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1.
N Engl J Med ; 388(2): 105-116, 2023 01 12.
Article in English | MEDLINE | ID: mdl-36342178

ABSTRACT

BACKGROUND: Atrial fibrillation is a chronic, progressive disorder, and persistent forms of atrial fibrillation are associated with increased risks of thromboembolism and heart failure. Catheter ablation as initial therapy may modify the pathogenic mechanism of atrial fibrillation and alter progression to persistent atrial fibrillation. METHODS: We report the 3-year follow-up of patients with paroxysmal, untreated atrial fibrillation who were enrolled in a trial in which they had been randomly assigned to undergo initial rhythm-control therapy with cryoballoon ablation or to receive antiarrhythmic drug therapy. All the patients had implantable loop recorders placed at the time of trial entry, and evaluation was conducted by means of downloaded daily recordings and in-person visits every 6 months. Data regarding the first episode of persistent atrial fibrillation (lasting ≥7 days or lasting 48 hours to 7 days but requiring cardioversion for termination), recurrent atrial tachyarrhythmia (defined as atrial fibrillation, flutter, or tachycardia lasting ≥30 seconds), the burden of atrial fibrillation (percentage of time in atrial fibrillation), quality-of-life metrics, health care utilization, and safety were collected. RESULTS: A total of 303 patients were enrolled, with 154 patients assigned to undergo initial rhythm-control therapy with cryoballoon ablation and 149 assigned to receive antiarrhythmic drug therapy. Over 36 months of follow-up, 3 patients (1.9%) in the ablation group had an episode of persistent atrial fibrillation, as compared with 11 patients (7.4%) in the antiarrhythmic drug group (hazard ratio, 0.25; 95% confidence interval [CI], 0.09 to 0.70). Recurrent atrial tachyarrhythmia occurred in 87 patients in the ablation group (56.5%) and in 115 in the antiarrhythmic drug group (77.2%) (hazard ratio, 0.51; 95% CI, 0.38 to 0.67). The median percentage of time in atrial fibrillation was 0.00% (interquartile range, 0.00 to 0.12) in the ablation group and 0.24% (interquartile range, 0.01 to 0.94) in the antiarrhythmic drug group. At 3 years, 8 patients (5.2%) in the ablation group and 25 (16.8%) in the antiarrhythmic drug group had been hospitalized (relative risk, 0.31; 95% CI, 0.14 to 0.66). Serious adverse events occurred in 7 patients (4.5%) in the ablation group and in 15 (10.1%) in the antiarrhythmic drug group. CONCLUSIONS: Initial treatment of paroxysmal atrial fibrillation with catheter cryoballoon ablation was associated with a lower incidence of persistent atrial fibrillation or recurrent atrial tachyarrhythmia over 3 years of follow-up than initial use of antiarrhythmic drugs. (Funded by the Cardiac Arrhythmia Network of Canada and others; EARLY-AF ClinicalTrials.gov number, NCT02825979.).


Subject(s)
Anti-Arrhythmia Agents , Atrial Fibrillation , Catheter Ablation , Cryosurgery , Humans , Anti-Arrhythmia Agents/adverse effects , Anti-Arrhythmia Agents/therapeutic use , Atrial Fibrillation/drug therapy , Atrial Fibrillation/etiology , Catheter Ablation/adverse effects , Catheter Ablation/methods , Cryosurgery/adverse effects , Cryosurgery/methods , Recurrence , Tachycardia/etiology , Treatment Outcome , Disease Progression , Follow-Up Studies
2.
Gastroenterology ; 167(4): 764-777, 2024 Sep.
Article in English | MEDLINE | ID: mdl-38795735

ABSTRACT

BACKGROUND & AIMS: Endoscopic mucosal resection (EMR) is standard therapy for nonpedunculated colorectal polyps ≥20 mm. It has been suggested recently that polyp resection without current (cold resection) may be superior to the standard technique using cutting/coagulation current (hot resection) by reducing adverse events (AEs), but evidence from a randomized trial is missing. METHODS: In this randomized controlled multicentric trial involving 19 centers, nonpedunculated colorectal polyps ≥20 mm were randomly assigned to cold or hot EMR. The primary outcome was major AE (eg, perforation or postendoscopic bleeding). Among secondary outcomes, major AE subcategories, postpolypectomy syndrome, and residual adenoma were most relevant. RESULTS: Between 2021 and 2023, there were 396 polyps in 363 patients (48.2% were female) enrolled for the intention-to-treat analysis. Major AEs occurred in 1.0% of the cold group and in 7.9% of the hot group (P = .001; odds ratio [OR], 0.12; 95% CI, 0.03-0.54). Rates for perforation and postendoscopic bleeding were significantly lower in the cold group, with 0% vs 3.9% (P = .007) and 1.0% vs 4.4% (P = .040). Postpolypectomy syndrome occurred with similar frequency (3.1% vs 4.4%; P = .490). After cold resection, residual adenoma was found more frequently, with 23.7% vs 13.8% (P = .020; OR, 1.94; 95% CI, 1.12-3.38). In multivariable analysis, lesion diameter of ≥4 cm was an independent predictor both for major AEs (OR, 3.37) and residual adenoma (OR, 2.47) and high-grade dysplasia/cancer for residual adenoma (OR, 2.92). CONCLUSIONS: Cold resection of large, nonpedunculated colorectal polyps appears to be considerably safer than hot EMR; however, at the cost of a higher residual adenoma rate. Further studies have to confirm to what extent polyp size and histology can determine an individualized approach. German Clinical Trials Registry (Deutsches Register Klinischer Studien), Number DRKS00025170.


Subject(s)
Colonic Polyps , Colonoscopy , Endoscopic Mucosal Resection , Postoperative Hemorrhage , Humans , Female , Male , Colonic Polyps/surgery , Colonic Polyps/pathology , Endoscopic Mucosal Resection/adverse effects , Endoscopic Mucosal Resection/methods , Middle Aged , Aged , Colonoscopy/methods , Colonoscopy/adverse effects , Germany , Treatment Outcome , Postoperative Hemorrhage/etiology , Postoperative Hemorrhage/epidemiology , Adenoma/surgery , Adenoma/pathology , Intestinal Perforation/etiology , Intestinal Perforation/epidemiology , Intestinal Perforation/surgery , Neoplasm, Residual , Postoperative Complications/etiology , Postoperative Complications/epidemiology , Tumor Burden , Colorectal Neoplasms/surgery , Colorectal Neoplasms/pathology , Cryosurgery/adverse effects , Cryosurgery/methods
3.
Ann Intern Med ; 177(8): JC93, 2024 Aug.
Article in English | MEDLINE | ID: mdl-39102725

ABSTRACT

SOURCE CITATION: Kalverda KA, Ninaber MK, Wijmans L, et al. Transbronchial cryobiopsy followed by as-needed surgical lung biopsy versus immediate surgical lung biopsy for diagnosing interstitial lung disease (the COLD study): a randomised controlled trial. Lancet Respir Med. 2024;12:513-522. 38640934.


Subject(s)
Chest Tubes , Drainage , Lung Diseases, Interstitial , Humans , Biopsy/methods , Biopsy/adverse effects , Lung Diseases, Interstitial/pathology , Lung Diseases, Interstitial/diagnosis , Lung/pathology , Lung/diagnostic imaging , Male , Female , Middle Aged , Aged , Cryosurgery/methods
4.
Ann Surg ; 279(4): 699-704, 2024 Apr 01.
Article in English | MEDLINE | ID: mdl-37791468

ABSTRACT

OBJECTIVE: To examine differences in opioid use, length of stay, and adverse events after minimally invasive correction of pectus excavatum (MIRPE) with and without intercostal nerve cryoablation. BACKGROUND: Small studies show that intraoperative intercostal nerve cryoablation provides effective analgesia with no large-scale evaluations of this technique. METHODS: The pediatric health information system database was used to perform a retrospective cohort study comparing patients undergoing MIRPE at children's hospitals before and after the initiation of cryoablation. The association of cryoablation use with inpatient opioid use was determined using quantile regression with robust standard errors. Difference in risk-adjusted length of stay between the cohorts was estimated using negative binomial regression. Odds of adverse events between the two cohorts were compared using logistic regression with a generalized estimating equation. RESULTS: A total of 5442 patients underwent MIRPE at 44 children's hospitals between 2016 and 2022 with 1592 patients treated after cryoablation was introduced at their hospital. Cryoablation use was associated with a median decrease of 80.8 (95% CI: 68.6-93.0) total oral morphine equivalents as well as a decrease in estimated median length of stay from 3.5 [3.2-3.9] days to 2.5 [2.2-2.9] days ( P value: 0.016). Cryoablation use was not significantly associated with an increase in any studied adverse events. CONCLUSIONS: Introduction of cryoablation for perioperative analgesia was associated with decreased inpatient opioid use and length of stay in a large sample with no change in adverse events. This novel modality for perioperative analgesia offers a promising alternative to traditional pain management in thoracic surgery.


Subject(s)
Cryosurgery , Funnel Chest , Opioid-Related Disorders , Humans , Child , Cryosurgery/adverse effects , Cryosurgery/methods , Analgesics, Opioid/therapeutic use , Length of Stay , Retrospective Studies , Pain, Postoperative/therapy , Funnel Chest/surgery , Intercostal Nerves/surgery , Opioid-Related Disorders/etiology , Minimally Invasive Surgical Procedures/methods
5.
Thorax ; 79(7): 633-643, 2024 Jun 14.
Article in English | MEDLINE | ID: mdl-38242710

ABSTRACT

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.


Subject(s)
Bronchoscopy , Cryosurgery , Lung Neoplasms , Cryosurgery/methods , Cryosurgery/instrumentation , Animals , Lung Neoplasms/surgery , Lung Neoplasms/pathology , Swine , Humans , Bronchoscopy/methods , Male , Female , Aged , Middle Aged , Treatment Outcome , Cone-Beam Computed Tomography
6.
Breast Cancer Res Treat ; 206(3): 561-573, 2024 Aug.
Article in English | MEDLINE | ID: mdl-38814508

ABSTRACT

BACKGROUND: Breast cancer remains the most commonly diagnosed cancer in women. Breast-conserving surgery (BCS) is the standard approach for small low-risk tumors. If the efficacy of cryoablation is demonstrated, it could provide a minimally invasive alternative to surgery. PURPOSE: To determine the success of ultrasound-guided cryoablation in achieving the absence of Residual Invasive Cancer (RIC) for patients with ER + /HER2- tumors ≤ 2cm and sonographically negative axillary nodes. MATERIALS AND METHODS: This prospective study was carried out from April 2021 to June 2023, and involved 60 preoperative cryoablation procedures on ultrasound-visible, node-negative (cN0) infiltrating ductal carcinomas (IDC). Standard diagnostic imaging included mammography and tomosynthesis, supplemented by ultrasound-guided biopsy. MRI was performed in patients with associated intraductal carcinoma (DCIS) and an invasive component on core needle biopsy (18 out of 22 cases). All tumors were tagged with ferromagnetic seeds. A triple-phase protocol (freezing-thawing-freezing) with Argon was used, with an average procedure duration of 40 min. A logistic regression model was applied to determine significant correlation between RIC and the study variables. RESULTS: Fifty-nine women (mean age 63 ± 8 years) with sixty low-risk unifocal IDC underwent cryoablation prior to surgery. Pathological examination of lumpectomy specimens post-cryoablation revealed RIC in only one of 38 patients with pure IDC and in 4 of 22 mixed IDC/DCIS cases. All treated tumors had clear surgical margins, with no significant procedural complications. CONCLUSIONS: Cryoablation was effective in eradicating 97% of pure infiltrating ER + /HER2-tumors ≤ 2cm, demonstrating its potential as a surgical alternative in selected patients.


Subject(s)
Breast Neoplasms , Cryosurgery , Receptor, ErbB-2 , Humans , Female , Cryosurgery/methods , Breast Neoplasms/surgery , Breast Neoplasms/pathology , Breast Neoplasms/diagnostic imaging , Middle Aged , Aged , Receptor, ErbB-2/metabolism , Prospective Studies , Prognosis , Neoplasm, Residual , Adult , Receptors, Estrogen/metabolism , Carcinoma, Ductal, Breast/surgery , Carcinoma, Ductal, Breast/pathology , Carcinoma, Ductal, Breast/diagnostic imaging , Mastectomy, Segmental/methods , Aged, 80 and over , Preoperative Care/methods
7.
J Cardiovasc Electrophysiol ; 35(1): 162-170, 2024 Jan.
Article in English | MEDLINE | ID: mdl-38009545

ABSTRACT

INTRODUCTION: Pulsed field ablation (PFA) represents a novel, nonthermal energy modality that can be applied for single-shot pulmonary vein isolation (PVI) in atrial fibrillation (AF). Comparative data with regard to deep sedation to established single-shot modalities such as cryoballoon (CB) ablation are scarce. The aim of this study was to compare a deep sedation protocol in patients receiving PVI with either PFA or CB. METHODS: Prospective, consecutive AF patients undergoing PVI with a pentaspline PFA catheter were compared to a retrospective CB-PVI cohort of the same timeframe. Study endpoints were the requirements of analgesics, cardiorespiratory stability, and sedation-associated complications. RESULTS: A total of 100 PVI patients were included (PFA n = 50, CB n = 50, mean age 66 ± 10.6, 61% male patients, 65% paroxysmal AF). Requirement of propofol, midazolam, and sufentanyl was significantly higher in the PFA group compared to CB [propofol 0.14 ± 0.04 mg/kg/min in PFA vs. 0.11 ± 0.04 mg/kg/min in CB (p = .001); midazolam 0.00086 ± 0.0004 mg/kg/min in PFA vs. 0.0006295 ± 0.0003 mg/kg/min in CB (p = .002) and sufentanyl 0.0013 ± 0.0007 µg/kg/min in PFA vs. 0.0008 ± 0.0004 µg/kg/min in CB (p < .0001)]. Sedation-associated complications did not differ between both groups (PFA n = 1/50 mild aspiration pneumonia, CB n = 0/50, p > .99). Nonsedation-associated complications (PFA: n = 2/50, 4%, CB: n = 1/50, 2%, p > .99) and procedure times (PFA 75 ± 31, CB 84 ± 32 min, p = .18) did not differ between groups. CONCLUSIONS: PFA is associated with higher sedation and especially analgesia requirements. However, the safety of deep sedation does not differ to CB ablation.


Subject(s)
Analgesia , Atrial Fibrillation , Cryosurgery , Propofol , Humans , Male , Middle Aged , Aged , Female , Atrial Fibrillation/diagnosis , Atrial Fibrillation/surgery , Retrospective Studies , Prospective Studies , Midazolam/adverse effects , Cryosurgery/adverse effects , Cryosurgery/methods
8.
J Cardiovasc Electrophysiol ; 35(1): 69-77, 2024 Jan.
Article in English | MEDLINE | ID: mdl-37927151

ABSTRACT

INTRODUCTION: Influence of early atrial fibrillation (AF) ablation, particularly cryoballoon ablation (CBA), on clinical outcome during long-term follow-up has not been clarified. The objective was to determine whether an early CBA (diagnosis-to-ablation of ≤6 months) strategy could affect freedom from AF recurrence after index CBA. METHODS: The study included 2605 patients from Korean CBA registry data with follow-up >12 months after de novo CBA. The primary outcome was recurrence of atrial tachyarrhythmias (ATs) of ≥30-s after a 3-month blanking period. RESULTS: Compared to patients in early CBA group, patients in late CBA group had higher prevalence of diabetes, congestive heart failure, and chronic kidney disease, and higher mean CHA2 DS2 -VAS score. During mean follow-up of >21 months, ATs recurrence was detected in 839 (32.2%) patients. The early CBA group showed a significantly lower 2-year recurrence rate of ATs than the late CBA group (26.1% vs. 31.7%, p = 0.043). In subgroup analysis, the early CBA group showed significantly higher 1-year and 2-year freedom from ATs recurrence than the late CBA group only in paroxysmal atrial fibrillation (PAF) patients in overall and propensity score matched cohorts. Multivariate analysis showed that early CBA was an independent factor for preventing ATs recurrence in PAF (hazard ratio: 0.637; 95% confidence intervals: 0.412-0.984). CONCLUSION: Early CBA strategy, resulting in significantly lower ATs recurrence during 2-year follow-up after index CBA, might be considered as an initial rhythm control therapy in patients with paroxysmal AF.


Subject(s)
Atrial Fibrillation , Catheter Ablation , Cryosurgery , Pulmonary Veins , Humans , Atrial Fibrillation/diagnosis , Atrial Fibrillation/epidemiology , Atrial Fibrillation/surgery , Cryosurgery/adverse effects , Cryosurgery/methods , Heart Atria , Republic of Korea/epidemiology , Treatment Outcome , Catheter Ablation/adverse effects , Recurrence , Pulmonary Veins/surgery
9.
J Cardiovasc Electrophysiol ; 35(1): 198-205, 2024 Jan.
Article in English | MEDLINE | ID: mdl-38037864

ABSTRACT

INTRODUCTION: The major limitation of the current cryoballoon (CB) system is a fixed 28 mm balloon-size. We sought to analyze real-world early experience with novel-sized adjustable CB. METHODS: This multicenter observational study included 140 consecutive atrial fibrillation patients (71 years, 94 men, 86 paroxysmal) who underwent pulmonary vein (PV) isolation using expandable diameter CB capable of ablation at 28 or 31 mm. RESULTS: Out of 544 targeted PVs, 526 (96.7%) were successfully isolated by a size-adjustable CB with a 770 [690-870] second median application dose, while the remaining 18 required touch-up ablation. Among them, 326 (62.0%) PVs were isolated by a 31 mm balloon, and the rate was significantly higher for upper than lower PVs (73.0% vs. 45.7%, p < .0001) and highest for right superior (78.5%) and lowest for right inferior (39.9%) PVs. The biophysical parameters and time to isolation were comparable between the 28 and 31 mm balloons, however, the real-time PV potential monitoring capability was significantly higher for 31 mm than 28 mm balloons for the left superior PV. The esophageal temperature reached 15°C during left inferior PV ablation significantly more often with 31 mm than 28 mm balloons (43.1% vs. 18.2%, p = .008). Right phrenic nerve injury (PNI) occurred in 9 (6.4%) patients during applications (6 right superior, 2 right inferior PVs), and most occurred with a 31 mm balloon. CONCLUSIONS: Our real-world early data demonstrated high acute efficacy and safety of the novel-sized adjustable CB. The biophysical parameters were similar between the 28 and 31 mm balloons. No marked decrease in the incidence of PNI was observed even with 31 mm balloons.


Subject(s)
Atrial Fibrillation , Catheter Ablation , Cryosurgery , Pulmonary Veins , Humans , Male , Atrial Fibrillation/diagnosis , Atrial Fibrillation/surgery , Atrial Fibrillation/epidemiology , Catheter Ablation/adverse effects , Catheter Ablation/methods , Cryosurgery/adverse effects , Cryosurgery/methods , Pulmonary Veins/surgery , Treatment Outcome , Female
10.
J Cardiovasc Electrophysiol ; 35(4): 832-842, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38448797

ABSTRACT

INTRODUCTION: Cryoablation therapy for pulmonary vein isolation (PVI) to treat paroxysmal atrial fibrillation (PAF) is well established. A novel 28 mm cryoballoon system designed to operate under low pressure to safely reach a lower nadir temperature and maintain constant balloon size during cooling has not been prospectively studied in a large patient population for safety and efficacy. The FROZEN AF (NCT04133168) trial was an international multicenter, open-label, prospective, single-arm study on the safety and performance of a novel cryoballoon system for treatment of PAF. METHODS AND RESULTS: The study enrolled patients at 44 sites in 10 countries across North America, Europe, and Asia. Subjects were indicated for PVI treatment of PAF and had failed or were intolerant of one or more antiarrhythmic drugs. Procedural outcomes were defined based on the 2017 HRS consensus statement. Follow-up was performed at 7 days, 3, 6, and 12 months. Data are reported as mean ± SD or median (IQR). PVI was performed with a 28 mm cryoballoon in 325 drug refractory PAF patients. Complete PVI was achieved in 95.7% of patients. In cryoablation lesions longer than 60 s, 60.1% of PV isolations required only a single cryoballoon application. Procedure related complications included: phrenic nerve palsy [temporary 4 (1.2%), persistent 0 (0.0%)], cardiac tamponade/perforation 2 (0.6%), and air embolism 1 (0.3%). Freedom from documented atrial arrhythmia recurrence at 12 months was 79.9% (AF 82.7%, AFL 96.5%, AT 98.1%), antiarrhythmic drugs (AAD) were continued or re-initiated in 26.8% of patients after the 3-month blanking period. Additionally, an extension arm enrolled 50 pts for treatment with 28/31 mm variable size cryoballoon. A single temporary PNP occurred in this group, which resolved before discharge. Freedom from documented recurrence at 12 months in these pts was 82.0%. CONCLUSIONS: This novel cryoballoon may facilitate PVI to treat PAF, providing more options to address the variety of anatomies present in patients with PAF. This cryoballoon system proved to be safe and effective for treatment of patients with drug refractory or drug intolerant PAF.


Subject(s)
Atrial Fibrillation , Catheter Ablation , Cryosurgery , Heart Injuries , Pulmonary Veins , Humans , Anti-Arrhythmia Agents/therapeutic use , Atrial Fibrillation/diagnosis , Atrial Fibrillation/surgery , Atrial Fibrillation/epidemiology , Catheter Ablation/adverse effects , Catheter Ablation/methods , Cryosurgery/adverse effects , Cryosurgery/methods , Heart Injuries/etiology , Prospective Studies , Pulmonary Veins/surgery , Recurrence , Treatment Outcome
11.
BMC Cancer ; 24(1): 825, 2024 Jul 10.
Article in English | MEDLINE | ID: mdl-38987735

ABSTRACT

Immune response is known to play an important role in local tumor control especially in renal cell carcinoma (RCC), which is considered highly immunogenic. For localized tumors, operative resection or local ablative procedures such as cryoablation are common therapeutical options. For thermal ablative procedures such as cryoablation, additional immunological anti-tumor effects have been described.The purpose of this prospective study was to determine changes in peripheral blood circulating lymphocytes and various of their subsets in RCC patients treated with cryoablation or surgery in a longitudinal approach using extensive flow cytometry. Additionally, lymphocytes of RCC patients were compared to a healthy control group.We included 25 patients with RCC. Eight underwent cryoablation and 17 underwent surgery. Univariate and multivariable analysis revealed significantly lower values of B cells, CD4 and CD8 T cells, and various of their subsets in the treatment groups versus the healthy control group. Comparing the two different therapeutical approaches, a significant decline of various lymphocyte subsets with a consecutive normalization after three months was seen for the surgery group, whereas cryoablation led to increased values of CD69 + CD4 + and CD69 + CD8 + cell counts as well as memory CD8 + cells after three months.Treatment-naïve RCC patients showed lower peripheral blood lymphocyte counts compared to healthy controls. The post-treatment course revealed different developments of lymphocytes in the surgery versus cryoablation group, and only cryoablation seems to induce a sustained immunological response after three months.


Subject(s)
Carcinoma, Renal Cell , Cryosurgery , Kidney Neoplasms , Lymphocyte Subsets , Humans , Carcinoma, Renal Cell/surgery , Carcinoma, Renal Cell/immunology , Carcinoma, Renal Cell/blood , Carcinoma, Renal Cell/pathology , Cryosurgery/methods , Male , Female , Middle Aged , Kidney Neoplasms/surgery , Kidney Neoplasms/immunology , Kidney Neoplasms/blood , Kidney Neoplasms/pathology , Aged , Lymphocyte Subsets/immunology , Prospective Studies , Lymphocyte Count , Neoplasm Staging , Adult , CD8-Positive T-Lymphocytes/immunology , Flow Cytometry , Treatment Outcome
12.
Curr Opin Gastroenterol ; 40(5): 330-337, 2024 Sep 01.
Article in English | MEDLINE | ID: mdl-38662539

ABSTRACT

PURPOSE OF REVIEW: Endoscopic cryotherapy has emerged as a minimally invasive procedure for targeted tissue ablation within the gastrointestinal tract. This review aims to provide a comprehensive overview of current clinical applications of EC with a review of the pertinent literature. RECENT FINDINGS: Endoscopic cryotherapy has demonstrated safety and efficacy for various gastrointestinal conditions. Recent studies have highlighted the efficacy of endoscopic cryotherapy, including both liquid nitrogen-based spray cryotherapy and the novel cryoballoon focal ablation system, in achieving complete eradication of dysplasia and neoplasia in Barrett's esophagus. Endoscopic cryotherapy has also shown promise as a second-line treatment option for patients with dysplastic Barrett's esophagus refractory to radiofrequency ablation and as an alternative to surgical resection for duodenal adenomas, when endoscopic resection is not feasible. Innovative applications for the treatment of gastrointestinal bleeding and management of benign refractory esophageal strictures have also been reported. SUMMARY: Endoscopic cryotherapy represents a safe, effective, and well tolerated therapeutic option for various clinical scenarios in gastrointestinal endoscopy, including challenging disease states such as refractory Barrett's esophagus and advanced esophageal cancer. Advancements in cryotherapy technology and ongoing research continue to explore additional clinical indications and expand the role of endoscopic cryotherapy in patient care with an aim toward improved patient outcomes.


Subject(s)
Cryosurgery , Endoscopy, Gastrointestinal , Humans , Cryosurgery/methods , Endoscopy, Gastrointestinal/methods , Barrett Esophagus/surgery , Barrett Esophagus/therapy , Cryotherapy/methods , Esophageal Neoplasms/surgery , Esophageal Neoplasms/therapy , Treatment Outcome , Gastrointestinal Hemorrhage/therapy , Gastrointestinal Hemorrhage/etiology , Esophageal Stenosis/therapy , Esophageal Stenosis/surgery , Esophageal Stenosis/etiology
13.
Gastrointest Endosc ; 100(3): 429-437, 2024 Sep.
Article in English | MEDLINE | ID: mdl-38431103

ABSTRACT

BACKGROUND AND AIMS: Endoscopic resection is a minimally invasive treatment for superficial esophageal squamous cell carcinoma (SESCC). Post-endoscopic resection scars complicate en-bloc resection, even with advanced techniques, such as endoscopic submucosal dissection. The cryoballoon ablation system (CBAS) effectively manages Barrett's esophagus but has limited evidence in SESCC treatment, particularly on post-endoscopic resection scars. This study aimed to evaluate the efficacy and safety of the CBAS for treating SESCC on post-endoscopic resection scars. METHODS: This prospective study was conducted at 2 tertiary referral centers in Japan in patients endoscopically diagnosed with T1a SESCC on the post-endoscopic resection scar. Focal CBAS was used for cryoablation, with specific criteria for lesion selection and treatment method. The primary endpoint was the rate of local complete response (L-CR) of the primary lesion 48 weeks after the first cryoablation as evaluated by an independent central evaluation committee. RESULTS: From October 2020 to October 2021, 15 patients with 17 lesions underwent cryoablation, with 2 requiring repeat cryoablation. The L-CR rate for primary and all lesions evaluated by the central evaluation committee was 100%. The endoscopist's evaluation was consistent with these results. The median procedure time was 9 minutes. Eight patients experienced no pain, and the highest pain score reported on a numeric rating scale from 1 to 10 was 3. The technical success rate was 94.7% (18/19). Throughout the median follow-up period of 14.3 months, recurrences, deaths, or severe treatment-related adverse events were not reported. CONCLUSIONS: CBAS is a potentially safe and effective approach for SESCC on post-endoscopic resection scars and represents an encouraging alternative to traditional endoscopic treatments. (Clinical trial registration numbers: NCT03097666 and jRCT1080225331.).


Subject(s)
Cicatrix , Cryosurgery , Endoscopic Mucosal Resection , Esophageal Neoplasms , Esophageal Squamous Cell Carcinoma , Humans , Male , Cryosurgery/methods , Cryosurgery/adverse effects , Female , Esophageal Neoplasms/surgery , Aged , Prospective Studies , Middle Aged , Esophageal Squamous Cell Carcinoma/surgery , Cicatrix/etiology , Endoscopic Mucosal Resection/methods , Endoscopic Mucosal Resection/adverse effects , Esophagoscopy/methods , Aged, 80 and over , Treatment Outcome
14.
Gastrointest Endosc ; 100(2): 200-209, 2024 Aug.
Article in English | MEDLINE | ID: mdl-38272279

ABSTRACT

BACKGROUND AND AIMS: Liquid nitrogen spray cryotherapy (SCT) is an alternative to radiofrequency ablation (RFA) for eradication of dysplastic Barrett's esophagus (BE). We aimed to assess the safety, efficacy, and durability of SCT in a multicenter U.S. registry. METHODS: This is a multicenter prospective registry of adults with BE treated with truFreeze Spray Cryotherapy (Steris, Mentor, Ohio, USA) (4 community and 11 academic sites, 2013-2022). Complete eradication of intestinal metaplasia (CEIM) and dysplasia (CED) were assessed in BE with dysplasia or intramucosal adenocarcinoma. Kaplan-Meier analysis of CEIM and CED was performed. Hazard ratios for CEIM stratified by baseline risk factors were calculated. RESULTS: Among 138 subjects with low-grade dysplasia (24%), high-grade dysplasia (49%), and intramucosal adenocarcinoma (27%), 34% received prior RFA therapy. Subjects received a median of 2 SCT sessions. Adverse events were uncommon, with 5.5% reporting strictures and 0.7% a perforation. Rates of CEIM and CED, respectively, were 66% and 84% after 2 years and 67% and 92% after 3 years. In RFA-naïve patients, CEIM was 77% and CED was 96% at 3 years. Increasing BE length (per centimeter: adjusted hazard ratio, 0.90; 95% confidence interval, 0.83-0.96) and prior treatment with RFA (adjusted hazard ratio, 0.39; 95% confidence interval, 0.22-0.69) were associated with a lower rate of CEIM. Recurrence occurred in 8.8% (n = 6) at a mean follow-up of 2.5 years after CEIM. CONCLUSION: In this largest reported prospective cohort, liquid nitrogen SCT was safe and effective for the treatment of dysplastic and neoplastic BE. Response was lower in those with prior failed RFA; in that cohort, approximately 50% attained CEIM at 3 years.


Subject(s)
Adenocarcinoma , Barrett Esophagus , Esophageal Neoplasms , Nitrogen , Registries , Humans , Barrett Esophagus/surgery , Barrett Esophagus/pathology , Barrett Esophagus/therapy , Male , Female , Middle Aged , Aged , Prospective Studies , Adenocarcinoma/pathology , Adenocarcinoma/therapy , Adenocarcinoma/surgery , Esophageal Neoplasms/therapy , Esophageal Neoplasms/pathology , Esophageal Neoplasms/surgery , Nitrogen/therapeutic use , Treatment Outcome , Cryosurgery/methods , Metaplasia , Cryotherapy/methods , Esophagoscopy/methods , Adult
15.
Endoscopy ; 56(7): 503-511, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38503302

ABSTRACT

BACKGROUND: Cold resection of colorectal lesions is widely performed because of its safety and effectiveness; however, it remains uncertain whether adding submucosal injection could improve the efficacy and safety. We aimed to compare cold endoscopic mucosal resection (C-EMR) versus cold snare polypectomy (CSP) for colorectal lesions. METHODS: We performed a systematic review of randomized controlled trials (RCTs) identified from PubMed, Cochrane Library, and Embase. The primary outcome was complete resection. Secondary outcomes were procedure time, en bloc resection, and adverse events (AEs). Prespecified subgroup analyses based on the size and morphology of the polyps were performed. The random-effects model was used to calculate the pooled risk ratio (RR) and mean difference, with corresponding 95%CIs, for dichotomous and continuous variables, respectively. Heterogeneity was assessed using the Cochran Q test and I 2 statistics. RESULTS: 7 RCTs were included, comprising 1556 patients, with 2287 polyps analyzed. C-EMR and CSP had similar risk ratios for complete resection (RR 1.02, 95%CI 0.98-1.07), en bloc resection (RR 1.08, 95%CI 0.82-1.41), and AEs (RR 0.74, 95%CI 0.41-1.32). C-EMR had a longer procedure time (mean difference 42.1 seconds, 95%CI 14.5-69.7 seconds). In stratified subgroup analyses, the risk was not statistically different between C-EMR and CSP for complete resection in polyps<10 mm or ≥10 mm, or for complete resection, en bloc resection, and AEs in the two groups among nonpedunculated polyps. CONCLUSIONS: The findings of this meta-analysis suggest that C-EMR has similar efficacy and safety to CSP, but significantly increases the procedure time. PROSPERO: CRD42023439605.


Subject(s)
Colonic Polyps , Endoscopic Mucosal Resection , Randomized Controlled Trials as Topic , Humans , Endoscopic Mucosal Resection/methods , Endoscopic Mucosal Resection/adverse effects , Colonic Polyps/surgery , Colonic Polyps/pathology , Operative Time , Colorectal Neoplasms/surgery , Colorectal Neoplasms/pathology , Colonoscopy/methods , Cryosurgery/methods , Cryosurgery/adverse effects , Treatment Outcome
16.
Curr Opin Pulm Med ; 30(4): 337-345, 2024 07 01.
Article in English | MEDLINE | ID: mdl-38682600

ABSTRACT

PURPOSE OF REVIEW: This review article focuses on bronchoscopic treatment of early-stage peripheral lung cancer. RECENT FINDINGS: Bronchoscopic treatment modalities have garnered considerable attention for early-stage lung cancer. Studies using photodynamic therapy, thermal vapor ablation, laser ablation, cryoablation, and intra-tumoral injection have recently been published. However, the evidence supporting these approaches largely derives from single-arm studies with small sample sizes. Based on the IDEAL-D framework, no technology has progressed passed the idea phase (1). The main weakness of these technologies to date is lack of evidence suggesting they can achieve local control. Presently, no bronchoscopic intervention for lung cancer has sufficient data to warrant its use as part of the standard of care. SUMMARY: Despite notable progress, current technologies remain suboptimal, and there is insufficient evidence to support their use outside of a research setting.


Subject(s)
Bronchoscopy , Lung Neoplasms , Neoplasm Staging , Humans , Lung Neoplasms/pathology , Lung Neoplasms/therapy , Lung Neoplasms/surgery , Bronchoscopy/methods , Photochemotherapy/methods , Laser Therapy/methods , Cryosurgery/methods , Treatment Outcome
17.
J Vasc Interv Radiol ; 35(1): 36-44, 2024 01.
Article in English | MEDLINE | ID: mdl-37805172

ABSTRACT

PURPOSE: To assess the feasibility and safety of using computed tomography (CT) guidance for ablation of prostate cancer in the salvage setting. MATERIALS AND METHODS: This institutional review board-approved retrospective study of consecutive patients who presented with prostate cancer recurrence and underwent percutaneous CT-guided cryoablation was conducted between July 2020 and September 2022. A total of 18 patients met the inclusion criteria, and a total of 19 procedures were performed. Demographic details; preablation and postablation urinary, rectal, and erectile function assessment; procedure details; and preoperative and postoperative imaging findings and prostate-specific antigen (PSA) values were recorded. RESULTS: The mean treated tumor size was 15.7 mm ± 6.2. Technical success was achieved in 18 of the 19 procedures (94.7%), with 1 procedure aborted due to inability to obtain a safe plane. The mean follow-up time was 10.0 months (range, 2.3-26.7 months) at the time of manuscript preparation. The mean PSA before ablation was 8.1 ng/mL ± 9.3, and postablation PSA nadir was 2.6 ng/mL ± 4.0 (P = .002). Of the 18 patients who had postoperative imaging, 16 (88.9%) had a complete response (ie, no evidence of residual disease), and 2 (11.1%) patients had residual disease. Overall, 16 (88.9%) of the 18 treated patients demonstrated a PSA and/or imaging response to ablation. Mild adverse events occurred in 4 (22%) of the 18 cases. CONCLUSIONS: CT-guided cryoablation appears to be a technically feasible, safe option for treating locally recurrent prostate cancer.


Subject(s)
Cryosurgery , Prostatic Neoplasms , Male , Humans , Prostate-Specific Antigen , Cryosurgery/adverse effects , Cryosurgery/methods , Retrospective Studies , Feasibility Studies , Treatment Outcome , Prostatic Neoplasms/diagnostic imaging , Prostatic Neoplasms/surgery , Tomography, X-Ray Computed , Neoplasm Recurrence, Local/surgery
18.
J Vasc Interv Radiol ; 35(4): 533-540, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38219902

ABSTRACT

PURPOSE: To assess the safety and technical success of percutaneous cryoablation (PCA) without pyeloperfusion in 94 patients with central renal tumors. MATERIALS AND METHODS: A retrospective review of all central renal tumors treated by PCA without pyeloperfusion was performed. Central tumors were defined as those involving the renal sinus fat on preprocedural cross-sectional imaging. Patient demographics and baseline tumor characteristics were recorded. The details of the PCA procedure, primary and secondary technical success, rates of local recurrence, adverse events (AEs), cancer-specific survival (CSS), and overall survival (OS) were compiled. RESULTS: Ninety-four patients (48 females [51%]; mean age, 68.2 years [range, 38-87 years]) with 94 central renal tumors were included. The mean maximal tumor diameter and mean RENAL nephrometry score were 37 mm (range, 15-67 mm) and 8 (range, 4-11), respectively. Primary technical success was achieved in 94% (n = 88) of procedures. Of the patients who did not achieve primary technical success, 3 underwent successful repeat PCA (secondary technical success, 97%; n = 91/94). The other 3 patients were surveilled for residual disease. Twenty-four patients (26%) required hydrodissection during PCA. Six patients (6%) experienced major AEs after PCA including hemorrhage requiring embolization (n = 3), hemorrhage requiring transfusions with admission (n = 2), and perinephric abscess necessitating drain placement (n = 1). Twenty-two patients (23%) experienced minor AEs. Nine patients (10%) experienced local recurrence during the follow-up period. OS was 94% (n = 88/94), whereas CSS was 98% (n = 92/94) during the study follow-up period (mean, 16 months [range, 1-102 months]). CONCLUSIONS: PCA of central renal tumors appears to be safe with high rates of technical success, even without the use of pyeloperfusion.


Subject(s)
Carcinoma, Renal Cell , Cryosurgery , Kidney Neoplasms , Female , Humans , Aged , Carcinoma, Renal Cell/surgery , Cryosurgery/adverse effects , Cryosurgery/methods , Feasibility Studies , Treatment Outcome , Kidney Neoplasms/diagnostic imaging , Kidney Neoplasms/surgery , Retrospective Studies , Hemorrhage/etiology
19.
J Vasc Interv Radiol ; 35(2): 226-231, 2024 Feb.
Article in English | MEDLINE | ID: mdl-37797742

ABSTRACT

PURPOSE: To assess the effectiveness and safety of cryoablation (CRA) for the treatment of recurrent or oligometastatic solid tumors located in the thoracoabdominal soft tissues. MATERIALS AND METHODS: Twenty-two percutaneous CRA procedures performed in 19 patients to treat recurrent or oligometastatic tumors in thoracoabdominal soft tissue were retrospectively examined. All procedures were performed between January 2015 and June 2021 under ultrasound and computed tomography (CT) guidance, and the most complex procedures were performed with CT-based navigation systems. The histology of the primary tumors included colorectal adenocarcinoma, squamous cell lung carcinoma, pancreatic adenocarcinoma, renal cell carcinoma, and hepatocellular carcinoma. Adverse events, technical success, and local tumor control were analyzed. RESULTS: The mean age of the patients was 66.5 years, with a mean tumor size of 24.8 mm. The mean time of the procedures was 68 minutes, with a mean number of 2.5 cryoprobes used. Hydrodissection was performed in 63% of the procedures to protect the surrounding anatomical structures. The mean size of the ice ball, measured on axial CT scans at the end of the procedures, was 43.5 mm. No severe adverse events were observed. Technical success was achieved in all cases. Three patients experienced local tumor progression (2 residual disease and 1 recurrence), which were successfully treated with a second CRA procedure. CONCLUSIONS: Percutaneous CRA is a safe and effective therapy in selected cases of recurrent or oligometastatic tumors in the thoracoabdominal soft tissues.


Subject(s)
Adenocarcinoma , Cryosurgery , Kidney Neoplasms , Liver Neoplasms , Lung Neoplasms , Pancreatic Neoplasms , Humans , Aged , Treatment Outcome , Cryosurgery/adverse effects , Cryosurgery/methods , Adenocarcinoma/surgery , Retrospective Studies , Pancreatic Neoplasms/surgery , Kidney Neoplasms/diagnostic imaging , Kidney Neoplasms/surgery , Liver Neoplasms/diagnostic imaging , Liver Neoplasms/surgery , Liver Neoplasms/etiology , Lung Neoplasms/surgery
20.
Pediatr Blood Cancer ; 71(1): e30722, 2024 Jan.
Article in English | MEDLINE | ID: mdl-37843290

ABSTRACT

BACKGROUND: Intercostal nerve cryoablation (INC) has shown promise as an adjunct method for analgesia in adults undergoing thoracotomy, but has yet to be widely used in children for this indication. We hypothesize that INC decreases opioid utilization in children undergoing thoracotomy for cancer operations. METHODS: A retrospective review was performed of children who underwent thoracotomy for cancer diagnosis at a freestanding children's hospital from 2018 to 2023. Patient characteristics, intraoperative data, and data on clinical course were collected. Patients were divided into those who underwent INC and those who underwent routine care for comparison. RESULTS: Twenty-six patients underwent 38 procedures at a median age of 16 years (range 5-21 years). INC was performed in 23 cases over a median of five intercostal levels (range 2-7). Total oral morphine equivalents during inpatient admission were significantly lower in INC patients (137.6 vs. 514.5 mg, p = .002). Routine care patients were more likely to be discharged with an opioid prescription (30.4% vs. 80.0%, p = .008). Length of stay was similar between patients with INC and routine care (4 vs. 5 days, p = .15). There were no differences in rates of reoperation or 30-day re-admission (emergency department or inpatient). CONCLUSTIONS: INC is a feasible and safe adjunct for children undergoing thoracotomy for cancer. INC is associated with reduced postoperative opioid utilization with respect to both inpatient use and outpatient prescriptions.


Subject(s)
Cryosurgery , Neoplasms , Adult , Humans , Child , Child, Preschool , Adolescent , Young Adult , Analgesics, Opioid/therapeutic use , Cryosurgery/methods , Thoracotomy , Intercostal Nerves/surgery , Pain, Postoperative/drug therapy , Pain, Postoperative/surgery , Neoplasms/surgery , Retrospective Studies
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