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.

Characterizing Clinical Trials in Plastic and Reconstructive Surgery: A Systematic Review of ClinicalTrials.gov From 2007 to 2020.

BACKGROUND: Clinical trials form the backbone of evidence-based medicine. ClinicalTrials.gov is the world's largest clinical trial registry, and the state of clinical trials in plastic and reconstructive surgery (PRS) within that database has not been comprehensively studied. To that end, we explored the distribution of therapeutic areas that are under investigation, impact of funding on study design and data reporting, and trends in research patterns of all PRS interventional clinical trials registered with ClinicalTrials.gov. METHODS: Using the ClinicalTrials.gov database, we identified and extracted all clinical trials relevant to PRS that were submitted between 2007 and 2020. Studies were classified based on anatomic locations, therapeutic categories, and specialty topics. Cox proportional hazard was used to calculate adjusted hazard ratios (HRs) for early discontinuation and results reporting. RESULTS: A total of 3224 trials that included 372,095 participants were identified. The PRS trials grew at an annual rate of 7.9%. The therapeutic classes most represented were wound healing (41.3%) and cosmetics (18.1%). Funding for PRS clinical trials is largely provided through academic institutions (72.7%), while industry and US government constituted a minority. Industry-funded studies were more likely to be discontinued early than those funded by academics (HR, 1.89) or government (HR, 1.92) and to be nonblinded and nonrandomized. Academic-funded studies were the least likely to report results data within 3 years of trial completion (odds ratio, 0.87). CONCLUSIONS: A gulf exists in the representation of different PRS specialties among clinical trials. We highlight the role of funding source in trial design and data reporting to identify a potential source of financial waste and to stress the need for continued appropriate oversight.

Five-Year Experience with Transcystic Laparoscopic Common Bile Duct Exploration.

Background: Common bile duct (CBD) stones associated with cholecystitis can be treated by single-stage CBD exploration at the time of cholecystectomy or a two-stage approach with endoscopic stone extraction before or after cholecystectomy. The ideal management remains a matter of debate. The aim of this study is to analyze our outcomes with transcystic laparoscopic common bile duct exploration (LCBDE). Material and Methods: A retrospective review of patients who underwent transcystic LCBDE between 2015 and 2019 was performed. Results: A total of 106 patients underwent transcystic LCBDE over 5 years. We performed 1192 laparoscopic cholecystectomies with cholangiograms from March 2015 to December 2019. Fifteen patients had a preoperative endoscopic retrograde cholangiopancreatography (ERCP) for CBD stones seen on magnetic resonance cholangiopancreatography that during laparoscopic cholecystectomy with intraoperative cholangiogram (IOC), there were stones and/or sludge found in the CBD, which required clearance through a transcystic approach. Of the 91 patients who did not have a preoperative ERCP, clearance of the CBD was successful through a transcystic approach in 78 patients (86%). In the 13 patients that intraoperative clearance was not achieved (n = 13, 14%), a postoperative ERCP was performed. A total of 28 patients underwent either pre- or postoperative ERCP (n = 28, 26%). Choledochotomy was not performed in any of the patients. The mean operative time was 127 minutes (127 ± 48). The mean hospital length of stay (LOS) was 4 days (3.9 ± 2.8) with a median LOS of 3 days. Complications observed include wound infection (n = 2, 2%), pancreatitis after ERCP (n = 1, 1%), pneumonia (n = 1, 1%), and right hepatic duct injury (n = 1, 1%). Conclusion: Transcystic LCBDE is an effective and safe option for treatment of CBD stones. While a transcystic approach does not guarantee clearance of the CBD, it avoids the morbidity associated with a choledochotomy and can often prevent patients from having to undergo an additional procedure.