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This Viewpoint proposes several ways to innovate electronic health record (EHR) systems to address surgeon-specific needs and to improve clinicians' experience and health care quality.
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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.
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Estenosis Carotídea , Litotricia , Stents , Calcificación Vascular , Humanos , Masculino , Femenino , Anciano , Calcificación Vascular/terapia , Calcificación Vascular/diagnóstico por imagen , Calcificación Vascular/complicaciones , Litotricia/efectos adversos , Estudios Retrospectivos , Resultado del Tratamiento , Factores de Riesgo , Anciano de 80 o más Años , Estenosis Carotídea/terapia , Estenosis Carotídea/diagnóstico por imagen , Estenosis Carotídea/complicaciones , Factores de Tiempo , Índice de Severidad de la Enfermedad , Accidente Cerebrovascular/etiología , Medición de Riesgo , Estados Unidos , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/instrumentaciónRESUMEN
BACKGROUND: Since the risk of mortality from rupture is elevated, elective repair of abdominal aortic aneurysms (AAAs) is often recommended. Currently, over 80% of elective repairs are carried out using an endovascular approach. While open repair has similar late survival and fewer reintervention outcomes when compared to endovascular repair, incisional hernia is a frequent complication with morbidity and cost implications. The Open versus Endovascular Repair (OVER) trial was the largest randomized trial of endovascular versus open repair of AAA in the United States. The purpose of this study was to determine risk factors associated with incisional hernia development following AAA repair via secondary analysis of the OVER data. METHODS: This was a multisite trial conducted within the Veterans Affairs health-care system. Study participants (N = 881) were enrolled from 2002 to 2008 and followed until 2011 with additional administrative data collection until 2016. Eligible patients had AAA for which elective repair was planned and randomized 1:1 to either open or endovascular repair. Incisional hernia was a prespecified end point in the OVER protocol, specifically assessed at each protocol follow-up visit. Technical details were extracted from each operative report, repair case report form(s), and adverse event form(s). Patient demographics, comorbid conditions, reported preoperative activity level, and operative details including initial approach, blood loss, and closure methods were analyzed using Bayesian hierarchical Weibull survival regression modeling. RESULTS: Incisional hernias were recorded among 46 participants (5.2%). The average time to hernia diagnosis was 3.5 years. Of the 437 participants randomized to open treatment, 427 received an open repair including crossovers from endovascular treatment assignment. Transperitoneal repair was performed in 81%, running suture in 96%, and absorbable suture in 71% of cases. Randomization to endovascular repair was associated with reduced risk of hernia (hazard ratio [HR] 0.70, 95% credible interval [CI] 0.49-0.94). Higher activity level was associated with increased hernia risk (HR 1.39, 95% CI 1.06-1.84). Approach, suture closure techniques, body mass index, diabetes, and smoking status were not associated with increased risk of hernia development. CONCLUSIONS: Incisional hernia is a frequent complication associated with open repair of abdominal aortic aneurysm and commonly required reintervention. Endovascular repair was associated with reduced risk of hernia. Patients with increased activity experienced a higher incidence of hernia. However, no other modifiable patient, operative, or technical factors were found to be associated with hernia development.
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Aneurisma de la Aorta Abdominal , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Hernia Incisional , Humanos , Factores de Riesgo , Masculino , Aneurisma de la Aorta Abdominal/cirugía , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/mortalidad , Anciano , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/mortalidad , Femenino , Hernia Incisional/cirugía , Hernia Incisional/etiología , Resultado del Tratamiento , Factores de Tiempo , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/mortalidad , Medición de Riesgo , Estados Unidos/epidemiología , Persona de Mediana Edad , Anciano de 80 o más AñosRESUMEN
OBJECTIVE: Restenosis after transcarotid artery revascularization (TCAR) is a known complication. When identified in the early postoperative period, it may be related to technique. We evaluated our TCAR experience to identify potentially modifiable factors impacting restenosis. METHODS: This is a single-institution, retrospective review of patients undergoing TCAR from November 2017 to July 2022. Restenosis was defined as >50% stenosis on duplex ultrasound (DUS) examination or computed tomographic angiography (CTA). Continuous variables were compared using Kruskal-Wallis's test. Categorical variables were compared using the Fisher's exact test. RESULTS: Of 61 interventions, 11 (18%) developed restenosis within the median follow-up of 345 days (interquartile range, 103-623 days). Among these patients, 82% (9/11) had >50% stenosis, and 18% (2/11) had >80% stenosis. Both patients with high-grade restenosis were symptomatic and underwent revascularization. Diagnosis of post-TCAR restenosis was via DUS examination in 45% (5/11), CTA in 18% (2/11), or both CTA/DUS examination in 36% (4/11). Restenosis occurred within 1 month in 54% (6/11) and 6 months in 72% (8/11) of patients. However, three of the six patients with restenosis within 1 month had discordant findings on CTA vs DUS imaging. Patient comorbidities, degree of preoperative stenosis, medical management, balloon size, stent size, lesion characteristics, and predilatation angioplasty did not differ. Patients with restenosis were younger (P = .02), had prior ipsilateral endarterectomy (odds ratio [OR], 6.5; P = .02), had history of neck radiation (OR, 18.3; P = .01), and lower rate of postdilatation angioplasty (OR, 0.11; P = .04), without an increased risk of neurological events. CONCLUSIONS: Although post-TCAR restenosis occurred in 18% of patients, only 3% of patients had critical restenosis and required reintervention. Patient factors associated with restenosis were younger age, prior endarterectomy, and history of neck radiation. Although early restenosis may be mitigated by improved technique, the only technical factor associated with restenosis was less use of postdilatation angioplasty. Balancing neurological risk, this factor may have increased application in appropriate patients. Diagnosis of restenosis was inconsistent between imaging modalities; current surveillance paradigms and diagnostic thresholds may warrant reconsideration.
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Estenosis Carotídea , Accidente Cerebrovascular , Humanos , Estenosis Carotídea/diagnóstico por imagen , Estenosis Carotídea/cirugía , Constricción Patológica/complicaciones , Resultado del Tratamiento , Factores de Riesgo , Arterias , Estudios Retrospectivos , Stents/efectos adversos , Accidente Cerebrovascular/etiología , Medición de RiesgoRESUMEN
INTRODUCTION: As part of the 21st Century Cures Act (April 2021), electronic health information (EHI) must be immediately released to patients. In this study, we sought to evaluate clinician and patient perceptions regarding this immediate release. METHODS: After surveying 33 clinicians and 30 patients, semi-structured interviews were conducted with a subset of the initial sample, comprising 8 clinicians and 12 patients. Open-ended questions explored clinicians' and patients' perceptions of immediate release of EHI and how they adjusted to this change. RESULTS: Ten themes were identified: Interpreting Results, Strategies for Patient Interaction, Patient Experiences, Communication Strategies, Provider Limitations, Provider Experiences, Health Information Interfaces, Barriers to Patient Understanding, Types of Results, and Changes due to Immediate Release. Interviews demonstrated differences in perceived patient distress and comprehension, emphasizing the impersonal nature of electronic release and necessity for therapeutic clinician-patient communication. CONCLUSIONS: Clinicians and patients have unique insights on the role of immediate release. Understanding these perspectives will help improve communication and develop patient-centered tools (glossaries, summary pages, additional resources) to aid patient understanding of complex medical information.