Does residual aortic regurgitation after transcatheter aortic valve implantation increase mortality in all patients? The importance of baseline natriuretic peptides.

BACKGROUND: Aortic regurgitation (AR) is an important complication of transcatheter aortic valve implantation (TAVI) and even moderate AR is associated with increased mortality after TAVI. The association with decreased survival is unclear. We aimed to analyse the impact of AR after TAVI as a function of baseline NT-proBNP. METHODS: We included 236 consecutive patients implanted in our centre with the SAPIEN and SAPIEN XT valves, via the transfemoral route. AR was evaluated by transthoracic echocardiography. NT-proBNP was measured 24h before implantation and patients were divided according to the median value. RESULTS: Median age was 85 years (80-89) and 137 (58.1%) were women. Patients with high NT-proBNP had lower left ventricular ejection fraction: 52% (35-65) vs. 63% (55-70), p<0.001, larger telediastolic diameters: 56 mm (49-61) vs. 52 mm (46-56), p=0.01, and more severe aortic stenosis: 0.62 ± 0.15 cm(2) vs. 0.70 ± 0.2 cm(2), p<0.001. Pre-procedural moderate or severe AR (42% vs. 26%, p=0.013) and mitral regurgitation (56% vs. 36%, p=0.004) were more common in the high NT-proBNP group. After TAVI, moderate or severe AR occurred in 26% of patients and was associated with increased 2-year mortality only in the low NT-proBNP group, while patients in the high NT-proBNP group were not affected. CONCLUSIONS: Moderate or severe AR after TAVI was not associated with increased 2-year mortality in patients with high baseline NT-proBNP. Our data suggest that the impact of AR after TAVI is absent in patients with significant pre-procedural AR or mitral regurgitation and more severe aortic stenosis.

Expandable sheath for transfemoral transcatheter aortic valve replacement: procedural outcomes and complications.

AIMS: It is currently unknown whether the expandable sheath (e-sheath) for transfemoral Edwards transcatheter aortic valve replacement (TAVR) has a lower rate of access complications than the 18/19F fixed size sheath (f-sheath). Our aim was to compare the incidence of procedural complications when using f-sheath vs. e-sheath during TAVR. METHODS: We included 162 consecutive patients, implanted with the Edwards SAPIEN XT valve in our center. Access closure was obtained with the Prostar system in all cases. E-sheath was used in 80 patients (49%). RESULTS: Minimal ilio-femoral diameter was comparable in e-sheath and f-sheath groups: 6.7 (6.1-7.7) vs. 7 (6.2-8) mm, P = 0.25, as was the frequency of peripheral artery disease: 12.5% vs. 13.4%, P = 1.0. VARC major vascular complications rate was similar in the 2 groups: e-sheath 7 (8.8%) vs. f-sheath 6 (7.3%), P = 0.74, as was the incidence of minor vascular complications: 8 (10%) vs. 14 (17.1%), P = 0.19, life-threatening bleeding: 6 (7.5%) vs. 6 (7.3%), P = 0.96, major and minor bleeding and use of covered vascular stents: 9 (11%) vs. 6 (7.5%), P = 0.59. CONCLUSIONS: The e-sheath for TAVR with the Edwards valve did not show an advantage over the f-sheath in reducing vascular and bleeding complications.

Safety and efficacy of everolimus-eluting stents versus paclitaxel-eluting stents in a diabetic population.

OBJECTIVES: This study aimed to analyze the use of everolimus-eluting stents (EES) and paclitaxel-eluting stents (PES) in an unrestricted diabetic population and to compare the performance of these two drug-eluting stents. BACKGROUND: EES have demonstrated superiority in efficacy when compared to PES in a general population. However, it is controversial whether this superiority holds true in a diabetic population. METHODS: From March 2004 to May 2010, 968 patients with consecutive diabetes who underwent percutaneous coronary intervention and implantation of an EES (n = 388) or PES (n = 580) at our institution. In-hospital, 1-month, 6-month, and 1-year clinical outcomes were analyzed and compared. Correlates of major adverse cardiac events (MACE) were identified. RESULTS: Baseline clinical characteristics were similar between stent types except for more family history of coronary artery disease in the PES group and more insulin-dependent diabetes and unstable angina at initial diagnosis in the EES group. The PES group had higher number of lesions treated, longer stents used, and a higher proportion of intravascular ultrasound and glycoprotein IIb/IIIa inhibitor use. The EES group had more type C and distal lesions. There was higher target lesion revascularization (TLR)-MACE in the PES group (3.3% vs. 1.0%, P = 0.03) as well as a higher rate of stent thrombosis (ST) (8 patients vs. 0 in the EES group, P = 0.03). ST continued to be higher in the PES group at 6 and 12 months and mortality was higher at 12 months in the PES group (9.4% vs. 5.2%, P = 0.02). After adjustment, no significant differences were found between stent types on Cox regression analysis for hazard ratios at 1-year follow-up of TLR-MACE. CONCLUSIONS: In a diabetic population undergoing PCI, the use of an EES compared to PES was associated with lower rates of stent thrombosis; but after adjustment the composite TLR-MACE at 1 year was similar between both stents.

The impact of intra-aortic balloon counter-pulsation on in-hospital mortality in patients presenting with anterior ST-elevation myocardial infarction without cardiogenic shock.

OBJECTIVES: This study aimed to determine whether the elective insertion of an intra-aortic balloon counter pulsation (IABP) device at the time of myocardial revascularization in patients presenting with an acute anterior ST-elevation myocardial infarction (STEMI) without cardiogenic shock has any impact on the in-hospital rate of cardiac mortality. BACKGROUND: The role of IABP in patients presenting with an acute MI without cardiogenic shock remains ill defined. METHODS: The present study comprised 605 consecutive patients who underwent primary percutaneous coronary intervention for an anterior STEMI without cardiogenic shock. Patients who received IABP at the time of their coronary revascularization (n=105) were compared to those who had not (n=500). Patients with stable angina, unstable angina, non-STEMI, non-anterior STEMI, and cardiogenic shock were excluded. RESULTS: The two cohorts were well matched for the conventional risk factors for coronary artery disease. Although the left ventricular ejection fraction was significantly lower in the patients who received IABP (0.32±0.11 vs. 0.39±0.12; P<0.001), the two cohorts were well matched for history of MI, coronary revascularization, and chronic renal impairment. Following propensity scoring, the in-hospital rate of cardiac death was similar between the two cohorts (5.6% vs. 0%; P=.12) as was the rate of vascular complications. Major bleeding was significantly greater in the IABP cohort (10.0% vs. 0%; P=.01) leading to a greater transfusion requirement (14.9% vs. 2.9%; P=.01). CONCLUSION: The adjunctive use of an IABP in patients presenting with an acute anterior STEMI without cardiogenic shock may not be associated with an in-hospital mortality benefit.

Frequency of conduction disturbances after Edwards SAPIEN percutaneous valve implantation.

Disturbances in atrioventricular conduction and the additional need for a permanent pacemaker are recognized complications after transcatheter aortic valve replacement (TAVR). We analyzed the incidence of postprocedural conduction disorders and the need for permanent pacemaker implantation in patients undergoing TAVR with the Edwards SAPIEN valve. In 125 consecutive patients with symptomatic, severe aortic stenosis undergoing TAVR, a standard 12-lead electrocardiogram was obtained before and serially after the procedure. The cohort was divided into 2 groups with regard to the post-TAVR appearance of conduction disturbances, defined as left bundle branch block, right bundle branch block, fascicular hemiblock, atrioventricular block, and the need for a permanent pacemaker. The patients with and without conduction disturbances were compared. After TAVR, 19 patients (15.2%) met the study definition of a "new conduction defect" and 5 patients (4%) required a permanent pacemaker because of an advanced atrioventricular block. New left bundle branch block appeared in 5 patients (4%) and left anterior hemiblock in 9 (7.2%). No new right bundle branch block or left posterior hemiblock was observed. Although most baseline, echocardiographic, and procedural characteristics were equally distributed, the patients with new conduction disturbances more often had diabetes mellitus and peripheral vascular disease. Also, they more often were taking an angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker, and the procedure was performed more often with apical access (12 [63.2%] vs 7 with femoral access [36.8%], p = 0.002). In conclusion, although the incidence of conduction disturbances was high after TAVR using the Edwards SAPIEN valve, with a significant increase in the rate of left bundle branch block and left anterior hemiblock, the need for permanent pacemaker implantation after TAVR with this valve remained low.

Transcatheter aortic valve replacement under monitored anesthesia care versus general anesthesia with intubation.

AIMS: Most transcatheter aortic valve replacement (T-AVR) using the Edwards SAPIEN transcatheter heart valve (Edwards Lifesciences, Irvine, CA) is done under general anesthesia. The present study aimed to examine the feasibility and safety of T-AVR under monitored anesthesia care and aimed to compare the clinical outcome to the outcome of patients who underwent general anesthesia. METHODS: The analysis included 92 consecutive patients undergoing T-AVR via the transfemoral approach guided by transesophageal echocardiography using the Edwards SAPIEN valve. The cohort was divided into two groups: I, monitored anesthesia care (n=70; 76.1%) and II, intubation (n=22; 23.9%). Monitored anesthesia care was given by anesthesiologists in one of two protocol regimens: Ketamine & Propofol or Dexmedetomidine. The crossover rate to general anesthesia and the clinical outcome of these two groups were compared. RESULTS: Baseline clinical characteristics of the two groups were similar, except for higher logistic EuroSCORE and prior stroke in the monitored anesthesia care group. Surgical access of the femoral artery was performed in 15 (68.1%) from the general anesthesia group and in 24 (34.2%) from the monitored anesthesia care group, p=0.05. The median procedure duration was significantly lower in the monitored anesthesia care group (91 vs. 155 min, p=0.008) and there was a trend to lower median intensive care unit stay and hospital stay (27 vs. 72 h, p=0.07 and 5 vs. 7.5 days, p=0.06, respectively). Of the patients with monitored anesthesia care, 8 (11.4%) converted to general anesthesia. CONCLUSION: T-AVR using the Edwards SAPIEN valve can be performed in the majority of cases with controlled monitored anesthesia care, thereby avoiding the necessity of general anesthesia and resulting in shorter procedure time and in-hospital length of stay.

Transapical aortic valve implantation in Rouen: four years' experience with the Edwards transcatheter prosthesis.

BACKGROUND: The first French transapical transcatheter aortic valve implantation (TAVI) was performed in July 2007 in our department. AIMS: To report 4-year outcomes of transapical implantation with the Edwards transcatheter bioprosthesis. METHODS: We prospectively evaluated consecutive patients who underwent transapical implantation with an Edwards transcatheter bioprosthesis between July 2007 and October 2011. Patients were not suitable for conventional surgery (due to severe comorbidities) or transfemoral implantation (due to poor femoral access). RESULTS: Among 61 patients (59.0% men), mean logistic EuroSCORE was 27.5 ± 14.9% and mean age was 81.0 ± 6.8 years. Successful valve implantation was achieved in 59/61 patients (96.7%) of patients. The other two patients required conversion to conventional surgery due to prosthesis embolization and died. Six additional patients died in the postoperative period. Causes of perioperative death were two septic shocks (one of peritonitis), two multi-organ failure, one ventricular fibrillation and one respiratory insufficiency. Intraprocedural stroke was not observed in any patient. The actuarial survival rates at 1, 2 and 4 years were 73.8%, 67.2% and 41.0%. During this 4-year period, four patients died of cardiovascular events, but no impairment of transprosthesis gradient was observed. CONCLUSION: Our series of 61 patients who underwent transapical implantation of the Edwards transcatheter bioprosthesis shows satisfactory results, similar to other reports, considering the high level of severity of patients referred for this method. Transapical access is a reliable alternative method for patients that cannot benefit from a transfemoral approach.

Comparison of outcome of higher versus lower transvalvular gradients in patients with severe aortic stenosis and low (<40%) left ventricular ejection fraction.

Left ventricular systolic dysfunction in patients with severe aortic stenosis (AS) is associated with poor outcome. This analysis was designed primarily to describe the clinical course of a large series of consecutive patients with severe AS and low ejection fraction (EF) (<40%) who, because of high surgical risk, were referred for transcatheter aortic valve implantation consideration. A cohort of 270 patients with severe AS and low EF (<40%) who were referred to participate in a clinical trial of transcatheter aortic valve implantation was studied. Clinical, hemodynamic, and periprocedural complications and follow-up mortality data were collected and compared between patients with low mean transvalvular gradients (≤40 mm Hg, n = 170 [63%]) and high transvalvular gradients (>40 mm Hg, n = 100 [37%]). Patients with low gradients were younger (mean age 79.8 ± 9.1 vs 83.8 ± 7.7 years, p <0.001) and had higher incidences of coronary artery disease and renal failure. Mean aortic valve area was larger (0.73 ± 0.23 vs 0.53 ± 0.18 cm(2), p <0.001), while mean EF (26.4 ± 6.9% vs 30.5% ± 6.6%, p <0.001), cardiac output (3.7 ± 1.1 vs 4.1 ± 1.3 L/min, p = 0.04), and cardiac index (1.9 ± 0.5 vs 2.1 ± 0.6 L/min/m(2), p = 0.04) were lower in patients with lower gradients compared to those with higher gradients, respectively. Mortality was higher in patients with low gradients (53.8%) at a mean follow-up of 151 days compared to those with high gradients (41%) at a mean follow-up of 256 days (p = 0.01). In conclusion, patients with severe AS and low EF with low transvalvular gradients are at higher risk for worse outcomes compared to patients with high transvalvular gradients. Surgery or transcatheter aortic valve implantation treatment and high baseline transvalvular gradient are associated with EF improvement.

Clinical and silent stroke following aortic valve surgery and transcatheter aortic valve implantation.

Transcatheter aortic valve implantation (TAVI) has been introduced as an alternative to conventional surgery for high-risk patients with aortic stenosis. A recently published randomized clinical trial demonstrated reduction of mortality in high-risk or inoperable patients when compared to medical treatment or balloon aortic valvuloplasty. Despite this evidence of superiority, the rate of TAVI complications is high, and perhaps the most devastating of the nonfatal complications is cerebral injury. This review will compare the incidence of stroke and "silent" cerebral injury after surgical aortic valve replacement and after TAVI and will discuss mechanisms that can lead to cerebral injury during these procedures and subsequently how to prevent this with new protection devices.

Outcome of percutaneous coronary intervention utilizing drug-eluting stents in patients with reduced left ventricular ejection fraction.

Ischemic cardiomyopathy with depressed left ventricular ejection fraction (LVEF) is predictive of death after percutaneous coronary intervention (PCI), but its association with stent thrombosis (ST) and the need for repeat revascularization is less clearly defined. In total 5,377 patients undergoing PCI were retrospectively evaluated. Multivariable Cox proportional hazards regression and competitive outcome analysis were employed. The primary end point was 1-year major adverse cardiac events (all-cause death, Q-wave myocardial infarction, ST, and target lesion revascularization [TLR]). Individual end points of ST and of TLR were also evaluated. Patients with normal LVEF (>50%) were compared to those with mild (41% to 50%), moderate (25% to 40%), and severe (<25%) decreases in LVEF. Patients with abnormal LVEF were older and more commonly diabetic and had renal insufficiency and heart failure syndrome (p <0.001 for all variables). These patients demonstrated more angiographically complex lesions and less frequently received a drug-eluting stent. The primary end point was significantly increased in patients with lower LVEF (9.7% for normal LVEF vs 20.6% for severely decreased LVEF, p <0.001). ST occurred more frequently in these patients (1.4% for normal LVEF vs 6% for severely decreased LVEF, p <0.001), but clinically driven TLR did not significantly change across LVEF categories. After adjustment, only moderate and severe LVEF decreases (i.e., LVEF ≤40%) demonstrated an association with major adverse cardiac events and with the individual outcome of ST. Subgroup analysis of patients receiving only a drug-eluting stent or a bare-metal stent demonstrated no statistically significant differences for the probability of ST. In conclusion, decreased LVEF is not associated with clinically driven TLR but does increase the risk of ST. Patients with LVEF ≤40% appear to be at significantly higher risk for ST and therefore might benefit from interventional and pharmacologic strategies aimed at minimizing this risk.

Frequency of cardiac conduction disturbances after balloon aortic valvuloplasty.

Disturbances in atrioventricular conduction are well-recognized complications of transcatheter aortic valve replacement. Percutaneous balloon aortic valvuloplasty (BAV) is a requisite step in transcatheter aortic valve replacement; however, the contribution of the BAV to atrioventricular conduction disturbances has not been elucidated. The present analysis was undertaken to ascertain the incidence and type of electrocardiographic changes associated with BAV and to consider the role of BAV in the conduction abnormalities after transcatheter aortic valve replacement. In 271 consecutive patients with symptomatic, severe aortic stenosis undergoing BAV, a standard 12-lead electrocardiogram was obtained before and serially after the procedure. Each was examined by experienced electrocardiographers. The cohort was divided into 2 groups with regard to the post-BAV appearance of conduction disturbances. The clinical and procedural characteristics of patients with these disturbances were compared to those in whom no conduction disturbance appeared. After BAV, 23 patients (8.5%) met the study definition of "new conduction defect": 4 patients (1.5%) required permanent pacemaker implantation for advanced atrioventricular block. New left bundle branch block appeared in 9 (3.3%) and left anterior hemiblock in 7 (2.6%). New right bundle branch block appeared in 2 and left posterior hemiblock in 1. No significant difference was found in the clinical or procedural characteristics. The ratio of the balloon size to the left ventricular outflow tract diameter was 1.21 ± 1.6 in those with new conduction defects and 1.15 ± 0.12 (p = 0.032) in those without. In conclusion, BAV is associated with a low incidence of cardiac conduction disturbances and a requirement for permanent ventricular pacing. The size of the valvuloplasty balloon should be carefully selected to avoid oversizing, which can lead to the development of postprocedure conduction disturbances.

Outcomes of coronary arterial perforations during percutaneous coronary intervention with bivalirudin anticoagulation.

Coronary perforation (CP) is a rare but catastrophic event that may be influenced by the procedural anticoagulation regimen. This study compared the consequences of CP in patients who underwent anticoagulation with bivalirudin (BIV; a nonreversible direct thrombin inhibitor with a shorter 1/2-life than heparin) to those in patients who underwent anticoagulation with heparin (HEP) at time of CP. Patients with CP were identified from 33,613 procedures available in our institutional angioplasty registry. The outcome of this group was compared based on anticoagulation regimen (BIV vs HEP). The primary end point for this analysis was the composite of in-hospital death, cardiac tamponade, or emergency cardiac surgery. Overall a cohort of 69 patients (0.2%) with CP was identified. BIV was the intraprocedural anticoagulant in 41 patients, whereas HEP was used in 28. Baseline characteristics were comparable between groups except for a higher frequency of systemic hypertension and hypercholesterolemia in the BIV group. Procedural characteristics were also similar including lesion complexity and perforation severity. Nearly 1/2 of CPs in each group was managed with prolonged balloon inflation alone. Protamine was used in 46% of HEP-treated patients. Covered stents tended to be used more frequently in the BIV group (p = 0.061). The primary composite end point was similar between groups (odds ratio 1.42, 95% confidence interval 0.47 to 4.29, p = 0.53). However, there was a lower rate of cardiac surgery requirement in BIV-treated patients (p = 0.037). In conclusion, our study suggests that choice of procedural anticoagulant agent does not influence outcome when CP occurs. Therefore, use of BIV should not be discouraged in patients undergoing high-risk intervention for perforations.

Evaluation of multislice computed tomography early after transcatheter aortic valve implantation with the Edwards SAPIEN bioprosthesis.

Currently, imaging assessment of patients who undergo transcatheter aortic valve implantation is based mainly on echocardiography and angiography, both limited to provide a 3-dimensional evaluation of the prosthesis within the native valve. This study involved 34 patients who underwent multislice computed tomography (MSCT) after transcatheter aortic valve implantation. Prosthesis expansion and circularity, depth of implantation, apposition degree at the ventriculoaortic junction, and positioning in relation to coronary artery ostia were evaluated. Early clinical events such as aortic regurgitation and periprocedural conduction abnormalities were recorded and correlated with multislice computed tomographic findings. MSCT provided comprehensive 3-dimensional assessments of the prostheses in 31 of 34 of patients (91%). Expansion was excellent (mean expansion ratio 100.0 ± 10.4%) and increased significantly from the ventricular side to the aortic side of the prosthesis. Circular deployment was achieved in most patients and increased from the ventricular to the aortic side. Mean implantation depth was -2.4 ± 2.5 mm, associated with a low rate (12%) of permanent pacemaker implantation. Patients with a new conduction abnormalities had the deepest prosthesis implantation, associated with lesser expansion and circularity. Perfect apposition on MSCT was associated with a low rate of significant aortic regurgitation. In conclusion, MSCT is able to provide an accurate 3-dimensional evaluation of prosthesis deployment and positioning after transcatheter aortic valve implantation. Moreover, these anatomic findings correlate with the most frequent early complications (i.e., the occurrence of aortic regurgitation and conduction abnormalities).

Comparison between Society of Thoracic Surgeons score and logistic EuroSCORE for predicting mortality in patients referred for transcatheter aortic valve implantation.

BACKGROUND: The primary inclusion criteria from both the Society of Thoracic Surgeons (STS) score and the logistic EuroSCORE are currently used to identify high-risk and inoperable patients eligible for transcatheter aortic valve implantation (TAVI). We aimed to examine the correlation between STS and logistic EuroSCOREs and their performance characteristics in patients referred for TAVI. METHODS: The study cohort consisted of 718 high-risk patients with severe aortic stenosis who were considered for participation in a TAVI clinical trial. The performance of the STS and logistic EuroSCOREs was evaluated in three groups: (a) medical management or balloon aortic valvuloplasty (BAV), 474 (66%); (b) 133 patients (18.5%) with surgical aortic valve replacement (AVR); (c) 111 (15.4%) with TAVI. The mean age was 81.8 ± 8.1 years, and 394 (54.8%) were female. RESULTS: The mean STS score was 11.5 ± 6.1, and the mean logistic EuroSCORE was 39.7 ± 23.0. Pearson correlation coefficient showed moderate correlation between the STS and logistic EuroSCOREs (r = 0.61, P < .001). At a median follow-up of 190 days (range, 67-476), 282 patients (39.2%) died. The STS and logistic EuroSCOREs were both higher in patients who died as compared to those in survivors (13.1 ± 6.2 vs.10.0 ± 5.8 and 43.4 ± 23.1 vs. 37.5 ± 22, respectively; P < .001). The observed and predicted 30-day mortality rates in the medical/BAV group were 10.1% observed, 12.3% by STS and 43.1% by logistic EuroSCORE. In the surgical AVR group, the rates were 12.8% observed, 8.4% by STS and 25.6% by logistic EuroSCORE. In the TAVI group, the rates were 11.7% observed, 11.8% by STS and 41.2% by logistic EuroSCORE. The odds ratio (OR) for 30-day mortality in the medical/BAV group was 1.05 (P = .01) with STS and 1.003 (P = .7) with logistic EuroSCORE. In the surgical AVR group, the OR was 1.09 (P = .07) with STS and 1.007 (P = .6) with logistic EuroSCORE. In the TAVI group, the OR was 1.14 (P = .03) with STS and 1.03 (P = .04) with logistic EuroSCORE. CONCLUSION: In high-risk patients with severe aortic stenosis, STS score is superior to the logistic EuroSCORE in predicting mortality. Clinical judgment should play a major role in the selection of patients with severe aortic stenosis for the different therapeutic options.