Abstract Objectives The 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). Background There is a paucity of evidence on long-term durability of currently available transcatheter heart valves. Methods Starting 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. Results All-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. Conclusions TAVI 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.
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.
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.
Abstract Objectives The aim of this study was to assess the incidence and clinical impact of balloon post-dilation (BPD) after transcatheter aortic valve replacement (TAVR) with the CoreValve ...prosthesis (Medtronic Inc., Minneapolis, Minnesota). Background BPD is a widely adopted strategy to reduce the degree of paraprosthetic regurgitation in case of transcatheter heart valve underexpansion. However, controversies still remain regarding its real effectiveness and safety. Methods The ClinicalService (a nation-based data repository and medical care project) dataset was analyzed. All patients were dichotomized according to the need for BPD during the index procedure. Results Among 1,376 patients, BPD of the transcatheter heart valve was performed in 272 (19.8%). In 37% of cases, it was unsuccessful at reducing the paravalvular regurgitation to mild or less. No case of valve embolization, new intravalvular regurgitation, coronary occlusion, and aortic root injury occurred during BPD. There were no statistically significant differences between the 2 groups in the incidence of in-hospital all-cause and cardiovascular mortality, neurological events, myocardial infarction, bleeding, conversion to open-chest surgery, and the need for a permanent pacemaker. The need for BPD did not emerge as an independent risk factor for all-cause (adjusted hazard ratio HR: 1.33, 95% confidence interval CI: 0.81 to 2.19, p = 0.264) and cardiovascular (adjusted HR: 1.48, 95% CI: 0.74 to 2.97, p = 0.265) mortality at 1 year after the procedure. In addition, BPD did not predispose to higher odds of neurological events during 12 months after TAVR (HR: 0.92, 95% CI: 0.45 to 1.88, p = 0.815). Conclusions This large study showed that BPD after TAVR was safe and not associated with increased rates of cerebrovascular events, mortality, myocardial infarction, and aortic root injury.
Although transcatheter aortic valve implantation (TAVI) is still currently guided by transesophageal echocardiography (TEE) in a considerable number of hospitals, exclusive angiographic (Angio) ...guidance seems a reasonable approach in this setting. To date, however, no studies have directly compared the outcomes of TAVI according to the imaging modality used for procedural guidance. We, therefore, used data from a large multicenter data repository to compare the outcomes of TAVI guided exclusively by Angio and ATEE. All consecutive patients with severe aortic stenosis who underwent TAVI with the CoreValve Revalving System (CRS) in 9 Italian centers from September 2007 to March 2014, dichotomized according to the imaging support used to guide the procedure (ATEE and Angio), were included. Thirty-day and 12-month clinical outcomes were evaluated. Propensity matching analysis was performed to adjust for baseline differences. A total of 625 patients were included (256 and 369 patients were included in the ATEE and Angio groups, respectively). Patients from the ATEE more frequently underwent TAVI under general anesthesia compared with Angio group (37.9% vs 22.8%, respectively, p <0.001). Importantly, ∼80% of the patients experienced mild or even less aortic regurgitation as assessed by angiography after the procedure, without between-group differences. Postdilation and valve-in-valve rates were equivalent (24.7% vs 25%, p = 0.934 and 5.5% vs 3.4%, respectively, p = 0.217). No differences were revealed in the rates of death, cardiovascular death, and stroke or transient ischemic attack at 12-month follow-up. These results were sustained after propensity matching analysis. In conclusion, as long as a comprehensive procedural planning is performed, TAVI with CRS may be performed exclusively under angiographic guidance without the need for associated TEE.
The aim of this study was to investigate the effects of transcatheter aortic valve implantation (TAVI) on left ventricular (LV) hypertrophy and diastolic function in patients with severe aortic valve ...stenosis (AVS). There are few and conflicting data on LV mass remodeling and LV diastolic function after TAVI.
Echocardiography and clinical assessment were performed at baseline and at 6 months in high-risk patients affected by severe AVS who underwent TAVI.
One hundred thirty-five patients successfully underwent TAVI. Peak transvalvular aortic pressure gradient and mean transvalvular aortic pressure gradient were reduced from 87 ± 25 to 18 ± 7 mm Hg and from 54 ± 14 to 9 ± 4 mm Hg, respectively (P < .001), accompanied by significant clinical improvement. The mean LV ejection fraction improved from 50 ± 13% to 54 ± 11% during follow-up (P = .009). At 6-month follow-up, interventricular septal wall thickness regressed from 14 ± 2 to 12 ± 1 mm and posterior wall thickness from 13 ± 3 to 11 ± 2 mm (P < .001). LV mass and LV mass index decreased from 332 ± 106 to 228 ± 58 g (P < .001) and from 191 ± 58 to 132 ± 30 g/m(2) (P < .001), respectively. Ninety-seven patients (72%) showed improvements in LV diastolic filling pattern. The mean e' value increased from 4.1 ± 1.7 to 5.6 ± 2.2 cm/sec, and the mean E/e' ratio decreased from 24 ± 7 to 17 ± 6 (P < .001) after TAVI.
Significant LV mass reverse remodeling associated with improvement in LV systolic and diastolic function was found in patients with severe AVS 6 months after TAVI. These changes may have relevant clinical prognostic value.
Degeneration of a surgically implanted valve bioprosthesis may occur in elderly, frail patients with an extremely high risk to undergo redo cardiac surgery. Transapical or fully percutaneous ...transseptal approaches have been described in order to treat degenerated aortic and mitral bioprosthesis. We performed the first-in-man successful mitral transcatheter valve delivery with a valve-in-valve technique through an innovative route; ie, a video-assisted endoscopic direct access to the left atrium, in an 82-year-old patient who previously underwent surgical replacement of the mitral valve and with a prohibitive surgical risk.
Abstract Objectives The aim of this study was to investigate whether the 2 tirofiban formulations tested in the early and late phases of the PRISM (Platelet Receptor Inhibitor in Ischemic Syndrome ...Management) trial might differ with respect to risk for thrombocytopenia and clinical outcomes compared with unfractionated heparin (UFH). Background Citrate-buffered tirofiban is currently marketed as brand-name drug. However, tirofiban has recently been promoted in some countries as a generic drug with different formulations, such as phosphate-buffered product. Methods In the PRISM trial 3,232 patients were randomly assigned to receive tirofiban or UFH. In the early phase, 879 patients were allocated to phosphate-buffered tirofiban and 874 patients to UFH group. After a protocol amendment due to a study drug instability report, citrate-buffered tirofiban replaced the phosphate-buffered formulation. Therefore, in the late phase, 737 and 742 patients were treated with citrate-buffered tirofiban and UFH, respectively. Results The relative risk for thrombocytopenia (nadir <90,000/mm3 or <100,000/mm3 ) was increased in patients treated with phosphate-buffered tirofiban in the early phase (odds ratio OR: 3.51; 95% confidence interval CI: 1.15 to 10.73; p = 0.027; and OR: 2.83; 95% CI: 1.11 to 7.22; p = 0.029, respectively) but not in patients treated with citrate-buffered tirofiban in the late phase (OR: 1.01; 95% CI: 0.20 to 5.05; p = 0.987; and OR: 0.99; 95% CI: 0.26 to 3.45; p = 0.991, respectively). Using a combined definition of thrombocytopenia (nadir <150,000/mm3 or a decrease ≥50%), the randomization period significantly modified the effect of the treatment (tirofiban vs. UFH) on platelet decrease (p for interaction = 0.024). Thrombocytopenia was associated with a 5- to 10-fold increased risk for TIMI (Thrombolysis In Myocardial Infarction) bleeding and a 2-fold increased risk for net adverse cardiovascular events. Conclusions Phosphate-buffered tirofiban, currently marketed as a generic drug, is associated with a higher rate of thrombocytopenia with a potentially increased risk for adverse clinical outcomes compared with citrate-buffered tirofiban.
Emergency surgery for acute vein graft perforation and balloon entrapment during percutaneous angioplasty is reported here. Prompt extracorporeal circulation through peripheral cannulation enabled ...the control of systemic perfusion despite cardiac arrest. Vein graft repair was achieved by an autologous pericardial patch. Appropriate and tailored mechanical circulatory support allowed successful extracorporeal circulation withdrawal, limited intraoperative cardiac damage, and postoperative controlled recovery of ventricular function with ultimate favorable outcome.
Background Transradial intervention (TRI) and bivalirudin infusion compared with transfemoral coronary intervention or unfractionated heparin plus glycoprotein IIb/IIIa inhibitors decrease bleeding ...complications in patients with acute coronary syndromes (ACS). Although bleeding is thought to be associated with worse outcomes, it remains unclear whether TRI and bivalirudin both independently lower ischemic or combined ischemic and bleeding complications in ACS patients undergoing contemporary invasive management. Hypotheses The primary objectives of the MATRIX program are to assess whether TRI or bivalirudin as compared, respectively, with transfemoral coronary intervention (MATRIX access site) or unfractionated heparin plus provisional glycoprotein IIb/IIIa inhibitors, (MATRIX antithrombin) decrease the 30-day incidence of an ischemic (ie, death, myocardial infarction or stroke) or an ischemic and bleeding composite end point across the whole spectrum of ACS patients, including clarifying the optimal duration of bivalirudin infusion after percutaneous coronary intervention (MATRIX treatment duration). Study design The MATRIX (NCT01433627) study, which incorporates 3 randomized comparisons in a nonfactorial manner and primary end points at 30 days and clinical follow-up ≤1 year, is a large-scale, multicenter study with blind event adjudication conducted at approximately 100 European sites. With 8,200 patients in the randomized comparison of access sites and 6,800 individuals participating in the randomized comparison of antithrombin regimens, this study will have ≥85% power for the primary end points. Summary The MATRIX program aims at conclusively ascertaining the role of TRI and bivalirudin infusion in the whole spectrum of ACS patients undergoing contemporary invasive management.
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