Physiological Assessment with iFR prior to FFR Measurement in Left Main Disease.

Despite guideline-based recommendation of the interchangeable use of instantaneous wave-free ratio (iFR) and fractional flow reserve (FFR) to guide revascularization decision-making, iFR/FFR could demonstrate different physiological or clinical outcomes in some specific patient or lesion subsets. Therefore, we sought to investigate the impact of difference between iFR and FFR-guided revascularization decision-making on clinical outcomes in patients with left main disease (LMD). In this international multicenter registry of LMD with physiological interrogation, we identified 275 patients in whom physiological assessment was performed with both iFR/FFR. Major adverse cardiovascular event (MACE) was defined as a composite of death, non-fatal myocardial infarction, and ischemia-driven target lesion revascularization. The receiver-operating characteristic analysis was performed for both iFR/FFR to predict MACE in respective patients in whom revascularization was deferred and performed. In 153 patients of revascularization deferral, MACE occurred in 17.0% patients. The optimal cut-off values of iFR and FFR to predict MACE were 0.88 (specificity:0.74; sensitivity:0.65) and 0.76 (specificity:0.81; sensitivity:0.46), respectively. The area under the curve (AUC) was significantly higher for iFR than FFR (0.74; 95%CI 0.62-0.85 vs. 0.62; 95%CI 0.48-0.75; p = 0.012). In 122 patients of coronary revascularization, MACE occurred in 13.1% patients. The optimal cut-off values of iFR and FFR were 0.92 (specificity:0.93; sensitivity:0.25) and 0.81 (specificity:0.047; sensitivity:1.00), respectively. The AUCs were not significantly different between iFR and FFR (0.57; 95%CI 0.40-0.73 vs. 0.46; 95%CI 0.31-0.61; p = 0.43). While neither baseline iFR nor FFR was predictive of MACE in patients in whom revascularization was performed, iFR-guided deferral seemed to be safer than FFR-guided deferral.

Comparison of Paravalvular Leak in SAPIEN 3 and EVOLUT PRO Valves in Transcatheter Aortic Valve Replacement: A Multicenter Registry.

Paravalvular leak (PVL), conduction disturbances, and vascular complications remain the most common complications after TAVR. To address these adverse outcomes, the third generation of transcatheter heart valves has been developed. The last generation prosthesis provides an outer pericardial wrap for enhanced sealing and PVL prevention. This study aimed to compare the incidence and severity of PVL and 1-year survival after TAVR using SAPIEN 3 with those using EVOLUT PRO. An observational retrospective analysis was conducted in 1,481 patients who underwent TAVR for symptomatic severe aortic stenosis in 6 different European centers. The primary end point was to assess the frequency and severity of PVL at 30 days after TAVR. The secondary end point was to compare 1-year survival using EVOLUT PRO with that using SAPIEN 3. SAPIEN 3 transcatheter heart valve was implanted in 78.3% of study participants (n = 1,160) whereas EVOLUT PRO was implanted in 21.7% (n = 321). PVL is more commonly observed in patients treated with EVOLUT PRO at prehospital discharge (55.1% vs 37.3%) and at 1-month (51% vs 41.4%) and 1-year (51.3% vs 39.3%) follow-up. This difference mainly concerns low-grade (mild/trace) PVL. The frequency of high-degree (moderate/severe) PVL was almost similar in both groups throughout the study period (5.3% vs 5.8% before hospital discharge, 4% vs 3.1% at 1 month, and 3.2% vs 4.9% at 1 year). No significant difference in survival over 1 year has been observed (hazard ratio 0.73 [0.33 to 1.63], p = 0.442) (Graphical abstract). In conclusion, the detection rate of PVL after TAVR with third-generation heart valves remains high, and there are no major differences between the devices regarding the frequency of significant (moderate/severe) PVL and survival.

Deferred Versus Performed Revascularization for Left Main Coronary Disease With Hemodynamic Significance.

BACKGROUND: The majority of randomized controlled trials of revascularization decision-making excludes left main coronary artery disease (LMD). Therefore, contemporary clinical outcomes of patients with stable coronary artery disease and LMD with proven ischemia remain poorly understood. The aim of this study was to assess the long-term clinical outcomes of physiologically significant LMD according to the treatment strategies of revascularization versus revascularization deferral. METHODS: In this international multicenter registry of stable LMD interrogated with the instantaneous wave-free ratio, patients with physiologically significant ischemia (instantaneous wave-free ratio ≤0.89) were analyzed according to the coronary revascularization (n=151) versus revascularization deferral (n=74). Propensity score matching was performed to adjust for baseline clinical characteristics. The primary end point was a composite of death, nonfatal myocardial infarction, and ischemia-driven target lesion revascularization of left main stem. The secondary end points were as follows: cardiac death or spontaneous LMD-related myocardial infarction; and ischemia-driven target lesion revascularization of left main stem. RESULTS: At a median follow-up period of 2.8 years, the primary end point occurred in 11 patients (14.9%) in the revascularized group and 21 patients (28.4%) in the deferred group (hazard ratio, 0.42 [95% CI, 0.20-0.89]; P=0.023). For the secondary end points, cardiac death or LMD-related myocardial infarction occurred significantly less frequently in the revascularized group (0.0% versus 8.1%; P=0.004). The rate of ischemia-driven target lesion revascularization of left main stem was also significantly lower in the revascularized group (5.4% versus 17.6%; hazard ratio, 0.20 [95% CI, 0.056-0.70]; P=0.012). CONCLUSIONS: In patients who underwent revascularization for stable coronary artery disease and physiologically significant LMD determined by instantaneous wave-free ratio, the long-term clinical outcomes were significantly improved as compared with those in whom revascularization was deferred.

Physiology-guided PCI versus CABG for left main coronary artery disease: insights from the DEFINE-LM registry.

There have been no studies comparing clinical outcomes of physiology-guided revascularization in patients with unprotected left main coronary disease (ULMD) between percutaneous coronary intervention (PCI) vs. coronary artery bypass grafting (CABG). The aim of this study was to assess the long-term clinical outcomes between PCI and CABG of patients with physiologically significant ULMD. From an international multicenter registry of ULMD patients interrogated with instantaneous wave-free ratio (iFR), we analyzed data from 151 patients (85 PCI vs. 66 CABG) who underwent revascularization according to the cutoff value of iFR ≤ 0.89. Propensity score matching was employed to adjust for baseline clinical characteristics. The primary endpoint was a composite of all-cause death, non-fatal myocardial infarction, and ischemia-driven target lesion revascularization. The secondary endpoints were the individual components of the primary endpoint. Mean age was 66.6 (± 9.2) years, 79.2% male. Mean SYNTAX score was 22.6 (± 8.4) and median iFR was 0.83 (IQR 0.74-0.87). After performing propensity score matching analysis, 48 patients treated with CABG were matched to those who underwent PCI. At a median follow-up period of 2.8 years, the primary endpoint occurred in 8.3% in PCI group and 20.8% in CABG group, respectively (HR 3.80; 95% CI 1.04-13.9; p = 0.043). There was no difference in each component of the primary event (p > 0.05 for all). Within the present study, iFR-guided PCI was associated with lower cardiovascular events rate in patients with ULMD and intermediate SYNTAX score, as compared to CABG. State-of-the-art PCI vs. CABG for ULMD. Study design and primary endpoint in patients with physiologically significant ULMD. MACE was defined as the composite of all-cause death, non-fatal myocardial infarction, and target lesion revascularization. The blue line denotes the PCI arm, and the red line denotes the CABG arm. PCI was associated with significantly lower risk of MACE than CABG. CABG: coronary artery bypass grafting; iFR: instantaneous wave-free ratio; MACE: major adverse cardiovascular events; PCI: percutaneous coronary intervention; ULMD: unprotected left main coronary artery disease.

Pre-dilation and Post-dilation in Transcatheter Aortic Valve Replacement: Indications, Benefits and Risks.

Transcatheter aortic valve replacement (TAVR) is an established treatment for patients with symptomatic severe aortic stenosis. In recent years, an emphasis has been placed on simplification of the procedure. Balloon predilation was initially considered a mandatory step to cross and prepare the stenotic aortic valve, but several studies demonstrated the feasibility of performing TAVR without balloon valvuloplasty. Balloon postdilation of the implanted valve is sometimes required to optimise results, although many patients do not require this step. Contemporary consensus advocates an individualised approach to TAVR procedures and so balloon pre- and post-dilation are performed selectively. This review aims to outline the advantages and disadvantages of balloon pre- and post-dilation and to identify the scenarios in which they are required during TAVR procedures.

Secondary Femoral Access Hemostasis During Transcatheter Aortic Valve Replacement: Impact of Vascular Closure Devices.

BACKGROUND: Vascular and bleeding complications related to secondary femoral access site are frequent in patients undergoing transcatheter aortic valve replacement (TAVR), and their occurrence is associated to poorer outcomes. We aimed to evaluate the clinical impact of vascular closure devices (VCDs) for secondary femoral access hemostasis in TAVR procedures. METHODS: This was a multicenter study including 4031 patients who underwent TAVR (mean age, 81 ± 8 years; mean Society of Thoracic Surgeons [STS] score, 4.9 [interquartile range, 3.3-7.6]), and had a secondary femoral access. The 30-day clinical outcomes were analyzed according to femoral access-site hemostasis (manual compression vs VCD), and according to the type of VCD (Perclose [Abbott Cardiovascular] vs Angio-Seal [Terumo Interventional Systems]) using a propensity-matched, multivariable, logistic regression model. RESULTS: Manual compression was used in 941 patients (23.3%) and VCDs were used in 3090 patients (76.7%; Perclose in 1549 patients [38.4%] and Angio-Seal in 1541 patients [38.2%]) for secondary femoral access hemostasis. Vascular complications related to secondary access site occurred in 162 patients (4%), and were more frequent in patients who underwent manual compression (7.2%) compared with VCD hemostasis (3%; adjusted P<.001). In the VCD group, the use of Angio-Seal (vs Perclose) was associated with a higher rate of vascular complications (3.7% vs 2.4%, respectively; adjusted P=.02), femoral artery pseudoaneurysm (1.3% vs 0.4%, respectively; adjusted P<.01), invasive treatment requirement for treating vascular complications (surgery: 0.8% vs 0.3%, respectively [adjusted P=.03]; and thrombin injection: 0.9% vs 0%, respectively [adjusted P<.001]). CONCLUSION: VCDs represented a safer and more effective alternative compared with manual compression for secondary femoral access-site hemostasis in patients undergoing TAVR procedures, and the Perclose VCD was associated with the lowest risk of vascular complications. Future randomized studies are warranted.

Correlation of Intravascular Ultrasound and Instantaneous Wave-Free Ratio in Patients With Intermediate Left Main Coronary Artery Disease.

BACKGROUND: There is great degree of interobserver variability in the visual angiographic assessment of left main coronary disease (LMCD). Fractional flow reserve and intravascular ultrasound are often used in this setting. The use of instantaneous wave-free ratio (iFR) for evaluation of LMCD has not been well studied. The aim of this study is to evaluate the use of iFR in the assessment of angiographically intermediate LMCD. METHODS: This is an international multicenter retrospective observational study of patients who underwent both iFR and intravascular ultrasound evaluation for angiographically intermediate LMCD. An independent core laboratory performed blinded off-line analysis of all intravascular ultrasound data. A minimum lumen area of 6 mm2 was used as the cutoff for significant disease. RESULTS: One hundred twenty-five patients (mean age, 68.4±9.5 years, 84.8% male) were included in this analysis. Receiver operating curve analysis showed that an iFR of ≤0.89 identified minimum lumen area <6 mm2 with an area under the curve of 0.77 (77% sensitivity, 66% specificity; P<0.0001). Among the 69 patients without ostial left anterior descending artery or left circumflex artery disease, receiver operating curve analysis showed that an iFR of ≤0.89 identified minimum lumen area <6 mm2 with an area under the curve of 0.84 (70% sensitivity, 84% specificity; P<0.0001). The correlation was not significantly different when the body surface area was considered. CONCLUSIONS: In this study, in patients with intermediate LMCD, iFR of ≤0.89 correlates with intravascular ultrasound minimum lumen area <6 mm2 regardless of body surface area. The current study supports the use of iFR for the evaluation of intermediate LMCD.

Clinical Impact of Crossover Techniques for Primary Access Hemostasis in Transfemoral Transcatheter Aortic Valve Replacement Procedures.

OBJECTIVES: To determine the occurrence of vascular complications (VCs) following transfemoral transcatheter aortic valve replacement (TAVR) with new-generation devices according to the use of a crossover technique (COT). BACKGROUND: The use of a COT (with/without balloon) has been associated with a reduction of VCs in TAVR patients. However, scarce data support its use with second-generation devices. Also, its potential benefit in obese patients (at high-risk of VCs) has not been elucidated. METHODS: A multicenter study including 2214 patients who underwent full percutaneous transfemoral TAVR (COT, 1522 patients; no COT, 692 patients). Thirty-day events were evaluated according to the use of a COT using a multivariate logistic regression model. A subanalysis was performed in obese patients. RESULTS: Primary access major VCs (3.5% COT vs 3.9% no COT; P=.19), major/life-threatening bleeding (3.4% COT vs 2.0% no COT; P=.33), and mortality rates (2.4% COT vs 2.6% no COT; P=.23) were similar between groups. However, minor VCs (11.7% COT vs 5.9% no COT; P<.001) and postprocedural acute renal failure (8.9% COT vs 3.9% no COT; P<.001) were higher in patients undergoing the COT. In the overall cohort, percutaneous closure device failure was more frequent in obese patients (4.0% in the obese group vs 1.9% in the non-obese group; P<.01), but these differences were no longer significant in those undergoing a COT (3.4% in the obese group vs 2.0% in the non-obese group; P=.12). Indeed, in the subset of obese patients, the COT tended to be associated with fewer VCs (3.4% COT vs 5.9% no COT; P=.09). CONCLUSIONS: The use of a COT was not associated with a reduction of major VCs or improved outcomes. However, some patient subsets, such as those with higher body mass index, may benefit from the use of a COT. These findings would suggest the application of a tailored strategy, following a risk-benefit assessment in each TAVR candidate.

Contemporary use of coronary computed tomography angiography in the planning of percutaneous coronary intervention.

Planning of percutaneous coronary interventions (PCI) is largely based on anatomical information obtained with invasive coronary angiography. Over the last decade, intracoronary information obtained from both imaging and physiological techniques has gradually gained recognition for this purpose. Yet, coronary computed tomography angiography (CCTA) is still ignored by most interventionalists as a tool in the planning of PCI strategies. This has occurred despite major developments in CCTA, including physiological assessment, plaque characterisation, etc. Furthermore, it is foreseeable that many more patients referred to the catheterisation laboratory will have had a prior CCTA study. In this review we discuss the distinct advantages provided by CCTA in studying coronary artery structure and function. We revisit the most frequent scenarios of complex PCI and establish analogies between the use of intracoronary diagnostics and CCTA in setting procedural strategy, and in anticipating specific challenges.

Safety of Revascularization Deferral of Left Main Stenosis Based on Instantaneous Wave-Free Ratio Evaluation.

OBJECTIVES: The aim of this study was to assess the long-term clinical outcomes of patients with left main coronary artery (LM) stenosis in whom treatment strategy was based on the instantaneous wave-free ratio (iFR). BACKGROUND: The overall safety of iFR to guide revascularization decision making in patients with stable coronary artery disease has been established. However, no study has examined the safety of deferral of revascularization of LM disease on the basis of iFR. METHODS: This multicenter observational study included 314 patients in whom LM stenosis was deferred (n = 163 [51.9%]) or revascularized (n = 151 [48.1%]) according to the iFR cutoff ≤0.89. The primary endpoint was a composite of all-cause death, nonfatal myocardial infarction, and ischemia-driven target lesion revascularization. The secondary endpoints were each individual component of the primary endpoint and also cardiac death. RESULTS: At a median follow-up period of 30 months, the primary endpoint occurred in 15 patients (9.2%) in the deferred group and 22 patients (14.6%) in the revascularized group (hazard ratio: 1.45; 95% confidence interval: 0.75 to 2.81; p = 0.26), indicating no evidence of a significant difference between the 2 groups. For the secondary endpoints, findings in the iFR-based deferral and revascularization groups were as follows: all-cause death, 3.7% versus 4.6%; cardiac death, 1.2% versus 2.0%; nonfatal myocardial infarction, 2.5% versus 5.3%; and target lesion revascularization, 4.3% versus 5.3% (p > 0.05 for all). CONCLUSIONS: Deferral of revascularization of LM stenosis on the basis of iFR appears to be safe, with similar long-term outcomes to those in patients in whom LM revascularization was performed according to iFR values.

Comparison of Transfemoral Versus Transradial Secondary Access in Transcatheter Aortic Valve Replacement.

BACKGROUND: Transfemoral approach has been commonly used as secondary access in transcatheter aortic valve replacement (TAVR). Scarce data exist on the use and potential clinical benefits of the transradial approach as secondary access during TAVR procedures. The objective of the study is to determine the occurrence of vascular complications (VC) and clinical outcomes according to secondary access (transfemoral versus transradial) in patients undergoing TAVR. METHODS: This was a multicenter study including 4949 patients who underwent TAVR (mean age, 81±8 years, mean Society of Thoracic Surgeons score, 4.9 [3.3-7.5]). Transfemoral and transradial approaches were used as secondary access in 4016 (81.1%) and 933 (18.9%) patients, respectively. The 30-day clinical events (vascular and bleeding complications, stroke, acute kidney injury, and mortality) were evaluated and defined according to Valve Academic Research Consortium-2 criteria. Clinical outcomes were analyzed according to the secondary access (transfemoral versus transradial) in the overall population and in a propensity score-matched population involving 2978 transfemoral and 928 transradial patients. RESULTS: Related-access VC occurred in 834 (16.9%) patients (major VC, 5.7%) and were related to the secondary access in 172 (3.5%) patients (major VC, 1.3%). The rate of VC related to the secondary access was higher in the transfemoral group (VC, 4.1% versus 0.9%, P<0.001; major VC, 1.6% versus 0%, P<0.001). In the propensity score-matched population, VC related to the secondary access remained higher in the transfemoral group (4.7% versus 0.9%, P<0.001; major VC, 1.8% versus 0%, P<0.001), which also exhibited a higher rate of major/life-threatening bleeding events (1.0% versus 0%, P<0.001). Significant differences between secondary access groups were observed regarding the rates of 30-day stroke (transfemoral: 3.1%, transradial: 1.6%; P=0.043), acute kidney injury (transfemoral: 9.9%, transradial: 5.7%; P<0.001), and mortality (transfemoral: 4.0%, transradial: 2.4%, P=0.047). CONCLUSIONS: The use of transradial approach as secondary access in TAVR procedures was associated with a significant reduction in vascular and bleeding complications and improved 30-day outcomes. Future randomized studies are warranted.

Disminución de la fracción de expulsión del ventrículo izquierdo por estrés con adenosina como predictor de isquemia.

INTRODUCCIÓN: En estudios de medicina nuclear se ha observado que la disminución de la fracción de expulsión del ventrículo izquierdo (FEVI) se asocia con enfermedad coronaria trivascular; en resonancia magnética cardiaca (RMC) no se ha estudiado el papel que desempeña la disminución de la FEVI. OBJETIVO: Evaluar la asociación entre la disminución de la FEVI y la isquemia cardiaca en pacientes con estudios de RMC con adenosina. MÉTODO: Estudio transversal comparativo. Los criterios de inclusión fueron pacientes evaluados con RMC con adenosina entre enero de 2009 y junio de 2015. Se comparó el cambio en la FEVI en pacientes con estudio positivo versus pacientes con estudio negativo para isquemia por este método. RESULTADOS: Se incluyeron 59 pacientes: 41 del sexo masculino (70 %), edad de 59.7 ± 10.9 años; 38 % de los estudios fueron positivos para isquemia. La delta de la FEVI (FEVI postestrés - FEVI reposo) fue de -0.16 ± 5.9 versus 5.3 ± 4.7 (p<0.001) en pacientes con y sin isquemia, respectivamente. CONCLUSIÓN: Los pacientes con estudios positivos para isquemia tuvieron menor delta FEVI que los que tuvieron estudios negativos para isquemia. BACKGROUND: The decrease in left ventricular ejection fraction (LVEF) has been observed to be associated with three-vessel coronary disease in nuclear medicine studies; however, the role played by LVEF decrease has not been studied with cardiovascular magnetic resonance (CMR). OBJECTIVE: To assess the association between LVEF decrease and cardiac ischemia in patients with CMR studies with adenosine. METHOD: Cross-sectional, comparative study. Inclusion criteria were: patients assessed with CMR with adenosine between January 2009 and June 2015. LVEF change was compared between patients testing positive for ischemia versus those who tested negative. RESULTS: Fifty nine patients were included: 41 were males (70%), mean age was 59.7 ± 10.9 years; 38% of the studies tested positive for ischemia. Delta LVEF (post-stress LVEF ­ resting LVEF) was ­0.16 ± 5.9 versus 5.3 ± 4.7 (p < 0.001) in patients with and without ischemia, respectively. CONCLUSION: Patients who tested positive for ischemia had lower delta LVEF than those with negative studies for ischemia.

Risk factors for the development of postoperative pneumonia after cardiac surgery / Factores de riesgo para desarrollar neumonía postquirúrgica en pacientes operados de cirugía cardiaca

Abstract Objective Identify risk factors that determine pneumonia development in patients who have undergone cardiac surgery. Methods Prospective study of a single cohort in a postoperative intensive care unit at a tertiary care center, encompassing all patients undergoing cardiac surgery from January to July 2014. Results 31 postoperative pneumonia cases were enrolled out of 211 patients (14.6%). The following independent risk factors were identified: hypertension (OR: 3.94, p = 0.01), chronic renal failure (OR: 13.67, p = 0.02), reintubation (OR: 22.29, p = 0.001) and extubation after 6 h (OR: 15.81, p = 0.005). Conclusions Main determinants for pneumonia after surgery were hypertension, chronic renal failure, extubation after 6 h and reintubation.

Resumen Objetivo Identificar los factores de riesgo para desarrollar neumonía en el periodo postquirúrgico de pacientes sometidos a cirugía cardiaca. Método Estudio de cohorte prospectiva que incluye pacientes > 18 años sometidos a cirugía cardiaca de enero a julio de 2014, en el Instituto Nacional de Cardiología Ignacio Chávez, México D.F. Se considera un valor de p < 0.05 como significativo. Resultados De un total de 211 pacientes operados, se diagnosticaron 31 casos de neumonía postquirúrgica (14.6%). Se identificaron los siguientes factores de riesgo independientes para desarrollar neumonía: la hipertensión arterial sistémica (OR: 3.94, p = 0.01), el antecedente de insuficiencia renal crónica (OR: 13.67, p = 0.02). La reintubación (OR: 22.29, p = 0.001) y permanecer intubado por más de 6 horas (OR: 15.81, p = 0.005). Conclusiones Los principales factores de riesgo independientes para desarrollar neumonía en el periodo postquirúrgico son la preexistencia de hipertensión arterial sistémica o insuficiencia renal crónica, la reintubación y permanecer intubado durante más de 6 h.

Risk factors for the development of postoperative pneumonia after cardiac surgery.

OBJECTIVE: Identify risk factors that determine pneumonia development in patients who have undergone cardiac surgery. METHODS: Prospective study of a single cohort in a postoperative intensive care unit at a tertiary care center, encompassing all patients undergoing cardiac surgery from January to July 2014. RESULTS: 31 postoperative pneumonia cases were enrolled out of 211 patients (14.6%). The following independent risk factors were identified: hypertension (OR: 3.94, p=0.01), chronic renal failure (OR: 13.67, p=0.02), reintubation (OR: 22.29, p=0.001) and extubation after 6h (OR: 15.81, p=0.005). CONCLUSIONS: Main determinants for pneumonia after surgery were hypertension, chronic renal failure, extubation after 6h and reintubation.