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Despite continual improvement in the methods and devices used for treatment of proximal femoral fractures, unacceptably high failure rates remain. Novel screw-blade implant systems, combining a lag screw with a blade - the latter adding rotational stability to the femoral head - offer improvement of osseous purchase, especially in osteoporotic bone. The aim of this study was to compare biomechanically the head element (HE) anchorage of two screw-blade implant systems differing in blade orientation in the femoral head - vertical versus horizontal.
Twenty paired human cadaveric femoral heads were assigned to four groups (n=10), implanted with either Rotationally Stable Screw-Anchor HE (RoSA-HE, vertical blade orientation) or Gamma3 Rotation Control Lag Screw (Gamma-RC, horizontal blade orientation) in center or off-center position, and biomechanically tested until failure under progressively increasing cyclic loading at 2 Hz.
Cycles to failure and failure load were significantly higher for Gamma-RC versus. As the stability of the implant system with horizontal blade orientation drops sharply in off-center position, central insertion is its placement of choice.
Osteonecrosis of the femoral head (ONFH) can occur after traumatic injuries of the hip. Surgical treatment with total hip arthroplasty (THA) may not produce lifelong viability in younger patients. Free vascularized fibular graft (FVFG) has become a reliable method to delay or even avoid THA in this patient population by aiming to correct loss of viable bone through vascularized autologous bone transfer. The purpose of this study was to evaluate the longevity and outcomes of FVFG for traumatic hip injuries resulting in ONFH.
We performed a retrospective review of our institutional database of patients who had undergone FVFG from 1980-2006 for post-traumatic ONFH and had a minimum follow-up of 5 years. Data collected included demographics, pre-operative Urbaniak ONFH staging, Harris Hip scores (HHS), SF-12 scores, and conversion to THA.
Seventy-two hips in 68 patients met inclusion criteria. Mean follow-up was 11.6 years (range 5.1-33.2 years). Etiology included femoral neck fracture in 36 patients (61%),ceptable overall THA conversion rate at mid to long term follow-up in Urbaniak stage I through IV hips. FVFG remains a viable option for treatment in younger patients with pre- and post-collapse (stage IV) ONFH lesions secondary to hip trauma.
This study sought to elucidate the clinical impact and prognosis of stent graft (SG) thrombosis.
The VIABAHN SG offers a favorable outcome in long peripheral artery occlusive disease (PAOD) lesions in the femoropopliteal artery. One concern after SG deployment is the incidence of stent thrombosis and consequent acute limb ischemia (ALI).
In this retrospective multicenter study, we collected the clinical data of PAOD patients treated with VIABAHN SG who subsequently experienced SG thrombosis. The clinical symptoms of SG thrombosis, patency after reintervention, and predictors of loss of patency after reintervention were examined.
VIABAHN SGs were used for 1,215 patients; SG thrombosis occurred in 159 (13%) patients at a median of 6.4 months (interquartile range 2.8 to 13.5 months) after SG implantation; 21 (13%) patients presented with ALI. A total of 131 (82%) patients underwent reintervention for SG thrombosis, whereas 2 (1%) underwent primary major amputation and the remaining 26 (16%) were treated conservatively. The patency rate 1 year after reintervention, freedom from major adverse limb events, and limb salvage after reintervention were 54.9%, 73.6%, and 92.5%, respectively. Critical limb-threatening ischemia at SG implantation and ALI presentation at SG thrombosis were positively associated with an increased risk of rethrombosis, whereas distal stent diameter was negatively associated with the risk of rethrombosis.
SG thrombosis is associated with a considerable risk of ALI, but the risk of primary major amputation was not high. Clinical outcomes after reinterventions for thrombosed SGs were suboptimal.
SG thrombosis is associated with a considerable risk of ALI, but the risk of primary major amputation was not high. Clinical outcomes after reinterventions for thrombosed SGs were suboptimal.
This study sought to evaluate the safety and effectiveness of the Ranger drug-coated balloon (DCB) (paclitaxel dose density 2μg/mm
) for treating superficial femoral artery or proximal popliteal artery lesions.
Paclitaxel-coated balloon treatment prevents reinterventions, but dose and coating characteristics differ among balloons and necessitate discrete confirmation of safety and effectiveness.
Patients with symptomatic lower limb ischemia (Rutherford classification 2 to 4) were randomized 31 to treatment with the Ranger DCB or standard percutaneous transluminal angioplasty (PTA). Twelve-month primary target lesion patency, freedom from major adverse events (i.e., target lesion revascularization, major amputations, death within 1month of the index procedure), and patient outcomes were analyzed.
Mean lesion length was 82.5 ± 48.9mm for the Ranger DCB group (n=278) and 79.9 ± 49.3mm for the control group (n=98). Ranger DCB was superior to PTA (82.9% [n=194 of 234] vs. 66.3% [n=57 of 86]) with observed 12-month primary patency rates yielding a difference of 16.6% (95% confidence interval 5.5% to 27.7%; p=0.0013). Noninferior freedom from major adverse events (94.1% [n=241 of 256] vs. 83.5% [n=76 of 91]) was demonstrated with a difference of 10.6% (95% confidence interval 2.5% to 18.8%; noninferiority p<0.0001). Primary patency rate curves showed significant separation by Kaplan-Meier analysis (log-rank p=0.0005), with rates of 89.8% and 74.0% estimated at day 365 for the Ranger DCB and PTA cohorts, respectively.
The low-dose Ranger DCB demonstrated significantly better effectiveness than standard PTA through 1 year and a good safety profile. (Ranger™ Paclitaxel Coated Balloon vs Standard Balloon Angioplasty [RANGER II SFA]; NCT03064126).
The low-dose Ranger DCB demonstrated significantly better effectiveness than standard PTA through 1 year and a good safety profile. (Ranger™ Paclitaxel Coated Balloon vs Standard Balloon Angioplasty [RANGER II SFA]; NCT03064126).
The aim of this study was to investigate whether earlier extracorporeal membrane oxygenation (ECMO) support is associated with improved clinical outcomes in patients with refractory cardiogenic shock (CS).
The prognosis of patients with refractory CS receiving ECMO remains poor. However, little is known about the association between the timing of ECMO implantation and clinical outcomes in these patients.
From a multicenter registry, 362 patients with refractory CS who underwent ECMO between January 2014 and December 2018 were identified. Participants were classified into 3 groups according to tertiles of shock-to-ECMO time (early, intermediate, and late ECMO). Inverse probability of treatment weighting was conducted to adjust for baseline differences among the groups, followed by a weighted Cox proportional hazards regression analysis to calculate hazard ratios and 95% confidence intervals for 30-day mortality associated with each ECMO time group.
The overall 30-day mortality rate was 40.9%. The risk for 30-day mortality was lower in the early group than in the late group (hazard ratio 0.53; 95% confidence interval 0.28 to 0.99). Early ECMO support was also associated with lower risk for in-hospital mortality, ECMO weaning failure, composite of all-cause mortality or rehospitalization for heart failure at 1 year, all-cause mortality at 1 year, and poor neurological outcome at discharge. However, the incidence of adverse events, including stroke, limb ischemia, ECMO-site bleeding, and gastrointestinal bleeding, did not differ significantly among the groups.
Earlier ECMO support was associated with improved clinical outcomes in patients with refractory CS.
Earlier ECMO support was associated with improved clinical outcomes in patients with refractory CS.
This study sought to define the risk of stent thrombosis (ST) and myocardial infarction (MI) in cancer patients compared with noncancer patients after percutaneous coronary intervention (PCI).
Cancer patients are considered to be at high thrombotic risk, but data on whether this is the case after PCI remain inconclusive.
Cancer patients undergoing PCI at Mayo Clinic Rochester from January 1, 2003, to December 31, 2013, were identified by cross-linking institutional cancer and PCI databases and by propensity score matching to noncancer patients. The combined primary endpoint was all-cause mortality, MI, and revascularization rate at 5-year follow-up. Secondary endpoints were the individual primary endpoint components, cause of mortality, ST, and Bleeding Academic Research Consortium 2+ bleeding.
The primary endpoint occurred in 48.6% of 416 cancer and in 33.0% of 768 noncancer patients (p<0.001). In competing risk analyses, cancer patients had a higher rate of noncardiac death (24.0% vs. 10.5%; p<0.001) and a lower rate of cardiac death (5.0% vs. 11.7%; p<0.001). Cancer patients had a higher rate of MI (16.1% vs. 8.0%; p<0.001), ST (6.0% vs. 2.3%; p<0.001), repeat revascularization (21.2% vs. 10.0%; p<0.001), and bleeding (6.7% vs. 3.9%; p=0.03). The most critical period for ST in cancer patients was in the first year after PCI. The dual antiplatelet therapy score was predictive of thrombotic and ischemic events in both groups.
Cancer patients have a higher risk of thrombotic and ischemic events after PCI, identifiable by a high dual antiplatelet therapy score. These findings have important implications for antiplatelet therapy decisions.
Cancer patients have a higher risk of thrombotic and ischemic events after PCI, identifiable by a high dual antiplatelet therapy score. These findings have important implications for antiplatelet therapy decisions.
The primary objective of the current analysis was to assess the association between the clinical presentation at index procedure and mortality in patients with second-generation drug-eluting stent thrombosis (G2-ST).
Patients with acute coronary syndrome (ACS) have a higher risk for stent thrombosis (ST) as compared with those with chronic coronary syndrome (CCS). However, clinical outcomes of patients with G2-ST after treatment for ACS and CCS remain poorly understood.
From the REAL-ST (Retrospective Multicenter Registry of ST After First- and Second-Generation Drug-Eluting Stent Implantation) registry, this study evaluated 313 patients with G2-ST. According to baseline clinical presentation, patients were divided into the 2 groups the ACS and CCS groups (n=147 and n=166, respectively). The primary endpoint was the cumulative 3-year incidence of all-cause death after the index ST events. Timing of ST, target lesion revascularization, and recurrent ST were also assessed.
Early ST was more frequently observed in the ACS group (71.4% vs. 44.6%), while very late ST was less likely to occur in the ACS group than in the CCS group (11.6% vs. 30.7%). Cumulative 3-year incidence of all-cause death after the index ST events was comparable between the ACS and CCS groups (28.6% vs. 28.3%; hazard ratio 1.14; 95% confidence interval 0.75 to 1.73; p=0.55). TBOPP Compared with the CCS group, the ACS group showed higher incidences of target lesion revascularization and recurrent ST (23.8% vs. 17.2%; p=0.06; and 9.9% vs. 1.4%; p=0.001, respectively).
Patients with G2-ST were associated with higher mortality irrespective of baseline clinical presentation.
Patients with G2-ST were associated with higher mortality irrespective of baseline clinical presentation.
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