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The increasing prevalence of aortic stenosis (AS) and the increasing number of patients indicated for transcatheter aortic valve implantation (TAVI) can lead to increased hospital constraints. This study aimed to compare, from the hospital perspective, the costs, resource use, and 30-day clinical outcomes of patients who underwent TAVI under an optimized or standard clinical pathway. A single-center, retrospective study was conducted among patients with native AS who underwent TAVI between January 2018 and March 2021. Patients who underwent optimized lean TAVI were propensity-score matched 1:1 to those who underwent standard TAVI. In-hospital costs and 30-day clinical outcomes were compared between the 2 groups. A total of 182 patients (91 in each group) were included in the final analysis. Baseline covariates were well balanced after matching. Patients who underwent lean TAVI had shorter length of stay (median [interquartile range] 3.0 days [2.0 to 6.0] vs 6.0 days [5.0 to 9.0], p0.001). Patients in the lean TAVI group incurred lower total costs than did those in the standard TAVI group (mean ± SD: $41,346 ± 10,062 vs $50,471 ± 15,115, p = 0.002). There was no between-group difference in 30-day all-cause mortality (2.2% vs 1.1%, p = 0.573) and pacemaker implantations (5.5% vs 6.6%, p = 0.788). Rates of procedural complications were comparable between groups. In conclusion, lean TAVI leads to hospital efficiencies without compromising patient safety. Efforts to streamline the TAVI procedure should be encouraged to improve access to TAVI for patients with AS, amid resource constraints.

Background The Sentinel cerebral embolic protection device (CEP) aims to reduce the risk of stroke during transcatheter aortic valve replacement (TAVR). We performed a systematic review and meta-analysis of propensity score matched (PSM) and randomized controlled trials (RCT) investigating the effect of the Sentinel CEP to prevent strokes during TAVR. Methods Eligible trials were searched through PubMed, ISI Web of science databases, Cochrane database, and proceedings of major congresses. Primary outcome was stroke. Secondary outcomes included all-cause mortality, major or life-threatening bleeding, major vascular complications and acute kidney injury at discharge. Fixed and random effect models were used to calculate the pooled risk ratio (RR) with 95% confidence intervals (CI) and absolute risk difference (ARD). Results A total of 4066 patients from 4 RCTs (3’506 patients) and 1 PSM study (560 patients) were included. Use of Sentinel CEP was successful in 92% of patients and was associated with a significantly lower risk of stroke (RR: 0.67, 95% CI: 0.48–0.95, p = 0.02. ARD: -1.3%, 95% CI: -2.3 – -0.2, p = 0.02, number needed to treat (NNT) = 77), and a reduced risk of disabling stroke (RR: 0.33, 95% CI: 0.17–0.65. ARD: -0.9%, 95% CI: -1.5 – -0.3, p = 0.004, NNT = 111). Use of Sentinel CEP was associated with a lower risk of major or life-threatening bleeding (RR: 0.37, 95% CI: 0.16–0.87, p = 0.02). Risk for nondisabling stroke (RR: 0.93, 95% CI: 0.62–1.40, p = 0.73), all-cause mortality (RR: 0.70, 95% CI: 0.35–1.40, p = 0.31), major vascular complications (RR: 0.74, 95% CI: 0.33–1.67, p = 0.47) and acute kidney injury (RR: 0.74, 95% CI: 0.37–1.50, p = 0.40) were similar. Conclusions The use of CEP during TAVR was associated with lower risks of any stroke and disabling stroke with an NNT of 77 and 111, respectively.

Patients with severe mitral regurgitation (MR) frequently present with concomitant right ventricular (RV) dysfunction and tricuspid regurgitation (TR). We aimed to investigate the prognostic relevance of RV function, RV dimension, and TR in patients undergoing percutaneous intervention for MR.Consecutive patients undergoing percutaneous mitral valve intervention were enrolled in the prospective MitraSwiss registry. Tricuspid annular plane systolic excursion (TAPSE), pulmonary artery systolic pressure (PASP), right ventricular pulmonary arterial coupling (RVC, defined as TAPSE/ PASP ratio), indexed tricuspid annulus (TA) dimension, and TR severity grade were analyzed at baseline, post procedure, and at 6-month follow-up. The endpoints of all-cause mortality, hospitalization for heart failure, and the combined endpoint of the 2 were observed during long-term follow-up (up to 4 years).We analyzed 218 patients (mean age, 76 ± 9 years; 36% female). Edge-to-edge mitral valve repair resulted in an increase in TAPSE and RVC ratio and a decrease in indexed TA and PASP, but concomitant TR did not change significantly. In multivariable analysis, RV dysfunction and moderate/severe TR were independently associated with increased all-cause mortality (hazard ratio, 1.61; 95% confidence interval, 1.05-2.46; P=.03 and hazard ratio, 2.10; 95% confidence interval, 1.34-3.29; P.01, respectively) and moderate/severe TR was further an independent predictor for hospitalization for heart failure and for the combined endpoint.Treatment of MR resulted in favorable changes of RV function and dimension but did not reduce TR in the majority of patients. TR at baseline remained the strongest predictor for outcomes, outperforming parameters of RV function and dimension.

During the past few years, physicians have optimized transcatheter aortic valve replacement and its periprocedural management, with the minimalist approach becoming popular. We aimed to further simplify the procedure using a single femoral access (the "all-in-one" technique). Here, we report a multicenter experience with TAVR with Acurate neo/neo2 transcatheter heart valves (Boston Scientific) through a single, large-bore, femoral sheath.Patients underwent TAVR with the Acurate neo or neo2 through a single femoral access at 4 centers. The large sheath was used for both the delivery catheter and the pigtail used to visualize the aortic root.A total of 157 patients (59% women) with a mean age of 82 ± 6 years underwent TAVR with the Acurate neo (n = 100) or the Acurate neo2 (n = 57). The procedure was successfully performed through a single large sheath in all patients. Median duration of hospitalization stay was 2 days (interquartile range, 1-3 days). On echocardiography before discharge, the mean gradient was 7 ± 3 mm Hg and 7 patients (4.4%) had more than mild paravalvular leak. At 30 days, a major vascular complication had occurred in 2 patients (1.3%), 2 patients (1.3%) had suffered a stroke, and only 4 patients (2.5%) had required new permanent pacemaker implantation. A total of 3 patients (1.9%) had died.An all-in-one access technique allows safe implantation of Acurate neo and neo2 transcatheter heart valves, with low rates of periprocedural complications and favorable short-term outcomes.

OBJECTIVES We aimed to determine the safety and efficacy of the Allegra transcatheter heart valve (THV) for the treatment of severe aortic valve stenosis in a large patient population treated under real-world conditions. BACKGROUND The Allegra is a novel self-expanding THV with supra-annular bovine leaflets. The valve is available in three different sizes (23, 27, and 31 mm), all are delivered through an 18F sheath. METHODS Consecutive patients undergoing TAVR with the Allegra THV were enrolled in a multicenter-registry. Data were collected throughout initial hospital-stay and at 30-day follow-up. Clinical endpoints were defined according to the updated definitions of the Valve-Academic-Research-Consortium. RESULTS This registry included 255 patients (mean age 83 ± 6 years, 48% women) from four European centers. Median European System for Cardiac Operative Risk Evaluation II score (EuroSCORE II) was 3.3% (IQR 1.9-5.8%). Acute device success was 95.7%. The remaining 11 patients had either moderate paravalvular regurgitation immediately after the procedure (7 patients) or the device could not be optimal positioned requiring implantation of a second THV (4 patients). Major vascular complications and major/life-threatening bleedings occurred in 10 (3.9%) and 12 (4.7%) patients, respectively. At 30 day follow-up, mean effective orifice area was 2.2 ± 0.5 cm2 , mean gradient was 6.9 ± 3.8 mmHg, 7 (3.3%) patients had more than mild paravalvular leakage, 3 patients (1.2%) had died, 6 patients (2.4%) had a stroke and 30 (12.8%) patients had required implantation of a new permanent pacemaker. CONCLUSIONS Transfemoral implantation of the Allegra THV resulted in favorable clinical and echocardiographic outcomes during hospitalization and short-term follow up.

Limus-eluting stents have become the mainstay for percutaneous coronary intervention (PCI). However, even with the latest generation drug-eluting stent, in-stent restenosis and very late stent thrombosis remain a concern. The Selution SLR™ drug-coated balloon (DCB) is a novel sirolimus-coated balloon that provides a controlled release of the antiproliferative drug. Herein is evaluated its performance in a real-world patient cohort with complex coronary artery lesions.Patients undergoing PCI using the Selution SLR™ DCB were analyzed from the prospective SIROOP registry. We evaluated procedural success and clinical outcomes, including major adverse cardiovascular event (MACE), cardiac death, target vessel myocardial infarction and target lesion revascularization.From September 2020 to April 2021, we enrolled 78 patients (87 lesions) treated using a "DCB only" strategy. The mean age was 66.7 ± 10.4 years and 28 (36%) presented with an acute coronary syndrome. Almost all lesions were type B2/C 86 (99%) and 49 (63%) had moderate to severe calcifications. Procedural success was 100%. After a median follow-up of 11.2 months (interquartile range: 10.0-12.6), MACE occurred in 5 (6.8%) patients. No acute vessel closure was observed.In complex coronary lesions, a "DCB only" strategy using the Selution SLR™ DCB is not just safe and feasible, but also seems to be associated with a low rate of MACE at 1-year follow-up. Our promising results warrant further evaluation in a dedicated comparative trial.

Background: Coronary microvascular dysfunction (CMD) is a common cause of angina and exercise intolerance in patients without obstructive coronary artery disease. The efficacy of ranolazine, a late sodium channel blocker, in patients with symptomatic obstructive coronary artery disease is well established. To evaluate the efficacy of ranolazine in CMD, we performed a systematic review and meta-analysis of randomized studies. Methods: MEDLINE, EMBASE, Cochrane CENTRAL, and conference abstracts were searched from January 1975 to March 2020. Randomized trials evaluating ranolazine in patients with CMD were screened. Two reviewers independently extracted data and assessed study quality. End points of interest included a change in angina measured by the Seattle Angina Questionnaire (SAQ), coronary flow reserve (CFR), and clinical outcomes. Data were combined using random-effects models. Results: Of 836 citations, 6 randomized studies (318 patients) were included. Median follow-up was 4 weeks. When pooling the 6 trials analyzing ranolazine, we found that patients treated with ranolazine had a higher SAQ value regarding physical functioning (mean difference, 6.42; 95% confidence interval [CI], 2.41; 10.42) quality of life (10.07; 95% CI, 3.4; 16.74), and angina stability (20.14; 95% CI, 10.12; 30.17), as well as improved CFR (0.27; 95% CI, 0.09; 0.45) compared with placebo/control therapy. A high heterogeneity was observed (range I2, 30%-84%). Conclusions: In CMD, ranolazine may be associated with improvements in CFR and some of the SAQ domains, including angina stability, physical functioning, and quality of life. However, it does not seem to beneficially impact angina frequency and treatment satisfaction. It is also unknown if it improves prognosis of afflicted patients. Résumé: Contexte: La dysfonction microvasculaire coronaire (DMC) est une cause courante d’angine et d’intolérance à l’effort chez les patients sans coronaropathie obstructive. L’efficacité de la ranolazine, un bloqueur des canaux sodiques tardifs, chez les patients atteints d’une coronaropathie obstructive symptomatique est bien établie. Pour évaluer l’efficacité de la ranolazine dans le traitement de la DMC, nous avons effectué une revue systématique et méta-analyse d’études à répartition aléatoire. Méthodologie: MEDLINE, EMBASE, Cochrane CENTRAL et les résumés de congrès ont fait l’objet d’une recherche pour la période allant de janvier 1975 à mars 2020. Les essais à répartition aléatoire sur l’emploi de la ranolazine chez des patients atteints de DMC ont été criblés. Deux examinateurs ont, de manière indépendante, extrait les données et évalué la qualité des études. Les paramètres d’intérêt étaient une variation de l’angine mesurée à l’aide du questionnaire SAQ (Seattle Angina Questionnaire), la réserve coronaire et les issues cliniques. Les données ont été combinées avec des modèles à effets aléatoires. Résultats: Parmi 836 références, six études à répartition aléatoire (318 patients) ont été retenues. La durée médiane de suivi était de quatre semaines. Après avoir regroupé les données des six essais sur la ranolazine, nous avons constaté que les patients traités par la ranolazine avaient un score SAQ plus élevé en ce qui a trait au fonctionnement physique (différence moyenne : 6,42; intervalle de confiance [IC] à 95 % : 2,41 à 10,42), à la qualité de vie (10,07; IC à 95 % : 3,4 à 16,74) et à la stabilité de l’angine (20,14; IC à 95 % : 10,12 à 30,17), de même qu’une réserve coronaire améliorée (0,27; IC à 95 % : 0,09 à 0,45) comparativement aux patients ayant reçu un placebo/traitement témoin. Une forte hétérogénéité a été observée (plage des I2 : 30 à 84 %). Conclusions: Dans les cas de DMC, la ranolazine est associée à des améliorations de la réserve coronaire et de certains des domaines du questionnaire SAQ, dont la stabilité de l’angine, le fonctionnement physique et la qualité de vie. Toutefois, elle ne semble pas avoir d’effet bénéfique sur la fréquence de l’angine et la satisfaction à l’égard du traitement. On ne sait pas non plus si elle améliore le pronostic des patients touchés.

Treatment of in-stent restenosis (ISR) is challenging and treatment failure rate remains high. Correction of stent under-expansion and neointimal compression using the twin-layer OPN™ highly non-compliant balloon (NCB) at high pressure (30 atm) may lead to increased luminal gain and thus better clinical outcomes. We evaluated periprocedural safety and clinical long-term outcomes after ISR treatment using the OPN™ NCB in a real-world population.From an ongoing registry, consecutive ISR patients treated with the OPN™ NCB at a tertiary cardiology center in Switzerland were analyzed. We evaluated procedural efficacy, periprocedural complications, target lesion/vessel failure (TLF/TVF), and major adverse cardiovascular events (MACE).Totally, 208 ISR lesions were treated in 188 patients (mean age 68 ± 13 years, 78 % males). Most lesions were moderately to heavily calcified (89 %), the majority (70.2 %) had complex lesion characteristics (AHA Type B2/C lesions) and 50.5 % were non-focal ISR lesions. After ISR treatment using high pressure pre- and post-dilatation (mean pressure 33 ± 6 atm) with the OPN™ NCB device, the rate of major complications was low (0.96 % coronary perforation, 4 % major dissections, 1.9 % no-reflow and 0.5 % acute vessel closure). At 1-year follow-up, MACE occurred in 19.7 %; 15.4 % patients had TVF; MI and stent thrombosis was found in 5.9 % and 2.1 % of all patients, respectively; and 5 patients died.For ISR treatment, using the super non-compliant OPN™ balloon at very high pressures is safe. Moreover, its use might lead to a low rate of TLF/TVF during long-term follow-up, but this requires further evaluation in dedicated comparative trials.

The ACURATE neo transcatheter heart valve has been associated with very low rates of new conduction disorders (CDs). We assessed the clinical relevance of new CDs in patients undergoing transcatheter aortic valve replacement (TAVR) with this valve. Data of consecutive patients without a pre-existing left bundle branch block (LBBB) or a permanent pacemaker (PPM) undergoing TAVR with the ACURATE neo were analyzed from the prospective SwissTAVI registry. Patients with new CDs were compared with patients with an unchanged electrocardiogram (ECG). ACURATE neo was implanted in 203 patients (mean age 82 ± 6 years, 63% women), CDs occurred in 28 patients (22 [11%] developed a LBBB, 6 [3%] required a PPM). New CDs resulted in a longer median duration of hospitalization (7 vs 5 days, interquartile range 4 to 13 vs 3 to 8 days, p = 0.04). At 1-year follow-up, left ventricular ejection fraction was significantly lower in patients with new CDs comparedwith patients with an unchanged ECG (54% ± 13% vs 61% ± 9%, p0.01). Kaplan-Meier estimates of survival at 1-year were 89% in patients with new CDs and 95% in patients with an unchanged ECG (hazard ratio 2.0, 95% confidence interval 0.7 to 6.2, p = 0.22). After TAVR with the self-expanding ACURATE neo valve, the rate of new CDs, including complete LBBB was low and very few patients required a new PPM. However, new CDs prolonged initial hospitalization and increased the risk for left ventricular-dysfunction at 1-year follow-up. Patients without new CDs had excellent outcomes with a very high survival rate at 1-year follow-up.

Background Myocardial recovery after primary percutaneous coronary intervention in acute myocardial infarction is variable and the extent and severity of injury are difficult to predict. We sought to investigate the role of cardiovascular magnetic resonance T1 mapping in the determination of myocardial injury very early after treatment of ST-segment elevation myocardial infarction (STEMI). Methods STEMI patients underwent 3 T cardiovascular magnetic resonance (CMR), within 3 h of primary percutaneous intervention (PPCI). T1 mapping determined the extent (area-at-risk as %left ventricle, AAR) and severity (average T1 values of AAR) of acute myocardial injury, and related these to late gadolinium enhancement (LGE), and microvascular obstruction (MVO). The characteristics of myocardial injury within 3 h was compared with changes at 24-h to predict final infarct size. Results Forty patients were included in this study. Patients with average T1 values of AAR ≥1400 ms within 3 h of PPCI had larger LGE at 24-h (33% ±14 vs. 18% ±10, P = 0.003) and at 6-months (27% ±9 vs. 12% ±9; P P = 0.016) & [4.0 (0.5–9.5)% vs. 0 (0–3.0)%, P = 0.025]. The average T1 value was an independent predictor of acute LGE (β 0.61, 95%CI 0.13 to 1.09; P = 0.015), extent of MVO (β 0.22, 95%CI 0.03 to 0.41, P = 0.028) and final infarct size (β 0.63, 95%CI 0.21 to 1.05; P = 0.005). Receiver-operating-characteristic analysis showed that T1 value of AAR obtained within 3-h, but not at 24-h, predicted large infarct size (LGE > 9.5%) with 100% positive predictive value at the optimal cut-off of 1400 ms (area-under-the-curve, AUC 0.88, P = 0.006). Conclusion Hyper-acute T1 values of the AAR (within 3 h post PPCI, but not 24 h) predict a larger extent of MVO and infarct size at both 24 h and 6 months follow-up. Delayed CMR scanning for 24 h could not substitute the significant value of hyper-acute average T1 in determining infarct characteristics.

Investigate the impact of concomitant tricuspid regurgitation (TR) on clinical outcomes during long-term follow-up in patients undergoing percutaneous treatment of mitral regurgitation (MR) with the MitraClip system.Patients undergoing mitral repair using the MitraClip frequently present with concomitant TR. It is uncertain how the presence of TR impacts the long-term outcomes of such patients.We analyzed consecutive patients with MitraClip implantation from the prospective MitraSwiss registry. Endpoints were all-cause mortality, hospitalization for heart failure, and the composite endpoint of the two.We enrolled 177 patients (mean age 76 ± 9 years, 37% female). Acute procedural success was achieved in 149 (84%). Concomitant moderate or severe TR was present in 31% at baseline and 32% before discharge. After a median follow-up of 1103 days (IQR: 555-1766 days), 70 (40%) of patients had died, and 34 (19%) were hospitalized for heart failure. In multivariable analysis, TR at baseline was associated with an increase in all-cause mortality (HR: 2.34, 95% CI: 1.36-4.03, p 0.01), hospitalization for heart failure (HR: 3.19, 95% CI: 1.37-7.41, p = 0.01), and the composite endpoint (HR: 2.00, 95% CI: 1.19-3.36, p = 0.01).Despite treatment of MR, TR did not improve in most patients. The presence of relevant TR at baseline was associated with reduced survival and higher rates of hospitalization for heart failure. More research is needed to understand the causal role of TR in such patients and to investigate if simultaneous treatment of concomitant TR may improve prognosis in patients undergoing percutaneous treatment of MR.

Background The percutaneously implanted hemodynamic mechanical support devices Impella are commonly used in patients at risk for or with cardiogenic shock (CS). Impella removal after hemodynamic stabilization on the intensive care unit (ICU) remains a major challenge and is prone to high rates of bleeding and vascular complications. Purpose It is unknown if the use of the novel large-bore access closure device MANTA® is safe and facilitates access management compared to manual compression. Methods Between January 2017 and December 2020, 172 CS patients were treated with an Impella® device at our centre. Of those, in 89 patients the Impella® was removed on the ICU and access site management occurred with either MANTA® device or manual compression. The criteria for MANTA® 14 french device deployment included: (i) femoral artery Diameter >6mm and (ii) absence of significant peripheral arterial disease (PAD). Bleeding and vascular access site complications were assessed and adjudicated according to the Valve Academic Research Consortium-2 (VARC-2) criteria. Results Among the 89 included patients, Impella® removal was performed using the MANTA® device in 31 cases and manual compression in 58 cases. Mean age was 66±11 years, and 50 (56.2%) patients had a CS classified as Society for Cardiovascular Angiography and Interventions (SCAI) D or higher due to myocardial infarction. Median support time was 40 (IQR 24; 69) hours. Baseline characteristics are displayed in Table 1. Immediate haemostasis was more frequently achieved by MANTA® device compared to manual compression (p=0.034). Moreover, we observed significantly less overall (2 (6.5%) vs. 22 (37.9%), p=0.001) and minor bleedings (1 (3.2%) vs. 15 (25.9%), p=0.006) with the MANTA® device when compared to manual compression. Of note, there were no significant differences in vascular complications between the two groups (Table 2). Conclusions In patients requiring Impella® support and residing on ICU, the MANTA® device, compared to standard of care manual compression, seems to be a safe and effective option for access site management, especially with regards to the reduction of bleeding events. However, physicians should carefully assess the vascular anatomy and degree of calcification prior to deployment of the MANTA® device. Nevertheless, more prospective data is necessary for evaluating the optimal access closure among CS patients treated with a percutaneously implanted Impella® device. Funding Acknowledgement Type of funding sources: None. Table 1. Baseline demographicsTable 2. Outcomes

BACKGROUND Optical flow ratio (OFR) is a novel method for fast computation of fractional flow reserve (FFR) from optical coherence tomography (OCT) images. AIMS We aimed to evaluate the accuracy of OFR in predicting post-percutaneous coronary intervention (PCI) FFR and to evaluate the impact of stent expansion on within-stent OFR pressure drop (In-stent OFR). METHODS Post-PCI OFR was computed in patients with both OCT and FFR interrogation immediately after PCI. Calculation of post-PCI OFR (called simulated residual OFR) from pre-PCI OCT pullbacks after elimination of the stenotic segment by virtual stenting was performed in a subgroup of patients who had pre-PCI OCT images. Stent underexpansion was quantified by the minimum expansion index (MEI) of the stented segment. RESULTS A total of 125 paired comparisons between post-PCI OFR and FFR were obtained in 119 patients, among which simulated residual OFR was obtained in 64 vessels. Mean post-PCI FFR was 0.92 ± 0.05. Post-PCI OFR showed good correlation (r = 0.74, p

Objectives This study aimed to compare the value of the index of microcirculatory resistance (IMR) and microvascular obstruction (MVO) measured by cardiac magnetic resonance (CMR) in patients treated for and recovering from ST-segment elevation myocardial infarction. Background IMR can identify patients with microvascular dysfunction acutely after primary percutaneous coronary intervention (pPCI), and a threshold of >40 has been shown to be associated with an adverse clinical outcome. Similarly, MVO is recognized as an adverse feature in patients with ST-segment elevation myocardial infarction. Even though both IMR and MVO reflect coronary microvascular status, the interaction between these 2 parameters is uncertain. Methods A total of 110 patients treated with pPCI were included, and IMR was measured immediately at completion of pPCI. Infarct size (IS) as a percentage of left ventricular mass was quantified at 48 h (38.4 ± 12.0 h) and 6 months (194.0 ± 20.0 days) using CMR. MVO was identified and quantified at 48 h by CMR. Results Overall, a discordance between IMR and MVO was observed in 36.7% of cases, with 31 patients having MVO and IMR ≤40. Compared with patients with MVO and IMR ≤40, patients with both MVO and IMR >40 had an 11.9-fold increased risk of final IS >25% at 6 months (p = 0.001). Patients with MVO and IMR ≤40 had a significantly smaller IS at 6 months (p = 0.001), with significant regression in IS over time (34.4% [interquartile range (IQR): 27.3% to 41.0%] vs. 22.3% [IQR: 16.0% to 30.0%]; p = 0.001). Conclusions Discordant prognostic information was obtained from IMR and MVO in nearly one-third of cases; however, IMR can be helpful in grading the degree and severity of MVO.

OBJECTIVES Report MANTA-associated vascular complications after implementation of key insights on failure mechanisms. BACKGROUND The MANTA vascular closure device is utilized to close large-bore arterial access sites. We have previously identified and published the mechanisms and predictors of MANTA-associated vascular complications. We identified three distinct mechanisms leading to MANTA-associated vascular complications, predictors were a common femoral artery (CFA) diameter

Background: Covered coronary stent (CS) implantation is associated with a high risk for in-stent restenosis (ISR) and stent thrombosis (ST). We describe the outcomes after overstenting (“burying”) CS using contemporary drug-eluting stents (DES). Methods: We analyzed short- and long-term outcomes of consecutive patients who had had a CS implanted, which was consecutively covered (“buried”) with a third-generation DES. CSs were primarily post-dilated and then covered with a longer DES overlapping the proximal and distal edges of the CS. To ensure optimal stent expansion and appositions, all lesions were post-dilated using adequately sized non-compliant balloons. Results: Between 2015 and 2020, 23 patients (mean age 67 ± 14 years, 74% males) were treated using this novel approach. Reasons for implanting CS included treatment of coronary aneurysms (n = 7; 30%), coronary perforations (n = 13; 57%), and aorto-ostial dissections (n = 3; 13%). All CSs were successfully deployed, and no peri-procedural complications occurred. The median time of follow-up was 24.5 (interquartile range [IQR] 11.7–37.9) months. All patients had a 1-month follow-up (FU) and 19/23 (83%) patients had 12-month FU (FU range 1–60 months). No probable or definite STs occurred, and no cardiovascular deaths were observed. Among patients undergoing angiographic FU (11/23 [48%]), 1/23 showed angiographically significant ISR 6 months post CS implantation. Conclusions: Burying a coronary CS under a DES appears to be a safe and promising strategy to overcome the limitations of the currently available CS devices, including a relatively high risk for target lesion failure due to ISR and ST.

© 2021 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License., Aims: Acute pulmonary disorders are known physical triggers of takotsubo syndrome (TTS). This study aimed to investigate prevalence of acute pulmonary triggers in patients with TTS and their impact on outcomes. Methods and results: Patients with TTS were enrolled from the International Takotsubo Registry and screened for triggering factors and comorbidities. Patients were categorized into three groups (acute pulmonary trigger, chronic lung disease, and no lung disease) to compare clinical characteristics and outcomes. Of the 1670 included patients with TTS, 123 (7%) were identified with an acute pulmonary trigger, and 194 (12%) had a known history of chronic lung disease. The incidence of cardiogenic shock was highest in patients with an acute pulmonary trigger compared with those with chronic lung disease or without lung disease (17% vs. 10% vs. 9%, P = 0.017). In-hospital mortality was also higher in patients with an acute pulmonary trigger than in the other two groups, although not significantly (5.7% vs. 1.5% vs. 4.2%, P = 0.13). Survival analysis demonstrated that patients with an acute pulmonary trigger had the worst long-term outcome (P = 0.002). The presence of an acute pulmonary trigger was independently associated with worse long-term mortality (hazard ratio 2.12, 95% confidence interval 1.33-3.38; P = 0.002). Conclusions: The present study demonstrates that TTS is related to acute pulmonary triggers in 7% of all TTS patients, which accounts for 21% of patients with physical triggers. The presence of acute pulmonary trigger is associated with a severe in-hospital course and a worse long-term outcome., C. T. has been supported by the H.H. Sheikh Khalifa binHamad Al-Thani Research Programme and the Swiss HeartFoundation. The InterTAK Registry is supported by the BissDavies Charitable Trust. L. S. M. has been supported by EUHORIZON 2020(SILICOFCM ID777204)

ObjectivesReport predictors and the natural course of paravalvular leak (PVL) following implantation of the ACURATE neo transcatheter heart valve (THV).BackgroundUnderstanding the mechanisms of PVL may help to improve patient selection, patient outcomes and the design of next-generation THVs.MethodsA total of 30 patients (mean age 81±5 years, 47% women) undergoing transcatheter aortic valve replacement with the ACURATE neo were enrolled in the PREDICT PVL study. The effective regurgitant orifice area (EROA, in mm2) of PVL was assessed by transthoracic and transoesophageal echocardiography before discharge and at 6 months follow-up.ResultsPVL was none/trace in 10 (33%), mild in 18 (60%) and moderate in 2 (7%) patients and occurred in distinct locations with largest EROAs in the area of the left coronary cusp and its adjacent commissures. Independent predictors for EROA were implantation depth (r coefficient −1.9 mm2 per mm implantation depth, p=0.01), leaflet calcification (6.2 mm2 per calcification grade, p=0.03) and THV size L (7.6 mm2 more than size S or M, p=0.01). At 6 months follow-up, EROA decreased by 29% from 13.7±9.7 mm2 to 9.5±7.9 mm2 (pConclusionsPVL occurred predominantly in the region of the left coronary cusp and decreased by 29% during 6 months of follow-up. Our results underscore the importance of adequate patient selection and optimal implantation depth.

Background Previous reports have described a leveling off of mortality from premature coronary artery disease (CAD). In recent years, the prevalence of cardiovascular risk factors has increased in rural communities and young adults. Methods and Results We extracted CAD mortality rates from the Centers for Disease Control and Prevention Wide‐Ranging Online Data for Epidemiologic Research (CDC WONDER) database from 1999 to 2017, focusing on mortality from premature CAD (defined as Conclusions Premature CAD mortality rates have declined over time. However, stratification by sex and urbanization reveals disparities that would otherwise remain concealed: CAD mortality rates have increased among women from rural areas since at least 2009.

Objectives This study aimed to investigate the safety and efficacy of ACURATE neo transcatheter aortic valve replacement (TAVR) facilitated by predilatation with the nonocclusive TrueFlow balloon catheter. Background Now that TAVR is moving forward, physicians have attempted to simplify and streamline the procedure and the so-called minimalist approach has become more popular. Methods We enrolled 142 patients (mean age: 82 ± 5 years, 61% female) in a prospective registry. Patients at low risk for intraprocedural third-degree atrioventricular block (AVB) underwent TAVR with the TrueFlow balloon without rapid pacing and without insertion of a provisional pacemaker (n = 121). The remaining 21 patients were predilated with rapid pacing using a provisional pacemaker and a standard balloon. Results Predilatation with the TrueFlow balloon was successful in all 121 patients. Postdilatation was less frequently required after predilatation with the TrueFlow (25% vs. 57%, p = .003). Moreover, median procedural duration with the TrueFlow was significantly shorter (42 [interquartile range, IQR: 34-53] vs. 55 [IQR: 46-61] min, p = .004). In-hospital outcomes were similar. At 30 days, there was no mortality, two (1%) patients had suffered a stroke and only four (3%) had required implantation of a new pacemaker. Conclusion Among patients with a low risk for intraprocedural third-degree AVB, the TrueFlow nonocclusive balloon catheter facilitates implantation of the ACURATE neo without the necessity of rapid pacing and a provisional pacemaker.

IntroductionStent underexpansion is a predictor of in-stent-restenosis and stent thrombosis. Semi-compliant balloons (SCBs) are generally used for lesion preparation. It remains unknown whether routine predilatation using non-compliant balloons (NCBs) improves stent expansion in ordinary coronary lesions.MethodsThe PREdilatation by high-pressure NC balloon catheter for better vessel preparation and Optimal lesion preparation with non-compliant balloons for the implantation of bioresorbable vascular scaffolds studies randomised patients presenting with stable coronary artery disease or non-ST-elevation myocardial infarction requiring stent implantation to lesion preparation using NCBs versus SCBs. Stent expansion index (SEI-minimal luminal area/mean luminal area on optical coherence tomography) and periprocedural complications were compared.ResultsWe enrolled 104 patients: 53 patients (54 lesions) vs 51 patients (56 lesions) to the NCB and SCB groups, respectively. Predilatation pressure was higher in the NCB group (24±7 atmospheres (atm) vs 14±3 atm, pConclusionsIn simple coronary lesions, predilatation/postdilatation with NCBs at high pressures appears to result in better scaffold and stent expansion. Using SCBs only for predilatation might lead to inadequate stent expansion and postdilatation with NCBs might only partially correct this. Predilatation and postdilatation using NCBs at high pressure is safe.Trial registration numberClinicalTrials.gov no. NCT03518645.

Left ventricular (LV) ejection fraction (EF) during high dobutamine stress (HD) by real-time gated-SPECT myocardial perfusion imaging (MPI) on a cadmium-zinc-telluride (CZT) gamma camera was validated versus cardiac magnetic resonance imaging (CMR). After injecting 99mTc-tetrofosmin (320 MBq) in 50 patients (mean age 64 +/− 11 years), EF at rest and post-stress as well as relevant changes in EF at HD (ΔEF ≥ 5%) were assessed. CZT and CMR rest EF values yielded an excellent correlation and agreement (r = 0.96; P < 0.001; Bland–Altman limits of agreement (BA): + 0 to 14.8%). HD EF acquisition was feasible using CZT and correlated better to HD CMR EF than did post-stress CZT EF (r = 0.85 vs 0.76, respectively, all P < 0.001). Agreement in ΔEF detection between HD CMR and immediate post-stress CZT (reflecting standard acquisition using conventional SPECT camera unable to scan during stress) was 45%, while this increased to 85% with real-time HD CZT scan. Real-time ultrafast dobutamine gated-SPECT MPI with a CZT device is feasible and provides accurate measurements of HD LV performance.

BackgroundEarly studies evaluating the performance of bioresorbable scaffold (BRS) Absorb in in-stent restenosis (ISR) lesions indicated promising short-term to mid-term outcomes.AimsTo evaluate long-term outcomes (up to 5 years) of patients with ISR treated with the Absorb BRS.MethodsWe did an observational analysis of long-term outcomes of patients treated for ISR using the Absorb BRS (Abbott Vascular, Santa Clara, California, USA) between 2013 and 2016 at the Heart Centre Luzern. The main outcomes included a device-oriented composite endpoint (DOCE), defined as composite of cardiac death, target vessel (TV) myocardial infarction and TV revascularisation, target lesion revascularisation and scaffold thrombosis (ScT).ResultsOverall, 118 ISR lesions were treated using totally 131 BRS among 89 patients and 31 (35%) presented with an acute coronary syndrome. The median follow-up time was 66.3 (IQR 52.3–77) months. A DOCE had occurred in 17% at 1 year, 27% at 2 years and 40% at 5 years of all patients treated for ISR using Absorb. ScTs were observed in six (8.4%) of the cohort at 5 years.ConclusionsTreatment of ISR using the everolimus-eluting BRS Absorb resulted in high rates of DOCE at 5 years. Interestingly, while event rates were low in the first year, there was a massive increase of DOCE between 1 and 5 years after scaffold implantation. With respect to its complexity, involving also a more unpredictable vascular healing process, current and future BRS should be used very restrictively for the treatment of ISR.

Objectives The index of microcirculatory resistance (IMR) provides a reproducible assessment of the status of coronary microvasculature in patients with ST-elevation myocardial infarction (STEMI). Frequency-domain optical coherence tomography (FD-OCT) enables detailed assessment of the morphology of coronary plaque.We sought to determine the influence of the initial culprit coronary plaque anatomy within the infarct-related artery on IMR after stenting in STEMI. Patients and methods In 25 STEMI patients IMR was measured immediately before and after stent implantation. FD-OCT imaging was performed at the same time points and atherothrombotic volume (ATV) before stenting, prolapsed+floating ATV after stenting and ΔATV was measured using three different strategies. Results There were no relationships between preprocedural IMR and FD-OCT parameters. Prestenting IMR was related only to pain to wire time (P: 0.02). Irrespective of the method adopted, the final IMR was related to prestenting ATV (ρ: 0.44, P: 0.03 for method I, ρ: 0.48, P: 0.02 for method II and ρ: 0.30, P: 0.06 for method III) and ΔATV (ρ: 0.41, P: 0.04 for method II and ρ: 0.44, P: 0.03 for method III). Conclusion IMR measured before stenting is independent of the appearances of the culprit coronary plaque within the infarct-related artery. IMR after stenting, and more importantly, the change in IMR after stenting, reflect the degree of distal embolization during stent implantation.

Objectives We conducted a meta-analysis of studies comparing deferred stenting strategy versus the conventional approach with immediate stenting in patients with ST elevation myocardial infarction. Background Deferring stent after mechanical flow restoration has been proposed as a strategy to reduce the risk of “no reflow” in patients with STEMI undergoing primary percutaneous coronary intervention (pPCI). Conflicting evidence is available currently, especially after the recent publication of three randomized clinical trials. Methods Searches in electronic databases were performed. Comparisons between the two strategies were performed for both hard clinical endpoints (all cause-mortality, cardiovascular mortality, unplanned revascularization, myocardial infarction and readmission for heart failure) and surrogate angiographic endpoints (TIMI flow

Aims We validated a 1-day myocardial perfusion imaging (MPI) protocol using an ultra low-dose(ULD) equal for stress and rest on a cadmium zinc telluride (CZT). Methods and results Fifty-six patients underwent a 1-day MPI protocol using a standard (SD) 99mTc-tetrofosmin dose at stress (320 MBq) and rest (960 MBq) with 5 min acquisition time each (SD). Within 2 weeks MPI was repeated using ULD 99mTc-tetrofosmin equal for stress and rest (160 MBq) with 15 min acquisition time each (ULD). All scans were performed on a CZT camera (DNM 570c, GE Healthcare). Background subtraction was applied on the rest MPI of the ULD using P-mod software. Presence and extent of perfusion defect were analysed. Pearson's correlation was used to compare ejection fraction (EF), end diastolic volume (EDV), and end systolic volume (ESV) between both protocols. SD revealed ischaemia in 23, scar in 3, and an equivocal finding in 1 patient, while normal findings were documented in 29 patients. ULD resulted in the following findings: ischaemia 23, scar 3, and 30 normal scans. Congruence of SD and ULD was 22/23 for ischaemia, 3/3 for scar, and 29/29 in normal patients; one patient with ischaemia in SD was classified as scar in ULD. Overall agreement of ULD with SD was 98%. The mean extent of defect was comparable between SD and ULD for the stress (10% vs. 11%, respectively, P = NS) and rest studies (5% vs. 7%, respectively, P = NS). An excellent correlation between SD and ULD was found for EF (r = 0.93), EDV (r = 0.95), and ESV (r = 0.97). Conclusion CZT cameras may enable reliable MPI scanning in patients with known or suspected coronary artery disease using protocols with about a factor 4-decrease in radiation dose exposure compared with traditional protocols.

Aims: Fractional flow reserve (FFR) can be used to detect a suboptimal result after percutaneous coronary intervention (PCI). A lower post-procedure FFR ( Methods and results: Thirty-five patients undergoing complex PCI were prospectively enrolled. After stenting and post-dilatation, OCT and pressure wire were performed. An FFR threshold Conclusions: Despite a satisfactory angiographic result, a suboptimal functional result is evident in a substantial proportion of patients undergoing complex PCI. Implementation of an OCT-guided PCI optimisation protocol may reveal potentially treatable causes, allowing optimisation of the post-PCI functional result.

Background The quality of the donor heart and the individual risk of the recipient awaiting heart transplantation are difficult to assess. We investigated whether routinely used intensive care scoring systems can provide additional prognostic information on outcomes after heart transplantation. Methods A total of 114 consecutive patients who underwent heart transplantation were included. The Acute Physiology and Chronic Health Evaluation II (APACHE II), the Simplified Acute Physiology Score (SAPS II), and the Sequential Organ Failure Assessment (SOFA) scores were calculated for donors and recipients. Risk factors such as the donor's cause of death, donor's catecholamine use, dialysis status of the recipient, and smoking pattern of the donor and the recipient were assessed. The association of these parameters with mortality, length of stay on the intensive care unit, and need for invasive ventilation was investigated. Results The median APACHE II score of the donors was 20 (confidence interval [CI], 19–20), the median SAPS II score was 46 (CI, 45–48), and the median SOFA score was 10 (CI, 9–10). In contrast, the median scores of the recipients were as follows: APACHE II, 7 (CI, 6–8); SAPS II, 13 (CI, 12–14); and SOFA, 1 (CI, 1–2). None of the scores as calculated significantly predicted clinical outcome after transplantation. Conclusions This study detected no prognostic impact of donor-related risk factors on outcome after heart transplantation. Our findings support the growing practice of also considering organs from donors with high-risk scores for heart transplantation.

OBJECTIVE The study in patients with percutaneous left atrial appendage (LAA) occlusion investigates clinical outcomes according to the position of the Amplatzer Cardiac Plug (ACP) disc. BACKGROUND The ACP consists of a disc and an anchoring lobe. The disc is meant to cover the ostium of the LAA, but frequently retracts partially or completely into the neck of the LAA. It is not known whether a retracted disc affects outcome. METHODS Outcomes of 169 consecutive patients (age 73.1 ± 10.4 years; 76% male) with successful LAA closure were analyzed according to the position of the ACP disc: group A had complete coverage of the LAA ostium; in group B the disc prolapsed partially or completely into the LAA-neck. Transesophageal echocardiography was performed 1-6 months after ACP implantation. The safety endpoint was the composite of clinically significant pericardial effusion, device embolization, procedure-related stroke/transient ischemic attack (TIA), major bleeding, or device thrombus. The efficacy endpoint was the composite of death, neurological events (ischemic and hemorrhagic stroke, TIA), or systemic embolism during follow-up. RESULTS Group A comprised 76 patients (age 73.0 ± 9.9 years; 74% male) and group B 93 patients (age 73.3 ± 10.9 years; 79% male). Mean CHA2 DS2 -Vasc score and HASBLED score were 4.2 ± 1.7 (group A 4.3 ± 1.6; group B 4.2 ± 1.8) and 2.9 ± 1.1 (group A 2.9 ± 1.0; group B 3.0 ± 1.2), respectively. Mean follow-up of the study population was 13.0 ± 10.4 months. Overall, the composite safety and efficacy endpoints occurred in 20 (12%) and 6 patients (4%), respectively. There was no significant difference between groups A and B in the occurrence of the safety endpoint (13% vs. 11%, P = 0.64), or the efficacy endpoint (4% vs. 3%, P = 1.0). CONCLUSIONS No evidence for a difference in the occurrence of the safety and efficacy endpoint was found between patients with complete vs. incomplete ACP disc coverage of the LAA ostium. The risk of repositioning attempts in case of incomplete coverage does not seem to be warranted. Current findings need further confirmation in a larger scale clinical trial.

Purpose: Low yield of invasive coronary angiography and unnecessary coronary interventions have been identified as key cost drivers in cardiology for evaluation of coronary artery disease (CAD). This has fuelled the search for noninvasive techniques providing comprehensive functional and anatomical information on coronary lesions. We have evaluated the impact of implementation of a novel hybrid cadmium-zinc-telluride (CZT)/64-slice CT camera into the daily clinical routine on downstream resource utilization. Methods: Sixty-two patients with known or suspected CAD were referred for same-day single-session hybrid evaluation with CZT myocardial perfusion imaging (MPI) and coronary CT angiography (CCTA). Hybrid MPI/CCTA images from the integrated CZT/CT camera served for decision-making towards conservative versus invasive management. Based on the hybrid images patients were classified into those with and those without matched findings. Matched findings were defined as the combination of MPI defect with a stenosis by CCTA in the coronary artery subtending the respective territory. All patients with normal MPI and CCTA as well as those with isolated MPI or CCTA finding or combined but unmatched findings were categorized as "no match”. Results: All 23 patients with a matched finding underwent invasive coronary angiography and 21 (91%) were revascularized. Of the 39 patients with no match, 5 (13%, p