Predictors of clinical outcomes after edge-to-edge percutaneous mitral valve repair.

BACKGROUND: There is limited information on the long-term outcomes and prognostic clinical predictors after edge-to-edge transcatheter mitral valve repair with the MitraClip system. METHODS: Consecutive patients with mitral regurgitation (MR) undergoing MitraClip therapy between October 2008 and November 2013 in 4 Italian centers were analyzed. The primary end point of interest was all-cause death. The secondary end point was the composite of all-cause death or rehospitalization for heart failure. RESULTS: A total of 304 patients were included, of which 79% had functional MR and 17% were in New York Heart Association functional class IV. Acute procedural success was obtained in 92% of cases, with no intraprocedural death. The cumulative incidences of all-cause death were 3.4%, 10.8%, and 18.6% at 30 days, 1 year, and 2 years, respectively. The corresponding incidences of the secondary end point were 4.4%, 22.0%, and 39.7%, respectively. In the Cox multivariate model, New York Heart Association functional class IV at baseline and ischemic MR etiology were found to significantly and independently predict both the primary and the secondary end point. A baseline, left ventricular end-systolic volume >110 mL was found to be an independent predictor of the secondary endpoint. Acute procedural success was independently associated with a lower risk of all-cause death and the combination of all-cause death or rehospitalization for heart failure at long-term follow-up. CONCLUSIONS: In a cohort of patients undergoing MitraClip therapy, those presenting at baseline with ischemic functional etiology, severely dilated ventricles, or advanced heart failure and those undergoing unsuccessful procedures carried the worst prognosis.

A rare but serious complication of ticagrelor therapy: a case report.

BACKGROUND: Ticagrelor is a widely used P2Y12 inhibitor and represents a fundamental therapeutic agent in acute coronary syndrome treatment and selected post-percutaneous coronary intervention (PCI) cases. Dyspnoea and bradycardia are the most common side effects but the latter has been reported to be of trivial clinical significance. CASE SUMMARY: A 51-year-old gentleman underwent PCI to left anterior descending and obtuse marginal for unstable angina receiving a loading dose of ticagrelor (180 mg). During hospital stay, whilst on telemetry monitoring, a 16 s long, symptomatic, asystolic ventricular standstill was recorded prompting ticagrelor interruption and a switch to prasugrel. DISCUSSION: Despite ventricular pauses have been reported in dedicated analyses of Phase III trials, no apparent clinical consequences were documented. However, several reports have shown that significant brady-arrhythmic events might be linked to ticagrelor administration presenting both as sino-atrial and atrio-ventricular conduction disturbances. We report a case of asystole occurring 36 h after the administration of a loading dose.

Comparison of three contemporary surgical scores for predicting all-cause mortality of patients undergoing percutaneous mitral valve repair with the MitraClip system (from the multicenter GRASP-IT registry).

The aim of this study was to explore the adaptability of 3 contemporary surgical scores (Logistic EuroSCORE [LES], EuroSCORE II [ESII], and Society of Thoracic Surgeons Predicted Risk of Mortality [STS-PROM]) for prediction of mortality after percutaneous mitral valve repair with the MitraClip system. A total of 304 patients from the multicenter Getting Reduction of mitrAl inSufficiency by Percutaneous clip implantation in ITaly registry (GRASP-IT) were stratified based on LES, ESII, and STS-PROM tertiles and analyzed by different measurements of discrimination, calibration, and global accuracy with focus on 30-day and 1-, 2-, and 3-year mortality. A statistically significant gradient in the distribution of mortality was observed at all time points with ESII, at 2 years with LES, and at 2 and 3 years with STS-PROM. ESII had the best discrimination at 30 days (C-statistic 0.80), which remained acceptable at later follow-up, being significantly superior to that of LES at each time point (p = 0.003 at 30 days, p = 0.005 at 1 year, p = 0.011 at 2 years, and p = 0.029 at 3 years). Compared with STS-PROM, ESII showed better discrimination at 30 days (C-statistic 0.80 vs 0.62, p = 0.023). All scores overpredicted the risk of mortality at 30 days and were miscalibrated at 2 and 3 years. At 1 year, there was a good agreement between the observed and predicted probabilities for ESII and STS-PROM, whereas LES remained overpredictive. ESII showed the best global accuracy at 30 days and 1 year, whereas no notable differences were noted versus LES and STS-PROM at 2 and 3 years. In conclusion, lacking specific tools for risk stratification of patients undergoing MitraClip implantation, ESII holds favorable prognostic characteristics, which makes it a valid surrogate.

Right subclavian approach as a feasible alternative for transcatheter aortic valve implantation with the CoreValve ReValving System.

AIMS: Arterial access selection is crucial during transcatheter aortic valve implantation. When traditional femoral access has been deemed unfeasible the left subclavian artery has been used successfully. In cases where even the latter was ineligible, we opted, despite the lack of any data, for the right subclavian approach. We hereby present the results of the first series available. Our aim was to evaluate the feasibility and performance of the CoreValve ReValving System (CRS) implantation via the right subclavian artery in patients with contraindication to femoral and left subclavian accesses. METHODS AND RESULTS: Among 300 patients who have undergone CRS implantation, 70 (23%) have been treated via the subclavian approach, 10 via the right subclavian artery and 60 via the left. Demographic features were quite similar except for the presence of significant left subclavian disease in all patients treated via the right subclavian artery. The success rate was 100% for both groups. At 30-day follow-up, there was no significant difference in terms of all-cause mortality and cardiac mortality between right vs. left subclavian approach (0% vs. 6.6% and 0% vs. 6.6%, respectively). Consistent results were observed at a mean follow-up of 12±7.9 months (all-cause mortality: 10% vs. 15%). Incidences of new AV block requiring PM implantation were also statistically equivalent. CONCLUSIONS: CRS implantation via the right subclavian artery was as feasible and safe as the left subclavian approach. It poses very particular technical issues but should be considered when more conventional approaches are inadequate in order to provide patients with a further chance to be treated effectively.

Transcatheter valve-in-valve implantation using Corevalve Revalving System for failed surgical aortic bioprostheses.

OBJECTIVES: The purpose of this study was to evaluate the performance of CoreValve Revalving System (CRS) (Medtronic, Minneapolis, Minnesota) implantation in patients with failed aortic bioprostheses. BACKGROUND: Transcatheter aortic valve implantation with the CRS is an effective option in high-risk patients with severe aortic stenosis. It may be an option for patients with a failed aortic bioprosthesis, especially when the risk of a surgical redo is deemed prohibitive. METHODS: CRS "valve-in-valve" implantation was performed in 25 high-risk patients with a failed bioprosthesis. Their mean age was 82.4 ± 3.2 years. New York Heart Association functional classes III and IV were present in 21 and 4 patients, respectively. The logistic EuroSCORE was 31.5 ± 14.8%, whereas the Society of Thoracic Surgeons score was 8.2 ± 4.2. Patients/prostheses were divided in type A (mainly stenotic, n = 9) and type B (mainly regurgitant, n = 16). RESULTS: The implantation success rate was 100%. In group A, the peak aortic gradient significantly decreased from 77.6 ± 21.6 mm Hg to 34.6 ± 19.4 mm Hg (p = 0.001). In all but 2 patients in group B, no significant regurgitation was observed post-implantation. No patients died during the procedure. At 30 days, there were 3 deaths (12%), 2 myocardial infarctions (8%), and 3 atrioventricular blocks requiring pacemaker implantation (12%). At a mean follow-up of 6 months, there were another death (survival rate of 84%) and a pacemaker implantation (cumulative incidence of 16%). New York Heart Association functional class improved in all patients to I and II. CONCLUSIONS: CRS implantation was feasible and effective regardless of the prevalent mode of failure. This finding may significantly affect the treatment of patients with a failed bioprosthesis deemed at a prohibitive risk for surgical redo.

Drug eluting stents versus bare metal stents in the treatment of saphenous vein graft disease: a systematic review and meta-analysis.

AIMS: Treatment of saphenous vein graft (SVG) disease is still a matter of debate given the uncertainty of the available conflicting data. Our aim was to assess, by means of a meta-analytic approach, the risk/benefit profile of drug eluting stents (DES) versus bare metal stents (BMS) in the treatment of SVG disease. METHODS AND RESULTS: A search of relevant studies in several databases was performed. The endpoints of interest such as: major adverse events (MAE) (the combination of overall death and non-fatal myocardial infarction [AMI]), target vessel revascularisation (TVR), and target lesion revascularisation (TLR) have been calculated in-hospital and at the longest follow-up. Single endpoints and the rate of stent thrombosis (ST) were also assessed. Three randomised controlled trials and 15 registry studies were appraised, totalling 3,294 patients. During hospitalisation, there was no difference in the risk of MAE, overall death, AMI and TVR. No data were available to calculate the TLR rate. At a mean follow-up of 19.8 months, no significant differences were found in the risk of MAE and AMI. BMS were associated with a trend towards a higher risk of overall death (OR 1.32 [1,00-1.74], p=0.05, number needed to treat [NNT]=55). DES showed superiority in terms of TVR (OR 1.86 [1.33-2.61], p=0.0003, NNT=16), and TLR (OR 1.77 [1.27-2.48], p<0.0001, NNT=25). According to pre-specified subgroup analyses, these effects seem less evident at the long-term follow-up. DES were not associated with an increased risk of ST. CONCLUSIONS: Use of DES in SVG substantially reduces both TVR and TLR. These data also demonstrate that using DES in SVG is safe and contradict previous reports of potential risks.

Acquired pulmonary vein stenosis after radiofrequency ablation treated by angioplasty and stent implantation.

OBJECTIVE: Pulmonary vein (PV) stenosis is a late complication of radiofrequency ablation for atrial fibrillation. Although frequently asymptomatic, it can be associated with severe respiratory symptoms that cause significant morbidity. This study evaluated the role of angioplasty and stent implantation in patients affected by acquired PV stenosis. METHODS: Between June 2003 and June 2004, six patients with seven acquired iatrogenic PV stenoses, documented by multislice computed tomography scanning, underwent catheterisation and angiography at the St. Ambrogio Clinical Institute, Milan, Italy. RESULTS: The median duration between radiofrequency ablation and the reported onset of respiratory symptoms was 13.5 months (interquartile range 6.7-22.2 months). All of patients were symptomatic (New York Heart Association functional class II or III). Five PV stenoses were treated by angioplasty and stent implantation. In one patient, the procedure was not performed because of endoluminal thrombosis and in another one recanalisation of occluded PV was unsuccessful. At angiography overall vessel diameter increased from 1.7 +/- 0.5 to 8.2 +/- 0.8 mm (P < 0.05). There were no procedure-related major adverse events. Immediate follow-up by multislice computed tomography scanning showed patency of the PV. At a median follow-up of 17.1 months (interquartile range 10.6-22.2 months), all patients have no or minimal persistent symptoms; multislice computed tomography showed patency of the PV followed at a median time of 16.4 months (interquartile range 10.3-22.3 months). CONCLUSIONS: The treatment of PV stenosis by angioplasty with stent implantation is feasible and safe. The majority of patients undergoing this procedure showed symptomatic improvement and patency of the PV.