I, leading stone size ≤ 10 mm type and decreased UWT around the leading stone increased treatment success. CONCLUSION: Ureteral wall thickness is an important factor predicting SS management success. Besides the decreased UWT, non-invasive management should be offered for type I SS with leading stone ≤ 10 mm.

Ureteral stricture rate after endoscopic treatments for urolithiasis and related risk factors: systematic review and meta-analysis.

PURPOSE: We aimed to accurately determine ureteral stricture (US) rates following urolithiasis treatments and their related risk factors. METHODS: We conducted a systematic review and meta-analysis following the PRISMA guidelines using databases from inception to November 2023. Studies were deemed eligible for analysis if they included ≥ 18 years old patients with urinary lithiasis (Patients) who were subjected to endoscopic treatment (Intervention) with ureteroscopy (URS), percutaneous nephrolithotomy (PCNL), or shock wave lithotripsy (SWL) (Comparator) to assess the incidence of US (Outcome) in prospective and retrospective studies (Study design). RESULTS: A total of 43 studies were included. The pooled US rate was 1.3% post-SWL and 2.1% post-PCNL. The pooled rate of US post-URS was 1.9% but raised to 2.7% considering the last five years' studies and 4.9% if the stone was impacted. Moreover, the pooled US rate differed if follow-ups were under or over six months. Patients with proximal ureteral stone, preoperative hydronephrosis, intraoperative ureteral perforation, and impacted stones showed higher US risk post-endoscopic intervention with odds ratio of 1.6 (P = 0.05), 2.6 (P = 0.009), 7.1 (P < 0.001), and 7.47 (P = 0.003), respectively. CONCLUSIONS: The overall US rate ranges from 0.3 to 4.9%, with an increasing trend in the last few years. It is influenced by type of treatment, stone location and impaction, preoperative hydronephrosis and intraoperative perforation. Future standardized reporting and prospective and more extended follow-up studies might contribute to a better understanding of US risks related to calculi treatment.

A case report of ventricular fibrillation following Shockwave intravascular lithotripsy during percutaneous coronary intervention.

BACKGROUND: Shockwave intravascular lithotripsy (S-IVL) is widely used during percutaneous coronary intervention (PCI) of calcified coronary arteries. Ventricular capture beats during S-IVL are common but arrhythmias are rare. CASE PRESENTATION: A 75-year-old woman was scheduled for PCI to a short, heavily calcified chronic total occlusion of the right coronary artery. After wiring of the occlusion, S-IVL was used to predilated the calcified stenosis. During S-IVL, the patient developed ventricular fibrillation twice. CONCLUSION: To our knowledge, this is only the second reported case of VF during S-IVL. Although very rare, it is important to be aware of this potential and serious complication.

Bladder Stone Formation due to Intravesical Migration of the Intrauterine Device: A Report of 2 Cases.

INTRODUCTION: Approximately 5% of bladder stones occur in women and are usually associated with foreign bodies or urinary stasis. Spontaneous migration of the intrauterine device (IUD) into the bladder is a rare complication. In this report, we present 2 cases of migrated IUD who had undergone surgery at our clinic due to bladder stones. CASE PRESENTATIONS: We detected migrated IUDs into the bladder in 2 female patients, aged 37 and 56 years, who presented with lower urinary tract symptoms and urinary tract infection. In the first case, endoscopic cystolithotripsy was performed, and the IUD was removed without complications. In the second case, the IUD could not be removed endoscopically since it had fractionally invaded the bladder wall, and the IUD was removed without complications by performing an open cystolithotomy. CONCLUSION: A comprehensive gynecological history should be taken from every female patient presenting with recurrent urinary tract infections and lower urinary tract symptoms. If these patients have a history of IUD placement, the possibility of the intravesical migration of this device should be kept in mind.

Intravascular lithotripsy in peripheral lesions with severe calcification and its use in TAVI procedure - a meta-analysis.

Background: Heavily calcified peripheral artery lesions increase the risk of vascular complications, constituting a severe challenge for the operator during catheter-based cardiovascular interventions. Intravascular Lithotripsy (IVL) technology disrupts subendothelial calcification by using localized pulsative sonic pressure waves and represents a promising technique for plaque modification in patients with severe calcification in peripheral arteries. Purpose: Our aim was to systematically review and summarize available data regarding the safety and efficacy of IVL in preparing severely calcified peripheral arteries and its use in Transcatheter Aortic Valve Implantation (TAVI). Patients and methods: This study was conducted according to the PRISMA guidelines. We systematically searched PubMed, SCOPUS, and Cochrane databases from their inception to February 23, 2023, for studies assessing the characteristics and outcomes of patients undergoing IVL in the peripheral vasculature. The diameter of the vessel lumen before and after IVL was estimated. The occurrence of peri-procedural complications was assessed using a random-effects model. Results: 20 studies with a total of 1,223 patients with heavily calcified peripheral lesions were analysed. The mean age of the cohort was 70.6 ± 17.4 years. Successful IVL delivery achieved in 100% (95% CI: 100%-100%, I2 = 0%), with an increase in the luminal diameter (SMD: 4.66, 95% CI: 3.41-5.92, I2 = 90.8%) and reduction in diameter stenosis (SMD: -4.15, 95% CI: -4.75 to -3.55, I2 = 92.8%), and a concomitant low rate of complications. The procedure was free from dissection in 97% (95% CI: 91%-100%, I2 = 81.4%) while dissections of any type (A, B, C, or D) were observed in 6% (95% CI: 2%-10%, I2 = 85.3%) of the patients. Several rare cases of abrupt closure, no-reflow phenomenon, perforation, thrombus formation, and distal embolization were recorded. Finally, the subgroup analysis of patients who underwent a TAVI with IVL assistance presented successful implantation in 100% (95% CI: 100%-100%, I2 = 0%) of the cases, with only 4% (95% CI: 0%-12%, I2 = 68.96%) presenting dissections of any sort. Conclusions: IVL seems to be an effective and safe technique for modifying severely calcified lesions in peripheral arteries and it is a promising modality in TAVI settings. Future prospective studies are needed to validate our results.

[Phytoprophylaxis of complications after extracorporeal lithotrips].

AIM: To evaluate the efficiency of the drug phytolysin (capsules) in the prevention of complications after extracorporeal lithotripsy. MATERIALS AND METHODS: A total of 15 patients diagnosed with urolithiasis and chronic pyelonephritis in the latent phase were treated. The predominant localization of radiopaque stones no larger than 20 mm in size was the collecting system. The piezoelectric lithotripsy (1-2 sessions) was performed, followed by the administration of the herbal drug Phytolysin in the dosage form of a capsule. The follow-up was carried out after 14- and 30-days using laboratory, ultrasound and x-ray methods. RESULTS: In the postoperative period, there were no cases of the pyelonephritis, which may result from a short-term disturbance of the upper urinary tract urodynamics due to the passage of stone fragments. The antibacterial, antispasmodic, diuretic and anti-inflammatory effects of Phytolysin ensured positive changes in laboratory and bacteriological tests, contributed to the prevention of postoperative complications after extracorporeal lithotripsy (renal colic, pyelonephritis), and contributed to maintaining renal blood flow within normal limits and significantly reduced the time to stone-free status. CONCLUSIONS: Our results justify the feasibility of using phytolysin in capsules in patients with urolithiasis after extracorporeal lithotripsy. The dosage form in capsules eliminates the undesirable effects associated with the specific smell and taste, that patients noted when using phytolysin in the form of a paste.

In vivo evaluation of intravascular lithotripsy in a healthy porcine coronary model.

OBJECTIVES: In this study, we aimed to investigate the vascular response to an intravascular lithotripsy (IVL) shockwave balloon in a healthy porcine coronary artery model. BACKGROUND: IVL is a novel clinical technique for modifying heavily calcified atherosclerotic plaques. METHODS: A total of 24 porcine coronary arteries were treated with IVL or plain old balloon angioplasty (POBA). Histology, histomorphometry, quantitative coronary angiography analysis (QCA), and optical coherence tomography (OCT) were performed postprocedure and at 1-month follow-up (1M-FU). RESULTS: There was no significant difference in the late lumen loss and diameter stenosis (determined by QCA) and the minimal lumen area (evaluated by OCT) of the IVL and POBA groups at 1M-FU. Pathological analysis revealed that the lumen and neointima areas were similar between the two groups. However, the medial and adventitial layers were more prominent in the IVL than in the POBA group. The injury score and inflammation of the media and adventitia increased dramatically in the IVL group postprocedure and at 1M-FU. At 1M-FU, media fibrin deposition and adventitial fibrosis were also significantly increased in the IVL group. However, there was no significant difference in neointima fibrin deposition, endothelialization, and thrombosis between both groups. Layered separation of the media and adventitia was observed in the IVL group. CONCLUSION: The findings indicate that the IVL balloon did not cause serious intimal hyperplasia and endothelial damage compared with the effects of POBA in the healthy coronary artery. However, shock waves may cause unique damage to the vascular media and adventitia in the coronary artery, which was not observed in the peripheral artery.

Intravascular coronary lithotripsy for the treatment of iatrogenic calcium embolization: The "block and crack" technique.

Intracoronary calcium embolization during percutaneous procedure is a very rare and unpredictable event, that  can lead to serious complications and even expert operators could face some technical issues to solve it. This case report presents a technique called "block and crack" used to manage iatrogenic intracoronary calcium embolization of left anterior descending coronary artery. The technique involves implanting a drug eluting stent (DES) to block the embolus against the vessel wall, followed by the use of lithotripsy balloon inflated inside the DES to crack the calcium and achieve a better stent expansion. This technique allowed to avoid further distal calcium embolization as well as to minimize residual stenosis degree after stent implantation.

Intravascular lithotripsy compared to rotational atherectomy for the treatment of calcified distal left main coronary artery disease: A single center experience.

BACKGROUND: The safety and efficacy of intravascular lithotripsy (IVL) for the treatment of calcified distal left main (LM) disease remains unclear, especially compared to rotational atherectomy (RA). METHODS: We retrospectively analyzed the baseline clinical, angiographic, intravascular ultrasound (IVUS) characteristics and procedural outcomes of 107 patients who underwent distal LM percutaneous coronary intervention (PCI) with IVL (with or without adjunct atherectomy) versus RA alone for plaque modification before stenting at a single center between 2020 and 2022. RESULTS: A total of 50 patients underwent calcium modification with IVL with or without adjunct atherectomy and 57 with RA only. The mean age was 73 years and with a high prevalence of diabetes (58.9%), chronic kidney disease (42.1%), prior revascularization (coronary artery bypass graft surgery [36.4%] or prior PCI [32.7%]). Acute coronary syndrome was the primary indication for PCI in over 50% of the patients in both groups. Medina 1-1-1 LM bifurcation disease was identified in 64% and 60% of the IVL and RA groups (p = 0.64) respectively. Final minimum stent area in distal LM (>8.2 mm2 ), ostial LAD (>6.3 mm2 ) and ostial LCX (>5.0 mm2 ) were achieved in 96%, 85% and 89% of cases treated with IVL respectively and 93%, 93% and 100% of cases treated with RA respectively (LM p = 1.00; LAD p = 0.62; LCX; p = 1.00 for difference between the two groups). Procedural success (technical success without in-hospital major adverse events) was achieved in 98% of the IVL group and 86% of the RA-only group (p = 0.04). There were eight procedural complications (flow-limiting dissection, perforation, or slow/no-reflow) in the RA group compared to four in the IVL group (NS), and one patient in the RA required salvaged mechanical support compared to none in the IVL group. CONCLUSION: Plaque modification with coronary IVL appears to be efficacious and safe for the treatment of severely calcified distal LM lesions compared to RA only. Larger randomized studies are needed to confirm these findings.

Digital single-operator pancreatoscopy for the treatment of symptomatic pancreatic duct stones: a prospective multicenter cohort trial.

BACKGROUND: Digital single-operator pancreatoscopy (DSOP)-guided lithotripsy is a novel treatment modality for pancreatic endotherapy, with demonstrated technical success in retrospective series of between 88 % and 100 %. The aim of this prospective multicenter trial was to systematically evaluate DSOP in patients with chronic pancreatitis and symptomatic pancreatic duct stones. METHODS: Patients with symptomatic chronic pancreatitis and three or fewer stones ≥ 5mm in the main pancreatic duct (MPD) of the pancreatic head or body were included. The primary end point was complete stone clearance (CSC) in three or fewer treatment sessions with DSOP. Current guidelines recommend extracorporeal shock wave lithotripsy (ESWL) for MPD stones > 5 mm. A performance goal was developed to show that the CSC rate of MPD stones using DSOP was above what has been previously reported for ESWL. Secondary end points were pain relief measured with the Izbicki pain score (IPS), number of interventions, and serious adverse events (SAEs). RESULTS: 40 chronic pancreatitis patients were included. CSC was achieved in 90 % of patients (36/40) on intention-to-treat analysis, after a mean (SD) of 1.36 (0.64) interventions (53 procedures in total). The mean (SD) baseline IPS decreased from 55.3 (46.2) to 10.9 (18.3). Overall pain relief was achieved in 82.4 % (28/34) after 6 months of follow-up, with complete pain relief in 61.8 % (21/34) and partial pain relief in 20.6 % (7/34). SAEs occurred in 12.5 % of patients (5/40), with all treated conservatively. CONCLUSION: DSOP-guided endotherapy is effective and safe for the treatment of symptomatic MPD stones in highly selected patients with chronic pancreatitis. It significantly reduces pain and could be considered as an alternative to standard ERCP techniques for MPD stone treatment in these patients.