Association of Relative Left Ventricular Outflow Tract Area and Transcatheter Aortic Valve Replacement Related Paravalvular Leak.

Background: Post-transcatheter aortic valve replacement (TAVR), paravalvular leak (PVL) is a quality metric associated with worse clinical outcomes. Transcatheter heart valve (THV) sizing is based primarily on the systolic annular size without regard to the left ventricular outflow tract (LVOT), which also lies within the THV landing zone. We hypothesized that LVOT size relative to the annulus is associated with post-TAVR PVL. Methods: Data from consecutive patients undergoing TAVR in a single high-volume center from January 2018 to March 2019 were used. Pre-TAVR data from multidetector computed tomography (MDCT) were collected. Relative LVOT area was defined as LVOT area/annular area during systole. Logistic regression analysis was used to evaluate association with post-TAVR mild or greater PVL by transthoracic echocardiography before discharge. Results: Among 293 patients (median age, 81.1 years; female, 49.5%; White, 88.0%), 81.6% received SAPIEN 3 and 18.4% received CoreValve THV models. Aortic valve morphology was bicuspid in 10.9% of patients. Prevalence of mild or greater PVL was 23.5% (mild in 20.1%). Relative LVOT area had a significant inverse association such that the odds of mild or greater PVL decreased significantly with every 1% increase in relative LVOT area (adjusted odds ratio, 0.96; 95% CI, 0.93-0.98; P = .002). There was no interaction between the type of implanted valve and the relative LVOT area. Patients in the highest relative LVOT tertile had significantly lower odds of mild or greater PVL (adjusted odds ratio, 0.42; 95% CI, 0.21-0.87; P = .018 vs first tertile). Conclusions: In patients undergoing TAVR with the newer generation of THV (SAPIEN 3 and CoreValve models), a relatively narrower LVOT area vs annular area was independently associated with increased odds of mild or greater PVL before discharge.

Changes in Left Ventricular Function and Outcomes After Trancatheter Edge-to-Edge Repair for Secondary Mitral Regurgitation.

Background: Transcatheter edge-to-edge repair (TEER) improved outcomes in patients with heart failure (HF) and severe secondary mitral regurgitation (SMR) compared with guideline-directed medical therapy (GDMT) alone regardless of the severity of baseline left ventricular ejection fraction (LVEF). The study aimed to evaluate the effect of early changes in LVEF after TEER and GDMT alone in patients with HF and severe SMR. Methods: Within the COAPT trial, we evaluated outcomes according to changes in LVEF from baseline to 30 days. The primary outcome was all-cause death or HF hospitalization (HFH) between 30 days and 2 years. Results: Among 432 patients with paired echocardiographic data, 182 (42.1%) had increased LVEF (LVEF change 6.0% ± 4.9%) and 250 (57.9%) had a decrease or no change in LVEF (LVEF change -6.6% ± 5.6%) from baseline to 30 days. LVEF at 30 days increased more frequently with GDMT alone compared with TEER plus GDMT (51.4% vs 33.0%; P = .0001). Between 30 days and 2 years, there were no significant differences in death or HFH in the increase LVEF and the decrease LVEF groups (58.8% vs 51.4%; multivariable-adjusted HR, 0.97; 95% CI, 0.87-1.08; P = .59). TEER plus GDMT reduced the 30-day to 2-year rate of death or HFH compared with GDMT alone consistently in patients with increase LVEF and decrease LVEF (Pint = 0.75). Conclusions: Among patients with HF and severe SMR, early improvements in LVEF were more frequent with GDMT alone compared with TEER plus GDMT but were not associated with subsequent outcomes at 2 years. TEER reduced death or HFH during 2-year follow-up irrespective of early LVEF changes.

Antithrombotic Therapy in Patients Undergoing Transcatheter Aortic Valve Implantation.

Transcatheter aortic valve implantation (TAVI) now represents the mainstay of treatment for severe aortic stenosis. Owing to its exceptional procedural efficacy and safety, TAVI has been extended to include patients at lower surgical risk, thus now encompassing a diverse patient population receiving this treatment. Yet, long-term outcomes also depend on optimal medical therapy for secondary vascular prevention, with antithrombotic therapy serving as the cornerstone. Leveraging data from multiple randomized controlled trials, the current guidelines generally recommend single antithrombotic therapy, with either single antiplatelet therapy (SAPT) or oral anticoagulation (OAC) alone in those patients without or with atrial fibrillation, respectively. Yet, individualization of this pattern, as well as specific case uses, may be needed based on individual patient characteristics and concurrent procedures. This review aims to discuss the evidence supporting antithrombotic treatments in patients treated with TAVI, indications for a standardized treatment, as well as specific considerations for an individualized approach to treatment.

Change in left ventricular function and outcomes following high-risk percutaneous coronary intervention with Impella-guided hemodynamic support.

Introduction: High-risk percutaneous coronary interventions (HRPCI) are a potential treatment option for patients with reduced left ventricular ejection fraction (LVEF) and coronary artery disease. The extent to which such intervention is coupled with improvement in LVEF and associated with favorable outcomes is unknown. Methods: We aimed to characterize the incidence and correlates of LVEF improvement after Impella-guided HRPCI, and compare clinical outcomes in patients with versus without LVEF improvement. Data on consecutive patients undergoing Impella-guided HRPCI from a single center registry were analyzed. LVEF-improvement was defined as an absolute increase of LVEF of ≥10% measured at ≥30-days after intervention. The primary outcome was a composite of all-cause death, myocardial infarction or target vessel revascularization within 1-year. Results: Out of 161 consecutive patients undergoing Impella-guided HRPCI from June 2008 to December 2017, 43% (n = 70) demonstrated LVEF-improvement (baseline LVEF of 25.09 ± 6.19 to 33.30 ± 11.98 post intervention). Patients without LVEF-improvement had higher frequency of previous MI (61.5% vs. 37.1%, p = 0.0021), Q-waves on ECG (17.6% vs. 5.7%, p = 0.024) and higher SYNTAX scores (30.8 ± 17.6 vs. 25.2 ± 12.2; p = 0.043). After correction of these confounders by multivariable analysis, no significant differences were found regarding the composite endpoint in patients with versus without LVEF-improvement (34.9% vs. 38.3%; p = 0.48). Discussion: In this single-center retrospective analysis, we report the following findings. First, LVEF improvement of at least 10% was documented in over 40% of patients undergoing Impella supported high-risk PCI. Second, a history of MI, Q-waves on admission ECG, and higher baseline SYNTAX scores were independent correlates of no LVEF improvement. Third, one year rates of adverse CV events were substantial and did not vary by the presence or absence of LVEF improvement Prospective studies with longer follow-up are needed to elucidate the impact of LVEF improvement on clinical outcomes.

Efficacy and safety of TAVR versus SAVR in patients with small aortic annuli: A systematic review and meta-analysis.

INTRODUCTION: Patients with a small aortic annulus (SAA) undergoing aortic valve replacement are at increased risk of patient-prosthesis mismatch (PPM), which adversely affects outcomes. Transcatheter aortic valve replacement (TAVR) has shown promise in mitigating PPM compared to surgical aortic valve replacement (SAVR). METHODS: We conducted a systematic review and meta-analysis following PRISMA guidelines to compare clinical outcomes, mortality, and PPM between SAA patients undergoing TAVR and SAVR. Eligible studies were identified through comprehensive literature searches and assessed for quality and relevance. RESULTS: Nine studies with a total of 2476 patients were included. There was no significant difference in 30-day Mortality between TAVR vs SAVR groups (OR = 0.65, 95% CI [ 0.09-4.61], P = 0.22). There was no difference between both groups regarding myocardial infarction at 30 days (OR = 0.63, 95% CI [0.1-3.89], P = 0.62). TAVR was associated with a significantly lower 30-day major bleeding and 2-year major bleeding, Pooled studies were homogeneous (OR = 0.44, 95% CI [0.31-0.64], P < 0.01, I2 = 0, P = 0.89), (OR = 0.4 ,95% CI [0.21-0.77], P = 0.03, I2 = 0%, P = 0.62) respectively. TAVR was associated with a lower rate of moderate PPM (OR = 0.6, 95% CI [ 0.44-0.84], p value = 0.01, i2 = 0%, p value = 0.44). The overall effect estimate did not favor any of the two groups regarding short-term Mild AR (OR = 5.44, 95% CI [1.02-28.91], P = 0.05) and Moderate/severe AR (OR = 4.08, 95% CI [ 0.79-21.02], P = 0.08, I2 = 0%, P = 0.59). CONCLUSION: Our findings suggest that both TAVR and SAVR are viable options for treating AS in patients with a small aortic annulus. TAVR offers advantages in reducing PPM and major bleeding, while SAVR performs better in terms of pacemaker implantation. Future studies should focus on comparing newer generation TAVR techniques and devices with SAVR. Consideration of patient characteristics is crucial in selecting the optimal treatment approach for AS.

Outcomes Following Percutaneous Coronary Intervention in Patients With Multivessel Disease Who Were Recommended for But Declined Coronary Artery Bypass Graft Surgery.

BACKGROUND: Patients may prefer percutaneous coronary intervention (PCI) over coronary artery bypass graft (CABG) surgery, despite heart team recommendations. The outcomes in such patients have not been examined. We sought to examine the results of PCI in patients who were recommended for but declined CABG. METHODS AND RESULTS: Consecutive patients with stable ischemic heart disease and unprotected left main or 3-vessel disease or Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery score >22 who underwent PCI after heart team review between 2013 and 2020 were included. Patients were categorized into 3 groups according to heart team recommendations on the basis of appropriate use criteria: (1) PCI-recommended; (2) CABG-eligible but refused CABG (CABG-refusal); and (3) CABG-ineligible. The primary end point was the composite of death, myocardial infarction, or stroke at 1 year. The study included 3687 patients undergoing PCI (PCI-recommended, n=1718 [46.6%]), CABG-refusal (n=1595 [43.3%]), and CABG-ineligible (n=374 [10.1%]). Clinical and procedural risk increased across the 3 groups, with the highest comorbidity burden in CABG-ineligible patients. Composite events within 1 year after PCI occurred in 55 (4.1%), 91 (7.0%), and 41 (14.8%) of patients in the PCI-recommended, CABG-refusal, and CABG-ineligible groups, respectively. After multivariable adjustment, the risk of the primary composite outcome was significantly higher in the CABG-refusal (hazard ratio [HR], 1.67 [95% CI, 1.08-3.56]; P=0.02) and CABG-ineligible patients (HR, 3.26 [95% CI, 1.28-3.65]; P=0.004) groups compared with the reference PCI-recommended group, driven by increased death and stroke. CONCLUSIONS: Cardiovascular event rates after PCI were significantly higher in patients with multivessel disease who declined or were ineligible for CABG. Our findings provide real-world data to inform shared decision-making discussions.

Feasibility and technicality of aortic valve lithotripsy-facilitate balloon valvuloplasty in patients with severe aortic stenosis unsuitable for immediate valvular replacement.

BACKGROUND: Aortic valve lithotripsy can fragment aortic valve calcium deposits and potentially restore leaflet pliability in animal model and ex-vivo, but clinical data is limited. Transcatheter aortic valve implantation (TAVR) might not be feasible as an urgent procedure in critically ill patients. Balloon valvuloplasty has the major limitation of valve recoil and inducing aortic regurgitation. AIMS: To determine the clinical feasibility of aortic valve lithotripsy-facilitated balloon valvuloplasty in patients with severe aortic stenosis unsuitable for valvular replacement. METHODS: We performed lithotripsy as adjunctive therapy to balloon aortic valvuloplasty in ten consecutive patients, most of whom were deemed unfit for TAVR. Lithotripsy of the aortic valve was performed with simultaneous inflation of one to three peripheral lithotripsy balloons to deliver ultrasound pulses. Rapid pacing was not used during lithotripsy. Aortic valve velocity, gradient, and valve area were measured before and after the procedure by echocardiogram. Transvalvular pressure gradient was recorded intra-procedurally. Periprocedural and ninety-day clinical outcomes were followed. RESULTS: Procedure was technically successful in 9 out of 10 patients and aborted in one patient due to cardiogenic shock. One patient had femoral closure device related complication. There was a statistically significant decrease in valvular gradient and increase in aortic valve area. 9 out of 10 patients recovered from acute episode and were discharged. 6 patients had improvement in NYHA class. 4 patients were subsequently able to receive TAVR. 90-day mortality occurred in 3 patients. There was no stroke or bradyarrhythmia peri-procedurally and no heart failure hospitalization at 90 days. CONCLUSION: Aortic valve lithotripsy-facilitated balloon valvuloplasty has reasonable feasibility, safety and technical reproducibility and acute clinical result. Hemodynamic effect is similar to that of balloon valvuloplasty reported in the literature. Subsequent Prognosis is not altered in critically ill patients.

Impact of diabetes mellitus on clinical outcomes after first episode in-stent restenosis PCI: Results from a large registry.

BACKGROUND: Diabetes mellitus (DM) is associated with a high rate of major adverse cardiac events (MACE) after de novo coronary artery percutaneous coronary intervention (PCI). Whether patients with DM undergoing PCI for in-stent restenosis (ISR) experience a similar heightened risk of MACE is not known. Hence, we sought to compare the clinical outcomes of patients with and without DM undergoing PCI for ISR. METHODS: Patients undergoing first episode ISR PCI between January 2015 and December 2021 were included. The primary outcome of interest was MACE (all-cause death, myocardial infarction [MI], and target lesion revascularization [TVR]) at 1-year. RESULTS: A total of 3156 patients (56.7% with DM) underwent PCI for ISR during the study period. Patients with DM were younger, more likely to be female, and had a higher prevalence of comorbidities. At 1-year follow-up, DM was associated with a higher rate of MACE (22.4% vs. 18.7%, unadjusted HR 2.03, 95%CI(1.27-3.25), p = 0.003). All-cause mortality and MI were significantly more frequent among people with DM at 1-year follow-up. The rate of TVR was similar in both groups (17.9% vs. 16.0%, unadjusted HR 1.14, 95%CI (0.94-1.37), p = 0.180). On adjusted analysis, there was no significant difference in the rate of MACE (AHR 1.07, 95%CI(0.90 - -1.29), p = 0.444), all-cause death (AHR 1.54, 95%CI(0.93-2.54), p = 0.095) or MI (AHR 1.10, 95%CI(0.74-1.63), p = 0.652). CONCLUSION: ISR PCI in patients with DM was associated with a higher rate of MACE at 1-year follow-up. However, this increased risk was no longer significant after adjusting for baseline characteristics.

Prospective Study of Risk Factors for Postoperative Atrial Fibrillation After Cardiac Surgery.

INTRODUCTION: To examine risk factors for new-onset postoperative atrial fibrillation (POAF) after cardiac surgery. METHODS: Patients enrolled in the Cardiothoracic Surgical Trials Network multicenter, randomized trial of rate control versus rhythm control for POAF were included. Predictors of POAF were determined using multivariable logistic regression. RESULTS: Among the 2104 patients who were enrolled preoperatively, 695 developed POAF (33.0%). Rates of POAF were 28.1% after isolated coronary artery bypass grafting (CABG), 33.7% after isolated valve repair or replacement, and 47.3% after CABG plus valve repair or replacement. Baseline characteristics associated with an increased risk of POAF identified on multivariable analysis included older age (odds ratio [OR] 1.57; 95% confidence interval [CI] 1.42-1.73, per 10 y), White race or non-Hispanic ethnicity (OR 1.52; CI: 1.11-2.07), history of heart failure (OR 1.55; CI: 1.16-2.08), and history of hypothyroidism (OR 1.42; CI 1.04-1.94). The type of cardiac procedure was associated with an increased risk of POAF with both isolated valve repair or replacement (OR 1.33, CI 1.08-1.64) and combined CABG plus valve repair or replacement (OR 1.64, CI 1.24-2.17) having increased risk of POAF compared to isolated CABG. No preoperative cardiac medication was associated with POAF. CONCLUSIONS: In this prospective cohort of patients, older age, a history of hypothyroidism, a history of heart failure, and valve repair or replacement, with or without CABG, and White non-Hispanic race were associated with an increased risk of POAF.

Gender-Based Differences in Outcomes After Percutaneous Coronary Intervention of Chronic Total Occlusions (Insights from a Large Single-Center Registry).

Patients who undergo percutaneous coronary intervention (PCI) of chronic total occlusions (CTO) are at a high risk for both periprocedural and post-procedural adverse events. Whether gender-differences in outcomes exist after PCI of CTO remain unclear. Therefore, we sought to investigate gender-based differences in outcomes after CTO-PCI. All patients who underwent elective CTO intervention from January 2012 to December 2017 at The Mount Sinai Hospital (New York, New York) were included. The primary end point of interest was major adverse cardiac events defined as the composite of death, myocardial infarction, and target vessel revascularization at 1 year of follow-up. A total 1,897 patients were included, of which 368 were women (19.4%). Mean follow-up time was 174 days. Women were older (66.8 ± 11.3 years vs 62.6 ± 10.9 years) and had a higher prevalence of co-morbidities including diabetes and chronic kidney disease. There were no significant differences in the rate of successful CTO-PCI between groups (73.5% vs 73.2%, p = 0.91). Women had higher rates of procedure-related complications including increased risk of post-procedural bleeding (4.1% vs 1.8%, p = 0.009) and acute vessel closure (1.36% vs 0.2%, p = 0.009). In multivariable-adjusted analysis, female gender was associated with higher risk of major adverse cardiac event and target vessel revascularization at 1 year. In conclusion, in this large single-center study, women who underwent percutaneous CTO revascularization experienced higher rates of periprocedural complications and worse clinical outcomes at 1 year compared with men. Further research is needed to address disparities in gender-specific outcomes of CTO-PCI.