Off-the-Shelf Devices for Treatment of Thoracic Aortic Diseases: Midterm Follow-up of TEVAR With Chimneys or Physician-Made Fenestrations

2019 ◽  
Vol 27 (1) ◽  
pp. 132-142 ◽  
Author(s):  
Lei Zhang ◽  
Meng-tao Wu ◽  
Guang-lang Zhu ◽  
Jia-xuan Feng ◽  
Chao Song ◽  
...  
Keyword(s):  
Type I ◽  
Aortic Diseases ◽  
Stent Grafts ◽  
Primary Endpoints ◽  
Type I Endoleak ◽  
Secondary Endpoints ◽  
Aortic Arch Repair ◽  
Low Incidence ◽  
Graft Migration

Purpose: To evaluate the midterm outcomes of thoracic endovascular aortic repair (TEVAR) using chimney grafts (ch-TEVAR) or thoracic stent-grafts with fenestrations made on the back table (f-TEVAR) to treat thoracic aortic dissection (TAD) and thoracic aortic aneurysm (TAA). Materials and Methods: A retrospective analysis was conducted of 474 consecutive patients (mean age 62.3±10.7 years; 346 men) treated with either f-TEVAR (n=110) or ch-TEVAR (n=364) for 352 TADs (81 f-TEVAR and 271 ch-TEVAR) or 122 TAAs (29 f-TEVAR and 93 ch-TEVAR) from 2008 to 2016. The primary endpoints at 30 days and during follow-up were overall mortality, aorta-related mortality, and major complications. The secondary endpoints were endoleak and reintervention. The patency of the target branches, cost of hospitalization, and the use of antiplatelet drugs were also analyzed. Results: Intraoperative type I endoleaks were treated in 69 (14.6%) cases (4 f-TEVAR and 65 ch-TEVAR, p<0.01) to achieve 100% technical success. Four (0.8%) patients died within 30 days [1 (0.9%) f-TEVAR and 3 (0.8%) ch-TEVAR]. Perioperative cerebral ischemia (1 fatal stroke) occurred in 9 (1.9%) patients: (1 f-TEVAR and 8 ch-TEVAR, p=0.39). During the mean follow-up of 50.6±20.0 months (49.5±18.3 months in f-TEVAR and 50.9±20.6 months in ch-TEVAR), 11 (2.3%) patients died of an aorta-related event. Type I endoleak was present in 40 (8.4%) patients (1 f-TEVAR and 39 ch-TEVAR, p<0.01). Eleven (2.3%) patients experienced stent-graft migration and 13 (2.7%) had a retrograde dissection. One hundred (16.9%) of the 593 branch stents occluded (4/75 in the f-TEVAR group and 96/518 in the ch-TEVAR group, p<0.01). The branch reintervention rate was 7.2% (34/474). The f-TEVAR group had a significantly higher probability of freedom from branch occlusion (92%) than the ch-TEVAR group (83%, p=0.007). Conclusion: Off-the-shelf techniques employing chimney grafts and homemade fenestrations are both suitable options for TAD and TAA involving the supra-aortic branches, with a low incidence of reintervention. Fenestrated TEVAR seems to have more favorable short- and midterm outcomes. Further study of these off-the-shelf techniques for aortic arch repair is warranted.

Type IIIb Endoleak After Endovascular Aneurysm Repair Using the Zenith Stent Graft

2019 ◽  
Vol 53 (6) ◽  
pp. 515-519
Author(s):  
Toshiya Nishibe ◽  
Toru Iwahashi ◽  
Kentaro Kamiya ◽  
Masaki Kano ◽  
Keita Maruno ◽  
...  
Keyword(s):  
Stent Graft ◽  
Endovascular Aneurysm Repair ◽  
Aneurysm Rupture ◽  
Type I ◽  
Stent Grafts ◽  
System Type ◽  
Type Iiib ◽  
Type I Endoleak ◽  
Aneurysm Repair

We present 3 cases of type IIIb endoleak after endovascular aneurysm repair (EVAR) using the Zenith stent graft system. Type III endoleak, like type I endoleak, is a high-pressure, high-risk leak that increases sac pressure up to or even above arterial pressure, and is associated with an increased frequency of open conversions or risk of aneurysm rupture. Type IIIb endoleak is rare but there is much concern that the incidence of type IIIb endoleak is likely to increase hereafter; the mechanism of type IIIb endoleak is deterioration of graft fabric in conjunction with stent sutures. Type IIIb endoleak is difficult to diagnose before rupture. The possibility of type IIIb endoleak should be highly suspected when the continued growth of an excluded aneurysm sac without direct radiologic evidence is observed during follow-up. Type IIIb endoleak can be repaired by relining of the stent graft with additional stent grafts.

Matched-Pair Analysis of Conventional versus Endoluminal AAA Treatment Outcomes during the Initial Phase of an Aortic Endografting Program

2000 ◽  
Vol 7 (2) ◽  
pp. 94-100 ◽  
Author(s):  
Tina U. Cohnert ◽  
Frank Oelert ◽  
Thorsten Wahlers ◽  
Bernhard Gohrbandt ◽  
Ajay Chavan ◽  
...  
Keyword(s):  
Perioperative Period ◽  
Matched Pair ◽  
Control Group ◽  
Type I ◽  
Type Ii ◽  
Stent Grafts ◽  
Infrarenal Aortic Aneurysm ◽  
Matched Pair Analysis ◽  
Type I Endoleak

Purpose: To investigate whether endovascular stent-grafts implanted during the early phase of an aortic endografting program have advantages over conventional surgical procedures for treatment of infrarenal aortic aneurysm (AAA). Methods: In the first months of an endografting program, 37 patients (36 men; mean age 67.9 ± 7.1 years, range 55 to 86) underwent AAA repair with endovascular implantation of a Vanguard (n = 17) or Talent (n = 20) bifurcated stent-graft. Data collected during the perioperative period and in follow-up were compared retrospectively to a matched group of 37 elective surgical patients. Results: All endograft implantations were completed. Two type I and 6 type II endoleaks (21.6%) were seen postoperatively. Five type II sealed without intervention; 1 type I endoleak was corrected with an additional stent, but 1 type I and 1 type II endoleaks persisted despite attempts with coil embolization. Two (5.4%) endograft patients died during the perioperative period; however, this was not significantly different (p = 0.15) from the control group. In the mean follow-up of 12 ± 6 months for both groups, 1 (2.7%) late conversion was necessary at 2 years for aneurysm expansion in an endograft patient with an unsealed type I endoleak. Conclusions: In our learning curve experience with aortic endografting, postoperative morbidity and mortality were higher in endograft patients compared to conventionally treated controls. Only in the endograft group was reoperation required during follow-up. Careful monitoring with periodic imaging studies is mandatory after endoluminal AAA treatment.

Homemade Fenestrated Stent-Grafts for Complete Endovascular Repair of Aortic Arch Dissections

2019 ◽  
Vol 26 (5) ◽  
pp. 645-651 ◽  
Author(s):  
Ludovic Canaud ◽  
Baris Ata Ozdemir ◽  
Lucien Chassin-Trubert ◽  
Julien Sfeir ◽  
Pierre Alric ◽  
...  
Keyword(s):  
Aortic Arch ◽  
Stent Graft ◽  
Endovascular Repair ◽  
Covered Stent ◽  
Type I ◽  
Type Ii ◽  
Stent Grafts ◽  
Fenestrated Stent Graft ◽  
Type I Endoleak

Purpose: To evaluate outcomes of homemade fenestrated stent-grafts for complete endovascular aortic repair of aortic arch dissections. Materials and Methods: From July 2014 through September 2018, 35 patients (mean age 66±11 years; 25 men) underwent homemade fenestrated stent-graft repair of acute (n=16) or chronic (n=10) complicated type B aortic dissections (n=16) and dissecting aortic arch aneurysms subsequent to surgical treatment of acute type A dissections (n=9). Nineteen (54%) procedures were emergent. Results: Zone 2 single-fenestrated stent-grafts were used in 25 cases; the remaining 10 were double-fenestrated stent-grafts deployed in zone 0. Median time for stent-graft modification was 18 minutes (range 16–20). Technical success was achieved in all cases. An immediate distal type I endoleak was treated intraoperatively. Among the double-fenestrated stent-graft cases, the left subclavian artery fenestration could not be cannulated in 2 patients and revascularization was required. Partial coverage of the left common carotid artery necessitated placement of a covered stent in 3 cases. One (3%) patient had a stroke without permanent sequelae. Two type II endoleaks required additional covered stent placement at 5 and 7 days postoperatively, respectively. The 30-day mortality was 6% (2 patients with ruptured aortic arch aneurysm). During a mean follow-up of 17.6±13 months, there was no aortic rupture or retrograde dissection. One late type I endoleak was treated with additional proximal fenestrated stent-graft placement. One type II endoleak is currently under observation. One additional patient died (unrelated to the aorta); overall mortality was 9%. All supra-aortic trunks were patent. Conclusion: The use of homemade fenestrated stent-grafts for endovascular repair of aortic arch dissections is feasible and effective for total endovascular aortic arch repair. Durability concerns will need to be assessed in additional studies with long-term follow-up.

scholarly journals Mid- and Long-Term Effects of Endovascular Surgery and Hybrid Procedures for Complex Aortic Diseases

2019 ◽  
Vol 2019 ◽  
pp. 1-5
Author(s):  
Jiasheng Xu ◽  
Yu Zhou ◽  
Jingjing Guo ◽  
Yu Huang ◽  
Yangkai Jiang ◽  
...  
Keyword(s):  
Aortic Dissection ◽  
Stent Graft ◽  
Endovascular Surgery ◽  
Special Treatment ◽  
Type I ◽  
Aortic Diseases ◽  
Hybrid Procedures ◽  
Type I Endoleak

Objective. To assess the efficacy and short- and mid-term results of endovascular surgery and hybrid surgical procedures in treatment of complex aortic dissection. Methods. Clinical data of 90 patients with complex aortic dissection admitted from June 2012 to June 2018 were retrospectively analyzed. Among the patients, 60 cases were male and 30 cases were female, and their ages were ranged from 32 to 79, with an average age of 55 years old; different endovascular techniques and/or hybrid procedures were performed in these patients. Results. Technical success rate was 100% for the entire group of patients. Type I endoleak occurred in 8 patients immediately after stent-graft placement, which in 2 cases disappeared after a proximal Cuff placement, and the other cases received no special treatment. Follow-up was conducted from 1 month to 72 months, with an average of 36.3 months, and no stent-graft migration or organ ischemia was noted. In the follow-up patients, no type I endoleak occurred but type II endoleak was found in 2 cases, which were cured without treatment; no patient had paraplegia. Conclusion. Endovascular surgery and hybrid procedures have demonstrable mid- and long-term efficacy in treatment of complex aortic diseases. However, this conclusion still requires multicenter, large-sample studies to further confirm.

Treatment of a type Ia endoleak following EVAR using a custom-made inner branch device.

Vascular ◽  
2021 ◽  
pp. 170853812110627
Author(s):  
Gino Gemayel GG ◽  
Michel Montessuit MM ◽  
Anouche Gemayel GA
Keyword(s):  
Abdominal Aortic Aneurysm ◽  
Open Surgery ◽  
Type I ◽  
Novel Technology ◽  
Abdominal Aortic ◽  
Custom Made ◽  
Type Ia ◽  
Type I Endoleak ◽  
Aortic Cuff

Objectives We represent two cases of late proximal type I endoleak following EVAR with aneurysm expansion that were treated with a custom-made graft with inner branches. Methods Two patients of 87 and 82 years old were operated by EVAR 6 and 8 years ago for abdominal aortic aneurysm. Both had proximal type I endoleak with aneurysm sac expansion. Open surgery had a high risk, and a proximal aortic extension with a simple aortic cuff was not possible neither because previous EVAR grafts were already at the level of the renal arteries. A custom-made endograft with inner branches was planned as a fenestrated graft was not technically possible. Results We successfully treated both patients using a custom-made graft with four inner branches from Jotec (Cryolife, Kennesaw, GA). Three months’ follow-up CT scan did not show any endoleaks. All target vessels were patent with good conformability of the bridging stents. Conclusion The treatment of proximal type I endoleak using inner branches’ endografts is feasible. This novel technology might broaden the indications for complex aortic repair in a group of patients where fenestrated endografts are not possible.

Real-World Experience with Type I Endoleaks after Endovascular Repair of the Thoracic Aorta

2010 ◽  
Vol 76 (6) ◽  
pp. 599-605 ◽  
Author(s):  
Joshua D. Adams ◽  
Margaret C. Tracci ◽  
Sahir Sabri ◽  
Kenneth J. Cherry ◽  
John F. Angle ◽  
...  
Keyword(s):  
Natural History ◽  
Thoracic Endovascular Aortic Repair ◽  
Spontaneous Resolution ◽  
Type I ◽  
Single Center ◽  
Type I Endoleak ◽  
History Of ◽  
Aortic Pathologies ◽  
Initial Results

Endoleaks are a frequent complication of thoracic endovascular aortic repair (TEVAR) and will likely increase in incidence with application of the technique to more complicated aortic anatomy and a wider range of thoracic aortic pathologies. Management generally consists of aggressive repair of Type I endoleaks; however, the natural history of Type I endoleaks after TEVAR remains largely unknown. The purpose of this study was to examine the incidence and characteristics of Type I endoleaks and to evaluate clinical outcomes of patients with Type I endoleaks after TEVAR. A single-center retrospective review was performed on all patients who underwent TEVAR over a 4-year period. Type I endoleaks were detected in 21 per cent (27 of 129) of patients on post-deployment aortography or CT angiography. During a mean follow-up of 750.63 ± 483 days, 59 per cent (16 of 27) closed spontaneously; 30 per cent (eight of 27) required secondary endovascular intervention; and 11 per cent (three of 27) have persisted with no increase in maximum aortic diameter. No patients have died or required open surgical conversion as a result of their Type I endoleak. Although accurate predictors of spontaneous resolution of Type I endoleaks have yet to be definitively characterized, our initial results suggest that it may be safe to observe small Type I endoleaks given that a large percentage resolve spontaneously and no endoleak-related deaths have occurred.

Secondary Procedures Following Iliac Branch Device Treatment of Aneurysms Involving the Iliac Bifurcation: The pELVIS Registry

2017 ◽  
Vol 24 (3) ◽  
pp. 405-410 ◽  
Author(s):  
Konstantinos P. Donas ◽  
Mirjam Inchingolo ◽  
Piergiorgio Cao ◽  
Carlo Pratesi ◽  
Giovanni Pratesi ◽  
...  
Keyword(s):  
Specific Treatment ◽  
The Other ◽  
Type I ◽  
Iliac Arteries ◽  
Type I Endoleak ◽  
Secondary Procedures ◽  
Sealing Zone ◽  
Crossover Bypass ◽  
Iliac Bifurcation

Purpose: To evaluate the incidence and reasons for secondary procedures in patients treated with iliac branch devices (IBDs) for isolated iliac aneurysm or aortoiliac aneurysms involving the iliac bifurcation. Methods: Between January 2005 and December 2015, 575 surgical-high-risk patients (mean age 72.0±8.4 years; 558 men) with isolated iliac aneurysms (n=79) or aortoiliac aneurysms involving the iliac bifurcation (n=496) were treated with placement of 650 ZBIS or Gore IBDs (75 bilateral) in 6 European centers. The primary outcome was procedure-related reinterventions for occlusion or high-grade (>70%) stenosis of the bridging device, occlusion of the ipsilateral common or external iliac artery (EIA), type I/III endoleak, rupture, or infection following IBD implantation. Clinical and radiological data were analyzed based on preset definitions of comorbidities, aneurysm morphology, intraoperative variables, and follow-up strategies. Results: Nine (1.6%) reinterventions were performed within 30 days for occlusion or endoleak. Among 10 (1.5%) occluded EIAs ipsilateral to a deployed IBD, 6 underwent a reintervention with additional stent placement after thrombolysis (n=4) or a femorofemoral or iliofemoral crossover bypass (n=2). Three of 14 patients with early type I endoleak had a reintervention for an insufficient proximal sealing zone (stent-grafts in 2 common iliac arteries and 1 bifurcated endograft). Mean clinical and radiological follow-up were 32.6±9.9 and 29.8±21.1 months, respectively. Forty-two (7.3%) patients underwent reinterventions in the follow-up period. The overall postoperative reintervention rate was 8.9%. Both external and common iliac segments occluded in 30 (4.6%) IBDs; 2 patients had a crossover bypass and 14 were treated with endovascular techniques. In the other 14 patients, no specific treatment was performed. Seven (1.2%) patients with isolated EIA occlusion were treated during follow-up. Nineteen of the overall 28 patients with type I endoleak underwent endovascular repair. The other 9 were under radiological surveillance due to less significant (<5 mm) sac increase. No reintervention was performed to recanalize 11 (1.6%) occluded internal iliac arteries. Conclusion: Midterm experience with placement of IBDs is associated with a low incidence of secondary procedures due to type I endoleaks and occlusions. The main reasons for reinterventions seem to be short proximal sealing zone and poor conformability of the ZBIS device in elongated EIAs.

PS01.072: IT IS NOT ALWAYS RISKY USING MESH IN THE TREATMENT OF HIATAL HERNIA

2018 ◽  
Vol 31 (Supplement_1) ◽  
pp. 69-69
Author(s):  
Maximiliano Loviscek ◽  
Mauro Acosta ◽  
Oscar Crespin ◽  
Guido Orbe ◽  
Cesar Villamil ◽  
...  
Keyword(s):  
Hiatal Hernia ◽  
Conflicts Of Interest ◽  
Synthetic Mesh ◽  
Gastric Erosion ◽  
Type I ◽  
Intrathoracic Stomach ◽  
Type Iii ◽  
Type Iv ◽  
Low Incidence

Abstract Background Many studies have shown that the importance of using mesh for paraesophageal hernia repair (PEHR) is to prevent recurrence. Unfortunately, it is associated with high risk of complications such as esophageal or gastric erosion. The aim of this study is to report the results of 38 patients who underwent laparoscopic PEHR with the use of a BioSynthetic mesh (GoreÒ Bio AÒ tissue Reinforcement.USA). Methods Observational, retrospective, single-center cohort study. We analysed retrospectively 38 consecutive patients with diagnosis of symptomatic Hiatal Hernia (HH) treated laparoscopically with an absorbable BioSynthetic mesh, between 2011–2017. The classic radiologic classification was used to classify the HH before surgery. This classification consists in four types/stages (I-IV). I: Sliding HH, II: Paraesophageal HH, III: Mixed form and IV: Intrathoracic stomach—upside-down hernia. All patients with Type III—IV hiatal hernia who underwent laparoscopic PEHR using an absorbable BioSynthetic mesh were included. We evaluated the results after PEHR with a symptoms questionnaire using a score 0–4 (Likert scale) and with an esophagogram and an esophagogastroduodenoscopy (EGD) analyzing the surgical success. Success was considered with symptomatic score improvement and/or absence of any symptomatic HH at the esophagogram and/or EGD. Results 38 patients: 7 males and 31 women. Median age: 66 (range 40–71). 12/38 (31,6%) patients had a type III HH and 26/38 (68,4%) a type IV. All these patients had been treated with a laparoscopic PEHR, using an absorbable BioSynthetic mesh as a reinforcement of the crura and Nissen fundoplication. The median follow-up was 12 months. 16/38 (42%) had a follow-up > 24 months. Success was evident in 95% of the patients. We observed 2 recurrences, one with a symptomatic type I HH and the other with an early type III HH recurrence. Conclusion The use of an absorbable synthetic mesh as a reinforcement of the crura in the treatment of the PEH has encouraging good results in the mild term follow up, with an extremely low incidence of complications. Disclosure All authors have declared no conflicts of interest.

Survival analyses of adjuvant or neoadjuvant combination of a taxane plus cisplatin and 5-fluorouracil (T-PF) in patients with bulky nodal metastases from squamous cell carcinoma of the penis (PSCC): Results of a single high-volume center.

2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 377-377 ◽  
Author(s):  
Patrizia Giannatempo ◽  
Anna Paganoni ◽  
Laura Sangalli ◽  
Maurizio Colecchia ◽  
Luigi Piva ◽  
...  
Keyword(s):  
Progression Free Survival ◽  
High Volume ◽  
Wilcoxon Test ◽  
Nodal Metastases ◽  
Primary Endpoints ◽  
Negative Prognostic Factor ◽  
High Volume Center ◽  
Secondary Endpoints ◽  
P53 Status

377 Background: Bulky nodal metastases (N2-N3) of PSCC represent a negative prognostic factor, yet efficacy of multimodal treatment is not defined. For these patients (pts) we explore T-PF combination in adjuvant and neo-adjuvant setting. Methods: Paclitaxel (120 mg/m2, d1) or docetaxel (75 mg/m2 d1) plus cisplatin (75-100 mg/m2 d1) and 5-fluorouracil (5FU, 750-1000 mg/m2 96h d1) were scheduled prior to or following radical inguino-pelvic dissections in N2-3 M0 pts, according to protocol indications. Primary endpoints were overall (OS) and progression-free survival (PFS); safety and response-rate represented secondary endpoints. Association of survival with treatment setting and pre-specified covariates was explored. Results: From 6/2004 to 10/2012, 47 consecutive pts received neoadjuvant (N=28) or adjuvant (N=19) T-PF. 18 (38.3%) were disease-free after a median follow-up (FU) of 22 mos (IQR 17-42). Durable remissions were more frequently observed in adjuvant (52.6%; median FU: 42 mos) than in neoadjuvant group (28.6%; median FU: 17 mos). Distribution of OS and PFS were statistically in favour of adjuvant T-PF (p=0.01 at Wilcoxon test; p=0.008 at t test). However, Kaplan-Meyer curves did not show significant differences. A model including therapy setting, N category, laterality, pelvic extent and p53 status showed that only adjuvant administration was associated with improved OS (p=0.008), while adjuvant therapy (p=0.002), pelvic extent (p=0.029) and laterality (p=0.086) were associated with PFS. In neoadjuvant group we recorded 43% responses (complete [CR] and partial) and 4 (14%) pathologic CR. Surgery was possible in 18 (64.3%) pts, independently of response. Neither OS nor PFS were associated with response. Tolerability was mild to moderate. Conclusions: Adjuvant chemotherapy was the most important favourable predictor of OS and PFS. Adjuvant T-PF results are among the best available ones. Neoadjuvant T-PF compares with other recent schedules in terms of activity and efficacy. Surgery remains the mainstay treatment for resectable nodal metastases from PSCC.

scholarly journals Early but not late convalescent plasma is associated with better survival in moderate-to-severe COVID-19

2021 ◽  
Author(s):  
Neima Briggs ◽  
Michael V Gormally ◽  
Fangyong Li ◽  
Sabrina L Browning ◽  
Miriam M Treggiari ◽  
...  
Keyword(s):  
Hospital Mortality ◽  
Research Question ◽  
Severe Disease ◽  
Length Of Hospital Stay ◽  
Primary Endpoints ◽  
Before And After ◽  
Secondary Endpoints ◽  
Design And Methods ◽  
Hospital Days

Background: Limited therapeutic options exist for coronavirus disease 2019 (COVID-19). COVID-19 convalescent plasma (CCP) is a potential therapeutic, but there is limited data for patients with moderate-to-severe disease. Research Question: What are outcomes associated with administration of CCP in patients with moderate-to-severe COVID-19 infection? Study Design and Methods: We conducted a propensity score-matched analysis of patients with moderate-to-severe COVID-19. The primary endpoints were in-hospital mortality. Secondary endpoints were number of days alive and ventilator-free at 30 days; length of hospital stay; and change in WHO scores from CCP administration (or index date) to discharge. Of 151 patients who received CCP, 132 had complete follow-up data. Patients were transfused after a median of 6 hospital days; thus, we investigated the effect of convalescent plasma before and after this timepoint with 77 early (within 6 days) and 55 late (after 6 days) recipients. Among 3,217 inpatients who did not receive CCP, 2,551 were available for matching. Results: Early CCP recipients, of whom 31 (40%) were on mechanical ventilation, had lower 14-day (15% vs 23%) and 30-day (38% vs 49%) mortality compared to a matched unexposed cohort, with nearly 50% lower likelihood of in-hospital mortality (HR 0.52, [95% CI 0.28-0.96]; P=0.036). Early plasma recipients had more days alive and ventilator-free at 30 days (+3.3 days, [95% CI 0.2 to 6.3 days]; P=0.04) and improved WHO scores at 7 days (-0.8, [95% CI: -1.2 to -0.4]; P=0.0003) and hospital discharge (-0.9, [95% CI: -1.5 to -0.3]; P=0.004) compared to the matched unexposed cohort. No clinical differences were observed in late plasma recipients. Interpretation: Early administration of CCP improves outcomes in patients with moderate-to-severe COVID-19, while improvement was not observed with late CCP administration. The importance of timing of administration should be addressed in specifically designed trials.

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