Floortje van Kesteren

Filter-based cerebral embolic protection with transcatheter aortic valve implantation: the randomised MISTRAL-C trial

AIMS Our aim was to determine whether use of the filter-based Sentinel™ Cerebral Protection System (CPS) during transcatheter aortic valve implantation (TAVI) can affect the early incidence of new brain lesions, as assessed by diffusion-weighted magnetic resonance imaging (DW-MRI), and neurocognitive performance. METHODS AND RESULTS From January 2013 to July 2015, 65 patients were randomised 1:1 to transfemoral TAVI with or without the Sentinel CPS. Patients underwent DW-MRI and extensive neurological examination, including neurocognitive testing one day before and five to seven days after TAVI. Follow-up DW-MRI and neurocognitive testing was completed in 57% and 80%, respectively. New brain lesions were found in 78% of patients with follow-up MRI. Patients with the Sentinel CPS had numerically fewer new lesions and a smaller total lesion volume (95 mm3 [IQR 10-257] vs. 197 mm3 [95-525]). Overall, 27% of Sentinel CPS patients and 13% of control patients had no new lesions. Ten or more new brain lesions were found only in the control cohort (in 20% vs. 0% in the Sentinel CPS cohort, p=0.03). Neurocognitive deterioration was present in 4% of patients with Sentinel CPS vs. 27% of patients without (p=0.017). The filters captured debris in all patients with Sentinel CPS protection. CONCLUSIONS Filter-based embolic protection captures debris en route to the brain in all patients undergoing TAVI. This study suggests that its use can lead to fewer and overall smaller new brain lesions, as assessed by MRI, and preservation of neurocognitive performance early after TAVI. CLINICAL TRIAL REGISTRATION Dutch trial register-ID: NTR4236. URL http://www.trialregister.nl/trialreg/admin/rctsearch.asp?Term=mistral.

Impact of Aortic Valve Stenosis on Coronary Hemodynamics and the Instantaneous Effect of Transcatheter Aortic Valve Implantation

Background—Aortic valve stenosis (AS) induces compensatory alterations in left ventricular hemodynamics, leading to physiological and pathological alterations in coronary hemodynamics. Relief of AS by transcatheter aortic valve implantation (TAVI) decreases ventricular afterload and is expected to improve microvascular function immediately. We evaluated the effect of AS on coronary hemodynamics and the immediate effect of TAVI. Methods and Results—Intracoronary pressure and flow velocity were simultaneously assessed at rest and at maximal hyperemia in an unobstructed coronary artery in 27 patients with AS before and immediately after TAVI and in 28 patients without AS. Baseline flow velocity was higher and baseline microvascular resistance was lower in patients with AS as compared with controls, which remained unaltered post-TAVI. In patients with AS, hyperemic flow velocity was significantly lower as compared with controls (44.5±14.5 versus 54.3±18.6 cm/s; P=0.04). Hyperemic microvascular resistance (expressed in mm Hg·cm·s−1) was 2.10±0.69 in patients with AS as compared with 1.80±0.60 in controls (P=0.096). Coronary flow velocity reserve in patients with AS was lower, 1.9±0.5 versus 2.7±0.7 in controls (P<0.001). Improvement in coronary hemodynamics after TAVI was most pronounced in patients without post-TAVI aortic regurgitation. In these patients (n=20), hyperemic flow velocity increased significantly from 46.24±15.47 pre-TAVI to 56.56±17.44 cm/s post-TAVI (P=0.003). Hyperemic microvascular resistance decreased from 2.03±0.71 to 1.66±0.45 (P=0.050). Coronary flow velocity reserve increased significantly from 1.9±0.4 to 2.2±0.6 (P=0.009). Conclusions—The vasodilatory reserve capacity of the coronary circulation is reduced in AS. TAVI induces an immediate decrease in hyperemic microvascular resistance and a concomitant increase in hyperemic flow velocity, resulting in immediate improvement in coronary vasodilatory reserve.

An up-to-date overview of the most recent transcatheter implantable aortic valve prostheses

Over the past decade transcatheter aortic valve implantation (TAVI) has evolved towards the routine therapy for high-risk patients with severe aortic valve stenosis. Technical refinements in TAVI are rapidly evolving with a simultaneous expansion of the number of available devices. This review will present an overview of the current status of development of TAVI-prostheses; describes the technical features and applicability of each device and the clinical data available.

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-PROM ≤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, p = 0.344) and STS-PROM risk score (3.862 vs 3.992, p = 0.154) did not differ between the ES3 and SXT group. ES3-treated patients showed favorable procedural outcomes, with significantly higher device success (90% vs 73%, p <0.0001) and less paravalvular leakage (7% vs 13%, p <0.0001). Procedural mortality (0.87% vs 1.45%, p = 0.245) and the very low rate of permanent pacemaker implantations (7.4% vs 6.1%, p = 0.234) did not differ significantly. Three-year survival was 87% in the ES3 vs 80% in the SXT group (log-rank p = 0.385). 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.

Automated CTA based measurements for planning support of minimally invasive aortic valve replacement surgery

Minimally invasive aortic valve replacement (mini-AVR) procedures are a valuable alternative to conventional open heart surgery. Currently, planning of mini-AVR consists of selection of the intercostal space closest to the sinotubular junction on preoperative computer tomography images. We developed an automated algorithm detecting the sinotubular junction (STJ) and intercostal spaces for finding the optimal incision location. The accuracy of the STJ detection was assessed by comparison with manual delineation by measuring the Euclidean distance between the manually and automatically detected points. In all 20 patients, the intercostal spaces were accurately detected. The median distance between automated and manually detected STJ locations was 1.4 [IQR= 0.91-4.7] mm compared to the interobserver variation of 1.0 [IQR= 0.54-1.3] mm. For 60% of patients, the fourth intercostal space was the closest to the STJ. The proposed algorithm is the first automated approach for detecting optimal incision location and has the potential to be implemented in clinical practice for planning of various mini-AVR procedures.

PREVENTION OF CONTRAST-INDUCED NEPHROPATHY FOR COMPUTED TOMOGRAPHY (CT)-SCANNING IN TAVR WORK-UP: ONE-HOUR HYDRATION WITH SODIUM BICARBONATE IS NOT INFERIOR TO 24-HOUR SALINE HYDRATION

Background: Computed tomography-angiography (CTA) is required in work-up for Transcatheter Aortic Valve Replacement (TAVR). In patients with impaired renal function CTA can cause contrast-induced nephropathy (CIN). The standard protocol for prevention of CIN in patients with heart failure is iv

Impact of Potentially Malignant Incidental Findings by Computed Tomographic Angiography on Long-Term Survival After Transcatheter Aortic Valve Implantation

Computed tomography angiography (CTA) in workup for transcatheter aortic valve implantation (TAVI) frequently reveals potentially malignant incidental findings. Most incidental findings provoke discussions on their influence. We aimed to analyze if these findings were a predictor of long-term survival after TAVI. In a single-center retrospective analysis, all consecutive patients with pre-TAVI CTA were included (years 2009 to 2014). Patients were divided by presence or absence of incidental findings. We analyzed up to 5 years of all-cause, non-cardiovascular and cardiovascular mortality for all 553 patients who underwent TAVI; 113 had a potentially malignant incidental finding (20.4%). At 5 years, all-cause mortality risk was 64.5% in patients with versus 49.1% in patients without a finding (hazard ratio [HR] 1.70, 95% confidence interval [CI] 1.25 to 2.31). After adjustment, the findings remained an independent predictor of all-cause (adjusted HR 1.46, 95% CI 1.07 to 1.99) and non-cardiovascular mortality (adjusted subdistribution HR 1.84, 95% CI 1.06 to 3.20), but not of cardiovascular mortality. In conclusion, the presence of potentially malignant incidental findings on CTA is an independent predictor of long-term all-cause and noncardiovascular mortality but not of cardiovascular mortality.

Thromboembolic events after transcatheter aortic valve implantation

Dear editor, Thromboembolic events are a major complication after transcatheter aortic valve implantation (TAVI), with a reported 30-day incidence of 3.2% for major stroke. The occurrence in half of these events within one week suggests a procedure-related cause. To elucidate the origin of thrombus causing stroke after TAVI, we report the histopathologic analysis of thrombectomy material in three cases.

Automatic Planning of Minimally Invasive Aortic Valve Replacement Surgery

The minimally invasive aortic valve replacement procedure provides a good alternative to conventional open heart surgery. Currently, Planning of the mini-AVR is supported by the selection of closest intercostal space to the sinutubular junction manually. In this work, we automate and standardize this planning by automatically detecting the intercostal spaces and the sinutubular junction, from which we calculate the closest incision location. The proposed algorithm provides qualitatively and quantitative accurate results; where the sinutubular junction detection has mean error of 3.4 mm. This work has the potential to be implemented in the clinical practice for reproducible and accurate mini-AVR planning.

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 1 year. 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 1 year 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.