Percutaneous access of the pericardial space is increasingly sought. This is not only due to grow... more Percutaneous access of the pericardial space is increasingly sought. This is not only due to growing prevalence of pericardial effusions and cardiac tamponade, but also the emerging diagnostic and therapeutic potential of the pericardial space for mapping and ablation of arrhythmogenic circuits, biopsy, and drug delivery. Although increasingly performed, percutaneous pericardiocentesis remains a technically challenging procedure with potentially life-threatening complications. Consequently, management of patients with pericardial disease is highly complex. In this chapter we outline a step-by-step approach to percutaneous pericardiocentesis and the required specialised management of pericardial disease patients. Procedural complications are discussed along with their alleviating therapeutic strategies. Furthermore, we describe approaches to the prevention and management of recurrent pericardial effusion including diagnostic and therapeutic procedures such as percutaneous balloon pericardiotomy and intra-pericardial delivery of chemotherapeutics and sclerosing agents.
OBJECTIVES This study evaluates outcomes of pre-emptive alcohol septal ablation (ASA) to prevent ... more OBJECTIVES This study evaluates outcomes of pre-emptive alcohol septal ablation (ASA) to prevent iatrogenic left ventricular outflow tract (LVOT) obstruction after transcatheter mitral valve replacement (TMVR). BACKGROUND LVOT obstruction is a life-threatening complication of TMVR. Bail-out ASA has been described as a therapeutic option for patients with outflow obstruction during TMVR, but little is known about pre-emptive ASA. METHODS Multicenter registry of patients with severe mitral valve disease who underwent pre-emptive ASA to mitigate LVOT obstruction risk after TMVR. High risk of LVOT obstruction was predicted in all patients by pre-procedural computed tomographic imaging. RESULTS Thirty patients (age 76.1 AE 7.7 years; women 76.7%) with severe mitral valve disease underwent pre-emptive ASA to mitigate TMVR-induced LVOT obstruction risk. Twenty patients underwent mitral valve replacement (14 transseptal, 3 transatrial, 1 transapical, 1 transseptal with percutaneous laceration of anterior mitral leaflet, 1 treated with surgical mitral valve replacement). Eight patients experienced clinical improvement post-ASA. Two patients died before TMVR. Median increase in neo-LVOT surface area post-ASA was 111.2 mm 2 (interquartile range: 71.4 to 193.1 mm 2). Five patients (16.7%) required pacemaker implantation post-ASA. In-hospital and 30-day mortality post-ASA was 6.7% (2/30 patients). After ASA, TMVR was performed successfully in 100% of attempted cases. In-hospital and 30-day mortality post-TMVR was 5.3% (1/19). Mortality of entire cohort was 10% (3/30 patients: 2 post-ASA before TMVR, 1 died 30 days post-TMVR). CONCLUSIONS Pre-emptive ASA is associated with a significant increase in predicted neo-LVOT area before TMVR and may enable safe TMVR in patients usually excluded secondary to prohibitive risk of LVOT obstruction.
Journal of the American College of Cardiology, Mar 1, 2019
Background: Protection against acute kidney injury (AKI) has been reported with the use of Impell... more Background: Protection against acute kidney injury (AKI) has been reported with the use of Impella during high-risk percutaneous coronary intervention (HR-PCI). As further validation of both these findings and their clinical applications is lacking, we analyzed the occurrence of AKI in patients from the prospective cVAD study during Impella-supported HR-PCI, compared to the calculated risk score of AKI for these patients. Methods: From 1/2017-3/2018, 1,683 patients were enrolled. Included: 233 that underwent non-emergent HR-PCI supported prior to HR-PCI with Impella 2.5 or Impella CP (Fig.). The primary outcome was post-procedural AKI at 72h compared to the predicted risk of AKI according to Mehran Risk Score. Results: Overall, 6.7% of Impella-supported patients developed AKI (exclusively stage 1) at 72h compared to a predicted rate of 21.9%; representing a 69.5% lower AKI risk (p<0.0001). Patients at high and very high risk of AKI (Mehran Risk Scores 11-16 and ≥16) also experienced significant protection from AKI (9.3% observed AKI incidence vs 26.1% predicted [64.4% lower risk, p=0.0004] and 28.6% vs 57.3% [50% lower risk, p<0.008]; respectively). Predicted rates of AKI were high in patients with normal renal function (18.6%), yet the incidence of AKI was 85.5% lower with Impella protection (p<0.0001). Conclusion: The incidence of AKI during Impella-supported HR-PCI is significantly lower compared to the predicted risk score of AKI in this high risk patient population with low EFs and mod/severe CKD.
Background The MITRAL Trial (Mitral Implantation of TRAnscatheter vaLves) evaluates the safety an... more Background The MITRAL Trial (Mitral Implantation of TRAnscatheter vaLves) evaluates the safety and feasibility of balloon-expandable aortic transcatheter heart valves in patients with severe mitral valve disease with mitral annular calcification (MAC), failed surgical rings or failed bioprostheses. Purpose We sought to evaluate 4-year outcomes of patients enrolled in the MITRAL trial. Methods This is a prospective study that enrolled 91 high surgical risk patients at 13 sites in the U.S. 30 patients underwent Mitral Valve-in-Valve (MViV), 30 Valve-in-Ring (MViR) and 31 Valve-in-MAC (ViMAC). 4-year outcomes of these patients were evaluated in this analysis. Primary endpoints and key serious adverse events including deaths were adjudicated by an independent Clinical Events Committee. Cardiac computed tomography (CT) and echocardiographic images were evaluated by independent CT and Echocardiographic Core Laboratories. Results Mean age was 74.3±8.9 years. Most patients undergoing MViV a...
Background Controversy exists over whether sex has significant interaction with revascularization... more Background Controversy exists over whether sex has significant interaction with revascularization strategy for unprotected left main coronary artery disease. Higher mortality has been reported among women treated with percutaneous coronary intervention compared with coronary artery bypass grafting. Methods and Results The DELTA (Drug‐Eluting Stents for Left Main Coronary Artery Disease) and DELTA‐2 registries are international, multicentric registries evaluating the outcomes of subjects undergoing coronary revascularization for unprotected left main coronary artery disease. The primary outcome was a composite of death, myocardial infarction, or cerebrovascular accidents. The population consisted of 6253 patients, including 1689 (27%) women. Women were older and more likely to have diabetes and chronic kidney disease than men ( P <0.05). At a median follow‐up of 29 months (interquartile range 12–49), a significant interaction between sex and revascularization strategy was observed...
■ Aortic stenosis (AS) is present in 12.4% percent of adults > 75 years of age, of which 3.4% hav... more ■ Aortic stenosis (AS) is present in 12.4% percent of adults > 75 years of age, of which 3.4% have severe AS. The prevalence of AS is projected to continue to increase due to the aging population and absence of therapies to halt its progression [1]. ■ The most common cause of AS is calcific degeneration [2]. ■ Calcific AS was historically felt to be due to age-related degeneration; however, it is due to an active process similar to atherosclerosis that includes lipid deposition, inflammation, and active calcification [3-7]. Severe AS most frequently presents in the sixth to seventh decades of life. ■ Bicuspid aortic valve disease occurs in 1-2% of the general population and is a strong risk factor for the development of AS. − Bicuspid aortic valves (AV) occur more frequently in men (about 2:1) than in women. − Severe AS due to a bicuspid AV can occur earlier in life as compared to with a trileafet AV, most commonly presenting in the fifth and sixth decades of life [8, 9]. ■ Rheumatic AS rarely occurs in the Western world and is most often associated with concomitant mitral pathology. Pathophysiology and Hemodynamics ■ AS is a progressive disease with stages of disease defined by valve anatomy, valve hemodynamics, and symptomatology. − Stage A: Bicuspid AV or AV sclerosis identified, at risk for AS. − Stage B: Mild to moderate AS (see Table 20-1). − Stage C: Hemodynamically significant AS without symptoms. − Stage D: Hemodynamically significant AS with symptoms. − LV hypertrophy occurs in order to maintain normal wall stress (σ) which is proportional to the LV pressure (P) and radius (r) and inversely related to wall thickness (T) as dictated by LaPlace's law: σ = (P * r)/2T. − Normalization of wall stress is a compensatory mechanism that initially preserves LV contractile function. − Progressive AS leads to progressive LV hypertrophy, increased LV systolic pressure and increased LV ejection time, all of which result in increased myocardial oxygen demand. Simultaneously, LV diastolic pressure is increased, aortic pressure is decreased, and diastolic filling time is decreased, resulting in decreased myocardial oxygen supply. The increased myocardial oxygen demand and decreased myocardial oxygen supply lead to myocardial ischemia and ultimately LV failure. AORTIC SCLEROSIS MILD MODERATE SEVERE Aortic jet velocity (m/s) ≤2.5 2.6-2.9 3.0-4.0 ≥4.0 Mean gradient (mm Hg)-<20 20-40 ≥40 AVA (cm 2)->1.5 1.0-1.5 ≤1.0 Indexed AVA (cm 2 /m 2) >0.85 0.60-0.85 ≤0.6 Velocity ratio >0.50 0.25-0.50 <0.25
The aim of this study was to assess 1-year clinical outcomes among high-risk patients with failed... more The aim of this study was to assess 1-year clinical outcomes among high-risk patients with failed surgical mitral bioprostheses who underwent transseptal mitral valve-in-valve (MViV) with the SAPIEN 3 aortic transcatheter heart valve (THV) in the MITRAL (Mitral Implantation of Transcatheter Valves) trial. BACKGROUND The MITRAL trial is the first prospective study evaluating transseptal MViV with the SAPIEN 3 aortic THV in high-risk patients with failed surgical mitral bioprostheses. METHODS High-risk patients with symptomatic moderate to severe or severe mitral regurgitation (MR) or severe mitral stenosis due to failed surgical mitral bioprostheses were prospectively enrolled. The primary safety endpoint was technical success. The primary THV performance endpoint was absence of MR grade $2þ or mean mitral valve gradient $10 mm Hg (30 days and 1 year). Secondary endpoints included procedural success and all-cause mortality (30 days and 1 year). RESULTS Thirty patients were enrolled between July 2016 and October 2017 (median age 77.5 years [interquartile range (IQR): 70.3 to 82.8 years], 63.3% women, median Society of Thoracic Surgeons score 9.4% [IQR: 5.8% to 12.0%], 80% in New York Heart Association functional class III or IV). The technical success rate was 100%. The primary performance endpoint in survivors was achieved in 96.6% (28 of 29) at 30 days and 82.8% (24 of 29) at 1 year. Thirty-day all-cause mortality was 3.3% and was unchanged at 1 year. The only death was due to airway obstruction after swallowing several pills simultaneously 29 days post-MViV. At 1-year follow-up, 89.3% of patients were in New York Heart Association functional class I or II, the median mean mitral valve gradient was 6.6 mm Hg (interquartile range: 5.5 to 8.9 mm Hg), and all patients had MR grade #1þ. CONCLUSIONS Transseptal MViV in high-risk patients was associated with 100% technical success, low procedural complication rates, and very low mortality at 1 year. The vast majority of patients experienced significant symptom alleviation, and THV performance remained stable at 1 year. (
High left ventricular stroke work and low vascular impedance predict better quality of life after... more High left ventricular stroke work and low vascular impedance predict better quality of life after valve intervention in patients with aortic stenosis.
Background: Up to the present, preload reduction in congestive heart failure (CHF) patients is pe... more Background: Up to the present, preload reduction in congestive heart failure (CHF) patients is performed with high potency diuretics. We reported in TCT/ACC 2014 and 2015, the hemodynamic changes of the first 6 CHF case in humans, using Percutaneous Transluminal Caval flow Restriction (PTCR) procedure achived with caval counterpulsation balloon (CCPB). This innovative method reduced preload in CHF. In this study we are reporting the results of the 6 consecutive patients with CHF, treated with intermittent preload reduction of caval flow with CCPB, guided by the respiratory phases. Now we are reporting the echocardiographic of these patients.
The Journal of Heart and Lung Transplantation, 2016
In Japan, living-donor lobar lung transplantation (LDLLT) plays an important role due to the crit... more In Japan, living-donor lobar lung transplantation (LDLLT) plays an important role due to the critical deficit in deceased-donor organs. However, in LDLLT, size matching is pivotal and adult recipients frequently withdraw from LDLLT because of the small size of donor grafts. To solve this critical issue, we recently have developed two novel surgical techniques: sparing native upper lobe and right to left inverted lobar lung transplantation. To date, these new techniques have been performed in 13 cases out of 62 LDLLTs (21%). Either technique was used in 6 cases and both techniques were used only in 1 case. Herein, we report the first case of a successful bilateral LDLLT using these two novel surgical techniques simultaneously. Case Report: A 63-year-old man with end-stage idiopathic interstitial pneumonia was referred to our hospital for the possible candidate for lung transplantation. He was bed bound and his respiratory condition deteriorated day by day. His daughter and sister were the eligible donors for LDLLT. According to Date's formula previously reported (J Thorac Cardiovasc Surg 2003), the estimated forced vital capacity (FVC) of the graft should be > 45-50% of the recipient's predicted FVC. The right lower lobe (RLL) from his daughter and left lower lobe (LLL) from his sister were estimated to provide only 41.7% of the recipient's predicted FVC and the RLLs from the two donors were estimated to provide 46.1%. This meant that the grafts could only provide the borderline size even if we performed bilateral LDLLT using right to left inverted lobar lung transplantation. Therefore, we decided to spare his right upper lobe because the lung perfusion scintigraphy of the recipient showed a right-to-left ratio of 88:12. Chest CT also showed that the right upper lobe looked less damaged. Consequently, we successfully performed bilateral LDLLT by transplanting a RLL graft into the right thorax with sparing the native right upper lobe, and by transplanting an inverted RLL graft into the left thorax. The post-operative course was uneventful. He was discharged on post-operative day 58 without oxygen supplementation. Summary: We report the first case of a successful bilateral LDLLT using two novel surgical techniques: right to left inverted lobar lung transplantation with sparing a native upper lobe.
Journal of the American College of Cardiology, 2016
Objective: The objective of this study was to determine the prevalence of frailty in patients wit... more Objective: The objective of this study was to determine the prevalence of frailty in patients with peripheral arterial disease (PAD) and to compare the incremental value of six non-performance-based frailty scales to predict poor outcomes after interventions for PAD. Methods: FRailty Assessment In Lower Extremity arterial Disease (FRAILED) was a prospective cohort study designed to examine frailty in patients with PAD. Consecutive patients undergoing endovascular or open interventions for PAD (Rutherford class $3) were enrolled. Frailty was assessed using the Edmonton Frailty Scale, FRAIL scale, Groningen Frailty Indicator (GFI), modified Frailty Index, Multidimensional Prognostic Index, and modified Essential Frailty Toolset (mEFT). The primary outcome was a composite of all-cause mortality and morbidity. Results: The cohort consisted of 149 older adults with a mean age of 70.5 6 10.8 years. Patients with claudication and critical ischemia accounted for 40% (n ¼ 60) and 60% (n ¼ 89), respectively. Depending on the scale, the prevalence of frailty ranged from 37% to 70%. The incidence of all-cause mortality was 6.3% in the cohort during a median follow-up of 1.3 years. After adjusting for age, sex, predicted operative risk, diagnosis, and procedure type, the frailty scales with the greatest incremental value for mortality and morbidity were found to be the GFI (standardized adjusted odds ratio, 3.22; 95% confidence interval, 1.32-8.86; Bayesian information criterion, 88.7) and the mEFT (standardized adjusted odds ratio, 1.99; 95% confidence interval, 1.01-3.97; Bayesian information criterion, 93.2). The four other frailty scales were not statistically significant in the multivariable logistic models. Conclusions: The prevalence of frailty and the prognostic impact of frailty varied by the scale used. The GFI and mEFT performed well and were most predictive of mortality and morbidity in patients with PAD undergoing interventions. The GFI and mEFT may be more appropriate to use in clinical practice when assessing frailty in patients with PAD.
Aims: Left ventricular apical ballooning syndrome (LVABS) is a clinical condition of unknown etio... more Aims: Left ventricular apical ballooning syndrome (LVABS) is a clinical condition of unknown etiology, characterized by acute onset of atypical apical wall motion and absence of coronary artery disease. Gadolinium-enhanced cardiac magnetic resonance imaging (Gd-MRI) may be used to identify patients with myocarditis. Using cardiac MRI, we evaluated whether acute myocarditis may be an etiology that underlies LVABS. Methods and Results: Consecutive patients who presented with LVABS during a three-year period were included. Demographic data was recorded and echocardiography, coronary angiography, and hemodynamic assessment performed. Gd-MRI was performed in all patients. The study was deemed consistent with myocarditis when global myocardial to skeletal muscle enhancement ratio was ≥3.5. Regional Gd-MRI analysis was also performed. Patients (n = 11) were female (100%) and of mean age 72 years (72 ± 11). Preceding febrile illness occurred in 4 (36.3%) and leukocytosis in 6 (54.4%) patients. Initial mean left ventricular ejection fraction (41% ± 12%) improved (70.2% ± 8%) upon follow-up (39 ± 43 days). Global MRI analysis was positive in 5/11 (45.5%) (mean relative enhancement ratio 4.8 ± 1.4). Regional MRI analysis was positive in 4/6 further patients (overall: 9/11 (82%)). Conclusions: Gadolinium enhanced MRI imaging in LVABS implicates myocarditis as a possible etiology. Regional MRI analysis adds sensitivity to global cardiac MRI evaluation.
Journal of the American College of Cardiology, 2014
Background: Only few data are available on the impact of mixed aortic stenosis (MAS) on clinical ... more Background: Only few data are available on the impact of mixed aortic stenosis (MAS) on clinical outcomes and post-procedural aortic regurgitation (PPAR) after transcatheter aortic valve implantation (TAVI). The aim of this study was to assess the impact of MAS on PPAR and clinical outcomes after TAVI. Methods: Data from a multicenter registry were retrospectively analysed. Outcomes were compared between patients with pure aortic stenosis (PAS; associated AR < 1+/3+) and MAS (associated AR ! 1+/3+). Study objectives were PPAR incidence and Valve Academic Research Consortium 2 (VARC-2) outcomes at long-term follow-up. Results: In total, 1091 patients were included: 432 (39.5%) with MAS and 659 (60.4%) with PAS. At 30 days, there were no differences in all-cause (6.4% vs. 6.3%; p ¼ 0.930) and cardiovascular mortality (5.5% vs. 4.2%; p ¼ 0.315), however a greater incidence of major bleeding (23% vs. 16.5%; p ¼ 0.011), spontaneous myocardial infarction (2% vs. 0.3%; p ¼ 0.019) and PPAR ! 1+/3+ (43% vs. 27%; p < 0.001) was observed in patients with MAS. Of note, MAS was an independent predictor of PPAR ! 1+/3+ at multivariable analysis. At a median follow-up period of 421 days (IQR 252-710), patients with MAS had a higher all-cause (30% vs. 24%; p ¼ 0.047) and cardiovascular mortality (17% vs. 12%; p ¼ 0.023). Conversely, in patients that developed PPAR ! 2+/3+ the presence of baseline MAS was associated with a trend of lower long-term all-cause and cardiovascular mortality (46% vs. 73%, p ¼ 0.188 and 17% vs. 50%, p ¼ 0.095). Conclusions: MAS was associated with a higher PPAR incidence and increased allcause and cardiovascular mortality when compared to patients with PAS. However, in patients who developed PPAR ! 2+/3+, baseline MAS trended to be associated with improved long-term survival.
Journal of the American College of Cardiology, 2014
background: Right-sided heart failure is an important cause of morbidity in rheumatic mitral sten... more background: Right-sided heart failure is an important cause of morbidity in rheumatic mitral stenosis (MS), and attributed mainly to pulmonary hypertension. Percutaneous mitral valvuloplasty (PMV) effectively reduces pulmonary artery pressure (PAP) but its influence on RV function is unclear. This study evaluated the immediate effects of the PMV on RV function. In addition we sought to identify the determinants of the RV function post PMV and the impact of RV function post PMV on long-term clinical outcome. methods: Patients with symptomatic MS who underwent PMV (2000-2013) at 2 centers were recruited. A range of invasive hemodynamic and echocardiographic measures (pre and 24 hours post PMV) were collected. RV function was assessed by RV fractional area change (RVFAC). Longterm outcome was a composite endpoint of death, mitral valve (MV) replacement or repeat PMV.
Background: Coronary perforations represent a serious complication of percutaneous coronary inter... more Background: Coronary perforations represent a serious complication of percutaneous coronary intervention (PCI). Methods: We performed a retrospective analysis of documented coronary perforations at Massachusetts General Hospital from 2000 to 2008. Medical records review and detailed angiographic analysis were performed in all patients.
Emerging metabolomic tools have created the opportunity to establish metabolic signatures of myoc... more Emerging metabolomic tools have created the opportunity to establish metabolic signatures of myocardial injury. We applied a mass spectrometry-based metabolite profiling platform to 36 patients undergoing alcohol septal ablation treatment for hypertrophic obstructive cardiomyopathy, a human model of planned myocardial infarction (PMI). Serial blood samples were obtained before and at various intervals after PMI, with patients undergoing elective diagnostic coronary angiography and patients with spontaneous myocardial infarction (SMI) serving as negative and positive controls, respectively. We identified changes in circulating levels of metabolites participating in pyrimidine metabolism, the tricarboxylic acid cycle and its upstream contributors, and the pentose phosphate pathway. Alterations in levels of multiple metabolites were detected as early as 10 minutes after PMI in an initial derivation group and were validated in a second, independent group of PMI patients. A PMI-derived metabolic signature consisting of aconitic acid, hypoxanthine, trimethylamine N-oxide, and threonine differentiated patients with SMI from those undergoing diagnostic coronary angiography with high accuracy, and coronary sinus sampling distinguished cardiac-derived from peripheral metabolic changes. Our results identify a role for metabolic profiling in the early detection of myocardial injury and suggest that similar approaches may be used for detection or prediction of other disease states.
Background The optimal revascularization strategy of women with unprotected left main coronary ar... more Background The optimal revascularization strategy of women with unprotected left main coronary artery (ULMCA) disease is unknown. Therefore, the aim of this study was to evaluate longterm clinical outcomes in this cohort treated with percutaneous coronary intervention (PCI) utilising drug-eluting stents (DES) versus coronary artery bypass grafting (CABG).
Percutaneous access of the pericardial space is increasingly sought. This is not only due to grow... more Percutaneous access of the pericardial space is increasingly sought. This is not only due to growing prevalence of pericardial effusions and cardiac tamponade, but also the emerging diagnostic and therapeutic potential of the pericardial space for mapping and ablation of arrhythmogenic circuits, biopsy, and drug delivery. Although increasingly performed, percutaneous pericardiocentesis remains a technically challenging procedure with potentially life-threatening complications. Consequently, management of patients with pericardial disease is highly complex. In this chapter we outline a step-by-step approach to percutaneous pericardiocentesis and the required specialised management of pericardial disease patients. Procedural complications are discussed along with their alleviating therapeutic strategies. Furthermore, we describe approaches to the prevention and management of recurrent pericardial effusion including diagnostic and therapeutic procedures such as percutaneous balloon pericardiotomy and intra-pericardial delivery of chemotherapeutics and sclerosing agents.
OBJECTIVES This study evaluates outcomes of pre-emptive alcohol septal ablation (ASA) to prevent ... more OBJECTIVES This study evaluates outcomes of pre-emptive alcohol septal ablation (ASA) to prevent iatrogenic left ventricular outflow tract (LVOT) obstruction after transcatheter mitral valve replacement (TMVR). BACKGROUND LVOT obstruction is a life-threatening complication of TMVR. Bail-out ASA has been described as a therapeutic option for patients with outflow obstruction during TMVR, but little is known about pre-emptive ASA. METHODS Multicenter registry of patients with severe mitral valve disease who underwent pre-emptive ASA to mitigate LVOT obstruction risk after TMVR. High risk of LVOT obstruction was predicted in all patients by pre-procedural computed tomographic imaging. RESULTS Thirty patients (age 76.1 AE 7.7 years; women 76.7%) with severe mitral valve disease underwent pre-emptive ASA to mitigate TMVR-induced LVOT obstruction risk. Twenty patients underwent mitral valve replacement (14 transseptal, 3 transatrial, 1 transapical, 1 transseptal with percutaneous laceration of anterior mitral leaflet, 1 treated with surgical mitral valve replacement). Eight patients experienced clinical improvement post-ASA. Two patients died before TMVR. Median increase in neo-LVOT surface area post-ASA was 111.2 mm 2 (interquartile range: 71.4 to 193.1 mm 2). Five patients (16.7%) required pacemaker implantation post-ASA. In-hospital and 30-day mortality post-ASA was 6.7% (2/30 patients). After ASA, TMVR was performed successfully in 100% of attempted cases. In-hospital and 30-day mortality post-TMVR was 5.3% (1/19). Mortality of entire cohort was 10% (3/30 patients: 2 post-ASA before TMVR, 1 died 30 days post-TMVR). CONCLUSIONS Pre-emptive ASA is associated with a significant increase in predicted neo-LVOT area before TMVR and may enable safe TMVR in patients usually excluded secondary to prohibitive risk of LVOT obstruction.
Journal of the American College of Cardiology, Mar 1, 2019
Background: Protection against acute kidney injury (AKI) has been reported with the use of Impell... more Background: Protection against acute kidney injury (AKI) has been reported with the use of Impella during high-risk percutaneous coronary intervention (HR-PCI). As further validation of both these findings and their clinical applications is lacking, we analyzed the occurrence of AKI in patients from the prospective cVAD study during Impella-supported HR-PCI, compared to the calculated risk score of AKI for these patients. Methods: From 1/2017-3/2018, 1,683 patients were enrolled. Included: 233 that underwent non-emergent HR-PCI supported prior to HR-PCI with Impella 2.5 or Impella CP (Fig.). The primary outcome was post-procedural AKI at 72h compared to the predicted risk of AKI according to Mehran Risk Score. Results: Overall, 6.7% of Impella-supported patients developed AKI (exclusively stage 1) at 72h compared to a predicted rate of 21.9%; representing a 69.5% lower AKI risk (p<0.0001). Patients at high and very high risk of AKI (Mehran Risk Scores 11-16 and ≥16) also experienced significant protection from AKI (9.3% observed AKI incidence vs 26.1% predicted [64.4% lower risk, p=0.0004] and 28.6% vs 57.3% [50% lower risk, p<0.008]; respectively). Predicted rates of AKI were high in patients with normal renal function (18.6%), yet the incidence of AKI was 85.5% lower with Impella protection (p<0.0001). Conclusion: The incidence of AKI during Impella-supported HR-PCI is significantly lower compared to the predicted risk score of AKI in this high risk patient population with low EFs and mod/severe CKD.
Background The MITRAL Trial (Mitral Implantation of TRAnscatheter vaLves) evaluates the safety an... more Background The MITRAL Trial (Mitral Implantation of TRAnscatheter vaLves) evaluates the safety and feasibility of balloon-expandable aortic transcatheter heart valves in patients with severe mitral valve disease with mitral annular calcification (MAC), failed surgical rings or failed bioprostheses. Purpose We sought to evaluate 4-year outcomes of patients enrolled in the MITRAL trial. Methods This is a prospective study that enrolled 91 high surgical risk patients at 13 sites in the U.S. 30 patients underwent Mitral Valve-in-Valve (MViV), 30 Valve-in-Ring (MViR) and 31 Valve-in-MAC (ViMAC). 4-year outcomes of these patients were evaluated in this analysis. Primary endpoints and key serious adverse events including deaths were adjudicated by an independent Clinical Events Committee. Cardiac computed tomography (CT) and echocardiographic images were evaluated by independent CT and Echocardiographic Core Laboratories. Results Mean age was 74.3±8.9 years. Most patients undergoing MViV a...
Background Controversy exists over whether sex has significant interaction with revascularization... more Background Controversy exists over whether sex has significant interaction with revascularization strategy for unprotected left main coronary artery disease. Higher mortality has been reported among women treated with percutaneous coronary intervention compared with coronary artery bypass grafting. Methods and Results The DELTA (Drug‐Eluting Stents for Left Main Coronary Artery Disease) and DELTA‐2 registries are international, multicentric registries evaluating the outcomes of subjects undergoing coronary revascularization for unprotected left main coronary artery disease. The primary outcome was a composite of death, myocardial infarction, or cerebrovascular accidents. The population consisted of 6253 patients, including 1689 (27%) women. Women were older and more likely to have diabetes and chronic kidney disease than men ( P <0.05). At a median follow‐up of 29 months (interquartile range 12–49), a significant interaction between sex and revascularization strategy was observed...
■ Aortic stenosis (AS) is present in 12.4% percent of adults > 75 years of age, of which 3.4% hav... more ■ Aortic stenosis (AS) is present in 12.4% percent of adults > 75 years of age, of which 3.4% have severe AS. The prevalence of AS is projected to continue to increase due to the aging population and absence of therapies to halt its progression [1]. ■ The most common cause of AS is calcific degeneration [2]. ■ Calcific AS was historically felt to be due to age-related degeneration; however, it is due to an active process similar to atherosclerosis that includes lipid deposition, inflammation, and active calcification [3-7]. Severe AS most frequently presents in the sixth to seventh decades of life. ■ Bicuspid aortic valve disease occurs in 1-2% of the general population and is a strong risk factor for the development of AS. − Bicuspid aortic valves (AV) occur more frequently in men (about 2:1) than in women. − Severe AS due to a bicuspid AV can occur earlier in life as compared to with a trileafet AV, most commonly presenting in the fifth and sixth decades of life [8, 9]. ■ Rheumatic AS rarely occurs in the Western world and is most often associated with concomitant mitral pathology. Pathophysiology and Hemodynamics ■ AS is a progressive disease with stages of disease defined by valve anatomy, valve hemodynamics, and symptomatology. − Stage A: Bicuspid AV or AV sclerosis identified, at risk for AS. − Stage B: Mild to moderate AS (see Table 20-1). − Stage C: Hemodynamically significant AS without symptoms. − Stage D: Hemodynamically significant AS with symptoms. − LV hypertrophy occurs in order to maintain normal wall stress (σ) which is proportional to the LV pressure (P) and radius (r) and inversely related to wall thickness (T) as dictated by LaPlace's law: σ = (P * r)/2T. − Normalization of wall stress is a compensatory mechanism that initially preserves LV contractile function. − Progressive AS leads to progressive LV hypertrophy, increased LV systolic pressure and increased LV ejection time, all of which result in increased myocardial oxygen demand. Simultaneously, LV diastolic pressure is increased, aortic pressure is decreased, and diastolic filling time is decreased, resulting in decreased myocardial oxygen supply. The increased myocardial oxygen demand and decreased myocardial oxygen supply lead to myocardial ischemia and ultimately LV failure. AORTIC SCLEROSIS MILD MODERATE SEVERE Aortic jet velocity (m/s) ≤2.5 2.6-2.9 3.0-4.0 ≥4.0 Mean gradient (mm Hg)-<20 20-40 ≥40 AVA (cm 2)->1.5 1.0-1.5 ≤1.0 Indexed AVA (cm 2 /m 2) >0.85 0.60-0.85 ≤0.6 Velocity ratio >0.50 0.25-0.50 <0.25
The aim of this study was to assess 1-year clinical outcomes among high-risk patients with failed... more The aim of this study was to assess 1-year clinical outcomes among high-risk patients with failed surgical mitral bioprostheses who underwent transseptal mitral valve-in-valve (MViV) with the SAPIEN 3 aortic transcatheter heart valve (THV) in the MITRAL (Mitral Implantation of Transcatheter Valves) trial. BACKGROUND The MITRAL trial is the first prospective study evaluating transseptal MViV with the SAPIEN 3 aortic THV in high-risk patients with failed surgical mitral bioprostheses. METHODS High-risk patients with symptomatic moderate to severe or severe mitral regurgitation (MR) or severe mitral stenosis due to failed surgical mitral bioprostheses were prospectively enrolled. The primary safety endpoint was technical success. The primary THV performance endpoint was absence of MR grade $2þ or mean mitral valve gradient $10 mm Hg (30 days and 1 year). Secondary endpoints included procedural success and all-cause mortality (30 days and 1 year). RESULTS Thirty patients were enrolled between July 2016 and October 2017 (median age 77.5 years [interquartile range (IQR): 70.3 to 82.8 years], 63.3% women, median Society of Thoracic Surgeons score 9.4% [IQR: 5.8% to 12.0%], 80% in New York Heart Association functional class III or IV). The technical success rate was 100%. The primary performance endpoint in survivors was achieved in 96.6% (28 of 29) at 30 days and 82.8% (24 of 29) at 1 year. Thirty-day all-cause mortality was 3.3% and was unchanged at 1 year. The only death was due to airway obstruction after swallowing several pills simultaneously 29 days post-MViV. At 1-year follow-up, 89.3% of patients were in New York Heart Association functional class I or II, the median mean mitral valve gradient was 6.6 mm Hg (interquartile range: 5.5 to 8.9 mm Hg), and all patients had MR grade #1þ. CONCLUSIONS Transseptal MViV in high-risk patients was associated with 100% technical success, low procedural complication rates, and very low mortality at 1 year. The vast majority of patients experienced significant symptom alleviation, and THV performance remained stable at 1 year. (
High left ventricular stroke work and low vascular impedance predict better quality of life after... more High left ventricular stroke work and low vascular impedance predict better quality of life after valve intervention in patients with aortic stenosis.
Background: Up to the present, preload reduction in congestive heart failure (CHF) patients is pe... more Background: Up to the present, preload reduction in congestive heart failure (CHF) patients is performed with high potency diuretics. We reported in TCT/ACC 2014 and 2015, the hemodynamic changes of the first 6 CHF case in humans, using Percutaneous Transluminal Caval flow Restriction (PTCR) procedure achived with caval counterpulsation balloon (CCPB). This innovative method reduced preload in CHF. In this study we are reporting the results of the 6 consecutive patients with CHF, treated with intermittent preload reduction of caval flow with CCPB, guided by the respiratory phases. Now we are reporting the echocardiographic of these patients.
The Journal of Heart and Lung Transplantation, 2016
In Japan, living-donor lobar lung transplantation (LDLLT) plays an important role due to the crit... more In Japan, living-donor lobar lung transplantation (LDLLT) plays an important role due to the critical deficit in deceased-donor organs. However, in LDLLT, size matching is pivotal and adult recipients frequently withdraw from LDLLT because of the small size of donor grafts. To solve this critical issue, we recently have developed two novel surgical techniques: sparing native upper lobe and right to left inverted lobar lung transplantation. To date, these new techniques have been performed in 13 cases out of 62 LDLLTs (21%). Either technique was used in 6 cases and both techniques were used only in 1 case. Herein, we report the first case of a successful bilateral LDLLT using these two novel surgical techniques simultaneously. Case Report: A 63-year-old man with end-stage idiopathic interstitial pneumonia was referred to our hospital for the possible candidate for lung transplantation. He was bed bound and his respiratory condition deteriorated day by day. His daughter and sister were the eligible donors for LDLLT. According to Date's formula previously reported (J Thorac Cardiovasc Surg 2003), the estimated forced vital capacity (FVC) of the graft should be > 45-50% of the recipient's predicted FVC. The right lower lobe (RLL) from his daughter and left lower lobe (LLL) from his sister were estimated to provide only 41.7% of the recipient's predicted FVC and the RLLs from the two donors were estimated to provide 46.1%. This meant that the grafts could only provide the borderline size even if we performed bilateral LDLLT using right to left inverted lobar lung transplantation. Therefore, we decided to spare his right upper lobe because the lung perfusion scintigraphy of the recipient showed a right-to-left ratio of 88:12. Chest CT also showed that the right upper lobe looked less damaged. Consequently, we successfully performed bilateral LDLLT by transplanting a RLL graft into the right thorax with sparing the native right upper lobe, and by transplanting an inverted RLL graft into the left thorax. The post-operative course was uneventful. He was discharged on post-operative day 58 without oxygen supplementation. Summary: We report the first case of a successful bilateral LDLLT using two novel surgical techniques: right to left inverted lobar lung transplantation with sparing a native upper lobe.
Journal of the American College of Cardiology, 2016
Objective: The objective of this study was to determine the prevalence of frailty in patients wit... more Objective: The objective of this study was to determine the prevalence of frailty in patients with peripheral arterial disease (PAD) and to compare the incremental value of six non-performance-based frailty scales to predict poor outcomes after interventions for PAD. Methods: FRailty Assessment In Lower Extremity arterial Disease (FRAILED) was a prospective cohort study designed to examine frailty in patients with PAD. Consecutive patients undergoing endovascular or open interventions for PAD (Rutherford class $3) were enrolled. Frailty was assessed using the Edmonton Frailty Scale, FRAIL scale, Groningen Frailty Indicator (GFI), modified Frailty Index, Multidimensional Prognostic Index, and modified Essential Frailty Toolset (mEFT). The primary outcome was a composite of all-cause mortality and morbidity. Results: The cohort consisted of 149 older adults with a mean age of 70.5 6 10.8 years. Patients with claudication and critical ischemia accounted for 40% (n ¼ 60) and 60% (n ¼ 89), respectively. Depending on the scale, the prevalence of frailty ranged from 37% to 70%. The incidence of all-cause mortality was 6.3% in the cohort during a median follow-up of 1.3 years. After adjusting for age, sex, predicted operative risk, diagnosis, and procedure type, the frailty scales with the greatest incremental value for mortality and morbidity were found to be the GFI (standardized adjusted odds ratio, 3.22; 95% confidence interval, 1.32-8.86; Bayesian information criterion, 88.7) and the mEFT (standardized adjusted odds ratio, 1.99; 95% confidence interval, 1.01-3.97; Bayesian information criterion, 93.2). The four other frailty scales were not statistically significant in the multivariable logistic models. Conclusions: The prevalence of frailty and the prognostic impact of frailty varied by the scale used. The GFI and mEFT performed well and were most predictive of mortality and morbidity in patients with PAD undergoing interventions. The GFI and mEFT may be more appropriate to use in clinical practice when assessing frailty in patients with PAD.
Aims: Left ventricular apical ballooning syndrome (LVABS) is a clinical condition of unknown etio... more Aims: Left ventricular apical ballooning syndrome (LVABS) is a clinical condition of unknown etiology, characterized by acute onset of atypical apical wall motion and absence of coronary artery disease. Gadolinium-enhanced cardiac magnetic resonance imaging (Gd-MRI) may be used to identify patients with myocarditis. Using cardiac MRI, we evaluated whether acute myocarditis may be an etiology that underlies LVABS. Methods and Results: Consecutive patients who presented with LVABS during a three-year period were included. Demographic data was recorded and echocardiography, coronary angiography, and hemodynamic assessment performed. Gd-MRI was performed in all patients. The study was deemed consistent with myocarditis when global myocardial to skeletal muscle enhancement ratio was ≥3.5. Regional Gd-MRI analysis was also performed. Patients (n = 11) were female (100%) and of mean age 72 years (72 ± 11). Preceding febrile illness occurred in 4 (36.3%) and leukocytosis in 6 (54.4%) patients. Initial mean left ventricular ejection fraction (41% ± 12%) improved (70.2% ± 8%) upon follow-up (39 ± 43 days). Global MRI analysis was positive in 5/11 (45.5%) (mean relative enhancement ratio 4.8 ± 1.4). Regional MRI analysis was positive in 4/6 further patients (overall: 9/11 (82%)). Conclusions: Gadolinium enhanced MRI imaging in LVABS implicates myocarditis as a possible etiology. Regional MRI analysis adds sensitivity to global cardiac MRI evaluation.
Journal of the American College of Cardiology, 2014
Background: Only few data are available on the impact of mixed aortic stenosis (MAS) on clinical ... more Background: Only few data are available on the impact of mixed aortic stenosis (MAS) on clinical outcomes and post-procedural aortic regurgitation (PPAR) after transcatheter aortic valve implantation (TAVI). The aim of this study was to assess the impact of MAS on PPAR and clinical outcomes after TAVI. Methods: Data from a multicenter registry were retrospectively analysed. Outcomes were compared between patients with pure aortic stenosis (PAS; associated AR < 1+/3+) and MAS (associated AR ! 1+/3+). Study objectives were PPAR incidence and Valve Academic Research Consortium 2 (VARC-2) outcomes at long-term follow-up. Results: In total, 1091 patients were included: 432 (39.5%) with MAS and 659 (60.4%) with PAS. At 30 days, there were no differences in all-cause (6.4% vs. 6.3%; p ¼ 0.930) and cardiovascular mortality (5.5% vs. 4.2%; p ¼ 0.315), however a greater incidence of major bleeding (23% vs. 16.5%; p ¼ 0.011), spontaneous myocardial infarction (2% vs. 0.3%; p ¼ 0.019) and PPAR ! 1+/3+ (43% vs. 27%; p < 0.001) was observed in patients with MAS. Of note, MAS was an independent predictor of PPAR ! 1+/3+ at multivariable analysis. At a median follow-up period of 421 days (IQR 252-710), patients with MAS had a higher all-cause (30% vs. 24%; p ¼ 0.047) and cardiovascular mortality (17% vs. 12%; p ¼ 0.023). Conversely, in patients that developed PPAR ! 2+/3+ the presence of baseline MAS was associated with a trend of lower long-term all-cause and cardiovascular mortality (46% vs. 73%, p ¼ 0.188 and 17% vs. 50%, p ¼ 0.095). Conclusions: MAS was associated with a higher PPAR incidence and increased allcause and cardiovascular mortality when compared to patients with PAS. However, in patients who developed PPAR ! 2+/3+, baseline MAS trended to be associated with improved long-term survival.
Journal of the American College of Cardiology, 2014
background: Right-sided heart failure is an important cause of morbidity in rheumatic mitral sten... more background: Right-sided heart failure is an important cause of morbidity in rheumatic mitral stenosis (MS), and attributed mainly to pulmonary hypertension. Percutaneous mitral valvuloplasty (PMV) effectively reduces pulmonary artery pressure (PAP) but its influence on RV function is unclear. This study evaluated the immediate effects of the PMV on RV function. In addition we sought to identify the determinants of the RV function post PMV and the impact of RV function post PMV on long-term clinical outcome. methods: Patients with symptomatic MS who underwent PMV (2000-2013) at 2 centers were recruited. A range of invasive hemodynamic and echocardiographic measures (pre and 24 hours post PMV) were collected. RV function was assessed by RV fractional area change (RVFAC). Longterm outcome was a composite endpoint of death, mitral valve (MV) replacement or repeat PMV.
Background: Coronary perforations represent a serious complication of percutaneous coronary inter... more Background: Coronary perforations represent a serious complication of percutaneous coronary intervention (PCI). Methods: We performed a retrospective analysis of documented coronary perforations at Massachusetts General Hospital from 2000 to 2008. Medical records review and detailed angiographic analysis were performed in all patients.
Emerging metabolomic tools have created the opportunity to establish metabolic signatures of myoc... more Emerging metabolomic tools have created the opportunity to establish metabolic signatures of myocardial injury. We applied a mass spectrometry-based metabolite profiling platform to 36 patients undergoing alcohol septal ablation treatment for hypertrophic obstructive cardiomyopathy, a human model of planned myocardial infarction (PMI). Serial blood samples were obtained before and at various intervals after PMI, with patients undergoing elective diagnostic coronary angiography and patients with spontaneous myocardial infarction (SMI) serving as negative and positive controls, respectively. We identified changes in circulating levels of metabolites participating in pyrimidine metabolism, the tricarboxylic acid cycle and its upstream contributors, and the pentose phosphate pathway. Alterations in levels of multiple metabolites were detected as early as 10 minutes after PMI in an initial derivation group and were validated in a second, independent group of PMI patients. A PMI-derived metabolic signature consisting of aconitic acid, hypoxanthine, trimethylamine N-oxide, and threonine differentiated patients with SMI from those undergoing diagnostic coronary angiography with high accuracy, and coronary sinus sampling distinguished cardiac-derived from peripheral metabolic changes. Our results identify a role for metabolic profiling in the early detection of myocardial injury and suggest that similar approaches may be used for detection or prediction of other disease states.
Background The optimal revascularization strategy of women with unprotected left main coronary ar... more Background The optimal revascularization strategy of women with unprotected left main coronary artery (ULMCA) disease is unknown. Therefore, the aim of this study was to evaluate longterm clinical outcomes in this cohort treated with percutaneous coronary intervention (PCI) utilising drug-eluting stents (DES) versus coronary artery bypass grafting (CABG).
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Papers by Igor Palacios