Goal Of Palliation Research Articles

Differences in the palliative care phase between patients with nonmalignant pulmonary disease and lung cancer: a retrospective study

BackgroundPatients with chronic nonmalignant pulmonary disease and lung cancer both need palliative care, but palliative care services may be better adjusted to serve cancer patients. We compared the timing and clinical practice of palliative care and acute hospital usage during the last year of life in patients with nonmalignant pulmonary disease or lung cancer.MethodsThis was a retrospective study of all patients in a palliative care phase (palliative goal of care) with nonmalignant pulmonary disease or lung cancer who were treated at Tampere University Hospital, Finland, during the years 2018–2020. The data were collected from the hospital’s medical records. Comparisons between the groups were performed by using the Pearson chi-square test, Fisher’s exact test, or Mann‒Whitney U test when appropriate. Survival was estimated by using the Kaplan‒Meier method.ResultsThe study population consisted of 107 patients with nonmalignant pulmonary disease and 429 patients with lung cancer. Patients with nonmalignant pulmonary disease survived longer in the palliative care phase than patients with lung cancer (115 vs. 59 days, p < 0.001). Compared to lung cancer patients, patients with nonmalignant disease received a palliative care specialist consultation more often during hospitalization (66% vs. 45%, p < 0.001) than during a preplanned outpatient visit (6% vs. 52%, p < 0.001), were less likely to be referred to palliative care pathway (79% vs. 87%, p = 0.033), and spent more days in an acute care hospital during the last year of life (median of 10 vs. 6 days, p = 0.023). Contrary to lung cancer patients, referral to the palliative care pathway was not significantly associated with decreased acute hospital resource usage during the last month of life among patients with nonmalignant pulmonary disease.ConclusionsCompared to lung cancer patients, patients with nonmalignant pulmonary disease had longer palliative care phases but fewer visits to the palliative care outpatient clinic and fewer referrals to the palliative care pathways. Palliative care arrangements seemed to have more influence on the end-of-life care of lung cancer patients. There is a need for long-term palliative care services with better abilities to meet the special needs of patients with nonmalignant pulmonary disease.

The life threat in hematopoietic allogeneic stem cell transplantation - an interview and focus group study on health care professionals' perspectives.

Understanding healthcare professionals' (HCPs) experiences with patients undergoing hematopoietic allogeneic stem cell transplantation (allo-HSCT) is crucial, given its dual nature of offering a hope for cure which on the other hand is accompanied by a high risk for morbidity and mortality. Yet, how HCPs experience their patients' existential threats remains unexplored. Qualitative thematic content analysis was employed to comprehend these experiences. This involved conducting three focus groups and 11 individual in-depth interviews with nurses and hematologists. We found that HCPs struggled to balance curative goals and the therapy's risks, while attempting to maintain their patients' hopes. The unpredictability of patient trajectories and their suffering burdened HCPs. Despite occasional disagreements within the team, (inter-)professional exchanges remained a crucial ressource, especially in addressing the patients' potential life threat. Team meetings and palliative care specialist supervisions were emphasized as vital for managing these challenges. HCPs sought support in communicating with patients about death-related issues and managing the transition from a curative to a palliative goal of care. Our research underscores the need for targeted support for HCPs and lays a groundwork for addressing their challenges. Trial registration number DRKS00027290 (German Clinical Trials Register). Date of trial registration January 10th, 2022.

Factors influencing parents' choice of palliative treatment goals for children with relapsed or refractory neuroblastoma: A multi-site longitudinal survey study.

Many parents of children with advanced cancer report curative goals and continue intensive therapies that can compound symptoms and suffering. Factors that influence parents to choose palliation as the primary treatment goal are not well understood. The objective of this study was to examine experiences impacting parents' report of palliative goals adjusted for time. The authors hypothesized that awareness of poor prognosis, recall of oncologists' prognostic disclosure, intensive treatments, and burdensome symptoms and suffering would influence palliative goal-setting. The authors collected prospective, longitudinal surveys from parents of children with relapsed/refractory neuroblastoma at nine pediatric cancer centers across the United States, beginning at relapse and continuing every 3months for 18months or until death. Hypothesized covariates were examined for possible associations with parental report of palliative goals. Generalized linear mixed models were used to evaluate factors associated with parents' report of palliative goals at different time points. A total of 96 parents completed surveys. Parents were more likely to report a primary goal of palliation when they recalled communication about prognosis by their child's oncologist (odds ratio [OR], 52.48; p = .010). Treatment intensity and previous ineffective therapeutic regimens were not associated with parents' report of palliative goals adjusted for time. A parent who reported new suffering for their child was less likely to report palliative goals (OR, 0.13; p = .008). Parents of children with poor prognosis cancer may not report palliative goals spontaneously in the setting of treatment-related suffering. Prognostic communication, however, does influence palliative goal-setting. Evidence-based interventions are needed to encourage timely, person-centered prognostic disclosure in the setting of advanced pediatric cancer. Many parents of children with poor-prognosis cancer continue to pursue curative treatments that may worsen symptoms and suffering. Little is known about which factors influence parents to choose palliative care as their child's main treatment goal. To explore this question, we asked parents of children with advanced neuroblastoma across the United States to complete multiple surveys over time. We found that the intensity of treatment, number of treatments, and suffering from treatment did not influence parents to choose palliative goals. However, when parents remembered their child's oncologist talking about prognosis, they were more likely to choose palliative goals of care.

Safety and Efficacy of Spatially Fractionated Radiation Therapy Using Lattice Radiation for Metastatic and/or Bulky Disease

Spatially fractionated radiation therapy (Lattice) delivers ablative doses to metastatic and/or unresectable tumors with a curative or palliative goal. Through different forms of three-dimensional focusing, lattice forms several spherical high-dose areas(vertices) within the tumor, to produce a more obvious peak-valley effect and limit exposure to surrounding normal tissue. This study aimed to evaluate the efficacy and toxicity of patients with metastatic and/or bulky tumors treated with Lattice radiation. Between April 2017 and February 2021, 76 patients with metastatic or bulky tumors treated with spatially-fractionated high-dose external beam radiation using the Lattice technique were included. A median dose of 15 Gy/1 fraction (range 10-45 Gy in 1/3 fractions) was delivered to the vertices in the gross tumor volumes (GTV). 46 patients were treated with Lattice radiation combined with conventional fractionated external irradiation, and 30 patients were treated with Lattice alone. Patients were evaluated for clinical response, survival, and toxicity. A total of 76 patients with 85 sites were included in the analysis, 63 (82.9%) patients had metastatic diseases. Median GTV was 138.6cc (range 4.9-3784.1cc) in volume and 6.2 cm (range:2.3-21.4cm) in greatest axial diameter. 38 tumors were in the thorax, 13 abdomen/pelvis, 19 metastatic lymph nodes, 8 bone, 5 head and neck, and 2 extremities. The median follow-up was 11.6 months (range 1.27-57.37 months). At the time of analysis, 23 patients (29.9%) were alive, without the progression of disease. 90.7% of the deceased patients died of disease progression. Median overall survival (OS) was 11.4 months (95% CI: 8.4-17.6), the 1-year OS and cancer specific survival were 46.8% and 48.7% respectively. The disease control rate (DCR) was 91.8%, including 2.4% complete remission, 48.2% partial remission, and 41.2% stable disease. Symptomatic improvement was observed in 98.7% of patients. No mortality was associated with Lattice therapy. There was no treatment-associated acute or late grade 3+ toxicity. Lattice radiation is feasible and well-tolerated in the treatment of metastatic and/or bulky diseases, and may provide a high DCR. In light of these preliminary results, it seems that this therapy may be a new paradigm for treating patients with advanced cancers.

Specialist Palliative Care Consultation for Patients with Nonmalignant Pulmonary Diseases: A Retrospective Study.

Few patients with chronic nonmalignant pulmonary diseases receive specialist palliative care consultation, despite their high symptom burden in end of life. To study palliative care decision making, survival, and hospital resource usage in patients with nonmalignant pulmonary diseases with or without a specialist palliative care consultation. A retrospective chart review of all patients with a chronic nonmalignant pulmonary disease and a palliative care decision (palliative goal of therapy), who were treated in Tampere University Hospital, Finland, between January 1, 2018 and December 31, 2020. A total of 107 patients were included in the study, 62 (58%) had chronic obstructive pulmonary disease (COPD), and 43 (40%) interstitial lung disease (ILD). Median survival after palliative care decision was shorter in patients with ILD than in patients with COPD (59 vs. 213 days, p = 0.004). Involvement of a palliative care specialist in the decision making was not associated with the survival. Patients with COPD who received palliative care consultation visited less often emergency room (73% vs. 100%, p = 0.019) and spent fewer days in the hospital (7 vs. 18 days, p = 0.007) during the last year of life. When a palliative care specialist attended the decision making, the presence and opinions of the patients were recorded more often, and the patients were more frequently referred to a palliative care pathway. Specialist palliative care consultation seems to enable better end-of-life care and supports shared decision making for patients with nonmalignant pulmonary diseases. Therefore, palliative care consultations should be utilized in nonmalignant pulmonary diseases preferably before the last days of life.

Preoperative Workup, Staging, and Treatment Planning of Colorectal Cancer

AbstractColorectal cancer (CRC) remains a leading cause of death in the United States. CRC is the second to third most common cancer globally and it impacts both genders. Screening initiatives are of paramount importance to eradicate the disease at a precancerous or early stage. Recommendations for screening are based on multiple factors including age, ethnicity, individual patient risk factors, and family history. Short- and long-term outcomes and survival data correlate with the stage of disease at the time of diagnosis emphasizing the need for appropriate baseline staging. Furthermore, stage of disease determines the necessity for any neoadjuvant or adjuvant therapy and provides recommendations for long-term oncologic follow-up. Preoperative workup includes physical examination, blood tests such as tumor markers and liver function tests, endoscopic evaluation, and cross-sectional imaging. In a select group of patients, genetic testing is part of the initial evaluation as it can impact the treatment plan, long-term follow-up, and testing of potential offspring. In general, surgical intervention remains the predominant treatment modality for stage I to III colon cancers with chemotherapy administration as adjuvant therapy for stages II to III to minimize recurrence or as a palliative modality for patients with stage IV disease. The treatment of rectal cancer remains more complex. Traditionally, early rectal cancer has been treated with surgical resection and locally advanced rectal cancer with neoadjuvant chemoradiation followed by surgical resection and postoperative chemotherapy. In the last decade, several protocols have been implemented to modify the neoadjuvant treatment with a trend toward more extended chemotherapy with the intent to further downstage the rectal cancer. Furthermore, the introduction of various protocols of total neoadjuvant chemoradiation may offer in a select group of patients with complete pathologic response, the possibility of observation without surgery. Finally, the management of stage IV CRC is in continuous evolution with the palliative goal of prolonging survival in most patients while offering the opportunity in some patients with limited metastatic disease to become potential candidates for resection of the primary lesion in addition to the metastatic disease.

Chronic Proliferative Osteoarthritis in the Horse - A Case Report

Chronic osteoarthritis of the pastern joint has a significant role in affecting the musculoskeletal system and is a recurrent cause of lameness in the equine athlete manifested by chronic lameness and thorough clinical and radiographic examination. This case report describes the evolution of chronic proliferative ossified osteoarthritis and periarthritis of the proximal interphalangeal joint of the front limb of a 12-year-old gelding. The careful clinical examination aimed to detect the site of the lesion, which is then confirmed by radiography that revealed extensive periarticular new bone formation over the proximal interphalangeal joint. This affection causes progressive deterioration of articular cartilage, accompanied by bone and soft-tissue periarticular changes. Control radiographic examination after a period of 10 months showed the extension of the lesion and the severe appearance of bone evolution and several medical approaches have been undertaken without improvement of the clinical condition of the horse. Several medical therapies are used in synergy with the palliative goal of reducing lameness and relieving pain, but most are of limited duration and do not stop the negative progression of the disease process. Once joint damage is advanced, it is difficult to remedy.

85. The neurology stability epidural compression assessment: a new score to establish the need for surgery in spinal metastases

85. The neurology stability epidural compression assessment: a new score to establish the need for surgery in spinal metastases

Palliative Care Dentistry: A Review

The palliative team gives warmth of life to the terminally ill patient and takes his/her care in order to maintain their well-being. The oncologists come across various hurdles while treating the problems of oral cavity in such patients. A trained dental professional can give a helping hand in such situations. However, general dental surgeon has minimal amount of knowledge regarding his responsibilities in these treatments. Even, the society is unaware about the potential benefits of a dentist in this area. Adequate learning programs should be included in the undergraduate curriculum and should be educated regarding the same. This review article suggests the forgetting responsibilities of an oral practitioner in palliation and discussing about various goals of palliation and about oral complications in terminally ill patients as well.

Burden and Needs of Patients with Severe GvHD from the Supportive and Palliative Care Perspective-A Literature Review.

Simple SummaryPatients who have been treated with an allogeneic, hematopoietic stem cell transplantation can develop severe graft-versus-host disease. This complication may place patients in a life-threatening situation, in which a curative goal of care can no longer be achieved and needs to be changed into a palliative one. In our clinical experience, this patient group is very heterogenous, with a high disease burden and special needs that are often overlooked. In this review, we summarize the current literature on the needs and burdens of patients with severe forms of graft-versus-host disease from a supportive and palliative care perspective to draw a comprehensive picture of this patient group. Despite a fundamental lack of studies, the findings suggest that the more severe the GvHD, the worse the quality of life and physical functioning. The relative void of data highlights the need for research on this special issue in order to optimize the treatment and care of patients with severe graft-versus-host disease.Graft-versus-host disease (GvHD) is a frequent, and often life-threatening, complication after an allogeneic, hematopoietic stem cell transplantation (allo-SCT). It can appear in an acute or a chronic form and presents different grades of severity. Particularly, the severe forms of GvHD are often responsible for a change of the curative intent for allo-SCT into a palliative goal of care. For this non-systematic review, we conducted a focused literature search in the MEDLINE database via PubMed to examine whether patients with severe forms of GvHD might have special needs and burdens from a supportive and palliative care perspective. To draw a comprehensive picture of this patient group, we included findings on quality of life (QoL) and physical symptoms and function as well as psychological and spiritual well-being. In most domains, patients with severe forms of GvHD showed greater impairment and a higher symptom burden compared to patients with milder forms of GvHD. However, we could not identify any studies that specifically investigated patients with severe forms of GvHD. Further research in this field is necessary to guarantee the highest standard of care for this very special patient group.

The impact of the duration of the palliative care period on cancer patients with regard to the use of hospital services and the place of death: a retrospective cohort study

BackgroundIn order to avoid unnecessary use of hospital services at the end-of-life, palliative care should be initiated early enough in order to have sufficient time to initiate and carry out good quality advance care planning (ACP). This single center study assesses the impact of the PC decision and its timing on the use of hospital services at EOL and the place of death.MethodsA randomly chosen cohort of 992 cancer patients treated in a tertiary hospital between Jan 2013 –Dec 2014, who were deceased by the end of 2014, were selected from the total number of 2737 identified from the hospital database. The PC decision (the decision to terminate life-prolonging anticancer treatments and focus on symptom centered palliative care) and use of PC unit services were studied in relation to emergency department (ED) visits, hospital inpatient days and place of death.ResultsA PC decision was defined for 82% of the patients and 37% visited a PC unit. The earlier the PC decision was made, the more often patients had an appointment at the PC unit (> 180 days prior to death 72% and < 14 days 10%). The number of ED visits and inpatient days were highest for patients with no PC decision and lowest for patients with both a PC decision and an PC unit appointment (60 days before death ED visits 1.3 vs 0.8 and inpatient days 9.9 vs 2.9 respectively, p < 0.01). Patients with no PC decision died more often in secondary/tertiary hospitals (28% vs. 19% with a PC decision, and 6% with a decision and an appointment to a PC unit).ConclusionsThe PC decision to initiate a palliative goal for the treatment had a distinct impact on the use of hospital services at the EOL. Contact with a PC unit further increased the likelihood of EOL care at primary care.

SPIRITUAL PASIEN PALIATIF DI RUMAH SAKIT, YOGYAKARTA SPIRITUALITY OF PALLIATIVE PATIENT IN HOSPITAL, YOGYAKARTA Milatul

Background: Palliative care goal is to improve the quality of life of the patient. Spiritual is believed can improve the quality of life in palliative patients.&#x0D; Objective: The purpose of this research is to identify the spiritual status of palliative patients in PKU Muhammadiyah Gamping Yogyakarta Hospital.&#x0D; Methods: This study is a non-experiment research. It used descriptive survey research method with 100 subjects which used total sampling technique. FACIT-Sp is choosen based on this validity(r=0,5) dan realibity (r=0,768) to get the spiritual status of the sample.&#x0D; Results: The result of univariate analysis showed that the spiritual level of palliative patients in PKU Muhammadiyah Gamping Hospital with the mean values of 36,79 (0-48) and the spiritual component consisted of mean is 12,26 (0-16), faith is 12,85 (0-16) and peace 68 (0-16).&#x0D; Conclusion: The spiritual status of palliative patients at Muhammadiyah Gamping Yogyakarta Hospital in the categories of meaning, faith, peace and spiritual level most have passed the cut of point, it showed that the palliative patient is headed to the good spiritual.&#x0D; Keyword : Palliative care, spiritual, mean, faith, peace

Assessing the utilization of the decision to implement a palliative goal for the treatment of cancer patients during the last year of life at Helsinki University Hospital: a historic cohort study

Background: To avoid aggressive treatments at the end-of-life and to provide palliative care (PC), physicians need to terminate futile anti-cancer treatments and define the palliative goal of the treatment in time. This single center study assesses the practices used to make the decision that leads to treatment with a palliative goal, i.e., the PC decision and its effect on anti-cancer treatments at the end of life.Material and methods: Patients with a cancer diagnosis treated in tertiary hospital during 1st January 2013 – 31st December 2014 and deceased by the end of 2014 were identified in the hospital database (N = 2737). Of these patients, 992 were randomly selected for this study. The PC decision was screened from patient records, i.e., termination of cancer-specific treatments and a focus on symptom-centered PC.Results: The PC decision was defined in 82% of the patients during the last year of life (49% >30 days and 33% ≤30 days before death, 18% with no decision). The median time from the decision to death was 46 days. Systemic cancer therapy was given during the last month of life in 1%, 36% and 38% (p < .001) and radiotherapy 22%, 40% and 31% (p = .03) cases, respectively; referral to a PC unit was made in 62%, 22% and 11%, respectively (p < .001). In logistic regression analyses younger age, shorter duration of the disease trajectory and type of cancer (e.g., breast cancer) were associated with a lack or late timing of the PC decision.Conclusion: The decision to initiate a palliative goal for the treatment was frequently made for cancer patients but occurred late for every third patient. Younger age and certain cancer types were associated with late PC decisions, thus leading to anti-cancer treatments continuing until close to the death with low access to a PC unit.

SPIRITUAL PASIEN PALIATIF DI RUMAH SAKIT, YOGYAKARTA

Background: Palliative care goal is to improve the quality of life of the patient. Spiritual is believed can improve the quality of life in palliative patients.&#x0D; Objective: The purpose of this research is to identify the spiritual status of palliative patients in PKU Muhammadiyah Gamping Yogyakarta Hospital.&#x0D; Methods: This study is a non-experiment research. It used descriptive survey research method with 100 subjects which used total sampling technique. FACIT-Sp is choosen based on this validity(r=0,5) dan realibity (r=0,768) to get the spiritual status of the sample.&#x0D; Results: The result of univariate analysis showed that the spiritual level of palliative patients in PKU Muhammadiyah Gamping Hospital with the mean values of 36,79 (0-48) and the spiritual component consisted of mean is 12,26 (0-16), faith is 12,85 (0-16) and peace 68 (0-16).&#x0D; Conclusion: The spiritual status of palliative patients at Muhammadiyah Gamping Yogyakarta Hospital in the categories of meaning, faith, peace and spiritual level most have passed the cut of point, it showed that the palliative patient is headed to the good spiritual.&#x0D; &#x0D; Keyword : Palliative care, spiritual, mean, faith, peace

Malignant Pleural Effusion: Still a Long Way to Go.

Malignant pleural effusion, which is a common clinical problem in patients with cancer, may be due to both primary thoracic tumours or to a metastatic spread in the chest and constitutes the first sign of disease in approximately 10% of patients. Almost all cancers can potentially produce a pleural effusion. The presence of malignant tumour cells in the pleural fluid is generally indicative of advanced disease and is associated with high morbidity and mortality with reduced therapeutic options. Dyspnoea during mild physical activity or at rest is generally the typical sign of restrictive respiratory failure. This is a systematic review of all the main articles in the English language on the topic of malignant pleural effusion and reported by the Pubmed database from 1959 to 2018. I reviewed the literature and guidelines with the aims to focus on what is known and on future pathways to follow the diagnosis and treatment of malignant pleural effusions. The main goal of palliation of a malignant pleural effusion is a quick improvement in dyspnoea, while thoracentesis under ultrasound guidance is the treatment of choice for patients with a limited life expectancy or who are not candidates for more invasive procedures such as drainage using an indwelling small pleural catheter, chemical pleurodesis with sclerosing agents, pleurectomy or pleuro-peritoneal shunt. Despite progress in therapeutic options, the prognosis remains severe, and the average survival is 4-9 months from the diagnosis of malignant pleural effusion. Moreover, mortality is higher for patients with malignant pleural effusion compared with those with metastatic cancer but no malignant pleural effusion. Therefore, the prognosis of these patients primarily depends on the underlying disease and the extension of a primary tumour. This review focuses on the most relevant updates in the management of malignant pleural effusion.

Radiotherapy plus hyperthermia is effective for painful bony metastases—optimal schedule unsettled

We thank van Rhoon and van Holthe for their interests and comments on our article of combined hyperthermia (HT) and radiation therapy (RT) for painful bony metastases (1). In our study, a significant pain improvement and duration of response was demonstrated by HT + RT. We emphasized the complete response (CR) rate at the third month than the accumulated CR rate within 3 months, because the palliative goal for the good performance patients should focus more on long-lasting response (2). Our analysis was indeed limited by small patient size (58 patients). However, timing of preset analysis and the rule of early termination were performed according to protocol and were mandated by the institutional review board and health regulatory authorities for clinical trials.

Hodgkin lymphoma in elderly patients.

We aim to summarize the current knowledge on the treatment of elderly Hodgkin lymphoma patients with a focus on evidence from clinical trials and novel drugs. For elderly Hodgkin lymphoma patients above 60 years without precluding comorbidities a curative treatment approach is warranted. Early favorable stage patients should receive two cycles of multiagent chemotherapy followed by 20 Gy localized radiotherapy. Early unfavorable stage patients should receive four cycles of multiagent chemotherapy followed by 30 Gy localized radiotherapy. For advanced stage patients six cycles of multiagent chemotherapy can be recommended and should be followed by localized radiotherapy on residual disease manifestations. Relapsed or refractory patients should be treated in an individually tailored approach that considers both the patient's objectives and comorbidities. The antibody-drug conjugate brentuximab vedotin is a very effective option for elderly patients with a high response rate albeit limited durability. Anti-programed cell death protein 1 antibodies might also be effective in elderly Hodgkin lymphoma patients with a mechanism of action distinct from chemotherapy. In conclusion, the goal of treatment in newly diagnosed elderly Hodgkin lymphoma patients is curative whenever possible and prospective and retrospective evidence has shown that this is feasible for all disease stages with a variety of multiagent chemotherapy regimen. Relapsed and refractory elderly Hodgkin lymphoma patients can mostly only be treated with the goal of palliation. However, it remains to be seen if novel substances and new combination regimen are able to change that.

MS 14.01 Elements to Reach the Treatment Goal of Palliation

Despite fast growing information of tumor molecular biology, the increase in the therapeutic portfolio, and a significant improvement in diagnostic radiology, treatment of advanced NSCLC in 2017 remains palliative with still no curative perspective for the vast majority of patients. Therefore, the main treatment goals include the change from an acute into a chronic disease, extending survival times as well as improving or just maintaining quality of life. In order to assure an optimal palliation the majority of patients with advanced NSCLC – considering the high age and concomitant comorbidities - frequently may require modifications of the treatment standard.

Impact of Frailty on Outcomes in Patients Undergoing Percutaneous Mitral Valve Repair

ObjectivesThe aim of this study was to describe the impact of frailty in patients undergoing percutaneous mitral valve repair (PMVR). BackgroundFrailty is common in elderly patients and those with comorbidities and is associated with adverse prognosis. MethodsFrailty according to the Fried criteria was assessed in consecutive patients admitted for PMVR. Associations of frailty with 6-week (device success, changes in 6-min walking distance and Minnesota Living With Heart Failure Questionnaire and Short Form 36 physical and mental component scores, and improvement ≥1 New York Heart Association functional class) and long-term outcomes during a median follow-up period of 429 days were examined. ResultsOf 213 patients admitted for PMVR (median age 78 years; age range 50 to 95 years; 57.3% men), 45.5% were classified as frail. Compared with nonfrail patients, frail patients had a similar device success rate (81.4% vs. 84.5%; p = 0.56) and improvement in 6-min walking distance, New York Heart Association functional class, and Short Form-36 scores but a more pronounced improvement in Minnesota Living With Heart Failure Questionnaire score (mean change −15.9 vs. −11.2 points; p = 0.002). Mortality at 6 weeks was significantly higher in frail (8.3%) compared with nonfrail (1.7%) patients (p = 0.03). Hazards of death (hazard ratio: 3.06; 95% confidence interval: 1.54 to 6.07; p = 0.001) and death or heart failure decompensation (hazard ratio: 2.03; 95% confidence interval: 1.22 to 3.39; p = 0.007) were significantly increased in frail patients during long-term follow-up, which did not change relevantly after adjustment for European System for Cardiac Operative Risk Evaluation score and N-terminal pro–brain natriuretic peptide level. ConclusionsPMVR can be performed with equal efficacy and is associated with at least similar short-term functional improvement in frail patients. These results support the continued use of PMVR in frail elderly patients with the goal of palliation of heart failure symptoms and improvement in quality of life.

Phase I/II trial of combined kyphoplasty and intraoperative radiotherapy in spinal metastases

Background ContextSpinal metastases occur in 30%–50% of patients with systemic cancer. The primary goals of palliation are pain control and prevention of local recurrence. PurposeThis study aimed to test the safety and efficacy of a combined modality approach consisting of kyphoplasty and intraoperative radiotherapy (Kypho-IORT). Study Design/SettingKyphoplasty and intraoperative radiotherapy was a prospective, single-center phase I/II trial. Patients were enrolled in a classical 3+3 scheme within the initial phase I, where Kypho-IORT was applied using a needle-shaped 50 kV X-ray source at three radiation dose levels (8 Gy in 8-mm, 8 Gy in 11-mm, and 8 Gy in 13-mm depth). Thereafter, cohort expansion was performed as phase II of the trial. The trial is registered with clinicaltrials.gov, number NCT01280032. Patient SamplePatients aged 50 years and older with a Karnofsky Performance Status of at least 60% and with one to three painful vertebral metastases confined to the vertebral body were eligible to participate. Outcome MeasuresThe primary end point was safety as per the occurrence of dose-limiting toxicities. The secondary end points were pain reduction, local progression-free survival (L-PFS), and overall survival (OS). MethodsPain was measured using the visual analog scale (VAS) and local control was assessed in serial computed tomography or magnetic resonance imaging scans. ResultsNone of the nine patients enrolled in the phase I showed dose-limiting toxicities at any level and thus, 52 patients were subsequently enrolled into a phase II, where Kypho-IORT was performed at various dose levels. The median pain score significantly dropped from 5 preoperatively to 2 at the first postoperative day (p<.001). Of 43 patients who reported a pre-interventional pain level of 3 or more, 30 (69.8%) reported a reduction of ≥3 points on the first postoperative day. A persistent pain reduction beyond the first postoperative day of ≥3 points was seen in 34 (79.1%) patients. The 3, 6, and 12 month L-PFS was excellent with 97.5%, 93.8%, and 93.8%. The 3, 6, and 12 months OS was 76.9%, 64.0%, and 48.4%. ConclusionKyphoplasty and intraoperative radiotherapy is safe and immediately provided sustained pain relief with excellent local control rates in patients with painful vertebral metastases.