Arie-Pieter Kappetein

Validation of the Charlson comorbidity index in patients with operated primary non-small cell lung cancer.

OBJECTIVE To validate the influence of the Charlson comorbidity index (CCI) in patients with operated primary non-small cell lung cancer. METHODS From January 1996 to December 2001, 205 consecutive resections for non-small cell lung cancer were performed at the Erasmus Medical Center Rotterdam. The patients ranged in age from 29 to 82 years, with a mean age of 64 years. In a retrospective study, each patient was scaled according to the CCI and the complications of surgery were determined. RESULTS The hospital mortality was 2.4% (5/205). Of the 205 patients 167 (32.7%) experienced minor complications and 32 (15.6%) major complications. In univariate analysis, gender, grades 3-4 of the CCI, any prior tumor treated in the last 5 years and chronic pulmonary disease were significant predictors of adverse outcome. Multivariate analysis showed that only grades 3-4 of the CCI was predictive (odds ratio=9.8; 95% confidence interval=2.1-45.9). Although only comorbidity grades 3-4 was a significant predictor, for every increase of the comorbidity grade the relative risk of adverse outcome showed a slight increase. CONCLUSION The CCI is strongly correlated with higher risk of surgery in primary non-small cell lung cancer patients and is a better predictor than individual risk factors.

Early echocardiographic evaluation following percutaneous implantation with the self-expanding CoreValve Revalving System aortic valve bioprosthesis.

AIMS Although safety and feasibility studies have been published, there are few reports dedicated to the echocardiographic evaluation of patients following percutaneous aortic valve replacement (PAVR). This report describes the early echocardiographic evaluation of patients undergoing PAVR with the CoreValve Revalving System. METHODS AND RESULTS The population consisted of 33 consecutive patients with aortic stenosis who underwent successful PAVR. Echocardiograms were performed pre-treatment (123+/-110 days prior), post-treatment (6+/-2 days) and post-discharge (80+/-64 days). Aortic valve function and left ventricular dimensions, systolic and diastolic function were assessed pre- and post-implantation. The mean age was 81+/-7 years and the mean Logistic Euroscore was 20+/-12. Following PAVR, the mean transaortic valve gradient decreased (46+/-16 mmHg pre-treatment vs. 12+/-7 mmHg post-treatment vs. 9+/-5 mmHg post-discharge, p<0.001) and the mean effective orifice area increased (0.75+/-0.23 cm2 pre-treatment vs. 1.97+/-0.85 cm2 post-treatment vs. 1.72+/-0.45 cm2 post-discharge, p<0.001). There was no significant change in mean ejection fraction (41+/-12% pre-treatment vs. 46+/-15% post-treatment vs. 44+/-13% post-discharge, p=0.44). Approximately two-thirds of patients had no change in diastolic function at follow-up. CONCLUSION Following implantation, there was a sustained decrease in aortic valve gradient and increase in aortic valve area. In addition, the mean ejection fraction did not change significantly and in the majority of patients, diastolic function was unchanged.

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.

Brom's three-patch technique for repair of supravalvular aortic stenosis

OBJECTIVE Case histories of all patients (n = 29) operated on for supravalvular aortic stenosis from 1962 to the present were reviewed to study different techniques and outcomes. The technique of symmetric aortoplasty with 3 patches (1 in each sinus) is described and compared with other methods. METHODS Case reports were reviewed and follow-up was completed by contacting the patients (pediatric) cardiologist. We aimed for a last follow-up visit, including Doppler echocardiographic studies, in a period no more than 12 months earlier than December 1997. Supravalvular aortic stenosis was discrete in 25 and diffuse with involvement of the aortic arch and arch vessels in 4 patients. Additional anomalies were bicuspid aortic valve (n = 5), coarctation (n = 3), ascending aortic aneurysm (n = 1), mitral valve insufficiency (n = 2), pulmonary valvular stenosis (n = 1), and peripheral pulmonary artery stenosis (n = 2). Eleven patients had Williams syndrome and 1 patient had Noonan syndrome. Symmetric aortoplasty with 3 patches (1 in each sinus) was used in 13 patients, whereas other nonsymmetric methods (1, 2, or Y-shaped patches) were used in 16 patients. Mean follow-up was 10.5 years (range: 4 months-36 years). RESULTS All techniques adequately decreased the pressure gradient. Progression of preoperative aortic valve insufficiency or de novo regurgitation was not observed except in 1 patient in whom the patches inserted were too large. CONCLUSIONS No difference could be demonstrated in outcome for any surgical technique; however, reconstruction of the aortic root with autologous pericardial patches in each sinus after transection of the aorta has the advantage of symmetry while restoring the normal aortic root anatomy.

Prosthesis-patient mismatch after transcatheter aortic valve implantation with the medtronic CoreValve system in patients with aortic stenosis.

A prosthesis-patient mismatch (PPM) is present when the prosthetic valve is too small in relation to the patients body size. The purpose of the present study was to investigate the frequency of PPM after the implantation of the Medtronic CoreValve System, and its relation to the clinical outcome. The indexed effective orifice area (EOA) was measured in 74 patients with symptomatic severe aortic stenosis, who had undergone successful transcatheter aortic valve implantation with the Medtronic CoreValve System, at baseline and discharge. PPM was defined as severe (indexed EOA <0.65 cm(2)/m(2)) or moderate (indexed EOA 0.65 to 0.85 cm(2)/m(2)). The indexed EOA increased from 0.35 +/- 0.13 to 0.97 +/- 0.34 cm(2)/m(2) after transcatheter aortic valve implantation (p <0.001) and was accompanied by significant clinical improvement. Severe and moderate PPMs were found in 16% and 23% of patients, respectively. Patients with severe PPM were more symptomatic and had a smaller indexed EOA at baseline than those with moderate or no PPM (0.28 +/- 0.09 vs 0.36 +/- 0.12 cm(2)/m(2), p <0.05). Functional status and mortality at 30 days and 6 months was not significantly different between the patients with severe PPM and those with moderate or no PPM. In conclusion, the indexed EOA increased significantly after transcatheter aortic valve implantation. Severe PPM was observed in 16% of the patients and was not associated with the clinical outcome.

Persistent annual permanent pacemaker implantation rate after surgical aortic valve replacement in patients with severe aortic stenosis

BACKGROUND Degenerative aortic valve stenosis (AS) is associated with conduction abnormalities. Pacemaker implantation is encountered after surgical aortic valve replacement (SAVR). Not much is known about the pacemaker implantation rate during midterm follow-up after SAVR. Our objectives were to determine the incidence of permanent pacemaker implantation (PPI) in the midterm after SAVR in a tertiary care facility. METHODS We reviewed procedural data of 734 consecutive patients (56% men; mean age, 68.9±9.5 years) with degenerative severe AS who underwent SAVR between January 1, 2003, and December 31, 2008. Perioperative electrocardiograms were assessed for occurrence of conduction abnormalities, and we sought to determine the incidence and indication for PPI with a median follow-up of 3.76 years (interquartile range, 2.44 to 5.59 years). Univariate and multivariate logistic regression models were applied to identify predictors for early (≤30 days) and late (>30 days) PPI. RESULTS Isolated SAVR was performed in 56%, SAVR with coronary artery bypass grafting in 35%, and SAVR with any other valve therapy in 5.8%. Complete bundle branch block (BBB) was present in 7% and first-degree atrioventricular block in 11%. New BBBs were detected in 63 patients (8.6%). Fifteen patients (2.0%) required a PPI within 30 days after SAVR, and 28 (4.0%) underwent PPI more than 30 days after SAVR. The linearized rate of PPI after SAVR was 1.01%±0.37% per patient-year. Patients with BBB at baseline had a higher PPI incidence after SAVR than patients without BBB, both within 30 days (8% vs 1.5%, p=0.001) and after 30 days (10% vs 2.9%, p=0.006). PPI incidence after 30 days was also significantly higher in patients with a new BBB after SAVR (7.8% vs 2.9%, p=0.038). By multivariate logistic regression analysis, BBB and the combination of AS and regurgitation predicted PPI within 30 days after SAVR (hazard ratio [HR], 470; 95% confidence interval [CI], 1.55 to 14.27; and HR, 1.33; 95% CI, 0.03 to 1.73, respectively). BBB (HR, 3.26; 95% CI, 1.41 to 7.54), previous cardiac operation (HR, 3.40; 95% CI, 1.16 to 9.94), and severe left ventricular dysfunction (HR, 9.82; 95% CI, 2.90 to 33.26) were predictors for PPI after 30 days post-SAVR. CONCLUSIONS Patients with severe AS who underwent SAVR have a persistent 1% annual risk for PPI. Postoperative presence of BBB predicted the need for PPI both within 30 days and after 30 days after SAVR.

Two cases of aneurysm of the anterior mitral valve leaflet associated with transcatheter aortic valve endocarditis: A mere coincidence?

From the Division of Cardiology, Erasmus MC, Thoraxcenter, Rotterdam, The Netherlands; the Division of Cardiology, University of Turin, San Giovanni Battista Hospital, Turin, Italy; the Division of Cardiology, St Paul’s Hospital, Vancouver, British Columbia, Canada; the Division of Cardiac Surgery, University of Turin, San Giovanni Battista Hospital, Turin, Italy; and the Division of Cardiac Surgery, Erasmus MC, Thoraxcenter, Rotterdam, The Netherlands. Disclosures: None. Received for publication Nov 1, 2009; accepted for publication Nov 6, 2009; available ahead of print Feb 18, 2010. Address for reprints: Patrick W. Serruys, MD, PhD, FACC, Ba 583, Thoraxcenter, Erasmus Medical Center, Molewaterplein 40, 3015 GD, Rotterdam, The Netherlands (E-mail: p.w.j.c.serruys@erasmusmc.nl). J Thorac Cardiovasc Surg 2010;140:e36-8 0022-5223/

Cause of death after transcatheter aortic valve implantation

36.00 Copyright 2010 by The American Association for Thoracic Surgery doi:10.1016/j.jtcvs.2009.11.012

Rationale and design of the Transcatheter Aortic Valve Replacement to UNload the Left ventricle in patients with ADvanced heart failure (TAVR UNLOAD) trial

To evaluate survival and cause of death in a consecutive patient cohort undergoing Transcatheter Aortic Valve implantation (TAVI).

EACTS guidelines for the use of patient safety checklists

BACKGROUND Coexistence of moderate aortic stenosis (AS) in patients with heart failure (HF) with reduced ejection fraction is not uncommon. Moderate AS increases afterload, whereas pharmacologic reduction of afterload is a pillar of contemporary HF management. HYPOTHESIS Unloading the left ventricle by reducing the transaortic gradient with transfemoral transcatheter aortic valve replacement (TAVR) may improve clinical outcomes in patients with moderate AS and HF with reduced ejection fraction. STUDY DESIGN The TAVR UNLOAD (NCT02661451) is an international, multicenter, randomized, open-label, clinical trial comparing the efficacy and safety of TAVR with the Edwards SAPIEN 3 Transcatheter Heart Valve in addition to optimal heart failure therapy (OHFT) vs OHFT alone in patients with moderate AS (defined by a mean transaortic gradient ≥20 mm Hg and <40 mm Hg, and an aortic valve area >1.0 cm2 and ≤1.5 cm2 at rest or after dobutamine stress echocardiography) and reduced ejection fraction. A total of 600 patients will be randomized in a 1:1 fashion. Clinical follow-up is scheduled at 1, 6, and 12 months, and 2 years after randomization. The primary end point is the hierarchical occurrence of all-cause death, disabling stroke, hospitalizations related to HF, symptomatic aortic valve disease or nondisabling stroke, and the change in the Kansas City Cardiomyopathy Questionnaire at 1 year. Secondary end points capture effects on clinical outcome, biomarkers, echocardiographic parameters, and quality of life. SUMMARY The TAVR UNLOAD trial aims to test the hypothesis that TAVR on top of OHFT improves clinical outcomes in patients with moderate AS and HF with reduced ejection fraction.