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BACKGROUND: Aortic diameter growth in type B aortic dissection (TBAD) is associated with progressive aortic dilation, resulting in increased mortality in patients with both de novo TBAD (dnTBAD) and residual dissection after type A dissection repair (rTAAD). Preemptive thoracic endovascular aortic repair may improve mortality in patients with TBAD, although it is unclear which patients may benefit most from early intervention. In vivo hemodynamic assessment using four-dimensional (4D) flow magnetic resonance imaging (MRI) has been used to characterize TBAD patients with growing aortas. In this longitudinal study, we investigated whether changes over time in 4D flow derived true and false lumen (TL, FL) hemodynamic parameters correlate with aortic growth rate which is a marker of increased risk. METHODS: We retrospectively identified TBAD patients with baseline and follow-up 4D flow MRI at least 120 days apart. Patients with TBAD intervention before baseline or between scans were excluded. 4D flow MRI data analysis included segmentation of the TL and FL, followed by voxel-wise calculation of TL and FL total kinetic energy (KE), maximum velocity (MV), mean forward flow (FF), and mean reverse flow (RF). Changes over time (Δ) were calculated for all hemodynamic parameters. Maximal diameter in the descending aorta was measured from MR angiogram images acquired at the time of 4D flow. Aortic growth rate was defined as the change in diameter divided by baseline diameter and standardized to scan interval. RESULTS: 32 patients met inclusion criteria (age: 56.9±14.1 years, Female: 13, n=19 rTAAD, n=13 dnTBAD). Mean follow up time was 538 days (range: 135-1689). Baseline aortic diameter did not correlate with growth rate. In the entire cohort, Δ FL MV (rho=0.37, p=.04) and Δ FL RF (rho=0.45, p=0.01) correlated with growth rate. In rTAAD only, Δ FL MV (rho=0.48, p=.04) and Δ FL RF (rho=0.51, p=0.03) correlated with growth rate, while in dnTBAD only, Δ TL KE (rho=0.63, p=.02) and Δ TL MV (rho=0.69, p=.01) correlated with growth rate. CONCLUSIONS: 4D flow derived longitudinal hemodynamic changes correlate with aortic growth rate in TBAD and may provide additional prognostic value for risk stratification. 4D flow MRI could be integrated into existing imaging protocols to allow for identification of TBAD patients who would benefit from preemptive surgical or endovascular intervention.
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Background: The factors associated with unplanned higher-level re-amputation (UHRA) and one-year mortality among patients with chronic limb-threatening ischemia (CLTI) after lower extremity amputation are poorly understood. Methods: This was a single-center retrospective study of patients who underwent amputations for CLTI between 2014 and 2017. Unadjusted bivariate analyses and adjusted odds ratios (AOR) from logistic regression models were used to assess associations between pre-amputation risk factors and outcomes (UHRA and one-year mortality). Results: We obtained data on 203 amputations from 182 patients (median age 65 years [interquartile range (IQR) 57, 75]; 70.7% males), including 118 (58.1%) toe, 20 (9.9%) transmetatarsal (TMA), 37 (18.2%) below-knee (BKA), and 28 (13.8%) amputations at or above the knee. Median follow-up was 285 days (IQR 62, 1348). Thirty-six limbs (17.7%) had a UHRA, and the majority of these (72.2%) were following index forefoot amputations. Risk factors for UHRA included non-ambulatory status (AOR 6.74, 95% confidence interval (CI) 1.74-26.18; p < 0.10) and toe pressure < 30 mm Hg (AOR 4.89, 95% CI 1.52-15.78; p < 0.01). One-year mortality was 17.2% (n = 32), and risk factors included coronary artery disease (AOR 3.93, 95% CI 1.56-9.87; p < 0.05), congestive heart failure (AOR 4.90, 95% CI 1.96-12.29; p = 0.001), end-stage renal disease (AOR 7.54, 95% CI 3.10-18.34; p < 0.001), and non-independent ambulation (AOR 4.31, 95% CI 1.20-15.49; p = 0.03). Male sex was associated with a reduced odds of death at 1 year (AOR 0.37, 95% CI 0.15-0.89; p < 0.05). UHRA was not associated with one-year mortality. Conclusions: Rates of UHRA after toe amputations and TMA are high despite revascularization and one-year mortality is high among patients with CLTI requiring amputation.
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OBJECTIVE: To model the volume of water used and wasted during wet scrubs at operating room (OR) scrub sinks and identify factors for reducing water waste. BACKGROUND: Wasteful consumption of water by US healthcare systems has not been well characterized. METHODS: This is a two-component observational study. The first was an observational study of handwashing practices and water usage at scrub sinks in the OR at a single medical center. The second component was a series of two anonymous surveys of surgeons and OR staff to assess hand scrub practices and perspectives. Data from both components were used to estimate the volume of water used and wasted annually at OR scrub sinks. RESULTS: The median total volume of water wasted at OR scrub sinks for 34,554 cases over one year is 337,595.6 L (interquartile range 139,010.0;911,210.5). This represents approximately 34.2% of the total volume of water usage associated with wet scrubs (i.e.,water used during scrubbing and wasted after the conclusion of the scrub). Other pertinent findings are that attending surgeons and OR staff perform water scrubs in 25.9% of cases; there are significant differences in scrub type preferences among OR users; the median volume of water wasted in a single wet scrub at timer-controlled sinks is 10 L; and significantly more water is wasted at timer-controlled sinks than knee-operated sinks. CONCLUSIONS: OR wet scrubs are a source of enormous water waste. We identified scrub sink characteristics and OR user beliefs and behaviors as modifiable factors for water waste reduction. We encourage all institutions and OR users to carefully examine their facility characteristics and practices to implement plans that will conserve water without compromising patient safety.
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INTRODUCTION: We examined the association of socioeconomic status as defined by median household income quartile (MHIQ) with mortality and readmission patterns following open repair of acute type A aortic dissection (ATAAD) in a nationally representative registry. METHODS: Adults who underwent open repair of ATAAD were selected using the US Nationwide Readmissions Database and stratified by MHIQ. Patients were selected based on diagnostic and procedural codes. The primary endpoint was 30-d readmission. RESULTS: Between 2016 and 2019, 10,288 individuals (65% male) underwent open repair for ATAAD. Individuals in the lowest income quartile were younger (median: 60 versus 64, P < 0.05) but had greater Elixhauser comorbidity burden (5.9 versus 5.7, P < 0.05). Across all groups, in-hospital mortality was approximately 15% (P = 0.35). On multivariable analysis adjusting for baseline comorbidity burden, low socioeconomic status was associated with increased readmission at 90 d, but not at 30 d. Concomitant renal disease (odds ratio [OR], 1.68; P < 0.001), pulmonary disease (OR, 1.26; P < 0.001), liver failure (OR 1.2, P = 0.04), and heart failure (OR, 1.17; P < 0.001) were all associated with readmission at 90 d. The primary indication for readmission was most commonly cardiac (33%), infectious (16.5%), and respiratory (9%). CONCLUSIONS: In patients who undergo surgery for ATAAD, lower MHIQ was associated with higher odds of readmission following open repair. While early readmission for individuals living in the lowest income communities is likely attributable to greater baseline comorbidity burden, we observed that 90-d readmission rates are associated with lower MHIQ regardless of comorbidity burden. Further investigation is required to determine which patient-level and system-level interventions are needed to reduce readmissions in the immediate postoperative period for resource poor areas.
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Disección Aórtica , Readmisión del Paciente , Adulto , Humanos , Masculino , Femenino , Factores de Riesgo , Comorbilidad , Clase Social , Disección Aórtica/epidemiología , Disección Aórtica/cirugía , Estudios RetrospectivosRESUMEN
INTRODUCTION: Type A Aortic Dissection (TAAD) is a surgical emergency with a time-dependent rate of mortality. We hypothesized that a direct-to-operating room (DOR) transfer program for patients with TAAD would reduce time to intervention. METHODS: A DOR program was started at an urban tertiary care hospital in February 2020. We performed a retrospective study of adult patients undergoing treatment for TAAD before (n = 42) and after (n = 84) implementation of DOR. Expected mortality was calculated using the International Registry of Acute Aortic Dissection risk prediction model. RESULTS: Median time from acceptance of transfer from emergency physician to operating room arrival was 1.37 h (82 min) faster in DOR compared to pre-DOR (1.93 h vs 3.30 h, p < 0.001). Median time from arrival to operating room was 1.14 h (72 min) faster after DOR compared to pre-DOR (0.17 h vs 1.31 h, p < 0.001). In-hospital mortality was 16.2% in pre-DOR, with an observed-to-expected (O/E) ratio of 1.03 (p = 0.24) and 12.0% in the DOR group, with an O/E ratio of 0.59 (p < 0.001). CONCLUSION: Creation of a DOR program resulted in decreased time to intervention. This was associated with a decrease in observed-to-expected operative mortality. The transfer of patients with acute type A aortic dissection to centers with direct-to-OR programs may result in decreased time from diagnosis to surgery.
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Disección Aórtica , Quirófanos , Adulto , Humanos , Estudios Retrospectivos , Disección Aórtica/cirugía , Aorta/cirugía , Mortalidad Hospitalaria , Resultado del TratamientoRESUMEN
BACKGROUND: Aberrant subclavian artery (ASA) with or without Kommerell's diverticulum (KD) is a rare anatomic aortic arch anomaly that can cause dysphagia and/or life-threatening rupture. The objective of this study is to compare outcomes of ASA/KD repair in patients with a left versus right aortic arch. METHODS: Using the Vascular Low Frequency Disease Consortium methodology, a retrospective review was performed of patients ≥18 years old with surgical treatment of ASA/KD from 2000 to 2020 at 20 institutions. RESULTS: 288 patients with ASA with or without KD were identified; 222 left-sided aortic arch (LAA), and 66 right-sided aortic arch (RAA). Mean age at repair was younger in LAA 54 vs. 58 years (P = 0.06). Patients in RAA were more likely to undergo repair due to symptoms (72.7% vs. 55.9%, P = 0.01), and more likely to present with dysphagia (57.6% vs. 39.1%, P < 0.01). The hybrid open/endovascular approach was the most common repair type in both groups. Rates of intraoperative complications, death within 30 days, return to the operating room, symptom relief and endoleaks were not significantly different. For patients with symptom status follow-up data, in LAA, 61.7% had complete relief, 34.0% had partial relief and 4.3% had no change. In RAA, 60.7% had complete relief, 34.4% had partial relief and 4.9% had no change. CONCLUSIONS: In patients with ASA/KD, RAA patients were less common than LAA, presented more frequently with dysphagia, had symptoms as an indication for intervention, and underwent treatment at a younger age. Open, endovascular and hybrid repair approaches appear equally effective, regardless of arch laterality.
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Trastornos de Deglución , Divertículo , Cardiopatías Congénitas , Enfermedades Vasculares , Adolescente , Humanos , Aorta Torácica/diagnóstico por imagen , Aorta Torácica/cirugía , Aorta Torácica/anomalías , Trastornos de Deglución/etiología , Trastornos de Deglución/cirugía , Divertículo/diagnóstico por imagen , Divertículo/cirugía , Divertículo/complicaciones , Cardiopatías Congénitas/complicaciones , Arteria Subclavia/diagnóstico por imagen , Arteria Subclavia/cirugía , Arteria Subclavia/anomalías , Resultado del Tratamiento , Enfermedades Vasculares/complicaciones , Adulto , Persona de Mediana EdadRESUMEN
OBJECTIVE: The GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE; W.L. Gore & Associates, Flagstaff, Arizona) was developed to be used in combination with a self-expanding stent graft (SESG) for the internal iliac artery (IIA) bridging stent. Balloon-expandable stent grafts (BESGs) are an alternative for the IIA, offering advantages in sizing, device tracking, precision, and lower profile delivery. We compared the performance of SESG and BESG when used as the IIA bridging stent in patients undergoing EVAR with IBE. METHODS: This is a retrospective review of consecutive patients who underwent EVAR with IBE implantation at a single center from October 2016 to May 2021. Anatomic and procedural characteristics were recorded via chart review and computed tomography (CT) postprocessing software (Vitrea® v7.14). Devices were assigned to SESG vs. BESG groups based on the type of device landing into the most distal IIA segment. Analysis was performed per device to account for patients undergoing bilateral IBE. The primary endpoint was IIA patency, and secondary endpoint was IBE-related endoleak. RESULTS: During the study period, 48 IBE devices were implanted in 41 patients (mean age 71.1 years). All IBE devices were implanted in conjunction with an infrarenal endograft. There were 24 devices in each of the self-expanding internal iliac component (SE-IIC) and balloon-expandable internal iliac component (BE-IIC) groups. The BE-IIC group had smaller diameter IIA target vessels (11.6±2.0 mm vs. 8.4±1.7 mm, p<0.001). Mean follow-up was 525 days. Loss of IIA patency occurred in 2 SESG devices (8.33%) at 73 and 180 days postprocedure, and in zero BESG devices, however, this difference was not statistically significant (p=0.16). There was 1 IBE-related endoleak requiring reintervention during the study period. A BESG device required reintervention due to Type 3 endoleak at 284 days. CONCLUSIONS: There were no significant differences in outcomes between SESG and BESG when used for the IIA bridging stent in EVAR with IBE. The BESGs were associated with using 2 IIA bridging stents and were more often deployed in smaller IIA target arteries. Retrospective study design and small sample size may limit the generalizability of our findings. CLINICAL IMPACT: This series compares postoperative and midterm outcomes of self expanding stent grafts and balloon expandable stent grafts (BESG) when used as the internal iliac stent graft as part of a Gore® Excluder® Iliac Branch Endoprosthesis (IBE). With similar outcomes between the two stent-grafts, our series suggests that some of the advantages of BESG, device sizing, tracking, deployment, and profile, may be able to be leveraged without impacting the mid-term performance of the IBE.
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INTRODUCTION: Type 2 endoleak (T2EL) is the most common adverse finding on postoperative surveillance after endovascular aortic aneurysm repair (EVAR). A low rate of aneurysm-related mortality with T2EL has been established. However, the optimal management strategy and the efficacy of reintervention remain controversial. This study used data from the Vascular Quality Initiative linked to Medicare claims (VQI-Medicare) to evaluate T2LE in a real-world cohort. METHODS: This retrospective review of EVAR procedures in VQI-Medicare included patients undergoing their first EVAR procedure between 2015 and 2017. Patients with an endoleak other than T2EL on completion angiogram and those without VQI imaging follow-up were excluded. Patients without Medicare part A or part B enrollment at the time of the procedure or without 1-year complete Medicare follow-up data were also excluded. The exposure variable was T2EL, defined as any branch vessel flow detected within the first postoperative year. Outcomes of interest were mortality, reintervention, T2EL-related reintervention, post-EVAR imaging, and T2EL behavior including spontaneous resolution, aneurysm sac regression, and resolution after reintervention. The association of prophylactic branch vessel embolization (PBE) with T2EL resolution and aneurysm sac regression was also evaluated. RESULTS: In a final cohort of 5534 patients, 1372 (24.7%) had an identified T2EL and 4162 (75.2%) did not. The median age of patients with and without T2EL was 77 and 75 years, respectively. There were no differences in mortality, imaging, reintervention, or T2EL-related reintervention at 3 years after the procedure for patients with T2EL. The aneurysm sac diameter decreased by 4 mm (range: 9-0 mm decrease) in the total cohort. Patients with inferior mesenteric artery-based T2EL had the smallest decrease in aneurysm diameter (median 1 mm decrease compared with 1.5 mm for accessory renal artery-based T2EL, 2 mm for multiple feeding vessel-based T2EL, and 4 mm for lumbar artery-based T2EL; P < .001). Spontaneous resolution occurred in 73.7% of patients (n = 809). T2ELs with evidence of multiple feeding vessels were associated with the lowest rate of spontaneous resolution (n = 51, 54.9%), compared with those with a single identified feeding vessel of inferior mesenteric artery (n = 99, 60.0%), lumbar artery (n = 655, 77.7%), or accessory renal artery (n = 31, 79.5%) (P < .001). PBE was performed in 84 patients. Patients who underwent PBE and were without detectable T2EL after EVAR had the greatest rate of sac regression at follow-up (7 mm decrease) compared with baseline. CONCLUSIONS: T2EL after EVAR is associated with high rates of spontaneous resolution, low rates of aneurysm sac growth, and no evidence of increased early mortality or reintervention. PBE in conjunction with EVAR may be indicated in some circumstances.
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Aneurisma de la Aorta Abdominal , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Humanos , Anciano , Estados Unidos/epidemiología , Endofuga/diagnóstico por imagen , Endofuga/etiología , Endofuga/terapia , Incidencia , Implantación de Prótesis Vascular/efectos adversos , Factores de Riesgo , Procedimientos Endovasculares/efectos adversos , Resultado del Tratamiento , Medicare , Estudios Retrospectivos , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/cirugía , Aneurisma de la Aorta Abdominal/complicacionesAsunto(s)
Aneurisma de la Aorta Torácica , Disección Aórtica , Implantación de Prótesis Vascular , Humanos , Valor Predictivo de las Pruebas , Aorta/cirugía , Disección Aórtica/diagnóstico por imagen , Hemodinámica , Aneurisma de la Aorta Torácica/diagnóstico por imagen , Resultado del Tratamiento , Aorta TorácicaRESUMEN
OBJECTIVE: Aberrant subclavian artery (ASA) and Kommerell's diverticulum (KD) are rare vascular anomalies that may be associated with lifestyle-limiting and life-threatening complications. The aim of this study is to report contemporary outcomes after invasive treatment of ASA/KD using a large international dataset. METHODS: Patients who underwent treatment for ASA/KD (2000-2020) were identified through the Vascular Low Frequency Disease Consortium, a multi-institutional collaboration to investigate uncommon vascular disorders. We report the early and mid-term clinical outcomes including stroke and mortality, technical success, and other operative outcomes including reintervention rates, patency, and endoleak. RESULTS: Overall, 285 patients were identified during the study period. The mean patient age was 57 years; 47% were female and 68% presented with symptoms. A right-sided arch was present in 23%. The mean KD diameter was 47.4 mm (range, 13.0-108.0 mm). The most common indication for treatment was symptoms (59%), followed by aneurysm size (38%). The most common symptom reported was dysphagia (44%). A ruptured KD was treated in 4.2% of cases, with a mean diameter of 43.9 mm (range, 18.0-100.0 mm). An open procedure was performed in 101 cases (36%); the most common approach was ASA ligation with subclavian transposition. An endovascular or hybrid approach was performed in 184 patients (64%); the most common approach was thoracic endograft and carotid-subclavian bypass. A staged operative strategy was employed more often than single setting repair (55% vs 45%). Compared with endovascular or hybrid approach, those in the open procedure group were more likely to be younger (49 years vs 61 years; P < .0001), female (64% vs 36%; P < .0001), and symptomatic (85% vs 59%; P < .0001). Complete or partial symptomatic relief at 1 year after intervention was 82.6%. There was no association between modality of treatment and symptom relief (open 87.2% vs endovascular or hybrid approach 78.9%; P = .13). After the intervention, 11 subclavian occlusions (4.5%) occurred; 3 were successfully thrombectomized resulting in a primary and secondary patency of 95% and 96%, respectively, at a median follow-up of 39 months. Among the 33 reinterventions (12%), the majority were performed for endoleak (36%), and more reinterventions occurred in the endovascular or hybrid approach than open procedure group (15% vs 6%; P = .02). The overall survival rate was 87.3% at a median follow-up of 41 months. The 30-day stroke and death rates were 4.2% and 4.9%, respectively. Urgent or emergent presentation was independently associated with increased risk of 30-day mortality (odds ratio [OR], 19.8; 95% confidence interval [CI], 3.3-116.6), overall mortality (OR, 3.6; 95% CI, 1.2-11.2) and intraoperative complications (OR, 8.3; 95% CI, 2.8-25.1). Females had a higher risk of reintervention (OR, 2.6; 95% CI, 1.0-6.5). At an aneurysm size of 44.4 mm, receiver operator characteristic curve analysis suggested that 60% of patients would have symptoms. CONCLUSIONS: Treatment of ASA/KD can be performed safely with low rates of mortality, stroke and reintervention and high rates of symptomatic relief, regardless of the repair strategy. Symptomatic and urgent operations were associated with worse outcomes in general, and female gender was associated with a higher likelihood of reintervention. Given the worse overall outcomes when symptomatic and the inherent risk of rupture, consideration of repair at 40 mm is reasonable in most patients. ASA/KD can be repaired in asymptomatic patients with excellent outcomes and young healthy patients may be considered better candidates for open approaches versus endovascular or hybrid modalities, given the lower likelihood of reintervention and lower early mortality rate.
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Aneurisma , Implantación de Prótesis Vascular , Divertículo , Procedimientos Endovasculares , Accidente Cerebrovascular , Humanos , Femenino , Persona de Mediana Edad , Masculino , Endofuga/etiología , Aneurisma/diagnóstico por imagen , Aneurisma/cirugía , Aneurisma/complicaciones , Arteria Subclavia/diagnóstico por imagen , Arteria Subclavia/cirugía , Arteria Subclavia/anomalías , Procedimientos Endovasculares/efectos adversos , Accidente Cerebrovascular/etiología , Divertículo/diagnóstico por imagen , Divertículo/cirugía , Aorta Torácica/cirugía , Resultado del Tratamiento , Implantación de Prótesis Vascular/efectos adversosRESUMEN
Stanford type B aortic dissection (TBAD) is a potentially fatal condition involving a tear in the descending aorta. As TBAD can be managed with medical therapy or surgical repair, identifying predictors of adverse outcomes is important to risk-stratify patients for preemptive surgical procedures. 4D flow magnetic resonance imaging (MRI) has shown to be useful in characterizing the complex hemodynamics seen in TBAD patients and correlating flow patterns with adverse outcomes. We report a case of a 58-year-old man who presented to the hospital with acute TBAD and a large primary entry tear. He was initially managed with medical therapy due to his stable clinical status and computed tomographic angiography showing a stable dissection. However, 4D flow MRI showed high velocity flow through the entry tear, which foreshadowed the later clinical decompensation of the patient. Our case demonstrates that performing 4D flow MRI on TBAD patients is feasible and can provide valuable information in the decision to pursue medical or surgical management.
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BACKGROUND: 4D Flow MRI is a quantitative imaging technique to evaluate blood flow patterns; however, it is unclear how compressed sensing (CS) acceleration would impact aortic hemodynamic quantification in type B aortic dissection (TBAD). PURPOSE: To investigate CS-accelerated 4D Flow MRI performance compared to GRAPP-accelerated 4D Flow MRI (GRAPPA) to evaluate aortic hemodynamics in TBAD. STUDY TYPE: Prospective. POPULATION: Twelve TBAD patients, two volunteers. FIELD STRENGTH/SEQUENCE: 1.5T, 3D time-resolved cine phase-contrast gradient echo sequence. ASSESSMENT: GRAPPA (acceleration factor [R] = 2) and two CS-accelerated (R = 7.7 [CS7.7] and 10.2 [CS10.2]) 4D Flow MRI scans were acquired twice for interscan reproducibility assessment. Voxelwise kinetic energy (KE), peak velocity (PV), forward flow (FF), reverse flow (RF), and stasis were calculated. Plane-based mid-lumen flows were quantified. Imaging times were recorded. TESTS: Repeated measures analysis of variance, Pearson correlation coefficients (r), intraclass correlation coefficients (ICC). P < 0.05 indicated statistical significance. RESULTS: The KE and FF in true lumen (TL) and PV in false lumen (FL) did not show difference among three acquisition types (P = 0.818, 0.065, 0.284 respectively). The PV and stasis in TL were higher, KE, FF, and RF in FL were lower, and stasis was higher in GRAPPA compared to CS7.7 and CS10.2. The RF was lower in GRAPPA compared to CS10.2. The correlation coefficients were strong in TL (r = [0.781-0.986]), and low to strong in FL (r = [0.347-0.948]). The ICC levels demonstrated moderate to excellent interscan reproducibility (0.732-0.989). The FF and net flow in mid-descending aorta TL were significantly different between CS7.7 and CS10.2. CONCLUSION: CS-accelerated 4D Flow MRI has potential for clinical utilization with shorter scan times in TBAD. Our results suggest similar hemodynamic trends between acceleration types, but CS-acceleration impacts KE, FF, RF, and stasis more in FL. EVIDENCE LEVEL: 1 Technical Efficacy: Stage 2.
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Disección Aórtica , Angiografía por Resonancia Magnética , Humanos , Angiografía por Resonancia Magnética/métodos , Estudios Prospectivos , Reproducibilidad de los Resultados , Velocidad del Flujo Sanguíneo/fisiología , Imagen por Resonancia Magnética/métodos , Disección Aórtica/diagnóstico por imagen , Hemodinámica , Imagenología Tridimensional/métodosRESUMEN
BACKGROUND: Implanted devices undergo clinical trials to assess their safety and effectiveness. However, pivotal device trials are limited in their follow-up while postmarket surveillance may incompletely capture late failure. Linking clinical trials to Medicare claims can address these limitations. This study matched patients from investigational device exemption (IDE) clinical trials for endovascular aortic aneurysm repair (EVAR) to Medicare claims-based registry data to compare long-term device outcomes between the 2 sources. METHODS: Patient-level data from 2 industry-sponsored IDE trials of EVAR devices was provided by a single industry partner. Trial data were matched at the patient level to data from the Vascular Implant Surveillance and Interventional Outcomes Network (VISION), a registry that is a part of the Society for Vascular Surgery Patient Safety Organization. The primary outcomes analyzed were survival and freedom from aneurysm-related reintervention. RESULTS: Of 159 clinical trial patients, 134 were eligible for claims-based matching and 115 (85.5%) were successfully matched to VISION registry data. For the matched cohort, the Kaplan-Meier estimated survival was 94.8% at 1 year, 82.6% at 3 years, and 68.1% at 5 years. Estimates for freedom from reintervention were 90% at 1 year, 82.4% at 3 years, and 78.1% at 5 years. The estimates for survival were nearly identical between the clinical trial data and that found in the VISION data (log-rank P = 0.89). Freedom from reintervention was similar between the groups, with IDE trial reported freedom from reintervention of 87.3% and 73.3%, compared to VISION of 92.6% and 83% at 1 and 5 years, respectively (log-rank P = 0.13). CONCLUSIONS: Clinical trial patients who undergo EVAR can be successfully matched to claims-based registry data to improve long-term device surveillance and outcomes reporting. Claims-based results agreed well with IDE trial results for patients through 5 years, supporting the accuracy of claims-based data for longer-term surveillance. Linking clinical trial and claims-based registry data can lead to robust device monitoring.
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Aneurisma de la Aorta Abdominal , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Anciano , Humanos , Estados Unidos , Aneurisma de la Aorta Abdominal/cirugía , Complicaciones Posoperatorias , Datos de Salud Recolectados Rutinariamente , Resultado del Tratamiento , Medicare , Prótesis Vascular , Factores de Riesgo , Estudios RetrospectivosRESUMEN
OBJECTIVE: To evaluate long term outcomes (reintervention and late rupture of abdominal aortic aneurysm) of aortic endografts in real world practice using linked registry claims data. DESIGN: Observational surveillance study. SETTING: 282 centers in the Vascular Quality Initiative Registry linked to United States Medicare claims (2003-18). PARTICIPANTS: 20 489 patients treated with four device types used for endovascular abdominal aortic aneurysm repair (EVAR): 40.6% (n=8310) received the Excluder (Gore), 32.2% (n=6606) the Endurant (Medtronic), 16.0% (n=3281) the Zenith (Cook Medical), and 11.2% (n=2292) the AFX (Endologix). Given modifications to AFX in late 2014, patients who received the AFX device were categorized into two groups: the early AFX group (n=942) and late AFX group (n=1350) and compared with patients who received the other devices, using propensity matched Cox models. MAIN OUTCOME MEASURES: Reintervention and rupture of abdominal aortic aneurysm post-EVAR; all patients (100%) had complete follow-up via the registry or claims based outcome assessment, or both. RESULTS: Median age was 76 years (interquartile range (IQR) 70-82 years), 80.0% (16 386/20 489) of patients were men, and median follow-up was 2.3 years (IQR 0.9-4.1 years). Crude five year reintervention rates were significantly higher for patients who received the early AFX device compared with the other devices: 14.9% (95% confidence interval 13.7% to 16.2%) for Excluder, 19.5% (18.1% to 21.1%) for Endurant, 16.7% (15.0% to 18.6%) for Zenith, and early 27.0% (23.7% to 30.6%) for the early AFX. The risk of reintervention for patients who received the early AFX device was higher compared with the other devices in propensity matched Cox models (hazard ratio 1.61, 95% confidence interval 1.29 to 2.02) and analyses using a surgeon level instrumental variable of >33% AFX grafts used in their practice (1.75, 1.19 to 2.59). The linked registry claims surveillance data identified the increased risk of reintervention with the early AFX device as early as mid-2013, well before the first regulatory warnings were issued in the US in 2017. CONCLUSIONS: The linked registry claims surveillance data identified a device specific risk in long term reintervention after EVAR of abdominal aortic aneurysm. Device manufacturers and regulators can leverage linked data sources to actively monitor long term outcomes in real world practice after cardiovascular interventions.
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Aneurisma de la Aorta Abdominal , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Masculino , Humanos , Anciano , Estados Unidos/epidemiología , Anciano de 80 o más Años , Femenino , Aneurisma de la Aorta Abdominal/epidemiología , Aneurisma de la Aorta Abdominal/cirugía , Implantación de Prótesis Vascular/efectos adversos , Prótesis Vascular , Procedimientos Endovasculares/efectos adversos , Stents , Resultado del Tratamiento , Estudios Retrospectivos , Medicare , Sistema de Registros , Factores de RiesgoRESUMEN
Purpose: The purpose of our study was to assess the value of true lumen and false lumen hemodynamics compared to aortic morphological measurements for predicting adverse-aorta related outcomes (AARO) and aortic growth in patients with type B aortic dissection (TBAD). Materials and Methods: Using an IRB approved protocol, we retrospectively identified patients with descending aorta (DAo) dissection at a large tertiary center. Inclusion criteria includes known TBAD with ≥ 6 months of clinical follow-up after initial presentation for TBAD or after ascending aorta intervention for patients with repaired type A dissection with residual type B aortic dissection (rTAAD). Patients with prior descending aorta intervention were excluded. The FL and TL of each patient were manually segmented from 4D flow MRI data, and 3D parametric maps of aortic hemodynamics were generated. Groups were divided based on (1) presence vs. absence of AARO and (2) growth rate ≥ vs. < 3 mm/year. True and false lumen kinetic energy (KE), stasis, peak velocity (PV), reverse/forward flow (RF/FF), FL to TL KE ratio, as well as index aortic diameter were compared between groups using the Mann-Whitney U or independent t-test. Results: A total of n = 51 patients (age: 58.4 ± 15.0 years, M/F: 31/20) were included for analysis of AARO. This group contained n = 26 patients with TBAD and n = 25 patients with rTAAD. In the overall cohort, AARO patients had larger baseline diameters, lower FL-RF, FL stasis, TL-KE, TL-FF and TL-PV. Among patients with de novo TBAD, those with AAROs had larger baseline diameter, lower FL stasis and TL-PV. In both the overall cohort and in the subgroup of de novo TBAD, subjects with aortic growth ≥ 3mm/year, patients had a higher KE ratio. Conclusion: Our study suggests that 4D flow MRI is a promising tool for TBAD evaluation that can provide information beyond traditional MRA or CTA. 4D flow has the potential to become an integral aspect of TBAD work-up, as hemodynamic assessment may allow earlier identification of at-risk patients who could benefit from earlier intervention.
RESUMEN
OBJECTIVE: The widespread application of endovascular abdominal aortic aneurysm repair (EVAR) has ushered in an era of requisite postoperative surveillance and the potential need for reintervention. The national prevalence and results of EVAR conversion to open repair, however, remain poorly defined. The purpose of this analysis was to define the incidence of open conversion and its associated outcomes. METHODS: The SVS Vascular Quality Initiative EVAR registry linked to Medicare claims via Vascular Implants Surveillance and Interventional Outcomes Network was queried for open conversions after initial EVAR procedures from 2003 to 2016. Cumulative conversion incidence within up to 5 years after EVAR and outcomes after open intervention were determined. Multivariable logistic regressions were used to identify independent predictors of conversion and mortality. RESULTS: Among 15,937 EVAR patients, 309 (1.9%) underwent an open conversion: 43% (n = 132) early (<30 days) and 57% (n = 177) late (>30 days). The longitudinally observed rate of conversion was constant over time, as well as by geographic region. Independent predictors of conversion included female sex (hazard ratio [HR], 1.49; P < .001), aneurysm diameter or more than 6.0 cm at the time of index EVAR (HR, 1.74; P < .001), nonelective repair (compared with elective presentation: HR, 1.72; P < .001), and aortouni-iliac repairs (HR, 2.19; P < .001). In contrast, adjunctive operative procedures such as endo-anchors or cuff extensions (HR, 0.62; P = .06) were protective against long-term conversion. Both early (HR, 1.6; P < .001) and late (HR, 1.26; P = .07) open conversions were associated with significant 30-day (total cohort, 15%) and 1-year mortality (total cohort, 25%). Patients undergoing open conversion experienced high rates of 30-day readmission (42%) and cardiac (45%), renal (32%), and pulmonary (30%) complications. CONCLUSIONS: This large, registry-based analysis is among the first to document the incidence and outcomes for open conversion after EVAR in a national cohort with long-term follow-up. Importantly, women, patients with large aneurysms, and complex anatomy, as well as urgent or emergent EVARs are at an increased risk for open conversion. It seems that more conversions are performed in the early postoperative period, despite perceptions that conversion is a delayed phenomenon. In all instances, conversion is associated with significant morbidity and mortality and highlights the importance of appropriate patient selection at the time of index EVAR.
Asunto(s)
Aneurisma de la Aorta Abdominal , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Anciano , Aneurisma de la Aorta Abdominal/complicaciones , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/cirugía , Femenino , Humanos , Incidencia , Medicare , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/terapia , Estudios Retrospectivos , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento , Estados Unidos/epidemiologíaRESUMEN
BACKGROUND: Acute aortic syndromes comprise a spectrum of diseases including aortic dissection, intramural hematoma, and penetrating atherosclerotic ulcers. Early diagnosis, rapid intervention, and multidisciplinary team care are vital to efficiently manage time-sensitive aortic emergencies, mobilize appropriate resources, and optimize clinical outcomes. OBJECTIVE: This comprehensive review outlines the multidisciplinary team approach from initial presentation to definitive interventional treatment and post-operative care. DISCUSSION: Acute aortic syndromes can be life-threatening and require prompt diagnosis and aggressive initiation of blood pressure and pain control to prevent subsequent complications. Early time to diagnosis and intervention are associated with improved outcomes. CONCLUSIONS: A multidisciplinary team can help promptly diagnose and manage aortic syndromes.
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Enfermedades de la Aorta/diagnóstico , Disección Aórtica/diagnóstico , Hematoma/diagnóstico , Úlcera/diagnóstico , Enfermedad Aguda , Disección Aórtica/terapia , Enfermedades de la Aorta/terapia , Presión Sanguínea , Hematoma/terapia , Humanos , Manejo del Dolor , Grupo de Atención al Paciente , Síndrome , Cirugía Torácica , Úlcera/terapia , Procedimientos Quirúrgicos VascularesRESUMEN
OBJECTIVE: An individual's understanding of disease risk factors and outcomes is important for the ability to make healthy lifestyle choices and decisions about disease treatment. Peripheral artery disease (PAD) is a condition with increasing global prevalence and high risk of adverse patient outcomes. This study seeks to understand the adequacy of disease understanding in patients with PAD. METHODS: This was an observational study of patients with PAD recruited from vascular surgery outpatient clinic and PAD clinical studies at a single academic medical center over an 8-month period. A 44-item paper survey assessed demographic and socioeconomic information, knowledge of personal medical history, PAD risk factors, consequences of PAD, and health education preferences. Patients with documented presence of PAD were offered the survey. Patients unable to complete the survey or provide informed consent were not considered eligible. Disease "awareness" was defined as correct acknowledgement of the presence or absence of a disease, including PAD, in the personal medical history. "PAD knowledge score" was the percentage of correct responses to questions on general PAD risk factors and consequences. Of 126 eligible patients, 109 participated. Bivariate analysis was used to study factors associated with awareness of PAD diagnosis. Factors associated with the PAD knowledge score were studied using the Pearson correlation coefficient, two-sample t test, or one-way analysis of variance. P value < .05 was considered statistically significant. RESULTS: The mean participant age was 69.4 ± 11.0 years, and 39.4% (n = 43) were female. Most participants (78.9%; n = 86) had critical limb-threatening ischemia. Only 65.4% (n = 70) of participants were aware of a diagnosis of PAD, which was less than their awareness of related comorbidities. Factors positively associated with PAD diagnosis awareness were female sex (81.4% vs 54.7%; P = .004) and history of percutaneous leg revascularization (78.6% vs 47.9%; P = .001). Among 17 patients who had undergone major leg amputation, 35% (n = 6) were unaware of a diagnosis of PAD. PAD knowledge scores correlated positively with an awareness of PAD diagnosis (59.1% vs 48.7%; P = .02) and negatively with a history of hypertension (53.4% vs 68.1%; P = .001). Most participants (86.5%; n = 90) expressed a desire to be further educated on PAD. The most popular education topics were dietary recommendations, causes, and treatment for PAD. CONCLUSIONS: Patients with PAD have deficits in their awareness of this diagnosis and general knowledge about PAD. Future research priorities should further define these deficits and their causes in order to inform new strategies that foster information-seeking behavior and effective educational programs for PAD.