Leaflet modification before transcatheter aortic valve implantation in patients at risk for coronary obstruction: the ShortCut study.

BACKGROUND AND AIMS: This trial sought to assess the safety and efficacy of ShortCut, the first dedicated leaflet modification device, prior to transcatheter aortic valve implantation (TAVI) in patients at risk for coronary artery obstruction. METHODS: This pivotal prospective study enrolled patients with failed bioprosthetic aortic valves scheduled to undergo TAVI and were at risk for coronary artery obstruction. The primary safety endpoint was procedure-related mortality or stroke at discharge or 7 days, and the primary efficacy endpoint was per-patient leaflet splitting success. Independent angiographic, echocardiographic, and computed tomography core laboratories assessed all images. Safety events were adjudicated by a clinical events committee and data safety monitoring board. RESULTS: Sixty eligible patients were treated (77.0 ± 9.6 years, 70% female, 96.7% failed surgical bioprosthetic valves, 63.3% single splitting and 36.7% dual splitting) at 22 clinical sites. Successful leaflet splitting was achieved in all (100%; 95% confidence interval [CI] 94-100.0%, p<0.001) patients. Procedure time, including imaging confirmation of leaflet splitting, was 30.6 ± 17.9 min. Freedom from the primary safety endpoint was achieved in 59 (98.3%; 95% CI [91.1-100%]) patients, with no mortality and one (1.7%) disabling stroke. At 30 days, freedom from coronary obstruction was 95% (95% CI 86.1-99.0%). Within 90 days, freedom from mortality was 95% (95% CI 86.1-99.0%]), without any cardiovascular deaths. CONCLUSIONS: Modification of failed bioprosthetic aortic valve leaflets using ShortCut was safe, achieved successful leaflet splitting in all patients, and was associated with favorable clinical outcomes in patients at risk for coronary obstruction undergoing TAVI.

Conduction disorders following transcatheter aortic valve replacement using acurate Neo2 transcatheter heart valve: A propensity matched analysis.

BACKGROUND: The ACURATE neo2 transcatheter aortic valve was developed to improve paravalvular leak (PVL) rates while maintaining low rates of conduction disturbances and permanent pacemaker implantation (PPMI) seen with its predecessor. We aimed to compare conduction disturbances rates of transcatheter aortic valve replacement (TAVR) using ACURATE Neo2 with other commonly used valves. METHODS: A retrospective analysis of the Israeli TAVR registry between the years 2014-2023 was performed to compare conduction disturbances and PVL rates, and procedural outcomes, among patients treated with ACURATE neo2, Edwards Sapien 3 (S3), and Evolut PRO valves. Propensity score matching was performed to compare groups with similar characteristics. RESULTS: Following exclusion of patients with non-femoral access, unknown valve type, older-generation valves, and less commonly used valves or (n = 4387), our analysis included 3208 patients undergoing TAVR using ACURATE neo2, Edwards S3, and Evolut PRO valves. Propensity matched groups comprised 169 patients each. Rates of any conduction disturbances [left bundle branch block (LBBB), atrioventricular block, or PPMI] were lower in the ACURATE neo2 group compared to both other valves [15.8 %, S3-37.5 % (p < 0.001), Evolut PRO-27.5 % (p = 0.02)] as were LBBB rates [9.0 %, S3-31.3 % (p < 0.001); Evolut PRO-20.1 % (p = 0.01). Atrioventricular block and PPMI rates were lower without statistical significance, as were rates of above-moderate PVL. CONCLUSIONS: In this analysis, TAVR using ACURATE neo2 was associated with a lower composite rate of conduction disturbances in comparison to the Evolut PRO and Edwards S3 valves, mainly due to lower left bundle branch block rates, with non-significantly lower rates of PPMI and PVL.

Culprit Lesion Coronary Intervention Before Complete Angiography in ST-Elevation Myocardial Infarction: A Randomized Clinical Trial.

Importance: Rapid reperfusion during primary percutaneous coronary intervention (PCI) is associated with improved outcomes among patients with ST-elevation myocardial infarction (STEMI). Although attempts at reducing the time from STEMI diagnosis to arrival at the catheterization laboratory have been widely investigated, intraprocedural strategies aimed at reducing the time to reperfusion are lacking. Objective: To evaluate the effect of culprit lesion PCI before complete diagnostic coronary angiography (CAG) vs complete CAG followed by culprit lesion PCI on reperfusion times among patients with STEMI. Design, Setting, and Participants: This open-label, prospective, randomized clinical trial was conducted between April 1, 2021, and August 31, 2022, among patients admitted to a tertiary center in Jerusalem, Israel, with a diagnosis of STEMI undergoing primary PCI. All patients were followed up for 1 year. Analysis was on an intention-to-treat basis. Intervention: Patients were randomized in a 1:1 ratio to undergo either culprit lesion PCI before complete CAG or complete CAG followed by culprit lesion PCI. Main Outcomes and Measures: A needle-to-balloon time of 10 minutes or less. Results: A total of 216 patients were randomized, with 184 patients (mean [SD] age, 62.9 [12.2] years; 155 men [84.2%]) included in the final intention-to-treat analysis; 90 patients (48.9%) were randomized to undergo culprit lesion PCI before CAG, and 94 (51.1%) were randomized to undergo to CAG followed by PCI. Patients who underwent culprit lesion PCI before complete CAG had a shorter mean (SD) needle-to-balloon time (11.4 [5.9] vs 17.3 [13.3] minutes; P < .001). The primary outcome of a needle-to-balloon time of 10 minutes or less was achieved for 51.1% of patients (46 of 90) who underwent culprit lesion PCI before CAG and for 19.1% of patients (18 of 94) who underwent complete CAG followed by culprit lesion PCI (odds ratio, 4.4 [95% CI, 2.2-9.1]; P < .001). Rates of adverse events were similar between groups. In a subgroup analysis, the effect of culprit lesion PCI before complete CAG on the primary outcome was consistent. There were no differences in rates of in-hospital, 30-day, and 1-year all-cause mortality. Conclusions and Relevance: In this randomized clinical trial of patients with STEMI, culprit lesion PCI before complete CAG resulted in shorter reperfusion times. Larger trials are needed to validate these results and to evaluate the effect on clinical outcomes. Trial Registration: ClinicalTrials.gov Identifier: NCT05415085.

Iliac artery stent dislodgement: a rare transcatheter aortic valve implantation complication.

An 82-year-old male patient with severe, symptomatic aortic stenosis was referred for transcatheter aortic valve implantation.

Immature Platelet Fraction and Clinical Outcomes in Patients Undergoing Transcatheter Aortic Valve Implantation.

INTRODUCTION: Immature platelets or reticulated platelets are newly released thrombocytes. They can be identified by their large size and high RNA cytoplasm concentration. Immature platelet fraction (IPF) represents the percentage of immature circulative platelets relative to the total number of platelets. The role of IPF in patients undergoing transcatheter aortic valve implantation (TAVI) is unknown. The aim of the current trial was to assess the levels of IPF in patients undergoing TAVI and correlation with clinical outcomes. MATERIAL AND METHODS: Immature platelet fraction levels were measured 3 times in all patients (preprocedure, 1-2 days post-procedure and 1-month post-procedure). Immature platelet fraction measurement was carried out using an autoanalyzer (Sysmex XE-2100). Patients were followed for 12 months. Primary outcomes were defined as complications during hospitalizations, rehospitalization, and mortality. RESULTS: Fifty-one patients were included in the study. Mean age was 79.8 (±9.6), and 28 (55%) were women. Twenty-one patients (41%) had complications: Of them, 6 of 21 (29%) occurred during hospitalizations (2-vascular complications; 2-sepsis, 2-implantation of a pacemaker), 9 of 21 (43%) patients were rehospitalized after the index admission, and 6 patients died during the follow-up period. Multivariate Cox regression analysis found that IPF < 7% in at least one of the 3 tests was associated with worse outcomes (hazard ratio 3.42; 95% CI 1.11-10.5, P = .032). CONCLUSION: Immature platelet fraction >7% in patients undergoing TAVI is associated with worse outcomes. Further studies are needed to better understand this phenomenon.

Transcatheter edge-to-edge repair in papillary muscle injury complicating acute myocardial infarction.

AIMS: Acute mitral regurgitation (MR) in the setting of myocardial infarction (MI) may be the result of papillary muscle rupture (PMR). This condition is associated with high morbidity and mortality. We aim to evaluate the feasibility of transcatheter edge-to-edge mitral valve repair (TEER) in this acute setting. METHODS AND RESULTS: We analysed data from the International Registry of MitraClip in Acute Mitral Regurgitation following acute Myocardial Infarction (IREMMI) of 30 centres in Europe, North America, and the middle east. We included patients with post-MI PMR treated with TEER as a salvage procedure, and we evaluated immediate and 30-day outcomes. Twenty-three patients were included in this analysis (9 patients suffered complete papillary muscle rupture, 9 partial and 5 chordal rupture). The patients' mean age was 68 ± 14 years. Patients were at high surgical risk with median EuroSCORE II 27% (IQR 16, 28) and 20 out of 23 (87% were in cardiogenic shock). All patients were treated with vasopressors, and 17 out of 23 patients required mechanical support. TEER procedure was performed on the median 6 days after the index MI date IQR (3, 11). Procedural success was achieved in 87% of patients. The grade of MR was significantly decreased after the procedure. MR reduction to 0 or 1 + was achieved in 13 patients (57%), to 2 + in 7 patients (30%), P < 0.01. V-Wave was reduced from 49 ± 8 mmHg to 26 ± 10 mmHg post-procedure, P < 0.01. Sixteen out of 23 patients (70%) were discharged from hospital and 5 of them required reintervention with surgical mitral valve replacement. No additional death at 1 year was documented. CONCLUSIONS: TEER is a feasible therapy in critically ill patients with PMR due to a recent MI. TEER may have a role as salvage treatment or bridge to surgery in this population.

Mitral valve gradient changes associate with outcomes of patients undergoing transcatheter edge-to-edge repair.

INTRODUCTION: Transcatheter edge-to-edge repair (TEER) is typically used to treat mitral regurgitation (MR) in patients with high surgical risk. Increased post-procedural mitral valve gradient (MVG) may impact mortality and hospitalizations. We aim to evaluate and compare the absolute postprocedural MVG and the change in the MVG effect on outcomes for patients undergoing TEER therapy. METHODS: Patients who underwent TEER for severe MR were divided into two groups, initially by postprocedural absolute MVG, TTE-based at discharge, and then by the difference between preprocedural and postprocedural MVG. Primary endpoints included all-cause mortality and heart failure hospitalization (HFH) during one year after the procedure. RESULTS: The study included 100 patients. The mean MVG increased from 3.39 mmHg immediately after the procedure to 4.83 mmHg the following day, an increase of 1.44 mmHg (p < 0.001). First stratification was by MVG on the day following the procedure - MVG ≤5 mmHg (n = 70) and MVG >5 mmHg (n = 30). There was no significant difference in rates of survival (88.6%, 93.3%, p = 0.716) or HFH (18.6%, 33.3%, p = 0.178). Second stratification was by the difference in preprocedural and postprocedural MVG- delta MVG <3 mmHg (n = 55) and delta MVG ≥3 mmHg (n = 45). While survival rates did not significantly differ (87.3% vs. 93.3%, p = 0.503), delta MVG ≥3 mmHg correlated with higher HFH rates (12.7% vs. 35.6%, p = 0.014). CONCLUSIONS: The MVG of patients undergoing TEER usually increases on the day after the procedure compared to the immediate post-procedure MVG. Higher delta MVG is associated with higher HFH rate.

Clinical and Hemodynamic Outcomes of Balloon-Expandable Mitral Valve-in-Valve Positioning and Asymmetric Deployment: The VIVID Registry.

BACKGROUND: Mitral valve-in-valve (ViV) is associated with suboptimal hemodynamics and rare left ventricular outflow tract (LVOT) obstruction. OBJECTIVES: This study aimed to determine whether device position and asymmetry are associated with these outcomes. METHODS: Patients undergoing SAPIEN 3 (Edwards Lifesciences) mitral ViV included in the VIVID (Valve-in-Valve International Data) Registry were studied. Clinical endpoints are reported according to Mitral Valve Academic Research Consortium definitions. Residual mitral valve stenosis was defined as mean gradient ≥5 mm Hg. Depth of implantation (percentage of transcatheter heart valve [THV] atrial to the bioprosthesis ring) and asymmetry (ratio of 2 measures of THV height) were evaluated. RESULTS: A total of 222 patients meeting the criteria for optimal core lab evaluation were studied (age 74 ± 11.6 years; 61.9% female; STS score = 8.3 ± 7.1). Mean asymmetry was 6.2% ± 4.4%. Mean depth of implantation was 19.0% ± 10.3% atrial. Residual stenosis was common (50%; mean gradient 5.0 ± 2.6 mm Hg). LVOT obstruction occurred in 7 cases (3.2%). Implantation depth was not a predictor of residual stenosis (OR: 1.19 [95% CI: 0.92-1.55]; P = 0.184), but more atrial implantation was protective against LVOT obstruction (0.7% vs 7.1%; P = 0.009; per 10% atrial, OR: 0.48 [95% CI: 0.24-0.98]; P = 0.044). Asymmetry was found to be an independent predictor of residual stenosis (per 10% increase, OR: 2.30 [95% CI: 1.10-4.82]; P = 0.027). CONCLUSIONS: Valve stenosis is common after mitral ViV. Asymmetry was associated with residual stenosis. Depth of implantation on its own was not associated with residual stenosis but was associated with LVOT obstruction. Technical considerations to reduce postdeployment THV asymmetry should be considered.

Late Survival After Valve-in-Valve Transcatheter Aortic Valve Implantation With Balloon- Versus Self-Expandable Valves: Meta-Analysis of Reconstructed Time-to-Event Data.

Valve-in-valve (ViV) transcatheter aortic valve implantation (TAVI) in patients with failed bioprostheses arose as an alternative to redo surgical aortic valve replacement. There is an increasing interest in exploring the differences between self-expanding valves (SEVs) and balloon-expandable valves (BEVs). Our study aimed to evaluate the all-cause mortality in ViV-TAVI with SEV versus BEV in patients with failed bioprostheses. We performed a study-level meta-analysis of reconstructed time-to-event data from Kaplan-Meier curves of studies published by March 30, 2023. A total of 5 studies met our eligibility criteria and included 1,454 patients who underwent ViV-TAVI (862 with SEV and 592 with BEV). Almost all BEVs were iterations of the Edwards BEVs (SAPIEN, SAPIEN XT, and SAPIEN 3) and almost all SEVs were iterations of the Medtronic SEVs (CoreValve/Evolut). During the first year after ViV-TAVI, 67 deaths (11.8%) occurred in patients treated with BEV compared with 92 deaths (11.1%) in patients treated with SEV (hazard ratio 0.92, 95% confidence interval 0.66 to 1.27, p = 0.632). At 8 years of follow-up, the all-cause death was not statistically significantly different between the groups, with mortality rates of 65.4% in the group treated BEV and 58.8% in the group treated with SEV (hazard ratio 0.91, 95% confidence interval 0.75 to 1.09, p = 0.302). The restricted mean survival time was overall 0.25 years greater with SEV than BEV, but this difference was not statistically significant (p = 0.278), which indicates no lifetime gain or loss with SEV in comparison with BEV. There seems to be no difference in terms of all-cause death in ViV-TAVI with SEV versus BEV. Randomized controlled trials are warranted to validate our results.

Prevention of LVOT Obstruction by Device-Mediated Laceration of the Anterior Mitral Valve Leaflet During TMVR.

Left ventricular outflow tract obstruction represents a life-threatening complication in patients undergoing transcatheter mitral valve replacement. Interventional approaches to prevent left ventricular outflow tract obstruction are complex and require exceptional procedural expertise. We demonstrate feasibility and safety of first-in-human device-mediated mechanical laceration of the anterior mitral valve leaflet prior to transapical transcatheter mitral valve replacement. (Level of Difficulty: Advanced.).

Urgent transcatheter edge-to-edge repair for severe mitral regurgitation with flail leaflet in critically Ill patients.

Introduction: Degenerative mitral valve disease (DMR) is a common valvular disorder, with flail leaflets due to ruptured chordae representing an extreme variation of this pathology. Ruptured chordae can present as acute heart failure which requires urgent intervention. While mitral valve surgery is the preferred mode of intervention, many patients have significantly elevated surgical risk and are sometimes considered inoperable. We aim to characterize patients with ruptured chordae undergoing urgent transcatheter edge-to-edge repair (TEER), and to analyze their clinical and echocardiographic outcomes. Methods: We screened all patients who underwent TEER at a tertiary referral center in Israel. We included patients with DMR with flail leaflet due to ruptured chordae and categorized them into elective and critically ill groups. We evaluated the echocardiographic, hemodynamic, and clinical outcomes of these patients. Results: The cohort included 49 patients with DMR due to ruptured chordae and flail leaflet, who underwent TEER. Seventeen patients (35%) underwent urgent intervention and 32 patients (65%) underwent an elective procedure. In the urgent group, the average age of the patient was 80.3, with 41.8% being female. Fourteen patients (82%) received noninvasive ventilation, and three patients (18%) required invasive mechanical ventilation. One patient died due to tamponade, while echo evaluation of the other 16 patients demonstrated successful reduction of ≥2 in the MR grade. Left atrial V wave decreased from 41.6 mmHg to 17.9 mmHg (p < 0.001), and the pulmonic vein flow pattern changed from reversal (68.8%) to a systolic dominant flow in all patients (p = 0.001). After the procedure, 78.5% of patients improved to New York Heart Association (NYHA) class I or II (p < 0.001). There was no significant difference in the overall mortality between the urgent and elective groups, with similar 6 months survival rates for each group. Conclusion: Urgent TEER in patients with ruptured chordae and flail leaflets can be safe and feasible with favorable hemodynamic, echocardiographic, and clinical outcomes.

Predicted vs Observed Valve to Coronary Distance in Valve-in-Valve TAVR: A Computed Tomography Study.

BACKGROUND: Preprocedural computed tomography (CT) workup with assessment of virtual transcatheter heart valve-to-coronary ostia (VTC) distance and transcatheter heart valve-to-sinus (VTS) distances is recommended to assess the risk of coronary obstruction following valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR). OBJECTIVES: The authors sought to investigate the agreement of predicted VTC and VTS distances and observed post-TAVR anatomy on CT and their relationship with transcatheter heart valve (THV) expansion and deployment conditions. METHODS: Fifty-one patients who underwent a balloon-expandable ViV procedure were included in this study. The expansion of the THV stent frame was evaluated at 4 levels: THV inflow, surgical heart valve (SHV) sewing ring, SHV outflow, and THV outflow. Assessment of the VTC/VTS distances was performed on the pre-TAVR CT, and THV-to-coronary ostia and THV-to-sinus distances were assessed on the post-TAVR CT. RESULTS: Following the ViV procedure, the THV stent frame flared toward the outflow but was generally underexpanded at all levels, particularly at the SHV sewing ring level. Postdilatation impacted the extent of THV expansion, resulting in greater expansion than nominal balloon filling at all 4 THV levels (P < 0.001). Observed THV-to-coronary ostia distances were systematically larger than predicted by the VTC distance (mean difference 1.25 ±1.28 mm) in patients with nominal balloon filling but systematically smaller in case of postdilatation (mean difference -0.45 ± 0.52 mm). A similar relationship was observed between VTS and THV-to-sinus distance measurements. CONCLUSIONS: With nominal balloon filling, VTC and VTS distances underestimate postprocedural distances due to THV frame underexpansion. However, postdilatation may lead to distances smaller than predicted due to THV overexpansion at the outflow level.

First-in-Human Dedicated Leaflet Splitting Device for Prevention of Coronary Obstruction in Transcatheter Aortic Valve Replacement.

BACKGROUND: Coronary artery obstruction is a life-threatening complication of transcatheter aortic valve replacement (TAVR) procedures. Current preventive strategies are suboptimal. OBJECTIVES: The aim of this study was to describe bench testing and clinical experience with a novel device that splits valve leaflets that are at risk for causing coronary obstruction after TAVR, allowing normal coronary flow. METHODS: The ShortCut device was initially tested in vitro and preclinically in a porcine model for functionality and safety. The device was subsequently offered to patients at elevated risk for coronary obstruction. Risk for coronary obstruction was based on computed tomography-based anatomical characteristics. Procedure success was determined as patient survival at 30 days with a functioning new valve, without stroke or coronary obstruction. RESULTS: Following a successful completion of bench testing and preclinical trial, the device was used in 8 patients with failed bioprosthetic valves (median age 81 years; IQR: 72-85 years; 37.5% man) at 2 medical centers. A total of 11 leaflets were split: 5 patients (63.5%) were considered at risk for left main obstruction alone, and 3 patients (37.5%) were at risk for double coronary obstruction. All patients underwent successful TAVR without evidence of coronary obstruction. All patients were discharged from the hospital in good clinical condition, and no adverse neurologic events were noted. Procedure success was 100%. CONCLUSIONS: Evaluation of the first dedicated transcatheter leaflet-splitting device shows that the device can successfully split degenerated bioprosthetic valve leaflets. The procedure was safe and successfully prevented coronary obstruction in patients at risk for this complication following TAVR.

Post-transcatheter aortic valve implantation isolated PR prolongation: incidence and clinical significance.

AIMS: Conduction abnormalities post-transcatheter aortic valve implantation (TAVI) are common. Post-TAVI PR prolongation was mainly studied as an adjunct to new-onset bundle branch block. The net effect of isolated PR prolongation (IPRP) without post-TAVI QRS changes is not well known. The aim of this study was to define the incidence and clinical significance of post-TAVI IPRP. METHODS AND RESULTS: A total of 1108 consecutive TAVI patients were reviewed. Patients with IPRP were compared with patients without post-TAVI electrocardiogram (ECG) changes. Clinical outcomes included permanent pacemaker implantation (PPI) and overall mortality. A total of 146 patients with IPRP were compared with 290 patients without post-TAVI ECG changes. At 1 year follow-up, 4 (2.7%) and 7 (2.4%) patients underwent PPI (P = 0.838) and 10 (6.8%) and 25 (8.6%) died (P = 0.521), from the study and control groups, respectively. No patient with IPRP and narrow QRS underwent PPI during 1 year post-TAVI, and all death events were non-cardiac except one unknown cause. Permanent pacemaker implantation rates among patients with IPRP and wide QRS were higher (n = 4, 12.1%), compared with patients with wide QRS without post-TAVI ECG change (n = 3, 4%) however not reaching statistical significance (P = 0.126). Multivariate Cox proportional hazards model demonstrated that in patients with narrow QRS, neither PR prolongation nor baseline or maximal PR intervals was associated with the combined endpoint of PPI and mortality. However, in patients with wide QRS, baseline PR intervals and QRS width, but not PR prolongation were associated with the combined outcome. CONCLUSION: Post-TAVI IPRP in patients with narrow QRS is not associated with adverse outcome. This finding may translate clinically into a more permissive approach to these patients.

Valve-in-Valve Transcatheter Aortic Valve Replacement Versus Redo Surgical Aortic Valve Replacement for Failed Surgical Aortic Bioprostheses: A Systematic Review and Meta-Analysis.

Background In the absence of randomized controlled trials, reports from nonrandomized studies comparing valve-in-valve implantation (ViV) to redo surgical aortic valve replacement (rAVR) have shown inconsistent results. Methods and Results PubMed/MEDLINE, Google Scholar, and CENTRAL (Cochrane Central Register of Controlled Trials) were searched through December 2021. Meta-Analysis of Observational Studies in Epidemiology guidelines were followed. The protocol was registered at the International Prospective Register of Systematic Reviews. Random effects models were applied. The primary outcomes of interest were short-term and midterm mortality. Secondary outcomes included stroke, myocardial infarction, acute renal failure, and permanent pacemaker implantation, as well as prosthetic aortic valve regurgitation, mean transvalvular gradient, and severe prosthesis-patient mismatch. Of 8881 patients included in 15 studies, 4458 (50.2%) underwent ViV and 4423 (49.8%) rAVR. Short-term mortality was 2.8% in patients undergoing ViV compared with 5.0% in patients undergoing rAVR (risk ratio [RR] 0.55 [95% CI, 0.34-0.91], P=0.02). Midterm mortality did not differ in patients undergoing ViV compared with patients undergoing rAVR (hazard ratio, 1.27 [95% CI, 0.72-2.25]). The rate of acute kidney failure was lower following ViV, (RR, 0.54 [95% CI, 0.33-0.88], P=0.02), whereas prosthetic aortic valve regurgitation (RR, 4.18 [95% CI, 1.88-9.3], P=0.003) as well as severe patient-prothesis mismatch (RR, 3.12 [95% CI, 2.35-4.1], P<0.001) occurred more frequently. The mean transvalvular gradient was higher following ViV (standard mean difference, 0.44 [95% CI, 0.15-0.72], P=0.008). There were no significant differences between groups with respect to stroke (P=0.26), myocardial infarction (P=0.93), or pacemaker implantation (P=0.21). Conclusions Results of this meta-analysis demonstrate better short-term mortality after ViV compared with rAVR. Midterm mortality was similar between groups. Given the likely selection bias in these individual reports, an adequately powered multicenter randomized clinical trial with sufficiently long follow-up in patients with low-to-intermediate surgical risk is warranted. Registration URL: crd.york.ac.uk/prospero/. Unique identifier: CRD42021228752.

Aortic Annulus S-Curve: Implications for Transcatheter Aortic Valve Replacement and Related Procedures, Part 1.

Most transcatheter aortic valve replacement-related procedures (eg, transcatheter aortic valve replacement implantation depth, commissural alignment, coronary access, bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction, paravalvular leak closure) require an optimal fluoroscopic viewing angle located somewhere along the aortic annulus S-curve. Chamber views, coronary cusp and coronary anatomy, can be understood along the aortic annulus S-curve. A better understanding of the optimal fluoroscopic viewing angles along the S-curve may translate into increased operator confidence and improved safety and efficacy while reducing procedural time, radiation dose, contrast volume, and complication rates.

Leaflet-splitting device to prevent coronary artery obstruction in valve-in-valve transcatheter aortic valve implantation.

Coronary artery obstruction is a life-threatening complication of transcatheter aortic valve replacement procedures, and current preventive strategies are suboptimal. The novel ShortCut device splits bioprosthetic valve leaflets that are at risk of causing coronary artery obstruction after transcatheter aortic valve implantation, allowing for normal coronary flow. In this video tutorial, we demonstrate a valve-in-valve transcatheter aortic valve implantation using a dedicated leaflet-splitting device for prevention of coronary artery obstruction in transcatheter aortic valve replacement.

Urgent Transcatheter Edge-to-Edge Repair for Severe Mitral Regurgitation in Patients with Refractory Cardiogenic Shock.

Introduction Patients suffering from cardiogenic shock (CS) and mitral regurgitation (MR) demonstrate worse prognosis, with higher mortality rates. We sought to evaluate the effectiveness of urgent valve intervention of the mitral valve, using transcatheter edge-to-edge repair (TEER) procedures in patients presenting with CS in a tertiary Intensive Coronary Care Unit (ICCU). Methods and Results Patients with unremitting CS and severe MR were selected for urgent TEER. Baseline clinical and echocardiographic characteristics were recorded, as well as procedural success (MR severity and hemodynamics), and 30-days and 6-month mortality. Urgent TEER was done in 13 patients, whose average age was 70 years; 12 (92%) of the patients were male. All 13 patients had suffered previous ischemic heart disease-12 (92%) with either acute severe MR or worsening of previously known MR by an acute ischemic event. Using the SCAI criteria, 8 patients (61%) were classified as 'E' (Extreme) category; 4 (31%) were classified as 'C'. At 30 days, 12 out of the 13 patients survived (corresponding to an 8% mortality rate); all of those 12 patients remained alive at 6 months post-admission/procedure. Conclusions The use of TEER was associated with greater 30-day and 6-month survival rates, compared to the worldwide mortality rates of patients admitted with CS. This finding may change the previous paradigm that CS and MR are associated with the worst outcome, and we might be able to offer these patients a safe and effective therapeutic option.