Evidence of heat sensitivity in people with Parkinson's disease.

Examining how heat affects people with Parkinson's disease is essential for informing clinical decision-making, safety, well-being, and healthcare planning. While there is evidence that the neuropathology associated with Parkinson's disease affects thermoregulatory mechanisms, little attention has been given to the association of heat sensitivity to worsening symptoms and restricted daily activities in people with this progressive disease. Using a cross-sectional study design, we examined the experiences of people diagnosed with Parkinson's disease in the heat. Two-hundred and forty-seven people completed an online survey (age: 66.0 ± 9.2 years; sex: male = 102 (41.3%), female = 145 (58.7%)), of which 195 (78.9%) reported becoming more sensitive to heat with Parkinson's disease. Motor and nonmotor symptoms worsened with heat in 182 (73.7%) and 203 (82.2%) respondents, respectively. The most commonly reported symptoms to worsen included walking difficulties, balance impairment, stiffness, tremor, fatigue, sleep disturbances, excess sweating, difficulty concentrating, and light-headedness when standing. Concerningly, over half indicated an inability to work effectively in the heat, and nearly half reported that heat impacted their ability to perform household tasks and social activities. Overall, heat sensitivity was common in people with Parkinson's disease and had a significant impact on symptomology, day-to-day activities and quality of life.

Movement smoothness during a functional mobility task in subjects with Parkinson's disease and freezing of gait - an analysis using inertial measurement units.

BACKGROUND: Impairments of functional mobility may affect locomotion and quality of life in subjects with Parkinson's disease (PD). Movement smoothness measurements, such as the spectral arc length (SPARC), are novel approaches to quantify movement quality. Previous studies analyzed SPARC in simple walking conditions. However, SPARC outcomes during functional mobility tasks in subjects with PD and freezing of gait (FOG) were never investigated. This study aimed to analyze SPARC during the Timed Up and Go (TUG) test in individuals with PD and FOG. METHODS: Thirty-one participants with PD and FOG and six healthy controls were included. SPARC during TUG test was calculated for linear and angular accelerations using an inertial measurement unit system. SPARC data were correlated with clinical parameters: motor section of the Unified Parkinson's Disease Rating Scale, Hoehn & Yahr scale, Freezing of Gait Questionnaire, and TUG test. RESULTS: We reported lower SPARC values (reduced smoothness) during the entire TUG test, turn and stand to sit in subjects with PD and FOG, compared to healthy controls. Unlike healthy controls, individuals with PD and FOG displayed a broad spectral range that encompassed several dominant frequencies. SPARC metrics also correlated with all the above-mentioned clinical parameters. CONCLUSION: SPARC values provide valid and relevant clinical data about movement quality (e.g., smoothness) of subjects with PD and FOG during a functional mobility test.

Can We Rely on Mobile Devices and Other Gadgets to Assess the Postural Balance of Healthy Individuals? A Systematic Review.

The consequences of falls, costs, and complexity of conventional evaluation protocols have motivated researchers to develop more effective balance assessments tools. Healthcare practitioners are incorporating the use of mobile phones and other gadgets (smartphones and tablets) to enhance accessibility in balance evaluations with reasonable sensitivity and good cost-benefit. The prospects are evident, as well as the need to identify weakness and highlight the strengths of the different approaches. In order to verify if mobile devices and other gadgets are able to assess balance, four electronic databases were searched from their inception to February 2019. Studies reporting the use of inertial sensors on mobile and other gadgets to assess balance in healthy adults, compared to other evaluation methods were included. The quality of the nine studies selected was assessed and the current protocols often used were summarized. Most studies did not provide enough information about their assessment protocols, limiting the reproducibility and the reliability of the results. Data gathered from the studies did not allow us to conclude if mobile devices and other gadgets have discriminatory power (accuracy) to assess postural balance. Although the approach is promising, the overall quality of the available studies is low to moderate.

Biomechanical and functional indicators in male semiprofessional soccer players with increased hip alpha angles vs. amateur soccer players.

BACKGROUND: Femoroacetabular impingement (FAI) is predominant in young male athletes, but not much is known about gait differences in cases of increased hip alpha angles. In our study, the hip alpha angle of Nötzli of soccer players was quantified on the basis of magnetic resonance imaging (MRI) with axial oblique sequences. The aim of the current study was to compare the rearfoot motion and plantar pressure in male semiprofessional soccer players with increased alpha angles to age-matched amateur soccer players. METHODS: In a prospective analysis, male semiprofessional and amateur soccer players had an MRI of the right hip to measure the alpha angle of Nötzli. In a biomechanical laboratory setting, 14 of these participants in each group ran in two shoe conditions. Simultaneously in-shoe pressure distribution, tibial acceleration, and rearfoot motion measurements of the right foot were performed. RESULTS: In the semiprofessional soccer group, the mean value of the alpha angle of group was 55.1 ± 6.58° (range 43.2-76.6°) and 51.6 ± 4.43° (range 41.9-58.8°) in the amateur group. In both shoe conditions, we found a significant difference between the two groups concerning the ground reaction forces, tibial acceleration, rearfoot motion and plantar pressure parameters (P < 0.01, P < 0.05, P = 0.04). Maximum rearfoot motion is about 22% lower in the semiprofessional group compared to the amateur group in both shoe conditions. CONCLUSIONS: This study confirmed that semiprofessional soccer players with increased alpha angles showed differences in gait kinematics compared to the amateur group. These findings support the need for a screening program for competitive soccer players. In cases of a conspicuous gait analysis and symptomatic hip pain, FAI must be ruled out by further diagnostic tests.

Biventricular circulatory support with two miniaturized implantable assist devices.

BACKGROUND: Up to 30% of patients with end-stage heart failure experience biventricular failure that requires biventricular mechanical support. For these patients, only bulky extracorporeal or implantable displacement pumps or the total artificial heart have been available to date, which enables only limited quality of life for the patients. It was our goal to evaluate a method that would allow the use of 2 implantable centrifugal left ventricular assist devices as a biventricular assist system. METHODS AND RESULTS: Seventeen patients have been implanted with 2 HeartWare HVAD pumps, 1 as a left ventricular assist device and 1 as a right ventricular assist device. Seventy-seven percent of the patients had idiopathic dilated or ischemic cardiomyopathy. Their age ranged from 29 to 73 years (mean 51.8 ± 14.5 years), and 11 (64.7%) received intravenous catecholamine support preoperatively. The right ventricular assist device pump was implanted into the right ventricular free wall. The afterload of this pump was artificially increased by local reduction of the outflow graft diameter, and the effective length of its inflow cannula was reduced by the addition of two 5-mm silicon suture rings to the original HVAD implantation ring. All right ventricular assist device devices could be operated in appropriate speed ranges and delivered a flow of between 3.0 and 5.5 L/min. Thirty-day survival was 82%, and 59% of the patients could be discharged home after recovering from the operation. There was no clinically relevant hemolysis in any of the patients. CONCLUSIONS: Two HeartWare HVAD pumps can be used as a biventricular assist system. This implantable biventricular support gives the patients more comfort and mobility than usual biventricular ventricular assist devices with large and noisy displacement pumps.

The influence of soccer shoe design on player performance and injuries.

Although soccer is the most popular sport in the world, little research has been published in the field of soccer biomechanics, particularly on the importance of footwear for the game. The traction properties of soccer shoes on natural and artificial turf have been speculated to be responsible for acute and chronic injuries in soccer. This article reviewed the current knowledge on how soccer shoes influence the risk of injuries and how they may serve to improve player performance. Comfort is the highest priority that players want from their shoes, followed by traction and stability. Cleat design and arrangement are important shoe features that allow for fast accelerations and stops, rapid cuts, and turns. Soccer shoe design can influence shooting speed and, even more important for the game of soccer, kicking accuracy. To combine shoe characteristics for injury prevention and better performance will be a challenge for future research on optimizing soccer shoes.

A comparison of lower limb EMG and ground reaction forces between barefoot and shod gait in participants with diabetic neuropathic and healthy controls.

BACKGROUND: It is known that when barefoot, gait biomechanics of diabetic neuropathic patients differ from non-diabetic individuals. However, it is still unknown whether these biomechanical changes are also present during shod gait which is clinically advised for these patients. This study investigated the effect of the participants own shoes on gait biomechanics in diabetic neuropathic individuals compared to barefoot gait patterns and healthy controls. METHODS: Ground reaction forces and lower limb EMG activities were analyzed in 21 non-diabetic adults (50.9 +/- 7.3 yr, 24.3 +/- 2.6 kg/m2) and 24 diabetic neuropathic participants (55.2 +/- 7.9 yr, 27.0 +/- 4.4 kg/m2). EMG patterns of vastus lateralis, lateral gastrocnemius and tibialis anterior, along with the vertical and antero-posterior ground reaction forces were studied during shod and barefoot gait. RESULTS: Regardless of the disease, walking with shoes promoted an increase in the first peak vertical force and the peak horizontal propulsive force. Diabetic individuals had a delay in the lateral gastrocnemius EMG activity with no delay in the vastus lateralis. They also demonstrated a higher peak horizontal braking force walking with shoes compared to barefoot. Diabetic participants also had a smaller second peak vertical force in shod gait and a delay in the vastus lateralis EMG activity in barefoot gait compared to controls. CONCLUSIONS: The change in plantar sensory information that occurs when wearing shoes revealed a different motor strategy in diabetic individuals. Walking with shoes did not attenuate vertical forces in either group. Though changes in motor strategy were apparent, the biomechanical did not support the argument that the use of shoes contributes to altered motor responses during gait.

Effects of different shoe-lacing patterns on dorsal pressure distribution during running and perceived comfort.

The purpose of this study was to investigate the effects of four lacing patterns (one regular, one tight, and two seven-eyelet lacings) on dorsal foot pressures during running and the perception of comfort and stability with 14 male rearfoot runners. By using a pressure insole, peak dorsal pressures were measured under the shoe's tongue. Highest peak pressures were found above the talus, the navicular bone, and the first ray. Seven-eyelet lacings showed a significant enhancement of perceived stability without differences in perceived comfort compared with a regular six-eyelet technique. Reduction of pressure on the talus, the navicular bone, and the extensor tendons is related to better comfort. With individually chosen special seven-eyelet lacings runners can improve foot-shoe coupling without increasing peak dorsal pressures on the tarsus. Knowledge of the location of the dorsal pressure distribution is useful for new tongue and lacing constructions to improve comfort in running shoes while maintaining stability.

Dual-task walking reduces lower limb range of motion in individuals with Parkinson's disease and freezing of gait: But does it happen during what events through the gait cycle?

BACKGROUND: It is unclear how dual-task gait influences the lower limb range of motion (RoM) in people with Parkinson's disease (PD) and freezing of gait (FOG). The lower limb kinematics during dual-task gait might differ from regular gait, but during what events in the gait cycle? METHODS: This is an observational within-subjects study. Thirty-two individuals with PD and FOG underwent a gait analysis. Single and dual-task gait was assessed by a 3D motion analysis system and the RoM data of the lower limb were extracted from hips, knees and ankles in the sagittal plane. Dual-task assignment was performed using word-color interference test. To compare both gait conditions, we used two different analyses: (1) common discrete analysis to provide lower limb RoM and (2) Statistical Parametric Mapping analysis (SPM) to provide lower limb joint kinematics. A correlation between lower limb RoM and spatiotemporal gait parameters was also performed for each gait condition. RESULTS: Common discrete analysis evidenced reductions in RoM of hips, knees and ankles during the dual task gait when compared to single gait. SPM analysis showed reductions in flexion-extension of hip, knees and ankles joints when dual task was compared to single task gait. These reductions were observed in specific gait events as toe off (for knees and ankles) and heel strike (for all joints). The reduction in lower limb RoM was positively correlated with the reduction in step length and gait speed. CONCLUSIONS: Lower limb joints kinematics were reduced during toe off and heel strike in dual task gait when compared to single gait. These findings might help physiotherapists to understand the influence of dual and single walking in lower limb RoM throughout the gait cycle in people with PD and FOG.

Sensitivity mapping of the human foot: thresholds at 30 skin locations.

BACKGROUND: Mechanoreceptors in the skin provide sensory input for the central nervous system about foot placement and loading. This information is used by the brain to actively control or regain balance and is important to establish memory traces for subsequent movement. A sensitivity map of the human foot could help to understand the mechanisms of the foot as a sensory organ for movement adjustment and balance control. MATERIALS AND METHODS: Touch and vibration perception threshold values from 30 plantar and dorsal foot locations were determined in more than 40 women and men between 20 and 35 years. Semmes Weinstein monofilaments and a vibrotactile neurothesiometer were used for skin sensitivity threshold detection. RESULTS: Large sensitivity differences were present between the 30 different foot sites. Gender effects were not present for touch but women had better sensitivities for vibration (p < 0.01), especially on the dorsal aspect of the foot. Age, in our cohort of 20- to 35-year-olds, did not have an influence on vibration or touch sensitivity. The heel had the highest detection thresholds for touch but was very sensitive for vibration stimuli. Compared to the dorsum, the plantar foot was substantially more sensitive, especially for vibration detection. CONCLUSION: The results suggest that primarily the fast adapting plantar mechanoreceptors are important in assisting balance control during human locomotion. CLINICAL RELEVANCE: The sensitivity map of the foot will help in understanding the function of the foot as a sensory organ and could be useful in creating footwear for better balance control and for the design of comfortable shoes.

Plantar pressures during shod gait in diabetic neuropathic patients with and without a history of plantar ulceration.

BACKGROUND: Diabetic neuropathy leads to progressive loss of sensation, lower-limb distal muscle atrophy, autonomic impairment, and gait alterations that overload feet. This overload has been associated with plantar ulcers even with consistent daily use of shoes. We sought to investigate and compare the influence of diabetic neuropathy and plantar ulcers in the clinical history of diabetic neuropathic patients on plantar sensitivity, symptoms, and plantar pressure distribution during gait while patients wore their everyday shoes. METHODS: Patients were categorized into three groups: a control group (CG; n=15), diabetic patients with a history of neuropathic ulceration (DUG; n=8), and diabetic patients without a history of ulceration (DG; n=10). Plantar pressure variables were measured by Pedar System shoe insoles in five plantar regions during gait while patients wore their own shoes. RESULTS: No statistical difference between neuropathic patients with and without a history of plantar ulcers was found in relation to symptoms, tactile sensitivity, and duration of diabetes. Diabetic patients without ulceration presented the lowest pressure-time integral under the heel (72.1+/-16.1 kPa x sec; P=.0456). Diabetic patients with a history of ulceration presented a higher pressure-time integral at the midfoot compared to patients in the control group (59.6+/-23.6 kPaxsecx45.8+/-10.4 kPaxsec; P=.099), and at the lateral forefoot compared to diabetic patients without ulceration (70.9+/-17.7 kPa secx113.2+/-61.1 kPaxsec, P=.0193). Diabetic patients with ulceration also presented the lowest weight load under the hallux (0.06+/-0.02%, P=.0042). CONCLUSIONS: Although presenting a larger midfoot area, diabetic neuropathic patients presented greater pressure-time integrals and relative loads over this region. Diabetic patients with ulceration presented an altered dynamic plantar pressure pattern characterized by overload even when wearing daily shoes. Overload associated with a clinical history of plantar ulcers indicates future appearance of plantar ulcers.

The effect of diabetic neuropathy and previous foot ulceration in EMG and ground reaction forces during gait.

BACKGROUND: We aimed at investigating the influence of diabetic neuropathy and previous history of plantar ulcers on electromyography (EMG) of the thigh and calf and on vertical ground reaction forces during gait. METHODS: This study involved 45 adults divided into three groups: a control group (n=16), diabetic neuropathic group (n=19) and diabetic neuropathic group with previous history of plantar ulceration (n=10). EMG of the right vastus lateralis, lateral gastrocnemius and tibialis anterior were studied during the stance phase. The peaks and time of peak occurrence were determined and a co-activation index between tibialis anterior and lateral gastrocnemius. In order to represent the effect of the changes in EMG, the first and second peaks and the minimum value of the vertical ground reaction force were also determined. Inter-group comparisons of the electromyographical and ground reaction forces variables were made using three MANCOVA (peaks and times of EMG and peaks of force) and one ANCOVA (co-activation index). FINDINGS: The ulcerated group presented a delayed in the time of the lateral gastrocnemius and vastus lateralis peak occurrence in comparison to control's. The lateral gastrocnemius delay may be related to the lower second vertical peak in diabetic subjects. However, the delay of the vastus lateralis did not cause any significant change on the first vertical peak. INTERPRETATIONS: The vastus lateralis and lateral gastrocnemius delay demonstrate that ulcerated diabetic neuropathic patients have a motor deficit that could compromise their ability to walk, which was partially confirmed by changes on ground reaction forces during the push-off phase.

A Lactate Kinetics Method for Assessing the Maximal Lactate Steady State Workload.

During a continuously increasing exercise workload (WL) a point will be reached at which arterial lactate accumulates rapidly. This so-called lactate threshold (LT) is associated with the maximal lactate steady state workload (MLSSW), the highest WL, at which arterial lactate concentration [LA] does not change. However, the physiological range in which the LT and the MLSSW occur has not been demonstrated directly. We used minor WL variations in the MLSSW range to assess arterial lactate kinetics in 278 treadmill and 148 bicycle ergometer exercise tests. At a certain workload, minimal further increment of running speed (0.1-0.15 m/s) or cycling power (7-10 W) caused a steep elevation of [LA] (0.9 ± 0.43 mM, maximum increase 2.4 mM), indicating LT achievement. This sharp [LA] increase was more pronounced when higher WL increments were used (0.1 vs. 0.30 m/s, P = 0.02; 0.15 vs. 0.30 m/s, P < 0.001; 7 vs. 15 W, P = 0.002; 10 vs. 15 W, P = 0.001). A subsequent workload reduction (0.1 m/s/7 W) stopped the [LA] increase indicating MLSSW realization. LT based determination of running speed (MLSSW) was highly reproducible on a day-to-day basis (r = 0.996, P < 0.001), valid in a 10 km constant velocity setting (r = 0.981, P < 0.001) and a half marathon race (r = 0.969, P < 0.001). These results demonstrate a fine-tuned regulation of exercise-related lactate metabolism, which can be reliably captured by assessing lactate kinetics at the MLSSW.

The pathomechanics of plantar fasciitis.

Plantar fasciitis is a musculoskeletal disorder primarily affecting the fascial enthesis. Although poorly understood, the development of plantar fasciitis is thought to have a mechanical origin. In particular, pes planus foot types and lower-limb biomechanics that result in a lowered medial longitudinal arch are thought to create excessive tensile strain within the fascia, producing microscopic tears and chronic inflammation. However, contrary to clinical doctrine, histological evidence does not support this concept, with inflammation rarely observed in chronic plantar fasciitis. Similarly, scientific support for the role of arch mechanics in the development of plantar fasciitis is equivocal, despite an abundance of anecdotal evidence indicating a causal link between arch function and heel pain. This may, in part, reflect the difficulty in measuring arch mechanics in vivo. However, it may also indicate that tensile failure is not a predominant feature in the pathomechanics of plantar fasciitis. Alternative mechanisms including 'stress-shielding', vascular and metabolic disturbances, the formation of free radicals, hyperthermia and genetic factors have also been linked to degenerative change in connective tissues. Further research is needed to ascertain the importance of such factors in the development of plantar fasciitis.

Mechanical cardiac support in the young with the Berlin Heart EXCOR pulsatile ventricular assist device: 15 years' experience.

The pediatric-size pneumatically driven pulsatile extracorporeal ventricular assist device (VAD) Berlin Heart EXCOR (Berlin Heart Mediprodukt GmbH, Berlin, Germany) was introduced into clinical practice by the German Heart Institute Berlin in 1992. Until July 1, 2005, Berlin Heart EXCOR systems have been used for circulatory support in 68 children up to 18 years of age with severe circulatory failure resistant to pharmacologic therapy. These were patients suffering from cardiomyopathy, fulminant myocarditis, end-stage congenital cardiac defects, and acute heart failure following congenital heart surgery. Mean VAD support time was 35 days (range, 0 to 420 days). Forty-two patients (62%) survived to transplantation or after weaning; 37 patients (54%), including eight infants, were discharged home. These results in patients with very advanced disease have improved significantly in recent years because of technical developments and growing experience in the treatment of patients on the device, in postoperative care and optimal timing for VAD implantation. Timely implantation of the Berlin Heart EXCOR in the course of progressive heart failure now appears to be justified because the system has undergone the necessary modifications and the accumulation of clinical knowledge has made its use highly reliable and safe.

A two-stage rotary blood pump design with potentially lower blood trauma: a computational study.

AIM: In current rotary blood pumps, complications related to blood trauma due to shear stresses are still frequently observed clinically. Reducing the rotor tip speed might decrease blood trauma. Therefore, the aim of this project was to design a two-stage rotary blood pump leading to lower shear stresses. METHODS: Using the principles of centrifugal pumps, two diagonal rotor stages were designed with an outer diameter of 22 mm. The first stage begins with a flow straightener and terminates with a diffusor, while a volute casing behind the second stage is utilized to guide fluid to the outlet. Both stages are combined into one rotating part which is pivoted by cup-socket ruby bearings. Details of the flow field were analyzed employing computational fluid dynamics (CFD). A functional model of the pump was fabricated and the pressure-flow dependency was experimentally assessed. RESULTS: Measured pressure-flow performance of the developed pump indicated its ability to generate adequate pressure heads and flows with characteristic curves similar to centrifugal pumps. According to the CFD results, a pressure of 70 mmHg was produced at a flow rate of 5 L/min and a rotational speed of 3200 rpm. Circumferential velocities could be reduced to 3.7 m/s as compared to 6.2 m/s in a clinically used axial rotary blood pump. Flow fields were smooth with well-distributed pressure fields and comparatively few recirculation or vortices. Substantially smaller volumes were exposed to high shear stresses >150 Pa. CONCLUSIONS: Hence, blood trauma might be reduced with this design. Based on these encouraging results, future in vitro investigations to investigate actual blood damage are intended.

A whole body vibration perception map and associated acceleration loads at the lower leg, hip and head.

Whole-body vibration (WBV) training has become popular in recent years. However, WBV may be harmful to the human body. The goal of this study was to determine the acceleration magnitudes at different body segments for different frequencies of WBV. Additionally, vibration sensation ratings by subjects served to create perception vibration magnitude and discomfort maps of the human body. In the first of two experiments, 65 young adults mean (± SD) age range of 23 (± 3.0) years, participated in WBV severity perception ratings, based on a Borg scale. Measurements were performed at 12 different frequencies, two intensities (3 and 5 mm amplitudes) of rotational mode WBV. On a separate day, a second experiment (n = 40) included vertical accelerometry of the head, hip and lower leg with the same WBV settings. The highest lower limb vibration magnitude perception based on the Borg scale was extremely intense for the frequencies between 21 and 25 Hz; somewhat hard for the trunk region (11-25 Hz) and fairly light for the head (13-25 Hz). The highest vertical accelerations were found at a frequency of 23 Hz at the tibia, 9 Hz at the hip and 13 Hz at the head. At 5 mm amplitude, 61.5% of the subjects reported discomfort in the foot region (21-25 Hz), 46.2% for the lower back (17, 19 and 21 Hz) and 23% for the abdominal region (9-13 Hz). The range of 3-7 Hz represents the safest frequency range with magnitudes less than 1 g(*)sec for all studied regions.

Shank Muscle Strength Training Changes Foot Behaviour during a Sudden Ankle Supination.

BACKGROUND: The peroneal muscles are the most effective lateral stabilisers whose tension braces the ankle joint complex against excessive supination. The purpose of this study was to identify the morphological and biomechanical effects of two machine-based shank muscle training methods. METHODS: Twenty-two healthy male recreationally active sports students performed ten weeks of single-set high resistance strength training with 3 training sessions per week. The subjects conducted subtalar pronator/supinator muscle training (ST) with the right leg by using a custom-made apparatus; the left foot muscles were exercised with machine-based talocrural plantar and dorsiflexor training (TT). Muscle strength (MVIC), muscle volume and foot biomechanics (rearfoot motion, ground reaction forces, muscle reaction times) during a sudden ankle supination were recorded before and after the intervention. RESULTS: Compared to TT, ST resulted in significantly higher pronator (14% vs. 8%, P<0.01) and supinator MVIC (25% vs. 12%, P<0.01). During sudden foot inversions, both ST and TT resulted in reduced supination velocity (-12%; P<0.01). The muscle reaction onset time was faster after the training in peroneus longus (PL) (P<0.01). Muscle volume of PL (P<0.01) and TA (P<0.01) increased significantly after both ST and TT. CONCLUSION: After both ST and TT, the ankle joint complex is mechanically more stabilised against sudden supinations due to the muscle volume increase of PL and TA. As the reduced supination velocities indicate, the strength training effects are already present during free-fall. According to a sudden ankle supination in standing position, both machine-based dorsiflexor and pronator strength training is recommended for enhancing the mechanical stability of the ankle.

Design changes in continuous-flow left ventricular assist devices and life-threatening pump malfunctions.

OBJECTIVES: The implantable continuous-flow left ventricular assist devices (LVADs) HeartMate II (HM II) and HeartWare HVAD (HW) underwent design modifications. The impact of these changes on life-threatening pump malfunctions was evaluated. METHODS: We retrospectively analysed pump malfunctions due to thrombosis or cable damage in patients supported with primarily implanted HM II (n = 191) and HW (n = 347), separated into patients supported with the old and new pump designs. In 2010, the cable strain relief of the HM II device was improved (132 patients with old and 79 with new) and sealed grafts were introduced (68 patients with sealed inflow connector and outflow graft and 125 without). In 2011, titanium sintering of the inflow cannula of HW pumps was introduced (137 patients with a non-sintered and 210 with a sintered inflow cannula). RESULTS: The median support time was 1.12 (0-6.1) years for all HM II and 0.59 (0-4.2) years for all HW patients. The cumulative rate of events per patient-year (EPPY) was 0.11 in HM II patients, compared with 0.09 EPPY in HW patients (P = 0.32). After introduction of the new cable design, incidence of cable damage in HM II patients dropped from 0.06 to 0 EPPY (P = 0.03), whereas pump thrombosis increased from 0.02 to 0.14 EPPY (P < 0.001) after the sealed graft was introduced. Pump thrombosis occurred in 4% of patients supported with HW with a sintered inflow cannula vs 15% with a non-sintered pump; the incidence changed from 0.10 to 0.07 EPPY in sintered pumps (P = 0.45). Kaplan-Meier analysis showed no differences over a period of 2.5 years for events when the HM II cohort with sealed graft and new cable design (n = 68) was compared with the HW group with a sintered cannula (P = 0.14). CONCLUSIONS: The modified cable strain relief of the HM II pump and the sintering of the inflow cannula of the HW pump demonstrated a significant reduction in the incidence of life-threatening pump-related complications, whereas the sealed inflow connector and outflow graft seem to be associated with a higher incidence of pump thrombosis. However, the overall incidence of pump-related complications after the latest design changes was similar for both pumps over a 2.5-year period.