Vertebral Fracture Associated With Extracorporeal Shock Wave Lithotripsy: A Case Report.

Extracorporeal shock wave lithotripsy (ESWL) is considered a safe, reliable, and non-invasive modality for kidney stone management. However, there are well-established complications related to ESWL documented in the literature in the form of renal and extrarenal complications. Skeletal complications related to ESWL are rarely recorded; as far as we know, there is only one documented case report of an ESWL-related burst vertebral fracture seen in an osteoporotic patient, diagnosed as granulomatous spondylitis. Here, we present a novel case of a transverse process fracture of the third lumbar vertebra related to ESWL in a young patient otherwise free from any medical illness.

Risk factors of early infectious complications after ureterorenoscopy for stone disease: a prospective study.

PURPOSE: To prospectively evaluate the rate and associated risk factors of early infectious complications after ureterorenoscopy for urolithiasis. METHODS: After ethical committee approval, 400 therapeutic retrograde ureterorenoscopy procedures between August 3, 2020 and November 24, 2021 were included for analysis in a single-center study. Postoperative infection was defined as an afebrile urinary tract infection, fever (≥ 38 °C) with pyuria (≥ 300 WBC/µL) or proven urinary pathogen, and urosepsis. The primary outcome was the rate of infectious complications after ureterorenoscopy. Secondary outcomes were the perioperative factors that increased the risk of infectious complications within 30 days of surgery using univariate and multivariate logistic regression analysis. RESULTS: Twenty-nine of four hundred (7.3%) patients developed an infectious complication within 30 days after ureterorenoscopy. Ten (2.5%) patients developed an afebrile urinary tract infection, eight (2.0%) developed fever with pyuria, five (1.3%) febrile urinary tract infection, and six (1.5%) urosepsis. On univariate analysis, preoperative stent-type JFil® pigtail suture stent was significantly associated with the dependent variable (p < 0.001). On multivariate logistic regression analysis, older age (OR 1.035; 95% CI 1.006-1.070; p = 0.02) was found to be significantly associated with developing a postoperative infectious complication. CONCLUSIONS: A 7.3% rate of postoperative infectious complications and 1.5% urosepsis rate were observed after therapeutic ureterorenoscopy, without the need of intensive care admission. The only significant risk factors were preoperative stent type (JFil® pigtail suture stent) on univariate analysis, and older age on multivariate logistic regression analysis. Further multicentric prospective observational data are needed in this field.

Utility of the modified 5-item frailty index as a predictor of postoperative febrile urinary tract infection in patients who underwent ureteroscopy with laser lithotripsy.

PURPOSE: This study aimed to assess the effect of the modified 5-item frailty index on perioperative complications and surgical outcomes in patients who underwent ureteroscopy with laser lithotripsy for upper urinary tract stones. METHODS: Patients who underwent ureteroscopy with laser lithotripsy for upper urinary tract stones between 2019 and 2022 were reviewed retrospectively. Assessment was performed using the modified 5-item frailty index based on medical history (hypertension, diabetes, heart failure, chronic obstructive pulmonary disease) and functional status. Patients were categorized into the high (≥ 2) and low (≤ 1) modified 5-item frailty index groups based on the frailty score. We compared the perioperative complications and surgical outcomes between the two groups. RESULTS: Seventy-one (15.8%) and 393 (84.1%) of the 467 patients were classified into the high and low modified 5-item frailty index groups, respectively. The high modified 5-item frailty index group exhibited a significant association with increased febrile urinary tract infections compared to the low modified 5-item frailty index group [≥ 37.8 °C: 15 (20.3%) vs 13 (3.3%), p < 0.001; ≥ 38 °C: 9 (12.2%) vs 7 (1.8%), p < 0.001]. Surgical outcomes, including operative time and stone-free rate, did not differ significantly between the two groups. CONCLUSION: The modified 5-item frailty index is valuable for predicting postoperative complications, particularly febrile urinary tract infections, after ureteroscopy with laser lithotripsy for upper urinary tract stones. This index allows for practical preoperative risk assessment in patients who underwent ureteroscopy with laser lithotripsy.

Safety and Efficacy of Ureteroscopic Laser Lithotripsy in the Management of Ureteric Calculi in Pregnancy-Experience of a Tertiary Care Center.

Introduction: Ureteric colic in pregnancy is one of the common non-obstetric reasons for emergency department visits. Ureteric calculi present a significant threat to maternal and fetal health and definitive management often becomes necessary. Our aim is to assess the safety and efficacy of ureteroscopic laser lithotripsy in the management of ureteric stones in pregnancy. Material and methods: This is a prospective observational study of 3 years carried at a tertiary referral center. It includes all pregnant patients who underwent ureteroscopic laser lithotripsy for ureteric stones. Results: A total of 29 pregnant patients underwent ureteroscopic laser lithotripsy at our center in 3 years. The mean age of patients was 33.5 ± 6.2 years, and the mean gestation age at the time of ureteroscopy was 23.34 ± 5.9 weeks. The average stone size was 8.3 ± 3.6 mm and was predominantly found in upper ureter (62%). The mean operative time was 31 ± 8.9 min, and the average laser energy spent was 4.3 ± 1.1 kJ/case. There was no major Intraoperative complication, and the average hospital stay was 2.5 ± 1.5 days. Complete stone clearance was achieved in 93.1% of cases. Conclusion: Ureteroscopic laser lithotripsy is safe and effective treatment of ureteric stones in terms of obstetric outcome and stone clearance in pregnancy.

Intravascular Lithotripsy in an Adult With Fontan Pathway Obstruction.

Fontan pathway obstruction is a potentially serious complication characterized by an anatomical or functional narrowing anywhere in the cavo-pulmonary pathways. Here, we report the first case in the literature where an innovative Fontan conduit rehabilitation procedure with intravascular lithotripsy was used achieving a dramatic increase in the pathway size.

Extension of interval between adjacent pulse delivery cycles to deal with myocardial ischemia by intravascular lithotripsy: case report.

BACKGROUND: Intravascular lithotripsy (IVL) represents a novel approach in the management of coronary calcification. This technique employs acoustic pressure waves, generated by a shockwave balloon, to effectively fracture both superficial and deep calcification in situ. The efficacy and safety of IVL have been convincingly demonstrated through the Disrupt CAD I-IV studies. While IVL is associated with the occurrence of atrial and ventricular arrhythmias, there is no evidence to indicate it causes myocardial ischemia. CASE DESCRIPTION: A 71-year-old man was admitted presenting with chest pain. His previous coronary angiography revealed stenosis and calcification in the left anterior descending branch. An attempt to predilate the lesion using two Lacrosse non-slip element balloons was unsuccessful. Ventricular premature beats and transient ST-segment depression were captured during the utilization of IVL. The operator gradually extended the pulse emission interval across two consecutive cycles to mitigate myocardial ischemia. Notably, when the interval reached 30s, the patient had no chest pain or ST-segment changes. Subsequent images of intravascular ultrasound confirmed calcification ruptures. Therapeutic intervention included the placement of a stent and the application of a drug-coated balloon in the left anterior descending branch. A telephonic follow-up six months later indicated the patient had no discomfort. CONCLUSIONS: This case underscores the effectiveness of gradually extending the pulse emission interval as a strategic complement to the clinical application of IVL. In certain clinical scenarios, it may become imperative to suspend the pulse delivery to improve myocardial blood supply.

Percutaneous balloon mitral valvuloplasty with shockwave lithotripsy for the treatment of calcific mitral valve stenosis.

BACKGROUND: Calcific mitral stenosis (calcific MS) presents a challenge for surgical treatment and is a contraindication for most contemporary transcatheter mitral valve replacement devices (TMVR), rendering patients with very limited therapeutic options. AIMS: This study aims to assess the clinical and hemodynamic follow-up after mitral valve lithotripsy (MVL). METHODS: All consecutive patients who underwent MVL to treat symptomatic calcific MS at St Michael's Hospital, Toronto, Canada, were included. Patients were deemed unsuitable for mitral surgery or TMVR after heart team assessment. Patients with rheumatic MS or ≥moderate mitral regurgitation (MR) were excluded. The primary endpoint was a reduction in the invasive mitral gradient by ≥50% without significant (≥moderate) MR. RESULTS: Fifteen patients underwent MVL between 2021 and 2023 with a mean age of 74 ± 9 years; 53% were female, with a mean STS score of 10% ± 0.1%. Following MVL, there was a reduction in the invasively measured mean trans-mitral gradient compared to baseline (14 mmHg vs. 6 mmHg; p < 0.05). The primary endpoint was achieved in 8 patients (53%) with no major procedural complications. At follow-up (median 90 days, IQR 58-115 days), 14 (93%) patients reported improved symptoms from New York Heart Association (NYHA) Class III-IV to NYHA Class I-II (p < 0.01) with stable echo-derived mean gradient (7.7 mmHg ± 2 mmHg vs. 8.4 mmHg ± 2.9 mmHg (p = 0.7). CONCLUSIONS: In selected patients with symptomatic inoperable calcific MS, MVL was safe and associated with significant short-term clinical and hemodynamic improvement. MVL may represent a new compassionate therapy for this challenging cohort. Further studies are needed to determine the long-term outcomes and help define the role of IVL technology in treating calcific valvular conditions.

Peroral Pancreatoscopy-Guided Lithotripsy Compared with Extracorporeal Shock Wave Lithotripsy in the Management of Pancreatic Duct Stones in Chronic Pancreatitis: A Multicenter Retrospective Cohort Study.

BACKGROUND: Extracorporeal shock wave lithotripsy (ESWL) is a common treatment for pancreatic stones in chronic pancreatitis. In contrast, peroral pancreatoscopy-guided lithotripsy (POPS-L) remains underexplored, with limited comparative studies to ESWL. This study compared the treatment outcomes of disposable POPS-L tools and ESWL for pancreatic stones. METHODS: A retrospective analysis was conducted on 66 patients who had undergone pancreatic stone treatment at three institutions between 2006 and 2022. The treatment outcomes of POPS-L and ESWL were compared. RESULTS: This study included 19 and 47 patients who had undergone POPS-L and ESWL, respectively. In a comparison between POPS-L and ESWL, the stone clearance rates were 78.9% vs. 70.2% (p = 0.55), while the procedure-related complication rates were 21% vs. 6.3% (p = 0.09). The median total session counts were 1 vs. 5 (p < 0.01). The cumulative stone recurrence rates were comparable in both groups. Multivariate analysis revealed no significant factors influencing the stone clearance rates, and the choice between POPS-L and ESWL did not affect the stone clearance rates. CONCLUSIONS: POPS-L and ESWL exhibited comparable treatment outcomes in terms of stone clearance, complications, and recurrence rates. Furthermore, POPS-L is advantageous due to the need for fewer sessions to achieve pancreatic stone clearance.

The Management of Large Bladder Calculi by Utilizing Dual-Action Percutaneous Lithotripsy via Suprapubic Tube Sheath: A Novel Technique.

Bladder calculi commonly develop in patients with poor bladder emptying or those with retained foreign bodies within the bladder, leading to irritative voiding symptoms, hematuria, and an increased likelihood of refractory urinary tract infections. While many techniques exist for the treatment of bladder calculi, including endoscopic and open-surgical approaches, our novel technique may help manage exceptionally large or difficult-to-treat bladder calculi effectively. We present three patients with symptomatic bladder calculi ranging from 1.3 cm to 6.8 cm in size who were successfully treated by using our novel technique. Percutaneous access to the bladder was obtained by using a suprapubic catheter trocar and sheath to enable the utilization of a dual-action lithotriptor. Sheath insertion and lithotripsy were performed under direct visualization with a rigid cystoscope via the native urethra. This technique is easily learned and can be safely employed in patients in whom other methods may pose risks of higher morbidity.

Extracorporeal shock wave lithotripsy: retrospective study on possible predictors of treatment success and revisiting the role of non-contrast-enhanced computer tomography in kidney and ureteral stone disease.

Extracorporeal shock wave lithotripsy (ESWL) is a safe and efficient treatment option for urinary stone disease. The overall stone-free rate (SFR) varies significantly. This study aimed to assess the influence of stone size, location, stone density, and skin-to-stone distance (SSD), on the outcome of ESWL. We assessed whether pre-treatment non-contrast-enhanced CT scan (NCCT) confers significant advantages compared to kidney-ureter-bladder film (KUB) only. We reviewed the medical records of 307 cases (165 men, 142 women) with renal and ureteral stones treated consecutively at our institution with ESWL between 2020 and 2023. 44 of these underwent a NCCT. The outcome of ESWL was defined in two ways: visible stone fragmentation on KUB, and the need for further treatment. Overall success of fragmentation was 85% (261 patients). 61% of patients (n = 184) didn't need any further treatment. Stone size and location correlated significantly with treatment outcomes regarding the need for further treatment (p = 0.004) and stone fragmentation (p = 0.016), respectively. Unlike mean SSD (p = 0.462), the mean attenuation value (MAV) significantly correlated with the need for retreatment (p = 0.016). MAV seems to be a better predictor of treatment success (AUC of the ROC curve: 0.729), compared to stone size (AUC: 0.613). The difference between groups (with and without NCCT) in both treatment outcomes did not reach statistical significance. During decision-making, information regarding SSD and MAV can be useful in more dubious scenarios. However, it appears that their inclusion doesn't provide substantial advantages when compared to relying solely on KUB.

Coronary calcifications, the Achilles heel in coronary interventions.

Percutaneous coronary intervention in severely calcified coronaries has been associated with higher rates of procedural complications, including myocardial infarction and death in addition to increased frequency of coronary revascularization on an intermediate and long-term basis. The SYNTAX score, which is designed to assess the complexity of coronary artery disease and aids in choosing a revascularization method, allocates two points per lesion when there is heavy calcification present on fluoroscopy. With the advent of novel multimodality imaging technologies, the detection and evaluation of coronary calcifications improved significantly over the last decade. Several tools are now available for modifying calcified lesions including different types of dedicated balloons and atherectomy devices, which may create some degree of confusion regarding the suitable application of each instrument. The aim of this review is to cover this vital topic from different aspects. First, we tried to provide an overview on the pathophysiology and types of coronary calcification and its risk factors. Then, we outlined the available imaging modalities for the evaluation of calcified coronary lesions, highlighting the points of strength and weakness of each of them. A comprehensive discussion of calcium-modifying techniques was elaborated, summarizing their mechanism of action, pros and cons, and possible complications. Finally, an integrated algorithm was proposed for the best management of calcified coronary lesions.

Extracorporeal shockwave lithotripsy in the management of urinary stones: New concepts and techniques to improve outcomes.

Objective: Extracorporeal shockwave lithotripsy (SWL) currently plays an important role in the treatment of urinary tract lithiasis. The purpose of this article was to describe new concepts and procedural strategies that would improve results using SWL as a treatment for urolithiasis, thereby achieving better clinical practice. Methods: A systematic review process was carried in PubMed/PMC from January 2003 to March 2023. A narrative synthesis of the most important aspects has been made. Results: The important recommendations for the adequate selection of the candidate patient for treatment with SWL are summarized, as well as the new strategies for a better application of the technique. Aspects about intraoperative position, stone localization and monitoring, analgesic control, machine and energy settings, and measures aiming at reduced risk of complications are described. Conclusion: To achieve the therapeutic goal of efficient stone disintegration without increasing the risk of complications, it is necessary to make an adequate selection of patients and to pay special attention to several important factors in the application of treatment. Technological development in later generation devices will help to improve current SWL results.

Flexible ureteroscopic treatment of kidney stones: How do the new laser systems change our concepts?

Objective: Flexible ureteroscopy (fURS) has become a widely accepted and effective technique for treating kidney stones. With the development of new laser systems, the fURS approach has evolved significantly. This literature review aims to examine the current state of knowledge on fURS treatment of kidney stones, with a particular focus on the impact of the latest laser technologies on clinical outcomes and patient safety. Methods: We conducted a search of the PubMed/PMC, Web of Science Core Collection, Scopus, Embase (Ovid), and Cochrane Databases for all randomized controlled trial articles on laser lithotripsy in September 2023 without time restriction. Results: We found a total of 22 relevant pieces of literature. Holmium laser has been used for intracavitary laser lithotripsy for nearly 30 years and has become the golden standard for the treatment of urinary stones. However, the existing holmium laser cannot completely powder the stone, and the retropulsion of the stone after the laser emission and the thermal damage to the tissue have caused many problems for clinicians. The introduction of thulium fiber laser and Moses technology brings highly efficient dusting lithotripsy effect through laser innovation, limiting pulse energy and broadening pulse frequency. Conclusion: While the holmium:yttrium-aluminum-garnet laser remains the primary choice for endoscopic laser lithotripsy, recent technological advancements hint at a potential new gold standard. Parameter range, retropulsion effect, laser fiber adaptability, and overall system performance demand comprehensive attention. The ablation efficacy of high-pulse-frequency devices relies on precise targeting, which may pose practical challenges.

Unlocking the enigma: Combined percutaneous-transhepatic and endoscopic strategies for retrieval of severed Dormia basket in choledocholithiasis. A case report and literature review.

Choledocholithiasis, characterized by the presence of stones in the common bile duct, poses significant challenges in clinical management, particularly when the stones are massive. While endoscopic methods are often effective in stone removal, complications such as the impaction of foreign bodies like Dormia baskets can occur. These complications may necessitate alternative approaches, including surgical intervention, highlighting the importance of exploring innovative interventional techniques. We report on an 89-year-old patient presenting with massive choledocholithiasis, involving complete filling of the intra- and extrahepatic bile duct system with large stones up to a maximum of 2 cm. The patient underwent interventional removal of a Dormia basket (3.5Fr. Boston Scientific, USA) impacted in the common bile duct. This procedure proved challenging due to the metallic end marker of the basket perforating through the wall of the distal common bile duct, rendering it fixed. Given the complexity of the case, a parallel approach combining percutaneous transhepatic cholangiography and drainage with simultaneous endoscopy was employed to successfully extract the fixed Dormia basket. In cases of severe choledocholithiasis complicated by the impaction of foreign bodies such as Dormia baskets, innovative interventional strategies are crucial for successful management. Our case highlights the effectiveness of a parallel approach involving percutaneous transhepatic cholangiography and drainage alongside simultaneous endoscopy in safely removing the fixed foreign body from the common bile duct. This multidisciplinary approach not only offers a viable alternative to surgical intervention but also underscores the importance of collaboration between interventional radiologists and endoscopists in optimizing patient outcomes in complex biliary interventions.

The association between renal pelvis urine density and the risk of severe infectious complications in patient with symptom-free hydronephrosis after shock wave lithotripsy: a multi-center prospective study.

Finding reliable and easy-to-obtain predictors of severe infectious complications after shock wave lithotripsy (SWL) is a major clinical need, particular in symptom-free hydronephrosis. Therefore, we aim to prospectively investigate the predictive value of Hounsfield units (HU) in renal pelvis urine for the risk of severe infectious complications in patients with ureteral stones and symptom-free hydronephrosis after SWL. This multi-center prospective study was conducted from June 2020 to December 2023. The HU of renal pelvis urine was measured by non-enhanced computed tomography. The severe infectious complications included systemic inflammatory response syndrome, sepsis, and septic shock. Binary logistic regression models assessed the odds ratios (ORs) and 95% confidence intervals (CIs). Finally, 1,436 patients with ureteral stones were enrolled in this study. 8.9% (128/1,436) of patients experienced severe infectious complications after SWL treatment. After adjusting confounding variables, compared with the patients in the lowest renal pelvis urine density quartile, the OR (95% CI) for the highest quartile was 32.36 (13.32, 78.60). There was a positive linear association between the HU value of renal pelvis urine and the risk of severe infectious complications after SWL (P for trend < 0.001). Furthermore, this association was also observed stratified by age, gender, BMI, stone size, stone location and hydronephrosis grade (all P for interaction > 0.05). Additionally, the nonlinear association employed by restricted cubic splines is not statistically significant (nonlinear P = 0.256). The AUROC and 95%CI of renal pelvis urine density were 0.895 (0.862 to 0.927, P value < 0.001). The cut-off value was 12.0 HU with 78.59% sensitivity and 85.94% specificity. This multi-center prospective study demonstrated a positive linear association between HU in renal pelvis urine and the risk of severe infectious complications in patients with ureteral stones and symptom-free hydronephrosis after SWL, regardless of age, gender, BMI, stone size, stone location, and hydronephrosis grade. These findings might be helpful in the SWL treatment decision-making process.

[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.

Assessment of the incidence and risk factors of postoperative urosepsis in patients undergoing ureteroscopic lithotripsy.

Introduction: Ureteroscopic lithotripsy (URSL) is an approved, minimally invasive, low-risk procedure for urolithiasis treatment. However, some patients may develop urinary tract infection (UTI) post-procedure, eventually leading to urosepsis. Determining the predictors of infection after URSL would help identify patients at a high risk of urosepsis, thereby enabling the early implementation of effective treatment. Therefore, we aimed to establish the incidence and predictors of urosepsis after URSL. Material and methods: We assessed 231 patients who underwent URSL using a holmium laser. The incidence of urosepsis during the 30-day post-treatment period was analysed, and potential predictors of urosepsis, including patient characteristics and individual clinical factors, were examined. Results: Statistical analysis revealed that 16.88% of patients had a confirmed positive urine culture before the procedure. Post-procedure urosepsis occurred in 4.76% of patients. Univariable analysis revealed that 3 factors were significantly associated with the risk of postoperative urosepsis: double-J stent insertion before URSL, pre-operative positive urine culture, and MDR pathogen found preoperatively. In multivariable analysis, only positive urine culture remained significantly associated with the risk of urosepsis after URSL. Conclusions: Patients with positive urine culture before URSL are at significantly higher risk of urosepsis in the postoperative period. Hence, urine culture should be routinely performed before planned endoscopic urolithiasis treatment.

Extracorporeal shock wave lithotripsy, ureterolithotripsy, and percutaneous nephrolithotripsy challenges in managing spinal cord neuropathy patients. Lessons learned from a scoping review.

Introduction: We aim to review the outcomes of shock wave lithotripsy (SWL), ureteroscopy, and percutaneous nephrolithotripsy (PCNL) for renal and ureteral stones in spinal cord neuropathy patients (SNP). Material and methods: A literature search was performed on 8th March 2023 using PubMed, EMBASE, and Google Scholar with no date limit. Preclinical/animal studies, reviews, letters to the editor, case reports, and meeting abstracts were excluded. Only English papers were accepted. Results: Thirty-five articles were accepted. Five studies focused on SWL, 17 on PCNL, and 6 on ureteroscopy. The remaining articles employed more than one procedure. Stone composition has shifted from struvite to the more common calcium phosphate. SWL showed a very poor stone-free rate (SFR) likely due to challenges in patient positioning, stone visualization, localization, and inability to pass fragments spontaneously. Flexible ureteroscopy and PCNL were associated with a high incidence of infectious complications, long hospital stays, high blood transfusion rate, and intensive care admissions. There were also cases of death. Both procedures were challenging due to genitourinary reconstruction, scoliosis and kyphosis, rib-cage deformity, lower limb contractures, and severe comorbidity which also affected anesthesia. SFR was lower than in non-neurological patients. Conclusions: SWL, ureterolithotripsy, and PCNL should be considered challenging procedures in SNP due to positioning issues, an increased risk of intra and peri-operative morbidity, and even mortality. Computed tomography should be recommended to assess residual fragments as it becomes imperative to minimize a re-intervention in SNP who should be preferably treated in referral centers.

Effectiveness and safety of a novel intravascular lithotripsy system for severe coronary calcification: CALCI-CRACK trial.

BACKGROUND: Intravascular lithotripsy is effective and safe for managing coronary calcification; however, available devices are limited, and complex lesions have been excluded in previous studies. This study aimed to investigate the effectiveness and safety of a novel intravascular lithotripsy system for severe calcification in a population with complex lesions. METHODS: CALCI-CRACK (ChiCTR2100052058) is a prospective, single-arm, multicenter study. The primary endpoint was the procedural success rate. Major safety endpoints included major adverse cardiovascular events (MACE) and target lesion failure (TLF) at 30 days and 6 months, and severe angiographic complications. Calcification morphology was assessed in the optical coherence tomography (OCT) subgroup. RESULTS: In total, 242 patients from 15 high-volume Chinese centers were enrolled, including 26.45% of patients with true bifurcation lesions, 3.31% with severely tortuous vessels, and 2.48% with chronic total occlusion, respectively. The procedural success rate was 95.04% (95% confidence interval 91.50-97.41%), exceeding the pre-specified performance goal of 83.4% (p<0.001). The 30-day and 6-month MACE rates were 4.13% and 4.55%, respectively. TLF rates at these time-points were 1.24% and 1.65%, respectively. Severe angiographic complications occurred in 0.42% of patients. In the OCT subgroup (n=93), 93.55% of calcified lesions were fractured, and minimal lumen area increased from 1.55 ± 0.55 mm2 to 4.91 ± 1.22 mm2 after stent implantation, with acute gain rate of 245 ± 102%. CONCLUSIONS: The novel intravascular lithotripsy system is effective and safe for managing severely calcified coronary lesions in a cohort that included true bifurcation lesions, severely tortuous vessels, and chronic total occlusion. (ChiCTR2100052058).

Feasibility and technicality of aortic valve lithotripsy-facilitate balloon valvuloplasty in patients with severe aortic stenosis unsuitable for immediate valvular replacement.

BACKGROUND: Aortic valve lithotripsy can fragment aortic valve calcium deposits and potentially restore leaflet pliability in animal model and ex-vivo, but clinical data is limited. Transcatheter aortic valve implantation (TAVR) might not be feasible as an urgent procedure in critically ill patients. Balloon valvuloplasty has the major limitation of valve recoil and inducing aortic regurgitation. AIMS: To determine the clinical feasibility of aortic valve lithotripsy-facilitated balloon valvuloplasty in patients with severe aortic stenosis unsuitable for valvular replacement. METHODS: We performed lithotripsy as adjunctive therapy to balloon aortic valvuloplasty in ten consecutive patients, most of whom were deemed unfit for TAVR. Lithotripsy of the aortic valve was performed with simultaneous inflation of one to three peripheral lithotripsy balloons to deliver ultrasound pulses. Rapid pacing was not used during lithotripsy. Aortic valve velocity, gradient, and valve area were measured before and after the procedure by echocardiogram. Transvalvular pressure gradient was recorded intra-procedurally. Periprocedural and ninety-day clinical outcomes were followed. RESULTS: Procedure was technically successful in 9 out of 10 patients and aborted in one patient due to cardiogenic shock. One patient had femoral closure device related complication. There was a statistically significant decrease in valvular gradient and increase in aortic valve area. 9 out of 10 patients recovered from acute episode and were discharged. 6 patients had improvement in NYHA class. 4 patients were subsequently able to receive TAVR. 90-day mortality occurred in 3 patients. There was no stroke or bradyarrhythmia peri-procedurally and no heart failure hospitalization at 90 days. CONCLUSION: Aortic valve lithotripsy-facilitated balloon valvuloplasty has reasonable feasibility, safety and technical reproducibility and acute clinical result. Hemodynamic effect is similar to that of balloon valvuloplasty reported in the literature. Subsequent Prognosis is not altered in critically ill patients.