Provox ActiValve Research Articles

Biofilm in voice prosthesis: A prospective cohort study and laboratory tests using sonication and SEM analysis.

The objective of the study was to compare the biofilm growing pattern and its morphological extent on silicone and a teflon-like material using a sonication process and a Scanning Electron Microscope (SEM). A prospective cohort study and a laboratory study. Otolaryngology -Head and Neck surgery Department and the Microbiology Institute. The participants included fifteen laryngectomised patients with phonatory prostheses, which were removed because of device failure, and two different kinds of phonatory prostheses from the laboratory (Provox 2 and ActiValve) that were artificially colonised by Candida albicans. Tracheo-oesophageal puncture (TEP) is currently considered the gold standard for post-laryngectomy voice rehabilitation. "Leakage" represents the most common cause of substitution and is generated by biofilm colonisation of the prosthesis by mixed mycotic and bacterial agents. New biomaterials have been developed that are deemed to be more resistant to the colonisation of micro-organisms and material deformation. The devices showed colonisation by mixed bacterial flora (Staphylococci 13%, Streptococci 9%, and Haemophilus influenzae 5%) and by yeasts (Candida albicans 12%). Moreover, we observed a different distribution of biofilm layers in Provox ActiValve (22.56%) compared to Provox 2 (56.82%) after experimental colonisation by the previously isolated Candida strain. Resident microbiological species from the upper airways unavoidably colonise the polymer surfaces, and no strategies have been effective except for the manipulation of the chemical-physical properties of the device's polymer. Our study confirms that Provox ActiValve, which is made with a fluoroplastic material (teflon-like), is less subject to invitro colonisation by Candida, and thus showed a higher clinical resistance to biofilm and a longer lifespan. The sonication seems to significantly improve the knowledge of bacterial and mycotic flora in biofilm colonisation. The design of a device for the daily cleaning capable to reach and brush the oesophageal flange of the prosthesis preserving the valve mechanism could represent a practical and simple help in this still unsolved problem.

Device Life of the Tracheoesophageal Voice Prosthesis Revisited

ImportanceVoice prosthesis (VP) device life is a limiting factor of tracheoesophageal (TE) voice restoration that drives patient satisfaction, health care costs, and overall burden. Historic data suggest that TE VPs have an average device life of generally 3 to 6 months, but these data are typically derived from small samples using only 1 or 2 devices.ObjectiveTo reexamine current device life in a large, contemporary cancer hospital in the United States that uses a wide assortment of VPs.Design, Setting, and ParticipantsThis retrospective observational study included 390 laryngectomized patients with a tracheoesophageal puncture (TEP) who had VP management at MD Anderson Cancer Center between July 1, 2003, and December 31, 2013.Main Outcomes and MeasuresTracheoesophageal voice–related outcomes were: (1) device life duration to VP removal, and (2) treatment-related and prosthetic-related factors influencing device failure. Primary independent variables included treatment history (extent of surgery and radiation history), VP type (indwelling vs nonindwelling, size, specialty features), and reason for removal (leakage, complication, other). Duration was examined using Kaplan-Meier analysis. Disease, treatment, and patient-specific factors were analyzed as predictors of duration.ResultsOverall, 3648 VPs were placed in the 390 patients (median [range] age, 62 [34-92] years). Indwelling prostheses accounted for more than half (56%) of the devices placed (55%, 20-Fr diameter; 33%, 8-mm length). More than two-thirds (69%) of prostheses were removed because of leakage, while the rest were removed for other reasons. Median device life was 61 days for all prostheses. Indwelling and nonindwelling VPs had median device lives of 70 and 38 days, respectively. There was no significant difference between specialty prostheses compared with standard devices (median duration, 61 vs 70 days, respectively). The Provox ActiValve (Atos Medical) had the longest life. Neither radiation therapy nor extent of surgery had a meaningful impact on device life.Conclusions and RelevanceOur data suggest that VP duration demonstrates a lower durability than historically reported. This may reflect the intensification of treatment regimens that complicate TEP management in an era of organ preservation; however, further investigation is needed.

Biofilm formation on the Provox ActiValve: Composition and ingrowth analyzed by Illumina paired‐end RNA sequencing, fluorescence in situ hybridization, and confocal laser scanning microscopy

AbstractBackgroundThe most frequent cause of voice prosthesis failure is microbial biofilm formation on the silicone valve, leading to destruction of the material and transprosthetic leakage. The Provox ActiValve valve is made of fluoroplastic, which should be insusceptible to destruction. The purpose of this study was to determine if fluoroplastic is insusceptible to destruction by Candida species.MethodsThirty‐three dysfunctional Provox ActiValves (collected 2011–2013). Biofilm analysis was performed with Illumina paired‐end sequencing (IPES), assessment of biofilm‐material interaction with fluorescence in situ hybridization (FISH), and confocal laser scanning microscopy (CLSM).ResultsIPES (n = 10) showed that Candida albicans and Candida tropicalis are dominant populations on fluoroplastic and silicone. Microbial diversity is significantly lower on fluoroplastic. Lactobacillus gasseri is the prevalent bacterial strain on most voice prostheses. FISH and CLSM (n = 23): in none of the cases was ingrowth of Candida species present in the fluoroplastic.ConclusionFluoroplastic material of Provox ActiValve seems insusceptible to destruction by Candida species, which could help improve durability of voice prostheses. © 2015 Wiley Periodicals, Inc. Head Neck 38: E432–E440, 2016

Die Kosten für verschiedene Stimmprothesenmodelle in Abhängigkeit der durchschnittlichen Liegezeit

Voice prostheses are available in different types of architecture und from different producers. Especially the ones with antifungal properties are characterized by a high pricing. The aim of this paper is to check, whether these prices are reflected by the prosthesis life time.A Benchmarking with usage of mean lifetime and prosthesis costs. Comparing Provox 1, Provox 2, Provox Vega, Provox ActiValve, ESKA-Herrmann, Blom Singer Classic, Phonax, Blom Singer Advantage.The voice prosthesis Provox 1 offers the best price-lifetime-ratio (1.0). It's 6.7-times higher than the one of the Provox ActiValve (0.15). In addition, the classic prostheses Provox 2 (0.53), Blom Singer Classic (0.54) and ESKA-Herrmann (0.72) offer a good ratio compared to Provox 1, too.The mean lifetime of the voice prostheses do not reflect the pricing. The Provox 1 offers the best ratio and should be used as a reference in pricing the prostheses.

Determining the efficacy and cost‐effectiveness of the activalve: Results of a long‐term prospective trial

To investigate 1) whether the Provox ActiValve results in increased device-life in individuals with below average device-life, 2) whether it is cost-effective, and 3) whether it has any impact on voice-related quality of life. Prospective study. Individuals who experienced below-average tracheoesophageal prosthesis (TEP) life were studied. Individuals with persistent below-average TEP life were enrolled in the study and underwent periodic re-evaluation. The majority (73%) experienced significant improvement as a result of use of the device. Those who continued to wear the device were followed for an average of 30.45 months (range, 14.70-43.49 months) and wore a total of 31 devices over this time. They demonstrated an average increase in device-life of more than 500%, going from an average of 1.93 months with a traditional indwelling device to 10.30 months with the ActiValve. The majority of individuals found that voicing with the ActiValve was either the same or better than with their previous indwelling TEP. Voice-related quality of life was not significantly different from that of a group of controls. Overall satisfaction with the device was high, and the majority would have chosen the ActiValve in the future. Overall, there were estimated to be cost savings to third-party payers through use of the ActiValve in this population. The ActiValve is effective in increasing device-life in selected patients who have failed conservative measures. Our protocol for use of the device requires individuals to meet several usage criteria before initial placement and to return for periodic monitoring.

Tworzenie biofilmu Candida na protezach głosowych Provox®2 oraz Provox Acti Valve

Patients who underwent laryngectomy due to larynx cancer have a possibility to regain ability to speak with the use of silicone voice prosthesis. However, the lifetime of the device is limited, and last for approximately 3-6 months, mainly due to bacterial and fungal biofilm formation, that subsequently causes deterioration of the prosthesis and malfunction of the valve mechanisms. Moreover, the biofilm can be reservoir for chronic and systemic infections. The aim of the following study was to investigate Candida biofilm formation on silicone voice prosthesis. Experiments were performed using C. albicans and C. krusei fungal strains with Provox 2 and Provox Acti Valve voice prosthesis. Fungal biofilms were examined under various magnifications using SEM technique. Scanning electron microscopy revealed that Candida biofilms formed on voice prosthesis had highly heterogeneous structure and were composed of blastospores, pseudohyphae, hyphae and ,,germ tubes" encased in an extracellular material. Noticeable differences in biofilms structure depended on Candida species and type of voice prosthesis. Presented data throws light on problems concerned fungal colonization on indwelled medical devices.

Clinical phase I/feasibility study of the next generation indwelling Provox voice prosthesis (Provox Vega)

Conclusions: Provox Vega prostheses demonstrate good short-term feasibility, and their optimized airflow-resistance design offers laryngectomy patients indwelling voice prostheses with more choices in outer diameters without sacrificing (too) much in voice quality. Objectives: Technological progress enables improvement of in vitro airflow characteristics of voice prostheses and design of voice prostheses with smaller outer diameters. This could potentially improve voice quality in users of Provox2, and avoid diminished voice quality in users of prostheses with smaller outer diameters. Methods: This was a prospective clinical phase I/feasibility study of three newly designed indwelling voice prostheses (Provox Vega 22.5 (Provox2 successor), 20, and 17Fr). Assessments consisted of patients' self-reported voice and speech, perceptual evaluation, acoustic analysis, maximum phonation time, loudness, speech rate, pull-out force and adaptation of the tracheoesophageal (TE) puncture to smaller diameter voice prostheses. Vega 22.5 was assessed in 15 patients (all Provox ActiValve users, observation period 3 weeks), and 16 patients with Vega 20/17 (2 weeks each). Results: No voice prostheses problems were encountered. Half of the patients with Vega 22.5 preferred that for its better voice quality. Voice and speech were considered equal to Provox2 for Vega 20, but slightly less for Vega 17. Most TE punctures adapted well to the smaller diameter voice prostheses.

Long‐Term Results of Provox ActiValve, Solving the Problem of Frequent Candida‐ and “Underpressure”‐Related Voice Prosthesis Replacements

To assess the long-term results of the Provox ActiValve, a prosthesis for voice rehabilitation after total laryngectomy that was designed to lessen the need for frequent replacements caused by Candida and "underpressure." Retrospective assessment of device lifetime, indications for replacement, voice quality, and maintenance issues, measured by a structured trial specific questionnaire, in a cohort of 42 laryngectomized patients, experiencing a short Provox2 device lifetime (median, 21 days). The median device lifetime of Provox ActiValve, replaced for leakage through the device and those still in situ at the date of data collection (N = 32), was 337 days (mean 376 days): a statistically significant 16-fold increase compared to the Provox2 prosthesis (P < .001). In 10 patients, replacement was fistula-related (median after 86 days): esophageal pouch (N = 4), fistula granulation (N = 3), extrusion of the device (N = 2), and periprosthetic leakage (N = 1). Eighty-six percent of the patients used a special lubricant to diminish "stickiness" of the valve. Provox ActiValve was preferred by 90% of the patients who completed the trial-specific questionnaire. For patients requiring frequent device-related replacements, Provox ActiValve, also long-term, provides a true solution and thereby is a valuable addition to prosthetic voice rehabilitation.

A New Problem-solving Indwelling Voice Prosthesis, Eliminating the Need for Frequent Candida- and “Underpressure”-related Replacements: Provox ActiValve

Objectives—To develop and clinically assess a new prosthesis for voice rehabilitation after total laryngectomy that solves the problem of frequent Candida- and “underpressure”-related replacements.Material and Methods—We designed a voice prosthesis with a new valve mechanism, applying Candida-resistant fluoroplastic (Teflon-like) material for the valve and valve seat and magnets to generate an active closing force, preventing inadvertent opening of the valve during swallowing or deep inhalation. Several prototypes were tested in 13 laryngectomized patients and, subsequently, the final design was assessed in a prospective clinical trial in a cohort of 18 patients with a short device lifetime of their standard indwelling voice prosthesis (mean 30 days).Results—Prototype testing and the long-term clinical trial confirmed that the new valve material remained free of Candida growth and that the use of magnets can prevent inadvertent opening of the valve during swallowing and/or deep inhalation. This resulted in a highly significant increase in device lifetime in the 18 laryngectomized patients in the prospective trial (14-fold increase on average, range 3–39-fold; p<0.001). Lubrication with special medical-grade fluoridated silicone oil is favorable in patients who experience possible adhesion of the valve to the valve seat.Conclusions—This new voice prosthesis, the Provox ActiValve, represents a solution for patients who have the problem of requiring very frequent voice prosthesis replacements due to excessive Candida growth and/or inadvertent opening of the valve by swallowing and inhalation-related underpressure in the esophagus.