The evolution of technical prerequisites and local boundary conditions for optimization of mitral valve interventions-Emphasis on skills development and institutional risk performance.

This viewpoint report describes how the evolution of transcatheter mitral valve intervention (TMVI) is influenced by lessons learned from three evolutionary tracks: (1) the development of treatment from mitral valve surgery (MVS) to transcutaneous procedures; (2) the evolution of biomedical engineering for research and development resulting in predictable and safe clinical use; (3) the adaptation to local conditions, impact of transcatheter aortic valve replacement (TAVR) experience and creation of infrastructure for skills development and risk management. Thanks to developments in computer science and biostatistics, an increasing number of reports regarding clinical safety and effectiveness is generated. A full toolbox of techniques, devices and support technology is now available, especially in surgery. There is no doubt that the injury associated with a minimally invasive access reduces perioperative risks, but it may affect the effectiveness of the treatment due to incomplete correction. Based on literature, solutions and performance standards are formulated with an emphasis in technology and positive outcome. Despite references to Heart Team decision making, boundary conditions such as hospital infrastructure, caseload, skills training and perioperative risk management remain underexposed. The role of Biomedical Engineering is exclusively defined by the Research and Development (R&D) cycle including the impact of human factor engineering (HFE). Feasibility studies generate estimations of strengths and safety limitations. Usability testing reveals user friendliness and safety margins of clinical use. Apart from a certification requirement, this information should have an impact on the definition of necessary skills levels and consequent required training. Physicians Preference Testing (PPT) and use of a biosimulator are recommended. The example of the interaction between two Amsterdam heart centers describes the evolution of a professional ecosystem that can facilitate innovation. Adaptation to local conditions in terms of infrastructure, referrals and reimbursement, appears essential for the evolution of a complete mitral valve disease management program. Efficacy of institutional risk management performance (IRMP) and sufficient team skills should be embedded in an appropriate infrastructure that enables scale and offers complete and safe solutions for mitral valve disease. The longstanding evolution of mitral valve therapies is the result of working devices embedded in an ecosystem focused on developing skills and effective risk management actions.

Diabetes mellitus in transfemoral transcatheter aortic valve implantation: a propensity matched analysis.

BACKGROUND: Diabetes Mellitus (DM) affects a third of patients with symptomatic severe aortic valve stenosis undergoing transcatheter aortic valve implantation (TAVI). DM is a well-known risk factor for cardiac surgery, but its prognostic impact in TAVI patients remains controversial. This study aimed to evaluate outcomes in diabetic patients undergoing TAVI. METHODS: This multicentre registry includes data of > 12,000 patients undergoing transfemoral TAVI. We assessed baseline patient characteristics and clinical outcomes in patients with DM and without DM. Clinical outcomes were defined by the second valve academic research consortium. Propensity score matching was applied to minimize potential confounding. RESULTS: Of the 11,440 patients included, 31% (n = 3550) had DM and 69% (n = 7890) did not have DM. Diabetic patients were younger but had an overall worse cardiovascular risk profile than non-diabetic patients. All-cause mortality rates were comparable at 30 days (4.5% vs. 4.9%, RR 0.9, 95%CI 0.8-1.1, p = 0.43) and at one year (17.5% vs. 17.4%, RR 1.0, 95%CI 0.9-1.1, p = 0.86) in the unmatched population. Propensity score matching obtained 3281 patient-pairs. Also in the matched population, mortality rates were comparable at 30 days (4.7% vs. 4.3%, RR 1.1, 95%CI 0.9-1.4, p = 0.38) and one year (17.3% vs. 16.2%, RR 1.1, 95%CI 0.9-1.2, p = 0.37). Other clinical outcomes including stroke, major bleeding, myocardial infarction and permanent pacemaker implantation, were comparable between patients with DM and without DM. Insulin treated diabetics (n = 314) showed a trend to higher mortality compared with non-insulin treated diabetics (n = 701, Hazard Ratio 1.5, 95%CI 0.9-2.3, p = 0.08). EuroSCORE II was the most accurate risk score and underestimated 30-day mortality with an observed-expected ratio of 1.15 in DM patients, STS-PROM overestimated actual mortality with a ratio of 0.77 and Logistic EuroSCORE with 0.35. CONCLUSION: DM was not associated with mortality during the first year after TAVI. DM patients undergoing TAVI had low rates of mortality and other adverse clinical outcomes, comparable to non-DM TAVI patients. Our results underscore the safety of TAVI treatment in DM patients. TRIAL REGISTRATION: The study is registered at clinicaltrials.gov (NCT03588247).

Implementation of CT Coronary Angiography as an Alternative to Invasive Coronary Angiography in the Diagnostic Work-Up of Non-Coronary Cardiac Surgery, Cardiomyopathy, Heart Failure and Ventricular Arrhythmias.

To assess the need for additional invasive coronary angiography (CAG) after initial computed tomography coronary angiography (CTCA) in patients awaiting non-coronary cardiac surgery and in patients with cardiomyopathy, heart failure or ventricular arrhythmias, and to determine differences between patients that were referred to initial CTCA or direct CAG, consecutive patients were included between August 2017 and January 2020 and categorized as those referred to initial CTCA (conform protocol), and to direct CAG (non-conform protocol). Out of a total of 415 patients, 78.8% (327 patients, mean age: 57.9 years, 67.3% male) were referred to initial CTCA, of whom 260 patients (79.5%) had no obstructive lesions (<50% DS). A total of 55 patients (16.8%) underwent additional CAG after initial CTCA, which showed coronary lesions of >50% DS in 21 patients (6.3% of 327). Eighty-eight patients (mean age: 66.0 years, 59.1% male) were directly referred to CAG (non-conform protocol). These patients were older and had more cardiovascular risk factors compared to patients that underwent initial CTCA (conform protocol), and coronary lesions of >50% DS were detected in 16 patients (17.2%). Revascularization procedures were infrequently performed in both groups: initial CTCA (3.0%), direct CAG (3.4%). The use of CTCA as a gatekeeper CAG in the diagnostic work-up of non-coronary cardiac surgery, cardiomyopathy, heart failure and ventricular arrhythmias is feasible, and only 17% of these patients required additional CAG after initial CTCA. Therefore, CTCA should be considered as the initial imaging modality to rule out CAD in these patients.

Sex Differences in Transfemoral Transcatheter Aortic Valve Replacement.

BACKGROUND: Transfemoral aortic valve replacement (TAVR) is a guideline-recommended treatment option for patients with severe aortic valve stenosis. Women and men present with different baseline characteristics, which may influence procedural outcomes. OBJECTIVES: This study sought to evaluate differences between women and men undergoing transfemoral TAVR across the globe during the last decade. METHODS: The CENTER (Cerebrovascular EveNts in patients undergoing TranscathetER aortic valve implantation with balloon-expandable valves versus self-expandable valves)-collaboration was a global patient level dataset of patients undergoing transfemoral TAVR (N = 12,381) from 2007 to 2018. In this retrospective analysis, the study examined differences in baseline patient characteristics, 30-day stroke and mortality, and in-hospital outcomes between female and male patients. The study also assessed for temporal changes in outcomes and predictors for mortality per sex. RESULTS: We included 58% (n = 7,120) female and 42% (n = 5,261) male patients. Women had higher prevalence of hypertension and glomerular filtration rate <30 ml/min/1.73 m2 but lower prevalence of all other traditional cardiovascular comorbidities. Both sexes had similar rates of 30-day stroke (2.3% vs. 2.5%; p = 0.53) and mortality (5.9% vs. 5.5%; p = 0.17). In contrast, women had a 50% higher risk of life-threatening or major bleeding (6.7% vs. 4.4%; p < 0.01). Over the study period, mortality rates decreased to a greater extent in men than in women (60% vs. 50% reduction; both p < 0.001), with no reductions in stroke rates over time. CONCLUSIONS: In this global collaboration, women and men had similar rates of 30-day mortality and stroke. However, women had higher rates of procedural life-threatening or major bleeding after TAVR. Between 2007 and 2018, mortality rates decreased to a greater extent in men than in women.

Aortic valve calcification volumes and chronic brain infarctions in patients undergoing transcatheter aortic valve implantation.

Chronic silent brain infarctions, detected as new white matter hyperintensities on magnetic resonance imaging (MRI) following transcatheter aortic valve implantation (TAVI), are associated with long-term cognitive deterioration. This is the first study to investigate to which extent the calcification volume of the native aortic valve (AV) measured with cardiac computed tomography angiography (CTA) predicts the increase in chronic white matter hyperintensity volume after TAVI. A total of 36 patients (79 ± 5 years, median EuroSCORE II 1.9%, Q1-Q3 1.5-3.4%) with severe AV stenosis underwent fluid attenuation inversion recovery (FLAIR) MRI < 24 h prior to TAVI and at 3 months follow-up for assessment of cerebral white matter hyperintensity volume (mL). Calcification volumes (mm3) of the AV, aortic arch, landing zone and left ventricle were measured on the CTA pre-TAVI. The largest calcification volumes were found in the AV (median 692 mm3) and aortic arch (median 633 mm3), with a large variation between patients (Q1-Q3 482-1297 mm3 and 213-1727 mm3, respectively). The white matter hyperintensity volume increased in 72% of the patients. In these patients the median volume increase was of 1.1 mL (Q1-Q3 0.3-4.6 mL), corresponding with a 27% increase from baseline (Q1-Q3 7-104%). The calcification volume in the AV predicted the increase of white matter hyperintensity volume (Δ%), with a 35% increase of white matter hyperintensity volume, per 100 mm3 of AV calcification volume (SE 8.5, p < 0.001). The calcification volumes in the aortic arch, landing zone and left ventricle were not associated with the increase in white matter hyperintensity volume. In 72% of the patients new chronic white matter hyperintensities developed 3 months after TAVI, with a median increase of 27%. A higher calcification volume in the AV was associated with a larger increase in the white matter hyperintensity volume. These findings show the potential for automated AV calcium screening as an imaging biomarker to predict chronic silent brain infarctions.

Two Cases of Endocarditis After MitraClip Procedure Necessitating Surgical Mitral Valve Replacement.

In the present report, we describe 2 cases of endocarditis after MitraClip (Abbott Vascular, Santa Clara, CA) procedures. In both patients, successful bailout surgical treatment was performed despite a high-risk constellation due to significant comorbidities. These cases highlight that surgical treatment may still be an option in patients initially declined for surgical therapy and that endocarditis after MitraClip procedure might be an underrecognized complication.

Impact of mitral valve treatment choice on mortality according to aetiology.

AIMS: Treatment strategies of high-risk patients with mitral regurgitation (MR) differ between disease based on functional and disease based on degenerative origin. In the present study, we aimed to evaluate the effect of surgical, percutaneous, or conservative treatment of MR according to MV mechanism, for high-risk patients. METHODS AND RESULTS: Survival outcomes of MitraClip, surgical, or conservative strategies were compared for 688 high-risk patients with functional MR and 275 with degenerative MR. Cox regression and propensity analyses were used to correct for differences in baseline characteristics. For functional MR, conservative treatment proved to have a higher mortality hazard when compared to MitraClip treatment (hazard ratio [HR] 1.79, 95% confidence interval [CI]: 1.34 to 2.39, p<0.001), while there was no significant difference in mortality hazard between MitraClip and surgery (HR 0.86, 95% CI: 0.54 to 1.38, p=0.541). For degenerative MR, no clear significant benefit was found when comparing MitraClip to conservative and surgical treatment. CONCLUSIONS: High-risk patients with symptomatic functional MR have reduced mortality when undergoing MitraClip intervention, compared to those receiving conservative treatment.

Comparison of balloon-expandable vs. self-expandable valves in patients undergoing transfemoral transcatheter aortic valve implantation: from the CENTER-collaboration.

Aims: The aim of this study was to compare clinical outcomes of patients undergoing transfemoral transcatheter aortic valve implantation (TAVI) with balloon-expandable (BE) valves vs. self-expandable (SE) valves. Transcatheter aortic valve implantation is a minimally invasive and lifesaving treatment in patients with aortic valve stenosis. Even though BE-valves and SE-valves are both commonly used on a large scale, adequately sized trials comparing clinical outcomes in patients with severe aortic valve stenosis treated with BE-valves compared with SE-valves are lacking. Methods and results: In this CENTER-collaboration, data from 10 registries or clinical trials, selected through a systematic search, were pooled and analysed. Propensity score methodology was used to reduce treatment selection bias and potential confounding. The primary endpoints were mortality and stroke at 30 days follow-up in patients treated with BE-valves compared with SE-valves. Secondary endpoints included clinical outcomes, e.g. bleeding during hospital admission. All outcomes were split for early-generation BE-valves compared with early-generation SE-valves and new-generation BE-valves with new-generation SE-valves. The overall patient population (N = 12 381) included 6239 patients undergoing TAVI with BE-valves and 6142 patients with SE-valves. The propensity matched population had a mean age of 81 ± 7 years and a median STS-PROM score or 6.5% [interquartile range (IQR) 4.0-13.0%]. At 30-day follow-up, the mortality rate was not statistically different in patients undergoing TAVI with BE-valves compared with SE-valves [BE: 5.3% vs. SE: 6.2%, relative risk (RR) 0.9; 95% confidence interval (CI) 0.7-1.0, P = 0.10]. Stroke occurred less frequently in patients treated with BE-valves (BE: 1.9% vs. SE: 2.6%, RR 0.7; 95% CI 0.5-1.0, P = 0.03). Also, patients treated with BE-valves had a three-fold lower risk of requiring pacemaker implantation (BE: 7.8% vs. SE: 20.3%, RR 0.4; 95% CI 0.3-0.4, P < 0.001). In contrast, patients treated with new-generation BE-valves more frequently experienced major and life-threatening bleedings compared with new-generation SE-valves (BE: 4.8% vs. SE: 2.1%, RR 2.3; 95% CI 1.6-3.3, P < 0.001). Conclusion: In this study, which is the largest study to compare valve types in TAVI, we demonstrated that the incidence of stroke and pacemaker implantation was lower in patients undergoing transfemoral TAVI with BE-valves compared with SE-valves. In contrast, patients treated with new-generation BE-valves more often suffered from major or life-threatening bleedings than patients with new-generation SE-valves. Mortality at 30-days was not statistically different in patients treated with BE-valves compared with SE-valves. This study was a propensity-matched analysis generated from observational data, accordingly current outcomes will have to be confirmed in a large scale randomized controlled trial.

A computed tomography-based planning tool for predicting difficulty of minimally invasive aortic valve replacement.

OBJECTIVES: Minimally invasive aortic valve replacement has proven its value over the last decade by its significant advancement and reduction in mortality, morbidity and admission time. However, minimally invasive aortic valve replacement is associated with some on-site difficulties such as limited aortic annulus exposure. Currently, computed tomography scans are used to evaluate the anatomical relationship among the intercostal spaces, ascending aorta and aortic valve prior to surgery. We hypothesized that quantitative measurements of access distance and access angle are associated with outcome and access difficulty. METHODS: We introduce a novel minimally invasive aortic valve replacement planning prototype that allows automatic measurements of access angle, access distance and aortic annulus dimensions. The prototype visualizes these measurements on the chest cage as ISO contours. The association of these measures with outcome parameters such as extracorporeal circulation time, aortic cross-clamping time and access difficulty score was assessed. We included 14 patients who received a new valve by ministernotomy. RESULTS: The mean access angle was 40.3 ± 5.1°. It was strongly associated with aortic cross-clamping time (Pearson correlation coefficient = 0.60, P = 0.02) and access difficulty score (Spearman's rank correlation coefficient = 0.57, P = 0.03). Access angles were significantly different between easy and difficult access groups (P = 0.03). There was no significant association between access distance and outcome parameters. CONCLUSIONS: Access angle is strongly associated with procedure complexity. The automated presentation of this measure suggests added value of the prototype in clinical practice.

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

OBJECTIVES: The 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). BACKGROUND: The treatment of ISR remains challenging in contemporary clinical practice. METHODS: In 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. RESULTS: A total of 278 patients, of whom 56% had DES-ISR, were randomized at 8 sites to treatment with DEB (n = 141) or DES (n = 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; p = 0.018; and 26 ± 10% vs. 30 ± 10%; p = 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 6 months, DEB was noninferior to DES (DEB 1.71 ± 0.51 mm vs. DES 1.74 ± 0.61 mm; p for noninferiority <0.0001). Target vessel revascularization at 12-month follow-up was similar in both groups (DES 7.1% vs. DEB 8.8%; p = 0.65). CONCLUSIONS: In 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, use of a DEB is an attractive treatment option for in-stent restenosis, withholding the need for additional stent implantation.

Comparison of Outcome After Percutaneous Mitral Valve Repair With the MitraClip in Patients With Versus Without Atrial Fibrillation.

Percutaneous mitral valve repair with the MitraClip is an established treatment for patients with mitral regurgitation (MR) who are inoperable or at high risk for surgery. Atrial Fibrillation (AF) frequently coincides with MR, but only scarce data of the influence of AF on outcome after MitraClip is available. The aim of the current study was to compare the clinical outcome after MitraClip treatment in patients with versus without atrial fibrillation. Between January 2009 and January 2016, all consecutive patients treated with a MitraClip in 5 Dutch centers were included. Outcome measures were survival, symptoms, MR grade, and stroke incidence. In total, 618 patients were treated with a MitraClip. Patients with AF were older, had higher N-terminal B-type natriuretic peptide levels, more tricuspid regurgitation, less often coronary artery disease and a better left ventricular function. Survival of patients treated with the MitraClip was similar for patients with AF (82%) and without AF (non-AF; 85%) after 1 year (p = 0.30), but significantly different after 5-year follow-up (AF 34%; non-AF 47%; p = 0.006). After 1 month, 64% of the patients with AF were in New York Heart Association class I or II, in contrast to 77% of the patients without AF (p = 0.001). The stroke incidence appeared not to be significantly different (AF 1.8%; non-AF 1.0%; p = 0.40). In conclusion, patients with AF had similar 1-year survival, MR reduction, and stroke incidence compared with non-AF patients. However, MitraClip patients with AF had reduced long-term survival and remained more symptomatic compared with those without AF.

Dynamics of the aortic annulus in 4D CT angiography for transcatheter aortic valve implantation patients.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is a well-established treatment for patients with severe aortic valve stenosis. This procedure requires pre-operative planning by assessment of aortic dimensions on CT Angiography (CTA). It is well-known that the aortic root dimensions vary over the heart cycle. However, sizing is commonly performed at either mid-systole or end-diastole only, which has resulted in an inadequate understanding of its full dynamic behavior. STUDY GOAL: We studied the variation in annulus measurements during the cardiac cycle and determined if this variation is dependent on the amount of calcification at the annulus. METHODS: We measured and compared aortic root annular dimensions and calcium volume in CTA acquisitions at 10 cardiac cycle phases in 51 aortic stenosis patients. Sub-group analysis was performed based on the volume of calcium by splitting the population into mildly and severely calcified valves subgroups. RESULTS: For most annulus measurements, the largest differences were found between 10% and 70 to 80% cardiac cycle phases. Mean difference (±standard deviation) in annular minimum diameter, maximum diameter, area, and aspect ratio between mid-systole and end-diastole phases were 1.0 ± 0.29 mm (p = 0.065), 0.30 ± 0.24 mm (p = 0.7), 24.1 ± 7.6 mm2 (p < 0.001), and 0.041 ± 0.012 (p = 0.039) respectively. Calcium volume measurements varied strongly during the cardiac cycle. The dynamic annulus area was behaving differently between mildly and severely calcified subgroups (p = 0.02). Furthermore, patients with severe aortic calcification were associated with larger annulus diameters. CONCLUSION: There is a significant variation of annulus area and calcium volume measurement during the cardiac cycle. In our measurements, only the dynamic variation of the annulus area is dependent on the severity of the aortic calcification. For TAVI candidates, the annulus area is significantly larger in mid-systole compared to end-diastole.

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.

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.

Long-term ischaemic and bleeding outcomes after primary percutaneous coronary intervention for ST-elevation myocardial infarction in the elderly.

BACKGROUND: The population is ageing rapidly and the proportion of patients aged ≥ 80 years undergoing primary percutaneous coronary intervention (PCI) is rising, but clinical trials have primarily been performed in younger patients. METHODS: Patients undergoing primary PCI between 2003 and 2008 were subdivided into 3 groups: < 60, 60-79, and ≥ 80 years. Endpoints at 3-year follow-up included all-cause mortality, recurrent myocardial infarction (reMI), stent thrombosis, target lesion revascularisation (TLR), bleeding (BARC bleeding ≥ 3), stroke, and major adverse cardiovascular events (MACE, a composite of cardiac mortality, reMI, stroke and TLR). RESULTS: 2002 patients with ST-segment elevation myocardial infarction (STEMI) were included, 885 (44.2 %) aged < 60, 921 (46.0 %) 60-79, and 196 (9.7 %) ≥ 80 years. Comorbidities such as diabetes mellitus, prior stroke, malignant disease, anaemia, and chronic kidney disease were more prevalent in patients ≥ 80 years. The incidence of both ischaemic and bleeding events strongly increased with age. Age ≥ 80 years was an independent predictor of mortality (HR 2.56, 95 % CI1.69-3.87, p < 0.001), a borderline non-significant predictor of overall bleeding (HR 1.38, 95 %CI 0.95-2.00, p = 0.088), and a significant predictor of non-access site bleeding (HR 2.26, 95 %CI 1.46-3.51, p < 0.001). CONCLUSION: Patients ≥ 80 years experienced high rates of ischaemic and bleeding complications; especially in this high-risk patient group individualised therapy is needed to optimise clinical outcomes.

Predictors of outcome in patients undergoing MitraClip implantation: An aid to improve patient selection.

BACKGROUND: MitraClip implantation (MCI) reduces mitral regurgitation (MR) and symptoms in patients considered inoperable or with high-surgical risk. Data to determine the benefit from MCI for an individual patient are limited. The aim of this study is to determine predictors associated with the prognosis after MCI to improve the patient selection for this procedure. METHODS: We included 84 consecutive patients (age: 76 ± 10 years, 51% male) who underwent MCI in our institution for symptomatic severe MR. All patients underwent transthoracic echocardiography before MCI; clinical and echocardiographic follow-up was obtained after MCI. RESULTS: The 2-year survival was 81%. Predictors for two-year mortality in multi-variate analysis were baseline NT-proBNP ≥ 5000 µg/L (HR: 5.4, 95% CI: 1.8-16.2), previous valve surgery (HR: 4.5, 95% CI: 1.7-12.2), tricuspid regurgitation (TR)≥ grade 3 prior to MCI (HR: 2.8, 95% CI: 1.2-6.8) and absence of MR reduction after MCI (HR: 2.1, 95% CI: 1.2-3.8). The 2-year survival of patients with 0, 1 or ≥ 2 of these predictors was: 87%; 78% and 38% respectively (log-rank p < 0.001). The functional class at 1 month and mid-term follow-up was worse in patients with two or more of these predictors present at baseline compared to patients with zero or one of these predictors (1 month: p = 0.007 and mid-term: p < 0.001). CONCLUSION: Heart failure, previous valve surgery, co-presence of TR and the degree of MR reduction after MCI are the independent predictors of survival and functional status after MCI in high risk patients. The pre-procedural characteristics may be used to optimize patient selection, while maximal MR reduction should be attempted to optimize the outcome of MCI.

Initial experience and clinical evaluation of the Absorb bioresorbable vascular scaffold (BVS) in real-world practice: the AMC Single Centre Real World PCI Registry.

AIMS: To report procedural and midterm clinical outcomes after the use of the second-generation Absorb everolimus-eluting bioresorbable vascular scaffold (Absorb BVS) in a real-world percutaneous coronary intervention (PCI) registry. METHODS AND RESULTS: All patients assigned to treatment with the Absorb BVS in the Academic Medical Center, Amsterdam, between August 2012 and August 2013 were included in a prospective registry. A total of 135 patients were included in the study, including 53 (39%) acute coronary syndrome (ACS) patients (13% ST-segment elevation myocardial infarction [STEMI]). In total 159 lesions were treated, including 102 (62%) with a type B2 or C classification. Pre- and post-procedural quantitative coronary angiography (QCA) analyses showed an acute gain of 1.37±0.53 mm. An angiographic success rate was achieved in 152 (96%) of the lesions. Six-month follow-up was available in 97% of the patients. Six-month cumulative target vessel failure (composite of all-cause mortality, any myocardial infarction [MI] and target vessel revascularisation [TVR]) rate was 8.5%, including a 3.0% MI, 3.0% definite scaffold thrombosis, 6.3% target lesion revascularisation, and an 8.5% TVR rate. CONCLUSIONS: The use of the Absorb BVS in a cohort reflecting daily clinical practice is feasible and associated with good procedural safety and angiographic success rate. In addition, six-month follow-up is associated with acceptable clinical outcomes.

Aortic valve calcification as a predictor of location and severity of paravalvular regurgitation after transcatheter aortic valve implantation.

OBJECTIVES: To determine whether the location of aortic valve calcium (AVC) influences the location of paravalvular regurgitation (PR). PR is an adverse effect of transcatheter aortic valve implantation (TAVI) with a negative effect on long-term patient survival. The relationship between AVC and the occurrence of PR has been documented. However, the relationship between the distribution of AVC and the location of PR is still sparsely studied. The purpose of this study was to correlate severity and location of AVC with PR in patients treated with TAVI. METHODS: Fifty-six consecutive patients who underwent transaortic or transapical TAVI and had preoperative computed tomography scans were included in this retrospective study. The volume, mass and location of AVC was determined and compared between patients with and without PR using a non-parametric t-test. Postoperative echocardiography was performed to determine the presence and location of PR, which was associated with the cusp with highest AVC using a χ(2) test. RESULTS: Valve deployment was successful in all 56 patients. PR was present in 38 patients (68%) after TAVI. There was a non-significantly higher volume of AVC in the PR group [214 (70-418) vs 371 (254-606) cm(3), P = 0.15]. AVC mass was significantly higher in patients with PR than in patients without PR [282 (188-421) vs 142 (48-259) mg, respectively, P = 0.043]. The location of PR was determined in 36 of these patients. Of these 36 patients, PR occurred at the cusp with the highest AVC in 20 patients (56%, χ(2) P = 0.030). CONCLUSIONS: In our population, PR was associated with greater AVC mass. Moreover, the location of PR was associated with the cusp with the highest amount of AVC.

[Aortic valve replacement and screening for frailty]. / Aortaklepvervanging en screening op kwetsbaarheid.

The prevalence of aortic stenosis is increasing due to aging of the general population. Transcatheter aortic valve implantation (TAVI) is an alternative for surgical aortic valve replacement (AVR) for high-risk patients. Cardiac scoring systems have been developed to predict the risk of adverse outcomes following surgery, but currently they do not include frailty parameters, and frail patients have an increased risk of adverse health outcomes. Preoperative frailty correlates with adverse outcomes, mortality and functional decline in patients undergoing TAVI; by identifying these patients it is possible to counteract symptoms of frailty by implementing tailored intervention by the geriatrician. The Comprehensive Geriatric Assessment (CGA) is a tool used to detect frailty. Based on the current literature, we highly recommend performing a CGA and a minimum of a Timed Up and Go test, a mini nutritional assessment and serum albumin measurements in patients aged > 70 years undergoing a TAVI or surgical AVR, in order to aim reducing the accompanying risks of the intervention.

Mitral inflow patterns after MitraClip implantation at rest and during exercise.

BACKGROUND: MitraClip implantation reduces mitral regurgitation effectively but decreases mitral valve area, creating iatrogenic mitral stenosis. Evaluation with transesophageal echocardiography intraprocedurally is necessary to measure mitral regurgitation and mitral valve pressure gradient (MVPG) to determine whether it is necessary and safe to place more clips. The aim of this study was to investigate whether these intraprocedural hemodynamics represent postprocedural measurements and whether exercise is affected by the stenosis. METHODS: In this retrospective single-center study, 51 patients who underwent MitraClip implantation were included. Measurements were performed intraprocedurally using transesophageal echocardiography and postprocedurally using transthoracic echocardiography. In 23 of these patients, exercise echocardiography was performed at follow-up. RESULTS: Intraprocedural mean MVPG was 3.0 ± 1.6 mm Hg and increased to 4.3 ± 2.2 mm Hg postprocedurally (P < .001). During exercise, mean MVPG increased significantly compared with rest conditions (from 3.6 ± 1.7 to 6.3 ± 2.7 mm Hg, P < .001). Six patients had mean resting MVPGs ≥ 5 mm Hg at follow-up and had higher systolic pulmonary artery pressure (sPAPs) than patients with mean MVPGs < 5 mm Hg (47 ± 7 vs 35 ± 12 mm Hg, P = .035). Higher MVPG and sPAP did not lead to more symptoms of heart failure. Receiver operating characteristic curve analysis showed an estimated cutoff point for intraprocedural pressure half-time of 91 msec to identify patients with mitral stenosis and sPAP ≥ 50 mm Hg postprocedurally. CONCLUSIONS: Mean MVPG during MitraClip implantation measured by TEE underestimates the hemodynamics in daily life, of which operators should be aware when deciding on placing one or more clips. Pressure half-time seems to be the most robust parameter compared with mean and maximum MVPG and may contribute to this decision. Patients with higher mean MVPGs after MitraClip implantation have higher sPAPs at follow-up. However, more symptoms of heart failure were not detected at follow-up.