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1.
Thorax ; 79(7): 633-643, 2024 Jun 14.
Artículo en Inglés | MEDLINE | ID: mdl-38242710

RESUMEN

BACKGROUND: Transbronchial cryoablation shows potential as a local therapy for inoperable peripheral lung cancer. However, its clinical application for peripheral pulmonary lesions has not been reported yet. METHODS: An improved cryoprobe with an 8-mm-long, 1.9-mm-wide cryotip was used. Initially, the safety and effectiveness of this cryoprobe were assessed in an in vivo porcine model. Transbronchial cryoablation with 2 or 3 freeze-thaw cycles (10 min or 15 min in each freezing time) was performed in 18 pigs under CT monitoring. Radiological and pathological examinations were performed to evaluate the extent of cryoablation. Subsequently, nine patients with stage IA peripheral lung cancer or metastases underwent transbronchial cryoablation with this cryoprobe under the guidance of navigation bronchoscopy and cone-beam CT. Technical success, safety and outcomes were assessed. RESULTS: 36 cryoablation procedures were performed successfully without any major complications in the porcine model. The extent of cryoablation increased with freezing time and the number of freeze-thaw cycles, which peaked at 24 hours and then gradually decreased. Pathological results showed a change from massive haemorrhage at 24 hours to fibrous hyperplasia with chronic inflammation after 4 weeks. In the clinical trial, 10 cryoablations were performed on 9 tumours with a technical success rate of 100%. One mild treatment-related complication occurred. Of the nine tumours, seven achieved complete ablation, while two exhibited incomplete ablation and subsequent local progression at 6 months. CONCLUSION: Our initial experience indicated that transbronchial cryoablation was a safe and feasible procedure for non-surgical peripheral stage IA lung cancer or pulmonary metastases. TRIAL REGISTRATION NUMBER: ChiCTR2200061544.


Asunto(s)
Broncoscopía , Criocirugía , Neoplasias Pulmonares , Criocirugía/métodos , Criocirugía/instrumentación , Animales , Neoplasias Pulmonares/cirugía , Neoplasias Pulmonares/patología , Porcinos , Humanos , Broncoscopía/métodos , Masculino , Femenino , Anciano , Persona de Mediana Edad , Resultado del Tratamiento , Tomografía Computarizada de Haz Cónico
2.
J Cardiovasc Electrophysiol ; 35(6): 1095-1100, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38511484

RESUMEN

INTRODUCTION: In cryoballoon ablation (CBA) procedures, transseptal access (TSA) is generally achieved using a standard sheath and needle system that is exchanged for the cryoballoon delivery sheath and dilator over a long wire. Sheath exchange has been related with air embolic events. Recently, an integrated dilator-needle system assembled to the cryoballoon sheath was introduced. We aimed to evaluate the efficacy and safety of an integrated TSA tool compared with the traditional approach in atrial fibrillation CBA procedures. METHODS: Patients scheduled for CBA procedures were randomized 1:1 to traditional TSA (t-TSA) or integrated TSA (i-TSA). TSA time was defined as time from superior vena cava to LA insertion of the cryoballoon delivery sheath, after sheath exchange (t-TSA) or directly (i-TSA). RESULTS: Ninety-seven patients (76 males, mean age 59 ± 10 years) were randomized, 48 patients underwent t-TSA, and 49 i-TSA. Mean TSA time was 5 min 59 s ± 5 min 36 s in the t-TSA group and 2 min 59 s ± 2 min 14 s in the i-TSA group (p < .001). Total fluoroscopy time, skin-to-skin procedure time, and LA dwell time were respectively 15 ± 6, 69 ± 16, and 44 ± 12 min in the t-TSA group and 13 ± 6, 65 ± 15, and 43 ± 11 min in the i-TSA group (p = ns). No clinically significant acute complications related to TSA were noted in both cohorts. CONCLUSION: This is the first randomized study comparing both TSA approaches. TSA in CBA procedures using this integrated tool enables a safe and efficient workflow, reducing TSA time and avoiding sheath exchange.


Asunto(s)
Fibrilación Atrial , Criocirugía , Diseño de Equipo , Humanos , Fibrilación Atrial/cirugía , Fibrilación Atrial/fisiopatología , Fibrilación Atrial/diagnóstico , Criocirugía/instrumentación , Criocirugía/efectos adversos , Masculino , Femenino , Persona de Mediana Edad , Anciano , Resultado del Tratamiento , Factores de Tiempo , Catéteres Cardíacos , Tempo Operativo , Agujas , Venas Pulmonares/cirugía , Venas Pulmonares/fisiopatología , Estudios Prospectivos , Frecuencia Cardíaca , Potenciales de Acción
3.
J Cardiovasc Electrophysiol ; 35(8): 1624-1632, 2024 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-38898656

RESUMEN

INTRODUCTION: A hybrid convergent approach (endocardial and epicardial ablation) demonstrated superior effectiveness in a recent randomized study for long-standing persistent atrial fibrillation (LSPAF). Yet, there is a lack of real-world, long-term evidence as to which patients are best candidates for a hybrid convergent approach compared to standard endocardial cryoballoon pulmonary vein isolation (CB PVI). METHODS AND RESULTS: This single-center, retrospective analysis spanning from 2010 to 2015 compared two distinctly different atrial fibrillation (AF) cohorts; one treated with stand-alone cryoablation and one treated with a hybrid convergent approach. Baseline characteristics described candidates for each approach. The following criteria were utilized to determine CB PVI candidacy: (1) paroxysmal AF (PAF) (stage 3A) with failed class I/III antiarrhythmic drug (AAD) or (2) persistent/LSPAF (stage 3B/3C/3D) with failed class I/III AAD unwilling to undergo hybrid procedure. Selection criteria for the hybrid procedure included: (1) PAF refractory to both class I/III AAD and prior CB PVI (stage 3D) or (2) persistent/LSPAF (stage 3B/3C/3D) with failed class I/III AAD agreeable to hybrid procedure. Prior sternotomy was excluded. Serial electrocardiograms and continuous monitoring evaluated primary efficacy outcome of time-to-first recurrence of atrial arrhythmia after a 90-day blanking period. Secondary outcomes were procedure-related complications and AAD use (at discharge, 12, and 36 months). Kaplan-Meier methods evaluated arrhythmia recurrence. Of 276 patients, 197 (64.2 ± 10.6 years old; 66.5% male; 74.1% 3A-PAF; 18.3% 3B/3D-persistent AF; 1.0% 3C-LSPAF; 6.6% undetermined) underwent CB PVI and 79 (61.4 ± 8.1 years old; 83.5% male; 41.8% 3D-PAF; 45.5% 3B/3D-persistent AF; 12.7% 3C/3D-LSPAF) underwent hybrid procedure. Arrhythmia freedom through 36 months was 55.2% for CB PVI and 50.4% for hybrid (p = .32). Class I AAD utilization at discharge occurred in 38 (19.3%) patients in the CB PVI group and 5 (6.3%) patients in the hybrid group (p = .01). CB PVI class I AAD utilization at 12 months occurred in 14 (9.0) patients versus 0 patients for hybrid convergent (p = .004). Patients with one or more adverse event were as follows: two (1.0%) in the CB PVI group (both transient phrenic nerve palsy) and three (3.7%) in the hybrid group (two with significant bleeding and one with wound infection) (p = .14). CONCLUSION: This study demonstrated that patients with more complex forms of AF (3D-PAF or 3B/3C/3D-persistent/LSPAF) could be well managed with a convergent approach. In a real-world evaluation, outcomes match safety and efficacy thresholds achieved for patients with earlier, less complex AF etiologies treated by CB PVI alone.


Asunto(s)
Potenciales de Acción , Fibrilación Atrial , Criocirugía , Venas Pulmonares , Recurrencia , Humanos , Fibrilación Atrial/cirugía , Fibrilación Atrial/fisiopatología , Fibrilación Atrial/diagnóstico , Criocirugía/efectos adversos , Criocirugía/instrumentación , Masculino , Femenino , Estudios Retrospectivos , Persona de Mediana Edad , Factores de Tiempo , Anciano , Venas Pulmonares/cirugía , Venas Pulmonares/fisiopatología , Factores de Riesgo , Resultado del Tratamiento , Frecuencia Cardíaca , Toma de Decisiones Clínicas , Supervivencia sin Progresión
4.
J Cardiovasc Electrophysiol ; 35(6): 1129-1139, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38556747

RESUMEN

INTRODUCTION: Recent studies have reported the efficacy of the cryoballoon (CB)-guided left atrial roof block line (LARB) creation in patients with persistent atrial fibrillation (AF). However, it can be technically challenging to attach the balloon to the left atrial (LA) roof due to its anatomical variations. We designed a new procedure called the "Raise-up Technique," which may facilitate the firm adhesion of the CB to the LA roof during freezing. This study aimed to evaluate the efficacy of the Raise-up technique in LARB creation. METHODS AND RESULTS: In total, 100 consecutive patients with persistent AF who underwent CB-LARB creation were enrolled. Fifty-seven patients underwent LARB creation using the Raise-up technique (Raise-up group), and the remaining 43 did not use it (control group). The Raise-up technique was performed as follows: An Achieve catheter was inserted as deeply as possible into the upper branch of the right superior pulmonary vein to anchor the CB. The balloon was placed below the targeted site on the LA roof and frozen. When the temperature of the CB reached approximately -10°C and the CB was easier to attach to the LA tissue, the CB was raised and pressed against the LA roof immediately by sheath advancement. Then the balloon could be in firm contact with the target site on the roof. If necessary, additional sheath advancement after sufficient freezing (-20°C to -30°C) was allowed the CB to have more firm and broad contact with the target site. LARB creation without touch-up ablation was achieved in 54 of 57 patients (94.7%) in the Raise-up group and 33 of 43 patients (76.7%) in the control group (p < .05). The lesion size of the LARB in the Raise-up group was significantly larger than that in the control group (15.2 cm2 vs. 12.8 cm2, p < .05). Moreover, the width of the LARB lesion in the Raise-up group was wider than that in the control group (32.0 mm vs. 26.6 mm, p < .05). CONCLUSION: The Raise-up technique enabled the creation of seamless and thick LARB lesions with a single stroke. In addition, the CB-LARB lesions created using the Raise-up technique tended to be large, resulting in extensive debulking of the LA posterior wall arrhythmia substrates. In CB ablation for persistent AF, the Raise-up technique can be considered one of the key strategies for LARB creation.


Asunto(s)
Fibrilación Atrial , Criocirugía , Humanos , Fibrilación Atrial/cirugía , Fibrilación Atrial/fisiopatología , Fibrilación Atrial/diagnóstico , Criocirugía/instrumentación , Femenino , Masculino , Persona de Mediana Edad , Anciano , Resultado del Tratamiento , Atrios Cardíacos/cirugía , Atrios Cardíacos/fisiopatología , Atrios Cardíacos/diagnóstico por imagen , Potenciales de Acción , Frecuencia Cardíaca , Factores de Tiempo , Estudios Retrospectivos , Recurrencia , Venas Pulmonares/cirugía , Venas Pulmonares/fisiopatología
5.
J Vasc Interv Radiol ; 35(7): 1022-1030.e4, 2024 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-38599280

RESUMEN

PURPOSE: To evaluate the performance of a prototype flexible transbronchial cryoprobe compared with that of percutaneous transthoracic cryoablation and to define cone-beam computed tomography (CT) imaging and pathology cryolesion features in an in vivo swine model. MATERIALS AND METHODS: Transbronchial cryoablation was performed with a prototype flexible cryoprobe (3 central and 3 peripheral lung ablations in 3 swine) and compared with transthoracic cryoablation performed with a commercially available rigid cryoprobe (2 peripheral lung ablations in 1 swine). Procedural time and cryoablation success rates for endobronchial navigation and cryoneedle deployment were measured. Intraoperative cone-beam CT imaging features of cryolesions were characterized and correlated with gross pathology and hematoxylin and eosin-stained sections of the explanted cryolesions. RESULTS: The flexible cryoprobe was successfully navigated and delivered to each target through a steerable guiding sheath (6/6). At 4 minutes after ablation, 5 of 6 transbronchial and 2 of 2 transthoracic cryolesions were visible on cone-beam CT. The volumes on cone-beam CT images were 55.5 cm3 (SE ± 8.0) for central transbronchial ablations (n = 2), 72.5 cm3 (SE ± 8.1) for peripheral transbronchial ablations (n = 3), and 79.5 cm3 (SE ±11.6) for peripheral transthoracic ablations (n = 2). Pneumothorax developed in 1 animal after transbronchial ablation and during ablation in the transthoracic cryoablation. Images of cryoablation zones on cone-beam CT correlated well with the matched gross pathology and histopathology sections of the cryolesions. CONCLUSIONS: Transbronchial cryoablation with a flexible cryoprobe, delivered through a steerable guiding sheath, is feasible. Transbronchial cryoablation zones are imageable with cone-beam CT, with gross pathology and histopathology similar to those of transthoracic cryoablation.


Asunto(s)
Tomografía Computarizada de Haz Cónico , Criocirugía , Diseño de Equipo , Animales , Criocirugía/instrumentación , Tomografía Computarizada de Haz Cónico/instrumentación , Porcinos , Radiografía Intervencional/instrumentación , Pulmón/cirugía , Pulmón/diagnóstico por imagen , Pulmón/patología , Modelos Animales , Broncoscopía/instrumentación , Sus scrofa
6.
Europace ; 26(5)2024 May 02.
Artículo en Inglés | MEDLINE | ID: mdl-38637325

RESUMEN

AIMS: Left atrial appendage electrical isolation (LAAEI) has demonstrated a significant enhancement in the success rate of atrial fibrillation (AF) ablation. Nevertheless, concerns persist about the safety of LAAEI, particularly regarding alterations in left atrial appendage (LAA) flow velocity and the potential risks of thrombus. This study aimed to assess the efficacy and safety of LAAEI, investigating changes in LAA flow velocity in canines. METHODS AND RESULTS: The study comprised a total of 10 canines. The LAAEI procedure used by a 23 mm cryoballoon of the second generation was conducted at least 180 s. Intracardiac ultrasonography (ICE) was employed to quantify the velocity flow of the LAA both prior to and following LAAEI. Following a 3-month period, subsequent evaluations were performed to assess the LAA velocity flow and the potential reconnection. Histopathological examination was conducted. Left atrial appendage electrical isolation was effectively accomplished in all canines, resulting in a 100% acute success rate (10/10). The flow velocity in the LAA showed a notable reduction during LAAEI as compared with the values before the ablation procedure (53.12 ± 5.89 vs. 42.01 ± 9.22 cm/s, P = 0.007). After the follow-up, reconnection was observed in four canines, leading to a success rate of LAAEI of 60% (6/10). The flow velocity in the LAA was consistently lower (53.12 ± 5.89 vs. 44.33 ± 10.49 cm/s, P = 0.006), and no blood clot development was observed. The histopathological study indicated that there was consistent and complete injury to the LAA, affecting all layers of its wall. The injured tissue was subsequently replaced by fibrous tissue. CONCLUSION: The feasibility of using cryoballoon ablation for LAAEI was confirmed in canines, leading to a significant reduction of LAA flow velocity after ablation. Some restoration of LAA flow velocity after ablation may be linked to the passive movement of the LAA and potential reconnecting. However, this conclusion is limited to animal study; more clinical data are needed to further illustrate the safety and accessibility of LAAEI in humans.


Asunto(s)
Apéndice Atrial , Fibrilación Atrial , Criocirugía , Perros , Animales , Apéndice Atrial/cirugía , Criocirugía/métodos , Criocirugía/efectos adversos , Criocirugía/instrumentación , Fibrilación Atrial/cirugía , Fibrilación Atrial/fisiopatología , Fibrilación Atrial/diagnóstico , Diseño de Equipo , Velocidad del Flujo Sanguíneo , Resultado del Tratamiento , Masculino
7.
Europace ; 26(5)2024 May 02.
Artículo en Inglés | MEDLINE | ID: mdl-38767127

RESUMEN

AIMS: Understanding of the tissue cooling properties of cryoballoon ablation during pulmonary vein (PV) isolation is lacking. The purpose of this study was to delineate the depth of the tissue cooling effect during cryoballoon freezing at the pulmonary venous ostium. METHODS AND RESULTS: A left atrial-PV model was constructed using a three-dimensional printer with data from a patient to which porcine thigh muscle of various thicknesses could be affixed. The model was placed in a 37°C water tank with a PV water flow at a rate that mimicked biological blood flow. Cryofreezing at the PV ostium was performed five times each for sliced porcine thigh muscle of 2, 4, and 6 mm thickness, and sliced muscle cooling on the side opposite the balloon was monitored. The cooling effect was assessed using the average temperature of 12 evenly distributed thermocouples covering the roof region of the left superior PV. Tissue cooling effects were in the order of the 2, 4, and 6 mm thicknesses, with an average temperature of -41.4 ± 4.2°C for 2 mm, -33.0 ± 4.0°C for 4 mm, and 8.0 ± 8.7°C for 6 mm at 180 s (P for trend <0.0001). In addition, tissue temperature drops were steeper in thin muscle (maximum temperature drop per 5 s: 5.2 ± 0.9°C, 3.9 ± 0.7°C, and 1.3 ± 0.7°C, P for trend <0.0001). CONCLUSION: The cooling effect of cryoballoon freezing is weaker in the deeper layers. Cryoballoon ablation should be performed with consideration to myocardial thickness.


Asunto(s)
Criocirugía , Venas Pulmonares , Criocirugía/métodos , Criocirugía/instrumentación , Criocirugía/efectos adversos , Animales , Venas Pulmonares/cirugía , Venas Pulmonares/fisiopatología , Porcinos , Fibrilación Atrial/cirugía , Fibrilación Atrial/fisiopatología , Humanos , Modelos Cardiovasculares , Músculo Esquelético/cirugía , Modelos Anatómicos
8.
Respiration ; 103(5): 268-274, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38471486

RESUMEN

INTRODUCTION: Today, the increasing number of incidentally detected peripheral pulmonary lesions (PPLs) within and outside lung cancer screening trials is a diagnostic challenge. This fact encourages further improvement of diagnostic procedures to increase the diagnostic yield of transbronchial biopsy, which has been shown to have a low complication rate. The purpose of this study was to evaluate the safety and feasibility of a new ultrathin 1.1 cryoprobe that can be placed through an ultrathin bronchoscope (UTB) using fluoroscopy and radial endobronchial ultrasonography (rEBUS) navigation for assessing PPLs. METHODS: Thirty-five patients with PPL less than 4 cm in diameter were prospectively enrolled to receive transbronchial cryobiopsies (TBCBs) using the ultrathin 1.1-mm cryoprobe. Navigation to the PPL was accomplished with the UTB. Under rEBUS and fluoroscopy guidance up to 4 cryobiopsies were obtained. The sample sizes of the biopsies were compared to a historic collective derived from a 1.9-mm cryoprobe and standard forceps. The feasibility and safety of the procedure, the cumulative and overall diagnostic yield, and the cryobiopsy sizes were evaluated. RESULTS: After detection with the rEBUS, TBCB was collected from 35 PPLs, establishing a diagnosis in 25 cases, corresponding to an overall diagnostic yield of 71.4%. There was no difference in diagnostic yield for PPL <20 mm or ≥20 mm. All cryobiopsies were representative with a mean tissue area of 11.9 ± 4.3 mm2, which was significantly larger compared to the historic collective (p = 0.003). Six mild and four moderate bleeding events and 1 case of pneumothorax were observed. CONCLUSIONS: Using the ultrathin 1.1-mm cryoprobe combined with an UTB for rEBUS-guided TBCB of PPL is feasible and safe. This diagnostic approach improves bronchoscopic techniques for diagnosing peripheral lung lesions and may contribute to improve diagnosis of lung cancer even in small PPL.


Asunto(s)
Broncoscopía , Criocirugía , Endosonografía , Estudios de Factibilidad , Neoplasias Pulmonares , Humanos , Broncoscopía/métodos , Broncoscopía/instrumentación , Masculino , Femenino , Anciano , Persona de Mediana Edad , Criocirugía/métodos , Criocirugía/instrumentación , Neoplasias Pulmonares/patología , Neoplasias Pulmonares/diagnóstico por imagen , Neoplasias Pulmonares/diagnóstico , Estudios Prospectivos , Endosonografía/métodos , Endosonografía/instrumentación , Fluoroscopía/métodos , Biopsia Guiada por Imagen/métodos , Biopsia Guiada por Imagen/instrumentación , Ultrasonografía Intervencional/métodos , Ultrasonografía Intervencional/instrumentación , Biopsia/métodos , Biopsia/instrumentación , Anciano de 80 o más Años
9.
Lasers Med Sci ; 39(1): 209, 2024 Aug 05.
Artículo en Inglés | MEDLINE | ID: mdl-39101963

RESUMEN

Cold knife urethrotome was introduced in 1971 and it had an 80% success rate. New advancements in this field have shed light on the use of various lasers such as carbon dioxide, Nd: YAG, KTP, Argon, Ho: YAG, and excimer lasers. It has been observed that cold knife urethrotomy has a higher recurrence rate than laser urethrotomy, but the superiority of either treatment modality has not been established yet. Data were thoroughly searched through PubMed, Scopus, and clinicaltrials.gov. We also used clinicaltrials.gov for ongoing and published research. The data was analyzed via R studio version 2023.12.1 (oceanstorm). For dichotomous variables, Odds Ratio (OR) were used to pool data and standardized mean difference was used for continuous variables with 95% confidence intervals (CIs). A total of 14 studies including 1114 participants were included in this meta-analysis. The results of the combined analysis revealed significant relation with a mean difference of 0.99 (95% CI: 0.37; 1.62), and favored laser group. The overall results have shown the laser to have a significant favorable profile demonstrating a recurrence, Odds Ratio of 0.42 (95% CI:0.27;0.65). Patients with laser therapy had a lower risk of complication rate (OR 0.49, 95% Cl: 0.35; 0.67). All the findings obtained by the analysis in this study favour lasers significantly over the cold knife technique especially when mean Qmax, with recurrence and complications taken into account.


Asunto(s)
Uretra , Humanos , Uretra/cirugía , Terapia por Láser/métodos , Terapia por Láser/instrumentación , Terapia por Láser/efectos adversos , Resultado del Tratamiento , Estrechez Uretral/cirugía , Recurrencia , Masculino , Criocirugía/métodos , Criocirugía/instrumentación , Criocirugía/efectos adversos
10.
Sci Rep ; 14(1): 18653, 2024 08 12.
Artículo en Inglés | MEDLINE | ID: mdl-39134712

RESUMEN

EBUS-guided transbronchial mediastinal cryobiopsy (TBMC) has emerged as a promising biopsy tool for diagnosing hilar and mediastinal pathologies. However, several fundamental technical aspects of TBMC remain unexplored. This study aims to determine the optimal number of cryo-passes and freezing time of the ultrathin cryoprobe in EBUS-TBMC concerning specimen size and procedural diagnostic yield. We conducted a retrospective chart review of patients with mediastinal and hilar lesions who underwent EBUS-TBMC between January 2021 and April 2023 across three hospitals in Malaysia. A total of 129 EBUS-TBMC procedures were successfully completed, achieving an overall diagnostic yield of 88.4%. Conclusive TBMC procedures were associated with larger specimen sizes (7.0 vs. 5.0 mm, p < 0.01). Specimen size demonstrated a positive correlation with diagnostic yield (p < 0.01), plateauing at specimen size of 4.1-6.0 mm. A significant positive correlation was also observed between the number of cryo-passes and both specimen size (p < 0.01) and diagnostic yield (p < 0.05). Diagnostic yield plateaued after 2-3 cryo-passes. In contrast, longer freezing times trended towards smaller specimens and lower diagnostic yield, though not reaching statistical significance. The highest diagnostic yield was recorded at the 3.1-4.0 s freezing time. The safety profile of TBMC remains favourable, with one case (0.8%) of pneumothorax and nine cases (7%) of self-limiting bleeding. In our cohort, TBMC performance with 2-3 cryo-passes and a 3.1-4.0 s freezing time to achieve a total aggregate specimen size of 4.1-6.0 mm appeared optimal. Further prospective studies are needed to validate these findings.


Asunto(s)
Criocirugía , Congelación , Humanos , Masculino , Femenino , Persona de Mediana Edad , Estudios Retrospectivos , Anciano , Criocirugía/métodos , Criocirugía/instrumentación , Mediastino/patología , Adulto , Broncoscopía/métodos , Broncoscopía/instrumentación
11.
JACC Clin Electrophysiol ; 10(7 Pt 1): 1367-1376, 2024 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-38752963

RESUMEN

BACKGROUND: Pulmonary vein isolation is an effective treatment for atrial fibrillation (AF). Cryoballoon ablation using the Arctic Front cryoballoon (Medtronic) was found to be superior to antiarrhythmic drug treatment. Recently, a novel cryoballoon system was introduced (PolarX, Boston Scientific). OBJECTIVES: The purpose of this study was to compare the efficacy and safety of the 2 cryoballoons in a randomized controlled trial. METHODS: Patients with symptomatic paroxysmal AF were enrolled in 2 centers and randomized 1:1 to pulmonary vein isolation using the PolarX or the Arctic Front cryoballoon. All patients received an implantable cardiac monitor. The primary endpoint was first recurrence of atrial tachyarrhythmia (AF, atrial flutter, or atrial tachycardia [AT]) between days 91 and 365. Procedural safety was assessed by a composite of tamponade, phrenic nerve palsy lasting >24 hours, vascular complications, stroke/transient ischemic attack, atrioesophageal fistula or death up to 30 days. RESULTS: A total of 201 patients were enrolled. At 1 year, recurrence of atrial tachyarrhythmia had occurred in 41 of 99 patients (41.6%) assigned to the PolarX group and in 48 of 102 patients (47.1%) assigned to the Arctic Front group (HR: 0.85 [95% CI: 0.56-1.30]; P = 0.03 for noninferiority; P = 0.46 for superiority). The safety endpoint occurred in 5 patients (5%) in the PolarX group (n = 5 phrenic nerve palsies lasting >24 hours), whereas no safety endpoints occurred in the Arctic Front group (P = 0.03). CONCLUSIONS: In this randomized controlled trial using implantable cardiac monitors for continuous rhythm monitoring, the novel PolarX cryoballoon was noninferior compared with the Arctic Front cryoballoon regarding efficacy. However, the PolarX balloon resulted in significantly more phrenic nerve palsies. (Comparison of PolarX and the Arctic Front Cryoballoons for PVI in Patients With Symptomatic Paroxysmal AF [COMPARE-CRYO]; NCT04704986).


Asunto(s)
Fibrilación Atrial , Criocirugía , Venas Pulmonares , Humanos , Fibrilación Atrial/cirugía , Masculino , Femenino , Criocirugía/métodos , Criocirugía/instrumentación , Persona de Mediana Edad , Anciano , Venas Pulmonares/cirugía , Resultado del Tratamiento , Recurrencia , Nervio Frénico/lesiones
12.
Respir Investig ; 62(4): 732-737, 2024 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-38878626

RESUMEN

BACKGROUND: Cryobiopsy use is anticipated to become more common in diagnosing lung diseases. In Japan, inserting a Fogarty catheter through a suction channel above the endotracheal tube's cuff for hemostasis is common practice. However, the rigid nature of the endotracheal tube poses challenges to tracheal intubation using a bronchoscope. The endotracheal tube cuff must be removed to prevent interference during Fogarty catheter insertion. To simplify the procedure and enhance safety, we devised and implemented a method of inserting a hemostatic Fogarty catheter with a suction tube externally attached to a softer endotracheal tube. This study aimed to evaluate the sustainability of this Fogarty catheter insertion method using suction tubes. METHODS: The hemostatic Fogarty catheter insertion method was retrospectively validated. We compared outcomes between 60 patients who underwent the conventional method with a suction channel above the cuff and 50 patients who underwent the novel approach with an externally attached suction tube. RESULTS: The physicians performing bronchoscopy and inserting the Fogarty catheter in the group in which the suction tube was externally attached for Fogarty catheter insertion had little experience. However, the overall bronchoscopy time was shorter; the two groups showed no significant differences in complications. CONCLUSION: Regarding cryobiopsy procedures, using an externally attached suction tube for Fogarty catheter insertion was practical and comparable to the conventional method of using a suction channel above the cuff. This method made the procedure more simple and safe.


Asunto(s)
Broncoscopía , Intubación Intratraqueal , Humanos , Estudios Retrospectivos , Intubación Intratraqueal/instrumentación , Intubación Intratraqueal/métodos , Succión/instrumentación , Succión/métodos , Broncoscopía/métodos , Masculino , Femenino , Anciano , Biopsia/métodos , Biopsia/instrumentación , Persona de Mediana Edad , Catéteres , Criocirugía/métodos , Criocirugía/instrumentación
13.
Medicine (Baltimore) ; 103(29): e38493, 2024 Jul 19.
Artículo en Inglés | MEDLINE | ID: mdl-39029057

RESUMEN

Transbronchial lung cryobiopsy (TBCB) is a reliable method for obtaining histopathological findings in interstitial lung diseases. TBCB is traditionally performed during rigid bronchoscopy, positioning an endobronchial balloon blocker to facilitate bleeding management. Therefore, it can be challenging to implement in Centers without access to anesthesiologic support or dedicated beds for endoscopic procedures. We present a series of 11 patients who underwent 12 TBCBs using a flexible bronchoscope and a 5 Fr endobronchial blocker passing through an uncuffed endotracheal tube, under moderate sedation and spontaneous breathing. All procedures were carried out in an endoscopy suite, using fluoroscopy guidance but without requiring anesthesiologic assistance. TBCB was feasible in all cases, and it demonstrated similar or improved diagnostic yield (90.1%) and safety compared to rigid bronchoscopy. In 1 case, it was successfully repeated due to an inconclusive histological definition at the first attempt. The size of the samples was consistent with the literature, as it was the incidence of pneumothorax (16.6%). Four cases of moderate bleeding and 4 cases of severe bleeding were managed without further complications. To our knowledge, this is the first description of a technique allowing to perform TBCB through an artificial airway without need for either rigid bronchoscopy or general anesthesia. We believe this technique could make TBCB faster, cost-effective, and feasible even in resource-limited settings without compromising on safety. However, further studies are needed to validate these findings.


Asunto(s)
Broncoscopía , Sedación Consciente , Humanos , Broncoscopía/métodos , Broncoscopía/efectos adversos , Masculino , Sedación Consciente/métodos , Femenino , Persona de Mediana Edad , Anciano , Criocirugía/métodos , Criocirugía/instrumentación , Enfermedades Pulmonares Intersticiales/diagnóstico , Enfermedades Pulmonares Intersticiales/patología , Biopsia/métodos , Biopsia/efectos adversos , Biopsia/instrumentación , Pulmón/patología
14.
Braz J Cardiovasc Surg ; 39(2): e20230354, 2024 May 15.
Artículo en Inglés | MEDLINE | ID: mdl-38748605

RESUMEN

Postoperative pain after cardiac surgery plays an important role in the patient's recovery process. In particular, pain at the chest tube site can negatively affect the comfort and recovery of these patients. Effective pain control minimizes the risk of many complications. Oral and intravenous analgesics, epidural anesthesia, paravertebral block, and intercostal nerve blockade are used in chest tube pain control. We routinely use the surgical cryoablation method in the presence of atrial fibrillation in the preoperative period of cardiac surgery in our clinic. Here we aimed to describe our method of using the cryoablation catheter for intercostal nerve blockade.


Asunto(s)
Fibrilación Atrial , Tubos Torácicos , Criocirugía , Dolor Postoperatorio , Humanos , Fibrilación Atrial/cirugía , Dolor Postoperatorio/prevención & control , Dolor Postoperatorio/etiología , Criocirugía/métodos , Criocirugía/instrumentación , Bloqueo Nervioso/métodos , Procedimientos Quirúrgicos Cardíacos/métodos , Nervios Intercostales , Resultado del Tratamiento , Catéteres
15.
Artículo en Inglés | MEDLINE | ID: mdl-39119870

RESUMEN

BACKGROUND: Transbronchial cryobiopsy is a promising technique for biopsy of peripheral pulmonary lesions (PPL). However, cryobiopsy specimen retrieval can pose problems due to the risk of bleeding during the blind period when the bronchoscope and cryoprobe are removed en bloc. Artificial airways and prophylactic balloon placement are risk-reducing measures, but the latter is challenging in upper lobe PPL. Specimen retrieval through standard guide sheath (GS) system without the need for bronchoscope removal may now be feasible with the ultrathin cryoprobe. METHODS: Retrospective review of radial endobronchial ultrasound (rEBUS)-guided transbronchial cryobiopsy for PPL cases in which cryobiopsy specimen was retrieved through the GS over a 6-month period. RESULTS: Twenty patients were included with an overall median age of 66.50 (IQR: 53.0 to 76.7). The median procedural time was 30 (IQR: 25.0 to 33.7) minutes. Median target size was 3.20 (IQR: 2.17 to 4.84) cm with 85% of lesions demonstrated "within" rEBUS orientation. Overall technical feasibility was 85% with median cryoactivation of 4.0 (IQR: 3.0 to 4.0) seconds. No specimen was retrieved in 3 patients. The diagnostic yield for forceps and cryobiopsy was 70% and 60%, respectively, and the combined diagnostic yield was 85% (P<0.01 vs. forceps biopsy). Median aggregate size for forceps and cryobiopsy was 8.0 (IQR: 5.3 to 10.0) and 4.5 (IQR: 2.3 to 7.0) mm respectively (P<0.01). No pneumothorax was reported and mild self-limiting bleeding was encountered in 30% of cases. CONCLUSION: Retrieval of cryoprobe through standard GS appears to be a safe and feasible method that can simplify the transbronchial cryobiopsy procedure and complement forceps biopsy in specific cases.


Asunto(s)
Broncoscopía , Criocirugía , Estudios de Factibilidad , Humanos , Anciano , Estudios Retrospectivos , Masculino , Persona de Mediana Edad , Femenino , Broncoscopía/métodos , Broncoscopía/instrumentación , Criocirugía/métodos , Criocirugía/instrumentación , Biopsia/métodos , Biopsia/instrumentación , Pulmón/patología , Neoplasias Pulmonares/patología , Neoplasias Pulmonares/cirugía , Manejo de Especímenes/métodos
19.
Arch. esp. urol. (Ed. impr.) ; 66(6): 546-556, jul.-ago. 2013. tab
Artículo en Español | IBECS (España) | ID: ibc-114157

RESUMEN

OBJETIVO: La criocirugía del cáncer de próstata ha evolucionado hasta convertirse en un tratamiento alternativo razonable para el cáncer de próstata localizado. La llegada de la tercera generación de máquinas y crio sondas más pequeñas junto con mejores técnicas de imagen permiten un tratamiento preciso de la próstata en el escenario principal, de rescate y focal. MÉTODOS: Se llevó a cabo una revisión exhaustiva de la literatura desde 1980 a enero de 2013 buscando en la base de datos Medline. Se extrajo información con respecto a los resultados oncológicos y funcionales. RESULTADOS: Los resultados de la criocirugía han mejorado con el tiempo, con tasas de supervivencia libre de enfermedad bioquímica ahora comparables con otras modalidades de tratamiento. Inicialmente descrita en el contexto de rescate tras la radioterapia, la tecnología se amplió posteriormente como tratamiento primario y, más recientemente, para la terapia focal. Con la introducción del sistema de criocirugía de tercera generación y mejores modalidades de imágen, la morbilidad relacionada con el tratamiento ha disminuido. CONCLUSIONES: Los resultados oncológicos y funcionales han mejorado y está aumentando el uso de la técnica. Los criterios de inclusión y protocolos de seguimiento todavía necesitan de estudios prospectivos para establecer la eficacia del procedimiento en comparación con las opciones establecidas de manejo local (AU)


OBJECTIVES: Cryosurgery for prostate cancer has evolved to become a reasonable treatment alternative for localized prostate cancer. The advent of third-generation machines and smaller cryoprobes together with better imaging modalities allows for precise treatment of the prostate in the primary, salvage and focal setting. METHODS: A comprehensive review of the literature was performed from 1980 to January 2013 searching the Medline database. Information was extracted regarding oncologic and functional outcomes. RESULTS: The outcomes of cryosurgery improved over time with intermediate biochemical disease free survival rates now comparable to other treatment modalities. Initially reported in the salvage setting after radiation therapy, the technology was subsequently expanded as primary treatment and more recently for focal therapy. With introduction of the third-generation cryosurgery system and better imaging modalities, the treatment related morbidities have decreased. CONCLUSIONS: Oncologic and functional outcomes have improved and the procedure is increasing in use. Variable inclusion criteria and follow-up protocols still call for prospective studies to establish the efficacy of the procedure as compared to established local management options (AU)


Asunto(s)
Humanos , Masculino , Neoplasias de la Próstata/terapia , Neoplasias de la Próstata , Criocirugía/instrumentación , Criocirugía/métodos , Criocirugía , Análisis de Supervivencia , Tasa de Supervivencia/tendencias , Neoplasias de la Próstata/radioterapia , Indicadores de Morbimortalidad
20.
Arch. esp. urol. (Ed. impr.) ; 66(1): 41-53, ene.-feb. 2013. ilus, tab
Artículo en Español | IBECS (España) | ID: ibc-109410

RESUMEN

OBJETIVO: Presentar una revisión actualizada de la literatura disponible sobre crioablación laparoscópica de pequeñas masas renales (SRMs), incluyendo descripción de la técnica, indicaciones y resultados. MÉTODOS: Se realizó una revisión de la literatura hasta marzo de 2012, utilizando las bases de datos MEDLINE y EMBASE vía Ovid, para identificar estudios sobre crioablación laparoscópica de SRMs publicados durante los últimos 10 años. Sólo se incluyeron manuscritos en inglés y estudios basados en humanos, que reportaron series con más de 20 participantes, características de los pacientes, eficacia y seguridad del procedimiento. RESULTADOS: No se identificaron ensayos clínicos aleatorizados (RCTs). En total, se seleccionaron 27 trabajos originales sobre crioablación laparoscópica (LCA) de SRMs. El número de pacientes por estudio osciló entre 20 y 144. La edad media de los mismos a lo largo de las series osciló entre 62 y 73 años. El tamaño medio de los tumores renales osciló entre 2,7 y 4 cm, siendo en la mayoría de los casos ≤3 cm. El número de crioagujas utilizadas para crioablación osciló entre 1 y 6, mientras que sólo en 10 series se describió la utilización de crioagujas de tercera generación de 17 gauge (1,47 mm).En total, más del 55% de las lesiones tratadas resultaron carcinoma de células renales (RCC) confirmado por el análisis anatomopatológico. El seguimiento medio de los pacientes osciló entre 9 y 93 meses. Sólo 7 series presentaron un seguimiento a largo plazo superior a 36 meses. La mayoría de los estudios resultaron limitados por un seguimiento relativamente corto. Al menos cuatro grupos de investigación reportaron resultados a intermedio y a largo plazo. Las tasas de persistencia tumoral oscilaron entre 0% y 17%, mientras que las tasas de recidiva oscilaron entre 0% y 14%. La tasa global de complicaciones osciló entre 0% y 40%(AU)


CONCLUSIONES: Los datos de estudios observacionales y retrospectivos así como los de algunas series prospectivas, demostraron aceptables resultados oncológicos a 3 y 5 años y una baja tasa de recidiva. La LCA demostró ser un procedimiento seguro con una baja tasa global de complicaciones. Está indicada principalmente en el tratamiento de SRMs en pacientes añosos con alta comorbilidad y elevado riesgo quirúrgico, albergando tumores en la valva anterior del riñón o en contacto con el uréter u órganos vecinos(AU)


OBJECTIVES: To provide an up-to-date review of the available literature on laparoscopic cryotherapy for small renal masses (SRMs) including technique description, indications and outcomes. METHODS: A systematic literature search was conducted in March 2012, using MEDLINE and EMBASE via Ovid databases, to identify studies on laparoscopic cryotherapy for SRMs published during the last 10 years. Only English-language and human-based full manuscripts reporting case series studies with >20 participants, patient characteristics, efficacy and safety data were included. RESULTS: No randomised controlled trials (RCTs) were identified. In total, 27 full reports addressing laparoscopic cryoablation (LCA) for SRMs were selected. The number of patients per study ranged from 20 to 144. Mean age of treated patients across the series ranged from 62 to 73 years. Mean size of renal tumors ranged from 2.7 to 4 cm, being in most cases <3 cm. The number of cryoprobes used for cryoablation ranged from 1 to 6, and only 10 series described the use of 17-gauge (1.47 mm) third-generation needles. Overall, more than 55% of all ablated lesions were pathologically confirmed RCC.Mean follow-up ranged from 9 to 93 months. Only 7 series presented a long-term follow-up of more than 36 months. Most studies were limited by a relatively short follow-up. At least four urologic groups reported intermediate- and long-term outcomes. Persistence rates ranged from 0% to 17% and recurrence rates ranged from 0% to 14%. Overall complication rates ranged from 0% to 40%(AU)


CONCLUSIONS: Retrospective observational data and a few prospective series on LCA of SRMs show acceptable oncological 3- to 5-year outcomes with a low recurrence rate. It has proven to be a safe procedure with an overall low complication rate. It is mainly indicated for SRMs in elderly patients affected by co-morbidity and high surgical risk bearing tumours in the anterior valve of the kidney or in contact with the ureter or neighbouring organs(AU)


Asunto(s)
Humanos , Masculino , Femenino , Persona de Mediana Edad , Criocirugía/métodos , Criocirugía/tendencias , Criocirugía , Laparoscopía/métodos , Laparoscopía/tendencias , Laparoscopía , Neoplasias Renales/diagnóstico , Neoplasias Renales/cirugía , Criocirugía/instrumentación , Criocirugía/normas , Resultado del Tratamiento , Evaluación de Eficacia-Efectividad de Intervenciones , Estudios Retrospectivos , Comorbilidad , Neoplasias Renales/fisiopatología , Neoplasias Renales
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