Cryoablation Catheter Used in the Surgical Treatment of Atrial Fibrillation May Treat Chest Tube Pain: Engin Technique.

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.

Safety and efficacy of the second-generation cryoballoon for left atrial appendage electrical isolation in canines.

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.

Transbronchial Cryobiopsy Using the Ultrathin 1.1-mm Cryoprobe with Ultrathin Bronchoscopy under Radial Endobronchial Ultrasound Guidance for Diagnosis of Peripheral Pulmonary Lesions.

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.

Application of local anaesthesia and cryosurgery for eyelid masses in dogs.

BACKGROUND: Eyelid mass removal and cryotherapy application using only local anaesthesia and restraint may benefit patients with high anaesthesia risks. OBJECTIVE: To evaluate and validate cryosurgery application using the CryoPen XL® on palpebral masses under local anaesthesia for patients not suitable for general anaesthesia. METHODS: Thirty patients underwent the procedure between November 2015 and April 2020. The procedure steps were as follows: skin preparation and local anaesthesia of the affected eyelid; debulking by resection and/or squeezing out the inspissated material; cryosurgery and post-operative care using topical medication, antibiotics and anti-inflammatory ointment. The medical records of the patients who underwent the operation were evaluated. Moreover, a telephonic survey with the pet owners was performed to determine recurrence, time to recurrence, survivability and side effects. RESULTS: Among the 30 owners, 29 responded to the survey. Ten (10/38, 26.3%) masses recurred with an average time to recurrence of 6.0 months. The estimated average depths for all, non-recurred, and recurred masses were 1.89, 1.88 and 1.90 mm, respectively. The average recurrence rate and time to recurrence were higher and earlier, respectively, than previously reported values. However, no patient presented intra- or post-operative complications. CONCLUSION: These findings suggest that local anaesthesia and cryosurgery using the CryoPen XL® can be used in patients with eyelid masses who are not suitable for general anaesthesia. Compared with the surgical eyelid mass removal and blepharoplasty procedure, the reported procedure is time- and cost-effective, with the additional benefit of not requiring general anaesthesia.

Increased procedural safety of cryoballoon pulmonary vein isolation with a double 120 s freeze protocol.

BACKGROUND: Recently a double 120 s freeze cryoballoon (CB) pulmonary vein isolation (PVI) protocol proved to be non inferior to a double 240 s freeze protocol in terms of atrial fibrillation (AF) recurrences. We hypothesized that this approach could also result in an increased procedure safety. METHODS: Eighty consecutive patients treated with a double 120 s freeze protocol (Group CB120) were compared with 80 previous consecutive patients treated with a single 240 s freeze protocol (Group CB240). Procedures were performed with a temperature probe to monitor the luminal esophageal temperature (LET), using a cut off for cryoenergy interruption of 15°C. During ablation at the septal pulmonary veins (PVs), the phrenic nerve (PN) function was monitored by pacing. RESULTS: In CB120 and CB240 the rate of single shot isolation was similar in all PVs. Time to isolation was not different between the two groups. Mean minimal esophageal temperature was lower in LSPV and LIPV of the CB240 group. A total of 4/80 patients (5%) of the CB120 group experienced a PN injury, but no persistent form was recorded; 11/80 patients (14%) of the CB240 group experienced a PN injury, three in a persistent form (p = .10). A LET <15°C was recorded in 3/80 patients (4%) in the CB120 group and in 16/80 patients (20%) in the CB240 group (p < .01). Composite rate of energy-related safety events (LET <15°C and PN injury) was significantly lower in the CB120 (34% vs. 9%, p < .01). CONCLUSIONS: Safety of second generation CB PVI can be increased using a double 120 s freeze protocol.

Cryo-balloon catheter localization in X-Ray fluoroscopy using U-net.

PURPOSE: Automatic identification of interventional devices in X-ray (XR) fluoroscopy offers the potential of improved navigation during transcatheter endovascular procedures. This paper presents a prototype implementation of fully automatic 3D reconstruction of a cryo-balloon catheter during pulmonary vein isolation (PVI) procedures by deep learning approaches. METHODS: We employ convolutional neural networks (CNN) to automatically identify the cryo-balloon XR marker and catheter shaft in 2D fluoroscopy during PVI. Training data are generated exploiting established semiautomatic techniques, including template-matching and analytical graph building. A first network of U-net architecture uses a single grayscale XR image as input and yields the mask of the XR marker. A second network of the similar architecture is trained using the mask of the XR marker as additional input to the grayscale XR image for the segmentation of the cryo-balloon catheter shaft mask. The structures automatically identified in two 2D images with different angulations are then used to reconstruct the cryo-balloon in 3D. RESULTS: Automatic identification of the XR marker was successful in 78% of test cases and in 100% for the catheter shaft. Training of the model for prediction of the XR marker mask was successful with 3426 training samples. Incorporation of the XR marker mask as additional input for the model predicting the catheter shaft allowed to achieve good training result with only 805 training samples. The average prediction time per frame was 14.47 ms for the XR marker and 78.22 ms for the catheter shaft. Localization accuracy for the XR marker yielded on average 1.52 pixels or 0.56 mm. CONCLUSIONS: In this paper, we report a novel method for automatic detection and 3D reconstruction of the cryo-balloon catheter shaft and marker from 2D fluoroscopic images. Initial evaluation yields promising results thus indicating the high potential of CNNs as alternatives to the current state-of-the-art solutions.

Experimental Investigation of Cryoneedle Heating during MR-Guided Cryoablation in Ex Vivo Tissue Samples at 1.5-Tesla.

PURPOSE: To investigate cryoneedle heating risks during magnetic resonance (MR)-guided cryoablation and potential strategies to mitigate these risks. MATERIALS AND METHODS: Ex vivo experiments were performed on a 1.5-Tesla (T) MR scanner using an MR conditional cryoablation system on porcine tissue phantoms. Cryoneedles were placed inside the tissue phantom either with or without an angiocatheter. Typical cryoneedle geometric configurations (including gas supply line) encountered in clinical procedures with low to high expected heating risks were investigated. Up to 4 fiber optic temperature sensors were attached to the cryoneedle/angiocatheter to measure the MR-induced cryoneedle heating at different locations during MR with different estimated specific absorption rates (SARs). The impact of cryoneedle heating on cryoablation treatment was studied by comparing temperature changes during 10-min freeze-thaw cycles with and without MR. RESULTS: Rapid temperature increases of >100 °C in < 2 minutes were observed during MR with a SAR of 2.1 W/kg. The temperature changes during a typical freeze-thaw cycle were also affected by cryoneedle heating when MR was used to monitor the ice-ball evolution. The observed cryoneedle heating was affected by multiple factors; including cryoneedle geometric configurations, sequence SAR, whether an angiocatheter was used, and whether the cryoneedle was connected to the rest of the cryoablation system. CONCLUSIONS: The ex vivo experiments demonstrated that MR could induce significant cryoneedle heating risks. Furthermore, MR-induced cryoneedle heating can affect temperatures in the ice-ball evolution during the freeze-thaw cycle. Several practical strategies to reduce the cryoneedle heating have been proposed.

Long-term course of phrenic nerve injury after cryoballoon ablation of atrial fibrillation.

While phrenic nerve palsy (PNP) due to cryoballoon pulmonary vein isolation (PVI) of atrial fibrillation (AF) was transient in most cases, no studies have reported the results of the long-term follow-up of PNP. This study aimed to summarize details and the results of long-term follow-up of PNP after cryoballoon ablation. A total of 511 consecutive AF patients who underwent cryoballoon ablation was included. During right-side PVI, the diaphragmatic compound motor action potential (CMAP) was reduced in 46 (9.0%) patients and PNP occurred in 29 (5.7%) patients (during right-superior PVI in 20 patients and right-inferior PVI in 9 patients). PNP occurred despite the absence of CMAP reduction in 0.6%. The PV anatomy, freezing parameters and the operator's proficiency were not predictors of PNP. While PNP during RSPVI persisted more than 4 years in 3 (0.6%) patients, all PNP occurred during RIPVI recovered until one year after the ablation. However, there was no significant difference in the recovery duration from PNP between PNP during RSPVI and RIPVI. PNP occurred during cryoballoon ablation in 5.7%. While most patients recovered from PNP within one year after the ablation, PNP during RSPVI persisted more than 4 years in 0.6% of patients.

Adverse Events Associated With ClariFix Posterior Nasal Nerve Cryoablation: A MAUDE Database Analysis.

Posterior nasal nerve (PNN) cryoablation is a novel surgical technique used to address chronic rhinitis. The purpose of this study is to review the medical device reports (MDRs) submitted to the Food and Drug Administration's (FDA) Manufacturer and User Device Facility Experience (MAUDE) database to identify adverse events related to the use of ClariFix, a device designed for office-based cryosurgical ablation of the PNN. A total of 12 adverse events associated with ClariFix from January 2017 to August 2020 were identified and analyzed. The most common adverse events associated with ClariFix PNN cryoablation include epistaxis and nasal swelling. Further studies are needed to clarify whether PNN cryoablation is associated with epistaxis in certain populations.

Endobronchial Balloon Blockers: A Retrospective Analysis of Their Implementation for Use in Transbronchial Cryobiopsy Under Conscious Sedation.

INTRODUCTION: Transbronchial lung cryobiopsy (TBLC) is a promising technique that is evolving as a standard diagnostic procedure in the diagnosis of interstitial lung disease. However, there are a variety of non-standardised techniques adopted for this procedure. We aim to describe our approach to TBLC with balloon blockade under conscious sedation (CS). METHODS: We performed a retrospective analysis of patients undergoing TBLC using flexible bronchoscopy under CS in our institution over the calendar years 2017-2018; before and after a transition to the use of endobronchial balloon blockers (EBB) in 2017. RESULTS: 25 patients underwent transbronchial cryobiopsy during the study period. Of these; 12 procedures used EBB. EBB subjects had significantly less moderate or severe airway bleeding (8.3% vs 38.5%) despite higher biopsy rates in the EBB group, 2.9 (2-4) vs 2.4 (1-4) in the non-EBB group. No severe airway bleeding occurred in the EBB group. A multidisciplinary meeting (MDM) confirmed diagnosis was achieved in 88% of patients. 10/12 subjects (83%) in the EBB group and 12/13 subjects (92%) in the non-EBB group (p = 0.5). CONCLUSION: Our institution is novel in using EBB as standard during TBLC specifically under CS with flexible bronchoscopy in the bronchoscopy suite. This retrospective analysis demonstrates that EBB enhances the safety profile of performing TBLC under CS and did not appear to impact diagnostic yield or patient safety.

Occlusion tool software for pulmonary vein occlusion verification in atrial fibrillation cryoballoon ablation.

BACKGROUND: Optimal pulmonary vein (PV) occlusion, usually verified with selective contrast injection, is mandatory to obtain an effective PV isolation during cryoballoon (CB) ablation. AIM OF THE STUDY: The purpose of this study was to verify the feasibility and the accuracy of a new dielectric sensing system in assessing PV occlusion during CB ablation in patients with atrial fibrillation (AF). METHODS: We enrolled 28 consecutive patients with paroxysmal or persistent AF. After transseptal access, a detailed image reconstruction of left atrium and PVs was achieved with an octapolar or decapolar mapping catheter (Achieve catheter, Medtronic Inc.) and KODEX-EPD system (EPD Solutions, a Philips company). The degree of PV occlusion with the inflated Arctic Front Advance Cryoballoon (Medtronic Inc.) was verified using the new "occlusion tool" software module (EPD Solutions, a Philips company) and compared to an angiogram obtained with contrast medium injection in each PV. RESULTS: A total of 105 PV CB occlusion were tested. The new occlusion tool software module showed a 91% sensitivity and 76% specificity in assessing a complete PV occlusion verified with contrast medium injection. The positive predictive value was 80%, and the negative predictive value was 88.6%. Mean procedure time was 81 ± 17 minutes. Mean fluoroscopy time was 6 ± 2 minutes. No 30-day complications were observed. CONCLUSION: The new dielectric imaging system was able to assess the degree of PV occlusion during a CB ablation with good sensitivity and specificity.

Multifocal Cryoballoon Ablation for Eradication of Barrett's Esophagus-Related Neoplasia: A Prospective Multicenter Clinical Trial.

INTRODUCTION: Ablation of Barrett's esophagus (BE) is the preferred approach for the treatment of neoplasia without visible lesions. Limited data on cryoballoon ablation (CBA) suggest its potential clinical utility. We evaluated the safety and efficacy of CBA in a multicenter study of patients with neoplastic BE. METHODS: In a prospective clinical trial, 11 academic and community centers recruited consecutive patients with BE of 1-6 cm length and low-grade dysplasia, high-grade dysplasia (HGD), or intramucosal adenocarcinoma (ImCA) confirmed by central pathology. Patients with symptomatic pre-existing strictures or visible BE lesions had dilation or endoscopic mucosal resection (EMR), respectively, before enrollment. A nitrous oxide cryoballoon focal ablation system was used to treat all visible columnar mucosa in up to 5 sessions. Study end points included complete eradication of all dysplasia (CE-D) and intestinal metaplasia (CE-IM) at 1 year. RESULTS: One hundred twenty patients with BE with ImCA (20%), HGD (56%), or low-grade dysplasia (23%) were enrolled. In the intention-to-treat analysis, the CE-D and CE-IM rates were 76% and 72%, respectively. In the per-protocol analysis (94 patients), the CE-D and CE-IM rates were 97% and 91%, respectively. Postablation pain was mild and short lived. Fifteen subjects (12.5%) developed strictures requiring dilation. One patient (0.8%) with HGD progressed to ImCA, which was successfully treated with EMR. Another patient (0.8%) developed gastrointestinal bleeding associated with clopidogrel use. One patient (0.8%) had buried BE with HGD in 1 biopsy, not confirmed by subsequent EMR. DISCUSSION: In patients with neoplastic BE, CBA was safe and effective. Head-to-head comparisons between CBA and other ablation modalities are warranted (clinicaltrials.gov registration NCT02514525).

Evaluation of the Safety and Efficacy of a Low-Temperature Plasma Surgical System for Pterygium.

PURPOSE: Surgical excision is the standard treatment for pterygium. This study was conducted to evaluate the safety and efficacy of a novel technique using low-temperature plasma (LTP) for excision and hemostasis in pterygium surgery. METHODS: A prospective, comparative, and randomized clinical trial was conducted on 60 patients (60 eyes) undergoing pterygium excision with conjunctival autografts using fibrin glue. Patients were equally divided into the following 2 groups: a control group and a LTP group. Postoperative follow-up visits were scheduled on day 1, week 1, and months 1 and 3, and recurrence was evaluated at 1 year. Patients were examined for operative time, best corrected visual acuity, conjunctival autograft inflammation (CAI), graft stability (GS), pain, recurrence, and final appearance. Factors related to pterygium recurrence and final appearance were analyzed. RESULTS: Mean operative times were shorter in the LTP group (16.7 ± 3.4 min) than those in the control group (20.1 ± 4.7 min, P = 0.002). LTP eyes had milder CAI than control eyes at postoperative day 1 (P = 0.000) and week 1 (P = 0.000). Patients in the LTP group exhibited better GS (P = 0.01) and milder pain (P = 0.04) than those in the control group on day 1. Two control patients (6.7%) and no (0%) LTP patients experienced recurrence (P = 0.08). GS and CAI were the significant factors contributing to recurrence (GS: R = 0.425, P = 0.001; CAI: R = 0.309, P = 0.016). CONCLUSIONS: LTP to replace surgical blades and disposable cautery for ablation and hemostasis is safe and efficient for pterygium surgery, resulting in shorter operative time, milder inflammation, and better graft stability without increasing complication risk.

Liquid Nitrogen-Based Cryoablation in In Vivo Porcine Tissue: A Pilot Study.

INTRODUCTION: Liquid nitrogen-based cryoablation induces freezing evenly throughout the probe tip surface, resulting in larger ablation volumes and faster treatment times. The purpose of this preliminary investigation is to determine the efficacy of the liquid nitrogen-based Visica2 Cryoablation System (Sanarus Technologies, Pleasanton, CA) in in vivo porcine kidney, liver, and fibro-fatty tissue. METHODS: Ablations were performed under ultrasound guidance in 4 Yorkshire pigs. The target lesion cross-section width (W) and depth (D) were 1 cm for liver (n=8), kidney (n=4), and head-neck (n=5) and 2 cm for kidney (n=4).  Expected axial length (L) of the resulting lesion is approximately 4 cm.  After three-day survival, the ablated tissue was harvested and histologically analysed. The mean width and depth were compared with the target diameter using a one-sample t-test. RESULTS: All animals survived the procedure. For the 1 cm target, mean dimensions (L x W x D) were 3.8±1.5 x 1.7±0.3 x 1.7±0.7 for liver, 3.0±0.5 x 2.0±0.4 x 1.7±0.6 for kidney, and 3.3±0.8 x 1.8±0.4 x 1.8±0.4 for head-neck.  Mean width and depth were significantly greater than desired dimension.  For the 2 cm target, mean dimensions were 3.2±0.5 x 3.1±0.8 x 1.9±0.7.  Mean width and depth were not significantly different to desired target. CONCLUSION: Our preliminary results show that the Visica2 liquid nitrogen-based cryoablation system can efficiently and reproducibly create ablation volumes in liver, kidney, and fibro-fatty tissue within 4 minutes and 12 minutes for 1cm and 2cm targeted diameters, respectively. Further investigation is necessary to determine the optimal freeze-thaw-freeze protocol for larger ablation volumes.
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Estimation of the stable frozen zone volume and the extent of contrast for a therapeutic substance.

BACKGROUND: In biomedical science and clinical practice, an estimation of the stable frozen zone volume and distribution of concentration fields of injected diagnostic and healing solutions in the tissues of living organisms is of great importance and does not currently have any mathematical solution aimed at its precise evaluation. OBJECTIVE: The aim of this research is the estimation of the stable frozen zone volume at ultra-low temperatures as well as the distribution of temperature areas and concentration fields of injected diagnostic and healing substances in vitro. The results can improve our understanding of the stable frozen zone volume and the extent of contrast for a therapeutic substance. MATERIALS AND METHODS: A cryogenic zone (ice ball) was generated at -180°C using liquid nitrogen without any difficulties in vitro. The effects of freeze-thaw processes using ultra-low temperature and the cryogenic response of a 1.5% gelatin solution in water (%g/v) kept at a constant temperature of 20°C and continuously stirred were mathematically analyzed. The stable frozen zone volume was illustrated in vitro and measured in terms of its length, depth and cryogenic margin using a standard medical ruler and Vernier caliper after a freezing period at -180°C, using liquid nitrogen to provide cooling and freezing of a small portion of this solution in the vessel at room temperature (20°C). Round-shaped cryoprobes with diameters of 15 mm and 50 mm were applied to create a frozen zone volume in vitro. A single cryoprobe was used per procedure. The sample exposure time was 3 min. After this time, the volume of the frozen region remains unchanged, which indicates that the equilibrium stationary state has been reached. The experimental design, cryogenic procedure and freeze-thaw processes of the hemisphere were described and illustrated in vitro item by item. The statistical analysis manifested significant differences that were found between the 50 mm and 15 mm cryoprobes with regards to the freezing diameter, depth, and cryogenic margin (P < 0.001). RESULTS: An illustrated analytical mathematical solution of equations determined the stable frozen zone volume and the radius of the sphere of the frozen medium in the equilibrium stationary state. The resulting assessment provided the basis for the creation of mini- and micro-cryoprobes as well as cryoneedles for local tissue freezing in living biological structures. A solution to the equations was obtained under the boundary conditions with a set stable temperature value on the boundary surface of the cryoprobe as well as at the surface well-away from it, where the temperature is equal to the stable temperature of the environment. For example, this solution gives that in the case of a hemispherical cryoprobe radius of 1 mm, the frozen zone volume was more than three orders of magnitude greater than the volume of the cryoprobe itself and was equal to approximately 4 cm3. The determination of the fractal dimension can consider the individual characteristics of the spread of the contrast medium or therapeutic substance(s) in living tissue. Based on fractal theory, our innovative mathematical formulas allow for the assessment of the effective distribution of contrast medium in living biological structures, specifically for tissues assessed for diagnostic purposes, and they enable the selection of an optimal treatment strategy in medical practice. CONCLUSION: A simple mathematical approach to solving the problems of assessing the stable frozen zone volume and distribution of temperature areas and concentration fields of injected diagnostic and healing substances in living biological structures, particularly living tissue in vitro, is presented in this study. The expressed quantitative mathematical formulas determine the stable stationary frozen zone volume and provide the basis for the creation of mini- and micro-cryoprobes. The application of fractal theory is proposed for assessing the distribution efficiency of contrast medium and therapeutic substance(s) in living biological structures for diagnostic purposes and for selecting a compassionate treatment strategy in medical professional practice.

Acute Phase Response and Postprocedural Evaluation of Open and Laparoscopic Cryoablation Procedures in Porcine Pancreases.

OBJECTIVES: Cryoablation is a potentially less invasive locoregional ablation modality. Although cryoablation has been used to treat malignancy in various organs, a limited application of this modality in the pancreas has been reported. METHODS: Acute phase response assessments and postprocedural course evaluations of 2 experimental locoregional ablation methods were conducted. In one method, open and laparoscopic cryoablation of a porcine pancreas using an argon-helium gas-based cryoablation system and monitoring of tissue temperature during the procedure were performed. In the other method, open cryoablation of a porcine pancreas using liquid nitrogen was performed. The animals were evaluated postoperatively. RESULTS: The size of the cryolesion was larger in the second treatment than in the first. Laparoscopic cryoablation was associated with the formation of an iceball, which possibly affected the surrounding structures. The ablated region was adequately cooled with 10 minutes of freeze/repeat cycles. The area cooled to a temperature of less than -40°C was approximately half the size of the cryolesion in diameter. The swine used for the evaluation of the postprocedural course survived 3 weeks after the procedure with a temporal elevation of the serum lipase level. CONCLUSIONS: Cryoablation of the pancreas was experimentally practicable without severe complications under direct or laparoscopic vision.

Cryoballoon Ablation and Bipolar Voltage Mapping in Patients With Left Atrial Appendage Occlusion Devices.

Left atrial appendage occlusion is utilized as a second line therapy to long-term oral anticoagulation in appropriately selected patients with atrial fibrillation (AF). We examined the feasibility of cryoballoon (CB) pulmonary vein isolation (PVI) subsequent to Watchman device implantation. The study prospectively identified patients with Watchman devices (>90 days old) who underwent CB-PVI ablation between 2018 and 2019. Twelve consecutive patients (male 50%; mean age 71 ± 9 years; CHA2DS2-VASc score 3.4 ± 1.1) underwent CB-PVI procedures after Watchman device implantation (mean 182 ± 82 days). Acute PVI was achieved in 100% of patients. All patients had evidence of complete (n = 9) or partial (n = 3) endothelialization of the surface of the Watchman device with conductive tissue properties demonstrated during electrophysiologic testing. There were no major procedure-related complications including death, stroke, pericardial effusion, device dislodgment, device thrombus, or new or increasing peri-device leak. Mean peri-device leak size (45-day postimplant: 0.06 ± 0.09 mm vs Post-PVI: 0.04 ± 0.06 mm; p = 0.61) remained unchanged. Two patients had recurrence of AF after the 90-day blanking period (13.2 ± 6.6 months). One patient underwent a redo ablation procedure for recurrent AF. This pilot study suggests the potential feasibility of CB-PVI ablation in patients with chronic Watchman left atrial appendage occlusion devices. Larger prospective studies are needed to confirm the clinical efficacy and safety of this approach.

Transbronchial biopsy results according to diffuse interstitial lung disease classification. Cryobiopsy versus forceps: MULTICRIO study.

BACKGROUND: In recent years, transbronchial cryobiopsy (TBCB) has come to be increasingly used in interventional pulmonology units as it obtains larger and better-quality samples than conventional transbronchial lung biopsy (TBLB) with forceps. No multicenter studies have been performed, however, that analyse and compare TBCB and TBLB safety and yield according to the interstitial lung disease (ILD) classification. OBJECTIVES: We compared the diagnostic yield and safety of TBCB with cryoprobe sampling versus conventional TBLB forceps sampling in the same patient. METHOD: Prospective multicenter clinical study of patients with ILD indicated for lung biopsy. Airway management with orotracheal tube, laryngeal mask and rigid bronchoscope was according to the protocol of each centre. All procedures were performed using fluoroscopy and an occlusion balloon. TBLB was followed by TBCB. Complications were recorded after both TBLB and TBCB. RESULTS: Included were 124 patients from 10 hospitals. Airway management was orotracheal intubation in 74% of cases. Diagnostic yield according to multidisciplinary committee results for TBCB was 47.6% and for TBLB was 19.4% (p<0.0001). Diagnostic yield was higher for TBCB compared to TBLB for two groups: idiopathic interstitial pneumonias (IIPs) and ILD of known cause or association (OR 2.5; 95% CI: 1.4-4.2 and OR 5.8; 95% CI: 2.3-14.3, respectively). Grade 3 (moderate) bleeding after TBCB occurred in 6.5% of patients compared to 0.8% after conventional TBLB. CONCLUSIONS: Diagnostic yield for TBCB was higher than for TBLB, especially for two disease groups: IIPs and ILD of known cause or association. The increased risk of bleeding associated with TBCB confirms the need for safe airway management and prophylactic occlusion-balloon use. TRIAL REGISTRATION: clinicaltrials.gov identifier: NCT02464592.

Cryosurgical ablation for treatment of common warts on the nasal vestibule.

BACKGROUND: Common warts rarely occur on the nasal vestibule. It should be treated more carefully than other skin lesions because scar contracture results in the narrowing of the external naris, causing nasal obstruction and reducing the patient's quality of life. In this report, we introduce our method for common warts on the nasal vestibule using handheld cryoablation devise. PATIENTS AND OPERATIVE METHODS: We performed a series of four cryosurgical ablation procedures to treat common warts on the nasal vestibule. All the procedures employed a reusable handheld cryoablation device (CRY-AC®, Brymill Cryogenic Systems, Ellington, CT). RESULT: All patients were successfully treated for four to six sessions without any adverse event. CONCLUSION: Cryotherapy for common warts on nasal vestibular is easily performed in an office setting under no anesthesia without bleeding. We believe this easy and safe procedure is suitable as the first line therapy for common wart on nasal vestibular.