Use and performance of the evolut FX transcatheter aortic valve system.

BACKGROUND: The next generation supra-annular, self-expanding Evolut FX transcatheter aortic valve (TAV) system was designed to improve catheter deliverability, provide stable and symmetric valve deployment, and assess commissural alignment during the procedure. The impact of these modifications has not been clinically evaluated. METHODS: Procedural information was collected by survey in 2 Stages: Stage I comprised 23 centers with extensive experience with Evolut TAV systems, and Stage II comprised an additional 46 centers with a broad range of balloon- and self-expanding system experience. Operators were to compare the experience with the Evolut FX to the predicate Evolut PRO+ system. RESULTS: There were 285 cases during Stage I from June 24 to August 12, 2022, and 254 cases during Stage II from August 15 to September 11, 2022. Overall, the cusp overlap technique was used in 88.6 %, and commissural alignment was achieved in 96.1 % of these cases. Compared to implanter's previous experience with the Evolut PRO+ system, less resistance was noted with the Evolut FX system: in 83.0 % of cases during vascular insertion, in 84.7 % of cases while tracking through the vasculature, in 84.4 % of cases while traversing over the arch, and 76.1 % of cases in advancing across the valve. Better symmetry of valve depth was observed in 423 of 525 cases (80.6 %). CONCLUSION: Evolut FX system design modifications translated into improvements in catheter deliverability, deployment symmetry and stability, and commissural alignment as assessed by experienced self-expanding and balloon expandable operators.

Sustained Mechanical Aspiration Thrombectomy for High Thrombus Burden Coronary Vessel Occlusion: The Multicenter CHEETAH Study.

BACKGROUND: Poor myocardial reperfusion due to distal embolization and microvascular obstruction after percutaneous coronary intervention is associated with increased risk of morbidity and mortality. Prior trials have not shown a clear benefit of routine manual aspiration thrombectomy. Sustained mechanical aspiration may mitigate this risk and improve outcomes. The objective of this study is to evaluate sustained mechanical aspiration thrombectomy before percutaneous coronary intervention in high thrombus burden acute coronary syndrome patients. METHODS: This prospective study evaluated the Indigo CAT RX Aspiration System (Penumbra Inc, Alameda CA) for sustained mechanical aspiration thrombectomy before percutaneous coronary intervention at 25 hospitals across the USA. Adults presenting within 12 hours of symptom onset with high thrombus burden and target lesion(s) located in a native coronary artery were eligible. The primary end point was a composite of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or new or worsening New York Heart Association class IV heart failure within 30 days. Secondary end points included Thrombolysis in Myocardial Infarction thrombus grade, Thrombolysis in Myocardial Infarction flow, myocardial blush grade, stroke, and device-related serious adverse events. RESULTS: From August 2019 through December 2020, a total of 400 patients were enrolled (mean age 60.4 years, 76.25% male). The primary composite end point rate was 3.60% (14/389 [95% CI, 2.0-6.0%]). Rate of stroke within 30 days was 0.77%. Final rates of Thrombolysis in Myocardial Infarction thrombus grade 0, Thrombolysis in Myocardial Infarction flow 3, and myocardial blush grade 3 were 99.50%, 97.50%, and 99.75%, respectively. No device-related serious adverse events occurred. CONCLUSIONS: Sustained mechanical aspiration before percutaneous coronary intervention in high thrombus burden acute coronary syndrome patients was safe and was associated with high rates of thrombus removal, flow restoration, and normal myocardial perfusion on final angiography.

Safety and efficacy of Everolimus-Eluting bioabsorbable Polymer-Coated stent in patients with long coronary lesions: The EVOLVE 48 study.

OBJECTIVES: The EVOLVE 48 study evaluated the safety and effectiveness of the SYNERGY 48 mm stent for the treatment of long lesions. BACKGROUND: Clinical evidence supporting the use of very long stents during percutaneous coronary intervention (PCI) is limited. The bioabsorbable polymer SYNERGY stent has shown good long-term data in a broad population of patients undergoing PCI. METHODS: Patients with lesion length >34- ≤44 mm and reference vessel diameter (RVD) ≥2.5- ≤ 4.0 mm were enrolled in this prospective, multicenter, single-arm study. The primary endpoint was 12-month target lesion failure (TLF; composite of target lesion revascularization [TLR], target-vessel myocardial infarction [TV-MI], or cardiac death) compared to a prespecified performance goal (PG). RESULTS: A total of 100 patients with mean lesion length of 35.34 ± 7.15 mm (26 patients with lesion length > 40 mm) and mean RVD 2.72 ± 0.44 mm were enrolled. Moderate to severe calcification was present in 30% of the patients and 89% had pre-TIMI flow grade 3. The rates of technical and clinical procedural success were 100%. One-year TLF was observed in 4.1% patients compared to a prespecified PG of 19.5% (95% upper confidence bound = 9.1%; p < 0.0001). Cardiac death and TLR were each observed in one patient, and TV-MI in two patients treated with SYNERGY 48 mm stent. Between the 1-2-year timeframe, TV-MI occurred in one additional patient. None of the patients experienced a definite or probable stent thrombosis through 2 years. CONCLUSIONS: PCI of long coronary lesions with the 48 mm SYNERGY stent demonstrated good procedural and clinical outcomes through 2 years, supporting its clinical safety and efficacy.

Impact of long-axis function on cardiac surgical outcomes in patients with radiation-associated heart disease.

BACKGROUND: Malignancy-associated thoracic radiation leads to radiation-associated cardiac disease (RACD) that often necessitates cardiac surgery. Myocardial dysfunction is common in patients with RACD. We sought to determine the predictive value of global left ventricular ejection fraction and long-axis function left ventricular global longitudinal strain (LV-GLS) in such patients. METHODS: We studied 163 patients (age, 63 ± 14 years; 74% women) who had RACD and underwent cardiac surgery (20% had reoperations) between 2000 and 2003. In addition to standard echocardiography, LV-GLS (%) was derived from the average of 18 segments in 3 apical views of the left ventricle, using velocity vector imaging. Standard clinical and demographic parameters were recorded. All-cause mortality was recorded. RESULTS: The mean duration between cardiac surgery and the last chest radiation was 18 ± 12 years. The median European System for Cardiac Operative Risk Evaluation (EuroSCORE) was 8, and 88 patients died over 6.6 ± 4 years. A total of 52% of patients had ≥ II+ mitral regurgitation; 23% of patients had severe aortic stenosis; and 39% of patients had ≥ II+ tricuspid regurgitation. The mean left ventricular ejection fraction was 54% ± 13%, and the mean LV-GLS was -12.9% ± 4%. In a Cox proportional survival analysis, lower LV-GLS was predictive of mortality in univariable analysis (hazard ratio, 1.07 (95% confidence interval, 1.01-1.14); P = .006); however, after adjustment for other variables, the association became nonsignificant. In patients with a EuroSCORE

Increased aorto-mitral curtain thickness independently predicts mortality in patients with radiation-associated cardiac disease undergoing cardiac surgery.

BACKGROUND: Thoracic radiation leads to radiation-associated cardiac disease (RACD), associated with substantial cardiac morbidity and mortality, often requiring complex cardiothoracic surgery. In patients with RACD, along with valvular lesions, the aorto-mitral curtain (AMC, junction between base of anterior mitral leaflet and aortic root) thickness is increased on transthoracic echocardiography. We sought to identify clinical and transthoracic echocardiography predictors of long-term mortality in patients with RACD. METHODS: We studied 173 patients with RACD (75% women, 63±14 years, 53% with breast cancer, 27% with Hodgkin lymphoma; mean time from radiation, 18±12 years), who underwent cardiothoracic surgery (26% redo) between 2000 and 2003. Clinical, transthoracic echocardiography (along with AMC), and surgical variables were recorded. Preoperative EuroSCORE and all-cause mortality were recorded. RESULTS: Mean left ventricular ejection fraction, right systolic ventricular pressure, and AMC thickness were 0.49±0.13, 41±15 mm Hg, and 0.54±0.2 cm, respectively. Fifty-one percent of patients had II+ mitral regurgitation or greater, 29% patients had II+ aortic regurgitation or greater, 23% patients had severe aortic stenosis, and 34% patients had II+ tricuspid regurgitation or greater. In 7.6±3 years of follow-up, there were 95 (55%) deaths, with a 30-day mortality rate of only 7 (4%). Absence of ß-blockers (hazard ratio, 0.49; 95% confidence interval, 0.31 to 0.79), aspirin (hazard ratio, 0.53; 95% confidence interval, 0.33 to 0.84), higher EuroSCORE (hazard ratio, 1.11; 95% confidence interval, 1.02 to 1.21), and greater AMC thickness (hazard ratio, 5.75; 95% confidence interval, 1.57 to 21.03; all p<0.01) independently predicted mortality. Aorto-mitral curtain thickness of at least 0.6 cm was associated with significantly increased mortality. CONCLUSIONS: Patients with RACD undergoing cardiothoracic surgery have high long-term mortality, which is independently predicted by AMC thickness, a higher preoperative risk score, and lack of cardioprotective medications.

Pulmonary fibrosis on multidetector computed tomography and mortality in patients with radiation-associated cardiac disease undergoing cardiac surgery.

OBJECTIVE: In the long-term, malignancy-associated thoracic radiation leads to varying degrees of pulmonary fibrosis and radiation-associated cardiac disease, often requiring cardiothoracic surgery. We sought to determine whether pulmonary fibrosis affects mortality in patients with radiation-associated cardiac disease undergoing cardiothoracic surgery. METHODS: We studied 117 patients (aged 63 ± 15 years, 71% were women) with radiation-associated cardiac disease receiving multimodality imaging who underwent cardiothoracic surgery (21% redo) between 2000 and 2003. Some 50% of patients had breast cancer, 28% of patients had Hodgkin's lymphoma, 9% of patients had lung cancer, and 13% of patients had other cancers. Time from radiation was 18 ± 12 years. Clinical, pulmonary function, angiographic, and echocardiographic parameters were recorded. On multidetector chest computed tomography, ascending aortic calcification and degree of pulmonary fibrosis (in 5 lobes for a score of 15: 0 = none, 1 = linear streaks, 2 = moderate fibrosis, and 3 = severe fibrosis with traction bronchiectasis) were recorded. RESULTS: Mean European System for Cardiac Operative Risk Evaluation was 7.9 ± 3, and forced expiratory volume at 1 minute/forced vital capacity ratio was 0.75 ± 0.2. Mean left ventricular ejection fraction was 49% ± 12%, and right systolic ventricular pressure was 42 ± 5 mm Hg. Some 27% of patients had severe aortic stenosis, and 46% of patients had II+ or greater mitral regurgitation. On multidetector chest computed tomography, mean pulmonary fibrosis score was 3.5 ± 3, and 59% of patients had ascending aortic calcification. Isolated coronary artery bypass was performed in 17% of patients; the rest were combination surgeries. At 6.3 ± 0.4 years, there were 59 deaths (50%) (3% died 1 month postoperatively). Forty-five patients (39%) had pulmonary complications in follow-up. Increasing pulmonary fibrosis score (hazard ratio, 1.11; 95% confidence interval, 1.02-1.20; P = .02), worse European System for Cardiac Operative Risk Evaluation (hazard ratio, 1.10; 95% confidence interval, 1.01-1.21; P = .04), and lack of beta-blocker (hazard ratio, 0.54; 95% confidence interval, 0.31-0.94, P = .008) and aspirin (hazard ratio, 0.54; 95% confidence interval, 0.31-0.94; P = .03) independently predicted mortality. CONCLUSIONS: In patients with radiation-associated cardiac disease undergoing cardiothoracic surgery, worsening pulmonary fibrosis is associated with increased mortality.

Long-term survival of patients with radiation heart disease undergoing cardiac surgery: a cohort study.

BACKGROUND: Thoracic radiation results in radiation-associated heart disease (RAHD), often requiring cardiothoracic surgery (CTS). We sought to measure long-term survival in RAHD patients undergoing CTS, to compare them with a matched control population undergoing similar surgical procedures, and to identify potential predictors of long-term survival. METHODS AND RESULTS: In this retrospective observational cohort study of patients undergoing CTS, matched on the basis of age, sex, and type/time of CTS, 173 RAHD patients (75% women; age, 63±14 years) and 305 comparison patients (74% women; age, 63±4 years) were included. The vast majority of RAHD patients had prior breast cancer (53%) and Hodgkin lymphoma (27%), and the mean time from radiation was 18±12 years. Clinical and surgical parameters were recorded. The preoperative EuroSCORE and all-cause mortality were recorded. The mean EuroSCOREs were similar in the RAHD and comparison groups (7.8±3 versus 7.4±3, respectively; P=0.1). Proximal coronary artery disease was higher in patients with RAHD versus the comparison patients (45% versus 38%; P=0.09), whereas redo CTS was lower in the RACD versus the comparison group (20% versus 29%; P=0.02). About two thirds of patients in either group had combination surgical procedures. During a mean follow-up of 7.6±3 years, a significantly higher proportion of patients died in the RAHD group than in the comparison group (55% versus 28%; P<0.001). On multivariable Cox proportional hazard analysis, RAHD (2.47; 95% confidence interval, 1.82-3.36), increasing EuroSCORE (1.22; 95% confidence interval, 1.16-1.29), and lack of ß-blockers (0.66; 95% confidence interval, 0.47-0.93) were associated with increased mortality (all P<0.01). CONCLUSIONS: In patients undergoing CTS, RAHD portends increased long-term mortality. Alternative treatment strategies may be required in RAHD to improve long-term survival.

Pharmacotherapy During Saphenous Vein Graft Intervention.

Coronary revascularization using saphenous vein grafts is an important treatment modality for patients with severe coronary artery disease. Percutaneous intervention of these grafts is often the best option for patients who develop severe stenosis of the vein grafts. Use of adjunctive glycoprotein IIb/IIIa inhibitors does not confer added benefit with ischemic endpoints as compared with heparin alone, but it increases the risk of bleeding. Bivalirudin used as the primary anticoagulant lowers the risk of bleeding. No-reflow frequently complicates vein graft interventions but can be treated with vasoactive agents such as calcium channel blockers, adenosine, and nitroprusside.