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1.
J Vasc Surg ; 79(6): 1420-1427.e2, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38367850

RESUMEN

OBJECTIVE: Percutaneous transmural arterial bypass (PTAB) using the DETOUR system aims to create a percutaneous, endovascular femoropopliteal bypass for the treatment of long segment, complex superficial femoral and proximal popliteal artery disease. The goal of the DETOUR2 study is to investigate the safety and effectiveness of the therapy in comparison with pre-established performance goals. METHODS: The DETOUR2 investigational device exemption study is a prospective, single-arm, multicenter, international trial of symptomatic peripheral arterial disease patients (Rutherford classes 3-5) undergoing the DETOUR procedure for long segment (>20 cm) superficial femoral artery disease. Prespecified end points included primary safety (composite of major adverse events) at 30 days, and effectiveness (primary patency defined as freedom from restenosis or clinically driven target lesion revascularization) at 1 year. RESULTS: We enrolled 202 patients at 32 sites with 200 treated with the DETOUR system. The mean lesion length was 32.7 cm, of which 96% were chronic total occlusions (CTO) and 70% were severely calcified. Technical success was achieved in 100% of treated patients. The primary safety end point was met with a 30-day freedom from major adverse event rate of 93.0%. The 1-year primary effectiveness end point was met with 72.1% primary patency at 12 months. Primary-assisted and secondary patency were 77.7% and 89.0%, respectively, at 12 months. The 12 month deep venous thrombosis incidence was 4.1% with no pulmonary emboli reported. Venous quality-of-life scores showed no significant changes from baseline. There was a Rutherford improvement of at least one class through 12 months in 97.2% of patients. The mean ankle-brachial index also improved from 0.61 to 0.95 during this period. There were marked improvements in quality-of-life and functional status measures. CONCLUSIONS: The DETOUR2 study met both the primary safety and effectiveness end points, demonstrating clinical usefulness of this novel therapeutic strategy in long femoropopliteal lesions.


Asunto(s)
Arteria Femoral , Enfermedad Arterial Periférica , Arteria Poplítea , Grado de Desobstrucción Vascular , Humanos , Arteria Poplítea/cirugía , Arteria Poplítea/fisiopatología , Arteria Poplítea/diagnóstico por imagen , Arteria Femoral/cirugía , Arteria Femoral/fisiopatología , Arteria Femoral/diagnóstico por imagen , Enfermedad Arterial Periférica/cirugía , Enfermedad Arterial Periférica/fisiopatología , Enfermedad Arterial Periférica/diagnóstico por imagen , Masculino , Femenino , Anciano , Estudios Prospectivos , Factores de Tiempo , Persona de Mediana Edad , Resultado del Tratamiento , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/instrumentación , Calidad de Vida , Factores de Riesgo
2.
Eur J Clin Invest ; : e14237, 2024 May 17.
Artículo en Inglés | MEDLINE | ID: mdl-38757632

RESUMEN

BACKGROUND: The effectiveness of percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) is still uncertain, especially for patients with ischemic left ventricular dysfunction. This study aimed to assess hibernating myocardium (HM), as determined by single-photon emission computed tomography (SPECT) and 18F-FDG positron emission tomography (PET), and to compare the benefits of PCI and optimal medical therapy (OMT). METHODS: A retrospective study collected data from 332 patients with CTO and ischemic left ventricular dysfunction. The study compared patients who underwent PCI or OMT via propensity score matching (PSM) analysis which was performed with a 1:2 matching protocol using the nearest neighbour matching algorithm. The primary endpoint of the study was the occurrence of major adverse cardiac events (MACE), defined as a composite of cardiac death, readmission for worsening heart failure (WHF), revascularization and myocardial infarction (MI). RESULTS: After PSM, there were a total of 246 individuals in the PCI and OMT groups. Following Cox regression, hibernating myocardium/total perfusion defect (HM/TPD) was identified as an independent risk factor (hazard ratio (HR): 1.03, 95% confidence interval (CI): 1.008-1.052, p = .007). The cut-off value of HM/TPD was 38%. The results of the subgroup analysis suggest that for patients with HM/TPD >38%, the OMT group had a greater risk of MACE (p = .035). A sensitivity analysis restricting patients with single-vessel CTO lesions, HM/TPD remained an independent predictor (HR 1.025, 95% CI 1.008-1.043, p = .005). CONCLUSION: HM/TPD is an independent predictor of MACE, and for patients with HM/TPD > 38%, CTO-PCI had a lower risk of MACE compared with OMT. However, further validation is still needed through large-scale studies.

3.
Catheter Cardiovasc Interv ; 103(1): 12-19, 2024 01.
Artículo en Inglés | MEDLINE | ID: mdl-37983649

RESUMEN

BACKGROUND: Contemporary chronic total occlusion (CTO) percutaneous coronary intervention (PCI) practice has received limited study. AIM: To examine the contemporary CTO PCI practice. METHODS: We performed an online, anonymous, international survey of CTO PCI operators. RESULTS: Five hundred forty-five CTO PCI operators and 190 interventional cardiology fellows with an interest in CTO PCI participated in this survey. Almost half were from the United States (41%), most (93%) were men, and the median h/week spent in the hospital was 58. Median annual case numbers were 205 (150-328) for PCIs and 20 (5-50) for CTO PCIs. Almost one-fifth (17%) entered CTO cases into registries, such as PROGRESS-CTO (55%) and EuroCTO (20%). More than one-third worked at academic institutions (39%), 31% trained dedicated CTO fellows, and 22% proctored CTO PCI. One-third (34%) had dedicated CTO PCI days. Most (51%) never discharged CTO patients the same day, while 17% discharged CTO patients the same day >50% of the time. After successful guidewire crossing, 38% used intravascular imaging >90% of the time. Most used CTO scores including J-CTO (81%), PROGRESS-CTO (35%), and PROGRESS-CTO complications scores (30%). Coronary artery perforation was encountered within the last month by 19%. On a scale of 0-10, the median comfort levels in treating coronary artery perforation were: covered stents 8.8 (7.0-10), coil embolization 5.0 (2.1-8.5), and fat embolization 3.7 (0.6-7.3). Most (51%) participants had a complication cart/kit and 25% conducted regular complication drills with catheterization laboratory staff. CONCLUSION: Contemporary CTO PCI practices vary widely. Further research on barriers to following the guiding principles of CTO PCI may improve patient outcomes.


Asunto(s)
Oclusión Coronaria , Lesiones Cardíacas , Intervención Coronaria Percutánea , Masculino , Humanos , Estados Unidos , Femenino , Resultado del Tratamiento , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/métodos , Oclusión Coronaria/diagnóstico por imagen , Oclusión Coronaria/terapia , Enfermedad Crónica , Factores de Tiempo , Sistema de Registros , Angiografía Coronaria/métodos , Factores de Riesgo
4.
Catheter Cardiovasc Interv ; 103(1): 80-88, 2024 01.
Artículo en Inglés | MEDLINE | ID: mdl-37983650

RESUMEN

The use of the subintimal space has allowed a massive advancement in the field of chronic total occlusion percutaneous coronary intervention (PCI). The STAR technique is the first of subintimal techniques. Despite a high acute success rate, follow-up results showed unfavorable outcomes with half of the treated patients showing restenosis/reocclusion at 6 months. We present three cases in which a modification of the STAR technique guided by intravascular ultrasound (IVUS), namely the STAR 2.0, was used as a bailout for successful PCI of chronic total occlusions.


Asunto(s)
Oclusión Coronaria , Intervención Coronaria Percutánea , Humanos , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/métodos , Resultado del Tratamiento , Oclusión Coronaria/diagnóstico por imagen , Oclusión Coronaria/terapia , Oclusión Coronaria/etiología , Enfermedad Crónica , Ultrasonografía Intervencional , Angiografía Coronaria
5.
Catheter Cardiovasc Interv ; 103(1): 1-11, 2024 01.
Artículo en Inglés | MEDLINE | ID: mdl-38050646

RESUMEN

BACKGROUND: The J-chronic total occlusion (CTO) channel score can predict guidewire tracking of the collateral channels (CCs), but its efficacy in predicting microcatheter tracking has never been tested in the setting of retrograde CTO-percutaneous coronary intervention (PCI). AIMS: Predicting microcatheter collateral tracking during retrograde CTO-PCIs. METHODS: A total of 189 patients undergoing retrograde CTO-PCI from April 2017 to August 2021 were screened. The primary outcome of interest was a correlation between J-CTO channel score and microcatheter tracking failure (MTF) after successful CC tracking by the guidewire. The independent association between anatomical features of the J-CTO channel score and the primary outcome of interest was explored. RESULTS: After adjustment, only small size (adjusted OR: 12.70, 95% confidence interval [CI]: 1.79-89.82; p = 0.01) and continuous bends (adjusted OR: 14.15, 95% CI: 2.77-72.34; p < 0.001) remained significantly associated with an increased risk of MTF for septal collaterals. The small size was the only predictor of the MTF for epicardial collaterals (OR: 6.39, 95% CI: 1.13-35.96; p = 0.020) at univariate analysis. Patients in the MTF group had a lower incidence of procedural success compared with patients in the microcatheter tracking success (MTS) group (40.0% vs. 93.9%, p < 0.001) and had a higher incidence of collateral perforations (20.0% vs. 3.0%, p < 0.001). CONCLUSION: Small and tortuous septal collaterals, identified by a score ≥3, are associated with an increased risk of MTF, lower incidence of procedural success, and higher risk of procedural complications driven by collateral perforations.


Asunto(s)
Oclusión Coronaria , Intervención Coronaria Percutánea , Humanos , Intervención Coronaria Percutánea/efectos adversos , Resultado del Tratamiento , Oclusión Coronaria/diagnóstico por imagen , Oclusión Coronaria/terapia , Oclusión Coronaria/etiología , Angiografía Coronaria , Enfermedad Crónica , Circulación Colateral , Sistema de Registros , Factores de Riesgo
6.
BMC Cardiovasc Disord ; 24(1): 4, 2024 01 02.
Artículo en Inglés | MEDLINE | ID: mdl-38166554

RESUMEN

BACKGROUND AND AIM: Interventional cardiologists face challenges in managing chronic total occlusion (CTO) lesions, with conflicting results when comparing rotational atherectomy (RA) to conventional PCI. This meta-analysis aims to provide a critical evaluation of the safety and feasibility of RA in CTO lesions. METHODS: PubMed, Scopus, Web of Science, Ovid, and Cochrane central library until April 2023 were searched for relevant studies. MACE was our primary outcomes, other outcomes were all cause of death, cardiac death, MI, and TVR. Also, we reported angiographic outcomes as technical success, procedural success, and procedural complications in a random effect model. The pooled data was analyzed using odds ratio (OR) with its 95% CI using STATA 17 MP. RESULTS: Seven studies comprising 5494 patients with a mean follow-up of 43.1 months were included in this meta-analysis. Our pooled analysis showed that RA was comparable to PCI to decrease the incidence of MACE (OR = 0.98, 95% CI [0.74 to 1.3], p = 0.9). Moreover, there was no significant difference between RA and conventional PCI in terms of other clinical or angiographic outcomes. CONCLUSION: Our study showed that RA had comparable clinical and angiographic outcomes as conventional PCI in CTO lesions, which offer interventional cardiologists an expanded perspective when addressing calcified lesions. PROSPERO REGISTRATION: CRD42023417362.


Asunto(s)
Aterectomía Coronaria , Oclusión Coronaria , Intervención Coronaria Percutánea , Humanos , Enfermedad Crónica , Oclusión Coronaria/diagnóstico por imagen , Oclusión Coronaria/cirugía , Estudios de Factibilidad , Intervención Coronaria Percutánea/métodos , Factores de Riesgo , Resultado del Tratamiento
7.
Eur Heart J ; 44(30): 2805-2814, 2023 08 07.
Artículo en Inglés | MEDLINE | ID: mdl-37264699

RESUMEN

The colorful term "coronary steal" arose in 1967 to parallel "subclavian steal" coined in an anonymous 1961 editorial. In both instances, the word "steal" described flow reversal in the setting of an interconnected but abnormal vascular network-in one case a left subclavian stenosis proximal to the origin of the vertebral artery and in the other case a coronary fistula. Over time, the term has morphed to include a larger set of pathophysiology without explicit flow reversal but rather with a decrease in stress flow due to other mechanisms. This review aims to shed light on this phenomenon from a clinical and a pathophysiological perspective, detailing the anatomical and physiological conditions that allow so-called steal to appear and offering treatment options for six distinct scenarios.


Asunto(s)
Enfermedad de la Arteria Coronaria , Síndrome de Robo Coronario-Subclavio , Síndrome del Robo de la Subclavia , Humanos , Arteria Vertebral , Corazón
8.
Heart Lung Circ ; 33(6): 764-772, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38565438

RESUMEN

The percutaneous management of chronic total occlusions (CTO) is a well-established sub-specialty of Interventional Cardiology, requiring specialist equipment, training, and techniques. The heterogeneity of approaches in CTO has led to the generation of multiple algorithms to guide operators in their management. The evidence base for management of CTOs has suffered from inconsistent descriptive and quantitative terminology in defining the nature of lesions and techniques utilised, as well as seemingly contradictory data about improvement in ventricular function, symptoms of angina, and mortality from large-scale registries and randomised controlled trials. Through this review, we explore the history of CTO management and its supporting evidence in detail, with an outline of limitations of CTO-percutaneous coronary intervention and a look at the future of this growing field within cardiology.


Asunto(s)
Oclusión Coronaria , Intervención Coronaria Percutánea , Humanos , Oclusión Coronaria/diagnóstico , Oclusión Coronaria/terapia , Oclusión Coronaria/cirugía , Intervención Coronaria Percutánea/métodos , Enfermedad Crónica
9.
Catheter Cardiovasc Interv ; 102(3): 489-494, 2023 09.
Artículo en Inglés | MEDLINE | ID: mdl-37471714

RESUMEN

Coronary artery obstruction is a rare but life-threatening complication of transcatheter aortic valve replacement (TAVR). While urgent percutaneous coronary intervention has been described in cases of acute occlusion, little is known about the interventional management of obstruction once it has occurred in the chronic setting. We describe a case in which electrocautery-assisted re-entry was successfully utilized to manage the right coronary artery and left main chronic total occlusion due to leaflet-induced coronary artery obstruction after TAVR.


Asunto(s)
Estenosis de la Válvula Aórtica , Oclusión Coronaria , Intervención Coronaria Percutánea , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Resultado del Tratamiento , Oclusión Coronaria/diagnóstico por imagen , Oclusión Coronaria/etiología , Oclusión Coronaria/cirugía , Intervención Coronaria Percutánea/efectos adversos , Electrocoagulación/efectos adversos , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/complicaciones , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Factores de Riesgo
10.
Artículo en Inglés | MEDLINE | ID: mdl-36617386

RESUMEN

A novel device based CART technique (K14 technique) has been described with 2 case examples to illustrate the same. This CART has been performed after ADR and Reverse-CART were unsuccessful.

11.
Catheter Cardiovasc Interv ; 101(4): 806-812, 2023 03.
Artículo en Inglés | MEDLINE | ID: mdl-36802136

RESUMEN

Coronary artery disease (CAD) is frequently encountered in patients evaluated for transcatheter aortic valve replacement (TAVR) due to severe aortic stenosis. The prognostic relevance of chronic total occlusions (CTOs) in this setting is poorly understood. We conducted a search of MEDLINE and EMBASE to identify studies evaluating patients who underwent TAVR and evaluated outcomes depending on the presence of coronary CTOs. Pooled analysis was performed to estimate the rate and risk ratio for mortality. Four studies involving 25,432 patients fulfilled the inclusion criteria. The follow up ranged from in-hospital outcomes to 8-years follow-up. Coronary artery disease was present in 67.8% to 75.5% of patients in 3 studies which reported this variable. The prevalence of CTOs varied between 2% and 12.6% in this cohort. The presence of CTOs was associated with increase in length of stay (8.1 ± 8.2 vs. 5.9 ± 6.5, p < 0.01), cardiogenic shock (5.1% vs. 1.7%, p < 0.01), acute myocardial infarction (5.8% vs. 2.8%, p = 0.02) and acute kidney injury (18.6% vs. 13.9%, p = 0.048). The pooled 1-year death rate revealed 41 deaths in 165 patients in the CTO group and 396 deaths in 1663 patients with no CTO ((24.8%) vs. (23.8%)). The meta-analysis of death with CTO versus no CTO showed a nonsignificant trend toward increased mortality with CTOs (risk ratio 1.11 95% CI 0.90-1.40, I2 = 0%). Our analysis suggests that concomitant CTO lesions in patients undergoing TAVR are common, and its presence was associated with increased in-hospital complications. However, CTO presence by itself was not associated with increased long-term mortality, only a nonsignificant trend toward an increased risk of death in patients with CTO was found. Further studies are warranted to assess the prognostic relevance of CTO lesion in TAVR patients.


Asunto(s)
Estenosis de la Válvula Aórtica , Enfermedad de la Arteria Coronaria , Oclusión Coronaria , Infarto del Miocardio , Intervención Coronaria Percutánea , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Intervención Coronaria Percutánea/efectos adversos , Resultado del Tratamiento , Factores de Riesgo , Estenosis de la Válvula Aórtica/cirugía , Válvula Aórtica/cirugía
12.
Catheter Cardiovasc Interv ; 102(1): 71-79, 2023 07.
Artículo en Inglés | MEDLINE | ID: mdl-37194723

RESUMEN

BACKGROUND: The anatomical complexity of a chronic total occlusion (CTO) correlates with procedural failure and complication rates. CTO modification after unsuccessful crossing has been associated with subsequent higher technical success rates, but complication rates remain high with this approach. While successful CTO percutaneous coronary intervention (PCI) has been associated with improved angina and quality of life (QOL) this has not been demonstrated in anatomically high-risk CTOs. Whether a planned CTO modification procedure, hereafter named Investment procedure, could improve patient outcomes has never been investigated. STUDY DESIGN: Invest-CTO is a prospective, single-arm, international, multicenter study, evaluating the effectiveness and safety of a planned investment procedure, with a subsequent completion CTO PCI (at 8-12 weeks), in anatomically high-risk CTOs. We will enroll 200 patients with CTOs defined as high-risk according to our Invest CTO criteria at centers in Norway and United Kingdom. Patients with aorto-ostial lesions, occlusion within a previous stent, or a prior attempt at target vessel CTO PCI within 6 months will be excluded. The co-primary endpoints are cumulative procedural success (%) after both procedures, and a composite safety endpoint at 30 days after completion CTO PCI. Patient reported outcomes (PROs), treatment satisfaction, and clinical endpoints will be reported. CONCLUSION: This study will prospectively evaluate the effectiveness and safety of a planned two staged PCI procedure in the treatment of high-risk CTOs and may have the potential to change current clinical practice.


Asunto(s)
Oclusión Coronaria , Intervención Coronaria Percutánea , Humanos , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/métodos , Calidad de Vida , Factores de Riesgo , Oclusión Coronaria/diagnóstico por imagen , Oclusión Coronaria/cirugía , Resultado del Tratamiento , Estudios Prospectivos , Medición de Resultados Informados por el Paciente , Enfermedad Crónica , Sistema de Registros , Angiografía Coronaria/métodos
13.
Catheter Cardiovasc Interv ; 102(5): 900-911, 2023 11.
Artículo en Inglés | MEDLINE | ID: mdl-37668102

RESUMEN

The use of coils is fundamental in interventional cardiology and can be lifesaving in selected settings. Coils are classified by their materials into bare metal, fiber coated, and hydrogel coated, or by the deliverability method into, pushable or detachable coils. Coils are delivered through microcatheters and the choice of coil size is important to ensure compatibility with the inner diameter of the delivery catheter, firstly to be able to deliver and secondly to prevent the coil from being stuck and damaged. Clinically, coils are used in either acute or in elective setting. The most important acute indication is typically the sealing coronary perforation. In the elective settings, coils can be used for the treatment of certain congenital cardiac abnormalities, aneurysms, fistulas or in the treatment of arterial side branch steal syndrome after CABG. Coils must always be delivered under fluoroscopy guidance. There are some associated complications with coils that can be acute or chronic, that nictitates regular followed-up. There is a need for education, training and regular workshops with hands-on to build the experience to use coils in situations that are infrequently encountered.


Asunto(s)
Embolización Terapéutica , Lesiones Cardíacas , Enfermedades Vasculares , Humanos , Resultado del Tratamiento , Cateterismo Cardíaco/efectos adversos , Embolización Terapéutica/efectos adversos , Embolización Terapéutica/métodos , Fluoroscopía
14.
BMC Cardiovasc Disord ; 23(1): 85, 2023 02 12.
Artículo en Inglés | MEDLINE | ID: mdl-36774496

RESUMEN

OBJECTIVES: The right heart is mainly supplied with blood by the right coronary artery (RCA). The impact of RCA chronic total occlusion (CTO) on the function of the right heart [right atrium (RA) and ventricle (RV)] and whether successful recanalization of a RCA CTO improves the function of the right heart is not clearly understood yet. We aimed to evaluate right atrial function after recanalization of the RCA using transthoracic echocardiography with additional strain imaging. METHODS AND RESULTS: Fifty-five patients undergoing RCA CTO recanalization at the University Medical Center of Mainz were included in the study. Right atrial strain was assessed before and 6 months after successful CTO revascularization. The median age of the total collective was 66 (50-90) years. We did not find difference in our analysis of RA Volume (p 0.086), RA area (p 0.093), RA major dimension (p 0.32) and RA minor dimension (p 0.139) at baseline and follow-up. Mean RA reservoir strain at baseline was 30.9% (21.1-43.0) vs. 33.4% (20.7-47.7) at follow up (p < 0.001). Mean RA conduit strain was - 17.5% (- 10.7-(- 29.7)) at baseline vs. - 18.2% (- 9.6-(- 31.7)) at follow-up (p = 0.346). Mean RA contraction strain was - 12.9% (- 8.0- (- 21.3)) at baseline vs. - 15.5% (- 8.7-(- 26.6)) at follow-up (p < 0.001). CONCLUSION: Right atrial function was altered in patients with RCA CTO. Successful revascularisation of an RCA CTO improved RA function assessed by strain imaging at follow-up.


Asunto(s)
Oclusión Coronaria , Intervención Coronaria Percutánea , Humanos , Anciano , Anciano de 80 o más Años , Función del Atrio Derecho , Enfermedad Crónica , Oclusión Coronaria/diagnóstico por imagen , Oclusión Coronaria/terapia , Ecocardiografía , Vasos Coronarios , Intervención Coronaria Percutánea/efectos adversos , Resultado del Tratamiento
15.
Scand Cardiovasc J ; 57(1): 2161621, 2023 12.
Artículo en Inglés | MEDLINE | ID: mdl-36587829

RESUMEN

Objectives. To compare long-term angina pectoris relief of successful versus failed percutaneous coronary intervention of chronic total occlusions (CTO PCI). Background. Previous studies demonstrate better short-term angina pectoris relief of CTO PCI than with optimal medical treatment (OMT), however, data on the long-term effects are lacking. Methods. 295 patients undergoing CTO PCI were analyzed retrospectively, with a follow-up evaluation of symptoms of angina pectoris and all-cause death one to four years after the intervention. The primary outcome was long-term relief of symptoms of angina pectoris. Secondary outcomes included a composite of major adverse cardiovascular events (MACE), including all-cause death, myocardial infarction, stroke, and later target vessel revascularization (TVR). At follow-up, patients were interviewed for symptoms of angina pectoris at 1, 6, 12, and 22 to 48 months after the intervention. Results. CTO PCI was successful in 225 (76%) patients and failed in 70 (24%) patients. Short-term (six months) relief of angina pectoris was observed in both groups, but only the successful CTO PCI group showed long-term relief. The Kaplan-Meier curves of all-cause death did not differ between the groups (p = .715). The final follow-up was a mean (range) of 37 (25 to 44) months after the intervention in the successful CTO PCI group, and 33 (28 to 48) months in the failed CTO PCI group. Conclusions. Successful CTO PCI is associated with better long-term relief of symptoms of angina pectoris compared to failed CTO PCI.


Asunto(s)
Oclusión Coronaria , Intervención Coronaria Percutánea , Humanos , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/métodos , Vasos Coronarios , Estudios Retrospectivos , Oclusión Coronaria/diagnóstico por imagen , Oclusión Coronaria/terapia , Angina de Pecho/diagnóstico por imagen , Angina de Pecho/terapia , Enfermedad Crónica , Resultado del Tratamiento , Factores de Riesgo
16.
Eur Heart J Suppl ; 25(Suppl B): B149-B154, 2023 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-37091662

RESUMEN

The decision whether or not to recanalize a chronic total occlusion (CTO) of a coronary artery is truly a dilemma for the cardiologist. The procedure is in fact complex, with a non-negligible rate of complications and with a probability of success lower than that of non-obstructive lesions. The analysis of the data available in the literature, with the significant discrepancy between the results of the randomized studies and the observational studies, does not currently allow conclusive statements on the role of the percutaneous coronary interventions in CTO. It is therefore essential to incorporate clinical, anatomical and procedural elements into the decision-making algorithm. While awaiting new randomized clinical trials of greater dimensions and better methodology, a careful selection of patients is certainly essential, limiting the procedure to those who are symptomatic or who have a high ischaemic burden and excluding those who have no evidence of vitality, without which it is not legitimate to expect any benefit from the intervention. Finally, the presence of the collateral circulation does not in itself appear to be an element that should have a significant decision-making role.

17.
Adv Exp Med Biol ; 1430: 91-116, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-37526844

RESUMEN

Health Canada regulates gene therapy products and many cell therapy products as biological drugs under the Canadian Food and Drugs Act and its attendant regulations. Cellular products that meet certain criteria, including minimal manipulation and homologous use, may be subjected to a standards-based approach under the Safety of Human Cells, Tissues and Organs for Transplantation Regulations. The manufacture and clinical testing of cell and gene therapy products (CGTP) presents many challenges beyond those for protein biologics. Cells cannot be subjected to pathogen removal or inactivation procedures and must frequently be administered shortly after final formulation. Viral vector design and manufacturing control are critically important to overall product quality and linked to safety and efficacy in patients through concerns such as replication competence, vector integration, and vector shedding. In addition, for many CGTP, the value of nonclinical studies is largely limited to providing proof of concept, and the first meaningful data relating to appropriate dosing, safety parameters, and validity of surrogate or true determinants of efficacy must come from carefully designed clinical trials in patients. Addressing these numerous challenges requires application of various risk mitigation strategies and meeting regulatory expectations specifically adapted to the product types. Regulatory cooperation and harmonization at an international level are essential for progress in the development and commercialization of these products. However, particularly in the area of cell therapy, new regulatory paradigms may be needed to harness the benefits of clinical progress in situations where the resources and motivation to pursue a typical drug product approval pathway may be lacking. This chapter is dedicated to provide an overview of Health Canada regulatory oversight of CGTP.


Asunto(s)
Tratamiento Basado en Trasplante de Células y Tejidos , Terapia Genética , Humanos , Canadá , Tratamiento Basado en Trasplante de Células y Tejidos/efectos adversos , Comercio , Terapia Genética/efectos adversos , Vectores Genéticos
18.
Vasa ; 52(3): 147-159, 2023 May.
Artículo en Inglés | MEDLINE | ID: mdl-36924047

RESUMEN

Together with colleagues from different disciplines, including cardiologists, interventional radiologists and vascular surgeons, committee members of the of the German Society of Angiology (Deutsche Gesellschaft für Angiologie [DGA]), developed a novel algorithm for the endovascular treatment of peripheral chronic total occlusive lesions (CTOs). Our aim is to improve patient and limb related outcomes, by increasing the success rate of endovascular procedures. This can be achieved by adherence to the proposed crossing algorithm, aiding the standardization of endovascular procedures. The following steps are proposed: (i) APPLY Duplex sonography and if required 3D techniques such as computed tomography or magnetic resonance angiography. This will help you to select the optimal access site. (ii) EVALUATE the CTO cap morphology and distal vessel refilling sites during diagnostic angiography, which are potential targets for a retrograde access. (iii) START with antegrade wiring strategies including guidewire (GW) and support catheter technology. Use GW escalation strategies to penetrate the proximal cap of the CTO, which may usually be fibrotic and calcified. (iv) STOP the antegrade attempt depending on patient specific parameters and the presence of retrograde options, as evaluated by pre-procedural imaging and during angiography. (v) In case of FAILURE, consider advanced bidirectional techniques and reentry devices. (vi) In case of SUCCESS, externalize the GW and treat the CTO. Manage the retrograde access at the end of the endovascular procedure. (vii) STOP the procedure if no progress can be obtained within 3 hours, in case of specific complications or when reaching maximum contrast administration based on individual patient's renal function. Consider radiation exposure both for patients and operators. In this manuscript we systematically follow and explain each of the steps (i)-(vi) based on practical examples from our daily routine. We strongly believe that the integration of this algorithm in the daily practice of endovascular specialists, can improve vessel and patient specific outcomes.


Asunto(s)
Procedimientos Endovasculares , Enfermedad Arterial Periférica , Humanos , Enfermedad Arterial Periférica/diagnóstico por imagen , Enfermedad Arterial Periférica/terapia , Procedimientos Endovasculares/efectos adversos , Angiografía , Cateterismo , Resultado del Tratamiento , Enfermedad Crónica
19.
Catheter Cardiovasc Interv ; 99(4): 1065-1073, 2022 03.
Artículo en Inglés | MEDLINE | ID: mdl-35077606

RESUMEN

BACKGROUND: Chronic total occlusions (CTO) are common and are associated with lower percutaneous coronary intervention (PCI) success rates, often due to failure of antegrade guidewire crossing. Local, intralesional delivery of collagenase (MZ-004) may facilitate guidewire crossing in CTO. AIMS: To evaluate the effect of MZ-004 in facilitating antegrade wire crossing in CTO angioplasty. METHODS: A total of 76 patients undergoing CTO PCI were enrolled at 13 international sites: 38 in the randomized training stage (collagenase [MZ-004] 900 or 1200 µg) and 38 in the placebo-controlled stage (MZ-004 900 or 1200 µg or placebo). Patients received the MZ-004 or identical volume saline (placebo group) in a double-blind design, injected via microcatheter directly into the proximal cap of the CTO. The following day patients underwent CTO PCI using antegrade wire techniques only. RESULTS: Patients were generally similar except for a trend for higher Japanese chronic total occlusion (J-CTO) score in the MZ-004 group (MZ-004 J-CTO score 1.9 vs. 1.4, p = 0.07). There was a numerical increase in the rates of guidewire crossing in the MZ-004 groups compared to placebo (74% vs. 63%, p = 0.52). Guidewire crossing with a soft-tip guidewire (≤1.5 g tip load) was significantly higher in the MZ-004 groups (0% in placebo, 17% in 900 µg, and 29% in 1200 µg MZ-004 group, p = 0.03). Rates of the major adverse cardiovascular event were similar between groups. CONCLUSION: Local delivery of MZ-004 into coronary CTOs appears safe and may facilitate CTO crossing, particularly with softer tipped guidewires. These data support the development of a pivotal trial to further evaluate this agent.


Asunto(s)
Oclusión Coronaria , Intervención Coronaria Percutánea , Enfermedad Crónica , Colagenasas , Angiografía Coronaria/métodos , Oclusión Coronaria/cirugía , Oclusión Coronaria/terapia , Vasos Coronarios , Humanos , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/métodos , Resultado del Tratamiento
20.
Catheter Cardiovasc Interv ; 100(4): 502-511, 2022 10.
Artículo en Inglés | MEDLINE | ID: mdl-35900200

RESUMEN

INTRODUCTION: The minimalistic hybrid approach (MHA) is an algorithm to perform chronic total occlusion (CTO) percutaneous coronary intervention (PCI). The current study aims to evaluate the distribution of patients among the five different treatment strategies, the different techniques used in each strategy, the overall procedural success, and the safety of the MHA algorithm. METHODS: Data from a consecutive series of patients with a CTO who underwent elective PCI between February 2019 and July 2021 were prospectively collected and retrospectively analyzed. RESULTS: One hundred and forty-three CTOPCI in 135 patients were approached according to the MHA algorithm: 134 CTO (93.7%) were successfully recanalized and 9 procedures failed. About half of the procedures (48.3%) were approached using strategy A: antegrade "blind wiring" with contralateral retrograde options, making this the most popular strategy. A total of 89 procedures (62.2%) were completed with a single guiding catheter; in 86 (96.6%) a forearm approach was used. The remaining 54 cases were performed with dual access; in the majority of these patients (90.7%), a bilateral forearm approach was used. The only reason to use the femoral access was inadequate forearm access. One hundred and fifty-four out of 197 (78.2%) access sites were 6 French sheaths. CONCLUSION: MHA is a stepwise approach focused on the forearm approach to reduce the number of access sites and catheter size used in CTOPCI while maintaining proficiency and safety. Operators should be warned that this approach should be adopted only by experienced CTO operators who master all the strategies of the classic hybrid algorithm and the forearm approach.


Asunto(s)
Oclusión Coronaria , Intervención Coronaria Percutánea , Algoritmos , Enfermedad Crónica , Angiografía Coronaria , Oclusión Coronaria/diagnóstico por imagen , Oclusión Coronaria/terapia , Humanos , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/métodos , Sistema de Registros , Estudios Retrospectivos , Factores de Riesgo , Resultado del Tratamiento
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