Treatment of severe symptomatic aortic valve stenosis using non-invasive ultrasound therapy: a cohort study.

BACKGROUND: Calcific aortic stenosis is commonly treated using surgical or transcatheter aortic valve replacement; however, many patients are not considered suitable candidates for these interventions due to severe comorbidities and limited life expectancy. As such, non-invasive therapies might offer alternative therapeutic possibilities in these patients. This study aimed to assess the safety of non-invasive ultrasound therapy and its ability to improve valvular function by softening calcified valve tissue. METHODS: This prospective, multicentre, single-arm series enrolled 40 adult patients with severe symptomatic aortic valve stenosis at three hospitals in France, the Netherlands, and Serbia between March 13, 2019, and May 8, 2022. Patients were treated with transthoracically delivered non-invasive ultrasound therapy. Follow-ups were scheduled at 1, 3, 6, 12, and 24 months. The primary endpoints were procedure-related deaths within 30 days and improved valve function. We report the 6-month data. This study is registered at ClinicalTrials.gov, NCT03779620 and NCT04665596. FINDINGS: 40 high-risk patients with a mean Society of Thoracic Surgeons score of 5·6% (SD 4·4) and multiple severe comorbidities were included. The primary endpoint, procedure-related mortality, did not occur; furthermore, no life-threatening or cerebrovascular events were reported. Improved valve function was confirmed up to 6 months, reflected by a 10% increase in mean aortic valve area from 0·58 cm2 (SD 0·19) at baseline to 0·64 cm2 (0·21) at follow-up (p=0·0088), and a 7% decrease in mean pressure gradient from 41·9 mm Hg (20·1) to 38·8 mm Hg (17·8; p=0·024). At 6 months, the New York Heart Association score had improved or stabilised in 24 (96%) of 25 patients, and the mean Kansas City Cardiomyopathy Questionnaire score had improved by 33%, from 48·5 (SD 22·6) to 64·5 (21·0). One serious procedure-related adverse event occurred in a patient who presented with a transient decrease in peripheral oxygen saturation. Non-serious adverse events included pain, discomfort during treatment, and transient arrhythmias. INTERPRETATION: This novel, non-invasive ultrasound therapy for calcified aortic stenosis proved to be safe and feasible. FUNDING: Cardiawave.

Assessing the Novel Myval Balloon-Expandable Valve with the Evolut Valve: A Propensity-Matched Study.

BACKGROUND: The Myval balloon-expandable (BE) valve has shown encouraging early clinical data in terms of safety and efficacy. Comparative data with other well-established contemporary valves are nonetheless still scarce. This study aims to compare the performance of the Myval BE valve with the Evolut self-expanding (SE) valve. METHODS: In this retrospective single-center study, 223 patients with symptomatic severe aortic stenosis (AS) were included and treated with the Myval BE valve (n = 120) or with the Evolut SE valve (n = 103). Then, 91 pairs were compared after matching. Clinical outcomes were evaluated at 30 days and 1 year. Echocardiographic follow-up was performed at 30 days. RESULTS: Procedural complications were rare in both groups. At the 30-day follow-up, no significant difference in cardiac death (Myval: 1% vs. Evolut: 2%, p = 0.56), stroke (2% vs. 4%, p = 0.41) and myocardial infarction (1% vs. 3%, p = 0.31) was observed. A permanent pacemaker implantation (PPI) was significantly less needed in the Myval group (4% vs. 15%, p = 0.01). At 1 year, cardiac death (2% vs. 4%, p = 0.41) and the stroke rate (7% vs. 5%, p = 0.76) were similar. Moderate-severe paravalvular leakage (PVL) was also comparable in both groups (1% vs. 4%, p = 0.17). CONCLUSION: Safety and efficacy outcomes were comparable between the two valves, except for a higher PPI rate for the Evolut SE valve. Up to 1-year follow-up, clinical outcomes showed acceptable rates of stroke and cardiac death with both valves. Valve hemodynamics were excellent with a low rate of moderate-severe PVL in both groups.

Impact of thrombus burden on long-term clinical outcomes in patients with either anterior or non-anterior ST-segment elevation myocardial infarction.

Large thrombus burden (LTB) during ST-segment elevation myocardial infarction (STEMI) could translate into worse clinical outcomes. The impact of a LTB in terms of long-term clinical outcomes on different myocardial infarct territories has not yet been fully evaluated. From April 2002 to December 2004, consecutive patients with STEMI undergoing percutaneous coronary intervention with drug eluting stent were evaluated. The study sample was stratified in two groups: anterior STEMI and non-anterior STEMI. LTB was considered as a thrombus larger than or equal to 2-vessel diameters, and small thrombus burden less than 2-vessel diameters. Major adverse cardiac events (MACE) were evaluated at 10-year and survival data were collected up to 15-year. A total of 812 patients were evaluated, 6 patients were excluded due to inadequate angiographic images, 410 (50.9%) had an anterior STEMI and 396 (49.1%) a non-anterior STEMI. Patients with LTB had higher rates of 10-year mortality (aHR 2.27, 95%CI 1.42-3.63; p = 0.001) and 10-year MACE (aHR 1.46, 95%CI 1.03-2.08; p = 0.033) in anterior STEMI, but not in non-anterior STEMI (aHR 0.78, 95%CI 0.49-1.24; p = 0.298; aHR 0.71, 95%CI 0.50-1.02; p = 0.062). LTB was associated with increased 30-day mortality (aHR 5.60, 95%CI 2.49-12.61; p < 0.001) and 30-day MACE (aHR 2.72, 95%CI 1.45-5.08; p = 0.002) in anterior STEMI, but not in non-anterior STEMI (aHR 0.39, 95%CI 0.15-1.06; p = 0.066; aHR 0.67, 95%CI 0.31-1.46; p = 0.316). Beyond 30-day, LTB had no impact on mortality and MACE in both groups. In anterior STEMI, LTB is associated with worse long-term clinical outcomes, this effect was driven by early events.

Impact of Large Thrombus Burden on Very Long-Term Clinical Outcomes in Patients Presenting With ST-Segment Elevation Myocardial Infarction.

OBJECTIVES: The impact of large thrombus burden (LTB) on very long-term clinical outcomes in patients with ST-segment elevation myocardial infarction (STEMI) is unknown. We compared very long-term clinical outcomes in STEMI patients with either LTB or small thrombus burden (STB). METHODS: Between 2002 and 2004, thrombus burden (TB) was evaluated in consecutive patients with STEMI undergoing percutaneous coronary intervention (PCI). In occluded infarct-related arteries, TB was reclassified after flow restoration. LTB was defined as thrombus ≥2 vessel diameters. Major adverse cardiac event (MACE) rate was evaluated at 10-year follow-up and survival data were collected up to 15 years post PCI. RESULTS: A total of 812 patients were enrolled, and TB assessment was available for 806 patients (99.3%); 580 patients (72.0%) had STB and 226 patients (28.0%) had LTB. Patients with LTB experienced more no reflow (4.0% vs 0.5%; P<.01) and distal embolization (17.3% vs 3.4%; P<.001) than STB patients. Ten-year MACE rate (42.5% vs 42.4%; P=.59), 10-year mortality rate (27.0% vs 26.4%; P=.75), and 15-year mortality rate (31.9% vs 35.9%; P=.29) were similar between STB and LTB groups, respectively. By landmark analysis, MACE rate was higher in the LTB group (15.9% vs 8.8%; P<.01) at 30 days, but not beyond (31.6% vs 36.9%; P=.28). There was no difference in mortality at any time point (at 30 days, 9.7% vs 6.2%; P=.08; beyond 30 days, 17.3% vs 20.5%; P=.48). LTB was an independent predictor of MACE at 30 days post PCI (hazard ratio, 1.60; 95% confidence interval, 1.01-2.51; P=.04). CONCLUSIONS: In STEMI patients, LTB might identify a subpopulation at high risk of no-reflow, distal embolization, and early ischemic events, but is not associated with worse clinical outcomes at long-term follow-up.

A case report: adenosine triggered myocardial infarction during myocardial perfusion stress test imaging in a diabetic patient.

BACKGROUND: Myocardial perfusion imaging (MPI) using single-photon emission computed tomography (SPECT) can in general be used safely in daily clinical practice. However, under the right circumstances, it can lead to serious complications. CASE SUMMARY: A 68-year-old female patient with diabetes and a history of inferior ST-elevation myocardial infarction 8 years earlier, visited our outpatient clinic with atypical chest discomfort. In order to assess whether this is due to myocardial ischaemia, MPI-SPECT was ordered. As it was suspected she would not achieve sufficient exercise levels, pharmacologic stress using adenosine was arranged. During the scan, she developed acute myocardial infarction. Subsequent urgent coronary angiography demonstrated a subtotal stenosis in the proximal left anterior descending coronary artery which was successfully stented. She was still free from angina 4 months later. DISCUSSION: The combination of a reduced systemic and coronary perfusion pressure in the presence of an exhausted coronary autoregulation, may be a starting point for local geometrical changes that initiate the classic cascade of thrombus formation and acute occlusion of coronary arteries during MPI-SPECT. This illustrates the need for continuous patient and electrocardiogram monitoring.

Use of Lithotripsy in a Calcified Saphenous Vein Graft.

Percutaneous coronary interventions in saphenous vein grafts can pose a variety of challenges, such as severely calcified lesions. If these lesions are nondilatable, lithotripsy can arguably be a proper tool for lesion preparation. We present a case in which a nondilatable, calcified saphenous vein graft was successfully treated using Shockwave lithotripsy. (Level of Difficulty: Intermediate.).

Effectiveness of adherence to a preoperative antiplatelet and anticoagulation cessation protocol in cardiac surgery.

OBJECTIVES: Reduction of blood loss after cardiac surgery remains challenging. The effectiveness of adherence to a protocol on cessation of anticoagulants and platelet-inhibiting medications was investigated together with the influence of protocol violations on blood loss after surgery, use of blood products, surgical re-explorations and 30-day mortality. METHODS: Between 2009 and 2013, data were collected prospectively for all elective cardiac surgery procedures in adult patients (n = 1637). Two groups were distinguished: Group 1 adhered to the protocol for cessation or continuation of medication (n = 1287, 79%) and Group 2 violated the protocol (n = 350, 21%). RESULTS: Median blood loss was 300 ml (interquartile range 175-500 ml). Eighty patients underwent re-exploration due to blood loss (5%). Thirty-day mortality was 2% (n = 27). Protocol violation was associated with increased blood loss [median 275 ml (175-475 ml) vs 350 ml (250-612); P ≤ 0.001] and with increased average use of fresh frozen plasma (226 ml vs 139 ml; P << 0.00001), red blood cell transfusion (115 ml vs 87 ml; P = 0.081) and thrombocyte transfusions (52 ml vs 37 ml; P = 0.0082). The number of re-explorations (4% vs 6%; P = 0.39) and mortality risk (1% vs 2%; P = 0.72) did not differ. CONCLUSIONS: Balancing the benefit of continuing platelet inhibitors or anticoagulants versus cessation before surgery remains challenging. Adherence to the protocol will lead to lower blood loss and in a lower consumption of blood products although the decision to go for re-exploration and 30-day mortality does not differ compared with the protocol violation. Stopping medication does not lead to thromboembolic events.

Risk stratification for adult congenital heart surgery.

OBJECTIVE: At this moment, no risk stratification models are available for adult congenital cardiac surgery. This study aims to identify a suitable stratification tool for the adult congenital heart surgery population. Pediatric congenital cardiac surgery score models were therefore tested in an adult congenital population. In addition, an age component was added to these models and performance was compared with the original score systems. METHODS: The Risk Adjustment in Congenital Heart Surgery (RACHS-1), Basic Aristotle Score, Society of Thoracic Surgeons (STS)-European Association for Cardiothoracic Surgery (EACTS) Score and Comprehensive Aristotle Score were calculated for all adult patients who underwent congenital cardiac surgery between January 1990 and January 2007 in a single center (N=963). In addition, an age component was added to these models. Discrimination was then tested for all models with and without the age component. RESULTS: Application of the original pediatric risk scores resulted in c-statistics for 30-day mortality of 0.60, 0.60, 0.60, and 0.66 respectively. Combining these models with the age component resulted in significantly higher c-statistics of 0.69, 0.70, 0.69, and 0.76 respectively. Age as a sole predictor already resulted in a c-statistic of 0.67. Comparable results were found for 1-year mortality. CONCLUSIONS: The discriminatory power of the pediatric risk scores was suboptimal, but increased when adding age as a score component. The best performance was achieved by the combination of age and the Comprehensive Aristotle Score, for both 30-day and 1-year mortality.

Validation of a prognostic model to predict survival after non-small-cell lung cancer surgery.

OBJECTIVE: Surgery is the first choice of treatment for localised non-small-cell lung cancer (NSCLC). When making decisions regarding resection, physicians must balance the potential long-term benefits of surgery with the risk of surgery-related death, particularly among elderly patients with multiple co-morbid conditions. In 2005, a predictive model with a preoperative and a postoperative mode to predict survival of an individual patient after NSCLC surgery was created. This model combines the patient-, tumour- and treatment characteristics and can be used to assist in clinical decision making. Till present, this model has not been validated. The purpose of this study was to validate this model in patients operated on for primary NSCLC. METHODS: A total of 126 patients underwent surgery for primary NSCLC between January 2002 and December 2006. Required model variables were collected for all patients and inserted into the model. To evaluate the performance of the two models, we assessed these models in terms of both discrimination (resolution) and calibration (reliability). The discriminative ability was measured using the c-index and calibration was evaluated by the Hosmer-Lemeshow goodness-of-fit test. RESULTS: The median follow-up time was 3.4 years. Hospital mortality was 2.4%. One-, 2- and 3-year survival was 86%, 75% and 72%, respectively. The discriminative ability of the preoperative mode showed a c-statistic for 1-year survival of 0.68, for 2-year of 0.68 and for 3-year of 0.66. The postoperative model showed a discriminative ability for 1-year survival of 0.72, for 2-year of 0.76 and for 3-year of 0.77. Calibration was adequate for the first 2 years. The preoperative mode showed a p-value of 0.62 for 1-year survival and 0.14 for 2-year survival. Calibration was poor for 3-year survival (p=0.0027). For the postoperative mode, calibration was quite similar with p-values of 0.4 for 1-year survival, 0.14 for 2-year survival and 0.003 for 3-year survival. CONCLUSIONS: The model adequately estimates the 1- and 2-year survival. Discrimination was good for 3-year survival. Inclusion of more factors with additional prognostic value could potentially further improve the accuracy of the model.

Relationship between the logistic EuroSCORE and the Society of Thoracic Surgeons Predicted Risk of Mortality score in patients implanted with the CoreValve ReValving system--a Bern-Rotterdam Study.

BACKGROUND: Surgical risk scores, such as the logistic EuroSCORE (LES) and Society of Thoracic Surgeons Predicted Risk of Mortality (STS) score, are commonly used to identify high-risk or "inoperable" patients for transcatheter aortic valve implantation (TAVI). In Europe, the LES plays an important role in selecting patients for implantation with the Medtronic CoreValve System. What is less clear, however, is the role of the STS score of these patients and the relationship between the LES and STS. OBJECTIVE: The purpose of this study is to examine the correlation between LES and STS scores and their performance characteristics in high-risk surgical patients implanted with the Medtronic CoreValve System. METHODS: All consecutive patients (n = 168) in whom a CoreValve bioprosthesis was implanted between November 2005 and June 2009 at 2 centers (Bern University Hospital, Bern, Switzerland, and Erasmus Medical Center, Rotterdam, The Netherlands) were included for analysis. Patient demographics were recorded in a prospective database. Logistic EuroSCORE and STS scores were calculated on a prospective and retrospective basis, respectively. RESULTS: Observed mortality was 11.1%. The mean LES was 3 times higher than the mean STS score (LES 20.2% +/- 13.9% vs STS 6.7% +/- 5.8%). Based on the various LES and STS cutoff values used in previous and ongoing TAVI trials, 53% of patients had an LES > or =15%, 16% had an STS > or =10%, and 40% had an LES > or =20% or STS > or =10%. Pearson correlation coefficient revealed a reasonable (moderate) linear relationship between the LES and STS scores, r = 0.58, P < .001. Although the STS score outperformed the LES, both models had suboptimal discriminatory power (c-statistic, 0.49 for LES and 0.69 for STS) and calibration. CONCLUSIONS: Clinical judgment and the Heart Team concept should play a key role in selecting patients for TAVI, whereas currently available surgical risk score algorithms should be used to guide clinical decision making.

Outcome after reoperation for atrioventricular septal defect repair.

Results of surgical repair of atrioventricular septal defect (AVSD), both partial (PAVSD) and complete (CAVSD), have improved. However, reoperation is not uncommon. This report describes our experience in 59 patients who underwent reoperation after AVSD repair, between 1977 and 2008. Thirty-one patients had a PAVSD, 28 had a CAVSD. Mean interval between initial repair and reoperation was 10+/-11 years (PAVSD vs. CAVSD: 13+/-12 vs. 6+/-9 years, P=0.063). Reoperations were required for left atrioventricular valve regurgitation (LAVVR) in 53 patients (combined with right atrioventricular valve regurgitation in 10, atrial septal defect (ASD) in 11, ventricular septal defect (VSD) in 7, left ventricular outflow tract (LVOT) obstruction in 1, and aortic valve stenosis in 1), ASD in 3, and LVOT obstruction in 3. Valve repair was performed in 45 patients and replacement in 8. Repair techniques of the left-sided atrioventricular valve (LAVV) included cleft closure in 44 patients, commissuroplasty in 19, and annuloplasty in 1. Freedom from additional reoperation was 85%, and 80% at 5 and 15 years. Hospital mortality was 3%. Overall survival was 91%, and 86% after 5 and 15 years. The most common indication to undergo reoperation is LAVVR. Reoperation is safe and in the majority of cases, a durable repair of the LAVV can still be achieved.

Complexity of coronary vasculature predicts outcome of surgery for left main disease.

BACKGROUND: The SYNTAX score, a comprehensive angiographic scoring system, was recently developed as a tool for risk stratification during the SYNTAX trial (randomized trial comparing coronary artery bypass grafting with percutaneous coronary intervention). We applied the SYNTAX score in patients with left main coronary artery disease who underwent coronary artery bypass grafting to examine its role in predicting incidences of major adverse cardiac and cerebrovascular events (MACCE) within 30 days and 1 year. METHODS: One hundred forty-eight patients were studied. Their angiograms were scored according to the SYNTAX score. The MACCE-free survival curves were estimated by the Kaplan-Meier method. Univariate and multivariate analyses determined risk factors for MACCE. Performance of the SYNTAX score was studied with respect to discrimination by receiver-operating characteristic curves with their area under the curve (c-index). Classification and regression tree analysis was performed to identify the best outcome predictors and develop a risk stratification model. RESULTS: Overall SYNTAX score ranged from 11 to 53 (mean, 24 +/- 9). At 30 days and 1 year, 15 (10%) and 19 (13%) patients experienced MACCE. Patients with a higher SYNTAX score had a significantly (p < 0.0001) poorer MACCE-free survival. In multivariate analysis, SYNTAX score, female sex, and incomplete revascularization were associated with a higher rate of MACCE in 30 days. The SYNTAX score was the single predictor for MACCE in 1 year. The c-index of the SYNTAX score was 0.88 for 30 days and 0.90 for 1 year, respectively. The SYNTAX score was the best single discriminator between patients with and those without MACCE, with a discrimination level of 36.5. CONCLUSIONS: The SYNTAX score is the first coronary vasculature complexity score predictive for postoperative outcome in patients with left main coronary artery disease undergoing coronary artery bypass grafting. The outcomes of the ongoing SYNTAX trial will definitively define the role of the SYNTAX score in predicting short-term and long-term incidence of MACCE.

Seventeen years of adult congenital heart surgery: a single centre experience.

OBJECTIVE: With a growing number of children with congenital heart disease (CHD) reaching adulthood, an extensive experience with cardiac surgery in adults with CHD is accumulating. To increase insight in this patient category we report our 17-year single centre experience including predictors for adverse outcome and EuroSCORE performance. METHODS: Patients and operative characteristics of all consecutive adult CHD patients operated upon between January 1990 and January 2007 were collected. Categorisation was done according to the EACTS/STS congenital database. Early and late morbidity and mortality were assessed with follow-up extending up to 17 years. EuroSCORE performance was assessed. RESULTS: Nine hundred and sixty-three procedures were performed in 830 patients (mean age 39.3 years, 50.3% male). A total of 49% were re-do procedures, frequent procedures were for left heart lesions (37%), right heart lesions (31%) and septal defects (8%). The 51% primary procedures largely consisted of less complex procedures but also included 1.4% of tetralogy of Fallot repairs, 4.1% of aortic coarctation repairs and 2.7% of Ebstein's disease repairs. Thirty-day mortality was 1.5% (n=14); predicted mortality by logistic EuroSCORE was 4.6%. c-index was 0.61 (95% CI 0.46-0.75). Major complications such as tamponade requiring intervention occurred in 3.2%, postoperative bleeding requiring re-exploration in 7.1% and renal insufficiency requiring dialysis in 4 (0.4%). Pulmonary hypertension was a strong predictor for short-term mortality; impaired ventricular function and cyanosis for long-term mortality. Overall 17-year survival was 71% (95% CI 61%-82%). Eighty percent of patients were in NYHA class I at last follow-up, 17% in II, 3% in III, 0% in IV. CONCLUSIONS: Surgery in adult CHD patients can be performed with low operative mortality and good clinical outcome. EuroSCORE is not a good model for risk assessment in this group of patients.

Therapeutic decisions for patients with symptomatic severe aortic stenosis: room for improvement?

OBJECTIVE: Symptomatic severe aortic stenosis is an indication for aortic valve replacement. Some patients are denied intervention. This study provides insight into the proportion of conservatively treated patients and into the reasons why conservative treatment is chosen. METHODS: Of a patient cohort presenting with severe aortic stenosis between 2004 and 2007, medical records were retrospectively analyzed. Only symptomatic patients (n=179) were included. We studied their characteristics, treatment decisions, and survival. RESULTS: Mean age was 71 years, 50% were male. During follow-up (mean 17 months, 99% complete) 76 (42%) patients were scheduled for surgical treatment (63 conventional valve replacement, 10 transcatheter, 1 heart transplantation, 2 waiting list) versus 101 (56%) who received medical treatment. Reasons for medical treatment were: perceived high operative risk (34%), symptoms regarded mild (19%), stenosis perceived non-severe (14%), and patient preference (9%). In 5% the decision was pending at the time of the analysis and in 20% the reason was other/unclear. Mean age of the surgical group was 68 years versus 73 years for medically treated patients (p=0.004). Predicted mortality (EuroSCORE) was 7.8% versus 11.3% (p=0.006). During follow-up 12 patients died in the surgical group (no 30-day operative mortality), versus 28 in the medical group. Two-year survival was 90% versus 69%. CONCLUSIONS: A large proportion (56%) of symptomatic patients does not undergo aortic valve replacement. Often operative risk is estimated (too) high or hemodynamic severity and symptomatic status are misclassified. Interdisciplinary team discussions between cardiologists and surgeons should be encouraged to optimize patient selection for surgery.

A comparison of patient characteristics and 30-day mortality outcomes after transcatheter aortic valve implantation and surgical aortic valve replacement for the treatment of aortic stenosis: a two-centre study.

AIMS: It is unclear whether transcatheter aortic valve implantation (TAVI) addresses an unmet clinical need for those currently rejected for surgical aortic valve replacement (SAVR) and whether there is a subgroup of high-risk patients benefiting more from TAVI compared to SAVR. In this two-centre, prospective cohort study, we compared baseline characteristics and 30-day mortality between TAVI and SAVR in consecutive patients undergoing invasive treatment for aortic stenosis. METHODS AND RESULTS: We pre-specified different adjustment methods to examine the effect of TAVI as compared with SAVR on overall 30-day mortality: crude univariable logistic regression analysis, multivariable analysis adjusted for baseline characteristics, analysis adjusted for propensity scores, propensity score matched analysis, and weighted analysis using the inverse probability of treatment (IPT) as weights. A total of 1,122 patients were included in the study: 114 undergoing TAVI and 1,008 patients undergoing SAVR. The crude mortality rate was greater in the TAVI group (9.6% vs. 2.3%) yielding an odds ratio [OR] of 4.57 (95%-CI 2.17-9.65). Compared to patients undergoing SAVR, patients with TAVI were older, more likely to be in NYHA class III and IV, and had a considerably higher logistic EuroSCORE and more comorbid conditions. Adjusted OR depended on the method used to control for confounding and ranged from 0.60 (0.11-3.36) to 7.57 (0.91-63.0). We examined the distribution of propensity scores and found scores to overlap sufficiently only in a narrow range. In patients with sufficient overlap of propensity scores, adjusted OR ranged from 0.35 (0.04-2.72) to 3.17 (0.31 to 31.9). In patients with insufficient overlap, we consistently found increased odds of death associated with TAVI compared with SAVR irrespective of the method used to control confounding, with adjusted OR ranging from 5.88 (0.67-51.8) to 25.7 (0.88-750). Approximately one third of patients undergoing TAVI were found to be potentially eligible for a randomised comparison of TAVI versus SAVR. CONCLUSIONS: Both measured and unmeasured confounding limit the conclusions that can be drawn from observational comparisons of TAVI versus SAVR. Our study indicates that TAVI could be associated with either substantial benefits or harms. Randomised comparisons of TAVI versus SAVR are warranted.

Population characteristics, treatment assignment and survival of patients with aortic stenosis referred for percutaneous valve replacement.

AIMS: An increasing number of patients are referred for percutaneous aortic valve replacement (PAVR). Although case studies are available on outcome of selected patients, little is known about the demographics, treatment assignment and survival of the total referred population. METHODS AND RESULTS: This was a prospective observational cohort study. From September 2005 to September 2007, 100 patients were referred for PAVR of whom 39 underwent PAVR, 14 surgical valve replacement (AVR) and three balloon valvuloplasty (PABV). Another 16 refused treatment and 28 were no candidate (non severe aortic stenosis [n=11], asymptomatic and normal ventricular function [n=3], comorbidity [n=12], technically PAVR not feasible [n=2]). The logistic EuroSCORE (Mean, sd) was: 15 +/- 6% (PAVR), 9 +/- 11% (AVR), 22 +/- 15% (PABV), 25 +/- 14% (refusals) and 17 +/- 12% (no-candidate). The mean follow-up was 13 months (range 0-30 months). Cumulative survival at six months was 97%, 85% and 70%, for PAVR, AVR and refusals, respectively. At 12 months, it was 87%, 62% and 40% respectively. CONCLUSIONS: Not all patients referred for PAVR finally receive it. Approximately 15% of the patients received AVR and 30% were considered not eligible. This may reflect the lack of sufficient data and need for an improvement in the technology in order to offer PAVR to both lower and higher risk patients. Considering risk and outcome, it is conceivable that patients who refused treatment could have benefited the most from it.