Transcatheter or surgical aortic valve implantation: 10-year outcomes of the NOTION trial.

BACKGROUND AND AIMS: Transcatheter aortic valve implantation (TAVI) has become a viable treatment option for patients with severe aortic valve stenosis across a broad range of surgical risk. The Nordic Aortic Valve Intervention (NOTION) trial was the first to randomize patients at lower surgical risk to TAVI or surgical aortic valve replacement (SAVR). The aim of the present study was to report clinical and bioprosthesis outcomes after 10 years. METHODS: The NOTION trial randomized 280 patients to TAVI with the self-expanding CoreValve (Medtronic Inc.) bioprosthesis (n = 145) or SAVR with a bioprosthesis (n = 135). The primary composite outcome was the risk of all-cause mortality, stroke, or myocardial infarction. Bioprosthetic valve dysfunction (BVD) was classified as structural valve deterioration (SVD), non-structural valve dysfunction (NSVD), clinical valve thrombosis, or endocarditis according to Valve Academic Research Consortium-3 criteria. Severe SVD was defined as (i) a transprosthetic gradient of 30 mmHg or more and an increase in transprosthetic gradient of 20 mmHg or more or (ii) severe new intraprosthetic regurgitation. Bioprosthetic valve failure (BVF) was defined as the composite rate of death from a valve-related cause or an unexplained death following the diagnosis of BVD, aortic valve re-intervention, or severe SVD. RESULTS: Baseline characteristics were similar between TAVI and SAVR: age 79.2 ± 4.9 years and 79.0 ± 4.7 years (P = .7), male 52.6% and 53.8% (P = .8), and Society of Thoracic Surgeons score < 4% of 83.4% and 80.0% (P = .5), respectively. After 10 years, the risk of the composite outcome all-cause mortality, stroke, or myocardial infarction was 65.5% after TAVI and 65.5% after SAVR [hazard ratio (HR) 1.0; 95% confidence interval (CI) 0.7-1.3; P = .9], with no difference for each individual outcome. Severe SVD had occurred in 1.5% and 10.0% (HR 0.2; 95% CI 0.04-0.7; P = .02) after TAVI and SAVR, respectively. The cumulative incidence for severe NSVD was 20.5% and 43.0% (P < .001) and for endocarditis 7.2% and 7.4% (P = 1.0) after TAVI and SAVR, respectively. No patients had clinical valve thrombosis. Bioprosthetic valve failure occurred in 9.7% of TAVI and 13.8% of SAVR patients (HR 0.7; 95% CI 0.4-1.5; P = .4). CONCLUSIONS: In patients with severe AS and lower surgical risk randomized to TAVI or SAVR, the risk of major clinical outcomes was not different 10 years after treatment. The risk of severe bioprosthesis SVD was lower after TAVR compared with SAVR, while the risk of BVF was similar.

Eight-year outcomes for patients with aortic valve stenosis at low surgical risk randomized to transcatheter vs. surgical aortic valve replacement.

AIMS: The aims of the study were to compare clinical outcomes and valve durability after 8 years of follow-up in patients with symptomatic severe aortic valve stenosis at low surgical risk treated with either transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR). METHODS AND RESULTS: In the NOTION trial, patients with symptomatic severe aortic valve stenosis were randomized to TAVI or SAVR. Clinical status, echocardiography, structural valve deterioration, and failure were assessed using standardized definitions. In total, 280 patients were randomized to TAVI (n = 145) or SAVR (n = 135). Baseline characteristics were similar, including mean age of 79.1 ± 4.8 years and a mean STS score of 3.0 ± 1.7%. At 8-year follow-up, the estimated risk of the composite outcome of all-cause mortality, stroke, or myocardial infarction was 54.5% after TAVI and 54.8% after SAVR (P = 0.94). The estimated risks for all-cause mortality (51.8% vs. 52.6%; P = 0.90), stroke (8.3% vs. 9.1%; P = 0.90), or myocardial infarction (6.2% vs. 3.8%; P = 0.33) were similar after TAVI and SAVR. The risk of structural valve deterioration was lower after TAVI than after SAVR (13.9% vs. 28.3%; P = 0.0017), whereas the risk of bioprosthetic valve failure was similar (8.7% vs. 10.5%; P = 0.61). CONCLUSIONS: In patients with severe aortic valve stenosis at low surgical risk randomized to TAVI or SAVR, there were no significant differences in the risk for all-cause mortality, stroke, or myocardial infarction, as well as the risk of bioprosthetic valve failure after 8 years of follow-up. CLINICAL TRIAL REGISTRATION: URL: http://www.ClinicalTrials.gov. Unique identifier: NCT01057173.

Heart Team therapeutic decision-making and treatment in severe aortic valve stenosis.

Objectives After transcatheter aortic valve implantation (TAVI) has been available for high-risk patients with severe aortic valve stenosis (AVS), the decision-making of the Heart Team (HT) has not been examined. Design All adult patients with severe AVS referred to a large tertiary medical centre in 2011 were prospectively included. Multivariate regression analysis identified independent factors associated with treatment decisions. Results A total of 487 patients were included (mean age: 75 years, NYHA class III-IV: 47%). The HT proposed medical therapy (MT) in 35 (7%), TAVI in 60 (12%), and surgical aortic valve replacement (SAVR) in 392 (81%) of patients. In patients referred to intervention, TAVI compared with SAVR patients were older (OR = 1.17 per year, 95% CI 1.09-1.26; p < 0.01) with more previous coronary artery bypass surgery (OR = 385, 79-2738; p < 0.01), obesity (OR = 4.69, 1.51-13.77; p < 0.01), and chronic obstructive pulmonary disease (COPD) (OR = 3.66, 1.21-10.75; p = 0.02). MT patients compared with patients referred to any intervention were older, had a higher prevalence of COPD, peripheral arterial disease, previous myocardial infarction, and cerebrovascular disease. Conclusions The HT proposed intervention in 93% of patients with severe AVS despite high age, advanced symptoms and a high burden of co-morbidity. TAVI was reserved for older patients particularly with previous CABG.

Renal replacement therapy after cardiac surgery; renal function recovers.

OBJECTIVES: To assess renal outcome in patients discharged from hospital following cardiac surgery-associated acute kidney injury (CSA-AKI) with need for renal replacement therapy. DESIGN: In April 2012 we conducted a cross-sectional study of patients treated with renal replacement therapy following cardiac surgery during 2008-2010. We included all adult patients with a pre-operative serum creatinine (sCr) < 200 µM, surviving to discharge. Primary endpoint was use of renal replacement therapy after hospital discharge; secondary endpoint was a sCr > 200 µM at the time of follow-up. RESULTS: We reviewed the records of 3828 patients receiving cardiac surgery in the defined period. A total of 107 adult patients with sCr concentrations < 200 µM were treated with post-operative renal replacement therapy of whom 70 survived to discharge. Fifty-six patients were alive at follow-up and none had required renal replacement therapy after initial discharge. Median sCr concentration at follow-up was 111 [56-257] µM and two patients had sCr above 200 µM. CONCLUSIONS: In this study, renal function recovered in patients discharged from hospital following renal replacement therapy after CSA-AKI. No patients needed further renal replacement therapy and only two (4%) had a sCr > 200 µM at follow-up.

Durability of Transcatheter and Surgical Bioprosthetic Aortic Valves in Patients at Lower Surgical Risk.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is an alternative to surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis and intermediate or high surgical risk. OBJECTIVES: The aim of this study was to compare the durability of transcatheter and surgical bioprosthetic aortic valves using standardized criteria. METHODS: In the NOTION (Nordic Aortic Valve Intervention) trial, all-comer patients with severe aortic stenosis and lower surgical risk for mortality were randomized 1:1 to TAVR (n = 139) or SAVR (n = 135). Moderate/severe structural valve deterioration (SVD) was defined as a mean gradient ≥20 mm Hg, an increase in mean gradient ≥10 mm Hg from 3 months post-procedure, or more than mild intraprosthetic aortic regurgitation (AR) either new or worsening from 3 months post-procedure. Nonstructural valve deterioration (NSVD) was defined as moderate/severe patient-prosthesis mismatch at 3 months or moderate/severe paravalvular leakage. Bioprosthetic valve failure (BVF) was defined as: valve-related death, aortic valve reintervention, or severe hemodynamic SVD. RESULTS: At 6 years, the rates of all-cause mortality were similar for TAVR (42.5%) and SAVR (37.7%) patients (p = 0.58). The rate of SVD was higher for SAVR than TAVR (24.0% vs. 4.8%; p < 0.001), whereas there were no differences in NSVD (57.8% vs. 54.0%; p = 0.52) or endocarditis (5.9% vs. 5.8%; p = 0.95). BVF rates were similar after SAVR and TAVR through 6 years (6.7% vs. 7.5%; p = 0.89). CONCLUSIONS: In the NOTION trial through 6 years, SVD was significantly greater for SAVR than TAVR, whereas BVF was low and similar for both groups. Longer-term follow-up of randomized clinical trials will be necessary to confirm these findings. (Nordic Aortic Valve Intervention Trial; NCT01057173).

Antithrombotic therapy after bioprosthetic aortic valve implantation: Warfarin versus aspirin, a randomized controlled trial.

BACKGROUND: The optimal medical strategy for prevention of thromboembolic events after surgical bioprosthetic aortic valve replacement (BAVR) is still debated. The objective of this study was to compare warfarin therapy (target INR of 2.0 to 3.0) with aspirin 150mg daily as antithrombotic therapy for the first three months after BAVR with or without concomitant coronary artery bypass grafting (CABG). The aim was to evaluate thromboembolic complications, major bleeding complications and death. MATERIALS AND METHODS: Prospective, single-centre, open-label, randomized controlled trial. 370 patients were enrolled, 328 were available for data analysis. RESULTS: At baseline the warfarin and aspirin groups were comparable. Thromboembolic events were comparable between groups 11 (6.6%) vs. 12 (7.5%), p=0.83. Major bleeding events occurred numerically more often in warfarin patients 9 (5.4%) vs. 3 (1.9%), p=0.14. Warfarin was in multivariate analysis significantly associated with major bleeding OR 5.18 (CI 1.06-25.43), p=0.043. 90-day mortality was comparable between groups 8 (4.7%) vs. 6 (3.7%), p=0.79. CONCLUSIONS: Our results suggest that aspirin might be equally effective as warfarin in preventing thromboembolic events after BAVR, but with less major bleedings. Although this is numerically the largest trial testing this hypothesis in a prospective randomized trial, further adequately powered studies are warranted.

No clinical effect of prosthesis-patient mismatch after transcatheter versus surgical aortic valve replacement in intermediate- and low-risk patients with severe aortic valve stenosis at mid-term follow-up: an analysis from the NOTION trial.

OBJECTIVES: Prosthesis-patient mismatch (PPM) after surgical aortic valve replacement (SAVR) for severe aortic valve stenosis (AVS) is common, but less common after transcatheter aortic valve replacement (TAVR) in patients considered at high risk for death after surgery. The objectives of this study were to determine incidence and clinical effect of PPM after SAVR and TAVR in a primarily low-risk patient group. METHODS: Patients 70 years or older with severe isolated AVS, regardless of predicted operative mortality risk, were consecutively randomized 1:1 to TAVR using a self-expandable bioprosthesis (n = 145) or SAVR (n = 135). Post-procedure PPM was graded after 3 months as follows: Not present-mild, if indexed effective orifice area (iEOA) >0.85 cm2/m2, moderate, if 0.65 cm2/m2 < iEOA ≤ 0.85 cm2/m2 and severe, if iEOA ≤0.65 cm2/m2. Outcomes were major adverse cardiac and cerebrovascular events (MACCE, e.g. composite rate of all-cause death, stroke, myocardial infarction or valve reintervention), cardiac-related hospitalizations and New York Heart Association (NYHA) functional class after 2 years. RESULTS: The incidence and the severity of PPM were significantly lower after TAVR compared with SAVR (severe, moderate, none-mild 14.0, 35.5, 50.4 vs 33.9, 36.7, 29.4%; P<0.001). PPM resulted in similar higher mean valve gradients at 3 months for both groups. Baseline characteristics related to severe PPM were younger age, absence of diabetes mellitus, lower mortality-risk score for TAVR, and younger age and higher body mass index for SAVR. At 2 years, there were numerical but no statistically significant differences between both TAVR and SAVR patients with severe and no severe PPM for MACCE (0.0 vs 12.8% for TAVR; P = 0.13, and 13.5 vs 7.0% for SAVR; P = 0.27), number of cardiac-related hospitalizations (mean ± standard deviation 0.4 ± 0.6 vs 0.6 ± 0.8; P = 0.23, and 0.4 ± 0.8 vs 0.5 ± 0.9; P = 0.70) and NYHA functional class (Class I/II/III/IV: 64.7/29.4/5.9/0.0 vs 62.1/34.7/3.2/0.0%, respectively; P = 0.91, and 71.4/25.7/2.9/0.0 vs 72.9/22.9/4.3/0.0%, respectively; P = 0.92). CONCLUSIONS: The incidence of PPM was lower and less severe after TAVR compared with SAVR in intermediate- and low-risk patients with severe AVS. There were no significant differences in MACCE, cardiac-related hospitalizations or NYHA class after 2 years for patients with versus those without severe PPM.

Two-Year Outcomes in Patients With Severe Aortic Valve Stenosis Randomized to Transcatheter Versus Surgical Aortic Valve Replacement: The All-Comers Nordic Aortic Valve Intervention Randomized Clinical Trial.

BACKGROUND: The Nordic Aortic Valve Intervention (NOTION) trial was the first to randomize all-comers with severe native aortic valve stenosis to either transcatheter aortic valve replacement (TAVR) with the CoreValve self-expanding bioprosthesis or surgical aortic valve replacement (SAVR), including a lower-risk patient population than previous trials. This article reports 2-year clinical and echocardiographic outcomes from the NOTION trial. METHODS AND RESULTS: Two-hundred eighty patients from 3 centers in Denmark and Sweden were randomized to either TAVR (n=145) or SAVR (n=135) with follow-up planned for 5 years. There was no difference in all-cause mortality at 2 years between TAVR and SAVR (8.0% versus 9.8%, respectively; P=0.54) or cardiovascular mortality (6.5% versus 9.1%; P=0.40). The composite outcome of all-cause mortality, stroke, or myocardial infarction was also similar (15.8% versus 18.8%, P=0.43). Forward-flow hemodynamics were improved following both procedures, with effective orifice area significantly more improved after TAVR than SAVR (effective orifice area, 1.7 versus 1.4 cm(2) at 3 months). Mean valve gradients were similar after TAVR and SAVR. When patients were categorized according to Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) (<4% versus ≥4%), there was no statistically significant difference for TAVR and SAVR groups in the composite outcome for low-risk (14.7%, 95% confidence interval, 8.3-21.2 versus 16.8%; 95% confidence interval, 9.7-23.8; P=0.58) or intermediate-risk patients (21.1% versus 27.1%; P=0.59). CONCLUSIONS: Two-year results from the NOTION trial demonstrate the continuing safety and effectiveness of TAVR in lower-risk patients. Longer-term data are needed to verify the durability of this procedure in this patient population. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01057173.

Transcatheter Versus Surgical Aortic Valve Replacement in Patients With Severe Aortic Valve Stenosis: 1-Year Results From the All-Comers NOTION Randomized Clinical Trial.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is an option in certain high-risk surgical patients with severe aortic valve stenosis. It is unknown whether TAVR can be safely introduced to lower-risk patients. OBJECTIVES: The NOTION (Nordic Aortic Valve Intervention Trial) randomized clinical trial compared TAVR with surgical aortic valve replacement (SAVR) in an all-comers patient cohort. METHODS: Patients ≥ 70 years old with severe aortic valve stenosis and no significant coronary artery disease were randomized 1:1 to TAVR using a self-expanding bioprosthesis versus SAVR. The primary outcome was the composite rate of death from any cause, stroke, or myocardial infarction (MI) at 1 year. RESULTS: A total of 280 patients were randomized at 3 Nordic centers. Mean age was 79.1 years, and 81.8% were considered low-risk patients. In the intention-to-treat population, no significant difference in the primary endpoint was found (13.1% vs. 16.3%; p = 0.43 for superiority). The result did not change in the as-treated population. No difference in the rate of cardiovascular death or prosthesis reintervention was found. Compared with SAVR-treated patients, TAVR-treated patients had more conduction abnormalities requiring pacemaker implantation, larger improvement in effective orifice area, more total aortic valve regurgitation, and higher New York Heart Association functional class at 1 year. SAVR-treated patients had more major or life-threatening bleeding, cardiogenic shock, acute kidney injury (stage II or III), and new-onset or worsening atrial fibrillation at 30 days than did TAVR-treated patients. CONCLUSIONS: In the NOTION trial, no significant difference between TAVR and SAVR was found for the composite rate of death from any cause, stroke, or MI after 1 year. (Nordic Aortic Valve Intervention Trial [NOTION]; NCT01057173).

Multimodal analgesia versus traditional opiate based analgesia after cardiac surgery, a randomized controlled trial.

BACKGROUND: To evaluate if an opiate sparing multimodal regimen of dexamethasone, gabapentin, ibuprofen and paracetamol had better analgesic effect, less side effects and was safe compared to a traditional morphine and paracetamol regimen after cardiac surgery. METHODS: Open-label, prospective randomized controlled trial. 180 patients undergoing cardiac procedures through median sternotomy, were included in the period march 2007-August 2009. 151 patients were available for analysis. Pain was assessed with the 11-numeric rating scale (11-NRS). RESULTS: Patients in the multimodal group demonstrated significantly lower average pain scores from the day of surgery throughout the third postoperative day. Extensive nausea and vomiting, was found in no patient in the multimodal group but in 13 patients in the morphine group, p < 0.001. Postoperative rise in individual creatinine levels demonstrated a non-significant rise in the multimodal group, 33.0±53.4 vs. 19.9±48.5, p = 0.133. Patients in the multimodal group suffered less major in-hospital events in crude numbers: myocardial infarction (MI) (1 vs. 2, p = 0.54), stroke (0 vs. 3, p = 0.075), dialysis (1 vs. 2, p = 0.54), and gastrointestinal (GI) bleeding (0 vs. 1, p = 0.31). 30-day mortality was 1 vs. 2, p = 0.54. CONCLUSIONS: In patients undergoing cardiac surgery, a multimodal regimen offered significantly better analgesia than a traditional opiate regimen. Nausea and vomiting complaints were significantly reduced. No safety issues were observed with the multimodal regimen. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT01966172.

The Nordic aortic valve intervention (NOTION) trial comparing transcatheter versus surgical valve implantation: study protocol for a randomised controlled trial.

BACKGROUND: Degenerative aortic valve (AV) stenosis is the most prevalent heart valve disease in the western world. Surgical aortic valve replacement (SAVR) has until recently been the standard of treatment for patients with severe AV stenosis. Whether transcatheter aortic valve implantation (TAVI) can be offered with improved safety and similar effectiveness in a population including low-risk patients has yet to be examined in a randomised setting. METHODS/DESIGN: This randomised clinical trial will evaluate the benefits and risks of TAVI using the transarterial CoreValve System (Medtronic Inc., Minneapolis, MN, USA) (intervention group) compared with SAVR (control group) in patients with severe degenerative AV stenosis. Randomisation ratio is 1:1, enrolling a total of 280 patients aged 70 years or older without significant coronary artery disease and with a low, moderate, or high surgical risk profile. Trial outcomes include a primary composite outcome of myocardial infarction, stroke, or all-cause mortality within the first year after intervention (expected rates 5% for TAVI, 15% for SAVR). Exploratory safety outcomes include procedure complications, valve re-intervention, and cardiovascular death, as well as cardiac, cerebral, pulmonary, renal, and vascular complications. Exploratory efficacy outcomes include New York Heart Association functional status, quality of life, and valve prosthesis and cardiac performance. Enrolment began in December 2009, and 269 patients have been enrolled up to December 2012. DISCUSSION: The trial is designed to evaluate the performance of TAVI in comparison with SAVR. The trial results may influence the choice of treatment modality for patients with severe degenerative AV stenosis. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01057173.

Hypercoagulability in patients undergoing coronary artery bypass grafting: prevalence, patient characteristics and postoperative outcome.

OBJECTIVES: To investigate the prevalence of preoperative hypercoagulability assessed by thromboelastography (TEG), to identify patient characteristics associated with hypercoagulability and to explore whether hypercoagulability is associated with a greater risk for myocardial infarction (MI), stroke and mortality 30 days after coronary artery bypass grafting (CABG) surgery. METHODS: This is a prospective, observational study of 200 consecutive CABG surgery patients. Hypercoagulability was defined as TEG maximum amplitude >69 mm. RESULTS: Eighty-seven out of 200 (43.5%) CABG patients were TEG-hypercoagulable. In univariate regression analysis, age, female gender, hypertension, severe chronic obstructive pulmonary disease, platelet count and fibrinogen level were significantly associated with TEG-hypercoagulability. Multivariate regression analysis revealed higher age, platelet count and fibrinogen levels as variables independently associated with TEG-hypercoagulability. Thirty-day outcome data: MI (TEG-hypercoagulable 6.9% vs. TEG-normocoagulable 3.7%, NS), stroke (8.0 vs. 2.8%, NS) and mortality (4.6 vs. 0.9%, NS). There was a significant difference in 30-day combined event rate of MI, stroke and mortality (17.2 vs. 6.6%, P = 0.019). In univariate analysis, only female gender and TEG-hypercoagulability were significantly associated with 30-day combined event rate. In multivariate analysis, only female gender was significantly associated with 30-day outcome (P = 0.014), whereas TEG-hypercoagulability demonstrated a trend (P = 0.065). CONCLUSIONS: Hypercoagulability identified by TEG was preoperatively found in 43.5% of CABG patients, and the findings of this study support the notion that TEG-hypercoagulable patients have a higher risk for a combination of thromboembolic complications and death after surgery.

Thrombelastographic haemostatic status and antiplatelet therapy after coronary artery bypass surgery (TEG-CABG trial): assessing and monitoring the antithrombotic effect of clopidogrel and aspirin versus aspirin alone in hypercoagulable patients: study protocol for a randomized controlled trial.

BACKGROUND: Hypercoagulability, assessed by the thrombelastography (TEG) assay, has in several observational studies been associated with an increased risk of post-procedural thromboembolic complications. We hypothesize that intensified antiplatelet therapy with clopidogrel and aspirin, as compared to aspirin alone, will improve saphenous vein graft patency in preoperatively TEG-Hypercoagulable coronary artery bypass surgery (CABG) patients and reduce their risk for thromboembolic complications and death postoperatively. METHODS/DESIGN: This is a prospective randomized clinical trial, with an open-label design with blinded evaluation of graft patency. TEG-Hypercoagulability is defined as a TEG maximum amplitude above 69 mm. Two hundred and fifty TEG-Hypercoagulable patients will be randomized to either an interventional group receiving clopidogrel 75 mg daily for three months (after initial oral bolus of 300 mg) together with aspirin 75 mg or a control group receiving aspirin 75 mg daily alone. Monitoring of antiplatelet efficacy and on-treatment platelet reactivity to clopidogrel and aspirin will be conducted with Multiplate aggregometry. Graft patency will be assessed with Multislice computed tomography (MSCT) at three months after surgery. CONCLUSIONS: The present trial is the first randomized clinical trial to evaluate whether TEG-Hypercoagulable CABG patients will benefit from intensified antiplatelet therapy after surgery. Monitoring of platelet inhibition from instituted antithrombotic therapy will elucidate platelet resistance patterns after CABG surgery. The results could be helpful in redefining how clinicians can evaluate patients preoperatively for their postoperative thromboembolic risk and tailor individualized postoperative antiplatelet therapy. TRIAL REGISTRATION: Clinicaltrials.gov Identifier NCT01046942.

Current status of pulmonary metastasectomy.

Malignant disease's ability to metastasize remains one of the major obstacles when treating patients with cancer. The change from loco-regional to systemic disease usually renders the patient beyond surgical treatment, as local treatment with surgery in a systemic disease is usually considered without benefit. However, numerous retrospective studies have demonstrated that resection of metastases limited to the lungs may be associated with prolonged survival. No prospective, randomized studies have been published, and most series compare highly selected patients with historical data for unresected patients. In this article, we discuss the current status on pulmonary metastasectomy. Preoperative assessment and selection of surgical candidates is covered. The different surgical strategies including surgical approach, unilateral versus bilateral exploration, lymph node dissection, and repeat surgery are discussed. Finally, we review some of the common tumors that metastasize to the lungs, the role of metastasectomy in their treatment and the prognostic factors with impact on survival.

Outcome after pulmonary metastasectomy: analysis of 5 years consecutive surgical resections 2002-2006.

INTRODUCTION: In this study, we analyze the results of management of pulmonary metastases in 5 years consecutive operations at our institution. We aim to define the patients who are most likely to benefit from surgery by investigating long-term survival and prognostic factors associated with prolonged survival. METHODS: The data on all consecutive patients between 2002 and 2006 were reviewed retrospectively. One hundred seventy-eight patients underwent 256 surgical resections for suspected pulmonary metastases from different primary malignancies. Prognostic factors analyzed included age, sex, surgical approach, surgical resection, number of metastases, distribution of metastases, disease-free interval, presence of synchronous metastases, recurrence of disease, prior liver resection (colorectal cancer), and tumor histology (sarcomas). RESULTS: Complete resection was achieved in 248 cases (96.8%). The mean follow-up was 61.6 months. Five-year survival with respect to primary malignancy was colorectal carcinoma (50.3%), sarcoma (21.7%), malignant melanoma (25.0%), renal cell carcinoma (51.4%), and miscellaneous malignancies (50.0%). Of the prognostic factors analyzed by univariate analysis, none was found to be significant in all the different groups of cancers. CONCLUSIONS: Pulmonary metastasectomy is a safe and effective treatment that may be associated with prolonged survival in highly selected patients. Low morbidity and mortality rates in contrast with the lack of any other effective treatment justify the aggressive approach of surgery. Thoracoscopic resection is a valid option in selected patients. In case of recurrence of pulmonary disease and if the patient fulfils the initial criteria for pulmonary metastasectomy, repeat surgery should be performed. Solid prognostic factors still need to be established.

Transcatheter aortic valve prosthesis surgically replaced 4 months after implantation.

Transcatheter aortic valve implantation is a new and rapidly evolving treatment option for high-risk surgical patients with degenerative aortic valve stenosis. Long-term results with these new valve prostheses are lacking, and potential valve dysfunction and failure would require valve replacement. We report the first case of surgical valve replacement in a patient with a dysfunctional transcatheter-implanted aortic valve prosthesis 4 months after implantation.