Quantitative flow ratio-Meta-analysis and systematic review.

INTRODUCTION: Despite of the wide evidence of use fractional flow reserve (FFR), isolated angiography evaluation is still the main tool to indicate percutaneous coronary intervention. Quantitative flow ratio (QFR) is a new functional index to assess functional significance. Recently, few studies have showed the capacity of QFR to predict significance stenosis. The aim of this research has been to describe the evidence of QFR in this clinical setting, to analyze the global diagnosis accuracy of QFR versus FFR and to compare the difference in feasibility between retrospective and prospective analysis. METHODS AND RESULTS: Systematic review of literature was performed. Eligible studies for the meta-analysis were considered those directly evaluating de QFR versus FFR. Pooled values of diagnosis test and summary receiver operator curve were calculated. Main causes of not-perform QFR analysis according to study design were also evaluated. Sixteen studies were included. Good correlation and agreement were showed. Global sensibility, specificity, PPV, and NPV were 0.84, 0.89, 0.80, and 0.92, respectively. Then, 18% of evaluated vessels could not be analyzed. Significant differences were found in the percentage of discarded vessels and the cause of nonperformed analysis between retrospective or prospective analysis. CONCLUSIONS: Excellent correlation and agreement between QFR and FFR was demonstrated. QFR assessment could be improved by its prospective analysis with a dedicated protocol.

Transaxillary transcatheter ACURATE neo aortic valve implantation - The TRANSAX multicenter study.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) via transaxillary (TAx) approach with ACURATE neo valve is an off-label procedure. Our aim was to gather information on ACURATE neo cases implanted via TAx approach and report major outcomes. METHODS AND RESULTS: The TRANSAX Study (NCT04274751) retrospectively gathered patients from nine centres in Europe and North America treated with ACURATE neo valve through TAx approach up to May/2019. Follow up was pre-specified at 1-year and was obtained for all patients. A total of 75 patients (79 ± 10 years; 32% women) were included. Left axillary (72%) and conscious sedation (95.2%) were the most common setting. Risk scores were higher when right axillary artery and surgical cut-down were selected. Severe complications including valve embolization, coronary obstruction, annulus rupture, and procedural mortality did not occur. Cardiac tamponade occurred in two cases (2.7%) with one requiring conversion to open surgery (1.3%). Bail-out stenting and surgical vascular repair were required in 7 (9.3%) and 3 (4%) cases, respectively. The need for new permanent pacemaker was 8%. Procedural success (96%), in-hospital (2.7%), and 1-year mortality (8%) were comparable in all settings. Only one case (1.3%) complicated with cerebrovascular event and one (1.3%) presented moderate aortic regurgitation before discharge. CONCLUSIONS: TAx TAVR procedures with the ACURATE neo valve were presented high success rate and low in-hospital and 1-year mortality.

Fracture of small Mitroflow® aortic bioprosthesis following valve-in-valve transcatheter aortic valve replacement with ACURATE neo valve-From bench testing to clinical practice.

Valve-in-valve (ViV) transcatheter procedures have emerged as a feasible, less-invasive treatment option for bioprosthetic structural valve deterioration. However, in the presence of a small bioprosthesis, a significant residual gradient after ViV procedures often occurs and has been associated with poorer clinical outcomes. We report the use of the self-expandable supra-annular ACURATE neo™ valve to treat degenerated Mitroflow (Sorin) aortic bioprosthesis with severe residual elevated gradients followed by valve fracture with a postdilation using a noncompliant balloon leading to significant reduction in residual gradients. In conclusion, the use of ACURATE neo™ valve followed by the controlled fracture of the surgical bioprosthesis frame with a noncompliant balloon is a safe and effective approach for patients with Mitroflow® failing valves and residual elevated gradient after transcatheter aortic valve replacement.

Transubclavian approach: A competitive access for transcatheter aortic valve implantation as compared to transfemoral.

AIMS: Empirically, transfemoral (TF) approach is the first choice for transcatheter aortic valve implantation (TAVI). We aimed to investigate whether transubclavian (TSc) and TF approaches present comparable major outcomes according to current evidence. METHODS: We systematically searched PubMed, EMBASE, and Cochrane database for studies with symptomatic aortic stenosis patients who underwent TAVI through TF or TSc/axillary access from January/2006 to January/2017. Searched terms were: ("aortic stenosis" OR "transcatheter aortic" OR "TAVI" OR "TAVR") and ("transfemoral" OR "transaxillary" OR "transubclavian"). Major outcomes according to Valve Academic Research Consortium-2 criteria were gathered. The odds ratio (OR) was used as a summary statistic. A random-effects model was used. A fully percutaneous TSc TAVI case from our institution illustrates minimalist approach. RESULTS: Final analysis was made with six studies including 4,504 patients (3,886 TF and 618 TSc). Baseline characteristics of compared groups in individual studies were similar, with the exception of a higher logistic EuroSCORE in the TSc group (23.7 ± 1.92 vs. 21.17 ± 3.51, P = 0.04) and higher prevalence of coronary and peripheral artery disease with OR = 0.67 [95% CI: 0.54-0.83] (P = 0.0003) and OR = 0.08 [95% CI: 0.05-0.12] (P < 0.00001), respectively. TSc group presented comparable 30-day mortality (OR = 1.37; [95%CI: 0.85-2.21]; P = 0.20). There were no differences for procedural success, 30-day stroke rate, need for new pacemaker implantation, major vascular complications, and acute kidney injury requiring dialysis. Also, no differences were found concerning 1-year mortality. CONCLUSIONS: Our study suggests that TSc approach may be, not only an alternative route to TF approach for TAVI, but even a competitive one in certain patients with increased risk of femoral injury.

TAV-in-TAV in patients with prosthesis embolization: Impact of commissural alignment and global outcomes.

BACKGROUND: Optimal strategies to manage embolization of transcatheter aortic valve implantation (TAVI) devices are unclear; valve-in-valve (ViV) is often used. We aimed to describe through one-single center experience its rate, causes, consequences, and management as well as the rate and relevance of commissural alignment (CA) in this context. METHODS: We identified across 1038 TAVI cases, those cases requiring ViV for the management of first device embolization. CA (absence or mild misalignment) after first and second device was assessed by CT or fluoroscopy. RESULTS: A total of 23 cases (2.2%) were identified, 52.3% embolized towards the aorta and 47.7% towards the ventricle. Suboptimal implant height (38%) and embolization at the time of post-dilation (23%) were the most frequent mechanisms together with greater rate of bicuspid valve (p < 0.001) and a trend to greater annular eccentricity. Procedural and 1-year death occurred in 13% and 34%, respectively (vs. 1.1% and 7.8% in the global cohort, p < 0.001). CA was present in 76.9% of the prostheses initially implanted but was only spontaneously achieved in 30.8% of the second ViV device. Adequate CA of both prostheses was identified in only two cases (8.7%). There were no cases of coronary obstruction. CONCLUSIONS: TAVI device embolization mechanisms can often be predicted and prevented. Mortality following bail-out ViV is higher than in regular TAVI procedures but 2/3 of these patients survived beyond 1-year follow-up. In them, valve degeneration or coronary re-access might be particularly challenging since CA was rarely achieved with both devices suggesting that greater efforts should be made in this regard.

Long-Term Results of Bioresorbable Vascular Scaffolds in Patients With In-Stent Restenosis: The RIBS VI Study.

BACKGROUND: In patients with in-stent restenosis (ISR) bioresorbable vascular scaffolds (BVS) provide similar results to drug-coated balloons (DCBs) but are inferior to drug-eluting stents (DES) at 1 year. However, the long-term efficacy of BVS in these patients remains unknown. OBJECTIVES: This study sought to assess the long-term safety and efficacy of BVS in patients with ISR. METHODS: RIBS VI (Restenosis Intrastent: Bioresorbable Vascular Scaffolds Treatment; NCT02672878) and RIBS VI Scoring (Restenosis Intrastent: Bioresorbable Vascular Scaffolds Treatment With Scoring Balloon; NTC03069066) are prospective multicenter studies designed to evaluate the results of BVS in patients with ISR (N = 220). The inclusion and exclusion criteria were identical to those used in the RIBS IV (ISR of DES) (Restenosis Intra-stent of Drug-eluting Stents: Drug-eluting Balloon vs Everolimus-eluting Stent; NCT01239940) and RIBS V (ISR of bare-metal stents) (Restenosis Intra-stent of Bare Metal Stents: Paclitaxel-eluting Balloon vs Everolimus-eluting Stent; NCT01239953) randomized trials (including 249 ISR patients treated with DCBs and 249 ISR patients treated with DES). A prespecified comparison of the long-term results obtained with these treatment modalities (ie, DES, DCBs, and BVS) was performed. RESULTS: Clinical follow-up at 3 years was obtained in all (100%) 718 patients. The 3-year target lesion revascularization rate after BVS was 14.1% (vs 12.9% after DCBs [not significant], and 5.2% after DES [HR: 2.80; 95% CI: 1.47-5.36; P = 0.001]). In a landmark analysis (>1 year), the target lesion revascularization rate after BVS was higher than after DES (adjusted HR: 3.41; 95% CI: 1.15-10.08) and DCBs (adjusted HR: 3.33; 95% CI: 1.14-9.70). Very late vessel thrombosis was also more frequent with BVS (BVS: 1.8%, DCBs: 0.4%, DES: 0%; P = 0.03). CONCLUSIONS: In patients with ISR, late clinical results of DES are superior to those obtained with DCBs and BVS. Beyond the first year, DCBs are safer and more effective than BVS.

Cardiac amyloidosis and left atrial appendage closure. The CAMYLAAC study.

INTRODUCTION AND OBJECTIVES: Transthyretin cardiac amyloidosis (ATTR-CA) patients often have atrial fibrillation and increased bleeding/thrombogenic risks. We aimed to evaluate outcomes of left atrial appendage closure (LAAC) compared with patients without a known diagnosis of CA. METHODS: Comparison at long-term of patients diagnosed with ATTR-CA who underwent LAAC between 2009 and 2020 and those without a known diagnosis of CA. RESULTS: We studied a total of 1159 patients. Forty patients (3.5%) were diagnosed with ATTR-CA; these patients were older and had more comorbidities, higher HAS-BLED and CHA2DS2-VASc scores, and lower left ventricular function. Successful LAAC was achieved in 1137 patients (98.1%) with no differences between groups. Regarding in-hospital and follow-up complications, there were no differences between the groups in ischemic stroke (5% vs 2.5% in those without a known diagnosis of CA; P=.283), hemorrhagic stroke (2.5% and 0.8% in the control group; P=.284), major or minor bleeding. At the 2-year follow-up, there were no significant differences in mortality (ATTR-CA: 20% vs those without known CA: 13.6%, 0.248); however, the at 5-year follow-up, ATTR-CA patients had higher mortality (40% vs 19.2%; P <.001) but this difference was unrelated to hemorrhagic complications or ischemic stroke. CONCLUSIONS: LAAC could reduce the risk of bleeding complications and ischemic cerebrovascular events without increasing the rate of early or mid-term complications. Although long-term survival was impaired in ATTR-CA patients, it was comparable to that of patients without a known diagnosis of CA at the 2-year follow-up, suggesting that LAAC for patients with ATTR-CA might not be futile.

Structural and Functional Evaluation of Coronary Arteries Treated With ABSORB Bioresorbable Vascular Scaffold at 5-Year Follow-Up.

Although complete bioresorbable vascular scaffold (BVS) resorption has been demonstrated at 5-year follow-up, whether corresponding vasomotor function restoration occurs remains unknown. The objective was to simultaneously assess the structural healing response along with vasomotor responses at 5-year follow-up of BVS implantation. We studied consecutive patients treated with ABSORB-BVS at 5-year follow-up (n = 31), who were recruited from a multicenter registry and were contacted to undergo a research protocol-driven repeat coronary angiogram involving intracoronary optical coherence tomography (OCT) and invasive coronary endothelial function testing. Epicardial endothelium-dependent vasomotion was defined as any vasodilatation after intracoronary acetylcholine (ACh), whereas endothelium-independent vasomotion was defined as any vasodilatation after intracoronary nitroglycerine (NTG), using quantitative coronary angiography. The mean implantation time point was 60.5 ± 4.6 months. OCT imaging demonstrated complete scaffold resorption in all patients. New coronary lesions (stenosis >50%) were found in 5 patients (16.1%), 3 of them underwent ad hoc percutaneous revascularization (9.7%). Intracoronary ACh (27 patients) and NTG testing (30 patients) was performed. Quantitative coronary angiography analysis demonstrated vasoconstriction after ACh administration and lack of response to NTG in BVS segments (mean lumen diameter = 2.00 ± 0.61 mm at baseline vs 1.74 ± 0.70 mm post-ACh, p <0.001; 2.05 ± 0.54 mm at baseline vs 2.03 ± 0.50 mm post-NTG, p = 0.69). OCT lumen analysis demonstrated similar vasoconstrictive responses to ACh (mean lumen area = 5.31 ± 2.26 mm2 at baseline vs 5.12 ± 2.55 mm2 post-ACh, p = 0.007) but had a vasodilatory response to NTG (5.96 ± 2.35 mm2 at baseline vs 6.17 ± 2.55 mm2 post-NTG, p<0.001). In conclusion, complete ABSORB-BVS resorption was demonstrated at 5-year follow-up. However, this healing response was associated with endothelium-dependent vasomotor dysfunction within the BVS segment.

Commissural Versus Coronary Optimized Alignment During Transcatheter Aortic Valve Replacement.

OBJECTIVES: The aims of this study were to determine the rate of noncentered coronary ostia and their risk for coronary overlap (CO) and to develop an improved orientation strategy for transcatheter aortic valve replacement (TAVR) devices taking into account anatomical cues to identify patients at risk for CO regardless of commissural alignment and compute an alternative, CO-free TAVR rotation angle for those patients. BACKGROUND: Commissural alignment during TAVR reduces CO risk. However, eccentricity of coronary ostia from the center of the sinus of Valsalva may result in CO even after perfect alignment of TAVR commissures. METHODS: Baseline computed tomography from TAVR candidates helped identify distance from commissures to the right coronary artery (RCA) and the left coronary artery (LCA). Then, for each case, a virtual valve was simulated with ideal commissural or coronary alignment, and the degree of CO was determined. On the basis of the potential BASILICA (bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction) efficacy, 3 groups were defined: no risk for CO (>35° from neocommissure to coronary ostia), moderate risk (20°-35°), and severe risk (≤20°). RESULTS: Computed tomographic studies from 107 patients were included. After excluding 7 patients (poor quality or bicuspid valve), 100 patients were analyzed. The RCA showed greater eccentricity compared with the LCA (18.5° [IQR: 3.3°-12.8°] vs 6.5° [IQR: 3.3°-12.8°]; P < 0.001). The mean intercoronary angle was 140.0° ± 18.7° (95% CI: 136.3°-143.7°). Thirty-two patients had moderate to severe risk for CO (≤35°) despite ideal commissural alignment. Greater coronary eccentricity (cutoff for RCA, 24.5°; cutoff for LCA, 19°) and intercoronary angle >147.5° or <103° were associated with greater risk for moderate to severe CO despite commissural alignment (area under the curve: 0.97; 95% CI: 0.91-0.99). If optimal coronary alignment was simulated, this prevented severe CO in all cases and reduced moderate CO from 27% to 5% (P < 0.001). CONCLUSIONS: One third of patients would have CO during TAVR-in-TAVR despite commissural alignment; a 6-fold decrease in this risk was achieved with optimized coronary alignment. Coronary eccentricity and intercoronary angle were the main predictors.

Accurate commissural alignment during ACURATE neo TAVI procedure. Proof of concept.

INTRODUCTION AND OBJECTIVES: Final position of the neo-commissures is uncontrolled during transcatheter aortic valve implantation (TAVI), potentially hindering coronary access and future procedures. We aimed to develop a standard method to achieve commissural alignment with the ACURATE neo valve. METHODS: The relationship between native and TAVI neo-commissures was analyzed in 11 severe aortic stenosis patients undergoing TAVI. Based on computed tomography analysis, an in silico model was developed to predict final TAVI commissural posts position. A modified implantation technique, accurate commissural alignment (ACA) and a dedicated delivery system were developed. TAVI implants were tested in 3-dimensional (3D) printed models and in vivo. Commissural misalignment and coronary overlap (CO) were analyzed. RESULTS: The in silico model accurately predicted final position of commissural posts irrespective of the implantation technique performed (correlation coefficient, 0.994; 95%CI, 0.989-0.998; P<.001). TAVI implant with patient-specific rotation was simulated in 3D printed models and in 9 patients. ACA-oriented TAVI implants presented adequate commissural alignment in vivo (mean commissural misalignment of 7.7 ±3.9°). None of the ACA oriented implants showed CO, whereas in silico conventional implants predicted CO in 6 of the 9 cases. CONCLUSIONS: Accurate commissural alignment of the ACURATE neo device is feasible by inserting the delivery system with a patient-specific rotation based on computed tomography analysis. This is a simple and reproducible method for commissural alignment that can be potentially used for all kinds of TAVI devices.

Myval versus alternative balloon- and self-expandable transcatheter heart valves: A central core lab analysis of conduction disturbances.

BACKGROUND: Several studies have compared surface electrocardiographic changes following different self-expandable (SE) (Evolut (Medtronic, USA); Acurate (Boston Scientific, USA); Portico (Abbott, USA); and Allegra (NVT, Germany)) and balloon-expandable (BE) Sapien-3 (Edwards Lifesciences, USA) transcatheter heart valves. We aimed to compare these prosthesis with the novel Myval BE prosthesis (Meril Life, India). METHODS: Academic European registry of consecutive patients with severe aortic stenosis who received any of the 6 aforementioned valves. Baseline, post-procedural, and discharge 12­leads electrocardiograms (ECG) were centrally analyzed and compared. RESULTS: A total of 1131 patients were included: 135 Myval (11.9%), 290 Sapien-3 (25.6%), 298 Evolut (26.3%), 180 Acurate (15.9%), 125 Portico (11.1%), and 103 Allegra (9.1%). There were no baseline differences in intraventricular conduction disturbances rate. Compared to the novel BE Myval, there were similar procedural and in-hospital outcomes. Similar rates of early new permanent pacemaker implant (PPI) were observed amongst Myval (7.4%), Sapien-3 (13.4%), and Acurate (9.1%), but Evolut, Portico, and Allegra presented significantly higher rates (18.5%, p = 0.003; 29.5% p < 0.001 and 22%, p = 0.001, respectively). Central analysis of ECGs, unraveled significant prolongation of the PR segment with Evolut, Portico and Allegra whereas Evolut, Acurate, and Portico showed significant QRS widening compared to Myval. However, at discharge no differences in PR segment duration were observed while, Evolut, and Portico- but not Acurate, Allegra or Sapien-3 - still presented significant widening of QRS segment compared to Myval. CONCLUSIONS: After blinded central ECG analysis, the novel Myval balloon-expandable prosthesis was associated with a low rate of early conduction disturbances.

Impact of operators experience on peri-procedural outcomes with Watchman FLX: Insights from the FLX-SPA registry.

BACKGROUND: The Watchman FLX is a device upgrade of the Watchman 2.5 that incorporates several design enhancements intended to simplify left atrial appendage occlusion (LAAO) and improve procedural outcomes. This study compares peri-procedural results of LAAO with Watchman FLX (Boston Scientific, Marlborough, Massachusetts) in centers with varying degrees of experience with the Watchman 2.5 and Watchman FLX. METHODS: Prospective, multicenter, "real-world" registry including consecutive patients undergoing LAAO with the Watchman FLX at 26 Spanish sites (FLX-SPA registry). Implanting centers were classified according to the center's prior experience with the Watchman 2.5. A further division of centers according to whether or not they had performed ≤ 10 or > 10Watchman FLX implants was prespecified at the beginning of the study. Procedural outcomes of institutions stratified according to their experience with the Watchman 2.5 and FLX devices were compared. RESULTS: 359 patients [mean age 75.5 (SD8.1), CHA2DS2-VASc 4.4 (SD1.4), HAS-BLED 3.8(SD0.9)] were included. Global success rate was 98.6%, successful LAAO with the first selected device size was achieved in 95.5% patients and the device was implanted at first attempt in 78.6% cases. There were only 9(2.5%) major peri-procedural complications. No differences in efficacy or safety results according to the centers previous experience with Watchman 2.5 and procedural volume with Watchman FLX existed. CONCLUSIONS: The Watchman FLX attains high procedural success rates with complete LAA sealing in unselected, real-world patients, along with a low incidence of peri-procedural complications, regardless of operators experience with its previous device iteration or the number of Watchman FLX devices implanted.

Management and outcomes of patients with left atrial appendage thrombus prior to percutaneous closure.

OBJECTIVE: Left atrial appendage (LAA) thrombus has heretofore been considered a contraindication to percutaneous LAA closure (LAAC). Data regarding its management are very limited. The aim of this study was to analyse the medical and invasive treatment of patients referred for LAAC in the presence of LAA thrombus. METHODS: This multicentre observational registry included 126 consecutive patients referred for LAAC with LAA thrombus on preprocedural imaging. Treatment strategies included intensification of antithrombotic therapy (IAT) or direct LAAC. The primary and secondary endpoints were a composite of bleeding, stroke and death at 18 months, and procedural success, respectively. RESULTS: IAT was the preferred strategy in 57.9% of patients, with total thrombus resolution observed in 60.3% and 75.3% after initial and subsequent IAT, respectively. Bleeding complications and stroke during IAT occurred in 9.6% and 2.9%, respectively, compared with 3.8% bleeding and no embolic events in the direct LAAC group before the procedure. Procedural success was 90.5% (96.2% vs 86.3% in direct LAAC and IAT group, respectively, p=0.072), without cases of in-hospital thromboembolic complications. The primary endpoint occurred in 29.3% and device-related thrombosis was found in 12.8%, without significant difference according to treatment strategy. Bleeding complications at 18 months occurred in 22.5% vs 10.5% in the IAT and direct LAAC group, respectively (p=0.102). CONCLUSION: In the presence of LAA thrombus, IAT was the initial management strategy in half of our cohort, with initial thrombus resolution in 60% of these, but with a relatively high bleeding rate (~10%). Direct LAAC was feasible, with high procedural success and absence of periprocedural embolic complications. However, a high rate of device-related thrombosis was detected during follow-up.

Scoring balloon predilation before bioresorbable vascular scaffold implantation in patients with in-stent restenosis: the RIBS VI 'scoring' study.

BACKGROUND: Currently drug-eluting stents (DES) and drug-eluting balloons are recommended in patients with in-stent restenosis (ISR). However, the efficacy of bioresorbable vascular scaffolds (BVS) after scoring balloon (SCB) predilation in these patients is unknown. METHODS: RIBS VI (NCT02672878) and RIBS VI 'Scoring' (NCT03069066) are prospective multicentre studies assessing the value of BVS in patients with ISR. Inclusion and exclusion criteria were identical in both studies. Results of conventional BVS implantation (112 patients) were compared with those obtained with systematic SCB therapy before BVS (108 patients). Angiographic follow-up was scheduled for all patients. RESULTS: On late angiography (93% of eligible patients) the in-segment minimal lumen diameter (primary end-point) (1.88 ± 0.5 vs. 1.90 ± 0.4 mm, P = 0.81), % diameter stenosis (28 ± 17 vs. 29 ± 15%), late lumen loss (0.23 ± 0.4 vs. 0.22 ± 0.4 mm) and binary restenosis rate (8.5 vs. 9.3%) were similar in the conventional BVS and SCB + BVS groups, respectively. At 1-year follow-up (100% of patients) target lesion revascularization (TLR) requirement (9.8 vs. 11.1%) was similar with the two strategies. Freedom from cardiac death, myocardial infarction and TLR was 88% and 87%, respectively. Results remained unchanged after adjusting for potential baseline confounders and were consistent in 10 prespecified subgroups. CONCLUSION: This study suggests that results of conventional BVS implantation in patients with ISR are not improved by systematic predilation with SCB. ClinicalTrials.gov ID: NCT02672878 (RIBS VI) and NCT03069066 (RIBS VI 'Scoring').

Self-expandable transcatheter heart valves for aortic stenosis. Short-term outcome and matched hemodynamic performance.

INTRODUCTION AND OBJECTIVES: Aortic self-expandable (SE) transcatheter aortic valve implantation (TAVI) devices are particularly useful for patients with aortic stenosis and small/tortuous vessels, small aortic annuli, or low coronary ostia. However, it is unclear whether the growing range of SE devices shows comparable hemodynamic and clinical outcomes. We aimed to determine the differential hemodynamic (residual valve area and regurgitation) and clinical outcomes of these devices in comparable scenarios. METHODS: All patients were enrolled from 4 institutions and were managed with 4 different SE TAVI devices. Baseline and follow-up clinical data were collected and echocardiographic tests blindly and centrally analyzed. Patients were compared according to valve type and a 1:1 matched comparison was performed according to degree of calcification, aortic annulus dimensions, left ventricular ejection fraction, and body surface area. RESULTS: In total, 514 patients were included (Evolut R/PRO, 217; ACURATE neo, 107; ALLEGRA, 102; Portico, 88). Surgical risk scores were comparable in the unmatched population. No differences were observed in the post-TAVI regurgitation rate and in in-hospital mortality (2.7%). The rate of pacemaker implantation at discharge was significantly different among devices (P=.049), with Portico showing the highest rate (23%) and ACURATE neo the lowest (9.5%); Evolut R/PRO and ALLEGRA had rates of 15.9% and 21.2%, respectively. The adjusted comparison showed worse residual TAVI gradients and aortic valve area with ACURATE neo vs ALLEGRA (P=.001) but the latter had higher risk of valve embolization and a tendency for more cerebrovascular events. CONCLUSIONS: A matched comparison of 4 SE TAVI devices showed no differences regarding residual aortic regurgitation and in-hospital mortality.

Absence of accelerated atherosclerotic disease progression after intracoronary infusion of bone marrow derived mononuclear cells in patients with acute myocardial infarction--angiographic and intravascular ultrasound--results from the TErapia Celular Aplicada al Miocardio Pilot study.

BACKGROUND: We tried to evaluate a putative negative effect on coronary atherosclerosis in patients receiving intracoronary infusion of unfractionated bone marrow mononuclear cells (BMMC) following an acute ST-elevation myocardial infarction. Peripheral blood mononuclear cells or enriched CD133(+) BMMC have been associated with accelerated atherosclerosis of the distal segment of the infarct related artery (IRA). METHODS: Thirty-seven patients with ST-elevation myocardial infarction from the TECAM pilot study underwent intracoronary infusion of autologous BMMC 9 +/- 3.1 days after onset of symptoms. We compared angiographic changes from baseline to 9 months of follow-up in the distal non-stented segment of the IRA, as well as in the contralateral coronary artery, with a matched control group. A subgroup of 15 treated patients underwent additional IVUS within the distal segment of the IRA. RESULTS: No difference between stem cell and control group were found regarding changes in minimum lumen diameter (0.006 +/- 0.42 vs 0.06 +/- 0.41 mm, P = ns) and the percentage of stenosis (-2.68 +/- 12.33% vs -1.78 +/- 8.75%, P = ns) at follow-up. Likewise, no differences were seen regarding changes in the contralateral artery (minimum lumen diameter -0.004 +/- 0.54 mm vs -0.06 +/- 0.35 mm, P = ns). In the intravascular ultrasound substudy, no changes were demonstrated comparing baseline versus follow-up in maximum area stenosis and plaque volume. CONCLUSIONS: In this pilot study, analysis of a subgroup of patients found that intracoronary injection of unfractionated BMMC in patients with acute ST-elevation myocardial infarction was not associated with accelerated atherosclerosis progression at mid term. Prospective, randomised studies in large cohorts with long-term angiographic and intravascular ultrasound follow-up are necessary to determine the safety of this therapy.

Comparison of Figulla Flex® and Amplatzer™ devices for atrial septal defect closure: A meta-analysis.

BACKGROUND: Atrial septal defect (ASD) is one of the most common congenital heart diseases. Percutaneous closure is the preferred treatment, but certain complications remain a concern. The most common devices are AMPLATZER™ (ASO) (St. Jude Medical, St. Paul, MN, USA) and Figulla Flex® septal occluders (FSO) (Occlutech GmbH, Jena, Germany). The present study aimed to assess main differences in outcomes. METHODS: A systematic search in Pubmed and Google scholarship was performed by two independent reviewers for any study comparing ASO and FSO. Searched terms were "Figulla", "Amplatzer", and "atrial septal defect". A random-effects model was used. RESULTS: A total of 11 studies including 1770 patients (897 ASO; 873 FSO) were gathered. Baseline clinical and echocardiographic characteristics were comparable although septal aneurysm was more often reported in patients treated with ASO (32% vs. 25%; p = 0.061). Success rate (94% vs. 95%; OR: 0.81; 95% CI: 0.38-1.71; p = 0.58) and peri-procedural complications were comparable. Procedures were shorter, requiring less fluoroscopy time with an FSO device (OR: 0.59; 95% CI: 0.20-0.97; p = 0.003). Although the global rate of complications in long-term was similar, the ASO device was associated with a higher rate of supraventricular arrhythmias (14.7% vs. 7.8%, p = 0.009). CONCLUSIONS: Percutaneous closure of ASD is a safe and effective, irrespective of the type of device. No differences exist regarding procedural success between the ASO and FSO devices but the last was associated to shorter procedure time, less radiation, and lower rate of supraventricular arrhythmias in follow-up. Late cardiac perforation did not occur and death in the follow-up was exceptional.

Angiography and Optical Coherence Tomography Assessment of the Drug-Coated Balloon ESSENTIAL for the Treatment of In-Stent Restenosis.

OBJECTIVES: This study sought to assess the efficacy of the drug-coated balloon (DCB) ESSENTIAL for the treatment of in-stent restenosis (ISR). BACKGROUND: DCBs have proven a valid therapeutic option for the management of ISR in several clinical trials, yet no class effect can be claimed. Accordingly, every new DCB model has to be individually evaluated through clinical studies. METHODS: This is a prospective, multicenter study including consecutive patients undergoing percutaneous coronary intervention for ISR with the ESSENTIAL DCB. A 6-month quantitative coronary angiography (QCA)/optical coherence tomography (OCT) follow-up was scheduled. The primary endpoint was OCT-derived in-segment maximal area stenosis. Secondary endpoints included QCA-derived in-segment late lumen loss (LLL) and target lesion failure (TLF) rates at 6, 12, and 24 months. TLF was defined as the composite of cardiac death, target vessel myocardial infarction, and target lesion revascularization. RESULTS: A total of 31 patients were successfully treated with DCB, with 67% of ISR corresponding to drug-eluting stents (DES). At 6 months, 26 patients underwent the scheduled angiographic follow-up. The mean value for in-segment maximal area stenosis was 51.4 ±â€¯13% and the median value was 53% (IQR 46.4-59.5). In the DES-ISR subgroup, these parameters were 52.6 ±â€¯10% and 55.2% (IQR 49.3-58.5), respectively. In-segment LLL was 0.25 ±â€¯0.43 mm with only 2 (7.7%) patients showing binary restenosis (>50%). The incidence of TLF was 10% at 6 months, 13.3% at 12 months, and 13.3% at 24 months. CONCLUSIONS: In this study, the ESSENTIAL DCB showed sustained efficacy in the prevention of recurrent restenosis after treatment of ISR. SUMMARY: We sought to assess the efficacy of the drug-coated balloon ESSENTIAL for the treatment of in-stent restenosis through a prospective, multicenter study including QCA and OCT assessment at 6-month follow-up. The primary endpoint was in-segment maximal area stenosis. Among the 31 patients successfully treated with the ESSENTIAL DCB, an angiographic follow-up was conducted in 26. Mean in-segment maximal area stenosis was 51.4 ±â€¯13% and the median value was 53% (IQR 46.4-59.5). In the DES-ISR subgroup, corresponding values were 52.6 ±â€¯10% and 55.2% (IQR 49.3-58.5), respectively. The observed in-segment LLL was 0.25 ±â€¯0.43 mm and binary restenosis rate was 7.7%. TLF was 10% at 6 months and 13.3% at 12 and 24 months.