The optimal management and short- and long-term prognoses of spontaneous coronary artery dissection (SCAD) remain not well defined. The aim of this observational multicenter study was to assess ...long-term clinical outcomes in patients with SCAD. In-hospital and long-term outcomes were assessed in 134 patients with documented SCAD, as well as the clinical impact and predictors of a conservative rather than a revascularization strategy of treatment. The mean age was 52 ± 11, years and 81% of patients were female. SCAD presented as an acute coronary syndromes in 93% of patients. A conservative strategy was performed in 58% of patients and revascularization in 42%. On multivariate analysis, distal versus proximal or mid location of dissection (odds ratio 9.27) and basal Thrombolysis In Myocardial Infarction (TIMI) flow grade 2 or 3 versus 0 or 1 (odds ratio 0.20) were independent predictors of conservative versus revascularization strategy. A conservative strategy was associated with better in-hospital outcomes compared with revascularization (rates of major adverse cardiac events 3.8% and 16.1%, respectively, p = 0.028); however, no significant differences were observed in the long-term outcomes. In conclusion, in this large observational study of patients with SCAD, angiographic features significantly influenced the treatment strategy, providing an excellent short- and long-term prognosis.
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.
Although transcatheter aortic valve implantation (TAVI) for severe aortic stenosis is becoming an established technique, the effect of gender-related differences is poorly described. We performed a ...gender-based comparison of high-risk patients undergoing TAVI with the self-expandable CoreValve Revalving System for severe aortic stenosis to evaluate early and mid-term clinical outcomes. From the Italian prospective CoreValve registry, 659 consecutive patients (55.8% women) who underwent TAVI were included in the present study. We analyzed the gender-based differences in terms of clinical, angiographic, and procedural features and the differences in the rate of early and mid-term major adverse cardiac and cerebrovascular events. The men were younger, presented more often with severe left ventricular dysfunction, and had a greater rate of previous myocardial infarction, coronary revascularization, peripheral artery disease, renal failure, and heart conduction disorders than the women. The logistic European System for Cardiac Operative Risk Evaluation score did not differ between the 2 groups. The overall unadjusted and adjusted analyses failed to show significant differences between genders in terms of major adverse cardiac and cerebrovascular events at a median follow-up of 13 months (range 8 to 18). At late follow-up (landmark analysis >12 months), a survival benefit was observed in women (hazard ratio 0.27, 95% confidence interval 0.09 to 0.84, p = 0.02). In conclusion, in this multicenter registry, the gender-based comparison of TAVI patients showed that men, despite the younger age, had more extensive atherosclerotic burden compared to women. Overall, the early and mid-term outcomes were similar between genders, although women might have a survival benefit with longer follow-up.
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.
Background The role of emergency reperfusion therapy in patients with ST-elevation myocardial infarction (STEMI) resuscitated after an out-of-hospital cardiac arrest (OHCA) has not been clearly ...established yet. The aim of this study was to evaluate the in-hospital and postdischarge outcomes of STEMI patients surviving OHCA and undergoing emergency angioplasty (percutaneous coronary intervention PCI) within an established regional network. Methods We prospectively collected data on 2,617 consecutive patients with STEMI treated with emergency PCI in 2005; in-hospital and 6-month outcomes of 99 patients who had experienced OHCA were compared with those of 2,518 patients without OHCA. The OHCA patients also underwent a cerebral performance evaluation after 12 months. Results OHCA patients were at higher clinical risk at presentation (cardiogenic shock 26% vs 5%, P < .0001). Percutaneous coronary intervention was successful in 80% of the OHCA and 89% of the non-OHCA patients ( P = NS). In-hospital mortality rates were 22% and 3%, respectively ( P < .0001). Independent predictors of in-hospital mortality among OHCA patients were longer delay between the call to the emergency medical system and the start of cardiopulmonary resuscitation (odds ratio OR 3.5, P = .03), nonshockable initial rhythms (OR 10.5, P = .002), cardiogenic shock (OR 3.05, P = .035), and a Glasgow Coma Scale score of 3 on admission (OR 2.9, P = .032). The 6-month composite rate of death, myocardial infarction, and revascularization among OHCA patients surviving the acute phase was comparable to that of non-OHCA patients (16% vs 13.9%, P = NS), and 87% of them showed a favorable neurologic recovery after 1 year. Conclusions Resuscitated OHCA patients undergoing emergency PCI for STEMI have worse clinical presentation and higher in-hospital mortality compared to those without OHCA. However, subsequent cardiac events are similar, and neurologic recovery is more favorable than reported in most previous series.
Transcatheter Valve-in-Valve Implantation Using CoreValve Revalving System for Failed Surgical Aortic Bioprostheses Francesco Bedogni, Maria Luisa Laudisa, Samuele Pizzocri, Corrado Tamburino, Gian ...Paolo Ussia, Anna Sonia Petronio, Massimo Napodano, Angelo Ramondo, Patrizia Presbitero, Federica Ettori, Gennaro Santoro, Silvio Klugman, Federico De Marco, Nedy Brambilla, Luca Testa CoreValve Revalving System (Medtronic, Minneapolis, Minnesota) implantation could be a valid option for patients with a failed aortic bioprosthesis deemed at prohibitive risk for surgical redo. In this multicenter consecutive cohort of 25 patients, the CoreValve Revalving System was feasible and effective regardless of the prevalent cause of failure (regurgitation or stenosis), with excellent procedural success and a considerable 6-month survival rate. These results can significantly affect the treatment of such a high-risk population.
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.
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