Effect of a closure device on complication rates in high-local-risk patients: Results of a randomized multicenter trial

Purpose: To evaluate the safety and effectiveness of the MANTA percutaneous vascular closure device in patients undergoing percutaneous endovascular aneurysm repair (PEVAR) or thoracic endovascular aortic repair (TEVAR). Materials and Methods: The SAFE MANTA Study ( ClinicalTrials.gov identifier NCT02908880) was a prospective, single-arm, multicenter trial in patients undergoing endovascular interventions using large-bore sheaths (transcatheter aortic valve replacement, PEVAR, or TEVAR) at 20 sites in North America. Patient selection intended to test the MANTA device in populations without morbid obesity, severe calcification, or a severely scarred femoral access area. Of the 263 patients enrolled in the primary analysis cohort, 53 (20.2%) patients (mean age 74.9±8.9 years; 41 men) underwent PEVAR (n=51) or TEVAR (n=2) procedures and form the cohort for this subgroup analysis. Per protocol a single MANTA device was deployed in all PEVAR/TEVAR cases. Results: The mean time to hemostasis in the PEVAR/TEVAR cohort was 35±91 seconds, with a median time of 19 seconds vs 24 seconds in the overall SAFE MANTA population. The MANTA device met the definition for technical success in 52 (98%) of 53 PEVAR/TEVAR cases compared with 97.7% in the overall SAFE MANTA population. One (1.9%) major complication (access-site stenosis) occurred in this subgroup compared to 14 (5.3%) events in the SAFE population. In the PEVAR/TEVAR group, 1 pseudoaneurysm was noted prior to discharge, another at 30-day follow-up, and one at 60 days. One (1.9%) of the 3 minor pseudoaneurysms was treated with ultrasound-guided compression and the other 2 required no treatment. Conclusion: The MANTA device demonstrated a short time to hemostasis and low complication rates compared with published literature results of other percutaneous closure devices. Time to hemostasis and complication rates were comparable between the PEVAR/TEVAR patients and the full SAFE MANTA study cohort. The MANTA device provides reliable closure with a single percutaneous device for PEVAR/TEVAR procedures.

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Aggressive intravenous hydration with lactated Ringer’s solution for prevention of post-ERCP pancreatitis: a prospective randomized multicenter clinical trial

Endoscopy ◽

10.1055/s-0043-122386 ◽

2017 ◽

Vol 50 (04) ◽

pp. 378-385 ◽

Cited By ~ 11

Author(s):

Chang-Hwan Park ◽

Woo Paik ◽

Eun Park ◽

Chan Shim ◽

Tae Lee ◽

...

Keyword(s):

High Risk ◽

Multicenter Trial ◽

High Risk Patients ◽

Intention To Treat ◽

Ringer’S Solution ◽

Significant Difference ◽

Risk Patients ◽

Intravenous Hydration ◽

Lactated Ringer's Solution ◽

First Time

Abstract Background and study aims The present study aimed to determine the type of intravenous hydration that is best suited to reducing the incidence of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis. Patients and methods In a prospective randomized multicenter trial, average-to-high risk patients who underwent first-time ERCP were randomly assigned to three groups (1:1:1) who received: aggressive intravenous hydration (3 mL/kg/h during ERCP, a 20-mL/kg bolus and 3 mL/kg/h for 8 hours after ERCP) with either lactated Ringer’s solution (LRS) or normal saline solution (NSS), or standard intravenous hydration with LRS (1.5 mL/kg/h during and for 8 hours after ERCP). The primary end point was post-ERCP pancreatitis (PEP). Results 395 patients were enrolled, and 385 completed the protocols. The three groups showed no significant differences in demographic characteristics. There was a significant difference in the intention-to-treat (ITT) PEP rate between the aggressive LRS group (3.0 %, 95 % confidence interval [CI] 0.1 % – 5.9 %; 4 /132), the aggressive NSS group (6.7 %, 95 %CI 2.5 % – 10.9 %; 9 /134) and the standard LRS group (11.6 %, 95 %CI 6.1 % – 17.2 %; 15 /129; P = 0.03). In the two-group comparisons, the ITT PEP rate was significantly lower for the aggressive LRS group than for the standard LRS group (relative risk [RR] 0.26, 95 %CI 0.08 – 0.76; P = 0.008). There was no significant difference in the ITT PEP rate between the aggressive NSS group and the standard LRS group (RR 0.57, 95 %CI 0.26 – 1.27; P = 0.17). Conclusion Aggressive hydration with LRS is the best approach to intravenous hydration for the prevention of PEP in average-to-high risk patients.

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Usefulness of a Nonsuture Closure Device in Patients Undergoing Diagnostic Coronary and Peripheral Angiography

International Journal of Angiology ◽

10.1055/s-0037-1607037 ◽

2017 ◽

Vol 26 (04) ◽

pp. 228-233

Author(s):

John Owens ◽

Shaun Bhatty ◽

Robert Donovan ◽

Andrea Tordini ◽

Peter Danyi ◽

...

Keyword(s):

Closure Device ◽

Complication Rates ◽

Manual Compression ◽

Access Site ◽

Femoral Access ◽

Peripheral Angiography ◽

Major Complications ◽

Increased Risk ◽

Male Patients ◽

To Receive

AbstractVascular access site complications can follow diagnostic coronary and peripheral angiography. We compared the complication rates of the Catalyst vascular closure device, with the complication rates after manual compression in patients undergoing diagnostic angiographic procedures via femoral access. We studied 1,470 predominantly male patients undergoing diagnostic coronary and peripheral angiography. Catalyst closure devices were used in 436 (29.7%) patients and manual compression was used in 1,034 (70.3%) patients. The former were allowed to ambulate after 2 hours, while the latter were allowed to ambulate after 6 hours. Major complications occurred in 4 (0.9%) patients who had a Catalyst device and in 14 (1.4%) patients who had manual compression (odds ratio [OR]: 0.67, 95% confidence interval [CI]: 0.22–2.1, p = 0.49). Any complications occurred in 51 (11.7%) patients who had a Catalyst closure device and in 64 (6.2%) patients who had manual compression (OR: 2, CI: 1.4–3, p < 0.01). After adjustment for other variables and for a propensity score reflecting the probability to receive the closure device, the association of major complications with the use of the closure device remained not significant (OR: 0.54, 95% CI: 0.17–1.7, p = 0.29), while the association of any complications with the use of the Catalyst device remained significant (OR: 1.9, 95% CI: 1.3–2.9, p < 0.01). The Catalyst device was not associated with an increased risk of major groin complications but was associated with an increased risk of any complications compared with manual compression. Patients receiving the closure device ambulated sooner.

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Chemotherapy in 998 unselected childhood acute lymphoblastic leukemia patients. Results and conclusions of the multicenter trial ALL-BFM 86

Blood ◽

10.1182/blood.v84.9.3122.3122 ◽

1994 ◽

Vol 84 (9) ◽

pp. 3122-3133 ◽

Cited By ~ 414

Author(s):

A Reiter ◽

M Schrappe ◽

WD Ludwig ◽

W Hiddemann ◽

S Sauter ◽

...

Keyword(s):

Acute Lymphoblastic Leukemia ◽

Risk Group ◽

Lymphoblastic Leukemia ◽

Multicenter Trial ◽

Low Risk ◽

Event Free Survival ◽

Free Survival ◽

Risk Patients ◽

To Receive

Abstract In trial ALL-BFM 86, the largest multicenter trial of the Berlin- Frankfurt-Munster (BFM) study group for childhood acute lymphoblastic leukemia (ALL), treatment response was used as an overriding stratification factor for the first time. In the previous trial ALL-BFM 83, the in vivo response to initial prednisone treatment was evaluated prospectively. A blast cell count of > or = 1,000/microL peripheral blood after a 7-day exposure to prednisone and one intrathecal dose of methotrexate (MTX) identified 10% of the patients as having a significantly worse prognosis. In trial ALL-BFM 86 patients with > or = 1,000/microL blood blasts on day 8 were included in an experimental branch EG. Patients with < 1,000/microL blood blasts on day 8 were stratified by their leukemic cell burden into two branches, Standard Risk Group (SRG) and Risk Group (RG). SRG patients received an eight- drug induction followed by consolidation protocol M (6-mercaptopurine, high-dose [HD] MTX 4 x 5 g/m2) and maintenance. RG patients were treated with an additional eight-drug reinduction element. For EG patients protocol M was replaced by protocol E (prednisone, HD-MTX, HD- cytarabine, ifosfamide, mitoxantrone). All patients received intrathecal MTX therapy; only those of branches RG and EG received cranial irradiation. In branch RG, patients were randomized to receive or not to receive late intensification (prednisone, vindesine, teniposide, ifosfamide, HD-cytarabine) in the 13th month. During the trial reinduction therapy was introduced in branch SRG, because in the follow-up of trial ALL-BFM 83 the randomized low-risk patients receiving reinduction did significantly better. Nine hundred ninety- eight evaluable patients were enrolled, 28.6% in SRG, 61.1% in RG, 10.3% in EG. At a median follow-up of 5.0 (range 3.4 to 6.9) years, the estimated 6-year event-free survival was 72% +/- 2% for the study population, 58% +/- 5% in branch SRG for the first 110 patients without reinduction therapy, 87% +/- 3% for the next 175 patients with reinduction therapy, 75% +/- 2% in branch RG, and 48% +/- 5% in branch EG. Late intensification did not significantly affect treatment outcome of RG patients; however, only 23% of the eligible patients were randomized. Prednisone poor response remained a negative prognostic parameter despite intensified therapy. The results confirmed the benefit of intensive reinduction therapy even for low-risk patients. The strategy of induction, consolidation, and intensive reinduction may offer roughly 75% of unselected childhood ALL patients the chance for an event-free survival.

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The use of the Angio-Seal haemostatic puncture closure device in high risk patients

Clinical Radiology ◽

10.1016/s0009-9260(99)91240-0 ◽

1999 ◽

Vol 54 (1) ◽

pp. 51-55 ◽

Cited By ~ 29

Author(s):

G.J. O'Sullivan ◽

T.M. Buckenham ◽

A.M. Belli

Keyword(s):

High Risk ◽

Closure Device ◽

High Risk Patients ◽

Risk Patients

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Screening of Nutritional Risk and Nutritional Support in General Surgery Patients: A Survey from Shanghai, China

International Surgery ◽

10.9738/intsurg-d-14-00245.1 ◽

2015 ◽

Vol 100 (5) ◽

pp. 841-848 ◽

Cited By ~ 4

Author(s):

Zhen-Yi Jia ◽

Jun Yang ◽

Da-Nian Tong ◽

Jia-Yuan Peng ◽

Zhong-Wei Zhang ◽

...

Keyword(s):

Gastric Cancer ◽

At Risk ◽

Clinical Outcomes ◽

Support Group ◽

Complication Rate ◽

Nutritional Support ◽

Nutritional Risk ◽

Complication Rates ◽

Lower Complication ◽

Risk Patients

To determine the prevalence of nutritional risk in surgical departments and to evaluate the impact of nutritional support on clinical outcomes. The nutritional risk in different surgical diseases and the different way of nutritional support on clinical outcomes in patients at nutritional risk remain unclear. Hospitalized patients from general surgical departments were screened using the Nutritional Risk Screening (NRS) 2002 questionnaire on admission. Data were collected on nutritional risk, complications, and length of stay (LOS). Overall, 5034 patients were recruited; the overall prevalence of nutritional risk on admission were 19.2%. The highest prevalence was found among patients with gastric cancer. At-risk patients had more complications and longer LOS than nonrisk patients. Of the at-risk patients, the complication rate was significantly lower and LOS was significantly shorter in the nutritional-support group than in the no-support group (20.9 versus 30.0%, P < 0.05). Subgroup analysis showed reduced complication rates and LOS only in patients with gastric cancer, colorectal cancer, and hepato-pancreato-biliary (HPB) cancer. Significantly lower complication rates relative to nonsupported patients were found among patients who received enteral nutrition or who received support for 5 to 7 days, or daily support entailing 16 to 25 kcal/kg of nonprotein energy. Different surgical diseases have different levels of nutritional risk. The provision of nutritional support was associated with a lower complication rate and a shorter LOS for gastric, colorectal, and HPB cancer patients at nutritional risk. The improper use of nutritional support may not improve outcomes for at-risk patients.

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Outcome of left atrial appendage occlusion in high-risk patients

Heart ◽

10.1136/heartjnl-2017-312383 ◽

2017 ◽

Vol 104 (7) ◽

pp. 594-599 ◽

Cited By ~ 7

Author(s):

Ahmed Masoud ◽

Stefano Bartoletti ◽

Timothy Fairbairn ◽

Ayush Khurana ◽

Periaswamy Velavan ◽

...

Keyword(s):

Atrial Fibrillation ◽

Adverse Events ◽

Stroke Prevention ◽

Left Atrial ◽

Left Atrial Appendage ◽

Atrial Appendage ◽

Complication Rates ◽

Serious Adverse Events ◽

Risk Patients

ObjectivePercutaneous left atrial appendage (LAA) occlusion can be an interventional alternative to oral anticoagulation for stroke prevention in patients with atrial fibrillation.MethodsWe delivered LAA occlusion therapy using a standardised approach to patient referral, multidisciplinary team assessment, implant criteria, imaging and follow-up. We analysed patient characteristics, efficacy and safety of the implant procedure, and 12-month outcomes.ResultsOf 143 referrals from October 2014 to December 2016, 83 patients (age 76±8years, 32.5% female, mean CHAD2S2-VASc score 4 ±1) were offered LAA occlusion. Eighty (95.3%) had previous major bleeding (intracranial in 59%). LAA occluder implantation with an Amulet device was successful in 82 (98.8%), with periprocedural major adverse events occurring in 5 (6.0%) patients (2 device embolisations including 1 death, 2 major bleeds). Cardiac imaging in 75 (94%) patients 2months following implant showed device-related thrombus in 1 case (1.3%) and minor (<5mm) device leaks in 13 (17.1%). Over a median 12-month follow-up, 3 (3.8%) ischaemic strokes, 2 (2.5%) haemorrhagic strokes and 5 (6.3%) major extracranial bleeds occurred. All-cause mortality was 10%, with most deaths (7, 87.5%) due to non-cardiovascular causes.ConclusionsLAA occlusion may be a reasonable option for stroke prevention inhigh-risk patients with atrial fibrillation ineligible for anticoagulation. However, procedural complication rates are not insignificant, and patients remain at risk of serious adverse events and death even after successful implant.

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Safety and Efficacy of Arterial Closure Devices Following Antegrade Femoral Access: A Case–Control Study

Vascular and Endovascular Surgery ◽

10.1177/1538574420941298 ◽

2020 ◽

Vol 54 (7) ◽

pp. 612-617

Author(s):

Louis-Xavier Barrette ◽

Ansar Z. Vance ◽

Mark P. Mantell ◽

Kathleen M. Kratz ◽

Jonas W. Redmond ◽

...

Keyword(s):

Control Group ◽

Closure Device ◽

Consecutive Series ◽

Complication Rates ◽

Success Rates ◽

Femoral Access ◽

Safety And Efficacy ◽

Antegrade Approach ◽

Device Deployment ◽

Percutaneous Revascularization

Purpose: Vascular closure device (VCD) use following antegrade femoral access may present unique challenges relative to retrograde access. We retrospectively compared safety and efficacy of these devices between antegrade and retrograde patient cohorts undergoing percutaneous intervention. Materials and Methods: Over a 5-year period, a consecutive series of 107 limbs in 84 patients underwent VCD arteriotomy closure following percutaneous revascularization using an antegrade approach (VCD-A). Device deployment success rates, time to ambulation, and complication rates were compared to a contemporaneous control group of 401 limbs in 305 patients who underwent closure following retrograde access (VCD-R) during revascularization or embolization procedures. Results: Closure was attempted in VCD-A using 53 StarClose, 35 Perclose, and 19 Angio-Seal devices. Hemostasis (without supplemental manual compression) was achieved in 86/107 (80.4%) limbs. Closure was attempted in VCD-R using 215 StarClose, 119 Perclose, and 67 Angio-Seal devices with hemostasis in 357/401 (89.0%) limbs. Device deployment failure occurred in 7/107 (6.5%) of VCD-A and 20/401 (5.0%) of VCD-R ( P = .52), independent of specific device type. Femoral pseudoaneurysm developed in 1/107 and 1/401 of VCD-A and VCD-R ( P = .31), and minor hematoma developed in 3/107 and 8/401 of the VCD-A and VCD-R ( P = .61). Mean time to ambulation was 204.1 minutes in VCD-A and 204.8 minutes in VCD-R ( P = .97). Conclusion: Antegrade femoral closure was associated with high rates of technical success and low complications, similar to retrograde closure. Time to ambulation was the same in both groups despite higher heparin doses in the antegrade patients.

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Evaluation of the MANTA Vascular Closure Device in Transfemoral TAVI

The Thoracic and Cardiovascular Surgeon ◽

10.1055/s-0041-1730972 ◽

2021 ◽

Author(s):

Lukasz Kmiec ◽

Matthaeus Zerdzitzki ◽

Christof Schmid ◽

Kurt Debl ◽

Samuel Sossalla ◽

...

Keyword(s):

Academic Research ◽

Case Series ◽

Vascular Complications ◽

Female Gender ◽

Closure Device ◽

Complication Rates ◽

Imaging Data ◽

Patient Death ◽

Vascular Closure Device ◽

Puncture Site

Abstract Background The MANTA vascular closure device (VCD) is a novel collagen plug-based VCD for large bore arteriotomies. The current literature regarding complication rates of this device is quite variable and mostly limited to relatively small case series. Methods This study is retrospective analysis of the MANTA VCD-related main access site complications according to Valve Academic Research Consortium-2 (VARC-2) criteria during the hospital stay. Particular attention was paid to the detailed analysis of multislice computed tomography with regard to the anatomy of the access vessel and the puncture site itself. Results A total of 524 patients underwent transfemoral transcatheter aortic valve implantation (TF TAVI) including the use of the MANTA device (18F) for percutaneous vascular closure. A group of 22 patients was excluded from the study due to incomplete imaging data. During the study period, we observed 28 major (5.6%) and five minor (1.0%) MANTA device-related vascular complications. There was no patient death related to these adverse events. Female gender, vessel angulation at the puncture site, and at least moderate calcification of the dorsal vessel segment were identified as independent predictors for major complications. Conclusions The MANTA device is a feasible option for vascular closure of large bore arteriotomies in patients undergoing TF TAVI or other percutaneous transfemoral interventions. Furthermore, we have identified novel predictors for device failure/complications that should be taken into account for selection of the appropriate closure device. To our knowledge, this report is one of the largest case series analyzing the use of the MANTA VCD.

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Good Response to Decitabine in an Elderly Patient with MDS (Refractory Anemia with Excess Blasts RAEB-2) after Failure of Azacitidine.

Blood ◽

10.1182/blood.v110.11.4597.4597 ◽

2007 ◽

Vol 110 (11) ◽

pp. 4597-4597

Author(s):

Ashraf R. Aziz

Keyword(s):

High Risk ◽

Objective Response ◽

Risk Groups ◽

Iron Chelator ◽

Multicenter Trial ◽

Refractory Anemia ◽

High Risk Patients ◽

Normal Limits ◽

Number Of Patients ◽

Risk Patients

Decitabine, A pyrimidine nucleoside analog of cytidine, 5-aza-2′-deoxycytidine strongly inhibits DNA methylation, is capable of inducing cell differentiation, In a phase II multicenter trial of 66 patients with MDS (median age 68 years, range: 38 to 84), DAC was given in a dose of 15 mg/m2 IV over 4 hours every eight hours for three consecutive days; cycles were repeated every six weeks. The overall response rate was 25, 48, and 64 percent for those in the intermediate-I, intermediate-II, and high IPSS risk groups, respectively. The median survival time from the start of treatment for the IPSS high risk patients was 1.2 years, considerably longer than the expected survival of 0.3 to 0.5 years for high risk patients treated with supportive care alone. Response to Decitabine after failure of Azaitadine was mentioned only in one abstract presented in the American society of hematology meeting 2006 in 22 patients. We present a case of an 83 y/o gentleman with RAEB-2 with IPSS of 1 Intermediate I with normal cytogenetics, trilineage pancytopenia, was heavily transfusion dependent with both red cells and platelets on a weekly bases. The patient was treated initially with Revlamide for 3 months, followed by Azacitadine for total of 4 cycles, along with Exjade as an iron chelator without any objective response or reduction in his transfusion requirement. The patient eventually was switched to Decitabine 20 mg SC daily for 5 days every 28 days. The patient started to have a response after the 4 th cycle with prolongation of his transfusion intervals. After the 5 th cycle the patient did not need transfusions with platelets within normal limits. Since there is paucity of data regarding the response to these new agents, our case may be added to the small number of patients that was presented to try to create a data pool that helps clinicians to manage this difficult disease.

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