Francesco Xiumé

Evaluation of a new chest tube removal protocol using digital air leak monitoring after lobectomy: a prospective randomised trial

BACKGROUND The objective of this randomised trial was to assess the effectiveness of a new fast-track chest tube removal protocol taking advantage of digital monitoring of air leak compared to a traditional protocol using visual and subjective assessment of air leak (bubbles). METHODS One hundred and sixty-six patients submitted to pulmonary lobectomy for lung cancer were randomised in two groups with different chest tube removal protocols: (1) in the new protocol, chest tube was removed based on digitally recorded measurements of air leak flow; (2) in the traditional protocol, the chest tube removal was based on an instantaneous assessment of air leak during daily rounds. The two groups were compared in terms of chest tube duration, hospital stay and costs. RESULTS The two groups were well matched for several preoperative and operative variables. Compared to the traditional protocol, the new digital recording protocol showed mean reductions in chest tube duration (p=0.0007), hospital stay (p=0.007) of 0.9 day, and a mean cost saving of euro 476 per patient (p=0.008). In the new chest tube removal protocol, 51% of patients had their chest tube removed by the second postoperative day versus only 12% of those in the traditional protocol. CONCLUSIONS The application of a chest tube removal protocol using a digital drainage unit featuring a continuous recording of air leak was safe and cost effective. Although future studies are warranted to confirm these results in other settings, the use of this new protocol is now routinely applied in our practice.

Predictors of early morbidity after major lung resection in patients with and without airflow limitation

BACKGROUND The aim of the present study was to identify predictors of morbidity after major lung resection for non-small cell lung carcinoma in patients with forced expiratory volume in 1 second (FEV1) greater than or equal to 70% of predicted and in those with FEV1 less than 70% of predicted. METHODS Five hundred forty-four patients who underwent lobectomy or pneumonectomy from 1993 through 2000 were retrospectively analyzed. The patients were divided into two groups: group A (450 cases), with FEV1 greater than or equal to 70%, and group B (94 cases), with FEV1 less than 70%. Differences between complicated and uncomplicated patients were tested within each group. RESULTS Morbidity rate was not significantly different between group A and group B (20.4% and 24.5%, respectively; p = 0.4). In group A, multivariate analysis showed that predicted postoperative FEV1 was the only significant independent predictor of complications. In group B, no significant predictor was identified. CONCLUSIONS In patients with preoperative FEV1 less than 70% of predicted, predicted postoperative FEV1 was not predictive of postoperative morbidity. Thus, predicted postoperative FEV1 should not be used alone as a selection criteria for operation in these high-risk patients.

Quality of life in the elderly after major lung resection for lung cancer

The objective of this study was to assess the residual quality of life (QoL) in elderly patients submitted to major lung resection for lung cancer. From July 2004 through August 2007 a total of 218 patients, 85 of whom were elderly (70 years), had complete preoperative and postoperative (3 months) quality of life measures assessed by the Short Form 36v2 health survey. QoL scales were compared between elderly and younger patients. Furthermore, limited to the elderly group, we compared the preoperative with the postoperative SF36v2 measures and the physical component summary (PCS) and mental component summary (MCS) scores between high-risk patients and low-risk counterparts. The postoperative SF36 PCS (50.3 vs. 50, P=0.7) and MCS (50.6 vs. 49, P=0.2) and all SF36 domains did not differ between elderly and younger patients. Within the elderly, the QoL returns to the preoperative values three months after the operation. Moreover, we did not find any significant differences between elderly higher-risk patients and their lower-risk counterparts postoperatively. The information that residual QoL in elderly patients will be similar to the one experienced by younger and fitter individuals may help them in their decision to proceed with surgery.

Does chronic obstructive pulmonary disease affect postoperative quality of life in patients undergoing lobectomy for lung cancer? A case-matched study

BACKGROUND The objective of this investigation was to assess the quality of life (QoL) before and after pulmonary lobectomy in patients with chronic obstructive pulmonary disease (COPD) and to compare these values with a case-matched population of patients with normal respiratory function. METHODS This is an observational analysis performed on a prospective dataset of 220 consecutive patients submitted to pulmonary lobectomy for lung cancer (2006-2008). Patients submitted to extended procedures (chest wall resection and superior sulcus) were excluded from the analysis. Pre- and postoperative (3 months) QoL were assessed in all patients through the administration of the Short Form 36v2 (SF36v2) health survey, a generic QoL instrument assessing eight health physical and mental concepts. Propensity score was used to match COPD patients (according to the NHLBI/WHO Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria: forced expiratory volume in 1s/forced expiratory vital capacity (FEV1/FVC) ratio <0.7 and FEV1 <80%) with counterparts without COPD. QoL scales were compared between the two matched groups by means of the Mann-Whitney test. RESULTS Propensity score yielded 50 well-matched pairs of patients with and without COPD. Compared with non-COPD patients, those with COPD had a threefold higher rate of cardiopulmonary morbidity (14 cases vs 5 cases, 28% vs 10%, p=0.04), lower reduction in FEV1 (6% vs 13%, p=0.0002), but lower residual postoperative FEV1 values (62% vs 74%, p<0.0001). Postoperative carbon monoxide lung diffusion capacity (DLCO) (69% vs 65%, p=0.1) and VO(2 max) (15.3 ml kg(-1)min(-1) vs 14.3 ml kg(-1)min(-1)p=0.4) values were similar between the groups. Although most of the preoperative and postoperative QoL domains in both groups were reduced compared with normal population (<50), we were not able to find differences between the groups in any of the preoperative and postoperative physical and mental QoL scales. CONCLUSIONS The evidence of an acceptable QoL in COPD patients may help both patients and physicians in the surgical decision-making process in the face of high rates of complications.

Minute Ventilation-to-Carbon Dioxide Output ( V ˙e/ V ˙co2) Slope Is the Strongest Predictor of Respiratory Complications and Death After Pulmonary Resection

BACKGROUND This study assessed whether the minute ventilation-to-carbon dioxide output (VE/VCO2) slope, a measure of ventilatory efficiency routinely measured during cardiopulmonary exercise testing (CPET), is an independent predictor of respiratory complications after major lung resections. METHODS Prospective observational analysis was performed on 225 consecutive candidates after lobectomy (197 patients) or pneumonectomy (28 patients) from 2008 to 2010. Inoperability criteria were peak oxygen consumption (VO2) of less than 10 mL/kg/min in association with predicted postoperative forced expiratory volume in 1 second of less than 30% and diffusion capacity of the lung for carbon monoxide of less than 30%. All patients performed a symptom-limited CPET on cycle ergometer. Respiratory complications (30 days or in-hospital) were prospectively recorded: pneumonia, atelectasis requiring bronchoscopy, respiratory failure on mechanical ventilation exceeding 48 hours, adult respiratory distress syndrome, pulmonary edema, and pulmonary embolism. Univariable and multivariable regression analyses were used to identify independent predictors of respiratory complications. RESULTS Cardiopulmonary morbidity and mortality rates were 23% (51 patients) and 2.2% (5 patients). The 25 patients with respiratory complications had a significantly higher VE/VCO2 slope than those without complications (34.8 vs 30.9, p=0.001). Peak VO2 was not associated with respiratory complications. Logistic regression and bootstrap analyses showed that, after adjusting for other baseline and perioperative variables, the strongest predictor of respiratory complications was VE/VCO2 slope (regression coefficient, 0.09; bootstrap frequency, 89%; p=0.004). Patients with a VE/VCO2 slope exceeding 35 had a higher incidence of respiratory complications (22% vs 7.6%, p=0.004) and mortality (7.2% vs. 0.6%, p=0.01). CONCLUSIONS VE/VCO2 slope is a better predictor of respiratory complications than peak VO2. This inexpensive and operator-independent variable should be considered in the clinical practice to refine operability selection criteria.

Peak Oxygen Consumption Measured during the Stair-Climbing Test in Lung Resection Candidates

Background: The stair-climbing test is commonly used in the preoperative evaluation of lung resection candidates, but it is difficult to standardize and provides little physiologic information on the performance. Objective: To verify the association between the altitude and the VO2peak measured during the stair-climbing test. Methods: 109 consecutive candidates for lung resection performed a symptom-limited stair-climbing test with direct breath-by-breath measurement of VO2peak by a portable gas analyzer. Stepwise logistic regression and bootstrap analyses were used to verify the association of several perioperative variables with a VO2peak <15 ml/kg/min. Subsequently, multiple regression analysis was also performed to develop an equation to estimate VO2peak from stair-climbing parameters and other patient-related variables. Results: 56% of patients climbing <14 m had a VO2peak <15 ml/kg/min, whereas 98% of those climbing >22 m had a VO2peak >15 ml/kg/min. The altitude reached at stair-climbing test resulted in the only significant predictor of a VO2peak <15 ml/kg/min after logistic regression analysis. Multiple regression analysis yielded an equation to estimate VO2peak factoring altitude (p < 0.0001), speed of ascent (p = 0.005) and body mass index (p = 0.0008). Conclusions: There was an association between altitude and VO2peak measured during the stair-climbing test. Most of the patients climbing more than 22 m are able to generate high values of VO2peak and can proceed to surgery without any additional tests. All others need to be referred for a formal cardiopulmonary exercise test. In addition, we were able to generate an equation to estimate VO2peak, which could assist in streamlining the preoperative workup and could be used across different settings to standardize this test.

Efficacy of anterior fissureless technique for right upper lobectomies: a case-matched analysis §

OBJECTIVE In pulmonary lobectomy, the dissection through the fissure to gain access to the pulmonary artery may increase the risk of postoperative air leak. For several anatomic reasons, this risk is especially high after right upper lobectomies (RULs). The objective of this investigation was to verify the efficacy of an anterior fissureless lobectomy (FL) technique in reducing the incidence and duration of air leak after RUL. METHODS An observational analysis was performed of 206 consecutive patients (2002-2009) submitted to RUL for non-small-cell lung cancer. Operations were performed through a muscle-sparing lateral thoracotomy. Patients with completely developed fissures were excluded. No sealants or buttressing material were used. For group TR (traditional resection, 146 patients), RUL was performed by traditional intra-fissure dissection of the pulmonary artery; for group FL (60 patients), RUL was carried out by fissureless division of all hilar vascular structures. Several perioperative variables were used in identifying propensity score-matched pairs of patients undergoing traditional and fissureless lobectomies. The matched groups were then compared in terms of incidence of prolonged air leak, air leak duration, operation time, chest tubes duration, hospital stay and costs. RESULTS Propensity score analysis yielded 58 well-matched pairs of patients operated by traditional or fissureless RUL. Compared to those in the traditional group, patients in group FL had a mean reduction in air leak duration, duration of chest tube and postoperative stay of 1.1, 1.4 and 1.2 days, respectively. This translated into an average hospital cost saving of 569 € per patient. CONCLUSIONS The use of an anterior fissureless technique during RUL reduced the duration of air leak and hospital costs without increasing the surgical time. Given its simplicity and efficacy, we regard it as a useful tool for implementing fast-tracking policies and cutting hospital costs.

Prospective external convergence evaluation of two different quality-of-life instruments in lung resection patients

OBJECTIVES The interpretation of studies on quality of life (QoL) after lung surgery is often difficult owing to the use of multiple instruments with inconsistent scales and metrics. Although a more standardized approach would be desirable, the most appropriate instrument to be used in this setting is still largely undefined. The aim of the study was to assess the respective ability of two validated QoL instruments (European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30/L13 and Short Form (36) Health Survey (SF-36)) to detect perioperative changes in QoL of patients submitted to pulmonary resection for non-small-cell lung cancer (NSCLC). METHODS A prospective study on 33 consecutive patients (May 2009-December 2009) was submitted to pulmonary resection. All patients completed both EORTC QLQ-C30 with lung module 13 and SF-36 pre- and postoperatively (3 months). Preoperative changes of all SF-36 and EORTC scales were assessed by using the Cohens effect-size method. External convergence between different instruments (SF-36 vs EORTC) was assessed by measuring the correlation of scales evaluating the same concepts (physical, psychosocial, and emotional). The correlation coefficients between standardized perioperative changes (effect sizes) of objective functional parameters (forced expiratory volume in 1s (FEV1) and diffusion lung capacity for carbon monoxide (DLCO)) and SF-36 or EORTC scales were also investigated. RESULTS A poor correlation (r < 0.5) was detected between most of the scales of the two instruments measuring the same QoL concepts, indicating that they may be complementary in investigating different aspects of QoL. Only the SF-36 and EORTC social functioning scales and the SF-36 mental health and EORTC emotional functioning scales had a correlation coefficient >0.5. In general, EORTC was more sensitive in detecting physical or emotional declines but was more conservative in detecting improvements. Both SF-36 and EORTC showed poor correlations (r < 0.5) between perioperative changes in QoL and FEV1 or DLCO, confirming that objective parameters cannot be surrogates to the subjective perception of QoL. In particular, there was a poor correlation between perceived changes in dyspnea and objective changes in FEV1 or DLCO. CONCLUSIONS EORTC behaved similarly to SF-36 in assessing perioperative changes in generic QoL scales, but, with the use of its lung module, provided a more detailed evaluation of specific symptoms. For this reason, EORTC should be regarded as the instrument of choice for measuring QoL in the thoracic surgery setting.

Short-term perioperative treatment with ambroxol reduces pulmonary complications and hospital costs after pulmonary lobectomy: a randomized trial

OBJECTIVE To assess in a randomized clinical trial the influence of perioperative short-term ambroxol administration on postoperative complications, hospital stay and costs after pulmonary lobectomy for lung cancer. METHODS One hundred and forty consecutive patients undergoing lobectomy for lung cancer (April 2006-November 2007) were randomized in two groups. Group A (70 patients): ambroxol was administered by intravenous infusion in the context of the usual therapy on the day of operation and on the first 3 postoperative days (1000 mg/day). Group B (70 patients): fluid therapy only without ambroxol. Groups were compared in terms of occurrence of postoperative complications, length of stay and costs. RESULTS There were no dropouts from either group and no complications related to treatment. The two groups were well matched for perioperative and operative variables. Compared to group B, group A (ambroxol) had a reduction of postoperative pulmonary complications (4 vs 13, 6% vs 19%, p=0.02), and unplanned ICU admission/readmission (1 vs 6, 1.4% vs 8.6%, p=0.1) rates. Moreover, the postoperative stay and costs were reduced by 2.5 days (5.6 vs 8.1, p=0.02) and 2765 Euro (2499 Euro vs 5264 Euro, p=0.04), respectively. CONCLUSIONS Short-term perioperative treatment with ambroxol improved early outcome after lobectomy and may be used to implement fast-tracking policies and cut postoperative costs. Nevertheless, other independent trials are needed to verify the effect of this treatment in different settings.

Development of a patient-centered aggregate score to predict survival after lung resection for non–small cell lung cancer

OBJECTIVE The objective of this analysis was to develop a survival aggregate score (SAS), including objective and subjective patient-based parameters, and assess its prognostic role after major anatomic resection for non-small cell lung cancer. METHODS A total of 245 patients underwent major lung resections for non-small cell lung cancer with preoperative evaluation of quality of life (Short-Form 36v2 survey) and complete follow-up. The Cox multivariable regression and bootstrap analyses were used to identify prognostic factors of overall servival, which were weighted to construct the scoring system and summed to generate the SAS. RESULTS Cox regression analysis showed that the factors negatively associated with overall survival and used to construct the score were 36-item short-form health survey physical component summary score less than 50 (hazard ratio [HR], 1.7; P = .008), aged older than 70 years (HR, 1.9; P = .002), and carbon monoxide lung diffusion capacity less than 70% (HR, 1.7; P = .01). Patients were grouped into 4 risk classes according to their SAS. The 5-year overall survival was 78% in class SAS0, 59% in class SAS1, 42% in class SAS2, and 14% in class SAS3 (log-rank test, P < .0001). SAS maintained its association with overall survival in patients with stages pT1 (log-rank test, P = .01), pT2 (log-rank test, P = .02), or pT3-4 (log-rank test, P = .001), and in those with stages pN0 (log-rank test, P = .0005) or pN1-2 (log-rank test, P = .02). The 5-year cancer-specific survival was 83% in class SAS0, 71% in class SAS1, 63% in class SAS2, and 17% in class SAS3 (log-rank test, P < .0001). CONCLUSIONS This system may be used to refine stratification of prognosis for clinical and research purposes.