Transcatheter edge-to-edge repair of the tricuspid valve: The US experience.

OBJECTIVES: To examine the trends in utilization and outcomes of tricuspid valve (TV) transcatheter edge-to-edge repair (TEER). BACKGROUND: Surgery for isolated tricuspid regurgitation is associated with high morbidity and mortality and is rarely performed. TV TEER is an attractive alternative. METHODS: The Nationwide Readmissions Database was queried using the International Classification of Diseases, 10th Revision, procedure code for TV TEER for years 2016-2019. The main outcomes were trends in utilization and in-hospital all-cause mortality. RESULTS: We identified 918 hospitalizations for TV TEER. There was an uptrend in its utilization from 13 cases in the first quarter of 2016 to 122 cases in the last quarter of 2019 (p trend < 0.001). Concomitant mitral valve (MV) TEER was performed in 42.1% of admissions. The overall in-hospital mortality was 2.1%. Surgical TV replacement was needed in 1.1% of admissions; none of them died during the index hospitalization. Unplanned rehospitalizations were common at 30 days (15.7%); 38.2% of those were due to heart failure. There was no difference in in-hospital mortality between isolated TV TEER and combined MV and TV TEER (1.7% vs. 2.6%, p = 0.359). However, admissions receiving combined procedure had lower length of stay and urgent readmission rate. CONCLUSION: The current study showed that there was an increase in the utilization of TV TEER over 2016-2019 in the United States. TV TEER was associated with low rates of in-hospital mortality; however, the rate of urgent readmission remains high, mainly due to heart failure.

Clinical Factors and Outcomes When Real-World Heart Teams Overruled STS Risk Scores in TAVR Cases.

Objectives: This study was conducted to determine why heart teams recommended transcatheter aortic valve replacement (TAVR) versus surgical AVR (SAVR) for patients at low predicted risk of mortality (PROM) and describe outcomes of these cases. Background: Historically, referral to TAVR was based predominately on the Society of Thoracic Surgeons (STS) risk model's PROM >3%. In selected cases, heart teams had latitude to overrule these scores. The clinical reasons and outcomes for these cases are unclear. Methods: Retrospective data were gathered for all TAVR and SAVR cases conducted by 9 hospitals between 2013 and 2017. Results: Cases included TAVR patients with STS PROM >3% (n = 2,711) and ≤3% (n = 415) and SAVR with STS PROM ≤3% (n = 1,438). Leading reasons for recommending TAVR in the PROM ≤3% group were frailty (57%), hostile chest (22%), severe lung disease (16%), and morbid obesity (13%), and 44% of cases had multiple reasons. Most postoperative and 30-day outcomes were similar between TAVR groups, but the STS PROM ≤3% group had a one-day shorter length of stay (2.5 ± 3.4 vs. 3.5 ± 4.7 days; p ≤ 0.001) and higher one-year survival (91.6% vs. 86.0%, p=0.002). In patients with STS PROM ≤3%, 30-day mortality was higher for TAVR versus SAVR (2.0% vs. 0.6%; p < 0.001). Conclusions: Heart teams recommended TAVR in patients with STS PROM ≤3% primarily due to frailty, hostile chest, severe lung disease, and/or morbid obesity. Similar postoperative outcomes between these patients and those with STS PROM >3% suggest that decisions to overrule STS PROM ≤3% were merited and may have reduced SAVR 30-day mortality rate.

Treatment of iliac artery bifurcation aneurysms with the second-generation straight iliac bifurcated device.

BACKGROUND: There are few long term studies to show the safety and efficacy of iliac artery aneurysm exclusion, especially in regards to the straight iliac branched device. The objective of our study was to add our data with a mean follow-up of 32 months to the existing data available. METHODS: Patients undergoing iliac bifurcation procedure either as standalone or in combination with abdominal aortic aneurysm exclusion at two vascular centers had data prospectively gathered between 2004 and 2014. Collected data was analyzed for baseline characteristics, procedural events, and clinical follow-up; variables included endoleaks, reinterventions, and internal iliac artery (IIA) closure. RESULTS: A total of 45 iliac vessels in 41 patients (36 male) with a mean age of 70.4 years were treated with the iliac branched device. Procedural success was achieved in 85% (35/41) of patients and 87% (39/45) vessels with no intraoperative death. Of the six technical failures, three occurred due to failure to place the straight iliac branched device or stent properly. Two occurred because of endoleaks at the end of the procedure, and one occurred because the IIA side-branch occluded and could not be reopened. The mean patient follow-up was 32.0 ± 27.3 months (range, 0-109 months). During this time period, the IIA patency rate on an intention-to-treat basis was 81%, and the freedom from endoleak rate on an intention-to-treat basis was 76% per patient. The freedom from reintervention per patient was 75%. No patient reported symptoms of pelvic ischemia and permanent buttock claudication. CONCLUSIONS: In this study with mean follow-up of 32 months, treatment with iliac bifurcated devices is a safe and durable option in a carefully selected population of patients with iliac artery bifurcation aneurysms.

Comparison of 26-mm Evolut and 23-mm Sapien 3 Valves in TAVR for Small Aortic Annulus.

BACKGROUND: Patients with small aortic annuli (SAA) are prone to higher post-transcatheter aortic valve replacement (TAVR) transvalvular gradients and development of prosthesis-patient mismatch (PPM). In many patients with SAA, the choice of TAVR valve commonly involves choosing between the 26-mm Medtronic Evolut 2 (ME26) or the 23-mm Edwards Sapien 3 valve (ES23). We compared echocardiographic and clinical outcomes in patients with SAA undergoing TAVR with either valve. METHODS: We queried the Providence St. Joseph Health Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry database for patients undergoing TAVR with either the ES23 or ME26 between July 2015 and December 2018 at 11 hospitals. Post-TAVR echocardiographic and clinical results in-hospital, at 1 month, and at 1 year were examined. High gradient (HG) was defined as mean gradient (MG) ≥20 mm Hg. RESULTS: We identified 1162 patients with SAA undergoing TAVR with either the ME26 (n = 233) or ES23 valve (n = 929). Baseline characteristics between groups were similar. At 1 month, the ME26 was associated with a lower MG than the ES23 (7.7 ± 4.7 mm Hg vs 13.1 ± 4.9 mm Hg; P<.001) and moderate or severe PPM (11% and 3% vs 27% and 13%; P<.001). Occurrence of HG at 1 year was lower with the ME26 valve vs the ES23 valve (0% vs 15%; P<.001). In-hospital and follow-up clinical outcomes to 1 year were similar for both groups. CONCLUSION: TAVR in SAA with the ME26 is associated with lower incidence of HG or PPM compared with the ES23. While clinical outcomes at 1 year were similar, the long-term implications of these findings remain unknown.

Transcatheter Closure of Large Atrial Septal Defects in Adults.

OBJECTIVE: To examine the outcomes of percutaneous closure of large atrial septal defects (ASDs) (≥25 mm). BACKGROUND: Data on long-term results after closure of large ASDs are limited. METHODS: We reviewed the records of 275 consecutive patients who underwent transcatheter closure of large (≥25 mm) ASDs from January 1999 until December 2016 in our center. The most common indication for closure was a large left-to-right shunt. Follow-up (FU) was performed at regular intervals thereafter. Results after closure of ASDs with diameters of 25-30 mm, >30-35 mm and >35 mm were compared. RESULTS: Percutaneous closure was technically successful in 99.6%. Mean FU time was 4.8 years (0-15.5 years). Peri-operative (30-day) adverse events occurred in 20.4% and included death in 0.7% (one unrelated to the procedure and one of unknown cause), device erosion in 0.7%, device embolization in 2.9%, pericardial effusion in 5.5%, air embolism in 0.4%, new onset atrial fibrillation in 10.5%, transient supraventricular tachycardia in 0.4% and fever in 0.7%. Late (>30 days after the procedure) atrial fibrillation occurred in 5.8%. There was one device erosion >15 years after the implantation treated successfully surgically. Complete defect closure was achieved in 95.6%. CONCLUSION: Device closure of large ASDs is feasible, safe and effective with high technical success and low risk of serious periprocedural complications. Nevertheless, in very large defects (>40 mm), both options, surgery and percutaneous closure should be considered. Device or procedural long-term adverse events are rare.