Fate of Hypoplastic Pulmonary Arteries After Arterial Duct Stenting in Congenital Heart Disease With Duct-Dependent Pulmonary Circulation

ObjectivesThis study sought to evaluate the impact of arterial duct (AD) stenting in promoting catch-up growth of hypoplastic pulmonary artery (PA) tree in congenital heart disease with duct-dependent pulmonary circulation (CHD-DPC).BackgroundSignificant and balanced PA growth following AD stenting has already been consistently reported in the literature. However, no data are so far available about the role of this approach in severe PA hypoplasia, which significantly impacts the risk of surgical repair.MethodsPre-surgical angiographic PA evaluation was performed in 45 patients with confluent PAs submitted to neonatal AD stenting as palliation of CHD-DPC. PA growth was evaluated as Nakata Index and McGoon ratio as well as individual PA z-score changes, both in the whole population and according to the original vessel size (Nakata Index <100 mm²/m², Group I [n = 15] vs. Nakata Index >100 mm²/m², Group II [n = 30]).ResultsControl angiography was performed 7.5 ± 6.5 months (median 6 months) after duct stenting, showing significant and balanced PA growth. The Nakata Index increased from 143 ± 73 mm²/m² to 270 ± 88 mm²/m² (124 ± 118%, p < 0.0001); left PA z-score from −0.7 ± 1.7 to 1.0 ± 1.4; right PA z-score from −0.6 ± 1.3 to 1.2 ± 1.3 (p < 0.0001 for both comparisons). Group I showed a greater increase of global PA growth (Nakata Index increase 227 ± 141% vs. 72 ± 57%, p < 0.001) as compared with Group II. Final PA size did not significantly differ between the groups (246 ± 105 mm²/m² vs. 282 ± 78 mm²/m², p = NS).ConclusionsPercutaneous AD stenting is highly effective in promoting a significant and balanced catch-up growth of diminutive PAs, being therefore advisable in this subset of patients as a reliable alternative to surgical palliation.     

Persistence of Iatrogenic Atrial Septal Defect After Interventional Mitral Valve Repair With the MitraClip System: A Note of Caution

ObjectivesThe purpose of this study was to investigate the persistence rates of iatrogenic atrial septal defect (iASD) after interventional edge-to-edge repair with serial transesophageal echocardiography examinations and close clinical follow-up (FU).BackgroundTranscatheter mitral valve repair (TMVR) with the MitraClip system (Abbott Vascular, Abbott Park, Illinois) is a therapeutic alternative to surgery in selected high-risk patients. Clip placement requires interatrial transseptal puncture and meticulous manipulation of the steerable sheath. The persistence of iASD after MitraClip procedures and its clinical relevance is unknown.MethodsA total of 66 patients (76.7% male, mean age 77.1 ± 7.9 years) with symptomatic mitral regurgitation (MR) at prohibitive surgical risk (EuroSCORE II 10.1 ± 6.1%) underwent MitraClip procedures and completed 6 months of FU.ResultsTransesophageal echocardiography after FU showed persistent iASD in 50% of cases. Patients with iASD did not significantly differ from patients without ASD concerning baseline characteristics, New York Heart Association functional class, severity of MR, and acute procedural success rates (p > 0.05). When comparing procedural details and hemodynamic measures between groups, MitraClip procedures took longer in patients without iASD (82.4 ± 39.7 min vs. 68.9 ± 45.5 min; p = 0.05), and echocardiography after FU showed less decrease of systolic pulmonary artery pressures in the iASD group (−1.6 ± 14.1 mm Hg vs. 9.3 ± 17.4 mm Hg; p = 0.02). Clinically, patients with iASD presented more often with New York Heart Association functional classes >II after FU (57% vs. 30%; p = 0.04), showed higher levels of N-terminal pro-brain natriuretic peptide (6,667.3 ± 7,363.9 ng/dl vs. 4,835.9 ± 6,681.7 ng/dl; p = 0.05), and had less improvement in 6-min walking distances (20.8 ± 107.4 m vs. 114.6 ± 116.4 m; p = 0.001). Patients with iASD showed higher death rates during 6 months (16.6% vs. 3.3%; p = 0.05). Cox regression analysis found that only persistence of iASD (p = 0.04) was associated with 6-month survival.ConclusionsThe persistence rate of 50% iASD after MitraClip procedures is considerably high. Persistent interatrial shunting was associated with worse clinical outcomes and increased mortality. Further studies are warranted to investigate if persistent interatrial shunting is the mediator or marker of advanced disease in these patients.     

Pressure-Wire-Guided Percutaneous Transluminal Pulmonary Angioplasty: A Breakthrough in Catheter-Interventional Therapy for Chronic Thromboembolic Pulmonary Hypertension

ObjectivesThis study sought to prove the safety and effectiveness of pressure-wire-guided percutaneous transluminal pulmonary angioplasty (PTPA).BackgroundPTPA has been demonstrated to be effective for treatment of chronic thromboembolic pulmonary hypertension. However, a major and occasionally fatal complication after PTPA is reperfusion pulmonary edema. To avoid this, we developed the PEPSI (Pulmonary Edema Predictive Scoring Index). The pressure wire has been used to detect insufficiency of flow in a vessel.MethodsWe included 350 consecutive PTPA sessions in 103 patients with chronic thromboembolic pulmonary hypertension from January 1, 2009 to December 31, 2013. During these 5 years, 140 PTPA sessions were performed without guidance, 65 with guidance of PEPSI alone, and 145 with both PEPSI and pressure-wire guidance. Each PTPA session was finished after achieving PEPSI scores of <35.4 with PEPSI guidance and each target lesion achieving distal mean pulmonary arterial pressure <35 mm Hg with pressure-wire guidance.ResultsThe occurrence of clinically critical reperfusion pulmonary edema and vessel injuries were lowest in the group using the guidance of both pressure wire and PEPSI (0% and 6.9%, respectively). Furthermore, the group guided by pressure wire and PEPSI accomplished the same hemodynamic improvements with fewer numbers of target lesions treated and sessions performed.ConclusionsThe combined approach using pressure wire and PEPSI produced more efficient clinical results and greatly reduced reperfusion pulmonary edema and vessel complications. This is further evidence that PTPA is an alternative strategy for treating chronic thromboembolic pulmonary hypertension.     

Transcatheter Pulmonary Valve Replacement With the Edwards Sapien System: The Toronto Experience

ObjectivesThis study sought to review the outcomes for the Sapien and Sapien XT valves (Edwards Lifesciences, Irvine, California) for percutaneous pulmonary valve implantation (PPVI).BackgroundPPVI has emerged as a viable alternative to surgery in patients with right ventricular (RV) outflow tract dysfunction. Limited data are available for the Sapien and Sapien XT valves in this setting.MethodsRetrospective analysis was performed for all patients to have undergone PPVI using the Edwards Sapien system at a large quaternary center.ResultsTwenty-five patients (70% male, mean age 34 ± 8.9 years) were identified. Primary underlying diagnosis was tetralogy of Fallot (n = 15), Ross procedure (n = 5), and other (n = 5). RV outflow tract characteristics included: biological valve (n = 16) and homograft (n = 9). Technical success was 96%. One patient required elective surgical pulmonary valve replacement for a high residual gradient. Pre-stenting was performed in all cases (52% covered stents). Valve sizes were 23 mm (n = 8), 26 mm (n = 15), and 29 mm (n = 2). Procedural hemodynamics revealed a decrease in the mean RV-to-systemic pressure ratio from 0.64 to 0.36 (p < 0.001) and RV-to-pulmonary artery (PA) gradient from 39 to 9 mm Hg (p < 0.001). No patient had clinically significant pulmonary regurgitation (PR). At a mean follow-up of 3.5 ± 2.1 years (range 0.3 to 7.2 years), there were no deaths. One patient required reintervention (no PR evident immediately post-procedure but severe valvular PR at 1 year requiring a valve-in-valve procedure). There were no episodes of endocarditis and no stent fractures. There was preserved valve function during follow-up with no change in RV-to-PA gradient nor PR severity.ConclusionsThe Edwards Sapien system is a viable and durable option for PPVI in this single-center study.     

Predictors of Carotid Occlusion Intolerance During Proximal Protected Carotid Artery Stenting

ObjectivesThe aim of this study was to identify predictors of occlusion intolerance (OI) developing during proximal protected carotid artery stenting (CAS).BackgroundThe use of proximal embolic protection devices, such as endovascular occlusion, during CAS has been demonstrated to be particularly safe and effective. However, endovascular occlusion can expose the ipsilateral hemisphere to hypoperfusion and produce transient neurological symptoms (OI).MethodsFrom March 2010 to March 2012, 605 consecutive patients underwent proximal protected CAS at our institution. To identify independent predictors of OI, a multivariate logistic regression model was developed that included all patients’ clinical/angiographic and procedural characteristics.ResultsOI developed in a total of 184 patients (30.4%). Compared with patients in whom OI did not develop, those who experienced OI had lower occlusion pressure (OP) (42.3 ± 12.7 mm Hg vs. 61.9 ± 15.4 mm Hg, p < 0.001). Receiver-operating characteristic curve analysis demonstrated that OP was the most consistent predictor of OI with a C-statistic of 0.85 (95% confidence interval [CI]: 0.82 to 0.88) with best cutoff being ≤40 mm Hg (sensitivity, 68.5%; specificity, 93.3%). By logistic regression analysis, the most powerful independent predictor of OI developing was an OP ≤40 mm Hg (odds ratio: 33.2, 95% CI: 19.1 to 57.7) and the most powerful clinical predictor of such OP was the presence of contralateral internal carotid artery occlusion (odds ratio: 3.1, 95% CI: 1.5 to 6.2).ConclusionsOI may occur in as many as one-third of the patients undergoing proximal protected CAS. This event is more common in those patients with an OP ≤40 mm Hg. Patients presenting with concomitant occlusion of the contralateral internal carotid artery more frequently have an OP ≤40 mm Hg.     

Prognostic Value of RV Function Before and After Lung Transplantation

ObjectivesWe investigated the effects of lung transplantation on right ventricular (RV) function as well as the prognostic value of pre- and post-transplantation RV function.BackgroundAlthough lung transplantation success has improved over recent decades, outcomes remain a challenge. Identifying predictors of mortality in lung transplant recipients may lead to improved long-term outcomes after lung transplantation.MethodsEighty-nine (age 60 ± 6 years, 58 men) consecutive patients who underwent single or double lung transplantation and had pre- and post-transplantation echocardiograms between July 2001 and August 2012 were evaluated. Echocardiographic measurements were performed before and after lung transplantation. Left ventricular (LV) and RV longitudinal strains were analyzed using velocity vector imaging. Cox proportional prognostic hazard models predicting all-cause death were built.ResultsThere were 46 all-cause (52%) and 17 cardiac (19%) deaths during 43 ± 33 months of follow-up. After lung transplantation, echocardiography showed improved systolic pulmonary artery pressure (SPAP) (50 ± 19 mm Hg to 40 ± 13 mm Hg) and RV strain (−17 ± 5% to −18 ± 4%). No pre-transplantation RV parameter predicted all-cause mortality. After adjustment for age, sex, surgery type, and etiology of lung disease in a Cox proportional hazards model, both post-transplantation RV strain (hazard ratio: 1.13, 95% confidence interval: 1.04 to 1.23, p = 0.005), and post-transplantation SPAP (hazard ratio: 1.03, 95% confidence interval: 1.01 to 1.05, p = 0.011) were independent predictors of all-cause mortality. When post-transplantation RV strain and post-transplantation SPAP were added the clinical predictive model based on age, sex, surgery type, and etiology, the C-statistic improves from 0.60 to 0.80 (p = 0.002).ConclusionsAlterations of RV function and pulmonary artery pressure normalize, and post-transplantation RV function may provide prognostic data in patients after lung transplantation. Our study is based on a highly and retrospectively selected group. We believe that larger prospective studies are warranted to confirm this result.     

Zero-Flow Pressure Measured Immediately After Primary Percutaneous Coronary Intervention for ST-Segment Elevation Myocardial Infarction Provides the Best Invasive Index for Predicting the Extent of Myocardial Infarction at 6 Months: An OxAMI Study (Oxford Acute Myocardial Infarction)

ObjectivesThe aim of this study was to define which measure of microvascular best predicts the extent of left ventricular (LV) infarction.BackgroundMicrovascular injury after ST-segment elevation myocardial infarction (STEMI) is an important determinant of outcome. Several invasive measures of the microcirculation at primary percutaneous coronary intervention (PPCI) have been described. One such measure is zero-flow pressure (Pzf), the calculated pressure at which coronary flow would cease.MethodsIn 34 STEMI patients, Pzf, hyperemic microvascular resistance (hMR), and index of microcirculatory resistance (IMR) were derived using thermodilution flow/pressure and Doppler flow/pressure wire assessment of the infarct-related artery following PPCI. The extent of infarction was determined by blinded late gadolinium enhancement on cardiac magnetic resonance at 6 months post-PPCI. Infarction of ≥24% total LV mass was used as a categorical cutoff in receiver-operating characteristic curve analysis.ResultsPzf was superior to both hMR and IMR for predicting ≥24% infarction area under the curve: 0.94 for Pzf versus 0.74 for hMR (p = 0.04) and 0.54 for IMR (p = 0.003). Pzf ≥42 mm Hg was the optimal cutoff value, offering 100% sensitivity and 73% specificity. Patients with Pzf ≥42 mm Hg also had a lower salvage index (61.3 ± 8.1 vs. 44.4 ± 16.8, p = 0.006) and 6-month ejection fraction (62.4 ± 3.6 vs. 49.9 ± 9.6, p = 0.002). In addition, there were significant direct relationships between Pzf and troponin area under the curve (rho = 0.55, p = 0.002), final infarct mass (rho = 0.75, p < 0.0001), percentage of LV infarction and percent transmurality of infarction (rho = 0.77 and 0.74, respectively, p < 0.0001), and inverse relationships with myocardial salvage index (rho = −0.53, p = 0.01) and 6-month ejection fraction (rho = −0.73, p = 0.0001).ConclusionsPzf measured at the time of PPCI is a better predictor of the extent of myocardial infarction than hMR or IMR. Pzf may provide important prognostic information at the time of PPCI and merits further investigation in clinical studies with relevant outcome measures.     

A Prospective,Single-Arm,Multicenter Trial of Ultrasound-Facilitated,Catheter-Directed,Low-Dose Fibrinolysis for Acute Massive and Submassive Pulmonary Embolism: The SEATTLE II Study

ObjectivesThis study conducted a prospective, single-arm, multicenter trial to evaluate the safety and efficacy of ultrasound-facilitated, catheter-directed, low-dose fibrinolysis, using the EkoSonic Endovascular System (EKOS, Bothell, Washington).BackgroundSystemic fibrinolysis for acute pulmonary embolism (PE) reduces cardiovascular collapse but causes hemorrhagic stroke at a rate exceeding 2%.MethodsEligible patients had a proximal PE and a right ventricular (RV)-to-left ventricular (LV) diameter ratio ≥0.9 on chest computed tomography (CT). We included 150 patients with acute massive (n = 31) or submassive (n = 119) PE. We used 24 mg of tissue-plasminogen activator (t-PA) administered either as 1 mg/h for 24 h with a unilateral catheter or 1 mg/h/catheter for 12 h with bilateral catheters. The primary safety outcome was major bleeding within 72 h of procedure initiation. The primary efficacy outcome was the change in the chest CT–measured RV/LV diameter ratio within 48 h of procedure initiation.ResultsMean RV/LV diameter ratio decreased from baseline to 48 h post-procedure (1.55 vs. 1.13; mean difference, −0.42; p < 0.0001). Mean pulmonary artery systolic pressure (51.4 mm Hg vs. 36.9 mm Hg; p < 0.0001) and modified Miller Index score (22.5 vs. 15.8; p < 0.0001) also decreased post-procedure. One GUSTO (Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries)–defined severe bleed (groin hematoma with transient hypotension) and 16 GUSTO-defined moderate bleeding events occurred in 15 patients (10%). No patient experienced intracranial hemorrhage.ConclusionsUltrasound-facilitated, catheter-directed, low-dose fibrinolysis decreased RV dilation, reduced pulmonary hypertension, decreased anatomic thrombus burden, and minimized intracranial hemorrhage in patients with acute massive and submassive PE. (A Prospective, Single-arm, Multi-center Trial of EkoSonic® Endovascular System and Activase for Treatment of Acute Pulmonary Embolism (PE) [SEATTLE II]; NCT01513759)     

Surgical Sutureless and Transcatheter Aortic Valves: Hemodynamic Performance and Clinical Outcomes in Propensity Score-Matched High-Risk Populations With Severe Aortic Stenosis

ObjectivesIn propensity score–matched patients with severe aortic stenosis treated with surgical aortic valve replacement (AVR) with the 3f Enable sutureless prosthesis (Medtronic, Minneapolis, Minnesota) or transcatheter aortic valve replacement (TAVR), the hemodynamic performance of both valves and mid-term survival of patients were evaluated.BackgroundData on hemodynamic performance of surgical sutureless bioprostheses in high operative risk patients with aortic stenosis are scarce.MethodsOf 258 patients undergoing TAVR or surgical aortic valve replacement with the 3f Enable valve, 80 (79 ± 5 years of age, 100% men) were included in the current analysis on the basis of propensity score 1:1 matching for baseline clinical and hemodynamic characteristics. All patients had hemodynamic echocardiographic evaluation at baseline and discharge. Mid-term survival was analyzed.ResultsCompared with the 3f Enable valve, TAVR prostheses (Edwards SAPIEN XT [Edwards Lifesciences, Irvine, California] and CoreValve [Medtronic]) had larger effective orifice area index (1.00 ± 0.30 cm²/m² vs. 0.76 ± 0.22 cm²/m²; p < 0.001), lower pressure gradient (8.14 ± 4.21 mm Hg vs. 10.72 ± 4.01 mm Hg; p = 0.006), less frequent prosthesis-patient mismatch (30.0% vs. 67.5%; p = 0.001), and low flow (46.2% vs. 72.5%; p = 0.02), but more frequent aortic regurgitation (87.5% vs. 20.0%; p < 0.001). The presence of prosthesis-patient mismatch was independently associated with a low-flow state at discharge (odds ratio: 4.70; p = 0.004) and independently associated with the use of the sutureless prosthesis (odds ratio: 3.90; p = 0.02). However, the survival of the 2 groups was comparable after 1.5-year (interquartile range: 0.79 to 2.01 years) follow-up (log-rank test, p = 0.95).ConclusionsTAVR prostheses demonstrated better hemodynamics than the 3f Enable valve but a higher incidence of aortic regurgitation. However, these differences did not influence mid-term survival of patients.     

Echocardiographic Evaluation of Hemodynamics in Patients With Systolic Heart Failure Supported by a Continuous-Flow LVAD

BackgroundHemodynamics assessment is important for detecting and treating post-implant residual heart failure, but its accuracy is unverified in patients with continuous-flow left ventricular assist devices (CF-LVADs).ObjectivesWe determined whether Doppler and 2-dimensional transthoracic echocardiography reliably assess hemodynamics in patients supported with CF-LVADs.MethodsSimultaneous echocardiography and right heart catheterization were prospectively performed in 50 consecutive patients supported by using the HeartMate II CF-LVAD at baseline pump speeds. The first 40 patients were assessed to determine the accuracy of Doppler and 2-dimensional echocardiography parameters to estimate hemodynamics and to derive a diagnostic algorithm for discrimination between mean pulmonary capillary wedge pressure ≤15 versus >15 mm Hg. Ten patients served as a validation cohort.ResultsDoppler echocardiographic and invasive measures of mean right atrial pressure (RAP) (r = 0.863; p < 0.0001), systolic pulmonary artery pressure (sPAP) (r = 0.880; p < 0.0001), right ventricular outflow tract stroke volume (r = 0.660; p < 0.0001), and pulmonary vascular resistance (r = 0.643; p = 0.001) correlated significantly. Several parameters, including mitral ratio of the early to late ventricular filling velocities >2, RAP >10 mm Hg, sPAP >40 mm Hg, left atrial volume index >33 ml/m², ratio of mitral inflow early diastolic filling peak velocity to early diastolic mitral annular velocity >14, and pulmonary vascular resistance >2.5 Wood units, accurately identified patients with pulmonary capillary wedge pressure >15 mm Hg (area under the curve: 0.73 to 0.98). An algorithm integrating mitral inflow velocities, RAP, sPAP, and left atrial volume index was 90% accurate in distinguishing normal from elevated left ventricular filling pressures.ConclusionsDoppler echocardiography accurately estimated intracardiac hemodynamics in these patients supported with CF-LVAD. Our algorithm reliably distinguished normal from elevated left ventricular filling pressures.     

Heart rate variability parameters and ventricular arrhythmia correlate with pulmonary arterial pressure in adult patients with idiopathic pulmonary arterial hypertension

ObjectiveThis aim of this study was to correlate heart rate variability (HRV) parameters to pulmonary arterial pressure (PAP) in patients with purely idiopathic pulmonary arterial hypertension (IPAH).BackgroundHRV is decreased in patients with PAH. Whether HRV indices can be used to assess PAP in IPAH patients remains unclear.MethodsHRV parameters obtained by 24-h ECG were evaluated in 26 IPAH patients and 51 controls.ResultsTime-domain HRV parameters (SDNN, p < 0.0001; SDANN, p < 0.0001; RMSSD, p = 0.006) were lower in IPAH patients. Frequency-domain indices (high-frequency power, HFP, p = 0.001; low-frequency power, LFP, p = 0.003; total power, TP, p = 0.001) were also decreased in IPAH patients. In IPAH patients, RMSSD (p = 0.001), HFP (p = 0.015), and LFP (p = 0.027) were significantly correlated with PAP. IPAH patients had longer QTc intervals (p < 0.0001) and more premature ventricular contractions (p < 0.0001) than controls.ConclusionsIPAH is associated with autonomic dysfunction. RMSSD, HFP, and LFP may be used as a supplemental tool to assess PAP in IPAH patients. IPAH patients with autonomic dysfunction are at high risk for ventricular arrhythmia.     

Thrombocytopenia is an independent predictor of mortality in pulmonary hypertension

BackgroundEstablished prognostic factors for pulmonary hypertension (PH) include brain natriuretic peptide, troponins and hemodynamic measures such as central venous pressure and cardiac output. The prognostic role of thrombocytopenia, however, has yet to be determined in patients with PH. The aim of this study was to evaluate effect of thrombocytopenia on mortality in patients with PH.Methods521 patients with severe PH, defined by a pulmonary artery systolic pressure >60 mm Hg on transthoracic echocardiography and a platelet count measured within one month after diagnosis were enrolled from three hospitals of Montefiore Medical Center. The cohort was divided into two groups: mild thrombocytopenia to a normal platelet count (platelet count 100,000–450,000 per uL); and moderate to severe thrombocytopenia (platelet count <100,000 per uL). Inpatient and social security death records were used to determine 1-year all-cause mortality.ResultsMean age was 70.3 ± 15.6 with 40% of patients being male. Overall mortality at 1 year was 30.7%, with increased mortality in PH patients with mild thrombocytopenia compared to those with moderate to severe thrombocytopenia (46.5% vs. 27.0%, p < 0.001). In multivariate analysis, moderate to severe thrombocytopenia remained an independent predictor of mortality (HR 1.798, 95% CI 1.240–2.607, p = 0.002).ConclusionsModerate to severe thrombocytopenia is an independent predictor of higher mortality in patients with severe PH. These findings may support the use of thrombocytopenia as a useful prognostic indicator in patients with severe PH.     

Clinical Outcome of Isolated Tricuspid Regurgitation

ObjectivesThe aim of this study was to assess the outcome of isolated tricuspid regurgitation (TR) and the added value of quantitative evaluation of its severity.BackgroundTR is of uncertain clinical outcome due to confounding comorbidities. Isolated TR (without significant comorbidities, structural valve disease, significant pulmonary artery systolic pressure elevation by Doppler, or overt cardiac cause) is of unknown clinical outcome.MethodsIn patients with isolated TR assessed both qualitatively and quantitatively by a proximal isovelocity surface area method, a long-term outcome analysis was conducted. Patients with severe comorbid diseases were excluded.ResultsThe study involved 353 patients with isolated TR (age 70 years; 33% male; ejection fraction, 63%; all with right ventricular systolic pressure <50 mm Hg). Severe isolated TR was diagnosed in 76 patients (21.5%) qualitatively and 68 patients (19.3%) by quantitative criteria (effective regurgitant orifice [ERO] ≥40 mm²). The 10-year survival and cardiac event rates were 63 ± 5% and 29 ± 5%. Severe isolated TR independently predicted higher mortality (adjusted hazard ratio: 1.78 [95% confidence interval (CI): 1.10 to 2.82], p = 0.02 for qualitative definition and 2.67 [95% CI: 1.66 to 4.23] for an ERO ≥40 mm², p < 0.0001). The addition of grading by quantitative criteria in nested models eliminated the significance of the qualitative grading and improved the model prediction (p < 0.001 for survival and p = 0.02 for cardiac events). The 10-year survival rate was lower with an ERO ≥40 mm² versus <40 mm² (38 ± 7% vs. 70 ± 6%; p < 0.0001), independent of all characteristics, right ventricular size or function, comorbidity, or pulmonary pressure (p < 0.0001 for all), and lower than expected in the general population (p < 0.001). Freedom from cardiac events was lower with an ERO ≥40 mm² versus <40 mm² independently of all characteristics, right ventricular size or function, comorbidity, or pulmonary pressure (p < 0.0001 for all). Cardiac surgery for severe isolated TR was rarely performed (16 ± 5% 5 years after diagnosis).ConclusionsIsolated TR can be severe and is associated with excess mortality and morbidity, warranting heightened attention to diagnosis and quantitation. Quantitative assessment of TR, particularly ERO measurement, is a powerful independent predictor of outcome, superior to standard qualitative assessment.     

5-Year Outcomes After Transcatheter Aortic Valve Implantation With CoreValve Prosthesis

ObjectivesThe purpose of this analysis was to assess 5-year outcomes of transcatheter aortic valve implantation (TAVI) using the current technology of the self-expanding CoreValve prosthesis (Medtronic Inc., Minneapolis, Minnesota).BackgroundThere is a paucity of evidence on long-term durability of currently available transcatheter heart valves.MethodsStarting in June 2007, all consecutive patients with severe aortic stenosis undergoing TAVI with the third-generation 18-F CoreValve device in 8 Italian centers were prospectively included in the ClinicalService Project. For the purposes of this study, we included only consecutive patients with 5-year follow-up data available (n = 353) treated from June 2007 to August 2009. All outcomes were reported according to VARC (Valve Academic Research Consortium)-1 criteria.ResultsAll-cause mortality rates at 1, 2, 3, 4, and 5 years were 21%, 29%, 38%, 48%, and 55.0%, respectively. Cardiovascular mortality rates at 1, 2, 3, 4, and 5 years were 10%, 14%, 19%, 23%, and 28.0%, respectively. The overall neurological event rate at 5 years was 7.5%, of which more than two-thirds occurred early after the procedure. During follow-up, there were 241 rehospitalizations for cardiovascular reasons in 164 (46%) patients. Among all rehospitalizations, acute heart failure was the most frequently reported (42.7%), followed by requirement of permanent pacemaker implantation (17.4%). On echocardiography, mean transaortic gradients decreased from 55.6 ± 16.8 mm Hg (pre-TAVI) to 12.8 ± 10.9 mm Hg (5-year post-TAVI) (p < 0.001). Late prosthesis failure occurred in 5 cases (1.4%); among these, redo TAVI was successfully carried out in 2 patients (0.6%) presenting with symptomatic prosthesis restenosis. The remaining 3 cases of prosthesis failure did not undergo further invasive interventions. Ten patients (2.8%) showed late mild stenosis with a mean transaortic gradient ranging from 20 to 40 mm Hg. No other cases of structural or nonstructural valvular deterioration were observed. Valve thrombosis or late valve embolization were not reported.ConclusionsTAVI with the currently adopted CoreValve generation was associated with sustained clinical outcomes up to 5-year follow-up, with a low rate (1.4%) of significant prosthetic valve degeneration. The procedure appears to be an adequate and lasting resolution of aortic stenosis in selected high-risk patients.     

Atrial septostomy decreases sympathetic overactivity in pulmonary arterial hypertension

BACKGROUND: We have reported previously that the sympathetic nervous system is activated in patients with pulmonary arterial hypertension (PAH), and that this is only partly explained by a decrease in arterial oxygenation. Possible causes for increased muscle sympathetic nerve activity (MSNA) in patients with PAH include right atrial distension and decreased cardiac output. Both may be improved by atrial septostomy, but this intervention also further decreases arterial oxygenation. In the present study, we wanted to investigate the effect of atrial septostomy on MSNA in patients with PAH. METHODS: We recorded BP, heart rate (HR), arterial O2 saturation (SaO2), and MSNA before and after atrial septostomy in PAH patients (mean [+/- SE] age, 48 +/- 5 years) and in closely matched control subjects. Measurements were also performed after septostomy, while SaO2 was brought to the preprocedure level by supplemental O2 therapy. RESULTS: Compared to the control subjects (n = 10), the PAH patients (n = 11) had a lower mean BP (75 +/- 2 vs 96 +/- 3 mm Hg, respectively; p < 0.001), lower mean SaO2 (92 +/- 1% vs 97 +/- 0%, respectively; p < 0.001), increased mean HR (84 +/- 4 vs 68 +/- 3 beats/min; p < 0.01), and markedly increased mean MSNA (76 +/- 5 vs 29 +/- 2 bursts per minute; p < 0.001). Atrial septostomy decreased mean SaO2 (to 85 +/- 2%; p < 0.001) and mean MSNA (to 69 +/- 4 bursts per minute; p < 0.01), but did not affect HR or BP. Therapy with supplemental O2 did not affect MSNA, BP, or HR. The decrease in MSNA was correlated to the decrease in right atrial pressure (r = 0.62; p < 0.05). CONCLUSIONS: Atrial septostomy in PAH patients decreases sympathetic hyperactivity despite an associated decrease in arterial oxygenation, and this appears to be related to decreased right atrial distension.     

One-Year Follow-Up of the Melody Transcatheter Pulmonary Valve Multicenter Post-Approval Study

ObjectivesThis study sought to confirm that the short-term hemodynamic effectiveness of the Melody transcatheter pulmonary valve (TPV) (Medtronic, Inc., Minneapolis, Minnesota) achieved by real-world providers is equivalent to the historical results established in the initial 5-center Investigational Device Exemption trial.BackgroundTPV replacement has been used to treat right ventricular outflow tract (RVOT) conduit dysfunction for >10 years. The Melody TPV received U.S. Food and Drug Administration approval in 2010 as a Humanitarian Use Device.MethodsPatients with dysfunctional RVOT conduits were entered in this prospective, nonrandomized study at 10 centers. The primary endpoint was acceptable hemodynamic function at 6 months post-implantation, defined as a composite of RVOT echocardiographic mean gradient ≤30 mm Hg, pulmonary regurgitation less than moderate as measured by echocardiography, and freedom from conduit reintervention and reoperation.ResultsCardiac catheterization was performed in 120 patients for potential implantation of the Melody TPV; of these, 100 patients were implanted, with a 98.0% procedural success rate. There were no procedure-related deaths. Acceptable hemodynamic function at 6 months was achieved in 96.7% of patients with evaluable data (87.9% of the entire implanted cohort), with results maintained through 1 year. No patient had moderate or severe pulmonary regurgitation after implantation. No patient required catheter reintervention in the first year after implantation, and 2 patients required reoperation for conduit replacement. The rate of freedom from TPV dysfunction was 96.9% at 1 year.ConclusionsThis first prospective, real-world experience with the Melody TPV in the United States demonstrates continued high procedural success, excellent short-term TPV function, and low reintervention and reoperation rates at 1 year. (Melody Transcatheter Pulmonary Valve Post-Approval Study; NCT01186692)     

Atrial Remodeling Following Catheter-Based Renal Denervation Occurs in a Blood Pressure– and Heart Rate–Independent Manner

ObjectivesThis study sought to investigate left atrial (LA) remodeling in relation to blood pressure (BP) and heart rate (HR) after renal sympathetic denervation (RDN).BackgroundIn addition to reducing BP and HR in certain patients with hypertension, RDN can decrease left ventricular (LV) mass and ameliorate LV diastolic dysfunction.MethodsBefore and 6 months after RDN, BP, HR, LV mass, left atrial volume index (LAVI), diastolic function (echocardiography), and premature atrial contractions (PAC) (Holter electrocardiogram) were assessed in 66 patients with resistant hypertension.ResultsRDN reduced office BP by 21.6 ± 3.0/10.1 ± 2.0 mm Hg (p < 0.001), and HR by 8.0 ± 1.3 beats/min (p < 0.001). At baseline, LA size correlated with LV mass, diastolic function, and pro-brain natriuretic peptide, but not with BP or HR. Six months after RDN, LAVI was reduced by 4.0 ± 0.7 ml/kg/m² (p < 0.001). LA size decrease was stronger when LAVI at baseline was higher. In contrast, the decrease in LAVI was not dependent on LV mass or diastolic function (E/E′ or E/A) at baseline. Furthermore, LAVI decreased without relation to decrease in systolic BP or HR. Additionally, occurrence of PAC (median of >153 PAC/24 h) was reduced (to 68 PAC/24 h) by RDN, independently of changes in LA size.ConclusionsIn patients with resistant hypertension, LA volume and occurrence of PAC decreased 6 months after RDN. This decrease was independent of BP and HR at baseline or the reduction in BP and HR reached by renal denervation. These data suggest that there is a direct, partly BP-independent effect of RDN on cardiac remodeling and occurrence of premature atrial contractions.     

Acute Kidney Injury in Patients With Chronic Kidney Disease Undergoing Internal Carotid Artery Stent Implantation

ObjectivesThis study sought to investigate acute kidney injury (AKI) following carotid artery stenting (CAS).BackgroundFew data exist on AKI following CAS.MethodsThis study evaluated 126 chronic kidney disease (CKD) patients who underwent CAS. The risk for contrast-induced AKI was defined by the Mehran score. Hemodynamic depression (i.e., periprocedural systolic blood pressure <90 mm Hg or heart rate <60 beats/min), AKI (i.e., an increase of ≥0.3 mg/dl in the serum creatinine concentration at 48 h), and 30-day major adverse events (including death, stroke, and acute myocardial infarction) were assessed.ResultsAKI occurred in 26 patients (21%). Although baseline kidney function and contrast volume were similar in the AKI group and the non-AKI group, the risk score was higher (10 ± 3 vs. 8 ± 3; p = 0.032), and hemodynamic depression (mostly due to hypotension) (65.5% vs. 35%; p = 0.005) was more common in the AKI group. The threshold of hemodynamic depression duration for AKI development was 2.5 min (sensitivity 54%, specificity 82%). Independent predictors of AKI were hemodynamic depression (odds ratio [OR]: 4.01; 95% confidence interval [CI]: 1.07 to 15.03; p = 0.009), risk score (OR: 1.29; 95% CI: 1.03 to 1.60; p = 0.024), and male sex (OR: 6.07; 95% CI: 1.18 to 31.08; p = 0.021). Independent predictors of 30-day major adverse events that occurred more often in the AKI group (19.5% vs. 7%; p = 0.058) were AKI (HR: 4.83; 95% CI: 1.10 to 21.24; p = 0.037) and hemodynamic depression (HR: 5.58; 95% CI: 1.10 to 28.31; p = 0.038).ConclusionsAKI in CKD patients undergoing CAS is mostly due to hemodynamic depression and is associated with a higher 30-day major adverse events rate.     

Real-Time Ultrasound Guidance Facilitates Transradial Access: RAUST (Radial Artery Access With Ultrasound Trial)

ObjectivesThis study sought to assess the utility of ultrasound (US) guidance for transradial arterial access.BackgroundUS guidance has been demonstrated to facilitate vascular access, but has not been tested in a multicenter randomized fashion for transradial cardiac catheterization.MethodsWe conducted a prospective multicenter randomized controlled trial of 698 patients undergoing transradial cardiac catheterization. Patients were randomized to needle insertion with either palpation or real-time US guidance (351 palpation, 347 US). Primary endpoints were the number of forward attempts required for access, first-pass success rate, and time to access.ResultsThe number of attempts was reduced with US guidance [mean: 1.65 ± 1.2 vs. 3.05 ± 3.4, p < 0.0001; median: 1 (interquartile range [IQR]: 1 to 2) vs. 2 (1 to 3), p < 0.0001] and the first-pass success rate improved (64.8% vs. 43.9%, p < 0.0001). The time to access was reduced (88 ± 78 s vs. 108 ± 112 s, p = 0.006; median: 64 [IQR: 45 to 94] s vs. 74 [IQR: 49 to 120] s, p = 0.01). Ten patients in the control group required crossover to US guidance after 5 min of failed palpation attempts with 8 of 10 (80%) having successful sheath insertion with US. The number of difficult access procedures was decreased with US guidance (2.4% vs. 18.6% for ≥5 attempts, p < 0.001; 3.7% vs. 6.8% for ≥5min, p = 0.07). No significant differences were observed in the rate of operator-reported spasm, patient pain scores following the procedure, or bleeding complications.ConclusionsUltrasound guidance improves the success and efficiency of radial artery cannulation in patients presenting for transradial catheterization. (Radial Artery Access With Ultrasound Trial [RAUST]; NCT01605292)     

Relationship between QRS characteristics and delayed-enhancement cardiac magnetic resonance in patients with ischemic cardiomyopathy

BackgroundWe explored the relationship between QRS characteristics and myocardial phenotype by delayed-enhancement cardiac magnetic resonance (DE-CMR) in patients with coronary heart disease (CHD).Methods and resultsEighty five consecutive patients with CHD that were referred for DE-CMR evaluation constituted the study population. Of a total of 1445 left ventricular (LV) segments evaluated, 346 (23.9%) segments had fibrosis.Compared to patients without pathological Q waves, patients with pathological Q waves showed a higher number of segments with fibrosis (5.9 ± 3.1 vs. 2.7 ± 2.8, p < 0.001), and lower left ventricular ejection fraction (LVEF) (42.9 ± 13.6% vs. 51.8 ± 18.3, p = 0.01); whereas no significant differences were observed regarding LV size.When discriminated in according to the QRS duration tertiles, no significant differences were observed regarding the number of segments with fibrosis (p = 0.34), whereas the highest QRS tertile was related to the presence of a low LVEF (p = 0.005) and larger LV size (p = 0.01). QRS fragmentation (fQRS), defined as the presence of an R′ or notching in the nadir of the R wave or the S wave, or the presence of >1 R′ in 2 contiguous leads, was significantly related to LV size (LV end diastolic volume 153.6 ± 81.6 ml, vs. 111.5 ± 41.4 ml, p = 0.003), function (LVEF 43.2 ± 15.9% vs. 53.6 ± 16.3%, p = 0.005), and extent of fibrosis (5.1 ± 3.4 segments vs. 3.2 ± 3.1 segments, p = 0.01).ConclusionsIn the present study, fQRS was the only QRS-derived variable systematically and more closely related to LV size, LV systolic function, and to the presence and extent of fibrosis.