Objective The aim of this propensity-matched, multicenter study was to compare early clinical and echocardiographic outcomes of patients undergoing transapical aortic valve implantation (TA-TAVI) ...versus patients undergoing sutureless aortic valve replacement (SU-AVR) for severe symptomatic aortic valve stenosis. Methods We reviewed 468 TA-TAVIs performed in 20 centers from April 2008 to May 2011, and 51 SU-AVRs performed in 3 centers from March to September 2011. Based on a propensity score analysis, 2 groups with 38 matched pairs were created. Variables used in the propensity analysis were age, sex, body surface area, New York Heart Association class, logistic EuroSCORE, peripheral vascular disease, chronic obstructive pulmonary disease, aortic valve area, mitral regurgitation, and left ventricular ejection fraction. Results Preoperative characteristics of the 2 groups were comparable. Hospital mortality was 5.3% and 0% in the TA-TAVI and SU-AVR groups, respectively ( P = .49). We did not observe stroke or acute myocardial infarction in the 2 groups. Permanent pacemaker implantation was needed in 2 patients of each group (5.3%, P = 1.0). Dialysis was required in 2 patients (5.3%) in the SU-AVR group and in 1 patient (2.7%) in the TA-TAVI group ( P = 1.0). Predischarge echocardiographic data showed that the incidence of paravalvular leak (at least mild) was greater in the TA-TAVI group (44.7% vs 15.8%, P = .001), but there were no differences in terms of mean transprosthetic gradient (10.3 ± 5 mm Hg vs 11 ± 3.7 mm Hg, P = .59). Conclusions This preliminary experience showed that, in patients at high risk for conventional surgery, SU-AVR is as safe and effective as TA-TAVI and that it is associated with a lower rate of postprocedural paravalvular leak.
Objective Although surgical aortic valve replacement (SAVR) is the treatment of choice for patients with aortic valve stenosis, transcatheter aortic valve replacement (TAVR) and sutureless aortic ...valve replacement (SU-AVR) have shown good results. The aim of our multicenter, propensity-matched study was to compare the clinical and hemodynamic outcomes of surgical SAVR, transapical TAVR (TA-TAVR), and SU-AVR. Methods We analyzed data from 566 TA-TAVR, 349 SAVR, and 38 SU-AVR patients treated from January 2009 to March 2012. We used a propensity-matching strategy to compare on-pump (SAVR, SU-AVR) and off-pump (TA-TAVR) surgical techniques. The outcomes were analyzed using multivariate weighted logistic regression or multinomial logistic analysis. Results In the matched cohorts, the 30-day overall mortality was significantly lower after SAVR than TA-TAVR (7% vs 1.8%, P = .026), with no differences in mortality between SU-AVR and TA-TAVR. Multivariate analysis showed SU-AVR to have a protective effect, although not statistically significant, against aortic regurgitation, pacemaker implantation, and renal replacement therapy compared with TA-TAVR. Compared with TA-TAVR, SAVR demonstrated significant protection against aortic regurgitation (odds ratio, 0.04; P < .001) and a trend toward protection against death, pacemaker implantation, and myocardial infarction. The mean transaortic gradient was 10.3 ± 4.4 mm Hg, 11 ± 3.4 mm Hg, and 16.5 ± 5.8 mm Hg in the TA-TAVR, SU-AVR, and SAVR patients, respectively. Conclusions SAVR was associated with lower 30-day mortality than TA-TAVR. SAVR was also associated with a lower risk of postoperative aortic regurgitation compared with TA-TAVR. We did not find other significant differences in outcomes among matched patients treated with SAVR, SU-AVR, and TA-TAVR.
Background Acute fulminant myocarditis (AFM) may represent a life-threatening event, characterized by rapidly progressive cardiac compromise that ultimately leads to refractory cardiogenic shock or ...cardiac arrest. Venoarterial extracorporeal membrane oxygenation (VA-ECMO) provides effective cardiocirculatory support in this circumstance, but few clinical series are available about early and long-term results. Data from a multicenter study group are reported which analyzed subjects affected by AFM and treated with VA-ECMO during a 5-year period. Method From hospital databases, 57 patients with diagnoses of AFM treated with VA-ECMO in the past 5 years were found and analyzed. Mean age was 37.6 ± 11.8 years; 37 patients were women. At VA-ECMO implantation, cardiogenic shock was present in 38 patients, cardiac arrest in 12, and severe hemodynamic instability in 7. A peripheral approach was used with 47 patients, whereas 10 patients had a central implantation or other access. Results Mean VA-ECMO support was 9.9 ± 19 days (range, 2 to 24 days). Cardiac recovery with ECMO weaning was achieved in 43 patients (75.5%), major complications were observed in 40 patients (70.1%), and survival to hospital discharge occurred in 41 patients (71.9%). After hospital discharge (median follow-up, 15 months) there were 2 late deaths. The 5-year actual survival was 65.2% ± 7.9%, with recurrent self-recovering myocarditis observed in 2 patients (at 6 and 12 months from the first AFM event), and 1 heart transplantation. Conclusions Cardiopulmonary support with VA-ECMO provides an invaluable tool in the treatment of AFM, although major complications may characterize the hospital course. Long-term outcome appears favorable with rare episodes of recurrent myocarditis or cardiac-related events.
Summary Background Risk of relapse or progression remains high in the treatment of most patients with epithelial ovarian cancer, and development of a molecular predictor could be a valuable tool for ...stratification of patients by risk. We aimed to develop a microRNA (miRNA)-based molecular classifier that can predict risk of progression or relapse in patients with epithelial ovarian cancer. Methods We analysed miRNA expression profiles in three cohorts of samples collected at diagnosis. We used 179 samples from a Multicenter Italian Trial in Ovarian cancer trial (cohort OC179) to develop the model and 263 samples from two cancer centres (cohort OC263) and 452 samples from The Cancer Genome Atlas epithelial ovarian cancer series (cohort OC452) to validate the model. The primary clinical endpoint was progression-free survival, and we adapted a semi-supervised prediction method to the miRNA expression profile of OC179 to identify miRNAs that predict risk of progression. We assessed the independent prognostic role of the model using multivariable analysis with a Cox regression model. Findings We identified 35 miRNAs that predicted risk of progression or relapse and used them to create a prognostic model, the 35-miRNA-based predictor of Risk of Ovarian Cancer Relapse or progression (MiROvaR). MiROvaR was able to classify patients in OC179 into a high-risk group (89 patients; median progression-free survival 18 months 95% CI 15–22) and a low-risk group (90 patients; median progression-free survival 38 months 24–not estimable; hazard ratio HR 1·85 1·29–2·64, p=0·00082). MiROvaR was a significant predictor of progression in the two validation sets (OC263 HR 3·16, 95% CI 2·33–4·29, p<0·0001; OC452 HR 1·39, 95% CI 1·11–1·74, p=0·0047) and maintained its independent prognostic effect when adjusted for relevant clinical covariates using multivariable analyses (OC179: adjusted HR 1·48, 95% CI 1·03–2·13, p=0·036; OC263: adjusted HR 3·09 2·24–4·28, p<0·0001; and OC452: HR 1·41 1·11–1·79, p=0·0047). Interpretation MiROvaR is a potential predictor of epithelial ovarian cancer progression and has prognostic value independent of relevant clinical covariates. MiROvaR warrants further investigation for the development of a clinical-grade prognostic assay. Funding AIRC and CARIPLO Foundation.
Background Venoarterial extracorporeal membrane oxygenation (VA-ECMO) for refractory cardiogenic shock (RCS) is increasingly used in adult patients, but age represents a controversial factor in this ...setting. Methods Data from the Extracorporeal Life Support Organization registry was analyzed to assess in-hospital survival of elderly patients (≥70 years of age) undergoing VA-ECMO for RCS from 1992 to 2015. In-hospital survival and complications for elderly patients were compared with data in younger adults (≥18 to <70 years of age) supported with VA-ECMO during the same time period for similar indications. Results The mean age of the patient cohort (n = 5,408) was 53.0 ± 15.7 years (range, 18 to 91 years). The elderly group included 735 patients (13.6%), with a mean age of 75.2 ± 4.4 years. In the elderly group, pre-ECMO cardiac procedures were performed in 134 cases (18.9%), and 2.2% received VA-ECMO for postcardiotomy support compared with 0.7% in the younger cohort. The mean duration of VA-ECMO in the elderly group was 101 ± 91 h compared with 138 ± 146 h in the younger group ( p < 0.001). Overall, survival to hospital discharge for the entire adult cohort was 41.4% (2,240 of 5,408), with 30.5% (224 of 735) in the elderly patient group and 43.1% (2,016 of 4,673) in the younger patient group ( p < 0.001). Elderly patients had a higher rate of multiorgan failure. At multivariable analysis age represented an independent negative predictor of in-hospital survival. Conclusions Based on the acceptable survival to hospital discharge in our study, older age alone should not represent an absolute contraindication when considering VA-ECMO support for RCS.
Summary Background Carboplatin plus paclitaxel administered every 3 weeks is standard first-line chemotherapy for patients with advanced ovarian cancer. A weekly paclitaxel schedule combined with ...carboplatin every 3 weeks prolonged progression-free survival and overall survival in a Japanese phase 3 trial. The aim of our study was to assess whether a weekly schedule of carboplatin plus paclitaxel is more effective than the same drugs given every 3 weeks. Methods We did a multicentre, randomised, phase 3 study at 67 institutions in Italy and France. Women with FIGO stage IC–IV ovarian cancer, an ECOG performance status of 2 or lower, and who had never received chemotherapy were randomly allocated in a 1:1 ratio to receive either carboplatin (AUC 6 mg/mL per min) plus paclitaxel (175 mg/m2 ) every 3 weeks for six cycles or carboplatin (AUC 2 mg/mL per min) plus paclitaxel (60 mg/m2 ) every week for 18 weeks. Randomisation was done by computer-based minimisation, stratified by centre, residual disease after surgery, and ECOG performance status. The study was not blinded. Coprimary endpoints were progression-free survival and quality of life (assessed by the Functional Assessment of Cancer Therapy Ovarian Trial Outcome Index FACT-O/TOI score), and analysis was by modified intention to treat. This report presents the final analysis. The study is registered with ClinicalTrials.gov , number NCT00660842. Findings 822 patients were enrolled into the study between Nov 20, 2008, and March 1, 2012; 12 withdrew their consent immediately after randomisation and were excluded, and 810 were eligible for analysis. 404 women were allocated treatment every 3 weeks and 406 were assigned to the weekly schedule. After median follow-up of 22·3 months (IQR 16·2–30·9), 449 progression-free survival events were recorded. Median progression-free survival was 17·3 months (95% CI 15·2–20·2) in patients assigned to treatment every 3 weeks, versus 18·3 months (16·8–20·9) in women allocated to the weekly schedule (hazard ratio 0·96, 95% CI 0·80–1·16; p=0·66). FACT-O/TOI scores differed significantly between the two schedules (treatment-by-time interaction p<0·0001); with treatment every 3 weeks, FACT-O/TOI scores worsened at every cycle (weeks 1, 4, and 7), whereas for the weekly schedule, after transient worsening at week 1, FACT-O/TOI scores remained stable. Fewer patients assigned to the weekly group than those allocated treatment every 3 weeks had grade 3–4 neutropenia (167 42% of 399 patients vs 200 50% of 400 patients), febrile neutropenia (two 0·5% vs 11 3%), grade 3–4 thrombocytopenia (four 1% vs 27 7%), and grade 2 or worse neuropathy (24 6% vs 68 17%). Three deaths during the study were attributed to chemotherapy; two women died who were allocated treatment every 3 weeks and one death was recorded in the group assigned the weekly regimen. Interpretation A weekly regimen of carboplatin and paclitaxel might be a reasonable option for first-line treatment of women with advanced ovarian cancer. Funding None.
Acute kidney injury (AKI) occurs in as many as 40% of patients after cardiac surgery and requires dialysis in 1% of cases. Acute kidney injury is associated with an increased risk of mortality and ...morbidity, predisposes patients to a longer hospitalization, requires additional treatments, and increases the hospital costs. Acute kidney injury is characterized by a progressive worsening course, being the consequence of an interplay of different pathophysiologic mechanisms, with patient-related factors and cardiopulmonary bypass as major causes. Recently, several novel biomarkers have emerged, showing reasonable sensitivity and specificity for AKI prediction and protection. The development and implementation of potentially protective therapies for AKI remains essential, especially for the relevant impact of AKI on early and late survival.
Summary Background Clinical trials are needed to assess the clinical benefit of antithrombotic prophylaxis in patients with cancer who are receiving chemotherapy, since these patients are at an ...increased risk of developing a thromboembolism. We did a trial to assess the clinical benefit of the low-molecular-weight heparin nadroparin for the prophylaxis of thromboembolic events in ambulatory patients receiving chemotherapy for metastatic or locally advanced solid cancer. Methods Between October, 2003, and May, 2007, ambulatory patients with lung, gastrointestinal, pancreatic, breast, ovarian, or head and neck cancer were randomly assigned in a double-blind manner to receive subcutaneous injections of nadroparin (3800 IU anti-Xa once a day, n=779) or placebo (n=387), in a 2:1 ratio. Study treatment was given for the duration of chemotherapy up to a maximum of 4 months. The primary study outcome was the composite of symptomatic venous or arterial thromboembolic events, as assessed by an independent adjudication committee. All randomised patients who received at least one dose of study treatment were included in the efficacy and safety analyses (modified intention-to-treat population). The study is registered with ClinicalTrials.gov , NCT 00951574. Findings 1150 patients were included in the primary efficacy and safety analyses: 769 patients in the nadroparin group and 381 patients in the placebo group. 15 (2·0%) of 769 patients treated with nadroparin and 15 (3·9%) of 381 patients treated with placebo had a thromboembolic event (single-sided p=0·02). Five (0·7%) of 769 patients in the nadroparin group and no patients in the placebo group had a major bleeding event (two-sided p=0·18). The incidences of minor bleeding were 7·4% (57 of 769) with nadroparin and 7·9% (30 of 381) with placebo. There were 121 (15·7%) serious adverse events in the nadroparin goup and 67 (17·6%) serious adverse events in the placebo group. Interpretation Nadroparin reduces the incidence of thromboembolic events in ambulatory patients with metastatic or locally advanced cancer who are receiving chemotherapy. Future studies should focus on patients who are at a high risk for thromboembolic events. Funding Italfarmaco SpA, Milan, Italy.
Objective The very long-term results of the double-orifice mitral valve repair are unknown. The aim of this study was to assess the late clinical and echocardiographic outcomes of this technique in ...patients with degenerative mitral regurgitation. Methods From 1993 to 2000, 174 patients with severe degenerative mitral regurgitation were treated with the double-orifice technique combined with ring annuloplasty. Mean age of patients was 52 ± 12.8 years, New York Heart Association class I or II was present in 71% of the patients, atrial fibrillation in 17.2%, and preoperative left ventricular ejection fraction was 59.5% ± 7.5%. Mitral regurgitation was due to anterior leaflet prolapse in 36 patients (20.6%), bileaflet prolapse in 128 (73.5%), and posterior leaflet prolapse in 10 patients (5.7%). Results There were no hospital deaths. At hospital discharge, mitral regurgitation was absent or mild in 169 patients (97.1%) and moderate (2+/4+) in 5 patients (2.8%). Mitral stenosis requiring reoperation was detected in 1 patient (0.6%). Clinical and echocardiographic follow-up was 97.1% complete (mean length, 11.5 ± 2.53 years; median, 11.6 years; longest duration, 17.6 years). At 14 years, actuarial survival was 86.9% ± 3.37%, freedom from cardiac death was 95.8% ± 1.54%, and freedom from reoperation was 89.6 ± 2.51%. At the last echocardiographic examination, recurrence of mitral regurgitation ≥3+ was documented in 23 patients (23/169, 13.6%). Freedom from mitral regurgitation ≥3+ at 14 years was 83.8% ± 3.39%. The only predictor of recurrence of mitral regurgitation ≥3+ was residual mitral regurgitation greater than mild at hospital discharge (hazard ratio, 5.7; 95% confidence interval, 1.6-20.6; P = .007). Conclusions The double-orifice repair combined with ring annuloplasty provides very satisfactory long-term results in patients with degenerative mitral regurgitation in the setting of bileaflet and anterior leaflet prolapse.
Abstract We present a simple solution to address—at the same time—the issue of spinal perfusion, overload on the left ventricle, and brain perfusion during complex distal arch and descending aortic ...surgery. It is a modification of a passive Gott shunt that includes an extra 10-mm tube interposed between the side port of the ascending aorta cannula and the left subclavian artery. This technique may represent an extra option for surgeons during complex aortic surgery to maintain satisfactory distal perfusion, to reduce the cardiac load, and to provide adequate perfusion to the brain.
PDF
