Pacing Dependency Following TAVI
Background
Conduction disorders requiring permanent pacemaker (PPM) implantation are a known complication of transcatheter aortic valve implantation (TAVI). ...Indications for permanent pacing in this setting are still controversial. The study aim was to characterize the natural history of conduction disorders related to TAVI, and to identify predictors for long‐term pacing dependency.
Methods
Consecutive patients who underwent TAVI were included in this prospective observational study. The conduction system was investigated by reviewing 12‐lead ECGs during hospitalization and up to 1‐year follow‐up and by analyzing pacemaker interrogation data. Multivariate analysis was performed in order to identify independent predictors for pacemaker dependency.
Results
Of 110 patients included in the analysis, 38 (34.5%) underwent PPM implantation. Of those, 26 (68.4%) had a long‐term pacing dependency (required PPM), while 12 (31.6%) did not (not‐required PPM). Logistic regression revealed that baseline RBBB (P = 0.01, OR = 18.0), baseline PR interval (P = 0.019, OR = 1.14), post‐TAVI PR interval and the change in PR interval from baseline (P < 0.001 for both, OR = 1.17 for each 10 milliseconds increment) were independent predictors for long‐term pacing dependency. A PR interval increment of greater than 28 milliseconds had the best accuracy in predicting pacemaker dependency.
Conclusions
Increased pre‐ and postprocedural PR intervals and pre‐existing RBBB are reliable predictors for long‐term PPM dependency, while left bundle branch block or QRS width are misleading factors. Our study suggests that the decision for implanting PPM after TAVI should be based mostly on the prolongation of the PR interval.
This study evaluated the results of transcatheter aortic valve replacement (TAVR) in bicuspid aortic stenosis (AS) using a new-generation TAVR device.
A bicuspid AS is often considered a relative ...contraindication to TAVR. Although initial reports have demonstrated feasibility using early-generation devices, outcomes have not matched those seen with tricuspid AS. Paravalvular aortic regurgitation (AR) has been particularly problematic.
We collected baseline characteristics, procedural data, and 30-day clinical follow-up findings from 8 centers in Europe and Canada that had performed TAVR in bicuspid AS using the SAPIEN 3 valve.
51 patients underwent TAVR using the SAPIEN 3 valve. Patient mean age was 76.2 ± 9.3 years and the Society of Thoracic Surgeons predicted risk of mortality scores were 5.2 ± 3.7%. Bicuspid valve types were: type 0, 11.8%; type 1, 82.3%; and type 2, 1.9%. There were no cases of valve embolization or need for a second valve. Post-dilation was performed in 7.8%. The mean aortic gradient decreased from 49.4 ± 16.0 mm Hg to 11.2 ± 4.7 mm Hg. Post-implantation AR was none/trivial in 63% and mild in 37%. There were no cases of moderate or severe AR. At 30-day follow-up, there were 2 deaths (3.9%), 2 major vascular complications, and 12 patients (23.5%) required pacemaker implantation.
TAVR in bicuspid AS using a new-generation device was feasible and effective with favorable valve performance and no cases of moderate or severe AR.
Transcatheter aortic valve implantation in bicuspid aortic valve stenosis Perlman, Gidon Y; Blanke, Philipp; Webb, John G
EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,
09/2016, Letnik:
12, Številka:
Y
Journal Article
Recenzirano
Bicuspid aortic stenosis (AS) is not rare in patients treated with transcatheter aortic valve implantation (TAVI). Bicuspid valves have unique anatomy which could affect the results of TAVI; however, ...multiple recent reports have shown that TAVI is safe and effective in this population. Paravalvular aortic regurgitation was initially found to be more frequent in bicuspid patients, but newer-generation devices have shown superior results in this respect. Higher rates of pacemaker implantation after TAVI in bicuspid AS do require further investigation. Current data suggest that bicuspid valves should not be a contraindication for TAVI, but future specific trials are needed to support this assertion.
Tricuspid regurgitation (TR) is common and undertreated as the risk of surgery is high in this patient population. Transcatheter devices offer treatment with a lower procedural risk. The FORMA ...Tricuspid Valve Therapy system (Edwards Lifesciences) will be reviewed here.
The system combines a spacer placed in the regurgitant orifice and a rail, over which the spacer is delivered, that is anchored to the endocardial surface of the RV. The spacer provides a surface for leaflet coaptation.
Eighteen compassionate care patients and 29 patients included in the US EFS trial are reviewed. Patients were elderly (76 years) and high risk (Euroscore 2 was 9.0 and 8.1%, respectively). There were 2 procedural failures in both groups. Mortality at 30 days was 0% in the compassionate group and 7% in the EFS trial. TR was reduced in both groups; 2D/3D EROA 2.1 ± 1.8 to 1.1 ± 0.9 cm
in the EFS trial and vena contracta width 12.1 ± 3.3 to 7.1 ± 2.2 mm. Symptomatic improvement was seen in both groups; the proportion of patients in NYHA class III/IV decreased from 84 to 28% at 30 days in the EFS group, and from 94 to 21% at 1 year, in the compassionate group.
Reduction of TR with FORMA system is feasible and sustained. Despite residual TR post-procedure, the significant relative reduction in TR severity contributes to substantial clinical improvements in patients with a FORMA device in place.
The authors sought to investigate the impact of diabetes mellitus (DM) on outcomes following contemporary drug-eluting stent (DES) implantation in the BIONICS (BioNIR Ridaforolimus Eluting Coronary ...Stent System in Coronary Stenosis) trial.
Patients with DM are at increased risk for adverse events following percutaneous coronary intervention (PCI).
A prospective, multicenter, 1:1 randomized trial was conducted to evaluate in a noninferiority design the safety and efficacy of ridaforolimus-eluting stents versus zotarolimus-eluting stents among 1,919 patients undergoing PCI. Randomization was stratified to the presence of medically treated DM, and a pre-specified analysis compared outcomes according to the presence or absence of DM up to 2 years.
The overall prevalence of DM was 29.1% (559 of 1,919). DM patients had higher body mass index, greater prevalence of hyperlipidemia and hypertension, and smaller reference vessel diameter. One-year target lesion failure (cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization) was significantly higher among diabetic patients (7.8% vs. 4.2%; p = 0.002), mainly due to higher target lesion revascularization (4.5% vs. 2.0%; p = 0.002). Rates of cardiac death, myocardial infarction, and stent thrombosis did not statistically vary. Among 158 patients undergoing 13-month angiographic follow-up, restenosis rates were 3 times higher in diabetic patients compared with nondiabetic patients (15.2% vs. 4.7%; p = 0.01). Clinical and angiographic outcomes were similar between ridaforolimus-eluting stent- and zotarolimus-eluting stent-treated patients.
Despite advances in interventional therapies, and the implementation of new-generation DES, diabetic patients still have worse angiographic and clinical outcomes compared with nondiabetic patients undergoing PCI.
Introduction
Percutaneous mitral valve repair (PMVR), such as MitraClip, is performed on high‐risk patients and involves hemodynamic alternations that may cause acute kidney injury (AKI). We aimed to ...evaluate the incidence of AKI, predictors for developing AKI and the correlation with mortality after MitraClip.
Methods
We performed a retrospective analysis of collected data from patients who underwent PMVR in two tertiary medical centers in Israel to identify factors associated with AKI.
Results
The study population included 163 patients. The median age was 77 years; 60.7% of patients were male. The median eGFR significantly decreased post‐procedure from 49 (35–72) to 47.8 (31–65.5) ml/min/1.73 m2 (p < .001). Forty‐seven patients (29%) developed AKI. None of the patients who developed AKI required hemodialysis. Predictors of AKI included: baseline eGFR ≤30 ml/min/1.73 m2, severity of residual MR, TMPG>5 mmHg, diuretic use, and re‐do procedures. Among the patients who developed AKI there was an improvement in kidney function during follow‐up, and creatinine levels significantly decreased from a peak mean creatinine of 179.5 (143–252) mmol/l to 136 (92–174) mmol/l (p < .001). However, 19% (9 out of 47) of patients experienced partial recovery and their creatinine level, when compared to their baseline, remained elevated. One‐year survival showed a trend for increased mortality among patients who developed AKI (86.2% vs. 80.9%, p = .4), and patients who developed AKI that persisted had increased 1‐year mortality compared with patients that had recovered their kidney function (86.8% vs. 55.6%, p = .01).
Conclusion
The incidence of AKI after MitraClip is high. AKI is reversible in most patients; however, the persistence of kidney injury is associated with increased 1‐year mortality.
BACKGROUND:The safety and efficacy of a novel cobalt alloy-based coronary stent with a durable elastomeric polymer eluting the antiproliferative agent ridaforolimus for treatment of patients with ...coronary artery disease is undetermined.
METHODS:A prospective, international 1:1 randomized trial was conducted to evaluate in a noninferiority design the relative safety and efficacy of ridaforolimus-eluting stents (RESs) and slow-release zotarolimus-eluting stents among 1919 patients undergoing percutaneous coronary intervention at 76 centers. Inclusion criteria allowed enrollment of patients with recent myocardial infarction, total occlusions, bifurcations lesions, and other complex conditions.
RESULTS:Baseline clinical and angiographic characteristics were similar between the groups. Overall, mean age was 63.4 years, 32.5% had diabetes mellitus, and 39.7% presented with acute coronary syndromes. At 12 months, the primary end point of target lesion failure (composite of cardiac death, target vessel-related myocardial infarction, and target lesion revascularization) was 5.4% for both devices (upper bound of 1-sided 95% confidence interval 1.8%, Pnoninferiority=0.001). Definite/probable stent thrombosis rates were low in both groups (0.4% RES versus 0.6% zotarolimus-eluting stent, P=0.75); 13-month angiographic in-stent late lumen loss was 0.22±0.41 mm and 0.23±0.39 mm (Pnoninferiority=0.004) for the RES and zotarolimus-eluting stent groups, respectively, and intravascular ultrasound percent neointimal hyperplasia was 8.10±5.81 and 8.85±7.77, respectively (Pnoninferiority=0.01).
CONCLUSIONS:In the present trial, which allowed broad inclusion criteria, the novel RESs met the prespecified criteria for noninferiority compared with zotarolimus-eluting stents for the primary end point of target lesion failure at 12 months and had similar measures of late lumen loss. These findings support the safety and efficacy of RESs in patients who are representative of clinical practice.
CLINICAL TRIAL REGISTRATION:URLhttp://www.clinicaltrials.gov. Unique identifierNCT01995487.
This study sought to investigate the blood pressure (BP) response after transcatheter aortic valve implantation (TAVI) and its correlation with short- and mid-term clinical outcomes.
TAVI is an ...emerging therapy for aortic stenosis patients at high surgical risk. The acute hemodynamic sequelae of this procedure and their clinical relevance are yet unclear.
Consecutive patients who underwent TAVI in a single center were prospectively monitored for BP response during 5 post-procedural days. Clinical parameters, adverse events, and medical treatment were recorded during hospitalization, at 30 days, and at 12 months after the procedure. Patients were divided according to their post-procedural BP response into 2 groups: increased BP and stable BP.
One hundred and five patients were analyzed. Overall, systolic BP increased immediately after TAVI in the entire cohort by an average of 15 ± 31 mm Hg. This rise was sustained and led to intensification of antihypertensive treatment in 53 patients (51%); these patients were designated as the increased BP group. The increase in systolic BP after TAVI was associated with an increase in stroke volume and cardiac output and was not related to age, baseline cardiac function, or procedural outcomes. Patients with increased BP after TAVI had a significantly better prognosis with fewer adverse events in the hospital (21% vs. 62%, p < 0.01), after 30 days (30% vs. 71%, p < 0.01), and after 12 months (53% vs. 83%, p < 0.01) as compared with patients with stable BP.
After TAVI, a substantial number of patients have a significant rise in systolic BP necessitating long-term treatment. This increase in BP is associated with an increase in cardiac output and predicts a better clinical outcome.
CT measurement of supra-annular area (SA) has been proposed as an alternative to annular area (AA) for sizing of trancatheter valves in biscuspid aortic valves (BAV). This study examines the ...reproducibility of SA and AA measurements and their potential impact on downstream transcatheter heart valve sizing and clinical outcomes.
44 consecutive patients (mean age: 73 ± 15 years, 57% male) undergoing CTA with subsequent SAPIEN 3 valve insertion for severe bicuspid aortic stenosis (AS) were included. AA was measured at the basal ring. SA was measured by generating a circle defined by the intercommisural distance. AA and SA were measured by 2 independent observers. Baseline characteristics, TAVR procedural data, and discharge echocardiography data were collected.
The SA was significantly larger than the AA (562 ± 146mm2 vs. 518 ± 112mm2,p = 0.013). Interobserver agreement was high using both techniques (ICC AA = 0.98,p < 0.001; SA = 0.80,p < 0.001), but with narrower limits of agreement with AA measurements (mean difference (limits of agreement): AA = −3mm2 (22; 19), SA = −16mm2 (−92; 76)). AA-based device sizing demonstrated substantial agreement with final valve inserted (κ = 0.72,p < 0.001), while SA demonstrated fair agreement (κ = 0.40,p < 0.001). There was no difference in post TAVR gradients, paravalvular leakage or valve success between patients with concordant sizing between AA and SA, and those in whom SA would have suggested an alternate valve size.
Supra-annular sizing is less reproducible than annular sizing, with no difference in procedural complication rates in patients in whom supra-annular sizing would have altered the device size used. These results suggest no role for supra-annular sizing in current clinical practice.
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