scholarly journals Nocturnal dexmedetomidine alleviates post–intensive care syndrome following cardiac surgery: a prospective randomized controlled clinical trial

BMC Medicine ◽  
2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Chun-hui Dong ◽  
Chao-nan Gao ◽  
Xiao-hua An ◽  
Na Li ◽  
Le Yang ◽  
...  
Keyword(s):  
Cardiac Surgery ◽  
Intensive Care ◽  
Placebo Group ◽  
Study Endpoint ◽  
Primary Study ◽  
Link Type ◽  
Post Surgery ◽  
Psychological Impairment ◽  
Post Intensive Care Syndrome

Abstract Background Dexmedetomidine is a sedative agent that may have the potential to reduce the risk of post-intensive care syndrome (PICS). This study aimed to establish whether prophylactic nocturnal dexmedetomidine safely reduces postoperative PICS incidence and to develop an easy-to-use model for predicting the risk of PICS following cardiac surgery. Methods This was a single-center, double-blind, randomized, prospective, placebo-controlled trial. Patients undergoing cardiac surgery were randomly assigned (1:1) to dexmedetomidine or placebo (normal saline) groups between January 2019 and July 2020. Dexmedetomidine or a similar volume of saline was administered, with an infusion rate up to 1.2 μg/kg/h until the RASS remained between − 1 and 0. The primary study endpoint was PICS incidence at 6 months follow-up, as defined by cognitive, physical, or psychological impairments. Results We assessed 703 individuals for eligibility, of whom 508 were enrolled. Of these, there were 251 in the dexmedetomidine group and 257 in the placebo group that received the trial agent, forming a modified intention-to-treat population. PICS incidence at 6-month follow-up was significantly decreased in the dexmedetomidine group (54/251, 21.5%) relative to the placebo group (80/257, 31.1%) (odds ratio [OR] 0.793, 95% CI 0.665–0.945; p = 0.014). Psychological impairment was significantly reduced in the dexmedetomidine group relative to the placebo group (18.7% vs. 26.8%, OR 0.806, CI 0.672–0.967, p = 0.029). However, dexmedetomidine treatment was associated with a higher rate of hypotension. A nomogram revealed that age, education, a medical history of diabetes and smoking, dexmedetomidine treatment, postoperative atrial fibrillation, and sequential organ failure assessment scores at 8 h post-surgery were independent predictors of PICS. Conclusions Prophylactic nocturnal dexmedetomidine administration significantly reduced PICS incidence by a marked reduction in psychological impairment within a 6-month follow-up period. Trial registration ChiCTR, ChiCTR1800014314. Registered 5 January 2018, http://www.chictr.org.cn/index.aspx

Definition of the Responder to Hydroxyurea Therapy: Revisited.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 1513-1513 ◽  
Author(s):  
Samir K. Ballas ◽  
William F. McCarthy ◽  
Robert L Bauserman ◽  
Faramarz Valafar ◽  
Myron Waclawiw ◽  
...  
Keyword(s):  
Placebo Group ◽  
Sickle Cell ◽  
Sickle Cell Anemia ◽  
Adult Patients ◽  
Study Endpoint ◽  
Primary Study ◽  
Analgesic Use ◽  
Daily Pain ◽  
At Home

Abstract Abstract 1513 Poster Board I-536 Introduction Treatment of sickle cell anemia with hydroxyurea (HU) is associated with significant decreases in the frequency of painful crises, acute chest syndrome, morbidity, and mortality. Some patients, however, show no improvement even with prolonged HU therapy. Identifying treatment responders is important for predicting clinical improvements and for assessing the risk/benefit ratio of HU treatment for individual patients. The salutary effects of HU are thought to be the result of increasing the fetal hemoglobin (Hb F) level. NHLBI guidelines for sickle cell treatment define levels of 15%-20% Hb F as therapeutic endpoints. Research and reviews based on pediatric and adult patients have variously argued that levels from about 10% to 20% are beneficial. Patients and Methods Patients in this study were from the Multicenter Study of Hydroxyurea (MSH) in Sickle Cell Anemia, a randomized double-blind placebo controlled trial of HU. The N=299 adult patients were recruited from 21 sites across the U.S. and Canada, and were evenly distributed between males and females. Following randomization to placebo or HU, patients had biweekly follow-up visits until the trial was terminated early due to a significant reduction in painful crises (the primary study endpoint) in the HU arm. Levels of Hb F in MSH patients were assessed at baseline and again approximately 18-21 months after treatment began, with the level at each time being the average of two measurements. In the previously reported MSH study, patients were divided into quartiles of Hb F change as a measure of response to HU treatment. In this approach the bottom two quartiles showed either no or minimal positive change in Hb F levels, and fully overlapped with placebo group in the extent of change. We redefined HU patients as ‘responders’ or ‘nonresponders’ based on a 15% Hb F threshold; those with baseline HbF below 15% and follow-up above 15% were labeled ‘responders,’ while all others were labeled ‘nonresponders.’ The 15% level was chosen due to its frequent identification in previous publications as a level at which meaningful benefits could be expected. For both coding schemes, we compared the following outcomes between subgroups: rate of painful crises, proportion of days at home with pain and with opioid use, and average daily pain. Results Using the 15% rule, responders had significantly better outcomes than nonresponders on all outcome measures: rate of painful crises (p=.011), proportion of at-home days with pain (p=.025), proportion of days with analgesic use (p=.002), and average daily pain (p<.0001). Nonresponders, in turn, did not differ from the placebo group on any of these outcomes. Using the quartiles approach, the highest quartile had significantly fewer painful crises (p<.05) than the bottom two and placebo, but did not differ from the second highest; for the proportion of days with pain, the highest group did not differ from 2 of the other 3 quartiles or from the placebo group. Only for proportion of days with analgesic use and average daily pain did the highest quartile significantly differ from all other quartiles and from placebo patients. Finally, applying the 15% rule to the pl‘cebo group resulted in no placebo patients being mislabeled as treatment responders, suggesting that increases above the 15% cutoff for post-treatment Hb F levels is outside normal variability in sickle cell patients not in HU treatment. Conclusions The 15% Hb F rule successfully identified a ‘responder’ group that significantly differed from other HU patients and from placebo patients on all outcomes, including painful crises. Despite overlap with responders under the 15% rule, patients in the highest quartile for Hb F change did not consistently differ from all other quartiles or placebo on the primary outcome (painful crises) and on proportion of days with pain. Our data suggest that using the 15% Hb F threshold identifies a subset of patients with the best clinical outcomes. Disclosures No relevant conflicts of interest to declare.

scholarly journals Post-intensive care syndrome after a critical COVID-19: cohort study from a Belgian follow-up clinic

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Anne-Françoise Rousseau ◽  
Pauline Minguet ◽  
Camille Colson ◽  
Isabelle Kellens ◽  
Sourour Chaabane ◽  
...  
Keyword(s):  
Cohort Study ◽  
Intensive Care ◽  
Inpatient Rehabilitation ◽  
Quadriceps Strength ◽  
Biological Parameters ◽  
Icu Stay ◽  
Icu Discharge ◽  
Prolonged Icu Stay ◽  
Post Intensive Care Syndrome

Abstract Purpose Many patients with coronavirus disease 2019 (COVID-19) required critical care. Mid-term outcomes of the survivors need to be assessed. The objective of this single-center cohort study was to describe their physical, cognitive, psychological, and biological outcomes at 3 months following intensive care unit (ICU)-discharge (M3). Patients and methods All COVID-19 adults who survived an ICU stay ≥ 7 days and attended the M3 consultation at our multidisciplinary follow-up clinic were involved. They benefited from a standardized assessment, addressing health-related quality of life (EQ-5D-3L), sleep disorders (PSQI), and the three principal components of post-intensive care syndrome (PICS): physical status (Barthel index, handgrip and quadriceps strength), mental health disorders (HADS and IES-R), and cognitive impairment (MoCA). Biological parameters referred to C-reactive protein and creatinine. Results Among the 92 patients admitted to our ICU for COVID-19, 42 survived a prolonged ICU stay and 32 (80%) attended the M3 follow-up visit. Their median age was 62 [49–68] years, 72% were male, and nearly half received inpatient rehabilitation following ICU discharge. At M3, 87.5% (28/32) had not regained their baseline level of daily activities. Only 6.2% (2/32) fully recovered, and had normal scores for the three MoCA, IES-R and Barthel scores. The main observed disorders were PSQI > 5 (75%, 24/32), MoCA < 26 (44%, 14/32), Barthel < 100 (31%, 10/32) and IES-R ≥ 33 (28%, 9/32). Combined disorders were observed in 13/32 (40.6%) of the patients. The EQ-5D-3L visual scale was rated at 71 [61–80]. A quarter of patients (8/32) demonstrated a persistent inflammation based on CRP blood level (9.3 [6.8–17.7] mg/L). Conclusion The burden of severe COVID-19 and prolonged ICU stay was considerable in the present cohort after 3 months, affecting both functional status and biological parameters. These data are an argument on the need for closed follow-up for critically ill COVID-19 survivors.

Esmolol before cardioplegia and as cardioplegia adjuvant reduces cardiac troponin release after cardiac surgery. A randomized trial

Perfusion ◽  
2016 ◽  
Vol 32 (4) ◽  
pp. 313-320 ◽  
Author(s):  
Elena Bignami ◽  
Marcello Guarnieri ◽  
Annalisa Franco ◽  
Chiara Gerli ◽  
Monica De Luca ◽  
...  
Keyword(s):  
Intensive Care Unit ◽  
Cardiac Surgery ◽  
Intensive Care ◽  
Placebo Group ◽  
Cardiopulmonary Bypass ◽  
Hospital Stay ◽  
Troponin T ◽  
Mechanical Activity ◽  
Double Blind ◽  
Elective Cardiac Surgery

Background: Cardioplegic solutions are the standard in myocardial protection during cardiac surgery, since they interrupt the electro-mechanical activity of the heart and protect it from ischemia during aortic cross-clamping. Nevertheless, myocardial damage has a strong clinical impact. We tested the hypothesis that the short-acting beta-blocker esmolol, given immediately before cardiopulmonary bypass and as a cardioplegia additive, would provide an extra protection to myocardial tissue during cardiopulmonary bypass by virtually reducing myocardial activity and, therefore, oxygen consumption to zero. Materials and methods: This was a single-centre, double-blind, placebo-controlled, parallel-group phase IV trial. Adult patients undergoing elective valvular and non-valvular cardiac surgery with end diastolic diameter >60 mm and ejection fraction <50% were enrolled. Patients were randomly assigned to receive either esmolol, 1 mg/kg before aortic cross-clamping and 2 mg/kg with Custodiol® crystalloid cardioplegia or equivolume placebo. The primary end-point was peak postoperative troponin T concentration. Troponin was measured at Intensive Care Unit arrival and at 4, 24 and 48 hours. Secondary endpoints included ventricular fibrillation after cardioplegic arrest, need for inotropic support and intensive care unit and hospital stay. Results: We found a reduction in peak postoperative troponin T, from 1195 ng/l (690–2730) in the placebo group to 640 ng/l (544–1174) in the esmolol group (p=0.029) with no differences in Intensive Care Unit stay [3 days (1-6) in the placebo group and 3 days (2-5) in the esmolol group] and hospital stay [7 days (6–10) in the placebo group and 7 days (6–12) in the esmolol group]. Troponin peak occurred at 24 hours for 12 patients (26%) and at 4 hours for the others (74%). There were no differences in other secondary end-points. Conclusions: Adding esmolol to the cardioplegia in high-risk patients undergoing elective cardiac surgery reduces peak postoperative troponin levels. Further investigation is necessary to assess esmolol effects on major clinical outcomes.

Cerebral Oximetry Monitoring to Maintain Normal Cerebral Oxygen Saturation during High-risk Cardiac Surgery

2016 ◽  
Vol 124 (4) ◽  
pp. 826-836 ◽  
Author(s):  
Alain Deschamps ◽  
Richard Hall ◽  
Hilary Grocott ◽  
C. David Mazer ◽  
Peter T. Choi ◽  
...  
Keyword(s):  
Intensive Care Unit ◽  
Cardiac Surgery ◽  
Intensive Care ◽  
Intervention Group ◽  
Perioperative Outcomes ◽  
Control Group ◽  
Cerebral Oxygen ◽  
Cerebral Desaturation ◽  
Cerebral Saturation

Abstract Background Cerebral oxygen desaturation during cardiac surgery has been associated with adverse perioperative outcomes. Before a large multicenter randomized controlled trial (RCT) on the impact of preventing desaturations on perioperative outcomes, the authors undertook a randomized prospective, parallel-arm, multicenter feasibility RCT to determine whether an intervention algorithm could prevent desaturations. Methods Eight Canadian sites randomized 201 patients between April 2012 and October 2013. The primary outcome was the success rate of reversing cerebral desaturations below 10% relative to baseline in the intervention group. Anesthesiologists were blinded to the cerebral saturation values in the control group. Intensive care unit personnel were blinded to cerebral saturation values for both groups. Secondary outcomes included the area under the curve of cerebral desaturation load, enrolment rates, and a 30-day follow-up for adverse events. Results Cerebral desaturations occurred in 71 (70%) of the 102 intervention group patients and 56 (57%) of the 99 control group patients (P = 0.04). Reversal was successful in 69 (97%) of the intervention group patients. The mean cerebral desaturation load (SD) in the operating room was smaller for intervention group patients compared with control group patients (104 [217] %.min vs. 398 [869] %.min, mean difference, −294; 95% CI, −562 to −26; P = 0.03). This was also true in the intensive care unit (P = 0.02). There were no differences in adverse events between the groups. Conclusions Study sites were successful in reversal of desaturation, patient recruitment, randomization, and follow-up in cardiac surgery, supporting the feasibility of conducting a large multicenter RCT.

Long-Term Follow-Up of a Randomized Phase III Multicenter Study Comparing a Standard Versus an Intensified Conditioning Regimen for High-Dose Chemotherapy in Patients with Multiple Myeloma.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 945-945
Author(s):  
Roland Fenk ◽  
Peter Schneider ◽  
Martin Kropff ◽  
Ali-Nuri Huenerlituerkoglu ◽  
Ulrich Steidl ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Stem Cell ◽  
Conditioning Regimen ◽  
High Dose Chemotherapy ◽  
Phase Iii ◽  
Study Endpoint ◽  
Primary Study ◽  
High Dose ◽  
Significant Difference

Abstract High-dose chemotherapy (HDT) improves the outcome of patients with multiple myeloma (MM) in comparison to conventional chemotherapy. Dose-escalating strategies including tandem HDT are currently evaluated to further improve remission rates and survival of patients. Therefore we conducted a randomized multicenter trial to compare an intensified conditioning regimen with the current standard high-dose melphalan. The primary study endpoint was response rate, with overall survival (OS), event-free survival (EFS) and toxicity analysed as secondary endpoints. Between 1997 and 1999 a total of 56 patients with stage II and III disease, who were matched for age (median 56 years), number of previous therapies (median time from diagnosis to transplant 7 months) and different risk factors (beta2-microglobulin, LDH, CRP, cytogentic abnormalities, chemoresistant disease, IgA-subtype, renal impairment), were randomized. All patients received 2 courses of oral idarubicine/dexamethasone and 2 courses of intravenous cyclophosphamide/adriamycine in combination with G-CSF followed by peripheral stem cell collection. Thirty patients were treated with melphalan 200mg/m2 (HD-M) whereas 26 patients received idarubicine 42mg/m2, melphalan 200mg/m2 and cyclophosphamide 120mg/kg (HD-IMC) followed by autologous blood stem cell transplantation. Acute toxicity was higher with HD-IMC, including 5 (20%) treatment-related deaths due to infections versus none (0%) in the HD-M group. This lead to early termination of the study. Severity of mucositis (grade III-IV 19 vs. 8 pts., p=0.001), CRP (20 vs. 7 mg/dl, p<0.001), days of fever (11 vs. 3, p<0.001), days with iv-antibiotics (13 vs. 4, p<0.001), number of erythrocyte-transfusions (6 vs. 2, p<0.001), number of platelet-transfusions (16 vs. 4, p<0.001) and days to granulocyte engraftment (18 vs. 11, p=0.007) were significantly higher after HD-IMC. After a follow-up of 5 years analysis restricted to patients surviving the first 30 days after HDT showed a trend to higher response rates (CR+vgPR: 47% (95%CI 24–72%) vs. 35% (95%CI 18–56%), PR 37% (95%CI 17–63%) vs. 48% (95%CI 29–68%) and time-to-progression (median 31 vs. 15 months, p=0.1) in the HD-IMC treatment arm in comparison to HD-M, but there was no significant difference in EFS and OS (median 22 vs. 30, p= 0.31 and 66 vs. 66 months, p=0.8, respectively). Univariate analysis demonstrated that LDH levels > 200 U/L (p=0.04) and chemoresistant disease (p=0.05) were a bad prognostic factor for EFS. Beta2-Microglobulin levels > 5mg/dl (p=0.01), abnormal conventional cytogenetics (p=0.02) and LDH levels > 200 U/L (p=0.03) were predictive for an inferior OS. In conclusion intensified conditioning for HDT had an intolerable high treatment-related mortality and did not improve EFS and OS in patients with multiple myeloma.

Predictors Of The Post-Thrombotic Syndrome In a Large Cohort Of Patients With Proximal DVT: Secondary Analysis Of The Sox Trial

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 460-460
Author(s):  
Susan R. Kahn ◽  
Stan Shapiro ◽  
Philip S. Wells ◽  
Marc A Rodger ◽  
Michael J. Kovacs ◽  
...  
Keyword(s):  
Intervention Group ◽  
Secondary Analysis ◽  
Iliac Vein ◽  
Study Endpoint ◽  
Primary Study ◽  
Reference Category ◽  
Post Thrombotic Syndrome ◽  
Patient Reported ◽  
Category Score

Background The post-thrombotic syndrome (PTS) is a frequent complication of deep venous thrombosis (DVT). Identifying predictors of PTS is important to counsel DVT patients on their expected prognosis and to identify patients who may benefit from closer monitoring or preventive strategies. Objective In a secondary analysis of the SOX Trial, we aimed to identify predictors of developing PTS during 2 years follow-up after a first episode of proximal DVT. Methods The study cohort consisted of participants in the SOX Trial, a multicenter (24 centres in Canada and U.S.) randomized placebo controlled trial of active elastic compression stockings vs. placebo stockings worn for 2 years after a first, symptomatic proximal DVT. PTS, the primary study endpoint, was diagnosed at or after the 6 month visit based on patient-reported pain and swelling of ≥ 1 month duration that were typical in character, i.e. worse at end of day or after prolonged sitting/standing and improved after rest/leg elevation (Ginsberg criteria). Cumulative incidences of PTS were compared in subgroups defined by sex, age category, body mass index (BMI) category, anatomic extent of index DVT, type of DVT (cancer-associated, secondary risk factor-associated, unprovoked) and 1-month Villalta score category (score 0-4: none; 5-9, mild; 10-14, moderate; >14, severe), using Cox regression. Losses to follow-up, withdrawals and deaths were censored as of last date of follow-up. Results are presented as cumulative incidence by 750 days follow-up and hazard ratios (HR) with 95% confidence intervals (CI). Results Among the 803 participants in the SOX Trial, 60% were male, mean age was 55.1 years, and 87% were out-patients. In analyses adjusted for intervention group (i.e. allocation to active vs. placebo stockings), iliac vein DVT (HR 2.26 [95% CI 1.12, 4.53]; reference category: popliteal DVT) and Villalta score category at 1 month after DVT (score 5-9, HR 2.74 [95% CI 1.62, 4.64]; score 10-14, HR 5.81[95% CI 2.99, 11.29]; score >14, HR 7.59 [95% CI 3.31, 17.44]; reference category: score <5) were significant predictors of PTS. In analyses adjusted for intervention group and all predictor variables of interest, Villalta score category at 1 month was a highly statistically significant, independent predictor of PTS (see Table). Age, sex, BMI and type of DVT did not predict development of PTS. Conclusions In a large prospective cohort of patients with proximal DVT who were participants in the SOX Trial, Villalta score category (which reflects severity of venous symptoms and signs) at 1 month after DVT was strongly predictive of development of PTS during 2 years follow-up. This confirms a similar finding that we first observed in the VETO cohort study (Kahn SR et. al., Annals Intern Med 2008). More extensive DVT was also associated with PTS. Patients with these risk factors may benefit from closer monitoring after proximal DVT, and in the case of iliac vein DVT, from more aggressive strategies to treat acute DVT. Disclosures: No relevant conflicts of interest to declare.

Randomized phase III trial comparing vincristine, actinomycin, cyclophosphamide (VAC) with VAC/V topotecan/cyclophosphamide (TC) for intermediate risk rhabdomyosarcoma (IRRMS). D9803, COG study

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 9509-9509 ◽  
Author(s):  
C. A. Arndt ◽  
D. S. Hawkins ◽  
J. A. Stoner ◽  
M. D. Wharam ◽  
D. A. Rodeberg ◽  
...  
Keyword(s):  
Local Therapy ◽  
Phase Iii ◽  
Study Endpoint ◽  
Primary Study ◽  
Significant Activity ◽  
Undifferentiated Sarcoma ◽  
Primary Study Endpoint ◽  
Alpha Level ◽  
Adequate Organ Function

9509 Background: IRRMS was defined as nonmetastatic alveolar (A) RMS or undifferentiated sarcoma (UDS); stage (stg) 2 and 3, group (gr) III embryonal (E) RMS; stg 4 ERMS <10y. IRRMS had a 5 yr failure free survival (FFS) of 64% on IRS IV. Since T alone and with C has significant activity in RMS, we tested whether alternating VAC/VTC improved FFS for IRRMS compared with VAC alone. Methods: Patients (pts) < 50 y with IRRMS with adequate organ function were randomized to 39 wks of VAC (V=1.5 mg/m2, A=0.045 mg/kg, C=2.2 g/m2 q 3 wk) vs VAC alternating with VTC (T=0.75 mg/m2/d ×5, C=250 mg/m2/d ×5 q 3 wk), with additional wkly V; doses adjusted for age <3y; local therapy was after wk 12. Pts with parameningeal RMS/meningeal extension (PME) were nonrandomly treated with VAC and immediate XRT. Primary study endpoint was FFS. The study was designed with 80% power (5% 2-sided alpha level) to detect an increase in 5 yr FFS from 64% to 75%, a relative risk (RR) of 0.64, with VAC/VTC, requiring 518 randomized pts. Results reflect the 3rd of 4 planned analyses (75% information); O'Brien Fleming adjusted alpha level is 0.0166; and Cox PH model was used. Results: 620 eligible pts were entered from 9/99 to 8/05: 266 randomized to VAC, 253 to VAC/VTC, 101 PME patients were nonrandomly treated with VAC. Treatment strata were ERMS stg 2/3, gr III 37%; ERMS grp IV <10 y 6%; ARMS/UDS stg 1 or gr I 16%; ARMS/UDS other 25%; PME 16%. 3% of pts were <1 y, 69% 1–9 y, 28% ≥10 y; 13% of pts were stg 1; 26% stg 2; 54% stg 3; 7% stg 4. 77% pts had gr III tumors. Primary tumor sites were PM in 35% pts, extremity 15%, bladder/prostate 16%, retroperitoneal/perineal 15%, other 19%. Median follow up is 2.4 yrs. FFS at 2 yrs is 77% with VAC and 72% with VAC/VTC. Observed data are inconsistent with hypothesized improvement under VAC/VTC (RR=1.20, 98.34% CI: 0.78–1.85, p=0.3). Similar patients on IRS IV had 2 yr FFS of 77%. 2 yr survival (OS) with VAC: 91%; VAC/VTC: 87% (RR=0.94, CI: 0.55–1.59, p=0.8). There were 12 2nd malignancies and 10 deaths as first events. 4 of 10 deaths were from hepatopathy, which decreased in incidence following dose changes for A and C. Conclusions: In IRRMS, VAC/VTC does not significantly improve FFS nor OS versus VAC, and outcome is similar to IRS IV. No significant financial relationships to disclose.

Rotational and aspiration atherectomy for infrainguinal in-stent restenosis

VASA ◽  
2013 ◽  
Vol 42 (2) ◽  
pp. 127-133 ◽  
Author(s):  
Ulrich Beschorner ◽  
Hans Krankenberg ◽  
Dierk Scheinert ◽  
Horst Sievert ◽  
Thilo Tübler ◽  
...  
Keyword(s):  
Ankle Brachial Index ◽  
Primary Patency ◽  
Study Endpoint ◽  
Primary Study ◽  
Lesion Length ◽  
Secondary Patency ◽  
Peripheral Vascular ◽  
Stent Restenosis ◽  
In Stent Restenosis

Background: To report feasibility and safety of the Pathway PV™ Atherectomy System during percutaneous peripheral vascular interventions of in-stent restenosis. Patients and methods: 33 patients (66.7 % men; mean age 68.7 years; 39.4 % diabetics) with symptomatic infrainguinal in-stent restenosis were enrolled at 5 study sites. Primary study endpoint was the 30-day serious adverse event (SAE) rate. At one study site a subgroup of 13 patients was scheduled for additional follow-up examinations with duplex Results: Forty lesions with a mean lesion length of 85.7 mm (range 6 - 370 mm) were treated including total occlusions (20 %) and infrapopliteal lesions (5 %). In sixteen target lesions (40 %) procedural success was reached with atherectomy alone, 23 lesions (57.5 %) received adjunctive percutaneous transluminal angioplasty to obtain a sufficient angiographic result. Freedom from device-related SAEs was 100 %. Overall there were 11 unexpected adverse events in 11 patients, two of which were serious (retroperitoneal bleeding and access site infection). The ankle-brachial index increased significantly from 0.65 ± 0.13 at baseline to 0.82 ± 0.15 at 30 days. Mean Rutherford category improved from 2.8 ± 0.7 at baseline to 1.0 ± 1.2. In the subgroup with longer follow- up primary patency was 33 % after 12 months and 25 % after 24 months. Secondary patency was 92 % after 12 and 24 months. Conclusions: The use of the Pathway PV™ System during percutaneous peripheral vascular interventions of in-stent restenosis appears to be feasible and safe but does not seem to offer a sustainable solution regarding long term patency. A combination with drug eluting balloon angioplasty could be an interesting option and should be evaluated in further clinical trials.

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