Snare technique to facilitate 'tall-in-short' redo-TAVR.

An 82-year-old man with a prior history of transcatheter aortic valve replacement (TAVR) with a 23-mm balloon-expandable transcatheter heart valve (THV) presented with bioprosthetic stenosis.

Contemporary experience of mitral transcatheter edge-to-edge repair technology in patients with mitral annular calcification.

BACKGROUND: Mitral annular calcification (MAC) has been an exclusion for many of the earlier pivotal trials that were instrumental in gaining device approval and indications for mitral transcatheter edge-to-edge repair (M-TEER). AIMS: To evaluate the impact of MAC on the procedural durability and success of newer generation MitraClip® systems (G3 and G4 systems). METHODS: Data were collected from Northwell TEER registry. Patients that underwent M-TEER with third or fourth generation MitraClip device were included. Patients were divided into -MAC (none-mild) and +MAC (moderate-severe) groups. Procedural success was defined as ≤ grade 2 + mitral regurgitation (MR) postprocedure, and durability was defined as ≤ grade 2 + MR retention at 1 month and 1 year. Univariate analysis compared outcomes between groups. RESULTS: Of 260 M-TEER patients, 160 were -MAC and 100 were +MAC. Procedural success was comparable; however, there were three patients who required conversion to cardiac surgery during the index hospitalization in the +MAC group versus none in the -MAC group (though this was not statistically significant). At 1-month follow-up, there were no significant differences in MR severity. At 1-year follow-up, +MAC had higher moderate-severe MR (22.1% vs. 7.5%; p = 0.002) and higher mean transmitral gradients (5.3 vs. 4.0 mmHg; p = 0.001) with no differences in mortality, New York Heart Association functional class or ejection fraction. CONCLUSION: In selective patients with high burden of MAC, contemporary M-TEER is safe, and procedural success is similar to patients with none-mild MAC. However, a loss of procedural durability was seen in +MAC group at 1-year follow-up. Further studies with longer follow-ups are required to assess newer mTEER devices and their potential clinical implications in patients with a high burden of MAC.

Fusion Imaging Guidance for Coronary Reaccess After Valve-in-Valve Transcatheter Aortic Valve Replacement.

Coronary reaccess can be difficult after valve-in-valve transcatheter aortic valve replacement. We present a case whereby prior valve-in-valve transcatheter aortic valve replacement created difficulty with coronary reaccess. Computed tomography-fluoroscopy fusion imaging was used for guidance to successfully engage the coronary arteries and perform percutaneous coronary intervention.

Balloon rupture during transcatheter aortic valve replacement.

A distinctive complication with balloon-expandable (BE) THV platforms such as the Edwards Sapien (Edwards Lifescience) is the possibility of balloon rupture during THV deployment. Balloon rupture is a rare occurrence that can result in stroke due to fragment embolism, incomplete THV expansion, and/or vascular injury upon retrieval of the balloon. Careful evaluation of preoperative computed tomography is essential to identify high-risk cases. While annular and left ventricular outflow tract (LVOT) calcification are widely acknowledged as common risks for balloon injury, it's essential to note that balloon injury can manifest at various anatomical sites. In this review, we discuss the mechanism behind balloon rupture, methods to identify cases at a heightened risk of balloon injury, approaches to mitigate the risk of rupture, and percutaneous retrieval strategies.

Role of Cerebral Embolic Protection Devices in Patients Undergoing Transcatheter Aortic Valve Replacement: An Updated Meta-Analysis.

BACKGROUND: Cerebral embolic protection devices (CEPD) capture embolic material in an attempt to reduce ischemic brain injury during transcatheter aortic valve replacement. Prior reports have indicated mixed results regarding the benefits of these devices. With new data emerging, we performed an updated meta-analysis examining the effect of CEPD during transcatheter aortic valve replacement on various clinical, neurological, and safety parameters. METHODS AND RESULTS: A comprehensive review of electronic databases was performed comparing CEPD and no-CEPD in transcatheter aortic valve replacement. Primary clinical outcome was all-cause stroke. Secondary clinical outcomes were disabling stroke and all-cause mortality. Neurological outcomes included worsening of the National Institutes of Health Stroke Scale score, Montreal Cognitive Assessment score from baseline at discharge, presence of new ischemic lesions, and total lesion volume on neuroimaging. Safety outcomes included major or minor vascular complications and stage 2 or 3 acute kidney injury. Seven randomized controlled trials with 4016 patients met the inclusion criteria. There was no statistically significant difference in the primary clinical outcome of all-cause stroke; secondary clinical outcomes of disabling stroke, all-cause mortality, neurological outcomes of National Institutes of Health Stroke Scale score worsening, Montreal Cognitive Assessment worsening, presence of new ischemic lesions, or total lesion volume on diffusion-weighted magnetic resonance imaging between CEPD versus control groups. There was no statistically significant difference in major or minor vascular complications or stage 2 or 3 acute kidney injury between the groups. CONCLUSIONS: The use of CEPD in transcatheter aortic valve replacement was not associated with a statistically significant reduction in the risk of clinical, neurological, and safety outcomes.

Kissing balloon inflation for transcatheter aortic valve replacement and abutting ostial coronary artery stent.

In patients with ostial coronary stents protruding into the aorta, there is concern for stent injury while undergoing transcatheter aortic valve replacement (TAVR) with balloon-expandable transcatheter heart valve (THV). An 82-year-old male with history of symptomatic aortic stenosis, heart failure, and coronary artery disease with multiple interventions to right coronary artery (RCA) and a history of stent fracture requiring stent-in-stent placement one year previously, was evaluated for TAVR. His ostial RCA stent was protruding into the aorta at the level of sinotubular junction, with ostial stent to aortic wall (SAW) distance of 25.2 mm. There was concern for balloon inflation during TAVR leading to stent injury. The RCA was cannulated with a 6 French JR4 guide and wired with 0.014' coronary wire. Appropriately sized noncompliant balloon was advanced into RCA. Under rapid pacing, the coronary balloon was inflated across the RCA ostium followed by simultaneous deployment of THV. Intravascular imaging of the ostial RCA stent revealed no stent fracture. SAW distance is important to determine the possibility of balloon-induced stent injury during valve deployment. In cases where an ostial stent may interact with balloon inflation, kissing-balloon inflation may be performed to prevent stent injury. Learning objective: In patients with ostial coronary stents protruding into the aorta, stent to aortic wall distance is important to determine the possibility of balloon-induced stent injury during balloon-expandable transcatheter heart valve deployment. Kissing-balloon inflation may be performed to prevent stent injury.

Chargemaster Pricing Variation for Commonly Billed Procedures in Interventional Cardiology.

OBJECTIVES: A chargemaster is a database of all of the billable items offered by a hospital with their base price listings. A 2018 executive order required all American hospitals to publish their chargemasters to increase price transparency and reduce healthcare expenditures. Chargemaster listings, however, demonstrate marked variability and inconsistency and have not been associated with consumer benefit. The objective of this study was to analyze chargemasters for commonly billed interventional cardiology procedures across five diverse states to explore relationships between price listings and hospital characteristics, ownership, location, and hospital quality. METHODS: Chargemasters were downloaded from hospitals in five states selected to represent the nation's healthcare diversity. Price listings for five interventional cardiology procedures (percutaneous coronary angiography, coronary angiography, single-vessel angioplasty, single-vessel stent, and percutaneous coronary intervention of acute myocardial infarction) were extracted. Statistical analyses such as the Kruskal-Wallis test were performed to explore relationships between mean chargemaster price listings for each procedure and hospital characteristics, ownership, location, and quality ratings. RESULTS: The median mean chargemaster price of four of the five interventional cardiology procedures significantly differed across all states. Price listings were significantly higher in urban versus rural areas and in general acute care hospitals and state government-owned facilities. The highest prices were found with the highest hospital quality rating. CONCLUSIONS: Chargemaster price listings for common interventional cardiology procedures varied significantly across these five states. Urban and metropolitan hospital location, hospital type, and hospital ownership could be factors driving increased chargemaster procedure prices. Prices were highest at hospitals with the highest quality rating.

Comparison of Periprocedural and Intermediate-Term Outcomes of TAVI in Patients with Ejection Fraction ≤ 20% vs. Patients with 20% < EF ≤ 40.

Treatment of congestive heart failure (CHF) with left ventricular (LV) systolic dysfunction and severe aortic stenosis (AS) is challenging, yet transcatheter aortic valve replacement (TAVR) has emerged as a suitable treatment option in such patients. We compared the periprocedural outcomes of TAVR in patients with an ejection fraction (EF) of ≤20% (VLEF group) to patients with an EF > 20% to ≤40% (LEF group). We included patients with severe AS and reduced LV ejection fraction (LVEF ≤ 40%) who underwent TAVR at four centers within Northwell Health between January 2016 and December 2020. Over 2000 consecutive patients were analyzed, of which 355 patients met the inclusion criteria. The primary composite endpoint was in-hospital mortality, moderate or greater paravalvular (PVL), stroke, conversion to open surgery, aortic valve re-intervention, and/or need for PPM. Secondary endpoints were length of stay, NYHA classification at 1 month and 1 year, mortality at 1 month and 1 year, mean valve gradient at 1 month, KCCQ score at 1 month, and ≥ moderate PVL at 1 month. There was no difference in the primary composite endpoint between the two groups (23.6% for VLEF vs. 25.3% for LEF, p = 0.29). During TAVR placement, 40% of patients in the VLEF group required ≥1 vasopressors for hypotension lasting ≥30 min vs. only 21% of patients in the LEF group (p < 0.01). Intra-aortic balloon pump (IABP) use during procedure was greater in the VLEF group (9% vs. 1%, p < 0.01)-all placed post TAVR. Emergency ECMO use was higher in the VLEF group as well (5% vs. 0%). Total length of stay was significantly different between the two groups as well (6 days vs. 3 days, p < 0.01). Both groups had a change in LVEF of ~10%. One-year outcomes were similar between the groups. All-cause mortality at 1 year was not significantly different at 1 year (13% for VLEF vs. 11% for LEF), and KCC scores were also similar (77.54 vs. 74.97). Mean aortic valve gradients were also similar (12 mmHg vs. 11 mmHg, p = 0.48). Our study suggests that patients with EF ≤ 20% can safely have TAVR with similar periprocedural outcomes compared to patients with EF > 20% to ≤40% despite higher rates of vasopressor and mechanical support.

Utility of Multidetector Computed Tomographic Angiography as an Alternative to Transesophageal Echocardiogram for Preoperative Transcatheter Mitral Valve Repair Planning.

BACKGROUND: Three-dimensional (3D) transesophageal echocardiogram (TEE) is the gold standard for the diagnosis of degenerative mitral regurgitation (dMR) and preoperative planning for transcatheter mitral valve repair (TMVr). TEE is an invasive modality requiring anesthesia and esophageal intubation. The severe acute respiratory syndrome coronavirus 2 pandemic has limited the number of elective invasive procedures. Multi-detector computed tomographic angiography (MDCT) provides high-resolution images and 3D reconstructions to assess complex mitral anatomy. We hypothesized that MDCT would reveal similar information to TEE relevant to TMVr, thus deferring the need for a preoperative TEE in certain situations like during a pandemic. METHODS: We retrospectively analyzed data on patients who underwent or were evaluated for TMVr for dMR with preoperative MDCT and TEE between 2017 and 2019. Two TEE and 2 MDCT readers, blinded to patient outcome, analyzed: leaflet pathology (flail, degenerative, mixed), leaflet location, mitral valve area (MVA), flail width/gap, anterior-posterior (AP) and commissural diameters, posterior leaflet length, leaflet thickness, presence of mitral valve cleft and degree of mitral annular calcification (MAC). RESULTS: A total of 22 (out of 87) patients had preoperative MDCT. MDCT correctly identified the leaflet pathology in 77% (17/22), flail leaflet in 91% (10/11), MAC degree in 91% (10/11) and the dysfunctional leaflet location in 95% (21/22) of patients. There were no differences in the measurements for MVA, flail width, commissural or AP diameter, posterior leaflet length, and leaflet thickness. MDCT overestimated the measurements of flail gap. CONCLUSIONS: For preoperative TMVr planning, MDCT provided similar measurements to TEE in our study.

Short- and Mid-Term Outcomes of Complex and High-Risk Versus Standard Percutaneous Coronary Interventions in Patients Undergoing Transcatheter Aortic Valve Replacement.

BACKGROUND: The prevalence of coronary artery disease (CAD) in patients undergoing TAVR varies and is associated with increased morbidity and mortality. We evaluated the outcomes of complex and high-risk percutaneous coronary interventions (CHIP-PCIs) and TAVR compared with standard PCI and TAVR. Between January 2014 and March 2021, a total of 276 consecutive patients with severe aortic stenosis (AS) who underwent TAVR and PCI at 3 centers within Northwell Health were retrospectively reviewed. CHIP-PCI was defined as PCI with one of the following: left ventricular ejection fraction (LVEF) <30%; left main coronary artery (LMCA)/chronic total occlusion (CTO) intervention; atherectomy; or need for left ventricular (LV) support. One hundred twenty- seven patients (46%) had CHIP-PCI prior to TAVR and 149 patients (54%) had standard PCI. Thirteen percent of CHIP-PCI and 22% of standard PCI cases were done concomitantly with TAVR. CHIP-PCI criteria were met for low EF (19%), LMCA (25%), CTO (3%), LV support (20%), and atherectomy (50%). The types of valves used were similarly divided (49% balloon expandable vs 51% self expanding. Major adverse cardiac or cerebrovascular event (MACCE) rate for CHIP-PCI/TAVR was 4.9% at 30 days vs 1.3% for standard PCI/TAVR (P=.09), driven by in-hospital stroke. At 1 year, the rates of MACCE for CHIP-PCI/TAVR remained higher than for standard PCI/TAVR, but was not statistically significant (8.7% vs 4%; P=.06), driven by revascularization. We found no differences between major and/or minor vascular complications. New York Heart Association classification at 1 month was similar (I/II 93% vs 95%; P=.87). Our study suggests that CHIP-PCI can be safely performed in patients with complex CAD and concomitant severe AS.

Comparison of clinical outcomes between use of overexpanding an undersized versus nominal-sized SAPIEN 3 ultra transcatheter heart valve in patients with borderline annulus area.

BACKGROUND: For patients with borderline annulus areas that fall between two valve sizes, overinflating a smaller balloon-expandable transcatheter heart valve (THV) may be preferable to nominal sizing of a larger THV. OBJECTIVES: To evaluate the outcomes of nominal preparation versus over-expanding an under-sized SAPIEN 3 Ultra (S3U) transcatheter heart valve (OE-THV) in cases with borderline annuli. METHODS: 958 patients that underwent TAVR with the S3U at four high-volume TAVR centers between January 2017 and December 2020 were retrospectively reviewed. 336 patients were identified as borderline annuli size, of which 146 (44%) received OE-THVs and 190 (56%) received nominal-sized THVs. The primary composite endpoint included: in-hospital mortality, aortic injury, moderate/severe paravalvular leak (PVL), permanent pacemaker implant (PPM), stroke, or conversion to surgery. RESULTS: Baseline characteristics were similar except for a larger percentage of females in the OE-THV (53.42% vs. 42.11%, p = 0.04). TAVR with OE-THV resulted a reduction in the primary composite endpoint (13.69% vs. 22.63%, p = 0.04). On subgroup analysis, there was no difference between 20 mm OE-THV versus 23 mm nominal or 23 mm OE-THV versus 26 mm nominal, but there was a reduction in the primary composite endpoint in patients with larger annuli that received a 26 mm OE-THV compared to the 29 mm nominally sized THV (9.7% vs. 27.4%, p = 0.02). At 1 month and 1 year follow-up, there was no significant difference in mortality, PVL rates, NYHA class, and/or KCCQ score. CONCLUSION: Overinflating a smaller-sized S3U THV may be a safer option in comparison to nominal sizing in patients with borderline annular area.

Transcatheter heart valve selection in patients with low ejection fraction and aortic stenosis.

OBJECTIVE: The aim of this study was to compare outcomes of transcatheter heart valve (THV) choice in patients with left ventricular (LV) systolic dysfunction. BACKGROUND: The management congestive heart failure with combined LV systolic dysfunction and severe aortic stenosis (AS) is challenging, yet transcatheter aortic valve replacement (TAVR) has emerged as a suitable treatment option in such patients. Head-to-head comparisons among the balloon-expandable (BEV) and self-expandable (SEV) THV remain limited in this subgroup of patients. METHODS: In this retrospective study, we included patients with severe AS with LV systolic dysfunction (LVEF ≤40%) who underwent TAVR at four high volume centers. Two thousand and twenty-eight consecutive patients were analyzed, of which 335 patients met inclusion criteria. One hundred fourty-six patients (43%) received a SEV, and 189 patients (57%) received a BEV. RESULTS: Baseline characteristics were similar except for a higher proportion of females in the SEV group. The primary composite endpoint of in-hospital mortality, moderate or greater paravalvular (PVL), stroke, conversion to open surgery, aortic valve reintervention, and/or need for permanent pacemaker (PPM) was no different among THV choice. There was more PVL in the SEV group, but higher transaortic gradients in the BEV group. Clinical outcomes and quality of life measures were similar up to 1 year follow-up. CONCLUSION: The choice of THV in patients with severe AS and systolic dysfunction must be weighed on a case-by-case basis.

Lifetime management for aortic stenosis: Planning for future therapies.

A shift to lifetime management has gained more focus with the approval of low-risk transcatheter aortic valve replacement (TAVR). This paper is therefore focused on the different approaches for lifetime management. Herein we discuss the procedural safety, durability, performance, and future options for each lifetime management strategy. In younger patients that elect to undergo surgical aortic valve replacement (SAVR), options for bioprosthetic failure are TAV-in-SAV or redo SAVR. Among patients that undergo TAVR, options for valve failure include TAVR explant with SAVR or TAV-in-TAV. Additionally, there are patients who may require a third valvular intervention. The initial therapy may limit re-intervention options down the road. This review discusses how options for future therapies affect the decision of SAVR vs TAVR in younger patients.

Mitral Regurgitation in the High-Risk Patient: Integrating an Expanding Armamentarium of Transcatheter Devices Into the Treatment Algorithm.

Over the last decade, multiple transcatheter mitral valve repair and replacement strategies have emerged, yet there is only 1 US Food and Drug Administration approved device, the MitraClip (Abbott Vascular, Inc., Santa Clara, CA). Current guidelines support the use of the MitraClip in high or prohibitive surgical risk patients, but there are many patients that are not anatomically suited for the device. This review article discusses the approach to degenerative and functional mitral regurgitation in the high-prohibitive risk patient, how to choose transcatheter treatment options (both approved and investigational), and potential management for therapy failure.

Variability and Reproducibility of the SYNTAX Score for Triple-Vessel Disease.

BACKGROUND: The SYNTAX score (SX) is an angiographic grading system to determine the burden and complexity of coronary artery disease (CAD) and to guide operators as to the appropriateness of percutaneous coronary intervention (PCI) vs coronary artery bypass grafting (CABG). However, variability of the SX may exist since the assessment relies on individual clinicians to visually interpret lesion severity and characteristics. We therefore aimed to assess SX variability and reproducibility among interpreting physicians. METHODS: Fifty patient angiograms were randomly selected from a registry of patients with multi-vessel CAD (treated with PCI or CABG) completed at our institution during the years 2011-2018. Each angiogram was evaluated by 6 clinicians on 2 separate occasions (minimum 8 weeks between occasions) for a total of 600 SX. Our goal was to evaluate both inter- and intra- observer reliability of SX scores. Variation in both raw score as well as risk classification (low, intermediate or high SX) was observed. Inter- and intra-observer reliability were assessed using the intra-class correlation coefficient (ICC), Cohen's weighted Kappa, and Fleiss' Kappa. RESULTS: SYNTAX scores on both assessments and across all 6 cardiologists had a mean score of 25.3. On the first assessment, the ICC for the inter-observer reliability of SX scores was 0.61 (95% CI: 0.50, 0.73). Across the 6 observers, only 16% of angiograms were classified in the same risk classification by all observers. 34% of angiograms had less than a majority agreement (3 or less observers) on risk classification. The weighted Kappa for intra-observer reliability of risk classification scores ranged from 0.30 to 0.81. Across the 6 observers, the proportion of angiograms classified as the same risk classification between each observer's 1st and 2nd assessment ranged from 46% to 84%. CONCLUSION: This study shows a wide inter- and intra- user variability in calculating SX. Our data indicates a significant limitation in using the SX to guide revascularization strategies. Further studies are needed to determine more reliable ways to quantitate burden of CAD.

Tolvaptan add-on therapy and its effects on efficacy parameters and outcomes in patients hospitalized with heart failure.

INTRODUCTION: Even with the adequate use of diuretics and vasodilators, volume overload and congestion are the major causes of morbidity and mortality in patients hospitalized with acute heart failure (HF). We aim to evaluate the additive effect of tolvaptan on efficacy parameters as well as outcomes in hospitalized patients with HF. METHODS: We searched PubMed, EMBASE, Cochrane library, and Web of Science databases for randomized controlled trials that studied the effects of tolvaptan versus placebo in hospitalized patients with HF. Studies were included if they had any of the following endpoints: mortality, re-hospitalization, and in-hospital parameters like dyspnea relief, change in weight, sodium, and creatinine. RESULTS: The meta-analysis analyzed data from 14 studies involving 5945 patients. The follow up duration ranged from 30 days to 2 years. Between tolvaptan and placebo groups, there was no difference in mortality and rehospitalization. HF patients had a better dyspnea relief score (Likert score) in tolvaptan group and mean reduction in weight in the first 48 h (short-term). However, at 7 days (medium-term) the mean difference in weight was not significant. Serum sodium increased significantly in tolvaptan group. There was no difference in creatinine among the two groups. CONCLUSIONS: Our meta-analysis shows that tolvaptan helps in short-term symptomatic dyspnea relief and weight reduction, but there are no long term benefits including reduction in mortality and rehospitalization.

A Novel Computed Tomographic Angiography Tortuosity Index to Predict Successful Sentinel Cerebral Embolic Protection Delivery for Transcatheter Aortic Valve Replacement.

Background: Percutaneous transradial placement of the Sentinel cerebral embolic protection device (CEPD) (Boston Scientific) is indicated during transcatheter aortic valve replacement to capture embolic material in patients without excessive tortuosity of the right subclavian/innominate arteries. We aimed to generate a quantitative tortuosity index (TI) from the preoperative computed tomographic angiography (CTA) as an objective measure of tortuosity to determine suitability for CEPD placement. Methods: Eighty-one patients considered for CEPD were included in this study. A centerline of the right subclavian/innominate arteries was generated from preoperative CTA scans. Three-dimensional Cartesian coordinates of landmarks along the centerline were used to calculate curvature. Tortuosity was derived as a change in angulation along each vessel segment. Peak and average TI values were calculated. Results: Sixty-seven patients had CEPD placement attempted. Unsuccessful CEPD placement occurred in 3 of 67 (4.4%) patients. The peak tortuosity for the successful, unsuccessful, and visually tortuous (not attempted) cohorts were 49.66 ± 11.96°/cm, 113.92 ± 5.70°/cm, and 70.44 ± 17.01°/cm, respectively. The peak and average TI of the successful cohort follows a normal distribution. A proposed TI cutoff for safe CEPD was peak tortuosity of 74°/cm and average tortuosity of 30°/cm, 2 standard deviations above the peak and average TI of the successful cohort. All unsuccessful CEPD patients fell outside the boundaries. Half of the visually tortuous patients were within the boundaries but did not have CEPD attempted. Conclusions: A novel TI based on preoperative CTA can assist in selecting patients for transradial CEPD. Our proposed quantitative tool may help to appropriately include and exclude patients for CEPD placement.