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"Reoperation - statistics "
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A Fully Magnetically Levitated Left Ventricular Assist Device — Final Report
2019
Patients with advanced heart failure were randomly assigned to receive a centrifugal-flow or an axial-flow LVAD. At 2 years, the centrifugal-flow LVAD was associated with less pump replacement and with longer survival free of disabling stroke or reoperation to replace or remove a malfunctioning device.
Journal Article
The clinical and cost-effectiveness of total versus partial knee replacement in patients with medial compartment osteoarthritis (TOPKAT): 5-year outcomes of a randomised controlled trial
2019
Late-stage isolated medial knee osteoarthritis can be treated with total knee replacement (TKR) or partial knee replacement (PKR). There is high variation in treatment choice and little robust evidence to guide selection. The Total or Partial Knee Arthroplasty Trial (TOPKAT) therefore aims to assess the clinical effectiveness and cost-effectiveness of TKR versus PKR in patients with medial compartment osteoarthritis of the knee, and this represents an analysis of the main endpoints at 5 years.
Our multicentre, pragmatic randomised controlled trial was done at 27 UK sites. We used a combined expertise-based and equipoise-based approach, in which patients with isolated osteoarthritis of the medial compartment of the knee and who satisfied general requirements for a medial PKR were randomly assigned (1:1) to receive PKR or TKR by surgeons who were either expert in and willing to perform both surgeries or by a surgeon with particular expertise in the allocated procedure. The primary endpoint was the Oxford Knee Score (OKS) 5 years after randomisation in all patients assigned to groups. Health-care costs (in UK 2017 prices) and cost-effectiveness were also assessed. This trial is registered with ISRCTN (ISRCTN03013488) and ClinicalTrials.gov (NCT01352247).
Between Jan 18, 2010, and Sept 30, 2013, we assessed 962 patients for their eligibility, of whom 431 (45%) patients were excluded (121 [13%] patients did not meet the inclusion criteria and 310 [32%] patients declined to participate) and 528 (55%) patients were randomly assigned to groups. 94% of participants responded to the follow-up survey 5 years after their operation. At the 5-year follow-up, we found no difference in OKS between groups (mean difference 1·04, 95% CI −0·42 to 2·50; p=0·159). In our within-trial cost-effectiveness analysis, we found that PKR was more effective (0·240 additional quality-adjusted life-years, 95% CI 0·046 to 0·434) and less expensive (−£910, 95% CI −1503 to −317) than TKR during the 5 years of follow-up. This finding was a result of slightly better outcomes, lower costs of surgery, and lower follow-up health-care costs with PKR than TKR.
Both TKR and PKR are effective, offer similar clinical outcomes, and result in a similar incidence of re-operations and complications. Based on our clinical findings, and results regarding the lower costs and better cost-effectiveness with PKR during the 5-year study period, we suggest that PKR should be considered the first choice for patients with late-stage isolated medial compartment osteoarthritis.
National Institute for Health Research Health Technology Assessment Programme.
Journal Article
Invasive versus conservative strategy in patients aged 80 years or older with non-ST-elevation myocardial infarction or unstable angina pectoris (After Eighty study): an open-label randomised controlled trial
by
Endresen, Knut
,
Ranhoff, Anette Hylen
,
Bendz, Bjørn
in
Aged, 80 and over
,
Angina pectoris
,
Angina, Unstable - mortality
2016
Non-ST-elevation myocardial infarction (NSTEMI) and unstable angina pectoris are frequent causes of hospital admission in the elderly. However, clinical trials targeting this population are scarce, and these patients are less likely to receive treatment according to guidelines. We aimed to investigate whether this population would benefit from an early invasive strategy versus a conservative strategy.
In this open-label randomised controlled multicentre trial, patients aged 80 years or older with NSTEMI or unstable angina admitted to 16 hospitals in the South-East Health Region of Norway were randomly assigned to an invasive strategy (including early coronary angiography with immediate assessment for percutaneous coronary intervention, coronary artery bypass graft, and optimum medical treatment) or to a conservative strategy (optimum medical treatment alone). A permuted block randomisation was generated by the Centre for Biostatistics and Epidemiology with stratification on the inclusion hospitals in opaque concealed envelopes, and sealed envelopes with consecutive inclusion numbers were made. The primary outcome was a composite of myocardial infarction, need for urgent revascularisation, stroke, and death and was assessed between Dec 10, 2010, and Nov 18, 2014. An intention-to-treat analysis was used. This study is registered with ClinicalTrials.gov, number NCT01255540.
During a median follow-up of 1·53 years of participants recruited between Dec 10, 2010, and Feb 21, 2014, the primary outcome occurred in 93 (40·6%) of 229 patients assigned to the invasive group and 140 (61·4%) of 228 patients assigned to the conservative group (hazard ratio [HR] 0·53 [95% CI 0·41–0·69], p=0·0001). Five patients dropped out of the invasive group and one from the conservative group. HRs for the four components of the primary composite endpoint were 0·52 (0·35–0·76; p=0·0010) for myocardial infarction, 0·19 (0·07–0·52; p=0·0010) for the need for urgent revascularisation, 0·60 (0·25–1·46; p=0·2650) for stroke, and 0·89 (0·62–1·28; p=0·5340) for death from any cause. The invasive group had four (1·7%) major and 23 (10·0%) minor bleeding complications whereas the conservative group had four (1·8%) major and 16 (7·0%) minor bleeding complications.
In patients aged 80 years or more with NSTEMI or unstable angina, an invasive strategy is superior to a conservative strategy in the reduction of composite events. Efficacy of the invasive strategy was diluted with increasing age (after adjustment for creatinine and effect modification). The two strategies did not differ in terms of bleeding complications.
Norwegian Health Association (ExtraStiftelsen) and Inger and John Fredriksen Heart Foundation.
Journal Article
Adjunctive Middle Meningeal Artery Embolization for Subdural Hematoma
by
Levitt, Michael R.
,
Santarelli, Justin
,
Schirmer, Clemens M.
in
Aged
,
Aged, 80 and over
,
Aging
2024
In patients with subdural hematoma and an indication for surgical evacuation, middle meningeal artery embolization plus surgery led to a lower risk of reoperation for recurrence or progression within 90 days than surgery alone.
Journal Article
Total Hip Arthroplasty or Hemiarthroplasty for Hip Fracture
by
Guyatt, Gordon
,
Schemitsch, Emil H
,
Sprague, Sheila
in
Aged
,
Aged, 80 and over
,
Arthroplasty, Replacement, Hip - adverse effects
2019
Patients who were 50 years of age or older and had a displaced femoral neck fracture were randomly assigned to total hip arthroplasty or hemiarthroplasty. Total hip arthroplasty did not differ significantly from hemiarthroplasty with regard to the incidence of secondary procedures and led to clinically unimportant improvement over hemiarthroplasty in function over 24 months.
Journal Article
Decompression with or without Fusion in Degenerative Lumbar Spondylolisthesis
2021
In a randomized trial conducted in Norway, decompression surgery alone was noninferior to decompression with instrumented fusion with respect to the percentage of patients who had a 30% reduction on a scale of pain and disability over a period of 2 years, with a noninferiority margin of −15 percentage points.
Journal Article
Laminectomy plus Fusion versus Laminectomy Alone for Lumbar Spondylolisthesis
by
Terrin, Norma
,
Amin-Hanjani, Sepideh
,
Coumans, Jean-Valery C.E
in
Aged
,
Aged, 80 and over
,
Back
2016
Among patients with spondylolisthesis and lumbar spinal stenosis, laminectomy with fusion was associated with modestly greater improvement in physical health–related quality of life than laminectomy alone but not with significantly greater reduction in disability related to back pain.
The increased use of the lumbar spinal fusion procedure in the United States, along with the wide variation in practice, is attracting interest from multiple stakeholders, including patients, physicians, payers, and policymakers. In a report published in 2014, spinal fusion (465,000 hospital-based procedures in 2011) accounted for the highest aggregate hospital costs ($12.8 billion in 2011) of any surgical procedure performed in U.S. hospitals.
1
The randomized, controlled Spine Patient Outcomes Research Trial (SPORT) showed that surgery was superior to nonoperative care for the management of lumbar degenerative spondylolisthesis.
2
In SPORT, most patients in the surgical group were treated by means . . .
Journal Article
Two-Year Outcomes with a Magnetically Levitated Cardiac Pump in Heart Failure
2018
In a randomized trial, 366 patients with advanced heart failure received a centrifugal- or axial-flow LVAD. At 2 years, the centrifugal-flow LVAD was superior with regard to survival free of disabling stroke or reoperation to replace or remove a malfunctioning device.
Journal Article
A Randomized, Controlled Trial of Fusion Surgery for Lumbar Spinal Stenosis
2016
In this randomized, controlled trial comparing decompression surgery alone with decompression surgery plus fusion surgery for patients with lumbar spinal stenosis, there was no significant between-group difference in clinical outcomes at 2 and 5 years.
Lumbar spinal stenosis is caused by a gradual narrowing of the spinal canal. Patients with lumbar spinal stenosis typically present with low back pain and leg pain, which occur especially when they are walking. This degenerative condition severely restricts function, walking ability, and quality of life. Lumbar spinal stenosis has become the most common indication for spinal surgery,
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–
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and studies have shown that surgical treatment in selected patients is more successful than conservative alternatives.
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–
7
As the use of surgery to treat lumbar spinal stenosis has increased during the past decades, so has the complexity of the surgical procedures. . . .
Journal Article
Embolization of the Middle Meningeal Artery for Chronic Subdural Hematoma
2025
Among patients receiving surgical or nonsurgical standard treatment for chronic subdural hematoma, adjunctive middle meningeal artery embolization reduced the risk of treatment failure within 180 days.
Journal Article