10-Year Follow-Up of Patients With Everolimus-Eluting Versus Bare-Metal Stents After ST-Segment Elevation Myocardial Infarction.

BACKGROUND: Outcomes data for a durable-polymer everolimus-eluting stent (EES) at extended long-term follow-up in patients with ST-segment elevation myocardial infarction (STEMI) are unknown. OBJECTIVES: The aim of this study was to assess the 10-year outcomes of patients enrolled in the EXAMINATION (A Clinical Evaluation of Everolimus Eluting Coronary Stents in the Treatment of Patients With ST-Segment Elevation Myocardial Infarction) trial. METHODS: The EXAMINATION-EXTEND (10-Years Follow-Up of the EXAMINATION Trial) study is an investigator-driven 10-year follow-up of the EXAMINATION trial, which randomly assigned 1,498 patients with STEMI in a 1:1 ratio to receive either EES (n = 751) or bare-metal stents (n = 747). The primary endpoint was a patient-oriented composite endpoint of all-cause death, any myocardial infarction, or any revascularization. Secondary endpoints included a device-oriented composite endpoint of cardiac death, target vessel myocardial infarction, or target lesion revascularization; the individual components of the combined endpoints; and stent thrombosis. RESULTS: Complete 10-year clinical follow-up was obtained in 94.5% of the EES group and 95.9% of the bare-metal stent group. Rates of the patient-oriented composite endpoint and device-oriented composite endpoint were significantly reduced in the EES group (32.4% vs. 38.0% [hazard ratio: 0.81; 95% confidence interval: 0.68 to 0.96; p = 0.013] and 13.6% vs. 18.4% [hazard ratio: 0.72; 95% confidence interval: 0.55 to 0.93; p = 0.012], respectively), driven mainly by target lesion revascularization (5.7% vs. 8.8%; p = 0.018). The rate of definite stent thrombosis was similar in both groups (2.2% vs. 2.5%; p = 0.590). No differences were found between the groups in terms of target lesion revascularization (1.4% vs. 1.3%; p = 0.963) and definite or probable stent thrombosis (0.6% vs. 0.4%; p = 0.703) between 5 and 10 years. CONCLUSIONS: At 10-year follow-up, EES demonstrated confirmed superiority in combined patient- and device-oriented composite endpoints compared with bare-metal stents in patients with STEMI requiring primary percutaneous coronary intervention. Between 5- and 10-year follow-up, a low incidence of adverse cardiovascular events related to device failure was found in both groups. (10-Years Follow-Up of the EXAMINATION Trial; NCT04462315).

Long-term outcomes with balloon-expandable and self-expandable prostheses in patients undergoing transfemoral transcatheter aortic valve implantation for severe aortic stenosis.

BACKGROUND: Data on long-term outcomes in patients undergoing transcatheter aortic valve implantation (TAVI) is scarce. METHODS: We investigated long term outcomes of consecutive patients undergoing TAVI with balloon- and self-expandable bioprostheses (Edwards SAPIEN (ESV), Edwards Lifesciences Inc., Irvine, CA, USA; Medtronic Corevalve system (MCS), Medtronic Inc., Minneapolis, MN, USA). RESULTS: Among 628 patients (mean age 82.4 ±â€¯5.8 years, 55% female), 489 (77.8%) underwent transfemoral TAVI. 309 (63.2%) patients received a MCS prosthesis, whereas 180 (36.8%) patients were treated with an ESV prosthesis. The median duration of follow-up amounted to 5.2 years (range 3.4-8.3 years). All-cause mortality did not differ between the two groups (MCS 46.9%, ESV 53.4%, CI 95%: RR 1.21 [0.93-1.57], P = 0.15), whereas cardiac mortality was higher in the ESV cohort after 5 years of follow-up (MCS 35.1%, ESV 45.4%, CI 95%: RR 1.37 [1.01-1.86], P = 0.04). Structural valve deterioration, which was on average diagnosed 41.9 months (range 18-60 months) after TAVI, occurred in 8 cases (1.6%), resulting in one repeat intervention. CONCLUSIONS: While half of all patients died within 5 years after TAVI with no significant differences in all-cause mortality, structural valve deterioration was documented in <2% of cases.

Prosthesis-Patient Mismatch in Patients Undergoing Transcatheter Aortic Valve Replacement: From the STS/ACC TVT Registry.

BACKGROUND: Prosthesis-patient mismatch (PPM) after surgical aortic valve replacement (AVR) for aortic stenosis is generally associated with worse outcomes. Transcatheter AVR (TAVR) can achieve a larger valve orifice and the effects of PPM after TAVR are less well studied. OBJECTIVES: The authors utilized the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) registry to examine the frequency, predictors, and association with outcomes of PPM after TAVR in 62,125 patients enrolled between 2014 and 2017. METHODS: On the basis of the discharge echocardiographic effective valve area indexed to body surface area, PPM was classified as severe (<0.65 cm2/m2), moderate (0.65 to 0.85 cm2/m2), or none (>0.85 cm2/m2). Multivariable regression models were utilized to examine predictors of severe PPM as well as adjusted outcomes, including mortality, heart failure (HF) rehospitalization, stroke, and quality of life, at 1 year in 37,470 Medicare patients with claims linkage. RESULTS: Severe and moderate PPM were present following TAVR in 12% and 25% of patients, respectively. Predictors of severe PPM included small (≤23-mm diameter) valve prosthesis, valve-in-valve procedure, larger body surface area, female sex, younger age, non-white/Hispanic race, lower ejection fraction, atrial fibrillation, and severe mitral or tricuspid regurgitation. At 1 year, mortality was 17.2%, 15.6%, and 15.9% in severe, moderate, and no PPM patients, respectively (p = 0.02). HF rehospitalization had occurred in 14.7%, 12.8%, and 11.9% of patients with severe, moderate, and no PPM, respectively (p < 0.0001). There was no association of severe PPM with stroke or quality-of-life score at 1 year. CONCLUSIONS: Severe PPM after TAVR was present in 12% of patients and was associated with higher mortality and HF rehospitalization at 1 year. Further investigation is warranted into the prevention of severe PPM in patients undergoing TAVR.

Transcatheter Aortic Valve Replacement With a Repositionable Self-Expanding Prosthesis: The PORTICO-I Trial 1-Year Outcomes.

BACKGROUND: The new self-expanding, repositionable transcatheter heart valve (THV) system was designed for treatment of severe, symptomatic aortic stenosis in patients with high surgical risk. OBJECTIVES: The purpose of this study was to report 1-year outcomes of transcatheter aortic valve replacement with the new THV system. METHODS: This ongoing, international, multicenter study evaluated patients with severe, symptomatic aortic stenosis implanted with the THV via transfemoral access and follow-up at 30 days, 1 year, and annually through 5 years. The primary endpoint is all-cause mortality at 1 year; secondary endpoints include clinical outcomes and echocardiographic measurements, both adjudicated. RESULTS: A total of 941 patients (82.4 ± 5.9 years; 65.7% female; Society of Thoracic Surgeons Predicted Risk of Operative Mortality score: 5.8%) were enrolled and underwent an implant at 61 sites in Europe, Australia, and Canada. At 1 year, Kaplan-Meier estimates for all-cause mortality, cardiovascular mortality, disabling stroke rates, and myocardial infarction were 12.1%, 6.6%, 2.2%, and 2.5%, respectively. Mean aortic transvalvular gradient and aortic valve area were 8.66 mm Hg and 1.75 cm2, respectively. Paravalvular leakage was moderate or higher in 2.6% of patients with no severe leakage. New pacemaker rates were 18.7% and 21.3% for pacemaker naïve patients at 30 days and 1 year, respectively. Functional class, exercise capacity, and quality of life improved significantly from baseline to 1 year. CONCLUSIONS: Transcatheter aortic valve replacement with the new THV in patients who are at increased surgical risk is associated with low 1-year mortality and stroke rates. Favorable hemodynamic results at 1 year are observed with low transvalvular pressure gradient and incidence of significant paravalvular leakage. (5 Year Observation of Patients With PORTICO Valves [PORTICO-I]; NCT01802788).

What Is the Long-term Survival for Primary THA With Small-head Metal-on-metal Bearings?

BACKGROUND: Large-head metal-on-metal (MoM) bearing hip replacements have been shown to have a much higher rate of revision than other bearing surfaces. However, small-head (≤ 32 mm) MoM bearing surfaces have been in use for many years with several reports of satisfactory mid- to long-term survivorship. It is unclear whether the long-term survival of small-head MoM devices will continue to be satisfactory or whether the same concerns seen with the large-head MoM devices will ultimately become more prevalent. QUESTIONS/PURPOSES: We analyzed a large national registry to ask: (1) What is the 15-year Kaplan-Meier survivorship of primary conventional THA using small-head (≤ 32 mm) MoM bearing surfaces compared with large-head MoM bearing surfaces in primary THA? (2) Is there an increased rate of revision for adverse reaction to metal debris (ARMD) in this group of patients over time? METHODS: The Australian Orthopaedic Association National Joint Replacement Registry longitudinally maintains data on all primary and revision joint arthroplasties with nearly 100% capture. We analyzed all conventional primary THAs performed from Registry inception in September 1999 until December 31, 2015, in patients with a diagnosis of osteoarthritis and using MoM bearing surfaces ≤ 32 mm in diameter, defined as small-head MoM. The study group included 4838 primary THA with ≤ 32-mm MoM bearing surfaces. There were 2506 (51.8%) male patients and the median age of patients undergoing THA with a small-head MoM bearing surface was 64 years (range, 20-92 years of age). The outcome measure was the cumulative percent revision defined as the time to first revision using Kaplan-Meier estimates of survivorship at 15 years; reasons for revision and type of revision were also examined. We specifically investigated whether there was an increased risk of revision for ARMD in this MoM group compared with all other bearing surfaces. We compared these results with large-head MoM THAs (femoral head size > 32 mm). RESULTS: The cumulative percent revision for small-head MoM designs at 15 years was 8.5% (95% confidence interval [CI], 7.3-9.9). The cumulative percent revision for large-head MoM at 14 years was 27.4% (95% CI, 24.8-30.2). Prostheses with a large-head MoM articulation have a higher rate of revision than small-head MoM bearing surfaces (hazard ratio after 6 years, 5.14; 95% CI, 4.1-6.5; p < 0.001). Over time, there was a gradual increase in the diagnosis of ARMD for small-head MoM and the cumulative incidence of revision for ARMD was 0.8% at 15 years. CONCLUSIONS: Despite survival that is substantially greater than that of large-head MoM THAs, there has been a marked decrease in the use of small-head MoM designs in our registry. Although the reasons for this are likely multifactorial, the increasing incidence of revisions for ARMD among small-head MoM THAs is concerning. LEVEL OF EVIDENCE: Level III, therapeutic study.

Long-term follow-up of fenestrated endovascular repair for juxtarenal aortic aneurysm.

BACKGROUND: Fenestrated endovascular aneurysm repair (FEVAR) is increasingly being used for juxtarenal aortic aneurysms. The aim of this study was to review long-term results and assess the importance of changing stent-graft design on outcomes. METHODS: This was a retrospective review of all patients who underwent FEVAR within a single unit over 12 years (February 2003 to December 2015). Kaplan-Meier analysis of survival, and freedom from target vessel loss, aneurysm expansion, graft-related endoleak and secondary intervention was performed. Comparison between outcomes of less complex grafts (fewer than 3 fenestrations) and more complex grafts (3 or 4 fenestrations) was undertaken. RESULTS: Some 173 patients underwent FEVAR; median age was 76 (i.q.r. 70-79) years and 90·2 per cent were men. Median aneurysm diameter was 63 (59-71) mm and median follow-up was 34 (16-50) months. The adjusted primary technical operative success rate was 95·4 per cent. The in-hospital mortality rate was 5·2 per cent; there was no known aneurysm-related death during follow-up. Median survival was 7·1 (95 per cent c.i. 5·2 to 8·1) years and overall survival was 60·1 per cent (104 of 173). There was a trend towards an increasing number of fenestrations in the graft design over time. In-hospital mortality appeared higher when more complex stent-grafts were used (8 versus 2 per cent for stent-grafts with 3-4 versus fewer than 3 fenestrations; P = 0·059). Graft-related endoleaks were more common following deployment of stent-grafts with three or four fenestrations (12 of 90 versus 6 of 83; P < 0·001). CONCLUSION: Fenestrated endovascular aneurysm repair for juxtarenal aneurysm is associated with few aneurysm-related deaths in the long term. Significant numbers of secondary interventions are required, but the majority of these can be performed using an endovascular approach.

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.

Poor intermediate-term survival of the uncemented Optan anatomically adapted femoral component.

PURPOSE: We evaluated the 5-year survival of the uncemented Optan anatomically adapted femoral stem, with revision for aseptic loosening as the endpoint. METHODS: Between January 2004 and March 2007, 432 total hip arthroplasties (THAs) were performed in 432 patients. After follow-up for a mean time of 5 years, the patients were evaluated using the WOMAC questionnaire and plain radiography. Patients who were unable to attend the follow-up visit were contacted by telephone to determine whether they had had any revision surgery of their THA. RESULTS: Within 5 years, 39 patients (9%) had died of unrelated causes and 63 patients (15%) had been lost to follow-up. Of the remaining cohort, 224 patients (68%) had full follow-up while 88 patients (27%) were evaluated with WOMAC only and 18 patients (5%) were evaluated with radiography only. The mean WOMAC score of all evaluated patients was 21 (10-100). At 5-year follow-up, there were 26 stem revisions reported (6%), 14 hips (3%) showed aseptic loosening, and 12 hips (3%) had had a periprosthetic femoral fracture. The 5-year survival to revision for any reason was 94%. Worst-case analysis yielded a 5-year survival of 79%. INTERPRETATION: The 5-year survival for aseptic loosening of the Optan anatomically adapted femoral component was disappointing. Radiographic evaluation showed evidence of proximal radiolucencies and distal cortical bone hypertrophy, which we attribute to insufficient proximal bone in-growth and increased load transfer at the tip of the stem. We do not recommend the use of the Optan femoral stem.

10-year results of the uncemented Allofit press-fit cup in young patients.

BACKGROUND AND PURPOSE: Uncemented acetabular components in primary total hip arthroplasty (THA) are commonly used today, but few studies have evaluated their survival into the second decade in young and active patients. We report on a minimum 10-year follow-up of an uncemented press-fit acetabular component that is still in clinical use. METHODS: We examined the clinical and radiographic results of our first 121 consecutive cementless THAs using a cementless, grit-blasted, non-porous, titanium alloy press-fit cup (Allofit; Zimmer Inc., Warsaw, IN) without additional screw fixation in 116 patients. Mean age at surgery was 51 (21-60) years. Mean time of follow-up evaluation was 11 (10-12) years. RESULTS: At final follow-up, 8 patients had died (8 hips), and 1 patient (1 hip) was lost to follow-up. 3 hips in 3 patients had undergone acetabular revision, 2 for deep infection and 1 for aseptic acetabular loosening. There were no impending revisions at the most recent follow-up. We did not detect periacetabular osteolysis or loosening on plain radiographs in those hips that were evaluated radiographically (n = 90; 83% of the hips available at a minimum of 10 years). Kaplan-Meier survival analysis using revision of the acetabular component for any reason (including isolated inlay revisions) as endpoint estimated the 11-year survival rate at 98% (95% CI: 92-99). INTERPRETATION: Uncemented acetabular fixation using the Allofit press-fit cup without additional screws was excellent into early in the second decade in this young and active patient cohort. The rate of complications related to the liner and to osteolysis was low.

Total hip replacement for the treatment of acute femoral neck fractures: results from the National Joint Registry of England and Wales at 3-5 years after surgery.

INTRODUCTION: This paper describes, for the first time, the outcomes of patients undergoing total hip replacement for acute fractured neck of femur (#NOF) as recorded by the National Joint Registry of England and Wales (NJR). METHODS: In the NJR we identified 1,302 of 157,232 Hospital Episode Statistics linked patients who had been recorded as having a total hip replacement for acute #NOF between April 2003 and November 2008. RESULTS: The revision rate at five years for fully uncemented components was 4.1% (95% confidence interval [CI]: 2.2-7.3%), for hybrid it was 2.2% (95% CI: 0.9%-5.3%) and for fully cemented components 0.9% (95% CI: 0.4-2.0%). Five-year revision rates were increased for those whose operations were performed via a posterior versus a lateral approach. The Kaplan-Meier estimate of 30-day mortality was 1.4% (95% CI: 1.0-2.4%), which is over double the 30-day mortality rate for total hip replacement identified by the Office for National Statistics. The mean length of stay was also increased for those undergoing total hip replacements for #NOF compared with non-emergency indications. CONCLUSIONS: Our data suggest that total hip replacements for acute #NOF give comparable results with total hip replacements for other indications.

Diseño personalizado de una interfaz mioeléctrica para una prótesis de miembro superior / Custom design of a myoelectric interface for upper limb prostheses

Desde los años sesenta se utilizan las señales electromoigráficas (EMG) como señales de control para prótesis actuadas por servomotores, así como en la estimulación de músculos que sufren de parálisis o de atrofia parcial. Mediante el avance tecnológico se ha logrado mejorar el diseño, así como la fabricación de sistemas protésicos, que funcionan como extensiones de algún miembro del cuerpo humano, agregando además con los nuevos diseños, características básicas como: flexibilidad, estética morfológica, incremento de la relación resistencia/peso así como multifuncionalidad. Una prótesis mioeléctrica es una estructura desarrollada con el fin de reemplazar una parte o la totalidad de un miembro del cuerpo humano, lo mismo que suplir las funciones perdidas de este, sin dejar de lado la imagen corporal del paciente. Estas prótesis son accionadas por actuadores que se controlan a través de señales EMG, las cuales se obtiene mediante agujas intramusculares superficiales o por medio de electrodos colocados en el muñón del paciente. Este tipo de prótesis es cada vez más aceptado por personas con amputación de mano, ya que proporciona un mejor desempeño y permite el incremento de funcionalidad para el paciente que la utiliza, debido a que su control es más sencillo.

Since 60’s electromiographical signals (EMG’s) are used like a control signals for prostheses acted by servomotors, as well as stimulation of muscles that are affected due to partial or total paralysis. By means of technological advance, it has been possible to improve the design as well as the production of prosthetic systems that work as extensions of some member of human body, adding with the new designs also basic characteristics as: flexibility, aesthetic morphology, and superior strength/weight relationship, as well as multi-functionality. Mioelectric prosthesis is a structure developed with the purpose of replacing a part or the entirety member of human body, same as to replace the lost functions of this, without leaving aside patient's corporal image. These prostheses are acted by actuators that are controlled through EMG signals, which are obtained by means of intramuscular or superficial needles, or by means of electrodes placed in patient's stump. This class of prostheses is more and more accepted by people with hand amputation since it provides a better acting, that which allows a superior functionality for patient that uses it, because its control is simpler.

Charnley low-friction arthroplasty of the hip. Five to 25 years survivorship in a general hospital.

BACKGROUND: Some studies have raised the question about whether the good results obtained with the Charnley prosthesis could be replicated at general hospitals when it comes to the frequency of early complications and failure rates, both of which would be higher than those published by centres devoted to hip arthroplasties. METHODS: We reviewed the results of 404 Low Friction Arthroplasties of the hip implanted between 1976 and 1993 in a general hospital by general orthopaedic surgeons. For the survival analysis, the end-point chosen would be the chirurgical revision of any of the prosthetic components for whatever reason. RESULTS: The complications were 16 dislocations (4%), 14 deep infections (3.5%), 2 neurological injuries (0,5%) and 5 clinical deep venous thromboses (1.2%) (2 pulmonary embolisms). The survival rate at 25 years, both for stem and cup, was 83%. Survival was higher in those arthroplasties implanted in patients older than 60 years, with statistical significance. CONCLUSION: Low Friction Arthroplasty undertaken at general hospitals by general orthopaedic surgeons feature similar outcomes to those found in centres devoted to hip surgery.