Treatment Option For Older Patients Research Articles

Nusinersen in Adults with 5q Spinal Muscular Atrophy: a Systematic Review and Meta-analysis.

Evidence for nusinersen administration in adult 5q spinal muscular atrophy (5q-SMA) patients is scarce and based on real-world observational data. The present systematic review and meta-analysis aimed to explore the efficacy and safety of nusinersen in patients older than 12years of age with 5q-SMA. We searched MEDLINE, EMBASE, the Cochrane Library, and grey literature through April 2021. Cross-sectional studies, case reports, review articles, and studies with follow-up less than 6months were excluded. We included 12 records (seven case-series, five cohorts) representing 11 population cohorts and enrolling 428 SMA patients. We observed statistically significant improvements on motor function Hammersmith Functional Motor Scale Expanded (HFMSE) and Revised Upper Limb Module (RULM) scores at the longest follow-up assessments [SMD = 0.17(95% CI 0.01-0.33), SMD = 0.22(95% CI 0.06-0.38), respectively]. HFMSE and RULM significant improvements were also detected at the subgroup analysis during 10 and 14months. HFMSE and RULM amelioration occurred earlier in patients with SMA type 3 or 4 during short-term analysis (≤ 6months). 6-min walk tests (6MWT) and pulmonary function tests did not change. Minimal clinically important differences in HFMSEand RULMwere observed in 43.3% (95% CI 34.5-52.3) and 38.9% (95% CI 27.7-50.7), respectively. Severe adverse events were reported in 2% (95% CI 0-5.8). Treatment withdrawal rate was 3% (95% CI 0.5-6.6). Despite the low quality of evidence and the unmet need for randomized data to establish the safety and efficacy of nusinersen in adults, our meta-analysis confirms that nusinersen is a valuable treatment option for older patients with longer-disease duration.Trial registration: PROSPERO database CRD42020223109.

Evaluation of real‐world effectiveness of perampanel in Japanese adults and older adults with epilepsy

While previous studies have demonstrated the safety and effectiveness of perampanel (PER) in combination with other anti-seizure medications in adult patients, data for older patients are limited. This study aimed to confirm real-world safety and effectiveness of combination treatment with PER in Japanese patients with focal seizures with or without focal to bilateral tonic-clonic seizures (FBTCS) or generalised tonic-clonic seizures (GTCS) according to age subgroups (<65 and ≥65 years of age). This large-sample prospective post-marketing observational study included a 24-52-week observation period after the first PER treatment. Safety was assessed according to adverse drug reactions (ADRs) and efficacy was evaluated based on the 50% responder rate and rates of overall symptom improvement. Among the 3,808 patients who were enrolled, 3,716 (3,026 patients aged <65 years and 690 patients aged ≥65 years) and 3,272 were included in the safety and efficacy analysis datasets, respectively. ADRs were reported for 1,247 patients (33.6%) in the safety analysis dataset. Of these, 36.2% and 22.2% were aged <65 years and ≥65 years, respectively, and the most common ADRs were somnolence (11.6%, 5.5%) and dizziness (9.7%, 5.4%). The 50% responder rates in patients aged <65 years and those ≥65 years were 60.1% and 89.0% for those with focal aware seizures (FAS) with motor signs; 48.0% and 60.0% for FAS without motor signs; 47.4% and 80.2% for focal impaired awareness seizures; 70.8% and 93.4% for FBTCS; and 63.6% and 88.9% for GTCS, respectively. The improvement rates of symptoms/conditions were also higher in patients aged ≥65 years than those <65 years. PER was effective in reducing seizure frequency and was safe, especially in older patients. PER may be a clinical treatment option for older patients with seizure disorders.

Aspacytarabine (BST-236) As Monotherapy Is Safe, Well-Tolerated and Effective for the Treatment of Adults with Newly Diagnosed Acute Myeloid Leukemia Unfit for Intensive Therapy. Results of a Phase 2 Study

Aspacytarabine (BST-236) As Monotherapy Is Safe, Well-Tolerated and Effective for the Treatment of Adults with Newly Diagnosed Acute Myeloid Leukemia Unfit for Intensive Therapy. Results of a Phase 2 Study

Treatment patterns and outcomes in older patients with advanced malignant pleural mesothelioma: Analyses of Surveillance, Epidemiology, and End Results-Medicare data.

BackgroundMalignant mesothelioma is a rare neoplasm associated with asbestos exposure. Characterizing treatment patterns and outcomes of older patients with advanced malignant pleural mesothelioma (MPM) is important to understand the unmet needs of this population.AimTo evaluate the demographic and clinical characteristics, treatment patterns, and outcomes among older patients diagnosed with advanced MPM in the United States between 2007 and 2013.MethodsThis was a retrospective cohort study using Surveillance, Epidemiology, and End Results (SEER) data linked with Medicare claims. We included patients who were age 66 or older at the time of their primary MPM diagnosis between 2007 and 2013 and followed them through 2014. Treated patients who received first‐line chemotherapy with pemetrexed and platinum within 90 days of diagnosis, second‐line, or third‐line therapy were identified for evaluation of outcomes.ResultsThere were 666 older patients with advanced MPM, of whom 82% were male, 87% White, 78% stage IV, and 70% had no mobility limitation indicators at diagnosis. There were 262 patients who received first‐line chemotherapy for advanced MPM, most of whom (80%; n = 209) received pemetrexed‐platinum. Of these 209 patients, 41% (n = 86) initiated second‐line therapy, and 26% (n = 22) initiated third‐line therapy. Median overall survival for the cohort of 209 patients was 7.2 months. Patients with epithelioid histology had better median overall survival (12.2 months) compared with other histologies (4.4–5.6 months). Within 90 days of diagnosis of advanced MPM, 78% of patients were hospitalized, 52% visited an emergency department, and 21% had hospice care. The 2‐year cost of care was over $100 000 for all patients with advanced MPM treated with first‐line pemetrexed‐platinum.ConclusionsAlthough first‐line systemic anticancer treatment was generally consistent with guidelines (e.g., pemetrexed‐platinum), poor patient outcomes highlight the need for effective treatment options for older patients with advanced MPM.

Clipping of unruptured cerebral aneurysms : Are older patients at higher risk?

BackgroundThe incidence of aneurysms is steadily increasing in older patients due to the aging population. This study compared radiological parameters as well as clinical outcomes between patients younger than 65 years and those over 65 years of age, with special respect to individual treatment options.MethodsRetrospective data were obtained for patients with cerebral aneurysms at a single academic institution within a 7-year period. Data reviewed included admission protocols, patient charts, operating reports as well as outpatient clinic charts. Aneurysmal characteristics as well as surgical outcome were compared between older patients, defined as patients older than 65 years of age, and a control group of patients younger than 65 years of age. To evaluate and compare individual clinical characteristics various scores including the Hunt and Hess score, the Fisher score, and the Glasgow outcome scale were used.ResultsA total of 347 patients were included in the final analysis. The control group included 290 patients, while 57 patients were in the older patient group. Neither the Hunt and Hess scores nor Fisher scores were significantly correlated to patient age. The Glasgow outcome scale was significantly lower in the older group after clipping of ruptured aneurysms (p < 0.000) but not significantly different after clipping of unruptured aneurysms (p = 0.793).ConclusionPostoperative Glasgow outcome scale scores were not significantly different after clipping of unruptured cerebral aneurysms approximately 1 cm in diameter in older patients compared to the younger age group. Therefore, clipping of unruptured cerebral aneurysms may also be a valuable treatment option for older patients.

New Treatment Options for Older Patients with Acute Myeloid Leukemia.

The treatment of acute myeloid leukemia (AML) has evolved considerably over the past several years. Advances in the field have historically benefited younger patients; however, a growing understanding of the molecular basis of leukemogenesis has brought multiple targeted agents to the clinic for patients of all ages. These therapies have expanded the therapeutic landscape for elderly patients from more than best supportive care and low-intensity monotherapy. In general, we currently utilize a backbone regimen of a hypomethylating agent (HMA) or low-intensity chemotherapy with the BCL-2 inhibitor venetoclax for the majority of elderly patients with newly diagnosed AML. For patients with targetable mutations, we employ a doublet/triplet strategy of HMA + a targeted inhibitor +/- venetoclax, often in the context of a clinical trial. CPX-351 is reserved for patients with secondary or therapy-related AML. In this review, we will outline our approach to the treatment of elderly patients with AML, with particular emphasis on recently approved agents and emerging novel therapies.

The Role of Radiation Therapy in the Older Patient.

Older patients represent a unique subgroup of the cancer patient population for which the role of radiation therapy (RT) requires special consideration. This review will discuss many of these considerations as well as various radiation treatment techniques in the context of a variety of disease sites. Several recent studies give insight into the management of older cancer patients considering their age, performance status, comorbid conditions, quality of life, genetics, cost, and individual goals. RT plays an evolving and pivotal role in providing optimal care for this population. Recent advances in RT technique allow for more precise treatment delivery and reduced toxicity. Studies evaluating the use of radiation therapy in breast, brain, lung, prostate, rectal, pancreatic, esophageal, and oligometastatic cancer are summarized and discussed in the context of treating the older patient population. Individual age, performance and functional status, comorbid conditions, and patients' objectives and goals should all be considered when presenting treatment options for older patients and age alone should not disqualify patients from curative intent treatments. When possible, hypofractionated courses should be utilized as outcomes are often equivalent and toxicities are reduced. In many cases, RT may be preferable to other treatment options due to decreased toxicity profile and acceptable disease control.

Should atraumatic restorative treatment be the preferred treatment for older patients?

Design Randomised controlled trial study.Case selection Ninety-nine subjects were chosen from 219 potential subjects. The 99 who met the inclusion criteria were randomly allocated to two treatment groups: atraumatic restorative treatment (ART) and conventional treatment (CT). To be selected, patients needed to be 65 years or over, follow oral hygiene guidance and have one or more painless dentinal carious lesions. To establish suitability, a full dental examination was performed by two calibrated dentists. Prior to receiving ART or CT, all participants received standard dental care (including extractions, non-surgical treatment and oral hygiene instructions). Following ART or CT, a dental nurse collected data regarding patient treatment preferences and a calibrated independent dentist, blind to the treatment allocation, reviewed restorations six months, one year, two years and five years after treatment.Data analysis The Cox proportional-hazards (PH) model was used to assess the cumulative survival of the variables ART and CT between the intervals. Bootstrapping was employed to estimate standard errors since the multiple restorations required by many patients were not necessarily independent of each other.Results Of the 99 subjects included, only 28 (ART: 15, CT: 13) remained after five years. After five years, of the 300 restorations undertaken, 15 ART restorations and 16 CT restorations failed. The cumulative probability of restoration survival was 85% and 79% (p = 0.8095) for ART and CT, respectively, with the Cox PH model showing the treatment used had no effect on the restorations' survival.Conclusions No significant difference was noted between the treatment methods used in terms of survival of the restorations. However, it is worth noting that 64.5% of participants preferred to have dental treatment without local anaesthesia and 71.1% without the use of a dental drill. Therefore, ART was a favourable treatment option in older patients, particularly those unable to attend the dental surgery.

1582. In Vitro Activity of Ceftolozane/Tazobactam against Enterobacterales and Pseudomonas aeruginosa Isolates from Geriatric Patients in the Asia/Pacific region – SMART 2016-2018

BackgroundCeftolozane/tazobactam (C/T) is an antipseudomonal cephalosporin combined with a β-lactamase inhibitor approved by FDA and EMA for complicated urinary tract and intraabdominal infections, and hospital-acquired and ventilator-associated bacterial pneumonia. We evaluated the activity of C/T against isolates collected from patients ≥65 years old as part of the SMART surveillance program in Asia/Pacific.MethodsIn 2016-2018, 49 clinical laboratories in Australia, Hong Kong, Malaysia, New Zealand, Philippines, Singapore, Korea, Taiwan, Thailand, and Vietnam each collected up to 250 consecutive gram-negative pathogens per year. Susceptibility was determined using CLSI broth microdilution and breakpoints. C/T-nonsusceptible (NS) Enterobacterales (ENT) and P. aeruginosa (PA) isolates were screened by PCR and sequenced for genes encoding β-lactamases (except ENT from 1 site in Taiwan).Results2082 PA (68.3% lower respiratory tract, 12.7% intraabdominal, 15.1% urinary tract, and 3.0% bloodstream infection isolates) and 8181 ENT isolates (29.8%, 27.8%, 32.5%, and 9.2%, respectively) were collected from patients ≥65 years old. In vitro susceptibility of PA and ENT stratified by length of hospital stay at time of specimen collection (LOS) is shown (Table).C/T maintained activity against 75.5% of 518 P/T-NS, 67.9% of 395 cefepime-NS, and 71.6% of 377 meropenem-NS PA isolates. Among 136 C/T-NS PA isolates, 44.9% carried metallo-β-lactamases (MBL), 0.7% KPC, 1.5% GES carbapenemases, 5.9% only ESBL, and in 47.1% no acquired β-lactamases were detected. Among 878 characterized C/T-NS ENT, 14.1% carried MBL, 5.2% KPC, 3.3% OXA-48-like carbapenemases, and 53.5% AmpC and/or ESBL; no acquired β-lactamases were detected in 23.8% of isolates, of which 89.5% were species with intrinsic AmpC.Table ConclusionSusceptibility of PA and ENT to all studied agents was lower for isolates collected ≥48 than < 48 hours post-admission. C/T was active against >92% of PA in both strata, 7-29 percentage points higher than the studied comparators except amikacin, and against >84% of ENT, 4-30% higher than the comparators except meropenem and amikacin. C/T is a potential new treatment option for older patients with infections caused by ENT and PA in Asia/Pacific.DisclosuresSibylle Lob, PhD, IHMA (Employee)Pfizer, Inc. (Consultant) Wei-Ting Chen, MD, Merck, Sharp & Dohme, Taiwan (Employee) Yivonne Khoo, PhD, Merck, Sharp & Dohme, Malaysia (Employee) Kanchan Balwani, MBBS, MS, Merck, Sharp & Dohme, Hong Kong (Employee) Katherine Young, MS, Merck & Co., Inc. (Employee, Shareholder)Merck & Co., Inc. (Employee, Shareholder) Mary Motyl, PhD, Merck & Co, Inc (Employee, Shareholder) Daniel F. Sahm, PhD, IHMA (Employee)Pfizer, Inc. (Consultant)Shionogi & Co., Ltd. (Independent Contractor)

Delirium, functional decline and quality of life after transcatheter aortic valve implantation: An explorative study.

AimTranscatheter aortic valve implantation (TAVI) has become an important treatment option for older patients with severe aortic stenosis. However, not all patients benefit from this procedure in terms of functional outcome and quality of life. This complicates patient selection and shared decision‐making. Postoperative delirium might negatively affect patient outcomes after TAVI. We therefore studied the potential relationship between postoperative delirium and functional outcome, and how this impacts quality of life after TAVI.MethodsThis was a prospective cohort study of 91 consecutive patients undergoing TAVI between 2015 and 2017 at an academic medical center. All patients underwent a Comprehensive Geriatric Assessment before TAVI. Delirium symptoms were assessed daily during hospitalization. Follow up was carried out between 6 and 12 months postprocedure. The primary outcome was functional decline or death at follow up. Secondarily, we measured quality of life at follow up.ResultsThe incidence of postoperative delirium was 15.4%. In total, 38.5% of patients experienced functional decline, and 11.0% died during a median follow‐up period of 7 months. Delirium resulted in a fourfold increased odds of the combined outcome of functional decline or death. Quality of life was lower in patients that experienced this outcome.ConclusionIn a cohort of TAVI patients, functional decline or death was a frequent outcome in the first year postprocedure. Postoperative delirium increased the odds for this outcome substantially. This suggests that delirium risk should be an important factor to consider in shared decision‐making for TAVI patients. Geriatr Gerontol Int 2020; 20: 1202–1207.

Optimizing the Treatment of Moderate-to-Severe Psoriasis in Older Adults.

Psoriasis is a lifelong disease and its prevalence in older adults continues to increase as the population ages. Therefore, it is important for physicians to understand the management of the disease in this population. While the management of psoriasis in older adults is similar to the management of patients below the age of 65years, there are special considerations when treating older patients. Older patients may have more comorbidities, more immunosuppression, and are often taking additional medications that can interact with those being used to treat psoriasis. Safer and more effective treatment options for psoriasis have been introduced in recent years, particularly injectable biological agents. Unfortunately, older patients with psoriasis are oftentimes underrepresented in the clinical trials for these new medications. Subsequent studies have focused on the safety and efficacy of these medications in older adults. The results of these studies demonstrate that biologic agents are well tolerated in older patients and are more effective in treating psoriasis than conventional systemic therapies. In addition, new small-molecule agents such as apremilast also offer an effective and safe treatment option for older patients with psoriasis. The results of these studies can help guide physicians with incorporating these newer medications into the treatment regimen of older psoriasis patients. Despite the proven safety and efficacy of biologic agents, their frequency of use in elderly patients is still almost half of that in non-elderly patients.

Current Treatment Options for Older Patients with Hodgkin Lymphoma.

Older adults with Hodgkin lymphoma (HL), commonly defined as age ≥ 60years, represent approximately 20% of the total HL population. Historically, they have significantly inferior outcomes compared with younger patients. The cause of this is multifactorial, including biologic differences (e.g., mixed cellularity and EBV-related disease); high incidence of advanced stage disease; and frequency of comorbidities and decreased organ reserve leading to poorer tolerability of therapy with increased toxicity, including treatment-related mortality. Pretreatment evaluation for older HL patients should entail a geriatric assessment (GA), with evaluation of functional status and comorbidities (e.g., geriatric cumulative illness rating scale, CIRS-G) to determine fitness. Furthermore, treatment selection should be based in part on GA, with fit older patients receiving curative chemotherapy-based regimens and unfit or frail patients considering less intensive or non-chemotherapy-based platforms. Additionally, there may be consideration for pre-phase of therapy (e.g., pulse steroids) in order to improve performance status. The inclusion of anthracycline therapy appears important, while bleomycin-containing regimens (e.g., ABVD) may be associated with prohibitive pulmonary toxicity, and intensive therapies such as BEACOPP are too toxic. benefit ratio/benefit ratio, a priori omission of bleomycin may also be considered (i.e., AVD), especially for patients older than 70years of age. In addition, newer regimens for older HL patients integrating novel therapeutic agents into frontline treatment have emerged as effective and tolerable options. Data incorporating brentuximab vedotin sequentially before and after AVD chemotherapy represent the best-reported outcomes in older HL patients to date. In the relapsed/refractory setting, salvage chemotherapy regimens followed by autologous stem cell transplantation should be considered for fit patients, while less intensive treatment, including the use of novel targeted agents, is an option for unfit or frail patients. In this review, we examine the epidemiology, importance of GA, and current treatment options for older HL patients.

Impact of aging on immune-related adverse events generated by anti–programmed death (ligand)PD-(L)1 therapies

BackgroundAging is an important risk factor for cancers and is associated with poor prognosis. Weakness of the immune system, also called immunosenescence may occur with older age. The impact of aging on efficacy and safety of immune checkpoint blockers, such as anti-programmed death (ligand) PD-(L)1, remains undetermined. This study aims to evaluate the incidence of immune-related adverse events (irAEs) in patients aged 70 years or older than their younger counterparts. MethodsPatients with advanced solid tumors treated at Gustave Roussy with an anti–PD-(L)1 monotherapy between June 2014 and October 2017 were prospectively included within the dedicated irAEs pharmacovigilance registry REISAMIC (Registre des Effets Indésirables Sévères des Anticorps Monoclonaux Immunomodulateurs en Cancérologie). The incidence of irAEs of grade ≥II was compared between patients aged ≥70 (old patients, OP) versus patients aged < 70 years (young patients, YP) using a chi-squared test. Survivals were estimated using the Kaplan-Meier method. ResultsAmong the 603 patients treated by anti-PD(L)1, 191 were ≥70 y.o (OP) and 424 < 70 y.o (YP). The median (range) age of OP and YP were respectively 77 (70–93) and 59 years old (17–69). A total of 165 irAEs occurred in these patients (103 grade II and 58 grade III–IV). The overall incidence of grade ≥II irAEs was higher in OP than in YP (33% versus 25%, p = 0.03). In addition, OP were more prone of having multiples irAEs compared with YP (p = 0.037). Skin toxicities were more frequent in OP than in YP (p = 0.007) but endocrine toxicities were less frequent in OP than in YP (p = 0.044). This higher level of irAEs seems to be responsible for a higher rate of treatment discontinuation in OP (p = 0.2). There was no statistical difference in median time to toxicity, exposure to steroids or survival between the two groups. ConclusionAlthough anti-PD-(L)1 immunotherapies remain an acceptable treatment option for older patients, prescribers should be aware that irAEs are more frequent in the elderly. Further translational studies are warranted to better understand the relationship between aging and irAEs.

Methotrexate shows benefit in a subset of patients with severe hidradenitis suppurativa.

BackgroundMethotrexate is an immunomodulatory therapy that may offer benefit to patients with hidradenitis suppurativa (HS). Despite its theoretical advantages, there is a paucity of available data regarding long-term methotrexate use in patients with HS.ObjectiveThis study aimed to assess whether methotrexate treatment leads to improvement in HS disease severity.MethodsWe conducted an institutional review board–approved, single-center, retrospective chart review of patients with HS who were treated with methotrexate between 2000 and 2018. Primary outcome measurements included the HS Physician's Global Assessment (HS PGA), Hurley staging, abscess count, fistula count, and inflammatory nodule count.ResultsA total of 29 patients were identified; 14 were excluded for reasons including never starting methotrexate and missing follow-up data. For remaining patients (n = 15), the average cumulative dose of methotrexate was 520.1 mg (range, 30–1665 mg) and the average length of treatment was 11.7 months (range, 1–38 months). Patients taking methotrexate as a primary therapy had a higher cumulative dose and length of treatment (520.13 mg; 14.6 months) compared with those taking biologics concomitantly (468.44 mg; 9.1 months). Patients using methotrexate as primary therapy demonstrated nonsignificant reductions in HS PGA, inflammatory nodule count, and abscess count. Patients on concomitant biologic therapy failed to demonstrate any change in HS PGA, inflammatory nodule count, and abscess count.LimitationsLimitations of the study include its retrospective nature, small sample size, length of time on methotrexate between groups, and homogeneity of the patient population.ConclusionMethotrexate may represent an effective treatment option in older patients with lower body mass indices but fails to offer benefit in patients taking concurrent biologic therapy.

437 Peroral Endoscopic Myotomy Is a Safe and Effective Treatment Modality for Geriatric Patients With Achalasia

INTRODUCTION: Peroral endoscopic myotomy (POEM) is an emerging treatment modality for achalasia. It is a particularly appealing treatment option in older patients, as it is minimally invasive like an endoscopic procedure and highly effective as surgical myotomy. However, there is lack of a systematic study analyzing and comparing POEM outcomes in young (&lt; 65 years) and geriatric patients (≥65 years). Hence, our study aims were to assess and compare the safety and efficacy of POEM in young versus geriatric patients. METHODS: Medical records of all achalasia patients who underwent POEM at our institution between April 2014 and May 2019 were reviewed. Patients who underwent timed barium esophagram (TBE) and high-resolution manometry (HREM) prior to POEM along with two-month post-POEM esophageal pH study, TBE and HREM were included. Patients were categorized into two groups as: young (&lt;65 years) and old (≥65 years). Demographic and procedural details, TBE, HREM, pH study findings and Eckardt scores were compared between the two groups. Post-POEM Eckhardt score of ≤3 was considered as successful palliation of symptoms. RESULTS: 148 patients met the study criteria (&lt;65 years = 93; ≥65 years = 55). Younger patients were more likely to have higher BMI, but fewer comorbidities and lower TBE height at 1 minute but wider TBE width at 5 minutes. Rest of the TBE parameters, pre-operative Eckardt's score and lower esophageal sphincter-integrated relaxation pressure (LES-IRP) were similar between the two groups. Young patients were more likely to have undergone prior Heller myotomy, where as Botox injections were more common in older group. The operative time, total myotomy length, complications, length of stay and 30-day readmission rates were similar in the two groups (Table 1). POEM was successful in 94.5% young and 96% old patients. At two-month follow up, both groups showed significant improvements in Eckhardt scores (Figure 1a) and HREM parameters, however older patients showed greater improvement in TBE height at 1 and 5 minutes (Figure 1b,c). The rates of symptomatic GERD and abnormal esophageal pH study findings were not significantly different between the two groups (Table 2). CONCLUSION: POEM is a safe and effective treatment option for geriatric patients with achalasia similar to younger patients. POEM might emerge as the preferred approach for myotomy in this patient population, because of its low morbidity compared to surgical myotomy.

Safety and efficacy of a self-expanding versus a balloon-expandable bioprosthesis for transcatheter aortic valve replacement in patients with symptomatic severe aortic stenosis: a randomised non-inferiority trial

Transcatheter aortic valve replacement (TAVR) is the preferred treatment option for older patients with symptomatic severe aortic stenosis. Differences in the properties of available TAVR systems can affect clinical outcomes. Among patients undergoing TAVR, we compared the self-expanding ACURATE neo TAVR system with the balloon-expandable SAPIEN 3 TAVR system with regard to early safety and efficacy. In this randomised non-inferiority trial, patients (aged ≥75 years) undergoing transfemoral TAVR for treatment of symptomatic severe aortic stenosis, and who were deemed to be at increased surgical risk, were recruited at 20 tertiary heart valve centres in Germany, the Netherlands, Switzerland, and the UK. Participants were randomly assigned (1:1) to receive treatment with the ACURATE neo or the SAPIEN 3 with a computer-based randomly permuted block scheme, stratified by study centre and Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) category. The primary composite safety and efficacy endpoint comprised all-cause death, any stroke, life-threatening or disabling bleeding, major vascular complications, coronary artery obstruction requiring intervention, acute kidney injury (stage 2 or 3), rehospitalisation for valve-related symptoms or congestive heart failure, valve-related dysfunction requiring repeat procedure, moderate or severe prosthetic valve regurgitation, or prosthetic valve stenosis within 30 days of the procedure. Endpoint assessors were masked to treatment allocation. Non-inferiority of ACURATE neo compared with SAPIEN 3 was assessed in the intention-to-treat population on the basis of a risk-difference margin of 7·7% for the primary composite endpoint, with a one-sided α of 0·05. This trial is registered with ClinicalTrials.gov (number NCT03011346) and is ongoing but not recruiting. Between Feb 8, 2017, and Feb 2, 2019, up to 5132 patients were screened and 739 (mean age 82·8 years [SD 4·1]; median STS-PROM score 3·5% [IQR 2·6-5·0]) were enrolled. 30-day follow-up was available for 367 (99%) of 372 patients allocated to the ACURATE neo group, and 364 (99%) of 367 allocated to the SAPIEN 3 group. Within 30 days, the primary endpoint occurred in 87 (24%) patients in the ACURATE neo and in 60 (16%) in the SAPIEN 3 group; thus, non-inferiority of the ACURATE neo was not met (absolute risk difference 7·1% [upper 95% confidence limit 12·0%], p=0·42). Secondary analysis of the primary endpoint suggested superiority of the SAPIEN 3 device over the ACURATE neo device (95% CI for risk difference -1·3 to -12·9, p=0·0156). The ACURATE neo and SAPIEN 3 groups did not differ in incidence of all-cause death (nine patients [2%] vs three [1%]) and stroke (seven [2%] vs 11 [3%]); whereas acute kidney injury (11 [3%] vs three [1%]) and moderate or severe prosthetic aortic regurgitation (34 [9%] vs ten [3%]) were more common in the ACURATE neo group. TAVR with the self-expanding ACURATE neo did not meet non-inferiority compared to the balloon-expandable SAPIEN 3 device in terms of early safety and clinical efficacy outcomes. An early composite safety and efficacy endpoint was useful in discriminating the performance of different TAVR systems. Boston Scientific (USA).

Non-Melanoma Skin Cancers in the Older Patient.

The incidence of non-melanomatous skin cancer (NMSC) increases with age and there are specific considerations regarding management of NMSC for the older patient population. Here we will review current data regarding treatment considerations and options for older patients with NMSC. Hypofractionated regimens and high-dose brachytherapy may be non-surgical treatment options for older patients with NMSC. Other less aggressive strategies such as active surveillance can also be considered in some settings. Management of NMSC in the older patient population requires a thorough assessment of comorbidities, frailty, and life expectancy. Additionally, discussions regarding goals of care and quality of life (QOL) issues are especially important in this population. Older patients with NMSC in particular may benefit from a tailored treatment plan based on current available data rather than a broad application of general treatment guidelines for NMSC.

Prognostic significance of pretreatment neutrophil-to-lymphocyte ratio in older patients with metastatic cancer.

Treatment options for older patients with malignancies remain suboptimal. An accurate prognostic stratification could inform treatment decisions, which can potentially improve patient outcomes. Here, we sought to investigate whether the neutrophil-to-lymphocyte ratio (NLR) may have prognostic significance in patients with metastatic malignant tumors, with a special focus on older individuals. We retrospectively reviewed the clinical records of 3981 patients with histology-proven metastatic cancer who underwent radiotherapy between 2000 and 2013. The pretreatment NLR was determined within 7 days before treatment initiation. Patients aged ≥65 years were considered as older. We analyzed the prognostic significance of NLR for overall survival (OS) across all age groups. Compared with their younger counterparts, older patients showed a higher NLR (P < 0.001) and a lower OS (P < 0.001). Multivariate analysis revealed that a pretreatment NLR below the median was an independent favorable predictor of OS in both older (hazard ratio [HR]: 0.669, 95.0% CI: 0.605-0.740; P < 0.001) and younger patients (HR: 0.704; 95.0% CI: 0.648-0.765; P < 0.001). Regardless of age, patients who underwent systemic therapy showed more favorable OS, especially when NLR was low. In the older subgroup, the OS of patients with a low pretreatment NLR who did not undergo systemic therapy and of those with high pretreatment NLR who underwent systemic therapy was similar. A low pretreatment NLR predicts a more favorable OS in older patients with metastatic cancer. The most favorable OS was observed in patients with a low pretreatment NLR who received systemic therapy.

Clinical and radiographic outcomes of open Latarjet procedure in patients aged 40 years or older

The Latarjet procedure is often used to treat shoulder instability in younger patients. Little is reported on the outcomes of this procedure in older (≥40 years) populations. The purpose of this study was to evaluate the clinical and radiographic outcomes of patients aged 40 years or older with recurrent anterior shoulder instability who underwent open Latarjet stabilization. A total of 168 patients aged 40 years or older were treated surgically for recurrent anterior shoulder instability with an open Latarjet procedure between 1988 and 2014. Bankart lesions or anteroinferior glenoid fractures were confirmed preoperatively with a computed tomography arthrogram. Outcomes were assessed with preoperative and postoperative physical examinations, clinical outcome scoring, and radiographic examinations. Ninety-nine patients with complete data were available with a mean follow-up period of 13 years (range, 3-23 years). At the time of final follow-up, 94% of patients did not have recurrence of instability. Of the patients, 90% were satisfied or very satisfied with their outcomes and 54% returned to their preinjury level of activity. The overall complication rate was 21% (the most common complications being subjective apprehension [9%] and recurrent instability [6%]), with 9% of patients requiring reoperation. A full-thickness rotator cuff requiring repair was identified in 22% of patients. The Latarjet procedure is an effective treatment option for older patients (aged ≥ 40 years) with recurrent anterior shoulder instability in the setting of an anteroinferior capsulolabral and/or bony injury.

New FDA Approved Therapies for AML &amp; Impact on the Older Population

New FDA Approved Therapies for AML &amp; Impact on the Older Population