Clinical impact of the heart team on the outcomes of surgical aortic valve replacement among octogenarians.

OBJECTIVES: The effectiveness of a multidisciplinary heart team in the management of patients with severe symptomatic aortic stenosis is unknown. This study evaluated the impact of a heart team on the outcomes of surgical aortic valve replacement in octogenarians. METHODS: Between May 2007 and January 2016, 528 patients aged 80 years or more were referred to our institutional heart team for a transcatheter aortic valve replacement. Among these, 101 were redirected to surgical aortic valve replacement (heart team group). These patients were compared with a surgical aortic valve replacement cohort (n = 506) without prior heart team screening (non-heart team group), taken from the same time period. Propensity score matching with bootstrap analysis was performed; 76 heart team patients were matched to 76 non-heart team patients. Early and late outcomes including survival and readmission for cardiovascular causes were compared. RESULTS: Matched subgroups were largely comparable; congestive heart failure and echocardiographic pulmonary hypertension were more prevalent in the heart team group. In-hospital mortality was significantly lower in the matched heart team group (0% vs 6.0%, bootstrap mean difference 6.0%, 95% confidence interval, 2.2-9.8). The risk of stroke, low cardiac output state, reexploration for bleeding, pneumonia, and prolonged ventilation was also significantly lower in the heart team group. There was no significant between-group difference regarding late survival (hazard ratio, 0.86, 95% confidence interval, 0.55-1.33, P = .49) or readmission for cardiovascular reasons (hazard ratio, 0.70, 95% confidence interval, 0.41-1.20, P = .19). CONCLUSIONS: Preoperative multidisciplinary assessment of octogenarians by a heart team was associated with lower in-hospital mortality and adverse events after surgical aortic valve replacement.

Effectiveness of low rate fluoroscopy at reducing operator and patient radiation dose during transradial coronary angiography and interventions.

OBJECTIVES: This study sought to determine the efficacy of low rate fluoroscopy at 7.5 frames/s (FPS) versus conventional 15 FPS for reduction of operator and patient radiation dose during diagnostic coronary angiography (DCA) and percutaneous coronary intervention (PCI) via the transradial approach (TRA). BACKGROUND: TRA for cardiac catheterization is potentially associated with increased radiation exposure. Low rate fluoroscopy has the potential to reduce radiation exposure. METHODS: Patients undergoing TRA diagnostic angiography ± ad-hoc PCI were randomized to fluoroscopy at 7.5 FPS versus 15 FPS prior to the procedure. Both 7.5 and 15 FPS fluoroscopy protocols were configured with a fixed dose per pulse of 40 nGy. Primary endpoints were operator radiation dose (measured with dosimeter attached to the left side of the thyroid shield in µSievert [µSv]), patient radiation dose (expressed as dose-area product in Gy·cm(2)), and fluoroscopy time. RESULTS: From October 1, 2012 to August 30, 2013, from a total of 363 patients, 184 underwent DCA and 179 underwent PCI. Overall, fluoroscopy at 7.5 FPS compared with 15 FPS was associated with a significant reduction in operator dose (30% relative reduction [RR], p < 0.0001); and in patient's dose-area product (19% RR; p = 0.022). When stratified by procedure type, 7.5 FPS compared with 15 FPS was associated with significant reduction in operator dose during both DCA (40% RR; p < 0.0001) and PCI (28% RR; p = 0.0011). Fluoroscopy at 7.5 FPS, compared with 15 FPS, was also associated with substantial reduction in patients' dose-area product during DCA (26% RR; p = 0.0018) and during PCI (19% RR; p = 0.13). Fluoroscopy time was similar in 7.5 FPS and 15 FPS groups for DCA (3.4 ± 2.0 min vs. 4.0 ± 4.7 min; p = 0.42) and PCI (11.9 ± 8.4 min vs. 13.3 ± 9.7 min; p = 0.57), respectively. CONCLUSIONS: Fluoroscopy at 7.5 FPS, compared with 15 FPS, is a simple and effective method in reducing operator and patient radiation dose during TRA DCA and PCI.

Risk score, causes, and clinical impact of failure of transradial approach for percutaneous coronary interventions.

OBJECTIVES: To study the causes of and to develop a risk score for failure of transradial approach (TRA) for percutaneous coronary intervention (PCI). BACKGROUND: TRA-PCI failure has been reported in 5% to 10% of cases. METHODS: TRA-PCI failure was categorized as primary (clinical reasons) or crossover failure. Multivariate analysis was performed to determine independent predictors of TRA-PCI failure, and an integer risk score was developed. RESULTS: From January to June 2010, TRA-PCI was attempted in 1,609 (97.3%) consecutive patients, whereas 45 (2.7%) had primary TRA-PCI failure. Crossover TRA-PCI failure occurred in 30 (1.8%) patients. Causes of primary TRA-PCI failure included chronic radial artery occlusion (11%), previous coronary artery bypass graft (27%), and cardiogenic shock (20%). Causes for crossover TRA-PCI failure included: inadequate puncture in 17 patients (57%); radial artery spasm in 5 (17%); radial loop in 4 (13%); subclavian tortuosity in 2 (7%); and inadequate guide catheter support in 2 (7%) patients. Female sex (odds ratio [OR]: 3.2; 95% confidence interval [CI]: 1.95 to 5.26, p < 0.0001), previous coronary artery bypass graft (OR: 6.1; 95% CI: 3.63 to 10.05, p < 0.0001), and cardiogenic shock (OR: 11.2; 95% CI: 2.78 to 41.2, p = 0.0011) were independent predictors of TRA-PCI failure. Risk score values from 0 to 7 predicted a TRA-PCI failure rate from 2% to 80%. CONCLUSIONS: In a high-volume radial center, 2.7% of patients undergoing PCI are excluded from initial TRA on clinical grounds, whereas crossover to femoral approach is required in only 1.8% of the cases. A new simple clinical risk score is developed to predict TRA-PCI failure.

Transapical implantation of the SAPIEN 3 valve.

We report two cases of high-risk aortic stenosis treated with the SAPIEN 3 valve. This is the first procedure performed with this type of valve through the transapical approach. This new balloon-expandable valve incorporates a lower profile cobalt-chromium stent and an additional outer skirt to enhance paravalvular sealing. The procedure was performed without complications and no paravalvular leak was detected in control echocardiogram at follow-up.

Transcatheter aortic valve implantation for the treatment of surgical valve dysfunction ("valve-in-valve"): assessing the risk of coronary obstruction.

Acute coronary obstruction is one of the most feared complications associated with transcatheter aortic valve-in-valve implantation. Strategies for assessing the risk of coronary occlusion during these procedures as well as preventive measures are discussed.

Prominent septal hypertrophy: a contra-indication for transapical aortic valve implantation?

We report a case of transapical aortic valve implantation in a patient with severe left ventricular hypertrophy. The valve was deployed but failed to attain stable seating because of a hypertrophied septal ridge encroaching on the landing zone. Moderate perivalvar insufficiency was also noted. A second valve was deployed in an attempt to achieve stable seating and correct the perivalvar leak. This was unsuccessful and the two-valve complex embolized into the ascending aorta. The valves were moved and seated in the proximal descending thoracic aorta. The technical issues of transapical aortic valve implantation in patients with severe left ventricular hypertrophy are reviewed.

Transcatheter aortic valve-in-valve-in-valve implantation for a failed xenograft.

A 78-year-old gentleman with a diagnosis of symptomatic severe xenograft aortic stenosis with multiple comorbidities was referred for transcatheter aortic valve implantation, that is, a "valve-in-valve" procedure. Transcatheter aortic valve implantation was performed by transapical approach using a balloon-expandable bioprosthesis. During valve deployment, the prosthesis moved toward the left ventricle and a second balloon-expandable valve was implanted within the first one-a "valve-in-valve-in-valve" to avoid further ventricular embolization of the first bioprosthesis. Echocardiography at hospital discharge showed a residual mean transvalvular gradient of 17 mm Hg and trivial paravalvular aortic regurgitation. At 1 year follow-up, the patient was in New York Heart Association functional class II.

Importance of diffuse atherosclerosis in the functional evaluation of coronary stenosis in the proximal-mid segment of a coronary artery by myocardial fractional flow reserve measurements.

The objective of this study was to evaluate the impact of diffuse coronary atherosclerosis on the functional evaluation of moderate coronary lesions in the proximal-mid segment of a coronary artery and its clinical implications. This was a prospective study including 100 consecutive patients with a moderate lesion (45 ± 9% diameter stenosis) in the proximal-mid coronary segment who were evaluated with fractional flow reserve (FFR) measurement. No patient had any other angiographic stenosis distal to the evaluated coronary stenosis. FFR measurements were obtained just distal (~2 to 3 cm) to the lesion (FFR proximal measurement [FFR-PM]) and as distally as possible in the artery (FFR distal measurement [FFR-DM]) after administration of the same dose of intracoronary adenosine. Thirty-nine patients underwent dipyridamole or exercise myocardial single-photon emission computed tomography within 3 months of the FFR study. Mean FFR-PM was significantly higher compared to FFR-DM (0.84 ± 0.08 vs 0.78 ± 0.09, median gradient 0.06, 25th to 75th interquartile range 0.02 to 0.10, p <0.0001). FFR-DM was <0.75 in 33% of patients with FFR-PM ≥0.75, leading to the decision of revascularization in these patients. Performing FFR measurement in the left main/left anterior descending artery predicted a higher gradient between FFR-DM and FFR-PM (odds ratio 4.58, 95% confidence interval 1.4 to 15.03, p = 0.007). FFR-DM exhibited a better correlation with results of myocardial single-photon emission computed tomography compared to FFR-PM (kappa 0.33 vs 0.22, p <0.0001). In conclusion, significant differences between FFR-DM and FFR-PM were observed in patients with moderate coronary stenosis in the proximal-mid segment of a coronary artery, with FFR-DM exhibiting a better correlation with results of noninvasive functional tests. These differences influenced the treatment decision in about 1/3 of patients and highlight the potential clinical relevance of coronary pressure wire positioning for functional evaluation of lesions in the proximal-mid segment of the coronary arteries.

Cardiometabolic effects of rosiglitazone in patients with type 2 diabetes and coronary artery bypass grafts: A randomized placebo-controlled clinical trial.

OBJECTIVES: To assess the efficacy and safety of rosiglitazone on saphenous vein graft (SVG) atherosclerosis prevention and on modification of the global cardiometabolic risk profile. METHODS AND RESULTS: This was a double-blind, randomized, placebo-controlled, multicenter trial which enrolled 193 post-CABG patients with type 2 diabetes. Atherosclerosis changes in one SVG were assessed with intravascular ultrasound at baseline and at 12 months. Serial cardiometabolic assessments were performed. At baseline, both groups had mean HbA(1C)<7%, LDL-cholesterol (LDL-C)<2.3 mmol/l, HDL-cholesterol (HDL-C)>1.0 mmol/l and blood pressure<130/75 mmHg. After 12 months, plaque volume in SVG had increased (median [interquartile range]) by 7.7 mm(3) (-17.2 to 37.9) in the placebo group and decreased by 0.3mm(3) (-19.1 to 22.3) in the rosiglitazone group (P=0.22). Compared to placebo, rosiglitazone treated patients had a higher (mean + or - SD) body weight (89 + or - 15 kg vs. 84 + or - 15 kg, P=0.02) at the end of the study, mostly related to an increment in subcutaneous adipose tissue. Rosiglitazone treated patients also displayed further improvements in glycemic control compared to placebo (HbA(1C): 6.4 + or - 0.7% vs. 7.0 + or - 0.9%, P<0.001) as well as in several cardiometabolic parameters such as lipids (HDL-C: 1.16 + or - 0.28 mmol/l vs. 1.06 + or - 0.23 mmol/l, P=0.003), inflammatory profile (C-reactive protein: 0.92 mg/l [0.51-1.56] vs. 1.37 mg/l [0.79-3.08], P=0.02), and adiponectin levels (11.1 microg/ml [8.19-17.9] vs. 4.65 microg/ml [3.27-7.15], P<0.001). There was no significant difference in the incidence of serious adverse cardiovascular events. However, more patients in the rosiglitazone group had peripheral oedema (33% vs. 18%, P=0.0019). CONCLUSION: After a 12-month follow-up, we found no evidence for a statistically significant effect of rosiglitazone on SVG atherosclerosis whereas significant effects on glycemic control and on the cardiometabolic risk profile appeared to be modulated in part by changes in subcutaneous adiposity.

Transcatheter aortic valve implantation with "no touch" of the aortic arch for the treatment of severe aortic stenosis associated with complex aortic atherosclerosis.

We present the case of an 80-year-old woman diagnosed with severe aortic stenosis and complex aortic atherosclerotic plaques who underwent transapical TAVI guided by transesophageal echocardiography and fluoroscopy with no catheter/wire manipulation across the aortic arch to avoid any systemic embolism.

Predicting late myocardial recovery and outcomes in the early hours of ST-segment elevation myocardial infarction traditional measures compared with microvascular obstruction, salvaged myocardium, and necrosis characteristics by cardiovascular magnetic resonance.

OBJECTIVES: The aim of this study was to determine whether a very early imaging strategy improves the prediction of late systolic dysfunction and poor outcomes in ST-segment elevation myocardial infarction (STEMI) compared with traditional predictors. BACKGROUND: Earlier prediction of poor outcomes after STEMI is desirable, because it will allow tailored therapy at the earliest possible time, when benefits might be greatest. METHODS: One hundred and three patients with acute STEMI were studied by contrast-enhanced cardiovascular magnetic resonance within 12 h of primary angioplasty and at 6 months and followed >2 years. The primary end point was left ventricular (LV) dysfunction, whereas poor outcomes were a key secondary end point. RESULTS: Traditional risk factors were only modest predictors of late LV dysfunction. Late gadolinium enhancement (LGE) volume maintained a stronger association to LV ejection fraction change than infarct transmurality, microvascular obstruction, or myocardial salvage during STEMI (p = 0.02). Multivariable logistic regression identified LGE volume during STEMI as the best predictor of late LV dysfunction (odds ratio: 1.36, p = 0.03). An LGE >or=23% of LV during STEMI accurately predicted late LV dysfunction (sensitivity 89%, specificity 74%). The LGE volume provided important incremental benefit for predicting late dysfunction (area under the curve = 0.92, p or=23% carried a hazard ratio of 6.1 for adverse events (p < 0.0001). CONCLUSIONS: During the hyperacute phase of STEMI, LGE volume provides the strongest association and incremental predictive value for late systolic dysfunction and discerns poor late outcomes.

Percutaneous versus surgical delivery of autologous myoblasts after chronic myocardial infarction: an in vivo cardiovascular magnetic resonance study.

BACKGROUND: Stem cell transplantation for chronic myocardial infarction (MI) provides variable benefits. Most clinical trials have relied on surgical delivery, where results are biased by simultaneous coronary bypass. When bypass is not indicated, percutaneous delivery may provide comparable efficacy with reduced risk. We evaluated in vivo by cardiovascular magnetic resonance (CMR) the effects of autologous myoblast (AM) transplantation on myocardial morphology, function, perfusion and scar, and compared percutaneous versus surgical delivery. METHODS: Chronic MI was completed in 10 Yucatan mini-pigs. Three months later, AM were injected in half by percutaneous NOGA(R) system and in the other half by surgical mini-thoracotomy. CMR was performed at baseline and 6 months after transplantation. RESULTS: Six months after injection, AM transplantation led to a 26.3% decrease in indexed left ventricular end-diastolic volume (95% CI: 20.1-29.7%; P = 0.02), 25.5% thickening of the infarct-related segment (IRS) wall (95% CI: 19.6-33.2%; P = 0.03), and 20.9% increase in left ventricle (LV) ejection fraction (95% CI: 15.8-28.4%; P = 0.03). Scar tissue within IRS decreased by 29.4% (95% CI: 19.2-37.0%; P = 0.03), whereas the number of nonviable segments decreased by 25.0% (95% CI: 16.4-32.6%; P = 0.04). Myocardial perfusion of IRS improved by 29.1% (95% CI: 19.7-36.1%; P = 0.04). The arrhythmogenic peri-infarct zone increased by 33.2% (95% CI: 21.4-44.1%; P = 0.01) after AM transplantation. Benefits were similar by percutaneous or by surgical delivery. CONCLUSIONS: Comprehensive in vivo CMR reveals reversed remodeling and improved systolic function, perfusion, and scar characteristics after AM transplantation. A relative increase in the arrhythmogenic peri-infarct border zone may explain previously reported arrhythmia. Percutaneous and surgical transplantation of AM both lead to comparable improvements in chronic MI.

A multicentre, randomized, double-blind placebo-controlled trial evaluating rosiglitazone for the prevention of atherosclerosis progression after coronary artery bypass graft surgery in patients with type 2 diabetes. Design and rationale of the VeIn-Coronary aTherOsclerosis and Rosiglitazone after bypass surgerY (VICTORY) trial.

BACKGROUND: The number of patients with coronary artery disease and type 2 diabetes will increase dramatically over the next decade. Diabetes has been related to accelerated atherosclerosis and many patients with diabetes will require coronary artery bypass graft (CABG) surgery utilizing saphenous vein grafts. After CABG, accelerated atherosclerosis in saphenous vein grafts leads to graft failure in approximately 50% of cases over a 10-year period. Rosiglitazone, a peroxisome proliferator-activated receptor-gamma agonist, has been shown to improve multiple metabolic parameters in patients with type 2 diabetes. However, its role in the prevention of atherosclerosis progression is uncertain. STUDY DESIGN: VeIn-Coronary aTherOsclerosis and Rosiglitazone after bypass surgerY (VICTORY) is a cardiometabolic trial in which patients with type 2 diabetes, one to 10 years after CABG, will be randomly assigned to receive rosiglitazone (up to 8 mg/day) or a placebo after qualifying angiography and intravascular ultrasound of a segment of one vein graft with or without a native anastomosed coronary artery. A comprehensive set of athero-thrombo-inflammatory markers will be serially assessed during the 12-month follow-up period. Body fat distribution and body composition will be assessed by computed tomography and dual energy x-ray absorptiometry, respectively, at baseline, six months and 12 months follow-up. For atherosclerosis progression evaluation, repeat angiography and intravascular ultrasound will be performed after 12 months follow-up. The primary end point of the study will be the change in atherosclerotic plaque volume in a 40 mm or longer segment of one vein graft. CONCLUSIONS: The VICTORY trial is the first cardiometabolic study to evaluate the antiatherosclerotic and metabolic effects of rosiglitazone in post-CABG patients with type 2 diabetes.

Rapid pacing technique for preventing ventricular tears during transapical aortic valve replacement.

BACKGROUND: Transapical aortic valve replacement (TAVR) is emerging as an alternative to surgical aortic valve replacement in high-risk or non-operable patients with aortic stenosis. However, this approach might be associated with major bleeding complications during the removal of the introducer sheath from the left ventricular apex. We describe a simple technique to minimize this complication. METHODS: The technique consists of installing a temporary pacing Swan-Ganz catheter, using large-needle Ethibond 2-0 sutures with large pledgets for apical pursestrings, and removing the 26F sheath from the ventricular apex tension-free by rapid ventricular pacing (>150 bpm). RESULTS: We have completed 21 TAVR using rapid ventricular pacing. This technique considerably decreased the amount of apical tearing and sutures to be added at the apex. Six of 21 patients had partial ventricular tearing that was amenable to repair using rapid pacing, thereby avoiding urgent cardiopulmonary bypass. CONCLUSION: The present report describes a technique to reduce the occurrence of ventricular tears and major bleeding during TAVR.

Severe valvular regurgitation and late prosthesis embolization after percutaneous aortic valve implantation.

We report the case of a 79-year-old man with low-flow, low-gradient aortic stenosis who underwent transapical aortic valve implantation. The deployment of a 26-mm Edwards SAPIEN valve (Edwards Lifesciences Inc, Irvine, CA) was complicated with the occurrence of severe central aortic regurgitation that was successfully treated with the implantation of a second valve ("valve-in-valve"). Postoperative progress was satisfactory but 2 days after the procedure he suddenly developed cardiogenic shock secondary to the migration of the aortic bioprothesis into the left ventricular outflow tract. Open-heart surgery was undertaken to remove the valves and perform standard aortic valve replacement, but the patient died perioperatively.

Nonrandomized comparison of coronary artery bypass surgery and percutaneous coronary intervention for the treatment of unprotected left main coronary artery disease in octogenarians.

BACKGROUND: The objective of the present study was to compare the midterm follow-up results of percutaneous coronary intervention (PCI) and coronary bypass graft surgery (CABG) for the treatment of unprotected left main coronary artery disease in octogenarians. METHODS AND RESULTS: A total of 249 consecutive patients > or =80 years of age diagnosed with left main coronary artery disease underwent coronary revascularization in our center between January 2002 and January 2008; 145 patients underwent CABG, and 104 patients had PCI. Major adverse cardiac and cerebrovascular events (MACCE [cardiac death, myocardial infarction, cerebrovascular event, revascularization]) were evaluated at a mean follow-up of 23 +/- 16 months. Patients who underwent PCI were older; had higher creatinine levels, lower ejection fraction, and higher EuroSCORE; and presented more frequently with an acute coronary syndrome. Drug-eluting stents were used in 48% of PCI patients. A propensity score analysis was performed to adjust for baseline differences between the 2 groups. Survival free of cardiac death or myocardial infarction (PCI, 65.4%; CABG, 69.7%) and MACCE-free survival (PCI, 56.7%; CABG, 64.8%) at follow-up were similar between the groups (adjusted hazard ratio for survival free of cardiac death or myocardial infarction, 1.28; 95% CI, 0.64 to 2.56; P=0.47; adjusted hazard ratio for MACCE-free survival, 1.11; 95% CI, 0.59 to 2.0; P=0.73). The EuroSCORE value was an independent predictor of MACCE regardless of the type of revascularization (hazard ratio, 1.17 for each EuroSCORE increase of 1 point; 95% CI, 1.09 to 1.25; P<0.0001). CONCLUSIONS: In this single-center, nonrandomized study, there were no significant differences in cardiac death or myocardial infarction and MACCE between CABG and PCI for the treatment of left main coronary artery disease in octogenarians after a mean follow-up of 2 years. Baseline EuroSCORE was the most important predictor of MACCE regardless of the type of revascularization. Randomized studies comparing both revascularization strategies in this high-risk coronary population are warranted.

A randomized study comparing same-day home discharge and abciximab bolus only to overnight hospitalization and abciximab bolus and infusion after transradial coronary stent implantation.

BACKGROUND: Systematic use of coronary stents and optimized platelet aggregation inhibition has greatly improved the short-term results of percutaneous coronary interventions. Transradial percutaneous coronary interventions have been associated with a low risk of bleeding complications. It is unknown whether moderate- and high-risk patients can be discharged safely the same day after uncomplicated transradial percutaneous coronary interventions. METHODS AND RESULTS: We randomized 1005 patients after a bolus of abciximab and uncomplicated transradial percutaneous coronary stent implantation either to same-day home discharge and no infusion of abciximab (group 1, n=504) or to overnight hospitalization and a standard 12-hour infusion of abciximab (group 2, n=501). The primary composite end point of the study was the 30-day incidence of any of the following events: death, myocardial infarction, urgent revascularization, major bleeding, repeat hospitalization, access site complications, and severe thrombocytopenia. The noninferiority of same-day home discharge and bolus of abciximab only compared with overnight hospitalization and abciximab bolus and infusion was evaluated. Two thirds of patients presented with unstable angina and approximately 20% presented with high-risk acute coronary syndrome prior to the procedure. The incidence of the primary end point was 20.4% in group 1 and 18.2% in group 2 (P=0.017 for noninferiority) with a troponin T-based definition of myocardial infarction; the incidence of the primary end point was 11.1% in group 1 and 9.6% in group 2 (P=0.0004 for noninferiority) with a creatinine kinase myocardial band-based definition of myocardial infarction. No death occurred. Rate of major bleeding in both groups was extremely low at 0.8% and 0.2%, respectively. From 504 patients randomized in group 1, 88% were discharged home the same day. CONCLUSIONS: Our data suggest that same-day home discharge after uncomplicated transradial coronary stenting and bolus only of abciximab is not clinically inferior, in a wide spectrum of patients, to the standard overnight hospitalization and a bolus followed by a 12-hour infusion. This novel approach offers a safe strategy for same-day home discharge after uncomplicated coronary intervention.