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1.
Ann Thorac Surg ; 2019 Nov 02.
Artigo em Inglês | MEDLINE | ID: mdl-31689408

RESUMO

This report describes an unreported complication after stent-grafting of the aortic arch for residual dissection following ascending aorta and aortic arch replacement for acute type A dissection. The patient developed, one year later, a pseudoaneurysm originating from the proximal suture line and therefore far from the stent-graft landing zone, that fistulized into the pulmonary artery. Possible causes are: suture damage during stent deployment or change of system forces after stent placement leading to high-tension on the suture line. Emergency surgery was performed. Aortic arch stent grafting is a new promising technique but its complications are still not completely known.

2.
J Am Coll Cardiol ; 2019 Sep 20.
Artigo em Inglês | MEDLINE | ID: mdl-31562908

RESUMO

BACKGROUND: Transfemoral aortic valve replacement (TAVR) is a guideline-recommended treatment option for patients with severe aortic valve stenosis. Females and males present with different baseline characteristics, which may influence procedural outcomes. OBJECTIVES: To evaluate differences between females and males undergoing transfemoral TAVR across the globe during the last decade. METHODS: The CENTER collaboration was a global patient level dataset of patients undergoing transfemoral TAVR (N= 12,381) from 2007-2018. In this retrospective analysis we examined differences in baseline patient characteristics, 30-day stroke and mortality and in-hospital outcomes between female and male patients. We also assessed for temporal changes in outcomes and predictors for mortality per gender. RESULTS: We included 58% (n=7,120) female and 42% (n=5,261) male patients. Females had higher prevalence of hypertension and glomerular filtration rate <30ml/min/m2, but lower prevalence of all other traditional cardiovascular comorbidities. Both genders had similar rates of 30-day stroke (2.3% vs 2.5%, p=0.53) and mortality (5.9% vs. 5.5%, p=0.17). In contrast, females had a 50% higher risk of life-threatening or major bleeding (6.7% vs 4.4%, p<0.01). Over the study period mortality rates decreased to a greater extent in males than in females (60% vs 50% reduction, both p<0.001), with no reductions in stroke rates over time. CONCLUSIONS: In this global collaboration females and males had similar rates of 30-day mortality and stroke. However, females had higher rates of procedural life-threatening or major bleeding after TAVR. Between 2007 and 2018 mortality rates decreased to a greater extent in males than in females.

3.
Artigo em Inglês | MEDLINE | ID: mdl-31213376

RESUMO

OBJECTIVES: The aim of this retrospective multicenter study was to compare early clinical and hemodynamic outcomes of Perceval-S sutureless (Livanova, London, United Kingdom) and Intuity rapid-deployment (Edwards Lifesciences, Irvine, Calif) bioprostheses. METHODS: Data from patients who underwent isolated or combined aortic valve replacement with Perceval-S and with Intuity bioprostheses at 18 cardiac surgical institutions were analyzed. Propensity matching was performed to identify similar patient cohorts. RESULTS: We included 911 patients from March 2011 until May 2017. Perceval-S and Intuity valves were implanted in 349 (38.3%) and in 562 (61.7%) patients, respectively. Propensity score identified 117 matched pairs. In the matched cohort, device success was 99.1% and 100% in Perceval-S and Intuity group, respectively (P = 1.000). Thirty-day Valve Academic Research Consortium mortality occurred in 2 (1.7%) and 4 (3.4%) patients in the Perceval-S and in Intuity group, respectively (P = .6834). The rate of postoperative new permanent pacemaker implantation was 6% (7 patients) and 6.8% (8 patients) in the Perceval-S and in Intuity group, respectively (P = .7896). Perceval-S valve implantation requires significantly shorter aortic crossclamp and cardiopulmonary bypass times than Intuity valve implantation (aortic crossclamp time for isolated, 52 ± 14 minutes vs 62 ± 24 minutes; P < .0001). Peak transaortic gradients were 22.4 ± 8.1 mm Hg and 19.6 ± 6.7 mm Hg (P = .0144), whereas mean gradients were 11.8 ± 4.7 mm Hg and 10.5 ± 3.9 mm Hg (P = .0388) in the Perceval-S and Intuity groups, respectively. CONCLUSIONS: Sutureless Perceval-S and rapid-deployment Intuity bioprostheses provide good and similar early clinical and hemodynamic outcomes. Perceval-S valve implantation requires shorter crossclamp and cardiopulmonary bypass times, whereas Intuity valve implantation provides lower transaortic peak and mean gradients.

4.
JACC Cardiovasc Interv ; 12(10): 911-920, 2019 May 27.
Artigo em Inglês | MEDLINE | ID: mdl-31122347

RESUMO

OBJECTIVES: This study aimed to compare differences in patient characteristics and clinical outcomes of nonagenarians undergoing transcatheter aortic valve replacement (TAVR) versus patients younger than 90 years of age and to test the predictive accuracy of the logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation), the EuroSCORE II, and the STS-PROM (Society of Thoracic Surgeons Predicted Risk of Mortality) for mortality after TAVR in nonagenarians. BACKGROUND: The prevalence of severe aortic valve stenosis is increasing due to the rising life expectancy. However, there are limited data evaluating outcomes in patients older than 90 years of age. Moreover, the predictive accuracy of risk scores for mortality has not been evaluated in nonagenarian patients undergoing transfemoral TAVR. METHODS: The CENTER (Cerebrovascular EveNts in Patients Undergoing TranscathetER Aortic Valve Implantation) collaboration (N = 12,381) is an international collaboration consisting of 3 national registries, 6 local or multicenter registries, and 1 prospective clinical study, selected through a systematic online search. The primary endpoint of this study was the difference in 30-day all-cause mortality and stroke after TAVR in nonagenarians versus patients younger than 90 years of age. Secondary endpoints included differences in baseline characteristics, in-hospital outcomes, and the differences in predictive accuracy of the logistic EuroSCORE, the EuroSCORE II, and STS-PROM. RESULTS: A total of 882 nonagenarians and 11,499 patients younger than 90 years of age undergoing transfemoral TAVR between 2007 and 2018 were included. Nonagenarians had considerably fewer comorbidities than their counterparts. Nevertheless, rates of 30-day mortality (9.9% vs. 5.4%; relative risk [RR]: 1.8; 95% confidence interval [CI]: 1.4 to 2.3; p = 0.001), in-hospital stroke (3.0% vs. 1.9%; RR: 1.5; 95% CI: 1.0 to 2.3; p = 0.04), major or life-threatening bleeding (8.1% vs. 5.5%; RR: 1.6; 95% CI: 1.1 to 2.2; p = 0.004), and new-onset atrial fibrillation (7.9% vs. 5.2%; RR: 1.6; 95% CI: 1.1 to 2.2; p = 0.01) were higher in nonagenarians. The STS-PROM adequately estimated mortality in nonagenarians, with an observed-expected mortality ratio of 1.0. CONCLUSIONS: In this large, global, patient-level analysis, mortality after transfemoral TAVR was 2-fold higher in nonagenarians compared with patients younger than 90 years of age, despite the lower prevalence of baseline comorbidities. Moreover, nonagenarians had a higher risk of in-hospital stroke, major or life-threatening bleeding, and new-onset atrial fibrillation. The STS-PROM was the only surgical risk score that accurately predicted the risk of mortality in nonagenarians.

5.
Circ Cardiovasc Interv ; 12(3): e007546, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-30871358

RESUMO

BACKGROUND: Stroke remains one of the most devastating complications of transcatheter aortic valve implantation (TAVI). The aim of this study was to identify the incidence, timing, temporal trends, and predictors of stroke after TAVI and evaluate the outcomes of patients with stroke. METHODS AND RESULTS: The CENTER-Collaboration is an international collaboration consisting of 3 national registries and 7 local registries or prospective clinical trials, selected through a systematic review. Accordingly, a total of 10 982 patients undergoing transfemoral TAVI between 2007 and 2018 were included in the current patient-level pooled analyses. A total of 261 patients (2.4%) experienced stroke during the first month after TAVI. The median time between TAVI and stroke was 1 day (interquartile range, 0-6 days). The stroke rate was comparable in procedures performed in the early years of TAVI (2007-2012) to those in the more recent years of TAVI (2013-2018; both 2.4%; P=1.0). Independent predictors of stroke at 30 days were a history of cerebrovascular events (odds ratio, 2.2; 95% CI, 1.4-3.6; P=0.0012) and a glomerular filtration rate of <30 mL/min per 1.73 m2 (odds ratio, 1.7; 95% CI, 1.0-2.8; P=0.05). Stroke occurring within the first 30 days after TAVI was associated with a 6-fold increase of 30-day mortality (odds ratio, 6.0; 95% CI, 4.4-8.1; P<0.001). Moreover, patients with stroke more frequently had documented new-onset atrial fibrillation (16% versus 3%; P<0.001) and major or life-threatening bleedings (12% versus 7%; P=0.002) at 30-day follow-up. CONCLUSIONS: In this large, global, patient-level analysis, the incidence of stroke after transfemoral TAVI was 2.4%. Prior cerebrovascular events and a low glomerular filtration rate independently predicted the occurrence of stroke after TAVI. The occurrence of stroke after TAVI was associated with a strikingly 6-fold increase of 30-day mortality; additionally, there was a 5-fold higher rate of new-onset atrial fibrillation in patients with stroke. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT03588247.

6.
Eur Heart J ; 40(5): 456-465, 2019 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-30590565

RESUMO

Aims: The aim of this study was to compare clinical outcomes of patients undergoing transfemoral transcatheter aortic valve implantation (TAVI) with balloon-expandable (BE) valves vs. self-expandable (SE) valves. Transcatheter aortic valve implantation is a minimally invasive and lifesaving treatment in patients with aortic valve stenosis. Even though BE-valves and SE-valves are both commonly used on a large scale, adequately sized trials comparing clinical outcomes in patients with severe aortic valve stenosis treated with BE-valves compared with SE-valves are lacking. Methods and results: In this CENTER-collaboration, data from 10 registries or clinical trials, selected through a systematic search, were pooled and analysed. Propensity score methodology was used to reduce treatment selection bias and potential confounding. The primary endpoints were mortality and stroke at 30 days follow-up in patients treated with BE-valves compared with SE-valves. Secondary endpoints included clinical outcomes, e.g. bleeding during hospital admission. All outcomes were split for early-generation BE-valves compared with early-generation SE-valves and new-generation BE-valves with new-generation SE-valves. The overall patient population (N = 12 381) included 6239 patients undergoing TAVI with BE-valves and 6142 patients with SE-valves. The propensity matched population had a mean age of 81 ± 7 years and a median STS-PROM score or 6.5% [interquartile range (IQR) 4.0-13.0%]. At 30-day follow-up, the mortality rate was not statistically different in patients undergoing TAVI with BE-valves compared with SE-valves [BE: 5.3% vs. SE: 6.2%, relative risk (RR) 0.9; 95% confidence interval (CI) 0.7-1.0, P = 0.10]. Stroke occurred less frequently in patients treated with BE-valves (BE: 1.9% vs. SE: 2.6%, RR 0.7; 95% CI 0.5-1.0, P = 0.03). Also, patients treated with BE-valves had a three-fold lower risk of requiring pacemaker implantation (BE: 7.8% vs. SE: 20.3%, RR 0.4; 95% CI 0.3-0.4, P < 0.001). In contrast, patients treated with new-generation BE-valves more frequently experienced major and life-threatening bleedings compared with new-generation SE-valves (BE: 4.8% vs. SE: 2.1%, RR 2.3; 95% CI 1.6-3.3, P < 0.001). Conclusion: In this study, which is the largest study to compare valve types in TAVI, we demonstrated that the incidence of stroke and pacemaker implantation was lower in patients undergoing transfemoral TAVI with BE-valves compared with SE-valves. In contrast, patients treated with new-generation BE-valves more often suffered from major or life-threatening bleedings than patients with new-generation SE-valves. Mortality at 30-days was not statistically different in patients treated with BE-valves compared with SE-valves. This study was a propensity-matched analysis generated from observational data, accordingly current outcomes will have to be confirmed in a large scale randomized controlled trial.

7.
J Cardiovasc Med (Hagerstown) ; 19(11): 655-663, 2018 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-30299408

RESUMO

BACKGROUND: New-generation transcatheter heart valves have been developed to reduce complications of transcatheter aortic valve implantation (TAVI). With this study we sought to compare procedural and 30-day outcomes of the new-generation repositionable Boston Scientific Lotus (Lotus) and the balloon-expandable Edwards Sapien 3 (ES3) transcatheter heart valves. METHODS: A total of 315 patients with severe symptomatic aortic stenosis undergoing transfemoral TAVI with Lotus or ES3 included in two large Italian registries were considered for this analysis. After propensity matching, 93 matched pairs of patients were included. Outcomes were evaluated according to Valve Academic Research Consortium-2 definition at discharge and 30 days. RESULTS: There were no differences in baseline characteristics, except for lower mean aortic gradient and larger mean aortic annulus in the ES3-treated patients. Valve Academic Research Consortium-2 defined device success was high and comparable between groups (97.8 for Lotus vs. 98.9% for ES3, P = 0.09). The frequency of moderate/severe paravalvular leak was low and similar for both devices (2.2 vs. 1.1%, P = 0.10). At 30 days, both groups showed low all-cause mortality (5.4 vs. 1.1%, P = 0.10) and rates of disabling stroke (3.2 vs. 1.1%, P = 0.31). New pacemaker implantation was more common after Lotus deployment (31.7 vs. 10.5%, P < 0.001). CONCLUSION: Transfemoral TAVI with both Lotus and ES3 resulted in favorable clinical and hemodynamic procedural and 30-day outcomes. Rates of significant paravalvular leak were low with both devices. The Lotus valve was associated with higher risk of pacemaker implantation.

8.
J Cardiovasc Med (Hagerstown) ; 19(12): 748-755, 2018 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-30300243

RESUMO

AIMS: A global outbreak of Mycobacterium chimaera infections following cardiac surgery and linked to contaminated heater-cooler units (HCUs) is currently ongoing. Neither the status of this outbreak in Italy nor the mitigation strategies adopted by adult cardiac surgery units (ACSUs) are currently known. In 2017, the Italian Society of Cardiac Surgery launched a national survey among the Italian ACSU to shed some light on this issue. METHODS: In Italy, there are 90 ACSUs across 20 regions. From May to November 2017, these ACSUs were surveyed collecting data on patients diagnosed with MC infections, ACSU workload, HCU models in use and control measures adopted in the operatory room. RESULTS: The response rate was 87.8%. The median number of cardiac procedures at each ACSU was 450/year [interquartile range (IQR) 350-650 procedures/year], and nationally, the number of procedures/year exceeded 40k. In Italy, seven patients with M. chimaera infections following cardiac procedures have been reported since 2015: all had aortic or valvular surgery as the first procedure; the median latency between the first operation and the infection was 2 years (IQR 2-3.25). Mortality for patients requiring redo cardiac surgery was 50%. M. chimaera infections risk was 0.4-1 patient every 1000 cardiac procedures. The most common HCU model in Italy is the 3T HCU (70.9%). The most common control measures adopted included implementing new HCU disinfection protocols, using sterile or filtrated water in the HCU and displacing HCU fans away from the patient: HCU replacement and microbiology testing were instead infrequent. CONCLUSION: In Italy, the risk of contracting M. chimaera infections and the mortality reported are in line with other European countries, but significant heterogeneity exists on the mitigation strategies adopted to prevent further M. chimaera inoculations, suggesting the development of national guidelines.

9.
Ann Thorac Surg ; 106(6): 1742-1749, 2018 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-30055145

RESUMO

BACKGROUND: Rapid deployment bioprostheses (RDBs) have been recently introduced into clinical practice for the treatment of severe aortic valve stenosis. The aim of this retrospective multicenter study was to assess early and mid-term clinical and hemodynamic outcomes of patients undergoing RDB implantation. METHODS: Data from a national registry that included patients who underwent isolated or combined aortic valve replacement with RDB in Italy were analyzed. Definitions of the European System for Cardiac Operative Risk Evaluation were used for preoperative variables and updated definitions from the Valve Academic Research Consortium were used for postoperative outcomes assessment. Univariable and multivariable analyses were performed to identify independent predictors of mortality. Follow-up was performed with clinical and echocardiographic examinations at each study site and, if this was not possible, through telephonic interviews. The Kaplan-Meier method was used for survival analysis. RESULTS: A total of 902 patients (December 2012 through November 2017) from 20 national centers were included in the registry. Device success was 95.9%, and 30-day all-cause mortality was 2.8%. Postoperative pacemaker implantation was needed in 63 patients (6.9%). At discharge, peak and mean transaortic gradients were 19 ± 7 mm Hg and 11 ± 4 mm Hg, respectively. Mild and moderate aortic regurgitation were found in 71 patients (8.2%) and in 10 patients (1.2%), respectively. Median follow-up time was 357 days (interquartile range: 103 to 638 days). Survival at 4 years was 86% ± 1%. Preoperative conduction disturbances and history of previous myocardial infarction were independently associated with mortality. CONCLUSIONS: Aortic RDBs provide good early and mid-term clinical and hemodynamic outcomes. These devices may be considered as a reasonable alternative to conventional bioprostheses, especially in minimally invasive and combined operations.

10.
J Am Coll Cardiol ; 71(1): 25-36, 2018 Jan 02.
Artigo em Inglês | MEDLINE | ID: mdl-29102688

RESUMO

BACKGROUND: Conventional mitral valve (MV) operations allow direct anatomic assessment and repair on an arrested heart, but require cardiopulmonary bypass, aortic cross-clamping, sternotomy or thoracotomy, and cardioplegic cardiac arrest, and are associated with significant perioperative disability, and risks of morbidity and mortality. OBJECTIVES: This study evaluated safety and performance of a transesophageal echocardiographic-guided device designed to implant artificial expanded polytetrafluoroethylene (ePTFE) cords on mitral leaflets in the beating heart. METHODS: In a prospective multicenter study, 30 consecutive patients with severe degenerative mitral regurgitation (MR) were treated with a mitral valve repair system (MVRS) via small left thoracotomy. The primary (30-day) endpoint was successful implantation of cords with MR reduction to moderate or less. RESULTS: The primary endpoint was met in 27 of 30 patients (90%). Three patients required conversion to open mitral surgery. There were no deaths, strokes, or permanent pacemaker implantations. At 1 month, MR was mild or less in 89% (24 of 27) and was moderate in 11% (3 of 27). At 6 months, MR was mild or less in 85 % (22 of 26), moderate in 8% (2 of 26), and severe in 8% (2 of 26). Favorable cardiac remodeling at 6 months included decreases in end-diastolic (161 ± 36 ml to 122 ± 30 ml; p < 0.001) and left atrial volumes (106 ± 36 ml to 69 ± 24 ml; p < 0.001). The anterior-posterior mitral annular dimension decreased from 34.7 ± 5.8 mm to 28.2 ± 5.1 mm; p < 0.001 as did the mitral annular area (10.0 ± 2.7 cm2 vs. 6.9 ± 2.0 cm2; p < 0.0001). CONCLUSIONS: MVRS ePTFE cordal implantation can reduce the invasiveness and morbidity of conventional MV surgery. The device's safety profile is promising and prospective trials comparing the outcomes of the MVRS to conventional MV repair surgery are warranted. (CE Mark Study for the Harpoon Medical Device [TRACER]; NCT02768870).

11.
Eur Heart J ; 39(8): 676-684, 2018 Feb 21.
Artigo em Inglês | MEDLINE | ID: mdl-29253177

RESUMO

Aims: Life-threatening complications occur during transcatheter aortic valve implantation (TAVI) which can require emergent cardiac surgery (ECS). Risks and outcomes of patients needing ECS during or immediately after TAVI are still unclear. Methods and results: Incidence, risk factors, management, and outcomes of patients requiring ECS during transfemoral (TF)-TAVI were analysed from a contemporary real-world multicentre registry. Between 2013 and 2016, 27 760 patients underwent TF-TAVI in 79 centres. Of these, 212 (0.76%) patients required ECS (age 82.4 ± 6.3 years, 67.5% females, logistic EuroSCORE: 17.1%, STS-score 5.8%). The risk of ECS declined from 2013 (1.07%) to 2014 (0.70%) but remained stable since. Annual TF-TAVI numbers have more than doubled from 2013 to 2016. Leading causes for ECS were left ventricular perforation by the guidewire (28.3%) and annular rupture (21.2%). Immediate procedural mortality (<72 h) of TF-TAVI patients requiring ECS was 34.6%. Overall in-hospital mortality was 46.0%, and highest in case of annular rupture (62%). Independent predictors of in-hospital mortality following ECS were age > 85 years [odds ratio (OR) 1.87, 95% confidence interval (95% CI) (1.02-3.45), P = 0.044], annular rupture [OR 1.96, 95% CI (0.94-4.10), P = 0.060], and immediate ECS [OR 3.12, 95% CI (1.07-9.11), P = 0.037]. One year of survival of the 114 patients surviving the in-hospital period was only 40.4%. Conclusion: Between 2014 and 2016, the need for ECS remained stable around 0.7%. Left ventricular guidewire perforation and annular rupture were the most frequent causes, accounting for almost half of ECS cases. Half of the patients could be salvaged by ECS-nevertheless, 1 year of all-cause mortality was high even in those ECS patients surviving the in-hospital period.

12.
Eur J Cardiothorac Surg ; 53(4): 871-873, 2018 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-29092010

RESUMO

Transapical off-pump echo-guided mitral valve repair with implantation of artificial ePTFE chordae with the Harpoon device has been proposed to treat patients presenting with severe mitral regurgitation due to posterior leaflet prolapse. The device is inserted in the left ventricle and steered to the surface of the diseased portion of the leaflet. The Harpoon device is actuated, and the leaflet is perforated by a needle that consequently releases an ePTFE chord that is fixed on the atrial surface by a double-helix coiled knot. The chord is then tensioned and fixed on the epicardial surface of the ventricle under echocardiography guidance.

13.
Ann Cardiothorac Surg ; 6(5): 473-483, 2017 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-29062742

RESUMO

BACKGROUND: Data on transcatheter aortic valve replacement (TAVR) long-term clinical outcomes and hemodynamic performance of the self-expandable CoreValve (CV) and the balloon-expandable Edwards SAPIEN XT (ES) (Edwards Lifesciences, Irvine, California, USA) transcatheter heart valves (THV) are limited. Therefore, this study aimed to compare long-term clinical outcome data and hemodynamic performance of TAVR with either CV or ES. METHODS: We reviewed prospectively collected data of 171 patients treated with TAVR for severe aortic stenosis (AS) at our center between June 2007 and December 2010, with last follow-up contact in 2016. RESULTS: Out of 171 patients treated with TAVR at our Institution, 87 received a CV and 84 an ES THV. Mean age was 81 [78-85] years, and mean Society of Thoracic Surgeons (STS) score was 7.5% (4.5-13.9%). Hemodynamic success by Valve Academic Research Consortium (VARC) definition was 97.1%. Mean trans-prosthetic gradient remained low and stable during follow-up in both groups (at 5-year 9.2±6.4 versus 12.7±5.1 mmHg, P=0.10). Late prosthesis failure occurred in 4 cases (2.4%). Thirty-day mortality was 4.7%, and estimated survival rates by Kaplan-Meyer after 1, 5 and 8 years were 87.6%, 44.9%, and 24.5%, respectively, without difference between THV groups. Rates of cardiovascular death, stroke, myocardial infarction (MI) and congestive heart failure (CHF) were also similar with CV and ES at long-term follow-up. History of CHF, pre-existent severe mitral regurgitation, paravalvular leak grade ≥2+, and chronic obstructive pulmonary disease were independent predictors of late mortality at multivariable analysis. CONCLUSIONS: Clinical and hemodynamic outcomes of patients treated by self-expandable CV or balloon-expandable ES THV were favorable and similar throughout long-term follow-up, with a rate of prosthesis failure of less than 3%.

14.
Ann Cardiothorac Surg ; 6(5): 510-515, 2017 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-29062747

RESUMO

Current surgical treatment options for aortic valve stenosis (AS), as alternatives to that of conventional operation with a midline sternotomy, include sutureless valve replacement (SUAVR) and transcatheter valve implantation (TAVI). Patients with high surgical risk, or those who are judged to be inoperable, are typically good candidates for the TAVI procedure. The best treatment option in patients with an intermediate risk profile, however, the so called "grey zone", is still currently under debate. Sutureless aortic valve replacement has been recently presented as a valid alternative for patients with low- to intermediate-risk. Data available on prostheses' hemodynamic performance and patients' clinical outcomes play a crucial role in the process of device selection. Compared to TAVI, SUAVR provides lower rate of significant postoperative paravalvular leak (PVL), which has shown to be a predictor for mortality. On the contrary, transcatheter valves seem to perform better in terms of transvalvular mean and peak gradients. Therefore, SUAVR and TAVI are both reliable options in patients with severe aortic valve stenosis, as an alternative to conventional surgery, and the choice of the best device should be tailored to patient's anatomical and surgical characteristics.

15.
Eur J Cardiothorac Surg ; 52(5): 874-880, 2017 Nov 01.
Artigo em Inglês | MEDLINE | ID: mdl-28977359

RESUMO

OBJECTIVES: The most commonly used accesses for transcatheter aortic valve implantation (TAVI) are the transfemoral (TF-TAVI) and the transapical (TA-TAVI) ones. There are concerns about TA-TAVI use in patients with reduced left ventricular ejection fraction (LVEF). The aim of this retrospective multicentre study was to compare the outcomes of TA-TAVI and TF-TAVI in patients with poor LVEF. METHODS: Patients with LVEF ≤35% were included in the analysis. Data were obtained from the Italian Transcatheter Balloon-Expandable Registry (ITER), which enrolled patients undergoing TAVI with the Sapien bioprosthesis in 33 national centres. Patients were divided into 2 groups according to the access: TA or TF. A multivariable logistic regression analysis was performed in order to evaluate whether the type of approach (TA and TF) has an impact on outcomes. RESULTS: Between 2007 and 2012, 1882 patients were enrolled in the Registry. LVEF ≤35% was found in 208 (11.1%) patients. TA-TAVI and TF-TAVI were performed in 69 (33.2%) and 139 (66.8%) patients, respectively. Overall 30-day mortality was 11.6% and 7.9% in TA and TF patients, respectively (P = 0.45). Overall Kaplan-Meier survival was significantly higher in the TF-TAVI group (log rank: P = 0.003). Age [odds ratio (OR) 1.066, P = 0.016], creatinine (OR: 2.301, P < 0.001), preoperative permanent pacemaker (OR: 4.662, P = 0.035) and TA approach (OR: 2.577, P = 0.006) were identified as independent predictors of overall mortality at follow-up. However, the TA approach resulted an independent variable of mortality only 3 years after TAVI. CONCLUSIONS: TAVI yields good results in patients with depressed LVEF. Age, preoperative creatinine and preoperative pacemaker are independently associated with mortality. The TA access is associated with mortality only after 3 years of follow-up, thus probably reflecting a worse general clinical status of these patients.


Assuntos
Valva Aórtica/cirurgia , Volume Sistólico/fisiologia , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/estatística & dados numéricos , Disfunção Ventricular Esquerda/fisiopatologia , Ecocardiografia , Humanos , Itália/epidemiologia , Estimativa de Kaplan-Meier , Sistema de Registros , Estudos Retrospectivos
17.
EuroIntervention ; 13(12): e1392-e1400, 2017 12 08.
Artigo em Inglês | MEDLINE | ID: mdl-28870875

RESUMO

AIMS: The safety and efficacy of single vs. dual antiplatelet therapy (DAPT) in patients undergoing TAVI remain to be addressed. The aim of our study was to evaluate the usefulness of a DAPT compared to a single platelet therapy in patients undergoing TAVI with a balloon-expandable prosthesis. METHODS AND RESULTS: All consecutive patients enrolled in the ITER registry were included. Patients undergoing TAVI discharged with aspirin alone were compared to those taking DAPT before and after selection using propensity score with matching. Subgroup analysis was performed for those on OAT. Prosthetic heart valve dysfunction at follow-up was the primary endpoint, whereas all-cause death, cardiovascular death, bleedings, vascular complications and cerebrovascular accidents were the secondary ones. From 1,364 patients, after propensity score with matching, 605 were selected for each group (aspirin alone vs. DAPT). At 30 days, rates of VARC mortality were lower in patients with aspirin alone (1.5% vs. 4.1%, p=0.003), mainly driven by a reduction of major vascular complications (5.3% vs. 10.7%, p<0.001) and of major bleedings (6.6% vs. 11.5%, p<0.001), without a difference in prosthetic heart valve dysfunction after 45±14 months (2.8% vs. 3.0%, p=0.50). These results were confirmed on multivariable analysis. CONCLUSIONS: After TAVI with a balloon-expandable prosthesis, aspirin alone does not increase the risk of prosthetic valve dysfunction, and reduces the risk of periprocedural complications and of 30-day all-cause death.


Assuntos
Hemorragia/induzido quimicamente , Inibidores da Agregação de Plaquetas/efeitos adversos , Sistema de Registros , Acidente Vascular Cerebral/prevenção & controle , Substituição da Valva Aórtica Transcateter/efeitos adversos , Idoso , Idoso de 80 Anos ou mais , Aspirina/efeitos adversos , Clopidogrel , Estudos de Coortes , Feminino , Humanos , Masculino , Pontuação de Propensão , Acidente Vascular Cerebral/etiologia , Ticlopidina/efeitos adversos , Ticlopidina/análogos & derivados
19.
Eur J Cardiothorac Surg ; 52(4): 768-774, 2017 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-28575189

RESUMO

OBJECTIVES: Prosthetic valve endocarditis (PVE) is an uncommon yet dreadful complication in patients with prosthetic valves that requires a distinct analysis from native valve endocarditis. The present study aims to investigate independent risk factors for early surgical outcomes in patients with PVE. METHODS: A retrospective cohort study was conducted in 8 Italian Cardiac Surgery Units from January 2000 to December 2013 by enrolling all PVE patients undergoing surgical treatment. RESULTS: A total of 209 consecutive patients were included in the study. During the study period, the global rate of surgical procedures for PVE among all operations for isolated or associated valvular disease was 0.45%. Despite its rarity this percentage increased significantly during the second time frame (2007-2013) in comparison with the previous one (2000-2006): 0.58% vs 0.31% (P < 0.001). Intraoperative and in-hospital mortality rates were 4.3% and 21.5%, respectively. Logistic regression analysis identified the following factors associated with in-hospital mortality: female gender [odds ratio (OR) = 4.62; P < 0.001], shock status (OR = 3.29; P = 0.02), previous surgical procedures within 3 months from the treatment (OR = 3.57; P = 0.009), multivalvular involvement (OR = 8.04; P = 0.003), abscess (OR = 2.48; P = 0.03) and urgent surgery (OR = 6.63; P < 0.001). CONCLUSIONS: Despite its rarity, PVE showed a significant increase over time. Up to now, in-hospital mortality after surgical treatment still remains high (>20%). Critical clinical presentation and extension of anatomical lesions are strong preoperative predictors for poor early outcome.


Assuntos
Doenças das Valvas Cardíacas/cirurgia , Implante de Prótese de Valva Cardíaca/efeitos adversos , Próteses Valvulares Cardíacas , Mortalidade Hospitalar , Infecções Relacionadas à Prótese/cirurgia , Adulto , Idoso , Estudos de Coortes , Feminino , Seguimentos , Doenças das Valvas Cardíacas/diagnóstico por imagem , Doenças das Valvas Cardíacas/mortalidade , Implante de Prótese de Valva Cardíaca/métodos , Humanos , Itália , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Valor Preditivo dos Testes , Infecções Relacionadas à Prótese/microbiologia , Infecções Relacionadas à Prótese/mortalidade , Reoperação/métodos , Estudos Retrospectivos , Medição de Risco , Infecções Estafilocócicas/diagnóstico , Infecções Estafilocócicas/epidemiologia , Taxa de Sobrevida , Fatores de Tempo , Resultado do Tratamento
20.
Am J Cardiol ; 119(9): 1438-1442, 2017 05 01.
Artigo em Inglês | MEDLINE | ID: mdl-28325569

RESUMO

Advanced chronic kidney disease (CKD) is associated with poor outcomes in patients who underwent surgical aortic valve replacement, whereas its prognostic role in transcatheter aortic valve implantation (TAVI) remains unclear. This study aimed to investigate outcomes in patients with advanced CKD who underwent TAVI. A total of 1,904 consecutive patients who underwent balloon-expandable TAVI in 33 centers between 2007 and 2012 were enrolled in the Italian Transcatheter Balloon-Expandable Valve Implantation Registry. Advanced CKD was defined according to the estimated glomerular filtration rate: 15 to 29 ml/min/1.73 m2 stage 4 (S4), <15 ml/min/1.73 m2 stage 5 (S5). Edwards Sapien or Sapien-XT prosthesis were used. The primary end point was all-cause mortality during follow-up. Secondary end points were major adverse cardiac events at 30 days and at follow-up, defined with Valve Academic Research Consortium 2 criteria. A total of 421 patients were staged S5 (n = 74) or S4 (n = 347). S5 patients were younger and had more frequently porcelain aorta and a lower incidence of previous stroke. Periprocedural and 30-day outcomes were similar in S5 and S4 patients. During 670 (±466) days of follow-up, S5 patients had higher mortality rates (69% vs 39%, p <0.01) and cardiac death (19% vs 9%, p = 0.02) compared with S4 patients. Male gender (hazard ratio [HR] 1.6, 95% confidence interval [CI] 1.2 to 2.2), left ventricular ejection fraction <30% (HR 2.3, 95% CI 1.3 to 4), atrial fibrillation (HR 1.4, 95% CI 1.0 to 1.9), and S5 CKD (HR 1.5, 95% CI 1.0 to 2.1) were independent predictors of death. In conclusion, TAVI in predialytic or dialytic patients (i.e., S5) is independently associated with poor outcomes with more than double risk of death compared with patients with S4 renal function. Conversely, in severe CKD (i.e., S4) a rigorous risk stratification is required to avoid the risk of futility risk.


Assuntos
Estenose da Valva Aórtica/cirurgia , Taxa de Filtração Glomerular , Falência Renal Crônica/terapia , Mortalidade , Complicações Pós-Operatórias/epidemiologia , Sistema de Registros , Diálise Renal , Substituição da Valva Aórtica Transcateter , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/complicações , Fibrilação Atrial/epidemiologia , Feminino , Humanos , Falência Renal Crônica/complicações , Masculino , Modelos de Riscos Proporcionais , Insuficiência Renal Crônica/complicações , Índice de Gravidade de Doença , Fatores Sexuais , Volume Sistólico , Resultado do Tratamento
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