Armando Sabbatini

Peak Oxygen Consumption During Cardiopulmonary Exercise Test Improves Risk Stratification in Candidates to Major Lung Resection

BACKGROUND The objective of this investigation was to assess the association of peak oxygen consumption (Vo(2)) with postoperative outcome in a prospective cohort of patients undergoing major lung resection for the treatment of lung cancer. METHODS Preoperative symptom-limited cardiopulmonary exercise testing (CPET) performed using cycle ergometry was conducted in 204 consecutive patients who had undergone pulmonary lobectomy or pneumonectomy. Peak Vo(2) was tested for possible association with postoperative cardiopulmonary complications and mortality. Logistic regression analysis, validated by a bootstrap analysis, was used to adjust for the effect of other perioperative factors. The role of peak Vo(2) in stratifying the surgical risk was further assessed in different groups of patients subdivided according to their cardiorespiratory status. RESULTS Logistic regression showed that peak Vo(2) was an independent and reliable predictor of pulmonary complications (p = 0.04). All six deaths occurred in patients with a peak Vo(2) of < 20 mL/kg/min (four deaths in patients with a peak Vo(2) of < 12 mL/kg/min). The mortality rate in this high-risk group was 10-fold higher (4 of 30 patients; 13%) compared to those with higher peak Vo(2) (p = 0.006). Compared to patients with a peak Vo(2) of > 20 mL/kg/min, those with a peak Vo(2) of < 12 mL/kg/min had 5-fold, 8-fold, 5-fold, and 13-fold higher rates, respectively, of total cardiopulmonary complications pulmonary complications, cardiac complications, and mortality. CONCLUSIONS The present study supports a more liberal use of CPET before lung resection compared to the current guidelines since this test can help in stratifying the surgical risk and optimizing perioperative care.

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.

Recalibration of the Revised Cardiac Risk Index in Lung Resection Candidates

BACKGROUND The revised cardiac risk index (RCRI) has been proposed as a tool for cardiac risk stratification before lung resection. However, the RCRI was originally developed from a generic surgical population including a small group of thoracic patients. The objective of this study was to recalibrate the RCRI in candidates for major lung resections to provide a more specific instrument for cardiac risk stratification. METHODS One thousand six hundred ninety-six patients who underwent lobectomy (1,426) or pneumonectomy (270) in two centers between the years of 2000 and 2008 were analyzed. Stepwise logistic regression and bootstrap analyses were used to recalibrate the six variables comprising the RCRI. The outcome variable was occurrence of major cardiac complications (cardiac arrest, complete heart block, acute myocardial infarction, pulmonary edema, or cardiac death during admission). Only those variables with a probability of less than 0.1 in more than 50% of bootstrap samples were retained in the final model and proportionally weighted according to their regression estimates. RESULTS The incidence of major cardiac morbidity was 3.3% (57 patients). Four of the six variables present in the RCRI were reliably associated with major cardiac complications: cerebrovascular disease (1.5 points), cardiac ischemia (1.5 points), renal disease (1 point), and pneumonectomy (1.5 points). Patients were grouped into four classes according to their recalibrated RCRI, predicting an incremental risk of cardiac morbidity (p < 0.0001). Compared with the traditional RCRI, the recalibrated score had a higher discrimination (c indexes, 0.72 versus 0.62; p = 0.004). CONCLUSIONS The recalibrated RCRI can be reliably used as a first-line screening instrument during cardiologic risk stratification for selecting those patients needing further cardiologic testing from those who can proceed with pulmonary evaluation without any further cardiac tests.

Pleural tent after upper lobectomy: a randomized study of efficacy and duration of effect

BACKGROUND The object of this study was to assess the efficay and maximum duration of effect of the pleural tent in reducing the incidence of air leak after upper lobectomy. METHODS Two hundred patients who underwent upper lobectomy were prospectively randomized into two groups: 100 patients who underwent an upper lobectomy and a pleural tent procedure (group 1; tented patients) and 100 patients who underwent only an upper lobectomy and not a pleural tent procedure (group 2; untented patients). The preoperative, operative, and postoperative characteristics of both groups were compared. Then multivariate analyses were used to identify factors predictive of prolonged air leaks and their duration. The reduction of incidences of air leak in the two groups was subsequently compared during successive postoperative periods. RESULTS No differences were detected between the two groups in terms of preoperative and operative characteristics. A significant reduction occurred in group 1 patients for the mean duration of air leak in days (2.5 vs 7.2 days; p < 0001), the number of days a chest tube was required (7.0 vs 11.2 days; p < 0.0001), the length of postoperative hospital stay in days (8.2 vs 11.6 days; p < 0.0001), and the hospital stay cost per patient (4,110 dollars vs 5,805 dollars; p < 0.0001). Logistic regression analyses showed that not having undergone a pleural tent procedure was the most significant predictive factor of the occurrence and duration of prolonged air leaks. A greater reduction in the duration of air leaks was observed before postoperative day 4 in group 1, and logistic regression analysis showed that having undergone a pleural tent procedure was the most significant predictive factor of air leaks that persisted for less than 4 days. CONCLUSIONS Pleural tenting after upper lobectomy was a safe procedure that reduced the duration of air leaks and the hospital stay costs. The benefit from that procedure was achieved before postoperative day 4.

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.

A Scoring System to Predict the Risk of Prolonged Air Leak After Lobectomy

BACKGROUND Prolonged air leak (PAL) remains a frequent complication after lung resection. Perioperative preventative strategies have been tested, but their efficacy is often difficult to interpret due to heterogeneous inclusion criteria. The objective of this study was to develop and validate a practical score to stratify the risk of PAL after lobectomy. METHODS Six hundred fifty-eight consecutive patients were submitted to pulmonary lobectomy (2000 to 2008) in center A and were used to develop the risk-adjusted score predicting the incidence of PAL (> 5 days). Exclusion criteria were chest wall resection and postoperative assisted mechanical ventilation. No sealants, pleural tent, or buttressing material were used. To build the aggregate score numeric variables were categorized by receiver operating curve analysis. Variables were screened by univariate analysis and then used in stepwise logistic regression analysis (validated by bootstrap). The scoring system was developed by proportional weighing of the significant predictor estimates and was validated on patients operated on in a different center (center B). RESULTS The incidence of PAL in the derivation set was 13% (87 of 658 cases). Predictive variables and their scores were the following: age greater than 65 years (1 point); presence of pleural adhesions (1 point); forced expiratory volume in one second less than 80% (1.5 points); and body mass index less than 25.5 kg/m(2) (2 points). Patients were grouped into 4 risk classes according to their aggregate scores, which were significantly associated with incremental risk of PAL in the validation set of 233 patients. CONCLUSIONS The developed scoring system reliably predicts incremental risk of PAL after pulmonary lobectomy. Its use may help in identifying those high-risk patients in whom to adopt intraoperative prophylactic strategies; in developing inclusion criteria for future randomized clinical trials on new technologies aimed at reducing or preventing air leak; and for patient counseling.

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.

Performance at Preoperative Stair-Climbing Test Is Associated With Prognosis After Pulmonary Resection in Stage I Non-Small Cell Lung Cancer

BACKGROUND This investigation evaluated whether the performance at a preoperative symptom-limited stair-climbing test was a prognostic factor in resected pathologic stage I non-small cell lung cancer (NSCLC). METHODS Observational analysis was performed on a prospective database that included 296 patients who underwent pulmonary lobectomy for pathologic stage T1 N0 or T2 N0 NSCLC (2000 to 2008). Patients who received induction chemotherapy were excluded. Survival was calculated by the Kaplan-Meyer method. The log-rank test was used to assess differences in survival between groups. The relationships between survival and baseline and clinical variables were determined by Cox multivariate analyses. RESULTS Median follow-up was 43 months. The best cutoff associated with prognosis was an 18-meter stair climb. Median (months) survival and 5-year survival of patients who climbed more than 18 meters were significantly longer than those who climbed less than 18 meters (97 vs 74; 77% vs 54%, p=0.001). Cox regression model (hazard ratio) showed that climbing more than 18 meters (0.5; p=0.003), diffusion capacity of the lung for carbon monoxide (0.98; p=0.02), and pT stage (1.8; p=0.02) were independent prognostic factors. Patients who climbed less than 18 meters had increased deaths from cancer (24% vs 15%, p=0.1) or other causes (19% vs 9%, p=0.02). CONCLUSIONS Preoperative cardiopulmonary fitness is a significant prognostic factor in patients after resection for early-stage NSCLC. Interventions aimed at improving exercise tolerance can be useful to improve long-term prognosis after NSCLC operations.

Pleural tent after upper lobectomy: a prospective randomized study

BACKGROUND The aim of the present study was to assess the cost/efficacy of the pleural tent procedure after upper lobectomy. METHODS A prospective randomized analysis was performed on 50 patients submitted to upper lobectomy and divided into two groups: group 1 (25 patients) with pleural tent; group 2 (25 patients) without pleural tent. RESULTS The univariate comparison between the two groups did not show any significant difference in terms of age, gender, spirometry, smoking history, chronic obstructive pulmonary disease index, side of tumor, arterial oxygen tension, arterial carbon dioxide tension, size and location of tumor, presence of pleural adhesions, length of the stapled parenchyma, and operative time. Pleural tent significantly reduced the days of postoperative air leak (1.2 versus 5.8, p = 0.01), chest tubes (5.4 versus 10.4, p = 0.01), and hospital stay (6.9 versus 10.8, p = 0.01). Moreover, no difference was noted between the two groups in terms of pleural effusion in the first postoperative 48 hours, need of postoperative blood transfusion, and occurrence of other complications. CONCLUSIONS Pleural tenting after upper lobectomy is a safe and effective procedure and its routine use is warranted.

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.