bluuebunny/crossref_metadata_2025 huggingface dataset:
Modified technique for parastomal hernia repair in patients with intractable stoma‐care problems
Authors: Van Sprundel T. C. , Gerritsen van der Hoop A.
Published: August 2005

Objective  Although stoma relocation is generally the first choice of treatment for parastomal hernia, a repair using polypropylene prosthetic mesh is sometimes employed in cases of parastomal hernia recurrence. Use of this mesh, however, has been associated with a high risk of bowel erosion, adhesions formation, and fistulization. We therefore began to use expanded polytetrafluoroethylene (ePTFE) mesh to perform an onlay parastomal hernia repair. Our initial clinical experience with this procedure is described.

Patients and methods  Sixteen patients aged 39–70 years with intractable stoma problems underwent a modified intra‐abdominal onlay technique with implantation of a large (26 × 36 cm) sheet of ePTFE mesh.

Results  During a median follow‐up of 29 months (range, 5–52 months), no mesh‐related bowel erosion, fistulization, or adhesion formation were observed. Two patients had a recurrence of the hernia due to technical failure. Re‐operation in one of these resulted in wound dehiscence and removal of the contaminated mesh. Another patient developed intestinal obstruction postoperatively. The mesh was removed, and a gastrointestinal stromal tumour was found. Finally, a nonmesh related small bowel erosion required removal of the mesh in one patient. All other patients had full relief of symptoms.

Conclusion  The modified onlay technique using a large sheet of ePTFE prosthetic mesh is a feasible option for treatment of parastomal hernia recurrence. Possible advantages of the procedure include stoma preservation, strengthening of the abdominal wall, and a reduced risk of recurrence, contamination, fistulization, and bowel adhesions and erosion.
How has the ‘two‐week wait’ rule affected the presentation of colorectal cancer?
Authors: Chohan D. P. K. , Goodwin K. , Wilkinson S. , Miller R. , Hall N. R.
Published: August 2005

Objective  To assess the impact of the ‘two‐week wait’ rule on the presentation of colorectal cancer.

Methods  A retrospective study of all patients referred to a fast‐track clinic in a colorectal cancer centre over an 18‐month period, documenting outcome, especially colorectal cancer diagnosis. Comparison was made with patients diagnosed with colorectal cancer presenting via other routes in the same time period.

Results  Over an 18‐month period, 462 patients were seen in the fast‐track clinic and 64 (13.8%) were diagnosed with colorectal cancer. A further 131 patients with colorectal cancer presented to the department in the same time period through other means; 66 via standard out‐patient letters, 26 from other departments and 39 (20%) as emergency admissions. Median (range) time to first clinic was 12 (2–28) days for fast‐track and 24 (1–118) days for standard referrals (P < 0.0001); median time to first treatment was a further 36 (9–134) and 36.5 (1–226) days, respectively. The fast‐track cohort had more advanced staging than those referred by standard letter. There were 19 Dukes' B, 22 Dukes' C and 14 Dukes' D cancers in the fast‐track group compared with 28 Dukes' B, 25 Dukes' C and 6 Dukes' D in the standard referral group. After patient interview, only 337 (73%) of 462 fast‐track patients appeared to fulfil the referral criteria but of the 64 diagnosed with cancer, 59 (92%) satisfied the criteria. Of the 66 patients with cancer referred by standard letter, 61 (92%) fulfilled the criteria.

Conclusion  Patients referred to the fast‐track clinic were seen quicker than those referred by standard letter, but they tended to have more advanced disease. The fast‐track referral criteria were fulfilled by most patients with cancer (whether or not they were referred to the fast track clinic), confirming their validity. After detailed interview in the clinic, a quarter of fast‐track referrals were found not to satisfy referral criteria, suggesting that prioritization in primary care could be improved.
Long‐term outcome of per anum intersphincteric rectal dissection with direct coloanal anastomosis for lower rectal cancer
Authors: Yoo J.‐H. , Hasegawa H. , Ishii Y. , Nishibori H. , Watanabe M. , Kitajima M.
Published: August 2005

Objective  The authors have performed per anum intersphincteric rectal dissection. With direct coloanal anastomosis for cases of lower rectal cancer in which the distal surgical margin is difficult to secure by the double stapling technique. The aim of this study was to evaluate the long‐term outcome and to clarify the surgical indications for this operation.

Patients and methods  Between 1993 and 2002, 31 patients underwent per anum intersphincteric rectal dissection with direct coloanal anastomosis. Of these, two patients (one stage 0 and one stage IV) were excluded from the analysis of oncological outcome. The remaining 29 patients formed the basis of this study. The median follow‐up was 57 months (range 6–106 months).

Results  Local recurrence and distant metastasis developed in 9 and 3 patients, respectively. Local recurrence rate for pT1 was significantly lower than that for pT2/T3 disease. The local recurrence rate cases with tumours less than 3 cm was significantly lower than that for tumours sized 3 cm or more. The distant metastasis rate for cases with lymph node metastasis was significantly higher than that for cases without lymph node metastasis. There was an association between distant metastasis and TNM or pT stage. The overall survival rates for stage I, II and III were 85%, 80% and 89%, respectively. No significant defference was seen in total Cleveland Clinic incontinence score between per anum intersphincteric rectal dissection with direct coloanal anastomosis and the double stapling technique.

Conclusion  The surgical indications of this operation should be limited to patients with T1 rectal cancer or tumours less than 3 cm.
Double‐blind randomised trial comparing 5‐fluorouracil plus leucovorin to placebo for metastatic colorectal carcinoma
Authors: Madden M. , Goldberg P. , Geddes C. , Van Der Merwe L.
Published: August 2005

Objective  Previous randomised trials of chemotherapy for metastatic colorectal cancer have not concealed the allocation of treatment from participants. Most of these unblinded trials showed improved survival with chemotherapy. This trial used a double‐blind design to test the hypothesis that there is no difference between the effect of 5‐fluorouracil plus leucovorin and the effect of placebo on the survival of subjects with metastatic colorectal cancer.

Patients and methods  In one hospital, 147 subjects with metastatic colorectal cancer were studied from 1989 to 2001. 73 were allocated chemotherapy with 5‐fluorouracil plus leucovorin. 74 were allocated placebo. The primary end point was survival after randomization. Secondary end points were performance score, quality of life, serum level of carcinoembryonic antigen (CEA) and toxicity of treatment.

Results  One hundred and forty‐two patients were followed up until death. The median survival time in the chemotherapy group was 8.7 months (95% confidence interval (CI) 6.9–11.0 months) compared to 6.7 months in the placebo group (95% CI 5.3–7.9 months). Chemotherapy did not affect performance status but slowed the rise of CEA and caused appreciable toxicity.

Conclusions  In this double‐blind trial, chemotherapy with 5‐fluorouracil plus leucovorin did not improve survival, did not impair performance, but caused appreciable toxicity.
Feasibility and morbidity of reversal of Hartmann's
Authors: Banerjee S. , Leather A. J. M. , Rennie J. A. , Samano N. , Gonzalez J. G. , Papagrigoriadis S.
Published: August 2005

Objective  Reversal of Hartmann's is a major surgical procedure and associated with substantial morbidity and mortality.

Method  This study retrospectively analysed the data at a single centre over an eight‐year period to assess the clinical results and morbidity of reversal of Hartmann's.

Results  One hundred and ten Hartmann's procedures were performed during the period. Only 66 (61%) of patients had a reversal. Advanced age and comorbidity were the primary reasons for not reversing. Complications among the 66 patients (36 males and 30 females) who underwent reversal occurred in 26 (41%). There were no deaths. Patients who underwent reversal were ASA 2 (60%), ASA 3 (25%) and ASA 4 (4.6%). Univariate analysis demonstrated a significant association between complications following reversal and ASA grade (P =0.01), and hypertension (P = 0.03) There was no correlation between the patient variables and anastomotic leakage. Multiple logistic regression analysis showed a significant influence of hypertension, smoking and ASA grade on complications.

Conclusions  About 40% of patients who undergo Hartmann's procedure will not have a reversal. Reversal is a feasible operation for selected patients, but there is a high complication rate.
Response to neoadjuvant therapy for rectal cancer: influence on long‐term results
Authors: Biondo S. , Navarro M. , Marti‐Rague J. , Arriola E. , Pares D. , Del Rio C. , Cambray M. , Novell V.
Published: August 2005

Objective  Pre‐operative treatment with chemoradiotherapy (CRT) seems to improve local control and overall survival in patients with rectal cancer. The aims of the study were to analyse the impact on overall, disease free and cancer related survival of tumour response to pre‐operative CRT and to analyse the influence of the degree of response on long‐terms results.

Patients and methods  Patients with a locally advanced rectal cancer, treated by pre‐operative CRT were studied. A radical resection of the rectal tumour with mesorectal excision was performed within 6–8 weeks. Judged on the final TNM classification patients were considered responders when the tumour showed histologically a complete response, microscopic residual disease or a partial response. Non‐responders were those in whom the extent of disease remained stable or progressed.

Results  Radical excision was performed in 103 patients, and a palliative resection in five. Forty‐three patients underwent abdominoperineal resection and 65 anterior resection of the rectum. Seventy‐one (65.7%) patients showed a response to CRT, while 37 (34.3%) did not. The overall local and distant recurrence rates were 6.8% and 21.3%. Tumour recurrence (P < 0.008) and disease free survival (P < 0.007) were significantly different in responders and nonresponders. Of the 71 responders, 16 had a pathological complete response, 27 had persisting microscopic disease and 28 had macroscopic residual disease. No differences in cancer specific outcome were observed in these groups.

Conclusion  Pathological response to pre‐operative CRT is associated with improved tumour recurrence and disease‐free survival rates. Any response to pre‐operative CRT appears to improve outcomes as much as a complete response.
Evolution of the two‐week rule pathway – direct access colonoscopy vs outpatient appointments: one year's experience and patient satisfaction survey
Authors: Maruthachalam K. , Stoker E. , Chaudhri S. , Noblett S. , Horgan A. F.
Published: August 2005

Objectives  The aim of this study was to compare the effectiveness of Direct access colonoscopy (DAC) vs outpatient appointments for two‐week rule colorectal cancer referrals and to evaluate the satisfaction of patients referred through these routes.

Patients and methods  Data were collected prospectively from January 2003 to December 2003 on patients who were referred for DAC or outpatient appointments at the discretion of the referring General practitioner via the Lower GI two‐week rule pathway. A postal questionnaire was used to survey patient satisfaction.

Results  Six hundred and thirty‐nine patients were referred via the two‐week rule pathway; 188 patients underwent colonoscopy at their initial hospital visit and 19 (10.1%) colorectal cancers were diagnosed; 442 patients had an outpatient appointment and 32 (7.2%) colorectal cancers were identified. There were 7 (1%) inappropriate referrals and 2 patients refused investigations. All outcome parameters measured were reduced for patients referred directly for colonoscopy including time to definitive investigations (Median 9 vs 52 days P < 0.0001), time to histological diagnosis (Median 14 vs 42 days P < 0.0001) and time to treatment (Median 55 vs 75 days P < 0.0483). One hundred and seventy patients were surveyed by the postal questionnaire of whom 127 (75%) responded. Ninety‐eight percent of patients were satisfied with the service provided. Four (6.6%) of 60 patients who had undergone direct access colonoscopy expressed a desire to be seen at the outpatient department initially.

Conclusions  Direct access colonoscopy results in significantly reduced times to histological diagnosis and definitive treatment in patients with colorectal cancer. Patients can be directly admitted for investigations bypassing the outpatient clinic without affecting patient satisfaction.
A technically difficult endorectal ultrasound is more likely to be inaccurate
Authors: Zammit M. , Jenkins J. T. , Urie A. , O'Dwyer P. J. , Molloy R. G.
Published: August 2005

Objective  Endorectal ultrasound (ERUS) is well established as an accurate modality for local staging of rectal tumours. The aim of this study was to identify reasons for inaccurate staging of tumours, and to assess whether difficulties encountered during scanning are likely to influence accuracy.

Patients and methods  ERUS was performed by a single operator using a 10 MHz rigid instrument. One hundred and seventeen patients that had both ERUS and surgery are included in this study (patients that had pre‐operative radiotherapy were excluded). During ERUS, procedural conditions and limiting factors were recorded. Data was collected prospectively.

Results  In 78 (66.7%) patients no technical difficulty was encountered during ERUS. In this group accuracy was 80% for T‐stage and 77% for N‐stage. Specific reasons for inaccuracy identified in this group were: inflammatory lymph nodes (from a tumour associated abscess and a colovesical fistula) and deep biopsy causing a submucosal defect with intramural haemorrhage in benign lesions (2 cases). In the remaining 39 (33.3%), the following problems were encountered: stenotic lesions (23), patient discomfort (8), poor bowel preparation (6), and scarring from previous surgery (2). In 11 patients from this group, the scan was considered inconclusive and no stage could be determined. For the other 28, the accuracy for T‐stage was 68% and for N‐stage 67%.

Conclusion  A technically difficult ERUS is likely to give an inconclusive or inaccurate result for both T‐stage (P = 0.001) and N‐stage (P = 0.003). In this situation a repeat scan may be considered (where appropriate). Alternatively, further assessment by MRI or flexible endoscopic ultrasound may be considered.
Management of the rectal stump after emergency sub‐total colectomy: which surgical option is associated with the lowest morbidity?
Authors: Trickett J. P. , Tilney H. S. , Gudgeon A. M. , Mellor S. G. , Edwards D. P.
Published: August 2005

Objective  To identify the preferred surgical management of the rectal stump after emergency subtotal colectomy (ESC) for acute severe colitis by assessing the morbidity associated with each option.

Patients and methods  Consecutive patients undergoing ESC at a district general hospital between 1999 and 2004 were retrospectively audited for pathology, rectal stump complications and length of postoperative hospital stay (POS).

Results  Thirty‐seven ESCs were performed, 34 were undertaken for disease refractory to medical treatment, 2 for toxic mega colon and 1 for perforation. Thirty‐four cases were for ulcerative colitis, 2 Crohn's colitis and 1 infective colitis. Twenty‐seven had an intraperitoneal and 10 a subcutaneously placed closed rectal stump. The median POS for patients with a subcutaneously placed stump was shorter than for those with an intraperitoneal stump, 8 and 15 days, respectively (P = 0.04). Two patients had leakage from an intraperitoneal stump, prolonging POS (33 and 193 days). Three of the subcutaneous stumps leaked causing wound infection but not prolonging the POS (6, 7 and 16 days).

Conclusion  Avoiding a second stoma by closing the rectal stump after ESC has been confirmed as acceptable practice by studies over the last 15 years, reporting no overall increase in complications. The location of a closed rectal stump appears to influence the incidence of pelvic sepsis. The lowest pelvic sepsis rate is associated with subcutaneous placement; despite a higher wound infection rate this option appears to be associated with a lower total morbidity reflected in a shorter POS.
Use of libraries and electronic information resources by primary care staff: outcomes from a survey
Authors: Doney Liz , Barlow Helen , West Joe
Published: August 2005

Objectives:  To assess the use of existing libraries; usage of the Internet and biomedical databases; and need for training on use of the Internet and biomedical databases for primary care staff.

Methods:  A postal survey of general practitioners (GPs), practice nurses (PNs) and practice managers (PMs) in Nottingham and Rotherham, UK.

Results:  Overall, 243 questionnaires were used. The response rate in Nottingham was 24%, in Rotherham it was 34%. Reported use of libraries was low (30%), with PNs reporting significantly higher usage (65%) than others (P < 0.01). Most respondents reported using the Internet (81%), but fewer (44%) reported using databases. GPs and PNs were significantly more likely to report using databases than PMs (P < 0.01). Lack of training was the most reported barrier to using the Internet (67%) and databases (52%). Overall, 52% of respondents reported wanting Internet training, 64% wanted database training. The percentages requesting training on databases were high among GPs and PNs, but significantly lower for PMs (P = 0.02).

Conclusions:  There are differences in the usage of libraries and electronic resources among the primary care team, and in reported training needs. While the reported levels of usage of the Internet and biomedical databases are encouraging, our study identified a training need. If met, this could increase usage further.
Information‐seeking behaviour and use of the Internet by French general practitioners: a qualitative study
Authors: Boissin Florence Gonod
Published: August 2005

Background:  Numerous studies deal with the use of computers and the Internet in the health sector. Most of these studies show an increase in the use of the new technologies in searching for medical information—particularly by patients—but these uses remain very heterogeneous and depend on the studies.

Aims:  The aim of this work was to consider the use of computers by French general practitioners (GPs) and to analyse the impact that computerization could have on their information‐seeking behaviour.

Methods:  The nature of the approach used is qualitative using interviews.

Results:  Most of the GPs interviewed are equipped with a computer. The policies of the government were supposed to give financial incentives for GPs to start using computers for the management of administrative procedures, but many physicians do not know how to use the new tools properly. Their computers are, in most cases, underused for searching for medical information. Most of the time, the Internet sources are thought to be unreliable.

Conclusion:  This study sheds light on the use of computers and the preferences of GPs in searching for medical information.
Efficacy of the 5‐HT1A Agonist, Buspirone Hydrochloride, in Migraineurs With Anxiety: A Randomized, Prospective, Parallel Group, Double‐Blind, Placebo‐Controlled Study
Authors: Lee Soon‐Tae , Park Jong‐Ha , Kim Manho
Published: August 2005

Objective.—To examine the efficacy of buspirone, a 5‐HT1A agonist, for migraine combined with anxiety disorder.

Background.—Modulation of the 5‐hydroxytryptamine (5‐HT) system is used for the neuropharmacology of migraine treatment; however, the involvement of the 5‐HT1A system in migraine is not fully understood.

Methods.—Seventy‐four outpatients aged 20 to 70 years (mean, 46.4; SD, 12.8) were analyzed. All subjects were diagnosed to have migraine according to the International Headache Society criteria and anxiety disorder according to DSM‐IV. Subjects were randomly assigned to treatment with either buspirone (10 mg/day) or placebo for 6 weeks. Efficacy variables included changes in headache frequency, headache intensity, Hamilton Anxiety Rating Scale (HAM‐A), Headache Self‐Efficacy Scale (HMSE), and Headache Disability Inventory (HDI). The correlation between the headache improvement and the anxiolytic effect was analyzed.

Results.—Headache frequency showed a 43.3% reduction in the buspirone‐treated group, but by only 10.3% in the placebo group. HAM‐A and HDI were also significantly more lowered in buspirone‐treated patients than in placebo‐treated patients. However, headache intensity and HMSE score were unchanged. Correlation analysis of the relation between headache frequency reduction and HAM‐A improvement, revealed no significant association.

Conclusions.—In this study, buspirone showed a prophylactic effect in migraine with anxiety disorder, which was not secondary to its anxiolytic effect. This suggests that the agonistic action for 5‐HT1A can be directly effective in migraine prophylaxis. However, more long‐term study is warranted before concluding the efficacy.
Effect of Divalproex on Metabolic Parameters Is Dose Related in Migraine Prophylaxis
Authors: Green Mark W. , Giordano Suzanne , Jiang Ping , Jafari Mahtab , Smith Thomas B.
Published: August 2005

Objective.—To examine the metabolic effects of three divalproex dosing regimens in patients with migraine.

Background.—Epidemiological and clinical studies have demonstrated a strong association between serum lipid levels and the development of coronary artery disease. Thus, it is important to understand the impact of chronically administered medications on serum lipids. Metabolic properties of divalproex, an approved and commonly used treatment for migraine prophylaxis, have not been systematically studied in patients with migraine.

Methods.—Adult patients with migraine were randomized to receive one of three daily doses of divalproex (500 mg [n = 45], 1000 mg [n = 43], or 1500 mg [n = 44]) or placebo (n = 44) for 12 weeks. Post hoc analyses were performed to determine the effects of divalproex on total cholesterol, glucose, weight, and body mass index (BMI).

Results.—The treatment groups were similar at baseline based on demographic and clinical characteristics and the use of concomitant medications. Divalproex resulted in a dose‐related mean decrease from baseline in total cholesterol: −5.7 mg/dL or 3% reduction with 500 mg/day; −8.4 mg/dL or 4% reduction with 1000 mg/day; and −12.8 mg/dL or 7% reduction with 1500 mg/day (P < .05 for 1500 mg/day vs. placebo). There were no differences between any divalproex dose group and placebo for mean change from baseline in glucose, weight, or BMI.

Conclusions.—Divalproex results in a dose‐dependent reduction in serum cholesterol within the first 3 months of therapy, with no significant change in serum glucose or BMI.
Migraine Pain Location: A Tertiary Care Study of 1283 Migraineurs
Authors: Kelman Leslie
Published: August 2005

Objectives.—This study of headache location in migraine was performed (1) to document the location of pain in a large group of migraine patients and (2) to assess the impact of different types of migraine, gender, aura, and headache features on the location of the headache.

Background.—The literature documenting the location of the pain of acute attack of migraine is sparse.

Methods.—A total of 1283 migraine patients (ICHD, 2004, 1.1, 1.2, 1.5.1, and 1.6) were evaluated at the 1st visit. Headache location and character were graded on a scale of 0 to 3 with 0 being none and 3 the most. Triggers were graded on a frequency scale of 0 to 3; 0 = none; 1 = less than 1/3 of time; 2 = between 1/3 and 2/3 of time; 3 = greater than 2/3 of time. Other headache features and medication responsiveness, were also recorded. Patients were stratified by migraine type and headache frequency. Combined and isolated locations, and the impact of age, gender, headache frequency, migraine types, and aura were addressed. Unremitting headache was excluded.

Results.—Migraine patients reported that the highest location frequencies were in the eyes (67.1%), temporal (58.0%), and frontal (55.9%). The lowest were diffusely (17.5%) and vertex (24.1%). The intermediate were in the occipital (39.8%) and neck areas (39.7%). Other migraine types were remarkably similar. Hemicranial location was present in 66.6% of patients, 71.2% in episodic migraine and 61.4% in chronic migraine, 67.2% in females and 63.2% in males, 59.7% inmigraine without aura and 68.9% inmigraine with aura 100% of the time. Headaches were reported on the right side in 27.3%, left side 24.3%, both sides 23.7%, either side 15.0%, and in the middle of the head in 4.6% of cases. Significant differences in headache location were seen only within migraine and not other migraine types. Headache location was not correlated with lifetime duration of migraine, prodrome, response to triptan, intensity, time to peak of headache, recurrence frequency, and time to recurrence.

Conclusions.—This study provides a detailed documentation of headache location in a large cohort of patients. The commonest locations are the orbital, frontal, and temporal areas and least common sites being diffuse and the vertex. A single location is infrequent. Hemicranial location is present in two thirds of subjects and a quarter each are on the left side, right side, and both sides. The locations of the headache are very similar in different migraine types, but there are some differences. Under age 21 and older patients tended to show some differences in location and side. Location differences are seen with gender, headache frequency, and aura. Location shows many correlations with triggers and headache features.
Serotonin Transporter Gene Polymorphism and Migraine in the Korean Population
Authors: Kim Woo‐Kyung , Kim Hyun‐Sook , Kim Won‐Joo , Lee Kyung‐Yul , Park Hyojin , Kim Chan‐Hyung , Kim Se Joo , Choi Young‐Chul
Published: August 2005

Objective.—To evaluate the association between a serotonin (5‐HT) transporter gene polymorphism and migraines in Koreans.

Background.—The 5‐HT metabolism is believed to play an important part in the pathophysiology of migraines, and a polymorphism of the serotonin transporter (5‐HTT) promoter region might influence 5‐HTT expression and serotonin uptake.

Methods.—This study compared 52 patients with migraine and 170 healthy control subjects in order to determine the association between a polymorphism of the 5‐HTT gene‐linked polymorphic region (5‐HTTLPR) and migraine. Using PCR techniques, the products of the 484‐base pair (bp) fragments were denoted as being short alleles (s) and those of 528 bp as being long (l).

Results.—The genotype distribution of the healthy controls was s/s (56.5%), s/l (38.2%), and l/l (5.3%) and that of the patients with migraine was 65.4%, 30.8%, and 3.8%, respectively. No significant differences were noted in the genotype and allele frequencies of 5‐HTTLPR between the patients with migraine and the control subjects.

Conclusions.—A 5‐HTTLPR polymorphism does not appear to be involved in the genetic predisposition to migraines.
Hemicrania Continua Responsive to Verapamil
Authors: Rajabally Yusuf A. , Jacob Saiju
Published: August 2005

Hemicrania continua (HC) is a rare headache syndrome, typically responsive to indomethacin, although patients resistant to this drug have been described. Few treatment alternatives have been proposed in the literature. We here report a patient with HC whose initial excellent response to indomethacin faded but then responded remarkably to verapamil.
A Randomized, Controlled Trial of Saphenous Vein Graft Intervention with a Filter‐Based Distal Embolic Protection Device: TRAP Trial
Authors: DIXON SIMON R. , MANN J. TIFT , LAUER MICHAEL A. , CASALE PAUL N. , DIPPEL ERIC J. , STRUMPF ROBERT K. , FELDMAN ROBERT L. , SHEAR WENDY , RESAR JON R. , ZIMMER STEVAN D. , O'NEILL WILLIAM W. ,   the TRAP Investigators
Published: August 2005

The purpose of this prospective, multicenter trial was to evaluate the safety and effectiveness of the TRAP Vascular Filtration System (VFS) to reduce embolic complications during stenting of diseased saphenous vein grafts (SVGs). Patients with SVG lesions were randomly assigned to undergo stenting with or without the TRAP device. The trial was designed to enroll 752 randomized patients. However, the sponsor terminated the study after a total of 467 patients (358 randomized) were enrolled because of poor recruitment once another distal protection device was approved for clinical use. The primary study endpoint, major adverse cardiac events at 30 days, occurred in 17.3% of control patients and 12.7% of patients treated with the TRAP device (P = 0.24). There was a trend toward a lower incidence of myocardial infarction in the TRAP group compared with the control group (16.2% vs 10.5%, P = 0.12). This difference was predominantly due to a lower incidence of moderate‐large infarction (CKMB >5×) in the TRAP group. Use of the TRAP VFS during SVG intervention was safe and was associated with a trend toward a lower incidence of adverse events, however, due to low enrollment the study lacked sufficient power to detect a significant benefit with the device.
Eligibility for Use of Proximal or Distal Embolic Protection Devices During Percutaneous Intervention for Acute Myocardial Infarction
Authors: MATTICHAK STEPHEN J. , DIXON SIMON R. , SAFIAN ROBERT D. , HANZEL GEORGE S. , BOURA JUDITH A. , O'NEILL WILLIAM W.
Published: August 2005

Although there has been enthusiasm for using embolic protection devices in acute myocardial infarction, it is unclear how often these devices can be used in nonselected patients. The aim of this study was to evaluate potential eligibility for use of either proximal or distal embolic protection during primary or rescue percutaneous coronary intervention in a consecutive, nonselected population. We analyzed the angiograms of 259 consecutive patients with ST‐segment elevation myocardial infarction to determine eligibility for use of either type of protection device. Overall, 202 (78%) patients had anatomy suitable for embolic protection, including 154 (59%) who were eligible for proximal protection, 128 (49%) who were eligible for distal protection, and 80 (31%) who were eligible for both devices. Patients eligible for proximal protection were more likely to have a right coronary culprit, whereas patients eligible for distal protection were more likely to have a lesion in the left anterior descending coronary artery.
Impact of Reversibility of No Reflow Phenomenon on 30‐Day Mortality Following Percutaneous Revascularization for Acute Myocardial Infarction—Insights from a 1,328 Patient Registry
Authors: LEE CHI HANG , WONG HWEE BEE , TAN HUAY CHEEM , ZHANG JUN JIE , TEO SWEE GUAN , ONG HEAN YEE , LOW ADRIAN , SUTANDAR ANTONO , LIM YEAN TENG
Published: August 2005

Background: Occurrence of no reflow phenomenon during percutaneous coronary intervention (PCI) is associated with increased mortality. Although intracoronary medications can improve coronary flow, the effect on mortality is not known.

Methods: Patients who had PCI for myocardial infarction (MI) at the Singapore National University Hospital from January 2000 to March 2004 were studied. Our analysis stratified patients into three groups according to the occurrence and persistence of no reflow during PCI. (1) Adequate reflow: without no reflow occurrence; (2) Reversible no reflow: no reflow occurred, but final thrombolysis in myocardial infarction (TIMI) 3 flow restored after intracoronary medications; and (3) Refractory no reflow: no reflow occurred and persisted, final TIMI flow < 3 despite medications. Thirty‐day mortality was determined for each group.

Results: A total of 1,328 patients (82% male), 703 (53%) underwent primary PCI and 625 (47%) rescue PCI were analyzed. Among the study patients, no reflow (including reversible and refractory) occurred in 135 patients (10.2%). Intracoronary verapamil, adenosine, nitroprusside, or a combination of drugs were used to treat the no reflow in 70.0%, 17.7%, 3.5%, and 8.8% of cases, respectively. Intracoronary medications successfully restored final TIMI 3 in 108 patients (80%, reversible no reflow). The remaining 27 patients (20%) have final TIMI < 3 (refractory no reflow). In comparison with the adequate reflow and reversible no reflow groups, those with refractory no reflow had an increased 30‐day mortality (3.7% vs 2.8% vs 32.0%, P < 0.001). Logistic regression analyses showed that patients with refractory no reflow had a significantly higher 30‐day mortality compared to patients with adequate reflow (P < 0.001) and reversible no reflow (P = 0.001), but no significant differences in the 30‐day mortality between patients with adequate reflow and reversible no reflow (P = 0.157) were detected after adjusting for relevant covariates.

Conclusion: Among patients undergoing PCI for MI, reversible no reflow was associated with a significantly lower 30‐day mortality compared with the refractory counterpart.
Transcatheter Device Closure of Interatrial Septal Defects in Patients with Hypoxia
Authors: ILKHANOFF LEONARD , NAIDU SRIHARI S. , ROHATGI SAMEER , ROSS MITCHELL J. , SILVESTRY FRANK E. , HERRMANN HOWARD C.
Published: August 2005

Background: There has been growing interest in transcatheter closure of interatrial septal defects (IASDs) for a variety of indications, but reports are limited in patients with hypoxia from right‐to‐left shunting.

Methods: Between August 2000 and October 2004, 181 patients were referred to our institution for elective closure of a patent foramen ovale (PFO) or atrial septal defect (ASD). Among these patients, 10 (5.5%) underwent closure for hypoxia due to persistent or intermittent right‐to‐left shunting. Clinical evaluation, including echocardiography with color Doppler and agitated saline, was performed in all patients to determine the degree of right‐to‐left shunting. Defects were closed with Amplatzer (n = 4) or Cardioseal (n = 6) devices, under transesophageal (TEE) or intracardiac echocardiography (ICE) guidance.

Results: Mean age was 62.7 years (range: 31–88 years) with 70% female. Characteristics for closure included four patients with persistent hypoxia and six with intermittent hypoxia, including two with platypnea‐orthodeoxia syndrome. All patients had echocardiography showing moderate (n = 6) or severe (n = 4) shunting. Patients had significant comorbidities, including chronic lung disease requiring supplemental oxygen (n = 5) and congestive heart failure (n = 2). TEE guidance was used in three patients, and ICE was performed in the remainder. Mean closure device diameter was 27 mm. Mean preprocedural arterial oxygen saturation of 86.7% improved to 95.9% immediately after closure, with color Doppler and agitated saline revealing the absence of (n = 5) or mild (n = 5) shunting. In‐hospital major complications were limited to one patient with a transient ischemic attack after an initially unsuccessful closure attempt.

Conclusions: Percutaneous closure of IASDs in a heterogeneous group of patients with hypoxia can be safely and effectively performed. The procedure results in immediate arterial saturation improvement and reduced right‐to‐left shunting.
Comparison of the X‐SIZER Thrombectomy Device with Adjunct Abciximab During Primary Angioplasty and Stenting for ST‐Segment Elevation Myocardial Infarction
Authors: LOW ADRIAN F. , LIM YEAN‐TENG , TEO SWEE‐GUAN , BUDIONO BAMBANG , SUTANDAR ANTONO , TAN HUAY‐CHEEM
Published: August 2005

Objective: To evaluate the safety and efficacy of the X‐SIZER thrombectomy device versus the use of abciximab during primary angioplasty for acute ST‐elevation myocardial infarction (STEMI).

Design: Retrospective analysis of patients undergoing primary angioplasty for STEMI from October 2000 to December 2002 using the X‐SIZER thrombectomy device versus abciximab.

Setting: National University Hospital, Singapore.

Patients: Out of 79 patients, 44 underwent X‐SIZER use, while 35 received adjunct abciximab. Both groups were similarly represented with regards to age, gender, risk factors, target vessel site/diameter, cardiogenic shock, and onset of chest pain to procedure time. The infarct‐related artery was occluded in 88.6% in both groups.

Interventions: A 2‐mm X‐SIZER was used in 34/44 (77.3%), while a 1.5‐mm device was used in the remainder. Final TIMI 3 flow was obtained in 38/44 (86.4%) in the X‐SIZER group compared to 26/35 (74.3%) in the abciximab group (P = 0.175).

Main Outcome Measures: Coronary TIMI flow rate, electrocardiogram (ECG) resolution, slow flow/no reflow phenomenon, and patient outcome (death, cardiac failure, or repeat revascularization) at 1 month.

Results: ECG resolution and slow flow/no reflow were better in the X‐SIZER group (77.3% vs 54.3%, P = 0.031; 9.1% vs 25.7%, P = 0.047, respectively). Patient outcome at 1 month was, however, not significantly different (18.2% vs 17.1%, P = 0.904, respectively, for X‐SIZER and abciximab).

Conclusion: X‐SIZER thrombectomy during primary percutaneous coronary intervention for thrombus‐laden STEMI is a safe and effective strategy. When compared to patients receiving abciximab, it was associated with improved ECG resolution, less slow flow/no reflow and a trend to better TIMI 3 flow.
The Impact of Age in the Immediate and Long‐Term Outcomes of Percutaneous Mitral Balloon Valvuloplasty
Authors: SANCHEZ PEDRO L. , RODRIGUEZ‐ALEMPARTE MAXIMO , INGLESSIS IGNACIO , PALACIOS IGOR F.
Published: August 2005

Background: Differences in age, clinical characteristics, and valve morphology may account for controversial results of percutaneous mitral balloon valvuloplasty (PMV).

Methods: We have previously reported the immediate and long‐term clinical follow‐up (50 ± 45 months) of 879 patients who underwent PMV at the Massachusetts General Hospital. In the present study, we used this database to determine the impact of age in the immediate and long‐term outcome of PMV. For purpose of analysis, these patients were divided into four age groups: group 1 (≤35 years), group 2 (36–55 years), group 3 (56–75 years), and group 4 (>75 years).

Results: The incidence of atrial fibrillation, calcified valves under fluoroscopy, higher echocardiographic score, New York Heart Association (NYHA) class IV and pre‐PMV mitral regurgitation (MR) increased with patient's age. As patients became older, a lower post‐PMV mitral valve area (2.1 ± 0.7, 2.0 ± 0.6, 1.8 ± 0.6, and 1.6 ± 0.6; P < 0.0001) and progressive decrease in procedural success (81.4%, 80.5%, 65.3%, and 53%; P < 0.0001) were observed. Younger age was identified as an independent predictor of PMV success by multiple stepwise logistic regression (odds ratio [OR]: 3.33; confidence interval [CI]: 1.41–7.69, P = 0.006). Furthermore, age was identified as an independent predictor of long‐term events by Cox regression analysis (risk ratio [RR]: 1.02; CI: 1.01–1.03, P < 0.00001). However, the effect of age seemed to be blunted by the morphology of the valve at follow‐up, as patients with echocardiogram score >8 in groups 2, 3, and 4 presented similar combined event‐free survival (death, mitral valve replacement, or redo PMV).

Conclusion: Age is an important predictor of immediate and long‐term outcomes after PMV, particularly in patients with optimal mitral valve morphology.
Left Ventricular Remodeling and Systolic Deterioration in Acute Myocardial Infarction: Findings from the Stent‐PAMI Study
Authors: MATTICHAK STEPHEN J. , HARJAI KISHORE J. , DUTCHER JACOB R. , BOURA JUDITH A. , STONE GREGG , COX DAVID , BRODIE BRUCE R. , O'NEILL WILLIAM W. , GRINES CINDY L.
Published: August 2005

Background: Left ventricular systolic deterioration (LVSD) develops in some patients despite successful percutaneous intervention and medical therapy for myocardial infarction (MI). We sought to determine predictors of LVSD by comparing demographic, procedural, angiographic variables, and 6‐month major adverse cardiac events (MACE) in patients with and without LVSD after MI.

Methods: We performed a posthoc analysis of patients prospectively enrolled in the Stent‐PAMI trial if they had successful percutaneous intervention for MI (<50% residual stenosis and TIMI‐3 grade flow), normal left ventricular systolic function on index ventriculogram, and protocol driven coronary angiography with ventriculography at 6 months. We defined LVSD as an absolute decrease in ejection fraction ≥15% compared to baseline value.

Results: Of the 900 patients enrolled in Stent‐PAMI, 187 patients met the inclusion criteria. LVSD developed in 30 patients (16%) and occurred independent of demographic, procedural, angiographic variables, and 6‐month MACE. Multivariate predictors of LVSD were higher baseline ejection fraction (P = 0.0065, OR 1.09; 95% CI = 1.02–1.16) and peak creatine phosphokinase (CPK) level (P = 0.0022, OR 1.04; 95% CI = 1.02–1.07).

Conclusions: LVSD occurs in a minority of patients despite successful mechanical reperfusion and occurred independent of procedural, angiographic variables, target vessel revascularization, reinfarction, and combined MACE. Infarct size (determined by peak CPK) and high baseline ejection fraction predicted development of LVSD at 6 months. LVSD in this population likely occurred by negative left ventricular remodeling.
Basic Research and Implications for Practice in Family Science: A Content Analysis and Status Report for U.S. Ethnic Groups*
Authors: Bean Roy A. , Crane D. Russell , Lewis Traci L.
Published: August 2005

Articles published in prominent family science journals over a 14‐year period were analyzed for their attention to U.S. ethnic groups. Articles were analyzed in terms of their ethnic population of interest, topic of study, type of implication for applied professionals, funding source, and sample characteristics. A number of findings indicate an increasing sensitivity and dedication to research focusing on these groups; however, fewer than 16% of the articles were found to focus on U.S. ethnic populations, and only one fourth of these offered specific recommendations to practicing family science professionals. This analysis of the family science literature provides a baseline against which future efforts in basic and applied research can be measured.
The Association of Patients' Psychosocial Well‐Being with Self and Spouse Ratings of Patient Health
Authors: Franks Melissa M. , Hong Tantina B. , Pierce Linda S. , Ketterer Mark W.
Published: August 2005

Adjustment to illness is influenced both by individual resources and the support available from a marital partner. In this study of 61 male heart patients and their wives, patients' self‐rated health and the agreement between patient and spouse ratings of the patients' health were investigated as contributing to patients' psychosocial well‐being. Patients' positive self‐rating of health and also spouses' rating that concurred with their own self‐rating were related to greater well‐being among patients. The advantage to patient well‐being of shared spouse appraisals beyond patients' own health appraisal extends the growing literature indicating the predictive utility of individual subjective health appraisals by demonstrating the added value of the perceptions of spouses who share the illness context.
Work–Family Spillover and Daily Reports of Work and Family Stress in the Adult Labor Force*
Authors: Grzywacz Joseph G. , Almeida David M. , McDonald Daniel A.
Published: August 2005

Work–family research employing nationally representative samples and multiple methods of data collection is uncommon. We used data from two affiliated national surveys to examine the distribution of work–family spillover among working adults. The National Study of Daily Experiences (n= 741), an 8‐day daily diary study using a subsample of the National Survey of Midlife Development in the United States (MIDUS; N= 2,130), allowed work–family spillover to be conceptualized and operationalized in different ways. Analyses testing family life course hypotheses indicated that self‐reported negative and positive spillover between work and family were not randomly distributed within the labor force. Age was found to have a persistent curvilinear effect on negative spillover between work and family. The prevalence of co‐occurring work and family stress reported over 8 days was comparable across nearly all the sociodemographic characteristics.
Shared Experiences, Unique Realities: Formerly Married Mothers' and Fathers' Perceptions of Parenting and Custody After Divorce*
Authors: Madden‐Derdich Debra A. , Leonard Stacie A.
Published: August 2005

Many former spouses have different and often conflicting perceptions of their postdivorce circumstances, particularly as they relate to parenting and custody. Using a symbolic interactionism framework, our study examined the relationship between these perceptual differences and coparental conflict (N= 112; representing 56 previously married couples). For both mothers and fathers, perceptual divergence regarding fathers' child‐rearing skills and perceptual divergence regarding mothers' willingness to be accommodating emerged as predictors of conflict. An overestimation of custody satisfaction by the former spouse also was associated positively with conflict.
Intergenerational Differences and Similarities in Life‐Sustaining Treatment Attitudes and Decision Factors
Authors: Mills Terry L. , Wilmoth Janet M.
Published: August 2005

A cross‐sectional sample of members of 3‐generation families was used to evaluate life‐sustaining medical treatment attitudes and decision factors for oneself and for parents. Results show that the older generation (G1) perceived mental capacity, family burden, and pain as the most important considerations. Among the middle generation (G2), family burden was not an important factor, but the type of life‐sustaining treatment was important. The youngest generation (G3) was similar to the other two generations in that mental capacity and pain were important, but a smaller percentage of the G3s considered this important.
Preserving Personhood: (Re)Membering the Spouse with Dementia*
Authors: Perry JoAnn , O'Connor Deborah
Published: August 2005

Preserving the personhood of one's partner emerged as a guiding directive for spouses caring for a partner with dementia. On the basis of data from open‐ended interviews with 38 husband and wife caregivers, four strategies that facilitate this directive were identified: maintaining continuity, sustaining existing competencies, protecting the partner from incompetence, and strategizing public encounters. From a social constructionist perspective, the focus on preserving the personhood of the partner with dementia promotes more holistic, person‐centered care. However, when examined independently, each of the strategies used to achieve this goal can present both challenges and opportunities for the spouse caregiver.
Relationship Personality, Conflict Resolution, and Marital Satisfaction in the First 5 Years of Marriage*
Authors: Schneewind Klaus A. , Gerhard Anna‐Katharina
Published: August 2005

We explore the relationship between couples' stable personality variables associated with interpersonal competencies (referred to here as relationship personality variables) and marital satisfaction with conflict resolution style as the mediating factor. Eighty‐three newlywed couples participated in the study at 6 points over 5 years at 1‐year intervals. The results indicate strong mediational effects across time. In particular, conflict resolution styles appear to form during the 1st year of marriage and are habituated thereafter to a large extent. The relationship personality variables correspond closely with conflict resolution styles, which in turn influence marital satisfaction. The implications for intervention, especially for preventive intervention in early marriage, are presented.