Objectives This study aimed to determine the success, complications, and survival of patients after balloon aortic valvuloplasty (BAV). Background The introduction of transcatheter aortic valve ...implantation (TAVI) BAV has led to a revival in the treatment of patients with severe aortic stenosis. Methods A cohort of 262 patients with severe aortic stenosis underwent 301 BAV procedures. Of these, 39 (14.8%) patients had ≥2 BAV procedures. Clinical, hemodynamic, and follow-up mortality data were collected. Results The cohort mean age was 81.7 ± 9.8 years, and the mean Society of Thoracic Surgeons and logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) was 13.3 ± 6.7 and 45.6 ± 21.6, respectively. BAV was performed as a bridge to TAVI or to surgical aortic valve replacement in 28 patients (10.6%) and for symptom relief in 234 (89.4%). The mean aortic valve area (AVA) increased from 0.58 ± 0.3 cm2 to 0.96 ± 0.3 cm2 (p < 0.001). Of these, 111 (45.0%) had final AVA >1 cm2 , and in 195 patients (79%), AVA increased by >40%. De novo BAV resulted in a higher mean increase in AVA 0.41 ± 0.24 cm2 versus 0.28 ± 0.24 cm2 in redo BAV (p = 0.003). Serious adverse events occurred in 47 patients (15.6%), intraprocedural death in 5 (1.6%), stroke in 6 (1.99%), coronary occlusion in 2 (0.66%), severe aortic regurgitation in 4 (1.3%), resuscitation/cardioversion in 5 (1.6%), tamponade in 1 (0.33%), and permanent pacemaker in 3 (0.99%). A vascular complication occurred in 21 patients (6.9%); 34 (11.3%) had a post-procedure rise in creatinine >50%; and 3 (0.99%) required hemodialysis. During median follow-up of 181 days, the mortality rate was 50% (n = 131). The mortality rate in the group with final AVA >1 cm2 was significantly lower than in the group with final AVA of <1 cm2 (36.4% vs. 57.9%, p < 0.001). Final AVA was associated with lower mortality (hazard ratio: 0.46, p = 0.03). BAV as a bridge to TAVI or surgical aortic valve replacement had a better outcome compared with BAV alone: mortality rate 7 (25%) versus 124 (52.9%), respectively (p < 0.0001). Conclusions Long-term survival is poor after BAV alone. BAV as a bridge to percutaneous or surgical aortic valve replacement is feasible, safe, and associated with better outcome than BAV alone.
Role of CMR in TAVR Rogers, Toby, BM, BCh; Waksman, Ron, MD
JACC. Cardiovascular imaging,
05/2016, Volume:
9, Issue:
5
Journal Article
Peer reviewed
Open access
Abstract Multimodality imaging plays a critical role in planning, performing, and evaluating transcatheter aortic valve replacement (TAVR). Cardiovascular magnetic resonance (CMR) has been ...underutilized in this patient population to date, but there is increasing evidence that it can offer equivalent or even superior information to more commonly used imaging modalities, such as echocardiography or computed tomography for specific applications. In addition, CMR can provide incremental information, including advanced tissue characterization with late gadolinium enhancement and T1 mapping. In this paper, we review the evidence for CMR in TAVR and explore whether CMR should still be considered a research tool, or whether it is now ready for implementation into clinical practice.
Abstract We sought to determine whether balloon-expandable (BEV) and self-expanding (SEV) valves affect valve hemodynamics differently according to native aortic annulus size. TAVR can achieve ...superior prosthetic valve hemodynamics compared with SAVR, particularly in patients with small aortic annulus. 193 consecutive TAVR patients were grouped into tertiles defined by CT angiography-derived aortic annulus systolic perimeter. The pre-discharge echocardiogram was analyzed for prosthetic valve hemodynamics. Tertile perimeter cutoffs were 73mm and 80mm. STS score decreased as annulus size increased (7.8% vs. 7.6% vs. 6.0%, p=<0.05 for small, medium and large annulus, respectively). In patients with small aortic annulus, SEV was associated with significantly higher dimensionless index (0.64 vs. 0.53, p=0.02) and lower peak velocity (1.8 vs. 2.4m/sec, p<0.001), and a trend toward lower mean gradient (7.5 vs. 10.0mmHg, p=0.07) compared with BEV. These differences were attenuated and absent in patients with medium and large annulus, respectively. Few patients had moderate/severe paravalvular leak, with no association with valve type or annulus size. There was no difference in mortality between tertiles or valve type at 30 days or 1 year. There was no association between aortic annulus perimeter and 1-year mortality by univariate analysis (HR 1.00, 95% CI 0.95-1.05, p=0.86) or multivariate analysis (HR 1.02, 95% CI 0.95-1.09, p=0.60). In conclusion, SEV hemodynamics were superior to BEV in patients with small aortic annulus. This difference was diminished in patients with larger aortic annulus. This study highlights the importance of valve selection in patients with small aortic annulus.
Abstract The use of intravascular ultrasound (IVUS) guidance for drug-eluting stent (DES) optimization is limited by the number of adequately powered randomized control trials (RCTs). We performed an ...updated meta-analysis, including data from recently published RCTs and observational studies, by reviewing the literature in Medline and the Cochrane Library to identify studies that compared clinical outcomes between IVUS-guided and angiography-guided DES implantation from January 1995 to January 2016. This meta-analysis included 25 eligible studies, including 31,283 patients, of whom 3192 patients were enrolled in 7 RCTs. In an analysis of all 25 studies, the summary results for all the events analyzed were significantly in favor of IVUS-guided DES implantation major adverse cardiac events (MACE, odds ratio OR 0.76, 95% confidence intervals CI: 0.70–0.82, P < 0.001); death (OR 0.62, 95% CI: 0.54–0.72, P < 0.001); myocardial infarction (OR 0.67, 95% CI: 0.56–0.80, P < 0.001); stent thrombosis (OR 0.58, 95% CI: 0.47–0.73, P < 0.001); target lesion revascularization (TLR, OR 0.77, 95% CI: 0.67–0.89, P = 0.005); target vessel revascularization (TVR, OR 0.85, 95% CI: 0.76–0.95, P < 0.001). However, in a separate analysis of RCTs, a favorable result for IVUS-guided DES implantation was found only for MACE (OR 0.66, 95% CI: 0.52–0.84, P = 0.001), TLR (OR 0.61, 95% CI: 0.43–0.87, P = 0.006), and TVR (OR 0.61, 95% CI: 0.41–0.90, P = 0.013). IVUS-guided percutaneous coronary intervention was associated with better overall clinical outcomes than angiography-guided DES implantation. However, in a solely RCT meta-analysis, this benefit was mainly driven by reduced rates of revascularizations.
Summary Background Coronary stents improve immediate and late results of balloon angioplasty by tacking up dissections and preventing wall recoil. These goals are achieved within weeks after ...angioplasty, but with current technology stents permanently remain in the artery, with many limitations including the need for long-term antiplatelet treatment to avoid thrombosis. We report a prospective multicentre clinical trial of coronary implantations of absorbable magnesium stents. Methods We enrolled 63 patients (44 men; mean age 61·3 SD 9·5 years) in eight centres with single de novo lesions in a native coronary artery in a multicentre, non-randomised prospective study. Follow-up included coronary angiography and intravascular ultrasound at 4 months and clinical assessment at 6 months and 12 months. The primary endpoint was cardiac death, non-fatal myocardial infarction, or clinically driven target lesion revascularisation at 4 months Findings 71 stents, 10–15 mm in length and 3·0–3·5 mm in diameter, were successfully implanted after pre-dilatation in 63 patients. Diameter stenosis was reduced from 61·5 (SD 13·1%) to 12·6 (5·6%) with an acute gain of 1·41 mm (0·46 mm) and in-stent late loss of 1·08 mm (0·49 mm). The ischaemia-driven target lesion revascularisation rate was 23·8% after 4 months, and the overall target lesion revascularisation rate was 45% after 1 year. No myocardial infarction, subacute or late thrombosis, or death occurred. Angiography at 4 months showed an increased diameter stenosis of 48·4 (17·0%). After serial intravascular ultrasound examinations, only small remnants of the original struts were visible, well embedded into the intima. Neointimal growth and negative remodelling were the main operating mechanisms of restenosis. Interpretation This study shows that biodegradable magnesium stents can achieve an immediate angiographic result similar to the result of other metal stents and can be safely degraded after 4 months. Modifications of stent characteristics with prolonged degradation and drug elution are currently in development.
Objectives
The Multi‐center Prospective Study to Evaluate Outcomes of Moderate to Severely Calcified Coronary Lesions (MACE—Trial) was designed to provide further insight on the impact of ...calcification on procedural and long‐term percutaneous coronary intervention outcomes.
Background
Prior studies evaluating the impact of lesion calcification on percutaneous coronary intervention outcomes are limited by: retrospective nature, pooled data from multiple studies, or lack of specificity around calcification with only operator assessment and without core lab evaluation.
Methods
The MACE‐Trial was a prospective, multicenter, observational clinical study that enrolled 350 subjects at 33 sites from September 2013 to September 2015. Core lab assessed subject stratification by lesion calcification (none/mild N = 133, moderate N = 99, and severe N = 114). Endpoints were lesion success, procedural success, and 1‐year major adverse cardiac events (MACEs).
Results
Presence of severe calcification had significant impact on lesion success (83.3% versus none/mild calcification 94.7%, P = 0.006) and procedural success (86.8% versus moderate 95.0%, P = 0.028, and none/mild 97.7%, P = 0.001). 1‐year MACE rates were associated with presence of calcification in subjects with none/mild (4.7%), moderate (8.7%), and severe (24.4%) (P < 0.001) calcification; however, no difference was noted between none/mild and moderate (P = 0.237). The risk adjusted multivariable model identified severe calcification and decreasing eGFR as predictors of 30‐day and 1‐year MACE.
Conclusions
In this prospective study, patients with severe calcification had significantly worse outcomes compared to those without; however, unlike previous retrospective studies, moderate calcium resulted in similar outcomes as none/mild calcium.
Clinical Trial Registration
URL: https://clinicaltrials.gov/ct2/show/NCT01930214. Unique Identifier: NCT01930214.
Although the safety profiles of coronary stents eluting sirolimus or paclitaxel do not seem to differ from those of bare metal stents in the short-to-medium term, concern has arisen about the ...potential for late stent thromboses related to delayed endothelialisation of the stent struts. We report four cases of angiographically-confirmed stent thrombosis that occurred late after elective implantation of polymer-based paxlitaxel-eluting (343 and 442 days) or sirolimus-eluting (335 and 375 days) stents, and resulted in myocardial infarction. All cases arose soon after antiplatelet therapy was interrupted. If confirmed in systematic long-term follow-up studies, our findings have potentially serious clinical implications.
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