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1.
J Vasc Surg ; 2024 May 14.
Article in English | MEDLINE | ID: mdl-38750944

ABSTRACT

BACKGROUND: Thoracic endovascular aortic repair (TEVAR) represents optimal therapy for complicated acute type B aortic dissection (aTBAD). Persistent knowledge gaps remain, including the optimal length of aortic coverage, impact on distal aortic remodeling, and fate of the dissected abdominal aorta. METHODS: Review of the Emory Aortic Database identified 92 patients who underwent TEVAR for complicated aTBAD from 2012 to 2018. Standard TEVAR covered aortic zones 3 and 4 (from the left subclavian to the mid-descending thoracic aorta). Extended TEVAR fully covered aortic zones 3 though 5 (from the left subclavian to the celiac artery). Long-term imaging, clinical follow-up, and overall and aortic-specific mortality were reviewed. RESULTS: Extended TEVAR (n = 52) required a greater length of coverage vs standard TEVAR (n = 40) (240 ± 32 mm vs 183 ± 23 mm; P < .01). In-hospital mortality occurred in 5.4% of patients (7.7% vs 2.5%; P = .27) owing to mesenteric malperfusion (n = 3) or rupture (n = 2). The overall incidences of postoperative stroke, transient paraparesis, paraplegia, and dialysis were 5.4% (3.9% vs 7.5%; P = .38), 3.2% (5.8% vs 0%; P = .18), 0%, and 0% respectively, equivalent between groups. Follow-up was 96.6% complete to a mean of 6.1 years (interquartile range, 3.5-8.6 years). There were significantly higher rates of complete thrombosis or obliteration of the entire thoracic false lumen after Extended TEVAR (82.2% vs 51.5%; P = .04). Distal aortic reinterventions were less frequent after extended TEVAR (5.8% vs 20%; P = .04). Late aorta-specific survival was 98.1% after extended TEVAR vs 92.3% for standard TEVAR (P = .32). CONCLUSIONS: Extended TEVAR for complicated aTBAD is safe, results in a high rate of total thoracic false lumen thrombosis/obliteration, and reduces distal reinterventions. Longer-term follow-up will be needed to demonstrate a survival benefit compared to limited aortic coverage.

2.
J Vasc Surg ; 2024 Jun 24.
Article in English | MEDLINE | ID: mdl-38925349

ABSTRACT

OBJECTIVE: This study aimed to determine the influences of varying severity of sleep apnea syndrome (SAS) on the outcomes after thoracic endovascular aorta repair (TEVAR) in patients with Stanford type B aortic dissection (TBAD). METHODS: This observational study focused on individuals with TBAD plus SAS who received TEVAR between January 2018 and December 2022. Patients were divided into groups according to the results of the portable sleep-breathing monitoring systems: mild SAS (MSAS) and moderate-to-severe SAS (MSSAS). Clinical profiles were collected and analyzed. RESULTS: A total of 121 cases with TBAD plus SAS who underwent TEVAR were enrolled in this study. Two groups were formed by stratifying these cases: MSAS (74 cases) and MSSAS (47 cases). The MSSAS cases were found to be older relative to MSAS cases (51.7 ± 8.3 years vs 57.1 ± 12.8 years; P = .012) and had a higher body mass index (BMI; 25.7 ± 2.3 kg/m2vs 27.0 ± 2.3 kg/m2; P = .038). The investigation did not find any appreciable differences between the MSAS and MSSAS groups in terms of complications (endoleak, P = .403; stent-induced new entry, P >.999; and stent displacement: P >.999). However, the MSSAS group exhibited a significantly higher overall mortality rate compared with the MSAS group (log-rank P = .027). The tendency continued when examining cases with Marfan syndrome combined with MSSAS, where the overall mortality rate was significantly greater compared with Marfan syndrome cases with MSAS (log-rank P = .037). The absence of a significant difference was noteworthy in the freedom from reintervention between the MSAS and MSSAS groups (log-rank P = .278). The overall mortality rate was significantly higher in MSSAS group even after adjusting for varying potential confounders in the multivariate cox regression analysis (hazard ratio [HR], 1.875; 95% confidence interval [CI], 1.238-2.586; P = .012). A markedly higher rate of distal stent dilation in the MSSAS group was also observed compared with the MSAS group (HR, 2.5 mm/year [95% CI, 2-3 mm/year] vs HR, 4 mm/year [95% CI, 2.0-5.5 mm/year]; P = .029). CONCLUSIONS: MSSAS is associated with a significantly higher risk of overall mortality and dilation rate of the distal stent after TEVAR for TBAD patients. Hence, aggressive efforts to reverse the severity of SAS in time in these individuals seem to be necessary.

3.
J Vasc Surg ; 79(6): 1287-1294.e1, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38185213

ABSTRACT

OBJECTIVE: The high frequency of reinterventions after fenestrated endovascular aortic repair (FEVAR) with physician-modified endografts (PMEGs) has been well-studied. However, the impact of prior EVAR on reinterventions and sac behavior following these procedures remains unknown. We analyzed 3-year rates of reinterventions and sac dynamics following PMEG for index aneurysm repair compared with PMEG for prior EVAR with loss of proximal seal. METHODS: We performed a retrospective analysis of 122 consecutive FEVARs with PMEGs at a tertiary care center submitted to the United States Food and Drug Administration in support of an investigational device exemption trial. We excluded patients with aortic dissection (n = 5), type I to III thoracoabdominal aneurysms (n = 13), non-elective procedures (n = 4), and prior aortic surgery other than EVAR (n = 8), for a final cohort of 92 patients. Patients were divided into those who underwent PMEG for index aneurysm repair (primary FEVAR) and those who underwent PMEG for rescue of prior EVAR with loss of proximal seal (secondary FEVAR). The primary outcomes were freedom from reintervention and sac dynamics (regression as ≥5 mm decrease, expansion as ≥5 mm increase, and stability as <5 mm increase or decrease) at 3 years. Secondary outcomes were perioperative mortality and 3-year survival. RESULTS: Of the 92 patients included, 56 (61%) underwent primary FEVAR and 36 (39%) underwent secondary FEVAR. Secondary FEVAR patients were older (78 years [interquartile range (IQR), 74.5-83.5 years] vs 73 years [IQR, 69-78.5 years]; P < .001), more frequently male (86% vs 68%; P = .048), and had larger aneurysms (72.5 mm [IQR, 65.5-81 mm] vs 59 mm [IQR, 55-65 mm]; P < .001). Perioperative mortality was 1.8% for primary FEVAR and 2.7% for secondary FEVAR (P = .75). At 3 years, overall survival was 84% for primary FEVAR and 71% for secondary FEVAR (P = .086). Freedom-from reintervention was significantly higher for primary FEVAR than secondary FEVAR, specifically 82% vs 38% at 3 years (P < .001). Primary FEVAR also had more desirable sac dynamics relative to secondary FEVAR at 3 years (primary: 54% stable, 46% regressed, 0% expanded vs secondary: 33% stable, 28% regressed, and 39% expanded; P = .038). CONCLUSIONS: FEVAR for primary aortic repair and FEVAR for rescue of prior EVAR with loss of proximal seal are two distinct entities. Following primary FEVAR, less than a quarter of patients have undergone reintervention at 3 years, and sac expansion was not seen in our cohort. Comparatively, 3 years after secondary FEVAR, over one-half of patients have undergone reintervention and over one-third have had ongoing sac expansion. Vigilant surveillance and a low threshold for further interventions are crucial following secondary FEVAR.


Subject(s)
Blood Vessel Prosthesis Implantation , Blood Vessel Prosthesis , Endovascular Procedures , Prosthesis Design , Reoperation , Humans , Endovascular Procedures/adverse effects , Endovascular Procedures/instrumentation , Endovascular Procedures/mortality , Retrospective Studies , Male , Female , Aged , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis Implantation/mortality , Time Factors , Aged, 80 and over , Risk Factors , Aortic Aneurysm, Abdominal/surgery , Aortic Aneurysm, Abdominal/mortality , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/physiopathology , Stents , Postoperative Complications/etiology , Postoperative Complications/surgery , Treatment Failure , Treatment Outcome , Endovascular Aneurysm Repair
4.
J Vasc Surg ; 79(5): 1251-1261.e4, 2024 May.
Article in English | MEDLINE | ID: mdl-37757916

ABSTRACT

OBJECTIVE: Despite open surgical repair (OSR) of abdominal aortic aneurysms being considered as a durable solution, disease progression and para-anastomotic aneurysms may require further repair, and fenestrated and branched endovascular aneurysm repair (F/BEVAR) may be applied to address these pathologies. The aim of this systematic review was to assess technical success, mortality, and morbidity (acute kidney injury, spinal cord ischemia) at 30 days, and mortality and reintervention rates during the available follow-up, in patients managed with F/BEVAR after previous OSR. METHODS: The PRISMA statement was followed, and the study was pre-registered to the PROSPERO (CRD42022363214). The English literature was searched, via Ovid, using MEDLINE, EMBASE, and CENTRAL databases, through November 30, 2022. Observational studies and case series with ≥5 patients (2000-2022), reporting on F/BEVAR outcomes after OSR, were considered eligible. The Newcastle-Ottawa Scale and GRADE were used to assess the risk of bias and quality of evidence. The primary outcome was technical success, mortality, and morbidity at 30 days. Data on the outcomes of interest were synthesized using proportional meta-analysis. RESULTS: The initial search yielded 1694 articles. Eight retrospective studies (476 patients) were considered eligible. In 78.3% of cases, disease progression set the indication for reintervention. Technical success was estimated at 96% (95% confidence interval [CI], 89%-98%; I2 = 0%; 95% prediction interval [PI], 79%-99%). Thirty-day mortality was 2% (95% CI, 1%-9%; I2 = 0%; 95% PI, 0%-28%). The estimated spinal cord ischemia and acute kidney injury rates were 3% (95% CI, 1%-9%; I2 = 0%; 95% PI, 0%-30%) and 6% (95% CI, 2%-15%; I2 = 0%; 95% PI, 1%-40%), respectively. During follow-up, overall mortality was 5% (95% CI, 2%-12%; I2 = 34%; 95% PI, 0%-45%) and aorta-related mortality was 1% (95% CI, 0%-2%; I2 = 0%; 95% PI, 0%-3%). The rate of reinterventions was 16% (95% CI, 9%-26%; I2 = 22%; 95% PI, 3%-50%). CONCLUSIONS: According to the available literature, F/BEVAR after OSR may be performed with high technical success and low mortality and morbidity during the perioperative period. Follow-up aortic-related mortality was 1%, whereas the reintervention rates were within the standard range following F/BEVAR.

5.
J Vasc Surg ; 2024 Jul 11.
Article in English | MEDLINE | ID: mdl-39002606

ABSTRACT

OBJECTIVE: Premature peripheral arterial disease (PAD) (age ≤ 50) has been shown to negatively impact the outcomes of lower extremity revascularization (LER). Patients with premature PAD have an increased risk of major amputation compared to older patients. The primary goal of this study is to compare the frequency of reinterventions after LER in patients with premature PAD to their older counterparts with common age of presentation (i.e., 60-80 years). METHODS: A retrospective review of consecutive patients undergoing LER for PAD in a single center was performed. Clinical, procedural, and socioeconomic characteristics were compared between patients with premature PAD and the older group. Perioperative as well as long-term outcomes were captured and compared including mortality, major amputation, reintervention rate and frequency, as well as major adverse limb events (MALEs). RESULTS: There were 1,274 patients who underwent LER (4.3% premature, 61.8% age 60-80). Premature PAD patients were more likely to be females of racial minorities. Notably, the mean distressed communities index (DCI) score was significantly higher in the premature PAD group compared to the older patients. Patients with premature PAD were significantly more likely to have end-stage renal disease but less likely to have hypertension, hyperlipidemia, and coronary artery disease compared to older patients. There was no significant difference in perioperative complications. After a mean follow up of 5 years, patients with premature PAD were significantly more likely to undergo more frequent reinterventions compared to older patients. Kaplan-Meier curves showed similar overall survival and MALE-free survival between the 2 groups. CONCLUSIONS: Patients with premature PAD are likely to undergo more frequent reinterventions after initial LER and have similar 5-year survival curves compared to patients at least 20 years older. Demographic and socioeconomic differences impacting patients with premature PAD, even in this relatively underpowered institutional experience, are striking and warrant further investigation.

6.
J Vasc Surg ; 79(4): 847-855.e5, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38103806

ABSTRACT

OBJECTIVE: Predictive models for reintervention may guide clinicians to optimize selection, education, and follow-up of patients undergoing endovascular iliac revascularization. Although the impact of lesion- and device-related characteristics on iliac restenosis and reintervention risk is well-defined, data on patient-specific risk factors are scarce and conflicting. This study aimed to explore the value of patient-related factors in predicting the need for clinically driven target-vessel revascularization (CD-TVR) in patients undergoing primary endovascular treatment of iliac artery disease. METHODS: Consecutively enrolled patients undergoing endovascular revascularization for symptomatic iliac artery disease at a tertiary vascular referral center between January 2008 and June 2020 were retrospectively analyzed. Primary and secondary outcomes were CD-TVR occurrence within 24 months and time to CD-TVR, respectively. Patients who died or did not require CD-TVR within 24 months were censored at the date of death or at 730 days, respectively. Multiple imputation was used to account for missing data in primary analyses. RESULTS: A total of 1538 iliac interventions were performed in 1113 patients (26% females; 68 years). CD-TVR occurred in 108 limbs (74 patients; 7.0%) with a median time to CD-TVR of 246 days. On multivariable analysis, increasing age was associated with lower likelihood of CD-TVR (odds ratio [OR], 0.64; 95% confidence interval [CI], 0.50-0.83; P = .001) and decreased risk of CD-TVR at any given time (hazard ratio [HR], 0.66; 95% CI, 0.52-0.84; P = .001). Similarly, a lower likelihood of CD-TVR (OR, 0.75; 95% CI, 0.59-0.95; P = .017) and decreased risk of CD-TVR at any given time (HR, 0.73; 95% CI, 0.58-0.93; P = .009) were observed with higher glomerular filtration rates. Lastly, revascularization of common vs external iliac artery disease was associated with lower likelihood of CD-TVR (OR, 0.48; 95% CI, 0.24-0.93; P = .030) and decreased risk of CD-TVR at any given time (HR, 0.48; 95% CI, 0.25-0.92; P = .027). No associations were observed between traditional cardiovascular risk factors (sex, hypertension, higher low-density lipoprotein cholesterol, higher hemoglobin A1c, smoking) and CD-TVR. CONCLUSIONS: In this retrospective cohort study, younger age, impaired kidney function, and external iliac artery disease were associated with CD-TVR. Traditional markers of cardiovascular risk were not seen to predict reintervention.


Subject(s)
Endovascular Procedures , Peripheral Arterial Disease , Female , Humans , Male , Iliac Artery/diagnostic imaging , Iliac Artery/surgery , Retrospective Studies , Treatment Outcome , Endovascular Procedures/adverse effects , Risk Factors , Peripheral Arterial Disease/diagnostic imaging , Peripheral Arterial Disease/therapy , Peripheral Arterial Disease/etiology
7.
Article in English | MEDLINE | ID: mdl-38924318

ABSTRACT

Minimally invasive surgery is a useful alternative to open repair for patients with nonruptured abdominal aortic aneurysms (AAA). We aim to compare the clinical outcomes for three different minimally invasive techniques: hand-assisted laparoscopic surgery (HALS), total laparoscopic surgery (TLS), and endovascular aneurysm repair (EVAR). The electronic databases MEDLINE, Embase, Web of Science, Google Scholar, and the Cochrane Library were searched between January and March 2023. Cohort studies and randomized controlled trials (RCTs) comparing two minimally invasive techniques were eligible for inclusion. Primary outcomes were mortality (in-hospital, 30-day, or 1-year) and reintervention rates (30-day or 1-year). Length of surgery, blood loss, transfusion volume, conversion to open surgery, major complication rates, length of hospital stay, and length of intensive care unit (ICU) stay were also evaluated. Eight cohort studies and one RCT were included comparing patients undergoing HALS (n = 500), TLS (n = 263), and EVAR (n = 438) for elective AAA repair. The TLS group had the highest rate of 30-day postoperative reinterventions (p = 0.00056), the longest surgical duration (p = 0.0311), and the highest rate of conversion to open surgery (p < 0.001). TLS was also associated with the most blood loss during surgery, the highest blood transfusion volumes, and the longest length of ICU stay, although these results did not reach statistical significance. Subgroup analysis revealed superior contemporary EVAR outcomes compared to TLS. Laparoscopic surgery (LAS) and EVAR have comparable mortality rates. However, LAS, particularly TLS, is significantly less efficacious than EVAR in terms of intraoperative conversions to open surgery and 30-day reintervention rates. Further controlled trials with larger sample sizes are needed to confirm the evidence.

8.
BJU Int ; 134(2): 155-165, 2024 Aug.
Article in English | MEDLINE | ID: mdl-38600763

ABSTRACT

OBJECTIVE: To assess the re-intervention rates of new surgical benign prostatic hyperplasia (BPH) interventions, as the clinical durability of new surgical interventions for BPH is not widely known. METHODS: A critical review of new surgical BPH therapies namely 'UroLift®', 'Aquablation', 'Rezum', 'prostatic artery embolisation (PAE)' and 'temporary implantable nitinol device (iTIND)' was performed on PubMed, the Cochrane Library, and Embase databases between May 2010 and December 2022 according to the Preferred Reporting Items for Systematic Review and Meta-analyses (PRISMA) statement. All relevant articles were reviewed, and the risk of bias was evaluated using the Cochrane risk assessment tool and Newcastle-Ottawa Scale. RESULTS: Of the 32 studies included, there were 10 randomised controlled trials and 22 prospective observational cohorts. A total of 2400 participants were studied with a median patient age of 66 years, a median prostate volume of 51.9 mL, and a median International Prostate Symptom Score of 22. The lowest re-intervention rate at 12 months was for Aquablation at 0.01%, followed by Rezum at 0.02%, iTIND at 0.03%, and PAE at 0.05%. Network meta-analysis (NMA) showed that the best-ranked treatment at 12 months was transurethral resection of the prostate (TURP), followed by Aquablation, iTIND, Rezum, and UroLift. Re-intervention rates with these new BPH interventions are comparable, although some interventions reported better outcomes than TURP in the shorter term. CONCLUSIONS: While this systematic review and NMA showed that the re-intervention rate with these new surgical BPH interventions appears to be comparable to TURP in the short term, further studies are required to directly compare these various BPH procedures.


Subject(s)
Network Meta-Analysis , Prostatic Hyperplasia , Reoperation , Prostatic Hyperplasia/surgery , Humans , Male , Reoperation/statistics & numerical data , Transurethral Resection of Prostate
9.
J Surg Res ; 300: 318-324, 2024 Aug.
Article in English | MEDLINE | ID: mdl-38838429

ABSTRACT

INTRODUCTION: Brachial artery trauma is a rare but potentially devastating injury. There is little data regarding risk factors for reintervention and amputation prevention in this population, as well as anticoagulant (AC) and antiplatelet (AP) regimens and outcomes after discharge in trauma patients with vascular injuries requiring repair. This study aims to identify in-hospital risk factors for reintervention and amputation and stratify outcomes of follow-up by discharge AC or AP regimen. METHODS: The AAST Prospective Observational Vascular Injury Trial database was queried for all patients who underwent traumatic brachial arterial repair from 2013 to 2022. Patients were evaluated by need for reintervention, amputation, and outcomes at follow-up by AC or AP regimen. RESULTS: Three hundred and eleven patients required brachial repair, 28 (9%) required reoperation, and 8 (2.6%) required amputation. High injury severity score and an increased number of packed red blood cells and platelets showed a significant increase for reoperation and amputation. Damage control and shunt use were significant for the need to reoperate. Seventy-four percent (221/298) of patients were discharged with postoperative AC or AP regimens. There was no significant difference of short-term follow-up by type of AC or AP regimen. CONCLUSIONS: Damage control and temporary shunt may lead to additional operations but not an increase in amputations. However, anticoagulation intraoperatively and postoperatively does not appear to play a significant role in reducing reintervention. It also suggests that there is no increase in short-term follow-up complications with or without AC or AP therapy.


Subject(s)
Amputation, Surgical , Anticoagulants , Brachial Artery , Reoperation , Vascular System Injuries , Humans , Amputation, Surgical/statistics & numerical data , Male , Female , Adult , Risk Factors , Middle Aged , Reoperation/statistics & numerical data , Brachial Artery/injuries , Brachial Artery/surgery , Anticoagulants/therapeutic use , Vascular System Injuries/surgery , Vascular System Injuries/diagnosis , Prospective Studies , Platelet Aggregation Inhibitors/therapeutic use , Young Adult , Aged , Follow-Up Studies
10.
J Endovasc Ther ; : 15266028241245911, 2024 Apr 16.
Article in English | MEDLINE | ID: mdl-38628025

ABSTRACT

PURPOSE: This systematic review aimed to summarize the effectiveness and safety of endoanchor, a stabilizing device for the proximal endograft designed to prevent endoleak and stent migration in endovascular aneurysm repair (EVAR) and thoracic endovascular aneurysm repair (TEVAR). MATERIALS AND METHODS: A systematic review and meta-analysis was conducted per the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guideline. Literature up to May 31, 2023 was searched and independently screened from 4 databases. Data were pooled for meta-analysis. Primary outcomes included intraoperative and follow-up endoleak, stent migration, and reintervention rates; sac regression; and 30-day all-cause mortality. RESULTS: Sixteen EVAR (n=1145) and 6 TEVAR studies (n=163) using the Heli-Fx EndoAnchor system were included from 2225 retrieved records. For EVAR patients (mean follow-up=11.9 months), the endoleak, graft migration, and reintervention rates were 3.97% (95% confidence interval [CI]=0.36%-1.99%), 0.004% (95% CI=0.00%-0.76%), and 5.43% (95% CI=0.86%-12.54%), respectively. The endoleak rates for primary and revision EVAR were 0.16% (95% CI=0.00%-1.65%) and 3.60% (95% CI=0.14%-9.72%), respectively. Only 4 cases of 30-day mortality (n=4) were reported in the literature. For TEVAR patients, the endoleak, stent migration, and reintervention rates were 7.4% (95% CI=0.03%-0.13%), 0.2% (95% CI=0.00%-0.06%), and 17.1% (95% CI=0.01%-0.45%), respectively. The 30-day mortality was 0.9% (95% CI=0%-0.12%). CONCLUSIONS: Endoanchor fixation in EVAR and TEVAR is effective and safe in preventing and treating endoleak and stent migration. The mortality is minimal in EVAR but higher in TEVAR. CLINICAL IMPACT: Endoleak, graft migration, and reintervention in EVAR and TEVAR with endoanchor use were rare. Mortality in EVAR was low. The adjunctive deployment of endoanchors is an effective and safe means to prevent and treat endoleak and stent migration in EVAR and TEVAR. Yet, long-term efficacy and safety data and randomized controlled trials would be required to definitively recommend endoanchor use in routine clinical practice.

11.
J Endovasc Ther ; : 15266028241232915, 2024 Feb 27.
Article in English | MEDLINE | ID: mdl-38414229

ABSTRACT

OBJECTIVE: Endovascular aneurysm repair (EVAR) has been used worldwide to treat abdominal aortic aneurysms (AAAs). Outcomes after EVAR within and outside the instruction for use (IFU) remain controversial. We analyzed long-term outcomes of EVAR within-the-IFU compared with that outside-the-IFU and baseline clinical/anatomical characteristics that influence outcomes of EVAR. METHODS: The study included 546 patients who underwent EVAR for infrarenal AAA from 1997 to 2021 at 2 Korean medical centers. The primary endpoint was graft-related adverse events (GRAEs), including type 1 or 3 endoleak, reintervention (included open conversion), aneurysm sac enlargement, aneurysm-related mortality (ARM), rupture, stent-graft migration, and stent thrombotic occlusion. RESULTS: The patients who underwent EVAR outside the IFU were 287 (52.6%). A neck angle of >60° was most common outside the IFU criteria (n=146, 50.9%). This study revealed that patients outside the IFU had a higher rate of GRAEs compared with patients within the IFU (hazard ratio [HR]: 1.879; 95% confidence interval [CI]: 1.045-2.386). A neck angle of >60° was a significant risk factor for GRAEs (adjusted HR: 2.229; 95% CI: 1.418-3.503), type 1 or 3 endoleak (adjusted HR: 2.640; 95% CI: 1.343-5.189), and reintervention (adjusted HR: 1.891; 95% CI: 1.055-3.388). CONCLUSIONS: Our study revealed EVAR with outside the IFU was associated with increased GRAEs, mainly attributed to endoleak and ARM, compared with EVAR with within the IFU. In addition, severe neck angulation was an independent risk factor for GRAEs, type 1 or 3 endoleak, and reintervention. CLINICAL IMPACT: Our study revealed endovascular aneurysm repair (EVAR) with outside-the-instruction for use (IFU) was associated with increased graft-related adverse events (GRAEs) compared with EVAR with within-the-IFU. In the low-risk population, the incidence of GRAEs and Aneurysm related mortality were higher in the outside-the-IFU group rather than within-the-IFU group. In addition, severe neck angulation was an independent risk factor for GRAEs, type 1 or 3 endoleak and reintervention.

12.
Eur J Vasc Endovasc Surg ; 67(4): 612-619, 2024 Apr.
Article in English | MEDLINE | ID: mdl-37992984

ABSTRACT

OBJECTIVE: This study aimed to investigate the correlation between aneurysm sac behaviour and time to re-intervention after endovascular aneurysm repair (EVAR). METHODS: A retrospective observational cohort study of patients who underwent EVAR at a single centre between January 2008 and November 2011 and who were followed up for a mean of 6.6 ± 2.9 years was conducted. Based on sac appearances on pre-operative imaging and imaging at the end of follow up, patients were stratified into two groups: (1) sac regression; and (2) no sac regression. The no sac regression group was further subdivided into stable sac group and sac expansion group. Sac regression and expansion throughout follow up were defined as a decrease or increase in the abdominal aortic aneurysm sac diameter of ≥ 5 mm compared with the pre-operative size. A Cox proportional hazards model using multiple failure per subject data was used to identify sac behaviour as a predictor of re-intervention free time. RESULTS: Patients with sac regression had a higher probability of freedom from re-intervention compared with those with a stable or expanding aneurysm sac (94%, 57%, and 16% at 12 years, respectively; log rank, p < .001). Mean time to re-intervention was 11.3 years for the sac regression group, 8.8 years for the stable sac group, and 5.0 years for the sac expansion group (p < .001). In the stable sac group, the risk of re-intervention increased sharply six years after EVAR, whereas in the sac expansion group a sharp rise in re-intervention was noted 3.5 years after EVAR, reaching a plateau after year 6. CONCLUSION: A time dependent correlation between aneurysm sac behaviour and re-intervention was found. Such findings have implications for surveillance strategies.


Subject(s)
Aortic Aneurysm, Abdominal , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Humans , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/surgery , Endovascular Aneurysm Repair , Treatment Outcome , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/methods , Retrospective Studies , Endovascular Procedures/adverse effects , Endovascular Procedures/methods , Risk Factors , Time Factors , Endoleak/surgery
13.
Article in Spanish | MEDLINE | ID: mdl-38874349

ABSTRACT

We describe two cases of secondary prevention subcutaneous implantable cardioverter defibrillator (S-ICD) implantation and subsequent S-ICD electrode displacement which initially went undetected. One presentation was a result of a coincidental chest x-ray for respiratory exacerbation and another with an untreated episode highlighted via remote monitoring, both patients were booked to clinic for further investigation. Our findings highlighted had there been a comparison of the existing subcutaneous electrogram (S-ECG) to captured S-ECGs at time of implant the electrode displacement would have been detected beforehand. This underpins the importance of introducing the simple management strategy into routine follow-up.

14.
Int J Hyperthermia ; 41(1): 2365388, 2024.
Article in English | MEDLINE | ID: mdl-38880505

ABSTRACT

OBJECTIVES: To investigate the long-term efficacy of ultrasound-guided high-intensity focused ultrasound (USgHIFU) for multiple uterine fibroids and the factors associated with recurrence. MATERIALS AND METHODS: Five hundred and forty-nine patients with multiple uterine fibroids treated with USgHIFU from June 2017 to June 2019 were retrospectively analyzed. The Pictorial Blood Loss Assessment Chart (PBAC) was used to assess menstrual blood loss. The patients were asked to undergo pre- and post-USgHIFU magnetic resonance imaging (MRI) and complete routine follow-up after USgHIFU. Cox regression analysis was used to investigate the risk factors associated with recurrence. RESULTS: The median number of fibroids per patient was 3 (interquartile range: 3-4), and a total of 1371 fibroids were treated. Among them, 446 patients completed 3 years follow-up. Recurrence, defined as PBAC score above or equal to 100 and/or the residual fibroid volume increased by 10%, was detected in 90 patients within 3 years after USgHIFU, with a cumulative recurrence rate of 20.2% (90/446). The multi-factor Cox analysis showed that age was a protective factor for recurrence. Younger patients have a greater chance of recurrence than older patients. Mixed hyperintensity of fibroids on T2WI and treatment intensity were risk factors for recurrence. Patients with hyperintense uterine fibroids and treated with lower treatment intensity were more likely to experience recurrence than other patients after USgHIFU. No major adverse effects occurred. CONCLUSIONS: USgHIFU can be used to treat multiple uterine fibroids safely and effectively. The age, T2WI signal intensity and treatment intensity are factors related to recurrence.


Subject(s)
High-Intensity Focused Ultrasound Ablation , Leiomyoma , Humans , Female , Leiomyoma/therapy , Leiomyoma/diagnostic imaging , Adult , Risk Factors , High-Intensity Focused Ultrasound Ablation/methods , Middle Aged , Retrospective Studies , Uterine Neoplasms/therapy , Uterine Neoplasms/diagnostic imaging , Treatment Outcome
15.
Int J Hyperthermia ; 41(1): 2384459, 2024.
Article in English | MEDLINE | ID: mdl-39074841

ABSTRACT

OBJECTIVE: This study aimed to explore the efficacy and safety of high-intensity focused ultrasound (HIFU) ablation for treating fumarate hydratase (FH)-deficient uterine leiomyomas. METHOD: Ten patients with FH-deficient uterine leiomyomas treated with HIFU ablation at the Third Xiangya Hospital from July 2017 to January 2023 were enrolled in this study. The effectiveness and adverse effects of HIFU were analyzed. RESULTS: The median age of the patients who received HIFU was 32.0 years (range: 28-41 years). Only 2 patients had solitary uterine leiomyomas, whereas the remaining 8 patients had multiple uterine leiomyomas. The median diameter of the largest myoma was 56 mm (range: 41-99 mm). Magnetic resonance imaging showed that the FH-deficient uterine leiomyomas of 8 patients presented as mixed intensity on T2WI, that of one patient was hypointense, and that of another patient was hyperintense on T2WI. All patients successfully underwent HIFU ablation in one session without severe adverse effects. The median nonperfusion volume ratio (NPVR) was 40% (30.0%-78.0%) after HIFU treatment. Four patients had NPVR ≥70%. At 3-month follow-up after HIFU ablation, the clinical symptoms of 5 of the 8 patients with symptoms before treatment were relieved. Six months after treatment, 4 of the 8 patients with symptoms were still in remission. All patients received reintervention by March 2024. The reintervention rates were 20%, 70%, and 90% at 12, 24, and 36 months, respectively, after HIFU ablation. CONCLUSION: HIFU is a safe and feasible treatment for FH-deficient uterine leiomyomas, and most patients show effective results in the short term after treatment. However, the reintervention rates are high, and the long-term effects are limited.


Subject(s)
Fumarate Hydratase , High-Intensity Focused Ultrasound Ablation , Leiomyoma , Humans , Female , High-Intensity Focused Ultrasound Ablation/methods , Adult , Leiomyoma/surgery , Leiomyoma/therapy , Fumarate Hydratase/genetics , Uterine Neoplasms/surgery , Uterine Neoplasms/therapy
16.
Int J Hyperthermia ; 41(1): 2299479, 2024.
Article in English | MEDLINE | ID: mdl-38164630

ABSTRACT

OBJECTIVES: To quantify the reintervention rate and analyze the risk factors for reintervention after high-intensity focused ultrasound (HIFU) ablation of uterine fibroids. METHODS: Eighteen studies were selected from the seven databases. A meta-analysis was applied to synthesize the reintervention rates for fibroids across various follow-up durations. Subgroup-analysis was conducted based on the year of surgery, sample size, guide methods, and non-perfusion volume ratio (NPVR). Signal intensity of T2-weighted imaging (T2WI) was independently evaluated for reintervention risk. RESULTS: The study enrolled 5216 patients with fibroids treated with HIFU. There were 3247, 1239, 1762, and 2535 women reaching reintervention rates of 1% (95% confidence interval (CI): 1-1), 7% (95% CI: 4-11), 19% (95% CI: 11-27), and 29% (95% CI: 14-44) at 12, 24, 36, and 60-month after HIFU. The reintervention rates of patients treated with US-guided HIFU (USgHIFU) were significantly lower than those of patients treated with MR-guided focused ultrasound surgery (MRgFUS). When the NPVR of fibroids was over 50%, the reintervention rates at 12, 36 and 60-month after HIFU were 1% (95% CI: 0.3-2), 5% (95% CI: 3-8), and 15% (95% CI: 9-20). The reintervention risk for hyper-intensity fibroids on T2WI was 3.45 times higher (95% CI: 2.7-4.39) for hypo-/iso-intensity fibroids. CONCLUSION: This meta-analysis showed that the overall reintervention rates after HIFU were acceptable and provided consultative suggestions regarding treatment alternatives for patients with fibroids. Subgroup-analysis revealed that USgHIFU, NPVR ≥ 50%, and hypo-/iso-intensity of fibroids on T2WI were significant factors in reducing reintervention. SYSTEMATIC REVIEW REGISTRATION: PROSPERO, CRD42023456094.


Subject(s)
High-Intensity Focused Ultrasound Ablation , Leiomyoma , Female , Humans , High-Intensity Focused Ultrasound Ablation/methods , Leiomyoma/diagnostic imaging , Leiomyoma/surgery , Magnetic Resonance Imaging/methods , Risk Factors , Treatment Outcome
17.
Int J Hyperthermia ; 41(1): 2304264, 2024.
Article in English | MEDLINE | ID: mdl-38258583

ABSTRACT

OBJECTIVE: Long-term re-intervention after ultrasound-guided high intensity focused ultrasound (USgHIFU) ablation was reported, and the prediction of non-perfusion volume ratio (NPVR) in differently aged patients with uterine fibroids (UFs) was explored. MATERIALS AND METHODS: Patients with UFs who underwent USgHIFU ablation from January 2012 to December 2019 were enrolled and divided into < 40-year-old and ≥ 40-year-old groups. Cox regression was used to analyze the influencing factors of re-intervention rate, and receiver operating characteristic (ROC) curve was used to analyze the correlation between NPVR and re-intervention rate. RESULTS: A total of 2141 patients were enrolled, and 1558 patients were successfully followed up. The 10-year cumulative re-intervention rate was 21.9%, and the < 40-year-old group had a significantly higher rate than the ≥ 40-year-old group (30.8% vs. 19.1%, p < 0.001). NPVR was an independent risk factor in both two groups. When the NPVR reached 80.5% in the < 40-year-old group and 75.5% in the ≥ 40-year-old group, the risk of long-term re-intervention was satisfactory. CONCLUSION: The long-term outcome of USgHIFU is promising. The re-intervention rate is related to NPVR in differently aged patients. Young patients need a high NPVR to reduce re-intervention risk.


Subject(s)
Leiomyoma , Humans , Aged , Adult , Perfusion , Leiomyoma/diagnostic imaging , Leiomyoma/surgery , Risk Factors
18.
BMC Womens Health ; 24(1): 294, 2024 May 18.
Article in English | MEDLINE | ID: mdl-38762488

ABSTRACT

OBJECTIVE: To report the long-term re-intervention of patients with uterine fibroids after ultrasound-guided high-intensity focused ultrasound (USgHIFU) ablation and to analyse the influencing factors of re-intervention in patients in the NPVR ≥ 80% group. MATERIALS AND METHODS: Patients with a single uterine fibroid who underwent USgHIFU at our hospital from January 2012 to December 2019 were enrolled. The patients were divided into four groups according to different nonperfusion volume ratio (NPVR). Kaplan-Meier survival curve was used to analyse long-term re-intervention in different NPVR groups, and Cox regression was used to analyse the influencing factors of re-intervention in the NPVR ≥ 80% group. MAIN RESULTS: A total of 1,257 patients were enrolled, of whom 920 were successfully followed up. The median follow-up time was 88 months, and the median NPVR was 85.0%. The cumulative re-intervention rates at 1, 3, 5, 8 and 10 years after USgHIFU were 3.4%, 11.8%, 16.8%, 22.6% and 24.1%, respectively. The 10-year cumulative re-intervention rate was 37.3% in the NPVR < 70% group, 31.0% in the NPVR 70-79% group, 18.2% in the NPVR 80-89% group and 17.8% in the NPVR ≥ 90% group (P < 0.05). However, no difference was found between the group of NPVR 80-89% and the group of NPVR ≥ 90% (P = 0.499). Age of patients and signal intensity on T2-weighted imaging (T2WI) of tumours were found to be independent risk factors for long-term re-intervention in the NPVR ≥ 80% group. A younger age and greater signal intensity on T2W images corresponded to a greater risk of re-intervention. CONCLUSION: USgHIFU, an alternative treatment for uterine fibroids, has reliable long-term efficacy. NPVR ≥ 80% can be used as a sign of technical success, which can reduce re-intervention rates. However, an important step is to communicate with patients in combination with the age of patients and the signal intensity on T2WI of fibroids. TRIAL REGISTRATION: This retrospective study was approved by the ethics committee at our institution (Registration No. HF2023001; Date: 06/04/2023). The Chinese Clinical Trial Registry provided full approval for the study protocol (Registration No. CHiCTR2300074797; Date: 16/08/2023).


Subject(s)
High-Intensity Focused Ultrasound Ablation , Leiomyoma , Uterine Neoplasms , Humans , Female , Leiomyoma/surgery , High-Intensity Focused Ultrasound Ablation/methods , Adult , Uterine Neoplasms/surgery , Middle Aged , Cohort Studies , Treatment Outcome , Retrospective Studies
19.
Ann Vasc Surg ; 2024 Jul 13.
Article in English | MEDLINE | ID: mdl-39009131

ABSTRACT

OBJECTIVE: To investigate impact of Frozen Elephant Trunk (FET) on long-term distal aortic remodelling in acute AAD according to the latest recommended standards from the Society for Vascular Surgery (SVS)/Society of Thoracic Surgeons (STS). METHODS: Clinical data and imaging of patients undergone FET to treat acute AAD over the last 8 years were retrospectively reviewed. Patients were included if a pre- and post-operative Computed AngioTomographies at least 30-day from surgery was available for comparison. Contrasted postprocessed imaging were analysed with Aquarius iNtuition (TeraRecon Inc., Foster City, CA, USA) to analyse long-term positive aortic remodelling, FL thrombosis and aortic expansion according to the SVS/STS recommendations. Secondary endpoints were the rate of in-hospital and long-term mortality, spinal cord ischaemia and aortic-related reinterventions. RESULTS: Out of 75 patients who underwent FET for type A AAD, n=41(54.6%) were included. Significant positive aortic remodelling was reported in Ishimaru zone 1-4 but not in visceral/infrarenal aorta (p<0.001) and overall rate of FL thrombosis was 95.1% (n=39). Aortic expansion rates were: 4.9% in zones 1-4, 8.3% in zones 5-6 and 15% in zone 7. The rates of in-hospital mortality and long-term mortality were 7.3% (n=3) and 9.7% (n=4) respectively. At a median follow-up of 11 months (range 1-141, reintervention rate was 17.1%. CONCLUSIONS: We report positive aortic remodelling of the distal thoracic aorta in patients who underwent FET for acute AAD according to the SVS/STS reporting standards. The positive effect on the distal aorta is limited to the thoracic segments but not in the visceral aorta.

20.
Ann Vasc Surg ; 2024 Jul 12.
Article in English | MEDLINE | ID: mdl-39004278

ABSTRACT

INTRODUCTION: Blunt thoracic aortic injury (BTAI) represents one of the most devastating scenarios of vascular trauma. Different management strategies are available with varying clinical outcomes. However, thoracic endovascular aortic repair (TEVAR) has become the first-line option for most BTAI patients, mainly owing to its minimally invasive nature, yielding improved immediate results. This meta-analysis aims to investigate mortality, long-term survival, and reintervention following TEVAR in BTAI. MATERIAL AND METHODS: A systematic review conducted a comprehensive literature search on multiple electronic databases using strict search terms. Twenty-seven studies met the set inclusion/exclusion criteria. A proportional meta-analysis of extracted data was conducted using the Comprehensive Meta-Analysis Software v.4. RESULTS: 1498 BTAI patients who underwent TEVAR were included. Using the SVS grading system, 2.6% of the population had Grade 1 injuries, 13.6% Grade 2, 62.2% Grade, 19.6% Grade 4, and 1.9% unspecific. All-cause mortality did not exceed 20% in all studies except one outlier with a 37% mortality rate. Using the random-effects model, the pooled estimate of overall mortality was 12% (95%CI 5.35-8.55%; I2 = 70.6%). This was 91% (95%CI, 88.6-93.2; I2 = 30.2%) at 6 months, 90.1% (95%CI, 86.7-92.3; I2 = 53.6%) at 1-year, 89.2% (95%CI, 85.2-91.8; I2= 62.3%) at 2 years, and 88.1% (95%CI, 83.3-90.9; I2 = 69.6%) at 5 years. Moreover, the pooled estimate of reintervention was 6.4% (95%CI, 0.1-0.49%; I2 = 81.7%). CONCLUSION: Despite the high morbidity and mortality associated with BTAI, TEVAR has proven to be a safe and effective management strategy with favourable long-term survival and minimal need for reintervention. Nevertheless, diagnosis of BTAI requires a high index of suspicion with appropriate grading and prompt transfer to trauma centres with appropriate TEVAR facilities.

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