Safety and efficacy of everolimus-eluting bioresorbable vascular scaffold for cardiac allograft vasculopathy (CART).

BACKGROUND: Cardiac allograft vasculopathy (CAV) is still the main drawback of heart transplantation (HTx) and percutaneous coronary intervention (PCI) is a palliative measure because of the high incidence of failure. OBJECTIVE: This study aimed to investigate the safety and efficacy of bioresorbable scaffolds (BRSs) as potential novel therapeutic tool for the treatment of coronary stenoses in CAV. METHODS: This is a multicenter, single-arm, prospective, open-label study (CART, NCT02377648), that included patients affected by advanced CAV treated with PCI and second-generation ABSORB BRS (Abbott Vascular). The primary endpoint was the incidence of 12-month angiographic in-segment scaffold restenosis (ISSR). Secondary endpoints were the incidence of major adverse cardiac events (MACEs) at 12- and 36-month follow-up and the incidence of ISSR at 36 months. A paired intracoronary imaging analysis at baseline and follow-up was also performed. RESULTS: Between 2015 and 2017 35 HTx patients were enrolled and treated for 44 coronary lesions with 51 BRSs. The primary endpoint occurred in 13.5% of the lesions (5/37), with a cumulative ISSR rate up to 3 years of 16.2% (6/37). Angiographic lumen loss was 0.40 ± 0.62 mm at 12 months and 0.53 ± 0.57 mm at 36 months. Overall survival rate was 91.4% and 74.3%, and MACEs incidence 14.2% and 31.4% at 12 and 36 months, respectively. At the paired intracoronary imaging analysis, a significant increase of the vessel external elastic membrane area in the treated segment and some progression of CAV proximally to the BRS were detected. CONCLUSIONS: BRS-based PCI for the treatment of CAV is feasible and safe, with an ISSR incidence similar to what reported in retrospective studies with drug-eluting stents.

Quantitative aortography for assessment of aortic regurgitation in the era of percutaneous aortic valve replacement.

Paravalvular leak (PVL) is a shortcoming that can erode the clinical benefits of transcatheter valve replacement (TAVR) and therefore a readily applicable method (aortography) to quantitate PVL objectively and accurately in the interventional suite is appealing to all operators. The ratio between the areas of the time-density curves in the aorta and left ventricular outflow tract (LVOT-AR) defines the regurgitation fraction (RF). This technique has been validated in a mock circulation; a single injection in diastole was further tested in porcine and ovine models. In the clinical setting, LVOT-AR was compared with trans-thoracic and trans-oesophageal echocardiography and cardiac magnetic resonance imaging. LVOT-AR > 17% discriminates mild from moderate aortic regurgitation on echocardiography and confers a poor prognosis in multiple registries, and justifies balloon post-dilatation. The LVOT-AR differentiates the individual performances of many old and novel devices and is being used in ongoing randomized trials and registries.

Comparison of different percutaneous revascularisation timing strategies in patients undergoing transcatheter aortic valve implantation.

BACKGROUND: The optimal timing to perform percutaneous coronary interventions (PCI) in transcatheter aortic valve implantation (TAVI) patients remains unknown. AIMS: We sought to compare different PCI timing strategies in TAVI patients. METHODS: The REVASC-TAVI registry is an international registry including patients undergoing TAVI with significant, stable coronary artery disease (CAD) at preprocedural workup. In this analysis, patients scheduled to undergo PCI before, after or concomitantly with TAVI were included. The main endpoints were all-cause death and a composite of all-cause death, stroke, myocardial infarction (MI) or rehospitalisation for congestive heart failure (CHF) at 2 years. Outcomes were adjusted using the inverse probability treatment weighting (IPTW) method. RESULTS: A total of 1,603 patients were included. PCI was performed before, after or concomitantly with TAVI in 65.6% (n=1,052), 9.8% (n=157) or 24.6% (n=394), respectively. At 2 years, all-cause death was significantly lower in patients undergoing PCI after TAVI as compared with PCI before or concomitantly with TAVI (6.8% vs 20.1% vs 20.6%; p<0.001). Likewise, the composite endpoint was significantly lower in patients undergoing PCI after TAVI as compared with PCI before or concomitantly with TAVI (17.4% vs 30.4% vs 30.0%; p=0.003). Results were confirmed at landmark analyses considering events from 0 to 30 days and from 31 to 720 days. CONCLUSIONS: In patients with severe aortic stenosis and stable coronary artery disease scheduled for TAVI, performance of PCI after TAVI seems to be associated with improved 2-year clinical outcomes compared with other revascularisation timing strategies. These results need to be confirmed in randomised clinical trials.

Clinical outcomes in women and men with small aortic annuli undergoing transcatheter aortic valve implantation: A multicenter, retrospective, propensity score-matched comparison.

BACKGROUND: Sex-specific characteristics in patients with aortic stenosis and small annuli undergoing transcatheter aortic valve implantation (TAVI) might affect clinical outcomes and hemodynamics. METHODS: TAVI-SMALL 2 international retrospective registry included 1378 patients with severe aortic stenosis and small annuli (annular perimeter <72 mm or area < 400 mm2) treated with transfemoral TAVI at 16 high-volume centers between 2011 and 2020. Women (n = 1233) were compared with men (n = 145). One-to-one propensity score (PS) matching resulted in 99 pairs. Primary endpoint was incidence of all-cause mortality. Incidence of pre-discharge severe prosthesis-patient mismatch (PPM) and its association with all-cause mortality were investigated. Binary logistic and Cox regression were performed to adjust the treatment effect for PS quintiles. RESULTS: Incidence of all-cause mortality at a median follow-up of 377 days did not differ between sex in the overall (10.3 vs. 9.8%, p = 0.842) and PS-matched (8.5 vs. 10.9%, p = 0.586) populations. After PS matching, pre-discharge severe PPM was numerically higher in women vs. men (10.2 vs. 4.3%), even though no evidence of a difference was found (p = 0.275). Within the overall population, women with severe PPM suffered a higher incidence of all-cause mortality when compared to those with less than moderate PPM (log-rank p = 0.024) and less than severe PPM (p = 0.027). CONCLUSIONS: No difference in all-cause mortality at medium-term follow-up was observed between women and men with aortic stenosis and small annuli undergoing TAVI. Incidence of pre-discharge severe PPM was numerically higher in women than men, and it was associated with increased all-cause mortality in women.

Implantation of contemporary transcatheter aortic valves in small aortic annuli: the international multicentre TAVI-SMALL 2 registry.

BACKGROUND: Treatment of aortic stenosis in patients with small annuli is challenging and can result in prosthesis-patient mismatch (PPM). AIMS: We aimed to compare the forward flow haemodynamics and clinical outcomes of contemporary transcatheter valves in patients with small annuli. METHODS: The TAVI-SMALL 2 international retrospective registry included 1,378 patients with severe aortic stenosis and small annuli (annular perimeter <72 mm or area <400 mm2) treated with transfemoral self-expanding (SEV; n=1,092) and balloon-expandable valves (BEV; n=286) in 16 high-volume centres between 2011 and 2020. Analyses comparing SEV versus BEV and supra-annular (SAV; n=920) versus intra-annular valves (IAV; n=458) included inverse probability of treatment weighting (IPTW). The primary endpoints were the predischarge mean aortic gradient and incidence of severe PPM. The secondary endpoint was the incidence of more than mild paravalvular leak (PVL). RESULTS: The predischarge mean aortic gradient was lower after SAV versus IAV (7.8±3.9 vs 12.0±5.1; p<0.001) and SEV versus BEV implantation (8.0±4.1 vs 13.6±4.7; p<0.001). Severe PPM was more common with IAV and BEV when compared to SAV and SEV implantation, respectively, (8.8% vs 3.6%; p=0.007 and 8.7% vs 4.6%; p=0.041). At multivariable logistic regression weighted by IPTW, SAV protected from severe PPM regardless of its definition. More than mild PVL occurred more often with SEV versus BEV (11.6% vs 2.6%; p<0.001). CONCLUSIONS: In small aortic annuli, implantation of SAV and SEV was associated with a more favourable forward haemodynamic profile than after IAV and BEV implantation, respectively. More than mild PVL was more common after SEV than BEV implantation.

Prediction of mortality and heart failure hospitalisations in patients undergoing M-TEER: external validation of the COAPT risk score.

BACKGROUND: A risk score was recently derived from the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) Trial. However, external validation of this score is still lacking. AIMS: We aimed to validate the COAPT risk score in a large multicentre population undergoing mitral transcatheter edge-to-edge repair (M-TEER) for secondary mitral regurgitation (SMR). METHODS: The Italian Society of Interventional Cardiology (GIse) Registry of Transcatheter Treatment of Mitral Valve RegurgitaTiOn (GIOTTO) population was stratified according to COAPT score quartiles. The performance of the COAPT score for 2-year all-cause death or heart failure (HF) hospitalisation was evaluated in the overall population and in patients with or without a COAPT-like profile. RESULTS: Among the 1,659 patients included in the GIOTTO registry, 934 had SMR and complete data for a COAPT risk score calculation. The incidence of 2-year all-cause death or HF hospitalisation progressively increased through the COAPT score quartiles in the overall population (26.4% vs 44.5% vs 49.4% vs 59.7%; log-rank p<0.001) and COAPT-like patients (24.7% vs 32.4% vs 52.3% vs. 53.4%; log-rank p=0.004), but not in those with a non-COAPT-like profile. The COAPT risk score had poor discrimination and good calibration in the overall population, moderate discrimination and good calibration in COAPT-like patients and very poor discrimination and poor calibration in non-COAPT-like patients. CONCLUSIONS: The COAPT risk score has a poor performance in the prognostic stratification of real-world patients undergoing M-TEER. However, after application to patients with a COAPT-like profile, moderate discrimination and good calibration were observed.

Proof of concept study on coronary microvascular function in low flow low gradient aortic stenosis.

OBJECTIVES: We hypothesised that low flow low gradient aortic stenosis (LFLGAS) is associated with more severe coronary microvascular dysfunction (CMD) compared with normal-flow high-gradient aortic stenosis (NFHGAS) and that CMD is related to reduced cardiac performance. METHODS: Invasive CMD assessment was performed in 41 consecutive patients with isolated severe aortic stenosis with unobstructed coronary arteries undergoing transcatheter aortic valve implantation (TAVI). The index of microcirculatory resistance (IMR), resistive reserve ratio (RRR) and coronary flow reserve (CFR) were measured in the left anterior descending artery before and after TAVI. Speckle tracking echocardiography was performed to assess cardiac function at baseline and repeated at 6 months. RESULTS: IMR was significantly higher in patients with LFLGAS compared with patients with NFHGAS (24.1 (14.6 to 39.1) vs 12.8 (8.6 to 19.2), p=0.002), while RRR was significantly lower (1.4 (1.1 to 2.1) vs 2.6 (1.5 to 3.3), p=0.020). No significant differences were observed in CFR between the two groups. High IMR was associated with low stroke volume index, low cardiac output and reduced peak atrial longitudinal strain (PALS). TAVI determined no significant variation in microvascular function (IMR: 16.0 (10.4 to 26.1) vs 16.6 (10.2 to 25.6), p=0.403) and in PALS (15.9 (9.9 to 26.5) vs 20.1 (12.3 to 26.7), p=0.222). Conversely, left ventricular (LV) global longitudinal strain increased after TAVI (-13.2 (8.4 to 16.6) vs -15.1 (9.4 to 17.8), p=0.047). In LFLGAS, LV systolic function recovered after TAVI in patients with preserved microvascular function but not in patients with CMD. CONCLUSIONS: CMD is more severe in patients with LFLGAS compared with NFHGAS and is associated with low-flow state, left atrial dysfunction and reduced cardiac performance.

Angiography-derived index of microvascular resistance in takotsubo syndrome.

Coronary microvascular dysfunction (CMD) has been proposed as a key driver in the etiopathogenesis of Takotsubo syndrome (TTS), likely related to an "adrenergic storm" upon a susceptible microvascular circulation. The aim of our manuscript was to assess CMD in patients with TTS through the computation of the angiography-derived index of microcirculatory resistance (IMR) and its correlation with clinical presentation. Coronary angiograms of 41 consecutive TTS patients were retrospectively analyzed to derive angiography-based indices of CMD. Three indices (NH-IMRangio, AngioIMR and A-IMR) were calculated based on quantitative flow ratio. CMD was defined as an IMRangio value ≥ 25 units. The correlation between CMD and clinical presentation was then assessed. Median age was 76 years, 85.7% were women and mean left ventricular ejection fraction (LVEF) at first echocardiogram was 41.2%. Angiography-derived IMR was higher in left anterior descending artery (LAD) than circumflex and right coronary artery with either NH-IMRangio (53.9 ± 19.8 vs 35.8 ± 15.4 vs 40.8 ± 18.5, p-value < 0.001), AngioIMR (47.2 ± 17.3 vs 31.8 ± 12.2 vs 37.3 ± 13.7, p-value < 0.001) or A-IMR (52.7 ± 19 vs 36.1 ± 14.1 vs 41.8 ± 16.1, p-value < 0.001). All patients presented CMD with angiography-derived IMR ≥ 25 in at least one territory with each formula. Angiography-derived IMR in LAD territory was significantly higher in patients presenting with LVEF impairment (≤ 40%) than in those with preserved ventricular global function (NH-IMRangio: 59.3 ± 18.1 vs 46.3 ± 16.0 p-value = 0.030; AngioIMR: 52.9 ± 17.8 vs 41.4 ± 14.2, p-value = 0.037; A-IMR: 59.2 ± 18.6 vs 46.3 ± 17.0, p-value = 0.035). CMD assessed with angiography-derived IMR is a common finding in TTS and it is inversely correlated with LV function. The available formulas have a substantial superimposable diagnostic performance in assessing coronary microvascular function.

Management of Myocardial Revascularization in Patients With Stable Coronary Artery Disease Undergoing Transcatheter Aortic Valve Implantation.

BACKGROUND: The best management of stable coronary artery disease (CAD) in patients undergoing transcatheter aortic valve implantation (TAVI) is still unclear due to the marked inconsistency of the available evidence. METHODS: The REVASC-TAVI registry (Management of Myocardial Revascularization in Patients Undergoing Transcatheter Aortic Valve Implantation With Coronary Artery Disease) collected data from 30 centers worldwide on patients undergoing TAVI who had significant, stable CAD at preprocedural work-up. For the purposes of this analysis, patients with either complete or incomplete myocardial revascularization were compared in a propensity score matched analysis, to take into account of baseline confounders. The primary and co-primary outcomes were all-cause death and the composite of all-cause death, stroke, myocardial infarction, and rehospitalization for heart failure, respectively, at 2 years. RESULTS: Among 2407 patients enrolled, 675 pairs of patients achieving complete or incomplete myocardial revascularization were matched. The primary (21.6% versus 18.2%, hazard ratio' 0.88 [95% CI, 0.66-1.18]; P=0.38) and co-primary composite (29.0% versus 27.1%, hazard ratio' 0.97 [95% CI, 0.76-1.24]; P=0.83) outcome did not differ between patients achieving complete or incomplete myocardial revascularization, respectively. These results were consistent across different prespecified subgroups of patients (< or >75 years of age, Society of Thoracic Surgeons score > or <4%, angina at baseline, diabetes, left ventricular ejection fraction > or <40%, New York Heart Association class I/II or III/IV, renal failure, proximal CAD, multivessel CAD, and left main/proximal anterior descending artery CAD; all P values for interaction >0.10). CONCLUSIONS: The present analysis of the REVASC-TAVI registry showed that, among TAVI patients with significant stable CAD found during the TAVI work-up, completeness of myocardial revascularization achieved either staged or concomitantly with TAVI was similar to a strategy of incomplete revascularization in reducing the risk of all cause death, as well as the risk of death, stroke, myocardial infarction, and rehospitalization for heart failure at 2 years, regardless of the clinical and anatomical situations.

Functional Patterns of Coronary Disease: Diffuse, Focal, and Serial Lesions.

The physiological assessment of coronary lesions is influenced by the pattern and distribution of coronary artery disease (CAD), including focal lesions, serial lesions, diffuse disease, and mixed patterns. These various patterns of CAD impact the accuracy of pressure wire and angiography-derived physiology indexes, and diffuse disease in particular is an important determinant of the anticipated outcome of percutaneous coronary intervention. Therefore, identification of the physiological pattern of disease provides relevant information for the management of CAD and percutaneous coronary intervention procedural planning. At present, the classification of physiological patterns and its implications for the tailored management of a patient with CAD are poorly defined. This state-of-the-art review provides an overview of the available evidence on functional patterns of CAD with a special focus on their diagnostic and therapeutic implications. It also aims to provide clear definitions of physiological patterns of CAD based on the available evidence and expert opinion. A practical algorithm is provided to optimize the use of pressure wire and angiography-derived indexes of coronary physiology in the settings of focal, serial, and diffuse lesions, with the addition of intracoronary imaging in selected cases.

Predictors and Prognostic Impact of Left Ventricular Ejection Fraction Recovery after Impella-Supported Percutaneous Coronary Interventions in Acute Myocardial Infarction.

Aim: The aim of our study is to assess the predictors and the prognostic role of left ventricle ejection fraction (LVEF) recovery after Impella-supported percutaneous coronary intervention (PCI) in patients presenting with acute myocardial infarction (AMI). Methods: This retrospective, observational study included patients admitted for AMI who underwent Impella-supported PCI in two Italian high-volume cardiac catheterization laboratories. Only patients who underwent an echocardiographic assessment of left ventricle ejection fraction (LVEF) before the procedure (acute LVEF) and during follow-up (follow-up LVEF) were included in the present analysis. Patients with a baseline LVEF ≥40% were excluded from the present analysis. LVEF recovery was calculated as the difference between follow-up LVEF and acute LVEF. A delta ≥5% was considered significant and was used to define the responder group. Results: From April 2007 to December 2020, 64 consecutive patients were included in our study. A total of 55 patients (86%) received hemodynamic support with Impella 2.5, and 9 patients (14%) with Impella CP. Median LVEF at follow-up was significantly higher compared to baseline (36% (30−42) vs. 30% (24−33), p < 0.001). Based on LVEF recovery, 37 patients (57.8%) were deemed responders. According to multivariate analysis, complete functional revascularization was an independent predictor of a significant EF recovery (OR: 0.159; 95% CI: 0.038−0.668; p = 0.012). At three-year follow-up, lack of LVEF recovery was the only predictor of mortality (HR: 5.315; 95% CI: 1.100−25.676; p = 0.038). Conclusions: Functional complete revascularization is an independent predictor of the recovery of LVEF in patients presenting with AMI who underwent Impella-supported PCI. The recovery of LV function is associated with improved prognosis and could be used to stratify the risk of future events at long-term follow-up.

Comparative Prognostic Value of Parameters of Pulsatile Right Ventricular Afterload in Patients With Advanced Heart Failure Awaiting Heart Transplantation.

Right ventricular pulsatile afterload (RVPA) demonstrated a strong impact on survival of patients with advanced heart failure (HF) with reduced ejection fraction. The best prognostic parameter of RVPA is unknown. The aim of this work was to examine the prognostic relevance of pulmonary artery compliance (PAC), pulmonary artery elastance (PAE), and pulmonary artery pulsatile index (PAPi) in a consecutive cohort of patients with advanced HF evaluated for heart transplantation (HT). A total of 149 patients with end-stage HF underwent right-sided cardiac catheterization and were clinically followed up until death or any censoring events, including HT, left ventricular assist device, and hospitalization for acute HF. The primary endpoint occurred in 29 patients (19.5%) during a median follow-up time of 12 (interquartile range 3 to 34) months. This cohort presented a worse hemodynamic profile than event-free survivors. PAC <1.9 mL/mm Hg (hazard ratio 3, 95% confidence interval 1.3 to 6.0, p= 0.007) and PAE >0.9 mmHg/mL (hazard ratio 2.5, 95% confidence interval 1.1 to 5.2, p= 0.02) were associated with the adverse outcome. On the contrary, PAPi was not associated with the outcome. PAC demonstrated a superior predictive value for the composite adverse outcome compared with pulmonary vascular resistance (area under the curve comparison p= 0.019) and PAPi (p= 0.03) but similar compared with PAE (p= 0.19) and mean pulmonary arterial pressure (p= 0.51). PAC, but not PAE, showed incremental prognostic value compared with cardiac index (p= 0.02). In conclusion, hemodynamic indexes of RVPA are associated with worse survival in patients with end-stage HF. PAC and PAE demonstrated superior prognostic value compared with PAPi and pulmonary vascular resistance. Moreover, PAC showed incremental prognostic value compared with cardiac index in patients awaiting HT.

The Ongoing Saga of the Evolution of Percutaneous Coronary Intervention: From Balloon Angioplasty to Recent Innovations to Future Prospects.

The advances in percutaneous coronary intervention (PCI) have been, above all, dependent on the work of pioneers in surgery, radiology, and interventional cardiology. From Grüntzig's first balloon angioplasty, PCI has expanded through technology development, improved protocols, and dissemination of best-practice techniques. We can nowadays treat more complex lesions in higher-risk patients with favourable results. Guide wires, balloon types and profiles, debulking techniques such as atherectomy or lithotripsy, stents, and scaffolds all represent evolutions that have allowed us to tackle complex lesions such as an unprotected left main coronary artery, complex bifurcations, or chronic total occlusions. Best-practice PCI, including physiology assessment, imaging, and optimal lesion preparation are now the gold standard when performing PCI for sound indications, and new technologies such as intravascular lithotripsy for lesion preparation, or artificial intelligence, are innovations in the steps of 4 decades of pioneers to improve patient care in interventional cardiology. In the present review, major innovations in PCI since the first balloon angioplasty and also uncertainties and obstacles inherent to such medical advances are described.

Optimal timing for percutaneous coronary intervention in patients undergoing transcatheter aortic valve implantation.

BACKGROUND: The best timing to perform percutaneous coronary interventions (PCI) in patients undergoing TAVI is unknown. Most PCI are performed before TAVI, because of concerns about potential ischemic complications during valve implantation. In this study we aimed to compare short-and long-term outcomes of patients undergoing PCI before or after TAVI. METHODS: Patients undergoing TAVI and PCI from 2010 to 2021 were analyzed. PCI was defined as high-risk when involving unprotected left main, proximal left anterior descending, proximal dominant right coronary artery or 3-vessel disease. The primary endpoint was the cumulative incidence of any TAVI procedural complication and in-hospital adverse events (VARC-3 criteria). RESULTS: Out of 1162 patients, 144 underwent PCI, 68% after TAVI, 78.4% of which were at high-risk. The primary endpoint occurred in 28.4% of patients in PCI pre-TAVI group vs 21.4% in PCI post-TAVI group (p = 0.403) and in 34.4% vs 17.3% of patients respectively among high-risk patients (p = 0.075). A higher rate of stroke was observed in the PCI pre-TAVI group regardless of the PCI complexity (6.5% vs 0.0%, p = 0.031; 9.3% vs 0.0% p = 0.025 in the high-risk group). At 24 months, MACCE-free survival was lower in patients who underwent PCI before TAVI (84.4% vs 97.9%, adjusted HR 10.16, 95% CI 1.19-86.57, p = 0.019; and 84.4% vs 97.3%, adjusted HR 7.34 95% CI 0.78-62.28 p = 0.082 in the high-risk group). CONCLUSIONS: PCI performed after TAVI does not expose patients to higher risks of peri-procedural hazards and provides a trend towards favourable clinical outcome at mid-to-long term.

Edge-to-edge percutaneous mitral repair for functional ischaemic and non-ischaemic mitral regurgitation: a systematic review and meta-analysis.

AIM: Randomized controlled trials comparing the use of the MitraClip device in addition to guideline directed medical therapy (GDMT) to GDMT alone in patients with secondary mitral regurgitation (MR) have shown conflicting results. However, if these differences could be due to the underlying MR aetiology is still unknown. Therefore, we aimed to evaluate if the effects of percutaneous edge-to-edge repair with MitraClip implantation could differ in patients with ischaemic (I-MR) and non-ischaemic mitral regurgitation (NI-MR). METHODS AND RESULTS: PubMed, Embase, BioMed Central, and the Cochrane Central Register of Controlled Trials were searched for all studies including patients with secondary MR treated with the MitraClip device. Data were pooled using a random-effects model. Primary endpoint was the composite of all-cause death and heart failure-related hospitalization. Secondary endpoints were the single components of the primary endpoint, New York Heart Association functional Classes III and IV, and mitral valve re-intervention. Seven studies enrolling 2501 patients were included. Patients with I-MR compared with patients with NI-MR had a similar risk of the primary endpoint (odds ratio: 1.17; 95% confidence interval: 0.93 to 1.46; I2 : 0%). The risk of all-cause death was increased in patients with I-MR (odds ratio: 1.31; 95% confidence interval: 1.07 to 1.62; I2 : 0%), while no differences were observed between the two groups in terms of the other secondary endpoints. CONCLUSIONS: The risk of mortality after MitraClip implantation is lower in patients with NI-MR than in those with I-MR. No absolute differences in the risk of heart failure related hospitalization were observed between groups.

Volume of contrast to creatinine clearance ratio predicts early mortality and AKI after TAVI.

The volume of contrast to creatinine clearance ratio (CV/CrCl) is a useful indicator of the risk of acute kidney injury (AKI) in patients undergoing percutaneous interventional procedures. Association between CV/CrCl and adverse outcome after transcatheter aortic valve implantation (TAVI) was suggested but it is not well established. A large retrospective multicenter cohort of 1381 patients treated with TAVI was analyzed to assess the association between CV/CrCl and the risk of AKI and mortality at 90 days and 1 year after TAVI. Patients receiving renal replacement therapy at the time of TAVI were excluded. CV/CrCl ≥ 2.2 was associated with the risk of AKI and 90 days mortality after TAVI after adjustment for age, sex, diabetes, baseline left ventricular function, baseline chronic kidney disease (CKD), previous myocardial infarction and peripheral vascular disease (hazard ratio [HR]: 1.16, 95% confidence interval [CI]: 1.09-1.22, p < 0.0001). Importantly, CV/CrCl was associated with the adverse outcome independently from the presence of baseline CKD (p for interaction = 0.22). CV/CrCl was independently associated with the individual components of the composite primary outcome including AKI (odds ratio: 1.18, 95% CI: 1.08-1.28, p < 0.0001) and 90 days mortality (HR: 1.90, 95% CI: 1.01-3.60, p = 0.047) after TAVI. AKI (HR: 1.94, 95% CI: 1.21-3.11, p = 0.006) but not CV/CrCl was associated with the risk of 1-year mortality after TAVI. CV/CrCl is associated with excess renal damage and early mortality after TAVI. Procedural strategies to minimize the CV/CrCl during TAVI may improve early clinical outcomes in patients undergoing TAVI.

Incomplete Functional Revascularization Is Associated With Adverse Clinical Outcomes After Transcatheter Aortic Valve Implantation.

BACKGROUND AND PURPOSE: Whether incomplete functional revascularization has an impact on the clinical outcome of patients treated with transcatheter aortic valve implantation (TAVI) is still unknown. We aim to assess the prognostic value of residual functional SYNTAX score (rFSS) in a cohort of patients undergoing TAVI. METHODS AND RESULTS: One-hundred-twenty-four patients (229 lesions) with severe aortic stenosis and coronary artery disease (CAD) underwent fractional flow reserve (FFR)-guided revascularization. The primary endpoint of the study was the composite of cardiac death, myocardial infarction, and revascularization at the last available follow-up after TAVI. Median SYNTAX score (SS) and Functional SYNTAX score (FSS) at baseline were 7 (range 5-12) and 0 (range 0-7) respectively. After revascularization or deferral according to FFR, residual SS (rSS) and rFSS were 5 (range 0-8) and 0 (range 0-0) respectively. Angiographic incomplete revascularization (rSS > 0) was not associated with the primary endpoint (HR 1.2; 95% CI 0.4-3.9; p = 0.69), whereas functional incomplete revascularization (rFSS>0) was associated with worse event-free survival at follow up after adjusting for clinical confounders (HR 3.7; 95% CI 1.0-13.7; p = 0.04). CONCLUSION: Incomplete functional revascularization is associated with adverse clinical outcomes after TAVI. Residual functional SYNTAX score may be regarded as a treatment goal for patients with CAD undergoing TAVI. Further studies are warranted to confirm our hypothesis.

Vascular complications after transcatheter aortic valve implantation: treatment modalities and long-term clinical impact.

OBJECTIVES: Vascular complications (VC) are the most frequent drawback of transcatheter aortic valve implantation (TAVI), affecting up to 20% of overall procedures. Data on the treatment and their long-term impact are scarce. The goal of this study was to report on the incidence, management and impact on the long-term outcomes of VC following TAVI. METHODS: This was a multicentric retrospective analysis of consecutive patients undergoing TAVI. The primary endpoint was freedom from major adverse cardiac and cerebrovascular events at long-term follow-up. Adverse events were evaluated according to Valve Academic Research Consortium-2 criteria. RESULTS: A total of 2145 patients were included: VC occurred in 188 (8.8%); of which 180 were limited to the access site. Two-thirds of the VC were minor; 8% required surgical treatment; the remaining were repaired percutaneously. The major adverse cardiac and cerebrovascular events-free survival at 2 years was 83.0% for patients with VC and 86.7% for those without (P = 0.143), but 71.9% for patients with major compared to 89.0% in those with minor VC (P = 0.022). Major VC and diabetes mellitus independently predicted worse outcomes at 2 years. The major adverse cardiac and cerebrovascular events-free survival rate and the occurrence of vascular adverse events in the long term among patients with VC at the access site treated by endovascular techniques (covered stent implantation or angioplasty) were similar to those without VC (84.2% vs 86.7%; P = 0.635). CONCLUSIONS: Major but not minor VC impact long-term survival after TAVI. Covered stents implanted to manage VC at the access site have no impact on the long-term clinical outcome of TAVI.