Jeroen Vendrik

A Randomized Comparison of Paclitaxel-Eluting Balloon Versus Everolimus-Eluting Stent for the Treatment of Any In-Stent Restenosis: The DARE Trial

OBJECTIVESnThe authors sought to evaluate the relative performance of a drug-eluting balloon (DEB) and a drug-eluting stent (DES) in patients with any (bare-metal or drug-eluting stent) in-stent restenosis (ISR).nnnBACKGROUNDnThe treatment of ISR remains challenging in contemporary clinical practice.nnnMETHODSnIn a multicenter randomized noninferiority trial, patients with any ISR were randomly allocated in a 1:1 fashion to treatment with a DEB (SeQuent Please paclitaxel-eluting balloon, B. Braun Melsungen, Melsungen, Germany), or a DES (XIENCE everolimus-eluting stent, Abbott Vascular, Santa Clara, California). The primary endpoint was noninferiority in terms of in-segment minimal lumen diameter (MLD) at 6-month angiographic follow-up. Secondary endpoints included angiographic parameters at 6 months and clinical follow-up up to 12 months.nnnRESULTSnA total of 278 patients, of whom 56% had DES-ISR, were randomized at 8 sites to treatment with DEB (nxa0=xa0141) or DES (nxa0= 137). As compared with DEB, DES was associated with larger MLD and lower % stenosis immediately post-procedure (1.84 ± 0.46 vs. 1.72 ± 0.35; pxa0= 0.018; and 26 ± 10% vs. 30 ± 10%; pxa0= 0.03). Angiographic follow up was completed at 196 ± 53 days in 79% of patients. With respect to the primary endpoint of in-segment MLD at 6xa0months, DEB was noninferior to DES (DEB 1.71 ± 0.51 mm vs. DES 1.74 ± 0.61 mm; p for noninferiorityxa0<0.0001). Target vessel revascularization at 12-month follow-up was similar in both groups (DES 7.1% vs. DEB 8.8%; pxa0= 0.65).nnnCONCLUSIONSnIn patients with ISR, treatment with DEB was noninferior compared with DES in terms of 6-month MLD. There were no differences in clinical endpoints, including target vessel revascularization up to 12 months. Therefore, usexa0of a DEB is an attractive treatment option for in-stent restenosis, withholding the need for additional stent implantation.

Cerebral protection devices during transcatheter aortic valve implantation

Transcatheter aortic valve implantation (TAVI) in patients with aortic valve stenosis is associated with an improvement of clinical outcomes, quality of life, and self-sufficiency. The most feared TAVI-related complication is the occurrence of stroke. In order to reduce peri-procedural cerebral embolizations, diverse cerebral protection devices have been developed. These devices work though deflection or filtering of emboli, and are in different stages of testing. Silent cerebral infarctions identified by diffusion-weighted magnetic resonance imaging (DW-MRI) are used as surrogate primary outcomes, but the clinical significance is still unclear. This review provides a synopsis of the diverse cerebral protection devices and summarizes the current evidence on their efficacy during TAVI.

Trends in patient characteristics and clinical outcome over 8 years of transcatheter aortic valve implantation

AimIn the evolving field of transcatheter aortic valve implantations (TAVI) we aimed to gain insight into trends in patient and procedural characteristics as well as clinical outcome over an 8‑year period in axa0real-world TAVI population.MethodsWe performed axa0single-centre retrospective analysis of 1,011 consecutive patients in axa0prospectively acquired database. We divided the cohort into tertiles of 337 patients; first interval: January 2009–March 2013, second interval: March 2013–March 2015, third interval: March 2015–October 2016.ResultsOver time, axa0clear shift in patient selection was noticeable towards lower surgical risks including Society of Thoracic Surgeons predicted risk of mortality score and comorbidity. The frequency of transfemoral TAVI increased (from 66.5 to 77.4%, pu202f=u20090.0015). Device success improved (from 62.0 to 91.5%, pu202f<u20090.0001) as did the frequency of symptomatic relief (≥1xa0New York Heart Association class difference) (from 73.8 to 87.1%, pu202f=u20090.00025). Complication rates decreased, including in-hospital stroke (from 5.0 to 2.1%, pu202f=u20090.033) and pacemaker implantations (from 10.1 to 5.9%, pu202f=u20090.033). Thirty-day mortality decreased (from 11.0 to 2.4%, pu202f<u20090.0001); after adjustment for patient characteristics, axa0mortality-risk reduction of 72% was observed (adjusted hazard ratio [HR]: 0.28, 95% confidence interval [CI]: 0.13–0.62). One-year mortality rates decreased (from 23.4 to 11.4%), but this was no longer significant after axa0landmark point was set at 30xa0days (mortality from 31xa0days until 1xa0year) (adjusted HR: 0.69, 95% CI: 0.41–1.16, pu202f=u20090.16).ConclusionAxa0clear shift towards axa0lower-risk TAVI population and improved clinical outcome was observed over an 8‑year period. Survival after TAVI improved impressively, mainly as axa0consequence of decreased 30-day mortality.

Procedural Outcome and Midterm Survival of Lower Risk Transfemoral Transcatheter Aortic Valve Implantation Patients Treated With the SAPIEN XT or SAPIEN 3 Device

Over the years increasing experience and technical device improvements in transcatheter aortic valve implantation (TAVI) have led to treatment of patients with lower surgical risks. Specifically for this population, device performance and longer term outcome are of great importance. In this single center, we performed a retrospective analysis of 515 consecutive patients with low- to intermediate surgical risk (STS-PROMu2009≤8), who underwent transfemoral TAVI between January 2009 and February 2017 with the SXT and ES3 prostheses, and we assessed procedural outcome and procedural and 3-year survival. Mean age (82 years in both groups, pu2009=u20090.344) and STS-PROM risk score (3.862 vs 3.992, pu2009=u20090.154) did not differ between the ES3 and SXT group. ES3-treated patients showed favorable procedural outcomes, with significantly higher device success (90% vs 73%, pu2009<0.0001) and less paravalvular leakage (7% vs 13%, pu2009<0.0001). Procedural mortality (0.87% vs 1.45%, pu2009=u20090.245) and the very low rate of permanent pacemaker implantations (7.4% vs 6.1%, pu2009=u20090.234) did not differ significantly. Three-year survival was 87% in the ES3 vs 80% in the SXT group (log-rank pu2009=u20090.385). In conclusion, we showed excellent survival and procedural outcomes in patients receiving a transfemoral TAVI with either the SAPIEN 3 or the SAPIEN XT device. The newer SAPIEN 3 even outperforms the SAPIEN XT in terms of less major bleeding complications, substantially higher device success rates, and less paravalvular leakage, with the permanent pacemaker implantation rate being very low in both groups. Survival curves show a nonsignificant trend toward better midterm survival in the ES3 group.

Guideline-defined futility or patient-reported outcomes to assess treatment success after TAVI: what to use? Results from a prospective cohort study with long-term follow-up

Objective Transcatheter aortic valve implantation (TAVI) provides a significant symptom relief and mortality reduction in most patients; however, a substantial group of patients does not experience the same beneficial results according to physician-determined outcomes. Methods Single-centre prospective design; the population comprises all consecutive patients undergoing TAVI in 2012–2017. TAVI futility was defined as the combined endpoint of either no symptomatic improvement or mortality at 1u2009year. We actively gathered telephone follow-up using a predefined questionnaire. Results Guideline defined TAVI futility was present in 212/741 patients. Multivariate regression showed lower albumin and non-transfemoral approach to be predictive for futility. In addition to these, chronic obstructive pulmonary disease, lower estimated glomerular filtration rate, atrial fibrillation, low-flow–low-gradient aortic stenosis and lower Body Mass Index were predictive for 1-year mortality. Patients who showed symptomatic benefit estimated the percentage in which their symptoms were remedied higher than patients who did not (80% vs 60%, p<0.001). Guideline-defined TAVI futility occurs frequently, contrasting with patient-reported outcome measures (PROMs). The vast majority in both groups would again choose for TAVI treatment. Conclusion Lower albumin and non-transfemoral access route were predictors for guideline-defined TAVI futility, defined as mortality within 1u2009year or no objective symptomatic improvement in New York Heart Association class. Futility according to this definition occurred frequently in this study, contrasting with much more positive PROMs. The majority of patients would undergo a TAVI again, underlining the patients’ experienced value of TAVI and putting the definition of TAVI futility further on debate. In the near future, less-strict criteria for TAVI futility, that is, using a shorter warranted life expectancy and incorporating patients’ perceived outcomes, should be used.

CTCA for detection of significant coronary artery disease in routine TAVI work-up: A systematic review and meta-analysis

Transcatheter aortic valve implantation (TAVI) has evolved to standard treatment of severe aortic stenosis in patients with an intermediate to high surgical risk. Computed tomography coronary angiography (CTCA) could partially replace invasive coronary angiography to diagnose significant coronary artery disease in the work-up for TAVI. Axa0literature search was performed in MEDLINE and EMBASE for papers comparing CTCA and coronary angiography in TAVI candidates. The primary endpoint was the diagnostic accuracy of CTCA, compared to coronary angiography, for detection of significant (>50% diameter stenosis) coronary artery disease, measured as sensitivity, specificity, positive—(PPV) and negative predictive value (NPV). Seven studies were included, with axa0cumulative sample size of 1,275 patients. The patient-based pooled sensitivity, specificity, PPV and NPV were 95, 65, 71 and 94% respectively. Quality assessment revealed excellent and good quality in terms of applicability and risk of bias respectively, with the main concern being patient selection. In conclusion, on the basis of axa0significance cut-off value of 50% diameter stenosis, CTCA provides acceptable diagnostic accuracy for the exclusion of coronary artery disease in patients referred for TAVI. Using the routinely performed preoperative computed tomography scans as axa0gatekeeper for coronary angiography could decrease additional coronary angiographies by 37% in this high-risk and fragile population.

Transcatheter aortic valve replacement alters ascending aortic blood flow and wall shear stress patterns: A 4D flow MRI comparison with age-matched, elderly controls

BackgroundWith the implementation of transcatheter aortic valve replacement (TAVR) in lower-risk patients, evaluation of blood flow characteristics and the effect of TAVR on aortic dilatation becomes of considerable interest. We employed 4D flow MRI in the ascending aorta of patients after TAVR to assess wall shear stress (WSS) and compare blood flow patterns with surgical aortic valve replacement (SAVR) and age- and gender-matched controls.MethodsFourteen post-TAVR patients and ten age- and gender-matched controls underwent kt-PCA accelerated 4D flow MRI of the thoracic aorta at 3.0 Tesla. Velocity and wall shear stress was compared between the two groups. In addition, aortic flow eccentricity and displacement was assessed and compared between TAVR patients, controls and 14 SAVR patients recruited as part of an earlier study.ResultsCompared to controls, abnormally elevated WSS was present in 30±10% of the ascending aortic wall in TAVR patients. Increased WSS was present along the posterior mid-ascending aorta and the anterior distal-ascending aorta in all TAVR patients. TAVR results in eccentric and displaced flow in the mid- and distal-ascending aorta, whereas blood flow displacement in SAVR patients occurs only in the distal-ascending aorta.ConclusionThis study shows that TAVR results in increased blood flow velocity and WSS in the ascending aorta compared to age- and gender-matched elderly controls. This finding warrants longitudinal assessment of aortic dilatation after TAVR in the era of potential TAVR in lower-risk patients. Additionally, TAVR results in altered blood flow eccentricity and displacement in the mid- and distal-ascending aorta, whereas SAVR only results in altered blood flow eccentricity and displacement in the distal-ascending aorta.Key Points• TAVR results in increased blood flow velocity and WSS in the ascending aorta.• Longitudinal assessment of aortic dilatation after TAVR is warranted in the era of potential TAVR in lower-risk patients.• Both TAVR and SAVR result in altered blood flow patterns in the ascending aorta when compared to age-matched controls.

Paclitaxel-eluting balloon versus everolimus-eluting stent in patients with diabetes mellitus and in-stent restenosis: Insights from the randomized DARE trial

To investigate the relative performance of treatment with a paclitaxel‐eluting balloon (PEB) compared with an everolimus‐eluting stent (EES) for in‐stent restenosis (ISR) in patients with diabetes mellitus (DM).

CT determined psoas muscle area predicts mortality in women undergoing transcatheter aortic valve implantation

The aim of this study was to assess the predictive value of PMA measurement for mortality.

Incidence, Predictors, and Impact of Vascular Complications After Transfemoral Transcatheter Aortic Valve Implantation With the SAPIEN 3 Prosthesis

Vascular complications (VCs) after transfemoral transcatheter aortic valve implantation (TAVI) have always been reported to occur frequently. Studies addressing VCs have been conducted with older-generation prostheses. We aimed to evaluate the incidence, predictors, and impact of VCs after transfemoral TAVI with the balloon-expandable SAPIEN 3. We report a single-center retrospective analysis of 400 consecutive patients of a prospectively acquired cohort. All patients underwent transfemoral TAVI with SAPIEN 3 between January 2014 and December 2016. VC was defined according to the Valve Academic Research Consortium. In this cohort 83 patients had VCs (20.8%), 5.8% major and 15.0% minor. Sheath-to-iliofemoral artery ratio was the only predictor of major VCs (odds ratio 7.51, 95% confidence interval 1.61 to 34.95, pu2009=u20090.010). The area under the receiver-operator characteristic curve for sheath-to-iliofemoral artery ratio was 0.63 (poor accuracy). Thirty-day mortality rates were 17.4%, 1.7%, and 0.6% for major, minor, and no VCs, respectively (log-rank p ≤0.001). After adjustment, only major VCs were associated with 30-day mortality (adjusted hazard ratio 48.31, 95% confidence interval 7.80 to 299.24). Mortality from 30 days until 1 year did not differ between patients with and without VCs (log-rank pu2009=u20090.61). In conclusion we report that VCs remain an issue of transfemoral TAVI with the SAPIEN 3, and their prediction continues to be difficult, albeit the low-incidence, major VCs were associated with higher 30-day mortality. However, after these first 30 days, they were not of influence on survival anymore.