Clinical Outcomes and Cost Analysis in Patients with Heart Failure Undergoing Transcatheter Edge-to-Edge Repair for Mitral Valve Regurgitation.

Objective: To analyze the clinical and cost outcomes of transcatheter edge-to-edge repair (TEER) for mitral regurgitation (MR) in heart failure (HF) patients. Methods: All 162 HF patients undergoing TEER for MR between January 2019 and March 2023 were included. A propensity-adjusted analysis was used to compare 32 systolic vs. 97 diastolic vs. 33 mixed (systolic + diastolic) HF patients. Systolic, diastolic, and mixed HF patients were defined according to AHA guidelines. The primary outcome was the long-term incidence of all-cause death and major adverse cardiovascular and cerebrovascular events (MACCEs, all-cause mortality + stroke + myocardial infarction + repeat intervention). Results: The mean age was 76.3 vs. 80.9 vs. 76 years old, and the mean ejection fraction (EF) was 39.5% vs. 59.8% vs. 39.7% in systolic vs. diastolic vs. mixed HF, respectively. Postoperatively, the diastolic vs. systolic HF group had a higher intensive care unit stay (21 vs. 0 h; HR 67.5 (23.7, 111.4)]; lower ventilation time [2 vs. 2.3 h; HR 49.4 (8.6, 90.2)]; lower EF [38% vs. 58.5%; HR 9.9 (3.7, 16.1)]. In addition, the diastolic vs. mixed HF groups had a lower incidence of EF < 50% (11 vs. 27 patients; HR 6.6 (1.6, 27.3) and a lower use of dialysis (one vs. three patients; HR 18.1 (1.1, 287.3), respectively. At a mean 1.6 years follow-up, all-cause death [HR 39.8 (26.2, 60.5)], MACCEs [HR 50.3 (33.7-75.1)], and new pacemaker implantations [HR 17.3 (8.7, 34.6)] were higher in the mixed group. There was no significant total hospital cost difference among the systolic (USD 106,859) vs. diastolic (USD 91,731) vs. mixed (USD 120,522) HF groups (p = 0.08). Conclusions: TEER for MR evidenced the worst postoperative and follow-up clinical outcomes in the mixed HF group compared to diastolic and systolic HF groups. No total hospital cost differences were observed.

Impact of coronary artery disease and revascularization on outcomes of transcatheter aortic valve replacement for severe aortic stenosis.

BACKGROUND/PURPOSE: To evaluate the impact of coronary artery disease (CAD), percutaneous coronary intervention (PCI), and coronary lesion complexity on outcomes of transcatheter aortic valve replacement (TAVR) for aortic stenosis. METHODS/MATERIALS: This retrospective study included 1042 patients divided into two groups by the presence or absence of CAD (SYNTAX score 0, no history of revascularization). Propensity score matching was used to compare the two groups. The effect of PCI, SYNTAX score, and residual SYNTAX score was also analyzed. RESULTS: The median age of the cohort was 82 years, and 641 patients had CAD. After propensity score matching, 346 pairs were analyzed. During 5 years of follow-up (median: 25, range 0-72 months), the rate of coronary intervention was significantly higher in CAD patients (p = 0.018). However, all-cause mortality, composite of all-cause mortality, stroke, and coronary intervention, and overt bleeding defined by VARC-3 were comparable. After stratification, in patients with creatinine ≥1.5 mg/dl, CAD was associated with a worse composite outcome (p = 0.016). Neither PCI nor SYNTAX score was associated with all-cause mortality in CAD patients. Similarly, residual SYNTAX score showed no association with mortality in patients undergoing PCI (all p values >0.7). PCI did not reach a significant difference in overt bleeding in CAD patients (adjusted p = 0.06). CONCLUSIONS: Despite a higher incidence of coronary interventions, major clinical outcomes were similar between patients with and without CAD after TAVR. In patients with chronic kidney disease, CAD may be associated with an adverse composite outcome. Neither PCI nor SYNTAX/residual SYNTAX score influenced all-cause mortality.

Impact of prior coronary artery bypass grafting and coronary lesion complexity on outcomes of transcatheter aortic valve replacement for severe aortic stenosis.

OBJECTIVE: To investigate the impact of prior coronary artery bypass grafting (CABG) and coronary lesion complexity on transcatheter aortic valve replacement (TAVR) outcomes for aortic stenosis. METHODS: Clinical outcomes of TAVR were retrospectively compared between patients with and without prior CABG, and between patients with prior CABG and without coronary artery disease (CAD). The impact of the CABG SYNTAX score was also evaluated in patients with prior CABG. RESULTS: The study included 1042 patients with a median age and follow-up of 82 years and 25 (range: 0-72) months, respectively. Of these, 175 patients had a history of CABG, while 401 were free of CAD. Patients with prior CABG were more likely to be male and had higher rates of diabetes, peripheral artery disease and atrial fibrillation compared with patients without prior CABG. After 2 : 1 propensity score matching, all-cause mortality ( P  = 0.17) and the composite of all-cause mortality, stroke and coronary intervention ( P  = 0.16) were similar between patients with (n = 166) and without (n = 304) prior CABG. A 1 : 1 propensity score-matched analysis, however, showed lower rates of all-cause mortality ( P  = 0.04) and the composite outcome ( P  = 0.04) in patients with prior CABG (n = 134) compared with patients without CAD (n = 134). The median CABG SYNTAX score was 16 (interquartile range: 9.0-23), which was not associated with better/worse clinical outcomes in patients with prior CABG. CONCLUSION: Prior CABG may positively affect mid-term TAVR outcomes for aortic stenosis compared with no CAD when adjusted for other comorbidities. The CABG SYNTAX score did not influence the prognosis after TAVR.

Impact of mitral stenosis on early and late outcomes of transcatheter aortic valve replacement for aortic stenosis: a single-center analysis.

OBJECTIVES: To assess the impact of concomitant mitral stenosis (MS) on early and late outcomes of transcatheter aortic valve replacement (TAVR) for aortic stenosis. METHODS: This study involved 952 patients undergoing TAVR for severe tricuspid aortic stenosis. The patients were classified into 3 groups: without MS, with progressive MS, and severe MS (mitral valve area ≤ 1.5 cm2). Clinical outcomes between these groups were compared. RESULTS: The median age of the overall cohort was 82 years, and patients in the progressive (n = 49) and severe (n = 24) MS groups were more likely to be female than those in the no-MS group (n = 879). Periprocedural mortality rate was lowest in the no-MS group (1.8%) compared with the progressive (4.1%) and severe (4.2%) MS groups, which were not significantly different (P = .20). During 5 years of follow-up (median: 27, range: 0-72 months), there was no significant difference in all-cause mortality (log-rank P = .99), a composite of all-cause mortality or rehospitalization for heart failure (log-rank P = .84), or cardiovascular death (log-rank P = .57) between groups. Although crude analysis showed a significant difference in rehospitalization for heart failure in the severe MS group compared with the no-MS group (P = .049), the difference was not significant in the multivariate analysis (adjusted hazard ratio: 1.36 [95% CI, 0.66-2.80], P = .41). CONCLUSIONS: TAVR can be safely performed in patients with severe tricuspid aortic stenosis and concomitant MS, with early and mid-term outcomes comparable to those in patients without MS.

Clinical and Echocardiographic Outcomes of Patients Undergoing Transcatheter Edge-to-Edge Repair for Functional vs Degenerative Mitral Valve Regurgitation.

To analyze clinical and echocardiographic outcomes after transcatheter edge-to-edge repair (TEER) with mitral valve clip device (MitraClip-TM) for functional vs degenerative mitral valve regurgitation (MR). All consecutive 185 patients undergoing TEER between January 2019 and March 2023 were included in the study. A propensity-adjusted analysis investigated differences among functional vs degenerative MR mechanism groups. Preoperatively, functional vs degenerative MR included 43 vs 142 patients, respectively. Mean ejection fraction (EF) values were 37% vs 57.8%, mean STS-PROM risk score was 7% vs 4% while patients with severe MR included 29 (67.4%) vs 129 (90.9%) patients, respectively. Postoperatively, functional MR patients experienced a higher incidence of prolonged postoperative length of stay (LOS), reduced creatinine clearance, and EF<50% compared to the degenerative MR group. Mean EF was 35.9% vs 56.2% (P < 0.0001) and 1 (2.3%) vs 16 (11.3%) patients had residual severe MR (P = 0.01) in functional vs degenerative MR groups, respectively. At 30-days follow-up, all-cause death incidence was 1 (2.3%) vs 3 (2.1%) patients in functional vs degenerative MR, respectively (P = 0.9). At a mean of 1.6-years follow-up, all-cause death (P = 0.01), major adverse cardiovascular and cerebrovascular events (MACCE) (P = 0.02), cardiac death (P = 0.01) and hazard ratio for all-cause death higher in functional vs degenerative MR group. Mean EF was 39.7% vs 56% (P < 0.001) while residual severe MR was 4 (9.3%) vs 34 (24.5%) (P = 0.1) in functional vs degenerative MR groups, respectively. TEER with MitraClip device showed a higher incidence of all-cause death, cardiac death, and MACCE at follow-up for functional compared to degenerative MR after TEER.

Echocardiographic Outcomes With Transcatheter Edge-to-Edge Repair for Degenerative Mitral Regurgitation in Prohibitive Surgical Risk Patients.

BACKGROUND: The CLASP IID randomized trial (Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial) demonstrated the safety and effectiveness of the PASCAL system for mitral transcatheter edge-to-edge repair (M-TEER) in patients at prohibitive surgical risk with significant symptomatic degenerative mitral regurgitation (DMR). OBJECTIVES: This study describes the echocardiographic methods and outcomes from the CLASP IID trial and analyzes baseline variables associated with residual mitral regurgitation (MR) ≤1+. METHODS: An independent echocardiographic core laboratory assessed echocardiographic parameters based on American Society of Echocardiography guidelines focusing on MR mechanism, severity, and feasibility of M-TEER. Factors associated with residual MR ≤1+ were identified using logistic regression. RESULTS: In 180 randomized patients, baseline echocardiographic parameters were well matched between the PASCAL (n = 117) and MitraClip (n = 63) groups, with flail leaflets present in 79.2% of patients. Baseline MR was 4+ in 76.4% and 3+ in 23.6% of patients. All patients achieved MR ≤2+ at discharge. The proportion of patients with MR ≤1+ was similar in both groups at discharge but diverged at 6 months, favoring PASCAL (83.7% vs 71.2%). Overall, patients with a smaller flail gap were significantly more likely to achieve MR ≤1+ at discharge (adjusted OR: 0.70; 95% CI: 0.50-0.99). Patients treated with PASCAL and those with a smaller flail gap were significantly more likely to sustain MR ≤1+ to 6 months (adjusted OR: 2.72 and 0.76; 95% CI: 1.08-6.89 and 0.60-0.98, respectively). CONCLUSIONS: The study used DMR-specific echocardiographic methodology for M-TEER reflecting current guidelines and advances in 3-dimensional echocardiography. Treatment with PASCAL and a smaller flail gap were significant factors in sustaining MR ≤1+ to 6 months. Results demonstrate that MR ≤1+ is an achievable benchmark for successful M-TEER. (Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial [CLASP IID]; NCT03706833).

Urgent robotic coronary revascularization in a pregnant woman.

BACKGROUND: Outcomes of robotic-assisted coronary artery bypass grafting in pregnant women have not been assessed. OBJECTIVE: This study aimed to understand the importance of minimally invasive robotic-assisted coronary artery bypass grafting in pregnant woman with coronary artery disease. We describe the case of a G3P1011 woman at 19+6 weeks' gestation presenting with a non-ST myocardial infarction treated with off-pump hybrid robotic-assisted revascularization. STUDY DESIGN: This study describes the surgical approach for a pregnant woman presenting with non-ST myocardial infarction treated with hybrid robotic-assisted revascularization. RESULTS: A coronary angiography demonstrated a culprit lesion of 90% stenosis in the left anterior descending coronary artery and an 80% stenosis in the right coronary artery. Because of the high rate of complications with traditional coronary artery bypass grafting, the heart team opted for hybrid robotic-assisted revascularization and the postoperative recovery was uneventful. CONCLUSION: Robotic coronary artery bypass grafting can be the preferred surgical choice to decrease maternal and fetal mortality in patients undergoing coronary artery bypass grafting, and it is an important tool in the surgical armamentarium.

Percutaneous transeptal mitral valve endocarditis debulking with AngioVac aspiration system.

Vacuum assisted aspiration with the AngioVac system has been well described for; right sided endocarditis, venous thrombus, lead related infection/thrombus aspiration and right sided cardiac mass evacuation. Percutaneous transeptal debulking with AngioVac for mitral valve endocarditis (MVE) in the inoperable or high surgical risk patient has not been well defined. A significant proportion of high/prohibitive surgical risk patients with left sided infective endocarditis (IE) are not offered valve surgery as patients in the acute active phase of IE have a high surgical mortality. Nonetheless, sequala of acute IE ie stroke, sepsis or hemodynamic instability in itself is associated with high morbidity and mortality without surgical treatment. A case report of an inoperable patient with methicillin sensitive staphylococcus aureus MVE who was offered MV vegetation debulking with the AngioVac Gen3 C 180 MV system is described. Preprocedural planning with attention to; optimal transeptal height puncture, use of sentinel cerebral protection device to decrease risk of procedure related cerebral embolism and venous extracorporeal membrane cannula, rather than arterial cannula for reinfusion, is described to avoid large bore arterial access related vascular complications. Further studies in a randomized manner are warranted to test these procedural techniques and determine outcomes of percutaneous aspiration of left sided IE with the AngioVac system in this highrisk inoperable cohort of patients.

Three-Dimensional Intracardiac Echocardiography for Tricuspid Transcatheter Edge-to-Edge Repair.

Patients with severe symptomatic tricuspid regurgitation face a significant dilemma in treatment options, as the yearly mortality with medical therapy and the surgical mortality for tricuspid repair or replacement are high. Transcatheter edge-to-edge repair (TEER) for the tricuspid valve is becoming a viable option in patients, although procedural success is dependent on high-quality imaging. While transesophageal echocardiography remains the standard for tricuspid TEER procedures, intracardiac echocardiography (ICE) with three-dimensional (3D) multiplanar reconstruction (MPR) has many theoretical and practical advantages. The aim of this article was to describe the in vitro wet lab-based imaging work done to facilitate the best approach to 3D MPR ICE imaging and the procedural experience gained with 3D MPR ICE in tricuspid TEER procedures with the PASCAL device.

Pulmonary Embolus Imaging Assessment With Emphasis on Echocardiography.

BACKGROUND: This case discusses the importance of echocardiography, or transthoracic echocardiography (TTE), in detecting and diagnosing pulmonary embolisms (PE). The patient described in this case study, who underwent an echocardiography examination a few years before, had little reason to suspect the result of his PE would be a metastatic tumor showering masses of cancerous material and blood clots to his lungs. DISCUSSION: Although computed tomography angiography is the gold standard for diagnosing PE, echocardiography is the preferred modality for identifying heart masses or tumors and provides vital PE information. Four testing components provide essential information for PE detection (ie, right ventricle dysfunction, McConnell sign, elevated pulmonary artery pressures, and visualization of the mass or thrombus). Through these components, TTE has a vital role in patient care, which other imaging modalities lack. The patient in this case study is an example of why protocols should be standardized for preventive hepatocellular carcinoma screenings and sonography implemented as a routine PE detection tool. CONCLUSION: Echocardiography is noninvasive, causes no known adverse effects to the patient, presents instantaneous results, and is cost effective and time efficient. Although PE is treatable, it is a common cause of death; the use of echocardiography to diagnose PE might change that outcome.

Feasibility Study of the Transcatheter Valve Repair System for Severe Tricuspid Regurgitation.

BACKGROUND: Tricuspid regurgitation (TR) is a prevalent disease with limited treatment options. OBJECTIVES: This is the first 30-day report of the U.S. single-arm, multicenter, prospective CLASP TR early feasibility study of the PASCAL transcatheter valve repair system in the treatment of TR. METHODS: Patients with symptomatic TR despite optimal medical therapy, reviewed by the local heart team and central screening committee, were eligible for the study. Data were collected at baseline, discharge, and the 30-day follow-up and were reviewed by an independent clinical events committee and echocardiographic core laboratory. Feasibility endpoints included safety (composite major adverse event [MAE] rate), echocardiographic, clinical, and functional endpoints. RESULTS: Of the 34 patients enrolled in the study, the mean age was 76 years, 53% were women, the mean Society of Thoracic Surgeons score was 7.3%, 88% had atrial fibrillation/flutter, 97% had severe or greater TR, and 79% had New York Heart Association (NYHA) functional class III/IV symptoms. Twenty-nine patients (85%) received implants; at 30 days, 85% of them achieved a TR severity reduction of at least 1 grade, with 52% with moderate or less TR (p < 0.001). The MAE rate was 5.9%, and none of the patients experienced cardiovascular mortality, stroke, myocardial infarction, renal complication, or reintervention. Eighty-nine percent of the patients improved to NYHA functional class I/II (p < 0.001), the mean 6-min walk distance improved by 71 m (p < 0.001), and the mean Kansas City Cardiomyopathy Questionnaire score improved by 15 points (p < 0.001). CONCLUSIONS: In this early experience, the repair system performed as intended, with substantial TR reduction, favorable safety results with a low MAE rate, no mortality or reintervention, and significant improvements in functional status, exercise capacity, and quality of life. (Edwards CLASP TR EFS [CLASP TR EFS]; NCT03745313).

Imaging skills for transthoracic echocardiography in cardiology fellows: The value of motion metrics.

BACKGROUND: Proficiency in transthoracic echocardiography (TTE) requires an integration of cognitive knowledge and psychomotor skills. Whereas cognitive knowledge can be quantified, psychomotor skills are implied after repetitive task performance. We applied motion analyses to evaluate psychomotor skill acquisition during simulator-based TTE training. METHODS AND RESULTS: During the first month of their fellowship training, 16 cardiology fellows underwent a multimodal TTE training program for 4 weeks (8 sessions). The program consisted of online and live didactics as well as simulator training. Kinematic metrics (path length, time, probe accelerations) were obtained at the start and end of the course for 8 standard TTE views using a simulator. At the end of the course TTE image acquisition skills were tested on human models. After completion of the training program the trainees reported improved self-perceived comfort with TTE imaging. There was also an increase of 8.7% in post-test knowledge scores. There was a reduction in the number of probe accelerations [median decrease 49.5, 95% CI = 29-73, adjusted P < 0.01], total time [median decrease 10.6 s, 95% CI = 6.6-15.5, adjusted P < 0.01] and path length [median decrease 8.8 cm, 95% CI = 2.2-17.7, adjusted P < 0.01] from the start to the end of the course. During evaluation on human models, the trainees were able to obtain all the required TTE views without instructor assistance. CONCLUSION: Simulator-derived motion analyses can be used to objectively quantify acquisition of psychomotor skills during TTE training. Such an approach could be used to assess readiness for clinical practice of TTE.

Manual Skill Acquisition During Transesophageal Echocardiography Simulator Training of Cardiology Fellows: A Kinematic Assessment.

OBJECTIVE: To investigate whether a transesophageal echocardiography (TEE) simulator with motion analysis can be used to impart proficiency in TEE in an integrated curriculum-based model. DESIGN: A prospective cohort study. SETTING: A tertiary-care university hospital. PARTICIPANTS: TEE-naïve cardiology fellows. INTERVENTIONS: Participants underwent an 8-session multimodal TEE training program. Manual skills were assessed at the end of sessions 2 and 8 using motion analysis of the TEE simulator's probe. At the end of the course, participants performed an intraoperative TEE; their examinations were video captured, and a blinded investigator evaluated the total time and image transitions needed for each view. Results are reported as mean±standard deviation, or median (interquartile range) where appropriate. MEASUREMENTS AND MAIN RESULTS: Eleven fellows completed the knowledge and kinematic portions of the study. Five participants were excluded from the evaluation in the clinical setting because of interim exposure to TEE or having participated in a TEE rotation after the training course. An increase of 12.95% in post-test knowledge scores was observed. From the start to the end of the course, there was a significant reduction (p<0.001 for all) in the number of probe. During clinical performance evaluation, trainees were able to obtain all the required echocardiographic views unassisted but required a longer time and had more probe transitions when compared with an expert. CONCLUSION: A curriculum-based approach to TEE training for cardiology fellows can be complemented with kinematic analyses to objectify acquisition of manual skills during simulator-based training.

Quality Assessment in Dobutamine Stress Echocardiography: What are the Clinical Predictors Associated With a Non-Diagnostic Test?

BACKGROUND: Non-diagnostic dobutamine stress echocardiography (ndDSE, failure to achieve 85% of maximal predicted heart rate (HR) without evidence of inducible ischemia) is an important limitation affecting quality of DSE testing. The objectives of this study were to identify the clinical variables associated with a non-diagnostic Dobutamine Stress Echocardiogram (ndDSE) and further evaluate the patterns of subsequent testing for myocardial ischemia. METHODS: Consecutive DSE's over a 17 month period (January 2008 to June 2009) were studied. Baseline demographics, medical history, and vital signs were collected. Subsequent testing was determined for up to 6 months after the initial DSE. Univariate and multivariate logistic regression analysis was performed to identify clinical factors associated with ndDSE. RESULTS: Of 467 total DSE, 314 (67%) were negative for ischemia, 69 (15%) were positive, and 84 (18%) were ndDSE. Of those recommended for further nuclear MPI testing 12 (14%) had an ndDSE compared to 16 (4%) patients with a diagnostic DSE (P = 0.001). Fifty percent of the ndDSE nuclear MPI tests were positive for ischemia. In the univariate analysis, Diabetes Mellitus (DM; P = 0.003), calcium channel antagonist (CCA) use (P = 0.047), Hypertension (HTN; P = 0.06), low baseline HR (P < 0.001), and younger age group (P = 0.02) were predictive of ndDSE. Of these, all except CCA use remained independent predictors of ndDSE in multivariate analysis. A 4 variable model for predicting ndDSE was developed from the multivariate logistic regression displayed in Table 1 (age and baseline HR were categorized and scored 0-2; DM and HTN were scored as 0 (absent) or 1 (present)). Figure 2 demonstrates how risk of ndDSE correlated with a higher score, with each increment having an odds ratio of 2.1 (P < 0.001). CONCLUSIONS: DM, HTN, younger age, and lower baseline HR affect the quality of DSE testing, resulting in non-diagnostic tests. A model combining these factors can identify patients most likely to have this outcome. Identification of this cohort may improve referral patterns and improve the quality of stress testing.

Method for establishing authorship in a multicenter clinical trial.

With the emergence of large multicenter trials over the past 20 years, the numbers of investigators involved and publications resulting from each study have grown exponentially. An efficient, fair, and effective way to establish authorship on study-related manuscripts could diminish conflict among the investigators and help ensure robust and timely dissemination of study results. This article describes a process developed by the investigators in the HF-ACTION (Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training) trial (ClinicalTrials.gov registration number: NCT00047437) to establish authorship of the manuscripts describing the baseline characteristics, study design, and trial outcomes in an equitable and transparent manner based on objective, quantifiable contributions to the study as a whole. The HF-ACTION investigators developed a scoring system that assigned points to investigators by using the criteria established for enrollment, adherence to the exercise program, data completion, committee service, and other trial efforts. The scoring system has been successfully implemented for baseline manuscripts and has allowed many investigators to participate in the HF-ACTION publication process.

Modifiable cardiovascular risk factors among individuals in low socioeconomic communities and homeless shelters.

To understand cardiovascular health in low socioeconomic populations, we analyzed the data from 426 low socioeconomic community-dwelling males and females and 287 homeless males in Philadelphia. Despite higher prevalence of smoking and hypertension, the proportion of homeless participants at increased risk for coronary heart disease was comparable with that of low socioeconomic community-dwelling participants. Among various characteristics, emotional stress was significantly associated with coronary heart disease risk in low socioeconomic community-dwelling participants only, suggestive of a differential psychosocial effect of stress. Our findings suggest that low socioeconomic populations are heterogeneous with respect to their risk factors and needs for interventions.