Claudication Pain Research Articles

Drug-Coated Balloon Treatment of Femoropopliteal Lesions for Patients With Intermittent Claudication and Ischemic Rest Pain: 2-Year Results From the IN.PACT Global Study

ObjectivesThe IN.PACT Global Study is the largest prospective, multicenter, independently adjudicated trial to evaluate a paclitaxel drug-coated balloon in patients with lifestyle-limiting claudication and/or ischemic rest pain due to atherosclerotic disease of the femoropopliteal artery and includes complex lesions beyond what are typically included in randomized controlled trials. BackgroundRandomized controlled trials have demonstrated the safety and efficacy of drug-coated balloons for the treatment of Trans-Atlantic Inter-Society Consensus Document II A and B lesions, but there is a need for large-scale prospective studies to evaluate a broader range of lesions. MethodsThe IN.PACT Global Study enrolled 1,535 subjects, and 1,406 (1,773 lesions) were included in the pre-defined clinical cohort analysis. Freedom from clinically driven target lesion revascularization was evaluated at 24 months. The safety composite endpoint was freedom from device- and procedure-related death through 30 days and freedom from target limb major amputation and clinically driven target vessel revascularization within 24 months. ResultsMean lesion length was 12.1 cm, 35.5% were total occlusions, and 18.0% had in-stent restenosis. Freedom from clinically driven target lesion revascularization at 24 months was 83.3%, the composite safety endpoint was met in 81.7%, the 2-year all-cause mortality rate was 7.0%, and the major target limb amputation rate was 0.7%. Increased lesion length and the presence of de novo in-stent restenosis or coronary artery disease were associated with increased risk for clinically driven target lesion revascularization by 24 months. ConclusionsThis real-world study of femoropopliteal artery disease treatment with drug-coated balloons confirmed positive findings reported from more strictly designed randomized controlled trials and showed that outcomes are durable in this population up to 2 years after treatment. (IN.PACT Global Clinical Study; NCT01609296)

Vasculogenic paraplegia and impotence : A rare presentation of Buerger’s disease

Abstract Buerger’s disease is a non-atherosclerotic segmental inflammatory disease involving the small and medium-sized arteries, veins and nerves leading to claudication and ischemic changes. Long standing disease can rarely involve abdominal aorta, iliac arteries leading to rest pain, paraplegia and impotence. It holds strong association with tobacco use. We present the case of a 30 year old male bidi smoker who presented with paraplegia and impotence for few days preceeded by claudication pain and numbness. Pulses were reduced and absent in all four limbs. Arterial Doppler revealed reduced and absent velocities in all four limbs. Computed tomographic angiography showed narrowing and occlusion of infrarenal abdominal, internal iliac arteries and distal vessel bed. Considering Buerger’s disease, patient was abstained from smoking, started on vasodilators, antiplatelet, statin and phosphodiesterase inhibitors. Surgical treatment was deferred. Abstinence from smoking definitely prevents disease progression. Prompt diagnosis and therapy can decrease chances of major amputations and disability.

Impaired Platelet Mitochondrial Bioenergetics Is Associated with Hemodynamic Dysfunction in Patient with Peripheral Arterial Occlusive Disease

Peripheral arterial occlusive disease (PAOD) is a clinical manifestation of systemic atherosclerosis. Circulating platelets can detect and respond to systemic metabolic and inflammatory stressors. The present study aimed to explore whether platelet mitochondrial bioenergetics are associated with the inflammatory indices and hemodynamic functions in patients with PAOD. Sixty‐four individuals diagnosed with PAOD were enrolled randomly in this study. Platelet mitochondrial O2 consumption rate (OCR) were measured using high‐resolution respirometry. The results demonstrated that PAOD patients with neutrophil‐to‐lymphocyte ratio (NLR)>3.0 and platelet‐to‐lymphocyte ratio (PLR)>150 revealed (i) lesser VO2peak and the distance to maximal claudication pain, (ii) lower ankle‐brachial pressure index and pulse wave velocity, and (iii) inferior the maximal and reserve OCR capacities in platelet mitochondria than those with NLR<3.0 and PLR<150. Therefore, hemodynamic dysfunction and exercise intolerance are associated with impaired platelet mitochondrial bioenergetics in inflammatory PAOD patients.This abstract is from the Experimental Biology 2018 Meeting. There is no full text article associated with this abstract published in The FASEB Journal.

Reversal of Lower-Extremity Intermittent Claudication and Rest Pain by Hydration

Medical treatment of disabling intermittent claudication or critical limb-threatening ischemia causing rest pain often fails or has partial response. In this pilot study, 36 patients (12 females) affected by disabling intermittent claudication or rest pain of the lower extremities were exposed to a daily 3-L water intake for up to 6 weeks. Cutaneous foot temperature, ankle/brachial index, time and distance of claudication, and pain intensity were recorded before and at the completion of the hydration period. Patients with a mean±SE age of 71±2years (range, 40-86) had disabling claudication (less than 100meters) for more than 5 months while 11% reported pain at rest. A 6-week water intake of more than 2,500mL/24hr was achieved in 35 of the 36 patients enrolled in the study. Increased water intake was associated with significant improvements in median ankle/brachial index (from 0.60 to 0.76; P < 0.0001) and skin temperature (first dorsal right toe, from 29.95°C to 30.0°C, P<0.001). Time and distance to report claudication of supervised treadmill exercise improved from 1.25 to 6.25min (P<0.0001) and from 100meters to 535meters (P<0.0001), respectively. This study suggests that hydration attained by daily water consumption of more than 2.5L has a robust impact on reducing the symptoms of disabling claudication and rest pain caused by peripheral vascular disease.

NeuroSpine Surgery Research Group (NSURG) Classification System for Grading Lumbar Synovial Cysts.

To classify facet joint cysts (FJC) which will assist in identification of patient groups to best fit with a particular intervention. Sagittal T2 -weighted magnetic resonance images (MRI) of these patients are used to measure cyst size, while axial T2 -weighted MRI are used to determine the percentage of the vertebral canal occupied by the cyst. The degree of spondylolisthesis is also measured through standing X-rays or sagittal MRI. The proposed grading system is as follows. Grade I includes cysts that occupy less than 25% of the canal diameter that usually present with unilateral radiculopathy. Grade II includes cysts that occupy less than 50% of the canal diameter and may present with radiculopathy, with or without claudicant symptoms. Grade III cysts may present with radiculopathy and claudication with bilateral leg symptoms, along with facetogenic pain symptoms. Grades IV and V include potential instability as defined by greater than 15% spondylolisthesis in addition to either less than or greater than 50% canal stenosis. With higher grade cysts, presentation may include: facetogenic back pain, radiculopathy and claudicant pain in variable degrees of severity. The optimal classification system grades FJC from I to V on the basis of canal compression and degree of spondylolisthesis. Prospective studies are required to confirm the validity of this grading scale for long-term use.

Takayasu’s Arteritis and Systemic Lupus Erythematosus-A Rare Coexistence

Takayasu arteritis, also known as “pulseless disease” is an inflammatory disease characterized by large caliber artery inflammation. Although tuberculosis and syphilis are known to be associated with Takayasu arteritis, it is rarely found in association with Systemic Lupus Erythematosus (SLE). We report a case of 28-year-old Indian female with SLE, on low dose corticosteroids, she presented with hypertension and developed sudden onset of abdominal pain. She was found to have features suggestive of large vessel vasculitis. The patient was treated with one month of high dose corticosteroids and discharged. She was reviewed, once inflammation subsided and underwent procedure of placement of a self-expandable stent. She had improvement of blood pressure immediate post procedure and reduction of abdominal pain and claudication pain after two weeks of follow up. Although, SLE is known to involve small and medium-sized arteries, large vessel involvement and features of Takayasu arteritis are extremely rare, clinically.

Minimally invasive surgery versus open surgery in the treatment of lumbar spondylolisthesis: study protocol of a multicentre, randomised controlled trial (MISOS trial)

IntroductionPatients with symptomatic spondylolisthesis are frequently treated with nerve root decompression, in addition to pedicle screw fixation and interbody fusion. Minimally invasive approaches are gaining attention in recent years, although...

Directional Atherectomy Followed by a Paclitaxel-Coated Balloon to Inhibit Restenosis and Maintain Vessel Patency: Twelve-Month Results of the DEFINITIVE AR Study.

Background—Studies assessing drug-coated balloons (DCB) for the treatment of femoropopliteal artery disease are encouraging. However, challenging lesions, such as severely calcified, remain difficult to treat with DCB alone. Vessel preparation with directional atherectomy (DA) potentially improves outcomes of DCB.Methods and Results—DEFINITIVE AR study (Directional Atherectomy Followed by a Paclitaxel-Coated Balloon to Inhibit Restenosis and Maintain Vessel Patency—A Pilot Study of Anti-Restenosis Treatment) was a multicenter randomized trial designed to estimate the effect of DA before DCB to facilitate the development of future end point-driven randomized studies. One hundred two patients with claudication or rest pain were randomly assigned 1:1 to DA+DCB (n=48) or DCB alone (n=54), and 19 additional patients with severely calcified lesions were treated with DA+DCB. Mean lesion length was 11.2±4.0 cm for DA+DCB and 9.7±4.1 cm for DCB (P=0.05). Predilation rate was 16.7% for DA+DCB versus 74.1% for DCB; postdilation rate was 6.3% for DA+DCB versus 33.3% for DCB. Technical success was superior for DA+DCB (89.6% versus 64.2%; P=0.004). Overall bail-out stenting rate was 3.7%, and rate of flow-limiting dissections was 19% for DCB and 2% for DA+DCB (P=0.01). One-year primary outcome of angiographic percent diameter stenosis was 33.6±17.7% for DA+DCB versus 36.4±17.6% for DCB (P=0.48), and clinically driven target lesion revascularization was 7.3% for DA+DCB and 8.0% for DCB (P=0.90). Duplex ultrasound patency was 84.6% for DA+DCB, 81.3% for DCB (P=0.78), and 68.8% for calcified lesions. Freedom from major adverse events at 1 year was 89.3% for DA+DCB and 90.0% for DCB (P=0.86).Conclusions—DA+DCB treatment was effective and safe, but the study was not powered to show significant differences between the 2 methods of revascularization in 1-year follow-up. An adequately powered randomized trial is warranted.Clinical Trial Registration—http://www.clinicaltrials.gov. Unique Identifier: NCT01366482.

Peripheral Artery Diseases

Peripheral arterial diseases (PADs) compromise blood flow to the limbs. Common causes of arterial obstruction include atherosclerosis, thrombus, embolism, vasculitis, arterial entrapment, adventitial cysts, fibromuscular dysplasia, arterial dissection, trauma, and vasospasm. The most frequently encountered cause of PAD is peripheral atherosclerosis. This chapter considers its epidemiology and risk factors, as well as its diagnosis, including clinical presentation and noninvasive diagnostic tests. This chapter also discusses acute arterial occlusion, atheroembolism, popliteal artery entrapment, thromboangiitis obliterans, and acrocyanosis, as well as the etiology, diagnosis, and treatment of Raynaud phenomenon. The chapter contains 4 tables and 7 figures. Tables describe the Fontaine classification and clinical categories of chronic limb ischemia, provide examples of leg segmental pressure measurements in a patient with calf claudication and foot pain, and summarize secondary causes of Raynaud phenomenon. Figures include a photograph of an ischemic foot demonstrating dependent rubor, measurement of the ankle:brachial index, ultrasonography of a stenosis of the right common femoral artery, magnetic resonance angiograms of patients with calf claudication, arteriograms of critical ischemia of the foot and of disabling claudication of the leg, and ischemia of the toes caused by atheroemboli. This chapter contains 80 references.

Peripheral Artery Diseases

Peripheral arterial diseases (PADs) compromise blood flow to the limbs. Common causes of arterial obstruction include atherosclerosis, thrombus, embolism, vasculitis, arterial entrapment, adventitial cysts, fibromuscular dysplasia, arterial dissection, trauma, and vasospasm. The most frequently encountered cause of PAD is peripheral atherosclerosis. This chapter considers its epidemiology and risk factors, as well as its diagnosis, including clinical presentation and noninvasive diagnostic tests. This chapter also discusses acute arterial occlusion, atheroembolism, popliteal artery entrapment, thromboangiitis obliterans, and acrocyanosis, as well as the etiology, diagnosis, and treatment of Raynaud phenomenon. The chapter contains 4 tables and 7 figures. Tables describe the Fontaine classification and clinical categories of chronic limb ischemia, provide examples of leg segmental pressure measurements in a patient with calf claudication and foot pain, and summarize secondary causes of Raynaud phenomenon. Figures include a photograph of an ischemic foot demonstrating dependent rubor, measurement of the ankle:brachial index, ultrasonography of a stenosis of the right common femoral artery, magnetic resonance angiograms of patients with calf claudication, arteriograms of critical ischemia of the foot and of disabling claudication of the leg, and ischemia of the toes caused by atheroemboli. This chapter contains 80 references.

Hip flexor muscle dysfunction during walking at self-selected and fast speed in patients with aortoiliac peripheral arterial disease

ObjectiveIntermittent claudication aggravates physical function and is associated with an increased risk of death in patients with peripheral arterial disease (PAD). Previous studies on kinetic parameters (joint moment and power) of lower limbs in these patients have largely focused on the decline in the ankle plantar flexor moment and power at self-selected (SS) walking speed, which may not be an optimal condition to induce claudication pain. In the present study, we investigated the abnormalities in joint kinetic parameters in patients with PAD at both SS and at fast walking speeds. MethodsWe recruited 16 patients with aortoiliac PAD (4 unilateral and 12 bilateral) and 10 healthy controls. The participants were instructed to walk at SS and fast speeds along a 7-meter walkway embedded with a force plate. Spatiotemporal parameters and joint kinetic parameters of the lower limbs during the stance phase were recorded using a three-dimensional motion analysis device. ResultsCompared with the controls, patients with PAD showed a significant reduction in their walking speed, step length, stride length, and cadence. Further, a reduction in peak hip flexor moment at fast walking speed and in peak hip flexor generation power was observed in both modes of walking. However, no significant between-group differences were observed for the peak ankle plantar flexor moment or power at either walking speed. Multiple regression analysis showed peak hip flexor generation power was a strong contributor to reduction at both SS and fast walking speeds in patients with PAD. ConclusionsPatients with aortoiliac PAD walk slowly and show reduced kinetic parameters of the hip joint at both SS and fast walking speeds. Our results suggest that hip flexor muscles may be a useful target for exercise training in patients with aortoiliac PAD.

Stand-alone Lateral Recess Decompression Without Discectomy in Patients Presenting With Claudicant Radicular Pain and MRI Evidence of Lumbar Disc Herniation: A Prospective Study.

A prospective study. The aim of this study was to analyze the outcomes of stand-alone lateral recess decompression without discectomy in patients with claudicant radicular pain and magnetic resonance imaging (MRI) showing LRS (lateral recess stenosis) with lumbar disc herniation. Discectomy is the gold standard treatment for symptomatic lumbar disc herniations refractory to conservative care. Typically, patients with positive SLR (Straight leg raising test) and flexion dominant leg pain are the ideal candidates who can be benefited from discectomy. There is a subset of patients with morphological features of lumbar disc herniation with LRS on MRI and presenting with diametrically opposite symptoms such as claudicant leg pain, extension dominant leg pain, relief on flexion, and a negative SLR. Until now, no focused prospective study in the literature highlights stand-alone lateral recess decompression in this group of patients. From January 2007 to June 2013, 55 patients having unilateral claudicant radicular pain were selected to undergo stand-alone lateral recess decompression with tubular retractors. Intraoperatively, disc consistency and presence of sequestrated fragments were analyzed. Visual Analogue Scale (VAS), Oswestry Disability Index (ODI) score, and Macnab criteria were used to measure outcomes. Out of 55 patients, stand-alone lateral recess decompression was successfully executed in 51 patients and remaining four patients had sequestrated discs that required removal. Mean age at presentation was 54.5 years (41-67 years), male:female ratio was 1.12:1, and mean follow-up was 3.8 years (3-5.8 years). Significant improvement (P < 0.0001) was noticed between preoperative and postoperative VAS score (8.39 ± 0.84 vs. 2.5 ± 0.48) and ODI score (46.79 ± 1.85 vs. 18.71 ± 2.41). As per Macnab criteria, 94% patients were satisfied with surgery. Stand-alone lateral recess decompression without discectomy is clinically effective for a large majority of patients with claudicant radicular pain and MRI evidence of LRS with associated lumbar disc herniation. The ability to perform it with minimal invasive techniques makes it focused and targeted with minimal morbidity. 4.

Muscle strength and control characteristics are altered by peripheral artery disease

ObjectivePeripheral artery disease (PAD), a common manifestation of atherosclerosis, is characterized by lower leg ischemia and myopathy in association with leg dysfunction. Patients with PAD have impaired gait from the first step they take with consistent defects in the movement around the ankle joint, especially in plantar flexion. Our goal was to develop muscle strength profiles to better understand the problems in motor control responsible for the walking impairment in patients with PAD. MethodsNinety-four claudicating PAD patients performed maximal isometric plantar flexion contractions lasting 10 seconds in two conditions: pain free (patient is well rested and has no claudication symptoms) and pain induced (patient has walked and has claudication symptoms). Sixteen matched healthy controls performed the pain-free condition only. Torque curves were analyzed for dependent variables of muscle strength and motor control. Independent t-tests were used to compare variables between groups, and dependent t-tests determined differences between conditions. ResultsPatients with PAD had significantly reduced peak torque and area under the curve compared with controls. Measures of control differed between PAD conditions only. Load rate and linear region duration were greater in the pain condition. Time to peak torque was shorter in the pain condition. ConclusionsThis study conclusively demonstrates that the plantar flexor muscles of the PAD patient at baseline and without pain are weaker in patients with PAD compared with controls. With the onset of claudication pain, patients with PAD exhibit altered muscle control strategies and further strength deficits are manifest compared to baseline levels. The myopathy of PAD legs appears to have a central role in the functional deterioration of the calf muscles, as it is evident both before and after onset of ischemic pain.

VH11 Open Surgical Treatment of Symptomatic Juxtarenal Aortic Occlusion

A 49-year-old man presented with a 6-week history of severe rest pain. Computed tomography angiography revealed an occluded infrarenal abdominal aorta to the level of the renal arteries. Both iliac arteries were occluded, and reconstituted femoral and distal arteries were under-perfused but patent. A decision was made to perform an aortobifemoral bypass. A suprarenal clamp was needed initially to clear out juxtarenal thrombus and plaque, then the clamp was subsequently moved to the infrarenal aorta. He was discharged home on postoperative day 5. At the 1-month follow-up he had no claudication or rest pain symptoms, well-healing incisions, and palpable pedal pulses. http://www.conferenceabstracts.com/uploads/cfp2/attachments/ZRFDQHCR/ZRFDQHCR--289531-1-ANY (2).mp4

Sagittal plane joint kinetics during stair ascent in patients with peripheral arterial disease and intermittent claudication

Stair negotiation poses a substantial physical demand on the musculoskeletal system and this challenging task can place individuals at risk of falls. Peripheral arterial disease (PAD) can cause intermittent claudication (IC) pain in the calf and results in altered gait mechanics during level walking. However, whether those with PAD-IC adopt alternate strategies to climb stairs is unknown. Twelve participants with PAD-IC (six bilateral and six unilateral) and 10 healthy controls were recruited and instructed to ascend a five-step staircase whilst 3D kinematic data of the lower-limbs were recorded synchronously with kinetic data from force plates embedded into the staircase on steps two and three. Limbs from the unilateral group and both limbs from the bilateral claudicants were categorised as claudicating (N=18), asymptomatic (N=6) and control (N=10). Claudicants walked more slowly than healthy controls (trend; P=<0.066). Both claudicating- and asymptomatic-limb groups had reduced propulsive GRF (P=0.025 and P=0.002, respectively) and vertical GRF (P=0.005 and P=0.001, respectively) compared to controls. The claudicating-limb group had a reduced knee extensor moment during forward continuance (P=0.060), ankle angular velocity at peak moment (P=0.039) and ankle power generation (P=0.055) compared to the controls. The slower gait speed, irrespective of laterality of symptoms, indicates functional capacity was determined by the limitations of the claudicating limb. Reduced ankle power generation and angular velocity (despite adequate plantarflexor moment) implies velocity-dependent limitations existed in the calf. The lack of notable compensatory strategies indicates reliance on an impaired muscle group to accomplish this potentially hazardous task, highlighting the importance of maintaining plantarflexor strength and power in those with PAD-IC.

Anomalous origin of posterior tibial artery from anterior tibial artery: beware!

A 64 year old diabetic, hypertensive male with claudication and rest pain in his left leg was found to have diffuse narrowing below the politeal artery in the left lower limb with good collaterals. There was bifurcation of the right popliteal artery above the knee joint and an anomalous origin of the right posterior tibial artery from the anterior tibial artery. Awareness of anotomical variations is important for evaluation of the lower extremity arteriograms, for vascular surgeons during reconstructions such as femorodistal bypass graft procedures and embolectomy, during surgical techniques such as arthroscopy, tibial osteotomy, vascular reconstruction grafts, plastic surgical flaps and catheterization procedures.

Impact of Implantation Defects on Intermediate Outcome of Supera Stent for Popliteal Artery Stenosis

This study reports our experience during the first 50 cases of use of Supera stent for popliteal atherosclerotic lesions treatment. This prospective single-arm trial enrolled the first 50 limbs (46 patients) treated in our center with a Supera stent for symptomatic atherosclerotic disease of the popliteal artery and a follow-up longer than 12months. Tissue loss (43.5%) was the most common primary indication for intervention, followed by claudication (37.0%) and rest pain (19.5%). Stent implantation was successful in all patients. The majority of lesions were Trans-Atlantic Inter-Society Consensus (TASC) II type D lesions (64%). The lesions treated were localized in P3 zone in 64%, P2 zone in 28%, and P1 zone in 8%. One runoff vessel was the most common situation (42%). Mean follow-up was 16.5months (range 12-46). The mean preoperative ankle-brachial index increased from 0.38+0.37 before intervention to 0.63+0.86 postoperatively at 12 months (P=0.014). Primary patency rates at 3, 6, 9, and 12months were 95.9%, 91.7%, 89.6%, and 89.6%, and primary assisted patency rates were 95.9%, 93.8%, 93.8%, and 93.8%, respectively. In-stent restenosis was associated with the following: patient <75years (P=0.023), female sex (P=0.032), and TASC-II D lesions (P=0.041). Implantation defects did not constitute a risk factor for stent restenosis. The implantation of the interwoven nitinol stents in patients with popliteal occlusive disease is safe and effective, with encouraging patency rates and clinical results after a 12-month follow-up. In our experience, we have not seen significant differences in patency at 1-year follow-up in patients with implantation defects.

Patients With Intermittent Claudication and Chronic Widespread Pain Improves in Health-Related Quality of Life After Invasive but Not After Noninvasive Treatment.

Background:Intermittent claudication (IC) is traditionally managed with risk factor modification, best medical treatment (BMT), and exercise training. Comorbidities such as diabetes and ischemic heart disease affect both results of invasive treatment and health-related quality of life (HRQoL) negatively. It is unknown how chronic widespread pain (CWP) influences the results of invasive treatment. We evaluated the influence of CWP on HRQoL in patients undergoing invasive (open surgery or endovascular treatment) and noninvasive BMT of IC.Methods:A total of 242 patients with IC treated with invasive or noninvasive methods responded to the validated HRQoL questionnaires Short Form 36 Health Survey, EuroQoL 5-dimensions, and distribution of pain with the Epipain questionnaire at baseline and after 12 months.Results:Invasively treated patients without CWP improved in all primary outcome measures. Patients with CWP reported significant improvements in most of the HRQoL-related outcome measures after invasive treatment, but patients with CWP in the noninvasive treatment group did not improve in any HRQoL-related outcome measure.Conclusions:The presence of CWP not should be a cause to withhold invasive treatment in patients with IC.

Evaluation of Effect of Posterior Dynamic Stabilization IntraSPIN System on Sagittal Spinal Balance using EOS® X-Ray Imaging System

Aim of this prospective study is to assess the effect of posterior dynamic stabilization IntraSPINE system on sagittal spinal balance, using EOS® X-Ray imaging system. Between March and December 2015, 8 patients affected by lumbar soft stenosis underwent indirect decompression of the lumbar canal by positioning of IntraSPINE® device. Sagittal balance was evaluated considering following parameters: C7 Plum Line (C7PL), Thoracic Kyphosis (TK), Lumbar Lordosis (LL), Pelvic Tilt (PT), Pelvic Index (PI) and Sacral Slope (SS). The EOS® 2D/3D system and corresponding sterEOS 3D software for surface 3D reconstruction has been used to calculate the above mentioned parameters. All patients had neurogenic claudication and low back pain for more than 6 months and resistant to drug treatment. They underwent clinical examination before surgery and 1 month after surgery. Statistical analyses were performed using Stata software. All results were considered significant if p<0.05. C7PL, TK, LL, PI and SS were not modified after surgery. PT increased after surgery. VAS, ODI and JOA significantly increased after surgery. The results show that the posterior dynamic stabilization offered by this device leads to a good symptoms control and does not seems to change the sagittal balance.

Safety and Effectiveness of Bone Marrow Cell Concentrate in the Treatment of Chronic Critical Limb Ischemia Utilizing a Rapid Point-of-Care System.

Critical limb ischemia (CLI) is the end stage of lower extremity peripheral vascular disease (PVD) in which severe obstruction of blood flow results in ischemic rest pain, ulcers and/or gangrene, and a significant risk of limb loss. This open-label, single-arm feasibility study evaluated the safety and therapeutic effectiveness of autologous bone marrow cell (aBMC) concentrate in revascularization of CLI patients utilizing a rapid point-of-care device. Seventeen (17) no-option CLI patients with ischemic rest pain were enrolled in the study. Single dose of aBMC, prepared utilizing an intraoperative point-of-care device, the Res-Q™ 60 BMC system, was injected intramuscularly into the afflicted limb and patients were followed up at regular intervals for 12 months. A statistically significant improvement in Ankle Brachial Index (ABI), Transcutaneous Oxygen Pressure (TcPO2), mean rest pain and intermittent claudication pain scores, wound/ ulcer healing, and 6-minute walking distance was observed following aBMC treatment. Major amputation-free survival (mAFS) rate and amputation-free rates (AFR) at 12 months were 70.6% and 82.3%, respectively. In conclusion, aBMC injections were well tolerated with improved tissue perfusion, confirming the safety, feasibility, and preliminary effectiveness of aBMC treatment in CLI patients.