Background: Prior studies on revascularization prior to transcatheter aortic valve replacement (TAVR), in patients with significant coronary artery disease (CAD), have reported mixed results. Aim: We ...sought to perform a meta-analysis combining current evidence by investigating outcomes of revascularization in patients who undergo TAVR with coexisting CAD. Methods: We searched literature for studies reporting on outcomes following TAVR performed with versus without pre-TAVR PCI, for coexisting CAD. Random-effect model was used to pool estimates of odds ratios (ORs). Results: Twenty-four reports with 12,182 TAVR patients were included: 22 observational and 2 clinical trials. 4,110 (33.7%) were in the pre-TAVR PCI group, 51.4% were females, and mean age was 81.9 years. The 30-day mortality was 5.2% versus 5.0% in patients with versus without pre-TAVR PCI, respectively OR= 1.19 (95% CI: 0.91–1.55, P= 0.20). Pooled 1-year mortality was 18.1% versus 19.1% in patients with versus without pre-TAVR PCI (OR= 1.12, 95% CI: 0.95–1.31, P= 0.61). There was no significant difference between the groups for myocardial infarction, stroke, acute kidney injury, pacemaker implantation, or re-hospitalization. Pre-TAVR PCI was associated with an increased risk of life-threatening bleeding at 30 days. Conclusion: Pre-TAVR revascularization with PCI was not associated with improved 30-day or 1-year mortality; however, it was associated with an increased risk of life-threatening bleeding at 30-day post-TAVR. Our results do not support routine revascularization with PCI prior to TAVR with coexisting CAD. Future trials addressing anatomical complexity and symptom burden may help better risk stratify patients who may benefit from pre-TAVR revascularization.
Bicuspid aortic valve (BAV) is the most common congenital cardiac anomaly and the need for aortic valve (AV) intervention is common in these patients because of altered structural and geometric ...changes leading to altered blood flow across the valve.1 Concurrent mitral regurgitation (MR) with bicuspid aortic stenosis (AS) is common and leads to a complex interplay between hemodynamic conditions and loading conditions on the ventricle.2 Transcatheter AV implantation (TAVI) is associated with improvement of MR in >50% of patients with the degree of residual MR after TAVI associated with higher mortality.3 Although data exists on the changes in MR after TAVI, there is no dedicated data in bicuspid AS. Linear analysis showed that improvement in MR was associated with higher baseline transvalvular peak gradients (p <0.001), higher systolic blood pressure (p = 0.008), and was independent of age (p = 0.37), gender (p = 0.76), and Sievers type (p = 0.33). ...TAVI in patients with severe bicuspid AS is associated with an improvement in concomitant MR and peak left ventricular pressure that is independent of Sievers morphology.
Several mechanisms that drive coronary artery disease (CAD) and severe aortic stenosis (AS) are similar, with a substantial portion of patients referred for transcatheter aortic valve implantation ...(TAVI) in pivotal trials having a history of coronary artery bypass grafting (CABG).1 TAVI has emerged as an alternative treatment strategy to treat AS compared with surgical aortic valve replacement patients with previous CABG to avoid the need for redo sternotomy, with similar in-hospital and short-term outcomes.2,3 We aimed to evaluate intermediate-term outcomes in patients with and without a history of CABG who underwent TAVI. TAVI in patients with CABG offers an advantage to surgical aortic valve replacement in treating severe AS because of decreased need for redo sternotomy, thus avoiding associated morbidity and promoting early recovery. ...despite the overall higher Society of Thoracic Surgeon risk for valvular intervention in severe AS in patients with previous CABG, the intermediate-term mortality risk and clinical outcomes after TAVI are comparable in the 2 groups.Disclosures Dr. Golwala serves as an advisory consultant for Medtronic.
...these patients were younger and all the mortality was observed in patients classified under Child-Pugh B. The increase in mortality in this population can be attributed to the various ...manifestations of liver disease (i.e., hepatorenal syndrome, volume overload, coagulopathy, and encephalopathy). The increased risk of bleeding in patients with cirrhosis seen in our analysis is similar to previous studies and is related to bleeding diathesis/coagulopathy seen in this population, along with thrombocytopenia owing to splenic sequestration. In summary, owing to an overall increased competing risk of mortality in patients with cirrhosis, increased risks of bleeding complications related to SAVR and favorable short and intermediate-term outcomes with TAVI, TAVI may be considered as an initial choice of therapy for severe AS in patients with cirrhosis.Disclosures Dr. Golwala serves as an advisory consultant for Medtronic.
Background. Despite an association between operator volumes and procedural success, there remains an incomplete understanding of the contemporary utilization and procedural volumes for mitral valve ...transcatheter edge-to-edge repair (MTEER). We aimed to identify annual operator procedural volumes, temporal trends, and geographic variability for MTEER among Medicare patients in the United States (US). Methods. We queried the National Medicare Provider Utilization and Payment Database for a CPT code (33418) specific for MitraClip device from 2015 through 2019. We analyzed annual operator procedural volumes and incidence and identified longitudinal and geographic trends in MTEER utilization. Results. From 2015 through 2019, a total of 27,034 MTEER procedures were performed among Medicare patients in the US. The nationwide incidence increased from 6.2 per 100,000 patients in 2015 to 23.8 per 100,000 patients in 2019, a 283% increase over the study period (Ptrend < 0.001). The incidence of MTEER by state varied by nearly 900% (range 5.5 to 54.9 per 100,000 person-years). In 2019, the mean annual MTEER operator annual volume was 9.1 MTEER procedures and had grown from 6.2 per year in 2015. Conclusions. In this nationwide study of Medicare beneficiaries in the United States, we identified a significant and sustained increase in the utilization of MTEER devices and operators and growth in annual procedural volumes from 2015 through 2019 with considerable variability in utilization by state. Further studies are needed to understand the clinical impact of variability in utilization and the optimal procedural volumes to ensure high efficacy outcomes and maintain critical access to MTEER therapies.
Surgical management of isolated tricuspid regurgitation (TR) is associated with high morbidity and mortality, thereby creating a significant need for a lower-risk transcatheter solution.
The ...single-arm, multicenter, prospective CLASP TR (Edwards PASCAL TrAnScatheter Valve RePair System in Tricuspid Regurgitation CLASP TR Early Feasibility Study) evaluated 1-year outcomes of the PASCAL transcatheter valve repair system (Edwards Lifesciences) to treat TR.
Study inclusion required a previous diagnosis of severe or greater TR and persistent symptoms despite medical treatment. An independent core laboratory evaluated echocardiographic results, and a clinical events committee adjudicated major adverse events. The study evaluated primary safety and performance outcomes, with echocardiographic, clinical, and functional endpoints. Study investigators report 1-year all-cause mortality and heart failure hospitalization rates.
Sixty-five patients were enrolled: mean age of 77.4 years; 55.4% female; and 97.0% with severe to torrential TR. At 30 days, cardiovascular mortality was 3.1%, the stroke rate was 1.5%, and no device-related reinterventions were reported. Between 30 days and 1 year, there were an additional 3 cardiovascular deaths (4.8%), 2 strokes (3.2%), and 1 unplanned or emergency reintervention (1.6%). One-year postprocedure, TR severity significantly reduced (P < 0.001), with 31 of 36 (86.0%) patients achieving moderate or less TR; 100% had at least 1 TR grade reduction. Freedom from all-cause mortality and heart failure hospitalization by Kaplan-Meier analyses were 87.9% and 78.5%, respectively. Their New York Heart Association functional class significantly improved (P < 0.001) with 92% in class I or II, 6-minute walk distance increased by 94 m (P = 0.014), and overall Kansas City Cardiomyopathy Questionnaire scores improved by 18 points (P < 0.001).
The PASCAL system demonstrated low complication and high survival rates, with significant and sustained improvements in TR, functional status, and quality of life at 1 year. (Edwards PASCAL TrAnScatheter Valve RePair System in Tricuspid Regurgitation CLASP TR Early Feasibility Study CLASP TR EFS; NCT03745313)
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The association, if any, between the effective regurgitant orifice area (EROA) to left ventricular end-diastolic volume (LVEDV) ratio and 1-year mortality is controversial in patients who undergo ...mitral transcatheter edge-to-edge repair (m-TEER) with the MitraClip system (Abbott Vascular, Santa Clara, CA). This study's objective was to determine the association between EROA/LVEDV and 1-year mortality in patients who undergo m-TEER with MitraClip. In patients with severe secondary (functional) mitral regurgitation (MR), we analyzed registry data from 11 centers using generalized linear models with the generalized estimating equations approach. We studied 525 patients with secondary MR who underwent m-TEER. Most patients were male (63%) and were New York Heart Association class III (61%) or IV (21%). Mitral regurgitation was caused by ischemic cardiomyopathy in 51% of patients. EROA/LVEDV values varied widely, with median = 0.19 mm
/ml, interquartile range 0.12,0.28 mm
/ml, and 187 patients (36%) had values <0.15 mm
/ml. Postprocedural mitral regurgitation severity was substantially alleviated, being 1+ or less in 74%, 2+ in 20%, 3+ in 4%, and 4+ in 2%; 1-year mortality was 22%. After adjustment for confounders, the logarithmic transformation (Ln) of EROA/LVEDV was associated with 1-year mortality (odds ratio 0.600, 95% confidence interval 0.386 to 0.933, p = 0.023). A higher Society of Thoracic Surgeons risk score was also associated with increased mortality. In conclusion, lower values of Ln(EROA/LVEDV) were associated with increased 1-year mortality in this multicenter registry. The slope of the association is steep at low values but gradually flattens as Ln(EROA/LVEDV) increases.
Risk factors for adverse clinical outcomes in patients with moderate aortic stenosis are not well defined. Previous studies have suggested that certain patients with moderate AS may be at an ...increased risk of heart failure (HF) or death. All patients with moderate AS seen in our institution during the study period (6/1/2014 to 6/30/2017) with a minimum 1-year follow-up were included. Clinical and echocardiographic data were collected retrospectively. End points were defined as HF hospitalization, aortic valve replacement (AVR), or death. Kaplan-Meier and multivariable Cox proportional hazard models analyses were conducted using composite outcomes of (1) HF hospitalization or AVR and (2) HF hospitalization, AVR, or all-cause death. A total of 151 subjects met the inclusion criteria. The most significant risk factors associated with the composite outcomes were an ejection fraction (EF) <50% ((1) hazard ratio HR: 4.1; 95% confidence interval CI: 2.34, 7.12; (2) HR: 3.8; 95% CI: 2.2, 6.6), atrial fibrillation ((1) HR: 2.0; 95% CI: 1.2, 3.2; (2) HR: 2.1; 95% CI: 1.43, 3.2), left ventricular hypertrophy ((1) HR: 5.85; 95% CI: 2.0, 15.8; (2) HR: 3.2; 95% CI: 1.4, 7.4), aortic valve area ((1) HR: 0.3; 95% CI: 0.1, 0.6; (2) HR: 0.32; 95% CI: 0.1, 0.65), and abnormal right ventricular function ((1) HR: 4.3; 95% CI: 2.5, 7.5; (2) HR: 5.5; 95% CI: 3.0, 9.8). In conclusion, presence of reduced ejection fraction, atrial fibrillation, left ventricular hypertrophy, and abnormal right ventricular function are associated with an increased risk of HF hospitalization, AVR, and death in patients with moderate aortic stenosis.
