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1.
Clin Liver Dis (Hoboken) ; 23(1): e0110, 2024.
Article in English | MEDLINE | ID: mdl-38312994
2.
ACG Case Rep J ; 10(12): e01230, 2023 Dec.
Article in English | MEDLINE | ID: mdl-38130480

ABSTRACT

Corydalis is an herbal plant found in Asian countries. Research has demonstrated multiple health benefits. It has also been implicated in drug-induced liver injury. Cannabis dispensaries market a sleep aid which has corydalis as an active ingredient. We present 2 cases of corydalis-induced hepatotoxicity. An asymptomatic female patient exhibited a rise and fall of her transaminases coinciding with the consumption and rechallenge of this sleep aid. A man with symptoms consistent with liver dysfunction began taking the same sleep aid. With discontinuance, his liver function returned to normal. These 2 clinical cases provide evidence for corydalis-induced liver injury.

3.
Indian J Thorac Cardiovasc Surg ; 39(4): 412-416, 2023 Jul.
Article in English | MEDLINE | ID: mdl-37346443

ABSTRACT

Coronary stent infections (CSI) are rare but a potentially life-threatening disease, the incidence of which has been on a rise over the last two decades. We report the case of a patient who presented with episodes of fever and discharging sternal wound. The patient was diagnosed as CSI arising from the left anterior descending artery stent which was communicating anteriorly to the skin and posteriorly as lobar-fistula. He was treated by stent removal and plication of the fistula. Blood culture, culture of the pus and infected stent, and coronary angiography are the preferred diagnostic modalities, followed by positron emission tomography (PET) scan and cardiac magnetic resonance imaging (MRI) for delineating the extent of pathology. Surgery seems to be the treatment of choice, providing a definitive diagnosis of CSI and removing the source of infection, repairing aneurysms, and providing bypass vascular grafts if feasible. Thorough evaluation and a multidisciplinary approach with the institution of appropriate medical and surgical therapy lead to timely detection and good outcome.

4.
Braz J Cardiovasc Surg ; 38(1): 204-208, 2023 02 10.
Article in English | MEDLINE | ID: mdl-36897822

ABSTRACT

Primary cardiac hydatid cyst is a rare and fatal pathology, especially when involving the left ventricular free wall. A 44-year-old male was diagnosed with large intramural left ventricular hydatid cyst with wall thickness of 6 mm at the thinnest point. Cyst was accessed through pleuropericardial approach (left pleura opened, followed by entry into cyst directly through adjacent pericardium without removing the pericardial adhesions) which resulted in easy entry into the cyst, mitigating the risk of mechanical injury. This case report highlights that with detailed evaluation, cardiac hydatidosis can be addressed with off-pump technique, reducing the anaphylaxis risks and cardiopulmonary bypass-related effects.


Subject(s)
Cysts , Echinococcosis , Male , Humans , Adult , Pleura , Echinococcosis/surgery , Heart Ventricles/surgery , Pericardium
5.
Rev. bras. cir. cardiovasc ; 38(1): 204-208, Jan.-Feb. 2023. tab, graf
Article in English | LILACS-Express | LILACS | ID: biblio-1423070

ABSTRACT

ABSTRACT Primary cardiac hydatid cyst is a rare and fatal pathology, especially when involving the left ventricular free wall. A 44-year-old male was diagnosed with large intramural left ventricular hydatid cyst with wall thickness of 6 mm at the thinnest point. Cyst was accessed through pleuropericardial approach (left pleura opened, followed by entry into cyst directly through adjacent pericardium without removing the pericardial adhesions) which resulted in easy entry into the cyst, mitigating the risk of mechanical injury. This case report highlights that with detailed evaluation, cardiac hydatidosis can be addressed with off-pump technique, reducing the anaphylaxis risks and cardiopulmonary bypass-related effects.

6.
JACC Case Rep ; 28: 102117, 2023 Dec 20.
Article in English | MEDLINE | ID: mdl-38204552

ABSTRACT

Coronary stent infection (CSI) is a rare but potentially life-threatening disease, the incidence of which has been on a rise over the past 2 decades. Surgery seems the treatment of choice, providing a definitive diagnosis of CSI and removing the source of infection, repairing aneurysms, and providing bypass vascular grafts if feasible. Thorough evaluation and a multidisciplinary approach lead to detection and a better outcome. We report a patient who presented with symptoms of heart failure and shock, who received a diagnosis of CSI complicated by empyema with pleuropericardial fistula. He was treated by stent removal and decortication.

7.
Braz J Cardiovasc Surg ; 37(2): 273-276, 2022 05 02.
Article in English | MEDLINE | ID: mdl-35503701

ABSTRACT

Epicardial cysts are rarer benign tumors than pericardial cysts. There have been few reports on surgical management of epicardial cysts. A 17-year-old normotensive boy presented with chest pain and palpitations, which on evaluation was found to be a mediastinal mass (pericardial cyst). Surgical resection of the cyst via thoracotomy was planned. The cyst was diagnosed as an epicardial cyst intraoperatively. However, due to the epicardial origin of cyst and posterior adhesions, resection was done via midline approach. The base was formed by visceral pericardium and eroding into myocardium of left ventricle, so the resection was concluded with on-pump surgery. In case of erroneous diagnosis or undesirable finding, a safer midline approach with on-pump surgery, as an alternative to minimally invasive approach for complicated epicardial cysts (erosion into ventricle/lying in close proximity to important structures or near to coronary arteries) should be considered.


Subject(s)
Mediastinal Cyst , Adolescent , Chest Pain , Heart Ventricles/surgery , Humans , Male , Mediastinal Cyst/diagnostic imaging , Mediastinal Cyst/surgery , Pericardium/surgery , Thoracotomy
8.
Rev. bras. cir. cardiovasc ; 37(2): 273-276, Apr. 2022. tab, graf
Article in English | LILACS-Express | LILACS | ID: biblio-1376525

ABSTRACT

Abstract Epicardial cysts are rarer benign tumors than pericardial cysts. There have been few reports on surgical management of epicardial cysts. A 17-year-old normotensive boy presented with chest pain and palpitations, which on evaluation was found to be a mediastinal mass (pericardial cyst). Surgical resection of the cyst via thoracotomy was planned. The cyst was diagnosed as an epicardial cyst intraoperatively. However, due to the epicardial origin of cyst and posterior adhesions, resection was done via midline approach. The base was formed by visceral pericardium and eroding into myocardium of left ventricle, so the resection was concluded with on-pump surgery. In case of erroneous diagnosis or undesirable finding, a safer midline approach with on-pump surgery, as an alternative to minimally invasive approach for complicated epicardial cysts (erosion into ventricle/lying in close proximity to important structures or near to coronary arteries) should be considered.

9.
BJR Case Rep ; 7(6): 20210075, 2022 Mar.
Article in English | MEDLINE | ID: mdl-35300243

ABSTRACT

Hydroxyapatite crystal deposition disease (HADD) around the hip is typically described involving the gluteal tendons. However, HADD can occur in any location and result in varied clinical presentations. Even with small deposits, symptoms can be significant and imaging findings may appear aggressive, mimicking infection and malignancy particularly when in an atypical location. We illustrate cases of both common and rare locations of HADD around the hip, in particular presenting as greater trochanteric pain syndrome, piriformis syndrome and ischiofemoral impingement. The latter two manifestations have not been previously described in the literature. Low signal deposits were identified on MRI at the greater trochanter (gluteus medius tendon), proximal piriformis (adjacent to the sciatic nerve), and quadratus femoris (in the ischiofemoral space), respectively. Associated inflammatory changes with tendinopathy, bursitis and oedema were also demonstrated. The patient with piriformis syndrome underwent steroid injections and shockwave therapy with significant symptom improvement. HADD should be within the differential diagnosis for hip pain and nerve compression syndromes. Knowledge of tendon anatomy and correlation with radiographs or CT, even after MRI, is crucial in recognising unusual manifestations and preventing unnecessary investigation. Therefore, we review the spectrum of imaging features of HADD, as well as the current evidence on its management, to confidently diagnose this condition.

10.
Surg Radiol Anat ; 44(2): 273-277, 2022 Feb.
Article in English | MEDLINE | ID: mdl-34797402

ABSTRACT

Articular facet morphology plays a fundamental role in subtalar joint biomechanics and stability, and likely influences the development of hindfoot osteoarthritis. While multiple anatomical studies have shown wide variation in articular facet configuration, the clinico-radiological findings are rarely presented. We illustrate a case of bilateral subtalar joint middle facet agenesis in a 45-year-old woman, which was missed despite several presentations. We demonstrate the imaging findings to enable clinicians to distinguish this from the more common middle facet coalition. We summarise the developmental anatomy and discuss the potential implications on biomechanical function. Recognition of middle facet agenesis within the complex subtalar joint is important to prevent misdiagnosis and unnecessary surgery.


Subject(s)
Subtalar Joint , Female , Humans , Middle Aged , Subtalar Joint/diagnostic imaging
11.
Indian J Pharmacol ; 53(4): 264-269, 2021.
Article in English | MEDLINE | ID: mdl-34414903

ABSTRACT

BACKGROUND: Inappropriate sinus tachycardia (IST) is an arrhythmic complication observed after coronary artery bypass graft (CABG) surgery which left untreated, commonly increases chances of postoperative stroke. The primary study objective was comparing effectiveness of beta blocker-metoprolol; a specific If blocker-ivabradine and its combination in patients who develop IST as a complication following CABG. MATERIALS AND METHODS: An open-labeled, investigator initiated, clinical study was conducted on 150 patients who developed IST (heart rate [HR] >100 beats/min) following elective CABG surgery. The patients were randomized into three treatment groups. Group I - received ivabradine (5 mg), Group II - metoprolol (25 mg), and Group III - ivabradine (5 mg) and metoprolol (25 mg). Treatment was given orally, twice a day for 7 days in all the three groups postoperatively. Primary endpoints were comparative effectiveness in HR and blood pressure reduction following treatment. RESULTS: IST was diagnosed by an electrocardiogram (12-lead) considering morphological features of P-wave and with 32% increase from baseline HR in all the three groups. Compared to IST arrthymic rate, HR was reduced in all groups following respective treatment (P = 0.05). Reduction in HR was significant (P < 0.05) in combination group followed by ivabradine which was significantly greater than metoprolol treated group. None of the treatments clinically changed the systolic, diastolic and mean blood pressure till discharge. No surgery/treatment-related complications were observed in any groups. CONCLUSION: Ivabradine stands as a pharmacological option for controlling HR and rhythm without associated side effects in postoperative CABG patients with IST.


Subject(s)
Coronary Artery Bypass/adverse effects , Ivabradine/therapeutic use , Metoprolol/therapeutic use , Tachycardia, Sinus/drug therapy , Aged , Drug Therapy, Combination , Heart Rate/drug effects , Humans , Ivabradine/administration & dosage , Ivabradine/adverse effects , Metoprolol/administration & dosage , Metoprolol/adverse effects , Middle Aged
12.
J Card Surg ; 36(8): 2992-2995, 2021 Aug.
Article in English | MEDLINE | ID: mdl-33982302

ABSTRACT

INTRODUCTION: Primary cardiac synovial sarcoma is an exceedingly rare soft tissue malignant tumor, involving either the pericardium or chambers, with a striking male predominance, prevalently seen in the fourth decade. These tumours most commonly present as breathlessness on exertion. These patients readily exhibit gastrointestinal and systemic symptoms but sometimes the presentation can be fallacious. METHODS: A 37-year old male presented with fever, breathlessness on exertion and hematuria who was managed for dengue feverat another hospital. Patient also had features of right heart failure and congestive hepatomegaly. Patient was evaluated thoroughlyand diagnosed as right atrial tumour mass for which surgical resection was done. RESULTS: The tumour mass was diagnosed as right atrial biphasic synovial sarcoma after immunohistochemistry. Patient also had thrombocytopenia which was due to increased consumption of platelets. CONCLUSIONS: Right heart biphasic synovial sarcoma, arising from the tricuspid valve in association with thrombocytopenia and right heart failure is an extremely rare entity and that can have a deceptive presentation.


Subject(s)
Heart Neoplasms , Sarcoma, Synovial , Thrombocytopenia , Adult , Heart Atria/surgery , Heart Neoplasms/complications , Heart Neoplasms/diagnosis , Heart Neoplasms/surgery , Humans , Male , Sarcoma, Synovial/complications , Sarcoma, Synovial/diagnosis , Sarcoma, Synovial/surgery , Thrombocytopenia/etiology , Tricuspid Valve
13.
Asian Cardiovasc Thorac Ann ; 29(3): 220-222, 2021 Mar.
Article in English | MEDLINE | ID: mdl-33016077

ABSTRACT

A 67-year-old man who had undergone a percutaneous coronary intervention, presented with cardiac symptoms. He was managed for acute coronary syndrome and left ventricular dysfunction. After stabilization, he underwent coronary artery bypass grafting but developed dengue hemorrhagic fever postoperatively. He was monitored for hematocrit, platelet count, liver enzymes, and daily fluid balance. His platelet count fell below 40,000/µL, and due to the increased risk of bleeding, warfarin was discontinued and single antiplatelet therapy (aspirin) was continued. After 2 weeks, parameters had normalized. Regular monitoring of hematocrit, platelet count, liver enzymes, and fluid balance played a vital role in the patient's successful recovery.


Subject(s)
Acute Coronary Syndrome/surgery , Coronary Artery Bypass/adverse effects , Severe Dengue/virology , Ventricular Dysfunction, Left/physiopathology , Ventricular Function, Left , Acute Coronary Syndrome/diagnostic imaging , Acute Coronary Syndrome/physiopathology , Aged , Humans , Male , Severe Dengue/diagnosis , Severe Dengue/physiopathology , Severe Dengue/therapy , Treatment Outcome , Ventricular Dysfunction, Left/diagnostic imaging
14.
J Public Health (Oxf) ; 42(3): 493-503, 2020 Aug 18.
Article in English | MEDLINE | ID: mdl-32490532

ABSTRACT

BACKGROUND: The rising burden of Coronavirus disease (COVID-19) has led to the mass use of hydroxychloroquine by healthcare workers (HCWs). Adverse event profile of this drug when used as prophylaxis is not well known in the literature. METHODS: A retrospective, cross-sectional study was conducted across the country using semi-structured web-based questionnaire among COVID-19 negative and asymptomatic healthcare workers, taking hydroxychloroquine prophylaxis. Descriptive and multivariate logistic-regression models were applied for analysis. RESULTS: Of the 166 participants, at least one adverse event was experienced by 37.9% participants, gastrointestinal being the most common (30.7%). Risk was higher in participants <40 years age (odd's ratio (OR): 2.44, 95% confidence interval (CI): 1.18-5.05) and after first dose of hydroxychloroquine (51.2%, OR: 2.38, 95%CI: 1.17-4.84). Hydroxychloroquine prophylaxis was initiated without electrocardiography by 80.1% of HCWs. Only 21.6% of those with cardiovascular disease could get prior ECG. CONCLUSIONS: A higher incidence of adverse events was observed when results were compared with studies involving patients on long-term hydroxychloroquine therapy. Younger age and first dose were associated with greater incidence of adverse events though all were self-limiting. Monitoring prior and during prophylaxis was inadequate even among those with cardiovascular disease and risk-factors. However, no serious cardiovascular events were reported.


Subject(s)
Antiviral Agents/adverse effects , Antiviral Agents/therapeutic use , Coronavirus Infections/drug therapy , Health Personnel/statistics & numerical data , Hydroxychloroquine/adverse effects , Hydroxychloroquine/therapeutic use , Pneumonia, Viral/drug therapy , Public Health/statistics & numerical data , Adult , COVID-19 , Coronavirus Infections/epidemiology , Cross-Sectional Studies , Female , Humans , Incidence , India/epidemiology , Male , Middle Aged , Pandemics , Pneumonia, Viral/epidemiology , Retrospective Studies , Risk Assessment , Risk Factors
15.
Pract Radiat Oncol ; 10(3): 186-194, 2020.
Article in English | MEDLINE | ID: mdl-31978591

ABSTRACT

PURPOSE: Previously a phase III trial of a hydrogel rectal spacer during prostate radiation therapy found decreased toxicity and a clinically significant improvement in bowel quality of life (QOL) at 3 years by the Expanded Prostate Cancer Index. We performed a secondary analysis to identify men less likely to benefit. METHODS AND MATERIALS: Clinical and dosimetric data for the 222 patients enrolled on the SpaceOAR phase III trial were analyzed. The volume of rectum treated to 70 Gy (V70) and the quantitative analysis of normal tissue effects in the clinic (QUANTEC) rectal dose goals were used as surrogates for clinical benefit and plan quality. Mean bowel QOL was assessed at 15 and 36 months posttreatment and the likelihood of 1× (5 points) or 2× (10 points) minimally important difference changes were assessed. RESULTS: Rectal V70 was correlated with physician scored toxicity (P = .033) and was used as a surrogate for plan quality. There was no correlation between prostate volume and rectal V70 (r = 0.077). Rectal V70 pre- and post-hydrogel was 13% and 3% for the smallest prostates (<40 mL) and 12% and 2% for the largest (>80 mL). The relative reduction in rectal V70 of 78% did not vary by prespacer V70, but the absolute reduction was greater for a higher V70. All spacer plans met the 5 QUANTEC rectal dose constraints, although 92% of control plans met all constraints. At 3 years, those not meeting all QUANTEC goals had a 15.0-point (standard deviation 15.1) decline, control patients meeting QUANTEC goals had a 4.0-point (9.5) decline, and spacer had >0.5 (7.6; P < .01). Previous surgery was not correlated with QOL (P = .8). Across prognostic groups, including age, body mass index, previous surgery, target volume, or quality of radiation plans, there was no statistically significant heterogeneity in the relative benefit of spacer in decreasing the risk of 1× or 2× the minimally important difference declines. CONCLUSIONS: There was little heterogeneity in the likelihood of spacer reducing the risk of declines in bowel QOL across clinical and dosimetric variables. Even for the >95% of plans meeting QUANTEC rectal criteria, hydrogel spacer provided potentially meaningful benefits.


Subject(s)
Prostate/surgery , Prostatic Neoplasms/surgery , Rectum/surgery , Aged , Aged, 80 and over , Humans , Male , Middle Aged , Prostate/radiation effects , Prostatic Neoplasms/radiotherapy , Rectum/radiation effects
16.
Indian J Thorac Cardiovasc Surg ; 35(1): 74-77, 2019 Jan.
Article in English | MEDLINE | ID: mdl-33060976

ABSTRACT

Percutaneous transluminal coronary angioplasty (PTCA) with drug-eluting stent placement is a well-established treatment modality for coronary stenotic lesions. Although infection involving implanted stent is rare, it can occur at any point of time, leading to high morbidity and mortality. We describe a rare case of infected coronary stents complicated with recurrent stent thrombosis, sepsis, and myocardial abscess formation after 2 years of percutaneous cornary intervention (PCI). Using multi-modality imaging final diagnoses to evaluate the precise location, extent and morphology of myocardial abscess (MA) was done. "On pump" coronary artery bypass graft (CABG) was performed, left anterior descending (LAD) artery intramyocardially was opened up, about 7-10 ml of pus was evacuated, and two drug-eluting stents (DES) were removed. The isolated identified organism was Pseudomonas aeruginosa which had remained dormant and restricted to the stent area for almost 2 years thinning the myocardium; an unusual trait of a very virulent bacterium which otherwise spreads fast to cause septicemia. The present case exemplifies the high index of clinical sensitivity with early multi-modality diagnosis, aggressive medical therapy, multidisciplinary care, and timely surgical intervention saving the patient's life in otherwise fatal condition.

17.
J Cardiothorac Surg ; 13(1): 96, 2018 Sep 25.
Article in English | MEDLINE | ID: mdl-30253784

ABSTRACT

BACKGROUND: Indian patients undergoing surgical aortic valve replacement (SAVR) differ from western populations with respect to aortic annulus size and valve disease morphology. The purpose of this post-market, non-randomized observational study was to evaluate the early hemodynamic performance of the Trifecta™ bioprosthesis (Abbott, previously St. Jude Medical, Minneapolis, US) in an Indian patient population. METHODS: From January 2014 to September 2015, 100 patients (mean age 64.4 ± 7.1 years, 62% male) undergoing SAVR for valve disease (68% stenosis, 7% insufficiency, 25% mixed pathology) were enrolled across 10 centers in India. Patients implanted with a 19-27 mm Trifecta™ valve were eligible to participate and were prospectively followed for 12-months post-implantation. Echocardiographic hemodynamic performance was evaluated at pre-implant, pre-discharge and at 12-months by an independent core laboratory. Adverse events were adjudicated by the study sponsor. Functional status at 12-months was assessed according to NYHA classification. Continuous data was summarized using descriptive statistics (mean &standard deviation,) and categorical data was summarized using frequencies and percentages. RESULT: Ninety patients (mean age 64.5, 62.2% male) completed the 12-month follow up. Significant improvements in hemodynamic valve performance were reported in 81 patients with available echocardiographic data at 12 months. Compared to baseline at 12-month follow up visit, mean effective orifice area increased from 0.75cm2 to 1.61cm2 (p < 0.0001), mean pressure gradient reduced to 10.42 mmHg from 51.47 mmHg (p < 0.0001), cardiac output increased from 4.46 l/min to 4.85 l/min (P 0.9254). Compared to baseline, functional status improved by ≥1 NYHA class in 75% of patients at 12 months (95% Clopper-Pearson (Exact) confidence limit [64.6%, 83.6%]). No instances of early mortality (< 30 days from index procedure) or structural valve dysfunction were reported. CONCLUSION: In an Indian patient population, implantation of the Trifecta™ bioprosthesis is shown to be safe and associated with favorable early hemodynamic performance and improved functional status at 12 months. TRIAL REGISTRATION: The clinical study has been registered under Clinical Trial Registry-India ( http://www.ctri.nic.in ) and registration number is CTRI/2014/02/004434 registered on 25 February 2014 retrospectively registered.


Subject(s)
Aortic Valve/surgery , Bioprosthesis , Heart Valve Prosthesis Implantation/methods , Heart Valve Prosthesis , Aged , Aged, 80 and over , Aortic Valve/physiopathology , Aortic Valve Insufficiency/physiopathology , Aortic Valve Insufficiency/surgery , Aortic Valve Stenosis/physiopathology , Aortic Valve Stenosis/surgery , Echocardiography , Female , Follow-Up Studies , Hemodynamics/physiology , Humans , Male , Middle Aged , Retrospective Studies , Time Factors
18.
Pract Radiat Oncol ; 8(1): e7-e15, 2018.
Article in English | MEDLINE | ID: mdl-28951089

ABSTRACT

BACKGROUND: We previously reported the results of a phase 3 trial evaluating a prostate/rectal hydrogel spacer during prostate intensity modulated radiation therapy, which resulted in decreased rectal dose and toxicity and less decline in bowel quality of life (QOL). A secondary analysis was performed to correlate penile bulb dose and sexual QOL. METHODS AND MATERIALS: Sexual QOL was measured with the Expanded Prostate Cancer Index Composite (EPIC) by mean scores, the proportion of patients with a minimal clinically important difference (MID), and analyses of the different items composing the sexual domain. RESULTS: A total of 222 men enrolled with median follow-up of 37 months. Hydrogel reduced penile bulb mean dose, maximum dose, and percentage of penile bulb receiving 10 to 30 Gy (all P < .05) with mean dose indirectly correlated with erections sufficient for intercourse at 15 months (P = .03). Baseline EPIC was low (53 [standard deviation ± 24]) with no difference between arms (P > .1). A total of 41% (88/222) of men had adequate baseline sexual QOL (EPIC >60 (mean, 77 [± 8.3]). This subgroup at 3 years had better sexual function (P = .03) with a spacer with a smaller difference in sexual bother (P = .1), which resulted in a higher EPIC summary on the spacer arm (58 [±24.1] vs control 45 [± 24.4]) meeting threshold for MID without statistical significance (P = .07). There were statistically nonsignificant differences favoring spacer for the proportion of men with MID and 2× MID declines in sexual QOL with 53% vs 75% having an 11-point decline (P = .064) and 41% vs 60% with a 22-point decline (P = .11). At 3 years, more men potent at baseline and treated with spacer had "erections sufficient for intercourse" (control 37.5% vs spacer 66.7%, P = .046) as well as statistically higher scores on 7 of 13 items in the sexual domain (all P < .05). CONCLUSIONS: The use of a hydrogel spacer decreased dose to the penile bulb, which was associated with improved erectile function compared with the control group based on patient-reported sexual QOL.


Subject(s)
Prostatic Neoplasms/radiotherapy , Quality of Life/psychology , Radiotherapy, Intensity-Modulated/psychology , Sexual Behavior/psychology , Humans , Male , Radiotherapy, Intensity-Modulated/methods
19.
Int J Radiat Oncol Biol Phys ; 97(5): 976-985, 2017 04 01.
Article in English | MEDLINE | ID: mdl-28209443

ABSTRACT

PURPOSE: SpaceOAR, a Food and Drug Administration-approved hydrogel intended to create a rectal-prostate space, was evaluated in a single-blind phase III trial of image guided intensity modulated radiation therapy. A total of 222 men were randomized 2:1 to the spacer or control group and received 79.2 Gy in 1.8-Gy fractions to the prostate with or without the seminal vesicles. The present study reports the final results with a median follow-up period of 3 years. METHODS AND MATERIALS: Cumulative (Common Terminology Criteria for Adverse Events, version 4.0) toxicity was evaluated using the log-rank test. Quality of life (QOL) was examined using the Expanded Prostate Cancer Index Composite (EPIC), and the mean changes from baseline in the EPIC domains were tested using repeated measures models. The proportions of men with minimally important differences (MIDs) in each domain were tested using repeated measures logistic models with prespecified thresholds. RESULTS: The 3-year incidence of grade ≥1 (9.2% vs 2.0%; P=.028) and grade ≥2 (5.7% vs 0%; P=.012) rectal toxicity favored the spacer arm. Grade ≥1 urinary incontinence was also lower in the spacer arm (15% vs 4%; P=.046), with no difference in grade ≥2 urinary toxicity (7% vs 7%; P=0.7). From 6 months onward, bowel QOL consistently favored the spacer group (P=.002), with the difference at 3 years (5.8 points; P<.05) meeting the threshold for a MID. The control group had a 3.9-point greater decline in urinary QOL compared with the spacer group at 3 years (P<.05), but the difference did not meet the MID threshold. At 3 years, more men in the control group than in the spacer group had experienced a MID decline in bowel QOL (41% vs 14%; P=.002) and urinary QOL (30% vs 17%; P=.04). Furthermore, the control group were also more likely to have experienced large declines (twice the MID) in bowel QOL (21% vs 5%; P=.02) and urinary QOL (23% vs 8%; P=.02). CONCLUSIONS: The benefit of a hydrogel spacer in reducing the rectal dose, toxicity, and QOL declines after image guided intensity modulated radiation therapy for prostate cancer was maintained or increased with a longer follow-up period, providing stronger evidence for the benefit of hydrogel spacer use in prostate radiation therapy.


Subject(s)
Prostatic Neoplasms/epidemiology , Prostatic Neoplasms/radiotherapy , Radiation Injuries/epidemiology , Radiation Injuries/prevention & control , Radiation Protection/statistics & numerical data , Rectal Diseases/epidemiology , Rectal Diseases/prevention & control , Adult , Aged , Causality , Dose Fractionation, Radiation , Follow-Up Studies , Humans , Longitudinal Studies , Male , Middle Aged , Organs at Risk/radiation effects , Prevalence , Prostatic Neoplasms/psychology , Quality of Life/psychology , Radiation Injuries/psychology , Radiation Protection/instrumentation , Radiotherapy, Conformal/methods , Radiotherapy, Conformal/psychology , Radiotherapy, Conformal/statistics & numerical data , Radiotherapy, Image-Guided/psychology , Radiotherapy, Image-Guided/statistics & numerical data , Rectal Diseases/psychology , Risk Factors , Treatment Outcome , United States/epidemiology
20.
J Community Support Oncol ; 14(2): 72-5, 2016 Feb.
Article in English | MEDLINE | ID: mdl-26955660

ABSTRACT

Primary bladder adenocarcinoma (PBA) is an epithelial malignancy with pure glandular differentiation, without evidence of typical urothelial (transitional cell) carcinoma. PBA is rare, accounting for 0.5%-2% of all malignant bladder neoplasms, and it is seen more frequently in men than in women and is commonly diagnosed in the sixth decade of life.¹â»³ Clinical presentation includes hematuria and symptoms of bladder irritation.² PBA is common in schistosomiasis-endemic regions and among patients with congenital bladder exstrophy (ectopia vesicae); it mostly arises in the trigone and posterior bladder wall.4 In contrast, urachal adenocarcinomas arise within urachal remnants (residual tissues from the embryonic allantoic stalk connecting the umbilicus and bladder), close to the dome and anterior wall of the bladder. Morphologically, PBA is classifed into enteric and nonenteric types, which includes mucinous, signetring cell variant, clear-cell type, hepatoid, and mixed forms.² Currently, there is no standard of care in the management of PBA. We present the case of a patient with metastatic PBA with intestinal differentiation and wild-type KRAS, who was treated with colorectal cancer regimens.

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