Conventional ultrasonography enabled with augmented reality needle guidance for percutaneous kidney access: An innovative methodologies randomized controlled trial.
Successful needle puncture of the renal collecting system is a critical but difficult procedure in percutaneous nephrolithotomy (PCNL). Although fluoroscopy and ultrasound are the standard imaging techniques to guide puncture during PCNL, both have known limitations.
To assess the feasibility and safety of a new navigation system for needle puncture in ultrasound-guided PCNL.
This study employed a single-center randomized controlled trial (RCT) design to assess the feasibility and safety of a new navigation system for needle puncture in ultrasound-guided PCNL. Conducted between May 2021 and November 2021, the trial utilized computer-generated random numbers for participant allocation to control for selection bias.
The trial was executed at the *********, which serves as an academic medical center.
All patients who met the inclusion criteria were randomly divided into two groups, with 29 patients in each group. One group underwent PCNL procedures using the new navigation system, while the control group underwent standard ultrasound-guided PCNL procedures. Included patients had renal pelvis or caliceal calculi larger than 2.0 cm in diameter or had multiple or staghorn stones. The puncture procedure was performed with the support of real-time ultrasound imaging and visual guidance displayed on the screen.
The primary outcome was system feasibility and puncture success rate. Secondary outcomes included puncture time, total surgical time, number of attempts, post-procedure complications, and one-year and three-year stone recurrence rates. Stone clearance was defined by postoperative CT. Descriptive statistics summarized patient demographics, stone size, and location. Independent samples t-tests analyzed puncture time and total surgical time. Chi-square or Fisher's exact tests compared stone clearance, complications, socioeconomic status, renal hydronephrosis, stone location, race, and medical history. Linear regression examined the correlation between BMI and puncture time. Significance was set at P<0.05.
For all 58 patients undergoing PCNL, needle punctures of the renal collecting system were completed with a success rate of 100%. The average time from planning the puncture protocol to successful puncture was significantly shorter in the AcuSee guidance system group (3.12 min, range 0.2-6.88 min) compared to the standard ultrasound-guided group (7.58 min, range 5.41-10.68 min), representing a reduction of approximately 59%. The total surgical time was also shorter in the AcuSee group for patients with no and mild hydronephrosis (P<0.05). Complication rates were lower in the AcuSee group, with no major complications observed. However, 3 patients in the standard ultrasound-guided group have adverse effects after the PCNL procedure. The one-year stone recurrence rate was significantly lower in the AcuSee group (3.4%) compared to the standard group (24.1%), and the three-year recurrence rate was also lower (6.9% vs. 41.4%). Patient-specific factors such as BMI, renal morphology, and prior surgical history did not significantly affect the performance of the AcuSee system.
We report the first clinical application of a new navigation system for needle puncture in ultrasound-guided PCNL. It has been demonstrated that it is feasible and safe compared to the standard ultrasound-guided group in percutaneous renal puncture. This technology provides intuitive and easy-to-use visual guidance, which may facilitate safe, accurate and fast needle puncture of the kidney.
Xu C
，Li A
，Peng Y
，Li L
，Xiong G
，Fan Y
，Zhao Z
，Li X
，Zhang X
，Zheng Y
，Zhang C
，Lv C
，Li X
，Wang G
，Xia Y
，Wang P
，Yao L
... -
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Ultrasound-guided versus anatomic landmark-guided percutaneous femoral artery access.
The use of percutaneous arterial access for endovascular procedures has broad applications, from diagnostic angiography in the coronary and peripheral arteries, to thromboembolectomy in people with ischemic stroke and percutaneous coronary intervention in those with acute myocardial infarction. The rise of these procedures worldwide underscores the importance of obtaining precise and timely arterial access while minimizing the risk of adverse events. Traditionally, anatomic landmarks, such as the anterior superior iliac spine and symphysis pubis, have guided percutaneous common femoral artery (CFA) access, along with manual palpation of the pulse and fluoroscopy to confirm bony landmarks. Anatomic landmarks can be deceptive, however, especially in certain subpopulations, such as those with a high femoral artery bifurcation, elevated body mass index (BMI), or non-palpable femoral pulses. Ultrasound has emerged as a promising tool to guide percutaneous CFA access, offering enhanced visualization and providing real-time guidance. Notwithstanding this theoretical advantage, trials have inconsistently demonstrated an advantage to ultrasound guidance over anatomic landmarks, and concerns surrounding added set-up time and training have limited its uptake both clinically and across society guidelines.
To assess the efficacy and safety of ultrasound compared to anatomic landmarks to guide percutaneous access of the CFA for the purpose of endovascular arterial imaging or treatment.
The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, and CINAHL databases and World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 25 January 2024.
We selected randomized controlled trials comparing ultrasound guidance to anatomic landmark guidance (using manual palpation or fluoroscopy, or both) for percutaneous CFA access in people undergoing endovascular therapy for diagnostic or therapeutic purposes.
We used standard Cochrane methods. Primary outcomes included first-pass success, time to successful CFA access, and major bleeding (including hematoma requiring transfusion, hematoma extending length of stay, hematoma ≥ 5 cm, unexplained hemoglobin drop, or major/severe bleeding as defined by each trial). Secondary outcomes included overall cannulation success, venipuncture, pain scores, number of access attempts, major complications (including retroperitoneal hematoma, pseudoaneurysms, dissections, arteriovenous fistulae, or occlusions), adverse events (including minor bleeding, infection, and neuropathy) up to 30 days, quality of life, re-intervention rate up to 30 days, and total number of access sites attempted. We conducted sensitivity analyses to determine whether the effect of ultrasound guidance on time to successful CFA access differed across studies that defined this endpoint differently, and to assess the impact of studies that permitted rescue ultrasound on study endpoints.
Of 1422 records identified through our search of the databases, nine randomized controlled trials enrolling 4447 participants fulfilled our inclusion criteria. All trials were at high risk of bias in at least one domain, with seven trials at overall high risk of bias and the remaining two at overall unclear risk of bias. There may be increased first-pass success (odds ratio [OR] 3.35, 95% confidence interval [CI] 2.53 to 4.44; P < 0.001, I² = 69%; 7 trials, 4274 participants; low certainty evidence) and reduced time to successful CFA access (mean difference [MD] -17.24 s, 95% CI -27.04 to -7.43 s; P < 0.001, I² = 45%; 6 trials, 3570 participants; low certainty evidence) with ultrasound guidance compared to anatomic landmark guidance. Ultrasound guidance may also reduce unintentional venipuncture (OR 0.26, 95% CI 0.18 to 0.38; P < 0.001, I² = 33%; 7 trials, 4178 participants; low certainty evidence) and number of access attempts (MD -0.59, 95% CI -0.91 to -0.26; P < 0.001, I² = 96%; 5 trials, 3362 participants; very low certainty evidence), although the evidence for the latter outcome is very uncertain. Ultrasound guidance may have little to no effect on major bleeding (OR 0.60, 95% CI 0.32 to 1.13; P = 0.11, I² = 38%; 6 trials, 4016 participants; low certainty evidence), overall cannulation success (though the evidence is very uncertain) (OR 1.46, 95% CI 0.93 to 2.30; P = 0.10, I² = 59%; 4 trials, 2520 participants; very low certainty evidence), and likely has little to no effect on pain scores (MD 0.00, 95% CI -0.34 to 0.34; P = 1.00, I² not applicable; 1 trial, 939 participants; moderate certainty evidence). Ultrasound guidance may also have little to no effect on retroperitoneal hematoma, pseudoaneurysm formation, arterial dissection, arteriovenous fistulae, target vessel occlusion, minor bleeding, or infection compared to anatomic landmark guidance (P > 0.05 for all). Lack of data precluded an assessment of re-intervention rates, neuropathy, quality of life, or number of access sites. Sensitivity analysis revealed that ultrasound guidance may reduce time to successful CFA access in studies that defined this outcome as time from administration of local anesthetic to successful sheath insertion (MD -23.65 s, 95% CI -34.28 to -13.01 s; 3 trials, 1517 participants), but not in studies that defined it as time from the first movement of the fluoroscopy table/application of the ultrasound probe to successful sheath insertion (MD -14.85 s, 95% CI -33.45 to 3.75 s; 2 trials, 1941 participants) or time from skin penetration by the access needle to sheath insertion (MD 11.00 s, 95% CI -43.06 to 65.06 s; 1 trial, 112 participants). Sensitivity analysis excluding studies that permitted rescue ultrasound resulted in no change in the overall effect of ultrasound versus anatomic landmark guidance on any of the observed outcomes.
Ultrasound guidance may confer clinical benefit over anatomic landmark guidance for percutaneous CFA access regarding first-pass success, time to successful CFA access, and unintentional venipuncture, without increasing the risk of adverse events. Evidence for other outcomes including major bleeding, overall cannulation success, number of access attempts, retroperitoneal hematoma, minor bleeding, pseudoaneurysms, arterial dissection, arteriovenous fistulae, arterial occlusion, infection, or pain scores demonstrates no benefit to ultrasound guidance over anatomic landmark guidance. Data on higher-risk subgroups, including people with elevated BMI, extensive atherosclerosis or calcification, and high femoral artery bifurcation, are lacking. Generalizability was also limited by the high risk of bias across most studies and the exclusion of important subgroups (e.g. people with non-palpable pulses).
Strauss SA
，Ma GW
，Seo C
，Siracuse JJ
，Madassery S
，Truesdell AG
，Pereira K
，Korngold EC
，Kayssi A
... -
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