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1.
Int J Cardiol ; 2019 Nov 06.
Artigo em Inglês | MEDLINE | ID: mdl-31718825

RESUMO

BACKGROUND: The aim of this study was to compare the 12-month clinical outcomes of patients treated with Magmaris or Orsiro. Second generation drug-eluting absorbable metal scaffold Magmaris (Dreams 2G) has proved to be safe and effective in the BIOSOLVE-II study. Similarly, biodegradable polymer sirolimus-eluting stent, Orsiro has shown notable clinical results even in all-comer populations. METHODS: Magmaris group patients were taken from the BIOSOLVE-II and BIOSOLVE-III trials, while the patients from Orsiro group were enrolled in BIOFLOW-II trial. The primary outcome was explored using a time-to-event assessment of the unadjusted clinical outcomes for target lesion failure (TLF) at 12 months, followed by a multivariate analysis adjusting for all the significantly different covariates between the groups. RESULTS: The study population consisted of 482 patients (521 lesions), 184 patients (189 lesions) in Magmaris group and 298 patients (332 lesions) in Orsiro group. The mean age was 65.5 ±â€¯10.8 and 62.7 ±â€¯10.4 years in Magmaris and Orsiro groups, respectively (p = 0.005). Magmaris and Orsiro unadjusted TLF rates were 6.0 and 6.4% with no significant difference between the groups (p = 0.869). In the multivariate analysis, there were no meaningful differences between Magmaris and Orsiro groups. Finally, none of the groups presented device thrombosis cases at 12 months. CONCLUSION: At 12 months there were no significant differences between Magmaris and Orsiro groups neither in the unadjusted assessment nor in the multivariate analysis for target lesion failure. These results should be taken as hypothesis generating and may warrant a head to head comparison on a randomized fashion.

3.
J. Am. Coll. Cardiol. ; 74(13 supl.): 187-187, Oct., 2019.
Artigo em Inglês | Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: biblio-1024965

RESUMO

BACKGROUND: Assessment of the safety and clinical performance of the Sirolimus-Eluting Bioabsorbable Magnesium Scaffold (DREAMS 2G) from the combined analysis of BIOSOLVE- II and -III studies at 36 months. METHODS A total of 184 subjects have been enrolled in the BIOSOLVE-II and -III studies. Clinical follow-ups are scheduled at 1, 6, 12, 24, and 36 months plus 60 months for BIOSOLVE-II. Angiographies are planned at 6 months and voluntarily at 12 and 36 months in BIOSOLVE-II, and 1 angiography is mandatory at 12 months in the BIOSOLVE-III study. Dual antiplatelet therapy is recommended for a minimum of 6 months. The angiographic results are analyzed by an independent core laboratory and all clinical events were adjudicated by an independent clinical events committee. RESULTS A total of 117 men and 67 women with 189 lesions, mean age 65.5 _ 10.8 years, were enrolled at 18 sites in Europe, Brazil, and Singapore. Hypertension was presente in 79.3% of the subjects and 62% had hyperlipidemia. The mean lesion length was 12.6 _ 5.1 mm with a mean reference vessel diameter of 2.70 _ 0.43 mm. At 12 months, 97 patients had available angiographic follow-up. There was no difference in late lumen loss between the 2 studies; in the overall population, it was 0.25 _ 0.31 mm in-segment and 0.39 _ 0.34 mm in-scaffold. The target lesion failure (TLF) rate of the combined population was 3.3%, including 2 cardiac deaths (1.1%), 1 target vessel myocardial infarction (0.6%), and 3 clinically driven target lesion revascularizations (1.7%). The 36-month clinical data of BIOSOLVE- II study are available. Target lesion failure occurred in 8 patients (6.8%) and included 2 cardiac deaths (1.7%), 1 target vessel myocardial infarction (0.9%), and 5 clinically driven target lesion revascularizations (4.3%). No definite or probable scaffold thrombosis was observed. The 36- month clinical visits are ongoing for BIOSOLVE-III patients and data of the combined cohort will be available upon presentation. CONCLUSION The 36-month results of DREAMS 2G, meaning 2 years beyond the completion of resorption, are encouraging on safety and clinical performance standpoints. They will be presented for a larger population of subjects enrolled in the BIOSOLVE-II and -III studies. (AU)


Assuntos
Reestenose Coronária , Stents Farmacológicos
4.
Cardiol Ther ; 2019 Jul 27.
Artigo em Inglês | MEDLINE | ID: mdl-31350729

RESUMO

INTRODUCTION: Rotational atherectomy (RA) historically was contraindicated in patients with impaired left ventricular (LV) function due to inherent cardio-depressive effects. Contemporary RA practice is less aggressive than traditional RA and no longer withheld from patients with reduced ejection fraction (EF). The aim of this analysis is to explore the outcomes of rotational atherectomy (RA) in patients with reduced left ventricular ejection fraction (LVEF). METHODS: Patients undergoing RA (n = 644) were divided into three groups according to LVEF (severely reduced ≤ 35%, n = 82; moderately reduced 36-54%, n = 170; and preserved LVEF ≥ 55%, n = 392). RESULTS: Compared to patients with preserved LVEF, those with severely reduced LVEF had higher rates of angiographic failure (12.2 vs. 3.3%, p = 0.003) and in-hospital major adverse cardiac events (MACE: 9.8 vs. 2.3%, p = 0.004) driven by more peri-procedural myocardial infarction (MI: 6.1 vs. 1.5%, p = 0.049). In-hospital outcomes were similar between patients with preserved and moderately reduced LVEF. At 5-year follow-up, a stepwise increase in all-cause death was observed with lower LVEF (preserved: 15%, moderately reduced: 23%, severely reduced: 43%; p < 0.001). On the other hand, revascularization and MI rates at 5 years were not affected by LVEF. CONCLUSIONS: Compared to patients with preserved LVEF, those with severely reduced LVEF have worse acute outcomes after RA, whereas a moderate reduction of LVEF poses no additional acute hazard after RA. Up to 5 years, the extent of left ventricular dysfunction was associated with a stepwise increase in mortality.

5.
Cardiovasc Revasc Med ; 20(5): 392-398, May 2019. ilus, tab
Artigo em Inglês | Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: biblio-1006900

RESUMO

Introduction and objective: The edge vascular response (EVR) remains unknown in second generation drugeluting Resorbable Magnesium Scaffold (RMS), such as Magmaris. The aim of the study was to evaluate tissue modifications in the RMS edges over time, assessed by different invasive imaging modalities. Methods: The patients treated with the device were assessed by optical coherence tomography (OCT), grayscale intravascular ultrasound (IVUS), and virtual histology IVUS at baseline and 12 months. The EVR study performed a segment- and frame-level analysis of the 5 mm segments proximal and distal of the actual RMS. Results: The segment-level grayscale IVUS (n=10), virtual histology IVUS (n=10), and OCT (n=18) analysis did not showany significant changes after 12months, except for a fibrous plaque area (FPA) reduction of 0.5mm2 (p=0.017) in the proximal segment compared to baseline. In the frame-level analysis, IVUS evaluation revealed a vessel area decreased 2.80 ± 1.43 mm2 (p = 0.012) and 2.49 ± 1.53 mm2 (p = 0.022) in 2 proximal frames. This was accompanied by plaque area reduction of 0.88 ± 0.70 mm2 (p = 0.048) and a FPA decreased by 0.63 ± 0.48mm2 (p = 0.004) in one proximal frame. In 1 distal frame, there was a dense calcium area reduction of 0.10 ± 0.12 mm2 (p = 0.045), FPA and fibrous fatty plaque increased 0.54 ± 0.53 mm2 (p = 0.023) and 0.17 ± 0.16 mm2 (p = 0.016), respectively. By OCT, there was a lumen area decrease of 0.76 ± 1.51 mm2 (p = 0.045) in a distal frame. Conclusion: At 12 months, Magmaris EVR assessment does not show overall significant changes, except for a fibrous plaque area reduction in the proximal segment. This could be translated as a benign healing process a the edges of the RMS. Summary: The edge vascular response (EVR) remains unknown in second generation drug-eluting absorbable metal scaffolds (RMS), such as Magmaris. Patients treated with the device were assessed by multi invasive imagingmodalities [i.e. optical coherence tomography (OCT), grayscale intravascular ultrasound (IVUS), and virtual histology IVUS] evaluating the tissue changes over timein the segment- and frame-level analysis of the 5mm segments proximal and distal of the actual RMS. As a result, after 12months, Magmaris EVR assessment does not show overall significant changes, except for a fibrous plaque area reduction in the proximal segment, translating a benign healing process at the edges of the RMS.


Assuntos
Humanos , Ultrassonografia de Intervenção , Tomografia de Coerência Óptica
6.
Cardiovasc Revasc Med ; 20(5): 392-398, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-31079817

RESUMO

INTRODUCTION AND OBJECTIVE: The edge vascular response (EVR) remains unknown in second generation drug-eluting Resorbable Magnesium Scaffold (RMS), such as Magmaris. The aim of the study was to evaluate tissue modifications in the RMS edges over time, assessed by different invasive imaging modalities. METHODS: The patients treated with the device were assessed by optical coherence tomography (OCT), grayscale intravascular ultrasound (IVUS), and virtual histology IVUS at baseline and 12 months. The EVR study performed a segment- and frame-level analysis of the 5 mm segments proximal and distal of the actual RMS. RESULTS: The segment-level grayscale IVUS (n = 10), virtual histology IVUS (n = 10), and OCT (n = 18) analysis did not show any significant changes after 12 months, except for a fibrous plaque area (FPA) reduction of 0.5mm2 (p = 0.017) in the proximal segment compared to baseline. In the frame-level analysis, IVUS evaluation revealed a vessel area decreased 2.80 ±â€¯1.43 mm2 (p = 0.012) and 2.49 ±â€¯1.53 mm2 (p = 0.022) in 2 proximal frames. This was accompanied by plaque area reduction of 0.88 ±â€¯0.70 mm2 (p = 0.048) and a FPA decreased by 0.63 ±â€¯0.48 mm2 (p = 0.004) in one proximal frame. In 1 distal frame, there was a dense calcium area reduction of 0.10 ±â€¯0.12 mm2 (p = 0.045), FPA and fibrous fatty plaque increased 0.54 ±â€¯0.53 mm2 (p = 0.023) and 0.17 ±â€¯0.16 mm2 (p = 0.016), respectively. By OCT, there was a lumen area decrease of 0.76 ±â€¯1.51 mm2 (p = 0.045) in a distal frame. CONCLUSION: At 12 months, Magmaris EVR assessment does not show overall significant changes, except for a fibrous plaque area reduction in the proximal segment. This could be translated as a benign healing process at the edges of the RMS. SUMMARY: The edge vascular response (EVR) remains unknown in second generation drug-eluting absorbable metal scaffolds (RMS), such as Magmaris. Patients treated with the device were assessed by multi invasive imaging modalities [i.e. optical coherence tomography (OCT), grayscale intravascular ultrasound (IVUS), and virtual histology IVUS] evaluating the tissue changes over time in the segment- and frame-level analysis of the 5 mm segments proximal and distal of the actual RMS. As a result, after 12 months, Magmaris EVR assessment does not show overall significant changes, except for a fibrous plaque area reduction in the proximal segment, translating a benign healing process at the edges of the RMS.

7.
Int J Cardiol ; 288: 39-43, 2019 08 01.
Artigo em Inglês | MEDLINE | ID: mdl-30948219

RESUMO

BACKGROUND: The management of patients with mitral regurgitation (MR) undergoing transcatheter aortic valve replacement (TAVR) is challenging. We sought to investigate the evolution and long-term prognostic impact of residual post-TAVR MR. METHODS: The severity of MR was assessed at baseline and at 30 days and six months post-TAVR. Left ventricular mass and volumes were assessed by magnetic resonance imaging at two weeks and six months post-TAVR. RESULTS: The study included 970 patients (age, 80.6 ±â€¯6.2 years; female, 53.2%; Society of Thoracic Surgeons score, 5.2 ±â€¯4.6). Moderate-severe MR at baseline improved at 30-day post-TAVR in 60% of cases, and TAVR with the Medtronic CoreValve (OR: 0.44 [0.23-0.86]) was associated with a lower likelihood of improvement. Further MR improvement continued beyond 30 days post-TAVR especially in patients with a significant improvement of left ventricular volume and mass. Stratified by the severity of MR at 30 days post-TAVR, the 5-year cumulative incidence of the composite of cardiovascular mortality or heart failure hospitalization was 37.5%, 40.0%, and 58.2% in patients with none-mild, moderate, and severe MR, respectively (log rank p < .001; adjusted hazard ratio of severe vs. none-mild MR: 4.83 [2.49-9.38]. CONCLUSIONS: MR improves in a majority of patients early after TAVR, and its evolution continues thereafter in line with reverse cardiac remodeling. Residual post-TAVR severe MR is associated with adverse long-term outcome. Therefore, intervention to treat severe MR persisting after TAVR should be considered by the heart team.

8.
Cardiovasc. revasc. med ; 20: 392-386, May 2019. ilus., tab
Artigo em Inglês | Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: biblio-998567

RESUMO

INTRODUCTION AND OBJECTIVE: The edge vascular response (EVR) remains unknown in second generation drugeluting Resorbable Magnesium Scaffold (RMS), such as Magmaris. The aim of the study was to evaluate tissue modifications in the RMS edges over time, assessed by different invasive imaging modalities. METHODS: The patients treated with the device were assessed by optical coherence tomography (OCT), grayscale intravascular ultrasound (IVUS), and virtual histology IVUS at baseline and 12 months. The EVR study performed a segment- and frame-level analysis of the 5 mm segments proximal and distal of the actual RMS. RESULTS: The segment-level grayscale IVUS (n=10), virtual histology IVUS (n=10), and OCT (n=18) analysis did not showany significant changes after 12months, except for a fibrous plaque area (FPA) reduction of 0.5mm2 (p=0.017) in the proximal segment compared to baseline. In the frame-level analysis, IVUS evaluation revealed a vessel area decreased 2.80 ± 1.43 mm2 (p = 0.012) and 2.49 ± 1.53 mm2 (p = 0.022) in 2 proximal frames. This was accompanied by plaque area reduction of 0.88 ± 0.70 mm2 (p = 0.048) and a FPA decreased by 0.63 ± 0.48mm2 (p = 0.004) in one proximal frame. In 1 distal frame, there was a dense calcium area reduction of 0.10 ± 0.12 mm2 (p = 0.045), FPA and fibrous fatty plaque increased 0.54 ± 0.53 mm2 (p = 0.023) and 0.17 ± 0.16 mm2 (p = 0.016), respectively. By OCT, there was a lumen area decrease of 0.76 ± 1.51 mm2 (p =0.045) in a distal frame. CONCLUSION: At 12 months, Magmaris EVR assessment does not show overall significant changes, except for a fibrous plaque area reduction in the proximal segment. This could be translated as a benign healing process at the edges of the RMS. SUMMARY: The edge vascular response (EVR) remains unknown in second generation drug-eluting absorbable metal scaffolds (RMS), such as Magmaris. Patients treated with the device were assessed by multi invasive imagingmodalities [i.e. optical coherence tomography (OCT), grayscale intravascular ultrasound (IVUS), and virtual histology IVUS] evaluating the tissue changes over timein the segment- and frame-level analysis of the 5mm segments proximal and distal of the actual RMS. As a result, after 12months, Magmaris EVR assessment does not show overall significant changes, except for a fibrous plaque area reduction in the proximal segment, translating a benign healing process at the edges of the RMS.


Assuntos
Humanos , Ultrassonografia de Intervenção , Tomografia de Coerência Óptica
9.
Circ Cardiovasc Interv ; 11(10): e007415, 2018 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-30354632

RESUMO

BACKGROUND: Balloon dilatation or debulking seems to be essential to allow successful stent implantation in calcified coronary lesions. Compared with standard balloon predilatation, debulking using high-speed rotational atherectomy (RA) is associated with higher initial procedural success albeit with higher in-stent late lumen loss at intermediate-term follow-up. Whether modified (scoring or cutting) balloons (MB) could achieve similar procedural success compared with RA is not known. In addition, whether new-generation drug-eluting stents could counterbalance the excessive neointimal proliferation triggered by RA remains to be determined. METHODS AND RESULTS: We randomly assigned patients with documented myocardial ischemia and severely calcified native coronary lesions undergoing percutaneous coronary intervention to a strategy of lesion preparation using MB or RA followed by drug-eluting stent implantation. Stenting was performed using a third-generation sirolimus-eluting stent with a bioabsorbable polymer. The trial had 2 primary end points: strategy success (defined as successful stent delivery and expansion with attainment of <20% in-stent residual stenosis in the presence of TIMI [Thrombolysis in Myocardial Infarction] 3 flow without crossover or stent failure; powered for superiority) and in-stent late lumen loss at 9 months (powered for noninferiority). Two hundred patients were enrolled at 2 centers in Germany (n=100 in each treatment group). The mean age of the study population was 74.9±7.0 years; 76% were men, and 33.5% had diabetes mellitus. Strategy success was significantly more common in the RA group (81% versus 98%; relative risk of failure with an MB- versus RA-based strategy, 9.5; 95% CI, 2.3-39.7; P=0.0001), but mean fluoroscopy time was longer (19.6±13.4 versus 23.9±12.2 minutes; P=0.03). At 9 months, mean in-stent late lumen loss was 0.16±0.39 mm in the MB group and 0.22±0.40 mm in the RA group ( P=0.21, P=0.02 for noninferiority). Target lesion revascularization (7% versus 2%; P=0.17), definite or probable stent thrombosis (0% versus 0%; P=1.00), and target vessel failure (8% versus 6%; P=0.78) were low and not significantly different between the MB and RA groups. CONCLUSIONS: Lesion preparation with upfront RA before drug-eluting stent implantation is feasible in nearly all patients with severely calcified coronary lesions, is more commonly successful as a primary strategy compared with MB, and is not associated with excessive late lumen loss. A strategy of provisional MB remains feasible, safe, and effective as long as bailout RA is readily available and may offer the advantages of compatibility with smaller sized catheters and less irradiation. Both strategies are associated with excellent clinical outcome at 9 months. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02502851.

10.
Catheter Cardiovasc Interv ; : e27842, 2018 Sep 09.
Artigo em Inglês | MEDLINE | ID: mdl-30196568

RESUMO

OBJECTIVES: We aimed to investigate the feasibility, safety, and outcome of rotational atherectomy (RA) in the setting of acute coronary syndrome (ACS). BACKGROUND: Limited data are available on the use of RA in patients presenting with ACS. METHODS: This analysis is from an observational registry, which enrolled all consecutive patients undergoing RA in a tertiary center. Between 2002 and 2015, 433 patients with stable coronary artery disease (SCAD) were treated with RA. Within the same period, 108 patients with ACS (8 STEMI and 100 NSTE-ACS) were treated with RA. Procedural success was similar between the ACS and the SCAD groups (96.6% vs. 96.4%, P = 0.90), and no significant difference was observed in procedural complications (slow-flow: 0.8% vs. 2.8%, P = 0.32; coronary dissection: 6.8% vs. 7.2%, P = 1.00; coronary perforation: 0.8% vs. 1.7%, P = 0.69). In-hospital MACE rates were comparable (3.7% vs. 3.2%, P = 0.77). The risk of MACE within 24 months was higher in ACS patients (39.9% vs. 22.4%, log-rank P = 0.002; HR: 1.39; 95% CI: 1.12-1.73; P = 0.003). Multivariable Cox regression analysis identified left ventricular ejection fraction (HR 0.97; 95% CI: 0.85-0.99; P = 0.001), treatment with a BMS (HR 2.22, 95% CI: 1.15-4.25, P = 0.02) or early generation drug eluting stent (HR 1.99; 95% CI 1.09-3.64; P = 0.03), as well as ACS presentation (HR 1.53; 95% CI: 1.02-2.29; P = 0.04) as predictors of MACE at two years. CONCLUSIONS: RA is technically feasible and safe in high risk patients presenting with ACS. However, successful application of RA did not mitigate the higher rate of long term cardiovascular events.

11.
Cardiol Ther ; 7(1): 89-99, 2018 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-29164408

RESUMO

INTRODUCTION: New-generation drug-eluting stents (NG-DES) are superior to early generation DES (EG-DES) in the majority of lesion and patient subsets, but comparative data in patients with severely calcified coronary lesions are lacking. This study aims to compare clinical outcomes of EG-DES and NG-DES in patients undergoing rotational atherectomy (RA) in calcified lesions. METHODS: Data of 268 patients (288 lesions) treated with EG-DES and 213 patients (225 lesions) receiving NG-DES after RA were retrospectively analyzed from a single-center registry. All major adverse cardiac events (MACE) were assessed at 2 years. RESULTS: Compared to the EG-DES group, patients with NG-DES more commonly had diabetes mellitus (31.9% vs. 40.9%; p = 0.04), left main lesions (7.6% vs. 17.3%; p < 0.001) and chronic total occlusions (3.5% vs. 8.5%; p = 0.016), and had a higher total stent length (30.5, IQR 20-40 mm, vs. 38, IQR 22-53 mm, p < 0.001). The Kaplan-Meier estimated rate of cardiovascular events at 2 years showed a lower incidence of death (13.5% vs. 8.2%, log-rank p = 0.13; adjusted HR after Cox regression analysis 0.49; 95% CI 0.26-0.92; p = 0.03) and a lower MACE rate (31.1% vs. 21.1%, log-rank p = 0.04; adjusted HR 0.65; 95% CI 0.42-0.98; p = 0.04) in the NG-DES group. CONCLUSIONS: Although RA is performed in more complex patients and lesions in the NG-DES era, use of NG-DES is associated with lower rates of death and MACE at 2 years as compared to EG-DES.

12.
EuroIntervention ; 12(13): 1667-1673, 2017 Jan 20.
Artigo em Inglês | MEDLINE | ID: mdl-28106001

RESUMO

AIMS: The use of large-diameter sheaths carries the risk of significant vascular and bleeding complications after transfemoral transcatheter aortic valve implantation (TAVI). In this analysis, we sought to assess the impact of a modified femoral artery puncture technique using digital subtraction angiography (DSA) and road mapping during transfemoral TAVI on periprocedural vascular and bleeding events. METHODS AND RESULTS: This is a retrospective analysis of transfemoral TAVI patients included in a prospective institutional database. The modified femoral artery puncture technique using DSA-derived road mapping guidance was introduced in October 2012. Before the introduction of this technique, vascular puncture was acquired based on an integration of angiographic data, the bony iliofemoral landmarks and a radiopaque object. Consecutive patients who underwent TAVI with the road mapping technique (RM group, n=160) were compared with consecutive patients who underwent TAVI without road mapping (control group, n=160) prior to its introduction. A standardised strategy of periprocedural anticoagulation was adopted in both groups as well as the use of a single suture-based closure device. All endpoints were defined according to the VARC-2 criteria for event definition. The mean age in the RM group was 80±7.7 years compared to 81±5.9 years in the control group (p=0.19), and females were equally distributed between both groups (63.1% vs. 58.1%, p=0.36). The baseline logistic EuroSCORE was 20.7±14.4% vs. 24.9±15.2% in the RM and control group, respectively (p=0.01). Notably, sheath size was significantly larger in the RM compared to the control group due to the more frequent use of the 20 Fr sheath (23.8% vs. 1.8%, p<0.001, respectively) associated with the more frequent implantation of the 29 mm Edwards SAPIEN XT valve in the RM group (43.8% vs. 7%, respectively, p<0.001). Despite the latter finding, both major vascular complications and major bleeding at 30 days were significantly lower in the RM group compared to the control group (4.3% vs. 11.8%, p=0.01, and 14.4% vs. 25.6%, p=0.01). An analysis limited to access site-related complications also revealed lower events in the road map group but did not reach statistical significance (8.1% vs. 13.8%, p=0.1). Other forms of vascular and bleeding complications as well as all-cause mortality were comparable in both groups. CONCLUSIONS: A modified femoral artery puncture technique using DSA and road mapping was associated with a reduction in major vascular and bleeding complications after transfemoral TAVI, and provides a simple and effective strategy for potentially improving patient outcomes.


Assuntos
Estenose da Valva Aórtica/cirurgia , Artéria Femoral , Implante de Prótese de Valva Cardíaca , Hemorragia/etiologia , Substituição da Valva Aórtica Transcateter , Idoso , Idoso de 80 Anos ou mais , Angiografia Digital/efeitos adversos , Angiografia Digital/métodos , Cateterismo Cardíaco/métodos , Feminino , Implante de Prótese de Valva Cardíaca/métodos , Humanos , Masculino , Estudos Retrospectivos , Fatores de Risco , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/métodos , Resultado do Tratamento
13.
J Interv Cardiol ; 30(2): 124-133, 2017 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-27990696

RESUMO

OBJECTIVES: The aim of this study was to compare outcomes of bailout and planned rotational atherectomy (RA) in the treatment of calcified coronary lesions. BACKGROUND: Current guidelines recommend RA as a bailout procedure for calcified or fibrotic lesions that cannot be adequately dilated before stenting. Nonetheless, planned RA is sometimes performed in certain challenging anatomies. METHODS: Data of patients treated with RA between 2002 and 2014 at a single-center registry were retrospectively analyzed. The bailout RA group included patients where RA was employed after failure of balloon dilatation or stent delivery. Planned RA included patients where RA was employed electively without previous device failure. RESULTS: The study comprised 204 patients (221 lesions) and 308 patients (338 lesions) treated with bailout or planned RA, respectively. Angiographic success was achieved in the majority of cases, but was lower in the bailout RA group (93.7% vs. 97.6%, P = 0.02). Coronary dissections occurred more frequently in the bailout RA group (8.6% vs. 4.4%, P = 0.04), mean contrast amount was higher (279 ± 135 mL vs. 202 ± 92 mL, P < 0.001), and fluoroscopy time and procedural duration were longer in that group (32 min [IQR 21-51] vs. 18 min [IQR 14-28], P < 0.001 and 111 ± 50 min vs. 76 ± 35 min, P < 0.001, respectively). In-hospital death and myocardial infarction were not significantly different between the groups (2.9% vs. 1.3%, P = 0.21 and 6.9% vs. 4.2%, P = 0.19). In-hospital major adverse cardiac events (MACE) were higher in the bailout RA group (10.3% vs. 5.5%, P = 0.04). The 2-year estimated rates of MACE (25.2% vs. 28.7%, log rank P = 0.52) and its components death, myocardial infarction, and target vessel revascularization were not significantly different between the groups. Equivalence of 2-year MACE rates was also seen in all examined subgroups. CONCLUSION: Shortened procedural duration and reduction of coronary dissections were observed with planned RA for selected lesions. However, this strategy does not affect long-term clinical outcomes.


Assuntos
Aterectomia Coronária , Doença da Artéria Coronariana/cirurgia , Calcificação Vascular/cirurgia , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Seleção de Pacientes , Estudos Retrospectivos , Stents , Fatores de Tempo , Resultado do Tratamento
14.
Cardiovasc Revasc Med ; 17(6): 391-8, 2016 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-27396607

RESUMO

OBJECTIVES: Percutaneous coronary intervention (PCI) after transcatheter aortic valve implantation (TAVI) can become technically challenging after implantation of the self-expanding Medtronic CoreValve (MCV) device, which completely covers the aortic root. The aim of this study was to report on the incidence, feasibility and outcome of PCI after TAVI with the MCV device. METHODS: Between 2007 and 2014, all patients subjected to PCI after MCV implantation in a single-center institutional TAVI database were retrospectively identified. Clinical, angiographic and procedural characteristics were reviewed and analyzed. RESULTS: We identified a total of 17 patients (5.7%) treated with 24 PCI procedures for 29 lesions at a median of 17.7months (range 1-72) after MCV implantation. The mean age was 79.7±6.8years and the mean logistic EuroSCORE was 30.3%±18.9%. Nine procedures were performed for patients with acute coronary syndrome. 89.6% of the treated lesions were of type B2/C and 79.3% were de novo ones. A median of one guiding catheter was necessary to intubate the target coronary ostium (range 1-10) and 95% of the lesions on the left coronary artery were treated through a Judkins catheter. In one primary PCI for STEMI the intubation of the right coronary ostium was not successful. Final procedural success was obtained in 95.8%, and peri-procedural death occurred in one patient. CONCLUSIONS: The need for PCI after MCV is not uncommon and is mostly related to coronary artery disease progression. PCI after MCV is usually feasible and safe, but coronary intubation in an emergency setting can be challenging.


Assuntos
Estenose da Valva Aórtica/terapia , Valva Aórtica , Cateterismo Cardíaco/instrumentação , Doença da Artéria Coronariana/terapia , Implante de Prótese de Valva Cardíaca/instrumentação , Próteses Valvulares Cardíacas , Intervenção Coronária Percutânea/instrumentação , Stents , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/fisiopatologia , Cateterismo Cardíaco/efeitos adversos , Distribuição de Qui-Quadrado , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Bases de Dados Factuais , Estudos de Viabilidade , Feminino , Alemanha , Implante de Prótese de Valva Cardíaca/efeitos adversos , Humanos , Modelos Logísticos , Masculino , Intervenção Coronária Percutânea/efeitos adversos , Desenho de Prótese , Estudos Retrospectivos , Fatores de Risco , Resultado do Tratamento
15.
Eur Heart J ; 37(35): 2701-9, 2016 09 14.
Artigo em Inglês | MEDLINE | ID: mdl-27190094

RESUMO

AIMS: Metal absorbable scaffolds constitute a conceptually attractive alternative to polymeric scaffolds. Promising 6-month outcomes of a second-generation drug-eluting absorbable metal scaffold (DREAMS 2G), consisting of an absorbable magnesium scaffold backbone, have been reported. We assessed the 12-month safety and performance of this novel device. METHODS AND RESULTS: The prospective, international, multi-centre, first-in-man BIOSOLVE-II trial enrolled 123 patients with up to two de novo lesions with a reference diameter between 2.2 and 3.7 mm. All patients were scheduled for angiographic follow-up at 6 months, and-if subjects consented-at 12 months. Dual antiplatelet therapy was recommended for 6 months. Quantitative coronary angiography (QCA) parameters remained stable from 6 to 12 months [paired data of 42 patients: in-segment late lumen loss 0.20 ± 0.21 mm vs. 0.25 ± 0.22 mm, P = 0.117, Δ 0.05 ± 0.21 mm (95% CI: -0.01;0.12); in-scaffold late lumen loss 0.37 ± 0.25 mm vs. 0.39 ± 0.27 mm, P = 0.446, Δ 0.03 ± 0.22 (95% CI: -0.04;0.10), respectively]. Intravascular ultrasound and optical coherence tomography findings corroborated the QCA results. Target lesion failure occurred in four patients (3.4%), consisting of one death of unknown cause, one target-vessel myocardial infarction, and two clinically driven target lesion revascularization. No additional event occurred beyond the 6-month follow-up. During the entire follow-up of 12 months, none of the patients experienced a definite or probable scaffold thrombosis. CONCLUSION: The novel drug-eluting metal absorbable scaffold DREAMS 2G showed a continuous favourable safety profile up to 12 months and stable angiographic parameters between 6 and 12 months. CLINICALTRIALSGOV IDENTIFIER: NCT01960504.


Assuntos
Stents Farmacológicos , Implantes Absorvíveis , Angiografia Coronária , Doença da Artéria Coronariana , Humanos , Metais , Estudos Prospectivos , Sirolimo , Resultado do Tratamento
16.
Catheter Cardiovasc Interv ; 87(4): 691-700, 2016 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-26525804

RESUMO

BACKGROUND: In the randomized ROTAXUS trial, routine lesion preparation of complex calcified coronary lesions using rotational atherectomy (RA) prior to paclitaxel-eluting stent implantation did not reduce the primary endpoint of angiographic late lumen loss at 9 months compared to stenting without RA. So far, no long-term data of prospective head-to-head comparisons between both treatment strategies have been reported. METHODS AND RESULTS: ROTAXUS randomly assigned patients with complex calcified coronary lesions to RA followed by stenting (n = 120) or stenting without RA (n = 120). The primary endpoint of the current analysis was the occurrence of major adverse cardiac events (MACE) at 2-year follow-up defined as the composite of death, myocardial infarction, and target vessel revascularization (TVR). At 2 years, MACE occurred in 32 patients in the RA group and 37 patients in the standard therapy group (29.4% vs. 34.3%, P = 0.47). The rates of death (8.3% vs. 7.4%, P = 1.00), myocardial infarction (8.3% vs. 6.5%, P = 0.80), target lesion revascularization (TLR, 13.8% vs. 16.7%, P = 0.58), and TVR (19.3% vs. 22.2%, P = 0.62) were similar in both groups. CONCLUSION: Despite high rates of initial angiographic success, nearly one third of patients enrolled in ROTAXUS experienced MACE within 2-year follow-up, with no differences between patients treated with or without RA.


Assuntos
Aterectomia Coronária , Fármacos Cardiovasculares/administração & dosagem , Doença da Artéria Coronariana/terapia , Stents Farmacológicos , Paclitaxel/administração & dosagem , Intervenção Coronária Percutânea/instrumentação , Calcificação Vascular/terapia , Idoso , Aterectomia Coronária/efeitos adversos , Aterectomia Coronária/mortalidade , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/mortalidade , Feminino , Alemanha , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/etiologia , Infarto do Miocárdio/mortalidade , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Estudos Prospectivos , Desenho de Prótese , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Calcificação Vascular/diagnóstico por imagem , Calcificação Vascular/mortalidade
17.
Lancet ; 387(10013): 31-9, 2016 Jan 02.
Artigo em Inglês | MEDLINE | ID: mdl-26470647

RESUMO

BACKGROUND: Absorbable scaffolds were designed to overcome the limitations of conventional, non-absorbable metal-based drug-eluting stents. So far, only polymeric absorbable scaffolds are commercially available. We aimed to assess the safety and performance of a novel second-generation drug-eluting absorbable metal scaffold (DREAMS 2G) in patients with de-novo coronary artery lesions. METHODS: We did this prospective, multicentre, non-randomised, first-in-man trial at 13 percutaneous coronary intervention centres in Belgium, Brazil, Denmark, Germany, Singapore, Spain, Switzerland, and the Netherlands. Eligible patients had stable or unstable angina or documented silent ischaemia, and a maximum of two de-novo lesions with a reference vessel diameter between 2·2 mm and 3·7 mm. Clinical follow-up was scheduled at months 1, 6, 12, 24, and 36. Patients were scheduled for angiographic follow-up at 6 months, and a subgroup of patients was scheduled for intravascular ultrasound, optical coherence tomography, and vasomotion assessment. All patients were recommended to take dual antiplatelet treatment for at least 6 months. The primary endpoint was in-segment late lumen loss at 6 months. We did analysis by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01960504. FINDINGS: Between Oct 8, 2013, and May 22, 2015, we enrolled 123 patients with 123 coronary target lesions. At 6 months, mean in-segment late lumen loss was 0·27 mm (SD 0·37), and angiographically discernable vasomotion was documented in 20 (80%) of 25 patients. Intravascular ultrasound assessments showed a preservation of the scaffold area (mean 6·24 mm(2) [SD 1·15] post-procedure vs 6·21 mm(2) [1·22] at 6 months) with a low mean neointimal area (0·08 mm(2) [0·09]), and optical coherence tomography did not detect any intraluminal mass. Target lesion failure occurred in four (3%) patients: one (<1%) patient died from cardiac death, one (<1%) patient had periprocedural myocardial infarction, and two (2%) patients needed clinically driven target lesion revascularisation. No definite or probable scaffold thrombosis was observed. INTERPRETATION: Our findings show that implantation of the DREAMS 2G device in de-novo coronary lesions is feasible, with favourable safety and performance outcomes at 6 months. This novel absorbable metal scaffold could be an alternative to absorbable polymeric scaffolds for treatment of obstructive coronary disease. FUNDING: Biotronik AG.


Assuntos
Implantes Absorvíveis , Antibióticos Antineoplásicos/uso terapêutico , Reestenose Coronária/patologia , Estenose Coronária/terapia , Stents Farmacológicos , Sirolimo/uso terapêutico , Tecidos Suporte , Idoso , Ligas , Estudos de Coortes , Reestenose Coronária/diagnóstico por imagem , Endossonografia , Feminino , Humanos , Magnésio , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea , Estudos Prospectivos , Tomografia de Coerência Óptica , Resultado do Tratamento
18.
Lancet ; 387(10013): 31-39, 2016.
Artigo em Inglês | Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: ses-34656

RESUMO

Absorbable scaffolds were designed to overcome the limitations of conventional, non-absorbable metal-based drug-eluting stents. So far, only polymeric absorbable scaffolds are commercially available. We aimed to assess the safety and performance of a novel second-generation drug-eluting absorbable metal scaffold (DREAMS 2G) in patients with de-novo coronary artery lesions. METHODS: We did this prospective, multicentre, non-randomised, first-in-man trial at 13 percutaneous coronary intervention centres in Belgium, Brazil, Denmark, Germany, Singapore, Spain, Switzerland, and the Netherlands. Eligible patients had stable or unstable angina or documented silent ischaemia, and a maximum of two de-novo lesions with a reference vessel diameter between 2·2 mm and 3·7 mm. Clinical follow-up was scheduled at months 1, 6, 12, 24, and 36. Patients were scheduled for angiographic follow-up at 6 months, and a subgroup of patients was scheduled for intravascular ultrasound, optical coherence tomography, and vasomotion assessment. All patients were recommended to take dual antiplatelet treatment for at least 6 months. The primary endpoint was in-segment late lumen loss at 6 months. We did analysis by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01960504...(AU)


Assuntos
Stents Farmacológicos , Doenças da Aorta , Stents
19.
Eur Heart J ; 37(35): 2701-2709, 2016.
Artigo em Inglês | Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: ses-34658

RESUMO

Aims: Metal absorbable scaffolds constitute a conceptually attractive alternative to polymeric scaffolds. Promising 6-month outcomesof a second-generation drug-eluting absorbable metal scaffold (DREAMS 2G), consisting of an absorbable magnesiumscaffold backbone, have been reported. We assessed the 12-month safety and performance of this novel device. Methods and results: The prospective, international, multi-centre, first-in-man BIOSOLVE-II trial enrolled 123 patients with up to two de novolesions with a reference diameter between 2.2 and 3.7 mm. All patients were scheduled for angiographic follow-up at6 months, and—if subjects consented—at 12 months. Dual antiplatelet therapy was recommended for 6 months. Quantitative coronary angiography (QCA) parameters remained stable from 6 to 12 months [paired data of 42patients: in-segment late lumen loss 0.20 + 0.21 mm vs. 0.25 + 0.22 mm, P ¼ 0.117, D 0.05 + 0.21 mm (95%CI: 20.01;0.12); in-scaffold late lumen loss 0.37 + 0.25 mm vs. 0.39 +0.27 mm, P ¼ 0.446, D 0.03 + 0.22 (95%CI: 20.04;0.10), respectively]. Intravascular ultrasound and optical coherence tomography findings corroboratedthe QCA results. Target lesion failure occurred in four patients (3.4%), consisting of one death of unknown cause,one target-vessel myocardial infarction, and two clinically driven target lesion revascularization. No additional eventoccurred beyond the 6-month follow-up. During the entire follow-up of 12 months, none of the patients experienceda definite or probable scaffold thrombosis...(AU)


Assuntos
Doença da Artéria Coronariana , Stents , Magnésio , Sonhos
20.
J Am Coll Cardiol ; 66(7): 791-800, 2015 Aug 18.
Artigo em Inglês | MEDLINE | ID: mdl-26271061

RESUMO

BACKGROUND: The use of a balloon-expandable transcatheter heart valve previously resulted in a greater rate of device success compared with a self-expandable transcatheter heart valve. OBJECTIVES: The aim of this study was to evaluate clinical and echocardiographic outcome data at longer term follow-up. METHODS: The investigator-initiated trial randomized 241 high-risk patients with symptomatic severe aortic stenosis and anatomy suitable for treatment with both balloon- and self-expandable transcatheter heart valves to transfemoral transcatheter aortic valve replacement with either device. Patients were followed-up for 1 year, with assessment of clinical outcomes and echocardiographic evaluation of valve function. RESULTS: At 1 year, the rates of death of any cause (17.4% vs. 12.8%; relative risk [RR]: 1.35; 95% confidence interval [CI]: 0.73 to 2.50; p = 0.37) and of cardiovascular causes (12.4% vs. 9.4%; RR: 1.32; 95% CI: 0.63 to 2.75; p = 0.54) were not statistically significantly different in the balloon- and self-expandable groups, respectively. The frequencies of all strokes (9.1% vs. 3.4%; RR: 2.66; 95% CI: 0.87 to 8.12; p = 0.11) and repeat hospitalization for heart failure (7.4% vs. 12.8%; RR: 0.58; 95% CI: 0.26 to 1.27; p = 0.19) did not statistically significantly differ between the 2 groups. Elevated transvalvular gradients during follow-up were observed in 4 patients in the balloon-expandable group (3.4% vs. 0%; p = 0.12); all were resolved with anticoagulant therapy, suggesting a thrombotic etiology. More than mild paravalvular regurgitation was more frequent in the self-expandable group (1.1% vs. 12.1%; p = 0.005). CONCLUSIONS: Despite the higher device success rate with the balloon-expandable valve, 1-year follow-up of patients in CHOICE (Randomized Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis: Medtronic CoreValve Versus Edwards SAPIEN XT Trial), with limited statistical power, revealed clinical outcomes after transfemoral transcatheter aortic valve replacement with both balloon- and self-expandable prostheses that were not statistically significantly different. (A Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis: The CHOICE Trial; NCT01645202).


Assuntos
Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/cirurgia , Valvuloplastia com Balão/tendências , Próteses Valvulares Cardíacas/tendências , Desenho de Prótese/tendências , Substituição da Valva Aórtica Transcateter/tendências , Idoso , Idoso de 80 Anos ou mais , Valvuloplastia com Balão/normas , Feminino , Seguimentos , Próteses Valvulares Cardíacas/normas , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Desenho de Prótese/normas , Fatores de Tempo , Substituição da Valva Aórtica Transcateter/normas , Resultado do Tratamento
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