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.

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.

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.

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.

Loeffler Endocarditis: A Unique Presentation of Right-Sided Heart Failure Due to Eosinophil-Induced Endomyocardial Fibrosis.

Loeffler endocarditis is a rare restrictive cardiomyopathy caused by abnormal endomyocardial infiltration of eosinophils, with subsequent tissue damage from degranulation, eventually leading to fibrosis. Although an uncommon entity, it is still a disease with significant morbidity and mortality. Often identified only at late stages, treatment options are limited once fibrosis occurs, usually requiring heart failure medications or surgical intervention. We present a unique case of a woman with remote history of hypereosinophilic syndrome, attributed to treatment of rheumatoid arthritis with infliximab, who presented with symptoms of heart failure refractory to medical management and was found to have Loeffler endocarditis. The severe progression of the disease required surgical intervention with endocardial stripping to treat the right-sided diastolic heart failure.

Effect of TLIF Cage Placement on In Vivo Kinematics.

BACKGROUND: The influence of interbody cage positioning on clinical outcomes following lumbar interbody fusion is not well understood, though it has been hypothesized to play a significant role in stability of the treated level. The purpose of this study was to evaluate any correlations between cage placement in TLIF procedures and post-operative kinematics. METHODS: Thirteen patients who had previously undergone a TLIF procedure were evaluated using the Vertebral Motion Analysis (VMA) system, an automated fluoroscopic method of tracking kinematics in vivo. Upright and recumbent bending platforms were used to guide patients through a set range of motion (ROM) standing up and lying down, respectively, in both flexion-extension (FE) and lateral bending (LB). Intervertebral ROM was measured via fluoroscopic images captured sequentially throughout the movement. DICOM images acquired by the VMA system were used to calculate cage positioning. Intra-rater and inter-rater reliability of TLIF cage position were also assessed. RESULTS: Statistically significant correlations were noted between sagittal cage position and lying LB (r = -0.583, p = 0.047), and coronal cage positioning with both standing (r = 0.672, p = 0.012) and lying LB (r = 0.632, p = 0.027). Additionally, the correlation between sagittal cage position and standing FE was trending towards significance (r = -0.542, p = 0.055). CONCLUSIONS: The intuitive correlation between coronal cage position and both standing and lying lateral bending ROM is supported by the data from this study, suggesting placement closer to midline is optimal for stability. Additionally, the VMA system appears to be a sensitive and repeatable means to obtain information on postoperative kinematic outcomes. Further work to establish the relationship between cage placement, these kinematic outcomes and, potentially, functional pain outcomes seems to be warranted based on the results obtained here.

Stability and Load Sharing Characteristics of a Posterior Dynamic Stabilization Device.

BACKGROUND: Lumbar interbody fusion is a common treatment for a variety of spinal pathologies. It has been hypothesized that insufficient mechanical loading of the interbody graft can prevent proper fusion of the joint. The purpose of this study was to evaluate the mechanical stability and anterior column loading sharing characteristics of a posterior dynamic system compared to titanium rods in an anterior lumbar interbody fusion (ALIF) model. METHODS: Range of motion, interpedicular kinematics and interbody graft loading were measured in human cadaveric lumbar segments tested under a pure moment flexibility testing protocol. RESULTS: Both systems provided significant fixation compared to the intact condition and to an interbody spacer alone in flexion extension and lateral bending. No significant differences in fixation were detected between the devices. A significant decrease in graft loading was detected in flexion for the titanium rod treatment compared to spacer alone. No significant differences in graft loading were detected between the spacer alone and posterior dynamic system or between the posterior dynamic system and the titanium rod. CONCLUSIONS: The results of this study indicate that the posterior dynamic system provides similar fixation compared to that of a titanium rod, however, studies designed to evaluate the efficacy of fixation in a cadaver model may not be sufficiently powered to establish differences in load sharing using the techniques described here.