Development of a core information set for colorectal cancer surgery: a consensus study.

OBJECTIVE: 'Core information sets' (CISs) represent baseline information, agreed by patients and professionals, to stimulate individualised patient-centred discussions. This study developed a CIS for use before colorectal cancer (CRC) surgery. DESIGN: Three phase consensus study: (1) Systematic literature reviews and patient interviews to identify potential information of importance to patients, (2) UK national Delphi survey of patients and professionals to rate the importance of the information, (3) international consensus meeting to agree on the final CIS. SETTING: UK CRC centres. PARTICIPANTS: Purposive sampling was conducted to ensure CRC centre representation based upon geographical region and caseload volume. Responses were received from 63/81 (78%) centres (90 professionals). Adult patients who had undergone CRC surgery were eligible, and purposive sampling was conducted to ensure representation based on age, sex and cancer location (rectum, left and right colon). Responses were received from 97/267 (35%) patients with a wide age range (29-87), equal sex ratio and cancer location. Attendees of the international Tripartite Colorectal Conference were eligible for the consensus meeting. OUTCOMES: Phase 1: Information of potential importance to patients was extracted verbatim and operationalised into a Delphi questionnaire. Phase 2: Patients and professionals rated the importance information on a 9-point Likert scale, and resurveyed following group feedback. Information rated of low importance were discarded using predefined criteria. Phase 3: A modified nominal group technique was used to gain final consensus in separate consensus meetings with patients and professionals. RESULTS: Data sources identified 1216 pieces of information that informed a 98-item questionnaire. Analysis led to 50 and 23 information domains being retained after the first and second surveys, respectively. The final CIS included 11 concepts including specific surgical complications, short and long-term survival, disease recurrence, stoma and quality of life issues. CONCLUSIONS: This study has established a CIS for professionals to discuss with patients before CRC surgery.

Core Outcomes for Colorectal Cancer Surgery: A Consensus Study.

BACKGROUND: Colorectal cancer (CRC) is a major cause of worldwide morbidity and mortality. Surgical treatment is common, and there is a great need to improve the delivery of such care. The gold standard for evaluating surgery is within well-designed randomized controlled trials (RCTs); however, the impact of RCTs is diminished by a lack of coordinated outcome measurement and reporting. A solution to these issues is to develop an agreed standard "core" set of outcomes to be measured in all trials to facilitate cross-study comparisons, meta-analysis, and minimize outcome reporting bias. This study defines a core outcome set for CRC surgery. METHODS AND FINDINGS: The scope of this COS includes clinical effectiveness trials of surgical interventions for colorectal cancer. Excluded were nonsurgical oncological interventions. Potential outcomes of importance to patients and professionals were identified through systematic literature reviews and patient interviews. All outcomes were transcribed verbatim and categorized into domains by two independent researchers. This informed a questionnaire survey that asked stakeholders (patients and professionals) from United Kingdom CRC centers to rate the importance of each domain. Respondents were resurveyed following group feedback (Delphi methods). Outcomes rated as less important were discarded after each survey round according to predefined criteria, and remaining outcomes were considered at three consensus meetings; two involving international professionals and a separate one with patients. A modified nominal group technique was used to gain the final consensus. Data sources identified 1,216 outcomes of CRC surgery that informed a 91 domain questionnaire. First round questionnaires were returned from 63 out of 81 (78%) centers, including 90 professionals, and 97 out of 267 (35%) patients. Second round response rates were high for all stakeholders (>80%). Analysis of responses lead to 45 and 23 outcome domains being retained after the first and second surveys, respectively. Consensus meetings generated agreement on a 12 domain COS. This constituted five perioperative outcome domains (including anastomotic leak), four quality of life outcome domains (including fecal urgency and incontinence), and three oncological outcome domains (including long-term survival). CONCLUSION: This study used robust consensus methodology to develop a core outcome set for use in colorectal cancer surgical trials. It is now necessary to validate the use of this set in research practice.

Trial outcomes and information for clinical decision-making: a comparative study of opinions of health professionals.

BACKGROUND: Trials are robust sources of data for clinical practice; however, trial outcomes may not reflect what is important to communicate for decision-making. The study compared clinicians' views of outcomes to include in a core outcome set for colorectal cancer (CRC) surgery, with what clinicians considered important information for clinical practice (core information). METHODS: Potential outcome/information domains were identified through systematic literature reviews, reviews of hospital information leaflets and interviews with patients. These were organized into six categories and used to design a questionnaire survey that asked surgeons and nurses from a sample of CRC centers to rate the importance of each domain as an outcome or as information on a nine-point Likert scale. Respondents were re-surveyed (round 2) following group feedback (Delphi methods). Comparisons were made by calculating the difference in mean scores between the outcomes and information domains, and paired t tests were used to explore the difference between mean scores of the six outcome/information categories. RESULTS: Data sources identified 1216 outcome/information items for CRC surgery that informed a 94-item questionnaire. First-round questionnaires were returned from 63/81 (78 %) of centers. Clinicians rated 76/94 (84 %) domains of higher importance to measure in trials than information to communicate to patients in round 1. This was reduced to 24/47 (51 %) in round 2. The greatest difference was evident in domains regarding survival, which was rated much more highly as a trial outcome than an important piece of information for decision-making (difference in mean 2.3, 95 % CI 1.9 to 2.8, p <0.0001). Specific complications and quality-of-life domains were rated similarly (difference in mean 0.18, 95 % CI -0.1 to 0.4, p = 0.2 and difference in mean 0.2, 95 % CI -0.1 to 0.5, p = 0.2, respectively). CONCLUSIONS: Whilst clinicians want to measure key outcomes in trials, they rate these as less important to communicate in decision-making with patients. This discrepancy needs to be explored and addressed to maximize the impact of trials on clinical practice.

What are important outcomes of bariatric surgery? An in-depth analysis to inform the development of a core outcome set and a comparison between the views of surgeons and other health professionals (the BARIACT study).

BACKGROUND: Outcome reporting in bariatric surgery needs uniformity. A core outcome set is an agreed minimum set of outcomes reported in all studies of a particular condition, but members of the bariatric multidisciplinary team might value outcomes differently. The aim of this study was to summarise existing outcome reporting in bariatric surgery, to inform the development of a core outcome set, and to compare outcomes selected as important by type of health professional. METHODS: Outcomes reported in randomised controlled trials (RCTs) and large non-randomised studies, identified by a systematic review, were listed verbatim. Frequency of outcome reporting and uniformity of definition were assessed. A questionnaire to rate the importance of each outcome was completed by members of the bariatric multidisciplinary team. Responses to each item were scored as 1 (not essential) to 9 (absolutely essential). We ranked outcomes according to percentage deemed important (7-9) and according to respondents by type of health professional. FINDINGS: We identified 1088 individual outcomes from 90 studies (39 RCTs), grouped them into health domains, and presented them as a questionnaire with 131 items to 489 multidisciplinary team members. Most outcomes (n=920, 85%) were reported only once. The largest outcome domain was surgical complications, and 432 outcomes (42%) corresponded to an adverse event. Only a quarter of outcomes (n=461) were defined, and were often contradictory. For questionnaire responders (n=164, response rate 33·5%), most were surgeons (n=80, 48·8%), followed by dietitians (n=31, 18·9%), nurses (n=24, 14·6%), physicians (n=12, 7·3%), and others (n=16, 9·9%). Improvement in diabetes was the top outcome for all health professionals. Seven of the surgeon's top ten outcomes were adverse events, compared with three for other health professionals. Groups valued a measure of weight differently (third vs 15th for other health professionals and surgeons, respectively). INTERPRETATION: This study shows that the assessment of bariatric surgery focuses largely on adverse events and resolution of comorbidity, but that reporting is inconsistent and ill-defined. Substantial variation between the views of surgeons and those of other health professionals was evident. The next step is to provide feedback to participants and to survey their views again before a final consensus meeting to produce a core outcome set for the Benefits and Adverse events in BARIAtric surgery Clinical Trials (BARIACT) as a solution to this problem. FUNDING: National Institute for Health Research (NIHR), and the NIHR Health Technology Assessment programme. This work was also undertaken with the support of the MRC ConDuCT-II Hub (Collaboration and innovation for Difficult and Complex randomised controlled Trials In Invasive procedures, MR/K025643/1).

Long-term outcomes of concomitant aortic and mitral valve repair.

OBJECTIVE: To evaluate the short- and long-term outcomes of concomitant aortic (AVr) and mitral (MVr) valve repair. METHODS: This retrospective analysis of prospectively collected data identified patients who had undergone AVr and MVr surgery from March 1996 to October 2009. Patients were included if they had undergone combined repair on the aortic and mitral valves. Excluded were those <18 years in whom valve replacement was performed. Data were collected on the short-term morbidity and mortality (<30 postoperative days), long-term survival, and freedom from valve-related events and echocardiographic outcomes. RESULTS: A total of 65 patients underwent AVr and MVr (mean age, 56.4 ± 15.8 years, 46 men). Preoperatively, 30 patients (46.1%) had aortic insufficiency (AI) >2+, 20 patients had AI ≥2+ with aortic dilatation (30.7%), and 4 patients (6.1%) had aortic dilatation only. Of the 65 patients, 57 had tricuspid (87.6%) and 8 had bicuspid aortic valves (12.3%). All patients had mitral insufficiency preoperatively. One in-hospital death occurred (1.5%). At discharge, no patient had AI >2+ versus 30 patients preoperatively (P < .001), and 7 patients had AI >1+ versus 61 patients preoperatively (P < .001). At discharge, the mean left ventricular end-diastolic diameter was 48 ± 7 mm versus 59 ± 9 mm preoperatively (P < .007), and the mean left ventricular end-systolic diameter was 33 ± 5 mm versus 38 ± 14 mm preoperatively (P = .36). The mean clinical follow-up duration was 62 ± 45 months (median, 50; range, 1-177). At the latest follow-up visit, 17 patients were New York Heart Association class ≥2 versus 52 patents preoperatively (P < .001). Four cardiac deaths occurred, and at 1, 5, and 10 years, the freedom from cardiac death was 100%, 93.4% ± 3.7%, and 88.5% ± 5.9%, respectively. Eight valve reinterventions were required, and the freedom from valve reintervention at 1, 5, and 10 years was 95.3% ± 2.6%, 91.6% ± 3.6%, and 78.4% ± 8.0%, respectively. At 1, 5, and 10 years, the freedom from AI 2+ was 98.2% ± 1.7%, 93.4% ± 3.7%, and 88.3% ± 5.8% and the freedom from mitral insufficiency 2+ was 96.4% ± 2.4%, 93.3% ± 3.8%, and 93.3% ± 3.8%, respectively. CONCLUSIONS: Concomitant AVr/MVr is associated with acceptable survival and freedom from valve reintervention.

Early and mid-term outcomes of trans-sternal and video-assisted thoracoscopic surgery for thymoma.

OBJECTIVES: Video-assisted thoracoscopic surgery (VATS) for thymoma has uncertain safety and effectiveness in comparison with trans-sternal resection. This feasibility study compared short- and mid-term outcomes for patients undergoing these two procedures, highlights weaknesses in current research and makes recommendations for long-term technological evaluations in this field. METHODS: Consecutive thymoma cases between 2004 and 2010 were identified. Patients were divided into two groups according to surgical approach (Group I trans-sternal; Group II VATS) and comparisons were made between groups. The primary outcome was overall survival. Secondary outcomes included operative morbidity and mortality, hospital stay, recurrence rate and disease-free survival. RESULTS: Thirty-nine patients were included (Group I: n = 22 vs Group II: n = 17). There were no differences between groups at baseline for all measured covariates. No deaths occurred within 30 days of surgery. More patients in Group I developed complications (Group I: n = 10 vs Group II: n = 3; P = 0.093), while hospital stay was shorter in Group II (Group I: 6.4 ± 4.6 days vs Group II: 4.4 ± 1.8 days; P = 0.030). Five-year overall survival (Group I: 93.8 ± 6.1% vs Group II: 83.3 ± 11.2%; P = 0.425), 5-year disease-free survival (Group I: 71.0 ± 15.3% vs Group II: 83.3 ± 11.2%; P = 0.827) and recurrence rates at final follow-up (Group I: n = 2 vs Group II: n = 1; P = 0.363) were similar between the groups. CONCLUSION: VATS thymectomy for thymoma is feasible, safe and has comparable mid-term oncological outcomes to trans-sternal thymectomy. Future research is required to evaluate long-term oncological outcomes of VATS thymectomy for thymoma in national registries and randomized, controlled trials.

Developing core outcomes sets: methods for identifying and including patient-reported outcomes (PROs).

BACKGROUND: Synthesis of patient-reported outcome (PRO) data is hindered by the range of available PRO measures (PROMs) composed of multiple scales and single items with differing terminology and content. The use of core outcome sets, an agreed minimum set of outcomes to be measured and reported in all trials of a specific condition, may improve this issue but methods to select core PRO domains from the many available PROMs are lacking. This study examines existing PROMs and describes methods to identify health domains to inform the development of a core outcome set, illustrated with an example. METHODS: Systematic literature searches identified validated PROMs from studies evaluating radical treatment for oesophageal cancer. PROM scale/single item names were recorded verbatim and the frequency of similar names/scales documented. PROM contents (scale components/single items) were examined for conceptual meaning by an expert clinician and methodologist and categorised into health domains. A patient advocate independently checked this categorisation. RESULTS: Searches identified 21 generic and disease-specific PROMs containing 116 scales and 32 single items with 94 different verbatim names. Identical names for scales were repeatedly used (for example, 'physical function' in six different measures) and others were similar (overlapping face validity) although component items were not always comparable. Based on methodological, clinical and patient expertise, 606 individual items were categorised into 32 health domains. CONCLUSION: This study outlines a methodology for identifying candidate PRO domains from existing PROMs to inform a core outcome set to use in clinical trials.

Systematic review and meta-analysis of audio-visual information aids for informed consent for invasive healthcare procedures in clinical practice.

OBJECTIVE: To systematically review audio-visual (AV) interventions for promoting informed consent (IC) in clinical practice and to consider the impact of reading age adjustment. METHODS: Systematic review of randomized controlled trials (RCTs) comparing AV interventions to standard IC in clinical practice. Outcomes included recall (immediate <1 day; intermediate 1-14 days; late >14 days), satisfaction and anxiety. Data were synthesized using random effects meta-analyses. Comparisons were made between studies that did and did not adjust for participant reading age. RESULTS: Of 11,813 abstracts screened, 29 RCTs were eligible (30 intervention arms). Interventions included videos (n=17), computer programs (n=5), electronic presentations (n=3), compact discs (n=3) and websites (n=2). Meta-analysis showed AV interventions improved immediate recall (standardized mean difference [SMD] 0.64, 95% confidence interval [CI] 0.45-0.85). Results for intermediate and late recall were too heterogeneous to synthesize. AV interventions did not consistently affect either satisfaction or anxiety. Adjusting the reading age of interventions improved immediate recall (reading age interventions: adjusted SMD 1.21, 95%CI 0.81-1.61; non-reading age adjusted SMD 0.51, 95%CI 0.36-0.66). CONCLUSION: AV interventions, especially those adjusted for participant reading age, improve immediate information recall for IC. Practice implications Wider use of AV aids is justified when obtaining IC in clinical practice.

Effect of preoperative symptoms on outcomes after valve repair for degenerative aortic insufficiency.

OBJECTIVES: This study evaluated the effect of preoperative symptoms on long-term survival and valve reintervention in patients undergoing aortic valve repair (AVr) for severe degenerative aortic insufficiency (AI). METHODS: Between March 1996 and June 2010, 274 patients underwent AVr for severe AI. Seventy-seven were performed in asymptomatic patients (Group I) and 197 were performed in symptomatic (Group II). Patients in Group I were younger (43.9 ± 15.0 vs 54.1 ± 15.5 years; P < 0.001) with a higher proportion of bicuspid valves (n = 40, 51.9% vs n = 68, 30.4%; P = 0.008). Group II had more patients with impaired left ventricular (LV; n = 36, 18.3% vs n = 5, 6.4%; P = 0.013). The mean follow-ups for Group I and Group II were 43.0 ± 34.0 and 61.3 ± 39.5 months, respectively. RESULTS: There was no in-hospital mortality. Overall, leaflet repair and reimplantation were higher in Group I (P = < 0.001 and P = 0.002, respectively), whereas subcommissural annuloplasty for tricuspid AV was higher in Group II (P = 0.002). Leaflet shaving and plication were performed in more patients in Group I (P = 0.002 for both). There was no difference in early complications, but during follow-up atrial fibrillation was more frequent in Group II (P = 0.03). There were 10 late cardiac deaths, all in Group II (P = 0.04). Overall, 10-year cardiac survival was better in Group I (100 vs 77.3 ± 8.6%) but not significant (P = 0.1). At 10 years, freedom from ≥ AI2+ was 63.2 ± 8.1 vs 56.4 ± 4.5% (P = 0.4), and freedom from AV reintervention was 81.8 ± 7.1 vs 89.0 ± 2.8% (P = 0.36), in Groups I and II, respectively. In the whole cohort, 10-year freedom from AV reintervention was greater in patients with an end-diastolic diameter of <60 mm (90.0 ± 7.6 vs 76.3 ± 5.5%; P = 0.003). Multivariate analysis identified increasing age as the only independent predictor of overall survival (P = 0.03). The incidence of valve-related complications was similar. CONCLUSION: In asymptomatic patients with severe degenerative AI, AVr is associated with excellent long-term outcomes, while symptoms are associated with reduced long-term survival. In dilated LV, freedom from reoperation is lower. If feasible, early AVr is recommended in experienced centres.

Influence of higher valve gradient on long-term outcome after aortic valve repair.

BACKGROUND: To evaluate the effect of higher post-operative valve gradient on freedom from valve re-intervention and death in patients undergoing aortic valve repair (AVr). METHODS: Patients who underwent AVr between March 1996 and June 2010 were divided into 2 groups: I: peak gradient (PG) <20 mmHg (n=358) and II: PG ≥20 mmHg (n=113). Age (53.6±16.0 vs. 50.6±16.4 years; P=0.08), impaired LV (n=44, 12.2% vs. n=12, 10.6%: P=0.73) as well as the body surface area (1.97 vs. 1.95 m(2); P=0.4) were similar. Pre-operative AI >2+ was greater in Group II compared to Group I (n=78, 69.0% vs. n=192, 53.6%; P=0.004). Patients in Group II had higher proportion of bicuspid valves (BV) (n=58, 51.3% vs. n=106, 29.6%; P=0.0001) and restrictive valves (n=34, 30.0% vs. n=52, 14.5%; P=0.0001) while Marfan patients were seen only in Group I (n=19; P=0.010). Mean follow-up for Group I and Group II was 123.1±89.7 and 147.1±108.0 months, respectively. RESULTS: In-hospital mortality was n=2 (0.5%) for Group I and none for Group II (P=1.0). Valve-sparing was higher in Group I (P=0.0001) but sub-commissural annuloplasty was similar (P=0.15). Shaving and/or decalcification was performed more in Group II (n=68, 60.1% vs. n=117, 32.6%; P=0.0001). Logistic regression analysis identified calcified, restrictive and bicuspid valves as independent predictors of PG ≥20 mmHg (P=0.04 for each). Predictors of re-operation were increased end-diastolic diameter (P=0.03) and younger age (P=0.007), but not PG ≥20 mmHg (P=0.98) (based on logistic regression). Overall 10-year cardiac survival and freedom from AV re-intervention was 82.3±4.6% vs. 89.5±4.2% (P=0.53) and 89.1±3.0% vs. 76.8±8.4% (P=0.02), in Group I and II, respectively (based on Kaplan-Meier analysis). Sub-group analysis showed that Group II patients requiring re-intervention (n=10) were younger (41.8±13.1 vs. 51.0±16.0 years; P=0.08) with similar proportion of bicuspid valves (n=6; 60%; P=0.74). The main reason for AV re-operation was aortic insufficiency (n=7) and AI + stenosis (n=3). CONCLUSIONS: Higher gradient after AVr is associated with a reduced freedom from AV re-intervention, especially in younger patients.

Interventions to promote informed consent for patients undergoing surgical and other invasive healthcare procedures.

BACKGROUND: Achieving informed consent is a core clinical procedure and is required before any surgical or invasive procedure is undertaken.  However, it is a complex process which requires patients be provided with information which they can understand and retain, opportunity to consider their options, and to be able to express their opinions and ask questions.  There is evidence that at present some patients undergo procedures without informed consent being achieved. OBJECTIVES: To assess the effects on patients, clinicians and the healthcare system of interventions to promote informed consent for patients undergoing surgical and other invasive healthcare treatments and procedures. SEARCH METHODS: We searched the following databases using keywords and medical subject headings: Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 5, 2012), MEDLINE (OvidSP) (1950 to July 2011), EMBASE (OvidSP) (1980 to July 2011) and PsycINFO (OvidSP) (1806 to July 2011). We applied no language or date restrictions within the search. We also searched reference lists of included studies. SELECTION CRITERIA: Randomised controlled trials and cluster randomised trials of interventions to promote informed consent for patients undergoing surgical and other invasive healthcare procedures. We considered an intervention to be intended to promote informed consent when information delivery about the procedure was enhanced (either by providing more information or through, for example, using new written materials), or if more opportunity to consider or deliberate on the information was provided. DATA COLLECTION AND ANALYSIS: Two authors assessed the search output independently to identify potentially-relevant studies, selected studies for inclusion, and extracted data. We conducted a narrative synthesis of the included trials, and meta-analyses of outcomes where there were sufficient data. MAIN RESULTS: We included 65 randomised controlled trials from 12 countries involving patients undergoing a variety of procedures in hospitals. Nine thousand and twenty one patients were randomised and entered into these studies. Interventions used various designs and formats but the main data for results were from studies using written materials, audio-visual materials and decision aids. Some interventions were delivered before admission to hospital for the procedure while others were delivered on admission.Only one study attempted to measure the primary outcome, which was informed consent as a unified concept, but this study was at high risk of bias.  More commonly, studies measured secondary outcomes which were individual components of informed consent such as knowledge, anxiety, and satisfaction with the consent process.  Important but less commonly-measured outcomes were deliberation, decisional conflict, uptake of procedures and length of consultation.Meta-analyses showed statistically-significant improvements in knowledge when measured immediately after interventions (SMD 0.53 (95% CI 0.37 to 0.69) I(2) 73%), shortly afterwards (between 24 hours and 14 days) (SMD 0.68 (95% CI 0.42 to 0.93) I(2) 85%) and at a later date (15 days or more) (SMD 0.78 (95% CI 0.50 to 1.06) I(2) 82%). Satisfaction with decision making was also increased (SMD 2.25 (95% CI 1.36 to 3.15) I(2) 99%) and decisional conflict was reduced (SMD -1.80 (95% CI -3.46 to -0.14) I(2) 99%). No statistically-significant differences were found for generalised anxiety (SMD -0.11 (95% CI -0.35 to 0.13) I(2) 82%), anxiety with the consent process (SMD 0.01 (95% CI -0.21 to 0.23) I(2) 70%) and satisfaction with the consent process (SMD 0.12 (95% CI -0.09 to 0.32) I(2) 76%). Consultation length was increased in those studies with continuous data (mean increase 1.66 minutes (95% CI 0.82 to 2.50) I(2) 0%) and in the one study with non-parametric data (control 8.0 minutes versus intervention 11.9 minutes, interquartile range (IQR) of 4 to 11.9 and 7.2 to 15.0 respectively). There were limited data for other outcomes.In general, sensitivity analyses removing studies at high risk of bias made little difference to the overall results.  AUTHORS' CONCLUSIONS: Informed consent is an important ethical and practical part of patient care.  We have identified efforts by researchers to investigate interventions which seek to improve information delivery and consideration of information to enhance informed consent.  The interventions used consistently improve patient knowledge, an important prerequisite for informed consent.  This is encouraging and these measures could be widely employed although we are not able to say with confidence which types of interventions are preferable. Our results should be interpreted with caution due to the high levels of heterogeneity associated with many of the main analyses although we believe there is broad evidence of beneficial outcomes for patients with the pragmatic application of interventions. Only one study attempted to measure informed consent as a unified concept.

Valve-preserving surgery on the bicuspid aortic valve.

Valve repair has emerged as an important intervention for the management of bicuspid aortic valve disease. This systematic review aims to assess the safety, efficacy and durability of bicuspid aortic valve repair. Initial searches yielded 682 abstracts, reduced by de-duplication to 370, of which 56 full papers were accessed and 30 met the inclusion criteria. Overall, 163 unique outcomes for bicuspid aortic valve-preserving surgery were reported on 280 occasions. Bicuspid aortic valve-preserving surgery exhibited low operative mortality (0.0-5.2%), excellent 5-year survival (82-100%) and 43-100% 5-year freedom from reoperation. Bicuspid aortic valve repair is safe and efficacious, but concerns regarding its durability necessitate further standardized outcome assessments.

Exploring the role of laparoscopic surgery in two-stage hepatectomy for bilobar colorectal liver metastases.

BACKGROUND: The role of laparoscopy in two-stage hepatectomy for bilobar colorectal liver metastases (CRLMs) has not yet been extensively investigated. PATIENTS AND METHODS: We reviewed a prospectively collected database of 302 consecutive patients undergoing laparoscopic liver resection at our institution between 2003 and 2011. RESULTS: Eight patients undergoing laparoscopic first/second-stage hepatectomy for bilobar CRLMs (male/female 6:2; median age, 64 years) were analyzed. The first stage consisted of laparoscopic clearance of the left lobe in all patients with no postoperative morbidity and mortality. Seven patients underwent portal vein embolization or ligation. The median interval between first- and second-stage hepatic resections was 89 days (range, 36-123 days). Second-stage hepatectomy with right lobar clearance (open, n=5; laparoscopic, n=2; laparoscopic to open, n=1) was associated with no mortality and an operative morbidity rate of 50%. Adhesions were judged to be minimal or absent during the second-stage procedure. Complications included intra-abdominal collection (n=2), bleeding requiring re-operation (n=1), and bile leak (n=1). R0 resection was obtained in 7 of 8 cases after first-stage resection and in 8 of 8 cases after second-stage resection. Three patients (38%) died from disease recurrence. Of the remaining 5 patients, 4 are disease-free at a median follow-up of 24 months (range, 9-27 months). CONCLUSIONS: The well-recognized advantages of laparoscopy may play a favorable role in the management of patients with bilobar CRLMs candidate for a two-stage resection. The first-stage laparoscopic clearance of the left lobe could progressively become the "gold standard." Laparoscopic second-stage hepatectomy should be limited to selected cases.

Midterm evaluation of biological prosthetic valves in the pulmonary position of grown-up patients.

OBJECTIVES: To examine the midterm clinical outcome of pulmonary valve replacement (PVR) with prosthetic valves. METHODS: We reviewed 37 consecutive patients who underwent PVR with biological prosthetic valves between September 1999 and June 2010. The median age was 22.6 years (range: 6 to 70 years; three children). The primary diagnosis was Tetralogy of Fallot in 20 patients (54%). Valve pathology was regurgitation in 27 patients (72.9%). Cardiac surgery had been previously performed in 35 patients (94.5%). The median size of the prosthesis was 25 mm (range: 21 to 31 mm). The median follow-up was 42 months (range: 1.2 to 129 months). RESULTS: There were no early valve-related deaths. Hospital mortality was 2.7% (n = 1) and no patient required early rereplacement of prosthesis. Two patients required permanent pacemaker insertion. During follow-up, there was no late death, reoperation for structural valve degeneration, or valve thrombosis. Only one patient required repeated operation for endocarditis at 37 months follow-up. The actuarial survival at 5 years was 95.1 ± 3.8%. Overall freedom from reoperation after PVR at 5 years was 93.0 ± 8.6%. At last follow-up, 34 patients (91.8%) were NYHA class I versus 20 patients (54%) preoperatively (p < 0.05). In the 35 surviving patients who did not undergo redo-PVR, there was no-mild regurgitation and the peak PV gradient was 20.4 ± 10.2 mm Hg (16.2 ± 9.3 mm Hg preoperatively). Thirty-two patients (91.4%) had good right ventricular function compared with 26 patients (74.2%) preoperatively. CONCLUSIONS: PVR with biological prosthetic valves can be performed with good midterm survival, functional status, and haemodynamics.

Outcome after redo-mitral valve replacement in adult patients: a 10-year single-centre experience.

The aim of this study was to investigate the overall outcome of adult patients undergoing redo-mitral valve replacement (redo-MVR) at our institution. Forty-nine patients (24 males) underwent redo-MVR with either bioprosthetic (n = 24) or mechanical valves (n = 25) between January 2000 and 2010. Median age of patients was 63 years (range 21-80 years), and the mean additive EuroSCORE was 12 ± 4. Median time to re-operation was 8.2 ± 6.6 years for first time redo-MVR and 6.4 ± 5.6 years for second-time redo-MVR. Indications included prosthetic endocarditis (n = 22), para-prosthetic leak (n = 12), structural valve degeneration (n = 8), prosthetic valve thrombosis (n = 6) and malignancy (n = 1). The mean follow-up was 47.5 ± 37.0 months (range 0.1-112.3 months). In-hospital mortality was 12% (n = 6). Mean hospital stay was 17 ± 11 days (range 8-50 days). Actuarial survival at 1 and 5 years was 81 ± 5% and 72 ± 6%, respectively. Three patients required re-intervention: two for prosthetic valve endocarditis and one for para-prosthetic leak. Multivariate analysis showed that overall survival was associated with the LVEF < 50% (P < 0.001), concomitant AVR (P < 0.001) and urgent surgery (P = 0.03).

Mitral valve repair for severe mitral regurgitation secondary to lone atrial fibrillation.

OBJECTIVES: Significant mitral regurgitation (MR) may arise from isolated annular dilatation secondary to lone atrial fibrillation (AF) and associated atrial remodelling. The aim of the present study is to assess the outcome of surgery for this condition. METHODS: Between November 2007 and July 2011, 20 patients underwent mitral valve (MV) repair for severe MR secondary to AF. The median age of patients was 77.5 years (45-82 years) and the mean pre-operative duration of AF was 84.6 ± 92 months. The left ventricle was moderately (ejection fraction 30-50%; n = 6) or severely (<30%; n = 1) impaired in seven patients pre-operatively. Mean logistic EuroSCORE was 8.1 ± 5.9 and mean follow-up was 18.0 ± 12.5 months. RESULTS: All operations were elective. Concomitant anti-arrhythmic procedures (maze procedure, pulmonary vein isolation) or left atrial (LA) appendage amputation were performed in all patients; tricuspid valve repair was undertaken in 12 patients and coronary artery bypass grafting in 2 patients. Ring annuloplasty was performed in all patients. The median ring size was 30 mm (range 24-36 mm). On-table transoesophageal echocardiography post-repair showed mild residual MR in two patients and no MR in the remainder. There were no cases of systolic anterior motion. There was one re-exploration for bleeding. No patients required haemofiltration or suffered from stroke and deep sternal wound infections. There was no in-hospital mortality. At discharge mean left ventricular (LV) end-diastolic diameter was 4.8 ± 0.7 cm compared with 5.6 ± 0.7 cm pre-operatively (P < 0.005), while mean LV end-systolic diameter was 3.2 ± 0.8 cm when compared with 4.0 ± 0.7 cm pre-operatively (P < 0.005). The mean LA size was 5.2 ± 1.0 cm when compared with 6.1 ± 1.6 cm pre-operatively (P = 0.03). There was mild MR in two patients, but none in the rest. The mean MV area was 3.0 ± 0.7 cm(2). The mean systolic pulmonary artery pressure was 40.4 ± 15.5 mmHg when compared with 54.1 ± 12.2 mmHg pre-operatively (P = 0.02). Seventeen patients (85%) were in NYHA class I/II at latest follow-up (P < 0.0001 vs pre-operatively). During follow-up, there were no thrombo-embolic complications, re-operation, endocarditis or deaths. CONCLUSIONS: MV annuloplasty for annular dilatation secondary to AF has a good mid-term outcome.

Aortic valve replacement in patients with previous coronary artery bypass grafting: 10-year experience.

UNLABELLED: OBJECTIVES; This study aimed to investigate the early and late outcomes of patients undergoing aortic valve replacement (AVR) with previous coronary artery bypass grafting (CABG) and patent grafts. METHODS: Between January 2000 and March 2010, 104 patients (87 males) with previous CABG ± concomitant surgery and patent grafts underwent AVR. The median age of the patients was 75 years (range: 37-90 years; inter-quartile range: 69-79 years) and the mean logistic EuroScore was 25.37 ± 16.8. The median time since the previous operation was 9 years (range 1-25; inter-quartile range: 7-14 years). The left internal mammary artery (LIMA) had been used in 75 patients (72.1%) and remained patent in 72 cases (96.0%). RESULTS: Thirty-day mortality was 7.7% (n = 8), which is less than the predicted mean logistic EuroScore. Isolated AVR was performed in 66 patients (63.5%). The LIMA was dissected and isolated (clamped or blocked with balloon) in 60 patients. The median hospital stay was 10 days (range: 4-183 days; inter-quartile range: 7-15.25 days). Nineteen patients (18.3%) had pulmonary complications, while 12 (11.5%) had acute kidney injury. Seven patients (6.7%) required permanent pacemaker. Six LIMAs (8.3%) were injured and repaired. Prolonged aortic cross-clamp (AXC) time (P = 0.038) and the presence of a previous LIMA graft (P = 0.045) were identified as independent predictors of 30-day mortality. The actuarial survival at 1 and 5 years was 89.4 ± 0.3 and 81.5 ± 0.5%, respectively. Perioperative intra-aortic balloon pump use (P = 0.036), prolonged AXC time (P = 0.004) and prolonged cardiopulmonary bypass time (P = 0.022) were associated with worse long-term overall survival on multivariate analysis. CONCLUSIONS: AVR post-CABG with patent grafts can be performed in high-risk patients with excellent short- and long-term outcomes and appears to be superior to published catheter-based interventions. In the absence of randomized trial data, we believe that open AVR remains the treatment of choice for aortic valve disease following prior CABG.

Management of median arcuate ligament syndrome in patients who require pancreaticoduodenectomy.

Pancreaticoduodenectomy is the standard treatment for localised neoplasms of the pancreatic head. The operation can be performed safely in specialist units but good outcome is compromised if postoperative blood flow to the liver and biliary tree is inadequate. Coeliac artery occlusion with blood supply to the liver arising from the superior mesenteric artery via the gastroduodenal artery is difficult to recognise, especially intraoperatively. Recognition of absent hepatic artery pulsation after occlusion of the gastroduodenal artery opens a dilemma: should the resection be abandoned or should vascular reconstruction be undertaken, adding risk to an already complex procedure? We describe two cases with a resectable pancreatic endocrine tumour in which coeliac artery occlusion caused by median arcuate ligament compression was identified from cross-sectional imaging and reconstructions. We highlight two different strategies to correct the vascular insufficiency and allow safe pancreatic resection.

A case of Tropheryma whipplei infective endocarditis of the aortic and mitral valves in association with psoriatic arthritis and lumbar discitis.

Whipple's disease is a chronic condition that is characterized by diarrhea, weight loss and arthropathy, and caused by infection with the fastidious bacterium Tropheryma whipplei. Although once rare, Whipple's disease is being increasingly described owing mainly to advances in molecular genetics and an improved isolation of the organism. Whilst cardiac Whipple's disease occurs less commonly, especially in the absence of gastrointestinal symptoms, it has become apparent that some cases of culture-negative endocarditis may well be attributable to T. whipplei. The case is reported of a patient with Whipple's disease endocarditis in association with psoriatic arthritis and lumbar discitis.

Systematic review: quality of life after treatment for upper gastrointestinal cancer.

PURPOSE OF REVIEW: The aim of this systematic review is to scrutinize and summarize the design, conduct and reporting standards of articles recently published describing health-related quality of life (HRQL) outcomes of treatment of upper gastrointestinal cancer. RECENT FINDINGS: Some 2312 abstracts were published between January and July 2009 and initial elimination of papers reduced this number to 22 articles. Of these, 17 were judged to have robust HRQL methodology, but a further seven were excluded due to a high risk of bias in the study design. Ten articles (four randomized trials) were finally included in the review. Studies in curative treatments for oesophagogastric cancer show that surgery and chemoradiation therapy has a major short-term detrimental effect on HRQL, but recovery occurs within 6 months in long-term survivors but those not achieving a survival benefit report very poor HRQL. In advanced oesophageal cancer, 18 mm self-expandable metal stents and nonstent therapies lead to better short-term HRQL scores than nonexpandable stents and are the recommended standard of care. A small survival advantage and improved HRQL is conferred by adjuvant and palliative gemcitabine chemotherapy in patients with pancreatic cancer. SUMMARY: This review identified few well-designed studies that also included a robust assessment of HRQL. High-quality trials with reliable HRQL methods are required for outcomes to inform health policy and clinical decision-making.