976-P: Post Market Clinical Follow-Up (PMCF) Registry to Demonstrate the Long Term Safety of the Eversense CGM System

Background As a new endovascular reconstruction technique, flow diverter (FD) shows excellent efficacy and safety for treatment of intracranial aneurysms. In a previous multicenter, randomized, controlled, pre-market study, Tubridge FD showed remarkably higher complete occlusion rate compared with traditional stent-assisted coiling. However, a nonsignificant higher complication rate in the Tubridge group was noted. Considering the learning curve, the safety, and long-term outcomes of Tubridge FD should be verified in new prospective, real world, multicenter, post-market trials. Methods This study is a prospective, multicenter, single-arm, post-market clinical trial that evaluates the safety and efficacy of Tubridge in the treatment of patients with intracranial aneurysms by reconstructing parent artery. We expect 200 participants who meet the inclusion and exclusion criteria to be included. Clinical information and angiographic results (Raymond–Roy grading scale, RRGS) will be recorded objectively. The primary endpoint will be the complete occlusion rate of the target aneurysm (RRGS 1) at 12-month follow-up. Secondary endpoints will include the adequate occlusion rate (RRGS 1 & 2) and the rate of major in-stent stenosis (>50%) at 12-month follow-up, technique success rate, changes of modified Rankin Scale before and after the procedure, the rate of aneurysm related disability, neurological mortality, and all-cause mortality within follow-up period. Discussion This post-market, prospective trial may offer more information on the safety and long-term outcomes of Tubridge FD. When the study is complete, the results may provide us a new strategy for the treatment of intracranial aneurysms. Trial registration: WHO-Chinese Clinical Trial Registry: ChiCTR2000032282.

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Paclitaxel-coated Zilver PTX drug-eluting stent treatment does not result in increased long-term all-cause mortality compared to uncoated devices from Japan post-market surveillance study

European Heart Journal ◽

10.1093/ehjci/ehaa946.2379 ◽

2020 ◽

Vol 41 (Supplement_2) ◽

Author(s):

H Yokoi

Keyword(s):

Real World ◽

Drug Eluting Stent ◽

Long Term Outcomes ◽

Risk Of Mortality ◽

All Cause Mortality ◽

Post Market ◽

Drug Eluting ◽

Zilver Ptx

Abstract Purpose Favorable long-term outcomes with the Zilver PTX drug-eluting stent (DES) in treating patients with femoropopliteal lesions have been demonstrated. A multicenter, prospective, post-market surveillance study (PMS) in Japan evaluated this DES in a real-world patient population. Recently, meta-analysis that grouped both DES and drug-coated balloons (DCB) together indicated a higher incidence of late all-cause mortality for paclitaxel- based devices compared to uncoated balloon or bare-metal stent (BMS) at 2 years up to 5 years. To evaluate the long-term safety of the Zilver PTX DES, compared with BMS using Japan-PMS study. Methods The Japan DES PMS had no exclusion criteria and enrolled consecutive patients with symptomatic PAD involving the above-the-knee femoropopliteal arteries. Safety and effectiveness of the DES was evaluated in real-world patients with complex femoropopliteal artery lesions through 5 years. Follow-up in the study is complete. The concurrent Japan BMS PMS also had no exclusion criteria and enrolled consecutive patients with symptomatic PAD involving the above-the-knee femoropopliteal arteries. Patients who were enrolled in the BMS study but who also had a DES placed (n=18) were excluded from the current analysis. Follow-up in the BMS study was only required through 3 years and is complete. Results The Japan DES PMS enrolled 904 DES patients, and the Japan BMS PMS enrolled 190 BMS patients. In the DES group, there were 127 deaths through 3 years and 186deaths through 5 years. In the BMS group, there were 22 deaths through 3 years. Through 3 years, the risk of mortality was 15.7% for DES group and 15.3% for BMS group. Through 5 years, the risk of mortality was 25.8% for the DES group. There was no difference in mortality between the two groups (log-rank p=0.92).The Cox proportional hazards model revealed that CLI (p<0.0001), age (p<0.0001), gender (p=0.001), renal failure (p<0.0001) were significantly associated with mortality. Hypercholesterolemia (p=0.004) was associated with lower risk of mortality. Treatment with Zilver PTX (p=0.49) was not associated with mortality. In the covariate analysis of paclitaxel dose, the significant factors were identical to the treatment analysis, and there was no association or trend of paclitaxel dose (p=0.07) with mortality. Conclusion Analyses of the paclitaxel-coated Zilver PTX DES utilizing patient-level data from the Japan PMS demonstrated no increase in long-term all-cause mortality. The 5-year results from this real-world, all-comers study continue to show positive long-term outcomes and demonstrate the benefit of the Zilver PTX DES across a broad patient population. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): COOK

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Long-term follow-up of the German post-market study for upper airway stimulation for obstructive sleep apnea

Sleep And Breathing ◽

10.1007/s11325-019-01933-0 ◽

2019 ◽

Vol 24 (3) ◽

pp. 979-984 ◽

Cited By ~ 3

Author(s):

Armin Steffen ◽

Ulrich J. Sommer ◽

Joachim T. Maurer ◽

Nils Abrams ◽

Benedikt Hofauer ◽

...

Keyword(s):

Obstructive Sleep Apnea ◽

Sleep Apnea ◽

Upper Airway ◽

Upper Airway Stimulation ◽

Obstructive Sleep ◽

Post Market ◽

Long Term Follow Up

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Dyshidrotic eczema in two patients on secukinumab for plaque psoriasis: A case report

SAGE Open Medical Case Reports ◽

10.1177/2050313x20904561 ◽

2020 ◽

Vol 8 ◽

pp. 2050313X2090456 ◽

Cited By ~ 1

Author(s):

Reetesh Bose ◽

Jennifer Beecker

Keyword(s):

Rare Variants ◽

Necrosis Factor Alpha ◽

Post Market Surveillance ◽

Interleukin 17A ◽

Potential Association ◽

Post Market ◽

Factor Alpha ◽

Necrosis Factor

Secukinumab was the first fully human anti-interleukin-17a monoclonal antibody and successfully treated moderate-severe psoriasis. These new, targeted, medications are becoming more ubiquitous, but long-term side effects are not fully known. Post-market surveillance is crucial to identify delayed adverse events, analogous to the paradoxical development of pustular psoriasis in a subset of patients treated with the anti-tumor necrosis factor-alpha class drugs. Dyshidrotic eczema and pompholyx are rare variants of dermatitis characterized by vesicles or bullae on the palms, soles and sides of the fingers. The etiology of dyshidrotic eczema is not always known, but medications have been implicated in a minority of patients. Herein, we present two cases of dyshidrotic eczema developing in patients on secukinumab for psoriasis. Extended follow-up and larger numbers of patients are needed to fully understand the potential association between secukinumab and dyshidrotic eczema.

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Paclitaxel-Coated Zilver PTX Drug-Eluting Stent Treatment Does Not Result in Increased Long-Term All-Cause Mortality Compared to Uncoated Devices

CardioVascular and Interventional Radiology ◽

10.1007/s00270-019-02324-4 ◽

2019 ◽

Vol 43 (1) ◽

pp. 8-19 ◽

Cited By ~ 11

Author(s):

Michael D. Dake ◽

Gary M. Ansel ◽

Marc Bosiers ◽

Andrew Holden ◽

Osamu Iida ◽

...

Keyword(s):

Controlled Trial ◽

Drug Eluting Stent ◽

Randomized Controlled ◽

Level Data ◽

All Cause Mortality ◽

Post Market ◽

Drug Eluting ◽

Zilver Ptx

Abstract Purpose Patient-level data from two large studies of the Zilver PTX drug-eluting stent (DES) with long-term follow-up and concurrent non-drug comparator groups were analyzed to determine whether there was an increased mortality risk due to paclitaxel. Methods Data from the Zilver PTX randomized controlled trial (RCT) and Zilver PTX and bare metal stent (BMS) Japan post-market surveillance studies were analyzed. Five-year follow-up is complete in both DES studies; follow-up for the BMS study was limited to 3 years and is complete. Kaplan–Meier analyses assessed mortality. A Cox proportional hazards model identified significant factors related to mortality. Results In the RCT, there were 336 patients treated with the DES and 143 patients treated with percutaneous transluminal angioplasty (PTA) or BMS. In Japan, there were 904 DES patients and 190 BMS patients. There was no difference in all-cause mortality for the DES compared to PTA/BMS in the RCT (19.1% DES versus 17.1% PTA/BMS through 5 years, p = 0.60) or Japan (15.8% DES versus 15.3% BMS through 3 years, p = 0.89). Cox proportional hazard models revealed that age, tissue loss, and congestive heart failure were significantly associated with mortality in the RCT, and critical limb ischemia, age, renal failure, and gender were significantly associated with mortality in Japan (all p < 0.05). Neither treatment with Zilver PTX (p = 0.46 RCT, p = 0.49 Japan) nor paclitaxel dose (p = 0.86 RCT, p = 0.07 Japan) was associated with mortality. Conclusion Analyses of the Zilver PTX patient-level data demonstrated no increase in long-term all-cause mortality. Level of Evidence Zilver PTX RCT: Level 1, randomized controlled trial; Japan PMS studies: Level 3, post-market surveillance study.

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The LUNA aneurysm embolization system for intracranial aneurysm treatment: short-term, mid-term and long-term clinical and angiographic results

Journal of NeuroInterventional Surgery ◽

10.1136/neurintsurg-2018-013767 ◽

2018 ◽

Vol 10 (12) ◽

pp. e34-e34 ◽

Cited By ~ 8

Author(s):

Michel Piotin ◽

Alessandra Biondi ◽

Nader Sourour ◽

Charbel Mounayer ◽

Maciej Jaworski ◽

...

Keyword(s):

Intracranial Aneurysms ◽

Minor Stroke ◽

Clinical Trial Registration ◽

Neck Size ◽

Aneurysm Embolization ◽

Post Market ◽

Endovascular Approach ◽

Aneurysm Occlusion

Background and purposeIntrasaccular aneurysm flow disruption represents an emerging endovascular approach to treat intracranial aneurysms. The purpose of this study was to determine the clinical and angiographic outcomes of using the LUNA aneurysm embolization system (AES) for treatment of intracranial aneurysms.Materials and methodsThe LUNA AES Post-Market Clinical Follow-Up study is a prospective, multicenter, single-arm study that was designed to evaluate device safety and efficacy. Bifurcation and sidewall aneurysms were included. Aneurysm occlusion was assessed using the Raymond-Roy classification scale. Disability was assessed using the Modified Rankin Scale (mRS). Morbidity was defined as mRS >2 if baseline mRS ≤2, increase in mRS of 1 or more if baseline mRS >2, or mRS >2 if aneurysm was ruptured at baseline. Clinical and angiographic follow-up was conducted at 6, 12 and 36 months.ResultsSixty-three subjects with 64 aneurysms were enrolled. Most aneurysms were unruptured (60/63 (95.2%)); 49 were bifurcation or terminal (49/64 (76.6%)). Mean aneurysm size was 5.6±1.8 mm (range, 3.6–14.9 mm), and mean neck size was 3.8±1.0 mm (range, 1.9–8.7 mm). Though immediate postoperative adequate occlusion was low (11/63, 18%), adequate occlusion was achieved in 78.0% (46/59) and 79.2% (42/53) of the aneurysms at 12 months and 36 months, respectively. Four patients were retreated by the 12-month follow-up (4/63 (6.3%)) and three patients were retreated by the 36-month follow-up (3/63 (4.8%)). There were two major strokes (2/63 (3.2%)), one minor stroke (1/63 (1.6%)) and three incidents of intracranial hemorrhage in two subjects (2/63 (3.2%)) prior to the 12-month follow-up. There was one instance of mortality (1/63, 1.6%). Morbidity was 0% (0/63) and 1.8% (1/63) at the 12-month and 36-month follow-ups, respectively.ConclusionsLUNA AES is safe and effective for the treatment of bifurcation and sidewall aneurysms.Clinical trial registrationISRCTN72343080; Results.

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Cryoballoon Ablation for Persistent and Paroxysmal Atrial Fibrillation: Procedural Differences and Results from the Spanish Registry (RECABA)

10.22541/au.162525134.49788108/v1 ◽

2021 ◽

Author(s):

Ermengol Valles ◽

Jesus Jimenez ◽

Julio Martí-Almor ◽

Jorge Toquero ◽

Jose Ormaetxe ◽

...

Keyword(s):

Atrial Fibrillation ◽

Paroxysmal Atrial Fibrillation ◽

Structural Heart Disease ◽

Persistent Atrial Fibrillation ◽

Long Term Results ◽

Cryoballoon Ablation ◽

Arterial Line ◽

Post Market

Introduction: Cryoballoon ablation (CBA) has become a standard treatment for paroxysmal atrial fibrillation (PaAF) but limited data is available for outcomes in patients with persistent atrial fibrillation (PeAF). Methods: We analyzed the first 944 patients included in the Spanish Prospective Multi-center Observation Post-market Registry to compare characteristics and outcomes of patients undergoing CBA for PeAF versus PaAF. Results: A total of 944 patients (57.8±10.4 years; 70.1% male) with AF (27.9% persistent) were prospectively included from 25 centers. PeAF patients were more likely to have structural heart disease (67.7 vs 11.4%; p<0.001) and left atrium dilation (72.6 vs 43.3%; p<0.001). CBA of PeAF was less likely to be performed under general anesthesia (10.7 vs 22.2%; p<0.001), with an arterial line (32.2 vs 44.6%; p<0.001) and assisted transeptal puncture (11.9 vs 17.9%; p=0.025). During an application, PeAF patients had a longer time to -30°C (35.91±14.20 vs 34.93±12.87 sec; p=0.021) and a colder balloon nadir temperature during vein isolation (-35.04±9.58 vs -33.61±10.32ºC; p=0.004), but received fewer bonus freeze applications (30.7 vs 41.1%; p<0.001). There were no differences in acute pulmonary vein isolation and procedure-related complications. Overall, 76.7% of patients were free from AF recurrences at 15-month follow-up (78.9% in PaAF vs. 70.9% in PeAF; p=0.09). Conclusions: Patients with PeAF have a more diseased substrate, and CBA procedures performed in such patients were more simplified, although longer/colder freeze applications were often applied. The acute efficacy/safety profile of CBA was similar between PaAF and PeAF patients, but long-term results were better in PaAF patients.

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Long term follow-up from amplatzer cardiac plug European multicenter post market observational study

European Heart Journal ◽

10.1093/eurheartj/eht308.p2187 ◽

2013 ◽

Vol 34 (suppl 1) ◽

pp. P2187-P2187

Author(s):

H. Sievert ◽

W. Schillinger ◽

L. Lickfett ◽

J. R. Lopez-Minguez ◽

H. Omran ◽

...

Keyword(s):

Observational Study ◽

Post Market ◽

Long Term Follow Up

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Therapy and prevention for mental health: What if mental diseases are mostly not brain disorders?

Behavioral and Brain Sciences ◽

10.1017/s0140525x1800105x ◽

2019 ◽

Vol 42 ◽

Cited By ~ 2

Author(s):

John P. A. Ioannidis

Keyword(s):

Mental Health ◽

Mental Disease ◽

Brain Disorders ◽

Social Stressors ◽

Labor Education ◽

Mental Diseases ◽

Long Term Follow Up ◽

Political Decisions

AbstractNeurobiology-based interventions for mental diseases and searches for useful biomarkers of treatment response have largely failed. Clinical trials should assess interventions related to environmental and social stressors, with long-term follow-up; social rather than biological endpoints; personalized outcomes; and suitable cluster, adaptive, and n-of-1 designs. Labor, education, financial, and other social/political decisions should be evaluated for their impacts on mental disease.

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