Aspirin with or without Clopidogrel after Transcatheter Aortic-Valve Implantation.

BACKGROUND: The effect of single as compared with dual antiplatelet treatment on bleeding and thromboembolic events after transcatheter aortic-valve implantation (TAVI) in patients who do not have an indication for long-term anticoagulation has not been well studied. METHODS: In a randomized, controlled trial, we assigned a subgroup of patients who were undergoing TAVI and did not have an indication for long-term anticoagulation, in a 1:1 ratio, to receive aspirin alone or aspirin plus clopidogrel for 3 months. The two primary outcomes were all bleeding (including minor, major, and life-threatening or disabling bleeding) and non-procedure-related bleeding over a period of 12 months. Most bleeding at the TAVI puncture site was counted as non-procedure-related. The two secondary outcomes were a composite of death from cardiovascular causes, non-procedure-related bleeding, stroke, or myocardial infarction (secondary composite 1) and a composite of death from cardiovascular causes, ischemic stroke, or myocardial infarction (secondary composite 2) at 1 year, with both outcomes tested sequentially for noninferiority (noninferiority margin, 7.5 percentage points) and superiority. RESULTS: A total of 331 patients were assigned to receive aspirin alone and 334 were assigned to receive aspirin plus clopidogrel. A bleeding event occurred in 50 patients (15.1%) receiving aspirin alone and in 89 (26.6%) receiving aspirin plus clopidogrel (risk ratio, 0.57; 95% confidence interval [CI], 0.42 to 0.77; P = 0.001). Non-procedure-related bleeding occurred in 50 patients (15.1%) and 83 patients (24.9%), respectively (risk ratio, 0.61; 95% CI, 0.44 to 0.83; P = 0.005). A secondary composite 1 event occurred in 76 patients (23.0%) receiving aspirin alone and in 104 (31.1%) receiving aspirin plus clopidogrel (difference, -8.2 percentage points; 95% CI for noninferiority, -14.9 to -1.5; P<0.001; risk ratio, 0.74; 95% CI for superiority, 0.57 to 0.95; P = 0.04). A secondary composite 2 event occurred in 32 patients (9.7%) and 33 patients (9.9%), respectively (difference, -0.2 percentage points; 95% CI for noninferiority, -4.7 to 4.3; P = 0.004; risk ratio, 0.98; 95% CI for superiority, 0.62 to 1.55; P = 0.93). A total of 44 patients (13.3%) and 32 (9.6%), respectively, received oral anticoagulation during the trial. CONCLUSIONS: Among patients undergoing TAVI who did not have an indication for oral anticoagulation, the incidence of bleeding and the composite of bleeding or thromboembolic events at 1 year were significantly less frequent with aspirin than with aspirin plus clopidogrel administered for 3 months. (Funded by the Netherlands Organization for Health Research and Development; POPular TAVI EU Clinical Trials Register number, 2013-003125-28; ClinicalTrials.gov number, NCT02247128.).

Anticoagulation with or without Clopidogrel after Transcatheter Aortic-Valve Implantation.

BACKGROUND: The roles of anticoagulation alone or with an antiplatelet agent after transcatheter aortic-valve implantation (TAVI) have not been well studied. METHODS: We performed a randomized trial of clopidogrel in patients undergoing TAVI who were receiving oral anticoagulation for appropriate indications. Patients were assigned before TAVI in a 1:1 ratio not to receive clopidogrel or to receive clopidogrel for 3 months. The two primary outcomes were all bleeding and non-procedure-related bleeding over a period of 12 months. Procedure-related bleeding was defined as Bleeding Academic Research Consortium type 4 severe bleeding, and therefore most bleeding at the puncture site was counted as non-procedure-related. The two secondary outcomes were a composite of death from cardiovascular causes, non-procedure-related bleeding, stroke, or myocardial infarction at 12 months (secondary composite 1) and a composite of death from cardiovascular causes, ischemic stroke, or myocardial infarction (secondary composite 2), both tested for noninferiority (noninferiority margin, 7.5 percentage points) and superiority. RESULTS: Bleeding occurred in 34 of the 157 patients (21.7%) receiving oral anticoagulation alone and in 54 of the 156 (34.6%) receiving oral anticoagulation plus clopidogrel (risk ratio, 0.63; 95% confidence interval [CI], 0.43 to 0.90; P = 0.01); most bleeding events were at the TAVI access site. Non-procedure-related bleeding occurred in 34 patients (21.7%) and in 53 (34.0%), respectively (risk ratio, 0.64; 95% CI, 0.44 to 0.92; P = 0.02). Most bleeding occurred in the first month and was minor. A secondary composite 1 event occurred in 49 patients (31.2%) receiving oral anticoagulation alone and in 71 (45.5%) receiving oral anticoagulation plus clopidogrel (difference, -14.3 percentage points; 95% CI for noninferiority, -25.0 to -3.6; risk ratio, 0.69; 95% CI for superiority, 0.51 to 0.92). A secondary composite 2 event occurred in 21 patients (13.4%) and in 27 (17.3%), respectively (difference, -3.9 percentage points; 95% CI for noninferiority, -11.9 to 4.0; risk ratio, 0.77; 95% CI for superiority, 0.46 to 1.31). CONCLUSIONS: In patients undergoing TAVI who were receiving oral anticoagulation, the incidence of serious bleeding over a period of 1 month or 1 year was lower with oral anticoagulation alone than with oral anticoagulation plus clopidogrel. (Funded by the Netherlands Organization for Health Research and Development; POPular TAVI EU Clinical Trials Register number, 2013-003125-28; ClinicalTrials.gov number, NCT02247128.).

Insight on patient specific computer modeling of transcatheter aortic valve implantation in patients with bicuspid aortic valve disease.

OBJECTIVE: The aim of this study was to describe the early use of dedicated patient specific computer modeling in patients with bicuspid aortic valve (BAV) undergoing transcatheter aortic valve implantation (TAVI), in predicting procedure feasibility and patient related outcome. BACKGROUND: Dedicated patient specific computer modeling, used for optimizing TAVI procedures, is currently validated for the prediction of contact pressure, valve morphology and paravalvular leakage (PVL). The simulation of TAVI procedures is increasingly used in patients with tricuspid aortic valve stenosis. Currently, BAV disease is considered as a relative contra-indication for TAVI due to its specific anatomical characteristics. METHODS: This single center study consisted of seven patients with BAV undergoing TAVI. A patient specific computer simulation was performed based on multislice computer tomography images. The model advised the best fitting prosthetic valve size or sizes and simulated this valve on different implantation depths with the corresponding presence and severity of PVL and prosthetic valve morphology. The simulation results were compared with the procedural outcomes using transesophageal echocardiography (TEE) and fluoroscopy. RESULTS: The patient specific computer modeling predicted accurately the outcome (PVL and valve morphology) of TAVI in all cases. In one case, the TAVI procedure was unsuccessful and retrospectively not suitable for TAVI, which was correctly predicted by the model. CONCLUSION: The patient specific computer modeling adequately predicts feasibility and outcome of TAVI in patients with BAV disease and may extend the applicability of TAVI. Moreover, it improves decision-making and therefore individual procedural outcomes in this difficult patient population.

Transcatheter Tricuspid Valve Interventions: An Emerging Field.

PURPOSE OF REVIEW: This review aims to provide an updated overview and a clinical perspective on novel transcatheter tricuspid valve interventions (TTVI), highlighting potential challenges and future directions. RECENT FINDINGS: Severe tricuspid regurgitation (TR) is a predictor of mortality. However, a sizeable number of patients remain untreated until the end-stage when cardiac surgery presents a prohibitive risk. The emergent need in finding a treatment for patients with TR, deemed for surgery options, has encouraged the development of TTVI. These procedures mimic classical surgery techniques and are mainly divided in four categories: annuloplasty and coaptation devices, edge-to-edge techniques and transcatheter tricuspid valve replacement. Early studies showed promising results, but long-term follow-up data are not available. For patients with severe TR and high surgical risk, several percutaneous options are available. However, these therapies are in a growing phase and bigger studies and long term follow-up are needed to prove their efficacy.

First report of the use of long-tapered sirolimus-eluting coronary stent for the treatment of chronic total occlusions with the hybrid algorithm.

BACKGROUND: Coronary chronic total occlusions (CTO) usually coexist with diffusely diseased coronary segments proximal and/or distal to the CTO segment. During percutaneous treatment of CTO, multiple overlapping stents are often needed to treat these long lesions. OBJECTIVES: Aim of this study is to report the first use of long, tapered coronary sirolimus-eluting stents (SES) in this setting. METHODS AND RESULTS: This is a retrospective analysis of 100 consecutive patients undergoing CTO recanalization following the hybrid algorithm. Procedural success rate was 89% (11 failures). Among the successful cases, "conventional" drug-eluting stents(DES) were used in 40(44.9%) patients, while in 49(55%) patients long-tapered SES were attempted with a success rate of 98% (1 cross-over to regular stents). Total stent length in the long-tapered DES group was higher compared to the "conventional" stenting group (76 ± 28 mm vs 46 ± 22 mm, P < .001), with a similar total number of stent (1.6 ± 0.8 vs 1.9 ± 0.8). At quantitative coronary analysis, proximal and distal segment involvement was more extended in patients undergoing long-tapered stenting, with longer overall lesion length. No differences in periprocedural complications and clinical outcomes at a mean follow-up of 303 ± 179 days were observed. CONCLUSIONS: The use of long tapered coronary DES is technically feasible and safe for the percutaneous treatment of CTOs, especially for patients presenting with long lesions.

Long-term survival and preprocedural predictors of mortality in high surgical risk patients undergoing percutaneous mitral valve repair.

OBJECTIVES: To evaluate long-term survival in high surgical risk patients undergoing percutaneous mitral valve repair (MVR) using the MitraClip(®) system and to identify preprocedural predictors of long-term mortality. BACKGROUND: Data for long-term survival and preprocedural predictors of mortality after percutaneous MVR in high surgical risk patients are sporadic. METHODS: From January 2009 to April 2013, 136 consecutive high surgical risk patients, with symptomatic moderate-to-severe or severe mitral regurgitation (MR), underwent percutaneous MVR using the MitraClip system. Cardiac and overall survival was determined at one and 2 years postprocedure. Univariate and multivariate analysis was performed to identify preprocedural predictors of long-term mortality. RESULTS: One year postprocedure, cardiac and overall survival was 86.7% and 84.6%, respectively and at 2 years cardiac and overall survival was 77.7% and 74.8%, respectively. In univariate analysis advanced age, lower body mass index, impaired renal function, elevated levels of log-N-terminal-pro-brain-natriuretic-peptide (log-NTproBNP), poor performance in functional tests (New York Heart Association (NYHA) class) and high logistic Euroscore (LES) and Society of Thoracic Surgeons (STS) score were identified as preprocedural predictors of long-term cardiac mortality. In multivariate analysis preoperative NYHA class III and IV, elevated levels of log-NTproBNP and advanced age predicted long-term cardiac mortality. CONCLUSIONS: Percutaneous MVR using the MitraClip system has favorable long-term survival rates in high surgical risk patients. Preprocedural NYHA functional class III and IV, elevated log-NTproBNP levels and advanced age predict higher long-term cardiac mortality and should be considered during patient selection.

A prospective, postmarket study with the Mguard Prime Embolic Protection Stent in ST-segment elevation myocardial infarction: the International MGuard Prime Observational Study (IMOS Prime).

AIMS: We sought to evaluate the procedural and clinical performances of the MGuard Prime Embolic Protection Stent (EPS) in a "real-world" population with acute ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI). METHODS AND RESULTS: Consecutive STEMI patients meeting the inclusion criteria and undergoing PPCI were enrolled. The primary endpoint was major adverse cardiac events (MACE) at 30 days, defined as the composite of cardiac death, myocardial infarction (Q wave and non-Q wave) or target lesion revascularization (PCI or coronary artery bypass graft). Secondary endpoints included device success, lesion success, and postprocedural reperfusion outcomes: thrombolysis in myocardial infarction (TIMI) flow and ST-segment elevation resolution (STR). A total of 97 patients (62 years, 77% men) were included. Symptom to cathlab time was 238 min. Device and lesion success were 100%. Final TIMI-3 flow was achieved in 91.8%, and STR > 50% in 87% of the patients. MACE at 30 days was 2.2%, which consisted of one case each of target vessel (TV)-myocardial infarction (MI), and non-TV-MI. CONCLUSIONS: The use of the MGuard Prime EPS stent is feasible and safe and could be also effective in achieving myocardial reperfusion in STEMI patients undergoing PPCI.

Incidence, Predictors, and Prognostic Impact of New Permanent Pacemaker Implantation After TAVR With Self-Expanding Valves.

OBJECTIVES: The authors sought to evaluate the incidence, predictors, and outcomes of new permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement (TAVR) with contemporary self-expanding valves (SEV). BACKGROUND: Need for PPI is frequent post-TAVR, but conflicting data exist on new-generation SEV and on the prognostic impact of PPI. METHODS: This study included 3,211 patients enrolled in the multicenter NEOPRO (A Multicenter Comparison of Acurate NEO Versus Evolut PRO Transcatheter Heart Valves) and NEOPRO-2 (A Multicenter Comparison of ACURATE NEO2 Versus Evolut PRO/PRO+ Transcatheter Heart Valves 2) registries (January 2012 to December 2021) who underwent transfemoral TAVR with SEV. Implanted transcatheter heart valves (THV) were Acurate neo (n = 1,090), Acurate neo2 (n = 665), Evolut PRO (n = 1,312), and Evolut PRO+ (n = 144). Incidence and predictors of new PPI and 1-year outcomes were evaluated. RESULTS: New PPI was needed in 362 patients (11.3%) within 30 days after TAVR (8.8%, 7.7%, 15.2%, and 10.4%, respectively, after Acurate neo, Acurate neo2, Evolut PRO, and Evolut PRO+). Independent predictors of new PPI were Society of Thoracic Surgeons Predicted Risk of Mortality score, baseline right bundle branch block and depth of THV implantation, both in patients treated with Acurate neo/neo2 and in those treated with Evolut PRO/PRO+. Predischarge reduction in ejection fraction (EF) was more frequent in patients requiring PPI (P = 0.014). New PPI was associated with higher 1-year mortality (16.9% vs 10.8%; adjusted HR: 1.66; 95% CI: 1.13-2.43; P = 0.010), particularly in patients with baseline EF <40% (P for interaction = 0.049). CONCLUSIONS: New PPI was frequently needed after TAVR with SEV (11.3%) and was associated with higher 1-year mortality, particularly in patients with EF <40%. Baseline right bundle branch block and depth of THV implantation independently predicted the need of PPI.

Periprocedural continuation versus interruption of oral anticoagulant drugs during transcatheter aortic valve implantation: rationale and design of the POPular PAUSE TAVI trial.

About one-third of patients undergoing transcatheter aortic valve implantation (TAVI) use oral anticoagulants (OAC), mainly due to atrial fibrillation. General guidelines advise interrupting OAC in patients with a high risk of bleeding undergoing interventions. However, preliminary observational data suggest that the continuation of OAC during TAVI is safe and may reduce the risk of periprocedural thromboembolic events. The Periprocedural Continuation Versus Interruption of Oral Anticoagulant Drugs During Transcatheter Aortic Valve Implantation (POPular PAUSE TAVI) is a multicentre, randomised clinical trial with open-label treatment and blinded endpoint assessment. Patients are randomised 1:1 to periprocedural continuation versus interruption of OAC and are stratified for vitamin K antagonist or direct oral anticoagulant use. The primary endpoint is a composite of cardiovascular mortality, all stroke, myocardial infarction, major vascular complications and type 2-4 bleeding within 30 days after TAVI, according to the Valve Academic Research Consortium-3 criteria. Secondary endpoints include separate individual and composite outcomes, quality of life and cost-effectiveness. Since continuation of OAC is associated with the ancillary benefit that it simplifies periprocedural management, the primary outcome is first analysed for non-inferiority; if non-inferiority is proven, superiority will be tested. Recruitment started in November 2020, and the trial will continue until a total of 858 patients have been included and followed for 90 days. In summary, POPular PAUSE TAVI is the first randomised clinical trial to assess the safety and efficacy of periprocedural continuation versus interruption of OAC in patients undergoing TAVI.

Temporal Trends and Contemporary Outcomes After Transcatheter Aortic Valve Replacement With Evolut PRO/PRO+ Self-Expanding Valves: Insights From the NEOPRO/NEOPRO-2 Registries.

BACKGROUND: In recent years, transcatheter aortic valve replacement (TAVR) techniques and technology have continuously improved. Data regarding the impact of these advancements on outcomes in large real-world settings are still limited. The aim of this study was to investigate temporal trends and assess contemporary outcomes after TAVR with Evolut PRO/PRO+ supra-annular self-expanding valves. METHODS: This study included patients enrolled in the multicenter NEOPRO (A Multicenter Comparison of Acurate NEO Versus Evolut PRO Transcatheter Heart Valves) and NEOPRO-2 (A Multicenter Comparison of ACURATE NEO2 Versus Evolut PRO/PRO+ Transcatheter Heart Valves 2) registries who underwent transfemoral TAVR with Evolut PRO/PRO+. Procedural dates (August 2017 through November 2021) were stratified in quartiles (Q) and used to investigate temporal trends in TAVR outcomes. Predischarge, 30-day Valve Academic Research Consortium-3 defined, and 1-year outcomes were evaluated. RESULTS: In total, 1616 patients from 28 centers were included. Over time, patients had lower Society of Thoracic Surgeon-Predicted Risk of Mortality score (Q1-4, 4.1% [2.8-6.3%], 3.7% [2.6-5.3%], 3.3% [2.4-4.9%], 2.9% [2.2-4.3%]; P<0.001) and more moderate or heavy valve calcification (Q1-4, 80%, 80%, 82%, 88%; P=0.038). Overall Valve Academic Research Consortium-3 technical success was 94.1%, with 30-day and 1-year all-cause mortality of 2.4% and 10%, respectively. Throughout the study period, procedures were associated with higher rates of 30-day device success (Q1-4, 81.2%, 82.2%, 82.0%, 88.0%; Cochran-Armitage P=0.023) and early safety (Q1-4, 66.8%, 67.5%, 74.0%, 77.6%; Cochran-Armitage P<0.001), with fewer permanent pacemaker implantations (Q1-4: 15.3%, 20.0%, 12.1%, 11.6%; Cochran-Armitage P=0.023) and residual mild or greater paravalvular leaks (Q1-4, 50.4%, 42.1%, 36.5%, 35.8%; Cochran-Armitage P<0.001). CONCLUSIONS: TAVR with Evolut PRO/PRO+ self-expanding valve is safe and effective. Despite the treatment of heavier calcified anatomies, procedural outcomes are improving over time with less need for pacemaker implantation and less significant paravalvular leaks.

Comparison of platelet function tests in predicting clinical outcome in patients undergoing coronary stent implantation.

Context High on-treatment platelet reactivity is associated with atherothrombotic events following coronary stent implantation. Objective To evaluate the capability of multiple platelet function tests to predict clinical outcome. Design, Setting, and Patients Prospective, observational, single-center cohort study of 1069 consecutive patients taking clopidogrel undergoing elective coronary stent implantation between December 2005 and December 2007. On-treatment platelet reactivity was measured in parallel by light transmittance aggregometry, Verify Now P2Y12 and Platelet works assays, and the IMPACT-R and the platelet function analysis system (PFA-100) (with the Dade PFA collagen/adenosine diphosphate (ADP) cartridge and Innovance PFA P2Y). Cutoff values for high on-treatment platelet reactivity were established by receiver operating characteristic curve (ROC) analysis. Main Outcome Measurement The primary end point was defined as a composite of all-cause death, nonfatal acute myocardial infarction, stent thrombosis, and ischemic stroke. The primary safety end point included TIMI (Thrombolysis In Myocardial Infarction) criteria major and minor bleeding. Results Kaplan-Meier analysis demonstrated that at 1-year follow-up, the primary end point occurred more frequently in patients with high on-treatment platelet reactivity when assessed by light transmittance aggregometry (52 [11.7%; 95% confidence interval {CI}, 8.9%-15.0%] vs 36 [6.0%;95%CI, 4.2%-8.2%] P.001; n=1049),Verify Now (54 [13.3%; 95% CI, 10.2%-17.0%] vs 37 [5.7%; 95% CI, 4.1%-7.8%]P.001; n=1052), Platelet works (33 [12.6%; 95% CI, 8.8%-17.2%] vs 21 [6.1%;95% CI, 3.8%-9.2%] P=.005; n=606), and Innovance PFA P2Y (18 [12.2%; 95%CI; 7.4%-18.6%] vs 28 [6.3%; 95% CI, 4.3%-8.9%] P=.02; n=588). ROC-curve analysis demonstrated that light transmittance aggregometry (area under the curve[AUC], 0.63; 95% CI, 0.58-0.68), Verify Now (AUC, 0.62; 95% CI, 0.57-0.67), and Platelet works (AUC, 0.61; 95% CI, 0.53-0.69) had modest ability to discriminate between patients with and without primary end point at 1-year follow-up. The IMPACT-R(n=905) and the Siemens PFA Collagen/ADP (n=812) were unable to discriminate between patients with and without the primary end point at 1-year follow-up (all AUCs included 0.50 in the CI). None of the tests identified patients at risk for bleeding. Conclusions Of the platelet function tests assessed, light transmittance aggregometry,Verify Now, Platelet works, and Innovance PFA P2Y were significantly associated with the primary end point. However, the predictive accuracy of these 4 tests was only modest. None of the tests provided accurate prognostic information to identify patients at higher risk of bleeding following stent implantation. Trial Registration clinical trials.gov Identifier: NCT00352014 [corrected].

Impact of Predilatation Prior to Transcatheter Aortic Valve Implantation With the Self-Expanding Acurate neo Device (from the Multicenter NEOPRO Registry).

Safety and feasibility of transfemoral Acurate neo implantation without systematic predilatation are not fully investigated. Our aim was to evaluate the use and impact of pre-implantation balloon aortic valvuloplasty (pre-BAV) before transcatheter aortic valve implantation (TAVI) with Acurate neo. The NEOPRO Registry retrospectively included 1,263 patients who underwent transfemoral TAVI with Acurate neo at 18 centers between January 2012 and March 2018. Information on pre-BAV was available for 1,262 patients (99.9%). Primary end points were pre-discharge moderate-to-severe paravalvular aortic regurgitation (PAR II+), 30-day new permanent pacemaker implantation, and 30-day all-cause mortality or stroke. A total of 1,262 patients who underwent TAVI with (n = 1,051) or without predilatation (n = 211) were included. A reduction in the pre-BAV rate was observed during the study period (from 95.7% in the first date quintile to 78.4% in the last date quintile). Patients who underwent pre-BAV had higher degrees of aortic valve (AV) and left ventricular outflow tract (LVOT) calcification. Primary endpoints were similar between pre-BAV and no pre-BAV groups (PAR II+ 5.5% vs 3.4%, p = 0.214; 30-day permanent pacemaker implantation 9.0% vs 8.0%, p = 0.660; 30-day death or stroke 4.9% vs 4.4%, p = 0.743). The need for postdilatation and other procedural outcomes were comparable between groups. Predilatation did not have a significant impact on primary endpoints across AV and LVOT calcification subgroups (subgroup analyses) and was not independently associated with primary endpoints (multivariate analyses). In conclusion, transfemoral Acurate neo implantation without predilatation appears to be feasible and safe, especially in patients with milder degrees of AV and LVOT calcification.

Implementing a minimally invasive approach (combining radial approach, small guiding catheters and minimization of double access) for coronary chronic total occlusion intervention according to the hybrid algorithm: The Minimalistic Hybrid Algorithm.

Percutaneous recanalization of coronary chronic total occlusions (CTOs) traditionally relies on the use of dual access and large bore catheters, with trans-femoral approach adoption in most of the cases. Aim of this manuscript is to describe an alternative algorithm, that we called "Minimalistic Hybrid Algorithm", in order to minimize the use of double access, large bore catheters, and femoral approach thus reducing patient's discomfort and possibly procedural complications. This algorithm can be interpreted as an evolution of the classic "Hybrid Algorithm" and requires the operator to be confident with all techniques known in this conventional algorithm. Indeed, all possible techniques and approaches of the conventional hybrid approach to treat CTOs are included in a novel diagram for procedural strategy, which offers an alternative sequence of steps to limit, whenever possible, the invasiveness of the procedure. After dividing the cases in "simple" or "complex" CTO lesions according to the available complexity scores and to the "feeling", knowledge and expertise of the operator, a systematic description of the procedural steps is provided. This includes antegrade and retrograde approaches, as well as sub-intimal and intra-luminal techniques, in order to maintain the simpler single-catheter transradial strategies in the first line for the simple CTO, and the adoption of more complex, double access and transfemoral ones in the further steps. The minimalistic hybrid algorithm herein described is a possible alternative sequence of steps in the setting of CTO recanalization, with the potential of limiting the use of double access, large bore catheters, and femoral approach.

Transcatheter Aortic Valve Replacement With Next-Generation Self-Expanding Devices: A Multicenter, Retrospective, Propensity-Matched Comparison of Evolut PRO Versus Acurate neo Transcatheter Heart Valves.

OBJECTIVES: The aim of this study was to compare transcatheter aortic valve replacement (TAVR) with the Acurate neo (NEO) and Evolut PRO (PRO) devices. BACKGROUND: The NEO and PRO bioprostheses are 2 next-generation self-expanding devices developed for TAVR. METHODS: The NEOPRO (A Multicenter Comparison of Acurate NEO Versus Evolut PRO Transcatheter Heart Valves) registry retrospectively included patients who underwent transfemoral TAVR with either NEO or PRO valves at 24 centers between January 2012 and March 2018. One-to-one propensity score matching resulted in 251 pairs. Pre-discharge and 30-day Valve Academic Research Consortium (VARC)-2 defined outcomes were evaluated. Binary logistic regression was performed to adjust the treatment effect for propensity score quintiles. RESULTS: A total of 1,551 patients (n = 1,263 NEO; n = 288 PRO) were included. The mean age was 82 years, and the mean Society of Thoracic Surgeons score was 5.1%. After propensity score matching (n = 502), VARC-2 device success (90.6% vs. 91.6%; p = 0.751) and pre-discharge moderate to severe (II+) paravalvular aortic regurgitation (7.3% vs. 5.7%; p = 0.584) were comparable between the NEO and PRO groups. Furthermore, there were no significant differences in any 30-day clinical outcome between matched NEO and PRO pairs, including all-cause mortality (3.2% vs. 1.2%; p = 0.221), stroke (2.4% vs. 2.8%; p = 1.000), new permanent pacemaker implantation (11.0% vs. 12.8%; p = 0.565), and VARC-2 early safety endpoint (10.6% vs. 10.4%; p = 1.000). Logistic regression on the unmatched cohort confirmed a similar risk of VARC-2 device success, paravalvular aortic regurgitation II+, and 30-day clinical outcomes after NEO and PRO implantation. CONCLUSIONS: In this multicenter registry, transfemoral TAVR with the NEO and PRO bioprostheses was associated with high device success, acceptable rates of paravalvular aortic regurgitation II+, and good 30-day clinical outcomes. After adjusting for potential confounders, short-term outcomes were similar between the devices.

Prognostic Value of Improved Kidney Function After Transcatheter Aortic Valve Implantation for Aortic Stenosis.

Transcatheter aortic valve implantation (TAVI) is associated with acute kidney injury (AKI), but can also improve the kidney function (IKF). We assessed the effects of kidney function changes in relation to baseline kidney function on 2-year clinical outcomes after TAVI. In total, 639 consecutive patients with aortic stenosis who underwent TAVI were stratified into 3 groups according to the ratio of serum creatinine post- to pre-TAVI: IKF (≤0.80; n = 95 [15%]), stable kidney function (0.80 to 1.5; n = 477 [75%]), and AKI (≥1.5; n = 67 [10%]). Different AKI risk scores were compared using receiving-operator characteristics. Median follow-up was 24 (8 to 44) months. At 3 months, the increase in estimated glomerular filtration rate in the IKF group remained, and the decreased estimated glomerular filtration rate in the AKI group recovered. Compared with a stable kidney function, AKI showed a higher 2-year mortality rate (adjusted hazard ratio [HR] 3.69, 95% confidence interval [CI] 2.43 to 5.62) and IKF a lower mortality rate (adjusted hazard ratio 0.53, 95% CI 0.30 to 0.93). AKI also predicted major and life-threatening bleeding (adjusted odds ratio 2.94, 95% CI 1.27 to 6.78). Independent predictors of AKI were chronic kidney disease and pulmonary hypertension. Independent predictors of IKF were female gender, a preserved kidney function, absence of atrial fibrillation, and hemoglobin level. Established AKI risk scores performed moderately and did not differentiate between AKI and IKF. In conclusion, AKI is transient and is independently associated with a higher mortality rate, whereas IKF is sustained and is associated with a lower mortality rate. These effects are independent of baseline kidney function. Further studies are warranted to investigate the role of IKF and generate a dedicated prediction model.

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.

Mortality after percutaneous edge-to-edge mitral valve repair: a contemporary review.

Percutaneous edge-to-edge mitral valve (MV) repair is a relatively new treatment option for mitral regurgitation (MR). After the feasibility and safety having been proved in low-surgical-risk patients, the use of this procedure has shifted more to the treatment of high-risk patients. With the absence of randomized controlled trials (RCT) for this particular subgroup, observational studies try to add evidence to the safety aspect of this procedure. These also provide short- and mid-term mortality figures. Several mortality predictors have been identified, which may help the optimal selection of patients who will benefit most from this technique. In this article we provide an overview of the literature about mortality and its predictors in patients treated with the percutaneous edge-to-edge device.

Survival of transcatheter mitral valve repair compared with surgical and conservative treatment in high-surgical-risk patients.

OBJECTIVES: The goal of this study was to compare survival between transcatheter mitral valve (MV) repair using MitraClip system (Abbott Vascular, Santa Clara, California), MV-surgery, and conservative treatment in high-surgical-risk patients symptomatic with severe mitral valve regurgitation (MR). BACKGROUND: Up to 50% of patients with symptomatic severe MR are denied for surgery due to high perioperative risk. Transcatheter MV repair might be an alternative. METHODS: Consecutive patients (n = 139) treated with transcatheter MV repair were included. Comparator surgically (n = 53) and conservatively (n = 59) treated patients were identified retrospectively. Surgical risk was based on the logistic European System for Cardiac Operative Risk Evaluation (log EuroSCORE) or the presence of relevant risk factors, as judged by the heart team. RESULTS: The log EuroSCORE was higher in the transcatheter MV repair group (23.9 ± 16.1%) than in the surgically (14.2 ± 8.9%) and conservatively (18.7 ± 13.2%, p < 0.0001) treated patients. Left ventricular ejection fraction was higher in surgical patients (43.9 ± 14.4%, p = 0.003), with similar values for the transcatheter MV repair (36.8 ± 15.3%) and conservatively treated (34.5 ± 16.5%) groups. After 1 year of follow-up, the transcatheter MV repair and surgery groups showed similar survival rates (85.8% and 85.2%, respectively), whereas 67.7% of conservatively treated patients survived. The same trend was observed after the second and third years. After weighting for propensity score and controlling for risk factors, both the transcatheter MV repair (hazard ratio [HR]: 0.41, 95% confidence interval [CI]: 0.22 to 0.78, p = 0.006) and surgical (HR: 0.52, 95% CI: 0.30 to 0.88, p = 0.014) groups showed better survival than the conservatively treated group. The transcatheter MV repair and surgical groups did not differ (HR: 1.25, 95% CI: 0.72 to 2.16, p = 0.430). CONCLUSIONS: Despite a higher log EuroSCORE, high-surgical-risk patients with symptomatic severe MR treated with transcatheter MV repair show similar survival rates compared with surgically treated patients, with both displaying survival benefit compared with conservative treatment.

Hybrid myocardial perfusion SPECT/CT coronary angiography and invasive coronary angiography in patients with stable angina pectoris lead to similar treatment decisions.

OBJECTIVES: To evaluate to what extent treatment decisions for patients with stable angina pectoris can be made based on hybrid myocardial perfusion single-photon emission CT (SPECT) and CT coronary angiography (CCTA). It has been shown that hybrid SPECT/CCTA has good performance in the diagnosis of significant coronary artery disease (CAD). The question remains whether these imaging results lead to similar treatment decisions as compared to standalone SPECT and invasive coronary angiography (CA). METHODS: We prospectively included 107 patients (mean age 62.8±10.0 years, 69% male) with stable anginal complaints and an intermediate to high pre-test likelihood for CAD. Hybrid SPECT/CCTA was performed prior to CA in all patients. The study outcome was the treatment decision categorised as: no revascularisation, percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). Treatment decisions were made by two interventional cardiologists and one cardiothoracic surgeon in two steps: first, based on the results of hybrid SPECT/CCTA; second, based on SPECT and CA. RESULTS: Revascularisation (PCI or CABG) was indicated in 54 (50%) patients based on SPECT and CA. Percentage agreement of treatment decisions in all patients based on hybrid SPECT/CCTA versus SPECT and CA on the necessity of revascularisation was 92%. Percentage agreement of treatment decisions in patients with matched, unmatched and normal hybrid SPECT/CCTA findings was 95%, 84% and 100%, respectively. CONCLUSIONS: Panel evaluation shows that patients could be accurately indicated for and deferred from revascularisation based on hybrid SPECT/CCTA.